TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing 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 proposes to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input. In addition to fulfilling statutory obligations under TSCA, this document will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.

DATES:

Comments must be received on or before August 27, 2021. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0549, using the Federal eRulemaking Portal at http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Stephanie Griffin, Data Gathering and Analysis Division (7401M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1463; email address: griffin.stephanie@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?

You may be potentially affected by this action if you currently or have previously manufactured (defined by statute at 15 U.S.C. 2602(9) to include import) a chemical substance that is a PFAS between January 1, 2011 and the effective date of the final rule. Note that this rule is limited to manufacturers (including importers) of PFAS that are covered as a “chemical substance” under TSCA section 3(2). This rule does not require reporting on substances that are excluded from the definition of “chemical substance” in TSCA section 3(2)(B). Those exclusions include, but are not limited to: Any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; any food, food additive, drug, cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device; tobacco or any tobacco product; any source material, special nuclear material, or byproduct material as such terms are defined in the Atomic Energy Act of 1954; and, any article the sale of which is subject to the tax imposed by Section 4181 of the Internal Revenue Code of 1954. Substances which have been manufactured or imported for intended use as any food, food additive, drug, cosmetic, or device, regulated by the Food and Drug Administration, are not chemical substances under TSCA.

The manufacture of PFAS as a byproduct is not exempt for the purpose of this proposed rule. Unlike TSCA section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, TSCA section 8(a)(7) provides no such exemption. Therefore, this proposed rule under TSCA section 8(a)(7) does not exempt small manufacturers from reporting and recordkeeping requirements. See the discussion under Unit II.D. for further discussion of the inclusion of small manufacturers in this proposed rule. The Agency's previous experience with TSCA section 8(a)(1) collections, as well as the Agency's understanding of disposal and other waste management methods involving PFAS, suggests that most respondents affected by this collection activity may be from the following North American Industrial Classification System (NAICS) code categories:

• NAICS 324—Petroleum and Coal Product Manufacturing;
• NAICS 325—Chemical Manufacturing;
• NAICS 326113—Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing;
• NAICS 327910—Abrasive Product Manufacturing;
• NAICS 333999—All Other Miscellaneous General Purpose Machinery Manufacturing;
• NAICS 334511—Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing;
• NAICS 336111—Automobile Manufacturing;
• NAICS 423510—Metal Service Centers and Other Metal Merchant Wholesalers;
• NAICS 424690—Other Chemical and Allied Products Merchant Wholesalers;
• NAICS 447190—Other Gasoline Stations;
• NAICS 551112—Offices of Other Holding Companies;
• NAICS 562—Waste Management and Remediation Services.

Since other entities may also be affected, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action, but rather has provided a guide to help readers determine whether this document applies to them. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT.

In addition, please note that any use of the term “manufacture” in this document will encompass “import” and the term “manufacturer” will encompass “importer.”

B. What is the Agency's authority for taking this action?

EPA is proposing 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 (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, 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 (also known as confidential business information (CBI)).

C. What action is the Agency taking?

EPA is proposing reporting and recordkeeping requirements under TSCA section 8(a)(7) for PFAS manufactured in any year since January 1, 2011. EPA is providing a comment period during which the public will have the opportunity to comment on this proposed action and its proposed requirements. Commenters are encouraged to provide comments and feedback related to the proposed reporting and recordkeeping requirements presented in this Notification of Proposed Rulemaking (NPRM), including the scope of PFAS covered by the rule (see Unit V. for more discussion on specific items for which the Agency is requesting comments). EPA is providing a comment period of 60 days from the publication date of this NPRM.

D. Why is the Agency taking this action?

The Agency is proposing this action pursuant to TSCA section 8(a)(7) to obtain certain information known to or reasonably ascertainable by manufacturers of PFAS. TSCA section 8(a)(7) requires the Agency to publish a final rule not later than January 1, 2023.

E. What are the incremental economic impacts?

EPA has prepared an economic analysis of the potential impacts associated with this proposed rule (Ref. 13). The primary purpose of this proposed rule is the collection of detailed data on PFAS, as required under TSCA section (8)(a)(7). One potential benefit of this action is the information collected may serve as a basis to better understand potential routes of exposure to PFAS and potential human health and environmental impacts of certain PFAS, among other research needs listed in the Agency's PFAS Action Plan.

The industry is expected to incur one-time burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities. Under the proposed rule, EPA estimates a total industry burden of approximately 122,104 hours, with a cost of approximately $9.8 million. The affected small businesses subject to the proposed rule are expected to incur $1,788,506 in costs for this one-time reporting, with per-firm costs estimated to range from $16,864 to $92,390. The Agency is expected to incur a burden of approximately 7,361 hours and a cost of $948,078. The total social burden and cost are therefore estimated to be approximately 129,465 hours and $10.8 million, respectively (Ref. 13).

F. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email (see the above Addresses section for submitting comments either by mail or hand delivery). Clearly mark the part or all of the information that you claim to be CBI. For confidential information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What is TSCA Section 8(a)?

TSCA section 8(a)(1) authorizes EPA to promulgate rules which require entities, that are not considered small manufacturers or processors, who manufacture, process, or propose to manufacture or process a chemical substance, to maintain such records and submit such reports as the EPA Administrator may reasonably require. Similarly, under those rules, entities who manufacture, process, or propose to manufacture or process a mixture or a chemical substance in small quantities (subject to limitations) must maintain records and submit reports to the extent necessary for the effective enforcement of TSCA.

Under TSCA section 8(a)(2), EPA may require recordkeeping and reporting of the following information:

• The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
• 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.

Under TSCA section 8(a)(7), EPA must promulgate a rule to require each person who has manufactured PFAS in any year since 2011 to report the data described in TSCA section 8(a)(2)(A) through (G) to EPA.

B. What are PFAS?

PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make some of them resistant to degradation and thus highly persistent in the environment (Refs. 1 and 2). Some of these chemicals have been used for decades in a wide variety of consumer and industrial products (Ref. 1). Some PFAS have been detected in wildlife, including higher trophic organisms, indicating that at least some PFAS have the ability to bioaccumulate (Ref. 2). Some PFAS can accumulate in humans and remain in the human body for long periods of time (e.g., months to years) (Refs. 1, 2, and 3). As noted in EPA's PFAS Action Plan (Ref. 1), because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS. As a result, several PFAS have been detected in human blood serum (Refs. 1, 2, 3, and 4).

Under TSCA section 8(b), EPA maintains the TSCA Chemical Substance Inventory (“Inventory”), which contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA (Ref. 5). EPA has identified 1,346 PFAS on the Inventory as of April 2021, 669 of which are on the active Inventory (i.e., in U.S. commerce). The list of active chemicals includes those known to be in commerce after June 2006.

C. What would be the reporting standard?

EPA is proposing that manufacturers will report information to the extent that the information is known to or reasonably ascertainable by the manufacturer (see TSCA section 8(b)(2)). “Known to or reasonably ascertainable by” would be 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.” This reporting standard would require 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 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 or a supplier notification; and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet (D-U-N-S). This information may also include knowledge gained through discussions, conferences, and technical publications. This definition is identical to the definition of the same term at 40 CFR 704.3. In addition, this is the same reporting standard employed in the TSCA section 8(a) Chemical Data Reporting (CDR) rule (see 40 CFR 711.15). EPA has also provided CDR reporting guidance materials on this reporting standard, including hypothetical examples of applying the “known to or reasonably ascertainable by” reporting standard in the context of collecting processing and use data for CDR (Ref. 6, pages 45-47). Therefore, EPA anticipates many reporters under this proposed rule will be familiar with this reporting standard, and resources are available to support those reporters who may not be familiar with the standard. EPA acknowledges that it is possible that an importer, particularly an importer of articles containing PFAS, may not have knowledge that they have imported PFAS and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described in this paragraph. Such an importer should document its activities to support any claims it might need to make related to due diligence.

In the event that a manufacturer does not have actual data (e.g., measurements or monitoring data) to report to EPA, the manufacturer would be required to make “reasonable estimates” of such information. “Reasonable estimates” may rely, for example, on approaches such as mass balance calculations, emissions factors, or best engineering judgment.

D. Why are small businesses not excluded from reporting similar to Chemical Data Reporting (CDR) and other section 8(a) reporting?

Unlike TSCA section 8(a)(1), which provides an express exemption for small manufacturers and processors, TSCA section 8(a)(7) specifically states that “each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance” shall be subject to the rule. Rather than amend TSCA section 8(a)(1), Congress chose to add an entirely new, standalone subsection to TSCA section 8(a). This indicates an intent for TSCA section 8(a)(7) to constitute separate, freestanding rulemaking authority; therefore, it is not constrained by requirements and provisions in TSCA section 8(a)(1).

However, in carrying out TSCA section 8, EPA shall, to the extent feasible: (A) Not require reporting which is unnecessary or duplicative; (B) Minimize the cost of compliance with TSCA section 8 and the rules issued thereunder on small manufacturers and processors; and (C) Apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this subchapter (TSCA section 8(a)(5)).

E. How will EPA use the information?

TSCA section 8(a)(7) is silent on how the information collected under the TSCA section 8(a)(7) rule is to be used. However, collecting information on PFAS identities, uses, production volumes by category of use, byproducts, environmental and health effects, workers exposure, and disposal supports the Agency's mission in the PFAS Action Plan to identify and better understand these chemicals and to increase scientific research on them.

