[Federal Register Volume 73, Number 186 (Wednesday, September 24, 2008)]
[Notices]
[Pages 55115-55122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22430]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0513]


Product Tracing Systems for Fresh Produce; Public Meetings

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public meeting; request for comment.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing two 
public meetings regarding product tracing systems for fresh produce. 
The purpose of the meetings is to stimulate and focus a discussion 
about mechanisms to enhance product tracing systems for fresh produce 
and to improve FDA's ability to use the information in such systems to 
identify the source of contamination associated with fresh produce-
related outbreaks of foodborne illness. This discussion will help FDA 
determine what short and long term steps we should take to enhance the 
current tracing system.

DATES:  See ``How to Participate in the Meetings'' in the SUPPLEMENTARY 
INFORMATION section of this document.

ADDRESSES:  See ``How to Participate in the Meetings'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For registration, requests to make an 
oral presentation, and submission of written material for the 
presentation: Deborah Harris, EDJ Associates, Inc., 11300 Rockville 
Pike, suite 1001, Rockville, MD 20852, 240-221-4326, FAX: 301-945-4295, 
e-mail: [email protected].
    For general questions about the meeting, to request onsite parking 
for the October 16 meeting, or for special accommodations due to a 
disability: Juanita Yates, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration (HFS-009), 5100 Paint Branch 
Pkwy., College Park, MD 20740, 301-436-1731, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. How to Participate in the Meetings

    Stakeholders will have an opportunity to provide oral comments. Due 
to limited space and time, we encourage all persons who wish to attend 
one or both of the meetings, including those requesting an opportunity 
to make an oral presentation at one or both of the meetings, to 
register in advance. Depending on the number of oral presentations, we 
may need to limit the time of each oral presentation (e.g., 5 minutes 
each). If time permits FDA may grant requests for an opportunity to 
make a presentation from individuals or organizations that did not 
register in advance.
    Table 1 of this document provides information on participation in 
the meetings and on submitting comments.

                                                    Table 1.
----------------------------------------------------------------------------------------------------------------
                           Date                Address          Electronic Address        Other Information
----------------------------------------------------------------------------------------------------------------
First Public         October 16,       Harvey W. Wiley         ...................  ............................
 Meeting              2008, from 9      Federal Building,
                      a.m. to 5 p.m.    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)
----------------------------------------------------------------------------------------------------------------
  Advance            October 8, 2008   We encourage you to     http://www.cfsan.    Registration information,
   registration                         use electronic          fda.gov/             information on requests to
                                        registration if         register.html        make an oral presentation,
                                        possible.\1\                                 and written material
                                                                                     associated with an oral
                                                                                     presentation may be posted
                                                                                     without change to http://www.regulations.gov,
                                                                                     including any personal
                                                                                     information provided.
--------------------------------------
  Make a request     October 1, 2008   ......................  ...................  ............................
   for oral
   presentation
--------------------------------------
  Provide a brief    October 8, 2008   ......................  ...................  ............................
   description of
   the oral
   presentation and
   any written
   material for the
   presentation
----------------------------------------------------------------------------------------------------------------
  Request special    October 8, 2008   See FOR FURTHER         ...................  ............................
   accommodations                       INFORMATION CONTACT
   due to a
   disability
----------------------------------------------------------------------------------------------------------------
  Request onsite     October 10, 2008  See FOR FURTHER         ...................  ............................
   parking                              INFORMATION CONTACT
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½

[[Page 55116]]

 
Second Public        November 13,      Ronald V. Dellums       ...................  ............................
 Meeting              2008, from 9      Federal Building,
                      a.m. to 5 p.m.    Edward Roybal
                                        Auditorium, 1301 Clay
                                        St., 3d floor,
                                        Oakland, CA 94612
----------------------------------------------------------------------------------------------------------------
  Advance            October 30, 2008  We encourage you to     http://www.cfsan.    Registration information,
   registration                         use electronic          fda.gov/             information on requests to
                                        registration if         register.html        make an oral presentation,
                                        possible.\1\                                 and written material
                                                                                     associated with an oral
                                                                                     presentation may be posted
                                                                                     without change to http://www.regulations.gov,
                                                                                     including any personal
                                                                                     information provided.
--------------------------------------
  Make a request     October 23, 2008  ......................  ...................  ............................
   for oral
   presentation
--------------------------------------
  Provide a brief    October 30, 2008  ......................  ...................  ............................
   description of
   the oral
   presentation and
   any written
   material for the
   presentation
----------------------------------------------------------------------------------------------------------------
  Request special    October 30, 2008  See FOR FURTHER         ...................  ............................
   accommodations                       INFORMATION CONTACT
   due to a
   disability
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Submit comments      January 22, 2009  Division of Dockets     http://              All comments should be
                                        Management (HFA-305),   www.regulations.go   identified with the docket
                                        Food and Drug           v                    number found in brackets in
                                        Administration, 5630                         the heading of this
                                        Fishers Lane rm.                             document. For additional
                                        1061, Rockville, MD                          information on submitting
                                        20852                                        comments, see section IV of
                                                                                     this document.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register by mail, fax, e-mail, or phone by providing registration information (including name,
  title, firm name, address, telephone number, fax number, and e-mail address), requests to make an oral
  presentation, and written material for the presentation to the contact person for registration (see FOR
  FURTHER INFORMATION CONTACT).

II. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

III. Background

A. Introduction

    Food can become contaminated at many different steps in the farm-
to-table continuum--on the farm; in packing, processing, or 
distribution facilities; during storage or transit; at retail 
establishments; in restaurants; and in the home. In recent years, FDA 
has done a great deal to prevent both deliberate and unintentional 
contamination of food at each of these steps. FDA has worked with other 
Federal, State, local, tribal, and foreign counterpart food safety 
agencies, as well as with law enforcement agencies, intelligence-
gathering agencies, industry, and academia, to significantly strengthen 
the Nation's food safety and food defense systems across the entire 
distribution chain. This cooperative work has resulted in a greater 
awareness of potential vulnerabilities, the creation of more effective 
prevention programs, new surveillance systems, and the ability to 
respond more quickly to outbreaks of foodborne illness. (An 
``outbreak'' is the occurrence of two or more cases of a similar 
illness resulting from the ingestion of a common food.) However, 
changes in consumer preferences, changes in industry practices, and the 
rising volume of imports continue to pose significant challenges for 
the agency, particularly with respect to fresh produce. Outbreaks 
involving various types of fresh fruit and vegetables have led to 
thousands of confirmed illnesses in recent years (72 FR 8750, February 
27, 2007, and Ref. 1), and many more unconfirmed or unreported 
illnesses.
    When an outbreak of foodborne illness occurs, quick action is 
critical to prevent additional illness. The Centers for Disease Control 
and Prevention (CDC) of the U.S. Department of Health and Human 
Services, and State, local, and/or tribal health departments conduct 
epidemiologic investigations to identify the possible food(s) involved 
in an outbreak. After CDC and/or the State/local/tribal entity notify 
FDA that a specific food is implicated, FDA reviews and evaluates the 
epidemiologic data and assesses other potential causes for the outbreak 
(e.g., food worker illness, environmental contamination). Based on 
FDA's review and evaluation, an investigation to trace back the 
implicated food may be initiated to identify the source of the food 
and, potentially, of the contamination. Working with industry and with 
other domestic and, in some cases foreign, government agencies, FDA 
inspects or investigates points throughout the supply chain to 
determine where the contamination is likely to have occurred. Tracing 
food through a supply

[[Page 55117]]

chain may require us to find and examine products, packaging, and 
documentation (such as bills of lading, invoices, and other records 
maintained by the firm).
    The ability to quickly identify the source of a contaminated 
product, and the path the product traveled between production and 
consumption, is critical to responding effectively to ongoing outbreaks 
of foodborne illness. Timely and accurate information gained from an 
investigation of the source of produce implicated in an outbreak of 
foodborne illness (traceback investigation) may:
     Help limit the public health impact of a foodborne illness 
outbreak, for example, by more quickly removing the contaminated 
produce from the market;
     Enable public health authorities and the food industry to 
provide targeted and accurate information about affected food to 
consumers and, as a result, restore or enhance consumer confidence in 
produce safety; and
     Help limit the source of the problem to a particular 
region or locality so that firms or regions that are not connected to 
the contaminated food are not adversely affected by a foodborne illness 
outbreak or the investigation of an outbreak.
    In addition, the identification of sources of contaminated products 
may prevent future outbreaks by helping FDA and the food industry to 
identify and eliminate conditions that may have resulted in the food 
becoming contaminated and by helping them to understand better how the 
food became contaminated, so that the lessons learned can be used to 
prevent contamination in the future.
    When an outbreak occurs, it also is critical that we be able to act 
quickly to take steps to prevent further illness. FDA may attempt to 
document the distribution of all implicated lots of food (traceforward 
operation) once the source of an outbreak is known to ensure that all 
contaminated food in commerce is removed from the market. Traceback 
investigations and traceforward operations are components of a 
``product tracing'' system. As defined by the Codex Alimentarius 
Commission (Codex),\1\ traceability/product tracing is the ability to 
follow the movement of a food through specified stage(s) of production, 
processing, and distribution (Ref. 2).
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    \1\ The Codex Alimentarius Commission was formed in 1963 by the 
Food and Agriculture Organization and the World Health Organization 
of the United Nations to develop food standards, guidelines, and 
related texts such as codes of practice, and is recognized under the 
World Trade Organization Agreement on the Application of Sanitary 
and Phytosanitary Measures as the international standards 
organization for food safety.
---------------------------------------------------------------------------

    Traceback investigations involving fresh produce are among the most 
challenging investigations we face because the food is perishable and 
may no longer be available for testing by the time we conduct our 
investigation. In addition, fresh produce is often sold loose, without 
any packaging that would provide information about its source. Further, 
cases in which the produce was shipped, which may have provided such 
information, may also have been discarded by the time a traceback 
investigation is initiated. Industry practices, such as repacking 
produce from multiple sources, using different names for the same fresh 
produce as it travels throughout the supply chain, and not assigning 
specific identifiers to the produce, can complicate our traceback 
investigations even further.
    We have had some recent successes in quickly identifying the source 
of an outbreak, but in some situations efforts to identify the source 
of the outbreak have proven difficult or impossible. We have learned 
that we need to be able to respond to the increased size and complexity 
of the fresh produce supply chain with a traceback capacity that is 
likewise more sophisticated, effective, and efficient and that reflects 
and responds to changing production and distribution patterns.
    We are holding the public meetings to stimulate and focus a 
discussion about mechanisms to enhance product tracing systems for 
fresh produce and to improve FDA's ability to use the information in 
such systems to identify the source of contamination associated with 
fresh produce-related outbreaks of foodborne illness.

