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Publisher’s Platform: FDA and the ‘Mosaic Theory’

In the quiet between Christmas and New Years, the FDA released an environmental assessment conducted in response to a multi-state foodborne disease outbreak involving 33 cases of E. coli O145 infections in five states in the spring of 2010. The CDC’s 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). However, the FDA conducted a traceback investigation from the processor (Freshway) that led to the farm (FDA does not name).

This Environmental Assessment by the FDA identified the mystery farm upon which the lettuce was grown as the most likely source of the contamination. The FDA did confirm that the suspect romaine lettuce was grown in four fields on a farm in Wellton, Arizona. The environmental assessment 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.

Yet, the FDA refuses to name the farm. Why?  It is not like the FDA has not named farms in past outbreaks. Here are links to three CDC, FDA and the state of California investigations and tracebacks on past E. coli O157:H7 outbreaks:

2006 Dole SpinachThe CDC confirmed 205 persons with illness associated with Dole Spinach E. coli O157:H7 outbreak in California, Arizona, New York, Minnesota, Wisconsin, Oregon, Utah, Colorado, Washington, Michigan, Ohio, Pennsylvania, Virginia, Idaho, New Mexico, Connecticut, Illinois, Indiana, Kentucky, Maine, Nebraska, Nevada, Tennessee and Wyoming.

2006 Taco Bell LettuceThe CDC confirmed 71 persons with illness associated with the Taco Bell restaurant E. coli O157:H7 outbreak in New Jersey, New York, Pennsylvania, Delaware, and South Carolina.

  

2007 Taco John’s LettuceThe CDC confirmed 81 persons with illness associated with the Taco John’s restaurant E. coli O157:H7 outbreak in Iowa and Minnesota.

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?

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.

© Food Safety News
  • Jess C. Rajan, Ph.D.

    FSIS is conducting veterinary drug residue analysis in animals used for human food under a 1984 Memorandum of Understanding (MOU) with the FDA. Detailed information on the sources of the animals with violative levels of chemical residues is published on the FSIS website.
    http://www.fsis.usda.gov/PDF/Residue_011311.pdf
    Most of these animals with alleged violative chemical residues come from dairy farms regulated by the FDA.

  • Thanks, Bill, for bringing this to our attention. I have no question that I would never have heard of it otherwise.
    And my thanks to the FDA continuing to not blemish its record by implementing wise policy.
    There are so many reasons that this is bad food safety policy that to list and describe them fully would take pages. I will highlight only a few.
    The FDA’s action illustrates clearly the FDA’s capacity to thwart the clear legislative intent of Congress. One the major goals of the traceback system mandated by both the 2002 Bioterrorism Act and the Food Safety Modernization Act (FSMA) is accountability. This action by the FDA clearly impedes accountability.
    The unnamed farm might also be selling through other distribution networks or looking to expand its distribution. Those wholesale buyers certainly would want to know of the connection of the farm to this serious outbreak so they can take extra precautions to assure the safety of the food the unnamed farm sells them.
    I hope that all of the plaintiffs involved will refuse to settle unless the name of the farm involved is made public. Of course, doing so would further support Sen. Coburn’s assertion that American has the safest food in the world because it has the best legal system.
    Also, the FDA has inadvertently shown clearly the validity of a key part of the rationale of the Tester-Hagan amendment to the Food Safety Modernization Act—full transparent traceback and accountability in the marketplace. As we have emphasized again and again. No grower/farmer producing food for local consumption could ever get away with such a high-handed refusal.
    Contrast this with the impact on Bravo Cheese and Costco.
    This is what comes from the failure of Congress and the supporters of the FSMA to hold the FDA accountable for its poor performance. And, isn’t it an interesting coincidence that the report came out shortly AFTER the FSMA was passed and not before it was voted upon.
    This disgusts me.

  • Thanks, Bill, for bringing this to our attention. I have no question that I would never have heard of it otherwise.
    And my thanks to the FDA continuing to not blemish its record by implementing wise policy.
    There are so many reasons that this is bad food safety policy that to list and describe them fully would take pages. I will highlight only a few.
    The FDA’s action illustrates clearly the FDA’s capacity to thwart the clear legislative intent of Congress. One the major goals of the traceback system mandated by both the 2002 Bioterrorism Act and the Food Safety Modernization Act (FSMA) is accountability. This action by the FDA clearly impedes accountability.
    The unnamed farm might also be selling through other distribution networks or looking to expand its distribution. Those wholesale buyers certainly would want to know of the connection of the farm to this serious outbreak so they can take extra precautions to assure the safety of the food the unnamed farm sells them.
    I hope that all of the plaintiffs involved will refuse to settle unless the name of the farm involved is made public. Of course, doing so would further support Sen. Coburn’s assertion that American has the safest food in the world because it has the best legal system.
    Also, the FDA has inadvertently shown clearly the validity of a key part of the rationale of the Tester-Hagan amendment to the Food Safety Modernization Act—full transparent traceback and accountability in the marketplace. As we have emphasized again and again. No grower/farmer producing food for local consumption could ever get away with such a high-handed refusal.
    Contrast this with the impact on Bravo Cheese and Costco.
    This is what comes from the failure of Congress and the supporters of the FSMA to hold the FDA accountable for its poor performance. And, isn’t it an interesting coincidence that the report came out shortly AFTER the FSMA was passed and not before it was voted upon.
    This disgusts me.