[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77596-77602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27438]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0743; FRL-9943-02-OCSPP]


n-Methylpyrrolidone (NMP); Revision to Toxic Substances Control 
Act (TSCA) Risk Determination; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final revision to the risk determination for the n-
methylpyrrolidone (NMP) risk evaluation issued under the Toxic 
Substances Control Act (TSCA). The revision to the NMP risk 
determination reflects the announced policy changes to ensure the 
public is protected from unreasonable risks from chemicals in a way 
that is supported by science and the law. EPA determined that NMP, as a 
whole chemical substance, presents an unreasonable risk of injury to 
health when evaluated under its conditions of use. In addition, this 
revised risk determination does not reflect an assumption that workers 
always appropriately wear personal protective equipment (PPE). EPA 
understands that there could be adequate occupational safety 
protections in place at certain workplace locations; however, not 
assuming use of PPE reflects EPA's recognition that unreasonable risk 
may exist for subpopulations of workers that may be highly exposed 
because they are not covered by Occupational Safety and Health 
Administration (OSHA) standards, or their employers are out of 
compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are 
described by OSHA as being ``outdated and inadequate for ensuring 
protection of worker health,'' or because OSHA has not issued a 
chemical-specific permissible exposure limit (PEL) (as is the case for 
NMP), or because EPA finds unreasonable risk for purposes of TSCA 
notwithstanding OSHA requirements. This revision supersedes the 
condition of use-specific no unreasonable risk determinations in the 
December 2020 NMP Risk Evaluation and withdraws the associated TSCA 
order included in the December 2020 NMP Risk Evaluation.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0743, is available online 
at https://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Additional instructions on 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, Office of Pollution 
Prevention and Toxics (7404M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202)

[[Page 77597]]

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. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to those involved in the manufacture, processing, 
distribution, use, disposal, and/or the assessment of risks involving 
chemical substances and mixtures. You may be potentially affected by 
this action if you manufacture (defined under TSCA to include import), 
process (including recycling), distribute in commerce, use or dispose 
of NMP, including NMP in products. Since other entities may also be 
interested in this revision to the risk determination, EPA has not 
attempted to describe all the specific entities that may be affected by 
this action.

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

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to determine whether 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 potentially exposed or susceptible subpopulation 
(PESS) identified as relevant to the risk evaluation by the 
Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A). 
TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and 
minimum requirements applicable to this process, including provisions 
that provide instruction on chemical substances that must undergo 
evaluation, the minimum components of a TSCA risk evaluation, and the 
timelines for public comment and completion of the risk evaluation. 
TSCA also requires that EPA operate in a manner that is consistent with 
the best available science, make decisions based on the weight of the 
scientific evidence, and consider reasonably available information. 15 
U.S.C. 2625(h), (i), and (k).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    EPA has inherent authority to reconsider previous decisions and to 
revise, replace, or repeal a decision to the extent permitted by law 
and supported by reasoned explanation. FCC v. Fox Television Stations, 
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. 
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to 
such authority, EPA has reconsidered and is now finalizing a revised 
risk determination for NMP.

C. What action is EPA taking?

    EPA is announcing the availability of the final revision to the 
risk determination for the NMP risk evaluation issued under TSCA that 
published in December 2020 (Ref. 1). In July 2022, EPA sought public 
comment on the draft revisions (87 FR 39511, July 1, 2022). EPA 
appreciates the public comments received on the draft revision to the 
NMP risk determination. After review of these comments and 
consideration of the specific circumstances of NMP, EPA concludes that 
the Agency's risk determination for NMP is better characterized as a 
whole chemical risk determination rather than condition-of-use-specific 
risk determinations. Accordingly, EPA is revising and replacing section 
5 of the December 2020 NMP Risk Evaluation (Ref. 2) where the findings 
of unreasonable risk to health were previously made for the individual 
conditions of use evaluated. EPA is also withdrawing the previously 
issued TSCA section 6(i)(l) order for 11 conditions of use previously 
determined not to present unreasonable risk which was included in 
section 5.4.1 of the December 2020 NMP Risk Evaluation (Ref. 2).
    This final revision to the NMP risk determination is consistent 
with EPA's plans to revise specific aspects of the first ten TSCA 
chemical risk evaluations to ensure that the risk evaluations better 
align with TSCA's objective of protecting health and the environment. 
As a result of this revision, removing the assumption that workers 
always and appropriately wear PPE (see unit II.C.) means that: three 
additional conditions of use in addition to the original 26 drive the 
unreasonable risk for NMP, and for five conditions of use, acute 
effects in addition to chronic effects also drive the unreasonable risk 
to workers. However, EPA is not making condition-of-use-specific risk 
determinations for those conditions of use, and for purposes of TSCA 
section 6(i), EPA is not issuing a final order under TSCA section 
6(i)(1) for the conditions of use that do not drive the unreasonable 
risk, and does not consider the revised risk determination to 
constitute a final agency action at this point in time. Overall, 29 
conditions of use out of 37 EPA evaluated drive the NMP whole chemical 
unreasonable risk determination due to risks identified for human 
health. The full list of the conditions of use evaluated for the NMP 
TSCA risk evaluation is in Table 1-6 of the December 2020 NMP Risk 
Evaluation (Ref. 2).

