PFAS Reporting in USA

Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances

SUPPLEMENTARY INFORMATION:

I. Executive Summary

• A. Does this action apply to me?
• This action may apply to you if you have manufactured (including import) PFAS for commercial purposes since January 1, 2011.
• Reference: 15 U.S.C. 2602(9).
• Potentially affected NAICS codes:
• Construction (23)
• Manufacturing (31-33)
• Wholesale trade (42)
• Retail trade (44-45)
• Waste management and remediation services (562).
• Refer to 40 CFR 705.10 and 40 CFR 705.12 for detailed applicability.
• For more information, consult the FOR FURTHER INFORMATION CONTACT section.
• B. What is TSCA section 8(a)(7)?
• Signed into law on December 20, 2019, within the National Defense Authorization Act for Fiscal Year 2020 (NDAA, PL 116-92).
• Requires manufacturers of PFAS since January 1, 2011, to report information:
• Chemical identity and molecular structure.
• Categories of use.
• Total amount manufactured or processed.
• Byproducts from manufacture or disposal.
• Health and environmental effects.
• Exposure numbers and duration.
• Disposal methods.
• Reporting must adhere to TSCA section 8(a)(5) guidelines.
• C. What action is the Agency taking?
• EPA is establishing reporting and recordkeeping requirements for PFAS manufacturers since January 1, 2011.
• Consideration given to comments from various stakeholders.
• Intent is to improve the understanding of PFAS in commerce and support PFAS exposure and contamination management.
• D. Why is the Agency taking this action?
• To fulfill TSCA section 8(a)(7) requirements.

III. Final PFAS Reporting and Recordkeeping Requirements

• A. What substances are covered by this rule?
• B. Which entities are covered by this rule?
•  
1. Scope of covered entities:

• Rule applies to anyone who has manufactured (including imported) a PFAS for a commercial purpose since January 1, 2011.
• NAICS codes in Unit I.A. may be included.
• Only manufacturers (including importers) are covered.
• Importers of PFAS in articles are considered manufacturers.

2. Scope of “manufacture for commercial purposes”:

• “Manufacture for commercial purposes” defined in line with TSCA section 8(f).
• Includes import, production, test marketing, self-use, and unintentional creation of PFAS.
• Exemptions include non-commercial R&D activities.

•  

3. Non-reportable activities:

• Entities that import or coincidentally produce PFAS are included.
• Waste management companies importing PFAS in municipal solid wastes are excluded due to lack of knowledge and analytical methods.
• However, waste management facilities involved in recycling or importing non-MSW PFAS wastes are included.

 

 

the previous submission (e.g., TSCA section, date of submission, and document control number or equivalent identifier). This ensures that EPA has a record of previously submitted information and can access it as necessary, without requiring duplicate submissions from reporters.

Summary in Bullet Points:

1. Consumer and Commercial Use:
• Indicator for consumer and/or commercial product.
• Product category.
• Functional use category(ies).
• Percent production volume for each use.
• Maximum concentration in any product.
• Indicator for use in products intended for children.
• Indicator for imported but never physically at site.
• Optional information from the article importer.
2. EPA Reporting Context:
• Streamlined reporting form for article importers.
• Applies reporting obligations to those with relevant information.
• Provides options for more detailed reporting if known to the importer.
3. Streamlined Reporting for R&D Substances Below 10kg:
• Scope includes any manufacturing for commercial advantage.
• Non-commercial purposes (pure research) are not included.
• Focuses on understanding PFAS manufactured in the U.S.
• Requires only limited information for small volume manufacturers.
• Required information includes: Chemical identity, chemical identification number, trade or common name, molecular structure, production volume, and optional data.
4. Information on Environmental and Health Effects:
• Requirement to submit all existing data on health and environmental impacts.
• Includes a broad scope of data (toxicity, ecological effects, exposure assessments, etc.).
• Defined as information in the submitter's possession or control.
• Not required to search public scientific literature.
• Avoidance of duplicate data submissions by referencing previous EPA submissions.

This summary breaks down the extensive information on the EPA's streamlined reporting system, focusing on the key elements and their implications.

The provided text is a comprehensive document detailing EPA regulations and guidelines on submitting environmental and health effects information concerning chemicals, specifically Per- and polyfluoroalkyl substances (PFAS). Below is a structured summary with bullet points:

Submission of Environmental and Health Effects Information:

1. Previous Submissions:
• If a reporter has previously submitted environmental and health effects information:
• They need to ensure all underlying information, including test data, was provided.
• If not all relevant information was submitted previously, they must still provide all existing information not previously submitted to the EPA.
2. Confidential Business Information (CBI):
• For information submitted to EPA as CBI before the 2016 Lautenberg Act amendments:
• Resubmission is required, with a reassertion of the CBI claim.
• If submitted post-Lautenberg Amendments:
• Manufacturers must provide details of the CBI claim, including when and under which authority it was submitted and the TSCA section 14 certification.
• To avoid resubmission and reassertion of a CBI claim, previous claims must adequately cover current claims.
• All CBI claims must be substantiated.
• EPA encourages careful review of previous submissions to ensure they meet current CBI substantiation requirements.
3. Data Format:
• Information should be submitted using OECD-harmonized templates.
• These templates can be accessed online and the IUCLID6 software can be used for exporting data in the correct format.
• Alongside the template, full study reports or underlying data as support documents should be submitted.
• If an OECD-harmonized template isn't available for certain data, manufacturers must still submit the relevant information.

Potentially Duplicative Reporting:

1. Avoiding Duplication:
• TSCA section 8 aims to avoid unnecessary or duplicative reporting.
• EPA aims not to collect duplicated data but wants to ensure all required data are collected and formatted correctly.
• Some data elements might overlap with the Chemical Data Reporting (CDR) Rule, but there are significant distinctions in the scope and specifics of reporting between CDR and this rule.

• Measures to Address Duplicative Reporting:
• EPA identifies information that's exempt from re-reporting if previously provided.
• Reporting exemption applies only to specific data elements from CDR, TRI, and GHGRP, studies under TSCA sections, and certain byproduct release information.
• Manufacturers must specify to which program and year the information was submitted previously.
• Previous submissions do not guarantee complete reporting for this rule. Manufacturers must ensure accurate, comprehensive data.

Previous Reporting on Environmental or Health Effects of PFAS:

• Reporters may have submitted information about PFAS effects under TSCA section 4 or EPA's National PFAS Testing Strategy.
• If a reporting entity has provided such details before, they:
• Don't need to resubmit for this rule.
• Should mention their prior submission to EPA with:
• Program details.
• Chemical identity.
• Submission date.
• Case number (if available).

