[Federal Register: November 3, 2009 (Volume 74, Number 211)]
[Notices]
[Page 56843-56855]
[DOCID:fr03no09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0523]

Product Tracing Systems for Food; Public Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comment.

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SUMMARY:  The Food and Drug Administration (FDA), in collaboration with
the United States Department of Agriculture, Food Safety and Inspection
Service (FSIS), is announcing a public meeting regarding product
tracing systems for food intended for humans

and animals. The purpose of the meeting is to stimulate and focus a
discussion about mechanisms to enhance product tracing systems for
food. This discussion will help FDA and FSIS determine what short and
long term steps the two agencies 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 electronic registration, electronic requests to make an oral
presentation during the time allotted for public comment at the
meeting, logistics, or to request a sign language interpreter or other
special accommodation due to a disability: Sheila Johnson,
Congressional and Public Affairs, 1400 Independence Ave., SW.,
Washington, DC, 20250,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    FSIS: For questions about meat, meat food products, poultry,
poultry products, and egg products: William Smith, Assistant
Administrator, Office of Program Evaluation, Enforcement & Review, rm.
3133, South Agriculture Building, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC, 20250,<PHONE_NUMBER>.
    FDA: For non-electronic registration (i.e., registration by mail,
fax, e-mail, or phone), for submission of written material for an oral
presentation, and for questions about all other food: Juanita Yates,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-009), 5100 Paint Branch Pkwy., College Park, MD
20740,<PHONE_NUMBER>, toll-free FAX: 1-877-366-3322, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Purpose of the Meeting

    As discussed more fully in section IV.A of this document, Federal
food safety agencies need to increase the speed and accuracy of
traceback investigations and traceforward operations. FDA and FSIS
intend the public meeting to stimulate and focus a discussion about the
core elements of product tracing systems, gaps in current product
tracing systems, and mechanisms to enhance product tracing systems for
food. FDA and FSIS also intend the public meeting to improve the
ability of FDA and FSIS to use the information in such systems to
identify the source of contamination during outbreaks of foodborne
illness, and to improve the ability of all persons in the supply chain
to more quickly identify food that is (or potentially is) contaminated
and remove it from the market during traceforward operations. This
discussion will help FDA and FSIS determine what short and long term
steps each agency should take to enhance the current tracing system.
    For purposes of this document, the term ``food'' applies to both
food for humans and food for animals.\1\ As defined by the Codex
Alimentarius Commission (Codex),\2\ traceability/product tracing is the
ability to follow the movement of a food through specified stage(s) of
production, processing, and distribution (Ref. 1).
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    \1\ Under section 201(f) of the Federal Food, Drug, and Cosmetic
Act (the FFDCA), food is defined as (1) articles used for food or
drink for man or other animals, (2) chewing gum, and (3) articles
used for components of any such article.
    \2\ 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.
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II. How to Participate in the Meeting

    Stakeholders will have an opportunity to provide oral comments. Due
to limited space and time, and to facilitate entry to the building in
light of security procedures, FDA and FSIS encourage all persons who
wish to attend the meeting, including those requesting an opportunity
to make an oral presentation during the time allotted for public
comment at the meeting, to register in advance. Depending on the number
of requests for such oral presentations, there may be a need to limit
the time of each oral presentation (e.g., 5 minutes each). If time
permits, requests may be granted for an opportunity to make such an
oral 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 to the Docket
established for the meeting.

 Table 1--Information on Participation in the Meetings and on Submitting
                                Comments
------------------------------------------------------------------------
                                           Electronic         Other
                 Date        Address        Address        Information
------------------------------------------------------------------------
Public       December 9   Jefferson      .............  Attendees must
 meeting      and 10,      Auditorium                    provide a
              2009, from   at the U.S.                   picture ID to
              9 a.m.       Department                    enter the
              until 5      of                            building. The
              p.m.         Agriculture                   Jefferson
                           (South                        auditorium is
                           Building),                    located at Wing
                           1400                          6 in the South
                           Independence                  Building.
                           Ave., SW.,                    Attendees
                           Washington,                   should enter
                           DC, 20250                     the building at
                           (Metro stop:                  Wing 7 at the
                           Smithsonian                   14th Street
                           Metro                         entrance.
                           Station on                   ................
                           the blue and                 Participation is
                           orange                        also being made
                           lines, take                   available via
                           the                           teleconference.
                           Independence                  The call-in
                           Ave. exit)                    information
                                                         will be located
                                                         at the bottom
                                                         of the
                                                         registration
                                                         form.
------------------------------------------------------------------------

Advance      December 2,  We encourage   http://        A request for an
 registrati   2009         you to use     www.fsis.usd   oral
 on                        electronic     a.gov/News/    presentation
                           registration   Meetings--&-   should specify
                           if             -Events.       whether the
                           possible.\1\  Please          presentation
                                          complete the   will be
                                          registration   directed to
                                          form           FDA, FSIS, or
                                          including      both. Depending
                                          all required   on the number
                                          fields.        of requests, it
                                                         may be possible
                                                         to allot two
                                                         presentation
                                                         times to
                                                         persons who
                                                         request an
                                                         opportunity to
                                                         direct a
                                                         presentation to
                                                         both FDA and
                                                         FSIS.
                                                        Registration
                                                         information and
                                                         information on
                                                         requests to
                                                         make an oral
                                                         presentation
                                                         may be posted
                                                         without change
                                                         to http://
                                                         www.regulations
                                                         .gov, including
                                                         any personal
                                                         information
                                                         provided.
-------------------------
Make a       November     .............  .............  ................
 request      23, 2009
 for an
 oral
 presentati
 on during
 the time
 allotted
 for public
 comment
------------------------------------------------------------------------
Provide a    December 2,  Juanita Yates  .............  Written material
 brief        2009         (see FOR                      associated with
 descriptio                FURTHER                       an oral
 n of the                  INFORMATION                   presentation
 oral                      CONTACT)                      may be posted
 presentati                                              without change
 on and any                                              to http://
 written                                                 www.regulations
 material                                                .gov, including
 for the                                                 any personal
 presentati                                              information
 on                                                      provided.
------------------------------------------------------------------------
Request a    November     Sheila         .............  ................
 sign         30, 2009     Johnson (see
 language                  FOR FURTHER
 interprete                INFORMATION
 r or other                CONTACT)
 special
 accommodat
 ion due to
 a
 disability
------------------------------------------------------------------------
Submit       by March 3,  http://        All comments
 comments     2010.Divis   www.regulati   should be
              ion of       ons.gov        identified
              Dockets                     with the
              Management                  docket
              (HFA-305),                  number found
              Food and                    in brackets
              Drug                        in the
              Administra                  heading of
              tion, 5630                  this
              Fishers                     document.
              Lane rm.                    For
              1061,                       additional
              Rockville,                  information
              MD 20852                    on
                                          submitting
                                          comments,
                                          see section
                                          VII 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
  Juanita Yates (see FOR FURTHER INFORMATION CONTACT).

