[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8750-8756]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe07-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0051]
Safety of Fresh Produce; Public Hearings; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearings; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing two
public hearings concerning the safety of fresh produce. The purpose of
the hearings is for FDA to share information about recent outbreaks of
foodborne illness associated with microbial contamination of fresh
produce, and to solicit comments, data, and other scientific
information about current agricultural and manufacturing practices used
to produce, harvest, pack, cool, process, and transport fresh produce;
risk factors for contamination of fresh produce associated with these
practices; and possible measures by FDA to enhance the safety of fresh
produce.
DATES: The first public hearing will be held on March 20, 2007, from 9
a.m. to
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5 p.m. The second public hearing will be held on April 13, 2007, from 9
a.m. to 5 p.m. See section V of this document for additional dates on
how to participate in the hearings. Submit written or electronic
comments (i.e., submissions other than notices of participation and the
text, comprehensive outline, or summary of an oral presentation) by
June 13, 2007.
ADDRESSES: The first public hearing will be held at the Ronald V.
Dellums Federal Building, Edward Roybal Auditorium, 1301 Clay St., 3d
floor, Oakland, CA 94612. The second public hearing will be held at the
Harvey W. Wiley Federal Building, Food and Drug Administration, Center
for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College
Park, MD, 20740-3835 (Metro stop: College Park on the Green Line).
Submit electronic notices of participation for either hearing to
http://www.cfsan.fda.gov/~comm/register.html. We encourage you to use
this method of registration, if possible. You may also submit oral or
written notices of participation by phone, by fax, or by e-mail, or
submit the written full text, comprehensive outline, or summary of any
oral presentation by fax or by e-mail to Isabelle Howes, U.S.
Department of Agriculture Graduate School, 202-314-4713, FAX: 202-479-
6801, or e-mail: Isabelle_Howes@grad.usda.gov.
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.
Instructions: All submissions and comments received must include
the agency name and docket number found in brackets in the heading of
this document. All submissions and comments received may be posted
without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see section VI in the SUPPLEMENTARY INFORMATION
section of this document.
Transcripts of the hearings will be available for review at the
Division of Dockets Management and on the Internet at http://www.fda.gov/ohrms/dockets/default.htm
approximately 30 days after the
hearing.
FOR FURTHER INFORMATION CONTACT:
To submit an oral or written notice of participation by phone, by
fax, or by e-mail, or the written full text, comprehensive outline, or
summary of any oral presentation by fax or by e-mail: Isabelle Howes,
U.S. Department of Agriculture Graduate School, 202-314-4713, FAX: 202-
479-6801, or e-mail: Isabelle_Howes@grad.usda.gov. All participants
must complete registration. Following registration, you will receive a
confirmation notice which also includes hotel and parking information.
For all other questions about the hearings or if you need special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 301-436-
1731, e-mail: Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Food Safety and Fresh Produce
FDA is responsible for ensuring the safety of all domestic and
imported fresh and fresh-cut fruits and vegetables consumed in the
United States. Fresh fruits and vegetables are those that are likely to
be sold to consumers in an unprocessed or minimally processed (i.e.,
raw) form. Fresh fruits and vegetables may be intact and whole, such as
whole apples, or cut in the act of harvest, such as heads of lettuce
and bunches of broccoli. As used in this document, the term ``fresh-cut
produce'' refers to minimally processed fruits and vegetables that have
been altered in form by peeling, slicing, chopping, shredding, coring,
or trimming, with or without washing or other treatment, prior to being
packaged for use by the consumer or retail establishment. Examples of
fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes,
peeled baby carrots, broccoli florets, and cut melons. Fresh-cut
produce does not require additional preparation, processing, or cooking
before consumption, with the possible exception of washing or the
addition of salad dressing or seasoning. In this document, we use the
term ``fresh produce'' to describe all fresh and fresh-cut fruits and
vegetables consumed in the United States.
