Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a January 2022 enforcement alert entitled “Violations May Put Ski Wax Users at Risk from Illegal Perfluoroalkyl Substances.” According to the enforcement alert, EPA has identified several high-performance ski wax consumer products that contain perfluorinated chemicals that were not reviewed by EPA for health risks under the Toxic Substances Control Act (TSCA). EPA notes that these wax products are intended for use on sports equipment to enhance the performance of the equipment’s slick surfaces that are in contact with snow. The alert states that:

  • EPA is concerned that recently identified TSCA violations may be putting skiers and wax applicators at risk for exposure to certain persistent and bioaccumulative chemicals; and
     
  • EPA advises sellers of ski wax to ensure that the products they sell do not contain certain perfluorinated chemicals that are not on the TSCA Inventory or have prohibitions on their use in sporting goods.

The enforcement alert states that EPA identified several manufacturers, importers, and sellers that produced or sold ski wax products that included certain perfluorinated chemicals in violation of TSCA, which prohibits the manufacture, processing, or importation of a chemical that is not on the TSCA Inventory or otherwise exempt. TSCA requires anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to submit a premanufacture notice (PMN) at least 90 days prior to the manufacture, import, or processing of the chemical. According to the alert, review of the risks from per- and polyfluoroalkyl substances (PFAS) in ski waxes “is particularly important in light of the potential for ski wax technicians and recreational skiers who apply waxes to the skis to be exposed to PFAS from handling the waxes and from vapors released when the waxes are melted and applied to skis.” The alert notes that PFAS may enter the environment from the use of waxed skis and from the ski wax shavings scraped off during application.
 
The enforcement alert describes the following best practices for assessing whether a wax product contains a new chemical substance: (1) reviewing the product’s safety data sheet (SDS) and comparing the chemical substances against the TSCA Inventory; (2) contacting manufacturers and suppliers for additional chemical identity information where there is uncertainty regarding whether a chemical is on the TSCA Inventory; and (3) contacting EPA via the TSCA Hotline if it remains unclear whether a chemical substance is on the TSCA Inventory.
 
The enforcement alert provides information on EPA’s Audit Policy, under which regulated entities that voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. The alert states that most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system. According to the alert, many states also offer incentives for self-policing, and EPA suggests checking with the appropriate state agency for more information.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since January 1, 2011.
 
As reported in our June 11, 2021, memorandum, the fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts under the PFAS Strategic Roadmap. Comments on the proposed rule were due September 27, 2021.
 
EPA states that in response to public comments and additional information received during the comment period, it “is interested in convening an SBAR Panel.” The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. According to EPA, the Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, communities, or organizations to inform the Panel about the potential impacts of the proposed rule on small entities.
 
EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations must be received by February 16, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
Register Now

B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on December 28, 2021, it is granting a petition from six North Carolina public health and environmental justice organizations filed under Section 21 of the Toxic Substances Control Act (TSCA) to compel companies to conduct testing of certain per- and polyfluoroalkyl substances (PFAS). The previous Administration denied the petition on January 22, 2021. 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company to fund and carry out this testing under the direction of a panel of independent scientists. The petitioners requested that EPA reconsider its denial in March 2021, which EPA agreed to do in September 2021, in light of the change in Administration and attendant change in policy priorities concerning PFAS. As reported in our October 19, 2021, memorandum, EPA published a National PFAS Testing Strategy (Testing Strategy) that identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data. EPA states that these substances include many of the chemicals identified in the petition, as well as additional PFAS that will inform a wider universe of categories of PFAS where key data are lacking. For example, according to EPA, the first phase of testing on 24 PFAS is expected to provide data that can be extrapolated to 2,950 PFAS that belong to the same categories as the 24 individual substances.

EPA states that it has granted the petition and will use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the following studies that will provide toxicity data and information on categories of PFAS:

  • Near-Term Testing Covers 30 of 54 Petition Chemicals -- Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals;
  • Subsequent Testing May Cover Nine of 54 Petition Chemicals -- An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing;
  • Remaining 15 of 54 Petition Chemicals -- According to EPA, 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there are robust data on some of them available to it. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing;
  • Mixtures Studies -- EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS;
  • Human Studies -- EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to advance and expand on these efforts further. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina; and
  • Analytical Standards -- EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to issue in final next year.

