Proposed Rule2024-12643
n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 14, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[Federal Register Volume 89, Number 116 (Friday, June 14, 2024)]
[Proposed Rules]
[Pages 51134-51194]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12643]
[[Page 51133]]
Vol. 89
Friday,
No. 116
June 14, 2024
Part IV
Environmental Protection Agency
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40 CFR Part 751
n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances
Control Act (TSCA); Proposed Rule
Federal Register / Vol. 89 , No. 116 / Friday, June 14, 2024 /
Proposed Rules
[[Page 51134]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0744; FRL-8330-02-OCSPP]
RIN 2070-AK85
n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or the ``Agency'') is
proposing to address the unreasonable risk of injury to human health
presented by n-methylpyrrolidone (NMP) under its conditions of use as
documented in EPA's risk evaluation and risk determination for NMP
pursuant to the Toxic Substances Control Act (TSCA). NMP is a widely
used solvent in a variety of industrial, commercial, and consumer
applications including the manufacture and production of electronics
such as semiconductors, polymers, petrochemical products, paints and
coatings, and paint and coating removers. EPA determined that NMP
presents an unreasonable risk of injury to health due to the
significant adverse health effects associated with exposure to NMP,
including developmental post-implantation fetal loss from short-term
exposure and reduced fertility and fecundity from long-term exposure.
Additional adverse effects associated with exposure to NMP include
liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin
irritation, and sensitization. To address the identified unreasonable
risk, EPA is proposing to: prohibit the manufacture (including import),
processing, and distribution in commerce and use of NMP in several
occupational conditions of use; require worker protections through an
NMP workplace chemical protection program (WCPP) or prescriptive
controls (including concentration limits) for most of the occupational
conditions of use; require concentration limits on a consumer product;
regulate certain consumer products to prevent commercial use; and
establish recordkeeping, labeling, and downstream notification
requirements.
DATES: Comments must be received on or before July 29, 2024. Under the
Paperwork Reduction Act (PRA), comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before July 15, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0744, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets/">https://www.epa.gov/dockets/</a>.
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:
<a href="/cdn-cgi/l/email-protection#1e50534e304a4d5d5f5e7b6e7f30797168"><span class="__cf_email__" data-cfemail="78363528562c2b3b39381d0819561f170e">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#42161101036f0a2d362e2b2c27022732236c252d34"><span class="__cf_email__" data-cfemail="580c0b1b197510372c3431363d183d2839763f372e">[email protected]</span></a>.
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:
<bullet> Abrasive Product Manufacturing (NAICS Code 327910);
<bullet> Adhesive Manufacturing (NAICS Code 325520);
<bullet> Aerospace Product and Parts Manufacturing (NAICS Code
336400);
<bullet> Agriculture, Construction, and Mining Machinery
Manufacturing (NAICS Code 333100);
<bullet> Aircraft Manufacturing (NAICS Code 336411);
<bullet> All Other Automotive Repair and Maintenance (NAICS Code
811198);
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS Code
325199);
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS Code 325998);
<bullet> All Other Miscellaneous Electrical Equipment and Component
Manufacturing (NAICS Code 335999);
<bullet> All Other Miscellaneous Manufacturing (NAICS Code 339999);
<bullet> All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS Code 453998);
<bullet> All Other Plastics Product Manufacturing (NAICS Code
326199);
<bullet> All Other Specialty Trade Contractors (NAICS Code 238990);
<bullet> Alumina and Aluminum Production and Processing (NAICS Code
331300);
<bullet> Appliance Repair and Maintenance (NAICS Code 811412);
<bullet> Architectural and Structural Metals Manufacturing (NAICS
Code 332300);
<bullet> Art Dealers (NAICS Code 453920);
<bullet> Artificial and Synthetic Fibers and Filaments
Manufacturing (NAICS Code 325220);
<bullet> Audio and Video Equipment Manufacturing (NAICS Code
334300);
<bullet> Automobile Dealers (NAICS Code 441110);
<bullet> Automotive Body, Paint and Interior Repair and Maintenance
(NAICS Code 811121);
<bullet> Automotive Exhaust System Repair (NAICS Code 811112);
<bullet> Automotive Glass Replacement Shops (NAICS Code 811122);
<bullet> Automotive Oil Change and Lubrication Shops (NAICS Code
811191);
<bullet> Automotive Parts and Accessories Stores (NAICS Code
441310);
<bullet> Automotive Transmission Repair (NAICS Code 811113);
<bullet> Boiler, Tank, and Shipping Container Manufacturing (NAICS
Code 332400);
<bullet> Books Printing (NAICS Code 323117);
<bullet> Broadwoven Fabric Mills (NAICS Code 313210);
<bullet> Car Washes (NAICS Code 811192);
<bullet> Coating, Engraving, Heat Treating, and Allied Activities
(NAICS Code 332800);
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS Code 811310);
<bullet> Commercial and Institutional Building Construction (NAICS
Code 236220);
<bullet> Commercial and Service Industry Machinery Manufacturing
(NAICS Code 333300);
<bullet> Commercial Printing (except Screen and Books) (NAICS Code
323111);
<bullet> Commercial Screen Printing (NAICS Code 323113);
[[Page 51135]]
<bullet> Commercial, Industrial and Institutional Electric Lighting
Fixture Manufacturing (NAICS Code 335122);
<bullet> Communication Equipment Repair and Maintenance (NAICS Code
811213);
<bullet> Communications Equipment Manufacturing (NAICS Code
334200);
<bullet> Computer and Office Machine Repair and Maintenance (NAICS
Code 811212);
<bullet> Computer and Peripheral Equipment Manufacturing (NAICS
Code 334100);
<bullet> Computer Terminal and Other Computer Peripheral Equipment
Manufacturing (NAICS Code 334118);
<bullet> Consumer Electronics Repair and Maintenance (NAICS Code
811211);
<bullet> Cut Stock, Resawing Lumber, and Planing (NAICS Code
321912);
<bullet> Cutlery and Handtool Manufacturing (NAICS Code 332200);
<bullet> Dental Equipment and Supplies Manufacturing (NAICS Code
339114);
<bullet> Drywall and Insulation Contractors (NAICS Code 238310);
<bullet> Electric Lighting Equipment Manufacturing (NAICS Code
335100);
<bullet> Electrical Contractors and Other Wiring Installation
Contractors (NAICS Code 238210);
<bullet> Electrical Equipment Manufacturing (NAICS Code 335300);
<bullet> Engine, Turbine, and Power Transmission Equipment
Manufacturing (NAICS Code 333600);
<bullet> Executive Offices (NAICS Code 921110);
<bullet> Fabric Coating Mills (NAICS Code 313320);
<bullet> Facilities Support Services (NAICS Code 561200);
<bullet> Flooring Contractors (NAICS Code 238330);
<bullet> Fluid Power Cylinder and Actuator Manufacturing (NAICS
Code 333995);
<bullet> Footwear Manufacturing (NAICS Code 316210);
<bullet> Forging and Stamping (NAICS Code 332100);
<bullet> Foundries (NAICS Code 331500);
<bullet> Framing Contractors (NAICS Code 238130);
<bullet> Furniture Stores (NAICS Code 442110);
<bullet> General Automotive Repair (NAICS Code 811111);
<bullet> Glass and Glazing Contractors (NAICS Code 238150);
<bullet> Hardware Manufacturing (NAICS Code 332500);
<bullet> Hazardous Waste Treatment and Disposal (NAICS Code
562211);
<bullet> Highway, Street, and Bridge Construction (NAICS Code
237310);
<bullet> Home and Garden Equipment Repair and Maintenance (NAICS
Code 811411);
<bullet> Home Furnishing Merchant Wholesalers (NAICS Code 423220);
<bullet> Household Appliance Manufacturing (NAICS Code 335200);
<bullet> Independent Artists, Writers and Performers (NAICS Code
711510);
<bullet> Industrial Building Construction (NAICS Code 236210);
<bullet> Industrial Gas Manufacturing (NAICS Code 325120);
<bullet> Industrial Machinery Manufacturing (NAICS Code 333200);
<bullet> Investment Advice (NAICS Code 523930);
<bullet> Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
Code 331100);
<bullet> Lessors of Other Real Estate Property (NAICS Code 531190);
<bullet> Machine Shops; Turned Product; and Screw, Nut, and Bolt
Manufacturing (NAICS Code 332700);
<bullet> Manufacturing and Reproducing Magnetic and Optical Media
(NAICS Code 334600);
<bullet> Masonry Contractors (NAICS Code 238140);
<bullet> Materials Recovery Facilities (NAICS Code 562920);
<bullet> Medical Equipment and Supplies Manufacturing (NAICS Code
339100);
<bullet> Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS Code 332812);
<bullet> Metalworking Machinery Manufacturing (NAICS Code 333500);
<bullet> Miscellaneous Intermediation (NAICS Code 523910);
<bullet> Motor Vehicle Body and Trailer Manufacturing (NAICS Code
336200);
<bullet> Motor Vehicle Manufacturing (NAICS Code 336100);
<bullet> Motor Vehicle Parts Manufacturing (NAICS Code 336300);
<bullet> Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS Code 423120);
<bullet> Motor Vehicle Towing (NAICS Code 488410);
<bullet> Museums (NAICS Code 712110);
<bullet> Navigational, Measuring, Electromedical, and Control
Instruments Manufacturing (NAICS Code 334500);
<bullet> New Car Dealers (NAICS Code 441110);
<bullet> New Housing For-Sale Builders (NAICS Code 236117);
<bullet> New Multifamily Housing Construction (except For-Sale
Builders) (NAICS Code 236116);
<bullet> New Single-family Housing Construction (Except For-Sale
Builders) (NAICS Code 236115);
<bullet> Nitrogenous Fertilizer Manufacturing (NAICS Code 325311);
<bullet> Nonferrous Metal (except Aluminum) Production and
Processing (NAICS Code 331400);
<bullet> Non-upholstered Wood Household Furniture Manufacturing
(NAICS Code 337122);
<bullet> Office Administrative Services (NAICS Code 561110);
<bullet> Oil and Gas Pipeline and Related Structures Construction
(NAICS Code 237120);
<bullet> Other Aircraft Part and Auxiliary Equipment Manufacturing7
(NAICS Code 336413);
<bullet> Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS Code 811118);
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS Code
325180);
<bullet> Other Building Equipment Contractors (NAICS Code 238290);
<bullet> Other Chemical and Allied Products Merchant Wholesalers
(NAICS Code 424690);
<bullet> Other Concrete Product Manufacturing (NAICS Code 327390);
<bullet> Other Construction Material Merchant Wholesalers (NAICS
Code 423390);
<bullet> Other Electrical Equipment and Component Manufacturing
(NAICS Code 335900);
<bullet> Other Electronic and Precision Equipment Repair and
Maintenance (NAICS Code 811219);
<bullet> Other Equipment and Component Manufacturing (NAICS Code
335900);
<bullet> Other Fabricated Metal Product Manufacturing (NAICS Code
332900);
<bullet> Other Foundation, Structure, and Building Exterior
Contractors (NAICS Code 238190);
<bullet> Other General Purpose Machinery Manufacturing (NAICS Code
333900);
<bullet> Other Heavy and Civil Engineering Construction (NAICS Code
237990);
<bullet> Other Industrial Machinery Manufacturing (NAICS Code
333249);
<bullet> Other Measuring and Controlling Device Manufacturing
(NAICS Code 334519);
<bullet> Other Nonhazardous Waste Treatment and Disposal (NAICS
Code 562219);
<bullet> Other Personal and Household Goods Repair and Maintenance
(NAICS Code 811490);
<bullet> Other Professional Equipment and Supplies Merchant
Wholesalers (NAICS Code 423490);
<bullet> Paint and Coating Manufacturing (NAICS Code 325510);
<bullet> Painting and Wall Covering Contractors (NAICS Code
238320);
<bullet> Paper Bag and Coated and Treated Paper Manufacturing
(NAICS Code 322220);
<bullet> Pesticide and Other Agricultural Chemical Manufacturing
(NAICS Code 325320);
<bullet> Petrochemical Manufacturing (NAICS Code 325110);
<bullet> Petroleum and Petroleum Products Merchant Wholesalers
(except Bulk Stations and Terminals) (NAICS Code 424720);
[[Page 51136]]
<bullet> Petroleum Bulk Stations and Terminals (NAICS Code 424710);
<bullet> Petroleum Lubricating Oil and Grease Manufacturing (NAICS
Code 324191);
<bullet> Petroleum Refineries (NAICS Code 324110);
<bullet> Plastics Material and Resin Manufacturing (NAICS Code
325211);
<bullet> Plumbing, Heating, and Air-Conditioning Contractors (NAICS
Code 238220);
<bullet> Polish and Other Sanitation Good Manufacturing (NAICS Code
325612);
<bullet> Poured Concrete Foundation and Structure Contractors
(NAICS Code 238110);
<bullet> Power and Communication Line and Related Structures
Construction (NAICS Code 237130);
<bullet> Railroad Rolling Stock Manufacturing (NAICS Code 336500);
<bullet> Residential Remodelers (NAICS Code 236118);
<bullet> Reupholstery and Furniture Repair (NAICS Code 811420);
<bullet> Roofing Contractors (NAICS Code 238160);
<bullet> Roofing, Siding, and Insulation Material Merchant
Wholesalers (NAICS Code 423330);
<bullet> Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS Code 334511);
<bullet> Semiconductor and Other Electronic Component Manufacturing
(NAICS Code 334400);
<bullet> Semiconductor and Related Device Manufacturing (NAICS Code
334413);
<bullet> Semiconductor Machinery Manufacturing (NAICS Code 333242);
<bullet> Service Establishment Equipment and Supplies Merchant
Wholesalers (NAICS Code 423850);
<bullet> Ship Building and Repairing (NAICS Code 336611);
<bullet> Siding Contractors (NAICS Code 238170);
<bullet> Sign Manufacturing (NAICS Code 339950);
<bullet> Site Preparation Contractors (NAICS Code 238910);
<bullet> Soap and Other Detergent Manufacturing (NAICS Code
325611);
<bullet> Solid Waste Combustors and Incinerators (NAICS Code
562213);
<bullet> Solid Waste Landfill (NAICS Code 562212);
<bullet> Sporting Goods Stores (NAICS Code 451110);
<bullet> Spring and Wire Product Manufacturing (NAICS Code 332600);
<bullet> Steel Product Manufacturing from Purchased Steel (NAICS
Code 331200);
<bullet> Storage Battery Manufacturing (NAICS Code 335911);
<bullet> Structural Steel and Precast Concrete Contractors (NAICS
Code 238120);
<bullet> Support Activities for Printing (NAICS Code 323120);
<bullet> Testing Laboratories (NAICS Code 541380);
<bullet> Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS Code 326150);
<bullet> Used Car Dealers (NAICS Code 441120);
<bullet> Used Merchandise Stores (NAICS Code 453310);
<bullet> Ventilation, Heating, Air-Conditioning, and Commercial
Refrigeration Equipment Manufacturing (NAICS Code 333400);
<bullet> Water and Sewer Line and Related Structures Construction
(NAICS Code 237110); and
<bullet> 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
(<a href="https://www.epa.gov/tsca-import-export-requirements">https://www.epa.gov/tsca-import-export-requirements</a>). Persons who
import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127 (see also 19 CFR 127.28). Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that NMP presents an
unreasonable risk of injury to health, without consideration of costs
or other non-risk factors, including an unreasonable risk to
potentially exposed or susceptible subpopulations (PESS) identified as
relevant to the 2020 Risk Evaluation for NMP by EPA, under the
conditions of use (Refs. 1, 2). The term ``conditions of use'' is
defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the
circumstances under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of. A detailed description of the
conditions of use that EPA evaluated in reaching its determination that
NMP presents an unreasonable risk is in Unit III.B.1. EPA notes that
all TSCA conditions of use of NMP are subject to this proposal.
