Saturday, July 11, 2009

Transparency 101: A Primer for FDA

July 11, 2009

The new kids on the block in Washington, DC have made much of their intention to promote "transparency and openness in government". It seems, though, that FDA needs some help to figure out what "transparency" and "openness" mean.

transparency: characterized by visibility or accessibility of information especially concerning business practices (from Merriam-Webster Online Dictionary)

openness (derivative of open): completely free from concealment, exposed to general view or knowledge (from Merriam-Webster Online Dictionary)

For example, openness and transparency mean:
  • Releasing the entire inspection report for Nestlé's Toll House cookie dough production facility, not just a one-page summary for an investigation that took two weeks to carry out
  • Releasing the results of lab tests, including the genetic fingerprints of the strains of E. coli that were found in the cookie dough
  • Explaining what additional steps FDA and Nestlé have taken – or plan to take – to find the source of the contamination (such as investigating all of suppliers of ingredients for Toll House cookie dough)
  • Describing how Nestlé plans to change its procedures or processes in order to prevent a repeat of their contamination problem
  • Releasing a full list of retail consignees of the recalled Toll House cookie dough (as USDA does for meat recalls) rather than relying solely on individual retailers to inform their customers of the recall

According to the one-page summary report released by FDA, inspectors found only two relatively minor deficiencies in the Toll House production plant during their two-week investigation. Yet raw cookie dough that was manufactured in that facility contained enough E. coli O157:H7 contamination to sicken 74 people in 32 states, and send 34 of the victims to hospital. Furthermore, the strain of E. coli o157:H7 that FDA recovered from a sample of cookie dough as part of its investigation did not match the outbreak strain found in all 74 outbreak victims, and a third E. coli strain (not O157:H7) was recovered from a sample of raw cookie dough obtained from an outbreak victim.

This doesn't add up. Multiple strains suggest either a recurring source of contamination – perhaps from a particular ingredient supplier – or a long-standing build-up of contaminants over time. What have Nestlé and FDA missed? What leads are they still following up? Or has the plug been pulled on this investigation? We won't know unless and until more information is released.

Consumers have the right to know what is being done to protect the safety of their food supply. But until FDA figures out how to follow through on this Administration's promise to provide the public with complete and timely information, "transparency" and "openness" will remain nothing more than words in the Merriam-Webster dictionary.

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