Commentary

EPA’s reversal is hardly surprising. The Biden Administration’s commitment to obtaining information on PFAS is clear and has been reinforced in many contexts. In her remarks before the Committee on Energy and Commerce on October 27, 2021, for example, Assistant Administrator Freedhoff stated that EPA is “scouring all sources of information to identify important gaps in existing data and to select representative chemicals within identified categories or additional testing.” Reconsidering the prior Administration’s denial of the Section 21 petition seems like a no-brainer.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced the availability of its fiscal year (FY) 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

  • Audit of EPA’s Management of New Chemical Risk Assessments Conducted under the Toxic Substances Control Act (TSCA): Determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks;
     
  • Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
     
  • Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
     
  • Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
     
  • Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address Per- and Polyfluoroalkyl Substances (PFAS) in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
     
  • Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

Ongoing projects concerning Ensuring the Safe Use of Chemicals include:

  • Evaluation of EPA’s Cancer Assessment Review for Pesticide 1,3-Dichloropropene: Evaluate the extent to which EPA followed policies and procedures in developing the cancer assessment for the 1,3-dichloropropene pesticide registration review decision to prevent unreasonable adverse effects on human health; and
     
  • Evaluation of EPA’s Overdue Residual Risk and Technology Reviews: Evaluate whether EPA has conducted residual risk and technology reviews in a timely manner, as required for EPA to revise standards, as needed, to protect the public from air toxics emitted by stationary sources.

Planned and ongoing projects concerning Safeguarding Scientific Integrity Principles include:

  • Congressional Request: Evaluation of EPA’s Changes to Final Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Significant New Use Rule (SNUR): Determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances SNUR between the EPA Administrator’s signing of the final SNUR on June 22, 2020, and the publication of the final SNUR in the Federal Register on July 27, 2020; and
     
  • Evaluation of EPA’s January 2021 Perfluorobutane Sulfonic Acid (PFBS) Toxicity Assessment: Determine whether EPA’s Office of Research and Development (ORD) and Office of Chemical Safety and Pollution Prevention (OCSPP) followed applicable policies and procedures in the development and publication of the January 19, 2021, PFBS toxicity assessment.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 26, 2021, that it is acting upon a petition from New Mexico Governor Michelle Lujan Grisham (D) to address per- and polyfluorinated substances (PFAS) under the Resource Conservation and Recovery Act (RCRA). EPA states that in responding to the petition, it outlined plans to initiate the rulemaking process for two new RCRA actions, “reflecting the agency’s focus on using best available science and leveraging authorities to combat this shared challenge.” First, EPA will initiate the process to propose adding four PFAS as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS that EPA will evaluate are perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. EPA states that adding these chemicals as RCRA Hazardous Constituents “would ensure they are subject to corrective action requirements and would be a necessary building block for future work to regulate PFAS as a listed hazardous waste.” The second rulemaking effort will clarify in EPA’s regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA Section 1004(5). According to EPA, this modification would clarify that emerging contaminants such as PFAS can be cleaned up through the RCRA corrective action process.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released on October 18, 2021, the PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024. The Strategic Roadmap includes:

  • Timelines to set enforceable drinking water limits under the Safe Drinking Water Act (SDWA) to ensure water is safe to drink in every community;
  • A hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to strengthen the ability to hold polluters financially accountable;
  • Timelines for action -- whether it is data collection or rulemaking -- on Effluent Guideline Limitations under the Clean Water Act (CWA) for nine industrial categories;
  • A review of past actions on PFAS taken under the Toxic Substances Control Act (TSCA) to address those that are insufficiently protective;
  • Increased monitoring, data collection, and research so that EPA can identify what actions are needed and when to take them;
  • A final toxicity assessment for GenX that can be used to develop health advisories that will help communities make informed decisions the better to protect human health and ecological wellness; and
  • Continued efforts to build the technical foundation needed on PFAS air emissions to inform future actions under the Clean Air Act (CAA).

