[Federal Register Volume 86, Number 13 (Friday, January 22, 2021)]
[Proposed Rules]
[Pages 6602-6611]
[FR Doc No: 2021-00456]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2020-0565; FRL-10019-39]

TSCA Section 21 Petition for Rulemaking; Reasons for Agency
Response; Denial of Requested Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document provides the reasons for the Environmental
Protection Agency's (EPA's) response to a petition it received under
the Toxic Substances Control Act (TSCA) from the Center for
Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy
Green, Toxic Free NC, and the NC Black Alliance on October 14, 2020.
Generally, the petitioners requested that EPA initiate a rulemaking
proceeding or issue an order under TSCA compelling health and
environmental effects testing on 54 Per- and Polyfluoroalkyl Substances
(PFAS) that the petitioners assert are manufactured by The Chemours
Company (Chemours) at its chemical production facility in Fayetteville,
North Carolina. The petitioners also request that EPA ask the National
Academy of Sciences to create an independent science panel to oversee
all aspects of the testing program requested by the petitioners. After
careful consideration, EPA denied the TSCA petition for reasons
discussed in this document.

DATES: EPA's response to this TSCA section 21 petition was signed
January 7, 2021.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0565, 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. 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
(202) 566-0280.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room are closed to visitors
with limited exceptions. The EPA/DC staff continue to provide remote
customer service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Daniel R. Ruedy, Data Gathering
and Analysis Division (7410M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action,
however, may be of particular interest to those persons who manufacture
(which includes import), distribute in commerce, process, use, or
dispose of one or more of the 54 Per- and Polyfluoroalkyl Substances
(PFAS) identified in the petition. Since other entities may also be
interested, the Agency 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?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA
to initiate a proceeding for the issuance, amendment, or repeal of a
rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth
the facts which it is claimed establish that it is necessary to
initiate the action requested. EPA is required to grant or deny the
petition within 90 days of its filing. If EPA grants the petition, the
Agency must promptly

commence an appropriate proceeding. If EPA denies the petition, the
Agency must publish its reasons for the denial in the Federal Register.
A petitioner may commence a civil action in a U.S. district court
seeking to compel initiation of the requested proceeding within 60 days
of a denial or, if EPA does not issue a decision, within 60 days of the
expiration of the 90-day period.

C. What criteria apply to a decision on a TSCA section 21 petition?

1. Legal Standard Regarding TSCA Section 21 Petitions
    TSCA section 21(b)(1) requires that the petition ``set forth the
facts which it is claimed establish that it is necessary'' to initiate
the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21
implicitly incorporates the statutory standards that apply to the
requested actions. Accordingly, EPA has relied on the standards in TSCA
section 21 and in the provisions under which actions have been
requested in evaluating this TSCA section 21 petition.
2. Legal Standard Regarding TSCA Section 4(a)(1)(A)(i)
    EPA must make several findings in order to require testing under
TSCA section 4(a)(1)(A)(i) through a rule or order. EPA must find that
the manufacture, distribution in commerce, processing, use, or disposal
of a chemical substance or mixture, or that any combination of such
activities, may present an unreasonable risk of injury to health or the
environment; that information and experience are insufficient to
reasonably determine or predict the effects of a chemical substance on
health or the environment; and that testing of the chemical substance
is necessary to develop the missing information. Further, TSCA section
4(h) requires EPA to reduce and replace the use of vertebrate animals
in the testing of chemical substances or mixtures, to the extent
practicable, scientifically justified, and consistent with the policies
of TSCA.
3. Legal Standard Regarding TSCA Section 26
    TSCA section 26(h) requires EPA, in carrying out TSCA sections 4,
5, and 6, to make a decision using ``scientific information, technical
procedures, measures, methods, protocols, methodologies, or models,
employed in a manner consistent with the best available science,''
while also taking into account six considerations, including the
relevance of information and any uncertainties. TSCA section 26(i)
requires that decisions under TSCA sections 4, 5, and 6 be ``based on
the weight of scientific evidence.'' TSCA section 26(k) requires that
EPA consider information that is reasonably available in carrying out
TSCA sections 4, 5, and 6.

II. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On October 14, 2020, Center for Environmental Health, Cape Fear
River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the
NC Black Alliance (petitioners) petitioned EPA to initiate a rulemaking
proceeding or issue an order under TSCA section 4(a)(1)(A)(i),
compelling health and environmental effects testing, including studies
of communities exposed to PFAS-contaminated drinking water, on 54 PFAS
that the petitioners assert are manufactured by The Chemours Company
(Chemours) at its chemical production facility in Fayetteville, North
Carolina. The petitioners also request that EPA ask the National
Academy of Sciences to create an independent science panel to oversee
all aspects of the testing program requested by the petitioners (Ref.
1).

B. What support did the petitioners offer?

    The petitioners assert that TSCA section 4(a)(1)(A)(i) requires EPA
to direct testing on a chemical substance or mixture if all three of
the following findings are made:
     The manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment;
     There is insufficient information and experience upon
which the effects of such manufacture, distribution in commerce,
processing, use, or disposal of such substance or mixture or of any
combination of such activities on health or the environment can
reasonably be determined or predicted; and
     Testing of such substance or mixture with respect to such
effects is necessary to develop such information.
1. May Present an Unreasonable Risk of Injury to Health or the
Environment
    The petitioners assert that the 54 PFAS ``may present an
unreasonable risk of injury to health or the environment'' because
there allegedly is substantial evidence that PFAS may be toxic,
pointing to the following documents:
     The Agency for Toxic Substances and Disease Registry's
(ATSDR's) draft 2018 Toxicological Profile for Perfluoroalkyls (Ref. 2)
and EPA's PFAS Action Plan (Ref. 3), as well as other literature, in
support of the contention that exposure to certain, specific PFAS are
associated with adverse health effects.
     EPA's Significant New Use Rule (SNUR) for Long-Chain
Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical
Substances (Ref. 4), which states ``[w]hile most studies to date have
focused primarily on PFOS, structure-activity relationship analysis
indicates that the results of those studies are applicable to the
entire category of PFAS, which includes PFOS. Available test data have
raised concerns about their potential developmental, reproductive, and
systemic toxicity.''
     EPA's Consent Order regarding DuPont Premanufacture
Notices (Ref. 5), which states in part ``[t]oxicity studies on the
analogs PFOA (perfluorooctanoic acid) and PFOS (perfluorooctanesulfonic
acid) indicate developmental, reproductive and systemic toxicity in
various species. Cancer may also be of concern. These factors, taken
together, raise concerns for potential adverse chronic effects in
humans and wildlife.''
    The petitioners conclude, based on the references provided, that
``all PFAS have the potential for causing the adverse health and
environmental effects linked to well-characterized substances like PFOS
and PFOA because of their common structural characteristics,'' and that
``there is a strong basis to conclude that the 54 PFAS covered by this
petition `may present an unreasonable risk of injury' '' (Ref. 1, pg.
18).
2. Insufficiency of Information
    The petitioners assert that for these 54 PFAS, there is
insufficient information and experience upon which the effects of such
manufacture, distribution in commerce, processing, use, or disposal of
such substance or mixture or of any combination of such activities on
health or the environment can reasonably be determined or predicted. To
support their assertion, the petitioners point to:
     ATSDR's draft 2018 Toxicological Profile for
Perfluoroalkyls (Ref. 2), which the petitioners assert underscores the
absence of toxicological data; and
     EPA's PFAS Action Plan (Ref. 3), which states ``[t]here
are many PFAS of potential concern to the public that may be found in
the environment. Most of these PFAS lack sufficient toxicity data to
inform our understanding of the potential for adverse human or
ecological effects.''