Because most fresh produce is grown in a natural environment, it is
vulnerable to contamination with pathogens (i.e., bacteria or other
organisms that can cause disease). Factors that may affect the
occurrence of such contamination include agricultural and/or processing
water quality, the use of manure as fertilizer, the presence of wild or
domestic animals in or near fields or packing areas, worker health and
hygiene, environmental conditions, production activities, and equipment
and facility sanitation. Consequently, the manner in which fresh
produce is grown, harvested, packed, processed, transported,
distributed, and prepared is crucial to minimizing the risk of
microbial contamination. (We use the term ``microbial contamination''
to refer to contamination with any microorganism.)
Data reported to the U.S. Centers for Disease Control and
Prevention (CDC) indicate that between 1973 and 1997 reported outbreaks
of foodborne illness in the United States associated with fresh produce
increased in absolute numbers and as a proportion of all reported
foodborne outbreaks (Ref. 1). (By ``outbreak,'' we mean the occurrence
of two or more cases of a similar illness resulting from the ingestion
of a common food.) Unpublished data compiled by FDA indicate that from
1996 to 2006 there were approximately 72 reported outbreaks of
foodborne illness associated with approximately 20 fresh produce
commodities. Of this total, 12 outbreaks were associated with tomatoes,
11 outbreaks were associated with melons, and 24 outbreaks were
associated with leafy greens such as lettuce and spinach (Ref. 2).
These outbreaks involved a number of pathogens, including Escherichia
coli (E. coli) O157:H7 and Salmonella species, and both domestic and
imported produce. These totals include only those outbreaks in which
our investigation has indicated that the contamination of the produce
was not a result of exposure to an infected food handler or other
unsafe food handling practice at the place of preparation and
consumption (i.e., home or restaurant).
When there is an outbreak of foodborne illness, we work with
Federal, State, and local agencies to identify the source of the
outbreak and minimize the public health impact. For example, on
September 14, 2006, we issued a news release alerting consumers about
an outbreak of E. coli O157:H7 in multiple States and advising the
public not to eat bagged fresh spinach because it had been implicated
in the outbreak (Ref. 3). We continued to issue updated press releases
for approximately four weeks. During the course of the outbreak,
approximately 200 illnesses were reported to the CDC, including more
than 30 cases of hemolytic uremic syndrome (HUS, a condition occurring
mainly in children that can result in kidney failure), more than 100
hospitalizations, and 3 deaths (Ref. 4). In addition to working to
identify the food involved in the outbreak, we worked with others to
trace the source of the implicated
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product to packing, cooling and processing facilities involved and to
the farm to identify practices or conditions that may have contributed
to the contamination of the produce.
One challenge faced by public health officials during an outbreak
is to quickly identify through traceback the sources of contamination.
FDA's regulations require the establishment and maintenance of records
by persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States (21 CFR 1.326-
1.368). Such records allow for the identification of the immediate
previous sources and immediate subsequent recipients of food, and
thereby help FDA and other authorities determine the source and cause
of the event. Farms and restaurants are excluded from these
requirements. Traceback can be particularly problematic when fresh
produce is involved.
Eating fruits and vegetables is an important part of a healthy diet
(Ref. 5). We place a high priority on identifying and implementing
measures that can reduce the incidence of foodborne illness associated
with fresh produce.
B. Guidance Documents and Letters Issued by FDA to Enhance the Safety
of Fresh Produce
In 1998, FDA issued guidance to industry entitled ``Guide to
Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (GAPs/GMPs Guide) (Ref. 6). This guide recommends good
agricultural practices (GAPs) and good manufacturing practices (GMPs)
that growers, packers, and shippers can undertake to address common
risk factors in their operations and thereby minimize food safety
hazards potentially associated with fresh produce. Implementation of
risk reduction measures is critical; as the GAPs/GMPs Guide notes,
current technologies cannot eliminate all potential food safety hazards
associated with fresh produce that will be eaten raw.
