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Reasonable Suggestions For
FDA And Industry Methodology

Several Congressional hearings will be held this week related to the Salmonella Saintpaul outbreak. The hearings will focus on various things — trace back, how the FDA has spent a supplemental appropriation, the current state of food safety in the produce industry, etc.

An important subtext of the hearings, though, is to attempt an analysis of what is wrong with the way FDA handles food safety issues and, as a consequence, how we can do it better.

One of the more sensible approaches to this issue was developed by Robert A LaBudde, PhD, PAS, Dpl. ACAFS, of Least Cost Formulations Ltd., which specializes in the development of productivity-improvement techniques and management-decision support systems, especially for the food blending industry:

Any study of control theory knows that a process control system requires the following steps:

1. Measure the output.

2. Have targets (aka standards) for the output.

3. Compare the measurement to the targets to determine the direction and size of the correction needed.

4. Have a predetermined plan of action.

5. Select and implement the action (correction), based upon the comparison.

In the produce area, here tomatoes, FDA fails completely on each of these steps. They don’t measure the Salmonella contamination of tomatoes on a regular basis to say what the incidence rate is. They don’t have rational targets desired, other than zero tolerance. They have no plan of action, other than shutting down the entire industry.

FDA and USDA would both prefer “risk-based inspection”, which is bureaucratese for “cut measurement even further”. The “risk” is not a measured, empirical risk, but instead some hypothetical, static risk ascertained in some one-time theoretical study. Real “risk-based inspection” would make measurements of actual incidence, and allocate resources to reduce that incidence. Instead, resources are allocated based upon hypothetical behavior patterns with presumed association with incidence.

What should the FDA be doing?

1. Require the industry to conduct self-inspection of pathogen incidence of outgoing product. Although this would not be at a sufficient level to supply much confidence in a particular lot, over time it would provide confidence in the system, and a measurement of incidence rate with confidence interval.

As I have mentioned before, even a single sample tested once each week, with a composite made of all production for that week, would be sufficient to provide steering information and provide some confidence operations are not completely in shambles.

2. Use intensified inspection when an outbreak is occurring to discover which producers have degraded performance relative to their former baseline.

3. Allow producers to use intensive inspection results to “get out of the box” with respect to retainage when the source of an outbreak is not yet identified.

4. Allow lot-based inspection to provide assurance that particular production is free of contamination at some rational level.

Experience shows that, when an outbreak level of contamination is present in operations, contamination is pervasive and easy to detect.

Having 60 random samples for one lot or period of production test negative at 1 CFU/25 g would provide good assurance that this production is not capable of producing an outbreak.

5. Maintain traceback capability for samples taken in distribution.

Lots should be marked with a unique producer ID.

Currently FDA has no plan other than to bring an entire industry to a stop. It has no good way to identify source, and no good way to clear producers. This is about as unscientific as it is possible to be, and is an absurd method of regulation.

If FDA’s sole goal is to punish the industry into policing itself, I suppose this plan works for this purpose. If it is to maintain a safe food supply and rapidly identify a source of outbreaks, it is sadly lacking.

If FDA plans to punish industry into self-regulation, it would do better to activate the franchise and retail chains who are industry’s customers. They are much better at creating and enforcing safety regulations than FDA ever could be.

— Robert A. LaBudde, PhD, PAS, Dpl. ACAFS
Least Cost Formulations, Ltd.
Virginia Beach, Virginia

Dr. LaBudde’s plan speaks to many of the problems and provides reasonable solutions. Two key points:

  • Instead of saying that only zero incidence of a pathogen is acceptable, Dr. LaBudde urges a scientific approach to ascertain what the baseline level of contamination is. Once that level is determined — perhaps through required self-inspection of pathogen incidence — targets could be developed to reduce that incidence over time.

  • In the event of an outbreak where the source has not been determined, producers could use intensive inspection to “get out of the box” or be free of an FDA restriction.

This analysis also points to a different way of looking at testing. We ran a piece entitled, A Closer Look At Finished Product Testing, and wrestled with the issue of what role testing should play in light of the fact that it was not financially feasible to do enough finished product testing to statistically validate safety.

Here, however, low levels of testing are being suggested to ascertain an industry baseline and then short term, intense testing to clarify issues and free up product in an outbreak would be followed.

There are many valid suggestions of things that can be done to reform the way produce and the public health systems intersect. Many thanks to Robert A. LaBudde for presenting such a sensible approach.

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