[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Notices]
[Pages 8750-8756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-891]


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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

[[Page 8751]]

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: <a href="/cdn-cgi/l/email-protection#632a100201060f0f063c2b0c14061023041102074d161007024d040c15"><span class="__cf_email__" data-cfemail="8bc2f8eae9eee7e7eed4c3e4fceef8cbecf9eaefa5fef8efeaa5ece4fd">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#327b415350575e5e576d7a5d45574172554053561c474156531c555d44"><span class="__cf_email__" data-cfemail="d79ea4b6b5b2bbbbb2889fb8a0b2a497b0a5b6b3f9a2a4b3b6f9b0b8a1">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#baf0cfdbd4d3cedb94e3dbcedfc9fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="eba19e8a85829f8ac5b28a9f8e98ab8d8f8ac5838398c58c849d">[email protected]</span></a>.

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

[[Page 8752]]

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

[[Page 8753]]

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

[[Page 8754]]

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

[[Page 8755]]

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


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