Accordingly, to address the unreasonable risk, EPA is proposing, under
TSCA section 6(a), to:
(i) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of NMP for five occupational
conditions of use, as described in Unit IV.A.1.;
(ii) Require container size limits and labeling requirements for
the manufacture (including import), processing, and distribution in
commerce of NMP for seven consumer uses, as described in Unit IV.A.2.;
(iii) Require prescriptive controls, including concentration limits
and personal protective equipment (PPE) for seven occupational
conditions of use, as described in Unit IV.A.4.;
(iv) Require strict workplace controls, including an NMP WCPP, that
would include requirements to prevent direct dermal contact with NMP,
for all other occupational conditions of use, as described in Unit
IV.A.3, including the commercial use of paints and coatings and paint,
coating, and adhesive removers containing high concentrations of NMP in
uses essential to the missions of the Department of Defense (DOD) and
National Aeronautics and Space Administration (NASA);
(v) Require a concentration limit on NMP for the import,
processing, and distribution in commerce of one consumer use, as
described in Unit IV.A.5.;
(vi) Establish recordkeeping and downstream notification
requirements, as described in Unit IV.A.7.
[[Page 51137]]
In addition, EPA is proposing to amend the general provisions of 40
CFR part 751, subpart A, to define the following terms so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751: ``Direct dermal
contact,'' ``Exposure group,'' and ``Restricted area.'' EPA seeks
public comment on all aspects of this proposal. These definitions may
be codified in another rule under 40 CFR part 751 prior to the
publication of the final rulemaking for NMP. EPA seeks public comment
on all aspects of this proposal.
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' NMP was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in December 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in December 2022 (Ref.
3), determining that NMP, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. As a
result, EPA is proposing to take action to the extent necessary so that
NMP no longer presents such risk. The unreasonable risk is described in
Unit III.B.2. and the conditions of use EPA evaluated in reaching its
conclusion that NMP presents unreasonable risk are described in Unit
III.B.1.
NMP's hazards are well established. EPA's 2020 Risk Evaluation for
NMP considered the hazards associated with exposure to NMP and
determined that NMP presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to NMP. Some of the risks of adverse effects from NMP exposure may be
acute and experienced for only a short duration. However, certain short
duration exposures can result in irreversible impacts--such as post-
implantation fetal loss. Other risks may be chronic and result in long-
term impacts that are also irreversible. As described in the 2020 Risk
Evaluation for NMP, post-implantation fetal loss and reduced fertility
and fecundity are the most representative adverse effects of NMP
exposure (Ref. 1). Other significant adverse effects include liver
toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation,
and sensitization. EPA is proposing requirements so that NMP would no
longer present unreasonable risk to human health, including PESS.
EPA is proposing to ban several occupational conditions of use of
NMP, such as processing of NMP for incorporation into articles in
lubricants and as a lubricant additive in machinery manufacturing, and
industrial and commercial use of NMP in anti-freeze and de-icing
products, automotive care products, and lubricants, and greases. For
some of these conditions of use, EPA has not identified any current use
of NMP (e.g., in antifreeze, de-icing products, and lubricants); for
most others, EPA has identified possible alternatives in the
alternative assessment (Ref. 4). The uses that EPA proposes to prohibit
comprise an estimated 18% of the current production volume of NMP. EPA
is not proposing a complete ban on NMP. EPA determined that most
consumer uses do not contribute to the unreasonable risk for NMP,
largely due to the generally low concentration of NMP in consumer
products and the infrequent use by consumers of those products (Ref.
1). However, the commercial use of the same types of products does
contribute to the unreasonable risk because they generally contain
higher concentrations of NMP and are used more frequently in commercial
settings. Therefore, EPA is proposing to regulate these consumer
products in a manner that will help ensure that these products are not
diverted to commercial use, as is further described in Unit V.A.1.a.
This rulemaking also proposes to allow certain uses of NMP to
continue, provided that sufficient worker protection measures and
stringent controls are in place to prevent direct dermal contact to NMP
and address the unreasonable risk driven by direct dermal contact for
most of the occupational conditions of use. For many of the
occupational conditions of use, EPA is proposing strict workplace
controls under a WCPP. These conditions of use include the
manufacturing of NMP, processing NMP as a reactant or intermediate in
plastic material and resin manufacturing and other non-incorporative
processing and use of NMP as a laboratory chemical. These also include
the use of NMP in the manufacture of specialized electronics, such as
magnet wire, semiconductors, and lithium-ion batteries used in a wide
variety of applications including aerospace vehicles or electronic
devices, or the use of NMP in petrochemical manufacturing as a
processing aid in lubricant extraction. These conditions of use
comprise an estimated 44% of the current production volume of NMP. In
many of these industries, EPA expects that facilities will already have
in place the types of exposure controls that EPA proposes to require.
For example, EPA understands that most workplaces using NMP in
semiconductor manufacturing already have stringent controls in place
that reduce workplace exposures. For other conditions of use, because
EPA does not believe or have specific information demonstrating that
direct dermal contact can reasonably be prevented, and expects the
application method, such as spray application, to increase the
contribution to the unreasonable risk from inhalation exposure, EPA is
proposing limits on the weight fraction of NMP in formulated products
in combination with personal protective equipment (PPE) and other
workplace controls to address the unreasonable risk. These conditions
of use include the commercial use of NMP in certain formulations,
including various coatings, such as paint, adhesives, sealants, inks,
and soldering materials in a variety of applications and their
associated removers. These conditions of use comprise an estimated 37%
of the current production volume of NMP. EPA is also proposing a limit
on the weight fraction of NMP in one consumer use of NMP to mitigate
the unreasonable risk to consumers from the use of NMP in adhesives and
sealants.
As noted earlier, the conditions of use that EPA is proposing to
ban comprise an estimated 18% of the current production volume of NMP.
Of the conditions of use that would not be prohibited, EPA expects the
production volume for certain conditions of use to decline over time.
For example, EPA expects the industrial and commercial use of NMP in
paints and coatings to decline over time as formulators either
reformulate to a lower concentration of NMP or away from NMP,
especially as the requirement to meet strict workplace controls could
result in a transition in many workplaces away from NMP to other
chemical alternatives, such as those identified in the alternative
analysis (Ref. 4). For other conditions of use, EPA expects the
production volume to increase over time. For example, EPA expects the
industrial and commercial use of NMP in the manufacture of specialized
electronics, including semiconductors and lithium ion
[[Page 51138]]
batteries, to increase as the global demand for electronic devices
increases.
EPA recognizes that some occupational conditions of use are
important for national security applications or for other critical or
essential uses for which no technically or economically feasible safer
alternatives have been identified. While EPA has identified that
prescriptive controls--including limiting the weight fraction of NMP in
paints, coatings, or paint and coating removers or adhesive removers--
could address the unreasonable risk, EPA also understands that DOD and
NASA use high concentrations of NMP in uses critical to their missions.
In the context of DOD and NASA use, EPA expects that the exposure
controls that could be put into place under the WCPP could address the
unreasonable risk. As a result, EPA is proposing that the WCPP could be
used for specific DOD and NASA uses of high concentrations of NMP from
the proposed prescriptive workplace controls for industrial and
commercial uses of NMP in paints and coatings and for industrial and
commercial uses of NMP in paint, coating, and adhesive removers. More
information about these conditions of use, and their continuance to
ensure aviation, including space vehicles, and military readiness is in
Unit V.A.1.c.iii. EPA emphasizes that information available to EPA does
not indicate that commercial users other than DOD or NASA use such high
concentrations of NMP, or that they have a need for similar paints or
coatings, or paint, coating, or adhesive removal. More information and
EPA's requests for comment on these conditions of use is in Unit
V.A.1.c.iii.
The 2020 Risk Evaluation for NMP assessed the risk of injury to
health from exposure to NMP from the combination of several routes of
exposure, including dermal, inhalation, and vapor through skin
intrusion. The 2020 Risk Evaluation for NMP also compared the relative
exposures from these pathways with and without direct liquid contact.
Table 4-54 in the 2020 Risk Evaluation shows the calculated results,
which show that for most, but not all conditions of use that 99-100% of
exposure to NMP is due to dermal contact with liquid. EPA identified
unreasonable risk for NMP predominately due to the dermal exposure
pathway, as discussed in Units III.B.2. Thus, EPA has not identified
and is not proposing to set an Existing Chemical Exposure Limit (ECEL)
for NMP because such a level would only account for risk resulting from
the inhalation pathway. Addressing inhalation risks alone would not
mitigate the unreasonable risk from NMP. EPA's consideration of an ECEL
for NMP is described further in in Unit V.A.3.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis of the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 5). As described in more detail in the Economic
Analysis (Ref. 5) and in Units VI.D. and X.D., EPA's analysis of the
incremental monetized costs of this proposed rule is estimated to be
$396 million annualized over 20 years at a 3% discount rate and $397
million annualized over 20 years at a 7% discount rate. These costs
take into consideration compliance with implementation of a WCPP, which
would include dermal controls to prevent direct dermal contact,
applicable PPE requirements including as part of prescriptive controls
requirements, and costs for reformulation and container size
restrictions of numerous products. Cost estimates by use category are
provided in the Economic Analysis Table 7-36 (Ref. 5). The most notable
unquantified costs include possible costs from prohibition of use of
NMP for certain conditions of use as changes in labor time or
differences in efficacy for a specific firm's use are unknown to EPA.
Unquantified costs and other uncertainties in the cost analyses are
described more fully in section 7.10 of the Economic Analysis (Ref. 5).
The actions proposed in this rulemaking are expected to achieve
significant health benefits for the American public, most of which,
while tangible and significant, cannot at present be monetized
primarily due to a lack of applicable dose-response functions, which
are the relationships between exposures and any incremental adverse
effects. This issue is not unique to EPA and is a government-wide issue
for many noncancer endpoints. EPA is requesting public comment on
methodologies for developing noncancer human dose-response curves and
valuation methods for the health endpoints identified for NMP in the
Risk Evaluation, specifically willingness to pay studies. Non-monetized
benefits include risk reduction of developmental and reproductive
effects, liver toxicity, kidney toxicity, immunotoxicity,
neurotoxicity, irritation, and sensitization. (Ref. 5) While the
benefits to human health associated with risk reduction of
developmental and reproductive effects, liver toxicity, kidney
toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization
cannot be monetized at present, reductions in occurrence of these
conditions clearly have monetary value to society. The importance of
these reductions in occurrence should not be diminished or dismissed
simply because EPA currently lacks the analytical tools to precisely
monetize the positive societal impacts of this proposed regulation.
Human health risks were found at both chronic and acute exposure
levels. Rather than accumulating over a lifetime, risks were found for
workers exposed to NMP during the course of a workweek, or five days.
The 2020 Risk Evaluation assumed one day of exposure for acute
scenarios, and five days of exposure per week for chronic scenarios.
Blood concentrations of NMP are expected to be eliminated over the
course of a weekend with no exposure to NMP.
The 2020 Risk Evaluation for NMP identified developmental effects
as the most representative adverse effects of acute NMP exposure. EPA
specified post-implantation loss as the critical effect of acute
exposures over the course of a day. Post-implantation loss also
referred to as fetal death or fetal mortality includes miscarriage,
spontaneous abortion, or stillbirth, depending on when in the pregnancy
it occurs. Fetal death may result from a single maternal exposure to
NMP at a developmentally critical period (Ref. 1). Exposure to NMP
during a single day (over 8 hours) was found to present risks of fetal
death; further information is in section 3.2.3 of the 2020 Risk
Evaluation (Ref. 1). While there are some estimates of the cost of
medical treatment for miscarriage and stillbirth, there are no
willingness-to-pay estimates of the value of reduced risk of fetal
death. It is very likely that willingness-to-pay would be much higher
than the costs of medical treatment alone; further information is in
section 8.5.1 of the Economic Analysis (Ref. 5). The impacts of fetal
death, including miscarriage or stillbirth, include mental health
impacts, such as depression and anxiety on the woman experiencing the
death of a fetus, and can also impact partners and spouses (Ref. 5).
Mental health research has consistently identified both miscarriage
(defined as fetal death occurring before the 20th week of gestation)
and stillbirth (defined as fetal death occurring after the 20th week of
gestation) as a significant emotional burden exhibited as anxiety and
depression that can persist; research suggests women and men feel
effects for
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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,
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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
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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
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developing risk management actions in general, and specifically when
determining if and how regulated entities may meet a risk-based
exposure limit for NMP. The hierarchy of controls is a prioritization
of exposure control strategies from most preferred to least preferred
techniques. The control strategies include elimination of the hazard,
substitution with a less hazardous substance, engineering controls,
administrative controls such as training or exclusion zones with
warning signs, and, finally, use of PPE (Ref. 8). Under the hierarchy
of controls, the use of respirators and dermal PPE should only be
considered after all other steps have been taken to reduce exposures.
As discussed in Units IV.A. and V.A.1., EPA's risk management approach
would not rely solely or primarily on the use of respirators and dermal
PPE to address unreasonable risk to workers. Instead, EPA is proposing
prohibitions for several conditions of use and a WCPP for most
occupational conditions of use, including requirements to prevent
direct dermal contact with NMP, which is the exposure route of most
concern. The WCPP is discussed in full in Units IV.A.2. and V.A.1.b.
and would require consideration of the hierarchy of controls before use
of PPE. While EPA is proposing prescriptive controls for some
occupational conditions of use, these do not solely rely on PPE for
worker protection. Instead, EPA's proposed requirements would
incorporate additional controls, such as concentration limits, to
reduce exposures in alignment with the hierarchy of controls.
There is no chemical-specific OSHA standard or PEL for NMP.
