70516 Federal Register / Vol. 88, No. 195 / Wednesday, October 11, 2023 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 705 

[EPA–HQ–OPPT–2020–0549; FRL–7902–02– 

OCSPP] 

RIN 2070–AK67 

Toxic Substances Control Act 

Reporting and Recordkeeping 

Requirements for Perfluoroalkyl and 

Polyfluoroalkyl Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is finalizing reporting and 

recordkeeping requirements for per- and 

polyfluoroalkyl substances (PFAS) 

under the Toxic Substances Control Act 

(TSCA). In accordance with obligations 

under TSCA, as amended by the 

National Defense Authorization Act for 

Fiscal Year 2020, EPA is requiring 

persons that manufacture (including 

import) or have manufactured these 

chemical substances in any year since 

January 1, 2011, to submit information 

to EPA regarding PFAS uses, production 

volumes, byproducts, disposal, 

exposures, and existing information on 

environmental or health effects. In 

addition to fulfilling statutory 

obligations under TSCA, this rule will 

enable EPA to better characterize the 

sources and quantities of manufactured 

PFAS in the United States. 

DATES: This final rule is effective on 

November 13, 2023. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2020–0549, is 

available online at https://

www.regulations.gov. Additional 

instructions for visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Alie 

Muneer, Data Gathering and Analysis 

Division (7406M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–6369; 

email address: muneer.alie@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. Executive Summary 

A. Does this action apply to me? 

This action may apply to you if you 

have manufactured (defined by statute 

at 15 U.S.C. 2602(9) to include import) 

PFAS for a commercial purpose at any 

time since January 1, 2011. The 

following list of North American 

Industrial Classification System 

(NAICS) codes is not intended to be 

exhaustive, but rather provides a guide 

to help readers determine whether this 

document applies to them. Potentially 

affected entities may include: 

• Construction (NAICS code 23); 

• Manufacturing (NAICS code 31 

through 33); 

• Wholesale trade (NAICS code 42); 

• Retail trade (NAICS code 44 

through 45); and 

• Waste management and 

remediation services (NAICS code 562). 

This list details the types of entities 

that EPA is aware could potentially be 

regulated by this action. Other types of 

entities not listed could also be 

regulated. To determine whether your 

entity is regulated by this action, you 

should carefully examine the 

applicability criteria found in 40 CFR 

705.10 and 705.12. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed in the FOR FURTHER

INFORMATION CONTACT section. 

B. What is the Agency’s authority for 

taking this action? 

EPA is promulgating this rule 

pursuant to its authority in TSCA 

section 8(a)(7) (15 U.S.C. 2607(a)(7)). 

The National Defense Authorization Act 

for Fiscal Year 2020 (FY 2020 NDAA) 

(Pub. L. 116–92, section 7351) amended 

TSCA section 8(a) in December 2019, 

adding section 8(a)(7), titled ‘‘PFAS 

Data.’’ TSCA section 8(a)(7) requires 

EPA to promulgate a rule ‘‘requiring 

each person who has manufactured a 

chemical substance that is a [PFAS] in 

any year since January 1, 2011’’ to 

report information described in TSCA 

section 8(a)(2)(A) through (G). This 

includes a broad range of information, 

such as information related to chemical 

identity and structure, production, use, 

byproducts, exposure, disposal, and 

health and environmental effects. 

TSCA section 14 imposes 

requirements for the assertion, 

substantiation, and review of 

information that is claimed as 

confidential business information (CBI). 

C. What action is the Agency taking? 

In this action, EPA is promulgating 

reporting and recordkeeping 

requirements for entities who have 

manufactured (including imported) a 

PFAS for commercial purposes at any 

point since January 1, 2011. This rule 

takes into consideration comments 

received on the proposed rule (86 FR 

33926, June 28, 2021 (FRL–10017–78)) 

input from the Small Business 

Advocacy Review (SBAR) Panel that 

was convened following publication of 

the proposed rule, and comments 

received on the SBAR Panel Report and 

Initial Regulatory Flexibility Analysis 

(IRFA), which EPA published with a 

Notice of Data Availability (NODA) (Ref. 

1). Details on the final rule 

requirements, including modifications 

from the proposal, are explained in Unit 

III. 

EPA is finalizing this rule both to 

fulfill its obligations under TSCA 

section 8(a)(7), as amended by the FY 

2020 NDAA, and to create a more 

comprehensive database of previously 

manufactured PFAS to improve the 

Agency’s understanding of PFAS in 

commerce and to support actions to 

address PFAS exposure and 

contamination. 

D. Why is the Agency taking this action? 

TSCA section 8(a)(7) requires EPA to 

promulgate a rule requiring each person 

who has manufactured a PFAS in any 

year since January 1, 2011, to report 

certain information for each year since 

January 1, 2011. 

E. What are the incremental economic 

impacts? 

EPA has evaluated the costs and 

benefits of this rulemaking and 

provided an Economic Analysis of the 

potential impacts associated with this 

rule (Ref. 2). The primary benefit of this 

rule is providing EPA with data on 

PFAS which have been manufactured, 

including imported, for commercial 

purposes since 2011; the Agency is not 

currently aware of any similar source of 

information for these substances of 

interest. Subsequently, EPA will use 

these data to support activities 

addressing PFAS under TSCA, as well 

as activities and programs under other 

environmental statutes. The additional 

data on the production, use, exposure, 

and environmental and health effects of 

PFAS in the United States may allow 

EPA to more effectively determine 

whether additional risk assessment and 

management measures are needed. This 

information may lead to reduced costs 

of risk-based decision making and 

improved decisions concerning PFAS. 

EPA has evaluated the potential costs 

of this reporting and recordkeeping 

requirement for manufacturers and 

article importers. Since the notice of 

proposed rulemaking for this action 


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published on June 28, 2021 (86 FR 

33926 (FRL–10017–78)), EPA found 

additional data and received feedback 

via public comments to update its 

economic analysis, including estimating 

the number of PFAS article importers. 

EPA revised cost estimates from $10.8 

million in industry costs detailed in the 

draft Economic Analysis for the 

proposed rule to $876 million detailed 

in the IRFA and NODA (Ref. 1), to $843 

million using a 3 percent discount rate 

and $800 million using a 7 percent 

discount rate at the final rule stage. The 

final Economic Analysis (Ref. 2), which 

is available in the docket, is briefly 

summarized here. The regulated 

community is expected to incur onetime burdens and costs associated with 

rule familiarization, compliance 

determination, form completion, CBI 

claim substantiation, recordkeeping, 

and electronic reporting activities. 

Industry is estimated to incur a burden 

of approximately 11.6 million hours, 

with a cost of approximately $843 

million and $800 million under a 3 

percent and 7 percent discount rate, 

respectively. The Agency is expected to 

incur a cost of $1.6 million. The total 

social cost is therefore estimated to be 

approximately $844.8 million and 

$801.7 million under a 3 percent and 7 

percent discount rate, respectively. 

II. Background 

A. What are PFAS? 

PFAS are a group of synthetic 

chemicals that have been in use since 

the 1940s and can be found in a wide 

array of industrial and consumer 

products (Refs. 2 and 3). PFAS are 

synthesized for many different uses, 

ranging from firefighting foams to 

coatings for clothes and furniture, to 

food contact substances, to the 

manufacture of other chemicals and 

products. They are used in a wide 

variety of products, including textiles, 

electronics, wires and cables, pipes, 

cooking and bakeware, sport articles, 

automotive products, toys, 

transportation equipment, and musical 

instruments, which may be imported 

into the United States as finished 

articles (Ref. 2). PFAS can be released to 

the environment throughout the 

lifecycle of manufacturing, processing, 

distribution, use, and disposal (Refs. 3 

and 4). There is evidence that exposure 

to some PFAS in the environment may 

be linked to harmful health effects in 

humans and animals, and that 

continued exposure above specific 

levels to certain PFAS may lead to 

adverse health effects (Refs. 2, 3, and 4). 

B. What is TSCA section 8(a)(7)? 

On December 20, 2019, the National 

Defense Authorization Act for Fiscal 

Year 2020 (NDAA) was signed into law 

(Pub. L. 116–92). Among other 

provisions, section 7321 of NDAA 

added TSCA section 8(a)(7) which states 

that the Administrator shall promulgate 

a rule in accordance with this 

subsection requiring each person who 

has manufactured a chemical substance 

that is a perfluoroalkyl or 

polyfluoroalkyl substance (PFAS) in any 

year since January 1, 2011, to submit to 

the Administrator a report that includes, 

for each year since January 1, 2011, the 

information described in subparagraphs 

(A) through (G) of paragraph (2). The 

categories of information described in 

sections 8(a)(2)(A) through (G) are: 

• The common or trade name, 

chemical identity and molecular 

structure of each chemical substance or 

mixture for which a report is required; 

• Categories or proposed categories of 

use for each substance or mixture; 

• Total amount of each substance or 

mixture manufactured or processed, the 

amounts manufactured or processed for 

each category of use, and reasonable 

estimates of the respective proposed 

amounts; 

• Descriptions of byproducts 

resulting from the manufacture, 

processing, use, or disposal of each 

substance or mixture; 

• All existing information concerning 

the environmental and health effects of 

each substance or mixture; 

• The number of individuals exposed, 

and reasonable estimates on the number 

of individuals who will be exposed, to 

each substance or mixture in their 

places of work and the duration of their 

exposure; and 

• The manner or method of disposal 

of each substance or mixture, and any 

change in such manner or method. 

Finally, in carrying out TSCA section 

8, section 8(a)(5) requires EPA, to the 

extent feasible, to (A) not require 

unnecessary or duplicative reporting, 

(B) minimize compliance costs on small 

manufacturers and processors, and (C) 

apply any reporting obligations to those 

persons likely to have information 

relevant to effective implementation of 

TSCA. 

C. What did EPA propose? 

In the proposed rule, EPA published 

for the reporting and recordkeeping 

requirements for PFAS manufacturers 

under TSCA section 8(a)(7). EPA 

proposed to require any entity who had 

commercially manufactured a PFAS that 

is a TSCA chemical substance at any 

time since January 1, 2011, to 

electronically report certain information 

to EPA regarding PFAS identity, 

production volumes, industrial uses, 

commercial and consumer uses, 

byproducts, worker exposure, disposal, 

and any existing information related to 

environmental and health effects. Such 

information would be reported for each 

year since 2011 in which a covered 

PFAS was manufactured, to the extent 

such information were known to or 

reasonably ascertainable by the reporter. 

EPA also proposed a five-year 

recordkeeping period following the 

submission date. 

EPA also proposed the following 

structural definition of PFAS: per- and 

polyfluorinated substances that 

structurally contain the unit R-(CF2)– 

C(F)(R′)R′′. Both the CF2 and CF 

moieties are saturated carbons and none 

of the R groups (R, R′, or R′′) can be 

hydrogen. Under the proposal, reporting 

would have been required for any TSCA 

chemical substance (including any 

mixture with a chemical substance) 

which met the proposed structural 

definition and had been manufactured 

for a commercial purpose at any time 

since January 1, 2011. 

EPA did not propose any reporting 

exemptions or production volume 

thresholds. The scope of covered 

chemical substances under the proposed 

rule included any amounts of PFAS 

which were known to or reasonably 

ascertainable by the manufacturer, 

including PFAS-containing articles, 

byproducts, and impurities. EPA also 

did not propose any exemptions or 

flexibilities for small manufacturers. 

EPA proposed a six-month 

information collection period following 

the effective date of the final rule, after 

which the reporting tool would open for 

a six-month reporting period. Thus, the 

proposed rule stipulated a reporting 

deadline one year from the effective 

date of the final rule. 

III. Final PFAS Reporting and 

Recordkeeping Requirements 

In this unit, EPA discusses in detail 

the final reporting and recordkeeping 

requirements, including changes from 

the proposed rule in response to public 

input. 

A. What substances are covered by this 

rule? 

1. The Scope of PFAS for the Purpose 

of This Rule 

Under TSCA section 8(a)(7), EPA 

must collect information on chemical 

substances manufactured (including 

imported) for commercial purposes, 

including chemical substances present 

in a mixture, that are ‘‘perfluoroalkyl or 


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polyfluoroalkyl substances,’’ or PFAS. 

TSCA section 8(a)(7) does not define or 

characterize ‘‘PFAS.’’ EPA has 

determined that any TSCA chemical 

substance (as that term is defined by 

TSCA section 3(2); see Unit IV.A.2.) that 

falls within the structural definition at 

40 CFR 705.3 is subject to reporting 

under TSCA section 8(a)(7), if it has 

been manufactured for commercial 

purposes in any year since January 1, 

2011. The proposed definition defined 

PFAS as a substance that includes the 

following structure: R-(CF2)–C(F)(R′)R′′, 

in which both the CF2 and CF moieties 

are saturated carbons and none of the R 

groups (R, R′ or R′′) can be hydrogen. 

EPA found that at least 1,364 substances 

from both the TSCA Inventory 

(Inventory) and Low-Volume Exemption 

(LVE) claims would meet the proposed 

structural definition. Separately, a count 

of chemicals meeting the proposed 

definition on EPA’s CompTox 

Chemicals Dashboard (Ref. 6) found 

approximately 9,400 structures, though 

many of those structures are not known 

TSCA chemical substances and would 

be out of scope of reporting for this rule, 

as explained in section III.A.2 of this 

rule. 

EPA determined that a structural 

definition was more appropriate for this 

rule than a discrete list of specifically 

identified substances. Other TSCA 

requirements have relied on a structural 

definition when appropriate (e.g., the 

long-chain perfluoroalkyl carboxylate 

(LCPFAC) significant new use rule 

(SNUR) defines covered substances 

using a structural definition (40 CFR 

721.10536) (Ref. 7), and the polymer 

exemption rule for new chemical premanufacture notices (PMNs) defines 

covered PFAS polymers using structural 

definitions (40 CFR 723.250)). 

Additionally, other scientific and 

regulatory bodies, such as the 

Organization of Economic Cooperation 

and Development (OECD) (Refs. 8 and 

9), have defined PFAS using various 

structural definitions. Thus, there is 

clear precedent for using a structural 

definition both for TSCA rules and for 

actions addressing PFAS, and a 

structural definition is consistent with 

the text of TSCA section 8(a)(7). EPA 

also determined that limiting the scope 

of reporting to a discrete list of 

chemicals would eliminate reporting on 

substances of interest to the Agency. 

Given various reporting exemptions for 

both existing chemicals (e.g., certain 

byproducts and research and 

development (R&D) substances are 

exempt from reporting in the Chemical 

Data Reporting (CDR) rule) and new 

chemicals (e.g., byproducts and 

impurities that are not listed on the 

Inventory), and with minimum 

reporting thresholds under other rules, 

EPA may be unaware of some TSCA 

chemical substances which meet this 

structural definition of PFAS. Providing 

a discrete list based on substances 

currently on the Inventory and in LVEs 

likely limits EPA’s ability to capture all 

substances that meet the structural 

definition, and which may present 

properties similar to perfluorooctanoic 

acid (PFOA), perfluorooctane sulfonic 

acid (PFOS), and hexafluoropropylene 

oxide dimer acid (HFPO–DA) and its 

ammonium salt (popularly known as 

‘‘GenX’’). Therefore, EPA is defining 

PFAS for this TSCA section 8(a)(7) rule 

using a structural definition to avoid 

inadvertently limiting the scope of 

reporting to substances on a discrete 

list. 

After reviewing public comments, 

EPA determined that the proposed 

definition may not include all 

substances for which EPA believes 

reporting of information is necessary 

(see additional discussion of relevant 

public comment in Unit IV.A). 

Therefore, EPA is modifying the 

definition of PFAS from the proposal. 

For the purpose of this TSCA section 

8(a)(7) reporting rule, EPA is defining 

‘‘PFAS’’ using a structural definition. 

PFAS is defined as including at least 

one of these three structures: 

• R-(CF2)-CF(R′)R′′, where both the 

CF2 and CF moieties are saturated 

carbons; 

• R–CF2OCF2-R′, where R and R′ can 

either be F, O, or saturated carbons; and 

• CF3C(CF3)R′R′′, where R′ and R′′ can 

either be F or saturated carbons. 

Manufacturers of substances that do 

not meet this structural definition are 

not required to report under this rule. 

EPA is providing a list of substances 

that meet this definition, gathered from 

the Inventory, LVEs, and the CompTox 

Chemicals Dashboard; this list will be 

available in the CompTox Chemicals 

Dashboard at https://comptox.epa.gov/ 

dashboard. A substance that is not on 

this list but still falls under the 

definition of a ‘‘chemical substance’’ 

under TSCA (see Unit III.A.2) is subject 

to this rule if the substance has been 

manufactured for a commercial purpose 

since 2011. 

EPA is modifying the proposed 

definition first to remove the R group 

requirements, resulting in the first substructure of this rule’s definition of 

PFAS (i.e., R-(CF2)-CF(R′)R′′, where both 

the CF2 and CF moieties are saturated 

carbons). The removal of the R group 

requirements from the proposed 

definition will expand the universe of 

PFAS to include additional substances 

of potential concern because they are 

likely to be persistent. While the 

proposed definition was developed to 

focus on substances most likely to be 

persistent in the environment while 

excluding those substances that are 

‘‘lightly’’ fluorinated (i.e., the molecule 

only contains unconnected CF2 or CF3

moieties), EPA acknowledges that 

substances that are not fully fluorinated 

may still be persistent in the 

environment. This is because the 

persistence of organofluoro compounds 

is more related to the density of C–F 

bonds within the molecule than simply 

the existence of fully fluorinated 

carbons (Ref. 10). The final definition, 

which does not include the proposed 

definition’s R group requirements 

focuses the definition on those 

substances most likely to persist in the 

environment. The final definition does 

not include substances that only have a 

single fluorinated carbon, or 

unsaturated fluorinated moieties (e.g., 

fluorinated aromatic rings and olefins). 

The latter set of substances are more 

susceptible to chemical transformation 

than their saturated counterparts, and 

therefore, are less likely to persist in the 

environment (Ref. 10). EPA has 

determined that, for the purpose of this 

rule, it is unnecessary to extend 

reporting requirements to substances 

that only have a single fluorinated 

carbon or unsaturated fluorinated 

moieties and are therefore less likely to 

persist in the environment, unlike 

substances like PFOA, PFOS, and GenX. 

In addition to modifying the proposed 

definition by removing the R group 

requirements, EPA determined that the 

definition should be further expanded 

by adding two sub-structures that will 

include certain substances of interest to 

the Agency and to public commenters. 

Furthermore, the additional two substructures will encompass other 

chemical substances that are persistent 

in the environment but were not 

covered by the proposed definition. The 

second sub-structure (R–CF2OCF2-R′, 

where R and R′ can either be F, O, or 

saturated carbons) aims to capture 

certain fluorinated ethers. EPA believes 

that these ethers are likely to be found 

in water; for example, perfluoro-2- 

methoxyacetic acid (PFMOAA) 

(Chemical Abstracts Service Registry 

Number (CASRN) 674–13–5) and other 

chemicals with structures similar to 

GenX found in the Cape Fear River. 

However, they may not have been 

reported to the Inventory or as an LVE, 

and therefore would not have been 

considered when developing the 

proposed definition, which focused on 

substances in the known TSCA universe 


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(i.e., the Inventory and LVEs). 

Additionally, it is possible that such 

substances are not on the Inventory due 

to TSCA reporting exemptions (e.g., 

byproducts, or certain R&D substances). 

Based on these ethers’ properties and 

the lack of prior TSCA reporting, EPA 

believes that data related to the 

manufacturing of these PFAS is 

necessary to carry out TSCA section 

8(a)(7) and would not be duplicative of 

other reporting. Thus, EPA is interested 

in known or reasonably ascertainable 

information on substances meeting this 

sub-structure definition, as it meets 

EPA’s threshold of focusing on 

chemicals more likely to exhibit 

properties similar to GenX (along with 

PFOA and PFOS), including their likely 

presence in the environment. 

Finally, the third sub-structure 

(CF3C(CF3)R′R′′, where R′ and R′′ can 

either be F or saturated carbons) aims to 

capture a different type of branching for 

highly fluorinated substances that 

would not meet the proposed definition 

due to their non-adjacent fluorinated 

carbons. These substances are likely to 

be persistent, and EPA believes that 

reporting for these more branched 

substances is necessary to collect the 

information described in TSCA section 

8(a)(2)(A)–(G) for substances with 

similar persistence properties as PFOA, 

PFOS, or GenX. For instance, 4,4,4- 

Trifluoro-2,2,3,3- 

tetra)kis(trifluoromethyl)butanoic acid 

(CASRN 1882109–62–7) would not have 

met the proposed definition due to its 

non-adjacent fluorinated carbons, but it 

has the same number of carbon, 

fluorine, and oxygen atoms as PFOA, 

and has been identified as an isomer of 

PFOA under the Stockholm Convention 

(Ref. 11). Further, this substance, like 

other substances meeting this substructure, has many highly fluorinated 

moieties such that EPA believes it is 

likely to be persistent in the 

environment. EPA is interested in 

known or reasonably ascertainable 

information on substances meeting this 

sub-structure definition, as these 

chemicals are likely to persist in 

environments to which they are 

released. 

Under this rule’s definition of PFAS, 

EPA identified additional substances 

that may be subject to the rule from the 

Inventory and LVEs, i.e., ‘‘known TSCA 

chemical substances.’’ Specifically, EPA 

identified an additional 22 chemical 

substances on the Inventory and 19 

LVEs, all of which are now covered 

under the first sub-structure of this 

rule’s definition. To date, EPA has not 

identified any additional substances on 

the Inventory or as an LVE under the 

second and third sub-structures. This 

relatively modest increase of 41 known 

TSCA chemical substances would bring 

the known universe of TSCA chemical 

substances meeting this rule’s definition 

of PFAS to 1,462, from 1,364 known 

TSCA PFAS identified by the proposed 

definition. However, as discussed 

previously, a substance’s absence on the 

Inventory or LVEs may be due, at least 

in part, to several exemptions for 

Inventory and new chemicals reporting 

(e.g., byproducts, impurities, certain 

R&D substances). In the absence of those 

exemptions, a PFAS meeting the 

definition under TSCA section 3(2) may 

be subject to reporting under this rule. 

EPA is also affirming that 

fluoropolymers which meet this rule’s 

definition of PFAS are reportable under 

this rule; this includes higher molecular 

weight fluoropolymers. EPA does not 

believe the requested data on 

fluoropolymers would be considered 

duplicative or unnecessary: this 

information is not reported to EPA 

otherwise, and any manufacturers’ 

existing information on such 

fluoropolymers will inform EPA’s 

understanding of such types of PFAS 

within U.S. commerce, including their 

downstream uses and their disposal 

methods. 

EPA notes that this definition may not 

be identical to other definitions of PFAS 

used within EPA and/or by other 

organizations. The term ‘‘PFAS’’ has 

been used broadly by many 

organizations for their individual 

research and/or regulatory needs. 

Various programs or organizations have 

distinct needs or purposes apart from 

this TSCA section 8(a)(7) reporting rule, 

and therefore, different definitions of 

the term ‘‘PFAS’’ may be appropriate for 

other purposes. The Agency notes that 

this perspective, that different users 

may have very different needs and no 

single PFAS characterization or 

definition meets all needs, is shared by 

many other organizations, including 

OECD (see page 29, Ref. 8). EPA has 

determined the final definition of 

‘‘PFAS’’ is the most appropriate 

definition for this TSCA section 8(a)(7) 

rule and acknowledges that there may 

be other rules or programs who apply 

different definitions to meet their own 

needs. 

2. Definition of ‘‘Chemical Substance’’ 

Under TSCA and PFAS in Mixtures 

This rule is limited to manufacturers 

(including importers) of PFAS that are 

considered a ‘‘chemical substance.’’ 

Under TSCA section 3(2), ‘‘chemical 

substance’’ means any organic or 

inorganic substance of a particular 

molecular identity, including: (1) Any 

combination of such substances 

occurring in whole or in part as a result 

of a chemical reaction or occurring in 

nature, and (2) Any element or 

uncombined radical. This rule does not 

require reporting on activities that are 

excluded from the definition of 

‘‘chemical substance’’ in TSCA section 

3(2)(B). 

Even though the definition of 

chemical substance excludes mixtures, 

PFAS as a chemical substance may be 

present in a mixture. Therefore, this rule 

requires reporting on each chemical 

substance that is a PFAS, including as 

a component of a mixture. This rule 

does not require reporting on 

components of a mixture that do not fall 

under the structural definition of PFAS, 

as explained in Unit III.A.1. 

B. Which entities are covered by this 

rule? 

1. Scope of Covered Entities 

Anyone who has manufactured 

(including imported) a PFAS for a 

commercial purpose in any year since 

January 1, 2011, is covered by this rule. 

As noted in Unit III.B.2, ‘‘manufacture 

for a commercial purpose’’ includes the 

coincidental manufacture of PFAS as 

byproducts or impurities. EPA believes 

at least portions of the NAICS codes 

listed in Unit I.A. may be covered by 

this rule. This rule extends to 

manufacturers (including importers) 

only. Importers of PFAS in articles are 

considered PFAS manufacturers. 

Persons who have only processed, 

distributed in commerce, used, and/or 

disposed of PFAS are not required to 

report under this rule, unless they also 

have manufactured PFAS for a 

commercial purpose. If an entity (such 

as a wastewater treatment plant) is 

simply processing PFAS they received 

domestically, and not also 

manufacturing PFAS, including as a 

byproduct, then the entity is not 

covered by this rule. Although EPA 

received several public comments about 

extending the rule to cover processors 

(see Unit IV.), TSCA section 8(a)(7) only 

refers to manufacturers and expanding 

the rule to processors would be 

pursuant to EPA’s separate rulemaking 

authority at TSCA section 8(a)(1), which 

the Agency is not pursuing at this time. 

2. Scope of ‘‘Manufacture for 

Commercial Purposes’’ 

Pursuant to TSCA section 8(f), the 

scope of ‘‘manufacturing’’ for the 

purposes of this rule is limited to 

entities manufacturing for a commercial 

purpose. EPA is defining ‘‘manufacture 

for commercial purposes’’ to align with 

definitions used in other rules. 

Specifically, ‘‘manufacture for 


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commercial purposes’’ includes the 

import, production, or manufacturing of 

a chemical substance or mixture 

containing a chemical substance with 

the purpose of obtaining an immediate 

or eventual commercial advantage for 

the manufacturer. This includes, but is 

not limited to, the manufacture of 

chemical substances or mixtures for 

commercial distribution, including test 

marketing, or for use by the 

manufacturer itself as an intermediate or 

for product research and development. 

‘‘Manufacture for commercial purposes’’ 

also includes the coincidental 

manufacture of byproducts and 

impurities that are produced during the 

manufacture, processing, use, or 

disposal of another chemical substance 

or mixture. As described in Unit III.B.1, 

simply receiving PFAS from domestic 

suppliers or other domestic sources is 

not, in itself, considered manufacturing 

PFAS for commercial purposes. Entities 

that process and/or use PFAS only need 

to report on PFAS they have 

manufactured (including imported), if 

any. 

However, certain activities are not 

considered ‘‘manufacture for 

commercial purposes’’ under TSCA 

section 8(f) (e.g., non-commercial R&D 

activities such as scientific 

experimentation, research, or analysis 

conducted by academic, government, or 

independent not-for-profit research 

organizations, unless the activity is for 

eventual commercial purposes) and are 

not subject to the reporting 

requirements in this rule. For example, 

reporting would not be required for a 

Federal agency which manufactures or 

imports PFAS when it is not for any 

immediate or eventual commercial 

advantage. 

3. Non-Reportable Activities 

As discussed in Unit III.B.2, entities 

who have manufactured PFAS for a 

commercial purpose include those who 

have imported PFAS (including in 

wastes), or those who have 

coincidentally produced PFAS during 

the manufacture, processing, use, or 

disposal of another chemical substance 

or mixture. EPA noted in the proposed 

rule that this may include certain waste 

management companies, if they have 

imported PFAS in a waste or produced 

PFAS at their site during the disposal of 

another chemical substance or mixture. 

Through public comments and input 

during the SBAR Panel, EPA 

understands that entities engaged in 

certain waste management activities are 

in the unique position of not having 

knowledge of PFAS they may have 

manufactured for commercial purposes. 

Entities that import municipal solid 

wastes (MSW) for the purpose of 

disposal or destruction cannot know or 

reasonably ascertain that they imported 

PFAS in the MSW streams. MSW 

streams are heterogeneous and generally 

difficult to characterize, in the absence 

of notification or labeling requirements 

related to the content of the waste. 

There were no Federal labeling or 

notification requirements for PFAS in 

wastes concurrent with this reporting 

period, nor are there general labeling 

practices for PFAS in MSW streams that 

are sent for disposal or destruction. 

Additionally, standard analytical 

methods for PFAS in MSW streams 

were not available during this reporting 

period. Because no PFAS was listed as 

a hazardous waste and subject to 

notification requirements under the 

Resource Conservation and Recovery 

Act (RCRA) or other Federal laws during 

this rule’s lookback period (i.e., since 

January 1, 2011), and due to general 

industry practices, EPA understands 

that importers of MSW streams for 

disposal or destruction would not have 

any records or data that they had 

imported PFAS or any other information 

relevant to TSCA section 8(a)(7). 

Therefore, EPA has determined that 

waste management activities involving 

importing municipal solid waste 

streams for the purpose of disposal or 

destruction are not within scope of this 

rule’s reporting requirements, per EPA’s 

obligations under TSCA section 

8(a)(5)(C). 

However, EPA is not broadly 

exempting all waste management 

facilities from this rule. Facilities that 

have imported waste containing PFAS, 

other than in MSW streams for 

destruction or disposal, are likely to 

have information relevant to this rule. 

Other waste management sites may have 

relevant information regarding PFAS 

contents in waste they have imported 

outside of MSW, or for the purpose of 

recycle or reuse; thus, EPA is required 

to apply reporting requirements to such 

entities who may have relevant 

information, pursuant to TSCA section 

8(a)(5)(C). This would include waste 

management sites who import PFAScontaining waste (including in MSW) 

for the purpose of recycling or reuse for 

PFAS-containing products, as well as 

waste management sites who import 

PFAS in wastes that are not municipal 

solid waste streams. In the former 

activity, entities who import wastes that 

may contain PFAS, such as some 

carpets and rugs, for the purpose of 

recycling or reusing the PFAScontaining material, may be aware of the 

general nature of those materials and the 

downstream processing and use 

information that is responsive to this 

rule (see Table 14, Ref. 12). In the latter 

activity, importers of PFAS-containing 

wastes that are not MSW (such as 

industrial wastes) may also have 

knowledge of the contents of the waste 

they have imported due to labeling or 

notification practices, including under 

international agreements affecting 

transboundary movement of wastes (Ref. 

13). Because certain importers of waste 

(besides MSW that is imported for the 

purpose of disposal or destruction) are 

anticipated to know or reasonably 

ascertain that they have manufactured 

PFAS, EPA is extending reporting 

requirements to manufacturers 

(including importers) of PFAS in 

wastes, unless they have imported PFAS 

in municipal solid waste streams for the 

purpose of disposal or destruction. 

C. What is the reporting standard of this 

rule? 

For the purpose of this rule, the 

reporting standard is information 

known to or reasonably ascertainable by 

the manufacturer, which is the standard 

used in other TSCA section 8 rules, 

including CDR since 2011 (see TSCA 

section 8(a)(2)). ‘‘Known to or 

reasonably ascertainable by’’ is defined 

to include ‘‘all information in a person’s 

possession or control, plus all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know’’ (40 CFR 

704.3). This reporting standard requires 

reporting entities to evaluate their 

current level of knowledge of their 

manufactured products (including 

imports), as well as evaluate whether 

there is additional information that a 

reasonable person, similarly situated, 

would be expected to know, possess, or 

control. This standard carries with it an 

exercise of due diligence, and the 

information-gathering activities that 

may be necessary for manufacturers to 

achieve this reporting standard may 

vary from case-to-case. 

This standard would require that 

submitters conduct a reasonable inquiry 

within the full scope of their 

organization (not just the information 

known to managerial or supervisory 

employees). This standard may also 

entail inquiries outside the organization 

to fill gaps in the submitter’s 

knowledge. Such activities may, though 

not necessarily, include phone calls or 

email inquiries to upstream suppliers or 

downstream users or employees or other 

agents of the manufacturer, including 

persons involved in the research and 

development, import or production, or 

marketing of the PFAS. Examples of 

types of information that are considered 

to be in a manufacturer’s possession or 


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control, or that a reasonable person 

similarly situated might be expected to 

possess, control, or know include: files 

maintained by the manufacturer such as 

marketing studies, sales reports, or 

customer surveys; information 

contained in standard references 

showing use information or 

concentrations of chemical substances 

in mixtures, such as a Safety Data Sheet 

(SDS) or a supplier notification; and 

information from the CAS or from Dun 

& Bradstreet (D–U–N–S). However, if 

particular information cannot be 

derived or reasonably estimated without 

conducting further customer surveys 

(i.e., without sending a comprehensive 

set of identical questions to multiple 

customers), it would not be ‘‘reasonably 

ascertainable’’ to the submitter. Thus, 

there is not a need to conduct new 

surveys for purposes of this rule. As 

described previously, however, existing 

survey data may nevertheless be 

‘‘known to’’ the organization. This 

information may also include 

documented knowledge gained through 

discussions, conferences, and technical 

publications. In addition, this is the 

same reporting standard employed in 

the TSCA section 8(a) CDR rule (40 CFR 

711.15). In response to public comments 

and input received through the SBAR 

Panel, EPA has also created additional 

compliance guidance related to this 

reporting standard, including for small 

entities and for article importers (Ref. 

14). Therefore, EPA anticipates many 

reporters under this rule are familiar 

with this reporting standard, and 

resources are available to support those 

reporters who may not be familiar with 

the standard. 

In the event that a manufacturer 

(including importer) does not have 

actual data (e.g., measurements or 

monitoring data) to report to EPA, the 

manufacturer (including importer) 

should consider whether ‘‘reasonable 

estimates’’ of such information are 

ascertainable. ‘‘Reasonable estimates’’ 

may rely, for example, on approaches 

such as mass balance calculations, 

emissions factors, or best engineering 

judgment. EPA notes that many of the 

data elements requested under this rule, 

including production volumes or 

environmental release volumes, 

incorporate a level of estimation by 

requiring only two significant figures. 

Other data elements, including worker 

exposure, are reported as ranges, as with 

CDR. For instance, a manufacturer may 

be able to estimate the range of number 

of workers reasonably likely to be 

exposed for each commercial use based 

on the manufacturer’s knowledge of the 

commercial sites’ sizes, without specific 

workplace monitoring data; the 

manufacturer, would report the 

estimated range, rather than reporting 

that the information is not known. In 

general, EPA believes that industry 

possesses a greater knowledge than EPA 

about its own supply chain and 

operations related to the chemical 

substances it manufactures and the 

downstream uses, even if they do not 

control their customers’ sites. However, 

if manufacturers do not know nor can 

reasonably make estimates for certain 

data elements, except for production 

volumes, they may indicate such 

information is ‘‘Not Known or 

Reasonably Ascertainable’’ (NKRA) to 

them in lieu of the requested estimate or 

range. For instance, if a manufacturer 

does not know and cannot reasonably 

ascertain (including, having no basis for 

a reasonable estimate or assumption 

based on past experiences for the same 

or similar substances) how a PFAS is 

disposed of as a waste in a given year, 

the manufacturer may submit ‘‘NKRA’’ 

for that information. Reporters are also 

advised that ‘‘NKRA’’ designations 

cannot be claimed as CBI under TSCA 

section 14. Reporting NKRA should 

only happen when data are truly not 

reasonably ascertainable or are 

unattainable (e.g., when the appropriate 

recordkeeping period has lapsed and a 

past record is no longer available). 