On February 5, 2004, FDA issued a letter to firms that grow, pack,
or ship fresh lettuce and fresh tomatoes, expressing concern regarding
outbreaks of foodborne illness associated with the consumption of fresh
lettuce and fresh tomatoes, and recommending actions to enhance the
safety of these products (Ref. 7). On November 4, 2005, FDA issued a
second letter to firms that grow, pack, process or ship fresh and
fresh-cut lettuce, reiterating concerns about continuing outbreaks
(Ref. 8). In the November 2005 letter, FDA strongly encouraged
applicable firms to review their current operations in light of the
GAPs\GMPs Guide, as well as other available information regarding the
reduction or elimination of pathogens on fresh produce. FDA encouraged
firms to consider modifying their operations to ensure that they were
taking the appropriate measures to provide a safe product to the
consumer. FDA recommended that firms from the farm level through the
distribution level undertake these steps.
On March 1, 2006, FDA issued a draft entitled ``Guide to Minimize
Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the
Fresh-cut Guide) (Ref. 9). The draft Fresh-cut Guide is intended to be
used in conjunction with the GAPs/GMPs Guide, which covers stages prior
to fresh-cut processing, with the current GMPs in part 110 (21 CFR part
110), which contain food safety practices applicable to processors who
manufacture, process, pack, or hold processed food, and with the FDA
Food Code (Ref. 10), which focuses on activities at subsequent stages,
such as retail. The FDA Food Code gives State and local governments a
scientifically sound technical and legal basis for regulating the
retail and food service segment of the industry (restaurants and
grocery stores and institutions such as nursing homes). State, local,
tribal, and Federal regulators use the FDA Food Code as a model to
develop or update their own food safety rules and to be consistent with
national food regulatory policy. (For more information on the FDA Food
Code, see http://www.cfsan.fda.gov/~dms/foodcode.html.) FDA is
currently working to finalize the Fresh-cut Guide.
C. Produce Safety Action Plan
In October 2004, FDA issued the ``Produce Safety from Production to
Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated
with Fresh Produce Consumption'' or Produce Safety Action Plan (PSAP)
(Ref. 11). The PSAP expands on the areas covered by the GAPs/GMPs Guide
for farms and packing, to extend to all parts of the food supply chain
from farm through retail or consumer preparation and consumption. The
PSAP does not 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. The PSAP
has four main objectives which are to: (1) Prevent contamination of
fresh produce with pathogens; (2) minimize the public health impact
when contamination of fresh produce occurs; (3) improve communication
with producers, packers, processors, transporters, distributors,
preparers, consumers, and other government entities about the safety of
fresh produce; and (4) facilitate and support research relevant to the
contamination of fresh produce. For each objective, the PSAP identifies
steps or actions that could contribute to the achievement of that
objective. The PSAP has measurable goals and outcomes, and several
steps outlined in the PSAP are already in progress or have been
completed. For example, we issued the draft Fresh-cut Guide as part of
the PSAP objective regarding prevention of contamination.
D. Partnerships and Collaborations
Because following the GAPs/GMPs Guide is voluntary, FDA and food
safety partners in the public and private sectors have stressed
education and outreach to industry to promote adoption of the guidance.
Buyer requirements that producers and other suppliers provide self- or
third-party audit verification that they are following the GAPs/GMPs
Guide have further promoted adoption of the guidance. We have worked
with the fresh produce industry since the release of the GAPs/GMPs
Guide to promote its recommendations and to advance the scientific
knowledge applicable to enhancing the safety of fresh produce. For
example, in conjunction with the PSAP, we have provided technical
assistance to industry in developing several commodity specific
guidelines that cover the entire supply chain. Commodity-specific
industry guidelines exist for three foods: Melons, lettuce and leafy
greens, and tomatoes (see Refs. 12, 13, and 14). An additional industry
guideline on green onions and herbs is in progress. Between 1996 and
2006, these commodities together accounted for approximately 80 percent
of the foodborne outbreaks associated with produce (Ref. 2).
