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) announced on July 21, 2022, that the meeting minutes and final report (final report) are now available for the April 19-21, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances Version 1.0 (Draft Protocol). As reported in our December 21, 2021, memorandum, EPA released the Draft Protocol for public comment on December 20, 2021. 86 Fed. Reg. 71891. According to EPA’s December 20, 2021, press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment. EPA intends to issue its response to the SACC’s recommendations along with any revisions to the approach in 2023.

Charge Question 1: TSCA Systematic Review Protocol Document (Chapters 1-7)

The final report states that the SACC raised some substantive comments that require edits or explanation from EPA. According to the SACC, the Draft Protocol “is closer to a framework to carry out systematic review and other evaluation processes for TSCA risk evaluation.” Multiple SACC members recommended specifying systematic review and non-systematic review processes (e.g., risk assessment) within the Draft Protocol. To increase transparency, the Draft Protocol needs to: (1) start with the problem formulation; (2) describe how Populations, Exposures, Comparators, and Outcomes (PECO) or Receptors, Exposure, Setting or Scenario, and Outcomes (RESO) statements are developed and refined through the process; (3) describe the process of systematic review, evidence synthesis, and integration; and (4) clearly link the steps of the systematic review back to the larger risk evaluation process.

Charge Question 2: Strategies for Literature Search and Screening (Chapter 4)

According to the final report, overall, the SACC found the methods for searching and screening well described in Chapter 4. The general process for searching the peer-reviewed literature was considered robust, but the SACC noted concerns that methods for searching gray literature were neither robust nor complete. The method for searching gray literature does not currently find relevant information from states, non-governmental organizations (NGO), or community groups. The SACC recommends EPA identify authoritative reviews from government agencies and begin with these as a starting point to make more efficient use of time and resources.

Charge Question 3: Method to Assess the Quality of Evidence (Chapter 5)

The final report states that in general, the SACC noted that the Draft Protocol is an improved approach compared with the 2018 method. There was greater transparency and clarity in the data evaluation methods, as EPA’s process for evaluating the data across various evidence streams was well described and explained. The SACC made several recommendations to include more detail regarding the role of certain evidence types, such as biochemical and cellular-level outcomes, and to describe how supplemental data sources will be reviewed, evaluated, and incorporated into the systematic review or what criteria will be used to make the determination to consider/incorporate these data. In addition, EPA should re-evaluate the domain “accessibility” and identify whether an alternative term or phrase would be more appropriate to capture the elements under consideration. The SACC stated that EPA should be specific about the types of quality and validity issues it is considering and maintain appropriate categorizations of each instead of referring to them collectively under a blanket term.

Charge Question 4: Approaches for Integrating Evidence in Exposure and Hazard (Chapter 7)

According to the final report, SACC agreed this is a difficult and multi-faceted task and generally found that several aspects of the chapter were helpful, such as the hierarchies of data and the documentation on integration. As written, the Draft Protocol presents a complicated and potentially inefficient method for integrating data within the various disciplines, however. The final report states that many SACC members were concerned that criteria used to judge quality may exclude useful data that are not of high quality but nevertheless may have specific value for other downstream applications (e.g., corroboration of results or to assist with coherence of a data stream). In addition, the evidence integration process inappropriately introduces criteria for data selection that should be specified earlier in the process.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 10, 2022, that registration is now open for the April 19-21, 2022, virtual meeting of the Science Advisory Committee on Chemicals (SACC). During the meeting, SACC will peer review the draft Toxic Substances Control Act (TSCA) Systematic Review Protocol. SACC’s virtual meeting is open to the public, and registration is required. EPA states that the draft Protocol, released in December 2021 for public comment, incorporates changes to address the recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM), as well as comments received from SACC and the public. According to EPA, the SACC review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” Stakeholders wishing to provide oral comments during the virtual meeting must register by 12:00 p.m. (EDT) on April 4, 2022. Stakeholders may register as listen-only attendees at any time until the end of the meeting on April 21, 2022. More information on the draft Protocol is available in our December 21, 2021, memorandum.


 
By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 28, 2022, the implementation of a new process by which the Science Advisory Board (SAB) will assess the science that informs decisions regarding EPA proposed rules. EPA states that the new process “will restore opportunities for peer review and strengthen the independence of” SAB. According to EPA, the new Science Supporting EPA Decisions process strengthens peer review at EPA by:
  • Restoring SAB’s role by having structured opportunities to conduct peer review of critical scientific and technical actions developed by EPA;
     
  • Strengthening the independence of SAB’s role by scoping and identifying the peer review need for EPA decisions;
     
  • Ensuring EPA considers and develops peer reviewed science early in its rule-making development process; and
     
  • Restoring public faith in EPA by ensuring the use of peer reviewed science to inform decision making.
The process is effective immediately. EPA posted a February 28, 2022, memorandum from Associate Administrator for Policy Victoria Arroyo, Deputy Assistant Administrator for the Office of Research and Development Christopher Frey, and Director of the SAB Staff Office Thomas Brennan that outlines the new process. EPA notes that the memorandum “was issued at the direction of the Administrator and supersedes prior procedures.”

 

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
 
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.

Tags: PFAS, LVE, Review

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 27, 2021, “important policy shifts in its review of new [per-and polyfluoroalkyl substances (PFAS)] before they can enter the market.”  According to EPA, although some new PFAS have been allowed to enter the market through low volume exemptions (LVE), EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS.  EPA states that due to the scientific complexities associated with assessing PFAS, and the hazard potential associated with various sub-classes of PFAS, “it is challenging to conduct an appropriately robust review of LVE requests for PFAS in the 30 days the regulations allow.”  Under the regulations, EPA can deny LVE requests if it finds the chemical may cause serious human health effects or significant environmental effects or when issues concerning toxicity or exposure require review that cannot be completed in 30 days.  According to EPA, “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE submission for a PFAS is unlikely to be eligible for this kind of exemption under the regulations.”  While EPA will consider each LVE application individually, it “generally expects” that it will deny pending and new LVE submissions for PFAS.  This will allow EPA more time to conduct a more thorough review and, as appropriate, “put measures in place to mitigate the potential risk of these chemicals as the agency determines whether to allow them to enter commerce.”  EPA states that in addition, it is “exploring ways to work cooperatively with companies to voluntarily withdraw previously granted LVEs.”  EPA states that this “would build upon a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that existed at the time.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our February 17, 2021, blog item, on February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  In its final report, the Committee to Review EPA’s TSCA Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the Integrated Risk Information System (IRIS) Program.  In their March 4, 2021, press release, the Republicans state that the IRIS Program “has come under fire from Congress and independent reviewers like the National Academies for its inconsistent process, lack of transparency, and failure to complete assessments in a timely fashion.”  The Republicans ask for EPA’s commitment that, “in accordance with congressional intent to operate with flexibility and speed, TSCA does not fully or consistently adopt program processes or procedures implemented by IRIS.”  If EPA incorporates elements developed by the IRIS Program into TSCA, the Republicans “expect the Agency to assess their benefits and impacts thoroughly, while also adhering to the statutorily prescribed deadlines and scientific standards mandated.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604.  EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk evaluation.
 
According to EPA, after it issued the draft risk evaluation in November 2018, it received additional data in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA states that these new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  As a result of this updated analysis, the revised draft risk evaluation now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Because these new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, EPA provided an opportunity for the public to give input before issuing the final risk evaluation.
 
EPA notes that it also conducted a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review focused on charge questions supplied by EPA.  The report made available December 21, 2020, is the result of this letter peer review.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.


 
 1 2 3 >  Last ›