n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances Control Act (TSCA), 51134-51194 [2024-12643]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 116 (Friday, June 14, 2024)]
[Proposed Rules]
[Pages 51134-51194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12643]



[[Page 51133]]

Vol. 89

Friday,

No. 116

June 14, 2024

Part IV





Environmental Protection Agency





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40 CFR Part 751





n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances 
Control Act (TSCA); Proposed Rule

Federal Register / Vol. 89 , No. 116 / Friday, June 14, 2024 / 
Proposed Rules

[[Page 51134]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2020-0744; FRL-8330-02-OCSPP]
RIN 2070-AK85


n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances 
Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: 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.

DATES: 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.

ADDRESSES: 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 FURTHER INFORMATION CONTACT: 
    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].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

1. General
    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);

[[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);

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     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).
2. Applicability to Importers and Exporters
    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.

B. What is the Agency's authority for taking this action?

    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.

C. What action is the Agency taking?

    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.

[[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.

D. Why is the Agency taking this action?

    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

[[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.

E. What are the estimated incremental impacts of this action?

    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

[[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).

II. Background

A. Overview of n-Methylpyrrolidone

    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.

B. Regulatory Actions Pertaining to NMP

    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).

C. Consideration of Occupational Safety and Health Administration 
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA 
Risk Management Actions

    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,

[[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.
1. OSHA Requirements
    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.
a. General Duty Clause of the OSH 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.
b. OSHA Standards
    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

[[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.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
    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.).
a. Risk Characterization for Unreasonable Risk Determination
    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.
b. Risk Evaluation To Inform Risk Management 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.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
    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.
4. NMP and OSHA Requirements
    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

[[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.
5. NMP and Other Occupational Exposure Limits
    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).

D. Summary of EPA's Risk Evaluation Activities on NMP

    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

[[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.
1. 2020 Risk Evaluation
    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.
2. Revised Unreasonable Risk Determination
    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.
3. Fenceline Screening Analysis
    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

[[Page 51144]]

exposures are of no concern, is discussed in Unit VI.A.

III. Regulatory Approach

A. Background

    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.
1. Consultations
    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.

[[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.
2. Other Stakeholder Engagement
    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).
3. Children's Environmental Health
    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)

B. Regulatory Assessment of NMP

1. Description of Conditions of Use
    This unit describes the TSCA conditions of use that EPA proposes to 
regulate, including the conditions of use

[[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).
a. Manufacturing
    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.
b. Processing
    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.
c. Industrial and Commercial Use
    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

[[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

[[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.
d. Consumer Uses
    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.
e. Disposal
    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.
f. Terminology in This Proposed Rule
    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,

[[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).
2. Description of Unreasonable Risk Under the Conditions of Use
    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.
3. Description of TSCA Section 6 Requirements for Risk Management
    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

[[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.

IV. Proposed and Alternative Regulatory Actions

    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.

A. Proposed Regulatory Action

    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.
1. Prohibition of Certain Occupational Uses and Manufacturing, 
Processing, and Distribution in Commerce of NMP for Those Uses
    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

[[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.
2. Container Size Restrictions and Labeling Requirements
    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

[[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.
3. Workplace Chemical Protection Program (WCPP) for Certain Conditions 
of Use
a. Overview
    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
     Disposal.
    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,

[[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.
b. Direct Dermal Contact Control (DDCC) 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

[[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)).
c. Personal Protective Equipment (PPE) Program
    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

[[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.
d. General WCPP Requirements
    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;

[[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

[[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.
4. Prescriptive Controls
a. Overview
    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[supreg] 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[supreg] air-purifying respirator equipped with organic vapor 
cartridges or canisters; any NIOSH Approved[supreg] powered air-
purifying respirator equipped with NIOSH Approved[supreg] organic vapor 
cartridges; or any NIOSH Approved[supreg] 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.
b. Concentration Limits for Industrial and Commercial Uses
    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.
c. Workplace Requirements
    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

