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Pundit’s Mailbag — Does A 1,200-item Audit Necessarily Result In More Safety Than A 40-item Audit?

The always thoughtful Bob Sanderson has frequently contributed to the Pundit, including these pieces:

Pundit’s Mailbag — The Acceptance Of Risk

Pundit’s Mailbag — Sprout Lessons Echo Food Safety Dilemma

Pundit’s Mailbag — More On Manure

Pundit’s Mailbag — The Tyranny Of Economics And The Goals Of Fairtrade

Pundit’s Mailbag — Can Irradiation Follow The Path Of Pasteurization?

Pundit’s Mailbag — A Look At Organic Versus Conventional Yields

Pundit’s Mailbag — Irradiation, Pasteurization and Labeling

Pundit’s Mailbag — Pesticides And Cancer

Pundit’s Mailbag — Food Prices And Free Markets

Pundit’s Mailbag — Organics And Manure

Testing Sprout Seeds

Now he asks a question that strikes at the heart of industry efforts to improve food safety… and which applies to the current debate over exempting small growers from proposed food safety standards, an issue we discussed in our piece, FDA’s Michael Taylor Preaches ‘Scale Appropriate’ Food Safety Standards, Code Words For Exempting Small Farmers And Organics:

I’ve been following the discussion about the problem of “local” in its relationship to food safety standards. I think you’ve taken the position that, even if you would like small farms to be viable, it doesn’t seem quite right that they should be exempt from the safety standards that are required of large producers.

An underlying question is whether an expensive, increasingly detailed audit has the effect of reducing risk more than a simpler, more inexpensive audit.

One thing which is not in question is that an expensive, detailed audit will require an individual, if not a whole department, to handle the documentation required in the audit. So right off the bat, any company that does not have the resources to keep that person or department on the payroll does not qualify for certification in that auditing program. This means essentially that if these audits are a prerequisite for selling to retailers, then only big companies will have a chance of qualifying.

If there is any value in supporting small food businesses, it is critically important to demonstrate that the increasingly expensive and detailed audits will result in quantitatively safer products.

In other words, does a 1,200-item audit necessarily result in more safety than a, say, 40-item audit, or does it mainly just disqualify producers who can’t afford full-time QA staff?

For your information, having looked at two of the big audits, I can say that neither one of them addresses the key components of sprout safety.

— Bob Sanderson
Jonathans Sprouts

Rochester, Massachusetts

Bob raises an interesting point, and it is a different point from those that are often discussed in relation to audits.

One big complaint on audits is that multiple expensive audits are a burden without increasing food safety. David Gombas, PH.D., Senior Vice President, Food Safety & Technology for the United Fresh Produce Association, spoke to this issue in Pundit sister publication, PRODUCE BUSINESS, to update the industry on the effort to harmonize the audits, and you can see that piece here.

In our piece, How to Improve Safety: Aggrandizing the FDA Only Distracts from Real Solutions, written for The New Atlantis,we dealt with the problem of corruption in many parts of the world when it comes to audits and certifications. You can read the piece right here.

Bob is, however, posing a different question: Do large audits lead to safer food than smaller audits?

It is a very interesting question and one for which we are not aware of any actual research. (Of course we are not aware of any research that shows that audits of any type produce safer food.)

It is very hard to imagine how one could do studies on these things. Simply comparing food safety records of audited and un-audited firms would not suffice, as they self-select and would show biases either way. Yet we couldn’t do a random assignment either because customers, government, etc., have different requirements.

So we have no real knowledge on this subject and not much likelihood of getting such knowledge. Yet it is a crucial question as we confront the intersection of a more rigorous food safety regime with the realities of small growers.

The current options are undesirable. On the one side, we have the mainstream industry and most of the food safety experts who point out that pathogens are equal-opportunity problems and that the same rigor in testing and monitoring water, soil amendments, compost, personnel and their equipment and animals, both wild and domestic, must be applied at every farm. If there are differences, they are based on real world factors — say proximity to a dairy farm — not based on size.

This is clearly the consensus of science today. An unintended consequence, though, may be that food safety protocols are more of a burden than many small producers can bear.

