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On 17 April 2020 the U.S. Environmental Protection Agency (EPA) proposed that three substances become subject to significant new use rules (SNURs) pursuant to Section 5(a)(2) of the Toxic Substances Control Act (TSCA). Comments are due by 18 May 2020.
Three substances currently undergoing premanufacture review from the EPA have been preliminarily determined to pose no foreseeable unreasonable risks to human health or the environment under the reported intended conditions of use. However the EPA has identified additional conditions of use not identified in the substances' premanufacture notices (PMNs) that are reasonably foreseeable to cause risk of injury. Thus the agency is proposing that these additional conditions of use not reported in the PMNs be designated significant new uses. Substances potentially affected by these SNURs are:
- Butanoic acid, 4- (dimethylamino)-, ethyl ester (PMN P-18-59, CAS RN 22041-23-2)
- 1-Butanaminium, 4- amino-N-(2-hydroxy-3-sulfopropyl)- N,N-dimethyl-4-oxo-, N-coco alkyl derivs., inner salts. (PMN P-18-60, CAS RN 2041102-83-2)
- Indium manganese yttrium oxide (PMN P-18-381, CAS RN 1239902-45-4)
If adopted, the EPA would require that manufacturers notify the agency that they intend to commercialize these substances as described in the SNURs. The notifications must be made at least 90 days prior to engaging in any commercial activity. Businesses may not commercialize these substances until the EPA has affirmatively decided on the substances' potential risk of injury to human health or the environment. Failure to comply with these requirements would constitute a violation under the TSCA. Last, the adoption of the SNUR could also trigger other regulatory obligations under Sections 12 (b) and 13 of the TSCA.
Businesses potentially affected by these proposed SNURs may submit comments via the Federal eRulemaking portal by accessing docket number EPA–HQ–OPPT–2020–0138. Mail and hand delivery options are available as well.