Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55115 

meetings. Please visit our Web site at 

http://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. 

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 Meeting 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

http://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 http:// 

www.regulations.gov, including any 

personal information provided. 

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 


jlentini on PROD1PC65 with NOTICES
55116 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

TABLE 1.—Continued 

Date Address Electronic Address Other Information 

Second Public Meeting 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

http://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 http:// 

www.regulations.gov, including any 

personal information provided. 

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 

Submit comments January 22, 2009 Division of Dockets Management (HFA–305), Food 

and Drug Administration, 

5630 Fishers Lane rm. 

1061, Rockville, MD 20852 

http:// 

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. 

1You may also register by mail, fax, e-mail, or phone by providing registration information (including name, title, firm name, address, telephone 

number, fax number, and e-mail address), requests to make an oral presentation, and written material for the presentation to the contact person 

for registration (see FOR FURTHER INFORMATION CONTACT). 

II. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

III. Background 

A. Introduction 

Food can become contaminated at 

many different steps in the farm-to-table 

continuum—on the farm; in packing, 

processing, or distribution facilities; 

during storage or transit; at retail 

establishments; in restaurants; and in 

the home. In recent years, FDA has done 

a great deal to prevent both deliberate 

and unintentional contamination of 

food at each of these steps. FDA has 

worked with other Federal, State, local, 

tribal, and foreign counterpart food 

safety agencies, as well as with law 

enforcement agencies, 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), 

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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55117 

1The 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. 

2For 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). 

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). 

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: 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)). 


jlentini on PROD1PC65 with NOTICES
55118 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

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 (§ 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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55119 

3 ISO 22005:2007. ‘‘Traceability in the feed and 

food chain—General principles and basic 

requirements for system design and 

implementation.’’ July 2007. Available for purchase 

at http://webstore.ansi.org. 

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, WalMart, 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 inprocess 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. 

H. Actions Suggested by Stakeholders 

Some consumer advocacy groups 

have asked us to develop and 

implement emergency regulations that 

would require source tracing for 

produce (farm-to-table); written food 

safety plans for farmers, processors, and 

packinghouses; and tighter controls on 

repacking (Ref. 23). Some industry trade 

associations have asked FDA and CDC 

to convene a meeting with industry 

representatives and work together to 

minimize the human and economic 

impact of an outbreak (Ref. 24). These 


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55120 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

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/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 

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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Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 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 ‘‘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? 

8. What are the costs, benefits, and 

feasibility of implementing an enhanced 

product tracing system? 

Further enhancing the product tracing 

system for fresh produce could aid us in 

shortening the duration of outbreaks 

and limiting the number of people who 

become ill. It could also give us more 

information to use in preventing future 

outbreaks. However, these benefits will 

not come equally from all types of fresh 

produce. Enhancing the product tracing 

system beyond current practices and 

requirements for certain types of fresh 

produce might not significantly enhance 

public health if the fresh produce has 

not been associated with foodborne 

illness or any known risk factors. An 

enhanced fresh product tracing system 

for fresh produce may also impose 

burdens on entities in the supply chain. 

We seek comment on the costs, benefits, 

and feasibility of implementing an 

enhanced product tracing system for 

each of the parties in the supply chain. 

We recognize that enhancing product 

tracing of fresh produce may not be just 

a matter of keeping more or different 

records or adding more information to 

product or packaging, but also of 

changing business practices. We request 

comment on the extent to which an 

enhanced product tracing system for 

fresh produce will affect comingling and 

repacking of produce and the cost of any 

such changes in the supply chain. 

