Personal Injury Law

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

By Bill Marler, Esq.

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).

This 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.'

Well, so much for transparency.

Full post as published by Marler Blog on January 14, 2011 (boomark / email).