Similarly, EPA is not proposing an ECEL for NMP because the proportion
of the exposure largely driving the unreasonable risk to workers is due
to dermal contact with liquid NMP (Ref. 1) and an ECEL would only
address risk from inhalation and vapor-through-skin (dermal exposure to
vapor but not direct dermal contact with a liquid) exposures without
accounting for the risk from direct dermal exposure. This is described
in more detail in Unit V.A.3. In accordance with the approach described
earlier in Unit II.C.3., EPA intends for this regulation to be as
consistent as possible with the existing OSHA standards, with
additional requirements as necessary to address the unreasonable risk.
5. NMP and Other Occupational Exposure Limits
EPA is aware of several occupational exposure limits (OELs) for
NMP, including the ones described in this unit. The 2014 California
Division of Occupational Safety and Health (Cal/OSHA) PEL for NMP is 1
ppm as an 8-hour TWA, along with a skin notation (California Code of
Regulations, title 8, Section 5155). In the 2007 Occupational Health
Hazard Risk Assessment Project for California, a range of occupational
exposure limits (identified as a cREL in the document) for NMP were
proposed, ranging from 0.4 to 5 ppm based on various options for
duration adjustment and cumulative uncertainty factors (UFs). The cRELs
were derived from decreased fetal and pup weight observed in Solomon et
al, 1995 (Ref. 9). While this study was discussed in the 2020 Risk
Evaluation for NMP, EPA did not select it for the point of departure
(POD) derivation due to uncertainties about the actual doses achieved
at the highest exposure and methodological inconsistencies with testing
guidelines. Additionally, it was not the most sensitive chronic POD
based on physiologically-based pharmacokinetic (PBPK) model internal
dose metrics (Ref. 1).
The 8-hour TWA 2021 Occupational Alliance for Risk Science (OARS)
Workplace Environmental Exposure Level (WEEL) for NMP is 15 ppm with a
skin notation because of the ability of NMP to be absorbed through the
skin, and the short-term TWA is 30 ppm (Ref. 10). The WEEL was based on
PBPK modeling of maternal and developmental toxicity from Saillenfait
et al., 2003, (Ref. 11) which was the basis of the acute point of
departure in the 2020 Risk Evaluation for NMP. While OARS reviewed data
from the Exxon, 1991 (Ref. 12) study for decreased male fertility that
is the basis of EPA's chronic POD, those data were not included in the
WEEL calculation.
The European Chemicals Agency (ECHA) restricts the use of NMP under
the 2018 EU REACH restriction 71 with three conditions (Ref. 13). The
conditions are: (1) NMP shall not be placed on the market as a
substance on its own or in mixtures in concentrations greater than 0.3%
after May 9, 2020, unless manufacturers, importers and downstream users
have included chemical safety reports and Safety Data Sheets (SDSs)
with Derived No Effect Levels (DNELs) relating to workers' exposures of
14.4 mg/m3 (equivalent to 3.5 ppm) for exposure by inhalation and 4.8
mg/kg/day for dermal exposure; (2) NMP shall not be manufactured, or
used, as a substance on its own or in mixtures in a concentration equal
to or greater than 0.3% after May 9, 2020 unless manufacturers and
downstream users take the appropriate risk management measures and
provide the appropriate operational conditions to ensure that exposure
of workers is below the DNELs specified in this paragraph; and (3) the
restrictions specified in this paragraph shall apply from May 9, 2024,
to placing on the market for use, or use, as a solvent or reactant in
the process of coating wires.
The ECHA DNELs are based on systemic developmental effects in rats.
The inhalation DNEL was based on no effects observed at the highest
dose in Lee at al., 1987, (Ref. 14) and adjusted to a human equivalent
concentration to result in the DNEL value. The dermal DNEL is 4.8 mg/
kg-day based on a dermal no observed adverse effect level of 237 mg/kg
for developmental toxicity in rats. Decreased live fetuses per litter,
increased resorptions, and decreased fetal weights were observed at the
high dose of 750 mg/kg. This DNEL is within the range of the estimated
equivalent value based on PODs derived in the EPA risk evaluation or
fenceline assessment (Refs. 15, 16).
D. Summary of EPA's Risk Evaluation Activities on NMP
In 2015, prior to amended TSCA, EPA published an NMP risk
assessment of the occupational and consumer use of NMP in paint
strippers, uses with high potential for exposure to consumers and
workers (Ref. 17). In January 2017, EPA issued a proposed rule under
TSCA section 6 (82 FR 7464, January 17, 2017) (FRL-9958-57), to address
risks that EPA had preliminarily identified for workers and consumers
from use of methylene chloride and NMP in paint and coating removal. In
March 2019, EPA issued a final rule under TSCA section 6 (84 FR 11420,
March 27, 2019) (FRL-9989-29), to address unreasonable risk from
methylene chloride in consumer paint and coating removal. In January
2021, EPA withdrew the portion of the proposed rule under TSCA section
6 that included NMP (86 FR 3932, January 15, 2021) (FRL-10018-67). In
December 2016, EPA selected NMP as one of the first 10 chemicals for
risk evaluation under TSCA section 6 (81 FR 91927, December 19, 2016)
(FRL-9956-47). EPA published the scope of the NMP risk evaluation in
July 2017 (81 FR 31592, July 7, 2017) (FRL-9963-57), and, after
receiving public comments, published the problem formulation in June
2018 (83 FR 26998, June 11, 2018) (FRL-9978-40). In December 2019, EPA
published a draft risk evaluation (84 FR 60087, November 7, 2019) (FRL-
10003-71), and after public comment and peer review by the Science
Advisory Committee on Chemicals (SACC), published the 2020 Risk
Evaluation for NMP in December
[[Page 51143]]
2020 in accordance with TSCA section 6(b) (85 FR 86558, December 30,
2020) (FRL-10017-18). EPA subsequently issued a draft revised TSCA
unreasonable risk determination for NMP (87 FR 39511, July 1, 2022)
(FRL-9943-01-OCSPP), and after public notice and receipt of comments,
published a final revised Unreasonable Risk Determination for NMP (87
FR 77596, December 19, 2022) (FRL-9943-02-OCSPP). The 2020 Risk
Evaluation for NMP and supplemental materials are in docket EPA-HQ-
OPPT-2019-0235, with the December 2022 final revised unreasonable risk
determination and additional materials supporting the risk evaluation
process in docket EPA-HQ-OPPT-2016-0743, on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for NMP, EPA evaluated risks associated
with 37 conditions of use within the following categories: manufacture
(including import), processing, distribution in commerce, industrial
and commercial use, consumer use, and disposal. Descriptions of these
conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for NMP
identified significant adverse health effects associated with exposure
to NMP, including developmental effects from acute inhalation and
dermal exposures, and reproductive effects from inhalation and dermal
exposures to NMP. A further discussion of the hazards of NMP is in Unit
III.B.2. The 2020 Risk Evaluation updated the hazard points of
departure (POD) from the draft risk evaluation and 2015 risk assessment
based on updated analyses performed in response to peer review
comments. Updated quantitative analyses of additional studies and
endpoints did not lead to a revised chronic POD, which remained at 183
hr-mg/L blood area-under-the curve (AUC), based on decreased male
fertility. In contrast, updating the quantitative analyses of acute
studies resulted in a revision of the acute POD from 216 mg/L to 437
mg/L peak blood concentration, which resulted in some changes to acute
risk estimates, which impacted the unreasonable risk determination.
Notably, with the updated POD, the consumer risk calculations resulted
in identification of fewer conditions of use contributing to the
unreasonable risk. EPA revised its determination regarding the
contribution to unreasonable risk and did not identify the consumer use
of NMP in paint and coating removers or the consumer use of NMP in
cleaning and furniture care products as contributing to the
unreasonable risk from NMP. This is discussed further in section 5.3 of
the 2020 Risk Evaluation which presented an update to the findings from
the 2015 risk assessment.
2. Revised Unreasonable Risk Determination
EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the 2020 Risk Evaluation
for NMP, to ensure that the risk evaluations upon which risk management
decisions are made, better align with TSCA's objective of protecting
human health and the environment. For NMP, EPA revised the original
unreasonable risk determination based on the 2020 Risk Evaluation for
NMP and issued a final revised unreasonable risk determination in
December 2022 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for NMP pursuant to TSCA section 6(b) and consistent
with Executive Order 13990 (entitled ``Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis'') and
other Administration priorities (Refs. 18, 19, and 20). The revisions
consisted of making the risk determination based on the whole chemical
substance instead of by individual conditions of use (which resulted in
the revised risk determination superseding the prior ``no unreasonable
risk'' determinations and withdrawing the associated TSCA section
6(i)(1) ``no unreasonable risk'' order) and clarifying that the risk
determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE (Ref. 2). In determining
whether NMP presents unreasonable risk under the conditions of use, EPA
considered relevant risk-related factors, including, but not limited
to: the effects of the chemical substance on health (including non-
cancer risks) and human exposure to the substance under the conditions
of use (including duration, magnitude and frequency of exposure); the
effects of the chemical substance on the environment and environmental
exposure under the conditions of use; the population exposed (including
any PESS); the severity of hazard (including the nature of the hazard,
the irreversibility of the hazard); and uncertainties. EPA also
considered the Agency's confidence in the data used in the risk
estimate. This included an evaluation of the strengths, limitations,
and uncertainties associated with the information used to inform the
risk estimate and the risk characterization. The peer-reviewed PBPK
model used in the 2020 Risk Evaluation allowed EPA to estimate
aggregate exposures from simultaneous dermal, inhalation, and vapor-
through-skin exposures with relatively high confidence.
EPA determined that NMP presents an unreasonable risk of injury to
health. Risks to workers and consumers contribute to the unreasonable
risk from NMP. EPA did not identify risks of injury to the environment
that contribute to the unreasonable risk from NMP. The NMP conditions
of use that EPA evaluated and which contribute to EPA's determination
that the chemical substance poses unreasonable risk to health are
listed in the unreasonable risk determination (Ref. 2) and in Unit
III.B.1.
3. Fenceline Screening Analysis
The 2020 Risk Evaluation for NMP did not fully assess certain
exposure pathways that were or could be regulated under another EPA-
administered statute (see section 1.4.2 of the December 2020 Risk
Evaluation for NMP) (Refs. 1, 2). For NMP, some exposure pathways
received only a screening-level analysis. During problem formulation,
EPA conducted a first-tier screening analysis for the ambient air
pathway to near-field populations downwind from industrial and
commercial facilities releasing NMP, which indicated low risk (83 FR
26998, June 11, 2018) (FRL-9978-40). In the 2020 Risk Evaluation for
NMP, EPA conducted a first-tier analysis to estimate NMP surface water
concentrations and did not identify risks from incidental ingestion or
dermal contact during swimming. This resulted in the ambient air and
drinking water pathways for NMP not being fully assessed in the 2020
Risk Evaluation for NMP. In June 2021, EPA made a policy announcement
on the path forward for TSCA chemical risk evaluations, indicating that
EPA would, among other things, examine whether the exclusion of certain
exposure pathways from the risk evaluations would lead to a failure to
adequately protect fenceline communities (Ref. 3, 21). EPA then
conducted a more robust assessment to identify whether there may be
potential risks to people living near the fenceline of facilities
releasing NMP.
To assess the potential risk to the general population in proximity
to a facility releasing NMP, EPA developed the TSCA Screening Level
Approach for Assessing Ambient Air and Water Exposures to Fenceline
Communities Version 1.0, which was presented to the SACC in March 2022,
with a report issued by the SACC on May 18, 2022 (Ref. 22). This
screening level approach, which EPA believes is effective in accurately
assessing where fenceline
[[Page 51144]]
exposures are of no concern, is discussed in Unit VI.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines, through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or any combination of such activities,
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more of the following requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> 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)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
<bullet> 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)).
<bullet> Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk, so
that NMP no longer presents such unreasonable risk. EPA's proposed
regulatory action and alternative regulatory actions are described in
Unit IV. EPA is requesting public comment on all elements of the
proposed regulatory action and the alternative regulatory actions and
is providing notice that based on consideration of comments and any new
information submitted to EPA during the comment period on this proposed
rule, EPA may in the final rule modify elements of the proposed
regulatory action. The public should understand that public comments
could result in changes to elements of the proposed and alternative
regulatory actions when this proposed rule is finalized. For example,
elements such as timelines could be lengthened or shortened,
concentration limits could be modified, or the WCPP could have
provisions within the WCPP added or eliminated.
Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption from a requirement of a TSCA section 6(a) rule
for a specific condition of use if EPA finds that: (1) The specific
condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; (2) Compliance with the
requirement, as applied with respect to the specific condition of use,
would significantly disrupt the national economy, national security, or
critical infrastructure; or (3) The specific condition of use, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety.
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
TSCA section 6(a) rules, to consider and include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. A
description of all TSCA section 6 requirements considered in developing
this proposed regulatory action is in Unit III.B.3., and Unit V.
includes more information regarding EPA's consideration of
alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether
to prohibit or restrict in a manner that substantially prevents a
specific condition of use and in setting an appropriate transition
period for such action, EPA consider, to the extent practicable,
whether technically and economically feasible alternatives that benefit
health or the environment will be reasonably available as substitutes
when the proposed prohibition or restriction takes effect. Unit V.B.
includes more information regarding EPA's consideration of
alternatives, and Unit VI. provides more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
EPA carried out required consultations as described in this unit
and also considered impacts on children's environmental health as part
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
EPA conducted consultations and outreach in developing this
proposed regulatory action. The Agency held a federalism consultation
from July 22 to October 22, 2021, as part of this rulemaking process
and pursuant to Executive Order 13132. This included a background
presentation on September 9, 2020, and a consultation meeting on July
22, 2021. During the consultation, EPA met with state and local
officials early in the process of developing the proposed action to
receive meaningful and timely input into its development (Ref. 23).
During the consultation, participants and EPA discussed additional
reporting requirements as a risk management tool to address the
unreasonable risk, EPA's consideration of safer alternatives, and
potential impacts to drinking water utilities (Ref. 23).
NMP is not manufactured (including imported) processed distributed
in commerce or regulated by Tribal governments. However, EPA consulted
with Tribal officials during the development of this proposed action
(Ref. 24). The Agency held a Tribal consultation from May 21 to August
27, 2021, with meetings scheduled for June 14 and July 14, 2021. Tribal
officials were given the opportunity to meaningfully interact with EPA
risk managers concerning the current status of risk management. During
the consultation, EPA discussed risk management under TSCA section
6(a), findings from the 2020 Risk Evaluation for NMP, types of
information that would be helpful to inform risk management, principles
for transparency during the risk management process, and types of
information EPA is seeking from Tribes (Ref. 24). EPA received no
written comments as part of this consultation.