II. Background

A. Why is EPA re-issuing the risk determination for the NMP risk 
evaluation conducted under TSCA?

    In accordance with Executive Order 13990 (``Protecting Public 
Health and the Environment and Restoring Science to Tackle the Climate 
Crisis'') and other Administration priorities (Refs. 3, 4, 5, and 6), 
EPA reviewed the risk evaluations for the first ten chemical 
substances, including NMP, to ensure that they meet the requirements of 
TSCA, including conducting decision-making in a manner that is 
consistent with the best available science.
    As a result of this review, EPA announced plans to revise specific 
aspects of the first ten risk evaluations in order to ensure that the 
risk evaluations appropriately identify unreasonable risks and thereby 
help ensure the protection of human health and the environment (Ref. 
7). Following a review of specific aspects of the December 2020 NMP 
Risk Evaluation (Ref. 2) and after considering comments received on a 
draft revised risk determination for NMP, EPA has determined that 
making an

[[Page 77598]]

unreasonable risk determination for NMP as a whole chemical substance, 
rather than making unreasonable risk determinations separately on each 
individual condition of use evaluated in the risk evaluation, is the 
most appropriate approach for NMP under the statute and implementing 
regulations. In addition, EPA's final risk determination is explicit 
insofar as it does not rely on assumptions regarding the use of PPE in 
making the unreasonable risk determination under TSCA section 6, even 
though some facilities might be using PPE as one means to reduce worker 
exposures; rather, the use of PPE as a means of addressing unreasonable 
risk will be considered during risk management, as appropriate.
    Separately, EPA is conducting a screening approach to assess risks 
from the air and water pathways for several of the first 10 chemicals, 
including this chemical. For NMP the exposure pathways that were or 
could be regulated under another EPA administered statute were not 
fully assessed as part of the final risk evaluation (see section 1.4.2 
of the December 2020 NMP Risk Evaluation). 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. In 
the December 2020 NMP 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. This resulted in the ambient air and drinking water pathways 
for NMP not being fully assessed in the risk evaluation published in 
December 2020. The goal of the recently-developed screening approach is 
to provide a more robust assessment of these pathways for NMP and to 
determine if there may be risks that were unaccounted for in the NMP 
risk evaluation. The screening-level approach has gone through public 
comment and independent external peer review through the Science 
Advisory Committee on Chemicals (SACC). The Agency received the final 
peer review report on May 18, 2022, and has reviewed public comments 
and SACC comments. EPA expects to describe its findings regarding the 
chemical-specific application of this screening-level approach in the 
forthcoming proposed rule under TSCA section 6(a) for NMP.
    This action pertains only to the risk determination for NMP. While 
EPA intends to consider and may take additional similar actions on 
other of the first ten chemicals, EPA is taking a chemical-specific 
approach to reviewing these risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of 
Congressional direction on the need to complete risk evaluations and 
move toward any associated risk management activities in accordance 
with statutory deadlines.

