proposed rule
Title: Significant New Use Rules on Certain Chemical Substances
Docket ID: EPA-HQ-OPPT-2018-0650
Agency: Environmental Protection Agency
Comments Close: December 31, 2018
Summary Index:
e-PMN Form for submission of a Significant New Use Notice
Source: EPA webinar September 16, 2015
The Environmental Protection Agency ‘is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 66 chemical substances which were the subject of premanufacture notices.’ This is to achieve four objectives:
Receive notice of any person's intent to manufacture or process a listed chemical substance before that activity begins.
Have an opportunity to review and evaluate data submitted in the notice.
Assess whether the prospective manufacture or processing is likely to present an unreasonable risk, and if so, take necessary regulatory action.
Identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
The Environmental Protection Agency proposes that persons who intend to manufacture (defined by statute to include import) or process any of these 66 chemical substances for an activity that is proposed as a “significant new use” to notify EPA at least 90 days before commencing that activity. A list of these 66 chemicals can be found in both the Federal Register website and 40 CFR part 721, subpart E. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
Under the Toxic Substances Control Act Section 5(a)(2), EPA has the authority to determine that a use of a chemical substance is a “significant new use” (SNUR). Relevant information for EPA to consider includes the toxicity of chemical substances and potential human exposures and environmental releases that may be associated with the conditions of use of the substances. The notification required by an SNUR, a Significant New Use Notice, obligates EPA to assess risks that may be associated with the significant new use, and, if necessary, regulate the proposed new use.
Regulatory responsibilities associated with chemicals included, or not included, in the TSCA inventory.
Source: Reach 24H Consulting Group
To establish a significant new use, EPA must determine that the use is not ongoing. In this proposed rule, November 15, 2018 was designated as the cutoff date for such determination.
EPA encourages those preparing SNUR submissions to include detailed information on human exposure and environmental release that may result from the significant new use of the chemical substances, and information on risks posed by the chemical substances compared to risks posed by potential substitutes.
Contributor: Post-Doctoral Fellow, Environmental Health