EPA has published reporting 

instructions and a Small Entity 

Compliance Guide, which include 

information related to this reporting 

standard and the activities that small 

entities, including article importers, 

may take to meet the due diligence 

requirement (Ref. 14). 

If, after conducting due diligence and 

reviewing known or reasonably 

ascertainable existing information, a 

manufacturer, particularly an importer 

of articles containing PFAS, may not 

have knowledge that they have 

manufactured or imported PFAS and 

thus need not report under this rule. 

EPA encourages such an entity to 

document its activities to provide 

evidence of due diligence. Additionally, 

consistent with their own business 

practices, companies may elect to retain 

documentation of their conclusion that 

they were not subject to reporting 

requirements. 

D. What information must be reported 

under this rule? 

1. General Reporting Form 

EPA is requiring that PFAS 

manufacturers submit the following 

information for each PFAS, for each 

year in which that substance was 

manufactured since January 1, 2011, to 

the extent the information is known or 

reasonably ascertainable. For the 

purposes of this rule, EPA is requiring 

this information to be submitted for 

each chemical substance that is a PFAS. 

For mixtures that contain at least one 

chemical substance that is a PFAS, 

manufacturers must submit information 

for each chemical substance in the 

mixture that is a PFAS. For example, a 

mixture comprised of PFAS A and 

PFAS B would result in the submission 

of two forms containing the information 

described later in this unit for each 

PFAS. For chemical substances of 

unknown or variable compositions, 

complex reaction products, and 

biological materials (UVCBs), including 

polymers, a single form may be 

submitted for that UVCB. EPA 

encourages submitters of mixtures and 

UVCBs that contain PFAS to provide 

additional information in the optional 

free text box related to the composition 

of that mixture or UVCB at the time of 

manufacture, if known. 

EPA is largely finalizing the proposed 

reporting requirements, with a few 

modifications based on public 

comments. Changes to the proposed 

requirements include: removing the 

requirements for reporting maximum 

production volume in the first 12 

months and maximum yearly 

production volume in any 3 years; 

removing the requirement for reporting 

the maximum quantity on-site at any 

time (including storage); modifying the 

requirement to submit the molecular 

structure for each substance by making 

the submission optional for any Class 1 

chemical substance on the Inventory 

(but required for all others); requiring 

submitters to provide a generic name or 

description (which indicates, at least, 

that the substance is fluorinated) in lieu 

of the specific chemical identity or trade 

name when neither are known; 

reporting analytical methods, if any; 

adding optional comment boxes to 

provide any additional information or 

clarification to EPA. 

A spreadsheet containing the 

reporting requirements is also available 

in the docket (Ref. 15). 

2. Streamlined Reporting Form Option 

for Article Importers 

Article importers are not exempt from 

this rule. Given the reporting 

exemptions in other TSCA reporting 

rules, exempting imported articles from 

the scope of this TSCA section 8(a)(7) 

reporting rule would perpetuate data 

gaps in EPA’s level of knowledge related 

to PFAS manufactured for a commercial 

purpose since 2011. EPA cannot know 

what requested information is 

‘‘reasonably ascertainable’’ to all article 


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importers without knowing the full 

range of potentially available 

information to be reported. Thus, EPA 

does not otherwise have the information 

outlined in TSCA section 8(a)(7) on 

PFAS within imported articles, and the 

Agency cannot justify a broad 

exemption of imported articles under 

TSCA section 8(a)(5)(A), which requires 

EPA, to the extent feasible, to not 

require unnecessary or duplicative 

reporting. However, after considering 

public input on the information that 

may be known to or reasonably 

ascertainable by some PFAS article 

importers, EPA is finalizing a reporting 

option for article importers to provide 

data to EPA on a streamlined form, if 

they do not know or cannot reasonably 

ascertain information requested on the 

longer standard form described in Unit 

III.D.1. 

If an article importer determines they 

have imported a covered substance in 

an article, they would have the option 

to provide information to EPA through 

the streamlined form. The information 

requested through this streamlined form 

would still include chemical identity, 

processing and use information, and 

production volume, as well as the 

option to provide any additional 

information to EPA that the entity may 

have (e.g., SDS, disposal information). 

The production volume requested is 

the volume of the imported article, 

rather than the PFAS. EPA believes it is 

more likely that an article importer is 

able to determine the total imported 

production volume of articles rather 

than the volume related to just the PFAS 

contained within the article. For 

instance, an article importer may submit 

as the production volume the total 

weight of the PFAS-containing imported 

articles (e.g., in tons or pounds). 

Alternatively, the article importer could 

report the production volume in terms 

of quantity of the article imported (e.g., 

number of vehicles). The reporter would 

also be required to specify the unit of 

measurement reflected in the imported 

production volume. Based on 

information provided from article 

importers during the public comment 

period and the SBAR Panel, EPA 

believes that many article importers 

would have more difficulty providing 

precise production volumes of just the 

PFAS within an article. Industry input 

indicated that the historical 

documentation provided to article 

importers would not always or reliably 

include the weight or concentration of 

a PFAS contained in the article, making 

it more difficult for article importers to 

precisely calculate the production 

volume of just the PFAS contained 

within the article. Based on public input 

on the historical reporting practices and 

knowledge of PFAS in imported articles, 

and the fact that this rule is not a 

product testing requirement, EPA 

believes that article importers are more 

easily able to determine the imported 

production volume of the article itself. 

EPA acknowledges that it would be 

preferable to have the production 

volume of the chemical itself, though 

having the production volume of the 

imported article would still confer 

meaningful information to EPA for the 

purpose of chemical assessments under 

TSCA and other programs. Because EPA 

would rather have data on the 

production volume of the imported 

article, rather than many ‘‘NKRA’’ 

responses related to the production 

volume of the PFAS itself, EPA is 

requiring article importers to submit the 

production volume information on the 

whole article rather than the PFAS 

contained within the article. 

The streamlined article importer form 

would require the following information 

to the extent it is known or reasonably 

ascertainable: 

1. Chemical identity: 

a. Specific chemical name, or 

b. Generic name(s) or description(s) if 

the specific chemical name(s) is claimed 

as CBI and/or when a manufacturer 

knows they have a PFAS but is unaware 

of its specific chemical identity. A 

generic name must meet the naming 

requirements for this rule and indicate 

the substance is a fluorinated substance 

(i.e., contain ‘‘fluor’’). 

2. Chemical identification number: 

a. CASRN, or 

b. Accession or LVE case number, if 

applicable, and if the specific CASRN is 

unknown. EPA notes that this rule does 

not require manufacturers to obtain a 

CASRN or other identifier for a 

substance without such a number for 

the purpose of complying with this rule. 

3. Trade name or common name, if 

applicable. 

4. Representative molecular structure, 

for any PFAS that is not a Class 1 

substance on the Inventory. And 

optional free text for further clarification 

on the chemical identity or molecular 

structure (such as for Class 2 substances, 

or where the molecular structure is of 

unknown or variable composition). 

5. Import production volume of the 

imported article and the unit of 

measurement for that production 

volume (e.g., quantity of the imported 

article, pounds, tons). 

6. Industrial processing and use: 

a. Type of process or use; 

b. Sector(s); 

c. Functional use category(ies); and 

d. Percent of production volume for 

each use. 

7. Consumer and commercial use: 

a. indicator for whether this is a 

consumer and/or commercial product; 

b. Product category; 

c. Functional use category(ies); 

d. Percent production volume for each 

use; 

e. Maximum concentration in any 

product; 

f. Indicator for use in products 

intended for children; 

g. Indicator for imported but never 

physically at site; and 

h. Any optional information the 

article importer wishes to provide. 

Under TSCA section 8(a)(5)(C), EPA 

must, to the extent feasible, ‘‘apply any 

reporting obligations to those persons 

likely to have information relevant to 

the effective implementation of 

[TSCA].’’ EPA believes that this 

streamlined reporting form option for 

any article importer would still provide 

necessary information to EPA under 

TSCA section 8(a)(7), while reducing 

the reporting burden for the data 

elements that EPA understands may not 

be known to or reasonably ascertainable 

by article importers. However, to the 

extent any additional information 

requested on the longer forms is known 

to or reasonably ascertainable by the 

article importer (e.g., information on 

disposal of that PFAS, or an SDS or 

other existing information regarding 

environmental or health effects), the 

reporter would have the option and 

ability to submit that information to 

EPA through the ‘‘optional’’ field. EPA 

also notes that it is possible that a 

manufacturer both imports a PFAS 

within an article, and otherwise 

manufactures (including imports) the 

same PFAS beyond an article. In such 

scenarios, the reporter would still have 

to provide information on the longer 

standard form for the non-imported 

article and would have the option to 

report on the PFAS within the imported 

article either on the streamlined form or 

within the longer standard form. The 

reporting tool for this rule will enable 

multiple form options for the same 

PFAS if appropriate. 

3. Streamlined Reporting Form Option 

for R&D Substances Manufactured 

Below 10 Kilograms 

EPA is also including R&D substances 

that were manufactured, including 

imported, for a commercial purpose 

within the scope of this rule. EPA notes 

that the scope of ‘‘manufacture for 

commercial purposes’’ encompasses any 

importing, production, or other 

manufacturing activities with the 

purpose of obtaining an immediate or 

eventual commercial advantage and 

includes chemicals ‘‘for use by the 


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manufacturer, including use for product 

research and development’’ (40 CFR 

704.3). R&D substances which meet the 

scope of ‘‘manufacture for commercial 

purposes’’ must be reported under this 

rule, even if the PFAS itself was not 

later commercialized. However, R&D 

substances which have not been 

manufactured for commercial purposes 

(such as for scientific experimentation, 

research, or analysis conducted by 

academic, government, or independent 

not-for-profit research institutions, 

unless the activity is for eventual 

commercial purposes) would not be 

within scope of this rule (40 CFR 

720.30(i)). 

EPA believes that the submission of 

information related to the commercial 

manufacture of PFAS as R&D substances 

is necessary to understand the scope of 

PFAS manufactured in the United 

States. With existing R&D reporting 

exemptions under other TSCA rules 

(including CDR and PMN submissions), 

EPA does not have a dataset of PFAS 

manufactured as R&D substances. 

Therefore, reporting on such substances 

is necessary to the effective 

implementation of TSCA. Further, EPA 

understands that manufacturers of R&D 

substances that have been exempt under 

other reporting rules should have 

certain documentation available to 

support those exemption claims, in 

accordance with their recordkeeping 

requirements. 

However, EPA understands through 

input from public commenters and the 

SBAR Panel that much of the 

information requested for this rule is 

unknown and not reasonably 

ascertainable to manufacturers of R&D 

substances, particularly small entities 

who may manufacture R&D substances 

in small quantities. EPA believes that 

manufacturers of R&D substances in 

such low quantities are likely to have 

manufactured those substances purely 

for laboratory analytical purposes, 

which may be at their own site or their 

customers’ sites. As such, these 

manufacturers are aware of the R&D 

chemical identity and production 

volume but are unlikely to have any 

other information requested. However, 

EPA believes that manufacturers of R&D 

chemicals manufactured in larger 

quantities (i.e., greater than 10 

kilograms per year) are more likely to 

have the other information requested, 

including worker exposure information, 

disposal information, and health or 

environmental effects information (such 

as monitoring or toxicity data). Given 

EPA’s understanding of typical 

recordkeeping practices of R&D 

activities, it is likely that a manufacturer 

with greater quantities of R&D 

substances would know the requested 

information on those substances beyond 

their identities and production volumes. 

Under TSCA section 8(a)(5)(C), EPA 

shall, to the extent feasible, apply 

reporting requirements to those persons 

likely to have relevant information. 

Therefore, EPA is providing another 

streamlined reporting option to 

manufacturers of R&D substances that 

were manufactured in volumes under 10 

kilograms per year, if they do not know 

or cannot reasonably ascertain 

information requested on the longer 

standard form described in Unit III.D.1. 

Information requested on this form, 

for each R&D PFAS manufactured below 

10 kilograms per year, will include the 

following to the extent it is known or 

reasonably ascertainable: 

1. Chemical identity: 

a. Specific chemical name, or 

b. Generic name(s) or description(s) if 

the chemical name(s) is claimed as CBI 

and/or when a manufacturer knows they 

have a PFAS but is unaware of its 

specific chemical identity. A generic 

name must meet the naming 

requirements for this rule and indicate 

the substance is a fluorinated substance 

(i.e., contain ‘‘fluor’’). 

2. Chemical identification number: 

a. CASRN, or 

b. TSCA Accession Number or LVE 

case number, if applicable, and if the 

specific CASRN is unknown. EPA notes 

that this rule does not require 

manufacturers to obtain a CASRN or 

other identifier for a substance without 

such a number for the purpose of 

complying with this rule. 

3. Trade name or common name, if 

applicable. 

4. Representative molecular structure, 

for any PFAS that is not a Class 1 

substance on the Inventory. With 

optional free text for further clarification 

on the chemical identity or molecular 

structure (such as for Class 2 substances, 

or where the molecular structure is of 

unknown or variable composition). 

5. Production volume: 

a. Domestically manufactured. 

b. Imported. 

6. Indicator for imported but never 

physically at site. 

7. Any optional information the 

manufacturer wishes to provide. 

EPA believes that this streamlined 

reporting form option for any 

manufacturer of R&D substances in low 

volumes (i.e., below 10 kilograms per 

year) would still provide necessary 

information to EPA under TSCA section 

8(a)(7), while minimizing the cost of 

compliance for certain small 

manufacturers, consistent with TSCA 

section 8(a)(5), for the data elements 

that EPA understands may not be 

known to or reasonably ascertainable by 

such manufacturers. However, to the 

extent any additional information 

requested on the longer forms is known 

to or reasonably ascertainable by the 

manufacturer (e.g., information on 

disposal of that PFAS, or existing 

information regarding environmental or 

health effects), the manufacturer would 

be required to submit that information 

to EPA through the ‘‘optional’’ field on 

the streamlined reporting form. 

E. What must be submitted as ‘‘all 

existing information concerning the 

environmental and health effects’’ of a 

chemical substance? 

Pursuant to TSCA section 8(a)(2)(E), 

EPA is requiring the submission of ‘‘all 

existing information concerning the 

environmental and health effects’’ of the 

chemical substances covered by this 

rule. ‘‘All existing information 

concerning environmental and health 

effects’’ is defined as ‘‘any information 

of any effect of a chemical substance or 

mixture on health or the environment or 

both’’ (to be codified at 40 CFR 705.3) 

and is intended to be interpreted 

broadly. The scope of ‘‘all existing 

information concerning environmental 

and health effects’’ includes all health 

and safety studies but is not limited to 

formal studies. Chemical identity is 

always part of a health and safety study, 

and TSCA section 14(b) limits the extent 

to which health and safety studies and 

information from studies may be 

withheld from the public as confidential 

business information (CBI). Any 

information that bears on the effects of 

a PFAS on human health or the 

environment would be included, 

including information on the chemical 

substance developed or generated prior 

to the year 2011. The codified definition 

of ‘‘all existing information concerning 

environmental and health effects’’ at 40 

CFR 705.3 provides non-exhaustive 

examples, such as: 

• Toxicity information (e.g., long- and 

short-term tests of mutagenicity, 

carcinogenicity, teratogenicity; 

pharmacological effects; acute, 

subchronic, and chronic effects); 

• Ecological or other environmental 

effects on fish, invertebrates, or other 

animals and plants, such as 

bioconcentration or bioaccumulation 

tests; 

• Human and environmental 

exposure assessments, including 

workplace exposure, and the impacts of 

a chemical substance or mixture on the 

environment; and 

• Other data relevant to 

environmental and health effects 

including monitoring data to measure 

the exposure of humans or the 


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environment or a chemical substance, 

range-finding studies, preliminary 

studies, adverse effects reports, and any 

information, including medical 

screening or surveillance, such as under 

the American Conference of 

Government Industrial Hygienists 

(ACGIH). 

Following public comments, EPA is 

also clarifying that the scope of ‘‘all 

existing information concerning 

environmental and health effects’’ is 

information in the submitter’s 

possession or control. For the purpose 

of requiring existing information related 

to health or environmental effects, EPA 

is adopting the same definition of 

‘‘possession or control’’ as in the TSCA 

Pre-Manufacture Notice (PMN) 

regulations (40 CFR 720.3(y)). Thus, a 

PFAS manufacturer would not 

necessarily be searching all information 

in the public realm but would be 

submitting information in their 

possession or control, or other 

information for which they are 

responsible. This includes any data or 

other information in files maintained by 

the submitter’s employees, or the 

employees of a submitter’s subsidiary or 

partnership which is associated with 

research and development, test 

marketing or commercial marketing of 

the PFAS, regardless of the publication 

status. EPA is not requiring 

manufacturers to search open scientific 

literature to find relevant information 

on a PFAS that was previously not in 

their possession or control for the 

purpose of this rule. EPA believes that 

implementing such a requirement may 

result in duplicative information, if 

multiple PFAS manufacturers are 

submitting the same studies or other 

information that are available publicly 

(including in EPA’s scientific literature 

databases). 

EPA considered ways to avoid 

requiring the submission of potentially 

duplicative information concerning 

health and environmental effects (see 

TSCA section 8(a)(5)(A)), while still 

fulfilling EPA’s obligation under TSCA 

section 8(a)(7) to require reporting of 

such information. Such information 

concerning environmental or health 

effects may have been submitted to EPA 

previously under either TSCA section 

8(d) rules (as unpublished health and 

safety information) or TSCA section 8(e) 

(as a substantial risk notice). If a 

reporter has already submitted 

information concerning environmental 

or health effects to EPA under specific 

TSCA submissions, they need not resubmit that information if they provide 

the details of to which program (or 

under which rule) that information was 

submitted and in which year (e.g., TSCA 

section 8(e), in 2010). In the event of a 

reporter having previously submitted 

relevant environmental and health 

effects information, the reporter must 

ensure that the previous submission 

included all existing underlying 

information, including test data. Note 

that a previous submission of 

information concerning environmental 

or health effects does not relieve a 

manufacturer of providing all existing 

information concerning environmental 

or health effects that has not previously 

been submitted to EPA. See Unit III.F 

for more discussion on how EPA is 

mitigating potentially duplicative 

reporting for this rule. 

For environmental and health effects 

information that was previously 

submitted to EPA as CBI, the reporter 

would need to resubmit if that 

information predated the 2016 

Lautenberg Act amending TSCA and its 

CBI submission requirements and 

reassert the CBI claim (see §§ 705.22(f) 

and 705.30). If a reporter has submitted 

environmental and health effects 

information as CBI since the 2016 

Lautenberg Amendments to TSCA were 

implemented, then the manufacturer 

must provide EPA with details 

regarding when, how, and under which 

title and/or statutory authority the CBI 

claim was submitted, and the TSCA 

section 14 certification. In order for a 

reporter to earn an exemption from 

resubmitting that environmental and 

health effects information and reasserting a CBI claim, the reporter must 

be able to point to a previous claim that 

adequately covers the current claim. In 

any event of a reporter having 

previously submitted environmental or 

health effects information as CBI, 

whether pre- or post-Lautenberg 

Amendments, they must adequately 

substantiate their CBI claim. EPA 

encourages all reporters who have 

previously submitted environmental or 

health effects information as CBI to 

carefully review their previous 

submissions and determine whether the 

previous claims satisfy current CBI 

substantiation requirements, and to 

assert a new claim and substantiate if 

appropriate. More discussion on 

submitting CBI under this rule is in Unit 

III.G. 

Additionally, EPA is finalizing the 

requirement to submit all existing 

information concerning health and 

environmental effects in the format of 

OECD-harmonized templates, where 

such templates exist for the type of data 

(to be codified at 40 CFR 705.15(f)). 

OECD templates are accessible to the 

public online at https://oecd.org/ehs/ 

templates/harmonised-templates.htm 

(Ref. 16). This can be accomplished by 

using the freely available IUCLID6 

software by exporting the dossier in the 

OECD Harmonized Template working 

context. At the time of this rule 

publication, EPA can accept any 

dossiers generated using any version of 

IUCLID6. Users should refer to EPA web 

pages (to be identified) for updates on 

which version of IUCLID files will be 

accepted. 

A standardized format such as the 

OECD templates will improve the 

efficiency of review and organization of 

the submitted data. EPA believes that 

some of the data will already be 

available as an OECD template if the 

company had already submitted the 

studies under the European Union’s 

Registration, Evaluation, Authorization 

and Restriction of Chemicals (REACH) 

regulation (Ref. 16). In addition to the 

required template format, those subject 

to this rulemaking must submit any 

associated full study reports or 

underlying data as support documents. 

The full study reports and support 

documents are necessary for EPA to 

understand the full context and evaluate 

the quality of the data, which is 

necessary for the Agency to review to 

determine whether such data may be 

used for any future Agency actions. 

If an OECD-harmonized template is 

not available for a particular endpoint 

for which the manufacturer has relevant 

information, then the manufacturer 

must still submit the data. Such 

information may include, but is not 

limited to, raw monitoring data 

(regardless of having been aggregated or 

analyzed) of human or environmental 

exposure assessments and toxicity tests 

for either human health effects or 

ecological other environmental effects. 

F. What steps is the Agency taking to 

reduce potentially ‘‘duplicative’’ 

reporting? Does information need to be 

reported on the basis that it has already 

been reported to the Agency? 

TSCA section 8(a)(5)(A) requires EPA, 

to the extent feasible when carrying out 

TSCA section 8, to avoid requiring 

unnecessary or duplicative reporting. 

The Agency seeks to avoid collecting 

data on PFAS that would duplicate 

information already reported to the 

Agency, while ensuring EPA obtains all 

data required to be collected under 

TSCA section 8(a)(7) and that such data 

are submitted in a format that is 

conducive to the collection and review 

of a manufactured PFAS dataset. While 

developing this rule, EPA reviewed the 

data elements submitted under the CDR 

Rule to evaluate whether there may be 

some overlap with the information 

requested under this rule. Through 

internal review, and from input received 


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during the public comment periods and 

the SBAR Panel, the Agency has 

identified the following data elements 

that may have some overlap with CDR 

requirements: 

• Physical state of the chemical or 

mixture; 

• Production volume (domestically 

manufactured); 

• Production volume (imported); 

• Volume directly exported; 

• Indicator for imported but never 

physically at site; 

• Industrial processing and use type, 

sector(s), functional category(ies), and 

percent of production volume for each 

use; 

• Consumer and/or commercial 

indicator, product category(ies), 

functional category(ies), percent of 

production volume for each use, 

indicator for use in products intended 

for children, and maximum 

concentration in the product; and 

• Number of workers reasonably 

likely to be exposed for each 

combination of industrial processing or 

use operation, sector, and function, and 

the number of commercial workers 

reasonably likely to be exposed if the 

PFAS is contained in a commercial 

product. 

However, EPA notes that even though 

there are some potentially overlapping 

data elements between this rule and 

CDR, any duplication of reporting 

requirements is likely to be narrower in 

scope. For instance, CDR is limited to 

chemical substances on the Inventory. 

In contrast, the reporting requirements 

in this rule extend beyond chemicals on 

the Inventory and may cover chemicals 

subject to LVEs, byproducts, and other 

chemicals that may not have been 

reported on or added to the Inventory. 

In addition, CDR has a reporting 

threshold of 25,000 pounds (or 2,500 

pounds for chemicals subject to certain 

TSCA actions), along with several 

reporting exemptions, including for 

imported articles, certain byproducts, 

non-isolated intermediates, and small 

quantities of R&D substances, while this 

reporting rule does not incorporate any 

such thresholds or exemptions. Finally, 

while this rule requests the same data to 

be submitted for each year in which a 

PFAS has been manufactured since 

2011, CDR requires different 

information to be submitted in different 

years: for instance, reporters submit the 

total annual domestically manufactured 

production volume and the total annual 

imported volume separately only for the 

principal reporting year (e.g., 2019 for 

the 2020 reporting cycle), but only the 

combined total annual production 

volume is required reporting for the 

intervening years. Additionally, the 

CDR rule has been amended over the 

course of this reporting period, meaning 

certain data elements were not 

requested or submitted for all CDR 

cycles overlapping this rule’s lookback 

period. Specifically, the CDR industrial 

processing and use codes and 

consumer/commercial processing and 

use codes did not align with the OECDharmonized use codes until the 2020 

reporting cycle. While CDR submitters 

may have provided certain processing 

and use information related to PFAS 

they manufactured during previous CDR 

cycles, any CDR responses that do not 

sufficiently respond to this data call by 

providing the required OECD codes 

would not be duplicative of the 

information being reported under this 

rule. Therefore, while some data 

elements of this rule may be considered 

duplicative of CDR requirements, 

differences between CDR and this rule’s 

requirements (including reporting 

thresholds and reporting exemptions) 

may limit the scope of what is 

duplicative and duplicative information 

does not need to be re-reported for this 

rule. If the previous submission for the 

same data element under a different 

reporting rule was not accurate for 

purposes of this rule (e.g., by not 

reporting volumes related to an activity 

exemption that does not apply to this 

rule, or by reporting industrial 

processing and use information that 

does not align with the OECDharmonized use codes required under 

this rule), then the submitter must 

report the accurate information and 

cannot rely on their prior submission to 

satisfy this rule’s requirements. 

Beyond the CDR rule, some 

commenters and participants in the 

SBAR Panel suggested that other 

information requested under this rule 

may have been reported to EPA through 

a TSCA section 8(d) rule. Under TSCA 

section 8(d), EPA has the authority to 

request unpublished health and safety 

data studies, or lists of such studies, 

known to or reasonably ascertainable by 

manufacturers, processors, and 

distributors of certain chemical 

substances or mixtures. Commenters 

suggested that some ‘‘existing 

environmental and health effects 

information’’ on PFAS may have already 

been submitted to EPA through a TSCA 

section 8(d) rule and would be 

duplicative of information requested 

under this rule. 

While EPA agrees that any previous 

submissions of unpublished studies 

under TSCA section 8(d) need not be 

resubmitted under this TSCA section 

8(a)(7) rule, EPA does not anticipate that 

there will be much overlap between 

information requested under this rule 

and information that may have already 

been submitted through the reporting 

requirements related to the TSCA 

section 8(d) rule codified in 40 CFR part 

716. First, only a few substances already 

listed in a section 8(d) rule would meet 

this rule’s definition of PFAS; out of the 

many examples of PFAS, only oxirane, 

2-(2,2,3,3,4,4,5,5,6,6,7,7,7- 

tridecafluoroheptyl)- (CASRN 38565– 

52–5), hexane, 1,1,1,2,2,3,3,4,4,5,5,6,6,6- 

tetradecafluoro- (CASRN 355–42–0), 

and 1-butanamine, 1,1,2,2,3,3,4,4,4- 

nonafluoro-N,N-bis(1,1,2,2,3,3,4,4,4- 

nonafluorobutyl)- (CASRN 311–89–7) 

are listed as PFAS, which can be found 

in 40 CFR 716. Secondly, the substances 

which are listed in 40 CFR part 716 

have sunset dates, or reporting 

deadlines. The PFAS that have 

previously been listed in a section 8(d) 

rule have sunset dates between 1988 

and 1995; therefore, potentially 

duplicative section 8(d) reporting stops 

decades short of the scope of reporting 

for this rule (40 CFR 716) (53 FR 38645, 

September 30, 1988 (FRL–3439–9)). 

Finally, the scope of ‘‘unpublished 

health and safety studies’’ requested 

under a TSCA section 8(d) rule may not 

be as inclusive as the scope of ‘‘all 

existing information concerning the 

environmental and health effects’’ 

requested for the substances under this 

TSCA section 8(a)(7) rule. This rule’s 

scope of all existing information 

concerning environmental and health 

effects is intended to be broadly 

interpreted and is inclusive of any 

health and safety study, regardless of 

the date the information was collected 

or generated; see the discussion in Unit 

III.E. 

Similarly, ‘‘all existing information 

concerning the environmental and 

health effects’’ of a PFAS may include 

previous submissions to EPA pursuant 

to TSCA section 8(e). TSCA section 8(e) 

requires manufacturers, processors, and 

distributors of chemicals to notify EPA 

immediately of information that 

reasonably supports the conclusion that 

their substances or mixtures present a 

substantial risk of injury to health or the 

environment. To the extent that a 

substantial risk notification under TSCA 

section 8(e) may be duplicative with 

this rule’s requirements, the reporter 

need not resubmit such information, but 

will be required to indicate when they 

had previously provided that 

notification under TSCA section 8(e) so 

that EPA is able to locate that previous 

submission and satisfy the requirements 

of TSCA section 8(a)(7). Manufacturers 

who have previously submitted 

information to EPA under TSCA section 

8(d) or TSCA section 8(e) that may be 


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considered ‘‘existing information 

concerning the environmental and 

health effects’’ of a PFAS for which they 

are reporting under this TSCA section 

8(a)(7) rule need not resubmit the 

duplicative information. However, the 

manufacturer must indicate in the 

reporting form the year in which they 

had previously provided that 

information and under which rule (e.g., 

TSCA section 8(d), section 8(e)). If EPA 

has previously collected information 

relevant to the implementation of TSCA 

section 8(a)(7) and is able to locate that 

information based on the reporter’s 

submission, then EPA would be able to 

meet the information collection 

obligations under TSCA section 8(a)(7) 

without requiring potentially 

duplicative reporting. 

EPA also considered other, non-TSCA 

reporting rules’ potential overlap with 

this rule. These include the Toxics 

Release Inventory (TRI) and the 

Greenhouse Gas Reporting Program 

(GHGRP). Under the TRI, certain 

industrial and Federal facilities are 

required to report their annual releases 

and other waste management quantities 

and activities for TRI-listed toxic 

chemicals that are manufactured, 

processed, or otherwise used above the 

respective threshold. Information 

reported to TRI that is also requested 

under this rule includes: 

• Total volume recycled on-site; 

• Description of disposal process(es); 

• Total volume released to land; 

• Total volume released to water; 

• Total volume released to air; and 

• Total volume incinerated on-site. 

However, in the same vein as the 

limitations on potentially duplicative 

reporting with CDR and TSCA section 

8(d) rules, EPA does not anticipate 

much, if any, overlap in reporting 

between this rule and TRI. First, PFAS 

were not on the TRI chemical list until 

the FY 2020 NDAA automatically added 

172 PFAS effective calendar year 2020, 

with additional PFAS added annually 

since 2020 (Ref. 17). Therefore, the only 

potentially overlapping reporting of 

PFAS releases and other waste 

management quantities would be since 

2020, instead of the entire lookback 

period of this rule. Additional 

limitations in the potential overlap 

between this rule and TRI include the 

PFAS reporting threshold for TRI of 100 

pounds manufactured, processed, or 

otherwise used and certain TRI 

reporting exemptions for quantities 

below de minimis concentrations and in 

articles. Without a reporting threshold 

or similar reporting exemptions 

applicable for this rule, there may be 

more PFAS releases and other waste 

management activities reportable for 

this rule than for TRI. 

EPA also considered potential 

overlaps with GHGRP. The GHGRP 

requires annual reporting of greenhouse 

gas (GHG) data and other information 

from large GHG emissions sources (i.e., 

those that emit at least 25,000 tons of 

CO2-equivalent, any electricity 

generation site, aluminum, ammonia or 

cement production facility, and some 

municipal solid waste landfills), fuel 

and industrial gas suppliers, and carbon 

dioxide injection sites (Ref. 18) (40 CFR 

part 98). 111 compounds covered as 

GHGs and heat transfer fluids (HTF) 

would also be considered PFAS under 

this rule. Between this rule and the 

GHGRP, the following data elements 

may be duplicative for at least some 

GHGRP reporters: 

• Production volume (imported); 

• Volume directly exported; and 

• Total volume incinerated on-site. 

Besides the limited number of PFAS 

covered by GHGRP, other limitations on 

the potential overlap between this rule 

and GHGRP include the exemption of 

GHGRP reporting for quantities 

imported or exported below 25 

kilograms. Additionally, not all 

coincidentally manufactured chemicals 

(such as byproducts) are covered by 

GHGRP, though they fall under the 

definition of ‘‘manufacture for a 

commercial purpose’’ under this rule 

(40 CFR 705.3). Overall, there is a 

significant difference between the 

reporting requirements in the GHGRP 

and this rule, though EPA is allowing 

reporters to abstain from re-reporting 

any of the information listed previously 

in this unit for a PFAS that was 

previously reported to GHGRP, unless 

the GHGRP submission did not account 

for all quantities that are covered by this 

rule. 

EPA also notes the potential for 

duplicative reporting of environmental 

releases of certain byproducts within 

this rule. Pursuant to TSCA section 

8(a)(2)(D), EPA is requiring PFAS 

manufacturers to provide a ‘‘description 

of the byproducts resulting from the 

manufacture, processing, use, or 

disposal of each [PFAS].’’ However, 

EPA notes there may be occasions 

where a byproduct that resulted from 

the manufacture, processing, use, or 

disposal of a reported PFAS also meets 

this rule’s definition of PFAS. Because 

‘‘manufacture for commercial purposes’’ 

includes the coincidental manufacture 

of byproducts, that byproduct would 

also need to be reported under this rule 

to the extent data are known or 

reasonably ascertainable. As a 

reportable PFAS, information on that 

byproduct’s environmental releases 

would be requested twice, both as a 

byproduct of the originally 

manufactured PFAS and as a 

commercially manufactured PFAS itself. 

To mitigate potentially duplicative 

reporting concerns in such situations, 

manufacturers of byproducts that are 

also reportable PFAS under this rule 

need not re-report the environmental 

release information of that byproduct on 

the original PFAS’s form. 

To address potentially duplicative 

reporting, EPA is identifying specific 

types of information that need not be 

reported if the reporting entity indicates 

in the reporting tool that they have 

previously provided such information to 

EPA and provides information sufficient 

to allow the agency to locate that 

information. Pursuant to TSCA section 

8(a)(5)(A), EPA is limiting the 

requirement for reporting ‘‘duplicative’’ 

information if a PFAS manufacturer has 

previously submitted the requested 

information to EPA for that same PFAS 

in that same year through CDR, TRI, 

GHGRP, or TSCA sections 8(d) and 8(e), 

or is also reporting a PFAS byproduct 

on its own reporting form. Only the 

aforementioned data elements from 

CDR, TRI, and GHGRP; studies 

submitted under TSCA section 8(d) or 

8(e); and certain byproduct release 

information may be exempt from rereporting under this rule as potentially 

duplicative information. In these cases, 

the manufacturer would be required to 

indicate to which program (and in 

which year) that information was 

submitted (e.g., CDR, in 2016). 

Additionally, EPA notes that a 

manufacturer’s previous submission for 

the same data element under a different 

reporting rule (e.g., a manufacturer 

previously reported the production 

volume to CDR for a particular year) 

does not necessarily mean that the same 

quantity or information would be 

accurate for this rule’s purposes. 

