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By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA).  According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective public communication in developing risk mitigation requirements for companies following EPA completion of a Risk Evaluation under TSCA.”  ACA states that a procedural rule “is needed to establish a central point of reference for all requirements and considerations involved in crafting a risk management rule regulating a specific chemical.”  The petitioners ask EPA to implement an updated risk management procedural rule addressing considerations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).  According to the press release, the petition lists and describes various risk mitigation considerations under the Lautenberg Act’s framework that should be addressed in a procedural rule, including considerations related to transparency, deadlines for compliance, notice, effective dates, exemptions for critical or essential use, coordination with and/or delegation to other agencies, and processes to amend a risk mitigation rule.  ACA states that EPA has 90 days from filing to grant or deny the petition.  If EPA grants the petition, EPA can enter into a public rulemaking process, as requested by petitioners, though it is not required to do so.  ACA notes that while the Administrative Procedure Act (APA) provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements, “petitioners believe that EPA should publish the requested section 6 risk management procedural rule for notice and comment because the information and opinions supplied by the public will inform the Agency’s views.”


 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with EPA Assistant Administrator Alexandra Dunn.  As many of our listeners know, Alex Dunn heads the Office of Chemical Safety and Pollution Prevention and is responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively.

Alex has an extensive background in the environmental field and is a leading voice on TSCA and FIFRA.  Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of States.  She has published extensively in the areas of the ethics of community advocacy, environmental justice, urban sustainability, water quality, cooperative federalism, the Clean Water Act, and more.

Given Alex’s high profile role at EPA, we focused our discussion on implementation of the amendments to TSCA, which Congress enacted in 2016.  As we record this session, we are at the four-year anniversary of the new law, and we celebrate EPA’s many accomplishments in implementing the Congressionally mandated changes to the law.  As pollution prevention is an integral part of EPA’s mission, we also focus on initiatives under way to introduce safer and greener chemicals.  Finally, our discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2020 Bergeson & Campbell, P.C.  All Rights Reserve


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 24, 2020, announcing the availability of the final Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride.  85 Fed. Reg. 37942.  This is the first risk evaluation that EPA has completed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA.  After evaluating 53 conditions of use of methylene chloride, EPA determined that six conditions of use do not present an unreasonable risk of injury to health, while 47 present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under the conditions of use.  In its June 19, 2020, press release, EPA notes that the next step in the process required by TSCA is addressing the identified risks.  According to EPA, there are several actions it could take to address these risks, including regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical substance, as applicable.  EPA will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.  EPA states that as with any chemical product, it “strongly recommends that users continue to carefully follow all instructions on the product’s label/safety data sheet.”  As reported in our November 22, 2019, blog item, EPA’s March 27, 2019, final regulation prohibited the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use after November 22, 2019.  More information on the final risk evaluation for methylene chloride will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

During the week of June 15, 2020, the U.S. District Court for the Northern District of California heard from the U.S. Environmental Protection Agency’s (EPA) final three witnesses:  Dr. Joyce Tsuji, Dr. Ellen Chang, and Dr. Tala Henry.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  Dr. Tsuji did not dispute that fluoride can be a neurotoxin at “high enough levels.”  Dr. Tsuji contended that the scientific literature remains too limited to establish linkage between fluoride and adverse health outcomes.  Dr. Chang testified on the application of systematic review to chemical usage, a process EPA explored at length with its first witness, Dr. Kris Thayer, as reported in our June 12, 2020, blog item.

Dr. Henry defended the EPA Office of Pollution Prevention and Toxics’ (OPPT) decision to deny plaintiffs’ Section 21 petition.  As Director of EPA's Risk Assessment Division, Dr. Henry expressed the view that “robust science” warranted rejection of the petition.  On June 17, 2020, plaintiffs called back Dr. Kathleen Thiessen as a rebuttal witness, who testified briefly in response to the criticism by EPA’s witnesses of plaintiffs’ methodology in studies mentioned earlier in the trial. After Dr. Thiessen’s testimony, the trial moved to closing arguments.