Requirements for Submitting CBI Claims:

• 2016 amendments to TSCA introduced new requirements for CBI claims:
• Substantiation.
• Generic name.
• Certification.
• Agency review of certain CBI claims within 90 days.
• PFAS manufacturers may claim certain parts of the form as CBI:
• Specific chemical identities not on public Inventory.
• Company ID.
• Production volumes.
• Confidentiality claims must be made through the PFAS reporting tool.
• Reporters must certify the following:

1.                   They've taken measures to protect the confidentiality.

2.                   The information isn't mandated for public disclosure under Federal law.

3.                   Disclosure could cause substantial competitive harm.

4.                   Information isn't discoverable through reverse engineering.

5.                   All statements and information are true and correct.

Non-CBI Information:

• Certain data can't be claimed as CBI:
• Chemical identities on public Inventory or reported non-confidentially.
• All generic chemical names.
• CASRN for public PFAS.
• Inventory Accession Number for confidential PFAS.
• LVE numbers.
• Use information categories.
• Blank or NKRA responses.

Generic Name Requirement for CBI Claims:

• Entities claiming a chemical identity as CBI must provide a generic name as per TSCA section 14(c)(1)(C).
• Generic names must describe the chemical structure while protecting confidential features.
• For PFAS, the generic name must contain “fluor”.

Substantiation for CBI Claims:

• TSCA section 14 demands substantiation for each CBI claimed data element at the time of submission.
• Certain information is exempted from substantiation, such as production volume.

Limitations of CBI Protections:

• Health and safety study information is generally not protected.
• Certain information within health and safety studies can be protected.

Chemical Identity Reporting for Article Importers:

• Article importers may not know specific identifiers for confidential Inventory chemicals.
• They report known chemical identities.
• Public identifiers can't be claimed as CBI.

Chemical Identity Reporting for Other Entities:

• Must assert and substantiate CBI claims for chemical identities to ensure confidential treatment.
• Entities without knowledge of specific identifiers must start a joint submission with suppliers or other known entities.
• Reporting entities can't modify substantiations after the reporting period but can withdraw CBI claims.

Post-Reporting Period Actions by EPA:

• After reporting, EPA will list substances intended to move to the public Inventory.
• EPA will publish a list of Accession numbers on its website.
• Stakeholders can review the list and contact EPA with concerns.
• EPA will investigate any potential errors before updating the public Inventory.

 

H. Electronic Reporting Requirements

• General Requirements:
• EPA mandates all data be submitted electronically.
• This parallels 2013 requirements for other TSCA data (refer to 40 CFR 704.20(e)).
• Submission Portal:
• All data must be submitted through EPA’s Central Data Exchange (CDX).
• CDX is the main portal for electronic data reporting to EPA.
• Chemical Information Submission System (CISS):
• A web-based tool designed for TSCA submissions, housed within CDX.
• Facilitates user-friendly applications for constructing and submitting data packages securely.
• Can capture detailed data and allows attachments of various file types.
• CISS is found under “Submission for Chemical Safety and Pesticide Program (CSPP)” within CDX.
• Users familiar with TSCA submissions via CDX will recognize CSPP flow in their accounts.
• Rule-Specific Reporting Tool:
• EPA is designing a specific tool within CISS for these new requirements.
• Will be available before the reporting period starts (see Unit III.I on deadlines).
• Electronic reporting:
• Cuts down reporting burdens, cost, and time.
• Enables intra-organization sharing and easier record-keeping.
• Many potential reporters might already be accustomed to CDX electronic reporting.
• For newcomers to CDX, EPA offers guidance and a help desk.

I. Confidentiality in Reporting

• Joint Submissions:
• Joint submissions allowed for PFAS manufacturers who aren't privy to specific chemical identities because suppliers won't disclose.
• This system resembles the 2020 CDR cycle.
• How Joint Submission Works:
• Primary submitter sends most data they know.
• Sends request to a secondary entity (like a supplier) to provide PFAS identity.
• The secondary entity provides data directly to EPA, maintaining confidentiality.
• In situations where the direct supplier is unaware of PFAS identity, they can ask a tertiary supplier for the information.
• Confidentiality Details:
• Primary submitter can claim confidentiality over certain data without immediate substantiation.
• Secondary submitter must register with CDX and claim any necessary confidentiality.
• The secondary party is also responsible for substantiating their claims unless exempt.
• Confidentiality of all parties remains intact; no party can view the others' submissions.
• Caveats:
• Joint submissions should only be used when the reporter lacks knowledge of certain chemical details.
• If a reporter knows or can find out the chemical details, they must provide them regardless of others' CBI claims.
• Article importers are exempt from joint submissions.
• If no secondary submitter exists (e.g., a supplier has shut down), the primary reporter provides whatever details they can without initiating a joint submission.

 

J. When are reports due?

• EPA initially proposed:
• A six-month information collection period following the effective date of the final rule.
• A six-month reporting period.
• A reporting deadline one year after the effective rule's effective date.
• After receiving public comments (details in Unit IV.K):
• EPA decided on a one-year information collection period following the rule's effective date.
• This will be followed by a six-month reporting period.
• New Reporting Deadlines:
• Reporting forms will be due 18 months following the rule's effective date.
• Exception: For small article importers (defined at 40 CFR 704.3), forms are due 24 months after the rule's effective date.

K. What are the recordkeeping requirements?

• EPA is finalizing the previously proposed recordkeeping requirements.
• Reporting entities must retain records that document submitted information for five years.
• This retention starts on the last date of the information submission period.
• The five-year requirement matches the CDR rule and relates to the statute of limitations for violations.
• EPA views the burden of keeping these likely electronic records as minimal.

L. Which proposed requirements are not being finalized as proposed?

• Modifications to Proposed Rule:
• Definition of "PFAS" has been expanded.
• Reporting deadline has been adjusted.
• Some data elements requested have been changed.
• Streamlined reporting options have been introduced for certain article importers and manufacturers of R&D substances below 10 kilograms.
• Joint submissions are now enabled.
• Certain waste management/disposal facility exemptions have been specified.
• PFAS Definition:
• The new rule defines “PFAS” to include three specific chemical structures.
• This is an expansion from the original proposed definition.
• Reporting Deadline Modifications:
• EPA believes more time is needed for familiarization and data collection.
• Small manufacturers (as defined at 40 CFR 704.3) get an additional six months for reporting.
• Changes in Data Elements Requested:
• Based on public feedback, EPA removed certain proposed data elements from the final rule.
• Molecular structure reporting for Class 1 PFAS on the Inventory is now optional.
• The proposed data elements for worker exposure duration have been clarified.
• Other Changes:
• EPA is allowing two streamlined reporting options for some manufacturers.
• Joint submissions are now enabled in situations where an importer lacks knowledge of a chemical's specific identity.
• Importing municipal solid waste streams for disposal or destruction is not a reportable activity under this rule.

