[Federal Register Volume 89, Number 116 (Friday, June 14, 2024)]
[Proposed Rules]
[Pages 51134-51194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12643]
[[Page 51133]]
Vol. 89
Friday,
No. 116
June 14, 2024
Part IV
Environmental Protection Agency
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40 CFR Part 751
n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances
Control Act (TSCA); Proposed Rule
Federal Register / Vol. 89 , No. 116 / Friday, June 14, 2024 /
Proposed Rules
[[Page 51134]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0744; FRL-8330-02-OCSPP]
RIN 2070-AK85
n-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or the ``Agency'') is
proposing to address the unreasonable risk of injury to human health
presented by n-methylpyrrolidone (NMP) under its conditions of use as
documented in EPA's risk evaluation and risk determination for NMP
pursuant to the Toxic Substances Control Act (TSCA). NMP is a widely
used solvent in a variety of industrial, commercial, and consumer
applications including the manufacture and production of electronics
such as semiconductors, polymers, petrochemical products, paints and
coatings, and paint and coating removers. EPA determined that NMP
presents an unreasonable risk of injury to health due to the
significant adverse health effects associated with exposure to NMP,
including developmental post-implantation fetal loss from short-term
exposure and reduced fertility and fecundity from long-term exposure.
Additional adverse effects associated with exposure to NMP include
liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin
irritation, and sensitization. To address the identified unreasonable
risk, EPA is proposing to: prohibit the manufacture (including import),
processing, and distribution in commerce and use of NMP in several
occupational conditions of use; require worker protections through an
NMP workplace chemical protection program (WCPP) or prescriptive
controls (including concentration limits) for most of the occupational
conditions of use; require concentration limits on a consumer product;
regulate certain consumer products to prevent commercial use; and
establish recordkeeping, labeling, and downstream notification
requirements.
DATES: Comments must be received on or before July 29, 2024. Under the
Paperwork Reduction Act (PRA), comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before July 15, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0744, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets/.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Clara Hull, Existing Chemicals
Risk Management Division, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-3954; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
1. General
You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of NMP or products containing NMP. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities include:
Abrasive Product Manufacturing (NAICS Code 327910);
Adhesive Manufacturing (NAICS Code 325520);
Aerospace Product and Parts Manufacturing (NAICS Code
336400);
Agriculture, Construction, and Mining Machinery
Manufacturing (NAICS Code 333100);
Aircraft Manufacturing (NAICS Code 336411);
All Other Automotive Repair and Maintenance (NAICS Code
811198);
All Other Basic Organic Chemical Manufacturing (NAICS Code
325199);
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS Code 325998);
All Other Miscellaneous Electrical Equipment and Component
Manufacturing (NAICS Code 335999);
All Other Miscellaneous Manufacturing (NAICS Code 339999);
All Other Miscellaneous Store Retailers (except Tobacco
Stores) (NAICS Code 453998);
All Other Plastics Product Manufacturing (NAICS Code
326199);
All Other Specialty Trade Contractors (NAICS Code 238990);
Alumina and Aluminum Production and Processing (NAICS Code
331300);
Appliance Repair and Maintenance (NAICS Code 811412);
Architectural and Structural Metals Manufacturing (NAICS
Code 332300);
Art Dealers (NAICS Code 453920);
Artificial and Synthetic Fibers and Filaments
Manufacturing (NAICS Code 325220);
Audio and Video Equipment Manufacturing (NAICS Code
334300);
Automobile Dealers (NAICS Code 441110);
Automotive Body, Paint and Interior Repair and Maintenance
(NAICS Code 811121);
Automotive Exhaust System Repair (NAICS Code 811112);
Automotive Glass Replacement Shops (NAICS Code 811122);
Automotive Oil Change and Lubrication Shops (NAICS Code
811191);
Automotive Parts and Accessories Stores (NAICS Code
441310);
Automotive Transmission Repair (NAICS Code 811113);
Boiler, Tank, and Shipping Container Manufacturing (NAICS
Code 332400);
Books Printing (NAICS Code 323117);
Broadwoven Fabric Mills (NAICS Code 313210);
Car Washes (NAICS Code 811192);
Coating, Engraving, Heat Treating, and Allied Activities
(NAICS Code 332800);
Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS Code 811310);
Commercial and Institutional Building Construction (NAICS
Code 236220);
Commercial and Service Industry Machinery Manufacturing
(NAICS Code 333300);
Commercial Printing (except Screen and Books) (NAICS Code
323111);
Commercial Screen Printing (NAICS Code 323113);
[[Page 51135]]
Commercial, Industrial and Institutional Electric Lighting
Fixture Manufacturing (NAICS Code 335122);
Communication Equipment Repair and Maintenance (NAICS Code
811213);
Communications Equipment Manufacturing (NAICS Code
334200);
Computer and Office Machine Repair and Maintenance (NAICS
Code 811212);
Computer and Peripheral Equipment Manufacturing (NAICS
Code 334100);
Computer Terminal and Other Computer Peripheral Equipment
Manufacturing (NAICS Code 334118);
Consumer Electronics Repair and Maintenance (NAICS Code
811211);
Cut Stock, Resawing Lumber, and Planing (NAICS Code
321912);
Cutlery and Handtool Manufacturing (NAICS Code 332200);
Dental Equipment and Supplies Manufacturing (NAICS Code
339114);
Drywall and Insulation Contractors (NAICS Code 238310);
Electric Lighting Equipment Manufacturing (NAICS Code
335100);
Electrical Contractors and Other Wiring Installation
Contractors (NAICS Code 238210);
Electrical Equipment Manufacturing (NAICS Code 335300);
Engine, Turbine, and Power Transmission Equipment
Manufacturing (NAICS Code 333600);
Executive Offices (NAICS Code 921110);
Fabric Coating Mills (NAICS Code 313320);
Facilities Support Services (NAICS Code 561200);
Flooring Contractors (NAICS Code 238330);
Fluid Power Cylinder and Actuator Manufacturing (NAICS
Code 333995);
Footwear Manufacturing (NAICS Code 316210);
Forging and Stamping (NAICS Code 332100);
Foundries (NAICS Code 331500);
Framing Contractors (NAICS Code 238130);
Furniture Stores (NAICS Code 442110);
General Automotive Repair (NAICS Code 811111);
Glass and Glazing Contractors (NAICS Code 238150);
Hardware Manufacturing (NAICS Code 332500);
Hazardous Waste Treatment and Disposal (NAICS Code
562211);
Highway, Street, and Bridge Construction (NAICS Code
237310);
Home and Garden Equipment Repair and Maintenance (NAICS
Code 811411);
Home Furnishing Merchant Wholesalers (NAICS Code 423220);
Household Appliance Manufacturing (NAICS Code 335200);
Independent Artists, Writers and Performers (NAICS Code
711510);
Industrial Building Construction (NAICS Code 236210);
Industrial Gas Manufacturing (NAICS Code 325120);
Industrial Machinery Manufacturing (NAICS Code 333200);
Investment Advice (NAICS Code 523930);
Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
Code 331100);
Lessors of Other Real Estate Property (NAICS Code 531190);
Machine Shops; Turned Product; and Screw, Nut, and Bolt
Manufacturing (NAICS Code 332700);
Manufacturing and Reproducing Magnetic and Optical Media
(NAICS Code 334600);
Masonry Contractors (NAICS Code 238140);
Materials Recovery Facilities (NAICS Code 562920);
Medical Equipment and Supplies Manufacturing (NAICS Code
339100);
Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS Code 332812);
Metalworking Machinery Manufacturing (NAICS Code 333500);
Miscellaneous Intermediation (NAICS Code 523910);
Motor Vehicle Body and Trailer Manufacturing (NAICS Code
336200);
Motor Vehicle Manufacturing (NAICS Code 336100);
Motor Vehicle Parts Manufacturing (NAICS Code 336300);
Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS Code 423120);
Motor Vehicle Towing (NAICS Code 488410);
Museums (NAICS Code 712110);
Navigational, Measuring, Electromedical, and Control
Instruments Manufacturing (NAICS Code 334500);
New Car Dealers (NAICS Code 441110);
New Housing For-Sale Builders (NAICS Code 236117);
New Multifamily Housing Construction (except For-Sale
Builders) (NAICS Code 236116);
New Single-family Housing Construction (Except For-Sale
Builders) (NAICS Code 236115);
Nitrogenous Fertilizer Manufacturing (NAICS Code 325311);
Nonferrous Metal (except Aluminum) Production and
Processing (NAICS Code 331400);
Non-upholstered Wood Household Furniture Manufacturing
(NAICS Code 337122);
Office Administrative Services (NAICS Code 561110);
Oil and Gas Pipeline and Related Structures Construction
(NAICS Code 237120);
Other Aircraft Part and Auxiliary Equipment Manufacturing7
(NAICS Code 336413);
Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS Code 811118);
Other Basic Inorganic Chemical Manufacturing (NAICS Code
325180);
Other Building Equipment Contractors (NAICS Code 238290);
Other Chemical and Allied Products Merchant Wholesalers
(NAICS Code 424690);
Other Concrete Product Manufacturing (NAICS Code 327390);
Other Construction Material Merchant Wholesalers (NAICS
Code 423390);
Other Electrical Equipment and Component Manufacturing
(NAICS Code 335900);
Other Electronic and Precision Equipment Repair and
Maintenance (NAICS Code 811219);
Other Equipment and Component Manufacturing (NAICS Code
335900);
Other Fabricated Metal Product Manufacturing (NAICS Code
332900);
Other Foundation, Structure, and Building Exterior
Contractors (NAICS Code 238190);
Other General Purpose Machinery Manufacturing (NAICS Code
333900);
Other Heavy and Civil Engineering Construction (NAICS Code
237990);
Other Industrial Machinery Manufacturing (NAICS Code
333249);
Other Measuring and Controlling Device Manufacturing
(NAICS Code 334519);
Other Nonhazardous Waste Treatment and Disposal (NAICS
Code 562219);
Other Personal and Household Goods Repair and Maintenance
(NAICS Code 811490);
Other Professional Equipment and Supplies Merchant
Wholesalers (NAICS Code 423490);
Paint and Coating Manufacturing (NAICS Code 325510);
Painting and Wall Covering Contractors (NAICS Code
238320);
Paper Bag and Coated and Treated Paper Manufacturing
(NAICS Code 322220);
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS Code 325320);
Petrochemical Manufacturing (NAICS Code 325110);
Petroleum and Petroleum Products Merchant Wholesalers
(except Bulk Stations and Terminals) (NAICS Code 424720);
[[Page 51136]]
Petroleum Bulk Stations and Terminals (NAICS Code 424710);
Petroleum Lubricating Oil and Grease Manufacturing (NAICS
Code 324191);
Petroleum Refineries (NAICS Code 324110);
Plastics Material and Resin Manufacturing (NAICS Code
325211);
Plumbing, Heating, and Air-Conditioning Contractors (NAICS
Code 238220);
Polish and Other Sanitation Good Manufacturing (NAICS Code
325612);
Poured Concrete Foundation and Structure Contractors
(NAICS Code 238110);
Power and Communication Line and Related Structures
Construction (NAICS Code 237130);
Railroad Rolling Stock Manufacturing (NAICS Code 336500);
Residential Remodelers (NAICS Code 236118);
Reupholstery and Furniture Repair (NAICS Code 811420);
Roofing Contractors (NAICS Code 238160);
Roofing, Siding, and Insulation Material Merchant
Wholesalers (NAICS Code 423330);
Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS Code 334511);
Semiconductor and Other Electronic Component Manufacturing
(NAICS Code 334400);
Semiconductor and Related Device Manufacturing (NAICS Code
334413);
Semiconductor Machinery Manufacturing (NAICS Code 333242);
Service Establishment Equipment and Supplies Merchant
Wholesalers (NAICS Code 423850);
Ship Building and Repairing (NAICS Code 336611);
Siding Contractors (NAICS Code 238170);
Sign Manufacturing (NAICS Code 339950);
Site Preparation Contractors (NAICS Code 238910);
Soap and Other Detergent Manufacturing (NAICS Code
325611);
Solid Waste Combustors and Incinerators (NAICS Code
562213);
Solid Waste Landfill (NAICS Code 562212);
Sporting Goods Stores (NAICS Code 451110);
Spring and Wire Product Manufacturing (NAICS Code 332600);
Steel Product Manufacturing from Purchased Steel (NAICS
Code 331200);
Storage Battery Manufacturing (NAICS Code 335911);
Structural Steel and Precast Concrete Contractors (NAICS
Code 238120);
Support Activities for Printing (NAICS Code 323120);
Testing Laboratories (NAICS Code 541380);
Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS Code 326150);
Used Car Dealers (NAICS Code 441120);
Used Merchandise Stores (NAICS Code 453310);
Ventilation, Heating, Air-Conditioning, and Commercial
Refrigeration Equipment Manufacturing (NAICS Code 333400);
Water and Sewer Line and Related Structures Construction
(NAICS Code 237110); and
Wood Kitchen Cabinet and Countertop Manufacturing (NAICS
Code 337110).
2. Applicability to Importers and Exporters
This action may also affect certain entities through pre-existing
import certification and export notification requirements under TSCA
(https://www.epa.gov/tsca-import-export-requirements). Persons who
import any chemical substance governed by a final TSCA section 6(a)
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127 (see also 19 CFR 127.28). Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)), and must comply with the export notification requirements in
40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that NMP presents an
unreasonable risk of injury to health, without consideration of costs
or other non-risk factors, including an unreasonable risk to
potentially exposed or susceptible subpopulations (PESS) identified as
relevant to the 2020 Risk Evaluation for NMP by EPA, under the
conditions of use (Refs. 1, 2). The term ``conditions of use'' is
defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the
circumstances under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of. A detailed description of the
conditions of use that EPA evaluated in reaching its determination that
NMP presents an unreasonable risk is in Unit III.B.1. EPA notes that
all TSCA conditions of use of NMP are subject to this proposal.
Accordingly, to address the unreasonable risk, EPA is proposing, under
TSCA section 6(a), to:
(i) Prohibit the manufacture (including import), processing,
distribution in commerce, and use of NMP for five occupational
conditions of use, as described in Unit IV.A.1.;
(ii) Require container size limits and labeling requirements for
the manufacture (including import), processing, and distribution in
commerce of NMP for seven consumer uses, as described in Unit IV.A.2.;
(iii) Require prescriptive controls, including concentration limits
and personal protective equipment (PPE) for seven occupational
conditions of use, as described in Unit IV.A.4.;
(iv) Require strict workplace controls, including an NMP WCPP, that
would include requirements to prevent direct dermal contact with NMP,
for all other occupational conditions of use, as described in Unit
IV.A.3, including the commercial use of paints and coatings and paint,
coating, and adhesive removers containing high concentrations of NMP in
uses essential to the missions of the Department of Defense (DOD) and
National Aeronautics and Space Administration (NASA);
(v) Require a concentration limit on NMP for the import,
processing, and distribution in commerce of one consumer use, as
described in Unit IV.A.5.;
(vi) Establish recordkeeping and downstream notification
requirements, as described in Unit IV.A.7.
[[Page 51137]]
In addition, EPA is proposing to amend the general provisions of 40
CFR part 751, subpart A, to define the following terms so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified under 40 CFR part 751: ``Direct dermal
contact,'' ``Exposure group,'' and ``Restricted area.'' EPA seeks
public comment on all aspects of this proposal. These definitions may
be codified in another rule under 40 CFR part 751 prior to the
publication of the final rulemaking for NMP. EPA seeks public comment
on all aspects of this proposal.
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' NMP was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in December 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in December 2022 (Ref.
3), determining that NMP, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. As a
result, EPA is proposing to take action to the extent necessary so that
NMP no longer presents such risk. The unreasonable risk is described in
Unit III.B.2. and the conditions of use EPA evaluated in reaching its
conclusion that NMP presents unreasonable risk are described in Unit
III.B.1.
NMP's hazards are well established. EPA's 2020 Risk Evaluation for
NMP considered the hazards associated with exposure to NMP and
determined that NMP presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to NMP. Some of the risks of adverse effects from NMP exposure may be
acute and experienced for only a short duration. However, certain short
duration exposures can result in irreversible impacts--such as post-
implantation fetal loss. Other risks may be chronic and result in long-
term impacts that are also irreversible. As described in the 2020 Risk
Evaluation for NMP, post-implantation fetal loss and reduced fertility
and fecundity are the most representative adverse effects of NMP
exposure (Ref. 1). Other significant adverse effects include liver
toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation,
and sensitization. EPA is proposing requirements so that NMP would no
longer present unreasonable risk to human health, including PESS.
EPA is proposing to ban several occupational conditions of use of
NMP, such as processing of NMP for incorporation into articles in
lubricants and as a lubricant additive in machinery manufacturing, and
industrial and commercial use of NMP in anti-freeze and de-icing
products, automotive care products, and lubricants, and greases. For
some of these conditions of use, EPA has not identified any current use
of NMP (e.g., in antifreeze, de-icing products, and lubricants); for
most others, EPA has identified possible alternatives in the
alternative assessment (Ref. 4). The uses that EPA proposes to prohibit
comprise an estimated 18% of the current production volume of NMP. EPA
is not proposing a complete ban on NMP. EPA determined that most
consumer uses do not contribute to the unreasonable risk for NMP,
largely due to the generally low concentration of NMP in consumer
products and the infrequent use by consumers of those products (Ref.
1). However, the commercial use of the same types of products does
contribute to the unreasonable risk because they generally contain
higher concentrations of NMP and are used more frequently in commercial
settings. Therefore, EPA is proposing to regulate these consumer
products in a manner that will help ensure that these products are not
diverted to commercial use, as is further described in Unit V.A.1.a.
This rulemaking also proposes to allow certain uses of NMP to
continue, provided that sufficient worker protection measures and
stringent controls are in place to prevent direct dermal contact to NMP
and address the unreasonable risk driven by direct dermal contact for
most of the occupational conditions of use. For many of the
occupational conditions of use, EPA is proposing strict workplace
controls under a WCPP. These conditions of use include the
manufacturing of NMP, processing NMP as a reactant or intermediate in
plastic material and resin manufacturing and other non-incorporative
processing and use of NMP as a laboratory chemical. These also include
the use of NMP in the manufacture of specialized electronics, such as
magnet wire, semiconductors, and lithium-ion batteries used in a wide
variety of applications including aerospace vehicles or electronic
devices, or the use of NMP in petrochemical manufacturing as a
processing aid in lubricant extraction. These conditions of use
comprise an estimated 44% of the current production volume of NMP. In
many of these industries, EPA expects that facilities will already have
in place the types of exposure controls that EPA proposes to require.
For example, EPA understands that most workplaces using NMP in
semiconductor manufacturing already have stringent controls in place
that reduce workplace exposures. For other conditions of use, because
EPA does not believe or have specific information demonstrating that
direct dermal contact can reasonably be prevented, and expects the
application method, such as spray application, to increase the
contribution to the unreasonable risk from inhalation exposure, EPA is
proposing limits on the weight fraction of NMP in formulated products
in combination with personal protective equipment (PPE) and other
workplace controls to address the unreasonable risk. These conditions
of use include the commercial use of NMP in certain formulations,
including various coatings, such as paint, adhesives, sealants, inks,
and soldering materials in a variety of applications and their
associated removers. These conditions of use comprise an estimated 37%
of the current production volume of NMP. EPA is also proposing a limit
on the weight fraction of NMP in one consumer use of NMP to mitigate
the unreasonable risk to consumers from the use of NMP in adhesives and
sealants.
As noted earlier, the conditions of use that EPA is proposing to
ban comprise an estimated 18% of the current production volume of NMP.
Of the conditions of use that would not be prohibited, EPA expects the
production volume for certain conditions of use to decline over time.
For example, EPA expects the industrial and commercial use of NMP in
paints and coatings to decline over time as formulators either
reformulate to a lower concentration of NMP or away from NMP,
especially as the requirement to meet strict workplace controls could
result in a transition in many workplaces away from NMP to other
chemical alternatives, such as those identified in the alternative
analysis (Ref. 4). For other conditions of use, EPA expects the
production volume to increase over time. For example, EPA expects the
industrial and commercial use of NMP in the manufacture of specialized
electronics, including semiconductors and lithium ion
[[Page 51138]]
batteries, to increase as the global demand for electronic devices
increases.
EPA recognizes that some occupational conditions of use are
important for national security applications or for other critical or
essential uses for which no technically or economically feasible safer
alternatives have been identified. While EPA has identified that
prescriptive controls--including limiting the weight fraction of NMP in
paints, coatings, or paint and coating removers or adhesive removers--
could address the unreasonable risk, EPA also understands that DOD and
NASA use high concentrations of NMP in uses critical to their missions.
In the context of DOD and NASA use, EPA expects that the exposure
controls that could be put into place under the WCPP could address the
unreasonable risk. As a result, EPA is proposing that the WCPP could be
used for specific DOD and NASA uses of high concentrations of NMP from
the proposed prescriptive workplace controls for industrial and
commercial uses of NMP in paints and coatings and for industrial and
commercial uses of NMP in paint, coating, and adhesive removers. More
information about these conditions of use, and their continuance to
ensure aviation, including space vehicles, and military readiness is in
Unit V.A.1.c.iii. EPA emphasizes that information available to EPA does
not indicate that commercial users other than DOD or NASA use such high
concentrations of NMP, or that they have a need for similar paints or
coatings, or paint, coating, or adhesive removal. More information and
EPA's requests for comment on these conditions of use is in Unit
V.A.1.c.iii.
The 2020 Risk Evaluation for NMP assessed the risk of injury to
health from exposure to NMP from the combination of several routes of
exposure, including dermal, inhalation, and vapor through skin
intrusion. The 2020 Risk Evaluation for NMP also compared the relative
exposures from these pathways with and without direct liquid contact.
Table 4-54 in the 2020 Risk Evaluation shows the calculated results,
which show that for most, but not all conditions of use that 99-100% of
exposure to NMP is due to dermal contact with liquid. EPA identified
unreasonable risk for NMP predominately due to the dermal exposure
pathway, as discussed in Units III.B.2. Thus, EPA has not identified
and is not proposing to set an Existing Chemical Exposure Limit (ECEL)
for NMP because such a level would only account for risk resulting from
the inhalation pathway. Addressing inhalation risks alone would not
mitigate the unreasonable risk from NMP. EPA's consideration of an ECEL
for NMP is described further in in Unit V.A.3.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis of the potential incremental
impacts associated with this rulemaking that can be found in the
rulemaking docket (Ref. 5). As described in more detail in the Economic
Analysis (Ref. 5) and in Units VI.D. and X.D., EPA's analysis of the
incremental monetized costs of this proposed rule is estimated to be
$396 million annualized over 20 years at a 3% discount rate and $397
million annualized over 20 years at a 7% discount rate. These costs
take into consideration compliance with implementation of a WCPP, which
would include dermal controls to prevent direct dermal contact,
applicable PPE requirements including as part of prescriptive controls
requirements, and costs for reformulation and container size
restrictions of numerous products. Cost estimates by use category are
provided in the Economic Analysis Table 7-36 (Ref. 5). The most notable
unquantified costs include possible costs from prohibition of use of
NMP for certain conditions of use as changes in labor time or
differences in efficacy for a specific firm's use are unknown to EPA.
Unquantified costs and other uncertainties in the cost analyses are
described more fully in section 7.10 of the Economic Analysis (Ref. 5).
The actions proposed in this rulemaking are expected to achieve
significant health benefits for the American public, most of which,
while tangible and significant, cannot at present be monetized
primarily due to a lack of applicable dose-response functions, which
are the relationships between exposures and any incremental adverse
effects. This issue is not unique to EPA and is a government-wide issue
for many noncancer endpoints. EPA is requesting public comment on
methodologies for developing noncancer human dose-response curves and
valuation methods for the health endpoints identified for NMP in the
Risk Evaluation, specifically willingness to pay studies. Non-monetized
benefits include risk reduction of developmental and reproductive
effects, liver toxicity, kidney toxicity, immunotoxicity,
neurotoxicity, irritation, and sensitization. (Ref. 5) While the
benefits to human health associated with risk reduction of
developmental and reproductive effects, liver toxicity, kidney
toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization
cannot be monetized at present, reductions in occurrence of these
conditions clearly have monetary value to society. The importance of
these reductions in occurrence should not be diminished or dismissed
simply because EPA currently lacks the analytical tools to precisely
monetize the positive societal impacts of this proposed regulation.
Human health risks were found at both chronic and acute exposure
levels. Rather than accumulating over a lifetime, risks were found for
workers exposed to NMP during the course of a workweek, or five days.
The 2020 Risk Evaluation assumed one day of exposure for acute
scenarios, and five days of exposure per week for chronic scenarios.
Blood concentrations of NMP are expected to be eliminated over the
course of a weekend with no exposure to NMP.
The 2020 Risk Evaluation for NMP identified developmental effects
as the most representative adverse effects of acute NMP exposure. EPA
specified post-implantation loss as the critical effect of acute
exposures over the course of a day. Post-implantation loss also
referred to as fetal death or fetal mortality includes miscarriage,
spontaneous abortion, or stillbirth, depending on when in the pregnancy
it occurs. Fetal death may result from a single maternal exposure to
NMP at a developmentally critical period (Ref. 1). Exposure to NMP
during a single day (over 8 hours) was found to present risks of fetal
death; further information is in section 3.2.3 of the 2020 Risk
Evaluation (Ref. 1). While there are some estimates of the cost of
medical treatment for miscarriage and stillbirth, there are no
willingness-to-pay estimates of the value of reduced risk of fetal
death. It is very likely that willingness-to-pay would be much higher
than the costs of medical treatment alone; further information is in
section 8.5.1 of the Economic Analysis (Ref. 5). The impacts of fetal
death, including miscarriage or stillbirth, include mental health
impacts, such as depression and anxiety on the woman experiencing the
death of a fetus, and can also impact partners and spouses (Ref. 5).
Mental health research has consistently identified both miscarriage
(defined as fetal death occurring before the 20th week of gestation)
and stillbirth (defined as fetal death occurring after the 20th week of
gestation) as a significant emotional burden exhibited as anxiety and
depression that can persist; research suggests women and men feel
effects for
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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
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2020 in accordance with TSCA section 6(b) (85 FR 86558, December 30,
2020) (FRL-10017-18). EPA subsequently issued a draft revised TSCA
unreasonable risk determination for NMP (87 FR 39511, July 1, 2022)
(FRL-9943-01-OCSPP), and after public notice and receipt of comments,
published a final revised Unreasonable Risk Determination for NMP (87
FR 77596, December 19, 2022) (FRL-9943-02-OCSPP). The 2020 Risk
Evaluation for NMP and supplemental materials are in docket EPA-HQ-
OPPT-2019-0235, with the December 2022 final revised unreasonable risk
determination and additional materials supporting the risk evaluation
process in docket EPA-HQ-OPPT-2016-0743, on https://www.regulations.gov.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for NMP, EPA evaluated risks associated
with 37 conditions of use within the following categories: manufacture
(including import), processing, distribution in commerce, industrial
and commercial use, consumer use, and disposal. Descriptions of these
conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for NMP
identified significant adverse health effects associated with exposure
to NMP, including developmental effects from acute inhalation and
dermal exposures, and reproductive effects from inhalation and dermal
exposures to NMP. A further discussion of the hazards of NMP is in Unit
III.B.2. The 2020 Risk Evaluation updated the hazard points of
departure (POD) from the draft risk evaluation and 2015 risk assessment
based on updated analyses performed in response to peer review
comments. Updated quantitative analyses of additional studies and
endpoints did not lead to a revised chronic POD, which remained at 183
hr-mg/L blood area-under-the curve (AUC), based on decreased male
fertility. In contrast, updating the quantitative analyses of acute
studies resulted in a revision of the acute POD from 216 mg/L to 437
mg/L peak blood concentration, which resulted in some changes to acute
risk estimates, which impacted the unreasonable risk determination.
Notably, with the updated POD, the consumer risk calculations resulted
in identification of fewer conditions of use contributing to the
unreasonable risk. EPA revised its determination regarding the
contribution to unreasonable risk and did not identify the consumer use
of NMP in paint and coating removers or the consumer use of NMP in
cleaning and furniture care products as contributing to the
unreasonable risk from NMP. This is discussed further in section 5.3 of
the 2020 Risk Evaluation which presented an update to the findings from
the 2015 risk assessment.
2. Revised Unreasonable Risk Determination
EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the 2020 Risk Evaluation
for NMP, to ensure that the risk evaluations upon which risk management
decisions are made, better align with TSCA's objective of protecting
human health and the environment. For NMP, EPA revised the original
unreasonable risk determination based on the 2020 Risk Evaluation for
NMP and issued a final revised unreasonable risk determination in
December 2022 (Ref. 2). EPA revised the risk determination for the 2020
Risk Evaluation for NMP pursuant to TSCA section 6(b) and consistent
with Executive Order 13990 (entitled ``Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis'') and
other Administration priorities (Refs. 18, 19, and 20). The revisions
consisted of making the risk determination based on the whole chemical
substance instead of by individual conditions of use (which resulted in
the revised risk determination superseding the prior ``no unreasonable
risk'' determinations and withdrawing the associated TSCA section
6(i)(1) ``no unreasonable risk'' order) and clarifying that the risk
determination does not reflect an assumption that all workers are
always provided and appropriately wear PPE (Ref. 2). In determining
whether NMP presents unreasonable risk under the conditions of use, EPA
considered relevant risk-related factors, including, but not limited
to: the effects of the chemical substance on health (including non-
cancer risks) and human exposure to the substance under the conditions
of use (including duration, magnitude and frequency of exposure); the
effects of the chemical substance on the environment and environmental
exposure under the conditions of use; the population exposed (including
any PESS); the severity of hazard (including the nature of the hazard,
the irreversibility of the hazard); and uncertainties. EPA also
considered the Agency's confidence in the data used in the risk
estimate. This included an evaluation of the strengths, limitations,
and uncertainties associated with the information used to inform the
risk estimate and the risk characterization. The peer-reviewed PBPK
model used in the 2020 Risk Evaluation allowed EPA to estimate
aggregate exposures from simultaneous dermal, inhalation, and vapor-
through-skin exposures with relatively high confidence.
EPA determined that NMP presents an unreasonable risk of injury to
health. Risks to workers and consumers contribute to the unreasonable
risk from NMP. EPA did not identify risks of injury to the environment
that contribute to the unreasonable risk from NMP. The NMP conditions
of use that EPA evaluated and which contribute to EPA's determination
that the chemical substance poses unreasonable risk to health are
listed in the unreasonable risk determination (Ref. 2) and in Unit
III.B.1.
3. Fenceline Screening Analysis
The 2020 Risk Evaluation for NMP did not fully assess certain
exposure pathways that were or could be regulated under another EPA-
administered statute (see section 1.4.2 of the December 2020 Risk
Evaluation for NMP) (Refs. 1, 2). For NMP, some exposure pathways
received only a screening-level analysis. During problem formulation,
EPA conducted a first-tier screening analysis for the ambient air
pathway to near-field populations downwind from industrial and
commercial facilities releasing NMP, which indicated low risk (83 FR
26998, June 11, 2018) (FRL-9978-40). In the 2020 Risk Evaluation for
NMP, EPA conducted a first-tier analysis to estimate NMP surface water
concentrations and did not identify risks from incidental ingestion or
dermal contact during swimming. This resulted in the ambient air and
drinking water pathways for NMP not being fully assessed in the 2020
Risk Evaluation for NMP. In June 2021, EPA made a policy announcement
on the path forward for TSCA chemical risk evaluations, indicating that
EPA would, among other things, examine whether the exclusion of certain
exposure pathways from the risk evaluations would lead to a failure to
adequately protect fenceline communities (Ref. 3, 21). EPA then
conducted a more robust assessment to identify whether there may be
potential risks to people living near the fenceline of facilities
releasing NMP.
To assess the potential risk to the general population in proximity
to a facility releasing NMP, EPA developed the TSCA Screening Level
Approach for Assessing Ambient Air and Water Exposures to Fenceline
Communities Version 1.0, which was presented to the SACC in March 2022,
with a report issued by the SACC on May 18, 2022 (Ref. 22). This
screening level approach, which EPA believes is effective in accurately
assessing where fenceline
[[Page 51144]]
exposures are of no concern, is discussed in Unit VI.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines, through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or any combination of such activities,
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more of the following requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (TSCA section
6(a)(1)).
Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(TSCA section 6(a)(2)).
Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(TSCA section 6(a)(2)).
Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(TSCA section 6(a)(3)).
Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (TSCA section 6(a)(4)).
Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (TSCA section 6(a)(5)).
Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (TSCA section
6(a)(6)).
Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (TSCA section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk, so
that NMP no longer presents such unreasonable risk. EPA's proposed
regulatory action and alternative regulatory actions are described in
Unit IV. EPA is requesting public comment on all elements of the
proposed regulatory action and the alternative regulatory actions and
is providing notice that based on consideration of comments and any new
information submitted to EPA during the comment period on this proposed
rule, EPA may in the final rule modify elements of the proposed
regulatory action. The public should understand that public comments
could result in changes to elements of the proposed and alternative
regulatory actions when this proposed rule is finalized. For example,
elements such as timelines could be lengthened or shortened,
concentration limits could be modified, or the WCPP could have
provisions within the WCPP added or eliminated.
Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption from a requirement of a TSCA section 6(a) rule
for a specific condition of use if EPA finds that: (1) The specific
condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; (2) Compliance with the
requirement, as applied with respect to the specific condition of use,
would significantly disrupt the national economy, national security, or
critical infrastructure; or (3) The specific condition of use, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety.
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
TSCA section 6(a) rules, to consider and include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. A
description of all TSCA section 6 requirements considered in developing
this proposed regulatory action is in Unit III.B.3., and Unit V.
includes more information regarding EPA's consideration of
alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether
to prohibit or restrict in a manner that substantially prevents a
specific condition of use and in setting an appropriate transition
period for such action, EPA consider, to the extent practicable,
whether technically and economically feasible alternatives that benefit
health or the environment will be reasonably available as substitutes
when the proposed prohibition or restriction takes effect. Unit V.B.
includes more information regarding EPA's consideration of
alternatives, and Unit VI. provides more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
EPA carried out required consultations as described in this unit
and also considered impacts on children's environmental health as part
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
EPA conducted consultations and outreach in developing this
proposed regulatory action. The Agency held a federalism consultation
from July 22 to October 22, 2021, as part of this rulemaking process
and pursuant to Executive Order 13132. This included a background
presentation on September 9, 2020, and a consultation meeting on July
22, 2021. During the consultation, EPA met with state and local
officials early in the process of developing the proposed action to
receive meaningful and timely input into its development (Ref. 23).
During the consultation, participants and EPA discussed additional
reporting requirements as a risk management tool to address the
unreasonable risk, EPA's consideration of safer alternatives, and
potential impacts to drinking water utilities (Ref. 23).
NMP is not manufactured (including imported) processed distributed
in commerce or regulated by Tribal governments. However, EPA consulted
with Tribal officials during the development of this proposed action
(Ref. 24). The Agency held a Tribal consultation from May 21 to August
27, 2021, with meetings scheduled for June 14 and July 14, 2021. Tribal
officials were given the opportunity to meaningfully interact with EPA
risk managers concerning the current status of risk management. During
the consultation, EPA discussed risk management under TSCA section
6(a), findings from the 2020 Risk Evaluation for NMP, types of
information that would be helpful to inform risk management, principles
for transparency during the risk management process, and types of
information EPA is seeking from Tribes (Ref. 24). EPA received no
written comments as part of this consultation.
[[Page 51145]]
In addition to the formal consultations, EPA also conducted
outreach to advocates of communities that might be subject to
disproportionate risk from the exposures to NMP, such as minority
populations, low-income populations, and indigenous peoples. EPA's
Environmental Justice (EJ) consultation occurred from June 3 through
August 27, 2021. On July 7 and July 13, 2021, EPA held public meetings
as part of this consultation. These meetings were held pursuant to and
in compliance with Executive Orders 12898 and 14008. EPA received one
written comment following the EJ meetings, in addition to oral comments
provided during the consultation (Ref. 25). In general, commenters
supported strong outreach to affected communities, encouraged EPA to
follow the hierarchy of controls used by the industrial hygiene
community, favored prohibitions, and noted the uncertainty, and in some
cases the inadequacy, of PPE. Other commenters asked about the Agency's
schedule for a proposed rule while reconsidering certain aspects of the
2020 Risk Evaluation. Additionally, commenters expressed concern that
the adverse health impacts of NMP, particularly to pregnant women and
children, and urged EPA to ban the use of NMP in paint and coating
removers (Ref. 25). As required by section 609(b) of the Regulatory
Flexibility Act (RFA), EPA convened a Small Business Advocacy Review
(SBAR) Panel to obtain advice and recommendations from small entity
representatives (SERs) that potentially would be subject to this
proposed rule's requirements (Ref. 26). EPA met with SERs before and
during Panel proceedings, on March 28 and May 24, 2023. Panel
recommendations are in Unit X.C. and in the Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 27). The Panel report is in the
docket (Ref. 26). Units X.C., X.E., X.F., and X.J. provide more
information regarding the consultations.
2. Other Stakeholder Engagement
In addition to the formal consultations described in Unit X., EPA
held a webinar on February 24, 2021, providing an overview of the TSCA
risk management process and the risk evaluation findings for NMP. EPA
also presented on the risk evaluation and risk management under TSCA
for NMP at a Small Business Administration Office of Advocacy small
business roundtable on February 26, 2021. At both events, EPA staff
provided an overview of the TSCA risk management process and the
findings in the 2020 Risk Evaluation for NMP (Ref. 28). Attendees of
these meetings were given an opportunity to voice their concerns
regarding the risk evaluation and risk management.
Furthermore, EPA engaged in discussions with representatives from
different industries, non-governmental organizations, technical experts
and users of NMP. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 29); meeting
materials and summaries are also in the docket. The purpose of these
discussions was to create awareness and educate stakeholders and
regulated entities on the provisions for risk management required under
TSCA section 6(a); explain the risk evaluation findings; obtain input
from manufacturers, processors, distributors, users, academics,
advisory councils, and members of the public health community about
uses of NMP; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to NMP under the
conditions of use; understand the importance of NMP in the various uses
subject to this proposed rule; compile knowledge about critical uses,
substitute chemicals or alternative methods; identify various standards
and performance specifications; and generate potential risk reduction
strategies. EPA has met with, or otherwise communicated with, a variety
of companies, trade associations and non-governmental organizations to
discuss the topics outlined in this paragraph; a list of external
meetings held during the development of this proposed rule is in the
docket (Ref. 29).
