Product Tracing Systems for Fresh Produce; Public Meetings, 55115-55122 [E8-22430]
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Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–22437 Filed 9–23–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0513]
Product Tracing Systems for Fresh
Produce; Public Meetings
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
two public meetings regarding product
tracing systems for fresh produce. The
purpose of the meetings is to stimulate
and focus a discussion about
mechanisms to enhance product tracing
systems for fresh produce and to
improve FDA’s ability to use the
information in such systems to identify
the source of contamination associated
with fresh produce-related outbreaks of
foodborne illness. This discussion will
help FDA determine what short and
long term steps we should take to
enhance the current tracing system.
DATES: See ‘‘How to Participate in the
Meetings’’ in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: See ‘‘How to Participate in
the Meetings’’ in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For
registration, requests to make an oral
presentation, and submission of written
material for the presentation: Deborah
Harris, EDJ Associates, Inc., 11300
Rockville Pike, suite 1001, Rockville,
MD 20852, 240–221–4326, FAX: 301–
945–4295, e-mail:
dharris@edjassociates.com.
For general questions about the
meeting, to request onsite parking for
55115
the October 16 meeting, or for special
accommodations due to a disability:
Juanita Yates, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration (HFS–009), 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1731, e-mail:
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. How to Participate in the Meetings
Stakeholders will have an opportunity
to provide oral comments. Due to
limited space and time, we encourage
all persons who wish to attend one or
both of the meetings, including those
requesting an opportunity to make an
oral presentation at one or both of the
meetings, to register in advance.
Depending on the number of oral
presentations, we may need to limit the
time of each oral presentation (e.g., 5
minutes each). If time permits FDA may
grant requests for an opportunity to
make a presentation from individuals or
organizations that did not register in
advance.
Table 1 of this document provides
information on participation in the
meetings and on submitting comments.
TABLE 1.
Date
Address
October 16,
2008, from 9
a.m. to 5 p.m.
Harvey W. Wiley Federal
Building, Food and Drug
Administration, Center for
Food Safety and Applied
Nutrition, 5100 Paint
Branch Pkwy., College
Park, MD 20740-3835
(Metro stop: College Park
on the Green Line)
Advance registration
October 8, 2008
We encourage you to use
electronic registration if
possible.1
Make a request for
oral presentation
October 1, 2008
Provide a brief description of the oral
presentation and
any written material
for the presentation
October 8, 2008
Request special accommodations due
to a disability
October 8, 2008
See FOR FURTHER INFORMATION CONTACT
Request onsite parking
October 10, 2008
See FOR FURTHER INFORMATION CONTACT
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First Public Meeting
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Electronic Address
Other Information
https://www.cfsan.
fda.gov/register.html
Registration information, information on
requests to make an oral presentation,
and written material associated with
an oral presentation may be posted
without change to https://
www.regulations.gov, including any
personal information provided.
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Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices
TABLE 1.—Continued
Date
Address
November 13,
2008, from 9
a.m. to 5 p.m.
Ronald V. Dellums Federal
Building, Edward Roybal
Auditorium, 1301 Clay St.,
3d floor, Oakland, CA
94612
Advance registration
October 30, 2008
We encourage you to use
electronic registration if
possible.1
Make a request for
oral presentation
October 23, 2008
Provide a brief description of the oral
presentation and
any written material
for the presentation
October 30, 2008
Request special accommodations due
to a disability
October 30, 2008
See FOR FURTHER INFORMATION CONTACT
January 22, 2009
Division of Dockets Management (HFA–305), Food
and Drug Administration,
5630 Fishers Lane rm.
1061, Rockville, MD 20852
Second Public Meeting
Submit comments
Electronic Address
Other Information
https://www.cfsan.
fda.gov/register.html
Registration information, information on
requests to make an oral presentation,
and written material associated with
an oral presentation may be posted
without change to https://
www.regulations.gov, including any
personal information provided.
https://
www.regulations.gov
All comments should be identified with
the docket number found in brackets
in the heading of this document. For
additional information on submitting
comments, see section IV of this document.
1 You may also register by mail, fax, e-mail, or phone by providing registration information (including name, title, firm name, address, telephone
number, fax number, and e-mail address), requests to make an oral presentation, and written material for the presentation to the contact person
for registration (see FOR FURTHER INFORMATION CONTACT).
II. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at 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.
III. Background
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A. Introduction
Food can become contaminated at
many different steps in the farm-to-table
continuum—on the farm; in packing,
processing, or distribution facilities;
during storage or transit; at retail
establishments; in restaurants; and in
the home. In recent years, FDA has done
a great deal to prevent both deliberate
and unintentional contamination of
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food at each of these steps. FDA has
worked with other Federal, State, local,
tribal, and foreign counterpart food
safety agencies, as well as with law
enforcement agencies, intelligencegathering agencies, industry, and
academia, to significantly strengthen the
Nation’s food safety and food defense
systems across the entire distribution
chain. This cooperative work has
resulted in a greater awareness of
potential vulnerabilities, the creation of
more effective prevention programs,
new surveillance systems, and the
ability to respond more quickly to
outbreaks of foodborne illness. (An
‘‘outbreak’’ is the occurrence of two or
more cases of a similar illness resulting
from the ingestion of a common food.)
However, changes in consumer
preferences, changes in industry
practices, and the rising volume of
imports continue to pose significant
challenges for the agency, particularly
with respect to fresh produce. Outbreaks
involving various types of fresh fruit
and vegetables have led to thousands of
confirmed illnesses in recent years (72
FR 8750, February 27, 2007, and Ref. 1),
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and many more unconfirmed or
unreported illnesses.
When an outbreak of foodborne
illness occurs, quick action is critical to
prevent additional illness. The Centers
for Disease Control and Prevention
(CDC) of the U.S. Department of Health
and Human Services, and State, local,
and/or tribal health departments
conduct epidemiologic investigations to
identify the possible food(s) involved in
an outbreak. After CDC and/or the State/
local/tribal entity notify FDA that a
specific food is implicated, FDA reviews
and evaluates the epidemiologic data
and assesses other potential causes for
the outbreak (e.g., food worker illness,
environmental contamination). Based
on FDA’s review and evaluation, an
investigation to trace back the
implicated food may be initiated to
identify the source of the food and,
potentially, of the contamination.
Working with industry and with other
domestic and, in some cases foreign,
government agencies, FDA inspects or
investigates points throughout the
supply chain to determine where the
contamination is likely to have
occurred. Tracing food through a supply
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chain may require us to find and
examine products, packaging, and
documentation (such as bills of lading,
invoices, and other records maintained
by the firm).
The ability to quickly identify the
source of a contaminated product, and
the path the product traveled between
production and consumption, is critical
to responding effectively to ongoing
outbreaks of foodborne illness. Timely
and accurate information gained from
an investigation of the source of
produce implicated in an outbreak of
foodborne illness (traceback
investigation) may:
• Help limit the public health impact
of a foodborne illness outbreak, for
example, by more quickly removing the
contaminated produce from the market;
• Enable public health authorities
and the food industry to provide
targeted and accurate information about
affected food to consumers and, as a
result, restore or enhance consumer
confidence in produce safety; and
• Help limit the source of the
problem to a particular region or locality
so that firms or regions that are not
connected to the contaminated food are
not adversely affected by a foodborne
illness outbreak or the investigation of
an outbreak.
In addition, the identification of
sources of contaminated products may
prevent future outbreaks by helping
FDA and the food industry to identify
and eliminate conditions that may have
resulted in the food becoming
contaminated and by helping them to
understand better how the food became
contaminated, so that the lessons
learned can be used to prevent
contamination in the future.
When an outbreak occurs, it also is
critical that we be able to act quickly to
take steps to prevent further illness.
FDA may attempt to document the
distribution of all implicated lots of
food (traceforward operation) once the
source of an outbreak is known to
ensure that all contaminated food in
commerce is removed from the market.
Traceback investigations and
traceforward operations are components
of a ‘‘product tracing’’ system. As
defined by the Codex Alimentarius
Commission (Codex),1 traceability/
product tracing is the ability to follow
the movement of a food through
1 The Codex Alimentarius Commission was
formed in 1963 by the Food and Agriculture
Organization and the World Health Organization of
the United Nations to develop food standards,
guidelines, and related texts such as codes of
practice, and is recognized under the World Trade
Organization Agreement on the Application of
Sanitary and Phytosanitary Measures as the
international standards organization for food safety.
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specified stage(s) of production,
processing, and distribution (Ref. 2).
Traceback investigations involving
fresh produce are among the most
challenging investigations we face
because the food is perishable and may
no longer be available for testing by the
time we conduct our investigation. In
addition, fresh produce is often sold
loose, without any packaging that would
provide information about its source.
Further, cases in which the produce was
shipped, which may have provided
such information, may also have been
discarded by the time a traceback
investigation is initiated. Industry
practices, such as repacking produce
from multiple sources, using different
names for the same fresh produce as it
travels throughout the supply chain,
and not assigning specific identifiers to
the produce, can complicate our
traceback investigations even further.
We have had some recent successes in
quickly identifying the source of an
outbreak, but in some situations efforts
to identify the source of the outbreak
have proven difficult or impossible. We
have learned that we need to be able to
respond to the increased size and
complexity of the fresh produce supply
chain with a traceback capacity that is
likewise more sophisticated, effective,
and efficient and that reflects and
responds to changing production and
distribution patterns.
We are holding the public meetings to
stimulate and focus a discussion about
mechanisms to enhance product tracing
systems for fresh produce and to
improve FDA’s ability to use the
information in such systems to identify
the source of contamination associated
with fresh produce-related outbreaks of
foodborne illness.
B. Information Elements Available in
Current Product Tracing Systems
A product tracing system consists of
information elements provided by
parties in the supply chain. In general,
this information is available in the form
of records that parties in the supply
chain establish and maintain apart from
the produce. Some of this information
may also be present on packaged food
or on shipping cases of food items such
as loose produce; some information
applied to loose produce (e.g., on a
sticker) may also provide information
related to product tracing.
