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.

www.marlerblog.com/lawyer-oped/should-brothers-ryan-and-eric-jensen-face-criminal-charges-will-producers-of-listeria-tainted-cantal/

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.

The verification of supplier food safety has emerged as a critical component of a retail operation’s Food Safety Management System (FSMS), but we continue to see Subway stress supplier safety while poor management of its own operations results in outbreaks of foodborne illness.

See Bill Marler’s Food Safety News to learn how a Subway contributed to a community wide outbreak of norovirus gastroenteritis.

http://www.foodsafetynews.com/2012/07/sick-subway-employees-went-to-work-during-norovirus-outbreak/

In light of the costs borne by the supply chain to satisfy retail industries’ high standards for prevention, it is unfair for a firm as influential as Subway to have lax control over its own operations.  

It’s critical to have safe lettuce coming in the backdoor, but if an infected employee handles it, it negates all the costly prevention done upstream by suppliers. The revelation that this was allowed to happen creates animosity on the part of suppliers and undermines Subway’s own efforts at supplier control.

Subways’ food safety management system failed as the result of poor decision making; what we see here is the failure of food safety culture. Subway has an obligation to consumers who expect the company to be a supplier of safe wholesome food. Subway has an obligation to its suppliers to maintain the same vigilance over food safety they expect from them. By failing its obligations, Subway risks the reputation it has built, and the value of its brand.

As consumers, we should expect MUCH more of Subway. As food safety professionals, we should ask “what is the root cause of this failure” and “how best can Subway’s management solve the problem”.

To  post guest’s articles, please contact rcosta1@cfl.rr.com

A Consumer Looks at Food Safety

 by Lauren Bailey

It’s a sad fact that many food safety hazards and issues are discovered by accident by a consumer. Consider any food safety scare from the last year: the Jensen Farm cantaloupes from Granada, Colorado, or the E. Coli outbreak in Europe, two huge stories that point to the overall fragility of consumer health and the hefty responsibilities of the food industry. Food safety is a chief concern among U.S. health officials precisely because it involves the entirety of the American people, and yet big mistakes seemingly occur every year.

As consumers, we largely have to assume that wholesale food producers know what they’re doing; we implicitly trust they are meeting regulation standards and that those standards are sufficient to ensure our safety. Every time we purchase of raw fruits and vegetables, when we pick up a cut of meat at the butcher’s, we do so on good faith that the food won’t harm us. But more and more often we hear stories that give us pause over our long-held faith in food. I think these popularized food safety issues are one of the greatest challenges facing the American consumer today.

Allow me to elaborate.

A New Headline Every Day

Whether it’s a story about “pink slime” in processed beef products or alarming BPA levels in canned goods, there’s always a new food scare driving the health section of popular media outlets. It’s enough to create a perpetual atmosphere of fear and distrust among many consumers. But the unfortunate truth is that these huge food scares usually revolve around a highly isolated incident—maybe a dozen people fall seriously ill over a certain contaminated good. But the backlash that follows the story will completely cripple any producer of that good, even if their facility was in no way involved in the food scare. People will understandably have a knee-jerk reaction to stories about potentially hazardous foods if they hear about it 24/7.

In the case of the Jensen Farms cantaloupe scare, with the ensuing listeria outbreak, people steered clear of anything having to do with the fruit for a good while. The infamous case of E. Coli and bagged spinach a few years ago severely hurt overall spinach sales, even though the outbreak was traced to specific producers and not to all spinach sellers. If consumers are told to be wary of a food, they’ll listen. But why is it that we get the most information about food safety from these isolated incidents, and not from the producers themselves?

More awareness in supermarkets

It seems to me that the first step to increase the average consumer’s awareness of food safety should be taken by food producers and distributors. Whenever you step into a supermarket, the only signs you’ll encounter will be those advertising the cheapest deals on goods. Or you’ll be met with a gaggle of products that exclaim their organic or whole grain components. Not enough grocery stores (nor the food items that they sell) warn consumers about the potential health risks of certain foods. The recent CDC report concerning the high sodium consumption of most Americans confirms as much, because the vast majority of us consume far more sodium than we would believe. We do this because it’s never completely clear how much sodium is in many processed or canned goods. We might be able to read the sodium levels on a product, but without a means to contextualize those numbers we won’t know what to do with them.

It’s the same case for any component of a food that’s detrimental in excess: fatty foods, sugary foods, highly processed foods all need to be much more clear about the health risks they pose to the average consumer. If the food industry doesn’t take steps to be more transparent about health benefits and risks of their products, then we can probably expect many more isolated food scares that probably could have been prevented.