EPA also released a national PFAS testing strategy that will require PFAS manufacturers to provide toxicity data and information on categories of PFAS chemicals to inform future regulatory efforts. EPA states that it will select the PFAS to be tested “based on an approach that breaks the large number of PFAS into smaller categories based on similar features and considers what existing data are available for each category.” According to EPA, it will “strategically” select the initial set of test orders from more than 20 different categories of PFAS. EPA expects to use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund the studies. EPA plans to issue the first round of test orders by the end of 2021 with additional phases thereafter. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 2, 2021, the U.S. Environmental Protection Agency (EPA) received a petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. Filed by William David Bush, the petition states that the more than 4,000 chemicals in cigarette smoke come from chemicals within the soil, the paper surrounding the tobacco column, and the manufacturing process, while others are deliberately added. According to the petition, cigarette butts endanger the health of the environment, comprising 30-40 percent of items collected in annual coastal/urban cleanups. Organic compounds “seep from cigarette butts into aquatic ecosystems, becoming acutely toxic to fish and microorganisms.” The petitioner asks EPA to:

  • Determine that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment;
  • Order by rule that cigarette manufacturers eliminate the hazardous chemicals used in a mixture with tobacco, including but not limited to the toxic substance inclusions resulting from tobacco growing or handling techniques;
  • Order by rule that cigarette manufacturers develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment.

EPA acknowledged receipt of Bush’s petition on September 9, 2021, stating that it will grant or deny the petition by October 31, 2021.
 
EPA received a second TSCA Section 21 petition from Bush on August 16, 2021, seeking a determination that the chemical mixtures contained within cosmetics present an unreasonable risk of injury to public health and the environment. According to the petition, since 2009, almost 600 cosmetics manufacturers have reported using 88 chemicals in more than 73,000 products that have been linked to cancer, birth defects, or reproductive harm. The petition states that these toxic chemicals have been banned by the European Union (EU) “and many other nations.” The petition notes that Congress has not given the Food and Drug Administration (FDA) the authority to regulate the chronic risks posed by chemicals and contaminants in cosmetics and that FDA does not have the power to suspend registration or order recalls when products pose a risk of serious adverse health consequences or death. The petition asks that EPA order by rule that cosmetic manufacturers eliminate hazardous chemicals used in mixtures, stating that examples include formaldehyde, paraformaldehyde, methylene glycol, quaternium 15, mercury, dibutyl and diethylhexyl phthalates, isobutyl and isopropyl parabens, long-chain per- and polyfluoroalkyl substances (PFAS), and m- and o-phenylenediamine.

EPA acknowledged receipt of Bush’s second petition on September 20, 2021, stating that it will grant or deny the petition by November 14, 2021.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording, slides, and written Question and Answer (Q&A) document from our “PFAS Reporting Rules -- What Every Company Needs to Know” webinar, focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS), presented by B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D.
 
Do you wonder if the PFAS reporting rules extend to domestically-produced articles? Or if businesses that incorporate PFAS into their products are required to notify the end users? Do you know whether you need to report your Low Volume Exemption (LVE) substance? We encourage you to view the webinar and read the additional materials to learn answers to these and other questions related to EPA’s recent PFAS actions.
 
We also encourage you to consider the following issues discussed in the webinar and to submit comments to EPA regarding how these will affect your operations:

  • Identifying chemicals subject to reporting (i.e., specific PFAS and whether to include imported articles);
  • Considerations for economic analysis;
  • Submission period;
  • Potential duplicative reporting concerns;
  • Scope of “existing environmental and health information” collected;
  • Additional data elements or information collected;
  • EPA’s use and publication of non-confidential business information (CBI);
  • Availability of joint submissions; and
  • Small manufacturer considerations (i.e., regulatory and non-regulatory assistance and outreach).

Comments on EPA’s proposed PFAS rules are due on September 27, 2021.
 
The recording and slides are available online. E-mail .(JavaScript must be enabled to view this email address) to request written answers to selected questions from the Q&A session of the webinar.


 
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