Document ID: EPA-HQ-OPPT-2020-0138-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-03-22T04:00Z

﻿Public Comments on Proposed Significant New Use Rule (20-4.B)
and EPA Responses  -  Public Docket EPA-HQ-OPPT-2020-0138

EPA received public comments from two identifying entities on the proposed rule. The Agency's responses are described below. In addition, EPA received one anonymous comment. It was general in nature and did not pertain to the proposed rule; therefore, no response is required.
Comment Specific to the SNUR for PMN P-18-381
Comment: One commenter noted that the SNUR for the chemical substance which was the subject of P-18-381 identifies as a significant new use "manufacture or processing in a manner that results in inhalation exposure." However, based on information in the premanufacture notice (PMN) submission and discussions with EPA during the PMN review period, inhalation exposure was expected and assessed under the intended conditions of use. The commenter recommended that EPA restate this significant new use to avoid confusion.
Response:  EPA agrees with the commenter that this significant new use was included erroneously. This term has been removed from the final SNUR. Instead, EPA is designating manufacture or processing without respiratory protection as a significant new use.
Clarification on Chemicals Subject to the Proposed Rule
Comment: One commenter noted that in Unit IV of the proposed rule, the first sentence states "EPA is proposing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E", which contains a detailed list of many chemicals. However, just a few paragraphs following this statement, the proposed rule states that only three substances (P-18-59, P-18-60, and P-18-381) are subject to the proposed rules. It is later stated in Unit X, paragraph A that "This proposed rule would establish SNURs for 3 new chemical substances that were the subject of PMNs". The commenter suggested that the language in Unit IV of the proposed rule should be revised to clarify that the proposed rule is meant to add these three chemicals to the list in 40 CFR part 721.
Response: EPA appreciates the commenter's feedback. The first sentence of Unit IV was revised for clarity in subsequent proposed SNUR notices. Since this comment pertains only to language in the proposed rule and not to language in the final rule or the regulatory text of these SNURs, no changes to the final rule are needed based on the comment.