Several NGOs say the US EPA’s effort to address risks posed by reasonably foreseen uses of a new chemical under TSCA with only a significant new use rule (Snur) is "unlawful".
And despite industry groups applauding this "Snur-only" approach, consumer advocates are asking for the EPA to reverse course.
The comments have come in response to a consultation on 13 Snurs, issued last month. Unlike hundreds of other Snurs released since August, this batch related to substances which were not subject to section 5(e) consent orders.
For each of the 13 substances, the EPA did not have a concern with its intended use, as specified in its pre-manufacture notice (PMN), but did see possible issues with reasonably foreseen uses. It therefore issued determinations that the substances were not likely to present an unreasonable risk, and proposed Snurs in tandem with those findings to address uses outside the PMN.
The Natural Resources Defense Council challenged the EPA in court when the agency floated plans last year to take such an approach. This lawsuit was ultimately dropped when the agency demonstrated it not had, in fact, been following the Snur-only plan.
But the agency entered new territory by issuing the 13 non-5(e) Snurs after the ligation ended. And environmental advocates, in turn, have continued to protest that the approach is not in keeping with the agency’s mandates under the reformed TSCA.
The Environmental Defense Fund (EDF) says that the EPA’s Snur-only approach is "unlawful".
The EPA can only make a section 5(a)(3)(C) ‘not likely to present an unreasonable risk’ finding based on the substance as a whole, considering all of its conditions of use, said the EDF.
"EPA has never articulated how its Snur-only approach is consistent with TSCA, or why it is sufficiently health-protective," it added.
Safer Chemicals Healthy Families (SCHF) and the NRDC agreed in joint comments that the proposed Snurs represent a step to "circumvent the law and weaken the programme".
The groups noted that the 2016 amendments to TSCA require that EPA make an affirmative determination that a new substance is unlikely to be harmful before it can enter commerce, and increased the agency’s authorities to require testing.
But despite adhering to the law in its first two years, said the groups, industry opposition has led to the EPA "reversing this progress through a series of steps to dismantle a long-standing PMN review process and replace it with one that is both unlawful and significantly less protective of health and the environment".
The groups are urging the EPA to withdraw its ‘not likely’ determinations for the 13 substances and apply section 5(e) orders on them, and to update the Snurs in keeping with the orders.
In the absence of such a reversal, the organisations also advocated for specific changes to the existing proposed Snurs, which they said as drafted "have limited, barebones provisions that will be insufficient in implementing protections for health and the environment".
Industry, animal rights backers
Not all stakeholders, however, agreed that the Snur-only approach is out of step with the law’s requirements.
Writing on behalf of a confidential PMN submitter for one of the substances subject to a Snur, Herb Estreicher, a partner with Keller and Heckman, said that proposing a Snur without a consent order is "consistent with longstanding EPA practice … is fully protective of health and the environment, and is sound from a policy perspective".
The Chemical Users Coalition – a downstream users group representing several aerospace and technology giants – said it thinks the proposed Snurs are "generally consistent" with the law’s requirements. To the extent the approach will improve the agency’s ability to provide more timely review of PMNs, it added, the CUC supports it.
The Semiconductors Industry Association (SIA) similarly said it is "an appropriate approach and should be applied to other chemical substances".
Meanwhile, the Physicians Committee for Responsible Medicine (PCRM), a nonprofit advocating for ethical medical practices, said it "enthusiastically supports" the EPA’s approach, which it says is consistent with TSCA’s requirements to reduce and replace the use of vertebrate animals in testing.
Comments on the 13 Snurs were due on 15 November. The agency will evaluate submitted feedback before finalising the rules.