Among those of us who have studied the FDA and its actions in relation to food safety, one thing is extraordinarily clear: Whatever the underlying goals of the food safety laws, acknowledging the mostly benign intentions of the top FDA officials in their day-to-day workings at the FDA, the FDA often comes across as a bully and, once having acted, FDA executives feel the enormous priority to avoid any admission of error, regardless of the costs or consequences to others.
To this day, for example, although the Salmonella Saintpaul investigation is long over and, clearly, tomatoes were not the cause — the FDA has never clearly admitted its error or apologized to the innocent tomato growers whose business it ruined. Nor has the FDA petitioned Congreess to provide financial relief for those whose businesses were destroyed or damaged by the FDA’s actions.
Yet as unfair as the FDA can be with domestic producers, it is absolutely arbitrary when it comes to foreign producers. We highlighted the way it acted with caprice toward a Honduran melon producer here and discussed the way the FDA abused import alerts with an attorney named Christine M. Humphrey, Esq. At the time, she was with Fuerst, Humphrey, Ittleman, but now is with C. Humphrey and Associates. You can read the piece below:
Fix Suggested For FDA’s Vigilante System Of Banning Product Through Import Alerts
We also discussed how difficult, indeed almost impossible, it is for the produce industry to get recompense in a discussion with Richard Epstein, a prominent law professor and author who has been named one of the 20 most influential and important legal thinkers of our time:
With FDA/CDC Protected By Sovereign Immunity, Compensation For Losses Looks Bleak Says Professor Richard Epstein
The problem is obvious: There are no ready checks on FDA’s power. An FDA official shows up and bans imports from a farm or demands a recall and, without going to court, there is no independent body one can ask to review the correctness of FDA’s actions. The FDA is judge, jury, prosecutor and executioner all rolled into one.
Generally produce firms will do anything, no matter how ridiculous, to get the FDA to cooperate. So if the FDA sees a telephone wire above a farm and demands that it be moved lest a bird sit on it and defecate on the field below, the farm spends the money and removes it, despite the fact that birds don’t require a wire to do their business and despite the fact that the farm next door is not required to make the change.
The absurdity comes about because once the FDA has decided to impose an import alert, it generally won’t lift it until “corrective action” is taken. Yet, it is often the case that even if the FDA is correct and that farm was the source of a pathogen on produce — and very often the FDA’s evidence for these claims is scanty — thorough inspection of the farm provides not a clue as to what might have gone wrong. As such, there is no known “corrective action” to take.
But the FDA can’t accept that and so demands lots of things that it doesn’t believe in enough to make a policy — just as there is no policy that all farms must not have telephone wires above them. This whole process can easily cause a grower to miss an entire season. After all, who is going to plant melons in Central America if there is an “import alert” blocking them from shipping to the US?
Going to court is generally not an option. First, doing it right with lawyers and expert witnesses is enormously expensive, and produce is typically a low value commodity. Second, going to court takes time and the one thing we don’t have with produce is time. If the product exists, it needs to be sold, and if we are speaking of future business, it needs to be planted – now. Third, the FDA has such enormous powers and is free to exercise them in such an arbitrary manner that those being regulated are afraid to stand up to the FDA because even if they win on the issue at hand, they fear the vengeance of FDA officials in the future.
Of course, what tends to stop a bully is the shock he experiences when someone stands up to him.
The produce trade associations have generally been taciturn when it comes to the FDA. They also have to work with the FDA so are unwilling to call them out even when they know they are incorrect or abusive.
With individual firms afraid to speak up and the trade associations attempting to avoid conflict, we have a situation in which businesspeople become supplicants before government, pleading for favors rather than asserting their rights. It is a situation that debases democracy and republican government.