Because this rule does not provide for 

the same exemptions as the rules 

discussed in Unit III.F., the 

manufacturer must ensure that all 

quantities and other requested 

information for that PFAS are reported 

under this rule to the extent such 

information is known or reasonably 

ascertainable. In the previous example 

of a CDR reporter who had previously 

reported a PFAS’s production volume, 

the reporter must ensure that all 

manufactured quantities covered under 

this rule (including those that are 

exempt from CDR, such as impurities or 

imported articles) are accounted for. If 

a previous submission for a data 

element does not account for all covered 

volumes or activities, then the submitter 


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may not rely on that prior submission to 

satisfy the reporting requirements of this 

rule. 

EPA considered other previous 

information collection requests related 

to PFAS but did not determine those to 

be ‘‘duplicative’’ such that reporting 

may be exempt under TSCA section 

8(a)(5)(A). For instance, EPA received 

many public comments asserting that 

information submitted through a PMN is 

duplicative of the information that 

would be collected through this rule. 

EPA disagrees. Information collected 

through a PMN (or an LVE) reflects 

information before manufacture of a 

substance commences. 

EPA notes that the Agency has also 

required the submission of information 

on PFAS using a variety of enforcement 

authorities under different 

environmental statutes. However, most, 

if not all, of the information collected in 

the course of investigating potential 

non-compliance with, or liability under, 

TSCA or other statutes is different in 

numerous respects from information 

requested pursuant to this rule. EPA 

does not anticipate there to be 

duplicative reporting as the enforcement 

requests are generally narrower in 

scope. The enforcement requests 

generally focus on fewer years than this 

rule’s reporting period, and those 

requests tend to focus on far fewer 

substances. Additionally, the requested 

data for enforcement authorities is both 

aggregated and reported in formats 

differently than this rule’s requirements. 

While this rule requires data to be 

reported for each year over the reporting 

period in which the PFAS was 

manufactured, some enforcement 

requests have focused on just single 

years, or have requested quantities to be 

reported to reflect cumulative totals 

over multiple years. In that latter 

example, such a submission would not 

satisfy EPA’s obligations under TSCA 

section 8(a)(7) requesting certain 

information ‘‘for each year since January 

1, 2011.’’ In terms of information 

reporting formats, EPA notes that 

enforcement requests may often ask for 

responses in a narrative format, distinct 

from this rule’s requests for information 

in quantities or within specific ranges. 

For these discrepancies, EPA does not 

believe that most information requested 

through previous enforcement request 

letters is duplicative of information 

requested under this rule. 

The only information that may have 

been submitted in response to past 

enforcement letters that may be 

potentially duplicative of this rule 

relates to ‘‘all existing information 

concerning environmental and health 

effects.’’ Such information includes but 

is not limited to environmental 

monitoring, sampling, or worker 

exposure data. Thus, if a manufacturer 

has previously submitted certain 

information concerning environmental 

or health effects of a PFAS to EPA under 

an enforcement authority, that 

manufacturer does not need to resubmit 

that environmental or health effects 

information to EPA under this rule, 

provided that the manufacturer 

indicates to which program or office and 

in which year such information was 

submitted to EPA. 

While the use of those enforcement 

authorities may be duplicative in some 

cases, the information is needed to 

ensure protection of public health and 

the environment in instances where the 

Agency feels it needs information from 

an entity to make that judgment call and 

determine if action is needed. Therefore, 

information duplication between 

previous enforcement requests and this 

rule is unlikely for many reasons, 

including various limitations on 

information gathered under the 

enforcement authorities and the 

fundamental differences in the type of 

information sought under this rule as 

compared with the information gathered 

under the other authorities. While 

information from PFAS manufacturers 

requested by EPA is, in all cases, needed 

to ensure the protection of public health 

and the environment, the information 

requested under the different authorities 

serves different purposes. EPA has 

determined that the information 

submitted in response to an 

enforcement letter is not duplicative of 

the information requested under this 

rule, except for certain information 

concerning environmental and health 

effects. 

Finally, some reporters may also have 

submitted certain information 

concerning environmental or health 

effects of a PFAS pursuant to either a 

TSCA section 4 action or voluntarily, in 

conjunction with EPA’s National PFAS 

Testing Strategy. To the extent a 

reporting entity has already provided 

information concerning environmental 

or health effects (such as chemical and 

physical properties, hazard testing, or 

exposure testing), that entity need not 

resubmit the information to this 

reporting rule. Instead, the reporter 

should indicate that they have already 

submitted such information to EPA and 

provide the program, the specific 

chemical identity, the date, and an 

associated case number, if available, of 

that submission. 

G. What are the requirements for 

submitting CBI claims? 

The 2016 amendments to TSCA 

included new procedural requirements 

for the submission and Agency 

management of CBI claims, including 

new substantiation requirements, 

generic name requirements, a 

certification requirement, and a 

requirement for Agency review of 

specified CBI claims within 90 days 

after receipt of the claim (15 U.S.C. 

2613). In accordance with the 2016 

TSCA amendments, the Agency recently 

proposed a rule addressing the 

procedures for submitting CBI claims to 

EPA under TSCA and the procedures for 

EPA’s review of such claims (87 FR 

29078, May 6, 2022 (FRL–8223–01– 

OCSPP)). PFAS manufacturers reporting 

under this rule may claim certain 

portions of the reporting form are CBI 

confidential business information, 

consistent with TSCA section 14, such 

as specific chemical identities that are 

not on the public Inventory, company 

identifier, and production volumes. 

Only confidentiality claims made 

through this rule’s PFAS reporting tool 

will be considered properly asserted; 

any additional TSCA CBI claims made 

elsewhere will be considered 

improperly presented and will not be 

treated as having asserted a CBI claim 

under TSCA, and the information may 

be disclosed to the public without 

further notice. In addition to the 

requirement that CBI claims be 

submitted through the PFAS reporting 

tool, TSCA requires the reporter to 

certify that it has: (1) Taken reasonable 

measures to protect the confidentiality 

of the information; (2) Determined the 

information is not required to be 

disclosed or made public under Federal 

law; (3) A reasonable basis to believe 

that disclosure of the information is 

likely to cause substantial competitive 

harm; and (4) A reasonable basis to 

believe that the information is not 

readily discoverable through reverse 

engineering; and, (5) To certify that 

these statements and any information 

provided are true and correct. 

Consistent with the format of other 

TSCA reporting forms, the statements 

and certification would be combined 

into a single certification statement. 

Information under this rule that may 

not be asserted as CBI includes: 

• Specific chemical identity if the 

chemical is on the public (nonconfidential) Inventory or reported as 

non-confidential in an LVE; 

• All generic chemical names; 

• For any PFAS that are on the public 

(non-confidential) Inventory, the 

chemical’s CASRN; 


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• For PFAS that are on the 

confidential Inventory, the Inventory 

Accession Number cannot be claimed as 

CBI (but the underlying chemical 

identity can be claimed as CBI); 

• LVE numbers; 

• The following categories of use 

information: industrial processing and 

use type, sector, and functional 

categories, whether a chemical is in a 

consumer and/or commercial product, 

the consumer/commercial product 

categories and functional categories, and 

its presence in products for children; or 

• Any blank or NKRA designation or 

response. 

Any entity that claims a specific 

chemical identity as CBI must also 

submit a generic name pursuant to 

TSCA section 14(c)(1)(C). This includes 

reporting a PFAS by either an Accession 

number or LVE number (assuming that 

the specific chemical identity is not on 

the public Inventory), or reporting by a 

CAS name on a PFAS for which the 

CASRN, Accession number, and LVE 

number are not known to be assigned 

(i.e., the CASRN and specific identifiers 

have not been created or generated). 

Entities must ensure that that any such 

generic name is consistent with EPA’s 

Generic Name Guidance (Ref. 19). The 

generic name must also ‘‘describe the 

chemical structure of the chemical 

substance as specifically as practicable 

while protecting those features of the 

chemical structure that are claimed as 

confidential; and the disclosure of 

which would be likely to cause 

substantial harm to the competitive 

position of the person.’’ 15 U.S.C. 

2613(c)(1)(C)(ii). Generic names must be 

sufficiently detailed to identify the 

reported chemical as a PFAS. 

Specifically, any generic name reported 

for a PFAS that does not contain ‘‘fluor’’ 

in the name would be rejected by EPA 

as insufficient under TSCA section 

14(c)(1)(C). As the Agency described in 

the NODA published for this rule (Ref. 

1), any generic name for a PFAS 

(including previously existing generic 

names from earlier TSCA section 5 

submissions) that does not contain 

‘‘fluor’’ in the name is inconsistent with 

this provision and will be rejected. 

Ultimately, if a generic name reported 

under the TSCA section 8(a)(7) rule 

lacks the structural unit ‘‘fluor,’’ the 

Agency will publicly identify the 

chemical substance as a PFAS. 

TSCA section 14 further requires that 

substantiation be provided for each data 

element claimed as CBI. The 

substantiation must be provided at the 

time of submission. However, TSCA 

section 14(c)(2) exempts certain 

information from the substantiation 

requirements (e.g., specific production 

volume). Under this rule, CBI claims for 

specific production or import volumes 

of the manufacturer need not be 

substantiated. Additionally, the specific 

chemical identity and molecular 

structure need not be substantiated 

when the substance has not been 

introduced into commerce (e.g., an R&D 

substance manufactured in small 

quantities meeting the new chemical 

reporting exemption under section 

5(h)(3)). No other TSCA section 14(c)(2) 

exemptions apply to information 

requested under this rule, so CBI claims 

must be substantiated for all other such 

information. Any information which is 

claimed as CBI will be disclosed by EPA 

only in accordance with the procedures 

and requirements of TSCA section 14 

and 40 CFR parts 2 and 703. TSCA 

limits CBI protections for information in 

health and safety studies. 

Generally, information from health 

and safety studies is not protected from 

disclosure, except to the extent such 

studies or information reveal 

information ‘‘that discloses processes 

used in the manufacturing or processing 

of a chemical substance or mixture or, 

in the case of a mixture, the portion of 

the mixture comprised by any of the 

chemical substances in the mixture,’’ 15 

U.S.C. 2613(2)(B). Additional 

information, listed in the rule’s 

definition of health and safety study, are 

not part of a health and safety study 

(e.g., names of laboratory personnel). 

Submitters asserting a CBI claim for 

information under § 705.15(f) are 

required to submit a sanitized copy, 

removing only the information that is 

claimed as CBI. 

EPA expects that article importers 

generally do not know the Accession 

number or other specific identifiers 

(e.g., PMN or LVE number) for a 

confidential Inventory chemical that 

may be included in the article they are 

importing. As a result, article importers 

must report chemical identities to the 

extent that they are known to or 

reasonably ascertainable (generic name, 

trade name, or CASRN if it is a publicly 

known chemical substance) and use the 

article importer streamlined form. 

Public identifiers like generic names 

and public Inventory CASRNs may not 

be claimed as CBI and it is unnecessary 

for article importers to assert CBI claims 

for the specific identities of substances 

that are not reported by a specific 

identifier (i.e., Accession number or 

LVE number). EPA would not be able to 

determine an underlying confidential 

chemical identity from this generic 

identifying information, so could not 

disclose that specific chemical identity, 

regardless of whether the submitter 

asserted a CBI claim. It would be 

purposeless for the submitter to assert a 

CBI claim for this information or for 

EPA to review such claims. In this 

TSCA section 8(a)(7) rule, and for these 

reasons, EPA believes that it is 

appropriate to differentiate article 

importers from other reporters with 

respect to chemical identity CBI claims. 

However, all other entities (i.e., other 

than article importers) who report a 

CAS name, CASRN, or specific 

identifier (i.e., Accession number, LVE 

number) must assert and substantiate a 

CBI claim for the specific chemical 

identity if the reporter wants the 

chemical identity to receive confidential 

treatment. A person or entity (other than 

an article importer) who does not have 

knowledge of such an identifier (CAS 

name, CASRN, Accession number, or 

LVE number) must initiate a joint 

submission with its supplier or other 

entity who can provide this identifying 

information, if such an entity is known 

to or reasonably ascertainable by the 

manufacturer. In these cases, the 

secondary submitter would be 

responsible for providing the CAS 

name, CASRN, Accession number, or 

LVE number and for asserting and 

substantiating any CBI claims 

concerning the chemical identity (see 

e.g., 40 CFR 711.15(b)(3); 711.30(c)). In 

light of the extended timeframe (11 

years) covered by this reporting rule, it 

is possible that the submitter’s supplier 

is unknown or no longer exists (e.g., 

supplier has gone out of business 

without a successor entity). As applied 

to this reporting rule only, a submitter 

who lacks knowledge of the CAS name, 

CASRN or a specific identifier (i.e., 

Accession number or LVE number) and 

who—after conducting due diligence 

and reviewing known or reasonably 

ascertainable existing information— 

cannot identify a supplier or any other 

entity who could provide this 

information in a joint submission, the 

submitter would indicate that secondary 

submitter information is not known or 

reasonably ascertainable and therefore 

does not need to initiate a joint 

submission. 

Generally, reporting entities will not 

have an opportunity to add or modify 

substantiations once the reporting 

period concludes. Therefore, reporting 

entities should communicate with 

suppliers, or any other entities with CBI 

concerns (e.g., non-disclosure 

agreements) and carefully consider the 

CBI implications of this rule. However, 

reporting entities may amend their 

submission to withdraw CBI claims at 

any time during the reporting period. 

In response to comments received on 

CBI claims concerning the specific 

chemical identity, following the 


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conclusion of the reporting period for 

this rule, EPA will compile a list of 

reported substances it plans to move to 

the public Inventory because either no 

chemical identity CBI claim was 

asserted, or the claim was denied. 

Similar to past compilations, EPA will 

publish a list of Accession numbers 

associated with these substances on the 

EPA website for several months in 

advance of any update to the Inventory. 

Interested parties will have an 

opportunity to review the list for 

possible errors and contact EPA with 

any questions or concerns about specific 

candidates. In some cases, there may be 

assertions by a company that a mistake 

has been made (e.g., the wrong chemical 

identity was reported by a third party) 

or that a waiver of a CBI claim was 

made by a company that may not know 

the specific chemical identity, in which 

case EPA will undertake appropriate 

factual investigations as necessary to 

confirm whether EPA should reconsider 

whether the chemical is no longer 

entitled to confidential Inventory 

protection. Where EPA determines that 

a chemical identity was identified as a 

candidate for disclosure because there 

was an error or because the sole basis 

for the proposed move to the public 

portion of the Inventory was a waiver of 

a CBI claim by an entity that did not 

know the specific chemical identity, it 

will not move the chemical identity to 

the public portion of the Inventory. This 

investigation would take place prior to 

the point that the specific chemical 

identity would be disclosed on the 

public Inventory. 

H. What are the electronic reporting 

requirements? 

EPA is requiring all information to be 

submitted electronically, similar to the 

requirements established in 2013 for 

submitting other information under 

TSCA (see 40 CFR 704.20(e)). Reporters 

must use EPA’s Central Data Exchange 

(CDX), the Agency’s electronic reporting 

portal, to submit all information under 

this rule. EPA developed the Chemical 

Information Submission System (CISS) 

for use in submitting data electronically 

to the Agency for TSCA sections 4, 5, 6, 

8(a), 8(b), 8(d), and 8(e) and Title VI. 

CISS, a web-based reporting tool housed 

within the CDX environment, provides 

submitters with user-friendly 

applications to build and submit data 

packages to EPA within a secure, 

encrypted environment. CISS 

applications provide for the capture of 

both fielded data as well as the 

attachment of additional information 

using a wide variety of file types. 

Within CDX, CISS is available under the 

‘‘Submission for Chemical Safety and 

Pesticide Program (CSPP)’’ CDX flow. 

Users who have previously submitted 

under TSCA through CDX, including 

submitting information under sections 4 

and 5, or CDR, will already have the 

CSPP flow linked to their account. Users 

reporting to EPA using other CDX 

housed applications, including the 

Toxics Release Inventory TRI–MEweb, 

would be able to add the CSPP flow to 

their existing CDX accounts. 

EPA is developing a rule-specific 

reporting tool within CISS, which 

reporters must use to submit the 

required information. This tool will be 

available in CISS prior to the start of the 

reporting period (see the discussion in 

Unit III.I on reporting deadlines). EPA 

believes that electronic reporting 

reduces the reporting burden for 

submitters by reducing the cost and 

time required to review, edit, and 

transmit data to the Agency. It also 

allows submitters to share a draft 

submission within their organization 

and more easily save a copy for their 

records or future use. Additionally, EPA 

believes that many of the anticipated 

reporters under this rule have 

experience with reporting electronically 

to EPA through CDX. For those reporters 

who do not have experience submitting 

information to EPA via CDX, EPA has 

provided guidance documents and 

support via a help desk to assist users 

with technical questions related to CDX. 

The resource and time requirements to 

review and process data by the Agency 

will also be reduced, and document 

storage and retrieval will require fewer 

resources. 

I. What if an entity who knows the 

specific chemical identity will not 

disclose it to the PFAS manufacturer 

(including importer)? 

In response to public comment, EPA 

is also enabling joint submissions for 

PFAS manufacturers (including 

importers) other than article importers 

who do not know the CASRN, 

Accession Number, and/or LVE number 

and whose suppliers will not disclose 

the identity to the PFAS reporter. 

Similar to the 2020 CDR cycle, this joint 

submission tool would allow 

manufacturers (including importers) to 

submit all importing, processing, use, 

and other information to the extent it is 

known or reasonably ascertainable and 

to send a request to the appropriate 

supplier or other entity to create a 

submission to supply the PFAS identity 

to EPA through the reporting tool. The 

joint submission process does not 

require the supplier or other entity to 

disclose the specific chemical identity 

to their customer, thus maintaining 

confidentiality between the two entities. 

The joint submission tool would be 

relevant when a manufacturer 

(including importer) cannot provide the 

CAS name, CASRN, Accession number, 

or LVE number of a chemical substance 

it manufactures, generally because it is 

unknown to the manufacturer 

(including importer) and claimed in part 

or in its entirety as CBI by the supplier 

of the chemical substance or mixture. 

In a joint submission, the primary 

submitter (i.e., the PFAS manufacturer) 

may assert CBI claims over some of their 

supplier information, including the 

supplier identity and the chemical 

substance or mixture trade name (or 

other designation). Substantiation of the 

CBI claims for this information will not 

be required at the time of the primary 

submitter’s submission. The secondary 

submitter of the joint submission must 

register with CDX if they have not 

previously and provide its company 

name and location, a technical contact, 

trade name, chemical identity, function, 

and, for PFAS in mixtures, the 

percentage of each PFAS in the mixture 

represented by the trade name. The 

secondary submitter is responsible for 

asserting all confidentiality claims for 

the data elements that it submits 

directly to EPA and for substantiating 

those claims not exempt under 40 CFR 

705.30(a)(2). The specific chemical 

identity may be claimed as CBI by the 

secondary submitter following the 

provisions in 40 CFR 705.30. If the 

secondary submitter does not assert and 

substantiate a CBI claim for the identity 

of the chemical substance in its 

response to the Agency, then the 

chemical is not entitled to confidential 

treatment. Except for the percentage 

composition information, which is 

generally exempt from substantiation 

pursuant to TSCA section 14(c)(2)(D), 

all other reported data elements are 

subject to substantiation at the time the 

information is submitted. 

Similar to the CDR joint submissions, 

any secondary submitter in this rule 

will be able to request the chemical 

information from their own suppliers as 

needed, should the importer’s direct 

supplier not have the information. 

There may be instances where a foreign 

supplier purchases a mixture, under a 

trade name, from another company 

(tertiary company) and does not know 

the chemical components of the 

mixture. The foreign supplier can ask 

the tertiary company manufacturing the 

trade secret mixture or PFAS within the 

mixture to directly provide EPA with 

the correct chemical identity in the 

reporting tool. In this case, the tertiary 

company would register with CDX and 

use the Unique Identifier for Joint 

Submissions, sent to the tertiary 


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company by the secondary company 

(i.e., the foreign supplier), to complete 

the reporting form. 

Under this scenario, the foreign 

supplier does not have access to any of 

the information submitted to EPA by the 

tertiary company. Likewise, the tertiary 

company cannot see the information the 

foreign supplier or the primary 

company (i.e., the U.S. manufacturer 

(including importer)) reports to EPA. 

This way, the confidentiality of 

information for all parties is protected. 

EPA believes this functionality 

addresses some concerns that have been 

voiced from stakeholders, including an 

importer’s direct (or immediate) 

supplier may not have knowledge of the 

PFAS identity. By allowing a foreign 

supplier (secondary submitter) to 

request the required information from 

their own supplier (a tertiary submitter) 

as needed, EPA believes this will 

capture more information related to 

specific PFAS identities that may not be 

known to the importer due to 

confidentiality or trade secret claims, 

while not requiring suppliers to share 

any information they wish to protect 

from their customers. 

Joint submissions are to be used only 

in cases when the PFAS reporter does 

not know the CAS name, CASRN, 

Accession number, or LVE number for 

the PFAS, but another entity (e.g., a 

supplier or other manufacturer) does 

and will not disclose it to the reporter. 

If a reporter (including importer) or joint 

reporter (secondary or tertiary 

submitter) actually knows or can 

reasonably ascertain the CAS name, 

CASRN, Accession number, or LVE 

number of a PFAS, the reporter 

(including importer) must provide that 

information irrespective of others’ 

confidentiality claims. If the reporter 

wishes to claim the specific chemical 

identity as confidential, the chemical 

substance must not be listed on the 

public portion of the Inventory, the 

submitter must check the CBI box in the 

reporting tool and provide the 

appropriate substantiation. Such a CBI 

claim only relates to the specific 

chemical identity as listed on the 

confidential portion of the Inventory 

(i.e., CAS name and/or CASRN) and 

does not apply to the Accession number 

and generic name listed on the public 

portion of the Inventory. 

Because article importers are not 

required to assert or substantiate CBI 

claims for the chemical identity for this 

rule, EPA is not requiring or enabling 

joint submissions for article importers 

when they do not know the CAS name, 

CASRN, Accession number, or LVE 

number of the PFAS. Additionally, in 

scenarios where a secondary submitter 

is not known or existent (e.g., a supplier 

has gone out of business and does not 

have a successor entity), the primary 

submitter would indicate in the 

reporting tool that the secondary 

submitter is ‘‘not known or reasonably 

ascertainable.’’ In this case, however, 

the PFAS manufacturer would be 

required to provide as much identifying 

detail as they have regarding the PFAS 

identity (e.g., trade name), but would be 

able to report to EPA without initiating 

a joint submission. 

J. When are reports due? 

EPA proposed a six-month 

information collection period following 

the effective date of the final rule, then 

a six-month reporting period. Thus, the 

proposed rule stipulated a reporting 

deadline one year following the 

effective date of the final rule. EPA 

received many public comments on the 

reporting timeframe, which are detailed 

in Unit IV.K. 

In response to public comment, EPA 

has decided to finalize a one-year 

information collection period following 

the effective date of this rule, which will 

then be followed by a six-month 

reporting period. Further, EPA is 

granting an additional six months for 

reporting to small manufacturers (as 

defined at 40 CFR 704.3) whose 

reporting obligations under this rule are 

exclusively from article import. ‘‘Small 

manufacturers’’ as defined at 40 CFR 

704.3 include manufacturers who meet 

one of two standards: (1) a manufacturer 

(including importer) whose total annual 

sales, when combined with those of its 

parent company, are less than $120 

million, and the annual production 

volume of a chemical substance is less 

than 100,000 lbs; or (2) a manufacturer 

(including importer) whose total annual 

sales, when combined with those of its 

parent company, are less than $12 

million. EPA acknowledges that the 

scope of reporting for this rule is 

broader than for CDR, and that there 

may be some reporting entities who 

have not submitted information to EPA 

under a TSCA section 8(a) reporting rule 

before (e.g., some small manufacturers). 

Therefore, EPA agrees that additional 

time is warranted for PFAS 

manufacturers to familiarize themselves 

with the scope of the reporting rule and 

reporting standard, as well as begin to 

collect the required information and 

create a CDX account if necessary. The 

extended time period for information 

collection also benefits both EPA and 

the reporting community by providing 

the Agency with additional time to 

develop and test the CDX reporting 

application for this rule. Thus, reporting 

forms will be due 18 months following 

the effective date of this rule, except for 

small article importers (as defined at 40 

CFR 704.3), whose reporting forms are 

due 24 months following the effective 

date of this rule. 

K. What are the recordkeeping 

requirements? 

EPA is finalizing the proposed 

recordkeeping requirements. Each 

person who is subject to the reporting 

requirements must retain records that 

document any information reported to 

EPA for five years, beginning on the last 

date of the information submission 

period. The five-year retention 

requirement is consistent with the CDR 

rule and corresponds with the statute of 

limitations for violations and is 

necessary to preserve records to support 

future regulatory activities that will be 

informed by this information collection. 

Further, EPA believes the burden of 

retaining these records, which are likely 

electronic, is minimal. 

L. Which proposed requirements are not 

being finalized as proposed? 

EPA is modifying the following items 

from the proposed rule: the definition of 

‘‘PFAS’’; the reporting deadline; some of 

the data elements requested; enabling 

streamlined reporting options for article 

importers and manufacturers of R&D 

substances below 10 kilograms; enabling 

joint submissions; and [certain waste 

management/disposal facility 

exemptions]. 

As noted in Unit III.A.1, this rule 

defines ‘‘PFAS’’ as including at least 

one of these three structures: 

• R-(CF2)-CF(R′)R′′, where both the 

CF2 and CF moieties are saturated 

carbons; 

• R–CF2OCF2-R′, where R and R′ can 

either be F, O, or saturated carbons; and 

• CF3C(CF3)R′R′′, where R′ and R′′ can 

either be F or saturated carbons. 

This definition is an expansion of the 

proposed definition of ‘‘PFAS’’, which 

was defined as R-(CF2)-CF(R′)R′′, where 

both the CF2 and CF moieties are 

saturated carbons, and none of the R 

groups can be hydrogen. The proposed 

definition defined PFAS as a substance 

that includes the following structure: R- 

(CF2)-C(F)(R′)R′′, in which both the CF2

and CF moieties are saturated carbons 

and none of the R groups (R, R′ or R′′) 

can be hydrogen. The proposed 

definition, which existed previously in 

EPA’s Office of Pollution Prevention 

and Toxics (OPPT), was developed to 

focus on chemical substances in the 

Inventory with properties similar to 

PFOA, PFOS, and GenX. EPA notes that 

the proposed definition of ‘‘PFAS’’ had 

previously been used by OPPT, 

although this definition has changed 


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over time. For instance, the polymer 

exemption for PMNs provided a 

different definition of ‘‘perfluoroalkyl’’ 

in its PFAS exception rule in 2010 (40 

CFR 723.250) (Ref. 20). Over many years 

of research and data collection, EPA 

continues to learn more about these 

substances and may consider whether 

modifications to the definition are 

appropriate. See Unit IV.A.1 for a more 

detailed discussion of EPA’s reasons for 

modifying this definition for this rule. 

EPA is also modifying the reporting 

deadline from the proposed rule. As 

noted in Unit III. J, EPA believes 

additional time for rule familiarization 

and data collection is warranted given 

the lookback period of this rule and that 

there are entities that are potentially 

covered by this rule which have not 

been previously required to respond to 

other TSCA section 8 reporting rules, 

such as CDR. Given public comments 

and input during the SBAR Panel, EPA 

is providing a one-year period following 

the effective date of this rule for data 

collection, followed by a six-month 

reporting period during which the 

reporting application will be open. EPA 

is further granting an additional six 

months for reporting to small 

manufacturers (as defined at 40 CFR 

704.3) who would report exclusively as 

article importers for the purpose of this 

rule. Thus, reporting forms are due 18 

months following the effective date of 

this rule, except for small article 

importers, which are due 24 months 

from the effective date of this rule. 

EPA is slightly modifying the data 

elements requested by PFAS 

manufacturers. Based on public 

comments, EPA is not including the 

following proposed data elements 

within this rule: the maximum quantity 

on-site at any time, including storage; 

the maximum first 12 months 

production volume, and the maximum 

yearly production volume in any 3 

years. EPA received public comment 

that it is unlikely that manufacturers 

have information related to the storage 

quantities, and other comments stated 

that requesting the maximum 

production quantities in either the first 

12 months or in any three years may be 

duplicative of other production volume 

data requested. Therefore, EPA is 

removing these three items from the 

scope of the final rule. For more 

discussion on the comments received on 

the scope of data elements, see the 

Response to Comments document (Ref. 

21). 

Pursuant to public comments, EPA is 

also modifying the request for the 

molecular structure of the PFAS in all 

reports: submitting molecular structure 

of the reported PFAS is optional for any 

Class 1 PFAS on the Inventory. Class 1 

chemical substances are those chemical 

substances composed of molecules with 

particular atoms arranged in a definite, 

known structure. If a Class 1 substance 

is also on the Inventory, EPA knows its 

particular molecular structure. 

However, many commerciallymanufactured chemicals are not Class 1 

substances (i.e., they are Class 2 

substances comprised of specific 

molecular formula representations in 

variable structures, or they have 

unknown or indefinite molecular 

formulas and/or incomplete structural 

diagrams). Additionally, not all 

commercially-manufactured substances 

that are subject to TSCA may be on the 

Inventory due to various reporting 

exemptions. While EPA has the 

authority and obligation to request the 

molecular structure of any reported 

PFAS pursuant to TSCA section 

8(a)(2)(A), EPA does already know the 

structure of Class 1 substances on the 

Inventory; thus, pursuant to TSCA 

section 8(a)(5)(A), EPA is limiting the 

scope of this reporting requirement in 

cases where the information would be 

duplicative of information EPA has 

obtained through TSCA reporting. 

Therefore, EPA is modifying the 

proposed rule by limiting the reporting 

requirement of molecular structures to 

those PFAS that are not Class 1 

substances on the Inventory. 

Finally, EPA is also modifying the 

proposed data elements for worker 

exposure duration. EPA proposed to 

request information on worker exposure 

for the manufacturing site, each 

industrial process and use, and each 

commercial use. For all three categories, 

EPA proposed to request ‘‘maximum 

duration of exposure for any worker’’ in 

both hours per day and days per year. 

However, following the publication of 

the proposed rule, EPA understands that 

the worker exposure duration 

information, as proposed, could lead to 

a manufacturer reporting unassociated 

variables; that is, the worker with the 

maximum duration of exposure in hours 

per day is not the same as the worker 

with the maximum duration of exposure 

in days per year. Without additional 

clarifying information on which 

worker(s) the reported durations reflect, 

such a request may not yield data useful 

for EPA’s assessments. EPA is therefore 

modifying the proposed request for the 

worker exposure duration data by 

clarifying the workers for whom the 

maximum exposure durations or 

frequency must be reported. EPA is 

requesting worker exposure duration 

information (in hours per day and days 

per year) both for the worker with the 

greatest daily exposure duration (i.e., 

the worker with the greatest exposure in 

hours per day) and for the worker with 

the greatest annual exposure frequency 

(i.e., the worker exposed during the 

most days per year). 

Additionally, EPA is modifying the 

scope of data elements requested for 

some article importers and 

manufacturers of R&D substances in 

quantities below 10 kilograms annually. 

Based on feedback through public 

comments and the SBAR Panel, EPA 

understands that some article importers 

and some manufacturers of R&D 

substances may not know or be able to 

ascertain all information being 

requested. Therefore, EPA is offering 

two streamlined reporting options for 

those manufacturers. (For more 

information on these reporting options, 

see additional discussions in Units 

III.D.2 and III.D.3.) 

EPA is also modifying the proposed 

rule by enabling joint submissions. In 

the proposed rule, EPA did not propose 

joint submissions, but did specifically 

request comment on whether to enable 

them for this rule in cases where a 

supplier may not disclose the chemical 

identity to an importer who is covered 

by this reporting rule. Following public 

comments, EPA is finalizing this rule to 

include joint submissions for situations 

in which an importer does not know the 

CASRN or specific identifier (i.e., 

Accession number or LVE number) (see 

Unit III.I.). EPA further discussed 

requiring submitters who lack 

knowledge of a chemical’s specific 

chemical identity to initiate a joint 

submission in the NODA. 

Finally, EPA is modifying the scope of 

reportable activities under this rule to 

clarify that importing municipal solid 

waste streams for the purpose of 

disposal or destruction is not a 

reportable activity under this rule. As 

explained in Unit III.B.3., EPA learned 

through public comments and the SBAR 

Panel that entities engaged in certain 

municipal solid waste management 

activities are in the unique position of 

not having any knowledge of the 

contents of the municipal solid waste 

they have imported. Therefore, 

extending reporting requirements to 

such sites would not result in any 

responsive information under TSCA 

section 8(a)(7), and EPA does not 

consider the import of municipal solid 

waste for the purpose of disposal or 

destruction to be a reportable activity. 

IV. Summary of Comments and Other 

Public Input and EPA’s Response 

EPA received 109 unique public 

comments during the proposed rule’s 

public comment period. Following 


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publication of the proposed rule, EPA 

received more data related to the 

proposed rule’s burden and cost 

estimates. At the time of the proposed 

rule’s publication, EPA did not have 

sufficient and reliable data to inform an 

estimate of the scope of article importers 

that may be affected by the proposed 

rule’s requirements. However, after 

receiving comments through the docket 

related to the scope of article importers 

(including estimates provided by 

companies and industry trade 

associations), and through the discovery 

of additional information and data 

sources related to the scope of 

potentially affected article importers, 

EPA determined the proposed rule 

could no longer support a certification 

under the Regulatory Flexibility Act 

(RFA), 5 U.S.C. 601 et seq., that there 

would be no significant economic 

impact on a substantial number of small 

entities. Specifically, the number of 

small businesses who may be 

considered importers of PFAScontaining articles and therefore 

potentially affected by the proposed rule 

was estimated to be approximately 

130,000. Thus, EPA convened an SBAR 

Panel under the RFA to hear directly 

from small entities on the anticipated 

impact of the proposed rule on their 

organizations, and to hear feedback 

regarding recommended paths forward 

to finalize a rulemaking that would 

minimize the burden of compliance on 

small entities while still achieving the 

objectives of TSCA section 8(a)(7). This 

Panel convened in April 2022, with a 

Panel Outreach meeting conducted on 

April 20, 2022. The Panel (which 

included EPA, Office of Management 

and Budget (OMB), and Small Business 

Administration (SBA) representatives) 

used feedback from the small entity 

representatives submitted during and 

after the Outreach meeting to develop 

its Panel Report (Ref. 22), which 

included recommendations for EPA to 

consider in its final rule. 

Along with public comments on the 

overall cost estimates of the 2021 

proposed rule, EPA received many 

public comments both in support of and 

against EPA’s position to not exempt 

entities or activities that are often 

exempt under CDR, including small 

manufacturers and article importers, 

and the use of a structural definition for 

PFAS rather than a discrete list of 

substances. 

Following this Panel, EPA published 

a NODA (Ref. 1) to solicit public 

comment on the rule’s IRFA and other 

aspects of the proposed rule that may 

have been impacted by EPA actions or 

proposed actions since the public 

comment period had closed for the 

proposed rule in September 2021. EPA 

also published the SBAR Panel Report 

(Ref. 22) for public comment. The notice 

was published on November 25, 2022 

(Ref.1), for a 33-day public comment 

period ending on December 27, 2022. 

EPA received 44 unique public 

comments during the public comment 

period following the publication of the 

NODA (Ref. 1). Comments largely 

focused on different regulatory 

alternatives presented in the Panel 

Report (including certain exemptions, or 

using a discrete list of covered PFAS) 

and on EPA’s discussion of its approach 

to CBI claims of the chemical identity. 