B. Information Elements Available in Current Product Tracing Systems

    A product tracing system consists of information elements provided 
by parties in the supply chain. In general, this information is 
available in the form of records that parties in the supply chain 
establish and maintain apart from the produce. Some of this information 
may also be present on packaged food or on shipping cases of food items 
such as loose produce; some information applied to loose produce (e.g., 
on a sticker) may also provide information related to product tracing.
    In the context of a foodborne illness outbreak, the information 
available through a product tracing system should enable an interested 
party (such as a party in the supply chain or a public health agency 
conducting a traceback investigation) to identify, at any specific 
stage of the supply chain, where the fresh produce came from, where the 
fresh produce was or is (e.g., in situations where a party in the 
supply chain has the fresh produce in its possession), where the fresh 
produce went, and who transported the fresh produce. This is commonly 
known as a ``one up/one down'' or ``one step back/one step forward'' 
system. In general, records that are part of such a system fall into 
one of two categories: Paper-based, human-readable records; or 
technology-based records with automated data capture (e.g., via bar 
codes or radiofrequency identification (RFID)), which may or may not 
also be human-readable.
    To facilitate product tracing, FDA's regulations, at 21 CFR part 1, 
subpart J, ``Establishment, Maintenance, and Availability of Records,'' 
impose ``one up/one down'' recordkeeping requirements on certain 
persons who manufacture, process, pack, transport, distribute, receive, 
hold, or import food in the United States. The regulations identify the 
information that must be established and maintained, how long it must 
be maintained, and how quickly it must be available to FDA. This 
information includes where the food product came from and where it 
went. A detailed discussion of those requirements is beyond the scope 
of this document, which does not address compliance with the 
recordkeeping regulations.\2\
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    \2\ For more information on the recordkeeping regulations, see 
``What You Need to Know About Establishment and Maintenance of 
Records'' (Ref. 3) and ``Questions and Answers Regarding 
Establishment and Maintenance of Records'' (Ref. 4).
---------------------------------------------------------------------------

    Other product information, relevant to some traceback 
investigations, is available on the product label of packaged foods. 
For example, section 403(e)(1) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 343(e)) provides that a food in package form 
is misbranded unless it bears a label containing the name and place of 
business of the manufacturer, packer, or distributor. As another 
example, section 403(i)(1) of the act provides that a food is 
misbranded unless its label bears the common or usual name of the food, 
if there is one. Our regulations implementing these provisions are in 
part 101 (21 CFR part 101). However, under our labeling regulations, 
the term ``package'' does not include shipping containers or wrappings 
used solely for the transportation of such commodities in bulk or in 
quantity to manufacturers, packers, processors, or wholesale or retail 
distributors (see 21 CFR 1.20(a)).

[[Page 55118]]

C. Structural and Geographic Characteristics of the Fresh Produce 
Industry Relevant to Product Tracing Systems

    The fresh produce industry is particularly diverse, both 
structurally and geographically (Ref. 6). Structurally, the industry 
varies not only by commodity, region, and season, but also by 
distributor and retailer. For example, as discussed later in this 
section, parties in the supply chain may use one or more suppliers for 
the same type of fresh produce depending on factors including growing 
season, demand, and the variability of different harvests in different 
locations.
    Geographically, more than 55 billion pounds of fresh produce are 
grown within the United States annually, and more than 26 billion 
pounds of fresh produce are imported into the United States every year 
from 58 countries (Ref. 7). These 81 billion pounds of produce often 
travel hundreds or thousands of miles on the way to consumers (usually 
in shipments of 10,000 pounds or much less), and change hands several 
times between different points in the complex supply chain (Ref. 7). 
The nature and complexity of the global produce market raise special 
challenges for public health agencies, and even those within the 
industry, to be able to trace the path of a particular product 
throughout the supply chain.