III. 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.

IV. Background

A. Introduction

    The public meeting is intended to address product tracing systems
to facilitate traceback investigations and traceforward operations for
food products. A traceback investigation is an investigation to
determine and document the distribution and production chain, and the
source(s), of contaminated (and potentially contaminated) food, often
in the context of an outbreak of foodborne illness. A traceforward
operation is an operation to determine the distribution of contaminated
(and potentially contaminated) food. An outbreak of foodborne illness
is the occurrence of two or more cases of a similar illness resulting
from the ingestion of a common food.
    Food can become contaminated at many different steps in the farm-
to-table continuum: On the farm; in packing, manufacturing/processing,
or distribution facilities; during storage or transit; at retail
establishments; in restaurants; and in the home. In recent years, FDA
and FSIS have taken a number of actions to prevent both deliberate and
unintentional contamination of food at each of these steps. FDA and
FSIS have worked with other Federal, State, local, territory, 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. However,
changes in consumer preferences, change in industry practices, and the
rising volume of imports continue to pose significant challenges for
FDA and FSIS (72 FR 8750, February 27, 2007; 73 FR 55115, September 24,
2008; 67 FR 62325, October 7, 2002; and Ref. 2). Recently, thousands of
processed food products have been recalled due to contamination (and
potential contamination) of ingredients (e.g., peanuts and peanut-
derived products, pistachios, and dried milk) with a pathogenic
microorganism (e.g., Salmonella) or chemical (e.g., melamine) (Refs. 3
through 6). In addition, contamination (and potential contamination) of
ground beef with a pathogenic microorganism (e.g., Escherichia coli
O157:H7) has led to recalls involving millions of pounds of ground beef
(Ref. 7). These food contamination events, often involving foodborne
illnesses, have emphasized the importance of efficient and effective
product tracing systems, particularly the importance of linking
shipments of contaminated (and potentially contaminated) food backward
and forward through the supply chain through the efficient assembly and
review of product tracing records.
    In some cases, a firm that receives, manufactures, or distributes
food, or a regulatory official detects contamination of a food in the
market, without any known or suspected association between the food and
reports of foodborne illness. When the contamination could cause
foodborne illness, quick action is necessary to remove the food from
the market. A traceforward operation to determine the distribution of
all contaminated (and potentially contaminated) food may be initiated
for any type of food in the market, e.g., a raw agricultural commodity,
a food ingredient, or any single- or multi-ingredient processed food.
In recent years, traceforward operations for food ingredients have
highlighted the potentially large impact that contamination (or
potential contamination) of a single food ingredient can have on
thousands of food products containing that ingredient (Refs. 3 through
6).
    In other cases, food that has become contaminated goes undetected
until it is associated with an outbreak of foodborne illness. 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
(HHS), and State, local, territory and/or tribal health departments
conduct epidemiologic investigations to identify the possible food(s)
involved in an outbreak. In general, when it is concluded that the
contamination occurred at the point of sale, such as a restaurant
(e.g., due to illness of a food worker or environmental contamination
at the point of sale), FDA or FSIS does not get involved with the
investigation. If it appears that the contamination did not occur at
the point of sale, CDC and/or the State/local/territory/tribal entity
notify FDA, FSIS, or both about the outbreak and the specific food that
is potentially associated with the outbreak.
    After CDC and/or the State/local/territory/tribal entity notify FDA
or FSIS that a specific food is potentially associated with an outbreak
of foodborne illness, the notified agency (or agencies) reviews and
evaluates the available data and information. Based upon the agency's
review and evaluation of epidemiologic data and/or laboratory results,
the notified agency may initiate a traceback investigation to identify
the source of the food and, potentially, of the contamination. As with
a traceforward operation, a traceback investigation may be initiated
for any type of food in the market, e.g., a raw agricultural commodity,
a food ingredient, or any single- or multi-ingredient processed food.
Working with industry and with other domestic (and, in some cases,
foreign) government agencies, the notified agency inspects or
investigates each point throughout the supply chain to determine where
the contamination likely occurred. In the course of an investigation,
the notified agency may examine the facility, ingredients, finished
products, packaging, and food handling practices (such as how long food
is held before shipping, whether the facility practices ``first in-
first out'' when selling products, and whether finished products or
ingredients are shared or exchanged with other facilities).
    Timely and accurate information gained from records available
during a traceback investigation or traceforward operation may:
     Help limit the public health impact of a foodborne illness
outbreak, for example, by enabling a more rapid traceforward operation
to remove the contaminated (or potentially contaminated) food 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
food safety;
     Help limit the source of the problem to a particular food
(e.g., brand), or to a particular region or locality (e.g., as a source
of contaminated (or potentially contaminated) fresh produce) so that
firms or regions that are not connected to the contaminated (or
potentially contaminated) food are not adversely affected by an
outbreak investigation or by a recall; and
     Help prevent future outbreaks by enabling the applicable
Federal or State regulatory agency to more rapidly investigate firms
where contamination may have occurred, so that conditions and practices
that may have been associated with the contamination can be observed
and the lessons learned can be used to prevent contamination in the
future.
    Current records (maintained by the various persons in the supply
chain) that contain product tracing information include external
records (such as bills of lading, airway bills, manifests, invoices,
shipping records, and packing lists) that a firm establishes to
accompany commercial transactions and internal records (such as batch
production records, inventory records, and distribution records) that a
firm establishes for its own use and may consider proprietary. Existing
FDA requirements to establish and maintain information to facilitate
product tracing require a firm to make certain information available to
FDA, within 24 hours, when FDA has a reasonable belief that an article
of food is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals (see FDA's regulations
entitled ``Establishment, Maintenance, and Availability of Records''
(21 CFR part 1, subpart J)).\3\ However, this information need not be
kept as one record (see 21 CFR 1.330).
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    \3\ For more information on the recordkeeping regulations in 21
CFR part 1, subpart J, see Refs. 8 and 9).
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    Similarly, FSIS requires certain classes of firms and corporations
to maintain, retain, and make available to FSIS records that fully and
correctly disclose all transactions involved in their businesses
subject to the Federal Meat Inspection Act (21 U.S.C. 642), the

