[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38439-38440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0348]


Draft Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards of Leafy Greens; 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availability of a draft guidance entitled ``Guidance for Industry: 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 Leafy Greens.'' This 
draft guidance is intended to cover the entire leafy greens supply 
chain, both domestic firms and foreign firms exporting leafy greens 
products into the United States, to enhance the safety of leafy greens 
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 This draft guidance, when 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 to Industry: Guide to Minimize Microbial Food Safety Hazards 
for Fresh Fruits and Vegetables,'' which applies to fresh produce 
commodities, and the 2008 ``Guidance to 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Food Safety (HFS-317), Center for Food Safety 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written comments on the draft guidance to the Division of Dockets 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electronic access to the draft guidance.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:  Amy Green, Center for Food Safety and 
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2025.

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 Leafy Greens.'' This draft guidance covers leafy greens that 
are grown and harvested then packed or cooled for fresh market or for 
``fresh-cut/value-added processing'' (i.e., minimally processed, such 
as chopped or shredded, moved through a series of washes, and then 
bagged or prepackaged), shipped to food service or retail 
establishments, and offered for

[[Page 38440]]

sale to the consumer. The term ``leafy greens'' as used in this draft 
guidance includes raw agricultural commodities and fresh-cut/value-
added products. Examples of leafy greens include iceberg lettuce, 
romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce 
(immature lettuce or leafy greens), escarole, endive, spring mix, 
spinach, cabbage, kale, arugula, and chard. Leafy greens do not include 
herbs such as cilantro and parsley.
    This draft guidance is based primarily on leafy greens industry 
guidelines issued in 2006 (Ref. 1), along with agency experience and 
information from other recent public and private programs. The leafy 
greens industry has since updated and supplemented its 2006 guidelines 
with additional recommendations on the production and harvest of leafy 
greens that include quantitative metrics and measures to assist 
industry in implementing the guidelines (Ref. 2). This draft guidance 
does not include these more specific and quantitative metrics and 
measures. We are considering the extent to which more specific 
measures, including metrics, should be utilized to help verify the 
implementation and efficacy of the Federal recommendations and industry 
practices. We are also evaluating the extent to which metrics can be 
applied to diverse geographic areas within the United States and 
internationally. FDA invites comment on whether such information should 
be incorporated into the guidance, when finalized.
    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 presented by 
fresh and fresh-cut leafy greens products and the recommended control 
measures for such hazards in production and harvesting, postharvest 
operations, processing, distribution, and retail and food service 
handling 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. 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 references have 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. Gorny, J., et al., editors, ``Commodity Specific Food Safety 
Guidelines for the Lettuce and Leafy Greens Supply Chain'' (1st 
ed.); International Fresh-cut Produce Association, Produce Marketing 
Association, United Fresh Fruit and Vegetable Association, Western 
Growers Association; April 25, 2006. Accessed online at http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm.
    2. See ``Commodity Specific Food Safety Guidelines for the 
Production and Harvest of Lettuce and Leafy Greens''; Produce 
Marketing Association, United Fresh Fruit and Vegetable Association, 
and Western Growers Association; last revised June 13, 2008. 
Accessed online at http://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08.pdf. (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18451 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S