Food Safety and Environmental Health Blog : Disease Prevention, Public Health, Sanitation Information & Analysis : Environ Health Associates

We are now seeing huge gaps in the food safety net.  We also see the effect of the serious pathogens like E coli that have become entrenched in our food animals, thus in our food supply, and in our environment. The failure of agriculture to control E. coli has contaminated the entire food supply, our water and soil.

These events will continue and escalate due to our inability to create a nationwide food safety system form farm to fork and the propensity of these pathogens to proliferate. Glaring deficiencies exist; most notably, flaws in basic sanitation and related practices found at the farm, in restaurants, and in the transportation sector are going without effective controls. These correctable conditions if left uncorrected allow for the persistence of deadly infectious agents in food.

While we  as an industry concentrate our prevention efforts in the supply chain, remember that not addressing the starting and ending points of this chain thwarts all other purposes.

A comprehensive approach to the problem must involve a strong response by FDA to both on farm and consumer safety.  Without adequate resources, FDA cannot do this job. Without industry support for proper funding the Food Safety Modernization Act will fail. This Act crafted by industry working alongside government addresses concerns in the food supply in the most comprehensive approach yet attempted,

A double standard is evident in the lack of industry support for FDA and FSMA. This is clearly seen in a letter to congress from the American Meat Institute and its signatories.

As long as powerful political interests put political power and influence over public health, food safety in this country will continue to deteriorate. The effect on industry has already been devastating for certain groups, especially for growers of tomatoes, spinach, peanuts; and now the entire melon industry is tainted with the problem of Listeria monocytogenes in cantaloupes.

The many millions of dollars defending lawsuits and untold millions lost in sales, as well as the loss of confidence of the American consumer, and the huge burden for those with resulting health care costs are compelling reasons for industry to support FDA.

Industry paying its fair share is something we should expect. Just "not wanting to pay" to ensure that there is a strong regulatory framework for food safety is not acceptable.

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 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 the 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, washwater 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 a myriad of 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 scope 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.

Its 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.

Part 1

Outbreaks in fresh produce, while tragic for victims, nevertheless can have a positive outcome if we can learn how to better prevent them, or at least reduce their occurrence. This four part series will discuss the current produce outbreaks in cantaloupes, cucumbers, celery and strawberries and analyze the information that is known, with the intention of improving our food safety systems.

Recent breakthrough events

While the fresh produce industry in the US continues its food safety efforts, pathogens have recently broken through our safety net in diverse products such as cantaloupes, cucumbers, celery, and strawberries. These events have highlighted our immediate need to strengthen food safety systems in the entire fresh produce industry.

The fresh produce industry utilizes Good Agricultural Practices (GAP), Current Good Manufacturing Practices (cGMP), and Hazard Analysis Critical Control Point (HACCP) systems based primarily on guidance from The US Food and Drug Administration (FDA). Some producers of high risk products bolster these efforts with commodity specific guidelines developed by industry. Firms also utilize microbial sampling programs for water, environments and products, and implement traceability programs. Various agencies may have jurisdiction at the produce/processor level of the fresh produce industry, but most of the growing, packing and transportation of produce remains without consistent government oversight. The Food Safety Modernization Act gives FDA broad new authority to tighten regulations in the fresh produce industry, but the agency has not yet effectively exercised these new powers.

Dynamic Industry Based Food Safety Programs

In the absence of mandatory food safety rules in fresh produce, the industry has developed its own voluntary program for produce safety, including its own standards. These programs consist of science-based standards, policies and procedures, training, sampling, and the maintenance of records to support GAP, GMP and HACCP. The major buyers of fresh produce (retailers such as Costco, Wal-Mart, Publix, Kroger, among many others), insist upon the verification of these safety measures using ongoing third party, second party and self-audits. Government agencies, producers and buyers randomly test products for pathogens, and the industry conducts voluntary product recalls when pathogens are found.

These programs should not be static; preventive measures taken by the industry should change and adapt as we learn more about how pathogens contaminate, proliferate and survive in the chain of production from the farm to the consumer.

While it is not possible to know the route of transmission in every situation, we should still analyze foodborne illness outbreaks. What we do know about pathogens can be just as important as what we do not know. Achieving the ideal of a farm to fork food safety net requires a dynamic response from the entire supply chain to the problem of contamination.

Salmonella Outbreak in Cantaloupe

On March 22, 2011 the Del Monte Company issued a limited voluntary recall of cantaloupes from its Asunción Mita, Guatemala farm, saying they have the potential to be contaminated with Salmonella Panama. Over the course of the ensuing outbreak, authorities identified 20 victims in 10 states linked to this farm by epidemiological investigative techniques.

In this outbreak, as in many others, investigators failed to isolate the causative agent from a suspect melon. This prompted two law suits, one against the FDA, and another against a state epidemiologist. Del Monte asserts that the epidemiological approach used to associate cases with vehicles was flawed; while investigators contend that such a rare serotype could not be caused by anything other than exposure to a common vehicle. FDA points out that almost all victims of illness purchased cantaloupe from stores supplied by the Del Monte farm in the relative time period.

