Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting

In July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:

  • EPA finalizes a toxicity value for a PFAS or class of PFAS;
  • EPA determines that a PFAS or a class of PFAS is covered by a TSCA Significant New Use Rule (SNUR);
  • EPA adds PFAS or a class of PFAS to an existing SNUR; or
  • EPA finds that a PFAS or class of PFAS is active in commerce (under TSCA Section 8).

Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.

EPA Issues First Test Order for PFAS in Commercial Firefighting Foam

EPA recently issued a test order under TSCA section 4 to select companies requiring that they develop and submit certain information on 6:2 fluorotelomer sulfonamide betaine, a PFAS. The order is part of the Agency’s National PFAS Testing Strategy which will evaluate a large number of PFAS for potential human and ecological effects as “most PFAS lack data for robustly characterizing their potential toxicity.

The test order was issued to Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc.  6:2 fluorotelomer sulfonamide betaine is used to make commercial firefighting foam and certain floor finishes.  The test order explains that EPA found insufficient data on 6:2 fluorotelomer sulfonamide betaine to determine or predict the effects on human health specifically by the inhalation route.  The order applies a tiered testing strategy.  EPA has ordered the companies to generate of data on certain physical-chemical properties (e.g., density, particle size, hydrolysis as a function of pH).  The Agency will use those data to determine whether further testing (e.g., inhalation toxicokinetic study, acute inhalation study) is needed.  Under TSCA section 4(a)(4), EPA is required to employ a tiered screening and testing process under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are necessary.

EPA intends to issue additional test orders to other PFAS manufacturers in the coming months. A detailed overview of the activities involved in issuing a TSCA Section 4 order can be found here.

PFAS From Certain Plastic Can Violate Chemicals Law, EPA Says

Earlier this year, EPA released a letter to manufacturers, processors, distributors, users, and those that dispose of fluorinated high-density polyethylene (HDPE), informing them of possible violations of the Toxic Substances Control Act (TSCA).  EPA determined through recent testing that certain PFAS have unintentionally formed during or following the process of fluorinating polyolefins. Manufacturers and processors of fluorinated polyolefins modify polymers with fluorine to create high-performance barriers.  These barriers are then used in the storage and transport of various products to keep the product inside the container without notable permeation.  During some methods of fluorination, such as in the presence of oxygen, PFAS can occur as a byproduct.

EPA first noticed the unintentional formation of PFAS in containers used in storing and transporting pesticides, and it is researching whether this problem occurs in other HDPE products. This effort to restrict human health and environmental exposure to PFAS is one of many steps the Agency has outlined in its PFAS Strategic Roadmap.

EPA’s letter reminds the HDPE industry that certain long-chain PFAS are subject to a TSCA Significant New Use Rule (SNUR) (See 40 CFR § 721.10536). Generally, chemical substances created during the manufacturing process that does not have a separate commercial purpose are considered byproducts and are exempt from SNUR requirements under 40 CFR § 721.45(e). But certain long-chain PFAS byproducts produced during the manufacture of fluorinated polyolefins do not meet the requirements of the byproducts exemption and therefore require a SNUR. These rules require the manufacturer to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemicals for significant new use.

The Agency encourages the industry to review the relevant regulations at 40 CFR § 721. Any questions on the topic can be directed to the Existing Chemicals Risk Management Division in the Office of Pollution Prevention and Toxics at

EPA Launches Stakeholder Outreach Effort to Help Speed New Chemical Reviews

On June 27, 2022, EPA announced its TSCA New Chemical Engineering Initiative.  EPA seeks to increase efficiency and transparency in the new chemical review process by inviting stakeholders to learn more about how the agency evaluates submitted information.  EPA plans to focus the initiative specifically on issues surrounding “engineering” information, including, but not limited to, occupational exposures and environmental releases.

The initiative has been launched in response to significant delays in new chemical reviews.  Frequently, submitters will provide additional information after the safety review process of a chemical under Section 5 of the Toxic Substances Control Act (TSCA) has already begun.  When EPA receives this additional information, it must revise its risk assessment (known as a “rework”) which causes delays in completing its review process and finalizing its risk assessment.  In an analysis of previous cases, EPA determined that an individual case may be reworked anywhere from one to five times, delaying the process at least several months.

EPA will be conducting a series of webinars providing an in-depth look at how the Agency analyzes submissions, including EPA’s written methodology of how its conducts analysis.  EPA intends to present case studies to stakeholders to further demonstrate what it considers acceptable in submissions.  Webinars will also communicate EPA’s considerations in evaluating qualitative claims or quantitative data, particularly in circumstances in which they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER).  Webinars will also discuss EPA’s considerations in evaluating information about sites that are not controlled by the submitter.

The kick-off meeting for the series was held on July 27, 2022.  The meeting detailed background on rework analysis, causes of reworks, examples of rework cases, and general observations.  EPA will be releasing information including the dates for two additional webinars in this fall.