EPA considered all comments and 

other stakeholder input, including from 

the SBAR Panel, in the development of 

this final rule. This unit discusses many 

of the comments on the proposed rule 

received through both avenues and the 

Agency’s responses; however, the more 

comprehensive response to comments 

related to this rule can be found in the 

Response to Comments document, 

which is available in the docket for this 

rulemaking (Ref. 21). 

A. What is the proposed definition of 

covered substances? 

1. Summary of Public Input 

Many commenters provided feedback 

on the specific definition of PFAS in the 

proposed rule. These commenters either 

were unsupportive of EPA’s definition 

and requested that the Agency narrow 

the proposed definition of PFAS or 

requested that EPA broaden their 

definition of PFAS, while generally 

supporting EPA’s proposed structural 

definition. 

Commenters who were generally 

unsupportive of EPA’s proposed 

definition of PFAS noted that ‘‘the 

proposed rule contains a definition of 

‘PFAS’ not recognized by any other 

federal agency or international 

organization, and which EPA itself does 

not use consistently.’’ One commenter 

mentioned that treating PFAS as a single 

group or class of chemicals is ‘‘not 

scientifically sound or appropriate’’ due 

to it being ‘‘over- and under-inclusive.’’ 

Another commenter stated that EPA’s 

proposed definition of PFAS is overly 

expansive ‘‘because it includes 

molecules that are not obviously PFAS’’ 

such as ‘‘highly fluorinated molecules 

that are not PFAS by any common 

understanding of PFAS.’’ This 

commenter suggested that the definition 

of PFAS in the final rule ‘‘hew much 

more closely to the types of PFAS 

molecules that motivated Section 7351 

of the NDAA 2020.’’ Commenters who 

suggested that EPA’s proposed PFAS 

definition is overly broad, also 

suggested that an overly broad PFAS 

definition will ‘‘almost certainly’’ result 

in unnecessary reporting of ‘‘PFAS 

molecules’ that are ‘‘likely unrelated to 

the underlying problems.’’ 

Some commenters suggested that EPA 

use the OECD definition of PFAS, with 

a few commenters recommending that 

EPA define PFAS ‘‘at least as broadly as 

the recent OECD definition.’’ Supporters 

of adopting the OECD definition 

claimed that the OECD definition 

incorporates sound science based on 

input from the ‘‘world’s leading 

developed countries, including 

scientists from EPA’’ and mentioned 

that it might make reporting compliance 

easier for PFAS manufacturers who 

have a global presence. Another 

commenter who supported use of the 

OECD definition mentioned that EPA’s 

proposed definition excludes ‘‘many 

PFAS of known concern, undercutting 

the benefits of the Agency’s actions.’’ 

A few commenters who claimed that 

EPA’s proposed PFAS definition is 

overly narrow, mentioned that other 

regulatory agencies in some states have 

taken a ‘‘class-based approach’’ to PFAS 

by regulating them as a chemical class. 

Commenters specifically cited Vermont, 

Massachusetts, and California as 

examples of States that are regulating 

PFAS in this way, ‘‘given that all PFAS, 

or their degradation, reaction, or 

metabolism products, display 

commonly hazardous traits.’’ Some 

commenters pointed to additional States 

(Colorado, Maine, Washington) that 

have adopted or are considering 

adopting a broader definition of PFAS 

similar to the OECD definition. 

2. EPA’s Response 

EPA appreciates that there are 

differences between the definition of 

PFAS used for this rule, for other 

actions in the Agency, and by non-EPA 

entities. While EPA’s rule is not dictated 

by the definitions used by other 

regulatory bodies or international 

organizations, the Agency did consider 

adopting the different definitions 

suggested by the commenters, but 

ultimately determined those definitions 

would not satisfy EPA’s obligations 

under TSCA section 8(a)(7). In the 

development of this proposed 

definition, EPA intended to include 

substances with a strong electron 

withdrawing nature as this greatly 

effects the chemistry of the substituted, 

adjacent and nearby atoms, meaning 

they would have a minimum of two 

fluorine atoms on at least one carbon 

(e.g., -CF2-). Additionally, EPA wanted 

the covered substances to be unlikely to 

degrade or metabolize, so an adjacent 

CF group was added to the requirement/ 


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definition, with the stipulations that the 

substitutions could not be H and both 

carbons must be saturated (e.g., -CF2- 

CFR-). EPA also thought that branching 

might make a chemical less susceptible 

to degradation and metabolism, so EPA 

also removed the option for -CF2-CF2- 

when developing the proposed 

definition. 

After reviewing public comments, 

EPA is modifying the proposed 

definition of PFAS. For the purposes of 

this section 8(a)(7) reporting rule, EPA 

is defining ‘‘PFAS’’ using a structural 

definition. PFAS is defined as including 

at least one of these three structures: 

• R-(CF2)-CF(R′)R′′, where both the 

CF2 and CF moieties are saturated 

carbons; 

• R-CF2OCF2-R′, where R and R′ can 

either be F, O, or saturated carbons; and 

• CF3C(CF3)R′R′′, where R′ and R′′ can 

either be F or saturated carbons. 

For the purposes of this rule, EPA has 

defined PFAS to include chemical 

substances whose structures or substructures resemble, at least in part, 

chemicals widely known to be of 

concern to human health and/or the 

environment, i.e., PFOA, PFOS, and 

GenX. The definition also captures 

substances that may metabolize or 

degrade to PFAS which may present 

similar properties to PFOA, PFOS, or 

GenX. This definition is focused on 

substances likely to be present in the 

environment, thereby focusing on 

substances with greater potential for 

exposures to people and/or the 

environment and by extension more 

potential to present risks. 

EPA considered adopting OECD’s 

definition for the purpose of this rule, 

but for the reasons provided in this unit, 

determined it is not appropriate to do 

so. First, EPA notes that ‘‘alkyl’’ means 

an alkane missing one hydrogen, and 

acyclic alkyl has the general formula of 

CnH2(n∂1), while a cycloalkyl has the 

general formula CnH2(n¥1). Rather than 

limiting the definition of PFAS to alkyl 

chains, the OECD definition covers, 

with certain exceptions, any chemical 

with one or more fluorinated alkyl 

groups (i.e., -CF2-, -CF3). Many chemical 

substances covered by the OECD 

definition are unlike the structures of 

the PFAS of concern (i.e., PFOA, PFOS, 

GenX), which have more fluorinated 

carbons and are more likely to be 

present in the environment. The 

substances with only single fluorinated 

alkyl groups and no additional 

fluorinated moieties do not share the 

same environmental and/or human 

health impacts (including 

bioaccumulation, persistence, or 

toxicity) as substances such as PFOA, 

PFOS, or GenX. Further, many 

substances with one terminal -CF3 (e.g., 

trifluoroacetic acid (TFA)) are wellstudied. Using structures in the 

CompTox Chemicals Dashboard, EPA 

estimates that approximately 23,000 

additional substances would be 

captured by the OECD definition, 

though approximately 17,000 of those 

would be covered only due to having 

one terminal -CF3 and no additional 

fluorine. Thus, adopting the OECD 

definition of PFAS in this rule would 

mainly serve to significantly add 

reporting burden on many substances 

whose only fluorine atom is in a 

terminal -CF3 and that do not share a 

fluorinated substructure that is likely to 

result in their persistence in the 

environment, nor to degrade to a 

substance that shares toxicological or 

physiochemical properties with PFOA, 

PFOS, or GenX. Therefore, EPA is using 

its authority under TSCA section 

8(a)(5)(A) to focus reporting on 

structures that contain at least one 

fluorinated alkyl chain rather than 

isolated fluorinated alkyl groups. 

Information on structures that would 

meet the OECD definition due to an 

isolated fluorinated alkyl group is 

considered ‘‘unnecessary’’ for the 

purpose of this rule and is out of scope 

of reporting requirements under EPA’s 

authority under TSCA section 

8(a)(5)(A). 

Further, OECD’s general definition is 

‘‘based on molecular structure alone’’ 

(Ref. 8). In its 2021 terminology 

document, OECD notes that the current 

definition ‘‘serves as a starting and 

reference point to guide individual 

users to have a comprehensive 

understanding of the PFAS universe and 

to keep the big picture of the PFAS 

universe in mind. At the same time, 

individual users may define their own 

working scope of PFASs for specific 

activities according to their specific 

needs by combining the general 

definition of PFASs with additional 

considerations (e.g., specific properties, 

use areas)’’ (Ref. 8). Accordingly, EPA 

determined it is appropriate to define 

‘‘PFAS’’ differently for this rule and to 

establish a definition which 

characterizes PFAS based on predefined traits. Substances which meet 

the OECD’s definition of PFAS but that 

would not be considered PFAS under 

this rule do not share properties with 

substances of concern to EPA (i.e., 

PFOA, PFOS, and GenX). As noted 

previously, EPA is defining PFAS for 

this rule to focus on reporting that is 

necessary under TSCA section 8(a)(7), 

while reducing unnecessary or 

duplicative reporting pursuant to EPA’s 

obligations under TSCA section 

8(a)(5)(A). 

Additionally, while the OECD 

definition of PFAS is broader than other 

entities’ definitions of PFAS, EPA is 

aware of some TSCA chemical 

substances which would meet this rule’s 

definition of PFAS but not OECD’s. In 

comparing the universe of PFAS that 

would be subject to EPA’s proposed 

definition and those substances 

captured by OECD’s definition, EPA 

determined that some substances with 

halogens (e.g., iodine, chlorine, 

bromine) on the same carbon as the CF 

or CF2 moiety would be in scope of 

EPA’s proposed definition but not 

OECD’s. Examples of substances which 

are considered PFAS under this rule’s 

definition but not OECD’s definition 

include 1-chloro-1,1,2,2- 

tetrafluoroethane (CASRN 354–25–6) or 

1,2-dichloro-1,1,2,2-tetrafluoroethane 

(CASRN 76–14–2). Because all 

substances which were captured by the 

proposed definition are still captured in 

this final rule, EPA points out that 

adopting the OECD definition would 

still have excluded some substances that 

are captured by this rule’s definition. 

Many commenters also suggested that 

trifluoroacetyl fluoride (TFA; CASRN 

354–34–7) should be included within 

the scope of this rule. Under this rule’s 

definition of PFAS, TFA is not within 

scope. EPA believes TFA does not meet 

the threshold for reporting under TSCA 

section 8(a)(7), as it is a short-chain 

molecule (C2) with only one terminal 

-CF3, and no other fluorine atom, unlike 

substances such as PFOA, PFOS, and 

GenX. TFA is naturally occurring in 

some instances or is produced as an 

environmental degradant of many other 

substances, especially those with only 

one terminal carbon (-CF3) (Refs. 23, 24, 

and 25). EPA understands that the 

manufacture of TFA would not always 

be considered ‘‘manufactured for 

commercial purposes’’ under TSCA, 

such as its production as an 

environmental degradant or its presence 

as a naturally-occurring substance, and 

therefore EPA would not receive any 

TSCA section 8(a)(7) reporting on those 

quantities. Additionally, as EPA has 

noted in responding to a request for 

testing on PFAS, TFA is ‘‘a well-studied 

substance’’ with ‘‘relatively robust 

toxicity information available’’ (Ref. 25). 

Therefore, EPA believes that reporting 

on TFA under a TSCA section 8(a) rule 

(i.e., one in which the scope is limited 

to those substances manufactured for 

commercial purposes and does not 

include environmental degradants) is 

not warranted as such requirements 

would be ‘‘unnecessary’’ and 


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‘‘duplicative’’ under TSCA section 

8(a)(5)(A). 

EPA also disagrees with commenters 

who expressed that the scope of 

substances reportable under this rule 

should be a discrete list and not a 

structural definition. EPA points out 

that other TSCA requirements have 

relied on a structural definition when 

appropriate (e.g., the LCPFAC SNUR 

defines covered substances using a 

structural definition (40 CFR 721.10536) 

(Ref. 7), and the polymer exemption rule 

for new chemical pre-manufacture 

notices (PMNs) defines covered PFAS 

polymers using structural definitions 

(40 CFR 723.250). As some commenters 

pointed out, reporting exemptions for 

both existing chemicals (e.g., certain 

byproduct exemptions in the CDR rule) 

and new chemicals (e.g., byproducts 

and impurities not listed on the 

Inventory) mean that EPA may be 

unaware of some substances which meet 

this definition of PFAS, and which 

would also meet the TSCA definition of 

‘‘chemical substance.’’ Therefore, EPA 

has chosen to define the scope of 

covered substances for the purpose of 

this rule using a structural definition 

and not inadvertently limit the scope of 

reporting to a discrete list. 

B. What is the inclusion for articles? 

1. Summary of Public Input 

Several commenters provided 

feedback on the inclusion of articles 

(whether imported or domestically 

produced) in the proposed reporting 

requirements. 

Commenters who expressed support 

for the inclusion of articles in the 

proposed reporting requirements 

provided the following rationales: 

• It is necessary that EPA include 

articles in the scope of reporting 

requirements to better understand 

where PFAS are used in products and 

the extent of human exposure. 

Additionally, EPA has recognized that 

PFAS in articles can be released during 

use and disposal, and therefore it is 

necessary for EPA to gather this 

information. 

• Information on PFAS-containing 

articles is critical to states that are 

beginning to regulate PFAS-containing 

items. 

• Even if there are data gaps related 

to the presence of PFAS in articles, EPA 

would benefit from knowing the 

existence of these gaps, and therefore, 

EPA should move forward with 

requiring reporting on articles. 

• Congress has authorized inclusion 

of articles in the reporting requirements; 

reporting of ‘‘known or reasonably 

ascertainable information’’ is not an 

excessive burden. Commenters argued 

that excluding articles from the scope of 

the final rule would be inconsistent 

with Congressional intent. 

• The definition of ‘‘chemical 

substance’’ under TSCA is not 

incompatible with the inclusion of 

articles. Further, in other sections of 

TSCA, Congress specified distinct 

requirements for chemical substances 

depending on their presence in articles, 

though it did not do so in TSCA section 

8(a)(7). 

Commenters who suggested that EPA 

exempt articles from the proposed 

reporting requirements provided the 

following rationales: 

• The proposed requirements are at 

odds with regulatory practices; 

historically, EPA has not included 

articles in reporting requirements. 

Additionally, CDR does not include 

reporting on imported articles, and 

some commenters stated that EPA 

should be consistent with those 

requirements. Some commenters 

suggested that the reasons EPA has 

provided in the past for certain CDR 

exemptions, including imported 

articles, are relevant here (i.e., the 

potential for exposure to chemicals 

contained in articles is ‘‘limited’’) and 

encouraged EPA to incorporate an 

imported article exemption under this 

rule. Several of these comments also 

mentioned previous EPA actions, such 

as the TSCA Fees Rule and the phenol, 

isopropylated phosphate (3:1) (PIP (3:1)) 

rule, in which EPA initially aimed to 

include articles but eventually changed 

course due to ‘‘workability’’ issues of 

including articles (Refs. 26 and 27). 

• EPA did not provide sufficient 

justification in the proposed rule for 

requiring article reporting, and there is 

no mandate in the FY 2020 NDAA for 

inclusion of articles. Commenters 

claimed that EPA underestimated or 

failed to account for the burden this 

reporting will have on article importers, 

and EPA is unable to accurately 

estimate how many importers this 

proposed rule would affect. 

• Under TSCA, the definition of 

‘‘chemical substance’’ has not been 

interpreted to include articles which 

contain the chemical substance. 

Commenters argue that TSCA section 8 

implementing regulations also 

distinguish ‘‘articles’’ from ‘‘chemical 

substances.’’ 

• Requiring reporting on articles 

would place undue burden on industry 

and for manufacturers or importers to 

obtain the information EPA seeks is very 

difficult given the absence of historical 

PFAS reporting requirements. 

Commenters claimed that there will be 

significant data gaps if EPA requires 

article information, and that EPA will 

not be able to obtain the information it 

seeks. Additionally, reporting on 

articles going back ten years is 

impractical. 

• EPA has acknowledged that article 

manufacturers and importers likely will 

not have the information EPA seeks, and 

therefore, manufacturers and importers 

should be exempt. These commenters 

also cite their foreign suppliers’ 

confidentiality or trade secret claims 

over their products and indicate that it 

is unlikely their suppliers will divulge 

the information necessary to comply 

with this rule. 

• Supply chains are too broad and 

requiring articles reporting will result in 

duplicative information, especially for 

more complex articles or finished 

products. 

Neutral comments suggested that if 

EPA is going to require reporting on 

articles, they should require reporting 

for domestic article manufacturers only 

and not article importers, and that even 

beyond this rule, EPA should fully 

consider the complexities associated 

with collecting data on articles under 

TSCA. One commenter stated that EPA 

should consider focusing its reporting 

requirements on articles with the 

greatest potential for human exposure. 

The commenter offered as an example 

the differences between articles 

containing PFAS on its surface due to 

the properties that PFAS would impart 

on the product (such as carpets or 

cookware) and articles containing PFAS 

within resins of multi-component parts. 

The commenter suggested that EPA 

exclude articles containing PFAS unless 

the PFAS was intentionally added to the 

article due to properties imparted on the 

article. 

2. EPA’s Response 

EPA appreciates the broad interest in 

the general topic of requiring reporting 

on PFAS within articles (either 

imported articles or articles that are 

domestically produced). This topic was 

also discussed at length during the 

SBAR Panel, and EPA considered all 

public input on the proposed inclusion 

of PFAS-containing articles in this rule. 

EPA is finalizing the requirement to 

include PFAS-containing articles within 

the scope of this rule, to the extent that 

the manufacturer (including importer) 

of PFAS within articles knows or can 

reasonably ascertain the requested 

information. EPA disagrees with 

commenters who stated that the Agency 

does not have the authority to collect 

information on PFAS-containing articles 

given the language in the FY 2020 

NDAA. While the FY 2020 NDAA did 

not explicitly direct EPA to collect data 


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on articles containing PFAS, the FY 

2020 NDAA also did not explicitly 

prevent EPA from collecting 

information on PFAS-containing 

articles. Further, EPA notes that it is 

within the Agency’s authority to collect 

information on chemical substances 

which are manufactured or imported 

through articles. Thus, the FY 2020 

NDAA’s direction to EPA to require data 

from PFAS manufacturers necessarily 

includes those PFAS manufactured 

(including imported) within articles. 

Although EPA has not typically 

included articles in some other TSCA 

section 8 reporting rules, the Agency 

both has the authority and has 

previously done so. Other TSCA rules, 

including other TSCA section 8 

reporting rules (such as the Preliminary 

Assessment Information Reporting rule 

under TSCA section 8(a) (40 CFR part 

712) and the TSCA section 8(d) Health 

and Safety Data Reporting rule (40 CFR 

part 716) include reporting on articles as 

needed for EPA to fulfill its 

responsibilities under TSCA. 

Additionally, EPA points out that the 

TSCA Fees and PIP 3:1 rules (Refs. 26 

and 27) are authorized under separate 

sections of TSCA. This PFAS reporting 

rule was proposed and required under 

TSCA section 8(a), which authorizes 

EPA to require reporting and 

recordkeeping requirements of 

manufacturers and/or processors, to the 

extent such information is known to or 

reasonably ascertainable by the reporter. 

The requirements and compliance 

standards of the PIP 3:1 (use in article 

prohibition) (Ref. 27) and Fees (selfidentification of manufacture) rules 

were different (Ref. 26). 

EPA disagrees with the commenters 

that under TSCA, the definition of 

‘chemical substance’ ‘‘cannot be and has 

never been interpreted to include 

articles that contain the regulated 

chemical substance.’’ TSCA section 3(2) 

does not define ‘‘chemical substance’’ to 

exclude articles. Generally speaking, 

articles are manufactured goods or 

finished products—and the chemicals in 

them are subject to TSCA. The law is 

clear that when a chemical substance is 

manufactured (including imported into 

the United States) or is distributed or 

processed in the United States— 

whether in bulk form or in an article— 

it can be subject to regulation under 

TSCA. As such, EPA can and has 

imposed regulatory requirements on 

chemical substances in articles under 

TSCA. Further, no TSCA section 8 

regulations exclude articles from the 

definition of ‘‘chemical substances.’’ 

While implementing regulations for 

other TSCA section 8 rules may exempt 

reporting for activities related to a 

covered chemical substance in an article 

(e.g., general reporting and 

recordkeeping provisions for TSCA 

section 8(a) information-gathering rules 

(40 CFR part 704) or the Chemical Data 

Reporting rule (40 CFR part 711)), there 

is no definitional distinction for a 

chemical substance depending on 

whether it is incorporated into an 

article; nothing says that an ‘‘article’’ is 

exclusive or distinct from a ‘‘chemical 

substance.’’ While the CDR rule has 

exempted the import of articles from 

reporting, the domestic manufacture of 

a chemical substance within an article 

is still subject to CDR. Further, EPA 

points out that the introductory 

paragraph of 40 CFR 704.5 for 

exemptions states this section is 

superseded by any TSCA section 8(a) 

rule that adds to, removes, or revises the 

exemptions described in this section. 

Thus, the commenters’ reliance on 

precedent under 40 CFR part 704 fails 

to acknowledge that EPA has long 

allowed for different exemptions (or 

lack thereof) to apply under different 

TSCA section 8(a) rules as appropriate. 

EPA also disagrees with commenters’ 

statements that reporting on articles 

would place undue burden on industry. 

EPA points out that the reporting 

standard of TSCA section 8(a) rules is 

limited to information which is known 

to or reasonably ascertainable by the 

manufacturer. Thus, if requested 

information is beyond that scope of 

known or reasonably ascertainable, the 

reporting entity would not be required 

to submit anything beyond indicating 

that such information is not known or 

reasonably ascertainable to them. In 

other words, this reporting standard is 

not a testing requirement; rather it asks 

reporters to share with EPA the 

information they already have (or can 

reasonably determine) on their 

manufactured and imported PFAS. 

Regarding comments on the lookback 

period for article importers, EPA points 

out that the lookback period proposed is 

consistent with Congress’s direction to 

EPA in TSCA section 8(a)(7). EPA is not 

changing the proposed requirement to 

provide any known or reasonably 

ascertainable information for the period 

beginning in 2011. 

Regarding comments stating that 

requiring reporting on articles may 

result in duplicative information for 

complex articles or products that are reimported, EPA disagrees that the 

information reported will result in 

duplicative information, especially 

given the reporting standard applicable 

to this rule. EPA acknowledges that 

some supply chains of manufacturers 

reporting under this rule are complex. 

However, EPA believes that information 

known to or reasonably ascertainable by 

an article manufacturer at the first 

instance the PFAS is imported into the 

United States is likely different than the 

scope of information known to an article 

importer farther down the supply chain 

who may re-import that PFAS later, as 

the article is incorporated into more 

complex articles or products. For 

instance, the person who imports a 

PFAS within an article in the first 

instance may have different worker 

exposure information to report than a 

person who may later re-import that 

PFAS-containing article as part of a 

more complex product. In another 

example, information related to the 

known industrial or consumer uses of a 

PFAS within an article may be clearer 

to the person who re-imports a PFAS 

within a larger complex product than it 

is to the person who first manufactured 

the PFAS within the article. Thus, EPA 

does not believe that the information 

requested of PFAS article manufacturers 

would be duplicative, given the 

different steps of a supply chain and 

manufacturing processes, and is 

requiring all PFAS-containing article 

manufacturers to report the requested 

data to EPA to the extent it is known or 

reasonably ascertainable. EPA also 

believes that applying the reporting 

requirements each time a PFAS is 

imported into the United States is 

consistent with TSCA’s definition of 

manufacturing under TSCA section 3(9) 

(which means ‘‘to import into the 

customs territory of the United States 

(as defined in general note 2 of the 

Harmonized Tariff Schedules of the 

United States), produce, or 

manufacture’’) and the directive under 

TSCA section 8(a)(7). EPA also believes 

that if a PFAS is imported, exported, 

then re-imported, limiting the scope of 

reporting to just one instance of 

importation into the United States may 

result in certain burden on 

manufacturers within the supply chain 

who need to further communicate with 

each other to determine whether a PFAS 

within an article has already been 

reported and who is responsible for 

reporting. Further, with respect to 

comments claiming that the inclusion of 

articles will necessarily result in 

significant data gaps, EPA respectfully 

points out that there is no current 

database with comparable information 

on PFAS in commerce, including within 

articles, over the reporting timeframe. 

EPA cannot make an assessment of 

potential PFAS data gaps without 

considering all reasonably available 

information. Additionally, as noted by 

other commenters, EPA would benefit 


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from better characterizing any data gaps 

after receipt of all reasonably known 

information. 

EPA disagrees with commenters’ 

suggestions to limit the scope of 

reporting on PFAS in articles by 

extending reporting requirements to 

only those articles ‘‘with the greatest 

exposure potential.’’ For the purpose of 

a TSCA section 8 information reporting 

rule, there is no requirement for EPA to 

determine which substances or types of 

articles may pose greater exposure 

potential, unlike some other sections of 

TSCA (e.g., TSCA section 6 Significant 

New Use Rules). This TSCA section 

8(a)(7) rule in particular aims to provide 

EPA with a greater understanding of the 

scope of existing information of PFAS 

within the supply chain and the 

quantities and uses of commercially 

manufactured PFAS, which may 

include PFAS manufactured or 

imported within a variety of articles or 

products. 

Finally, EPA took appropriate and 

necessary steps to consult with the 

public and consider stakeholder input 

on the proposed rule, including 

reporting on PFAS-containing articles. 

These steps included convening an 

SBAR Panel and meeting with 

stakeholders to discuss the proposed 

rule and potential reporting obligations. 

EPA has considered all input for this 

rule, including the complexity of 

different supply chains with respect to 

collecting data on articles. While EPA 

was not able to estimate the burden on 

article importers given the data 

limitations at the time of the proposed 

rule’s publication, the Agency has since 

been able to provide such estimates, 

including input from public 

commenters, peer-reviewed journals, 

other government datasets, and input 

from the SBAR Panel. EPA has now 

remedied this omission in the Economic 

Analysis. 

C. What are the exclusion of processors 

from rule? 

1. Summary of Public Input 

EPA received comments both in 

support of and in opposition to the 

addition of processors to the proposed 

rule. Ten commenters stated that EPA 

should expand the rule beyond 

manufacturers (including importers) to 

cover all facilities processing PFAS. 

Two of these commenters expressed that 

processors are often in the best position 

to provide the information required 

under TSCA section 8(a). Several 

commenters emphasized the importance 

of collecting information on the full life 

cycle of PFAS, including from 

processing operations. Some 

commenters were concerned with a 

potential data gap of PFAS exposures if 

processors are omitted from the final 

rule. Another commenter highlighted 

the importance of tracking the PFAS 

solid waste stream to enhance 

understanding of health risks associated 

with PFAS and to inform other actions 

under environmental regulations such 

as the Safe Drinking Water Act (SDWA) 

and Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA). Many commenters in 

support of adding processors also stated 

that EPA has the authority to require 

reporting from processors, citing both 

the FY 2020 NDAA and TSCA section 

8(a)(1). 

Four commenters indicated that the 

Congress did not intend for the 

proposed rule to include processors and 

that EPA should not require them to 

report. Two of these commenters 

referred to the FY 2020 NDAA section 

7351 language stating that the Act does 

not identify manufacturers that process 

PFAS substances as entities that would 

be subject to the rule. Commenters in 

opposition to adding processors also 

claimed that EPA would be creating 

confusion and the potential for 

duplicative reporting. One commenter 

urged EPA to clarify in the final rule 

that reporting is limited to only the 

initial importers of PFAS-containing 

products and not any downstream 

processors or users. Commenters also 

said that such reporting would create 

unnecessary burden for both EPA and 

processors. 

2. EPA’s Response 

EPA appreciates commenters’ 

perspectives on extending reporting 

requirements to processors for this rule 

under TSCA section 8(a)(7). However, 

the Agency’s reading of the text in 

TSCA section 8(a)(7) and the FY 2020 

NDAA’s legislative history conclude 

that the intended scope of this rule is to 

only require reporting from 

manufacturers (including importers), 

distinct from processors. EPA is 

clarifying that entities who solely 

process, distribute, and/or use PFAS, 

and do not manufacture (including 

import) PFAS for a commercial purpose, 

are not required to report under this 

rule. 

As some commenters noted, the 

Agency would have the authority to 

promulgate such a rule for processors 

under TSCA section 8(a)(1). However, 

this rule is being promulgated under 

TSCA section 8(a)(7). EPA also notes 

that the exclusion of processors from the 

scope of this rule does not preclude any 

potential future rulemaking under TSCA 

section 8(a)(1), should the Agency 

determine such data are needed. EPA 

will review the data submitted by 

manufacturers under this rule and 

reserves the right to promulgate a rule 

under TSCA section 8(a)(1) to capture 

information from PFAS processors if 

appropriate. EPA disagrees with 

commenters who noted that including 

processors in the scope of this rule 

would lead to confusion and duplicative 

reporting. EPA points out that other 

TSCA section 8(a) rules have included 

processors, such as the nanoscale 

materials reporting rule (40 CFR 

740.20). 

D. What were the small business 

considerations? 

1. Summary of Public Input 

Many commenters opined on the 

inclusion of small businesses, including 

small manufacturers, under the 

proposed rule. Several commenters 

stated that EPA should exempt small 

businesses from reporting under the 

proposed rule. Some of these 

commenters said that small businesses 

are not likely to provide useful 

information and will be 

disproportionately affected by the rule 

(including potentially being forced out 

of business) because fewer resources are 

available to them. Others expressed that 

they thought EPA had not evaluated 

whether small businesses would 

actually contribute meaningful data to 

EPA as a result of the rule. 

Four commenters disagreed with 

EPA’s position that the FY 2020 NDAA 

authorizes data collection from all 

manufacturers, including small 

manufacturers. Two of these 

commenters felt that, by not providing 

relief for small manufacturers, EPA did 

not appropriately apply TSCA section 

8(a)(5) requirements. Some commenters 

referred to TSCA section 8(a)(1), which 

they state excludes small manufacturers 

from reporting rules. Another 

commenter stated that EPA needs to 

consider the historical lack of TSCA 

section 8 reporting requirements on 

small manufacturers or article 

importers, including from CDR. 

Other commenters said that EPA 

should collect the information required 

under the proposed rule from all 

businesses regardless of size. While one 

commenter acknowledged that the rule 

could be burdensome for small entities, 

they also said that the health risks 

associated with PFAS are significant 

and warrant the data collection from 

small businesses. Another commenter 

described EPA’s definition of small 

manufacturer under TSCA section 8 as 

‘‘expansive’’ and noted that the existing 

‘‘small manufacturer’’ definition would 


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result in omitting reporting from 

significant PFAS manufacturing and 

importing activities such that it would 

undermine this data collection effort. 

One commenter stated that EPA could 

help small businesses comply with the 

proposed rule in lieu of a small 

manufacturer exemption by extending 

other reporting exemptions to them, 

including R&D substances, non-isolated 

intermediates, impurities, byproducts, 

and articles, as well as a minimum 

reporting threshold. 

2. EPA’s Response 

EPA disagrees with commenters’ 

positions that a broad small business or 

a small manufacturer exemption is 

appropriate for this rule. EPA 

appreciates that small businesses, 

especially those which have not 

previously reported under CDR or other 

TSCA section 8(a) rules, may not have 

the same resources that are available to 

large companies. This feedback was also 

voiced through the rule’s SBAR Panel, 

and EPA is greatly appreciative of the 

input related to small businesses’ 

resources and ability to respond to the 

rule. To that end, EPA has modified the 

proposed rule to include options that 

provide some relief to all manufacturers, 

including small entities. Specifically, 

article importers and manufacturers of 

R&D substances in quantities below 10 

kilograms per year will have the option 

to submit more streamlined reporting 

forms than the longer, standard form for 

all other PFAS manufacturers. 

Additionally, EPA is extending the 

deadline for reporting forms by at least 

six months from what was proposed, so 

that all entities, including small entities, 

have 18 months from the effective date 

of this rule to submit the requested 

information. For small manufacturers 

(as defined at 40 CFR 704.3) whose 

reporting obligations under this rule are 

exclusively from article imports, EPA is 

further extending the deadline for 

reporting forms by an additional six 

months. Thus, small article importers 

have 24 months from the effective date 

of this rule to submit the requested 

information. 

In response to commenters who refer 

to TSCA section 8(a)(1) in their support 

of an exemption for small 

manufacturers, EPA respectfully points 

out that this is a rule authorized under 

TSCA section 8(a)(7), not under TSCA 

section 8(a)(1). While Congress 

explicitly carved out potential 

exemptions for small manufacturers and 

small processors for rules implemented 

under TSCA section 8(a)(1) for 

chemicals not subject to certain TSCA 

actions, Congress chose not to do so in 

the text of TSCA section 8(a)(7). EPA 

considered the provisions at TSCA 

section 8(a)(5) to limit reporting 

requirements for small manufacturers 

and determined that reporting from 

small manufacturers would be 

appropriate under TSCA section 

8(a)(5)(A) through (C). The information 

requested under this rule is not 

unnecessary nor duplicative due, in 

part, to exemptions in other TSCA 

reporting rules. Additionally, a broad 

exemption for all entities deemed a 

‘‘small manufacturer’’ would not enable 

EPA to fulfill the express requirements 

of the NDAA to require ‘‘each person’’ 

to report their PFAS manufacturing 

activities to the extent they know or can 

reasonably ascertain. Regarding the 

provision to minimize the cost of 

compliance on small manufacturers, 

EPA has identified regulatory 

alternatives to the proposed rule that 

reduce compliance costs without a 

complete exemption. Finally, based on 

public comments and input from the 

SBAR Panel, EPA believes that small 

manufacturers are likely to have 

information regarding commercially 

manufactured PFAS, which is relevant 

to the effective implementation of 

TSCA. 

E. What is the concern regarding a lack 

of common TSCA reporting exemptions 

or reporting threshold? 

1. Summary of Public Input 

Many commenters opined on the 

proposed rule’s lack of common TSCA 

reporting exemptions and a reporting 

threshold. Several commenters added 

that incorporating exemptions and/or a 

reporting threshold would make the 

proposed rule consistent with other 

TSCA rules such as CDR, Fees, PAIR, 

and PMN reporting (Refs. 20, 26, and 

27). Commenters cited potential 

compliance challenges and reporting 

burden as the rationale for such 

exemptions, as they stated that the work 

involved in identifying, tracing, and 

reporting under the proposed rule is 

significantly increased without 

exemptions. Other commenters said that 

the lack of exemptions would 

significantly increase the number of 

substances for which reporting must 

occur as opposed to the 1,364 PFAS 

estimated in the proposed rule, as those 

only reflected those PFAS on the 

Inventory or subject to an LVE, yet those 

sources exempt several types of 

substances (e.g., impurities, byproducts, 

R&D substances). Another commenter 

said that these types of substances are 

not likely to result in exposure to 

humans or the environment, and that 

EPA has not articulated what the benefit 

of the additional data would be. 

On the other hand, several 

commenters supported implementation 

of the proposed rule without any 

exemptions. They said that Congress 

intended for each person who 

manufactures a PFAS to be subject to 

the rule, without exemptions, and that 

incorporating exemptions would not be 

consistent with EPA’s past approach for 

PFAS. Some commenters also pointed 

out the differences between the 

objectives of CDR and this PFAS 

reporting rule, stating that CDR’s intent 

is to obtain initial screening information 

on a broad universe of chemicals, while 

this rule’s aim is to collect information 

specifically on PFAS. 

