EPA’s Significant New Use Rules under TSCA must reflect its policy goals

Lauren Ellis, Research Analyst, Environmental Health 

We recently submitted comments to the Environmental Protection Agency (EPA) on a subset of proposed Significant New Use Rules (SNURs) published by the New Chemicals program under the Toxic Substances Control Act (TSCA). We commend EPA for issuing these proposed SNURs. Our review of some of the SNURs, however, raised concerns about chemical releases to the environment, risks to consumers, and the absence of worker protections. We believe EPA can address many of these concerns by following through on its stated policy goals. 

For all the chemicals in this batch, EPA had previously issued “consent orders” – which impose restrictions on a new chemical – because the agency found at the time of their initial review for market entry that the chemical substances may present an unreasonable risk to health or the environment. We strongly support EPA’s use of SNURs to follow up on consent orders it issues, as a consent order only applies to the original company that submitted a premanufacture notice (PMN) to EPA to domestically manufacture or import a new chemical. 

A SNUR is a separate action that requires any company seeking to engage in a “significant new use” identified in the SNUR to notify EPA at least 90 days before beginning that use, triggering EPA’s review of the potential new use. For new chemicals that received orders, a SNUR can conform to the order – meaning it mirrors the conditions in the consent order for the chemical – or it can apply more broadly to activities or uses that are beyond the scope of the consent order. Either way, SNURs enable the agency to review potentially risky uses prior to their commencement. 

In our comments, we call for four major changes to a subset of the proposed SNURs: 

Stop treating PFAS like it’s 2009

EPA has committed to taking an agency-wide approach to address per- and polyfluoroalkyl substances (PFAS), a group of highly persistent substances known as “forever chemicals.” Unfortunately, the proposed SNUR for two PFAS in this batch reflects how EPA viewed PFAS in 2009 when the consent orders were issued, rather than how the agency has pledged to approach PFAS today. 

In its proposed PFAS SNUR, EPA only designates release of the substances to water as a significant new use, which was the only prohibition in the 2009 consent order. Thus, the proposed SNUR conforms to the outdated consent order, and does not take into account EPA’s own 2017 re-evaluation of the consent order and the risks and recommendations it identified. 

The proposed SNUR is also inconsistent with EPA’s recently published PFAS Strategic Roadmap, where the Office of Chemical Safety and Pollution Prevention (OCSPP) stated that it is “looking at PFAS that it has previously reviewed through the TSCA New Chemicals program” and “plans to revisit past PFAS regulatory decisions and address those that are insufficiently protective.”

Based on the agency’s most recent findings and commitments, EPA should designate as significant new uses any use that leads to releases to the environment (air and land, in addition to water), any applications of these chemicals other than use as a chemical intermediate, and any use lacking worker protections and hazard communication where there is the potential for exposure – thus giving the agency the chance to review such uses, and limit them if warranted, before they begin.  

Require notification for uses resulting in environmental releases of PBTs 

EPA also proposed SNURs for 13 chemical substances used in photolithography that EPA indicated may be persistent, bioaccumulative, and toxic (PBT). The agency recognizes in its PBTs Policy Statement that PBTs present a heightened risk to the environment and human health due to their ability to build up in the environment, animals, and humans. In addition, for these particular substances, EPA identified health effects that included liver toxicity, neurotoxicity, and reproductive toxicity. EPA stated they were unable to assess the risks to surrounding communities or the environment due to insufficient information.  

Given the PBT nature of the chemicals and EPA’s uncertainty about their risks, EPA should have prohibited any activity resulting in the release of these PBTs to the environment in its consent orders for these substances, but did not. EPA should issue a final SNUR that extends beyond the terms of the consent order and designate as a significant new use any use resulting in a release of the chemicals to the environment.  

Ensure adequate worker protection and hazard communication 

Several of the proposed SNURs in this batch failed to adequately consider risks to workers, as TSCA’s language explicitly requires. For these chemicals, EPA should designate as a significant new use any activity or use that lacks worker protection and hazard communication. 

EPA announced in March 2021 that it changed its Trump-era new chemical review approach regarding worker protection, and no longer assumes that – in the absence of a regulatory requirement – employers will provide and require the use of protective equipment to mitigate risks to workers. 

We commend EPA for its stated change and appreciate the agency’s actions regarding worker protections in its recently revised HBCD risk determination. However, these new proposed SNURs do not include worker protections as significant new uses, and thus appear to continue the previous administration’s practice of assuming that employers will require protective equipment. 

TSCA requires that EPA explicitly consider “potentially exposed or susceptible subpopulations,” which includes workers, when evaluating and managing chemical risks – a major improvement made to the law when it was amended in 2016. The law defines potentially exposed or susceptible subpopulations as (emphasis added):

a group of individuals within the general population identified by [EPA] who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly. 

EPA must ensure that these and future new chemical SNURs provide protections for workers.  

Require notification for reasonably foreseen consumer uses 

Finally, several of the proposed SNURs in this batch failed to evaluate potential uses of the chemicals by consumers. Although EPA stated that consumer use was “not reasonably foreseen,” we were able to easily identify consumer applications of the chemical substances, such as the use of hyperpigmented ink in art projects. Thus, for chemicals with reasonably foreseen consumer risks, EPA should designate as a significant new use any applications of these substances in a consumer product.   

See our submitted comments for more details. 

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