[[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.
d. Recordkeeping
    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).
e. Compliance Timeframes
    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.
5. Concentration Limits on NMP in Products for Consumer Use in 
Adhesives and Sealants in Glues and Adhesives, Including Lubricant 
Adhesives
    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

[[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.
6. Mission- or Safety-Critical Uses of NMP by DOD and NASA
a. Overview
    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.
b. Self-Certification Requirements
    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.
c. Recordkeeping and Downstream Notification
    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

[[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.
7. Other Requirements
a. Recordkeeping
    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.
b. Downstream Notification
    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.

B. Primary Alternative Regulatory Action

    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

[[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.
1. WCPP
    The primary alternative regulatory action described in this 
document includes a WCPP, including DDCC, for the following conditions 
of use:
     Manufacturing (domestic manufacturing);
     Manufacturing (import);
     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 lubricants and 
lubricant additives in machinery 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;
     Disposal;
     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 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 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
     Industrial and commercial uses in fertilizer and other 
agricultural chemical manufacturing-processing aids and solvents.
    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

[[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.
2. Prohibition
    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.

C. Overview of Conditions of Use and Proposed Regulatory Action and 
Alternative Regulatory Action

    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 use                          Action
------------------------------------------------------------------------
                                                            Primary
           Subcategory                  Proposed          alternative
                                    regulatory action        action
------------------------------------------------------------------------
Domestic manufacture.............  NMP WCPP..........  NMP WCPP.
Import...........................  NMP WCPP..........  NMP WCPP.
Processing as a reactant/          NMP WCPP..........  NMP WCPP.
 intermediate in plastic material
 and resin manufacturing and
 other non-incorporative
 processing.
Processing incorporation into      NMP WCPP..........  NMP WCPP.
 formulation, mixture or reaction
 products in multiple industrial
 sectors, including, but not
 limited to:
     Adhesives and
     sealant chemicals in
     adhesive manufacturing;

[[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      Prohibition.......  NMP WCPP.
 articles in lubricants and
 lubricant additives in machinery
 manufacturing.
Processing incorporation into      Prescriptive        NMP WCPP.
 articles in paint additives and    controls (45%
 coating additives in               CL+PPE).
 transportation equipment
 manufacturing.
Processing incorporation into      NMP WCPP..........  NMP WCPP.
 articles as a solvent (which
 become part of product
 formulation or mixture),
 including in textiles, apparel
 and leather manufacturing.
Processing incorporation into      NMP WCPP..........  NMP WCPP.
 articles in other sectors,
 including in plastic product
 manufacturing.
Processing by repackaging in       NMP WCPP..........  NMP WCPP.
 wholesale and retail trade.
Processing by recycling..........  NMP WCPP..........  NMP WCPP.
Industrial and commercial use in   Prescriptive        NMP WCPP.
 paints, coatings, and other        controls \1\ (30%
 adhesive removers.                 CL+PPE).
Industrial and commercial use in   Prescriptive        NMP WCPP.
 paints and coatings in lacquers,   controls \2\ (45%
 stains, varnishes, primers and     CL+PPE).
 floor finishes, and powder
 coatings in surface preparation.
Industrial and commercial use in   NMP WCPP..........  NMP WCPP.
 paint additives and coating
 additives in computer and
 electronic product manufacturing
 in electronic parts
 manufacturing.
Industrial and commercial use in   NMP WCPP..........  NMP WCPP.
 paint additives and coating
 additives in computer and
 electronic product manufacturing
 in semiconductor manufacturing.
Industrial and commercial use in   Prescriptive        NMP WCPP.
 paint additives and coating        controls (45%
 additives in construction,         CL+PPE).
 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   NMP WCPP..........  NMP WCPP.
 a solvent (for cleaning or
 degreasing) in electrical
 equipment, appliance and
 component manufacturing.
Industrial and commercial use as   NMP WCPP..........  NMP WCPP.
 a solvent (for cleaning or
 degreasing) in electrical
 equipment appliance and
 component manufacturing in
 semiconductor manufacturing.
Industrial and commercial use in   Prescriptive        NMP WCPP.
 ink, toner, and colorant           controls (5%
 products in printer ink and inks   CL+PPE).
 in writing equipment.
Industrial and commercial use in   NMP WCPP..........  NMP WCPP.
 processing aids, specific to
 petroleum production in
 petrochemical manufacturing, in
 oil and gas drilling, extraction
 and support activities, and in
 functional fluids (closed
 systems).
Industrial and commercial use in   Prescriptive        Prohibition.
 adhesives and sealants including   controls (45%
 binding agents, single component   CL+PPE).
 glues and adhesives, including
 lubricant adhesives and two-
 component glues and adhesives
 including some resins.
Industrial and commercial use in   Prescriptive        NMP WCPP.
 soldering materials.               controls (1%
                                    CL+PPE).
Industrial and commercial use in   Prohibition.......  NMP WCPP.
 anti-freeze and de-icing
 products, automotive care
 products, and lubricants and
 greases.
Industrial and commercial use in   Prohibition.......  NMP WCPP.
 metal products not covered
 elsewhere, and lubricant and
 lubricant additives including
 hydrophilic coatings.
Industrial and commercial use in   NMP WCPP..........  NMP WCPP.
 laboratory chemicals.
Industrial and commercial use in   NMP WCPP..........  NMP WCPP.
 lithium ion battery
 manufacturing.
Industrial and commercial use in   Prohibition.......  NMP WCPP.
 cleaning and degreasing, and
 cleaning and furniture care
 products, including wood
 cleaners and gasket removers.