In August 2006 we launched the ``Lettuce and Leafy Greens
Initiative,'' which involved assessments of practices and conditions at
select farms and facilities in California. The initiative, conducted in
collaboration with the California Department of Health Services and the
California Department of Food and Agriculture, is intended to be a
multi-year effort and may be a model for other initiatives in the
future.
E. Other Food Safety Measures
The provisions in part 110 (Current Good Manufacturing Practice In
Manufacturing, Packing, Or Holding Human Food) establish requirements
and recommendations as follows that apply in determining whether a food
is adulterated: (1) Within the meaning of
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section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 341(a)(3)), in that the food has been manufactured under
such conditions that it is unfit for food; or (2) within the meaning of
section 402(a)(4) of the act, in that the food has been prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health. Under Sec. 110.19(a), establishments engaged solely in the
harvesting, storage, or distribution of one or more raw agricultural
commodities (as defined in section 201(r) of the act (21 U.S.C. 321)),
are not subject to the requirements of part 110. However, under Sec.
110.19(b), we may issue special regulations if it is necessary to cover
these excluded operations. In addition, the GAPs/GMPs Guide recommends
that operations excluded from the provisions of part 110 consider
implementing the current GMPs required or recommended in part 110 as
appropriate.
For foods other than fresh produce, we have issued regulations
designed to enhance food safety, including safety related to microbial
pathogens (see, e.g., 21 CFR part 113, concerning thermally processed
low-acid foods packaged in hermetically sealed containers; 21 CFR part
114, concerning acidified foods; 21 CFR 15.51, concerning refrigeration
of shell eggs held for retail distribution; 21 CFR part 120, concerning
hazard analysis and critical control point (HACCP) systems for juice;
and 21 CFR part 123, concerning HACCP requirements for fish and fishery
products). Some FDA regulations to enhance the safety of particular
food products (e.g., the HACCP requirements in 21 CFR part 120 for
juice and in 21 CFR part 123 for fish and fishery products) contain
training and other requirements for performing particular functions.
For some food products, we have augmented our regulations with
nonbinding guidance to assist industry in complying with the
regulations (e.g., FDA's Juice HACCP Hazards and Controls Guidance
(available at http://www.cfsan.fda.gov/~dms/guidance.html)
and Fish And Fisheries Products Hazards And Controls Guidance
(available at http://www.cfsan.fda.gov/~dms/guidance.html)).
F. Next Steps
We believe that the measures outlined in the PSAP, the GAPs/GMPs
Guide, and other public and private sector actions, when implemented,
have or can be effective in reducing the risk of microbial
contamination of fresh produce. In particular, the GAPs/GMPs Guide has
been used as a basis for a number of food safety programs, both in the
United States and internationally. However, the fact that outbreaks of
foodborne illness associated with fresh produce continue to occur
supports a close examination of the extent to which these measures have
been implemented; whether they have been effective, if implemented
properly; and what additional or different interventions might be
appropriate to reduce the risk of future outbreaks. As a next step, we
intend to hold two public hearings regarding the safety of fresh
produce. The purpose and scope of the hearings, each of which will be
governed by part 15 (21 CFR part 15) of FDA's regulations, are
described in section II of this document.
II. Purpose and Scope of the Hearings
We want to share information about recent outbreaks of foodborne
illness associated with microbial contamination of fresh produce, and
to invite comments, data, and other scientific information about:
Current agricultural and manufacturing practices used to produce,
harvest, pack, cool, process, and transport fresh produce; risk factors
for contamination of fresh produce associated with these practices; and
possible measures by FDA to enhance the safety of fresh produce.
