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

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.

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:

NMP.TSCA@epa.gov

.

For general information contact:

The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:

TSCA-Hotline@epa.gov.

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);

• 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);

• 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.

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

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

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,

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

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

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

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

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.

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

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

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

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,

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

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

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

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,

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

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

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;

(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 i

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