Chloramphenicol  and Phenicols in Foods

ADPEN is currently utilizing the validated FDA LC/MS/MS methods  which can detect down to 0.3 ppb for seafood and honey.  ADPEN has also validated a modification of this method for use in milk by products and other matrices.   ADPEN can also provide rapid tests for chloramphenicol using ELISA for screening purposes, for Customs Detention.  Confirmation of any positives would be done by LC/MS/MS.

ADPEN can help food companies implement proactive food safety monitoring programs in order to mitigate the risk and to protect consumers as well as corporate reputations.    

FDA INCREASES SAMPLING OF IMPORTED SHRIMP, CRAYFISH (CRAWFISH), HONEY AND MILK PRODUCTS
 

The Food and Drug Administration (FDA) has increased the sampling of imported shrimp, crawfish, honey, royal jelly, feed and milk products for the presence of chloramphenicol. FDA is taking this action because low levels of chloramphenicol have been detected in the U.S. and other countries in imported shrimp, crayfish, honey and other foods.

Chloramphenicol is a potent, broad-spectrum antibiotic drug and a potential carcinogen used only at therapeutic doses for treatment of serious infections in humans. Due to the unpredictable effects of dose on different patient populations, it has not been possible to identify a safe level of human exposure to chloramphenicol. Therefore, Federal regulations in the United States, Canada and the European Union prohibit its use in food producing animals and animal-feed products, including honey bees. 

The FDA is concerned about any detection of chloramphenicol in foods, according to Dr. Lester M. Crawford, FDA Deputy Commissioner. "The Agency will take whatever action is necessary to protect the public health."  Therefore there is a zero tolerance for chloramphenicol in food.  FDA is requiring testing for chloramphenicol to be one using FDA's LC/MS/MS method validated down to 0.3 ppb.   But any confirmed residue below this level is considered food contamination. 

Until recently the sensitivity of the methodology to detect chloramphenicol in shrimp could find the drug down to the 5 parts per billion (ppb) level. Recently Canada and the European Union (EU) have refined their LC/MS/MS methods to detect even lower levels and have taken action on food products from China and Vietnam found to be contaminated by chloramphenicol. The FDA has also modified and validated its LC/MS/MS methodology to confirm chloramphenicol levels in shrimp, crayfish and honey to 0.3 ppb this places the U.S. methodology in line with Canada and the EU.   ADPEN Laboratories has validated a modification of the FDA method for the analysis of milk related products by LC/MS/MS down to 0.3 ppb.

The new LC/MS/MS methodology for testing for chloramphenicol to the level of 0.3 ppb will be used to test imported foods that are suspected to contain chloramphenicol. FDA will detain and refuse entry to any product suspected of as containing chloramphenicol unless testing is done according to their guideline and is free of chloramphenicol.   Since LC/MS/MS is the only instrument able to attain the sensitivities required of 0.3 ppb, HPLC, GC/MS  are not suitable or acceptable and cause false positives.  Residues below 1 or 2 ppb would not be detected with HPLC, but would be found by the FDA's LC/MS/MS method.  FDA will take action against violative products by impounding and destroying the contaminated product.  The FDA continues to work with other governments and state agencies to insure the safety of the U. S. food supply.

The Canadian Food Inspection Agency (CFIA) has also detected chloramphenicol contamination in samples of honey imported from China.  Consequently  the CFIA has issued several health hazard alerts warning Canadians not to consume Chinese honey.  Honey available in Canada and the United States could be a blend of products from China and other sources.

Chloramphenicol has been detected in food from China, Vietnam, Indonesia, Thailand, Vietnam, India, Bangladesh and Mexico.

FDA Seizes Adulterated Crabmeat in Louisiana
Product Contains Chloramphenicol and Poses Unacceptable Risk

At the request of the Food and Drug Administration (FDA), U.S. Marshals seized approximately 1,144 cases of Bernard's brand frozen crabmeat, while it was being held for sale at Southern Cold Storage Company, Baton Rouge, La, on July 2, 2004 because it was adulterated with an unapproved food additive, chloramphenicol.

The U.S. Marshals seized approximately 304 cases of pasteurized special white crabmeat; 200 cases of pasteurized special claw crabmeat; and 640 cases pasteurized jumbo lump crabmeat. Imported from China, the frozen crabmeat can be identified by lot number 1302 with the sell by date of January 18, 2007. The seized crabmeat has an estimated value of $86,944.

In accordance with the Federal Food, Drug and Cosmetic Act, food products that contain chloramphenicol are adulterated and are not permitted to be sold in or imported into this country.

Chloramphenicol is a broad-spectrum antibiotic drug used to treat life-threatening infections in humans, usually when other alternatives are not available. The use of this antibiotic is limited because of its potentially life-threatening side effect, idiosyncratic aplastic anemia. For the very small number of the population susceptible to this side effect, exposure to chloramphenicol could be serious or life threatening. Because of the current uncertainty regarding the dose-response relationship between chloramphenicol ingestion and aplastic anemia, it is not possible to define a safe level for the presence of this antibiotic in food products.

In June 2002, FDA announced increased sampling of imported seafood for the presence of chloramphenicol. This action was taken because some states and other countries detected low levels of chloramphenicol in imported shrimp and crayfish.

The agency will continue to detain or seize any food imports that contain chloramphenicol to ensure that this product is not released for human or animal consumption in the United States.

For more information please call (904) 645-9169