In the context of a foodborne illness
outbreak, the information available
through a product tracing system should
enable an interested party (such as a
party in the supply chain or a public
health agency conducting a traceback
investigation) to identify, at any specific
stage of the supply chain, where the
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fresh produce came from, where the
fresh produce was or is (e.g., in
situations where a party in the supply
chain has the fresh produce in its
possession), where the fresh produce
went, and who transported the fresh
produce. This is commonly known as a
‘‘one up/one down’’ or ‘‘one step back/
one step forward’’ system. In general,
records that are part of such a system
fall into one of two categories: Paperbased, human-readable records; or
technology-based records with
automated data capture (e.g., via bar
codes or radiofrequency identification
(RFID)), which may or may not also be
human-readable.
To facilitate product tracing, FDA’s
regulations, at 21 CFR part 1, subpart J,
‘‘Establishment, Maintenance, and
Availability of Records,’’ impose ‘‘one
up/one down’’ recordkeeping
requirements on certain persons who
manufacture, process, pack, transport,
distribute, receive, hold, or import food
in the United States. The regulations
identify the information that must be
established and maintained, how long it
must be maintained, and how quickly it
must be available to FDA. This
information includes where the food
product came from and where it went.
A detailed discussion of those
requirements is beyond the scope of this
document, which does not address
compliance with the recordkeeping
regulations.2
Other product information, relevant to
some traceback investigations, is
available on the product label of
packaged foods. For example, section
403(e)(1) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 343(e))
provides that a food in package form is
misbranded unless it bears a label
containing the name and place of
business of the manufacturer, packer, or
distributor. As another example, section
403(i)(1) of the act provides that a food
is misbranded unless its label bears the
common or usual name of the food, if
there is one. Our regulations
implementing these provisions are in
part 101 (21 CFR part 101). However,
under our labeling regulations, the term
‘‘package’’ does not include shipping
containers or wrappings used solely for
the transportation of such commodities
in bulk or in quantity to manufacturers,
packers, processors, or wholesale or
retail distributors (see 21 CFR 1.20(a)).
2 For more information on the recordkeeping
regulations, see ‘‘What You Need to Know About
Establishment and Maintenance of Records’’ (Ref. 3)
and ‘‘Questions and Answers Regarding
Establishment and Maintenance of Records’’ (Ref.
4).
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C. Structural and Geographic
Characteristics of the Fresh Produce
Industry Relevant to Product Tracing
Systems
The fresh produce industry is
particularly diverse, both structurally
and geographically (Ref. 6). Structurally,
the industry varies not only by
commodity, region, and season, but also
by distributor and retailer. For example,
as discussed later in this section, parties
in the supply chain may use one or
more suppliers for the same type of
fresh produce depending on factors
including growing season, demand, and
the variability of different harvests in
different locations.
Geographically, more than 55 billion
pounds of fresh produce are grown
within the United States annually, and
more than 26 billion pounds of fresh
produce are imported into the United
States every year from 58 countries (Ref.
7). These 81 billion pounds of produce
often travel hundreds or thousands of
miles on the way to consumers (usually
in shipments of 10,000 pounds or much
less), and change hands several times
between different points in the complex
supply chain (Ref. 7). The nature and
complexity of the global produce market
raise special challenges for public
health agencies, and even those within
the industry, to be able to trace the path
of a particular product throughout the
supply chain.
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D. Challenges Associated with
Traceback Investigations of Fresh
Produce
The supply chain for a given type of
fresh produce may be very complex. For
example, several growers might supply
their produce to a packer or distributor,
and there may be multiple distributors
who receive the product before its sale
to or use by the ultimate consumer.
Growers may send their produce to
several packers or distributors, and
suppliers may obtain produce from
several packers or distributors as well as
directly from growers. Parties in the
supply chain may be within the United
States or abroad; thus, produce might be
imported into or exported from any
point in the supply chain one or more
times. Other parties in a food supply
chain may include processors of fresh
produce, who may chill it, cut it into
smaller pieces, or combine pieces of
fresh produce with other foods to make
another food product (such as using
lettuce to make a salad). Contamination
can occur at almost any point in the
fresh produce supply chain.
In some fresh produce supply chains,
produce from multiple sources may be
combined or commingled during
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packing or processing operations. This
practice can complicate or even frustrate
efforts to trace fresh produce throughout
the supply chain. For example, a
packing firm may buy a particular type
of vegetable from multiple farms, and
then sort the vegetables by size, color,
quality, or some other attribute before
packing into containers. As another
example, a large truck may collect loose
produce from multiple farms and then
deliver the collected loose produce to a
single processor or distributor. Even if
we could trace a contaminated product
back to the processor or distributor, or,
in the second example, back to the
packing firm, the commingling of loose
produce before it reaches the processor
or distributor or at the packing firm
makes it difficult or impossible to
distinguish which farm is the source of
the contaminated produce. The
complexity increases if the truck
delivers the loose produce to more than
one processor or distributor.
An additional challenge associated
with a traceback investigation for fresh
produce is that the produce may not
always retain the same description as it
moves through the supply chain. For
example, one party in the supply chain
may describe its fresh produce as ‘‘red
round tomatoes,’’ while the next party
in the supply chain may describe the
same fresh produce as ‘‘cooker
tomatoes.’’ Different descriptions for the
same produce can make it very difficult
or impossible to determine whether two
records refer to the same or different
products or shipments.
Another challenge associated with a
traceback investigation for fresh
produce is that there may be no
identifier on the produce, its package, or
its case, and in associated records.
Moreover, there currently is no
industry-wide or sector-wide
standardization of the information
captured in the documentation. This
lack of standardization makes it difficult
and time-consuming to cross-reference
information currently available in
product tracing systems.
E. How Has Product Tracing
Information Available in Records and
on Product Packages/Containers Helped
Us During Traceback Investigations?
In the following paragraphs, we
describe how we used product tracing
information to conduct two recent
traceback investigations—one involving
a nonperishable packaged food, and one
involving a perishable packaged food.
The information available to us
included information available in
records established and maintained by
parties in the supply chain and
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information available on packages or
containers of the packaged food.
• In February 2007, CDC notified
FDA of a multi-State outbreak of
Salmonella Tennessee infections
associated with the consumption of
peanut butter. Peanut butter is a
nonperishable packaged food, sold in
jars. Consumers who became ill had
open jars of peanut butter available for
testing. Investigators were able to test
samples of peanut butter taken from the
jars and confirm the presence of
Salmonella Tennessee in the peanut
butter. Investigators were able to
identify the manufacturer through
information required to be on the label
of the jars (§ 101.5(a)) and through a
product code the manufacturer had
voluntarily placed on the jars. This
information made it possible for FDA to
visit the manufacturing facility the day
after we learned of the outbreak from
CDC. Investigators were able to use the
product code to look in the
manufacturing facility for unopened jars
of peanut butter manufactured at the
same time as the jars available from
consumers. Investigators took samples
of peanut butter from these unopened
jars and confirmed the presence of
Salmonella Tennessee in those samples.
Investigators uncovered conditions at
the manufacturer’s facility that were
likely to have caused the contamination
and obtained a positive environmental
sample so there was no need to further
trace the peanuts back to the farm. Our
traceback investigation was facilitated
because the implicated food was a
nonperishable, packaged food that was
available to investigators and contained
information about the source of the
implicated food on the product
container.
• In September 2006, CDC informed
FDA of a multi-State outbreak of
illnesses associated with the
consumption of fresh spinach
contaminated with E. coli O157:H7.
Fresh spinach is a perishable food that
may not remain in consumers’ homes
after consumers become ill and CDC
finds an association between the illness
and the food. However, in this situation
the spinach was sold in a package. The
traceback investigation was facilitated
because several consumers who became
ill still had packages of fresh spinach in
their refrigerators. As with the peanut
butter, investigators were able to
identify the processor through
information required to be on the label
of the packaged spinach (§ 101.5(a)) and
through a product code the processor
had voluntarily placed on the package.
By looking at the processor’s records,
the investigators were able to identify
the implicated farms associated with the
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identified production lot of bagged
spinach. This traceback investigation
was more complex than the
investigation for the peanut butter,
because it required traceback beyond
the processor to the farms. However, as
with the peanut butter, the traceback
investigation was greatly facilitated by
the information on the label of the
packaged food and on the package itself.
F. Industry Product Tracing Systems
That Are in Use or Under Development
in the United States
1. Commodity-Specific Efforts
Various recordkeeping and other
practices designed to enhance product
tracing systems are already carried out
by industry within the food supply
chain. For instance, to better monitor
food safety practices of growers, the
California cantaloupe industry has
incorporated product tracing
requirements that involve maintaining
information such as packing date, field,
and packing crew as part of their State
marketing order (Ref. 9).
Similarly, the California Tomato
Farmers cooperative has instituted
documentation requirements in its
membership agreement with growers to
facilitate one up/one down tracking and
product tracing. The documentation of
packed tomatoes must include
information about the source (i.e.,
grower, production location, lot
identification, personnel/crew involved
in the harvest of the product) and about
the customer receiving the product. A
system to track and trace tomatoes back
to supply source and forward to
customers must be developed and tested
annually (Ref. 10).
Stakeholders have developed
commodity-specific food safety
guidelines for the entire supply chain
for three commodities: Melons (Ref. 11),
tomatoes (Ref. 8), and lettuce and leafy
greens (Ref. 12).
label and other food products to have
their factories certified against one of
the internationally-recognized Global
Food Safety Initiative (GFSI) standards
(Ref. 13). The GFSI standard for
traceability requires the supplier to
develop and maintain appropriate
procedures and systems to ensure (1)
identification of any out-sourced
product, ingredient, or service; (2)
complete records of batches of inprocess or final product and packaging
throughout the production process; and
(3) record of purchaser and delivery
destination for all product supplied
(Ref. 14).
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2. Buyer-Led Initiatives
3. Produce Traceability Initiative (PTI)
In October 2007, the Produce
Marketing Association (PMA), the
United Fresh Produce Association
(UFPA), and the Canadian Produce
Marketing Association (CPMA) initiated
the joint PTI (Ref. 15). The PTI now
includes more than 50 companies,
including distributors, grower-shippers,
and retailers. A principal objective of
the PTI is to drive adoption of
consistent ‘‘traceability best practices’’
throughout the produce supply chain
from ‘‘field to fork.’’ In pursuing the
goal of broad adoption of tracking and
product tracing standards and practices,
the PTI has established a timeline for a
series of milestones for recording,
tracking, and product tracing data on
produce shipments. These milestones
include establishing company prefixes;
establishing an identification number
for location; assigning global trade item
numbers (GTINs) to produce cases;
showing GTINs, lot numbers, and
packing/harvesting dates on each case;
encoding this information in bar codes;
and reading and storing the information
at each point in the supply chain. The
PTI also calls for tracking and product
tracing standards to be adopted at the
case level initially, followed by
standards for item-level coding (Refs. 5
and 16).
