Notice2022-14108
n-Methylpyrrolidone (NMP); Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment
Primary source
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Published
July 1, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39511-39517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Clara Hull, 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: <a href="/cdn-cgi/l/email-protection#9df5e8f1f1b3fef1fceffcddf8edfcb3faf2eb"><span class="__cf_email__" data-cfemail="bad2cfd6d694d9d6dbc8dbfadfcadb94ddd5cc">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#63373020224e2b0c170f0a0d06230613024d040c15"><span class="__cf_email__" data-cfemail="c99d9a8a88e481a6bda5a0a7ac89acb9a8e7aea6bf">[email protected]</span></a>.
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
<a href="http://regulations.gov">regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/comments.html">https://www.epa.gov/dockets/comments.html</a>.
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:
<bullet> Domestic manufacture;
<bullet> Manufacture (import);
[[Page 39516]]
<bullet> Processing as a reactant or intermediate in plastic
material and resin manufacturing and other non-incorporative
processing;
<bullet> Processing for incorporation into a formulation, mixture,
or reaction product in multiple sectors;
<bullet> Processing for incorporation into articles--in lubricants
and lubricant additives in machinery manufacturing;
<bullet> Processing for incorporation into articles in paint
additives and coating additives not described by other codes in
transportation equipment manufacturing;
<bullet> Processing for incorporation into articles as a solvent
(which become part of product formulation or mixture), including in
textiles, apparel, and leather manufacturing;
<bullet> Processing for incorporation into articles in other
sectors, including in plastic product manufacturing;
<bullet> Processing in recycling;
<bullet> Processing for repackaging (wholesale and retail trade);
<bullet> Industrial and commercial use in paints, coatings, and
adhesive removers;
<bullet> Industrial and commercial use in paints and coatings in
lacquers, stains, varnishes, primers, and floor finishes, powder
coatings (surface preparation);
<bullet> 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;
<bullet> Industrial and commercial use paint additives and coating
additives not described by other codes in computer and electronic
product manufacturing in semiconductor manufacturing;
<bullet> Industrial and commercial use paint additives and coating
additives in multiple manufacturing sectors;
<bullet> Industrial and commercial use as a solvent (for cleaning
or degreasing) in electrical equipment, appliance and component
manufacturing;
<bullet> Industrial and commercial use as a solvent (for cleaning
or degreasing) in electrical equipment appliance and component
manufacturing in semiconductor manufacturing;
<bullet> 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);
<bullet> 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;
<bullet> Industrial and commercial use in other uses in anti-freeze
and de-icing products, automotive care products, and lubricants and
greases;
<bullet> Industrial and commercial use in metal products not
covered elsewhere and lubricant and lubricant additives including
hydrophilic coatings;
<bullet> Industrial and commercial uses in other uses in laboratory
chemicals;
<bullet> Industrial and commercial uses in other uses in lithium
ion battery manufacturing;
<bullet> Industrial and commercial uses in other uses in cleaning
and furniture care products including wood cleaners and gasket
removers;
<bullet> Consumer use in adhesives and sealants (glues and
adhesives including lubricant adhesives); and
<bullet> 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:
<bullet> Industrial and commercial use in ink, toner, and colorant
products (printer ink; inks in writing equipment);
<bullet> Industrial and commercial use in other uses in soldering
materials;
<bullet> 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. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0081">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0081</a>.
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. <a href="https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations">https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations</a>.
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. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0082">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0082</a>.
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
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