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Federalism Essay | Essay on Federalism for Students and Children in English

February 13, 2024 by Prasanna

Federalism Essay:  Federal system is the method used by various countries where the power is shared by both the central government and the local or state governments. The central government can be powerful but cannot take all the state-level decisions or even choose state leaders.

Federalism allows the citizens to participate and also helps in the overall management of the country. Thus, the role of elections is very important in federal systems.

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Long and Short Essays on Nutrition for Students and Kids in English

We are providing students with essay samples on a long essay of 500 words and a short essay of 150 words on the topic Federalism for reference.

Long Essay on Federalism 500 Words in English

Long Essay on Federalism is usually given to classes 7, 8, 9, and 10.

In federal systems, the national government has the central authority over the whole national territory, whereas the provincial or state governments have individual power within their provinces. The duties, rights, and responsibilities of the central government, as well as the state governments, are mentioned in the constitution of particular countries.

The constitution gives delegated, implied, and inherent powers to the central administrative units, whereas certain powers are reserved for the states and local governing units. The main center can make national-level decisions, whereas the states have the power to regulate laws and orders in the various areas within the state. The need for security and a common defense system against external conflicts along with the decentralization of administrative power and unequal economic development between different units of a country may necessitate the adoption of the federal government.

Federalism plays an important role in unifying states with common cultural and historical background. The factor of geographical proximity is an important precondition for the formation of a federation. The countries must have enough economic resources to adopt the federal system.

Except for China, the seven other largest countries of the world, such as the United States of America, Canada, Brazil, Russia, Australia, Argentina, and India, have federal systems. Austria, Belgium, Ethiopia, Germany, Malaysia, Mexico, Nigeria, Pakistan, Switzerland, the UAE, and Venezuela have also adopted federalism.

There are various types of federalism like dual (sovereignty is divided), asymmetric (differential autonomy of states), cooperative (federal, central, and state governments operate cooperatively), competitive (central government competes with state governments and vice versa), and creative (federal government provides for the needs of the states).

On May 25th, 1787, at the Philadelphia convention, the idea of a federal system was first proposed. The advocates of the federal system were Alexander Hamilton, James Madison, and George Washington, who attempted to balance order with liberty and suggested various reasons for the formation of a federalist system which included prevention of tyranny, increasing participation in politics and functioning of the states for new ideas and developments.

In the USA, after the formation of the country and the American Civil War, the national government came into power with the rise of dual and state-centered federalism along with the origin of neo-federalism. In France, the whole plan of the federal government was to weaken the Paris central government by the division of power to major provinces during the French Revolution. In India, there is a three-tiered government structure with the Central government, state and union government, and panchayats and municipalities. An asymmetric federal system can be here with certain states getting limited autonomy.

The advantages of a federal system include diffusion of power, creating responsible state governments, managing the internal and external disputes, the involvement of the citizens, and spreading awareness about politics and also the demolition of single regulating power. Disadvantages include unequal distribution of political power, interference of states in critical policies as determined by the central government, and also internal conflicts within the states. Moreover, the positive aspects of federalism overshadow the disadvantages.

Short Essay on Federalism 150 Words in English

Short Essay on Federalism is usually given to classes 1, 2, 3, 4, 5, and 6.

Federalism means the coexistence of a central administrative authority and state or local administrative units in their respective areas. Federalism is an important part of a nation’s political structure by allowing the governing authorities to work separately.

Federalism has a direct influence on a country’s fiscal policy, the effectiveness of the government, and economic development. It also allows provision for innovative ideas, democratic views, and unification of unprecedented powers.

Federalism allows the states to have greater freedom and take individual decisions within their respective provinces. The Central government can concentrate more on national issues and international relations. The active participation of citizens results in greater awareness about their political and civil rights with a sense of national unity. Differential state power and internal issues often worsen the federation, but the merits of federalism are way more than the demerits.

10 Lines on Federalism in English

• Federalism has two sets of government, one at a regional level and the other at a national level.
• Federalism includes dual citizenship, which means the citizens are part of both the country and the state.
• Each level of government has particular sources of revenue for ensuring stability.
• The role of the constitution is very important, and there is no scope for arbitrary changes without the mutual consent of the central and state governments.
• The central and state governments have their jurisdiction.
• There is no interference of the states in the decisions of the central government.
• The states can function independently but are answerable to the central government.
• Federalism is solely based on democratic rules.
• Federalism unites various states and other governing units over a geographical area.
• Federalism involves the creation of new laws, regionalism, and economic development with disparities between different regions of a country.

FAQ’s on Federalism Essay

Question 1. What is the importance of federalism?

Answer:  Federalism includes the citizens’ opinions and views are taken into consideration and balance the internal relationships within the states, and acts as a buffer to external conflicts.

Question 2. How does federalism affect the state governments?

Answer:  The boon of federalism to the state and local governments is that they can function on their own, but they have to compromise as certain powers are given to the central authority, and it can interfere in the state government decisions.

Question 3.  What is the effect of federalism on the Indian economy?

Answer:  All the economic reforms and various economic policymaking developments take place due to the Indian Federal system.

Question 4. What is the effect of Covid-19 on the Indian federal system?

Answer:  The central government has implemented various new reforms in different domains of the Indian economy, although the global pandemic has been a severe threat to this federal system.

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• Introduction

Written constitution

Noncentralization, areal division of power, elements maintaining noncentralization, elements maintaining the federal principle.

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• Social Science LibreTexts - The Meanings of Federalism
• Princeton University - Encyclopedia Princetoniensis - Federalism and Federation
• Free Speech Center at Middle Tennessee State University - Federalism
• Salt Lake Community College - Attenuated Democracy - The Historical Development of Federalism
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federalism , mode of political organization that unites separate states or other polities within an overarching political system in a way that allows each to maintain its own integrity . Federal systems do this by requiring that basic policies be made and implemented through negotiation in some form, so that all the members can share in making and executing decisions. The political principles that animate federal systems emphasize the primacy of bargaining and negotiated coordination among several power centres; they stress the virtues of dispersed power centres as a means for safeguarding individual and local liberties.

The various political systems that call themselves federal differ in many ways. Certain characteristics and principles, however, are common to all truly federal systems.

First, the federal relationship must be established or confirmed through a perpetual covenant of union , usually embodied in a written constitution that outlines the terms by which power is divided or shared; the constitution can be altered only by extraordinary procedures. These constitutions are distinctive in being not simply compacts between rulers and ruled but involving the people, the general government, and the states constituting the federal union. The constituent states, moreover, often retain constitution-making rights of their own.

Second, the political system itself must reflect the constitution by actually diffusing power among a number of substantially self-sustaining centres. Such a diffusion of power may be termed noncentralization . Noncentralization is a way of ensuring in practice that the authority to participate in exercising political power cannot be taken away from the general or the state governments without common consent.

A third element of any federal system is what has been called in the United States territorial democracy . This has two faces: the use of areal divisions to ensure neutrality and equality in the representation of the various groups and interests in the polity and the use of such divisions to secure local autonomy and representation for diverse groups within the same civil society . Territorial neutrality has proved highly useful in societies that are changing, allowing for the representation of new interests in proportion to their strength simply by allowing their supporters to vote in relatively equal territorial units. At the same time, the accommodation of very diverse groups whose differences are fundamental rather than transient by giving them territorial power bases of their own has enhanced the ability of federal systems to function as vehicles of political integration while preserving democratic government. One example of this system may be seen in Canada , which includes a population of French descent, centred in the province of Quebec.

Elements maintaining union

Modern federal systems generally provide direct lines of communication between the citizenry and all the governments that serve them. The people may and usually do elect representatives to all the governments, and all of them may and usually do administer programs that directly serve the individual citizen.

The existence of those direct lines of communication is one of the features distinguishing federations from leagues or confederations . It is usually based on a sense of common nationality binding the constituent polities and people together. In some countries this sense of nationality has been inherited, as in Germany , while in the United States, Argentina , and Australia it had to be at least partly invented. Canada and Switzerland have had to evolve this sense in order to hold together strongly divergent nationality groups.

Geographic necessity has played a part in promoting the maintenance of union within federal systems. The Mississippi Valley in the United States, the Alps in Switzerland, the island character of the Australian continent, and the mountains and jungles surrounding Brazil have all been influences promoting unity; so have the pressures for Canadian union arising from that country’s situation on the border of the United States and the pressures upon the German states generated by their neighbours to the east and west. In this connection, the necessity for a common defense against common enemies has stimulated federal union in the first place and acted to maintain it.

The constituent polities in a federal system must be fairly equal in population and wealth or else balanced geographically or numerically in their inequalities. In the United States, each geographic section has included both great and small states. In Canada, the ethnic differences between the two largest and richest provinces have prevented them from combining against the others. Swiss federalism has been supported by the existence of groups of cantons of different sizes and religio-linguistic backgrounds. Similar distributions exist in every other successful federal system.

A major reason for the failure of federal systems has often been a lack of balance among the constituent polities. In the German federal empire of the late 19th century, Prussia was so dominant that the other states had little opportunity to provide national leadership or even a reasonably strong alternative to the policy of the king and government. During the Soviet era (1917–90/91), the existence of the Russian Soviet Federated Socialist Republic—occupying three-fourths of the area and containing three-fifths of the population—severely limited the possibility of authentic federal relationships in that country even if the communist system had not.

Successful federal systems have also been characterized by the permanence of their internal boundaries. Boundary changes may occur, but such changes are made only with the consent of the polities involved and are avoided except in extreme situations.

In a few very important cases, noncentralization is given support through the constitutionally guaranteed existence of different systems of law in the constituent polities. In the United States, each state’s legal system stems directly and to a certain extent uniquely from English (and, in one case, French) law, while federal law occupies only an interstitial position binding the systems of the 50 states together. The resulting mixture of laws keeps the administration of justice substantially noncentralized, even in federal courts. In Canada, the existence of common-law and civil-law systems side by side has contributed to French-Canadian cultural survival. Federal systems more often provide for modification of national legal codes by the subnational governments to meet special local needs, as in Switzerland.

The point has often been made that in a truly federal system the constituent polities must have substantial influence over the formal or informal constitutional -amending process. Since constitutional changes are often made without formal constitutional amendment , the position of the constituent polities must be such that serious changes in the political order can be made only by the decision of dispersed majorities that reflect the areal division of powers . Federal theorists have argued that this is important for popular government as well as for federalism.

Noncentralization is also strengthened by giving the constituent polities guaranteed representation in the national legislature and often by giving them a guaranteed role in the national political process. The latter is guaranteed in the written constitutions of the United States and Switzerland. In other systems, such as those of Canada and Latin America , the constituent polities have acquired certain powers of participation, and these have become part of the unwritten constitution.

Perhaps the most important single element in the maintenance of federal noncentralization is the existence of a noncentralized party system. Noncentralized parties initially develop out of the constitutional arrangements of the federal compact, but once they have come into existence they tend to be self-perpetuating and to function as decentralizing forces in their own right. The United States and Canada provide examples of the forms that a noncentralized party system may take. In the two-party system of the United States, the parties are actually coalitions of the state parties (which may in turn be dominated by specific local party organizations) and generally function as national units only for the quadrennial presidential elections or for purposes of organizing the national Congress.

In Canada, on the other hand, the parliamentary form of government, with its requirements of party responsibility, means that on the national plane considerably more party cohesiveness must be maintained simply in order to gain and hold power. There has been a fragmentation of the parties along regional or provincial lines. The party victorious in national elections is likely to be the one able to expand its provincial electoral bases temporarily to national proportions.

Federal nations with less-developed party systems frequently gain some of the same decentralizing effects through what has been called caudillismo —in which power is diffused among strong local leaders operating in the constituent polities. Caudillistic noncentralization has apparently existed also in Nigeria and Malaysia.

Several devices found in federal systems serve to maintain the federal principle itself. Two of these are of particular importance.

The maintenance of federalism requires that the central government and the constituent polities each have substantially complete governing institutions of their own, with the right to modify those institutions unilaterally within limits set by the compact. Both separate legislative and separate administrative institutions are necessary.

The contractual sharing of public responsibilities by all governments in the system appears to be a fundamental characteristic of federalism. Sharing, broadly conceived, includes common involvement in policy making, financing, and administration. Sharing may be formal or informal; in federal systems, it is usually contractual. The contract is used as a legal device to enable governments to engage in joint action while remaining independent entities. Even where there is no formal arrangement, the spirit of federalism tends to infuse a sense of contractual obligation.

Federal systems or systems strongly influenced by federal principles have been among the most stable and long-lasting of polities. But the successful operation of federal systems requires a particular kind of political environment , one that is conducive to popular government and has the requisite traditions of political cooperation and self-restraint. Beyond this, federal systems operate best in societies with sufficient homogeneity of fundamental interests to allow a great deal of latitude to local government and to permit reliance upon voluntary collaboration. The use of force to maintain domestic order is even more inimical to the successful maintenance of federal patterns of government than to other forms of popular government. Federal systems are most successful in societies that have the human resources to fill many public offices competently and the material resources to afford a measure of economic waste as part of the price of liberty.

The Federalist Papers

By alexander hamilton , james madison , john jay, the federalist papers summary and analysis of essay 51.

James Madison begins his famous federalist paper by explaining that the purpose of this essay is to help the readers understand how the structure of the proposed government makes liberty possible. Each branch should be, in Madison's opinion, mostly independent. To assure such independence, no one branch should have too much power in selecting members of the other two branches. If this principle were strictly followed, it would mean that the citizens should select the president, the legislators, and the judges. But the framers recognized certain practical difficulties in making every office elective. In particular, the judicial branch would suffer because the average person is not aware of the qualifications judges should possess. Judges should have great ability, but also be free of political pressures. Since federal judges are appointed for life, their thinking will not be influenced by the president who appoints them, nor the senators whose consent the president will seek.

The members of each branch should not be too dependent on the members of the other two branches in the determination of their salaries. The best security against a gradual concentration of power in any one branch is to provide constitutional safeguards that would make such concentration difficult. The constitutional rights of all must check one man's personal interests and ambitions. We may not like to admit that men abuse power, but the very need for government itself proves they do: "if men were angels, no government would be necessary." Unfortunately, all men are imperfect, the rulers and the ruled. Consequently, the great problem in framing a government is that the government must be able to control the people, but equally important, must be forced to control itself. The dependence of the government on the will of the people is undoubtedly the best control, but experience teaches that other controls are necessary.

Dividing power helps to check its growth in any one direction, but power cannot be divided absolutely equally. In the republican form of government, the legislative branch tends to be the most powerful. That is why the framers divided the Congress into two branches, the House of Representatives and the Senate, and provided for a different method of election in each branch. Further safeguards against legislative tyranny may be necessary.

In a representative democracy it is not only important to guard against the oppression of rulers, it is equally important to guard against the injustice which may be inflicted by certain citizens or groups. Majorities often threaten the rights of minorities. There are only two methods of avoiding evil. The first is to construct a powerful government, a "community will." Such a "will' is larger than, and independent of, the simple majority. This "solution" is dangerous because such a government might throw its power behind a group in society working against the public good. In our country, the authority to govern comes from the entire society. In addition, under the Constitution society is divided into many groups of people who hold different views and have different interests. This makes it very difficult for one group to dominate or threaten the minority groups.

Justice is the purpose of government and civil society. If government allows or encourages strong groups to combine together against the weak, liberty will be lost and anarchy will result. And the condition of anarchy tempts even strong individuals and groups to submit to any form of government, no matter how bad, which they hope will protect them as well as the weak.

Madison concludes that self-government flourishes in a large country containing many different groups. Some countries are too large for self-government, but the proposed plan modifies the federal principle enough to make self-government both possible and practical in the United States.

In this essay, Madison's thoughts on factionalism are delineated clearly. As we observed earlier, he assumed that conflicts of interests are inherent in human nature, and he recognized that, as a consequence, people fall into various groups. He wanted to avoid a situation in which any one group controlled the decisions of a society. Free elections and the majority principle protected the country from dictatorship, that is, the tyranny of a minority. However, he was equally concerned about the greater risk of tyranny of the majority. A central institutional issue for him was how to minimize this risk.

Madison's solution characteristically relied not only on formal institutions, which could be designed, but also on the particular sociological structure of American society, which he took as a fortunate starting point for the framers of the new constitution. The institutional component in his solution was checks and balances, so that there were multiple entry points into the government and multiple ways to offset the power that any one branch of the government might otherwise acquire over another. In this system, "the constant aim is to divide and arrange the several offices in such a manner as that each may be a check on each other."

These institutional arrangements were reinforced by the sociological fact that the Republic contained a multiplicity of interests that could, and did, offset one another: "While all authority in it will be derived from and dependent on the society, the society itself will be broken into so many parts, interests and classes of citizens that the rights of individuals, or of the minority, will be in little danger from interested combinations of the majority." It is good that there are many group interests; that they be numerous is less important than that they be impermanent and shifting alliances whose components vary with the specific policy issue.

Madison commenced the statement of his theory in Federalist 51 with an acknowledgement that the "have nots" in any society are extremely likely to attack the "haves." Like Hamilton, the Virginian believed class struggle to be inseparable from politics. "It is of great importance in a republic not only to guard against the oppression of its rulers," Madison writes, "but to guard one part of the society against the injustice of the other. Different interests necessarily exist in different classes of citizens. If a majority be united by a common interest the rights of the minority will be insecure."

Madison, it is clear, had emancipated himself from the sterile dualistic view of society that was so common in the eighteenth century and that so obsessed Hamilton. Madison was one of the pioneers of "pluralism" in political thought. Where Hamilton saw the corporate spirit of the several states as poisonous to the union, Madison was aware that the preservation of the state governments could serve the cause of both liberty and union. Finally, the vastness of the United States, a fact that Hamilton considered the prime excuse for autocracy, was recognized by Madison as the surest preservative of liberty. To assert after reading this passage that Alexander Hamilton wrote Federalist 51 is to imply, first, that he was a magician in mimicking Madison's very words and tone of vote, and second that he was the most disingenuous hypocrite that ever wrote on politics. No unprejudiced or informed historian would accept this latter charge against Hamilton.

It is interesting to note that the Federalist papers are unique, as shown in this paper, because of the extreme amount of thought that was put into the design of the Constitution, as shown in Madison's original thought process that were penned in 51. Many, if not most, changes in institutional design, occur as the reactions of shortsighted people to what they perceive as more-or-less short-range needs. This is one reason the Constitutional Convention was a remarkable event. The Founding Fathers set out deliberately to design the form of government that would be most likely to bring about the long-range goals that they envisaged for the Republic. What is most unusual about Madison, in contrast to the other delegates, is the degree to which he thought about the principles behind the institutions he preferred. Not only did he practice the art of what nowadays is deemed institutional design, but he developed, as well, the outlines of a theory of institutional design that culminated in this essay.

The Federalist Papers Questions and Answers

The Question and Answer section for The Federalist Papers is a great resource to ask questions, find answers, and discuss the novel.

how are conflictstoo often decided in unstable government? Whose rights are denied when this happens?

In a typical non-democratic government with political instability, the conflicts are often decided by the person highest in power, who abuse powers or who want to seize power. Rival parties fight each other to the detriment of the country.

How Madison viewed human nature?

Madison saw depravity in human nature, but he saw virtue as well. His view of human nature may have owed more to John Locke than to John Calvin. In any case, as Saul K. Padover asserted more than a half-century ago, Madison often appeared to steer...

How arguable and provable is the author of cato 4 claim

What specific claim are you referring to?

Study Guide for The Federalist Papers

The Federalist Papers study guide contains a biography of Alexander Hamilton, John Jay and James Madison, literature essays, a complete e-text, quiz questions, major themes, characters, and a full summary and analysis.

• About The Federalist Papers
• The Federalist Papers Summary
• The Federalist Papers Video
• Character List

Essays for The Federalist Papers

The Federalist Papers essays are academic essays for citation. These papers were written primarily by students and provide critical analysis of The Federalist Papers by Alexander Hamilton, John Jay and James Madison.

• A Close Reading of James Madison's The Federalist No. 51 and its Relevancy Within the Sphere of Modern Political Thought
• Lock, Hobbes, and the Federalist Papers
• Comparison of Federalist Paper 78 and Brutus XI
• The Paradox of the Republic: A Close Reading of Federalist 10
• Manipulation of Individual Citizen Motivations in the Federalist Papers

Lesson Plan for The Federalist Papers

• About the Author
• Study Objectives
• Common Core Standards
• Introduction to The Federalist Papers
• Relationship to Other Books
• Bringing in Technology
• Notes to the Teacher
• Related Links
• The Federalist Papers Bibliography

E-Text of The Federalist Papers

The Federalist Papers e-text contains the full text of The Federalist Papers by Alexander Hamilton, John Jay and James Madison.

• FEDERALIST. Nos. 1-5
• FEDERALIST. Nos. 6-10
• FEDERALIST. Nos. 11-15
• FEDERALIST. Nos. 16-20
• FEDERALIST. Nos. 21-25

Wikipedia Entries for The Federalist Papers

• Introduction
• Structure and content
• Judicial use
• Complete list

Reading: The Meanings of Federalism

Learning objectives.

After reading this section, you should be able to answer the following questions:

• How has the meaning of federalism changed over time?
• Why has the meaning of federalism changed over time?
• What are states’ rights and dual, cooperative, and competitive federalism?

The meaning of federalism has changed over time. During the first decades of the republic, many politicians held that states’ rights allowed states to disobey any national government that in their view exceeded its powers. Such a doctrine was largely discredited after the Civil War. Then dual federalism , a clear division of labor between national and state government, became the dominant doctrine. During the New Deal of the 1930s, cooperative federalism , whereby federal and state governments work together to solve problems, emerged and held sway until the 1960s. Since then, the situation is summarized by the term competitive federalism , whereby responsibilities are assigned based on whether the national government or the state is thought to be best able to handle the task.

States’ Rights

The ink had barely dried on the Constitution when disputes arose over federalism. Treasury Secretary Alexander Hamilton hoped to build a strong national economic system; Secretary of State Thomas Jefferson favored a limited national government. Hamiltonian and Jeffersonian factions in President George Washington’s cabinet led to the first political parties: respectively, the Federalists, who favored national supremacy, and the Republicans, who supported states’ rights.

Compact Theory

In 1798, Federalists passed the Alien and Sedition Acts, outlawing malicious criticism of the government and authorizing the president to deport enemy aliens. In response, the Republican Jefferson drafted a resolution passed by Kentucky’s legislature, the first states’ rights manifesto. It set forth a compact theory, claiming that states had voluntarily entered into a “compact” to ratify the Constitution. Consequently, each state could engage in “nullification” and “judge for itself” if an act was constitutional and refuse to enforce it. [1] However, Jefferson shelved states’ rights when, as president, he directed the national government to purchase the enormous Louisiana Territory from France in 1803.

Links: Alien and Sedition Acts; Jefferson’s Role

Read more about the Alien and Sedition Acts online .

Read more about Jefferson’s role online .

Slavery and the Crisis of Federalism

After the Revolutionary War, slavery waned in the North, where slaves were domestic servants or lone farmhands. In the South, labor-intensive crops on plantations were the basis of Southern prosperity, which relied heavily on slaves. [2]

In 1850, Congress faced the prospect of new states carved from land captured in the Mexican War and debated whether they would be slave or free states. In a compromise, Congress admitted California as a free state but directed the national government to capture and return escaped slaves, even in free states. Officials in Northern states decried such an exertion of national power favoring the South. They passed state laws outlining rights for accused fugitive slaves and forbidding state officials from capturing fugitives. [3] The Underground Railroad transporting escaped slaves northward grew. The saga of hunted fugitives was at the heart of Harriet Beecher Stowe’s 1852 novel Uncle Tom’s Cabin , which sold more copies proportional to the American population than any book before or since.

Lithograph from Uncle Tom’s Cabin. The plight of fugitive slaves, vividly portrayed in the mega best seller of the 1850s, Uncle Tom’s Cabin, created a crisis in federalism that led directly to the Civil War.

In 1857, the Supreme Court stepped into the fray. Dred Scott, the slave of a deceased Missouri army surgeon, sued for freedom, noting he had accompanied his master for extended stays in a free state and a free territory. [4] The justices dismissed Scott’s claim. They stated that blacks, excluded from the Constitution, could never be U.S. citizens and could not sue in federal court. They added that any national restriction on slavery in territories violated the Fifth Amendment, which bars the government from taking property without due process of law. To many Northerners, the Dred Scott decision raised doubts about whether  any state could effectively ban slavery. In December 1860, a convention in South Carolina repealed the state’s ratification of the Constitution and dissolved its union with the other states. Ten other states followed suit. The eleven formed the Confederate States of America.

Links: The Underground Railroad and the Dred Scott Case

Learn more about the Underground Railroad online .

Learn more about the Dred Scott case from the Library of Congress .

Enduring Image: The Confederate Battle Flag

The American flag is an enduring image of the United States’ national unity. The Civil War battle flag of the Confederate States of America is also an enduring image, but of states’ rights, of opposition to a national government, and of support for slavery. The blue cross studded with eleven stars for the states of the Confederacy was not its official flag. Soldiers hastily pressed it into battle to avoid confusion between the Union’s Stars and Stripes and the Confederacy’s Stars and Bars. After the South’s defeat, the battle flag, often lowered for mourning, was mainly a memento of gallant human loss. [5]

The flag’s meaning was transformed in the 1940s as the civil rights movement made gains against segregation in the South. One after another Southern state flew the flag above its capitol or defiantly redesigned the state flag to incorporate it. Over the last sixty years, a myriad of meanings arousing deep emotions have become attached to the flag: states’ rights; Southern regional pride; a general defiance of big government; nostalgia for a bygone era; racist support of segregation; or “equal rights for whites.” [6]

The Confederate flag

The battle flag appeals to politicians seeking resonant images. But its multiple meanings can backfire. In 2003, former Vermont governor Howard Dean, a candidate for the Democratic presidential nomination, addressed the Democratic National Committee and said, “White folks in the South who drive pickup trucks with Confederate flag decals on the back ought to be voting with us, and not them [Republicans], because their kids don’t have health insurance either, and their kids need better schools too.” Dean received a rousing ovation, so he probably thought little of it when he told the Des Moines Register , “I still want to be the candidate for guys with Confederate flags in their pickup trucks.” [7] Dean, the Democratic front runner, was condemned by his rivals who questioned his patriotism, judgment, and racial sensitivity. Dean apologized for his remark. [8]

The South’s defeat in the Civil War discredited compact theory and nullification. Since then, state officials’ efforts to defy national orders have been futile. In 1963, Governor George Wallace stood in the doorway of the University of Alabama to resist a court order to desegregate the all-white school. Eventually, he had no choice but to accede to federal marshals. In 1994, Pennsylvania governor Robert Casey, a pro-life Democrat, decreed he would not allow state officials to enforce a national order that state-run Medicaid programs pay for abortions in cases of rape and incest. He lost in court. [9]

Dual Federalism

After the Civil War, the justices of the Supreme Court wrote, “The Constitution, in all its provisions, looks to an indestructible Union, composed of indestructible States.” [10] They endorsed dual federalism, a doctrine whereby national and state governments have clearly demarcated domains of power. The national government is supreme, but only in the areas where the Constitution authorizes it to act.

The basis for dual federalism was a series of Supreme Court decisions early in the nineteenth century. The key decision was McCulloch v. Maryland (1819). The Court struck down a Maryland state tax on the Bank of the United States chartered by Congress. Chief Justice Marshall conceded that the Constitution gave Congress no explicit power to charter a national bank, [11] but concluded that the Constitution’s necessary-and-proper clause enabled Congress and the national government to do whatever it deemed “convenient or useful” to exercise its powers. As for Maryland’s tax, he wrote, “the power to tax involves the power to destroy.” Therefore, when a state’s laws interfere with the national government’s operation, the latter takes precedence. From the 1780s to the Great Depression of the 1930s, the size and reach of the national government were relatively limited. As late as 1932, local government raised and spent more than the national government or the states.

On two subjects, however, the national government increased its power in relationship to the states and local governments: sin and economic regulation.

Link:  McCulloch v. Maryland

Read more about McCulloch v. Maryland (1819) online .

The Politics of Sin

National powers were expanded when Congress targeted obscenity, prostitution, and alcohol. [12] In 1872, reformers led by Anthony Comstock persuaded Congress to pass laws blocking obscene material from being carried in the U.S. mail. Comstock had a broad notion of sinful media: all writings about sex, birth control, abortion, and childbearing, plus tabloid newspapers that allegedly corrupted innocent youth.

As a result of these laws, the national government gained the power to exclude material from the mail even if it was legal in individual states.

The power of the national government also increased when prostitution became a focus of national policy. A 1910 exposé in McClure’s magazine roused President William Howard Taft to warn Congress about prostitution rings operating across state lines. The ensuing media frenzy depicted young white girls torn from rural homes and degraded by an urban “white slave trade.” Using the commerce clause, Congress passed the Mann Act to prohibit the transportation “in interstate commerce…of any woman or girl for the purpose of prostitution or debauchery, or for any other immoral purpose.” [13] The bill turned enforcement over to a tiny agency concerned with antitrust and postal violations, the Bureau of Investigations. The Bureau aggressively investigated thousands of allegations of “immoral purpose,” including unmarried couples crossing state lines to wed and interracial married couples.

The crusade to outlaw alcohol provided the most lasting expansion of national power. Reformers persuaded Congress in 1917 to bar importation of alcohol into dry states, and, in 1919, to amend the Constitution to allow for the nationwide prohibition of alcohol. Pervasive attempts to evade the law boosted organized crime, a rationale for the Bureau of Investigations to bloom into the Federal Bureau of Investigation (FBI), the equivalent of a national police force, in the 1920s.

Prohibition was repealed in 1933. But the FBI under J. Edgar Hoover, its director from the 1920s to the 1970s, continued to call attention through news and entertainment media to the scourge of organized crime that justified its growth, political independence, and Hoover’s power. The FBI supervised film depictions of the lives of criminals like John Dillinger and long-running radio and television shows like The FBI . The heroic image of federal law enforcement would not be challenged until the 1960s when the classic film Bonnie and Clyde romanticized the tale of two small-time criminals into a saga of rebellious outsiders crushed by the ominous rise of authority across state lines.

Economic Regulation

Other national reforms in the late nineteenth century that increased the power of the national government were generated by reactions to industrialization, immigration, and urban growth. Crusading journalists decried the power of big business. Upton Sinclair’s 1906 novel The Jungle  exposed miserable, unsafe working conditions in America’s factories. These reformers feared that states lacked the power or were reluctant to regulate railroads, inspect meat, or guarantee food and drug safety. They prompted Congress to use its powers under the commerce clause for economic regulation, starting with the Interstate Commerce Act in 1887 to regulate railroads and the Sherman Antitrust Act in 1890 to outlaw monopolies.

The Supreme Court, defending dual federalism, limited such regulation. It held in 1895 that the national government could only regulate matters directly affecting interstate commerce. [14] In 1918, it ruled that Congress could not use the commerce clause to deal with local matters like conditions of work. The national government could regulate interstate commerce of harmful products such as lottery tickets or impure food. [15] A similar logic prevented the U.S. government from using taxation powers to the same end. [16]

Cooperative Federalism

The massive economic crises of the Great Depression tolled the death knell for dual federalism. In its place, cooperative federalism emerged. Instead of a relatively clear separation of policy domains, national, state, and local governments would work together to try to respond to a wide range of problems.

The New Deal and the End of Dual Federalism

Elected in 1932, Democratic president Franklin Delano Roosevelt (FDR) sought to implement a “New Deal” for Americans amid staggering unemployment. He argued that the national government could restore the economy more effectively than states or localities. He persuaded Congress to enact sweeping legislation. New Deal programs included boards enforcing wage and price guarantees; programs to construct buildings and bridges, develop national parks, and create artworks; and payments to farmers to reduce acreage of crops and stabilize prices.

Dorothea Lange photograph, Gordonton, North Carolina, 1939. The 1930s New Deal programs included commissioning photographers to document social conditions during the Great Depression. The resultant photographs are both invaluable historical documents and lasting works of art.

By 1939, national government expenditures equaled state and local expenditures combined. [17] FDR explained his programs to nationwide audiences in “fireside chats” on the relatively young medium of radio. His policies were highly popular, and he was reelected by a landslide in 1936. The Supreme Court, after rejecting several New Deal measures, eventually upheld national authority over such once-forbidden terrain as labor-management relations, minimum wages, and subsidies to farmers. [18] The Court thereby sealed the fate of dual federalism.

Links: The New Deal and Fireside Chats

Learn more about the New Deal online .

Read the Fireside Chats online .

Grants-in-Aid

Cooperative federalism’s central mechanisms were grants-in-aid : the national government passes funds to the states to administer programs. Starting in the 1940s and 1950s, national grants were awarded for infrastructure (airport construction, interstate highways), health (mental health, cancer control, hospital construction), and economic enhancement (agricultural marketing services, fish restoration). [19]

Grants-in-aid were cooperative in three ways. First, they funded policies that states already oversaw. Second, categorical grants required states to spend the funds for purposes specified by Congress but gave them leeway on how to do so. Third, states’ and localities’ core functions of education and law enforcement had little national government supervision. [20]

Competitive Federalism

During the 1960s, the national government moved increasingly into areas once reserved to the states. As a result, the essence of federalism today is competition rather than cooperation. [21]

Judicial Nationalizing

Cooperative federalism was weakened when a series of Supreme Court decisions, starting in the 1950s, caused states to face much closer supervision by national authorities. As you’ll see, the Court extended requirements of the Bill of Rights and of “equal protection of the law” to the states.

The Great Society

In 1963, President Lyndon Johnson proposed extending the New Deal policies of his hero, FDR. Seeking a “Great Society” and declaring a “War on Poverty,” Johnson inspired Congress to enact massive new programs funded by the national government. Over two hundred new grants programs were enacted during Johnson’s five years in office. They included a Jobs Corps and Head Start, which provided preschool education for poor children.

The Great Society undermined cooperative federalism. The new national policies to help the needy dealt with problems that states and localities had been unable or reluctant to address. Many of them bypassed states to go straight to local governments and nonprofit organizations. [22]

Link: The Great Society

Read more about The Great Society .

Obstacles and Opportunities

In competitive federalism, national, state, and local levels clash, even battle with each other. [23] Overlapping powers and responsibilities create friction, which is compounded by politicians’ desires to get in the news and claim credit for programs responding to public problems.

Competition between levels of federalism is a recurring feature of films and television programs. For instance, in the eternal television drama Law and Order and its offshoots, conflicts between local, state, and national law enforcement generate narrative tension and drama. This media frame does not consistently favor one side or the other. Sometimes, as in the film The Fugitive or stories about civil rights like Mississippi Burning , national law enforcement agencies take over from corrupt local authorities. Elsewhere, as in the action film Die Hard , national law enforcement is less competent than local or state police.

Under competitive federalism, funds go from national to state and local governments with many conditions—most notably, directives known as mandates . [24] State and local governments want national funds but resent conditions. They especially dislike “unfunded mandates,” according to which the national government directs them what to do but gives them no funds to do it.

After the Republicans gained control of Congress in the 1994 elections, they passed a rule to bar unfunded mandates. If a member objects to an unfunded mandate, a majority must vote to waive the rule in order to pass it. This reform has had little impact: negative news attention to unfunded mandates is easily displaced by dramatic, personalized issues that cry out for action. For example, in 1996, the story of Megan Kanka, a young New Jersey girl killed by a released sex offender living in her neighborhood, gained huge news attention. The same Congress that outlawed unfunded mandates passed “Megan’s Law”—including an unfunded mandate ordering state and local law enforcement officers to compile lists of sex offenders and send them to a registry run by the national government.

Key Takeaways

Federalism in the United States has changed over time from clear divisions of powers between national, state, and local governments in the early years of the republic to greater intermingling and cooperation as well as conflict and competition today. Causes of these changes include political actions, court decisions, responses to economic problems (e.g., depression), and social concerns (e.g., sin).

• Forrest McDonald, States’ Rights and the Union: Imperium in Imperio, 1776–1876 (Lawrence: University Press of Kansas, 2000), 38–43. ↵
• This section draws on James M. McPherson, Battle Cry of Freedom: The Civil War Era (New York: Oxford University Press, 1988). ↵
• Thomas D. Morris, Free Men All: The Personal Liberty Laws of the North, 1780–1861 (Baltimore, MD: Johns Hopkins University Press, 1974). ↵
• An encyclopedic account of this case is Don E. Fehrenbacher, The Dred Scott Case: Its Significance in American Law and Politics (New York: Oxford University Press, 1978). ↵
• See especially Robert E. Bonner, Colors and Blood: Flag Passions of the Confederate South (Princeton, NJ: Princeton University Press, 2002). ↵
• For overviews of these meanings see Tony Horwitz, Confederates in the Attic: Dispatches from the Unfinished Civil War (New York: Random House, 1998) and J. Michael Martinez, William D. Richardson, and Ron McNinch-Su, eds., Confederate Symbols in the Contemporary South (Gainesville: University of Florida Press, 2000). ↵
• All quotes come from “ Dems Battle over Confederate Flag ,” CNN, November 2, 2003. ↵
• “ Dean: ‘I Apologize’ for Flag Remark ,” CNN, November 7, 2003. ↵
• David L. Shapiro, Federalism: A Dialogue (Evanston, IL: Northwestern University Press, 1995), 98 n. 139. ↵
• Texas v. White , 7 Wall. 700 (1869). ↵
• McCulloch v. Maryland , 4 Wheat. 316 (1819). ↵
• This section draws on James A. Morone, Hellfire Nation: The Politics of Sin in American History (New Haven, CT: Yale University Press, 2003), chaps. 8–11. ↵
• Quoted in James A. Morone, Hellfire Nation: The Politics of Sin in American History (New Haven, CT: Yale University Press, 2003), 266. ↵
• United States v. E. C. Knight , 156 US 1 (1895). ↵
• Hammer v. Dagenhart , 247 US 251 (1918). ↵
• Bailey v. Drexel Furniture Company , 259 US 20 (1922). ↵
• Thomas Anton, American Federalism & Public Policy: How the System Works (Philadelphia, PA: Temple University Press, 1988), 41. ↵
• Respectively, National Labor Relations Board v. Jones & Laughlin Steel , 301 US 1 (1937); United States v. Darby , 312 US 100 (1941); Wickard v. Filburn , 317 US 111 (1942). ↵
• David B. Walker, The Rebirth of Federalism: Slouching toward Washington (Washington, DC: CQ Press, 1999), 99. ↵
• Martha Derthick, Keeping the Compound Republic: Essays on American Federalism (Washington, DC: Brookings, 2001), 17. ↵
• Paul E. Peterson, Barry George Rabe, and Kenneth K. Wong, When Federalism Works (Washington, DC: Brookings, 1986), especially chap. 5; Martha Derthick, Keeping the Compound Republic: Essays on American Federalism (Washington, DC: Brookings, 2001), chap. 10. ↵
• David B. Walker, The Rebirth of Federalism: Slouching toward Washington (Washington, DC: CQ Press, 1999), 123–25. ↵
• The term “competitive federalism” is developed in Thomas R. Dye, American Federalism: Competition among Governments (Lexington, MA: Lexington Books, 1990). ↵
• This definition is drawn from Michael Fix and Daphne Kenyon, eds., Coping with Mandates: What Are the Alternatives? (Washington, DC: Urban Institute Press, 1988), 3–4. ↵
• Uncle Tom's Cabin. Authored by : moosevlt. Located at : https://www.flickr.com/photos/48734803@N00/252322873/ . License : CC BY: Attribution
• Confederate Flag. Provided by : Naval History and Heritage Command. Located at : https://commons.wikimedia.org/wiki/File:2011-95-1_Confederate_Second_National_Flag_(5669542154).jpg . License : CC BY: Attribution
• 21st Century American Government. Authored by : Anonymous. Provided by : Lardbucket. Located at : http://2012books.lardbucket.org/books/21st-century-american-government-and-politics/s07-02-the-meanings-of-federalism.html . License : CC BY-NC-SA: Attribution-NonCommercial-ShareAlike
• Dorothy Lange photograph. Provided by : Library of Congress. Located at : https://commons.wikimedia.org/wiki/File:Dorothea_Lange,_Country_store_on_dirt_road,_Gordonton,_North_Carolina,_1939.jpg . License : Public Domain: No Known Copyright

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Course: US history   >   Unit 3

• The Articles of Confederation
• What was the Articles of Confederation?
• Shays's Rebellion
• The Constitutional Convention
• The US Constitution

The Federalist Papers

• The Bill of Rights
• Social consequences of revolutionary ideals
• The presidency of George Washington
• Why was George Washington the first president?
• The presidency of John Adams
• Regional attitudes about slavery, 1754-1800
• Continuity and change in American society, 1754-1800
• Creating a nation

• The Federalist Papers was a collection of essays written by John Jay, James Madison, and Alexander Hamilton in 1788.
• The essays urged the ratification of the United States Constitution, which had been debated and drafted at the Constitutional Convention in Philadelphia in 1787.
• The Federalist Papers is considered one of the most significant American contributions to the field of political philosophy and theory and is still widely considered to be the most authoritative source for determining the original intent of the framers of the US Constitution.

The Articles of Confederation and Constitutional Convention

• In Federalist No. 10 , Madison reflects on how to prevent rule by majority faction and advocates the expansion of the United States into a large, commercial republic.
• In Federalist No. 39 and Federalist 51 , Madison seeks to “lay a due foundation for that separate and distinct exercise of the different powers of government, which to a certain extent is admitted on all hands to be essential to the preservation of liberty,” emphasizing the need for checks and balances through the separation of powers into three branches of the federal government and the division of powers between the federal government and the states. 4 ‍  
• In Federalist No. 84 , Hamilton advances the case against the Bill of Rights, expressing the fear that explicitly enumerated rights could too easily be construed as comprising the only rights to which American citizens were entitled.

What do you think?

• For more on Shays’s Rebellion, see Leonard L. Richards, Shays’s Rebellion: The American Revolution’s Final Battle (Philadelphia: University of Pennsylvania Press, 2002).
• Bernard Bailyn, ed. The Debate on the Constitution: Federalist and Anti-Federalist Speeches, Articles, and Letters During the Struggle over Ratification; Part One, September 1787 – February 1788 (New York: Penguin Books, 1993).
• See Federalist No. 1 .
• See Federalist No. 51 .
• For more, see Michael Meyerson, Liberty’s Blueprint: How Madison and Hamilton Wrote the Federalist Papers, Defined the Constitution, and Made Democracy Safe for the World (New York: Basic Books, 2008).

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3.6: Advantages and Disadvantages of Federalism

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Learning Objectives

By the end of this section, you will be able to:

• Discuss the advantages of federalism
• Explain the disadvantages of federalism

The federal design of our Constitution has had a profound effect on U.S. politics. Several positive and negative attributes of federalism have manifested themselves in the U.S. political system.

The Benefits of Federalism

Among the merits of federalism are that it promotes policy innovation and political participation and accommodates diversity of opinion. On the subject of policy innovation, Supreme Court Justice Louis Brandeis observed in 1932 that “a single courageous state may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.” 72 What Brandeis meant was that states could harness their constitutional authority to engage in policy innovations that might eventually be diffused to other states and at the national level. For example, a number of New Deal breakthroughs, such as child labor laws, were inspired by state policies. Prior to the passage of the Nineteenth Amendment, several states had already granted women the right to vote. California has led the way in establishing standards for fuel emissions and other environmental policies (Figure 3.18). Recently, the health insurance exchanges run by Connecticut, Kentucky, Rhode Island, and Washington have served as models for other states seeking to improve the performance of their exchanges. 73

Another advantage of federalism is that because our federal system creates two levels of government with the capacity to take action, failure to attain a desired policy goal at one level can be offset by successfully securing the support of elected representatives at another level. Thus, individuals, groups, and social movements are encouraged to actively participate and help shape public policy.

Get Connected

Federalism and political office.

Thinking of running for elected office? Well, you have several options. As Table 3.1 shows, there are a total of 510,682 elected offices at the federal, state, and local levels. Elected representatives in municipal and township governments account for a little more than half the total number of elected officials in the United States. Political careers rarely start at the national level. In fact, a very small share of politicians at the subnational level transition to the national stage as representatives, senators, vice presidents, or presidents.

If you are interested in serving the public as an elected official, there are more opportunities to do so at the local and state levels than at the national level. As an added incentive for setting your sights at the subnational stage, consider the following. Whereas only 35 percent of U.S. adults trusted Congress in 2018, according to Gallup, about 63 percent trusted their state governments and 72 percent had confidence in their local governments. 76 , 77

If you ran for public office, what problems would you most want to solve? What level of government would best enable you to solve them, and why?

The system of checks and balances in our political system often prevents the federal government from imposing uniform policies across the country. As a result, states and local communities have the latitude to address policy issues based on the specific needs and interests of their citizens. The diversity of public viewpoints across states is manifested by differences in the way states handle access to abortion, distribution of alcohol, gun control, and social welfare benefits, for example.

The Drawbacks of Federalism

Federalism also comes with drawbacks. Chief among them are economic disparities across states, race-to-the-bottom dynamics (i.e., states compete to attract business by lowering taxes and regulations), and the difficulty of taking action on issues of national importance.

Stark economic differences across states have a profound effect on the well-being of citizens. For example, in 2017, Maryland had the highest median household income ($80,776), while West Virginia had the lowest ($43,469). 78 There are also huge disparities in school funding across states. In 2016, New York spent $22,366 per student for elementary and secondary education, while Utah spent $6,953. 79 Furthermore, health-care access, costs, and quality vary greatly across states. 80 Proponents of social justice contend that federalism has tended to obstruct national efforts to effectively even out these disparities. When national policy-making is stymied, and policy advocates move to the state level, it takes fifty-one different advocacy efforts to bring about change, compared to one effort were the national government to take the lead.

Link to Learning

The National Education Association discusses the problem of inequality in the educational system of the United States. Visit the Racial & Social Justice page of the NEA website to see how NEA EdJustice is advocating for change in this area.

The economic strategy of using race-to-the-bottom tactics in order to compete with other states in attracting new business growth also carries a social cost. For example, workers’ safety and pay can suffer as workplace regulations are lifted, and the reduction in payroll taxes for employers has led a number of states to end up with underfunded unemployment insurance programs. 81 As of March 2021, twelve states have also opted not to expand Medicaid, as encouraged by the Patient Protection and Affordable Care Act in 2010, for fear it will raise state public spending and increase employers’ cost of employee benefits, despite provisions that the federal government will pick up nearly all cost of the expansion. 82 , 83 More than half of these states are in the South.

The federal design of our Constitution and the system of checks and balances has jeopardized or outright blocked federal responses to important national issues. President Roosevelt’s efforts to combat the scourge of the Great Depression were initially struck down by the Supreme Court. More recently, President Obama’s effort to make health insurance accessible to more Americans under the Affordable Care Act immediately ran into legal challenges 84 from some states, but it has been supported by the Supreme Court so far. However, the federal government’s ability to defend the voting rights of citizens suffered a major setback when the Supreme Court in 2013 struck down a key provision of the Voting Rights Act of 1965. 85 No longer are the nine states with histories of racial discrimination in their voting processes required to submit plans for changes to the federal government for approval. After a tumultuous 2020 election, many states in 2021 advanced legislation to make voting rules and processes more rigorous, a move many said was an effort to limit voting access. For example, elected leaders in Georgia passed a law making voter ID requirements much stricter and also significantly limited options to vote outside of Election Day itself. 86

3.2 The Evolution of American Federalism

Learning objectives.

By the end of this section, you will be able to:

• Describe how federalism has evolved in the United States
• Compare different conceptions of federalism

The Constitution sketches a federal framework that aims to balance the forces of decentralized and centralized governance in general terms; it does not flesh out standard operating procedures that say precisely how the states and federal governments are to handle all policy contingencies imaginable. Therefore, officials at the state and national levels have had some room to maneuver as they operate within the Constitution’s federal design. This has led to changes in the configuration of federalism over time, changes corresponding to different historical phases that capture distinct balances between state and federal authority.

THE STRUGGLE BETWEEN NATIONAL POWER AND STATE POWER

As George Washington’s secretary of the treasury from 1789 to 1795, Alexander Hamilton championed legislative efforts to create a publicly chartered bank. For Hamilton, the establishment of the Bank of the United States was fully within Congress’s authority, and he hoped the bank would foster economic development, print and circulate paper money, and provide loans to the government. Although Thomas Jefferson , Washington’s secretary of state, staunchly opposed Hamilton’s plan on the constitutional grounds that the national government had no authority to create such an instrument, Hamilton managed to convince the reluctant president to sign the legislation. 20

When the bank’s charter expired in 1811, Jeffersonian Democratic-Republicans prevailed in blocking its renewal. However, the fiscal hardships that plagued the government during the War of 1812 , coupled with the fragility of the country’s financial system, convinced Congress and then-president James Madison to create the Second Bank of the United States in 1816. Many states rejected the Second Bank, arguing that the national government was infringing upon the states’ constitutional jurisdiction.

A political showdown between Maryland and the national government emerged when James McCulloch, an agent for the Baltimore branch of the Second Bank, refused to pay a tax that Maryland had imposed on all out-of-state chartered banks. The standoff raised two constitutional questions: Did Congress have the authority to charter a national bank? Were states allowed to tax federal property? In McCulloch v. Maryland , Chief Justice John Marshall ( Figure 3.8 ) argued that Congress could create a national bank even though the Constitution did not expressly authorize it. 21 Under the necessary and proper clause of Article I , Section 8, the Supreme Court asserted that Congress could establish “all means which are appropriate” to fulfill “the legitimate ends” of the Constitution. In other words, the bank was an appropriate instrument that enabled the national government to carry out several of its enumerated powers, such as regulating interstate commerce, collecting taxes, and borrowing money.

This ruling established the doctrine of implied powers, granting Congress a vast source of discretionary power to achieve its constitutional responsibilities. The Supreme Court also sided with the federal government on the issue of whether states could tax federal property. Under the supremacy clause of Article VI , legitimate national laws trump conflicting state laws. As the court observed, “the government of the Union, though limited in its powers, is supreme within its sphere of action and its laws, when made in pursuance of the constitution, form the supreme law of the land.” Maryland’s action violated national supremacy because “the power to tax is the power to destroy.” This second ruling established the principle of national supremacy, which prohibits states from meddling in the lawful activities of the national government.

Defining the scope of national power was the subject of another landmark Supreme Court decision in 1824. In Gibbons v. Ogden , the court had to interpret the commerce clause of Article I , Section 8; specifically, it had to determine whether the federal government had the sole authority to regulate the licensing of steamboats operating between New York and New Jersey. 22 Aaron Ogden, who had obtained an exclusive license from New York State to operate steamboat ferries between New York City and New Jersey, sued Thomas Gibbons, who was operating ferries along the same route under a coasting license issued by the federal government. Gibbons lost in New York state courts and appealed. Chief Justice Marshall delivered a two-part ruling in favor of Gibbons that strengthened the power of the national government. First, interstate commerce was interpreted broadly to mean “commercial intercourse” among states, thus allowing Congress to regulate navigation. Second, because the federal Licensing Act of 1793, which regulated coastal commerce, was a constitutional exercise of Congress’s authority under the commerce clause, federal law trumped the New York State license-monopoly law that had granted Ogden an exclusive steamboat operating license. As Marshall pointed out, “the acts of New York must yield to the law of Congress.” 23

Various states railed against the nationalization of power that had been going on since the late 1700s. When President John Adams signed the Sedition Act in 1798, which made it a crime to speak openly against the government, the Kentucky and Virginia legislatures passed resolutions declaring the act null on the grounds that they retained the discretion to follow national laws. In effect, these resolutions articulated the legal reasoning underpinning the doctrine of nullification —that states had the right to reject national laws they deemed unconstitutional. 24

A nullification crisis emerged in the 1830s over President Andrew Jackson’s tariff acts of 1828 and 1832. Led by John Calhoun , President Jackson’s vice president, nullifiers argued that high tariffs on imported goods benefited northern manufacturing interests while disadvantaging economies in the South. South Carolina passed an Ordinance of Nullification declaring both tariff acts null and void and threatened to leave the Union. The federal government responded by enacting the Force Bill in 1833, authorizing President Jackson to use military force against states that challenged federal tariff laws. The prospect of military action coupled with the passage of the Compromise Tariff Act of 1833 (which lowered tariffs over time) led South Carolina to back off, ending the nullification crisis.

The ultimate showdown between national and state authority came during the Civil War . Prior to the conflict, in Dred Scott v. Sandford , the Supreme Court ruled that the national government lacked the authority to ban slavery in the territories. 25 But the election of President Abraham Lincoln in 1860 led eleven southern states to secede from the United States because they believed the new president would challenge the institution of slavery. What was initially a conflict to preserve the Union became a conflict to end slavery when Lincoln issued the Emancipation Proclamation in 1863, freeing all enslaved people in the rebellious states. The defeat of the South had a huge impact on the balance of power between the states and the national government in two important ways. First, the Union victory put an end to the right of states to secede and to challenge legitimate national laws. Second, Congress imposed several conditions for readmitting former Confederate states into the Union; among them was ratification of the Fourteenth and Fifteenth Amendment s. In sum, after the Civil War the power balance shifted toward the national government, a movement that had begun several decades before with McCulloch v. Maryland (1819) and Gibbons v. Ogden (1824).

The period between 1819 and the 1860s demonstrated that the national government sought to establish its role within the newly created federal design, which in turn often provoked the states to resist as they sought to protect their interests. With the exception of the Civil War, the Supreme Court settled the power struggles between the states and national government. From a historical perspective, the national supremacy principle introduced during this period did not so much narrow the states’ scope of constitutional authority as restrict their encroachment on national powers. 26

DUAL FEDERALISM

The late 1870s ushered in a new phase in the evolution of U.S. federalism. Under dual federalism , the states and national government exercise exclusive authority in distinctly delineated spheres of jurisdiction. Like the layers of a cake, the levels of government do not blend with one another but rather are clearly defined. Two factors contributed to the emergence of this conception of federalism. First, several Supreme Court rulings blocked attempts by both state and federal governments to step outside their jurisdictional boundaries. Second, the prevailing economic philosophy at the time loathed government interference in the process of industrial development.

