EPA Releases White Paper on Modernizing the Process and Bringing Innovative Science to Evaluating New Chemicals Under TSCA

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EPA recently released a white paper, The New Chemicals Collaborative Research Program: Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA. The document was produced as a summary report to the Board of Scientific Counselors as an integrative research plan under the 2023-2026 Chemical Safety for Sustainability (CSS) Strategic Research Action Plan. This plan seeks to address concerns by both industry and environmental organizations, including the significant lag in EPA’s review of new chemicals, lack of transparency in the process, and insufficient consideration of potential hazards. In addition, the plan would allow EPA’s staff to use new scientific methods to analyze chemical impacts on humans and the environment.

Under TSCA, chemical manufacturers have not been required to provide chemical hazard data in their PMN applications. Under the proposed new processes, data on toxicity, exposure, chemical use, and other databases, in conjunction with computer-based analysis methods, would make chemical reviews easier for the Agency. The plan will focus on five key research areas:

(1) Updates and refinements to chemical analog and category approach.

(2) Development and expansion of databases containing TSCA chemical information.

(3) Development and refinement of predictive models for physiochemical properties, environmental fate/transport, hazard, exposure, and toxicokinetics.

(4) Integration and application of in vitro New Approach Methodologies (NAMs).

(5) Development of a TSCA new chemicals decision support tool that utilizes curated data.

Using these NAMs, the Agency hopes to fill information gaps and address the challenges of its current framework.

EPA Launches Stakeholder Outreach Effort to Help Speed New Chemical Reviews

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On June 27, 2022, EPA announced its TSCA New Chemical Engineering Initiative.  EPA seeks to increase efficiency and transparency in the new chemical review process by inviting stakeholders to learn more about how the agency evaluates submitted information.  EPA plans to focus the initiative specifically on issues surrounding “engineering” information, including, but not limited to, occupational exposures and environmental releases.

The initiative has been launched in response to significant delays in new chemical reviews.  Frequently, submitters will provide additional information after the safety review process of a chemical under Section 5 of the Toxic Substances Control Act (TSCA) has already begun.  When EPA receives this additional information, it must revise its risk assessment (known as a “rework”) which causes delays in completing its review process and finalizing its risk assessment.  In an analysis of previous cases, EPA determined that an individual case may be reworked anywhere from one to five times, delaying the process at least several months.

EPA will be conducting a series of webinars providing an in-depth look at how the Agency analyzes submissions, including EPA’s written methodology of how its conducts analysis.  EPA intends to present case studies to stakeholders to further demonstrate what it considers acceptable in submissions.  Webinars will also communicate EPA’s considerations in evaluating qualitative claims or quantitative data, particularly in circumstances in which they deviate from model defaults such as those used in the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER).  Webinars will also discuss EPA’s considerations in evaluating information about sites that are not controlled by the submitter.

The kick-off meeting for the series was held on July 27, 2022.  The meeting detailed background on rework analysis, causes of reworks, examples of rework cases, and general observations.  EPA will be releasing information including the dates for two additional webinars in this fall.

OIG to Audit EPA New Chemicals Review

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EPA’s Office of Inspector General (OIG) has informed the Office of Chemical Safety and Pollution Prevention (OCSPP) that it will audit EPA’s process for conducting reviews of new TSCA chemicals (i.e., substances submitted to the Premanufacture Notification (PMN) and PMN exemption processes).  This is a self-initiated audit to accomplish OIG’s oversight plan for fiscal year 2022, to address ensuring safe use of chemicals, and to address complaints from the OIG Hotline.  OIG seeks to determine the extent EPA is following records-management requirements, quality-assurance requirements, and employee performance standards.  OIG will also be looking at how EPA manages human health and environmental risks for approving new chemicals under TSCA.

OIG has asked OCSPP to assist in expediting the audit by providing all materials, handbooks, and anything related to the review of new chemicals; the resource allocations for chemical review from fiscal years 2018 through 2021; scopes of work for any contracts related to chemical review; any guidance they have received on chemical review; and new chemicals review program organization charts before and after the October 2020 reorganization.

OIG notes authority under the Inspector General Act of 1078, as amended, to have timely access to their requests and personnel.  In addition to the Inspector General Act, in its request, OIG references EPA Manual 6500 and statements from Administrator Michael S. Regan.