[[Page 51145]]
In addition to the formal consultations, EPA also conducted
outreach to advocates of communities that might be subject to
disproportionate risk from the exposures to NMP, such as minority
populations, low-income populations, and indigenous peoples. EPA's
Environmental Justice (EJ) consultation occurred from June 3 through
August 27, 2021. On July 7 and July 13, 2021, EPA held public meetings
as part of this consultation. These meetings were held pursuant to and
in compliance with Executive Orders 12898 and 14008. EPA received one
written comment following the EJ meetings, in addition to oral comments
provided during the consultation (Ref. 25). In general, commenters
supported strong outreach to affected communities, encouraged EPA to
follow the hierarchy of controls used by the industrial hygiene
community, favored prohibitions, and noted the uncertainty, and in some
cases the inadequacy, of PPE. Other commenters asked about the Agency's
schedule for a proposed rule while reconsidering certain aspects of the
2020 Risk Evaluation. Additionally, commenters expressed concern that
the adverse health impacts of NMP, particularly to pregnant women and
children, and urged EPA to ban the use of NMP in paint and coating
removers (Ref. 25). As required by section 609(b) of the Regulatory
Flexibility Act (RFA), EPA convened a Small Business Advocacy Review
(SBAR) Panel to obtain advice and recommendations from small entity
representatives (SERs) that potentially would be subject to this
proposed rule's requirements (Ref. 26). EPA met with SERs before and
during Panel proceedings, on March 28 and May 24, 2023. Panel
recommendations are in Unit X.C. and in the Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 27). The Panel report is in the
docket (Ref. 26). Units X.C., X.E., X.F., and X.J. provide more
information regarding the consultations.
2. Other Stakeholder Engagement
In addition to the formal consultations described in Unit X., EPA
held a webinar on February 24, 2021, providing an overview of the TSCA
risk management process and the risk evaluation findings for NMP. EPA
also presented on the risk evaluation and risk management under TSCA
for NMP at a Small Business Administration Office of Advocacy small
business roundtable on February 26, 2021. At both events, EPA staff
provided an overview of the TSCA risk management process and the
findings in the 2020 Risk Evaluation for NMP (Ref. 28). Attendees of
these meetings were given an opportunity to voice their concerns
regarding the risk evaluation and risk management.
Furthermore, EPA engaged in discussions with representatives from
different industries, non-governmental organizations, technical experts
and users of NMP. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 29); meeting
materials and summaries are also in the docket. The purpose of these
discussions was to create awareness and educate stakeholders and
regulated entities on the provisions for risk management required under
TSCA section 6(a); explain the risk evaluation findings; obtain input
from manufacturers, processors, distributors, users, academics,
advisory councils, and members of the public health community about
uses of NMP; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to NMP under the
conditions of use; understand the importance of NMP in the various uses
subject to this proposed rule; compile knowledge about critical uses,
substitute chemicals or alternative methods; identify various standards
and performance specifications; and generate potential risk reduction
strategies. EPA has met with, or otherwise communicated with, a variety
of companies, trade associations and non-governmental organizations to
discuss the topics outlined in this paragraph; a list of external
meetings held during the development of this proposed rule is in the
docket (Ref. 29).
3. Children's Environmental Health
The EPA 2021 Policy on Children's Health (Ref. 30) requires EPA to
protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
early childhood and through adolescence until 21 years of age) and
lifelong health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk
evaluations ``to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' Infants, children, and
pregnant women are listed as examples of subpopulations that may be
considered relevant ``potentially exposed or susceptible
subpopulations'' in the TSCA section 3(12) definition of that term. In
addition, TSCA section 6(a) requires EPA to apply one or more risk
management requirements under TSCA section 6(a) so that NMP no longer
presents an unreasonable risk (including unreasonable risk to PESS).
The 2020 Risk Evaluation for NMP evaluated risks of NMP to workers and
ONUs, consumers and bystanders, people of reproductive age, pregnant
females and the developing embryo/fetus, infants, children and
adolescents, people with pre-existing conditions, and people with lower
metabolic capacity due to life stage, genetic variation, or impaired
liver function as potentially exposed or susceptible subpopulations who
may be at greater risk than the general population of adverse
developmental health effects from exposure to NMP (Ref. 1). For
exposures to infants and males and females of reproductive age,
evidence was found of reproductive and developmental toxicity. The
reproductive and developmental health effects of concern related to
exposures to NMP are reduced male fertility and female fecundity and
post-implantation loss (resorptions and fetal mortality). While the
literature contains methodological limitations in human studies, animal
studies were considered adequate to represent reproductive and
development effects in the 2020 Risk Evaluation for NMP.
The 2020 Risk Evaluation for NMP considered impacts on both
children and adults from occupational and consumer use from inhalation
and dermal exposures, as applicable. For occupational use, the risk
evaluation considered males (>16 years of age) and females of
reproductive age (>16 years of age to less than 50 years of age) for
both dermal and inhalation exposures. For consumer use, EPA evaluated
oral exposures based on children's exposure potential via mouthing
articles for infants (<1 year), infants (1 to 2 years), and small child
(3 to 5 years), and levels were well below the threshold that could
result in risk. Additionally for consumer use, the risk evaluation
considered dermal and inhalation exposures to females of childbearing
age (16 to 49 years) as the most sensitive subpopulation for other
individuals, adults, and children. (Ref. 1)
B. Regulatory Assessment of NMP
1. Description of Conditions of Use
This unit describes the TSCA conditions of use that EPA proposes to
regulate, including the conditions of use
[[Page 51146]]
that EPA evaluated and considered in making its unreasonable risk
determination for the chemical substance NMP. Condition of use
descriptions were obtained from EPA sources such as CDR use codes, the
2020 Risk Evaluation for NMP and related documents, as well as the
Organisation for Economic Co-operation and Development harmonized use
codes and stakeholder engagements. For clarity and transparency, EPA
has narrowly revised the titles for the NMP conditions of use in this
proposed rulemaking from the 2020 Risk Evaluation for NMP by removing
CDR use code terminology ``not described by other codes'' and ``in
other uses'' (Refs. 31, 32). For additional description of the
conditions of use, including process descriptions and worker activities
considered in the risk evaluation, see the Problem Formulation of the
2020 Risk Evaluation for NMP, the 2020 Risk Evaluation for NMP, and
supplemental files (Refs. 33, 1, 34). EPA acknowledges that some of the
terms in this unit may be defined under other statutes. However, the
descriptions here are intended to provide clarity to the regulated
entities who will implement the provisions of this rulemaking under
TSCA section 6(a).
a. Manufacturing
i. Domestic manufacture. This condition of use refers to the making
or producing of a chemical substance within the United States
(including manufacturing for export), or the extraction of a component
chemical substance from a previously existing chemical substance or a
complex combination of substances.
ii. Import. This condition of use refers to the act of causing a
chemical substance or mixture to arrive within the customs territory of
the United States.
b. Processing
i. Processing as a reactant/intermediate in plastic material and
resin manufacturing and other non-incorporative processing. This
condition of use refers to when a chemical substance is used in
chemical reactions for the manufacturing of another chemical substance
or product. Through processing as a reactant or intermediate, NMP
serves as a feedstock in the production of another chemical product via
a chemical reaction in which NMP is completely consumed. For example,
NMP may be used as a polymerization media to manufacture high-
temperature polymers or other uses as an intermediate, as a media for
synthesis, extractions, and purifications, or as some other type of
processing aid.
ii. Processing, incorporation into formulation, mixture or reaction
products in multiple industrial sectors. This condition of use refers
to the process of mixing or blending several raw materials to obtain a
single product or preparation. NMP may be incorporated into various
formulations, mixtures, or reaction products including, but not limited
to:
<bullet> Adhesives and sealant chemicals in adhesive manufacturing;
<bullet> Anti-adhesive agents in printing and related support
activities;
<bullet> Paint additives and coating additives in paint and coating
manufacturing and print ink manufacturing;
<bullet> Processing aids not otherwise listed in plastic material
and resin manufacturing;
<bullet> 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;
<bullet> Surface active agents in soap, cleaning compound and
toilet preparation manufacturing;
<bullet> Plating agents and surface treating agents in fabricated
metal product manufacturing;
<bullet> 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
<bullet> In oil and gas drilling, extraction and support
activities; plastic material and resin manufacturing; services.
iii. Processing, incorporation into articles in lubricants and
lubricant additives in machinery manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles in lubricants and lubricant additives in machinery
manufacturing, and metal finishing operations conducted as part of
machinery manufacturing. Metal finishing is a broad term used in
industry to include a wide variety of processes that alter the surface
of metal substrates, such as cleaning, coating, etching, and invasive
quality testing.
iv. Processing, incorporation into articles in paint additives and
coating additives in transportation equipment manufacturing. This
condition of use refers to the process or preparation when NMP is
incorporated into articles in paints and coating additives in
transportation equipment manufacturing. Transportation equipment
manufacturing includes motor vehicle parts motor vehicle body and
trailer manufacturing, aerospace product and parts manufacturing,
railroad rolling stock manufacturing, and ship and boat building.
v. Processing, incorporation into articles as a solvent (which
becomes part of a product formulation or mixture) including in
textiles, apparel and leather manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles as a solvent in textiles, apparel and leather manufacturing.
vi. Processing, incorporation into articles in other sectors,
including in plastic product manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles in other sectors, including in plastic product manufacturing.
For example, NMP may be used to produce polymeric resins pellets and
other shapes that are then converted into final plastic articles.
vii. Processing, repackaging. This condition of use refers to the
preparation of a chemical substance or mixture for distribution in
commerce in a different form, state, or quantity. This includes, but is
not limited to, transferring of NMP from a bulk container into smaller
containers.
viii. Processing, recycling. This condition of use refers to
processing waste streams of NMP at third-party site for the purpose of
recovering materials or otherwise preparing the waste for reuse instead
of disposal. Waste solvents can be restored to a condition that permits
reuse via solvent reclamation/recycling. The recovery process may
involve an initial vapor recovery or mechanical separation step
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and commercial use in paints, coatings, and other
adhesive removers. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing products to remove paints,
coatings, and other adhesive removers from various surfaces indoors or
outdoors including, but not
[[Page 51147]]
limited to, graffiti removal from various surfaces.
ii. Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation. This condition of use refers to the
industrial or commercial application of NMP-containing products
including but not limited to paints and coatings, lacquers, stains,
varnishes, primers and floor finishes, and powder coatings in surface
preparation.
iii. Industrial and commercial use in paint additives in computer
and electronic product manufacturing in electronic parts manufacturing.
This condition of use refers to the industrial or commercial use of NMP
or NMP-containing paint additive and coating additive products in
manufacturing and maintaining electrical or electronic parts including
but not limited to magnet wire coating, capacitor, resistor, coil,
transfer and other inductor manufacturing. This description includes,
but is not limited to, use of NMP as an additive in polymeric coatings
used to coat magnet wires, often to give them thermal and solvent
resistance, and in electrical insulating films.
iv. Industrial and commercial use in paint additives and coating
additives in computer and electronic product manufacturing for use in
semiconductor manufacturing. This condition of use refers to the
industrial or commercial use of NMP or NMP-containing paint additive
and coating additive products in manufacturing and maintaining
semiconductor chip manufacturing. This description includes, but is not
limited to, use of NMP as an ingredient for wafer coating and
photoresist activities.
v. Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale and retail trade. This condition of use refers
to the industrial or commercial application of NMP-containing paint
additive and coating additive products including paints, coatings,
adhesives and sealants used in construction, fabricated metal product
manufacturing, machinery manufacturing, other manufacturing, paint and
coating manufacturing, primary metal manufacturing, transportation
equipment manufacturing, wholesale and retail trade.
vi. Industrial and commercial use as a solvent (for cleaning or
degreasing) in electronic equipment, appliance and component
manufacturing. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing solvent (for cleaning or
degreasing) product in manufacturing and maintaining electrical or
electronic parts including, but not limited to magnet wire coating,
capacitor, resistor, coil, transfer and other inductor manufacturing.
This description includes, but is not limited to, use of NMP as a
solvent in enamels, thinners, and cleaners to remove coatings and masks
and in maintenance and equipment cleaning.
vii. Industrial and commercial use as a solvent (for cleaning or
degreasing) in electronic equipment, appliance and component
manufacturing for use in semiconductor manufacturing. This condition of
use refers to the industrial or commercial use of NMP or NMP-containing
containing solvent (for cleaning or degreasing) product in
manufacturing and maintaining semiconductor chip manufacturing. This
description includes, but is not limited to, the use of NMP for
cleaning and stripping wafer surfaces in preparation for other coating
formulations and in maintenance and equipment cleaning activities.
viii. Industrial and commercial use in ink, toner and colorant
products in printer ink and inks in writing equipment. This condition
of use refers to the industrial or commercial use of NMP in printing
and writing activities with products containing NMP. This includes
printing technologies that use inks containing NMP, such as
lithography, flexography, screen, letterpress, and digital
technologies, which includes electrophotography and inkjet printing.
ix. Industrial and commercial use in processing aids, specific to
petroleum production in petrochemical manufacturing, in oil and gas
drilling, extraction and support activities, and in functional fluids
(closed systems). This condition of use refers to the industrial or
commercial use of NMP to improve the processing characteristics or the
operation of process equipment or to alter or buffer the pH of the
substance or mixture, when added to a process or to a substance or
mixture to be processed specific to petroleum production in
petrochemical manufacturing. This includes, but is not limited to, use
as a processing aid for the extraction, separation, and recovery of
aromatic hydrocarbons and other compounds from oils, natural gas, and
refinery gases. Processing agents do not become a part of the reaction
product and are not intended to affect the function of a substance
created.
x. Industrial and commercial use in adhesives and sealants
including binding agents, single component glues and adhesives,
including lubricant adhesives, and two-compound glues and adhesives
including some resins. This condition of use refers to the industrial
or commercial application of NMP-containing adhesive and sealant
products including binding agents, single and two-component glues and
adhesives, lubricant additives, and some resins.
xi. Industrial and commercial use in soldering materials. This
condition of use refers to the industrial or commercial use of NMP in
soldering materials. Soldering is a process in which two or more
substrates, or parts (usually metal), are joined together by melting a
filler metal material (solder or soldering flux) into the joint and
allowing it to cool, thereby joining the independent parts.
xii. Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases. This
condition of use refers to the industrial or commercial use of
automotive servicing products containing NMP in servicing and
maintenance activities in automotive vehicles. Some products may be
applied through aerosol activities, which typically involve the
application of a solution from pressurized cans or bottles that use
propellant to aerosolize the solution, allowing it to be sprayed onto
substrates.
xiii. Industrial and commercial use in metal products not covered
elsewhere, and lubricant and lubricant additives including hydrophilic
coatings. This condition of use refers to the industrial or commercial
use of NMP in products used in metal finishing. Metal finishing is a
broad term used in industry to include a wide variety of processes that
alter the surface of metal substrates, such as cleaning, coating,
etching, and invasive quality testing.