Industrialization changed the socioeconomic landscape of the United States. One of its adverse effects was the concentration of market power. Because there was no national regulatory supervision to ensure fairness in market practices, collusive behavior among powerful firms emerged in several industries. 27 To curtail widespread anticompetitive practices in the railroad industry, Congress passed the Interstate Commerce Act in 1887, which created the Interstate Commerce Commission. Three years later, national regulatory capacity was broadened by the Sherman Antitrust Act of 1890, which made it illegal to monopolize or attempt to monopolize and conspire in restraining commerce ( Figure 3.9 ). In the early stages of industrial capitalism, federal regulations were focused for the most part on promoting market competition rather than on addressing the social dislocations resulting from market operations, something the government began to tackle in the 1930s. 28

The new federal regulatory regime was dealt a legal blow early in its existence. In 1895, in United States v. E. C. Knight , the Supreme Court ruled that the national government lacked the authority to regulate manufacturing. 29 The case came about when the government, using its regulatory power under the Sherman Act, attempted to override American Sugar’s purchase of four sugar refineries, which would give the company a commanding share of the industry. Distinguishing between commerce among states and the production of goods, the court argued that the national government’s regulatory authority applied only to commercial activities. If manufacturing activities fell within the purview of the commerce clause of the Constitution, then “comparatively little of business operations would be left for state control,” the court argued.

In the late 1800s, some states attempted to regulate working conditions. For example, New York State passed the Bakeshop Act in 1897, which prohibited bakery employees from working more than sixty hours in a week. In Lochner v. New York , the Supreme Court ruled this state regulation that capped work hours unconstitutional, on the grounds that it violated the due process clause of the Fourteenth Amendment. 30 In other words, the right to sell and buy labor is a “liberty of the individual” safeguarded by the Constitution, the court asserted. The federal government also took up the issue of working conditions, but that case resulted in the same outcome as in the Lochner case. 31

COOPERATIVE FEDERALISM

The Great Depression of the 1930s brought economic hardships the nation had never witnessed before ( Figure 3.10 ). Between 1929 and 1933, the national unemployment rate reached 25 percent, industrial output dropped by half, stock market assets lost more than half their value, thousands of banks went out of business, and the gross domestic product shrunk by one-quarter. 32 Given the magnitude of the economic depression, there was pressure on the national government to coordinate a robust national response along with the states.

Cooperative federalism was born of necessity and lasted well into the twentieth century as the national and state governments each found it beneficial. Under this model, both levels of government coordinated their actions to solve national problems, such as the Great Depression and the civil rights struggle of the following decades. In contrast to dual federalism, it erodes the jurisdictional boundaries between the states and national government, leading to a blending of layers as in a marble cake. The era of cooperative federalism contributed to the gradual incursion of national authority into the jurisdictional domain of the states, as well as the expansion of the national government’s power in concurrent policy areas. 33

The New Deal programs President Franklin D. Roosevelt proposed as a means to tackle the Great Depression ran afoul of the dual-federalism mindset of the justices on the Supreme Court in the 1930s. The court struck down key pillars of the New Deal—the National Industrial Recovery Act and the Agricultural Adjustment Act , for example—on the grounds that the federal government was operating in matters that were within the purview of the states. The court’s obstructionist position infuriated Roosevelt, leading him in 1937 to propose a court-packing plan that would add one new justice for each one over the age of seventy, thus allowing the president to make a maximum of six new appointments. Before Congress took action on the proposal, the Supreme Court began leaning in support of the New Deal as Chief Justice Charles Evans Hughes and Justice Owen Roberts changed their view on federalism. 34

In National Labor Relations Board (NLRB) v. Jones and Laughlin Steel , 35 for instance, the Supreme Court ruled the National Labor Relations Act of 1935 constitutional, asserting that Congress can use its authority under the commerce clause to regulate both manufacturing activities and labor-management relations. The New Deal changed the relationship Americans had with the national government. Before the Great Depression , the government offered little in terms of financial aid, social benefits, and economic rights. After the New Deal, it provided old-age pensions (Social Security), unemployment insurance, agricultural subsidies, protections for organizing in the workplace, and a variety of other public services created during Roosevelt’s administration.

In the 1960s, President Lyndon Johnson ’s administration expanded the national government’s role in society even more. Medicaid (which provides medical assistance to the indigent), Medicare (which provides health insurance to the elderly and some people with disabilities), and school nutrition programs were created. The Elementary and Secondary Education Act (1965), the Higher Education Act (1965), and the Head Start preschool program (1965) were established to expand educational opportunities and equality ( Figure 3.12 ). The Clean Air Act (1965), the Highway Safety Act (1966), and the Fair Packaging and Labeling Act (1966) promoted environmental and consumer protection. Finally, laws were passed to promote urban renewal, public housing development, and affordable housing. In addition to these Great Society programs, the Civil Rights Act (1964) and the Voting Rights Act (1965) gave the federal government effective tools to promote civil rights equality across the country.

While the era of cooperative federalism witnessed a broadening of federal powers in concurrent and state policy domains, it is also the era of a deepening coordination between the states and the federal government in Washington. Nowhere is this clearer than with respect to the social welfare and social insurance programs created during the New Deal and Great Society eras, most of which are administered by both state and federal authorities and are jointly funded. The Social Security Act of 1935, which created federal subsidies for state-administered programs for the elderly; people with disabilities; dependent mothers; and children, gave state and local officials wide discretion over eligibility and benefit levels. The unemployment insurance program, also created by the Social Security Act, requires states to provide jobless benefits, but it allows them significant latitude to decide the level of tax to impose on businesses in order to fund the program as well as the duration and replacement rate of unemployment benefits. A similar multilevel division of labor governs Medicaid and Children’s Health Insurance. 36

Thus, the era of cooperative federalism left two lasting attributes on federalism in the United States. First, a nationalization of politics emerged as a result of federal legislative activism aimed at addressing national problems such as marketplace inefficiencies, social and political inequality, and poverty. The nationalization process expanded the size of the federal administrative apparatus and increased the flow of federal grants to state and local authorities, which have helped offset the financial costs of maintaining a host of New Deal- and Great Society–era programs. The second lasting attribute is the flexibility that states and local authorities were given in the implementation of federal social welfare programs. One consequence of administrative flexibility, however, is that it has led to cross-state differences in the levels of benefits and coverage. 37

NEW FEDERALISM

During the administrations of Presidents Richard Nixon (1969–1974) and Ronald Reagan (1981–1989), attempts were made to reverse the process of nationalization—that is, to restore states’ prominence in policy areas into which the federal government had moved in the past. New federalism is premised on the idea that the decentralization of policies enhances administrative efficiency, reduces overall public spending, and improves policy outcomes. During Nixon’s administration, general revenue sharing programs were created that distributed funds to the state and local governments with minimal restrictions on how the money was spent. The election of Ronald Reagan heralded the advent of a “devolution revolution” in U.S. federalism, in which the president pledged to return authority to the states according to the Constitution. In the Omnibus Budget Reconciliation Act of 1981, congressional leaders together with President Reagan consolidated numerous federal grant programs related to social welfare and reformulated them in order to give state and local administrators greater discretion in using federal funds. 38

However, Reagan’s track record in promoting new federalism was inconsistent. This was partly due to the fact that the president’s devolution agenda met some opposition from Democrats in Congress, moderate Republicans, and interest groups, preventing him from making further advances on that front. For example, his efforts to completely devolve Aid to Families With Dependent Children (a New Deal-era program) and food stamps (a Great Society-era program) to the states were rejected by members of Congress, who feared states would underfund both programs, and by members of the National Governors’ Association, who believed the proposal would be too costly for states. Reagan terminated general revenue sharing in 1986. 39

Several Supreme Court rulings also promoted new federalism by hemming in the scope of the national government’s power, especially under the commerce clause. For example, in United States v. Lopez , the court struck down the Gun-Free School Zones Act of 1990, which banned gun possession in school zones. 40 It argued that the regulation in question did not “substantively affect interstate commerce.” The ruling ended a nearly sixty-year period in which the court had used a broad interpretation of the commerce clause that by the 1960s allowed it to regulate numerous local commercial activities. 41

However, many would say that the years since the 9/11 attacks have swung the pendulum back in the direction of central federal power. The creation of the Department of Homeland Security federalized disaster response power in Washington, and the Transportation Security Administration was created to federalize airport security. Broad new federal policies and mandates have also been carried out in the form of the Faith-Based Initiative and No Child Left Behind (during the George W. Bush administration) and the Affordable Care Act (during Barack Obama’s administration).

Finding a Middle Ground

Cooperative federalism versus new federalism.

The challenges of the 1930s led many to question the merits of dual federalism, where the states and the national governments exercised exclusive authority in distinctly delineated spheres of jurisdiction. The result was the birth of cooperative federalism. In this view of federalism, the jurisdictional boundaries between the national and state governments were eroded to allow for greater cooperation between both governments. While this expansion of national government power was crucial in tackling the problems of the Great Depression, environmental degradation, and civil rights abuses, many resented the federal incursions into what had earlier been state matters. These concerns led to the emergence of new federalism in the 1970s and '80s. New federalism was premised on the idea that the decentralization of policies enhanced administrative efficiency and improved outcomes. Rather than simply a return to the old dual federalism model, new federalism continued much of the federal spending but rolled back many of the restrictions on what states could do with their federal funds.

Cooperative federalism has several merits:

• Because state and local governments have varying fiscal capacities, the national government’s involvement in state activities such as education, health, and social welfare is necessary to ensure some degree of uniformity in the provision of public services to citizens in richer and poorer states.
• The problem of collective action, which dissuades state and local authorities from raising regulatory standards for fear they will be disadvantaged as others lower theirs, is resolved by requiring state and local authorities to meet minimum federal standards (e.g., minimum wage and air quality).
• Federal assistance is necessary to ensure state and local programs that generate positive externalities are maintained. For example, one state’s environmental regulations impose higher fuel prices on its residents, but the externality of the cleaner air they produce benefits neighboring states. Without the federal government’s support, this state and others like it would underfund such programs.

New federalism has advantages as well:

• Because of differences among states, one-size-fits-all features of federal laws are suboptimal. Decentralization accommodates the diversity that exists across states.
• By virtue of being closer to citizens, state and local authorities are better than federal agencies at discerning the public’s needs.
• Decentralized federalism fosters a marketplace of innovative policy ideas as states compete against each other to minimize administrative costs and maximize policy output.

Which model of federalism do you think works best for the United States? Why?

Link to Learning

The leading international journal devoted to the practical and theoretical study of federalism is called Publius: The Journal of Federalism . Find out where its name comes from.

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Federalism is the theory or advocacy of federal principles for dividing powers between member units and common institutions. Unlike in a unitary state, sovereignty in federal political orders is non-centralized, often constitutionally, between at least two levels so that units at each level have final authority and can be self governing in some issue area. Citizens thus have political obligations to, or have their rights secured by, two authorities. The division of power between the member unit and center may vary, typically the center has powers regarding defense and foreign policy, but member units may also have international roles. The decision-making bodies of member units may also participate in central decision-making bodies. Much recent philosophical attention is spurred by renewed political interest in federalism and backlashes against particular instances, coupled with empirical findings concerning the requisite and legitimate basis for stability and trust among citizens in federal political orders. Philosophical contributions have addressed the dilemmas and opportunities facing Canada, Australia, Europe, Russia, Iraq, Nepal, Ethiopia and Nigeria, to mention just a few areas where federal arrangements are seen as interesting solutions to accommodate differences among populations divided by ethnic or cultural cleavages yet seeking a common, often democratic, political order.

1. Taxonomy

2.1 some global perspectives, 2.2 western contributions, 3.1 reasons for a federal order rather than separate states or secession, 3.2 reasons to prefer federal orders over a unitary state, 4.1 sovereignty or federalism, 4.2 issues of constitutional and institutional design, 4.3 sources of stability, 4.4 division of power, 4.5 distributive justice, 4.6 democratic theory, 4.7 politics of recognition, contemporary, other internet resources, related entries.

Much valuable scholarship explicates the central terms ‘federalism’, ‘federation’ and ‘federal systems’ (cf. Wheare 1964, King 1982, Elazar 1987, Elazar 1987a, Riker 1993, Watts 1998).

A federal political order is here taken to be “the genus of political organization that is marked by the combination of shared rule and self-rule” (Watts 1998, 120). Federalism is the descriptive theory or normative advocacy of such an order, including principles for dividing final authority between member units and the common institutions.

A federation is one species of such a federal order; other species are unions, confederations, leagues and decentralised unions—and hybrids such as the present European Union (Elazar 1987, Watts 1998). A federation in this sense involves a territorial division of power between constituent units—sometimes called ‘provinces’, ‘cantons’, possibly ‘cities’, or confusingly ‘states’—and a common government. This division of power is typically entrenched in a constitution which neither a member unit nor the common government can alter unilaterally. The member unit and the common government both have direct effect on the citizenry—the common government operates “on the individual citizens composing the nation” (Federalist Paper 39)—and the authorities of both are directly elected (Watts 1998, 121). In comparison, decentralized authority in unitary states can typically be revoked by the central legislature at will. Many multilevel forms of governance may also be revised by units at one level without consent by bodies at other levels. Such entrenchments notwithstanding, some centralization often occurs owing to the constitutional interpretations by a federal level court in charge of settling conflicts regarding the scopes of final legislative and/or judicial authority.

In contrast, ‘confederation’ has come to mean a political order with a weaker center than a federation, often dependent on the constituent units (Watts 1998, 121). Typically, in a confederation a) member units may legally exit, b) the center only exercises authority delegated by member units, c) the center is subject to member unit veto on many issues, d) center decisions bind member units but not citizens directly, e) the center lacks an independent fiscal or electoral base, and/or f) the member units do not cede authority permanently to the center. Confederations are often based on agreements for specific tasks, and the common government may be completely exercised by delegates of the member unit governments. Thus many would count as confederations the North American states during 1776–1787, Switzerland 1291–1847, and the present European Union—though it has several elements typical of federations.

In symmetric ( con ) federations the member units have the same bundles of powers, while in asymmetric ( con ) federations such as Russia, Canada, the European Union, Spain, or India the bundles may be different among member units; some member units may for instance have special rights regarding language or culture. Some asymmetric arrangements involve one smaller state and a larger, where the smaller partakes in governing the larger while retaining sovereignty on some issues (Elazar 1987, Watts 1998).

A helpful categorisation among federal arrangements concerns the relationship between the central unit, member units and individuals. If the decisions made centrally do not involve member units at all, we may speak of separate ( split or compact ) federalism. Some issues may be the responsibility of the central unit, others belonging to the member units, where citizens vote their representatives directly to both bodies (U.S. Constitution Art. II Section 1; cf. Dahl 2001). Federations can involve member units in central decision-making in at least two different ways in various forms of interlocking (or cooperative ) federalism. Member unit representatives can participate within central bodies—in cabinets or legislatures—( collective agency compositional arrangement). Or they constitute one central body that interacts with other central bodies, for instance where member unit government representatives form an Upper House with power to veto or postpone decisions by majority or qualified majority vote ( divided agency / relational arrangements). These legal arrangements give rise to varieties of multi-level governance: continuous negotiations among authorities at different territorial levels (Marks 1993, Hooghe and Marks 2003, Scharpf 1983). Responsiveness to individuals may benefit from interlocking federalism, but often at the cost of transparency and accountability.

Several authors identify two quite distinct processes that lead to a federal political order (Friedrich 1968, Buchanan 1995, Stepan 1999 and others). Independent states may aggregate by ceding or pooling sovereign powers in certain domains for the sake of goods otherwise unattainable, such as security or economic prosperity. Such coming together federal political orders are typically arranged to constrain the center and prevent majorities from overriding a member unit. Examples include the present USA, Canada, Switzerland, and Australia. Holding together federal political orders develop from unitary states, as governments devolve authority to alleviate threats of unrest or secession by territorially clustered minorities. Such federal political orders often grant some member units particular domains of sovereignty e.g. over language and cultural rights in an asymmetric federation, while maintaining broad scope of action for the central government and majorities. Examples include India, Belgium and Spain.

In addition to territorially organized federal political orders, other interesting alternatives to unitary states occur when non-territorial member units are constituted by groups sharing ethnic, religious or other characteristics. These systems are sometimes referred to as ‘non-territorial’ federations. Karl Renner and Otto Bauer explored such arrangements for geographically dispersed cultural minorities, allowing them some cultural and “personal” autonomy without territorial self rule (Bauer 1903; Renner 1907; Bottomore and Goode 1978; cf. Tamir 1993 and Nimni 2005). Consociations consist of somewhat insulated groups in member units who in addition are represented in central institutions often governing by unanimity rather than by majority (Lijphart 1977).

2. History of Federalism

A wide-spread interest among political philosophers in topics concerning the centralised nation state have fuelled attention to historical contributions on unitary sovereignty. However, we can also identify a steady stream of contributions to the philosophy of federalism, also by those more well known for their arguments concerning centralised power (cf. Karmis and Norman 2005 for such readings). Much of the Western literature on federalism has focused on the unit of states. To underscore this bias, consider first some non-Western practices and theories of federal features.

We find federal modes of political organisation on many continents, and contributions to theories about federalism in written sources across philosophical traditions. A range of philosophical contributions underscore that federal perspectives can apply to a wide range of units other than the sovereign states central in European and U.S. thought.

The tribal organisation of the Māori in what is now New Zealand included family groups ( whanau ), who would work together and collaborate for defense as a clan ( hapū ). The tribe ( iwi ) would in turn operate as a federation among several hapū for common defense (Ballara 1998, 19).

Several extinct African societies had federal elements. Edward Wamala describes what we recognise as federal features in pre-14th century Ganda society, in what later became the kingdom of the Baganda, now part of Uganda. The power structures between the chief ( ssabataka ) and heads of tribes ( mutaka ) was one of primus inter pares . The tribes enjoyed immunity, in that the higher units should no usurp the responsibilities of the lower units of power but only promote the well-being of the lower units (Wamala 2004: 436–437)

Nahua (Aztek) culture illustrates multi-level federalism: Tlaxilacalli - badly translated and understood as “neighbourhoods” - would submit to the authority of the sovereign local polity, or altepetl , which then scaled up to autonomous mega-provinces ( huei altepetl ) and finally to the entire empire. At each level, submission was traded for autonomy, undercutting any attempt at direct centralising rule (Johnson 2017). In the 1428 triple alliance for military purposes among the three city-states ( altepeme ) of Tenochtitlan, Texcoco and Totoquihuatzin, each of these rules over their dependent altepetl without interference by the other two (Lockhart 1992).

The Confucian political philosopher Mencius (379–298 BC) laid out a three level ‘familial’ order (Chan 2003). The family had primary responsibility for those unable to care for themselves, and rulers should be the parents of the people. (Mencius 2003, 1B.13). When the family could not assist, the community network should provide support. Only when the community was unable would what we might call the state have an obligation to aid.

We find expressions of federalism in the third pillar of Islam: Obligatory charity in the form of zakat provided to certain needy persons outside one’s own household (Qur’an 9: 103). Every able Muslim must provide a fixed proportion of their net wealth—2.5%—to support others in need. The role of the state may vary when it comes to assess, collect and distribute zakat. In some states, the collection or distribution of zakat is the responsibility of civil society organisations or mosques. In other states, it is the government’s responsibility to either ensure that zakat is managed if Muslims fail to pay; or the whole system may be managed by the state (Bilo and Mechado 2018).

The sub-Saharan philosophy of Ubuntu has federal features that have also contributed to legal theory. The term ‘Ubuntu’ stems from the Nguni phrase “Umuntu ngumuntu ngabantu” meaning a person is a person through other persons. Ubuntu emphasises the harmonious relationships between persons as constitutive of the individual, underscoring compassion and commitment to one another’s growth (Mbiti 1969, Gädeke 2019, Metz 2011). The task of governments at various territorial levels is to promote harmonious flourishing and community of the constituent parts (Shutte 2001). Ubuntu was included in the epilogue of the 1993 Interim Constitution of South Africa, but not explicitly in its 1996 Constitution.

The confederacy among five (later six) Haudenosaunee (Iroquois) nations dates back to between the 12th and 15th century. The oral constitution—The Great Law of Peace—specified that each nation elected delegates, or sachems , who dealt with internal affairs. The confederacy’s Grand Council could not interfere with the internal affairs of each tribe, but would discuss particular matters of common concern such as war, peace, and treaty making. The Haudenosaunee practice of granting the member units immunity apparently influenced Benjamin Franklin’s and others’ call for a union among the English colonies (Fenton 1998). Iris Marion Young explored this tradition to develop a theory of federalism that would secure immunity and redress power imbalances (Young 2000; Levy 2008).

Aristotle (384–322 BC) provides an early Western example of federal thought, where some of the member units are not political. The tasks of households and villages is to secure individuals’ necessities of life. The city-state ( polis ) is a self-sufficient community of such households, clans and villages, for protection and fulfilment (Politics, III.9, 1280b).

Several of the early European contributors to federalist thought explored the rationale and weaknesses of centralised states as they emerged and developed in the 17th and 18th century. Johannes Althusius (1557–1630) is often regarded as the father of modern federalist thought. He argued in Politica Methodice Digesta (Althusius 1603) for autonomy of his city Emden, both against its Lutheran provincial Lord and against the Catholic Emperor. Althusius was strongly influenced by French Huguenots and Calvinism. As a permanent minority in several states, Calvinists developed a doctrine of resistance as the right and duty of “natural leaders” to resist tyranny. Orthodox Calvinists insisted on sovereignty in the social circles subordinate only to God’s laws. The French Protestant Huguenots developed a theory of legitimacy further, presented 1579 by an author with the telling pseudonym “Junius Brutus” in Vindiciae Contra Tyrannos . The people, regarded as a corporate body in territorial hierarchical communities, has a God-granted right to resist rulers without rightful claim. Rejecting theocracy, Althusius developed a non-sectarian, non-religious contractualist political theory of federations that prohibited state intervention even for purposes of promoting the right faith. Accommodation of dissent and diversity prevailed over any interest in subordinating political powers to religion or vice versa.

Since humans are fundamentally dependent on others for the reliable provision of requirements of a comfortable and holy life, we require communities and associations that are both instrumentally and intrinsically important for supporting [ subsidia ] our needs. Althusius, like Aristotle, included non-political units in his federal theory. Families, guilds, cities, provinces, states and other associations owe their legitimacy and claims to political power to their various roles in enabling a holy life, rather than to individuals’ interest in autonomy. Each association claims autonomy within its own sphere against intervention by other associations. Borrowing a term originally used for the alliance between God and men, Althusius holds that associations enter into secular agreements— pactum foederis —to live together in mutual benevolence.

Several early contributors explored what we may now regard as various species of federal political orders, partly with an eye to resolving inter-state conflicts.

Ludolph Hugo (ca. 1630–1704) was the first to distinguish confederations based on alliances, decentralized unitary states such as the Roman Empire, and federations, characterized by ‘double governments’ with territorial division of powers, in De Statu Regionum Germanie (1661) (cf. Elazar 1998; Riley 1976).

A recurring concern was tensions between federalism and conceptions of sovereignty. Samuel Pufendorf (1632–1684) maintained that sovereign states could at most “agree to intertwine for all time” in a confederation deciding by unanimity. Move to majority rule turned the legal order into an ‘irregular system’ closer to a state. If sovereignty is a unique site of final and independent authority, federations are no more than voluntary treaties among fundamentally independent states, argued Emmerik Vattel (1714–1767). Later thinkers challenged this understanding of sovereignty, in debates continuing to this day concerning the European Union. (MacCormick 1999, Schütze 2009).

In The Spirit of Laws (1748) Charles de Secondat, Baron de Montesquieu (1689–1755) argued for confederal arrangements as combining the best of small and large political units, without the disadvantages of either. On the one hand they could provide the advantages of small states such as republican participation and liberty understood as non-domination—that is, security against abuse of power. At the same time confederal orders secure the benefits of larger states such as military security, without the risks of small and large states. A ‘confederate republic’ with separation of powers allows sufficient homogeneity and identification within sufficiently small member units. The member units in turn pool powers sufficient to secure external security, reserving the right to secede (Book 9, 1). Member units serve as checks on each other, since other member units may intervene to quell insurrection and power abuse in one member unit. These themes reoccur in later contributions, up to and including discussions concerning the European Union (cf. Levy 2004, 2005, 2007).

David Hume (1711–1776) disagreed with Montesquieu that smaller size is better. Instead, “in a large democracy … there is compass and room enough to refine the democracy.” In “Idea of a Perfect Commonwealth” (Hume 1752) Hume recommended a federal arrangement for deliberation of laws involving both member unit and central legislatures. Member units enjoy several powers and partake in central decisions, but their laws and court judgments can always be overruled by the central bodies, hence it seems that Hume’s model is not federal as the term is used here. He held that such a numerous and geographically large system would do better than small cities in preventing decisions based on “intrigue, prejudice or passion” against the public interest.

Several 18th century peace plans for Europe recommended confederal arrangements. The 1713 Peace Plan of Abbé Charles de Saint-Pierre (1658–1743) would allow intervention in member units to quell rebellion and wars on non-members to force them to join an established confederation, and required unanimity for changes to the agreement.

Jean-Jacques Rousseau (1712–1778) presented and critiqued Saint-Pierre’s proposal, listing several conditions including that all major powers must be members, that the joint legislation must be binding, that the joint forces must be stronger than any single state, and that secession must be illegal. Again, unanimity was required for changes to the agreement.

Immanuel Kant (1724–1804) defended a confederation for peace in On Perpetual Peace (1796). His Second Definite Article of a Perpetual Peace holds that the right of nations shall be based on a pacific federation among free states rather than a peace treaty or an international state: “This federation does not aim to acquire any power like that of a state, but merely to preserve and secure the freedom of each state in itself, along with that of the other confederated states, although this does not mean that they need to submit to public laws and to a coercive power which enforces them, as do men in a state of nature.”

The discussions surrounding the U.S. Constitutional Convention of 1787 marks a clear development in federal thought, also as regards the tensions between unitary sovereignty and divided authority. One central feature is that federations were seen as uniting not only member units as in confederations, but also the citizenry directly.

The Articles of Confederation of 1781 among the 13 American states fighting British rule had established a center too weak for law enforcement, defense and for securing interstate commerce. What has become known as the U.S. Constitutional Convention met May 25–September 17, 1787. It was explicitly restricted to revise the Articles, but ended up recommending more fundamental changes. The proposed constitution prompted widespread debate and arguments addressing the benefits and risks of federalism versus confederal arrangements, leading eventually to the Constitution that took effect in 1789.

The “Anti-federalists” were fearful of undue centralization. They worried that the powers of central authorities were not sufficiently constrained e.g., by a bill of rights (John DeWitt 1787) that was eventually ratified in 1791. They also feared that the center might gradually usurp the member units’ powers. Citing Montesquieu, another pseudonymous ‘Brutus’ doubted whether a republic of such geographical size with so many inhabitants with conflicting interests could avoid tyranny and would allow common deliberation and decision based on local knowledge (Brutus (Robert Yates?) 1787).

In The Federalist Papers , James Madison (1751–1836), Alexander Hamilton (1755–1804) and John Jay (1745–1829) argued vigorously for the suggested model of interlocking federal arrangements (Federalist 10, 45, 51, 62). Madison and Hamilton agreed with Hume that the risk of tyranny by passionate majorities was reduced in larger republics where member units of shared interest could and would check each other: “A rage for paper money, for an abolition of debts, for an equal division of property, or for any improper or wicked project, will be less likely to pervade the whole body of the Union than a particular member of it.” (Federalist 10). Splitting sovereignty between member unit and center would also protect individuals’ rights against abuse by authorities at either level, or so believed Hamilton, quoting Montesquieu at length to this effect (Federalist 9).

Noting the problems of allocating powers correctly, Madison supported placing some authority with member units since they would be best fit to address “local circumstances and lesser interests” otherwise neglected by the center (Federalist 37).

Madison and Hamilton urged centralized powers of defense and interstate commerce (Federalist 11, 23), and argued for the need to solve coordination and assurance problems of partial compliance, through two new means: Centralized enforcement and direct applicability of central decisions to individuals (Federalist 16, also noted by Tocqueville 1835–40). They were wary of granting member units veto power typical of confederal arrangements, since that would render the center weak and cause “tedious delays; continual negotiation and intrigue; contemptible compromises of the public good.” (Madison and Hamilton, Federalist 22; and cf. 20).

They were particularly concerned to address worries of undue centralization, arguing that such worries should be addressed not by constraining the extent of power in the relevant fields, such as defense, but instead by the composition of the central authority (Federalist 31). They also claimed that the people would maintain stronger “affection, esteem, and reverence” towards the member unit government owing to its public visibility in the day-to-day administration of criminal and civil justice (Federalist 17).

John Stuart Mill (1806–1873), in chapter 17 of Considerations on Representative Government (1861), recommended federations among “portions of mankind” not disposed to live under a common government, to prevent wars among themselves and protect against aggression. He would also allow the center sufficient powers so as to ensure all benefits of union—including powers to prevent frontier duties to facilitate commerce. He listed three necessary conditions for a federation: sufficient mutual sympathy “of race, language, religion, and, above all, of political institutions, as conducing most to a feeling of identity of political interest”; no member unit so powerful as to not require union for defense nor tempt unduly to secession; and rough equality of strength among member units to prevent internal domination by one or two. Mill also claimed among the benefits of federations that they reduce the number of weak states hence reduce temptation to aggression, ending wars and restrictions on commence among member units; and that federations are less aggressive, only using their power defensively. Further benefits from federations—and from decentralized authority in general—might include learning from ‘experiments in living’.

Pierre-Joseph Proudhon (1809–1865), in Du Principe fédératif (1863) defended federalism as the best way to retain individual liberty within ‘natural’ communities such as families and guilds who enter pacts among themselves for necessary and specific purposes. The state is only one of several non-sovereign agents in charge of coordinating, without final authority.

While Proudhon was wary of centralisation, authors such as Harold Laski warned of ‘The Obsolesence of Federalism’ (1939). The important problems, such as those wrought by ‘giant capitalism,’ require more centralised responses than federal arrangements can muster.

Philosophical reflections on federalism were invigorated during and after the Second World War, for several reasons. Altiero Spinelli and Ernesto Rossi called for a European federal state in the Ventotene Manifesto , published 1944. They condemned totalitarian, centralised states and the never ending conflicts among them. Instead there should be enough shared control over military and economic power, yet “each State will retain the autonomy it needs for a plastic articulation and development of political life according to the particular characteristics of the various peoples.” Many explain and justify the European Union along precisely these lines, while others are more critical.

Hannah Arendt (1906–1975) traced both totalitarianism and industrialized mass murder to flaws in the sovereign nation-state model. Skeptical both of liberal internationalism and political realism, she instead urged a Republican federal model or ideal type wherein “the federated units mutually check and control their powers” (Arendt 1972).

The exit of colonial powers also left multi-ethnic states that required creative solutions to combine self rule and shared rule (Karmis and Norman 2005). In addition, globalisation has prompted not only integration and harmonisation, but also—partly in response—explorations of ways to still maintain some local self rule (Watts 1998).

Developments of the European Union and backlash against its particular forms of political and legal integration is one major cause of renewed attention to the philosophy of federalism. Recent philosophical discussions have addressed several issues, including centrally the reasons for federalism, and attention to the sources of stability and instability; the legitimate division of power between member unit and center; distributive justice, challenges to received democratic theory, and concerns about the politics of recognition.

3. Reasons for Federalism

Many arguments for federalism have traditionally been put in terms of promoting various forms of liberty in the form of non-domination, immunity or enhanced opportunity sets (Elazar 1987a). When considering reasons offered in the literature for federal political orders, many appear to be in favor of decentralization without requiring constitutional entrenchment of split authority. Two sets of arguments can be distinguished: Arguments favoring federal orders compared with secession and completely independent sovereign states; and arguments supporting federal arrangements rather than a (further) centralized unitary state. They occur in different forms and from different starting points, in defense of ‘coming together’ federalism, and in favor of ‘holding together’ federalism.

There are several suggested reasons for a federal order rather than separate states or secession.

• Federations can facilitate some objectives of sovereign states, such as credible commitments, certain kinds of coordination to secure ‘public goods’ of various sorts, and to control externalities that affect other parties, by transferring some powers to a common body. Since cooperation in some areas can ‘spill over’ and create demands for further coordination in other sectors, federations often exhibit creeping centralisation. Note that several of these objectives require getting the allocation of competences and veto points right within the federal order. For some complex common objectives such as environmental problems, federal features otherwise risk becoming part of the problem (Adler 2005, Dalmazzone 2006).

Federations may foster peace, in the senses of preventing wars and preventing fears of war, in several ways. States can join a (con)federation to become jointly powerful enough to dissuade external aggressors, and/or to prevent aggressive and preemptive wars among themselves. The European federalists Altieri Spinelli, Ernesto Rossi and Eugenio Colorni argued the latter in the 1941 Ventotene Manifesto: Only a European federation could prevent war between totalitarian, aggressive states. Such arguments assume, of course, that the (con)federation will not become more aggressive than each state separately, a point Mill argued.

Federations can promote economic prosperity by removing internal barriers to trade, through economies of scale, by establishing and maintaining inter-member unit trade agreements, or by becoming a sufficiently large global player to affect international trade regimes (for the latter regarding the EU, cf. Keohane and Nye 2001, 260).

Federal arrangements may protect individuals against political authorities by constraining state sovereignty, placing some powers with the center. By entrusting the center with authority to intervene in member units, the federal arrangements can protect minorities’ human rights against member unit authorities (Federalist, Watts 1999). Such arguments assume, of course, that abuse by the center is less likely.

Federal arrangements may enhance the political influence of formerly sovereign governments, both by facilitating coordination, and—particularly for small states—by giving these member units influence or even veto over policy making, rather than remaining mere policy takers.

Federal political orders can be preferred as the appropriate form of nested organizations, for instance in ‘organic’ conceptions of the political and social order. The federation may promote cooperation, justice or other values among and within member units as well as among and within their constituent units, for instance by monitoring, legislating, enforcing or funding agreements, human rights, immunity from interference, or development. Starting with the family, each larger unit responsible for facilitating the flourishing of member units and securing common goods beyond their reach without a common authority. Such arguments have been offered by such otherwise divergent authors as Althusius, the Catholic traditions of subsidiarity as expressed by popes Leo XIII (1891) and Pius XI (1931), and Proudhon.

There are several arguments that may apply in favor of federal orders over a unitary state. Among the challenges for some of these arguments is how to allocate authority when there are conflicting claims to provide different benefits for partly overlapping groups; and how to construct overrides in cases of emergencies such as pandemics (Steytler 2021). Who has the power to decide what are exceptions is important, even if we may disagree with Schmitt that it defines who is sovereign (Schmitt 1985).

Federal arrangements may protect against central authorities by securing immunity and non-domination for minority groups or nations. Constitutional allocation of powers to a member unit protects individuals from the center, while interlocking arrangements provide influence on central decisions via member unit bodies (Madison, Hume, Goodin 1996). Member units may thus check central authorities and prevent undue action contrary to the will of minorities: “A great democracy must either sacrifice self-government to unity or preserve it by federalism. The coexistence of several nations under the same State is a test, as well as the best security of its freedom … The combination of different nations in one State is as necessary a condition of civilized life as the combination of men in society” (Acton 1907, 277).

More specifically, federal arrangements can accommodate minority nations who aspire to self determination, political expressions of their sense of shared identity and belonging, and the preservation of their culture, language or religion (Carla 2012). Such autonomy and immunity arrangements are clearly preferable to the political conflicts that might result from such groups’ attempts at secession. Central authorities may respond with human rights abuses, civil wars or ethnic cleansing to prevent such secessionist movements.

Federal orders may increase the opportunities for citizen participation in public decision-making; through deliberation and offices in both member unit and central bodies that ensures character formation through political participation among more citizens (Mill 1861, ch. 15).

Federal orders may facilitate learning by fostering alternative solutions to similar problems and sharing lessons from such a laboratory of ‘experiments in living’ (Rose-Ackerman 1980).

Federations may facilitate efficient preference maximization more generally, as formalized in the literature on economic and fiscal federalism—though many such arguments support decentralization rather than federalism proper. Research on ‘fiscal federalism’ addresses the optimal allocation of authority, typically recommending central redistribution but local provision of public goods. Federal arrangements may allow more optimal matching of the authority to create public goods to specific affected subsets of the populations. If individuals’ preferences vary systematically by territory according to external or internal parameters such as geography or shared tastes and values, federal—or decentralized—arrangements that allow local variation may be well suited for several reasons. Local decisions prevent overload of centralised decision-making, and local decision-makers may also have a better grasp of affected preferences and alternatives, making for better service than would be provided by a central government that tends to ignore local preference variations (Smith 1776, 680). Granting powers to population subsets that share preferences regarding public services may also increase efficiency by allowing these subsets to create such ‘internalities’ and ‘club goods’ at costs borne only by them (Musgrave 1959, 179–80, Olson 1969, Oates’ 1972 ‘Decentralization Theorem’).

Federal arrangements can also shelter territorially based groups with preferences that diverge from the majority population, such as ethnic or cultural minorities, so that they are not subject to majority decisions severely or systematically contrary to their preferences. Non-unitary arrangements may thus minimize coercion and be responsive to as many citizens as possible (Mill 1861 ch. 15, Elazar 1968; Lijphart 1999). Such considerations of economic efficiency and majority decisions may favor federal solutions, with “only indivisibilities, economies of scale, externalities, and strategic requirements … acceptable as efficiency arguments in favor of allocating powers to higher levels of government” (Padou-Schioppa 1995, 155).

Federal arrangements may not only protect existing clusters of individuals with shared values or preferences, but may also promote mobility and hence territorial clustering of individuals with similar preferences. Member unit autonomy to experiment may foster competition for individuals who are free to move where their preferences are best met. Such mobility towards member units with like-minded individuals may add to the benefits of local autonomy over the provision of public services—absent economies of scale and externalities (Tiebout 1956, Buchanan 2001)—though the result may be that those with costly needs and who are less mobile are left worse off.

4. Further Philosophical Issues

Much recent attention has focused on philosophical issues arising from empirical findings concerning federalism (for an overview of such empirical research, cf. Burris 2015), and has been spurred by quite different dilemmas facing—inter alia—Canada, Australia, Nepal, Ethiopia, several European states and the European Union.

The tensions between sovereignty and federalism still pose puzzles, reflected in ‘international’ and ‘national’ understandings of the latter (Schütze 2009). If sovereignty is a unique site of final and independent authority, federal orders cannot be sovereign, since no one has the ‘last word’ on all political matters (Friedrich 1968), and “authority and power are dispersed among a network of arenas” (Elazar 1994, xiii). Another tradition, including Madison (Federalist Paper 39), and more recently Beaud (2009) and Schütze (2009), seeks to square the circle allowing dual sovereignty. Several contributions to the political and legal theory of the European Union resolve these issues in different directions (Bellamy 2019; Schütze 2020).

Federal political orders require attention to several constitutional and other institutional issues. The great variation and how the features interact require careful comparative studies to understand their impact on law and politics (Palermo and Kössler 2017). The design of federal orders raise peculiar and intriguing issues of normative political theory (Watts 1998; Norman 2006).

Composition: How to determine the boundaries of the member units, e.g., along geographical, ethnic or cultural lines; whether establishment of new member units from old should require constitutional changes, whether to allow secession and if so how, etc.

Distribution of Power: The allocation of legislative, executive, judicial and constitution-amending power between the member units and the central institutions. In asymmetric arrangements some of these may differ among member units.

Power Sharing: The form of influence by member units in central decision-making bodies within the interlocking political systems.

These tasks must be resolved taking due account of several important considerations noted below.

As political orders go, federal political arrangements pose peculiar problems concerning stability and trust. Federations tend to drift toward disintegration in the form of secession, or toward centralization in the direction of a unitary state.

Such instability should come as no surprise given the tensions typically giving rise to federal political orders in the first place, such as tensions between majority and minority national communities in multinational federations. Federal political orders are therefore often marked by a high level of ‘constitutional contestation’. The details of their constitutions and other institutions may affect these conflicts and their outcomes in drastic ways. Political parties often disagree on constitutional issues regarding the appropriate areas of member unit autonomy, the forms of cooperation and how to prevent fragmentation. Such sampling bias among states that federalize to hold together makes it difficult to assess often heard claims that federal responses such as granting some local autonomy perpetuate cleavages and fuel rather than quell secessionist movements. Some nevertheless argue that democratic, interlocking federations alleviate such tendencies (Simeon 1998, Simeon and Conway 2001, Linz 1997; cf. McKay 2001, Filippov, Ordeshook and Shvetsova 2004).

Many authors note that the challenges of stability must be addressed not only by institutional design, but also by ensuring that citizens have an ‘overarching loyalty’ or ‘federal spirit’ to the federation as whole in addition to loyalty toward their own member unit (Franck 1968, Linz 1997, Burgess 2012). The legitimate bases, content and division of such a public dual allegiance are central topics of political philosophies of federalism (Norman 1995a, Choudhry 2001). Some accept (limited) appeals to considerations such as shared history, practices, culture, or ethnicity for delineating member units and placing certain powers with them, even if such ‘communitarian’ features are regarded as more problematic bases for (unitary) political orders (Kymlicka 1995, Habermas 1996, 500). Debates about the existence of a ‘European demos’ and the need for a common ‘European identity’ merit more careful scrutiny (Habermas 1992). The appropriate consideration that voters and their member unit politicians should give to the interests of others in the federation in interlocking arrangements must be clarified if the notion of citizen of two commonwealths is to be coherent and durable. Several of these challenges are especially acute for ‘ethnic federalism’ when the member units are delineated along ethnic lines: Any ‘internal minorities’ of other ethnicity risk persecution, the prospects of an overarching loyalty are dimmer, and ethnic nationalism may fuel secessionist movements (Selassie 2003)

Another and related central philosophical topic is the critical assessment of alleged grounds for federal arrangements in general, and the division of power between member units and central bodies in particular, indicated in the preceding sections. Recent contributions include Knop et al . 1995, Kymlicka 2001, Kymlicka and Norman 2000, Nicolaidis and Howse 2001, Norman 2006. Among the important issues, especially due to the risks of instability, are:

How the powers should be allocated, given that they should be used—but may be abused—by political entrepreneurs at several levels to affect their claims. The concerns about stability require careful attention to the impact of these powers on the ability to create and maintain ‘dual loyalties’ among the citizenry.

How to ensure that neither member units nor the central authorities overstep their jurisdiction. As Mill noted, “the power to decide between them in any case of dispute should not reside in either of the governments, or in any functionary subject to it, but in an umpire independent of both.” (1861) Such a court must be sufficiently independent, yet not utterly unaccountable. Many scholars seem to detect a centralising tendency among such courts (Watts 1998).

How to maintain sufficient democratic control over central bodies when these are composed by representatives of the executive branch of member units? The chains of accountability may be too long for adequate responsiveness. This is part of the core concerns about a ‘democratic deficit’ in the European Union (Watts 1998, Føllesdal and Hix 2006).

Who shall have the authority to revise the constitutionally embedded division of power? Some hold that a significant shift in national sovereignty occurs when such changes may occur without the unanimity characteristic of treaties.

The “Principle of Subsidiarity” has often been used to guide the decisions about allocation of power. This principle has recently received attention owing to its inclusion in European Union treaties. It holds that authority should rest with the member units unless allocating them to a central unit would ensure higher comparative efficiency or effectiveness in achieving certain goals. This principle can be specified in several ways, for instance concerning which units are included, which goals are to be achieved, and who has the authority to apply it. The principle has multiple pedigrees, and came to recent political prominence largely through its role in quelling fears of centralization in Europe—a contested role which the principle has not quite filled (Fleiner and Schmitt 1996, Burgess and Gagnon 1993, Føllesdal 1998).

Regarding distributive justice, federal political orders must manage tensions between ensuring member unit autonomy and securing the requisite redistribution within and among the member units. Indeed, the Federalists regarded federal arrangements as an important safeguard against “the equal division of property” (Federalist 10). The political scientists Linz and Stepan may be seen as finding support for the Federalists’ hypothesis: Compared to unitary states in the OECD, the ‘coming together’ federations tend to have higher child poverty rate in solo mother households and a higher percentage of population over-sixty living in poverty. Linz and Stepan explain this inequality as stemming from the ‘demos constraining’ arrangements of these federations, seeking to protect individuals and member units from central authorities, combined with a weak party system. By comparison, the Constitution of Germany (not a ‘coming together’ federation) explicitly requires equalization of living conditions among the member units (Art. 72.2). Presbey argues that ethnic federalism further exacerbates unfair distribution of resources among individuals of different ethnic groups in Africa (Presbey 2003). Normative arguments may also support some distributive significance of federal arrangements, for instance owing to trade-offs between member unit autonomy and redistributive claims among member units (Føllesdal 2001), or the relevance of a shared ‘identity‘ (Grégoire and Jewkes 2015, de Schutter 2011). A central normative issue is to what extent a shared culture and bonds among citizens within a historically sovereign state reduce the claims on redistribution among the member units.

Federalism may increase citizens’ control over matters important to them but also raises several challenges to democratic theory, especially as developed for unitary states. Federal arrangements are often more complex, thereby challenging standards of transparency, accountability and public deliberation (Habermas 2001). The restricted political agendas of each center of authority also require defense (Dahl 1983; Braybrooke 1983). One of several sets of issues concern the standing of member units. Challenging puzzles concern federal orders where some or all units are not internally democratic (for further issues, cf., Norman 2006, 144–150).

The power that member units wield in federations often restricts or violates majority rule, in ways that merit careful scrutiny. Democratic theory has long been concerned with how to prevent domination of minorities, and many federal political orders do so by granting member units some influence over common decisions. Federal political orders typically influence individuals’ political influence by skewing their voting weight in favor of citizens of small member units, or by granting member unit representatives veto rights on central decisions. Minorities thus exercise control in apparent violation of principles of political equality and one-person-one-vote—more so when member units are of different size. These features raises fundamental normative questions concerning why member units should matter for the allocation of political power among individuals who live in different member units. Some of these puzzles are addressed in terms of ‘demoicracy’, especially regarding the European Union (van Parijs 1997, Nicolaidis 2012, Schütze 2020). Thus theorists disagree about whether every EU member state should maintain sovereignty in the sense of enjoying a veto for all decisions (Bellamy 2019, Cheneval et al 2015).

Many federal political orders accommodate minority groups in two ways discussed above: both through a division of power, and by granting them influence over common decisions. These measures of identity politics can be valuable ways to give public acknowledgment and recognition to groups and their members, sometimes on the very basis of previous domination. But identity politics also create challenges (Gutman 1994), especially in federal arrangements that face greater risks of instability and must maintain citizens’ dual political loyalties. Self-government arrangements may threaten the federal political order: “demands for self-government reflect a desire to weaken the bonds with the larger community and, indeed, question its very nature, authority and permanence” (Kymlicka and Norman 1994, 375). The emphasis on “recognition and institutionalization of difference could undermine the conditions that make a sense of common identification and thus mutuality possible” (Carens 2000, 193).

Federations are often thought to be sui generis , one-of-a-kind deviations from the ideal-type unitary sovereign state familiar from the Westphalian world order. Indeed, every federation may well be federal in its very own way, and not easy to summarize and assess as an ideal-type political order. Yet the phenomenon of non-unitary sovereignty is not new, and federal accommodation of differences may well be better than the alternatives. When and why this is so has long been the subject of philosophical, theoretical and normative analysis and reflection. Such public arguments may themselves contribute to develop the overarching loyalty required among citizens of stable, legitimate federations, who must understand themselves as members of two commonwealths.

Several of the historical writings—those marked ‘*’ below and others—are reprinted in part or full in Theories of Federalism: A Reader , Dimitrios Karmis and Wayne Norman (eds.), New York: Palgrave, 2005.

• Brutus, Junius (Philippe Duplessis-Mornay?), 1579, Vindiciae contra tyrannos , George Garnett (transl. and ed.), Cambridge: Cambridge University Press, 1994.
• *Althusius, Johannes, 1603, Politica Methodice Digesta , Frederick S. Carney (transl.), Daniel J. Elazar (introd.), Indianapolis: Liberty Press, 1995.
• Arendt, Hannah, 1972, “Thoughts on Politics and Revolution,” in Crises of the Republic , New York: Harcourt Brace, 199–233.
• Hugo, Ludolph, 1661, De Statu Regionum Germaniae. Helmstadt: Sumptibus Hammianis.
• Saint-Pierre, Abbé Charles, 1713, Projet pour rendre la paix perpêtuelle en Europe (Project to make peace perpetual in Europe), Paris: Fayard, 1986.
• *Montesquieu, Baron de, 1748, The Spirit of Laws , Amherst, NY: Prometheus Books, 2002.
• *Rousseau, Jean-Jacques, 1761, A Lasting Peace Through the Federation of Europe , C.E. Vaughan (trans.), London: Constable, 1917.
• *–––, 1761, “Summary and Critique of Abbé Saint-Pierre’s Project for Perpetual Peace,” in Grace G. Roosevelt (ed.), Reading Rousseau in the Nuclear Age , Philadelphia: Temple University Press, 1990.
• Hume, David, 1752, “Idea of a Perfect Commonwealth,” in T.H. Green and T.H. Grose (eds.), Essays moral, political and literary , London: Longmans, Green, 1882
• Smith, Adam, 1776, An Inquiry into the Nature and Causes of the Wealth of Nations , London: Dent, 1954.
• Storing, Herbert, and Murray Dry (eds.), 1981, The Complete Anti-Federalist (7 Volumes), Chicago: University of Chicago Press.
• *Hamilton, Alexander, James Madison, and John Jay, 1787–88, The Federalist Papers , Jacob E. Cooke (ed.), Middletown, CT: Wesleyan University Press, 1961.
• Kant, Immanuel, 1784, “An Answer to the Question: ‘What Is Enlightenment?’” in Hans Reiss (ed.), Kant’s Political Writings , Cambridge: Cambridge University Press, 1970, 54–60.
• *–––, 1796, “Perpetual Peace: A Philosophical Sketch,” in Hans Reiss (ed.), Kant’s Political Writings , Cambridge: Cambridge University Press, 1970, 93–130.
• *de Tocqueville, Alexis, 1835–40, Democracy in America , P. Bradley (ed.), New York: Vintage, 1945 [ Text available online ].
• *Mill, John Stuart, 1861, Considerations on Representative Government , New York: Liberal Arts Press, 1958 [ Text available online ].
• *Proudhon, Pierre Joseph, 1863, Du Principe Federatif , J.-L. Puech and Th. Ruyssen (eds.), Paris: M. Riviere, 1959.
• Leo XIII, 1891, “Rerum Novarum,” in The Papal Encyclicals 1903–1939 , Raleigh: Mcgrath, 1981.
• Renner, Karl, 1899, Staat und Nation , Vienna. Reprinted as “State and Nation” in Ephraim Nimni (ed.), National Cultural Autonomy and Its Contemporary Critics , London: Routledge, 2005, 64–82.
• Pius XI, 1931. “Quadragesimo Anno,” in The Papal Encyclicals 1903–1939 , Raleigh: Mcgrath, 1981.
• *Spinelli, Altiero, and Ernesto Rossi, 1944, Il manifesto di Ventotene ( The Ventotene Manifesto ), Naples: Guida, 1982; reprinted in Karmis and Norman 2005. [ Text available online ]
• Vattel, Emmerich, 1758 (2008), “The Law of Nations (Le Droit Des Gens),” in The Classics of International Law, edited by Bela Kapossy and Richard Whatmore , Indianapolis: Liberty Fund.

Secondary sources

• Aroney, Nicholas, 2007, “Subsidiarity, Federalism and the Best Constitution: Thomas Aquinas on City, Province and Empire,” Law and Philosophy , 26(2): 161–228.
• Dimitrios, Karmis, 2010, “Togetherness in Multinational Federal Democracies. Tocqueville, Proudhon and the Theoretical Gap in the Modern Federal Tradition,” in M. Burgess and A. G. Gagnon (eds.), Federal Democracies , Abingdon: Routledge, 46–63.
• Elazar, Daniel J., 1987, Federalism As Grand Design: Political Philosophers and the Federal Principle , Lanham, MD: University Press of America.
• Forsyth, Murray, 1981, Union of States: the Theory and Practice of Confederation , Leicester: Leicester University Press.
• Hueglin, Thomas O., 1999, Early Modern Concepts for a Late Modern World: Althusius on Community and Federalism , Waterloo, Ontario: Wilfrid Laurier University Press.
• Jewkes, Michael, 2016, “Diversity, Federalism and the Nineteenth-Century Liberals,” Critical Review of International Social and Political Philosophy , 19(2): 184–205.
• Klusmeyer, Douglas, 2010, “Hannah Arendt’s Case for Federalism,” Publius , 40(1): 31–58.
• Levinson, Sanford, 2015, An Argument Open to All: Reading “the Federalist” in the 21st Century , New Haven: Yale University Press.
• Riley, Patrick, 1973, “Rousseau As a Theorist of National and International Federalism,” Publius , 3(1): 5–18.
• –––, 1976, “Three Seventeenth-Century Theorists of Federalism: Althusius, Hugo and Leibniz,” Publius , 6(3): 7–42.
• –––, 1979, “Federalism in Kant’s Political Philosophy,” Publius , 9(4): 43–64.
• Stoppenbrink, Katja, 2016, “Representative Government and Federalism in John Stuart Mill,” in D. Heidemann and K. Stoppenbrink (eds.), Join, or Die: Philosophical Foundations of Federalism , Berlin: de Gruyter: 209–232.

Publius: The Journal of Federalism , regularly publishes philosophical articles.

