Science advisors urge EPA to complete 1-BP risk assessment.

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The Chemical Safety Advisory Committee is urging the Environmental Protection Agency (EPA) to complete and publish its risk assessment of 1-bromopropane without delay, due to “the high risks of adverse effects” in occupational and consumer use scenarios that have already been evaluated. In meeting minutes [PDF] submitted to EPA last week, some Committee members commented that these risks might have been under-estimated. The chemical, also known as 1-BP, is used in spray adhesives, dry cleaning, and degreasing, and was among the chemicals identified in the 2012 Toxic Substances Control Act (TSCA) Work Plan.

The Committee, an independent panel of scientific advisors comprised of experts in toxicology, environmental risk assessment, exposure assessment and related fields, met in May to review the scientific and technical merit of EPA’s draft risk assessment for 1-BP, which was released in March 2016.

Overall, the Committee praised the draft risk assessment, concluding that “the conceptual model appropriately considers worker exposures and consumer uses, with the majority of exposure occurring via inhalation.” The Committee stressed the importance of including consumer uses with acute exposures, and several members called for better consideration of exposure from co-residence and community-level exposures near dry-cleaning facilities. The Committee provided recommendations “intended to improve the clarity and transparency of the scientific analyses,” including the adoption of systematic review processes to clarify how studies were selected and evaluated. Other recommendations include ways to refine occupational and consumer exposure assessments.

Under the new requirements of the Lautenberg Act, EPA must identify 10 Work Plan chemicals for risk evaluations to be initiated by December 2016. EPA will revamp the prioritization process for risk evaluations in 2017 and 2018, using new criteria to be established, through rule-making, by mid-June 2017.

EPA proposes updates to SNUR regulations on workplace protection and hazard communication.

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On July 28, EPA published a proposed rule updating the Significant New Use Rule (SNUR) regulations, which implement section 5(a)(2) of the Toxic Substances Control Act (TSCA). In announcing the proposal, EPA emphasized the need to harmonize regulations based on Occupational Safety and Health Administration (OSHA) standards for respiratory protection and hazard communication, which have both been updated since the SNUR regulations were last revised in 1989.

The proposed rule also contains several other changes meant to address “issues identified through EPA’s experience issuing and administering SNURs,” including changes to the bona fide intent to manufacture procedure. Additional, minor changes include correcting typographical errors, updating “material safety data sheet” or “MSDS” to “safety data sheet” or “SDS,” and revising language to “more accurately use the terms manufacture, manufacturer, and manufacturing.”

Notably, many of the proposed changes to the SNUR regulations will affect previously-issued SNURs.

EPA notes that, due to regulatory updates from both the National Institute for Occupational Safety and Health (NIOSH) and OSHA, the current regulatory language for protection in the workplace, concerning respiratory protection, is inconsistent with NIOSH and OSHA requirements. Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of NIOSH-certified respirators to the list of approved respirators. According to the proposed rule, companies subject to previously-issued SNURs containing respirator requirements can either follow the updated requirements or continue using the older respirators, if they are still available, without triggering a Significant New Use Notification (SNUN) requirement.

EPA also proposes to modify a subsection on airborne forms of chemicals by adding “particulate or aerosol,” “gas/vapor,” and combinations thereof.

The proposed rule further revises the workplace protection section by inserting the requirement that a hierarchy of controls – such as enclosure of operations, ventilation, and workplace policies and procedures – must be “considered and implemented to prevent exposure, where feasible” before using personal protective equipment (PPE) for worker protection. This change is reportedly in response to previous comments criticizing “EPA’s approach of exclusively identifying the absence of adequate personal protective equipment as a significant new use” as out of step with best practices in industrial hygiene. EPA notes that the new language has been incorporated in all new chemical SNURs issued since June 26, 2013 and is consistent with OSHA requirements.

The agency’s proposed updates on hazard communication are based on OSHA’s updates to its Hazard Communication Standard (HCS), which was itself modified, in 2012, to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). EPA also proposes adding a new requirement which could be used in new SNURs for a written hazard communication program in each workplace in accordance with the OSHA HCS. Another proposed addition provides specific statements and warnings that could be required under a SNUR and “would be based on EPA’s risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.”

In addition to the changes to the workplace protection and hazard communication revisions, EPA proposes various other modifications, including:

  • Bona fide procedure: Currently, when EPA issues a SNUR in which the chemical identity is withheld as confidential business information (CBI), manufacturers and processors may submit information to EPA to “determine whether their substance is subject to the SNUR.” EPA now proposes to amend the process to apply to other kinds of CBI, such as production volume limits, so EPA may inform bona fide submitters whether and how the SNUR applies to them, including any confidential significant new use designations.
  • Notice submission requirements: EPA proposes that notification submissions such as premanufacture notifications or low volume exemptions, among others, must include any SDS that has already been developed for the relevant chemical.

EPA has specifically requested comments on the following issues:

  • the use of “next generation” respirators;
  • the incorporation of the hierarchy of controls approach to worker protection in the SNUR requirements; and
  • “any suggested methods for minimizing respondent burden, including revisions to the automated collection techniques being used for submissions to EPA under TSCA, …the Agency’s Central Data Exchange (CDX) portal.”

The deadline for comments on the proposed rule is September 26, 2016.