EPA intends to use information on these chemicals to support assessments of new and existing chemicals under TSCA. For instance, information collected under this proposed rule will help inform future assessments of potential exposure to these PFAS. The Agency would also benefit from receiving all existing information related to human health and environmental effects of such substances, in order to fulfill additional environmental protection mandates beyond the TSCA program. For instance, information on PFAS use, exposure, and effects may be used to inform regulatory activities under the Safe Drinking Water Act (42 U.S.C. 300f et seq.), the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq.), and the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq.), while data on PFAS manufacturing sites and disposal methods may support contaminants characterizations conducted to support contaminated site work and solid waste management programs.

Additionally, TSCA section 9(e) requires the EPA Administrator to make information related to exposure or releases available to other EPA offices or federal agencies if such exposures may be prevented or reduced under another law. EPA may share such information collected under this proposed rule as appropriate.

III. Summary of Proposed Reporting and Recordkeeping Requirements

EPA is proposing reporting and recordkeeping requirements for manufacturers of PFAS pursuant to TSCA section 8(a)(7).

A. What chemical substances would be reportable under this rule?

1. Reportable chemicals substances. Under TSCA section 8(a)(7), EPA must collect information on chemical substances that are “perfluoroalkyl or polyfluoroalkyl” substances or PFAS. EPA has determined that any PFAS that fall within the structural definition, described below, are the PFAS referred to in TSCA section 8(a)(7). For this proposed rule, EPA has identified at least 1,364 chemical substances and mixtures that are PFAS and would potentially be subject to reporting under the final rule, if they have been manufactured in any year since January 1, 2011.

For the purposes of this proposed action, the structural definition of PFAS includes 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. It should be noted that this structural definition of PFAS is a working definition which has been used by EPA's Office of Pollution Prevention and Toxics when identifying PFAS on the TSCA Inventory. This definition may not be identical to other definitions of PFAS used within EPA and/or other organizations. To assist potential reporters with determining whether certain substances may be covered under this structural definition, EPA has identified specific PFAS covered by this proposed rule. These will be included as non-exhaustive examples in the rule where it is possible to do so without divulging information claimed as CBI. The scope of PFAS examples listed in this proposal includes:

• All PFAS listed as active on the TSCA Inventory. This includes PFAS that are identified by CAS number; confidential chemicals whose generic names contain “fluor” and are identified by Accession number; and confidential chemicals whose generic names do not contain “fluor”, and therefore, are not listed by CASRNs, Accession numbers, or low-volume exemptions (LVE) case numbers (see note on structural diagram examples below).
• All PFAS that are subject to TSCA section 5 (new chemicals) LVE applications per 40 CFR 723.50 that have been granted by EPA. This includes the PFAS that were subject to granted LVE applications that have since been withdrawn by the LVE application submitter. Additional discussion on LVEs is below.

Under TSCA section 5, any person who intends to manufacture a chemical not on the TSCA Inventory must first notify EPA. Typically, this is done by submission of a premanufacture notice (PMN) (Ref. 8). However, for low-volume chemical substances (i.e., chemical substances manufactured at no more than 10,000 kg per year) companies can submit a LVE application to EPA per 40 CFR 723.50. EPA may either grant or deny an LVE submission after review, but LVEs that are granted are not listed on the Inventory, unlike PMN chemical substances. Therefore, EPA is also providing a list of PFAS chemicals for which EPA granted an LVE notice.

LVE submitters may choose to withdraw their granted LVE application. In order to compile a comprehensive dataset as authorized under TSCA section 8(a)(7), EPA is including these withdrawn LVE submissions in the list of examples subject to this proposed rule if they were submitted since 2011.

• This proposed rule will also include structural diagrams to capture any PFAS whose CAS or Accession numbers could not be divulged due to CBI claims, whose identity is not listed on the TSCA Inventory because it is subject to an LVE, or which is a byproduct not listed on the Inventory and not subject to an LVE, yet meets the structural definition. The list of identified PFAS and structural diagrams can also be found in the docket (Ref. 7). The PFAS included in the list and identified by the structural diagrams are examples of substances that meet this rule's definition of PFAS; it is not a comprehensive list of all substances within this rule's scope.

EPA is providing these examples of PFAS for the purpose of assisting manufacturers in determining whether a chemical substance they have manufactured in any year since 2011 meets this proposed rule's definition of PFAS. Because the Inventory's active designation dates back to June 2006, it is possible for a firm to have manufactured one of these listed PFAS yet not be required to report under this proposed rule, if they have manufactured it only in the period prior to January 1, 2011.

This list was developed as of April 2021. EPA anticipates updating this list prior to promulgating the final rule, both in response to public comment, and as a result of PMNs added to the Inventory and LVEs granted by EPA between April 2021 and the date of publication of the final rule.

