Many produce firms have adopted Hazard Analysis Critical Control Point systems, only to find that when they are audited, there are major deficiencies and non-conformances.

We are offering a HACCP class that addresses the major issues in developing and implementing produce HACCP plans. This course will provide you with the following:

·         A solid overview of the 5 preliminary steps and 7 HACCP principles as outlined by the USFDA and CODEX Alimentarius.

·         A step by step process for building your HACCP plan

·         They key elements of HACCP audits under GFSI and Standard Primus and how to comply

·         A certification that is recognized throughout the world

This is a workshop format and most of the class work is done by teams, so there is a great degree of interaction.

Please plan on joining us, and if you have already been certified under this program, pass this information along. This class is offered a few times a year so please take advantage of this opportunity if you need it. If you have a HACCP plan we will show you how to tighten it up, if not, its best to come prepared at least with an idea about your process and flow and we will walk you through the process.

Thanks and we look forward to hearing from you. Click link below for registration form.

 www.safefoodsblog.com/uploads/file/Deland_Produce HACCP trainingflyer.doc

One of the hallmarks of protecting the fresh produce supply is a concept known as “buyer-driven” food safety controls. In the absence of regulations, the produce industry has been working under private standards drafted by the major buyers of produce, meaning the large retailers-the major supermarket chains. While the need to satisfy the retailer that foods supplied to them are safe, retailers themselves have been less than effective in ensuring that the people they commission to buy for them, their own “buyers”, only deal with operations with acceptable food safety systems.

This means that many, if not most retailers, will buy produce from firms that have not been verified by competent third parties or by the retailers themselves (second party verification), when it is opportune for them to do so. For a revealing piece on this issue see The Perishable Pundit:


The sad truth is that when buyers can get produce from a vendor at a cheaper price, the requirements for safety take second place.

Even worse, buyers utilize the unapproved firm as a lever to get the operator with a food safety system, and subsequently higher production costs, to lower their price.

Even small operations may invest hundreds of thousands of dollars in satisfying the strict rules of the Global Food Safety Initiative (GFSI). Often, firms must hire food safety personnel due to the overwhelming amount of self-inspection and paperwork involved. Laboratories and auditors must be paid for. Many times there are requirements for structural improvements and maintenance, chemicals to clean and treat water and many other similar costs to be borne day in and day out by suppliers. Thanks to the attitude of the major retailers, these suppliers cannot typically charge more for their products, and must absorb the costs as best they can while trying to stay competitive.

It is unfair to say the least that buyers for the major retailers would use the lower priced unapproved supplier as leverage to keep down their costs. Instead of rewarding suppliers for diligent efforts that not only protect the retailer, but public health in general, they are causing animosity; many conscientious produce operators are indignant at the current double standard, but the fear of losing customers precludes most of them from expressing their exasperation.


"Food safety culture" is a much used phrase and one preached to the supply chain by many of the world’s largest retailers. Retailers should be reminded that food safety culture begins at home, and such talk becomes a mockery in the eyes of the producer when retailers say one thing and do another.

Not all produce firms have had an opportunity to be qualified by third party accreditation under any private scheme, but the population of certified firms is growing, Part of the reason for the shortfall is that the auditing firms performing such audits are themselves overwhelmed and lack the necessary manpower.

In order to maintain pressure on the supply chain, the buyers for the major retailers have set deadlines for compliance, but then have to announce that another grace period or extension has been granted. Some relatively large producers of fruits and vegetables have just decided that the retail communities demands for conformance with third party food safety standards is a bluff and carry on business as usual; and they find most retailers are willing to buy their products anyway, on the basis of price and quality.

Lawsuits involving the produce industry cost retailers many millions, however, too many are seemingly willing to take a chance as long as the short term economic benefit is there.

I am sure the food safety experts at the nation’s leading retailers cringe when their buyers go outside the approved supplier list, yet the corporate decision makers do not always value a food safety department’s input.

Again, this is not “food safety culture”, when a firm puts short term profits over safety and public health; this is the antithesis-corporate greed.

Such business practices are undermining food safety efforts and causing many a bitter attitude among firms who have invested millions over the years to satisfy the demands of retailers, only to have their competitors flaunt such food safety efforts and prosper.