    On page 21 of their petition, the petitioners assert: ``[k]ey data
gaps include measurement of physical-chemical properties, methods of
analysis, assessment of partitioning, bioaccumulation, and degradation,
pharmacokinetics, and toxicity, especially for the endpoints commonly
observed for the better studied PFAS, such as liver toxicity, and
effects on the immune system, lipid metabolism, kidney, thyroid,
development, reproduction, and cancer. In addition, despite their
widespread detection in environmental media, ecotoxicity data are
generally lacking.''
3. Need for Testing
    The petitioners assert that the mechanisms of PFAS toxic effects
are not defined, and that in vitro assays or other predictive,
computational approaches are not validated or available. The
petitioners also request animal toxicity studies on three mixtures of
PFAS that are allegedly representative of exposure for residents in the
Cape Fear Watershed.
    Finally, the petitioners request ecotoxicity studies, and studies
of physical chemical properties and environmental fate and transport,
which they say EPA ``has previously determined are necessary because of
the widespread presence and mobility of PFAS in environmental media.''
4. Testing Framework and Specific Studies
    The petitioners propose a testing approach that they call for
Chemours to perform. The list of 54 PFAS was divided into Tier 1
substances for which there is ``known human exposure based on detection
in blood, food, or drinking water,'' and Tier 2 substances for which
``human exposure is probable based on detection in environmental
media'' (Ref. 1, pg.12). The testing approach includes human health
effects studies in experimental animals, animal studies on PFAS
mixtures, studies of communities exposed to PFAS-contaminated drinking
water, human half-life studies, physical-chemical properties and fate
and transport studies, and ecotoxicity testing.

III. Background Considerations: Review of EPA Actions, Activities, and
Regulations Relating to PFAS

    To understand EPA's reasons for denying the petitioners' requests,
it is important to first review the details of EPA's ongoing actions
involving PFAS. EPA is committed to supporting states, tribes, and
local communities in addressing challenges with PFAS. As a part of this
effort, EPA is already taking action to identify solutions to address
PFAS in the environment. Examples of such ongoing actions are detailed
in this unit.

A. PFAS Action Plan: Program Update

    In May 2018, EPA convened a two-day National Leadership Summit on
PFAS that brought together more than 200 federal, state, and local
leaders to discuss steps to address PFAS. The Summit set the following
goals: Evaluate the need for a maximum contaminant level for PFOA and
PFOS in drinking water, evaluate designating PFOA and PFOS as hazardous
substances, issue groundwater cleanup guidances for PFOA and PFOS, and
develop toxicity values for GenX and perfluorobutane sulfonic acid
(PFBS). Following the Summit, EPA interacted with more than 1,000
people during PFAS-focused community engagement events in Exeter, New
Hampshire; Horsham, Pennsylvania; Colorado Springs, Colorado;
Fayetteville, North Carolina; and Leavenworth, Kansas, as well as
through a roundtable in Kalamazoo, Michigan, and an event with tribal
representatives in Spokane, Washington. As a result of these meetings
and building on the goals identified at the Summit and the
approximately 120,000 public comments received by the agency, EPA
developed the PFAS Action Plan, which was issued in February 2019 (Ref.
3).
    The PFAS Action Plan is the first multi-media, multi-program,
national research, management, and risk communication plan to address
an emerging contaminant like PFAS. The PFAS Action Plan outlines the
tools EPA is developing to, among other things, address PFAS in
drinking water, identify and clean up PFAS contamination, expand
monitoring of PFAS, increase PFAS scientific research, and exercise
effective enforcement tools. The Action Plan outlines EPA's commitment
to take a wide variety of actions to address this emerging contaminant
in both short-term and long-term timeframes. Together, these efforts
are helping EPA and its partners identify and better understand PFAS
contaminants generally, clean up current PFAS contamination, prevent
future contamination, and effectively communicate risk with the public.
In February 2020, EPA issued the PFAS Action Plan: Program Update
(available at https://www.epa.gov/pfas/pfas-action-plan-program-update-february-2020) to provide an update on all of the actions taken and
work completed in the year since the PFAS Action Plan was issued. As it
continues to implement the PFAS Action Plan, EPA is committed to
coordinating closely with multiple entities, including other federal
agencies, states, tribes, local governments, water utilities, industry,
and the public.

B. Interim Strategy for PFAS in Federally Issued National Pollutant
Discharge Elimination System (NPDES) Permits

    EPA's Office of Water (OW) is currently leading multiple actions in
the PFAS Action Plan that will help the Agency better understand and
effectively manage risk from exposure to PFAS. These OW-led actions
include developing analytical methods for detecting PFAS in drinking
water and other environmental media, evaluating PFAS treatment
techniques, conducting data collection and analysis to evaluate the
need for regulations to control PFAS discharges from certain categories
of point sources, understanding PFAS exposure from various
environmental media, and evaluating statutory and regulatory mechanisms
to manage adverse human health and environmental impacts from PFAS
exposure.
    While OW's work is advancing, a need for an interim strategy to
address point source discharges of PFAS in EPA-issued NPDES permits was
identified. On February 6, 2020, a workgroup was established to develop
an interim NPDES permitting strategy to address PFAS in EPA-issued CWA
section 402 permits. The workgroup was charged with exploring options
for how to address these pollutants while the CWA framework for
addressing PFAS discharges pursuant to the NPDES program is under
development. The workgroup's goal was to develop a strategy that would
serve to guide the Agency's CWA NPDES permitting approach on an interim
basis across the EPA Regions as informed by input from state partners.
Each of the ten EPA Regions appointed a representative to the
workgroup.
    To develop potential recommendations for an interim PFAS NPDES
strategy, the workgroup conducted a thorough review of the NPDES
permitting process, with a specific focus on PFAS. This included
examining CWA section 402 authorities and permit writing practices to
understand where unregulated contaminants, such as PFAS, may fit into
the permit development process; analyzing existing state-issued NPDES
permits with PFAS monitoring requirements (identified through EPA's
NPDES Integrated Compliance Information System (ICIS)) to

understand the prescribed analytical methods for detecting PFAS,
monitoring frequency, and detection benchmarks in current permits; and
obtaining input and perspectives from state partners. In November 2020,
EPA issued a memo detailing an interim NPDES permitting strategy for
PFAS. This strategy is being implemented for EPA-issued NPDES permits.

