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Small Entity Compliance Guide: “Juice HACCP”; Availability

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of January 19, 2001, entitled “Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice.” This SECG, entitled “Juice HACCP,” is intended to set forth in plain language the requirements of that final rule and to help small businesses understand the regulation.


Submit written or electronic comments on the SECG at any time.


Submit written comments concerning this SECG to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Start Printed Page 16542Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to​dockets/​ecomments. Submit written requests for single copies of the SECG to Amy Green, Center for Food Safety and Applied Nutrition (CFSAN) (see FOR FURTHER INFORMATION CONTACT). Send one self-adhesive address label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG.

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Amy Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025, FAX 301-436-2651.

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I. Background

In the Federal Register of January 19, 2001 (66 FR 6138), FDA issued a final rule to ensure the safe and sanitary processing of fruit and vegetable juices. The regulations in part 120 (21 CFR part 120) mandate the application of HACCP principles to the processing of these foods. HACCP is a preventive system of hazard control. The effective dates of the final rule are staggered and based on the size of the business. For very small businesses (as defined in § 120.1(b)(1), the effective date is January 20, 2004. For small businesses, the effective date was January 21, 2003, and for all other size businesses the effective date was January 22, 2002.

FDA examined the economic implications of that final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-602). The agency determined that the final rule would have a significant economic impact on a substantial number of small entities.

In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121), FDA is making available this SECG stating in plain language the requirements of the juice HAACP regulations.

FDA is issuing this SECG as level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the agency's current thinking on the subject. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments on the SECG entitled “Juice HACCP.” Submit a single copy of electronic comments to​dockets/​ecomments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of SECG and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

The SECG also may be viewed on a personal computer with access to the Internet at​guidance.html.

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Dated: March 27, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-8263 Filed 4-3-03; 8:45 am]