 

IV. Summary of Comments and Other Public Input and EPA’s Response

• Background:
• EPA received 109 unique public comments during the proposed rule's public comment period.
• Post-publication, more data related to the rule’s burden and cost estimates were collected.
• New data suggested that the proposed rule could significantly impact approximately 130,000 small businesses.
• Consequently, an SBAR Panel under the RFA was formed in April 2022 to evaluate the impact on small entities.
• This Panel led to the development of a Panel Report with recommendations for the final rule.
• Public Comments:
• Comments ranged from cost estimates of the 2021 Proposed Rule to the position of not exempting certain entities.
• After the Panel, EPA published a NODA and the SBAR Panel Report for further public comment.
• 44 unique comments were received post-NODA publication.
• Focus areas included regulatory alternatives and EPA's approach to CBI claims.
• A. Definition of Covered Substances:
• Public Input:
• Differing views on the definition of PFAS.
• Some wanted a narrowed definition, while others wanted it broadened.
• Critics of the EPA's definition pointed out inconsistencies with other agencies and claimed it was not scientifically sound.
• Suggestions were made to adopt the OECD definition of PFAS.
• Some states were cited as using broader definitions or class-based approaches.
• EPA’s Response:
• EPA acknowledged the variance in PFAS definitions but aimed to define it in line with TSCA section 8(a)(7).
• The final rule adopts a structural definition of PFAS, focusing on substances likely to be environmentally persistent.
• Reasons for not adopting the OECD definition include its breadth and the inclusion of substances not of primary concern to EPA.
• EPA's definition also considered environmental and human health impacts.
• The Agency focused on reporting that's necessary under TSCA section 8(a)(7), while minimizing unnecessary or duplicative reporting.

Inclusion of Trifluoroacetyl Fluoride (TFA) within the Rule's Scope

• Some commenters recommended including TFA within the rule's scope.
• EPA decided against this due to TFA's characteristics:
• TFA is a short-chain molecule (C2) with only one terminal -CF3.
• It differs from substances like PFOA, PFOS, and GenX.
• TFA naturally occurs or is produced as an environmental degradant.
• TFA is well-studied with available toxicity information.
• Reporting on TFA under TSCA section 8(a) is deemed unnecessary and duplicative.

Scope of Substances Reportable under the Rule

• The EPA disagrees with the idea that the rule should be a discrete list and not a structural definition.
• Some TSCA requirements rely on a structural definition.
• The scope for this rule is defined structurally to prevent limiting its reporting range.

Inclusion for Articles: Summary of Public Input

• Commenters supported the inclusion of articles in the proposed reporting:
• Necessary for understanding PFAS use and human exposure.
• Critical for state regulation.
• Knowledge of data gaps is beneficial.
• Congress authorizes the inclusion.
• TSCA’s definition of “chemical substance” is consistent with articles' inclusion.
• Commenters opposing the inclusion of articles reasoned:
• Inconsistent with past regulatory practices.
• Insufficient justification by EPA.
• Underestimation of the reporting burden.
• Difficulty in obtaining historical PFAS reporting information.
• Concerns about supply chains leading to duplicate information.
• Neutral comments were made on complexities associated with data collection on articles.

EPA's Response to the Comments on Articles' Inclusion

• EPA is finalizing the requirement to include PFAS-containing articles in the rule, based on what manufacturers can ascertain.
• EPA believes it has the authority to collect information on PFAS-containing articles.
• EPA has previously included articles in some other TSCA section 8 reporting rules.
• EPA disagrees with the idea that TSCA's definition of "chemical substance" excludes articles.
• Articles can be regulated under TSCA when they contain certain chemicals.
• TSCA section 8 regulations do not exclude articles from the definition of “chemical substances.”
• EPA has previously imposed requirements on chemical substances in articles.

Note: The document mentions it's a prepublication version signed by EPA on September 28, 2023. It's pending publication in the Federal Register and might not be the official version.

EPA's Response to Reporting on Articles and Undue Burden:

• EPA disagrees with the notion that reporting on articles is burdensome for the industry.
• The reporting standard only requires information known or reasonably ascertainable by the manufacturer.
• The reporting isn't about testing but about sharing existing knowledge or reasonably determined information.
• The lookback period is consistent with Congress's instructions.
• EPA believes reporting won't lead to duplication due to the complexities of the supply chain and manufacturing processes.
• There is no database currently available that has comprehensive data on PFAS in commerce, hence no basis to claim significant data gaps.
• EPA believes that each instance of PFAS importation should be reported.
• The scope of reporting shouldn't be limited to articles with the "greatest exposure potential."

Exclusion of Processors from Rule:

• Public Input Summary: A mix of comments in support of and against the inclusion of processors.
• EPA's Response:
• EPA clarifies that only manufacturers (including importers) are required to report, excluding processors.
• Future rulemaking might consider processors, but this particular rule is based on TSCA section 8(a)(7).
• EPA believes that including processors wouldn't lead to confusion or duplication, as other rules have included them.

Small Business Considerations:

• Public Input Summary: Mixed opinions on the inclusion of small businesses.
• Some felt small businesses should be exempt.
• Others believed all businesses, regardless of size, should report.
• Some comments focused on the definitions and requirements of TSCA.
• EPA's Response: Not directly provided in the provided text.

In summary, the EPA is emphasizing its perspective on the reporting requirements for PFAS, addressing concerns about burden, duplication, and the inclusion or exclusion of specific entities like processors or small businesses. The document reflects EPA's intention to gather comprehensive data on PFAS in commerce while aligning with the directives and guidelines of TSCA.

• EPA disagrees with the notion that reporting on articles is burdensome for the industry.
• The reporting standard only requires information known or reasonably ascertainable by the manufacturer.
• The reporting isn't about testing but about sharing existing knowledge or reasonably determined information.
• The lookback period is consistent with Congress's instructions.
• EPA believes reporting won't lead to duplication due to the complexities of the supply chain and manufacturing processes.
• There is no database currently available that has comprehensive data on PFAS in commerce, hence no basis to claim significant data gaps.
• EPA believes that each instance of PFAS importation should be reported.
• The scope of reporting shouldn't be limited to articles with the "greatest exposure potential."

Exclusion of Processors from Rule:

• Public Input Summary: A mix of comments in support of and against the inclusion of processors.
• EPA's Response:
• EPA clarifies that only manufacturers (including importers) are required to report, excluding processors.
• Future rulemaking might consider processors, but this particular rule is based on TSCA section 8(a)(7).
• EPA believes that including processors wouldn't lead to confusion or duplication, as other rules have included them.

Small Business Considerations:

• Public Input Summary: Mixed opinions on the inclusion of small businesses.
• Some felt small businesses should be exempt.
• Others believed all businesses, regardless of size, should report.
• Some comments focused on the definitions and requirements of TSCA.
• EPA's Response: Not directly provided in the provided text.

In summary, the EPA is emphasizing its perspective on the reporting requirements for PFAS, addressing concerns about burden, duplication, and the inclusion or exclusion of specific entities like processors or small businesses. The document reflects EPA's intention to gather comprehensive data on PFAS in commerce while aligning with the directives and guidelines of TSCA.

