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
 
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

The U.S. Environmental Protection Agency (EPA) announced on October 15, 2021, that it is updating the confidential status of 377 chemical identities and will include these chemical identities on the next update of the Toxic Substances Control Act (TSCA) Inventory, planned for winter 2022. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, the Inventory contains 86,607 chemicals, of which 41,953 are active in U.S commerce.

As reported in our April 30, 2021, blog item, in April 2021, EPA announced its review of 390 specific chemical identities that were expected to lose their confidential status on the TSCA Inventory. Of the 390 chemicals under review, EPA states that it found that 13 accession numbers corresponded to substances that are already on the public portion of the Inventory or to substances reported using an invalid accession number (which was later corrected and/or the confidentiality claim was withdrawn). The remaining 377 chemical identities were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) periods -- “meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce. Therefore, these substances are no longer eligible for continued confidential Inventory status.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:

  • New OCSPP Science Policy Council and New Science Policy Advisor Position: OCSPP is forming a new internal advisory group, the OCSPP Science Policy Council, to provide advisory support and recommendations on science policy and scientific integrity issues that arise within its Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP). The OCSPP Science Policy Council will be chaired by a science policy advisor, a newly created position. The science policy advisor will report to the OCSPP Assistant Administrator, provide guidance on emerging science policy and scientific integrity matters, and serve as the deputy scientific integrity official for OCSPP. OCSPP states that the OCSPP Science Policy Council will provide an advisory perspective on matters related to scientific integrity; identify scientific questions that are of broad interest within OCSPP for informal review and, as appropriate, recommend a process for further addressing them; and foster informal opportunities for scientific collaboration within OCSPP. Members chosen to address specific issues or questions will be selected based on their expertise and impartiality on the issue or question, and they may include EPA experts outside of OCSPP. OCSPP notes that the group is not intended to replace or otherwise interfere with EPA’s Scientific Integrity Policy, the Scientific Integrity Official’s role, or the Inspector General’s role.
  • Strengthening New Chemical Safety Reviews: According to OCSPP, as part of its broader review of policies and procedures to ensure the program effectively implements the Biden Administration’s executive orders, other directives, and principles of scientific integrity, OCSPP’s New Chemicals Division (NCD) engaged in a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOP), decision making, and recordkeeping practices related to review and management of new chemicals under the Toxic Substances Control Act (TSCA). OCSPP states that to date, NCD has inventoried and reviewed over 100 different SOPs, guidances, and science policies, and prioritized those that NCD expects to be updated over the next year. Several policy changes have already been implemented, including stopping harmful new per- and polyfluoroalkyl substances (PFAS) from entering the market and procedures to strengthen the review of new chemicals and ensure worker safety.
    • New Chemicals Advisory Committee: According to OCSPP, NCD has formed the New Chemicals Advisory Committee (NCAC) that, similar to other long-standing internal advisory bodies within OCSPP, will serve as an advisory body to review both scientific and science policy issues related to new chemical submissions subject to TSCA. If differing opinions cannot be resolved through the human health risk assessment process improvements described below, the NCAC and OCSPP Science Policy Council could provide additional opportunities for further consideration.
    • Human Health Risk Assessment Process Improvements: According to OCSPP, NCD solicited feedback from staff and implemented important changes to its process for reviewing and issuing final human health risk assessments. The new process provides additional opportunities for resolution of differing scientific opinions and invites input to the decision-making process to be provided by EPA subject matter experts outside of NCD.
    • Enhanced Recordkeeping Requirements: Proper documentation of decisions and of any differing scientific opinions of those decisions is a significant component of EPA’s Scientific Integrity Policy. OCSPP states that it has implemented some changes to its procedures to ensure improved documentation of decisions and is in the process of further review to identify additional improvements, if any, including for new chemicals human health risk assessments.
  • Workplace Climate Assessment: In September 2021, with the support of an independent contractor, OCSPP launched a workplace climate assessment of the NCD to obtain feedback from employees and management about any potential workplace barriers and opportunities for organizational improvement. OCSPP states that this effort will expand to other parts of OCSPP over the coming months. OCSPP leadership will use the feedback collected to understand, evaluate, and, if necessary, make changes in its work practices and culture to promote collaboration and enhance the science used in its program decision making.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 7, 2021, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) completed its review of a proposed rule on “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension.” The U.S. Environmental Protection Agency (EPA) announced on September 3, 2021, an extension of certain compliance dates for Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)) to March 8, 2022, “to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule to ensure that supply chains are not disrupted for key consumer and commercial goods.” The proposed rule reviewed by OIRA is expected to propose further extensions to certain article-related compliance dates. More information on EPA’s September 3, 2021, announcement is available in our memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) posted a WatchBlog item entitled “Can Chemical Recycling Reduce Plastic Pollution?” on October 5, 2021. The item looks at GAO’s September 2021 Science & Tech Spotlight: Advanced Plastic Recycling. According to GAO, chemical recycling could reduce the amount of plastic that ends up in landfills, potentially reducing the release of chemicals into the environment. Chemical recycling can produce high-quality raw materials, decreasing the demand for fossil fuels and other natural resources. GAO states that the obstacles to using chemical recycling include process and technology challenges, high startup and operating costs, and limited incentives for recycling innovation and investment. GAO notes that new plastics produced from fossil fuels are typically cheaper to produce than recycled plastics, in part due to transportation costs and limited recycling infrastructure, making recycled plastics less marketable. Key questions for policymakers include:

