[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16541-16542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0093]


Small Entity Compliance Guide: ``Juice HACCP''; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: Submit written comments concerning this SECG to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers

[[Page 16542]]

Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

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 Sec.  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 http://www.fda.gov/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 http://www.cfsan.fda.gov/guidance.html.

    Dated: March 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8263 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S