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Letter To The Honorable Margaret Hamburg, M.D., Commissioner, U.S. Food And Drug Administration


Location: Baton Rouge, LA

Today, Governor Bobby Jindal issued the following letter to the Food and Drug Administration urging officials to reconsider new shellfish policy changes, highlighting the severe impact the new policy would have on the oyster industry.

The Honorable Margaret Hamburg, M.D.

U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

As you are aware, a proposal was announced recently by the FDA at the Interstate Shellfish Sanitation Conference that would be a departure from a previously agreed plan to manage oyster safety. This proposal would place post-harvest processing regulations on Louisiana harvesters which would be disproportionally stringent for our region, and could severely impact other Gulf Coast states' harvesters in Texas, Mississippi, Alabama and Florida.

While we certainly appreciate the enormous task you have in balancing the issue of food safety with access to this very popular food item, we remain committed to the plan agreed to by the FDA and the ISSC, and urge you to consider the validity of this plan before making any changes.

The Louisiana Department of Health and Hospitals, in partnership with the Department of Wildlife and Fisheries, has been a committed partner in the regulation and monitoring of oyster safety. We conduct more than 800 water samplings monthly from throughout the Louisiana Gulf Coast, collect meat samples prior to the opening or reopening of areas that may have been closed for adverse weather or other conditions, and conduct hundreds of shoreline surveys to identify any other risks. In addition, we have moved to implement the best practices outlined in the ISSC/FDA plan, including -- at considerable cost -- moving to refrigerate all oysters for half shell consumption within five hours of harvest during June, July, August and September. Additionally, the time from harvest to refrigeration is expected to decrease to two hours within the next year.

Our oyster industry alone employs more than 3,500 citizens of our state, has an economic impact of several hundred million dollars each year, and has provided a safe, quality product for generations. The capacity to post-harvest process the volume of oysters our fishermen bring to the dock is not in place and would be virtually impossible to implement within the FDA's proposed timetable. Given that this has not been a capital-intensive industry, a substantial investment would have to be made -- thus nearly tripling the cost of the product. The true effect of the proposal, therefore, would be to jeopardize thousands of jobs in Louisiana and all along the Gulf Coast.

Moreover, the FDA's rapid action against domestic oyster production with little public input is a dramatic contrast to the agency's relative inattention to the growing evidence that imported seafood is a far greater public health threat. As you know, imported seafood competes directly with the domestic product, and yet does not meet the same stringent processing and monitoring standards that our own products must meet.

Consumers Union, publisher of Consumer Reports magazine, maintains that, in 2008, the FDA inspected less than one percent of food imports entering the country. In 2008, of the 300 ports in the U.S. where food can enter, only 90 had FDA inspectors stationed at their location. While the FDA inspects this small percentage, the European Union physically inspects 20 percent of fresh, frozen, dried and salted fish and 50 percent of clams and similar shellfish. Japan physically inspected 12 percent of fresh seafood and 21 percent of processed seafood in 2005.

According to the FDA's Web site:

"During targeted sampling, from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood from China was contaminated with antimicrobial agents that are not approved for use in the United States. More specifically, the antimicrobials nitrofuran, malachite green, gentian violet, and flouroquinolones were detected. Nitrofurans, malachite green, and gentian violet have been shown to cause cancer with long-term exposure in lab animals."

And according to testimony by representatives of Consumer's Union before the US-China Economic and Security Review Commission:

"We have considerable evidence that seafood imports from China pose significant safety risks. In June, 2007, the FDA put five types of farmed-raised fish and seafood from China under a "detain and test" order, due to repeated findings that the fish contained chemicals banned from seafood in the United States. We commend FDA for that action, but believe it has only begun to address the problem.

"FDA is actually very limited in what it can do to insure the safety of imports from China or anywhere else. Today, it inspects less than one percent of food imports entering the country. There are over 300 ports (many landlocked) where food can enter. At the peak of its funding, there were FDA inspectors stationed at only 90 of them, and the number of inspectors has dropped since then. This has led to a phenomenon known as "port shopping." Indeed, if a shipment of seafood from China is rejected by FDA inspectors at one port because it has begun to decompose, there is nothing at all to prevent the importer from trying another port where FDA simply may not be present."

While our domestic fisherman, shrimpers, crawfishers and other seafood harvesters have worked with the FDA to deliver a safe and quality product, they struggle to survive in the face of foreign products essentially allowed to enter the country unregulated. With my strong support, our state legislature this year passed a law encouraging labeling of imported seafood for this very reason. This demonstrates our own commitment to protecting the public from products that may be harmful to their health.

We understand that delegates of the Interstate Shellfish Sanitation Conference unanimously voted to keep intact the current Vibrio vulnificus management plan involving strict refrigeration requirements of harvested oysters, as well as to recommend or request the following actions:

* Request that the FDA, in coordination with the ISSC, fund a robust economic impact and consumer acceptance analysis to inform the ISSC deliberations on the proposal.
* Recommend that a workgroup be established to develop criteria for an economic analysis, including a consumer taste acceptance component, and to use the criteria for an economic impact analysis for rulemaking as a guide.
Recommend that the Vibrio Management Committee meet at the Fall 2010 Board meeting of the Executive Board to review the Vibrio vulnificus illnesses following the implementation of the individual Gulf State Vibrio vulnificus risk management plans in Spring 2010.

We support the ISSC positions and recommendations, and must concur with their statement that the FDA's policy contradicts the "spirit of cooperation" between the federal agencies, member states, and the shellfish industry that has existed within the ISSC and NSSP.

Louisiana is committed to working with other states and the FDA to produce the safest and highest quality oyster produce possible. We urge you to reconsider this new shellfish policy change or, at a minimum, implement the ISSC recommendations above before proceeding with any changes. Not only is the oyster industry critical to our economy, it is critical to our state's reputation as the seafood capital of the world. We look forward to working with you and your staff in the weeks to come.


Bobby Jindal
Governor, State of Louisiana

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