Mr. Dirk Helder April 30, 2002 April 30, 2002 helder. dirk@ epa. gov F 1 703 305 4610 Mr. Dirk Helder, Linuron Chemical Review Manager U. S. EPA OPP/ SRRD (7508C) 1921 Jefferson Davis Highway Room 266A, Crystal Mall #2 Arlington, VA 22202 4501 SUBJECT: LINURON TRED  RESPONSE TO DRAFT HED, RESIDUE AND DRINKING WATER CHAPTERS Dear Mr. Helder:

The purpose of this letter is to respond to the subject chapters received by GRIFFIN LLC on February 11, 2002. We have reviewed the documents and limited our responses to apparent discrepancies between the studies we have in hand and the draft chapters.

Response to: HED Chapter of the Linuron Tolerance Reassessment Eligibility Decision. PC Codes: 035506. Case 0047. DP Barcode D271950.

There are several discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published.

1) The first discrepancy is the statement on page 4 that linuron exhibits developmental concerns. On page 3 of the same document it states:

Developmental studies in the rat and rabbit showed no quantitative or qualitative susceptibility in the offspring. … These findings do not indicate increased susceptibility because increases in resorptions were marginal and there was no change in the number of live fetuses to corroborate the increase in post implantation losses.

This is in direct contradiction with the statements that there are developmental toxicity concerns. In addition, the acute dietary endpoint was `derived from the developmental toxicity study in the rat and is based on increases in post implantation loss and litter/ fetal resorptions." (page 5) Although the acute dietary endpoint is correctly set at 12.1 mg/ kg/ day, it should be based on the NOEL for maternal toxicity seen in this study at 12.1 mg/ kg/ day.

2) The second error was the use of the 3 generation rat study. This study was deemed `supplemental' because it was a non guideline study. Substantial effort was expended by DuPont, the former registrant, to upgrade this study in the late 1980's. The Agency, after multiple responses, would not consider this study as acceptable or guideline compliant (CAS # 004405, Record # 154,911, CAS# 004819, CAS# 005626, CAS# 008113, CAS# 008612). After a meeting held on July 22, 1987, a new 2 generation reproduction study in rats was required. No records of additional scientific reviews can be located which reverses this decision. This new 2 generation study was submitted with subsequent studies to elucidate questionable effects. This study with the amendments was accepted, therefore, this study should be used for regulatory decision making and the rejected study discounted. Mr. Dirk Helder April 30, 2002 Page 2 The report states on page 4:

A 3 generational study using rats showed reduced body weights and fertility, decreased pup survival, and decreased weanling body, liver and kidney weights, as well as liver atrophy. The Hazard Identification Assessment Review Committee (HIARC) determined that these results illustrate qualitative susceptibility in the rat offspring.

In the discussion of the 3 generational study in the HED Toxicology Disciplinary Chapter the LOEL for systemic toxicity was established at 125 ppm and the NOEL was set at 25 ppm. The offspring toxicity LOEL was established at 625 ppm with the NOAEL at 125 ppm. This was based on decreased pup survival and lower pup body weights. It is clear that this effect was at maternally toxic levels. This is NOT evidence of a qualitative susceptibility in rat offspring.

EPA's position was very clearly stated in the August 15, 1985 rebuttal comments from James N. Rowe. (Record Number 154,911). It states:

"It is apparent that gross and histopathological examinations of the adult rats were not performed by the registrant. Therefore, proper interpretation of the reproductive effects observed in the study cannot be performed."

In addition, meeting minutes from a discussion between DuPont and the Agency's scientists held on July 22, 1987 (in the public docket) make it clear that in addition to the lack of histopathological data, fewer than 20 animals per group were tested which were fewer than guideline specification.

Griffin LLC can only assume an error was made in reviewing the classification of the acceptable/ guideline designation or the study was re evaluated and given a new assessment. If there is a new review, the Agency has not notified the registrant. Regardless, a significant discrepancy exists.