Anthologies

• Bakvis, Herman, and William M. Chandler (eds.), 1987, Federalism and the Role of the State , Toronto: Toronto University Press.
• Bottomore, Tom and Patrick Goode (eds.), 1978, Austro-Marxism , Oxford: Oxford University Press.
• Burgess, Michael, and Alain G. Gagnon (eds.), 1993, Comparative Federalism and Federation: Competing Traditions and Future Directions , London: Harvester Wheatsheaf.
• –––, 2010, Federal Democracies , Abingdon: Routledge.
• Fleiner, Thomas, and Nicolas Schmitt (eds.), 1996, Towards European Constitution: Europe and Federal Experiences , Fribourg: Institute of Federalism.
• Fleming, James E., and Jacob T. Levy (eds.), 2014, Federalism and Subsidiarity , Nomos (Volume 55), New York: New York University Press.
• Franck, Thomas M. (ed.), 1968, Why Federations Fail: An Inquiry into the Requisites for Successful Federalism , New York: New York University Press.
• Gagnon, Alain-G., and James Tully (eds.), 2001, Multinational Democracies , Cambridge: Cambridge University Press.
• Gaudreault-DesBiens, Jean-François, and Fabien Gélinas (eds.), 2005, The States and Moods of Federalism: Governance, Identity and Methodology—Le Fédéralisme Dans Tous Ses États : Gouvernance, Identité Et Méthodologie Quebec: Éditions Yvon Blais.
• Grégoire, Jean-Francois, and Michael Jewkes, (eds.), 2015, Recognition and Redistribution in Multinational Federations , Leuven: Leuven University Press.
• Gutmann, Amy (ed.), 1994, Multiculturalism: Examining the Politics of Recognition , Princeton: Princeton University Press.
• Härtel, Ines (ed.), 2012, Handbuch Föderalismus: – Föderalismus als Demokratische Rechtsordnung und Rechtskultur in Deutschland, Europa und der Welt , 4 volumes, Berlin: Springer.
• Heidemann, Dietmar, and Katja Stoppenbrink (eds.), 2016, Join, or Die: Philosophical Foundations of Federalism , Berlin: De Gruyter.
• Karmis, Dimitrios, and Wayne Norman (eds.), 2005, Theories of Federalism: A Reader , New York: Palgrave.
• Kincaid, John (ed.), 2011, Federalism, 4 Vols. , Sage Library of Political Science London.
• Knop, Karen, Sylvia Ostry, Richard Simeon and Katherine Swinton (eds.), 1995, Rethinking Federalism: Citizens, Markets and Governments in a Changing World , Vancouver: University of British Columbia Press.
• Kymlicka, Will, and Wayne Norman (eds.), 2000, Citizenship in Diverse Societies , Oxford: Oxford University Press.
• Nicolaidis, Kalypso, and Robert Howse (eds.), 2001, The Federal Vision: Legitimacy and Levels of Governance in the US and the EU , Oxford: Oxford University Press.
• Nimni, Ephraim (ed.), 2005, National-Cultural Autonomy and its Contemporary Critics , Milton Park: Routledge.
• Steytler, Nico (ed.) 2021. Comparative federalism and Covid-19: Combating the Pandemic , Routledge.
• Trechsel, Alexander (ed.), 2006, Towards a Federal Europe , London: Routledge.
• Tushnet, Mark (ed.), 1990, Comparative Constitutional Federalism: Europe and America , New York: Greenwood Press.
• Ward, Ann, and Lee Ward (eds.), 2009, The Ashgate Research Companion to Federalism . Farnham: Ashgate.

Books and Articles

• Acton, Lord, 1907, “Nationality,” in J. N. Figgis (ed.), The History of Freedom and Other Essays , London: Macmillan.
• Adler, Joseph H., 2005, “Jurisdictional mismatch in environmental federalism,” New York University Environmental Law Journal , 14: 130–178.
• Ballara, Angela, 1998, Iwi: The Dynamics of Māori Tribal Organisation from C.1769 to C.1945 . Wellington: Victoria University Press
• Bauer, Otto, 2000, The Question of Nationalities and Social Democracy (with introduction by Ephraim Nimni), Minneapolis: University of Minnesota Press. [original 1907, Die Nationalitätenfrage und die Sozialdemokratie , Vienna].
• Beaud, Olivier, 2009. Théorie de la Fédération (2nd ed) . Paris, PUF.
• Beer, Samuel H., 1993, To Make a Nation: the Rediscovery of American Federalism , Cambridge, MA: Harvard University Press.
• Bellamy, Richard, 2019, A Republican Europe of States: Cosmopolitanism, Intergovernmentalism and Democracy in the EU . Cambridge, Cambridge University Press.
• Bilo, Charlotte, and Anna Carolina Mechado, 2018, “The Role of Zakat in the Provision of Social Protection – a Comparison between Jordan, Palestine and Sudan,” International Journal of Sociology and Social Policy 40, no. 3/4: 236–48.
• Braybrooke, David, 1983, “Can Democracy Be Combined With Federalism or With Liberalism?” , in J. R. Pennock and John W. Chapman (eds.), Nomos XXV: Liberal Democracy , New York, London: New York University Press.
• Buchanan, James, 1995, “Federalism as an ideal political order and an objective for constitutional reform,” Publius , 25(2): 19–27.
• –––, 1999/2001, Federalism, Liberty and the Law , Collected Works (Volume 18), Indianapolis: Liberty Fund.
• Burgess, M. 2012, In Search of the Federal Spirit: New Comparative Empirical and Theoretical Perspectives , Oxford University Press.
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How to cite this entry . Preview the PDF version of this entry at the Friends of the SEP Society . Look up topics and thinkers related to this entry at the Internet Philosophy Ontology Project (InPhO). Enhanced bibliography for this entry at PhilPapers , with links to its database.

• Liberty Library of Constitutional Classics [Contains many e-texts of primary sources] (maintained by the Constitution Society at constitution.org)
• Daniel J. Elazar’s writings on federalism (maintained at the Jerusalem Center for Public Affairs)

Arendt, Hannah | authority | citizenship | Hume, David | identity politics | Kant, Immanuel | liberty: positive and negative | Mill, John Stuart | Montesquieu, Charles-Louis de Secondat, Baron de | -->Proudhon, Pierre --> | Rousseau, Jean Jacques | sovereignty

Acknowledgements

This entry has benefited from suggestions by Andrea Carla, Federica Cittadino, Philippe Crignon, Dorothea Gädeke, Douglas Klusmeyer, Silje Langvatn, Petra Malfertheiner, Thaddeus Metz, Francesco Palermo, Antoinette Scherz, Robert Schütze, and Katja Stoppenbrink, and from exchanges at a Conference on Federalism 2022 at EHESS, Paris, and at the Eurac institutes for minority rights and for federalism, Bolzano, 2022.

Copyright © 2022 by Andreas Follesdal < andreas @ follesdal . net >

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This lesson includes

Guiding Questions

• How has the Constitutional principle of federalism shaped government policies over time?
• How does the legacy of slavery relate to the principle of federalism?
• To what extent and in what ways have the powers and functions of the two levels of government changed in the 20th and 21st centuries?
• How has the Supreme Court interpreted the Commerce Clause?
• How did Founders Roger Sherman and James Madison understand federalism?
• Students will describe functions of the national government according to Article I of the Constitution.
• Students will explain how the Constitution in Article IV and the Tenth Amendment both prohibits and enables certain state powers.
• Students will define terms: expressed, enumerated, and reserved powers.
• Students will analyze primary sources and the Constitution in order to understand the principle of federalism.

Expand Materials Materials

Student handouts, handout a: federalism venn diagram, handout b: article i sections 8, 9, 10 of the constitution and the tenth amendment.

• Handout C: State Power – Criticisms and Responses
• Handout D: Excerpts from Roger Sherman, June 6, 1787 (From Madison’s Notes on the Philadelphia Convention)
• Handout E: Excerpts from Federalist No. 39, James Madison (1788)
• Handout F: Excerpts from Democracy in America, Advantages of the Federal System, Alexis de Tocqueville (1835)

Handout G: An Overview of Federalism at the Founding and Early Republic

Handout h: how has the supreme court interpreted the commerce clause, handout i: commerce clause timeline.

Optional (Supplemental) Videos:

All videos can be found on the Bill of Rights Institute’s YouTube Channel

• Federalism | BRI’s Homework Help Series (4:40)
• Bill of Rights For Real Life: Federalism (10:08)
• Federalism and the Clarification of Slavery | Dr. Nicholas Cole | BRI’s Constitutional Conversations (5:03)
• U.S. v. Lopez | BRI’s Homework Help Series (5:56)
• What is Self-Governance and Why is it Important? | Dr. David Bobb | Constitutional Conversations (4:53)

Expand Key Terms Key Terms

• Alexis de Tocqueville
• Articles of Confederation
• Commerce Clause
• Constitution
• Decentralization/devolution
• Due process
• Electoral College
• Federalist No. 39
• Gibbons v. Ogden (1824)
• Great Depression
• James Madison
• Separation of powers
• Sixteenth Amendment
• Tenth Amendment
• United States v. Lopez (1995)

Expand Warmup Warmup

To begin, activate students’ prior knowledge by having them complete Handout A: Federalism Venn Diagram in order to differentiate which functions of government are best delegated to which level, state or federal. Discuss students’ answers as a whole group.

BRI Homework Help Video Federalism: https://youtu.be/QyCe2vxhp_Y

Expand Activities Activities

Have students use  Handout B: Article I Sections 8, 9, 10 of the Constitution and the Tenth Amendment  to review passages from the U.S. Constitution in order to understand how it distributes government powers. Students will write a title for each section or amendment, compare the ways in which power was divided between the states and federal government, explain the Founders reasoning for dividing power, and identifying the ways in which rights are protected in these articles and amendments. Have students discuss how their answers on  Handout A  might change based on their understanding from  Handout B .

Then students will consider a short essay to learn how the legacy of slavery is related to the principle of federalism by reading Handout C: State Power – Criticisms and Responses . Use the critical thinking questions to discuss with students how federalism was related to slavery and segregation in American history.

Have students read the following primary source excerpts to establish an understanding of how thinkers in the eighteenth and nineteenth centuries expected the principle of federalism to be applied. This activity might be done jigsaw style. (Divide the class into 3 sections, forming study groups, and assign one of the three documents to each section. Then form new groups to discuss all three documents. These sharing groups should consist of one or two students who worked on each of the three selections.)

• Handout F: Excerpts from Democracy in America, Advantages of the Federal System, Alexis de Tocqueville (1835) 

Have students work in their sharing groups to complete  Handout G: An Overview of Federalism at the Founding and Early Republic  to analyze the roles of the national and federal government according to each author.

Have students trace how interpretations of the Commerce Clause have changed the nature of federalism in the twentieth and twenty-first centuries by reading  Handout H: “How Has the Supreme Court Interpreted the Commerce Clause?” and completing  Handout I: Commerce Clause Timeline .

Expand Wrap Up Wrap Up

Whole group discussion: How has the Constitutional principle of federalism shaped government policies over time? Use specific documents and historical examples to support your comments.

Expand Homework Homework

Students will create a poster of federalism highlighting one part of American history. Students could research one topic within the lesson: a SCOTUS case, Jim Crow laws, New Deal programs; Commerce Clause.  Students must answer the question within their poster: How has the Constitutional principle of federalism shaped government policies over time?

Handout C: State Power Criticisms and Responses

Handout d: excerpts from roger sherman, june 6, 1787 (from madison’s notes on the philadelphia convention), handout e: excerpts from federalist no. 39, james madison (1788), handout f: excerpts from democracy in america, advantages of the federal system, alexis de tocqueville (1835).

Next Lesson

Related Resources

Through the Constitution’s system of federalism power was divided between national and subnational governments allowing citizens to decide local questions for themselves. This decentralization he contended draws individuals out of private life and compels them to civic engagement.

Legislative Branch

Understanding Federalism

Each of the five activities in this lesson introduces a different aspect of federalism. Introducing Federalism explores everyday situations that demonstrate the influence of federalism. The Historic Roots of Federalism shows students how the Articles of Confederation and the Constitution are grounded in federalism. Federalism in the Constitution explores federalism as described in Article I of the Constitution. Federalism in History uses historic legislation to illustrate how the relationship between the Federal government and the states has changed over time. Federalism in Everyday Life uses everyday experience to show the overlap among the different levels of government. The activities can be completed separately over the course of several classes.

Students will learn about federalism and its role in civic life by completing one or more of the activities.

Guiding Question

What is federalism, and how does this constitutional principle influence government and civic life in the United States?

6 Worksheets

Answer Keys

Recommended Grade Levels

Civics; U.S. Government

Time Required

Each activity requires approximately 30 minutes to complete. Activity 5 has two optional parts which can be done in class or as homework assignments.

Learning Activities

Activity 1: Introducing Federalism

• What is the definition of federalism? A system of government divided among local, state, and national responsibilities.
• Why is federalism an important civic concept to understand? People encounter and interact with different levels of government—local, state, and Federal—every day.
• Distribute Worksheet 1. Instruct each student to use the definitions for each term to fill out the remaining two columns. The column for "Visual Representation" should be completed with an illustration showing the level of government and what it presides over. (E.g., a representation of the Federal government presiding over the states.) Check the students' work using the Worksheet 1 Answer Key.
• Distribute Worksheet 2. Instruct each student to answer the questions, write the explanation called for, and fill out the diagram following the directions on the worksheet. Check the students' work using the Worksheet 2 Answer Key.

Activity 2: The Historic Roots of Federalism

• Federalism has not had one set definition throughout history, because the idea of the appropriate balance of authority among the local, state, and Federal governments has changed over time.
• Federalism is not specifically defined in the Constitution, but its meaning is suggested in how the national government is described.
• How is the role of the states different in the two preambles? Under the Articles of Confederation the states were partners in the union and had power over the action of the Federal government. The relationship of the states to the Federal government was not mentioned in the Preamble of the Constitution.
• Does the difference in the role of the states suggest a change in the meaning of federalism? Federalism under the Articles of Confederation meant that all states had to agree to each action of the Federal government in order for the Federal government to act. The role of the states and their relationship is not spelled out in the Preamble of the Constitution.

Activity 3: Federalism in the Constitution

• Discuss the concept of enumerated powers (powers granted to the Federal government), denied powers, and reserved power in the Constitution.
• Distribute Worksheet 4. Instruct the students to read the excerpt from the Constitution, and label each power as either E for enumerated power, D for denied power, or R for reserved power. Check the students' work using the Worksheet 4 Answer Key.
• Conduct a class discussion on the following question to check the students' understanding: (A suggested answer is italicized following the question.)
• Which clause of Article I, Section 8 do you think has the greatest influence on the discussion of Federalism? The answers can vary, but the most solid case might be made for Article I, Section 8 "To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof."
• The Tenth Amendment does not list any specific powers. What does that mean? The Tenth Amendment broadly says that all powers not given to the national government are reserved for the states and the people. This leaves the meaning of reserved powers open to interpretation.
• In what ways might the Tenth Amendment influence the interpretation of the Enumerated Powers? The Tenth Amendment suggests that the states have undefined powers reserved to them. Determining the extent of the authority reserved to the states by this amendment has been a long-running debate in U.S. history.

Activity 4: Federalism in History

• Introduce the students to the idea that the balance of authority between the Federal government and the states has shifted at different times in American history.
• Explain how legislation can grant new authority or responsibility to Federal, state, or local government.
• Distribute Worksheets 5. This worksheet presents two famous acts of legislation that changed the balance of authority between the Federal government and the states during the 20th century. Each example invites an assessment of the balance of authority over a topic. Check the students' work using the Worksheet 5 Answer Key.

Activity 5: Federalism in Everyday Life

• Remind the students of how Worksheet 2 illustrated the overlap among the levels of government. Explain that, as a consequence, we often see examples in everyday life that demonstrate the overlapping authority of different levels of government.
• Distribute Worksheet 6 to the students. Completing this worksheet will illustrate how federalism is encountered every day, and how the responsibilities of the three levels of government are interconnected.

Optional Activity

• The optional activity printed on page two of Worksheet 6 invites the students to identify how they experience the constitutional concept of federalism in everyday life.
• Ask the students to present their experience of federalism to the class by making a PowerPoint, poster, or video.

Additional Resources

Did you like this lesson? Educators who used this lesson also viewed:

• Teaching Six Big Ideas in the Constitution - Students engage in a study of the U.S. Constitution and the significance of six big ideas contained in it: limited government; republicanism; checks and balances; federalism; separation of powers; and popular sovereignty.

Return to Lesson Plans

If you have problems viewing this page, please contact [email protected] .

State and Federal Constitution

Module 3: federalism.

• Define federalism and explain its consequences for American politics and policy.
• Outline what the Constitution says about division of power between national and state governments and states' obligations to each other, and trace the increasing importance of the national government.
• Characterize the shift from dual to cooperative federalism and the role of fiscal federalism in intergovernmental relations today
• Assess the impact of federalism on democratic government and the scope of government.

• American Government Chapter 3
• Supplemental Reading: US Constitution, 10th Amendment
• Supplemental Reading: US Constitution, Article IV
• Supplemental Reading: AZ Constitution, Article VIII

Chapter Summary

Defining federalism, the constitutional basis of federalism, intergovernmental relations today, understanding federalism, assignments.

• Module 3 Quiz

Written Assignments

• Constitutional Design Assignment
• Research Paper Assignment

Licenses and Attributions

Cc licensed content, shared previously.

• Module 3: Federalism. Authored by : Mike Cook. Provided by : Pima Community College. License : CC BY: Attribution
• Module 3 Intro. Authored by : Mike Cook. Provided by : Pima Community College. License : CC BY: Attribution
• American Government Chapter 3. Provided by : OpenStax. Located at : https://openstax.org/books/american-government/pages/3-introduction . License : CC BY: Attribution

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Federalism in India after the 2024 General Election

 Syllabus: Centre-State Relations

 Source: TH

Context:   The aftermath of the 2024 general election in India has brought to light a significant shift towards increased democratization , with regional parties gaining substantial representation in Parliament. This development is expected to bolster federalism in India.

What is Federalism ?  

Federalism is a system of government that combines a central or “federal” government with regional governments within a single political framework, distributing powers between them. In India, the Constitution outlines the structure of governance, delineating the relationship between the federal government and state governments. Legislative, administrative, and executive powers are divided between the Union government and the states through the Union List, State List, and Concurrent List .

Features of Indian Federalism :

• Multilevel Government : Federalism entails the existence of two or more tiers of government, typically a central or federal government and regional or state governments.
• Separate Jurisdiction: Each level of government possesses its own authority and autonomy in areas such as legislation, taxation, and administration, even though they govern the same populace.
• Constitutional Specification : The powers and functions of each tier of government are clearly delineated and safeguarded by the Constitution, ensuring a balance of authority.
• Dispute Resolution Mechanism : The Supreme Court is vested with the authority to adjudicate disputes arising between state governments, providing a mechanism for resolving conflicts within the federal structure.

What does the 2024 Election result mean for Indian federalism?  

• Increase in regional party representation in Parliament.
• Diverse composition in ruling coalition and opposition.
• Potential for more inclusive governance .
• Voter preference for addressing local issues
• The challenge to traditional dominance of central parties .
• Concerns over central policies undermining state autonomy.
• Tensions over resource allocation and political rhetoric during the campaign.

Challenges to Centre-State Relations :

The concept of cooperative federalism :

It i mplies a system of governance where central and state governments collaborate and work together to achieve common goals, respecting each other’s constitutional boundaries.

Constitutional Boundaries between Centre and States:

• Division of Powers: The Constitution of India divides powers between the Union and state governments through three lists in the Seventh Schedule: Union, state and concurrent lists.
• The doctrine of Pith and Substance: This doctrine is used by courts to determine under which list a particular legislation falls. If the core subject matter of legislation falls within a list assigned to one level of government, the law is deemed valid even if it incidentally encroaches on a subject in another list.

Some examples to illustrate the spirit of cooperative federalism :

• GST Council : The GST Council, which includes representatives from both the central and state governments, is tasked with making decisions on tax rates, exemptions, and the implementation of GST. This collaborative framework ensures that both levels of government have a say in the tax policy, balancing regional interests with national priorities.
• Disaster Management: In the event of natural disasters, such as floods, earthquakes, or pandemics, the central government often works closely with state governments. For instance, during the COVID-19 pandemic, the Centre issued guidelines and provided resources, but states had the flexibility to adapt these guidelines to their local contexts. This allowed for a more tailored response, accommodating the diverse conditions across states.
• National Education Policy (NEP) 2020 : While the policy outlines broad national objectives, it allows states to customise and implement reforms according to their specific needs and contexts.
• River Water Disputes : The Inter-State River Water Disputes Act allows the central government to set up tribunals to adjudicate disputes, but the implementation of tribunal awards requires cooperation from the states involved. For instance, the resolution of the Cauvery water dispute involved extensive consultations and compliance from both Karnataka and Tamil Nadu, overseen by the central government.
• Niti Aayog : NITI Aayog acts as the quintessential platform for the Government of India by bringing States together as ‘Team India’ to work towards the national development agenda.

Strengthening Federalism:

• Strengthening of Inter-State Council: Over the years multiple committees have recommended strengthening of the Interstate Council where the concurrent list subjects can be debated and discussed, balancing Centre state powers.
• Democratic Decentralisation of administration and strengthening governments at all levels in true spirit. Power should be decentralised based on the principle of subsidiarity.
• Increase Resource Devolution : Raising the current 41% resource devolution from the Centre to the States can empower states, enabling more localized governance.
• Fair Finance Commission Practices : The Sixteenth Finance Commission should strive for equitable treatment of all states, reducing friction and promoting fairer resource distribution, especially benefiting poorer states to address inequality.
• Enhance State Autonomy : By diminishing the central government’s control in programs such as the Public Distribution System and MGNREGS, states can affirm their constitutional roles as equal partners in governance, preventing central dominance over state initiatives.

Conclusion:

For the central government to exercise its powers within constitutional boundaries in the spirit of cooperative federalism, it must engage in continuous dialogue, respect the autonomy of states, and ensure that policies and decisions are made collaboratively. This approach not only strengthens the federal structure but also promotes a more inclusive and responsive governance system.

Insta Links:

• Federal system of India- federalism with tilt towards centre

Mains Links:

  Though the federal principle is dominant in our constitution and that principle is one of its basic features, but it is equally true that federalism under the Indian Constitution leans in favour of a strong Center, a feature that militates against the concept of strong federalism. Discuss. (UPSC 2014)

Prelims Links:

Which one of the following is not a feature of Indian federalism? (UPSC 2017)

(a) There is an independent judiciary in India. (b) Powers have been clearly divided between the Centre and the States. (c) The federating units have been given unequal representation in the Rajya Sabha. (d) It is the result of an agreement among the federating units.

Local self-government can be best explained as an exercise in (USPC 2017)

(a) Federalism (b) Democratic decentralization (c) Administrative delegation (d) Direct democracy

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Proposed Rule

N-methylpyrrolidone (nmp); regulation under the toxic substances control act (tsca).

A Proposed Rule by the Environmental Protection Agency on 06/14/2024

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FOR FURTHER INFORMATION CONTACT:

Supplementary information:, i. executive summary, a. does this action apply to me, 2. applicability to importers and exporters, b. what is the agency's authority for taking this action, c. what action is the agency taking, d. why is the agency taking this action, e. what are the estimated incremental impacts of this action, ii. background, a. overview of n-methylpyrrolidone, b. regulatory actions pertaining to nmp, c. consideration of occupational safety and health administration (osha) occupational health standards in tsca risk evaluations and tsca risk management actions, 1. osha requirements, a. general duty clause of the osh act, b. osha standards, 2. consideration of osha standards in tsca risk evaluations, a. risk characterization for unreasonable risk determination, b. risk evaluation to inform risk management requirements, 3. consideration of osha standards in tsca risk management actions, 4. nmp and osha requirements, 5. nmp and other occupational exposure limits, d. summary of epa's risk evaluation activities on nmp, 1. 2020 risk evaluation, 2. revised unreasonable risk determination, 3. fenceline screening analysis, iii. regulatory approach, a. background, 1. consultations, 2. other stakeholder engagement, 3. children's environmental health, b. regulatory assessment of nmp, 1. description of conditions of use, a. manufacturing, b. processing, c. industrial and commercial use, d. consumer uses, e. disposal, f. terminology in this proposed rule, 2. description of unreasonable risk under the conditions of use, 3. description of tsca section 6 requirements for risk management, iv. proposed and alternative regulatory actions, a. proposed regulatory action, 1. prohibition of certain occupational uses and manufacturing, processing, and distribution in commerce of nmp for those uses, 2. container size restrictions and labeling requirements, 3. workplace chemical protection program (wcpp) for certain conditions of use, a. overview, b. direct dermal contact control (ddcc) requirements, c. personal protective equipment (ppe) program, d. general wcpp requirements, 4. prescriptive controls, b. concentration limits for industrial and commercial uses, c. workplace requirements, d. recordkeeping, e. compliance timeframes, 5. concentration limits on nmp in products for consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives, 6. mission- or safety-critical uses of nmp by dod and nasa, b. self-certification requirements, c. recordkeeping and downstream notification, 7. other requirements, a. recordkeeping, b. downstream notification, b. primary alternative regulatory action, 2. prohibition, c. overview of conditions of use and proposed regulatory action and alternative regulatory action, v. rationale for the proposed regulatory action and alternative regulatory action, a. consideration of risk management requirements available under tsca section 6(a), 1. proposed regulatory action, a. prohibition, b. container size restrictions, d. prescriptive controls, e. concentration limit for consumer use in adhesives and sealants, 2. alternative regulatory actions, 3. risk management requirements considered but not proposed, 4. additional considerations, b. consideration of alternatives in deciding whether to prohibit or substantially restrict nmp, vi. tsca section 6(c)(2) considerations, a. health effects of nmp and the magnitude of human exposure to nmp, b. environmental effects of nmp and the magnitude of exposure of the environment to nmp, c. benefits of nmp for various uses, d. reasonably ascertainable economic consequences of the proposed rule, 1. likely effect of the rulemaking on the national economy, small business, technological innovation, the environment, and public health, 2. costs and benefits of the proposed regulatory action and of the alternative regulatory actions considered by the administrator, 3. cost effectiveness of the proposed regulatory action and alternative regulatory actions considered by the administrator, vii. tsca section 9 analysis, section 14, and section 26 considerations, a. tsca section 9(a) analysis, b. tsca section 9(b) analysis, c. tsca section 14 requirement, d. tsca section 26 considerations, viii. requests for comment, ix. references, x. statutory and executive order reviews, a. executive orders 12866: regulatory planning and review and 14094: modernizing regulatory review, b. paperwork reduction act (pra), c. regulatory flexibility act (rfa), 1. need for the rule, 2. objectives and legal basis, 3. description and number of small entities to which the rule will apply, 4. projected compliance requirements, self-certification-related information generation, recordkeeping, and notification requirements, a. classes of small entities subject to the compliance requirements, b. professional skills needed to comply, 5. relevant federal rules, 6. significant alternatives to the proposed rule, d. unfunded mandates reform act (umra), e. executive order 13132 : federalism, f. executive order 13175 : consultation and coordination with indian tribal governments, g. executive order 13045 : protection of children from environmental health risks and safety risks, h. executive order 13211 : actions concerning regulations that significantly affect energy supply, distribution, or use, i. national technology transfer and advancement act (nttaa), j. executive order 12898 : federal actions to address environmental justice in minority populations and low-income populations and executive order 14096 : revitalizing our nation's commitment to environmental justice for all, list of subjects in 40 cfr part 751, part 751—regulation of certain chemical substances and mixtures under section 6 of the toxic substances control act.

• Subpart C—n-Methylpyrrolidone

Subpart C—n-Methylpyrrolidone (NMP)

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Environmental Protection Agency (EPA).

Proposed rule.

The Environmental Protection Agency (EPA or the “Agency”) is proposing to address the unreasonable risk of injury to human health presented by n-methylpyrrolidone (NMP) under its conditions of use as documented in EPA's risk evaluation and risk determination for NMP pursuant to the Toxic Substances Control Act (TSCA). NMP is a widely used solvent in a variety of industrial, commercial, and consumer applications including the manufacture and production of electronics such as semiconductors, polymers, petrochemical products, paints and coatings, and paint and coating removers. EPA determined that NMP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to NMP, including developmental post-implantation fetal loss from short-term exposure and reduced fertility and fecundity from long-term exposure. Additional adverse effects associated with exposure to NMP include liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin irritation, and sensitization. To address the identified unreasonable risk, EPA is proposing to: prohibit the manufacture (including import), processing, and distribution in commerce and use of NMP in several occupational conditions of use; require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational conditions of use; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements.

Comments must be received on or before July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 15, 2024.

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0744, through the Federal eRulemaking Portal at https://www.regulations.gov . Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets/​ .

For technical information contact: Clara Hull, Existing Chemicals Risk Management Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-3954; email address: [email protected] .

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected] .

You may be potentially affected by the proposed action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of NMP or products containing NMP. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities include:

• Abrasive Product Manufacturing (NAICS Code 327910);
• Adhesive Manufacturing (NAICS Code 325520);
• Aerospace Product and Parts Manufacturing (NAICS Code 336400);
• Agriculture, Construction, and Mining Machinery Manufacturing (NAICS Code 333100);
• Aircraft Manufacturing (NAICS Code 336411);
• All Other Automotive Repair and Maintenance (NAICS Code 811198);
• All Other Basic Organic Chemical Manufacturing (NAICS Code 325199);
• All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS Code 325998);
• All Other Miscellaneous Electrical Equipment and Component Manufacturing (NAICS Code 335999);
• All Other Miscellaneous Manufacturing (NAICS Code 339999);
• All Other Miscellaneous Store Retailers (except Tobacco Stores) (NAICS Code 453998);
• All Other Plastics Product Manufacturing (NAICS Code 326199);
• All Other Specialty Trade Contractors (NAICS Code 238990);
• Alumina and Aluminum Production and Processing (NAICS Code 331300);
• Appliance Repair and Maintenance (NAICS Code 811412);
• Architectural and Structural Metals Manufacturing (NAICS Code 332300);
• Art Dealers (NAICS Code 453920);
• Artificial and Synthetic Fibers and Filaments Manufacturing (NAICS Code 325220);
• Audio and Video Equipment Manufacturing (NAICS Code 334300);
• Automobile Dealers (NAICS Code 441110);
• Automotive Body, Paint and Interior Repair and Maintenance (NAICS Code 811121);
• Automotive Exhaust System Repair (NAICS Code 811112);
• Automotive Glass Replacement Shops (NAICS Code 811122);
• Automotive Oil Change and Lubrication Shops (NAICS Code 811191);
• Automotive Parts and Accessories Stores (NAICS Code 441310);
• Automotive Transmission Repair (NAICS Code 811113);
• Boiler, Tank, and Shipping Container Manufacturing (NAICS Code 332400);
• Books Printing (NAICS Code 323117);
• Broadwoven Fabric Mills (NAICS Code 313210);
• Car Washes (NAICS Code 811192);
• Coating, Engraving, Heat Treating, and Allied Activities (NAICS Code 332800);
• Commercial and Industrial Machinery and Equipment (except Automotive and Electronic) Repair and Maintenance (NAICS Code 811310);
• Commercial and Institutional Building Construction (NAICS Code 236220);
• Commercial and Service Industry Machinery Manufacturing (NAICS Code 333300);
• Commercial Printing (except Screen and Books) (NAICS Code 323111);
• Commercial Screen Printing (NAICS Code 323113); Start Printed Page 51135
• Commercial, Industrial and Institutional Electric Lighting Fixture Manufacturing (NAICS Code 335122);
• Communication Equipment Repair and Maintenance (NAICS Code 811213);
• Communications Equipment Manufacturing (NAICS Code 334200);
• Computer and Office Machine Repair and Maintenance (NAICS Code 811212);
• Computer and Peripheral Equipment Manufacturing (NAICS Code 334100);
• Computer Terminal and Other Computer Peripheral Equipment Manufacturing (NAICS Code 334118);
• Consumer Electronics Repair and Maintenance (NAICS Code 811211);
• Cut Stock, Resawing Lumber, and Planing (NAICS Code 321912);
• Cutlery and Handtool Manufacturing (NAICS Code 332200);
• Dental Equipment and Supplies Manufacturing (NAICS Code 339114);
• Drywall and Insulation Contractors (NAICS Code 238310);
• Electric Lighting Equipment Manufacturing (NAICS Code 335100);
• Electrical Contractors and Other Wiring Installation Contractors (NAICS Code 238210);
• Electrical Equipment Manufacturing (NAICS Code 335300);
• Engine, Turbine, and Power Transmission Equipment Manufacturing (NAICS Code 333600);
• Executive Offices (NAICS Code 921110);
• Fabric Coating Mills (NAICS Code 313320);
• Facilities Support Services (NAICS Code 561200);
• Flooring Contractors (NAICS Code 238330);
• Fluid Power Cylinder and Actuator Manufacturing (NAICS Code 333995);
• Footwear Manufacturing (NAICS Code 316210);
• Forging and Stamping (NAICS Code 332100);
• Foundries (NAICS Code 331500);
• Framing Contractors (NAICS Code 238130);
• Furniture Stores (NAICS Code 442110);
• General Automotive Repair (NAICS Code 811111);
• Glass and Glazing Contractors (NAICS Code 238150);
• Hardware Manufacturing (NAICS Code 332500);
• Hazardous Waste Treatment and Disposal (NAICS Code 562211);
• Highway, Street, and Bridge Construction (NAICS Code 237310);
• Home and Garden Equipment Repair and Maintenance (NAICS Code 811411);
• Home Furnishing Merchant Wholesalers (NAICS Code 423220);
• Household Appliance Manufacturing (NAICS Code 335200);
• Independent Artists, Writers and Performers (NAICS Code 711510);
• Industrial Building Construction (NAICS Code 236210);
• Industrial Gas Manufacturing (NAICS Code 325120);
• Industrial Machinery Manufacturing (NAICS Code 333200);
• Investment Advice (NAICS Code 523930);
• Iron and Steel Mills and Ferroalloy Manufacturing (NAICS Code 331100);
• Lessors of Other Real Estate Property (NAICS Code 531190);
• Machine Shops; Turned Product; and Screw, Nut, and Bolt Manufacturing (NAICS Code 332700);
• Manufacturing and Reproducing Magnetic and Optical Media (NAICS Code 334600);
• Masonry Contractors (NAICS Code 238140);
• Materials Recovery Facilities (NAICS Code 562920);
• Medical Equipment and Supplies Manufacturing (NAICS Code 339100);
• Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers (NAICS Code 332812);
• Metalworking Machinery Manufacturing (NAICS Code 333500);
• Miscellaneous Intermediation (NAICS Code 523910);
• Motor Vehicle Body and Trailer Manufacturing (NAICS Code 336200);
• Motor Vehicle Manufacturing (NAICS Code 336100);
• Motor Vehicle Parts Manufacturing (NAICS Code 336300);
• Motor Vehicle Supplies and New Parts Merchant Wholesalers (NAICS Code 423120);
• Motor Vehicle Towing (NAICS Code 488410);
• Museums (NAICS Code 712110);
• Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (NAICS Code 334500);
• New Car Dealers (NAICS Code 441110);
• New Housing For-Sale Builders (NAICS Code 236117);
• New Multifamily Housing Construction (except For-Sale Builders) (NAICS Code 236116);
• New Single-family Housing Construction (Except For-Sale Builders) (NAICS Code 236115);
• Nitrogenous Fertilizer Manufacturing (NAICS Code 325311);
• Nonferrous Metal (except Aluminum) Production and Processing (NAICS Code 331400);
• Non-upholstered Wood Household Furniture Manufacturing (NAICS Code 337122);
• Office Administrative Services (NAICS Code 561110);
• Oil and Gas Pipeline and Related Structures Construction (NAICS Code 237120);
• Other Aircraft Part and Auxiliary Equipment Manufacturing7 (NAICS Code 336413);
• Other Automotive Mechanical and Electrical Repair and Maintenance (NAICS Code 811118);
• Other Basic Inorganic Chemical Manufacturing (NAICS Code 325180);
• Other Building Equipment Contractors (NAICS Code 238290);
• Other Chemical and Allied Products Merchant Wholesalers (NAICS Code 424690);
• Other Concrete Product Manufacturing (NAICS Code 327390);
• Other Construction Material Merchant Wholesalers (NAICS Code 423390);
• Other Electrical Equipment and Component Manufacturing (NAICS Code 335900);
• Other Electronic and Precision Equipment Repair and Maintenance (NAICS Code 811219);
• Other Equipment and Component Manufacturing (NAICS Code 335900);
• Other Fabricated Metal Product Manufacturing (NAICS Code 332900);
• Other Foundation, Structure, and Building Exterior Contractors (NAICS Code 238190);
• Other General Purpose Machinery Manufacturing (NAICS Code 333900);
• Other Heavy and Civil Engineering Construction (NAICS Code 237990);
• Other Industrial Machinery Manufacturing (NAICS Code 333249);
• Other Measuring and Controlling Device Manufacturing (NAICS Code 334519);
• Other Nonhazardous Waste Treatment and Disposal (NAICS Code 562219);
• Other Personal and Household Goods Repair and Maintenance (NAICS Code 811490);
• Other Professional Equipment and Supplies Merchant Wholesalers (NAICS Code 423490);
• Paint and Coating Manufacturing (NAICS Code 325510);
• Painting and Wall Covering Contractors (NAICS Code 238320);
• Paper Bag and Coated and Treated Paper Manufacturing (NAICS Code 322220);
• Pesticide and Other Agricultural Chemical Manufacturing (NAICS Code 325320);
• Petrochemical Manufacturing (NAICS Code 325110);
• Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) (NAICS Code 424720); Start Printed Page 51136
• Petroleum Bulk Stations and Terminals (NAICS Code 424710);
• Petroleum Lubricating Oil and Grease Manufacturing (NAICS Code 324191);
• Petroleum Refineries (NAICS Code 324110);
• Plastics Material and Resin Manufacturing (NAICS Code 325211);
• Plumbing, Heating, and Air-Conditioning Contractors (NAICS Code 238220);
• Polish and Other Sanitation Good Manufacturing (NAICS Code 325612);
• Poured Concrete Foundation and Structure Contractors (NAICS Code 238110);
• Power and Communication Line and Related Structures Construction (NAICS Code 237130);
• Railroad Rolling Stock Manufacturing (NAICS Code 336500);
• Residential Remodelers (NAICS Code 236118);
• Reupholstery and Furniture Repair (NAICS Code 811420);
• Roofing Contractors (NAICS Code 238160);
• Roofing, Siding, and Insulation Material Merchant Wholesalers (NAICS Code 423330);
• Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing (NAICS Code 334511);
• Semiconductor and Other Electronic Component Manufacturing (NAICS Code 334400);
• Semiconductor and Related Device Manufacturing (NAICS Code 334413);
• Semiconductor Machinery Manufacturing (NAICS Code 333242);
• Service Establishment Equipment and Supplies Merchant Wholesalers (NAICS Code 423850);
• Ship Building and Repairing (NAICS Code 336611);
• Siding Contractors (NAICS Code 238170);
• Sign Manufacturing (NAICS Code 339950);
• Site Preparation Contractors (NAICS Code 238910);
• Soap and Other Detergent Manufacturing (NAICS Code 325611);
• Solid Waste Combustors and Incinerators (NAICS Code 562213);
• Solid Waste Landfill (NAICS Code 562212);
• Sporting Goods Stores (NAICS Code 451110);
• Spring and Wire Product Manufacturing (NAICS Code 332600);
• Steel Product Manufacturing from Purchased Steel (NAICS Code 331200);
• Storage Battery Manufacturing (NAICS Code 335911);
• Structural Steel and Precast Concrete Contractors (NAICS Code 238120);
• Support Activities for Printing (NAICS Code 323120);
• Testing Laboratories (NAICS Code 541380);
• Urethane and Other Foam Product (except Polystyrene) Manufacturing (NAICS Code 326150);
• Used Car Dealers (NAICS Code 441120);
• Used Merchandise Stores (NAICS Code 453310);
• Ventilation, Heating, Air-Conditioning, and Commercial Refrigeration Equipment Manufacturing (NAICS Code 333400);
• Water and Sewer Line and Related Structures Construction (NAICS Code 237110); and
• Wood Kitchen Cabinet and Countertop Manufacturing (NAICS Code 337110).

This action may also affect certain entities through pre-existing import certification and export notification requirements under TSCA ( https://www.epa.gov/​tsca-import-export-requirements ). Persons who import any chemical substance governed by a final TSCA section 6(a) rule are subject to the TSCA section 13 ( 15 U.S.C. 2612 ) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28 ). Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B .

In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) ( 15 U.S.C. 2611(b) ), and must comply with the export notification requirements in 40 CFR part 707, subpart D .

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT .

Under TSCA section 6(a) ( 15 U.S.C. 2605(a) ), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk.

Pursuant to TSCA section 6(b), EPA determined that NMP presents an unreasonable risk of injury to health, without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS) identified as relevant to the 2020 Risk Evaluation for NMP by EPA, under the conditions of use (Refs. 1, 2). The term “conditions of use” is defined at TSCA section 3(4) ( 15 U.S.C. 2602(4) ) to mean the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A detailed description of the conditions of use that EPA evaluated in reaching its determination that NMP presents an unreasonable risk is in Unit III.B.1. EPA notes that all TSCA conditions of use of NMP are subject to this proposal. Accordingly, to address the unreasonable risk, EPA is proposing, under TSCA section 6(a), to:

(i) Prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP for five occupational conditions of use, as described in Unit IV.A.1.;

(ii) Require container size limits and labeling requirements for the manufacture (including import), processing, and distribution in commerce of NMP for seven consumer uses, as described in Unit IV.A.2.;

(iii) Require prescriptive controls, including concentration limits and personal protective equipment (PPE) for seven occupational conditions of use, as described in Unit IV.A.4.;

(iv) Require strict workplace controls, including an NMP WCPP, that would include requirements to prevent direct dermal contact with NMP, for all other occupational conditions of use, as described in Unit IV.A.3, including the commercial use of paints and coatings and paint, coating, and adhesive removers containing high concentrations of NMP in uses essential to the missions of the Department of Defense (DOD) and National Aeronautics and Space Administration (NASA);

(v) Require a concentration limit on NMP for the import, processing, and distribution in commerce of one consumer use, as described in Unit IV.A.5.;

(vi) Establish recordkeeping and downstream notification requirements, as described in Unit IV.A.7. Start Printed Page 51137

In addition, EPA is proposing to amend the general provisions of 40 CFR part 751, subpart A , to define the following terms so that these definitions may be commonly applied to this and other rules under TSCA section 6 that would be codified under 40 CFR part 751 : “Direct dermal contact,” “Exposure group,” and “Restricted area.” EPA seeks public comment on all aspects of this proposal. These definitions may be codified in another rule under 40 CFR part 751 prior to the publication of the final rulemaking for NMP. EPA seeks public comment on all aspects of this proposal.

Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk.” NMP was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020 (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in December 2022 (Ref. 3), determining that NMP, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that NMP no longer presents such risk. The unreasonable risk is described in Unit III.B.2. and the conditions of use EPA evaluated in reaching its conclusion that NMP presents unreasonable risk are described in Unit III.B.1.

NMP's hazards are well established. EPA's 2020 Risk Evaluation for NMP considered the hazards associated with exposure to NMP and determined that NMP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to NMP. Some of the risks of adverse effects from NMP exposure may be acute and experienced for only a short duration. However, certain short duration exposures can result in irreversible impacts—such as post-implantation fetal loss. Other risks may be chronic and result in long-term impacts that are also irreversible. As described in the 2020 Risk Evaluation for NMP, post-implantation fetal loss and reduced fertility and fecundity are the most representative adverse effects of NMP exposure (Ref. 1). Other significant adverse effects include liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization. EPA is proposing requirements so that NMP would no longer present unreasonable risk to human health, including PESS.

EPA is proposing to ban several occupational conditions of use of NMP, such as processing of NMP for incorporation into articles in lubricants and as a lubricant additive in machinery manufacturing, and industrial and commercial use of NMP in anti-freeze and de-icing products, automotive care products, and lubricants, and greases. For some of these conditions of use, EPA has not identified any current use of NMP ( e.g., in antifreeze, de-icing products, and lubricants); for most others, EPA has identified possible alternatives in the alternative assessment (Ref. 4). The uses that EPA proposes to prohibit comprise an estimated 18% of the current production volume of NMP. EPA is not proposing a complete ban on NMP. EPA determined that most consumer uses do not contribute to the unreasonable risk for NMP, largely due to the generally low concentration of NMP in consumer products and the infrequent use by consumers of those products (Ref. 1). However, the commercial use of the same types of products does contribute to the unreasonable risk because they generally contain higher concentrations of NMP and are used more frequently in commercial settings. Therefore, EPA is proposing to regulate these consumer products in a manner that will help ensure that these products are not diverted to commercial use, as is further described in Unit V.A.1.a.

This rulemaking also proposes to allow certain uses of NMP to continue, provided that sufficient worker protection measures and stringent controls are in place to prevent direct dermal contact to NMP and address the unreasonable risk driven by direct dermal contact for most of the occupational conditions of use. For many of the occupational conditions of use, EPA is proposing strict workplace controls under a WCPP. These conditions of use include the manufacturing of NMP, processing NMP as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative processing and use of NMP as a laboratory chemical. These also include the use of NMP in the manufacture of specialized electronics, such as magnet wire, semiconductors, and lithium-ion batteries used in a wide variety of applications including aerospace vehicles or electronic devices, or the use of NMP in petrochemical manufacturing as a processing aid in lubricant extraction. These conditions of use comprise an estimated 44% of the current production volume of NMP. In many of these industries, EPA expects that facilities will already have in place the types of exposure controls that EPA proposes to require. For example, EPA understands that most workplaces using NMP in semiconductor manufacturing already have stringent controls in place that reduce workplace exposures. For other conditions of use, because EPA does not believe or have specific information demonstrating that direct dermal contact can reasonably be prevented, and expects the application method, such as spray application, to increase the contribution to the unreasonable risk from inhalation exposure, EPA is proposing limits on the weight fraction of NMP in formulated products in combination with personal protective equipment (PPE) and other workplace controls to address the unreasonable risk. These conditions of use include the commercial use of NMP in certain formulations, including various coatings, such as paint, adhesives, sealants, inks, and soldering materials in a variety of applications and their associated removers. These conditions of use comprise an estimated 37% of the current production volume of NMP. EPA is also proposing a limit on the weight fraction of NMP in one consumer use of NMP to mitigate the unreasonable risk to consumers from the use of NMP in adhesives and sealants.

As noted earlier, the conditions of use that EPA is proposing to ban comprise an estimated 18% of the current production volume of NMP. Of the conditions of use that would not be prohibited, EPA expects the production volume for certain conditions of use to decline over time. For example, EPA expects the industrial and commercial use of NMP in paints and coatings to decline over time as formulators either reformulate to a lower concentration of NMP or away from NMP, especially as the requirement to meet strict workplace controls could result in a transition in many workplaces away from NMP to other chemical alternatives, such as those identified in the alternative analysis (Ref. 4). For other conditions of use, EPA expects the production volume to increase over time. For example, EPA expects the industrial and commercial use of NMP in the manufacture of specialized electronics, including semiconductors and lithium ion Start Printed Page 51138 batteries, to increase as the global demand for electronic devices increases.

EPA recognizes that some occupational conditions of use are important for national security applications or for other critical or essential uses for which no technically or economically feasible safer alternatives have been identified. While EPA has identified that prescriptive controls—including limiting the weight fraction of NMP in paints, coatings, or paint and coating removers or adhesive removers—could address the unreasonable risk, EPA also understands that DOD and NASA use high concentrations of NMP in uses critical to their missions. In the context of DOD and NASA use, EPA expects that the exposure controls that could be put into place under the WCPP could address the unreasonable risk. As a result, EPA is proposing that the WCPP could be used for specific DOD and NASA uses of high concentrations of NMP from the proposed prescriptive workplace controls for industrial and commercial uses of NMP in paints and coatings and for industrial and commercial uses of NMP in paint, coating, and adhesive removers. More information about these conditions of use, and their continuance to ensure aviation, including space vehicles, and military readiness is in Unit V.A.1.c.iii. EPA emphasizes that information available to EPA does not indicate that commercial users other than DOD or NASA use such high concentrations of NMP, or that they have a need for similar paints or coatings, or paint, coating, or adhesive removal. More information and EPA's requests for comment on these conditions of use is in Unit V.A.1.c.iii.

The 2020 Risk Evaluation for NMP assessed the risk of injury to health from exposure to NMP from the combination of several routes of exposure, including dermal, inhalation, and vapor through skin intrusion. The 2020 Risk Evaluation for NMP also compared the relative exposures from these pathways with and without direct liquid contact. Table 4-54 in the 2020 Risk Evaluation shows the calculated results, which show that for most, but not all conditions of use that 99-100% of exposure to NMP is due to dermal contact with liquid. EPA identified unreasonable risk for NMP predominately due to the dermal exposure pathway, as discussed in Units III.B.2. Thus, EPA has not identified and is not proposing to set an Existing Chemical Exposure Limit (ECEL) for NMP because such a level would only account for risk resulting from the inhalation pathway. Addressing inhalation risks alone would not mitigate the unreasonable risk from NMP. EPA's consideration of an ECEL for NMP is described further in in Unit V.A.3.

EPA has prepared an Economic Analysis of the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket (Ref. 5). As described in more detail in the Economic Analysis (Ref. 5) and in Units VI.D. and X.D., EPA's analysis of the incremental monetized costs of this proposed rule is estimated to be $396 million annualized over 20 years at a 3% discount rate and $397 million annualized over 20 years at a 7% discount rate. These costs take into consideration compliance with implementation of a WCPP, which would include dermal controls to prevent direct dermal contact, applicable PPE requirements including as part of prescriptive controls requirements, and costs for reformulation and container size restrictions of numerous products. Cost estimates by use category are provided in the Economic Analysis Table 7-36 (Ref. 5). The most notable unquantified costs include possible costs from prohibition of use of NMP for certain conditions of use as changes in labor time or differences in efficacy for a specific firm's use are unknown to EPA. Unquantified costs and other uncertainties in the cost analyses are described more fully in section 7.10 of the Economic Analysis (Ref. 5).

The actions proposed in this rulemaking are expected to achieve significant health benefits for the American public, most of which, while tangible and significant, cannot at present be monetized primarily due to a lack of applicable dose-response functions, which are the relationships between exposures and any incremental adverse effects. This issue is not unique to EPA and is a government-wide issue for many noncancer endpoints. EPA is requesting public comment on methodologies for developing noncancer human dose-response curves and valuation methods for the health endpoints identified for NMP in the Risk Evaluation, specifically willingness to pay studies. Non-monetized benefits include risk reduction of developmental and reproductive effects, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization. (Ref. 5) While the benefits to human health associated with risk reduction of developmental and reproductive effects, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization cannot be monetized at present, reductions in occurrence of these conditions clearly have monetary value to society. The importance of these reductions in occurrence should not be diminished or dismissed simply because EPA currently lacks the analytical tools to precisely monetize the positive societal impacts of this proposed regulation.

Human health risks were found at both chronic and acute exposure levels. Rather than accumulating over a lifetime, risks were found for workers exposed to NMP during the course of a workweek, or five days. The 2020 Risk Evaluation assumed one day of exposure for acute scenarios, and five days of exposure per week for chronic scenarios. Blood concentrations of NMP are expected to be eliminated over the course of a weekend with no exposure to NMP.

The 2020 Risk Evaluation for NMP identified developmental effects as the most representative adverse effects of acute NMP exposure. EPA specified post-implantation loss as the critical effect of acute exposures over the course of a day. Post-implantation loss also referred to as fetal death or fetal mortality includes miscarriage, spontaneous abortion, or stillbirth, depending on when in the pregnancy it occurs. Fetal death may result from a single maternal exposure to NMP at a developmentally critical period (Ref. 1). Exposure to NMP during a single day (over 8 hours) was found to present risks of fetal death; further information is in section 3.2.3 of the 2020 Risk Evaluation (Ref. 1). While there are some estimates of the cost of medical treatment for miscarriage and stillbirth, there are no willingness-to-pay estimates of the value of reduced risk of fetal death. It is very likely that willingness-to-pay would be much higher than the costs of medical treatment alone; further information is in section 8.5.1 of the Economic Analysis (Ref. 5). The impacts of fetal death, including miscarriage or stillbirth, include mental health impacts, such as depression and anxiety on the woman experiencing the death of a fetus, and can also impact partners and spouses (Ref. 5). Mental health research has consistently identified both miscarriage (defined as fetal death occurring before the 20th week of gestation) and stillbirth (defined as fetal death occurring after the 20th week of gestation) as a significant emotional burden exhibited as anxiety and depression that can persist; research suggests women and men feel effects for Start Printed Page 51139 more than a year, women can feel effects nearly three years following the event of fetal death and after the birth of a healthy child, which emphasizes effects can persist significantly longer beyond the event (Ref. 5).

The 2020 Risk Evaluation for NMP identified reproductive effects as the most representative adverse effects of chronic NMP exposure. Specifically, EPA identified reduced male fertility as the critical effect resulting from repeated exposures during the work week (Ref. 1). In addition to this critical effect, decreased female fecundity is a health effect of concern. While impacts from NMP exposure on fertility and fecundity cannot be quantified at this time with available data, for couples seeking treatment for infertility, costs of such treatment are often significant both financially and emotionally. The most comprehensive and appropriate value for benefit-cost analysis is willingness to pay. There are few studies for the reduced risk of infertility, but a recent study estimates a willingness to pay of $102,000 per statistical case of infertility avoided (Ref. 5). EPA also identified low-birth weight resulting from repeated exposures to women of child-bearing age as another health effect of concern. It is not known if there is a window of exposure that may pose greater risks to the fetus; therefore, any repeated exposure to NMP could increase risks to the fetus for reproductive effects. Even when maternal exposure ceased, the decreased fetal body weight was found to be a persistent adverse effect (Ref. 1); consequently, a relatively brief period of maternal repeated exposure to NMP in typical workplace activities can cause fetal weight decreases. Low birth weight can have significant impacts on childhood development and the incidence of future diseases; reduced birth weight can cause serious health problems for some children, as well as long-term impacts on their lives as adults (Ref. 5).

EPA identified additional unquantified benefits from this rulemaking. While the risk evaluation does not describe kidney toxicity as resulting in specific diseases, for the purposes of characterizing potential benefits, the most relevant outcomes are acute kidney failure and chronic kidney disease. Signs and symptoms of acute kidney failure include decreased urine output, although occasionally urine output remains normal; fluid retention, causing swelling in the legs, ankles or feet; drowsiness; shortness of breath; fatigue; confusion; nausea; seizures or coma in severe cases; and chest pain or pressure. Sometimes acute kidney failure causes no signs or symptoms and is detected through lab tests done for another reason.

