On September 28, 2023, EPA finalized the rule for Recordkeeping and Reporting Requirements of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA).

This rule requires reporting of information on uses, production volume, disposal, exposure, and hazards of PFAS manufactured or imported since January 1, 2011. Reporting will be submitted electronically through EPA’s Central Data Exchange (CDX) portal, using the Chemical Information Submission System (CISS).

PFAS is defined in the final rule as a substance containing at least one of the following structures*:

  • R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons
  • R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons
  • CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons
*Fluoropolymers are included under this structural definition

 

Entities Subject to Reporting and Recordkeeping Requirements

Anyone who has manufactured and/or imported PFAS for a commercial purpose at any time from January 1, 2011 to September 28, 2023 is subject to the recordkeeping and one-time reporting requirements. This rule does not exempt imported articles (although a streamlined reporting option will be available to importers of articles). Small manufactures are also subject to the requirements of this rule.

Manufacturing (including importing) for a commercial use is defined by the Agency as “the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer”, including the manufacture of chemical substances or mixtures for:

  • commercial distribution, including test marketing
  • use by the manufacturer itself as an intermediate product for research and development (R&D)
  • coincidental byproducts and impurities produced during the manufacture, processing, use, or disposal of another chemical substance or mixture

The following activities are not required to be reported:

  • Non-commercial R&D activities (scientific experimentation, research, or analysis conducted by academic, government, or independent non-profit research organizations) providing there is no eventual commercial purpose
  • Waste management activities involving the import of municipal solid waste streams by waste management facilities for the purpose of disposal or destruction

 

What Information Must be Reported?

For each year since January 1, 2011, the following types of information are required to be reported:

  • Company and Site Information
  • Chemical-specific information for each PFAS for each year
    • Common or trade name
    • Chemical Abstracts Index name and corresponding CAS number, TSCA accession number, or Low Volume Exemption (LVE) case number (EPA is enabling joint submissions in cases where a supplier will not disclose the chemical identity to an importer)
    • Molecular structure (optional for Class 1 substances on the TSCA Inventory)
    • Physical form
  • Categories of Use, Release, and Disposal
    • Categories of use and corresponding sector code and function/product categories
    • Manufactured amounts for each category of use and Total Volume manufactured or imported
    • Site designation (whether imported PFAS is physically present at reporting site)
    • Import and Production Volumes
    • Indication whether the PFAS was site-limited, and volume recycled on-site
    • Byproduct reporting (activity that resulted in the manufacture of the PFAS byproduct; whether the byproduct is released to the environment, and if so, the medium to which it is released, and the volume released)
    • Disposal data (disposal methods, processes, and disposal volume & incineration volume)
  • Worker exposure data (employment activities, number of workers, exposure scenarios, exposure by category, duration of exposure for each use, exposure frequency)
  • All existing information concerning the environmental and health effects of each PFAS in the manufacturer’s possession or control (or other information for which they are responsible). This includes any information of any effect of a chemical substance or mixture on health, the environment, or both, such as:
    • Toxicity information (long- & short-term mutagenicity, carcinogenicity, teratogenicity; pharmacological effects; acute, sub-chronic, & chronic effects)
    • Ecological or other environmental effects on fish, invertebrates, or other animals and plants, such as bioconcentration or bioaccumulation tests
    • Human and environmental exposure assessments, including workplace exposure, & impacts on the environment
    • Monitoring data to measure the exposure of humans or the environment
    • Range-finding studies and preliminary studies
    • Adverse effects reports and any information including medical screening or surveillance

EPA states manufacturers/importers are not required to search open scientific literature not previously in their possession or control.

  • The names of any analytical methods or tests used to detect or test for the PFAS

 

Reporting Standard

Information known or reasonably ascertainable by the manufacturer is considered the reporting standard, which is identical to Chemical Data Reporting (CDR), under TSCA section 8(a)(2).  40 CFR 704.3 defines reasonably ascertainable as “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know”. This includes:

  • Reasonable inquiry/assessment within the full scope of the organization
  • Inquiries outside the organization
    • Phone calls or emails to upstream suppliers or downstream users, employees, or other people involved in the R&D, import or production, or marketing of the PFAS

EPA considers the following types of information to be in possession or control of the manufacturer:

  • Files maintained by the manufacturer such as marketing studies, sales reports, or customer surveys
  • Information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as Safety Data Sheet(s) or a supplier notification
  • Information from the CAS or from Dun & Bradstreet (DUNS)
  • Documented knowledge gained through discussions, conferences, and technical publications

 

What if a Manufacturer Cannot Reasonably Ascertain Actual Data?