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FDA once again on the basis of detecting a Listeria contaminated product, finds insanitary conditions at a producer, this time at Henrys Farm Inc. of Woodford, VA. It would be much better for everyone if FDA had found these conditions beforehand. These repeated exercises by FDA should be a warning to the produce industry, that sanitary conditions in produce operations need improving across the board. It also points to the tremendous job FDA will have in cleaning up the produce industry, if and when they are able. Until then, it appears reacting is the best they can do.
Here are the findings as published by Food Safety News:

– Rodent pellets in bags of mung beans, along with gnawing on 25 kg paper bags of soybeans located in the refrigerated seed storage section. and in a shed 200 feet West of this storage area. FDA reported "a foul odor consistent with rodent infestations associated with the shed."
– Gaps under the door to the refrigerated seed storage area and holes in the ceiling of a shed containing soybeans 
– A hand-washing sink draining used water onto the floor
– An accumulation of debris in the exit bin of the wash chute leading to the sprout air dryers and packaging machine and on the underside of a conveyor belt that transports soy beans.  
– Loose metal burns on the metal mesh conveyor belt in the sprout processing area measuring about a quarter of an inch around. 
FDA also charges Henrys with misbranding its product, saying the company’s sprouts failed to bear a label including the name and place of business of the manufacturer or the net quantity. 
Who are the commercial buyers and distributers of these products? Do they have a clue what they are buying and selling? Food safety at this level of the produce supply has a long, long way to go.

Bill Marler, arguably the leading legal mind in food safety today, is not pulling any punches when he points out the deficiencies at Jensen Farms.


The shocking truth is that the old ways of doing things in the produce industry must quickly come to an end. We cannot continue to hide from the truth. We should therefore be very worried about the future of the fresh produce industry, and do whatever we can to save it.

The following is my take on what it will require to satisfy any future due diligence defense, in the event that the unthinkable happens, again.

1.       Equipment design

All equipment that touches a produce item at any step of production must be stainless steel and NSF or UL approved, or equivalent, and otherwise meet the requirements for food contact surfaces as outlined by the USFDA Food Code. Any part of any piece of equipment that touches produce, whether the produce surface is part of the food, or is inedible, must be certified as safely designed. Existing equipment must meet the same requirements or must be dismantled and removed. This also applies to retail operations where produce is displayed handled and/or sold to the consumer.

Non-food contact surface of equipment shall pass equivalent qualifications based on a risk assessment.

2.       Facility design

Every facility that handles produce from the packing shed to the processor or cannery must be designed by a certified designer and pass a plan review process governed by a legal authority before construction. All such facilities must be inspected by a government entity and approved before operation. Existing designs must be brought up to standards immediately or cease operation. This also applies to the retailer.

3.       Potable water

Only water that has met the chemical, biological and radiological standards for potability may contact produce at any stage of the growing, harvesting, packing and processing chain. This includes the retail level. All water supplies used anywhere in the produce industry must be approved prior to construction. Existing systems must be immediately resigned or abandoned if they cannot meet such requirements

4.       Personal Hygiene

All persons handling produce at any step of the supply chain must be certified to be in good health on a frequent basis, and may not touch produce with bare hands. Adequate plumbed facilities that include approved waste disposal and hand washing must be provided anywhere produce is produced or handled.

5.       Food Safety Management Systems

Food safety management system that includes a hazard analysis of each step of production must be in place at any produce operation, with the controls verified and validated for effectiveness by a competent authority having jurisdiction. This applies to the retail level.

All produce must be treated to reduce pathogenic microorganisms to a safe level. Such treatments must be validated as safe and effective and included in an operations food safety management system. Such management systems must include a microbiological testing program for all water used, all surfaces touched by produce and the general environment, in process tests as well as end product tests to verify the effectiveness of controls, irregardless of the type of commodity. Such programs shall show the continuing absence of pathogenic microorganisms.  The application of the HACCP risk assessment concept as outlines by CODEX is mandatory to apply to all such testing program. Such risk assessments shall apply starting at the seed supplier level then proceed from the farm level through retail.

The retailer shall provide the same levels of safety controls and testing as his suppliers for products under his immediate control.

6.       Industry level food safety controls

No buyer shall purchase produce without first ensuring first-hand that the operation meets all the safety requirements as stated above. The use of third parties are only an option when the retailer pays for such service and the service is itself accredited by a competent legal authority who has enforcement power over both the third party and the buyer.