2. EPA’s Response 

EPA appreciates the input from 

commenters on the impacts of not 

incorporating certain reporting 

exemptions or thresholds. EPA 

appreciates the support from 

commenters who supported 

promulgating the final rule without 

exemption and, after reviewing public 

input, has decided to finalize that aspect 

of the proposed rule. 

EPA disagrees with commenters’ 

requests to include many of the 

reporting exemptions found in other 

TSCA rules such as in PMN reporting 

and the Fees Rule (Refs. 20 and 26). EPA 

points out that, unlike the Fees Rule, the 

scope of this rule is information which 

is known to or reasonably ascertainable 

by the manufacturer (Ref. 26). 

While this rule uses the same 

reporting standard as CDR and other 

TSCA section 8(a) rules, this rule is 

focused on improving EPA’s knowledge 

of commercially manufactured PFAS 

and their uses, which includes 

chemicals of concern to human health 

and the environment. Therefore, EPA 

does not believe many of the same 

reporting exemptions used in other 

TSCA rules are warranted. As directed 

by the statute, EPA is requesting 

information on PFAS manufactured for 

a commercial purpose to the extent such 

information is known or reasonably 

ascertainable to the manufacturer. EPA 

also points out that, whether types of 

substances (such as non-isolated 

intermediates, impurities, or articles) 

are likely to result in human or 

environmental exposures is not a 

threshold that EPA needs to satisfy for 

requiring reporting on those substances 

under TSCA section 8(a)(7). EPA aims to 

better understand the scope of existing 

knowledge of the universe of 

historically manufactured PFAS and 

implementing certain exemptions may 

inadvertently lead to the omission of 

information known to or reasonably 

ascertainable to some manufacturers. 


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The information EPA receives through 

this rule will refine the Agency’s 

understanding of certain exposurerelated data of PFAS manufactured. If 

certain substances have not resulted in 

significant human and environmental 

exposures, then that would be reflected 

in the submitted information. 

EPA appreciates the public input on 

the proposed rule’s burden analysis, 

including additional information 

received during the proposed rule’s 

comment period, the SBAR Panel, and 

the IRFA comment period. EPA has 

refined its economic analysis, including 

the estimated scope of covered 

substances and associated burden of 

determining whether reporting is 

required. Regarding commenters’ claims 

that the estimated scope of covered 

substances may be significantly greater 

than estimated without certain 

exemptions, EPA points out that the 

exact challenge articulated by 

commenters justifies the lack of 

exemptions in this rule: the fact that 

stakeholders have questions 

surrounding the number of covered 

substances under this rule, including as 

impurities, intermediates, or R&D 

substances, reveals the lack of existing 

information of the universe of PFAS in 

commerce. EPA aims to better 

understand what manufacturers know 

or may reasonably ascertain regarding 

manufactured PFAS, and exempting 

substances that were not previously 

reported under other TSCA rules would 

hinder that effort. 

F. What is the application of the 

reporting standard? 

1. Summary of Public Input 

EPA received many comments on the 

reporting standard proposed for this 

rule: information known to or 

reasonably ascertainable by the 

manufacturer. The majority of these 

commenters suggested that EPA revise 

their definition of ‘‘reasonably 

ascertainable’’ to assist businesses with 

compliance. Specifically, these 

commenters voiced concerns over the 

time spent to conduct compliance 

determination activities to satisfy the 

‘‘due diligence’’ requirement of the 

reporting standard for many substances 

and products, and for which they do not 

anticipate information being readily 

available even after an extensive search. 

Commenters claimed that, for 

substances which have been historically 

exempt from other TSCA reporting 

requirements (especially imported 

articles), there is likely little if any 

information available, yet entities would 

still be required to perform due 

diligence and demonstrated they have 

examined each imported article. 

However, other commenters largely 

supported EPA’s proposed 

requirements. One commenter suggested 

that ‘‘known and reasonably 

ascertainable’’ should be broadly 

interpreted and that the proposed 

definition of ‘‘known and reasonably 

ascertainable’’ is consistent with 

definitions in TSCA recordkeeping 

regulations and should therefore be 

included, as is, in the final rule. Other 

commenters stated that the requirement 

for manufacturers to assess whether 

they know or can reasonably ascertain 

PFAS’ presence in their articles is a 

modest cost that is outweighed by the 

benefits of the data to EPA and the 

public. 

In addition, there were several 

comments requesting that EPA clarify or 

provide additional guidance on the 

reporting standard for this rule, 

including guidance tailored to article 

importers and what constitutes due 

diligence under this standard. Some 

suggestions included stipulating that the 

scope of a manufacturer’s inquiry 

within their supply chain is limited to 

just immediate suppliers (i.e., no need 

to inquire multiple levels of their 

supply chain), and that if a supplier 

refuses to share information with a 

manufacturer, then the manufacturer 

need not inquire further and would not 

face EPA enforcement action. Some 

commenters also requested further 

clarification of the proposed 

requirement to submit ‘‘reasonable 

estimates’’ for certain data elements 

where actual data are not available. 

2. EPA’s Response 

EPA appreciates the input from 

commenters and the SBAR Panel related 

to the scope of information that may be 

known to or reasonably ascertainable by 

(KRA) PFAS manufacturers, including 

small article importers. EPA has 

incorporated the feedback into both the 

rule (e.g., providing an option of 

streamlined reporting forms for article 

importers and manufacturers of small 

quantities of R&D substances who 

would not know the downstream 

processing, use, and disposal 

information) and this rule’s 

accompanying guidance and 

instructions on applying the KRA 

standard. 

Regarding manufacturers who have 

concerns over the due diligence 

expected under this rule, including 

those who believe they ultimately will 

not obtain any reportable information, 

EPA clarifies that there is no reporting 

or recordkeeping requirement if an 

entity has no relevant information. This 

rule does not itself require any company 

to maintain information upon which a 

decision not to report is based. 

Consistent with their own business 

practices, companies may elect to retain 

documentation of their conclusion that 

they were not subject to reporting 

requirements. While manufacturers and 

importers are expected to exercise ‘‘due 

diligence’’ in looking for reportable 

PFAS and information, that effort will 

look different for different entities. 

EPA also acknowledges that it may 

not be within the scope of ‘‘reasonably 

ascertainable’’ to survey all articles and 

products, especially for article 

importers. In addition to the existing 

guidance on this reporting standard, 

EPA is providing guidance on this 

reporting standard with respect to 

article importers and other entities who 

may be exempt under other TSCA 

regulations (e.g., manufacturers of small 

quantities of R&D substances). 

Regarding the suggestions that the 

rule should limit the scope of a 

manufacturer’s inquiry of its supplier(s) 

to only information which the supplier 

does not claim as CBI or trade secret, 

EPA is enabling a joint submission 

option within the future reporting tool. 

Similar to one of the joint submission 

options in the CDR tool, a PFAS 

manufacturer whose supplier does not 

volunteer requested information, 

including the specific chemical identity 

of a PFAS imported from the supplier, 

would have the option to complete the 

PFAS reporting form to the extent 

information is known or reasonably 

ascertainable. The manufacturer would 

then initiate an email to its supplier via 

the CDX-based tool and request the 

supplier provide the necessary 

information to EPA, using a secondary 

reporting form, without needing to 

divulge to the reporting entity the 

specific chemical identity of the PFAS 

or the composition of the product. The 

tool will create an electronic record of 

the U.S.-based importer’s attempts to 

contact the supplier and request 

information. Further, if the immediate 

supplier does not know the information, 

they may continue to send an email via 

the reporting tool to their own 

suppliers, in an effort to secure the 

requested information. 

G. What are the concerns regarding 

potential duplicative reporting? 

1. Summary of Public Input 

EPA received comments on potential 

duplicative reporting under the 

proposed rule and NODA public 

comment periods. The majority of 

commenters shared the sentiment that 

the proposed reporting requirements 


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would result in duplicative reporting 

that is contrary to TSCA section 

8(a)(5)(A), which requires EPA to avoid, 

to the extent feasible, reporting which is 

unnecessary or duplicative. Most of 

these commenters shared the opinion 

that some information required to be 

reported under the proposed rule is 

extremely similar to, if not the same as, 

information required under the CDR 

rule. One commenter, however, shared 

a contrasting opinion that EPA should 

not exclude information previously 

reported under CDR requirements on 

the grounds that omitting that 

information would compromise EPA’s 

ability to collect and aggregate PFAS 

data pursuant to TSCA section 8(a)(7). 

The commenters who stated that the 

requirements in the proposed rule 

consist of duplicative reporting 

primarily cited reporting requirements 

under the CDR rule as justification for 

their position. Multiple commenters 

also cited studies submitted as 

unpublished health and safety studies 

under TSCA section 8(d) and the 

substantial risk notification 

requirements under TSCA section 8(e). 

One commenter claimed that EPA is 

likely already in possession of a 

considerable amount of PFAS 

information from studies submitted to 

EPA under new chemicals reporting 

(i.e., PMN and LVE applications) and 

TSCA section 8(e) reporting. A few 

commenters also suggested that 

companies should not be required to 

collect and repeat data for past nonprincipal reporting years. Other 

commenters specified that EPA should 

limit reporting of information 

concerning environmental or health 

effects by excluding information that is 

publicly available, such as information 

published in scientific journals, as 

requiring reporting of this information 

would be unnecessary and duplicative. 

Multiple commenters claimed that 

including articles in the required 

reporting would substantially increase 

duplicative reporting due to the number 

of entities an article may pass through, 

who would then all be required to 

report information on that chemical. 

Two commenters raised the issue of 

articles which are exported from and 

then reimported into the U.S. and 

asserted that the reporting of reimported 

articles would be considered 

duplicative reporting. To remedy this 

situation, a commenter suggested that 

EPA require reporting at the level of 

manufacturing the PFAS itself, and 

possibly the first supplier that 

incorporates a PFAS, but no further. 

2. EPA’s Response 

EPA acknowledges that some of the 

data elements may overlap with the data 

required under the 2020 CDR cycle but 

disagrees that the scope of such overlap 

is significant. There are several 

differences between the CDR rule and 

this rule which limit the scope of any 

potential overlaps between the datasets. 

First, CDR includes several reporting 

exemptions and a reporting threshold 

based on production volume, which are 

not included in this rule: imported 

articles, certain byproducts, nonisolated intermediates, small quantities 

of R&D chemicals, small manufacturers, 

and a minimum production volume 

reporting threshold of 25,000 lbs/year 

(or 2,500 lbs/year for substances subject 

to certain TSCA actions). Therefore, 

PFAS reporters with activities that are 

exempt in CDR or who manufacture 

PFAS below the CDR threshold will not 

have reported such information to CDR 

before and would not be considered 

‘‘duplicative’’ here. Further, CDR 

reporters may have excluded quantities 

that would be reportable under this rule, 

based on certain CDR exemptions, and 

therefore the information they 

previously submitted to CDR would not 

be considered duplicative and would 

not be responsive to this rule. Secondly, 

the PFAS that have been reported to 

CDR are a subset of the scope of PFAS 

for this rule. The scope of CDR chemical 

substances is limited to those on the 

Inventory and excludes polymers. The 

scope of this reporting rule includes any 

chemical substance meeting the rule’s 

structural definition, which is not 

limited to those on the Inventory (e.g., 

LVEs), and includes any fluoropolymers 

that meet the structural definition. 

Finally, the years for which certain 

required data elements may have been 

reported to CDR differ. Some of the 

information described earlier in this 

unit is reported differently for the 

principal reporting year compared to the 

other three years within the four-year 

CDR period. For instance, the 

production volumes for domestic 

manufacture and import are combined 

for any non-principal reporting year. 

Further, prior CDR cycles had different 

required information. Therefore, the 

extent of potentially ‘‘duplicative’’ 

reporting between CDR and this rule is 

limited, especially when considering 

each year for which reporting is 

required under this rule. 

EPA is finalizing the proposal to not 

require resubmission of information that 

has been reported to CDR, unless that 

information did not reflect all activities 

or quantities for which reporting is 

required under this rule. EPA disagrees 

with the commenter who suggested that 

EPA should not exclude information 

previously reported under CDR. Such 

information could be duplicative and 

therefore EPA is limiting that reporting 

under TSCA section 8(a)(5)(A). 

EPA also appreciates the commenters’ 

input regarding information previously 

submitted via TSCA section 8(e) 

reporting. EPA agrees that substantial 

risk notification requirements submitted 

to EPA under TSCA section 8(e) could 

be considered ‘‘information concerning 

the environmental or health effects’’ of 

a PFAS. To that end, EPA is finalizing 

the rule to acknowledge that 

manufacturers who have previously 

submitted substantial risk notifications, 

other unpublished health and safety 

studies under TSCA section 8(d), or 

other relevant information concerning 

environmental or health effects need not 

resubmit the information. However, to 

enable EPA to easily collect those prior 

submissions, the manufacturers must 

indicate the rule or program to which 

they submitted that prior information 

concerning the environmental or health 

effects of that PFAS and the year in 

which it was submitted to EPA. EPA 

also reiterates that manufacturers need 

not submit health and environmental 

effects information that is not in their 

possession or control, but could be 

found from a publicly available source. 

Finally, regarding the comments 

related to whether reporting certain 

imported articles in complex products 

may lead to duplicative reporting: EPA 

disagrees that the information reported 

will result in duplicative information, 

especially given the reporting standard 

applicable to this rule. EPA believes that 

information known to or reasonably 

ascertainable by an article manufacturer 

at the first instance the PFAS is 

imported into the United States is likely 

different than the scope of information 

known to an article importer farther 

down the supply chain who may reimport that PFAS later, as the article is 

incorporated into more complex articles 

or products. EPA also believes that 

applying the reporting requirements 

each time a PFAS is imported into the 

United States is consistent with TSCA’s 

definition of manufacturing and 

directive under TSCA section 8(a)(7). If 

a PFAS is imported, exported, then reimported, then limiting the scope of 

reporting to just one instance of 

importation into the United States may 

result in certain burdens on 

manufacturers within the supply chain 

who need to further communicate with 

each other to determine whether a PFAS 

within an article has already been 

reported and who is responsible for 

reporting. 


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H. What are the concerns regarding the 

lookback period? 

1. Summary of Public Input 

Several commenters stated that 

attempting to obtain or develop the 

required information over a ten-year 

lookback period is not feasible and 

would constitute a significant burden to 

reporters, and they felt that EPA should 

eliminate or shorten the lookback 

period. These commenters suggested 

either setting the lookback period to 

either 3 years, or 5 years to be consistent 

with the CDR recordkeeping 

requirement. Commenters stated that it 

would be difficult or impossible to 

collect the information required due to 

the complexities of their supply chains, 

the turnover rate of foreign suppliers 

especially for fad markets, the lack of 

historical reporting requirements for 

PFAS in products, and the concurrent 

supply chain disruptions rendered by 

the COVID–19 pandemic. Commenters 

also suggested that creating or recreating 

data from the lookback period will 

result in imprecise data. In addition to 

the suggestions to reduce the lookback 

period, some commenters suggested that 

EPA consider implementing a 

‘‘principal reporting year’’ approach as 

used in CDR, in which only production 

volumes are reported for each year, 

while the more detailed data elements 

are reported for only the principal 

reporting year. Other suggestions 

included exempting articles or 

exempting companies that have since 

phased out PFAS by the reporting 

deadline. 

2. EPA’s Response 

EPA disagrees with the commenters 

who have suggested altering the 

lookback period from 2011 to a more 

recent year. The language in TSCA 

section 8(a)(7) directs EPA to 

promulgate a reporting rule for ‘‘each 

person who has manufactured a 

chemical substance that is a [PFAS] in 

any year since January 1, 2011, to 

submit to the Administrator a report 

that includes, for each year since 

January 1, 2011, the information 

described in subparagraphs (A) through 

(G) of paragraph (2).’’ Congress’s 

direction to EPA is clear: the lookback 

period for this reporting rule must begin 

on January 1, 2011. EPA understands 

the extent of information known to or 

reasonably ascertainable by a 

manufacturer may vary for several 

reasons. However, EPA’s obligation 

under TSCA section 8(a)(7) and interest 

in identifying the scope of available and 

existing data on historically 

manufactured PFAS demand that PFAS 

manufacturers conduct their due 

diligence and submit requested 

information to the extent it is known or 

reasonably ascertainable. 

I. What is the submission period 

duration and reporting deadline? 

1. Summary of Public Input 

EPA received significant input on the 

duration of the proposed submission 

period. Many commenters and input 

during the SBAR Panel claimed that the 

proposed rule’s reporting deadline is 

unrealistic, and EPA should allow more 

time for reporting to accomplish the 

required data collection. Commenters 

provided a range of alternatives to 

consider for the reporting deadline, 

from 1.5 years from rule promulgation 

to 5 years from rule promulgation for 

article importers. 

Several commenters provided 

detailed descriptions of the types of 

activities that would need to occur 

during the submission period as 

evidence of why they felt the proposed 

submission period to be inadequate. 

Some commenters raised EPA’s 

experiences with the PIP (3:1) rule as 

justification for a longer time frame for 

extensive PFAS data reporting (Ref. 27). 

Other reasons provided by commenters 

regarding why additional time is needed 

include: time to familiarize themselves 

with the rule; unclear scope of 

requirements in the proposed rule; lack 

of systems in place with which to track 

the data leading to manual collection; 

and lack of ability to outsource the task 

to contractors due to the confidentiality 

concerns. In addition, one commenter 

noted that other jurisdictions have 

delayed the implementation of new 

rules in light of overwhelming burden, 

COVID, and supply chain disruptions. 

EPA also received some comments 

urging the Agency to finalize this aspect 

of the proposed rule and not delay the 

deadline by which PFAS data are 

submitted. Commenters cited the 

pressing need for such data and the 

awareness within the regulated 

community of this rule. 

2. EPA’s Response 

EPA appreciates the significant 

feedback the Agency received from the 

public, including through the SBAR 

Panel, on the duration of the reporting 

submission period. After considering 

input from the commenters and other 

stakeholders, EPA agrees that the 

proposed reporting time frame may not 

be sufficient for identifying, collecting, 

and reporting the scope of information 

requested by this rule. While EPA 

disagrees that the extent of activities 

necessarily requires investigations of the 

supply chain that would take up to five 

years to complete, it is modifying the 

proposal by adding six more months to 

the information collection period ahead 

of the reporting tool opening (for a total 

of one year from the effective date of 

this rule). This one-year information 

collection period will then be followed 

by a six-month reporting submission 

period. Thus, information will be due 

18 months following the effective date 

of this rule for all PFAS manufacturers 

except certain small article importers. 

EPA has provided an additional six 

months for small manufacturers (as 

defined at 40 CFR 704.3) who would 

report exclusively article importers for 

the purposes of this rule. Therefore, 

small article importers have two years 

from the effective date of this final rule 

to report. Thus, information will be due 

24 months following the effective date 

of this rule for small manufacturers (per 

40 CFR 704.3) who are reporting 

exclusively as article importers. EPA 

believes this timeframe will be 

sufficient to allow reporters to 

familiarize themselves with the rule, 

identify PFAS they have produced or 

imported, identify any suppliers or 

other contacts, collect information, and 

submit the information to EPA. The 

additional time will enable reporters to 

thoroughly review their known or 

reasonably ascertainable information 

and provide EPA with the extent of the 

requested information under this 

reporting standard. 

Additionally, as this is a TSCA 

section 8(a) reporting rule, EPA 

disagrees with commenters who request 

additional reporting time by comparing 

this rule to the PIP (3:1) rule or other 

non-section 8 reporting rules (Ref. 27). 

The reporting standard under TSCA 

section 8(a) does not apply to those 

rules, which may require additional 

compliance activities. However, EPA 

agrees with commenters who pointed 

out the distinctions between this rule 

and CDR as a basis for extending the 

reporting period: the CDR rule requires 

only a four-year lookback period, 

includes certain exemptions and 

reporting thresholds, different data 

elements, and is regularly occurring so 

that companies can anticipate reporting. 

Due, in part, to these differences with 

CDR, EPA is extending the information 

collection period ahead of the 

submission period, thereby providing 

reporters with 18 months to submit 

information for this rule (or 24 months 

for small article importers). 

EPA disagrees with commenters who 

have suggested the reporting deadline 

should be sooner than what was 

proposed. EPA appreciates the 

commenters’ interest in reviewing the 

submitted PFAS data as soon as 


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possible, but notes the scope of this rule 

and differences between this rule and 

CDR as factors in allowing the reporting 

community extra time to sufficiently 

review their known or reasonably 

ascertainable information and to submit 

the required data to EPA. 

J. Can joint submissions be allowed? 

1. Summary of Public Input 

Some commenters requested that EPA 

allow joint submissions. They suggested 

it might ease the reporting burden and 

simplify the reporting process while 

still protecting CBI. However, other 

commenters stated that joint 

submissions can still be a substantial 

burden for companies already trying to 

complete their own reporting within a 

prescribed timeframe. Commenters 

urged EPA to carefully consider a 

workable solution to protecting CBI and 

reducing industry burden for 

compliance. In response to the NODA, 

one commenter asked EPA to eliminate 

the requirement for joint submissions in 

response to chemical identity CBI 

concerns. 

2. EPA’s Response 

EPA agrees with the commenters’ 

requests for joint submissions and is 

finalizing this requirement for reporters 

(other than article importers) whose 

suppliers do not wish to disclose 

chemical identity. EPA agrees that such 

an approach would help protect 

suppliers’ CBI while not withholding 

necessary information from EPA related 

to PFAS identity. While this may 

increase burden on upstream 

companies, EPA believes this approach 

will both help downstream 

manufacturing and reporting entities, as 

well as protect CBI if the suppliers do 

not wish to disclose it to their 

customers, including reporting entities. 

K. What are the economic analysis 

considerations? 

1. Summary of Public Input 

Many commenters addressed the 

impact of the proposed rule in general: 

on industry, EPA, and the general 

public. Several commenters provided 

input on the industry burden estimates 

provided in EPA’s draft Economic 

Analysis for the proposed rule, with 

many stating that EPA underestimated 

the cost industry would incur to comply 

with the proposed rule and failed to 

include article importer costs. 

Commenters provided specific feedback 

on EPA’s burden and cost estimates for 

certain activities including rule 

familiarization, CBI substantiation, 

article identification, determination of 

chemical identity, identification of 

byproducts, outreach to suppliers, data 

collection, CDX access and training, 

form completion and recordkeeping. 

Some of these commenters provided 

additional data or factors to consider 

when estimating burden or costs for 

these compliance activities, including 

providing results of their own industry 

surveys. Commenters also provided 

specific feedback on the proposed rule’s 

burden on article importers and stated 

that EPA’s draft burden assessment is 

significantly underestimated. Some 

commenters stated that article importers 

may face substantially more costs than 

domestic producers because they lack 

the knowledge needed for compliance 

yet would still incur costs under the 

reporting standard. Additionally, 

because article importers do not have 

experience with CDR, commenters 

believed their cost would be higher than 

EPA’s draft estimates which used CDR 

to extrapolate burden estimates for this 

rule. 

Some commenters also claimed that 

EPA’s use of CDR burden to derive 

burden estimates under this rule was 

inappropriate due to the differences 

between the two rules. Commenters also 

provided feedback on the estimated 

number of substances subject to 

reporting in the draft Economic 

Analysis and claimed that the draft 

estimates were too low. Some 

commenters pointed out that, because 

the proposed rule does not have the 

same exemptions as CDR nor is limited 

to a discrete list of substances, the 

number of substances subject to 

reporting would be substantially higher 

than the estimates provided in the draft 

Economic Analysis. 

EPA also received comments that the 

proposed rule significantly 

underestimated the universe of small 

entities that would be subject to the 

rule, both due to the lack of estimates 

related to article importers and to the 

extrapolation from CDR data. Some 

commenters described the unique 

difficulties or burdens small businesses 

face when complying with the proposed 

rule compared to larger businesses. 

Commenters stated that EPA cannot 

justify an RFA certification without 

further analysis of the small business 

impacts and requested that EPA 

convene an SBAR Panel under the RFA 

to obtain feedback from small 

businesses potentially affected by the 

rule. 

Some commenters also stated that 

EPA’s draft Economic Analysis 

underestimated burden on the Agency 

itself. Namely, the need to increase CDX 

capacity to handle the number of 

reporting forms and other 

administrative costs of reviewing the 

submitted data are not reflected in the 

draft Economic Analysis. 

Finally, other commenters claimed 

that EPA had not accounted for the 

social and health costs associated with 

PFAS exposure in the burden analysis. 

Commenters added that the public and 

various government entities have 

incurred significant health, social, and 

financial costs due to inadequate 

information related to PFAS, and that 

even an underestimation of industry 

compliance costs for this rule are 

minimal compared to the externalized 

costs that the public and governments 

bear related to PFAS exposure and 

remediation. 

2. EPA’s Response 

EPA appreciates the feedback on the 

draft Economic Analysis and agrees 

with commenters that an SBAR Panel 

was appropriate given the limitations of 

data related to the small entity universe 

at the time of the proposed rule’s 

publication. Accordingly, EPA 

convened an SBAR Panel for this rule in 

April 2022 and completed it in August 

2022. Using feedback from commenters, 

input during the SBAR Panel, and 

additional data made available to EPA 

since the proposed rule’s publication, 

EPA has since accounted for the burden 

that the rule would impose on article 

importers and small entities. The 

burden estimates include the number of 

article importers who will be required to 

report as well as the number of entities 

that will have to assess their product 

lines to determine whether they must 

submit reports. EPA disagrees that the 

article importer compliance 

determination activities are too low. 

EPA recognizes that a range of activities 

may be involved depending on the level 

of experience of the importer. Actual 

costs may vary based on the number of 

articles imported, the complexity of the 

articles, the number of suppliers, and 

the frequency of supplier changes. EPA 

has increased the rule familiarization 

costs as well as included the burden of 

understanding the structural definition 

of PFAS. Readers are referred to EPA’s 

updated Economic Analysis for details 

regarding the assumptions of calculating 

burden and costs for article importers 

and small entities. 

With regards to the use of CDR data, 

EPA acknowledges that CDR data are 

subject to reporting thresholds and that 

the CDR universe does not reflect a 

perfect representation of the likely 

reporting universe of this rule. EPA 

recognizes the limitations of using CDR 

data in estimating the burden, including 

the number of PFAS for which 

companies may ultimately report. 

However, there is no comprehensive 


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database of PFAS manufactured in the 

U.S. that EPA could use to develop 

more precise estimates. The reporting 

requirements of this rule will serve to 

fill this knowledge gap. After 

considering input from the proposed 

rule’s public comments, stakeholders in 

the SBAR Panel, and comments 

received on the IRFA, EPA is continuing 

to rely on the CDR data to extrapolate 

the estimated number of PFAS to be 

reported per firm. EPA acknowledges 

that the number may vary for some 

manufacturers but believes that using 

CDR for such estimates will help 

provide an industry average. 

EPA has updated the Agency costs to 

account for the volume of reports that 

will be submitted. EPA will incur costs 

in administering the final rule 

associated with processing submitted 

reports, analyzing data from the reports, 

maintaining the information technology 

systems that support these activities, 

reviewing CBI claim substantiations, 

and information technology 

infrastructure. 

Finally, with regard to the comments 

that EPA has not accounted for social 

and health costs associated with PFAS, 

EPA points out that this rule is a TSCA 

section 8(a) reporting and recordkeeping 

rule and does not impose any 

restrictions or other chemical 

management requirements. While the 

benefits of this rule include additional 

information related to potential PFAS 

exposure, which will help inform future 

regulatory and research activities, EPA 

cannot quantify those benefits at this 

time, though the Agency discusses them 

qualitatively in the Economic Analysis. 

L. What are the CBI claim submission 

requirements? 

1. Summary of Public Input 

Several commenters submitted 

comments regarding reporting 

requirements in the proposed rule and 

EPA’s intended approach to reviewing 

CBI claims as stated in the NODA. Their 

comments generally fell into two 

categories: (1) Urging EPA to protect CBI 

and simplify electronic reporting to 

allow joint submissions when needed, 

in addition to making substantiation 

procedures for CBI claims more 

simplified, and not allowing reporters 

without knowledge of a specific 

chemical identity to waive a CBI claim 

for that chemical identity; and (2) 

Urging EPA to require valid and wellexplained rationale for any CBI 

exemptions, and generally asking EPA 

to disclose as much information to the 

public as possible. Some commenters 

also cited concerns with the proposed 

rule’s CBI protections as being 

inadequate for R&D activities, including 

those in the defense or national security 

industries. Some commenters requested 

that the Agency allow a ‘‘blanket 

substantiation’’ for all CBI claims so that 

reporters would not be required to 

substantiate each individual CBI claim. 

On the other hand, commenters who 

are supportive of limiting the amount of 

information claimed as CBI (especially 

regarding health and safety studies) 

cited the urgent need for states to 

address their own PFAS exposure and 

contamination issues and the benefit 

that this rule will confer on state 

agencies struggling with inadequate 

PFAS information. These commenters 

encouraged EPA to review claims and 

disclose as much information submitted 

under this rule as possible. 

Commenters during the NODA 

comment period also addressed EPA’s 

proposal to require that any PFAS 

generic name include ‘‘fluor,’’ at 

minimum, and EPA’s proposal to 

determine that failure to stipulate that a 

chemical for which the identity is being 

claimed as CBI is fluorinated would be 

an insufficient claim. Some commenters 

were supportive of such requirements; 

other commenters discouraged EPA 

from implementing this requirement as 

it may create confusion. Finally, 

commenters diverged on EPA’s intent to 

move any PFAS identity to the public 

TSCA Inventory without prior notice if 

it is not claimed as CBI. While some 

commenters supported this approach, 

others described potential 

complications of confidential chemical 

identity protection when multiple 

entities submit reports for the same 

substance, some of whom may not assert 

CBI for the identity, and requested that 

EPA notify all claimants of a potential 

change in CBI status for a chemical 

identity and allow appeal opportunities. 

2. EPA’s Response 

EPA does not believe that an option 

for blanket CBI claims substantiation is 

appropriate for an information 

collection rule such as this one, in 

which several types of information are 

requested. TSCA section 14(c) requires 

substantiation specific to each claim. 

Because the type of information 

requested under this rule varies, a 

blanket substantiation is unlikely to 

address the specific reasons for each 

data element claimed as CBI. The more 

generic a substantiation gets, the less 

support it provides for any specific 

claim. In terms of information 

disclosure, EPA is committed to 

reviewing CBI claims and 

substantiations pursuant to TSCA 

section 14 and implementing 

regulations, and publicly disclosing data 

that are not approved as CBI to the 

extent possible. 

As noted in the preamble of the 

proposed rule, TSCA limits 

confidentiality protections for health 

and safety studies, and information from 

health and safety studies (except to the 

extent such studies or information 

reveals ‘‘information that discloses 

processes used in the manufacturing or 

processing of a chemical substance or 

mixture or, in the case of a mixture, the 

portion of the mixture comprised by any 

of the chemical substances in the 

mixture’’). Submitters asserting a 

confidentiality claim for such 

information in health and safety studies 

are also required to submit a sanitized 

copy of the study, removing only that 

information which is claimed as CBI 

and that discloses the process or portion 

of mixture information described in 

TSCA section 14(b). However, certain 

other information within study reports 

may be claimed as CBI, such as the 

names of lab personnel or the company, 

or other information that is not related 

to health or environmental effects. 

In response to requests for EPA to 

work directly with states on disclosing 

CBI submitted under this rule, EPA 

points out that TSCA section 14(d)(4) 

permits states, tribes, and political subdivisions of states to request access to 

CBI in writing. Under this authority, the 

entity seeking CBI access must show 

that it can continue to protect the 

information as confidential. If a state or 

tribe requests access and that is granted 

per statutory conditions, EPA would 

have an agreement in place laying out 

how the requestor was going to protect 

the information. 

In response to comments on the CBI 

procedures described in the NODA, EPA 

is not requiring article importers to 

assert CBI for the chemical identity and 

will not make public any chemical 

identity based on article importer 

submissions alone (see discussion in 

Unit III.G). Further, EPA acknowledges 

some commenters’ concerns that 

multiple manufacturers may report the 

same PFAS, but not all submitters may 

assert a CBI claim for the PFAS identity. 

EPA will publish a list of Accession 

numbers associated with chemical 

identities that it plans to move to the 

public portion of the Inventory because 

either no chemical identity CBI claim 

was asserted or the claim was denied. 

Publication of these Accession numbers 

will provide entities an opportunity to 

contact EPA with questions or concerns 

before specific chemical identities are 

moved to the public Inventory (see Unit 

III.G for more details on this process). 

Finally, EPA believes that requiring 

‘‘fluor’’ in generic name submissions is 


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consistent with PMN reporting 

requirements which provide that a 

generic name ‘‘should reveal the 

chemical identity of the substance to the 

maximum extent possible’’ (40 CFR 

720.85(a)(3)(i)(B)), and is finalizing this 

requirement as discussed in the NODA 

(Ref. 1). 

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. EPA (2022). TSCA Section 8(a)(7) 

Reporting and Recordkeeping Requirements 

for Perfluoroalkyl and Polyfluoroalkyl 

Substances; Notice of Data Availability and 

Request for Comment (87 FR 72439, 

November 25, 2022 (FRL–7902–04–OCSPP)). 

2. EPA (2023). Economic Analysis for the 

Final TSCA Section 8(a)(7) Reporting and 

Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances. September 2023. 

3. EPA (2023). Research on Per- and 

Polyfluoroalkyl Substances (PFAS). Available 

at https://www.epa.gov/chemical-research/ 

research-and-polyfluoroalkyl-substancespfas. 

4. Agency for Toxic Substances and 

Disease Registry (ATSDR) (2021). 

Toxicological Profile for Perfluoroalkyls. 

Available at https://www.atsdr.cdc.gov/ 

toxprofiles/tp200.pdf [accessed February 10, 

2023]. 

5. EPA (2021). PFAS Strategic Roadmap: 

EPA’s Commitments to Action 2021–2024. 

October 2021. Available at https://

www.epa.gov/system/files/documents/2021- 

10/pfas-roadmap_final-508.pdf. 

6. EPA. CompTox Chemicals Dashboard. 

Available at https://comptox.epa.gov/ 

dashboard/. 

7. EPA (2020) Long-Chain Perfluoroalkyl 

Carboxylate and Perfluoroalkyl Sulfonate 

Chemical Substances; Significant New Use 

Rule (85 FR 45109, June 27, 2020 (FRL– 

10010–44)). 

8. OECD (2021). Reconciling Terminology 

of the Universe of Per- and Polyfluoroalkyl 

Substances: Recommendations and Practical 

Guidance. July 9, 2021. Series on Risk 

Management. No.61. Environment 

Directorate Chemicals and Biotechnology 

Committee. Available at https://

www.oecd.org/officialdocuments/

publicdisplaydocumentpdf/?cote=ENV/CBC/ 

MONO(2021)25&docLanguage=En. 

9. Buck, Robert C., et al. (2021). 

Identification and Classification of 

Commercially Relevant Per- and PolyFluoroalkyl Substances (PFAS). May 14, 

2021. Integrated Environmental Assessment 

and Management, vol. 17, no. 5. Available at 

https://setac.onlinelibrary.wiley.com/doi/ 

full/10.1002/ieam.4450. 

10. Gaines, Linda, et al. (2023). A Proposed 

Approach to Defining Per- and 

Polyfluoroalkyl Substances (PFAS) Based on 

Molecular Structure and Formula. Integrated 

Environmental Assessment and Management. 

