EPA Proposes Expansive and Retroactive Reporting Rule for PFAS

Proposed PFAS Reporting Rule

Amidst the rise of private party litigation, state regulatory activity, and global phase outs of per- and polyfluoroalkyl substances (PFAS), on June 28, 2021, EPA published a sweeping proposed rule under Section 8(a) of the Toxic Substances Control Act (TSCA) to collect detailed information from manufacturers and importers of PFAS chemicals, including products containing PFAS, in any year since 2011. The proposed rule is an expansive information collection effort under TSCA, and it will provide EPA with a robust data set of the PFAS manufactured and imported in the United States for the last ten years. Once obtained, this data on PFAS use, exposure, and effects could be used to assist EPA in developing assessments of new and existing chemicals under TSCA, as well to inform planned new regulatory activities under the Safe Drinking Water Act (SDWA), the Resource Conservation and Recovery Act (RCRA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

The one-time reporting requirement would be unprecedented in many respects, and it has the potential to impact many non-traditional TSCA stakeholders. The proposal is noteworthy for the number of PFAS chemicals it covers, the 10-year ‘look back” period for PFAS activities, and the lack of exclusions for PFAS present in trace amounts as an impurity, byproduct or in articles (i.e., finished products). The proposal would present substantial regulatory burdens on companies to better know the chemical identity of their products, including entities with complex and international supply chains, to ensure compliance.

EPA seeks comments by September 27, 2021, including on facets of the proposal that will be critical to determining the final rule’s applicability, including:  the scope of covered PFAS; the inclusion of articles, byproducts, and impurities; and the requirement to submit environmental and health effects information. EPA notes that comments on the proposed rule are best assured of consideration if the Office of Management and Budget receives a copy of the comments by July 28, 2021. Industry should carefully consider the potential regulatory burdens imposed by this proposed rule and seek to provide EPA with supporting detail to better inform the Agency’s decision making.

What is Section 8(a) of TSCA?

Section 8(a) of TSCA provides EPA broad authority to obtain information on chemicals in US commerce. EPA has used this authority to promulgate multiple reporting programs, including the Chemical Data Reporting (CDR) Rule, the Preliminary Assessment Information Rule (PAIR) and the withdrawn Comprehensive Assessment Information Rule (CAIR). Here, EPA is acting under the authority of Section 8(a)(7) of TSCA, which was added to the statute by the National Defense Authorization Act for Fiscal Year 2020 (NDAA). This provision requires EPA to promulgate a rule requiring each person who has manufactured a PFAS chemical in any year since January 1, 2011, to submit a report including information described in Section 8(a)(2).

Which PFAS chemicals would be subject to reporting?

The proposal extends far beyond the two most well studied PFAS chemicals, PFOA and PFOS, and takes a class-based approach to this family of chemicals, an approach EPA has rarely taken under TSCA except in limited situations, such as for polychlorinated biphenyls (PCBs), where the Agency was required to do so under Section 6(e) of the statute.

EPA has identified 1,346 PFAS chemicals on the TSCA Inventory as of April 2021 that could potentially be subject to reporting under the final rule, although only 669 of those were designated as active in commerce after June 2006 under the Inventory Reset Rule. EPA defines PFAS by using a chemical structure approach to capture PFAS not explicitly listed on the Inventory due to confidentiality protections. To help identify which PFAS would be covered, the proposal also contains five lists of PFAS chemicals (including CAS numbers), but states that these lists provide examples and are not comprehensive.  This approach creates ambiguity and uncertainty for regulated stakeholders.

The reporting requirements would apply to PFAS present as byproducts, impurities or in articles. And, notably, there is no de minimis or minimum volume of PFAS to trigger reporting, meaning reporting would be required for PFAS present only in trace amounts in an article.

Could my company be subject to reporting?

Under the proposal, reporting obligations apply to companies that manufactured or imported any of the covered PFAS since January 1, 2011. In addition, the preamble states:

For purposes of this proposed rule, articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings), are included in the scope of reportable chemical substances. TSCA does not define articles, nor does the statute define articles as a category of substances exclusive of chemical substances. EPA therefore considers its ability to regulate chemical substances to encompass authority to regulate articles containing such chemical substances.  

