Draft Revision to Risk Determination for HBCD Retains Finding of Unreasonable Risk of Injury
On December 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 74082. 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.” Comments are due by February 14, 2022.
As reported in our July 1, 2021, memorandum, on June 30, 2021, EPA announced plans to revise specific aspects of the first ten risk evaluations issued under TSCA to ensure that the risk evaluations appropriately identify unreasonable risks and thereby help ensure the protection of human health and the environment. The policy changes include:
Whole Chemical Approach: Under the previous Administration, EPA made separate unreasonable risk determinations for every COU of a chemical. For the first ten chemicals evaluated under TSCA and for any similar chemical that presents significant risks across many uses, EPA will assess and analyze each COU but then make a determination of unreasonable risk just once for the whole chemical when it is clear the majority of the COUs warrant one determination; and
Use of PPE: In the final risk evaluations for the first ten chemicals, the previous Administration generally assumed that workers were always provided, and used, PPE appropriately. EPA states that data on violations of PPE use suggest that assumptions that PPE is always provided to workers, and worn properly, are not justified, however. EPA is therefore revisiting the assumption that PPE is always used in occupational settings when making risk determinations for a chemical. Instead, EPA plans to consider information on use of PPE, or other ways industry protects its workers, as a potential way to address unreasonable risk during the risk management process.
Draft Revision to the Risk Determination for the Risk Evaluation for HBCD
EPA developed the draft revision following a review of the first ten risk evaluations, and the draft revision reflects EPA’s announced policy changes. 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.” According to the Federal Register notice, the draft revision supersedes the COU-specific no unreasonable risk determinations in the September 2020 HBCD risk evaluation (and withdraws the associated order) and makes a revised determination of unreasonable risk for HBCD as a whole chemical substance. EPA states that the draft revised risk determination “does not reflect an assumption that workers always appropriately wear” PPE.
EPA states that it is specifically seeking public comment on the draft revision to the risk determination where EPA intends to determine if HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its COUs. According to EPA, this whole chemical approach to determining unreasonable risk to health is permissible under EPA’s statutory obligations under TSCA Section 6(b)(4) and the implementing regulations and would revise and replace Section 5 of the 2020 risk evaluation for HBCD where the findings of unreasonable risk to health and the environment were previously made for the individual COUs evaluated.
According to EPA, under the proposed changes, the same six COUs would continue to drive the unreasonable risk determination for HBCD. The impact of removing the assumption of PPE use by workers would cause four of the six COUs that drive the unreasonable risk determination based on only risks to the environment to also drive unreasonable risk based on health risks to workers, however. The four COUs affected by this proposed change are: Import; Processing: Incorporation into formulation, mixture, or reaction products; Processing: Incorporation into articles; and Processing: Recycling (of XPS and EPS foam, resin, panels containing HBCD). Six COUs would drive the HBCD whole chemical unreasonable risk determination due to risks identified for both the environment and health.
According to EPA, the revisions to the unreasonable risk determination (Section 5 of the risk evaluation) would be based on the existing risk characterization section of the risk evaluation (Section 4 of the risk evaluation) and would not involve additional technical or scientific analysis. EPA states that the discussion of the issues in the Federal Register notice and in the accompanying draft revision to the risk determination would supersede any conflicting statements in the prior HBCD risk evaluation and the response to comments document. With respect to the HBCD risk evaluation, EPA intends to change the risk determination to a whole chemical approach and does not intend to amend, nor does a whole chemical approach require amending, the underlying scientific analysis of the risk evaluation in the risk characterization section of the risk evaluation. EPA notes that it also views the peer-reviewed hazard and exposure assessments and associated risk characterization “as robust and upholding the standards of best available science and weight of the scientific evidence” pursuant to TSCA Sections 26(h) and (i).
EPA states that going forward, it intends to make its determination of unreasonable risk from a baseline scenario that does not assume compliance with Occupational Safety and Health Administration (OSHA) standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. According to EPA, making unreasonable risk determinations based on the baseline scenario “reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements.”
In accordance with this approach, EPA proposes that the draft revision to the HBCD risk determination not rely on assumptions regarding the occupational use of PPE in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA invites comments on this proposed change to the HBCD risk determination. EPA states that as a general matter, when undertaking risk management actions, it “intends to strive for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls, when those measures would address an unreasonable risk; ensure the EPA requirements apply to all potentially exposed workers; and develop occupational risk mitigation measures to address any unreasonable risks identified by EPA.”