Poultry Products Inspection Act (21 U.S.C. 460(b)), and the Egg
Products Inspection Act (21 U.S.C. 1040). Records kept by FSIS-
regulated businesses that may contain product tracing information
include, but are not limited to, bills of sale, invoices, bills of
lading, and receiving and shipping papers (see 9 CFR 320.1, 381.175,
and 590.200). Upon the presentation of credentials by a representative
of the Secretary of Agriculture, these records must be made available
for examination and copying (see 9 CFR 320.4, 381.178, and 590.220).
    In practice, reviewing multiple records to find information
relevant to a particular traceback investigation or traceforward
operation takes time and decreases the efficiency of product tracing.
Recent traceforward operations have demonstrated that it can take
months for foods containing a contaminated (or potentially
contaminated) ingredient to be removed from the market (Refs. 3 through
6). Enhancing recordkeeping systems to be able to more rapidly link a
specific lot of an incoming ingredient to all released food containing
that specific lot of ingredient could improve the efficiency of
traceforward operations for food products containing a contaminated (or
potentially contaminated) food ingredient.
    Likewise, recent traceback investigations conducted by FDA
demonstrate that FDA's ability to identify the source of an outbreak
can range from days to months after CDC notifies FDA that a specific
food has been implicated in an outbreak (Ref. 10). At the start of a
traceback investigation, FDA reviews records at the point of sale, such
as a grocery store, where the product was purchased. The review of
records at point of sale usually leads to the review of records at a
distribution center. Key challenges at the point of sale include
identifying shipments of interest and narrowing the number of shipments
of potentially contaminated food. Key challenges at the distribution
center include difficulties in linking a shipment released by a
distribution center to the point of sale and difficulties linking
outgoing shipments of food products released from the distribution
center with incoming shipments of food products received by the
distribution center. These challenges in the review of records at point
of sale and at distribution centers delay the traceback investigation
and may result in a wider scope of product potentially implicated.
    Together these traceback investigations and traceforward operations
have demonstrated that FDA needs to be able to respond to the size and
complexity of the food supply chain with a product tracing system that
is more sophisticated, effective, and efficient in its capacity to link
the contaminated food along the distribution chain and that reflects
and responds to changing production and distribution patterns.
    FSIS is also hindered by similar problems. FSIS relies heavily on
records maintained by manufacturers, distributors, and retailers to aid
in identifying and tracing back FSIS-regulated products associated with
foodborne illness outbreaks, recalls, and other food safety incidents.
Retail records are a critical component in traceback and traceforward
activities. Quickly and effectively determining the source product in
these situations is essential in identifying the product in commerce
that presents a risk to the public and preventing additional illnesses.
    Many investigations into human illness involve the consumption of
raw beef products ground or chopped by FSIS-inspected establishments or
retail facilities. FSIS investigators and public health officials
frequently use records kept at all levels of the food distribution
chain, including the retail level, to identify and traceback the
product that is the source of the illness. In cases of E. coli O157:H7
complaints or illnesses, FSIS personnel often have to rely on raw beef
grinding records kept by official meat establishments, retail
facilities, and meat markets to gather the information needed to
undertake traceback actions.
    Recent illness outbreak investigations and other activities
conducted by FSIS have demonstrated inadequate recordkeeping by some
retail-level businesses and FSIS-inspected establishments that produce
ground beef. The agency has found that the records kept by these
establishments are often incomplete and have missing or inaccurate
information. The lack of proper recordkeeping by these businesses has
contributed to:
     Increasing the amount of time needed to identify products
of interest,
     Inability to traceback product to the source material,
     Inability to identify all potentially adulterated products
in distribution,
     Increasing the possibility that the wrong window of
production is identified,
     Broader actions by the agency such as public health alerts
and not directed recalls,
     Increased cost to the agency, and
     Increased risk to the consumer through the increased time
delay, possibility of incorrect product identification, and limited
specificity in public health messages.
    Like FDA, FSIS needs to take steps to change this situation. In
particular, FSIS needs to assess the need to provide notice, outreach,
compliance guides, or other information to industry to promote
awareness of, and compliance with, records and food safety
requirements.
    While there are many significant challenges with traceback/
traceforward investigations, there are successes. In 2007, the
Minnesota Department of Health (MDH) conducted a traceback/traceforward
investigation that resulted in the recall of approximately 117,500
pounds of beef trim products used to make ground beef. MDH conducted an
epidemiological investigation of a cluster of nine E. coli O157:H7
case-patients with an indistinguishable pulsed field gel
electrophoresis (PFGE) pattern combination who had reported eating
ground beef. A case-control study conducted by MDH found that consuming
ground beef purchased at retail outlets located in eight different
States was significantly associated with illness. Leftover product from
the case-patients collected and tested by the Minnesota Department of
Agriculture (MDA) were found presumptive positive for E. coli O157:H7.
In this case, the traceback/traceforward investigation was facilitated
by MDA investigators' use of purchase date and store location
information from case-patients, along with complete and accurate
grinding logs from the retail stores. This enabled MDA to definitively
identify the production date of the implicated product and the single
federal meat establishment from which the product came.

B. Statutory and Regulatory Framework for Product Tracing Systems in
the United States

1. FDA
    Several sections in the FFDCA (such as sections 301, 402, 403, 412,
414, 416, 417 and 704(a)) (21 U.S.C. 321, 342, 343, 350(a), 350(c),
350(e), 350(f), and 374(a)) and section 361 of the Public Health
Service Act (42 U.S.C. 264) provide authority for, or are otherwise
relevant to, product tracing systems. Using these authorities, FDA has
established a number of regulations relevant to product tracing
systems, such as those listed in table 2 of this document. Regulations
established in 21 CFR part 1, subpart J apply to both human food and
food for animals. The listed regulations established in 21 CFR parts
101, 106, 111, 113 and 114 apply to human food (21 CFR 500.23, however,

extends Sec.  113's application to animal foods). The listed
regulations established in 21 CFR part 501 apply to food for animals.

        Table 2--Regulations Relevant to Product Tracing Systems
------------------------------------------------------------------------
 Regulation(s)         Subject                Brief Description
------------------------------------------------------------------------
21 CFR part 1,   Establishment,      Requires certain persons who
 subpart J        Maintenance, and    manufacture, process, pack,
                  Availability of     transport, distribute, receive,
                  Records             hold, or import food to establish
                                      and maintain certain records
                                      identifying the immediate previous
                                      source of all food received, as
                                      well as the immediate subsequent
                                      recipient of all food released.
                                      The regulations describe the
                                      information that must be
                                      established and maintained, how
                                      long it must be maintained, and
                                      how quickly it must be available
                                      to FDA when FDA has a reasonable
                                      belief that an article of food is
                                      adulterated and presents a threat
                                      of serious adverse health
                                      consequences or death to humans or
                                      animals. The regulations also
                                      describe persons (e.g., farms and
                                      restaurants) who are excluded from
                                      some or all of the requirements.
------------------------------------------------------------------------
21 CFR 101.3     Identity labeling   Requires the principal display
21 CFR 501.3      of food in          panel of a food in package form to
                  packaged form       bear a statement of the identity
                                      of the commodity.
------------------------------------------------------------------------
21 CFR 101.5     Food; name and      Requires the label of a food in
21 CFR 501.5      place of business   packaged form to specify
                  of manufacturer,    conspicuously the name and place
                  packer, or          of business of the manufacturer,
                  distributor.        packer, or distributor.
------------------------------------------------------------------------
21 CFR 106.90    Infant Formula      Requires product coding for all
                  Quality Control     infant formulas.
                  Procedures
------------------------------------------------------------------------
21 CFR part 111  Current Good        Requires, among other things,
                  Manufacturing       identification of each lot of
                  Practice in         received components in a manner
                  Manufacturing,      that allows tracing the lot to the
                  Packaging,          supplier and the date received;
                  Labeling, or        using this unique identifier when
                  Holding             recording the disposition of the
                  Operations for      lot of received components;
                  Dietary             establishing a batch, lot or
                  Supplements         control number for each finished
                                      batch of dietary supplements; and
                                      being able to determine the
                                      complete manufacturing history and
                                      control of the packaged and
                                      labeled dietary supplement through
                                      distribution.
------------------------------------------------------------------------
21 CFR            Thermally  A product code must be established
 113.60(c);       Processed Low-      and included on the package of a
21 CFR            Acid Foods          food that is a thermally processed
 114.80(b)        Packaged In         low-acid food packaged in a
                  Hermetically        hermetically sealed container
                  Sealed              (Sec.   113.60(c)) or an acidified
                  Containers;         food (Sec.   114.80(b)).
                  Acidified
                  Foods
------------------------------------------------------------------------