As such, the produce industry now owes a debt of gratitude to Del Monte Fresh as it has announced that it is not going to simply sit around and be abused. But is going to stand up and fight:
Del Monte Fresh Produce N.A., Inc. Files Lawsuit Against FDA in U.S. District Court
Company Seeks Reversal of Agency Action Restricting Import of Cantaloupe
CORAL GABLES, Fla., Aug 24, 2011 – Del Monte Fresh Produce, N.A., Inc., a subsidiary of Fresh Del Monte Produce Inc. (NYSE:FDP), filed suit on Monday, August 22, 2011 against the Food and Drug Administration (FDA) in U.S. District Court for the District of Maryland to seek an injunction that would lift an FDA rule restricting the importation of wholesome fresh cantaloupes into the United States.
Del Monte Fresh is one the largest importers of cantaloupes into the U.S. and is well known for selling fruit of the highest quality. The melons are farmed, processed, transported, and stored under state-of-the-art food safety controls that far exceed FDA regulatory requirements.
Del Monte Fresh’s claims are based on the FDA’s (and several other state health agency officials’) erroneous speculation, unsupported by scientific evidence, that cantaloupes previously imported by Del Monte Fresh from a Guatemalan farm and packing facility were contaminated with the pathogen Salmonella. In fact, neither the FDA nor any state health agency in the U.S. has offered evidence or data to support the FDA action.
”Del Monte Fresh Produce places the highest priority on food safety and protecting customers. We require all of our suppliers to comply with all FDA-recommended food safety procedures, including the FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, as well as the FDA’s Sanitary Standard Operating Procedures. The farm and packing facility at issue in this case was in full compliance with these food safety procedures. The restrictions imposed by the FDA on Del Monte Fresh Produce’s ability to import cantaloupes are unnecessary and not supported by the facts,” said Dennis Christou, Vice President Marketing, N.A. of Del Monte Fresh.
The FDA’s actions adversely affect Del Monte Fresh’s ability to receive perishable fresh produce for sale to its customers in the U.S., as the import alert threatens the viability of a major import source for cantaloupes. Since significant resources and commitments must be finalized immediately to ensure Guatemalan cantaloupes will be ready for harvest in the near future, Del Monte Fresh is seeking immediate injunctive relief from the court.
The lawsuit makes for fantastic reading and you can read the whole complaint here.
First, the complaint points out how flimsy the evidence is that Del Monte Fresh even was involved with this matter:
… these officials reached this conclusion without a sufficient factual basis to support the conclusion. Among other things, on information and belief, these officials reached this conclusion without ever testing any cantaloupes to determine whether they were contaminated with Salmonella.
FDA later concluded that cantaloupes imported by Del Monte from PAO’s farm in Asuncion Mita, Guatemala (and allegedly contaminated with Salmonella) were the likely source of the illnesses described above. This conclusion was not rationally supported by the evidence available to FDA. FDA also did not adequately take into account evidence that did not support that conclusion. In addition, FDA’s conclusion was a clear error of judgment. Among other things:
All of the microbiological evidence available to FDA supports the conclusion that cantaloupes from PAO’s farm in Asuncion Mita were not contaminated with Salmonella….
All of the information collected by FDA in a recent inspection of PAO supports the conclusion that cantaloupes from PAO’s farm in Asuncion Mita were not contaminated with Salmonella.
…In November 2010, shortly before the illnesses described above occurred, FDA inspected PAO’s farm located in San Jorge, Guatemala. FDA did not issue a form FDA-483 at the conclusion of the inspection. A form FDA-483 is a list of inspectional â€• observations.
By deciding not to issue a form FDA-483, FDA acknowledged that it did not identify any objectionable conditions significant enough to provide to the company in writing. By deciding not to issue a form FDA-483, FDA confirmed that PAO’s food safety procedures at the San Jorge farm are in substantial compliance with FDA regulatory requirements pertaining to food safety. The same conclusion applies to PAO’s Asuncion Mita farm, because the Asuncion Mita farm is subject to the same PAO food safety procedures as the San Jorge farm, and the same PAO quality assurance team monitors compliance with food safety requirements and procedures at both the San Jorge and Asuncion Mita farms.