Chronic kidney disease is associated with many of these same symptoms over a longer period of time. Chronic kidney disease is irreversible and usually progressive, though it can be managed to some extent. In its earliest stages, chronic kidney disease may have little impact on quality of life and require minimal medical care. As chronic kidney disease progresses, however, the likelihood of symptoms increases and quality of life and ability to work and perform daily activities can be affected. When the kidney is damaged to the point that it no longer functions, dialysis or kidney transplant is necessary. This is known as kidney failure or end-stage renal disease. Kidney dialysis and kidney transplantation are expensive and incur long-term health costs with the potential for a significant decrease in a person's quality of life (Ref. 5).

There are potential increased health risks for liver toxicity for workers exposed to NMP. The most commonly known causes of this disease burden are attributable to alcoholism and viral infections, such as hepatitis A, B, and C. These known risk factors of hepatitis infection may result in increased vulnerability of individuals exposed to organic chemicals such as NMP. Liver toxicity can lead to jaundice, weakness, fatigue, weight loss, nausea, vomiting, abdominal pain, impaired metabolism, and liver disease (notably fatty liver disease). Given the evidence in the risk evaluation it is reasonable to conclude that reductions in chronic exposures to NMP may produce benefits from reduced incidence of fatty liver disease. While the magnitude of these benefits cannot be quantified, information on the costs of fatty liver disease provides some perspective on whether those benefits might be significant (Ref. 5).

This proposed rule applies to NMP (CASRN 872-50-4) and is intended to address the unreasonable risk of injury to health that EPA has identified for NMP (Refs. 1, 2). NMP is a colorless liquid that is produced in and imported into the United States. NMP is manufactured, processed, distributed, used, and disposed of as part of many industrial, commercial, and consumer conditions of use. According to data submitted for the EPA's 2016 Chemical Data Reporting rule (CDR), the total aggregate annual production volume of NMP in the United States was over 160 million pounds, and, according to data submitted for the 2020 CDR, the total aggregate annual production volume of NMP ranged from 100-250 million pounds between 2016 and 2019 (Ref. 6). As outlined in further detail in Unit III.B.1., NMP is used as a processing reactant or intermediate or incorporated into a formulation, as a solvent in the production of electronics and petroleum products, polymers, and other specialty chemicals; and in a variety of commercial and consumer applications such as a paint and coating additive, in adhesives and sealants, in laboratory chemicals, and a solvent for cleaning or degreasing.

Because of its adverse health effects, NMP is subject to Federal laws and regulations in the United States and is also subject to regulation by some states and other countries. A summary of EPA regulations pertaining to NMP, as well other Federal, state, and international regulations, is in the docket (Refs. 7, 1).

Although EPA must consider and factor in, to the extent practicable, certain non-risk factors as part of TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still ensure that the selected regulatory requirements apply “to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk.” This requirement to eliminate unreasonable risk is distinguishable from approaches mandated by some other laws, including the Occupational Safety and Health Act (OSH Act), which includes both significant risk and feasibility (technical and economic) considerations in the setting of standards.

Congress intended for EPA to consider occupational risks from chemicals it evaluates under TSCA, among other potential exposures, as relevant and appropriate. As noted previously, TSCA section 6(b) requires EPA to evaluate risks to PESS identified as relevant by the Administrator. TSCA section 3(12) defines the term “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, Start Printed Page 51140 pregnant women, workers, or the elderly.”

The OSH Act similarly requires OSHA to evaluate risk specific to workers prior to promulgating new or revised standards and requires OSHA standards to substantially reduce significant risk to the extent feasible, even if workers are exposed over a full working lifetime. See 29 U.S.C. 655(b)(5) ; Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980) (plurality opinion).

Thus, the standards for chemical hazards that OSHA promulgates under the OSH Act share a broadly similar purpose with the standards that EPA promulgates under TSCA section 6(a). The control measures OSHA and EPA require to satisfy the objectives of their respective statutes may also, in many circumstances, overlap or coincide. However, as this section outlines, there are important differences between EPA's and OSHA's regulatory approaches and jurisdiction, and EPA considers these differences when deciding whether and how to account for OSHA requirements (Ref. 7) when evaluating and addressing potential unreasonable risk to workers so that compliance requirements are clearly explained to the regulated community.

OSHA's mission is to ensure that employees work in safe and healthful conditions. The OSH Act establishes requirements that each employer comply with the General Duty Clause of the Act ( 29 U.S.C. 654(a) ), as well as with occupational safety and health standards issued under the Act.

The General Duty Clause of the OSH Act requires employers to keep their workplaces free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. The General Duty Clause is cast in general terms, and does not establish specific requirements like exposure limits, PPE, or other specific protective measures that EPA could potentially consider when developing its risk evaluations or risk management requirements. OSHA, under limited circumstances, has cited the General Duty Clause for regulating exposure to chemicals. To prove a violation of the General Duty Clause, OSHA must prove employer or industry recognition of the hazard, the hazard was causing or likely to cause death or serious physical harm, and a feasible method to eliminate or materially reduce the hazard was available. Because of the heavy evidentiary burden on OSHA to establish violations of the General Duty Clause, it is not frequently used to cite employers for employee exposure to chemical hazards.

OSHA standards are issued pursuant to the OSH Act and are found in title 29 of the Code of Federal Regulations . There are separate standards for general industry, laboratories, construction, maritime and agriculture sectors, and general standards applicable to a number of sectors ( e.g., OSHA's Respiratory Protection standard). OSHA has numerous standards that apply to employers who operate chemical manufacturing and processing facilities, as well as to downstream employers whose employees may be occupationally exposed to hazardous chemicals.

OSHA sets legally enforceable limits on the airborne concentrations of hazardous chemicals, referred to as Permissible Exposure Limits (PELs), established for employers to protect their workers against the health effects of exposure to hazardous substances ( 29 CFR part 1910, subpart Z , part 1915, subpart Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, OSHA was permitted an initial 2-year window after the passage of the Act to adopt “any national consensus standard and any established Federal standard.” 29 U.S.C. 655(a) . OSHA used this authority in 1971 to establish PELs that were adopted from Federal health standards originally set by the Department of Labor through the Walsh-Healy Act, in which approximately 400 occupational exposure limits (OELs) were selected based on the American Conference of Governmental Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about 25 exposure limits recommended by the American Standards Association (now called the American National Standards Institute or ANSI) were adopted as PELs.

Following the 2-year window provided under section 6(a) of the OSH Act for adoption of national consensus and existing Federal standards, OSHA has issued health standards following the requirements in section 6(b) of the Act. OSHA has established approximately 30 PELs under section 6(b)(5) as part of comprehensive substance-specific standards that include additional requirements for protective measures such as use of PPE, establishment of regulated areas, exposure assessment, hygiene facilities, medical surveillance, and training. These ancillary provisions in substance-specific OSHA standards further mitigate residual risk that could be present due to exposure at the PEL.

Further, many of OSHA's chemical-specific permissible exposure limits were adopted in the 1970s and have not been updated since they were established. Additionally, TSCA risk evaluations are subject to statutory science standards, an explicit requirement to consider risks to potentially exposed or susceptible subpopulations, and a prohibition on considering costs and other non-risk factors when determining whether a chemical presents an unreasonable risk that warrants regulatory actions—all requirements that do not apply to development of OSHA regulations. As such, EPA may find unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. There is also no established OSHA standard or PEL for NMP. In addition, health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only to the extent that it is technologically and economically feasible. OSHA's legal requirement to demonstrate that its section 6(b)(5) standards are technologically and economically feasible at the time they are promulgated often precludes OSHA from imposing exposure control requirements sufficient to ensure that the chemical substance no longer presents a significant risk to workers.

While it is possible in some cases that the OSHA standards for some chemicals reviewed under TSCA will eliminate unreasonable risk, based on EPA's experience thus far in conducting occupational risk assessments under TSCA, EPA believes that OSHA chemical standards would in general be unlikely to address unreasonable risk to workers within the meaning of TSCA, since TSCA section 6(b) unreasonable risk determinations may account for unreasonable risk to more sensitive endpoints and working populations than OSHA's risk evaluations typically contemplate and EPA is obligated to apply TSCA section 6(a) risk management requirements to the extent necessary so that the unreasonable risk is no longer presented. Because the requirements and application of TSCA and OSHA regulatory analyses differ, it is necessary for EPA to conduct risk evaluations and, where it finds unreasonable risk to workers, develop risk management requirements for chemical substances that OSHA also regulates, and it is expected that EPA's findings and requirements may sometimes diverge from OSHA's. However, it is also appropriate that EPA consider the chemical standards that OSHA has already developed to limit Start Printed Page 51141 the compliance burden to employers by aligning management approaches required by the agencies, where alignment will adequately address unreasonable risk to workers. The following unit discusses EPA's consideration of OSHA standards in its risk evaluation and management strategies under TSCA.

When characterizing the risk during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where no mitigation measures are assumed to be in place for the purpose of determining unreasonable risk (see Unit II.C.2.a.). However, there are some cases where scenarios may reflect certain mitigation measures, such as in instances where exposure estimates are based on monitoring data at facilities that have existing engineering controls in place. For example, in the 2020 Risk Evaluation for NMP, EPA used data received from the Semiconductor Industry Association to develop the occupational exposure scenario used for several conditions of use of NMP in semiconductor manufacturing. The data included full-shift personal breathing zone sampling results at semiconductor fabrication facilities during container handling of both small containers and drums, by workers inside the fabrication rooms, maintenance workers, workers unloading trucks containing virgin NMP, and workers loading trucks with waste NMP (Ref. 1). In addition, EPA believes it may be appropriate to also evaluate the levels of risk present in scenarios considering applicable OSHA requirements as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. EPA may evaluate risk under scenarios that consider industry or sector best practices for industrial hygiene that are clearly articulated to the Agency when doing so serves to inform its risk management efforts. Characterizing risks using scenarios that reflect different levels of mitigation can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address any unreasonable risk identified (see Unit II.C.2.b. and Unit II.C.3.).

When making unreasonable risk determinations as part of TSCA risk evaluations, EPA cannot assume as a general matter that all workers are always equipped with and appropriately using sufficient PPE, although EPA does not question the veracity of public comments received on the 2020 Risk Evaluation or 2022 revised risk determination for NMP regarding the occupational safety practices followed by industry respondents. When characterizing the risk to human health from occupational exposures during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where PPE is not assumed to be used by workers. This approach of not assuming PPE use by workers considers the risk to PESS (workers and occupational non-users (ONUs)) who may not be covered by OSHA standards, such as self-employed individuals and state and local government workers who are not covered by a State Plan. Mitigation scenarios included in the EPA risk evaluation ( e.g., scenarios considering use of PPE) likely represent current practice in many facilities where companies effectively address worker and bystander safety requirements. However, the Agency cannot assume that all facilities across all uses of the chemical substance will have adopted these practices for the purposes of making the TSCA risk determination.

Therefore, EPA makes its determinations of unreasonable risk based on scenarios that do not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on such scenarios should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and state and local government workers who are not covered by an OSHA State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements.

In addition to the scenarios described previously, EPA risk evaluations may characterize the levels of risk present in scenarios considering applicable OSHA requirements as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency to help inform risk management decisions.

When undertaking risk management actions, EPA: (1) Develops occupational risk mitigation measures to address any unreasonable risk identified by EPA, striving for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls, when those measures would address an unreasonable risk; and (2) Ensures that EPA requirements apply to all potentially exposed workers in accordance with TSCA requirements. Consistent with TSCA section 9(d), EPA consults and coordinates TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements. Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, broadly applicable regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply to them or not be sufficient to address the unreasonable risk.

EPA incorporated the considerations described earlier in this unit in the 2020 Risk Evaluation for NMP, the December 2022 revised unreasonable risk determination for NMP, and this rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for NMP, EPA presented risk estimates based on workers' exposures with and without respiratory protection and dermal PPE. EPA determined that even when respirators or expected dermal PPE are used by workers, most of the conditions of use evaluated presented an unreasonable risk. Additional consideration of OSHA standards in the revised unreasonable risk determination is discussed further in the Federal Register notice announcing that document (Ref. 3). In Units III.B.3. and Unit V., EPA outlines the importance of considering the hierarchy of controls utilized by the industrial hygiene community (hereafter referred to as “hierarchy of controls”) when Start Printed Page 51142 developing risk management actions in general, and specifically when determining if and how regulated entities may meet a risk-based exposure limit for NMP. The hierarchy of controls is a prioritization of exposure control strategies from most preferred to least preferred techniques. The control strategies include elimination of the hazard, substitution with a less hazardous substance, engineering controls, administrative controls such as training or exclusion zones with warning signs, and, finally, use of PPE (Ref. 8). Under the hierarchy of controls, the use of respirators and dermal PPE should only be considered after all other steps have been taken to reduce exposures. As discussed in Units IV.A. and V.A.1., EPA's risk management approach would not rely solely or primarily on the use of respirators and dermal PPE to address unreasonable risk to workers. Instead, EPA is proposing prohibitions for several conditions of use and a WCPP for most occupational conditions of use, including requirements to prevent direct dermal contact with NMP, which is the exposure route of most concern. The WCPP is discussed in full in Units IV.A.2. and V.A.1.b. and would require consideration of the hierarchy of controls before use of PPE. While EPA is proposing prescriptive controls for some occupational conditions of use, these do not solely rely on PPE for worker protection. Instead, EPA's proposed requirements would incorporate additional controls, such as concentration limits, to reduce exposures in alignment with the hierarchy of controls.

There is no chemical-specific OSHA standard or PEL for NMP. Similarly, EPA is not proposing an ECEL for NMP because the proportion of the exposure largely driving the unreasonable risk to workers is due to dermal contact with liquid NMP (Ref. 1) and an ECEL would only address risk from inhalation and vapor-through-skin (dermal exposure to vapor but not direct dermal contact with a liquid) exposures without accounting for the risk from direct dermal exposure. This is described in more detail in Unit V.A.3. In accordance with the approach described earlier in Unit II.C.3., EPA intends for this regulation to be as consistent as possible with the existing OSHA standards, with additional requirements as necessary to address the unreasonable risk.

EPA is aware of several occupational exposure limits (OELs) for NMP, including the ones described in this unit. The 2014 California Division of Occupational Safety and Health (Cal/OSHA) PEL for NMP is 1 ppm as an 8-hour TWA, along with a skin notation (California Code of Regulations, title 8, Section 5155). In the 2007 Occupational Health Hazard Risk Assessment Project for California, a range of occupational exposure limits (identified as a cREL in the document) for NMP were proposed, ranging from 0.4 to 5 ppm based on various options for duration adjustment and cumulative uncertainty factors (UFs). The cRELs were derived from decreased fetal and pup weight observed in Solomon et al, 1995 (Ref. 9). While this study was discussed in the 2020 Risk Evaluation for NMP, EPA did not select it for the point of departure (POD) derivation due to uncertainties about the actual doses achieved at the highest exposure and methodological inconsistencies with testing guidelines. Additionally, it was not the most sensitive chronic POD based on physiologically-based pharmacokinetic (PBPK) model internal dose metrics (Ref. 1).

The 8-hour TWA 2021 Occupational Alliance for Risk Science (OARS) Workplace Environmental Exposure Level (WEEL) for NMP is 15 ppm with a skin notation because of the ability of NMP to be absorbed through the skin, and the short-term TWA is 30 ppm (Ref. 10). The WEEL was based on PBPK modeling of maternal and developmental toxicity from Saillenfait et al., 2003, (Ref. 11) which was the basis of the acute point of departure in the 2020 Risk Evaluation for NMP. While OARS reviewed data from the Exxon, 1991 (Ref. 12) study for decreased male fertility that is the basis of EPA's chronic POD, those data were not included in the WEEL calculation.

The European Chemicals Agency (ECHA) restricts the use of NMP under the 2018 EU REACH restriction 71 with three conditions (Ref. 13). The conditions are: (1) NMP shall not be placed on the market as a substance on its own or in mixtures in concentrations greater than 0.3% after May 9, 2020, unless manufacturers, importers and downstream users have included chemical safety reports and Safety Data Sheets (SDSs) with Derived No Effect Levels (DNELs) relating to workers' exposures of 14.4 mg/m3 (equivalent to 3.5 ppm) for exposure by inhalation and 4.8 mg/kg/day for dermal exposure; (2) NMP shall not be manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0.3% after May 9, 2020 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in this paragraph; and (3) the restrictions specified in this paragraph shall apply from May 9, 2024, to placing on the market for use, or use, as a solvent or reactant in the process of coating wires.

The ECHA DNELs are based on systemic developmental effects in rats. The inhalation DNEL was based on no effects observed at the highest dose in Lee at al., 1987, (Ref. 14) and adjusted to a human equivalent concentration to result in the DNEL value. The dermal DNEL is 4.8 mg/kg-day based on a dermal no observed adverse effect level of 237 mg/kg for developmental toxicity in rats. Decreased live fetuses per litter, increased resorptions, and decreased fetal weights were observed at the high dose of 750 mg/kg. This DNEL is within the range of the estimated equivalent value based on PODs derived in the EPA risk evaluation or fenceline assessment (Refs. 15, 16).

In 2015, prior to amended TSCA, EPA published an NMP risk assessment of the occupational and consumer use of NMP in paint strippers, uses with high potential for exposure to consumers and workers (Ref. 17). In January 2017, EPA issued a proposed rule under TSCA section 6 ( 82 FR 7464 , January 17, 2017) (FRL-9958-57), to address risks that EPA had preliminarily identified for workers and consumers from use of methylene chloride and NMP in paint and coating removal. In March 2019, EPA issued a final rule under TSCA section 6 ( 84 FR 11420 , March 27, 2019) (FRL-9989-29), to address unreasonable risk from methylene chloride in consumer paint and coating removal. In January 2021, EPA withdrew the portion of the proposed rule under TSCA section 6 that included NMP ( 86 FR 3932 , January 15, 2021) (FRL-10018-67). In December 2016, EPA selected NMP as one of the first 10 chemicals for risk evaluation under TSCA section 6 ( 81 FR 91927 , December 19, 2016) (FRL-9956-47). EPA published the scope of the NMP risk evaluation in July 2017 ( 81 FR 31592 , July 7, 2017) (FRL-9963-57), and, after receiving public comments, published the problem formulation in June 2018 ( 83 FR 26998 , June 11, 2018) (FRL-9978-40). In December 2019, EPA published a draft risk evaluation ( 84 FR 60087 , November 7, 2019) (FRL-10003-71), and after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), published the 2020 Risk Evaluation for NMP in December Start Printed Page 51143 2020 in accordance with TSCA section 6(b) ( 85 FR 86558 , December 30, 2020) (FRL-10017-18). EPA subsequently issued a draft revised TSCA unreasonable risk determination for NMP ( 87 FR 39511 , July 1, 2022) (FRL-9943-01-OCSPP), and after public notice and receipt of comments, published a final revised Unreasonable Risk Determination for NMP ( 87 FR 77596 , December 19, 2022) (FRL-9943-02-OCSPP). The 2020 Risk Evaluation for NMP and supplemental materials are in docket EPA-HQ-OPPT-2019-0235, with the December 2022 final revised unreasonable risk determination and additional materials supporting the risk evaluation process in docket EPA-HQ-OPPT-2016-0743, on https://www.regulations.gov .

In the 2020 Risk Evaluation for NMP, EPA evaluated risks associated with 37 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal. Descriptions of these conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for NMP identified significant adverse health effects associated with exposure to NMP, including developmental effects from acute inhalation and dermal exposures, and reproductive effects from inhalation and dermal exposures to NMP. A further discussion of the hazards of NMP is in Unit III.B.2. The 2020 Risk Evaluation updated the hazard points of departure (POD) from the draft risk evaluation and 2015 risk assessment based on updated analyses performed in response to peer review comments. Updated quantitative analyses of additional studies and endpoints did not lead to a revised chronic POD, which remained at 183 hr-mg/L blood area-under-the curve (AUC), based on decreased male fertility. In contrast, updating the quantitative analyses of acute studies resulted in a revision of the acute POD from 216 mg/L to 437 mg/L peak blood concentration, which resulted in some changes to acute risk estimates, which impacted the unreasonable risk determination. Notably, with the updated POD, the consumer risk calculations resulted in identification of fewer conditions of use contributing to the unreasonable risk. EPA revised its determination regarding the contribution to unreasonable risk and did not identify the consumer use of NMP in paint and coating removers or the consumer use of NMP in cleaning and furniture care products as contributing to the unreasonable risk from NMP. This is discussed further in section 5.3 of the 2020 Risk Evaluation which presented an update to the findings from the 2015 risk assessment.

EPA has been revisiting specific aspects of its first ten TSCA existing chemical risk evaluations, including the 2020 Risk Evaluation for NMP, to ensure that the risk evaluations upon which risk management decisions are made, better align with TSCA's objective of protecting human health and the environment. For NMP, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for NMP and issued a final revised unreasonable risk determination in December 2022 (Ref. 2). EPA revised the risk determination for the 2020 Risk Evaluation for NMP pursuant to TSCA section 6(b) and consistent with Executive Order 13990 (entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 18, 19, and 20). The revisions consisted of making the risk determination based on the whole chemical substance instead of by individual conditions of use (which resulted in the revised risk determination superseding the prior “no unreasonable risk” determinations and withdrawing the associated TSCA section 6(i)(1) “no unreasonable risk” order) and clarifying that the risk determination does not reflect an assumption that all workers are always provided and appropriately wear PPE (Ref. 2). In determining whether NMP presents unreasonable risk under the conditions of use, EPA considered relevant risk-related factors, including, but not limited to: the effects of the chemical substance on health (including non-cancer risks) and human exposure to the substance under the conditions of use (including duration, magnitude and frequency of exposure); the effects of the chemical substance on the environment and environmental exposure under the conditions of use; the population exposed (including any PESS); the severity of hazard (including the nature of the hazard, the irreversibility of the hazard); and uncertainties. EPA also considered the Agency's confidence in the data used in the risk estimate. This included an evaluation of the strengths, limitations, and uncertainties associated with the information used to inform the risk estimate and the risk characterization. The peer-reviewed PBPK model used in the 2020 Risk Evaluation allowed EPA to estimate aggregate exposures from simultaneous dermal, inhalation, and vapor-through-skin exposures with relatively high confidence.

EPA determined that NMP presents an unreasonable risk of injury to health. Risks to workers and consumers contribute to the unreasonable risk from NMP. EPA did not identify risks of injury to the environment that contribute to the unreasonable risk from NMP. The NMP conditions of use that EPA evaluated and which contribute to EPA's determination that the chemical substance poses unreasonable risk to health are listed in the unreasonable risk determination (Ref. 2) and in Unit III.B.1.

The 2020 Risk Evaluation for NMP did not fully assess certain exposure pathways that were or could be regulated under another EPA-administered statute (see section 1.4.2 of the December 2020 Risk Evaluation for NMP) (Refs. 1, 2). For NMP, some exposure pathways received only a screening-level analysis. During problem formulation, EPA conducted a first-tier screening analysis for the ambient air pathway to near-field populations downwind from industrial and commercial facilities releasing NMP, which indicated low risk ( 83 FR 26998 , June 11, 2018) (FRL-9978-40). In the 2020 Risk Evaluation for NMP, EPA conducted a first-tier analysis to estimate NMP surface water concentrations and did not identify risks from incidental ingestion or dermal contact during swimming. This resulted in the ambient air and drinking water pathways for NMP not being fully assessed in the 2020 Risk Evaluation for NMP. In June 2021, EPA made a policy announcement on the path forward for TSCA chemical risk evaluations, indicating that EPA would, among other things, examine whether the exclusion of certain exposure pathways from the risk evaluations would lead to a failure to adequately protect fenceline communities (Ref. 3, 21). EPA then conducted a more robust assessment to identify whether there may be potential risks to people living near the fenceline of facilities releasing NMP.

To assess the potential risk to the general population in proximity to a facility releasing NMP, EPA developed the TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0, which was presented to the SACC in March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 22). This screening level approach, which EPA believes is effective in accurately assessing where fenceline Start Printed Page 51144 exposures are of no concern, is discussed in Unit VI.A.

Under TSCA section 6(a), if the Administrator determines, through a TSCA section 6(b) risk evaluation that the manufacture (including import), processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of such activities, presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more of the following requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk.

• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (TSCA section 6(a)(1)).
• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture for a particular use or above a specific concentration for a particular use (TSCA section 6(a)(2)).
• Limit the amount of the substance or mixture which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use specified (TSCA section 6(a)(2)).
• Require clear and adequate minimum warning and instructions with respect to the substance or mixture's use, distribution in commerce, or disposal, or any combination of those activities, to be marked on or accompanying the substance or mixture (TSCA section 6(a)(3)).
• Require manufacturers and processors of the substance or mixture to make and retain certain records or conduct certain monitoring or testing (TSCA section 6(a)(4)).
• Prohibit or otherwise regulate any manner or method of commercial use of the substance or mixture (TSCA section 6(a)(5)).
• Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture, or any article containing such substance or mixture, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (TSCA section 6(a)(6)).
• Direct manufacturers or processors of the substance or mixture to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance or mixture (TSCA section 6(a)(7)).

As described in Unit III.B.3., EPA analyzed how the TSCA section 6(a) requirements could be applied to address the unreasonable risk, so that NMP no longer presents such unreasonable risk. EPA's proposed regulatory action and alternative regulatory actions are described in Unit IV. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions and is providing notice that based on consideration of comments and any new information submitted to EPA during the comment period on this proposed rule, EPA may in the final rule modify elements of the proposed regulatory action. The public should understand that public comments could result in changes to elements of the proposed and alternative regulatory actions when this proposed rule is finalized. For example, elements such as timelines could be lengthened or shortened, concentration limits could be modified, or the WCPP could have provisions within the WCPP added or eliminated.

Under the authority of TSCA section 6(g), EPA may consider granting a time-limited exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use if EPA finds that: (1) The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (2) Compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or (3) The specific condition of use, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.

TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to consider and include a statement addressing certain factors, including the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. A description of all TSCA section 6 requirements considered in developing this proposed regulatory action is in Unit III.B.3., and Unit V. includes more information regarding EPA's consideration of alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use and in setting an appropriate transition period for such action, EPA consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as substitutes when the proposed prohibition or restriction takes effect. Unit V.B. includes more information regarding EPA's consideration of alternatives, and Unit VI. provides more information on EPA's considerations more broadly under TSCA section 6(c)(2).

EPA carried out required consultations as described in this unit and also considered impacts on children's environmental health as part of its approach to developing this TSCA section 6 regulatory action.

EPA conducted consultations and outreach in developing this proposed regulatory action. The Agency held a federalism consultation from July 22 to October 22, 2021, as part of this rulemaking process and pursuant to Executive Order 13132 . This included a background presentation on September 9, 2020, and a consultation meeting on July 22, 2021. During the consultation, EPA met with state and local officials early in the process of developing the proposed action to receive meaningful and timely input into its development (Ref. 23). During the consultation, participants and EPA discussed additional reporting requirements as a risk management tool to address the unreasonable risk, EPA's consideration of safer alternatives, and potential impacts to drinking water utilities (Ref. 23).

NMP is not manufactured (including imported) processed distributed in commerce or regulated by Tribal governments. However, EPA consulted with Tribal officials during the development of this proposed action (Ref. 24). The Agency held a Tribal consultation from May 21 to August 27, 2021, with meetings scheduled for June 14 and July 14, 2021. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for NMP, types of information that would be helpful to inform risk management, principles for transparency during the risk management process, and types of information EPA is seeking from Tribes (Ref. 24). EPA received no written comments as part of this consultation. Start Printed Page 51145

In addition to the formal consultations, EPA also conducted outreach to advocates of communities that might be subject to disproportionate risk from the exposures to NMP, such as minority populations, low-income populations, and indigenous peoples. EPA's Environmental Justice (EJ) consultation occurred from June 3 through August 27, 2021. On July 7 and July 13, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to and in compliance with Executive Orders 12898 and 14008. EPA received one written comment following the EJ meetings, in addition to oral comments provided during the consultation (Ref. 25). In general, commenters supported strong outreach to affected communities, encouraged EPA to follow the hierarchy of controls used by the industrial hygiene community, favored prohibitions, and noted the uncertainty, and in some cases the inadequacy, of PPE. Other commenters asked about the Agency's schedule for a proposed rule while reconsidering certain aspects of the 2020 Risk Evaluation. Additionally, commenters expressed concern that the adverse health impacts of NMP, particularly to pregnant women and children, and urged EPA to ban the use of NMP in paint and coating removers (Ref. 25). As required by section 609(b) of the Regulatory Flexibility Act (RFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives (SERs) that potentially would be subject to this proposed rule's requirements (Ref. 26). EPA met with SERs before and during Panel proceedings, on March 28 and May 24, 2023. Panel recommendations are in Unit X.C. and in the Initial Regulatory Flexibility Analysis (IRFA) (Ref. 27). The Panel report is in the docket (Ref. 26). Units X.C., X.E., X.F., and X.J. provide more information regarding the consultations.

In addition to the formal consultations described in Unit X., EPA held a webinar on February 24, 2021, providing an overview of the TSCA risk management process and the risk evaluation findings for NMP. EPA also presented on the risk evaluation and risk management under TSCA for NMP at a Small Business Administration Office of Advocacy small business roundtable on February 26, 2021. At both events, EPA staff provided an overview of the TSCA risk management process and the findings in the 2020 Risk Evaluation for NMP (Ref. 28). Attendees of these meetings were given an opportunity to voice their concerns regarding the risk evaluation and risk management.

Furthermore, EPA engaged in discussions with representatives from different industries, non-governmental organizations, technical experts and users of NMP. A list of external meetings held during the development of this proposed rule is in the docket (Ref. 29); meeting materials and summaries are also in the docket. The purpose of these discussions was to create awareness and educate stakeholders and regulated entities on the provisions for risk management required under TSCA section 6(a); explain the risk evaluation findings; obtain input from manufacturers, processors, distributors, users, academics, advisory councils, and members of the public health community about uses of NMP; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to NMP under the conditions of use; understand the importance of NMP in the various uses subject to this proposed rule; compile knowledge about critical uses, substitute chemicals or alternative methods; identify various standards and performance specifications; and generate potential risk reduction strategies. EPA has met with, or otherwise communicated with, a variety of companies, trade associations and non-governmental organizations to discuss the topics outlined in this paragraph; a list of external meetings held during the development of this proposed rule is in the docket (Ref. 29).

The EPA 2021 Policy on Children's Health (Ref. 30) requires EPA to protect children from environmental exposures by consistently and explicitly considering early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health in all human health decisions through identifying and integrating children's health data and information when conducting risk assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk evaluations “to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment . . . including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” Infants, children, and pregnant women are listed as examples of subpopulations that may be considered relevant “potentially exposed or susceptible subpopulations” in the TSCA section 3(12) definition of that term. In addition, TSCA section 6(a) requires EPA to apply one or more risk management requirements under TSCA section 6(a) so that NMP no longer presents an unreasonable risk (including unreasonable risk to PESS). The 2020 Risk Evaluation for NMP evaluated risks of NMP to workers and ONUs, consumers and bystanders, people of reproductive age, pregnant females and the developing embryo/fetus, infants, children and adolescents, people with pre-existing conditions, and people with lower metabolic capacity due to life stage, genetic variation, or impaired liver function as potentially exposed or susceptible subpopulations who may be at greater risk than the general population of adverse developmental health effects from exposure to NMP (Ref. 1). For exposures to infants and males and females of reproductive age, evidence was found of reproductive and developmental toxicity. The reproductive and developmental health effects of concern related to exposures to NMP are reduced male fertility and female fecundity and post-implantation loss (resorptions and fetal mortality). While the literature contains methodological limitations in human studies, animal studies were considered adequate to represent reproductive and development effects in the 2020 Risk Evaluation for NMP.

The 2020 Risk Evaluation for NMP considered impacts on both children and adults from occupational and consumer use from inhalation and dermal exposures, as applicable. For occupational use, the risk evaluation considered males (>16 years of age) and females of reproductive age (>16 years of age to less than 50 years of age) for both dermal and inhalation exposures. For consumer use, EPA evaluated oral exposures based on children's exposure potential via mouthing articles for infants (<1 year), infants (1 to 2 years), and small child (3 to 5 years), and levels were well below the threshold that could result in risk. Additionally for consumer use, the risk evaluation considered dermal and inhalation exposures to females of childbearing age (16 to 49 years) as the most sensitive subpopulation for other individuals, adults, and children. (Ref. 1)

This unit describes the TSCA conditions of use that EPA proposes to regulate, including the conditions of use Start Printed Page 51146 that EPA evaluated and considered in making its unreasonable risk determination for the chemical substance NMP. Condition of use descriptions were obtained from EPA sources such as CDR use codes, the 2020 Risk Evaluation for NMP and related documents, as well as the Organisation for Economic Co-operation and Development harmonized use codes and stakeholder engagements. For clarity and transparency, EPA has narrowly revised the titles for the NMP conditions of use in this proposed rulemaking from the 2020 Risk Evaluation for NMP by removing CDR use code terminology “not described by other codes” and “in other uses” (Refs. 31, 32). For additional description of the conditions of use, including process descriptions and worker activities considered in the risk evaluation, see the Problem Formulation of the 2020 Risk Evaluation for NMP, the 2020 Risk Evaluation for NMP, and supplemental files (Refs. 33, 1, 34). EPA acknowledges that some of the terms in this unit may be defined under other statutes. However, the descriptions here are intended to provide clarity to the regulated entities who will implement the provisions of this rulemaking under TSCA section 6(a).

i. Domestic manufacture. This condition of use refers to the making or producing of a chemical substance within the United States (including manufacturing for export), or the extraction of a component chemical substance from a previously existing chemical substance or a complex combination of substances.

ii. Import. This condition of use refers to the act of causing a chemical substance or mixture to arrive within the customs territory of the United States.

i. Processing as a reactant/intermediate in plastic material and resin manufacturing and other non-incorporative processing. This condition of use refers to when a chemical substance is used in chemical reactions for the manufacturing of another chemical substance or product. Through processing as a reactant or intermediate, NMP serves as a feedstock in the production of another chemical product via a chemical reaction in which NMP is completely consumed. For example, NMP may be used as a polymerization media to manufacture high-temperature polymers or other uses as an intermediate, as a media for synthesis, extractions, and purifications, or as some other type of processing aid.

ii. Processing, incorporation into formulation, mixture or reaction products in multiple industrial sectors. This condition of use refers to the process of mixing or blending several raw materials to obtain a single product or preparation. NMP may be incorporated into various formulations, mixtures, or reaction products including, but not limited to:

• Adhesives and sealant chemicals in adhesive manufacturing;
• Anti-adhesive agents in printing and related support activities;
• Paint additives and coating additives in paint and coating manufacturing and print ink manufacturing;
• Processing aids not otherwise listed in plastic material and resin manufacturing;
• Solvents (for cleaning or degreasing) in non-metallic mineral product manufacturing, machinery manufacturing, plastic material and resin manufacturing, primary metal manufacturing, soap and cleaning compound and toilet preparation manufacturing, transportation equipment manufacturing, all other chemical product and preparation manufacturing, printing and related support activities, services, wholesale and retail trade;
• Surface active agents in soap, cleaning compound and toilet preparation manufacturing;
• Plating agents and surface treating agents in fabricated metal product manufacturing;
• Solvents (which become part of product formulation or mixture) in electrical equipment, appliance and component manufacturing; other manufacturing; paint and coating manufacturing; print ink manufacturing; soap, cleaning compound and toilet preparation manufacturing; transportation equipment manufacturing; all other chemical product and preparation manufacturing; printing and related support activities; wholesale and retail trade; and
• In oil and gas drilling, extraction and support activities; plastic material and resin manufacturing; services.

iii. Processing, incorporation into articles in lubricants and lubricant additives in machinery manufacturing. This condition of use refers to the process or preparation when NMP is incorporated into articles in lubricants and lubricant additives in machinery manufacturing, and metal finishing operations conducted as part of machinery manufacturing. Metal finishing is a broad term used in industry to include a wide variety of processes that alter the surface of metal substrates, such as cleaning, coating, etching, and invasive quality testing.

iv. Processing, incorporation into articles in paint additives and coating additives in transportation equipment manufacturing. This condition of use refers to the process or preparation when NMP is incorporated into articles in paints and coating additives in transportation equipment manufacturing. Transportation equipment manufacturing includes motor vehicle parts motor vehicle body and trailer manufacturing, aerospace product and parts manufacturing, railroad rolling stock manufacturing, and ship and boat building.

v. Processing, incorporation into articles as a solvent (which becomes part of a product formulation or mixture) including in textiles, apparel and leather manufacturing. This condition of use refers to the process or preparation when NMP is incorporated into articles as a solvent in textiles, apparel and leather manufacturing.

vi. Processing, incorporation into articles in other sectors, including in plastic product manufacturing. This condition of use refers to the process or preparation when NMP is incorporated into articles in other sectors, including in plastic product manufacturing. For example, NMP may be used to produce polymeric resins pellets and other shapes that are then converted into final plastic articles.

vii. Processing, repackaging. This condition of use refers to the preparation of a chemical substance or mixture for distribution in commerce in a different form, state, or quantity. This includes, but is not limited to, transferring of NMP from a bulk container into smaller containers.

viii. Processing, recycling. This condition of use refers to processing waste streams of NMP at third-party site for the purpose of recovering materials or otherwise preparing the waste for reuse instead of disposal. Waste solvents can be restored to a condition that permits reuse via solvent reclamation/recycling. The recovery process may involve an initial vapor recovery or mechanical separation step followed by distillation, purification, and final packaging.

i. Industrial and commercial use in paints, coatings, and other adhesive removers. This condition of use refers to the industrial or commercial use of NMP or NMP-containing products to remove paints, coatings, and other adhesive removers from various surfaces indoors or outdoors including, but not Start Printed Page 51147 limited to, graffiti removal from various surfaces.

ii. Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation. This condition of use refers to the industrial or commercial application of NMP-containing products including but not limited to paints and coatings, lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation.

iii. Industrial and commercial use in paint additives in computer and electronic product manufacturing in electronic parts manufacturing. This condition of use refers to the industrial or commercial use of NMP or NMP-containing paint additive and coating additive products in manufacturing and maintaining electrical or electronic parts including but not limited to magnet wire coating, capacitor, resistor, coil, transfer and other inductor manufacturing. This description includes, but is not limited to, use of NMP as an additive in polymeric coatings used to coat magnet wires, often to give them thermal and solvent resistance, and in electrical insulating films.

iv. Industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing for use in semiconductor manufacturing. This condition of use refers to the industrial or commercial use of NMP or NMP-containing paint additive and coating additive products in manufacturing and maintaining semiconductor chip manufacturing. This description includes, but is not limited to, use of NMP as an ingredient for wafer coating and photoresist activities.

v. Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail trade. This condition of use refers to the industrial or commercial application of NMP-containing paint additive and coating additive products including paints, coatings, adhesives and sealants used in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail trade.

vi. Industrial and commercial use as a solvent (for cleaning or degreasing) in electronic equipment, appliance and component manufacturing. This condition of use refers to the industrial or commercial use of NMP or NMP-containing solvent (for cleaning or degreasing) product in manufacturing and maintaining electrical or electronic parts including, but not limited to magnet wire coating, capacitor, resistor, coil, transfer and other inductor manufacturing. This description includes, but is not limited to, use of NMP as a solvent in enamels, thinners, and cleaners to remove coatings and masks and in maintenance and equipment cleaning.

vii. Industrial and commercial use as a solvent (for cleaning or degreasing) in electronic equipment, appliance and component manufacturing for use in semiconductor manufacturing. This condition of use refers to the industrial or commercial use of NMP or NMP-containing containing solvent (for cleaning or degreasing) product in manufacturing and maintaining semiconductor chip manufacturing. This description includes, but is not limited to, the use of NMP for cleaning and stripping wafer surfaces in preparation for other coating formulations and in maintenance and equipment cleaning activities.

viii. Industrial and commercial use in ink, toner and colorant products in printer ink and inks in writing equipment. This condition of use refers to the industrial or commercial use of NMP in printing and writing activities with products containing NMP. This includes printing technologies that use inks containing NMP, such as lithography, flexography, screen, letterpress, and digital technologies, which includes electrophotography and inkjet printing.

ix. Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing, in oil and gas drilling, extraction and support activities, and in functional fluids (closed systems). This condition of use refers to the industrial or commercial use of NMP to improve the processing characteristics or the operation of process equipment or to alter or buffer the pH of the substance or mixture, when added to a process or to a substance or mixture to be processed specific to petroleum production in petrochemical manufacturing. This includes, but is not limited to, use as a processing aid for the extraction, separation, and recovery of aromatic hydrocarbons and other compounds from oils, natural gas, and refinery gases. Processing agents do not become a part of the reaction product and are not intended to affect the function of a substance created.

x. Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives, and two-compound glues and adhesives including some resins. This condition of use refers to the industrial or commercial application of NMP-containing adhesive and sealant products including binding agents, single and two-component glues and adhesives, lubricant additives, and some resins.

xi. Industrial and commercial use in soldering materials. This condition of use refers to the industrial or commercial use of NMP in soldering materials. Soldering is a process in which two or more substrates, or parts (usually metal), are joined together by melting a filler metal material (solder or soldering flux) into the joint and allowing it to cool, thereby joining the independent parts.

xii. Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greases. This condition of use refers to the industrial or commercial use of automotive servicing products containing NMP in servicing and maintenance activities in automotive vehicles. Some products may be applied through aerosol activities, which typically involve the application of a solution from pressurized cans or bottles that use propellant to aerosolize the solution, allowing it to be sprayed onto substrates.

xiii. Industrial and commercial use in metal products not covered elsewhere, and lubricant and lubricant additives including hydrophilic coatings. This condition of use refers to the industrial or commercial use of NMP in products used in metal finishing. Metal finishing is a broad term used in industry to include a wide variety of processes that alter the surface of metal substrates, such as cleaning, coating, etching, and invasive quality testing.

xiv. Industrial and commercial use in laboratory chemicals. This condition of use refers to the industrial or commercial use of NMP in laboratory chemicals. This condition of use refers to the industrial and commercial use of NMP, often in small quantities, in a laboratory process or in specialized laboratory equipment for instrument calibration/maintenance chemical analysis, chemical synthesis, as a carrier chemical, extracting and purifying other chemicals, dissolving other substances, executing research, development, test Start Printed Page 51148 and evaluation methods, and similar activities.

xv. Industrial and commercial use in lithium ion battery manufacturing. This condition of use refers to the industrial or commercial use of NMP or NMP-containing products in manufacturing and maintaining lithium-ion battery cell manufacturing.

xvi. Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removers. This condition of use refers to the industrial or commercial use of NMP in cleaning or degreasing applications, including, but not limited to, use in industrial facilities and commercial shops, as well as products that can be used in multiple applications including, but not limited to, furniture care products, wood cleaners, and gasket removers. EPA identified NMP-containing cleaning products used in applications including, but not limited to, aerosol degreasing, dip/immersion degreasing and cleaning, wipe cleaning, and spray application.

xvii. Industrial and commercial use in fertilizer and other agricultural chemical manufacturing, processing aids and solvents. This condition of use refers to the industrial or commercial use of NMP in the synthesis of and as a co-solvent in the formulation of agricultural chemicals. This description includes the use as an NMP containing fertilizer additive blended into granular or liquid fertilizers.

EPA determined that the condition of use in Unit III.B.1.d.v contributes to the unreasonable risk for NMP. As described in this unit, while EPA determined that seven of the eight consumer uses of NMP do not contribute to the unreasonable risk, the commercial counterparts of these conditions of use do contribute to the unreasonable risk. EPA determined that the seven consumer uses of NMP do not contribute to the unreasonable risk largely due to the generally low concentration of NMP in consumer products and the infrequent use by consumers of those products. (Ref. 1). However, the commercial use of these types of products does contribute to the unreasonable risk because of their generally higher concentrations of NMP or frequency of use in a commercial setting. Therefore, EPA is proposing upstream regulation of these seven consumer uses to address the unreasonable risk from NMP by certain commercial uses so that NMP as a whole chemical no longer presents unreasonable risk, as further discussed in Unit V.A.1.a. The consumer uses that do not contribute to the unreasonable risk for NMP are identified in Unit III.B.1.d.i. through iv. and vi. through viii. Because the potential use of these consumer products by commercial users contributes to their unreasonable risk, EPA is proposing upstream regulation of these consumer conditions of use as described in Unit IV.A.2.

i. Consumer use in paint and coating removers. This condition of use refers to consumer use of NMP-containing products in paint and coating remover products.

ii. Consumer use in adhesive removers. This condition of use refers to consumer use of NMP-containing products in adhesive remover products.

iii. Consumer use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes. This condition of use refers to consumer use of NMP-containing products in paints and coatings products including lacquers, stains, varnishes, primers and floor finishes.

iv. Consumer use in paint additives and coating additives in paints and arts and crafts paints. This condition of use refers to consumer use of NMP-containing products in paint additive and coating additive products including paints and arts and crafts paints.

v. Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives. This condition of use refers to consumer use of NMP-containing products in adhesive and sealant products.

vi. Consumer use in automotive care products. This condition of use refers to consumer use of NMP-containing products in automotive care products. This description includes automotive interior cleaning products.

vii. Consumer use in cleaning and furniture care products, including wood cleaners and gasket removers. This condition of use refers to consumer use of NMP-containing products in cleaning and furniture care products, including wood cleaners and gasket removers. This description includes cleaners and degreasers and engine cleaners and degreasers.

viii. Consumer use in lubricant and lubricant additives, including hydrophilic coatings. This condition of use refers to consumer use of NMP-containing products in lubricant and lubricant additive products.

This condition of use refers to the process of disposing generated waste streams of NMP that are collected either on-site or collected and transported to a third-party site, such as waste incineration sites, for disposal.

For purposes of this proposed rulemaking “occupational conditions of use” refers to the TSCA conditions of use described in Units III.B.1.a., b., c., and e. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for NMP for purposes of distinguishing scenarios, the Agency clarified then and clarifies now that EPA interprets the authority over “any manner or method of commercial use” under TSCA section 6(a)(5) to reach both.

Additionally, in the 2020 Risk Evaluation for the chemical substance NMP, EPA identified and assessed all known, intended, and reasonably foreseen processing, industrial, commercial, and consumer uses of NMP in order to determine whether NMP as a whole chemical substance presents unreasonable risks to health and the environment. EPA determined that all processing, industrial, and commercial uses of NMP evaluated in the 2020 Risk Evaluation for NMP contribute to the EPA determination that NMP presents unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, “processing” refers to all processing, including known, intended, and reasonably foreseen processing of NMP. Likewise, for the purpose of this risk management rulemaking, “industrial and commercial use” refers to all industrial and commercial uses, including known, intended, or reasonably foreseen NMP industrial and commercial use.

EPA is not proposing to incorporate the descriptions in Unit III.B.1.a. through e. into the regulatory text as definitions. EPA requests comment on whether EPA should promulgate definitions for those conditions of use evaluated in the 2020 Risk Evaluation for NMP that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for NMP and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation. EPA further notes that this proposed rule does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). Those exclusions include, but are not limited to, any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; and any food, food additive, drug, cosmetic, or device, Start Printed Page 51149 as defined in the Federal Food, Drug, and Cosmetic Act (FFDCA) section 201, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device. For example, the proposed rule does not apply to NMP used as a nail polish remover, provided it is manufactured, processed, or distributed in commerce for such use, because nail polish remover is a cosmetic as defined in FFDCA section 201(i).

EPA has determined that NMP presents an unreasonable risk of injury to human health under the conditions of use based on acute and chronic non-cancer risks. As described in the TSCA section 6(b) 2020 Risk Evaluation for NMP, EPA identified non-cancer adverse effects from acute and chronic inhalation and dermal exposures to NMP. EPA identified that the best representative endpoints for non-cancer effects were from acute (developmental toxicity) and chronic (reproductive toxicity) inhalation and dermal exposures for all conditions of use. Additional risks associated with other adverse effects ( e.g., liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation and sensitization) were identified for acute and chronic inhalation and dermal exposures. EPA did not evaluate cancer risk from exposure to NMP because NMP is not mutagenic and is not considered carcinogenic. Unit VI.A. summarizes the health effects and the magnitude of exposures (Ref. 1).

The 2020 Risk Evaluation for NMP assessed exposure from inhalation, dermal, and vapor through skin exposure, and identified that the unreasonable risk of injury to human health is mainly driven by direct dermal contact with NMP. Therefore, EPA is proposing dermal exposure controls (or, as needed, prohibitions) to prevent direct dermal contact with NMP. While inhalation risks contribute to the unreasonable risk from NMP, addressing inhalation risks alone would not mitigate the unreasonable risk from NMP. For a small number of conditions of use where inhalation and dermal exposures both significantly contribute to the unreasonable risk, EPA is proposing inhalation and dermal exposure controls. The measures to address the unreasonable risk are discussed further in Unit IV., and the rationale for these measures are discussed further in Unit V.

To make the unreasonable risk determination for NMP, EPA evaluated exposures to workers, ONUs, consumer users, and bystanders to consumer use using reasonably available monitoring and modeling data for inhalation and dermal exposures. EPA conducted a screening-level analysis to assess potential risks from the air and water pathways to fenceline communities. A discussion of EPA's analysis and the expected effects of this rulemaking on fenceline communities is in Unit VI.A.

For the 2020 Risk Evaluation for NMP, EPA considered PESS. EPA identified the following groups as PESS: workers, ONUs, consumers, bystanders, males and females of reproductive age, pregnant women and the developing embryo/fetus, infants, children, and adolescents, people with pre-existing conditions and people with lower metabolic capacity due to life stage, genetic variation, or impaired liver function (Ref. 1). All PESS are included in the quantitative and qualitative analyses described in the risk evaluation, and were considered in the determination of unreasonable risk for NMP. As discussed in Unit II.D. and Unit VI.A., the 2020 Risk Evaluation for NMP did not fully assess some exposure pathways, including the air and surface water exposure pathways to the general population from the published risk evaluations and may have caused some risks to be unaccounted for in the risk evaluation. EPA considers these communities a subset of the general population and categorizes them as fenceline communities; they may also be considered PESS. See Unit VI.A. for further discussion on assessing and protecting against risk to fenceline communities.

EPA examined the TSCA section 6(a) requirements (listed in Unit III.A.) to identify which ones have the potential to address the unreasonable risk for NMP.

As required, EPA developed a proposed regulatory action and an alternative regulatory action, which are described in Units IV.A. and IV.B., respectively. To identify and select a regulatory action, EPA considered the two routes of exposure driving the unreasonable risk, inhalation and dermal, and the exposed populations. For occupational conditions of use (see Unit III.B.1.f.), EPA considered how it could directly regulate manufacturing (including import), processing, distribution in commerce, industrial and commercial use, or disposal to address the unreasonable risk. EPA does not have direct authority to regulate consumer use. Therefore, EPA considered how it could exercise its authority under TSCA to regulate the manufacturing (including import), processing, and/or distribution in commerce of NMP at different points in the supply chain to eliminate exposures or restrict the availability of NMP and NMP-containing products for consumer use to address the unreasonable risk.

As required by TSCA Section 6(c)(2), EPA considered several factors, in addition to identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: (i) The effects of NMP on health and the environment, (ii) The magnitude of exposure to NMP of human beings and the environment, (iii) The benefits of NMP for various uses, and (iv) The reasonably ascertainable economic consequences of the rule. In evaluating the reasonably ascertainable economic consequences of the rule, EPA considered: (i) The likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (ii) The costs and benefits of the proposed regulatory action and alternative regulatory action considered; and (iii) The cost effectiveness of the proposed regulatory action and of the alternative regulatory action considered. See Unit VI. for further discussion related to TSCA section 6(c)(2)(A) considerations, including the statement of effects of the proposed rule with respect to these considerations.

EPA also considered the regulatory authority under TSCA and other statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and other EPA-administered statutes to examine: (1) Whether there are opportunities for all or part of risk management action on NMP to be addressed under other statutes, such that a referral may be warranted under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a) regulation could include alignment of requirements and definitions in and under existing statutes to minimize confusion to the regulated entities and the general public.

In addition, EPA followed other TSCA requirements such as considering the availability of alternatives when contemplating prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as outlined in Unit IV.B.), and setting proposed compliance dates in accordance with the requirements in TSCA section 6(d)(1) (described in the proposed and alternative regulatory actions in Unit IV.).

To the extent information was reasonably available, when selecting regulatory actions, EPA considered pollution prevention and the hierarchy Start Printed Page 51150 of controls adopted by OSHA and NIOSH, with the goal of identifying risk management control methods that are permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated entities where appropriate. EPA considered the information presented in the 2020 Risk Evaluation for NMP, as well as additional input from stakeholders (as described in Unit III.A.), and anticipated compliance strategies from regulated entities.

Taken together, these considerations led EPA to the proposed regulatory action and alternative regulatory action described in Unit IV. Additional details related to how the requirements in this unit were incorporated into development of those actions are in Unit V.

This unit describes the proposed regulatory action by EPA so that NMP will no longer present an unreasonable risk of injury to health. In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider the costs and benefits and the cost-effectiveness of the proposed regulatory action and alternative regulatory action. In the case of NMP, the proposed regulatory action is described in Unit IV.A. and the alternative regulatory action considered is described in Unit IV.B. An overview of the proposed regulatory action and alternative regulatory action for each condition of use is in Unit IV.C. The rationale for the proposed and alternative regulatory action and associated compliance timeframes are discussed in this unit and in more detail in Unit V.A. Discussion of the consideration of TSCA section 6(c)(2)(A) is further described in Unit VI.