EPA’s draft updates to this and the other first ten risk evaluations have been expected since the new Administration took over and announced that it would re-review all ten risk evaluations issued in final by the previous Administration. EPA’s announcement and the revised draft unreasonable risk determination for HBCD reiterate two of the key policy changes announced in 2021. First, EPA would make determinations on the “whole chemical” rather than individual COUs and that EPA would not assume that personal protective equipment (PPE) is always used. Today’s release is only a revised draft of the risk determination portion (Section 5) of the HBCD risk evaluation; it leaves unchanged the underlying facts and calculations. It remains to be seen how this will play out in terms of the legal effect of EPA’s risk evaluations. Presumably, once the updated risk determination is final, EPA will withdraw the order in which EPA found no unreasonable risk for some COUs for HBCD. Doing so will presumably moot the legal challenges to the final Agency action that have been voluntarily remanded for the limited purpose of permitting EPA to reconsider the challenged no-unreasonable-risk determinations. EPA has yet to propose risk management rules for any of the first ten chemicals, although the proposed asbestos risk management rule is under review in the Office of Management and Budget as of December 29, 2021.
The other key policy change is that EPA will no longer assume that PPE is “always used.” EPA does not explain how “always used” meets the definition of “reasonably foreseeable.” This policy may be more of a philosophical change than a practical one for the existing chemical risk evaluations and risk management. In the 2020 risk evaluation for HBCD, EPA evaluated worker exposures with and without glove and respiratory protection and found unreasonable risk for many unprotected exposures and some exposure scenarios with PPE use. It is not clear how EPA’s new policy will change the risk evaluation and risk management rules now that EPA is using a “whole chemical” approach. EPA retains its evaluation of protected COUs, including (without explanation) some assumptions about protective engineering controls. Perhaps the different approach will only be reflected in the risk management phase in which EPA will, presumably, promulgate regulations requiring a certain level of protection and/or establish an existing chemical exposure limit (ECEL). With the original risk evaluation and old PPE policy, EPA likely would have had to require some level of workplace protection in its risk management rule, since EPA found unreasonable risk in many unprotected exposure scenarios and some protected exposure scenarios.
In the revised risk determination, EPA explains that its determination of unreasonable risk “does not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE.” EPA further explains its view is based on a subpopulation of workers that are “not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements.” EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) appears simply to assume that OSHA no longer has any meaningful legal effect. It is not clear to us that this is supported by the legislative record in which Congress specifically stated that misuse was not within the definition of “reasonably foreseeable” for purposes of the COU. Perhaps OCSPP does not view non-compliance with OSHA standards as misuse. It is also difficult for us to understand why OCSPP appears to be of the view that a self-employed individual would take measures to protect him- or herself only if there is a TSCA regulation requiring such self-protection or that EPA would ever take enforcement action against such an individual for non-compliance. It is especially surprising that EPA goes to considerable effort to rationalize its assumptions about PPE when EPA already appeared to have the necessary factual predicate to impose workplace protection standards.
Relatedly, to the extent EPA discounts the effect of OSHA PPE requirements in making unreasonable risk determinations, it is difficult to understand why any TSCA risk management requirements addressing unreasonable risk should be treated differently. Would EPA assume non-compliance with existing TSCA regulations addressing worker exposure, for example, in any re-evaluation of a chemical substance?
Given EPA’s “new approach,” it is somewhat surprising that the COUs identified as presenting unreasonable risk to health are unchanged in Table 5-1 of both the original risk evaluation and the draft risk determination. The most significant change between the two versions (besides the new format) is that the COUs that were found to not present unreasonable risk are simply excluded from the updated Table 5-1 in the draft determination document. EPA did not alter its conclusion about the risks for those COUs; it just does not list those COUs in the table, presumably because the table has been renamed as “Supporting Bases for the Draft Revised Unreasonable Risk Determination for Human Health.” Previously the table was entitled “Detailed Unreasonable Risk Determinations by Condition of Use.” EPA also deleted the detailed discussion of the facts that underlie each of EPA’s conclusions, including, for example, the differentiation between workers and occupational non-users (ONU). One might rationalize this change as a result of EPA’s “whole chemical approach.” If that were the case, the conclusion could be summarized by a single statement because if EPA finds any COU to present an unreasonable risk (or the majority of COUs, as EPA stated in its June 30, 2021, announcement), the entire chemical is an unreasonable risk regardless of how many COUs might not present an unreasonable risk.
Finally, we note that the “whole chemical” approach to the TSCA risk determination appears at odds with EPA’s risk evaluation procedural rule. 40 C.F.R. Section 702.47 states, “As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents” (emphasis added). We expect EPA will address this conflict in its planned revision to the risk evaluation rule.