PA's Response to Concerns Regarding the Proposed Rule

• Response to Small Business/Manufacturer Exemption:
• EPA does not support a broad exemption for small businesses or manufacturers.
• Recognizes the resource limitations of small businesses.
• Modified the rule to offer some relief:
• Article importers and R&D substance manufacturers under 10kg/year can use a more streamlined reporting form.
• Extended the deadline to 18 months (24 months for small article importers).
• Rule's authority comes from TSCA section 8(a)(7) not 8(a)(1).
• Reporting from small manufacturers is deemed appropriate.
• Aims to require each person to report their PFAS manufacturing activities.
• Concern on Lack of TSCA Reporting Exemptions:
• Some commenters want exemptions/thresholds similar to other TSCA rules.
• Others prefer no exemptions to ensure comprehensive data.
• EPA's stance:
• Acknowledges the input.
• Decides against most exemptions found in other TSCA rules.
• Focuses on PFAS data, especially concerning human health and the environment.
• EPA aims to improve knowledge on PFAS and their uses.
• Application of the Reporting Standard:
• Public Input:
• Concerns over "reasonably ascertainable" definition.
• Divided feedback on proposed requirements.
• Requests for further clarification and guidance.
• EPA's stance:
• Values feedback and has made adjustments in rule and guidance.
• No reporting/recordkeeping requirement if no relevant information exists.
• "Due diligence" looks different for different entities.
• Not expected to survey all articles/products.
• Providing additional guidance on reporting standard, especially for article importers.
• Option for joint submission if supplier does not provide information.

G. Concerns Regarding Potential Duplicative Reporting

• Summary of Public Input:
• EPA received comments about potential duplicate reporting under the proposed rule.
• Most commenters believed the proposed requirements would result in unnecessary duplicate reporting, contrary to TSCA section 8(a)(5)(A).
• Many felt information required under the proposed rule is similar to information under the CDR rule.
• Some commenters mentioned studies under TSCA section 8(d) and TSCA section 8(e) as grounds for their stance.
• A minority opinion believed excluding prior CDR data would compromise EPA's data collection on PFAS.
• Concerns about duplicative reporting of articles and reimported articles were also raised.
• EPA's Response:
• EPA recognizes some data overlaps with 2020 CDR cycle but disagrees that the overlap is significant.
• Differences between CDR rule and this rule limit potential overlaps.
• CDR has exemptions not in this rule, so data reported to CDR and this rule may differ.
• PFAS reported to CDR are just a subset of PFAS for this rule.
• The years and methods of reporting data in CDR differ from this rule.
• EPA will not require re-submission of previously reported CDR data unless necessary.
• EPA agrees that TSCA section 8(e) submissions are relevant and has adjusted rules accordingly.
• EPA disagrees that reporting imported articles results in duplicative information.

H. Concerns Regarding the Lookback Period

• Summary of Public Input:
• Commenters believe a ten-year lookback is unfeasible and burdensome.
• Suggestions include shortening to 3 or 5 years to align with CDR.
• Concerns over supply chain complexities, supplier turnover, lack of historical requirements, and COVID-19 disruptions.
• Fear that data from the lookback period will be imprecise.
• Some suggested a “principal reporting year” approach like CDR.
• EPA’s Response:
• EPA disagrees with altering the lookback period.
• TSCA section 8(a)(7) clearly sets the lookback period from 2011.
• EPA acknowledges that available information may vary but insists manufacturers conduct due diligence and provide the necessary data.

Submission Period Duration and Reporting Deadline:

I. What is the submission period duration and reporting deadline?

1. Summary of public input:

• EPA received significant input regarding the proposed rule’s reporting deadline.
• Various alternatives were suggested ranging from 1.5 years to 5 years after rule promulgation.
• Commenters cited the need for time to familiarize with the rule, lack of systems for tracking data, confidentiality concerns, and external factors like COVID and supply chain disruptions.
• Some commenters urged EPA to maintain the proposed timeline due to the pressing need for PFAS data.

2. EPA’s response:

• EPA extended the initial proposal by adding six more months to the information collection period.
• The information collection period will now be one year from the rule's effective date followed by a six-month reporting submission period.
• Thus, the total time for all PFAS manufacturers will be 18 months after the rule's effective date, and small article importers get 24 months.

J. Can joint submissions be allowed?

1. Summary of public input:

• Some commenters wanted joint submissions, suggesting they might ease the reporting burden.
• Others felt joint submissions could still be burdensome.

2. EPA’s response:

• EPA finalized the requirement for joint submissions for reporters whose suppliers do not wish to disclose chemical identity.

K. What are the economic analysis considerations?

1. Summary of public input:

• Commenters felt that the proposed rule's impact on the industry was underestimated by EPA.
• Commenters provided specific feedback on burden estimates, costs, and discrepancies between this rule and the CDR.
• Some commenters felt EPA underestimated the burden on small businesses and article importers.
• Others believed the proposed rule underestimated the costs to the EPA itself.
• Commenters also discussed the social and health costs linked to PFAS exposure.

2. EPA’s response:

• EPA considered the feedback and convened an SBAR Panel in April 2022.
• The Agency increased estimates to account for the burden on article importers and small entities.
• EPA acknowledges the limitations of using CDR data but feels it provides a good industry average.
• EPA has updated its costs for handling the volume of reports to be submitted.
• Regarding social and health costs, EPA stated that the rule is a reporting and recordkeeping rule and thus does not have quantifiable benefits concerning those issues but acknowledges the qualitative benefits in the Economic Analysis.

CBI Claim Submission Requirements based on EPA Document from September 28, 2023

Summary of Public Input:

• General Feedback from Commenters:
• Some urge for simplified electronic reporting, joint submissions, simplified CBI substantiation procedures, and protection of CBI.
• Some ask for valid rationale for CBI exemptions, urging the EPA to disclose as much information as possible.
• Concerns about the rule's CBI protections being inadequate for R&D activities, especially in defense or national security.
• Requests for a “blanket substantiation” for all CBI claims.
• Others highlight the need for states to manage their PFAS issues and promote maximum information disclosure.
• PFAS Naming:
• Feedback on EPA’s proposal that any PFAS generic name should at least include “fluor”.
• Concerns about confusion if EPA implements this requirement.
• Mixed reactions on moving any unclaimed PFAS identity to the public TSCA Inventory without prior notice.

EPA’s Response:

• On Blanket CBI Claims Substantiation:
• EPA rejects the idea of blanket CBI claims substantiation.
• Each CBI claim must have specific substantiation, per TSCA section 14(c).
• Information Disclosure:
• EPA aims to disclose data not approved as CBI as much as possible.
• There are limits on confidentiality for health and safety studies. Submitters must provide a sanitized copy of the study if claiming parts as CBI.
• Working with States:
• States and tribes can request access to CBI in writing. EPA can grant access if they demonstrate they'll protect the information.
• On CBI Procedures & PFAS Naming:
• Article importers aren’t required to assert CBI for chemical identity.
• EPA will publish a list of Accession numbers associated with unclaimed or denied CBI claims.
• The “fluor” requirement in generic name submissions is finalized.

References:

• A list of documents referenced in the main document, from various sources including EPA, OECD, ATSDR, UNEP, academic journals, and more.

