​​California Food Retailers-Limiting the Sale of Raw Oysters Harvested from the Gulf of Mexico California Code of Regulations (CCR) Title 17, Sections 13675 and 13676​​

Prior to CCR Title 17, Sections 13675 and 13676, every year Californians became seriously ill and died after consuming raw oysters harvested from the states bordering the Gulf of Mexico (Alabama, Florida, Louisiana, Mississippi, and Texas), contaminated with the pathogen Vibrio vulnificus (V. vulnificus).​​​​

V. vulnificus bacteria are naturally present in marine environments. But the bacteria are at some of their highest levels in Gulf Coast waters and oysters, especially during the warm summer months.​

From 1983 to 2011, there were 83 illnesses resulting in 50 deaths reported in California that were associated with the consumption of raw oysters containing V. vulnificus. Persons with certain chronic diseases, especially those associated with liver disease are at high-risk. Many people with Vibrio vulnificus infection may need intensive care or limb amputation. Nationally, about 1 in 5 people wi​th this infection die, sometimes within a day or two of becoming ill.​

CCR, Title 17, Section 13675 aims to prevent V. vulnificus illnesses and deaths associated with the consumption of raw Gulf oysters. The most significant portion restricts the sale of raw oysters harvested from the Gulf of Mexico during April 1 through October 31, unless the oysters are treated with a scientifically validated process to reduce the level of V. vulnificus to less than 30 MPN/g. Raw Gulf oysters received during April through October that have not been processed to reduce the level of V. vulnificus to less than 30 MPN/g are considered adulterated.​

Additional Requirements of Title 17, Section 13675 Requires Retailers to:

Provide a written warning, in English and Spanish, to any person who orders raw Gulf oysters as follows:

Warning

This facility offers raw oysters from the Gulf of Mexico. Eating these oysters may cause severe illness and even death in persons who have liver disease (for example alcoholic cirrhosis), cancer or other chronic illnesses that weaken the immune system. If you eat raw oysters and become ill, you should seek immediate medical attention. If you are unsure if you are at risk, you should consult your physician.

Aviso Importante

Esta facilidad ofrece ostras crudas del Golfo de Mexico. A comer estas ostras crudas pueden causar una enfermedad grave y hasta la muerta en las personas que padecen de enfermedades del higado (por ejemplo, cirrosis alcoholica), cancer u otras enfermedades cronicas que debilitan el sistema immunologico. Si usted come ostras crudas y se enferma, debe buscar atencion medica inmediatamente. Si usted cree estar en peligro, debe consultar a un medico.

​Note: Retailers are exempted from these warning requirements when they provide Gulf oysters that have been treated to reduce the level of V. vulnificus to less than 30 MPN/g. However, retailers are reminded that the warnings are required during November through March when raw, untreated Gulf oysters are received and sold by retailers.

Only accept raw shellfish that bears a label or tag that declares a statement of origin (e.g. “Harvested in [State]”). This provision allows Gulf Coast oyster dealers to place a geographical statement of origin (e.g. “Product of the Gulf of Mexico”).

Only accept raw shellstock that bears a label or tag stating:

1. Date of harvest;
   
2. Harvest area;
3. Certificate number established by the state shellfish control authority.

Only accept shucked and half-shell oysters that bear a label or tag stating:

1. Sell by-date, date-shucked, date-packed or other similar date;
   
2. Certificate number of the harvester or dealer. 

This provision requires containers of raw shucked or half-shell Gulf oysters to bear a label declaring the harvest date. However, this requirement is satisfied if the harvest date is supplied on an invoice accompanying each shipment.​

These provisions require retailers to:

• Only accept raw, fresh-shucked oysters that have a tag or label stating they will be cooked before eating.
• Refuse to accept raw, fresh or frozen, shellstock, half-shell or shucked Gulf Coast oysters harvested from April 1 through October 31 unless:
  
• The oysters have been treated by an approved method shown to reduce the level of V. vulnificus to less than 30 MPN/g.
  
• Their container bears a label or tag that clearly and prominently states “Processed to Reduce Vibrio Vulnificus to Non-Detectable levels” and;
• ​The retailer and dealer have on-site and available for inspection a copy of the current letter of verification of the process used to reduce the level of V. vulnificus to less than 30 MPN/g issued by the California Department of Public Health to the dealer.

These provisions also allow dealers who process Gulf oysters with an opportunity to receive verification by the department that the oysters supplied by the dealer are subjected to an oyster treatment process. A dealer who has received a letter of verification is required to provide a copy of the letter of verification to every dealer and retail food facility in California to whom the dealer provides raw Gulf Coast Oysters that have been treated to reduce the level of V. vulnificus to less than 30 MPN/g.​

Dealers that have received verification, shall affix to each container of raw Gulf Coast oysters processed to reduce V. vulnificus to levels less than 30 MPN/g, a tag or label that clearly and prominently bears the statement “Processed to Reduce Vibrio Vulnificus to Non-Detectable levels.”

CCR, Title 17, Section 13676 provides the administrative procedures and timelines for verification requests.

​CDPH is working with retailers and local health departments to implement the requirements of Title 17, Section 13675. If you have any questions regarding this notice contact the California Department of Public Health, Food and Drug Branch (FDB) at 1-800-495-3232.