"Detention Without Physical Examination of Green Onions (Scallions) from Specific Firms in Mexico"

In September 2003, there were two outbreaks of Hepatitis A Virus (HAV) in Tennessee and Georgia. Subsequent investigations and epidemiological data implicated fresh green onions (scallions) from three firms in Mexico as the cause of the outbreaks. There were 77 cases reported in Tennessee, all of which were associated with a restaurant in TN. In the Georgia outbreak, 25 of the 200+ cases were associated with restaurants. FDA's investigations implicated Mexican green onions (scallions) from sources in Mexico.

HAV is excreted in feces of infected people and can produce clinical disease when susceptible individuals consume contaminated water or foods. HAV is primarily transmitted by person-to-person contact through fecal contamination, but common-source epidemics from contaminated food and water also occur. Poor sanitation and crowding facilitate transmission. Contamination of foods by infected workers in food production facilities/processing plants and restaurants is common. No known non-human sources of the virus exist. This fact, in conjunction with the epidemiological evidence, leads FDA to believe,that the implicated green onions were contaminated as a result of insanitary
conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply.

FDA believes that green onions (scallions) imported from Mexico appear to be adulterated under Section 801(a)(3) of the Federal Food Drug and Cosmetic Act (Act) because they appear (1) to contain Hepatitis A Virus, an added poisonous or deleterious substance that may render food injurious to health within the meaning of section 402(a)(1) of the Act and (2) to have been prepared, packed,or held under insanitary conditions whereby they may have been rendered injurious to health within the meaning of Section 402(a)(4) of the Act. In addition, the green onions (scallions) violate section 801(a)(1) of the Act in
that they appear to have been manufactured, processed, or packed under
insanitary conditions.

Districts may detain, without physical examination, all raw fresh
and raw fresh refrigerated green onions (scallions) from the firms identified in the Red List to this Import Alert.

If a firm, grower, processor, packer, or importer believes that their product should not be recommended for detention under this import alert, they should forward information supporting their position to FDA at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance/Product Adulteration Branch(HFS-606)
5100 Paint Branch Parkway
College Park, MD 20740

In order to assess the adequacy of the firm's agricultural, processing, and transportation practices, FDA personnel should review submitted information describing the firm's practices in the following areas:
* Water quality in irrigation, packing, and cooling;
* Manure use and biosolids, animal management;
* Worker health and hygiene;
* Sanitary facilities in field and packing house, disposal of sewage and Silage;
* Maintenance program for cleaning, sanitizing equipment;
* Field and packing facility sanitation;
* Transportation;

Further details and examples of the types of information that can be submitted can be found in FDA's draft Good Agricultural Practices (FR 63 FR 18029, April 13, 1998) *** AND FDA's Guide to Minimize Microbial Food Safety Hazards For Fresh Fruits and Vegetables (63 FR 58055, October 29, 1998; www.foodsafety.gov/~dms/prodguid.html) ***

After reviewing these submissions, FDA, either solely or in conjunction with the relevant Mexican regulatory authority, may conduct a limited number of on-site inspections of the growing/processing areas to audit the validity of the information submitted to FDA. FDA intends to give priority in scheduling these inspections to firms or growers who provide certification from an independent institution or third party that has expertise in agricultural and transportation processes.

Questions may be directed to CFSAN, Office of Compliance/Product Adulteration Branch (HFS-606).

NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of Hepatitis A Virus to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801 (a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.

Green onion (scallions), fresh, raw

"The article is subject to refusal of admission pursuant to on 801(a)(3) in that such article appears to contain Hepatitis A Virus, a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]."

OASIS charge code - HEPATITISA

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".

OASIS charge code - MFR INSAN