[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38439-38440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au09-74]
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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Draft Guidance for Industry: Guide to Minimize Microbial Food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availability of a draft guidance entitled ``Guidance for Industry: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draft guidance is intended to cover the entire leafy greens supply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 This draft guidance, when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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Safety (HFS-317), Center for Food Safety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written comments on the draft guidance to the Division of Dockets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electronic access to the draft guidance.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