3) The third major discrepancy is the determination of a `neurotoxicity' concern. There has never been an Agency concern for neurotoxicity induced by linuron. The Agency previously recognized this in that no acute or subchronic neurotoxicity studies were requested. Linuron has been shown to be an endocrine disruptor. This has never been in question. There is, however, a big difference between the weak anti androgenic activity elicited by linuron and `neuroendocrine' effects referred to by the Agency in this document. No data have been presented by the Agency either from registrant sponsored studies or from the literature which would be a basis for a neurotoxicity concern. This designation of "neuroendocrine effects" has no scientific basis and should be either deleted from the document or supported somewhere in the scientific documents. The request for a developmental neurotoxicity test is not supported by the Agency's own assessment of the science. (see discussion above as it relates to the developmental studies)

4) The fourth major discrepancy is the reference with Linuron (and subsequent regulatory action) to linuron as an inhalation concern. There is essentially no toxicity by the inhalation route. The LD50 is >218 mg/ L or 21.8 g/ M 3 . The MOEs calculated in the Linuron RED of March 1995 were all above 100 and of no concern. These were based on the NOELs (12.1 mg/ kg) from the rat developmental study for the short term assessment and the 2 generation reproduction study (1.25 mg/ kg/ day) for the intermediate term assessment. Because the occupational exposure to a pre emergent herbicide used once per season/ year will not exceed 30 days exposure, there is not a great inhalation risk concern driven by the use patterns. In addition, linuron is neither volatile as an active ingredient nor contains volatiles nor becomes volatile in its formulations. Given the lack of inhalation toxicity and Mr. Dirk Helder April 30, 2002 Page 3 potential for exposure, the request for a 28 day inhalation study is not supported. This is either in error or requires scientific justification.

Response to EPA Document: Linuron TRED Residue Chemistry Considerations There are two discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published.

5) Page 46. Miscellaneous Commodities "Cotton, seed and gin products For the gin byproducts field trials, information describing the type of equipment used for harvesting in the machine harvest trials must be submitted. In addition, additional cotton gin byproducts field trials must be conducted, such that the requirements of GLN 860.1000 (Table 1) for gin byproducts field trials are fulfilled, or a justification for the substitution of data from field trials reflecting hand harvesting must be submitted."

A response to the issues raised above was submitted to Mr. Tom Myers, Chemical Review Manager. The letter of transmittal is dated January 14, 2002 and was sent via FedEx on this date. Our records indicate that this response was received on January 16.

6) Page 47. Magnitude of the Residue in Processed Food/ Feed "The 2/ 94 RED and 2/ 95 RED Addendum concluded that additional data were required to upgrade an existing potato processing study (S. Knizner, 9/ 2/ 92); these data remain outstanding."

A response to the memorandum from Steven A. Knizer to Lois Rossi was submitted to the Agency on February 14, 2000. Our records show that the response was received by the Agency on February 18, 2000. The information requested for upgrading this study was included in the submittal.

Response to Linuron TRED, Drinking Water There are two discrepancies in the series of documents prepared to support the Tolerance Reassessment Eligibility Decision of Linuron. Many are basic to the decisions which will be made for additional studies and the risk assessment process. These need to be addressed before any of these reports are published.

Surface Water 7) Model used for estimating residues in drinking water The Agency used the IR PCA PRZM/ EXAM model that has never been validated and has been proven to grossly overestimate residues in drinking water. It is stated in the document that "Modeling results are higher than those from existing surface water monitoring data for linuron targeted to the pesticide use area". Percent Crop Area (PCA) was used in the modeling of linuron on carrots. PCA is only applicable to major crops and carrots in the San Joaquin –Tulare Basins is not considered a major crop. Data from the 1992 Census of Agriculture were used to generate the PCA's and recent changes in the agriculture sector has significantly impacted the distribution of crops throughout the US. We feel that the IR PCA PRZM/ EXAM model is not a valid modeling system for estimating residues in drinking water and that the inputs into the model are not valid. The results from this model misrepresent the actual residues that Mr. Dirk Helder April 30, 2002 Page 4 occur in drinking water. Monitoring data cited by the Agency much more accurately reflects linuron residues in drinking water.

Ground Water 8) The Agency recommended that 5 ppb of linuron be used in the drinking water assessment based on monitoring data cited.

It is recommended in this document that 5 ppb be used in the drinking water assessment in ground water. Data cited in the review show that the highest residue in drinking water was 5 ppb. We recommend that the Agency use in their drinking water assessment an average residue from the water monitoring data. Data cited by the Agency from a USGS NAWQA monitoring study show linuron residues were detected in only 0.11% of the 924 samples analyzed. The maximum concentration was 0.029 ppb. In another study cited, linuron residues were present in 29% of the 377 analyses. The highest residue from this monitoring study was 5 ppb. Again, the Agency is using a value that grossly overestimates linuron residues in drinking water. If an average residue value is used, then the estimated exposure would be <1 ppb.