For the purposes of this proposed rule, articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings), are included in the scope of reportable chemical substances. TSCA does not define articles, nor does the statute define articles as a category of substances exclusive of chemical substances. EPA therefore considers its ability to regulate chemical substances to encompass authority to regulate articles containing such chemical substances. Additionally, the Agency would benefit from collecting the requested information on PFAS-containing articles (including articles containing PFAS as part of surface coatings) because the information would improve the Agency's knowledge of various products which may contain PFAS, their categories of use, production volumes, and exposure data. Such data are not currently known to EPA. However, EPA acknowledges that some article manufacturers, including article importers, may not have such information known to or reasonably ascertainable by them and may not meet the reporting standard as described in Unit II.C. To this end, information that helps EPA better understand data gaps is useful information for EPA to have. Therefore, articles are within the scope of reportable substances under this proposed rule, though EPA is requesting comments on whether imported articles containing PFAS should be within scope (see Unit IV.1).

2. Proposed exceptions to reporting for duplicative reporting. TSCA section 8(a)(5) 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 developing this rule EPA reviewed the data elements submitted under the Chemical Data Reporting Rule and determined that there may be some overlap with the information requested under the proposed rule. EPA is proposing to allow reporting entities to indicate in the reporting tool that they have previously provided such information to EPA through CDR for certain data elements. The Agency has identified the following data elements which the reporter may be able to indicate has already been submitted to EPA:

• Physical state of the chemical or mixture;
• 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.

If a manufacturer covered under this proposed rule has previously submitted required information to EPA for some years since 2011, but not for all years, EPA is proposing that the manufacturer may indicate in the reporting tool the year(s) for which the manufacturer has already submitted that data to EPA as part of CDR. For instance, CDR reporters are required to 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 reporting only the combined total annual production volume is required for the intervening years. In this case, a reporter under this proposed rule would be able to indicate that the two different production volumes have been previously submitted to EPA for the CDR reporting year(s), but would still need to report for the intervening year(s) not previously submitted under CDR. Additionally, there are some data elements for which CDR reporters may have previously reported information to EPA, although these data elements were only added to the CDR reporting requirements in 2020. Therefore, some manufacturers under this proposed rule may have submitted the following information to CDR for some years covered by this proposed rule, but not all, and would still be required to report this information for the missing year(s):

• Domestically manufactured production volume;
• Imported production volume;
• Volume directly exported; and
• Indicator for imported but never physically at site.

EPA welcomes public comment on concerns related to duplicative reporting (see Unit V.).

B. When would reporting be required?

EPA proposes that persons who have manufactured a PFAS at any time since January 1, 2011, would report to EPA during a six-month submission period, which would begin six months following the effective date of the final rule. Therefore, manufacturers would ultimately have one year following the effective date of the final rule to collect and submit all required information to EPA. EPA believes by providing six months between the effective date of the rule and the start of the submission period, this would allow sufficient time for both the Agency to finalize the reporting tool and for reporters to familiarize themselves with the rule and compile the required information. Since this section 8(a)(7) reporting rule will be collecting similar information as CDR, EPA anticipates many reporters will be familiar with the types of information requested and how to report. The CDR submission period is four months, every four years. Since this proposed rule spans a longer time than the four-year CDR reporting cycle, EPA acknowledges additional time may be needed in the PFAS submission period. EPA believes that six months is adequate time for submissions, in addition to the six-month period between the effective date and the start of the submission period.

EPA is also asking for public comment on the submission period start date and duration (see Unit V.).

C. What information would be reported?

TSCA section 8(a)(7) specifies that, under the final rule, manufacturers would report on “information described in subparagraphs (A) through (G) of paragraph (2) [of section 8].” Therefore, this TSCA section 8(a)(7) rule proposes one-time reporting of the information described in section 8(a)(2)(A) through (G), which includes specific chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal.

Specifically, EPA is proposing to request the following information:

1. Chemical name (multiple if mixture), or the generic name(s) if the chemical name(s) is CBI.

2. Chemical ID(s) (CASRN, TSCA Accession Number, or LVE case number).

3. Trade name or common name.

4. Representative molecular structure.

5. Physical form of chemical or mixture.

6. Industrial processing and use:

a. Type of process or use;

b. Sector(s);

c. Functional use category(ies);

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; functional use category(ies);

c. Percent production volume for each use; maximum concentration in any product;

d. Indicator for use in products intended for children.

8. Production volumes:

a. Domestically manufactured;

b. Imported;

c. Directly exported;

d. Maximum first 12 months production volume;

e. Maximum yearly production volume in any 3 years.

