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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  EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA).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.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 4, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft risk evaluation for N-methylpyrrolidone (NMP), which includes more than 30 uses of NMP in adhesives, sealants, paints and arts and craft paints, paint and coating removers, adhesive removers, and degreasers.  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.

EPA notes that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not EPA’s final determinations on whether NMP presents unreasonable risks under the conditions of use.  EPA will publish a Federal Register notice announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  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 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.  More information will be available in our forthcoming memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2019, the U.S. Environmental Protection Agency published a Federal Register notice announcing the availability of the draft Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride (MC).  84 Fed. Reg. 57866.  As reported in our October 26, 2019, blog item, EPA is submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review.  SACC will convene an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed 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 by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Comments on the draft risk evaluation are due December 30, 2019.
 
The draft risk evaluation states that EPA’s initial determinations of unreasonable risk for the specific conditions of use of MC listed below are based on health risks to workers, occupational non-users (ONU), consumers, or bystanders from consumer use.  According to the draft risk evaluation, risks to the general population either were not relevant for these conditions of use or were evaluated and not found to be unreasonable.

  • Unreasonable Risk to Workers:  EPA determined that the conditions of use that presented unreasonable risks included processing MC into a formulation or mixture; all but two industrial and commercial uses; and disposal;
     
  • Unreasonable Risks to ONUs:  For ONUs, EPA determined that the conditions of use that presented unreasonable risks included import of MC, processing MC as a reactant in several industrial sectors, some industrial and commercial uses, and disposal.  EPA determined in some cases that a condition of use presented an unreasonable risk not only to workers but also to ONUs; in other cases, EPA determined that a condition of use presented an unreasonable risk only to one or the other.
     
  • Unreasonable Risk to Consumers:  EPA determined that all but two consumer conditions of use present unreasonable risks.
     
  • Unreasonable Risk to Bystanders (from Consumer Uses):  When EPA determined that a condition of use presented risks to consumers, unreasonable risks were often, but not always, identified for bystanders.

A more detailed summary of the draft risk evaluation and commentary will be available in our forthcoming memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC).  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will hold an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed 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 by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Publication of the Federal Register notice on October 29, 2019, will begin a 60-day comment period on the draft risk evaluation.  The draft risk evaluation is not yet publicly available and is not expected to be until the notice is published on October 29, 2019, and Docket ID EPA-HQ-OPPT-2019-0437 is created at http://www.regulations.gov.  More information is available in our October 25, 2019, memorandum, “EPA Will Publish Draft Risk Evaluation of Methylene Chloride on October 29.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
Alexandra Dapolito Dunn, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) stated on October 11, 2019, that EPA will provide more time for public comment on its draft risk evaluations before the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meets to peer review the draft documents.  According to Dunn, the new schedule will include a comment period of at least 30 days before SACC meets.  EPA plans to complete ten chemical risk evaluations by June 22, 2020.  To date, EPA has released four draft chemical risk evaluations, and SACC has peer reviewed them.  For the remaining six chemicals, EPA intends to release four of the draft risk evaluations for public comment by the end of 2019 and the other two in January 2020.  SACC will peer review two of the draft risk evaluations in 2019 and the remaining four in 2020.  Dunn stated that EPA will meet the Lautenberg Act’s deadline to release all ten risk evaluations by June 2020.


 
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