The most popular alternative is to exempt small growers from the food safety requirements. That may, in fact, save them from the burdens of compliance — but it does nothing at all to improve food safety. It also will have the unintended consequence of keeping small growers permanently outside the mainstream of the industry. Surely many buyers will refuse to purchase “exempt” product. Small growers won’t be able to grow with their customers to become bigger growers. In effect, the industry will be bifurcated and small growers publicly stigmatized as operating under a lower regulatory standard.

The answer, if we are to find one, has to be a third way. Perhaps we can co-op a food safety organization or find a way to test, say, river water and apply that test to many nearby farms. Of course, Bob Sanderson is saying that if we could simplify the audits and focus on the essential attributes that contribute to food safety, we could make the whole audit process more feasible for small producers.

Without any hard evidence, we would be willing to state that this is at least theoretically possible. There is a tremendous inclination to audit and test for what is easily auditable and testable — whether that is important or not. There is an inclination among all parties to show how thorough they are when it comes to audits. And we suspect that initiatives such as the harmonization one Dr. Gombas wrote about will make things more complex in this regard. If audit one checks for red and audit two checks for blue, the obvious route to harmonization is to check for both red and blue. So the effort to make companies undergo just one harmonized audit almost certainly guarantees a larger audit.

So, if we cut out the superfluous fluff, we should be able to do a more focused audit that would be cheaper and easier and do just as much to further food safety. It is a great idea, but a very difficult one to implement.

How do we get the kind of specific expertise in every crop, every growing region, every season, to know what is crucial to food safety? How do we train auditors to be so specific? How many buyers could evaluate or appreciate such a report?

On an issue of this complexity, we felt the need to bring in an expert, so we asked Dr. Robert Stovicek, President of, for his thoughts on the subject:

Thanks for giving us an opportunity to respond to the writer’s concerns. I’ll limit my response to audits dealing with safe production and handling practices for fresh produce suppliers. I should also add up front that 20,000 ppm free-chlorine exemption granted sprout operations speaks volumes regarding the challenge that this commodity presents.

Around 1999, at least one auditing firm serving the fresh produce industry attempted to distinguish itself by developing what we felt was an excessively detailed audit. This audit failed to gain traction in the marketplace because retail and foodservice firms found it to be overly complex.

At the other extreme, audits can and have been made extremely brief, but the trade off is the auditor is given more leeway and the auditee has less understanding of what is expected. The assumption is that the auditor is a master auditor, an individual who will probe into general areas of concern. As you can imagine, cost and performance variations from auditor to auditor are hard to control under this scenario.

Participants in United’s Harmonization Project have consistently indicated that over 90% of the audit content is identical. It appears that the market has successfully eliminated audits that exist on the extremes.

When Primus first ventured into the auditing business, we assumed that the greatest value to the producers and the buyers was effective communication. Suppliers needed to understand what was expected, and buyers needed to understand who was, or who was not, executing.

From the beginning, it was understood that providing a service to small operations would be a challenge. To address the expectation issue, Primus posted audits, guidelines, self-audit programs, rudimentary tools for developing draft operating documents, etc., on the internet. We also recognized that in addition to the cost of the audit, the cost of travel, meals and lodging was going to be prohibitive for small operations.

To address these concerns, Primus has developed a wide network of qualified and trained auditors across the Americas, thereby cutting down the overhead expense associated with auditing. The overheads of running a certification company with audit development, administration, certification and quality control, are still inherent in the fee structure. In order to further increase the use of our templates and yet remove the fees noted in the last sentence, we created a system where auditees can contract directly with local auditors and utilize the Primus auditing system.

Hiring a local auditor should eliminate travel expenses and other costs. In numerous cases, auditors have for years been contracting directly with suppliers conducting the audits and submitting them into the Primus system. The only fee Primus charges in situations like these is a submission fee of $25 and a transfer fee of $15. The contracted price between the auditor and the auditee is negotiated at prevailing local rates, or at least, it should be.

Small growers or fresh produce operators who are resourceful enough to survive find ways of collaborating with neighbors and/or form cooperatives. They share equipment, expertise and other resources. The neighbor that is a master welder may provide his or her services in exchange for time or materials from his neighbor. The same will happen with the neighbor that has access to the Internet and a skill for research and writing. Small growers that insist on not collaborating with their neighbors are certainly making success more difficult than necessary.