C. Workshop on Federal Government Human Health PFAS Research With the
National Academies of Sciences, Engineering and Medicine

    On October 26-27, 2020, the National Academies of Science,
Engineering, and Medicine (NASEM) held a Workshop on Federal Government
Human Health PFAS Research. This workshop was the result of
collaboration between EPA, the U.S. Department of Defense (DoD), the
U.S. Department of Agriculture (USDA), and the U.S. Department of
Health and Human Services (HHS) and will help further coordinate PFAS
research across the federal government. Aggressively addressing PFAS
has been an active and ongoing priority for this Administration, and
the goal of the workshop was to discuss ongoing federal research and
data gaps. Following the workshop, NASEM will compile a report
summarizing the discussion and views of workshop participants on how to
ensure that the federal research program for PFAS is robust and focused
on addressing the highest priority human health research. Workshop
proceedings will be published in early 2021.

D. Safe Drinking Water Act (SDWA) Actions for PFOA and PFOS

    EPA has taken a number of actions under SDWA, consistent with the
PFAS Action Plan and its statutory and regulatory authorities. In 2016,
EPA established health advisories for PFOA and PFOS (Ref. 6) based on
the Agency's assessment of the latest peer-reviewed science to provide
drinking water system operators, and state, tribal and local officials
who have the primary responsibility for overseeing these systems, with
information on the health risks of these chemicals, so they can take
the appropriate actions to protect their residents. To provide
Americans, including the most sensitive populations, with a margin of
protection from a lifetime of exposure to PFOA and PFOS from drinking
water, EPA established the health advisory levels at 70 parts per
trillion.
    EPA is committed to following the regulatory process established
under SDWA and supporting states and public water systems as they
determine the appropriate steps to reduce exposure to PFOA and PFOS in
drinking water.

E. National Primary Drinking Water Regulation for PFOA and PFOS

    On March 10, 2020, EPA published a notice (85 FR 14098, FRL-10005-
88) seeking comment on proposed determinations to regulate PFOA and
PFOS. EPA is considering the public comments on this notice and expects
to issue final regulatory determination in January 2021. If EPA issues
final determinations to regulate PFOA and PFOS, SDWA requires that the
EPA publish a proposed regulation within 24 months of the final
determination and promulgate a final regulation within 18 months of
proposal (SDWA allows the Agency to extend that final rule deadline by
9 months).
    Under the third Unregulated Contaminant Monitoring Rule (UCMR 3)
(85 FR 26072, FRL-9660-4), from 2013 to 2015, EPA required almost 5,000
public water systems to monitor for six PFAS (see https://www.epa.gov/dwucmr/third-unregulated-contaminant-monitoring-rule). The results of
this monitoring were used by EPA in making the proposed regulatory
determination for PFOA and PFOS. EPA has committed to monitoring for
more PFAS in the UCMR 5 and at lower levels than was possible under the
UCMR 3. EPA expects to publish a proposed UCMR 5 in January 2021.

F. PFOA Stewardship Program

    EPA launched the PFOA Stewardship Program (Ref. 7) in January, 2006
because of concerns about the impact of PFOA and long-chain PFAS on
human health and the environment, including concerns about their
persistence, presence in the environment and in the blood of the
general U.S. population, long half-life in people, and developmental
and other adverse effects in laboratory animals.
    By March 1, 2006, the eight major companies in the PFAS industry
submitted commitments to the PFOA Stewardship Program. Specifically,
these companies committed to reducing PFOA from facility emissions and
product content by 95 percent no later than 2010, and to work toward
eliminating PFOA from emissions and product content no later than 2015.
The companies participating in the PFOA Stewardship Program were global
companies with business operations in the United States and other
countries.
    To meet the program goals, most companies stopped the manufacture
and import of long-chain PFAS, and then transitioned to alternative
chemicals. Other companies exited the PFAS industry altogether. All
participating companies state that they met the PFOA Stewardship
Program goals. In July 2020 EPA codified and expanded the impact of the
PFOA Stewardship program through the issuance of the long chain PFAS
SNUR, as discussed in Unit III.H.

G. Addition of Certain PFAS to the Toxics Release Inventory (TRI)
Regulations

    The National Defense Authorization Act for Fiscal Year 2020 (NDAA)
(Pub. L. 116-92) added certain PFAS to the list of chemicals required
to be reported to the TRI and established a 100-pound reporting
threshold for these substances. EPA's TRI is an important tool that
provides the public with information about the use of certain chemicals
by tracking their management and associated activities. U.S. facilities
in different industry sectors must report annually how much of each
chemical is released to the environment and/or managed through
recycling, energy recovery, and treatment. TRI helps support informed
decision-making by companies, government agencies, non-governmental
organizations and the public. For example, EPA uses TRI information to
understand releases and potential exposures to chemicals being assessed
under TSCA.
    In June 2020, the Agency published a final rule (85 FR 37354, June
22, 2020; FRL-10008-09) that updated the regulations to reflect the
addition of these PFAS to the TRI by the NDAA. Per the NDAA
requirements, the PFAS additions became effective as of January 1,
2020. Reporting for these PFAS will be due to EPA by July 1, 2021, for
calendar year 2020 data. By July 31, 2021, EPA expects to release raw
data concerning the TRI-listed PFAS from information collected.
Additionally, the NDAA provides a framework for additional PFAS to be
added automatically to the TRI list on January 1 of the year following
certain EPA actions (NDAA section 7321(c)). For example, the NDAA
automatically adds a PFAS to the TRI list in response to the EPA
finalizing a toxicity value for it.