This notice describes the scope of the hearings. We invite
information and comment on the issues and questions in section III of
this document. If you are interested in these hearings or this subject,
you may address as many of the following questions as you wish. We do
not expect you to address all questions. When possible, please provide
scientific information and data in support of your comments. In
addition, to the extent possible, please provide as specific
information as is feasible about the estimated costs and benefits
associated with your responses (e.g., the costs and benefits of current
practices and/or the cost and benefits of any recommendations you may
make).
III. Issues and Questions for Discussion
Issue 1: In the supply chain for fresh produce (e.g., farms,
packing houses, cooling facilities, and fresh-cut processing
facilities), various factors can contribute to the risk of microbial
contamination of fresh produce. We request information to enable us to
identify and understand such factors more fully.
Question 1. For each stage in the supply chain, and for each
industry sector, what are the risks or practices that could lead to
microbial contamination of fresh produce?
Question 2. How can or should current practices be changed to
reduce the risk of contamination?
Question 3. For each stage in the supply chain, and for each
industry sector, what current practices (including, for example,
following the GAPs/GMPs Guide) reduce the risk of microbial
contamination of fresh produce? What data are available to support a
conclusion that the risk of such contamination is lower than it would
be without the practice in place?
Question 4. Is fresh produce, or inputs such as agricultural water,
sampled and tested for pathogens or indicator organisms at any stage of
the supply chain? If yes, please describe the sampling and testing
done.
Issue 2: As described more fully in sections I.B through I.E of
this document, we already have implemented several measures to enhance
the safety of fresh produce and other foods within FDA's jurisdiction.
Question 5. Beyond the Federal actions described in sections I.B.
through I.E, what new Federal actions, if any, are needed to enhance
the safety of fresh produce? On what aspects of the produce supply
chain should the measures focus?
Question 6. In identifying possible Federal interventions or
actions, to what extent can or should we take into account the wide
variation within the fresh produce industry with respect to, e.g., the
size and type of establishments, the nature of the commodity produced,
the practices used in production, and the vulnerability of particular
commodities to contamination? To what extent should such measures apply
to specific products, sectors of the industry, regions, or businesses?
For example, is there a need for special treatment for different
commodity groups?
Issue 3: Traceback can be problematic when unpackaged fresh produce
is involved in an outbreak, especially for products which may undergo
several packing and repacking steps in the supply chain with multiple
opportunities for commingling. Even with respect to packaged and
labeled products, traceback is difficult if there are insufficient
records to identify the specific farm, field, or block of origin; if
the records lack sufficient specificity about where the fresh produce
went after leaving the packing or processing facility; or if there are
discrepancies between records of incoming and outgoing product.
Question 7. What types of records and other information, from what
types of
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facilities, are or would be most useful in facilitating traceback
efforts?
Issue 4: Written food safety plans, sanitation standard operating
procedures (SSOPs), and monitoring records can serve as useful tools
for both industry and regulators. Such records can assist operators in
conducting operations in a manner that could enhance the safety of
fresh produce. For growers, an assessment of factors such as the field
environment and agricultural inputs could contribute to the development
of written food safety plans and SSOPs, and also could help to
determine which factors should be monitored and the frequency of
monitoring. (In the following questions we use the term ``assessment''
when referring to an evaluation conducted by, or on behalf of, a grower
or operator to identify measures to enhance food safety.)
Written food safety plans, SSOPs, and monitoring records also can
assist regulators in verifying that certain practices are being
followed consistently and properly over time. Onsite inspections,
either alone, or in conjunction with records review, are another
approach to such verification. (We use the term ``inspection'' when
referring to an evaluation conducted by, or on behalf of, a regulator
to evaluate compliance and the term ``audit'' to refer to a self- or
third-party evaluation of whether operations adhere to, for example,
voluntary guidelines or written food safety plans or SSOPs developed by
the grower, operator, or buyer.)
Question 8. Are written food safety plans, written SSOPs, periodic
assessments, training, and/or the establishment and maintenance of
records useful for risk identification and risk mitigation or
management purposes? If yes, to what extent are these practices in
place, and in what sectors of the industry?