xiv. Industrial and commercial use in laboratory chemicals. This
condition of use refers to the industrial or commercial use of NMP in
laboratory chemicals. This condition of use refers to the industrial
and commercial use of NMP, often in small quantities, in a laboratory
process or in specialized laboratory equipment for instrument
calibration/maintenance chemical analysis, chemical synthesis, as a
carrier chemical, extracting and purifying other chemicals, dissolving
other substances, executing research, development, test
[[Page 51148]]
and evaluation methods, and similar activities.
xv. Industrial and commercial use in lithium ion battery
manufacturing. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing products in manufacturing and
maintaining lithium-ion battery cell manufacturing.
xvi. Industrial and commercial use in cleaning and degreasing, and
cleaning and furniture care products, including wood cleaners and
gasket removers. This condition of use refers to the industrial or
commercial use of NMP in cleaning or degreasing applications,
including, but not limited to, use in industrial facilities and
commercial shops, as well as products that can be used in multiple
applications including, but not limited to, furniture care products,
wood cleaners, and gasket removers. EPA identified NMP-containing
cleaning products used in applications including, but not limited to,
aerosol degreasing, dip/immersion degreasing and cleaning, wipe
cleaning, and spray application.
xvii. Industrial and commercial use in fertilizer and other
agricultural chemical manufacturing, processing aids and solvents. This
condition of use refers to the industrial or commercial use of NMP in
the synthesis of and as a co-solvent in the formulation of agricultural
chemicals. This description includes the use as an NMP containing
fertilizer additive blended into granular or liquid fertilizers.
d. Consumer Uses
EPA determined that the condition of use in Unit III.B.1.d.v
contributes to the unreasonable risk for NMP. As described in this
unit, while EPA determined that seven of the eight consumer uses of NMP
do not contribute to the unreasonable risk, the commercial counterparts
of these conditions of use do contribute to the unreasonable risk. EPA
determined that the seven consumer uses of NMP do not contribute to the
unreasonable risk largely due to the generally low concentration of NMP
in consumer products and the infrequent use by consumers of those
products. (Ref. 1). However, the commercial use of these types of
products does contribute to the unreasonable risk because of their
generally higher concentrations of NMP or frequency of use in a
commercial setting. Therefore, EPA is proposing upstream regulation of
these seven consumer uses to address the unreasonable risk from NMP by
certain commercial uses so that NMP as a whole chemical no longer
presents unreasonable risk, as further discussed in Unit V.A.1.a. The
consumer uses that do not contribute to the unreasonable risk for NMP
are identified in Unit III.B.1.d.i. through iv. and vi. through viii.
Because the potential use of these consumer products by commercial
users contributes to their unreasonable risk, EPA is proposing upstream
regulation of these consumer conditions of use as described in Unit
IV.A.2.
i. Consumer use in paint and coating removers. This condition of
use refers to consumer use of NMP-containing products in paint and
coating remover products.
ii. Consumer use in adhesive removers. This condition of use refers
to consumer use of NMP-containing products in adhesive remover
products.
iii. Consumer use in paints and coatings in lacquers, stains,
varnishes, primers and floor finishes. This condition of use refers to
consumer use of NMP-containing products in paints and coatings products
including lacquers, stains, varnishes, primers and floor finishes.
iv. Consumer use in paint additives and coating additives in paints
and arts and crafts paints. This condition of use refers to consumer
use of NMP-containing products in paint additive and coating additive
products including paints and arts and crafts paints.
v. Consumer use in adhesives and sealants in glues and adhesives,
including lubricant adhesives. This condition of use refers to consumer
use of NMP-containing products in adhesive and sealant products.
vi. Consumer use in automotive care products. This condition of use
refers to consumer use of NMP-containing products in automotive care
products. This description includes automotive interior cleaning
products.
vii. Consumer use in cleaning and furniture care products,
including wood cleaners and gasket removers. This condition of use
refers to consumer use of NMP-containing products in cleaning and
furniture care products, including wood cleaners and gasket removers.
This description includes cleaners and degreasers and engine cleaners
and degreasers.
viii. Consumer use in lubricant and lubricant additives, including
hydrophilic coatings. This condition of use refers to consumer use of
NMP-containing products in lubricant and lubricant additive products.
e. Disposal
This condition of use refers to the process of disposing generated
waste streams of NMP that are collected either on-site or collected and
transported to a third-party site, such as waste incineration sites,
for disposal.
f. Terminology in This Proposed Rule
For purposes of this proposed rulemaking ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for NMP for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority over ``any manner or method of
commercial use'' under TSCA section 6(a)(5) to reach both.
Additionally, in the 2020 Risk Evaluation for the chemical
substance NMP, EPA identified and assessed all known, intended, and
reasonably foreseen processing, industrial, commercial, and consumer
uses of NMP in order to determine whether NMP as a whole chemical
substance presents unreasonable risks to health and the environment.
EPA determined that all processing, industrial, and commercial uses of
NMP evaluated in the 2020 Risk Evaluation for NMP contribute to the EPA
determination that NMP presents unreasonable risk of injury to health.
As such, for purposes of this risk management rulemaking,
``processing'' refers to all processing, including known, intended, and
reasonably foreseen processing of NMP. Likewise, for the purpose of
this risk management rulemaking, ``industrial and commercial use''
refers to all industrial and commercial uses, including known,
intended, or reasonably foreseen NMP industrial and commercial use.
EPA is not proposing to incorporate the descriptions in Unit
III.B.1.a. through e. into the regulatory text as definitions. EPA
requests comment on whether EPA should promulgate definitions for those
conditions of use evaluated in the 2020 Risk Evaluation for NMP that
would not be prohibited, and, if so, whether the descriptions in this
unit are consistent with the conditions of use evaluated in the 2020
Risk Evaluation for NMP and whether they provide a sufficient level of
detail to improve the clarity and readability of the regulation. EPA
further notes that this proposed rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(ii) through (vi). Those exclusions include, but are not
limited to, any pesticide (as defined by the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide; and any food, food
additive, drug, cosmetic, or device,
[[Page 51149]]
as defined in the Federal Food, Drug, and Cosmetic Act (FFDCA) section
201, when manufactured, processed, or distributed in commerce for use
as a food, food additive, drug, cosmetic or device. For example, the
proposed rule does not apply to NMP used as a nail polish remover,
provided it is manufactured, processed, or distributed in commerce for
such use, because nail polish remover is a cosmetic as defined in FFDCA
section 201(i).
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that NMP presents an unreasonable risk of injury
to human health under the conditions of use based on acute and chronic
non-cancer risks. As described in the TSCA section 6(b) 2020 Risk
Evaluation for NMP, EPA identified non-cancer adverse effects from
acute and chronic inhalation and dermal exposures to NMP. EPA
identified that the best representative endpoints for non-cancer
effects were from acute (developmental toxicity) and chronic
(reproductive toxicity) inhalation and dermal exposures for all
conditions of use. Additional risks associated with other adverse
effects (e.g., liver toxicity, kidney toxicity, immunotoxicity,
neurotoxicity, irritation and sensitization) were identified for acute
and chronic inhalation and dermal exposures. EPA did not evaluate
cancer risk from exposure to NMP because NMP is not mutagenic and is
not considered carcinogenic. Unit VI.A. summarizes the health effects
and the magnitude of exposures (Ref. 1).
The 2020 Risk Evaluation for NMP assessed exposure from inhalation,
dermal, and vapor through skin exposure, and identified that the
unreasonable risk of injury to human health is mainly driven by direct
dermal contact with NMP. Therefore, EPA is proposing dermal exposure
controls (or, as needed, prohibitions) to prevent direct dermal contact
with NMP. While inhalation risks contribute to the unreasonable risk
from NMP, addressing inhalation risks alone would not mitigate the
unreasonable risk from NMP. For a small number of conditions of use
where inhalation and dermal exposures both significantly contribute to
the unreasonable risk, EPA is proposing inhalation and dermal exposure
controls. The measures to address the unreasonable risk are discussed
further in Unit IV., and the rationale for these measures are discussed
further in Unit V.
To make the unreasonable risk determination for NMP, EPA evaluated
exposures to workers, ONUs, consumer users, and bystanders to consumer
use using reasonably available monitoring and modeling data for
inhalation and dermal exposures. EPA conducted a screening-level
analysis to assess potential risks from the air and water pathways to
fenceline communities. A discussion of EPA's analysis and the expected
effects of this rulemaking on fenceline communities is in Unit VI.A.
For the 2020 Risk Evaluation for NMP, EPA considered PESS. EPA
identified the following groups as PESS: workers, ONUs, consumers,
bystanders, males and females of reproductive age, pregnant women and
the developing embryo/fetus, infants, children, and adolescents, people
with pre-existing conditions and people with lower metabolic capacity
due to life stage, genetic variation, or impaired liver function (Ref.
1). All PESS are included in the quantitative and qualitative analyses
described in the risk evaluation, and were considered in the
determination of unreasonable risk for NMP. As discussed in Unit II.D.
and Unit VI.A., the 2020 Risk Evaluation for NMP did not fully assess
some exposure pathways, including the air and surface water exposure
pathways to the general population from the published risk evaluations
and may have caused some risks to be unaccounted for in the risk
evaluation. EPA considers these communities a subset of the general
population and categorizes them as fenceline communities; they may also
be considered PESS. See Unit VI.A. for further discussion on assessing
and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to address the
unreasonable risk for NMP.
As required, EPA developed a proposed regulatory action and an
alternative regulatory action, which are described in Units IV.A. and
IV.B., respectively. To identify and select a regulatory action, EPA
considered the two routes of exposure driving the unreasonable risk,
inhalation and dermal, and the exposed populations. For occupational
conditions of use (see Unit III.B.1.f.), EPA considered how it could
directly regulate manufacturing (including import), processing,
distribution in commerce, industrial and commercial use, or disposal to
address the unreasonable risk. EPA does not have direct authority to
regulate consumer use. Therefore, EPA considered how it could exercise
its authority under TSCA to regulate the manufacturing (including
import), processing, and/or distribution in commerce of NMP at
different points in the supply chain to eliminate exposures or restrict
the availability of NMP and NMP-containing products for consumer use to
address the unreasonable risk.
As required by TSCA Section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions: (i) The effects of NMP on
health and the environment, (ii) The magnitude of exposure to NMP of
human beings and the environment, (iii) The benefits of NMP for various
uses, and (iv) The reasonably ascertainable economic consequences of
the rule. In evaluating the reasonably ascertainable economic
consequences of the rule, EPA considered: (i) The likely effect of the
rule on the national economy, small business, technological innovation,
the environment, and public health; (ii) The costs and benefits of the
proposed regulatory action and alternative regulatory action
considered; and (iii) The cost effectiveness of the proposed regulatory
action and of the alternative regulatory action considered. See Unit
VI. for further discussion related to TSCA section 6(c)(2)(A)
considerations, including the statement of effects of the proposed rule
with respect to these considerations.
EPA also considered the regulatory authority under TSCA and other
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and
other EPA-administered statutes to examine: (1) Whether there are
opportunities for all or part of risk management action on NMP to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a)
regulation could include alignment of requirements and definitions in
and under existing statutes to minimize confusion to the regulated
entities and the general public.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit IV.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory actions in Unit IV.).
To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy
[[Page 51150]]
of controls adopted by OSHA and NIOSH, with the goal of identifying
risk management control methods that are permanent, feasible, and
effective. EPA also considered how to address the unreasonable risk
while providing flexibility to the regulated entities where
appropriate. EPA considered the information presented in the 2020 Risk
Evaluation for NMP, as well as additional input from stakeholders (as
described in Unit III.A.), and anticipated compliance strategies from
regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and alternative regulatory action described in Unit
IV. Additional details related to how the requirements in this unit
were incorporated into development of those actions are in Unit V.
IV. Proposed and Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
NMP will no longer present an unreasonable risk of injury to health. In
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost-effectiveness of the proposed
regulatory action and alternative regulatory action. In the case of
NMP, the proposed regulatory action is described in Unit IV.A. and the
alternative regulatory action considered is described in Unit IV.B. An
overview of the proposed regulatory action and alternative regulatory
action for each condition of use is in Unit IV.C. The rationale for the
proposed and alternative regulatory action and associated compliance
timeframes are discussed in this unit and in more detail in Unit V.A.
Discussion of the consideration of TSCA section 6(c)(2)(A) is further
described in Unit VI.
A. Proposed Regulatory Action
EPA is proposing, under TSCA section 6(a) to: Prohibit the
manufacture (including import), processing, distribution in commerce,
and industrial and commercial use of NMP for five occupational uses;
Require container size limits and labeling requirements for the
manufacture (including import), processing, and distribution in
commerce of NMP products for seven consumer uses; Require prescriptive
controls, including concentration limits and PPE, for seven
occupational conditions of use; Require strict workplace controls,
including an NMP WCPP, which would include requirements to prevent
direct dermal contact with NMP, for all other occupational conditions
of use; Require a concentration limit on NMP for the import,
processing, and distribution in commerce for one consumer use; and
Establish recordkeeping and downstream notification requirements.
Pursuant to TSCA section 12(a)(2), this proposed rule would apply to
NMP even if being manufactured, processed, or distributed in commerce
solely for export from the United States because EPA has determined
that NMP presents an unreasonable risk to health or the environment
within the United States.
To aid the regulated community with implementing the prohibitions
and restrictions, and to account for de minimis levels of NMP as an
impurity in products, EPA is proposing that products containing NMP at
concentrations less than 0.1% by weight would not be subject to the
prohibitions and restrictions described in this unit. EPA has
determined that the prohibitions and restrictions would only be
necessary for products containing NMP at levels equal to or greater
than 0.1% by weight to eliminate the unreasonable risk of injury
resulting from inhalation and dermal exposures from NMP-containing
products during occupational and consumer conditions of use. EPA's
description for how allowing for a concentration of NMP up to 0.1%
would not hinder the ability of this rulemaking to address the
unreasonable risk associated with NMP-containing products and rationale
for this regulatory approach are in Unit V.A. EPA requests comment on
allowing this de minimis level of NMP in products to account for
impurities.
1. Prohibition of Certain Occupational Uses and Manufacturing,
Processing, and Distribution in Commerce of NMP for Those Uses
EPA is proposing to prohibit the manufacturing (including import),
processing, distribution in commerce, and use of NMP for the following
conditions of use:
<bullet> Processing incorporation into articles in lubricants and
lubricant additives in machinery manufacturing;
<bullet> Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases;
<bullet> Industrial and commercial use in metal products not
covered elsewhere and lubricant and lubricant additives including
hydrophilic coatings;
<bullet> Industrial and commercial use in cleaning and degreasing
and cleaning and furniture care products, including wood cleaners and
gasket removers; and
<bullet> Industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents.
The industrial and commercial uses of NMP in specialized
electronics, such as lithium ion battery manufacturing for use in
electronic vehicles or semiconductor manufacturing, and the associated
upstream manufacturing (including import) and processing uses are not
prohibited. EPA supports the continuation of these specialized
electronic uses while addressing the unreasonable risk through
appropriate exposure controls, detailed in Unit IV.A.3.
