FDA May Delay Oyster Rule after Industry Pressure

In response to industry and political pressure [1], the Food and Drug Administration may be backing away from a regulation that would require oyster sellers to process oysters to kill Vibrio vulnificus, a bacteria that can sicken or kill those it infects. The regulation was supposed to take effect in 2011, but FDA may delay action while it further studies the issue.

From FDA’s statement [2], issued Friday:

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011. These are legitimate concerns.

It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal. Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way. 

Since the regulation is not supposed to take effect for almost two years, FDA could conceivably wrap up the study and proceed as planned. This could just be an announcement intended to get industry and Gulf state lawmakers off the agency’s back.

Of course, it could also be a fatal blow to a potentially life-saving policy. As we all learned in Season 3 of Mad Men, delay can be a powerful tactic in politics (1:45 mark if you're impatient):

President Obama promised an end to special interest, backroom dealings in the Executive Branch; but FDA’s announcement smacks of a Bush administration-esque concession. The Center for Science in the Public Interest (CSPI) has been pushing for the FDA oyster rule. CSPI senior staff attorney David Plunkett had this to say [3]:

A group of Gulf Coast Senators and Representatives weighed in on the side of a small but vocal industry in their states and won. Unfortunately this political victory for the Gulf Coast oyster industry is a health tragedy for their customers, and the action condemns scores of consumers to serious illness and death from this potent pathogen. This small portion of the shellfish industry should not have a free pass from FDA to sell adulterated and potentially deadly oysters to the public.