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) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly-accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar will provide an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application. Registration is open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our July 18, 2022, blog item, the U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” In a September 14, 2022, letter, EPA denied the petition. According to the letter, of the various actions described in the petition, EPA determined that only the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) is within the ambit of a TSCA Section 21 petition. EPA states that based on its review, and after careful consideration of the specific requests, it is denying the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) because, “although EPA shares the petitioners’ concerns regarding the threat posed by climate change, the Agency found that the petition was insufficiently specific and failed to establish that it is necessary to issue a rule under TSCA section 6, in light of ongoing and expected federal government actions, the relative efficiency of TSCA rulemaking, and lack of TSCA section 6(a) authority to regulate historical GHG emissions.” EPA will publish in a forthcoming Federal Register notice its reasons for denying this portion of the petition, as well as its reasons for declining to address under TSCA Section 21 the other petitioned actions. EPA has posted a prepublication copy of the Federal Register notice.


 

By Lynn L. Bergeson 

Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit the U.S. Environmental Protection Agency’s (EPA) authority in implementing Congress’s 2016 amendments to the Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).
 
The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) for Chemical Watch, is available here.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from fluorinated polyethylene food containers. The purpose of the request is to ensure that FDA has current information to support its review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe. According to the RFI, FDA may use submitted information to update dietary exposure estimates and safety assessments for the authorized food contact use of fluorinated polyethylene. Either electronic or written comments and scientific data and information are due October 18, 2022.
 
The RFI notes that tests performed by the U.S. Environmental Protection Agency (EPA) found that certain PFAS can form and migrate from some fluorinated high-density polyethylene (HDPE, which is a type of polyethylene) containers into the pesticide within the containers. EPA’s testing was conducted on containers that are not FDA-regulated, specifically containers intended to hold mosquito-controlling pesticides. The RFI states that EPA’s testing raises questions about the potential for PFAS to form and migrate from fluorinated polyethylene containers that are intended for food contact use. As such, FDA is interested in obtaining information on current food uses of fluorinated polyethylene containers, as well as information on current manufacturing processes for these containers and any analytical testing information about substances that may migrate from fluorinated polyethylene containers to food. More information on EPA’s testing is available in our October 4, 2021, blog item.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, July 27, 2022, from 1:00 - 2:00 p.m. (EDT). During the webinar, EPA will provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) before taking questions from the audience. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under the Toxic Substances Control Act (TSCA) and common issues that cause EPA to have to rework risk assessments for these submissions.
 
Registration for the July 27, 2022, webinar is open. According to EPA, subsequent webinars over the coming months will communicate its considerations in evaluating qualitative claims or quantitative data, especially when they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) and its considerations for evaluating information about sites not controlled by the submitter. EPA will release information about these webinars, including dates and instructions on how to register, as it becomes available.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” EPA acknowledged receipt of the petition in a July 5, 2022, letter. Under TSCA Section 21, EPA has 90 days to grant or deny the portions of the petition eligible for TSCA Section 21. If EPA grants the petition, then EPA “will promptly commence an appropriate proceeding.” If EPA denies the petition in whole or in part, then it will publish the reasons for denial in the Federal Register.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on integrating climate change information into risk assessments at nonfederal Superfund sites, as well as other actions. GAO states that it is not adding any additional priority recommendations this year. The total number of priority recommendations remaining is 12. These recommendations involve the following areas:

  • Assessing and controlling toxic chemicals;
  • Reducing pollution in the nation’s waters;
  • Ensuring cybersecurity at EPA;
  • Addressing data and risk communication issues for drinking water and wastewater infrastructure;
  • Managing climate change risks; and
  • Protecting the nation’s air quality.

According to GAO, EPA’s continued attention to these issues could lead to significant improvements in government operations.
 
Regarding assessing and controlling toxic chemicals, GAO states that EPA’s ability to help protect public health and the environment effectively “depends on credible and timely assessments of risks posed by toxic chemicals,” including per- and polyfluoroalkyl substances (PFAS). According to GAO, by implementing the following four priority recommendations in this area, EPA would improve its ability to prepare and issue Integrated Risk Information System (IRIS) chemical assessments:

  • To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in GAO’s 2008 report and “ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database.”
  • To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders.
  • The EPA Administrator should direct the Assistant Administrator of ORD to provide more information publicly about where chemical assessments are in the development process, including internal and external steps in the process, and changes to assessment milestones.
  • The EPA Administrator should include in ORD’s strategic plan (or subsidiary strategic plans) identification of EPA’s universe of chemical assessment needs; how the IRIS Program is being resourced to meet user needs; and specific implementation steps that indicate how IRIS will achieve the plan’s objectives, such as specific metrics to define progress in meeting user needs.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 7, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled “The EPA Was Not Transparent About Changes Made to a Long-Chain PFAS Rule After Administrator Signature.” OIG evaluated 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 (LCPFAC) significant new use rule (SNUR) between the EPA Administrator’s signing of the final rule on June 22, 2020, and the publication of the final rule in the Federal Register on July 27, 2020. OIG states that it initiated the evaluation based on a Congressional request. OIG notes that the substances in question are types of per- and polyfluoroalkyl substances (PFAS), which are manufactured chemicals widely used in industry and consumer products. SNURs require that EPA be notified before regulated chemical substances are used in new ways that might cause environmental or human health concerns.
 