As discussed in Units III.B.3. and V.A., based on the Agency's
consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty relative to the feasibility of exposure reduction to
sufficiently address the unreasonable risk across the broad range of
work environments and activities, and the irreversible health effects
associated with NMP exposures, EPA has determined that prohibition of
the conditions of use identified in this unit is the best way to
address the unreasonable risk from NMP. EPA believes there are a
sufficient number of alternatives for these uses, described further in
Unit V.B. and the Alternatives Assessment (Ref. 4).
EPA is proposing that the prohibitions on manufacturing (including
import), processing, distribution in commerce, and industrial and
commercial use of NMP for these conditions of use would follow a
staggered schedule, due to supply chain considerations. EPA proposes
that the compliance dates for the proposed prohibitions described in
this unit would come into effect in 12 months for manufacturers, 15
months for processers, 18 months for distributing to retailers, 21
months for all other distributors (including retailers), and 24 months
for industrial and commercial users after the publication date of the
final rule. When proposing these compliance dates as required under
TSCA section 6(d), EPA considered irreversible health effects and risks
associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
For NMP, for the conditions of use EPA is proposing to prohibit, the
Agency believes either NMP may no longer be used or regulated entities
would be able to meet the proposed or alternative compliance timeframes
due to availability of alternatives. EPA recognizes that for other
proposed regulations under TSCA
[[Page 51151]]
section 6, including methylene chloride (88 FR 28284, May 3, 20230
(FRL-8155-02-OCSPP), perchloroethylene (88 FR 39652, June 16, 2023)
(FRL-8329-02-OCSPP), and carbon tetrachloride (88 FR 49180, July 28,
2023) (RL-8206-01-OCSPP), public comments have provided information in
support of longer compliance timeframes. Similarly, for NMP, EPA
requests comment on whether additional time is needed, for example, for
products to clear the channels of trade, or for implementing the use of
substitutes. Comments should include documentation such as the specific
use of the chemical throughout the supply chain; concrete steps taken
to identify, test, and qualify substitutes for those uses (including
details on the substitutes tested and the specific certifications that
would require updating); and estimates of the time required to
identify, test, and qualify substitutes with supporting documentation.
EPA also requests comment on whether these are the appropriate types of
information for use in evaluating compliance requirements, and whether
there are other considerations that should apply. EPA may finalize
significantly shorter or longer compliance timeframes based on
consideration of public comments. EPA is also requesting comment on:
(1) whether respiratory protection and dermal PPE should be required
before the effective date of the prohibition; (2) to what extent
inhalation and dermal PPE may already be implemented in most uses being
prohibited; and (3) whether requirements that inhalation and dermal PPE
be used before the effective dates of prohibitions would be overly
burdensome to entities indicated in this unit that would be working to
comply with the prohibition. EPA is requesting comments from the public
for more information about the uses EPA is proposing to prohibit,
particularly the industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents, and
the ability for workplaces in these conditions of use to comply with
strict workplace controls like those required under the WCPP, or the
ability to comply with a prohibition and reformulate to an alternative
chemical or process.
Additionally, EPA recognizes that there may be instances where an
ongoing use of NMP that has implications for national security or
critical infrastructure as it relates to other Federal agencies (e.g.,
DOD, DOE, NASA) is identified after the NMP rule is finalized, but the
final rule prohibits that use. For instances like that, EPA requests
comments on an appropriate, predictable process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued using the tools
available under TSCA, aligning with the requirements of TSCA section
6(g). One example of an approach could be the establishment by
rulemaking of a Federal agency category of use that would require
implementation of the WCPP and periodic reporting to EPA on details of
the use as well as progress in discontinuing the use or finding a
suitable alternative. To utilize the category of use a Federal agency
would petition EPA, supported by documentation describing the specific
use (including documentation of the specific need, service life of any
relevant equipment, and specific identification of any applicable
regulatory requirements or certifications, as well as the location and
quantity of the chemical being used); the implications of cessation of
this use for national security or critical infrastructure (including
how the specific use would prevent injuries/fatalities or otherwise
provide life-supporting functions); exposure control plan; and, for
Federal agency uses where similar adoption by the commercial sector may
be likely, concrete steps taken to identify, test, and qualify
substitutes for the uses (including details on the substitutes tested
and the specific certifications that would require updating; and
estimates of the time required to identify, test, and qualify
substitutes with supporting documentation). In the event that sensitive
information relating to national security or critical infrastructure
would be submitted to EPA, EPA would protect the submitted information
in accordance with applicable authorities. EPA requests comment on
whether these are the appropriate types of information for use in
evaluating this type of category of use, and whether there are other
considerations that should apply. EPA would make a decision on the
petition within 30 days and publish the decision in the Federal
Register shortly after. Additionally, during the year following the
petition, EPA would take public comment on the approved petition and no
later than 180 days after submitting the petition to EPA, the
requesting agency would submit monitoring data indicating compliance
with the WCPP at each relevant location as well as documentation of
efforts to identify or qualify substitutes. In the absence of that
confirmatory data, the utilization of the generic Federal agency
category of use would expire within one year of the date of receipt by
EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking
for those instances where the Federal agency could not demonstrate
compliance with the WCPP. This is just one example of a potential
process. EPA requests comments on a process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued.
EPA continues to work with Federal agency partners to develop a
regulatory approach to accommodate uses needed for national security or
critical infrastructure purposes in a manner that complies with EPA
requirements for implementation of a workplace chemical protection plan
(WCPP) and any other EPA identified protective measures intended to
mitigate an unreasonable risk of injury to health or the environment.
EPA solicits comment on all aspects of its steps to accommodate these
uses in this proposed rule and whether any additional measures are
needed.
2. Container Size Restrictions and Labeling Requirements
EPA has identified consumer products similar to the commercial
products proposed to be prohibited. While EPA determined that the
consumer uses of NMP listed in this unit do not contribute to the
unreasonable risk, EPA found that the commercial counterparts of these
conditions of use do contribute to the unreasonable risk due to the
increased exposure from more frequent use. As described in Unit
III.B.3., under TSCA section 6(a), EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. As such, EPA is proposing tailored upstream regulations for
these consumer conditions of use to manage the exposures to similar
commercial conditions of use. In this way, NMP would not present
unreasonable risk to workers. These restrictions are intended to
prevent the consumer products intended for consumer use from being
unlawfully used in commercial activities. EPA is proposing to prohibit
the import, processing, and distribution in commerce of NMP or NMP-
containing products for these consumer uses of NMP if the containers
exceed a
[[Page 51152]]
volume more than 16 ounces. The rationale for this container size
volume is described in Unit V.A.1.b.
EPA is proposing to restrict the container size and require labels
for NMP-containing products for the following consumer uses:
<bullet> In paint and coating removers;
<bullet> In adhesive removers;
<bullet> In paints and coatings in lacquer, stains, varnishes,
primers and floor finishes;
<bullet> In paint additives and coating additives in paints and
arts and crafts paints;
<bullet> In automotive care products;
<bullet> In cleaning and furniture care products, including wood
cleaners, gasket removers; and
<bullet> 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:
<bullet> Manufacturing (domestic manufacturing);
<bullet> Manufacturing (import);
<bullet> 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;
<bullet> 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
<bullet> Disposal.
As described in Unit III.B.3., EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. The TSCA section 6(a) requirements provide EPA the authority
to limit or restrict a number of activities, alone or in combination,
including the manufacture, processing, distribution in commerce,
commercial use, and disposal of the chemical substance. Given this
authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational (e.g.,
manufacturing, processing, industrial and commercial use, and disposal)
conditions of use. The WCPP for NMP would encompass DDCC requirements,
and the associated implementation requirements described in this unit
to ensure that the chemical substance no longer presents unreasonable
risk.
Under a WCPP, owners or operators would have some flexibility,
within the parameters outlined in this unit, regarding how they prevent
direct dermal contact. In the case of NMP,
[[Page 51153]]
implementing the DDCC requirements for certain occupational conditions
of use would address unreasonable risk to potentially exposed persons
from dermal exposure.
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where NMP is present and who may be exposed to NMP under
the conditions of use for which a WCPP would apply. One important
reason to define a potentially exposed person for the purposes of a
WCPP as any person who may be exposed in the workplace is to emphasize
the broad scope of exposures which must be categorized when
implementing a WCPP. EPA notes that this definition is intended to
apply only in the context of risk management, and specifically in the
context of a WCPP (e.g., workers directly using the chemical, workers
in the vicinity of the use, students in a laboratory setting). The term
is not intended as a replacement for the term Potentially Exposed or
Susceptible Subpopulation as defined by TSCA section 3(12). EPA
additionally recognizes that other individuals or communities may be
exposed to NMP as consumers, members of fenceline communities, or
members of the general population, which is separate and apart from
those potentially exposed for the purposes of the regulatory
requirements of the WCPP. In those instances, where regulatory
requirements address exposures unrelated to a WCPP EPA would use
distinct terminology to refer to those other populations. EPA's
intention is to require a comprehensive WCPP that would address the
unreasonable risks from NMP to potentially exposed persons directly
handling the chemical or in the area where the chemical is being used.
Similarly, the 2020 risk evaluation for NMP did not distinguish
between employers, contractors, or other legal entities or businesses
that manufacture, process, distribute in commerce, use, or dispose of
NMP.
EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use is occurring and NMP is present. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace.
DDCC requirements are process-based approaches to prevent direct
dermal contact with NMP and associated implementation requirements
described in this unit to ensure that the chemical substance no longer
presents unreasonable risk from dermal exposure. DDCC requirements
allow regulated entities some flexibility within certain parameters
outlined in this unit for preventing direct dermal contact with NMP. In
the case of NMP, EPA has preliminarily determined that preventing
direct dermal contact through DDCC requirements for certain conditions
of use would address their contribution to the unreasonable risk from
NMP. NMP is slightly volatile, and preventing direct dermal contact
with NMP would also inherently reduce inhalation exposure by reducing
concentration of NMP in air from volatilization, further preventing
unreasonable risk to workers.
This unit includes a summary of the proposed NMP WCPP, including a
description of the proposed DDCC requirements and associated
implementation requirements; consideration of the NIOSH hierarchy of
controls (hereafter referred to as ``hierarchy of controls''); and
additional requirements proposed for recordkeeping, workplace training,
workplace participation, and notification. This unit also describes
compliance timeframes for these proposed requirements.
b. Direct Dermal Contact Control (DDCC) Requirements
i. Direct dermal contact. DDCC requirements are a process-based set
of provisions to address unreasonable risk driven by dermal exposure by
preventing direct dermal contact in the workplace. To address the
unreasonable risk driven by dermal exposure to NMP, DDCC requirements
would include controls to separate, distance, physically remove, or
isolate all person(s) from direct handling of NMP or from skin contact
with surfaces that may be contaminated with NMP (i.e., equipment or
materials on which NMP may be present) under routine conditions in the
workplace (hereafter referred to as direct dermal contact). The 2020
Risk Evaluation for NMP assessed risks to workers from inhalation and
dermal exposure, and concluded the risk was driven by the dermal
exposure, mainly direct skin contact with NMP. Risk exceeding the
benchmark was identified even when considering use of chemically
resistant gloves in most commercial and industrial conditions of use.
The 2020 Risk Evaluation deduced that direct dermal contact drives the
unreasonable risk by comparing the internal exposure to workers with
inhalation, vapor through skin and dermal liquid contact with internal
exposure to ONUs due to inhalation and vapor through skin exposure (a
subtraction technique). The percent exposure to NMP due to dermal
contact with liquid is provided in table 4-54 in section 4.3.7 of the
2020 Risk Evaluation (Ref. 1). EPA's description for how the
requirements related to DDCC would address the unreasonable risk
resulting from dermal exposures and the rationale for this regulatory
approach is outlined in Units III.B.3. and V.A.
As part of DDCC requirements, EPA is proposing to require owners
and operators to implement dermal exposure controls in accordance with
the hierarchy of controls. EPA also recommends and encourages the use
of pollution prevention as a means of controlling exposures whenever
practicable. EPA is also proposing to align DDCC requirements with the
implementation of several OSHA standards, including the hazard
communication (29 CFR 1910.1200) and general PPE requirements standards
(29 CFR 1910.132), recognizing that OSHA has not set an exposure limit
for inhalation or direct dermal exposure for NMP.
Within certain parameters outlined in this unit, DDCC requirements
are non-prescriptive, in the sense that it does not require a specific
control to prevent direct dermal contact. Rather, it would enable
regulated entities to determine how to most effectively prevent direct
dermal contact based on what works best for their workplace, in
accordance with the hierarchy of controls. Each owner or operator of a
workplace engaging in a condition of use for which DDCC requirements
are proposed would be responsible for compliance with the DDCC
requirements and recordkeeping.
As discussed briefly in Unit IV.A.1. and further in Unit V.A.1.,
EPA expects that many workplaces already have stringent controls in
place that reduce dermal exposures to NMP; for some workplaces, EPA
understands that these existing controls may already prevent or reduce
direct dermal contact with NMP to the extent necessary to address the
unreasonable risk.
ii. Incorporation of the hierarchy of controls. EPA is proposing to
require owners or operators to implement DDCC requirements in
accordance with the hierarchy of controls and encourages the use of
pollution prevention to control exposures whenever practicable. EPA
recognizes that some owners or operators may have industrial hygiene
practices already preventing direct dermal contact with NMP in the
workplace. For example, the semiconductor sector has provided EPA
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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
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impervious for the expected duration and conditions of exposure by
reporting cumulative permeation rate as a function of time (e.g., by
using the suggested format presented in ASTM F1194, ``Standard Guide
for Documenting the Results of Chemical Permeation Testing of Materials
Used in Protective Clothing,'' or equivalent manufacturer- or supplier-
provided testing). Owners and operators would also be required to
consider likely combinations of chemical substances to which the
clothing may be exposed in the work area when selecting the appropriate
PPE such that the PPE will prevent direct dermal contact to NMP. EPA is
proposing that PPE must be immediately provided and replaced if any
person is dermally exposed to NMP longer than the breakthrough time
period for which testing has demonstrated that the PPE will be
impermeable or if there is a chemical permeation or breakage of the
PPE.
Also consistent with 29 CFR 1910.132, owners and operators would be
required to provide any person in the workplace with PPE and provide
training on proper use (e.g., when and where PPE is necessary, proper
application, wear, and removal of PPE, and maintenance, useful life and
disposal of PPE) where the potential for direct dermal contact with NMP
may exist. Owners and operators would also have to re-train any
affected persons potentially exposed to direct dermal contact with NMP
whenever the owner or operator has reason to believe that a previously
trained person does not have the required understanding and skill to
properly use PPE or when changes in the workplace, or in the PPE to be
used, render the previous training obsolete.
