Draft Revision to Risk Determination for HBCD Retains Finding of Unreasonable Risk of Injury

On December 29, 2021, the U.S. Environmental Safety Company (EPA) introduced the supply of a draft revision to the danger willpower for the cyclic aliphatic bromide cluster (HBCD) threat analysis issued below the Poisonous Substances Management Act (TSCA). 86 Fed. Reg. 74082. EPA is reconsidering two key points of the danger determinations for HBCD. First, EPA proposes that the suitable strategy to these determinations below TSCA and implementing rules is to make an unreasonable threat willpower for HBCD as an entire chemical substance, moderately than making unreasonable threat determinations individually on every particular person situation of use (COU) evaluated within the threat analysis. Second, EPA proposes that the danger willpower needs to be specific that it doesn’t depend on assumptions concerning the use of private protecting gear (PPE) in making the unreasonable threat willpower below TSCA Part 6; moderately, the use of PPE could be thought of throughout threat administration. 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.” Feedback are due by February 14, 2022.

Background

As reported in our July 1, 2021, memorandum, on June 30, 2021, EPA announced plans to revise particular points of the primary ten threat evaluations issued below TSCA to be sure that the danger evaluations appropriately determine unreasonable dangers and thereby assist make sure the safety of human well being and the atmosphere. The coverage modifications embody:

  • Entire Chemical Method: Below the earlier Administration, EPA made separate unreasonable threat determinations for each COU of a chemical. For the primary ten chemical substances evaluated below TSCA and for any comparable chemical that presents important dangers throughout many makes use of, EPA will assess and analyze every COU however then make a willpower of unreasonable threat simply as soon as for the entire chemical when it’s clear the bulk of the COUs warrant one willpower; and

  • Use of PPE: Within the last threat evaluations for the primary ten chemical substances, the earlier Administration typically assumed that employees have been at all times offered, and used, PPE appropriately. EPA states that knowledge on violations of PPE use counsel that assumptions that PPE is at all times offered to employees, and worn correctly, should not justified, nevertheless. EPA is subsequently revisiting the idea that PPE is at all times utilized in occupational settings when making threat determinations for a chemical. As a substitute, EPA plans to think about info on use of PPE, or different methods trade protects its employees, as a possible means to deal with unreasonable threat in the course of the threat administration course of.

Draft Revision to the Risk Determination for the Risk Analysis for HBCD

EPA developed the draft revision following a assessment of the primary ten threat evaluations, and the draft revision displays EPA’s introduced coverage modifications. 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.” In accordance to the Federal Register discover, the draft revision supersedes the COU-specific no unreasonable threat determinations within the September 2020 HBCD threat analysis (and withdraws the related order) and makes a revised willpower of unreasonable threat for HBCD as an entire chemical substance. EPA states that the draft revised threat willpower “does not reflect an assumption that workers always appropriately wear” PPE.

EPA states that it’s particularly searching for public touch upon the draft revision to the danger willpower the place EPA intends to decide if HBCD, as an entire chemical substance, presents an unreasonable threat of damage to well being and the atmosphere when evaluated below its COUs. In accordance to EPA, this complete chemical strategy to figuring out unreasonable threat to well being is permissible below EPA’s statutory obligations below TSCA Part 6(b)(4) and the implementing rules and would revise and substitute Part 5 of the 2020 threat analysis for HBCD the place the findings of unreasonable threat to well being and the atmosphere have been beforehand made for the person COUs evaluated.

In accordance to EPA, below the proposed modifications, the identical six COUs would proceed to drive the unreasonable threat willpower for HBCD. The impression of eradicating the idea of PPE use by employees would trigger 4 of the six COUs that drive the unreasonable threat willpower primarily based on solely dangers to the atmosphere to additionally drive unreasonable threat primarily based on well being dangers to employees, nevertheless. The 4 COUs affected by this proposed change are: Import; Processing: Incorporation into formulation, combination, or response merchandise; Processing: Incorporation into articles; and Processing: Recycling (of XPS and EPS foam, resin, panels containing HBCD). Six COUs would drive the HBCD complete chemical unreasonable threat willpower due to dangers recognized for each the atmosphere and well being.

In accordance to EPA, the revisions to the unreasonable threat willpower (Part 5 of the danger analysis) could be primarily based on the present threat characterization part of the danger analysis (Part 4 of the danger analysis) and wouldn’t contain extra technical or scientific evaluation. EPA states that the dialogue of the problems within the Federal Register discover and within the accompanying draft revision to the danger willpower would supersede any conflicting statements within the prior HBCD threat analysis and the response to feedback doc. With respect to the HBCD threat analysis, EPA intends to change the danger willpower to an entire chemical strategy and doesn’t intend to amend, nor does an entire chemical strategy require amending, the underlying scientific evaluation of the danger analysis within the threat characterization part of the danger analysis. EPA notes that it additionally views the peer-reviewed hazard and publicity assessments and related threat 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 ahead, it intends to make its willpower of unreasonable threat from a baseline state of affairs that doesn’t assume compliance with Occupational Security and Well being Administration (OSHA) requirements, together with any relevant publicity limits or necessities for use of respiratory safety or different PPE. In accordance to EPA, making unreasonable threat determinations primarily based on the baseline state of affairs “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 strategy, EPA proposes that the draft revision to the HBCD threat willpower not depend on assumptions concerning the occupational use of PPE in making the unreasonable threat willpower below TSCA Part 6; moderately, the use of PPE could be thought of throughout threat administration. EPA invitations feedback on this proposed change to the HBCD threat willpower. EPA states that as a normal matter, when enterprise threat administration 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.”

