View Information Collection Request (ICR) Package

OMB Control No: 0910-0466	ICR Reference No: 200707-0910-005
Status: Historical Active	Previous ICR Reference No: 200404-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing of Juice (21 CFR Part 120)
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: 09/24/2007
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2010	36 Months From Approved	09/30/2007
Responses	21,978,653	0	15,035
Time Burden (Hours)	358,466	0	360,930
Cost Burden (Dollars)	0	0	0

Abstract: FDA's mandate to ensure the safety of the nation's food supply is derived principally from the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.). Under the act, FDA has authority to ensure that all foods in interstate commerce, or that have been shipped in interstate commerce, are not contaminated or otherwise adulterated, are produced and held under sanitary conditions, and are not misbranded or deceptively packaged. Under 21 U.S.C. 371, the act authorizes the agency to promulgate regulations for its efficient enforcement. The agency also has authority under the Public Health Service Act (42 U.S.C. 264) to promulgate and enforce regulations to prevent the introduction, transmission or spread of communicable diseases from one State, territory or possession to another, or from outside the United States into this country. The "Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice" regulations establish Part 120 of Title 21 of The Code of Federal Regulations, which requires the use of (HACCP) methods by processors of fruit and vegetable juices. HACCP is a system of preventive controls, which was advocated by President Clinton in his remarks on Food Safety Regulations on October 2, 1997. The rationale in establishing a HACCP system of preventive controls is to design and check the process so that the final product is not contaminated - not test for contamination after it may have taken place. Under HACCP, processors of fruit and vegetable juices establish and follow a pre-planned sequence of operations and observations (the HACCP plan) designed to avoid one or more specific food hazards, and thereby ensure that their products are safe, wholesome, and not adulterated; in compliance with section 402 of the act (21 U.S.C. 342). The foundation of a HACCP system is the use of current good manufacturing processes (CGMPs) and prerequisite program standard operating procedures (SOPs). The hazard analysis and HACCP plan builds on this foundation. By design, the HACCP method relies heavily on monitoring the critical control points established in the HACCP plan, and periodically recording the conditions at control points during the processing operations leading to the finished product. These recorded observations are necessary to verify adherence to the established control conditions during the critical processing operations, and thereby demonstrate that the finished food is safe. Information development and record keeping are essential parts of any HACCP system. The information collection requirements of these regulations are narrowly tailored to focus on the development of appropriate controls and documenting those aspects of processing that are critical to food safety. Through these regulations, FDA is implementing its authority under 21 U.S.C. 342(a)(4). The information development and record keeping requirements of these regulations are likewise an implementation of 21 U.S.C. 342(a)(4). Under the authority of section 704 of the act (21 U.S.C. 374), FDA periodically inspects the facilities of, and collects samples from, domestic food processors to determine whether food is prepared, processed, and packaged in compliance with the adulteration (section 402), (21 U.S.C. 342 (a)(3) and (a)(4)), misbranding, and other provisions of the act. FDA also inspects and samples foods imported to the U.S. under the authority of section 801 of the act (21 U.S.C. 381). Compliance of foods with the act and its derivative regulations can often be established only by costly and statistically imperfect sampling and laboratory testing of finished products for physical, chemical, or microbial adulterants. HACCP procedures can largely eliminate the need for extensive testing of finished products. HACCP procedures yield products that are known, with a high degree of confidence, to be free of the hazards controlled by the plan.

Authorizing Statute(s): None

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:
	72 FR 27138	05/14/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 40885	07/25/2007
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	21,978,653	15,035	21,963,618
Annual Time Burden (Hours)	358,466	360,930	-2,464
Annual Cost Burden (Dollars)	0	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: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Jonnalynn Capezzuto 3018274659

View ICR - OIRA Conclusion