7.       Government level public health controls

No produce operation shall be allowed to operate without first obtaining an approval from a competent authority having jurisdiction. Such authority shall make frequent inspections of such operations as often as necessary to ensure compliance with laws and rules governing food safety and take the necessary action to protect the public when needed.

8.       Traceability

Every individual unit of produce shall bear an identifying code that at a minimum is traceable through every step of the supply chain. Such coding shall be maintained by the retailer so that in the event of a recall, the public will know exactly which producers and handlers are involved. This information shall be made immediately available to the consumer in the event of knowledge of a hazard or risk to public health.

9.       Transportation

Any means of conveyance of fresh produce shall be designed and operated according to these same requirements and under the control of a competent legal authority.

10.   Education and Training

No entity shall operate any produce type operation until all management level personnel can demonstrate knowledge of food safety, food safety management systems and HACCP through the taking of an accredited course of instruction and pass an accredited examination. No employee shall work with produce in any capacity without having taken and passed an approved food safety training program that includes the principles of HACCP.

11.    On farm risk assessment

No farming operation shall be used to grow produce for human consumption without first meeting the approval of a competent authority having jurisdiction. Such approval shall be based on a risk assessment that shows there is no reasonable threat to public health from any feature of the growing operation or surrounding environment

12.   Consumer Education

The produce industry shall fund, create and market the best practices methods for safe consumer handling of its products. The effort must be a national campaign and designed so that consumers know the unavoidable risks of eating fresh produce and the safety precautions they can take. Such campaigns will use current media, retailers shall make such educational materials available to consumers at the point of sale, and poll consumers to gauge the effectiveness of the outreach efforts and publish the results.

Nothing affects everyday people every day more than the food they eat. So stories about food generate lots of interest. Of course, we all want our meals to be safe, and the industry takes precautions to try to ensure that happens, but in produce safety, there are a lot of misunderstandings and wrong things being said today that have the potential to do more harm than good.

The produce industry has accepted that it has a hazardous group of products, which include melons, berries, leafy green vegetables, cucumbers, papaya and tomatoes, among others. Industry has attempted hazard control since the early 1990’s when produce-borne outbreaks became widespread. At that time, there were few if any requirements for microbial food safety down on the farm. Such efforts now include testing of irrigation water, safe use of fertilizers, exclusion of farm animals, personal hygiene, and the sanitation of the on-farm operations (such as the packing shed at Jensen Farms), but we are not moving fast enough. Keep in mind the demand for fresh fruits and vegetables has increased exponentially in the last 20 years.

We are still waiting after 20 years, for a coordinated effort by government, industry and academia to right the wrongs of the past.  What we see in this long drawn out scenario is the basic collapse of our public health infrastructure and our inability to address the shear magnitude on farm environmental health. Years of neglect and political interference have marginalized FDA and public health programs across the board, and it is anybody’s guess what if anything can be done now to improve produce safety. We should probably expect from FDA no more than expanded produce guidance documents and the investigation of third party failures, at least for the foreseeable future.

Guidance is OK (although not completely thought out, or so it appears) and we have a good supply of reports, but FDA admits that application of its guidance documents is not universal; in fact FDA does not know to what extent the industry has adopted these self-stated voluntary programs, or their effectiveness.

Within such a vacuum, industry to protect its vital interests has developed numerous food safety schemes and programs with food safety auditing being one important tool in the tool box. An on-farm food safety tool kit contains science- based standards, lab support, traceability systems and educational programs. All of these programs have spun off businesses that have evolved in the vacuum of regulation.

To expect business interests not to affect a private food safety system is totally naive. To expect auditors to become experts in all the different schemes and guidance may be reasonable from the point of view of FDA, but the reality is that the auditor workforce suffers from the same sorts of deficiencies as many government agencies in terms of knowledge and experience. It is important to point out that new skills are needed in a new discipline such as environmental health down on the farm. That not all risks and not all controls are known on the farm, is a given.  To expect auditing companies to mandate and enforce a plethora of rules and demand strict adherence when even our government cannot do this and the science is not strong is ludicrous.