9. Would enhancing FDA’s role in 

developing and implementing effective 

product tracing systems for fresh 

produce, through increased regulation, 

guidance, or additional legal authorities, 

improve the effectiveness of traceback 

investigations and traceforward 

operations? What mandatory and 

voluntary measures would be most 

effective in achieving the goal of 

enhancing product tracing systems for 

fresh produce and improving FDA’s 

ability to use the information in such 

systems to identify the source of 

contamination associated with fresh 

produce-related outbreaks of foodborne 

illness? How would these measures help 

FDA work better with industry and 

other stakeholders during traceback 

investigations and traceforward 

operations? 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

table 1 of this document) written or 

electronic comments for consideration 

at or after the meeting in addition to, or 

in place of, a request for an opportunity 

to make an oral presentation. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

V. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see table 1 of this 

document). You may see them between 

9 a.m. and 4 p.m., Monday through 

Friday. (FDA has verified the Web site 

addresses, but FDA is not responsible 

for any subsequent changes to Web sites 

after this document publishes in the 

Federal Register.) 

1. U.S. Food and Drug Administration, 

1996–2007 Produce Outbreaks (unpublished 

compilation). 

2. Codex Alimentarius Commission. 2006. 

Principles for Traceability/Product Tracing 

As a Tool Within A Food Inspection and 

Certification System. CAC/GL60–2006. 

Available at http:// 

www.codexalimentarius.net/web/ 

standard_list.do?lang=en. Accessed and 

printed on July 18, 2008. 

3. U.S. Food and Drug Administration. 

2004. ‘‘What You Need to Know About 

Establishment and Maintenance of Records.’’ 

Available at http://www.cfsan.fda.gov/ 

~acrobat/fsbtrec.pdf. 

4. U.S. Food and Drug Administration. 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of Records. 

Edition 4.’’ Available at http:// 

www.cfsan.fda.gov/~dms/recguid4.html. 

5. Produce Marketing Association and 

Canadian Produce Marketing Association. 

2006. Fresh Produce Traceability. A Guide 

To Implementation. Available at http:// 

www.pma.com/cig/tech/traceability.cfm. 

Accessed and printed on June 18, 2008. 

6. Roberta Cook, ‘‘The U.S. Fresh Produce 

Industry: An Industry in Transition,’’ in 

Postharvest Technology of Horticultural 

Crops (Adel Kader ed., 2001). 

7. U.S. Department of Agriculture, 

Agricultural Marketing Service. Issued 

February 2006. Fresh Fruit and Vegetable 

Shipments By Commodities, States, and 

Months. FVAS–4 Calendar Year 2005. 

Available at http://www.ams.usda.gov. 

Accessed and printed on July 22, 2008. 

8. North American Tomato Trade Work 

Group. 2008. Commodity Specific Food 

Safety Guidelines for the Fresh Tomato 

Supply Chain, Edition 2. Available at http:// 

www.californiatomatofarmers.com/pdfs/ 

TomatoGuidelinesJuly08.pdf. Accessed and 

printed on September 11, 2008. 


jlentini on PROD1PC65 with NOTICES
55122 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 http://www.ers.usda.gov/ 

publications/aer830/aer830.pdf. Accessed 

and printed on August 4, 2008. 

10. California Tomato Farmers. Food Safety 

Program. Available at http:// 

www.californiatomatofarmers.com/ 

foodsafety.asp. Accessed and printed on 

August 4, 2008. 

11. Produce Industry Food Safety Initiative 

co-sponsored by the Produce Marketing 

Association and the United Fresh Fruit and 

Vegetable Association. 2005. Commodity 

Specific Food Safety Guidelines for the 

Melon Supply Chain. 1st Edition. Available 

at http://www.cfsan.fda.gov/~dms/ 

melonsup.html. Accessed and printed on 

August 7, 2008. 

12. International Fresh-cut Produce 

Association, Produce Marketing Association, 

United Fresh Fruit and Vegetable 

Association, and Western Growers. 2006. 

Commodity Specific Food Safety Guidelines 

for the Lettuce and Leafy Greens Supply 

Chain. 1st Edition. Available at http:// 

www.cfsan.fda.gov/~dms/lettsup.html. 

Accessed and printed on August 7, 2008. 

13. Wal-Mart, Inc., press release, February 

4, 2008. Available at http:// 

walmartstores.com/FactsNews/NewsRoom/ 

7918.aspx. Accessed and printed on August 

29, 2008. 