[[Page 51164]]

 
Industrial and commercial use in   Prohibition.......  NMP WCPP.
 fertilizer and other
 agricultural chemical
 manufacturing, processing aids
 and solvents.
Consumer use in paint and coating  16 ounce container  Would not be
 removers.                          limit \5\ +         regulated.\4\
                                    labeling.
Consumer use in adhesive removers  16 ounce container  Would not be
                                    limit \5\ +         regulated.\4\
                                    labeling.
Consumer use in paints and         16 ounce container  Would not be
 coatings in lacquers, stains,      limit \5\ +         regulated.\4\
 varnishes, primers and floor       labeling.
 finishes.
Consumer use in paint additives    16 ounce container  Would not be
 and coating additives in paints    limit \5\ +         regulated.\4\
 and arts and crafts paints.        labeling.
Consumer use in adhesives and      Concentration       Prohibition.\3\
 sealants in glues and adhesives,   Limit (45% CL)
 including lubricant adhesives.     \6\.
Consumer use in automotive care    16 ounce container  Would not be
 products.                          limit \5\ +         regulated.\4\
                                    labeling.
Consumer use in cleaning and       16 ounce container  Would not be
 furniture care products,           limit \5\ +         regulated.\4\
 including wood cleaners and        labeling.
 gasket removers.
Consumer use in lubricant and      16 ounce (1 pint)   Would not be
 lubricant additives, including     container limit     regulated.\4\
 hydrophilic coatings.              \5\ + labeling.
Disposal.........................  NMP WCPP..........  NMP WCPP.
------------------------------------------------------------------------
\1\ 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.
\2\ 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.
\3\ Prohibit manufacture, processing, and distribution in commerce for
  the consumer use.
\4\ 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.
\5\ Proposed container size restrictions are intended to prevent
  diversion of consumer products to commercial users.
\6\ This is the only condition of use for consumers that contributes to
  the unreasonable risk from NMP.

V. Rationale for the Proposed Regulatory Action and Alternative 
Regulatory Action

    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.

A. Consideration of Risk Management Requirements Available Under TSCA 
Section 6(a)

1. Proposed Regulatory Action
a. Prohibition
    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

[[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,

[[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.
b. Container Size Restrictions
    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.

