[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39511-39517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14108]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0743; FRL-9943-01-OCSPP]


n-Methylpyrrolidone (NMP); Draft Revision to Toxic Substances 
Control Act (TSCA) Risk Determination; Notice of Availability and 
Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and seeking public comment on a draft revision to the 
risk determination for the n-methylpyrrolidone (NMP) risk evaluation 
issued under TSCA. The draft 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. In this draft revision to the risk determination 
EPA finds 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 draft revised risk determination 
does not reflect an assumption that all workers always appropriately 
wear personal protective equipment (PPE). EPA understands that there 
could be occupational safety protections in place at 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 OSHA standards, or 
their employers are out of compliance with OSHA standards, or because 
OSHA has not issued a permissible exposure limit (PEL) (as is the case 
for NMP). This revision, when final, would supersede the condition of 
use-specific no unreasonable risk determinations in the December 2020 
NMP risk evaluation (and withdraw the associated order) and would make 
a revised determination of unreasonable risk for NMP as a whole 
chemical substance.

DATES: Comments must be received on or before August 1, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-EPA-HQ-OPPT-2016-0743, using 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 and 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) 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?

    This action is directed to the public in general. This action may, 
however, 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 draft revision to the risk 
determination, EPA has not attempted to describe all the specific 
entities that may be affected by this action.

[[Page 39512]]

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 non-risk 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 non-risk 
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 is reconsidering the risk determinations in the 
December 2020 NMP Risk Evaluation.

C. What action is EPA taking?

    EPA is announcing the availability of and seeking public comment on 
a draft revision to the risk determination for the risk evaluation for 
NMP under TSCA, which was initially published in December 2020 (Ref. 
1). EPA is specifically seeking public comment on the draft revision to 
the risk determination for the risk evaluation where the agency intends 
to determine that NMP, as a whole chemical, presents an unreasonable 
risk of injury to health when evaluated under its conditions of use. 
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 would revise and replace section 
5 of the risk evaluation for NMP where the findings of unreasonable 
risk to health were previously made for the individual conditions of 
use evaluated. EPA would also withdraw the order issued previously for 
11 conditions of use previously determined not to present unreasonable 
risk.
    This revision would be consistent with EPA's plans to revise 
specific aspects of the first ten TSCA chemical risk evaluations in 
order to ensure that the risk evaluations better align with TSCA's 
objective of protecting health and the environment. Under the draft 
revision, removing the assumption that workers always and appropriately 
wear PPE (see Unit II.C.) in making the whole chemical risk 
determination for NMP would result in three additional conditions of 
use to the original 26 driving the unreasonable risk determination for 
NMP. Additionally, for five conditions of use, acute effects in 
addition to chronic effects would now drive the unreasonable risk to 
workers. Overall, 29 of the 37 conditions of use EPA evaluated would 
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 
risk evaluation (Ref. 2).

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

II. Background

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

    In 2016, as directed by TSCA section 6(b)(2)(A), EPA chose the 
first ten chemical substances to undergo risk evaluations under the 
amended TSCA. These chemical substances are asbestos, 1-bromopropane, 
carbon tetrachloride, C.I. Pigment Violet 29, HBCD, 1,4-dioxane, 
methylene chloride, NMP, perchloroethylene (PCE), and trichloroethylene 
(TCE).
    From June 2020 to January 2021, EPA published risk evaluations on 
the first ten chemical substances, including for NMP in December 2020. 
The risk evaluations included individual unreasonable risk 
determinations for each condition of use evaluated. EPA issued 
determinations that particular conditions of use did not present an 
unreasonable risk by order under TSCA section 6(i)(1).
    In accordance with Executive Order 13990 (Ref. 3) and other 
Administration priorities (Refs. 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

