[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38438-38439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0346]


Draft Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards of Tomatoes; 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availability of a draft guidance entitled ``Guidance for Industry: 
Guide to Minimize Microbial Food Safety Hazards of Tomatoes.'' This 
guidance is intended to cover the entire tomato supply chain, both 
domestic firms and foreign firms exporting tomatoes into the United 
States, to enhance the safety of tomatoes by recommending practices to 
minimize microbial food safety hazards and to prevent microbial 
contamination. This draft guidance, when finalized, will supplement 
existing FDA guidances, including the 1998 ``Guidance for Industry: 
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and 
Vegetables,'' which applies to fresh produce commodities, and the 2008 
``Guidance for Industry: Guide to Minimize Microbial Food Safety 
Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-
cut produce.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 2, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Food Safety (HFS-317), Center for Food Safety 
and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-436-2651. Submit 
written comments on the draft guidance to the Division of Dockets 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electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:  Michelle A. Smith, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2024.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry: Guide to Minimize Microbial Food Safety 
Hazards of Tomatoes.'' This draft guidance covers the growing,

[[Page 38439]]

harvesting, packing, processing, and distribution of tomatoes, along 
with retail and food service preparation. Such tomatoes may be grown 
and harvested either from an open field or a greenhouse; they may be 
packed or repacked either for the fresh market or for ``fresh-cut/
value-added processing'' (i.e., minimally processed, such as by slicing 
or dicing, and then bagged or prepackaged); and then shipped either to 
food service operations or retail establishments where they are offered 
for sale to the consumer. The use of the term ``tomatoes'' in this 
document includes raw agricultural commodities and fresh-cut/value-
added products. This draft guidance is based primarily on tomato 
industry guidelines issued in July 2008 (Ref. 1), along with agency 
experience and information from other recent public and private 
programs.
    FDA is issuing this draft guidance as Level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on the microbiological hazards that may 
result in contamination of fresh and fresh-cut tomatoes and the 
recommended control measures for such hazards in the growing, 
harvesting, packing, processing, and distribution of tomatoes, along 
with retail and food service preparation. 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. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (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(c) 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 publish 
notice in the Federal Register soliciting public comment on each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA will publish a 
60-day notice on the proposed collection of information in a future 
issue of the Federal Register.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments 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. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

V. References

    The following reference has been placed on display in the Division 
of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 
and may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday.
    1. North American Tomato Trade Workgroup and United Fresh 
Produce Association. ``Commodity Specific Food Safety Guidelines for 
the Fresh Tomato Supply Chain.'' 2d ed., July 2008. Accessed online 
at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm171695.htm.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18453 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S