3. Children's Environmental Health
The EPA 2021 Policy on Children's Health (Ref. 30) requires EPA to
protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
early childhood and through adolescence until 21 years of age) and
lifelong health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk
evaluations ``to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' Infants, children, and
pregnant women are listed as examples of subpopulations that may be
considered relevant ``potentially exposed or susceptible
subpopulations'' in the TSCA section 3(12) definition of that term. In
addition, TSCA section 6(a) requires EPA to apply one or more risk
management requirements under TSCA section 6(a) so that NMP no longer
presents an unreasonable risk (including unreasonable risk to PESS).
The 2020 Risk Evaluation for NMP evaluated risks of NMP to workers and
ONUs, consumers and bystanders, people of reproductive age, pregnant
females and the developing embryo/fetus, infants, children and
adolescents, people with pre-existing conditions, and people with lower
metabolic capacity due to life stage, genetic variation, or impaired
liver function as potentially exposed or susceptible subpopulations who
may be at greater risk than the general population of adverse
developmental health effects from exposure to NMP (Ref. 1). For
exposures to infants and males and females of reproductive age,
evidence was found of reproductive and developmental toxicity. The
reproductive and developmental health effects of concern related to
exposures to NMP are reduced male fertility and female fecundity and
post-implantation loss (resorptions and fetal mortality). While the
literature contains methodological limitations in human studies, animal
studies were considered adequate to represent reproductive and
development effects in the 2020 Risk Evaluation for NMP.
The 2020 Risk Evaluation for NMP considered impacts on both
children and adults from occupational and consumer use from inhalation
and dermal exposures, as applicable. For occupational use, the risk
evaluation considered males (>16 years of age) and females of
reproductive age (>16 years of age to less than 50 years of age) for
both dermal and inhalation exposures. For consumer use, EPA evaluated
oral exposures based on children's exposure potential via mouthing
articles for infants (<1 year), infants (1 to 2 years), and small child
(3 to 5 years), and levels were well below the threshold that could
result in risk. Additionally for consumer use, the risk evaluation
considered dermal and inhalation exposures to females of childbearing
age (16 to 49 years) as the most sensitive subpopulation for other
individuals, adults, and children. (Ref. 1)
B. Regulatory Assessment of NMP
1. Description of Conditions of Use
This unit describes the TSCA conditions of use that EPA proposes to
regulate, including the conditions of use
[[Page 51146]]
that EPA evaluated and considered in making its unreasonable risk
determination for the chemical substance NMP. Condition of use
descriptions were obtained from EPA sources such as CDR use codes, the
2020 Risk Evaluation for NMP and related documents, as well as the
Organisation for Economic Co-operation and Development harmonized use
codes and stakeholder engagements. For clarity and transparency, EPA
has narrowly revised the titles for the NMP conditions of use in this
proposed rulemaking from the 2020 Risk Evaluation for NMP by removing
CDR use code terminology ``not described by other codes'' and ``in
other uses'' (Refs. 31, 32). For additional description of the
conditions of use, including process descriptions and worker activities
considered in the risk evaluation, see the Problem Formulation of the
2020 Risk Evaluation for NMP, the 2020 Risk Evaluation for NMP, and
supplemental files (Refs. 33, 1, 34). EPA acknowledges that some of the
terms in this unit may be defined under other statutes. However, the
descriptions here are intended to provide clarity to the regulated
entities who will implement the provisions of this rulemaking under
TSCA section 6(a).
a. Manufacturing
i. Domestic manufacture. This condition of use refers to the making
or producing of a chemical substance within the United States
(including manufacturing for export), or the extraction of a component
chemical substance from a previously existing chemical substance or a
complex combination of substances.
ii. Import. This condition of use refers to the act of causing a
chemical substance or mixture to arrive within the customs territory of
the United States.
b. Processing
i. Processing as a reactant/intermediate in plastic material and
resin manufacturing and other non-incorporative processing. This
condition of use refers to when a chemical substance is used in
chemical reactions for the manufacturing of another chemical substance
or product. Through processing as a reactant or intermediate, NMP
serves as a feedstock in the production of another chemical product via
a chemical reaction in which NMP is completely consumed. For example,
NMP may be used as a polymerization media to manufacture high-
temperature polymers or other uses as an intermediate, as a media for
synthesis, extractions, and purifications, or as some other type of
processing aid.
ii. Processing, incorporation into formulation, mixture or reaction
products in multiple industrial sectors. This condition of use refers
to the process of mixing or blending several raw materials to obtain a
single product or preparation. NMP may be incorporated into various
formulations, mixtures, or reaction products including, but not limited
to:
Adhesives and sealant chemicals in adhesive manufacturing;
Anti-adhesive agents in printing and related support
activities;
Paint additives and coating additives in paint and coating
manufacturing and print ink manufacturing;
Processing aids not otherwise listed in plastic material
and resin manufacturing;
Solvents (for cleaning or degreasing) in non-metallic
mineral product manufacturing, machinery manufacturing, plastic
material and resin manufacturing, primary metal manufacturing, soap and
cleaning compound and toilet preparation manufacturing, transportation
equipment manufacturing, all other chemical product and preparation
manufacturing, printing and related support activities, services,
wholesale and retail trade;
Surface active agents in soap, cleaning compound and
toilet preparation manufacturing;
Plating agents and surface treating agents in fabricated
metal product manufacturing;
Solvents (which become part of product formulation or
mixture) in electrical equipment, appliance and component
manufacturing; other manufacturing; paint and coating manufacturing;
print ink manufacturing; soap, cleaning compound and toilet preparation
manufacturing; transportation equipment manufacturing; all other
chemical product and preparation manufacturing; printing and related
support activities; wholesale and retail trade; and
In oil and gas drilling, extraction and support
activities; plastic material and resin manufacturing; services.
iii. Processing, incorporation into articles in lubricants and
lubricant additives in machinery manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles in lubricants and lubricant additives in machinery
manufacturing, and metal finishing operations conducted as part of
machinery manufacturing. Metal finishing is a broad term used in
industry to include a wide variety of processes that alter the surface
of metal substrates, such as cleaning, coating, etching, and invasive
quality testing.
iv. Processing, incorporation into articles in paint additives and
coating additives in transportation equipment manufacturing. This
condition of use refers to the process or preparation when NMP is
incorporated into articles in paints and coating additives in
transportation equipment manufacturing. Transportation equipment
manufacturing includes motor vehicle parts motor vehicle body and
trailer manufacturing, aerospace product and parts manufacturing,
railroad rolling stock manufacturing, and ship and boat building.
v. Processing, incorporation into articles as a solvent (which
becomes part of a product formulation or mixture) including in
textiles, apparel and leather manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles as a solvent in textiles, apparel and leather manufacturing.
vi. Processing, incorporation into articles in other sectors,
including in plastic product manufacturing. This condition of use
refers to the process or preparation when NMP is incorporated into
articles in other sectors, including in plastic product manufacturing.
For example, NMP may be used to produce polymeric resins pellets and
other shapes that are then converted into final plastic articles.
vii. Processing, repackaging. This condition of use refers to the
preparation of a chemical substance or mixture for distribution in
commerce in a different form, state, or quantity. This includes, but is
not limited to, transferring of NMP from a bulk container into smaller
containers.
viii. Processing, recycling. This condition of use refers to
processing waste streams of NMP at third-party site for the purpose of
recovering materials or otherwise preparing the waste for reuse instead
of disposal. Waste solvents can be restored to a condition that permits
reuse via solvent reclamation/recycling. The recovery process may
involve an initial vapor recovery or mechanical separation step
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and commercial use in paints, coatings, and other
adhesive removers. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing products to remove paints,
coatings, and other adhesive removers from various surfaces indoors or
outdoors including, but not
[[Page 51147]]
limited to, graffiti removal from various surfaces.
ii. Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation. This condition of use refers to the
industrial or commercial application of NMP-containing products
including but not limited to paints and coatings, lacquers, stains,
varnishes, primers and floor finishes, and powder coatings in surface
preparation.
iii. Industrial and commercial use in paint additives in computer
and electronic product manufacturing in electronic parts manufacturing.
This condition of use refers to the industrial or commercial use of NMP
or NMP-containing paint additive and coating additive products in
manufacturing and maintaining electrical or electronic parts including
but not limited to magnet wire coating, capacitor, resistor, coil,
transfer and other inductor manufacturing. This description includes,
but is not limited to, use of NMP as an additive in polymeric coatings
used to coat magnet wires, often to give them thermal and solvent
resistance, and in electrical insulating films.
iv. Industrial and commercial use in paint additives and coating
additives in computer and electronic product manufacturing for use in
semiconductor manufacturing. This condition of use refers to the
industrial or commercial use of NMP or NMP-containing paint additive
and coating additive products in manufacturing and maintaining
semiconductor chip manufacturing. This description includes, but is not
limited to, use of NMP as an ingredient for wafer coating and
photoresist activities.
v. Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale and retail trade. This condition of use refers
to the industrial or commercial application of NMP-containing paint
additive and coating additive products including paints, coatings,
adhesives and sealants used in construction, fabricated metal product
manufacturing, machinery manufacturing, other manufacturing, paint and
coating manufacturing, primary metal manufacturing, transportation
equipment manufacturing, wholesale and retail trade.
vi. Industrial and commercial use as a solvent (for cleaning or
degreasing) in electronic equipment, appliance and component
manufacturing. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing solvent (for cleaning or
degreasing) product in manufacturing and maintaining electrical or
electronic parts including, but not limited to magnet wire coating,
capacitor, resistor, coil, transfer and other inductor manufacturing.
This description includes, but is not limited to, use of NMP as a
solvent in enamels, thinners, and cleaners to remove coatings and masks
and in maintenance and equipment cleaning.
vii. Industrial and commercial use as a solvent (for cleaning or
degreasing) in electronic equipment, appliance and component
manufacturing for use in semiconductor manufacturing. This condition of
use refers to the industrial or commercial use of NMP or NMP-containing
containing solvent (for cleaning or degreasing) product in
manufacturing and maintaining semiconductor chip manufacturing. This
description includes, but is not limited to, the use of NMP for
cleaning and stripping wafer surfaces in preparation for other coating
formulations and in maintenance and equipment cleaning activities.
viii. Industrial and commercial use in ink, toner and colorant
products in printer ink and inks in writing equipment. This condition
of use refers to the industrial or commercial use of NMP in printing
and writing activities with products containing NMP. This includes
printing technologies that use inks containing NMP, such as
lithography, flexography, screen, letterpress, and digital
technologies, which includes electrophotography and inkjet printing.
ix. Industrial and commercial use in processing aids, specific to
petroleum production in petrochemical manufacturing, in oil and gas
drilling, extraction and support activities, and in functional fluids
(closed systems). This condition of use refers to the industrial or
commercial use of NMP to improve the processing characteristics or the
operation of process equipment or to alter or buffer the pH of the
substance or mixture, when added to a process or to a substance or
mixture to be processed specific to petroleum production in
petrochemical manufacturing. This includes, but is not limited to, use
as a processing aid for the extraction, separation, and recovery of
aromatic hydrocarbons and other compounds from oils, natural gas, and
refinery gases. Processing agents do not become a part of the reaction
product and are not intended to affect the function of a substance
created.
x. Industrial and commercial use in adhesives and sealants
including binding agents, single component glues and adhesives,
including lubricant adhesives, and two-compound glues and adhesives
including some resins. This condition of use refers to the industrial
or commercial application of NMP-containing adhesive and sealant
products including binding agents, single and two-component glues and
adhesives, lubricant additives, and some resins.
xi. Industrial and commercial use in soldering materials. This
condition of use refers to the industrial or commercial use of NMP in
soldering materials. Soldering is a process in which two or more
substrates, or parts (usually metal), are joined together by melting a
filler metal material (solder or soldering flux) into the joint and
allowing it to cool, thereby joining the independent parts.
xii. Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases. This
condition of use refers to the industrial or commercial use of
automotive servicing products containing NMP in servicing and
maintenance activities in automotive vehicles. Some products may be
applied through aerosol activities, which typically involve the
application of a solution from pressurized cans or bottles that use
propellant to aerosolize the solution, allowing it to be sprayed onto
substrates.
xiii. Industrial and commercial use in metal products not covered
elsewhere, and lubricant and lubricant additives including hydrophilic
coatings. This condition of use refers to the industrial or commercial
use of NMP in products used in metal finishing. Metal finishing is a
broad term used in industry to include a wide variety of processes that
alter the surface of metal substrates, such as cleaning, coating,
etching, and invasive quality testing.
xiv. Industrial and commercial use in laboratory chemicals. This
condition of use refers to the industrial or commercial use of NMP in
laboratory chemicals. This condition of use refers to the industrial
and commercial use of NMP, often in small quantities, in a laboratory
process or in specialized laboratory equipment for instrument
calibration/maintenance chemical analysis, chemical synthesis, as a
carrier chemical, extracting and purifying other chemicals, dissolving
other substances, executing research, development, test
[[Page 51148]]
and evaluation methods, and similar activities.
xv. Industrial and commercial use in lithium ion battery
manufacturing. This condition of use refers to the industrial or
commercial use of NMP or NMP-containing products in manufacturing and
maintaining lithium-ion battery cell manufacturing.
xvi. Industrial and commercial use in cleaning and degreasing, and
cleaning and furniture care products, including wood cleaners and
gasket removers. This condition of use refers to the industrial or
commercial use of NMP in cleaning or degreasing applications,
including, but not limited to, use in industrial facilities and
commercial shops, as well as products that can be used in multiple
applications including, but not limited to, furniture care products,
wood cleaners, and gasket removers. EPA identified NMP-containing
cleaning products used in applications including, but not limited to,
aerosol degreasing, dip/immersion degreasing and cleaning, wipe
cleaning, and spray application.
xvii. Industrial and commercial use in fertilizer and other
agricultural chemical manufacturing, processing aids and solvents. This
condition of use refers to the industrial or commercial use of NMP in
the synthesis of and as a co-solvent in the formulation of agricultural
chemicals. This description includes the use as an NMP containing
fertilizer additive blended into granular or liquid fertilizers.
d. Consumer Uses
EPA determined that the condition of use in Unit III.B.1.d.v
contributes to the unreasonable risk for NMP. As described in this
unit, while EPA determined that seven of the eight consumer uses of NMP
do not contribute to the unreasonable risk, the commercial counterparts
of these conditions of use do contribute to the unreasonable risk. EPA
determined that the seven consumer uses of NMP do not contribute to the
unreasonable risk largely due to the generally low concentration of NMP
in consumer products and the infrequent use by consumers of those
products. (Ref. 1). However, the commercial use of these types of
products does contribute to the unreasonable risk because of their
generally higher concentrations of NMP or frequency of use in a
commercial setting. Therefore, EPA is proposing upstream regulation of
these seven consumer uses to address the unreasonable risk from NMP by
certain commercial uses so that NMP as a whole chemical no longer
presents unreasonable risk, as further discussed in Unit V.A.1.a. The
consumer uses that do not contribute to the unreasonable risk for NMP
are identified in Unit III.B.1.d.i. through iv. and vi. through viii.
Because the potential use of these consumer products by commercial
users contributes to their unreasonable risk, EPA is proposing upstream
regulation of these consumer conditions of use as described in Unit
IV.A.2.
i. Consumer use in paint and coating removers. This condition of
use refers to consumer use of NMP-containing products in paint and
coating remover products.
ii. Consumer use in adhesive removers. This condition of use refers
to consumer use of NMP-containing products in adhesive remover
products.
iii. Consumer use in paints and coatings in lacquers, stains,
varnishes, primers and floor finishes. This condition of use refers to
consumer use of NMP-containing products in paints and coatings products
including lacquers, stains, varnishes, primers and floor finishes.
iv. Consumer use in paint additives and coating additives in paints
and arts and crafts paints. This condition of use refers to consumer
use of NMP-containing products in paint additive and coating additive
products including paints and arts and crafts paints.
v. Consumer use in adhesives and sealants in glues and adhesives,
including lubricant adhesives. This condition of use refers to consumer
use of NMP-containing products in adhesive and sealant products.
vi. Consumer use in automotive care products. This condition of use
refers to consumer use of NMP-containing products in automotive care
products. This description includes automotive interior cleaning
products.
vii. Consumer use in cleaning and furniture care products,
including wood cleaners and gasket removers. This condition of use
refers to consumer use of NMP-containing products in cleaning and
furniture care products, including wood cleaners and gasket removers.
This description includes cleaners and degreasers and engine cleaners
and degreasers.
viii. Consumer use in lubricant and lubricant additives, including
hydrophilic coatings. This condition of use refers to consumer use of
NMP-containing products in lubricant and lubricant additive products.
e. Disposal
This condition of use refers to the process of disposing generated
waste streams of NMP that are collected either on-site or collected and
transported to a third-party site, such as waste incineration sites,
for disposal.
f. Terminology in This Proposed Rule
For purposes of this proposed rulemaking ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for NMP for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority over ``any manner or method of
commercial use'' under TSCA section 6(a)(5) to reach both.
Additionally, in the 2020 Risk Evaluation for the chemical
substance NMP, EPA identified and assessed all known, intended, and
reasonably foreseen processing, industrial, commercial, and consumer
uses of NMP in order to determine whether NMP as a whole chemical
substance presents unreasonable risks to health and the environment.
EPA determined that all processing, industrial, and commercial uses of
NMP evaluated in the 2020 Risk Evaluation for NMP contribute to the EPA
determination that NMP presents unreasonable risk of injury to health.
As such, for purposes of this risk management rulemaking,
``processing'' refers to all processing, including known, intended, and
reasonably foreseen processing of NMP. Likewise, for the purpose of
this risk management rulemaking, ``industrial and commercial use''
refers to all industrial and commercial uses, including known,
intended, or reasonably foreseen NMP industrial and commercial use.
EPA is not proposing to incorporate the descriptions in Unit
III.B.1.a. through e. into the regulatory text as definitions. EPA
requests comment on whether EPA should promulgate definitions for those
conditions of use evaluated in the 2020 Risk Evaluation for NMP that
would not be prohibited, and, if so, whether the descriptions in this
unit are consistent with the conditions of use evaluated in the 2020
Risk Evaluation for NMP and whether they provide a sufficient level of
detail to improve the clarity and readability of the regulation. EPA
further notes that this proposed rule does not apply to any substance
excluded from the definition of ``chemical substance'' under TSCA
section 3(2)(B)(ii) through (vi). Those exclusions include, but are not
limited to, any pesticide (as defined by the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide; and any food, food
additive, drug, cosmetic, or device,
[[Page 51149]]
as defined in the Federal Food, Drug, and Cosmetic Act (FFDCA) section
201, when manufactured, processed, or distributed in commerce for use
as a food, food additive, drug, cosmetic or device. For example, the
proposed rule does not apply to NMP used as a nail polish remover,
provided it is manufactured, processed, or distributed in commerce for
such use, because nail polish remover is a cosmetic as defined in FFDCA
section 201(i).
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that NMP presents an unreasonable risk of injury
to human health under the conditions of use based on acute and chronic
non-cancer risks. As described in the TSCA section 6(b) 2020 Risk
Evaluation for NMP, EPA identified non-cancer adverse effects from
acute and chronic inhalation and dermal exposures to NMP. EPA
identified that the best representative endpoints for non-cancer
effects were from acute (developmental toxicity) and chronic
(reproductive toxicity) inhalation and dermal exposures for all
conditions of use. Additional risks associated with other adverse
effects (e.g., liver toxicity, kidney toxicity, immunotoxicity,
neurotoxicity, irritation and sensitization) were identified for acute
and chronic inhalation and dermal exposures. EPA did not evaluate
cancer risk from exposure to NMP because NMP is not mutagenic and is
not considered carcinogenic. Unit VI.A. summarizes the health effects
and the magnitude of exposures (Ref. 1).
The 2020 Risk Evaluation for NMP assessed exposure from inhalation,
dermal, and vapor through skin exposure, and identified that the
unreasonable risk of injury to human health is mainly driven by direct
dermal contact with NMP. Therefore, EPA is proposing dermal exposure
controls (or, as needed, prohibitions) to prevent direct dermal contact
with NMP. While inhalation risks contribute to the unreasonable risk
from NMP, addressing inhalation risks alone would not mitigate the
unreasonable risk from NMP. For a small number of conditions of use
where inhalation and dermal exposures both significantly contribute to
the unreasonable risk, EPA is proposing inhalation and dermal exposure
controls. The measures to address the unreasonable risk are discussed
further in Unit IV., and the rationale for these measures are discussed
further in Unit V.
To make the unreasonable risk determination for NMP, EPA evaluated
exposures to workers, ONUs, consumer users, and bystanders to consumer
use using reasonably available monitoring and modeling data for
inhalation and dermal exposures. EPA conducted a screening-level
analysis to assess potential risks from the air and water pathways to
fenceline communities. A discussion of EPA's analysis and the expected
effects of this rulemaking on fenceline communities is in Unit VI.A.
For the 2020 Risk Evaluation for NMP, EPA considered PESS. EPA
identified the following groups as PESS: workers, ONUs, consumers,
bystanders, males and females of reproductive age, pregnant women and
the developing embryo/fetus, infants, children, and adolescents, people
with pre-existing conditions and people with lower metabolic capacity
due to life stage, genetic variation, or impaired liver function (Ref.
1). All PESS are included in the quantitative and qualitative analyses
described in the risk evaluation, and were considered in the
determination of unreasonable risk for NMP. As discussed in Unit II.D.
and Unit VI.A., the 2020 Risk Evaluation for NMP did not fully assess
some exposure pathways, including the air and surface water exposure
pathways to the general population from the published risk evaluations
and may have caused some risks to be unaccounted for in the risk
evaluation. EPA considers these communities a subset of the general
population and categorizes them as fenceline communities; they may also
be considered PESS. See Unit VI.A. for further discussion on assessing
and protecting against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to address the
unreasonable risk for NMP.
As required, EPA developed a proposed regulatory action and an
alternative regulatory action, which are described in Units IV.A. and
IV.B., respectively. To identify and select a regulatory action, EPA
considered the two routes of exposure driving the unreasonable risk,
inhalation and dermal, and the exposed populations. For occupational
conditions of use (see Unit III.B.1.f.), EPA considered how it could
directly regulate manufacturing (including import), processing,
distribution in commerce, industrial and commercial use, or disposal to
address the unreasonable risk. EPA does not have direct authority to
regulate consumer use. Therefore, EPA considered how it could exercise
its authority under TSCA to regulate the manufacturing (including
import), processing, and/or distribution in commerce of NMP at
different points in the supply chain to eliminate exposures or restrict
the availability of NMP and NMP-containing products for consumer use to
address the unreasonable risk.
As required by TSCA Section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions: (i) The effects of NMP on
health and the environment, (ii) The magnitude of exposure to NMP of
human beings and the environment, (iii) The benefits of NMP for various
uses, and (iv) The reasonably ascertainable economic consequences of
the rule. In evaluating the reasonably ascertainable economic
consequences of the rule, EPA considered: (i) The likely effect of the
rule on the national economy, small business, technological innovation,
the environment, and public health; (ii) The costs and benefits of the
proposed regulatory action and alternative regulatory action
considered; and (iii) The cost effectiveness of the proposed regulatory
action and of the alternative regulatory action considered. See Unit
VI. for further discussion related to TSCA section 6(c)(2)(A)
considerations, including the statement of effects of the proposed rule
with respect to these considerations.
EPA also considered the regulatory authority under TSCA and other
statutes such as the OSH Act, Consumer Product Safety Act (CPSA), and
other EPA-administered statutes to examine: (1) Whether there are
opportunities for all or part of risk management action on NMP to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or 9(b); or (2) Whether TSCA section 6(a)
regulation could include alignment of requirements and definitions in
and under existing statutes to minimize confusion to the regulated
entities and the general public.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit IV.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory actions in Unit IV.).
To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy
[[Page 51150]]
of controls adopted by OSHA and NIOSH, with the goal of identifying
risk management control methods that are permanent, feasible, and
effective. EPA also considered how to address the unreasonable risk
while providing flexibility to the regulated entities where
appropriate. EPA considered the information presented in the 2020 Risk
Evaluation for NMP, as well as additional input from stakeholders (as
described in Unit III.A.), and anticipated compliance strategies from
regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and alternative regulatory action described in Unit
IV. Additional details related to how the requirements in this unit
were incorporated into development of those actions are in Unit V.
IV. Proposed and Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
NMP will no longer present an unreasonable risk of injury to health. In
addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost-effectiveness of the proposed
regulatory action and alternative regulatory action. In the case of
NMP, the proposed regulatory action is described in Unit IV.A. and the
alternative regulatory action considered is described in Unit IV.B. An
overview of the proposed regulatory action and alternative regulatory
action for each condition of use is in Unit IV.C. The rationale for the
proposed and alternative regulatory action and associated compliance
timeframes are discussed in this unit and in more detail in Unit V.A.
Discussion of the consideration of TSCA section 6(c)(2)(A) is further
described in Unit VI.
A. Proposed Regulatory Action
EPA is proposing, under TSCA section 6(a) to: Prohibit the
manufacture (including import), processing, distribution in commerce,
and industrial and commercial use of NMP for five occupational uses;
Require container size limits and labeling requirements for the
manufacture (including import), processing, and distribution in
commerce of NMP products for seven consumer uses; Require prescriptive
controls, including concentration limits and PPE, for seven
occupational conditions of use; Require strict workplace controls,
including an NMP WCPP, which would include requirements to prevent
direct dermal contact with NMP, for all other occupational conditions
of use; Require a concentration limit on NMP for the import,
processing, and distribution in commerce for one consumer use; and
Establish recordkeeping and downstream notification requirements.
Pursuant to TSCA section 12(a)(2), this proposed rule would apply to
NMP even if being manufactured, processed, or distributed in commerce
solely for export from the United States because EPA has determined
that NMP presents an unreasonable risk to health or the environment
within the United States.
To aid the regulated community with implementing the prohibitions
and restrictions, and to account for de minimis levels of NMP as an
impurity in products, EPA is proposing that products containing NMP at
concentrations less than 0.1% by weight would not be subject to the
prohibitions and restrictions described in this unit. EPA has
determined that the prohibitions and restrictions would only be
necessary for products containing NMP at levels equal to or greater
than 0.1% by weight to eliminate the unreasonable risk of injury
resulting from inhalation and dermal exposures from NMP-containing
products during occupational and consumer conditions of use. EPA's
description for how allowing for a concentration of NMP up to 0.1%
would not hinder the ability of this rulemaking to address the
unreasonable risk associated with NMP-containing products and rationale
for this regulatory approach are in Unit V.A. EPA requests comment on
allowing this de minimis level of NMP in products to account for
impurities.
1. Prohibition of Certain Occupational Uses and Manufacturing,
Processing, and Distribution in Commerce of NMP for Those Uses
EPA is proposing to prohibit the manufacturing (including import),
processing, distribution in commerce, and use of NMP for the following
conditions of use:
Processing incorporation into articles in lubricants and
lubricant additives in machinery manufacturing;
Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases;
Industrial and commercial use in metal products not
covered elsewhere and lubricant and lubricant additives including
hydrophilic coatings;
Industrial and commercial use in cleaning and degreasing
and cleaning and furniture care products, including wood cleaners and
gasket removers; and
Industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents.
The industrial and commercial uses of NMP in specialized
electronics, such as lithium ion battery manufacturing for use in
electronic vehicles or semiconductor manufacturing, and the associated
upstream manufacturing (including import) and processing uses are not
prohibited. EPA supports the continuation of these specialized
electronic uses while addressing the unreasonable risk through
appropriate exposure controls, detailed in Unit IV.A.3.
As discussed in Units III.B.3. and V.A., based on the Agency's
consideration of alternatives under TSCA section 6(c)(2)(C),
uncertainty relative to the feasibility of exposure reduction to
sufficiently address the unreasonable risk across the broad range of
work environments and activities, and the irreversible health effects
associated with NMP exposures, EPA has determined that prohibition of
the conditions of use identified in this unit is the best way to
address the unreasonable risk from NMP. EPA believes there are a
sufficient number of alternatives for these uses, described further in
Unit V.B. and the Alternatives Assessment (Ref. 4).
EPA is proposing that the prohibitions on manufacturing (including
import), processing, distribution in commerce, and industrial and
commercial use of NMP for these conditions of use would follow a
staggered schedule, due to supply chain considerations. EPA proposes
that the compliance dates for the proposed prohibitions described in
this unit would come into effect in 12 months for manufacturers, 15
months for processers, 18 months for distributing to retailers, 21
months for all other distributors (including retailers), and 24 months
for industrial and commercial users after the publication date of the
final rule. When proposing these compliance dates as required under
TSCA section 6(d), EPA considered irreversible health effects and risks
associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be prohibited, or that
additional time is needed for products to clear the channels of trade.
For NMP, for the conditions of use EPA is proposing to prohibit, the
Agency believes either NMP may no longer be used or regulated entities
would be able to meet the proposed or alternative compliance timeframes
due to availability of alternatives. EPA recognizes that for other
proposed regulations under TSCA
[[Page 51151]]
section 6, including methylene chloride (88 FR 28284, May 3, 20230
(FRL-8155-02-OCSPP), perchloroethylene (88 FR 39652, June 16, 2023)
(FRL-8329-02-OCSPP), and carbon tetrachloride (88 FR 49180, July 28,
2023) (RL-8206-01-OCSPP), public comments have provided information in
support of longer compliance timeframes. Similarly, for NMP, EPA
requests comment on whether additional time is needed, for example, for
products to clear the channels of trade, or for implementing the use of
substitutes. Comments should include documentation such as the specific
use of the chemical throughout the supply chain; concrete steps taken
to identify, test, and qualify substitutes for those uses (including
details on the substitutes tested and the specific certifications that
would require updating); and estimates of the time required to
identify, test, and qualify substitutes with supporting documentation.
EPA also requests comment on whether these are the appropriate types of
information for use in evaluating compliance requirements, and whether
there are other considerations that should apply. EPA may finalize
significantly shorter or longer compliance timeframes based on
consideration of public comments. EPA is also requesting comment on:
(1) whether respiratory protection and dermal PPE should be required
before the effective date of the prohibition; (2) to what extent
inhalation and dermal PPE may already be implemented in most uses being
prohibited; and (3) whether requirements that inhalation and dermal PPE
be used before the effective dates of prohibitions would be overly
burdensome to entities indicated in this unit that would be working to
comply with the prohibition. EPA is requesting comments from the public
for more information about the uses EPA is proposing to prohibit,
particularly the industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents, and
the ability for workplaces in these conditions of use to comply with
strict workplace controls like those required under the WCPP, or the
ability to comply with a prohibition and reformulate to an alternative
chemical or process.
Additionally, EPA recognizes that there may be instances where an
ongoing use of NMP that has implications for national security or
critical infrastructure as it relates to other Federal agencies (e.g.,
DOD, DOE, NASA) is identified after the NMP rule is finalized, but the
final rule prohibits that use. For instances like that, EPA requests
comments on an appropriate, predictable process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued using the tools
available under TSCA, aligning with the requirements of TSCA section
6(g). One example of an approach could be the establishment by
rulemaking of a Federal agency category of use that would require
implementation of the WCPP and periodic reporting to EPA on details of
the use as well as progress in discontinuing the use or finding a
suitable alternative. To utilize the category of use a Federal agency
would petition EPA, supported by documentation describing the specific
use (including documentation of the specific need, service life of any
relevant equipment, and specific identification of any applicable
regulatory requirements or certifications, as well as the location and
quantity of the chemical being used); the implications of cessation of
this use for national security or critical infrastructure (including
how the specific use would prevent injuries/fatalities or otherwise
provide life-supporting functions); exposure control plan; and, for
Federal agency uses where similar adoption by the commercial sector may
be likely, concrete steps taken to identify, test, and qualify
substitutes for the uses (including details on the substitutes tested
and the specific certifications that would require updating; and
estimates of the time required to identify, test, and qualify
substitutes with supporting documentation). In the event that sensitive
information relating to national security or critical infrastructure
would be submitted to EPA, EPA would protect the submitted information
in accordance with applicable authorities. EPA requests comment on
whether these are the appropriate types of information for use in
evaluating this type of category of use, and whether there are other
considerations that should apply. EPA would make a decision on the
petition within 30 days and publish the decision in the Federal
Register shortly after. Additionally, during the year following the
petition, EPA would take public comment on the approved petition and no
later than 180 days after submitting the petition to EPA, the
requesting agency would submit monitoring data indicating compliance
with the WCPP at each relevant location as well as documentation of
efforts to identify or qualify substitutes. In the absence of that
confirmatory data, the utilization of the generic Federal agency
category of use would expire within one year of the date of receipt by
EPA of the petition. EPA could undertake a TSCA section 6(g) rulemaking
for those instances where the Federal agency could not demonstrate
compliance with the WCPP. This is just one example of a potential
process. EPA requests comments on a process that could expedite
reconsideration for uses that Federal agencies or their contractors
become aware of after the final rule is issued.
EPA continues to work with Federal agency partners to develop a
regulatory approach to accommodate uses needed for national security or
critical infrastructure purposes in a manner that complies with EPA
requirements for implementation of a workplace chemical protection plan
(WCPP) and any other EPA identified protective measures intended to
mitigate an unreasonable risk of injury to health or the environment.
EPA solicits comment on all aspects of its steps to accommodate these
uses in this proposed rule and whether any additional measures are
needed.
2. Container Size Restrictions and Labeling Requirements
EPA has identified consumer products similar to the commercial
products proposed to be prohibited. While EPA determined that the
consumer uses of NMP listed in this unit do not contribute to the
unreasonable risk, EPA found that the commercial counterparts of these
conditions of use do contribute to the unreasonable risk due to the
increased exposure from more frequent use. As described in Unit
III.B.3., under TSCA section 6(a), EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. As such, EPA is proposing tailored upstream regulations for
these consumer conditions of use to manage the exposures to similar
commercial conditions of use. In this way, NMP would not present
unreasonable risk to workers. These restrictions are intended to
prevent the consumer products intended for consumer use from being
unlawfully used in commercial activities. EPA is proposing to prohibit
the import, processing, and distribution in commerce of NMP or NMP-
containing products for these consumer uses of NMP if the containers
exceed a
[[Page 51152]]
volume more than 16 ounces. The rationale for this container size
volume is described in Unit V.A.1.b.
EPA is proposing to restrict the container size and require labels
for NMP-containing products for the following consumer uses:
In paint and coating removers;
In adhesive removers;
In paints and coatings in lacquer, stains, varnishes,
primers and floor finishes;
In paint additives and coating additives in paints and
arts and crafts paints;
In automotive care products;
In cleaning and furniture care products, including wood
cleaners, gasket removers; and
In lubricant and lubricant additives, including
hydrophilic coatings.
EPA is requesting public comment on whether meeting this container
size restriction to prevent commercial use would also have the same,
though unintended, effect of reducing the consumer use.
Additionally, to prevent commercial use of these consumer products,
EPA is proposing to require all importers, processors, and distributors
in commerce of the NMP-containing products for the conditions of use
listed in this unit to provide a label securely attached to each
product. Label information would be required to be prominently
displayed in an easily readable font size, and contain the following
text including the sentence ``This product is only for sale in
containers of 16 ounces or less and is for consumer use only'' in
italic print or a larger font for emphasis:
This product contains n-methylpyrrolidone (NMP) (CASRN 872-50-
4), also called n-methyl-2-pyrrolidone or 1-methyl-2-pyrrolidone, a
chemical determined by the Environmental Protection Agency to
present unreasonable risk of injury to health under the Toxic
Substances Control Act (TSCA), based on developmental and
reproductive effects. The use of NMP is restricted under 40 CFR part
751, subpart C. This product is only for sale in containers of 16
ounces or less and is for consumer use only. This product shall not
be used for commercial purposes.
EPA is proposing that the container size limit and labeling
requirements described in this unit take effect 12 months after the
publication date of the final rule in the Federal Register for import,
processing, and distribution in commerce. EPA has no reasonably
available information indicating these proposed compliance dates are
not practicable for the activities that would require repackaging and
labeling or that additional time is needed for products to clear the
channels of trade. However, EPA requests comment on whether additional
time is needed, for example, for products to clear the channels of
trade, or for implementing the container size restriction, and on what
an appropriate container size restriction should be if not 16 ounces,
and why. EPA is also seeking public comment on any alternative options
to prevent diversion of consumer products to commercial uses. Comments
should include documentation such as the specific container sizes of
the NMP-containing products and estimates of the time and expenses
required to implement the labeling requirement. EPA may finalize
significantly shorter or longer compliance timeframes based on
consideration of public comments.
3. Workplace Chemical Protection Program (WCPP) for Certain Conditions
of Use
a. Overview
EPA is proposing Direct Dermal Contact Control (DDCC) requirements
as part of the WCPP for the manufacturing, processing, and use of NMP
for all industrial and commercial uses, except for those conditions of
use which would be prohibited (as described in Unit IV.A.1) or subject
to prescriptive controls (as described in Unit IV A.4). This would
include requirements to comply with the WCPP for the following
conditions of use:
Manufacturing (domestic manufacturing);
Manufacturing (import);
All processing, excluding conditions of use for which
prohibition or prescriptive controls are proposed (which are listed in
Unit IV.A.1 and IV.A.4, respectively). All processing includes, but is
not limited to: processing as a reactant or intermediate in plastic
material and resin manufacturing and other non-incorporative
processing; processing incorporation into a formulation, mixture or
reaction product in multiple industrial sectors; processing
incorporation into articles as a solvent (which becomes part of a
product formulation or mixture) including in textiles, apparel and
leather manufacturing; processing incorporation into articles in other
sectors, including in plastic product manufacturing; processing by
repackaging in wholesale and retail trade; processing by recycling;
All industrial and commercial uses, excluding conditions
of use for which prohibition or prescriptive controls are proposed
(which are listed in Units IV.A.1 and IV.A.4, respectively). All
industrial and commercial uses includes, but is not limited to:
industrial and commercial use in paint additives and coating additives
in computer and electronic product manufacturing in electronic parts
manufacturing; industrial and commercial use in paint additives and
coating additives in computer and electronic product manufacturing in
semiconductor manufacturing; industrial and commercial use as a solvent
(for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing; industrial and commercial use as a solvent
(for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing for use in semiconductor manufacturing;
industrial and commercial use in processing aids, specific to petroleum
production in petrochemical manufacturing in oil and gas drilling,
extraction and support activities, and in functional fluids (close
systems); industrial and commercial use in laboratory chemicals;
industrial and commercial uses in lithium ion battery manufacturing;
industrial and commercial use in paints and coatings and paint,
coating, and adhesive removers by DOD, NASA, and their contractor for
mission-critical components on government-operated aerospace vehicles,
vessels, and military weapons systems, including mission- or safety-
critical components; and
Disposal.
