(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
***In May 2017, the FDA analyzed frozen raw tuna products from a firm and found that they contained Hepatitis A virus. Follow up FDA screening found a second firm's raw frozen tuna contained Hepatitis A virus. ***
Hepatitis A virus is primarily transmitted by person-to-person contact through the fecal-oral route and by the consumption of contaminated food or water. Foods can be contaminated by infected workers in food production facilities/processing plants and restaurants. No known non-human sources of the virus exist. FDA believes that hepatitis A virus contaminated seafood is a result of gross insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply.
This alert EXCLUDES LACF (canned and pouched) seafood products (i.e. products with a scheduled process on file with CFSAN per 21 CFR 113).
Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food and Safety and Applied Nutrition (CFSAN) will evaluate regulatory packages on a case-by-case basis.
***Firms on the Yellow List should be detained using the HEPATITISA, INSANITARY and MFR INSAN charge code.***
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
Requests for Removal from Detention without Physical Examination under this Import Alert is a two-step process. First the firm must apply for removal from the Red List and subsequent addition to the Yellow List.
The purpose of the Yellow List is to alert the field to the names of the firms for which the FDA has agreed to allow to ship. The firms named in the Yellow List will be required to make five entries and provide laboratory results that are negative for Hepatitis A. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7.
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 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.
Per FDA's regulatory procedures manual (RPM) Chapter 9-8, "Detention without Physical Examination (DWPE)," in order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any follow-up steps taken to prevent violations in future shipments.
The application for addition to the Yellow list, and ultimately removal from DWPE, should be in English and should include the following:
1. The root cause analysis that identifies the source of the contamination.
2. Written corrective actions taken to eliminate the source of the contamination, including sanitation standard operating procedures (SSOPs)that are intended to prevent reoccurrence of contamination, the monitoring records documenting the implementation of the SSOPs, and verification procedures. SSOPs may include the following applicable items:
a. Water quality;
b. Controls for worker health and hygiene (e.g., training and monitoring for proper hand washing, monitoring of employees for
symptoms, hepatitis A vaccine);
c. Maintenance of hand washing and toilet facilities;
d. Sanitary facilities in receiving and processing;
e. Condition and cleanliness of food contact surfaces (e.g., visual inspection of gloves, outer garments and utensils);
f. Maintenance program for cleaning and sanitizing equipment;
g. Transportation practices
3. The HACCP plan and 5 days' worth of monitoring records.
Once FDA has reviewed the submitted documents and finds them to be adequate, the firm will then be added to the Yellow List. After obtaining Yellow List status, the firm may submit evidence of five consecutive shipments shown to be free of Hepatitis A. Once the firm has satisfied the requirements for removal from DWPE, the firm and/or a representative should submit a request to DIO to have the firm removed from the Yellow List, which removes the firm from DWPE.***
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forward to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
***Questions or issues involving import operations should be addressed to Division of Import Operations (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at email@example.com.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
OASIS charge code – HEPATITISA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]
OASIS charge code – INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [ADULTERATION, Section 402(a)(4)]
OASIS charge code – MFR INSAN
MULTIPLE COUNTRIES (PODS ONLY)
(16 - - - --) Fishery/Seafood ProdDesc: RAW SEAFOOD; FRESH and/or FROZEN
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)