EPA Releases Draft Revised Risk Determination for PV29

On March 7, 2022, EPA released a draft revision to the risk determination for C.I. Pigment Violet 29 (PV29).  Manufacturers and commercial clients use PV 29 as a weather fast and heat stable pigment in paints and coatings.  These paints and coatings are primarily used in automobiles and industrial carpeting.  The draft revision comes as part of the path forward EPA released in June 2021 for the first 10 risk evaluations under TSCA.

Risk evaluations are conducted under TSCA section 6.  TSCA requires the Agency to conduct risk evaluations to determine whether high priority substances present an unreasonable risk of injury to health or the environment.  EPA has determined that PV29, presents an unreasonable risk of injury to health.  This determination regarding PV29, evaluated the substance as a “whole chemical,” replaces previous determinations which were based on evaluations of individual conditions of use.

The draft revision risk determination for PV29 does not include an assumption of personal protective equipment (PPE) for workers. Instead, EPA stated that the Agency would consider the use of PPE, and any other potential mitigating factors, during its determination of risk management measures.  Note that the January 2021 risk evaluation for PV29found an unreasonable risk to workers, even when proper use of PPE is assumed.  The January 2021 risk evaluation identified 14 categories of use and found unreasonable risk exists in 10 of those categories including:

  • manufacture,
  • processing,
  • paints/coatings and merchant ink for commercial printing categories of Industrial/commercial use, and
  • disposal.

The draft revision states these same conditions of use will continue to drive EPA’s determination of unreasonable risk for PV 29.  The categories of use that were not found to present an unreasonable risk are: distribution in commerce, industrial/commercial use in plastic and rubber products, and consumer uses.

PIP (3:1) Compliance Date Extended to October 31, 2024

On January 6, 2021, EPA issued a rule limiting manufacturing, importing, processing, and distribution of products containing phenol, isopropylated phosphate (3:1) (PIP (3:1)).  That rule was scheduled to take effect on February 5, 2021, with a March 8, 2021, compliance date.  After this date, companies would be prohibited from processing and distributing PIP (3:1) and PIP (3:1)-containing products unless there was an applicable exclusion.  Furthermore, after the compliance date, the rule prohibited the release of PIP (3:1) into water during manufacturing, processing, and distribution.  This final rule also required commercial users to follow existing regulations and best practices to prevent the release of PIP (3:1) and products containing PIP (3:1) into water.  On March 8, 2022, the effective compliance date of the rule was extended to October 3, 2024.

The March 2022 extension applies to the following consumer and commercial goods: cellular telephones, laptop computers, electronic devices, and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.  Notably, this is not an exhaustive list of the goods affected by the rule.  This extension follows the publication of the initial rule in January 2021, no action assurance issued in March 2021, and the September 2021 extension which expired on March 8, 2022.  These milestones are discussed in greater detail below.

In January 2021, EPA released risk management rules under the Toxic Substances Control Act (TSCA) intended to mitigate exposure to five chemicals that are persistent, bioaccumulative and toxic (PBT).  The five chemicals listed under this rule are decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris (tert-butyl) phenol (2, 4, 6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The rules were designed to either limit or prohibit manufacturing, importing, processing, and distributing the aforementioned chemicals.  Following the publication of these rules, EPA received numerous comments from manufacturers and processors of PIP (3:1) asserting that the March 8, 2021, compliance date did not provide stakeholders with enough time to find viable chemical substitutes.  Consequently, on March 8, 2021, EPA provided a no action assurance letter on enforcement of the rule.  The no action assurance expired on September 4, 2021.  Subsequently, on September 17, 2021, EPA issued a short-term extension of specific compliance deadlines for the processing and distribution of PIP (3:1) and articles containing PIP (3:1) to March 8, 2022. On March 8, 2022, a further extension was granted, which moved the compliance deadline to October 31, 2024.

OIG to Audit EPA New Chemicals Review

EPA’s Office of Inspector General (OIG) has informed the Office of Chemical Safety and Pollution Prevention (OCSPP) that it will audit EPA’s process for conducting reviews of new TSCA chemicals (i.e., substances submitted to the Premanufacture Notification (PMN) and PMN exemption processes).  This is a self-initiated audit to accomplish OIG’s oversight plan for fiscal year 2022, to address ensuring safe use of chemicals, and to address complaints from the OIG Hotline.  OIG seeks to determine the extent EPA is following records-management requirements, quality-assurance requirements, and employee performance standards.  OIG will also be looking at how EPA manages human health and environmental risks for approving new chemicals under TSCA.

OIG has asked OCSPP to assist in expediting the audit by providing all materials, handbooks, and anything related to the review of new chemicals; the resource allocations for chemical review from fiscal years 2018 through 2021; scopes of work for any contracts related to chemical review; any guidance they have received on chemical review; and new chemicals review program organization charts before and after the October 2020 reorganization.