As described in Unit III.B.3., EPA is required to issue a
regulation applying one or more of the TSCA section 6(a) requirements
to the extent necessary so that the unreasonable risk of injury to
health or the environment from a chemical substance is no longer
presented. The TSCA section 6(a) requirements provide EPA the authority
to limit or restrict a number of activities, alone or in combination,
including the manufacture, processing, distribution in commerce,
commercial use, and disposal of the chemical substance. Given this
authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational (e.g.,
manufacturing, processing, industrial and commercial use, and disposal)
conditions of use. The WCPP for NMP would encompass DDCC requirements,
and the associated implementation requirements described in this unit
to ensure that the chemical substance no longer presents unreasonable
risk.
Under a WCPP, owners or operators would have some flexibility,
within the parameters outlined in this unit, regarding how they prevent
direct dermal contact. In the case of NMP,
[[Page 51153]]
implementing the DDCC requirements for certain occupational conditions
of use would address unreasonable risk to potentially exposed persons
from dermal exposure.
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where NMP is present and who may be exposed to NMP under
the conditions of use for which a WCPP would apply. One important
reason to define a potentially exposed person for the purposes of a
WCPP as any person who may be exposed in the workplace is to emphasize
the broad scope of exposures which must be categorized when
implementing a WCPP. EPA notes that this definition is intended to
apply only in the context of risk management, and specifically in the
context of a WCPP (e.g., workers directly using the chemical, workers
in the vicinity of the use, students in a laboratory setting). The term
is not intended as a replacement for the term Potentially Exposed or
Susceptible Subpopulation as defined by TSCA section 3(12). EPA
additionally recognizes that other individuals or communities may be
exposed to NMP as consumers, members of fenceline communities, or
members of the general population, which is separate and apart from
those potentially exposed for the purposes of the regulatory
requirements of the WCPP. In those instances, where regulatory
requirements address exposures unrelated to a WCPP EPA would use
distinct terminology to refer to those other populations. EPA's
intention is to require a comprehensive WCPP that would address the
unreasonable risks from NMP to potentially exposed persons directly
handling the chemical or in the area where the chemical is being used.
Similarly, the 2020 risk evaluation for NMP did not distinguish
between employers, contractors, or other legal entities or businesses
that manufacture, process, distribute in commerce, use, or dispose of
NMP.
EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use is occurring and NMP is present. The term
includes any person who owns, leases, operates, controls, or supervises
such a workplace.
DDCC requirements are process-based approaches to prevent direct
dermal contact with NMP and associated implementation requirements
described in this unit to ensure that the chemical substance no longer
presents unreasonable risk from dermal exposure. DDCC requirements
allow regulated entities some flexibility within certain parameters
outlined in this unit for preventing direct dermal contact with NMP. In
the case of NMP, EPA has preliminarily determined that preventing
direct dermal contact through DDCC requirements for certain conditions
of use would address their contribution to the unreasonable risk from
NMP. NMP is slightly volatile, and preventing direct dermal contact
with NMP would also inherently reduce inhalation exposure by reducing
concentration of NMP in air from volatilization, further preventing
unreasonable risk to workers.
This unit includes a summary of the proposed NMP WCPP, including a
description of the proposed DDCC requirements and associated
implementation requirements; consideration of the NIOSH hierarchy of
controls (hereafter referred to as ``hierarchy of controls''); and
additional requirements proposed for recordkeeping, workplace training,
workplace participation, and notification. This unit also describes
compliance timeframes for these proposed requirements.
b. Direct Dermal Contact Control (DDCC) Requirements
i. Direct dermal contact. DDCC requirements are a process-based set
of provisions to address unreasonable risk driven by dermal exposure by
preventing direct dermal contact in the workplace. To address the
unreasonable risk driven by dermal exposure to NMP, DDCC requirements
would include controls to separate, distance, physically remove, or
isolate all person(s) from direct handling of NMP or from skin contact
with surfaces that may be contaminated with NMP (i.e., equipment or
materials on which NMP may be present) under routine conditions in the
workplace (hereafter referred to as direct dermal contact). The 2020
Risk Evaluation for NMP assessed risks to workers from inhalation and
dermal exposure, and concluded the risk was driven by the dermal
exposure, mainly direct skin contact with NMP. Risk exceeding the
benchmark was identified even when considering use of chemically
resistant gloves in most commercial and industrial conditions of use.
The 2020 Risk Evaluation deduced that direct dermal contact drives the
unreasonable risk by comparing the internal exposure to workers with
inhalation, vapor through skin and dermal liquid contact with internal
exposure to ONUs due to inhalation and vapor through skin exposure (a
subtraction technique). The percent exposure to NMP due to dermal
contact with liquid is provided in table 4-54 in section 4.3.7 of the
2020 Risk Evaluation (Ref. 1). EPA's description for how the
requirements related to DDCC would address the unreasonable risk
resulting from dermal exposures and the rationale for this regulatory
approach is outlined in Units III.B.3. and V.A.
As part of DDCC requirements, EPA is proposing to require owners
and operators to implement dermal exposure controls in accordance with
the hierarchy of controls. EPA also recommends and encourages the use
of pollution prevention as a means of controlling exposures whenever
practicable. EPA is also proposing to align DDCC requirements with the
implementation of several OSHA standards, including the hazard
communication (29 CFR 1910.1200) and general PPE requirements standards
(29 CFR 1910.132), recognizing that OSHA has not set an exposure limit
for inhalation or direct dermal exposure for NMP.
Within certain parameters outlined in this unit, DDCC requirements
are non-prescriptive, in the sense that it does not require a specific
control to prevent direct dermal contact. Rather, it would enable
regulated entities to determine how to most effectively prevent direct
dermal contact based on what works best for their workplace, in
accordance with the hierarchy of controls. Each owner or operator of a
workplace engaging in a condition of use for which DDCC requirements
are proposed would be responsible for compliance with the DDCC
requirements and recordkeeping.
As discussed briefly in Unit IV.A.1. and further in Unit V.A.1.,
EPA expects that many workplaces already have stringent controls in
place that reduce dermal exposures to NMP; for some workplaces, EPA
understands that these existing controls may already prevent or reduce
direct dermal contact with NMP to the extent necessary to address the
unreasonable risk.
ii. Incorporation of the hierarchy of controls. EPA is proposing to
require owners or operators to implement DDCC requirements in
accordance with the hierarchy of controls and encourages the use of
pollution prevention to control exposures whenever practicable. EPA
recognizes that some owners or operators may have industrial hygiene
practices already preventing direct dermal contact with NMP in the
workplace. For example, the semiconductor sector has provided EPA
[[Page 51154]]
with information about the exposure reduction measures in their
facilities, which are aligned with industrial hygiene best practices to
prevent direct dermal contact with NMP, similar to that EPA is
proposing. For workplaces that cannot feasibly eliminate the source of
NMP dermal exposure or replace NMP with a substitute, workplaces would
have to use engineering and/or administrative controls to implement
process changes to prevent direct dermal contact with NMP to the extent
feasible. If an owner or operator chooses to replace NMP with a
substitute, EPA recommends that they carefully review the available
hazard and exposure information on the potential substitutes to avoid a
regrettable substitution, including alternatives identified in the
Alternatives Analysis, which is further described in Unit V.B. If an
effort to identify and implement feasible exposure controls such as
elimination, substitution, engineering controls and administrative
controls is not sufficient to prevent direct dermal contact with NMP
for potentially exposed persons in the workplace, EPA proposes to
require each owner and operator to reduce to the extent practicable the
potential for direct dermal contact with NMP in the workplace by these
controls and to supplement these controls using PPE. Examples of
engineering controls that may prevent or reduce the potential for
direct dermal contact include automation, physical barriers between
contaminated and clean work areas, enclosed transfer liquid lines (with
purging mechanisms in place (e.g., nitrogen, aqueous) for operations
such as product changes or cleaning), and design of tools (e.g., a
closed-loop container system providing contact-free connection for
unloading fresh and collecting spent solvents, pneumatic tools, tongs,
funnels, glove bags, etc.). Examples of administrative controls that
may prevent or reduce the potential for direct dermal contact include
adjusting work practices (i.e., implementing policies and procedures)
such as providing safe working distances from areas where direct
handling of NMP may occur.
EPA requests comment on available approaches, specifically
monitoring methods (e.g., charcoal patch testing) and frequency of
sampling, to determine the effectiveness of engineering and
administrative controls in preventing or reducing potential direct
dermal contact to NMP. EPA also requests comment on whether requiring
reporting on such monitoring could support enforcement and compliance
assurance with this rulemaking.
EPA proposes to require that owners and operators document their
implementation efforts and compliance with DDCC requirements in an
exposure control plan or through any existing documentation of the
facility's ``Safety and Health Program'' that may already be developed
as part of meeting OSHA requirements or other safety and health
standards (Ref. 35), as described in Unit IV.A.3.d.
iii. Restricted area. EPA is proposing to require that each owner
or operator subject to a WCPP designate any area where direct dermal
contact with NMP may occur (after considering elimination,
substitution, engineering controls, and administrative controls) as a
``restricted area.'' This restricted area would be demarcated using
administrative controls such as highly visible signifiers, in multiple
languages as appropriate (e.g., based on languages spoken by
potentially exposed persons who work in the restricted area), placed in
conspicuous areas and documented through training and recordkeeping.
EPA proposes to require that each owner or operator prevent access to
the ``restricted area'' for any potentially exposed person that lacks
proper training; is not wearing required PPE; or is otherwise
unauthorized to enter. EPA requests comment on whether there should be
general housekeeping or cleaning requirements in areas where the NMP is
handled or where surfaces may be contaminated with NMP. EPA is also
soliciting comment on requiring warning signs to demarcate restricted
areas, similar to the requirements found in OSHA's General Industry
Standard for Beryllium (29 CFR 1910.1024(m)(2)).
c. Personal Protective Equipment (PPE) Program
Where elimination, substitution, engineering controls, and
administrative controls are not feasible or sufficient to fully prevent
direct dermal contact with NMP, EPA is proposing to require
implementation of a PPE program in alignment with OSHA's General
Requirements for Personal Protective Equipment at 29 CFR 1910.132. In
choosing appropriate PPE, owners and operators would be required to
select gloves (which may require glove testing), clothing, and
protective gear (which covers any exposed dermal area of arms, legs,
torso, and face) based on specifications from the manufacturer or
supplier that demonstrate an impervious barrier to NMP during expected
durations of use and normal conditions of exposure within the
workplace, accounting for potential chemical permeation or breakthrough
times. Where respirators are prescribed, as described in Unit IV.A.4.,
EPA is proposing to require each owner or operator select respiratory
protection in accordance with the guidelines described in this unit and
29 CFR 1910.134(a) through (l), except (d)(1)(iii) and (d)(3)(i)(B),
for proper respirator use, maintenance, fit-testing, medical
evaluation, and training.
Owners and operators would be required to select dermal PPE in
accordance with provisions of 29 CFR 1910.132 and in alignment with the
OSHA Hand Protection PPE Standard (29 CFR 1910.138); owners and
operators would also be required to select dermal PPE based on an
evaluation of the performance characteristics of the PPE relative to
the task(s) to be performed, conditions present, and the duration of
use. Further information related to choosing appropriate PPE, including
specific examples of PPE types, can be found in appendix F of the Risk
Evaluation (Ref. 1).
For example, owners and operators could select gloves that have
been tested in accordance with the American Society for Testing
Material (ASTM) F739 ``Standard Test Method for Permeation of Liquids
and Gases through Protective Clothing Materials under Conditions of
Continuous Contact.'' EPA is proposing that PPE be provided for use for
a time period only to the extent and no longer than the time period for
which testing has demonstrated that the PPE will be impermeable during
expected durations of use and conditions of exposure. EPA is proposing
to require that owners and operators also consider other factors when
selecting appropriate PPE, including effectiveness of glove type when
preventing exposures from NMP alone and in likely combination with
other chemical substances used in the work area or when used with glove
liners, permeation, degree of dexterity required to perform tasks, and
temperature, as identified in the Hand Protection section of OSHA's
Personal Protective Equipment Guidance and in alignment with the OSHA
Hand Protection PPE Standard (29 CFR 1910.138), owners and operators
would be required to select dermal PPE based on an evaluation of the
performance characteristics of the PPE relative to the task(s) to be
performed, conditions present, and the duration of use (Ref. 36).
EPA is proposing that owners and operators would be required to
establish, either through manufacturer or supplier-provided
documentation or individually prepared third-party testing, that the
selected PPE would be
[[Page 51155]]
impervious for the expected duration and conditions of exposure by
reporting cumulative permeation rate as a function of time (e.g., by
using the suggested format presented in ASTM F1194, ``Standard Guide
for Documenting the Results of Chemical Permeation Testing of Materials
Used in Protective Clothing,'' or equivalent manufacturer- or supplier-
provided testing). Owners and operators would also be required to
consider likely combinations of chemical substances to which the
clothing may be exposed in the work area when selecting the appropriate
PPE such that the PPE will prevent direct dermal contact to NMP. EPA is
proposing that PPE must be immediately provided and replaced if any
person is dermally exposed to NMP longer than the breakthrough time
period for which testing has demonstrated that the PPE will be
impermeable or if there is a chemical permeation or breakage of the
PPE.
Also consistent with 29 CFR 1910.132, owners and operators would be
required to provide any person in the workplace with PPE and provide
training on proper use (e.g., when and where PPE is necessary, proper
application, wear, and removal of PPE, and maintenance, useful life and
disposal of PPE) where the potential for direct dermal contact with NMP
may exist. Owners and operators would also have to re-train any
affected persons potentially exposed to direct dermal contact with NMP
whenever the owner or operator has reason to believe that a previously
trained person does not have the required understanding and skill to
properly use PPE or when changes in the workplace, or in the PPE to be
used, render the previous training obsolete.
Additionally, EPA is proposing to require that owners and operators
subject to this rulemaking comply with provisions of 29 CFR 1910.133(b)
for requirements on selection and use of eye and face protection.
Similarly, EPA is proposing to require that owners and operators
subject to this rulemaking who would be required to administer a
respiratory protection program do so with worksite-specific procedures
and elements for required respirator use in accordance with 29 CFR
1910.134(a) through (l), except 29 CFR 1910.134(d)(1)(iii) and
(d)(3)(i)(B), for proper respirator use, maintenance, fit-testing,
medical evaluation, and training. While EPA does not propose that the
WCPP for NMP proposed for the conditions of use listed earlier in this
unit include respiratory protection requirements, EPA notes that the
proposed prescriptive controls for conditions of use listed in Unit
IV.A.4. would include respiratory protection. For respiratory PPE, EPA
is proposing that the owner or operator must ensure that all cartridges
and canisters used in the workplace are labeled and color coded with
the NIOSH approval label and that the label is not removed and remains
legible. 29 CFR 1910.134(d)(3)(iii), which EPA is proposing to cross-
reference, requires either the use of respirators with an end-of-life
service indicator certified by NIOSH for the contaminant, in this case
NMP, or implementation of a change schedule for canisters and
cartridges that ensures that they are changed before the end of their
service life. EPA is requesting comment on whether there should be a
requirement to replace cartridges or canisters after a certain number
of hours, such as the requirements found in OSHA's General Industry
Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a requirement for
a minimum service life of non-powered air-purifying respirators such as
the requirements found in OSHA's General Industry Standard for Benzene
(29 CFR 1910.1028(g)(3)(D)). Further information related to choosing
appropriate respirators, including specific examples of respirator
types, can be found in appendix F of the 2020 Risk Evaluation for NMP
(Ref. 1).
EPA proposes to require that owners and operators document in the
exposure control plan, or other documentation of the facility's safety
and health program, information relevant to respiratory program,
including records on the name, workplace address, work shift, job
classification, work area, and type of respirator worn (if any) by each
potentially exposed person, maintenance, and fit-testing, as described
in 29 CFR 1910.134(f), and training in accordance with 29 CFR
1910.132(f) and 29 CFR 1910.134(k).
EPA is soliciting comments on the non-prescriptive proposed DDCC
requirements for appropriate PPE selection, the effectiveness of PPE in
preventing direct dermal contact with NMP in the workplace. EPA
requests information on other potential dermal performance standards,
and on general absorption and permeation effects to PPE as a result of
direct contact.
In addition, EPA understands that some workplaces rinse and reuse
PPE after minimal use and is therefore soliciting comments on the
impact on effectiveness of rinsing and reusing certain types of PPE,
either gloves or protective clothing and gear. EPA also requests
comment on the degree to which additional guidance related to use of
PPE might be appropriate, including specifying PPE type or additional
standard testing specifications.
EPA is also proposing that owners and operators retain records of
the PPE that is used and program implementation. EPA proposes to
require that owners and operators document in the exposure control
plan, or other documentation of the facility's safety and health
program, information relevant to any PPE program, as applicable,
including: (A) the name, workplace address, work shift, job
classification, and work area of each person reasonably likely to
directly handle NMP or handle equipment or materials on which NMP may
present and the type of PPE selected to be worn by each of these
persons; (B) the basis for specific PPE selection (e.g., demonstration
based on permeation testing or manufacturer specifications that each
item of PPE selected provides an impervious barrier to prevent exposure
during expected duration and conditions of exposure, including the
likely combinations of chemical substances to which the PPE may be
exposed in the work area); (C) appropriately sized PPE and training on
proper application, wear, and removal of PPE, and proper care/disposal
of PPE; (D) occurrence and duration of any direct dermal contact with
NMP that occurs during any activity or malfunction at the workplace
that causes direct dermal exposures to occur and/or glove breakthrough,
and corrective actions to be taken during and immediately following
that activity or malfunction to prevent direct dermal contact to NMP;
and (E) training in accordance with 29 CFR 1910.132(f), including any
re-training. EPA may require more, less, or different documentation in
the final rule based on consideration of public comments.
d. General WCPP Requirements
i. Exposure control plan. EPA proposes to require that owners and
operators document their exposure control strategy and implementation
in an exposure control plan or through adding EPA-required information
to any existing documentation of the facility's safety and health
program developed as part of meeting OSHA requirements or other safety
and health standards. EPA proposes to require that each owner or
operator document in the exposure control plan the following:
(A) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of NMP, substitution of
NMP, engineering controls, and administrative controls to prevent or
reduce direct dermal contact with NMP in the workplace;
[[Page 51156]]
(B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(D) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training or other steps
taken;
(E) Description of any restricted area and how it is demarcated,
and identification of authorized persons; and description of when the
owner or operator expects potential direct dermal contact exposures;
(F) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(G) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes direct dermal contact with NMP
and subsequent corrective actions taken during start-up, shutdown, or
malfunctions to mitigate exposures to NMP; and
(H) Availability of the exposure control plan and associated
records for potentially exposed persons.
ii. Workplace information and training. EPA is also proposing to
require implementation of a training program in alignment with the OSHA
Hazard Communication Standard (29 CFR 1910.1200). To ensure that
potentially exposed persons in the workplace are informed of the
hazards associated with NMP exposure, EPA is proposing to require that
owners or operators of workplaces subject to the WCPP institute a
training and information program for potentially exposed persons and
assure their participation in the training and information program. As
part of the training and information program, the owner or operator
would be required to provide information and comprehensive training in
an understandable manner (i.e., plain language), considering factors
such as the skills required to perform the work activity and the
existing skill level of the staff performing the work, and in multiple
languages as appropriate (e.g., based on languages spoken by
potentially exposed persons) to potentially exposed persons. This
information and training would have to be provided prior to or at the
time of initial assignment to a job involving potential exposure to
NMP. In alignment with the OSHA Hazard Communication Standard, owners
and operators would be required to provide information and training to
all potentially exposed persons that includes (A) the requirements of
the NMP WCPP and how to access or obtain a copy of the requirements of
the WCPP; (B) the quantity, location, manner of use, release, and
storage of NMP and the specific operations in the workplace that could
result in NMP exposure; (C) principles of safe use and handling of NMP
in the workplace, including specific measures the owner or operator has
implemented to prevent direct dermal contact with NMP, such as work
practices and PPE used; (D) the methods and observations that may be
used to detect the presence or release of NMP in the workplace (such as
visual appearance or odor of NMP when being released, etc.); and (E)
the health hazards associated with exposure with NMP. In addition to
providing training at the time of initial assignment to a job involving
potential exposure to NMP, and in alignment with the OSHA General
Industry Standard for Beryllium (20 CFR 1910.1024), which includes an
annual retraining provision, owners and operators subject to the NMP
WCPP would be required to re-train each potentially exposed person
annually to ensure they understand the principles of safe use and
handling of NMP in the workplace. Owners and operators would also need
to update the training as necessary whenever there are changes in the
workplace, such as new tasks or modifications of tasks; in particular,
whenever there are changes in the workplace that increase exposure to
NMP or where potentially exposed persons' direct dermal contact
exposure to NMP can reasonably be expected to occur. In alignment with
the OSHA General Industry Standard for Methylene Chloride (29 CFR
1910.1052) owners and operators would need to retrain any exposed
person if exposure to direct dermal contact of NMP, including vapor
through skin exposure, occurs. To support compliance, EPA is proposing
that each owner or operator of a workplace subject to the WCPP would be
required to provide to the EPA, upon request, all available materials
related to workplace information and training.
iii. Workplace participation. EPA encourages owners or operators to
consult with potentially exposed persons on the development and
implementation of exposure control plans and PPE. EPA is proposing to
require owners or operators to provide potentially exposed persons, or
their designated representatives, regular access to the exposure
control plans and PPE program implementation and documentation. To
ensure compliance in workplace participation, EPA is proposing that the
owner or operator document the notice to and ability of any potentially
exposed person to NMP direct dermal contact to readily access the
exposure control plans, PPE program implementation, or any other
information relevant to NMP exposure in the workplace. EPA is
requesting comment on how owners and operators can engage with
potentially exposed persons on the development and implementation of an
exposure control plan and PPE program.
iv. Recordkeeping. To support and demonstrate compliance, EPA is
proposing that each owner or operator of a workplace subject to WCPP
retain compliance records for five years. EPA is proposing to require
records to include:
(A) the exposure control plan;
(B) PPE program implementation and documentation, including as
necessary, respiratory protection and dermal protection used and
related PPE training; and
(C) information and training provided to each person prior to or at
the time of initial assignment and any re-training.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA for examination and copying. All records required to
be maintained by this unit could be kept in the most administratively
convenient form (electronic or paper).
v. Compliance timeframes. With regard to the compliance timeframe
for those occupational conditions of use that are subject to WCPP
requirements, EPA is proposing to require that each owner or operator
of a workplace subject to WCPP establish the process outlined in this
unit within 12 months of publication of the final rule in the Federal
Register for the private sector, and within 36 months of publication of
the final rule in the Federal Register for Federal agencies and Federal
contractors acting for or on behalf of the Federal government. For the
private sector, EPA has no reasonably available information indicating
this proposed compliance date of 12 months is not practicable for WCPP
requirements, or that additional time is needed. However, EPA is
concerned about the ability of certain departments and agencies of the
Federal Government, as well as Federal contractors acting for or on
behalf of the Federal Government, to comply with these timeframes. The
importance of NMP to mission-critical Department of Defense and
National Aeronautics and Space Administration (NASA) operations and
overall military
[[Page 51157]]
readiness is discussed throughout this proposed rule, and detailed in
Unit IV.A.6. While, for example, 29 CFR 1960 sets forth procedures and
guidelines for ensuring that Federal workers are protected in
comparable ways to their private sector counterparts, EPA believes that
compliance with this proposed rulemaking would require increased and
different preparations on the part of Federal agencies. For example,
Federal agencies must follow procurement requirements which will likely
result in increased compliance timelines. In addition, these
requirements would require support in the Federal budget, which, for
some agencies, is a multi-year process. Therefore, EPA is providing an
additional two years for agencies of the Federal Government and their
contractors, when acting for or on behalf of the Federal government, to
comply with the WCPP.
EPA requests comment relative to the ability of owners or operators
in the private sector to implement such processes within 12 months of
publication of the final rule in the Federal Register, and anticipated
timelines for any procedural adjustments needed to comply with the
requirements outlined in this unit. EPA also requests comment on
whether the additional two years provided for agencies of the Federal
Government and their contractors, when acting for or on behalf of the
Federal government, to comply with the WCPP, should be provided more
broadly to all entities complying with the WCPP.
EPA may finalize significantly shorter or longer compliance
timeframes based on consideration of public comments.
4. Prescriptive Controls
a. Overview
In contrast to the proposed non-prescriptive requirements of DDCC
where regulated entities would select controls in accordance with the
hierarchy of controls to comply with the parameters outlined in this
unit, EPA is proposing that it is appropriate in certain circumstances
to require specific prescriptive controls for certain occupational
conditions of use where preventing direct dermal contact through
implementation of a WCPP or a prohibition may not be practicable. EPA's
description for how these requirements would address the unreasonable
risk and the rationale for this regulatory approach is outlined in
Units III.B.3 and V.A.
In the 2020 Risk Evaluation for NMP, and supplemental occupational
risk calculations EPA identified certain prescriptive controls, such as
product reformulation to limit concentration of NMP in certain products
that, in combination with PPE, would reduce exposures from NMP enough
to address the unreasonable risk (Ref. 37). Therefore, EPA is proposing
to require specific prescriptive controls for these occupational uses
of NMP, as described in this unit. The following requirements would
apply to the following conditions of use:
A concentration of NMP no greater than 45% in formulated
products, with requirements for appropriate dermal PPE, and any NIOSH
Approved[supreg] air-purifying respirator equipped with organic vapor
cartridges or canisters (minimum APF 10) for:
--Processing--incorporation into articles in paint additives and
coating additives in transportation equipment manufacturing;
--Industrial and commercial use in paints and coatings in lacquers,
stains, varnishes, primers and floor finishes, and powder coatings in
surface preparation;
--Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale and retail trade; and
--Industrial and commercial use in adhesives and sealants including
binding agents, single component glues and adhesives, including
lubricant adhesives and two component glues and adhesives including
some resins.
A concentration of NMP no greater than 30% in formulated
products, with requirements for appropriate dermal PPE, and any NIOSH
Approved[supreg] air-purifying respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] powered air-
purifying respirator equipped with NIOSH Approved[supreg] organic vapor
cartridges; or any NIOSH Approved[supreg] continuous flow supplied air
respirator equipped with a hood or helmet (minimum APF 25) for the
industrial and commercial use in paints, coatings, and adhesive
removers.
A concentration of NMP no greater than 5% with
requirements for appropriate dermal PPE for the industrial and
commercial use in ink, toner, and colorant products in printer ink.
A concentration of NMP no greater than 1% with
requirements for appropriate dermal PPE for the industrial and
commercial use in soldering materials.
This unit describes proposed requirements for concentration (or
weight fraction) limits, appropriate dermal PPE, and respirator types
with additional requirements proposed for recordkeeping. This unit also
describes compliance timeframes for these proposed requirements.
b. Concentration Limits for Industrial and Commercial Uses
EPA is proposing to prohibit the import, processing, distribution
in commerce, or use of the NMP-containing products for the conditions
of use listed in this unit with a concentration greater than those
listed for each condition of use. Specifically, EPA proposes that
processors, or product formulators, would not be permitted to formulate
products for the conditions of use listed in in this unit with a
concentration of NMP greater than specified in this unit. Similarly,
importers of formulated products would be prohibited from importing
products for the conditions of use listed in this unit with a
concentration of NMP greater than specified in this unit. Entities
distributing in commerce products containing NMP would be prohibited
from distributing any products for the conditions of use listed in this
unit with a concentration of NMP greater than specified in this unit.
c. Workplace Requirements
To reduce exposures in the workplace and address the unreasonable
risk of injury to health from NMP identified for the occupational uses
listed in this unit, EPA is proposing both a concentration limit
requirement and PPE requirement. Each owner or operator of a workplace
who imports, processes, or industrially and commercially uses NMP under
the conditions of use listed in this unit would be responsible for
compliance with the requirements outlined in this unit. Specifically,
concentrations of NMP in products used for the conditions of use listed
in this unit would not be permitted to exceed the listed
concentrations, and owners or operators would be responsible for
ensuring requirements for the specified PPE and PPE program laid out in
Unit IV.A.3.c. are met.
EPA is proposing to require appropriate dermal PPE, including
impermeable gloves and protective clothing, in combination with
comprehensive training for tasks with NMP. In selecting and providing
appropriate dermal PPE and providing PPE training, owners and operators
[[Page 51158]]
would be required to follow the PPE program and dermal protection
requirements laid out in Unit IV.A.3.c. Unlike DDCC, this proposed
provision would not require owners and operators to use elimination,
substitution, engineering controls, and administrative controls, prior
to relying on PPE, as a means of controlling exposures in accordance
with the hierarchy of controls. EPA encourages owners and operators to
consider the hierarchy of controls, but is only proposing to require
specific respiratory PPE for several of the conditions of use listed in
this unit, in combination with comprehensive training for tasks with
NMP. In providing the specified respirators and training, owners and
operators would be required to administer a respiratory protection
program with worksite-specific procedures and elements for required
respirator use in accordance with 29 CFR 1910.134(a) through (l),
except 29 CFR 1910.134(d)(1)(iii) and (d)(3)(i)(B), for proper
respirator use, maintenance, fit-testing, medical evaluation, and
training. EPA is proposing that the owner or operator must ensure that
all cartridges, and canisters used in the workplace are labeled and
color coded with the NIOSH approval label and that the label is not
removed and remains legible. 29 CFR 1910.134(d)(3)(iii), which EPA is
proposing to cross-reference, requires either the use of respirators
with an end-of-life service indicator certified by NIOSH for the
contaminant, in this case NMP, or implementation of a change schedule
for canisters and cartridges that ensures that they are changed before
the end of their service life. EPA is requesting comment on whether
there should be a requirement to replace cartridges or canisters after
a certain number of hours, such as the requirements found in OSHA's
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a
requirement for a minimum service life of non-powered air-purifying
respirators such as the requirements found in OSHA's General Industry
Standard for Benzene (29 CFR 1910.1028(g)(3)(D)). Owners and operators
would also be required to follow the PPE program laid out in Unit
IV.A.3.c.
d. Recordkeeping
To support and demonstrate compliance, EPA is proposing that each
owner or operator of a workplace that would be subject to the
prescriptive controls described in this unit (including product
formulators) retain compliance records for five years. EPA is proposing
to require records to include:
(1) Documentation identifying implementation of and compliance with
the concentration limits described in this unit;
(2) Dermal protection used by each potentially exposed person, as
described in this unit;
(3) Respiratory protection used by each potentially exposed person,
as described in this unit; and
(4) PPE program implementation.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA for examination and copying in accordance with EPA
requirements. All records required to be maintained by this unit could
be kept in the most administratively convenient form (electronic or
paper). EPA is requesting public comment on whether additional
documentation should be required to further support compliance and
enforceability of the proposed regulatory requirements (e.g.,
requirements for labels or SDS identifying percent of NMP within a
product, or downstream notification of these proposed requirements for
concentration limits and PPE, or other information that would be made
available to industrial and commercial users to indicate compliance
with the concentration limits).
e. Compliance Timeframes
EPA is proposing to stagger the compliance dates for the proposed
prescriptive controls described in this unit, such that the
requirements would come into effect in 12 months for importers, 15
months for processors, 18 months for distributing to retailers, 21
months for all other distributors (including retailers), 24 months for
industrial and commercial users after the publication date of the final
rule. When proposing these compliance dates as required under TSCA
section 6(d), EPA considered irreversible health effects and risks
associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be impacted, or that
additional time is needed for product reformulation and PPE training.
However, EPA requests comment on whether additional time is needed,
other concentrations are required, or if there are available
substitutes for this application. As discussed in Unit IV.A.1, EPA
recognizes that recent proposed rulemakings under TSCA section 6(a)
have received public comments requesting longer compliance timeframes.
For NMP, EPA believes that the proposed compliance timeframes for the
prescriptive controls described in this unit may present fewer
compliance challenges than those described by commenters on other
rules. For example, for NMP, it may be more feasible to more rapidly
reformulate products containing NMP or to institute workplace controls
to prevent direct dermal contact (in contrast to the challenges of
reducing inhalation exposures). EPA may finalize significantly shorter
or longer compliance timeframes based on consideration of public
comments.
5. Concentration Limits on NMP in Products for Consumer Use in
Adhesives and Sealants in Glues and Adhesives, Including Lubricant
Adhesives
In the 2020 Risk Evaluation, EPA determined that consumer use of
NMP in adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants contributes to the unreasonable risk
from NMP, due to risk of injury to health of consumers (Ref. 1). To
address the unreasonable risk to consumers, EPA is proposing to require
that import, processing, and distribution in commerce (including by
retailers) of NMP and formulated NMP-containing products intended for
consumer use in adhesives and sealants in glues and adhesives,
including lubricant adhesives and sealants be limited to a
concentration of NMP no greater than 45%.
As discussed in Units III.B.3. and V.A., based on consideration of
the severity of the hazards of NMP in conjunction with the limited
options available to address the identified unreasonable risk to
consumers under TSCA section 6(a), EPA is proposing this concentration
limit, supported by additional modeling using the methodology of the
2020 Risk Evaluation for NMP (Ref. 38). EPA is requesting public
comment on whether additional documentation should be required to
further support compliance and enforceability of the proposed
regulatory requirements (e.g., requirements for labels identifying the
percent of NMP within a product or downstream notification of these
proposed requirements for concentration limits).
Similar to the other compliance timeframes described in this unit,
EPA is proposing to stagger the compliance dates for the proposed
concentration limits described in this unit, such that the requirements
would come into effect in 12 months for importers, 15 months
[[Page 51159]]
for processors, 18 months for distributing to retailers, 21 months for
all other distributors (including retailers) after the publication date
of the final rule. When proposing these compliance dates as required
under TSCA section 6(d), EPA considered irreversible health effects and
risks associated with NMP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be impacted, or that
additional time is needed for product reformulation. However, EPA
requests comment on whether additional time is needed, other
concentrations are required, or if there are available substitutes for
this application. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.
6. Mission- or Safety-Critical Uses of NMP by DOD and NASA
a. Overview
For two conditions of use for which EPA is proposing prescriptive
controls, EPA is aware of specific mission- or safety-critical uses for
which the concentration limits EPA is proposing would negatively impact
DOD and NASA, and for which technically and economically feasible safer
alternatives that benefit health or the environment are not available.
Based on the considerations described in this unit and Unit
V.A.1.c.iii., and in accordance with TSCA section 6(c)(2), EPA is
proposing that the WCPP be allowed for use of NMP at high
concentrations by DOD, NASA, or their contractors within the following
conditions of use:
Industrial and commercial use in paints, coatings, and
adhesive removers; and
Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation.
For the reasons detailed in Unit V.A.1.c.iii., EPA is restricting
the applicability of the WCPP for industrial and commercial use of high
concentrations of NMP in paint, coating, and adhesive removal and
paints and coatings. EPA is proposing that the conditions under which
the WCPP could apply for this use would be: (1) the use of NMP for
paints and coatings at a concentration greater than 45% and for paint,
coating, and adhesive removers at a concentration greater than 30% by
DOD, NASA, or their contractor(s) performing this work only for Federal
agency projects would be limited to the mission-critical components on
government-operated aerospace vehicles, vessels, and military weapons
systems, including mission- or safety-critical components; (2) The use
of NMP for paints and coatings at a concentration greater than 45% and
for paint, coating, and adhesive removal at a concentration greater
than 30% would have to be conducted at Federal installations, at
Federal industrial facilities, or at Federal contractor facilities
performing paint or coating work, or paint, coating, or adhesive
removal work only for DOD and NASA projects; (3) any of the previously
listed Federal agencies or their contractors who use NMP in paints and
coatings at a concentration greater than 45% or for paint, coating, or
adhesive removal at a concentration greater than 30% must comply with
the WCPP requirements described in Unit IV.A.3., and (4) DOD, NASA, or
their contractors who use NMP in paints and coatings at a concentration
greater than 45%, or for paint, coating, or adhesive removal at a
concentration greater than 30% must provide a certification of their
compliance with the conditions of this use.
b. Self-Certification Requirements
To ensure that any products that exceed the concentration limits
that EPA has identified as necessary for addressing the unreasonable
risk for other industrial and commercial users do not become available
for widespread commercial use, EPA is proposing to require DOD, NASA,
or their contractors who use NMP in paints and coatings at a
concentration greater than 45%, or for paint, coating, or adhesive
removal at a concentration greater than 30% must provide a
certification of their compliance with the conditions of the
applicability of the WCPP for this use. Specifically, each entity must
provide a self-certification describing: (1) their status as either DOD
or NASA, or a contractor to DOD or NASA; and (2) their implementation
of and compliance with the WCPP to purchase and use NMP-containing
products that exceed the concentration limits for other industrial and
commercial users described in this unit.
EPA is proposing the following self-certification statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. The
facility in which this product will be used is a Federal
installation, a Federal industrial facility, or a Federal contractor
facility performing paint or coating work, or paint, coating, or
adhesive removal work for DOD and NASA projects. This facility's
implementation of the Workplace Chemical Protection Program (WCPP)
for NMP was evaluated by qualified personnel and that this facility
has implemented and complies with the WCPP for NMP. Based on my
inquiry of the person or persons who manage the facility and/or
those persons directly responsible for implementing the NMP WCPP,
and to the best of my knowledge and belief, the facility is
implementing the NMP WCPP, including the exposure control plan and
other proper documentation of the actions taken is available at the
facility upon request. I am aware that there are significant
penalties, including the possibility of civil penalties for failing
to comply with these requirements and criminal penalties, including
fines and imprisonment, for knowingly failing to comply with these
requirements. I understand that this certification shall serve as a
certification that this facility will properly implement and comply
with the WCPP for NMP consistent with the applicable regulatory
timelines.