H. Regulatory Actions Under TSCA

    EPA has taken a range of regulatory actions under TSCA to address
potential exposures and/or risks associated with manufacturing,
processing, and use of PFAS. EPA's New Chemicals program reviews
alternatives for PFOA and related chemicals before they enter the
marketplace to identify whether the range of toxicity, fate and
bioaccumulation issues that have caused past concerns with
perfluorinated substances may be

present in order to ensure that the new chemicals do not present an
unreasonable risk to health or the environment.
    TSCA Section 5(a) SNURs can be used to require notice to EPA before
chemical substances and mixtures are used in new ways that might create
concerns. Under TSCA section 5(a), EPA can determine that a use of a
chemical substance is a ``significant new use.'' EPA must make this
determination by rule after considering all relevant factors, including
those listed in TSCA section 5(a)(2):
     Projected volume of manufacturing and processing of a
chemical substance.
     Extent to which a use changes the type or form of exposure
of humans or the environment to a chemical substance.
     Extent to which a use increases the magnitude and duration
of exposure of humans or the environment to a chemical substance.
     Reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    Once EPA designates a use of a chemical substance as a significant
new use, TSCA section 5(a) requires persons to submit a significant new
use notice (SNUN) to EPA at least 90 days before they manufacture
(including import) or process the chemical substance for that use. The
SNUN obligates EPA to assess risks that may be associated with that
significant new use, including risks to potentially exposed or
susceptible subpopulations identified as relevant by EPA under the
conditions of use; make a determination under the statute; and, if
appropriate, regulate the proposed activity before it occurs.
    EPA has issued the following SNURs for PFOS and PFAS:
     On March 11, 2002, EPA issued a final SNUR (Ref. 8) for 13
PFAS specifically included in the voluntary phase out of PFOS by 3M
that took place between 2000 and 2002.
     On December 9, 2002, EPA issued a final SNUR (Ref. 9) for
75 PFAS specifically included in the voluntary phase out of PFOS by 3M
that took place between 2000 and 2002.
     On October 9, 2007, EPA issued a final SNUR (Ref. 10) for
183 PFAS that were on the public TSCA Inventory and have the
characteristic PFAS chemical structure of a perfluorinated carbon chain
(Rf) greater than, or equal to, C5 attached to an SO2 group
connected to the rest of the molecule. In addition, the proposal also
included those chemicals with Rf ranges of perfluorinated carbon chains
shorter than C5, and greater than C5, for example, C4-C12 and C6-C12.
     On October 22, 2013, EPA issued a final SNUR (Ref. 11) for
certain PFOA-related chemicals as part of carpets, a category of
potentially harmful chemicals once used on carpets to impart soil,
water, and stain resistance.
     On July 27, 2020, EPA issued a final SNUR (Ref. 12) for
certain PFOA-related chemicals. The SNUR modifies the requirements for
a subset of LCPFAC chemical substances in the existing SNUR at 40 CFR
721.10536 in the following ways: (1) Designating manufacturing
(including importing) or processing of LCPFAC chemical substances
listed in the list of LCPFAC chemical substances for any use that was
no longer ongoing after December 31, 2015, as a significant new use;
and (2) Designating manufacturing (including importing) or processing
of PFOA or its salts, which are considered LCPFAC chemical substances,
and all other LCPFAC chemical substances for any use not ongoing as of
January 21, 2015, the date on which the proposed rule was published, as
a significant new use. For this final SNUR, EPA also made an exemption
at 40 CFR 721.45(f) inapplicable for persons who import LCPFAC chemical
substances listed in the list of LCPFAC chemical substances in this
unit and PFOA or its salts as part of a surface coating on articles
because there is reasonable potential for exposure to LCPFAC chemical
substances, including PFOA, if these chemical substances are
incorporated as surface coatings in articles and then imported.
    In addition, in December 2020, EPA issued draft guidance (Ref. 13)
for public comment outlining which imported articles are covered by the
July 2020 final rule for certain long-chain PFAS. After considering
comments, EPA intends to issue the final guidance promptly.
    PFOS was not reported as manufactured (including imported) into the
United States as part of the 2012 Chemical Data Reporting (CDR) effort
or the previous collection effort in 2006. CDR requires manufacturers
(including importers) to report if they meet certain production volume
thresholds, generally 25,000 lbs at a single site. The last time PFOS
manufacture was reported to EPA as part of this collection effort was
2002; nonetheless, there are some limited ongoing uses of PFOS (see 40
CFR 721.9582).

I. Increasing Research and Understanding PFAS

    Building on the work outlined in the February 2019 PFAS Action
Plan, the Agency expanded its research efforts and capabilities by
launching the PFAS Innovative Treatment Team (PITT) in spring 2020. The
PITT was a full-time, multi-disciplinary research team that
concentrated their efforts and expertise on a single problem for six
months: How to remove, destroy, and test PFAS-contaminated media and
waste. The PITT's goals were to:
     Assess current and emerging destruction methods being
explored by EPA, universities, other research organizations, and
industry;
     Explore the efficacy of destruction methods while
considering by-products to avoid creating new environmental hazards;
and
     Evaluate destruction methods' feasibility, performance,
and costs to validate potential solutions.
    This work initiated under the PITT will add practical knowledge to
EPA's efforts under the PFAS Action Plan. States, tribes, and local
governments will be able to use this information to select the approach
that best fits their circumstances, leading to greater confidence in
cleanup operations and safer communities.
    Besides the innovative work of PITT, EPA and its researchers
continue to work hard in many other areas to help the nation address
PFAS and protect public health. This work includes:
     Validating methods to detect and quantify PFAS in various
environmental media, such as water, air, and biosolids. EPA has already
released a number of these methods, including Methods 533 and 537.1
that together can measure 29 PFAS in drinking water;
     Evaluating treatment technologies that remove PFAS from
drinking water. For example, researchers are investigating the
effectiveness of point-of-use systems and have recently published
research on commercially available systems that use both reverse
osmosis and granular activated carbon;
     Developing standard human health toxicity reference values
for certain PFAS. For example, Agency scientists are working on a
toxicity assessment for PFBS, GenX chemicals, and five other PFAS that
will help states, tribes, and local communities understand the toxicity
of these substances so that they can make more informed choices to
protect the public's health;
     Providing technical assistance to states and tribes as
they work to address a variety of PFAS challenges; and
     Funding external researchers to better understand the
potential impacts of PFAS on water quality and availability in rural
communities and agricultural operations across the United States.