Additional monitoring data can be found at the following website: http:// water. wr. usgs. gov/ pnsp/ pestgw/

In this monitoring program, water samples were collected from 1243 wells and 1849 aquifers located in agricultural areas. Linuron residues were detected in 0.16% of the wells and 0.05% of the aquifers. The maximum linuron residue detected in these water samples was 0.03 ppb. Water samples were also collected from 643 wells in urban areas and no residues were detected in any of the water samples analyzed.

Please advise if any additional draft Linuron chapters will be distributed.

Sincerely yours,

Wm. Ronald Landis, Ph. D. Consultant to GRIFFIN, LLC pc: Richard Collier, Ph. D., GRIFFIN, LLC Bill Tweedy, Ph. D., GRIFFIN, LLC Jimmy Lefiles, GRIFFIN, LLC Gail Arce, Ph. D., GRIFFIN, LLC


[Federal Register: May 21, 2009 (Volume 74, Number 97)]
[Notices]
[Page 23930-23931]
[DOCID:fr21my09-147]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0148]

Pipeline Safety: Potential Low and Variable Yield and Tensile
Strength and Chemical Composition Properties in High Strength Line Pipe

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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SUMMARY: PHMSA is issuing an advisory bulletin to owners and operators
of natural gas pipeline and hazardous liquid pipeline systems. This
bulletin advises pipeline system owners and operators of the potential
for high grade line pipe installed on projects to exhibit inconsistent
chemical and mechanical properties. Yield strength and tensile strength
properties that do not meet the line pipe specification minimums have
been reported. This advisory bulletin pertains to microalloyed high
strength line pipe grades, generally Grade X-70 and above. PHMSA
recently reviewed metallurgical testing results from several recent
projects indicating pipe joints produced from plate or coil from the
same heat may exhibit variable chemical and mechanical properties by as
much as 15% lower than the strength values specified by the pipe
manufacturer.

FOR FURTHER INFORMATION CONTACT: Alan Mayberry by phone at (202) 366-
5124 or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Federal pipeline safety regulations in 49 CFR Parts 192 and 195
require operators of natural gas transmission, distribution pipeline
systems, and hazardous liquids pipeline systems to use pipe
manufactured by a listed specification in the design of pipelines in
accordance with Sec. Sec.  192.7, 192.55(a), 192.105, and Sec. Sec.
195.3, 195.106, and 195.112.
    During pipeline construction in the late-fall of 2008, several
recently installed natural gas transmission pipeline systems
experienced field hydrostatic test failures or excessively expanded
pipe joints of large diameter, microalloyed high grade line pipe.
Metallurgical, mechanical and chemical composition tests of the line
pipe in these cases have shown pipe to have yield strengths, tensile
strengths and/or chemical compositions that did not meet the
requirements of the American Petroleum Institute, Specification for
Line Pipe--5L, (API 5L), 43rd edition for the specified pipe grade. API
5L, product specification level (PSL 2), specifies material
requirements in Section 6 and inspection and testing standards in
Section 9. Even though the pipe supplier provided the pipeline owner or
operator with documentation that the pipe that was delivered to the
owner met these minimum standards, substandard pipe properties were
found in some pipe joints. Specifically, PHMSA was made aware that some
of the line pipe that was installed in these projects had yield
strengths that were up to 15% below the listed API 5L specification
requirements for the specific pipe grade.
    Pipeline owners and operators should closely review the
manufacturing procedure specifications for the production and rolling
of the steel plate or coil that is to be used in the production of new
microalloyed high strength line pipe to ensure that pipe steel was
properly rolled into steel plate or coil prior to the pipe mill rolling
process. Pipeline owners and operators should request detailed
manufacturing procedure specifications (MPS) from the pipe manufacturer
as a basis for ensuring critical steel processing parameters such as
the detailed rolling schedule, including, but not limited to rolling
temperature, heating temperature and temperature uniformity, are
controlled throughout the steel rolling process.
    Mechanical property and chemical composition tests should be
conducted throughout the steel making, steel rolling and pipe
manufacturing process to ensure uniformity of chemical and

mechanical properties of the pipe prior to being shipped from the steel
and pipe rolling mills. Low yield and tensile strength test results are
defined as any test results below the minimum specified yield strength
ordered, and tensile strengths below those specified for the specified
grade. An example of pipe standard and grades includes API 5L, PSL 2,
X70 and X80; where X-70 corresponds to steel achieving a specified
minimum yield strength of 70,000 psi; and so on.

