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View ICR - OIRA Conclusion

OMB Control No: 2070-0012	ICR Reference No: 201112-2070-001
Status: Historical Active	Previous ICR Reference No: 201004-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.15
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/21/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/07/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for 3 years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved	12/31/2012
Responses	2,126	0	2,518
Time Burden (Hours)	117,163	0	117,512
Cost Burden (Dollars)	0	0	0

Abstract: Section 5 of the Toxic Substances Control Act (TSCA) requires manufacturers and importers of new chemical substances to submit to EPA a notice of intent to manufacture or import a new chemical substance 90 days before manufacture or import begins. (Formerly accomplished via paper documents, but now done electronically!) EPA reviews the information contained in the notice to evaluate the health and environmental effects of the new chemical substance. On the basis of the review, EPA may take further regulatory action under TSCA, if warranted. If EPA takes no action within 90 days, the submitter is free to manufacture or import the new chemical substance without restriction. TSCA section 5 also authorizes EPA to issue Significant New Use Rules (SNURs). EPA uses this authority to take follow-up action on new or existing chemicals that may present an unreasonable risk to human health or the environment if used in a manner that may result in different and/or higher exposures of a chemical to humans or the environment. Once a use is determined to be a significant new use, persons must submit a notice to EPA 90 days before beginning manufacture, processing or importation of a chemical substance for that use. Such a notice allows EPA to receive and review information on such a use and, if necessary, regulate the use before it occurs. Finally, TSCA section 5 also permits applications for exemption from section 5 review under certain circumstances. An applicant must provide information sufficient for EPA to make a determination that the circumstances in question qualify for an exemption. In granting an exemption, EPA may impose appropriate restrictions. This information collection addresses the reporting and recordkeeping requirements associated with TSCA section 5.