D. Challenges Associated with Traceback Investigations of Fresh Produce

    The supply chain for a given type of fresh produce may be very 
complex. For example, several growers might supply their produce to a 
packer or distributor, and there may be multiple distributors who 
receive the product before its sale to or use by the ultimate consumer. 
Growers may send their produce to several packers or distributors, and 
suppliers may obtain produce from several packers or distributors as 
well as directly from growers. Parties in the supply chain may be 
within the United States or abroad; thus, produce might be imported 
into or exported from any point in the supply chain one or more times. 
Other parties in a food supply chain may include processors of fresh 
produce, who may chill it, cut it into smaller pieces, or combine 
pieces of fresh produce with other foods to make another food product 
(such as using lettuce to make a salad). Contamination can occur at 
almost any point in the fresh produce supply chain.
    In some fresh produce supply chains, produce from multiple sources 
may be combined or commingled during packing or processing operations. 
This practice can complicate or even frustrate efforts to trace fresh 
produce throughout the supply chain. For example, a packing firm may 
buy a particular type of vegetable from multiple farms, and then sort 
the vegetables by size, color, quality, or some other attribute before 
packing into containers. As another example, a large truck may collect 
loose produce from multiple farms and then deliver the collected loose 
produce to a single processor or distributor. Even if we could trace a 
contaminated product back to the processor or distributor, or, in the 
second example, back to the packing firm, the commingling of loose 
produce before it reaches the processor or distributor or at the 
packing firm makes it difficult or impossible to distinguish which farm 
is the source of the contaminated produce. The complexity increases if 
the truck delivers the loose produce to more than one processor or 
distributor.
    An additional challenge associated with a traceback investigation 
for fresh produce is that the produce may not always retain the same 
description as it moves through the supply chain. For example, one 
party in the supply chain may describe its fresh produce as ``red round 
tomatoes,'' while the next party in the supply chain may describe the 
same fresh produce as ``cooker tomatoes.'' Different descriptions for 
the same produce can make it very difficult or impossible to determine 
whether two records refer to the same or different products or 
shipments.
    Another challenge associated with a traceback investigation for 
fresh produce is that there may be no identifier on the produce, its 
package, or its case, and in associated records. Moreover, there 
currently is no industry-wide or sector-wide standardization of the 
information captured in the documentation. This lack of standardization 
makes it difficult and time-consuming to cross-reference information 
currently available in product tracing systems.

E. How Has Product Tracing Information Available in Records and on 
Product Packages/Containers Helped Us During Traceback Investigations?

    In the following paragraphs, we describe how we used product 
tracing information to conduct two recent traceback investigations--one 
involving a nonperishable packaged food, and one involving a perishable 
packaged food. The information available to us included information 
available in records established and maintained by parties in the 
supply chain and information available on packages or containers of the 
packaged food.
     In February 2007, CDC notified FDA of a multi-State 
outbreak of Salmonella Tennessee infections associated with the 
consumption of peanut butter. Peanut butter is a nonperishable packaged 
food, sold in jars. Consumers who became ill had open jars of peanut 
butter available for testing. Investigators were able to test samples 
of peanut butter taken from the jars and confirm the presence of 
Salmonella Tennessee in the peanut butter. Investigators were able to 
identify the manufacturer through information required to be on the 
label of the jars (Sec.  101.5(a)) and through a product code the 
manufacturer had voluntarily placed on the jars. This information made 
it possible for FDA to visit the manufacturing facility the day after 
we learned of the outbreak from CDC. Investigators were able to use the 
product code to look in the manufacturing facility for unopened jars of 
peanut butter manufactured at the same time as the jars available from 
consumers. Investigators took samples of peanut butter from these 
unopened jars and confirmed the presence of Salmonella Tennessee in 
those samples. Investigators uncovered conditions at the manufacturer's 
facility that were likely to have caused the contamination and obtained 
a positive environmental sample so there was no need to further trace 
the peanuts back to the farm. Our traceback investigation was 
facilitated because the implicated food was a nonperishable, packaged 
food that was available to investigators and contained information 
about the source of the implicated food on the product container.
     In September 2006, CDC informed FDA of a multi-State 
outbreak of illnesses associated with the consumption of fresh spinach 
contaminated with E. coli O157:H7. Fresh spinach is a perishable food 
that may not remain in consumers' homes after consumers become ill and 
CDC finds an association between the illness and the food. However, in 
this situation the spinach was sold in a package. The traceback 
investigation was facilitated because several consumers who became ill 
still had packages of fresh spinach in their refrigerators. As with the 
peanut butter, investigators were able to identify the processor 
through information required to be on the label of the packaged spinach 
(Sec.  101.5(a)) and through a product code the processor had 
voluntarily placed on the package. By looking at the processor's 
records, the investigators were able to identify the implicated farms 
associated with the

[[Page 55119]]

identified production lot of bagged spinach. This traceback 
investigation was more complex than the investigation for the peanut 
butter, because it required traceback beyond the processor to the 
farms. However, as with the peanut butter, the traceback investigation 
was greatly facilitated by the information on the label of the packaged 
food and on the package itself.