Large food retailers, such as
supermarket chains, have become more
active in ensuring the safety of the food
products they purchase. One example of
this is the increasing use of independent
third-party food safety audits of grower
and shipper operations to verify
compliance with good agricultural and
manufacturing practices. These
practices generally include
requirements that the grower or shipper
maintain records that facilitate the
tracing of product produced, handled,
or processed in order to pass an audit.
For example, in February 2008, WalMart, Inc., became the first U.S. grocery
chain to require suppliers of its private
G. International Product Tracing
Systems
Some countries have mandatory
product tracing systems in place in
various forms, although these systems
are more prevalent with respect to
animal identification than for food in
general. The European Union (EU), in
addition to having a mandatory product
tracing system for animals, also requires
a product tracing system for all food and
feed businesses. Specifically, the EU
requires all food and feed to be traceable
‘‘one step forward and one step back’’ in
EU member states. Food and feed
business operators must be able to
document where a particular food or
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feed product came from and where it is
going next. Specifically, they must be
able to document the names and
addresses of suppliers and customers, as
well as the nature of the product and
date of delivery. They are also
encouraged to keep information on the
volume and quantity of a product; the
batch number, if one exists; and a more
detailed description of the product,
such as whether it is fresh or processed.
Food and feed business operators must
also have systems and procedures that
allow them to provide this information
to the competent authorities on demand.
In addition to these general
requirements, sector-specific
requirements apply to certain categories
of food products (fruit and vegetables,
beef, fish, honey, olive oil) (Refs. 17
through 20). In 2007, the EU began a 4year study to develop, test, and evaluate
two full pilot product tracing systems—
one for the tomato food chain and the
other for the feed/dairy chain (Ref. 21).
In 2006, Codex established principles
for tracing food through production and
distribution processes (Ref. 2). The
Codex principles are intended to assist
government authorities in utilizing
product tracing as a tool within their
food inspection and certification
system.
Certain private international standard
setting organizations have also
developed principles and other
guidelines on product tracing systems
for use by industry. For example, in
2007 the International Standards
Organization (ISO) issued ISO
22005:2007, which provides general
principles and basic requirements for
designing and implementing a product
tracing system along a food processor’s
supply chain.3 Another example is the
GS1 Global Traceability Standard (Ref.
22), which is being used by the PMA,
CPMA, UFPA, and other associations
involved in the PTI.
H. Actions Suggested by Stakeholders
Some consumer advocacy groups
have asked us to develop and
implement emergency regulations that
would require source tracing for
produce (farm-to-table); written food
safety plans for farmers, processors, and
packinghouses; and tighter controls on
repacking (Ref. 23). Some industry trade
associations have asked FDA and CDC
to convene a meeting with industry
representatives and work together to
minimize the human and economic
impact of an outbreak (Ref. 24). These
3 ISO 22005:2007. ‘‘Traceability in the feed and
food chain—General principles and basic
requirements for system design and
implementation.’’ July 2007. Available for purchase
at https://webstore.ansi.org.
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trade associations urged FDA and CDC
to work in partnership with industry to
find solutions to speed up and
streamline outbreak identification and
response. These trade associations also
recommended that a working group be
established to look at crisis management
systems and that teams of industry
experts be established to help in
traceback investigations.
I. Issues and Questions for Discussion
As previously noted, we need to
increase the speed and accuracy of
traceback investigations to help limit
the public health impact of a foodborne
illness outbreak; to limit to a particular
region, locality, farm(s), or processor(s)
the source of the problem (where the
source is in fact limited), so that an
entire industry is not unnecessarily
affected; to enable public health
authorities and the food industry to
provide targeted and accurate
information about affected food to
consumers; to institute steps to correct
the source of contamination; and, as a
result, to restore or enhance consumer
confidence in produce safety.
We intend the public meetings to
stimulate and focus a discussion about
mechanisms to enhance product tracing
systems for fresh produce and to
improve FDA’s ability to use the
information in such systems to identify
the source of contamination associated
with fresh produce-related outbreaks of
foodborne illness. This discussion will
help FDA determine what short and
long term steps, such as issuing
regulations, we should take to enhance
the current tracing system. Aspects of
these measures could require new legal
authority. We welcome public
comments and/or data on the following
issues related to product tracing systems
for fresh produce:
1. Should a ‘‘fresh produce identifier’’
be assigned to fresh produce? If so, at
what stage or stages in the supply chain
should such an identifier be assigned or
modified? What data or information
would be useful to include in such an
identifier? Should the identifier be
placed on the fresh produce, the
package, the shipping container, and/or
the invoice or bill of lading? Should the
location of the identifier depend on the
type of produce or on other factors?
Our investigations of the 2006
outbreak associated with packaged fresh
spinach and the 2007 outbreak
associated with peanut butter were
greatly facilitated by a product ‘‘code’’
that the party who packaged the
implicated product had assigned to the
packaged product. We seek comment on
whether a ‘‘fresh produce identifier’’
should be assigned to fresh produce,
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and, if so, at what stage or stages in the
supply chain and with what information
elements.
2. What other data or information
would be useful on the invoice or bill
of lading, fresh produce, package, or
shipping case? At what stage or stages
in the supply chain should such data or
information be included?
The product ‘‘codes’’ assigned to the
packaged fresh spinach associated with
the 2006 outbreak and to the peanut
butter associated with the 2007 outbreak
were present on the packaged products.
We seek comment on whether any other
data or information (in addition to or
instead of the fresh produce identifier
discussed in question 1) should be on or
attached to the invoice, bill of lading,
fresh produce, its package (when
feasible), or the shipping case.
3. Should an enhanced product
tracing system extend to all fresh
produce? If not, what criteria should be
used to determine coverage?
There are a number of factors that
may increase or decrease the risk for
contamination of produce. Such factors
may include crop characteristics (e.g.,
proximity of the edible portion of the
crop to the soil, or rough surface, such
as cantaloupe); production practices or
conditions (e.g., water quality for field
and packing operations); method of
irrigation; likelihood of animal
intrusion; and worker health and
hygiene. Should these or other factors
(e.g., history of outbreaks) be considered
in prioritizing the development and
application of an enhanced product
tracing system?
4. Should fresh produce be
commingled? If commingling is
unavoidable, what practices should an
enhanced product tracing system
include to ensure that fresh produce can
be traced effectively and efficiently?
Some industry food safety guidelines
advise against commingling (Ref. 8).
Should parties in the supply chain for
some or all commodities consider
refining or designing their product
tracing systems so that they can identify
the source of individual pieces of fresh
produce if they combine or commingle
produce from multiple sources and link
this information to the one-up/onedown records they establish and
maintain? If such identification is not
feasible, should parties in the supply
chain for some or all commodities
consider no longer combining or
commingling produce? We seek
comment on any measures already in
place to address product tracing of
commingled fresh produce and the
extent to which such measures have
been demonstrated to be successful in
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ensuring product tracing, particularly
during traceback investigations.
5. What should be the scope of an
enhanced product tracing system for
fresh produce?
As stated previously, the supply chain
for fresh produce is often complex. We
seek comment concerning how an
enhanced product tracing system for
fresh produce should apply to various
parties in the supply chain, including
producers, packers, distributors, and
retailers. More specifically, we seek
comment on whether some or all
aspects of an enhanced product tracing
system for fresh produce should apply
to some or all farms. For example, if a
fresh produce identifier includes
information about the date of harvest,
the farm is the party who would have
that information. It may be more
practical for the farm to identify the date
of harvest on the invoice when it ships
the fresh produce than for the first party
in the supply chain to subsequently
contact the farm to determine the date
of harvest.
We also seek comment on whether
some or all aspects of an enhanced
product tracing system for fresh produce
should apply to some or all restaurants
or retailers. For example, if a ‘‘fresh
produce identifier’’ is assigned to
produce a restaurant receives, we seek
comment on whether the restaurant
could establish and maintain records of
that identifier or could retain the
invoice or bill of lading if the
information is contained on those
documents.
We also seek comment on whether
some or all aspects of an enhanced
product tracing system for fresh produce
should extend to consumers. Product
tracing systems currently used by the
fresh produce industry typically do not
reach the consumer level. However,
some segments of the supply chain can
and do record some individual
consumer information, and may be able
to use this information to alert specific
consumers about product recalls or for
other purposes. For example, a retailer
who has a ‘‘frequent customer’’ or
‘‘bonus card’’ program may record each
cardholder’s purchases. The retailer’s
consumer purchasing information also
would be very helpful in those
situations where the fresh produce that
is possibly linked to a foodborne illness
outbreak is eaten and the consumers
have disposed of any identifiers on the
fresh produce before a traceback
investigation begins. Could such
systems be adapted or modified to
provide assistance with traceback
investigations? Would there be any
issues or concerns associated with such
systems?
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6. Should the data or information in
an enhanced product tracing system be
human-readable, technology-based, or
both? If technology-based, what
technology should be used?
‘‘Human-readable’’ information
should enable all parties in the supply
chain, regardless of the technology used,
to read this information. By ‘‘humanreadable,’’ we mean information
consisting of numbers and/or letters
capable of being read by the human eye.
Technology-based systems could make
it faster and easier to accurately record
information such as a fresh produce
identifier. For example, a person making
a paper record of a human-readable
identifier expressed in numbers or
letters may mistakenly transpose or omit
numbers or letters, thus creating
erroneous entries in the records. In
contrast, the potential for such mistakes
is greatly reduced if the identifier is
recorded using an automatic system
such as a bar code or RFID. In addition,
technology-based systems could greatly
speed a traceback investigation.
However, some parties may not have
access to electronic technologies. We
seek comment on whether data or
information in an enhanced product
tracing system should be humanreadable, technology-based, or both. If
technology-based, what technology
should be used?
7. What (if any) data or information in
an enhanced product tracing system
should be standardized?