FDA has not adequately accounted for evidence indicating that the illnesses described above were not caused by cantaloupes at all. For example, one of the patients described above denied consuming cantaloupes before becoming ill.
FDA has not adequately accounted for the possibility that any allegedly contaminated cantaloupes came from sources other than Del Monte. For example, on information and belief, the retailer that FDA alleged had sold contaminated cantaloupes to most of the patients described above had three other suppliers of cantaloupes in addition to Del Monte during the relevant time period. On information and belief, FDA never investigated the three other suppliers to determine whether they were a potential source of Salmonella contamination. In addition, one of the patients described above consumed cut cantaloupe reportedly purchased from a retailer that is not supplied by either PAO or Del Monte. Another patient reportedly consumed cantaloupe imported from Honduras, not Guatemala, that could not possibly have come from PAO or Del Monte, because neither company harvests cantaloupes in Honduras.
FDA has not adequately accounted for the possibility that any alleged contamination of Del Monte cantaloupes occurred after the cantaloupes left the custody of Del Monte in the domestic commercial supply chain…
Second, the complaint points out that Del Monte Fresh was pressured by the FDA into declaring a recall:
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.
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.
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.
Third, Del Monte Fresh tried to reassure the FDA:
Del Monte retained third party experts to evaluate PAO’s compliance with Good Agricultural Practices in general, and in the exact fields where the allegedly contaminated cantaloupes were harvested, and in its packinghouse handling process. The experts’ audit, conducted from April 6-14, 2011, included a review of PAO’s compliance with Good Manufacturing Practices, Standard Sanitary Operating Procedures, Food Safety Program and Hazard Analysis and Critical Control Points program.
The audit confirmed that PAO’s farm and packinghouse operations meet and/or exceed current guidelines required to maintain a high level of food safety and regulatory compliance such that only wholesome food is shipped.
Fourth, Del Monte Fresh even did a test-and-hold program, although as we discussed recently here and in an interview here, this is very expensive and not likely the best way to achieve food safety:
In an abundance of caution, Del Monte requested the third-party experts to establish a rigorous pre-importation test-and-hold program for lots of cantaloupes shipped from the Asuncion Mita farm from the time of the limited recall until the end of the growing season. Under the program, samples were taken from packed product before it left the PAO packinghouse and were tested for the presence of Salmonella by an ISO-certified laboratory in Guatemala City. The third party experts concluded that all such samples tested â€• negative for any Salmonella species.
Fifth, when FDA imposed its “Import Alert,” it had no reasonable basis to do so:
FDA’s imposition of Import Alert #22-03 was based entirely on the unsupported alleged association between Asuncion Mita cantaloupes and the illnesses from Salmonella described above. FDA did not have, and never has had, evidence that cantaloupes from Asuncion Mita caused the Salmonella illnesses described above. In issuing Import Alert #22-03, FDA did not have, and never has had, any evidence of either â€• spot contamination or widespread or systemic contamination of Asuncion Mita cantaloupes.
Import Alert #22-03 expressly states FDA’s conclusion that the source of the contamination is likely one or more of the following: irrigation of fields with water contaminated with sewage; processing produce with Salmonella-contaminated water; poor hygienic practices of workers that harvest and pack the produce; animals in close proximity to product or water sources; and/or lack of adequate cleaning and sanitizing of equipment that comes in contact with the product.
On information and belief, FDA has no evidence whatsoever that PAO’s Asuncion Mita operation has irrigated fields with water contaminated with sewage; processed produce with Salmonella-contaminated water; used workers for harvesting and packaging that have poor hygienic practices; had animals in close proximity to product or water sources; and/or lacked adequate cleaning and sanitizing equipment that comes in contact with product. To the contrary, the evidence available to FDA from its own microbiological testing of Asuncion Mita cantaloupes, from its recent inspection of PAO’s farm in San Jorge, and otherwise, wholly undermines any assertion that such practices have occurred or are occurring.
