Product Tracing Systems for Food; Public Meeting, 56843-56855 [E9-26479]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56843-56855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26479]


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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

[[Page 56844]]

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, 202-690-6498, e-mail: 
Sheila.Johnson@fsis.usda.gov.
    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, 202-720-8609.
    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, 301-436-1731, toll-free FAX: 1-877-366-3322, e-mail: 
Juanita.Yates@fda.hhs.gov.

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
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                                           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.
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[[Page 56845]]

 
Advance      December 2,  We encourage   https://        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 https://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 https://
 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,  https://        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 https://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-

[[Page 56846]]

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

[[Page 56847]]

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,

[[Page 56848]]

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

[[Page 56849]]

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)).
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    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\
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    \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 https://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;

[[Page 56850]]

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

[[Page 56851]]

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.
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    \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).
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    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

[[Page 56852]]

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?