B. What is a whole chemical view of the unreasonable risk determination 
for the NMP risk evaluation?

    TSCA section 6 repeatedly refers to determining whether a chemical 
substance presents unreasonable risk under its conditions of use. 
Stakeholders have disagreed over whether a chemical substance should 
receive: A single determination that is comprehensive for the chemical 
substance after considering the conditions of use, referred to as a 
whole-chemical determination; or multiple determinations, each of which 
is specific to a condition of use, referred to as condition-of-use-
specific determinations.
    As explained in the Federal Register document announcing the 
availability of the draft revised risk determination for NMP (87 FR 
39511, July 1, 2022 (FRL-9943-01-OCSPP)), the proposed Risk Evaluation 
Procedural Rule (Ref. 8) was premised on the whole chemical approach to 
making unreasonable risk determinations. In that proposed rule, EPA 
acknowledged a lack of specificity in statutory text that might lead to 
different views about whether the statute compelled EPA's risk 
evaluations to address all conditions of use of a chemical substance or 
whether EPA had discretion to evaluate some subset of conditions of use 
(i.e., to scope out some manufacturing, processing, distribution in 
commerce, use, or disposal activities), but also stated that ``EPA 
believes the word `the' [in TSCA section 6(b)(4)(A)] is best 
interpreted as calling for evaluation that considers all conditions of 
use.'' The proposed rule, however, was unambiguous on the point that 
unreasonable risk determinations would be for the chemical substance as 
a whole, even if based on a subset of uses. See Ref. 8 at pages 7565-66 
(``TSCA section 6(b)(4)(A) specifies that a risk evaluation must 
determine whether `a chemical substance' presents an unreasonable risk 
of injury to health or the environment `under the conditions of use.' 
The evaluation is on the chemical substance--not individual conditions 
of use--and it must be based on `the conditions of use.' In this 
context, EPA believes the word `the' is best interpreted as calling for 
evaluation that considers all conditions of use.''). In the proposed 
regulatory text, EPA proposed to determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use. (Ref. 8 at 7480.)
    The final Risk Evaluation Procedural Rule stated (82 FR 33726, July 
20, 2017 (FRL-9964-38)) (Ref. 9): ``As part of the risk evaluation, EPA 
will determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under each condition of 
uses [sic] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents'' (40 CFR 702.47). 
For the unreasonable risk determinations in the first ten risk 
evaluations, EPA applied this provision by making individual risk 
determinations for each condition of use evaluated as part of each risk 
evaluation document (i.e., the condition-of-use-specific approach to 
risk determinations). That approach was based on one particular passage 
in the preamble to the final Risk Evaluation Rule which stated that EPA 
will make individual risk determinations for all conditions of use 
identified in the scope. (Ref. 9 at 33744).
    In contrast to this portion of the preamble of the final Risk 
Evaluation Rule, the regulatory text itself and other statements in the 
preamble reference a risk determination for the chemical substance 
under its conditions of use, rather than separate risk determinations 
for each of the conditions of use of a chemical substance. In the key 
regulatory provision excerpted previously from 40 CFR 702.47, the text 
explains that ``[a]s part of the risk evaluation, EPA will determine 
whether the chemical substance presents an unreasonable risk of injury 
to health or the environment under each condition of uses [sic] within 
the scope of the risk evaluation, either in a single decision document 
or in multiple decision documents'' (Ref. 9, emphasis added). Other 
language reiterates this perspective. For example, 40 CFR 702.31(a) 
states that the purpose of the rule is to establish the EPA process for 
conducting a risk evaluation to determine whether a chemical substance 
presents an unreasonable risk of injury to health or the environment as 
required under TSCA section 6(b)(4)(B). Likewise, there are recurring 
references to whether the chemical substance presents an unreasonable 
risk in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which 
explains

[[Page 77599]]