The lack of standardization in the
information in current product tracing
systems can frustrate traceback
investigations. We seek comment on
whether the various segments of the
fresh produce industry should develop
standards for the content and format of
records, particularly of electronic
records that could help make electronic
record systems interoperable. We seek
comment on the existence and utility of
existing standards relevant to some or
all of the information elements that
would be in an enhanced product
tracing system, such as in a fresh
produce identifier. We also seek
comment on whether such standards
should be developed and on whether
current or newly developed standards
should be identified in any guidance or
regulations issued by FDA. We also seek
comment on whether and how current
or newly developed standards for the
content and format of electronic systems
could have practical utility for parties
who continue to use paper-based
technology. For example, could humanreadable data that support standardized
technology-based data be useful to
parties who continue to use paper-based
technology?
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8. What are the costs, benefits, and
feasibility of implementing an enhanced
product tracing system?
Further enhancing the product tracing
system for fresh produce could aid us in
shortening the duration of outbreaks
and limiting the number of people who
become ill. It could also give us more
information to use in preventing future
outbreaks. However, these benefits will
not come equally from all types of fresh
produce. Enhancing the product tracing
system beyond current practices and
requirements for certain types of fresh
produce might not significantly enhance
public health if the fresh produce has
not been associated with foodborne
illness or any known risk factors. An
enhanced fresh product tracing system
for fresh produce may also impose
burdens on entities in the supply chain.
We seek comment on the costs, benefits,
and feasibility of implementing an
enhanced product tracing system for
each of the parties in the supply chain.
We recognize that enhancing product
tracing of fresh produce may not be just
a matter of keeping more or different
records or adding more information to
product or packaging, but also of
changing business practices. We request
comment on the extent to which an
enhanced product tracing system for
fresh produce will affect comingling and
repacking of produce and the cost of any
such changes in the supply chain.
9. Would enhancing FDA’s role in
developing and implementing effective
product tracing systems for fresh
produce, through increased regulation,
guidance, or additional legal authorities,
improve the effectiveness of traceback
investigations and traceforward
operations? What mandatory and
voluntary measures would be most
effective in achieving the goal of
enhancing product tracing systems for
fresh produce and improving FDA’s
ability to use the information in such
systems to identify the source of
contamination associated with fresh
produce-related outbreaks of foodborne
illness? How would these measures help
FDA work better with industry and
other stakeholders during traceback
investigations and traceforward
operations?
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
table 1 of this document) written or
electronic comments for consideration
at or after the meeting in addition to, or
in place of, a request for an opportunity
to make an oral presentation. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
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55121
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
V. References
We have placed the following
references on display in the Division of
Dockets Management (see table 1 of this
document). You may see them between
9 a.m. and 4 p.m., Monday through
Friday. (FDA has verified the Web site
addresses, but FDA is not responsible
for any subsequent changes to Web sites
after this document publishes in the
Federal Register.)
1. U.S. Food and Drug Administration,
1996–2007 Produce Outbreaks (unpublished
compilation).
2. Codex Alimentarius Commission. 2006.
Principles for Traceability/Product Tracing
As a Tool Within A Food Inspection and
Certification System. CAC/GL60–2006.
Available at https://
www.codexalimentarius.net/web/
standard_list.do?lang=en. Accessed and
printed on July 18, 2008.
3. U.S. Food and Drug Administration.
2004. ‘‘What You Need to Know About
Establishment and Maintenance of Records.’’
Available at https://www.cfsan.fda.gov/
~acrobat/fsbtrec.pdf.
4. U.S. Food and Drug Administration.
‘‘Questions and Answers Regarding
Establishment and Maintenance of Records.
Edition 4.’’ Available at https://
www.cfsan.fda.gov/~dms/recguid4.html.
5. Produce Marketing Association and
Canadian Produce Marketing Association.
2006. Fresh Produce Traceability. A Guide
To Implementation. Available at https://
www.pma.com/cig/tech/traceability.cfm.
Accessed and printed on June 18, 2008.
6. Roberta Cook, ‘‘The U.S. Fresh Produce
Industry: An Industry in Transition,’’ in
Postharvest Technology of Horticultural
Crops (Adel Kader ed., 2001).
7. U.S. Department of Agriculture,
Agricultural Marketing Service. Issued
February 2006. Fresh Fruit and Vegetable
Shipments By Commodities, States, and
Months. FVAS–4 Calendar Year 2005.
Available at https://www.ams.usda.gov.
Accessed and printed on July 22, 2008.
8. North American Tomato Trade Work
Group. 2008. Commodity Specific Food
Safety Guidelines for the Fresh Tomato
Supply Chain, Edition 2. Available at https://
www.californiatomatofarmers.com/pdfs/
TomatoGuidelinesJuly08.pdf. Accessed and
printed on September 11, 2008.
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Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices
9. U.S. Department of Agriculture,
Economic Research Service (Golan, E.,
Krissoff B., Kuchler F., Nelson K., Price G.).
2004. Agricultural Economic Report No. 830.
‘‘Traceability in the U.S. Food Supply:
Economic Theory and Industry Studies,’’ p.
17 (p. 25 of the electronic document).
Available at https://www.ers.usda.gov/
publications/aer830/aer830.pdf. Accessed
and printed on August 4, 2008.
10. California Tomato Farmers. Food Safety
Program. Available at https://
www.californiatomatofarmers.com/
foodsafety.asp. Accessed and printed on
August 4, 2008.
11. Produce Industry Food Safety Initiative
co-sponsored by the Produce Marketing
Association and the United Fresh Fruit and
Vegetable Association. 2005. Commodity
Specific Food Safety Guidelines for the
Melon Supply Chain. 1st Edition. Available
at https://www.cfsan.fda.gov/~dms/
melonsup.html. Accessed and printed on
August 7, 2008.
12. International Fresh-cut Produce
Association, Produce Marketing Association,
United Fresh Fruit and Vegetable
Association, and Western Growers. 2006.
Commodity Specific Food Safety Guidelines
for the Lettuce and Leafy Greens Supply
Chain. 1st Edition. Available at https://
www.cfsan.fda.gov/~dms/lettsup.html.
Accessed and printed on August 7, 2008.
13. Wal-Mart, Inc., press release, February
4, 2008. Available at https://
walmartstores.com/FactsNews/NewsRoom/
7918.aspx. Accessed and printed on August
29, 2008.
14. Global Food Safety Initiative, GFSI
Guidance Document, 5th Edition, September
2007. Available at https://www.ciesnet.com/
pfiles/programmes/foodsafety/
GFSI_Guidance_Document_5th%20Edition
%20_September%202007.pdf. Accessed and
printed on September 4, 2008.
15. Produce Marketing Association,
Canadian Produce Marketing Association,
and United Fresh Produce Association. 2007.
Joint Release. Available at https://
www.cpma.ca/pdf/IndustryTech/
Traceability_Joint_Release_
PMA_CPMA_UFPA_Oct2007.pdf. Accessed
and printed on July 22, 2008.
16. CPMA/PMA Traceability Task Force.
Traceability Best Practices. Fresh Produce
Industry (North America). Available at https://
www.cpma.ca/pdf/IndustryTech/
TraceabilityBestPractices.pdf. Accessed and
printed on July 18, 2008.
17. U.S. Government Accounting Office.
2008. Report to Congressional Requestors.
Food Safety. Selected Countries Can Offer
Insights into Ensuring Import Safety and
Responding to Foodborne Illness. GAO 08–
794. Available at https://www.gao.gov/
new.items/d08794.pdf. Accessed and printed
on July 18, 2008.
18. European Commission. Health and
Consumer Protection Directorate General.
2007 Factsheet. Food Traceability. Available
at https://ec.europa.eu/food/food/foodlaw/
traceability/factsheet_trace_2007_en.pdf.
Accessed and printed on July 20, 2008.
19. Standing Committee On The Food
Chain And Animal Health. Guidance On The
Implementation Of Articles 11, 12, 16, 17, 18,
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19 AND 20 of Regulation (EC) N° 178/2002
on General Food Law. Available at https://
ec.europa.eu/food/food/foodlaw/guidance/
guidance_rev_7_en.pdf. Accessed and
printed on September 3, 2008.
20. Commission of the European
Communities, ‘‘Commission Regulation (EC)
No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying
down the general principles and
requirements of food law, establishing the
European Food Safety Authority and laying
down procedures in matters of food safety.’’
Official Journal of the European Union,
1.2.2002 L31/1–L31/24, 2002. Available at
https://eur-lex.europa.eu/pri/en/oj/dat/2002/
l_031/l_03120020201en00010024.pdf.
Accessed and printed on July 22, 2008.
21. Traceback—Keeping Track of the Food
Trail. Available at ftp://ftp.cordis.europa.eu/
pub/food/docs/traceback.pdf. Accessed and
printed on July 24, 2008.
22. GS1 Global Traceability Standard.
Available at https://www.gs1.org/
productssolutions/traceability/. Accessed
and printed on July 18, 2008.
23. Letter dated July 3, 2008 from Michael
F. Jacobson and Caroline Smith de Waal of
the Center for Science in the Public Interest
and Chris Waldrop of the Consumer
Federation of America to Andrew C. von
Eschenbach of the U.S. Food and Drug
Administration. Available at https://
cspinet.org/new/pdf/von_eshenbach
_traceability_letter.pdf. Accessed and printed
on July 19, 2008.
24. Letter dated July 3, 2008, from Thomas
E. Stenzel of United Fresh Produce
Association and Bryan Silbermann of
Produce Marketing Association to Secretary
Michael O. Leavitt of the U.S. Department of
Health and Human Services. Available at
https://www.unitedfresh.org/assets/files/
PMA_UFPA_2nd_HHS_Meeting_
Request_7308.pdf. Accessed and printed on
July 21, 2008.
Dated: September 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22430 Filed 9–19–08; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service Background
Investigations of Individuals in
Positions Involving Regular Contact
With or Control Over Indian Children,
OPM–306
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
60 days for public comment on
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proposed information collection
projects, the Indian Health Service (IHS)
is publishing for comment a summary of
a proposed information collection to be
submitted to the Office of Management
and Budget (OMB) for review.
Proposed Collection: Title: 0917–
0028, ‘‘IHS Background Investigations of
Individuals in Positions Involving
Regular Contact With or Control Over
Indian Children, OPM–306. Type of
Information Collection Request:
Extension, without revision, of currently
approved information collection, 0917–
0028, ‘‘IHS Background Investigations of
Individuals in Positions Involving
Regular Contact With or Control Over
Indian Children, OPM–306.