EPA is proposing, under TSCA section 6(a) to: Prohibit the manufacture (including import), processing, distribution in commerce, and industrial and commercial use of NMP for five occupational uses; Require container size limits and labeling requirements for the manufacture (including import), processing, and distribution in commerce of NMP products for seven consumer uses; Require prescriptive controls, including concentration limits and PPE, for seven occupational conditions of use; Require strict workplace controls, including an NMP WCPP, which would include requirements to prevent direct dermal contact with NMP, for all other occupational conditions of use; Require a concentration limit on NMP for the import, processing, and distribution in commerce for one consumer use; and Establish recordkeeping and downstream notification requirements. Pursuant to TSCA section 12(a)(2), this proposed rule would apply to NMP even if being manufactured, processed, or distributed in commerce solely for export from the United States because EPA has determined that NMP presents an unreasonable risk to health or the environment within the United States.

To aid the regulated community with implementing the prohibitions and restrictions, and to account for de minimis levels of NMP as an impurity in products, EPA is proposing that products containing NMP at concentrations less than 0.1% by weight would not be subject to the prohibitions and restrictions described in this unit. EPA has determined that the prohibitions and restrictions would only be necessary for products containing NMP at levels equal to or greater than 0.1% by weight to eliminate the unreasonable risk of injury resulting from inhalation and dermal exposures from NMP-containing products during occupational and consumer conditions of use. EPA's description for how allowing for a concentration of NMP up to 0.1% would not hinder the ability of this rulemaking to address the unreasonable risk associated with NMP-containing products and rationale for this regulatory approach are in Unit V.A. EPA requests comment on allowing this de minimis level of NMP in products to account for impurities.

EPA is proposing to prohibit the manufacturing (including import), processing, distribution in commerce, and use of NMP for the following conditions of use:

• Processing incorporation into articles in lubricants and lubricant additives in machinery manufacturing;
• Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greases;
• Industrial and commercial use in metal products not covered elsewhere and lubricant and lubricant additives including hydrophilic coatings;
• Industrial and commercial use in cleaning and degreasing and cleaning and furniture care products, including wood cleaners and gasket removers; and
• Industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents.

The industrial and commercial uses of NMP in specialized electronics, such as lithium ion battery manufacturing for use in electronic vehicles or semiconductor manufacturing, and the associated upstream manufacturing (including import) and processing uses are not prohibited. EPA supports the continuation of these specialized electronic uses while addressing the unreasonable risk through appropriate exposure controls, detailed in Unit IV.A.3.

As discussed in Units III.B.3. and V.A., based on the Agency's consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad range of work environments and activities, and the irreversible health effects associated with NMP exposures, EPA has determined that prohibition of the conditions of use identified in this unit is the best way to address the unreasonable risk from NMP. EPA believes there are a sufficient number of alternatives for these uses, described further in Unit V.B. and the Alternatives Assessment (Ref. 4).

EPA is proposing that the prohibitions on manufacturing (including import), processing, distribution in commerce, and industrial and commercial use of NMP for these conditions of use would follow a staggered schedule, due to supply chain considerations. EPA proposes that the compliance dates for the proposed prohibitions described in this unit would come into effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users after the publication date of the final rule. When proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with NMP exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time is needed for products to clear the channels of trade. For NMP, for the conditions of use EPA is proposing to prohibit, the Agency believes either NMP may no longer be used or regulated entities would be able to meet the proposed or alternative compliance timeframes due to availability of alternatives. EPA recognizes that for other proposed regulations under TSCA Start Printed Page 51151 section 6, including methylene chloride ( 88 FR 28284 , May 3, 20230 (FRL-8155-02-OCSPP), perchloroethylene ( 88 FR 39652 , June 16, 2023) (FRL-8329-02-OCSPP), and carbon tetrachloride ( 88 FR 49180 , July 28, 2023) (RL-8206-01-OCSPP), public comments have provided information in support of longer compliance timeframes. Similarly, for NMP, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes. Comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation. EPA also requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. EPA is also requesting comment on: (1) whether respiratory protection and dermal PPE should be required before the effective date of the prohibition; (2) to what extent inhalation and dermal PPE may already be implemented in most uses being prohibited; and (3) whether requirements that inhalation and dermal PPE be used before the effective dates of prohibitions would be overly burdensome to entities indicated in this unit that would be working to comply with the prohibition. EPA is requesting comments from the public for more information about the uses EPA is proposing to prohibit, particularly the industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents, and the ability for workplaces in these conditions of use to comply with strict workplace controls like those required under the WCPP, or the ability to comply with a prohibition and reformulate to an alternative chemical or process.

Additionally, EPA recognizes that there may be instances where an ongoing use of NMP that has implications for national security or critical infrastructure as it relates to other Federal agencies ( e.g., DOD, DOE, NASA) is identified after the NMP rule is finalized, but the final rule prohibits that use. For instances like that, EPA requests comments on an appropriate, predictable process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued using the tools available under TSCA, aligning with the requirements of TSCA section 6(g). One example of an approach could be the establishment by rulemaking of a Federal agency category of use that would require implementation of the WCPP and periodic reporting to EPA on details of the use as well as progress in discontinuing the use or finding a suitable alternative. To utilize the category of use a Federal agency would petition EPA, supported by documentation describing the specific use (including documentation of the specific need, service life of any relevant equipment, and specific identification of any applicable regulatory requirements or certifications, as well as the location and quantity of the chemical being used); the implications of cessation of this use for national security or critical infrastructure (including how the specific use would prevent injuries/fatalities or otherwise provide life-supporting functions); exposure control plan; and, for Federal agency uses where similar adoption by the commercial sector may be likely, concrete steps taken to identify, test, and qualify substitutes for the uses (including details on the substitutes tested and the specific certifications that would require updating; and estimates of the time required to identify, test, and qualify substitutes with supporting documentation). In the event that sensitive information relating to national security or critical infrastructure would be submitted to EPA, EPA would protect the submitted information in accordance with applicable authorities. EPA requests comment on whether these are the appropriate types of information for use in evaluating this type of category of use, and whether there are other considerations that should apply. EPA would make a decision on the petition within 30 days and publish the decision in the Federal Register shortly after. Additionally, during the year following the petition, EPA would take public comment on the approved petition and no later than 180 days after submitting the petition to EPA, the requesting agency would submit monitoring data indicating compliance with the WCPP at each relevant location as well as documentation of efforts to identify or qualify substitutes. In the absence of that confirmatory data, the utilization of the generic Federal agency category of use would expire within one year of the date of receipt by EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking for those instances where the Federal agency could not demonstrate compliance with the WCPP. This is just one example of a potential process. EPA requests comments on a process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued.

EPA continues to work with Federal agency partners to develop a regulatory approach to accommodate uses needed for national security or critical infrastructure purposes in a manner that complies with EPA requirements for implementation of a workplace chemical protection plan (WCPP) and any other EPA identified protective measures intended to mitigate an unreasonable risk of injury to health or the environment. EPA solicits comment on all aspects of its steps to accommodate these uses in this proposed rule and whether any additional measures are needed.

EPA has identified consumer products similar to the commercial products proposed to be prohibited. While EPA determined that the consumer uses of NMP listed in this unit do not contribute to the unreasonable risk, EPA found that the commercial counterparts of these conditions of use do contribute to the unreasonable risk due to the increased exposure from more frequent use. As described in Unit III.B.3., under TSCA section 6(a), EPA is required to issue a regulation applying one or more of the TSCA section 6(a) requirements to the extent necessary so that the unreasonable risk of injury to health or the environment from a chemical substance is no longer presented. As such, EPA is proposing tailored upstream regulations for these consumer conditions of use to manage the exposures to similar commercial conditions of use. In this way, NMP would not present unreasonable risk to workers. These restrictions are intended to prevent the consumer products intended for consumer use from being unlawfully used in commercial activities. EPA is proposing to prohibit the import, processing, and distribution in commerce of NMP or NMP-containing products for these consumer uses of NMP if the containers exceed a Start Printed Page 51152 volume more than 16 ounces. The rationale for this container size volume is described in Unit V.A.1.b.

EPA is proposing to restrict the container size and require labels for NMP-containing products for the following consumer uses:

• In paint and coating removers;
• In adhesive removers;
• In paints and coatings in lacquer, stains, varnishes, primers and floor finishes;
• In paint additives and coating additives in paints and arts and crafts paints;
• In automotive care products;
• In cleaning and furniture care products, including wood cleaners, gasket removers; and
• In lubricant and lubricant additives, including hydrophilic coatings.

EPA is requesting public comment on whether meeting this container size restriction to prevent commercial use would also have the same, though unintended, effect of reducing the consumer use.

Additionally, to prevent commercial use of these consumer products, EPA is proposing to require all importers, processors, and distributors in commerce of the NMP-containing products for the conditions of use listed in this unit to provide a label securely attached to each product. Label information would be required to be prominently displayed in an easily readable font size, and contain the following text including the sentence “This product is only for sale in containers of 16 ounces or less and is for consumer use only” in italic print or a larger font for emphasis:

This product contains n-methylpyrrolidone (NMP) (CASRN 872-50-4), also called n-methyl-2-pyrrolidone or 1-methyl-2-pyrrolidone, a chemical determined by the Environmental Protection Agency to present unreasonable risk of injury to health under the Toxic Substances Control Act (TSCA), based on developmental and reproductive effects. The use of NMP is restricted under 40 CFR part 751, subpart C . This product is only for sale in containers of 16 ounces or less and is for consumer use only. This product shall not be used for commercial purposes.

EPA is proposing that the container size limit and labeling requirements described in this unit take effect 12 months after the publication date of the final rule in the Federal Register for import, processing, and distribution in commerce. EPA has no reasonably available information indicating these proposed compliance dates are not practicable for the activities that would require repackaging and labeling or that additional time is needed for products to clear the channels of trade. However, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the container size restriction, and on what an appropriate container size restriction should be if not 16 ounces, and why. EPA is also seeking public comment on any alternative options to prevent diversion of consumer products to commercial uses. Comments should include documentation such as the specific container sizes of the NMP-containing products and estimates of the time and expenses required to implement the labeling requirement. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

EPA is proposing Direct Dermal Contact Control (DDCC) requirements as part of the WCPP for the manufacturing, processing, and use of NMP for all industrial and commercial uses, except for those conditions of use which would be prohibited (as described in Unit IV.A.1) or subject to prescriptive controls (as described in Unit IV A.4). This would include requirements to comply with the WCPP for the following conditions of use:

• Manufacturing (domestic manufacturing);
• Manufacturing (import);
• All processing, excluding conditions of use for which prohibition or prescriptive controls are proposed (which are listed in Unit IV.A.1 and IV.A.4, respectively). All processing includes, but is not limited to: processing as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative processing; processing incorporation into a formulation, mixture or reaction product in multiple industrial sectors; processing incorporation into articles as a solvent (which becomes part of a product formulation or mixture) including in textiles, apparel and leather manufacturing; processing incorporation into articles in other sectors, including in plastic product manufacturing; processing by repackaging in wholesale and retail trade; processing by recycling;
• All industrial and commercial uses, excluding conditions of use for which prohibition or prescriptive controls are proposed (which are listed in Units IV.A.1 and IV.A.4, respectively). All industrial and commercial uses includes, but is not limited to: industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in electronic parts manufacturing; industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in semiconductor manufacturing; industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing; industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing for use in semiconductor manufacturing; industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing in oil and gas drilling, extraction and support activities, and in functional fluids (close systems); industrial and commercial use in laboratory chemicals; industrial and commercial uses in lithium ion battery manufacturing; industrial and commercial use in paints and coatings and paint, coating, and adhesive removers by DOD, NASA, and their contractor for mission-critical components on government-operated aerospace vehicles, vessels, and military weapons systems, including mission- or safety-critical components; and

As described in Unit III.B.3., EPA is required to issue a regulation applying one or more of the TSCA section 6(a) requirements to the extent necessary so that the unreasonable risk of injury to health or the environment from a chemical substance is no longer presented. The TSCA section 6(a) requirements provide EPA the authority to limit or restrict a number of activities, alone or in combination, including the manufacture, processing, distribution in commerce, commercial use, and disposal of the chemical substance. Given this authority, EPA may find it appropriate in certain circumstances to propose requirements under a WCPP for certain occupational ( e.g., manufacturing, processing, industrial and commercial use, and disposal) conditions of use. The WCPP for NMP would encompass DDCC requirements, and the associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk.

Under a WCPP, owners or operators would have some flexibility, within the parameters outlined in this unit, regarding how they prevent direct dermal contact. In the case of NMP, Start Printed Page 51153 implementing the DDCC requirements for certain occupational conditions of use would address unreasonable risk to potentially exposed persons from dermal exposure.

EPA uses the term “potentially exposed person” in this unit and in the regulatory text to include workers, occupational non-users, employees, independent contractors, employers, and all other persons in the work area where NMP is present and who may be exposed to NMP under the conditions of use for which a WCPP would apply. One important reason to define a potentially exposed person for the purposes of a WCPP as any person who may be exposed in the workplace is to emphasize the broad scope of exposures which must be categorized when implementing a WCPP. EPA notes that this definition is intended to apply only in the context of risk management, and specifically in the context of a WCPP ( e.g., workers directly using the chemical, workers in the vicinity of the use, students in a laboratory setting). The term is not intended as a replacement for the term Potentially Exposed or Susceptible Subpopulation as defined by TSCA section 3(12). EPA additionally recognizes that other individuals or communities may be exposed to NMP as consumers, members of fenceline communities, or members of the general population, which is separate and apart from those potentially exposed for the purposes of the regulatory requirements of the WCPP. In those instances, where regulatory requirements address exposures unrelated to a WCPP EPA would use distinct terminology to refer to those other populations. EPA's intention is to require a comprehensive WCPP that would address the unreasonable risks from NMP to potentially exposed persons directly handling the chemical or in the area where the chemical is being used.

Similarly, the 2020 risk evaluation for NMP did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of NMP.

EPA uses the term “owner or operator” to describe the entity responsible for implementing the WCPP for workplaces where an applicable condition of use is occurring and NMP is present. The term includes any person who owns, leases, operates, controls, or supervises such a workplace.

DDCC requirements are process-based approaches to prevent direct dermal contact with NMP and associated implementation requirements described in this unit to ensure that the chemical substance no longer presents unreasonable risk from dermal exposure. DDCC requirements allow regulated entities some flexibility within certain parameters outlined in this unit for preventing direct dermal contact with NMP. In the case of NMP, EPA has preliminarily determined that preventing direct dermal contact through DDCC requirements for certain conditions of use would address their contribution to the unreasonable risk from NMP. NMP is slightly volatile, and preventing direct dermal contact with NMP would also inherently reduce inhalation exposure by reducing concentration of NMP in air from volatilization, further preventing unreasonable risk to workers.

This unit includes a summary of the proposed NMP WCPP, including a description of the proposed DDCC requirements and associated implementation requirements; consideration of the NIOSH hierarchy of controls (hereafter referred to as “hierarchy of controls”); and additional requirements proposed for recordkeeping, workplace training, workplace participation, and notification. This unit also describes compliance timeframes for these proposed requirements.

i. Direct dermal contact. DDCC requirements are a process-based set of provisions to address unreasonable risk driven by dermal exposure by preventing direct dermal contact in the workplace. To address the unreasonable risk driven by dermal exposure to NMP, DDCC requirements would include controls to separate, distance, physically remove, or isolate all person(s) from direct handling of NMP or from skin contact with surfaces that may be contaminated with NMP ( i.e., equipment or materials on which NMP may be present) under routine conditions in the workplace (hereafter referred to as direct dermal contact). The 2020 Risk Evaluation for NMP assessed risks to workers from inhalation and dermal exposure, and concluded the risk was driven by the dermal exposure, mainly direct skin contact with NMP. Risk exceeding the benchmark was identified even when considering use of chemically resistant gloves in most commercial and industrial conditions of use. The 2020 Risk Evaluation deduced that direct dermal contact drives the unreasonable risk by comparing the internal exposure to workers with inhalation, vapor through skin and dermal liquid contact with internal exposure to ONUs due to inhalation and vapor through skin exposure (a subtraction technique). The percent exposure to NMP due to dermal contact with liquid is provided in table 4-54 in section 4.3.7 of the 2020 Risk Evaluation (Ref. 1). EPA's description for how the requirements related to DDCC would address the unreasonable risk resulting from dermal exposures and the rationale for this regulatory approach is outlined in Units III.B.3. and V.A.

As part of DDCC requirements, EPA is proposing to require owners and operators to implement dermal exposure controls in accordance with the hierarchy of controls. EPA also recommends and encourages the use of pollution prevention as a means of controlling exposures whenever practicable. EPA is also proposing to align DDCC requirements with the implementation of several OSHA standards, including the hazard communication ( 29 CFR 1910.1200 ) and general PPE requirements standards ( 29 CFR 1910.132 ), recognizing that OSHA has not set an exposure limit for inhalation or direct dermal exposure for NMP.

Within certain parameters outlined in this unit, DDCC requirements are non-prescriptive, in the sense that it does not require a specific control to prevent direct dermal contact. Rather, it would enable regulated entities to determine how to most effectively prevent direct dermal contact based on what works best for their workplace, in accordance with the hierarchy of controls. Each owner or operator of a workplace engaging in a condition of use for which DDCC requirements are proposed would be responsible for compliance with the DDCC requirements and recordkeeping.

As discussed briefly in Unit IV.A.1. and further in Unit V.A.1., EPA expects that many workplaces already have stringent controls in place that reduce dermal exposures to NMP; for some workplaces, EPA understands that these existing controls may already prevent or reduce direct dermal contact with NMP to the extent necessary to address the unreasonable risk.

ii. Incorporation of the hierarchy of controls. EPA is proposing to require owners or operators to implement DDCC requirements in accordance with the hierarchy of controls and encourages the use of pollution prevention to control exposures whenever practicable. EPA recognizes that some owners or operators may have industrial hygiene practices already preventing direct dermal contact with NMP in the workplace. For example, the semiconductor sector has provided EPA Start Printed Page 51154 with information about the exposure reduction measures in their facilities, which are aligned with industrial hygiene best practices to prevent direct dermal contact with NMP, similar to that EPA is proposing. For workplaces that cannot feasibly eliminate the source of NMP dermal exposure or replace NMP with a substitute, workplaces would have to use engineering and/or administrative controls to implement process changes to prevent direct dermal contact with NMP to the extent feasible. If an owner or operator chooses to replace NMP with a substitute, EPA recommends that they carefully review the available hazard and exposure information on the potential substitutes to avoid a regrettable substitution, including alternatives identified in the Alternatives Analysis, which is further described in Unit V.B. If an effort to identify and implement feasible exposure controls such as elimination, substitution, engineering controls and administrative controls is not sufficient to prevent direct dermal contact with NMP for potentially exposed persons in the workplace, EPA proposes to require each owner and operator to reduce to the extent practicable the potential for direct dermal contact with NMP in the workplace by these controls and to supplement these controls using PPE. Examples of engineering controls that may prevent or reduce the potential for direct dermal contact include automation, physical barriers between contaminated and clean work areas, enclosed transfer liquid lines (with purging mechanisms in place ( e.g., nitrogen, aqueous) for operations such as product changes or cleaning), and design of tools ( e.g., a closed-loop container system providing contact-free connection for unloading fresh and collecting spent solvents, pneumatic tools, tongs, funnels, glove bags, etc.). Examples of administrative controls that may prevent or reduce the potential for direct dermal contact include adjusting work practices ( i.e., implementing policies and procedures) such as providing safe working distances from areas where direct handling of NMP may occur.

EPA requests comment on available approaches, specifically monitoring methods ( e.g., charcoal patch testing) and frequency of sampling, to determine the effectiveness of engineering and administrative controls in preventing or reducing potential direct dermal contact to NMP. EPA also requests comment on whether requiring reporting on such monitoring could support enforcement and compliance assurance with this rulemaking.

EPA proposes to require that owners and operators document their implementation efforts and compliance with DDCC requirements in an exposure control plan or through any existing documentation of the facility's “Safety and Health Program” that may already be developed as part of meeting OSHA requirements or other safety and health standards (Ref. 35), as described in Unit IV.A.3.d.

iii. Restricted area. EPA is proposing to require that each owner or operator subject to a WCPP designate any area where direct dermal contact with NMP may occur (after considering elimination, substitution, engineering controls, and administrative controls) as a “restricted area.” This restricted area would be demarcated using administrative controls such as highly visible signifiers, in multiple languages as appropriate ( e.g., based on languages spoken by potentially exposed persons who work in the restricted area), placed in conspicuous areas and documented through training and recordkeeping. EPA proposes to require that each owner or operator prevent access to the “restricted area” for any potentially exposed person that lacks proper training; is not wearing required PPE; or is otherwise unauthorized to enter. EPA requests comment on whether there should be general housekeeping or cleaning requirements in areas where the NMP is handled or where surfaces may be contaminated with NMP. EPA is also soliciting comment on requiring warning signs to demarcate restricted areas, similar to the requirements found in OSHA's General Industry Standard for Beryllium ( 29 CFR 1910.1024(m)(2) ).

Where elimination, substitution, engineering controls, and administrative controls are not feasible or sufficient to fully prevent direct dermal contact with NMP, EPA is proposing to require implementation of a PPE program in alignment with OSHA's General Requirements for Personal Protective Equipment at 29 CFR 1910.132 . In choosing appropriate PPE, owners and operators would be required to select gloves (which may require glove testing), clothing, and protective gear (which covers any exposed dermal area of arms, legs, torso, and face) based on specifications from the manufacturer or supplier that demonstrate an impervious barrier to NMP during expected durations of use and normal conditions of exposure within the workplace, accounting for potential chemical permeation or breakthrough times. Where respirators are prescribed, as described in Unit IV.A.4., EPA is proposing to require each owner or operator select respiratory protection in accordance with the guidelines described in this unit and 29 CFR 1910.134(a) through (l) , except (d)(1)(iii) and (d)(3)(i)(B), for proper respirator use, maintenance, fit-testing, medical evaluation, and training.

Owners and operators would be required to select dermal PPE in accordance with provisions of 29 CFR 1910.132 and in alignment with the OSHA Hand Protection PPE Standard ( 29 CFR 1910.138 ); owners and operators would also be required to select dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use. Further information related to choosing appropriate PPE, including specific examples of PPE types, can be found in appendix F of the Risk Evaluation (Ref. 1).

For example, owners and operators could select gloves that have been tested in accordance with the American Society for Testing Material (ASTM) F739 “Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact.” EPA is proposing that PPE be provided for use for a time period only to the extent and no longer than the time period for which testing has demonstrated that the PPE will be impermeable during expected durations of use and conditions of exposure. EPA is proposing to require that owners and operators also consider other factors when selecting appropriate PPE, including effectiveness of glove type when preventing exposures from NMP alone and in likely combination with other chemical substances used in the work area or when used with glove liners, permeation, degree of dexterity required to perform tasks, and temperature, as identified in the Hand Protection section of OSHA's Personal Protective Equipment Guidance and in alignment with the OSHA Hand Protection PPE Standard ( 29 CFR 1910.138 ), owners and operators would be required to select dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use (Ref. 36).

EPA is proposing that owners and operators would be required to establish, either through manufacturer or supplier-provided documentation or individually prepared third-party testing, that the selected PPE would be Start Printed Page 51155 impervious for the expected duration and conditions of exposure by reporting cumulative permeation rate as a function of time ( e.g., by using the suggested format presented in ASTM F1194, “Standard Guide for Documenting the Results of Chemical Permeation Testing of Materials Used in Protective Clothing,” or equivalent manufacturer- or supplier-provided testing). Owners and operators would also be required to consider likely combinations of chemical substances to which the clothing may be exposed in the work area when selecting the appropriate PPE such that the PPE will prevent direct dermal contact to NMP. EPA is proposing that PPE must be immediately provided and replaced if any person is dermally exposed to NMP longer than the breakthrough time period for which testing has demonstrated that the PPE will be impermeable or if there is a chemical permeation or breakage of the PPE.

Also consistent with 29 CFR 1910.132 , owners and operators would be required to provide any person in the workplace with PPE and provide training on proper use ( e.g., when and where PPE is necessary, proper application, wear, and removal of PPE, and maintenance, useful life and disposal of PPE) where the potential for direct dermal contact with NMP may exist. Owners and operators would also have to re-train any affected persons potentially exposed to direct dermal contact with NMP whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE or when changes in the workplace, or in the PPE to be used, render the previous training obsolete.

Additionally, EPA is proposing to require that owners and operators subject to this rulemaking comply with provisions of 29 CFR 1910.133(b) for requirements on selection and use of eye and face protection. Similarly, EPA is proposing to require that owners and operators subject to this rulemaking who would be required to administer a respiratory protection program do so with worksite-specific procedures and elements for required respirator use in accordance with 29 CFR 1910.134(a) through (l) , except 29 CFR 1910.134(d)(1)(iii) and (d)(3)(i)(B) , for proper respirator use, maintenance, fit-testing, medical evaluation, and training. While EPA does not propose that the WCPP for NMP proposed for the conditions of use listed earlier in this unit include respiratory protection requirements, EPA notes that the proposed prescriptive controls for conditions of use listed in Unit IV.A.4. would include respiratory protection. For respiratory PPE, EPA is proposing that the owner or operator must ensure that all cartridges and canisters used in the workplace are labeled and color coded with the NIOSH approval label and that the label is not removed and remains legible. 29 CFR 1910.134(d)(3)(iii) , which EPA is proposing to cross-reference, requires either the use of respirators with an end-of-life service indicator certified by NIOSH for the contaminant, in this case NMP, or implementation of a change schedule for canisters and cartridges that ensures that they are changed before the end of their service life. EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA's General Industry Standard for 1,3-Butadiene ( 29 CFR 1910.1051(h) ), or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA's General Industry Standard for Benzene ( 29 CFR 1910.1028(g)(3)(D) ). Further information related to choosing appropriate respirators, including specific examples of respirator types, can be found in appendix F of the 2020 Risk Evaluation for NMP (Ref. 1).

EPA proposes to require that owners and operators document in the exposure control plan, or other documentation of the facility's safety and health program, information relevant to respiratory program, including records on the name, workplace address, work shift, job classification, work area, and type of respirator worn (if any) by each potentially exposed person, maintenance, and fit-testing, as described in 29 CFR 1910.134(f) , and training in accordance with 29 CFR 1910.132(f) and 29 CFR 1910.134(k) .

EPA is soliciting comments on the non-prescriptive proposed DDCC requirements for appropriate PPE selection, the effectiveness of PPE in preventing direct dermal contact with NMP in the workplace. EPA requests information on other potential dermal performance standards, and on general absorption and permeation effects to PPE as a result of direct contact.

In addition, EPA understands that some workplaces rinse and reuse PPE after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing certain types of PPE, either gloves or protective clothing and gear. EPA also requests comment on the degree to which additional guidance related to use of PPE might be appropriate, including specifying PPE type or additional standard testing specifications.

EPA is also proposing that owners and operators retain records of the PPE that is used and program implementation. EPA proposes to require that owners and operators document in the exposure control plan, or other documentation of the facility's safety and health program, information relevant to any PPE program, as applicable, including: (A) the name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle NMP or handle equipment or materials on which NMP may present and the type of PPE selected to be worn by each of these persons; (B) the basis for specific PPE selection ( e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area); (C) appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE; (D) occurrence and duration of any direct dermal contact with NMP that occurs during any activity or malfunction at the workplace that causes direct dermal exposures to occur and/or glove breakthrough, and corrective actions to be taken during and immediately following that activity or malfunction to prevent direct dermal contact to NMP; and (E) training in accordance with 29 CFR 1910.132(f) , including any re-training. EPA may require more, less, or different documentation in the final rule based on consideration of public comments.

i. Exposure control plan. EPA proposes to require that owners and operators document their exposure control strategy and implementation in an exposure control plan or through adding EPA-required information to any existing documentation of the facility's safety and health program developed as part of meeting OSHA requirements or other safety and health standards. EPA proposes to require that each owner or operator document in the exposure control plan the following:

(A) Identification and rationale of exposure controls used or not used in the following sequence: elimination of NMP, substitution of NMP, engineering controls, and administrative controls to prevent or reduce direct dermal contact with NMP in the workplace; Start Printed Page 51156

(B) The exposure controls selected based on feasibility, effectiveness, and other relevant considerations;

(C) If exposure controls were not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented;

(D) Actions taken to implement exposure controls selected, including proper installation, maintenance, training or other steps taken;

(E) Description of any restricted area and how it is demarcated, and identification of authorized persons; and description of when the owner or operator expects potential direct dermal contact exposures;

(F) Regular inspections, evaluations, and updating of the exposure controls to ensure effectiveness and confirmation that all persons are implementing them as required;

(G) Occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes direct dermal contact with NMP and subsequent corrective actions taken during start-up, shutdown, or malfunctions to mitigate exposures to NMP; and

(H) Availability of the exposure control plan and associated records for potentially exposed persons.

ii. Workplace information and training. EPA is also proposing to require implementation of a training program in alignment with the OSHA Hazard Communication Standard ( 29 CFR 1910.1200 ). To ensure that potentially exposed persons in the workplace are informed of the hazards associated with NMP exposure, EPA is proposing to require that owners or operators of workplaces subject to the WCPP institute a training and information program for potentially exposed persons and assure their participation in the training and information program. As part of the training and information program, the owner or operator would be required to provide information and comprehensive training in an understandable manner ( i.e., plain language), considering factors such as the skills required to perform the work activity and the existing skill level of the staff performing the work, and in multiple languages as appropriate ( e.g., based on languages spoken by potentially exposed persons) to potentially exposed persons. This information and training would have to be provided prior to or at the time of initial assignment to a job involving potential exposure to NMP. In alignment with the OSHA Hazard Communication Standard, owners and operators would be required to provide information and training to all potentially exposed persons that includes (A) the requirements of the NMP WCPP and how to access or obtain a copy of the requirements of the WCPP; (B) the quantity, location, manner of use, release, and storage of NMP and the specific operations in the workplace that could result in NMP exposure; (C) principles of safe use and handling of NMP in the workplace, including specific measures the owner or operator has implemented to prevent direct dermal contact with NMP, such as work practices and PPE used; (D) the methods and observations that may be used to detect the presence or release of NMP in the workplace (such as visual appearance or odor of NMP when being released, etc.); and (E) the health hazards associated with exposure with NMP. In addition to providing training at the time of initial assignment to a job involving potential exposure to NMP, and in alignment with the OSHA General Industry Standard for Beryllium ( 20 CFR 1910.1024 ), which includes an annual retraining provision, owners and operators subject to the NMP WCPP would be required to re-train each potentially exposed person annually to ensure they understand the principles of safe use and handling of NMP in the workplace. Owners and operators would also need to update the training as necessary whenever there are changes in the workplace, such as new tasks or modifications of tasks; in particular, whenever there are changes in the workplace that increase exposure to NMP or where potentially exposed persons' direct dermal contact exposure to NMP can reasonably be expected to occur. In alignment with the OSHA General Industry Standard for Methylene Chloride ( 29 CFR 1910.1052 ) owners and operators would need to retrain any exposed person if exposure to direct dermal contact of NMP, including vapor through skin exposure, occurs. To support compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP would be required to provide to the EPA, upon request, all available materials related to workplace information and training.

iii. Workplace participation. EPA encourages owners or operators to consult with potentially exposed persons on the development and implementation of exposure control plans and PPE. EPA is proposing to require owners or operators to provide potentially exposed persons, or their designated representatives, regular access to the exposure control plans and PPE program implementation and documentation. To ensure compliance in workplace participation, EPA is proposing that the owner or operator document the notice to and ability of any potentially exposed person to NMP direct dermal contact to readily access the exposure control plans, PPE program implementation, or any other information relevant to NMP exposure in the workplace. EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program.

iv. Recordkeeping. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to WCPP retain compliance records for five years. EPA is proposing to require records to include:

(A) the exposure control plan;

(B) PPE program implementation and documentation, including as necessary, respiratory protection and dermal protection used and related PPE training; and

(C) information and training provided to each person prior to or at the time of initial assignment and any re-training.

The owners and operators, upon request by EPA, would be required to make all records that are maintained as described in this unit available to EPA for examination and copying. All records required to be maintained by this unit could be kept in the most administratively convenient form (electronic or paper).

v. Compliance timeframes. With regard to the compliance timeframe for those occupational conditions of use that are subject to WCPP requirements, EPA is proposing to require that each owner or operator of a workplace subject to WCPP establish the process outlined in this unit within 12 months of publication of the final rule in the Federal Register for the private sector, and within 36 months of publication of the final rule in the Federal Register for Federal agencies and Federal contractors acting for or on behalf of the Federal government. For the private sector, EPA has no reasonably available information indicating this proposed compliance date of 12 months is not practicable for WCPP requirements, or that additional time is needed. However, EPA is concerned about the ability of certain departments and agencies of the Federal Government, as well as Federal contractors acting for or on behalf of the Federal Government, to comply with these timeframes. The importance of NMP to mission-critical Department of Defense and National Aeronautics and Space Administration (NASA) operations and overall military Start Printed Page 51157 readiness is discussed throughout this proposed rule, and detailed in Unit IV.A.6. While, for example, 29 CFR 1960 sets forth procedures and guidelines for ensuring that Federal workers are protected in comparable ways to their private sector counterparts, EPA believes that compliance with this proposed rulemaking would require increased and different preparations on the part of Federal agencies. For example, Federal agencies must follow procurement requirements which will likely result in increased compliance timelines. In addition, these requirements would require support in the Federal budget, which, for some agencies, is a multi-year process. Therefore, EPA is providing an additional two years for agencies of the Federal Government and their contractors, when acting for or on behalf of the Federal government, to comply with the WCPP.

EPA requests comment relative to the ability of owners or operators in the private sector to implement such processes within 12 months of publication of the final rule in the Federal Register, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. EPA also requests comment on whether the additional two years provided for agencies of the Federal Government and their contractors, when acting for or on behalf of the Federal government, to comply with the WCPP, should be provided more broadly to all entities complying with the WCPP.

EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

In contrast to the proposed non-prescriptive requirements of DDCC where regulated entities would select controls in accordance with the hierarchy of controls to comply with the parameters outlined in this unit, EPA is proposing that it is appropriate in certain circumstances to require specific prescriptive controls for certain occupational conditions of use where preventing direct dermal contact through implementation of a WCPP or a prohibition may not be practicable. EPA's description for how these requirements would address the unreasonable risk and the rationale for this regulatory approach is outlined in Units III.B.3 and V.A.

In the 2020 Risk Evaluation for NMP, and supplemental occupational risk calculations EPA identified certain prescriptive controls, such as product reformulation to limit concentration of NMP in certain products that, in combination with PPE, would reduce exposures from NMP enough to address the unreasonable risk (Ref. 37). Therefore, EPA is proposing to require specific prescriptive controls for these occupational uses of NMP, as described in this unit. The following requirements would apply to the following conditions of use:

• A concentration of NMP no greater than 45% in formulated products, with requirements for appropriate dermal PPE, and any NIOSH Approved® air-purifying respirator equipped with organic vapor cartridges or canisters (minimum APF 10) for:

—Processing—incorporation into articles in paint additives and coating additives in transportation equipment manufacturing;

—Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation;

—Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail trade; and

—Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives and two component glues and adhesives including some resins.

• A concentration of NMP no greater than 30% in formulated products, with requirements for appropriate dermal PPE, and any NIOSH Approved® air-purifying respirator equipped with organic vapor cartridges or canisters; any NIOSH Approved® powered air-purifying respirator equipped with NIOSH Approved® organic vapor cartridges; or any NIOSH Approved® continuous flow supplied air respirator equipped with a hood or helmet (minimum APF 25) for the industrial and commercial use in paints, coatings, and adhesive removers.
• A concentration of NMP no greater than 5% with requirements for appropriate dermal PPE for the industrial and commercial use in ink, toner, and colorant products in printer ink.
• A concentration of NMP no greater than 1% with requirements for appropriate dermal PPE for the industrial and commercial use in soldering materials.

This unit describes proposed requirements for concentration (or weight fraction) limits, appropriate dermal PPE, and respirator types with additional requirements proposed for recordkeeping. This unit also describes compliance timeframes for these proposed requirements.

EPA is proposing to prohibit the import, processing, distribution in commerce, or use of the NMP-containing products for the conditions of use listed in this unit with a concentration greater than those listed for each condition of use. Specifically, EPA proposes that processors, or product formulators, would not be permitted to formulate products for the conditions of use listed in in this unit with a concentration of NMP greater than specified in this unit. Similarly, importers of formulated products would be prohibited from importing products for the conditions of use listed in this unit with a concentration of NMP greater than specified in this unit. Entities distributing in commerce products containing NMP would be prohibited from distributing any products for the conditions of use listed in this unit with a concentration of NMP greater than specified in this unit.

To reduce exposures in the workplace and address the unreasonable risk of injury to health from NMP identified for the occupational uses listed in this unit, EPA is proposing both a concentration limit requirement and PPE requirement. Each owner or operator of a workplace who imports, processes, or industrially and commercially uses NMP under the conditions of use listed in this unit would be responsible for compliance with the requirements outlined in this unit. Specifically, concentrations of NMP in products used for the conditions of use listed in this unit would not be permitted to exceed the listed concentrations, and owners or operators would be responsible for ensuring requirements for the specified PPE and PPE program laid out in Unit IV.A.3.c. are met.

EPA is proposing to require appropriate dermal PPE, including impermeable gloves and protective clothing, in combination with comprehensive training for tasks with NMP. In selecting and providing appropriate dermal PPE and providing PPE training, owners and operators Start Printed Page 51158 would be required to follow the PPE program and dermal protection requirements laid out in Unit IV.A.3.c. Unlike DDCC, this proposed provision would not require owners and operators to use elimination, substitution, engineering controls, and administrative controls, prior to relying on PPE, as a means of controlling exposures in accordance with the hierarchy of controls. EPA encourages owners and operators to consider the hierarchy of controls, but is only proposing to require specific respiratory PPE for several of the conditions of use listed in this unit, in combination with comprehensive training for tasks with NMP. In providing the specified respirators and training, owners and operators would be required to administer a respiratory protection program with worksite-specific procedures and elements for required respirator use in accordance with 29 CFR 1910.134(a) through (l) , except 29 CFR 1910.134(d)(1)(iii) and (d)(3)(i)(B) , for proper respirator use, maintenance, fit-testing, medical evaluation, and training. EPA is proposing that the owner or operator must ensure that all cartridges, and canisters used in the workplace are labeled and color coded with the NIOSH approval label and that the label is not removed and remains legible. 29 CFR 1910.134(d)(3)(iii) , which EPA is proposing to cross-reference, requires either the use of respirators with an end-of-life service indicator certified by NIOSH for the contaminant, in this case NMP, or implementation of a change schedule for canisters and cartridges that ensures that they are changed before the end of their service life. EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA's General Industry Standard for 1,3-Butadiene ( 29 CFR 1910.1051(h) ), or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA's General Industry Standard for Benzene ( 29 CFR 1910.1028(g)(3)(D) ). Owners and operators would also be required to follow the PPE program laid out in Unit IV.A.3.c.

To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace that would be subject to the prescriptive controls described in this unit (including product formulators) retain compliance records for five years. EPA is proposing to require records to include:

(1) Documentation identifying implementation of and compliance with the concentration limits described in this unit;

(2) Dermal protection used by each potentially exposed person, as described in this unit;

(3) Respiratory protection used by each potentially exposed person, as described in this unit; and

(4) PPE program implementation.

The owners and operators, upon request by EPA, would be required to make all records that are maintained as described in this unit available to EPA for examination and copying in accordance with EPA requirements. All records required to be maintained by this unit could be kept in the most administratively convenient form (electronic or paper). EPA is requesting public comment on whether additional documentation should be required to further support compliance and enforceability of the proposed regulatory requirements ( e.g., requirements for labels or SDS identifying percent of NMP within a product, or downstream notification of these proposed requirements for concentration limits and PPE, or other information that would be made available to industrial and commercial users to indicate compliance with the concentration limits).

EPA is proposing to stagger the compliance dates for the proposed prescriptive controls described in this unit, such that the requirements would come into effect in 12 months for importers, 15 months for processors, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), 24 months for industrial and commercial users after the publication date of the final rule. When proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with NMP exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be impacted, or that additional time is needed for product reformulation and PPE training. However, EPA requests comment on whether additional time is needed, other concentrations are required, or if there are available substitutes for this application. As discussed in Unit IV.A.1, EPA recognizes that recent proposed rulemakings under TSCA section 6(a) have received public comments requesting longer compliance timeframes. For NMP, EPA believes that the proposed compliance timeframes for the prescriptive controls described in this unit may present fewer compliance challenges than those described by commenters on other rules. For example, for NMP, it may be more feasible to more rapidly reformulate products containing NMP or to institute workplace controls to prevent direct dermal contact (in contrast to the challenges of reducing inhalation exposures). EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

In the 2020 Risk Evaluation, EPA determined that consumer use of NMP in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants contributes to the unreasonable risk from NMP, due to risk of injury to health of consumers (Ref. 1). To address the unreasonable risk to consumers, EPA is proposing to require that import, processing, and distribution in commerce (including by retailers) of NMP and formulated NMP-containing products intended for consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants be limited to a concentration of NMP no greater than 45%.

As discussed in Units III.B.3. and V.A., based on consideration of the severity of the hazards of NMP in conjunction with the limited options available to address the identified unreasonable risk to consumers under TSCA section 6(a), EPA is proposing this concentration limit, supported by additional modeling using the methodology of the 2020 Risk Evaluation for NMP (Ref. 38). EPA is requesting public comment on whether additional documentation should be required to further support compliance and enforceability of the proposed regulatory requirements ( e.g., requirements for labels identifying the percent of NMP within a product or downstream notification of these proposed requirements for concentration limits).

Similar to the other compliance timeframes described in this unit, EPA is proposing to stagger the compliance dates for the proposed concentration limits described in this unit, such that the requirements would come into effect in 12 months for importers, 15 months Start Printed Page 51159 for processors, 18 months for distributing to retailers, 21 months for all other distributors (including retailers) after the publication date of the final rule. When proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with NMP exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be impacted, or that additional time is needed for product reformulation. However, EPA requests comment on whether additional time is needed, other concentrations are required, or if there are available substitutes for this application. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

For two conditions of use for which EPA is proposing prescriptive controls, EPA is aware of specific mission- or safety-critical uses for which the concentration limits EPA is proposing would negatively impact DOD and NASA, and for which technically and economically feasible safer alternatives that benefit health or the environment are not available. Based on the considerations described in this unit and Unit V.A.1.c.iii., and in accordance with TSCA section 6(c)(2), EPA is proposing that the WCPP be allowed for use of NMP at high concentrations by DOD, NASA, or their contractors within the following conditions of use:

• Industrial and commercial use in paints, coatings, and adhesive removers; and
• Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation.

For the reasons detailed in Unit V.A.1.c.iii., EPA is restricting the applicability of the WCPP for industrial and commercial use of high concentrations of NMP in paint, coating, and adhesive removal and paints and coatings. EPA is proposing that the conditions under which the WCPP could apply for this use would be: (1) the use of NMP for paints and coatings at a concentration greater than 45% and for paint, coating, and adhesive removers at a concentration greater than 30% by DOD, NASA, or their contractor(s) performing this work only for Federal agency projects would be limited to the mission-critical components on government-operated aerospace vehicles, vessels, and military weapons systems, including mission- or safety-critical components; (2) The use of NMP for paints and coatings at a concentration greater than 45% and for paint, coating, and adhesive removal at a concentration greater than 30% would have to be conducted at Federal installations, at Federal industrial facilities, or at Federal contractor facilities performing paint or coating work, or paint, coating, or adhesive removal work only for DOD and NASA projects; (3) any of the previously listed Federal agencies or their contractors who use NMP in paints and coatings at a concentration greater than 45% or for paint, coating, or adhesive removal at a concentration greater than 30% must comply with the WCPP requirements described in Unit IV.A.3., and (4) DOD, NASA, or their contractors who use NMP in paints and coatings at a concentration greater than 45%, or for paint, coating, or adhesive removal at a concentration greater than 30% must provide a certification of their compliance with the conditions of this use.

To ensure that any products that exceed the concentration limits that EPA has identified as necessary for addressing the unreasonable risk for other industrial and commercial users do not become available for widespread commercial use, EPA is proposing to require DOD, NASA, or their contractors who use NMP in paints and coatings at a concentration greater than 45%, or for paint, coating, or adhesive removal at a concentration greater than 30% must provide a certification of their compliance with the conditions of the applicability of the WCPP for this use. Specifically, each entity must provide a self-certification describing: (1) their status as either DOD or NASA, or a contractor to DOD or NASA; and (2) their implementation of and compliance with the WCPP to purchase and use NMP-containing products that exceed the concentration limits for other industrial and commercial users described in this unit.

EPA is proposing the following self-certification statement:

I certify each of the following statements under penalty of law. This document was prepared under my direction and supervision. The facility in which this product will be used is a Federal installation, a Federal industrial facility, or a Federal contractor facility performing paint or coating work, or paint, coating, or adhesive removal work for DOD and NASA projects. This facility's implementation of the Workplace Chemical Protection Program (WCPP) for NMP was evaluated by qualified personnel and that this facility has implemented and complies with the WCPP for NMP. Based on my inquiry of the person or persons who manage the facility and/or those persons directly responsible for implementing the NMP WCPP, and to the best of my knowledge and belief, the facility is implementing the NMP WCPP, including the exposure control plan and other proper documentation of the actions taken is available at the facility upon request. I am aware that there are significant penalties, including the possibility of civil penalties for failing to comply with these requirements and criminal penalties, including fines and imprisonment, for knowingly failing to comply with these requirements. I understand that this certification shall serve as a certification that this facility will properly implement and comply with the WCPP for NMP consistent with the applicable regulatory timelines.

EPA realizes that some facilities may not engage in the NMP uses listed in this unit at the time this proposed rule is finalized. Owners or operators that may wish to purchase NMP after publication of the final rule would still be required to submit the self-certification statement to the distributor from whom NMP was initially purchased to purchase NMP, including certifying that the facility for which NMP is being purchased will implement and comply with the WCPP. EPA is also proposing that distributors review the self-certification statement to ensure it is appropriately completed to include the owner or operator's and the facility's information, as outlined in this unit. EPA is also proposing to require distributors of NMP to retain invoices, including the name of the facility purchasing NMP, name of the owner or operator who is self-certifying, date of sale, and quantity of NMP purchased. EPA is proposing that the distributors and owners or operators maintain and retain the self-certification statement and related invoices(s) in the most administratively convenient form (electronic or paper) and retain the statement(s) and supporting documentation for five years.

EPA recognizes that for DOD, NASA, or their contractors performing work for their projects to use paints and coatings and paint, coating, and adhesive removers containing NMP at concentrations greater than those proposed for other industrial and commercial use, the upstream processing (or formulation) and distribution in commerce of those products should also be allowed to Start Printed Page 51160 continue. For these reasons, EPA proposes that processing and distributing in commerce NMP for paints and coatings at a concentration greater than 45%; and for paint, coating, and adhesive removal at a concentration greater than 30% would adhere to the following conditions: (1) Entities processing NMP for paints and coatings at a concentration greater than 45% or for paint, coating, and adhesive removal at a concentration greater than 30% must comply with the WCPP requirements described in Unit IV.A.3.; (2) Entities processing or distributing NMP for paints and coatings at a concentration greater than 45% or for paint, coating, and adhesive removal at a concentration greater than 30% must provide downstream notification of the restrictions on use of these products by adding the following language to sections 1(c) and 15 of the SDS:

After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] this chemical/product cannot be distributed in commerce to retailers for any use. After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], this chemical/product is and can only be distributed in commerce or processed for the following purposes: paints and coatings or paint, coating, or adhesive removal by the Department of Defense (DOD), the National Aeronautics and Space Administration (NASA), or their contractors, at Federal installations, Federal industrial facilities, or at Federal contractor facilities performing work only for DOD and/or NASA projects.

and (3) Entities processing or distributing these products in commerce would be required to provide a label that meets the requirements outlined in IV.A.2. that provides similar language to the SDS:

This product contains n-methylpyrrolidone (NMP), a chemical determined by the Environmental Protection Agency to present unreasonable risk of injury to health under of the Section 6 of the Toxic Substances Control Act, based on developmental and reproductive effects. This product containing NMP is restricted for use under 40 CFR part 751, subpart C . This product is restricted for sale and can only be used by the Department of Defense (DOD), the National Aeronautics and Space Administration (NASA), or their contractors, at Federal installations, Federal industrial facilities, or at Federal contractor facilities performing work only for DOD and NASA projects.

These entities would be subject to the proposed general recordkeeping requirements discussed in Unit IV.A.7., the WCPP recordkeeping requirements discussed in Unit IV.A.3.d.iv., and requirements to maintain records that demonstrate compliance with these requirements.

EPA requests comments on all aspects of the proposed applicability of the WCPP to these narrowly described uses of higher concentration NMP in paint, coating, and adhesive removal and paints and coatings. EPA also requests comment on whether entities other than DOD, NASA or its contractors also require high concentration NMP and, if so, the extent to which lack of availability of high concentration NMP could impact their operations or pose potential challenges to the supply chain. Finally, EPA is requesting comment on whether EPA should also require reporting to EPA during purchasing of NMP for these specific uses by DOD, NASA, or their contractors and if requiring reporting could support of enforcement and compliance assurance with this rulemaking by further assuring that distribution of these high concentration NMP products for these uses is limited to DOD, NASA, and their contractors, and if such requirements would impose significant administrative burdens in addition compliance with the WCPP.

In addition to the recordkeeping requirements for the WCPP and prescriptive controls outlined in this unit, for conditions of use that would not otherwise be prohibited under this proposed regulation, EPA is also proposing that manufacturers, processors, distributors, and commercial users maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation and maintain such records for a period of 5 years from the date the record is generated. EPA is proposing that this requirement begin at the effective date of the rulemaking (60 days following publication of the final rule in the Federal Register ). Recordkeeping requirements would ensure that owners or operators can demonstrate compliance with the regulations if necessary. EPA may require more, less, or different documentation in the final rule based on consideration of public comments.

For conditions of use that would not otherwise be prohibited under this proposed regulation, EPA is proposing that manufacturers (including importers), processors, and distributors, excluding retailers, of NMP and NMP-containing products provide downstream notification of the prohibitions through the SDS required by OSHA under 29 CFR 1910.1200(g) by adding the following language to sections 1(c) and 15 of the SDS:

AFTER [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], this chemical/product cannot be distributed in commerce or processed with a concentration of NMP greater than 0.1% by weight for the following purposes: Processing incorporation into articles in lubricants and lubricant additives in machinery manufacturing; Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greases; Industrial and commercial use in metal products not covered elsewhere and lubricant and lubricant additives including hydrophilic coatings; Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removers; and Industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents.

The intention of downstream notification is to spread awareness throughout the supply chain of the restrictions on NMP under TSCA and to provide information to commercial end users about allowable uses of NMP.

To provide adequate time to update the SDS and ensure that all products in the supply chain include the revised SDS, EPA is proposing a 2-month period for manufacturers and a 6-month period for processors and distributers, excluding retailers, to implement the proposed SDS changes following publication of the final rule.

EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this unit.

As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA must consider and publish a statement based on reasonably available information with respect to the reasonably ascertainable economic consequences of the rule, including consideration of the costs and benefits and the cost effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions considered by the Agency. This unit includes a description of the primary alternative regulatory action considered by the Agency. An overview of the proposed regulatory action and alternative regulatory action for each condition of use is in Unit IV.C.

The primary alternative regulatory action described in this document and Start Printed Page 51161 considered by EPA combines a WCPP and prescriptive controls to address the unreasonable risk from NMP. While in some ways it is similar to the proposed regulatory action, the primary alternative regulatory action described in this document differs from the proposed regulatory action by providing for a WCPP, including DDCC, for some conditions of use that would be prohibited or have prescriptive controls under the proposed regulatory action. Additionally, the primary alternative regulatory action considered includes the prohibition of one industrial and commercial use and the manufacturing, processing, and distribution in commerce for one consumer use, all of which would be required to have prescriptive controls under the proposed regulatory action. The primary alternative regulatory action would not include restrictions on the container size of consumer products that may feasibly be used for commercial purposes.

The primary alternative regulatory action also includes longer compliance timeframes for implementation of WCPP and prescriptive controls, as described in this unit. EPA requests comment on this alternative regulatory action and whether any elements of this alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A.

The primary alternative regulatory action described in this document includes a WCPP, including DDCC, for the following conditions of use:

• Processing as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative processing;
• Processing incorporation into a formulation, mixture or reaction product in multiple industrial sectors;
• Processing incorporation into articles as a solvent (which becomes part of a product formulation or mixture) including in textiles, apparel and leather manufacturing;
• Processing incorporation into articles in other sectors, including in plastic product manufacturing;
• Processing incorporation into articles in paint additives and coating additives in transportation equipment manufacturing;
• Processing repackaging in wholesale and retail trade;
• Processing in recycling;
• Industrial and commercial use in paints, coatings, and adhesive removers;
• Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation;
• Industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in electronic parts manufacturing;
• Industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in semiconductor manufacturing;
• Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail trade;
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing;
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing for use in semiconductor manufacturing;
• Industrial and commercial use in ink, toner, and colorant products in printer ink;
• Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing in oil and gas drilling, extraction and support activities, and in functional fluids (close systems);
• Industrial and commercial use in soldering materials;
• Industrial and commercial use in laboratory chemicals;
• Industrial and commercial uses in lithium ion battery manufacturing;
• Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removers; and

As described in Unit V.A., EPA proposed prohibiting or requiring prescriptive controls for some uses, and WCPP requirements for the other conditions of use, because of uncertainties regarding:

(i) The feasibility of implementing workplace safety control measures in open systems or when worker activities require manual application or removal of NMP or NMP-containing products;

(ii) availability of alternatives; or (iii) whether the use is ongoing or phased out. In this unit, EPA describes considerations for the primary alternative regulatory action. EPA requests comment on the ways in which NMP may be used in these conditions of use, including whether activities may take place in a closed system and the degree to which users of NMP in these sectors could successfully implement a WCPP (including DDCC) and ancillary requirements described in Unit IV.A. EPA is also requesting comment on whether any of the uses listed in this unit should be prohibited instead of a WCPP, or if there are other factors like reduced concentration limits or limited access that could address the unreasonable risk.