    Section 417 of the FFDCA establishes requirements for FDA to
establish a Reportable Food Registry (RFR). A ``reportable food'' is an
article of food (other than dietary supplements or infant formula) for
which there is a reasonable probability that the use of, or exposure
to, such article of food will cause serious adverse health consequences
or death to humans or animals. The purpose of the RFR is to provide a
``reliable mechanism to track patterns of adulteration in food [which]
would support efforts by the Food and Drug Administration to target
limited inspection resources to protect the public health'' (Public Law
110-085, section 1005(a)(4)). In accordance with section 417 of the
FFDCA, FDA implemented on September 8, 2009, the RFR electronic portal
by which instances of reportable food must be submitted to FDA by
responsible parties and may be submitted by public health officials.
Information as to the immediate prior source of the food and/or
ingredients and the immediate subsequent recipient(s) of the food may
be required to be submitted through the electronic portal. FDA has
issued a guidance document (Ref. 11) containing questions and answers
relating to the requirements under section 417 of the FFDCA.
2. FSIS
    Like FDA, FSIS' statutes have sections that are relevant to product
tracing systems for meat, poultry, and egg products subject to FSIS'
jurisdiction. Sections 642 of the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), 460(b) of the Poultry Products Inspection Act (21
U.S.C. 451 et seq.), and 1040 of the Egg Products Inspection Act (21
U.S.C. 1031 et seq.) require certain classes of firms and corporations
to maintain, retain, and make available full and correct business
records or transactions in food. The regulations implementing those
statutory sections, 9 CFR part 320, 9 CFR part 381, and 9 CFR 590.200,
specify businesses and what types of basic records are required, such
as bills of sale, bills of lading, receiving and shipping papers,
receipts and inventories. Under the Federal Meat Inspection Act, FSIS
also has the authority, under certain circumstances, to mandate
specified recordkeeping by retail stores for certain violations and to
withdraw or modify statutory exemptions for public health reasons (21
U.S.C. 623 and 454, 9 CFR parts 301 and 381).
    Under FSIS' Hazard Analysis and Critical Control Points (HACCP)
regulations (9 CFR part 417), a meat or poultry establishment is
required to keep records related to its HAACP plan, including all
records associated with its operation (i.e., monitoring, verification,
and corrective action). The records of these activities are subject to
FSIS review and are to be made available to FSIS personnel (9 CFR
417.5(e) and (f)). Especially relevant are (1) all records, results,
and supporting documentation associated with prerequisite programs; (2)
the results and records associated with testing conducted for the
establishment's business customer; and (3) results and records
associated with an establishment's quality control program.
    All of the records generated under the agency's statutory authority
facilitate FSIS surveillance and investigation activities, and the
control and removal of adulterated, misbranded, or otherwise

illegal or unsafe products from commerce. Failure to keep such records
negatively affects consumers' health and FSIS food safety and response
activities (e.g., foodborne illness investigations, product traceback,
product traceforward, and product recall).

C. Considerations for an Effective Product Tracing System

    A ``whole chain'' product tracing system consists of information
elements provided by persons in the supply chain to other persons in
the supply chain or to regulatory officials (e.g., during a traceback
investigation). Key information elements of a ``whole chain'' product
tracing system may include:
     Who manufactured the product,
     Who is sending the product forward in the supply chain and
who is receiving the product,
     Who is transporting product in the supply chain,
     The physical location at which food is received or
released,
     An adequate description of the food that is received or
released,
     The date and time food is received or released,
     A lot or code number (or other identifier of the food),
     The quantity of food and how it is packaged,
     The specific source of each ingredient used to make every
lot of finished product,
     A shipment identifier (such as an invoice number, airway
bill number, or bill of lading, and
     A means to link information about food that is received to
food that is released both internally and externally throughout the
distribution chain.
    A particular information element of a whole chain product tracing
system may be available:
     In records (including internal and external records) that
persons in the supply chain establish and maintain,
     On a label of packaged food (or on the container or
package itself),
     On an individual item of unpackaged food (such as loose
produce), and/or
     On a shipping case containing food.
    The information available in the form of records associated with a
whole chain product tracing system enables an interested person to
identify, and link, at any specific stage of the supply chain, who
manufactured a food product, what specific ingredients are in the
product, where the product came from, where the product was or is,
where the product went, and who transported the product.
    Most product tracing systems (including FDA's regulations in 21 CFR
part 1, subpart J) are designed and implemented as ``one up/one down''
systems rather than as ``whole chain'' systems. In a ``one up/one
down'' system, the focus is on the immediate previous source of food
and the immediate subsequent recipient of food, as well as the
immediate previous transporter and the immediate subsequent
transporter.
    The information available on the label or package\4\ of food has
often been invaluable in enabling FDA to quickly identify the source of
a food implicated in foodborne illness during a traceback investigation
(73 FR 55115 at 55118). Likewise, such information can help FDA or FSIS
to quickly determine the distribution of all identified lots of
contaminated (and potentially contaminated) food during a traceforward
operation. The practical utility of information available on the label
or package of a food during a traceback investigation may be limited in
some circumstances, e.g., if a consumer who became ill after eating a
food product no longer has the package of food. However, information
about when the consumer purchased the product, coupled with information
maintained in records by the person who sold the product to the
consumer, may help to narrow the scope of a traceback investigation.
---------------------------------------------------------------------------

    \4\ Note that 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)).
---------------------------------------------------------------------------

    In section V.A.4 of this document, FDA is seeking comment on
whether some information in product tracing systems should be sent
further in the supply chain than ``one down.''

D. International Product Tracing Systems

    In 2008, FDA described some aspects of international product
tracing systems (73 FR 55115 at 55119). For example:
     In 2006, Codex established principles for tracing food
through production and distribution processes. The Codex principles are
intended to assist government authorities in utilizing product tracing
as a tool within their food inspection and certification system.
     The European Union (EU) requires all food and feed to be
traceable ``one step forward and one step back'' in EU member states.
     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.\5\
---------------------------------------------------------------------------

    \5\ 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.
---------------------------------------------------------------------------

     The GS1 Global Traceability Standard is a business process
standard describing the traceability process independently from the
choice of enabling technologies. It defines minimum requirements for
companies of all sizes across industry sectors and corresponding GS1
Standards used within information management tools.