9. Indicator for imported but never physically at site.

10. Indicator for site-limited.

11. Maximum quantity stored on-site at any time.

12. Total volume recycled (on-site).

13. For byproducts produced during the manufacture, processing, use, or disposal of each PFAS:

a. Chemical name(s) or description (if identity is unknown), or the generic name(s) if the byproduct name(s) is CBI;

b. Chemical ID(s) (CASRN, TSCA Accession Number, or LVE case number);

c. Indicator for whether the byproduct(s) production resulted from manufacture, process, use, or disposal; and

d. Indicator for whether the byproduct(s) is released to the environment; if so, volume of byproduct(s) released and to which environmental media.

14. Worker exposure: Description of worker activity(ies) at manufacturing site.

15. Worker exposure at the manufacturing site:

a. Number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity;

b. Maximum duration of exposure for any worker, for each worker activity (both hours per day and days per year).

16. Worker exposure for each industrial process and use:

a. Number of workers reasonably likely to be exposed for each industrial process and use;

b. Maximum duration of exposure for any worker for each industrial process and use (both hours per day and days per year).

17. Worker exposure for each commercial use:

a. Number of workers reasonably likely to be exposed for each commercial use;

b. Maximum duration of exposure for any worker for each commercial use (both hours per day and days per year).

18. Description of disposal process(es), and description of any changes to the disposal process or methods since 2011.

19. Total volume released:

a. Land disposal;

b. Water releases;

c. Air releases.

20. Total volume incinerated (on-site) and incineration temperature.

21. All existing information related to health and environmental effects, using the Organization of Economic Cooperation and Development (OECD) harmonized template relevant to the existing study, as well as full study reports and any other supporting information (for additional information on the use of the OECD harmonized templates, see the discussion in the following section, Unit III.D.).

22. Other data relevant to health and environmental effects (e.g., range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports).

A list of the proposed reporting requirements is available in the docket for public review (Ref. 10).

EPA developed an information reporting platform for CDR (Ref. 9) and intends to modify it for purposes of this proposed rule. Certain information that is requested in the CDR that falls under TSCA section 8(a)(2)(A) through (G) would be required by this proposed rule, such as information on specific chemical identity, categories of use, production volume, byproducts, and number of persons exposed and duration of exposure (see Unit III.A.2. for the discussion on duplicative reporting). In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA, they will not be required to re-report. As discussed in Unit III.A.2, EPA is proposing the reporters simply indicate they have already submitted such information to EPA.

Additionally, any person required to report under this proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them, or a reasonable estimate when actual data are not available (i.e., known or reasonably ascertainable), as explained in more detail in Unit II.D.

D. What type of environmental and health effects information is the Agency requesting?

EPA is requesting “all existing information concerning the environmental and health effects” of the PFAS chemicals covered by this rule. It is intended that “environmental and health effects information” be interpreted broadly. This information would include but is not limited to:

• Toxicity information (e.g., in silico, in vitro, animal test results, human data); and
• Other data relevant to environmental and health effects including range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports.

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.

EPA is proposing to require all existing information concerning health and environmental effects be submitted in the format of OECD harmonized templates, where such templates exist for the type of data, in addition to submitting full study reports. OECD templates are accessible to the public online at https://www.oecd.org/ehs/templates/harmonised-templates.htm (Ref. 11). 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 in the OECD template if the company had already submitted the studies under the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. 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 if data were to be used for any future Agency actions.

EPA is requesting comments on what environmental and health effects information should be within the scope of this rule. EPA is also requesting comment on whether any information proposed to be requested is duplicative of information collected by EPA under other federal statutes and, thus, should be excluded. Please identify the information that you believe is duplicative and the statute under which it is submitted.

E. How would information be submitted to EPA?

EPA is proposing to require electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 40 CFR 704.20(e)). EPA is proposing to require submitters to use EPA's CDX, the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d) (Ref. 12, page 72818). The final rule followed two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA CDR and for PMNs. In proposing to require similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency.

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), 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. Submitted information is rendered into PDF and XML formats, which are provided to submitters in the form of a Copy of Record.

EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPA's CDX and use CISS to prepare a data file for submission. Registration enables CDX to authenticate user identity. To submit electronically to EPA via CDX, individuals must first register with CDX at http://cdx.epa.gov/. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at https://cdx.epa.gov/FAQ#CSPP.

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, CDR, or reporting under the TSCA Inventory Notification (Active-Inactive) Requirements rule (82 FR 37520, Aug. 11, 2017) (FRL-9964-22), 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.

All submitters would be required to use CISS to prepare their submissions. CISS guides users through a “hands-on” process of creating an electronic submission. Once a user completes the relevant data fields and attaches appropriate PDF files, or other file types, such as XML files, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.

