The news that Fresh Del Monte is suing the FDA signals that, despite all the feel-good news of cooperation and communication between the industry and the agency, all is not well. You can't fight city hall, but Del Monte is devoting some of its resources and brand reputation to make a point.


From The Packer coverage:

Fresh Del Monte is suing the Food and Drug Administration to ease restrictions placed Guatemalan cantaloupe imports in the U.S. this summer.

One the largest U.S. cantaloupe importers, Del Monte Fresh, a subsidiary of Fresh Del Monte Produce Inc., stated in a news release that the FDA’s actions “threatens the viability of a major import source for cantaloupes.”

In the release, Del Monte Fresh takes on what it calls “erroneous speculation, unsupported by scientific evidence” made by the FDA and state health agency officials that the cantaloupes Del Monte imported from a Guatemalan grower were contaminated with salmonella.

The company filed the lawsuit Aug. 22, after the FDA issued an import alert on July 15.

The alert said in order to be removed 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.


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

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

* Safety of water used 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;
* Steps taken to identify and correct insanitary conditions.

Further details and examples of the types of information that can be submitted can be found in FDAs Guidance for Industry Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998) and FDAs Final Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (February 2008).

After reviewing these submissions, FDA, either solely or in conjunction with the relevant foreign governments regulatory authority, may conduct 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.  


Del Monte feels it already runs a top rated food safety program for its imported melons and states the restrictions are undeserved. From the complaint by Del Monte against FDA:

Del Monte is the largest importer of cantaloupes into the United States and is well known for selling cantaloupes of the highest quality, which are farmed, processed, transported and stored under state-of-the-art food safety controls that far exceed FDA regulatory requirements. FDA has nonetheless imposed harmful restrictions on Del Monte’s importation of cantaloupes from a major source in Guatemala, based upon an erroneous speculative assumption, unsupported by evidence, that cantaloupes previously imported from that source were contaminated with the pathogen Salmonella. The Court should issue a declaratory judgment holding that FDA’s actions restricting importation are unlawful, set aside the actions, and issue a permanent injunction prohibiting FDA from enforcing or effectuating them in the future.


In the complaint, Del Monte refers to the circumstances of their March recall, illustrating that FDA could "strong arm" even the largest companies well before the new rules of the Food Safety Modernization Act took effect:


15. Although FDA did not have an adequate factual basis for concluding that Del Monte cantaloupes imported from Asuncion Mita posed a public health risk, FDA nonetheless demanded that Del Monte must either perform a recall of such cantaloupes or suffer the consequences of an FDA consumer advisory questioning the wholesomeness of Del Monte cantaloupes. 
16. The recall demanded by FDA was not justified by the underlying evidence or by the purpose of protecting the public health. FDA lacked evidence that Del Monte cantaloupes were contaminated. Furthermore, the recall demanded by FDA related to cantaloupes that were beyond (or within a day of) their shelf life, and the retailer described above confirmed that no cantaloupes from the relevant time period remained in inventory.
17. Rather than face a general advisory regarding cantaloupes that could potentially affect the entire cantaloupe market, Del Monte acceded to FDA’s demands and issued a limited recall on March 22, 2011.


Here is the full complaint.