E. 2008 Public Meetings on Product Tracing Systems for Fresh Produce

    In 2008, FDA held two public meetings to stimulate and focus a
discussion about mechanisms to enhance product tracing systems for
fresh produce intended for human consumption (73 FR 55115). Fresh
produce includes fresh produce that is intact and whole (such as whole
tomatoes), cut during harvest (such as heads of lettuce), or ``fresh-
cut'' (i.e., minimally processed by actions such as peeling, slicing,
or trimming before being packaged for use by the consumer or retail
establishment). Examples of fresh-cut produce are shredded lettuce,
sliced tomatoes, salad mixes, and cut melons. As discussed in the
notice announcing the meetings, traceback investigations for fresh
produce have highlighted several particular challenges associated with
tracing fresh produce back through the supply chain (73 FR 55115 at
55118). For example:
     Fresh produce is perishable and may no longer be available
for testing by the time the outbreak is detected;
     Fresh produce is often sold loose, without any packaging
that would provide information about its source;
     Containers in which the fresh produce was shipped, which
may have provided information about its source, may also have been
discarded by the consumer or end user long before a traceback
investigation is initiated; and
     Common industry practices add a layer of complexity.
Examples of such practices are:
    [cir] Repacking fresh produce from multiple sources;
    [cir] Commingling food from different sources, shipments, or lots;
    [cir] Exchanging food with other local farms or businesses;
    [cir] Re-using and sharing shipment containers from other farms/
businesses;

    [cir] Using different names for the same fresh produce as it
travels throughout the supply chain;\6\
---------------------------------------------------------------------------

    \6\ For example, a tomato may be referred to as a ``red, round
tomato'' early in the supply chain, and be referred to as a ``cooker
tomato'' at a later stage in the supply chain. This type of change
in name reflects the degree of ripeness of the tomato, which varies
over time.
---------------------------------------------------------------------------

    [cir] Substituting a different variety or size of fresh produce
without documentation; and
    [cir] Not assigning a lot or code number (or other identifier of
the food) to the fresh produce that goes forward into the supply chain.
    As also discussed in the notice announcing the 2008 public
meetings, in 2006 there was a multi-state outbreak of illnesses
associated with the consumption of fresh spinach contaminated with E.
coli O157:H7 (73 FR 55115 at 55118). In this situation, the traceback
investigation was facilitated because several consumers who became ill
still had packaged fresh spinach in their refrigerators. This traceback
investigation was greatly facilitated by the information on the label
of the packaged food and on the package itself, including a product
code. Investigators were able to identify the processor through
information required to be on the label of the packaged spinach (21 CFR
101.5(a)) and through a product code the processor had voluntarily
placed on the package. In the early stage of the investigation, the
investigators identified several potentially implicated farms
associated with the production lot of bagged spinach based on the
processor's records. Narrowing to the implicated farms from the
processor records was more time consuming.
    In the notice announcing the meetings (73 FR 55115 at 55120), FDA
asked questions about nine topic areas relating to tracing systems for
fresh produce. FDA received several dozen comments, submitted either
directly to Division of Dockets Management, submitted in writing to
accompany oral testimony provided at the meeting, or presented orally
and captured in the written transcript of the meeting. In addressing
FDA's questions, several comments support the approach recommended by
the Produce Traceability Initiative (Refs. 12 through 14) for case
identification based on GS1 standards for the effective management and
control of supply chains for fresh produce. Information applied to the
shipping case would identify the ``brand owner'' of the fresh produce
in the case as well as various attributes of that fresh produce (such
as what the fresh produce is and a lot number). Comments addressing the
issue of commingling generally express the view that commingling is an
acceptable practice provided there are adequate records documenting the
commingling to enable linking the incoming source and outgoing product.
    Comments generally agree that information in a product tracing
system should be human-readable and, where possible, in electronic
form. However, some comments stress it is more important to have the
information recorded in any form (including paper form) than to require
product tracing records to be electronic. One comment notes that the
common use of day labor, the pressure of productivity, and the
challenges associated with handling perishable items make it difficult
for persons who handle fresh produce to establish and maintain proper
records. Some comments note that purchase records already maintained by
retailers and restaurants (e.g., for accounting purposes) may be useful
for product tracing.
    Several comments mention the use of different product tracing
systems by various persons in the supply chain, and the lack of
interoperability of current systems, as significant barriers to whole-
chain product tracing. Several comments describe products that offer
solutions to some of the logistical challenges associated with tracing
fresh produce. One comment notes that requiring a motor carrier to read
a radio frequency identification (RFID) tag on each crate during the
transportation process could be costly and burdensome to everyone in
the supply chain. Comments generally agree that there would be
significant startup costs associated with any system that uses a
standard format, but that the impact on the industry would vary
depending on an individual company's readiness.
    Several comments both stress the importance of compliance with the
existing requirements of the regulations in 21 CFR part 1, subpart J
and assert that FDA should focus its efforts on enforcing these
existing requirements for product tracing rather than on introducing
new requirements. Some comments acknowledge that FDA's current legal
authority to inspect records under 21 CFR part 1, subpart J is limited
to situations for cause, i.e., when FDA has a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals (Sec.  1.361). Some
of these comments express support for additional legal authority for
FDA to inspect these records to evaluate compliance in addition to
FDA's current legal authority to inspect these records for cause. Some
comments point out that the recordkeeping requirements of the
Perishable Agricultural Commodities Act (PACA) have significance with
respect to product tracing, e.g., that persons (such as handlers of
fresh produce) subject to PACA already capture information that could
be used for tracing purposes.

F. FDA's Activities Since the 2008 Public Meetings on Product Tracing
Systems for Fresh Produce

    In the spring of 2009, FDA engaged in a pilot project, through the
Institute for Food Technologists (IFT) to conduct a mock traceback
scenario on tomatoes with representatives of the industry, academia,
States, and two technology companies. FDA also awarded a 1-year
contract to IFT to review industry practices for product tracing and
identify best practices employed by many different sectors regulated by
FDA. The IFT report is expected to be delivered by November 2009.
    Over the course of the last year, FDA has met extensively with many
industry representatives on their product tracing initiatives as well
as solution providers to gain a better understanding of the practices
and technology available to enhance product tracing for foods. In
addition, FDA has conducted several outreach efforts to share some of
the challenges in traceback and traceforward investigations in
foodborne illness outbreaks.
    In May 2009, FDA provided an update on its efforts related to
produce tracing systems at a joint symposium (``Symposium on Methods
and Systems for Tracking, Tracing, and Verifying Foods'') between the
Food and Environment Research Agency of the EU and the Joint Institute
for Food Safety and Applied Nutrition (JIFSAN, an academic partnership
between FDA and the University of Maryland). FDA is monitoring the
activities of the EU 6th Framework Research programs and various
projects related to traceability. One such program is the EU TRACE
program, which has developed a chain information management system
(TraceCore XML). Another such program is the EU TRACEBACK program,
which is currently developing a system based on micro-devices to
implement food traceability in the food chain. This system will be
pilot tested on two major product chains: Feed/dairy and tomatoes.
    JIFSAN is collaborating with the Iowa State University's IOWA Grain
Quality Initiative to incorporate a generic product traceability module
into JIFSAN's Good Agricultural Practices train-the-trainer program.