EPA realizes that some facilities may not engage in the NMP uses
listed in this unit at the time this proposed rule is finalized. Owners
or operators that may wish to purchase NMP after publication of the
final rule would still be required to submit the self-certification
statement to the distributor from whom NMP was initially purchased to
purchase NMP, including certifying that the facility for which NMP is
being purchased will implement and comply with the WCPP. EPA is also
proposing that distributors review the self-certification statement to
ensure it is appropriately completed to include the owner or operator's
and the facility's information, as outlined in this unit. EPA is also
proposing to require distributors of NMP to retain invoices, including
the name of the facility purchasing NMP, name of the owner or operator
who is self-certifying, date of sale, and quantity of NMP purchased.
EPA is proposing that the distributors and owners or operators maintain
and retain the self-certification statement and related invoices(s) in
the most administratively convenient form (electronic or paper) and
retain the statement(s) and supporting documentation for five years.
c. Recordkeeping and Downstream Notification
EPA recognizes that for DOD, NASA, or their contractors performing
work for their projects to use paints and coatings and paint, coating,
and adhesive removers containing NMP at concentrations greater than
those proposed for other industrial and commercial use, the upstream
processing (or formulation) and distribution in commerce of those
products should also be allowed to
[[Page 51160]]
continue. For these reasons, EPA proposes that processing and
distributing in commerce NMP for paints and coatings at a concentration
greater than 45%; and for paint, coating, and adhesive removal at a
concentration greater than 30% would adhere to the following
conditions: (1) Entities processing NMP for paints and coatings at a
concentration greater than 45% or for paint, coating, and adhesive
removal at a concentration greater than 30% must comply with the WCPP
requirements described in Unit IV.A.3.; (2) Entities processing or
distributing NMP for paints and coatings at a concentration greater
than 45% or for paint, coating, and adhesive removal at a concentration
greater than 30% must provide downstream notification of the
restrictions on use of these products by adding the following language
to sections 1(c) and 15 of the SDS:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] this chemical/product cannot be
distributed in commerce to retailers for any use. After [DATE 21
MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER], this chemical/product is and can only be distributed in
commerce or processed for the following purposes: paints and
coatings or paint, coating, or adhesive removal by the Department of
Defense (DOD), the National Aeronautics and Space Administration
(NASA), or their contractors, at Federal installations, Federal
industrial facilities, or at Federal contractor facilities
performing work only for DOD and/or NASA projects.
and (3) Entities processing or distributing these products in commerce
would be required to provide a label that meets the requirements
outlined in IV.A.2. that provides similar language to the SDS:
This product contains n-methylpyrrolidone (NMP), a chemical
determined by the Environmental Protection Agency to present
unreasonable risk of injury to health under of the Section 6 of the
Toxic Substances Control Act, based on developmental and
reproductive effects. This product containing NMP is restricted for
use under 40 CFR part 751, subpart C. This product is restricted for
sale and can only be used by the Department of Defense (DOD), the
National Aeronautics and Space Administration (NASA), or their
contractors, at Federal installations, Federal industrial
facilities, or at Federal contractor facilities performing work only
for DOD and NASA projects.
These entities would be subject to the proposed general
recordkeeping requirements discussed in Unit IV.A.7., the WCPP
recordkeeping requirements discussed in Unit IV.A.3.d.iv., and
requirements to maintain records that demonstrate compliance with these
requirements.
EPA requests comments on all aspects of the proposed applicability
of the WCPP to these narrowly described uses of higher concentration
NMP in paint, coating, and adhesive removal and paints and coatings.
EPA also requests comment on whether entities other than DOD, NASA or
its contractors also require high concentration NMP and, if so, the
extent to which lack of availability of high concentration NMP could
impact their operations or pose potential challenges to the supply
chain. Finally, EPA is requesting comment on whether EPA should also
require reporting to EPA during purchasing of NMP for these specific
uses by DOD, NASA, or their contractors and if requiring reporting
could support of enforcement and compliance assurance with this
rulemaking by further assuring that distribution of these high
concentration NMP products for these uses is limited to DOD, NASA, and
their contractors, and if such requirements would impose significant
administrative burdens in addition compliance with the WCPP.
7. Other Requirements
a. Recordkeeping
In addition to the recordkeeping requirements for the WCPP and
prescriptive controls outlined in this unit, for conditions of use that
would not otherwise be prohibited under this proposed regulation, EPA
is also proposing that manufacturers, processors, distributors, and
commercial users maintain ordinary business records, such as invoices
and bills-of-lading, that demonstrate compliance with the prohibitions,
restrictions, and other provisions of this proposed regulation and
maintain such records for a period of 5 years from the date the record
is generated. EPA is proposing that this requirement begin at the
effective date of the rulemaking (60 days following publication of the
final rule in the Federal Register). Recordkeeping requirements would
ensure that owners or operators can demonstrate compliance with the
regulations if necessary. EPA may require more, less, or different
documentation in the final rule based on consideration of public
comments.
b. Downstream Notification
For conditions of use that would not otherwise be prohibited under
this proposed regulation, EPA is proposing that manufacturers
(including importers), processors, and distributors, excluding
retailers, of NMP and NMP-containing products provide downstream
notification of the prohibitions through the SDS required by OSHA under
29 CFR 1910.1200(g) by adding the following language to sections 1(c)
and 15 of the SDS:
AFTER [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], this chemical/product cannot be
distributed in commerce or processed with a concentration of NMP
greater than 0.1% by weight for the following purposes: Processing
incorporation into articles in lubricants and lubricant additives in
machinery manufacturing; Industrial and commercial use in anti-
freeze and de-icing products, automotive care products, and
lubricants and greases; Industrial and commercial use in metal
products not covered elsewhere and lubricant and lubricant additives
including hydrophilic coatings; Industrial and commercial use in
cleaning and degreasing, and cleaning and furniture care products,
including wood cleaners and gasket removers; and Industrial and
commercial uses in fertilizer and other agricultural chemical
manufacturing-processing aids and solvents.
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on NMP under TSCA and
to provide information to commercial end users about allowable uses of
NMP.
To provide adequate time to update the SDS and ensure that all
products in the supply chain include the revised SDS, EPA is proposing
a 2-month period for manufacturers and a 6-month period for processors
and distributers, excluding retailers, to implement the proposed SDS
changes following publication of the final rule.
EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
B. Primary Alternative Regulatory Action
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA
must consider and publish a statement based on reasonably available
information with respect to the reasonably ascertainable economic
consequences of the rule, including consideration of the costs and
benefits and the cost effectiveness of the proposed regulatory action
and one or more primary alternative regulatory actions considered by
the Agency. This unit includes a description of the primary alternative
regulatory action considered by the Agency. An overview of the proposed
regulatory action and alternative regulatory action for each condition
of use is in Unit IV.C.
The primary alternative regulatory action described in this
document and
[[Page 51161]]
considered by EPA combines a WCPP and prescriptive controls to address
the unreasonable risk from NMP. While in some ways it is similar to the
proposed regulatory action, the primary alternative regulatory action
described in this document differs from the proposed regulatory action
by providing for a WCPP, including DDCC, for some conditions of use
that would be prohibited or have prescriptive controls under the
proposed regulatory action. Additionally, the primary alternative
regulatory action considered includes the prohibition of one industrial
and commercial use and the manufacturing, processing, and distribution
in commerce for one consumer use, all of which would be required to
have prescriptive controls under the proposed regulatory action. The
primary alternative regulatory action would not include restrictions on
the container size of consumer products that may feasibly be used for
commercial purposes.
The primary alternative regulatory action also includes longer
compliance timeframes for implementation of WCPP and prescriptive
controls, as described in this unit. EPA requests comment on this
alternative regulatory action and whether any elements of this
alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. EPA also
requests comment on any advantages or drawbacks for the timelines
outlined in this unit compared to the timelines identified for the
proposed regulatory action in Unit IV.A.
1. WCPP
The primary alternative regulatory action described in this
document includes a WCPP, including DDCC, for the following conditions
of use:
Manufacturing (domestic manufacturing);
Manufacturing (import);
Processing as a reactant or intermediate in plastic
material and resin manufacturing and other non-incorporative
processing;
Processing incorporation into a formulation, mixture or
reaction product in multiple industrial sectors;
Processing incorporation into articles as a solvent (which
becomes part of a product formulation or mixture) including in
textiles, apparel and leather manufacturing;
Processing incorporation into articles in other sectors,
including in plastic product manufacturing;
Processing incorporation into articles in lubricants and
lubricant additives in machinery manufacturing;
Processing incorporation into articles in paint additives
and coating additives in transportation equipment manufacturing;
Processing repackaging in wholesale and retail trade;
Processing in recycling;
Disposal;
Industrial and commercial use in paints, coatings, and
adhesive removers;
Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation;
Industrial and commercial use in paint additives and
coating additives in computer and electronic product manufacturing in
electronic parts manufacturing;
Industrial and commercial use in paint additives and
coating additives in computer and electronic product manufacturing in
semiconductor manufacturing;
Industrial and commercial use in paint additives and
coating additives in construction, fabricated metal product
manufacturing, machinery manufacturing, other manufacturing, paint and
coating manufacturing, primary metal manufacturing, transportation
equipment manufacturing, wholesale and retail trade;
Industrial and commercial use as a solvent (for cleaning
or degreasing) in electrical equipment, appliance and component
manufacturing;
Industrial and commercial use as a solvent (for cleaning
or degreasing) in electrical equipment, appliance and component
manufacturing for use in semiconductor manufacturing;
Industrial and commercial use in ink, toner, and colorant
products in printer ink;
Industrial and commercial use in processing aids, specific
to petroleum production in petrochemical manufacturing in oil and gas
drilling, extraction and support activities, and in functional fluids
(close systems);
Industrial and commercial use in soldering materials;
Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases;
Industrial and commercial use in metal products not
covered elsewhere and lubricant and lubricant additives including
hydrophilic coatings;
Industrial and commercial use in laboratory chemicals;
Industrial and commercial uses in lithium ion battery
manufacturing;
Industrial and commercial use in cleaning and degreasing,
and cleaning and furniture care products, including wood cleaners and
gasket removers; and
Industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents.
As described in Unit V.A., EPA proposed prohibiting or requiring
prescriptive controls for some uses, and WCPP requirements for the
other conditions of use, because of uncertainties regarding:
(i) The feasibility of implementing workplace safety control
measures in open systems or when worker activities require manual
application or removal of NMP or NMP-containing products;
(ii) availability of alternatives; or (iii) whether the use is
ongoing or phased out. In this unit, EPA describes considerations for
the primary alternative regulatory action. EPA requests comment on the
ways in which NMP may be used in these conditions of use, including
whether activities may take place in a closed system and the degree to
which users of NMP in these sectors could successfully implement a WCPP
(including DDCC) and ancillary requirements described in Unit IV.A. EPA
is also requesting comment on whether any of the uses listed in this
unit should be prohibited instead of a WCPP, or if there are other
factors like reduced concentration limits or limited access that could
address the unreasonable risk.
Under the primary alternative regulatory action, the WCPP would
take effect 6 months later than under the proposed regulatory action.
Regulated entities would be required to implement the WCPP requirements
as described in Unit.IV.A.2. within 18 months after date of publication
of the final rule in the Federal Register. EPA requests comment on any
advantages or drawbacks for the timelines outlined in this unit
compared to the timelines identified for the proposed regulatory action
in Unit IV.A.
As noted in this unit, for some conditions of use, both the
proposed regulatory action and primary alternative regulatory action
would result in the condition of use falling under the NMP WCPP. EPA
emphasizes that for those conditions of use, the primary alternative
regulatory action includes a different timeline for implementation of
the WCPP, in comparison to the proposed regulatory action. As discussed
in more detail in Unit V.A., for those conditions of use, EPA also
considered other regulatory approaches available under TSCA section
6(a). However, EPA found that none of these other regulatory
[[Page 51162]]
approaches would address the unreasonable risk.
Where EPA has determined that a chemical substance presents
unreasonable risk under TSCA section 6(b)(4), EPA must undertake
rulemaking to ``apply one or more of the [TSCA section 6(a)(1) through
(7)] requirements to such substance . . . to the extent necessary so
that the chemical substance . . . no longer presents such risk.'' TSCA
section 6(a). ``In proposing and promulgating [such] a rule,'' EPA must
``consider and publish a statement based on reasonably available
information with respect to . . . the reasonably ascertainable economic
consequences of the rule, including consideration of . . . (II) the
costs and benefits of the proposed . . . regulatory action and of the
[one] or more primary alternative regulatory actions considered by
[EPA]; and (III) the cost effectiveness of the proposed regulatory
action and of the [one] or more primary alternative regulatory actions
considered by [EPA].'' EPA interprets this to mean that Congress
intended this ``primary alternative regulatory action'' to be another
regulatory option under TSCA section 6(a)(1) through (7) that would
meet the requirements of TSCA section 6(a) and address the unreasonable
risk identified under TSCA section 6(b)(4) ``to the extent necessary so
that the chemical substance . . . no longer presents such risk.'' Here,
the proposed regulatory action is comprised of a mix of proposed
options under TSCA section 6(a), each directed at specific conditions
of use and with specified timeframes for compliance. The primary
alternative regulatory options considered by the Agency would adjust
the overall mix of TSCA section 6(a) requirements, including compliance
timeframes, resulting in a proposed regulatory action that is more
restrictive in some ways and less restrictive in others. For conditions
of use where both the proposed option and the primary alternative
regulatory option are both variations of the NMP WCPP, the options are
distinct because implementing the WCPP on differing timetables under
TSCA section 6(d) would result in a different mix of regulatory options
with different costs, benefits, and cost effectiveness than the
proposed regulatory action.
2. Prohibition
The primary alternative regulatory action considered by EPA and
described in this document would prohibit the manufacturing,
processing, and distribution in commerce, and use for the industrial
and commercial use and prohibit the manufacture, processing, and
distribution of NMP for consumer use for the following conditions of
use:
Industrial and commercial use in adhesives and sealants
including binding agents, single component glues and adhesives,
including lubricant adhesives and two component glues and adhesives
including some resins; and
Consumer use in adhesives and sealants in glues and
adhesives, including lubricant adhesives and sealants.
As discussed in Units III.B.3. and V.A., based on consideration of
the severity of the hazards of NMP in conjunction with the limited
options available to adequately address the identified unreasonable
risk to consumers under TSCA section 6(a), EPA is proposing to address
the contributions to the unreasonable risk from the consumer use in
adhesives and sealants in glues and adhesives, including lubricant
adhesives and sealants, by prohibiting the manufacturing (including
import), processing, and distribution in commerce of NMP for this
consumer use, and upstream industrial and commercial use to remove NMP
and these products containing NMP from the market, thereby eliminating
this consumer use. The alternative regulatory action differs from the
proposed regulatory action in that, under the alternative regulatory
action, EPA would prohibit the use of NMP in the conditions of use
listed in this unit, rather than the proposed action to limit the
concentration of NMP in the formulations for these uses and require PPE
in the industrial and commercial use.
Regarding compliance timeframes, the alternative regulatory action
for a prohibition of the uses described in this unit would follow the
compliance timeframe for the proposed regulatory actions for a
prohibition. Under the alternative action, compliance dates for the
prohibition would be staggered such that the prohibitions would come
into effect in 12 months for manufacturers, 15 months for processers,
18 months for distributing to retailers, 21 months for all other
distributors (including retailers), and 24 months for industrial and
commercial users after the publication date of the final rule in the
Federal Register. With regard to the compliance timeframe for the
prohibitions on manufacturing, processing, and distribution in commerce
for consumer use, under the alternative regulatory action, prohibitions
as described in this unit would take effect in 12 months for
manufacturers, 15 months for processors, 18 months for distributing to
retailers and 21 months for all other distributors (including
retailers) after the publication date of the final rule.
C. Overview of Conditions of Use and Proposed Regulatory Action and
Alternative Regulatory Action
Table 1 presents a side-by-side summary of the proposed regulatory
action and the primary alternative regulatory action for each condition
of use. The purpose of this table is to succinctly convey to the public
the major differences between the proposed regulatory action and the
alternative regulatory action; as such the actions in each column are
truncated and do not reflect all the details of the proposed and
alternative regulatory actions, including differences in timeframes.
The proposed and alternative regulatory actions are described more
fully in Units IV.A. and B.
Table 1--Overview of Proposed Regulatory Action and Alternative
Regulatory Action by Conditions of Use
------------------------------------------------------------------------
Condition of use Action
------------------------------------------------------------------------
Primary
Subcategory Proposed alternative
regulatory action action
------------------------------------------------------------------------
Domestic manufacture............. NMP WCPP.......... NMP WCPP.
Import........................... NMP WCPP.......... NMP WCPP.
Processing as a reactant/ NMP WCPP.......... NMP WCPP.
intermediate in plastic material
and resin manufacturing and
other non-incorporative
processing.
Processing incorporation into NMP WCPP.......... NMP WCPP.
formulation, mixture or reaction
products in multiple industrial
sectors, including, but not
limited to:
Adhesives and
sealant chemicals in
adhesive manufacturing;
[[Page 51163]]
Anti-adhesive agents
in printing and related
support activities;
Paint additives and
coating additives in paint
and coating manufacturing;
and print ink manufacturing;
Processing aids not
otherwise listed in plastic
material and resin
manufacturing;
Solvents (for
cleaning or degreasing) in
non-metallic mineral product
manufacturing; machinery
manufacturing; plastic
material and resin
manufacturing; primary metal
manufacturing; soap,
cleaning compound and toilet
preparation manufacturing;
transportation equipment
manufacturing; all other
chemical product and
preparation manufacturing;
printing and related support
activities; services;
wholesale and retail trade;
Surface active
agents in soap, cleaning
compound and toilet
preparation manufacturing;
Plating agents and
surface treating agents in
fabricated metal product
manufacturing;
Solvents (which
become part of product
formulation or mixture) in
electrical equipment,
appliance and component
manufacturing; other
manufacturing; paint and
coating manufacturing; print
ink manufacturing; soap,
cleaning compound and toilet
preparation manufacturing;
transportation equipment
manufacturing; all other
chemical product and
preparation manufacturing;
printing and related support
activities; wholesale and
retail trade;
In oil and gas
drilling, extraction and
support activities; plastic
material and resin
manufacturing; services.
Processing incorporation into Prohibition....... NMP WCPP.
articles in lubricants and
lubricant additives in machinery
manufacturing.
Processing incorporation into Prescriptive NMP WCPP.
articles in paint additives and controls (45%
coating additives in CL+PPE).
transportation equipment
manufacturing.
Processing incorporation into NMP WCPP.......... NMP WCPP.
articles as a solvent (which
become part of product
formulation or mixture),
including in textiles, apparel
and leather manufacturing.
Processing incorporation into NMP WCPP.......... NMP WCPP.
articles in other sectors,
including in plastic product
manufacturing.
Processing by repackaging in NMP WCPP.......... NMP WCPP.
wholesale and retail trade.
Processing by recycling.......... NMP WCPP.......... NMP WCPP.
Industrial and commercial use in Prescriptive NMP WCPP.
paints, coatings, and other controls \1\ (30%
adhesive removers. CL+PPE).
Industrial and commercial use in Prescriptive NMP WCPP.
paints and coatings in lacquers, controls \2\ (45%
stains, varnishes, primers and CL+PPE).
floor finishes, and powder
coatings in surface preparation.
Industrial and commercial use in NMP WCPP.......... NMP WCPP.
paint additives and coating
additives in computer and
electronic product manufacturing
in electronic parts
manufacturing.
Industrial and commercial use in NMP WCPP.......... NMP WCPP.
paint additives and coating
additives in computer and
electronic product manufacturing
in semiconductor manufacturing.
Industrial and commercial use in Prescriptive NMP WCPP.
paint additives and coating controls (45%
additives in construction, CL+PPE).
fabricated metal product
manufacturing, machinery
manufacturing, other
manufacturing, paint and coating
manufacturing, primary metal
manufacturing, transportation
equipment manufacturing,
wholesale and retail trade.
Industrial and commercial use as NMP WCPP.......... NMP WCPP.
a solvent (for cleaning or
degreasing) in electrical
equipment, appliance and
component manufacturing.
Industrial and commercial use as NMP WCPP.......... NMP WCPP.
a solvent (for cleaning or
degreasing) in electrical
equipment appliance and
component manufacturing in
semiconductor manufacturing.
Industrial and commercial use in Prescriptive NMP WCPP.
ink, toner, and colorant controls (5%
products in printer ink and inks CL+PPE).
in writing equipment.
Industrial and commercial use in NMP WCPP.......... NMP WCPP.
processing aids, specific to
petroleum production in
petrochemical manufacturing, in
oil and gas drilling, extraction
and support activities, and in
functional fluids (closed
systems).
Industrial and commercial use in Prescriptive Prohibition.
adhesives and sealants including controls (45%
binding agents, single component CL+PPE).
glues and adhesives, including
lubricant adhesives and two-
component glues and adhesives
including some resins.
Industrial and commercial use in Prescriptive NMP WCPP.
soldering materials. controls (1%
CL+PPE).
Industrial and commercial use in Prohibition....... NMP WCPP.
anti-freeze and de-icing
products, automotive care
products, and lubricants and
greases.
Industrial and commercial use in Prohibition....... NMP WCPP.
metal products not covered
elsewhere, and lubricant and
lubricant additives including
hydrophilic coatings.
Industrial and commercial use in NMP WCPP.......... NMP WCPP.
laboratory chemicals.
Industrial and commercial use in NMP WCPP.......... NMP WCPP.
lithium ion battery
manufacturing.
Industrial and commercial use in Prohibition....... NMP WCPP.
cleaning and degreasing, and
cleaning and furniture care
products, including wood
cleaners and gasket removers.
[[Page 51164]]
Industrial and commercial use in Prohibition....... NMP WCPP.
fertilizer and other
agricultural chemical
manufacturing, processing aids
and solvents.
Consumer use in paint and coating 16 ounce container Would not be
removers. limit \5\ + regulated.\4\
labeling.
Consumer use in adhesive removers 16 ounce container Would not be
limit \5\ + regulated.\4\
labeling.
Consumer use in paints and 16 ounce container Would not be
coatings in lacquers, stains, limit \5\ + regulated.\4\
varnishes, primers and floor labeling.
finishes.
Consumer use in paint additives 16 ounce container Would not be
and coating additives in paints limit \5\ + regulated.\4\
and arts and crafts paints. labeling.
Consumer use in adhesives and Concentration Prohibition.\3\
sealants in glues and adhesives, Limit (45% CL)
including lubricant adhesives. \6\.
Consumer use in automotive care 16 ounce container Would not be
products. limit \5\ + regulated.\4\
labeling.
Consumer use in cleaning and 16 ounce container Would not be
furniture care products, limit \5\ + regulated.\4\
including wood cleaners and labeling.
gasket removers.
Consumer use in lubricant and 16 ounce (1 pint) Would not be
lubricant additives, including container limit regulated.\4\
hydrophilic coatings. \5\ + labeling.
Disposal......................... NMP WCPP.......... NMP WCPP.
------------------------------------------------------------------------
\1\ WCPP is the proposed regulatory action for the industrial and
commercial use in paint, coating, and adhesive removers for specific
mission- or safety-critical uses by DOD, NASA, and their contractors.
\2\ WCPP is the proposed regulatory action for the industrial and
commercial use in paints and coatings in lacquers, stains, varnishes,
primers and floor finishes, and powder coatings in surface preparation
for specific mission- or safety-critical uses by DOD, NASA, and their
contractors.
\3\ Prohibit manufacture, processing, and distribution in commerce for
the consumer use.
\4\ There is no primary alternative action for the consumer uses that do
not contribute to the unreasonable risk because similar commercial
uses would not be prohibited; rather, the primary alternative action
for the commercial uses would be WCPP.
\5\ Proposed container size restrictions are intended to prevent
diversion of consumer products to commercial users.
\6\ This is the only condition of use for consumers that contributes to
the unreasonable risk from NMP.
V. Rationale for the Proposed Regulatory Action and Alternative
Regulatory Action
This unit describes how the considerations described in Unit
III.B.3. were applied when selecting among the TSCA section 6(a)
requirements to arrive at the proposed and alternative regulatory
actions described in Unit IV.
A. Consideration of Risk Management Requirements Available Under TSCA
Section 6(a)
1. Proposed Regulatory Action
a. Prohibition
EPA considered a prohibition as a regulatory option and is
proposing it for certain conditions of use listed in Unit IV.A.1.a.
Prohibition is the preferred option for occupational conditions of use
where greater uncertainty exists relative to a sector's ability to
comply with provisions of the proposed NMP WCPP, such as DDCC
applications. This includes uncertainty regarding certain chemical
users' ability to prevent direct dermal contact with NMP, in particular
during use in open-systems or when worker activities require manual
application or removal of NMP or a product containing NMP through rags,
aerosols, spray applications, roll applicators, fingers, hands, or
other materials. For example, the processing of NMP in lubricants and
lubricant additives in machinery manufacturing includes the use of NMP
in metal finishing operations. Depending on the type of substrate being
prepared, this can include dip or immersion, spray, roll, or brush
application. While some application methods may be automated, the
extent of automated application versus use in an open sector with
handheld and manual operations is unknown. EPA has received information
from DOD about mission- or safety-critical uses of NMP at high
concentrations in hot dip-tank cleaning, and the ability of DOD and its
contractors to successfully implement the WCPP for hot dip-tank
application of NMP for cleaning and coating removal (see Unit
V.A.1.c.iii for more detail on this use). As described in Unit IV.A.6.,
EPA is proposing to require those owners and operators comply with a
WCPP rather than a prohibition. However, as described in Unit IV.A.6.,
EPA is restricting the applicability of the use of high concentrations
of NMP for paint, coating, and adhesive removal to DOD, NASA, and their
contractors due to the exposure controls that DOD, NASA, and their
contractors have in place, specifically for dip application.
While EPA has received some information from stakeholders regarding
what may be a similar use of NMP, EPA does not have sufficient
certainty that existing exposure controls by entities outside of DOD,
NASA, or their contractors could successfully apply the WCPP for high
concentrations of NMP in dip application such that the unreasonable
risk is addressed. Specifically, EPA considered information from a
stakeholder who described their use of NMP in industrial cleaning
through soaking parts directly in NMP tanks (Ref. 39). Depending on the
details of the dip application of NMP, this use may be considered
industrial and commercial use of NMP in paint, coating, or adhesive
removers; or industrial and commercial use of NMP in cleaning and
degreasing. EPA notes that the 2020 Risk Evaluation for NMP identified
three distinct occupational applications for NMP-containing cleaning
products, including aerosol degreasing, dip degreasing and cleaning
products, and wipe and spray-applied cleaning products. This
stakeholder identified engineering controls including piped fill/drain
systems, closed tank and exhaust, and other measures to reduce
potential exposure to NMP including minimum operator time at the tank,
employee training, and PPE recommended by an industrial hygienist.
While EPA believes that this type of operation could successfully
implement the NMP WCPP
[[Page 51165]]
with formulations with a high concentration of NMP, EPA has significant
uncertainty regarding the extent to which these strict workplace
controls, including prevention of direct dermal contact, are applied
during all other cleaning and degreasing dip-tank applications. EPA is
requesting comment on the workplace protection measures or exposure
reduction measures typically applied during dip application of NMP,
particularly dip degreasing and cleaning in hot or cold dip-tank
immersion cleaning and degreasing, and dip application of NMP for
adhesive, paint, or coating removal. EPA also requests comment on the
typical tasks expected during hot and cold dip cleaning or coating
removal operations, including manual or automated opening and closing
of the dip tank, cleaning and maintenance, the use of new or repurposed
vapor degreasing machines for immersion cleaning, or any other dip-tank
or immersion cleaning and degreasing activities. EPA is interested in
comments on the ability of users of high concentrations of NMP in dip
applications to successfully implement a WCPP, the availability of
alternative chemicals, and impacts of prohibiting NMP for the hot or
cold dip-tank cleaning, degreasing, or removal of adhesives, paints, or
coatings. Additionally, EPA requests comment on the number of firms who
utilize hot or cold dip NMP for cleaning, degreasing, or removal of
adhesives, paints, and coatings, the frequency of dip applications, and
size of the dip vessel. EPA also requests comment on the types of
engineering controls and any PPE use by firms who use NMP in hot or
cold dip applications.
Similarly, EPA's uncertainties include the challenges related to
PPE protection, which are discussed in more detail in Unit V.A.1.b.,
and which include how PPE may present vision problems, or cause
communication problems, worker fatigue, and reduced work efficiency (63
FR 1152, January 8, 1998) as well as consideration for that fact that
not all workers may be able to wear PPE. Prohibition is the preferred
option for occupational conditions of use where reasonably available
information suggests minimal ongoing use or when feasible safer
alternatives are reasonably available. The uncertainties related to
whether users under certain conditions of use could comply with the
requirements of an NMP WCPP, combined with the severity of the risks of
NMP, the prevalence of alternative processes and products (Unit V.B.),
and in some cases reasonably available information indicating a use is
no longer ongoing (Refs. 4, 5), has led EPA to propose prohibitions for
several industrial and commercial uses, and the upstream manufacturing
(including import), processing, and distribution in commerce for those
uses.
For example, EPA expects that for the use of NMP in fertilizers,
compliance with the WCPP would present challenges and notes that
alternatives have been identified for NMP. Therefore, EPA is proposing
to prohibit this use of NMP. EPA's proposed prohibition of this
condition of use is based on the uncertainties the agency has regarding
the full nature and extent of the exposures and variety of work
practices related to fertilizer use, and notes that the agency's
concerns that implementing the WCPP or other strict workplace controls
combined with the availability of alternatives leads to the proposed
prohibition. In the primary alternative regulatory action, EPA has
identified WCPP for this condition of use, and, as explained in more
detail in Unit V.A.2, notes that, in some cases, regulated entities may
be able to undertake more extensive risk reduction measures than EPA
currently anticipates. EPA requests comment and supporting information
on how NMP is used in the agricultural sector, including whether there
are any other application types (such as aerosol application) besides
liquid product containing NMP blended with solid fertilizer pellets.
EPA requests comment on the degree to which entities using NMP in
fertilizer manufacture or application may comply with the proposed WCPP
requirements or similar stringent workplace controls for other
conditions of use of NMP. EPA also requests comment on the workplace
safety protocols in place during application, including expected
exposure reductions during the use of NMP in fertilizer mixing and
application, current engineering controls used, PPE usage and any
standard hazard warnings or instructions in place. EPA requests comment
on its conclusion that alternatives are available for NMP in all
significant agricultural uses. Specifically, EPA requests comments on
whether there are alternatives to NMP for solvents used in the
production of fertilizers, as well as alternatives to the use of NMP to
reduce the volatility of advanced fertilizer products by keeping
nitrogen from volatilizing into the atmosphere before it can be
absorbed into the soil. EPA also requests comment regarding the number
of businesses and other entities that could potentially close as well
as associated costs with a prohibition of NMP for the industrial and
commercial conditions of use identified in Unit IV.A.1.a.
EPA determined prohibition would not be suitable for the remaining
occupational conditions of use, such as processing as a reactant or
intermediate in plastic material and resin manufacturing and other non-
incorporative processing and several types of processing incorporation
into a formulation, mixture, or reaction product; and industrial and
commercial uses as a paint and coating additives in multiple
applications or as a solvent, particularly for electronic component
manufacturing applications, as a processing aid in petrochemical
manufacturing, and as a laboratory chemical. EPA made this
determination based on compelling reasons to not prohibit the activity
and identification of a regulatory approach that would address the
unreasonable risk. For example, prohibition may not be suitable for
conditions of use that may have critical or essential uses for which no
technologically and economically feasible safer alternative is
available, or where EPA identified strict workplace controls could be
implemented for these uses to address the unreasonable risk, as
described in Unit IV.A.3.
Additionally, prohibition may not be suitable for conditions of use
where alternative substances to NMP are at least as hazardous, in
particular for other solvents undergoing risk evaluation and risk
management under TSCA section 6. For example, methylene chloride is
also in risk management under TSCA section 6 and has been determined to
present unreasonable risk of injury to health. For industrial and
commercial use in laboratory chemicals, NMP and methylene chloride are
both used as a solvent although they are not drop-in substitutes for
each other. In selecting among the TSCA section 6(a) requirements for
the proposed approach for the use in laboratory chemicals, EPA
considered whether technically and economically feasible alternatives
that benefit health or the environment will be reasonably available as
a substitute.
Given the severity of the risks identified in the 2020 Risk
Evaluation for NMP, EPA proposes that prohibiting manufacture
(including import), processing, and distribution in commerce of NMP for
the industrial and commercial uses listed in Unit IV.A.1.a. is
reasonable and necessary to eliminate the unreasonable risk of NMP.
To support implementation of the proposed prohibitions and
restrictions, EPA also considered, and is proposing,
[[Page 51166]]
a de minimis level for products containing NMP to account for
impurities that do not contribute to the unreasonable risk. EPA
recognizes that the ability to test whether a product or entity would
be regulated or not, by using a de minimis level, is beneficial and
valuable to the regulated community.
EPA recognizes the importance of the OSHA Hazard Communication
Standard (29 CFR 1910.1200), which sets a 0.1% de minimis level for
chemicals that are carcinogens, and a limitation of 1% for chemicals
that are not carcinogenic. As a matter of risk management policy, EPA
believes that the widespread awareness by industrial and commercial
workplaces of the de minimis levels in the OSHA Hazard Communication
Standard would generally support successful implementation of the level
EPA has identified. EPA notes that while NMP is not carcinogenic, EPA
considered that it is identified as a substance of very high concern by
the European Chemicals Agency and that Article 33(1) of the REACH
Regulation details that businesses are only required to report when
their products contain substances of very high concern that exceed 0.1%
(Ref. 40). While NMP is not carcinogenic, this indicates a need for a
de minimis level for NMP that would be lower than 1% under the OSHA
Hazard Communication Standard.
EPA conducted an analysis using the methodology in the 2020 Risk
Evaluation for NMP to estimate whether there is a weight fraction of
NMP in products below which the most conservative use, applied through
chronic application at the high-end exposure estimate of those
products, respectively, and at various air concentrations would not
contribute to the unreasonable risk from NMP (Ref. 41). EPA examined
the supplemental analysis and found that an NMP concentration of 0.1%
would achieve exposure concentrations that do not contribute to
unreasonable risk up to an air concentration of 30 mg/m3. EPA also
recognizes that an NMP concentration of 0.1% or less is likely to
indicate an unintentional impurity in a product rather than a
functional ingredient.
Based on these analyses, and to be protective of human health while
also aligning with national and international regulations, EPA is
proposing a de minimis level of 0.1%. As a result, EPA is proposing to
exclude from prohibition and restrictions products containing NMP at or
less than 0.1% by weight, as described in Unit IV.A. EPA has identified
uncertainties with a concentration limit of 0.1% addressing the
unreasonable risk. For example, the expected air concentration (as a
time weighted average) may less accurately estimate inhalation
exposures from some applications where exposures may differ from those
predicted by the model (e.g., as a result of higher NMP application
rate or decreased ventilation). However, a concentration limit of 0.1%
provides a margin of error to account for the uncertainties associated
with the exposure model. EPA is requesting comment on the de minimis
concentration limit of NMP in products or formulations. EPA emphasizes
the agency's interest in aligning to the extent possible with the de
minimis thresholds in the OSHA Hazard Communication Standard, while
also noting that additional analytical work was conducted for NMP. EPA
requests comment on whether de minimis thresholds should be proposed
consistent with national and international regulations, or whether
there may be instances where chemical-specific analyses is appropriate.
Details of the proposed prohibitions and restrictions are described in
more detail in Unit IV.A.
b. Container Size Restrictions
Some products in the Chemical Use Report were identified as
intended for both commercial and consumer use. The 2020 Risk Evaluation
for NMP incorporated these products into the occupational and consumer
exposure scenarios, and EPA has determined that the industrial and
commercial use contributes to the unreasonable risk for NMP due to
worker exposure, while the consumer use of similar products does not
contribute to the unreasonable risk (Ref. 1). In the 2020 Risk
Evaluation for NMP, EPA considered currently available consumer
products and their expected applications and evaluated exposures for
consumers based on completion of a single project on a given day. EPA
requests comment on if there are any NMP-containing consumer products
that may require a more frequent or multiple day application, and if
so, should EPA require additional restrictions for consumer products.
While EPA is not proposing to regulate the manufacture, processing,
or distribution in commerce of these consumer products to address risks
from the consumer use of such products, these consumer products are
similar in composition and purpose to the commercial products that EPA
does propose to prohibit and restrict. Therefore, EPA is also proposing
regulations to prevent the consumer products that will remain available
in the market from being diverted for commercial purposes. To reduce
the potential of commercial users (e.g., workers) accessing NMP-
containing consumer products for use in any commercial conditions of
use, EPA is proposing to prohibit importing, processing (e.g.,
repackaging) and distribution--including to and by retailers--of NMP
and NMP-containing products in containers larger than 16 ounces for the
uses listed in Unit IV.A.2. EPA believes that limiting containers to
typical consumer product sizes that would be inefficient for commercial
use would prevent commercial purchase and use of these products.
Consumer use is expected to result in acute exposures from a one-time
use (resulting only in acute exposure and effects), while commercial
use is expected to include repeated exposure from frequent use
(resulting in acute and chronic exposure and effects). EPA believes
that commercial users would be dissuaded from using consumer products
if the container sizes are limited. Instead, potential commercial users
would more likely select an alternative product, since it would be
impractical to purchase the large number of smaller containers
necessary for commercial use. EPA requests comment on the potential
impacts to consumers and the consumer use of these products from a
container size requirement.
EPA is also requesting comment on whether, rather than a container
size restriction requirement, a maximum concentration limit for
products containing NMP be required instead. EPA is aware of a range of
concentrations of NMP in consumer products on the market (Ref. 1). If
products in this range of concentrations of NMP were used in an
occupational setting, they would contribute to the unreasonable risk
from NMP (Ref. 2). EPA requests comment on the typical or effective
concentration of NMP in the following consumer products: paint and
coating removers, adhesive removers, paints and coatings, paint
additives and coating additives in arts and crafts paint, automotive
care products, cleaning and furniture care products, and lubricant and
lubricant additives, and whether a maximum concentration of NMP could
be identified that would allow the product to continue to be
efficacious for consumer use, but that would not exceed the
concentrations EPA has identified in Unit IV.A.1.e. for addressing the
contribution of these types of products to unreasonable risk for
workers.