Criticism does come with the territory. Auditors like their close cousin’s “regulators”, are attacked whenever food safety problems come to light in their jurisdiction or sphere of influence. We must grant however, that overlooked gross deficiencies should not have occurred in any proactive and effective system. There should not have been dozens of dead rats on the floor of PCA.  Jensen Farms should not have had water dripping from overhead areas on to products.  Con Agra should not have operated a peanut butter plant with a wall down and raccoon tracks on the floor of production areas. These obvious problems should have been caught by the auditor or inspector, if not by the firms themselves. These firms should have been proactive, instead some forms just wait around for an auditor to correct deficiencies. This is actually another story that needs be told, and probably a more important one for the advancement of the cause then the constant bashing of auditors and such firms.

In the case of the auditor, what follows negative findings? The auditor writes a report and it gets submitted to a buyer, buying decisions are made, and the auditor moves on. There is no mechanism to enforce anything, or re-inspection, which only exists for his inspector cousins.

Overlooked sanitation issues are troubling to the auditing community because most auditors do catch such obvious defects. Third party assessments are mostly effective; but how effective, none can tell. As in any prevention program, there are no data to show how many outbreaks would have occurred in the absence of such audits. Nevertheless, we have had 2 terrible audits linked to 2 massive outbreaks. This does point to problems in the system, and more discussion will assuredly produce more questions. In essence, what we are seeing is the marginalizing of public health protection by the business model; the model the industry has had to rely on since there are few other public health protections available in farming today.

The media feeding frenzy over this topic will continue until the bare bleached bones of these hapless auditors are exposed for all to see. But just remember that these systems were developed by the buyers to assure a continuing supply of safe fresh fruits and vegetables, not as a defacto regulation of the industry, and auditors are not regulators.

And to my media friends, please also check your facts, stop repeating mistakes like the “Primus auditor should have required the melon wash water to be chlorinated” when the 2009 FDA melon guidance does not require it.

In your frenzy, remember that third party standards are all the public has to protect them, right now.

So OK USA Today, fire away.


As we trudge along in food safety at the farm level, the sense of desperation is obvious, but there is hope and movement forward. 

Not only is the produce industry reeling from the recent food safety disasters in its products, the pressure is on in the labor market and on the economic front. Growers and packers of fresh fruits and vegetables seem just as isolated as any group in their problem. They are seeking help, and this is positive, and the answer may be a more cooperative approach. 

We in food safety must realize we are superimposing a self-regulatory and soon to be regulatory framework on an industry that has not had this to deal with.  FDA is supporting industry efforts to self-regulate, and the two together can accomplish much, but we still need produce industry specifications for suppliers based on sound science.

The article below makes a point of the need for cooperative efforts amongst industry and government. Part of that is for FDA to ensure that the standards industry uses to assure safety are effective in very diverse crops.

Some of the audio is a bit garbled, but Tony Piedimonte of Florida’s Wm P Hearne company makes some salient points about the industry stance. 

Thanks to the Packer for covering the following story. 


While the Environmental Health professional’s role in food safety is marginalized in some places (such as in Florida, where the Environmental Health staff conduct less than 10% of the food safety inspections) there is a growing need for their involvement directed toward the safety of fresh produce.

With experience in the safety of water, land use, plans review, wastewater disposal and treatment, soils, vector control, the use of sanitizers, pesticides and the like, I believe the environmental health profession holds one of the best, tangible responses to today’s produce dilemma.

Unless adequate funds become available, the Food Safety Modernization Act, the federal response to the current public health crises affecting our nation’s primary producers, will not provide the solution.

The impact of the repeated outbreaks of foodborne illness should be a stern warning to our nation’s legislators, but they seem oblivious to the problem. When 30 people die from tainted cantaloupe, bells and whistles should be sounding in Washington; instead, its dead air in D.C.

If a terrorist attack killed 30 Americans, would our nation’s leaders say, ”We cannot afford a response…?"

If FDA cannot do this job alone (and why should they?), then we have an untapped resource in our County Public Health Units. There are over 3,000 health departments in the US, with more than enough infrastructures to support the produce food safety regulation/enforcement task, both in facilities and on farms. If properly trained, managed and funded, environmental health professionals could expand the roles they now play in protecting public health, into agriculture.

Rules must be developed and the inspection workforce needs to be trained in a somewhat new discipline, but the qualified Environmental Health Specialist has the capabilities needed now. With proper guidance and support, they can be effective in produce facilities and on farms.

In addition to our local public health professionals, there should also be an expanded role for state Departments of Agriculture and even USDA to help fill in the gaps in produce safety regulation and enforcement.