Additionally, EPA is proposing to require that owners and operators
subject to this rulemaking comply with provisions of 29 CFR 1910.133(b)
for requirements on selection and use of eye and face protection.
Similarly, EPA is proposing to require that owners and operators
subject to this rulemaking who would be required to administer a
respiratory protection program do so with worksite-specific procedures
and elements for required respirator use in accordance with 29 CFR
1910.134(a) through (l), except 29 CFR 1910.134(d)(1)(iii) and
(d)(3)(i)(B), for proper respirator use, maintenance, fit-testing,
medical evaluation, and training. While EPA does not propose that the
WCPP for NMP proposed for the conditions of use listed earlier in this
unit include respiratory protection requirements, EPA notes that the
proposed prescriptive controls for conditions of use listed in Unit
IV.A.4. would include respiratory protection. For respiratory PPE, EPA
is proposing that the owner or operator must ensure that all cartridges
and canisters used in the workplace are labeled and color coded with
the NIOSH approval label and that the label is not removed and remains
legible. 29 CFR 1910.134(d)(3)(iii), which EPA is proposing to cross-
reference, requires either the use of respirators with an end-of-life
service indicator certified by NIOSH for the contaminant, in this case
NMP, or implementation of a change schedule for canisters and
cartridges that ensures that they are changed before the end of their
service life. EPA is requesting comment on whether there should be a
requirement to replace cartridges or canisters after a certain number
of hours, such as the requirements found in OSHA's General Industry
Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a requirement for
a minimum service life of non-powered air-purifying respirators such as
the requirements found in OSHA's General Industry Standard for Benzene
(29 CFR 1910.1028(g)(3)(D)). Further information related to choosing
appropriate respirators, including specific examples of respirator
types, can be found in appendix F of the 2020 Risk Evaluation for NMP
(Ref. 1).
EPA proposes to require that owners and operators document in the
exposure control plan, or other documentation of the facility's safety
and health program, information relevant to respiratory program,
including records on the name, workplace address, work shift, job
classification, work area, and type of respirator worn (if any) by each
potentially exposed person, maintenance, and fit-testing, as described
in 29 CFR 1910.134(f), and training in accordance with 29 CFR
1910.132(f) and 29 CFR 1910.134(k).
EPA is soliciting comments on the non-prescriptive proposed DDCC
requirements for appropriate PPE selection, the effectiveness of PPE in
preventing direct dermal contact with NMP in the workplace. EPA
requests information on other potential dermal performance standards,
and on general absorption and permeation effects to PPE as a result of
direct contact.
In addition, EPA understands that some workplaces rinse and reuse
PPE after minimal use and is therefore soliciting comments on the
impact on effectiveness of rinsing and reusing certain types of PPE,
either gloves or protective clothing and gear. EPA also requests
comment on the degree to which additional guidance related to use of
PPE might be appropriate, including specifying PPE type or additional
standard testing specifications.
EPA is also proposing that owners and operators retain records of
the PPE that is used and program implementation. EPA proposes to
require that owners and operators document in the exposure control
plan, or other documentation of the facility's safety and health
program, information relevant to any PPE program, as applicable,
including: (A) the name, workplace address, work shift, job
classification, and work area of each person reasonably likely to
directly handle NMP or handle equipment or materials on which NMP may
present and the type of PPE selected to be worn by each of these
persons; (B) the basis for specific PPE selection (e.g., demonstration
based on permeation testing or manufacturer specifications that each
item of PPE selected provides an impervious barrier to prevent exposure
during expected duration and conditions of exposure, including the
likely combinations of chemical substances to which the PPE may be
exposed in the work area); (C) appropriately sized PPE and training on
proper application, wear, and removal of PPE, and proper care/disposal
of PPE; (D) occurrence and duration of any direct dermal contact with
NMP that occurs during any activity or malfunction at the workplace
that causes direct dermal exposures to occur and/or glove breakthrough,
and corrective actions to be taken during and immediately following
that activity or malfunction to prevent direct dermal contact to NMP;
and (E) training in accordance with 29 CFR 1910.132(f), including any
re-training. EPA may require more, less, or different documentation in
the final rule based on consideration of public comments.
d. General WCPP Requirements
i. Exposure control plan. EPA proposes to require that owners and
operators document their exposure control strategy and implementation
in an exposure control plan or through adding EPA-required information
to any existing documentation of the facility's safety and health
program developed as part of meeting OSHA requirements or other safety
and health standards. EPA proposes to require that each owner or
operator document in the exposure control plan the following:
(A) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of NMP, substitution of
NMP, engineering controls, and administrative controls to prevent or
reduce direct dermal contact with NMP in the workplace;
[[Page 51156]]
(B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(D) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(E) Description of any restricted area and how it is demarcated,
and identification of authorized persons; and description of when the
owner or operator expects potential direct dermal contact exposures;
(F) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(G) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes direct dermal contact with NMP
and subsequent corrective actions taken during start-up, shutdown, or
malfunctions to mitigate exposures to NMP; and
(H) Availability of the exposure control plan and associated
records for potentially exposed persons.
ii. Workplace information and training. EPA is also proposing to
require implementation of a training program in alignment with the OSHA
Hazard Communication Standard (29 CFR 1910.1200). To ensure that
potentially exposed persons in the workplace are informed of the
hazards associated with NMP exposure, EPA is proposing to require that
owners or operators of workplaces subject to the WCPP institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program. As
part of the training and information program, the owner or operator
would be required to provide information and comprehensive training in
an understandable manner (i.e., plain language), considering factors
such as the skills required to perform the work activity and the
existing skill level of the staff performing the work, and in multiple
languages as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons. This
information and training would have to be provided prior to or at the
time of initial assignment to a job involving potential exposure to
NMP. In alignment with the OSHA Hazard Communication Standard, owners
and operators would be required to provide information and training to
all potentially exposed persons that includes (A) the requirements of
the NMP WCPP and how to access or obtain a copy of the requirements of
the WCPP; (B) the quantity, location, manner of use, release, and
storage of NMP and the specific operations in the workplace that could
result in NMP exposure; (C) principles of safe use and handling of NMP
in the workplace, including specific measures the owner or operator has
implemented to prevent direct dermal contact with NMP, such as work
practices and PPE used; (D) the methods and observations that may be
used to detect the presence or release of NMP in the workplace (such as
visual appearance or odor of NMP when being released, etc.); and (E)
the health hazards associated with exposure with NMP. In addition to
providing training at the time of initial assignment to a job involving
potential exposure to NMP, and in alignment with the OSHA General
Industry Standard for Beryllium (20 CFR 1910.1024), which includes an
annual retraining provision, owners and operators subject to the NMP
WCPP would be required to re-train each potentially exposed person
annually to ensure they understand the principles of safe use and
handling of NMP in the workplace. Owners and operators would also need
to update the training as necessary whenever there are changes in the
workplace, such as new tasks or modifications of tasks; in particular,
whenever there are changes in the workplace that increase exposure to
NMP or where potentially exposed persons' direct dermal contact
exposure to NMP can reasonably be expected to occur. In alignment with
the OSHA General Industry Standard for Methylene Chloride (29 CFR
1910.1052) owners and operators would need to retrain any exposed
person if exposure to direct dermal contact of NMP, including vapor
through skin exposure, occurs. To support compliance, EPA is proposing
that each owner or operator of a workplace subject to the WCPP would be
required to provide to the EPA, upon request, all available materials
related to workplace information and training.
iii. Workplace participation. EPA encourages owners or operators to
consult with potentially exposed persons on the development and
implementation of exposure control plans and PPE. EPA is proposing to
require owners or operators to provide potentially exposed persons, or
their designated representatives, regular access to the exposure
control plans and PPE program implementation and documentation. To
ensure compliance in workplace participation, EPA is proposing that the
owner or operator document the notice to and ability of any potentially
exposed person to NMP direct dermal contact to readily access the
exposure control plans, PPE program implementation, or any other
information relevant to NMP exposure in the workplace. EPA is
requesting comment on how owners and operators can engage with
potentially exposed persons on the development and implementation of an
exposure control plan and PPE program.
iv. Recordkeeping. To support and demonstrate compliance, EPA is
proposing that each owner or operator of a workplace subject to WCPP
retain compliance records for five years. EPA is proposing to require
records to include:
(A) the exposure control plan;
(B) PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
(C) information and training provided to each person prior to or at
the time of initial assignment and any re-training.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA for examination and copying. All records required to
be maintained by this unit could be kept in the most administratively
convenient form (electronic or paper).
v. Compliance timeframes. With regard to the compliance timeframe
for those occupational conditions of use that are subject to WCPP
requirements, EPA is proposing to require that each owner or operator
of a workplace subject to WCPP establish the process outlined in this
unit within 12 months of publication of the final rule in the Federal
Register for the private sector, and within 36 months of publication of
the final rule in the Federal Register for Federal agencies and Federal
contractors acting for or on behalf of the Federal government. For the
private sector, EPA has no reasonably available information indicating
this proposed compliance date of 12 months is not practicable for WCPP
requirements, or that additional time is needed. However, EPA is
concerned about the ability of certain departments and agencies of the
Federal Government, as well as Federal contractors acting for or on
behalf of the Federal Government, to comply with these timeframes. The
importance of NMP to mission-critical Department of Defense and
National Aeronautics and Space Administration (NASA) operations and
overall military
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readiness is discussed throughout this proposed rule, and detailed in
Unit IV.A.6. While, for example, 29 CFR 1960 sets forth procedures and
guidelines for ensuring that Federal workers are protected in
comparable ways to their private sector counterparts, EPA believes that
compliance with this proposed rulemaking would require increased and
different preparations on the part of Federal agencies. For example,
Federal agencies must follow procurement requirements which will likely
result in increased compliance timelines. In addition, these
requirements would require support in the Federal budget, which, for
some agencies, is a multi-year process. Therefore, EPA is providing an
additional two years for agencies of the Federal Government and their
contractors, when acting for or on behalf of the Federal government, to
comply with the WCPP.
EPA requests comment relative to the ability of owners or operators
in the private sector to implement such processes within 12 months of
publication of the final rule in the Federal Register, and anticipated
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit. EPA also requests comment on
whether the additional two years provided for agencies of the Federal
Government and their contractors, when acting for or on behalf of the
Federal government, to comply with the WCPP, should be provided more
broadly to all entities complying with the WCPP.
EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
4. Prescriptive Controls
a. Overview
In contrast to the proposed non-prescriptive requirements of DDCC
where regulated entities would select controls in accordance with the
hierarchy of controls to comply with the parameters outlined in this
unit, EPA is proposing that it is appropriate in certain circumstances
to require specific prescriptive controls for certain occupational
conditions of use where preventing direct dermal contact through
implementation of a WCPP or a prohibition may not be practicable. EPA's
description for how these requirements would address the unreasonable
risk and the rationale for this regulatory approach is outlined in
Units III.B.3 and V.A.
In the 2020 Risk Evaluation for NMP, and supplemental occupational
risk calculations EPA identified certain prescriptive controls, such as
product reformulation to limit concentration of NMP in certain products
that, in combination with PPE, would reduce exposures from NMP enough
to address the unreasonable risk (Ref. 37). Therefore, EPA is proposing
to require specific prescriptive controls for these occupational uses
of NMP, as described in this unit. The following requirements would
apply to the following conditions of use:
<bullet> A concentration of NMP no greater than 45% in formulated
products, with requirements for appropriate dermal PPE, and any NIOSH
Approved[supreg] air-purifying respirator equipped with organic vapor
cartridges or canisters (minimum APF 10) for:
--Processing--incorporation into articles in paint additives and
coating additives in transportation equipment manufacturing;
--Industrial and commercial use in paints and coatings in lacquers,
stains, varnishes, primers and floor finishes, and powder coatings in
surface preparation;
--Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale and retail trade; and
--Industrial and commercial use in adhesives and sealants including
binding agents, single component glues and adhesives, including
lubricant adhesives and two component glues and adhesives including
some resins.
<bullet> A concentration of NMP no greater than 30% in formulated
products, with requirements for appropriate dermal PPE, and any NIOSH
Approved[supreg] air-purifying respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] powered air-
purifying respirator equipped with NIOSH Approved[supreg] organic vapor
cartridges; or any NIOSH Approved[supreg] continuous flow supplied air
respirator equipped with a hood or helmet (minimum APF 25) for the
industrial and commercial use in paints, coatings, and adhesive
removers.
<bullet> A concentration of NMP no greater than 5% with
requirements for appropriate dermal PPE for the industrial and
commercial use in ink, toner, and colorant products in printer ink.
<bullet> A concentration of NMP no greater than 1% with
requirements for appropriate dermal PPE for the industrial and
commercial use in soldering materials.
This unit describes proposed requirements for concentration (or
weight fraction) limits, appropriate dermal PPE, and respirator types
with additional requirements proposed for recordkeeping. This unit also
describes compliance timeframes for these proposed requirements.
b. Concentration Limits for Industrial and Commercial Uses
EPA is proposing to prohibit the import, processing, distribution
in commerce, or use of the NMP-containing products for the conditions
of use listed in this unit with a concentration greater than those
listed for each condition of use. Specifically, EPA proposes that
processors, or product formulators, would not be permitted to formulate
products for the conditions of use listed in in this unit with a
concentration of NMP greater than specified in this unit. Similarly,
importers of formulated products would be prohibited from importing
products for the conditions of use listed in this unit with a
concentration of NMP greater than specified in this unit. Entities
distributing in commerce products containing NMP would be prohibited
from distributing any products for the conditions of use listed in this
unit with a concentration of NMP greater than specified in this unit.
c. Workplace Requirements
To reduce exposures in the workplace and address the unreasonable
risk of injury to health from NMP identified for the occupational uses
listed in this unit, EPA is proposing both a concentration limit
requirement and PPE requirement. Each owner or operator of a workplace
who imports, processes, or industrially and commercially uses NMP under
the conditions of use listed in this unit would be responsible for
compliance with the requirements outlined in this unit. Specifically,
concentrations of NMP in products used for the conditions of use listed
in this unit would not be permitted to exceed the listed
concentrations, and owners or operators would be responsible for
ensuring requirements for the specified PPE and PPE program laid out in
Unit IV.A.3.c. are met.
