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.

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

In the US, all new chemicals must be reviewed by the US EPA before they can enter commerce. The agency looks at new chemicals to determine whether their manufacturing, processing and use would adversely affect people or the environment. If the EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through the EPA for review and have been allowed into US commerce.

In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, 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 C.I. Pigment Violet 29 (PV29).  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 PV29.  As reported in our January 25, 2021, memorandum, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used primarily in the automobile industry, in ink used for commercial printing, and in consumer watercolors and artistic paints.  EPA determined that there are unreasonable risks to workers and occupational non-users (ONU) from ten out of 14 conditions of use.  EPA found no unreasonable risks to the environment, consumers, or the general public.  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 March 5, 2021.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes 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 February 19, 2021, that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) fees rule to give stakeholders more time to review and comment.  The current comment period was set to close on February 25, 2021.  EPA is extending the comment period an additional 30 days.  Information on the proposed updates is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 18, 2021, that it is opening a public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  Upon publication of the Federal Register notice announcing the public comment period, EPA will accept public comments on the request for 45 days.  EPA states that it “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
     
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
     
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of amended TSCA including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  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).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine (National Academies) announced the availability of a report entitled The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations.  The U.S. Environmental Protection Agency (EPA) requested that the National Academies convene a committee to review EPA’s 2018 guidance document on Application of Systematic Review in TSCA Risk Evaluations and associated materials.  In its final report, the Committee to Review EPA’s Toxic Substances Control Act (TSCA) Systematic Review Guidance Document states that it “was in strong consensus that the processes used by [the Office of Pollution Prevention and Toxics (OPPT)] do not meet the evaluation criteria specified in the Statement of Task (i.e., comprehensive, workable, objective, and transparent).”  The Committee recognizes the “substantial challenges in implementing review methods on the schedule required by” the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), but concluded that those challenges “have not yet been successfully met.”  The final report includes the following summary of the Committee’s general recommendations:

  • OPPT’s approach to systematic review does not adequately meet the state of the practice.  The Committee suggests that OPPT comprehensively reevaluate its approach to systematic review methods, addressing the comments and recommendations provided in Chapter 2 of the final report.
     
  • With regard to hazard assessment for human and ecological receptors, the Committee comments that “OPPT should step back from the approach that it has taken and consider components” of the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program, EPA’s Integrated Risk Information System (IRIS), and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.
     
  • The Committee finds that OPPT’s use of systematic review for the evidence streams, for which systematic review has not been previously adapted, “to be particularly unsuccessful.”  The Committee suggests that OPPT elaborate plans for continuing the refinement of methods, ideally in collaboration with internal and external stakeholders.  The Committee also suggests that OPPT evaluate how the existing OHAT, IRIS, and Navigation Guide methods could be modified for the other evidence streams.  In addition, according to the Committee, OPPT should use existing EPA guidance, such as the Guidelines for Human Exposure Assessment, the Guidelines for Ecological Risk Assessment, and the operating procedures for the use of the ECOTOXicology knowledgebase (ECOTOX).  Following these existing guidelines would improve transparency of the assessments.
     
  • The Committee recommends that EPA put together a handbook for TSCA review and evidence integration methodology that details the steps in the process.  Throughout the final report, the Committee points to problems of documentation.  The Committee “believes that the effort of developing and publicly vetting a handbook will pay off in the long run by making the process more straightforward, transparent, and easier to follow.”

The final report states that “[t]here is an ongoing cross-sector effort to develop and validate new tools and approaches for exposure, environmental health, and other new areas of application of systematic review,” and the Committee “strongly recommends that OPPT staff engage in these efforts.”  According to the final report, the approaches used for TSCA evaluation “would benefit from the substantial external expertise available,” as well as additional transparency and acceptance by the different stakeholders as these tools are developed.
 
EPA published a press release on February 16, 2021, in response to the Committee’s report, announcing that it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” TSCA chemical risk evaluations.  According to EPA, its “ongoing effort to update its systematic review approach” is also part of its “broader efforts” to review the first ten TSCA risk evaluations.  EPA states that it “is not using, and will not again use, the systematic review approach that was reviewed by the Academies.”  The 2018 Application of Systematic Review document “represented EPA’s practices at that time.”  According to the press release, EPA has already begun to develop a TSCA systematic review protocol in collaboration with its Office of Research and Development to incorporate approaches from the IRIS Program.  EPA “expects to publish and take public comment on a TSCA systematic review protocol that will adopt many of the recommendations in the Academies’ report later this year.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published on February 8, 2021, a periodic update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim:

  • Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and
  • Review and make determinations on a representative subset of at least 25% of other CBI claims that are not exempt from substantiation and review.

The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020.  In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.
EPA states that making this information publicly available continues to demonstrate its commitment to transparency while fulfilling its responsibilities under TSCA.  EPA notes that 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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on February 3, 2021, “to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for Asbestos Part 1:  Chrysotile Asbestos.”  EPA states that the webinar will also give the public an opportunity to provide input on considerations the agency should take into account for managing these unreasonable risks.  Stakeholders who wish to provide oral comments must register by 5:00 p.m. (EST) on January 29, 2021, and those who will only listen may register up to the end of the meeting.  EPA will provide a transcript and recording on EPA’s Asbestos Part 1:  Chrysotile Asbestos web page following the webinar.  According to EPA’s January 19, 2021, announcement, EPA will begin formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  There will also be an open public comment period on any draft risk management regulation.  More information on EPA’s final risk evaluation is available in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for Asbestos, Part 1:  Chrysotile Asbestos.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation.  EPA states that after reviewing the available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation and dermal exposures for workers.  According to EPA, companies subject to the test orders may provide EPA with existing data or conduct new tests.  Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing.  The nine chemicals subject to the Section 4 test orders are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,1-Dichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

EPA states that the orders and any data submitted in response to the orders will be made publicly available on EPA’s website and in applicable dockets on www.regulations.gov.  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 January 11, 2021, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  86 Fed. Reg. 1890.  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary.  The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined.  The proposed updates include:

  • Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for research and development (R&D) purposes, and companies that produce a chemical as a non-isolated intermediate;
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
  • Adding three new fee categories, two associated with new chemicals activities and one with test orders.

Comments are due February 25, 2021.  More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold webinars on February 2, 2021, and February 18, 2021, to consult with environmental justice communities on risk management for the cyclic aliphatic bromide cluster (HBCD) and carbon tetrachloride.  The webinars will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals.  EPA states that both sessions will address HBCD and carbon tetrachloride.  EPA is offering repeated sessions to increase opportunities for participation.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from HBCD and carbon tetrachloride, and discussion of environmental justice concerns.  EPA notes that in addition to being open to the public, it 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 formal consultations with small businesses, state and local governments, and tribes.  There will also be an open public comment period on the proposed risk management regulations.  More information on EPA’s final risk evaluations is available in our September 28, 2020, memorandum, “EPA Publishes Final Risk Evaluation for HBCD,” and in our November 4, 2020, memorandum, “Final Risk Evaluation for Carbon Tetrachloride Finds Unreasonable Risks to Workers and Occupational Non-Users.”


 
 1 2 3 >  Last ›