[[Page 51167]]
c. WCPP
Regarding industrial, commercial, and consumer uses of NMP, TSCA
section 6(a)(2) provides EPA with the authority to prohibit or
otherwise restrict the manufacture (including import), processing, or
distribution in commerce of a substance or mixture ``for a particular
use'' to ensure that a chemical substance no longer presents
unreasonable risk. For this rule, EPA proposes that ``for a particular
use'' includes industrial, commercial, and consumer uses more broadly,
which encompasses all known, intended, and reasonably foreseen uses of
NMP. Given the severity and ubiquitous nature of the risks identified
in the 2020 Risk Evaluation for NMP for all industrial and commercial
uses evaluated, and noting that those conditions of use evaluated in
the Risk Evaluation encompass all known, intended, and reasonably
foreseen uses of NMP, EPA proposes establishing requirements for an NMP
WCPP for all occupational conditions of use except for those conditions
of use which would be prohibited or subject to prescriptive controls.
An NMP WCPP would include a combination of requirements to the extent
necessary to address unreasonable risk driven by direct dermal
exposures in the workplace. An NMP WCPP would encompass restrictions
all occupational conditions of use except those which would be
prohibited or subject to prescriptive controls, and could include
provisions for a DDCC, and ancillary requirements to support
implementation of these restrictions. While the NMP WCPP includes
stringent requirements that would be necessary to address the
unreasonable risk from NMP, EPA identified a relatively large number of
conditions of use where the Agency expected, based on reasonably
available information, an NMP WCPP could be successfully implemented
because the dermal exposures can be more effectively controlled across
this broad range of facilities engaging in a relatively large number of
conditions of use.
i. DDCC requirements. For occupational conditions of use not
otherwise proposed to be prohibited or subject to prescriptive
controls, including but not limited to those listed in Unit IV.A.3.,
EPA considered including a requirement for DDCC in the NMP WCPP. DDCC,
under the NMP WCPP, would be a process-based requirement to prevent
direct dermal contact in the workplace by separating, distancing,
physically removing, or isolating potentially exposed persons from
direct handling of NMP or from contact with equipment or materials on
which NMP may exist under routine conditions. DDCC is non-prescriptive,
in the sense that it would not require a specific control to prevent
direct dermal contact. Rather, DDCC would enable regulated entities to
determine how to most effectively separate, distance, physically
remove, or isolate potentially exposed persons from direct dermal
contact with NMP based on what works best for their workplace, in
accordance with the hierarchy of controls. In deciding whether DDCC
would appropriately address the unreasonable risk driven by dermal
exposures, EPA considered factors related to work activities that may
make it difficult to eliminate direct dermal contact. Examples include
work activities that may take place in open systems that require manual
handling of NMP, such as application or removal of NMP or an NMP-
containing product through rags, aerosols, spray guns, roll
applicators, fingers, hands, or other materials or work activities that
require a high range of motion or for some other reason create
challenges for the implementation of dermal PPE.
EPA also considered whether exposures could be reduced in a manner
aligned with the hierarchy of controls and considered the type of PPE
that would be needed under the NMP WCPP to prevent direct dermal
contact if elimination, substitution, engineering controls, and
administrative controls are not sufficient to prevent direct dermal
contact. The 2020 Risk Evaluation for NMP describes expected exposures
with and without use of PPE; even if chemically resistant gloves are
used in combination with basic workplace training and specific activity
training for tasks where dermal exposure can be expected to occur, EPA
found that dermal exposures would continue to pose risk concerns for
most conditions of use. However, the 2020 Risk Evaluation for NMP
identifies several uncertainties regarding the dermal exposures
modeled. For example, the 2020 Risk Evaluation for NMP does not
consider the frequency, type, and effectiveness of gloves or other
types of PPE used or specific workplaces. In addition, the 2020 Risk
Evaluation for NMP does not specify the specific activity training
beyond procedure for glove removal and disposal (Ref. 1).
In consideration of the 2020 Risk Evaluation for NMP, including the
uncertainties, EPA has preliminarily determined that preventing direct
dermal contact to NMP through DDCC requirements, including requirements
to reduce exposures in a manner aligned with the hierarchy of controls,
workplace specific training, and, if necessary, dermal PPE which covers
any exposed skin (including hands, legs, torso, and face), and PPE
training, as described in Unit IV.A.3., for certain occupational
conditions of use would address the contributions to unreasonable risk
from dermal exposures from these conditions of use for potentially
exposed persons.
ii. NMP WCPP. Taking into account these considerations, EPA is
proposing that occupational conditions of use other than those proposed
to be prohibited or subject to prescriptive controls (as listed in
Units IV.A.1 and 4), including those listed in Unit IV.A.3., would be
allowed to continue if regulated entities could ensure direct dermal
contact is prevented, and other requirements are met in the NMP WCPP.
In contrast to considerations indicating that it is unlikely that
facilities within a condition of use could successfully implement WCPP,
there are certain considerations that indicate that facilities engaging
in a condition of use would likely be able to achieve effective risk
management via WCPP. Based on reasonably available information,
including monitoring data (Ref. 42), process descriptions, and
information related to considerations described previously in this
unit, EPA's confidence that requirements to prevent direct dermal
contact can be implemented is highest in highly standardized and
industrialized settings, such as where NMP is used in a closed system.
For example, one of the conditions of use for which EPA is proposing a
WCPP is processing of NMP as a reactant or intermediate in plastic and
resin manufacturing and other non-incorporative processing. NMP use and
exposure information submitted by industry indicates that controls may
already be in place at some workplaces to prevent or reduce direct
dermal contact with NMP, including enclosed transfer liquid lines,
processing equipment, other engineering and administrative controls,
and chemically resistant gloves (Ref. 43).
Another set of conditions of use for which EPA is proposing the
WCPP is the industrial and commercial use of NMP in paint additives and
coating additives and as a solvent (for cleaning or degreasing) in
computer and electronic product manufacturing in semiconductor
manufacturing and the industrial and commercial use of NMP in lithium
ion battery manufacturing. EPA understands that most workplaces using
NMP in semiconductor manufacturing and lithium ion battery
manufacturing already have stringent
[[Page 51168]]
controls in place that reduce workplace exposures. As described in
public comments and through engagement with the Semiconductor Industry
Association (SIA), the Lithium Ion Cell Manufacturers' Coalition
(LICMC), and individual companies, these manufacturing facilities use
NMP in frequent, closed processes, where it does not present
opportunity for human exposure and where NMP is completely removed from
the final product (Refs. 42, 44). Semiconductor manufacturing
stakeholders have described how, upon delivery by tote or tank truck at
refineries, NMP is directly injected from a tote into a closed
processing unit or transferred from a truck into a storage tank that is
directly hooked up for direct injection in a closed system. Transfer
procedures of NMP are performed pursuant to comprehensive written
procedures under strict PPE guidelines including, when appropriate,
respirators. Information submitted by SIA indicates that worker
exposure is limited to chemical unloading and transfer procedures (Ref.
42). Information submitted by LICMC indicates that their members
manufacturing facilities use engineering controls like automatic
mixers, closed system piping and ventilation, and where direct contact
with NMP is possible workers are provided powered air purifying
respirators (APF 1000) with particulate/organic vapor cartridge, and
NMP resistant gloves and boots, and other PPE as necessary including
Tyvek suits, face shields, splash goggles, and latex inner gloves (Ref.
44).
While EPA understands that it is likely that the frequency and
duration of exposure to NMP at semiconductor manufacturing facilities
may be less than what was assumed in the risk evaluation, as described
in this unit, EPA does not have any dermal monitoring data to confirm
that NMP exposures are below the level modeled in the 2020 Risk
Evaluation. Based on analysis in the 2020 Risk Evaluation for NMP
describing expected exposures with and without use of PPE, EPA
identified that even with direct dermal contact, PPE would not be
sufficient to mitigate the unreasonable risk driven by dermal exposure
from this condition of use. However, based on information received for
this condition of use and reasonably available information, EPA
believes that controls may already be in place to prevent or reduce
direct dermal contact with NMP, such as using NMP in a closed system to
limit exposures and implementing comprehensive written procedures with
added PPE during transfer procedures.
For both of these conditions of use (processing as a reactant or
intermediate in plastic and resin manufacturing and other non-
incorporative processing and industrial and commercial use in
semiconductor manufacturing), in the 2022 revised risk determination,
EPA determined that exposures to workers drove the unreasonable risk,
but exposures to ONUs did not. ONUs include supervisors, managers, and
other employees that may be in the production areas but do not perform
tasks that result in direct dermal contact with liquids. Additionally,
the risk calculation results between worker unreasonable risk and ONU
no unreasonable risk were significantly different. This suggests that,
for these conditions of use, owners or operators must prevent direct
dermal exposure to address the unreasonable risk, even though ONUs are
not expected to be at the exposure source like workers. This
information, together with other considerations previously described
indicating stringent controls may already be in place, adds to EPA's
confidence that facilities engaging in these two conditions of use
could meet, and may in fact already be meeting, the WCPP requirements.
For NMP to be available for the downstream industrial and
commercial uses that would continue under an NMP WCPP, it would need to
be manufactured (including imported), processed, and distributed in
commerce. Likewise, as long as NMP remains in use, it must also be
disposed of. Therefore, EPA is proposing requirements to meet an NMP
WCPP for manufacture (including import), certain processing conditions
of use, and disposal, to allow for a continued supply chain for
specified conditions of use while ensuring that workers are not subject
to unreasonable risk from NMP as it moves throughout the supply chain.
Details of the proposed NMP WCPP, including DDCC, required
implementation measures, requirements for demonstrating compliance and
requirements for distributors, are described in more detail in Unit
IV.A.3.
iii. Mission- or safety-critical uses of NMP by DOD and NASA. As
described earlier in Unit IV.A.6., EPA is aware of specific mission- or
safety-critical uses for which the concentration limits EPA is
proposing would negatively impact DOD and NASA. EPA is proposing that
the WCPP be allowed for use of NMP at high concentrations by DOD, NASA,
or their contractors within two conditions of use. DOD and NASA have
identified mission-critical uses for NMP in paints, coatings, and
adhesive removal as well as in paints and coatings for ensuring
readiness of aviation, including human-rated space vehicle hardware,
and military vessels (Refs. 45). Based on reasonably available
information to EPA, there are no technically and economically feasible
alternatives to these products with high concentrations of NMP that
benefit health or the environment. These uses are important to the
military readiness of DOD's warfighting capability and the
functionality paramount to ensuring national security. These uses are
also important to NASA's space projects. Based on the existence of the
current exposure reduction methods and EPA's expectation that DOD,
NASA, and their contractors can comply with the WCPP for NMP in a way
that addresses unreasonable risk, EPA is proposing WCPP with narrow
applicability for these uses.
Regarding paint, coating, and adhesive removal, DOD has identified
no alternatives for the use of products containing high concentrations
of NMP for the removal of coatings from mission-critical corrosion-
sensitive components on military aviation and vessels, including
mission- or safety-critical components made of specialty metallic,
nonmetallic, and composite materials. Similarly, NASA has identified
mission-critical NMP-containing products that are integral to de-
processing and necessary for removing a variety of coatings from
various flight hardware and avionic components, without which mission
risk would be increased. For both DOD and NASA, the NMP-containing
products used are higher than the 30% concentration limits EPA is
proposing as part of the prescriptive controls described in Unit
IV.A.4. EPA has identified products for this use containing up to 70%
NMP (Ref. 1) and DOD and NASA may use pure (neat) NMP for their
mission-critical processes. Additionally, NMP has been used to meet
required levels of performance of certified component parts by long-
standing design and function specifications that are incorporated into
contracts of a complex supply chain.
While EPA is not proposing to prohibit the industrial and
commercial use of NMP for removal of paints, coatings, and adhesives,
EPA is proposing to limit the concentration of NMP in those products to
no more than 30% as described in Unit IV.A.4. This would result in
impacts to aircraft and military vessels for military missions and
space exploration. A concentration of 30% NMP may not be effective
enough or capable of removing paints,
[[Page 51169]]
coatings, or adhesives on specialized equipment or parts. In many
instances, only a highly concentrated amount of NMP would be capable of
successfully performing this function. As an example, NMP and products
containing a high concentration of NMP are used to break down and
remove materials such as cured epoxies and thermoset resins from
components that would be damaged by other means. This type of operation
is conducted to refurbish and reuse delicate electronic components and,
more critically, to deconstruct failed hardware to allow examination
for root cause analysis. Failure analysis must be conducted to collect
data needed to determine potential risks to hardware that relies on the
failed component and to inform vehicle architecture and hardware design
efforts. Information available to EPA indicates that, for NASA, using
NMP often is the only way to break down these materials without also
damaging the substrate used by NASA. EPA is not aware of similar uses
of such high concentration of NMP by entities outside the Federal
government.
DOD and NASA have described the equipment they use for the coating
removal application, and the differences between their coating removal
operations and the brush-on or pour-over methods used for coating
removal through other commercial or consumer products. DOD has
described how the temperature, pH, and other constituents of the
solution used in what is described as a hot dip-tank create hazards,
separate from NMP, which are managed in DOD or contractor facilities
through separation and dedicated ventilation of the tanks (and,
secondarily, worker PPE). Based on the existence of the current
exposure reduction methods and EPA's expectation that DOD, NASA, and
their contractors can comply with the WCPP for NMP in a way that
addresses unreasonable risk, EPA is proposing WCPP with narrow
applicability for these uses. Information available to EPA does not
indicate that commercial users other than DOD or NASA use such high
concentrations of NMP, or that they have a need for similar paints or
coatings. By requiring prescriptive controls that provide for a
concentration of NMP that includes one currently found on the market
along with implementable work practices, EPA believes that use of NMP
in paint and coating applications in commercial aviation, space travel,
or uses similar to those described by DOD and NASA could continue
without resulting in unreasonable risk.
Similarly, regarding paints and coatings, DOD and NASA have
identified mission-critical items using products containing high
concentrations of NMP in specialized coatings for military tactical
equipment on military aviation and vessels and development and
maintenance of component parts, including human-rated space vehicle
hardware. For both DOD and NASA, the NMP-containing products used are
higher than the 45% concentration limit EPA is proposing as part of the
prescriptive controls described in Unit IV.A.4. One such coating is a
polyimide coating used in fabrication of detectors to meet precise
specifications for use by Federal Agencies in systems such as
spacecraft, aircraft, balloons, rockets, and telescopes. This coating,
which is 60% NMP, is critical to fabricating these detectors.
Additionally, NMP has been used to meet required levels of performance
of certified component parts by long-standing design and function
specifications that are incorporated into contracts of a complex supply
chain. While EPA is not proposing to prohibit the industrial and
commercial use of NMP for paints and coatings, EPA is proposing to
limit the concentration of NMP in these products to no more than 45%,
as described in Unit IV.A.4. This may result in a coating ineffective
for the specialized parts or processes used by DOD and NASA. In many
instances only a higher concentration of NMP would be capable of
successfully performing the necessary function. Additionally,
information available to EPA indicates that application of these
coatings typically includes very small quantities (less than 1 pound
annually) under tightly controlled conditions, allowing for successful
application of the WCPP and greater certainty that the unreasonable
risk can be addressed in comparison to other situations in which
coatings containing NMP may be applied. For these reasons, EPA is
proposing WCPP with narrow applicability for these uses. As described
earlier in this unit for paints and coatings, information available to
EPA does not indicate that commercial users other than DOD or NASA use
such high concentrations of NMP for paint, coating, or adhesive removal
in these types of uses. By requiring prescriptive control that provides
for a concentration of NMP that includes one currently found on the
market along with implementable work practices, EPA believes that use
of NMP in paint, coating, and adhesive removal in commercial aviation,
space travel, or uses similar to those described by DOD and NASA could
continue without resulting in unreasonable risk.
In the narrowly described uses by DOD and NASA for mission- and
safety-critical uses, in the controlled environments operated by those
agencies or their contractors, EPA expects it is possible for the
unreasonable risk to be addressed by the WCPP. However, EPA does not
have information to support that expectation for other commercial users
of these products, including by entities other than DOD or NASA engaged
in commercial aviation or space travel. To prevent widespread
distribution of the products containing high concentration of NMP
beyond DOD, NASA, and their contractors, EPA is proposing additional
requirements, including self-certification, downstream notification,
and recordkeeping. These requirements are detailed in Unit IV and would
not significantly burden the entities processing, distributing, or
using NMP for these highly specialized uses, while providing important
enforcement and compliance tools. EPA is seeking comment on whether the
WCPP, with no concentration limits, should apply to all users of NMP in
paints and coatings, and paint, coating and adhesive removal, rather
than narrowly to DOD and NASA.
d. Prescriptive Controls
Another requirement EPA considered to address unreasonable risk for
occupational conditions of use was requiring specific controls
prescribed by EPA, including concentration limits and PPE. In the 2020
Risk Evaluation for NMP, EPA identified that certain workplace controls
could reduce exposures (Ref. 1). The prescriptive controls EPA
considered (such as concentration limits and PPE) are based on
information in the 2020 Risk Evaluation for NMP and supplemental
analyses using methodology from the 2020 Risk Evaluation for NMP. In
general, EPA does not prefer prescriptive controls as the primary
method of risk management because of uncertainties about whether the
prescriptive controls will be feasible for reducing exposures in all
workplaces engaged in a condition of use and whether the prescriptive
controls will be consistently or properly used. EPA understands that
workplaces have unique processes and equipment in place and that
varying levels of respiratory protection or dermal PPE may be needed
for different workplaces. Additionally, as described in Unit III.A.1.
and 2., EPA received input during required consultations and additional
engagement that options that align with the hierarchy of controls
(i.e., elimination and substitution of hazards
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in the workplace) should be preferred over prescriptive controls.
EPA also determined that certain prescriptive controls (i.e., PPE)
may not be able to eliminate unreasonable risk contributed by some
conditions of use when used in isolation. In the 2020 Risk Evaluation
for NMP, analysis of occupational exposure scenarios indicated that
many conditions of use still posed risk concerns even with the
application of PPE (Ref. 1). Because of the uncertainty regarding the
feasibility of exposure reductions through engineering controls alone,
EPA determined that an NMP WCPP, which would be accompanied in tandem
with the implementation of engineering controls, administrative
controls, and/or PPE as elements of the program, as appropriate, would
more successfully reduce exposure so that the unreasonable risk is
addressed. Additionally, relying primarily on PPE to reduce exposures
does not consider other more protective controls in the hierarchy,
including elimination, substitution, engineering controls, and
administrative controls. For occupational conditions of use where
compliance with the NMP WCPP is unlikely to be successful, in most
cases prohibitions (rather than prescribed controls) would be more
appropriate to ensure that NMP does not present unreasonable risk under
the conditions of use.
However, based on the 2020 Risk Evaluation for NMP, EPA considered
the industrial and commercial use in the uses listed in Unit IV.A.4.a.
as viable candidates for prescriptive controls. These uses include the
application of NMP-containing products that have been identified in a
range of concentrations of NMP rather than requiring the use of pure
NMP, and include application, such as brush or roll tasks where direct
dermal contact may not be preventable. Therefore, EPA conducted
additional analyses with the model used in the 2020 Risk Evaluation
within the ranges identified for the NMP-containing products with and
without PPE and determined the parameters required to address the
unreasonable risk.
For the industrial and commercial use of NMP in ink, toner, and
colorant products, and in soldering materials, EPA did not conduct
additional modeling and used information in the 2020 Risk Evaluation
for NMP. EPA modeled a range of expected concentration limits, as
described in section 2.4 of the 2020 Risk Evaluation for NMP. When EPA
modeled the lower bound of identified concentration of NMP in
formulation at the central tendency without PPE, it did not contribute
to the unreasonable risk to workers. Alternatively, when EPA modeled at
the upper bound of identified concentration of NMP at the high-end
without PPE it did contribute to the unreasonable risk to workers, but
dermal PPE could mitigate the unreasonable risk to workers (Ref. 1).
Therefore, EPA is proposing the lower bound concentration limit and
dermal PPE to address the unreasonable risk and prevent product
formulation with high concentration limits that were not assessed in
the 2020 Risk Evaluation for NMP and could potentially contribute to
the unreasonable risk.
For additional conditions of use, EPA's analysis in the 2020 Risk
Evaluation for NMP indicated that for the uses identified in Unit
IV.A.4.a. (not including the conditions of use ink, toner, and colorant
products, and in soldering materials) there would still be risk
concerns even if chemically resistant gloves are used in combination
with specific activity training for tasks where dermal exposure can be
expected to occur. However, as described earlier, the 2020 Risk
Evaluation for NMP identifies several uncertainties regarding the use
of the dermal exposures modeled. For example, the 2020 Risk Evaluation
for NMP does not consider the frequency, type, and effectiveness of
gloves or other types of PPE used in these specific conditions of use
(Ref. 1). In consideration of the whole of the 2020 Risk Evaluation for
NMP, including these uncertainties and EPA's supplemental risk
calculations, EPA identified certain exposure controls, such as limits
on the concentration of NMP in certain products in combination with
requirements for specified respirators and appropriate dermal PPE use,
that would reduce exposures to NMP enough to address the unreasonable
risk (Ref. 37). For these specific conditions of use, where expected
activities like spray, brush, or roll applications of NMP-containing
products results in higher air concentration levels than those
conditions of use listed in Unit IV.A.3., dermal PPE alone is not
expected to address the unreasonable risk. In the supplemental risk
calculations EPA evaluated whether dermal PPE alone, or in combination
with respirators, either APF 10 or APF 25 would address the
unreasonable risk and determined that the combination of the set
concentration limits and specified inhalation and dermal PPE listed in
Unit IV.A.4. would address the unreasonable risk. EPA is requesting
comment on whether there are additional circumstances where specific
PPE (including respirators) should be prescribed, as well as the
appropriateness of the proposed respiratory protection requirements for
these conditions of use as listed in Unit IV.A.4 and any impacts that
the prescriptive use of respiratory protection may have on workplace
operations.
EPA recognizes that these different conditions of use have
different expected activities or application methods, such as spray
application of a paint remover that results in a higher-than-average
air concentration of NMP as compared to the roll-on application of ink
that does not result in elevated air concentration of NMP. As a result,
EPA is proposing four different combinations of concentration and PPE
to account for the specific exposures expected while also allowing each
of the conditions of use to remain efficacious.
EPA has preliminarily determined that preventing direct dermal
contact with NMP through dermal PPE that covers any exposed skin and
PPE training for the industrial and commercial uses listed in Unit
IV.A.4. in combination with the proposed concentration limits would
address the unreasonable risk from dermal exposure driven by these
conditions of use for potentially exposed persons. EPA is requesting
comment on whether preventing dermal contact with NMP through dermal
PPE, training, and a concentration limit would adequately address the
unreasonable risk from dermal exposures for these industrial and
commercial use. For certain occupational conditions of use, prescribed
engineering controls, administrative controls, and PPE were considered
as part of the alternative regulatory action and are described in more
detail later in this unit and in Unit IV.B.
e. Concentration Limit for Consumer Use in Adhesives and Sealants
EPA's approach for the consumer use of NMP in adhesives and
sealants in glues and adhesives is similar to the prescriptive controls
approach for certain occupational conditions of use, described earlier
in this unit. For the consumer use listed in Unit IV.A.5., EPA proposes
to allow the import, processing, and distribution in commerce of NMP
for the consumer use of NMP in adhesives and sealants in glues and
adhesives, including lubricant adhesives and sealants only in a
concentration of up to 45% in formulated products for consumer use. In
the 2020 Risk Evaluation for NMP, EPA identified certain product
concentration limits for this consumer
[[Page 51171]]
condition of use, based on information in the 2020 Risk Evaluation for
NMP and supplemental analyses using methodology from the 2020 Risk
Evaluation for NMP. EPA understands that consumers have unique
processes and are not expected to have exposure reduction equipment in
place or consistently use any levels of respiratory protection or
dermal PPE. Therefore, EPA calculated a concentration limit that did
not present unreasonable risk even without the use of PPE.
2. Alternative Regulatory Actions
EPA acknowledges that, for some of the occupational conditions of
use that it is proposing to prohibit or require strict workplace
controls, there may be some activities or facilities that could
conceivably implement requirements under the NMP WCPP to prevent direct
dermal contact with NMP. In some cases, they may be able to undertake
more extensive risk reduction measures than EPA currently anticipates.
Therefore, as a primary alternative regulatory action, described in
Unit IV.B., EPA is considering and requesting comment on an NMP WCPP--
including requirements to prevent direct dermal contact--for some
conditions of use of NMP that would be prohibited or otherwise
regulated under the proposed regulatory action. For those conditions of
use that would be subject to the NMP WCPP under the alternative
regulatory action, but not the proposed regulatory action, EPA was not
able to identify reasonably available information such as monitoring
data or detailed activity descriptions to indicate with certainty that
relevant regulated entities for these conditions of use could mitigate
identified unreasonable risk through an NMP WCPP. Due to this
uncertainty, EPA is requesting comment on the alternative regulatory
action and in particular the likelihood of successful compliance with
an NMP WCPP, as described in Unit IV.A., for the conditions of use
listed for the alternative regulatory action of NMP WCPP in Unit IV.B.
EPA notes that the primary alternative regulatory action includes WCPP
for additional commercial conditions of use, rather than prohibition,
which removes the need for container size restrictions on similar
consumer conditions of use, because the proposed container size
restrictions are intended to prevent diversion of consumer products to
commercial users.
EPA acknowledges that, for some of the occupational conditions of
use that it is proposing prescriptive workplace requirements there may
be some activities or facilities that could not conceivably implement
the required concentration limits to reduce inhalation and dermal
exposures to NMP. As part of the primary alternative regulatory action,
EPA considered instead a prohibition for the industrial and commercial
use in adhesives and sealants including binding agents, single
component glues and adhesives, including lubricant adhesives and two
component glues and adhesives including some resins and upstream
activities for the consumer use in adhesives and sealants in glues and
adhesives, including lubricant adhesives and sealants. However, as
summarized in this unit, EPA has uncertainty regarding the necessity of
a prohibition for the use of NMP in these conditions of use if the
unreasonable risk could be addressed through a combination of a
concentration limit and PPE (dermal and inhalation) for relevant
industrial or commercial uses, and with a corresponding concentration
limit for consumer products with similar purposes and attributes. EPA
is soliciting comment on prohibiting for these occupational conditions
of use.
Details of the alternative regulatory action are described more in
Unit IV.B.
3. Risk Management Requirements Considered But Not Proposed
Since it is unlikely that all industrial or commercial facilities
with occupational exposures to NMP would be able to implement a WCPP or
prescriptive controls, EPA also examined the extent to which a point-
of-sale self-certification requirement to purchase and subsequently use
NMP would further ensure that only facilities able to implement and
comply with a WCPP or prescriptive controls are able to purchase and
use NMP, and self-certify to that. Under a self-certification
requirement, entities would submit a self-certification to the
distributor each time NMP is purchased. The self-certification would
consist of a statement indicating that the facility is implementing a
WCPP or required prescriptive controls to control exposures to NMP; the
self-certification would be signed and presented by a person authorized
to do so by the facility owner or operator. Copies of the self-
certification would be maintained as records by both the owner or
operator and the distributor where NMP was purchased. While EPA is
proposing to include a requirement for self-certification as part of
the proposed narrow application of the WCPP for two commercial uses of
NMP in paints and coatings and paint, coating, and adhesive removers,
that narrowly tailored self-certification differs from a broader point-
of-sale self-certification requirement that would be applicable to all
commercial users of products containing NMP. The self-certification
proposed for the narrow application of the WCPP relies on the adherence
of a narrowly defined, highly-regulated group of users (DOD, NASA, or
their contractors) performing work at clearly defined facilities for
specific purposes on mission- or safety-critical components in
compliance with the WCPP requirements described in Unit IV.A.3.
In contrast, a broader self-certification requirement would place
requirements on large and diverse groups of users and distributors.
Because of the number and types of entities where users can obtain NMP
or NMP-containing products, EPA does not believe the added requirement
and subsequent burden of a point-of-sale self-certification requirement
for the use of NMP would be an effective tool for preventing facilities
that may be unable to comply with the WCPP or prescriptive controls of
this proposed rulemaking from accessing NMP or NMP-containing products.
As such, EPA is not proposing a self-certification requirement as an
additional component of the requirements for addressing the
unreasonable risk of occupational exposures to NMP. However, EPA is
requesting comment on whether to include a self-certification
requirement for purchasing NMP or NMP-containing products. For example,
EPA is interested in learning if, for distributors and retailers, such
a self-certification requirement would provide greater certainty that
any sale of NMP or NMP-containing products would be for uses that are
not prohibited and are to a facility implementing the WCPP or required
prescriptive controls.
EPA considered setting an ECEL as a regulatory action to address
the unreasonable risk by inhalation and dermal exposures. Previously,
based on a 2015 risk assessment (Ref. 17), EPA proposed a regulatory
action to restrict the use of NMP in commercial and consumer paint and
coating removers that included a co-proposed option to prohibit the use
of formulations with NMP more than 35% by weight and require PPE; that
action was later withdrawn (Refs. 46, 47). Within the PPE requirement,
in 2017, EPA proposed to require certain authorized respirators or an
ECEL value. The ECEL value was dependent on inhalation and dermal
exposures and weight fraction of NMP in the product. This analysis was
specific to the PBPK model used for NMP which accounts for simultaneous
dermal and inhalation exposure. The
[[Page 51172]]
ECEL analysis calculated several variations in exposures and weight
fractions, including 35%, 50%, and 60% NMP. At 60% NMP presented
unreasonable risk to workers even with no air concentration exposure
(Ref. 48). In the 2020 Risk Evaluation for NMP, EPA reanalyzed certain
hazard information compared to the previous 2015 EPA Assessment,
resulting in revised risk estimates in which an ECEL as an alternative
to a respirator requirement would not be feasible to address the
unreasonable risk for the industrial and commercial use of NMP in
paints, coatings, and adhesive removers at 35% by weight NMP. The 2020
Risk Evaluation for NMP used a PBPK model that allowed EPA to evaluate
aggregate exposures from simultaneous dermal, inhalation, and vapor-
thorough-skin exposures associated with specific exposure scenarios
(Ref. 1). The 2020 Risk Evaluation for NMP also compared the internal
exposure to workers from dermal, inhalation, and vapor-through-skin
pathways to the internal exposures to ONUs from inhalation and vapor-
through-skin pathways. The results shows that the proportion of the
exposure largely driving the unreasonable risk to workers and consumers
is due to dermal contact with liquid NMP (Ref. 1) and addressing
inhalation risks alone would not mitigate the unreasonable risk from
NMP. Thus, EPA has not identified and is not proposing to set an ECEL
for NMP. While a level could be set that would account for risk
resulting from inhalation and vapor-through-skin (dermal exposure to
vapor but not direct dermal contact with a liquid) exposures and the
risk from direct dermal exposure at a specified weight fraction, the
Agency is concerned an ECEL value would imply that inhalation is the
primary route of exposure. Further, the 2020 Risk Evaluation identified
a range of NMP weight fractions in the conditions of use, and most
occupational uses of NMP require weight fractions much higher than 35%,
or even 60%. As described in the 2017 NMP ECEL analysis, no ECEL value
would mitigate the unreasonable risk when the weigh fraction is at or
above 60%. Therefore, requirements to meet an ECEL would not address
the unreasonable risk from dermal exposure.
Additionally, the previous proposed ECEL in 2017 was calculated for
one condition of use and exposure scenario and accounted for the
specific concentration limit EPA proposed for that condition of use and
associated products. The previously proposed concentration limit was
intended to result in reduced dermal and inhalation exposure. As a
result, the ECEL included in the 2017 proposed rule was not an ECEL for
all conditions of use of NMP, or even all paint and coating removal
uses of NMP (i.e., any products that would exceed the previously
proposed concentration limit of 35%). This proposed rule for NMP as a
whole chemical regulates 28 occupational conditions of use. For an ECEL
to be useful, EPA would have to propose, for each of these conditions
of use, requirements for dermal PPE, a specific concentration limit,
and a corresponding ECEL. Even if it were feasible to identify such a
large number of separate dermal PPE, concentration limits, and ECELs,
EPA believes it would be potentially burdensome and confusing to the
regulated entities if there were a multitude of requirements for
specific dermal PPE, concentration limits, and inhalation ECELs for
each condition of use that would continue under the WCPP. Regulated
entities could potentially have to comply with several different ECELs
and concentration limits for different conditions of use within one
facility which may not be technically feasible. EPA notes that those
potential concentration limits would most likely be lower than pure
NMP, which many processing conditions of use require, or would be lower
than efficacious for some commercial formulations. Additionally, even
with an ECEL, regulated entities would still have to prevent direct
dermal contact by workers to NMP. For these reasons, instead of
proposing a multitude of ECELs, EPA is proposing a robust WCPP that--
through the requirements to develop and implement exposure control
plan, identify restricted areas, and take mitigation measures to
prevent direct dermal contact--will address the unreasonable risk from
NMP for the specified conditions of use, without adding extra
challenges of ECEL monitoring and compliance.
EPA is also not proposing an existing chemical dermal exposure
limit because biomonitoring methods, such as blood concentration
testing or urine analysis to measure compliance to a dermal exposure
limit, may not be readily available or feasible for most workplaces to
implement. OSHA requires biomonitoring for only three chemicals
(benzene, cadmium, and lead), and has not required any other chemical
biomonitoring since 1981 (Refs. 49, 50, 51). NIOSH has no has no RELs
based on biomonitoring, and EPA is not aware of any standard
biomonitoring practice in the United States for solvents. EPA does not
believe that biomonitoring methods are standard procedures in most
occupational uses and requests public comment if these methods are
viable to implement in the workplace.
To address the unreasonable risk, EPA also considered limiting the
weight fraction of NMP in products and formulations without
requirements for dermal or respiratory PPE. As described in Unit
V.A.1.a., EPA determined that the unreasonable risk from NMP would not
be contributed to by use of products containing NMP at less than 0.1%
by weight. However, for all industrial/commercial and consumer
conditions of use, the concentration limit of 0.1% is so low that it is
highly unlikely that NMP would still serve its functional purpose in
the product or formulation. EPA thus concluded that a weight fraction
restriction without accompanying PPE requirements would essentially
function as a prohibition for the conditions of use listed in Unit
IV.A.2, and EPA therefore did not propose a weight fraction for those
occupational conditions of use. EPA is however proposing a de minimis
level for products containing NMP at levels of less than 0.1% to
account for impurities that do not contribute to the unreasonable risk,
as described in Unit IV.A.1.b.
4. Additional Considerations
After considering the different regulatory options under TSCA
section 6(a), alternatives (described in Unit V.B.), compliance dates,
and other requirements under TSCA section 6(c), EPA developed the
proposed regulatory action described in Unit IV.A. to address the
unreasonable risk from NMP so it is no longer unreasonable. To ensure
successful implementation of this proposed regulatory action, EPA
considered other requirements to support compliance with the proposed
regulations, such as requiring monitoring and recordkeeping to
demonstrate compliance with the NMP WCPP and downstream notification
regarding the prohibition on manufacturing, processing, distribution in
commerce, and use of NMP, including products containing NMP. These
proposed requirements are described in Unit IV.A.
As required under TSCA section 6(d), any rule under TSCA section
6(a) must specify mandatory compliance dates, which shall be as soon as
practicable with a reasonable transition period, but no later than 5
years after the date of promulgation of the final rule (for NMP, EPA
notes an exception for the two uses
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exempted under TSCA section 6(g)). These compliance dates are detailed
in Unit IV.A. and IV.B. EPA may finalize significantly shorter or
longer compliance timeframes based on consideration of public comments.
B. Consideration of Alternatives in Deciding Whether To Prohibit or
Substantially Restrict NMP
Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or
restrict in a manner that substantially prevents a specific condition
of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must consider, to
the extent practicable, whether technically and economically feasible
alternatives that benefit human health or the environment, compared to
the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other
restriction takes effect. To that end, in addition to an Economic
Analysis (Ref. 5), EPA conducted an Alternatives Assessment, using
reasonably available information (Ref. 4).
For this assessment, EPA identified and analyzed alternatives to
NMP in products relevant to industrial, commercial, and consumer
conditions of use proposed to be prohibited or restricted, even if such
restrictions are not anticipated to substantially prevent the condition
of use. Based on reasonably available information, including
information submitted by industry, EPA understands viable alternatives
to NMP may not be available for several conditions of use--for example,
the industrial and commercial use as a solvent (for cleaning or
degreasing) in electrical equipment, appliance and component
manufacturing; for use in semiconductor manufacturing; or the
industrial and commercial use in lithium ion battery manufacturing for
certain applications (Refs. 42, 44)--and considered that information to
the extent practicable in the development of the regulatory options as
described in Unit III.B.3. For some conditions of use (such as the
industrial and commercial use of NMP in anti-freeze and de-icing
products or in lubricants and greases), EPA was unable to identify
products currently available for sale that contain NMP. EPA is
soliciting comments on whether there are products in use or available
for sale relevant to these conditions of use that contain NMP at this
time, so that EPA can ascertain whether there are alternatives that
benefit human health or the environment as compared to such use of NMP.
These conditions of use are detailed in the Alternatives Assessment
(Ref. 4).
For conditions of use for which products currently containing NMP
were identified, EPA identified several hundred commercially available
alternative products that do not contain NMP, and listed in the
Alternatives Assessment, to the extent practicable, their unique
chemical components, or ingredients. For each of these chemical
components or ingredients, EPA identified whether it functionally
replaced NMP for the product use and screened product ingredients for
human health and environmental hazard, as well as identified
flammability and global warming potential where information was
reasonably available (Ref. 4). EPA then assigned a rating to the human
health and environmental hazards, using a methodology described in the
Alternatives Assessment document. In general, EPA identified products
containing ingredients with a lower hazard screening rating than NMP
for certain endpoints, while some ingredients presented higher hazard
screening ratings than NMP (Ref. 4). These alternative hazard screening
ratings are described in detail in the Alternatives Analysis grouped
under common product use categories (Ref. 4).