Under the primary alternative regulatory action, the WCPP would take effect 6 months later than under the proposed regulatory action. Regulated entities would be required to implement the WCPP requirements as described in Unit.IV.A.2. within 18 months after date of publication of the final rule in the Federal Register. EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A.

As noted in this unit, for some conditions of use, both the proposed regulatory action and primary alternative regulatory action would result in the condition of use falling under the NMP WCPP. EPA emphasizes that for those conditions of use, the primary alternative regulatory action includes a different timeline for implementation of the WCPP, in comparison to the proposed regulatory action. As discussed in more detail in Unit V.A., for those conditions of use, EPA also considered other regulatory approaches available under TSCA section 6(a). However, EPA found that none of these other regulatory Start Printed Page 51162 approaches would address the unreasonable risk.

Where EPA has determined that a chemical substance presents unreasonable risk under TSCA section 6(b)(4), EPA must undertake rulemaking to “apply one or more of the [TSCA section 6(a)(1) through (7)] requirements to such substance . . . to the extent necessary so that the chemical substance . . . no longer presents such risk.” TSCA section 6(a). “In proposing and promulgating [such] a rule,” EPA must “consider and publish a statement based on reasonably available information with respect to . . . the reasonably ascertainable economic consequences of the rule, including consideration of . . . (II) the costs and benefits of the proposed . . . regulatory action and of the [one] or more primary alternative regulatory actions considered by [EPA]; and (III) the cost effectiveness of the proposed regulatory action and of the [one] or more primary alternative regulatory actions considered by [EPA].” EPA interprets this to mean that Congress intended this “primary alternative regulatory action” to be another regulatory option under TSCA section 6(a)(1) through (7) that would meet the requirements of TSCA section 6(a) and address the unreasonable risk identified under TSCA section 6(b)(4) “to the extent necessary so that the chemical substance . . . no longer presents such risk.” Here, the proposed regulatory action is comprised of a mix of proposed options under TSCA section 6(a), each directed at specific conditions of use and with specified timeframes for compliance. The primary alternative regulatory options considered by the Agency would adjust the overall mix of TSCA section 6(a) requirements, including compliance timeframes, resulting in a proposed regulatory action that is more restrictive in some ways and less restrictive in others. For conditions of use where both the proposed option and the primary alternative regulatory option are both variations of the NMP WCPP, the options are distinct because implementing the WCPP on differing timetables under TSCA section 6(d) would result in a different mix of regulatory options with different costs, benefits, and cost effectiveness than the proposed regulatory action.

The primary alternative regulatory action considered by EPA and described in this document would prohibit the manufacturing, processing, and distribution in commerce, and use for the industrial and commercial use and prohibit the manufacture, processing, and distribution of NMP for consumer use for the following conditions of use:

• Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives and two component glues and adhesives including some resins; and
• Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants.

As discussed in Units III.B.3. and V.A., based on consideration of the severity of the hazards of NMP in conjunction with the limited options available to adequately address the identified unreasonable risk to consumers under TSCA section 6(a), EPA is proposing to address the contributions to the unreasonable risk from the consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants, by prohibiting the manufacturing (including import), processing, and distribution in commerce of NMP for this consumer use, and upstream industrial and commercial use to remove NMP and these products containing NMP from the market, thereby eliminating this consumer use. The alternative regulatory action differs from the proposed regulatory action in that, under the alternative regulatory action, EPA would prohibit the use of NMP in the conditions of use listed in this unit, rather than the proposed action to limit the concentration of NMP in the formulations for these uses and require PPE in the industrial and commercial use.

Regarding compliance timeframes, the alternative regulatory action for a prohibition of the uses described in this unit would follow the compliance timeframe for the proposed regulatory actions for a prohibition. Under the alternative action, compliance dates for the prohibition would be staggered such that the prohibitions would come into effect in 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users after the publication date of the final rule in the Federal Register . With regard to the compliance timeframe for the prohibitions on manufacturing, processing, and distribution in commerce for consumer use, under the alternative regulatory action, prohibitions as described in this unit would take effect in 12 months for manufacturers, 15 months for processors, 18 months for distributing to retailers and 21 months for all other distributors (including retailers) after the publication date of the final rule.

Table 1 presents a side-by-side summary of the proposed regulatory action and the primary alternative regulatory action for each condition of use. The purpose of this table is to succinctly convey to the public the major differences between the proposed regulatory action and the alternative regulatory action; as such the actions in each column are truncated and do not reflect all the details of the proposed and alternative regulatory actions, including differences in timeframes. The proposed and alternative regulatory actions are described more fully in Units IV.A. and B.

Table 1—Overview of Proposed Regulatory Action and Alternative Regulatory Action by Conditions of Use

Condition of useActionSubcategoryProposed regulatory actionPrimary alternative actionDomestic manufactureNMP WCPPNMP WCPP.ImportNMP WCPPNMP WCPP.Processing as a reactant/intermediate in plastic material and resin manufacturing and other non-incorporative processingNMP WCPPNMP WCPP.Processing incorporation into formulation, mixture or reaction products in multiple industrial sectors, including, but not limited to:NMP WCPPNMP WCPP.• Adhesives and sealant chemicals in adhesive manufacturing;Start Printed Page 51163• Anti-adhesive agents in printing and related support activities;• Paint additives and coating additives in paint and coating manufacturing; and print ink manufacturing;• Processing aids not otherwise listed in plastic material and resin manufacturing;• Solvents (for cleaning or degreasing) in non-metallic mineral product manufacturing; machinery manufacturing; plastic material and resin manufacturing; primary metal manufacturing; soap, cleaning compound and toilet preparation manufacturing; transportation equipment manufacturing; all other chemical product and preparation manufacturing; printing and related support activities; services; wholesale and retail trade;• Surface active agents in soap, cleaning compound and toilet preparation manufacturing;• Plating agents and surface treating agents in fabricated metal product manufacturing;• Solvents (which become part of product formulation or mixture) in electrical equipment, appliance and component manufacturing; other manufacturing; paint and coating manufacturing; print ink manufacturing; soap, cleaning compound and toilet preparation manufacturing; transportation equipment manufacturing; all other chemical product and preparation manufacturing; printing and related support activities; wholesale and retail trade;• In oil and gas drilling, extraction and support activities; plastic material and resin manufacturing; services.Processing incorporation into articles in lubricants and lubricant additives in machinery manufacturingProhibitionNMP WCPP.Processing incorporation into articles in paint additives and coating additives in transportation equipment manufacturingPrescriptive controls (45% CL+PPE)NMP WCPP.Processing incorporation into articles as a solvent (which become part of product formulation or mixture), including in textiles, apparel and leather manufacturingNMP WCPPNMP WCPP.Processing incorporation into articles in other sectors, including in plastic product manufacturingNMP WCPPNMP WCPP.Processing by repackaging in wholesale and retail tradeNMP WCPPNMP WCPP.Processing by recyclingNMP WCPPNMP WCPP.Industrial and commercial use in paints, coatings, and other adhesive removersPrescriptive controls  (30% CL+PPE)NMP WCPP.Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparationPrescriptive controls  (45% CL+PPE)NMP WCPP.Industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in electronic parts manufacturingNMP WCPPNMP WCPP.Industrial and commercial use in paint additives and coating additives in computer and electronic product manufacturing in semiconductor manufacturingNMP WCPPNMP WCPP.Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail tradePrescriptive controls (45% CL+PPE)NMP WCPP.Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturingNMP WCPPNMP WCPP.Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment appliance and component manufacturing in semiconductor manufacturingNMP WCPPNMP WCPP.Industrial and commercial use in ink, toner, and colorant products in printer ink and inks in writing equipmentPrescriptive controls (5% CL+PPE)NMP WCPP.Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing, in oil and gas drilling, extraction and support activities, and in functional fluids (closed systems)NMP WCPPNMP WCPP.Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives and two-component glues and adhesives including some resinsPrescriptive controls (45% CL+PPE)Prohibition.Industrial and commercial use in soldering materialsPrescriptive controls (1% CL+PPE)NMP WCPP.Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greasesProhibitionNMP WCPP.Industrial and commercial use in metal products not covered elsewhere, and lubricant and lubricant additives including hydrophilic coatingsProhibitionNMP WCPP.Industrial and commercial use in laboratory chemicalsNMP WCPPNMP WCPP.Industrial and commercial use in lithium ion battery manufacturingNMP WCPPNMP WCPP.Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removersProhibitionNMP WCPP.Start Printed Page 51164Industrial and commercial use in fertilizer and other agricultural chemical manufacturing, processing aids and solventsProhibitionNMP WCPP.Consumer use in paint and coating removers16 ounce container limit  + labelingWould not be regulated. Consumer use in adhesive removers16 ounce container limit  + labelingWould not be regulated. Consumer use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes16 ounce container limit  + labelingWould not be regulated. Consumer use in paint additives and coating additives in paints and arts and crafts paints16 ounce container limit  + labelingWould not be regulated. Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesivesConcentration Limit (45% CL)  Prohibition. Consumer use in automotive care products16 ounce container limit  + labelingWould not be regulated. Consumer use in cleaning and furniture care products, including wood cleaners and gasket removers16 ounce container limit  + labelingWould not be regulated. Consumer use in lubricant and lubricant additives, including hydrophilic coatings16 ounce (1 pint) container limit  + labelingWould not be regulated. DisposalNMP WCPPNMP WCPP.  WCPP is the proposed regulatory action for the industrial and commercial use in paint, coating, and adhesive removers for specific mission- or safety-critical uses by DOD, NASA, and their contractors.  WCPP is the proposed regulatory action for the industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation for specific mission- or safety-critical uses by DOD, NASA, and their contractors.  Prohibit manufacture, processing, and distribution in commerce for the consumer use.  There is no primary alternative action for the consumer uses that do not contribute to the unreasonable risk because similar commercial uses would not be prohibited; rather, the primary alternative action for the commercial uses would be WCPP.  Proposed container size restrictions are intended to prevent diversion of consumer products to commercial users.  This is the only condition of use for consumers that contributes to the unreasonable risk from NMP.

This unit describes how the considerations described in Unit III.B.3. were applied when selecting among the TSCA section 6(a) requirements to arrive at the proposed and alternative regulatory actions described in Unit IV.

EPA considered a prohibition as a regulatory option and is proposing it for certain conditions of use listed in Unit IV.A.1.a. Prohibition is the preferred option for occupational conditions of use where greater uncertainty exists relative to a sector's ability to comply with provisions of the proposed NMP WCPP, such as DDCC applications. This includes uncertainty regarding certain chemical users' ability to prevent direct dermal contact with NMP, in particular during use in open-systems or when worker activities require manual application or removal of NMP or a product containing NMP through rags, aerosols, spray applications, roll applicators, fingers, hands, or other materials. For example, the processing of NMP in lubricants and lubricant additives in machinery manufacturing includes the use of NMP in metal finishing operations. Depending on the type of substrate being prepared, this can include dip or immersion, spray, roll, or brush application. While some application methods may be automated, the extent of automated application versus use in an open sector with handheld and manual operations is unknown. EPA has received information from DOD about mission- or safety-critical uses of NMP at high concentrations in hot dip-tank cleaning, and the ability of DOD and its contractors to successfully implement the WCPP for hot dip-tank application of NMP for cleaning and coating removal (see Unit V.A.1.c.iii for more detail on this use). As described in Unit IV.A.6., EPA is proposing to require those owners and operators comply with a WCPP rather than a prohibition. However, as described in Unit IV.A.6., EPA is restricting the applicability of the use of high concentrations of NMP for paint, coating, and adhesive removal to DOD, NASA, and their contractors due to the exposure controls that DOD, NASA, and their contractors have in place, specifically for dip application.

While EPA has received some information from stakeholders regarding what may be a similar use of NMP, EPA does not have sufficient certainty that existing exposure controls by entities outside of DOD, NASA, or their contractors could successfully apply the WCPP for high concentrations of NMP in dip application such that the unreasonable risk is addressed. Specifically, EPA considered information from a stakeholder who described their use of NMP in industrial cleaning through soaking parts directly in NMP tanks (Ref. 39). Depending on the details of the dip application of NMP, this use may be considered industrial and commercial use of NMP in paint, coating, or adhesive removers; or industrial and commercial use of NMP in cleaning and degreasing. EPA notes that the 2020 Risk Evaluation for NMP identified three distinct occupational applications for NMP-containing cleaning products, including aerosol degreasing, dip degreasing and cleaning products, and wipe and spray-applied cleaning products. This stakeholder identified engineering controls including piped fill/drain systems, closed tank and exhaust, and other measures to reduce potential exposure to NMP including minimum operator time at the tank, employee training, and PPE recommended by an industrial hygienist. While EPA believes that this type of operation could successfully implement the NMP WCPP Start Printed Page 51165 with formulations with a high concentration of NMP, EPA has significant uncertainty regarding the extent to which these strict workplace controls, including prevention of direct dermal contact, are applied during all other cleaning and degreasing dip-tank applications. EPA is requesting comment on the workplace protection measures or exposure reduction measures typically applied during dip application of NMP, particularly dip degreasing and cleaning in hot or cold dip-tank immersion cleaning and degreasing, and dip application of NMP for adhesive, paint, or coating removal. EPA also requests comment on the typical tasks expected during hot and cold dip cleaning or coating removal operations, including manual or automated opening and closing of the dip tank, cleaning and maintenance, the use of new or repurposed vapor degreasing machines for immersion cleaning, or any other dip-tank or immersion cleaning and degreasing activities. EPA is interested in comments on the ability of users of high concentrations of NMP in dip applications to successfully implement a WCPP, the availability of alternative chemicals, and impacts of prohibiting NMP for the hot or cold dip-tank cleaning, degreasing, or removal of adhesives, paints, or coatings. Additionally, EPA requests comment on the number of firms who utilize hot or cold dip NMP for cleaning, degreasing, or removal of adhesives, paints, and coatings, the frequency of dip applications, and size of the dip vessel. EPA also requests comment on the types of engineering controls and any PPE use by firms who use NMP in hot or cold dip applications.

Similarly, EPA's uncertainties include the challenges related to PPE protection, which are discussed in more detail in Unit V.A.1.b., and which include how PPE may present vision problems, or cause communication problems, worker fatigue, and reduced work efficiency ( 63 FR 1152 , January 8, 1998) as well as consideration for that fact that not all workers may be able to wear PPE. Prohibition is the preferred option for occupational conditions of use where reasonably available information suggests minimal ongoing use or when feasible safer alternatives are reasonably available. The uncertainties related to whether users under certain conditions of use could comply with the requirements of an NMP WCPP, combined with the severity of the risks of NMP, the prevalence of alternative processes and products (Unit V.B.), and in some cases reasonably available information indicating a use is no longer ongoing (Refs. 4, 5), has led EPA to propose prohibitions for several industrial and commercial uses, and the upstream manufacturing (including import), processing, and distribution in commerce for those uses.

For example, EPA expects that for the use of NMP in fertilizers, compliance with the WCPP would present challenges and notes that alternatives have been identified for NMP. Therefore, EPA is proposing to prohibit this use of NMP. EPA's proposed prohibition of this condition of use is based on the uncertainties the agency has regarding the full nature and extent of the exposures and variety of work practices related to fertilizer use, and notes that the agency's concerns that implementing the WCPP or other strict workplace controls combined with the availability of alternatives leads to the proposed prohibition. In the primary alternative regulatory action, EPA has identified WCPP for this condition of use, and, as explained in more detail in Unit V.A.2, notes that, in some cases, regulated entities may be able to undertake more extensive risk reduction measures than EPA currently anticipates. EPA requests comment and supporting information on how NMP is used in the agricultural sector, including whether there are any other application types (such as aerosol application) besides liquid product containing NMP blended with solid fertilizer pellets. EPA requests comment on the degree to which entities using NMP in fertilizer manufacture or application may comply with the proposed WCPP requirements or similar stringent workplace controls for other conditions of use of NMP. EPA also requests comment on the workplace safety protocols in place during application, including expected exposure reductions during the use of NMP in fertilizer mixing and application, current engineering controls used, PPE usage and any standard hazard warnings or instructions in place. EPA requests comment on its conclusion that alternatives are available for NMP in all significant agricultural uses. Specifically, EPA requests comments on whether there are alternatives to NMP for solvents used in the production of fertilizers, as well as alternatives to the use of NMP to reduce the volatility of advanced fertilizer products by keeping nitrogen from volatilizing into the atmosphere before it can be absorbed into the soil. EPA also requests comment regarding the number of businesses and other entities that could potentially close as well as associated costs with a prohibition of NMP for the industrial and commercial conditions of use identified in Unit IV.A.1.a.

EPA determined prohibition would not be suitable for the remaining occupational conditions of use, such as processing as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative processing and several types of processing incorporation into a formulation, mixture, or reaction product; and industrial and commercial uses as a paint and coating additives in multiple applications or as a solvent, particularly for electronic component manufacturing applications, as a processing aid in petrochemical manufacturing, and as a laboratory chemical. EPA made this determination based on compelling reasons to not prohibit the activity and identification of a regulatory approach that would address the unreasonable risk. For example, prohibition may not be suitable for conditions of use that may have critical or essential uses for which no technologically and economically feasible safer alternative is available, or where EPA identified strict workplace controls could be implemented for these uses to address the unreasonable risk, as described in Unit IV.A.3.

Additionally, prohibition may not be suitable for conditions of use where alternative substances to NMP are at least as hazardous, in particular for other solvents undergoing risk evaluation and risk management under TSCA section 6. For example, methylene chloride is also in risk management under TSCA section 6 and has been determined to present unreasonable risk of injury to health. For industrial and commercial use in laboratory chemicals, NMP and methylene chloride are both used as a solvent although they are not drop-in substitutes for each other. In selecting among the TSCA section 6(a) requirements for the proposed approach for the use in laboratory chemicals, EPA considered whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute.

Given the severity of the risks identified in the 2020 Risk Evaluation for NMP, EPA proposes that prohibiting manufacture (including import), processing, and distribution in commerce of NMP for the industrial and commercial uses listed in Unit IV.A.1.a. is reasonable and necessary to eliminate the unreasonable risk of NMP.

To support implementation of the proposed prohibitions and restrictions, EPA also considered, and is proposing, Start Printed Page 51166 a de minimis level for products containing NMP to account for impurities that do not contribute to the unreasonable risk. EPA recognizes that the ability to test whether a product or entity would be regulated or not, by using a de minimis level, is beneficial and valuable to the regulated community.

EPA recognizes the importance of the OSHA Hazard Communication Standard ( 29 CFR 1910.1200 ), which sets a 0.1% de minimis level for chemicals that are carcinogens, and a limitation of 1% for chemicals that are not carcinogenic. As a matter of risk management policy, EPA believes that the widespread awareness by industrial and commercial workplaces of the de minimis levels in the OSHA Hazard Communication Standard would generally support successful implementation of the level EPA has identified. EPA notes that while NMP is not carcinogenic, EPA considered that it is identified as a substance of very high concern by the European Chemicals Agency and that Article 33(1) of the REACH Regulation details that businesses are only required to report when their products contain substances of very high concern that exceed 0.1% (Ref. 40). While NMP is not carcinogenic, this indicates a need for a de minimis level for NMP that would be lower than 1% under the OSHA Hazard Communication Standard.

EPA conducted an analysis using the methodology in the 2020 Risk Evaluation for NMP to estimate whether there is a weight fraction of NMP in products below which the most conservative use, applied through chronic application at the high-end exposure estimate of those products, respectively, and at various air concentrations would not contribute to the unreasonable risk from NMP (Ref. 41). EPA examined the supplemental analysis and found that an NMP concentration of 0.1% would achieve exposure concentrations that do not contribute to unreasonable risk up to an air concentration of 30 mg/m3. EPA also recognizes that an NMP concentration of 0.1% or less is likely to indicate an unintentional impurity in a product rather than a functional ingredient.

Based on these analyses, and to be protective of human health while also aligning with national and international regulations, EPA is proposing a de minimis level of 0.1%. As a result, EPA is proposing to exclude from prohibition and restrictions products containing NMP at or less than 0.1% by weight, as described in Unit IV.A. EPA has identified uncertainties with a concentration limit of 0.1% addressing the unreasonable risk. For example, the expected air concentration (as a time weighted average) may less accurately estimate inhalation exposures from some applications where exposures may differ from those predicted by the model ( e.g., as a result of higher NMP application rate or decreased ventilation). However, a concentration limit of 0.1% provides a margin of error to account for the uncertainties associated with the exposure model. EPA is requesting comment on the de minimis concentration limit of NMP in products or formulations. EPA emphasizes the agency's interest in aligning to the extent possible with the de minimis thresholds in the OSHA Hazard Communication Standard, while also noting that additional analytical work was conducted for NMP. EPA requests comment on whether de minimis thresholds should be proposed consistent with national and international regulations, or whether there may be instances where chemical-specific analyses is appropriate. Details of the proposed prohibitions and restrictions are described in more detail in Unit IV.A.

Some products in the Chemical Use Report were identified as intended for both commercial and consumer use. The 2020 Risk Evaluation for NMP incorporated these products into the occupational and consumer exposure scenarios, and EPA has determined that the industrial and commercial use contributes to the unreasonable risk for NMP due to worker exposure, while the consumer use of similar products does not contribute to the unreasonable risk (Ref. 1). In the 2020 Risk Evaluation for NMP, EPA considered currently available consumer products and their expected applications and evaluated exposures for consumers based on completion of a single project on a given day. EPA requests comment on if there are any NMP-containing consumer products that may require a more frequent or multiple day application, and if so, should EPA require additional restrictions for consumer products.

While EPA is not proposing to regulate the manufacture, processing, or distribution in commerce of these consumer products to address risks from the consumer use of such products, these consumer products are similar in composition and purpose to the commercial products that EPA does propose to prohibit and restrict. Therefore, EPA is also proposing regulations to prevent the consumer products that will remain available in the market from being diverted for commercial purposes. To reduce the potential of commercial users ( e.g., workers) accessing NMP-containing consumer products for use in any commercial conditions of use, EPA is proposing to prohibit importing, processing ( e.g., repackaging) and distribution—including to and by retailers—of NMP and NMP-containing products in containers larger than 16 ounces for the uses listed in Unit IV.A.2. EPA believes that limiting containers to typical consumer product sizes that would be inefficient for commercial use would prevent commercial purchase and use of these products. Consumer use is expected to result in acute exposures from a one-time use (resulting only in acute exposure and effects), while commercial use is expected to include repeated exposure from frequent use (resulting in acute and chronic exposure and effects). EPA believes that commercial users would be dissuaded from using consumer products if the container sizes are limited. Instead, potential commercial users would more likely select an alternative product, since it would be impractical to purchase the large number of smaller containers necessary for commercial use. EPA requests comment on the potential impacts to consumers and the consumer use of these products from a container size requirement.

EPA is also requesting comment on whether, rather than a container size restriction requirement, a maximum concentration limit for products containing NMP be required instead. EPA is aware of a range of concentrations of NMP in consumer products on the market (Ref. 1). If products in this range of concentrations of NMP were used in an occupational setting, they would contribute to the unreasonable risk from NMP (Ref. 2). EPA requests comment on the typical or effective concentration of NMP in the following consumer products: paint and coating removers, adhesive removers, paints and coatings, paint additives and coating additives in arts and crafts paint, automotive care products, cleaning and furniture care products, and lubricant and lubricant additives, and whether a maximum concentration of NMP could be identified that would allow the product to continue to be efficacious for consumer use, but that would not exceed the concentrations EPA has identified in Unit IV.A.1.e. for addressing the contribution of these types of products to unreasonable risk for workers. Start Printed Page 51167

Regarding industrial, commercial, and consumer uses of NMP, TSCA section 6(a)(2) provides EPA with the authority to prohibit or otherwise restrict the manufacture (including import), processing, or distribution in commerce of a substance or mixture “for a particular use” to ensure that a chemical substance no longer presents unreasonable risk. For this rule, EPA proposes that “for a particular use” includes industrial, commercial, and consumer uses more broadly, which encompasses all known, intended, and reasonably foreseen uses of NMP. Given the severity and ubiquitous nature of the risks identified in the 2020 Risk Evaluation for NMP for all industrial and commercial uses evaluated, and noting that those conditions of use evaluated in the Risk Evaluation encompass all known, intended, and reasonably foreseen uses of NMP, EPA proposes establishing requirements for an NMP WCPP for all occupational conditions of use except for those conditions of use which would be prohibited or subject to prescriptive controls. An NMP WCPP would include a combination of requirements to the extent necessary to address unreasonable risk driven by direct dermal exposures in the workplace. An NMP WCPP would encompass restrictions all occupational conditions of use except those which would be prohibited or subject to prescriptive controls, and could include provisions for a DDCC, and ancillary requirements to support implementation of these restrictions. While the NMP WCPP includes stringent requirements that would be necessary to address the unreasonable risk from NMP, EPA identified a relatively large number of conditions of use where the Agency expected, based on reasonably available information, an NMP WCPP could be successfully implemented because the dermal exposures can be more effectively controlled across this broad range of facilities engaging in a relatively large number of conditions of use.

i. DDCC requirements. For occupational conditions of use not otherwise proposed to be prohibited or subject to prescriptive controls, including but not limited to those listed in Unit IV.A.3., EPA considered including a requirement for DDCC in the NMP WCPP. DDCC, under the NMP WCPP, would be a process-based requirement to prevent direct dermal contact in the workplace by separating, distancing, physically removing, or isolating potentially exposed persons from direct handling of NMP or from contact with equipment or materials on which NMP may exist under routine conditions. DDCC is non-prescriptive, in the sense that it would not require a specific control to prevent direct dermal contact. Rather, DDCC would enable regulated entities to determine how to most effectively separate, distance, physically remove, or isolate potentially exposed persons from direct dermal contact with NMP based on what works best for their workplace, in accordance with the hierarchy of controls. In deciding whether DDCC would appropriately address the unreasonable risk driven by dermal exposures, EPA considered factors related to work activities that may make it difficult to eliminate direct dermal contact. Examples include work activities that may take place in open systems that require manual handling of NMP, such as application or removal of NMP or an NMP-containing product through rags, aerosols, spray guns, roll applicators, fingers, hands, or other materials or work activities that require a high range of motion or for some other reason create challenges for the implementation of dermal PPE.

EPA also considered whether exposures could be reduced in a manner aligned with the hierarchy of controls and considered the type of PPE that would be needed under the NMP WCPP to prevent direct dermal contact if elimination, substitution, engineering controls, and administrative controls are not sufficient to prevent direct dermal contact. The 2020 Risk Evaluation for NMP describes expected exposures with and without use of PPE; even if chemically resistant gloves are used in combination with basic workplace training and specific activity training for tasks where dermal exposure can be expected to occur, EPA found that dermal exposures would continue to pose risk concerns for most conditions of use. However, the 2020 Risk Evaluation for NMP identifies several uncertainties regarding the dermal exposures modeled. For example, the 2020 Risk Evaluation for NMP does not consider the frequency, type, and effectiveness of gloves or other types of PPE used or specific workplaces. In addition, the 2020 Risk Evaluation for NMP does not specify the specific activity training beyond procedure for glove removal and disposal (Ref. 1).

In consideration of the 2020 Risk Evaluation for NMP, including the uncertainties, EPA has preliminarily determined that preventing direct dermal contact to NMP through DDCC requirements, including requirements to reduce exposures in a manner aligned with the hierarchy of controls, workplace specific training, and, if necessary, dermal PPE which covers any exposed skin (including hands, legs, torso, and face), and PPE training, as described in Unit IV.A.3., for certain occupational conditions of use would address the contributions to unreasonable risk from dermal exposures from these conditions of use for potentially exposed persons.

ii. NMP WCPP. Taking into account these considerations, EPA is proposing that occupational conditions of use other than those proposed to be prohibited or subject to prescriptive controls (as listed in Units IV.A.1 and 4), including those listed in Unit IV.A.3., would be allowed to continue if regulated entities could ensure direct dermal contact is prevented, and other requirements are met in the NMP WCPP. In contrast to considerations indicating that it is unlikely that facilities within a condition of use could successfully implement WCPP, there are certain considerations that indicate that facilities engaging in a condition of use would likely be able to achieve effective risk management via WCPP. Based on reasonably available information, including monitoring data (Ref. 42), process descriptions, and information related to considerations described previously in this unit, EPA's confidence that requirements to prevent direct dermal contact can be implemented is highest in highly standardized and industrialized settings, such as where NMP is used in a closed system. For example, one of the conditions of use for which EPA is proposing a WCPP is processing of NMP as a reactant or intermediate in plastic and resin manufacturing and other non-incorporative processing. NMP use and exposure information submitted by industry indicates that controls may already be in place at some workplaces to prevent or reduce direct dermal contact with NMP, including enclosed transfer liquid lines, processing equipment, other engineering and administrative controls, and chemically resistant gloves (Ref. 43).

Another set of conditions of use for which EPA is proposing the WCPP is the industrial and commercial use of NMP in paint additives and coating additives and as a solvent (for cleaning or degreasing) in computer and electronic product manufacturing in semiconductor manufacturing and the industrial and commercial use of NMP in lithium ion battery manufacturing. EPA understands that most workplaces using NMP in semiconductor manufacturing and lithium ion battery manufacturing already have stringent Start Printed Page 51168 controls in place that reduce workplace exposures. As described in public comments and through engagement with the Semiconductor Industry Association (SIA), the Lithium Ion Cell Manufacturers' Coalition (LICMC), and individual companies, these manufacturing facilities use NMP in frequent, closed processes, where it does not present opportunity for human exposure and where NMP is completely removed from the final product (Refs. 42, 44). Semiconductor manufacturing stakeholders have described how, upon delivery by tote or tank truck at refineries, NMP is directly injected from a tote into a closed processing unit or transferred from a truck into a storage tank that is directly hooked up for direct injection in a closed system. Transfer procedures of NMP are performed pursuant to comprehensive written procedures under strict PPE guidelines including, when appropriate, respirators. Information submitted by SIA indicates that worker exposure is limited to chemical unloading and transfer procedures (Ref. 42). Information submitted by LICMC indicates that their members manufacturing facilities use engineering controls like automatic mixers, closed system piping and ventilation, and where direct contact with NMP is possible workers are provided powered air purifying respirators (APF 1000) with particulate/organic vapor cartridge, and NMP resistant gloves and boots, and other PPE as necessary including Tyvek suits, face shields, splash goggles, and latex inner gloves (Ref. 44).

While EPA understands that it is likely that the frequency and duration of exposure to NMP at semiconductor manufacturing facilities may be less than what was assumed in the risk evaluation, as described in this unit, EPA does not have any dermal monitoring data to confirm that NMP exposures are below the level modeled in the 2020 Risk Evaluation. Based on analysis in the 2020 Risk Evaluation for NMP describing expected exposures with and without use of PPE, EPA identified that even with direct dermal contact, PPE would not be sufficient to mitigate the unreasonable risk driven by dermal exposure from this condition of use. However, based on information received for this condition of use and reasonably available information, EPA believes that controls may already be in place to prevent or reduce direct dermal contact with NMP, such as using NMP in a closed system to limit exposures and implementing comprehensive written procedures with added PPE during transfer procedures.

For both of these conditions of use (processing as a reactant or intermediate in plastic and resin manufacturing and other non-incorporative processing and industrial and commercial use in semiconductor manufacturing), in the 2022 revised risk determination, EPA determined that exposures to workers drove the unreasonable risk, but exposures to ONUs did not. ONUs include supervisors, managers, and other employees that may be in the production areas but do not perform tasks that result in direct dermal contact with liquids. Additionally, the risk calculation results between worker unreasonable risk and ONU no unreasonable risk were significantly different. This suggests that, for these conditions of use, owners or operators must prevent direct dermal exposure to address the unreasonable risk, even though ONUs are not expected to be at the exposure source like workers. This information, together with other considerations previously described indicating stringent controls may already be in place, adds to EPA's confidence that facilities engaging in these two conditions of use could meet, and may in fact already be meeting, the WCPP requirements.

For NMP to be available for the downstream industrial and commercial uses that would continue under an NMP WCPP, it would need to be manufactured (including imported), processed, and distributed in commerce. Likewise, as long as NMP remains in use, it must also be disposed of. Therefore, EPA is proposing requirements to meet an NMP WCPP for manufacture (including import), certain processing conditions of use, and disposal, to allow for a continued supply chain for specified conditions of use while ensuring that workers are not subject to unreasonable risk from NMP as it moves throughout the supply chain.

Details of the proposed NMP WCPP, including DDCC, required implementation measures, requirements for demonstrating compliance and requirements for distributors, are described in more detail in Unit IV.A.3.

iii. Mission- or safety-critical uses of NMP by DOD and NASA. As described earlier in Unit IV.A.6., EPA is aware of specific mission- or safety-critical uses for which the concentration limits EPA is proposing would negatively impact DOD and NASA. EPA is proposing that the WCPP be allowed for use of NMP at high concentrations by DOD, NASA, or their contractors within two conditions of use. DOD and NASA have identified mission-critical uses for NMP in paints, coatings, and adhesive removal as well as in paints and coatings for ensuring readiness of aviation, including human-rated space vehicle hardware, and military vessels (Refs. 45). Based on reasonably available information to EPA, there are no technically and economically feasible alternatives to these products with high concentrations of NMP that benefit health or the environment. These uses are important to the military readiness of DOD's warfighting capability and the functionality paramount to ensuring national security. These uses are also important to NASA's space projects. Based on the existence of the current exposure reduction methods and EPA's expectation that DOD, NASA, and their contractors can comply with the WCPP for NMP in a way that addresses unreasonable risk, EPA is proposing WCPP with narrow applicability for these uses.

Regarding paint, coating, and adhesive removal, DOD has identified no alternatives for the use of products containing high concentrations of NMP for the removal of coatings from mission-critical corrosion-sensitive components on military aviation and vessels, including mission- or safety-critical components made of specialty metallic, nonmetallic, and composite materials. Similarly, NASA has identified mission-critical NMP-containing products that are integral to de-processing and necessary for removing a variety of coatings from various flight hardware and avionic components, without which mission risk would be increased. For both DOD and NASA, the NMP-containing products used are higher than the 30% concentration limits EPA is proposing as part of the prescriptive controls described in Unit IV.A.4. EPA has identified products for this use containing up to 70% NMP (Ref. 1) and DOD and NASA may use pure (neat) NMP for their mission-critical processes. Additionally, NMP has been used to meet required levels of performance of certified component parts by long-standing design and function specifications that are incorporated into contracts of a complex supply chain.

While EPA is not proposing to prohibit the industrial and commercial use of NMP for removal of paints, coatings, and adhesives, EPA is proposing to limit the concentration of NMP in those products to no more than 30% as described in Unit IV.A.4. This would result in impacts to aircraft and military vessels for military missions and space exploration. A concentration of 30% NMP may not be effective enough or capable of removing paints, Start Printed Page 51169 coatings, or adhesives on specialized equipment or parts. In many instances, only a highly concentrated amount of NMP would be capable of successfully performing this function. As an example, NMP and products containing a high concentration of NMP are used to break down and remove materials such as cured epoxies and thermoset resins from components that would be damaged by other means. This type of operation is conducted to refurbish and reuse delicate electronic components and, more critically, to deconstruct failed hardware to allow examination for root cause analysis. Failure analysis must be conducted to collect data needed to determine potential risks to hardware that relies on the failed component and to inform vehicle architecture and hardware design efforts. Information available to EPA indicates that, for NASA, using NMP often is the only way to break down these materials without also damaging the substrate used by NASA. EPA is not aware of similar uses of such high concentration of NMP by entities outside the Federal government.

DOD and NASA have described the equipment they use for the coating removal application, and the differences between their coating removal operations and the brush-on or pour-over methods used for coating removal through other commercial or consumer products. DOD has described how the temperature, pH, and other constituents of the solution used in what is described as a hot dip-tank create hazards, separate from NMP, which are managed in DOD or contractor facilities through separation and dedicated ventilation of the tanks (and, secondarily, worker PPE). Based on the existence of the current exposure reduction methods and EPA's expectation that DOD, NASA, and their contractors can comply with the WCPP for NMP in a way that addresses unreasonable risk, EPA is proposing WCPP with narrow applicability for these uses. Information available to EPA does not indicate that commercial users other than DOD or NASA use such high concentrations of NMP, or that they have a need for similar paints or coatings. By requiring prescriptive controls that provide for a concentration of NMP that includes one currently found on the market along with implementable work practices, EPA believes that use of NMP in paint and coating applications in commercial aviation, space travel, or uses similar to those described by DOD and NASA could continue without resulting in unreasonable risk.

Similarly, regarding paints and coatings, DOD and NASA have identified mission-critical items using products containing high concentrations of NMP in specialized coatings for military tactical equipment on military aviation and vessels and development and maintenance of component parts, including human-rated space vehicle hardware. For both DOD and NASA, the NMP-containing products used are higher than the 45% concentration limit EPA is proposing as part of the prescriptive controls described in Unit IV.A.4. One such coating is a polyimide coating used in fabrication of detectors to meet precise specifications for use by Federal Agencies in systems such as spacecraft, aircraft, balloons, rockets, and telescopes. This coating, which is 60% NMP, is critical to fabricating these detectors. Additionally, NMP has been used to meet required levels of performance of certified component parts by long-standing design and function specifications that are incorporated into contracts of a complex supply chain. While EPA is not proposing to prohibit the industrial and commercial use of NMP for paints and coatings, EPA is proposing to limit the concentration of NMP in these products to no more than 45%, as described in Unit IV.A.4. This may result in a coating ineffective for the specialized parts or processes used by DOD and NASA. In many instances only a higher concentration of NMP would be capable of successfully performing the necessary function. Additionally, information available to EPA indicates that application of these coatings typically includes very small quantities (less than 1 pound annually) under tightly controlled conditions, allowing for successful application of the WCPP and greater certainty that the unreasonable risk can be addressed in comparison to other situations in which coatings containing NMP may be applied. For these reasons, EPA is proposing WCPP with narrow applicability for these uses. As described earlier in this unit for paints and coatings, information available to EPA does not indicate that commercial users other than DOD or NASA use such high concentrations of NMP for paint, coating, or adhesive removal in these types of uses. By requiring prescriptive control that provides for a concentration of NMP that includes one currently found on the market along with implementable work practices, EPA believes that use of NMP in paint, coating, and adhesive removal in commercial aviation, space travel, or uses similar to those described by DOD and NASA could continue without resulting in unreasonable risk.

In the narrowly described uses by DOD and NASA for mission- and safety-critical uses, in the controlled environments operated by those agencies or their contractors, EPA expects it is possible for the unreasonable risk to be addressed by the WCPP. However, EPA does not have information to support that expectation for other commercial users of these products, including by entities other than DOD or NASA engaged in commercial aviation or space travel. To prevent widespread distribution of the products containing high concentration of NMP beyond DOD, NASA, and their contractors, EPA is proposing additional requirements, including self-certification, downstream notification, and recordkeeping. These requirements are detailed in Unit IV and would not significantly burden the entities processing, distributing, or using NMP for these highly specialized uses, while providing important enforcement and compliance tools. EPA is seeking comment on whether the WCPP, with no concentration limits, should apply to all users of NMP in paints and coatings, and paint, coating and adhesive removal, rather than narrowly to DOD and NASA.

Another requirement EPA considered to address unreasonable risk for occupational conditions of use was requiring specific controls prescribed by EPA, including concentration limits and PPE. In the 2020 Risk Evaluation for NMP, EPA identified that certain workplace controls could reduce exposures (Ref. 1). The prescriptive controls EPA considered (such as concentration limits and PPE) are based on information in the 2020 Risk Evaluation for NMP and supplemental analyses using methodology from the 2020 Risk Evaluation for NMP. In general, EPA does not prefer prescriptive controls as the primary method of risk management because of uncertainties about whether the prescriptive controls will be feasible for reducing exposures in all workplaces engaged in a condition of use and whether the prescriptive controls will be consistently or properly used. EPA understands that workplaces have unique processes and equipment in place and that varying levels of respiratory protection or dermal PPE may be needed for different workplaces. Additionally, as described in Unit III.A.1. and 2., EPA received input during required consultations and additional engagement that options that align with the hierarchy of controls ( i.e., elimination and substitution of hazards Start Printed Page 51170 in the workplace) should be preferred over prescriptive controls.

EPA also determined that certain prescriptive controls ( i.e., PPE) may not be able to eliminate unreasonable risk contributed by some conditions of use when used in isolation. In the 2020 Risk Evaluation for NMP, analysis of occupational exposure scenarios indicated that many conditions of use still posed risk concerns even with the application of PPE (Ref. 1). Because of the uncertainty regarding the feasibility of exposure reductions through engineering controls alone, EPA determined that an NMP WCPP, which would be accompanied in tandem with the implementation of engineering controls, administrative controls, and/or PPE as elements of the program, as appropriate, would more successfully reduce exposure so that the unreasonable risk is addressed. Additionally, relying primarily on PPE to reduce exposures does not consider other more protective controls in the hierarchy, including elimination, substitution, engineering controls, and administrative controls. For occupational conditions of use where compliance with the NMP WCPP is unlikely to be successful, in most cases prohibitions (rather than prescribed controls) would be more appropriate to ensure that NMP does not present unreasonable risk under the conditions of use.

However, based on the 2020 Risk Evaluation for NMP, EPA considered the industrial and commercial use in the uses listed in Unit IV.A.4.a. as viable candidates for prescriptive controls. These uses include the application of NMP-containing products that have been identified in a range of concentrations of NMP rather than requiring the use of pure NMP, and include application, such as brush or roll tasks where direct dermal contact may not be preventable. Therefore, EPA conducted additional analyses with the model used in the 2020 Risk Evaluation within the ranges identified for the NMP-containing products with and without PPE and determined the parameters required to address the unreasonable risk.

For the industrial and commercial use of NMP in ink, toner, and colorant products, and in soldering materials, EPA did not conduct additional modeling and used information in the 2020 Risk Evaluation for NMP. EPA modeled a range of expected concentration limits, as described in section 2.4 of the 2020 Risk Evaluation for NMP. When EPA modeled the lower bound of identified concentration of NMP in formulation at the central tendency without PPE, it did not contribute to the unreasonable risk to workers. Alternatively, when EPA modeled at the upper bound of identified concentration of NMP at the high-end without PPE it did contribute to the unreasonable risk to workers, but dermal PPE could mitigate the unreasonable risk to workers (Ref. 1). Therefore, EPA is proposing the lower bound concentration limit and dermal PPE to address the unreasonable risk and prevent product formulation with high concentration limits that were not assessed in the 2020 Risk Evaluation for NMP and could potentially contribute to the unreasonable risk.

For additional conditions of use, EPA's analysis in the 2020 Risk Evaluation for NMP indicated that for the uses identified in Unit IV.A.4.a. (not including the conditions of use ink, toner, and colorant products, and in soldering materials) there would still be risk concerns even if chemically resistant gloves are used in combination with specific activity training for tasks where dermal exposure can be expected to occur. However, as described earlier, the 2020 Risk Evaluation for NMP identifies several uncertainties regarding the use of the dermal exposures modeled. For example, the 2020 Risk Evaluation for NMP does not consider the frequency, type, and effectiveness of gloves or other types of PPE used in these specific conditions of use (Ref. 1). In consideration of the whole of the 2020 Risk Evaluation for NMP, including these uncertainties and EPA's supplemental risk calculations, EPA identified certain exposure controls, such as limits on the concentration of NMP in certain products in combination with requirements for specified respirators and appropriate dermal PPE use, that would reduce exposures to NMP enough to address the unreasonable risk (Ref. 37). For these specific conditions of use, where expected activities like spray, brush, or roll applications of NMP-containing products results in higher air concentration levels than those conditions of use listed in Unit IV.A.3., dermal PPE alone is not expected to address the unreasonable risk. In the supplemental risk calculations EPA evaluated whether dermal PPE alone, or in combination with respirators, either APF 10 or APF 25 would address the unreasonable risk and determined that the combination of the set concentration limits and specified inhalation and dermal PPE listed in Unit IV.A.4. would address the unreasonable risk. EPA is requesting comment on whether there are additional circumstances where specific PPE (including respirators) should be prescribed, as well as the appropriateness of the proposed respiratory protection requirements for these conditions of use as listed in Unit IV.A.4 and any impacts that the prescriptive use of respiratory protection may have on workplace operations.

EPA recognizes that these different conditions of use have different expected activities or application methods, such as spray application of a paint remover that results in a higher-than-average air concentration of NMP as compared to the roll-on application of ink that does not result in elevated air concentration of NMP. As a result, EPA is proposing four different combinations of concentration and PPE to account for the specific exposures expected while also allowing each of the conditions of use to remain efficacious.

EPA has preliminarily determined that preventing direct dermal contact with NMP through dermal PPE that covers any exposed skin and PPE training for the industrial and commercial uses listed in Unit IV.A.4. in combination with the proposed concentration limits would address the unreasonable risk from dermal exposure driven by these conditions of use for potentially exposed persons. EPA is requesting comment on whether preventing dermal contact with NMP through dermal PPE, training, and a concentration limit would adequately address the unreasonable risk from dermal exposures for these industrial and commercial use. For certain occupational conditions of use, prescribed engineering controls, administrative controls, and PPE were considered as part of the alternative regulatory action and are described in more detail later in this unit and in Unit IV.B.

EPA's approach for the consumer use of NMP in adhesives and sealants in glues and adhesives is similar to the prescriptive controls approach for certain occupational conditions of use, described earlier in this unit. For the consumer use listed in Unit IV.A.5., EPA proposes to allow the import, processing, and distribution in commerce of NMP for the consumer use of NMP in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants only in a concentration of up to 45% in formulated products for consumer use. In the 2020 Risk Evaluation for NMP, EPA identified certain product concentration limits for this consumer Start Printed Page 51171 condition of use, based on information in the 2020 Risk Evaluation for NMP and supplemental analyses using methodology from the 2020 Risk Evaluation for NMP. EPA understands that consumers have unique processes and are not expected to have exposure reduction equipment in place or consistently use any levels of respiratory protection or dermal PPE. Therefore, EPA calculated a concentration limit that did not present unreasonable risk even without the use of PPE.

EPA acknowledges that, for some of the occupational conditions of use that it is proposing to prohibit or require strict workplace controls, there may be some activities or facilities that could conceivably implement requirements under the NMP WCPP to prevent direct dermal contact with NMP. In some cases, they may be able to undertake more extensive risk reduction measures than EPA currently anticipates. Therefore, as a primary alternative regulatory action, described in Unit IV.B., EPA is considering and requesting comment on an NMP WCPP—including requirements to prevent direct dermal contact—for some conditions of use of NMP that would be prohibited or otherwise regulated under the proposed regulatory action. For those conditions of use that would be subject to the NMP WCPP under the alternative regulatory action, but not the proposed regulatory action, EPA was not able to identify reasonably available information such as monitoring data or detailed activity descriptions to indicate with certainty that relevant regulated entities for these conditions of use could mitigate identified unreasonable risk through an NMP WCPP. Due to this uncertainty, EPA is requesting comment on the alternative regulatory action and in particular the likelihood of successful compliance with an NMP WCPP, as described in Unit IV.A., for the conditions of use listed for the alternative regulatory action of NMP WCPP in Unit IV.B. EPA notes that the primary alternative regulatory action includes WCPP for additional commercial conditions of use, rather than prohibition, which removes the need for container size restrictions on similar consumer conditions of use, because the proposed container size restrictions are intended to prevent diversion of consumer products to commercial users.

EPA acknowledges that, for some of the occupational conditions of use that it is proposing prescriptive workplace requirements there may be some activities or facilities that could not conceivably implement the required concentration limits to reduce inhalation and dermal exposures to NMP. As part of the primary alternative regulatory action, EPA considered instead a prohibition for the industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives and two component glues and adhesives including some resins and upstream activities for the consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants. However, as summarized in this unit, EPA has uncertainty regarding the necessity of a prohibition for the use of NMP in these conditions of use if the unreasonable risk could be addressed through a combination of a concentration limit and PPE (dermal and inhalation) for relevant industrial or commercial uses, and with a corresponding concentration limit for consumer products with similar purposes and attributes. EPA is soliciting comment on prohibiting for these occupational conditions of use.

Details of the alternative regulatory action are described more in Unit IV.B.

Since it is unlikely that all industrial or commercial facilities with occupational exposures to NMP would be able to implement a WCPP or prescriptive controls, EPA also examined the extent to which a point-of-sale self-certification requirement to purchase and subsequently use NMP would further ensure that only facilities able to implement and comply with a WCPP or prescriptive controls are able to purchase and use NMP, and self-certify to that. Under a self-certification requirement, entities would submit a self-certification to the distributor each time NMP is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP or required prescriptive controls to control exposures to NMP; the self-certification would be signed and presented by a person authorized to do so by the facility owner or operator. Copies of the self-certification would be maintained as records by both the owner or operator and the distributor where NMP was purchased. While EPA is proposing to include a requirement for self-certification as part of the proposed narrow application of the WCPP for two commercial uses of NMP in paints and coatings and paint, coating, and adhesive removers, that narrowly tailored self-certification differs from a broader point-of-sale self-certification requirement that would be applicable to all commercial users of products containing NMP. The self-certification proposed for the narrow application of the WCPP relies on the adherence of a narrowly defined, highly-regulated group of users (DOD, NASA, or their contractors) performing work at clearly defined facilities for specific purposes on mission- or safety-critical components in compliance with the WCPP requirements described in Unit IV.A.3.

In contrast, a broader self-certification requirement would place requirements on large and diverse groups of users and distributors. Because of the number and types of entities where users can obtain NMP or NMP-containing products, EPA does not believe the added requirement and subsequent burden of a point-of-sale self-certification requirement for the use of NMP would be an effective tool for preventing facilities that may be unable to comply with the WCPP or prescriptive controls of this proposed rulemaking from accessing NMP or NMP-containing products. As such, EPA is not proposing a self-certification requirement as an additional component of the requirements for addressing the unreasonable risk of occupational exposures to NMP. However, EPA is requesting comment on whether to include a self-certification requirement for purchasing NMP or NMP-containing products. For example, EPA is interested in learning if, for distributors and retailers, such a self-certification requirement would provide greater certainty that any sale of NMP or NMP-containing products would be for uses that are not prohibited and are to a facility implementing the WCPP or required prescriptive controls.

EPA considered setting an ECEL as a regulatory action to address the unreasonable risk by inhalation and dermal exposures. Previously, based on a 2015 risk assessment (Ref. 17), EPA proposed a regulatory action to restrict the use of NMP in commercial and consumer paint and coating removers that included a co-proposed option to prohibit the use of formulations with NMP more than 35% by weight and require PPE; that action was later withdrawn (Refs. 46, 47). Within the PPE requirement, in 2017, EPA proposed to require certain authorized respirators or an ECEL value. The ECEL value was dependent on inhalation and dermal exposures and weight fraction of NMP in the product. This analysis was specific to the PBPK model used for NMP which accounts for simultaneous dermal and inhalation exposure. The Start Printed Page 51172 ECEL analysis calculated several variations in exposures and weight fractions, including 35%, 50%, and 60% NMP. At 60% NMP presented unreasonable risk to workers even with no air concentration exposure (Ref. 48). In the 2020 Risk Evaluation for NMP, EPA reanalyzed certain hazard information compared to the previous 2015 EPA Assessment, resulting in revised risk estimates in which an ECEL as an alternative to a respirator requirement would not be feasible to address the unreasonable risk for the industrial and commercial use of NMP in paints, coatings, and adhesive removers at 35% by weight NMP. The 2020 Risk Evaluation for NMP used a PBPK model that allowed EPA to evaluate aggregate exposures from simultaneous dermal, inhalation, and vapor-thorough-skin exposures associated with specific exposure scenarios (Ref. 1). The 2020 Risk Evaluation for NMP also compared the internal exposure to workers from dermal, inhalation, and vapor-through-skin pathways to the internal exposures to ONUs from inhalation and vapor-through-skin pathways. The results shows that the proportion of the exposure largely driving the unreasonable risk to workers and consumers is due to dermal contact with liquid NMP (Ref. 1) and addressing inhalation risks alone would not mitigate the unreasonable risk from NMP. Thus, EPA has not identified and is not proposing to set an ECEL for NMP. While a level could be set that would account for risk resulting from inhalation and vapor-through-skin (dermal exposure to vapor but not direct dermal contact with a liquid) exposures and the risk from direct dermal exposure at a specified weight fraction, the Agency is concerned an ECEL value would imply that inhalation is the primary route of exposure. Further, the 2020 Risk Evaluation identified a range of NMP weight fractions in the conditions of use, and most occupational uses of NMP require weight fractions much higher than 35%, or even 60%. As described in the 2017 NMP ECEL analysis, no ECEL value would mitigate the unreasonable risk when the weigh fraction is at or above 60%. Therefore, requirements to meet an ECEL would not address the unreasonable risk from dermal exposure.

Additionally, the previous proposed ECEL in 2017 was calculated for one condition of use and exposure scenario and accounted for the specific concentration limit EPA proposed for that condition of use and associated products. The previously proposed concentration limit was intended to result in reduced dermal and inhalation exposure. As a result, the ECEL included in the 2017 proposed rule was not an ECEL for all conditions of use of NMP, or even all paint and coating removal uses of NMP ( i.e., any products that would exceed the previously proposed concentration limit of 35%). This proposed rule for NMP as a whole chemical regulates 28 occupational conditions of use. For an ECEL to be useful, EPA would have to propose, for each of these conditions of use, requirements for dermal PPE, a specific concentration limit, and a corresponding ECEL. Even if it were feasible to identify such a large number of separate dermal PPE, concentration limits, and ECELs, EPA believes it would be potentially burdensome and confusing to the regulated entities if there were a multitude of requirements for specific dermal PPE, concentration limits, and inhalation ECELs for each condition of use that would continue under the WCPP. Regulated entities could potentially have to comply with several different ECELs and concentration limits for different conditions of use within one facility which may not be technically feasible. EPA notes that those potential concentration limits would most likely be lower than pure NMP, which many processing conditions of use require, or would be lower than efficacious for some commercial formulations. Additionally, even with an ECEL, regulated entities would still have to prevent direct dermal contact by workers to NMP. For these reasons, instead of proposing a multitude of ECELs, EPA is proposing a robust WCPP that—through the requirements to develop and implement exposure control plan, identify restricted areas, and take mitigation measures to prevent direct dermal contact—will address the unreasonable risk from NMP for the specified conditions of use, without adding extra challenges of ECEL monitoring and compliance.