Sixth, after explaining how damaging an import alert can be, the complaint states the real point — that the agency has no basis for its actions:
FDA’s imposition of Import Alert #22-03 is an arbitrary and capricious final agency action within the meaning of 5 U.S.C. § 706(2)(A). Among other things, this action (1) is not rationally connected to the evidence before FDA; (2) is based upon a clear error of judgment; (3) has not adequately taken into account evidence that does not support Detention Without Physical Examination.
FDA’s imposition of Import Alert #22-03 also is an arbitrary and capricious final agency action because it is not justified by the factual conclusions that FDA has relied upon as the justification for the action. Among other things, FDA’s conclusions in Import Alert #22-03 as to the likely source of alleged cantaloupe contamination (described in paragraph 23 above) have no evidence supporting them (as explained in paragraph 24 above).
Seventh, the complaint points out that the law does not give FDA authority to do what it is doing. This is a long and technical section. Part of the issue is that the law only gives authority to FDA under certain conditions. If it knows of food “manufactured, processed, or packed under insanitary conditions” or if the food is “adulterated” because it has been “prepared, packed, or held under insanitary conditions whereby . . . it may have been rendered injurious to health” — but the FDA has no particular basis for believing that Del Monte’s cantaloupes meet any of these criteria. In fact, from everything we know about food safety the opposite is true. These are exemplary farms and packing houses.
Eighth, the complaint points out that FDA abuses its powers to evade its legal responsibilities. Legally the FDA is required to follow what is called “notice and comment procedures,” but it does not do so. It declares that Alerts are actually just guidance to field offices and those don’t require evaluation through a notice-and-comments procedure. Of course, these are not “guidance” at all. They are firm rules that require the proper procedure be followed.
Hopefully Del Monte’s attorney will make a motion to seek outside counsel to bring in Christine M. Humphry, who we mentioned above, as a specialist on cases of this type. She wrote the key Law Review article on this matter — The Food and Drug Administration’s Import Alerts Appear to Be “Misbranded” — and, as a former FDA Investigator/Compliance officer, she has unique insights:
This article suggests, however, that Alerts—labeled as “guidance”—do not provide fair notice. The aggregate effect is an administrative scheme that undermines principles of uniform enforcement, and moreover, fundamental fairness and procedural due process, which are the hallmarks of the Administrative Procedure Act’s (APA’s) notice-and-comment procedures.
The situation is a terrible one, from a public health standpoint, the FDA, by giving no weight to the quality of the operation, reduces incentives to invest in food safety programs. From a public policy standpoint, the arbitrary use of power is bound to be abused.
The FDA’s response to all this is basically that though it has no hard evidence, it has epidemiology that indicates that Del Monte Fresh’s production was implicated. Just as criminals can be convicted on circumstantial evidence, so, sometimes, food safety decisions are made based on epidemiology. Fair enough, but epidemiology is used by the FDA as a kind of magic incantation as if just saying the word proves the case. Yet the prominent epidemiologist of our time had no problem standing up and attacking the efforts of epidemeologists during the Salmonella Saintpaul outbreak:
Dr. Michael Osterholm, Esteemed Authority On Public Health, Speaks Frankly About The FDA, The CDC And The Incompetent Management of the Salmonella Saintpaul Tomato Outbreak Investigation
In general, just as the availability of DNA tests is going to move jurors to greater skepticism in reviewing cases with purely circumstantial evidence, allegations of foodborne illness sourcing that can’t be verified via testing will increasingly be judged with skepticism.
At very least, the FDA should be required to provide contemporaneous transparency so outside epidemiologists can critique its work and point out errors. There need to be PACA like independent review boards that can assess epidemiological claims. Most of all the expectation that in some magic way every cause will be found and so corrective action can be taken needs to be abandoned.
Hopefully Del Monte Fresh’s actions will get a court to put reins on the agency. The industry owes the company a hat tip just for being willing to try.