  • What steps could the federal government, states, and other stakeholders take to further incentivize chemical recycling rather than disposal? What are the potential benefits and challenges of these approaches?
     
  • What steps could policymakers take to support a transition toward a circular economy -- one in which products are not disposed of but are recycled for reuse including innovation -- and investment in manufacturing and recycling capacity?
     
  • What might policymakers do to promote advanced recycling technologies while also reducing the hazards associated with existing plastic production and recycling methods?

One issue that GAO fails to consider is the regulatory status of depolymerized plastic. If a polymer cannot be reduced back to the exact starting monomers, the U.S. Environmental Protection Agency (EPA) views the depolymerized plastic as a substance that is different from the starting monomers. Furthermore, making a polymer with depolymerized plastic is, according to the Toxic Substances Control Act (TSCA) nomenclature rules, different than the virgin polymer. These nomenclature complications will likely be a barrier to the commercialization of the closed-loop chemical recycling of plastics.


 

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a proposed rule on September 28, 2021, that would codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI). 86 Fed. Reg. 53577. Although the existing regulation requires a facility reporting to TRI to identify its parent company in annual reporting forms, no codified definition of this data element exists. EPA states that a codified definition of parent company would allow it to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. The proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving data quality. The proposed rule addresses the following ownership scenarios:

  • A facility is owned by a single company that is not owned by another company;
  • A facility is owned by a single company that is owned by another company;
  • A facility is owned by multiple companies, including companies that are themselves owned by other entities;
  • A facility is owned by a joint venture or cooperative;
  • A facility is owned, at least in part, by a foreign company; and
  • A facility is owned by the federal government, or a state, tribal, or municipal government.

EPA also proposes to require facilities reporting to TRI to use standardized naming conventions for parent company reporting, as provided in the annual TRI Reporting Forms and Instructions (RFI), available as a downloadable Excel file (“Standardized Parent Company Names”) at http://www.epa.gov/tri/rfi. EPA states that these naming conventions address common formatting discrepancies, such as punctuation, capitalization, and abbreviations (for example, “Corp” for “Corporation”). Comments are due November 29, 2021. According to the notice, under 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 comments by October 28, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals include:

  • Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under the Toxic Substances Control Act (TSCA). The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
     
  • Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.

EPA will publish a notice in the Federal Register extending the deadline. A pre-publication version of the notice is available on EPA’s website. EPA has also posted a “historic” question and answer document about reporting under TSCA Section 8(d). Detailed information about the reporting rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”


 

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 24, 2021, for stakeholders to learn how to access and use the pollution prevention (P2) information collected by the Toxics Release Inventory (TRI) Program about projects implemented by companies to eliminate or reduce the creation of chemical waste. According to EPA, community members, local government representatives, facility personnel, and others can access this information through multiple online resources and use it to further the identification and advancement of P2 opportunities. The webinar will include a live demonstration of how to find P2 data for specific facilities, chemicals, and industry sectors, as well as:

  • Details on what data facilities are required to report;
  • Examples of P2 projects implemented at manufacturing facilities; and
  • Resources for and benefits of implementing P2 projects at facilities.

The webinar is also part of a series of webinars to mark the 35th anniversary of the TRI Program. Registration is now open.


 
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