More from the FDA docket
on Product Tracing Systems for Food. This submission comes from the
Center for Science in the Public Interest. This group wants a very
robust system of traceability - even "leveraging consumer loyalty
programs" and also calls for stepped up routine inspections of company
records and providing more information readable by consumers.




The Center for Science in the Public Interest (CSPI) appreciates this opportunity to comment on the matter of Product Tracing Systems for Food [Docket No. FDA-2009-N-0523, Nov. 3, 2009].

CSPI is a non-profit consumer advocacy and education organization that focuses largely on food safety and nutrition issues. It is supported principally by the more than 900,000 subscribers to its Nutrition Action Healthletter and by foundation grants.

CSPI supports instituting traceability requirements for all food products as a critical component in protecting consumers from the spread of foodborne disease. Effective traceability, however, must extend beyond identifying the origin of a hazardous food item and locating it in the flow of commerce.

Traceability systems must also provide useful information to consumers so that they can evaluate the safety of products in the home. We believe an effective system must have the following elements:

Routine access to company records
during inspections to ensure companies in the food-supply chain keep records of the source and destination of foods they handle

A requirement that food traveling in commerce carry identifying information
that allows government investigators to quickly trace it back to its source and permit them to track it forward to all distribution points

A human readable label that communicates essential identifying information
to consumers; and improved notification through effective use of available technology

I. Routine access to company records during inspections to ensure companies in the food-supply chain keep records of the source and destination of foods they handle.

The record access and one-up/one-down traceability required by the Bioterrorism Act of 2002 have proven ineffective. In 2008 the Food and Drug Administration was unable to trace tomatoes through the supply chain because the recordkeeping requirements did not capture critical information.

Comingling in packing plants and changing nomenclatures made it difficult for FDA to reliably identify the source of a particular tomato.1 This shortcoming is compounded further by the poor compliance record of firms with the basic requirements of the Act.

1 Statement of David Acheson, before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, House Committee on Appropriations, Sept. 17, 2008.


A review by the FDA Inspector General in 2008 discovered only five in 40 products could be traced with confidence using one-up/one-down recordkeeping.

 It discovered that 59 percent of facilities do not comply with the law and 25 percent were not even aware they had to keep records.
This poor compliance history is a result of FDA’s inability to review records on a routine basis.2 Under section 414 of the Food, Drug, and Cosmetics Act, the agency may only access records if the Secretary has a reasonable belief the product is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

That standard means that FDA may only access the records and thereby determine compliance after an outbreak has begun, which is too late to protect the public. The Inspector General made several recommendations that the agency should implement.

FDA should strengthen lot specific recordkeeping requirements, extend traceability records to all products, and have access to records during routine inspections. Adopting these changes would provide the agency with greater assurance that companies utilize accurate and complete recordkeeping that is essential to tracing products as they are processed, packaged and moved through the food supply chain.

II. A requirement that food traveling in commerce carry identifying information that allows government investigators to quickly trace it back to its source and permit them to track it forward to all distribution points Many companies already employ traceability systems for quality control and inventory purposes.

These systems may involve paper records, scanning technology or electronic tags, and utilize computer databases. Additionally, bar coding is ubiquitous in food retailing and carries or can carry useful information about a product’s identity.

These systems already in place provide a basis for establishing a national food safety traceability system. Where such systems are used, FDA and the Food Safety and Inspection Service should require them to be readable by inspectors for traceability purposes. Ideally, the agencies should require an article of food moving through commerce in the United States should carry a human readable label that permits government agents to locate information on its source and destination.

III. A human readable label that communicates essential identifying information to consumers; and improved notification through effective use of available technology

For traceability systems to be effective public health tools, they must provide consumers with a means of identifying the food item in the home. In 2008, FDA issued a series of warnings regarding Salmonella-contaminated cantaloupes. These warnings typically read that the cantaloupes were distributed in cardboard cartons with the brand name and “Product of Honduras” printed on them.

The warning, unfortunately, did not provide useful information to consumers since they rarely buy cantaloupes by the carton. However, nearly every cantaloupe carries a sticker, and that can be used to provide both machine and human readable information.

To warn consumers in the home, it is essential that the unique identifier should also have a human readable label. Such a label is vital to protect consumers who have already purchased recalled product. FDA could greatly enhance it public notification during a recall if FDA provided information, as FSIS does, on the retail consignee of contaminated products.
 Additional protections would be available if existing commercial tracking systems were used by retailers, who could provide proactive notification of consumers where retailers also have consumer loyalty programs.

These programs provide inventory control and track preferences of particular consumers for marketing purposes. That commercial use should be leveraged for public safety purposes to improve recall notification to consumers.

We know that many consumers will not go to government websites and may not see media reports, or if they do may believe the warnings do not apply to them. Customer loyalty programs provide a method of directly contacting consumers to alert them that a product they specifically purchased may be hazardous and is being recalled.

IV. Conclusion. The purpose of traceability is to provide food safety agencies and commercial suppliers with a tool for protecting consumers from foodborne illness due to intentional and unintentional contamination of food. To be effective,

 FDA must review company compliance to ensure they are keeping the basic records essential to the system’s performance as part of routine inspections. The system can build on existing traceability technology as long as FDA and FSIS inspectors are able to read and interpret the information produced by it to quickly identify the source and destination of food.

Eventually, all companies in the food supply chain should be required to have a traceability system. No traceability system will be adequate unless it provides a means for consumers to understand when a product in their home has been recalled. FDA and FSIS should leverage customer loyalty programs to ensure to the greatest extent possible that consumers are notified that they have purchased a recalled product.

Respectfully submitted,
David W. Plunkett, JD, JM
Senior Staff Attorney
Center for Science in the Public Interest