that the extent to which EPA will refine its evaluations for one or 
more condition of use in any risk evaluation will vary as necessary to 
determine whether a chemical substance presents an unreasonable risk. 
Notwithstanding the one preambular statement about condition-of-use-
specific risk determinations, the preamble to the final rule also 
contains support for a risk determination on the chemical substance as 
a whole. In discussing the identification of the conditions of use of a 
chemical substance, the preamble notes that this task inevitably 
involves the exercise of discretion on EPA's part, and ``as EPA 
interprets the statute, the Agency is to exercise that discretion 
consistent with the objective of conducting a technically sound, 
manageable evaluation to determine whether a chemical substance--not 
just individual uses or activities--presents an unreasonable risk'' 
(Ref. 9 at 33729).
    Therefore, notwithstanding EPA's choice to issue condition-of-use-
specific risk determinations to date, EPA interprets its risk 
evaluation regulation to also allow the Agency to issue whole-chemical 
risk determinations. Either approach is permissible under the 
regulation. A panel of the Ninth Circuit Court of Appeals also 
recognized the ambiguity of the regulation on this point. Safer 
Chemicals v. EPA, 943 F.3d. 397, 413 (9th Cir. 2019) (holding a 
challenge about ``use-by-use risk evaluations [was] not justiciable 
because it is not clear, due to the ambiguous text of the Risk 
Evaluation Rule, whether the Agency will actually conduct risk 
evaluations in the manner Petitioners fear'').
    EPA plans to consider the appropriate approach for each chemical 
substance risk evaluation on a case-by-case basis, taking into account 
considerations relevant to the specific chemical substance in light of 
the Agency's obligations under TSCA. The Agency expects that this case-
by-case approach will provide greater flexibility in the Agency's 
ability to evaluate and manage unreasonable risk from individual 
chemical substances. EPA believes this is a reasonable approach under 
TSCA and the Agency's implementing regulations.
    With regard to the specific circumstances of NMP, EPA has 
determined that a whole chemical approach is appropriate for NMP in 
order to protect health and the environment. The whole chemical 
approach is appropriate for NMP because there are benchmark exceedances 
for a substantial number of conditions of use (spanning across most 
aspects of the chemical lifecycle--from manufacturing (including 
import), processing, industrial and commercial use, consumer use, and 
disposal) for workers and consumers and risk of irreversible health 
effects (specifically developmental post implantation fetal loss and 
reduced fertility and fecundity) associated with NMP exposures. Because 
these chemical-specific properties cut across the conditions of use 
within the scope of the risk evaluation, a substantial amount of the 
conditions of use drive the unreasonable risk; therefore, it is 
appropriate for the Agency to make a determination for NMP that the 
whole chemical presents an unreasonable risk.
    As explained later in this document, the revisions to the 
unreasonable risk determination (section 5 of the December 2020 NMP 
Risk Evaluation (Ref. 2)) follow the issuance of a draft revision to 
the TSCA NMP unreasonable risk determination (87 FR 39511, July 1, 
2022) and the receipt of public comment. A response to comments 
document is also being issued with the final revised unreasonable risk 
determination for NMP (Ref. 10). The revisions to the unreasonable risk 
determination are based on the existing risk characterization section 
of the December 2020 NMP Risk Evaluation (Ref. 2) (section 4) and do 
not involve additional technical or scientific analysis. The discussion 
of the issues in this Federal Register document and in the accompanying 
final revised risk determination for NMP supersede any conflicting 
statements in the December 2020 NMP Risk Evaluation (Ref. 2) and the 
earlier response to comments document (Ref. 11). EPA views the peer 
reviewed hazard and exposure assessments and associated risk 
characterization as robust and upholding the standards of best 
available science and weight of the scientific evidence per TSCA 
sections 26(h) and (i).
    For purposes of TSCA section 6(i), EPA is making a risk 
determination on NMP as a whole chemical. Under the revised approach, 
the ``whole chemical'' risk determination for NMP supersedes the no 
unreasonable risk determinations for NMP that were premised on a 
condition-of-use-specific approach to determining unreasonable risk and 
also contains an order withdrawing the TSCA section 6(i)(1) order in 
section 5.4.1 of the December 2020 NMP Risk Evaluation (Ref. 2).