F. Industry Product Tracing Systems That Are in Use or Under 
Development in the United States

1. Commodity-Specific Efforts
    Various recordkeeping and other practices designed to enhance 
product tracing systems are already carried out by industry within the 
food supply chain. For instance, to better monitor food safety 
practices of growers, the California cantaloupe industry has 
incorporated product tracing requirements that involve maintaining 
information such as packing date, field, and packing crew as part of 
their State marketing order (Ref. 9).
    Similarly, the California Tomato Farmers cooperative has instituted 
documentation requirements in its membership agreement with growers to 
facilitate one up/one down tracking and product tracing. The 
documentation of packed tomatoes must include information about the 
source (i.e., grower, production location, lot identification, 
personnel/crew involved in the harvest of the product) and about the 
customer receiving the product. A system to track and trace tomatoes 
back to supply source and forward to customers must be developed and 
tested annually (Ref. 10).
    Stakeholders have developed commodity-specific food safety 
guidelines for the entire supply chain for three commodities: Melons 
(Ref. 11), tomatoes (Ref. 8), and lettuce and leafy greens (Ref. 12).
2. Buyer-Led Initiatives
    Large food retailers, such as supermarket chains, have become more 
active in ensuring the safety of the food products they purchase. One 
example of this is the increasing use of independent third-party food 
safety audits of grower and shipper operations to verify compliance 
with good agricultural and manufacturing practices. These practices 
generally include requirements that the grower or shipper maintain 
records that facilitate the tracing of product produced, handled, or 
processed in order to pass an audit.
    For example, in February 2008, Wal-Mart, Inc., became the first 
U.S. grocery chain to require suppliers of its private label and other 
food products to have their factories certified against one of the 
internationally-recognized Global Food Safety Initiative (GFSI) 
standards (Ref. 13). The GFSI standard for traceability requires the 
supplier to develop and maintain appropriate procedures and systems to 
ensure (1) identification of any out-sourced product, ingredient, or 
service; (2) complete records of batches of in-process or final product 
and packaging throughout the production process; and (3) record of 
purchaser and delivery destination for all product supplied (Ref. 14).
3. Produce Traceability Initiative (PTI)
    In October 2007, the Produce Marketing Association (PMA), the 
United Fresh Produce Association (UFPA), and the Canadian Produce 
Marketing Association (CPMA) initiated the joint PTI (Ref. 15). The PTI 
now includes more than 50 companies, including distributors, grower-
shippers, and retailers. A principal objective of the PTI is to drive 
adoption of consistent ``traceability best practices'' throughout the 
produce supply chain from ``field to fork.'' In pursuing the goal of 
broad adoption of tracking and product tracing standards and practices, 
the PTI has established a timeline for a series of milestones for 
recording, tracking, and product tracing data on produce shipments. 
These milestones include establishing company prefixes; establishing an 
identification number for location; assigning global trade item numbers 
(GTINs) to produce cases; showing GTINs, lot numbers, and packing/
harvesting dates on each case; encoding this information in bar codes; 
and reading and storing the information at each point in the supply 
chain. The PTI also calls for tracking and product tracing standards to 
be adopted at the case level initially, followed by standards for item-
level coding (Refs. 5 and 16).

G. International Product Tracing Systems

    Some countries have mandatory product tracing systems in place in 
various forms, although these systems are more prevalent with respect 
to animal identification than for food in general. The European Union 
(EU), in addition to having a mandatory product tracing system for 
animals, also requires a product tracing system for all food and feed 
businesses. Specifically, the EU requires all food and feed to be 
traceable ``one step forward and one step back'' in EU member states. 
Food and feed business operators must be able to document where a 
particular food or feed product came from and where it is going next. 
Specifically, they must be able to document the names and addresses of 
suppliers and customers, as well as the nature of the product and date 
of delivery. They are also encouraged to keep information on the volume 
and quantity of a product; the batch number, if one exists; and a more 
detailed description of the product, such as whether it is fresh or 
processed. Food and feed business operators must also have systems and 
procedures that allow them to provide this information to the competent 
authorities on demand. In addition to these general requirements, 
sector-specific requirements apply to certain categories of food 
products (fruit and vegetables, beef, fish, honey, olive oil) (Refs. 17 
through 20). In 2007, the EU began a 4-year study to develop, test, and 
evaluate two full pilot product tracing systems--one for the tomato 
food chain and the other for the feed/dairy chain (Ref. 21).
    In 2006, Codex established principles for tracing food through 
production and distribution processes (Ref. 2). The Codex principles 
are intended to assist government authorities in utilizing product 
tracing as a tool within their food inspection and certification 
system.
    Certain private international standard setting organizations have 
also developed principles and other guidelines on product tracing 
systems for use by industry. For example, in 2007 the International 
Standards Organization (ISO) issued ISO 22005:2007, which provides 
general principles and basic requirements for designing and 
implementing a product tracing system along a food processor's supply 
chain.\3\ Another example is the GS1 Global Traceability Standard (Ref. 
22), which is being used by the PMA, CPMA, UFPA, and other associations 
involved in the PTI.
---------------------------------------------------------------------------

    \3\ ISO 22005:2007. ``Traceability in the feed and food chain--
General principles and basic requirements for system design and 
implementation.'' July 2007. Available for purchase at http://webstore.ansi.org.
---------------------------------------------------------------------------

H. Actions Suggested by Stakeholders

    Some consumer advocacy groups have asked us to develop and 
implement emergency regulations that would require source tracing for 
produce (farm-to-table); written food safety plans for farmers, 
processors, and packinghouses; and tighter controls on repacking (Ref. 
23). Some industry trade associations have asked FDA and CDC to convene 
a meeting with industry representatives and work together to minimize 
the human and economic impact of an outbreak (Ref. 24). These

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trade associations urged FDA and CDC to work in partnership with 
industry to find solutions to speed up and streamline outbreak 
identification and response. These trade associations also recommended 
that a working group be established to look at crisis management 
systems and that teams of industry experts be established to help in 
traceback investigations.