While we search for ways to prevent the next food safety disaster, consider properly funding and supporting local environmental health protection efforts. Give our county public health units what they need for the effective enforcement of laws and rules and we will see a reduction in foodborne illness.

Lessons Learned From Foodborne Illness Outbreaks

Part 2.  

Listeria Outbreak in Cantaloupes

 “They probably look at themselves as victims too, but as between the person who bought the cantaloupe in the grocery store, who is more of the victim? And does a grocery store have an obligation to its consumer to not sell them products that are contaminated and from entities that have limited assets and insurance. That’s why it is 100% likely that this cantaloupe outbreak is going to bring in everybody in this outbreak, including the retailers and the auditor and Frontera and Jensen Farms because that’s the only way that the victims – whom we all would agree have far less culpability than the other side of the equation – that’s the only way that these people are going to be fairly treated. But it’s going to be a battle”.  Bill Marler.

The Listeria outbreak in cantaloupe is still producing cases. Much has been written about the responsibilities of all involved and what needs to happen to correct deficiencies in our approach to food safety in produce, along with much sadness and much controversy.

As attorney Bill Marler has said in this exceptional interview in the Packer, the legal associations of the packinghouse, retailer, distributor, auditor and consumer are clear, and it is sobering.

Reflecting on Mr. Marler’s perspective, we will look at the chain of legal liability and see how it intersects with the chain of causation to see if we can learn something from these monumental, tragic and frightening events.

One must look at the disease pathway to see the intersections clearly, and it is a complex scenario with Listeria monocytogenes due to this pathogens ubiquitous presence in the environment, its likely ability to create bio-films on the surfaces of plants and inanimate objects and its propensity to cause serious illness in the immune deficient.

In terms of the infection pathway, we do not know whether the causative agent spread to the packinghouse and colonized the equipment, or the equipment was already contaminated by another farming operation due to previous use and spread to the packinghouse as pointed out by FoodSafetyNews.

What we have learned is that conditions at the packinghouse allowed propagation of Listeria monocytogenes at this site, and subsequent conditions eventually affected the entire supply chain. Additionally, contaminated products continued to be sold for an extended period, revealing our failed traceability systems .

On the packinghouse level, once the environment is contaminated, Listeria monocytogenes can spread throughout production and create niches for growth. That conditions were ripe for this at Jensen Farns is now clear, but unfortunately in hindsight.

On the product level, we know from FDA that cantaloupe is potentially hazardous, but this hazard was believed to occur only after cutting the melon.We did not understand the clear probability of the pathogen to not just colonize a melon surface, but also proliferate on it.  I believe this chain of causation probably involves growth conditions for the pathogen on the surface of the melon, probably post washing. This phenomena should have been realized, but it was not.

The temperature controls at Jensen would not have been sufficient to control LM after colonization of the melon. Growth would begin at the packinghouse cooler and continue through to the cold-supply chain. Any increase in temperatures in the supply chain would result in accelerated growth, thus amplifying the problem for the next user.

At the level of the buyer, the buyer is obliged to ensure conditions at its supplier do not render a product adulterated. The buyer should maintain controls over the supplier. These can include test of water, tests of products, independent audits, self-audits and second party audits along with letters of indemnity and guarantees. Given that the buyer receives products that may be contaminated, controls should be in place in further distribution to reduce the likelihood of any dangerous product reaching the consumer, pointing to the need for more testing nearest to the consumer level and traceability.  It’s interesting that industry has vigorously opposed the random testing of products and has effectively killed some of these programs.

That all involved in this distribution chain now bear responsibility is clear. This is not the first outbreak of a pathogen in cantaloupes. That our standards for handling cantaloupes were too low is painfully clear.

At the level of supplier control, the retail industry must start getting smarter about how to qualify its suppliers, currently the industry-required tests of finished products may be driven by a poorly defined risk assessment, or simply rely on industry practices, The bar is now raised extremely high for quality assurance in the produce industry and we should see a move to integrate technology into the food safety effort at a very high level, especially traceability and end products testing. We should see a major emphasis on water quality, in in-process tests and final tests for products, whether they be directly from a farm, from a packinghouse or from a processor. If there is a gaping hole in the producer-buyer-retailer food safety net, it’s the failure to adopt the best microbial standards and best quality assurance standards and traceability for producers.

