EPA Announces Update of TSCA New Use Rules


The Environmental Protection Agency recently released an emailed press release on its evaluation surrounding the policies, guidances, templates and regulations under the Toxic Substances Control Act.

The Agency says 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.”

The announcement states that the EPA will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.

“Rather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA’s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks,” the Agency noted.

EPA intends to continue issuing SNURs following TSCA section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufacturers or processes the chemical in the future.

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.

Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.

TSCA Review Background

In February, the EPA eceived 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 Academic 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 previously to this announcement.

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 is 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 to 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’s 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 persistent, bioaccumulative and toxic (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 was just finalized last month and went into effect March 8.


Tagged categories: Environmental Protection Agency (EPA); Good Technical Practice; Government; NA; North America; Regulations

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