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By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2021, the U.S. Environmental Protection Agency (EPA) began environmental justice consultations regarding the development of risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) for Asbestos, Part 1: Chrysotile Asbestos and Pigment Violet 29 (PV29). EPA will hold two identical consultation webinars, on June 1, 2021, and June 9, 2021. EPA states that it is offering these repeated sessions to increase opportunities for participation. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from Asbestos, Part 1: Chrysotile Asbestos and PV29, and an opportunity for input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. The environmental justice consultation period end August 13, 2021.

EPA states that in addition to these environmental justice consultations, it is implementing a “robust outreach effort” on risk management that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management actions. More information on EPA’s final risk evaluation for Asbestos, Part 1: Chrysotile Asbestos is available in our January 4, 2021, memorandum and on EPA’s final risk evaluation for PV29 in our January 25, 2021, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for C.I. Pigment Violet 29 (PV29).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for PV29.  As reported in our January 25, 2021, memorandum, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used primarily in the automobile industry, in ink used for commercial printing, and in consumer watercolors and artistic paints.  EPA determined that there are unreasonable risks to workers and occupational non-users (ONU) from ten out of 14 conditions of use.  EPA found no unreasonable risks to the environment, consumers, or the general public.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by March 5, 2021.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulation.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 9, 2021, that it will host two webinars intended to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluations for pigment violet 29 (PV29) and n-methylpyrrolidone (NMP).  The webinars will also allow the public to provide input on considerations EPA should take into account for managing any unreasonable risks found with these chemicals.  The PV29 webinar will be held on February 23, 2021, and the NMP webinar will be held on February 24, 2021.  To provide oral comments during the PV29 webinar, registration is due by February 18, 2021.  To provide oral comments during the NMP webinar, registration is due by February 19, 2021.
 
EPA states that it will also hold formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  EPA notes that there will also be an open public comment period on any draft risk management regulation.  According to EPA, while outreach and stakeholder engagement on risk management activities for these chemicals will continue to move forward, EPA “is actively reviewing the final risk evaluations to ensure that they use the best available science and protect of human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.”  EPA “will keep stakeholders updated as decisions are made, and next steps are determined.”


 

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) has extended the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 (PV29).  85 Fed. Reg. 74718.  As reported in our October 29, 2020, blog item, EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Comments are due December 19, 2020.
 
EPA will use feedback from the public comment period to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA, these new data led EPA to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  EPA states that because the new data had a significant impact on its risk evaluation and ultimately the risk determinations, it is providing an opportunity for the public and independent scientific experts to give input before the risk evaluation is prepared in final.
 
EPA will publish a Federal Register notice on October 30, 2020, beginning a 30-day comment period.  During the public comment period, EPA states that it will also conduct 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 will focus on charge questions supplied by EPA, and EPA states that “the public is encouraged to focus their comments on those issues as well.”
 
EPA will use feedback received from the letter peer review and public comment process to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed. Reg. 20354.  The meeting may also be available via webcast.

EPA states that the purpose of the SACC meeting is for EPA “to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment, and risk characterization.”  Additionally, this meeting will include an orientation on TSCA and how EPA is evaluating chemicals in commerce as prescribed in amended TSCA.  EPA states that it will use the scientific advice, information, and recommendations from the SACC, as well as public comments, to inform the final risk evaluation.  Comments are still being collected on the PV29 risk assessment until May 17, 2019, in Docket No. EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

More information about the June SACC meeting and peer review of PV29 is available on EPA’s website.