At the level of the consumer, an acute problem arises with controlling Listeria. Refrigerator temperatures would not be able to prevent the slow the growth of LM; there have been no consumer advisories on how long or at what temperature to keep whole cantaloupes, making this a unique challenge for the consumer.

This melon’s netted surface hinders removal of LM (especially in a bio film) making washing by the consumer of little effect.  Before, during and after preparation, it is common for consumers to leave food before serving without temperature controls and to put the leftover items away at some latter time, potentially allowing proliferation in the cantaloupe meat.

Unfortunately, we have not properly educated the consumer about the intricacies of food safety and they simply do not know in every case of contaminated product hitting them, what to do.

But as food safety professionals, we should know what to do.

Events like this can trigger a bit of fear. In a twist of fate and circumstances, I was auditing a firm less than 100 miles away from the site of the Jensen Farms outbreak about a week before the fateful Jensen Farms audit. I met with farmers just like Mr. Jensen.

I have to ask myself, if I was the auditor, would I have spotted the inconsistencies in production?

Would I have understood the critical environmental factors I was seeing and understood the entire process and its role in the growth of LM?

Would I have appreciated the relationship of the factors I was looking at and reacted to the risk of the survival and growth of Listeria monocytogenes on the surface of Jensen Farms’ melons?

The answer could be frightening. No, I may not have realized the conditions were ripe for a Listeria outbreak the has killed 28 people to date.

This is a gut wrenching realization and one that has been with me since the day this outbreak began; if we are going to truly perform a valid risk assessment, we need to be carrying a very big bag of tools.

The audit instrument is best used like a surgeon’s scalpel. The scalpel is best for delicately separating the good, from the excellent, from the superior. Sometimes we need a hatchet for the ones that need it, and all we have in our tool kit is a small knife.

We should ask about FDA’s prevention role, and the role a strong FDA might have played in preventing this outbreak; and ask about the regulatory scenarios moving forward. Certainly, these events point to the urgent need for FDA to come in and level the food safety playing field.  But unfortunately, no one wants to pay for the FDA to do its best work, so now the auditor, the consumer, the packinghouse, the farm the processor, the retailer and the consumer must pay.

Thanks to the strength of our legal process and the skill of our legal firms, that there will be justice in the end. This would bring closure for me, except for the fact that our public health structure is letting us down and my efforts without that crucial element will be forever flawed.

I predict we are going to see more sad stories, failures and more finger pointing, and maybe rightly so.

Lessons Learned-

If there are more hazardous facilities out there, they need to be identified, repaired, or closed.  

All produce facilities should be reviewed to make sure they have the correct infrastructure, ideally, before they are allowed to operate.

Buyers must insist on the application of the best quality assurance methods and traceability systems.

Food safety efforts from farm to table need proper financial support.

There needs to be less politics played with food safety and a cooperative effort byindustry and government to protect the consumer.

The education of the American consumer about food safety is woefully lacking.

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).

Environ Health Associated investigated the efficacy of a product known as electrolyzed water on reducing hazards in salad greens in colaboration with ProtonLabs and the University of Washington. The findings have been published in the Journal of Food Science. Our study found that when used on  experimentally contaminated leafy greens an electrolyzed water wash treatment provided a reduction to safe levels in about a minute and complete destruction of all pathogens to undetectable levels after 3 minutes. This technology developed by Protonlabs in Japan has the power to transform the safety of leafy greens. Unfortunately less effective technology developed in Russia has been heavily marketed already in the US, while the Japanese technology is just becoming well known. Environ Health Associates believes this study will open doors for Proton’s Japanese technology that were previously closed to the Russian technology.

What makes the Japanese technology an improvement on the Russian technology is the robust hardware, advanced electronics, and stable chemistry provided by the maunfacture. Environ Health Associates endorses ProtonLabs’ technology. ProtonLabs is the only company offering an effective stabilized electrolyzed water product that can be bottled with shelf life at 2 years under normal storage conditions.

The study showed that an ordinary washing step with electrolyzed water provides an excellent reduction in pathogens and a safe alternative to other treatments. Electrolyzed water resolves to its elemental components with no residue in the environment. The active ingredient, hypochlorous acid (HOCL) is accepted as GRAS by FDA and can be applied to all types of edible foods, including organically grown vegetables.  

Continue Reading Break Through in Produce Safety