C. What revision is EPA now making final about the use of PPE for the 
NMP risk evaluation?

    In the risk evaluations for the first ten chemical substances, as 
part of the unreasonable risk determination, EPA assumed for several 
conditions of use that workers were provided and always used PPE in a 
manner that achieves the stated assigned protection factor (APF) for 
respiratory protection, or used chemically-resistant gloves for dermal 
protection. In support of this assumption, EPA used reasonably 
available information such as public comments indicating that some 
employers, particularly in the industrial setting, provide PPE to their 
employees and follow established worker protection standards (e.g., 
OSHA requirements for protection of workers).
    For the December 2020 NMP Risk Evaluation (Ref. 2), EPA assumed, 
based on reasonably available information, including public comment and 
safety data sheets for NMP, that workers use PPE--specifically, 
respirators with an APF 10 and gloves with a protection factor (PF) 
ranging from 5 to 10--for all occupational conditions of use. In the 
December 2020 NMP Risk Evaluation, EPA determined that there is 
unreasonable risk to these workers for 25 of the 28 occupational COUs 
even with this assumed PPE use.
    EPA is revising the assumption for NMP that workers always and 
properly use PPE. However, this does not mean that EPA questions the 
veracity of public comments which describe occupational safety 
practices often followed by industry. EPA believes it is appropriate 
when conducting risk evaluations under TSCA to evaluate the levels of 
risk present in baseline scenarios where PPE is not assumed to be used 
by workers. This approach of not assuming PPE use by workers considers 
the risk to potentially exposed or susceptible subpopulations of 
workers who may not be covered by OSHA standards, such as self-employed 
individuals and public sector workers who are not covered by a State 
Plan. It should be noted that, in some cases, baseline conditions may 
reflect certain mitigation measures, such as engineering controls, in 
instances where exposure estimates are based on monitoring data at 
facilities that have engineering controls in place.
    In addition, EPA believes it is appropriate to evaluate the levels 
of risk present in scenarios considering applicable OSHA requirements 
(e.g., chemical-specific permissible exposure limits (PELs) and/or 
chemical-specific PELs with additional substance-specific standards), 
as well as scenarios considering industry or sector best practices for 
industrial hygiene that are clearly articulated to the Agency. 
Consistent with this approach, the December 2020 NMP Risk Evaluation

[[Page 77600]]

(Ref. 2) characterized risk to workers both with and without the use of 
PPE. By characterizing risks using scenarios that reflect different 
levels of mitigation, EPA risk evaluations 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, or to ensure that applicable 
OSHA requirements or industry or sector best practices that address the 
unreasonable risk are required for all potentially exposed and 
susceptible subpopulations (including self-employed individuals and 
public sector workers who are not covered by an OSHA State Plan).
    When undertaking unreasonable risk determinations as part of TSCA 
risk evaluations, however, EPA does not believe it is appropriate to 
assume as a general matter that an applicable OSHA requirement or 
industry practice related to PPE use is consistently and always 
properly applied. Mitigation scenarios included in the EPA risk 
evaluation (e.g., scenarios considering use of various PPE) likely 
represent what is happening already in some facilities. However, the 
Agency cannot assume that all facilities have adopted these practices 
for the purposes of making the TSCA risk determination (Ref. 12).
    Therefore, EPA is making a determination of unreasonable risk for 
NMP from a baseline scenario that does 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 the baseline scenario 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 non-
compliance 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 public sector workers 
who are not covered by a State Plan, or because their employer is out 
of compliance with OSHA standards, or because many of OSHA's chemical-
specific permissible exposure limits largely adopted in the 1970's are 
described by OSHA as being ``outdated and inadequate for ensuring 
protection of worker health,'' (Ref. 13), or because OSHA has not 
issued a permissible exposure limit (PEL) (as is the case for NMP), or 
because EPA finds unreasonable risk for purposes of TSCA 
notwithstanding OSHA requirements.
    In accordance with this approach, EPA is finalizing the revision to 
the NMP risk determination without relying on assumptions regarding the 
occupational use of PPE in making the unreasonable risk determination 
under TSCA section 6; rather, information on the use of PPE as a means 
of mitigating risk (including public comments received from industry 
respondents about occupational safety practices in use) will be 
considered during the risk management phase, as appropriate. This 
represents a change from the approach taken in the December 2020 NMP 
Risk Evaluation (Ref. 2). As a general matter, when undertaking risk 
management actions, EPA intends to strive for consistency with 
applicable OSHA requirements and industry best practices, including 
appropriate application of the hierarchy of controls, to the extent 
that applying those measures would address the identified unreasonable 
risk, including unreasonable risk to potentially exposed or susceptible 
subpopulations. Consistent with TSCA section 9(d), EPA will consult and 
coordinate 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, comprehensive 
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 or be sufficient to address the unreasonable risk.
    Removing the assumption that workers always and appropriately wear 
PPE in making the whole chemical risk determination for NMP means that: 
three conditions of use in addition to the original 26 drive the 
unreasonable risk for NMP (industrial and commercial use in ink, toner, 
and colorant products; industrial and commercial use in other uses 
soldering materials; and industrial and commercial use in other uses in 
fertilizer and other agricultural chemical manufacturing--processing 
aids and solvents). Additionally, for five conditions of use, acute 
effects in addition to chronic effects also drive the unreasonable risk 
to workers (the five conditions of use are: processing for 
incorporation into articles in paint additives and coating additives 
not described by other codes in transportation equipment manufacturing; 
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, powder 
coatings (surface preparation); industrial and commercial use paint 
additives and coating additives in multiple manufacturing sectors; and 
industrial and commercial use in adhesives and sealants including 
binding agents, single component glues and adhesives, including 
lubricant additives, two-component glues, and adhesives including some 
resins). The finalized revision to the NMP risk determination clarifies 
that EPA does not rely on the assumed use of PPE when making the risk 
determination for the whole substance; rather, the use of PPE as a 
means of addressing unreasonable risk will be considered during risk 
management, as appropriate.

