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 January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing.  A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity.  Drs. Nicole Kleinstreuer and Kamel Mansouri will discuss the development of and demonstrate CATMoS, which was developed during a project in which the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the EPA National Center for Computational Toxicology (NCCT) collected a large body of rat oral acute toxicity data and made these data available to project participants.  Participants built several models that were then used to generate consensus predictions for the acute oral toxicity endpoints of interest to regulatory agencies.  The webinar will offer a walk-through of how to use the modeling suite to generate acute oral toxicity predictions for chemicals of interest.  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 December 20, 2019, the final list of high-priority chemicals.  These chemicals will be the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  According to EPA, issuing the final list of high-priority chemicals for risk evaluation “represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of existing chemicals in the marketplace.”  The 20 chemicals consist of seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer precursor:

  1. p-Dichlorobenzene;
  2. 1,2-Dichloroethane;
  3. trans-1,2- Dichloroethylene;
  4. o-Dichlorobenzene;
  5. 1,1,2-Trichloroethane;
  6. 1,2-Dichloropropane;
  7. 1,1-Dichloroethane;
  8. Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester);
  9. Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester;
  10. Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester);
  11. Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester);
  12. Dicyclohexyl phthalate;
  13. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA);
  14. Tris(2-chloroethyl) phosphate (TCEP);
  15. Phosphoric acid, triphenyl ester (TPP);
  16. Ethylene dibromide;
  17. 1,3-Butadiene;
  18. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
  19. Formaldehyde; and
  20. Phthalic anhydride.

More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 18, 2019, that it is extending the public comment period for the draft risk evaluation of N-methylpyrrolidone (NMP) to give stakeholders more time to review and comment on the draft document.  Comments are now due January 21, 2020.  EPA states that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals (SACC), to inform the final risk evaluation for NMP.  If the final risk evaluation for NMP finds there are unreasonable risks under any of the specific conditions of use, EPA will propose actions to address those risks within the timeframe required by the Toxic Substances Control Act (TSCA).  EPA notes that these actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical, as applicable.  EPA will publish a Federal Register notice announcing the comment period extension.  More information on the draft risk evaluation is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 13, 2019, that it contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations.  According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations.  EPA states that “[‌i]ntegrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.”  EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method.  NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020.  EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process.  EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host its first annual conference to discuss alternative test methods and strategies to reduce animal testing on December 17, 2019, in Washington, D.C.  According to EPA, the conference will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals.  The conference will focus on the New Approach Methods (NAM) and will feature presentations by U.S. and international scientific experts on advancements in the field.  On-site participants will have the opportunity to exchange information about scientific advancements in the NAMs field to develop a better understanding of the state of the science, discuss approaches for developing scientific confidence in using alternatives, and summarize existing studies characterizing the uncertainties in results from animal testing.  The public can register to participate via webinar.
 
As reported in our September 11, 2019, blog item, on September 10, 2019, EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing.  The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035.  Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.”
 
EPA notes that over the past several years, it has made significant scientific advancements in NAMs and has led efforts to reduce, replace, and refine its animal testing requirements.  On December 5, 2019, EPA updated the list of NAMs that it developed pursuant to the Toxic Substances Control Act (TSCA), as amended by the 2016 Lautenberg Chemical Safety Act.  EPA states that it “will continue to lead the way among federal agencies in the United States and internationally.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 2, 2019, that it granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA).  Manufacturer-requested risk evaluations are conducted in the same manner as other risk evaluations conducted under TSCA Section 6(b)(4)(A).  EPA received the manufacturer requests from ExxonMobil Chemical Company (for DIDP) and from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex (for DINP), both through the American Chemistry Council’s High Phthalates Panel.  Both chemicals were identified in the 2014 Update to the TSCA Work Plan.  As reported in our August 17, 2019, blog item, EPA held a public comment period on the requests, as well as additional conditions of use that EPA identified to include in the risk evaluations.  More information is available in our August 19, 2019, memorandum, “EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019.  Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for consumer use, including e-commerce sales.  EPA states that it “is encouraging all consumers to stop using methylene chloride products that they may have already purchased for paint and coating removal.”  EPA also reminds all retailers that sales of these products to consumers are prohibited by EPA regulations under the authority of Section 6 of the Toxic Substances Control Act (TSCA).  EPA promulgated the final regulation on methylene chloride for consumer paint and coating removal use on March 27, 2019, and the prohibition related to manufacturing, processing and distribution of methylene chloride for consumer paint and coating removal use is now in effect.  According to EPA, “[a] variety of effective, less harmful substitutes are readily available for paint removal.”  EPA notes that it “is continuing to work through the process outlined in TSCA to review the risks associated with other uses of methylene chloride.  This process is designed to thoroughly evaluate available science before taking action to manage the risk associated with the other uses of the chemical.”

More information on EPA’s actions concerning methylene chloride are available in the following memoranda:


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements.  Specifically, petitioners claimed that:  (1) TSCA requires EPA to evaluate risks associated with a chemical’s uses collectively before determining that the chemical is safe; (2) EPA must consider all of a chemical’s conditions of use in that evaluation; and (3) when considering conditions of use, EPA must evaluate past disposals of all chemicals, as well as the use and subsequent disposal of chemicals not currently or prospectively manufactured or distributed in commerce for that use.  Petitioners maintained that various provisions of the risk evaluation rule demonstrate that EPA will not do any of these three things.  The court held that it lacks jurisdiction to review petitioners’ first challenge, and that their second challenge fails on the merits.  The court granted in part the petition for review with respect to petitioners’ third challenge to EPA’s exclusion of “legacy uses” and “associated disposals” from the definition of “conditions of use,” and those portions of the risk evaluation rule’s preamble are vacated.  The court notes that because petitioners’ challenges to EPA’s prioritization rule are “entirely encompassed” within their challenges to the risk evaluation rule, the challenges rise or fall together.  The court thus focused only on the risk evaluation rule.
 
More information on the case is available in the following blog items:


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 7, 2019, announcing the availability of the draft risk evaluation for N-methylpyrrolidone (NMP) and soliciting public comment.  84 Fed. Reg. 60087.  EPA’s draft risk evaluation findings include:

  • EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment, bystanders, or occupational non-users from NMP.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use.  EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use.

The draft risk evaluation will be peer reviewed by the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on December 5-6, 2019.  EPA will hold a preparatory virtual meeting on November 12, 2019.  Stakeholders must register online on or before November 12, 2019, to receive the webcast meeting link and audio teleconference information.  Written comments for the preparatory virtual meeting and requests for time to present oral comments are due on or before 10:00 a.m. (EST) on November 12, 2019.  EPA requests comments on the draft risk evaluation by November 26, 2019, to allow SACC time to review and consider them before the peer review meeting.  EPA states that it will use feedback received from the public comment and peer review processes to inform the final risk determinations.  Comments on the draft risk evaluation are due January 6, 2020.  More information is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science?  The Future of Science in EPA Rulemaking.”  The Committee will hear from the following witnesses:
 
Panel 1

  • Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor.

Panel 2

  • Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-2019;
     
  • Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard Medical School; Pulmonary and Critical Care Physician, Beth Israel Deaconess Medical Center;
     
  • Dr. David Allison, Dean, School of Public Health, Indiana University-Bloomington; Member, “Reproducibility and Replicability in Science” Committee, The National Academies of Sciences, Engineering, and Medicine; and
     
  • Dr. Todd Sherer, Chief Executive Officer (CEO), The Michael J. Fox Foundation for Parkinson’s Research.

 
 1 2 3 >  Last ›