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.”

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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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By Lynn L. Bergeson and Carla N. Hutton
 
The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including:

• Excluding from its analysis known human and environmental exposures to a chemical, based on the assumption that those exposures are adequately managed by other statutes;
   
• Claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of the Occupational Safety and Health Administration (OSHA) regulations that either do not apply or are out of date;
   
• Arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
   
• Choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, instead making “questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.”

EDF states that through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or find risks that are low enough that it can impose few restrictions.  According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community.  EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns.  According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.”  EDF states that “[t]his is beyond the pale” for the following reasons:

1. Such issues fall squarely within SACC’s charge.  EPA’s charge questions to SACC for its most recent peer review of 1-bromopropane (1-BP) “specifically (and appropriately) call on the SACC to comment on the ‘assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP’”;
    
2. It is “absolutely” SACC’s role and responsibility to comment on the scientific consequences of EPA’s decisions that directly affect its characterization of exposure, hazard, and risk; and
    
3. With respect to the adequacy of the information on which EPA relies, EPA “has recently made an additional claim to the SACC:  that EPA has no choice but to use the data it has readily at hand, however limited they are.”

EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary remand.”  As to the remainder of petitioners’ claims, EPA maintains that their allegations “are based on hypotheticals and other non-final agency actions currently being considered by the agency.”  EPA argues that the court should dismiss petitioners’ challenges to:  (1) EPA’s preamble statements about the potential scope of future risk evaluations; (2) EPA’s regulatory provisions leaving the door open to issue early risk determinations; and (3) the remaining information-gathering provisions still at issue.  EPA states that if it “ever takes final agency actions based on the decisions Petitioners hypothesize, those would be the proper actions for Petitioners’ challenges.”
 
A coalition of industry associations filed a supplemental brief in support of EPA on June 28, 2019.  The coalition states:  “Although it is theoretically possible that EPA could exclude a use of a particular chemical that could affect the risk evaluation in a way that could cause the agency not to regulate some use of a chemical that could injure Petitioners’ members, that does not create a justiciable controversy now, before the Rules have been applied.”  (Emphasis in original.)  The coalition asks the court to dismiss the petitions for lack of jurisdiction.
 
As reported in our June 26, 2019, blog item, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments on May 16, 2019, and afterward ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.

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By Lynn L. Bergeson and Margaret R. Graham

On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register:

• Procedures for Chemical Risk Evaluation; and
• Procedures for Prioritization of Chemicals for Risk Evaluation.

These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published.  EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations:

• Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations.

More information on these final rules and the guidance are available in our memorandum EPA Issues Final TSCA Framework Rules.  

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By Lynn L. Bergeson and Margaret R. Graham

On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA).  82 Fed. Reg. 31592.  The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider in conducting the risk evaluation.”  The direct links to the scope documents are available in our blog item EPA Issues Much Anticipated Three Final TSCA Framework Rules, Guidance on Draft Risk Evaluations, and Scoping Documents on Risk Evaluations of First Ten Chemicals under Revised TSCA.

The notice also reiterates that EPA is re-opening existing dockets for the first ten chemicals to “allow for the public to provide additional data or information that could be useful to the Agency in conducting problem formulation, the next step in the process of conducting the risk evaluations for these chemicals.”  More information on the reopening of the dockets for public comments, including links to the individual dockets, is available in our blog item EPA Opens Comment Period on Risk Evaluations for First Ten Chemicals under Revised TSCA.  As stated in the memo reopening the dockets, but curiously not stated in the published notice (no dates were included), comments are due September 19, 2017.

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