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.

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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.

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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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This week's All Things Chemical^® Podcast will be of interest to readers of the TSCAblog^®. A brief description of the episode written by Lynn L. Bergeson is below.
 
This week I sat down with Richard E. Engler, Ph..D., Director of Chemistry with Bergeson & Campbell, P.C. (B&C^®) and The Acta Group (Acta^®), to discuss the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals, especially those found in finished products, what EPA refers to as “articles.” The Toxic Substances Control Act (TSCA) has always applied to the products, or articles, that contain chemical substances of interest to EPA under TSCA. While EPA previously used that authority somewhat sparingly, the 2016 Amendments to TSCA have jump-started a new wave of regulations that expressly apply to articles. EPA is required under TSCA to regulate certain PBTs, and EPA issued a final rule earlier this year that inspired chaos in the business community, especially in the electronics sector and its complicated supply chain. Rich and I discuss these PBT rules and help explain what may well be the new normal with regard to the regulation of finished products under TSCA.

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WEBINAR
Thursday, September 9, 2021
11:00 a.m. – 12:00 p.m. (EDT)
Register Now

Bergeson & Campbell, P.C. (B&C^®) is pleased to present a complimentary webinar focused on the U.S. Environmental Protection Agency’s (EPA) proposed per- and polyfluoroalkyl substances (PFAS) regulations on September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT). B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., will discuss three actions recently taken by EPA:

• Proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States;
• Withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS; and
• Publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).

The proposed rule intended to obtain comprehensive data on PFAS 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.
 
As a result of these EPA regulatory actions, companies that never expected to need to know the Toxic Substances Control Act (TSCA) are now finding themselves in EPA’s crosshairs. This webinar will explore the full scope of these potential rules, how entities can determine if they will be subject to reporting, and the specific recordkeeping requirements that have been proposed.

Register for the webinar now
 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 29, 2021, the availability of the preliminary Toxics Release Inventory (TRI) data on chemical releases, chemical waste management, and pollution prevention activities that took place during 2020 at almost 21,000 federal and industrial facilities in the United States. EPA notes that the preliminary data include the first-ever reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA). The dataset is raw data and does not contain any summary or trend analysis. EPA plans to publish the updated TRI dataset in Fall 2021, and EPA will use it to develop the 2020 TRI National Analysis. EPA expects to publish the 2020 TRI National Analysis in early 2022. According to EPA, the public can use the preliminary data to identify facilities that report to TRI (for example, to locate facilities in a given ZIP code) and learn which chemicals facilities manage and in what quantities.

PFAS-Related Information from the 2020 Preliminary Data

EPA states that at this time, the data related to the PFAS added by the NDAA and received by EPA include 89 TRI reporting forms for 44 discrete PFAS filed by 38 individual facilities. The preliminary data indicate facilities managed more than 700,000 pounds of production-related waste of PFAS during 2020. As EPA reviews the data, it will examine the types of facilities that reported and that did not report, the specific PFAS that were reported and not reported, the information reported, by whom, and the communities in which PFAS are being released or otherwise managed as waste. According to EPA, it will seek to learn to what extent the current TRI reporting requirements regarding PFAS were followed and are adequate in providing the public with important information on the waste management practices of PFAS.

In analyzing the PFAS reporting, EPA states that it will also include a “focused and more rapid effort” intended to provide insights regarding the “seemingly limited” scope of the reporting, including the types and number of facilities reporting and PFAS reported. Depending upon its findings, EPA will take action “as appropriate,” including providing compliance assistance, taking enforcement actions, or proposing modifications to the TRI reporting requirements for PFAS.

The 2020 TRI National Analysis will include a section providing more detailed information on PFAS, including discussion on the quantities of PFAS that were released to the environment, recycled, burned for energy recovery or treated; source reduction activities implemented on PFAS; the facilities and sectors that disclosed this information; and the communities in which these activities took place.