IV. Disposition of TSCA Section 21 Petition

A. What was EPA's response?

    After careful consideration, EPA has denied the petition. A copy of
the Agency's response, which consists of the letter to the petitioners
and this document, is posted on the EPA petition website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#reporting. The response, the petition (Ref. 1) and other information
is available in the docket for this TSCA section 21 petition (see
ADDRESSES).
    The denial is not based on lack of concern with PFAS. In fact,
EPA's high concern for these chemicals is detailed in Unit III. of this
document. EPA is leading the national efforts to understand PFAS and
reduce PFAS risks to the public through implementation of its PFAS
Action Plan and through active engagement and partnership with other
federal agencies, states, tribes, industry groups, associations, local
communities, and the public. Instead, EPA finds the petitioners have
not met their burden under TSCA section 21, as explained in Unit IV.B.
of this document.

B. What was EPA's reason for this response?

    In considering the petition within the statutory 90-day petition
review period, EPA evaluated the information presented or referenced in
the petition and considered that information in the context of the
applicable authorities and requirements contained in TSCA sections 4,
21, and 26. Also, notwithstanding that the burden is on the petitioners
to present ``the facts which it is claimed establish that it is
necessary'' for EPA to initiate the rule or issue the order sought, EPA
nonetheless also evaluated relevant information that was reasonably
available to the Agency during the 90-day petition review period.
    As detailed extensively in the units that follow, EPA finds the
petitioners have not provided the facts necessary for the Agency to
determine for each of the 54 PFAS that existing information and
experience are insufficient and testing of such substance or mixture
with respect to such effects is necessary to develop such information.
These deficiencies, among other findings, are detailed in this
document.
1. Insufficient Information and Experience
    The petition does not set forth the facts necessary to demonstrate
that there is ``insufficient information and experience'' for each of
the 54 PFAS. The petitioners state, in part, ``[f]or the 54 PFAS, the
sufficiency of available information should be determined by comparing
available data with the known adverse effects of other PFAS. The goal
should be to conduct a scientifically sound assessment of each of the
54 chemicals for the critical toxic endpoints that have been identified
in studies on PFOS, PFOA and other well-characterized studies'' (Ref.
1, pg. 21). However, the petitioners do not provide evidence that they
conducted an assessment to support a finding of insufficient
information and experience.
    The petitioners instead point to broad statements in the EPA PFAS
Action Plan, such as ``[t]here are many PFAS of potential concern to
the public that may be found in the environment. Most of these PFAS
lack sufficient toxicity data to inform our understanding of the
potential for adverse human or ecological effects'' (Ref. 3, pg. 31).
The petitioners base the fate and transport studies they request on
EPA's PFAS Action Plan, which the petitioners quote as stating
``information for many PFAS sources, fate and transport, and human and
ecological exposure is sparse, both spatially and temporally'' (Ref. 3,
pg. 31). However, the PFAS Action Plan broadly states only that such
information for ``many PFAS sources'' is sparse; nowhere does it state
or conclude that such information is sparse for each of the 54 PFAS the
petitioners identify. To further demonstrate that the information and
experience on the 54 PFAS is allegedly insufficient, the petitioners
cite ATSDR's 2018 Toxicological Profile for perfluoroalkyls, which the
petitioners acknowledge ``identifies numerous critical data gaps for
PFAS as a class'' (emphasis added). The ATSDR 2018 Toxicological
Profile for perfluoroalkyls remains in draft form and discusses
information on 14 perfluoroalkyl compounds, none of which are among the
54 the petitioners identify. Importantly, the ATSDR 2018 Toxicological
Profile further states that ``[t]he term `perfluoroalkyls' used
throughout the toxicological profile is referring to these 14 compounds
and the information may not be applicable to other perfluoroalkyl
compounds'' (Ref. 2, pg. 1). Despite this qualifying statement, the
petitioners proceed to state without reference or additional
explanation that ``[t]he 54 substances covered by this petition fit
this pattern'' (Ref. 1, pg. 21). This extrapolation is fundamentally
important to the petitioners' argument, yet there are no facts in the
petition to support the statement. The petitioners are not clear as to
what ``pattern'' the 54 PFAS fit, and no other sources are provided.
    Absent any factual support in the petition, EPA finds that mere
reference to these broad statements from the EPA PFAS Action Plan and
ATSDR's 2018 Toxicological Profile for perfluoroalkyls does not provide
the facts necessary for the Agency to determine there is insufficient
information or experience for these 54 PFAS.
    To further characterize this baseline deficiency, EPA performed a
cursory search of public literature and databases for reasonably
available information on any of the 54 PFAS identified by the
petitioners. Representative findings of this cursory review are
summarized as follows:
     On June 8, 1987, EPA issued a Final Test Rule for
Fluoroalkenes (Ref. 14) requiring testing for certain health effects
for four fluoroalkenes, two of which are among the 54 PFAS the
petitioners identify: Hexafluoropropylene (CAS No. 116-15-4) and
tetrafluoroethylene (CAS No. 116-14-3). The petitioners do not identify
this test rule and the testing it required, nor do the petitioners
explore and explain why the testing the rule ordered did not generate
the health effects data the petitioners are now requesting.
     EPA's web-based CompTox Chemistry Dashboard integrates
various types of data for curated substances linked to chemical
structures, including physicochemical, environmental fate and
transport, exposure, usage, in vivo toxicity, and in vitro bioassay
data (Ref. 15). A query for some of the 54 PFAS in CompTox returned
physical/chemical property and hazard data. For example, CompTox has
published experimental averages for melting point, boiling point, water
solubility, and vapor pressure, and some hazard data and sources for
tetrafluoroethylene (CAS No. 116-14-3). CompTox also has published some
hazard data for hexafluoropropylene (CAS No. 116-15-4) and
perflouromethylperfluorovinyl ether (CAS No. 1187-93-5). Finally, some
physical/chemical data for perfluoro (4-methyl-3, 6- dioxaoct-7-ene)
sulfonyl fluoride (CAS No. 16090-14-5) are also readily available. The
petitioners mention none of these data, nor have they provided the
facts necessary to show that the information in CompTox is
insufficient.
     ChemView provides the public access to reports and dataset
information including data submitted to EPA, EPA Assessments and
Actions, and data provided by other EPA Offices and federal
organizations (Ref. 16). A query for each of the 54 PFAS in