CISS, a web-based reporting tool, also allows the user to choose to “Preview,” “Save,” or “Submit” the data package. Once the submission process is initiated, the user is asked to certify the information and provide requested information to complete the submission process. The data package is then sent, in an encrypted state, to the Agency. The user can login to the application and check the submission status of their data package. Upon successful receipt of the submission by EPA, the submission status of the submissions will be flagged as “Completed” and a confirmation email will be sent to the submitter's CDX inbox. The CDX inbox is used to notify the users when submissions are received by EPA or to notify users when a submission-specific communication has been received and how to locate and access the communication. Information on accessing the CDX user inbox is provided in the guidance document for CDX at https://cdx.epa.gov/FAQ#CSPP. To access CISS log into CDX using the link: https://cdx.epa.gov/ and click on the appropriate user role associated with the CSPP data flow. For further instructions, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information (Ref. 12). Procedures for reporting chemical substances under this proposed rule would be similar.

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 proposed rule have experience with reporting electronically to EPA through 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. EPA expects to benefit from receiving electronic submissions and communicating electronically with submitters.

F. What can a submitter claim as confidential?

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. The Agency recently finalized a rule amending the CDR reporting requirements that implemented the new requirements for confidentiality claims in CDR submissions (Ref. 13). EPA is similarly proposing that a person submitting a reporting form under this action may claim portions of the form as confidential, consistent with TSCA section 14. TSCA requires that the submitter make several statements relating to the treatment of the information as confidential and competitive harm of disclosure, and to certify that these statements and any substantiation 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. There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided. To help reporters, EPA's reporting platform can auto-populate generic names on the Inventory using EPA's Substance Registry Services (SRS).

TSCA section 14 further requires that substantiation be provided when a confidentiality claim is asserted. However, TSCA section 14(c)(2) exempts certain information from the substantiation requirements (e.g., specific production volume). Under the proposed rule, specific production or import volumes of the manufacturer, as well as the percent production volume for each consumer or commercial use, need not be substantiated. All other information submitted under this proposed rule would not be exempt from substantiation requirements.

Any information which is claimed as confidential will be disclosed by EPA only in accordance with the procedures and requirements of TSCA section 14 and 40 CFR part 2. TSCA limits confidentiality protections for health and safety studies, 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”), and certain other information. Submitters asserting a confidentiality claim for such information in health and safety studies will be required to submit a sanitized copy of the study, removing only that information which is claimed as confidential and that discloses the process or portion of mixture information described in TSCA section 14(b).

G. What are the recordkeeping requirements?

EPA proposes that each person who is subject to the reporting requirements must retain records that document any information reported to EPA. Consistent with the CDR rule, EPA is proposing a five-year recordkeeping period, beginning on the last date of the submission period. The five-year retention requirement corresponds with the statute of limitations for violations and is necessary to preserve records to support future regulatory activities that would be informed by this information collection. Further, EPA believes the burden of retaining these records, which are likely electronic, is minimal.

IV. Request for Comments

EPA is seeking public comment on all aspects of this proposed rule and the Economic Analysis prepared in support of this proposed rule (Ref. 14). In addition to specific requests for comment included throughout this document, EPA is interested in comments pertaining to the specific issues discussed in this unit. EPA encourages all interested persons to submit comments on the issues identified in this Notification and to identify any other relevant issues as well. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.

1. Identifying the chemical substances that would be subject to reporting. EPA has provided a structural definition of PFAS for the purposes of this proposed rule's scope. To assist reporting entities with determining whether a chemical substance or mixture falls within this scope, EPA has also provided a list of PFAS (identified by CASRN, TSCA Accession Number, or LVE case number) and structural diagrams to include any PFAS whose chemical identity is not specifically listed due to CBI protections. EPA is soliciting comment on this approach for defining or identifying PFAS. Additionally, EPA is interested in comments identifying specific substances of interest and the rationale for the interest, that may be outside the scope of this proposed definition. EPA is also interested in public comments related to including imported articles containing PFAS within the scope of this proposed rule.

2. Considerations for the Agency's economic analysis. EPA has evaluated the potential costs for PFAS manufacturers for this proposed rule (Ref. 14). EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis. In particular, EPA is seeking data that could facilitate the Agency's further evaluation of the potentially affected industry and firms, including data related to potential impacts for those small businesses and importers that would be subject to reporting. The agency is specifically interested in available data on small entity importers of articles containing PFAS for its impact analysis for small entities. EPA is also especially interested in available data or other measures of the number of facilities or firms that might manufacture such materials, including importing PFAS in articles.

3. Submission period. EPA is proposing a six-month submission period for reporting entities, which will begin six months following the effective date of the final rule. Thus, PFAS manufacturers will have one year following the effective date of the final rule to submit all required information to EPA. Since many of the reporters under this proposed rule have reported under CDR, EPA is basing the proposed submission period, in part, on the CDR submission period. Given the four-month submission period for the CDR reporting cycle every four years, the Agency believes six months is sufficient time for manufacturers to report the required information under this proposed rule, noting that the scope of this rule covers more years than a CDR reporting cycle. Reporters will also have the additional six months between the effective date of the rule and the start of the submission period for rule familiarization and data gathering. Additionally, the six months between the effective date of the final rule and the beginning of the submission period allows the Agency time to finalize the reporting software. Congress required EPA to promulgate the rule no later than January 1, 2023; therefore, EPA anticipates the reporting period for this proposed rule will precede the reporting period for the 2024 CDR reporting cycle (June-September 2024). EPA is specifically asking for comment on additional considerations related to the start date and duration of the submission period.