Plaintiffs’ closing argument asserted that EPA failed to quantify what fluoride levels were dangerous to humans.  District Judge Edward M. Chen interceded to inquire in this regard as tests showing neurotoxicity were well above the level in fluoridation chemicals introduced into water.  Plaintiffs argued the necessity of taking into account inter-species differences from animal testing, as well as human-to-human differences.  Plaintiffs stated that this lack of data seriously hinders determining at what level susceptibility can be found.

EPA responded in its closing that studies relied on by plaintiffs are limited by confounding variables, lack of comparison groups, and double-blind methodologies.  Additionally, EPA noted inconsistencies among the reports plaintiffs cited.  Judge Chen followed up with questions regarding the counter-intuitive findings of effects from fluoride exposure in adult rats but not infants and wanted to confirm if this was a byproduct of the quality of research.  EPA replied that there is insufficient evidence to defend an IQ-urine connection.  Judge Chen also asked if the court could find unreasonable risk from the chemical used by EPA without causation of neurological effects. EPA responded that the only standard provided in the Toxic Substances Control Act (TSCA) regarding unreasonable risk is that which results from an evaluation of that risk, not causation.

After hearing closing arguments, Judge Chen noted that the evidence presented by both parties was not confined to the administrative record and that he allowed both parties to use evidence that was available after plaintiffs filed their petition in 2016 Judge Chen asked plaintiffs and EPA to consider how to reach an agreement, including plaintiffs submitting a new petition or EPA reconsidering its denial of the petition.  Pending Judge Chen's request for additional briefing, there was no ruling on what could potentially be the first half of a bifurcated trial.  A status conference is tentatively scheduled for August 6, 2020, at 10:30 a.m. (PDT).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Consumer Product Safety Commission (CPSC) will hold a public webinar on July 1, 2020, to receive information from interested parties about changes to CPSC’s Publicly Available Consumer Product Safety Information Database, www.SaferProducts.gov, that are in development to improve the website’s usefulness and navigability.  CPSC states in its June 18, 2020, Federal Register notice that based, in part, on input from a March 2019 public hearing, CPSC is holding the webinar to show the changes to the website that are in development.  85 Fed. Reg. 36838.  According to CPSC, these changes seek to improve usability and navigability on the website; make the website more mobile friendly with other devices, including smartphones and tablets; and improve cross-browser compatibility.  Participants who register for the webinar will have an opportunity to see these changes and provide feedback to CPSC through a moderated discussion.  All attendees should pre-register for the webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On June 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2020 Green Chemistry Challenge Awards.  EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.”  The 2020 winners and their innovative technologies are:

  • Genomatica, San Diego, California, for creating Brontide™, a new brand of 1,3-butylene glycol, commonly used in cosmetics for moisture retention and as a carrier for plant extracts.  Butylene glycol is traditionally produced from fossil fuels.  Brontide™ is produced by fermenting E. coli using renewable sugars in a one-step production process, however.  This method reduces greenhouse gas emissions and avoids the use of hazardous chemicals in the production process.
     
  • Merck, Rahway, New Jersey, for improving the process used to produce certain antiviral drugs used for the treatment of diseases including hepatitis C and HIV.  According to EPA, the new process improved manufacturing efficiency and sustainability of one important antiviral by more than 85 percent.  This method reduces waste and hazards associated with the existing process and results in substantial cost savings.
  • Johns Manville, Littleton, Colorado, for developing a biobased, formaldehyde-free thermoset binder for fiberglass reinforcement applications.  Thermoset binders are used to bind glass fibers of fiberglass mats used in carpet tile backing.  EPA states that this technology eliminates the use of hazardous chemicals, reduces water and energy use, and produces a product with a longer shelf life.
     
  • Professor Steven Skerlos, University of Michigan and Fusion Coolant Systems, for creating Pure-Cut™, an alternative to traditional metalworking fluids that uses high-pressure carbon dioxide instead of oil-based lubricants.  According to EPA, Pure-Cut™ can improve performance and machining tool life span compared to traditional metalworking fluids, while greatly reducing hazards to the environment and worker health.
     