ChemView returned records for 17 of the 54 PFAS. For example, for
perflouromethylperfluorovinyl ether (CAS No. 1187-93-5), a substantial
risk report is available from DuPont Haskell Global Centers on
reproduction/developmental toxicity screening tests (OECD 422/OPPTS
870.3650, one of the methods identified in the petitioners' testing
program) in rats (Ref. 17). The petitioners do not mention this report,
nor do they explain why the report fails to provide the data being
sought. In this way, the petitioners once again have not provided the
facts necessary to show that the information in ChemView is
insufficient.
     Tetrafluoroethylene (CAS No. 116-14-3) is pre-registered
under the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) regulation. The European Chemicals Agency (ECHA) has
compiled chemical/physical property data (partition coefficient,
potential for bioaccumulation, etc.) for this PFAS. Hexafluoropropylene
(CAS No. 116-15-4) is also pre-registered under REACH, and ECHA has
compiled some chemical/physical property data for this PFAS. The
petitioners mention none of these data, nor have they provided the
facts necessary to show that this information is insufficient.
    TSCA section 21 requires the petitioner, not EPA, to ``set forth
the facts which it is claimed establish that it is necessary to issue,
amend, or repeal a rule under TSCA sections 4, 6, or 8, or an order
under TSCA sections 4 or 5(e).'' Because EPA, upon a cursory review,
has been able to easily identify existing, reasonably available
information not mentioned in the petition, the petitioners have failed
in carrying their burden of setting forth facts which are necessary to
demonstrate that there is insufficient information, thereby
necessitating the requested action.
    For one of the 54 PFAS, identified only as N1AF, the petitioners
provide no structurally-descriptive chemical name, structure, or
molecular formula. Absent such identifying information, the petitioners
have not provided the facts necessary to determine whether there is
``insufficient information or experience'' for this chemical.
    Because the petitioners are seeking tests for each of the 54 PFAS,
the petitioners must set forth facts that establish it is necessary to
pursue the rule or issue the order the petitioners seek under TSCA
section 4. The petitioners must affirmatively demonstrate, through
facts, that there is ``insufficient information and experience'' for
each of the 54 PFAS. For the reasons described in this document, EPA
finds the petition does not set forth facts necessary to demonstrate
``insufficient information and experience'' for each of the 54 PFAS,
and has therefore not demonstrated that the rule or order requested is
necessary.
2. Testing of Such Substance or Mixture With Respect to Such Effects Is
Necessary To Develop Such Information
    The petitioners do not demonstrate ``testing of such substance or
mixture with respect to such effects is necessary to develop such
information.'' EPA finds that the petitioners failed to address ongoing
testing and data collections for some of the 54 PFAS, thereby failing
to set forth facts that are necessary to establish there is a need for
the testing sought in the petition. This research may provide
information that overlaps with testing the petitioners requested, which
would render the information unnecessary under TSCA section
4(a)(1)(A)(i)(III). Testing, both planned and underway, on some of the
54 PFAS that the petitioners identify is described in this unit:
     Five of the 54 PFAS have been subjected to all Tier 1 in
vitro, toxicokinetic, and clearance studies: Hepatotoxicity,
developmental toxicity, immunotoxicity, mitochondrial toxicity,
developmental neurotoxicity, endocrine disruption, general toxicity,
intrinsic hepatic clearance, plasma protein binding (PPB), and renal
reuptake. These studies are ongoing and results are expected by April
2021. Data are expected to be available via the PFAS Dashboard by the
end of June 2021.
     An additional six of the 54 PFAS have results from some
Tier 1 in vitro testing. Two have been included in systematic evidence
mapping (SEM), a systematic review approach used to identify available
data and characterize knowledge gaps.
     Three of the 54 PFAS have in vivo data identified from a
non-EPA source.
    In addition, the following studies are planned or in process by
EPA's Office of Research and Development (ORD).
     ORD will test for nuclear receptor and stress gene
responses of a PFAS library in HepG2 cells. This research will apply a
high-throughput assay for transcription factor activation to screening
the first and second PFAS screening sets totaling 150 samples.
Additional samples may be added to meet developing needs. This assay
platform contains known targets of several PFAS including the estrogen
receptor and peroxisome proliferator-activator receptors, as well as
many other potential targets. Well-studied PFAS such as PFOA and PFOS
will be included to help put findings for data-poor chemicals in better
context. Data sets will support development of read-across and category
approaches for this class of chemicals.
     Bioactivity of PFAS as determined using gene expression
and in vitro cellular pathology is another area of ongoing research at
EPA. This research will apply broad-based high-content screening assays
to characterize the bioactivity of a set of PFAS in multiple human cell
types. The resulting dataset will contribute to an overall assessment
of the effects of PFAS on important physiological functions that
overlap with effects measured in the testing the petitioners requested.
     ORD will also conduct high-throughput in vitro testing of
PFAS to fill data gaps and refine structural and mechanistic groupings.
This project falls under the Human Health Testing/Toxicokinetics
research area that will generate and analyze a large data set on ~150
PFAS using a variety of New Approach Methodologies (NAMs) in support of
EPA's mission to manage and regulate PFAS. This research effort will
add a dataset of NAMs testing results for 15 PFAS. Selection of these
15 chemicals will be driven by the initial analysis of the 150
chemicals and provide the ability to fill identified data gaps and
potentially test hypotheses developed from the initial analysis.
Testing of these 15 PFAS will include transcription factor activity
profiling; estrogen-dependent cell proliferation; high-content,
cellular phenotypic imaging; high-throughput transcriptomics; zebrafish
embryo development; and developmental neurotoxicity. The results will
support the overarching EPA PFAS research to: (1) Develop a
hierarchical scheme of chemical structural categories that are enriched
by NAM data; (2) Use categories as predefined neighborhoods to evaluate
degree of concordance in NAM results within categories and across
categories as a means to infer in vivo toxicity; (3) Predict
categorization of larger PFAS inventory and read-across coverage; and
(4) Recommend further in vivo testing for PFAS categories.
     In the FY2020 Further Consolidated Appropriations Act
(Pub. L. 116-94), Congress appropriated funds for EPA to address
research needs in support of designating PFAS as hazardous substances
under CERCLA. The research needed to help support this designation
include: Chemical and physical characteristics of PFAS; Toxicity and
kinetic information; environmental prevalence; Manufacturing and use