[[Page 39513]]

unreasonable risks and thereby help ensure the protection of human 
health and the environment (Ref. 7). To that end, EPA is reconsidering 
two key aspects of the risk determinations for NMP published in 
December 2020. First, following a review of specific aspects of the 
December 2020 NMP risk evaluation, EPA proposes that making an 
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 to NMP under the statute and implementing 
regulations. Second, EPA proposes that the risk determination should be 
explicit that it does not rely on assumptions regarding the use of 
personal protective equipment (PPE) in making the unreasonable risk 
determination under TSCA section 6, even though some facilities might 
be using PPE as one means to reduce workers exposures; rather, the use 
of PPE would be considered during risk management as appropriate.
    Separately, EPA is conducting a screening approach to assess 
potential 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). 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 final 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 for 
a more robust assessment of these pathways for NMP and to identify if 
there are risks that were unaccounted for in the NMP risk evaluation. 
While this analysis is underway, EPA is not incorporating the 
screening-level approach into this draft revised unreasonable risk 
determination. If the results suggest there is additional risk, EPA 
will determine if the risk management approaches being contemplated for 
NMP will protect against these risks or if the risk evaluation will 
need to be formally supplemented or revised.
    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 the risk evaluations and is incorporating new 
policy direction in a surgical manner, while being mindful of the 
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.
    The proposed risk evaluation procedural rule was premised on the 
whole chemical approach to making an unreasonable risk determination 
(Ref. 8). 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.'' (Ref. 8).
    The proposed rule, however, was unambiguous on the point that an 
unreasonable risk determination would be for the chemical substance as 
a whole, even if based on a subset of uses. (See Ref. 8 at pgs. 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 pg. 7480).
    The final risk evaluation procedural rule (Ref. 9) stated: ``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.'' (See also 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 in each risk evaluation (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 
procedural rule, which stated that EPA will make individual risk 
determinations for all conditions of use identified in the scope. (Ref. 
9 at pg. 33744).
    In contrast to this portion of the preamble of the final risk 
evaluation procedural 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 earlier 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

[[Page 39514]]

in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which 
explains 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. 8 at pg. 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, as further 
explained in this notice, EPA proposes 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 multiple conditions of use (spanning across 
most aspects of the chemical lifecycle--from manufacturing (including 
import), processing, commercial and industrial use, consumer use, and 
disposal) for health of workers and consumers and the 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 risk evaluation) 
would be based on the existing risk characterization section of the 
risk evaluation (section 4 of the risk evaluation) and would not 
involve additional technical or scientific analysis. The discussion of 
the issues presented in this Federal Register notice and in the 
accompanying draft revision to the risk determination would supersede 
any conflicting statements in the prior NMP risk evaluation and the 
response to comments document (Ref. 10). With respect to the NMP risk 
evaluation, EPA intends to change the risk determination to a whole 
chemical approach without considering the use of PPE and does not 
intend to amend, nor does a whole chemical approach require amending, 
the underlying scientific analysis of the risk evaluation in the risk 
characterization section of the risk evaluation. 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).
    EPA is announcing the availability of and seeking public comment on 
the draft superseding unreasonable risk determination for NMP, 
including a description of the risks driving the unreasonable risk 
determination under the conditions of use for the chemical substance as 
a whole. For purposes of TSCA section 6(i), EPA is making a draft risk 
determination on NMP as a whole chemical. Under the proposed revised 
approach, the ``whole chemical'' risk determination for NMP would 
supersede the no unreasonable risk determinations for NMP that were 
premised on a condition-of-use-specific approach to determining 
unreasonable risk. When finalized, EPA's revised unreasonable risk 
determination would also contain an order withdrawing the TSCA section 
6(i)(1) order in section 5.4.1 of the December 2020 NMP risk 
evaluation.

C. What revision does EPA propose 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 all 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 considered 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., 
Occupational Safety and Health Administration (OSHA) requirements for 
protection of workers).
    For the December 2020 NMP risk evaluation, EPA assumed based on 
information provided by public comments and safety data sheets of NMP 
that workers use PPE--specifically, respirators with an APF 10 and 
gloves with a 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 or 
properly use PPE, although it does not question the public comments 
received regarding the occupational safety practices often 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 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 (workers and occupational non-
users) 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

[[Page 39515]]

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 
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 or 
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 practices 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.
    Therefore, EPA proposes to make 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 EPA 
finds unreasonable risk for purposes of TSCA notwithstanding OSHA 
requirements.
    In accordance with this approach, EPA is proposing the draft 
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) 
would be considered during the risk management phase as appropriate. 
This would represent a change from the approach taken in the 2020 risk 
evaluation for NMP and EPA invites comments on this draft change to the 
NMP risk determination. 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, when those 
measures would address an 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 would 
result in three additional conditions of use driving EPA's unreasonable 
risk determination for NMP as a whole chemical. The three conditions of 
use affected by this change are: industrial and commercial use in ink, 
toner, and colorant products; industrial and commercial use in other 
uses in 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 would now 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) (Ref. 1).
    The draft revision to the risk determination would clarify that EPA 
does not rely on the assumed use of PPE when making the risk 
determination for the whole substance. EPA is requesting comment on 
this potential change.

