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 Margaret R. Graham, M.S.
On April 17, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of updated systematic review supplemental files with data evaluation scoring sheets as supporting documents for the draft risk evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 16011. EPA states it is “seeking public comment on the draft risk evaluation for PV29 in light of the additional materials already made or being made publicly available.” In her April 16, 2019, blog item, Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, described the updated systematic review documents for PV29 as “a tool that guides our review and selection of scientific studies used to evaluate chemicals,” and that the updates were made “based on public input we received during the initial comment period.”
On March 22, 2019, EPA made 24 full study reports on PV29 available to the public, in some instances with information withheld as confidential business information (CBI) pursuant to EPA regulations. EPA has considered these materials in the risk evaluation process of PV29 and has also submitted these materials to the TSCA Science Advisory Committee on Chemicals (SACC). EPA states that comments submitted will be considered by the agency and also provided to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions.
The comment period for the draft risk evaluation of CI PV29 closed on January 14, 2019, but via this notice is being extended. The Federal Register notice announcing the availability of the updated systematic review supplemental files lists a comment deadline of the same date as the notice -- April 17, 2019, but Docket ID EPA-HQ-OPPT-2018-0604-0038, however, lists a comment deadline of May 17, 2019; it is most likely that the docket is correct in this instance especially considering that follows what was stated by Ms. Dunn in her blog item that in light of the new and updated information EPA has recently released, "we will be reopening the public comment on the draft risk evaluation for PV29. It is important that the public have the opportunity to provide input on all of the information EPA is considering before our risk evaluation is finalized, so we invite you to provide us with your feedback. The public comment period will reopen for 30 days following publication in the Federal Register.”
By Lynn L. Bergeson and Margaret R. Graham
On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days; comments on these documents are now due by August 16, 2018. EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try to consider any additional comments received after this date. However, incorporation of late comments may not be included in the documents for peer review. There will be an additional comment period following the publication of each of the draft risk evaluations.”
Links to the problem formulation dockets are available in our blog item “EPA Releases Problem Formulations Documents on First Ten Chemicals; Systematic Review Approach Document; and Asbestos SNUR” and a more detailed analysis is available in our memorandum “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety.”
By Lynn L. Bergeson and Margaret R. Graham
On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment. Links and short summaries are provided below.
EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019. Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register. The problem formulation documents are:
- 1-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- Trichloroethylene (TCE).
EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information. Comments will be due 45 days after publication in the Federal Register. Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.
For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos. EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use. Comments will be due 60 days after publication in the Federal Register.
More information on the first ten chemical evaluations is available on our blog. A more detailed analysis will be available next week on our regulatory developments webpage.