Accepted Author Manuscript. https://doi.org/ 

10.1002/ieam.4735. 

11. United Nations Environment 

Programme (UNEP) (2022). Updated 

indicative list of substances covered by the 

listing of perfluorooctanoic acid (PFOA), its 

salts and PFOA-related compounds. March 4, 

2022. Stockholm Convention on Persistent 

Organic Pollutants. Available at https://

chm.pops.int/Portals/0/

download.aspx?d=UNEP-POPS-POPRC.17- 

INF-14-Rev.1.English.PDF. 

12. EPA (2020). Advancing Sustainable 

Materials Management: 2018 Facts and 

Figures Report. December 2020. https://

www.epa.gov/sites/default/files/2021-01/ 

documents/2018_tables_and_figures_dec_

2020_fnl_508.pdf. 

13. EPA (2023). International Agreements 

on Transboundary Shipments of Hazardous 

Waste. https://www.epa.gov/hwgenerators/ 

international-agreements-transboundaryshipments-hazardous-waste. 

14. EPA (2023). Small Entity Compliance 

Guidance for the TSCA PFAS Data Call. 

September 2023. 

15. EPA (2023). Data Elements included in 

the TSCA Section 8(a)(7) Reporting and 

Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances, Final Rule. September 2023. 

16. OECD. OECD Harmonised Templates. 

Available at https://www.oecd.org/ehs/ 

templates/harmonised-templates.htm. 

17. EPA (2023). Addition of Certain PFAS 

to the TRI by the National Defense 

Authorization Act. Available at https://

www.epa.gov/toxics-release-inventory-triprogram/addition-certain-pfas-tri-nationaldefense-authorization-act. 

18. EPA (2023). Greenhouse Gas Reporting 

Program (GHGRP). Available at https://

www.epa.gov/ghgreporting. 

19. EPA (2018). Guidance for Creating 

Generic Names for Confidential Chemical 

Substance Identity Reporting under Toxic 

Substances Control Act. EPA 743B18001. 

June 2018. 

20. EPA (2010) Premanufacture 

Notification Exemption for Polymers; 

Amendment of Polymer Exemption Rule to 

exclude Certain Perfluorinated Polymers (75 

FR 4295, January 27, 2010 (FRL–8805–5)). 

21. EPA (2023). Response to Public 

Comments: TSCA Section 8(a)(7) Reporting 

and Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances. September 2023. 

22. EPA (2022). TSCA Section 8(a)(7) Small 

Business Advocacy Review (SBAR) Panel 

Report. August 2022. 

23. EPA (2022). Initial Regulatory 

Flexibility Analysis and Updated Economic 

Analysis for TSCA Section 8(a)(7) Reporting 

and Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances. November 2022. 

24. EPA (2021). EPA Response to Petition 

on Testing for Certain PFAS. December 2021. 

Available at https://www.epa.gov/system/ 

files/documents/2021-12/pfaspetition

response.pdf. 

25. Frank, Harmut, et al. (2002). 

Trifluoroacetate in ocean waters. 2002. 

Environmental Science & Technology, 36(1), 

12–15. Available at https://doi.org/10.1021/

es0101532. 

26. EPA (2018). Fees for the 

Administration of the Toxic Substances 

Control Act (TSCA) (83 FR 52694, October 

17, 2018 (FRL–9984–41)). 

27. EPA (2022). Regulation of Persistent, 

Bioaccumulative, and Toxic Chemicals 

Under TSCA Section 6(h); Phenol, 

Isopropylated Phosphate (3:1); Further 

Compliance Date Extension (87 FR 12875, 

March 8, 2022 (FRL–6015.6–02–OCSPP)). 

28. EPA (2023). Information Collection 

Request Supporting Statement entitled ‘‘Final 

Rule ICR: Reporting and Recordkeeping 

Requirements for PFAS (RIN 2070–AK67).’’ 

EPA Information Collection Request (ICR) 

No. 2682.02. September 2023. 

29. EPA (2023). Final Regulatory 

Flexibility Analysis and Updated Economic 

Analysis for TSCA Section 8(a)(7) Reporting 

and Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances. September 2023. 

30. EPA. Unfunded Mandates Reform Act 

Statement. PFAS; Reporting and 

Recordkeeping Requirements under the 

Toxic Substances Control Act (TSCA); Final. 

May 2023. 

VI. Statutory and Executive Orders 

Reviews 

Additional information about these 

statutes and Executive orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Orders 12866: Regulatory 

Planning and Review and 14094: 

Modernizing Regulatory Review 

This action is a ‘‘significant regulatory 

action’’ as defined under section 3(f)(1) 

of Executive Order 12866 (58 FR 51735, 

October 4, 1993), as amended by 

Executive Order 14094 (88 FR 21879, 

April 11, 2023). Accordingly, EPA 

submitted this action to the Office of 

Management and Budget (OMB) for 

Executive Order 12866 review. 

Documentation of any changes made in 

response to the Executive Order 12866 

review is available in the docket. EPA 

prepared an analysis of the potential 

costs and benefits associated with this 

action. This analysis, entitled 

‘‘Economic Analysis for the Final TSCA 

Section 8(a)(7) Reporting and 

Recordkeeping Requirements for 

Perfluoroalkyl and Polyfluoroalkyl 

Substances’’ (Ref. 1), is also available in 

the docket and is briefly summarized in 

Unit 1.E. 

B. Paperwork Reduction Act (PRA) 

The information collection 

requirements in this rule will be 


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submitted for approval to OMB under 

the PRA, 44 U.S.C. 3501 et seq. The 

Information Collection Request (ICR) 

document that EPA prepared has been 

assigned the EPA ICR No. 2682.02 (Ref. 

28) and the OMB Control number 2070– 

0217. You can find a copy of the ICR in 

the docket for this action, and it is 

briefly summarized here. The 

information collection requirements are 

not enforceable until OMB approves 

them. 

The reporting requirements identified 

in the rule will enable EPA to meet the 

statutory obligations required by TSCA 

section 8(a)(7) and collect data related to 

the identities, manufacture, use, 

exposure, and disposal of PFAS 

manufactured in the United States since 

2011. These one-time reporting 

requirements will also help the Agency 

to collect existing information on the 

health and environmental effects of 

PFAS. EPA intends to use information 

collected under the rule to assist in 

chemical assessments under TSCA, and 

to inform any additional work necessary 

under environmental protection 

mandates beyond TSCA. Respondents 

may claim some of the information 

reported to EPA under the rule as CBI 

under TSCA section 14. TSCA section 

14(c) requires a supporting statement 

and certification for confidentiality 

claims asserted after June 22, 2016. 

Respondents/affected entities: PFAS 

manufacturers (including importers). 

See Unit I.A. 

Respondent obligation to respond: 

Mandatory. TSCA section 8(a) and 40 

CFR part 705. 

Total estimated number of 

respondents: 131,410. 

Frequency of response: One time. 

Total estimated burden: 3,878,744 

hours (per year). Burden is defined at 5 

CFR 1320.3(b). 

Total estimated cost: $281 million 

(per year) and $266.7 million (per year) 

using a 3 percent and 7 percent discount 

rate, respectively, which includes no 

annualized capital or operation and 

maintenance costs. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for the EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. When 

OMB approves this ICR, the Agency will 

announce that approval in the Federal 

Register and publish a technical 

amendment to 40 CFR part 9 to display 

the OMB control number for the 

approved information collection 

activities contained in this final rule. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to the RFA, 5 U.S.C. 601 et 

seq., EPA prepared an IRFA for the 

proposed rule and convened an SBAR 

Panel under RFA sections 603 and 

609(b) to obtain advice and 

recommendations from small entity 

representatives that potentially would 

be subject to the rule’s requirements. 

Summaries of the IRFA and Panel 

recommendations are presented in the 

proposed rule’s NODA (Ref. 1). 

As required by RFA section 604, EPA 

prepared a final regulatory flexibility 

analysis (FRFA) for this action. The 

FRFA addresses the issues raised by 

public comments on the IRFA for the 

proposed rule. The complete FRFA is 

available for review in the docket (Ref. 

29) and is summarized here. 

• Statement of need and rule 

objectives. Section 7351 of the FY2020 

NDAA amended TSCA by adding 

section 8(a)(7), which obligates EPA to 

promulgate a rule by January 1, 2023, 

that requires each person who has 

manufactured PFAS in any year since 

2011 to report and maintain records, for 

each year, information described in 

TSCA section 8(a)(2)(A)–(G). This 

includes a broad range of information, 

such as information related to chemical 

identity and structure, production, use, 

exposure, disposal, and health and 

environmental effects. In addition, EPA 

believes that the collected data may 

help provide more information about 

PFAS manufacture, and to the extent 

that new information indicates the 

presence of negative externalities or 

data gaps, inform future agency actions 

and/or legislation governing the 

manufacture, processing, use, and 

disposal of PFAS. 

EPA developed this final rule after 

considering findings from information 

provided in public comments on the 

proposed rule, findings from and 

comments on the SBAR Panel, and 

public comments on the IRFA. The final 

rule requires all manufacturers of PFAS 

in any year since 2011 to report certain 

information to EPA related to chemical 

identity, categories of use, volume 

manufactured, byproducts, 

environmental and health effects, 

worker exposure, and disposal (i.e., the 

TSCA section 8(a)(2)(A)–(G) 

requirements). This rule also requires a 

five-year retention period for all 

relevant records following the 

submission period. 

• Significant comments on the IRFA. 

In response to the IRFA and notice of 

data availability, EPA received 44 

unique comments in the docket. EPA 

has provided a comprehensive summary 

of all comments received and EPA’s 

responses in a supporting document 

that is included in the docket for this 

rulemaking (Ref. 21; see Part 2). 

• SBA Office of Advocacy comments 

and EPA response. EPA received 

comments from SBA’s Office of 

Advocacy on the proposed rule and the 

IRFA. SBA’s comments and EPA’s 

responses are in the Responses to 

Comments document for this rule (Ref. 

21) and in the FRFA (Ref. 29). SBA 

comments that led to changes to the 

proposed rule, and EPA’s responses to 

those comments, are also summarized in 

this unit. 

Comments: EPA has improperly 

certified the rule under the RFA. EPA 

should convene a Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) Panel and consider burdenreducing compliance flexibilities for 

small businesses. Additionally, EPA 

underestimated the impact of 

compliance costs associated with the 

proposed reporting requirements. 

Response: EPA initially certified the 

proposed rule under the RFA based on 

all information available to it at the time 

of proposal. However, after receiving 

additional information related to the 

scope of small entities (including article 

importers) potentially impacted by the 

proposed rule, EPA updated its 

estimated scope of the universe of small 

entities potentially affected (including 

article importers) and the small entity 

compliance costs. Thus, EPA convened 

an SBAR Panel in April 2022. The Panel 

concluded in August 2022, and EPA 

subsequently published the Panel 

Report, updated Economic Analysis, 

and IRFA for public comment in 

November 2022. Input received through 

the Panel and during the subsequent 

comment period for the IRFA were 

considered in the development of this 

final rule, including comments related 

to EPA’s small entity analysis. As a 

result of public input, EPA identified 

certain regulatory alternatives to the 

proposed rule, which EPA is 

implementing in the final rule: 

streamlined reporting forms for article 

importers and for manufacturers of low 

quantities of R&D substances; extending 

the reporting deadline; providing 

additional guidance on the TSCA 

section 8(a) reporting standard for 

article importers. These modifications to 

the proposed rule reduce compliance 

costs without a complete exemption of 

small entities. EPA has not made a 

determination that a complete 

exemption of small entities is not legally 

viable in this rulemaking. EPA believes 

such an exemption would result in 

diminished collection of reasonably 

known or ascertainable information 

about PFAS manufacturing and import 


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since 2011 and therefore is exercising its 

discretion to not implement this 

alternative. EPA estimates that each 

manufacturer would incur $2,240 in 

costs to complete the streamlined R&D 

form and $41,850 in costs to complete 

the general reporting form. Thus, 

incurring a total of $44,089 in costs per 

firm for form completion, compared to 

$52,739 without the streamlined form. 

For the streamlined form for article 

importers, EPA estimates that each 

article importer will incur an average of 

approximately 91.7 burden hours and 

$7,531 in costs per firm. Without a 

streamlined reporting form, EPA 

estimates that each article importer 

would incur an average of 

approximately 168 burden hours and 

$13,818 in costs for form completion. 

Additionally, extending the reporting 

deadline may reduce the opportunity 

costs if firms are diverting resources 

from other business activities to report 

information under the rule. This may be 

particularly true for small entities. See 

Table 24 for more information on the 

costs associated with the finalized 

option and alternatives identified in the 

IRFA (Ref. 23). 

• Estimate of the number of small 

entities to which the final rule applies. 

This final rule will impact PFAS 

manufacturers, including article 

importers, across a broad number of 

industries, including the following: 

utilities; construction; manufacturing; 

wholesale and retail trade; and some 

waste management. Entities who solely 

process, distribute, and/or use PFAS, 

and do not manufacture (including 

import) PFAS, are not covered. EPA 

estimates that approximately 97% of all 

firms potentially affected by this rule 

would meet the SBA standard of ‘‘small 

business,’’ for a total of 128,051 affected 

small entities. It is expected that all 

128,051 firms will undertake structural 

definition familiarization, some rule 

familiarization activity, and compliance 

determination, including article 

importers that do not report under this 

rule. However, EPA does not assume 

that all potentially affected firms will 

ultimately have known or reasonably 

ascertainable information to report, so 

13,021 small entities are estimated to 

report under this rule. 

• Reporting, recordkeeping, and other 

compliance requirements of the final 

rule. 

i. Compliance requirements. Pursuant 

to TSCA section 8(a)(7), EPA is 

finalizing this reporting and 

recordkeeping rule for entities who have 

manufactured a PFAS in any year since 

January 1, 2011. For each year since 

January 1, 2011, PFAS manufacturers 

(including importers) are required to 

report the following types of 

information for each PFAS to the extent 

it is known or reasonably ascertainable: 

chemical identity, production volume, 

categories of use, byproducts, worker 

exposure, disposal practices, and 

existing information concerning 

environmental or health effects. In 

instances where reporters have already 

submitted the requested information to 

EPA under certain reporting programs, 

they will not be required to re-report. 

The reporters will simply indicate they 

have already submitted such 

information to EPA. The reporting 

deadline is 18 months following the 

effective date of this rule, except for 

small manufacturers (defined at 40 CFR 

704.3) whose reporting obligations 

exclusively arise from article imports; 

the latter’s reporting deadline is 24 

months following the effective date of 

this rule. The reporting deadline is then 

followed by a five-year recordkeeping 

period. 

ii. Classes of small entities subject to 

the compliance requirements. The small 

entities that are potentially affected by 

this rule are manufacturers (including 

importers) who have manufactured 

(including imported) PFAS in any year 

since January 1, 2011. This includes 

entities who have imported articles 

containing PFAS in any year since 

January 1, 2011. 

iii. Professional skills needed to 

comply. Understanding some of the 

reporting requirements may involve 

special skills or expertise, though hiring 

or contracting such skills specifically for 

this rule are not required to comply, 

given the TSCA section 8(a) reporting 

standard of ‘‘known or reasonably 

ascertainable.’’ For example, 

understanding the rule’s structural 

definition of PFAS and other reporting 

requirements may involve special 

expertise of chemistry. EPA assumes 

that chemical manufacturing and 

importing firms and large article 

importers will have staff with the 

technical knowledge to understand a 

structural definition more easily than 

small article importers. Based on input 

from the Small Entity Representatives, 

EPA estimated the cost of small article 

importer firms contracting outside help 

to understand the chemical structural 

definition, despite it not being a 

necessary step for compliance. Small 

article importers that contract outside 

help (which is not required for this 

rule’s compliance) would incur $1,212 

in structural definition compliance 

costs, while small article importers that 

do not contract outside help would 

incur approximately $831. Additionally, 

environmental and health effects data 

may require some technical knowledge 

to report. 

• Steps taken to reduce economic 

impact to small entities. 

i. Small Business Advocacy Review 

Panel. As required by RFA section 

609(b), EPA convened an SBAR Panel to 

obtain advice and recommendations 

from small entity representatives that 

potentially would be subject to the 

rule’s requirements. A copy of the full 

SBAR Panel Report (Ref. 22) is available 

in the docket. The comments received 

on the proposed rule, the IRFA and 

EPA’s responses to those comments are 

summarized in Unit IV and in further 

detail in the Response to Comments 

document in the docket (Ref. 21). 

ii. Alternatives considered. EPA 

considered a wide variety of alternatives 

to the proposed rule. EPA considered 

the impact (both cost and in anticipated 

reporting) of providing exemptions for 

all small businesses, or a portion of 

small businesses (e.g., small article 

importers, small manufacturers using 

the TSCA section 8 definition, or 

entities below various sales thresholds). 

EPA also evaluated the impact of 

exemptions for certain substances, 

including imported articles, byproducts, 

impurities, non-isolated intermediates, 

and R&D substances. EPA also evaluated 

the impact of implementing a 

production volume-based reporting 

threshold in this rule. For each of these 

alternatives, EPA found that it would 

reduce the amount of PFAS reporting of 

reasonably known or ascertainable 

information from PFAS manufacturers 

(including importers) under TSCA 

section 8(a)(7). The amount of reporting 

that certain alternatives would reduce 

varied, ranging from exempting 

approximately 91% of all potentially 

covered firms from reporting under a 

small manufacturer exemption for any 

firm with under $12 million in sales 

(which would have resulted in a final 

rule costing small businesses 

approximately $48.8 million under a 7 

percent discount rate), to exempting 

69% of firms (all article importers) 

under an exemption for just article 

importers with sales below $2 million 

(which would have resulted in a final 

rule costing small businesses 

approximately $229.5 million under a 7 

percent discount rate). EPA also 

considered applying a production 

volume reporting threshold of both 

2,500 lbs per year and 25,000 lbs per 

year, to align with CDR reporting 

thresholds. Because the amount of 

reporting and burden under a reporting 

threshold was difficult to estimate with 

existing data, EPA conducted sensitivity 

analyses for this alternative, based on 

the estimated number of PFAS article 


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importers who would be able to 

determine whether they are below the 

reporting threshold. On the low-end 

estimate for this alternative (i.e., 5% of 

affected article importers import PFAScontaining articles above threshold), 

EPA estimates that total number of 

PFAS reports submitted would decrease 

by 49 percent, and total small business 

costs would be approximately $736.6 

million under a 7 percent discount rate. 

On the high-end (i.e., 9.5% of affected 

article importers import PFAScontaining articles above threshold), 

EPA estimates the total number of PFAS 

reports submitted to decrease by 5%, 

with total small business costs of $785.2 

million under a 7 percent discount rate. 

Given the reduced reporting expected 

under alternatives including various 

exemptions and reporting thresholds, 

EPA determined that implementing 

such alternatives contradicted EPA’s 

mandate under section 8(a)(7) to collect 

information from ‘‘each person’’ who 

had manufactured a PFAS. Further, 

while EPA recognizes there is a tradeoff 

between rule compliance costs and 

information collection, PFAS exposure 

presents significant human health and 

environmental concerns that it is critical 

for EPA to collect as much existing 

information on PFAS presence in 

commerce (including through disposal) 

as possible. 

In addition to alternatives related to 

reporting exemptions and reporting 

thresholds, EPA considered limiting the 

scope of PFAS subject to this rule to a 

finite list, rather than a structural 

definition. This alternative simplifies 

rule familiarization for affected entities 

and removes the cost and burden of 

understanding the structural definition 

of PFAS. Additionally, it reduces 

compliance determination costs for 

affected firms. However, this also 

significantly limits the number of PFAS 

subject to the rule and excludes many 

PFAS that cannot be listed due to CBI 

claims but are active in U.S. commerce. 

If EPA limited the scope to a discrete 

list of PFAS on the TSCA Inventory and 

LVEs that could be specifically named 

under the final definition, 602 PFAS 

would be subject to the rule. This 

alternative would result in an estimated 

50% decrease in reporting forms 

submitted, along with an estimated 

small business cost of approximately 

$626.4 million under a 7 percent 

discount rate. 

However, EPA also considered 

alternatives to the proposed rule that the 

Agency is finalizing to reduce burden 

on small entities. EPA considered 

providing streamlined reporting form 

options for both imported articles and 

R&D substances manufactured in low 

quantities (i.e., no more than 10 kg/ 

year). Based on EPA’s knowledge of 

manufacturers of those substances, and 

public input from commenters and 

small entity representatives, EPA 

believes such manufacturers have less 

information that is known or reasonably 

ascertainable to them. Therefore, the 

streamlined reporting form reduces the 

burden of reporting on the standard 

form while still enabling EPA to collect 

all known or reasonably ascertainable 

historical PFAS data. Additionally, EPA 

considered and is finalizing a longer 

compliance timeframe for all reporting 

entities. Providing an additional six 

months for a data collection period 

ahead of the reporting period will 

reduce the opportunity costs on affected 

firms, particularly small entities, 

without sacrificing any PFAS 

manufacturing data. In addition, EPA is 

granting small manufacturers (as 

defined at 40 CFR 704.3) who would 

report exclusively as article importers 

an additional six months to collect data. 

Therefore, those small entities would 

have 24 months from the effective date 

of this rule to submit information on 

their imported articles. EPA is finalizing 

such alternatives to meet the Agency’s 

obligations under TSCA sections 

8(a)(5)(A) through (C), as this rule is 

requesting information that is neither 

duplicative nor unnecessary and will 

not exclude manufacturers who are 

likely to have relevant information, 

while minimizing costs on small 

manufacturers to the extent feasible. 

• Small entity compliance guide. EPA 

prepared a Small Entity Compliance 

Guide to help small entities comply 

with the rule. This guide is available in 

the docket for this rulemaking and will 

be available on EPA’s website prior to 

the effective date of this final rule (Ref. 

14). 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action contains a Federal 

mandate under UMRA, 2 U.S.C. 1531– 

1538, that may result in expenditures of 

$100 million or more for State, local, 

and Tribal governments, in the 

aggregate, or for private sector in any 

one year. Accordingly, the EPA has 

prepared a written statement (Ref. 30) as 

required under UMRA section 202 that 

is include in the docket for this action 

and is briefly summarized here. 

1. Authorizing legislation. This rule is 

issued under the authority of TSCA 

section 8(a)(7) (15 U.S.C. 2607(a)(7)). 

2. Benefit-cost analysis. EPA has 

prepared an Economic Analysis (Ref. 2) 

and a Final Regulatory Flexibility 

Analysis (Ref. 29) to evaluate, among 

other things, the benefits and costs of 

this rule as well as various regulatory 

options. The rule is calculated to result 

in a total one-time cost to the private 

sector of approximately $843 million 

using a 3 percent discount rate and $800 

million using a 7 percent discount rate. 

When adjusted for inflation, the $100 

million UMRA threshold is equivalent 

to approximately $184 million. Thus, 

the cost of the rule to the private sector 

in the aggregate exceeds the inflationadjusted UMRA threshold. 

Because this is an informationcollecting rule, EPA is not able to 

quantitatively measure the associated 

benefits. However, the rule may supply 

information on PFAS to which Federal 

agencies (and the public) do not 

currently have access. By enhancing the 

data supplied to risk-screening and riskmanagement programs, EPA expects to 

more effectively and expeditiously 

evaluate and manage any potential 

unreasonable risk posed by PFAS. The 

more EPA can base its decisions on 

actual data rather than on assumptions, 

the better EPA is able to tailor its risk 

management decisions to the level of 

actual risk, whether higher or lower 

than it would be if based on 

assumptions alone. Ultimately, 

enhancing the risk evaluation process 

will have positive consequences for 

human health and the environment and 

may enable a more efficient allocation of 

EPA’s and society’s resources. 

Additionally, this rule fulfills EPA’s 

obligations under TSCA section 8(a)(7). 

3. Impacts on State, local, and Tribal 

governments. This rule does not contain 

a significant Federal intergovernmental 

mandate because it neither imposes 

enforceable duties on State, local, or 

Tribal governments nor reduces an 

authorized amount of Federal financial 

assistance provided to State, local, or 

Tribal governments. This rule contains 

no regulatory requirements that might 

significantly or uniquely affect small 

governments. The rule would require 

reporting from certain persons who 

manufactured (including imported) 

PFAS for commercial purposes, 

including in articles. Governments do 

not typically engage in these activities, 

so State, local, and Tribal government 

entities are not expected to be subject to 

the rule’s requirements. This action is 

not subject to the requirements of 

section 203 of UMRA because it 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments. The requirements of 

this action would primarily affect 

manufacturers (including importers) of 

PFAS. 


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E. Executive Order 13132: Federalism 

This action does not have federalism 

implications, as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999) because it will not have 

substantial direct effects on States, on 

the relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000) because it will not have 

substantial direct effects on Tribal 

governments, on the relationship 

between the Federal Government and 

the Indian Tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

Tribes. It does not have substantial 

direct effects on Tribal government 

because EPA does not anticipate that 

PFAS was manufactured (including 

imported) for commercial purposes by 

Tribes so this rulemaking is not 

expected to impose substantial direct 

compliance costs on Tribal 

governments. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997) as 

applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of Executive 

Order 13045. This action is not subject 

to Executive Order 13045, because it 

does not concern an environmental 

health or safety risk. Since this action 

does not concern human health, EPA’s 

Policy on Children’s Health also does 

not apply. 

Although this action does not concern 

an environmental health or safety risk, 

this one-time data collection will aid in 

collecting all existing and reasonably 

ascertainable information related to the 

manufacturing (including importing) of 

PFAS since 2011. This rule will be of 

use in identifying current data gaps 

surrounding the knowledge of 

commercially manufactured PFAS. 

Understanding the extent of existing 

data gaps related to manufactured PFAS 

will also help inform and tailor future 

EPA actions to address PFAS as needed. 

This regulatory action establishes onetime reporting requirements for PFAS 

that will result in information on the 

quantity of PFAS to which children may 

be exposed. EPA believes that the 

information obtained as a result of this 

one-time data collection could also be 

used by the public, government agencies 

and others to identify potential 

problems, set priorities, and take 

appropriate steps to reduce any 

potential human health or 

environmental risks. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution in Commerce, or Use 

This action is not a ‘‘significant 

energy action’’ as defined in Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not likely to have a 

significant adverse effect on the supply, 

distribution or use of energy. Further, 

we have concluded that this action is 

not likely to have any adverse effect on 

the supply, distribution or use of 

energy. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve 

technical standards. As such, NTTAA 

section 12(d), 15 U.S.C. 272. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

The EPA believes that it is not 

practicable to assess whether the human 

health or environmental conditions that 

exist prior to this action result in 

disproportionate and adverse effects on 

communities with environmental justice 

concerns. The purpose of this action is 

to require reporting activity. EPA was 

unable to perform an environmental 

justice analysis because it lacks data on 

every exposure source. 

However, this regulatory action makes 

changes to the reporting requirements 

for PFAS that will result in more 

information being collected and 

provided to better evaluate exposures 

and the risks posed by such exposures 

as explained in Unit II.A., certain PFAS 

exposure may be a hazard to human 

health. This action establishes one-time 

reporting requirements for companies to 

submit to EPA certain known or 

reasonably ascertainable information on 

manufactured PFAS by those entities as 

discussed in detailed in Unit III.D. The 

determination of potential risk to 

human health and/or the environment 

depends upon many factors, including 

the toxicity of the chemical, the fate of 

the chemical in the environment, and 

the amount and duration of human or 

other exposure to the chemical. This 

action does not directly address human 

health or environmental risks. However, 

the action will increase the level of 

information available to assess 

environmental protection for all affected 

populations without having any 

disproportionate and adverse human 

health or environmental effects on any 

population, including any community 

with environmental justice concerns. 

The information obtained as a result of 

this action may be used to collect all 

existing and reasonably ascertainable 

information related to PFAS-containing 

articles will be of use in identifying 

current data gaps surrounding the 

knowledge of commercially 

manufactured PFAS, and reporting of 

PFAS within imported articles will 

enable EPA to meet its obligations under 

the FY 2020 NDAA. Understanding the 

extent of existing data gaps related to 

manufactured PFAS will also help 

inform and tailor future EPA actions to 

address PFAS as needed. EPA also 

believes that the information obtained 

as a result of this action potentially 

could be used by the public (including 

communities with environmental justice 

concerns) with access to data which 

they may use to seek lower exposures 

and consequently reductions in 

chemical risks for themselves and their 

children. Technical assistance may be 

provided to communities with 

environmental justice concerns and 

efforts will be made to ensure 

meaningful access for individuals with 

limited English proficiency and 

individuals with disabilities. This 

information can also be used by 

government agencies and others to 

identify potential problems, set 

priorities, and take appropriate steps to 

reduce any potential risks to human 

health and the environment. Therefore, 

informational benefits, of the action, 

including behavioral changes such as 

consumers avoiding specific products, 

may have positive impact on the human 

health and environmental impacts on all 

communities, including communities 

with environmental justice concerns. 

K. Congressional Review Act (CRA) 

This action is subject to the CRA, 5 

U.S.C. 801 et seq., and EPA will submit 

a rule report to each House of the 

Congress and to the Comptroller General 

of the United States. This action is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 


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List of Subjects in 40 CFR Part 705 

Chemicals, Environmental protection, 

Hazardous materials, Reporting and 

recordkeeping requirements. 

Dated: September 28, 2023. 

Michal Freedhoff, 

Assistant Administrator Office of Chemical 

Safety and Pollution Prevention. 

Therefore, for the reasons set forth in 

the preamble, 40 CFR chapter I, 

subchapter R, is amended by adding 

part 705 to read as follows: 

PART 705—REPORTING AND 

RECORDKEEPING REQUIREMENTS 

FOR CERTAIN PER- AND 

POLYFLUOROALKYL SUBSTANCES 

Sec. 

705.1 Scope, compliance, and enforcement. 

705.3 Definitions. 

705.5 Substances for which reports must be 

submitted. 

705.10 Persons who must report. 

705.12 Activities for which reporting is not 

required. 

705.15 What information to report. 

705.18 Article importer and R&D substance 

reporting options. 

705.20 When to report. 

705.22 Duplicative reporting. 

705.25 Recordkeeping requirements. 

705.30 Confidentiality claims. 

705.35 Electronic reporting. 

Authority: 15 U.S.C. 2607(a)(7). 

§ 705.1 Scope, compliance, and 

enforcement. 

(a) This part specifies reporting and 

recordkeeping procedures for 

manufacturers (including importers) of 

per- and polyfluoroalkyl substances 

(hereafter referred to as PFAS) under 

section 8(a)(7) of the Toxic Substances 

Control Act (TSCA). 

(b) TSCA section 15(3) makes it 

unlawful for any person to fail or refuse 

to submit information required under 

this part. In addition, TSCA section 

15(3) makes it unlawful for any person 

to fail to keep, and permit access to, 

records required by this part. TSCA 

section 16 provides that any person who 

violates a provision of TSCA section 15 

is liable to the United States for a civil 

penalty and may be criminally 

prosecuted. Pursuant to TSCA section 

17, the Federal Government may seek 

judicial relief to compel submission of 

TSCA section 8(a) information and to 

otherwise restrain any violation of 

TSCA section 15. TSCA section 11 

allows for inspections to assure 

compliance, and the Environmental 

Protection Agency’s (EPA) 

Administrator may by subpoena require 

the attendance and testimony of 

witnesses and the production of reports, 

papers, documents, answers to 

questions, and other information that 

the Administrator deems necessary. 

(c) Each person who reports under 

this part must maintain records that 

document information reported under 

this part and, in accordance with TSCA, 

permit access to, and the copying of, 

such records by EPA officials. 

§ 705.3 Definitions. 

The definitions in this section and the 

definitions in TSCA section 3 apply to 

this part. In addition, the definitions in 

40 CFR 704.3 also apply to this part, 

except the definition for small 

quantities solely for research and 

development. 

Article means a manufactured item 

which: 

(1) Is formed to a specific shape or 

design during manufacture; 

(2) Has end use function(s) depending 

in whole or in part upon its shape or 

design during end use; and 

(3) Has either no change of chemical 

composition during its end use or only 

those changes of composition which 

have no commercial purpose separate 

from that of the article, and that result 

from a chemical reaction that occurs 

upon end use of other chemical 

substances, mixtures, or articles; except 

that fluids and particles are not 

considered articles regardless of shape 

or design. 

Central Data Exchange or CDX means 

EPA’s centralized electronic submission 

receiving system. 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based reporting tool for the 

completion and submission of data, 

reports, and other information, or its 

successors. 

Commercial use means the use of a 

chemical substance or a mixture 

containing a chemical substance 

(including as part of an article) in a 

commercial enterprise providing 

saleable goods or services. 

Consumer use means the use of a 

chemical substance or a mixture 

containing a chemical substance 

(including as part of an article) when 

sold to or made available to consumers 

for their use. 

Environmental or health effects 

information means any information of 

any effect of a chemical substance or 

mixture containing a chemical 

substance on health or the environment 

or on both. This includes all health and 

safety studies. 

(1) Not only is information that arises 

as a result of a formal, disciplined study 

included, but other information relating 

to the effects of a chemical substance or 

mixture containing a chemical 

substance on health or the environment 

is also included. Any information that 

bears on the effects of a chemical 

substance on health or the environment 

would be included. 

(2) Examples are: 

(i) Long- and short-term tests of 

mutagenicity, carcinogenicity, or 

teratogenicity; data on behavioral 

disorders; dermatoxicity; 

pharmacological effects; mammalian 

absorption, distribution, metabolism, 

and excretion; cumulative, additive, and 

synergistic effects; and acute, 

subchronic, and chronic effects. 

(ii) Tests for ecological or other 

environmental effects on invertebrates, 

fish, or other animals, and plants, 

including acute toxicity tests, chronic 

toxicity tests, critical life-stage tests, 

behavioral tests, algal growth tests, seed 

germination tests, plant growth or 

damage tests, microbial function tests, 

bioconcentration or bioaccumulation 

tests, and model ecosystem (microcosm) 

studies. 

(iii) Assessments of human and 

environmental exposure, including 

workplace exposure, and impacts of a 

particular chemical substance or 

mixture containing a chemical 

substance on the environment, 

including surveys, tests, and studies of: 

Biological, photochemical, and 

chemical degradation; structure/activity 

relationships; air, water, and soil 

transport; biomagnification and 

bioconcentration; and chemical and 

physical properties, e.g., boiling point, 

vapor pressure, evaporation rates from 

soil and water, octanol/water partition 

coefficient, and water solubility. 

(iv) Monitoring data, including but 

not limited to when they have been 

aggregated and analyzed to measure the 

exposure of humans or the environment 

to a chemical substance or mixture 

containing a chemical substance. 

Health and safety studies means any 

study of any effect of a chemical 

substance or mixture on health or the 

environment or on both, including 

underlying information and 

epidemiological studies, studies of 

occupational exposure to a chemical 

substance or mixture, toxicological, 

clinical, and ecological studies of a 

chemicals substance or mixture 

containing a chemical substance, and 

any test performed under TSCA. The 

following information is not part of a 

health and safety study: 

(1) The name, address, or other 

identifying information for the 

submitting company, including 

identification of the laboratory that 

conducted the study in cases where the 

laboratory is part of or closely affiliated 

with the submitting company; 


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(2) Internal product codes (i.e., code 

names for the test substance used 

internally by the submitting company or 

to identify the test substance to the test 

laboratory); 

(3) Names and contact details for 

testing laboratory personnel and names 

and other private information for health 

and safety study participants or persons 

involved in chemical incidents such as 

would typically be withheld under 5 

U.S.C. 552(b)(6) or under other privacy 

laws; and 

(4) Information pertaining to test 

substance product development, 

advertising, or marketing plans, or to 

cost and other financial data. 