D. What is NMP?

    NMP is a water-miscible, organic solvent that is often used as a 
substitute for halogenated solvents. NMP exhibits a unique set of 
physical and chemical properties that have proven useful in a range of 
industrial, commercial, and consumer applications. NMP has a wide range 
of uses, including in the production of paints and coatings, as a 
solvent for cleaning and degreasing, and in the manufacture of 
electronics. There are also a variety of consumer and commercial 
products that contain NMP, such as adhesives and sealants, as well as 
adhesive removers, automotive care products, and paints and coatings. 
NMP is both manufactured domestically and imported into the United 
States.

E. What conclusions is EPA finalizing today in the revised TSCA risk 
evaluation based on the whole chemical approach and not assuming the 
use of PPE?

    EPA determined that NMP presents an unreasonable risk to health 
under the conditions of use. EPA's unreasonable risk determination for 
NMP as a chemical substance is driven by risks associated with the 
following conditions of use, considered singularly or in combination 
with other exposures:
     Manufacturing--Domestic manufacture;
     Manufacturing--Import;
     Processing as a reactant or intermediate in plastic 
material and resin manufacturing and other non-incorporative 
processing;

[[Page 77601]]

     Processing for incorporation into a formulation, mixture, 
or reaction product in multiple sectors;
     Processing for incorporation into articles--in lubricants 
and lubricant additives in machinery manufacturing;
     Processing for incorporation into articles in paint 
additives and coating additives not described by other codes in 
transportation equipment manufacturing;
     Processing for incorporation into articles as a solvent 
(which become part of product formulation or mixture), including in 
textiles, apparel, and leather manufacturing;
     Processing for incorporation into articles in other 
sectors, including in plastic product manufacturing;
     Processing in recycling;
     Processing for repackaging (wholesale and retail trade);
     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, powder 
coatings (surface preparation);
     Industrial and commercial use in paint additives and 
coating additives not described by other codes in computer and 
electronic product manufacturing in electronic parts manufacturing;
     Industrial and commercial use paint additives and coating 
additives not described by other codes in computer and electronic 
product manufacturing in semiconductor manufacturing;
     Industrial and commercial use paint additives and coating 
additives in multiple manufacturing sectors;
     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 in semiconductor manufacturing;
     Industrial and commercial use in processing aids specific 
to petroleum production in petrochemical manufacturing, in other uses 
in oil and gas drilling, extraction, and support activities, and in 
functional fluids (closed systems);
     Industrial and commercial use in adhesives and sealants 
including binding agents, single component glues and adhesives, 
including lubricant additives, two-component glues, and adhesives 
including some resins;
     Industrial and commercial use in other uses 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 uses in other uses in laboratory 
chemicals;
     Industrial and commercial uses in other uses in lithium 
ion battery manufacturing;
     Industrial and commercial uses in other uses in cleaning 
and furniture care products including wood cleaners and gasket 
removers;
     Industrial and commercial use in ink, toner, and colorant 
products (printer ink; inks in writing equipment);
     Industrial and commercial use in other uses in soldering 
materials;
     Industrial and commercial use in other uses in fertilizer 
and other agricultural chemical manufacturing in processing aids and 