EPA is proposing to require appropriate dermal PPE, including
impermeable gloves and protective clothing, in combination with
comprehensive training for tasks with NMP. In selecting and providing
appropriate dermal PPE and providing PPE training, owners and operators
[[Page 51158]]
would be required to follow the PPE program and dermal protection
requirements laid out in Unit IV.A.3.c. Unlike DDCC, this proposed
provision would not require owners and operators to use elimination,
substitution, engineering controls, and administrative controls, prior
to relying on PPE, as a means of controlling exposures in accordance
with the hierarchy of controls. EPA encourages owners and operators to
consider the hierarchy of controls, but is only proposing to require
specific respiratory PPE for several of the conditions of use listed in
this unit, in combination with comprehensive training for tasks with
NMP. In providing the specified respirators and training, owners and
operators would be required to administer a respiratory protection
program with worksite-specific procedures and elements for required
respirator use in accordance with 29 CFR 1910.134(a) through (l),
except 29 CFR 1910.134(d)(1)(iii) and (d)(3)(i)(B), for proper
respirator use, maintenance, fit-testing, medical evaluation, and
training. EPA is proposing that the owner or operator must ensure that
all cartridges, and canisters used in the workplace are labeled and
color coded with the NIOSH approval label and that the label is not
removed and remains legible. 29 CFR 1910.134(d)(3)(iii), which EPA is
proposing to cross-reference, requires either the use of respirators
with an end-of-life service indicator certified by NIOSH for the
contaminant, in this case NMP, or implementation of a change schedule
for canisters and cartridges that ensures that they are changed before
the end of their service life. EPA is requesting comment on whether
there should be a requirement to replace cartridges or canisters after
a certain number of hours, such as the requirements found in OSHA's
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a
requirement for a minimum service life of non-powered air-purifying
respirators such as the requirements found in OSHA's General Industry
Standard for Benzene (29 CFR 1910.1028(g)(3)(D)). Owners and operators
would also be required to follow the PPE program laid out in Unit
IV.A.3.c.
d. Recordkeeping
To support and demonstrate compliance, EPA is proposing that each
owner or operator of a workplace that would be subject to the
prescriptive controls described in this unit (including product
formulators) retain compliance records for five years. EPA is proposing
to require records to include:
(1) Documentation identifying implementation of and compliance with
the concentration limits described in this unit;
(2) Dermal protection used by each potentially exposed person, as
described in this unit;
(3) Respiratory protection used by each potentially exposed person,
as described in this unit; and
(4) PPE program implementation.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA for examination and copying in accordance with EPA
requirements. All records required to be maintained by this unit could
be kept in the most administratively convenient form (electronic or
paper). EPA is requesting public comment on whether additional
documentation should be required to further support compliance and
enforceability of the proposed regulatory requirements (e.g.,
requirements for labels or SDS identifying percent of NMP within a
product, or downstream notification of these proposed requirements for
concentration limits and PPE, or other information that would be made
available to industrial and commercial users to indicate compliance
with the concentration limits).
e. Compliance Timeframes
EPA is proposing to stagger the compliance dates for the proposed
prescriptive controls described in this unit, such that the
requirements would come into effect in 12 months for importers, 15
months for processors, 18 months for distributing to retailers, 21
months for all other distributors (including retailers), 24 months for
industrial and commercial users after the publication date of the final
rule. When proposing these compliance dates as required under TSCA
section 6(d), EPA considered irreversible health effects and risks
associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be impacted, or that
additional time is needed for product reformulation and PPE training.
However, EPA requests comment on whether additional time is needed,
other concentrations are required, or if there are available
substitutes for this application. As discussed in Unit IV.A.1, EPA
recognizes that recent proposed rulemakings under TSCA section 6(a)
have received public comments requesting longer compliance timeframes.
For NMP, EPA believes that the proposed compliance timeframes for the
prescriptive controls described in this unit may present fewer
compliance challenges than those described by commenters on other
rules. For example, for NMP, it may be more feasible to more rapidly
reformulate products containing NMP or to institute workplace controls
to prevent direct dermal contact (in contrast to the challenges of
reducing inhalation exposures). EPA may finalize significantly shorter
or longer compliance timeframes based on consideration of public
comments.
5. Concentration Limits on NMP in Products for Consumer Use in
Adhesives and Sealants in Glues and Adhesives, Including Lubricant
Adhesives
In the 2020 Risk Evaluation, EPA determined that consumer use of
NMP in adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants contributes to the unreasonable risk
from NMP, due to risk of injury to health of consumers (Ref. 1). To
address the unreasonable risk to consumers, EPA is proposing to require
that import, processing, and distribution in commerce (including by
retailers) of NMP and formulated NMP-containing products intended for
consumer use in adhesives and sealants in glues and adhesives,
including lubricant adhesives and sealants be limited to a
concentration of NMP no greater than 45%.
As discussed in Units III.B.3. and V.A., based on consideration of
the severity of the hazards of NMP in conjunction with the limited
options available to address the identified unreasonable risk to
consumers under TSCA section 6(a), EPA is proposing this concentration
limit, supported by additional modeling using the methodology of the
2020 Risk Evaluation for NMP (Ref. 38). EPA is requesting public
comment on whether additional documentation should be required to
further support compliance and enforceability of the proposed
regulatory requirements (e.g., requirements for labels identifying the
percent of NMP within a product or downstream notification of these
proposed requirements for concentration limits).
Similar to the other compliance timeframes described in this unit,
EPA is proposing to stagger the compliance dates for the proposed
concentration limits described in this unit, such that the requirements
would come into effect in 12 months for importers, 15 months
[[Page 51159]]
for processors, 18 months for distributing to retailers, 21 months for
all other distributors (including retailers) after the publication date
of the final rule. When proposing these compliance dates as required
under TSCA section 6(d), EPA considered irreversible health effects and
risks associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be impacted, or that
additional time is needed for product reformulation. However, EPA
requests comment on whether additional time is needed, other
concentrations are required, or if there are available substitutes for
this application. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.
6. Mission- or Safety-Critical Uses of NMP by DOD and NASA
a. Overview
For two conditions of use for which EPA is proposing prescriptive
controls, EPA is aware of specific mission- or safety-critical uses for
which the concentration limits EPA is proposing would negatively impact
DOD and NASA, and for which technically and economically feasible safer
alternatives that benefit health or the environment are not available.
Based on the considerations described in this unit and Unit
V.A.1.c.iii., and in accordance with TSCA section 6(c)(2), EPA is
proposing that the WCPP be allowed for use of NMP at high
concentrations by DOD, NASA, or their contractors within the following
conditions of use:
<bullet> Industrial and commercial use in paints, coatings, and
adhesive removers; and
<bullet> Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation.
For the reasons detailed in Unit V.A.1.c.iii., EPA is restricting
the applicability of the WCPP for industrial and commercial use of high
concentrations of NMP in paint, coating, and adhesive removal and
paints and coatings. EPA is proposing that the conditions under which
the WCPP could apply for this use would be: (1) the use of NMP for
paints and coatings at a concentration greater than 45% and for paint,
coating, and adhesive removers at a concentration greater than 30% by
DOD, NASA, or their contractor(s) performing this work only for Federal
agency projects would be limited to the mission-critical components on
government-operated aerospace vehicles, vessels, and military weapons
systems, including mission- or safety-critical components; (2) The use
of NMP for paints and coatings at a concentration greater than 45% and
for paint, coating, and adhesive removal at a concentration greater
than 30% would have to be conducted at Federal installations, at
Federal industrial facilities, or at Federal contractor facilities
performing paint or coating work, or paint, coating, or adhesive
removal work only for DOD and NASA projects; (3) any of the previously
listed Federal agencies or their contractors who use NMP in paints and
coatings at a concentration greater than 45% or for paint, coating, or
adhesive removal at a concentration greater than 30% must comply with
the WCPP requirements described in Unit IV.A.3., and (4) DOD, NASA, or
their contractors who use NMP in paints and coatings at a concentration
greater than 45%, or for paint, coating, or adhesive removal at a
concentration greater than 30% must provide a certification of their
compliance with the conditions of this use.
b. Self-Certification Requirements
To ensure that any products that exceed the concentration limits
that EPA has identified as necessary for addressing the unreasonable
risk for other industrial and commercial users do not become available
for widespread commercial use, EPA is proposing to require DOD, NASA,
or their contractors who use NMP in paints and coatings at a
concentration greater than 45%, or for paint, coating, or adhesive
removal at a concentration greater than 30% must provide a
certification of their compliance with the conditions of the
applicability of the WCPP for this use. Specifically, each entity must
provide a self-certification describing: (1) their status as either DOD
or NASA, or a contractor to DOD or NASA; and (2) their implementation
of and compliance with the WCPP to purchase and use NMP-containing
products that exceed the concentration limits for other industrial and
commercial users described in this unit.
EPA is proposing the following self-certification statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. The
facility in which this product will be used is a Federal
installation, a Federal industrial facility, or a Federal contractor
facility performing paint or coating work, or paint, coating, or
adhesive removal work for DOD and NASA projects. This facility's
implementation of the Workplace Chemical Protection Program (WCPP)
for NMP was evaluated by qualified personnel and that this facility
has implemented and complies with the WCPP for NMP. Based on my
inquiry of the person or persons who manage the facility and/or
those persons directly responsible for implementing the NMP WCPP,
and to the best of my knowledge and belief, the facility is
implementing the NMP WCPP, including the exposure control plan and
other proper documentation of the actions taken is available at the
facility upon request. I am aware that there are significant
penalties, including the possibility of civil penalties for failing
to comply with these requirements and criminal penalties, including
fines and imprisonment, for knowingly failing to comply with these
requirements. I understand that this certification shall serve as a
certification that this facility will properly implement and comply
with the WCPP for NMP consistent with the applicable regulatory
timelines.
EPA realizes that some facilities may not engage in the NMP uses
listed in this unit at the time this proposed rule is finalized. Owners
or operators that may wish to purchase NMP after publication of the
final rule would still be required to submit the self-certification
statement to the distributor from whom NMP was initially purchased to
purchase NMP, including certifying that the facility for which NMP is
being purchased will implement and comply with the WCPP. EPA is also
proposing that distributors review the self-certification statement to
ensure it is appropriately completed to include the owner or operator's
and the facility's information, as outlined in this unit. EPA is also
proposing to require distributors of NMP to retain invoices, including
the name of the facility purchasing NMP, name of the owner or operator
who is self-certifying, date of sale, and quantity of NMP purchased.
EPA is proposing that the distributors and owners or operators maintain
and retain the self-certification statement and related invoices(s) in
the most administratively convenient form (electronic or paper) and
retain the statement(s) and supporting documentation for five years.
c. Recordkeeping and Downstream Notification
EPA recognizes that for DOD, NASA, or their contractors performing
work for their projects to use paints and coatings and paint, coating,
and adhesive removers containing NMP at concentrations greater than
those proposed for other industrial and commercial use, the upstream
processing (or formulation) and distribution in commerce of those
products should also be allowed to
[[Page 51160]]
continue. For these reasons, EPA proposes that processing and
distributing in commerce NMP for paints and coatings at a concentration
greater than 45%; and for paint, coating, and adhesive removal at a
concentration greater than 30% would adhere to the following
conditions: (1) Entities processing NMP for paints and coatings at a
concentration greater than 45% or for paint, coating, and adhesive
removal at a concentration greater than 30% must comply with the WCPP
requirements described in Unit IV.A.3.; (2) Entities processing or
distributing NMP for paints and coatings at a concentration greater
than 45% or for paint, coating, and adhesive removal at a concentration
greater than 30% must provide downstream notification of the
restrictions on use of these products by adding the following language
to sections 1(c) and 15 of the SDS:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be
distributed in commerce to retailers for any use. After [DATE 21
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], this chemical/product is and can only be distributed in
commerce or processed for the following purposes: paints and
coatings or paint, coating, or adhesive removal by the Department of
Defense (DOD), the National Aeronautics and Space Administration
(NASA), or their contractors, at Federal installations, Federal
industrial facilities, or at Federal contractor facilities
performing work only for DOD and/or NASA projects.
and (3) Entities processing or distributing these products in commerce
would be required to provide a label that meets the requirements
outlined in IV.A.2. that provides similar language to the SDS:
This product contains n-methylpyrrolidone (NMP), a chemical
determined by the Environmental Protection Agency to present
unreasonable risk of injury to health under of the Section 6 of the
Toxic Substances Control Act, based on developmental and
reproductive effects. This product containing NMP is restricted for
use under 40 CFR part 751, subpart C. This product is restricted for
sale and can only be used by the Department of Defense (DOD), the
National Aeronautics and Space Administration (NASA), or their
contractors, at Federal installations, Federal industrial
facilities, or at Federal contractor facilities performing work only
for DOD and NASA projects.
These entities would be subject to the proposed general
recordkeeping requirements discussed in Unit IV.A.7., the WCPP
recordkeeping requirements discussed in Unit IV.A.3.d.iv., and
requirements to maintain records that demonstrate compliance with these
requirements.
EPA requests comments on all aspects of the proposed applicability
of the WCPP to these narrowly described uses of higher concentration
NMP in paint, coating, and adhesive removal and paints and coatings.
EPA also requests comment on whether entities other than DOD, NASA or
its contractors also require high concentration NMP and, if so, the
extent to which lack of availability of high concentration NMP could
impact their operations or pose potential challenges to the supply
chain. Finally, EPA is requesting comment on whether EPA should also
require reporting to EPA during purchasing of NMP for these specific
uses by DOD, NASA, or their contractors and if requiring reporting
could support of enforcement and compliance assurance with this
rulemaking by further assuring that distribution of these high
concentration NMP products for these uses is limited to DOD, NASA, and
their contractors, and if such requirements would impose significant
administrative burdens in addition compliance with the WCPP.
7. Other Requirements
a. Recordkeeping
In addition to the recordkeeping requirements for the WCPP and
prescriptive controls outlined in this unit, for conditions of use that
would not otherwise be prohibited under this proposed regulation, EPA
is also proposing that manufacturers, processors, distributors, and
commercial users maintain ordinary business records, such as invoices
and bills-of-lading, that demonstrate compliance with the prohibitions,
restrictions, and other provisions of this proposed regulation and
maintain such records for a period of 5 years from the date the record
is generated. EPA is proposing that this requirement begin at the
effective date of the rulemaking (60 days following publication of the
final rule in the Federal Register). Recordkeeping requirements would
ensure that owners or operators can demonstrate compliance with the
regulations if necessary. EPA may require more, less, or different
documentation in the final rule based on consideration of public
comments.
b. Downstream Notification
For conditions of use that would not otherwise be prohibited under
this proposed regulation, EPA is proposing that manufacturers
(including importers), processors, and distributors, excluding
retailers, of NMP and NMP-containing products provide downstream
notification of the prohibitions through the SDS required by OSHA under
29 CFR 1910.1200(g) by adding the following language to sections 1(c)
and 15 of the SDS:
AFTER [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], this chemical/product cannot be
distributed in commerce or processed with a concentration of NMP
greater than 0.1% by weight for the following purposes: Processing
incorporation into articles in lubricants and lubricant additives in
machinery manufacturing; Industrial and commercial use in anti-
freeze and de-icing products, automotive care products, and
lubricants and greases; Industrial and commercial use in metal
products not covered elsewhere and lubricant and lubricant additives
including hydrophilic c
[…truncated; see source link]Indexed from Federal Register on June 14, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.