Form Number: OPM–306. Forms:
Declaration for Federal Employment.
Need and Use of Information Collection:
This is a request for approval of
collection information required by
Section 408 of the Indian Child
Protection and Family Violence
Prevention Act, Public Law 101–630,
104 Stat. 4544, and 25 U.S.C. 3201–
3211. The IHS is required to compile a
list of all authorized positions within
the IRS where the duties and
responsibilities involve regular contact
with, or control over, Indian children;
and to conduct an investigation of the
character of each individual who is
employed, or is being considered for
employment in a position having
regular contact with, or control over,
Indian children. Section 3207(b) of the
Indian Child Protection and Family
Violence Prevention Act was amended
by Section 814 of U.S.C. 3031, the
Native American Laws Technical
Corrections Act of 2000, which requires
that the regulations prescribing the
minimum standards of character ensure
that none of the individuals appointed
to positions involving regular contact
with, or control over Indian children
have been found guilty of, or entered a
plea of nolo contendere or guilty to any
felonious offense, or any of two or more
misdemeanor offenses under Federal,
State, or Tribal law involving crimes of
violence; sexual assault, molestation,
exploitation, contact or prostitution;
crimes against persons; or offenses
committed against children. In addition,
42 U.S.C. 13041 requires each agency of
the Federal Government, and every
facility operated by the Federal
Government (or operated under contract
with the Federal Government), that
hires (or contracts for hire) individuals
involved with children under the age of
18 or child care services to assure that
all existing and newly hired employees
undergo a criminal history background
check. The background is to be initiated
through the personnel program of the
E:\FR\FM\24SEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 186 (Wednesday, September 24, 2008)]
[Notices]
[Pages 55115-55122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22430]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0513]
Product Tracing Systems for Fresh Produce; Public Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing two
public meetings regarding product tracing systems for fresh produce.
The purpose of the meetings is to stimulate and focus a discussion
about mechanisms to enhance product tracing systems for fresh produce
and to improve FDA's ability to use the information in such systems to
identify the source of contamination associated with fresh produce-
related outbreaks of foodborne illness. This discussion will help FDA
determine what short and long term steps we should take to enhance the
current tracing system.
DATES: See ``How to Participate in the Meetings'' in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: See ``How to Participate in the Meetings'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For registration, requests to make an
oral presentation, and submission of written material for the
presentation: Deborah Harris, EDJ Associates, Inc., 11300 Rockville
Pike, suite 1001, Rockville, MD 20852, 240-221-4326, FAX: 301-945-4295,
e-mail: dharris@edjassociates.com.
For general questions about the meeting, to request onsite parking
for the October 16 meeting, or for special accommodations due to a
disability: Juanita Yates, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-009), 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-1731, e-mail:
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. How to Participate in the Meetings
Stakeholders will have an opportunity to provide oral comments. Due
to limited space and time, we encourage all persons who wish to attend
one or both of the meetings, including those requesting an opportunity
to make an oral presentation at one or both of the meetings, to
register in advance. Depending on the number of oral presentations, we
may need to limit the time of each oral presentation (e.g., 5 minutes
each). If time permits FDA may grant requests for an opportunity to
make a presentation from individuals or organizations that did not
register in advance.
Table 1 of this document provides information on participation in
the meetings and on submitting comments.
Table 1.
----------------------------------------------------------------------------------------------------------------
Date Address Electronic Address Other Information
----------------------------------------------------------------------------------------------------------------
First Public October 16, Harvey W. Wiley ................... ............................
Meeting 2008, from 9 Federal Building,
a.m. to 5 p.m. Food and Drug
Administration,
Center for Food
Safety and Applied
Nutrition, 5100 Paint
Branch Pkwy., College
Park, MD 20740-3835
(Metro stop: College
Park on the Green
Line)
----------------------------------------------------------------------------------------------------------------
Advance October 8, 2008 We encourage you to https://www.cfsan. Registration information,
registration use electronic fda.gov/ information on requests to
registration if register.html make an oral presentation,
possible.\1\ and written material
associated with an oral
presentation may be posted
without change to https://
www.regulations.gov,
including any personal
information provided.
--------------------------------------
Make a request October 1, 2008 ...................... ................... ............................
for oral
presentation
--------------------------------------
Provide a brief October 8, 2008 ...................... ................... ............................
description of
the oral
presentation and
any written
material for the
presentation
----------------------------------------------------------------------------------------------------------------
Request special October 8, 2008 See FOR FURTHER ................... ............................
accommodations INFORMATION CONTACT
due to a
disability
----------------------------------------------------------------------------------------------------------------
Request onsite October 10, 2008 See FOR FURTHER ................... ............................
parking INFORMATION CONTACT
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[[Page 55116]]
Second Public November 13, Ronald V. Dellums ................... ............................
Meeting 2008, from 9 Federal Building,
a.m. to 5 p.m. Edward Roybal
Auditorium, 1301 Clay
St., 3d floor,
Oakland, CA 94612
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Advance October 30, 2008 We encourage you to https://www.cfsan. Registration information,
registration use electronic fda.gov/ information on requests to
registration if register.html make an oral presentation,
possible.\1\ and written material
associated with an oral
presentation may be posted
without change to https://
www.regulations.gov,
including any personal
information provided.
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Make a request October 23, 2008 ...................... ................... ............................
for oral
presentation
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Provide a brief October 30, 2008 ...................... ................... ............................
description of
the oral
presentation and
any written
material for the
presentation
----------------------------------------------------------------------------------------------------------------
Request special October 30, 2008 See FOR FURTHER ................... ............................
accommodations INFORMATION CONTACT
due to a
disability
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Submit comments January 22, 2009 Division of Dockets https:// All comments should be
Management (HFA-305), www.regulations.go identified with the docket
Food and Drug v number found in brackets in
Administration, 5630 the heading of this
Fishers Lane rm. document. For additional
1061, Rockville, MD information on submitting
20852 comments, see section IV of
this document.
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\1\ You may also register by mail, fax, e-mail, or phone by providing registration information (including name,
title, firm name, address, telephone number, fax number, and e-mail address), requests to make an oral
presentation, and written material for the presentation to the contact person for registration (see FOR
FURTHER INFORMATION CONTACT).
II. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at 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.
III. Background
A. Introduction
Food can become contaminated at many different steps in the farm-
to-table continuum--on the farm; in packing, processing, or
distribution facilities; during storage or transit; at retail
establishments; in restaurants; and in the home. In recent years, FDA
has done a great deal to prevent both deliberate and unintentional
contamination of food at each of these steps. FDA has worked with other
Federal, State, local, tribal, and foreign counterpart food safety
agencies, as well as with law enforcement agencies, intelligence-
gathering agencies, industry, and academia, to significantly strengthen
the Nation's food safety and food defense systems across the entire
distribution chain. This cooperative work has resulted in a greater
awareness of potential vulnerabilities, the creation of more effective
prevention programs, new surveillance systems, and the ability to
respond more quickly to outbreaks of foodborne illness. (An
``outbreak'' is the occurrence of two or more cases of a similar
illness resulting from the ingestion of a common food.) However,
changes in consumer preferences, changes in industry practices, and the
rising volume of imports continue to pose significant challenges for
the agency, particularly with respect to fresh produce. Outbreaks
involving various types of fresh fruit and vegetables have led to
thousands of confirmed illnesses in recent years (72 FR 8750, February
27, 2007, and Ref. 1), and many more unconfirmed or unreported
illnesses.
When an outbreak of foodborne illness occurs, quick action is
critical to prevent additional illness. The Centers for Disease Control
and Prevention (CDC) of the U.S. Department of Health and Human
Services, and State, local, and/or tribal health departments conduct
epidemiologic investigations to identify the possible food(s) involved
in an outbreak. After CDC and/or the State/local/tribal entity notify
FDA that a specific food is implicated, FDA reviews and evaluates the
epidemiologic data and assesses other potential causes for the outbreak
(e.g., food worker illness, environmental contamination). Based on
FDA's review and evaluation, an investigation to trace back the
implicated food may be initiated to identify the source of the food
and, potentially, of the contamination. Working with industry and with
other domestic and, in some cases foreign, government agencies, FDA
inspects or investigates points throughout the supply chain to
determine where the contamination is likely to have occurred. Tracing
food through a supply
[[Page 55117]]
chain may require us to find and examine products, packaging, and
documentation (such as bills of lading, invoices, and other records
maintained by the firm).
The ability to quickly identify the source of a contaminated
product, and the path the product traveled between production and
consumption, is critical to responding effectively to ongoing outbreaks
of foodborne illness. Timely and accurate information gained from an
investigation of the source of produce implicated in an outbreak of
foodborne illness (traceback investigation) may:
Help limit the public health impact of a foodborne illness
outbreak, for example, by more quickly removing the contaminated
produce from the market;
Enable public health authorities and the food industry to
provide targeted and accurate information about affected food to
consumers and, as a result, restore or enhance consumer confidence in
produce safety; and
Help limit the source of the problem to a particular
region or locality so that firms or regions that are not connected to
the contaminated food are not adversely affected by a foodborne illness
outbreak or the investigation of an outbreak.
In addition, the identification of sources of contaminated products
may prevent future outbreaks by helping FDA and the food industry to
identify and eliminate conditions that may have resulted in the food
becoming contaminated and by helping them to understand better how the
food became contaminated, so that the lessons learned can be used to
prevent contamination in the future.
When an outbreak occurs, it also is critical that we be able to act
quickly to take steps to prevent further illness. FDA may attempt to
document the distribution of all implicated lots of food (traceforward
operation) once the source of an outbreak is known to ensure that all
contaminated food in commerce is removed from the market. Traceback
investigations and traceforward operations are components of a
``product tracing'' system. As defined by the Codex Alimentarius
Commission (Codex),\1\ traceability/product tracing is the ability to
follow the movement of a food through specified stage(s) of production,
processing, and distribution (Ref. 2).
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\1\ The Codex Alimentarius Commission was formed in 1963 by the
Food and Agriculture Organization and the World Health Organization
of the United Nations to develop food standards, guidelines, and
related texts such as codes of practice, and is recognized under the
World Trade Organization Agreement on the Application of Sanitary
and Phytosanitary Measures as the international standards
organization for food safety.