[[Page 51167]]

c. WCPP
    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

[[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,

[[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.
d. Prescriptive Controls
    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

[[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.
e. Concentration Limit for Consumer Use in Adhesives and Sealants
    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

[[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.
2. Alternative Regulatory Actions
    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.
3. Risk Management Requirements Considered But Not Proposed
    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

[[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.
4. Additional Considerations
    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

[[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.

B. Consideration of Alternatives in Deciding Whether To Prohibit or 
Substantially Restrict NMP

    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.

VI. TSCA Section 6(c)(2) Considerations

A. Health Effects of NMP and the Magnitude of Human Exposure to NMP

    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

[[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.

B. Environmental Effects of NMP and the Magnitude of Exposure of the 
Environment to NMP

    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.

C. Benefits of NMP for Various Uses

    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.

[[Page 51175]]

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
    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.
2. Costs and Benefits of the Proposed Regulatory Action and of the 
Alternative Regulatory Actions Considered by the Administrator
    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.
3. Cost Effectiveness of the Proposed Regulatory Action and Alternative 
Regulatory Actions Considered by the Administrator
    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

[[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).

VII. TSCA Section 9 Analysis, Section 14, and Section 26 Considerations

A. TSCA Section 9(a) Analysis

    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).

B. TSCA Section 9(b) Analysis

    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

[[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.

C. TSCA Section 14 Requirement

    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.

D. TSCA Section 26 Considerations

    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).

VIII. Requests for Comment

    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

[[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

[[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

[[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.

IX. References

    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.

[[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. https://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. https://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. https://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.

X. Statutory and Executive Order Reviews

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

A. Executive Orders 12866: Regulatory Planning and Review and 14094: 
Modernizing Regulatory Review

    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.

B. Paperwork Reduction Act (PRA)

    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

[[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.

C. Regulatory Flexibility Act (RFA)

    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.
1. Need for the Rule
    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.
2. Objectives and Legal Basis
    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.
3. Description and Number of Small Entities to Which the Rule Will 
Apply
    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.
4. Projected Compliance Requirements
    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

[[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.
Self-Certification-Related Information Generation, Recordkeeping, and 
Notification Requirements
    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.
a. Classes of Small Entities Subject to the Compliance Requirements
    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.
b. Professional Skills Needed To Comply
    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

[[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.
5. Relevant Federal Rules
    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 [deg]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 ([mu]g/day) and MADL for dermal exposure = 17,000 [mu]g/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).
6. Significant Alternatives to the Proposed Rule
    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

[[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).

D. Unfunded Mandates Reform Act (UMRA)

    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

[[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.

E. Executive Order 13132: Federalism

    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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    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

[[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.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    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.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    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.

I. National Technology Transfer and Advancement Act (NTTAA)

    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.

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

    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

[[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).

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, 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:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
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).

0
2. Amend Sec.  751.5 by adding in alphabetical order definitions for 
``Direct dermal contact'', ``Exposure group'', and ``Restricted area'' 
to read as follows:


Sec.  751.5  Definitions.

* * * * *
    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.
* * * * *
0
3. Add subpart C to read as follows:
Subpart C--n-Methylpyrrolidone
Sec.
751.201 General.
751.203 Definitions.
751.205 Prohibitions of manufacturing, processing, distribution in 
commerce, and use.
751.207 Concentration limits, container size limits, and labels
751.209 Workplace Chemical Protection Program.
751.211 Prescriptive workplace requirements.
751.213 Recordkeeping requirements.
751.215 Downstream notification.
751.217 Mission- or safety-critical uses of paint, coating, or 
adhesive removers or paints and coatings.

Subpart C--n-Methylpyrrolidone (NMP)


Sec.  751.201  General.

    (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.


Sec.  751.203  Definitions.

    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 
Sec.  751.213.


