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) is accepting public comments on the experts under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  Comments are due August 21, 2020.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA expects to appoint approximately 15 members to SACC by March 2021.

Tags: SAAC, Comments

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 32036.  The new due date is June 15, 2020.  EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations.  EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.

EPA held a conference call on TSCA fees on April 16, 2020, and posted the slides and transcript for the call.  EPA’s web page on TSCA fees for EPA-initiated risk evaluations includes frequently asked questions.  Our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia,” provides information on forming a consortium.  More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”


 

By Christopher R. Blunck
 
As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  In the comments, linked to in EDF’s May 14, 2020, blog item on the subject (the comments are not yet posted to the EPA dockets), the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require to be included, and then make the revised draft scopes available for public comment.  In their comments, the NGOs note that TSCA Section 6(b)(4)(D) requires that EPA, “not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” (emphasis added) and that under EPA’s risk evaluation rule at 40 C.F.R. Section702.41(c), the scope of a risk evaluation must, among other things, identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate;
     
  • The hazards to health and the environment that EPA plans to evaluate; and
     
  • The “reasonably available information” on which EPA relies to identify these required scope elements.
The NGOs state that EPA regulations at 40 C.F.R. Section 702.41(c)(7) make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  According to the NGOs, despite the regulatory requirements, EPA has not addressed the specific obligations and “Instead, EPA has only generally described some broad categories of hazards, exposures, and potentially exposed or susceptible subpopulations, and has suggested it will identify the specific hazards, exposures, and subpopulations -- and the reasonably available information it relies on to identify them -- only later, well after the current comment periods have closed and possibly even after the scopes are finalized.”  This, the NGOs state, is not allowed under TSCA and the TSCA risk evaluation rule.
 
Furthermore, the NGOs state that EPA also refers in each draft scope to “systematic review documentation” that has not yet been made public.  While EPA states it plans to publish this second document prior to issuing the final scope document, and take comment on it, the comments state that “EPA has wholly divorced any public comment opportunity it will provide on that systematic review document from the current public comment opportunity” and “[g]iven that the systematic review document is not yet available, the public is unable to consider its content in preparing comments on the draft scope document.”
 
The NGOs indicate that given these faults, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  They request EPA simultaneously to publish and take comment on, for a period of no less than 30 days, revised draft scope documents that reflect the planned systematic review, and the systematic review documentation for each scope.
 
We agree that the faults identified by the NGOs on the draft scope documents and the associated process are significant and that if not remedied, any risk evaluations with scopes founded on the drafts would be legally vulnerable as not comporting with TSCA and EPA’s risk evaluation rule.  EPA may wish to consider taking corrective measures along the lines urged.  This change would include adding into revised draft scopes for comment the reasonably available information EPA has indicated it will identify through the yet-to-be-completed systematic review process, and will identify the specific hazards, exposures, and potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations.
 

 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed supplemental significant new use rule (SNUR) issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  85 Fed. Reg. 12479.  Under the proposed supplemental SNUR, this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.  Comments on the proposed supplemental SNUR are due April 17, 2020.  More information is available in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles.”

 

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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 April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  Comments on the proposed rule are due April 27, 2018.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) is available in our memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

 


 

By Lynn L. Bergeson and Margaret R. Graham

On December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  Comments were initially due on December 9, 2017; they are now due on January 12, 2018.  EPA states it is interested in information from the public about these chemicals, including uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  Very few comments have been filed regarding these chemicals thus far.  The chemicals and corresponding docket numbers are:

More information on the PBTs is available on our blog under keyword PBTs.

 


 

By Lynn L. Bergeson and Margaret R. Graham

On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals.  EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  The deadline to submit comments is fast approaching:  December 9, 2017.  The five chemicals and their corresponding dockets are:

In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents which provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical.  Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed. 

More information on the PBTs is available on our blog under keyword PBTs.


 
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