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Traceback investigations involving fresh produce are among the most
challenging investigations we face because the food is perishable and
may no longer be available for testing by the time we conduct our
investigation. In addition, fresh produce is often sold loose, without
any packaging that would provide information about its source. Further,
cases in which the produce was shipped, which may have provided such
information, may also have been discarded by the time a traceback
investigation is initiated. Industry practices, such as repacking
produce from multiple sources, using different names for the same fresh
produce as it travels throughout the supply chain, and not assigning
specific identifiers to the produce, can complicate our traceback
investigations even further.
We have had some recent successes in quickly identifying the source
of an outbreak, but in some situations efforts to identify the source
of the outbreak have proven difficult or impossible. We have learned
that we need to be able to respond to the increased size and complexity
of the fresh produce supply chain with a traceback capacity that is
likewise more sophisticated, effective, and efficient and that reflects
and responds to changing production and distribution patterns.
We are holding the public meetings to stimulate and focus a
discussion about mechanisms to enhance product tracing systems for
fresh produce and to improve FDA's ability to use the information in
such systems to identify the source of contamination associated with
fresh produce-related outbreaks of foodborne illness.
B. Information Elements Available in Current Product Tracing Systems
A product tracing system consists of information elements provided
by parties in the supply chain. In general, this information is
available in the form of records that parties in the supply chain
establish and maintain apart from the produce. Some of this information
may also be present on packaged food or on shipping cases of food items
such as loose produce; some information applied to loose produce (e.g.,
on a sticker) may also provide information related to product tracing.
In the context of a foodborne illness outbreak, the information
available through a product tracing system should enable an interested
party (such as a party in the supply chain or a public health agency
conducting a traceback investigation) to identify, at any specific
stage of the supply chain, where the fresh produce came from, where the
fresh produce was or is (e.g., in situations where a party in the
supply chain has the fresh produce in its possession), where the fresh
produce went, and who transported the fresh produce. This is commonly
known as a ``one up/one down'' or ``one step back/one step forward''
system. In general, records that are part of such a system fall into
one of two categories: Paper-based, human-readable records; or
technology-based records with automated data capture (e.g., via bar
codes or radiofrequency identification (RFID)), which may or may not
also be human-readable.
To facilitate product tracing, FDA's regulations, at 21 CFR part 1,
subpart J, ``Establishment, Maintenance, and Availability of Records,''
impose ``one up/one down'' recordkeeping requirements on certain
persons who manufacture, process, pack, transport, distribute, receive,
hold, or import food in the United States. The regulations identify the
information that must be established and maintained, how long it must
be maintained, and how quickly it must be available to FDA. This
information includes where the food product came from and where it
went. A detailed discussion of those requirements is beyond the scope
of this document, which does not address compliance with the
recordkeeping regulations.\2\
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\2\ For more information on the recordkeeping regulations, see
``What You Need to Know About Establishment and Maintenance of
Records'' (Ref. 3) and ``Questions and Answers Regarding
Establishment and Maintenance of Records'' (Ref. 4).
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Other product information, relevant to some traceback
investigations, is available on the product label of packaged foods.
For example, section 403(e)(1) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 343(e)) provides that a food in package form
is misbranded unless it bears a label containing the name and place of
business of the manufacturer, packer, or distributor. As another
example, section 403(i)(1) of the act provides that a food is
misbranded unless its label bears the common or usual name of the food,
if there is one. Our regulations implementing these provisions are in
part 101 (21 CFR part 101). However, under our labeling regulations,
the term ``package'' does not include shipping containers or wrappings
used solely for the transportation of such commodities in bulk or in
quantity to manufacturers, packers, processors, or wholesale or retail
distributors (see 21 CFR 1.20(a)).
[[Page 55118]]
C. Structural and Geographic Characteristics of the Fresh Produce
Industry Relevant to Product Tracing Systems
The fresh produce industry is particularly diverse, both
structurally and geographically (Ref. 6). Structurally, the industry
varies not only by commodity, region, and season, but also by
distributor and retailer. For example, as discussed later in this
section, parties in the supply chain may use one or more suppliers for
the same type of fresh produce depending on factors including growing
season, demand, and the variability of different harvests in different
locations.
Geographically, more than 55 billion pounds of fresh produce are
grown within the United States annually, and more than 26 billion
pounds of fresh produce are imported into the United States every year
from 58 countries (Ref. 7). These 81 billion pounds of produce often
travel hundreds or thousands of miles on the way to consumers (usually
in shipments of 10,000 pounds or much less), and change hands several
times between different points in the complex supply chain (Ref. 7).
The nature and complexity of the global produce market raise special
challenges for public health agencies, and even those within the
industry, to be able to trace the path of a particular product
throughout the supply chain.
D. Challenges Associated with Traceback Investigations of Fresh Produce
The supply chain for a given type of fresh produce may be very
complex. For example, several growers might supply their produce to a
packer or distributor, and there may be multiple distributors who
receive the product before its sale to or use by the ultimate consumer.
Growers may send their produce to several packers or distributors, and
suppliers may obtain produce from several packers or distributors as
well as directly from growers. Parties in the supply chain may be
within the United States or abroad; thus, produce might be imported
into or exported from any point in the supply chain one or more times.
Other parties in a food supply chain may include processors of fresh
produce, who may chill it, cut it into smaller pieces, or combine
pieces of fresh produce with other foods to make another food product
(such as using lettuce to make a salad). Contamination can occur at
almost any point in the fresh produce supply chain.
In some fresh produce supply chains, produce from multiple sources
may be combined or commingled during packing or processing operations.
This practice can complicate or even frustrate efforts to trace fresh
produce throughout the supply chain. For example, a packing firm may
buy a particular type of vegetable from multiple farms, and then sort
the vegetables by size, color, quality, or some other attribute before
packing into containers. As another example, a large truck may collect
loose produce from multiple farms and then deliver the collected loose
produce to a single processor or distributor. Even if we could trace a
contaminated product back to the processor or distributor, or, in the
second example, back to the packing firm, the commingling of loose
produce before it reaches the processor or distributor or at the
packing firm makes it difficult or impossible to distinguish which farm
is the source of the contaminated produce. The complexity increases if
the truck delivers the loose produce to more than one processor or
distributor.
An additional challenge associated with a traceback investigation
for fresh produce is that the produce may not always retain the same
description as it moves through the supply chain. For example, one
party in the supply chain may describe its fresh produce as ``red round
tomatoes,'' while the next party in the supply chain may describe the
same fresh produce as ``cooker tomatoes.'' Different descriptions for
the same produce can make it very difficult or impossible to determine
whether two records refer to the same or different products or
shipments.
Another challenge associated with a traceback investigation for
fresh produce is that there may be no identifier on the produce, its
package, or its case, and in associated records. Moreover, there
currently is no industry-wide or sector-wide standardization of the
information captured in the documentation. This lack of standardization
makes it difficult and time-consuming to cross-reference information
currently available in product tracing systems.
E. How Has Product Tracing Information Available in Records and on
Product Packages/Containers Helped Us During Traceback Investigations?
In the following paragraphs, we describe how we used product
tracing information to conduct two recent traceback investigations--one
involving a nonperishable packaged food, and one involving a perishable
packaged food. The information available to us included information
available in records established and maintained by parties in the
supply chain and information available on packages or containers of the
packaged food.
In February 2007, CDC notified FDA of a multi-State
outbreak of Salmonella Tennessee infections associated with the
consumption of peanut butter. Peanut butter is a nonperishable packaged
food, sold in jars. Consumers who became ill had open jars of peanut
butter available for testing. Investigators were able to test samples
of peanut butter taken from the jars and confirm the presence of
Salmonella Tennessee in the peanut butter. Investigators were able to
identify the manufacturer through information required to be on the
label of the jars (Sec. 101.5(a)) and through a product code the
manufacturer had voluntarily placed on the jars. This information made
it possible for FDA to visit the manufacturing facility the day after
we learned of the outbreak from CDC. Investigators were able to use the
product code to look in the manufacturing facility for unopened jars of
peanut butter manufactured at the same time as the jars available from
consumers. Investigators took samples of peanut butter from these
unopened jars and confirmed the presence of Salmonella Tennessee in
those samples. Investigators uncovered conditions at the manufacturer's
facility that were likely to have caused the contamination and obtained
a positive environmental sample so there was no need to further trace
the peanuts back to the farm. Our traceback investigation was
facilitated because the implicated food was a nonperishable, packaged
food that was available to investigators and contained information
about the source of the implicated food on the product container.
In September 2006, CDC informed FDA of a multi-State
outbreak of illnesses associated with the consumption of fresh spinach
contaminated with E. coli O157:H7. Fresh spinach is a perishable food
that may not remain in consumers' homes after consumers become ill and
CDC finds an association between the illness and the food. However, in
this situation the spinach was sold in a package. The traceback
investigation was facilitated because several consumers who became ill
still had packages of fresh spinach in their refrigerators. As with the
peanut butter, investigators were able to identify the processor
through information required to be on the label of the packaged spinach
(Sec. 101.5(a)) and through a product code the processor had
voluntarily placed on the package. By looking at the processor's
records, the investigators were able to identify the implicated farms
associated with the
[[Page 55119]]
identified production lot of bagged spinach. This traceback
investigation was more complex than the investigation for the peanut
butter, because it required traceback beyond the processor to the
farms. However, as with the peanut butter, the traceback investigation
was greatly facilitated by the information on the label of the packaged
food and on the package itself.
F. Industry Product Tracing Systems That Are in Use or Under
Development in the United States
1. Commodity-Specific Efforts
Various recordkeeping and other practices designed to enhance
product tracing systems are already carried out by industry within the
food supply chain. For instance, to better monitor food safety
practices of growers, the California cantaloupe industry has
incorporated product tracing requirements that involve maintaining
information such as packing date, field, and packing crew as part of
their State marketing order (Ref. 9).
Similarly, the California Tomato Farmers cooperative has instituted
documentation requirements in its membership agreement with growers to
facilitate one up/one down tracking and product tracing. The
documentation of packed tomatoes must include information about the
source (i.e., grower, production location, lot identification,
personnel/crew involved in the harvest of the product) and about the
customer receiving the product. A system to track and trace tomatoes
back to supply source and forward to customers must be developed and
tested annually (Ref. 10).