4. Duplicative reporting. EPA has identified the data elements in this proposed rule for which information may have been submitted to EPA previously under CDR (see Unit III.D.), which the Agency is proposing to allow manufacturers to indicate through the reporting tool has already been submitted rather than re-submit the information. EPA is requesting comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes. Please identify the information that you believe is duplicative and the statute under which it is submitted, as well as the precision of the information if appropriate (for example, whether the data are submitted as a range or as an integer to the nearest significant digits).

5. Scope of environmental and health effects information collected. EPA is requesting comment on what existing environmental and health effects information should be within the scope of this rule. EPA is proposing to require such information be submitted in the form of OECD harmonized templates, to the extent they are available, and as full study reports and any supporting documents. The Agency is requesting comments on the scope of existing environmental and health information that may be requested from PFAS manufacturers. The Agency is also interested in comments on the proposed format of these submissions.

6. Additional information or data elements. EPA has provided the list of proposed data elements for this rule in Unit III.C (Ref. 10), which EPA is authorized to request under section 8(a)(7). EPA is interested in public comment on the scope of these proposed data elements, including whether there are additional data elements EPA should collect under the authority of section 8(a)(7). Specifically, EPA is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to reasonably ascertain the specific PFAS identity. The Agency is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational non-users (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical).

7. EPA's use and publication of certain non-CBI data. EPA is requesting public comment on how the Agency may consider using the data received under this reporting rule, beyond those activities previously mentioned in Unit II.E. Additionally, the Agency is interested in comment on the extent to which non-CBI data submitted under this rule should be provided to the general public.

8. Joint submissions. EPA is requesting public comment on whether the Agency should enable the use of joint submissions in specific circumstances, similar to CDR joint submissions. Joint submissions may be necessary under circumstances when: (1) A company imports a chemical or a mixture under a trade name and the substance identity, or individual components, are not known to the importer, or (2) a manufacturer cannot provide the entire chemical identity of a chemical substance it manufactures because the chemical substance is manufactured using a reactant having an identity that the reactant supplier claims as confidential. In these circumstances, the supplier has identified that it will not disclose to the manufacturer (or importer) or does not, itself, know the chemical identity.

9. Small manufacturers. EPA is requesting public comment on how the Agency may assist small manufacturers with compliance with this proposed rule. The Agency appreciates comments related to both regulatory and non-regulatory assistance, such as different reporting timelines and outreach.

V. References

The following is a list 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 (2019). EPA's Per- and Polyfluoroalkyl Substances (PFAS) Action Plan, EPA-823R-18-004. February 14, 2019. Available at https://www.epa.gov/sites/production/files/2019-02/documents/pfas_action_plan_021319_508compliant_1.pdf.

2. EPA (2017). Technical Fact Sheet—Perfluorooctane Sulfonate (PFOS) and Perfluorooctanoic Acid (PFOA), EPA 505-F-17-001. November 2017. Available at https://www.epa.gov/sites/production/files/2017-12/documents/ffrrofactsheet_contaminants_pfos_pfoa_11-20-17_508_0.pdf.

3. EPA (2009). Long-Chain Perfluorinated Chemicals (PFCs) Action Plan. December 30, 2009. Available at https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.

4. ATSDR (2018). Toxicology Profile for Perfluoroalkyls. June 2018. Available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

5. EPA. TSCA Chemical Substance Inventory. (No date). Available at https://www.epa.gov/tsca-inventory. [Accessed November 12, 2020].

6. EPA. Instructions for Reporting: 2020 TSCA Chemical Data Reporting. November 2020. Available at https://www.epa.gov/sites/production/files/2020-12/documents/instructions_for_reporting_2020_tsca_cdr_2020-11-25.pdf.

7. EPA. Examples of PFAS and Structural Diagrams included in the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS. October 2020.

8. EPA. Filing a Pre-manufacture Notice with EPA. (No date). Available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-pre-manufacture-notice-epa. [Accessed November 12, 2020].

9. EPA (2020). CDX Chemical Safety and Pesticide Programs (CSPP) Registration User Guide; Version 3.02. March 6, 2020. Available at https://www.epa.gov/chemical-data-reporting/cspp-cdx-registration-guide.

10. EPA. Data Elements included in the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS. October 2020.

11. OECD. OECD Harmonised Templates. (No date). Available at https://www.oecd.org/ehs/templates/harmonised-templates.htm. [Accessed November 12, 2020].

