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EPA Plans New Rulemaking on PBT Chemicals

Thursday, September 9, 2021

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Last week, the Environmental Protection Agency announced its intentions to establish a new rulemaking process, and anticipates proposing new rules for five persistent, bioaccumulative and toxic (PBT) chemicals that are the subject to final risk management rules under the Toxic Substances Control Act (TSCA).

The rules are slated to address the exposure of toxic chemicals that remain in the environment for long periods of time and build up in the body. Additionally, EPA is taking action to extend the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirement of one of the PBT chemicals: phenol, isopropylated phosphate.

TSCA Review Background

In February, the EPA received a report evaluating its Toxic Substances Control Act chemical risk evaluations system, prompting the agency to announce that it will be refining its approach to selecting and reviewing the scientific studies that are used to inform its evaluations.

The peer review was contracted with the National Academies of Science, Engineering and Medicine in December 2019. The National Academies are private, nonprofit institutions that “provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine.”

The EPA also noted that this review is being done in accordance with directives from the Biden administration, which it acknowledged previous to this announcement.

© iStock / Skyhobo

Last week, the Environmental Protection Agency announced its intentions to establish a new rulemaking process, and anticipates proposing new rules for five persistent, bioaccumulative and toxic (PBT) chemicals that are the subject of final risk management rules under the Toxic Substances Control Act (TSCA).

The Academies specifically reviewed the EPA’s “2018 Application of Systematic Review in TSCA Risk Evaluations,” and its biggest critique was on the statutory schedule the EPA follows to complete assessments, which it says does not meet state-of-practice standards. The Academies suggested:

  • Staff should engage in ongoing cross-sector efforts to develop and validate new tools and approaches for exposure, environmental health and other areas where systematic review is applied. TSCA evaluation approaches would benefit from the substantial external expertise available as well as acceptance from outside stakeholders as the approaches are developed.
  • The decision to develop a wholly original approach to hazard assessment, rather than starting with other extant protocols as a foundation, is one source of the process’s problems. The EPA should consider incorporating components of methodologies from the National Institute of Environmental Health Science’s Office of Health Assessment and Translation and EPA’s Integrated Risk Information System and Navigation Guide.
  • Documentation of the process is incomplete and hard to follow. Staff should assemble a handbook for TSCA review and evidence integration methodology to detail steps in the process.
  • The terms “weight of evidence” and “systematic review” are used interchangeably. The report urges EPA to use standard descriptors for the strength of evidence instead.

“High quality, best available scientific data and studies are the foundation of our chemical risk evaluations,” said Michal Freedhoff, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “Strengthening the process used to select this information will improve chemical safety and ensure our risk evaluations protect human health and the environment.”

The EPA noted that it is no longer using the 2018 application and has already begun to review protocol. There is currently no timetable in place for the completion of that review.

Earlier in February, the EPA sent two emailed press releases discussing both a review of its actions of the course of the previous administration, as well as announcing educational webinars that focus on the recent risk evaluations of both pigment violet 29 (PV29) and n-methylpyrrolidone (NMP).

In the general chemical safety action update, the Agency said that it is reviewing all actions taken under the previous administration and that “this review is being done in accordance with the Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review.”

The EPA listed three rulings in particular that it will be reviewing, two of which fall under the Toxic Substances Control Act. The first is the expedited action on certain PBT chemicals, and the final rules that were associated with those actions that went into effect on Feb. 5.

“EPA is aware of concerns about these rules, including implementation issues, that have been raised by a range of stakeholders and may consider additional measures, approaches or revisions that build upon the steps taken thus far,” the EPA said at the time. “The agency is committed to working with all stakeholders to ensure these rules are both protective and practical.”

The EPA is also looking at the risk evaluations for the first 10 chemicals that were introduced under the revamped TSCA. It said that current risk management and stakeholder activities will continue while the process is being reviewed.

Finally, the EPA listed the Dust Lead Post-Abatement Clearance Level Final Rule, which went into effect March 8.

By the end of March, the EPA released an emailed press release on its evaluation surrounding the policies, guidelines, templates and regulations under the Toxic Substances Control Act.

The Agency said that it has identified several instances “where the approach for making determinations and managing risks associated with new chemicals can more closely align with the requirements of TSCA to ensure protections for human health and the environment, including the use of significant new use rules (SNURs) and assumptions related to worker exposures.”

In addition, though, EPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. When the EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment and hazard communication, it will no longer assume that workers are adequately protected under OSHA’s worker protection standards and updated Safety Data Sheets.

Rulemaking & Compliance Date Extensions

The TSCA has recently directed the EPA to take expedited action on certain PBT chemicals to reduce exposure and protect human health and the environment. Consistent with that mandate, final risk management rules restricting the use of five PBT chemicals were issued under the previous Administration in January 2021 and went into effect in February 2021.

Upon further review, the EPA is considering revising all five of the final rules to further reduce exposures, promote environmental justice, and better protect human health and the environment, and plans to issue a proposal for a new separate rulemaking on all five PBT chemicals in the spring of 2023.

The EPA reports that current provisions of the January 2021 risk management rules will remain in effect while the new rulemaking is in progress.

As a result of these changes, the EPA has also announced that it will be extending certain compliance dates for PIP (3:1) to March 8, 2022. In addition, the EPA plans to issue a notice of proposed rulemaking seeking comment on a further extension of the compliance date for PIP (3:1) articles to align with certain comments received and the expected timing for the new rulemaking on PBT chemicals previously mentioned.

The EPA will be accepting public comments in docket EPA-HQ-OPPT-2021-0598 on for 60 days from publication of that proposed rule.

As part of the separate rulemaking on all five PBT chemicals planned for 2023, EPA intends to reevaluate the current rules for PIP (3:1) and the other PBTs, as well as provide a description of the specific kinds of information the Agency will require to support any additional extensions to the compliance dates.

The EPA adds that final rules will be effective upon publication.


Tagged categories: Construction chemicals; Environmental Protection; Environmental Protection Agency (EPA); EPA; Good Technical Practice; Government; Health & Safety; Health and safety; NA; North America; Regulations

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