(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.

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;

(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 lower-level 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 non-Federal 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 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.

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.

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.

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.

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).

(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 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).

(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).

(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.

(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.

(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):

(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 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 on-site.

(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 EPA-designated 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 unpublished 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).

(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, 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.

(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.

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.

(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):

(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.

(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 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.

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 on July 11, 2025, and last for six months: July 11, 2025, through January 11, 2026. 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 on July 11, 2025, and last for 12 months: July 11, 2025, through July 11, 2026.

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 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.

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.

(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 (non-confidential) 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:

(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))

(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 non-confidential (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:

(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.

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 [email protected].