[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://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
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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://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://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://vm.cfsan.fda.gov/~dms/sprougd1.html and
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
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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://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
Meeting Registration April 22, 2005
