Food Safety Magazine, October/November 2010

and 2, even something as American as a cheeseburger can have ingredients sourced from around the world.

Current Requirements

Different parts of the food industry are subject to different laws that are often administered by different government agencies. However, the 2002 Bioterrorism Act provided a major recordkeeping requirement that most equate with product tracing. The Act requires what is commonly referred to as “one up/one back” recordkeeping. Specifically, recipients of a product are required to record from whom they received a product, and upon shipping, they must document to whom they sent product. The assumption that the requirements of the Act provide product tracing is wrong for at least three reasons. First, some are exempt. Exemptions at the ends of the supply chain, such as the farm and retail, are not ideal, but with the one up/one back system, the primary recipient of a product from a farm should know where the product came from, making a matching record at the farm level redundant. The greater issue with the exemptions is when they apply to those in the middle of the supply chain, such as brokers, who play a major role in the food production system. A lack of records results in a break in the chain. The second issue with the Act is the inadequacy of the data required to allow for product tracing. Lot numbers are critical pieces of information to distinguish product. Language in the Act reads that lot numbers shall be recorded “if available,” and this provides a substantial amount of wiggle room. In fact, in the IFT study, a major barrier to improving product tracing was that suppliers did not provide the necessary information. Lastly, had the Act been written to provide perfect product tracing, requiring all in the supply chain—at least the part in the U.S.—to keep the appropriate information, the FDA could not impose these requirements around the globe, nor could the FDA enforce them. Everyone involved in food understands the tangled web of food production and procurement, and the concept of worldwide food tracing, though necessary, seems daunting.

quire product tracking to the case level and 2) additional recordkeeping requirements would be imposed for “high-risk foods.” Part of the definition of “ high-risk foods” pertains to the processing steps that reduce likelihood of contamination. Clearly, lack of compliance with Good Manufacturing Practices is not accounted for, and many foods involved in recent outbreaks would not have been designated “high-risk.”

Tracing in House Bill 2749

In contrast to the Senate bill, the House bill, which has already made its way through the full House, provides much more detail on product tracing requirements. It would authorize the Secretary of HHS to “(i) identify technologies and methodologies for tracing the distribution history of a food that is, or may be, used by members of different sectors of the food industry, including technologies and methodologies to enable each person who produces, manufactures, processes, packs, transports or holds a food to (I) maintain the full pedigree of the origin and previous dis-

Pending Legislation

At several points over the past few years, a la carte product tracing bills have been proposed by various members of the U.S. Congress, and are included in Table 1. It now appears that the greatest change to product tracing requirements will result from the passage of some form of the Food Safety Modernization Act (S510, which has not yet passed the full Senate as of this writ-ing, and HR 2749, which passed the full House in the Summer of 2009).

Tracing in Senate Bill S510

The product tracing requirements outlined in the current version of S510 give the Secretary of the Department of Health and Human Services (HHS), who oversees the FDA, a great deal of flexibility regarding the implementation of product tracing systems. It must be noted that the Senate bill has not yet passed the full Senate, with a manager’s amendment released in August 2010. Despite the overall general language on product tracing, there are two specific elements that may decrease the ability to trace food: 1) the legislation would not re-

Traceability system for all stages of
manufacturing, processing, packaging
and distribution
HR 875 National traceability system of 2009

that enables the Administrator to
retrieve the history, use and location
of an article of food through all stages
of its production, processing and
distribution
Food Safety Tracking S425 Establish a national traceability
S510 Secretary (HHS) shall provide a report
with recommendations for enhanced
surveillance, outbreak response and
traceability
HR 6024 Secretary (Ag) must trace
contaminated beef samples to identify
all sites of adulteration and
contamination, including preparation,
packaging and slaughtering
establishments