EPA Proposes Non-Consent-Order SNURs for 13 Chemical Substances

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On October 16, 2018, the Environmental Protection Agency (EPA) issued a proposed rule that would establish Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances for which premanufacture notices (PMNs) have been approved during the two years since the statute was amended. A total of 6 SNURs were proposed for these 13 substances. Unlike other recent SNURs enacted after TSCA was amended, the 13 chemical substances are not also subject to consent orders. Indeed, all previously proposed and final SNURs for PMNs under amended TSCA were for substances for which EPA had previously negotiated orders under TSCA Section 5(e).

The proposed SNURs would require that persons who intend to manufacture (including import) or process any of the 13 chemical substances for an activity that is designated as a significant new use submit a “Significant New Use Notice” to EPA at least 90 days before commencing that activity. And, consistent with the SNUR regulations at 40 CFR § 721.25, the proposed rule states that persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice and decided on the notice, and the person has taken any actions as are required as a result of that determination. Comments on the proposed SNURs are due November 15, 2018.

EPA Publishes Direct Final Rules for 29 Significant New Use Rules

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On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. All 29 chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The rules require persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that new use.

The covered chemicals vary, but include several substances intended for use as coatings additives. The requirements for each of the substances differ, but may include limitations on the uses of the substance, hazard communication, personal protective equipment use, and the submission of certain toxicity testing data. Both direct final rules will be effective on October 26, 2018.

NRDC Petitions 2nd Circuit to Review EPA’s New Chemicals Decision-Making Framework

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On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a petition for review with the United States Court of Appeals for the Second Circuit, asking that the court review “a final rule of the U.S. Environmental Protection Agency (EPA) entitled New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  A stay was not filed with the petition.

On its website, NRDC asserts that it filed the petition to overturn the Agency’s “Framework” “because it is both unlawful under TSCA and was adopted without the minimum legal requirements for ‘rules.’”

The case is Natural Resources Defense Council v. U.S. Environmental Protection Agency, 2d Cir., No. 18-25

EPA to Hold Public Meeting on New Chemicals Review program

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EPA is holding two meetings in December to discuss ongoing implementation activities under the Frank R. Lautenberg Chemical Safety Act, which amended Toxic Substances Control Act (TSCA). On December 6, 2017, EPA is holding the first public meeting on new chemicals. The first meeting is to update and engage with the public on the Agency’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, including discussion of EPA’s New Chemicals Decision-Making Framework.

The meeting will be held December 6, 2017, 9:00 a.m. to 5:00 p.m. at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, DC 20004. EPA will describe its review process for new chemicals under the amended statute, and interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program since the statute was amended and to ask questions.

EPA will accept questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows. To register to attend, submit questions, and learn more follow this link.

EPA Announces Changes to the New Chemical Review Program

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In the wake of the 2016 amendment to the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has been focusing on streamlining new chemical review. On August 7, 2017, the Agency announced several related changes to the new chemical review process. Major reforms include:

  • Where a Premanufacture Notice (PMN) raises risk concerns, EPA will allow manufacturers to submit an amended PMN to address those concerns, and will base its judgment on the amended PMN.
  • Where EPA has concerns with product uses that can reasonably be foreseen but are not the intended uses described in the PMN, EPA’s concerns can be addressed through significant new use rules (SNURs).
  • Identification of reasonably foreseen conditions of use that are not addressed in a PMN will be fact-specific. EPA will find that a use is reasonably foreseeable where facts suggest that the use is not only possible but probable.
  • Section 5 testing orders will be confined to cases where they are necessary to reduce uncertainty in “unreasonable risk” findings, and will be structured to reduce or replace animal testing where appropriate.

EPA also announced that it will increase the full-time staff for new chemical review and will streamline related work processes. In addition, to help companies prepare PMNs, EPA will institute a voluntary pre-submission consultation process to provide submitters with a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process. Further support for submitters will be available this fall. EPA announced that it will publish for public comment draft guidance to provide more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations.

First new chemical determinations released by EPA under amended TSCA.

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Last Friday, the U.S. EPA issued its first regulatory determinations for new chemical substances under the newly amended Toxic Substances Control Act (TSCA). EPA published premanufacture notices (PMNs) for four new chemicals, concluding that all four were “not likely to present an unreasonable risk” to human health or the environment. The decision means that manufacturers and importers may make or import the chemicals, which will be used as lubricants, plastics additives, and in combination with other substances to make polymers.

