Information Collection Request; Collection of Information for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances, Significant New Use Reporting Requirements for Chemical Substances, and Significant New Use Rules for Existing Chemicals

1 organizations filed 2 public comments on Information Collection Request; Collection of Information for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances, Significant New Use Reporting Requirements for Chemical Substances, and Significant New Use Rules for Existing Chemicals, at the Environmental Protection Agency. The comment window closed 180d ago.

Abstract

This information collection request addresses the reporting and recordkeeping requirements associated with the new chemicals review and regulatory program administered by EPA under section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the “Lautenberg Act”) (15 U.S.C. 2604). TSCA section 5 requires that any person who proposes to manufacture (which includes import) a “new chemical” (i.e., a chemical not listed on the TSCA section 8(b) Inventory) must provide a premanufacture notice (PMN) or an exemption application to EPA at least 90 days prior to commencing manufacture of that chemical and that EPA review such notice and take action as appropriate. EPA considers certain genetically engineered microorganisms to be chemical substances for purposes of the notification requirements found in TSCA section 5; the 90-day notice for microorganisms is a Microbial Commercial Activity Notice (MCAN). Related to EPA-HQ-OPPT-2017-0645

Commenters (1)

• American Chemistry Counciltrade assoc.

  2 filings · confidence 97%