[Federal Register: April 22, 2005 (Volume 70, Number 77)]
[Proposed Rules]               
[Page 20852-20854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap05-17]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 2005N-0147]

 
Sprout Safety Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to elicit information on the current science related to 
foodborne illness associated with the consumption of sprouts. In 
October 2004, FDA released a produce safety action plan entitled 
``Produce Safety from Production to Consumption: 2004 Action Plan to 
Minimize Foodborne Illness Associated with Fresh Produce Consumption'' 
(Produce Action Plan). One item in the Produce Action Plan is to 
initiate rulemaking to minimize foodborne illness associated with the 
consumption of sprouted seeds. However, because of the complexities of 
the issues and the uncertainty about what the current science could 
support, FDA believes that it would be of value to hold a public 
meeting to gather information relevant to a possible regulation. We 
request that those who speak at the meeting, or otherwise provide FDA 
with their comments, focus on the questions relating to the microbial 
safety of seeds destined for sprouting and sprouted seeds set out in 
section II of this document.

DATES: The public meeting will be held in College Park, MD, on Tuesday, 
May 17, 2005, from 8:30 a.m. to 5 p.m. We request that everyone 
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 business days before 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 in the public 
meeting, you may submit written or electronic comments until July 18, 
2005.

ADDRESSES: The public meeting will be held at the Harvey W. Wiley 
Federal Bldg., Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-
3835.
    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), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 301-436-2025, FAX: 301-436-2651, 
or e-mail: amy.green@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Since 1996, FDA has responded to 27 outbreaks of foodborne illness 
in the United States for which raw or lightly cooked sprouts were the 
confirmed or suspected vehicle for the illness. During

[[Page 20853]]

this 9-year period, sprouts accounted for 40 percent of all foodborne 
illness outbreaks associated with fresh produce and approximately 20 
percent of the reported illnesses. The 27 outbreaks accounted for an 
estimated 1,636 reported cases of illness. Although the sprouts 
associated with these outbreaks have been primarily alfalfa, clover, or 
mung bean sprouts, FDA is concerned about the foodborne illness risk 
associated with all types of raw and lightly cooked sprouts. Thus, the 
agency has issued several advisories that warn consumers of the risks 
associated with consumption of raw or lightly cooked sprouts. The 
sprouts involved with the outbreaks have been generally of U.S. origin 
while the seeds from which the sprouts have been produced have been 
primarily of non-U.S. origin. To date, the causative agents have been 
Salmonella and Escherichia coli O157.
    Sprouts present a special food safety challenge because the 
conditions that promote sprouting of the seed (e.g., temperature, 
humidity, available nutrients) also promote the growth of pathogens if 
pathogens are present. Seed appears to be the source of contamination 
in most of the foodborne illness outbreaks associated with sprout 
consumption. However, insanitary conditions at the sprouting facility 
appear to have exacerbated any seed contamination problems.
    In October 1999, FDA issued a guidance entitled ``Guidance for 
Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds.'' 
This guidance recommends preventive controls to assist all parties 
involved in the production of sprouts (seed producers, seed 
conditioners and distributors, and sprout producers) to reduce the risk 
of sprouts serving as a vehicle for foodborne illness. The guidance is 
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://vm.cfsan.fda.gov/dms/sprougd1.html. Specific 

recommendations in this guidance include development and implementation 
of good agricultural practices and good manufacturing practices in the 
production and handling of seeds and sprouts, seed disinfection 
treatments, and microbial testing of spent irrigation water before the 
sprouts enter the food supply. At the same time, FDA issued a second 
guidance entitled ``Guidance for Industry: Sampling and Microbial 
Testing of Spent Irrigation Water during Sprout Production,'' which 
contains recommendations to assist sprout producers in testing spent 
irrigation water for pathogens before sprout products enter the food 
supply. This second guidance is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://vm.cfsan.fda.gov/dms/sprougd2.html.
 FDA also served as a technical consultant to the 