Should actual data not be available to the manufacturer, they may rely on reasonable estimates, including mass balance calculations, emissions factors, and best engineering judgement.

If the information cannot be reasonably ascertained and an estimate cannot be reasonably made for a particular data element, the manufacturer may indicate “Not known or reasonably ascertainable” (NKRA).  EPA will not permit a NKRA designation to be claimed as confidential business information (CBI).

 

Duplicative Information

There are provisions in the rule to allow reporting entities to rely on certain previously submitted information under CDR, Toxics Release Inventory (TRI) reporting, Greenhouse Gas Reporting Program (GHGRP), and data submitted under certain TSCA rules or actions.  However, there are limitations as to whether the information is truly duplicative, given the differences between this rule and different reporting rules. The information previously reported must be accurate for the purposes of this rule.

If a reporting entity already submitted this information to EPA under other TSCA submissions, they may indicate the information and year in which it was submitted, rather than submitting duplicative information. However, the previous submission must include all required information. The reporting entity must resubmit the Information claimed as CBI if submitted prior to 2016, to reassert and substantiate CBI claims.

 

Streamlined Reporting Options

Streamlined reporting options will be available for the following substances:

  • PFAS contained in imported articles
  • R&D substances manufactured (including import) <10 Kg annually for a commercial purpose, if the manufacture/importer cannot reasonably ascertain the information required on the standard form

Reporting requirements will be set forth in 40 CFR 705.18.

 

When Must the Information be Reported to EPA?

EPA has finalized a 1-year period for collection of information from the date the final rule is effective (30 days after posting to the Federal Register), followed by a 6-month reporting period. Thus, manufacturers/importers will have a maximum of 18 months from the effective date of the final rule to report (the effective date is 30 days after the final rule is published in the Federal Register).

Reporting entities who are only subject to reporting for the import of articles and meet the standard of a small manufacturer will have an additional 6 months to report (maximum of 24 months from the effective date of the final rule). One of the following two standards must be met for a manufacturer/importer to be considered a small manufacturer:

  1. Total annual sales, when combined with those of its parent company, are less than $120 million, and the annual production volume of a chemical substance is less than 100,000 lbs
  1. Total annual sales, when combined with those of its parent company, are less than $12 million

 

Recordkeeping Requirements

Records documenting any information reported to EPA must be maintained for a period of 5 years by the entity subject to reporting. The 5-year period begins on the last date of the information submission period.

 

Differences Between the Proposed Rule and the Final Rule

The final rule includes the following modifications in comparison to the proposed rule:

  • Expanded definition of PFAS:
    • R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons
    • R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons
    • CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons
  • Removal of the following reporting data elements:
    • The maximum quantity on-site at any time including storage
    • the maximum first 12 months
    • production volume
    • the maximum yearly production volume in any 3 years
  • Modified request for the molecular structure of PFAS in all reports:
    • It will be optional for any Class 1 PFAS on the TSCA Inventory (required for other classes)
  • Modification of proposed data elements for worker exposure and duration:
    • Worker exposure duration information (both hours/day and days/year) is required for both the worker with the greatest daily exposure duration and for the worker with the greatest annual exposure frequency.
  • Streamlined reporting/modified scope of data elements required for imported articles and R&D substances manufactured below 10 Kg annually, when information is not known and may not be reasonably ascertained
  • Enabling of joint submissions when a supplier does not disclose the chemical identity to an importer
  • Modification of reportable activities:
    • importing municipal solid waste streams for the purpose of disposal or destruction is not a reportable activity under the rule

 

The SRC team is prepared to assist you with navigating this new rule and meeting the reporting requirements prior to the deadline. Contact our team of experts with any questions about compliance.

 

Jamie Venable

Senior Consultant

Published October 2, 2023