Posted on May 28, 2021 by Lynn L. Bergeson
This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.
This week, I sat down with Heather J. Blankinship, Senior Manager with B&C® Consortia Management (BCCM), a Bergeson & Campbell (B&C®) affiliate, and Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to discuss chemical testing under the Toxic Substances Control Act (TSCA). Since Congress amended TSCA in 2016, the U.S. Environmental Protection Agency (EPA) has been slowly ratcheting up required chemical testing under TSCA Section 4. Congress gave EPA expanded testing authority under the 2016 Amendments, and EPA is exercising its new authority to compel chemical data production. These test orders authorize EPA to demand the production of new test data by the manufacturers and sometimes processors of the chemical substances at issue. Transactionally, this means that competitors in the marketplace band together to generate the data EPA seeks. We discuss the reality of quickly forming these consortia and the business and scientific challenges consortia managers face in complying with these federally enforceable test orders. It is not as easy as you may think!
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Posted on December 09, 2020 by Lynn L. BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers. International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM). According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.” Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
Within 15 business days of receiving a facially complete request, EPA must notify the public of receipt of the request under 40 C.F.R. Section 702.37(e)(2). Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment. The docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions. During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion. After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).
Posted on August 27, 2020 by Lynn L. BergesonBy Lynn L. Bergeson and Carla N. Hutton
On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released an interim final list of businesses subject to fees for the 20 chemicals designated as high priority for risk evaluation under the Toxic Substances Control Act (TSCA). EPA notes that the interim list is an updated version of the preliminary list released in January 2020. According to EPA, making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy and provides time for businesses to engage in initial outreach regarding the formation of consortia to share in fee payments. As reported in our January 29, 2020, blog item, EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged. 85 Fed. Reg. 4661. During the comment period, manufacturers (including importers) were required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA. EPA used this information, along with feedback received during the public comment period, to develop the interim final list.
EPA states that it will publish the final list of businesses subject to fees for the 20 high-priority chemicals concurrently with the release of the final scope documents for these chemicals. Companies on the final list are subject to a portion of the TSCA fee for these risk evaluations and have 60 days to notify EPA of the formation of consortia. According to EPA, it plans to begin invoicing for the fees after those 60 days have passed. Due to the public health emergency, EPA states that it is exploring options for payment flexibilities. Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”
Posted on May 28, 2020 by Lynn L. BergesonBy 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.”
Posted on April 17, 2020 by Lynn L. BergesonBy Lynn L. Bergeson and Carla N. Hutton
On April 16, 2020, the U.S. Environmental Protection Agency (EPA) hosted a call on its recently announced plan to reduce the burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations. The call covered:
- How EPA’s plan to initiate a rulemaking to consider proposing exemptions to the current rule’s requirements impacts manufacturers and other businesses;
- What the “No Action Assurance” means for importers of articles and producers of byproducts and impurities; and
- Reporting obligations during the current comment period, which will close May 27, 2020.
EPA announced on March 25, 2020, that plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:
- Import the chemical substance in an article;
- Produce the chemical substance as a byproduct; or
- Produce or import the chemical substance as an impurity.
During the call, EPA stated that it expects to begin rulemaking in the short term with the goal of issuing a final rule by October 1, 2021. As a bridge to the final rule, EPA issued a “No Action Assurance” for these three categories of manufacturers. EPA will not pursue enforcement action against entities in these manufacturer categories for failure to self-identify under 40 C.F.R. Section 700.45(b)(5).
EPA has posted frequently asked questions (FAQ) about TSCA fees for EPA-initiated risk evaluations. The current FAQs include:
March 2020 Rulemaking Announcement and No Action Assurance
- Why is EPA announcing its intention to propose exemptions to the TSCA fees rule?
- What is the expected timing for this rulemaking?
- Is EPA considering any other changes to the TSCA fees rule as part of this rulemaking?
- What does the “No Action Assurance” mean?
- Do entities in the three categories in the planned regulatory change still have to self-identify during the comment period closing on May 27, 2020?
- Are entities in the three categories impacted by the planned regulatory change still responsible for paying a portion of the risk evaluation fee?
- What should I do if I’ve already self-identified as a manufacturer, but fall into one of the three categories in the planned regulatory change?
- What should I do if I’ve been identified on a Preliminary List, but fall into one of the three categories in the planned regulatory change?
- What should I do if I fall into one of the three categories in the planned regulatory change, but have NOT yet self-identified and was NOT identified on a Preliminary List?
- What constitutes an “article” for purposes of the planned regulatory change?
- What constitutes a “byproduct” for purposes of the planned regulatory change?
- What constitutes an “impurity” for purposes of the planned regulatory change?
Reporting for TSCA Fees
- What do I have to do if my entity was erroneously on a Preliminary List?
EPA has posted the slides for the call. EPA states that it will post a transcript of the call on its website.
Resources
Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggested that industry stakeholders that believe they may be impacted by the January 27 notice may wish to consider suspending ongoing internal deliberations on self-reporting obligations until EPA provides additional guidance.
Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”
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.”
More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”
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