Commentary

EPA’s draft updates to this and the opposite first ten threat evaluations have been anticipated for the reason that new Administration took over and introduced that it could re-review all ten threat evaluations issued in last by the earlier Administration. EPA’s announcement and the revised draft unreasonable threat willpower for HBCD reiterate two of the important thing coverage modifications introduced in 2021. First, EPA would make determinations on the “whole chemical” moderately than particular person COUs and that EPA wouldn’t assume that private protecting gear (PPE) is at all times used. At present’s launch is just a revised draft of the danger willpower portion (Part 5) of the HBCD threat analysis; it leaves unchanged the underlying info and calculations. It stays to be seen how this may play out in phrases of the authorized impact of EPA’s threat evaluations. Presumably, as soon as the up to date threat willpower is last, EPA will withdraw the order by which EPA discovered no unreasonable threat for some COUs for HBCD. Doing so will presumably moot the authorized challenges to the ultimate Company motion which have been voluntarily remanded for the restricted function of allowing EPA to rethink the challenged no-unreasonable-risk determinations. EPA has but to suggest threat administration guidelines for any of the primary ten chemical substances, though the proposed asbestos threat administration rule is below review within the Workplace of Administration and Price range as of December 29, 2021.

The opposite key coverage change is that EPA will now not assume that PPE is “always used.” EPA doesn’t clarify how “always used” meets the definition of “reasonably foreseeable.” This coverage could also be extra of a philosophical change than a sensible one for the present chemical threat evaluations and threat administration. Within the 2020 threat analysis for HBCD, EPA evaluated employee exposures with and with out glove and respiratory safety and located unreasonable threat for many unprotected exposures and a few publicity eventualities with PPE use. It isn’t clear how EPA’s new coverage will change the danger analysis and threat administration guidelines now that EPA is utilizing a “whole chemical” strategy. EPA retains its analysis of protected COUs, together with (with out rationalization) some assumptions about protecting engineering controls. Maybe the totally different strategy will solely be mirrored within the threat administration part by which EPA will, presumably, promulgate rules requiring a sure stage of safety and/or set up an current chemical publicity restrict (ECEL). With the unique threat analysis and previous PPE coverage, EPA possible would have had to require some stage of office safety in its threat administration rule, since EPA discovered unreasonable threat in lots of unprotected publicity eventualities and a few protected publicity eventualities.

Within the revised threat willpower, EPA explains that its willpower of unreasonable threat “does not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE.” EPA additional explains its view is predicated on a subpopulation of employees which can be “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 Workplace of Chemical Security and Air pollution Prevention (OCSPP) seems merely to assume that OSHA now not has any significant authorized impact. It isn’t clear to us that that is supported by the legislative document by which Congress specifically stated that misuse was not throughout the definition of “reasonably foreseeable” for functions of the COU. Maybe OCSPP doesn’t view non-compliance with OSHA requirements as misuse. Additionally it is tough for us to perceive why OCSPP seems to be of the view {that a} self-employed particular person would take measures to defend him- or herself provided that there’s a TSCA regulation requiring such self-protection or that EPA would ever take enforcement motion towards such a person for non-compliance. It’s particularly stunning that EPA goes to appreciable effort to rationalize its assumptions about PPE when EPA already appeared to have the required factual predicate to impose office safety requirements.

Relatedly, to the extent EPA reductions the impact of OSHA PPE necessities in making unreasonable threat determinations, it’s tough to perceive why any TSCA threat administration necessities addressing unreasonable threat needs to be handled in another way. Would EPA assume non-compliance with current TSCA rules addressing employee publicity, for instance, in any re-evaluation of a chemical substance?

Given EPA’s “new approach,” it’s considerably stunning that the COUs recognized as presenting unreasonable threat to well being are unchanged in Desk 5-1 of each the unique threat analysis and the draft threat willpower. Essentially the most important change between the 2 variations (moreover the brand new format) is that the COUs that have been discovered to not current unreasonable threat are merely excluded from the up to date Desk 5-1 within the draft willpower doc. EPA didn’t alter its conclusion concerning the dangers for these COUs; it simply doesn’t record these COUs within the desk, presumably as a result of the desk has been renamed as “Supporting Bases for the Draft Revised Unreasonable Risk Determination for Human Health.” Beforehand the desk was entitled “Detailed Unreasonable Risk Determinations by Condition of Use.” EPA additionally deleted the detailed dialogue of the info that underlie every of EPA’s conclusions, together with, for instance, the differentiation between employees and occupational non-users (ONU). One may rationalize this transformation because of this of EPA’s “whole chemical approach.” If that have been the case, the conclusion may very well be summarized by a single assertion as a result of if EPA finds any COU to current an unreasonable threat (or the bulk of COUs, as EPA said in its June 30, 2021, announcement), the whole chemical is an unreasonable threat regardless of what number of COUs won’t current an unreasonable threat.

Lastly, we observe that the “whole chemical” strategy to the TSCA threat willpower seems at odds with EPA’s threat analysis procedural rule. 40 C.F.R. Part 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 anticipate EPA will deal with this battle in its planned revision to the danger analysis rule.

Source link