Discussion of alternatives to NMP occurred during the SBAR Panel
process outreach meetings. EPA's consideration of alternatives was
informed by the information provided by SERs, which included known
problems and risks with some available alternatives. Specifically, SERs
discussed and the challenges of transitioning to alternative chemicals,
which may not be as efficacious as NMP, including the lifespan of use
of their current equipment, capital costs for new equipment and
formulation certification, time to research alternatives and
reformulate products, and compliance with any existing alternative
chemical regulations (Ref. 26). SERs also identified concerns over
certain chemical alternatives such as in extraction uses that are more
toxic or flammable than NMP, or in coating removal uses where certain
chemical alternatives also present supply chain challenges and limited
or reduced availability compared to NMP. EPA notes the concerns
expressed by SERs regarding availability of feasible alternatives.
These discussions with SERs informed the Panel recommendations.
EPA has considered input from SERs and other stakeholders regarding
alternatives to NMP, as well as the information used for the
Alternatives Assessment.
In deciding whether to propose prohibition or other significant
restrictions on a condition of use of NMP and in proposing an
appropriate transition period for any such action, EPA has therefore,
pursuant to TSCA section 6(c)(2)(C), considered, to the extent
practicable, whether technically and economically feasible alternatives
that benefit human health or the environment, compared to the use
proposed to be prohibited or restricted, would be reasonably available
as a substitute when a proposed prohibition or other significant
restriction would become effective. EPA is additionally requesting
comment on the Alternatives Assessment as a whole.
VI. TSCA Section 6(c)(2) Considerations
A. Health Effects of NMP and the Magnitude of Human Exposure to NMP
EPA's analysis of the health effects of NMP and the magnitude of
human exposure to NMP are in the 2020 Risk Evaluation for NMP (Ref. 1).
A summary is presented here.
The 2020 Risk Evaluation for NMP identified potential health
effects of NMP including non-cancer adverse health effects such as
reproductive toxicity, developmental toxicity, liver toxicity, kidney
toxicity, immunotoxicity, neurotoxicity, and irritation and
sensitization.
Among the non-cancer adverse health effects, for acute inhalation
and dermal exposure scenarios, EPA identified non-cancer developmental
effects (i.e., increased fetal resorptions and mortality) as the most
sensitive endpoint. For chronic inhalation and dermal exposure
scenarios, EPA identified non-cancer reproductive effects (decreased
fertility) as the most sensitive endpoints. NMP is not mutagenic and is
not considered carcinogenic, so EPA did not conduct analysis of
genotoxicity and cancer hazards in the risk evaluation.
Regarding the magnitude of human exposure, one factor EPA considers
for the conditions of use that contribute to unreasonable risk is the
size of the exposed population, which, for NMP, EPA estimates is
226,000 workers and 193,000 ONUs (Ref. 5). The number of consumers that
use adhesive products containing NMP each year is unknown. EPA did not
identify any consumer adhesive and sealant products containing NMP
(Ref. 5).
For the conditions of use that contribute to the unreasonable risk
for NMP, PESS include workers, ONUs, consumer users, bystanders, males
and
[[Page 51174]]
females of reproductive age, pregnant women and the developing embryo/
fetus, infants, children and adolescents, people with pre-existing
conditions and people with lower metabolic capacity due to life stage,
genetic variation, or impaired liver function.
In addition to workers, ONUs, consumers, and bystanders to consumer
use directly exposed to NMP, EPA recognizes there is exposure to the
general population from air and water pathways for NMP. During problem
formulation, EPA conducted a first-tier screening analysis, for the
ambient air pathway to near-field populations downwind from industrial
and commercial facilities releasing NMP, that indicated low risk. In
the 2020 Risk Evaluation, EPA conducted a first-tier analysis to
estimate NMP surface water concentrations and did not identify risks
from incidental ingestion or dermal contact during swimming. As
mentioned in Unit II.D., EPA has separately conducted a screening
approach to assess whether there may be potential risks to the general
population from these exposure pathways that were unaccounted for in
the NMP problem formulation and 2020 Risk Evaluation. The screening
approach was developed to allow EPA to determine--with confidence--
situations which present no unreasonable risk to fenceline communities
or where further investigation would be needed to develop a more-
refined estimate of risk. The fenceline technical support memos for the
ambient air pathway and the water pathway provide the Agency with a
quantitative assessment of exposure. EPA's fenceline analysis for the
air pathway did not find risks to fenceline communities from ambient
air (Ref. 15). EPA's fenceline analysis for the water pathway did not
find risks from drinking water (Ref. 16). EPA therefore does not intend
to revisit these air and water pathways for NMP as part of a
supplemental risk evaluation.
B. Environmental Effects of NMP and the Magnitude of Exposure of the
Environment to NMP
EPA's analysis of the environmental effects of NMP and the
magnitude of exposure of the environment to NMP are in the 2020 Risk
Evaluation for NMP (Ref. 1). The unreasonable risk determination for
NMP is based solely on risks to human health; based on the TSCA 2020
Risk Evaluation for NMP, EPA determined that exposures to the
environment did not contribute to the unreasonable risk. A summary is
presented here.
The manufacturing, processing, use, and disposal of NMP can result
in releases to the environment, including aquatic releases of NMP from
facilities that manufacture, use, or process NMP. Fate, exposure, and
environmental hazard were evaluated in the 2020 Risk Evaluation for NMP
to characterize environmental risk of NMP. NMP is not likely to
accumulate in sediment due to its water solubility and low partitioning
to organic matter. Upon releases of NMP to the atmosphere, it is
degraded via reaction with photochemically produced hydroxyl radicals
in ambient air. It may migrate through soil into groundwater, where NMP
readily biodegrades in environments with active microbial populations.
Additionally, NMP has low potential for bioaccumulation and
bioconcentration in the environment.
Potential effects of NMP exposure described in the literature for
aquatic life include mortality, immobilization, growth effects, and
reproductive effects. EPA concluded that NMP poses a hazard to
environmental aquatic organisms, including aquatic invertebrates, fish,
and aquatic plants (algae). For acute exposures, NMP is a hazard to
aquatic invertebrates based on immobilization and mortality, to fish
based on mortality, and algae based on growth effects. For chronic
exposures, NMP is a hazard to aquatic invertebrates based on
reproductive effects, to fish based on an acute to chronic ratio
approach extrapolating from the acute fish toxicity data, and to algae
based on growth effects. EPA incorporated modeled exposure data from
the Exposure and Fate Assessment Screening Tool or E-FAST as well as
monitored data from the Water Quality Portal (Ref. 1), to characterize
the exposure of NMP to aquatic species.
In the 2020 Risk Evaluation for NMP, the indicators evaluated for
risk of injury to the environment include immobilization from acute
exposure, growth effects from chronic exposure, and mortality to algae
(Ref. 1). Based on the 2020 Risk Evaluation for NMP, EPA did not
identify risk of injury to the environment that contributes to the
unreasonable risk determination for NMP.
C. Benefits of NMP for Various Uses
NMP is a water-miscible, organic compound used in a variety of
industrial, commercial, pharmaceutical, and consumer use applications,
including as a processing aid, as a solvent in petrochemical
processing, in the production of electronics, cleaning and degreasing,
and producing and removing paint, coatings, adhesives, and sealants,
and other uses. The physical and chemical properties of NMP, such as
low-flammability, low volatility, low vapor pressure, high boiling
point, low viscosity and high affinity for aromatic hydrocarbons make
it a popular and effective solvent and surface treatment for many
applications (Ref. 1). Besides its use as a solvent, NMP is utilized in
the recovery of hydrocarbons in the processing of petrochemicals. It is
also used in the absorption of hydrogen sulfide in hydrodesulfurization
facilities and the commercial preparation of polyphenylene sulfide, a
high-performance engineering thermoplastic. In the pharmaceutical
industry, NMP is used in the formulation of oral and transdermal drugs.
The main uses of NMP, by production volume, are in paint and
coating removers, paints and coatings, electronics manufacturing, and
plastic and resin manufacturing (Ref. 5). NMP effectively chemically
removes various coatings from a substrate, such as furniture coatings
or graffiti paint. There appears to be a trend towards alternatives to
NMP in paint and coating removers as a result of the proposed rule
published by EPA under TSCA section 6 in January 2017 regulating
certain uses of methylene chloride and NMP (82 FR 7464). While that
proposed rule was withdrawn in January of 2021, since January 2017,
based on market research, the availability of consumer and commercial
paint and coating removal products containing NMP has declined.
However, there appears to be a market trend expanding electronic
manufacturing in the United States, particularly as it related to
lithium ion battery manufacturing and electronic vehicles and
semiconductor chips. These production processes include uses of NMP
with no known alternative and are expected to require the continued use
of NMP over time.
In petrochemical manufacturing, NMP is used as a processing aid and
extraction solvent. NMP is also used in a variety of cleaning products
used in multiple industrial facilities and commercial shops, in
soldering materials, and enhanced fertilizers.
EPA requests comments from the public about the importance of NMP
in multiple existing product categories, including the potentially
increased future importance of NMP to innovation and as an alternative.
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D. Reasonably Ascertainable Economic Consequences of the Proposed Rule
1. Likely Effect of the Rulemaking on the National Economy, Small
Business, Technological Innovation, the Environment, and Public Health
The reasonably ascertainable economic consequences of this proposed
rule include several components, all of which are described in the
Economic Analysis for this proposed rule (Ref. 5). With respect to the
anticipated effects of this proposed rule on the national economy, EPA
considered the number of businesses and workers that would be affected
and the costs and benefits to those businesses and workers and did not
find that there would be an impact on the national economy (Ref. 5).
The economic impact of a regulation on the national economy becomes
measurable only if the economic impact of the regulation reaches 0.25%
to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is
equivalent to a cost of $40 billion to $80 billion. Therefore, because
EPA has estimated that the cost of the proposed rule would range from
$396 million annualized over 20 years at a 3% discount rate and $397
million annualized over 20 years at a 7% discount rate, EPA has
concluded that this rulemaking is unlikely to have any measurable
effect on the national economy (Ref. 5). Cost estimates by use category
are provided in the Economic Analysis Table 7-36 (Ref. 5). In addition,
EPA considered the employment impacts of this proposed rule, and found
that the direction of change in employment is uncertain, but EPA
expects the short-term and longer-term employment effects to be small.
Of the 61,851 small businesses potentially impacted by this
proposed rule, 72% or 44,388 are expected to have impacts of less than
1% to their firm revenues, 11% or 6,965 are expected to have impacts
between 1 and 3% to their firm revenues, and 17% or 10,497 are expected
to have impacts greater than 3% to their firm revenues. Most businesses
that would be affected by this regulation are in the following sectors:
paints and coatings; paint, coating, adhesive removers; adhesive and
sealants; inks, toners, and colorant products; and soldering. In
addition to these sectors, some users of NMP (such as in plastic and
resin product manufacturing or waste and disposal) may be significantly
impacted because they have specific technical requirements which make
the cost of modifications in response to WCPP requirements or the
efficacy of potential alternatives hard to determine and appropriately
capture in the analysis.
With respect to this proposed rule's effect on technological
innovation, EPA expects this rulemaking to spur more innovation than it
will hinder. A prohibition or significant restriction on the
manufacture, processing, and distribution in commerce of NMP for uses
covered in this proposed rule may increase demand for safer chemical
substitutes. This proposed rule is not likely to have significant
effects on the environment because NMP does not present an unreasonable
risk to the environment, though this proposed rule does present the
potential for small reductions in air emissions and soil contamination
associated with improper disposal of products containing NMP. The
effects of this proposed rule on public health are estimated to be
positive, due to the reduced risk of non-cancer endpoints from exposure
to NMP.
2. Costs and Benefits of the Proposed Regulatory Action and of the
Alternative Regulatory Actions Considered by the Administrator
The costs and benefits that can be monetized for this proposed rule
are described at length in in the Economic Analysis (Ref. 5). The
monetized costs for this proposed rule are estimated to range from $396
million annualized over 20 years at a 3% discount rate and $397 million
annualized over 20 years at a 7% discount rate. See the Economic
Analysis Table 7-36 where total monetized costs are broken out per
component of the proposed rule (Ref. 5). The health endpoints for NMP
cannot be monetized at this time. However, as discussed in Unit IV.E.,
those endpoints can have significant, negative impacts on the lives of
those exposed to NMP resulting in low birth weight, fetal loss, kidney
toxicity, liver toxicity, and issues with fertility and fecundity (Ref.
5).
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
alternative regulatory actions are described in detail in Unit IV.B.
The estimated annualized costs of the alternative regulatory action are
$165 million at a 3% discount rate and $185 million at a 7% discount
rate over 20 years (Ref. 5). Again, the health endpoints for NMP cannot
be monetized at this time. However, as discussed in Unit IV.E., those
endpoints can have significant, negative impacts on the lives of those
exposed to NMP resulting in low birth weight, fetal loss, kidney
toxicity, liver toxicity, and issues with fertility and fecundity (Ref.
5).
This proposal is expected to achieve health benefits for the
American public, that while tangible and significant, cannot be
monetized. EPA believes that the balance of costs and benefits of this
proposal cannot be fairly described without considering the non-
monetized benefits of mitigating the non-cancer adverse effects. The
multitude of adverse effects from NMP exposure can profoundly impact an
individual's quality of life, as discussed in Units I.E. (estimated
incremental impacts of the proposed rule), III.B.2. (description of the
unreasonable risk), and VI.A. (discussion of the health effects), and
also the 2020 Risk Evaluation for NMP. Chronic adverse effects of NMP
exposure include the non-cancer effects listed in this unit. Acute
effects of NMP exposure could be experienced for a shorter portion of
life but are nevertheless significant in nature. The incremental
improvements in health outcomes such as reproductive or developmental
effects achieved by given reductions in exposure cannot be quantified
for non-cancer health effects associated with NMP exposure, and
therefore cannot be converted into monetized benefits. The qualitative
discussion throughout this rulemaking and in the Economic Analysis
highlights the importance of these non-cancer effects. Dismissing
nonmonetized benefits of this rulemaking underestimates the impacts of
NMP adverse outcomes and would imply there are no health benefits of
this proposed rule from a reduction in NMP exposure.
3. Cost Effectiveness of the Proposed Regulatory Action and Alternative
Regulatory Actions Considered by the Administrator
Cost effectiveness is a method of comparing certain actions in
terms of the expense per item of interest or goal. The goal of this
proposed regulatory action is to prevent unreasonable risk resulting
from exposure to NMP, and a major component of this regulatory action
is eliminating or reducing NMP exposure to workers and ONUs. Per
potentially exposed worker or ONU, the proposed regulatory action would
cost $944 while the alternative regulatory action would cost $395
(using the 3% discount rate) to achieve the same goals. At a 7%
discount rate, the proposed regulatory action would cost $948 while the
alternative regulatory action would cost $442 per potentially exposed
worker or ONU. While the proposed option has higher monetized costs, it
may allow for more flexibility in some
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sectors. In addition, the proposed option may result in potential lower
exposures to workers and ONUs using NMP compared to the alternative
option leading to reduced potential negative health outcomes for
workers (Ref. 5).
VII. TSCA Section 9 Analysis, Section 14, and Section 26 Considerations
A. TSCA Section 9(a) Analysis
TSCA section 9(a) provides that, if the Administrator determines,
in the Administrator's discretion, that an unreasonable risk may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA, the Administrator must submit a
report to the agency administering that other law that describes the
risk and the activities that present such risk. TSCA section 9(a)
describes additional procedures and requirements to be followed by EPA
and the other Federal agency following submission of any such report.
As discussed in this unit, for this proposed rule, the Administrator
proposes to exercise his discretion not to determine that the
unreasonable risk from NMP under the conditions of use may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA.
In addition, TSCA section 9(d) instructs the Administrator to
consult and coordinate TSCA activities with other Federal agencies for
the purpose of achieving the maximum enforcement of TSCA while imposing
the least burdens of duplicative requirements. For this proposed rule,
EPA has and continues to coordinate with appropriate Federal executive
departments and agencies, including OSHA and the Consumer Product
Safety Commission (CPSC), to, among other things, identify their
respective authorities, jurisdictions, and existing laws with regard to
NMP, which are summarized in this unit.
OSHA requires that employers provide safe and healthful working
conditions by setting and enforcing standards and by providing
training, outreach, education and assistance. As described in Unit
II.C., OSHA has not established a PEL for NMP. Gaps exist between
OSHA's authority to set workplace standards under the OSH Act and EPA's
obligations under TSCA section 6 to eliminate unreasonable risk
presented by chemical substances under the conditions of use. Health
standards issued under section 6(b)(5) of the OSH Act must reduce
significant risk only ``to the extent feasible.'' 29 U.S.C. 655(b)(5).
To set PELs for chemical exposure, OSHA must first establish that the
new standards are economically and technologically feasible (79 FR
61384, 61387, Oct. 10, 2014). But under TSCA section 6(a), EPA's
substantive burden is to demonstrate that, as regulated, the chemical
substance no longer presents an unreasonable risk, with unreasonable
risk being determined without consideration of costs or other non-risk
factors. Thus, if OSHA were to initiate a new action, the difference in
standards between the OSH Act and TSCA may well result in an OSHA
action insufficient to address the unreasonable risk under TSCA.
In addition, OSHA may set exposure limits for workers, but its
authority is limited to the workplace and does not extend to consumer
uses of hazardous chemicals, and thus OSHA cannot address the
unreasonable risk from NMP under all of its conditions of use, which
include consumer uses. OSHA also does not have direct authority over
state and local employees, and it has no authority over the working
conditions of state and local employees in states that have no OSHA-
approved State Plan under 29 U.S.C. 667.
CPSC, under authority provided to it by Congress in the CPSA,
protects the public from unreasonable risk of injury or death
associated with the use of consumer products. Under the CSPA, CPSC has
the authority to regulate NMP in consumer products, but not in other
sectors such as automobiles, industrial and commercial products, or
aircraft, for example. Further, a consumer product safety rule under
the CPSA must include a finding that ``the benefits expected from the
rule bear a reasonable relationship to its costs,'' 15 U.S.C.
2058(f)(3)(E), whereas EPA must apply TSCA risk management requirements
to the extent necessary so that the chemical no longer presents
unreasonable risk and only consider costs and benefits of the
regulatory action to the extent practicable, 15 U.S.C. 2605(a), (c)(2).
Additionally, the 2016 amendments to TSCA reflect Congressional intent
to ``delete the paralyzing `least burdensome' requirement,'' 162 Cong.
Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as
originally enacted, which required EPA to use ``the least burdensome
requirements'' that protect ``adequately'' against unreasonable risk,
15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under
the CPSA must impose ``the least burdensome requirement which prevents
or adequately reduces the risk of injury for which the rule is being
promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at
variance with recent revisions to TSCA, affect the availability of
action CPSC may take under the Federal Hazardous Substances Act (FHSA)
relative to action EPA may take under TSCA. 15 U.S.C. 1262.
EPA therefore concludes that TSCA is the only regulatory authority
able to prevent or reduce unreasonable risk of NMP to a sufficient
extent across the range of conditions of use, exposures and populations
of concern. This unreasonable risk can be addressed in a more
coordinated, efficient and effective manner under TSCA than under
different laws implemented by different agencies. Moreover, the
timeframe and any exposure reduction as a result of updating OSHA or
CPSC regulations cannot be estimated, while TSCA requires a much more
accelerated 2-year statutory timeframe for proposing and finalizing
regulatory requirements to address unreasonable risk. Further, there
are key differences between the finding requirements of TSCA and those
of the OSH Act, CPSA, and FHSA. For these reasons, in the
Administrator's discretion, the Administrator has analyzed this issue
and does not determine that unreasonable risk from NMP may be prevented
or reduced to a sufficient extent by an action taken under a Federal
law not administered by EPA. However, EPA is requesting public comment
on this issue (i.e., the sufficiency of an action taken under a Federal
law not administered by EPA).
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce a risk to health or the environment, TSCA section 9(b) instructs
EPA to use these other authorities to protect against that risk unless
the Administrator determines in the Administrator's discretion that it
is in the public interest to protect against such risk under TSCA. In
making such a public interest finding, TSCA section 9(b)(2) states:
``the Administrator shall consider, based on information reasonably
available to the Administrator, all relevant aspects of the risk . . .
and a comparison of the estimated costs and efficiencies of the action
to be taken under this title and an action to be taken under such other
law to protect against such risk.''
Although several EPA statutes have listed NMP as a volatile organic
compound (Ref. 7), regulations under those EPA statutes have
limitations because they largely regulate releases to the environment,
rather than occupational or consumer exposures. While these limits on
releases to the environment are protective in the
[[Page 51177]]
context of their respective statutory authorities, regulation under
TSCA is also appropriate for occupational and consumer exposures and in
some cases can provide upstream protections that would prevent the need
for release restrictions required by other EPA statutes (e.g., Resource
Conservation and Recovery Act (RCRA), CAA, Clean Water Act (CWA)),
including their associated permits.
The primary exposures and unreasonable risk to consumers and
workers would be addressed by EPA's proposed prohibitions and
restrictions under TSCA section 6(a). In contrast, the timeframe and
any exposure reduction as a result of updating regulations for NMP
under the CAA, CWA, or RCRA cannot be estimated, nor would they address
the direct human exposure to consumers and workers from the conditions
of use evaluated in the 2020 Risk Evaluation for NMP. More
specifically, none of EPA's other statutes (e.g., RCRA, CAA, CWA) can
address exposures to workers related to the specific activities that
result in occupational exposures, for example those associated with
RCRA covered disposal requirements. EPA therefore concludes that TSCA
is the most appropriate regulatory authority able to prevent or reduce
risks of NMP to a sufficient extent across the range of conditions of
use, exposures, and populations of concern.
For these reasons, the Administrator does not determine that
unreasonable risk from NMP under the conditions of use evaluated in the
2020 TSCA Risk Evaluation for NMP could be eliminated or reduced to a
sufficient extent by actions taken under other Federal laws
administered in whole or in part by EPA.
C. TSCA Section 14 Requirement
EPA is also providing notice to manufacturers, processors, and
other interested parties about potential impacts to CBI that may occur
if this rulemaking is finalized as proposed. Under TSCA section
14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that
establishes a ban or phase-out of a chemical substance, the protection
from disclosure of any CBI regarding that chemical substance and
submitted pursuant to TSCA will be ``presumed to no longer apply,''
subject to the limitations identified in TSCA section 14(b)(4)(B)(i)
through (iii). If this rulemaking is finalized as proposed, then
pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against
protection from disclosure would apply only to information about the
specific conditions of use that this proposed rule would prohibit.
Manufacturers or processors seeking to protect such information would
be able to submit a request for nondisclosure as provided by TSCA
sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure
would need to be submitted within 30 days after receipt of notice from
EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such
notice via the Central Data Exchange or CDX.
D. TSCA Section 26 Considerations
In accordance with TSCA section 26(h), EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science.
As in the case of the unreasonable risk determination, risk management
decisions for this proposed rule, as discussed in Unit III.B.3. and
Unit V., were based on a risk evaluation that was subject to public
comment and independent, expert peer review, and was developed in a
manner consistent with the best available science and based on the
weight of the scientific evidence as required by TSCA sections 26(h)
and (i) and 40 CFR 702.43 and 702.45.
In particular, the WCPP, prescribed concentration limits, and de
minimis concentration limit are derived from the analysis in the 2020
Risk Evaluation for NMP; they likewise represent decisions based on the
best available science and the weight of the scientific evidence (Ref.
37). As discussed in Unit V.A.1., EPA used supplemental modeling from
the 2020 Risk Evaluation for NMP to derive the proposed de minimis
concentration limit, which represents a level below which EPA would not
expect product use to contribute to unreasonable risk.
The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decisions have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rule. Additional information on the peer review and public
comment process, such as the peer review plan, the peer review report,
and the Agency's response to comments, can be found in EPA's risk
evaluation docket (Docket ID No.: EPA-HQ-OPPT-2016-0743).
VIII. Requests for Comment
EPA is requesting public comment on all aspects of this proposal,
including the proposed and alternative regulatory actions and all
individual elements of these, and all supporting analysis.
Additionally, within this proposal, the Agency is soliciting feedback
from the public on specific issues throughout this proposed rule. For
ease of review, this unit summarizes those specific requests for
comment, with numbering provided to help simplify referencing.
1. In Unit I.C., EPA seeks public comment on all aspects of this
proposal.
2. In Unit I.E., EPA seeks public comment on methodologies for
developing noncancer human dose-response curves and valuation methods
for the health endpoints identified for NMP in the Risk Evaluation,
specifically willingness to pay studies.
3. In Unit III.A., EPA is requesting public comment on all elements
of the proposed regulatory action and the alternative regulatory
actions and is providing notice that based on consideration of comments
and any new information submitted to EPA during the comment period on
this proposed rule, EPA may in the final rule modify elements of the
proposed regulatory action.
4. In Unit III.B.1., EPA requests comment on whether EPA should
promulgate definitions for those conditions of use evaluated in the
2020 Risk Evaluation for NMP that would not be prohibited, and, if so,
whether the descriptions in this unit are consistent with the
conditions of use evaluated in the 2020 Risk Evaluation for NMP and
whether they provide a sufficient level of detail to improve the
clarity and readability of the regulation.
5. In Unit IV.A., EPA requests comment on allowing this de minimis
level of NMP in products to account for impurities.
6. In Unit IV.A.1., EPA requests comment on whether additional time
is needed, for example, for products to clear the channels of trade, or
for implementing the use of substitutes. Comments should include
documentation such as the specific use of the chemical throughout the
supply chain; concrete steps taken to identify, test, and qualify
substitutes for those uses (including details on the substitutes tested
and the specific certifications that would require updating); and
estimates of the time required to identify, test, and qualify
substitutes with supporting documentation.
7. In Unit IV.A.1., EPA requests comment on whether these are the
appropriate types of information for use in evaluating compliance
requirements, and whether there are other considerations that should
apply.
8. In Unit IV.A.1., EPA is requesting comment on: (1) Whether
respiratory
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protection and dermal PPE should be required before the effective date
of the prohibition; (2) To what extent inhalation and dermal PPE may
already be implemented in most uses being prohibited; and (3) Whether
requirements that inhalation and dermal PPE be used before the
effective dates of prohibitions would be overly burdensome to entities
indicated in this unit that would be working to comply with the
prohibition.
9. In Unit. IV.A.1., EPA is requesting comments from the public for
more information about the uses EPA is proposing to prohibit,
particularly the industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents, and
the ability for workplaces in these conditions of use to comply with
strict workplace controls like those required under the WCPP, or the
ability to comply with a prohibition and reformulate to an alternative
chemical or process.
10. In Unit IV.A.1., EPA requests comments on an appropriate,
predictable process that could expedite reconsideration for uses that
Federal agencies or their contractors become aware of after the final
rule is issued using the tools available under TSCA, aligning with the
requirements of TSCA section 6(g). EPA requests comment on whether the
types of information described are the appropriate types of information
for use in evaluating this type of category of use, and whether there
are other considerations that should apply.
11. In Unit IV.A.1., EPA solicits comment on all aspects of its
steps to accommodate in this proposed rule uses needed for national
security or critical infrastructure and whether any additional measures
are needed.
12. In Unit IV.A.2., EPA is requesting public comment on whether
meeting this container size restriction to prevent commercial use would
also have the same, though unintended, effect of reducing the consumer
use.
13. In Unit IV.A.2., EPA requests comment on whether additional
time is needed, for example, for products to clear the channels of
trade, or for implementing the container size restriction, and on what
an appropriate container size restriction should be if not 16 ounces,
and why.
14. In Unit IV.A.2., EPA is also seeking public comment on any
alternative options to prevent diversion of consumer products to
commercial uses. Comments should include documentation such as the
specific container sizes of the NMP-containing products and estimates
of the time and expenses required to implement the labeling
requirement. EPA may finalize significantly shorter or longer
compliance timeframes based on consideration of public comments.
15. In Unit IV.A.3., EPA requests comment on available approaches,
specifically monitoring methods (e.g., charcoal patch testing) and
frequency of sampling, to determine the effectiveness of engineering
and administrative controls in preventing or reducing potential direct
dermal contact to NMP.
16. In Unit IV.A.3., EPA also requests comment on whether requiring
reporting on such monitoring could support enforcement and compliance
assurance with this rulemaking.
17. In Unit IV.A.3., EPA requests comment on whether there should
be general housekeeping or cleaning requirements in areas where the NMP
is handled or where surfaces may be contaminated with NMP.
18. In Unit IV.A.3., EPA is also soliciting comment on requiring
warning signs to demarcate restricted areas, similar to the
requirements found in OSHA's General Industry Standard for Beryllium
(29 CFR 1910.1024(m)(2)).
19. In Unit IV.A.3., EPA is requesting comment on whether there
should be a requirement to replace cartridges or canisters after a
certain number of hours, such as the requirements found in OSHA's
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a
requirement for a minimum service life of non-powered air-purifying
respirators such as the requirements found in OSHA's General Industry
Standard for Benzene (29 CFR 1910.1028(g)(3)(D)).
20. In Unit IV.A.3., EPA is soliciting comments on the non-
prescriptive proposed DDCC requirements for appropriate PPE selection,
the effectiveness of PPE in preventing direct dermal contact with NMP
in the workplace.
21. In Unit IV.A.3., EPA requests information on other potential
dermal performance standards, and on general absorption and permeation
effects to PPE as a result of direct contact.
22. In Unit IV.A.3., EPA understands that some workplaces rinse and
reuse PPE after minimal use and is therefore soliciting comments on the
impact on effectiveness of rinsing and reusing certain types of PPE,
either gloves or protective clothing and gear.
23. In Unit IV.A.3., EPA also requests comment on the degree to
which additional guidance related to use of PPE might be appropriate,
including specifying PPE type or additional standard testing
specifications.
24. In Unit IV.A.3., EPA is requesting comment on how owners and
operators can engage with potentially exposed persons on the
development and implementation of an exposure control plan and PPE
program.
25. In Unit IV.A.3., EPA requests comment relative to the ability
of owners or operators in the private sector to implement such
processes within 12 months of publication of the final rule in the
Federal Register, and anticipated timelines for any procedural
adjustments needed to comply with the requirements outlined in this
unit. EPA also requests comment on whether the additional two years
provided for agencies of the Federal Government and their contractors,
when acting for or on behalf of the Federal government, to comply with
the WCPP, should be provided more broadly to all entities complying
with the WCPP.
26. In Unit IV.A.4., EPA is requesting comment on whether there
should be a requirement to replace cartridges or canisters after a
certain number of hours, such as the requirements found in OSHA's
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051(h)), or a
requirement for a minimum service life of non-powered air-purifying
respirators such as the requirements found in OSHA's General Industry
Standard for Benzene (29 CFR 1910.1028(g)(3)(D)).
27. In Unit IV.A.4., EPA is requesting public comment on whether
additional documentation should be required to further support
compliance and enforceability of the proposed regulatory requirements
(e.g., requirements for labels or SDS identifying percent of NMP within
a product, or downstream notification of these proposed requirements
for concentration limits and PPE, or other information that would be
made available to industrial and commercial users to indicate
compliance with the concentration limits).
28. In Unit IV.A.4., EPA requests comment on whether additional
time is needed, other concentrations are required, or if there are
available substitutes for this application.
29. In Unit IV.A.5., EPA is requesting public comment on whether
additional documentation should be required to further support
compliance and enforceability of the proposed regulatory requirements
(e.g., requirements for labels identifying the percent of NMP within a
product or downstream notification of these proposed requirements for
concentration limits).
30. In Unit IV.A.5., EPA requests comment on whether additional
time is
[[Page 51179]]
needed, other concentrations are required, or if there are available
substitutes for this application.
31. In Unit IV.A.6., EPA requests comments on all aspects of the
proposed applicability of the WCPP to these narrowly described uses of
higher concentration NMP in paint, coating, and adhesive removal and
paints and coatings.
32. In Unit IV.A.6., EPA also requests comment on whether entities
other than DOD, NASA or its contractors also require high concentration
NMP and, if so, the extent to which lack of availability of high
concentration NMP could impact their operations or pose potential
challenges to the supply chain.
33. In Unit IV.A.6., EPA is requesting comment on whether EPA
should also require reporting to EPA during purchasing of NMP for these
specific uses by DOD, NASA, or their contractors and if requiring
reporting could support of enforcement and compliance assurance with
this rulemaking by further assuring that distribution of these high
concentration NMP products for these uses is limited to DOD, NASA, and
their contractors, and if such requirements would impose significant
administrative burdens in addition compliance with the WCPP.
34. In Unit IV.A.7., EPA requests comments on the appropriateness
of identified compliance timeframes for recordkeeping and downstream
notification requirements described in this unit.
35. In Unit IV.B.1., EPA requests comment on this alternative
regulatory action and whether any elements of this alternative
regulatory action described in this unit should be considered as EPA
develops the final regulatory action.
36. In Unit IV.B.1., EPA also requests comment on any advantages or
drawbacks for the timelines outlined in this unit compared to the
timelines identified for the proposed regulatory action in Unit IV.A.
37. In Unit IV.B.1., EPA requests comment on the ways in which NMP
may be used in these conditions of use, including whether activities
may take place in a closed system and the degree to which users of NMP
in these sectors could successfully implement a WCPP (including DDCC)
and ancillary requirements described in Unit IV.A.
38. In Unit IV.B.1., EPA is also requesting comment on whether any
of the uses listed in this unit should be prohibited instead of
requiring a WCPP, or if there are other factors like reduced
concentration limits or limited access that could address the
unreasonable risk.
39. In Unit IV.B.1., EPA requests comment on any advantages or
drawbacks for the timelines outlined in this unit compared to the
timelines identified for the proposed regulatory action in Unit IV.A.
40. In Unit V.A.1., EPA requests comment on the workplace
protection measures or exposure reduction measures typically applied
during dip application of NMP, particularly dip degreasing and cleaning
in hot or cold dip-tank immersion cleaning and degreasing, and dip
application of NMP for adhesive, paint, or coating removal.
41. In Unit V.A.1., EPA also requests comment on the typical tasks
expected during hot and cold dip cleaning or coating removal
operations, including manual or automated opening and closing of the
dip tank, cleaning and maintenance, the use of new or repurposed vapor
degreasing machines for immersion cleaning, or any other dip-tank or
immersion cleaning and degreasing activities.
42. In Unit V.A.1., EPA is interested in for comments on the
ability of users of high concentrations of NMP in dip applications to
successfully implement a WCPP, the availability of alternative
chemicals, and impacts of prohibiting NMP for the hot or cold dip-tank
cleaning, degreasing, or removal of adhesives, paints, or coatings.
43. In Unit V.A.1., EPA requests comment on the number of firms who
utilize hot or cold dip NMP for cleaning, degreasing, or removal of
adhesives, paints, and coatings and the frequency of dip applications
and size of the dip vessel per firm is also of interest to EPA.
44. In Unit V.A.1., EPA also requests comment on the types of
engineering controls and any PPE use by firms who use NMP in hot or
cold dip applications.
45. In Unit V.A.1., EPA requests comment on how NMP is used in the
agricultural sector, including whether there are any other application
types (such as aerosol application) besides liquid product containing
NMP blended with solid fertilizer pellets. EPA requests comment and
supporting information on the degree to which entities using NMP in
fertilizer manufacture or application may comply with the proposed WCPP
requirements or similar stringent workplace controls for other
conditions of use of NMP. EPA also requests comment on the workplace
safety protocols in place during application, including expected
exposure reductions during the use of NMP in fertilizer mixing and
application, current engineering controls used, PPE usage and any
standard hazard warnings or instructions in place. Specifically, EPA
requests comments on whether there are alternatives to NMP for solvents
used in the production of fertilizers, as well as alternatives to the
use of NMP to reduce the volatility of advanced fertilizer products by
keeping nitrogen from volatilizing into the atmosphere before it can be
absorbed into the soil.
46. In Unit V.A.1., EPA requests comment regarding the number of
businesses and other entities that could potentially close as well as
associated costs with a prohibition of NMP for the industrial and
commercial conditions of use identified in Unit IV.A.1.a.
47. In Unit V.A.1., EPA is requesting comment on the de minimis
concentration limit of NMP in products or formulations. EPA emphasizes
the agency's interest in aligning to the extent possible with the de
minimis thresholds in the OSHA Hazard Communication Standard, while
also noting that additional analytical work was conducted for NMP.
48. In Unit V.A.1., EPA requests comment on whether de minimis
thresholds should be proposed consistent with national and
international regulations, or whether there may be instances where
chemical-specific analyses is appropriate.
49. In Unit V.A.1., EPA requests comment on if there are any NMP-
containing consumer products that may require a more frequent or
multiple day application, and if so, should EPA require additional
restrictions for consumer products.
50. In Unit V.A.1., EPA requests comment on the potential impacts
to consumers and the consumer use of these products from a container
size requirement, as well as the appropriateness of the proposed
respiratory protection requirements for these conditions of use as
listed in Unit IV.A.4 and any impacts that the prescriptive use of
respiratory protection may have on workplace operations.
51. In Unit V.A.1., EPA is also requesting comment on whether,
rather than a container size restriction requirement, a maximum
concentration limit for products containing NMP be required instead.
52. In Unit V.A.1., EPA requests comment on the typical or
effective concentration of NMP in the following consumer products:
paint and coating removers, adhesive removers, paints and coatings,
paint additives and coating additives in arts and crafts paint,
automotive care products, cleaning and furniture care products, and
lubricant and lubricant additives, and whether a maximum concentration
[[Page 51180]]
of NMP could be identified that would allow the product to continue to
be efficacious for consumer use, but that would not exceed the
concentrations EPA has identified in Unit IV.A.1.e. for addressing the
contribution of these types of products to unreasonable risk for
workers.
53. In Unit V.A.1., EPA is seeking comment on whether the WCPP,
with no concentration limits, should apply to all users of NMP in
paints and coatings, and paint, coating and adhesive removal, rather
than narrowly to DOD and NASA.
54. In Unit V.A.1., EPA is requesting comment on whether additional
circumstances where specific PPE (including respirators) should be
prescribed, as well as on the impacts on operations of requirements for
the prescriptive use of respiratory protection for these conditions of
use as listed in Unit IV.A.4.
55. In Unit V.A.1., EPA is requesting comment on whether preventing
dermal contact with NMP through dermal PPE, training, and a
concentration limit would adequately address the unreasonable risk from
dermal exposures for these industrial and commercial use.
56. In Unit V.A.2., EPA is considering and requesting comment on an
NMP WCPP--including requirements to prevent direct dermal contact--for
some conditions of use of NMP that would be prohibited or otherwise
regulated under the proposed regulatory action.
57. Unit V.A.2., EPA is requesting comment on the alternative
regulatory action and in particular the likelihood of successful
compliance with an NMP WCPP, as described in Unit IV.A., for the
conditions of use listed for the alternative regulatory action of NMP
WCPP in Unit IV.B.
58. In Unit V.A.2., EPA is soliciting comment on prohibiting for
these occupational conditions of use.
59. In Unit V.A.3., EPA is requesting comment on whether to include
a self-certification requirement for purchasing NMP or NMP-containing
products.
60. In Unit V.A.3., EPA does not believe that biomonitoring methods
are standard procedures in most occupational uses and requests public
comment if these methods are viable to implement in the workplace.
61. In Unit V.B., EPA is soliciting comments on whether there are
products in use or available for sale relevant to these conditions of
use that contain NMP at this time, so that EPA can ascertain whether
there are alternatives that benefit human health or the environment as
compared to such use of NMP.
62. In Unit V.B., EPA is requesting comment on the Alternatives
Assessment as a whole.
63. In Unit VI.C., EPA requests comments from the public about the
importance of NMP in multiple existing product categories, including
the potentially increased future importance of NMP to innovation and as
an alternative.
64. In Unit VII.A., EPA is requesting public comment on the
sufficiency of an action taken under a Federal law not administered by
EPA.
65. In consideration of Panel report recommendations (Ref. 26) and
in response to input provided by SERs, EPA is requesting comment on the
following topics as outlined in the SBAR Panel Report:
EPA requests comment on whether to allow the use of NMP by
entities that could, based on demonstrated ability through
recordkeeping and utilization of a combination of controls (including
engineering controls, administrative controls, and PPE requirements),
eliminate direct dermal contact with NMP to address the unreasonable
risk.
EPA requests comment in the NPRM on reasonable compliance
timeframes for small businesses. Specifically, EPA requests comment on
whether and how to provide longer compliance timeframes for
transitioning to alternatives for uses requiring reformulation. As part
of this effort, EPA seeks comment on and consider compliance timelines
based on the expected availability of technically and economically
feasible alternatives, as well as any information that could be
provided based on requirements for certification or standards relevant
to pesticides, or as a solvent in products such as industrial cleaners,
paint strippers, and oil refining.
EPA request comments on differing compliance or reporting
requirements or timetables that account for the resources available to
small entities. Additionally, EPA seeks comment on reasonable
compliance timeframes for prohibitions or phase-outs on use of NMP in
chemical processing and formulation, in response to SER input and other
appropriate factors, such as the lifespan of equipment, capital costs
for new equipment and certification, time to research alternatives, and
time to reformulate products. In addition, EPA requests comment on any
additional appropriate factors for identifying reasonable compliance
timeframes and how to weigh the factors for chemical processing,
agricultural product manufacturing, petrochemical refining, and other
industries.
EPA requests comment in the NPRM on a de minimis level in
the case of an impurity or trace amounts of NMP in products.
EPA requests comment on whether any chemicals identified
by the Agency as part of the TSCA risk evaluation process as presenting
an unreasonable risk of injury to health or the environment as well as
chemicals undergoing risk evaluation would be likely to be considered
as viable alternatives and, if so, in which circumstances.
EPA requests comment on a regulatory approach for those
conditions of use where EPA has confidence that exposures to NMP can be
effectively controlled, would provide flexibility for regulated
entities to incorporate the hierarchy of controls and reduce exposures
so that the unreasonable risk is no longer present.
EPA seeks comment on state of the art equipment,
engineering and administrative controls, and monitoring for dermal
exposures.
EPA requests public comment on a limited access program
for the sale of products containing NMP that could require training and
certification or restrict distribution only to users with certain
equipment that could reduce or eliminate dermal exposures or type of
facilities.
IX. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Risk Evaluation n-Methylpyrrolidone. December 2020.
2. EPA. Final Revised Unreasonable Risk Determination for n-
Methylpyrrolidone, Section 5. December 2022.
3. EPA. n-Methylpyrrolidone (NMP); Revision to Toxic Substances
Control Act (TSCA) Risk Determination; Notice of Availability.
Federal Register. 87 FR 242, December 19, 2022 (FRL-9943-02-OCSPP).
4. EPA. Alternatives Assessment for Use of n-Methylpyrrolidone.
September 2023.
5. EPA. Economic Analysis of the Proposed Regulation of N-
Methylpyrrolidone. May 2024.
6. EPA. Chemical Data Reporting. 2020. https://www.epa.gov/chemical-data-reporting/access-cdr-data.
7. EPA. Regulatory Actions Pertaining to N-Methylpyrrolidone. May
2024.
[[Page 51181]]
8. NIOSH. Hierarchy of Controls. Last Reviewed January 17, 2023.
https://www.cdc.gov/niosh/topics/hierarchy/.
9. Solomon et al. 1-methyl-2-pyrrolidone (NMP): Reproductive and
developmental toxicity study by inhalation in the rat. http://dx.doi.org/10.3109/01480549509014324.
10. The American Industrial Hygiene Association (AIHA). OARS WEEL
Table. https://www.tera.org/OARS/#reservations.
11. Saillenfait et al. Developmental toxicity of N-methyl-2-
pyrrolidone in rats following inhalation exposure. http://dx.doi.org/10.1016/S0278-6915(02)00300-9.
12. Exxon Biomedical Sciences. Multigeneration Rat Reproduction
Study with n-Methylpyrrolidone, Project Number 236535.
13. European Union. Regulations. April 18, 2018.
14. Lee et al. Toxicity of N-methyl-2-pyrrolidone (NMP):
Teratogenic, subchronic, and two-year inhalation studies. http://dx.doi.org/10.1016/0272-0590(87)90045-5.
15. EPA. Memorandum of n-Methylpyrrolidone (NMP): Fenceline
Technical Support--Ambient Air Pathway.
16. EPA. Memorandum of n-Methylpyrrolidone (NMP): Fenceline
Technical Support--Water Pathway. July 17, 2023.
17. EPA. TSCA Work Plan Chemical Risk Assessment N-
Methylpyrrolidone: Paint Stripper Use. March 2015.
18. Executive Order 13985. Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government. Federal
Register. 86 FR 7009, January 20, 2021.
19. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register. 86 FR 7037, January 25, 2021.
20. Executive Order 14008. Tackling the Climate Crisis at Home and
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
21. EPA. EPA Announces Path Forward for TSCA Chemical Risk
Evaluations. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
22. EPA. Science Advisory Committee on Chemicals Meeting Minutes and
Final Report No. 2022-01. March 15-17, 2022. https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0415-0095.
23. EPA. Notes from Federalism Consultation on Forthcoming Proposed
Rulemakings for Trichloroethylene, Perchloroethylene, and n-
Methylpyrrolidone under TSCA Section 6(a). July 22, 2021.
24. EPA. Notes from Tribal Consultations on Forthcoming Proposed
Rulemakings for n-Methylpyrrolidone.
25. EPA. Notes from Environmental Justice Consultations on
Forthcoming Proposed Rulemakings for n-Methylpyrrolidone (NMP). July
7 and July 13, 2021.
26. Small Business Advocacy Review. Final Report of the Small
Business Advocacy Review Panel on EPA's Planned Proposed Rule for n-
Methylpyrrolidone (NMP).
27. EPA. Initial Regulatory Flexibility Analysis (IRFA) for Proposed
Regulation of n-Methylpyrrolidone. May 2024.
28. EPA. Public Webinar on n-Methylpyrrolidone (NMP): Risk
Evaluation and Risk Management under TSCA Section 6. February 24,
2021.
29. EPA. Stakeholder Meeting List for Proposed Rulemaking for N-
Methylpyrrolidone under TSCA Section 6(a).
30. EPA. 2021 Policy on Children's Health. October 5, 2021.
31. EPA. Instructions for Reporting 2020 TSCA Chemical Data
Reporting. May 2020.
32. EPA. Revised Titles for the NMP Conditions of Use from the Final
Risk Evaluation.
33. EPA. Problem Formulation of the Risk Evaluation for N-
Methylpyrrolidone. May 2018.
34. EPA. Supplemental Information on Occupational Exposure
Assessment. December 2020.
35. OSHA. Recommended Practices for Safety and Health Programs.
October 2016. https://www.osha.gov/safety-management.
36. OSHA. Personal Protective Equipment. 2004. https://www.osha.gov/sites/default/files/publications/osha3151.pdf.
37. EPA. NMP Supplemental File with Additional Occupational PBPK
Runs. December 2023.
38. EPA. Supplemental Data File of Results of Additional Consumer
PBPK Runs.
39. DuPont. Meeting with DuPont on NMP Risk Evaluation/Risk
Management. September 13, 2023.
40. European Commission. Regulation (EC) No 1907/2006. December 18,
2006.
41. EPA. Supplemental Data File of Results of NMP Air Concentration
and Weight Fraction Modeling.
42. Semiconductor Industry Association (SIA). Comments of the
Semiconductor Industry Association (SIA) on the Draft Toxic
Substances Control Act (TSCA) Risk Evaluation for N-
Methylpyrrolidone (NMP). January 21, 2020.
43. EPA. Meeting with Celanese on Risk Management under TSCA Section
6 for n-Methylpyrrolidone. March 9, 2021.
44. Lithium Ion Cell Manufacturers' Coalition (LICMC).
Correspondence from the Lithium Ion Cell Manufacturers' Coalition on
Risk Management for n-Methyl pyrrolidone (NMP). September 22, 2023.
45. NASA. NASA--Known Uses of n-Methylpyrrolidone. October 17, 2023.
46. EPA. Methylene Chloride and N-Methylpyrrolidone; Regulation of
Certain Uses Under TSCA Section 6(a); Proposed Rule.Federal
Register. 82 FR 12, January 19, 2017 (FRL-9958-57).
47. EPA. Withdrawal of Proposed Rules; Discontinuing Three
Rulemaking Efforts Listed in the Semiannual Regulatory Agenda.
Federal Register. 86 FR 10, January 15, 2021 (FRL-10018-67).
48. EPA. Recommendation for an Existing Chemical Exposure
Concentration Limit (ECEL) for Occupational Use of N-
Methylpyrrolidone (NMP) and Workplace Air Monitoring Methods for NMP
[RIN 2070-AK07]. January 2017.
49. OSHA. 29 CFR 1910.1028 Benzene. September 27, 2023.
50. OSHA. 29 CFR 1910.1027 Cadmium. September 27, 2023.
51. OSHA. 29 CFR 1910.1025 Lead. September 27, 2023.
52. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Regulation of n-
Methylpyrrolidone under TSCA Section 6(a).
53. U.S. Consumer Product Safety Commission. What You Should Know
About Using Paint Strippers.
54. OMB. Guidance for Implementing Title II of [UMRA]. March 31,
1995.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is a ``significant regulatory action,'' as defined
under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4,
1993), as amended by Executive Order 14094 (88 FR 21879, April 11,
2023). Accordingly, EPA submitted this action to OMB for Executive
Order 12866 review. Documentation of any changes made in response to
the Executive Order 12866 review is available in the docket. EPA
prepared an analysis of the potential costs and benefits associated
with this action. This analysis (Ref. 5) is also available in the
docket and is summarized in Unit VI.D.2.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted to OMB for review and comment under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 2786.01 (Ref. 52). You can find
a copy of the ICR in the docket for this rule, and it is briefly
summarized here.
There are two primary provisions of the proposed rule that may
increase burden under the PRA. The first is downstream notification,
which would be carried out by updates to the relevant SDS and which
would be required for manufacturers, processors, and distributors in
commerce of NMP, who would provide notice to companies
[[Page 51182]]
downstream upon shipment of NMP about the prohibitions. The information
submitted to downstream companies through the SDS would provide
knowledge and awareness of the restrictions to these companies. The
second is WCPP-related information generation, recordkeeping, and
notification requirements (including development of exposure control
plans and related recordkeeping; development of documentation for a PPE
program and related recordkeeping; development and notification to
potentially exposed persons (employees and others in the workplace)
about how they can access the exposure control plans, PPE program
implementation documentation including glove testing; and development
of self-certification documentation demonstrating eligibility for the
WCPP if relevant, and related recordkeeping).
Respondents/affected entities: Persons that manufacture, process,
use, distribute in commerce, or dispose of NMP or products containing
NMP. See also Unit I.A.
Respondent's obligation to respond: Mandatory (TSCA section 6(a)
and 40 CFR part 751).
Estimated number of respondents: 63,749.
Frequency of response: On occasion.
Total estimated burden: 189,534 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $219,812,949 (per year), includes
$206,079,628 annualized capital or operation and maintenance costs,
specifically glove testing.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. After display in the Federal
Register when approved, the OMB control numbers for certain EPA
regulations in title 40 of the CFR are listed in 40 CFR part 9 and
displayed on the form and instructions or collection portal, as
applicable.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this proposed rule. You may also send your ICR-
related comments to OMB's Office of Information and Regulatory Affairs
using the interface at https://www.reginfo.gov/public/do/PRAMain. Find
this particular ICR by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. OMB must receive
comments no later than July 15, 2024. EPA will respond to ICR-related
comments in the final rule.
C. Regulatory Flexibility Act (RFA)
As required by section 609(b) of the RFA, the EPA convened a SBAR
Panel to obtain advice and recommendations from SERs that potentially
would be subject to the rule's requirements. The SBAR Panel evaluated
the assembled materials and small-entity comments on issues related to
elements of an IRFA. Prior to convening the Panel, EPA conducted
outreach and solicited comments from the SERs. After the Panel was
convened, the Panel provided additional information to the SERs and
requested their input. SERs involved in the consultation included
industries that manufacture fertilizer and other agricultural chemical
manufacturing, chemical processors (including oil re-refiners), and
formulators of paint and coating removal products. The Panel identified
several significant uses of NMP and detailed workplace safety
operations for consideration by the Administrator of the EPA that
support the stated objectives of TSCA section 6 and minimize impacts of
the proposed rule on small entities. The Panel recommended several
exposure and reduction practices, including specific engineering and
administrative controls and PPE, reviewed information about alternative
chemicals, and discussed the regulation of NMP under FIFRA. EPA is
including these considerations for the proposed rule and is soliciting
comment on others. The report was finalized and transmitted to the EPA
Administrator for consideration. A copy of the full SBAR Panel Report
is available in the rulemaking docket, including SERs involved,
materials presented to SERs, and recommendations. Pursuant to section
603 of the RFA, 5 U.S.C. 601 et seq., EPA prepared an initial
regulatory flexibility analysis (IRFA) (Ref. 27) that examines the
impact of the proposed rule on small entities along with regulatory
alternatives that could minimize that impact. The complete IRFA is
available for review in the docket and is summarized here.
1. Need for the Rule
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
after a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other nonrisk factors, including an
unreasonable risk to a PESS identified as relevant to the risk
evaluation, under the conditions of use, EPA must by rule apply one or
more requirements listed in TSCA section 6(a) to the extent necessary
so that the chemical substance or mixture no longer presents such risk.
NMP was the subject of a risk evaluation under TSCA section 6(b)(4)(A)
that was issued in December 2020. In addition, in December 2022, EPA
issued a revised unreasonable risk determination that NMP as a whole
chemical substance presents an unreasonable risk of injury to health
under the conditions of use. As a result, EPA is proposing to take
action to the extent necessary so that NMP no longer presents such
risk.
2. Objectives and Legal Basis
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk. EPA has determined through a TSCA section
6(b) risk evaluation that NMP presents an unreasonable risk under the
conditions of use.
3. Description and Number of Small Entities to Which the Rule Will
Apply
The proposed rule potentially affects small manufacturers
(including importers), processors, distributors, retailers, users of
NMP or of products containing NMP, and entities engaging in disposal.
EPA estimates that the proposal would affect approximately 61,851 small
entities. Most (39,215) of these entities are commercial users of NMP
in two sectors: fertilizer and other agricultural chemical
manufacturing and paints and coatings. EPA also estimates the uses with
the next largest numbers of small entities (20,962) using NMP include:
paint, coating, and adhesive removers; electronic product and
semiconductor manufacturing; waste handling, disposal, treatment, and
recycling; adhesives and sealants; cleaning and furniture care
products; and soldering.
4. Projected Compliance Requirements
To address the unreasonable risk EPA has identified, EPA is
proposing to: prohibit the manufacture (including import), processing,
distribution in commerce, and use of NMP for several occupational
conditions of use. To address the unreasonable risk to workers, EPA is
also proposing to require container size limits and labeling
requirements for the import, processing, and distribution in commerce
of NMP products for several
[[Page 51183]]
consumer uses, to prevent diversion to commercial uses. For most other
conditions of use that contribute to the unreasonable risk
determination for NMP, EPA proposes to address the unreasonable risk
with an NMP WCPP, which would include a combination of requirements
including to prevent direct dermal contact with NMP. As described in
Unit IV.A., the NMP WCPP would be non-prescriptive, in the sense that
regulated entities would not be required to use specific controls
prescribed by EPA to achieve the restrictions. The NMP WCPP would
encompass restrictions on most occupational conditions of use and could
include provisions for DDCC and ancillary requirements to support
implementation of these restrictions. While the NMP WCPP includes
stringent requirements that would be necessary to address the
unreasonable risk from NMP, because the dermal exposures can be more
effectively controlled in a broad range of facilities engaging in a
relatively large number of conditions of use, EPA identified a
relatively large number of conditions of use where the Agency expected,
based on reasonably available information, an NMP WCPP could be
successfully implemented. EPA is also proposing to require prescriptive
controls, including concentration limits and PPE, for additional
occupational conditions of use, instead of requirements for WCPP.
To address unreasonable risks to consumers, EPA proposes to require
a concentration limit on NMP for the manufacture (including import),
processing, and distribution in commerce of one consumer use.
Regarding recordkeeping requirements, three primary provisions of
the proposed rule relate to recordkeeping. The first is recordkeeping
of general records: all persons who manufacture, process, distribute in
commerce, or engage in industrial or commercial use of NMP or NMP-
containing products must maintain ordinary business records, such as
invoices and bills-of-lading related to compliance with the
prohibitions, restrictions, and other provisions of the regulation.
The second is recordkeeping related to WCPP compliance: under the
proposed regulatory action, facilities complying with the rulemaking
through WCPP would be required to develop and maintain records
associated with DDCC compliance (including the exposure control plan,
PPE program implementation, basis for specific PPE selection,
occurrence and duration of direct dermal contact with NMP, and
workplace information and training); and workplace participation. To
support and demonstrate compliance, EPA is proposing that each owner or
operator of a workplace subject to the WCPP retain compliance records
for five years.
Third, EPA is also proposing to require specific prescriptive
controls for a few occupational conditions of use of NMP, to restrict
the concentration limit and require PPE as detailed in Unit IV.A.3. for
imported formulations, processing, distribution in commerce, and use of
NMP in those conditions of use. EPA is also proposing to restrict the
import, processing, distribution in commerce of NMP for one consumer
use in concentrations greater than those specified in Unit III.A.3.c.
To support and demonstrate compliance, EPA is proposing that each owner
or operator of a workplace subject to the prescriptive controls
requirements retain compliance records for five years.
Regarding third-party notification, EPA is not proposing reporting
requirements beyond downstream notification, labeling, and self-
certification for entities using NMP under the narrowly-applied WCPP
for certain uses.
Downstream notification: To ensure compliance with downstream
notification for WCPP EPA is proposing that manufacturers (including
importers), processors, and distributors, excluding retailers, of NMP
and NMP-containing products provide downstream notification of the
prohibitions through the SDS required by OSHA under 29 CFR 1910.1200(g)
by adding language as described in Unit IV.A.7.
Labeling: To ensure compliance with the container size restrictions
for the products of the uses listed in Unit IV.A.2 EPA is proposing
require products to be labeled with the prescribed text in Unit IV.A.2.
Self-Certification-Related Information Generation, Recordkeeping, and
Notification Requirements
EPA has authority under section 6 of TSCA to require recordkeeping
related to the regulatory requirements imposed by EPA. This is
especially important where, as here, such records are needed for
effective implementation and enforcement of the TSCA section 6 rule to
eliminate unreasonable risk. The self-certification would provide
potentially exposed persons in a workplace with clear and necessary
information and would provide EPA with a necessary evidence mechanism
for effective enforcement. The regulated entities would develop,
compile, and retain records that are necessary for self-certification
compliance, provide workplace notification to potentially exposed
persons, and serve as a reference for EPA or authorized entities. These
records include a self-certification statement and all records as
required by the NMP WCPP.
a. Classes of Small Entities Subject to the Compliance Requirements
The small entities that would be potentially directly regulated by
this rulemaking are small entities that manufacture (including import),
process, distribute in commerce, use, or dispose of NMP, including
retailers of NMP for end-consumer uses.
b. Professional Skills Needed To Comply
Entities that would be subject to this proposal that manufacture
(including import), process, or distribute NMP in commerce would be
required to modify their SDS or develop another way to inform their
customers of the prohibitions and requirements for WCPP. Some entities
would also be required to update product labels or containers. They
would also be required to maintain ordinary business records, such as
invoices and bills-of-lading, that demonstrate compliance with the
prohibitions, restrictions, and other provisions of this proposed
regulation. These are all routine business tasks that do not require
specialized skills or training.
Entities that use NMP in any industrial and commercial capacity
that is prohibited would be required to cease under the proposed rule.
While this would not require any special skills, the implementation of
an alternative chemical or the cessation of use of NMP in a process or
equipment may require persons with specialized skills, such as
engineers or other technical experts. Instead of developing an
alternative method themselves, commercial users of NMP may choose to
contract with another entity to do so.
Entities that would be permitted to continue to manufacture,
process, distribute, use or dispose of NMP would be required to
implement a WCPP and would have to meet the provisions of the program
for continued use of NMP. Entities that would be permitted to continue
use of NMP in the uses listed in Unit IV.A.4 would be required to
implement prescriptive controls, including concentration limits and PPE
program restrictions for continued use of NMP. A transition to a WCPP
or prescriptive controls may require persons with specialized skills
such as an engineer or health and safety professional. Instead of
implementing the WCPP or prescriptive controls for
[[Page 51184]]
themselves, entities that use NMP may choose to contract with another
entity to do so. Records would have to be maintained for compliance
with a WCPP or prescriptive controls, as applicable. While this
recording activity itself may not require a special skill, the
information to be measured and recorded may require persons with
specialized skills such as an industrial hygienist.
5. Relevant Federal Rules
Because of its health effects, NMP is subject to some Federal laws
and regulations in the United States and is also subject to regulation
by some states and other countries. The following is a summary of the
regulatory actions pertaining to NMP; for a full description, see
appendix A of the 2020 Risk Evaluation for NMP and the summary in the
docket (Ref. 7).
NMP is listed on the Toxics Release Inventory (TRI) pursuant to
section 313 of the Emergency Planning and Community Right-to-Know Act
(EPCRA). NMP is regulated on the Federal Food, Drug, and Cosmetic Act
(FFDCA) under FFDCA section 408 NMP is currently approved for use as a
solvent and co-solvent inert ingredient in pesticide formulations for
both food and non-food uses and is exempt from the requirements of a
tolerance limit (40 CFR part 180.920). Under the Clean Air Act (CAA)
section 183(e) and section 111(b) NMP is subject to several reporting
standards and is listed on the Equipment Leaks Chemical List (40 CFR
68.130).
In addition to regulations administered by EPA, NMP is also subject
to other Federal regulations. The Consumer Product Safety Commission
(CPSC) issued a fact sheet in 2013, warning the public about hazards of
paint and coating removal products, including those containing NMP. The
fact sheet included recommendations for PPE when using products
containing NMP (Ref. 53). The U.S. Food and Drug Administration (FDA)
identifies NMP as an ``Indirect Additive Used in Food Contact
Substances'' and as a Class 2 solvent, namely a solvent that ``should
be limited in pharmaceutical products because of their inherent
toxicity.'' FDA established a Permissible Daily Exposure (PDE) for NMP
of 5.3 mg/day with a concentration limit of 530 ppm, and its Center for
Veterinary Medicine developed a method in 2011 for detection of the
residues of NMP in edible tissues of cattle (21 CFR 500.1410).
When meeting certain combustibility criteria (i.e., boiling point
less than 200 [deg]F), NMP may be regulated as a hazardous material by
the U.S. Department of Transportation (DOT) when transported by
highway, rail, vessel, or air. As such, transporting NMP may be subject
to certain requirements under Section 5103 of the Federal Hazardous
Material Transportation Act (49 U.S.C. 5103) and the Hazardous
Materials Regulations (HMR; 49 CFR parts 171 through 180), such as
shipping papers, marking, labeling, placarding, etc.
State actions pertaining to NMP include listing NMP in state air
regulations. New Hampshire lists NMP as a regulated toxic air pollutant
(Env-A 1400: Regulated Toxic Air Pollutants) and Vermont lists NMP as a
hazardous air contaminant (Vermont air Pollution Control Regulations,
5261). California has a PEL for NMP of 1 part per million (ppm) as an
8-hr-time-weighted average (TWA) along with a skin notation for NMP
(California Code of Regulations, title 8, section 5155). California
also lists NMP on Proposition 65 due to reproductive toxicity (Cal.
Code Regs. Title 27, Section 27001). California's Office of
Environmental Health Hazard Assessment (OEHHA) lists a Maximum
Allowable Dose Level (MADL) for inhalation exposure = 3,200 micrograms
per day ([mu]g/day) and MADL for dermal exposure = 17,000 [mu]g/day.
The California Department of Toxic Substances Control (DTSC) Safer
Consumer Products Program lists NMP as a Candidate Chemical for
development toxicity and reproductive toxicity. Several other states
have adopted reporting laws for chemicals in children's products that
include NMP. Minnesota has listed NMP as a chemical of concern to
children (Minnesota Statutes 116.9401 to 116.9407).
International actions pertaining to NMP include the listing, in
2011, of NMP on the Candidate list as a Substance of Very High Concern
(SVHC) under regulation (EC) No 1907/2006 to the Regulation,
Evaluation, Authorisation and Restriction of Chemicals (REACH). In 2018
the European Union added NMP to REACH Annex XVII, the restricted
substances list. The restriction includes three conditions: that NMP
shall not be placed on the market above 0.3% unless users have chemical
safety reports and SDSs with set inhalation and dermal Derived No-
Effect Levels (DNELs); NMP shall not be used above 0.3% unless
appropriate risk management measures ensure that the exposure of
workers is below the DNELs; and an exclusion from the regulation until
May 9, 2024, for the use of NMP as a solvent or reactant in the process
of coating wires. Several countries, including Australia, Belgium,
Canada, Finland, Poland, and Spain have occupational exposure limits
(OELs) for NMP (GESTIS International limit values for chemical agents
OELs database, Accessed April 12, 2023).
6. Significant Alternatives to the Proposed Rule
EPA analyzed alternative regulatory approaches to identify which
would be feasible, reduce burden to small businesses, and achieve the
objective of the statute (i.e., applying one or more requirements
listed in TSCA section 6(a) to the extent necessary so that the
chemical substance or mixture no longer presents an unreasonable risk).
As described in more detail in Unit V., EPA considered several factors,
in addition to identified unreasonable risk, when selecting among
possible TSCA section 6(a) requirements. To the extent practicable, EPA
factored into its decisions: the effects of NMP on health and the
environment, the magnitude of exposure to NMP of human beings and the
environment, the benefits of NMP for various uses, and the reasonably
ascertainable economic consequences of the rule. As part of this
analysis, EPA considered--in addition to the proposed regulatory action
described in Unit IV--a wide variety of control measures to address
unreasonable risk from NMP such as point-of-sale self-certification,
inhalation or dermal exposure limits, and weight fraction limits. EPA's
analysis of these risk management approaches (as well as additional
approaches) is detailed in Unit V.A.3. In general, EPA determined that
these approaches alone would not be able to address the unreasonable
risk. More detail is provided in this Unit and in Unit V.A.3.
Point-of-sale self-certification: As discussed in Unit V.A.3, EPA
also examined the extent to which a point-of-sale self-certification
requirement in order to purchase and subsequently use NMP would further
ensure that only facilities able to implement and comply with a WCPP or
prescriptive controls are able to purchase and use NMP, and self-
certify to that. Under a self-certification requirement, entities would
submit a self-certification to the distributor each time NMP is
purchased. The self-certification would consist of a statement
indicating that the facility is implementing a WCPP or required
prescriptive controls to control exposures to NMP; the self-
certification would be signed and presented by a person authorized to
do so by the facility owner or operator. Copies of the self-
certification would be maintained as records by both the owner or
operator
[[Page 51185]]
and the distributor where NMP was purchased. While EPA is proposing to
include a requirement for self-certification as part of the narrow
application of the WCPP for two commercial uses of NMP in paints and
coatings and paint, coating, and adhesive removers for DOD, NASA, and
their contractors, that narrowly tailored self-certification differs
from a broader point-of-sale self-certification requirement that would
be applicable to all commercial users of products containing NMP. The
self-certification proposed relies on the adherence of a narrowly-
defined, highly regulated group of users (DOD, NASA, or their
contractors) performing work at clearly defined facilities for specific
purposes on mission- or safety-critical components in compliance with
the WCPP requirements described in Unit IV.A.3.
In contrast, a broader self-certification requirement would place
requirements on large and diverse groups of users and distributors.
Because of the number and types of entities where users can obtain NMP
or NMP-containing products, EPA does not believe the added requirement
and subsequent burden of a point-of-sale self-certification requirement
for the use of NMP would be an effective tool for preventing facilities
that may be unable to comply with the WCPP or prescriptive controls of
this proposed rulemaking from accessing NMP or NMP-containing products.
As such, EPA is not proposing a self-certification requirement as an
additional component of the requirements for addressing the
unreasonable risk of occupational exposures to NMP.
Inhalation or dermal exposure limit: As discussed in Unit III.B.2,
the 2020 Risk Evaluation for NMP assessed exposure from inhalation,
dermal, and vapor through skin exposure, and identified that the
unreasonable risk of injury to human health is mainly driven by direct
dermal contact with NMP. EPA identified that the best representative
endpoints for non-cancer effects were from acute (developmental
toxicity) and chronic (reproductive toxicity) exposures for all
conditions of use. Additional risks associated with other adverse
effects (e.g., liver toxicity, kidney toxicity, immunotoxicity,
neurotoxicity, irritation and sensitization) were identified.
Therefore, EPA is proposing dermal exposure controls (or, as needed,
prohibitions) to prevent direct dermal contact with NMP. While
inhalation risks contribute to the unreasonable risk from NMP,
addressing inhalation risks alone would not mitigate the unreasonable
risk from NMP. As discussed in Unit V.A.3 of the proposed rule, EPA
also examined the extent to which setting an Existing Chemical Exposure
Limit (ECEL) or a dermal exposure limit as a regulatory action would
address the unreasonable risk by inhalation and dermal exposures. EPA
is not proposing an ECEL because the unreasonable risk to workers from
NMP is driven by dermal exposures, and an ECEL would only address risk
from inhalation and vapor-through-skin (dermal exposure to vapor but
not direct dermal contact with a liquid) exposures. Therefore,
requirements to meet an ECEL would not address the unreasonable risk
from dermal exposure. EPA is also not proposing an existing chemical
dermal exposure limit because biomonitoring methods, such as blood
concentration testing or urine analysis to measure compliance to a
dermal exposure limit, may not be readily available or feasible for
most workplaces to implement. EPA does not believe that biomonitoring
methods are standard procedures in most occupational uses. As such, EPA
is not proposing an inhalation or dermal exposure requirement for
addressing the unreasonable risk of occupational exposures to NMP.
Weight fraction limit: To address the unreasonable risk, EPA also
considered limiting the weight fraction of NMP in products and
formulations without requirements for dermal or respiratory PPE. As
described in Unit V.A.1.a., EPA determined that the unreasonable risk
from NMP would not be contributed to by use of products containing NMP
at less than 0.1% by weight. However, for all industrial/commercial and
consumer conditions of use, the concentration limit of 0.1% is so low
that it is highly unlikely that NMP would still serve its functional
purpose in the product or formulation. EPA thus concluded that a weight
fraction restriction without accompanying PPE requirements would
essentially function as a prohibition. for the conditions of use listed
in Unit IV.A.2, and EPA therefore did not propose a weight fraction for
those occupational conditions of use. EPA is however proposing a de
minimis level for products containing NMP at levels of less than 0.1%
to account for impurities that do not contribute to the unreasonable
risk., as described in Unit IV.A.1.b.
Additionally, in the proposed rule preamble and the Economic
Analysis, EPA has examined a primary alternative regulatory action. The
primary alternative regulatory action described in this proposed rule
and considered by EPA combines prohibitions and requirements for a
WCPP. While in some ways it is similar to the proposed regulatory
action, the primary alternative regulatory action described in this
proposed rule differs from the proposed regulatory action by providing
for a WCPP, including DDCC, for some conditions of use that would be
prohibited or have prescriptive controls under the proposed regulatory
action. Additionally, the primary alternative regulatory action
includes prohibitions for one industrial and commercial use and the
manufacturing, processing, and distribution in commerce for one
consumer use; all of which would be required to have prescriptive
controls under the proposed regulatory action. The primary alternative
regulatory action would not include restrictions on the container size
of consumer products that may feasibly be used for commercial purposes.
In its review of alternatives, EPA determined that some methods either
did not effectively address the unreasonable risk presented by NMP or
there was uncertainty about whether facilities in conditions of use
would be able to comply with a comprehensive WCPP to adequately protect
potentially exposed persons. While EPA is soliciting comments about all
aspects on each of the alternative regulatory actions, which may be
incorporated into the final rulemaking, EPA has considered the primary
alternative regulatory actions and found that the proposed action is
more suitable for addressing the unreasonable risk to the extent
necessary so that NMP no longer presents such risk, while also allowing
flexibility for regulated entities to continue operations, as described
in more detail in Unit IV.A. and V.A. Estimated costs of the primary
alternative regulatory action can be found in chapter 7 of the Economic
Analysis (Ref. 5).
D. Unfunded Mandates Reform Act (UMRA)
This action contains a Federal mandate under UMRA, 2 U.S.C. 1531-
1538, that may result in expenditures of $100 million or more for
State, local and Tribal governments, in the aggregate, or the private
sector in any one year. Accordingly, the EPA has prepared a written
statement required under UMRA section 202 and section 205. The
statement is included in the docket for this action and is briefly
summarized here.
EPA estimated the compliance costs of the proposed rule to the
private sector to be approximately $396 million annualized over 20
years at a 3% discount rate and $397 million annualized over 20 years
at a 7% discount rate. However, the costs of the
[[Page 51186]]
rule to the private sector are difficult to completely quantify. It is
difficult to predict firm behavior in response to regulation in the
absence of firm specific revenue and cost and there are few sources
that provide direct estimates for number of firms using NMP. As
described in more detail in Units I.E. and VI.D.2. and Table 7-38 of
the Economic Analysis (Ref. 5), EPA estimated costs assuming all firms
using NMP comply with the proposed rule. Thus, the Agency concludes the
cost of the rule to the private sector may exceed the inflation-
adjusted UMRA threshold of $100 million in costs in any one year.
State, local, and Tribal governments are not expected to incur
large costs because of the proposed rule since they are not known to
engage in the manufacture, processing, distribution, or large-scale use
of NMP. Costs to State, local and Tribal governments from this proposed
rule would result from requirements related to disposal of NMP or
products containing NMP, which are estimated to be less than $8 million
annualized over 20 years at a 3% discount rate and 7% discount rate. In
addition, if State, local and Tribal governments engage in various
conditions of use of NMP for commercial use, they may need to switch to
different products that no longer contain NMP or change the types of
PPE workers wear when using NMP. EPA has identified many alternative
products currently available at comparable prices. Since there is not a
significant intergovernmental mandate, there is no need for Federal
financial assistance (e.g., grants or loans) or other Federal resources
from either EPA or other Federal agencies to assist state, local, or
Tribal governments in complying with the rule.
The rule's benefits include the prevention of the risk of numerous
adverse health effects from NMP exposure. In addition to EPA's 2020
Risk Evaluation for NMP, many authorities have determined acute
exposure to NMP may pose risks of developmental toxicity, notably
irreversible fetal death. NMP chronic exposure is known to present
risks of various non-cancer adverse health effects, including liver
toxicity, kidney toxicity, reduced male fertility and reduced female
fecundity impacts, and reproductive toxicity effects, notably low-birth
weight.
The economic impact of a regulation on the national economy is
generally considered to be measurable only if the economic impact of
the regulation reaches 0.25 percent to 0.5 percent of GDP (Ref. 54).
Given the current GDP of $23.17 trillion, this is equivalent to a cost
of $58 billion to $116 billion. Therefore, EPA has concluded that this
rulemaking is highly unlikely to have any measurable effect on the
national economy. Additional information on EPA's estimates of the
benefits and costs of this action are provided in Units I.E. and
VI.D.2. and in the Economic Analysis for this action (Ref. 5).
Information on the authorizing legislation is provided in Unit I.B.
Information on prior consultations with affected State, local, and
Tribal governments is provided in Unit III.A.1.
This action is not subject to the requirements of UMRA section 203
because it contains no regulatory requirements that might significantly
or uniquely affect small governments.
E. Executive Order 13132: Federalism
EPA has concluded that this action has federalism implications as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation of NMP under TSCA section 6(a) may preempt state
law. As set forth in TSCA section 18(a)(1)(B), the issuance of rules
under TSCA section 6(a) to address the unreasonable risk presented by a
chemical substance has the potential to trigger preemption of laws,
criminal penalties, or administrative actions by a state or political
subdivision of a state that are: (1) Applicable to the same chemical
substance as the rule under TSCA section 6(a); and (2) Designed to
prohibit or otherwise restrict the manufacture, processing, or
distribution in commerce or use of that same chemical. TSCA section
18(c)(3) applies that preemption only to the ``hazards, exposures,
risks, and uses or conditions of use'' of such chemical included in the
final TSCA section 6(a) rule.