solvents;
     Consumer use in adhesives and sealants (glues and 
adhesives including lubricant adhesives); and
     Disposal.
    The following conditions of use do not drive EPA's unreasonable 
risk determination for NMP:
     Distribution in commerce;
     Consumer use in paint and coating removers;
     Consumer use in adhesive removers;
     Consumer use in paints and coatings in lacquers, stains, 
varnishes, primers and floor finishes;
     Consumer use in paint additives and coating additives not 
described by other codes in paints and arts and crafts paints;
     Consumer use in other uses in automotive car products;
     Consumer use in other uses in cleaning and furniture care 
products, including wood cleaners and gasket removers; and
     Consumer use in other uses in lubricant and lubricant 
additives, including hydrophilic coatings.
    EPA is not making condition of use-specific risk determinations for 
these conditions of use, is not issuing a final order under TSCA 
section 6(i)(1) for the conditions of use that do not drive 
unreasonable risk, and does not consider the revised risk determination 
for NMP to constitute a final agency action at this point in time.
    Consistent with the statutory requirements of TSCA section 6(a), 
EPA will propose a risk management regulatory action to the extent 
necessary so that NMP no longer presents an unreasonable risk. EPA 
expects to focus its risk management action on the conditions of use 
that drive the unreasonable risk. However, it should be noted that, 
under TSCA section 6(a), EPA is not limited to regulating the specific 
activities found to drive unreasonable risk and may select from among a 
suite of risk management requirements in section 6(a) related to 
manufacture (including import), processing, distribution in commerce, 
commercial use, and disposal as part of its regulatory options to 
address the unreasonable risk. As a general example, EPA may regulate 
upstream activities (e.g., processing, distribution in commerce) to 
address downstream activities (e.g., consumer uses) driving 
unreasonable risk, even if the upstream activities do not drive the 
unreasonable risk.

III. Summary of Public Comments

    EPA received a total of 22 public comments on the July 1, 2022, 
draft revised risk determination for NMP during the comment period that 
ended August 1, 2022, of which 20 were unique and responsive to the 
request for comments. Commenters included trade organizations, industry 
stakeholders, environmental groups, and non-governmental health 
advocacy organizations. A separate document that summarizes all 
comments submitted and EPA's responses to those comments has been 
prepared and is available in the docket for this notice (Ref. 10).

IV. Revision of the December 2020 NMP Risk Evaluation

A. Why is EPA revising the risk determination for the NMP risk 
evaluation?

    EPA is finalizing the revised risk determination for the NMP risk 
evaluation pursuant to TSCA section 6(b) and consistent with Executive 
Order 13990, (``Protecting Public Health and the Environment and 
Restoring Science to Tackle the Climate Crisis'') and other 
Administration priorities (Refs. 3, 4, 5, and 6). EPA is revising 
specific aspects of the first ten TSCA existing chemical risk 
evaluations in order to ensure that the risk evaluations better align 
with TSCA's objective of protecting health and the environment. For the 
NMP risk evaluation, this includes: (1) Making the risk determination 
in this instance based on the whole chemical substance instead of by 
individual conditions of use and (2) Emphasizing that EPA does not rely 
on the assumed use of PPE when making the risk determination.

B. What are the revisions?

    EPA is now finalizing the revised risk determination for the 
December 2020 NMP Risk Evaluation (Ref. 2) pursuant to TSCA section 
6(b). Under the revised determination (Ref. 1), EPA concludes that NMP, 
as evaluated in the risk