By-line:

This guest post is contributed by Lauren Bailey, who regularly writes for accredited online colleges. She welcomes your comments at her email Id: blauren99 @gmail.com. 

I am for a more fair system when it comes to inspections and grading. The grading numbers may not mean much, and this is because inspections are snap shots of events and there are all sorts of bias and human elements. However, when the facility maintains its records of food safety efforts, its more like seeing a moving picture. When inspections or audits make an evaluation based on what they see, and what they determine to be required in the firm’s food safety program, now you have something that has the ability to be meaningful. Its the firm’s daily practices that will make or break a sanitation program. Lets start evaluating that. 

But wait, that means a food service operation has to have an internal food safety program to evaluate! 

Too bad restaurants don’t have to do have one, its not required, they "just follow the code". 

That mentality doesn’t work and all this controversy about grading being a poor measure is true; but it is just a subterfuge for the fact that the FS industry as a whole will not agree to a mandatory self-control program that would allow checks and balances. Fortunately, most of the rest of the supply chain has. 

Here is what the FRA has to say about grading in 2005,

http://www.wftv.com/news/news/no-state-issued-letter-grades-for-restaurant-inspe/nJwwH/

and thier stance has not changed, in aspite of the fact that reports from agencies with letter grading support risk reduction has occurred. 

If this is to catch on we have to overcome some of the problems that are rightly recognized. Its just we have not understood what food safety management is and applied it to Food Service and this means we have no real measurement we can rely on. 

The latest pushback from NYC. 

NEW YORK: City Council throws rotten tomatoes at restaurant grades
11.mar.12
New York Daily News
http://www.nydailynews.com/opinion/city-council-throws-rotten-tomatoes-restaurant-grades-article-1.1036545?localLinksEnabled=false
It is but a slight exaggeration to say that everyone who eats in a restaurant in New York City — which means essentially everyone who lives, works or visits — loves the A, B and C placards posted in eatery windows.
Those grades, based on Health Department inspections, have had powerful effects. They have improved restaurant sanitation, reduced food-borne illnesses like salmonella and boosted business at restaurants that have earned the top mark.
What’s not to like?
Ask the City Council and Speaker Christine Quinn.
The industry has fought letter grading from the moment the Bloomberg administration floated the idea. Restaurateurs have griped repeatedly that inspections are too tough, fines are too high and the marks are based on poorly chosen criteria.
Now, Quinn & Co. have produced a survey purporting to find that the program desperately needs reform. A questionnaire asked restaurateurs their opinions about the grading. Of the city’s 24,000 restaurants, 1,297 responded.
Based on the survey, Quinn is calling for a reevaluation of the violation system, an ombudsman to adjust inspection results before hearings are held and an “early warning system” to weed out supposed inconsistencies in inspections.
She needs to get specific and prove her proposals will not undermine the most important consumer protection in recent New York memory.
 

Its evident that the FDA regulated food industry does not want to pay user fees. With the political climate being what it is, FDA may not get sufficient funding to carry out its mandates.

 

If this is the way government and industry decides on what is best for the public health, then the consequences need to be assessed and some sort of alternative developed. See:

http://www.foodengineeringmag.com/articles/print/88970

 

The problem is that there is no united opinion on on how best to develop an industry led government-private sector initiative that is universally adopted. The the current system of competing private standards has shown its limitations and we need more than this.

 

The FSMA should become the universal standard for industry compliance and conformance, a radically new approach, but totally common sense.

 

Much of what the FDA says needs to be done can be done through cooperation, allowing FDA to take a less aggressive position in regulation, This can happen only if voluntary compliance will work and industry will accept FDA standards as the bible, and FDA as the leader.

 

The potential savings for everyone could be maximized by developing the key programs and criteria that could be used by industry to support the FDA mission. If industry wishes to keep the current model of self inspection and provate standards, in line with the new model of mandatory reporting of FDA compliance, all the better.

 

Furthermore, FDA should start discussions about interagency agreements and contracts with state and local health departments to provide manpower to see how much can be saved through this approach.

 

Beyond the current FDA guidance documents, I propose a system that relies on mandatory reporting by the private sector to government.

 

This measure is not as perfect as an FDA inspector in the field. but competent industry personnel, working under strict management and oversight of FDA is a good half way point.

 

The electronic reporting requirements can easily be developed. FDA manpower and technology could better be used in this approach.