II. Advisory Bulletin ADB-09-01

    To: Owners and Operators of Hazardous Liquid and Natural Gas
Pipeline Systems.
    Subject: Potential Low and Variable Yield and Tensile Strength and
Chemical Composition Properties in High Strength Line Pipe.
    Advisory: The Federal pipeline safety regulations in 49 CFR Parts
192 and 195 require operators of natural gas transmission, gas
distribution, and hazardous liquids pipeline systems to use pipe
manufactured by a listed specification in the design of pipelines in
accordance with Sec. Sec.  192.7, 192.55 (a), 192.105, and Sec. Sec.
195.3, 195.106, and 195.112.
    PHMSA has identified an integrity issue with respect to
microalloyed high grade line pipe. Tests that have been conducted on
line pipe that has been installed in pipeline systems have shown that
some of the pipe material has yield strengths, tensile strengths, and/
or chemical compositions that do not meet the requirements of the
American Petroleum Institute, Specification for Line Pipe--5L, (API
5L), for PSL 2 and the specified pipe grade. Pipe joints produced from
plate or coil from the same heat may exhibit variable chemical and
mechanical properties. Yield strengths below the minimum specified
yield strength have been reported and yield strengths up to 15% lower
than the strength values on the pipe manufacturer produced mill test
report have also been reported. In some cases, the affected pipe may
successfully pass strength testing methods contained in current
specifications but may lead to a future pipeline integrity issue. The
presence of low yield strength line pipe installed in a pipeline system
may result in increased susceptibility to excessive pipe expansion or
rupture during the pre in-service field hydrostatic strength test.
    PHMSA wants to ensure that owners and operators of recently
constructed pipeline systems are aware of the need to investigate
whether their pipelines contain joints of pipe that do not meet minimum
specification requirements. Pipeline owners and operators should review
all MPS mill test reports and other appropriate documentation with
their pipe suppliers to determine if all specification requirements
have been met. Pipeline owners and operators should be aware that small
deviations in steel rolling schedule parameters can have a pronounced
effect on final mechanical properties. The MPS should provide adequate
information concerning process details and inspection methods to ensure
that the materials are uniform and will meet all specification
requirements.
    PHMSA advises pipeline owners and operators of in service pipelines
to review their pipe specifications, pipe steel making and rolling MPS,
pipe mill test reports, deformation tool results and all hydrostatic
test failure results for both mill and in place hydrostatic tests to
ensure that inconsistent mechanical and chemical properties are not
inherent in microalloyed line pipe grades on all API 5L--PSL 2, X70 and
X80 line pipe installed during recent construction projects.
    Pipeline owners and operators should conduct technical document
reviews on all high strength microalloyed line pipe installed during
this period, review hydrostatic test failures that occurred on
pipelines installed during this period and consider using methods to
detect pipe expansion such as running deformation tools that detect
expanded pipe in these systems if they have any knowledge, findings or
pipe history that lead them to believe their newly constructed high
grade line pipe systems contain line pipe joints that do not meet
specification requirements. Should a pipeline owner or operator have
knowledge of other high grade pipe vintages supplied at early dates
that are in their operating systems that may have this problem, they
should consider conducting reviews as described above with these
operating pipelines to ensure that operating pressures and anomaly
repair procedures are not being conducted outside of their 49 CFR Parts
192 and 195 Code parameters.

    Authority: 49 U.S.C. chapter 601 and 49 CFR 1.53.

    Issued in Washington, DC, on May 14, 2009.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. E9-11815 Filed 5-20-09; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77596-77602]
[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<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. 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)

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

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

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

(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;

     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

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 <IP_ADDRESS>
(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 <IP_ADDRESS> 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


[Federal Register Volume 87, Number 107 (Friday, June 3, 2022)]
[Notices]
[Pages 33873-33875]
[FR Doc No: 2022-11946]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0034]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of applications for exemption; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces receipt of applications from 22 individuals
for an exemption from the hearing requirement in the Federal Motor
Carrier Safety Regulations (FMCSRs) to operate a commercial motor
vehicle (CMV) in interstate commerce. If granted, the exemptions would
enable these hard of hearing and deaf individuals to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before July 5, 2022.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2022-0034 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number, FMCSA-2022-0034, in the keyword box, and
click ``Search.'' Next, sort the results by ``Posted (Newer-Older),''
choose the first notice listed, and click on the ``Comment'' button.
Follow the online instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m.
and 5 p.m.,

ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are 8:30 a.m. to 5 p.m., ET, Monday through Friday,
except Federal holidays. If you have questions regarding viewing or
submitting material to the docket, contact Dockets Operations, (202)
366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2022-0034), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov/docket?D=FMCSA-2022-0034. Next, sort the results by ``Posted (Newer-
Older),'' choose the first notice listed, click the ``Comment'' button,
and type your comment into the text box on the following screen. Choose
whether you are submitting your comment as an individual or on behalf
of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2022-0034, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The 22 individuals listed in this notice have requested an
exemption from the hearing requirement in 49 CFR 391.41(b)(11).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting the exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).
    On February 1, 2013, FMCSA announced in a Notice of Final
Disposition titled, ``Qualification of Drivers; Application for
Exemptions; National Association of the Deaf,'' (78 FR 7479), its
decision to grant requests from 40 individuals for exemptions from the
Agency's physical qualification standard concerning hearing for
interstate CMV drivers. Since that time the Agency has published
additional notices granting requests from hard of hearing and deaf
individuals for exemptions from the Agency's physical qualification
standard concerning hearing for interstate CMV drivers.

III. Qualifications of Applicants

Christopher Adams
    Mr. Adams, 29, holds a class C license in Iowa.
Jerritt Boehle
    Mr. Boehle, 51, holds a class D license in Illinois.
Nathan Bohannon
    Mr. Bohannon, 30, holds a class C license in Texas.
John Darr
    Mr. Darr, 32, holds a class D license in Tennessee.
Jeremy Earl
    Mr. Earl, 38, holds a class DM license in Illinois.
Taniko Graham
    Ms. Graham, 25, holds a class D license in Tennessee.
Rodney Henley
    Mr. Henley, 36, holds a class D license in Alabama.
Quincy Hicks
    Mr. Hicks, 57, holds a class D license in Virginia.
Omar Ibrahim
    Mr. Ibrahim, 41, holds a class D license in Minnesota.
Larry Mancill
    Mr. Mancill, 31, holds a class F license in Missouri.
Glenn McCormack
    Mr. McCormack, 39, holds a class D license in Illinois.

Carlos Morales
    Mr. Morales, 51, holds a class A license in Florida.
Steven Morris
    Mr. Morris, 24, holds a class C license in Texas.
Tisha Simmons
    Ms. Simmons, 46, holds a class C license in North Carolina.
Viramdeep Singh
    Mr. Singh, 28, holds a class A license in New York.
Joseph Stanford, III
    Mr. Stanford, 28, holds a class C license in Oregon.
Charles Stire
    Mr. Stire, 41, holds a class D license in Kentucky.
Amanda Sturdevant
    Ms. Sturdevant, 42, holds a class C license in Texas.
Robert Walker, Jr.
    Mr. Walker, 51, holds a regular operator's license in Washington.
Joshua Wayland
    Mr. Wayland, 35, holds a class D license in Illinois.
Kevin Young
    Mr. Young, 36, holds a class D license in Alabama.
Karisa Zapotocky
    Ms. Zapatocky, 29, holds a class C license in California.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated under the DATES
section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-11946 Filed 6-2-22; 8:45 am]
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[Federal Register: March 24, 2008 (Volume 73, Number 57)]
[Notices]
[Page 15530]
[DOCID:fr24mr08-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Ophthalmic Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 24 and 25, 2008,
from 8:30 a.m. to 5 p.m.
    Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD.
    Contact Person: Karen F. Warburton, Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: On April 24, 2008, the committee will discuss, make
recommendations, and vote on a premarket approval application,
sponsored by VisionCare Technologies, Inc., for an implantable
miniature telescope (IMT). The IMT, a visual prosthetic device, is
indicated for monocular implant in patients with stable, moderate to
profound central vision impairment due to bilateral central scotomas
associated with end-stage macular degeneration with geographic atrophy
or disciform scar, foveal involvement, and cataract. On April 25, 2008,
the committee will discuss general issues concerning the post market
experience with phakic intraocular lenses and laser-assisted in situ
keratomileusis (LASIK).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 15, 2008. Oral presentations from the public will be scheduled on
April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between
approximately 3:30 p.m. and 4 p.m.; and on April 25, 2008, between
approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m.
and 4 p.m. Those desiring to make formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 7, 2008. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 8, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management staff, at<PHONE_NUMBER>, at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 14, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-5810 Filed 3-21-08; 8:45 am]

BILLING CODE 4160-01-S