  • Vestaron, Kalamazoo, Michigan, for producing a new biopesticide called Spear®.  This pesticide is based on a naturally occurring component inspired by spider venom that can effectively control target pests while showing no adverse effects on people, the environment, and non-target wildlife, such as fish and bees.  EPA notes that Spear® should provide growers with a new pest management tool that also lessens environmental impacts.

EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year.  EPA and the American Chemical Society co-sponsor the awards.  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners.


 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

As we are now into June, Toxic Substances Control Act (TSCA) aficionados will be quick to note that “new TSCA” is now almost four years old.  Passage in June 2016 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act occasioned EPA’s implementation of a law that has transformed industrial chemical regulation in the United States.  This week, to mark Lautenberg’s fourth birthday, I sat down with Dr. Richard E. Engler, B&C’s Director of Chemistry and all-around expert on all things TSCA, to look back on what EPA stakeholders have achieved over the past four years, and to look forward to what to expect the remainder of this year and beyond.  We address the progress EPA has made in reviewing new chemical innovations, regulating existing industrial chemicals, what early challenges have been resolved, and a few of the frustrations that linger.  As a 17-year veteran of EPA’s Office of Pollution Prevention and Toxics and now an extremely busy and tops in his field private consultant, Rich knows TSCA from both sides, and his insights are always spot on.

Rich is a Ph.D. chemist who focuses here at B&C and our consulting affiliate, The Acta Group (Acta®), on all aspects of TSCA regulation and science policy.  In addition to his duties as a top chemist at EPA, Rich also headed EPA’s Green Chemistry Program.  Rich has reviewed more than 10,000 chemical notifications under TSCA and now is an indispensable part of our deep TSCA bench here at B&C and Acta.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 12, 2020, that it is opening a public comment period for a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  EPA states that the manufacturer-requested risk evaluation of D4 is the third evaluation of this kind to be requested under the amended Toxic Substances Control Act (TSCA).  EPA will publish a notice in the Federal Register announcing the public comment period and beginning a 45-day comment period.  EPA “welcomes all public comments on this request, particularly on the following”:

  • Any information not included in the manufacturer request that the commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use the Agency 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 is proposing to include in the risk evaluation.

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.  EPA has opened Docket ID EPA-HQ-OPPT-2018-0443 for the request.


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

The U.S. District Court for the Northern District of California began hearing oral arguments on June 8, 2020, in a case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  The plaintiffs filed suit following the U.S. Environmental Protection Agency’s (EPA) denial of a TSCA Section 21 petition requesting it to exercise its Section 6 authority to prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.  On June 12, 2020, Dr. Kathleen M. Thiessen testified as the final witness for the plaintiffs’ case-in-chief regarding risk analysis to determine a level of fluoride that does not produce adverse effects.  Thiessen also testified about a study that found correlation between fluoride intake and diminished thyroid productivity.  EPA’s first witness, Dr. Kristina Thayer, clarified the types of experimental biases and processes to vet bodies of evidence.  Earlier in the week, plaintiffs’ expert witnesses summarized the scientific literature on the adverse effects of fluoride on children’s development, including lowered IQ.  The experts have cited both animal and human studies.  EPA has questioned them at length regarding the discrepancies between male and female test subjects, especially in relation to prenatal fluoride exposure.  EPA has argued that the data presented by plaintiffs suffers from inconsistencies, flawed methodologies, and biases.  The trial will resume on Monday, June 15, 2020.  Readers interested in watching the trial remotely can find scheduling and Zoom information here.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances.  On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  85 Fed. Reg. 12479.  Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.  As noted in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” one of the goals of the proposed supplemental SNUR is to establish the ground rules for EPA’s consideration of the article exemption in future SNUR actions.  The final SNUR that is under OMB review is not publicly available, so it remains to be seen whether EPA has successfully established policies and procedures that both align with statutory requirements and also are workable, effective, predictable, transparent, and justified scientifically.


 
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