Highest-level U.S. parent company 

means the highest-level company of the 

site’s ownership hierarchy as of the start 

of the submission period during which 

data are being reported according to the 

following instructions. The highest-level 

U.S. parent company is located within 

the United States. The following rules 

govern how to identify the highest-level 

U.S. parent company: 

(1) If the site is entirely owned by a 

single U.S. company that is not owned 

by another company, that single 

company is the U.S. parent company. 

(2) If the site is entirely owned by a 

single U.S. company that is, itself, 

owned by another U.S.-based company 

(e.g., it is a division or subsidiary of a 

higher-level company), the highest-level 

domestic company in the ownership 

hierarchy is the U.S. parent company. 

(3) If the site is owned by more than 

one company (e.g., company A owns 40 

percent, company B owns 35 percent, 

and company C owns 25 percent), the 

company with the largest ownership 

interest in the site is the U.S. parent 

company. If a higher-level company in 

the ownership hierarchy owns more 

than one ownership company, then 

determine the entity with the largest 

ownership by considering the lowerlevel ownerships in combination (e.g., 

corporation X owns companies B and C, 

for a total ownership of 60 percent for 

the site). 

(4) If the site is owned by a 50:50 joint 

venture or a cooperative, the joint 

venture or cooperative is its own parent 

company. If the site is owned by a U.S. 

joint venture or cooperative, the highest 

level of the joint venture or cooperative 

is the U.S. parent company. 

(5) If the site is federally owned, the 

highest-level Federal agency or 

department is the U.S. parent company. 

(6) If the site is owned by a nonFederal public entity, that entity (such 

as a municipality, State, or tribe) is the 

U.S. parent company. 

Industrial function means the 

intended physical or chemical 

characteristic for which a chemical 

substance or mixture is consumed as a 

reactant; incorporated into a 

formulation, mixture, reaction product 

or article; repackaged; or used. 

Industrial use means use at a site at 

which one or more chemical substances 

or mixtures are manufactured (including 

imported) or processed. 

Intended for use by children means 

the chemical substance or mixture is 

used in or on a product that is 

specifically intended for use by children 

aged 14 or younger. A chemical 

substance or mixture containing a 

chemical substance is intended for use 

by children when the submitter answers 

‘‘yes’’ to at least one of the following 

questions for the product into which the 

submitter’s chemical substance or 

mixture containing a chemical 

substance is incorporated: 

(1) Is the product commonly 

recognized (i.e., by a reasonable person) 

as being intended for children aged 14 

or younger? 

(2) Does the manufacturer of the 

product state through product labeling 

or other written materials that the 

product is intended for or will be used 

by children aged 14 or younger? 

(3) Is the advertising, promotion, or 

marketing of the product aimed at 

children aged 14 or younger? 

Known to or reasonably ascertainable 

by means all information in a person’s 

possession or control, plus all 

information that a reasonable person 

similarly situated might be expected to 

possess, control, or know. 

Manufacture means to import into the 

customs territory of the United States 

(as defined in general note 2 of the 

Harmonized Tariff Schedule of the 

United States (19 U.S.C. 1202)), 

produce, or manufacture for commercial 

purposes. 

Manufacture for commercial purposes 

means: 

(1) To import, produce, or 

manufacture with the purpose of 

obtaining an immediate or eventual 

commercial advantage for the 

manufacturer, and includes among other 

things, such ‘‘manufacture’’ of any 

amount of a chemical substance or 

mixture containing a chemical 

substance: 

(i) For commercial distribution, 

including for test marketing; and/or 

(ii) For use by the manufacturer, 

including use for product research and 

development, or as an intermediate. 

(2) Manufacture for commercial 

purposes also applies to substances that 

are produced coincidentally during the 

manufacture, processing, use, or 

disposal of another substance or mixture 

containing a chemical substance, 

including both byproducts that are 

separated from that other substance or 

mixture containing a chemical 

substance and impurities that remain in 

that substance or mixture containing a 

chemical substance. Such byproducts 

and impurities may, or may not, in 

themselves have commercial value. 

They are nonetheless produced for the 

purpose of obtaining a commercial 

advantage since they are part of the 

manufacture of a chemical product for 

a commercial purpose. 

Per- and polyfluoroalkyl substances or 

PFAS means, for the purpose of this 

part, any chemical substance or mixture 

containing a chemical substance that 

structurally contains at least one of the 

following three sub-structures: 

(1) R-(CF2)-CF(R′)R′′, where both the 

CF2 and CF moieties are saturated 

carbons. 

(2) R-CF2OCF2-R′, where R and R′ can 

either be F, O, or saturated carbons. 

(3) CF3C(CF3)R′R′′, where R′ and R′′ 

can either be F or saturated carbons. 

Possession or control means in 

possession or control of the submitter, 

or of any subsidiary, partnership in 

which the submitter is a general partner, 

parent company, or any company or 

partnership which the parent company 

owns or controls, if the subsidiary, 

parent company, or other company or 

partnership is associated with the 

submitter in the research, development, 

test marketing, or commercial marketing 

of the chemical substance in question. 

(A parent company owns or controls 

another company if the parent owns or 

controls 50 percent or more of the other 

company’s voting stock. A parent 

company owns or controls any 

partnership in which it is a general 

partner.) Information is included within 

this definition if it is: 

(1) In files maintained by submitter’s 

employees who are: 

(i) Associated with research, 

development, test marketing, or 

commercial marketing of the chemical 

substance in question; and/or 

(ii) Reasonably likely to have such 

data. 

(2) Maintained in the files of other 

agents of the submitter who are 

associated with research, development, 

test marketing, or commercial marketing 

of the chemical substance in question in 

the course of their employment as such 

agents. 

Research and development (R&D) 

means activities intended solely as 

scientific experimentation, research, or 

analysis. R&D focuses on the analysis of 

the chemical or physical characteristics, 

the performance, or the production 

characteristics of a chemical substance, 

a mixture containing the substance, or 


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an article. R&D encompasses a wide 

range of activities which may occur in 

a laboratory, pilot plant, commercial 

plant outside the research facility, or at 

other sites appropriate for R&D. General 

distribution of chemical substances to 

consumers does not constitute R&D. 

Site-limited means a chemical 

substance is manufactured and 

processed only within a site and is not 

distributed as a chemical substance or 

as part of a mixture or article containing 

a chemical substance outside the site. 

Imported chemical substances are never 

site-limited. 

Worker means someone at a site of 

manufacture, import, or processing who 

performs work activities near sources of 

a chemical substance or mixture or 

directly handles the chemical substance 

or mixture during the performance of 

work activities. 

§ 705.5 Substances for which reports must 

be submitted. 

The requirements of this part apply to 

all chemical substances and mixtures 

containing a chemical substance 

(including articles) that are a PFAS, 

consistent with the definition of PFAS 

at § 705.3. 

§ 705.10 Persons who must report. 

Persons who have manufactured for 

commercial purposes a chemical 

substance identified in § 705.5 at any 

period from January 1, 2011, through 

the end of the last calendar year prior 

to November 13, 2023, except as 

described in § 705.12, is subject to the 

requirements of this part. 

§ 705.12 Activities for which reporting is 

not required. 

Reporting under this part is not 

required for the import of municipal 

solid waste streams for the purpose of 

disposal or destruction of the waste. 

Additionally, reporting is not required 

for a Federal agency which imports 

PFAS when it is not for any immediate 

or eventual commercial advantage. 

§ 705.15 What information to report. 

For the one-time submission, persons 

identified in § 705.10 must report to 

EPA, for each site of each of the 

chemical substances identified in 

§ 705.5, the following information to the 

extent known to or reasonably 

ascertainable by them, except as 

allowed under § 705.18. In the event 

that actual data is not known to or 

reasonably ascertainable by the 

submitter, then reasonable estimates 

may be submitted: 

(a) Company and plant site 

information. The following currently 

correct company and plant site 

information must be reported for each 

site at which a reportable chemical 

substance is manufactured (see 40 CFR 

711.3 for the ‘‘site’’ for importers): 

(1) The highest-level U.S. parent 

company name, address, and Dun and 

Bradstreet D–U–N–S® (D&B) number, if 

one exists. 

(2) The name of a person who will 

serve as Authorized Official for the 

submitter company, and who will be 

able to sign the certification statement 

as described in § 705.30(d), the 

Authorized Official’s full mailing 

address, telephone number, and email 

address. 

(3) The name of a person who will 

serve as technical contact for the 

submitter company, and who will be 

able to answer questions about the 

information submitted by the company 

to EPA, the contact person’s full mailing 

address, telephone number, and email 

address. 

(4) The name, full street address, and 

six-digit North American Industry 

Classification System (NAICS) code(s) of 

the site. A submitter under this part 

must include the appropriate D&B 

number for each plant site reported, and 

the county or parish (or other 

jurisdictional indicator) in which the 

plant site is located. A submitter under 

this part must obtain a D&B number for 

the site reported if none exists. A 

submitter under this part must also 

provide other site identification 

numbers, including the Facility Registry 

Service (FRS) identification number, if 

they exist. 

(b) Chemical-specific information. 

The following chemical-specific 

information must be reported for each 

chemical substance that is a PFAS 

manufactured for each year since 

January 1, 2011, except as allowed 

under § 705.18. This includes each 

chemical substance that is a PFAS and 

incorporated into mixtures: 

(1) The common or trade name, the 

chemical identity, and, except for 

chemical substances that are Class 1 

substances on the TSCA Inventory, the 

representative molecular structure of 

each PFAS for which such a report is 

required. 

(i) The specific, currently correct 

Chemical Abstracts (CA) Index name as 

used to list the chemical substance on 

the TSCA Inventory and the correct 

corresponding Chemical Abstracts 

Service Registry Number (CASRN) for 

each reportable PFAS at each site. 

Submitters who wish to report chemical 

substances listed on the confidential 

portion of the TSCA Inventory will need 

to report the chemical substance using 

a TSCA Accession Number. If a 

submitter has a low-volume exemption 

(LVE) case number for the chemical 

substance, that number may also be 

used if a CASRN is not known to or 

reasonably ascertainable by the 

submitter. 

(ii) In addition to reporting the 

number itself, submitters must specify 

the type of number they are reporting by 

selecting from among the codes in table 

1 to this paragraph (b)(1)(ii). 

TABLE 1 TO PARAGRAPH (b)(1)(ii)— 

CODES TO SPECIFY TYPE OF CHEMICAL IDENTIFYING NUMBER

Code Number type 

A ........ TSCA Accession Number. 

C ....... Chemical Abstracts Service Registry 

Number (CASRN). 

L ........ Low-volume exemption (LVE) case 

number. 

(iii) If the CASRN or specific 

identifier (i.e., Accession Number or 

LVE number) of the PFAS is not known 

to or reasonably ascertainable (NKRA) to 

the submitter (e.g., if the chemical 

identity is claimed as confidential 

business information by the submitter’s 

supplier, or if the submitter knows they 

have a PFAS but are unable to ascertain 

its specific identifier and/or specific 

chemical identity), the submitter may 

provide a generic name or description of 

the PFAS and also initiate a joint 

submission if the secondary submitter is 

known. The submitter may only initiate 

a joint submission if the CASRN or the 

specific identifier (i.e., Accession 

Number or LVE number) is not known 

or reasonably ascertainable, and a 

secondary submitter (who would 

provide such information) is known. 

The manufacturer (including importer) 

must use the reporting tool described 

under § 705.35 to ask the supplier or 

other entity to provide the chemical 

identity directly to EPA in a joint 

submission. Such request must include 

instructions for submitting chemical 

identity information electronically, 

using e-CDRweb and CDX (see 40 CFR 

711.35), and for clearly referencing the 

manufacturer’s (including importer) 

submission. Contact information for the 

supplier or other entity, a trade name or 

other designation for the chemical 

substance, and a copy of the request to 

the supplier or other entity must be 

included with the manufacturer’s 

(including importer) submission. If, 

after conducting due diligence and 

reviewing known or reasonably 

ascertainable information, a secondary 

submitter to complete the joint 

submission is not known, the reporter 

may indicate that the secondary 

submitter is NKRA. However, the PFAS 

manufacturer would be required to 


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provide as much identifying detail as 

they have regarding the PFAS identity, 

and would be able to report to EPA 

without initiating a joint submission 

even if they do not know the underlying 

identity of the chemical substance. 

(2) The physical form(s) of the PFAS 

as it is sent off-site from each site. If the 

PFAS is site-limited, you must report 

the physical form(s) of the PFAS at the 

time it is reacted on-site to produce a 

different chemical substance. For each 

PFAS at each site, the submitter must 

report as many physical forms as 

applicable from among the physical 

forms listed in this unit: 

(i) Dry powder. 

(ii) Pellets or large crystals. 

(iii) Water- or solvent-wet solid. 

(iv) Other solid. 

(v) Gas or vapor. 

(vi) Liquid. 

(c) Categories of use. For each year 

since January 1, 2011, report the 

following information on categories of 

use of each chemical substance that is 

a PFAS manufactured for commercial 

purposes. 

(1) Industrial processing and use 

information. A designation indicating 

the type of industrial processing or use 

operation(s) at each site that receives a 

PFAS from the submitter site directly or 

indirectly (whether the recipient site(s) 

are controlled by the submitter site or 

not). For each PFAS, report the letters 

which correspond to the appropriate 

processing or use operation(s) listed in 

table 2 to this paragraph (c)(1). A 

particular designation may need to be 

reported more than once, to the extent 

that a submitter reports more than one 

sector that applies to a given 

designation under this paragraph (c)(1). 

TABLE 2 TO PARAGRAPH (c)(1)— 

CODES FOR REPORTING TYPE OF INDUSTRIAL PROCESSING OR USE OPERATION

Designation Operation 

PC ................ Processing as a reactant. 

PF ................. Processing—incorporation 

into formulation, mixture, or 

reaction product. 

PA ................ Processing—incorporation 

into article. 

PK ................ Processing—repackaging. 

U ................... Use—non-incorporative activities. 

(2) Corresponding sector code. A code 

indicating the sector(s) that best 

describes the industrial activities 

associated with each industrial 

processing or use operation reported 

under this section. For each chemical 

substance, report the code that 

corresponds to the appropriate sector(s) 

listed in table 3 to this paragraph (c)(2). 

A particular sector code may need to be 

reported more than once, to the extent 

that a submitter reports more than one 

function code that applies to a given 

sector code under this paragraph (c)(2). 

TABLE 3 TO PARAGRAPH (c)(2)— 

CODES FOR REPORTING INDUSTRIAL

SECTORS

Code Sector description 

IS1 ..... Agriculture, forestry, fishing, and 

hunting. 

IS2 ..... Oil and gas drilling, extraction, and 

support activities. 

IS3 ..... Mining (except oil and gas) and support activities. 

IS4 ..... Utilities. 

IS5 ..... Construction. 

IS6 ..... Food, beverage, and tobacco product manufacturing. 

IS7 ..... Textiles, apparel, and leather manufacturing. 

IS8 ..... Wood product manufacturing. 

IS9 ..... Paper manufacturing. 

IS10 ... Printing and related support activities. 

IS11 ... Petroleum refineries. 

IS12 ... Asphalt paving, roofing, and coating 

materials manufacturing. 

IS13 ... Petroleum lubricating oil and grease 

manufacturing. 

IS14 ... All other petroleum and coal products manufacturing. 

IS15 ... Petrochemical manufacturing. 

IS16 ... Industrial gas manufacturing. 

IS17 ... Synthetic dye and pigment manufacturing. 

IS18 ... Carbon black manufacturing. 

IS19 ... All other basic inorganic chemical 

manufacturing. 

IS20 ... Cyclic crude and intermediate manufacturing. 

IS21 ... All other basic organic chemical 

manufacturing. 

IS22 ... Plastics material and resin manufacturing. 

IS23 ... Synthetic rubber manufacturing. 

IS24 ... Organic fiber manufacturing. 

IS25 ... Pesticide, fertilizer, and other agricultural chemical manufacturing. 

IS26 ... Pharmaceutical and medicine manufacturing. 

IS27 ... Paint and coating manufacturing. 

IS28 ... Adhesive manufacturing. 

IS29 ... Soap, cleaning compound, and toilet 

preparation manufacturing. 

IS30 ... Printing ink manufacturing. 

IS31 ... Explosives manufacturing. 

IS32 ... Custom compounding of purchased 

resins. 

IS33 ... Photographic film, paper, plate, and 

chemical manufacturing. 

IS34 ... All other chemical product and preparation manufacturing. 

IS35 ... Plastics product manufacturing. 

IS36 ... Rubber product manufacturing. 

IS37 ... Non-metallic mineral product manufacturing (includes cement, clay, 

concrete, glass, gypsum, lime, and 

other non-metallic mineral product 

manufacturing). 

IS38 ... Primary metal manufacturing. 

TABLE 3 TO PARAGRAPH (c)(2)— 

CODES FOR REPORTING INDUSTRIAL

SECTORS—Continued 

Code Sector description 

IS39 ... Fabricated metal product manufacturing. 

IS40 ... Machinery manufacturing. 

IS41 ... Computer and electronic product 

manufacturing. 

IS42 ... Electrical equipment, appliance, and 

component manufacturing. 

IS43 ... Transportation equipment manufacturing. 

IS44 ... Furniture and related product manufacturing. 

IS45 ... Miscellaneous manufacturing. 

IS46 ... Wholesale and retail trade. 

IS47 ... Services. 

IS48 ... Other (requires additional information). 

(3) Corresponding function category. 

For each sector reported under 

paragraph (c)(2) of this section, the 

applicable code(s) from table 4 to this 

paragraph (c)(3) must be selected to 

designate the function category(ies) that 

best represents the specific manner in 

which the PFAS is used. 

TABLE 4 TO PARAGRAPH (c)(3)— 

CODES FOR REPORTING FUNCTION

CATEGORIES

Code Category 

F001 .. Abrasives. 

F002 .. Etching agent. 

F003 .. Adhesion/cohesion promoter. 

F004 .. Binder. 

F005 .. Flux agent. 

F006 .. Sealant (barrier). 

F007 .. Absorbent. 

F008 .. Adsorbent. 

F009 .. Dehydrating agent (desiccant). 

F010 .. Drier. 

F011 .. Humectant. 

F012 .. Soil amendments (fertilizers). 

F013 .. Anti-adhesive/cohesive. 

F014 .. Dusting agent. 

F015 .. Bleaching agent. 

F016 .. Brightener. 

F017 .. Anti-scaling agent. 

F018 .. Corrosion inhibitor. 

F019 .. Dye. 

F020 .. Fixing agent (mordant). 

F021 .. Hardener. 

F022 .. Filler. 

F023 .. Anti-static agent. 

F024 .. Softener and conditioner. 

F025 .. Swelling agent. 

F026 .. Tanning agents not otherwise specified. 

F027 .. Waterproofing agent. 

F028 .. Wrinkle resisting agent. 

F029 .. Flame retardant. 

F030 .. Fuel agents. 

F031 .. Fuel. 

F032 .. Heat transferring agent. 

F033 .. Hydraulic fluids. 

F034 .. Insulators. 

F035 .. Refrigerants. 


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TABLE 4 TO PARAGRAPH (c)(3)— 

CODES FOR REPORTING FUNCTION

CATEGORIES—Continued 

Code Category 

F036 .. Anti-freeze agent. 

F037 .. Intermediate. 

F038 .. Monomers. 

F039 .. Ion exchange agent. 

F040 .. Anti-slip agent. 

F041 .. Lubricating agent. 

F042 .. Deodorizer. 

F043 .. Fragrance. 

F044 .. Oxidizing agent. 

F045 .. Reducing agent. 

F046 .. Photosensitive agent. 

F047 .. Photosensitizers. 

F048 .. Semiconductor and photovoltaic 

agent. 

F049 .. UV stabilizer. 

F050 .. Opacifer. 

F051 .. Pigment. 

F052 .. Plasticizer. 

F053 .. Plating agent. 

F054 .. Catalyst. 

F055 .. Chain transfer agent. 

F056 .. Chemical reaction regulator. 

F057 .. Crystal growth modifiers (nucleating 

agents). 

F058 .. Polymerization promoter. 

F059 .. Terminator/Blocker. 

F060 .. Processing aids, specific to petroleum production. 

F061 .. Antioxidant. 

F062 .. Chelating agent. 

F063 .. Defoamer. 

F064 .. pH regulating agent. 

F065 .. Processing aids not otherwise specified. 

F066 .. Energy Releasers (explosives, motive propellant). 

F067 .. Foamant. 

F068 .. Propellants, non-motive (blowing 

agents). 

F069 .. Cloud-point depressant. 

F070 .. Flocculating agent. 

F071 .. Flotation agent. 

F072 .. Solids separation (precipitating) 

agent, not otherwise specified. 

F073 .. Cleaning agent. 

F074 .. Diluent. 

F075 .. Solvent. 

F076 .. Surfactant (surface active agent). 

F077 .. Emulsifier. 

F078 .. Thickening agent. 

F079 .. Viscosity modifiers. 

F080 .. Laboratory chemicals. 

F081 .. Dispersing agent. 

F082 .. Freeze-thaw additive. 

F083 .. Surface modifier. 

F084 .. Wetting agent (non-aqueous). 

F085 .. Aerating and deaerating agents. 

F086 .. Explosion inhibitor. 

F087 .. Fire extinguishing agent. 

F088 .. Flavoring and nutrient. 

F089 .. Anti-redeposition agent. 

F090 .. Anti-stain agent. 

F091 .. Anti-streaking agent. 

F092 .. Conductive agent. 

F093 .. Incandescent agent. 

F094 .. Magnetic element. 

F095 .. Anti-condensation agent. 

F096 .. Coalescing agent. 

F097 .. Film former. 

F098 .. Demulsifier. 

TABLE 4 TO PARAGRAPH (c)(3)— 

CODES FOR REPORTING FUNCTION

CATEGORIES—Continued 

Code Category 

F099 .. Stabilizing agent. 

F100 .. Alloys. 

F101 .. Density modifier. 

F102 .. Elasticizer. 

F103 .. Flow promoter. 

F104 .. Sizing agent. 

F105 .. Solubility enhancer. 

F106 .. Vapor pressure modifiers. 

F107 .. Embalming agent. 

F108 .. Heat stabilizer. 

F109 .. Preservative. 

F110 .. Anti-caking agent. 

F111 .. Deflocculant. 

F112 .. Dust suppressant. 

F113 .. Impregnation agent. 

F114 .. Leaching agent. 

F115 .. Tracer. 

F116 .. X-ray absorber. 

F999 .. Other. 

(4) Consumer and commercial use 

information. Using the applicable codes 

listed in table 5 to this paragraph (c)(4), 

submitters must designate the consumer 

and commercial product category(ies) 

that best describe the consumer and 

commercial products in which each 

PFAS is used (whether the recipient 

site(s) are controlled by the submitter 

site or not). If more than 10 codes apply 

to a PFAS, submitters need only report 

the 10 codes for PFAS that cumulatively 

represent the largest percentage of the 

submitter’s production volume for that 

chemical, measured by weight. If none 

of the listed consumer and commercial 

product categories accurately describes 

the consumer and commercial products 

in which each PFAS is used, the 

category ‘‘Other’’ may be used, and must 

include a description of the use. 

TABLE 5 TO PARAGRAPH (c)(4)— 

CODES FOR REPORTING CONSUMER

AND COMMERCIAL PRODUCT CATEGORIES

Code Category 

Chemical Substances in Furnishing, 

Cleaning, Treatment Care Products 

CC101 Construction and building materials 

covering large surface areas including stone, plaster, cement, 

glass and ceramic articles; fabrics, 

textiles, and apparel. 

CC102 Furniture & furnishings including 

plastic articles (soft); leather articles. 

CC103 Furniture & furnishings including 

stone, plaster, cement, glass and 

ceramic articles; metal articles; or 

rubber articles. 

CC104 Leather conditioner. 

TABLE 5 TO PARAGRAPH (c)(4)— 

CODES FOR REPORTING CONSUMER

AND COMMERCIAL PRODUCT CATEGORIES—Continued 

Code Category 

CC105 Leather tanning, dye, finishing, impregnation and care products. 

CC106 Textile (fabric) dyes. 

CC107 Textile finishing and impregnating/ 

surface treatment products. 

CC108 All-purpose foam spray cleaner. 

CC109 All-purpose liquid cleaner/polish. 

CC110 All-purpose liquid spray cleaner. 

CC111 All-purpose waxes and polishes. 

CC112 Appliance cleaners. 

CC113 Drain and toilet cleaners (liquid). 

CC114 Powder cleaners (floors). 

CC115 Powder cleaners (porcelain). 

CC116 Dishwashing detergent (liquid/gel). 

CC117 Dishwashing detergent (unit dose/ 

granule). 

CC118 Dishwashing detergent liquid (handwash). 

CC119 Dry cleaning and associated products. 

CC120 Fabric enhancers. 

CC121 Laundry detergent (unit-dose/granule). 

CC122 Laundry detergent (liquid). 

CC123 Stain removers. 

CC124 Ion exchangers. 

CC125 Liquid water treatment products. 

CC126 Solid/Powder water treatment products. 

CC127 Liquid body soap. 

CC128 Liquid hand soap. 

CC129 Solid bar soap. 

CC130 Air fresheners for motor vehicles. 

CC131 Continuous action air fresheners. 

CC132 Instant action air fresheners. 

CC133 Anti-static spray. 

CC134 Apparel finishing, and impregnating/ 

surface treatment products. 

CC135 Insect repellent treatment. 

CC136 Pre-market waxes, stains, and 

polishes applied to footwear. 

CC137 Post-market waxes, and polishes applied to footwear (shoe polish). 

CC138 Waterproofing and water-resistant 

sprays. 

Chemical Substances in Construction, 

Paint, Electrical, and Metal Products 

CC201 Fillers and putties. 

CC202 Hot-melt adhesives. 

CC203 One-component caulks. 

CC204 Solder. 

CC205 Single-component glues and adhesives. 

CC206 Two-component caulks. 

CC207 Two-component glues and adhesives. 

CC208 Adhesive/Caulk removers. 

CC209 Aerosol spray paints. 

CC210 Lacquers, stains, varnishes and floor 

finishes. 

CC211 Paint strippers/removers. 

CC212 Powder coatings. 

CC213 Radiation curable coatings. 

CC214 Solvent-based paint. 

CC215 Thinners. 

CC216 Water-based paint. 


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TABLE 5 TO PARAGRAPH (c)(4)— 

CODES FOR REPORTING CONSUMER

AND COMMERCIAL PRODUCT CATEGORIES—Continued 

Code Category 

CC217 Construction and building materials 

covering large surface areas, including wood articles. 

CC218 Construction and building materials 

covering large surface areas, including paper articles; metal articles; stone, plaster, cement, glass 

and ceramic articles. 

CC219 Machinery, mechanical appliances, 

electrical/electronic articles. 

CC220 Other machinery, mechanical appliances, electronic/electronic articles. 

CC221 Construction and building materials 

covering large surface areas, including metal articles. 

CC222 Electrical batteries and accumulators. 

Chemical Substances in Packaging, Paper, 

Plastic, Toys, Hobby Products 

CC990 Non-TSCA use. 

CC301 Packaging (excluding food packaging), including paper articles. 

CC302 Other articles with routine direct contact during normal use, including 

paper articles. 

CC303 Packaging (excluding food packaging), including rubber articles; 

plastic articles (hard); plastic articles (soft). 

CC304 Other articles with routine direct contact during normal use including 

rubber articles; plastic articles 

(hard). 

CC305 Toys intended for children’s use (and 

child dedicated articles), including 

fabrics, textiles, and apparel; or 

plastic articles (hard). 

CC306 Adhesives applied at elevated temperatures. 

CC307 Cement/concrete. 

CC308 Crafting glue. 

CC309 Crafting paint (applied to body). 

CC310 Crafting paint (applied to craft). 

CC311 Fixatives and finishing spray coatings. 

CC312 Modelling clay. 

CC313 Correction fluid/tape. 

CC314 Inks in writing equipment (liquid). 

CC315 Inks used for stamps. 

CC316 Toner/Printer cartridge. 

CC317 Liquid photographic processing solutions. 

Chemical Substances in Automotive, Fuel, 

Agriculture, Outdoor Use Products 

CC401 Exterior car washes and soaps. 

CC402 Exterior car waxes, polishes, and 

coatings. 

CC403 Interior car care. 

CC404 Touch up auto paint. 

CC405 Degreasers. 

CC406 Liquid lubricants and greases. 

CC407 Paste lubricants and greases. 

CC408 Spray lubricants and greases. 

TABLE 5 TO PARAGRAPH (c)(4)— 

CODES FOR REPORTING CONSUMER

AND COMMERCIAL PRODUCT CATEGORIES—Continued 

Code Category 

CC409 Anti-freeze liquids. 

CC410 De-icing liquids. 

CC411 De-icing solids. 

CC412 Lock de-icers/releasers. 

CC413 Cooking and heating fuels. 

CC414 Fuel additives. 

CC415 Vehicular or appliance fuels. 

CC416 Explosive materials. 

CC417 Agricultural non-pesticidal products. 

CC418 Lawn and garden care products. 

Chemical Substances in Products Not 

Described by Other Codes 

CC980 Other (specify). 

CC990 Non-TSCA use. 

(5) Applicable codes for each 

commercial and consumer products. For 

each consumer and commercial product 

category reported under paragraph (c)(4) 

of this section, the applicable code(s) 

described in table 4 to paragraph (c)(3) 

of this section must be selected to 

designate the function category(ies) that 

best represents the specific manner in 

which the PFAS is used. 

(6) Commercial and consumer 

products. Submitters must indicate, for 

each consumer and commercial product 

category reported under paragraph (c)(4) 

of this section, whether the use is a 

consumer or a commercial use, or both. 

(7) Consumer product category. 

Submitters must determine, within each 

consumer and commercial product 

category reported under paragraph (c)(4) 

of this section, whether any amount of 

each reportable chemical substance 

manufactured (including imported) by 

the submitter is present in (for example, 

a plasticizer chemical substance used to 

make pacifiers) or on (for example, as a 

component in the paint on a toy) any 

consumer products intended for use by 

children age 14 or younger, regardless of 

the concentration of the chemical 

substance remaining in or on the 

product. Submitters must select from 

the following options: The chemical 

substance is used in or on any consumer 

products intended for use by children; 

the chemical substance is not used in or 

on any consumer products intended for 

use by children; or information as to 

whether the chemical substance is used 

in or on any consumer products 

intended for use by children is not 

known to or reasonably ascertainable by 

the submitter. 

(8) Concentrations of PFAS. For each 

year where the PFAS is used in 

consumer or commercial products, the 

estimated typical maximum 

concentration, measured by weight, of 

the chemical substance in each 

consumer and commercial product 

category reported under paragraph (c)(4) 

of this section. For each PFAS in each 

commercial and consumer product 

category reported under paragraph (c)(4) 

of this section, submitters must select 

from among the ranges of concentrations 

listed in table 6 to this paragraph (c)(8) 

and report the corresponding code (i.e., 

M1 through M5): 

TABLE 6 TO PARAGRAPH (c)(8)— 

CODES FOR REPORTING MAXIMUM

CONCENTRATION OF CHEMICAL SUBSTANCE

Code Concentration range 

(% weight) 

M1 ..... Less than 1% by weight. 

M2 ..... At least 1 but less than 30% by 

weight. 

M3 ..... At least 30 but less than 60% by 

weight. 

M4 ..... At least 60 but less than 90% by 

weight. 

M5 ..... At least 90% by weight. 

(d) Manufactured amounts. For each 

year since January 1, 2011, the total 

amounts manufactured of each PFAS, 

including the amounts manufactured in 

each calendar year for each category of 

use as described in paragraph (c) of this 

section. 

(1) Total volume. For each year the 

PFAS was manufactured, the total 

annual volume (in pounds) of each 

PFAS domestically manufactured or 

imported at each site. The total annual 

domestically manufactured volume (not 

including imported volume) and the 

total annual imported volume must be 

separately reported. These amounts 

must be reported to two significant 

figures of accuracy. 

(2) Site designation. A designation 

indicating, for each PFAS at each site, 

whether the imported PFAS is 

physically present at the reporting site. 

(3) Volume imported. The volume 

directly exported of each PFAS 

domestically manufactured or imported 

at each site. These amounts must be 

reported to two significant figures of 

accuracy. 

(4) Production volume. The estimated 

percentage, rounded off to the closest 10 

percent, of total production volume of 

the reportable chemical substance 

associated with each combination of 

industrial processing or use operation, 

sector, and function category as reported 

in paragraph (c) of this section. Where 

a particular combination of industrial 

processing or use operation, sector, and 

function category accounts for less than 


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5 percent of the submitter’s site’s total 

production volume of a reportable 

chemical substance, the percentage 

must not be rounded off to 0 percent. 

Instead, in such a case, submitters must 

report the percentage, rounded off to the 

closest 1 percent, of the submitter’s 

site’s total production volume of the 

reportable chemical substance 

associated with the particular 

combination of industrial processing or 

use operation, sector, and function 

category. 

(5) Site production volume. The 

estimated percentage, rounded off to the 

closest 10 percent, of the submitter’s 

site’s total production volume of the 

PFAS associated with each consumer 

and commercial product category as 

reported in paragraph (c)(4) of this 

section. Where a particular consumer 

and commercial product category 

accounts for less than 5 percent of the 

total production volume of a reportable 

chemical substance, the percentage 

must not be rounded off to 0 percent. 

Instead, in such a case, submitters must 

report the percentage, rounded off to the 

closest 1 percent, of the submitter’s 

site’s total production volume of the 

reportable chemical substance 

associated with the particular consumer 

and commercial product category. 

(6) Site-limited. An indication of 

whether the PFAS was site-limited. 

(7) Volume recycled. The total volume 

(in pounds) of each PFAS recycled onsite. 

(e) Byproduct reporting. A description 

of the byproducts resulting from the 

manufacture, processing, use, or 

disposal of each PFAS. 

(1) Byproduct identification. For each 

byproduct produced from the 

manufacture, processing, use, or 

disposal of a PFAS, the submitter will 

identify the byproduct by its specific, 

currently correct CA Index name as 

used to list the chemical substance on 

the TSCA Inventory and the correct 

corresponding CASRN. A submitter 

under this part may use a known EPAdesignated TSCA Accession Number for 

a chemical substance in lieu of a 

CASRN when a CASRN is not known to 

or reasonably ascertainable by the 

submitter. Submitters who wish to 

report chemical substances listed on the 

confidential portion of the TSCA 

Inventory will need to report the 

chemical substance using a TSCA 

Accession Number. 

(i) In addition to reporting the number 

itself, submitters must specify the type 

of number they are reporting by 

selecting from among the codes in table 

1 to paragraph (b)(1)(ii) of this section. 

(ii) If the specific chemical identity of 

the byproduct is unknown to the 

submitter, the submitter may provide a 

description of the chemical substance. 

(iii) An indication of which specific 

PFAS activity(ies) (i.e., manufacture, 

process, use, or disposal) manufactured 

the byproduct. 

(2) Releases. An indication of whether 

the byproduct is released to the 

environment, and if so, the 

environmental medium to which it is 

released (i.e., air, water, land). 