According to OIG, EPA did not follow all applicable policies, procedures, and guidance when making changes to the LCPFAC SNUR after the Administrator signed it and before it was published in the Federal Register. Specifically:

  • Although EPA identified changes made to the SNUR in a post-signature change memorandum, which was signed by the Administrator, as required by EPA’s Changes to Rule Documents Prepared for the Administrator’s Signature procedures, EPA did not docket that memorandum, as stipulated in EPA’s Creating and Managing Dockets: Frequently Asked Questions for EPA Action Developers guidance.
     
  • OIG states that because the request for changes was communicated via telephone, it could not identify the origin of the requested changes and could not determine whether EPA complied with the transparency provisions of Executive Order 12866, Regulatory Planning and Review.

OIG states that by not following all docketing procedures, EPA did not meet transparency expectations and risked compromising the public’s trust in the rulemaking process. OIG notes that EPA followed the Office of the Federal Register’s Document Drafting Handbook guidance for requesting changes to the final rule, however.
 
OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention update the LCPFAC SNUR docket by posting the post-signature change memorandum that outlines the changes made to the final rule after the Administrator signed it but before it was published in the Federal Register. OIG also makes two recommendations to the Associate Administrator for Policy, which include updating the applicable policies, procedures, and guidance regarding making changes to a regulatory action after it is submitted to the Office of Information and Regulatory Affairs for review and before it is published in the Federal Register. OIG states that EPA agreed with its first two recommendations and provided acceptable corrective actions. The first recommendation is completed, and the second is resolved with corrective actions pending. EPA disagreed with OIG’s third recommendation, and it remains unresolved. More information on the LCPFAC SNUR is available in our July 27, 2020, memorandum.

Tags: OIG, PFAS, LCPFAC, SNUR,

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released on June 30, 2022, a report entitled “Additional Internal Controls Would Improve the EPA’s System for Electronic Disclosure of Environmental Violations.” OIG conducted the evaluation to determine whether EPA’s process for screening self-reported violations through its electronic disclosure, or eDisclosure, system is effective and ensures that significant concerns, such as criminal conduct and potential imminent hazards, are addressed by the Office of Enforcement and Compliance Assurance (OECA). According to OIG’s report, the goal of the eDisclosure system is to provide an efficient mechanism for regulated entities to self-disclose violations of federal environmental laws and regulations. Self-disclosed violations are automatically processed under the EPA’s audit policies. EPA subsequently screens certain eDisclosure submissions to ensure that significant concerns, such as criminal conduct and potential imminent hazards, are properly addressed.
 
OIG states that the eDisclosure system does not have adequate internal controls in place to ensure that EPA’s screening process is effective and that significant concerns, such as criminal conduct and potential imminent hazards, are identified and addressed by OECA and the EPA regions. OIG notes that there is no formal, written national guidance or eDisclosure-specific training available on how EPA staff should conduct screening or delineate staff responsibilities. According to OIG, as a result, most regions inconsistently screen for significant concerns or do not screen at all because they believe OECA is responsible for that task, do not have access to the eDisclosure system, or have other resource limitations. Further, EPA does not have performance measures and does not systematically track eDisclosure system data. Finally, OIG states the eDisclosure system’s reporting tool “does not allow staff to effectively or robustly use or track eDisclosure submissions.” OIG concluded that without national screening guidance, training, effective monitoring, and Central Data Exchange improvements, there is a risk that significant concerns are not being addressed and that the impacts of the EPA’s eDisclosure system will remain limited and unknown.
 
OIG recommends that the OECA Assistant Administrator develop national guidance that includes a process for screening eDisclosure submissions for significant concerns; provide eDisclosure-specific training to EPA headquarters and regions to clarify expectations, establish staff responsibilities, and communicate best practices; develop performance measures for the eDisclosure system, as well as a monitoring plan to track its effectiveness; and assess eDisclosure system functionality to identify and implement improvements. According to OIG, OECA agreed with all four of its recommendations and proposed acceptable corrective actions and estimated completion dates. All recommendations are resolved with corrective actions pending. Where appropriate, OIG revised the report based on technical comments provided by OECA.


 

Wednesday, August 3, 2022
12:00 p.m. - 1:00 p.m. (EDT)

Register Today

The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”

These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:

  • Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
  • Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions; 
  • Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
  • Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.

Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH, as Bergeson & Campbell, P.C. (B&C®) presents “TSCA New Approach Methodologies.

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.

James W. Cox, M.S., Senior Scientist, B&C, developed risk assessments and advised on hazard characterization processes under TSCA while working as Acting Lead Biologist in EPA’s OPPT New Chemicals Division. While at EPA, he helped develop a framework to complete risk assessments for novel petroleum alternatives and evaluated the hazard and risks to human health from exposure to industrial chemicals, biological agents, and nanomaterials.

Kristie Sullivan, MPH is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), a nationwide organization of physicians and laypersons that promotes preventive medicine and ethics in research. As Vice President of Research Policy, Ms. Sullivan directs PCRM’s efforts to promote human-relevant alternatives to the use of animals in medical research, education, and the testing of drugs, chemicals, and other products through scientific scholarship and outreach to companies, federal agencies, legislators, and others. Ms. Sullivan has 15 years’ experience in legislative, policy, science, and training activities related to the implementation of New Approach Methodologies, including by engaging with EPA, the Organization for Economic Cooperation and Development, and the regulated industry.

Register Now


 
 1 2 3 >  Last ›