Stakeholders have developed commodity-specific food safety
guidelines for the entire supply chain for three commodities: Melons
(Ref. 11), tomatoes (Ref. 8), and lettuce and leafy greens (Ref. 12).
2. Buyer-Led Initiatives
Large food retailers, such as supermarket chains, have become more
active in ensuring the safety of the food products they purchase. One
example of this is the increasing use of independent third-party food
safety audits of grower and shipper operations to verify compliance
with good agricultural and manufacturing practices. These practices
generally include requirements that the grower or shipper maintain
records that facilitate the tracing of product produced, handled, or
processed in order to pass an audit.
For example, in February 2008, Wal-Mart, Inc., became the first
U.S. grocery chain to require suppliers of its private label and other
food products to have their factories certified against one of the
internationally-recognized Global Food Safety Initiative (GFSI)
standards (Ref. 13). The GFSI standard for traceability requires the
supplier to develop and maintain appropriate procedures and systems to
ensure (1) identification of any out-sourced product, ingredient, or
service; (2) complete records of batches of in-process or final product
and packaging throughout the production process; and (3) record of
purchaser and delivery destination for all product supplied (Ref. 14).
3. Produce Traceability Initiative (PTI)
In October 2007, the Produce Marketing Association (PMA), the
United Fresh Produce Association (UFPA), and the Canadian Produce
Marketing Association (CPMA) initiated the joint PTI (Ref. 15). The PTI
now includes more than 50 companies, including distributors, grower-
shippers, and retailers. A principal objective of the PTI is to drive
adoption of consistent ``traceability best practices'' throughout the
produce supply chain from ``field to fork.'' In pursuing the goal of
broad adoption of tracking and product tracing standards and practices,
the PTI has established a timeline for a series of milestones for
recording, tracking, and product tracing data on produce shipments.
These milestones include establishing company prefixes; establishing an
identification number for location; assigning global trade item numbers
(GTINs) to produce cases; showing GTINs, lot numbers, and packing/
harvesting dates on each case; encoding this information in bar codes;
and reading and storing the information at each point in the supply
chain. The PTI also calls for tracking and product tracing standards to
be adopted at the case level initially, followed by standards for item-
level coding (Refs. 5 and 16).
G. International Product Tracing Systems
Some countries have mandatory product tracing systems in place in
various forms, although these systems are more prevalent with respect
to animal identification than for food in general. The European Union
(EU), in addition to having a mandatory product tracing system for
animals, also requires a product tracing system for all food and feed
businesses. Specifically, the EU requires all food and feed to be
traceable ``one step forward and one step back'' in EU member states.
Food and feed business operators must be able to document where a
particular food or feed product came from and where it is going next.
Specifically, they must be able to document the names and addresses of
suppliers and customers, as well as the nature of the product and date
of delivery. They are also encouraged to keep information on the volume
and quantity of a product; the batch number, if one exists; and a more
detailed description of the product, such as whether it is fresh or
processed. Food and feed business operators must also have systems and
procedures that allow them to provide this information to the competent
authorities on demand. In addition to these general requirements,
sector-specific requirements apply to certain categories of food
products (fruit and vegetables, beef, fish, honey, olive oil) (Refs. 17
through 20). In 2007, the EU began a 4-year study to develop, test, and
evaluate two full pilot product tracing systems--one for the tomato
food chain and the other for the feed/dairy chain (Ref. 21).
In 2006, Codex established principles for tracing food through
production and distribution processes (Ref. 2). The Codex principles
are intended to assist government authorities in utilizing product
tracing as a tool within their food inspection and certification
system.
Certain private international standard setting organizations have
also developed principles and other guidelines on product tracing
systems for use by industry. For example, in 2007 the International
Standards Organization (ISO) issued ISO 22005:2007, which provides
general principles and basic requirements for designing and
implementing a product tracing system along a food processor's supply
chain.\3\ Another example is the GS1 Global Traceability Standard (Ref.
22), which is being used by the PMA, CPMA, UFPA, and other associations
involved in the PTI.
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\3\ ISO 22005:2007. ``Traceability in the feed and food chain--
General principles and basic requirements for system design and
implementation.'' July 2007. Available for purchase at https://
webstore.ansi.org.
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H. Actions Suggested by Stakeholders
Some consumer advocacy groups have asked us to develop and
implement emergency regulations that would require source tracing for
produce (farm-to-table); written food safety plans for farmers,
processors, and packinghouses; and tighter controls on repacking (Ref.
23). Some industry trade associations have asked FDA and CDC to convene
a meeting with industry representatives and work together to minimize
the human and economic impact of an outbreak (Ref. 24). These
[[Page 55120]]
trade associations urged FDA and CDC to work in partnership with
industry to find solutions to speed up and streamline outbreak
identification and response. These trade associations also recommended
that a working group be established to look at crisis management
systems and that teams of industry experts be established to help in
traceback investigations.
I. Issues and Questions for Discussion
As previously noted, we need to increase the speed and accuracy of
traceback investigations to help limit the public health impact of a
foodborne illness outbreak; to limit to a particular region, locality,
farm(s), or processor(s) the source of the problem (where the source is
in fact limited), so that an entire industry is not unnecessarily
affected; to enable public health authorities and the food industry to
provide targeted and accurate information about affected food to
consumers; to institute steps to correct the source of contamination;
and, as a result, to restore or enhance consumer confidence in produce
safety.
We intend the public meetings to stimulate and focus a discussion
about mechanisms to enhance product tracing systems for fresh produce
and to improve FDA's ability to use the information in such systems to
identify the source of contamination associated with fresh produce-
related outbreaks of foodborne illness. This discussion will help FDA
determine what short and long term steps, such as issuing regulations,
we should take to enhance the current tracing system. Aspects of these
measures could require new legal authority. We welcome public comments
and/or data on the following issues related to product tracing systems
for fresh produce:
1. Should a ``fresh produce identifier'' be assigned to fresh
produce? If so, at what stage or stages in the supply chain should such
an identifier be assigned or modified? What data or information would
be useful to include in such an identifier? Should the identifier be
placed on the fresh produce, the package, the shipping container, and/
or the invoice or bill of lading? Should the location of the identifier
depend on the type of produce or on other factors?
Our investigations of the 2006 outbreak associated with packaged
fresh spinach and the 2007 outbreak associated with peanut butter were
greatly facilitated by a product ``code'' that the party who packaged
the implicated product had assigned to the packaged product. We seek
comment on whether a ``fresh produce identifier'' should be assigned to
fresh produce, and, if so, at what stage or stages in the supply chain
and with what information elements.
2. What other data or information would be useful on the invoice or
bill of lading, fresh produce, package, or shipping case? At what stage
or stages in the supply chain should such data or information be
included?
The product ``codes'' assigned to the packaged fresh spinach
associated with the 2006 outbreak and to the peanut butter associated
with the 2007 outbreak were present on the packaged products. We seek
comment on whether any other data or information (in addition to or
instead of the fresh produce identifier discussed in question 1) should
be on or attached to the invoice, bill of lading, fresh produce, its
package (when feasible), or the shipping case.
3. Should an enhanced product tracing system extend to all fresh
produce? If not, what criteria should be used to determine coverage?
There are a number of factors that may increase or decrease the
risk for contamination of produce. Such factors may include crop
characteristics (e.g., proximity of the edible portion of the crop to
the soil, or rough surface, such as cantaloupe); production practices
or conditions (e.g., water quality for field and packing operations);
method of irrigation; likelihood of animal intrusion; and worker health
and hygiene. Should these or other factors (e.g., history of outbreaks)
be considered in prioritizing the development and application of an
enhanced product tracing system?
4. Should fresh produce be commingled? If commingling is
unavoidable, what practices should an enhanced product tracing system
include to ensure that fresh produce can be traced effectively and
efficiently?
Some industry food safety guidelines advise against commingling
(Ref. 8). Should parties in the supply chain for some or all
commodities consider refining or designing their product tracing
systems so that they can identify the source of individual pieces of
fresh produce if they combine or commingle produce from multiple
sources and link this information to the one-up/one-down records they
establish and maintain? If such identification is not feasible, should
parties in the supply chain for some or all commodities consider no
longer combining or commingling produce? We seek comment on any
measures already in place to address product tracing of commingled
fresh produce and the extent to which such measures have been
demonstrated to be successful in ensuring product tracing, particularly
during traceback investigations.
5. What should be the scope of an enhanced product tracing system
for fresh produce?
As stated previously, the supply chain for fresh produce is often
complex. We seek comment concerning how an enhanced product tracing
system for fresh produce should apply to various parties in the supply
chain, including producers, packers, distributors, and retailers. More
specifically, we seek comment on whether some or all aspects of an
enhanced product tracing system for fresh produce should apply to some
or all farms. For example, if a fresh produce identifier includes
information about the date of harvest, the farm is the party who would
have that information. It may be more practical for the farm to
identify the date of harvest on the invoice when it ships the fresh
produce than for the first party in the supply chain to subsequently
contact the farm to determine the date of harvest.
We also seek comment on whether some or all aspects of an enhanced
product tracing system for fresh produce should apply to some or all
restaurants or retailers. For example, if a ``fresh produce
identifier'' is assigned to produce a restaurant receives, we seek
comment on whether the restaurant could establish and maintain records
of that identifier or could retain the invoice or bill of lading if the
information is contained on those documents.
We also seek comment on whether some or all aspects of an enhanced
product tracing system for fresh produce should extend to consumers.
Product tracing systems currently used by the fresh produce industry
typically do not reach the consumer level. However, some segments of
the supply chain can and do record some individual consumer
information, and may be able to use this information to alert specific
consumers about product recalls or for other purposes. For example, a
retailer who has a ``frequent customer'' or ``bonus card'' program may
record each cardholder's purchases. The retailer's consumer purchasing
information also would be very helpful in those situations where the
fresh produce that is possibly linked to a foodborne illness outbreak
is eaten and the consumers have disposed of any identifiers on the
fresh produce before a traceback investigation begins. Could such
systems be adapted or modified to provide assistance with traceback
investigations? Would there be any issues or concerns associated with
such systems?
[[Page 55121]]
6. Should the data or information in an enhanced product tracing
system be human-readable, technology-based, or both? If technology-
based, what technology should be used?
