Import Alert 16-133

DETENTION WITHOUT PHYSICAL EXAMINATION OF TUNA FROM MOON FISHERY INDIA PVT LTD

In early March of 2012, FDA began communicating with CDC about a cluster of Salmonella Bareilly infections that indications suggested might be linked to the ingestion of seafood. Interviews of cases by state and local health department officials revealed that many patients reported eating sushi prior to onset of illness, and that spicy tuna was commonly an ingredient in ingested meals.

As of April 12, 2012, a total of 129 persons infected with the outbreak strain of Salmonella Bareilly had been reported from 20 states and the District of Columbia. Twelve ill persons have been hospitalized, and no deaths have been reported.

On April 13, 2012, it was confirmed from trace back studies of tuna consumed by persons who ate at four cluster-associated restaurants revealed that, all four restaurants, tuna from a single source ¿ Moon Fishery India Pvt Ltd, located in Kerala state, India ¿ had been served to persons who subsequently became ill..

Circumstantial and epidemiologic factors are consistent with FDA findings that imported tuna from Moon Fishery India Pvt Ltd has served as the vehicle of infection. FDA conclude that contamination with Salmonella Bareilly is likely due to inadequate sanitary controls after harvest on the fishing vessels, during processing or packaging. Sources of contamination may include water contamination, and/or poor hygienic practices of workers that process the product, pests in packing facilities, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product.

Districts may detain, without physical examination, all raw fresh and frozen tuna offered for importation that appear to originate from the firms listed on the attachment.

If a firm believes that its product should not be subject to detention under this import alert, the firm should forward information supporting its position to FDA at the following address:

Food and Drug Administration
Division of Import Operations & Policy
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

DIOP will then forward the information to CFSAN for review.

In order to remove a firm from detention without physical examination, the following should be provided to FDA:

1. Information demonstrating that the conditions or practices that gave rise to the appearance of a violation have been resolved. Such documentation from an inspection, may include documentation from an appropriate third-party illustrating that an inspection of the processor was conducted and that the seafood was processed in accordance with FDA's Seafood HACCP regulations, 21 CFR part 123,

and

2. Evidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act.

To assess the adequacy of the firm¿s processing and transportation practices, FDA personnel should review information submitted, describing the firm¿s practices in the following areas:

* Safety of water used in washing, rinsing, packing, cooling and ice making;
* Worker health and hygiene;
* Maintenance program for cleaning, sanitizing equipment;
* Conditions aboard fishing vessel;
* Transportation;
* Steps taken to identify and correct insanitary conditions.
* Seafood HACCP plan
* Test results of any products sampled during the course of the inspection, as well as environmental samples.

After reviewing these submissions, FDA, either solely or in conjunction with the relevant foreign government¿s regulatory authority, may conduct on-site inspections of the processing areas to audit the validity of the information submitted to FDA.

Questions regarding scheduling an inspection may be directed to DIOP at 301-796-0356

Questions related to submission of may be directed to CFSAN, Office of Compliance/Food adulteration Assessment Branch (HFS-606) at (240) 402-1620.

PRODUCT: Tuna, fresh, frozen

PRODUCT CODE: 16A[][]45

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that such article appears to contain Salmonella, a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]."
OASIS CHARGE CODE: SALMONELLA

and

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]."
OASIS CHARGE CODE: INSANITARY

and

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been manufactured, processed, or packed under insanitary conditions [Section 801(a)(1)]."
OASIS CHARGE CODE: MFR INSAN