I. Issues and Questions for Discussion

    As previously noted, we need to increase the speed and accuracy of 
traceback investigations to help limit the public health impact of a 
foodborne illness outbreak; to limit to a particular region, locality, 
farm(s), or processor(s) the source of the problem (where the source is 
in fact limited), so that an entire industry is not unnecessarily 
affected; to enable public health authorities and the food industry to 
provide targeted and accurate information about affected food to 
consumers; to institute steps to correct the source of contamination; 
and, as a result, to restore or enhance consumer confidence in produce 
safety.
    We intend the public meetings to stimulate and focus a discussion 
about mechanisms to enhance product tracing systems for fresh produce 
and to improve FDA's ability to use the information in such systems to 
identify the source of contamination associated with fresh produce-
related outbreaks of foodborne illness. This discussion will help FDA 
determine what short and long term steps, such as issuing regulations, 
we should take to enhance the current tracing system. Aspects of these 
measures could require new legal authority. We welcome public comments 
and/or data on the following issues related to product tracing systems 
for fresh produce:
    1. Should a ``fresh produce identifier'' be assigned to fresh 
produce? If so, at what stage or stages in the supply chain should such 
an identifier be assigned or modified? What data or information would 
be useful to include in such an identifier? Should the identifier be 
placed on the fresh produce, the package, the shipping container, and/
or the invoice or bill of lading? Should the location of the identifier 
depend on the type of produce or on other factors?
    Our investigations of the 2006 outbreak associated with packaged 
fresh spinach and the 2007 outbreak associated with peanut butter were 
greatly facilitated by a product ``code'' that the party who packaged 
the implicated product had assigned to the packaged product. We seek 
comment on whether a ``fresh produce identifier'' should be assigned to 
fresh produce, and, if so, at what stage or stages in the supply chain 
and with what information elements.
    2. What other data or information would be useful on the invoice or 
bill of lading, fresh produce, package, or shipping case? At what stage 
or stages in the supply chain should such data or information be 
included?
    The product ``codes'' assigned to the packaged fresh spinach 
associated with the 2006 outbreak and to the peanut butter associated 
with the 2007 outbreak were present on the packaged products. We seek 
comment on whether any other data or information (in addition to or 
instead of the fresh produce identifier discussed in question 1) should 
be on or attached to the invoice, bill of lading, fresh produce, its 
package (when feasible), or the shipping case.
    3. Should an enhanced product tracing system extend to all fresh 
produce? If not, what criteria should be used to determine coverage?
    There are a number of factors that may increase or decrease the 
risk for contamination of produce. Such factors may include crop 
characteristics (e.g., proximity of the edible portion of the crop to 
the soil, or rough surface, such as cantaloupe); production practices 
or conditions (e.g., water quality for field and packing operations); 
method of irrigation; likelihood of animal intrusion; and worker health 
and hygiene. Should these or other factors (e.g., history of outbreaks) 
be considered in prioritizing the development and application of an 
enhanced product tracing system?
    4. Should fresh produce be commingled? If commingling is 
unavoidable, what practices should an enhanced product tracing system 
include to ensure that fresh produce can be traced effectively and 
efficiently?
    Some industry food safety guidelines advise against commingling 
(Ref. 8). Should parties in the supply chain for some or all 
commodities consider refining or designing their product tracing 
systems so that they can identify the source of individual pieces of 
fresh produce if they combine or commingle produce from multiple 
sources and link this information to the one-up/one-down records they 
establish and maintain? If such identification is not feasible, should 
parties in the supply chain for some or all commodities consider no 
longer combining or commingling produce? We seek comment on any 
measures already in place to address product tracing of commingled 
fresh produce and the extent to which such measures have been 
demonstrated to be successful in ensuring product tracing, particularly 
during traceback investigations.
    5. What should be the scope of an enhanced product tracing system 
for fresh produce?
    As stated previously, the supply chain for fresh produce is often 
complex. We seek comment concerning how an enhanced product tracing 
system for fresh produce should apply to various parties in the supply 
chain, including producers, packers, distributors, and retailers. More 
specifically, we seek comment on whether some or all aspects of an 
enhanced product tracing system for fresh produce should apply to some 
or all farms. For example, if a fresh produce identifier includes 
information about the date of harvest, the farm is the party who would 
have that information. It may be more practical for the farm to 
identify the date of harvest on the invoice when it ships the fresh 
produce than for the first party in the supply chain to subsequently 
contact the farm to determine the date of harvest.
    We also seek comment on whether some or all aspects of an enhanced 
product tracing system for fresh produce should apply to some or all 
restaurants or retailers. For example, if a ``fresh produce 
identifier'' is assigned to produce a restaurant receives, we seek 
comment on whether the restaurant could establish and maintain records 
of that identifier or could retain the invoice or bill of lading if the 
information is contained on those documents.
    We also seek comment on whether some or all aspects of an enhanced 
product tracing system for fresh produce should extend to consumers. 
Product tracing systems currently used by the fresh produce industry 
typically do not reach the consumer level. However, some segments of 
the supply chain can and do record some individual consumer 
information, and may be able to use this information to alert specific 
consumers about product recalls or for other purposes. For example, a 
retailer who has a ``frequent customer'' or ``bonus card'' program may 
record each cardholder's purchases. The retailer's consumer purchasing 
information also would be very helpful in those situations where the 
fresh produce that is possibly linked to a foodborne illness outbreak 
is eaten and the consumers have disposed of any identifiers on the 
fresh produce before a traceback investigation begins. Could such 
systems be adapted or modified to provide assistance with traceback 
investigations? Would there be any issues or concerns associated with 
such systems?