Sec.  751.205  Prohibitions of manufacturing, processing, distribution 
in commerce, and use.

    (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

[[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.


Sec.  751.207  Concentration limits, container size limits, and labels.

    (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.
    (2) Industrial and commercial conditions of use:
    (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 Sec.  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 Sec.  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.
    (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 (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.
    (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 (a)(2)(vi) 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.
    (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 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.
    (ii) More than 30 percent by weight of NMP for the condition 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 and for the condition of 
use listed in paragraph (a)(2)(vi) of this section.
    (c) Container size restrictions and labels. (1) After [DATE 12 
MONTHS AFTER THE DATE OF PUBLICATION

[[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:

    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.


Sec.  751.209  Workplace Chemical Protection program.

    (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 Sec.  751.205(a);
    (ii) The processing described in Sec.  751.207(a); and
    (iii) The processing described in Sec.  751.211(a).
    (4) All industrial and commercial use, except for the following:
    (i) Those industrial and commercial uses presented in Sec.  
751.205(a);
    (ii) Those industrial and commercial uses presented in Sec.  
751.207(a); and
    (iii) Those industrial and commercial uses presented in Sec.  
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

[[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 Sec.  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 Sec.  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 Sec.  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

[[Page 51192]]

exposed person has the requisite proficiency.


Sec.  751.211  Prescriptive workplace requirements.

    (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.
    (2) Industrial and commercial conditions of use:
    (i) Industrial and commercial use in paints, coatings, and adhesive 
removers, except for those used listed in Sec.  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 Sec.  
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;
    (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.
    (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 Sec.  751.209(e)(2) and 
(5), any NIOSH Approved[supreg] air-purifying respirator equipped with 
organic vapor cartridges or canisters (minimum APF 10) as required in 
Sec.  751.209(e)(6), and training on proper use of PPE as required in 
Sec.  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 Sec.  751.209(e)(2) and (5), any NIOSH Approved[supreg] 
air-purifying respirator equipped with organic vapor cartridges or 
canisters; any NIOSH Approved[supreg] powered air-purifying respirator 
equipped with organic vapor cartridges; or any NIOSH Approved[supreg] 
continuous flow supplied air respirator equipped with a hood or helmet 
(minimum APF 25) as required in Sec.  751.209(e)(6), and training on 
proper use of PPE as required in Sec.  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 Sec.  751.209(e)(2) and (5) and training on 
proper use of PPE as required in Sec.  751.209(e)(3) and (4).


Sec.  751.213  Recordkeeping requirements.

    (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 Sec.  751.209(b) must retain records of:
    (i) Exposure control plan as described in Sec.  751.209(c);
    (ii) Dermal protection used by each potentially exposed person and 
PPE program implementation as described in Sec.  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 Sec.  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 Sec.  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 Sec.  751.207 and Sec.  751.211 must retain 
records of: (1) Documentation identifying implementation of and 
compliance with the concentration limits listed in Sec.  751.207(b);
    (2) Dermal protection used by each potentially exposed person as 
described in Sec.  751.211(b) and PPE program implementation, as 
described in Sec.  751.209(e); and
    (3) Respiratory protection used by each potentially exposed person 
as described in Sec.  751.211(b) and (vi) and PPE program 
implementation, as described in Sec.  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 Sec.  
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 Sec.  751.217(b)(2)(i);

[[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 Sec.  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 Sec.  
751.217(b)(5).
    (iv) Copies of the labels required by Sec.  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 
Sec. Sec.  751.209 and 751.211, except for those specified in Sec.  
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 Sec.  751.209 and Sec.  751.211, except 
for those specified in Sec.  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.


Sec.  751.217  Mission- or safety-critical uses of paint, coating, or 
adhesive removers or paints and coatings.

    (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:

    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.

    (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 Sec.  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 
Sec.  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:


[[Page 51194]]


    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]
 BILLING CODE 6560-50-P