By Ricardo Carvajal -
The D.C. District Court granted FDA’s motion for summary judgment in a lawsuit alleging unreasonable delay in the agency’s response to a citizen petition asking for the inclusion of FDA/EPA’s seafood consumption advisory in seafood labeling and at point-of-sale. Although the petition was filed in July 2011, the court found that “FDA’s delay in responding to Plaintiffs was not so egregious as to warrant intervention at this time.” The court based its finding on a number of factors, including:
- The complexity of the scientific and technical issues involved, including ascertaining the risks of mercury on childhood development in light of the net effects of seafood consumption, as well as ascertaining the pros and cons of placing mercury warnings at point-of-sale;
- The fact that the agency is updating the advisory language of which the citizen petition seeks to compel expanded use;
- The absence of “certain danger” associated with the delay in FDA’s response to the citizen petition; and
- The need for FDA to have flexibility in allocating resources to address issues related to mercury consumption, as well as other priorities.
The court noted that its “calculus may change” once FDA/EPA finalize their update to the advisory, after which “further delay could become unreasonable.” The court therefore urged FDA “to act with alacrity” once that task is completed.
The draft updated advisory and corresponding Q&As are available here, as is a link to submit comments.