[[Page 55121]]

    6. Should the data or information in an enhanced product tracing 
system be human-readable, technology-based, or both? If technology-
based, what technology should be used?
    ``Human-readable'' information should enable all parties in the 
supply chain, regardless of the technology used, to read this 
information. By ``human-readable,'' we mean information consisting of 
numbers and/or letters capable of being read by the human eye. 
Technology-based systems could make it faster and easier to accurately 
record information such as a fresh produce identifier. For example, a 
person making a paper record of a human-readable identifier expressed 
in numbers or letters may mistakenly transpose or omit numbers or 
letters, thus creating erroneous entries in the records. In contrast, 
the potential for such mistakes is greatly reduced if the identifier is 
recorded using an automatic system such as a bar code or RFID. In 
addition, technology-based systems could greatly speed a traceback 
investigation. However, some parties may not have access to electronic 
technologies. We seek comment on whether data or information in an 
enhanced product tracing system should be human-readable, technology-
based, or both. If technology-based, what technology should be used?
    7. What (if any) data or information in an enhanced product tracing 
system should be standardized?
    The lack of standardization in the information in current product 
tracing systems can frustrate traceback investigations. We seek comment 
on whether the various segments of the fresh produce industry should 
develop standards for the content and format of records, particularly 
of electronic records that could help make electronic record systems 
interoperable. We seek comment on the existence and utility of existing 
standards relevant to some or all of the information elements that 
would be in an enhanced product tracing system, such as in a fresh 
produce identifier. We also seek comment on whether such standards 
should be developed and on whether current or newly developed standards 
should be identified in any guidance or regulations issued by FDA. We 
also seek comment on whether and how current or newly developed 
standards for the content and format of electronic systems could have 
practical utility for parties who continue to use paper-based 
technology. For example, could human-readable data that support 
standardized technology-based data be useful to parties who continue to 
use paper-based technology?
    8. What are the costs, benefits, and feasibility of implementing an 
enhanced product tracing system?
    Further enhancing the product tracing system for fresh produce 
could aid us in shortening the duration of outbreaks and limiting the 
number of people who become ill. It could also give us more information 
to use in preventing future outbreaks. However, these benefits will not 
come equally from all types of fresh produce. Enhancing the product 
tracing system beyond current practices and requirements for certain 
types of fresh produce might not significantly enhance public health if 
the fresh produce has not been associated with foodborne illness or any 
known risk factors. An enhanced fresh product tracing system for fresh 
produce may also impose burdens on entities in the supply chain. We 
seek comment on the costs, benefits, and feasibility of implementing an 
enhanced product tracing system for each of the parties in the supply 
chain.
    We recognize that enhancing product tracing of fresh produce may 
not be just a matter of keeping more or different records or adding 
more information to product or packaging, but also of changing business 
practices. We request comment on the extent to which an enhanced 
product tracing system for fresh produce will affect comingling and 
repacking of produce and the cost of any such changes in the supply 
chain.
    9. Would enhancing FDA's role in developing and implementing 
effective product tracing systems for fresh produce, through increased 
regulation, guidance, or additional legal authorities, improve the 
effectiveness of traceback investigations and traceforward operations? 
What mandatory and voluntary measures would be most effective in 
achieving the goal of enhancing product tracing systems for fresh 
produce and improving FDA's ability to use the information in such 
systems to identify the source of contamination associated with fresh 
produce-related outbreaks of foodborne illness? How would these 
measures help FDA work better with industry and other stakeholders 
during traceback investigations and traceforward operations?

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see table 1 of this document) written or electronic comments for 
consideration at or after the meeting in addition to, or in place of, a 
request for an opportunity to make an oral presentation. 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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

V. References

    We have placed the following references on display in the Division 
of Dockets Management (see table 1 of this document). You may see them 
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 Web sites after this document publishes in the Federal 
Register.)
    1. U.S. Food and Drug Administration, 1996-2007 Produce 
Outbreaks (unpublished compilation).
    2. Codex Alimentarius Commission. 2006. Principles for 
Traceability/Product Tracing As a Tool Within A Food Inspection and 
Certification System. CAC/GL60-2006. Available at http://www.codexalimentarius.net/web/standard_list.do?lang=en. Accessed 
and printed on July 18, 2008.
    3. U.S. Food and Drug Administration. 2004. ``What You Need to 
Know About Establishment and Maintenance of Records.'' Available at 
http://www.cfsan.fda.gov/~acrobat/fsbtrec.pdf.
    4. U.S. Food and Drug Administration. ``Questions and Answers 
Regarding Establishment and Maintenance of Records. Edition 4.'' 
Available at http://www.cfsan.fda.gov/~dms/recguid4.html.
    5. Produce Marketing Association and Canadian Produce Marketing 
Association. 2006. Fresh Produce Traceability. A Guide To 
Implementation. Available at http://www.pma.com/cig/tech/traceability.cfm. Accessed and printed on June 18, 2008.
    6. Roberta Cook, ``The U.S. Fresh Produce Industry: An Industry 
in Transition,'' in Postharvest Technology of Horticultural Crops 
(Adel Kader ed., 2001).
    7. U.S. Department of Agriculture, Agricultural Marketing 
Service. Issued February 2006. Fresh Fruit and Vegetable Shipments 
By Commodities, States, and Months. FVAS-4 Calendar Year 2005. 
Available at http://www.ams.usda.gov. Accessed and printed on July 
22, 2008.
    8. North American Tomato Trade Work Group. 2008. Commodity 
Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, 
Edition 2. Available at http://www.californiatomatofarmers.com/pdfs/TomatoGuidelinesJuly08.pdf. Accessed and printed on September 11, 
2008.

