As the result of the release of the FDA environmental assessment at Jensen Farms, the roles of all food safety persons involved at Jensen Farms-Frontera have rightfully come under fire. Once again the nature of industry-led food safety regulation itself (food safety auditing) is in question.
That all involved maintain some degree of responsibility for this disaster is without question. When a disaster like this occurs, one must ask who is responsible, but also why did it occur and how can it be prevented in the future.
The produce industry is unregulated and has been since the founding of this country, and this is the primary problem. In the recent past, we have become painfully aware of the inadequacies of our industry-led prevention efforts at the farm level. In defense of the effort, while much has been done, it has been a short time to change the nature of agriculture. This is what we are doing by implementing food safety strategies in open air and on-farm environments. We must also change the culture; animals on farms, for example, have been a given for centuries.
Food safety auditors executing a buyer-driven auditing model rely upon the certification body to develop and manage the standard that guides their work in the field. The standard is not a public health law and it is not developed like one. The auditor has no legal authority to demand records, embargo products, or close an operation, for example.
Enforcement, if you will, has been in the hands of the “buyers.” They rely on third-party audits, their own second-party audits, letters of guarantee and the like, before make buying decisions. Buying decisions should take into account food safety, but supply and demand pressures might induce buyers to purchase from sources without a clear safety margin. However wrong this is, there is nothing illegal about this practice.
Auditors currently are not required to inform FDA of violations, but auditors are currently required to know what regulatory violations have been cited in the records of the firm, and if they were corrected. Auditors are also expected to follow the guidelines of the audit and make an accurate assessment of findings. When this is not done we must ask why.
So there is a connection between the two independent systems of food safety “regulation,” but a relationship that is way underutilized.
Auditors conduct prearranged audits to evaluate the conditions of the environment, equipment, water supply, personnel, waste removal, use of chemicals, vector control, general sanitation, equipment hygiene, and structure maintenance, within a sometimes narrow scope of the audit.
Regulators should be approving plants and operations in advance, then making frequent unannounced visits to determine compliance with laws and rules. They also have free range to demand any required document and inspect any licensed area. While both touch on the same items, the perspectives and powers are vastly different. The legal process should occur in cases where violations are not corrected or immediate threat to the public is found, and buyers should not purchase from unsafe sources.
Auditors cannot perform these vital public health functions, nor can they directly affect buying decisions.
Generally, FDA guidance and the available research form the basis for the audit criteria. However, issues like severity can be difficult to interpret. For example, in cantaloupes the commodity has not had the type of industry oversight we have in leafy greens or tomatoes (under market orders). But FDA has provided guidance to the melon industry. We should mention this reference below:
— Using single pass (or one use) cooling water of sufficient quality for this intended purpose also may be used to cool product.
This is the source of info that indicates single pass water of sufficient quality may be used for washing melons. There is no mention of antimicrobial in this application. For dump tank or flume water, or where direct melon-to-melon contact occurs in common water, then treatment is indicated. Standards vary greatly as to disinfection of water, and for sanitizing various fruits and vegetables.
The risk assessments are still developing (and so are the politics involved with any industry-led effort.) It is telling that, according to “commodity thinking,” cantaloupes fall into the class of fruits and vegetables with “inedible peels.” This narrow definition ignores the other routes of disease transmission with this product. Microbial testing of products and the production environments is not a given. This is telling because in other Listeria-susceptible products FDA and USDA demand stringent testing programs for the environment.
Water used in packing operations is required by the third parties to be potable. FDA has not published specifics about how to determine potability in a packinghouse environment, the references simply being for the use of potable water at the start of a washing process. Potability has come to mean that coliform bacteria are not present in a 100 ml sample. There are no guidelines for chemical parameters for safety in the potable supply and no requirements for the wells themselves to be treated or permitted before construction. No FDA requirement I know of demands that the local health departments permit, inspect, and require a certified operator to maintain the water quality.
At Jensen Farms, wash water for cantaloupes was apparently not reused, being simply a single pass wash of cantaloupe without treatment. There is nothing prohibiting washing cantaloupes or any produce in this fashion in the standard as long as the source is potable. This is room for improvement in the third-party standard, but until the industry as a whole agrees on water treatment standards for these melons it is unclear how to develop them. This is now apparently a glaring deficiency, and just one amongst myriad things not addressed in food safety at the packinghouse level by FDA.
In light of these problems in our food safety systems, auditors and auditing companies have stood in the gap for regulators. I appreciate FDA and its remarks concerning the training of auditors and any classes they could offer would be much appreciated. To date, however, I know of know such training program for industry auditors sponsored by the FDA that is available today. One day that might change.
We also have to thank the FDA for such a well-developed theory on causation and it is perfectly clear that the focus should be on the packing environment.
Problems that existed in this plant in this situation are accurately described by FDA in its report. The evidence is clear for the propagation and spread of Listeria monocytogenes through water and surfaces, and “improper cooling” of cantaloupe. Pre-cooling to remove field heat as a route of causation makes perfect sense, but pre-cooling is by no means a standard practice on farms or packinghouses in general, as pointed out by FDA in its guidance.
The nature of equipment in packinghouses is subject to contamination and often hard to clean; moving heavy crates of products will deteriorate floors; draining is often a problem especially where washing flumes and spray systems are used. Some structures and waste disposal systems are better developed than others for this type of “dirty” packing work; however, there are no standards for construction of a packinghouse.
Currently, there are no regulations for the construction and maintenance of packing equipment; its design, layout or even fundamental function have no legal basis. Regulatory agencies normally have the functions of approving the designs, equipment and plumbing schedules, lighting, finish of walls and floors in a plant. Auditors rate these items according to the dictates of the standard within the scop
e of the audit. Of course, FDA has the authority over such, and it would be best to have regulations of these items, but FDA has not exercised that authority and has only written guidance for general requirements. I appreciate what FDA has done in ferreting out the causation at Jensen/ Frontera, but it would have been much better for them to have published packinghouse rules, and been there before the outbreak to enforce the requirements they address as violations now.
Therefore, in light of these ongoing and serious gaps in food safety, the industry itself has required what it finds to be the best practices to protect itself to the extent it can. That these industry requirements are suited to the needs of the buyer is self-evident and expected. More importantly, things need to change as we understand risks better; but what a tragic way to learn.
It’s sad that the farmer in this case did not recognize the difference between his potato line and a “cantaloupe line,” nor the distinction between a potentially hazardous product like cantaloupes and a non-potentially hazardous raw potato. In crops like potatoes, bulb onions, carrots, beets, there is dirt, the distinctions between risks of different crops do not generally drive standards. However, with melons the risks should have been identified, and the best practices possible followed, and they were not.
In a risk assessment we develop such preventive measures for a variety of crop types and information like this often comes out if properly done. But then, HACCP is not “required” in produce; but training in risk assessments should be mandatory for operators of high risk facilities and especially for auditors.
About the future of third-party audits, I think we need the FDA to be conducting their own risk assessments and allow us third parties to simply be the eyes and ears of industry, and not the enforcers of public health protection in this nation.
This is not the role of the third-party auditor.
“The Role of the Third Party Food Safety Auditor” was first posted on Roy Costa’s Food Safety & Environmental Health Blog on Oct. 22, 2011. Reposted with permission.© Food Safety News