Measuring the success of auditing programs is inherently difficult. We all know when the systems fail, but measuring success is far more complicated. If a crisis does not occur, what part did the audit contribute to the avoidance? Proving a negative is normally an exercise in futility. On a macro level, measuring the effectiveness of the auditing efforts is further frustrated by the increased funding in government organizations assigned the job of detecting foodborne outbreaks and incidences.

The additional staffing and funding, along with improved technologies, make the industry’s success at addressing safe food production and handling a difficult message. This goes to the heart of the debate over whether fresh produce is dealing with an emerging issue or an age-old issue just now revealed by new, less costly technologies.

For those of us that have been in this business long enough to exchange notes on the improved conditions that currently exist at the fields, coolers, packing houses and the processing operations, we harbor no doubts about our success. Fresh produce destined for American consumers has never been grown or handled under more sanitary conditions.

Many an auditor recognizes that his or her observations (e.g., uncovered glass, miss-measured free-chlorine levels, etc.) and the subsequent actions taken by the producer prevent consumer pain and suffering. For many, the understanding that their effort prevented a problem is measure enough of success.

At a different level, we do gain a sense of success when we complete a deposition and explain the level of effort our clients have gone through to assure the safety of their product. There is certainly a degree of satisfaction knowing that the confirmation work Primus provided contributed to minimizing our clients’ or supporters’ potential liability. Recognizing responsibility regarding damages is one thing; it is a completely different thing to pay punitive damages when you know that your efforts as a producer exceed or match your competitors and exceed the average consumers’ expectations. It is satisfying to know that clients who have been through the harrowing experience of a deposition relied in part on materials generated by Primus and will never willingly enter future situations without independently derived confirmation of their efforts.

On a more positive note, it is always gratifying to listen to a client concede that documentation led to more questions from a prospective client and to recognize the modest role Primus played in assisting a client in landing new business. And, of course, it is always gratifying to provide enough information for a diligent and well informed buyer to separate the real performers from the talkers.

Multi-tiered food safety efforts are commonly developed based on the hazard analysis for a given commodity or its typical handling. Commodities that are universally cooked prior to serving provide a kill step that may not require the same level of scrutiny for microbial concerns but they will still experience an equal level of scrutiny for physical and chemical contaminates. The US legal system holds the answer to whether there can be a “size appropriate” safety system. Realists understand that the answer for the private sector to “size appropriate” safety systems is “no”.

Safety is the non-negotiable factor. I cannot imagine a legal department advising any major buyer in the United States to establish a two-tiered or multi-tiered food safety program based on size. Being on the wrong side of that deposition, explaining why weaker safety expectations were formalized and institutionalized at the corporate level for a major American food-service or grocery retailer sounds like an invitation to a massive settlement for punitive damages.

That being said, auditing firms that creatively find ways of lowering the costs of auditing while retaining the credibility of the process will survive. Small growers that collaborate with their neighbors, form cooperatives, choose aggregators that bring more to the table than sales expertise, will find a way to answer the market’s demands. Confirmation of safe growing and handling practices is now part of the market decision-making process and it is not going away.

— Robert Stovicek
Santa Maria, California

Many things that are theoretically possible are, practically, impossible. We thought this line from Dr. Stovicek’s letter particularly pregnant with truth:

“…audits can and have been made extremely brief, but the trade off is the auditor is given more leeway and the auditee has less understanding of what is expected. The assumption is that the auditor is a master auditor, an individual who will probe into general areas of concern. As you can imagine, cost and performance variations from auditor to auditor are hard to control under this scenario.”

In other words, the answer to Bob Sanderson’s question is theoretically yes… if you could have only great master auditors doing audits, people astute enough to catch a specific concern out of a general question and then delve deep. But, practically, the answer to Bob Sanderson’s question is no… because we can’t assume that every auditor is a master.

Dr. Stovicek does offer hope though. We highlighted in an early piece the efforts Primus makes available for small growers and with the use of these methods and a willingness to work cooperatively with neighbors, it may be possible to keep costs within a viable range, especially when one considers the enormous cost of operating outside the food safety system.

It may seem to small growers that getting an exemption is a big win, but in actuality it will stigmatize them as sub-standard operators. The cost of that stigma will be substantial, even if less specified, than the cost of implementing food safety systems.

Many thanks to Bob Sanderson of Jonathan’s Organic for initiating the conversation about food safety audits and to Dr. Robert F. Stovicek and the people at for helping us wrestle with this important issue.

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