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.
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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.


 
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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.”


 
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Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.

Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies.  Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.

The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell”  Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:

All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.  All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music.  Subscribe so you never miss an episode. 


 
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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.”


 
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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.


 
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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.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is hosting the following webinars to educate scientists on the more than 30 federal opportunities available in Research Triangle Park, North Carolina:

Webinar participants will learn about OCSPP’s role in protecting human health and the environment, OCSPP’s newly formed worksite located in Research Triangle Park, and the more than 30 scientific positions for which OCSPP is recruiting.  The webinar will also cover finding and applying to EPA jobs, creating profiles and saving searches on USAJobs, education and transcripts requirements for scientific positions, and the federal general schedule (GS) pay scale, benefits, and retirement.

Tags: OCSPP, Webinar

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published on April 10, 2020, the quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020.  In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available.  EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.”  According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.”  The updated statistics show EPA’s progress toward meeting these requirements.

Tags: CBI

 
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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.”


 
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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).


 
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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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By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule.  EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.”  The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
     
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
     
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
     
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020.  85 Fed. Reg. 15396.  EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.”  On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020.  EPA anticipates promulgating a final rule later in 2020.  More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on April 2, 2020, that it sent a letter to all members of Congress to correct the record on its temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic.  EPA states that “[a]s should be apparent to anyone who reads the policy, allegations that EPA ‘will cease all enforcement actions during the coronavirus pandemic’ and that the temporary policy ‘absolves polluters of all responsibility’ are simply not true.”  According to EPA, it expects regulated entities to comply with all obligations, and if they do not, EPA emphasizes that the policy says EPA will consider the pandemic, on a case-by-case basis, when determining an appropriate response.  Furthermore, in cases that may involve acute risks, or imminent threats, or failure of pollution control or other equipment that may result in exceedances, “EPA’s willingness to provide even that consideration is conditioned on the facility contacting the appropriate EPA region, or authorized state or tribe, to allow regulators to work with that facility to mitigate or eliminate such risks or threats.”

EPA states that it is “not unusual for EPA to exercise enforcement discretion to address emergency situations that disrupt normal operations, such as hurricanes.  What is unusual is that the current crisis caused by the COVID-19 pandemic affects the entire nation,” rather that a discrete geographic area.”  According to EPA, it developed the temporary policy to allow it to prioritize its resources to respond to acute risks and imminent threats, rather than making case-by-case determinations regarding routine monitoring and reporting.  EPA notes that the development of the policy was a group effort, involving “multiple calls” and with “drafts shared among EPA staff and managers, both career and political, at both headquarters and in the regions.”  Once the COVID-19 threat has ended, “EPA expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible.”  Additionally, according to EPA, “the policy makes clear that EPA expects operators of public water systems to continue normal operations and maintenance during this time, as well as required sampling, to ensure the safety of vital drinking water supplies.”

More information on EPA’s temporary policy is available in our March 27, 2020, blog item, “EPA Announces Temporary Enforcement Discretion Policy.”


 
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The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020.  EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk:

  • EPA did not find risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment under any of the conditions of use.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders.  EPA found that workers, occupational non-users, consumers, and bystanders could be adversely affected by asbestos under certain conditions of use.

EPA states that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not final determinations on whether asbestos presents unreasonable risks under the conditions of use.  EPA will use feedback received from the public comment and peer review processes to inform the final risk determinations.


 
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