 

As a minimum I would suggest:

 

  1. Establish the food safety criteria to be used by FDA regulated segments, starting with the highest risk operations and develop reporting formats, this should move ahead if the funding issues can be dealt with
  2. Establish the qualification for third party second party and first party inspection for each of the critical sectors newly under FDA, this has to be done anyway
  3. Develop the oversight standards of the agency, not limited to frequency of reporting, criteria for determining risk, and interventions
  4. Establish the reporting database and security measures for the data entry

The application of technology is a key benefit in moving forward, especially if funding is minimal as predicted. Industry already has the experience in electronic reporting, and government should work with industry to further develop the methods already in use to collect and disseminate food safety data and manage risk in the food supply.

 

Instead of fighting over money, I would suggest a new spirit of can do and a frank discussion of how we can help one another.

 

As an environmental health professional, I have enjoyed a successful career in hands-on food protection from farm to table. My success in this wide array of conditions has come through the effective application of environmental health principles.

Nowhere in food safety today is environmental health needed more than down on the farm, where the environmental health risks factors are becoming better understood. As a sanitarian and independent food safety auditor, there are some key areas of environmental health in my work on the farm; water quality, animal control, and worker hygienic standards. Private food safety auditors have started calling these the "Three W’s" for Workers-Water-and Wildlife.

Typical Tomato Reusable Harvesting Container Rinse Typical tomato wash water used to rinse picking buckets 

Downstream effects of the environmental health problems originating on produce farms are huge. The  problems reverberate through the the rest of the controls we have in place. Because the risks are not well controlled, we need more and more robust surveillance, traceability and product recall ability, testing; and of course, redress for victims in court. These unfortunate individuals and their families hold the bag at the end of the system without much control.  The cost burden on the food industry due to outbreaks is remarkable. The Listeria problem in cantaloupe may cost industry $150 million in legal fees, alone. All of this has happened because we have not effectively established in the produce industry a relatively few environmental health protections that should have been there years ago.

Thinking optimistically, we can fix most of the produce contamination problem during growing and harvesting of produce by effective controls over workers; water supplies and usage in all its forms; and wildlife. We can ease the pressure on the supply chain, and minimize the downstream effects on consumers and society at large.

Agriculture has been side by side with animal husbandry and wild animal populations forever, so we cannot expect to remove the zoonotic reservoirs for pathogens completely in farm environments. Therefore, there will always be some risk in fresh produce; but the residual risks passed on in the supply chain will be better managed during packing, processing and handling downstream, if the microbial burden is low.

Vaccination maybe an option to protect against E coli infection in cattle, since we have one with efficacy; but granted, this protection has had poor discussion and vaccines have not been applied. If we had an effective vaccine and farmers would use it, one would start there. Ideally, we would reduce the incidence of pathogenic E coli in cattle (the reservoir) through vaccination, and then move on to exclude the wild animal populations and clean up water sources.

It is likely that adequate fences and other animal barriers, adequate setbacks (still don’t know what this means in every case), water treatment (when needed), strict adherence to personal hygiene, self-inspection and maintenance will solve most of the E. coli and Salmonella problem in growing areas.

We can do this, but a coordinated national efforts is not so simple, and everything has a cost. Somebody must pay, then somebody must make sure it gets done, and financial resources are not necessarily there.

The farms I see would need about $10,000 to $50,000 (could be higher for some) of initial investment, and probably at least 10% of that for yearly maintenance, to implement effective wild animal exclusion measures. The cost would be borne by the farmer in addition to the many other costs of Good Agricultural Practices(GAP), like personal hygiene, training, use of antimicrobials and water treatment, liquid and solid waste controls, that he currently pays for.

Not all farms need the same intensity of controls; I see irrigation water coming out of deep wells as clean as tap water (Total Coliform < 1 cfu), and often the crops see no foliar applications. I see other situations where the foliar application of water is sourced from the surface, and must be treated.

Animal intrusion risks vary widely also; there are some farms in the Southeast where I see only isolated dogs, cats, or bird exposures with an occasional rodent or ground animal.

On some other occasions, I see systematic deer, pig and other wildlife intrusion and extensive droppings. Sometimes we find feces to the extent where harvesting must be halted, and/or production stopped.

