William Neuman over at The New York Times, who we recently spoke to regarding the lawsuit filed against the FDA in the Del Monte Fresh cantaloupe imbroglio, now is, of course, writing about the Jensen Farms cantaloupe issue. The article, titled Listeria Outbreak Traced to Cantaloupe Packing Shed, has caught the attention of the trade:
Jensen Farms hired an auditor called PrimusLabs, based in California, to inspect its facility. Primus gave the job to a subcontractor, Bio Food Safety, which is based in Texas. Jensen and Primus declined to provide a copy of the audit report.
Robert Stovicek, the president of PrimusLabs, said his company had reviewed the audit and found no problems in how it was conducted or in the auditor’s conclusions.
“We thought he did a pretty good job,” Mr. Stovicek said. He said the auditor, James M. DiIorio, has been doing audits for the company since March.
He said that Mr. DiIorio had received two one-week training courses as part of his preparation and had also gone on audits with other auditors.
Asked how Mr. DiIorio could have given high marks to a facility that the F.D.A. described as a breeding ground for listeria, Mr. Stovicek said, “There’s lots of variations as to how people interpret unsanitary conditions.”
Mr. DiIorio did not return phone calls seeking comment.
Trevor V. Suslow, a professor of food safety at the University of California, Davis, said auditors may give farmers, processors and retailers a false sense of security. “There needs to be training, certification and auditing of the auditors,” he said.
This raises many issues. After all, we don’t think there is a person in the whole FDA who knows more about auditing than the auditors. While some UK retailers have expertise here, not many US retailers do. So who is going to train whom in what is unclear. In any case, shortly after the article was published, we received the following letter:
Per the excerpt from The New York Times article above, Jensen Farms hired Primus to audit its food safety practices, and the company was found by an auditor that Primus subcontracted the audit to, to be in compliance with their standards.
What does this say about Primus, and about the idea of sub-contracting this function? I guess there are audits, and then there are “audits”!
— David N Cook
Deardorff Family Farms
Your piece, Pundit’s Mailbag — Can Tomatoes On The Vine From Mexico Be Sold?, is as good an explanation of how the FDA works in these cases as I have heard.
However, I would take issue with one word you use in the piece, I’ve capitalized it below:
“So the reason the government KNOWS it is tomatoes…”
Given that the FDA admits it has found no tainted tomatoes and now states that it probably never will find the true source of this outbreak (LA Times Fri Jun 13 buried on page C2), how can they say that they KNOW anything?.
The FDA should be honest and say they ASSUME or SUSPECT that tomatoes are the culprit and go from there.
Thanks for your great work on this issue.
— David N Cook
Deardorff Family Farms
David, of course, turned out to be 100% correct. The FDA turned out to be wrong.
Now, he weighs in again and raises more issues to think about.
On the issue of contracting out the audits, two thoughts come to mind:
First, it is not clear that how the auditor gets paid is the key here. If instead of paying him on a per audit basis, he was on salary. Would James M. DiIorio have turned in a different audit?
It is not an unreasonable question. After all, people with their own business whose income is dependent on getting assignments might be hesitant to be really tough on an audit for fear they won’t be given assignments again. In this case, there is no evidence of that. And such an issue would apply to employees as well. They might fear losing their job if the customers start complaining.
In this specific case, the key issue of the lack of an antimicrobial in the one-pass or non-recirculating wash system, was carefully noted on the audit report. The auditor noted it but didn’t detract points because of an assessment, as we mentioned here, that in a non-recirculating water system neither the FDA guidelines nor standard industry practice requires an anti-microbial be added to the water.
There is a question here of how divergences between industry standard practices and best practices should be handled. But there is little evidence that this auditor did a bad job, and there is no evidence at all that if he was on payroll, as opposed to a contractor, the outcome would have been different.
We actually hear that some of the best auditors become contractors because they can can make more money than as a salaried employee of any of the auditing companies. So some of these contractors are among the best auditors out there.
Second, many years ago we asked Primus what they could do to help small and regional growers improve themselves, and the contracting program was part of that effort which we profiled here. It was an effort to reduce the costs of audits.
But it was not mandatory then and is not mandatory now. This is where buyers have to get involved. Wal-Mart is well aware that contractors are being used. All Wal-Mart has to do is issue a specification that it will only accept audits done by full time employees of auditing companies and it will get exactly that.
The downside is cost: In many cases the contractors are spread out and a decision to use only employees for audits will often involve an extra travel day to and fro. That roughly triples the cost of the audit. Add in the plane, hotel room, food and the fact that you probably have to pay auditors more of you want them to consistently travel, and the actual out-of-pocket audit cost might increase four or five times.
Wal-Mart hasn’t perceived an upside in food safety sufficient to justify this cost or Wal-Mart would have required that auditors all be employees. We can’t say we see this either.
Third, the auditor is important but, assuming competency, the crucial issue is the standard. Auditors don’t get to walk through a tomato field and take away points because they think it would be safer if the tomatoes were grown in a greenhouse. There is no FDA guidance to that effect; it is not industry standard, etc. There needs to be a standard against which things are audited.
There are lots of public standards — the British Retail Consortium, SQF, etc. — or as with Marks & Spencer in the UK, a buyer can create its own standards.
In this case, despite its avowed commitment to GFSI, Wal-Mart did not require a Primus GFSI audit — only a standard Good Manufacturing Practices audit was used. The very fact that two separate things exist implies that one will audit for things the other will not.
Although it should also be noted that even if Wal-Mart had a GFSI audit, it is not clear it would have made a difference. The thrust of these audits is not pass or fail; it is improvement. So the GFSI audit might have revealed more things for Jensen Farms to work on, but unless Wal-Mart is carefully reading these audit reports and has established standards for when it will stop buying, it is not clear that if the FDA report had been transcribed word for word by the Primus auditor and added as an addendum to his audit, this would have caused Wal-Mart to stop buying.
There are, of course, audits and then there are “audits,” as David Cook says, but Wal-Mart gets exactly what it wants and what it is willing to pay for.
If Wal-Mart wanted a GFSI audit performed by a full time Primus employee, the company would specify it. If Wal-Mart wanted specific standards for its product that are not yet in the FDA advisories or standard practice — say that all wash systems, one pass or recirculating, must use antimicrobials or that all cantaloupes must be dry harvested or that all cantaloupes must be pre-cooled — then the company would specify it and get it.
That Wal-Mart didn’t specify any of this hardly seems like something to hold an auditor responsible for.
Many thanks to David Cook for his thoughtful letter.