[Federal Register: June 15, 2004 (Volume 69, Number 114)]
[Page 33393-33394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0258]

Produce Safety From Production to Consumption: An Action Plan to 
Minimize Foodborne Illness Associated With Fresh Produce; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of public meeting.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to elicit information from stakeholders concerning key elements 
of FDA's new produce safety action plan entitled ``Produce Safety From 
Production to Consumption: An Action Plan to Minimize Foodborne Illness 
Associated With Fresh Produce.'' The new produce safety action plan 
will be forthcoming and posted at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.foodsafety.gov /dms/fs-

toc.html prior to the public meeting. We request that those who speak 
at the meeting or otherwise provide FDA with their comments focus on 
the questions set out in section II of this document concerning the 
draft of the produce safety action plan.

DATES: The public meeting will be held in College Park, MD, on Tuesday, 
June 29, 2004, from 1 p.m. to 4 p.m. We request that all those planning 
to attend the meeting register prior to the meeting. For security 
reasons and due to space limitations, we recommend that you register at 
least 5 days prior to the meeting. You may register via the Internet 
and also by fax until close of business 5 days before the meeting, 
provided that space is available (see FOR FURTHER INFORMATION CONTACT). 
In addition to participating at the public meeting, you may submit 
written or electronic comments until July 24, 2004.

ADDRESSES: The public meeting on Tuesday, June 29, 2004, will be held 
at the Harvey W. Wiley Federal Bldg., FDA, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-
    Submit written comments 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

FOR FURTHER INFORMATION CONTACT: Amy L. Green, Center for Food Safety 
and Applied Nutrition (HFS-306), FDA, 5100 Paint Branch Pkwy., College 
Park, MD, 301-436-2025, FAX: 301-436-2651, or e-mail: 


I. Background

    In 1997, the Produce and Imported Food Safety Initiative (PIFSI) 
was released, which brought increased attention and resources to 
produce and microbial food safety. In 1998, as a part of this 
initiative, FDA issued guidance on good agricultural practices (GAPs) 
and the good manufacturing practice regulations (GMPs) for fresh 
produce. This guidance entitled ``Guide to Minimize Microbial Food 
Safety Hazards for Fresh Fruits and Vegetables,'' (1998 guidance or 
1998 GAPs/GMPs guidance), is broad in scope and covers all fresh 
produce consumed in the United States that is produced domestically and 
abroad and practices commonly involved in the production and packing of 
fresh produce. The 1998 GAPs/GMPs guidance has been well received and 
widely adopted; however, foodborne illness outbreaks associated with 
fresh produce continue to occur.
    The draft 2004 produce safety action plan continues the 1997 
initiative, building on experience from earlier efforts such as the 
development and implementation of the 1998 GAPs/GMPs guidance, 
inspections of farms and produce packing facilities, and investigations 
of foodborne illness outbreaks. The draft of the 2004 produce action 
plan addresses all principal points between the farm and table where 
contamination of produce could occur. It covers fresh fruit and 
vegetables in their native form and raw, minimally processed products, 
i.e., raw, pre-cut, or fresh-cut fruits and vegetables that have 
received some processing to alter their form (such as peeling, slicing, 
chopping, shredding, coring, trimming, or mashing), but have not been 
subject to a thermal process that would reduce, control, or eliminate 
microbial hazards. The draft action plan is not intended to cover 
processed products such as juice, or agricultural products other than 
fruits and vegetables, such as tree nuts.
    In the 7 years since PIFSI began, many changes have occurred in the 
industry and much new knowledge and information are available. FDA 
believes that a good first step in moving the produce safety action 
plan forward is to engage and solicit the views of other Government 
agencies at Federal, State, and local levels, from industry groups, and 
from the public generally. The public meeting and comment period are 
intended to provide that opportunity.