In the western US, I see the cattle operations butted right up to produce production; the Salinas Valley in California has much different space requirements, resource needs, and land use issues then Immokalee in the Florida Everglades. As an aside, during our private investigation of the 2006 spinach E coli matter, I sampled one cow patty from a Salinas area hillside pasture and recovered an E. coli: O157:H7 isolate (but not the outbreak strain). One lucky random sample? Or is this bug seriously rampant in this area?

In addition, there are areas with water diversion and flooding problems (due to drought conditions we have not seen much of this factor in outbreaks) and several other environmental health risks we can point out across the board in agriculture.

This is all manageable, and makes it more manageable for us to put into place all of the other safeguards we now need.

On the farm we have “in your face" environmental health problems similar to those that are already addressed by the existing environmental health profession.

We need environmental health professionals to fix environmental health down on the farm, and they can do it, its as simple as that.

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.

http://www.usatoday.com/news/opinion/story/2012-01-24/produce-marketing-association/52780194/1?csp=34news&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+News-Opinion+%28News+-+Opinion%29

Looks like we will not see then end of the Jensen/Frontera/ Primus Auditor issue for some time. While there is plenty of room for criticism of Jensen, Fonterra, and Primus there are also problems with FDA, and this tragic incident has become a hot potato being passed to and fro by congress.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174171.htm

I keep reading FDA’s take on this as if they had an actual law in place that people had to follow, and actual inspectors in the field for enforcement, and an educational arm. FDA still has no muscle on the farm, just a law now on the books that is lagging behind. Until they get thier ACT together, it’s not fair to blame the industry for not getting it together when they themselves cannot.

I am not defending anyone, but if I were, I could look at the 2009 FDA Guidance for melon and wonder where it says that Jensen should have used a chlorinated hydro cooler to cool melons. FDA says it’s safe to use flowing water of satisfactory quality without an antimicrobial to cool melons. Nowhere does it say melons had to be pre-cooled, anywhere. In fact according to FDA, melons can be field packed and placed directly into a cooler. A hydro cooler (this is a refrigerated, circulated water bath, tank or drench that may also contain ice) is recommended, but the flowing water method is allowable, according to the guidance. Any auditor who would read the Melon Guidance of 2009 would have said FDA has no requirement to use an antimicrobial IN SINGLE PASS WASH WATER.

And here we have more from Leavitt and Partners, a DC consulting firm, taking shots at the auditing company from left field and just repeating the double talk while not really understanding what they are saying. But of course, this is business.

This whole discussion is beginning to smell and is turning into a witch hunt and a diversion for the fact that we have next to no currently enforced laws in produce safety. As result, we see systematic failure of the food safety protection they would afford us. And so industry has taken on itself this huge challenge of agricultural food safety and failures are occurring, and will continue. Third party audits are not designed for public health protection, and even if strengthened they will not their place.

And when and how does FDA propose to notify the industry about the minimum requirements under the FSMA? Most folks I speak to don’t have a clue what to do.

This sad scene points not just to failure of audits, but reveals food safety at the primary production level of our food supply has been neglected. It’s going to take decades to educate farmers and to fix the problems spread over millions of acres of land and thousands of farming operations. The failures include FDA not being able to enforce rules or educate the industry, and if I sound like I am repeating myself, I am.

The third party food safety audit system was never intended to stand in the place of regulation. If we as auditors were supposed to enforce FDA Guidance, and now Laws, just how is that supposed to work? There is no mechanism for that.

Where are the thousands of competent people to do this job, the army who understand agriculture and how to do a produce risk assessment, commodity by commodity? How are small producers like the Jensen brothers supposed to cope with the detailed scientific risk assessment he and now thousands like him must by law perform?

This situation has got to be solved by industry and FDA working together, and proper funding and research.

Fix the mess first with regulations and guidance, then maybe there is some justification that Jensen and the rest of us should have known better.

Passing the hot potato is only going to burn more consumers.

http://leavittpartnersblog.com/2012/01/investigation-of-cantaloupe-listeria-outbreak-has-congress-asking-serious-questions-around-third-party-audits/?

The controversy continues over the value of third party audits in food safety at the fresh produce level, as pointed out by Professor Doug Powell at Kansas State University in his BITES blog.

Jim Prevor, produce industry analyst, says changes are needed, while the law firm Marler-Clark is suing a food safety auditor and a third party auditing firm.

The lingering question remains, "how can we improve this system"?

Third party audits are best implemented when there are regulatory controls over the audited operations, thus underpinning them.

In their absence, third party audits are flawed by a lack of standard government requirements such as the preapproval of equipment, structures, layout and design, waste disposal methods and potable water sources.