VI. Statutory and Executive Orders Reviews

• Source for more information: EPA's Laws and Executive Orders

A. Executive Orders 12866 and 14094: Regulatory Planning, Review, and Modernizing Regulatory Review

• Definition: This action is termed a “significant regulatory action” under section 3(f)(1) of Executive Order 12866.
• Submission: The action was submitted to OMB for Executive Order 12866 review.
• Documentation: Changes based on the Executive Order 12866 review can be found in the docket.
• Analysis: An economic analysis titled “Economic Analysis for the Final TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances” (Ref. 1) is available in the docket and summarized in Unit 1.E.

B. Paperwork Reduction Act (PRA)

• Definition: The rule's information collection requirements will be submitted for OMB approval under the PRA.
• Document Prepared: EPA's ICR document (EPA ICR No. 2682.02, OMB Control number 2070-0217).
• Enforceability: Requirements are not enforceable until approved by OMB.
• Purpose of Reporting: To meet obligations under TSCA section 8(a)(7) and gather data on PFAS since 2011.
• Use of Data: EPA aims to use this data for chemical assessments under TSCA and to inform environmental protection actions.
• Confidential Business Information (CBI): Information reported can be claimed as CBI with a supporting statement post-June 22, 2016.
• Reporting Details:
• Affected Entities: PFAS manufacturers.
• Obligation: Mandatory under TSCA section 8(a) and 40 CFR 705.
• Respondents: 131,410.
• Frequency: One-time.
• Burden: 3,878,744 hours/year.
• Cost: $281 million/year; $266.7 million/year at 3% and 7% discount rates respectively.

C. Regulatory Flexibility Act (RFA)

• Procedure: EPA created an IRFA for the proposed rule and convened an SBAR Panel for advice.
• Summaries: Available in the proposed rule’s NODA (Ref. 1).
• Final Analysis: A Final Regulatory Flexibility Analysis (FRFA) has been created, available in the docket (Ref. 29).
• Rule Objective: Comply with section 7351 of the FY2020 NDAA, mandating information on PFAS manufacturing since 2011.
• Development of the Final Rule: Based on public comments, findings from the SBAR Panel, and the IRFA.
• Comments on IRFA: 44 unique comments received. Comprehensive responses available in the docket (Ref. 21; Part 2).
• SBA Office of Advocacy Feedback:
• Comments Received: Comments on the proposed rule and the IRFA.
• Main Issues: Improper certification, need for an SBREFA Panel, underestimated compliance costs.
• EPA's Response: Convened an SBAR Panel, considered public input, identified regulatory alternatives.
• Result: Streamlined reporting, extended deadline, and additional guidance, with reduced costs for small entities. Detailed cost breakdown provided.

regulatory requirements that might significantly or uniquely affect small governments.

Summary in Bullet Points:

Estimate of the number of small entities to which the final rule applies:

• Industries impacted: utilities, construction, manufacturing, wholesale and retail trade, and some waste management.
• Exclusions: Entities only processing, distributing, and/or using PFAS without manufacturing or importing.
• Estimated affected firms: 97% of all firms (equivalent to 128,051 entities) would be considered “small business” by the SBA standard.
• All 128,051 firms will undertake rule familiarization and compliance determination.
• Estimated firms reporting under this rule: 13,021 small entities.

Reporting, recordkeeping, and other compliance requirements:

• Compliance requirements:
• EPA finalizing the reporting and recordkeeping rule for entities manufacturing PFAS since January 1, 2011.
• Required reporting: chemical identity, production volume, categories of use, byproducts, worker exposure, disposal practices, and environmental or health effects.
• Reporting deadline: 18 months post-effective date (24 months for some small manufacturers).
• Recordkeeping period: 5 years after reporting.
• Classes of small entities subject to compliance:
• PFAS manufacturers and importers since 2011, including those importing articles with PFAS.
• Professional skills needed:
• Expertise in chemistry for understanding structural definitions.
• Environmental and health data might require technical knowledge.
• Estimated costs for understanding the structural definition range from $831 to $1,212.

Steps taken to reduce economic impact on small entities:

• Small Business Advocacy Review Panel: EPA consulted with an SBAR Panel.
• Alternatives considered:
• Exemptions for small businesses or certain substances.
• Reporting thresholds based on production volume.
• Limiting PFAS scope to a predefined list.
• Streamlined reporting for low quantity R&D substances and imported articles.
• Longer compliance timeframe provided.
• EPA's decision was to collect maximum PFAS data while minimizing costs.

Small entity compliance guide:

• EPA has prepared a guide available in the rulemaking docket and on the EPA website.

Unfunded Mandates Reform Act (UMRA):

• The action may result in expenditures exceeding $100 million in one year.
• Authorizing legislation is TSCA section 8(a)(7) 15 U.S.C. 2607 (a)(7).
• Benefit-cost analysis:
• Total one-time private sector cost: Approximately $843 million (3% discount rate) or $800 million (7% discount rate).
• Benefits: Enhanced data for risk-screening and risk-management programs.
• Impacts on state, local, and tribal governments:
• No enforceable duties imposed on these governments.
• Governments are not typically engaged in activities impacted by this rule.

E. Executive Order 13132: Federalism

• Action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
• Will not have substantial direct effects on states.
• Will not affect the relationship between the national government and the states.
• Won't alter the distribution of power and responsibilities among various levels of government.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

• Action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).
• Will not have substantial direct effects on tribal governments.
• EPA does not anticipate PFAS was manufactured by Tribes for commercial purposes, hence no direct compliance costs on Tribal governments are expected.

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 certain regulatory actions.
• This action is not subject to Executive Order 13045 as it does not concern an environmental health or safety risk.
• EPA's Policy on Children’s Health does not apply.
• The regulatory action aims to fill data gaps related to PFAS manufacturing since 2011, which will inform future EPA actions.

H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution in Commerce, or Use

• Not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001).
• No anticipated adverse effect on the supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

• This rulemaking does not involve technical standards.

J. Executive Order 12898: Environmental Justice and Executive Order 14096: Commitment to Environmental Justice

• EPA believes an environmental justice analysis isn't feasible due to lack of data.
• Regulatory action will provide more data on PFAS exposures and risks.
• This information will aid communities, including those with environmental justice concerns.

K. Congressional Review Act (CRA)

• Action is subject to the CRA, 5 U.S.C. 801 et seq.
• This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR part 705

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

Dated: September 28, 2023.

• Michal Freedhoff, Assistant Administrator Office of Chemical Safety and Pollution Prevention.