G. 2009 Report of the Inspector General

    In 2009, HHS' Office of Inspector General (OIG) issued a report
entitled ``Traceability in the Food Supply Chain'' (Ref. 15). The
purpose of the report was to (1) assess the traceability of selected
food products and (2) determine the extent to which selected food
facilities maintain information required by FDA in a food emergency.
The report noted that not all facilities are required to maintain lot-
specific information in their records, and those that are required to
maintain lot-specific information are required to maintain it only if
it exists. Thus, OIG was able to trace only 5 of the 40 products it
investigated through each stage of the food supply chain.
    For 31 of the other 35 products OIG investigated, OIG could
identify the facilities that likely handled them (Ref. 15). Most
facilities that handled these products did not maintain lot-specific
information in their records and could only estimate a range of
deliveries (from one or more facilities) that may have included the
product OIG purchased. For the remaining four products, OIG could not
even identify the facilities that likely handled them.
    OIG identified several factors that prevented OIG from tracing the
specific products through the food supply chain and observed that these
factors would affect the speed with which FDA can trace specific food
products through the food supply chain. The factors listed by OIG are:
     Manufacturers, processors, and packers, do not always
maintain lot-specific information, as required;
     Other types of facilities do not maintain lot-specific
information because it is not required;
     Retailers receive products not labeled with lot-specific
information; and
     Products are mixed from a large number of farms.

V. Issues and Questions for Discussion for FDA

    FDA welcomes public comments and/or data on the following issues
related to product tracing systems.

A. Core Information Elements of a Product Tracing System

1. Lot Code or Number (or Other Identifier of the Food)
    a. Assigning a lot or code number (or other identifier of the
food). As discussed in section IV.E of this document, the traceback
investigation for a 2006 multi-State outbreak of illnesses associated
with the consumption of fresh spinach contaminated with E. coli O157:H7
was greatly facilitated by the information on the label of a package of
implicated spinach and on the package itself, including a product code.
As also discussed in section IV.G of this document, the HHS OIG has
found that the lack of a lot or code number (or other identifier)
(either because such a number or code was not assigned, or because a
facility either did not assign, or keep a record of, such a number or
code) made it difficult to trace food throughout the supply chain.
    Question 1a. Should a lot or code number (or other identifier of
the food) be assigned to food? If so, at what stage or stages in the
supply chain should it be assigned or modified? For example, should a
lot or code number (or other identifier of the food) be assigned for
all finished food products, whether sold in packaged or unpackaged
form? Should a lot or code number (or other identifier of the food) be
assigned whenever food is manipulated (such as when fresh produce is
commingled, packed, or repacked)?
    Question 1b. What data or information would be useful to include in
a lot or code number (or other identifier of the food)?
    Question 1c. What (if any) procedures should be used to establish a
lot or code number (or other identifier of the food)? Should any such
procedures address the size of a lot or the time frame for production
of a lot (e.g., 21 CFR 113.60(c) provides that codes may be changed on
the basis of one of the following: Intervals of 4 to 5 hours; personnel
shift changes; or batches, as long as the containers that constitute
the batch do not extend over a period of more than one personnel
shift)?
    b. Location of a lot code or number (or other identifier of the
food).
    Question 1d. Should the location of a lot or code number (or other
identifier of the food) depend on the type of food, other factors, or
both?
    Question 1e. Should a lot or code number (or other identifier of
the food) be located:
     On the label (or container or package) of a packaged food?
     On the shipping container of packaged food, unpackaged
food, or both?
     In internal records (such as receiving records, batch
production records, inventory records, and distribution lists)?
     In external records accompanying commercial transactions
(such as a bill of lading, airway bill, invoice, manifest, shipping
record, or packing list)?
    Question 1f. What ways might the lot or code number (or other
identifier of the food) be linked to internal and external records
associated with the food?
2. Information Elements Not Already Required in 21 CFR Part 1, Subpart
J
    Records accompanying commercial transactions or documenting
delivery or receipt of a product in commerce (such as a bill of lading,
airway bill, invoice, shipping/receiving record, and packing list)
contain product tracing information. For example, such records identify
who is sending a product forward in the supply chain, who is receiving
the product, what the product is, and how much of the product there
is.\7\ In some cases, such records also identify the lot or code number
(or other identifier of the food). Many of these records have their own
identifier, e.g., an invoice number, airway bill number, or a bill of
lading number. It may be efficient to associate product tracing
information with a ``shipment identifier,'' such as an invoice number,
airway bill number, bill of lading, or some other identifier
established by the shipper. For example, a firm that is sending product
forward in the supply chain may retain some information (such as a lot
or code number or other identifier of the food) in an internal
inventory record and other information (such as the immediate
subsequent recipient of the product) in shipping and distribution
records. Including the shipment identifier in all of these records may
help to link the records, particularly when records are in electronic
form and can be searched using electronic means.
---------------------------------------------------------------------------

    \7\ Note that Sec.  1.352(a), (b), and (c) provide three
options, each using slightly different terminology, for transporters
to satisfy the recordkeeping requirements. For the purpose of the
discussion here, FDA uses generic terms associated with the
information element rather than the specific terms used in Sec.
1.352(a), (b), and/or (c).
---------------------------------------------------------------------------

    Question 2a. Should a shipment identifier be considered an
information element of an enhanced product tracing system? If so, are
there any business practices (e.g. the way shipments are currently
identified) that would be impacted?
    Question 2b. Should any other information not already required by
Sec. Sec.  1.337 and 1.345 be considered an information element of an
enhanced product tracing system?
3. Information Elements on the Package of a Packaged Food and/or on the
Shipping Case
    Question 3a. Should product tracing information not currently
required to be on the package of a packaged food or on

a shipping case be present on the package or shipping case?
    Question 3b. If so, what additional product tracing information
should be present on the package or shipping case?
    Question 3c. If so, at what stage or stages in the supply chain
should such information be included?
    Question 3d. If so, should such information be present for all
food, or only some food?
4. Information Elements Transmitted Beyond ``One Up/One Down''
    Question 4a. Should some information about fresh produce (such as
information identifying the name and physical location of any farm,
packer or repacker that provided, processed, or packed fresh produce)
be sent forward farther in the supply chain than ``one down''? If so,
how far in the supply chain should such information go? For example,
should such information be transmitted as far as the retail
establishment that sells the fresh produce to consumers, or as far as
the last person in the supply chain before the retail establishment?
    Question 4b. Should some information about packaged food\8\ (such
as information identifying the manufacturer of a processed food) be
sent forward farther in the supply chain than ``one down''? If so, how
far in the supply chain should such information go? For example, should
such information be transmitted as far as the retail establishment that
sells the food to consumers, or as far as the last person in the supply
chain before the retail establishment?
---------------------------------------------------------------------------

    \8\ Note that packaged produce is within the scope of both
Question 4a and Question 4b.
---------------------------------------------------------------------------

5. Standardized Information Elements
    The lack of standardization in the information in current product
tracing systems can delay traceback investigations and traceforward
operations largely due to the need to interpret and clarify information
elements between varying product tracing systems and the lack of
systems to link information elements.
    Question 5a. What (if any) information elements in an enhanced
product tracing system should be standardized? Are there specific
information elements (such as a shipment identifier and a lot or code
number (or other identifier of the food)) that are particularly
amenable to standardization? Would such standardization be specific to
a specific industry sector or type of food (e.g., fresh produce, frozen
seafood, milk, baked goods, breakfast cereal) or could it apply across
industry sectors or types of food?
    Question 5b. What standards already exist and how useful are they
for product tracing?
    Question 5c. If standards can and should be used for certain
information elements in an enhanced product tracing system, should FDA
develop the standards?
    Question 5d. Would current or newly developed standards for the
content and format of electronic systems have practical utility for
persons who continue to use paper-based records? For example, could
human-readable data that supports standardized electronic data be
useful to persons who continue to use paper-based records?

