Vibrio

FDA Raw Oyster Ban

The latest move by the FDA to ban the sale of raw oysters has met with a flurry of protests from shellfish producers, restaurateurs and legislators, forcing the agency to pull back temporarily.

In a news release issued on November 13, 2009 the FDA outlined the steps it would be taking to further study this issue, including its intent to go back and work with the Interstate Shellfish Sanitation Conference (ISSC).

On November 17, 2009 Congresswoman Rosa L. DeLauro (D-CT) sent a letter to the
Government Accountability Office requesting an independent audit of the ISSC risk management plan for Vibrio vulnificus (Vv) "to determine whether the risk management plan being used by the oyster industry, and promoted by the ISSC, is effective in reducing illnesses and death due to oysters contaminated with the Vv bacteria."

In spite of the FDA's back-pedaling, it is clear the agency still intends to push ahead on the mandated processing of warm-water oysters. We view this as the first step in implementing the agency's stated policy of discouraging the consumption of raw oysters.

While the Gulf industry has been effective at convincing their Congressional representatives of the need to engage on this issue, it has been a harder sell for East Coast and West Coast industry members because many do not see this as an immediate threat. This is a mistake! The way the FDA has written the guidance on Vv mandates that any state with two occurrences of Vv since 1996 must formulate a Vv Management Plan. Most East Coast states have had at least one Vv illness, and several related to V. parahemolyticus, so it is simply a matter of time before mandated processing of summer shellfish becomes a requirement for most of us.

As an industry we are still formulating strategies on how best to proceed, but we will surely need your help on this front. Stay tuned to these pages for updates as the situation develops.

For more information, read our Vibrio Fact Sheet.

To learn about how shellfish harvesters can minimize illnesses associated with Vibrio, read our Vibrio Harvest Brochure.

View our rack card with Transportation Tips for Perfect Shellfish.

View a slide presentation on Vibrio Management (in pdf format) presented at the 2010 Milford Aquaculture Seminar.

Read a summary of the Vibrio Education Workshops that were held in the summer of 2010 at various locations.

Download a sample letter in MS Word format asking your elected representatives to prevent the FDA from mandating Post Harvest Processing.

Vibrio Timeline

November 9, 2009 - Senate bill S.2752 "to ensure the sale and consumption of raw oysters and to direct the Food and Drug Administration to conduct an education campaign regarding
the risks associated with consuming raw oysters" is read twice and referred to the the Committee on Health, Education, Labor, and Pensions.

November 6, 2009 - 18 Congressional representatives sign a letter to FDA Commissioner Margaret Hamburg voicing concern over the agency's proposed post-harvest processing mandate.

November 5, 2009 - Senate bill S.2735 "to prohibit additional requirements for the control of Vibrio vulnificus applicable to the post-harvest processing of oysters" is read twice and referred
to the Committee on Health, Education, Labor, and Pensions.

November 4, 2009 - House bill HR.4022 "to prohibit additional requirements for the control of Vibrio vulnificus applicable to the post-harvest processing of oysters" is introduced and referred to the Committee on Energy and Commerce.

November 2, 2009 - ISSC responds to FDA's plan to reformulate Vv policy in a letter to Deputy Director Kraemer.

October 22, 2009 - Representatives of the East Coast Shellfish Growers Association, Pacific Coast Shellfish Growers Association, Gulf Oyster Industry Council and the Franklin County Oyster & Seafood Task Force issue a press release describing how the FDA's ban on raw oysters could devastate thousands of Gulf Coast workers and threatens other regions.

October 20, 2009 - ECSGA Executive Director Bob Rheault files his report on the reaction to the new FDA directive that "circumvents decades of cooperative negotiations between the industry, state regulators and the FDA."

October 17, 2009 - The Food and Drug Administration (FDA) drops a bombshell on attendees at the biennial meeting of the Interstate Shellfish Sanitation Conference meeting in Manchester, NH. Michael R. Taylor, Senior Advisor to the FDA Commissioner, tells attendees in his opening remarks that the FDA's job is to set national standards ensuring food safety in interstate commerce by "preventing hazards from entering the food supply."
Taylor explains that the FDA plans to mandate that "when raw oysters are harvested in waters and at times where V. vulnificus is reasonably likely to occur, the appropriate preventive measure is one of the available, validated post-harvest processing methods, or another control measure that can be validated to be equally effective."

October 17, 2009 - FDA releases a "backgrounder" explaining the rationale behind the ban.

October 16, 2009 - FDA issues a letter to ISSC members informing them of its new mandate.

April 9, 2009 - The Centers for Disease Control reports in a press release that the incidence of foodborne illness caused by Vibrio spp. over the past three years did not change significantly when compared to the previous three years (2005-2007).

June 5, 2008 - The ISSC executive board approves recommendations regarding Vibrio parahaemolyticus and Vibrio vulnificus. ISSC publishes the Vibrio parahaemolyticus Control Plan Guidance Template.

January 26, 2007 - Fisheries/Aquaculture Specialist Michael J. Oesterling of the Virginia Institute of Marine Science files his report on the Vibrio parahaemolyticus meeting sponsored by the ISSC and the FDA.

April 19, 2005 - ECSGA issues its Vibrio action letter.