[Federal Register Volume 73, Number 37 (Monday, February 25, 2008)]
[Notices]
[Pages 10037-10038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3417]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA-2008-D-0108 (formerly Docket No. 2006D-0079)]


Guidance for Industry: Guide to Minimize Food Safety Hazards for 
Fresh-cut Fruits and Vegetables; 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 final guidance document entitled ``Guidance for 
Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut 
Fruits and Vegetables'' (the fresh-cut guidance or guidance). 
Previously, FDA announced the availability of the fresh-cut guidance as 
a ``draft final'' document, pending approval by the Office of 
Management and Budget (OMB) of the information collection provisions in 
the guidance. FDA is publishing this notice to announce that the fresh-
cut guidance is now final. The text of the guidance has not changed 
from the previously published draft final version. The fresh-cut 
guidance complements FDA's current good manufacturing practice (CGMP) 
requirements for foods by providing specific guidance on the processing 
of fresh-cut produce. The fresh-cut guidance and the CGMP regulations 
are intended to assist processors in minimizing microbial food safety 
hazards common to the processing of most fresh-cut fruits and 
vegetables sold to consumers and retail establishments in a ready-to-
eat form.

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

ADDRESSES: Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document. Submit written 
requests for single copies of the guidance to the Office of Food Safety 
(HFS-317), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1700 or FAX: 301-436-2651. Send one self-addressed adhesive label 
to assist the Center in processing your request.

FOR FURTHER INFORMATION CONTACT:  Rhoma Johnson, Center for Food Safety 
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2066 or FAX: 301-
436-2651.

SUPPLEMENTARY INFORMATION:

I. Background

    Fresh-cut fruits and vegetables are minimally processed fruits and 
vegetables that have been altered in form by peeling, slicing, 
chopping, shredding, coring, or trimming, with or without washing or 
other treatment, prior to being packaged for use by the consumer or a 
retail establishment. The methods by which produce is grown, harvested, 
and processed may contribute to its contamination with pathogens and, 
consequently, the role of the produce in transmitting foodborne 
illness. Factors such as the high degree of handling and mixing of the 
product, the release of cellular fluids during cutting or chopping, the 
high moisture content of the product, the absence of a step lethal to 
pathogens, and the potential for temperature abuse in the processing, 
storage, transport, and retail display all enhance the potential for 
pathogens to survive and grow in fresh-cut produce.
    On March 6, 2006, FDA published in the Federal Register a notice 
entitled ``Draft Guidance for Industry: Guide to Minimize Food Safety 
Hazards of Fresh-Cut Fruits and Vegetables'' (71 FR 11209) (the March 
2006 notice). FDA gave interested persons 60 days to comment on the 
draft guidance. The comment period closed on May 5, 2006. The draft 
guidance was revised based on public comments. The draft guidance 
contained information collection provisions subject to review by OMB 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
Under the PRA, Federal agencies must obtain approval from OMB for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, in 
the March 2006 notice (71 FR 11209), FDA gave interested persons 60 
days to comment on the information collection provisions in the draft 
guidance. After providing the 60-day notice requesting public comment, 
section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to 
submit the proposed collection to OMB for review and clearance. In 
compliance with 44 U.S.C. 3507, FDA submitted the proposed collection 
of information to OMB for review and clearance.
    On March 13, 2007, FDA published in the Federal Register a notice 
announcing the availability of a ``Draft Final Guidance for Industry: 
Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and 
Vegetables'' (72 FR 11364). This document was issued as a ``draft 
final'' guidance pending OMB approval of the collection of information. 
FDA announced OMB's approval of the collection of information in a 
notice published on October 19, 2007 (72 FR 59295). With OMB approval, 
FDA is publishing this notice announcing that the fresh-cut guidance is 
final and providing an OMB control number (See section II of this 
document).
    The fresh-cut guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The fresh-cut guidance 
is intended to assist processors in minimizing microbial food safety 
hazards common to the processing of most fresh-cut fruits and 
vegetables sold to consumers and retail establishments in a ready-to-
eat form. This guidance represents FDA's current thinking on the 
microbiological hazards presented by most fresh-cut fruits and 
vegetables and the recommended control measures for such hazards in the 
processing of such produce. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. You 
may use an alternative approach if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0609.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
document at any time. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one

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paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at the following Web site: http://www.cfsan.fda.gov/guidance.html.

    Dated: February 15, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3417 Filed 2-22-08; 8:45 am]
BILLING CODE 4160-01-S