[[Page 77602]]

evaluation as a whole, presents an unreasonable risk of injury to 
health when evaluated under its conditions of use. This revision 
replaces the previous unreasonable risk determinations made for NMP by 
individual conditions of use, supersedes the determinations (and 
withdraws the associated order) of no unreasonable risk for the 
conditions of use identified in the TSCA section 6(i)(1) no 
unreasonable risk order, and clarifies the lack of reliance on assumed 
use of PPE as part of the risk determination.
    These revisions do not alter any of the underlying technical or 
scientific information that informs the risk characterization, and as 
such the hazard, exposure, and risk characterization sections are not 
changed, except to statements about PPE assumptions in section 2.4.1.1 
(Occupational Exposures Approach and Methodology) and 4.2.2 (Risk 
Estimation for Worker Exposures for Occupational Use of NMP). The 
discussion of the issues in this notice and in the accompanying final 
revision to the risk determination supersede any conflicting statements 
in the prior executive summary, and section 2.4.1.1 and section 4.2.2 
from the December 2020 NMP Risk Evaluation (Ref. 2) and the response to 
comments document (Ref. 11).
    The revised unreasonable risk determination for NMP includes 
additional explanation of how the risk evaluation characterizes the 
applicable OSHA requirements, or industry or sector best practices, and 
also clarifies that no additional analysis was done, and the risk 
determination is based on the risk characterization (section 4) of the 
December 2020 NMP Risk Evaluation (Ref. 2).

C. Will the revised risk determination be peer reviewed?

    The risk determination (section 5 of the December 2020 NMP Risk 
Evaluation (Ref. 2)) was not part of the scope of the Science Advisory 
Committee on Chemicals (SACC) peer review of the NMP risk evaluation. 
Thus, consistent with that approach, EPA did not conduct peer review of 
the final revised unreasonable risk determination for the NMP risk 
evaluation because no technical or scientific changes were made to the 
hazard or exposure assessments or the risk characterization.

V. Order Withdrawing Previous Order Regarding Unreasonable Risk 
Determinations for Certain Conditions of Use

    EPA is also issuing a new order to withdraw the TSCA section 
6(i)(1) no unreasonable risk order issued in section 5.4.1 of the 
December 2020 NMP Risk Evaluation (Ref. 2). This final revised risk 
determination supersedes the condition of use-specific no unreasonable 
risk determinations in the December 2020 NMP Risk Evaluation (Ref. 2). 
The order contained in section 5.5 of the revised risk determination 
(Ref. 1) withdraws the TSCA section 6(i)(1) order contained in section 
5.4.1 of the December 2020 NMP Risk Evaluation (Ref. 2). Consistent 
with the statutory requirements of section 6(a), the Agency will 
propose risk management action to address the unreasonable risk 
determined in the NMP risk evaluation.

VI. 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 physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Unreasonable Risk Determination for n-Methylpyrrolidone 
(NMP). December 2022.
2. EPA. Risk Evaluation for n-Methylpyrrolidone (NMP). December 
2020. EPA Document #740-R-18-009. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0081.
3. 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.
4. Executive Order 13985. Advancing Racial Equity and Support for 
Underserved Communities Through the Federal Government. Federal 
Register. 86 FR 7009, January 25, 2021.
5. Executive Order 14008. Tackling the Climate Crisis at Home and 
Abroad. Federal Register. 86 FR 7619, February 1, 2021.
6. Presidential Memorandum. Memorandum on Restoring Trust in 
Government Through Scientific Integrity and Evidence-Based 
Policymaking. Federal Register. 86 FR 8845, February 10, 2021.
7. EPA. Press Release; EPA Announces Path Forward for TSCA Chemical 
Risk Evaluations. June 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. EPA. Proposed Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register. 82 FR 
7562, January 19, 2017 (FRL-9957-75).
9. EPA. Final Rule; Procedures for Chemical Risk Evaluation Under 
the Amended Toxic Substances Control Act. Federal Register. 82 FR 
33726, July 20, 2017 (FRL-9964-38).
10. EPA. Response to Public Comments to the Revised Unreasonable 
Risk Determination; n-Methylpyrrolidone (NMP). December 2022.
11. EPA. Summary of External Peer Review and Public Comments and 
Disposition for n-Methylpyrrolidone (NMP). December 2020. Available 
at: https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0082.
12. Occupational Safety and Health Administration (OSHA). Top 10 
Most Frequently Cited Standards for Fiscal Year 2021 (Oct. 1, 2020, 
to Sept. 30, 2021). Accessed October 13, 2022. https://www.osha.gov/top10citedstandards.
13. OSHA. Permissible Exposure Limits--Annotated Tables. Accessed 
June 13, 2022. https://www.osha.gov/annotated-pels.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 13, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-27438 Filed 12-16-22; 8:45 am]
BILLING CODE 6560-50-P


