Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing of Juice (21 CFR Part 120)
Extension without change of a currently approved collection
No
Regular
Approved without change
09/24/2007
07/30/2007
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
09/30/2010
36 Months From Approved
09/30/2007
21,978,653
0
15,035
358,466
0
360,930
0
0
0
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.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
0466 42 USC 264 7-10-2007.doc
Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice