View Information Collection Request (ICR) Package

OMB Control No: 0910-0186	ICR Reference No: 201207-0910-013
Status: Historical Active	Previous ICR Reference No: 200905-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Irradiation in the Production, Processing and Handling of Food
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: 08/31/2012
	Date Received in OIRA: 07/31/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	1,020	0	1,020
Time Burden (Hours)	1,020	0	1,020
Cost Burden (Dollars)	0	0	0

Abstract: Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, ? 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum (or minimum and maximum) energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2) requires that the label or accompanying labeling bear adequate directions for installation and use and a statement supplied by FDA that indicates maximum dose of radiation allowed. Section 179.26(c) requires that the label or accompanying labeling bear a logo and a radiation disclosure statement. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.)

Authorizing Statute(s): US Code: 21 USC 321 Name of Law: FFDCA
US Code: 21 USC 348 Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 29352	05/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 43842	07/26/2012
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Irradiation in the Production, Processing and Handling of Food
Irradiation in the Production, Processing and Handling of Food

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,020	1,020
Annual Time Burden (Hours)	1,020	1,020
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

Annual Cost to Federal Government: $427

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

View ICR - OIRA Conclusion