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

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.”  The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council.  According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chlorid[]e from their air and water.”

As reported in our June 25, 2020, memorandum, “Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments,” after evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under any conditions of use.  Release of a final risk evaluation is the last step in the Toxic Substances Control Act (TSCA) Section 6(b) process and will guide EPA’s efforts in applying Section 6(a) to reduce human exposure to methylene chloride “so that the chemical . . . no longer presents such risk.”  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 could prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of methylene chloride.  Any regulatory action will include opportunities for public comment.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes.  OIG states that EPA’s Safer Choice program does not have formal goals included in the fiscal year (FY) 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019.  The program does have internal, non-outcome-oriented goals, however, which it is generally achieving.  The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year.  According to OIG, in FY 2019, EPA added 265 products and 24 chemicals.  OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions.  OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP).  EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents.  Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits.  According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard.  OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.


 

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.”


 

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 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

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 32036.  The new due date is June 15, 2020.  EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations.  EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.

EPA held a conference call on TSCA fees on April 16, 2020, and posted the slides and transcript for the call.  EPA’s web page on TSCA fees for EPA-initiated risk evaluations includes frequently asked questions.  Our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia,” provides information on forming a consortium.  More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan).  Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has been initiated but not yet completed, and includes an updated schedule for completion of risk evaluations, if appropriate.  The Annual Plan states that in fiscal year (FY) 2020, EPA intends to complete final risk evaluations for the first ten chemicals.  As reported in our April 7 and April 20, 2020, blog items, EPA has published the draft scope documents for the risk evaluations to be conducted for the 20 high-priority substances designated in December 2019.  According to the Annual Plan, EPA expects to issue final draft scope documents in June 2020.  In accordance with statutory timelines, EPA states that it will publish final risk evaluations within three years of initiation, with a possible six-month extension.  In May 2019, EPA received manufacturer requests to conduct risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  EPA expects to release draft scope documents in the third quarter of FY 2020, complying with statutory timelines.  In March 2020, EPA received a facially complete manufacturer request to conduct a risk evaluation on octamethylcyclotetrasiloxane (D4).  EPA expects to ask for public comment on this request and make a final determination as to whether to grant this request within FY 2020.  EPA notes that it may receive additional requests in FY 2020 and will conduct the process to review these requests as directed in the Risk Evaluation Process Rule.  TSCA requires EPA to review fees and consider updating the fees rule every three years to ensure fees are adequate to defray 25 percent of the costs for implementing TSCA Sections 4, 5, 6, and 14, and to consult with stakeholders again if fees change.  In 2020, EPA expects to begin this process to review fees and propose certain exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that import the chemical substance in an article, produce the chemical substance as a byproduct, and produce or import the chemical substance as an impurity.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on the U.S. Environmental Protection Agency (EPA).  EPA Administrator Andrew Wheeler was the only witness.  During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under the amended Toxic Substances Control Act (TSCA), particularly the risk evaluation of asbestos.  Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for issuing final risk evaluations for the first ten chemicals.  According to Wheeler, EPA is spending more time on these first risk evaluations to make sure they get them right.  Wheeler noted that the peer reviews are taking longer than expected and that the interagency review process has taken longer than anticipated.  Wheeler stated that he thinks EPA is on track to have at least two of the first ten risk evaluations done by June 2020 and the remainder by the end of summer 2020.  Regarding the asbestos risk evaluation, EPA will do a separate supplemental risk evaluation on the legacy uses since EPA can likely complete the final risk evaluation of asbestos this summer.  Merkley asked Wheeler whether he would commit to examining all significant pathways of exposure to asbestos, including air, waste, and drinking water.  Wheeler responded that when a chemical under the TSCA review process is already being regulated under a different program, EPA decided early on that in setting out the parameters for the TSCA risk evaluations, it would not double regulate to focus its time on the areas of the chemicals that are unregulated at this point.  Wheeler states that the way to meet the strict deadlines required by TSCA is to allow the other programs that are already regulating aspects of those chemicals to continue to regulate them, whether it is a hazardous air pollutant under the air program or a regulation under the water program.


 
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