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 did EPA reach about the risks of NMP in the 2020 
TSCA risk evaluation and what conclusions is EPA proposing to reach 
based on the whole chemical approach and not assuming the use of PPE?

    In the 2020 risk evaluation, EPA determined that NMP presents an 
unreasonable risk to health under the following conditions of use:
     Domestic manufacture;
     Manufacture (import);

[[Page 39516]]

     Processing as a reactant or intermediate in plastic 
material and resin manufacturing and other non-incorporative 
processing;
     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;
     Consumer use in adhesives and sealants (glues and 
adhesives including lubricant adhesives); and
     Disposal.
    Under the proposed whole chemical approach to the NMP risk 
determination, the unreasonable risk from NMP would continue to be 
driven by risk from those same conditions of use. In addition, by 
removing the assumption of PPE use in making the whole chemical risk 
determination for NMP, three conditions of use in addition to the 
original 26 would drive the unreasonable risk:
     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.
    Overall, 29 conditions of use out of the 37 evaluated would drive 
the NMP whole chemical unreasonable risk determination.

III. Revision of the December 2020 Risk Evaluation

A. Why is EPA proposing to revise the risk determination for the NMP 
risk evaluation?

    EPA is proposing to revise the 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, 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 the draft revision: (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 draft revisions?

    EPA is releasing a draft revision of the risk determination for the 
NMP risk evaluation pursuant to TSCA section 6(b). Under the revised 
determination, EPA preliminarily conclude that NMP, as evaluated in the 
risk evaluation as a whole, presents an unreasonable risk of injury to 
health under its conditions of use. This revision would replace the 
previous unreasonable risk determinations made for NMP by individual 
conditions of use, supersede the determinations (and withdraw 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 
clarify the lack of reliance on assumed use of PPE as part of the risk 
determination.
    These draft 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 the extent that 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), of the NMP risk evaluation would be superseded. The discussion of 
the issues in this notice and in the accompanying draft revision to the 
risk determination would supersede any conflicting statements in the 
prior executive summary and sections 2.4.1.1 and 4.2.2 from the NMP 
risk evaluation and the response to comments document (Refs. 2 and 10). 
Additional policy changes to other chemical risk evaluations, including 
any consideration of potentially exposed or susceptible subpopulations 
and/or inclusion of additional exposure pathways, are not necessarily 
reflected in these draft revisions to the risk determination.

C. Will the draft revised risk determination be peer reviewed?

    The risk determination (section 5 in the December 2020 risk 
evaluation) was not part of the scope of the peer review of the NMP 
risk evaluation by the Science Advisory Committee on Chemicals (SACC). 
Thus, consistent with that approach, EPA does not intend to conduct 
peer review of the draft revised unreasonable risk determination for 
the NMP risk evaluation because no technical or scientific changes will 
be made to the

[[Page 39517]]

hazard or exposure assessments or the risk characterization.

D. What are the next steps for finalizing revisions to the risk 
determination?

    EPA will review and consider public comment received on the draft 
revised risk determination for the NMP risk evaluation and issue a 
final revised NMP risk determination. If finalized as drafted, EPA 
would also issue a new order to withdraw the TSCA section 6(i)(1) no 
unreasonable risk order issued in Section 5.4.1 of the 2020 NMP risk 
evaluation. This final revised risk determination would supersede the 
December 2020 risk determinations of no unreasonable risk. Consistent 
with the statutory requirements of TSCA section 6(a), the Agency would 
then propose risk management actions to address the unreasonable risk 
determined in the NMP risk evaluation.

IV. 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. Draft Revised Unreasonable Risk Determination for NMP, 
Section 5, June 2022.
2. EPA. Risk Evaluation for n-Methylpyrrolidone (NMP). EPA Document 
#740-R-18-009. December 2020. 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. Summary of External Peer Review and Public Comments and 
Disposition for n-Methylpyrrolidone (NMP). December 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0082.

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

    Dated: June 27, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-14108 Filed 6-30-22; 8:45 am]
BILLING CODE 6560-50-P


