EPA releases updated PFBS toxicity agreement

2021-04-14

The U.S. Environmental Protection Agency (EPA) announced on April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS). EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS. According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.” EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff — these were all issues with a version of the assessment that was posted during the previous administration. The release of today’s PFBS assessment upholds the integrity of EPA’s science, which EPA, states, tribes, and more rely on to make decisions that protect the health of their communities.”

According to EPA’s fact sheet on the toxicity assessment, PFBS is a replacement chemical for perfluorooctanesulfonic acid (PFOS), a PFAS that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax. The fact sheet states that the PFBS toxicity assessment is comparable to assessments developed under EPA’s Integrated Risk Information System (IRIS) and Provisional Peer-Reviewed Toxicity Value (PPRTV) Programs in that it provides hazard identification, dose-response information, and toxicity values. EPA will continue to work with state, tribal, and local partners to provide technical assistance as they consider the final PFBS toxicity values in relevant exposure scenarios. The fact sheet notes that at this time, EPA does not plan to issue a regulation for PFBS.

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On April, 12, 2021, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice to extend the comment period of the notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS) by one month. The HCS is the federal-level legislation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed changes include updating the HCS to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed is one year for chemical manufacturers, importers, and distributors of substances and two years for chemical manufacturers, importers, and distributors of mixtures after the effective final rule is published. The notice was open for comments until April 19, 2021. OSHA states in the Federal Register that it will extend the comment period to May 19, 2021, and that it intends to schedule an informal public hearing.

Background

In 2012, the first update to the HCS since 1994 was published in the Federal Register. 77 Fed. Reg. 17574. The notice revised and amended the previous HCS substantially as it introduced the GHS concepts into the regulatory framework. At the time of publication, HCS 2012 was based on Rev 3 of GHS. The UN updates and revises the GHS model on a biannual basis, and at this time, the most current version is Rev 8. OSHA is proposing an update to align with Rev 7 and includes several other points of clarification and revision in the notice.

Overview of Proposed Amendments

Highlights of several major changes include the following:

Revisions to align with Rev 7, with consideration of specific elements of Rev 8;

Changes to labeling, including new label elements and accommodations to address small containers and bulk shipments;

Revisions, clarifications, and additions to definitions;

Updates to testing methods for various endpoints;

Considerations for concentrations ranges for Trade Secrets;

Proposed revisions to SDS content; and

Proposal for scheduled updates to the HCS.

For a more detailed discussion on a few of the more significant changes, see our February 16, 2021, memorandum, “OSHA Proposes Amendments to the Hazard Communication Standard.”

Issues for Comment

OSHA included an “Issues and Options Considered” section that is intended to solicit stakeholder input on various regulatory issues and to allow for potential regulatory flexibility with respect to the content of the final rule. While OSHA invites stakeholders to comment on all aspects of the NPRM, this section identifies the specific areas of interest. The section includes certain issues and questions that are intended to assist stakeholders as they review the proposal and consider the comments they plan to submit. Details on these issues were previously provided in our February 16, 2021, memorandum.

Commentary

Apparently, several parties requested an extension to the comment period. OSHA in the Federal Register states that it “agrees to an extension and believes a 30-day extension of the public comment period is sufficient and appropriate.” Stakeholders should note that the content provided in responses to the NPRM are public and should provide OSHA with sufficient detail to allow thoughtful consideration to any proposed changes to the current language in the NPRM.

OSHA includes in the proposed update several items related to labeling. These items are currently addressed in various Letters of Interpretation. OSHA is amending the HCS to include these items and seeks comments from stakeholders on this approach. Chemical manufacturers, importers, and distributors should review the changes and prepare comments to OSHA on the applicability and utility of these changes in their operations. The changes to allow concentration ranges as an approach for addressing trade secrets and to include prescribed proposed ranges create better alignment with Canada and allow additional options to those wishing to disclose certain details, while allowing exact concentrations to remain protected. The use of concentration ranges and proposed ranges is a benefit interested parties should consider supporting in comments to OSHA.

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TSCA Blog, 9 April 2021
; http://www.tscablog.com/entry/epa-releases-updated-pfbs-toxicity-assessment
; National Law Review, 14 April 2021
; https://www.natlawreview.com/article/osha-proposes-extension-to-comment-period-amendments-to-hazard-communication