By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 14, 2022, that it will reopen the comment period for its draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). As reported in our December 29, 2021, memorandum, EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable risk determination for HBCD as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use (COU) evaluated in the risk evaluation. Second, EPA proposes that the risk determination should be explicit that it does not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA “finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” EPA will publish a Federal Register notice on February 17, 2022, to reopen the comment period for 15 days. Comments will be due March 3, 2022.

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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives.  EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures.  EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.  According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.”  Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future.  EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means.  According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS).  Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable.  This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5.  In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order.  EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk.  It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain.  EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise.  The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process.  A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.”  Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision.  If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data.  In Bergeson & Campbell, P.C.’s (B&C^®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development.  B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting.  A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector.  The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so.  Today’s unexplained reversal is difficult to reconcile with these facts.  If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016.  As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.

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By Lynn L. Bergeson and Margaret R. Graham

On December 18, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting in part respondent U.S. Environmental Protection Agency’s (EPA) motion for partial voluntary remand of certain provisions of its final rule on Procedures for Chemicals Risk Evaluation under the Toxic Substances Control Act (TSCA).  Specifically, EPA’s motion for partial voluntary remand, filed August 6, 2018, sought remand with vacatur of 40 C.F.R. Section 702.31(d) (Penalty Provision) and remand without vacatur of 40 C.F.R. Sections 702.37(b)(4) (Relevancy Provision) and 702.37(b)(6) (Consistency Provision).  The Ninth Circuit granted EPA’s motion to remand and to vacate the Penalty Provision, but referred EPA’s motion to remand without vacatur for the Relevancy and Consistency Provisions.  The Penalty Provision states that “[s]ubmission to EPA of inaccurate, incomplete, or misleading information pursuant to a risk evaluation … is a prohibited act … subject to penalties.”

EPA stated in its motion that its “request to remand the Penalty, Relevancy, and Consistency provisions is reasonable, timely, and will serve the interests of judicial economy,” but it has not yet decided on a specific course of action.  EPA sought remand to address the potential concerns that petitioners stated in their opening brief.  EPA stated that vacatur was only appropriate for the Penalty Provision, however, as “nothing in the proposed rule or rulemaking record gave any indication that EPA was contemplating extending the Penalty Provision beyond manufacturers, and EPA did not purport to make that change in response to public comments, the Penalty Provision is not a logical outgrowth of the proposed rule.” 

As for the Relevancy and Consistency Provisions, EPA stated that they should be remanded but not vacated for the following reasons:

1. EPA believes that the concerns about these provisions can be addressed through modifications to the language of the regulations;
2. The unintended consequences of the Relevancy and Consistency Provisions that Petitioners allege are not serious; even if a manufacturer were to rely on those provisions to withhold information, EPA has independent authority to collect that information or require development of new information as needed to conduct its risk evaluations; and
3. The disruptive effects to EPA could be considerable if these regulations were vacated while EPA completes its remand process; if the provisions are vacated, manufacturers could (intentionally or unintentionally) submit junk science or irrelevant material, requiring EPA to consume limited resources and take time out of the statutorily-mandated schedule to review the information.  Further, vacatur of the Relevancy Provision would be particularly disruptive because it would eliminate altogether the affirmative requirement for manufacturers to submit lists of information when requesting risk evaluations; and could delay EPA’s information gathering if it had to request or order such information from the outset.

More information on the appeals to the TSCA framework rule on risk evaluation is available on our blog.

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