Del Monte, as part of its case against FDA, argues that its food safety program would have prevented such occurrences. Third party audit findings from April, 2011 showed a high degree of conformance with industry standards by this facility, but auditors also found that some sanitation controls needed to be improved. Results of third party audits of the packing facility in question suggested two important corrections:

• ·         Covering an exposed sewage ditch
• ·         Incorporation of daily cleaning and sanitation of the dump tank

FDA #22-03 Import Alert

In July of 2011, FDA banned products from the Asunción Mita facility, concluding that they were produced under insanitary conditions and that they likely contain Salmonella. FDA recently lifted this ban.

In its import alert, FDA recommends that based on previous experience, its food safety personnel should evaluate the following risk factors:

• ·         Safety of water used in irrigation, packing and cooling;
• ·         Manure use and bio-solids, 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.

 Lessons from this event

At this time FDA has not made public its findings from the inspection of the Asunción Mita packinghouse, but some information about sanitary conditions have been reported by third party auditors. A reference for this can be found in a report by the Florida Center for Investigative Reporting.

Covering an exposed sewage ditch

It is not perfectly clear what the source of this sewage is, whether it is “black water”, meaning waste water from toilets and hand sinks, or “gray water” meaning spent water from other sources (wash flume water, floor drains, drainage from refrigeration, etc.).

Regardless of its source, such wastewater is a potential source of pathogens, and facilities are required to dispose of it safely.

In many regions, we rely upon sewage disposal rules written by health agencies for the collection, transference, treatment and disposal of wastewater. Ideally, there is an enclosed piping system to convey the wastewater to a treatment system before disposal of the effluent, such as into the soil in subsurface septic systems. Such effluent can also be discharged directly into a sanitary sewer if one is available, or treated in an onsite sewage treatment system before discharge into a flowing body of water.

In no case should untreated wastewater, or "sewage" as FDA puts it, from a produce operation be disposed of in a ditch, onto the surface of the ground, or discharged into a body of water.

There may be no rules for wastewater discharge in some agricultural operations, or operations may be loosely regulated. This is often the case in the developing world, or in remote rural locations. In such cases, decisions about what to do with wastewater are left up to plant personnel who may lack knowledge of sanitary wastewater disposal. Unsanitary wastewater discharges and lack of compliance with environmental regulations can unfortunately be found in some produce facilities.

Opponents of government regulation should be aware that the imposition of consistent sanitary waste disposal methods are a hallmark of public health controls. Where these are enforced, environmental exposures to sewage are greatly minimized. Where there is no regulation, such hazards are likely to be forgotten or simply not addressed and create problems.

Incorporation of daily cleaning and sanitation of the dump tank

Not all produce is washed before being packed; in this case the facility did wash its melons. The common practice of field-packing, meaning packing directly into boxes or other containers as the final unit-packaging, is common with several commodities, and has some serious concerns.

In certain cases, makeshift washing in the field occurs, such as in barns using tanks of water. In many farming areas water is a precious commodity and is reused. A tank of water used to rinse produce in a barn may remain for an entire day without changing. Thousands of individual pieces of vegetables may be so exposed to pathogens if even one unit has contaminants. To say that on-farm washing systems like this are antiquated is an understatement.

It is a mistake to assume that water used for field packed product is even potable under the meaning of the law. The US Environmental Protection Agency (EPA) provides the standards for potability of water. Because there is yet no clear government regulations as to the application of potability standards to water used for washing produce, the industry relies on periodic microbial testing of water and the available research and advice of experts. Usually, the produce industry relies on tests for the coliform bacterial indicator group to gauge microbial quality. Where a satisfactory result of < 1 CFU in a 100 ml sample is obtained, the water is considered potable.

However, wash water is rarely tested “in process”, the operator assuming that periodic testing of the water source and treatment is all that is necessary. This is often the case where packinghouse operations use washing systems consisting of sprays or flumes.

The third party audit findings for this operation indicate that the facility in question “dumped” its products into a tank of water (dump tank), and that the frequencies for changing this water and cleaning the tank were questionable.

It is common to see confusion on the part of operators of produce packing facilities as to how to control the safety of process water. What the industry has done in past years to satisfy buyer demand for a product that “looks clean” may cause an exposure if re-circulated water systems are not properly tested, treated, cleaned and maintained.

We must improve our controls for process water, but questions remain: How to do we treat such water? What antimicrobial to use? And how do we test its efficacy? And very importantly, what do we do about improvised washing methods often used in field packing?

Listeria Outbreak in Cantaloupe

On September 14, 2011, FDA issued a press release to announce that Jensen Farms, a Colorado operation, issued a voluntary recall of its Rocky Ford-brand cantaloupes after being linked to a multistate outbreak of Listerosis.

At this time there have been 21 deaths and 109 people have been sickened in the outbreak — including the 21 dead — in 23 states from California to the East Coast

Read more:

(To be continued in Part 2 of this four-part series).