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By Lynn L. Bergeson and Carla N. Hutton
 
On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with the Office of Chemical Safety and Pollution Prevention (OCSPP), proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA.

EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.

EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

  • Using data to develop predictive models and use of predictive models in data-poor environments:
    • Read across and analogue selection;
    • Chemical structures and cheminformatics; and
    • Quantitative structure-activity relationships (QSAR);
  • Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:
    • Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
    • Reference data curation to support validation;
  • Computational modeling, bioinformatics, and/or statistics;
  • Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);
  • Systems biology;
  • Human health and ecological risk assessment;
  • Exposure modeling and/or assessment, including near-field and far-field sources;
  • Knowledge of TSCA; and
  • Environmental fate of chemicals.

Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:

  • Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
     
  • Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
     
  • Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
     
  • Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances;
     
  • Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.

More information on EPA’s draft document is available in our March 14, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA has posted the following presentations from the April 20-21, 2022, meeting:

More information on the meeting is available in our April 22, 2022, memorandum, and more information on EPA’s draft document is available in our March 14, 2022, memorandum. Written comments on the draft document are due May 10, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has placed a March 29, 2022, memorandum correcting the deadline for public comment on the Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemicals. The memorandum states that EPA is clarifying the deadline because the February 25, 2022, Federal Register notice erroneously referenced two different dates. The 60-day comment period on the supporting technical document began when EPA added the document to the docket on March 10, 2022. Comments are due May 10, 2022. More information on EPA’s supporting technical document, “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” is available in our March 14, 2022, memorandum.
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our February 28, 2022, blog item, on February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. On March 25, 2022, the TSCA New Chemicals Coalition (NCC) sent a letter to Michal Ilana Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), regarding its concerns with the “phasing out” of the TSCA Inventory correction process. The NCC states that it believes EPA’s decision-making process “would benefit greatly from stakeholder input and urges EPA to suspend the phaseout set to occur on April 26, 2022, and to reconsider the revocation of the 1980 corrections guidelines set to occur May 31, 2022.” According to the NCC, “[‌b]oth decisions invite significant unintended consequences, and stakeholder comment may well provide information that could persuade EPA to go in a different direction.” The NCC urges EPA to address the issues outlined in its letter by suspending its decisions to revoke the guidelines and “phaseout” of the Inventory correction process and seeking comment on its plans.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.
 
The announcement includes:
 
New Chemicals Division Integrated Approach to Biofuels
 
Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.
 
For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).
 
Outreach and Training
 
According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.
 
OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.
 
Other planned outreach and training related to this biofuels initiative include webinars on:

  • TSCA requirements and the PMN process;
  • The TSCA Inventory, nomenclature, and Bona Fide process;
  • New chemicals risk assessments, including applications of the tools, models, and databases; and
  • New chemicals risk management actions, including TSCA Section 5 orders and SNURs.

EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.


 

By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
 
To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
  • Scopes of work for any contracts related to the new chemicals review process;
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.


 

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 August 17, 2021, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Diana DeGette (D-CO), Chair of the Subcommittee on Oversight and Investigations, and Paul Tonko (D-NY), Chair of the Subcommittee on Environment and Climate Change, sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan to request information regarding “concerning reported irregularities” in EPA’s chemical review program. The Committee’s August 17, 2021, press release states that “[a]ccording to recent allegations made by four whistleblowers -- each a current or former staffer in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) -- the OCSPP has for many years downplayed the dangers of new chemicals and inappropriately interfered with risk assessments conducted pursuant to the Toxic Substances Control Act (TSCA).” The press release states that additional reports “have described the interference alleging that OCSPP manipulated the review of dozens of chemicals” to make the chemicals appear safer. EPA employees “were reportedly pressured to downplay evidence of chemicals’ potential adverse effects such as cancer, birth defects, and neurological effects,” and “EPA’s scientific staff were subject to retaliation.”

The August 17, 2021, letter requests a briefing from EPA, as well as written responses to the following issues:

  • Describe EPA’s understanding as to the veracity of the complaints raised by whistleblowers regarding interference in the chemical program. Explain what actions, if any, EPA has taken to look into these allegations.
  • Is EPA considering reevaluating any chemicals in light of concerns that their review process may have been subject to interference or that they may include precursors to per- and polyfluoroalkyl substances (PFAS)? If so, describe the process and timeline for any reevaluation.
  • Does EPA have any ongoing or planned efforts to review and strengthen whistleblower protections? If so, describe these efforts, including the EPA office responsible for these improvements and any associated timelines.

 
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