For all four new chemicals, the agency found low potential for both human health and environmental hazards. Two of the chemicals were “very persistent,” but the agency found that neither presented an unreasonable risk due to “low potential for bioaccumulation,” as well as low health and environmental hazards.

These actions are the agency’s first under “TSCA 2.0,” after the Frank R. Lautenberg Chemical Safety for the 21st Century Act went into effect last month. As reported by Greenwire, the American Chemistry Council lauded the new chemical determinations as “an example of the new law already working.” The environmental advocacy nonprofit EDF praised the EPA’s openness while criticizing the agency on other issues, including the withholding of confidential business information (CBI), use of estimated data, providing only summaries of the determination documents, and “cursory consideration of exposure and exposed subpopulations.”

EPA proposes new SNUR for perfluorinated chemicals, again eliminates articles exemption.

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EPA has proposed another Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, including perfluorooctanoic acid (PFOA) and its salts. Under the proposal, significant new uses that would require filing a 90-day notice with EPA include: manufacturing, importing, or processing “an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemicals substances for which there are currently no ongoing uses.” In addition, EPA is continuing its trend in making the articles exemption inapplicable for these substances when imported as part of an article.

In the same proposed rule, EPA also proposes amending a SNUR for perfluorylalkyl sulfonate (PFAS) substances to make the articles exemption inapplicable for importing PFAS substances as part of carpets.

The affected chemicals are used in a variety of industrial applications and consumer goods, including cleaners, textiles, paper and paints, fire-fighting foams, and wire insulation. Their risks to human health and the environment include toxicity, persistence in the environment, and bioaccumulation in humans and animals. The chemicals are found in the blood of the general U.S. population and studies indicate that they may cause reproductive, developmental and systemic effects.

EPA’s proposal targets LCPFAC chemicals containing PFOA and its higher homologues, including the salts and precursors of these substances. Based on data from the 2012 Chemical Data Reporting (CDR) rule, the LCPFAC substances identified in the proposed SNUR are known to have current or recent ongoing uses. Noting that it is not the agency’s intention to regulate fluoropolymers in this rule, the proposed SNUR’s definition of the LCPFAC category includes a perfluorinated carbon chain length upper limit of 20. However, certain LCPFAC substances intentionally used in fluoropolymer formulation would be subject to reporting for the designated significant new uses.

The proposal defines PFAS substances to mean “a category of perfluorinated sulfonate chemical substances of any chain length.” For PFAS substances, EPA proposes modifying an existing SNUR for the chemical substances listed at 40 CFR 721.9582(a)(1).

The proposed rule is just the latest step in the agency’s ongoing work to regulate perfluorinated chemicals. The SNUR supports EPA’s 2010/2015 PFOA Stewardship Program, a voluntary initiative launched in 2006 with the major global manufacturers of LCPFAC substances. The Stewardship Program aims for a complete emissions and product content phaseout of these chemicals by 2015, and the most recent progress reports on the Program for the years 2014 and 2013, released last week, finds that the participating companies are on track to meet this goal. EPA notes that the SNUR for LCPFACs is proposed “in part in anticipation of this 2015 phase-out deadline.” In addition, the SNUR is consistent with EPA’s 2009 LCPFAC Action Plan. In October 2013, EPA finalized another SNUR on LCPFACs in carpets and PFAS, and earlier SNURs regulated PFAS and perfluorooctane sulfonate (PFOS).

Comments on the proposed rule will be accepted through March 23, 2015. In particular, EPA seeks to confirm through comments on this action whether use (including in articles) of the affected chemicals – or related ones – is still ongoing and will cease by the 2015 deadline. The agency notes that the proposed SNUR would not affect any ongoing uses of the chemicals except those that will be phased out by the end of 2015, although “uses not already ongoing as of the publication date of this proposed rule, and ongoing uses that will be phased out by the end of 2015, would not be considered ongoing uses if they later arise, even if they are in existence upon the issuance of a final rule. Furthermore, uses that are ongoing as of the publication date of this proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule (see Units IV. and VI. for further discussion of what constitutes an ongoing use).” EPA also requests comment on whether PFAS substances are currently imported as part of carpets.