viernes, 28 de septiembre de 2018

FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela

FDA

FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multi-state outbreak of Vibrio parahaemolyticus illnesses that was linked to fresh crab meat.
Update – September 27, 2018
As of September 27 2018, a total of 26 laboratory-confirmed cases of Vibrio parahaemolyticus infection were reported in people who ate fresh crab meat from Venezuela; the cases were reported by seven states and the District of Columbia.
This outbreak investigation has ended. Processors and distributors should know that the FDA’s Bacterial Analytical Manual (BAM) states that “A heat-processed product should not contain viable V. parahaemolyticusand if so, would indicate a significant problem in manufacturing practices or post-process contamination.” FDA has additional information for processors and distributors in the new section, “What should processors and distributors know?”
Recommendations
Consumers and restaurants may want to consider using pasteurized crab meat or fully recooking (bringing to an internal temperature of at least 165°F) fresh crab meat, particularly for items that will be served cold.

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (illness or serious allergic reaction), you can
Visit www.fda.gov/fcic for additional consumer and industry assistance.

What's the Problem and What's Being Done?

  • The U.S. Food and Drug Administration worked with federal, state, and local officials regarding a Vibrio parahaemolyticus outbreak linked to fresh crab meat from Venezuela. This crab meat was labeled as “fresh” or “pre-cooked” and is a ready-to-eat (RTE) product.
  • Bacterial isolates from twelve cases have been analyzed through Whole Genome Sequencing (WGS), a type of DNA testing that reveals the genetic makeup of an organism. Through this testing, it was confirmed that all twelve isolates analyzed are genetically related to each other. Nine people (36%) were hospitalized. Illnesses onsets ranged from April 1, 2018 to July 19, 2018.
  • On July 13, 2018, the FDA advised consumers to avoid eating fresh crab meat from Venezuela, as it may have been contaminated with Vibrio parahaemolyticus.
  • The outbreak investigation is over. The FDA’s Bacterial Analytical Manual (BAM) states that a heat-processed product should not contain viable Vibrio parahaemolyticus. Consumers and restaurants can consider taking additional safety measures by using pasteurized crab meat or recooking fresh crab meat, particularly for items that do not have further cooking, such as cold dishes.
  • The FDA collaborated with state partners in conducting a traceback investigation. This investigation identified multiple Venezuelan processors that supplied multiple brands of crab meat during the outbreak. FDA’s traceback did not identify a single firm as the source of the outbreak.
  • As a result of the outbreak investigation, the FDA increased testing of fresh crab meat from Venezuela. The FDA did not identify Vibrio parahaemolyticus in any samples tested, but the FDA did identify Salmonella and Listeria monocytogenes in some crab meat samples collected at import. The affected products did not enter into U.S. commerce.

What is Vibrio parahaemolyticus?

Vibrio bacteria naturally live in certain coastal waters and are present in higher concentrations between May and October when water temperatures are warmer. About a dozen Vibrio species can cause human illness, known as vibriosis. Vibrio parahaemolyticus is one of the most common species causing human illness in the United States.
Most people infected with Vibrio parahaemolyticus develop diarrhea, vomiting, abdominal cramps, nausea, fever and stomach pain. Diarrhea tends to be watery and occasionally bloody. 

How Soon After Exposure do Symptoms Appear? 

Most people infected with Vibrio parahaemolyticus develop symptoms after approximately 24 hours, but timing can vary.

Who is at Risk?

Anyone who consumes raw or undercooked shellfish is at risk of contracting Vibrio parahaemolyticus; however, the product under investigation was a fresh, pre-cooked product that may be served chilled or lightly re-heated in various dishes. Children younger than five, the elderly, and people with weakened immune systems are more likely to have severe infections.

What Do Restaurants and Retailers Need To Do?

Restaurants and retailers may want to consider using pasteurized crab meat or recooking fresh crab meat, particularly for items that do not have further cooking, such as cold dishes.
Restaurants and retailers should also be aware that the fresh crab meat may be a source of pathogens and should control the potential for cross–contamination of food processing equipment and the food processing environment. They should follow the steps below:
  • Wash hands with warm water and soap following the cleaning and sanitation process.
  • Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products.
  • Retailers that have sold bulk product should clean and sanitize the containers used to hold the product.
  • Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross–contamination. 

What Do Consumers Need To Do?

Consumers may want to consider using pasteurized crab meat or recooking fresh crab meat, such as cold dishes.
People who think they might have become ill from eating possibly contaminated crab meat should talk to their health care providers.
Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food.
For general food safety advice regarding fish and shellfish, here are some steps you can take to prevent Vibrio:
  • When ordering shellfish in restaurants, ask that they be fully cooked unless they have been treated (and labeled as such) with a method to reduce Vibrio (such as pressure treatment).
  • Keep raw foods from touching cooked foods and surfaces used for cooking and eating. 

What Should Processors and Distributors Know?

Processors and distributors should know that the FDA’s Bacterial Analytical Manual (BAM) states that “A heat-processed product should not contain viable Vibrio parahaemolyticus and if so, would indicate a significant problem in manufacturing practices or post-process contamination.” Vibrio parahaemolyticus is an extremely heat sensitive pathogen that will become non-detectable after being properly cooked. Several previous outbreaks linked to cooked RTE crab meat were associated with insanitary conditions after cooking, such as cross-contamination by live crabs or seawater.
FDA notes that its seafood HACCP regulation includes requirements for seafood processors to monitor conditions and practices to prevent cross-contamination (21 CFR 123.11(b)(3)) and to monitor the safety of the water that contacts food or food-contact surfaces (21 CFR 123.11(b)(1)).
Appendix 5 of FDA’s 4th edition of the Fish and Fishery Products Hazards and Controls Guidance (Guidance) contains information regarding a “safety level” for Vibrio parahaemolyticus in RTE fishery products that is above the detectable level. FDA notes that, as stated in the Guidance, the levels in the Guidance do not bind FDA or the public. FDA is in the process of reevaluating the Guidance related to the presence of Vibrio parahaemolyticus in cooked RTE crab meat and will take action on a case-by-case basis to protect public health.  

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