6602 Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this proposed action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Is not expected to be an Executive 

Order 13771 regulatory action because 

this action is not significant under 

Executive Order 12866; 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where EPA or an 

Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: December 2, 2020. 

Dennis Deziel, 

Regional Administrator, EPA Region 1. 

[FR Doc. 2021–00458 Filed 1–21–21; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 Perand 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 (202) 566–1744, 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: (202) 

564–7974; email address: ruedy.daniel@

epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

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 


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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.’’ 


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On page 21 of their petition, the 

petitioners assert: ‘‘[k]ey data gaps 

include measurement of physicalchemical 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, physicalchemical 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 twoday 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 shortterm 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/pfasaction-plan-program-update-february2020) 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 


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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-unregulatedcontaminant-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, nongovernmental 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 


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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 PFOArelated 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 PFAScontaminated 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 pointof-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. 


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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-chemicalsunder-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 wellcharacterized 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 


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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 proliferatoractivator receptors, as well as many 

other potential targets. Well-studied 

PFAS such as PFOA and PFOS will be 

included to help put findings for datapoor chemicals in better context. Data 

sets will support development of readacross 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 highthroughput 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 readacross 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 


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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 multisite 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 categorylevel 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 classbased 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 classbased 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 


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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-managingchemicals-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-andmanaging-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/epaand-partners-describe-chemical-categoryprioritization-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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules 6611 

(PFECAs) and Sulfonic Acids (PFESAs) in 

Natural Waters Using Accurate Mass Timeof-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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 54 

[GN Docket No. 20–32; Report No. 3165; 

FRS 17372] 

Petitions for Reconsideration of Action 

in Rulemaking Proceeding 

AGENCY: Federal Communications 

Commission. 

ACTION: Petitions for Reconsideration. 

SUMMARY: Petitions for Reconsideration 

(Petitions) have been filed in the 

Commission’s rulemaking proceeding 

by David A. LaFuria, on behalf of Smith 

Bagley, Inc., Russell D. Lukas, on behalf 

of Coalition of Rural Wireless Carriers, 

Carri Bennet, on behalf of Rural 

Wireless Association, Inc. and Jill 

Canfield, on behalf of NTCA-The Rural 

Broadband Association, Matthew B. 

Gerst, on behalf of CTIA and Maurita 

Coley, on behalf of Multicultural Media, 

Telecom and internet Council 

Convenors, 5G Fund Supporters. 

DATES: Oppositions to the Petitions 

must be filed on or before February 8, 

2021. Replies to an opposition must be 

filed on or before February 16, 2021. 

ADDRESSES: Federal Communications 

Commission, 45 L Street NE, 

Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Valerie M. Barrish, Auctions Division, 

Office of Economics and Analytics, 

(202) 418–0660 or Valerie.Barrish@

fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s 

document, Report No. 3165, released 

January 6, 2021. The full text of the 

Petitions can be accessed online via the 

Commission’s Electronic Comment 

Filing System at: http://apps.fcc.gov/ 

ecfs/. The Commission will not send a 

Congressional Review Act (CRA) 

submission to Congress or the 

Government Accountability Office 

pursuant to the CRA, 5 U.S.C. 

801(a)(1)(A), because no rules are being 

adopted by the Commission. 

Subject: Establishing a 5G Fund for 

Rural America, FCC 20–150, published 

at 85 FR 75770, November 25, 2020, in 

GN Docket No. 20–32. This document is 

being published pursuant to 47 CFR 

1.429(e). See also 47 CFR 1.4(b)(1) and 

1.429(f), (g). 

Number of Petitions Filed: 5. 

Federal Communications Commission. 

Marlene Dortch, 

Secretary, Office of the Secretary. 

[FR Doc. 2021–00464 Filed 1–21–21; 8:45 am] 

BILLING CODE 6712–01–P 


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