 

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

• Sec. 705.1. Scope, compliance, and enforcement.
• (a) Details the reporting and recordkeeping procedures for manufacturers (including importers) of PFAS.
• (b) Describes the legal ramifications for failing to comply with the reporting and recordkeeping requirements.
• (c) Stipulates that persons who report under this part must maintain accurate records and allow EPA officials to access these records.
• Sec. 705.3. Definitions.
• Article: A manufactured item defined by its specific shape or design, its end-use functions, and its chemical composition.
• Central Data Exchange (CDX): EPA's centralized electronic submission system.
• Chemical Information Submission System (CISS): EPA's web-based reporting tool.
• Commercial use: Using a chemical substance in a commercial enterprise.
• Consumer use: Using a chemical substance made available to consumers.
• Environmental or health effects information: Data relating to the impact of a chemical substance on health or the environment.
• Health and safety studies: Studies about the effect of a chemical substance on health or the environment.
• Highest-level U.S. parent company: The top company in the site's ownership hierarchy within the United States.
• Industrial function: The intended characteristic for which a chemical substance is used.
• Industrial use: Use at a site where chemical substances are manufactured or processed.
• Sec. 705.5. Substances for which reports must be submitted.
• Sec. 705.10. Persons who must report.
• Sec. 705.12. Persons not subject to this part.
• Sec. 705.15. What information to report.
• Sec. 705.18. Article importer and R&D substance reporting options.
• Sec. 705.20. When to report.
• Sec. 705.22. Duplicative reporting.
• Sec. 705.25. Recordkeeping requirements.
• Sec. 705.30. Confidentiality claims.
• Sec. 705.35. Electronic reporting.
• Authority: Based on the provisions in 15 U.S.C. 2607(a)(7).

Definition and Clarity on Terms:

1. Intended for Use by Children: A chemical substance or mixture is intended for children aged 14 or younger if:
• The product is commonly recognized as being for children aged 14 or younger.
• The product labeling states it's intended for children aged 14 or younger.
• The product's marketing targets children aged 14 or younger.
2. Known to or Reasonably Ascertainable: Information in possession or control of a person, plus information that a similarly situated person is expected to possess or know.
3. Manufacture:
• Importing into the US customs territory.
• Producing or manufacturing for commercial purposes.
4. Manufacture for Commercial Purposes:
• Importing, producing, or manufacturing to gain a commercial advantage.
• Includes distribution for test marketing.
• Includes use for product research and development.
5. Per- and Polyfluoroalkyl Substances (PFAS): Chemical substances that contain specific structures.
6. Possession or Control: Pertains to the submitter and their affiliations.
7. Research and Development (R&D): Solely for scientific experimentation, research, or analysis.
8. Site-limited: Manufactured and processed within a site; not distributed outside.
9. Worker: Someone at a site who handles the chemical substance during work.

Regulatory Sections:

• § 705.5: Specifies which substances reports must be submitted for.
• § 705.10: Identifies who must report.
• § 705.12: Lists activities exempt from reporting.
• § 705.15: Details the information that must be reported.

Submission Details:

1. Company and Plant Site Information:
• Parent company details.
• Authorized Official details.
• Technical contact details.
• Site specifics including address and industry code.
2. Chemical-specific Information:
• Common name, identity, and molecular structure of each PFAS.
• Correct Chemical Abstracts name and CASRN for each PFAS.
• Specification on the type of number reported.

 

1. Codes for Chemical Identifying Number
• Table 1:
• Code A: TSCA Accession Number
• Code C: Chemical Abstracts Service Registry Number (CASRN)
• Code L: Low-volume exemption (LVE) Case Number
2. Identifying PFAS Details
• If PFAS' CASRN or specific identifier (i.e., Accession number or LVE number) is Not Known or Reasonably Ascertainable (NKRA):
• Submitter can provide a generic name or description.
• Joint submission can be initiated if the secondary submitter is known.
• Manufacturers should use the reporting tool under § 705.35.
• Manufacturers must provide detailed instructions to the supplier or other entity to submit chemical identity information.
• If no secondary submitter is known after due diligence, the reporter can indicate NKRA.
• PFAS manufacturers must provide as much detail as possible on PFAS identity.
3. Physical Form of PFAS
• Report the physical form(s) when:
• PFAS is sent off-site.
• PFAS is site-limited and reacted on-site.
• Forms include:
• (i) Dry powder
• (ii) Pellets or large crystals
• (iii) Water- or solvent-wet solid
• (iv) Other solid
• (v) Gas or vapor
• (vi) Liquid
4. Categories of Use
• For each PFAS since January 1, 2011:
• (1) Industrial processing and use information:
• Table 2:
• PC: Processing as a reactant
• PF: Processing—incorporation into formulation, mixture, or reaction product
• PA: Processing—incorporation into article
• PK: Processing—repackaging
• U: Use—non-incorporative activities
• (2) Corresponding Sector Code:
• Report the sector code corresponding to the industrial activities.
• For each chemical, report the code matching the sector(s) from Table 3.
• A particular sector code might be reported more than once depending on its function.

Table 3—Codes for Reporting Industrial Sectors

• IS1 Agriculture, forestry, fishing, and hunting.
• IS2 Oil and gas drilling, extraction, and support activities.
• IS3 Mining (except oil and gas) and support activities.
• IS4 Utilities.
• IS5 Construction.
• IS6 Food, beverage, and tobacco product manufacturing.
• IS7 Textiles, apparel, and leather manufacturing.
• IS8 Wood product manufacturing.
• IS9 Paper manufacturing.
• IS10 Printing and related support activities.
• IS11 Petroleum refineries.
• IS12 Asphalt paving, roofing, and coating materials manufacturing.
• IS13 Petroleum lubricating oil and grease manufacturing.
• IS14 All other petroleum and coal products manufacturing.
• IS15 Petrochemical manufacturing.
• IS16 Industrial gas manufacturing.
• IS17 Synthetic dye and pigment manufacturing.
• IS18 Carbon black manufacturing.
• IS19 All other basic inorganic chemical manufacturing.
• IS20 Cyclic crude and intermediate manufacturing.
• IS21 All other basic organic chemical manufacturing.
• IS22 Plastics material and resin manufacturing.
• IS23 Synthetic rubber manufacturing.
• IS24 Organic fiber manufacturing.
• IS25 Pesticide, fertilizer, and other agricultural chemical manufacturing.
• IS26 Pharmaceutical and medicine manufacturing.
• IS27 Paint and coating manufacturing.
• IS28 Adhesive manufacturing.
• IS29 Soap, cleaning compound, and toilet preparation manufacturing.
• IS30 Printing ink manufacturing.
• IS31 Explosives manufacturing.
• IS32 Custom compounding of purchased resins.
• IS33 Photographic film, paper, plate, and chemical manufacturing.
• IS34 All other chemical product and preparation manufacturing.
• IS35 Plastics product manufacturing.
• IS36 Rubber product manufacturing.
• IS37 Non-metallic mineral product manufacturing (includes cement, clay, concrete, glass, gypsum, lime, and other non-metallic mineral product manufacturing).
• IS38 Primary metal manufacturing.
• IS39 Fabricated metal product manufacturing.
• IS40 Machinery manufacturing.
• IS41 Computer and electronic product manufacturing.
• IS42 Electrical equipment, appliance, and component manufacturing.
• IS43 Transportation equipment manufacturing.
• IS44 Furniture and related product manufacturing.
• IS45 Miscellaneous manufacturing.
• IS46 Wholesale and retail trade.
• IS47 Services.
• IS48 Other (requires additional information).