EPA provides the following preliminary federalism summary impact
statement. The Agency consulted with state and local officials early in
the process of developing the proposed action to permit them to have
meaningful and timely input into its development. This included
background presentation on September 9, 2020, and a consultation
meeting on July 22, 2021. EPA invited the following national
organizations representing state and local elected officials to these
meetings: American Water Works Association, Association of Clean Water
Administrators, Association of Metropolitan Water Agencies, Association
of State Drinking Water Administrators, Environmental Council of the
States, National Association of Counties, National Conference of State
Legislatures, National Governors Association, National League of
Cities, National Water Resources Association, and United States
Conference of Mayors. During the consultation, stakeholders in
attendance recommended additional reporting requirements as a risk
management tool to address the unreasonable risk, suggested EPA look
into safer alternatives, and described concerns related to current
impacts on drinking water utilities from NMP (Ref. 23). A summary of
the meeting with these organizations, including the views that they
expressed, is available in the docket (Ref. 23). EPA provided an
opportunity for these organizations to provide follow-up comments in
writing but did not receive any such comments.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes. This rulemaking would not have
substantial direct effects on Tribal governments because NMP is not
manufactured, processed, or distributed in commerce by tribes. NMP is
not regulated by tribes, and this rulemaking would not impose
substantial direct compliance costs on Tribal governments. Thus,
Executive Order 13175 does not apply to this action.
Notwithstanding the lack of Tribal implications as specified by
Executive Order 13175, EPA met with Tribal representatives on this
action, consistent with the EPA Policy on Consultation and Coordination
with Indian Tribes, which EPA applies more broadly than Executive Order
13175. EPA scheduled consultations with representatives of Tribes via
webinar on June 14, 2021, and July 14, 2021, concerning the prospective
regulation of NMP under TSCA section 6(a). No attendance on June 14,
2020, resulted in the first scheduled consultation to be canceled.
Tribal officials were given the opportunity to meaningfully interact
with EPA risk managers concerning the current status of risk
management. During the consultation, EPA discussed risk management
under TSCA section 6(a), findings from the 2020 Risk Evaluation for
NMP, types of information to inform risk management, principles for
transparency during risk management, and types of information EPA is
seeking from Tribes (Ref. 24). EPA briefed Tribal officials on the
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Agency's risk management considerations and tribal officials raised no
related issues or concerns to EPA during or in follow-up to those
meetings (Ref. 24). Tribal members were encouraged to provide
additional comments after the teleconferences.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is subject to Executive Order 13045 (62 FR 19885, April
23, 1997) because it is a significant regulatory action under section
3(f)(1) of Executive Order 12866, and EPA believes that the
environmental health or safety risk addressed by this action has a
disproportionate effect on children due to reproductive and
developmental health effects associated with NMP exposure. Accordingly,
we have evaluated the environmental health effects of NMP exposure and
associated health impacts on children and adults of reproductive age.
For infants and males and females of reproductive age, EPA found
evidence of reproductive and developmental toxicity. The reproductive
and developmental health effects of concern related to exposures to NMP
are reduced male fertility and female fecundity and post-implantation
loss (resorptions and fetal mortality). The results of this evaluation
are in the 2020 Risk Evaluation for NMP (available in the public docket
for this action) and in Unit III.A.3 and Unit VI.A.
This proposed action is preferred over other regulatory options
analyzed because it will reduce to the greatest extent the exposure to
NMP for the general population and for potentially exposed or
susceptible subpopulations such as children and adults of reproductive
age through a combination of prohibition, and prescriptive and non-
prescriptive controls, including PPE use.
Furthermore, EPA's 2021 Policy on Children's Health also applies to
this action. Information on how the Policy was applied is discussed in
Unit III.A.3.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272., the Agency has
determined that this rulemaking involves environmental monitoring or
measurement, specifically for establishing that selected PPE would be
impervious for the expected duration and conditions of exposure to NMP.
Consistent with the Agency's Performance Based Measurement System
(PBMS), the Agency proposes not to require the use of specific,
prescribed analytic methods. Rather, the Agency plans to allow the use
of any method that meets the prescribed performance criteria. The PBMS
approach is intended to be more flexible and cost-effective for the
regulated community; it is also intended to encourage innovation in
analytical technology and improved data quality. EPA is not precluding
the use of any method, whether it constitutes a voluntary consensus
standard or not, as long as it meets the performance criteria
specified.
For this rulemaking, the key consideration for the PBMS approach is
the ability to accurately report cumulative permeation rate as a
function of time. Some examples of methods which meet the criteria are
included in appendix F of the 2020 Risk Evaluation (Ref. 1) and
described in Unit VI.A.3. EPA recognizes that there may be voluntary
consensus standards that meet the proposed criteria. EPA requests
comments on whether it should incorporate such voluntary consensus
standards in the rule and seeks information in support of such comments
regarding the availability and applicability of voluntary consensus
standards that may achieve the sampling and analytical requirements of
the rule in lieu of the PBMS approach.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that the human health or environmental conditions that
exist prior to this action result in or have the potential to result in
disproportionate and adverse human health or environmental effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023). As described more fully in the Economic
Analysis, EPA conducted an EJ analysis to characterize the baseline
conditions faced by communities and workers affected by the regulation
to identify the potential for disproportionate impacts on various
communities. Informed by the fenceline analysis referenced in Unit
VI.A., exposure to NMP is primarily experienced by consumers using NMP-
containing products and workers and occupational non-users directly on
site. The baseline characterization suggests residents of nearby
communities within one mile and three miles are more likely to be
People of Color and low-income relative to the general population in
affected locations. Workers in the industries assessed, including
industrial and miscellaneous chemical and paint, coating and adhesives,
are less likely to be People of Color and low-income when analyzed
using national industry data; however, local variation is obscured and
the use of county-industry data suggests workers in affected counties
with basic chemical manufacturing NMP facilities have larger
representation of non-White, including Hispanic, workers and female
workers ages 25-44. There is possible aggregate exposure concern for
nearby communities given clustering of NMP facilities relative to other
NMP facilities and possible cumulative exposure concern with nearby
clustered TRI facilities that may also release or use other chemicals.
Other indicators of cumulative concern include elevated cancer risk and
PM 2.5 values for nearby communities one mile and three miles away from
NMP facilities. Communities also exhibited slightly elevated perinatal
mortality and very low birthweight rates, health end points of concern
from NMP exposure. Note, these are indicators and not precise measures
of actual risk and data limitations restrict the ability to causally
link these health end points to specific facilities or workers (Ref.
1).
EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on communities with EJ concerns.
While the regulatory options are anticipated to address the
unreasonable risk from exposure to NMP to the extent necessary so that
it is no longer unreasonable, EPA is not able to quantify the
distribution of the change in risk across affected workers,
communities, or demographic groups. EPA is also unable to quantify the
changes in risks to workers, communities, and demographic groups from
non-NMP-using technologies or practices that firms may adopt in
response to the regulation to determine whether any such changes could
pose EJ
[[Page 51188]]
concerns. Data limitations that prevent EPA from conducting a more
comprehensive analysis are summarized in the Economic Analysis (Ref.
5).
EPA additionally identified and addressed EJ concerns by conducting
outreach to advocates in affected communities that might be subject to
disproportionate exposure to NMP. On July 7, 2021, and July 13, 2021,
EPA held public meetings as part of this consultation (Ref. 25). See
also Unit III.A.1. These meetings were held pursuant to Executive Order
12898 and Executive Order 14008, entitled ``Tackling the Climate Crisis
at Home and Abroad'' (86 FR 7619, February 1, 2021).
Following the EJ meetings, EPA received one written comment, in
addition to oral comments provided during the consultations. In
general, commenters supported strong outreach to affected communities,
encouraged EPA to follow the hierarchy of controls, favored
prohibitions, and noted the uncertainty, and in some cases inadequacy,
of PPE. Other commenters asked about the Agency's schedule for a
proposed rule while reconsidering certain aspects of the 2020 Risk
Evaluation. Additionally, commenters expressed concern that the adverse
health impacts of NMP, particularly to pregnant people and children and
urged EPA to ban the use of NMP in paint and coating removers, for the
reasons discussed in this unit EPA is not proposing this ban (Ref. 25).
The information supporting this Executive Order review is contained
in Units I.E., II.D., III.A.1., VI.A., and in the Economic Analysis
(Ref. 5). EPA's presentations and fact sheets for the EJ consultations
related to this rulemaking, are available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/materials-june-and-july-2021-environmental-justice. These materials and a summary of the
consultation are also available in the public docket for this
rulemaking (Ref. 25).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export Notification, Hazardous
substances, Import certification, Reporting and recordkeeping.
Michael S. Regan,
Administrator.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 751 as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 continues to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Amend Sec. 751.5 by adding in alphabetical order definitions for
``Direct dermal contact'', ``Exposure group'', and ``Restricted area''
to read as follows:
Sec. 751.5 Definitions.
* * * * *
Direct dermal contact means direct handling of a chemical substance
or mixture or skin contact with surfaces that may be contaminated with
a chemical substance or mixture.
* * * * *
Exposure group means a group consisting of every person performing
the same or substantially similar operations in each work shift, in
each job classification, in each work area where exposure to chemical
substances or mixtures is reasonably likely to occur.
* * * * *
Restricted area means an area established by the regulated entity
to demarcate areas where direct dermal contact with a specific chemical
substance may occur.
* * * * *
0
3. Add subpart C to read as follows:
Subpart C--n-Methylpyrrolidone
Sec.
751.201 General.
751.203 Definitions.
751.205 Prohibitions of manufacturing, processing, distribution in
commerce, and use.
751.207 Concentration limits, container size limits, and labels
751.209 Workplace Chemical Protection Program.
751.211 Prescriptive workplace requirements.
751.213 Recordkeeping requirements.
751.215 Downstream notification.
751.217 Mission- or safety-critical uses of paint, coating, or
adhesive removers or paints and coatings.
Subpart C--n-Methylpyrrolidone (NMP)
Sec. 751.201 General.
(a) Applicability. This subpart establishes prohibitions and
restrictions on the manufacture (including import), processing,
distribution in commerce, use, and disposal of n-methylpyrrolidone
(CASRN 872-50-4) (NMP), to prevent unreasonable risks of injury to
health in accordance with TSCA section 6(a).
(b) De minimis level. Unless otherwise specified in this subpart
prohibitions and restrictions of this subpart do not apply to products
containing NMP at levels less than 0.1 percent by weight.
Sec. 751.203 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. 751.213.
Sec. 751.205 Prohibitions of manufacturing, processing, distribution
in commerce, and use.
(a) Applicability. The provisions of this section apply to the
following, as indicated in each paragraph of this section:
(1) Processing incorporation into articles in lubricants and
lubricant additives in machinery manufacturing.
(2) Industrial and commercial conditions of use:
(i) Industrial and commercial use in anti-freeze and de-icing
products, automotive care products, and lubricants and greases;
(ii) Industrial and commercial use in metal products not covered
elsewhere and lubricant and lubricant additives including hydrophilic
coatings;
(iii) Industrial and commercial use in cleaning and degreasing, and
cleaning and furniture care products, including wood cleaners and
gasket removers; and
(iv) Industrial and commercial uses in fertilizer and other
agricultural chemical manufacturing-processing aids and solvents.
(b) Prohibitions. (1) After [DATE 12 MONTHS AFTER THE DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons are
prohibited from manufacturing (including importing) NMP for the uses
listed in paragraphs (a)(1) and (2) of this section.
(2) After [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
processing NMP, including any NMP-containing products, for the
conditions of use listed in paragraphs (a)(1) and (2) of this section.
(3) After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available) NMP, including
any NMP-containing products, to retailers for the conditions
[[Page 51189]]
of use listed in paragraph (a)(2) of this section.
(4) After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons and retailers are
prohibited from distributing in commerce (including making available)
NMP, including any NMP containing products, for the conditions of use
listed in paragraph (a)(2) of this section.
(5) After [DATE 24 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
industrial and commercial use of NMP, including any NMP-containing
products, for the conditions of use listed in paragraphs (a)(2) of this
section.
Sec. 751.207 Concentration limits, container size limits, and labels.
(a) Applicability. The provisions of this section apply to the
following, as indicated in each paragraph of this section.
(1) Processing incorporation into articles in paint additives and
coating additives in transportation equipment manufacturing.
(2) Industrial and commercial conditions of use:
(i) Industrial and commercial use in paints, coatings, and adhesive
removers, except for paint, coating, and adhesive removers for mission-
or safety-critical components of aircraft, spacecraft, and vessels that
are owned or operated by the U.S. Department of Defense and the
National Aeronautics and Space Administration used in accordance with
the requirements listed in Sec. 751.217;
(ii) Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation, except for paints and coatings for
mission- or safety-critical components of aircraft, spacecraft, and
vessels that are owned or operated by the U.S. Department of Defense
and the National Aeronautics and Space Administration used in
accordance with the requirements listed in Sec. 751.217;
(iii) Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale and retail trade;
(iv) Industrial and commercial use in adhesives and sealants
including binding agents, single component glues and adhesives,
including lubricant adhesives and two component glues and adhesives
including some resins, excluding industrial and commercial use in
specific adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants for aviation parts;
(v) Industrial and commercial use in ink, toner, and colorant
products in printer ink; and
(vi) Industrial and commercial use in soldering materials;
(3) Consumer conditions of use:
(i) Consumer use in paint and coating removers;
(ii) Consumer use in adhesive removers;
(iii) Consumer use in paints and coatings in lacquer, stains,
varnishes, primers and floor finishes;
(iv) Consumer use in paint additives and coating additives in
paints and arts and crafts paints;
(v) Consumer use in automotive care products;
(vi) Consumer use in cleaning and furniture care products,
including wood cleaners, gasket removers;
(vii) Consumer use in lubricant and lubricant additives, including
hydrophilic coatings; and
(viii) Consumer use in adhesives and sealants in glues and
adhesives, including lubricant adhesives.
(b) Concentration limits. (1) Beginning [DATE 12 MONTHS AFTER THE
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] all
persons are prohibited from importing NMP formulations and products
containing:
(i) More than 45 percent by weight of NMP for the conditions of use
listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii)
of this section with more than 45 percent by weight of NMP.
(ii) More than 30 percent by weight of NMP for the conditions of
use listed in paragraph (a)(2)(i) of this section.
(iii) More than 5 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(v) of this section.
(iv) More than 1 percent by weight of NMP for the condition of use
listed in paragraph (vi) of this section.
(2) Beginning [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER] all persons are prohibited from
processing NMP into formulations and products containing:
(i) More than 45 percent by weight of NMP for the conditions of use
listed in paragraphs (a)(1), (a)(2)(ii) though (iv) and (a)(3)(viii) of
this section with more than 45 percent by weight of NMP.
(ii) More than 30 percent by weight of NMP for the conditions of
use listed in paragraph (a)(2)(i) of this section.
(iii) More than 5 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(v) of this section.
(iv) More than 1 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(vi) of this section.
(3) After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available) NMP and NMP-
containing products to retailers for:
(i) More than 45 percent by weight of NMP the conditions of use
listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii)
of this section.
(ii) More than 30 percent by weight of NMP for the conditions of
use listed in paragraph (a)(2)(i) of this section.
(iii) More than 5 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(v) of this section.
(iv) More than 1 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(vi) of this section.
(4) After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
distributing in commerce (including making available) NMP and NMP-
containing products containing:
(i) More than 45 percent by weight of NMP for the conditions of use
listed in paragraphs (a)(1), (a)(2)(ii) through (iv), and (a)(3)(viii)
of this section.
(ii) More than 30 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(i) of this section.
(iii) More than 5 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(v) of this section.
(iv) More than 1 percent by weight of NMP and for the condition of
use listed in paragraph (a)(2)(vi) of this section.
(5) After [DATE 24 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all persons are prohibited from
commercial use of NMP and NMP-containing products containing:
(i) More than 45 percent by weight of NMP for the conditions of use
listed in paragraphs (a)(1) and (a)(2)(ii) through (iv) of this
section.
(ii) More than 30 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(i) of this section.
(iii) More than 5 percent by weight of NMP for the condition of use
listed in paragraph (a)(2)(v) of this section.
(iv) More than 1 percent by weight of NMP and for the condition of
use listed in paragraph (a)(2)(vi) of this section.
(c) Container size restrictions and labels. (1) After [DATE 12
MONTHS AFTER THE DATE OF PUBLICATION
[[Page 51190]]
OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons, including
retailers, are prohibited from processing and distributing in commerce
(including making available) NMP or NMP-containing products in
containers with a volume more than 16 ounces for the conditions of use
listed in paragraphs (a)(3)(i) through (vii) of this section.
(2) After [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], all processors and distributors in
commerce of NMP or NMP-containing products for the conditions of use
listed in paragraphs (a)(3)(i) through (vii) of this section must
provide a label securely attached to each product. Label information
must be prominently displayed and in an easily readable font size, with
the sentence ``This product is only for sale in containers of 16 ounces
or less and is for consumer use only'' in bold print or a larger font
for emphasis. Each label must contain the following text:
This product contains n-methylpyrrolidone (NMP) (CASRN 872-50-
4), also called n-methyl-2-pyrrolidone or 1-methyl-2-pyrrolidone, a
chemical determined by the Environmental Protection Agency to
present unreasonable risk of injury to health under the Toxic
Substances Control Act (TSCA), based on developmental and
reproductive effects. The use of NMP is restricted under 40 CFR part
751, subpart C. This product is only for sale in containers of 16
ounces or less and is for consumer use only. This product shall not
be used for commercial purposes.
Sec. 751.209 Workplace Chemical Protection program.
(a) Applicability. The provisions of this section apply to
workplaces engaged in the following conditions of use of NMP, unless
otherwise indicated:
(1) Manufacturing (domestic manufacture).
(2) Manufacturing (import).
(3) All processing, except for the following:
(i) The processing described in Sec. 751.205(a);
(ii) The processing described in Sec. 751.207(a); and
(iii) The processing described in Sec. 751.211(a).
(4) All industrial and commercial use, except for the following:
(i) Those industrial and commercial uses presented in Sec.
751.205(a);
(ii) Those industrial and commercial uses presented in Sec.
751.207(a); and
(iii) Those industrial and commercial uses presented in Sec.
751.211(a).
(5) Disposal.
(b) Direct Dermal Contact Controls (DDCC). The provisions of this
paragraph (b) apply to any workplace engaged in the conditions of use
listed in paragraph (a) of this section.
(1) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER] for Federal agencies and Federal
contractors acting for or on behalf of the Federal Government, [DATE 12
MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER] for other owners and operators, or within 30 days of
introduction of NMP into the workplace, owners or operators must ensure
that all persons are separated, distanced, physically removed, or
isolated from direct dermal contact with NMP in accordance with the
requirements of paragraph (c)(1)(i) of this section and, if necessary,
paragraph (e) of this section.
(2) Owners or operators must comply with all applicable provisions
of paragraphs (c) through (f) of this section.
(c) Exposure control procedures and plan--(1) Methods of
compliance. (i) The owner or operator must institute one or a
combination of elimination, substitution, engineering controls, or
administrative controls to prevent all persons from direct dermal
contact with NMP except to the extent that the owner or operator can
demonstrate that such controls are not feasible.
(ii) Wherever the feasible exposure controls, including one or a
combination of elimination, substitution, engineering controls or
administrative controls, required under paragraph (c)(1)(i) of this
section, which can be instituted are not sufficient to prevent direct
dermal contact, the owner or operator must use them to reduce direct
dermal contact to the extent achievable and must supplement those
controls with the use of dermal PPE that complies with the requirements
of paragraph (e) of this section. Where an owner or operator cannot
demonstrate direct dermal contact is prevented, including through the
use of engineering controls or work practices, and has not demonstrated
that it has supplemented feasible exposure controls with sufficient
dermal PPE that complies with the requirements of paragraph (e) of this
section, this will constitute a failure to comply with the direct
dermal contact control requirements.
(iii) The owner or operator must maintain the effectiveness of
engineering controls and administrative controls instituted under
paragraph (c)(1)(i) of this section.
(iv) The owner or operator must document their exposure control
strategy and implementation in an exposure control plan in accordance
with paragraph (c)(2) of this section.
(2) Exposure control plan requirements. Beginning [DATE 36 MONTHS
AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL
REGISTER] for Federal agencies and Federal contractors acting for or on
behalf of the Federal Government, or [DATE 12 MONTHS AFTER THE DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] for other owners
and operators, owners and operators must include and document in an
exposure control plan the following:
(i) Identification and rationale of exposure controls used or not
used in the following sequence: elimination of NMP, substitution of
NMP, engineering controls and administrative controls to prevent or
reduce direct dermal contact with NMP in the workplace;
(ii) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(iii) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(iv) Actions taken to implement exposure controls selected,
including proper installation, maintenance, training, or other steps
taken;
(v) Description of any restricted areas and how it is demarcated,
and identification of authorized persons; and description of when the
owner or operator expects exposures may be likely to result in direct
dermal contact;
(vi) Regular inspections, evaluations, and updating of the exposure
controls to ensure effectiveness and confirmation that all persons are
implementing them as required;
(vii) Occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes any direct dermal contact with
NMP and subsequent corrective actions taken during start-up, shutdown,
or malfunctions to mitigate exposures to NMP; and
(viii) Availability of the exposure control plan and associated
records for potentially exposed persons.
(d) Restricted areas. (1) Beginning [DATE 36 MONTHS AFTER THE DATE
OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, or [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER] for other owners and operators, the
owner or
[[Page 51191]]
operator who has implemented all feasible engineering, work practice
and administrative controls as required in paragraph (b) of this
section wherever direct dermal contact with NMP may occur must
establish a restricted area.
(2) The owner or operator must limit access to restricted areas to
authorized persons.
(3) The owner or operator must demarcate restricted areas from the
rest of the workplace in a manner that adequately establishes and
alerts persons to the boundaries of the restricted area and minimizes
the number of authorized persons exposed to NMP within the restricted
area.
(4) Whenever any direct dermal contact with NMP may occur within
the restricted area the owner or operator must supply and ensure all
persons are using dermal PPE that complies with the requirements of
paragraph (e) of this section.
(5) The owner or operator must ensure that, within a restricted
area, persons do not engage in non-work activities that may increase
direct dermal contact exposure to NMP.
(e) Personal Protective Equipment (PPE). (1) The provisions of this
paragraph (e) apply to any owner or operator that is required to
provide dermal protection pursuant to paragraph (c) of this section or
respiratory protection pursuant to Sec. 751.211(b)(2).
(2) PPE, including respiratory and dermal protection, that is of
safe design and construction for the work to be performed must be
provided, used, and maintained in a sanitary, reliable, and undamaged
condition. Owners and operators must select PPE that properly fits each
affected person and communicate PPE selections to each affected person.
(3) Owners and operators must provide PPE training in accordance
with 29 CFR 1910.132(f) to all persons required to use PPE prior to or
at the time of initial assignment to a job involving potential exposure
to NMP. For the purposes of this paragraph (e)(3) of this section,
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(4) Owners and operators must retrain each potentially exposed
person required to use PPE annually or whenever the owner or operator
has reason to believe that a previously trained person does not have
the required understanding and skill to properly use PPE, or when
changes in the workplace or in PPE to be used render the previous
training obsolete.
(5) Dermal protection:
(i) The owner or operator must supply and require the donning of
dermal PPE that provides an impermeable barrier to prevent direct
dermal contact with NMP in the specific work area where it is selected
for use, selected in accordance with this paragraph, to each person who
is reasonably likely to be dermally exposed in the work area through
direct dermal contact with NMP.
(ii) Owners or operators must select and provide dermal PPE as
specified in this paragraph (e)(5), and in accordance with 29 CFR
1910.133(b), to each person who is reasonably likely to be dermally
exposed in the work area through direct dermal contact with NMP. For
the purposes of this paragraph (e)(5)(ii), the provisions in 29 CFR
1910.133(b) applying to an ``employer'' also apply equally to owners or
operators.
(iii) Owners or operators must select and provide to persons
appropriate dermal PPE based on an evaluation of the performance
characteristics of the PPE relative to the task(s) to be performed,
conditions present, and the duration of use. Such appropriate dermal
PPE must at minimum include, but is not limited to, the following
items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(iv) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with NMP during normal and expected duration and
conditions of exposure within the work area by evaluating the
specifications from the manufacturer or supplier of the clothing, or of
the material used in construction of the clothing, to establish that
the clothing will be impervious to NMP alone, NMP-containing
formulations, and in likely combination with other chemical substances
in the work area.
(6) Respiratory protection:
(i) The owner or operator must supply a respirator in accordance
with Sec. 751.211(b) and ensure that all persons using NMP-containing
products for those uses specified therein are using the provided
respirators.
(ii) Owners or operators must provide respiratory protection in
accordance with the provisions outlined in 29 CFR 1910.134(a) through
(l) (except paragraphs (d)(1)(iii) and (d)(3)(i)(B)) and as specified
in this paragraph (e). For the purposes of this paragraph (e),
provisions in 29 CFR 1910.134(a) through (l) (except (d)(1)(iii) and
(d)(3)(i)(B)) applying to an ``employee'' also apply equally to
potentially exposed persons, and provisions applying to an ``employer''
also apply equally to owners or operators.
(iii) The respiratory protection requirements in Sec. 751.211(b)
represent the minimum respiratory protection requirements, such that
any respirator affording a higher degree of protection than the
required respirator may be used.
(f) Workplace information and training. (1) The owner or operator
must provide information and training for each person prior to or at
the time of initial assignment to a job involving potential exposure to
NMP.
(2) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(3) The following information and training must be provided to all
persons assigned to a job involving potential exposure to NMP:
(i) The requirements of this paragraph (f), as well as a means to
access or obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
NMP and the specific operations in the workplace that could result in
exposure to NMP, particularly noting where there is potential for
direct dermal contact or inhalation exposure with NMP;
(iii) The principles of safe use and handling of NMP and measures
potentially exposed persons can take to protect themselves from NMP,
including specific procedures the owner or operator has implemented to
protect potentially exposed persons from exposure to NMP, such as
appropriate work practices, emergency procedures, and PPE to be used;
(iv) Methods and observations that may be used to detect the
presence or release of NMP in the workplace; and
(v) The health hazards of NMP in the workplace.
(4) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of NMP in the
workplace.
(5) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase potential for direct dermal contact or inhalation exposures,
the owner or operator must update the training as necessary to ensure
that each potentially
[[Page 51192]]
exposed person has the requisite proficiency.
Sec. 751.211 Prescriptive workplace requirements.
(a) Applicability. The provisions of this section apply to the
workplaces engaged in the following conditions of use of NMP, unless
otherwise indicated: (1) Processing incorporation into articles in
paint additives and coating additives in transportation equipment
manufacturing.
(2) Industrial and commercial conditions of use:
(i) Industrial and commercial use in paints, coatings, and adhesive
removers, except for those used listed in Sec. 751.217(a);
(ii) Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers and floor finishes, and powder
coatings in surface preparation, except for those used listed in Sec.
751.217(a);
(iii) Industrial and commercial use in paint additives and coating
additives in construction, fabricated metal product manufacturing,
machinery manufacturing, other manufacturing, paint and coating
manufacturing, primary metal manufacturing, transportation equipment
manufacturing, wholesale, and retail trade;
(iv) Industrial and commercial use in adhesives and sealants
including binding agents, single component glues and adhesives,
including lubricant adhesives and two component glues and adhesives
including some resins, excluding industrial and commercial use in
specific adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants for aviation parts;
(v) Industrial and commercial use in ink, toner, and colorant
products in printer ink; and
(vi) Industrial and commercial use in soldering materials.
(b) Prescriptive controls--Applicability. (1) The provisions of
this paragraph (b) apply to any workplace engaged in the conditions of
use listed in paragraph (a) of this section. (2) Personal Protective
Equipment (PPE). (i) The provisions of this paragraph (b) apply after
[DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
FEDERAL REGISTER] (ii) For the conditions of use listed in paragraphs
(a)(1) and (a)(2)(ii) through (iv) of this section, owners or operators
must ensure that all persons using NMP-containing products are provided
with dermal protective equipment as required in Sec. 751.209(e)(2) and
(5), any NIOSH Approved[supreg] air-purifying respirator equipped with
organic vapor cartridges or canisters (minimum APF 10) as required in
Sec. 751.209(e)(6), and training on proper use of PPE as required in
Sec. 751.209(e)(3) and (4).
(A) For the condition of use listed in paragraph (a)(2)(i) of this
section, owners or operators must ensure that all persons using NMP-
containing products are provided with dermal protective equipment as
required in Sec. 751.209(e)(2) and (5), any NIOSH Approved[supreg]
air-purifying respirator equipped with organic vapor cartridges or
canisters; any NIOSH Approved[supreg] powered air-purifying respirator
equipped with organic vapor cartridges; or any NIOSH Approved[supreg]
continuous flow supplied air respirator equipped with a hood or helmet
(minimum APF 25) as required in Sec. 751.209(e)(6), and training on
proper use of PPE as required in Sec. 751.209(e)(3) and (4).
(B) For the conditions of use listed in paragraphs (a)(2)(v) and
(vi) of this section, owners or operators must ensure that all persons
using NMP-containing products are provided with dermal protective
equipment as required in Sec. 751.209(e)(2) and (5) and training on
proper use of PPE as required in Sec. 751.209(e)(3) and (4).
Sec. 751.213 Recordkeeping requirements.
(a) General records. After [DATE 60 DAYS AFTER THE DATE OF
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], all persons who
manufacture, process, distribute in commerce, or engage in industrial
or commercial use of NMP or NMP-containing products must maintain
ordinary business records, such as invoices and bills-of-lading related
to compliance with the prohibitions, restrictions, and other provisions
of this subpart.
(b) Workplace Chemical Protection Program (WCPP) compliance--(1)
DDCC compliance. Owners or operators subject to DDCC requirements
described in Sec. 751.209(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.209(c);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.209(e), including:
(A) The name, workplace address, work shift, job classification,
and work area of each person reasonably likely to directly handle NMP
or handle equipment or materials on which NMP may present and the type
of PPE selected to be worn by each of these persons;
(B) The basis for specific PPE selection (e.g., demonstration based
on permeation testing or manufacturer specifications that each item of
PPE selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE;
(D) Occurrence and duration of any direct dermal contact with NMP
that occurs during any activity or malfunction at the workplace that
causes direct dermal exposures to occur and/or glove breakthrough, and
corrective actions to be taken during and immediately following that
activity or malfunction to prevent direct dermal contact to NMP; and
(E) Training in accordance with Sec. 751.209(e)(3).
(iii) Information and training provided by the regulated entity to
each person prior to or at the time of initial assignment to a job
involving potential direct dermal contact with NMP and any re-training
as required in Sec. 751.209(f).
(2) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person to NMP direct
dermal contact exposure to readily access the exposure control plans,
facility exposure monitoring records, PPE program implementation, or
any other information relevant to NMP exposure in the workplace. (c)
Prescriptive requirements. Owners and operators subject to the
requirements described in Sec. 751.207 and Sec. 751.211 must retain
records of: (1) Documentation identifying implementation of and
compliance with the concentration limits listed in Sec. 751.207(b);
(2) Dermal protection used by each potentially exposed person as
described in Sec. 751.211(b) and PPE program implementation, as
described in Sec. 751.209(e); and
(3) Respiratory protection used by each potentially exposed person
as described in Sec. 751.211(b) and (vi) and PPE program
implementation, as described in Sec. 751.209(e).
(d) Additional recordkeeping for mission- or safety-critical uses
of paint, coating, or adhesive removers or paints and coatings. (1)
Owners and operators subject to the requirements described in Sec.
751.217 must retain the following: (i) Each self-certification
statement for each facility that is self-certifying, including:
(A) The written statement required by Sec. 751.217(b)(2)(i);
[[Page 51193]]
(B) Printed name and signature, job classification, email address
and phone number of the owner or operator who is self-certifying;
(C) Date of self-certification; and
(D) Name and address of the facility.
(ii) All records required by paragraphs (a) and (b) of this
section.
(2) Sellers and distributors of NMP subject to the requirements
described in Sec. 751.217 must also retain the following:
(i) Invoices that include:
(A) Name of facility;
(B) Name of owner or operator who is self-certifying;
(C) Date of sale; and
(D) Quantity of NMP being purchased, and concentration by weight of
NMP if applicable in NMP-containing products.
(ii) Self-certification statement for each purchase of NMP.
(iii) Copies of the downstream notifications required by Sec.
751.217(b)(5).
(iv) Copies of the labels required by Sec. 751.217(b)(6).
(e) Retention. Persons required to maintain records required under
this section for a period of 5 years from the date that such records
were generated. 751.215Downstream notification.
(a) Beginning on [DATE 2 MONTHS AFTER THE DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER], each person who manufactures
(including imports) NMP for any condition of use specified in
Sec. Sec. 751.209 and 751.211, except for those specified in Sec.
751.217 must, prior to or concurrent with the shipment, notify
companies to whom NMP is shipped, in writing, of the restrictions
described in this subpart in accordance with paragraph (c) of this
section.
(b) Beginning on [DATE 6 MONTHS AFTER THE DATE OF PUBLICATION OF
THE FINAL RULE IN THE FEDERAL REGISTER], each person who processes or
distributes in commerce NMP or any NMP-containing products for any
condition of use specified in Sec. 751.209 and Sec. 751.211, except
for those specified in Sec. 751.217 must, prior to or concurrent with
the shipment, notify companies to whom NMP is shipped, in writing, of
the restrictions described in this subpart in accordance with paragraph
(c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in section 1(c) and
15 of the Safety Data Sheet (SDS) provided with the NMP or with any
NMP-containing product:
After [DATE 21 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], this chemical/product cannot be
distributed in commerce or processed with a concentration of NMP
greater than 0.1% by weight for the following purposes: Processing
incorporation into articles in lubricants and lubricant additives in
machinery manufacturing; Industrial and commercial use in anti-
freeze and de-icing products, automotive care products, and
lubricants and greases; Industrial and commercial use in metal
products not covered elsewhere and lubricant and lubricant additives
including hydrophilic coatings; Industrial and commercial use in
cleaning and degreasing, and cleaning and furniture care products,
including wood cleaners and gasket removers; and Industrial and
commercial uses in fertilizer and other agricultural chemical
manufacturing-processing aids and solvents.
Sec. 751.217 Mission- or safety-critical uses of paint, coating, or
adhesive removers or paints and coatings.
(a) General. To be eligible to use NMP in paint, coating, and
adhesive removers and paints and coatings at concentrations higher than
those prohibited under 751.207(b), regulated parties must comply with
all conditions in this section. The following uses are covered by this
section: (1) Import, processing, distribution in commerce, and use of
paints and coatings with more than 45 percent by weight of NMP, for
mission- or safety-critical components of aircraft, spacecraft, and
vessels that are owned or operated by the U.S. Department of Defense
and the National Aeronautics and Space Administration. (2) Import,
processing, distribution in commerce, and use of paint, coating, and
adhesive removers with more than 30 percent by weight of NMP for
mission- or safety-critical components of aircraft, spacecraft, and
vessels that are owned or operated by the U.S. Department of Defense
and the National Aeronautics and Space Administration.
(b) Conditions--(1) Personnel and location. The commercial uses
listed in paragraph (a) of this section must be performed by agency
employees or agency contractor employees at locations controlled by the
agency or the agency's contractor.
(2) Self-certification. The owner or operator purchasing and using
NMP for the conditions of use listed in paragraph (a) of this section
must self-certify each location controlled by the agency or the
agency's contractor for those uses.
(i) The self-certification must include the following written
statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. The
facility in which this product will be used is a Federal
installation, a Federal industrial facility, or a Federal contractor
facility performing paint or coating work, or paint, coating, or
adhesive removal work for DOD and NASA projects. This facility's
implementation of the Workplace Chemical Protection Program (WCPP)
for NMP was evaluated by qualified personnel and that this facility
has implemented and complies with the WCPP for NMP. Based on my
inquiry of the person or persons who manage the facility and/or
those persons directly responsible for implementing the NMP WCPP,
and to the best of my knowledge and belief, the facility is
implementing the NMP WCPP, including the exposure control plan and
other proper documentation of the actions taken is available at the
facility upon request. I am aware that there are significant
penalties, including the possibility of civil penalties for failing
to comply with these requirements and criminal penalties, including
fines and imprisonment, for knowingly failing to comply with these
requirements. I understand that this certification shall serve as a
certification that this facility will properly implement and comply
with the WCPP for NMP consistent with the applicable regulatory
timelines.
(ii) The self-certification must also include the following:
(A) Printed name and signature, job classification, title, email
address, and phone number of the owner or operator who is self-
certifying;
(B) Date of self-certification;
(C) Name and address of the facility; and
(D) An indication of whether this is the facility's first purchase
of NMP, after [DATE OF PUBLICATION OF THE FINAL RULE].
(iii) Owners or operators must provide a copy of the self-
certification statement for each facility to the distributor from whom
NMP is being purchased, for every purchase.
(iv) Distributors of NMP must review the self-certification
statement to ensure it is appropriately completed to include the owner
or operator's and the facility's information required by this section.
(3) Workplace chemical protection program. The owner or operator of
the locations processing or engaging in the commercial uses listed in
paragraph (a) of this section must comply with the Workplace Chemical
Protection Program provisions in described in Sec. 751.209.
(4) Recordkeeping. The owner or operator of the locations
processing or engaging in the commercial uses listed in paragraph (b)
of this section must comply with the recordkeeping requirements in
Sec. 751.213.
(5) Downstream notification. All importers, processors and
distributors in commerce of NMP for the uses listed in paragraph (a) of
this section must provide downstream notification of the restrictions
on use of these products by adding the following language to sections
1(c) and 15 of the SDS:
[[Page 51194]]
After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER], this chemical/product is and can only
be distributed in commerce or processed for the following purposes:
paints and coatings or paint, coating, or adhesive removal by the
Department of Defense (DOD), the National Aeronautics and Space
Administration (NASA), or their contractors, at Federal
installations, Federal industrial facilities, or at Federal
contractor facilities performing work only for DOD and NASA
projects.
(6) Labeling. All processors and distributors in commerce of NMP or
NMP-containing products for the conditions of use listed in paragraph
(a) of this section must provide a label securely attached to each
product. Label information must be prominently displayed and in an
easily readable font size. Each label must contain the following text:
This product contains n-methylpyrrolidone (NMP), a chemical
determined by the Environmental Protection Agency to present
unreasonable risk of injury to health under Section 6 of the Toxic
Substances Control Act, based on developmental and reproductive
effects. This product containing NMP is restricted under 40 CFR part
751, subpart C. This product is only for sale and can only be used
by the Department of Defense (DOD), the National Aeronautics and
Space Administration (NASA), or their contractors, at Federal
installations, Federal industrial facilities, or at Federal
contractor facilities performing work only for DOD and NASA
projects.
[FR Doc. 2024-12643 Filed 6-13-24; 8:45 am]
BILLING CODE 6560-50-P