(3) Volume. For each year, the 

byproduct volume (in pounds) released 

to the environment. 

(f) Environmental and health effects. 

All existing information concerning the 

environmental and health effects of 

such substance or mixture containing a 

chemical substance in the 

manufacturer’s possession or control. 

The scope of this information shall not 

be limited to studies conducted or 

published since 2011. 

(1) Organization for Economic 

Cooperation and Development (OECD) 

Harmonized Templates. For each 

published study report, the submitter 

shall complete an OECD Harmonized 

Templates for Reporting Chemical Test 

Summaries and submit the 

accompanying study reports and 

supporting information. This can be 

accomplished by using the freely 

available IUCLID software. 

(2) Human health data—preliminary 

studies. Submitters shall also provide 

any additional human health data not in 

study reports, including but not limited 

to any preliminary studies, informal test 

results in workers, or inhalation studies. 

(3) Analytical tests. Submitters shall 

also provide the names of any analytical 

or test methods used to detect or 

otherwise test for the PFAS. 

(g) Worker exposure data. The 

number of individuals exposed to PFAS 

in their places of employment and the 

duration of such exposure. 

(1) Employment activities. A narrative 

description of worker activities 

involving the PFAS at the 

manufacturing site, such as bag 

dumping, sampling, cleaning, or 

unloading drums. 

(2) Number of workers. For each 

worker activity in this paragraph, 

indicate the number of workers 

reasonably likely to be exposed. The 

submitter must select from among the 

worker ranges listed in table 7 to this 

paragraph (g)(2) and report the 

corresponding code (i.e., W1 though 

W8). 

TABLE 7 TO PARAGRAPH (g)(2)— 

CODES FOR REPORTING NUMBER OF

WORKERS REASONABLY LIKELY TO

BE EXPOSED

Code Range 

W1 ..... Fewer than 10 workers. 

W2 ..... At least 10 but fewer than 25 workers. 

W3 ..... At least 25 but fewer than 50 workers. 

W4 ..... At least 50 but fewer than 100 workers. 

W5 ..... At least 100 but fewer than 500 

workers. 

W6 ..... At least 500 but fewer than 1,000 

workers. 

W7 ..... At least 1,000 but fewer than 10,000 

workers. 

W8 ..... At least 10,000 workers. 

(3) Exposure scenarios. For each 

worker activity in this paragraph (g), the 

maximum duration of exposure for any 

worker at the manufacturing site, for 

each of the following scenarios: 

(i) The daily exposure duration (in 

hours per day) in the case of the worker 

with greatest annual exposure frequency 

(i.e., the worker exposed the most days 

per year); and 

(ii) The annual exposure frequency (in 

days per year) in the case of the worker 

with greatest daily exposure duration 

(i.e., the worker exposed for the most 

hours per day during the year). 

(4) Exposure by category. For each 

combination of industrial processing or 

use operation, sector, and function 

category identified in paragraph (c) of 

this section, the submitter must estimate 

the number of workers reasonably likely 

to be exposed to each PFAS. For each 

combination associated with each 

chemical substance, the submitter must 

select from among the worker ranges 

listed in table 7 to paragraph (g)(2) of 

this section and report the 

corresponding code (i.e., W1 though 

W8). 

(5) Duration of exposure industrial 

use. For each PFAS, the maximum 

duration of exposure for any worker for 

each combination of industrial 

processing or use operation, sector, and 

function category, for each of the 

following scenarios: 

(i) The daily exposure duration (in 

hours per day) in the case of the worker 

with the greatest annual exposure 

frequency (i.e., the worker exposed the 

most days per year); and 

(ii) The annual exposure frequency (in 

days per year) in the case of the worker 

with the greatest daily exposure 

duration (i.e., the worker exposed for 

the most hours per day during the year). 

(6) Commercial workers. Where the 

PFAS is used in a commercial product, 


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the submitter must estimate the number 

of commercial workers reasonably likely 

to be exposed to each reportable 

chemical substance. For each 

commercial use associated with each 

substance, the submitter must select 

from among the worker ranges listed in 

table 7 to paragraph (g)(2) of this section 

and report the corresponding code (i.e., 

W1 though W8). 

(7) Duration of exposure commercial 

use. For each PFAS, the maximum 

duration of exposure for any worker for 

each commercial use, for each of the 

following scenarios: 

(i) The daily exposure duration (in 

hours per day) in the case of the worker 

with greatest annual exposure frequency 

(i.e., the worker exposed the most days 

per year); and 

(ii) The annual exposure frequency (in 

days per year) in the case of the worker 

with greatest daily exposure duration 

(i.e., the worker exposed for the most 

hours per day during the year). 

(h) Disposal data. During the years in 

which the PFAS was manufactured, the 

manners or methods of its disposal, and 

any changes to the disposal methods or 

processes. 

(1) Categories of disposal methods. 

Description of disposal processes or 

methods, using the appropriate codes in 

table 8 to this paragraph (h)(1), and 

additional descriptions as needed. 

TABLE 8 TO PARAGRAPH (h)(1)— 

CODES FOR REPORTING DISPOSAL

METHODS

Code Disposal method 

D1 ..... On-site land disposal: Resource 

Conservation and Recovery Act 

(RCRA) Class C landfill (hazardous). 

D2 ..... On-site land disposal: other landfill. 

D3 ..... Other on-site land disposal. 

D4 ..... On-site underground injection (UIC). 

D5 ..... Off-site land disposal: RCRA Class 

C landfill (hazardous). 

D6 ..... Off-site land disposal: other landfill. 

D7 ..... On-site incineration. 

D8 ..... Off-site incineration. 

D9 ..... Publicly owned treatment works 

(POTW). 

D10 ... Other off-site waste transfer. 

D11 ... Release to surface water. 

D12 ... Release to air (stack emissions). 

D13 ... Release to air (fugitive emissions). 

D99 ... Other. 

(2) Disposal processes. Describe any 

changes to the disposal process(es) or 

method(s) indicated in paragraph (h)(1) 

of this section for any PFAS 

manufactured since 2011. 

(3) Disposal volume. Indicate total 

volume of the PFAS that was released 

to each environmental medium in each 

year since 2011: land, water, and air. 

(4) Incineration volume. Indicate total 

volume of the PFAS that was 

incinerated on-site in each year since 

2011. If incineration occurred, indicate 

the temperature (in degrees Celsius) at 

which the PFAS was incinerated. If 

incineration occurred at multiple 

temperatures, indicate the minimum 

temperature (in degrees Celsius) at 

which the PFAS was incinerated. 

§ 705.18 Article importer and R&D 

substance reporting options. 

For the one-time submission, certain 

manufacturers have the option to use a 

streamlined reporting form if they do 

not know nor can reasonably ascertain 

information requested under § 705.15, 

beyond what is listed in this part. 

Paragraph (a) of this section lists the 

information which a manufacturer who 

has imported a PFAS within an article 

must report to the extent they know or 

can reasonably ascertain. Paragraph (b) 

of this section lists the information that 

manufacturers of PFAS that are solely 

R&D substances manufactured in 

volumes no greater than 10 kilograms 

per year must report to the extent they 

know or can reasonably ascertain. 

(a) Article reporting. Any importer of 

an article which contains a chemical 

substance that is a PFAS and who meets 

the reporting requirements described in 

§ 705.10 has the option to submit 

information to EPA using a streamlined 

reporting form for that PFAS in the 

imported article, for each year since 

January 1, 2011, in which the PFAS was 

imported in an article. Information must 

be submitted to the extent the submitter 

knows or can reasonably ascertain. In 

the event that actual data is not known 

to or reasonably ascertainable by the 

submitter, then reasonable estimates 

may be submitted. The information 

requested on the streamlined reporting 

form for article importers includes: 

(1) Company and plant site 

information. All company and plant site 

information requested under § 705.15(a) 

shall be reported. 

(2) Chemical-specific information. 

The following chemical-specific 

information must be reported for each 

chemical substance that is a PFAS 

imported in an article, for each year 

since January 1, 2011, in which that 

PFAS was imported within an article. 

(i) The common or trade name, the 

chemical identity, and, except for 

chemical substances that are Class 1 

substances on the TSCA Inventory 

(Inventory), the representative 

molecular structure of each PFAS for 

which such a report is required. 

Submitters who wish to report chemical 

substances listed on the confidential 

portion of the Inventory will need to 

report the chemical substance using a 

TSCA Accession Number. If a submitter 

has a low-volume exemption (LVE) case 

number for the chemical substance, that 

number may also be used if a CASRN 

is not known to or reasonably 

ascertainable by the submitter. In 

addition to reporting the number itself, 

submitters must specify the type of 

number they are reporting by selecting 

from among the codes in table 1 to 

§ 705.15(b)(1)(ii). 

(ii) If the specific chemical identity of 

the PFAS imported in an article is not 

known to or reasonably ascertainable to 

the submitter (e.g., if the chemical 

identity is claimed as confidential 

business information by the submitter’s 

supplier, or if the submitter knows they 

have a PFAS but is unable to ascertain 

its specific chemical identity), the 

submitter may provide a generic name 

or description of the PFAS. 

(3) Categories of use. For each year 

since January 1, 2011, report the 

following information on categories of 

use of each PFAS imported in an article. 

(i) Industrial processing and use 

information. A designation indicating 

the type of industrial processing or use 

operation(s) at each site that receives a 

PFAS from the submitter site directly or 

indirectly (whether the recipient site(s) 

are controlled by the submitter site or 

not). For each PFAS that was imported 

in an article, report the letters which 

correspond to the appropriate 

processing or use operation(s) listed in 

table 2 to § 705.15(c)(1). A particular 

designation may need to be reported 

more than once, to the extent that a 

submitter reports more than one sector 

that applies to a given designation 

under this paragraph (a)(3)(i). 

(ii) Industrial activities sector. A code 

indicating the sector(s) that best 

describe the industrial activities 

associated with each industrial 

processing or use operation reported 

under this section. For each PFAS that 

was imported in an article, report the 

code that corresponds to the appropriate 

sector(s) listed in table 3 to 

§ 705.15(c)(2). A particular sector code 

may need to be reported more than 

once, to the extent that a submitter 

reports more than one function code 

that applies to a given sector code under 

this paragraph (a)(3)(ii). 

(iii) Sector specific function 

categories. For each sector reported 

under paragraph (a)(3)(ii) of this section, 

the applicable code(s) from table 4 to 

§ 705.15(c)(3) must be selected to 

designate the function category(ies) that 

best represents the specific manner in 

which the PFAS in the imported article 

is used. 


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(iv) Consumer and commercial use 

information. Using the applicable codes 

listed in table 5 to § 705.15(c)(4), 

submitters must designate the consumer 

and commercial product category(ies) 

that best describe the consumer and 

commercial products in which each 

PFAS that is in an imported article is 

used (whether the recipient site(s) are 

controlled by the submitter site or not). 

If more than 10 codes apply to a PFAS 

in an imported article, submitters need 

only report the 10 codes for PFAS that 

cumulatively represent the largest 

percentage of the submitter’s production 

volume for that chemical, measured by 

weight. If none of the listed consumer 

and commercial product categories 

accurately describe the consumer and 

commercial products in which each 

PFAS is used, the category ‘‘Other’’ may 

be used, and must include a description 

of the use. 

(v) Product specific function 

categories. For each consumer and 

commercial product category reported 

under paragraph (a)(3)(iv) of this 

section, the applicable code(s) described 

in table 4 to § 705.15(c)(3) must be 

selected to designate the function 

category(ies) that best represents the 

specific manner in which the PFAS in 

an imported article is used. 

(vi) Consumer or commercial use 

designation. Submitters must indicate, 

for each consumer and commercial 

product category reported under 

paragraph (a)(3)(v) of this section, 

whether the use is a consumer or a 

commercial use, or both. 

(vii) In or on consumer products 

intended for children. Submitters must 

determine, within each consumer and 

commercial product category reported 

under paragraph (a)(3)(v) of this section, 

whether any amount of each reportable 

chemical substance manufactured 

(including imported) by the submitter is 

present in (for example, a plasticizer 

chemical substance used to make 

pacifiers) or on (for example, as a 

component in the paint on a toy) any 

consumer products intended for use by 

children age 14 or younger, regardless of 

the concentration of the chemical 

substance remaining in or on the 

product. Submitters must select from 

the following options: The chemical 

substance is used in or on any consumer 

products intended for use by children; 

the chemical substance is not used in or 

on any consumer products intended for 

use by children; or information as to 

whether the chemical substance is used 

in or on any consumer products 

intended for use by children is not 

known to or reasonably ascertainable by 

the submitter. 

(viii) Estimated maximum 

concentration. For each year where the 

PFAS in an imported article is used in 

consumer or commercial products, the 

submitter must report the estimated 

typical maximum concentration, 

measured by weight, of the chemical 

substance in each consumer and 

commercial product category reported 

under paragraph (a)(3)(v) of this section. 

For each PFAS in an imported article in 

each commercial and consumer product 

category reported under paragraph 

(a)(3)(v) of this section, submitters must 

select from among the ranges of 

concentrations listed in table 1 to this 

paragraph (a)(3)(viii) and report the 

corresponding code (i.e., AM1 through 

AM5): 

TABLE 1 TO PARAGRAPH (a)(3)(viii)— 

CODES FOR REPORTING MAXIMUM

CONCENTRATION OF PFAS IN AN IMPORTED ARTICLE

Code Concentration range 

(% weight) 

AM1 ... Less than 0.1% by weight. 

AM2 ... At least 0.1% but less than 1% by 

weight. 

AM3 ... At least 1% but less than 10% by 

weight. 

AM4 ... At least 10% but less than 30% by 

weight. 

AM5 ... At least 30% by weight. 

(4) Imported article production 

volume. For each calendar year since 

January 1, 2011, in which the PFAS was 

imported in an article, the production 

volume of the imported article. The 

imported production volume must be 

reported to two significant figures of 

accuracy. The submitter must also 

provide the unit of measurement of the 

imported production volume by 

selecting among the table 2 to this 

paragraph (a)(4). The submitter must 

also designate, for each PFAS imported 

in an article, whether the imported 

PFAS was ever physically present at the 

reporting site. 

TABLE 2 TO PARAGRAPH (a)(4)— 

CODES TO SPECIFY UNIT OF MEASUREMENT FOR THE IMPORTED ARTICLE PRODUCTION VOLUME

Code Unit of measurement 

LB ...... Pounds. 

TN ..... Tons. 

QT ..... Quantity of imported article. 

O ....... Other (must specify). 

(5) Additional article data. The 

submitter has the option to provide any 

additional information to EPA that is 

requested under § 705.15 on the PFAS 

imported in an article, including 

supplemental attachments. 

(b) Research and development (R&D). 

Any manufacturer of a PFAS R&D 

substance that was manufactured in 

volumes no greater than 10 kilograms 

per year and who meets the reporting 

requirements described in § 705.10 has 

the option to submit information to EPA 

using a streamlined reporting form for 

each such PFAS, for each year since 

January 1, 2011, in which the PFAS was 

manufactured for R&D purposes in 

volumes no greater than 10 kilograms 

per year. Information must be submitted 

to the extent the submitter knows or can 

reasonably ascertain. In the event that 

actual data is not known to or 

reasonably ascertainable by the 

submitter, then reasonable estimates 

may be submitted. The information 

requested on the streamlined reporting 

form for R&D manufacturers includes: 

(1) Company and plant site 

information. All company and plant site 

information requested under § 705.15(a) 

shall be reported. 

(2) Chemical-specific information. 

The following chemical-specific 

information must be reported for each 

R&D chemical substance that is a PFAS 

and each mixture containing a chemical 

substance that is a PFAS and meets the 

requirements for the reporting option 

under this paragraph (b)(2). The 

information must be reported for each 

year since January 1, 2011, in which 

that PFAS was manufactured for R&D 

purposes in quantities no greater than 

10 kilograms per year. 

(i) The common or trade name, the 

chemical identity, and, except for 

chemical substances that are Class 1 

substances on the TSCA Inventory, the 

representative molecular structure of 

each PFAS for which such a report is 

required. Submitters who wish to report 

chemical substances listed on the 

confidential portion of the TSCA 

Inventory will need to report the 

chemical substance using a TSCA 

Accession Number. If a submitter has a 

low-volume exemption (LVE) case 

number for the chemical substance, that 

number may also be used if a CASRN 

is not known to or reasonably 

ascertainable by the submitter. In 

addition to reporting the number itself, 

submitters must specify the type of 

number they are reporting by selecting 

from among the codes in table 1 to 

§ 705.15(b)(1)(ii). 

(ii) If the specific chemical identity of 

the PFAS is not known to or reasonably 

ascertainable to the submitter (e.g., if the 

chemical identity is claimed as 

confidential business information by the 

submitter’s supplier, or if the submitter 

knows they have a PFAS but are unable 


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to ascertain its specific chemical 

identity), the submitter may provide a 

generic name or description of the 

PFAS. 

(3) Production volume. The submitter 

must report for each year since January 

1, 2011, in which the PFAS was 

manufactured, the total annual volume 

(in pounds) of each PFAS domestically 

manufactured or imported at each site. 

The total annual domestically 

manufactured volume (not including 

imported volume) and the total annual 

imported volume must be separately 

reported. These amounts must be 

reported to two significant figures of 

accuracy. 

(i) A designation indicating, for each 

PFAS at each site, whether any 

imported PFAS is ever physically 

present at the reporting site. 

(ii) [Reserved] 

(4) Additional R&D data. The 

submitter has the option to provide any 

additional information to EPA that is 

requested under § 705.15 on the PFAS, 

including supplemental attachments. 

§ 705.20 When to report. 

All information reported to EPA in 

response to the requirements of this part 

must be submitted during the applicable 

submission period. For all reporters 

submitting information pursuant to 

§§ 705.15 and 705.18(b) (research and 

development), the submission period 

shall begin one year following 

November 13, 2023, and last for six 

months: November 12, 2024, through 

May 8, 2025. For any reporter who is 

reporting under this part exclusively 

pursuant to § 705.18(a) (article 

importers), and is also considered a 

small manufacturer under the definition 

at 40 CFR 704.3, the submission period 

shall begin one year following 

November 13, 2023, and last for 12 

months: November 12, 2024, through 

November 10, 2025. 

§ 705.22 Duplicative reporting. 

Any person covered in this part may 

notify EPA through the electronic 

reporting system in § 705.35 that certain 

information has already been submitted 

to EPA, and any such person does not 

need to re-submit the information. The 

notification must include the statutory 

and regulatory provision under which 

the information was submitted and in 

which year it was submitted. This 

ability is limited to the type of 

information listed in this section. If the 

previous submission did not account for 

all information required to be submitted 

pursuant to this part (e.g., due to 

exemptions inapplicable to this part), 

then the person may not rely on that 

prior submission to satisfy the reporting 

requirements of this part. 

(a) Chemical Data Reporting rule. If a 

person identified in § 705.10 has already 

reported certain information in § 705.15 

to EPA pursuant to the Chemical Data 

Reporting rule at 40 CFR part 711, then 

duplicative reporting of that information 

is not required of the years for which 

the information has already been 

reported. Such information that may 

potentially be duplicative under this 

part is limited to: 

(1) Chemical description. Physical 

state of the chemical or mixture 

containing a chemical substance, 

pursuant to 40 CFR 711.15(b)(3)(C)(ix). 

(2) Sector description. Industrial 

processing and use type, sector(s), 

functional category(ies), and percent of 

production volume for each use, 

pursuant to 40 CFR 711.15(b)(4)(i)(A) 

through (D). 

(3) Product category. Consumer and/ 

or commercial indicator, product 

category(ies), functional category(ies), 

percent of production volume for each 

use, indicator for use in products 

intended for children, and maximum 

concentration in the product, pursuant 

to 40 CFR 711.15(b)(4)(ii)(A) through 

(F). 

(4) Workers. Number of workers 

reasonably likely to be exposed for each 

combination of industrial processing or 

use operation, sector, and function, 

pursuant to 40 CFR 711.15(b)(4)(i)(F), 

and the number of commercial workers 

reasonably likely to be exposed when 

the substance is used in a commercial 

product, pursuant to 40 CFR 

711.15(b)(4)(ii)(G). 

(5) Volume. Production volume, both 

domestically manufactured and 

imported, an indicator for the imported 

chemical never physically at site, and 

the volume directly exported, pursuant 

to 40 CFR 711.15(b)(3)(iii) through (v). 

(b) Greenhouse Gas Reporting rule. If 

a person identified in § 705.10 has 

already reported certain information in 

§ 705.15 to EPA pursuant to the 

Greenhouse Gas Reporting rule at 40 

CFR part 98, then duplicative reporting 

of that information is not required of the 

years for which the information has 

already been reported. Such information 

that may potentially be duplicative 

under this part is limited to: 

(1) Imported. Production volume 

(imported), pursuant to 40 CFR 

98.416(c)(1) and (2). 

(2) Exported. Volume directly 

exported, pursuant to 40 CFR 

98.416(d)(1). 

(3) Incinerated. Total volume 

incinerated on-site, pursuant to 40 CFR 

part 98. 

(c) Toxics Release Inventory reporting 

rule. If a person identified in § 705.10 

has already reported certain information 

in § 705.15 to EPA pursuant to the 

Toxics Release Inventory reporting rule 

at 40 CFR part 372, then duplicative 

reporting of that information is not 

required of the years for which the 

information has already been reported. 

Such information that may potentially 

be duplicative under this part is limited 

to: 

(1) Recycled. Total volume recycled 

on-site, pursuant to 40 CFR 

372.85(b)(16). 

(2) Disposal. Description of disposal 

process(es), pursuant to 40 CFR 

372.85(b)(14) and (15). 

(3) Release to land. Total volume 

released to land, pursuant to 40 CFR 

372.85(b)(14)(i)(D) and (E). 

(4) Release to water. Total volume 

released to water, pursuant to 40 CFR 

372.85(b)(14)(i)(C). 

(5) Release to air. Total volume 

released to air, pursuant to 40 CFR 

372.85(b)(14)(i)(A) and (B). 

(6) Incinerated. Total volume 

incinerated on-site, pursuant to 40 CFR 

372.85(b)(16). 

(d) TSCA sections 8(d) and 8(e) 

reporting. If a person identified in 

§ 705.10 has already reported certain 

information in § 705.15(f) to EPA, then 

duplicative reporting of that information 

is not required of the years for which 

the information has already been 

reported. Such information that may 

potentially be duplicative under this 

part is limited to health and safety 

studies submitted pursuant to TSCA 

section 8(d), notification of substantial 

risks pursuant to TSCA section 8(e), or 

other information concerning 

environmental and health effects of the 

PFAS. 

(e) Byproduct reporting. If a person 

identified in § 705.10 must report 

byproducts information pursuant to 

§ 705.15(e), and those byproducts are 

also PFAS that are reported 

independently pursuant to this part, 

then duplicative reporting of the 

environmental releases as byproducts is 

not required. Such information that may 

potentially be duplicative is limited to: 

(1) Incineration. An indication of 

whether the byproduct is released to the 

environment, and if so, the 

environmental medium to which it is 

released (i.e., air, water, land), pursuant 

to § 705.15(e)(2). 

(2) Byproduct volume. For each year, 

the byproduct volume (in pounds) 

released to the environment, pursuant to 

§ 705.15(e)(3). 

(f) Environmental and health effects 

information. If a person identified in 

§ 705.10 has already reported the 


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information in § 705.15(f) to EPA, then 

duplicative reporting of that information 

is not required, except to the extent 

required by to § 705.30. The notification 

required by this paragraph (f) must also 

include the EPA office (e.g., EPA region 

or Headquarters Office) and case 

number or other identifier for the prior 

submission. 

(g) Reporting timeframe. Any person 

covered in this part must report all 

information to EPA in § 705.15 for each 

year since January 1, 2011, in which 

that person manufactured a chemical 

substance that is a PFAS or a mixture 

containing a PFAS. If a person has 

already reported any of the data 

elements identified in paragraph (a) of 

this section, but not for all years since 

2011, then that person must submit the 

required information for the intervening 

years. If a person has already reported 

any of the data elements identified in 

paragraph (a), (b), or (c) of this section, 

and the previous submissions did not 

account for all activities that are 

reportable under this part due to 

exemptions or thresholds that do not 

apply to this part, then that information 

is not considered duplicative reporting, 

and the person must submit information 

for that data element responsive to this 

part. 

§ 705.25 Recordkeeping requirements. 

Each person who is subject to the 

reporting requirements of this part must 

retain records that document any 

information reported to EPA. Relevant 

records must be retained for a period of 

5 years beginning on the last day of the 

submission period. 

§ 705.30 Confidentiality claims. 

(a) Making confidentiality claims—(1) 

Generally. Any person submitting 

information under this part may assert 

a confidentiality claim for that 

information, except for information 

described in paragraph (a)(2) of this 

section. All such confidentiality claims 

must be asserted at the time the 

information is submitted. Instructions 

for asserting confidentiality claims are 

provided in the document identified in 

§ 705.35. Information claimed as 

confidential business information in 

accordance with this section will be 

treated and disclosed in accordance 

with the procedures in 40 CFR part 703 

and TSCA section 14. 

(2) Exceptions. Confidentiality claims 

cannot be asserted for the following: 

(i) Specific chemical identity if the 

chemical is on the public (nonconfidential) TSCA Inventory or 

reported as non-confidential in an LVE; 

(ii) For processing and use data 

elements required by §§ 705.15(c)(1) 

through (7) and 705.18(a)(3)(i) through 

(vii); 

(iii) When a response is left blank or 

designated as ‘‘not known or reasonably 

ascertainable;’’ 

(iv) For specific chemical identity by 

submitters of article importer forms 

described in § 705.18(a); 

(v) For all generic chemical names; 

(vi) For any PFAS that are on the 

public (non-confidential) TSCA 

Inventory, the chemical’s CASRN; 

(vii) For the Inventory Accession 

Numbers for PFAS that are on the 

confidential TSCA Inventory; or, 

(viii) For LVE numbers. 

(3) All existing information 

concerning environmental and health 

effects. (i) Any person submitting a 

health and safety study, or information 

from a healthy and safety study, under 

this part may only assert a 

confidentiality claim for information 

that discloses processes used in the 

manufacturing or processing of a 

chemical substance or mixture or, in the 

case of a mixture, the release of data 

disclosing the portion of the mixture 

comprised by any of the chemical 

substances in the mixture. 

(ii) If any information submitted 

under § 705.15(f) is claimed as 

confidential business information, a 

person who submits the information 

must provide EPA, at the time of 

submission, a sanitized copy for public 

release, removing only that information 

that is claimed as confidential business 

information. 

(iii) Any person who has previously 

submitted information under § 705.15(f) 

and claimed it as confidential business 

information is required to reassert and 

re-substantiate the confidential business 

information claim if they seek to 

maintain the claim of confidential 

business information. Such persons are 

required to submit s a revised sanitized 

copy. 

(b) Substantiation of confidentiality 

claims. (1) Unless exempted, all 

confidentiality claims require 

substantiation at the time of submission 

and must be signed and dated by an 

authorized official. 

(2) Confidentiality claims for the 

following data elements are exempt 

from the substantiation requirement in 

paragraph (b)(1) of this section: 

(i) Volume. Production volume 

information required pursuant to 

§§ 705.15(d)(1), (5), and (6) and 

705.18(a)(4) and (b)(3)(i). 

(ii) Primary submitter. Joint 

submission information from the 

primary submitter, consisting of trade 

name and supplier identification 

required pursuant to § 705.15(b)(1)(i) 

and (ii). 

(iii) Secondary submitter. Joint 

submission information from the 

secondary submitter, consisting of the 

percentage of formulation required 

pursuant to § 705.15(b)(1)(i) and (ii). 

(c) Marking information claimed as 

confidential business information in 

confidentiality substantiation 

documentation. If any of the 

information contained in the answers to 

the questions listed in paragraph (e) of 

this section is asserted to contain 

information that itself is considered to 

be confidential, you must clearly 

identify the information that is claimed 

confidential. 

(d) Certification statement for claims. 

An authorized official representing a 

person asserting a claim of 

confidentiality must certify that the 

submission complies with the 

requirements of this part by signing and 

dating the following certification 

statement: 

‘‘I certify that all claims for confidentiality 

asserted with this submission are true and 

correct, and all information submitted herein 

to substantiate such claims is true and 

correct. Any knowing and willful 

misrepresentation is subject to criminal 

penalty pursuant to 18 U.S.C. 1001. I further 

certify that: (1) I have taken reasonable 

measures to protect the confidentiality of the 

information; (2) I have determined that the 

information is not required to be disclosed or 

otherwise made available to the public under 

any other Federal law; (3) I have a reasonable 

basis to conclude that disclosure of the 

information is likely to cause substantial 

harm to the competitive position of my 

company; and (4) I have a reasonable basis 

to believe that the information is not readily 

discoverable through reverse engineering.’’ 

(e) Substantiation requirements for all 

types of confidentiality claims. For each 

data element that is claimed as 

confidential business information, you 

must submit with your report detailed 

written answers to the following 

questions: 

(1) Substantial harm due to release. 

Please specifically explain what harm to 

the competitive position of your 

business would be likely to result from 

the release of the information claimed as 

confidential business information. How 

would that harm be substantial? Why is 

the substantial harm to your competitive 

position likely (i.e., probable) to be 

caused by release of the information 

rather than just possible? If you claimed 

multiple types of information to be 

confidential (e.g., site information, 

exposure information, environmental 

release information, etc.), explain how 

disclosure of each type of information 

would be likely to cause substantial 

harm to the competitive position of your 

business. (40 CFR 703.5(b)(3)) 


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Federal Register / Vol. 88, No. 195 / Wednesday, October 11, 2023 / Rules and Regulations 70559 

(2) Precautions to protect 

confidentiality. Has your business taken 

precautions to protect the 

confidentiality of the disclosed 

information? If yes, please explain and 

identify the specific measures, 

including but not limited to internal 

controls, that your business has taken to 

protect the information claimed as 

confidential business information. If the 

same or similar information was 

previously reported to EPA as nonconfidential (such as in an earlier 

version of this submission), please 

explain the circumstances of that prior 

submission and reasons for believing 

the information is nonetheless still 

confidential. 

(3) Disclosure under Federal law or 

publicly available information. (i) Is any 

of the information claimed as 

confidential business information 

required to be publicly disclosed under 

any other Federal law? If yes, please 

explain. 

(ii) Does any of the information 

claimed as confidential business 

information otherwise appear in any 

public documents, including (but not 

limited to) safety data sheets; 

advertising or promotional material; 

professional or trade publications; state, 

local, or Federal agency files; or any 

other media or publications available to 

the general public? If yes, please explain 

why the information should be treated 

as confidential. If this chemical is 

patented and the patent reveals the 

information you are claiming to be 

confidential business information, 

please explain your reasons for 

believing the information is nonetheless 

still confidential. 

(4) Duration of claims. Is the claim of 

confidentiality intended to last less than 

10 years (see TSCA section 14(e)(1)(B))? 

If yes, please indicate the number of 

years (between 1–10 years) or the 

specific date after which the claim is 

withdrawn. 

(5) Previously disclosed information. 

Has EPA, another Federal agency, or 

court made any confidentiality 

determination regarding information 

associated with this chemical 

substance? If yes, please provide the 

circumstances associated with the prior 

determination, whether the information 

was found to be entitled to confidential 

treatment, the entity that made the 

decision, and the date of the 

determination. 

(f) Additional requirements for 

specific chemical identity. A person 

may assert a claim of confidentiality for 

the specific chemical identity of a 

chemical substance as described in 

§§ 705.15(b)(1)(i) and 705.18(b)(2)(i) 

only if the identity of that chemical 

substance is treated as confidential in 

the Master Inventory File (or as a 

confidential LVE) as of the time the 

report is submitted for that chemical 

substance, if that substance is currently 

on the Inventory or is an LVE. Any 

person who asserts a claim of 

confidentiality for the specific chemical 

identity under this paragraph must 

provide a generic chemical name. To 

assert a claim of confidentiality for the 

identity of a reportable chemical 

substance, you must submit with the 

report detailed written answers to the 

questions from paragraph (b) of this 

section and to the following questions. 

(1) Chemical substance in U.S. 

commerce. Is this chemical substance 

publicly known (including by your 

competitors) to be in U.S. commerce? If 

yes, please explain why the specific 

chemical identity should still be 

afforded confidential status (e.g., the 

chemical substance is publicly known 

only as being distributed in commerce 

for research and development purposes, 

but no other information about the 

current commercial distribution of the 

chemical substance in the United States 

is publicly available) (40 CFR 

703.5(b)(4)). If no, please complete the 

certification statement: 

‘‘I certify that on the date referenced, I 

searched the internet for the chemical 

substance identity (i.e., by both chemical 

substance name and CASRN). I did not find 

a reference to this chemical substance and 

have no knowledge of public information 

that would indicate that the chemical is 

being manufactured or imported by anyone 

for a commercial purpose in the United 

States. [provide date].’’ 

(2) Leave manufacturing site. Does 

this particular chemical substance leave 

the site of manufacture (including 

import) in any form, e.g., as a product, 

effluent, emission? If yes, please explain 

what measures have been taken to guard 

against the discovery of its identity. 

(3) Chemical identity. If the chemical 

substance leaves the site in a form that 

is available to the public or your 

competitors, can the chemical identity 

be readily discovered by analysis of the 

substance (e.g., product, effluent, 

emission), in light of existing 

technologies and any costs, difficulties, 

or limitations associated with such 

technologies? Please explain why or 

why not. 

(4) Chemical name. Would disclosure 

of the specific chemical name release 

confidential process information? If yes, 

please explain. 

(g) Joint submissions. If a primary 

submitter asks a secondary submitter to 

provide information directly to EPA in 

a joint submission under 

§§ 705.15(b)(1)(i) and 705.18(b)(2)(i), 

only the primary submitter may assert a 

confidentiality claim for the data 

elements that it directly submits to EPA. 

The primary submitter must 

substantiate those claims that are not 

exempt under paragraph (b)(2) of this 

section. The secondary submitter is 

responsible for asserting all 

confidentiality claims for the data 

elements that it submits directly to EPA 

and for substantiating those claims that 

are not exempt under paragraph (b)(3) of 

this section. 

(h) No claim of confidentiality. Except 

for the chemical identity on article 

importer forms submitted under 

§ 705.18(a), information not claimed as 

confidential business information in 

accordance with the requirements of 

this section may be made public (e.g., by 

publication of specific chemical name 

and CASRN on the public portion of the 

TSCA Inventory). EPA will provide 

advance public notice of specific 

chemical identities to be added to the 

public portion of the TSCA Inventory. 

§ 705.35 Electronic reporting. 

You must use CDX to complete and 

submit the reporting form required 

under this part. Submissions may only 

be made as set forth in this section. 

Submissions must be sent electronically 

to EPA via CDX. The information 

submitted and all attachments (unless 

the attachment appears in scientific 

literature) must be in English. All 

information must be true and correct. 

Access the PFAS 8(a)(7) reporting tool 

and instructions, as follows: 

(a) By website. Access the PFAS 

8(a)(7) reporting tool via the CDX 

homepage at https://cdx.epa.gov/ and 

follow the appropriate links. 

(b) By phone or email. Contact the 

EPA TSCA Hotline at (202) 554–1404 or 

TSCA-Hotline@epa.gov. 

[FR Doc. 2023–22094 Filed 10–10–23; 8:45 am] 

BILLING CODE 6560–50–P 


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