California Department of Health Services, who, in cooperation with the 
sprout industry, developed a video to advise the sprout industry on how 
to produce safer product.
    For several years following release of FDA's guidance documents, 
foodborne illness outbreaks associated with alfalfa and clover sprouts 
appeared to diminish. In 2000, there was only one sprout-associated 
outbreak, compared to 6 outbreaks in 1999. Between 2000 and 2002, 
salmonellosis emerged as a foodborne illness associated with 
consumption of raw or lightly cooked mung bean sprouts. Recently, 
alfalfa sprouts remerged as a significant vehicle for foodborne 
illness, with 5 outbreaks in 2003 and 2 outbreaks in 2004.
    We have observed a downward trend in the average number of cases 
associated with an outbreak since issuance of FDA's sprout guidances. 
Between 1996 and 1999, there were 14 outbreaks with 1,364 reported 
illnesses, an average of 97 cases per outbreak. Since FDA issued its 
sprout guidances, there have been 13 outbreaks with 272 reported 
illnesses, an average of 21 cases per outbreak.
    FDA believes that the 1999 sprout guidances have had a significant 
positive effect on reducing both the number of outbreaks associated 
with sprouts and on the number of cases per outbreak. However, based on 
continuing outbreaks associated with raw and lightly cooked sprouts, 
the agency is concerned that further action may be needed to ensure 
sustained adoption of effective preventive controls by the seed and 
sprout industry as a whole. In October 2004, FDA released the Produce 
Action Plan. Now, FDA is considering whether a proposed regulation is 
needed to codify and expand on the existing sprout guidance.
    FDA believes that a good first step to improving the safety of 
sprouts is to engage and solicit the views of other Government agencies 
at the Federal (Environmental Protection Agency, U.S. Department of 
Agriculture, Centers for Disease Control), state, and local levels, 
from industry, from consumer groups, and from the public generally 
about the current science relating to preventing or minimizing 
foodborne illness associated with the consumption of sprouts. The 
public meeting and period for submission of written comments are 
intended to provide that opportunity. FDA requests that comments 
presented at the public meeting or otherwise communicated to the agency 
focus on the questions set out in section II of this document.

II. Questions

    1. What concepts or underlying principles should guide efforts to 
improve the safety of sprouts?
    2. Which practices primarily contribute to the contamination with 
harmful pathogens of seeds used for sprouting? Which intervention 
strategies can help prevent, reduce, or control this contamination of 
seeds used for sprouting? Where appropriate, identify barriers to 
adopting effective preventive controls for this contamination, and, if 
possible, suggest mechanisms to overcome these barriers.
    3. Which practices primarily contribute to the contamination with 
harmful pathogens of sprouts? Which intervention strategies can help 
prevent, reduce, or control the contamination of sprouts? Where 
appropriate, identify barriers to adopting effective preventive 
controls for this contamination, and, if possible, suggest mechanisms 
to overcome these barriers.
    4. Do the preventive controls recommended in FDA's sprout guidances 
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://vm.cfsan.fda.gov/dms/sprougd1.html and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://vm.cfsan.fda.gov/dms/sprougd2.html
) need to be expanded or otherwise revised? If yes, 
please describe generally the areas that need expansion or other 
revision.
    4. Although FDA's current recommendations address practices by all 
parties, efforts to promote adoption of effective preventive controls 
have focused largely on sprouting facilities. What can or should be 
done to increase the involvement of producers of seeds for sprouting 
and seed distributors to ensure the safety of sprouts?
    5. Is a regulation likely to be an effective means of achieving the 
goal of minimizing foodborne illness associated with the consumption of 
sprouts? If not, what is likely to be an effective approach?
    6. How can progress toward the overarching goal (to minimize 
foodborne illness associated with sprout consumption) be effectively 
measured?
    7. There is broad variation within the seed and sprout industry, 
including variations in size of establishments, the types of seeds and 
sprouts produced, the practices used in production, and, possibly, 
variations in the vulnerability of a particular type of seed or sprout 
to microbial hazards or in the effectiveness of particular 
interventions. How, if at all, should the actions to improve the safety 
of seeds for sprouting be structured to take into account such 
variation? For example, should there be different sets of interventions 
for identifiable segments of the seed

[[Page 20854]]

industry? Similarly, how, if at all, should the actions to improve the 
safety of sprouts be structured to take into account such variation? 
For example, should there be different sets of interventions for 
identifiable segments of the sprouts industry? If yes, please describe.
    8. Are there existing food safety systems or standards (such as 
international standards) that FDA should consider as part of the 
agency's efforts to minimize foodborne illness associated with the 
consumption of sprouts? Please identify these systems or standards and 
explain how their consideration might contribute to this effort.

III. Registration and Requests for Oral Presentations

    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 before the 
meeting. Registration will be accepted on a first-come basis; 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. In addition, 
early registration 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 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. 
Transcripts of the meeting may be requested in writing 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: April 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8103 Filed 4-19-05; 2:04 pm]

BILLING CODE 4160-01-S