FDA Expands Import Alert on Chloramphenicol to Cover All Crustaceans, Including Shrimp

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)”

 

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