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 April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS).  EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS.  According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.”  EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff -- these were all issues with a version of the assessment that was posted during the previous administration.  The release of today’s PFBS assessment upholds the integrity of EPA’s science, which EPA, states, tribes, and more rely on to make decisions that protect the health of their communities.”
 
According to EPA’s fact sheet on the toxicity assessment, PFBS is a replacement chemical for perfluorooctanesulfonic acid (PFOS), a PFAS that was voluntarily phased out by the primary U.S. manufacturer by 2002.  PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.  The fact sheet states that the PFBS toxicity assessment is comparable to assessments developed under EPA’s Integrated Risk Information System (IRIS) and Provisional Peer-Reviewed Toxicity Value (PPRTV) Programs in that it provides hazard identification, dose-response information, and toxicity values.  EPA will continue to work with state, tribal, and local partners to provide technical assistance as they consider the final PFBS toxicity values in relevant exposure scenarios.  The fact sheet notes that at this time, EPA does not plan to issue a regulation for PFBS.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the 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.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA), “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  EPA “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 the amended [TSCA] including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

Comments were due April 5, 2021, but EPA is extending the comment period an additional 30 days.  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
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on February 18, 2021, “to educate stakeholders on proposed revisions to the Toxic Substances Control Act (TSCA) Fees Rule announced in December 2020.”  The webinar will also provide stakeholders an opportunity to provide comment to EPA on the proposed changes.  Stakeholders who would like to provide oral comments during the webinar must register by 5:00 p.m. (EST) on February 16, 2021.  Stakeholders may register as listen-only attendees at any time up to the end of the meeting.  EPA will provide details on how to access the webinar and slides after participants register via Eventbrite.com.  EPA states that it will provide a transcript and recording on the TSCA Administration Fees website following the webinar.  Comments on the proposed revisions to the rule are due February 25, 2021.  EPA intends to issue the final rule in 2021.  More information on the proposed rule 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 3, 2021, the latest update to the Toxic Substances Control Act (TSCA) Inventory, “a list of all existing chemical substances manufactured, processed, or imported” in the United States.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  EPA plans to release the next regular update of the Inventory in summer 2021.  According to EPA, the Inventory contains 86,557 chemicals of which 41,864 are active in U.S commerce.  EPA notes that other updates to the TSCA Inventory include new chemical substance additions, commercial activity data, and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR).


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 4, 2021, the ad hoc committee appointed by the National Academies of Sciences, Engineering, and Medicine (the National Academies) to consider current evidence regarding human health effects of the most widely studied per- and polyfluoroalkyl substances (PFAS) will hold its first meeting.  The National Academies will provide the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Institutes of Environmental Health Sciences (NIEHS) “an objective and authoritative review of current evidence regarding human health effects of those PFAS being monitored in the CDC’s National Report on Human Exposure to Environmental Chemicals.”  The National Academies will also provide recommendations regarding potential changes to CDC and ATSDR PFAS clinical guidance, including:

  • Options and considerations to guide decision-making for PFAS testing in a patient’s blood or urine;
  • PFAS concentrations that could inform clinical care of exposed patients; and
  • Appropriate patient follow-up and care specific to PFAS-associated health endpoints for those patients known or suspected to be exposed to PFAS.

The committee will host multiple town hall events in the spring and summer 2021 to hear from PFAS-impacted communities.  The National Academies intends to release the final report in 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 22, 2021, the U.S. Environmental Protection Agency (EPA) published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS).  86 Fed. Reg. 6602.  The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) to fund and carry out this testing under the direction of a panel of independent scientists.  EPA states that it finds the petitioners have not provided the facts necessary for it to determine for each of the 54 PFAS that “existing information and experience are insufficient and testing of such substance or mixture with respect to such effects is necessary to develop such information.”  After “careful consideration,” EPA denied the TSCA petition for the following reasons:

