FDA Expands Import Alert on Chloramphenicol to Cover All Crustaceans, Including Shrimp
On November 4, 2013, the U.S. Food and Drug Administration (FDA) amended Import Alert 16-127 to now cover all crustaceans contaminated by chloramphenicol. Previously, the Import Alert provided for detention without physical examination of crabmeat and no other seafood products. With the amendment, the Import Alert now covers all crustaceans, including crabs, shrimp, lobster, crayfish, and langostino, contaminated by chloramphenicol.
Under current practice, if a shipper was found to have exported shrimp contaminated with chloramphenicol, the FDA could respond by placing the company on Import Alert 16-124, “Detention Without Physical Examination of Aquaculture Seafood Products Due to Unapproved Drugs.” This Import Alert applied to a wide-variety of drugs, including antibiotics approved for use in some livestock applications but not in aquaculture. A separate Import Alert (16-129) applies to all seafood products (both wild and farm-raised) contaminated by a specific class of antibiotics called nitrofurans.
The amendment to Import Alert 16-127 to now include shrimp emphasizes the special concerns raised by the continued presence of chloramphenicol in imported seafood. As explained by the Import Alert:
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.).
Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia.
Since these adverse reactions are idiosyncratic and are not dose related, no one has yet been able to determine a safe level of exposure to chloramphenicol.
Chloramphenicol is suspected to be a carcinogen and potentially affect the reproductive system in humans.
While seafood contaminated by antibiotics is deemed to be adulterated because it “contains a new animal drug . . . that is unsafe,” crustaceans contaminated with chloramphenicol are deemed to be adulterated because they contain “a poisonous or deleterious substance . . . .”
Remarkably, shrimp continues to be exported that is contaminated with chloramphenicol. Import Alert 16-124 lists fifteen shrimp exporters from three different countries because of the presence of chloramphenicol. Two of those companies were added to the Import Alert in the last five months. The Canadian Food Inspection Agency reports that at least three shippers have been added to their Mandatory Inspection List for the presence of “amphenicols” so far in 2013. Similarly, Japan’s Imported Food Inspection Service has reported finding chloramphenicol in at least four shrimp shipments so far this year, including a shipment of shrimp from a Vietnamese exporter that was added by the FDA to Import Alert 16-124 for chloramphenicol contamination in July.
These consistent findings across regulatory authorities in different markets indicate that chloramphenicol – despite the heightened risks posed by this antibiotic – continues to be used in aquaculture. The move to include shrimp in an Import Alert that formerly only included crabmeat should help to draw more attention to the problem.
Appendix I
Foreign exporters listed, as of November 8, 2013, on Import Alert 16-124 “Detention Without Physical Examination of Aquaculture Seafood Products Due to Unapproved Drugs” (http://www.accessdata.fda.gov/cms_ia/importalert_27.html) for shrimp products contaminated by chloramphenicol are listed below. There are a total of fifteen companies currently listed, of which four are from China, six are from Malaysia, and five are from Vietnam. A Malaysian exporter, Hong San Frozen Foods Sdn. Bhd., and a Vietnamese exporter, Ngoc Tri Seafood Joint Stock, were added to the Import Alert within the last five months.
CHINA
Ningbo Jiuzhou Food Co., Ltd.
Date Published : 09/16/2009
No. 266 Songxi Rd. , Xizhou Town, Xiangshan, CHINA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:10/18/2002
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:10/18/2002
Problems: CHLORAMPHENICOL;
Shantou Dongtao Trade Co., Ltd
Date Published : 09/16/2009
Rm, 1104 Building B, Guoxin Garded , Shantou, CHINA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:11/10/2003
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:11/10/2003
Problems: CHLORAMPHENICOL;
Yelin Frozen Seafood Co.
Date Published : 09/16/2009
Southwest Of Sport Park Shanfen Road, , Shantou, CHINA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:6/23/2003
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:6/23/2003
Problems: CHLORAMPHENICOL;
Zhoushan Guotai Fisheries Co., Ltd
Date Published : 09/16/2009
No 148, Jiefang East Road,Zhoushan , Puxi Development Zone , Zhejiang, CHINA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:10/7/2002
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:10/7/2002
Problems: CHLORAMPHENICOL;
MALAYSIA
HONG SAN FROZEN FOODS SDN BHD
Date Published : 09/06/2013
6 TINGKAT LIMNUNGAN TIGA , TAMAN HONG, CHAIN FERRY , BUTTERWORTH, MY-07 MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 09/06/2013
Desc:Frozen Shrimp
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/06/2013
Desc:Frozen Shrimp
Problems: CHLORAMPHENICOL;
MUTIARA SEAFOOD EXPORTER
Date Published : 03/11/2011
1988 Taman Jaya , KAW. PERINDUSTRIAN RINGAN ASAS JAYA , Bukit Mertajam, MY-07 MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 03/11/2011
Desc:Shrimp
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 03/11/2011
Desc:Shrimp
Problems: CHLORAMPHENICOL;
N.T. Huat Kee Fisheries SDN. BHD.