B. Records

1. Record of the Lot or Control Number (or Other Identifier of the
Food)
    FDA's regulations in 21 CFR part 1, subpart J require persons who
manufacture, process, or pack food to keep records on the lot or code
number or other identifier of the food received from the nontransporter
and transporter immediate previous sources of food, or released to the
nontransporter and transporter immediate subsequent recipients of food,
to the extent this information exists (Sec. Sec.  1.337(a)(4) and
1.345(a)(4)). These regulations do not require persons who do not
manufacture, process, or pack food to keep records on the lot or code
number or other identifier of the food.
    Question 6a. Would it be useful for persons, in addition to those
who manufacture, process or pack food, to establish and maintain a
record of a lot or code number (or other identifier of the food)? If
so, for which persons (e.g., distributors, retailers) would it be
useful?
    Question 6b. If it would be useful for some persons, in addition to
those who manufacture, process, or pack food, to establish and maintain
a record of a lot or code number (or other identifier of the food),
would it be equally useful irrespective of the type of food (e.g.,
packaged food or fresh produce)?
2. Records to Facilitate Linkage
    FDA's regulations in 21 CFR part 1, subpart J also require records
kept by nontransporters to identify the immediate subsequent
nontransporter and transporter recipients of food to include
information reasonably available to the nontransporter to identify the
specific source of each ingredient used to make every lot of finished
product (Sec.  1.345(b)). In essence, a record containing such
information is a ``linking record,'' because it links a specific lot of
released food to specific lots of ingredient. FDA's regulations in 21
CFR part 1, subpart J have no corresponding requirement (under Sec.
1.337) for a ``linking record'' that would link a specific lot of an
incoming ingredient to all released food containing that specific lot
of ingredient.
    Question 7a. Would it be useful for nontransporters who
manufacture, process, or pack food to establish and retain any
additional records to facilitate linkage? In particular, would it be
useful for persons who manufacture, process, or pack food to establish
and maintain a ``linking record'' that would link a specific lot of an
incoming ingredient to all released food containing that specific lot
of ingredient?
    Question 7b. If so, should some or all of these records be created
at the time of receipt or release of food or be existing records, or
should some or all of these records be new records created upon the
request of FDA (e.g., during an outbreak investigation or traceforward
operation)?
    Question 7c. If so, would it be useful for FDA to specify the
format of the record? For example, should FDA provide a model form that
could be used to provide the information in such a record? Or would it
be more useful for FDA only to specify the information elements of such
a record?
    Question 7d. If so, should all such records be in electronic form?
3. Records That Are Both Electronic and Human-Readable
    As noted (see section IV.E of this document), comments to the 2008
notice of meeting on product tracing for fresh produce recommend that
information in a product tracing system should be human-readable.
Human-readable information would enable all persons in the supply chain
to have access to the information. These comments also recommend that
information in a product tracing system should, where possible, be in
electronic form. Electronic systems could make it faster and easier to
accurately record information, such as a lot or code number (or other
identifier of the food) and link incoming with outgoing product and
thus speed the course of a traceback investigation or traceforward
operation. For example, a person making a paper record of a human-
readable code 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 would be greatly reduced if
the code is recorded using an automatic system, such as a bar code or
RFID.
    However, some persons may not have access to electronic
technologies, particularly if the technology (such as the use of bar
codes or RFID) requires an initial investment. Some persons may be
reluctant to select a particular electronic technology if there is no
industry standard for which electronic technology to use.
    Question 8. Should some or all product tracing records be
established and maintained in electronic form? If so, should
information established and maintained in electronic form also be
human-readable?
4. Mechanisms to Make Product Tracing Information Available to FDA
    Question 9a. What can be done to speed the process whereby persons
who have product information relevant to a traceback investigation
provide the information to FDA? For example, should some information be
sent to FDA, rather than have FDA travel to a facility that has the
information?
    Question 9b. If information would be sent to FDA, how should it be
transmitted? For example, could the information be transmitted by e-
mail, fax, or courier service (e.g., by overnight delivery)? Or should
there be an electronic portal (such as the portal FDA developed for the
Reportable Food Registry)?

C. Role of Risk in Developing an Enhanced Product Tracing System

    Question 10. Should any or all enhancements to current product
tracing systems apply regardless of risk, or should such enhancements
be based on risk? If based on risk, what criteria should be used to
determine risk? If not based on risk, should such enhancements be
developed or phased in based on risk?

D. Costs, Benefits, and Feasibility of Implementing an Enhanced Product
Tracing System

    Further enhancing the product tracing system for food could aid FDA
in shortening the duration of outbreaks and limiting the number of
people who become ill. It could also give FDA more information to use
in preventing future outbreaks. However, net public health benefits
from enhancements to current product tracing systems may vary by food
category depending on the level of risk. The net public health benefits
may also vary by the type and size of entity along the supply chain
that would be covered by the enhanced product tracing systems. FDA
recognizes that enhancing product tracing for food may not be just a
matter of keeping more or different records or adding more information
to product or packaging, but also a matter of changing business
practices.
    Question 11a. What are the costs, benefits and feasibility of
implementing an enhanced product tracing system for each of the persons
in the supply chain for various segments of the food industry?
    Question 11b. To what extent would an enhanced product tracing
system affect current business practices? What would be the cost of any
such changes in current business practices for each link in the supply
chain?
    Question 11c. What determines the costs for food distributors and
retailers to maintain records of lot code information for manufactured
products, and farm-related information for fresh produce?
    Question 11d. What determines the costs for small food retailers to
maintain records consistent with the BT regulations, as well as lot
code information for manufactured and processed food products, and
farm-related information for fresh produce?
    Question 11e. What determines the costs for food service
establishments to maintain records consistent with the BT regulations,
as well as lot code information for manufactured or processed food
products and farm-related information for fresh produce?
    Question 11f. What determines the size of a lot of manufactured or
processed food products and how do lot sizes vary by food category and
size of the manufacturer?
    Question 11g. What determines the costs for maintaining ``linking''
records for manufacturers?

E. Outreach

    Shortly after the establishment of the product tracing requirements
in 21 CFR part 1, subpart J, FDA held a series of public meetings to
provide information on the rule to the public and to provide the public
an opportunity to ask questions of clarification (69 FR 71655, December
9, 2004). Regardless of such outreach, the HHS OIG report (Ref. 15)
noted that manufacturers, processors, and packers do not always
maintain lot-specific information, as required.
    Question 12a. What, if any, additional outreach from FDA would
better enable manufacturers, processors, and packers to comply with the
requirements to maintain records of the lot or code number (or other
identifier) to the extent this information exists?
    Question 12b. What, if any, additional outreach from FDA would
better enable all persons subject to 21 CFR part 1, subpart J to better
comply with its requirements?