information; and Information on the regulatory status of PFAS. This
ongoing research will add significantly to currently available hazard
information for PFAS that could be used for this designation, as well
as for risk assessment use broadly by Program Offices.
    NDAA section 7351 amended TSCA section 8(a) to include a one-time
reporting event of PFAS manufactured (including imported) in any year
since January 1, 2011. TSCA section 8(a)(7) authorizes EPA to collect
``[a]ll existing information concerning the environmental and health
effects of such substance or mixture.'' Under this rule, EPA may
collect information that overlaps with some of the information
requested by petitioners. A final TSCA section 8(a) rule for these PFAS
must be issued by January 1, 2023, and EPA has initiated the relevant
rulemaking process for the proposed rule that is expected to be issued
in 2021.
    The petitioners also call for an epidemiologic study consisting of
100,000 participants from communities exposed to PFAS-contaminated
drinking water. A similar, multi-site health study is being implemented
through the Centers for Disease Control and Prevention and ATSDR
cooperative agreements. As ATSDR states, ``[i]nformation learned from
the multi-site study will help all communities in the U.S. with PFAS
exposures, including those that were not part of the study.'' The
petitioners mention this multi-site study but provide no analysis of
overlap or what testing might be duplicative with what is proposed and
thus might not be necessary, whether based on community
characteristics, demographics, specific PFAS or mixture, or levels of
exposure.
    For some of the 54 PFAS, only a degradant is detected in the Cape
Fear River per the information provided by petitioners, not the parent
chemical for which the petitioners have requested testing. The
petitioners have not identified why it is necessary to test the parent
chemicals and not the degradants actually detected in the Cape Fear
River. For example, the petitioners do not demonstrate that testing of
the parent chemical would identify effects relevant to the degradants.
    The petitioners specifically identify and acknowledge that ``5 of
the 54 listed chemicals in this petition are also designated for
testing in the Chemours North Carolina consent decree. These tests
would not need to be replicated in response to this petition'' (Ref. 1,
pg. 30). EPA finds this avoidance of duplicative testing tacitly
acknowledges that for these five PFAS, testing is not necessary to
develop information on health or environmental effects. The
petitioners' attempt to avoid duplicative testing as a result of the
Chemours North Carolina consent decree, but no other duplicative
testing, further emphasizes their failure to address readily available
information concerning the other activities EPA has identified in this
unit.
3. Class-Based Approach to Testing
    TSCA section 4(h)(1)(B)(ii) ``encourage[s]'' EPA to consider ``the
grouping of 2 or more chemical substances into scientifically
appropriate categories in cases in which testing of a chemical
substance would provide scientifically valid and useful information on
other chemical substances in the category.'' Accordingly, EPA is
currently investigating ways to group similar PFAS by likeness into
subcategories for purposes of research, data collection, hazard
determinations, and other activities (Ref. 18). EPA and the National
Toxicology Program collaborated to construct a PFAS screening library
subset composed of 75 PFAS on a structural category basis and
considerations such as structural diversity within a category, data
availability, and read-across category-level weight (e.g., value of
substance for anchoring read-across trends within a category, serving
as an analog); four of the 54 PFAS the petitioners identify are
included in this subset (Ref. 19). The petitioners mention this effort,
but incorrectly state that just two of the 54 PFAS the petitioners
cover are included in the EPA testing (Ref. 1, pg. 22).
    The petitioners take the opposite approach, requesting testing on
each of the 54 PFAS individually. The petitioners fail to address why a
class-based approach is not appropriate, while also indirectly
referring to the efforts to address PFAS as a class. For example, the
petitioners allege that conclusions about all 54 PFAS can be based on
the ATSDR 2018 Toxicological Profile even though none of the 54 PFAS
are addressed in the toxicological profile, and concedes that the ATSDR
2018 Toxicological Profile ``identifies numerous critical data gaps for
PFAS as a class'' (emphasis added). Additionally, among the references
allegedly supporting the assertion that PFAS present serious health and
environmental concerns, the petitioners cite a commentary entitled
``Scientific Basis for Managing PFAS as a Chemical Class'' (Ref. 20).
This commentary acknowledges PFAS ``demand a more efficient and
effective approach'' when it comes to testing and seeks to ``provide
scientific justification for why a class-based approach is appropriate
and necessary for all PFAS.'' Because the petitioners acknowledge the
54 PFAS share similarities with other members of the class, and the
petitioners do not explore these similarities as a means of
streamlining the extent of the testing requested, or to inform the
petitioners' ``tiered screening and testing process,'' EPA finds the
petitioners have not provided the facts necessary to determine, for
each of the 54 PFAS, that ``testing of such substance or mixture with
respect to such effects is necessary to develop such information.''
Therefore, they have not demonstrated that the rule or order they
requested is necessary.
4. Practicability of National Academy of Sciences Oversight
    The petitioners also request that the National Academy of Sciences
(NAS) oversee all aspects of the proposed testing program. EPA finds
such an oversight arrangement is not within the scope of what a TSCA
section 21 petitioner can request when seeking the initiation of a rule
or the issuance of an order under TSCA section 4. Further, projects and
studies must meet certain conditions for the NAS to accept private
funding. As an example, NAS does not generally oversee studies where
the study sponsor would have a direct financial interest in the outcome
of the testing program. EPA is not in a position to require NAS to
oversee the testing requested by the petitioners, and the petitioners
provide no administrative or organizational procedures for
implementation.
5. Selection of PFAS for Health and Environmental Effects Testing
    Attachment 2 of the petition divides the 54 PFAS at issue into Tier
1 substances ``for which there is known human exposure based on
detection in blood, food or drinking water,'' and Tier 2 substances
``for which human exposure is probable based on detection in
environmental media.'' However, the petitioners do not set forth facts
showing that for all 40 PFAS it ranks as Tier 2 substances, ``human
exposure is probable based on detection in environmental media'' or
that ``a strong inference of exposure can be drawn from their presence
in surface water, stormwater, wastewater, sediment, groundwater, soil,
private wells, and/or air emissions'' (Ref. 1, pg. 19). The petitioners
support their assertion that some of the Tier 2 PFAS were detected in
environmental media with two studies (Ref. 21, 22); for nine of these,
no other studies are provided for

inclusion based on presence in environmental media (Ref. 1, Attachment
2). Three of these nine PFAS were not directly detected in the two
studies. Further, for some of these nine PFAS, only degradant products
were detected in the Cape Fear River; the parent compounds the
petitioners specifically identify for testing were not. Thus, for nine
of the 54 PFAS, the petitioners provide weak or no evidence for
presence in environmental media upon which to base its ``strong
inference of exposure'' assertion (Ref. 1, pg. 19).
6. Scientific Standards
    EPA finds the petitioners have not evaluated the quality of the
data they have provided or indicated how they conducted their searches,
evaluated the quality of the sources, or indicated what gaps were
located and then explained why the specific tests requested, as
compared to others, would provide the data being sought. Such an
evaluation is necessary for EPA to conduct the considerations under
TSCA section 26(h).
7. Vertebrate Testing
    TSCA section 4(h) requires that EPA reduce and replace the use of
vertebrate animals in the testing of chemical substances under TSCA
section 4. EPA must consider ``as appropriate and to the extent
practicable and scientifically justified, reasonably available existing
information, including (i) Toxicity information; (ii) Computational
toxicology and bioinformatics; and (iii) High-throughput screening
methods and the prediction models of those methods.''
    The testing program the petitioners request would require testing
on vertebrates. For example, OCSPP Test Guidelines 850.2300, 870.3650,
and 870.7800, among other test guidelines, require vertebrate testing.
Due to the number of PFAS involved and tests requested, the
petitioners' request would require testing on a large number of
vertebrates. Yet, as previously discussed, the petition fails to
provide reasonably available existing toxicity information on the 54
PFAS, and as such the petition has not provided sufficient facts for
EPA to consider reasonably available existing information and encourage
and facilitate the use of test methods that reduce or replace the use
of vertebrates, group chemical substances as appropriate to reduce the
use of vertebrates, and facilitate the formation of consortia for
jointly conducted testing.