OIG notes authority under the Inspector General Act of 1078, as amended, to have timely access to their requests and personnel.  In addition to the Inspector General Act, in its request, OIG references EPA Manual 6500 and statements from Administrator Michael S. Regan.

EPA Announces Improvements to the TSCA Risk Evaluation Process  

On December 20, 2021, EPA released a draft TSCA Systematic Review Protocol. In its announcement on the new Protocol, the Agency explained that the Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA Risk Evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment.  The draft protocol comprises nearly 700 pages.

The draft Protocol notes that EPA’s Office of Pollution Prevention and Toxics (OPPT) applies systematic review principles in the development of its Risk Evaluations of existing chemicals.  It provides specific systematic review approaches which they use for identifying and evaluating evidence for the hazard and exposure assessments that support Risk Evaluations. OPPT added that the draft Protocol responds to key recommendations received from the National Academies of Sciences, Engineering, and Medicine (NASEM).

The Protocol was developed in response to NASEM’s critique that EPA had not previously documented how TSCA prioritization and problem formulation relate to the TSCA Systematic Review.  The Protocol aligns the TSCA prioritization and scoping processes with the steps of the Protocol.  In addition, the Protocol defines how EPA’s systematic review efforts will identify data gaps and data needs in the Risk Evaluations process.  OPPT explains that identifying these data gaps and data needs will provide the Agency with the information it needs “to strategically exercise TSCA authorities to require testing or information collection for use in TSCA prioritization and Risk Evaluation.”

The Protocol reports that for the 20 high-priority substances currently undergoing Risk Evaluation and substances undergoing manufacturer-requested Risk Evaluation, EPA has implemented a new, unified literature search process.  This process, as described in the Protocol, uses chemical identifiers to maximize the capture of relevant literature, which in turn provides consistency and efficiency to the literature search.  In addition, OPPT announced that the Protocol includes new methods to reduce bias and improve evaluation through the use of calibration exercises and data evaluation training for reviewers.  This is a response to NASEM recommendations, SACC comments, and public comments.

In addition, the Protocol includes a description of the evidence integration process.  A step that was not part of the 2018 TSCA systemic review document. This addition was also made in response to recommendations by the NASEM and the SACC. OPPT explains that the Protocol’s evidence integration approach relies on methods related to those in EPA’s IRIS Handbook.

The draft protocol will undergo peer review by at a meeting of the SACC on April 19-21, 2022.  OPPT noted that the agency will use this feedback to further improve the document. The date, time for the public peer review virtual meeting will be announced on the SACC website.

Ending Inventory Correction for Substances Listed to the Initial TSCA Inventory

On February 24, 2022, EPA announced that is revoking the process for correcting the substance identities of substances that were incorrectly described when they were listed on the initial TSCA Inventory in 1978.  Guidelines for Inventory correction were published in 1980 when the Agency recognized that a number of the substances reported to the initial Inventory had been unintentionally, incorrectly described.  Starting on April 26, 2022, companies will be required to submit a premanufacture notice (PMN) in order to request a change to the chemical identity of a substance listed on the Inventory.  Until that time, EPA will continue to accept correction requests that meet the 1980 guidelines.

In its announcement, EPA noted that the 1980 guidelines did not identify a time period during which corrections to the Inventory could be submitted.  However, EPA stated they never intended for the correction period to be indefinite, noting that companies have had more than 40 years since the 1980 publication of the revised TSCA Inventory to make corrections.

EPA stated they will continue to initiate Inventory corrections for substances that it determines were unintentionally misidentified.  For those cases, EPA may request information from a company to support an Inventory correction in lieu of requiring a PMN.  The announcement noted that the revocation will not affect regular maintenance of the Inventory which does include updates to substance identity nomenclature.

EPA Extends Submission Deadline for Health and Safety Studies on 50 Chemicals

EPA is allowing manufacturers and importers additional time to submit unpublished health and safety studies’ data for 50 chemicals.  The new deadline for 20 of the 50 chemicals is December 1, 2021, updated from September 27, 2021.  The new deadline for the remaining 30 chemicals is January 25, 2022.  The 20 chemicals in the first group fall into the category of high priority for risk evaluation – note that EPA explains that being classified as high priority does not necessarily mean that a chemical is high risk.  These chemicals are currently undergoing Risk Evaluation under TSCA.  The Health and Safety studies will help EPA prepare scoping documents that identify the hazards, exposures, conditions of use of the chemicals, and potential exposures to them.

The 30 chemicals in the second group are organohalogen flame retardants.  These chemicals are being evaluated by the Consumer Product Safety Commission, which is a member of TSCA’s Interagency Testing Committee.

Additional information on the reporting requirements for the 50 chemicals can be found here and additional information on initial addition of the chemicals to the list here.