EPA is also not proposing an existing chemical dermal exposure limit because biomonitoring methods, such as blood concentration testing or urine analysis to measure compliance to a dermal exposure limit, may not be readily available or feasible for most workplaces to implement. OSHA requires biomonitoring for only three chemicals (benzene, cadmium, and lead), and has not required any other chemical biomonitoring since 1981 (Refs. 49, 50, 51). NIOSH has no has no RELs based on biomonitoring, and EPA is not aware of any standard biomonitoring practice in the United States for solvents. EPA does not believe that biomonitoring methods are standard procedures in most occupational uses and requests public comment if these methods are viable to implement in the workplace.

To address the unreasonable risk, EPA also considered limiting the weight fraction of NMP in products and formulations without requirements for dermal or respiratory PPE. As described in Unit V.A.1.a., EPA determined that the unreasonable risk from NMP would not be contributed to by use of products containing NMP at less than 0.1% by weight. However, for all industrial/commercial and consumer conditions of use, the concentration limit of 0.1% is so low that it is highly unlikely that NMP would still serve its functional purpose in the product or formulation. EPA thus concluded that a weight fraction restriction without accompanying PPE requirements would essentially function as a prohibition for the conditions of use listed in Unit IV.A.2, and EPA therefore did not propose a weight fraction for those occupational conditions of use. EPA is however proposing a de minimis level for products containing NMP at levels of less than 0.1% to account for impurities that do not contribute to the unreasonable risk, as described in Unit IV.A.1.b.

After considering the different regulatory options under TSCA section 6(a), alternatives (described in Unit V.B.), compliance dates, and other requirements under TSCA section 6(c), EPA developed the proposed regulatory action described in Unit IV.A. to address the unreasonable risk from NMP so it is no longer unreasonable. To ensure successful implementation of this proposed regulatory action, EPA considered other requirements to support compliance with the proposed regulations, such as requiring monitoring and recordkeeping to demonstrate compliance with the NMP WCPP and downstream notification regarding the prohibition on manufacturing, processing, distribution in commerce, and use of NMP, including products containing NMP. These proposed requirements are described in Unit IV.A.

As required under TSCA section 6(d), any rule under TSCA section 6(a) must specify mandatory compliance dates, which shall be as soon as practicable with a reasonable transition period, but no later than 5 years after the date of promulgation of the final rule (for NMP, EPA notes an exception for the two uses Start Printed Page 51173 exempted under TSCA section 6(g)). These compliance dates are detailed in Unit IV.A. and IV.B. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must consider, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. To that end, in addition to an Economic Analysis (Ref. 5), EPA conducted an Alternatives Assessment, using reasonably available information (Ref. 4).

For this assessment, EPA identified and analyzed alternatives to NMP in products relevant to industrial, commercial, and consumer conditions of use proposed to be prohibited or restricted, even if such restrictions are not anticipated to substantially prevent the condition of use. Based on reasonably available information, including information submitted by industry, EPA understands viable alternatives to NMP may not be available for several conditions of use—for example, the industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and component manufacturing; for use in semiconductor manufacturing; or the industrial and commercial use in lithium ion battery manufacturing for certain applications (Refs. 42, 44)—and considered that information to the extent practicable in the development of the regulatory options as described in Unit III.B.3. For some conditions of use (such as the industrial and commercial use of NMP in anti-freeze and de-icing products or in lubricants and greases), EPA was unable to identify products currently available for sale that contain NMP. EPA is soliciting comments on whether there are products in use or available for sale relevant to these conditions of use that contain NMP at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of NMP. These conditions of use are detailed in the Alternatives Assessment (Ref. 4).

For conditions of use for which products currently containing NMP were identified, EPA identified several hundred commercially available alternative products that do not contain NMP, and listed in the Alternatives Assessment, to the extent practicable, their unique chemical components, or ingredients. For each of these chemical components or ingredients, EPA identified whether it functionally replaced NMP for the product use and screened product ingredients for human health and environmental hazard, as well as identified flammability and global warming potential where information was reasonably available (Ref. 4). EPA then assigned a rating to the human health and environmental hazards, using a methodology described in the Alternatives Assessment document. In general, EPA identified products containing ingredients with a lower hazard screening rating than NMP for certain endpoints, while some ingredients presented higher hazard screening ratings than NMP (Ref. 4). These alternative hazard screening ratings are described in detail in the Alternatives Analysis grouped under common product use categories (Ref. 4).

Discussion of alternatives to NMP occurred during the SBAR Panel process outreach meetings. EPA's consideration of alternatives was informed by the information provided by SERs, which included known problems and risks with some available alternatives. Specifically, SERs discussed and the challenges of transitioning to alternative chemicals, which may not be as efficacious as NMP, including the lifespan of use of their current equipment, capital costs for new equipment and formulation certification, time to research alternatives and reformulate products, and compliance with any existing alternative chemical regulations (Ref. 26). SERs also identified concerns over certain chemical alternatives such as in extraction uses that are more toxic or flammable than NMP, or in coating removal uses where certain chemical alternatives also present supply chain challenges and limited or reduced availability compared to NMP. EPA notes the concerns expressed by SERs regarding availability of feasible alternatives. These discussions with SERs informed the Panel recommendations.

EPA has considered input from SERs and other stakeholders regarding alternatives to NMP, as well as the information used for the Alternatives Assessment.

In deciding whether to propose prohibition or other significant restrictions on a condition of use of NMP and in proposing an appropriate transition period for any such action, EPA has therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use proposed to be prohibited or restricted, would be reasonably available as a substitute when a proposed prohibition or other significant restriction would become effective. EPA is additionally requesting comment on the Alternatives Assessment as a whole.

EPA's analysis of the health effects of NMP and the magnitude of human exposure to NMP are in the 2020 Risk Evaluation for NMP (Ref. 1). A summary is presented here.

The 2020 Risk Evaluation for NMP identified potential health effects of NMP including non-cancer adverse health effects such as reproductive toxicity, developmental toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and irritation and sensitization.

Among the non-cancer adverse health effects, for acute inhalation and dermal exposure scenarios, EPA identified non-cancer developmental effects ( i.e., increased fetal resorptions and mortality) as the most sensitive endpoint. For chronic inhalation and dermal exposure scenarios, EPA identified non-cancer reproductive effects (decreased fertility) as the most sensitive endpoints. NMP is not mutagenic and is not considered carcinogenic, so EPA did not conduct analysis of genotoxicity and cancer hazards in the risk evaluation.

Regarding the magnitude of human exposure, one factor EPA considers for the conditions of use that contribute to unreasonable risk is the size of the exposed population, which, for NMP, EPA estimates is 226,000 workers and 193,000 ONUs (Ref. 5). The number of consumers that use adhesive products containing NMP each year is unknown. EPA did not identify any consumer adhesive and sealant products containing NMP (Ref. 5).

For the conditions of use that contribute to the unreasonable risk for NMP, PESS include workers, ONUs, consumer users, bystanders, males and Start Printed Page 51174 females of reproductive age, pregnant women and the developing embryo/fetus, infants, children and adolescents, people with pre-existing conditions and people with lower metabolic capacity due to life stage, genetic variation, or impaired liver function.

In addition to workers, ONUs, consumers, and bystanders to consumer use directly exposed to NMP, EPA recognizes there is exposure to the general population from air and water pathways for NMP. During problem formulation, EPA conducted a first-tier screening analysis, for the ambient air pathway to near-field populations downwind from industrial and commercial facilities releasing NMP, that indicated low risk. In the 2020 Risk Evaluation, EPA conducted a first-tier analysis to estimate NMP surface water concentrations and did not identify risks from incidental ingestion or dermal contact during swimming. As mentioned in Unit II.D., EPA has separately conducted a screening approach to assess whether there may be potential risks to the general population from these exposure pathways that were unaccounted for in the NMP problem formulation and 2020 Risk Evaluation. The screening approach was developed to allow EPA to determine—with confidence—situations which present no unreasonable risk to fenceline communities or where further investigation would be needed to develop a more-refined estimate of risk. The fenceline technical support memos for the ambient air pathway and the water pathway provide the Agency with a quantitative assessment of exposure. EPA's fenceline analysis for the air pathway did not find risks to fenceline communities from ambient air (Ref. 15). EPA's fenceline analysis for the water pathway did not find risks from drinking water (Ref. 16). EPA therefore does not intend to revisit these air and water pathways for NMP as part of a supplemental risk evaluation.

EPA's analysis of the environmental effects of NMP and the magnitude of exposure of the environment to NMP are in the 2020 Risk Evaluation for NMP (Ref. 1). The unreasonable risk determination for NMP is based solely on risks to human health; based on the TSCA 2020 Risk Evaluation for NMP, EPA determined that exposures to the environment did not contribute to the unreasonable risk. A summary is presented here.

The manufacturing, processing, use, and disposal of NMP can result in releases to the environment, including aquatic releases of NMP from facilities that manufacture, use, or process NMP. Fate, exposure, and environmental hazard were evaluated in the 2020 Risk Evaluation for NMP to characterize environmental risk of NMP. NMP is not likely to accumulate in sediment due to its water solubility and low partitioning to organic matter. Upon releases of NMP to the atmosphere, it is degraded via reaction with photochemically produced hydroxyl radicals in ambient air. It may migrate through soil into groundwater, where NMP readily biodegrades in environments with active microbial populations. Additionally, NMP has low potential for bioaccumulation and bioconcentration in the environment.

Potential effects of NMP exposure described in the literature for aquatic life include mortality, immobilization, growth effects, and reproductive effects. EPA concluded that NMP poses a hazard to environmental aquatic organisms, including aquatic invertebrates, fish, and aquatic plants (algae). For acute exposures, NMP is a hazard to aquatic invertebrates based on immobilization and mortality, to fish based on mortality, and algae based on growth effects. For chronic exposures, NMP is a hazard to aquatic invertebrates based on reproductive effects, to fish based on an acute to chronic ratio approach extrapolating from the acute fish toxicity data, and to algae based on growth effects. EPA incorporated modeled exposure data from the Exposure and Fate Assessment Screening Tool or E-FAST as well as monitored data from the Water Quality Portal (Ref. 1), to characterize the exposure of NMP to aquatic species.

In the 2020 Risk Evaluation for NMP, the indicators evaluated for risk of injury to the environment include immobilization from acute exposure, growth effects from chronic exposure, and mortality to algae (Ref. 1). Based on the 2020 Risk Evaluation for NMP, EPA did not identify risk of injury to the environment that contributes to the unreasonable risk determination for NMP.

NMP is a water-miscible, organic compound used in a variety of industrial, commercial, pharmaceutical, and consumer use applications, including as a processing aid, as a solvent in petrochemical processing, in the production of electronics, cleaning and degreasing, and producing and removing paint, coatings, adhesives, and sealants, and other uses. The physical and chemical properties of NMP, such as low-flammability, low volatility, low vapor pressure, high boiling point, low viscosity and high affinity for aromatic hydrocarbons make it a popular and effective solvent and surface treatment for many applications (Ref. 1). Besides its use as a solvent, NMP is utilized in the recovery of hydrocarbons in the processing of petrochemicals. It is also used in the absorption of hydrogen sulfide in hydrodesulfurization facilities and the commercial preparation of polyphenylene sulfide, a high-performance engineering thermoplastic. In the pharmaceutical industry, NMP is used in the formulation of oral and transdermal drugs.

The main uses of NMP, by production volume, are in paint and coating removers, paints and coatings, electronics manufacturing, and plastic and resin manufacturing (Ref. 5). NMP effectively chemically removes various coatings from a substrate, such as furniture coatings or graffiti paint. There appears to be a trend towards alternatives to NMP in paint and coating removers as a result of the proposed rule published by EPA under TSCA section 6 in January 2017 regulating certain uses of methylene chloride and NMP ( 82 FR 7464 ). While that proposed rule was withdrawn in January of 2021, since January 2017, based on market research, the availability of consumer and commercial paint and coating removal products containing NMP has declined. However, there appears to be a market trend expanding electronic manufacturing in the United States, particularly as it related to lithium ion battery manufacturing and electronic vehicles and semiconductor chips. These production processes include uses of NMP with no known alternative and are expected to require the continued use of NMP over time.

In petrochemical manufacturing, NMP is used as a processing aid and extraction solvent. NMP is also used in a variety of cleaning products used in multiple industrial facilities and commercial shops, in soldering materials, and enhanced fertilizers.

EPA requests comments from the public about the importance of NMP in multiple existing product categories, including the potentially increased future importance of NMP to innovation and as an alternative. Start Printed Page 51175

The reasonably ascertainable economic consequences of this proposed rule include several components, all of which are described in the Economic Analysis for this proposed rule (Ref. 5). With respect to the anticipated effects of this proposed rule on the national economy, EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers and did not find that there would be an impact on the national economy (Ref. 5). The economic impact of a regulation on the national economy becomes measurable only if the economic impact of the regulation reaches 0.25% to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is equivalent to a cost of $40 billion to $80 billion. Therefore, because EPA has estimated that the cost of the proposed rule would range from $396 million annualized over 20 years at a 3% discount rate and $397 million annualized over 20 years at a 7% discount rate, EPA has concluded that this rulemaking is unlikely to have any measurable effect on the national economy (Ref. 5). Cost estimates by use category are provided in the Economic Analysis Table 7-36 (Ref. 5). In addition, EPA considered the employment impacts of this proposed rule, and found that the direction of change in employment is uncertain, but EPA expects the short-term and longer-term employment effects to be small.

Of the 61,851 small businesses potentially impacted by this proposed rule, 72% or 44,388 are expected to have impacts of less than 1% to their firm revenues, 11% or 6,965 are expected to have impacts between 1 and 3% to their firm revenues, and 17% or 10,497 are expected to have impacts greater than 3% to their firm revenues. Most businesses that would be affected by this regulation are in the following sectors: paints and coatings; paint, coating, adhesive removers; adhesive and sealants; inks, toners, and colorant products; and soldering. In addition to these sectors, some users of NMP (such as in plastic and resin product manufacturing or waste and disposal) may be significantly impacted because they have specific technical requirements which make the cost of modifications in response to WCPP requirements or the efficacy of potential alternatives hard to determine and appropriately capture in the analysis.

With respect to this proposed rule's effect on technological innovation, EPA expects this rulemaking to spur more innovation than it will hinder. A prohibition or significant restriction on the manufacture, processing, and distribution in commerce of NMP for uses covered in this proposed rule may increase demand for safer chemical substitutes. This proposed rule is not likely to have significant effects on the environment because NMP does not present an unreasonable risk to the environment, though this proposed rule does present the potential for small reductions in air emissions and soil contamination associated with improper disposal of products containing NMP. The effects of this proposed rule on public health are estimated to be positive, due to the reduced risk of non-cancer endpoints from exposure to NMP.

The costs and benefits that can be monetized for this proposed rule are described at length in in the Economic Analysis (Ref. 5). The monetized costs for this proposed rule are estimated to range from $396 million annualized over 20 years at a 3% discount rate and $397 million annualized over 20 years at a 7% discount rate. See the Economic Analysis Table 7-36 where total monetized costs are broken out per component of the proposed rule (Ref. 5). The health endpoints for NMP cannot be monetized at this time. However, as discussed in Unit IV.E., those endpoints can have significant, negative impacts on the lives of those exposed to NMP resulting in low birth weight, fetal loss, kidney toxicity, liver toxicity, and issues with fertility and fecundity (Ref. 5).

EPA considered the estimated costs to regulated entities as well as the cost to administer and enforce alternative regulatory actions. The alternative regulatory actions are described in detail in Unit IV.B. The estimated annualized costs of the alternative regulatory action are $165 million at a 3% discount rate and $185 million at a 7% discount rate over 20 years (Ref. 5). Again, the health endpoints for NMP cannot be monetized at this time. However, as discussed in Unit IV.E., those endpoints can have significant, negative impacts on the lives of those exposed to NMP resulting in low birth weight, fetal loss, kidney toxicity, liver toxicity, and issues with fertility and fecundity (Ref. 5).

This proposal is expected to achieve health benefits for the American public, that while tangible and significant, cannot be monetized. EPA believes that the balance of costs and benefits of this proposal cannot be fairly described without considering the non-monetized benefits of mitigating the non-cancer adverse effects. The multitude of adverse effects from NMP exposure can profoundly impact an individual's quality of life, as discussed in Units I.E. (estimated incremental impacts of the proposed rule), III.B.2. (description of the unreasonable risk), and VI.A. (discussion of the health effects), and also the 2020 Risk Evaluation for NMP. Chronic adverse effects of NMP exposure include the non-cancer effects listed in this unit. Acute effects of NMP exposure could be experienced for a shorter portion of life but are nevertheless significant in nature. The incremental improvements in health outcomes such as reproductive or developmental effects achieved by given reductions in exposure cannot be quantified for non-cancer health effects associated with NMP exposure, and therefore cannot be converted into monetized benefits. The qualitative discussion throughout this rulemaking and in the Economic Analysis highlights the importance of these non-cancer effects. Dismissing nonmonetized benefits of this rulemaking underestimates the impacts of NMP adverse outcomes and would imply there are no health benefits of this proposed rule from a reduction in NMP exposure.

Cost effectiveness is a method of comparing certain actions in terms of the expense per item of interest or goal. The goal of this proposed regulatory action is to prevent unreasonable risk resulting from exposure to NMP, and a major component of this regulatory action is eliminating or reducing NMP exposure to workers and ONUs. Per potentially exposed worker or ONU, the proposed regulatory action would cost $944 while the alternative regulatory action would cost $395 (using the 3% discount rate) to achieve the same goals. At a 7% discount rate, the proposed regulatory action would cost $948 while the alternative regulatory action would cost $442 per potentially exposed worker or ONU. While the proposed option has higher monetized costs, it may allow for more flexibility in some Start Printed Page 51176 sectors. In addition, the proposed option may result in potential lower exposures to workers and ONUs using NMP compared to the alternative option leading to reduced potential negative health outcomes for workers (Ref. 5).

TSCA section 9(a) provides that, if the Administrator determines, in the Administrator's discretion, that an unreasonable risk may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA, the Administrator must submit a report to the agency administering that other law that describes the risk and the activities that present such risk. TSCA section 9(a) describes additional procedures and requirements to be followed by EPA and the other Federal agency following submission of any such report. As discussed in this unit, for this proposed rule, the Administrator proposes to exercise his discretion not to determine that the unreasonable risk from NMP under the conditions of use may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA.

In addition, TSCA section 9(d) instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burdens of duplicative requirements. For this proposed rule, EPA has and continues to coordinate with appropriate Federal executive departments and agencies, including OSHA and the Consumer Product Safety Commission (CPSC), to, among other things, identify their respective authorities, jurisdictions, and existing laws with regard to NMP, which are summarized in this unit.

OSHA requires that employers provide safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance. As described in Unit II.C., OSHA has not established a PEL for NMP. Gaps exist between OSHA's authority to set workplace standards under the OSH Act and EPA's obligations under TSCA section 6 to eliminate unreasonable risk presented by chemical substances under the conditions of use. Health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only “to the extent feasible.” 29 U.S.C. 655(b)(5) . To set PELs for chemical exposure, OSHA must first establish that the new standards are economically and technologically feasible ( 79 FR 61384 , 61387 , Oct. 10, 2014). But under TSCA section 6(a), EPA's substantive burden is to demonstrate that, as regulated, the chemical substance no longer presents an unreasonable risk, with unreasonable risk being determined without consideration of costs or other non-risk factors. Thus, if OSHA were to initiate a new action, the difference in standards between the OSH Act and TSCA may well result in an OSHA action insufficient to address the unreasonable risk under TSCA.

In addition, OSHA may set exposure limits for workers, but its authority is limited to the workplace and does not extend to consumer uses of hazardous chemicals, and thus OSHA cannot address the unreasonable risk from NMP under all of its conditions of use, which include consumer uses. OSHA also does not have direct authority over state and local employees, and it has no authority over the working conditions of state and local employees in states that have no OSHA-approved State Plan under 29 U.S.C. 667 .

CPSC, under authority provided to it by Congress in the CPSA, protects the public from unreasonable risk of injury or death associated with the use of consumer products. Under the CSPA, CPSC has the authority to regulate NMP in consumer products, but not in other sectors such as automobiles, industrial and commercial products, or aircraft, for example. Further, a consumer product safety rule under the CPSA must include a finding that “the benefits expected from the rule bear a reasonable relationship to its costs,” 15 U.S.C. 2058(f)(3)(E) , whereas EPA must apply TSCA risk management requirements to the extent necessary so that the chemical no longer presents unreasonable risk and only consider costs and benefits of the regulatory action to the extent practicable, 15 U.S.C. 2605(a) , (c)(2). Additionally, the 2016 amendments to TSCA reflect Congressional intent to “delete the paralyzing `least burdensome' requirement,” 162 Cong. Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as originally enacted, which required EPA to use “the least burdensome requirements” that protect “adequately” against unreasonable risk, 15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under the CPSA must impose “the least burdensome requirement which prevents or adequately reduces the risk of injury for which the rule is being promulgated.” 15 U.S.C. 2058(f)(3)(F) . Analogous requirements, also at variance with recent revisions to TSCA, affect the availability of action CPSC may take under the Federal Hazardous Substances Act (FHSA) relative to action EPA may take under TSCA. 15 U.S.C. 1262 .

EPA therefore concludes that TSCA is the only regulatory authority able to prevent or reduce unreasonable risk of NMP to a sufficient extent across the range of conditions of use, exposures and populations of concern. This unreasonable risk can be addressed in a more coordinated, efficient and effective manner under TSCA than under different laws implemented by different agencies. Moreover, the timeframe and any exposure reduction as a result of updating OSHA or CPSC regulations cannot be estimated, while TSCA requires a much more accelerated 2-year statutory timeframe for proposing and finalizing regulatory requirements to address unreasonable risk. Further, there are key differences between the finding requirements of TSCA and those of the OSH Act, CPSA, and FHSA. For these reasons, in the Administrator's discretion, the Administrator has analyzed this issue and does not determine that unreasonable risk from NMP may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. However, EPA is requesting public comment on this issue ( i.e., the sufficiency of an action taken under a Federal law not administered by EPA).

If EPA determines that actions under other Federal laws administered in whole or in part by EPA could eliminate or sufficiently reduce a risk to health or the environment, TSCA section 9(b) instructs EPA to use these other authorities to protect against that risk unless the Administrator determines in the Administrator's discretion that it is in the public interest to protect against such risk under TSCA. In making such a public interest finding, TSCA section 9(b)(2) states: “the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk . . . and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.”

Although several EPA statutes have listed NMP as a volatile organic compound (Ref. 7), regulations under those EPA statutes have limitations because they largely regulate releases to the environment, rather than occupational or consumer exposures. While these limits on releases to the environment are protective in the Start Printed Page 51177 context of their respective statutory authorities, regulation under TSCA is also appropriate for occupational and consumer exposures and in some cases can provide upstream protections that would prevent the need for release restrictions required by other EPA statutes ( e.g., Resource Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)), including their associated permits.

The primary exposures and unreasonable risk to consumers and workers would be addressed by EPA's proposed prohibitions and restrictions under TSCA section 6(a). In contrast, the timeframe and any exposure reduction as a result of updating regulations for NMP under the CAA, CWA, or RCRA cannot be estimated, nor would they address the direct human exposure to consumers and workers from the conditions of use evaluated in the 2020 Risk Evaluation for NMP. More specifically, none of EPA's other statutes ( e.g., RCRA, CAA, CWA) can address exposures to workers related to the specific activities that result in occupational exposures, for example those associated with RCRA covered disposal requirements. EPA therefore concludes that TSCA is the most appropriate regulatory authority able to prevent or reduce risks of NMP to a sufficient extent across the range of conditions of use, exposures, and populations of concern.

For these reasons, the Administrator does not determine that unreasonable risk from NMP under the conditions of use evaluated in the 2020 TSCA Risk Evaluation for NMP could be eliminated or reduced to a sufficient extent by actions taken under other Federal laws administered in whole or in part by EPA.

EPA is also providing notice to manufacturers, processors, and other interested parties about potential impacts to CBI that may occur if this rulemaking is finalized as proposed. Under TSCA section 14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a ban or phase-out of a chemical substance, the protection from disclosure of any CBI regarding that chemical substance and submitted pursuant to TSCA will be “presumed to no longer apply,” subject to the limitations identified in TSCA section 14(b)(4)(B)(i) through (iii). If this rulemaking is finalized as proposed, then pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against protection from disclosure would apply only to information about the specific conditions of use that this proposed rule would prohibit. Manufacturers or processors seeking to protect such information would be able to submit a request for nondisclosure as provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure would need to be submitted within 30 days after receipt of notice from EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such notice via the Central Data Exchange or CDX.

In accordance with TSCA section 26(h), EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science. As in the case of the unreasonable risk determination, risk management decisions for this proposed rule, as discussed in Unit III.B.3. and Unit V., were based on a risk evaluation that was subject to public comment and independent, expert peer review, and was developed in a manner consistent with the best available science and based on the weight of the scientific evidence as required by TSCA sections 26(h) and (i) and 40 CFR 702.43 and 702.45 .

In particular, the WCPP, prescribed concentration limits, and de minimis concentration limit are derived from the analysis in the 2020 Risk Evaluation for NMP; they likewise represent decisions based on the best available science and the weight of the scientific evidence (Ref. 37). As discussed in Unit V.A.1., EPA used supplemental modeling from the 2020 Risk Evaluation for NMP to derive the proposed de minimis concentration limit, which represents a level below which EPA would not expect product use to contribute to unreasonable risk.

The extent to which the various information, procedures, measures, methods, protocols, methodologies or models, as applicable, used in EPA's decisions have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this rule. Additional information on the peer review and public comment process, such as the peer review plan, the peer review report, and the Agency's response to comments, can be found in EPA's risk evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0743).

EPA is requesting public comment on all aspects of this proposal, including the proposed and alternative regulatory actions and all individual elements of these, and all supporting analysis. Additionally, within this proposal, the Agency is soliciting feedback from the public on specific issues throughout this proposed rule. For ease of review, this unit summarizes those specific requests for comment, with numbering provided to help simplify referencing.

1. In Unit I.C., EPA seeks public comment on all aspects of this proposal.

2. In Unit I.E., EPA seeks public comment on methodologies for developing noncancer human dose-response curves and valuation methods for the health endpoints identified for NMP in the Risk Evaluation, specifically willingness to pay studies.

3. In Unit III.A., EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions and is providing notice that based on consideration of comments and any new information submitted to EPA during the comment period on this proposed rule, EPA may in the final rule modify elements of the proposed regulatory action.

4. In Unit III.B.1., EPA requests comment on whether EPA should promulgate definitions for those conditions of use evaluated in the 2020 Risk Evaluation for NMP that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for NMP and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation.

5. In Unit IV.A., EPA requests comment on allowing this de minimis level of NMP in products to account for impurities.

6. In Unit IV.A.1., EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes. Comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation.

7. In Unit IV.A.1., EPA requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply.

8. In Unit IV.A.1., EPA is requesting comment on: (1) Whether respiratory Start Printed Page 51178 protection and dermal PPE should be required before the effective date of the prohibition; (2) To what extent inhalation and dermal PPE may already be implemented in most uses being prohibited; and (3) Whether requirements that inhalation and dermal PPE be used before the effective dates of prohibitions would be overly burdensome to entities indicated in this unit that would be working to comply with the prohibition.

9. In Unit. IV.A.1., EPA is requesting comments from the public for more information about the uses EPA is proposing to prohibit, particularly the industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents, and the ability for workplaces in these conditions of use to comply with strict workplace controls like those required under the WCPP, or the ability to comply with a prohibition and reformulate to an alternative chemical or process.

10. In Unit IV.A.1., EPA requests comments on an appropriate, predictable process that could expedite reconsideration for uses that Federal agencies or their contractors become aware of after the final rule is issued using the tools available under TSCA, aligning with the requirements of TSCA section 6(g). EPA requests comment on whether the types of information described are the appropriate types of information for use in evaluating this type of category of use, and whether there are other considerations that should apply.

11. In Unit IV.A.1., EPA solicits comment on all aspects of its steps to accommodate in this proposed rule uses needed for national security or critical infrastructure and whether any additional measures are needed.

12. In Unit IV.A.2., EPA is requesting public comment on whether meeting this container size restriction to prevent commercial use would also have the same, though unintended, effect of reducing the consumer use.

13. In Unit IV.A.2., EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the container size restriction, and on what an appropriate container size restriction should be if not 16 ounces, and why.

14. In Unit IV.A.2., EPA is also seeking public comment on any alternative options to prevent diversion of consumer products to commercial uses. Comments should include documentation such as the specific container sizes of the NMP-containing products and estimates of the time and expenses required to implement the labeling requirement. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.

15. In Unit IV.A.3., EPA requests comment on available approaches, specifically monitoring methods ( e.g., charcoal patch testing) and frequency of sampling, to determine the effectiveness of engineering and administrative controls in preventing or reducing potential direct dermal contact to NMP.

16. In Unit IV.A.3., EPA also requests comment on whether requiring reporting on such monitoring could support enforcement and compliance assurance with this rulemaking.

17. In Unit IV.A.3., EPA requests comment on whether there should be general housekeeping or cleaning requirements in areas where the NMP is handled or where surfaces may be contaminated with NMP.

18. In Unit IV.A.3., EPA is also soliciting comment on requiring warning signs to demarcate restricted areas, similar to the requirements found in OSHA's General Industry Standard for Beryllium ( 29 CFR 1910.1024(m)(2) ).

19. In Unit IV.A.3., EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA's General Industry Standard for 1,3-Butadiene ( 29 CFR 1910.1051(h) ), or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA's General Industry Standard for Benzene ( 29 CFR 1910.1028(g)(3)(D) ).

20. In Unit IV.A.3., EPA is soliciting comments on the non-prescriptive proposed DDCC requirements for appropriate PPE selection, the effectiveness of PPE in preventing direct dermal contact with NMP in the workplace.

21. In Unit IV.A.3., EPA requests information on other potential dermal performance standards, and on general absorption and permeation effects to PPE as a result of direct contact.

22. In Unit IV.A.3., EPA understands that some workplaces rinse and reuse PPE after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing certain types of PPE, either gloves or protective clothing and gear.

23. In Unit IV.A.3., EPA also requests comment on the degree to which additional guidance related to use of PPE might be appropriate, including specifying PPE type or additional standard testing specifications.

24. In Unit IV.A.3., EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program.

25. In Unit IV.A.3., EPA requests comment relative to the ability of owners or operators in the private sector to implement such processes within 12 months of publication of the final rule in the Federal Register, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined in this unit. EPA also requests comment on whether the additional two years provided for agencies of the Federal Government and their contractors, when acting for or on behalf of the Federal government, to comply with the WCPP, should be provided more broadly to all entities complying with the WCPP.

26. In Unit IV.A.4., EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA's General Industry Standard for 1,3-Butadiene ( 29 CFR 1910.1051(h) ), or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA's General Industry Standard for Benzene ( 29 CFR 1910.1028(g)(3)(D) ).

27. In Unit IV.A.4., EPA is requesting public comment on whether additional documentation should be required to further support compliance and enforceability of the proposed regulatory requirements ( e.g., requirements for labels or SDS identifying percent of NMP within a product, or downstream notification of these proposed requirements for concentration limits and PPE, or other information that would be made available to industrial and commercial users to indicate compliance with the concentration limits).

28. In Unit IV.A.4., EPA requests comment on whether additional time is needed, other concentrations are required, or if there are available substitutes for this application.

29. In Unit IV.A.5., EPA is requesting public comment on whether additional documentation should be required to further support compliance and enforceability of the proposed regulatory requirements ( e.g., requirements for labels identifying the percent of NMP within a product or downstream notification of these proposed requirements for concentration limits).

30. In Unit IV.A.5., EPA requests comment on whether additional time is Start Printed Page 51179 needed, other concentrations are required, or if there are available substitutes for this application.

31. In Unit IV.A.6., EPA requests comments on all aspects of the proposed applicability of the WCPP to these narrowly described uses of higher concentration NMP in paint, coating, and adhesive removal and paints and coatings.

32. In Unit IV.A.6., EPA also requests comment on whether entities other than DOD, NASA or its contractors also require high concentration NMP and, if so, the extent to which lack of availability of high concentration NMP could impact their operations or pose potential challenges to the supply chain.

33. In Unit IV.A.6., EPA is requesting comment on whether EPA should also require reporting to EPA during purchasing of NMP for these specific uses by DOD, NASA, or their contractors and if requiring reporting could support of enforcement and compliance assurance with this rulemaking by further assuring that distribution of these high concentration NMP products for these uses is limited to DOD, NASA, and their contractors, and if such requirements would impose significant administrative burdens in addition compliance with the WCPP.

34. In Unit IV.A.7., EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this unit.

35. In Unit IV.B.1., EPA requests comment on this alternative regulatory action and whether any elements of this alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action.

36. In Unit IV.B.1., EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A.

37. In Unit IV.B.1., EPA requests comment on the ways in which NMP may be used in these conditions of use, including whether activities may take place in a closed system and the degree to which users of NMP in these sectors could successfully implement a WCPP (including DDCC) and ancillary requirements described in Unit IV.A.

38. In Unit IV.B.1., EPA is also requesting comment on whether any of the uses listed in this unit should be prohibited instead of requiring a WCPP, or if there are other factors like reduced concentration limits or limited access that could address the unreasonable risk.

39. In Unit IV.B.1., EPA requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A.

40. In Unit V.A.1., EPA requests comment on the workplace protection measures or exposure reduction measures typically applied during dip application of NMP, particularly dip degreasing and cleaning in hot or cold dip-tank immersion cleaning and degreasing, and dip application of NMP for adhesive, paint, or coating removal.

41. In Unit V.A.1., EPA also requests comment on the typical tasks expected during hot and cold dip cleaning or coating removal operations, including manual or automated opening and closing of the dip tank, cleaning and maintenance, the use of new or repurposed vapor degreasing machines for immersion cleaning, or any other dip-tank or immersion cleaning and degreasing activities.

42. In Unit V.A.1., EPA is interested in for comments on the ability of users of high concentrations of NMP in dip applications to successfully implement a WCPP, the availability of alternative chemicals, and impacts of prohibiting NMP for the hot or cold dip-tank cleaning, degreasing, or removal of adhesives, paints, or coatings.

43. In Unit V.A.1., EPA requests comment on the number of firms who utilize hot or cold dip NMP for cleaning, degreasing, or removal of adhesives, paints, and coatings and the frequency of dip applications and size of the dip vessel per firm is also of interest to EPA.

44. In Unit V.A.1., EPA also requests comment on the types of engineering controls and any PPE use by firms who use NMP in hot or cold dip applications.

45. In Unit V.A.1., EPA requests comment on how NMP is used in the agricultural sector, including whether there are any other application types (such as aerosol application) besides liquid product containing NMP blended with solid fertilizer pellets. EPA requests comment and supporting information on the degree to which entities using NMP in fertilizer manufacture or application may comply with the proposed WCPP requirements or similar stringent workplace controls for other conditions of use of NMP. EPA also requests comment on the workplace safety protocols in place during application, including expected exposure reductions during the use of NMP in fertilizer mixing and application, current engineering controls used, PPE usage and any standard hazard warnings or instructions in place. Specifically, EPA requests comments on whether there are alternatives to NMP for solvents used in the production of fertilizers, as well as alternatives to the use of NMP to reduce the volatility of advanced fertilizer products by keeping nitrogen from volatilizing into the atmosphere before it can be absorbed into the soil.

46. In Unit V.A.1., EPA requests comment regarding the number of businesses and other entities that could potentially close as well as associated costs with a prohibition of NMP for the industrial and commercial conditions of use identified in Unit IV.A.1.a.

47. In Unit V.A.1., EPA is requesting comment on the de minimis concentration limit of NMP in products or formulations. EPA emphasizes the agency's interest in aligning to the extent possible with the de minimis thresholds in the OSHA Hazard Communication Standard, while also noting that additional analytical work was conducted for NMP.

48. In Unit V.A.1., EPA requests comment on whether de minimis thresholds should be proposed consistent with national and international regulations, or whether there may be instances where chemical-specific analyses is appropriate.

49. In Unit V.A.1., EPA requests comment on if there are any NMP-containing consumer products that may require a more frequent or multiple day application, and if so, should EPA require additional restrictions for consumer products.

50. In Unit V.A.1., EPA requests comment on the potential impacts to consumers and the consumer use of these products from a container size requirement, as well as the appropriateness of the proposed respiratory protection requirements for these conditions of use as listed in Unit IV.A.4 and any impacts that the prescriptive use of respiratory protection may have on workplace operations.

51. In Unit V.A.1., EPA is also requesting comment on whether, rather than a container size restriction requirement, a maximum concentration limit for products containing NMP be required instead.

52. In Unit V.A.1., EPA requests comment on the typical or effective concentration of NMP in the following consumer products: paint and coating removers, adhesive removers, paints and coatings, paint additives and coating additives in arts and crafts paint, automotive care products, cleaning and furniture care products, and lubricant and lubricant additives, and whether a maximum concentration Start Printed Page 51180 of NMP could be identified that would allow the product to continue to be efficacious for consumer use, but that would not exceed the concentrations EPA has identified in Unit IV.A.1.e. for addressing the contribution of these types of products to unreasonable risk for workers.

53. In Unit V.A.1., EPA is seeking comment on whether the WCPP, with no concentration limits, should apply to all users of NMP in paints and coatings, and paint, coating and adhesive removal, rather than narrowly to DOD and NASA.

54. In Unit V.A.1., EPA is requesting comment on whether additional circumstances where specific PPE (including respirators) should be prescribed, as well as on the impacts on operations of requirements for the prescriptive use of respiratory protection for these conditions of use as listed in Unit IV.A.4.

55. In Unit V.A.1., EPA is requesting comment on whether preventing dermal contact with NMP through dermal PPE, training, and a concentration limit would adequately address the unreasonable risk from dermal exposures for these industrial and commercial use.

56. In Unit V.A.2., EPA is considering and requesting comment on an NMP WCPP—including requirements to prevent direct dermal contact—for some conditions of use of NMP that would be prohibited or otherwise regulated under the proposed regulatory action.

57. Unit V.A.2., EPA is requesting comment on the alternative regulatory action and in particular the likelihood of successful compliance with an NMP WCPP, as described in Unit IV.A., for the conditions of use listed for the alternative regulatory action of NMP WCPP in Unit IV.B.

58. In Unit V.A.2., EPA is soliciting comment on prohibiting for these occupational conditions of use.

59. In Unit V.A.3., EPA is requesting comment on whether to include a self-certification requirement for purchasing NMP or NMP-containing products.

60. In Unit V.A.3., EPA does not believe that biomonitoring methods are standard procedures in most occupational uses and requests public comment if these methods are viable to implement in the workplace.

61. In Unit V.B., EPA is soliciting comments on whether there are products in use or available for sale relevant to these conditions of use that contain NMP at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of NMP.

62. In Unit V.B., EPA is requesting comment on the Alternatives Assessment as a whole.

63. In Unit VI.C., EPA requests comments from the public about the importance of NMP in multiple existing product categories, including the potentially increased future importance of NMP to innovation and as an alternative.

64. In Unit VII.A., EPA is requesting public comment on the sufficiency of an action taken under a Federal law not administered by EPA.

65. In consideration of Panel report recommendations (Ref. 26) and in response to input provided by SERs, EPA is requesting comment on the following topics as outlined in the SBAR Panel Report:

• EPA requests comment on whether to allow the use of NMP by entities that could, based on demonstrated ability through recordkeeping and utilization of a combination of controls (including engineering controls, administrative controls, and PPE requirements), eliminate direct dermal contact with NMP to address the unreasonable risk.
• EPA requests comment in the NPRM on reasonable compliance timeframes for small businesses. Specifically, EPA requests comment on whether and how to provide longer compliance timeframes for transitioning to alternatives for uses requiring reformulation. As part of this effort, EPA seeks comment on and consider compliance timelines based on the expected availability of technically and economically feasible alternatives, as well as any information that could be provided based on requirements for certification or standards relevant to pesticides, or as a solvent in products such as industrial cleaners, paint strippers, and oil refining.
• EPA request comments on differing compliance or reporting requirements or timetables that account for the resources available to small entities. Additionally, EPA seeks comment on reasonable compliance timeframes for prohibitions or phase-outs on use of NMP in chemical processing and formulation, in response to SER input and other appropriate factors, such as the lifespan of equipment, capital costs for new equipment and certification, time to research alternatives, and time to reformulate products. In addition, EPA requests comment on any additional appropriate factors for identifying reasonable compliance timeframes and how to weigh the factors for chemical processing, agricultural product manufacturing, petrochemical refining, and other industries.
• EPA requests comment in the NPRM on a de minimis level in the case of an impurity or trace amounts of NMP in products.
• EPA requests comment on whether any chemicals identified by the Agency as part of the TSCA risk evaluation process as presenting an unreasonable risk of injury to health or the environment as well as chemicals undergoing risk evaluation would be likely to be considered as viable alternatives and, if so, in which circumstances.
• EPA requests comment on a regulatory approach for those conditions of use where EPA has confidence that exposures to NMP can be effectively controlled, would provide flexibility for regulated entities to incorporate the hierarchy of controls and reduce exposures so that the unreasonable risk is no longer present.
• EPA seeks comment on state of the art equipment, engineering and administrative controls, and monitoring for dermal exposures.
• EPA requests public comment on a limited access program for the sale of products containing NMP that could require training and certification or restrict distribution only to users with certain equipment that could reduce or eliminate dermal exposures or type of facilities.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. EPA. Risk Evaluation n-Methylpyrrolidone. December 2020.

2. EPA. Final Revised Unreasonable Risk Determination for n-Methylpyrrolidone, Section 5. December 2022.

3. EPA. n-Methylpyrrolidone (NMP); Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability. Federal Register. 87 FR 242 , December 19, 2022 (FRL-9943-02-OCSPP).

4. EPA. Alternatives Assessment for Use of n-Methylpyrrolidone. September 2023.

5. EPA. Economic Analysis of the Proposed Regulation of N-Methylpyrrolidone. May 2024.

6. EPA. Chemical Data Reporting. 2020. https://www.epa.gov/​chemical-data-reporting/​access-cdr-data .

7. EPA. Regulatory Actions Pertaining to N-Methylpyrrolidone. May 2024. Start Printed Page 51181

8. NIOSH. Hierarchy of Controls. Last Reviewed January 17, 2023. https://www.cdc.gov/​niosh/​topics/​hierarchy/​ .

9. Solomon et al. 1-methyl-2-pyrrolidone (NMP): Reproductive and developmental toxicity study by inhalation in the rat. http://dx.doi.org/​10.3109/​01480549509014324 .

10. The American Industrial Hygiene Association (AIHA). OARS WEEL Table. https://www.tera.org/​OARS/​#reservations .

11. Saillenfait et al. Developmental toxicity of N-methyl-2-pyrrolidone in rats following inhalation exposure. http://dx.doi.org/​10.1016/​S0278-6915(02)00300-9 .

12. Exxon Biomedical Sciences. Multigeneration Rat Reproduction Study with n-Methylpyrrolidone, Project Number 236535.

13. European Union. Regulations. April 18, 2018.

14. Lee et al. Toxicity of N-methyl-2-pyrrolidone (NMP): Teratogenic, subchronic, and two-year inhalation studies. http://dx.doi.org/​10.1016/​0272-0590(87)90045-5 .

15. EPA. Memorandum of n-Methylpyrrolidone (NMP): Fenceline Technical Support—Ambient Air Pathway.

16. EPA. Memorandum of n-Methylpyrrolidone (NMP): Fenceline Technical Support—Water Pathway. July 17, 2023.

17. EPA. TSCA Work Plan Chemical Risk Assessment N-Methylpyrrolidone: Paint Stripper Use. March 2015.

18. Executive Order 13985 . Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. Federal Register . 86 FR 7009 , January 20, 2021.

19. Executive Order 13990 . Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. Federal Register . 86 FR 7037 , January 25, 2021.

20. Executive Order 14008 . Tackling the Climate Crisis at Home and Abroad. Federal Register . 86 FR 7619 , February 1, 2021.

21. EPA. EPA Announces Path Forward for TSCA Chemical Risk Evaluations. June 30, 2021. https://www.epa.gov/​newsreleases/​epa-announces-path-forward-tsca-chemical-risk-evaluations .

22. EPA. Science Advisory Committee on Chemicals Meeting Minutes and Final Report No. 2022-01. March 15-17, 2022. https://www.regulations.gov/​document/​EPA-HQ-OPPT-2021-0415-0095 .

23. EPA. Notes from Federalism Consultation on Forthcoming Proposed Rulemakings for Trichloroethylene, Perchloroethylene, and n-Methylpyrrolidone under TSCA Section 6(a). July 22, 2021.

24. EPA. Notes from Tribal Consultations on Forthcoming Proposed Rulemakings for n-Methylpyrrolidone.

25. EPA. Notes from Environmental Justice Consultations on Forthcoming Proposed Rulemakings for n-Methylpyrrolidone (NMP). July 7 and July 13, 2021.

26. Small Business Advocacy Review. Final Report of the Small Business Advocacy Review Panel on EPA's Planned Proposed Rule for n-Methylpyrrolidone (NMP).

27. EPA. Initial Regulatory Flexibility Analysis (IRFA) for Proposed Regulation of n-Methylpyrrolidone. May 2024.

28. EPA. Public Webinar on n-Methylpyrrolidone (NMP): Risk Evaluation and Risk Management under TSCA Section 6. February 24, 2021.

29. EPA. Stakeholder Meeting List for Proposed Rulemaking for N-Methylpyrrolidone under TSCA Section 6(a).

30. EPA. 2021 Policy on Children's Health. October 5, 2021.

31. EPA. Instructions for Reporting 2020 TSCA Chemical Data Reporting. May 2020.

32. EPA. Revised Titles for the NMP Conditions of Use from the Final Risk Evaluation.

33. EPA. Problem Formulation of the Risk Evaluation for N-Methylpyrrolidone. May 2018.

34. EPA. Supplemental Information on Occupational Exposure Assessment. December 2020.

35. OSHA. Recommended Practices for Safety and Health Programs. October 2016. https://www.osha.gov/​safety-management .

36. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/​sites/​default/​files/​publications/​osha3151.pdf .

37. EPA. NMP Supplemental File with Additional Occupational PBPK Runs. December 2023.

38. EPA. Supplemental Data File of Results of Additional Consumer PBPK Runs.

39. DuPont. Meeting with DuPont on NMP Risk Evaluation/Risk Management. September 13, 2023.

40. European Commission. Regulation (EC) No 1907/2006. December 18, 2006.

41. EPA. Supplemental Data File of Results of NMP Air Concentration and Weight Fraction Modeling.

42. Semiconductor Industry Association (SIA). Comments of the Semiconductor Industry Association (SIA) on the Draft Toxic Substances Control Act (TSCA) Risk Evaluation for N-Methylpyrrolidone (NMP). January 21, 2020.

43. EPA. Meeting with Celanese on Risk Management under TSCA Section 6 for n-Methylpyrrolidone. March 9, 2021.

44. Lithium Ion Cell Manufacturers' Coalition (LICMC). Correspondence from the Lithium Ion Cell Manufacturers' Coalition on Risk Management for n-Methyl pyrrolidone (NMP). September 22, 2023.

45. NASA. NASA—Known Uses of n-Methylpyrrolidone. October 17, 2023.

46. EPA. Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a); Proposed Rule. Federal Register . 82 FR 12 , January 19, 2017 (FRL-9958-57).

47. EPA. Withdrawal of Proposed Rules; Discontinuing Three Rulemaking Efforts Listed in the Semiannual Regulatory Agenda. Federal Register . 86 FR 10 , January 15, 2021 (FRL-10018-67).

48. EPA. Recommendation for an Existing Chemical Exposure Concentration Limit (ECEL) for Occupational Use of N-Methylpyrrolidone (NMP) and Workplace Air Monitoring Methods for NMP [RIN 2070-AK07]. January 2017.

49. OSHA. 29 CFR 1910.1028 Benzene. September 27, 2023.

50. OSHA. 29 CFR 1910.1027 Cadmium. September 27, 2023.

51. OSHA. 29 CFR 1910.1025 Lead. September 27, 2023.

52. EPA. Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA); Regulation of n-Methylpyrrolidone under TSCA Section 6(a).

53. U.S. Consumer Product Safety Commission. What You Should Know About Using Paint Strippers.

54. OMB. Guidance for Implementing Title II of [UMRA]. March 31, 1995.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/​laws-regulations/​laws-and-executive-orders .

This action is a “significant regulatory action,” as defined under section 3(f)(1) of Executive Order 12866 ( 58 FR 51735 , October 4, 1993), as amended by Executive Order 14094 ( 88 FR 21879 , April 11, 2023). Accordingly, EPA submitted this action to OMB for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis (Ref. 5) is also available in the docket and is summarized in Unit VI.D.2.

The information collection activities in this proposed rule have been submitted to OMB for review and comment under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2786.01 (Ref. 52). You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.

There are two primary provisions of the proposed rule that may increase burden under the PRA. The first is downstream notification, which would be carried out by updates to the relevant SDS and which would be required for manufacturers, processors, and distributors in commerce of NMP, who would provide notice to companies Start Printed Page 51182 downstream upon shipment of NMP about the prohibitions. The information submitted to downstream companies through the SDS would provide knowledge and awareness of the restrictions to these companies. The second is WCPP-related information generation, recordkeeping, and notification requirements (including development of exposure control plans and related recordkeeping; development of documentation for a PPE program and related recordkeeping; development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, PPE program implementation documentation including glove testing; and development of self-certification documentation demonstrating eligibility for the WCPP if relevant, and related recordkeeping).

Respondents/affected entities: Persons that manufacture, process, use, distribute in commerce, or dispose of NMP or products containing NMP. See also Unit I.A.

Respondent's obligation to respond: Mandatory (TSCA section 6(a) and 40 CFR part 751 ).

Estimated number of respondents: 63,749.

Frequency of response: On occasion.

Total estimated burden: 189,534 hours (per year). Burden is defined at 5 CFR 1320.3(b) .

Total estimated cost: $219,812,949 (per year), includes $206,079,628 annualized capital or operation and maintenance costs, specifically glove testing.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. After display in the Federal Register when approved, the OMB control numbers for certain EPA regulations in title 40 of the CFR are listed in 40 CFR part 9 and displayed on the form and instructions or collection portal, as applicable.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at https://www.reginfo.gov/​public/​do/​PRAMain . Find this particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function. OMB must receive comments no later than July 15, 2024. EPA will respond to ICR-related comments in the final rule.

As required by section 609(b) of the RFA, the EPA convened a SBAR Panel to obtain advice and recommendations from SERs that potentially would be subject to the rule's requirements. The SBAR Panel evaluated the assembled materials and small-entity comments on issues related to elements of an IRFA. Prior to convening the Panel, EPA conducted outreach and solicited comments from the SERs. After the Panel was convened, the Panel provided additional information to the SERs and requested their input. SERs involved in the consultation included industries that manufacture fertilizer and other agricultural chemical manufacturing, chemical processors (including oil re-refiners), and formulators of paint and coating removal products. The Panel identified several significant uses of NMP and detailed workplace safety operations for consideration by the Administrator of the EPA that support the stated objectives of TSCA section 6 and minimize impacts of the proposed rule on small entities. The Panel recommended several exposure and reduction practices, including specific engineering and administrative controls and PPE, reviewed information about alternative chemicals, and discussed the regulation of NMP under FIFRA. EPA is including these considerations for the proposed rule and is soliciting comment on others. The report was finalized and transmitted to the EPA Administrator for consideration. A copy of the full SBAR Panel Report is available in the rulemaking docket, including SERs involved, materials presented to SERs, and recommendations. Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA prepared an initial regulatory flexibility analysis (IRFA) (Ref. 27) that examines the impact of the proposed rule on small entities along with regulatory alternatives that could minimize that impact. The complete IRFA is available for review in the docket and is summarized here.

Under TSCA section 6(a) ( 15 U.S.C. 2605(a) ), if EPA determines after a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a PESS identified as relevant to the risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. NMP was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020. In addition, in December 2022, EPA issued a revised unreasonable risk determination that NMP as a whole chemical substance presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that NMP no longer presents such risk.

Under TSCA section 6(a) ( 15 U.S.C. 2605(a) ), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. EPA has determined through a TSCA section 6(b) risk evaluation that NMP presents an unreasonable risk under the conditions of use.

The proposed rule potentially affects small manufacturers (including importers), processors, distributors, retailers, users of NMP or of products containing NMP, and entities engaging in disposal. EPA estimates that the proposal would affect approximately 61,851 small entities. Most (39,215) of these entities are commercial users of NMP in two sectors: fertilizer and other agricultural chemical manufacturing and paints and coatings. EPA also estimates the uses with the next largest numbers of small entities (20,962) using NMP include: paint, coating, and adhesive removers; electronic product and semiconductor manufacturing; waste handling, disposal, treatment, and recycling; adhesives and sealants; cleaning and furniture care products; and soldering.

To address the unreasonable risk EPA has identified, EPA is proposing to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP for several occupational conditions of use. To address the unreasonable risk to workers, EPA is also proposing to require container size limits and labeling requirements for the import, processing, and distribution in commerce of NMP products for several Start Printed Page 51183 consumer uses, to prevent diversion to commercial uses. For most other conditions of use that contribute to the unreasonable risk determination for NMP, EPA proposes to address the unreasonable risk with an NMP WCPP, which would include a combination of requirements including to prevent direct dermal contact with NMP. As described in Unit IV.A., the NMP WCPP would be non-prescriptive, in the sense that regulated entities would not be required to use specific controls prescribed by EPA to achieve the restrictions. The NMP WCPP would encompass restrictions on most occupational conditions of use and could include provisions for DDCC and ancillary requirements to support implementation of these restrictions. While the NMP WCPP includes stringent requirements that would be necessary to address the unreasonable risk from NMP, because the dermal exposures can be more effectively controlled in a broad range of facilities engaging in a relatively large number of conditions of use, EPA identified a relatively large number of conditions of use where the Agency expected, based on reasonably available information, an NMP WCPP could be successfully implemented. EPA is also proposing to require prescriptive controls, including concentration limits and PPE, for additional occupational conditions of use, instead of requirements for WCPP.

