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 November 20, 2020, the availability of a supplemental analysis to the draft risk evaluation of 1,4-dioxane under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 74341.  EPA states that it developed the supplemental analysis in response to public and peer review comments on the draft risk evaluation.  The supplemental analysis includes eight consumer uses, including surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer, where 1,4-dioxane is present as a byproduct.  The supplemental analysis also assesses exposure to the general population from 1,4-dioxane in surface water.  In the supplemental analysis, EPA preliminarily found no unreasonable risk to consumers from the eight conditions of use assessed.  EPA also preliminarily found no unreasonable risks under any of the conditions of use to the general population from exposure to 1,4-dioxane.  Comments are due December 10, 2020.  More information on the draft risk evaluation of 1,4-dioxane is available in our July 2, 2019, memorandum.


 

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) will soon announce that the Chemical Data Reporting (CDR) submission period has been extended from November 30, 2020, to January 29, 2021.  A Federal Register notice has been signed, and EPA expects to post a pre-publication version of the notice on its website.  To assist chemical manufacturers and processors with submitting CDR data, Bergeson & Campbell, P.C.’s (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR and, if so, at what reporting threshold.
 
CDR Cross-Check will identify:

  • Whether the chemical is listed as active or inactive;
  • Whether the chemical was subject to specific Toxic Substances Control Act (TSCA) regulatory actions in 2016;
  • Whether the chemical is exempt; and
  • What the reporting thresholds are based on the updated data released by EPA on May 29, 2020.

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 9, 2020, 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 the cyclic aliphatic bromide cluster (HBCD).  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 HBCD.  As reported in our September 28, 2020, memorandum, EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the processing, use, and disposal of HBCD, largely from building and construction materials.  EPA’s website states “EPA did not find unreasonable risks to the general population or consumers.” Nevertheless, in the risk evaluation document, EPA did find unreasonable risk from fish ingestion at the high-end exposure in one scenario.  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 November 23, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and 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 November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns.  In addition to being open to the public, EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.  EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.”  EPA notes that there will also be an open public comment period on proposed risk management regulations.


 

By Lynn L. Bergeson and Carla N. Hutton

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.”  The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”


 

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 Carla N. Hutton
 

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists.  EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case).  If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding.  If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register.  The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations.  Companies that amend, update, or file new CBI substantiations must do so electronically via EPA’s Central Data Exchange.

Background

On March 6, 2020, EPA promulgated a final rule on procedures for review of CBI claims made under TSCA.  The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities.  The substantiation requirements describe the applicable procedures and provide instructions for regulated entities.  EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year timeframe set in TSCA.  More information is available in our February 28, 2020, memorandum, “EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”

Tags: CBI, NOA, Inventory

 
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