Guidance From FDA For Mexican Cantaloupes

Member Information Alert
Date: October 30,2002
Contact: Dr. Donna Garren/Hilary Hausman, 703/836-3410

Earlier this week, the FDA issued an import alert for cantaloupes originating from Mexico. This import alert is not a result of a current outbreak but rather a result of incidents from previous years. Cantaloupes that were in the supply chain prior to this notification are not affected.

After discussions with several FDA officials, they provided the following guidance:

Districts may detain, without physical examination, all raw fresh and raw fresh refrigerated cantaloupes offered for importation from the country of Mexico for the reasons indicated.

If a firm, grower, processor, packer, or importer believes that their products should not be subject to this import alert, they should forward information supporting their position to FDA's DIOP (HFC-170) for review by the Office of Compliance (HFS-606). In order to assess the adequacy of the firm's agricultural, processing, and transportation practices, FDA personnel should review information submitted 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;

If applicable, steps taken to identify and correct insanitary conditions which are indicated by positive analytical results for Salmonella in the firm's product, or as a result of an epidemiological traceback investigation

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, 1996).

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. Qualifications for these firms should be included in the written request to FDA.

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)(3) of the Act, FDA considers submission of analytical results showing the absence of Salmonella 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.

According to both the FDA and Mexican officials, both governments are developing a long term strategy for a pre-certification process that will assure compliance and will be managed by the Mexican federal government.

For the complete FDA consumer and media advisory, please visit http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01167.html

Please be advised that any additional information we receive from the FDA will be forwarded as soon as possible.

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