[[Page 33394]]

    FDA has drafted the set of questions below to help focus comments 
presented at the public meeting or otherwise communicated to the 

II. Questions

    1. What concepts or underlying principles should guide the 2004 
Produce Safety Action Plan? Are the seven objectives in the working 
draft appropriate for achieving the overarching goal to minimize 
foodborne illness associated with the consumption of fresh produce?
    2. What major practices contribute to the contamination of fresh 
produce by harmful pathogens? What intervention strategies will 
prevent, reduce, or control this contamination?
    3. The produce action plan covers fresh fruits and vegetables that 
have not been heat treated to reduce, control, or eliminate pathogens, 
or otherwise significantly processed. The draft action plan is not 
intended to cover frozen fruits and vegetables, fruit and vegetable 
juices, or other commodities such as tree nuts that are neither fruits 
nor vegetables and not typically regarded as produce. Should the 
produce action plan cover additional foods? If so, which foods?
    4. What measurements should be used to measure progress toward the 
overarching goal (to minimize foodborne illness associated with fresh 
produce consumption)? What measures should be used to measure progress 
toward the individual objectives?
    5. Does FDA's current GAPs/GMPs guidance (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.foodsafety.gov 

/dms/prodguid.html) need to be expanded or otherwise revised? If yes, 
please describe generally the areas that need expansion or other 
    6. In today's production and food preparation environments (farms, 
packing houses, retail establishments, and consumers), what conditions, 
practices, or other factors are the principal contributors to 
contamination of produce with a pathogen? What interventions would 
reduce, control, or eliminate this contamination?
    7. There is broad variation within food operations including 
variations in size of establishments, the nature of the commodity 
produced, the practices used in production, and the vulnerability of a 
particular commodity to microbial hazards. How, if at all, should the 
produce action plan be structured to take into account such variation? 
For example, should there be different sets of interventions for 
identifiable segments of the fresh produce industry?
    8. What roles can and should Federal, State, and local agencies and 
the food industry play in developing and implementing action items to 
help achieve the objectives in this action plan?
    9. Are there existing food safety systems or standards (such as 
international standards) that FDA should consider as part of the 
agency's development and implementation of a produce safety action 
plan? Please identify these systems or standards and explain what their 
consideration might contribute to this effort.

III. Registration

    You may register through FDA's Web site http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/ 

and choose ``Public Meetings,'' by fax, or e-mail (see FOR FURTHER 
INFORMATION CONTACT). For security reasons and due to space 
limitations, we recommend that you register at least 5 days prior to 
the meeting. Registration will be accepted on a first-come-first-serve 
basis. You may register until close of business June 22, 2004. If you 
need special accommodations due to a disability, please inform the 
contact person at least 7 days in advance (see FOR FURTHER INFORMATION 
CONTACT). There is no registration fee for this public meeting, but 
early registration is encouraged because space is limited, and it will 
expedite entry into the building and its parking area. If you require 
parking, please include the vehicle make and tag number, if known, on 
your registration form. Because the meeting will be held in a Federal 
building, you should also bring a photo identification (ID) and plan 
for adequate time to pass through security screening systems. If you 
would like to make oral comments at the meeting, please specify your 
interest in speaking when you register. The amount of time for each 
oral presentation may be limited based upon the number of requests to 
speak. FDA encourages individuals or firms with relevant data or 
information to present such information at the meeting or in written 
comments to the record.

IV. Transcripts

    A transcript will be made of the proceedings of the meeting. You 
may request a copy of the meeting transcript from FDA's Freedom of 
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, rm. 12A-16, Rockville, MD 20857, approximately 30 working days 
after the meeting at a cost of 10 cents a page. The transcript of the 
public meeting and all comments submitted will be available for public 
examination at the Division of Dockets Management (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Comments

    In addition to presenting oral comments at the public meeting, 
interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the subject of this 
meeting. 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 the brackets in the heading of this document. Received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: June 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13544 Filed 6-10-04; 1:35 pm]