EPA states that it will continue to add PFAS to the TRI per the requirements of the NDAA. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a significant new use rule under the Toxic Substances Control Act (TSCA). According to EPA, the TRI data collected will help inform its efforts under EPA Administrator Regan’s EPA Council on PFAS to understand better and ultimately reduce the potential risks caused by PFAS.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our June 28, 2021, blog item, on June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA announced on July 29, 2021, that it is extending the comment deadline to September 27, 2021. EPA will announce the extension of the comment deadline in the Federal Register.
 
The proposed rule would require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:

• Identifying the chemical substances that would be subject to reporting;
• Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
• Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
• Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
• Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
• Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
• EPA’s use and publication of certain non-confidential business information (CBI) data;
• Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
• Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.

More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 14, 2021, the U.S. Environmental Protection Agency (EPA) announced a stewardship program to encourage the voluntary withdrawal of previously granted low volume exemptions (LVE) for per- and polyfluoroalkyl substances (PFAS). According to EPA, the goal of the PFAS LVE Stewardship Program is to stop the ongoing manufacture of PFAS under previously approved LVEs that have not gone through the full pre-manufacture review process under the Toxic Substances Control Act (TSCA). EPA will hold a webinar on July 29, 2021, to provide an overview of the program.
 
EPA states that there are approximately 600 PFAS with currently granted LVEs. Through the program, EPA intends to work with trade associations, non-governmental organizations (NGO), and companies to encourage voluntary withdrawal of the LVEs. According to EPA, it based the new program on a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that were targeted for voluntary withdrawal at the time.
 
To participate in the program, companies with previously granted PFAS LVEs may choose to withdraw voluntarily their LVEs and certify that they will no longer manufacture or import those PFAS. Alternatively, companies may choose to withdraw voluntarily their LVEs following submission and review of a pre-manufacture notice (PMN), “which will provide for a robust safety review and the imposition of appropriate and enforceable protections for human health and the environment.” EPA states that it will provide recognition of program participants on its website.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA proposes to require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:

• Identifying the chemical substances that would be subject to reporting;
• Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
• Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
• Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
• Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
• Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
• EPA’s use and publication of certain non-confidential business information (CBI) data;
• Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
• Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.

Comments are due August 27, 2021. EPA states that “[‌u]nder the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.” More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA). Below is a brief summary of the actions. More detailed information and an insightful commentary are available in our forthcoming memorandum that will be posted on our website.

Proposed TSCA Rule to Require Reporting on PFAS Manufactured in the United States

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. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Withdrawing Compliance Guide on PFAS SNUR

In accordance with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review, EPA states that it has withdrawn a compliance guide that EPA believes weakened the July 27, 2020, final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances (85 Fed. Reg. 45109). The final rule prohibits companies from importing certain long-chain PFAS as part of a “surface coating” on articles without prior EPA review and approval. EPA states that examples of articles that could contain these PFAS as part of a surface coating include, but are not limited to, automotive parts, carpet, furniture, and electronic components.

As reported in our January 20, 2021, blog item, EPA issued the compliance guide in January 2021 in the last days of the previous Administration and limited what would be considered a “surface coating” subject to the SNUR. EPA states that “[t]he guide was never deemed necessary by career staff and its development was directed by political officials serving in the last Administration.” Additionally, EPA prepared the final guide without considering or addressing comments submitted by the public. After further review, EPA “determined that the guide inappropriately narrowed the scope and weakened the prohibitions included in the SNUR.”

Implementing NDAA Requirements to Report PFAS to TRI

The NDAA provided a framework for additional PFAS to be added to TRI on an annual basis. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a SNUR under TSCA. EPA issued a final rule on June 3, 2021, incorporating these requirements into the Code of Federal Regulations for TRI (86 Fed. Reg. 29698). Per the NDAA requirements, the PFAS additions became effective as of January 1, 2021. Reporting forms for these PFAS will be due to EPA by July 1, 2022, for calendar year 2021 data.

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