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 May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos.  The public meeting will be virtual, with participation by phone and webcast only.  There will be no in-person gathering for this meeting.  EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting.  Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting.  Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 4, 2020, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of perchloroethylene.  85 Fed. Reg. 26464.  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be two virtual public meetings of the TSCA SACC, with participation by phone and webcast only, and no in-person gathering.  The first virtual public meeting, on May 5, 2020, will be a preparatory meeting for SACC to consider the scope and clarity of the draft charge questions for the peer review.  This meeting will be followed by the peer review public virtual meeting on May 26-29, 2020, for SACC to consider and review the draft risk evaluation.  EPA will provide any written comments submitted on the draft risk evaluation on or before May 20, 2020, to SACC for their consideration before the meeting.  Comments received after May 20, 2020, and prior to the oral public comment period during the May 26-29, 2020, meeting will be available to the SACC for their consideration during the meeting.  Comments on the draft risk evaluation are due July 6, 2020.  EPA will consider all comments received by the end of the comment period.  More information on EPA’s draft risk evaluation is available in our April 28, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Perchloroethylene.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The risk to consumers from perchloroethylene’s use in dry cleaning is from skin exposure to items cleaned with perchloroethylene.  EPA notes that it also found environmental risks to aquatic organisms.
 
EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation and will provide “frequent updates” on its progress throughout the process.  EPA notes that if its final risk evaluation finds there are unreasonable risks associated with perchloroethylene under the specific conditions of use, EPA will propose actions to address those risks within the time frame required by TSCA.  EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation, beginning a 60-day comment period.  EPA will also hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation May 26-29, 2020.  The virtual peer review meeting is open to the public to attend and provide comments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for that chemical substance.  EPA is also opening a 45-day comment period on these draft scope documents to allow for the public to provide additional data or information that could be useful to EPA in preparing the final scope documents.  Comments are due June 8, 2020.  More information on the draft scope documents is available in our April 21, 2020, memorandum, “EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review.  EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust review of the evaluation.”  As a result, EPA will reschedule the SACC meeting “as soon as practicable.”  EPA notes that while it does not anticipate extending the written public comment period on the draft risk evaluation past June 2, 2020, “as needs arise EPA will review and respond appropriately.”  EPA will provide all written comments received by June 2, 2020, to SACC for their review prior to the meeting.  Once EPA has selected a new date for the SACC meeting, EPA will provide an update on public commenting, including registering to provide oral public comments during the SACC meeting.  EPA states that it “remains committed to completing this process as expeditiously as possible.”  More information on EPA’s draft risk evaluation is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “[‌i]t is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for the following chemicals:

 
EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the second batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.  Our April 7, 2020, memorandum, “EPA Seeks Public Comment on First Batch of Draft Scope Documents,” offers an overview of the draft scope documents on the other 13 of the 20 chemicals undergoing risk evaluation, as well as an insightful commentary.


 

By 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

  1. Why is EPA announcing its intention to propose exemptions to the TSCA fees rule?
  2. What is the expected timing for this rulemaking?
  3. Is EPA considering any other changes to the TSCA fees rule as part of this rulemaking?
  4. What does the “No Action Assurance” mean?
  5. 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?
  6. Are entities in the three categories impacted by the planned regulatory change still responsible for paying a portion of the risk evaluation fee?
  7. 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?
  8. 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?
  9. 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?
  10. What constitutes an “article” for purposes of the planned regulatory change?
  11. What constitutes a “byproduct” for purposes of the planned regulatory change?
  12. What constitutes an “impurity” for purposes of the planned regulatory change?

Reporting for TSCA Fees

  1. 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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call will cover:

  • TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;
     
  • EPA’s March 25, 2020, rulemaking announcement and “No Action Assurance” and the implications for certain manufacturers who:  (1) import a high-priority chemical in an article; (2) produce a high-priority chemical as a byproduct; or (3) produce or import a high-priority chemical as an impurity; and
     
  • Reporting obligations during the current comment period for the preliminary lists of fee payers, closing May 27, 2020.

EPA asks stakeholders to submit questions by April 14, 2020, to Ben Dyson, .(JavaScript must be enabled to view this email address), and EPA will address them during the call.  Additional questions from participants will be answered during the call as time permits.  Registration is now open.

Resource

Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggests 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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2020, that it received a complete manufacturer request for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4) from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center.  EPA states that D4 is used to make other silicone chemicals and as an ingredient in some personal care products.  D4 was identified in the 2014 Update to the TSCA Work Plan.
 
EPA notes that within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), it must notify the public of receipt of this 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.  According to EPA, 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).


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment.  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “it is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation:

EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the first batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.


 
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