Header graphic for print
Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

FDA Environmental Assessment of 2010 E. coli O145 Freshway Lettuce Outbreak Linked to Unnamed Arizona Farm

Readers of my blog might well remember the CDC, FDA and the State of California investigations and tracebacks on E. coli O157:H7 outbreaks:

2006 Dole Spinach

2006 Taco Bell Lettuce

2007 Taco John’s Lettuce

Interesting thing about those investigations is that the FDA, et. al, named all names – including the farms that grew the offending lettuce or spinach.  Why not now?

This Environmental Assessment was conducted in response to a multi-state foodborne disease outbreak CDC investigation involving 33 cases of E. coli O145 infection in five states in the spring of 2010. An epidemiologic investigation found that the illnesses were associated with the consumption of shredded romaine lettuce processed at one firm (Freshway) in Ohio. FDA’s investigation at the processor did not identify a likely source of contamination at the firm (Freshway). FDA conducted a traceback investigation from the processor that led to the farm (FDA does not name).

Screen shot 2011-01-14 at 12.05.44 PM.pngThis Environmental Assessment was preceded by an epidemiological and traceback investigation and regulatory inspection of the processor (Freshway) of the produce implicated in the investigation, the results of which identified the farm (FDA does not name) upon which the lettuce was grown as the most likely source of the contamination.

Nonetheless, FDA has made no definitive determination regarding how or at what point in the supply chain E. coli O145 contaminated the lettuce associated with the outbreak. The suspect romaine lettuce was grown in four fields of a farm in Wellton, Arizona.

The subsequent environmental assessment initially identified six potential sources of STEC in the Wellton, Arizona area; three Concentrated Animal Feeding Operations (CAFOs), one housing development with a co-located sewage treatment facility, one recreational vehicle (R.V.) park with multiple septic leach systems, and the seasonal grazing of sheep on harvested wheat and alfalfa fields.

Here is the FDA’s rationale for not disclosing the name of the farm:

FDA has concluded that the supplier/customer relationship between the farm and the distributor is confidential commercial information (CCI). Utilizing the “mosaic effect” approach recognized by the courts, FDA must consider that the distributor has already been publicly identified in the lettuce recall. As a result, if FDA were to disclose the name of the source farm, it would necessarily reveal the supplier/customer business relationship between the farm and the distributor. CCI is exempt from FOIA’s disclosure obligations under 5 U.S.C. 552(b)(4); and the Trade Secrets Act, 18 U.S.C. 1905, prohibits individual government employees from disclosing CCI “to any extent not authorized by law.”

To be blunt, I do not fully understand this argument in the context of the disclosure of the farm in the Freshway outbreak. The FDA’s explanation for non-disclosure of the farm is basically non-existent.

In the general legal context, the “mosaic” theory is most often invoked in national security or defense type matters. This article explains it very well – “The Mosaic Theory.”

“The theory is straightforward: seemingly insignificant information may become significant when combined with other information. “Thousands of bits and pieces of seemingly innocuous information can be analyzed and fitted into place to reveal with startling clarity how the unseen whole must operate” (Halkin v. Helms, 598 F.2d 1, 8, D.C. Cir. 1978).”

As I understand it, the distributor in the lettuce outbreak has been identified (Freshway), and if FDA named the Farm, it would reveal that there is a business relationship between Freshway and the Farm. FDA considers their business relationship to be “confidential commercial information” protected from disclosure under FOIA. I think this is because either the information Freshway provided to FDA to identify the source Farm was designated confidential or FDA otherwise has reason to believe that disclosure of the Farm could reasonably be expected to cause substantial competitive harm to the parties.

In other words, it appears FDA is more concerned with harming the Farm and Freshway’s bottom line, and less with transparency.  Well, so much for transparency.

  • Doc Mudd

    “…if FDA were to disclose the name of the source farm, it would necessarily reveal the supplier/customer business relationship between the farm and the distributor.”
    What are we, back in grade school sitting in the back of science class passing secret notes among the cool girls? What could possibly be the big scandal? Oh, damn, now they’ve got me doing it!

  • Gabrielle Meunier

    Isn’t this what Traceback is about — transparency? Is it beneficial to the public if FDA knows but the public doesn’t know? Does the Food Safety Modernization Act address this?