Issue 5: As noted in section II.D of this document, some buyers
require that producers and other suppliers provide self- or third-party
audit verification that they are following the GAPs/GMPs Guide.
However, the extent to which these verifications reflect adherence to
the guidance is not well-established.
Question 9. How should adherence to the GAPs/GMPs Guide or new
produce safety guidance(s) be measured and verified by the grower or
operator, government regulators, or third-party auditors, in the event
of any new recommended Federal action or in the event you are not
recommending any new Federal action?
Question 10. If you are recommending any new Federal measures,
please describe how they might affect certain small businesses, such as
roadside stands, farm gate operations, farmers' markets, or other small
businesses involved in direct sales.
IV. Notice of Hearings Under 21 CFR Part 15
By delegation from the Commissioner of Food and Drugs (the
Commissioner) (Staff Manual Guide 1420.21, section 1(b)), the Associate
Commissioner for Policy and Planning finds that it is in the public
interest to permit persons to present information and views at a public
hearing regarding the safety of fresh produce and is announcing that
the public hearings will be held in accordance with part 15. The
presiding officer will be the Commissioner or his designee. The
presiding officer will be accompanied by a panel of FDA employees with
relevant expertise.
Persons who wish to participate in either hearing (either by making
a presentation or as a member of the audience) must file a notice of
participation (see ADDRESSES, DATES, FOR FURTHER INFORMATION CONTACT,
and ``How to Participate in the Hearings'' in section V of this
document). By delegation from the Commissioner (Staff Manual Guide
1420.21, section 1(b)), the Associate Commissioner for Policy and
Planning has determined under Sec. 15.20(c) that advance submissions
of oral presentations are necessary for the panel to formulate useful
questions to be posed at the hearings under Sec. 15.30(e), and that
the submission of a comprehensive outline or summary is an acceptable
alternative to the submission of the full text of the oral
presentation. Because we anticipate attendance at the hearings to be
high, we request that individuals and organizations with common
interests consolidate their requests for oral presentation and request
time for a joint presentation through a single representative. After
reviewing the notices of participation and accompanying information, we
will schedule each oral presentation and notify each participant of the
time allotted to the presenter and the approximate time that the
presentation is scheduled to begin. If time permits, we may allow
interested persons who attend one or both hearings but did not submit a
notice of participation in advance to make an oral presentation at the
conclusion of one or both hearings. The hearing schedules will be
available at the hearings.
After the hearings, the schedules will be placed on file in the
Division of Dockets Management (see ADDRESSES) under the docket number
listed in brackets in the heading of this notice.
To ensure timely handling of any mailed notices of participation,
presentations, or comments, any outer envelope should be clearly marked
with the docket number listed in brackets in the heading of this notice
along with the statement ``Safety of Fresh Produce; Public Hearing.''
Under Sec. 15.30(f), the hearings are informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
the procedures and limitations in Sec. 10.206, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearings will be transcribed as
stipulated in Sec. 15.30(b). The transcript will be available on the
Internet at http://www.fda.gov/ohrms/dockets/default.htm, and orders
for copies of the transcript can be placed at the hearing or through
the Division of Dockets Management (see ADDRESSES).
Any handicapped persons requiring special accommodations to attend
the hearings should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearings, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec. Sec.