  • Insufficient Information and Experience:  According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” for each of the 54 PFAS.  The petitioners state, in part, “[f]or the 54 PFAS, the sufficiency of available information should be determined by comparing available data with the known adverse effects of other PFAS.  The goal should be to conduct a scientifically sound assessment of each of the 54 chemicals for the critical toxic endpoints that have been identified in studies on [perfluorooctane sulfonate (PFOS)], [perfluorooctanoic acid (PFOA)] and other well-characterized studies.”  EPA states that the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience, however;
     
  • Testing of Such Substance or Mixture with Respect to Such Effects Is Necessary to Develop Such Information:  According to EPA, the petitioners do not demonstrate “testing of such substance or mixture with respect to such effects is necessary to develop such information.”  EPA finds that the petitioners failed to address ongoing testing and data collections for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish there is a need for the testing sought in the petition.  According to EPA, this research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA Section 4(a)(1)(A)(i)(III);
     
  • Class-Based Approach to Testing:  TSCA Section 4(h)(1)(B)(ii) “encourage[s]” EPA to consider “the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category.”  EPA states that it “is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities.”  EPA notes that it collaborated with the National Toxicology Program (NTP) “to construct a PFAS screening library subset composed of 75 PFAS on a structural category basis and considerations such as structural diversity within a category, data availability, and read-across category-level weight (e.g., value of substance for anchoring read-across trends within a category, serving as an analog); four of the 54 PFAS the petitioners identify are included in this subset.”  While the petitioners mention this effort, they “incorrectly state that just two of the 54 PFAS the petitioners cover are included in the EPA testing.”
     
  • Practicability of National Academy of Sciences Oversight:  The petitioners also request that the National Academy of Sciences (NAS) oversee all aspects of the proposed testing program.  EPA states that it “finds such an oversight arrangement is not within the scope of what a TSCA section 21 petitioner can request when seeking the initiation of a rule or the issuance of an order under TSCA section 4.”  Furthermore, according to EPA, projects and studies must meet certain conditions for the NAS to accept private funding.  EPA concludes that it is not in a position to require NAS to oversee the testing requested by the petitioners, and the petitioners provide no administrative or organizational procedures for implementation.
     
  • Selection of PFAS for Health and Environmental Effects Testing:  The petitioners divide the 54 PFAS at issue into Tier 1 substances “for which there is known human exposure based on detection in blood, food or drinking water,” and Tier 2 substances “for which human exposure is probable based on detection in environmental media.”  According to EPA, the petitioners do not set forth facts showing that for all 40 PFAS it ranks as Tier 2 substances “human exposure is probable based on detection in environmental media” or that “a strong inference of exposure can be drawn from their presence in surface water, stormwater, wastewater, sediment, groundwater, soil, private wells, and/or air emissions,” however.
     
  • Scientific Standards:  EPA states that it “finds the petitioners have not evaluated the quality of the data they have provided or indicated how they conducted their searches, evaluated the quality of the sources, or indicated what gaps were located and then explained why the specific tests requested, as compared to others, would provide the data being sought.”  According to EPA, such an evaluation is necessary for EPA to conduct the considerations under TSCA Section 26(h).
     
  • Vertebrate Testing:  TSCA Section 4(h) requires that EPA reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA Section 4.  EPA states that it must consider “as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including (i) Toxicity information; (ii) Computational toxicology and bioinformatics; and (iii) High-throughput screening methods and the prediction models of those methods.”

More information on the TSCA Section 21 petition is available in our October 29, 2020, memorandum, “TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS.”


 

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 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 September 30, 2020, the U.S. Environmental Protection Agency (EPA) will hold a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List:  A Proposed NAM Nomination Form.”  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended Section 4(h)(2)(c) of the Toxic Substances Control Act (TSCA) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.”  The current TSCA Section 4(h)(2)(C) List is available on the EPA website.  EPA’s 2018 Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program provides initial criteria for considering scientific reliability and relevance of new approach methodologies (NAM) to be eligible for placement on the List.  EPA states that it “envisions that any party interested in proposing a NAM for placement on the List would use a nomination form.”  The webinar will walk through the proposed nomination form.
 
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) International Science Consortium, EPA, and the Physicians for Responsible Medicine (PCRM).  EPA notes that it does not necessarily endorse the views of the speakers.


 

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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