Third party food safety audits are currently conducted as part of a firm’s overall quality assurance program. The audits are simultaneously  environmental risk assessments, regulatory compliance assessments, evaluations of production processes and analyses of management controls.

Food safety auditors, auditing companies, standard setting and certification bodies, and all players in the produce supply chain share a common interest. These partners should work together through a logical and cooperative approach guided by the best available science, to protect public health, and in so doing, their own interests.

Suggestions for improving the third party food safety auditing processes include:

Changing the roles of the Audit Company, Buyer, and Customer:

Currently, buyers (retailers, middlemen, brokers, marketing groups) require that suppliers schedule and pay for an audit with an auditor or auditing company. Since the auditee makes such arrangements, they are the customers of the audit firm. The auditor is beholden to the “customer” to establish the time and location of the audit in advance. The auditee also negotiates the price, and can even request a particular auditor, although the final decision as to which auditor to assign in generally left to the auditing firm.

If roles are reversed, and the “buyer” becomes the “customer”, then the buyer would schedule the audit, and the buyer would pay for the auditing firm for the audit. The buyer would then receive the audit report directly and have control over its dissemination.  Most importantly, this process would allow for an unannounced audit to occur. Auditing firms know that scores of announced audits are often much lower that announced ones, suggesting observational bias that this method might filter out.

The Buyer, as the Customer, would become the driving force behind audits, their timing, stringency, frequency and interpretation.

Fee arrangements and the practical aspects of doing business may pose hurdles to this approach, but the resulting value to buyers may make this method attractive enough to induce changes in the current business models.

Roles of government and auditing firm:

The Food Safety Modernization Act (FSMA) currently addresses the need for auditor competency when working in post-harvest operations under federal jurisdiction and as part of FDA’s “Foreign Supplier Verification Program”. Auditing companies should require that auditors become fully familiar with existing FDA produce safety guidance and the new requirements of the FSMA, especially the requirements for a hazard analysis and science-based controls.

The FDA should begin an effort to meet with buyers and auditing company executives to discuss partnerships, and establish liaison with them to coordinate their activities around meeting the goals of the FSMA.

The FDA should protect auditors under whistle blower protection provisions and require that the Buyers (as the drivers of the model) provide to them all third party documents related to food safety within 10 days. The third party risk assessment findings should drive the need for FDA to conduct its own rapid response risk assessment within 30 days, if and when necessary to protect public health.

Auditing companies should report “automatic failures” resulting from adulteration to FDA  within 24 hours.

Transparent communications should happen between the FDA, auditing firms and buyers. FDA should make known its own compliance records in a timely fashion. Third parties should not audit any facility operating under FDA sanctions until such firms are in substantial compliance.

When third party audit criteria are less stringent than federal rules, their value as a risk assessment tool is negated.  Risk assessments, especially newly adopted ones such as Global GAP- should be scrutinized. Currently, the failure to have toilets available to field workers in Global GAP would not trigger an automatic failure, this standard also allows hand gel to replace hand washing, such unsanitary practices are not acceptable under the FSMA.

Reassessments by buyers and auditing firms

A buyer should be required to perform a reassessment either through a third party auditing firm or through its own (2nd party) audit, in any operation where corrective actions must be verified.

The following should trigger a reassessment audit;

  1. A Critical Control Point failure in a Hazard Analysis Critical Control Point (HACCP) based system.
  2. An automatic failure of the audit. 
  3. Laboratory or others test indicating a microbial, chemical or physical hazard exists in a facility, product or process. 
  4. Significant noncompliance with FDA rules (when published).
  5. Significant repeated failures of the food safety management system.

Expanded role of microanalysis

Because auditors have access to a supplier’s micro-testing results, they can base risk assessments on the findings. Expanded micro-testing will allow auditors to make better judgments concerning the microbiological quality of products, equipment, and water used in a wide variety of processes and environments.

The government and science community, including researchers, academicians, and practitioners should work together to enable a more accurate microbial risk assessment.

The future of third party audits

In the short-term, there is no viable substitute for third party risk assessments in fresh produce operations. Buyers are not prepared to audit the many suppliers they have by themsleves, and government bodies are not adequately funded to begin the process of regulating the full multitude of suppliers, domestic and international.

In the long-term, an effective FDA would reduce the need for constant oversight by third parties, but this does not appear to be a certainty given the political and economic picture as it appears today.

Self-audits (internal audits or 1st party audits) are much underutilized. Supplier “self-reporting” directly to buyers could provide data so that audit frequencies could be adjusted using a risk-based approach.

