Lost opportunity?

I was talking with David Plunkett, a lobbyist for the Center for Science in the Public Interest, earlier today about his perceptions of the produce industry position on traceability. (Find his powerpoint presentation here to the Oct. 16 FDA traceability meeting)

While commending the industry's recent push toward a more efficient traceability system, he said the industry was "feeling the pain" from the ineffectiveness of the 2002 bioterrorism law. Rather than have a efficient traceability system in place as a result of the 2002 law, he said what emerged from the regulatory process to implement that law was a weakened "one step up and one step back" approach. Likewise, instead of the entire industry of sharing the costs of an efficient traceability system starting in 2003, the costs and penalties for an ineffective system have shifted to subsets of the produce industry - namely leafy greens and tomatoes. He pointed to the July 31 testimony of William Hubbard (Coalition for a Stronger FDA) before the House Energy and Commerce, Oversight and Investigations subcommittee. From Hubbard's testimony on July 31:


As you know, after the September 11 attacks seven years ago, Congress was concerned that the food supply could be vulnerable to terrorism, and enacted the Bioterrorism Act of 2002 (formally titled the Public Health Security and Bioterrorism Preparedness and Response Act). One provision of that statute required food firms to establish and maintain records detailing the movement of food through the supply chain, with the intention of giving FDA the ability to rapidly trace sources of contamination; and thereby blunt the potentially devastating effects of intentionally contaminated food.
Unfortunately, the transition from what was believed needed right after 9/11 to what they agency actually got months later when it promulgated its regulations on recordkeeping is
a virtual case study in how to weaken a regulation to the point of being indistinguishable from the original intent. Indeed, if we were to consider the tomato/pepper salmonella search as a test of the recordkeeping rule, I think it’s fair to conclude that the grade would be a fairly clear “F.” Let me explain, and in so doing describe why the old axiom of not wanting to watch laws or sausages being made can also apply to implementing regulations.
Below is a brief “side-by-side” analysis of some of the key weak points introduced into the original legislation and regulation as it was being reviewed and considered by Administration reviewers:


What FDA wanted/needed Final Rule Provisions
Records by all sources/recipients Farms and restaurants excluded
Foreign firms as well as U.S. Foreign firms dropped
Complete record of a food’s movements Only “one forward, one back”
Lot numbers for each shipment Denied
Electronic records (for speed) Denied
Records access within 4 hours Extended to 24 hours
Consistent record format Denied
Authority to verify keeping of records Denied
Authority to enforce requirement Only (mostly enforceable) “prohibited act”


In sum, the theory after 9/11 was that the agency needed rapid access to complete and useable records of a food’s origins and movements, to deter and react to a terrorist attack.
What it ended up with was a requirement for partial records, made available in no particular hurry, from some people but not others, without a requirement that a given shipment be well identified, and in a format that could (and does) include the back of a plain brown paper bag. Further, the word quickly went out among the industry that FDA could only check on a firm’s adherence to the recordkeeping requirement if a food connected to the firm was the subject of a serious (“Class I”) recall and that the firm was unlikely to be punished if it ignored the recordkeeping requirement entirely.
One reason that the recordkeeping requirements were so watered down was the fear that they would be too costly for the food industry, with some estimates that the rules could cost processors $140 million per year. But, of course, the produce industry lost that much in the 2006 E Coli outbreak and is on track for similar losses in the ongoing Salmonella Saintpaul investigation. While our reluctance to impose regulatory costs is understandable, it may also be contributing to an ineffective regulatory structure and, in turn, the destruction of industries that rely on regulators to make rapid and accurate decisions about public health threats.


TK: Fast forward to next year; given the version of events prevented above - and the timeworn but true "you are only as strong as your weakest link" adage - it makes sense for the industry to agree to a deadline for mandatory supply chain implementation of the Produce Traceability Initiative.