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View ICR - OIRA Conclusion

OMB Control No: 2070-0012	ICR Reference No: 201507-2070-003
Status: Historical Active	Previous ICR Reference No: 201112-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.16
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Final Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/03/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/20/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved	12/31/2015
Responses	2,854	0	2,126
Time Burden (Hours)	117,176	0	117,163
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.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	2,854	2,126	336	392
Annual Time Burden (Hours)	117,176	117,163	-246	259
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The burden changes analyzed in this ICR revision relate to both program changes and adjustments related to EPA's direct final rule. As explained in the supporting statement, a 258 hour burden adjustment increase is directly related to CDX registration activities that are already required under the e-PMN rule. The adjustment is related to the number of new and replacement employees of firms engaged in TSCA section 5 activities who need to register in CDX. In addition, EPA estimates a program change increase of 276 burden hours associated with respondents' familiarization with the requirements of the direct final rule, as well as a 522 burden hour program change reduction related to the electronic submission of bona fides as required by the direct final rule.