The best alternatives to improve produce safety through third party audits may include:

  • ·         Buyer financing and coordination of the audit
  •        Unannounced audits
  • ·         FDA involvement in the third party audit process including determining auditor competency, training  and oversight
  •        Risk based frequencies for audits based on self-reporting
  • ·         Transparency of all audit and inspection findings by all concerned
  • ·         Validated physical, chemical and microbial standards
  • ·         Expanded use of 1st and 2nd party audits

The noted microbiologist Mansour Samadpour has recently suggested to Bloomberg’s Stephanie Armour that (See Bill Marler’s blog) 

“You can make these audits useful by writing them on toilet paper. Then someone would at least use them,” said Mansour Samadpour, president of Lake Forest Park, Washington-based IEH Laboratories and Consulting Group, a food-safety consulting firm, in an interview. “They’re worthless. They give a false sense of security.”

 

http://www.marlerblog.com/legal-cases/the-best-quote-ever/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+MarlerBlog+(Marler+Blog

 

Are third party audits currently useless to buyers and to the supplier who pays for them?

 

I think we need to clarify how the buyers can best use these reports, and how to improve the reporting process rather than throwing stones at one another…no one is shatterproof.

 

Understand that assuring food safety in the fresh produce supply chain is very different in many ways from assuring the safety of the meat, poultry, dairy or other food industries, most of which are highly regulated.

 

Currently, there are some alternatives to the independent third party risk assessment on farms, but those solutions are a ways off. Some state regulators are focusing in on the agricultural sector, but today the regulation and enforcement of food safety standards is left to the industry.

 

The “food safety industry” is quite competitive and diverse; private labs compete for market share against auditing firms with labs, auditing firms compete with other auditing firms, standard setting and certification bodies compete, pest control services also compete with chemical suppliers who also own auditing firms.

 

Therefore, understanding what is being said by firms like IEH Laboratories and Consulting Group about its competitors requires some retrospection.

 

The testing of agricultural products for safety by labs today is not routine. However, as this trend grows we may eventually see a produce firm that "has passed a Lab test" involved in an outbreak just as we have seen raw meat facilities that have passed government inspection and laboratory analysis involved.

 

I would like to ask Mr. Mansour if he would be just as critical of labs for giving a "false sense of security" when the products they test cause outbreaks? Is USDA inspection worthless if inspected products cause outbreaks?

 

It is clear to me that third party audits are needed in the absence of any other outside controls of primary producers at this time. The produce industry, together with the food safety industry that supports it, should consider the following soft spots in this process: 

  • Audits are routinely announced, meaning that the time of the audit is known ahead of time by all parties. An auditing firm that conducts both announced and unannounced audits reports that the differences in the score between the two measures can be 10 percentage points or more. Risk based inspections do not necessarily require unannounced visits as the risk in a process can usually be determined from operations, but at least some announced audits are a good idea. 
  • Buyers currently are empowered by their customers to go outside the recognized certified sellers if product is needed. The pool of unregulated and unsupervised facilities is still large. It is not uncommon to have an audited, certified and even inspected produce operation, operating beside an unregulated unaudited firm. Inconsistencies like that cause animosity and dysfunction.  

·         The pressure on buyers, especially brokers and other middlemen to buy from anyone, results in placing some operations in a competitive disadvantage. There is no clear answer to this as some operations just simply ignore the requirements that others must follow and can still sell their products. 

  • The standards the third parties use are written by the buyers. These are also the entities that evaluate the findings, and make buying decisions supposedly based on conformance to their standard. Buyers cannot raise the bar so high as to eliminate a large share of the supply chain and thus develop those standards so as to be inclusive of the current levels of sanitation and safety in the industry- which can be less than perfect. I have not seen yet where a low score on an audit has caused an operation to go out of business. An outbreak will do this, but not a low or even failing score. In today’s market, if the supplier has needed product, the volume and the physical quality, he will be able to sell it to a customer somewhere with our without a passing grade, even with or without an audit of any type. 
  • Retailers and their own culture effect food safety audit systems in produce.

I was in a well-known market the other day and saw next to the open bin of cracked and otherwise damaged mixed tree nuts (with no traceability), bags of packed nuts, clean and unbroken with source codes. The bagged nuts were about 50% more expensive.

Rather than using audit reports for toilet paper, buyers should instead be using them to make decisions and all involved in the private assurance of produce food safety systems should read the writing on their own wall.