C. What was EPA's conclusions?

    EPA denied the request to initiate a rule or issue an order under
TSCA section 4 because the TSCA section 21 petition does not set forth
the facts necessary for the Agency to determine for each of the 54 PFAS
that existing information and experience are insufficient and testing
of such substance or mixture with respect to such effects is necessary
to develop such information. Therefore, the petitioners have not
demonstrated that the rule or order they requested is necessary.

V. 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
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. Center for Environmental Health, Cape Fear River Watch, Clean
Cape Fear, Democracy Green, Toxic Free NC, The NC Black Alliance to
Andrew Wheeler, Administrator, Environmental Protection Agency.
Petition to Require Health and Environmental Testing Under the Toxic
Substances Control Act on Certain PFAS Manufactured by Chemours in
Fayetteville, North Carolina. October 13, 2020.
    2. Agency for Toxic Substances and Disease Registry (ATSDR).
Notice; Availability of Draft Toxicological Profile:
Perfluoroalkyls. Federal Register. 83 FR 28849, June 21, 2018
(Docket No. ATSDR-2015-0004).
    3. EPA. EPA's Per- and Polyfluoroalkyl Substances (PFAS) Action
Plan. EPA 823R18004. February 14, 2019. https://www.epa.gov/pfas/epas-pfas-action-plan.
    4. EPA. Proposed Rule; Long-Chain Perfluoroalkyl Carboxylate and
Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use
Rule. Federal Register. 80 FR 2885, January 21, 2015 (FRL-9915-63).
    5. EPA. Consent Order regarding DuPont Premanufacture Notices
P08-508 and P09-509. (2009). https://chemview.epa.gov/chemview/proxy?filename=sanitized_consent_order_p_08_0508c.pdf.
    6. EPA. Notice of Availability; Lifetime Health Advisories and
Health Effects Support Documents for Perfluorooctanoic Acid and
Perfluorooctane Sulfonate. Federal Register. 81 FR 33250, May 25,
2016 (FRL-9946-91-OW).
    7. EPA. Fact Sheet: 2010/2015 PFOA Stewardship Program.
Washington, DC: US Environmental Protection Agency, Office of
Pollution Prevention and Toxics. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program.
    8. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New
Use Rule. Federal Register. 67 FR 11008, March 11, 2002 (FRL-6823-
6).
    9. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New
Use Rule. Federal Register. 67 FR 72854, December 9, 2002 (FRL-7279-
1).
    10. EPA. Final Rule; Perfluoroalkyl Sulfonates; Significant New
Use Rule. Federal Register. 72 FR 57222, October 9, 2007 (FRL-8150-
4).
    11. EPA. Final Rule; Perfluoroalkyl Sulfonates and Long-Chain
Perfluoroalkyl Carboxylate Chemical Substances; Final Significant
New Use Rule. Federal Register. 78 FR 62443, October 22, 2013 (FRL-
9397-1).
    12. EPA. Final Rule; Long-Chain Perfluoroalkyl Carboxylate and
Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use
Rule. Federal Register. 85 FR 45109, July 27, 2020 (FRL-10010-44).
    13. EPA. Draft Compliance Guide for Imported Articles Containing
Surface Coatings Subject to the Long-Chain Perfluoroalkyl
Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances
Significant New Use Rule; Notice of Availability and Request for
Comment. Federal Register. 85 FR 81466, December 16, 2020 (FRL-
10017-86).
    14. EPA. Final Rule; Fluoroalkenes; Final Test Rule. Federal
Register. 52 FR 21516, June 8, 1987 (FRL-3214-8).
    15. Williams, A.J., Grulke, C.M., Edwards, J. et al. The CompTox
Chemistry Dashboard: a community data resource for environmental
chemistry. Journal of Cheminformatics. 9, 61. 2017.
    16. EPA. Introduction to ChemView. May 28, 2020. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/introduction-chemview.
    17. DuPont Haskell Global Centers to 8(e) Coordinator, Office of
Pollution Prevention and Toxics, Environmental Protection Agency.
Substantial Risk Report for 3,3,3-Trifluoromethyl-1,2,2-
trifluorovinyl ether, CAS #1187-93-5. November 8, 2007. https://chemview.epa.gov/chemview/proxy?filename=2007-11-8EHQ-07-16360B_8ehq_1107_16360b.pdf.
    18. EPA. EPA and Partners Describe a Chemical Category
Prioritization Approach to Select 75 PFAS for Testing using New
Approach Methods. February 26, 2019. https://www.epa.gov/sciencematters/epa-and-partners-describe-chemical-category-prioritization-approach-select-75-pfas.
    19. Patlewicz, G. et al. A Chemical Category-Based
Prioritization Approach for Selecting 75 Per- and Polyfluoroalkyl
Substances (PFAS) for Tier Toxicity and Toxicokinetic Testing.
Environmental Health Perspectives 127(1). January 11, 2019. https://doi.org/10.1289/EHP4555.
    20. Kwiatkowski, C. et al. Scientific Basis for Managing PFAS as
a Chemical Class. Environmental Science & Technology Letters.
7,8:532-543. 2020. https://doi.org/10.1021/acs.estlett.0c00255.
    21. Strynar, M. et al. Identification of Novel Perfluoroalkyl
Ether Carboxylic Acids

(PFECAs) and Sulfonic Acids (PFESAs) in Natural Waters Using
Accurate Mass Time-of-Flight Mass Spectrometry (TOFMS).
Environmental Science & Technology. 49: 11622-116302015. https://pubs.acs.org/doi/abs/10.1021/acs.est.5b01215.
    22. McCord, J. and M. Strynar. Identification of Per- and
Polyfluoroalkyl Substances in the Cape Fear River by High Resolution
Mass Spectrometry and Nontargeted Screening. Environmental Science &
Technology 53(9): 4717-4727. 2019. https://doi.org/10.1186/s13321-017-0247-6.

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

    Dated: January 7, 2021.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-00456 Filed 1-21-21; 8:45 am]
BILLING CODE 6560-50-P