VI. Issues and Questions for Discussion for FSIS

    To address the specific causes of foodborne illness outbreaks
associated with FSIS-regulated products, FSIS needs to develop a
strategy to investigate and document them, and take enforcement action
against firms for violations of FSIS' laws and regulations that impact
public health. FSIS must also be able to fully investigate these
complaints and reports of foodborne illness. With regard to
investigations associated with ground beef consumption, product lot
coding and beef manufacturing plant information are required to
successfully conduct product traceback. In many circumstances, however,
investigators are only provided with purchase information (e.g., date
and location of purchase, type of ground beef). Investigators must then
rely heavily on grinding records kept in retail stores, meat markets,
and other operations to gather the information needed to undertake
traceback actions. Unfortunately, investigators frequently find these
grinding records to be incomplete because of missing or inaccurate
information, thereby preventing the traceback of potentially
adulterated products, which could result in additional illnesses.
    FSIS is seeking comment on the following:

A. Core Information Elements of a Product Tracing System

1. Lot Code or Number (or Other Identifier of the Food)
    With respect to the traceback and traceforward of ground beef, how
can FSIS ensure that it will be able to obtain the following types of
information from operations that grind beef:
     Production codes
     Total pounds ground with the same final label
     All source materials (such as full names and product codes
of all source products used to formulate each lot of store ground
product; Federal or State establishment numbers; sell-by, use-by, or
other production date codes; use of bench trim and its source) used in
each lot
     Special instructions or disclaimer statements on source
material
     Other products ground from the same source

2. Standardized Information Elements
     Should FSIS focus on standardizing product codes?
     Would current or newly developed standards for the content
and format of electronic systems have practical utility for persons who
continue to use paper-based records? For example, could human-readable
data that supports standardized electronic data be useful to persons
who continue to use paper-based records?

B. Role of Risk in Developing Regulations

     Should any or all enhancements to product tracing systems
apply regardless of risk, or should such enhancements be based on risk?
    [cir] If based on risk, what criteria should be used to determine
risk?
    [cir] If not based on risk, should enhancements to product tracing
systems be developed or phased in based on risk?
     The need for adequate ground beef grinding records is
based on risk. Should FSIS wait for other specific items to become
public health issues or should FSIS use a broader approach and include
all amenable product?
     Should FSIS be concerned about ready-to-eat product or
focus on raw product?
     Should FSIS look at heat-treated, not fully cooked
products?
    [cir] Does formulation impact heat-treated, not fully cooked
products to the extent that FSIS needs to traceback the source material
or should FSIS focus more on the processing practices and labeling?

VII. 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 are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

VIII. Additional Public Notification

    Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that all
persons, including minorities, women, and persons with disabilities are
aware of this document, FSIS will announce it online through the FSIS
Web page located at http://www.fsis.usda.gov/regulations_&_policies/
2009_Notices_Index/index.asp. FSIS will also make copies of this
Federal Register publication available through the FSIS Constituent
Update, which is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, recalls, and other types of information that could affect or
would be of interest to constituents and stakeholders. The Update is
communicated via Listserv, a free electronic mail subscription service
for industry, trade and farm groups, consumer interest groups, health
professionals, and other individuals who have asked to be included. The
Update is available on the FSIS Web page. Through the Listserv and the
Web page, FSIS is able to provide information to a much broader and
more diverse audience. In addition, FSIS offers an e-mail subscription
service that provides automatic and customized access to selected food
safety news and information. This service is available at http://
www.fsis.usda.gov/news_and_events/email_subscription/. Options range
from recalls to export information to regulations, directives, and
notices. Customers can add or delete subscriptions themselves, and have
the option to password-protect their accounts.

IX. References

    FDA has placed the following references on display in FDA's
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. 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/download/standards/10603/CXG_060e.pdf.
Accessed and printed on July 21, 2009.
    2. CDC. 2009. Multistate Outbreak of Salmonella Infections
Associated with Peanut Butter and Peanut Butter-Containing
Products--United States, 2008-2009. Morbidity and Mortality Weekly
Reports, vol. 58, No. 4, pp. 85-90. Available at http://www.cdc.gov/
mmwr/preview/mmwrhtml/mm58e0129a1.htm. Accessed and printed on April
26, 2009.
    3. FDA. 2009. Peanut Butter and other Peanut Containing Products
Recall List. Information current as of 12 PM June 12, 2009. 3916
Entries in List. Available at http://www.accessdata.fda.gov/scripts/
peanutbutterrecall/index.cfm.
    4. FDA. 2009. Pistachios and other Pistachio Containing Products
Recall List. Information current as of 12 noon June 23, 2009. 664
Entries in List. Available at http://www.accessdata.fda.gov/scripts/
pistachiorecall/index.cfm.
    5. FDA. 2009. Plainview Milk Cooperative Ingredient Recall
Product List. Information current as of noon July 17, 2009. 272
Entries in List. Available at http://www.accessdata.fda.gov/scripts/
Milk/.
    6. FDA. 2008. Melamine Contaminated Pet Foods--2007 Recall List.
Information current as of June 25, 2008. http://
www.accessdata.fda.gov/scripts/petfoodrecall/index.cfm.
    7. FSIS. 2007. FSIS Recall Release FSIS-RC-040-2007, 10/6/2007.
Updated: New Jersey Firm Expands Recall Of Ground Beef Products Due
To Possible E. Coli O157:H7 Contamination.
    8. FDA. 2004. What You Need to Know About Establishment and
Maintenance of Records. Available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodDefenseandEmergencyResponse/ucm113822.htm.
    9. FDA. 2006. Questions and Answers Regarding Establishment and
Maintenance of Records. Edition 4. Available at http://www.fda.gov/
Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodDefenseandEmergencyResponse/ucm062801.htm.
    10. FDA. 2008. Statement of David Acheson, M.D., F.R.C.P.,
Associate Commissioner for Foods, Food and Drug Administration,
Before the Committee on Agriculture, Subcommittee on Horticulture
and Organic Agriculture, United States House of Representatives,
July 30, 2008. Available at http://www.fda.gov/NewsEvents/Testimony/
ucm096397.htm.
    11. FDA. 2009. Guidance for Industry: Questions and Answers
Regarding the Reportable Food Registry as Established by the Food
and Drug Administration Amendments Act of 2007. Available at http://
www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/FoodSafety/ucm180761.htm.
    12. 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.
    13. 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.
    14. 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.
    15. Daniel R. Levinson, Inspector General, Department of Health
and Human Services,

Office of Inspector General. 2009. Traceability in the Food Supply
Chain. March 2009. OEI-02-06-00210. Available at http://oig.hhs.gov/
oei/reports/oei-02-06-00210.pdf. Accessed and printed July 20, 2009.

    Dated: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26479 Filed 11-2-09; 8:45 am]

BILLING CODE 4160-01-S