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) 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 9, 2019, that in advance of the December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA).  Materials for the December 10, 2019, meeting include:

The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g).  The table contains information from CBI reviews including:

  • Case Number;
  • Submission Type;
  • CBI Review Category (specific chemical identity, other information, or both);
  • Final Determination;
  • Determination Rationale Summary;
  • For CBI Claims for Specific Chemical Identity:
  • EPA Unique Identifier (UID);
  • Accession Number;
  • Generic Name; and
  • Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.

EPA states that it plans to update this information on a quarterly basis.


 

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:


 

On November 13, 2019, Bergeson & Campbell, P.C. (B&C®), presented “Value Chain Communications Required under TSCA Consent Orders and SNURs:  How to Formulate Them and Optimize Their Value,” a complimentary webinar for our clients and friends.  Richard E. Engler, Ph.D., Director of Chemistry, B&C, outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules (SNUR).  Lynn L. Bergeson, Managing Partner, B&C, discussed the considerable value of formulating these communications with a view toward developing a consistent and positive product narrative that resonates far beyond Toxic Substances Control Act (TSCA) compliance.  A recording of this webinar is available now.


 

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) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program.  At the meeting, EPA will:

  • Provide an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA”;
  • Demonstrate how EPA has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples;
  • Provide an update on confidential business information (CBI) process improvements and clarifications; and
  • Discuss its progress on transparency in the TSCA New Chemicals program.

By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment.  EPA states that feedback from the public meeting and comments received will help inform its ongoing efforts to improve the way EPA reviews new chemicals under TSCA.  Details regarding the meeting are available in the prepublication version of the Federal Register notice announcing the meeting.

Background

EPA states in the prepublication version of the Federal Register notice that after considering comments received on the 2017 version of the “Working Approach” document and based on additional implementation experience, EPA is updating the “Working Approach” document.  Later in December 2019, EPA will announce the availability of the updated document after the public meeting and will hold a public comment period.  According to the notice, EPA expects the updated document to provide further clarity and detail on EPA’s approach and practices, including:  (1) EPA’s general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA Section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations allowable under the statute.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:

EPA notes that it is required to publish information pertaining to new chemical submissions under TSCA Section 5.  EPA states that historically, these data have been, and will continue to be, made available monthly in the Federal Register via www.regulations.gov.  According to EPA, the new web pages “are a much easier way for the public to access information about new chemical submissions.”  The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a confidential business information (CBI) claim).  EPA states that it will update the web pages monthly.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 12, 2019, announcing the availability of its response to a petition it received under Section 21 of the Toxic Substances Control Act (TSCA) from Public Employees for Environmental Responsibility (PEER).  84 Fed. Reg. 60986.  As reported in our August 23, 2019, blog item, PEER petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries under TSCA Section 6(a) and under the Administrative Procedure Act (APA) to take the same action pursuant to Section 112 of the Clean Air Act (CAA).  PEER petitioned EPA to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries and require a phase-out of use at such facilities within two years.  EPA states that after “careful consideration,” it has denied the Section 21 petition.  EPA notes that the Federal Register notice specifically addresses only the TSCA Section 21 petition, not the petition submitted under the APA.  EPA is denying the petition “based on the petition’s lack of sufficient facts establishing that it is necessary for the Agency to issue a rule under TSCA section 6(a).”  According to EPA, to grant a petition for a TSCA Section 6(a) rulemaking, a petition must provide facts establishing that the requested rulemaking is necessary.  Those facts need to be “sufficiently clear and robust for EPA to be able to conclude, within 90 days of filing the petition, that the chemical presents an unreasonable risk of injury to health or the environment and that issuance of a TSCA section 6(a) rule is the appropriate response to the petition.”  To make the threshold finding, EPA needs hazard and exposure data and other information to enable it to assess risk and conclude whether the risk is unreasonable.  In this case, EPA states that PEER’s petition “refers to hazard databases and makes conclusory statements of toxicity but provides little further information that would support granting a TSCA section 6(a) rulemaking request.”  According to EPA, the petition lacks the analysis that would be expected in a TSCA risk evaluation preceding a Section 6(a) rulemaking, such as “discussion of the appropriate hazard threshold, exposure estimates, assessment of risks, or how the facts presented allow EPA to comply with its duties under section 26 or other statutory requirements in making an unreasonable risk determination.”  Absent such information, EPA “cannot make the threshold determinations necessary to substantively assess and grant a petition for a TSCA section 6(a) rulemaking.”  EPA denies PEER’s petition request as facially incomplete.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants.
 
As reported in our September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020


 
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