Table 4—Codes for Reporting Function Categories

(Note: Only select codes are shown below due to length)

• F001 Abrasives
• F002 Etching agent
• F003 Adhesion/cohesion promoter
• ...
• F116 X-ray absorber
• F999 Other

Consumer and Commercial Use Information

• Submitters must use the codes in Table 5 to specify the product category(ies) where each PFAS is used.
• If more than 10 codes are relevant for a PFAS, only the 10 codes representing the largest percentage of the submitter's production volume should be reported.
• If none of the product categories in Table 5 accurately describe the products in which PFAS is used, the “Other” category can be selected, with an additional description of the use required.

 

Table 5—Codes for Reporting Consumer and Commercial Product Categories

Chemical: Substances in Furnishing, Cleaning, Treatment Care Products

• CC101: Construction and building materials covering large surface areas (stone, plaster, cement, glass, ceramics, textiles, apparel)
• CC102: Furniture & furnishings (soft plastics, leather)
• CC103: Furniture & furnishings (stone, plaster, cement, glass, ceramics, metal, rubber)
• CC104: Leather conditioner
• ... [followed by the rest of the codes from CC105 to CC132]

Chemical: Substances in Construction, Paint, Electrical, and Metal Products

• CC201: Fillers and putties
• ... [followed by the rest of the codes from CC202 to CC222]

Chemical: Substances in Packaging, Paper, Plastic, Toys, Hobby Products

• CC990: Non-TSCA use
• ... [followed by the rest of the codes from CC301 to CC317]

Chemical: Substances in Automotive, Fuel, Agriculture, Outdoor Use Products

• CC401: Exterior car washes and soaps
• ... [followed by the rest of the codes from CC402 to CC418]

Chemical: Substances in Products not Described by Other Codes

• CC980: Other (specify)
• CC990: Non-TSCA use

Key Points:

• Applicable Codes: For each product category, the applicable function category code from Table 4 must be selected to represent how the PFAS is used.
• Use Indication: Indicate if the product is for consumer or commercial use or both.
• Consumer Product Category for Children: Determine if any amount of each chemical substance is present in/on products intended for children age 14 or younger. Select from:
• Used in/on products for children
• Not used in/on products for children
• Information unknown or not ascertainable
• Concentration of PFAS: Estimate and report the typical maximum concentration of PFAS in products for each year of use.

Table 6—Codes for Reporting Maximum Concentration of Chemical Substance

• M1: Less than 1% by weight
• M2: 1% - 29% by weight
• M3: 30% - 59% by weight
• M4: 60% - 89% by weight
• M5: 90% and above by weight

PFAS Reporting Structure:

d) Manufactured amounts (since January 1, 2011):

• Total volume:
• Total annual volume (in pounds) of each PFAS domestically manufactured or imported at each site.
• Report total annual domestically manufactured volume and imported volume separately.
• Report to two significant figures of accuracy.
• Site designation:
• Indicate if the imported PFAS is physically present at the reporting site.
• Volume imported:
• Volume directly exported of each PFAS domestically manufactured or imported at each site.
• Production volume:
• Estimated percentage of total production volume associated with each combination from paragraph (c).
• Rounding rules for percentages.
• Site production volume:
• Estimated percentage of site's total production volume associated with paragraph (c)(4).
• Rounding rules for percentages.
• Site-limited:
• Indication if the PFAS was site-limited.
• Volume recycled:
• Total volume (in pounds) of each PFAS recycled on-site.

e) Byproduct reporting:

• Byproduct identification:
• Identify byproduct using CA Index name, CASRN, or TSCA Accession Number.
• Additional reporting codes and specifications.
• Releases:
• Indicate if the byproduct is released to the environment and specify the environmental medium.
• Volume:
• Annual byproduct volume released to the environment.

f) Environmental and health effects:

• OECD Harmonized Templates:
• Submit study reports and supporting information using IUCLID software.
• Human health data – preliminary studies:
• Provide additional human health data.
• Analytical tests:
• Provide names of analytical or test methods for PFAS.

g) Worker exposure data:

• Employment activities:
• Describe worker activities involving PFAS.
• Number of workers:
• Indicate the number of workers exposed per activity.
• Use codes from Table 7.
• Exposure scenarios:
• Maximum duration and frequency of exposure for workers.
• Exposure by category:
• Estimate number of exposed workers by combination from paragraph (c) using Table 7.
• Duration of exposure industrial use:
• Maximum duration and frequency of exposure for specific combinations.
• Commercial workers:
• Estimate number of exposed workers for commercial products using Table 7.
• Duration of exposure commercial use:
• Maximum duration and frequency of exposure for commercial workers.

h) Disposal data:

• Categories of disposal methods:
• Describe disposal processes or methods.
• Use appropriate codes from Table 8 and provide additional descriptions if needed.

Table 8—Codes for Reporting Disposal Methods

• Code | Disposal Method
• D1 | On-site land disposal: RCRA Class C landfill (hazardous)
• D2 | On-site land disposal: other landfill
• D3 | Other on-site land disposal
• D4 | On-site underground injection (UIC)
• D5 | Off-site land disposal: RCRA Class C landfill (hazardous)
• D6 | Off-site land disposal: other landfill
• D7 | On-site incineration
• D8 | Off-site incineration
• D9 | Publicly owned treatment works (POTW)
• D10 | Other off-site waste transfer
• D11 | Release to surface water
• D12 | Release to air (stack emissions)
• D13 | Release to air (fugitive emissions)
• D99 | Other

Additional Details and Reporting Requirements

• Disposal processes: Describe changes to disposal process(es) or method(s) as indicated in paragraph (h)(1) for any PFAS manufactured since 2011.
• Disposal volume: Report total volume of PFAS released to land, water, and air for each year since 2011.
• Incineration volume: Indicate the total volume of PFAS incinerated on-site each year since 2011, with details on incineration temperature.

§ 705.18 Article importer and R&D substance reporting options

• For one-time submission, streamlined reporting form available for certain manufacturers.
• Article reporting:
• Company and plant site information: All info as per § 705.15(a) must be reported.
• Chemical-specific information:
• Common/trade name, chemical identity, molecular structure.
• If identity unknown, provide a generic name/description.
• Categories of use:
• Industrial processing and use information: Report type of processing or use operation.
• Industrial activities sector: Report the sector of industrial activities.
• Sector specific function categories: Indicate function category of each reported sector.
• Consumer and commercial use information: Designate the product category for consumer/commercial use.
• Product specific function categories: Designate function category for each product.
• Consumer or commercial use designation: Specify if it's a consumer, commercial use, or both.
• In or on consumer products intended for children: Determine if PFAS is present in/on products for children aged 14 or younger.
• Estimated maximum concentration: For consumer/commercial products, report the estimated concentration of PFAS.

 

Table 9—Codes for Reporting Maximum Concentration of PFAS in an Imported Article

• Code — Concentration Range (% weight)
• AM1: Less than 0.1% by weight.
• AM2: At least 0.1% but less than 1% by weight.
• AM3: At least 1% but less than 10% by weight.
• AM4: At least 10% but less than 30% by weight.
• AM5: At least 30% by weight.

Notes:

• This table is from a prepublication document signed by EPA on September 28, 2023.
• It is pending publication in the Federal Register and is not the official version.