To address unreasonable risks to consumers, EPA proposes to require a concentration limit on NMP for the manufacture (including import), processing, and distribution in commerce of one consumer use.

Regarding recordkeeping requirements, three primary provisions of the proposed rule relate to recordkeeping. The first is recordkeeping of general records: all persons who manufacture, process, distribute in commerce, or engage in industrial or commercial use of NMP or NMP-containing products must maintain ordinary business records, such as invoices and bills-of-lading related to compliance with the prohibitions, restrictions, and other provisions of the regulation.

The second is recordkeeping related to WCPP compliance: under the proposed regulatory action, facilities complying with the rulemaking through WCPP would be required to develop and maintain records associated with DDCC compliance (including the exposure control plan, PPE program implementation, basis for specific PPE selection, occurrence and duration of direct dermal contact with NMP, and workplace information and training); and workplace participation. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP retain compliance records for five years.

Third, EPA is also proposing to require specific prescriptive controls for a few occupational conditions of use of NMP, to restrict the concentration limit and require PPE as detailed in Unit IV.A.3. for imported formulations, processing, distribution in commerce, and use of NMP in those conditions of use. EPA is also proposing to restrict the import, processing, distribution in commerce of NMP for one consumer use in concentrations greater than those specified in Unit III.A.3.c. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to the prescriptive controls requirements retain compliance records for five years.

Regarding third-party notification, EPA is not proposing reporting requirements beyond downstream notification, labeling, and self-certification for entities using NMP under the narrowly-applied WCPP for certain uses.

Downstream notification: To ensure compliance with downstream notification for WCPP EPA is proposing that manufacturers (including importers), processors, and distributors, excluding retailers, of NMP and NMP-containing products provide downstream notification of the prohibitions through the SDS required by OSHA under 29 CFR 1910.1200(g) by adding language as described in Unit IV.A.7.

Labeling: To ensure compliance with the container size restrictions for the products of the uses listed in Unit IV.A.2 EPA is proposing require products to be labeled with the prescribed text in Unit IV.A.2.

EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is especially important where, as here, such records are needed for effective implementation and enforcement of the TSCA section 6 rule to eliminate unreasonable risk. The self-certification would provide potentially exposed persons in a workplace with clear and necessary information and would provide EPA with a necessary evidence mechanism for effective enforcement. The regulated entities would develop, compile, and retain records that are necessary for self-certification compliance, provide workplace notification to potentially exposed persons, and serve as a reference for EPA or authorized entities. These records include a self-certification statement and all records as required by the NMP WCPP.

The small entities that would be potentially directly regulated by this rulemaking are small entities that manufacture (including import), process, distribute in commerce, use, or dispose of NMP, including retailers of NMP for end-consumer uses.

Entities that would be subject to this proposal that manufacture (including import), process, or distribute NMP in commerce would be required to modify their SDS or develop another way to inform their customers of the prohibitions and requirements for WCPP. Some entities would also be required to update product labels or containers. They would also be required to maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation. These are all routine business tasks that do not require specialized skills or training.

Entities that use NMP in any industrial and commercial capacity that is prohibited would be required to cease under the proposed rule. While this would not require any special skills, the implementation of an alternative chemical or the cessation of use of NMP in a process or equipment may require persons with specialized skills, such as engineers or other technical experts. Instead of developing an alternative method themselves, commercial users of NMP may choose to contract with another entity to do so.

Entities that would be permitted to continue to manufacture, process, distribute, use or dispose of NMP would be required to implement a WCPP and would have to meet the provisions of the program for continued use of NMP. Entities that would be permitted to continue use of NMP in the uses listed in Unit IV.A.4 would be required to implement prescriptive controls, including concentration limits and PPE program restrictions for continued use of NMP. A transition to a WCPP or prescriptive controls may require persons with specialized skills such as an engineer or health and safety professional. Instead of implementing the WCPP or prescriptive controls for Start Printed Page 51184 themselves, entities that use NMP may choose to contract with another entity to do so. Records would have to be maintained for compliance with a WCPP or prescriptive controls, as applicable. While this recording activity itself may not require a special skill, the information to be measured and recorded may require persons with specialized skills such as an industrial hygienist.

Because of its health effects, NMP is subject to some Federal laws and regulations in the United States and is also subject to regulation by some states and other countries. The following is a summary of the regulatory actions pertaining to NMP; for a full description , see appendix A of the 2020 Risk Evaluation for NMP and the summary in the docket (Ref. 7).

NMP is listed on the Toxics Release Inventory (TRI) pursuant to section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). NMP is regulated on the Federal Food, Drug, and Cosmetic Act (FFDCA) under FFDCA section 408 NMP is currently approved for use as a solvent and co-solvent inert ingredient in pesticide formulations for both food and non-food uses and is exempt from the requirements of a tolerance limit ( 40 CFR part 180.920 ). Under the Clean Air Act (CAA) section 183(e) and section 111(b) NMP is subject to several reporting standards and is listed on the Equipment Leaks Chemical List ( 40 CFR 68.130 ).

In addition to regulations administered by EPA, NMP is also subject to other Federal regulations. The Consumer Product Safety Commission (CPSC) issued a fact sheet in 2013, warning the public about hazards of paint and coating removal products, including those containing NMP. The fact sheet included recommendations for PPE when using products containing NMP (Ref. 53). The U.S. Food and Drug Administration (FDA) identifies NMP as an “Indirect Additive Used in Food Contact Substances” and as a Class 2 solvent, namely a solvent that “should be limited in pharmaceutical products because of their inherent toxicity.” FDA established a Permissible Daily Exposure (PDE) for NMP of 5.3 mg/day with a concentration limit of 530 ppm, and its Center for Veterinary Medicine developed a method in 2011 for detection of the residues of NMP in edible tissues of cattle ( 21 CFR 500.1410 ).

When meeting certain combustibility criteria ( i.e., boiling point less than 200 °F), NMP may be regulated as a hazardous material by the U.S. Department of Transportation (DOT) when transported by highway, rail, vessel, or air. As such, transporting NMP may be subject to certain requirements under Section 5103 of the Federal Hazardous Material Transportation Act ( 49 U.S.C. 5103 ) and the Hazardous Materials Regulations (HMR; 49 CFR parts 171 through 180 ), such as shipping papers, marking, labeling, placarding, etc.

State actions pertaining to NMP include listing NMP in state air regulations. New Hampshire lists NMP as a regulated toxic air pollutant (Env-A 1400: Regulated Toxic Air Pollutants) and Vermont lists NMP as a hazardous air contaminant (Vermont air Pollution Control Regulations, 5261). California has a PEL for NMP of 1 part per million (ppm) as an 8-hr-time-weighted average (TWA) along with a skin notation for NMP (California Code of Regulations, title 8, section 5155). California also lists NMP on Proposition 65 due to reproductive toxicity (Cal. Code Regs. Title 27, Section 27001). California's Office of Environmental Health Hazard Assessment (OEHHA) lists a Maximum Allowable Dose Level (MADL) for inhalation exposure = 3,200 micrograms per day (μg/day) and MADL for dermal exposure = 17,000 μg/day. The California Department of Toxic Substances Control (DTSC) Safer Consumer Products Program lists NMP as a Candidate Chemical for development toxicity and reproductive toxicity. Several other states have adopted reporting laws for chemicals in children's products that include NMP. Minnesota has listed NMP as a chemical of concern to children (Minnesota Statutes 116.9401 to 116.9407).

International actions pertaining to NMP include the listing, in 2011, of NMP on the Candidate list as a Substance of Very High Concern (SVHC) under regulation (EC) No 1907/2006 to the Regulation, Evaluation, Authorisation and Restriction of Chemicals (REACH). In 2018 the European Union added NMP to REACH Annex XVII, the restricted substances list. The restriction includes three conditions: that NMP shall not be placed on the market above 0.3% unless users have chemical safety reports and SDSs with set inhalation and dermal Derived No-Effect Levels (DNELs); NMP shall not be used above 0.3% unless appropriate risk management measures ensure that the exposure of workers is below the DNELs; and an exclusion from the regulation until May 9, 2024, for the use of NMP as a solvent or reactant in the process of coating wires. Several countries, including Australia, Belgium, Canada, Finland, Poland, and Spain have occupational exposure limits (OELs) for NMP (GESTIS International limit values for chemical agents OELs database, Accessed April 12, 2023).

EPA analyzed alternative regulatory approaches to identify which would be feasible, reduce burden to small businesses, and achieve the objective of the statute ( i.e., applying one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents an unreasonable risk). As described in more detail in Unit V., EPA considered several factors, in addition to identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: the effects of NMP on health and the environment, the magnitude of exposure to NMP of human beings and the environment, the benefits of NMP for various uses, and the reasonably ascertainable economic consequences of the rule. As part of this analysis, EPA considered—in addition to the proposed regulatory action described in Unit IV—a wide variety of control measures to address unreasonable risk from NMP such as point-of-sale self-certification, inhalation or dermal exposure limits, and weight fraction limits. EPA's analysis of these risk management approaches (as well as additional approaches) is detailed in Unit V.A.3. In general, EPA determined that these approaches alone would not be able to address the unreasonable risk. More detail is provided in this Unit and in Unit V.A.3.

Point-of-sale self-certification: As discussed in Unit V.A.3, EPA also examined the extent to which a point-of-sale self-certification requirement in order to purchase and subsequently use NMP would further ensure that only facilities able to implement and comply with a WCPP or prescriptive controls are able to purchase and use NMP, and self-certify to that. Under a self-certification requirement, entities would submit a self-certification to the distributor each time NMP is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP or required prescriptive controls to control exposures to NMP; the self-certification would be signed and presented by a person authorized to do so by the facility owner or operator. Copies of the self-certification would be maintained as records by both the owner or operator Start Printed Page 51185 and the distributor where NMP was purchased. While EPA is proposing to include a requirement for self-certification as part of the narrow application of the WCPP for two commercial uses of NMP in paints and coatings and paint, coating, and adhesive removers for DOD, NASA, and their contractors, that narrowly tailored self-certification differs from a broader point-of-sale self-certification requirement that would be applicable to all commercial users of products containing NMP. The self-certification proposed relies on the adherence of a narrowly-defined, highly regulated group of users (DOD, NASA, or their contractors) performing work at clearly defined facilities for specific purposes on mission- or safety-critical components in compliance with the WCPP requirements described in Unit IV.A.3.

In contrast, a broader self-certification requirement would place requirements on large and diverse groups of users and distributors. Because of the number and types of entities where users can obtain NMP or NMP-containing products, EPA does not believe the added requirement and subsequent burden of a point-of-sale self-certification requirement for the use of NMP would be an effective tool for preventing facilities that may be unable to comply with the WCPP or prescriptive controls of this proposed rulemaking from accessing NMP or NMP-containing products. As such, EPA is not proposing a self-certification requirement as an additional component of the requirements for addressing the unreasonable risk of occupational exposures to NMP.

Inhalation or dermal exposure limit: As discussed in Unit III.B.2, the 2020 Risk Evaluation for NMP assessed exposure from inhalation, dermal, and vapor through skin exposure, and identified that the unreasonable risk of injury to human health is mainly driven by direct dermal contact with NMP. EPA identified that the best representative endpoints for non-cancer effects were from acute (developmental toxicity) and chronic (reproductive toxicity) exposures for all conditions of use. Additional risks associated with other adverse effects ( e.g., liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation and sensitization) were identified. Therefore, EPA is proposing dermal exposure controls (or, as needed, prohibitions) to prevent direct dermal contact with NMP. While inhalation risks contribute to the unreasonable risk from NMP, addressing inhalation risks alone would not mitigate the unreasonable risk from NMP. As discussed in Unit V.A.3 of the proposed rule, EPA also examined the extent to which setting an Existing Chemical Exposure Limit (ECEL) or a dermal exposure limit as a regulatory action would address the unreasonable risk by inhalation and dermal exposures. EPA is not proposing an ECEL because the unreasonable risk to workers from NMP is driven by dermal exposures, and an ECEL would only address risk from inhalation and vapor-through-skin (dermal exposure to vapor but not direct dermal contact with a liquid) exposures. Therefore, requirements to meet an ECEL would not address the unreasonable risk from dermal exposure. EPA is also not proposing an existing chemical dermal exposure limit because biomonitoring methods, such as blood concentration testing or urine analysis to measure compliance to a dermal exposure limit, may not be readily available or feasible for most workplaces to implement. EPA does not believe that biomonitoring methods are standard procedures in most occupational uses. As such, EPA is not proposing an inhalation or dermal exposure requirement for addressing the unreasonable risk of occupational exposures to NMP.

Weight fraction limit: To address the unreasonable risk, EPA also considered limiting the weight fraction of NMP in products and formulations without requirements for dermal or respiratory PPE. As described in Unit V.A.1.a., EPA determined that the unreasonable risk from NMP would not be contributed to by use of products containing NMP at less than 0.1% by weight. However, for all industrial/commercial and consumer conditions of use, the concentration limit of 0.1% is so low that it is highly unlikely that NMP would still serve its functional purpose in the product or formulation. EPA thus concluded that a weight fraction restriction without accompanying PPE requirements would essentially function as a prohibition. for the conditions of use listed in Unit IV.A.2, and EPA therefore did not propose a weight fraction for those occupational conditions of use. EPA is however proposing a de minimis level for products containing NMP at levels of less than 0.1% to account for impurities that do not contribute to the unreasonable risk., as described in Unit IV.A.1.b.

Additionally, in the proposed rule preamble and the Economic Analysis, EPA has examined a primary alternative regulatory action. The primary alternative regulatory action described in this proposed rule and considered by EPA combines prohibitions and requirements for a WCPP. While in some ways it is similar to the proposed regulatory action, the primary alternative regulatory action described in this proposed rule differs from the proposed regulatory action by providing for a WCPP, including DDCC, for some conditions of use that would be prohibited or have prescriptive controls under the proposed regulatory action. Additionally, the primary alternative regulatory action includes prohibitions for one industrial and commercial use and the manufacturing, processing, and distribution in commerce for one consumer use; all of which would be required to have prescriptive controls under the proposed regulatory action. The primary alternative regulatory action would not include restrictions on the container size of consumer products that may feasibly be used for commercial purposes. In its review of alternatives, EPA determined that some methods either did not effectively address the unreasonable risk presented by NMP or there was uncertainty about whether facilities in conditions of use would be able to comply with a comprehensive WCPP to adequately protect potentially exposed persons. While EPA is soliciting comments about all aspects on each of the alternative regulatory actions, which may be incorporated into the final rulemaking, EPA has considered the primary alternative regulatory actions and found that the proposed action is more suitable for addressing the unreasonable risk to the extent necessary so that NMP no longer presents such risk, while also allowing flexibility for regulated entities to continue operations, as described in more detail in Unit IV.A. and V.A. Estimated costs of the primary alternative regulatory action can be found in chapter 7 of the Economic Analysis (Ref. 5).

This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-1538 , that may result in expenditures of $100 million or more for State, local and Tribal governments, in the aggregate, or the private sector in any one year. Accordingly, the EPA has prepared a written statement required under UMRA section 202 and section 205. The statement is included in the docket for this action and is briefly summarized here.

EPA estimated the compliance costs of the proposed rule to the private sector to be approximately $396 million annualized over 20 years at a 3% discount rate and $397 million annualized over 20 years at a 7% discount rate. However, the costs of the Start Printed Page 51186 rule to the private sector are difficult to completely quantify. It is difficult to predict firm behavior in response to regulation in the absence of firm specific revenue and cost and there are few sources that provide direct estimates for number of firms using NMP. As described in more detail in Units I.E. and VI.D.2. and Table 7-38 of the Economic Analysis (Ref. 5), EPA estimated costs assuming all firms using NMP comply with the proposed rule. Thus, the Agency concludes the cost of the rule to the private sector may exceed the inflation-adjusted UMRA threshold of $100 million in costs in any one year.

State, local, and Tribal governments are not expected to incur large costs because of the proposed rule since they are not known to engage in the manufacture, processing, distribution, or large-scale use of NMP. Costs to State, local and Tribal governments from this proposed rule would result from requirements related to disposal of NMP or products containing NMP, which are estimated to be less than $8 million annualized over 20 years at a 3% discount rate and 7% discount rate. In addition, if State, local and Tribal governments engage in various conditions of use of NMP for commercial use, they may need to switch to different products that no longer contain NMP or change the types of PPE workers wear when using NMP. EPA has identified many alternative products currently available at comparable prices. Since there is not a significant intergovernmental mandate, there is no need for Federal financial assistance ( e.g., grants or loans) or other Federal resources from either EPA or other Federal agencies to assist state, local, or Tribal governments in complying with the rule.

The rule's benefits include the prevention of the risk of numerous adverse health effects from NMP exposure. In addition to EPA's 2020 Risk Evaluation for NMP, many authorities have determined acute exposure to NMP may pose risks of developmental toxicity, notably irreversible fetal death. NMP chronic exposure is known to present risks of various non-cancer adverse health effects, including liver toxicity, kidney toxicity, reduced male fertility and reduced female fecundity impacts, and reproductive toxicity effects, notably low-birth weight.

The economic impact of a regulation on the national economy is generally considered to be measurable only if the economic impact of the regulation reaches 0.25 percent to 0.5 percent of GDP (Ref. 54). Given the current GDP of $23.17 trillion, this is equivalent to a cost of $58 billion to $116 billion. Therefore, EPA has concluded that this rulemaking is highly unlikely to have any measurable effect on the national economy. Additional information on EPA's estimates of the benefits and costs of this action are provided in Units I.E. and VI.D.2. and in the Economic Analysis for this action (Ref. 5). Information on the authorizing legislation is provided in Unit I.B. Information on prior consultations with affected State, local, and Tribal governments is provided in Unit III.A.1.

This action is not subject to the requirements of UMRA section 203 because it contains no regulatory requirements that might significantly or uniquely affect small governments.

EPA has concluded that this action has federalism implications as specified in Executive Order 13132 ( 64 FR 43255 , August 10, 1999), because regulation of NMP under TSCA section 6(a) may preempt state law. As set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA section 6(a) to address the unreasonable risk presented by a chemical substance has the potential to trigger preemption of laws, criminal penalties, or administrative actions by a state or political subdivision of a state that are: (1) Applicable to the same chemical substance as the rule under TSCA section 6(a); and (2) Designed to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of that same chemical. TSCA section 18(c)(3) applies that preemption only to the “hazards, exposures, risks, and uses or conditions of use” of such chemical included in the final TSCA section 6(a) rule.

EPA provides the following preliminary federalism summary impact statement. The Agency consulted with state and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. This included background presentation on September 9, 2020, and a consultation meeting on July 22, 2021. EPA invited the following national organizations representing state and local elected officials to these meetings: American Water Works Association, Association of Clean Water Administrators, Association of Metropolitan Water Agencies, Association of State Drinking Water Administrators, Environmental Council of the States, National Association of Counties, National Conference of State Legislatures, National Governors Association, National League of Cities, National Water Resources Association, and United States Conference of Mayors. During the consultation, stakeholders in attendance recommended additional reporting requirements as a risk management tool to address the unreasonable risk, suggested EPA look into safer alternatives, and described concerns related to current impacts on drinking water utilities from NMP (Ref. 23). A summary of the meeting with these organizations, including the views that they expressed, is available in the docket (Ref. 23). EPA provided an opportunity for these organizations to provide follow-up comments in writing but did not receive any such comments.

This action does not have Tribal implications as specified in Executive Order 13175 ( 65 FR 67249 , November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. This rulemaking would not have substantial direct effects on Tribal governments because NMP is not manufactured, processed, or distributed in commerce by tribes. NMP is not regulated by tribes, and this rulemaking would not impose substantial direct compliance costs on Tribal governments. Thus, Executive Order 13175 does not apply to this action.

Notwithstanding the lack of Tribal implications as specified by Executive Order 13175 , EPA met with Tribal representatives on this action, consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, which EPA applies more broadly than Executive Order 13175 . EPA scheduled consultations with representatives of Tribes via webinar on June 14, 2021, and July 14, 2021, concerning the prospective regulation of NMP under TSCA section 6(a). No attendance on June 14, 2020, resulted in the first scheduled consultation to be canceled. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for NMP, types of information to inform risk management, principles for transparency during risk management, and types of information EPA is seeking from Tribes (Ref. 24). EPA briefed Tribal officials on the Start Printed Page 51187 Agency's risk management considerations and tribal officials raised no related issues or concerns to EPA during or in follow-up to those meetings (Ref. 24). Tribal members were encouraged to provide additional comments after the teleconferences.

This action is subject to Executive Order 13045 ( 62 FR 19885 , April 23, 1997) because it is a significant regulatory action under section 3(f)(1) of Executive Order 12866 , and EPA believes that the environmental health or safety risk addressed by this action has a disproportionate effect on children due to reproductive and developmental health effects associated with NMP exposure. Accordingly, we have evaluated the environmental health effects of NMP exposure and associated health impacts on children and adults of reproductive age.

For infants and males and females of reproductive age, EPA found evidence of reproductive and developmental toxicity. The reproductive and developmental health effects of concern related to exposures to NMP are reduced male fertility and female fecundity and post-implantation loss (resorptions and fetal mortality). The results of this evaluation are in the 2020 Risk Evaluation for NMP (available in the public docket for this action) and in Unit III.A.3 and Unit VI.A.

This proposed action is preferred over other regulatory options analyzed because it will reduce to the greatest extent the exposure to NMP for the general population and for potentially exposed or susceptible subpopulations such as children and adults of reproductive age through a combination of prohibition, and prescriptive and non-prescriptive controls, including PPE use.

Furthermore, EPA's 2021 Policy on Children's Health also applies to this action. Information on how the Policy was applied is discussed in Unit III.A.3.

This action is not a “significant energy action” under Executive Order 13211 ( 66 FR 28355 , May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Pursuant to the NTTAA section 12(d), 15 U.S.C. 272 ., the Agency has determined that this rulemaking involves environmental monitoring or measurement, specifically for establishing that selected PPE would be impervious for the expected duration and conditions of exposure to NMP. Consistent with the Agency's Performance Based Measurement System (PBMS), the Agency proposes not to require the use of specific, prescribed analytic methods. Rather, the Agency plans to allow the use of any method that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified.

For this rulemaking, the key consideration for the PBMS approach is the ability to accurately report cumulative permeation rate as a function of time. Some examples of methods which meet the criteria are included in appendix F of the 2020 Risk Evaluation (Ref. 1) and described in Unit VI.A.3. EPA recognizes that there may be voluntary consensus standards that meet the proposed criteria. EPA requests comments on whether it should incorporate such voluntary consensus standards in the rule and seeks information in support of such comments regarding the availability and applicability of voluntary consensus standards that may achieve the sampling and analytical requirements of the rule in lieu of the PBMS approach.

EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns in accordance with Executive Orders 12898 ( 59 FR 7629 , February 16, 1994) and 14096 ( 88 FR 25251 , April 26, 2023). As described more fully in the Economic Analysis, EPA conducted an EJ analysis to characterize the baseline conditions faced by communities and workers affected by the regulation to identify the potential for disproportionate impacts on various communities. Informed by the fenceline analysis referenced in Unit VI.A., exposure to NMP is primarily experienced by consumers using NMP-containing products and workers and occupational non-users directly on site. The baseline characterization suggests residents of nearby communities within one mile and three miles are more likely to be People of Color and low-income relative to the general population in affected locations. Workers in the industries assessed, including industrial and miscellaneous chemical and paint, coating and adhesives, are less likely to be People of Color and low-income when analyzed using national industry data; however, local variation is obscured and the use of county-industry data suggests workers in affected counties with basic chemical manufacturing NMP facilities have larger representation of non-White, including Hispanic, workers and female workers ages 25-44. There is possible aggregate exposure concern for nearby communities given clustering of NMP facilities relative to other NMP facilities and possible cumulative exposure concern with nearby clustered TRI facilities that may also release or use other chemicals. Other indicators of cumulative concern include elevated cancer risk and PM 2.5 values for nearby communities one mile and three miles away from NMP facilities. Communities also exhibited slightly elevated perinatal mortality and very low birthweight rates, health end points of concern from NMP exposure. Note, these are indicators and not precise measures of actual risk and data limitations restrict the ability to causally link these health end points to specific facilities or workers (Ref. 1).

EPA believes that this action is likely to reduce existing disproportionate and adverse effects on communities with EJ concerns. While the regulatory options are anticipated to address the unreasonable risk from exposure to NMP to the extent necessary so that it is no longer unreasonable, EPA is not able to quantify the distribution of the change in risk across affected workers, communities, or demographic groups. EPA is also unable to quantify the changes in risks to workers, communities, and demographic groups from non-NMP-using technologies or practices that firms may adopt in response to the regulation to determine whether any such changes could pose EJ Start Printed Page 51188 concerns. Data limitations that prevent EPA from conducting a more comprehensive analysis are summarized in the Economic Analysis (Ref. 5).

EPA additionally identified and addressed EJ concerns by conducting outreach to advocates in affected communities that might be subject to disproportionate exposure to NMP. On July 7, 2021, and July 13, 2021, EPA held public meetings as part of this consultation (Ref. 25). See also Unit III.A.1. These meetings were held pursuant to Executive Order 12898 and Executive Order 14008 , entitled “Tackling the Climate Crisis at Home and Abroad” ( 86 FR 7619 , February 1, 2021).

Following the EJ meetings, EPA received one written comment, in addition to oral comments provided during the consultations. In general, commenters supported strong outreach to affected communities, encouraged EPA to follow the hierarchy of controls, favored prohibitions, and noted the uncertainty, and in some cases inadequacy, of PPE. Other commenters asked about the Agency's schedule for a proposed rule while reconsidering certain aspects of the 2020 Risk Evaluation. Additionally, commenters expressed concern that the adverse health impacts of NMP, particularly to pregnant people and children and urged EPA to ban the use of NMP in paint and coating removers, for the reasons discussed in this unit EPA is not proposing this ban (Ref. 25).

The information supporting this Executive Order review is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic Analysis (Ref. 5). EPA's presentations and fact sheets for the EJ consultations related to this rulemaking, are available at https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​materials-june-and-july-2021-environmental-justice . These materials and a summary of the consultation are also available in the public docket for this rulemaking (Ref. 25).

• Environmental protection
• Export Notification
• Hazardous substances
• Import certification
• Reporting and recordkeeping

Michael S. Regan,

Administrator.

Therefore, for the reasons stated in the preamble, EPA proposes to amend 40 CFR part 751 as follows:

1. The authority citation for part 751 continues to read as follows:

Authority: 15 U.S.C. 2605 , 15 U.S.C. 2625(l)(4) .

2. Amend § 751.5 by adding in alphabetical order definitions for “Direct dermal contact”, “Exposure group”, and “Restricted area” to read as follows:

Direct dermal contact means direct handling of a chemical substance or mixture or skin contact with surfaces that may be contaminated with a chemical substance or mixture.

Exposure group means a group consisting of every person performing the same or substantially similar operations in each work shift, in each job classification, in each work area where exposure to chemical substances or mixtures is reasonably likely to occur.

Restricted area means an area established by the regulated entity to demarcate areas where direct dermal contact with a specific chemical substance may occur.

3. Add subpart C to read as follows:

(a) Applicability. This subpart establishes prohibitions and restrictions on the manufacture (including import), processing, distribution in commerce, use, and disposal of n-methylpyrrolidone (CASRN 872-50-4) (NMP), to prevent unreasonable risks of injury to health in accordance with TSCA section 6(a).

(b) De minimis level. Unless otherwise specified in this subpart prohibitions and restrictions of this subpart do not apply to products containing NMP at levels less than 0.1 percent by weight.

The definitions in subpart A of this part apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:

Distribute in commerce has the same meaning as in section 3 of the Act, except that the term does not include retailers for purposes of § 751.213.

(a) Applicability. The provisions of this section apply to the following, as indicated in each paragraph of this section:

(1) Processing incorporation into articles in lubricants and lubricant additives in machinery manufacturing.

(2) Industrial and commercial conditions of use:

(i) Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greases;

(ii) Industrial and commercial use in metal products not covered elsewhere and lubricant and lubricant additives including hydrophilic coatings;

(iii) Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removers; and

(iv) Industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents.

(b) Prohibitions. (1) After [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from manufacturing (including importing) NMP for the uses listed in paragraphs (a)(1) and (2) of this section.

(2) After [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from processing NMP, including any NMP-containing products, for the conditions of use listed in paragraphs (a)(1) and (2) of this section.

(3) After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from distributing in commerce (including making available) NMP, including any NMP-containing products, to retailers for the conditions Start Printed Page 51189 of use listed in paragraph (a)(2) of this section.

(4) After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons and retailers are prohibited from distributing in commerce (including making available) NMP, including any NMP containing products, for the conditions of use listed in paragraph (a)(2) of this section.

(5) After [DATE 24 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from industrial and commercial use of NMP, including any NMP-containing products, for the conditions of use listed in paragraphs (a)(2) of this section.

(a) Applicability. The provisions of this section apply to the following, as indicated in each paragraph of this section.

(1) Processing incorporation into articles in paint additives and coating additives in transportation equipment manufacturing.

(i) Industrial and commercial use in paints, coatings, and adhesive removers, except for paint, coating, and adhesive removers for mission- or safety-critical components of aircraft, spacecraft, and vessels that are owned or operated by the U.S. Department of Defense and the National Aeronautics and Space Administration used in accordance with the requirements listed in § 751.217;

(ii) Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation, except for paints and coatings for mission- or safety-critical components of aircraft, spacecraft, and vessels that are owned or operated by the U.S. Department of Defense and the National Aeronautics and Space Administration used in accordance with the requirements listed in § 751.217;

(iii) Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale and retail trade;

(iv) Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including lubricant adhesives and two component glues and adhesives including some resins, excluding industrial and commercial use in specific adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants for aviation parts;

(v) Industrial and commercial use in ink, toner, and colorant products in printer ink; and

(vi) Industrial and commercial use in soldering materials;

(3) Consumer conditions of use:

(i) Consumer use in paint and coating removers;

(ii) Consumer use in adhesive removers;

(iii) Consumer use in paints and coatings in lacquer, stains, varnishes, primers and floor finishes;

(iv) Consumer use in paint additives and coating additives in paints and arts and crafts paints;

(v) Consumer use in automotive care products;

(vi) Consumer use in cleaning and furniture care products, including wood cleaners, gasket removers;

(vii) Consumer use in lubricant and lubricant additives, including hydrophilic coatings; and

(viii) Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives.

(b) Concentration limits. (1) Beginning [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] all persons are prohibited from importing NMP formulations and products containing:

(i) More than 45 percent by weight of NMP for the conditions of use listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii) of this section with more than 45 percent by weight of NMP.

(ii) More than 30 percent by weight of NMP for the conditions of use listed in paragraph (a)(2)(i) of this section.

(iii) More than 5 percent by weight of NMP for the condition of use listed in paragraph (a)(2)(v) of this section.

(iv) More than 1 percent by weight of NMP for the condition of use listed in paragraph (vi) of this section.

(2) Beginning [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] all persons are prohibited from processing NMP into formulations and products containing:

(i) More than 45 percent by weight of NMP for the conditions of use listed in paragraphs (a)(1), (a)(2)(ii) though (iv) and (a)(3)(viii) of this section with more than 45 percent by weight of NMP.

(iv) More than 1 percent by weight of NMP for the condition of use listed in paragraph (a)(2)(vi) of this section.

(3) After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from distributing in commerce (including making available) NMP and NMP-containing products to retailers for:

(i) More than 45 percent by weight of NMP the conditions of use listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii) of this section.

(4) After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from distributing in commerce (including making available) NMP and NMP-containing products containing:

(i) More than 45 percent by weight of NMP for the conditions of use listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii) of this section.

(ii) More than 30 percent by weight of NMP for the condition of use listed in paragraph (a)(2)(i) of this section.

(iv) More than 1 percent by weight of NMP and for the condition of use listed in paragraph (a)(2)(vi) of this section.

(5) After [DATE 24 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons are prohibited from commercial use of NMP and NMP-containing products containing:

(i) More than 45 percent by weight of NMP for the conditions of use listed in paragraphs (a)(1) and (a)(2)(ii) through (iv) of this section.

(c) Container size restrictions and labels. (1) After [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION Start Printed Page 51190 OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons, including retailers, are prohibited from processing and distributing in commerce (including making available) NMP or NMP-containing products in containers with a volume more than 16 ounces for the conditions of use listed in paragraphs (a)(3)(i) through (vii) of this section.

(2) After [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all processors and distributors in commerce of NMP or NMP-containing products for the conditions of use listed in paragraphs (a)(3)(i) through (vii) of this section must provide a label securely attached to each product. Label information must be prominently displayed and in an easily readable font size, with the sentence “This product is only for sale in containers of 16 ounces or less and is for consumer use only” in bold print or a larger font for emphasis. Each label must contain the following text:

(a) Applicability. The provisions of this section apply to workplaces engaged in the following conditions of use of NMP, unless otherwise indicated:

(1) Manufacturing (domestic manufacture).

(2) Manufacturing (import).

(3) All processing, except for the following:

(i) The processing described in § 751.205(a);

(ii) The processing described in § 751.207(a); and

(iii) The processing described in § 751.211(a).

(4) All industrial and commercial use, except for the following:

(i) Those industrial and commercial uses presented in § 751.205(a);

(ii) Those industrial and commercial uses presented in § 751.207(a); and

(iii) Those industrial and commercial uses presented in § 751.211(a).

(5) Disposal.

(b) Direct Dermal Contact Controls (DDCC). The provisions of this paragraph (b) apply to any workplace engaged in the conditions of use listed in paragraph (a) of this section.

(1) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for Federal agencies and Federal contractors acting for or on behalf of the Federal Government, [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for other owners and operators, or within 30 days of introduction of NMP into the workplace, owners or operators must ensure that all persons are separated, distanced, physically removed, or isolated from direct dermal contact with NMP in accordance with the requirements of paragraph (c)(1)(i) of this section and, if necessary, paragraph (e) of this section.

(2) Owners or operators must comply with all applicable provisions of paragraphs (c) through (f) of this section.

(c) Exposure control procedures and plan —(1) Methods of compliance. (i) The owner or operator must institute one or a combination of elimination, substitution, engineering controls, or administrative controls to prevent all persons from direct dermal contact with NMP except to the extent that the owner or operator can demonstrate that such controls are not feasible.

(ii) Wherever the feasible exposure controls, including one or a combination of elimination, substitution, engineering controls or administrative controls, required under paragraph (c)(1)(i) of this section, which can be instituted are not sufficient to prevent direct dermal contact, the owner or operator must use them to reduce direct dermal contact to the extent achievable and must supplement those controls with the use of dermal PPE that complies with the requirements of paragraph (e) of this section. Where an owner or operator cannot demonstrate direct dermal contact is prevented, including through the use of engineering controls or work practices, and has not demonstrated that it has supplemented feasible exposure controls with sufficient dermal PPE that complies with the requirements of paragraph (e) of this section, this will constitute a failure to comply with the direct dermal contact control requirements.

(iii) The owner or operator must maintain the effectiveness of engineering controls and administrative controls instituted under paragraph (c)(1)(i) of this section.

(iv) The owner or operator must document their exposure control strategy and implementation in an exposure control plan in accordance with paragraph (c)(2) of this section.

(2) Exposure control plan requirements. Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for Federal agencies and Federal contractors acting for or on behalf of the Federal Government, or [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for other owners and operators, owners and operators must include and document in an exposure control plan the following:

(i) Identification and rationale of exposure controls used or not used in the following sequence: elimination of NMP, substitution of NMP, engineering controls and administrative controls to prevent or reduce direct dermal contact with NMP in the workplace;

(ii) The exposure controls selected based on feasibility, effectiveness, and other relevant considerations;

(iii) If exposure controls were not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented;

(iv) Actions taken to implement exposure controls selected, including proper installation, maintenance, training, or other steps taken;

(v) Description of any restricted areas and how it is demarcated, and identification of authorized persons; and description of when the owner or operator expects exposures may be likely to result in direct dermal contact;

(vi) Regular inspections, evaluations, and updating of the exposure controls to ensure effectiveness and confirmation that all persons are implementing them as required;

(vii) Occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes any direct dermal contact with NMP and subsequent corrective actions taken during start-up, shutdown, or malfunctions to mitigate exposures to NMP; and

(viii) Availability of the exposure control plan and associated records for potentially exposed persons.

(d) Restricted areas. (1) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for Federal agencies and Federal contractors acting for or on behalf of the Federal Government, or [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] for other owners and operators, the owner or Start Printed Page 51191 operator who has implemented all feasible engineering, work practice and administrative controls as required in paragraph (b) of this section wherever direct dermal contact with NMP may occur must establish a restricted area.

(2) The owner or operator must limit access to restricted areas to authorized persons.

(3) The owner or operator must demarcate restricted areas from the rest of the workplace in a manner that adequately establishes and alerts persons to the boundaries of the restricted area and minimizes the number of authorized persons exposed to NMP within the restricted area.

(4) Whenever any direct dermal contact with NMP may occur within the restricted area the owner or operator must supply and ensure all persons are using dermal PPE that complies with the requirements of paragraph (e) of this section.

(5) The owner or operator must ensure that, within a restricted area, persons do not engage in non-work activities that may increase direct dermal contact exposure to NMP.

(e) Personal Protective Equipment (PPE). (1) The provisions of this paragraph (e) apply to any owner or operator that is required to provide dermal protection pursuant to paragraph (c) of this section or respiratory protection pursuant to § 751.211(b)(2).

(2) PPE, including respiratory and dermal protection, that is of safe design and construction for the work to be performed must be provided, used, and maintained in a sanitary, reliable, and undamaged condition. Owners and operators must select PPE that properly fits each affected person and communicate PPE selections to each affected person.

(3) Owners and operators must provide PPE training in accordance with 29 CFR 1910.132(f) to all persons required to use PPE prior to or at the time of initial assignment to a job involving potential exposure to NMP. For the purposes of this paragraph (e)(3) of this section, provisions in 29 CFR 1910.132(f) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.

(4) Owners and operators must retrain each potentially exposed person required to use PPE annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete.

(5) Dermal protection:

(i) The owner or operator must supply and require the donning of dermal PPE that provides an impermeable barrier to prevent direct dermal contact with NMP in the specific work area where it is selected for use, selected in accordance with this paragraph, to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with NMP.

(ii) Owners or operators must select and provide dermal PPE as specified in this paragraph (e)(5), and in accordance with 29 CFR 1910.133(b) , to each person who is reasonably likely to be dermally exposed in the work area through direct dermal contact with NMP. For the purposes of this paragraph (e)(5)(ii), the provisions in 29 CFR 1910.133(b) applying to an “employer” also apply equally to owners or operators.

(iii) Owners or operators must select and provide to persons appropriate dermal PPE based on an evaluation of the performance characteristics of the PPE relative to the task(s) to be performed, conditions present, and the duration of use. Such appropriate dermal PPE must at minimum include, but is not limited to, the following items:

(A) Impervious gloves selected based on specifications from the manufacturer or supplier.

(B) Impervious clothing covering the exposed areas of the body ( e.g., long pants, long sleeved shirt).

(iv) Owners or operators must demonstrate that each item of gloves and other clothing selected provides an impervious barrier to prevent direct dermal contact with NMP during normal and expected duration and conditions of exposure within the work area by evaluating the specifications from the manufacturer or supplier of the clothing, or of the material used in construction of the clothing, to establish that the clothing will be impervious to NMP alone, NMP-containing formulations, and in likely combination with other chemical substances in the work area.

(6) Respiratory protection:

(i) The owner or operator must supply a respirator in accordance with § 751.211(b) and ensure that all persons using NMP-containing products for those uses specified therein are using the provided respirators.

(ii) Owners or operators must provide respiratory protection in accordance with the provisions outlined in 29 CFR 1910.134(a) through (l) (except paragraphs (d)(1)(iii) and (d)(3)(i)(B)) and as specified in this paragraph (e). For the purposes of this paragraph (e), provisions in 29 CFR 1910.134(a) through (l) (except (d)(1)(iii) and (d)(3)(i)(B)) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.

(iii) The respiratory protection requirements in § 751.211(b) represent the minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the required respirator may be used.

(f) Workplace information and training. (1) The owner or operator must provide information and training for each person prior to or at the time of initial assignment to a job involving potential exposure to NMP.

(2) The owner or operator must ensure that information and training is presented in a manner that is understandable to each person required to be trained.

(3) The following information and training must be provided to all persons assigned to a job involving potential exposure to NMP:

(i) The requirements of this paragraph (f), as well as a means to access or obtain a copy of these requirements in the workplace;

(ii) The quantity, location, manner of use, release, and storage of NMP and the specific operations in the workplace that could result in exposure to NMP, particularly noting where there is potential for direct dermal contact or inhalation exposure with NMP;

(iii) The principles of safe use and handling of NMP and measures potentially exposed persons can take to protect themselves from NMP, including specific procedures the owner or operator has implemented to protect potentially exposed persons from exposure to NMP, such as appropriate work practices, emergency procedures, and PPE to be used;

(iv) Methods and observations that may be used to detect the presence or release of NMP in the workplace; and

(v) The health hazards of NMP in the workplace.

(4) The owner or operator must re-train each potentially exposed person annually to ensure that each such person maintains the requisite understanding of the principles of safe use and handling of NMP in the workplace.

(5) Whenever there are workplace changes, such as modifications of tasks or procedures or the institution of new tasks or procedures, that increase potential for direct dermal contact or inhalation exposures, the owner or operator must update the training as necessary to ensure that each potentially Start Printed Page 51192 exposed person has the requisite proficiency.

(a) Applicability. The provisions of this section apply to the workplaces engaged in the following conditions of use of NMP, unless otherwise indicated: (1) Processing incorporation into articles in paint additives and coating additives in transportation equipment manufacturing.

(i) Industrial and commercial use in paints, coatings, and adhesive removers, except for those used listed in § 751.217(a);

(ii) Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes, and powder coatings in surface preparation, except for those used listed in § 751.217(a);

(iii) Industrial and commercial use in paint additives and coating additives in construction, fabricated metal product manufacturing, machinery manufacturing, other manufacturing, paint and coating manufacturing, primary metal manufacturing, transportation equipment manufacturing, wholesale, and retail trade;

(vi) Industrial and commercial use in soldering materials.

(b) Prescriptive controls — Applicability. (1) The provisions of this paragraph (b) apply to any workplace engaged in the conditions of use listed in paragraph (a) of this section. (2) Personal Protective Equipment (PPE). (i) The provisions of this paragraph (b) apply after [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ] (ii) For the conditions of use listed in paragraphs (a)(1) and (a)(2)(ii) through (iv) of this section, owners or operators must ensure that all persons using NMP-containing products are provided with dermal protective equipment as required in § 751.209(e)(2) and (5), any NIOSH Approved® air-purifying respirator equipped with organic vapor cartridges or canisters (minimum APF 10) as required in § 751.209(e)(6), and training on proper use of PPE as required in § 751.209(e)(3) and (4).

(A) For the condition of use listed in paragraph (a)(2)(i) of this section, owners or operators must ensure that all persons using NMP-containing products are provided with dermal protective equipment as required in § 751.209(e)(2) and (5), any NIOSH Approved® air-purifying respirator equipped with organic vapor cartridges or canisters; any NIOSH Approved® powered air-purifying respirator equipped with organic vapor cartridges; or any NIOSH Approved® continuous flow supplied air respirator equipped with a hood or helmet (minimum APF 25) as required in § 751.209(e)(6), and training on proper use of PPE as required in § 751.209(e)(3) and (4).

(B) For the conditions of use listed in paragraphs (a)(2)(v) and (vi) of this section, owners or operators must ensure that all persons using NMP-containing products are provided with dermal protective equipment as required in § 751.209(e)(2) and (5) and training on proper use of PPE as required in § 751.209(e)(3) and (4).

(a) General records. After [DATE 60 DAYS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], all persons who manufacture, process, distribute in commerce, or engage in industrial or commercial use of NMP or NMP-containing products must maintain ordinary business records, such as invoices and bills-of-lading related to compliance with the prohibitions, restrictions, and other provisions of this subpart.

(b) Workplace Chemical Protection Program (WCPP) compliance —(1) DDCC compliance. Owners or operators subject to DDCC requirements described in § 751.209(b) must retain records of:

(i) Exposure control plan as described in § 751.209(c);

(ii) Dermal protection used by each potentially exposed person and PPE program implementation as described in § 751.209(e), including:

(A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle NMP or handle equipment or materials on which NMP may present and the type of PPE selected to be worn by each of these persons;

(B) The basis for specific PPE selection ( e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area);

(C) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE;

(D) Occurrence and duration of any direct dermal contact with NMP that occurs during any activity or malfunction at the workplace that causes direct dermal exposures to occur and/or glove breakthrough, and corrective actions to be taken during and immediately following that activity or malfunction to prevent direct dermal contact to NMP; and

(E) Training in accordance with § 751.209(e)(3).

(iii) Information and training provided by the regulated entity to each person prior to or at the time of initial assignment to a job involving potential direct dermal contact with NMP and any re-training as required in § 751.209(f).

(2) Workplace participation. Owners or operators must document the notice to and ability of any potentially exposed person to NMP direct dermal contact exposure to readily access the exposure control plans, facility exposure monitoring records, PPE program implementation, or any other information relevant to NMP exposure in the workplace. (c) Prescriptive requirements. Owners and operators subject to the requirements described in § 751.207 and § 751.211 must retain records of: (1) Documentation identifying implementation of and compliance with the concentration limits listed in § 751.207(b);

(2) Dermal protection used by each potentially exposed person as described in § 751.211(b) and PPE program implementation, as described in § 751.209(e); and

(3) Respiratory protection used by each potentially exposed person as described in § 751.211(b) and (vi) and PPE program implementation, as described in § 751.209(e).

(d) Additional recordkeeping for mission- or safety-critical uses of paint, coating, or adhesive removers or paints and coatings. (1) Owners and operators subject to the requirements described in § 751.217 must retain the following: (i) Each self-certification statement for each facility that is self-certifying, including:

(A) The written statement required by § 751.217(b)(2)(i); Start Printed Page 51193

(B) Printed name and signature, job classification, email address and phone number of the owner or operator who is self-certifying;

(C) Date of self-certification; and

(D) Name and address of the facility.

(ii) All records required by paragraphs (a) and (b) of this section.

(2) Sellers and distributors of NMP subject to the requirements described in § 751.217 must also retain the following:

(i) Invoices that include:

(A) Name of facility;

(B) Name of owner or operator who is self-certifying;

(C) Date of sale; and

(D) Quantity of NMP being purchased, and concentration by weight of NMP if applicable in NMP-containing products.

(ii) Self-certification statement for each purchase of NMP.

(iii) Copies of the downstream notifications required by § 751.217(b)(5).

(iv) Copies of the labels required by § 751.217(b)(6).

(e) Retention. Persons required to maintain records required under this section for a period of 5 years from the date that such records were generated. 751.215Downstream notification.

(a) Beginning on [DATE 2 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], each person who manufactures (including imports) NMP for any condition of use specified in §§ 751.209 and 751.211, except for those specified in § 751.217 must, prior to or concurrent with the shipment, notify companies to whom NMP is shipped, in writing, of the restrictions described in this subpart in accordance with paragraph (c) of this section.

(b) Beginning on [DATE 6 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], each person who processes or distributes in commerce NMP or any NMP-containing products for any condition of use specified in § 751.209 and § 751.211, except for those specified in § 751.217 must, prior to or concurrent with the shipment, notify companies to whom NMP is shipped, in writing, of the restrictions described in this subpart in accordance with paragraph (c) of this section.

(c) The notification required under paragraphs (a) and (b) of this section must occur by inserting the following text in section 1(c) and 15 of the Safety Data Sheet (SDS) provided with the NMP or with any NMP-containing product:

After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], this chemical/product cannot be distributed in commerce or processed with a concentration of NMP greater than 0.1% by weight for the following purposes: Processing incorporation into articles in lubricants and lubricant additives in machinery manufacturing; Industrial and commercial use in anti-freeze and de-icing products, automotive care products, and lubricants and greases; Industrial and commercial use in metal products not covered elsewhere and lubricant and lubricant additives including hydrophilic coatings; Industrial and commercial use in cleaning and degreasing, and cleaning and furniture care products, including wood cleaners and gasket removers; and Industrial and commercial uses in fertilizer and other agricultural chemical manufacturing-processing aids and solvents.

(a) General. To be eligible to use NMP in paint, coating, and adhesive removers and paints and coatings at concentrations higher than those prohibited under 751.207(b), regulated parties must comply with all conditions in this section. The following uses are covered by this section: (1) Import, processing, distribution in commerce, and use of paints and coatings with more than 45 percent by weight of NMP, for mission- or safety-critical components of aircraft, spacecraft, and vessels that are owned or operated by the U.S. Department of Defense and the National Aeronautics and Space Administration. (2) Import, processing, distribution in commerce, and use of paint, coating, and adhesive removers with more than 30 percent by weight of NMP for mission- or safety-critical components of aircraft, spacecraft, and vessels that are owned or operated by the U.S. Department of Defense and the National Aeronautics and Space Administration.

(b) Conditions —(1) Personnel and location. The commercial uses listed in paragraph (a) of this section must be performed by agency employees or agency contractor employees at locations controlled by the agency or the agency's contractor.

(2) Self-certification. The owner or operator purchasing and using NMP for the conditions of use listed in paragraph (a) of this section must self-certify each location controlled by the agency or the agency's contractor for those uses.

(i) The self-certification must include the following written statement:

(ii) The self-certification must also include the following:

(A) Printed name and signature, job classification, title, email address, and phone number of the owner or operator who is self-certifying;

(B) Date of self-certification;

(C) Name and address of the facility; and

(D) An indication of whether this is the facility's first purchase of NMP, after [DATE OF PUBLICATION OF THE FINAL RULE].

(iii) Owners or operators must provide a copy of the self-certification statement for each facility to the distributor from whom NMP is being purchased, for every purchase.

(iv) Distributors of NMP must review the self-certification statement to ensure it is appropriately completed to include the owner or operator's and the facility's information required by this section.

(3) Workplace chemical protection program. The owner or operator of the locations processing or engaging in the commercial uses listed in paragraph (a) of this section must comply with the Workplace Chemical Protection Program provisions in described in § 751.209.

(4) Recordkeeping. The owner or operator of the locations processing or engaging in the commercial uses listed in paragraph (b) of this section must comply with the recordkeeping requirements in § 751.213.

(5) Downstream notification. All importers, processors and distributors in commerce of NMP for the uses listed in paragraph (a) of this section must provide downstream notification of the restrictions on use of these products by adding the following language to sections 1(c) and 15 of the SDS:

After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER ], this chemical/product is and can only be distributed in commerce or processed for the following purposes: paints and coatings or paint, coating, or adhesive removal by the Department of Defense (DOD), the National Aeronautics and Space Administration (NASA), or their contractors, at Federal installations, Federal industrial facilities, or at Federal contractor facilities performing work only for DOD and NASA projects.

(6) Labeling. All processors and distributors in commerce of NMP or NMP-containing products for the conditions of use listed in paragraph (a) of this section must provide a label securely attached to each product. Label information must be prominently displayed and in an easily readable font size. Each label must contain the following text:

This product contains n-methylpyrrolidone (NMP), a chemical determined by the Environmental Protection Agency to present unreasonable risk of injury to health under Section 6 of the Toxic Substances Control Act, based on developmental and reproductive effects. This product containing NMP is restricted under 40 CFR part 751, subpart C . This product is only for sale and can only be used by the Department of Defense (DOD), the National Aeronautics and Space Administration (NASA), or their contractors, at Federal installations, Federal industrial facilities, or at Federal contractor facilities performing work only for DOD and NASA projects.

[ FR Doc. 2024-12643 Filed 6-13-24; 8:45 am]

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Guest Essay

The Moral Limits of Bankruptcy Law

By Melissa B. Jacoby

Ms. Jacoby is the author of the forthcoming book “Unjust Debts: How Our Bankruptcy System Makes America More Unequal.”

When Purdue Pharma filed for Chapter 11 bankruptcy in 2019 , it had over a billion dollars in the bank and owed no money to lenders. But it also had the Sacklers, its owners, who were eager to put behind them allegations that they played a leading role in the national opioid epidemic.

The United States Supreme Court is now considering whether the bankruptcy system should have given this wealthy family a permanent shield against civil liability. But there is a bigger question at stake, too: Why is a company with no lenders turning to the federal bankruptcy system in response to accusations of harm and misconduct?

The maker of OxyContin is one in a long line of companies that have turned Chapter 11 into a legal Swiss Army knife, tackling problems that are a mismatch for its rules. Managing costly and sprawling litigation through bankruptcy can be well intentioned. But Chapter 11 was designed around the goal of helping financially distressed businesses restructure loans and other contract obligations.

If companies instead turn to bankruptcy to permanently and comprehensively cap liability for wrongdoing — the objective not only of Purdue Pharma but also of many other entities over recent decades — they can shortchange the rights of individuals seeking accountability for corporate coverups of toxic products and other wrongdoing. And in a country that relies on lawsuits and the civil justice system to deter corporate malfeasance, permanently capping liability using a procedure focused primarily on debt and money could be making us less safe.

In 1978, a bipartisan group of lawmakers enacted sweeping reforms to American bankruptcy law. To enhance economic value and keep viable businesses alive for the benefit of workers and other stakeholders, these changes gave companies more protection and control in bankruptcy. This new bankruptcy code also made it easier to alter the legal rights of creditors during and after bankruptcy without their consent.

To provide more sweeping protection to a distressed but viable company, the new bankruptcy laws also expanded the definition of “creditor” to include people allegedly injured by the business. Yet the rules governing Chapter 11 were drafted primarily with loans and contracts, not large numbers of harmed individuals, in mind.

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