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    9. U.S. Department of Agriculture, Economic Research Service 
(Golan, E., Krissoff B., Kuchler F., Nelson K., Price G.). 2004. 
Agricultural Economic Report No. 830. ``Traceability in the U.S. 
Food Supply: Economic Theory and Industry Studies,'' p. 17 (p. 25 of 
the electronic document). Available at http://www.ers.usda.gov/publications/aer830/aer830.pdf. Accessed and printed on August 4, 
2008.
    10. California Tomato Farmers. Food Safety Program. Available at 
http://www.californiatomatofarmers.com/foodsafety.asp. Accessed and 
printed on August 4, 2008.
    11. Produce Industry Food Safety Initiative co-sponsored by the 
Produce Marketing Association and the United Fresh Fruit and 
Vegetable Association. 2005. Commodity Specific Food Safety 
Guidelines for the Melon Supply Chain. 1st Edition. Available at 
http://www.cfsan.fda.gov/~dms/melonsup.html. Accessed and printed on 
August 7, 2008.
    12. International Fresh-cut Produce Association, Produce 
Marketing Association, United Fresh Fruit and Vegetable Association, 
and Western Growers. 2006. Commodity Specific Food Safety Guidelines 
for the Lettuce and Leafy Greens Supply Chain. 1st Edition. 
Available at http://www.cfsan.fda.gov/~dms/lettsup.html. Accessed 
and printed on August 7, 2008.
    13. Wal-Mart, Inc., press release, February 4, 2008. Available 
at http://walmartstores.com/FactsNews/NewsRoom/7918.aspx. Accessed 
and printed on August 29, 2008.
    14. Global Food Safety Initiative, GFSI Guidance Document, 5th 
Edition, September 2007. Available at http://www.ciesnet.com/pfiles/programmes/foodsafety/GFSI_Guidance_Document_5th%20Edition%20_September%202007.pdf. Accessed and printed on September 4, 2008.
    15. Produce Marketing Association, Canadian Produce Marketing 
Association, and United Fresh Produce Association. 2007. Joint 
Release. Available at http://www.cpma.ca/pdf/IndustryTech/Traceability_Joint_Release_PMA_CPMA_UFPA_Oct2007.pdf. Accessed 
and printed on July 22, 2008.
    16. CPMA/PMA Traceability Task Force. Traceability Best 
Practices. Fresh Produce Industry (North America). Available at 
http://www.cpma.ca/pdf/IndustryTech/TraceabilityBestPractices.pdf. 
Accessed and printed on July 18, 2008.
    17. U.S. Government Accounting Office. 2008. Report to 
Congressional Requestors. Food Safety. Selected Countries Can Offer 
Insights into Ensuring Import Safety and Responding to Foodborne 
Illness. GAO 08-794. Available at http://www.gao.gov/new.items/d08794.pdf. Accessed and printed on July 18, 2008.
    18. European Commission. Health and Consumer Protection 
Directorate General. 2007 Factsheet. Food Traceability. Available at 
http://ec.europa.eu/food/food/foodlaw/traceability/factsheet_trace_2007_en.pdf. Accessed and printed on July 20, 2008.
    19. Standing Committee On The Food Chain And Animal Health. 
Guidance On The Implementation Of Articles 11, 12, 16, 17, 18, 19 
AND 20 of Regulation (EC) N[deg] 178/2002 on General Food Law. 
Available at http://ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_7_en.pdf. Accessed and printed on September 3, 2008.
    20. Commission of the European Communities, ``Commission 
Regulation (EC) No 178/2002 of the European Parliament and of the 
Council of 28 January 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety.'' 
Official Journal of the European Union, 1.2.2002 L31/1-L31/24, 2002. 
Available at http://eur-lex.europa.eu/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf. Accessed and printed on July 22, 2008.
    21. Traceback--Keeping Track of the Food Trail. Available at 
ftp://ftp.cordis.europa.eu/pub/food/docs/traceback.pdf. Accessed and 
printed on July 24, 2008.
    22. GS1 Global Traceability Standard. Available at http://www.gs1.org/productssolutions/traceability/. Accessed and printed on 
July 18, 2008.
    23. Letter dated July 3, 2008 from Michael F. Jacobson and 
Caroline Smith de Waal of the Center for Science in the Public 
Interest and Chris Waldrop of the Consumer Federation of America to 
Andrew C. von Eschenbach of the U.S. Food and Drug Administration. 
Available at http://cspinet.org/new/pdf/von_eshenbach_traceability_letter.pdf. Accessed and printed on July 19, 2008.
    24. Letter dated July 3, 2008, from Thomas E. Stenzel of United 
Fresh Produce Association and Bryan Silbermann of Produce Marketing 
Association to Secretary Michael O. Leavitt of the U.S. Department 
of Health and Human Services. Available at http://www.unitedfresh.org/assets/files/PMA_UFPA_2nd_HHS_Meeting_Request_7308.pdf. Accessed and printed on July 21, 2008.

    Dated: September 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22430 Filed 9-19-08; 4:15 pm]
BILLING CODE 4160-01-S