10.19 and 15.30(h). In particular, Sec. 15.21(a) states that the
notice of hearing will provide persons an opportunity to file a written
notice of participation with the Division of Dockets Management within
a specified period of time. If the public interest requires, e.g., if a
hearing is to be conducted within a short period of time, the notice
may name a specific FDA employee and telephone number to whom an oral
notice of participation may be given. If the public interest requires,
the notice may also provide for submitting notices of participation at
the time of the hearing. In this document, the conditions for the
hearings specify that notices of participation be submitted
electronically to an agency Internet site, to a contact person (outside
of FDA) who will accept notices of participation
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by mail, telephone, fax, or e-mail, or in person on the day of the
hearing (as space permits). We are using these procedures for
submitting notices of participation, rather than provide for the
submission of notices of participation to the Division of Dockets
Management, because the hearing is to be conducted within a short
period of time and these procedures are more efficient. In addition,
these procedures provide more flexibility to persons who wish to
participate in the hearings than would be provided if participants were
required to submit the notice of participation in writing to the
Division of Dockets Management. By delegation from the Commissioner
(Staff Manual Guide 1420.21, section 1(f)(2)(i)), the Associate
Commissioner for Policy and Planning finds under Sec. 10.19 that no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with law if notices of
participation are submitted by the procedures listed in this notice
rather than to the Division of Dockets Management.
V. How to Participate in the Hearings
Registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. The notice of participation may be submitted
electronically (see ADDRESSES). The notice of participation also may be
submitted orally, by fax, or by e-mail (see ADDRESSES and FOR FURTHER
INFORMATION CONTACT). We encourage you to submit your notice of
participation electronically. A single copy of any notice of
participation is sufficient, except that any person who wishes to
participate in both hearings must submit a separate notice of
participation for each hearing.
The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations will be limited to the questions and
subject matter identified in section III of this document, and,
depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation.
Persons who wish to request an opportunity to make an oral
presentation at the March 20, 2007, public hearing must submit a notice
of participation (register) by March 2, 2007. All other persons wishing
to register to attend the March 20, 2007, public hearing must submit a
notice of participation by March 12, 2007. Persons who request an
opportunity to make an oral presentation at the March 20, 2007, public
hearing also must submit either the full text of the oral presentation,
or a comprehensive outline or summary of the oral presentation, by
March 12, 2007. Persons requiring special accommodations due to a
disability must register by March 6, 2007.
Persons who wish to request an opportunity to make an oral
presentation at the April 13, 2007, public hearing must submit a notice
of participation by March 23, 2007. All other persons wishing to
register to attend the April 13, 2007, public hearing must submit a
notice of participation by April 6, 2007. Persons who request an
opportunity to make an oral presentation at the second public hearing
also must submit either the full text of the oral presentation, or a
comprehensive outline or summary of the oral presentation, by April 6,
2007.
Under Sec. 15.20(c), if you request an opportunity to make an oral
presentation you must submit your presentation (either as the full text
of the presentation, or as a comprehensive outline or summary) by e-
mail or by fax. See ADDRESSES and FOR FURTHER INFORMATION CONTACT for
information on where to send your presentation.
Individuals who request an opportunity to make an oral presentation
will be notified of the scheduled time for their presentation prior to
the hearing. Depending on the number of oral presentations, we may need
to limit the time allotted for each oral presentation (e.g., 5 minutes
each). As stated earlier, we request that interested persons and groups
having similar interests consolidate their requests for oral
presentation and present them through a single representative. If you
need special accommodations due to a disability, please inform us (see
FOR FURTHER INFORMATION CONTACT).
We will also accept registration onsite; however, space is limited
and will be closed when the maximum seating capacity is reached. If
space is available, on-site registration will be accepted on a first-
come, first-served basis. Requests for an opportunity to make a
presentation from individuals or organizations that did not register to
make an oral presentation may be granted if time permits.
Persons who registered for the hearing should check in at the on-
site registration desk between 8:30 and 9 a.m. Persons who wish to
register onsite on the day of the hearing should do so at the
registration desk between 8:30 and 9 a.m. We encourage all participants
to attend the entire day. Because the hearings will be held in Federal
buildings, hearing participants must present photo identification and
plan adequate time to pass through the security system.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments in response to this
document and notice of hearings for consideration at or after the
hearings in addition to, or in place of, a request for an opportunity
to make an oral presentation (see section V of this document). Submit
two paper copies of any written comments, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in 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.