Based on these statements, EPA is clearly applying the proposal to imported PFAS-containing articles. What is less clear, and potentially concerning, is whether the proposal extends to “downstream” users of PFAS that domestically manufacturer articles containing PFAS, which would greatly increase the scope of already broad reporting requirements.

What information must be reported to EPA?

Companies would need to report details on chemical identity, uses, production volumes, descriptions of byproducts, environmental and health effects, worker exposure and disposal of PFAS. Based on the requirement to submit environmental and health effects information, the proposed rule goes beyond CDR requirements.

What reporting standard would apply to companies?

Manufacturers and importers of PFAS would need to report information required by the proposed ruled to the extent the information is “known to or reasonably ascertainable by” the party. EPA defines this standard to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” According to EPA, this standard would require submitters to conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees) in addition to inquiries outside of the organization to fill data gaps.

When would reports be due?

EPA includes a one-year reporting timeline following the final rule’s promulgation, which must occur by January 1, 2023 under Section 8(a)(7) of TSCA. Submissions would begin six months after the effective date of the final rule and last for a period of six months. In addition to reporting requirements, the proposal also includes a five-year recordkeeping obligation for submitters to preserve copies of any information reported to EPA.

Final Reporting Rule for 50 Common Chemicals

On the heels of announcing its proposed PFAS reporting rule, on June 29, 2021, EPA issued a final rule that will require manufacturers (including importers) to disclose certain unpublished health and safety data concerning 50 common chemicals to the Agency by September 27, 2021. 

The rule, issued under the authority of TSCA Section 8(d), requires any company manufacturing or importing the specified chemicals to provide EPA with copies of each unpublished health and safety study in their possession.  The chemicals covered by the new rule include:

• The 20 “high priority” chemicals currently undergoing TSCA risk evaluation:
  • Formaldehyde;
  • Five phthalates used as plasticizers in products like plastic pipes, toys, food packaging, cosmetics and medical/dental products (BBP, DBP, DEHP, DIBP and DCHP) and one chemical used to make phthalates (phthalic anhydride);
  • Three flame retardants (TBBPA, TCEP and TPP) and a chemical sometimes used in the manufacture of flame retardants and fire extinguishers (ethylene dibromide);
  • A fragrance additive found in perfumes, cosmetics and other consumer products (HHCB, also known as galaxolide);
  • Seven chlorinated solvents found in products like cleaning solutions, paint thinners and glues (1,1-dichloroethane, 1,2-dichloroethane, 1,2-dichloropropane, o-dichlorobenzene, p-dichlorobenzene, trans-1,2-dichloroethylene and 1,1,2-trichloroethane); and
  • A chemical used to manufacture synthetic rubber (1,3-butadiene)
• 30 organohalogen flame retardants, which the Consumer Product Safety Commission (CPSC) is currently evaluating for health and safety risks under the authority of the Federal Hazardous Substances Act (FHSA).

EPA will use the data in the health and safety studies collected under the new rule to inform its risk evaluations and identify chemicals for future prioritization.

The new rule, at a glance:

• Who must report? All persons or entities who, in the previous 10 years or presently, have either proposed to manufacture or have manufactured a listed chemical substance—even if that person or entity no longer does so.
• What must be reported about each identified chemical?
  • A list of the health and safety studies known to them, but not in their possession;
  • A list of the health and safety studies that are ongoing and are conducted by or for them;
  • A list of the health and safety studies that will be initiated and will be conducted by or for them;
  • A copy of each health and safety study in their possession; and
  • A copy of each health and safety study listed as ongoing or subsequently initiated, regardless of completion date.
• What counts as a “health and safety” study?
  • Studies on health effects, such as toxicity studies(in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetics (absorption, distribution, metabolism, or elimination), including modelling studies, in humans or animals’
  • Studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 CFR 716.50;
  • Studies on occupational (both users and non-users), general population, consumer, and environmental exposure, such as: studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modelling studies that estimate environmental concentrations or human exposures.
  • Studies showing any measurable content of the chemical in the tested substance (single substances or mixture), and the composition and purity of test substances must be reported if included as part of the study.
  • Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter’s own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies required under 40 CFR 716.35 and the submission of studies required under this rule.
• When must companies report?

Beginning July 29, 2021, and through September 27, 2021.

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