IA #25-20, 11/25/03, IMPORT ALERT #25-20, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF GREEN ONIONS (SCALLIONS) FROM SPECIFIC FIRMS IN MEXICO"
(***) indicates changes/revisions
TYPE OF
ALERT: Detention without Physical Examination (DWPE)
(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)
PRODUCT: Green onion (scallions), fresh, raw
PRODUCT
CODE: 25J [ ][] 04 Green Onion (scallion)
25L [] [] 04 Green onion dried or paste
25J [] [] 99 General code - Root & Tuber Vegetable, N.E.C.
PROBLEM: Hepatitis A Virus
PAF: MIC
PAC FOR COLL: 03F098
COUNTRY: MEXICO (MX)
MANUFACTURER/ SHIPPERS FEI: SEE ATTACHMENT
CHARGE: "The article is subject to refusal of admission pursuant to Section
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)]."
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)]."
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: HEPATITIS A VIRUS (HAV)
CODE: INSANITARY
MFR INSAN
RECOMMENDING OFFICE: CFSAN, Office of Compliance, Imports Branch (HFS-606)
REASON FOR ALERT: 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.
GUIDANCE: Districts may detain, without physical examination, all raw fresh
and raw fresh refrigerated green onions (scallions) from the firms identified
in the Attachment 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/Imports 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/Imports Branch (HFS-
606) at (301) 436-2413.
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.
PRIORITIZATION GUIDANCE: I
FOI: no purging necessary
KEYWORDS: Hepatitis A Virus, pathogens, illness, produce, viral
contamination
PREPARED BY: Division Import Operations and Policy, HFC-170
Dave Krawetz, 301-594-3872
DATE LOADED INTO FIARS: November 25, 2003
ATTACHMENT LIST OF FIRMS/PRODUCTS THAT ARE ON DETENTION WITHOUT PHYSICAL
EXAMINATION 10/28/04
Firm Name and Address: Product/codes:
Dos M Sales De Mexico 25J [ ][] 04, 25L [] [] 04, 25J [] [] 99,
Ave. Cairo 315 Villa Fontana
Mexicali, B.C MX
FEI: 3002565013
a.k.a.
2 M Sale De Mexico, Sa De Cv 25J [ ][] 04, 25L [] [] 04, 25J [] [] 99,
Av Durango Y Benjamin Hill #205
San Luis Rc MX
FEI: 3002397969
Agricola La Laguna, S.A. De C.V. 25J [ ][] 04, 25L [] [] 04, 25J [] [] 99,
(a.k.a. Sun Fresh)
Rancho La Laguna S/N. El Real
Ensenanda, B. California MX
FEI: 3002824398
Tecnoagro Intenrnacional, S.A. De C.V. 25J [ ][ ] 04, 25L [] [] 04,
Km. 18 Carret. A Riito, Ejido Islita 25J [ ] [ ]99
San Luis Rio Colorado MX
FEI: 3003962780
a.k.a
Tecno Agro Internacional S.A 25J [ ][] 04, 25L [] [] 04, 25J [] [] 99,
Av. Lazaro Cardenas #81
Ensenada MX
FEI: 3004060704