12. EPA (2013). Electronic Reporting under the Toxic Substances Control Act; Final Rule. (78 FR 72818, December 4, 2013) (FRL-9394-6).

13. EPA (2020). TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a); Final Rule. (85 FR 20122, April 9, 2020) (FRL-10005-56).

14. EPA (2020). Economic Analysis for the Proposed Rule for Reporting and Recordkeeping Requirements for PFAS. November 2020.

15. EPA (2020). Information Collection Request Supporting Statement. Proposed Rule ICR: Reporting and Recordkeeping Requirements for PFAS. EPA ICR No. 2682.01. November 2020.

VII. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). EPA prepared an analysis of the estimated costs and benefits associated with this action (Ref. 13), which is available in the docket and is summarized in Unit I.E. Any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of Executive Order 12866.

B. Paperwork Reduction Act (PRA)

The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2682.01 (Ref. 15). You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.

The reporting requirements identified in the proposed rule would 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 proposed reporting requirements would 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 proposed 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: Manufacturers (including importers) of PFAS since January 1, 2011.

Respondent's obligation to respond: Mandatory (15 U.S.C. 2607(a)(7)).

Estimated number of respondents: 234.

Frequency of response: Once.

Total estimated burden: 122,104 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $9,820,813 (per year), 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.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to oira_submissions@omb.eop.gov, Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than July 28, 2021. The EPA will respond to any ICR-related comments in the final rule.

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq.). The small entities subject to the requirements of this action are manufacturers (including importers) of PFAS. EPA estimates that 59 small firms would be affected by the proposed rule. Of those small firms, 46% would have cost impacts of less than 1% of annual revenues, 19% would have impacts between 1-3%, and 35% would have impacts of more than 3% of annual revenues. The affected small businesses subject to the proposed rule are expected to incur $1,788,506 in costs for this one-time reporting, with per-firm costs estimated to range from $16,864 to $92,390. However, EPA is unable to estimate the number of small entity importers of articles that are subject to this proposed rule due to a lack of available data on importers of articles containing PFAS. Imported articles are exempt from the CDR Rule under 40 CFR 711.10(b). Similarly, under TRI reporting, listed toxic chemicals contained in articles that are processed or otherwise used at a covered facility are exempt from reporting threshold determinations and release and other waste management calculations. EPA is unaware of publicly available data that provides the information on the article importers needed to develop the estimates. Without available data, EPA does not have a representative subset of firms to reference as a basis for estimates and thus cannot estimate the number of importers of articles that will be affected.

However, EPA expects that article importers may incur a range of costs depending on the number of articles they import, their level of knowledge of their imported articles, the complexity of supply chains, and whether PFAS is present in their articles. Importers of articles that contain PFAS may incur costs for rule familiarization ($69.79 per firm); identifying the type of imported articles that potentially use PFAS ($1,641-$1,932 per firm); identifying suppliers involved ($1,185 per firm); collecting data from suppliers ($0-644 per article); and recordkeeping ($12 per firm). Details of this analysis are presented in the Economic Analysis of the proposed rule (Ref. 14), which is available in the docket.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The requirements of this action would primarily affect manufacturers (including importers) of PFAS. The total quantified one-time costs of the proposed rule are approximately $9.8 million.

E. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the 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). 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. Thus, E.O. 13175 does not apply to this action.

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 the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not a covered regulatory action because it is not “economically significant” under Executive Order 12866 and it does not concern an environmental health risk or safety risk. Although this action would not establish an environmental standard intended to mitigate health or safety risks, the information that would be submitted to EPA in accordance with this proposed rule would be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information may also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, which would allow the Agency and others to take appropriate action to investigate and mitigate those risks.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, 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 and has not otherwise been designated by the Administrator of OMB's Office of Information and Regulatory Affairs as a “significant energy action.”

I. National Technology Transfer and Advancement Act (NTTAA)

Because this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

The requirements of the proposed rule are directed at manufacturers (including importers) of PFAS chemicals for which basic production, use, and toxicity information is currently unavailable. The costs and the benefits of the proposed rule would not be disproportionately distributed across different geographic regions or among different categories of individuals. Consumers of these chemical products, workers who come into contact with these chemical substances, and communities neighboring PFAS manufacturing sites could benefit from EPA's assessment of information required under the proposed rule. The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with PFAS chemicals. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.

List of Subjects in 40 CFR Part 705

• Chemicals
• Environmental protection
• Hazardous Materials
• Recordkeeping, and Reporting Requirements

Therefore, for the reasons stated in the preamble, the Environmental Protection Agency proposes to amend 40 CFR chapter I by adding part 705 to read as follows:

PART 705—REPORTING AND RECORDKEEPING REQUIREMENTS FOR CERTAIN PER- AND POLYFLUOROALKYL SUBSTANCES

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