Import Alert 16-136: Detention without physical examination of aquacultured shrimp and prawn products in all market forms from Peninsular Malaysia due to the presence of unapproved animal drugs or unsafe food additives

As the aquaculture industry continues to expand, concerns regarding the use of unapproved animal drugs and unsafe chemicals, and the misuse of approved animal drugs during aquaculture production has increased significantly. The existing scientific evidence demonstrates that the administration of pharmacologically active compounds during the various aquaculture life-cycle stages can result in the presence of residues in the edible portion of the finished seafood products. The consumption of these products may have an adverse impact on human health. A public health concern exists regarding prolonged exposure to nitrofurans and chloramphenicol, broad-spectrum antimicrobial drugs used in food-producing animals. Residues of these drugs in food products may present a potential health risk to consumers. These compounds are known to have carcinogenic and genotoxic properties. Also, the introduction of these residues into the food supply can contribute to the development and spreading of antimicrobial-resistant (AMR) bacterial strains. These resistant pathogens may be transferred to and cause infections in humans, compromising the effectiveness of critical antimicrobial treatments vital to human medicine.(see 21 C.F.R. 510.110(c)). Based on a robust body of scientific evidence, the FDA has determined that the detection of parent compounds or metabolite marker residues of nitrofurans and chloramphenicol in shrimp is directly linked to the administration of these prohibited veterinary drugs during the aquaculture production stages (i.e., hatcheries, farms).

Nitrofurans and chloramphenicol are classified as drugs under Section 201(g)(1) of the FD&C Act when intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of aquacultured shrimp or prawns. Because they are not generally recognized as safe and effective for these purposes, they are considered "new animal drugs" under Section 201(v)(1). Pursuant to Section 512(a)(1), the use or intended use of a new animal drug requires an approved new animal drug application, conditional approval, or index listing. The FDA has not approved any of these applications for the use of nitrofurans or chloramphenicol in shrimp or prawns. Therefore, these substances are considered to be unsafe new animal drugs within the meaning of section 512(a)(1). Consequently, the presence of these parent drugs or their metabolite conversion products in processed shrimp or prawns renders the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA has determined that using nitrofurans or chloramphenicol at any life stage of an animal results in residues in the final edible products. Because these substances are not generally recognized as safe for human consumption, any residues not classified as "new animal drugs" are deemed food additives under Section 201(s) of the FD&C Act. Under Section 409, food additives are considered unsafe unless the FDA has issued a specific regulation or exemption authorizing their safe use. No such regulations or exemptions exist for nitrofurans or chloramphenicol in food-producing animals. Because these residues present clear human food safety risks, they are classified as unsafe food additives. Consequently, the presence of nitrofuran or chloramphenicol residues in food, including shrimp and prawns, renders the product adulterated under Section 402(a)(2)(C)(i) of the FD&C Act and subjects it to regulatory action.

From October 1, 2014, through September 30, 2015, FDA detected a significant increase in the presence of nitrofurans and chloramphenicol residues in shrimp products imported from Peninsular Malaysia. During that period, FDA sampled and tested 138 shrimp shipments from Peninsular Malaysia. Of those collected, forty-five samples (32%) tested positive for the presence of nitrofuran residues (residues of furazolidone metabolite AOZ) and/ or chloramphenicol residues. The concentrations of nitrofuran residues detected in shrimp ranged from 1.0 ppb to 23 ppb, and the concentrations of chloramphenicol residues in shrimp ranged from 0.3 ppb to 6.8 ppb.

ENDNOTES:

1. "Shrimp" and "prawns" are common names (not scientific names) and are often used interchangeably by importers.

2. FDA has prohibited food production uses of chloramphenicol in animals since 1984. See 49 Fed. Reg. 20915 (May 17, 1984). FDA withdrew new animal drug applications for nitrofurans (furazolidone and nitrofurazone) in 1991 based on its finding that these drugs were no longer shown to be safe under the conditions of use for which they were approved. 56 Fed. Reg. 41902 (Aug. 23, 1991). There are very few approved animal uses of nitrofurans in the U.S. Product approvals are restricted to topical formulations designated solely for non-food producing animals only, i.e., cats, dogs and horses. Both chloramphenicol and nitrofurans are prohibited from extra-label use in food producing animals, including seafood. See 21 C.F.R. 530.41(a)(1), (7)-(8).

3. Section 201(s) of the FD&C Act defines "food additive" as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . if such substance is not generally recognized . . . as safe under the conditions of its intended use."

4. Chloramphenicol residues may cause serious human blood disorders, including aplastic anemia, and other serious toxic effects. In the context of a new animal drug application withdrawal, the Director of the Center for Veterinary Medicine concluded that "use of chloramphenicol in food-producing animals causes a risk to human health" and that "[a]ny such risk is unacceptable." See 50 Fed. Reg. 20759 (July 1, 1985).