``Human-readable'' information should enable all parties in the
supply chain, regardless of the technology used, to read this
information. By ``human-readable,'' we mean information consisting of
numbers and/or letters capable of being read by the human eye.
Technology-based systems could make it faster and easier to accurately
record information such as a fresh produce identifier. For example, a
person making a paper record of a human-readable identifier expressed
in numbers or letters may mistakenly transpose or omit numbers or
letters, thus creating erroneous entries in the records. In contrast,
the potential for such mistakes is greatly reduced if the identifier is
recorded using an automatic system such as a bar code or RFID. In
addition, technology-based systems could greatly speed a traceback
investigation. However, some parties may not have access to electronic
technologies. We seek comment on whether data or information in an
enhanced product tracing system should be human-readable, technology-
based, or both. If technology-based, what technology should be used?
7. What (if any) data or information in an enhanced product tracing
system should be standardized?
The lack of standardization in the information in current product
tracing systems can frustrate traceback investigations. We seek comment
on whether the various segments of the fresh produce industry should
develop standards for the content and format of records, particularly
of electronic records that could help make electronic record systems
interoperable. We seek comment on the existence and utility of existing
standards relevant to some or all of the information elements that
would be in an enhanced product tracing system, such as in a fresh
produce identifier. We also seek comment on whether such standards
should be developed and on whether current or newly developed standards
should be identified in any guidance or regulations issued by FDA. We
also seek comment on whether and how current or newly developed
standards for the content and format of electronic systems could have
practical utility for parties who continue to use paper-based
technology. For example, could human-readable data that support
standardized technology-based data be useful to parties who continue to
use paper-based technology?
8. What are the costs, benefits, and feasibility of implementing an
enhanced product tracing system?
Further enhancing the product tracing system for fresh produce
could aid us in shortening the duration of outbreaks and limiting the
number of people who become ill. It could also give us more information
to use in preventing future outbreaks. However, these benefits will not
come equally from all types of fresh produce. Enhancing the product
tracing system beyond current practices and requirements for certain
types of fresh produce might not significantly enhance public health if
the fresh produce has not been associated with foodborne illness or any
known risk factors. An enhanced fresh product tracing system for fresh
produce may also impose burdens on entities in the supply chain. We
seek comment on the costs, benefits, and feasibility of implementing an
enhanced product tracing system for each of the parties in the supply
chain.
We recognize that enhancing product tracing of fresh produce may
not be just a matter of keeping more or different records or adding
more information to product or packaging, but also of changing business
practices. We request comment on the extent to which an enhanced
product tracing system for fresh produce will affect comingling and
repacking of produce and the cost of any such changes in the supply
chain.
9. Would enhancing FDA's role in developing and implementing
effective product tracing systems for fresh produce, through increased
regulation, guidance, or additional legal authorities, improve the
effectiveness of traceback investigations and traceforward operations?
What mandatory and voluntary measures would be most effective in
achieving the goal of enhancing product tracing systems for fresh
produce and improving FDA's ability to use the information in such
systems to identify the source of contamination associated with fresh
produce-related outbreaks of foodborne illness? How would these
measures help FDA work better with industry and other stakeholders
during traceback investigations and traceforward operations?
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see table 1 of this document) written or electronic comments for
consideration at or after the meeting in addition to, or in place of, a
request for an opportunity to make an oral presentation. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
V. References
We have placed the following references on display in the Division
of Dockets Management (see table 1 of this document). You may see them
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the
Web site addresses, but FDA is not responsible for any subsequent
changes to Web sites after this document publishes in the Federal
Register.)
1. U.S. Food and Drug Administration, 1996-2007 Produce
Outbreaks (unpublished compilation).
2. Codex Alimentarius Commission. 2006. Principles for
Traceability/Product Tracing As a Tool Within A Food Inspection and
Certification System. CAC/GL60-2006. Available at https://
www.codexalimentarius.net/web/standard_list.do?lang=en. Accessed
and printed on July 18, 2008.
3. U.S. Food and Drug Administration. 2004. ``What You Need to
Know About Establishment and Maintenance of Records.'' Available at
https://www.cfsan.fda.gov/~acrobat/fsbtrec.pdf.
4. U.S. Food and Drug Administration. ``Questions and Answers
Regarding Establishment and Maintenance of Records. Edition 4.''
Available at https://www.cfsan.fda.gov/~dms/recguid4.html.
5. Produce Marketing Association and Canadian Produce Marketing
Association. 2006. Fresh Produce Traceability. A Guide To
Implementation. Available at https://www.pma.com/cig/tech/
traceability.cfm. Accessed and printed on June 18, 2008.
6. Roberta Cook, ``The U.S. Fresh Produce Industry: An Industry
in Transition,'' in Postharvest Technology of Horticultural Crops
(Adel Kader ed., 2001).
7. U.S. Department of Agriculture, Agricultural Marketing
Service. Issued February 2006. Fresh Fruit and Vegetable Shipments
By Commodities, States, and Months. FVAS-4 Calendar Year 2005.
Available at https://www.ams.usda.gov. Accessed and printed on July
22, 2008.
8. North American Tomato Trade Work Group. 2008. Commodity
Specific Food Safety Guidelines for the Fresh Tomato Supply Chain,
Edition 2. Available at https://www.californiatomatofarmers.com/pdfs/
TomatoGuidelinesJuly08.pdf. Accessed and printed on September 11,
2008.
[[Page 55122]]
9. U.S. Department of Agriculture, Economic Research Service
(Golan, E., Krissoff B., Kuchler F., Nelson K., Price G.). 2004.
Agricultural Economic Report No. 830. ``Traceability in the U.S.
Food Supply: Economic Theory and Industry Studies,'' p. 17 (p. 25 of
the electronic document). Available at https://www.ers.usda.gov/
publications/aer830/aer830.pdf. Accessed and printed on August 4,
2008.
10. California Tomato Farmers. Food Safety Program. Available at
https://www.californiatomatofarmers.com/foodsafety.asp. Accessed and
printed on August 4, 2008.
11. Produce Industry Food Safety Initiative co-sponsored by the
Produce Marketing Association and the United Fresh Fruit and
Vegetable Association. 2005. Commodity Specific Food Safety
Guidelines for the Melon Supply Chain. 1st Edition. Available at
https://www.cfsan.fda.gov/~dms/melonsup.html. Accessed and printed on
August 7, 2008.
12. International Fresh-cut Produce Association, Produce
Marketing Association, United Fresh Fruit and Vegetable Association,
and Western Growers. 2006. Commodity Specific Food Safety Guidelines
for the Lettuce and Leafy Greens Supply Chain. 1st Edition.
Available at https://www.cfsan.fda.gov/~dms/lettsup.html. Accessed
and printed on August 7, 2008.
13. Wal-Mart, Inc., press release, February 4, 2008. Available
at https://walmartstores.com/FactsNews/NewsRoom/7918.aspx. Accessed
and printed on August 29, 2008.
14. Global Food Safety Initiative, GFSI Guidance Document, 5th
Edition, September 2007. Available at https://www.ciesnet.com/pfiles/
programmes/foodsafety/GFSI_Guidance_Document_5th%20Edition%20_
September%202007.pdf. Accessed and printed on September 4, 2008.
15. Produce Marketing Association, Canadian Produce Marketing
Association, and United Fresh Produce Association. 2007. Joint
Release. Available at https://www.cpma.ca/pdf/IndustryTech/
Traceability_Joint_Release_PMA_CPMA_UFPA_Oct2007.pdf. Accessed
and printed on July 22, 2008.
16. CPMA/PMA Traceability Task Force. Traceability Best
Practices. Fresh Produce Industry (North America). Available at
https://www.cpma.ca/pdf/IndustryTech/TraceabilityBestPractices.pdf.
Accessed and printed on July 18, 2008.
17. U.S. Government Accounting Office. 2008. Report to
Congressional Requestors. Food Safety. Selected Countries Can Offer
Insights into Ensuring Import Safety and Responding to Foodborne
Illness. GAO 08-794. Available at https://www.gao.gov/new.items/
d08794.pdf. Accessed and printed on July 18, 2008.
18. European Commission. Health and Consumer Protection
Directorate General. 2007 Factsheet. Food Traceability. Available at
https://ec.europa.eu/food/food/foodlaw/traceability/factsheet--
trace--2007--en.pdf. Accessed and printed on July 20, 2008.
19. Standing Committee On The Food Chain And Animal Health.
Guidance On The Implementation Of Articles 11, 12, 16, 17, 18, 19
AND 20 of Regulation (EC) N[deg] 178/2002 on General Food Law.
Available at https://ec.europa.eu/food/food/foodlaw/guidance/
guidance--rev--7--en.pdf. Accessed and printed on September 3, 2008.
20. Commission of the European Communities, ``Commission
Regulation (EC) No 178/2002 of the European Parliament and of the
Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety.''
Official Journal of the European Union, 1.2.2002 L31/1-L31/24, 2002.
Available at https://eur-lex.europa.eu/pri/en/oj/dat/2002/l--031/l--
03120020201en00010024.pdf. Accessed and printed on July 22, 2008.
21. Traceback--Keeping Track of the Food Trail. Available at
ftp://ftp.cordis.europa.eu/pub/food/docs/traceback.pdf. Accessed and
printed on July 24, 2008.
22. GS1 Global Traceability Standard. Available at https://
www.gs1.org/productssolutions/traceability/. Accessed and printed on
July 18, 2008.
23. Letter dated July 3, 2008 from Michael F. Jacobson and
Caroline Smith de Waal of the Center for Science in the Public
Interest and Chris Waldrop of the Consumer Federation of America to
Andrew C. von Eschenbach of the U.S. Food and Drug Administration.
Available at https://cspinet.org/new/pdf/von_eshenbach_
traceability_letter.pdf. Accessed and printed on July 19, 2008.
24. Letter dated July 3, 2008, from Thomas E. Stenzel of United
Fresh Produce Association and Bryan Silbermann of Produce Marketing
Association to Secretary Michael O. Leavitt of the U.S. Department
of Health and Human Services. Available at https://
www.unitedfresh.org/assets/files/PMA_UFPA_2nd_HHS_Meeting_
Request_7308.pdf. Accessed and printed on July 21, 2008.
Dated: September 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22430 Filed 9-19-08; 4:15 pm]
BILLING CODE 4160-01-S