14. Global Food Safety Initiative, GFSI 

Guidance Document, 5th Edition, September 

2007. Available at http://www.ciesnet.com/ 

pfiles/programmes/foodsafety/ 

GFSI_Guidance_Document_5th%20Edition

%20_September%202007.pdf. Accessed and 

printed on September 4, 2008. 

15. Produce Marketing Association, 

Canadian Produce Marketing Association, 

and United Fresh Produce Association. 2007. 

Joint Release. Available at http:// 

www.cpma.ca/pdf/IndustryTech/ 

Traceability_Joint_Release_

PMA_CPMA_UFPA_Oct2007.pdf. Accessed 

and printed on July 22, 2008. 

16. CPMA/PMA Traceability Task Force. 

Traceability Best Practices. Fresh Produce 

Industry (North America). Available at http:// 

www.cpma.ca/pdf/IndustryTech/ 

TraceabilityBestPractices.pdf. Accessed and 

printed on July 18, 2008. 

17. U.S. Government Accounting Office. 

2008. Report to Congressional Requestors. 

Food Safety. Selected Countries Can Offer 

Insights into Ensuring Import Safety and 

Responding to Foodborne Illness. GAO 08– 

794. Available at http://www.gao.gov/ 

new.items/d08794.pdf. Accessed and printed 

on July 18, 2008. 

18. European Commission. Health and 

Consumer Protection Directorate General. 

2007 Factsheet. Food Traceability. Available 

at http://ec.europa.eu/food/food/foodlaw/ 

traceability/factsheet_trace_2007_en.pdf. 

Accessed and printed on July 20, 2008. 

19. Standing Committee On The Food 

Chain And Animal Health. Guidance On The 

Implementation Of Articles 11, 12, 16, 17, 18, 

19 AND 20 of Regulation (EC) N° 178/2002 

on General Food Law. Available at http:// 

ec.europa.eu/food/food/foodlaw/guidance/ 

guidance_rev_7_en.pdf. Accessed and 

printed on September 3, 2008. 

20. Commission of the European 

Communities, ‘‘Commission Regulation (EC) 

No 178/2002 of the European Parliament and 

of the Council of 28 January 2002 laying 

down the general principles and 

requirements of food law, establishing the 

European Food Safety Authority and laying 

down procedures in matters of food safety.’’ 

Official Journal of the European Union, 

1.2.2002 L31/1–L31/24, 2002. Available at 

http://eur-lex.europa.eu/pri/en/oj/dat/2002/ 

l_031/l_03120020201en00010024.pdf. 

Accessed and printed on July 22, 2008. 

21. Traceback—Keeping Track of the Food 

Trail. Available at ftp://ftp.cordis.europa.eu/ 

pub/food/docs/traceback.pdf. Accessed and 

printed on July 24, 2008. 

22. GS1 Global Traceability Standard. 

Available at http://www.gs1.org/ 

productssolutions/traceability/. Accessed 

and printed on July 18, 2008. 

23. Letter dated July 3, 2008 from Michael 

F. Jacobson and Caroline Smith de Waal of 

the Center for Science in the Public Interest 

and Chris Waldrop of the Consumer 

Federation of America to Andrew C. von 

Eschenbach of the U.S. Food and Drug 

Administration. Available at http:// 

cspinet.org/new/pdf/von_eshenbach

_traceability_letter.pdf. Accessed and printed 

on July 19, 2008. 

24. Letter dated July 3, 2008, from Thomas 

E. Stenzel of United Fresh Produce 

Association and Bryan Silbermann of 

Produce Marketing Association to Secretary 

Michael O. Leavitt of the U.S. Department of 

Health and Human Services. Available at 

http://www.unitedfresh.org/assets/files/ 

PMA_UFPA_2nd_HHS_Meeting_

Request_7308.pdf. Accessed and printed on 

July 21, 2008. 

Dated: September 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22430 Filed 9–19–08; 4:15 pm] 

BILLING CODE 4160–01–S 

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 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 which requires 

60 days for public comment on 

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 


jlentini on PROD1PC65 with NOTICES