FDA is inviting public comment in writing and at the public
hearings. These comments are sought to inform FDA decisionmaking about
possible regulatory action with respect to the safety of fresh produce.
Written or electronic comments (i.e., submissions other than notices of
participation and the text, comprehensive outline, or summary of an
oral presentation) may be submitted until June 13, 2007. The
administrative record of the hearing will remain open until June 13,
2007.
VII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.
1. Sivapalasingam, S., et al. ``Fresh Produce: A Growing Cause
of Outbreaks of Foodborne Illness in the United States, 1973 through
1997,'' Journal of Food Protection 67(10): 2342-53, 2004.
2. U.S. Food and Drug Administration, 1996-2006 Produce
Outbreaks (unpublished compilation).
3. U.S. Food and Drug Administration, FDA News Release, ``FDA
Warning on Serious Foodborne E. coli O157:H7
[[Page 8756]]
Outbreak,'' P06-131, September 14, 2006, available at http://www.fda.gov/po/indexes/2006news.html.
4. U.S. Centers for Disease Control and Prevention, ``Update on
Multi-State Outbreak of E. coli O157:H7 Infections From Fresh
Spinach, October 6, 2006, available at http://www.cdc.gov/ecoli/2006/september/updates/100606.htm.
5. U.S. Department of Health and Human Services and U.S.
Department of Agriculture, ``Dietary Guidelines for Americans
2005,'' January 2005, available at http://www.healthierus.gov/dietaryguidelines/.
6. U.S. Food and Drug Administration, ``Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,''
October 26, 1998, available at http://www.cfsan.fda.gov/~dms/prodguid.html.
7. U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, Office of Plant and Dairy Foods, ``Letter to
Firms that Grow, Pack, or Ship Fresh Lettuce and Fresh Tomatoes,''
February 5, 2004, available at
http://www.cfsan.fda.gov/~dms/prodltr.html.
8. U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, Office of Plant and Dairy Foods, ``Letter to
California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-
cut Lettuce,'' November 4, 2005, available at
http://www.cfsan.fda.gov/~dms/prodltr2.html.
9. U.S. Food and Drug Administration, ``Guide to Minimize
Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,''
March 2006, available at http://www.cfsan.fda.gov/~dms/prodgui2.html
.
10. U.S. Department of Health and Human Services, Public Health
Service, Food and Drug Administration, FDA Food Code, 2005,
available at http://www.cfsan.fda.gov/~dms/foodcode.html.
11. U.S. Food and Drug Administration, ``Produce Safety from
Production to Consumption: 2004 Action Plan to Minimize Foodborne
Illness Associated With Fresh Produce Consumption,'' October 2004,
available at http://www.cfsan.fda.gov/~dms/prodpla2.html.
12. Produce Marketing Association and United Fresh Fruit and
Vegetable Association, ``Commodity Specific Food Safety Guidelines
for the Melon Supply Chain,'' November 7, 2005, available at
http://www.cfsan.fda.gov/~dms/melonsup.html or
http://www.cfsan.fda.gov/~acrobat/melonsup.pdf.
13. International Fresh-Cut Produce Association, Produce
Marketing Association, United Fresh Fruit and Vegetable Association,
Western Growers Association; Commodity Specific Food Safety
Guidelines for the Lettuce and Leafy Greens Supply Chain; April 25,
2006, available at http://www.cfsan.fda.gov/~dms/lettsup.html or
http://www.cfsan.fda.gov/~acrobat/lettsup.pdf.
14. North American Tomato Trade Work Group, ``Commodity Specific
Food Safety Guidelines for the Fresh Tomato Supply Chain, May 2006,
available at http://www.cfsan.fda.gov/~dms/tomatsup.html or
http://www.cfsan.fda.gov/~acrobat/tomatsup.pdf.
Dated: February 21, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 07-891 Filed 2-23-07; 8:45 am]
BILLING CODE 4160-01-S