Date Published : 09/16/2009
2235, Jalan Dato Keramat , Nibong Tebal Pulau , Pinang, My-07 MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:6/11/2009
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:6/11/2009
Problems: CHLORAMPHENICOL;
Seiko Marine Products Sdn Bhd
Date Published : 09/16/2009
No 30, Jalan Meru Indah 20 , Taman Perindustrian Meru Indah , Klang, Selangor, MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:3/17/2008
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:3/17/2008
Problems: CHLORAMPHENICOL;
Soonfroze Corporation Sdn Bhd
Date Published : 09/16/2009
No. 542 Jalan Siakap , Bagan Serai, MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:12/28/2005
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 11/18/2009
Notes:12/28/2005
Problems: CHLORAMPHENICOL;
Straits Sea Foods Trading Co., Sdn. Bhd.
Date Published : 09/16/2009
P.O. Box 166 , 57 Indust Estate , Sarikei, Sarawak, MALAYSIA
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:6/23/2003
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:6/23/2003
Problems: CHLORAMPHENICOL;
VIETNAM
Ngoc Tri Seafood Joint Stock
Date Published : 07/15/2013
3 village, Phong Thanh Dong A Commune , Gia Rai District, Bac Lieu province , 781, VN-55 VIETNAM
16 J – – 05 Shrimp & Prawns
Date Published: 07/15/2013
Desc:Shrimp
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 07/15/2013
Desc:Shrimp
Problems: CHLORAMPHENICOL;
Nhat Duc Co.Ltd
Date Published : 03/24/2010
Km 234 National Rod 1a, Dinh Binh , A Mau Province, VIETNAM
16 J – – 05 Shrimp & Prawns
Date Published: 03/24/2010
Desc:Shrimp
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 03/24/2010
Desc:Shrimp
Problems: CHLORAMPHENICOL;
Phu Cuong Seafood Processing Import Export Company Limite
Date Published : 09/16/2009
454 Ly Thuong Kiet St., Ward 6 , Camau City, VIETNAM
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:8/8/2005
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:8/8/2005
Problems: CHLORAMPHENICOL;
Phu Tan Seafood Export Processing Factory
Date Published : 09/16/2009
Cai Doi Vam Town, Cai , Nuoc District , CAMAU, Camau VIETNAM
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:9/28/2004
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:9/28/2004
Problems: CHLORAMPHENICOL;
The Son Company Ltd
Date Published : 09/16/2009
1/3 Truong Son F4, Tan Binh District , Hochiminh City, VIETNAM
16 J – – 05 Shrimp & Prawns
Date Published: 09/16/2009
Notes:8/29/2002
Problems: CHLORAMPHENICOL;
16 X – – 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/16/2009
Notes:8/29/2002
Problems: CHLORAMPHENICOL;
Appendix II
Foreign exporters listed, as of November 8, 2013, on the Canadian Food Inspection Agency’s “Mandatory Inspection List” (http://www.inspection.gc.ca/active/scripts/fispoi/ial/ialfront.asp?lang=e):
- Fujian Taifeng Frozen Foodstuffs Co. Ltd. (3500/02015), China, Date Added: July 10, 2013
- Indian Ocean Co., Ltd. – Indian Ocean Seafood Factory N.V. (DL 18), Vietnam, Date Added: January 14, 2013
- Thuan Thien Producing Trading Limited Company, Vietnam, Date Added: June 27, 2013
Appendix III
2013 cases, as of November 8, 2013, of violation of Food Sanitation Law reported by Imported Foods Inspection Services (http://www.mhlw.go.jp/english/topics/importedfoods/index.html) of Japan’s Ministry of Health, Labour and Welfare:
- June 2013, Coastal Fisheries Development Corporation, Vietnam, “Ebi Tempura,” “violation of compositional standard (chloramphenicol 0.0009 ppm detection)”
- May 2013, Trong Nhan Seafood Company Limited, Vietnam, “Frozen HLSO Black Tiger Shrimp,” “violation of compositional standard (chloramphenicol 0.0006 ppm detection)”
- January 2013, Saigon Food Joint Stock Company, Vietnam, “Frozen Argentina Shrimp Hiraki,” “violation of compositional standard (chloramphenicol 0.0010 ppm detection)”
- January 2013, Ngoc Tri Seafood Joint Stock Company, Vietnam, “Frozen Shrimp Peeled Tail On(Shinken Shobu),” “violation of compositional standard (chloramphenicol 0.0013 ppm detection)”