Imported Article Production Volume Reporting Requirements:

• Report production volume for each calendar year since January 1, 2011, if PFAS was imported in an article.
• Report to two significant figures of accuracy.
• Specify unit of measurement using Table 10.
• Designate if imported PFAS was ever physically present at the reporting site.

Table 10—Codes to Specify Unit of Measurement for the Imported Article Production Volume

• Code — Unit of Measurement
• LB: Pounds
• TN: Tons
• QT: Quantity of imported article
• O: Other (must specify)

Additional Article Data Reporting:

• Submitters can provide any extra information as requested under § 705.15 including supplemental attachments.

Research and Development (R&D) Reporting:

• Applicable for manufacturers of PFAS R&D substances with volumes ≤ 10 kilograms/year.
• Option to use a streamlined reporting form for each PFAS, for each year since January 1, 2011.

R&D Reporting Requirements:

1. Company and Plant Site Information:
• Report all details as per § 705.15(a).
2. Chemical-specific Information:
• Common/trade name, chemical identity, molecular structure (if not Class 1 on TSCA Inventory).
• Use TSCA Accession Number or LVE case number if needed.
• Specify type of number using codes from Table 1 of § 705.15(b)(1)(ii).
• For unknown or confidential PFAS, provide a generic name or description.
3. Production Volume Reporting:
• Report total annual volume (in pounds) since January 1, 2011, for each PFAS manufactured or imported.
• Specify domestically manufactured and imported volumes separately.
• Designate if imported PFAS was ever physically present at the reporting site.
4. Additional R&D Data:
• Submitters can provide any extra information as requested under § 705.15 including supplemental attachments.

§ 705.20 When to report.

• All information reported to EPA must be submitted during the applicable submission period.
• For reporters under § 705.15 and § 705.18(b) (research and development):
• Starts: [INSERT DATE 395 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]
• Ends: [INSERT DATE 548 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]
• For reporters exclusively under § 705.18(a) (article importers) and small manufacturers as defined by 40 CFR 704.3:
• Starts: [INSERT DATE 365 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]
• Ends: [INSERT DATE 730 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]

§ 705.22 Duplicative reporting.

• Covered persons can notify EPA of previous submissions.
• Must include:
• The statutory and regulatory provision of the previous submission.
• The year of the previous submission.
• If the prior submission did not cover all necessary information, it cannot be used to satisfy this rule's requirements.
• Chemical Data Reporting rule:
• No need for duplicative reporting if previously reported under 40 CFR Part 711.
• Duplicative areas:
1. Chemical description
2. Sector description
3. Product category
4. Workers
5. Volume
• Greenhouse Gas Reporting rule:
• No need for duplicative reporting if previously reported under 40 CFR part 98.
• Duplicative areas:
1. Imported
2. Exported
3. Incinerated
• Toxics Release Inventory reporting rule:
• No need for duplicative reporting if previously reported under 40 CFR part 372.
• Duplicative areas:
1. Recycled
2. Disposal
3. Release to land
4. Release to water
5. Release to air
6. Incinerated
• TSCA sections 8(d) and 8(e) reporting:
• No need for duplicative reporting of health and safety studies or substantial risk notifications.
• Duplicative area: Information concerning environmental and health effects of PFAS.
• Byproduct reporting:
• No need for duplicative reporting if byproducts are also PFAS reported independently.
• Duplicative areas:
1. Incineration
2. Byproduct volume
• Environmental and health effects information:
• No need for duplicative reporting unless required by § 705.30.
• Must include prior submission's EPA office and identifier.
• Reporting timeframe:
• Report all information since January 1, 2011, if manufactured a PFAS or a mixture containing PFAS.
• If not all years since 2011 were covered, submit information for the missing years.
• Exemptions or thresholds not applying to this rule means the information isn't considered duplicative.

§ 705.25 Recordkeeping requirements

• Individuals subject to the reporting requirements must retain records documenting the reported information to EPA.
• Records should be kept for 5 years, starting from the last day of the submission period.

§ 705.30 Confidentiality claims

(a) Making confidentiality claims

1. General Rule:
• Claims can be made for confidentiality at the time of information submission.
• Confidentiality claim instructions are in § 705.35.
• Confidential business information is treated as per 40 CFR part 703 and TSCA section 14.
2. Exceptions: Confidentiality cannot be claimed for:
• Chemical identity if public on TSCA Inventory or reported non-confidential in an LVE.
• Processing and use data elements in § 705.15(c)(1)-(7) and § 705.18(a)(3)(i)-(vii).
• Blank or “not known” responses.
• Specific chemical identity by article importer forms in § 705.18(a).
• All generic chemical names.
• Public PFAS on TSCA Inventory's CASRN.
• Inventory Accession Numbers for confidential PFAS on TSCA Inventory.
• LVE numbers.
3. Health and safety study information:
• Confidentiality can be claimed for certain information within a health and safety study.
• Those claiming confidentiality must provide a sanitized version for public release.
• Reassertion and re-substantiation of previous claims are required.

(b) Requirements:

• All confidentiality claims must be substantiated when submitted.
• Only authorized officials can sign and date claims.
• Some data elements, like Production volume and Joint submission information, are exempt from substantiation.

(c) Marking Confidential Information:

• Information in answers to questions listed in paragraph (e) that's claimed confidential must be clearly marked.

(d) Certification Statement:

• An authorized official must certify the submission, ensuring its compliance.

(e) Substantiation Requirements:

• Detailed written answers must be provided for each data element claimed as confidential, addressing:
• Harm due to release.
• Precautions taken.
• Disclosure under Federal law or publicly available information.
• Duration of claims.
• Previous disclosures.

(f) Additional Requirements for Specific Chemical Identity:

• Specific conditions and requirements are set for confidentiality claims related to specific chemical identity.

(g) Joint Submissions:

• Rules governing joint submissions, with primary and secondary submitters having specific responsibilities.

(h) No Claim of Confidentiality:

• Unclaimed information may be made public.
• EPA will provide notice of specific chemical identities added to the public TSCA Inventory.

 

§ 705.35 Electronic reporting

• Submission Platform: CDX
• All reporting forms required under this part must be completed and submitted using CDX.
• Submissions are restricted to the methods specified in this section.
• Information must be sent electronically to EPA through CDX.
• Language and Accuracy:
• All submitted information and attachments (unless the attachment is sourced from scientific literature) must be in English.
• All information submitted must be true and correct.
• Accessing the PFAS 8(a)(7) Reporting Tool:
• By Website:
• Navigate to the CDX homepage: https://cdx.epa.gov/
• Follow the links for the PFAS 8(a)(7) reporting tool.
• By Phone or E-mail:
• Contact the EPA TSCA Hotline at (202) 554-1404.
• Or email: TSCA-Hotline@epa.gov.
• Note: This information is from a prepublication version of a document signed by the EPA on September 28, 2023. It's pending publication in the Federal Register and, while EPA has worked to ensure accuracy, this isn't the official version

 

 

Reference: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-8a7-reporting-and-recordkeeping