Food Safety Conundrum: Third-Party Audits

In its role of supplementing government inspections, third-party food safety audits of farms and food processors are supposed to serve as a defense against outbreaks of foodborne illness. And they often do. But when they don’t, the results can be catastrophic, raising questions about how the food safety auditing system should be improved.

The latest example of an audit that allegedly failed to flag unsanitary conditions linked to an outbreak occurred last year at Jensen Farms, Granada, Colo. PrimusLabs, Santa Maria, Calif., through its subcontractor Bio Food Safety, conducted an audit at the farm’s cantaloupe packing shed in late July, days before the start of a listeria outbreak that the Food and Drug Administration tied to conditions in the shed. Yet the auditor gave the packing plant a score of 96 points out of 100, according to a report in the New York Times. Robert Stovicek, president of PrimusLabs, declined to comment for this article.

As of the beginning of February, the death toll attributed to the infected cantaloupes stood at 32, out of nearly 150 illnesses, making it the deadliest foodborne illness outbreak in the U.S. in nearly 100 years, according to Food Safety News.

Third-party audits have also come under scrutiny in several other high-profile outbreaks in recent years. For example, in 2010, a salmonella outbreak was traced to filthy conditions at two Iowa farms where hundreds of millions of eggs were recalled, though one of the farms, Wright County Egg, had received a superior rating from auditor AIB International, Manhattan, Kan., according to numerous reports.

In late 2008, AIB International also gave a superior rating to facilities operated by the Peanut Corp. of America (PCA), which were later found to be unsanitary and linked to at least nine deaths and nearly 700 illnesses.

In 2009, a spokesman for AIB told SN that its approach to auditing PCA “involved checking documents, making sure programs are in place, checking equipment at a single point in time.”

Bill Marler, an attorney with Marler Clark, Seattle, is among the sternest critics of the food safety auditing system. “Time and again this firm has represented injured people, or the families of those who died, in outbreaks where a negligent processor was given glowing reviews, only for investigating agencies later to find during unbiased, competent investigations done without the veneer of conflicting interests, that the facility in which the food was produced was not suitable for the production of [animal feed], much less food for human consumption,” he recently wrote on his online blog.

Craig Wilson, vice president of quality assurance and food safety, Costco Wholesale, takes issue with the refusal of auditing companies to offer an insurance policy on their audits in case of a recall or failure. “When there’s a failure, they will say, ‘We’re not accountable for when we’re not there,’” he said. “But they’ll say, ‘It was fine when we were there.’ It’s an interesting conundrum.”

Some critics believe there should be greater federal oversight of auditing companies. The Food Safety Modernization Act, passed a year ago, expanded the role third-party auditors can play in authorizing the safety of some imported foods, but it does not address regulating private auditors.

But Amanda Hitt, director of the Food Integrity Campaign for the Government Accountability Project, a nonprofit watchdog group, does not believe the federal government should shift responsibility for food safety to private auditors.

“People confuse the role of audits,” she said. “People think it’s the same as a federal inspection but it’s not. It’s the government that has a public health mandate.”

Even if federal inspections are done once every five years, they represent a “threat” to companies that cut corners on food safety.

Private audits, Hitt added, are only as strict as the company being audited or its customer wants them to be. “If [a supplier] wants to get into McDonald’s, they have to bring a high-quality audit,” she said.

Most audits, however, are based on standard industry practices, not best practices, noted Jim Prevor, who writes the widely read Perishable Pundit blog. If all audits are conducted at the higher standard, “will it really be acceptable to flunk 80% of the nation’s facilities on these audits, especially if the operators will never be able to meet the new standards?” he wrote in a recent post.

SQF Standard

Still, the food industry has tried to address the weaknesses of third-party audits by developing a more rigorous standard through what is called the Global Food Safety Initiative (GFSI). One of the organizations affiliated with the GFSI is the Safe Quality Food (SQF) Institute, a division of the Food Marketing Institute, Arlington, Va., which certifies third-party auditing firms and auditors that meets its requirements.

PrimusLabs, which oversaw the Jensen Farms audit, does not do SQF audits, said Hilary Thesmar, FMI’s vice president of food safety programs. However, PrimusGFS, one of Primus Labs’ auditing services, was recognized against the fifth edition of the GFSI guidance document, and was in the process of being benchmarked against the 6th edition, according to the GFSI website. Primus’ audit of Jensen Farms was done under its less demanding Good Manufacturing Practices Audit, according to the Perishables Pundit blog.

Jensen Farms “would not have passed an SQF-certified audit,” said Thesmar. “According to the FDA’s assessment, there were multiple problems at their packing facility, basic sanitation problems that the SQF program would have prevented.”

SQF-approved audits require farms or food processors/manufacturers to implement controls such as HACCP (Hazard Analysis & Critical Control Points) “that identify what could go wrong,” Thesmar noted. “It’s strong on prevention, looking for any chance of contamination along the flow of product.”

SQF’s focus on prevention parallels requirements established under the Food Safety Modernization Act. Starting in mid-2012, companies will be asked to put down in writing a comprehensive food safety plan that looks at hazards and preventive controls in their facilities. “Inspections are not as good as analyzing your operation and identifying where hazards could occur,” said Christine Bruhn, a specialist at the University of California at Davis, who does research on consumers and food safety.

Wegmans Food Markets, Rochester, N.Y., finds GFSI-endorsed audits of its private-label suppliers, such as SQF, “really credible,” said Gillian Kelleher, vice president of food safety and quality assurance. “There are checks and balances in the system, with oversight from different players,” she said. Eight-five percent of Wegmans-brand suppliers are certified via one of the GFSI standards, as are the chain’s own production facilities.

“It is paramount that you partner with suppliers that have similar values to yourself,” she said. “We expect [private-label] manufacturers to come to the table with GFSI certification or be actively working towards it.” Wegmans does not currently look for GFSI certification from CPG brands supplying their own products.

On the produce side, Wegmans is helping to educate growers on food safety practices, working with FDA-supported Produce Safety Alliance, which provides on-farm food safety knowledge to fresh fruit and vegetable farmers, packers, regulatory personnel and others. “We bring in USDA auditors to educate how they conduct audits and we bring in certified-GAP [good agricultural practices] suppliers so they can share their knowledge and experience,” said Kelleher.

Costco’s Addendum

Known for its scrupulous food safety practices, Costco Wholesale, Issaquah, Wash., makes greater demands on third-party auditing companies than many companies, noted VP of food safety Wilson. In addition to using its own employees as auditors, Costco accepts audits from certain approved auditing companies, “but along with what they do, they also have to apply Costco’s addendum to all of their audits,” he said.

Costco’s “addendum” covers activities that are “not important” to many auditing companies, such as microbial sampling, Wilson said. The club chain’s food safety requirements also include an “ingredient responsibility program” whereby each of its suppliers needs to demonstrate that “they treat their vendors the same way we treat them,” he said. For example, “I want them to know everything there is to know about the paprika they put on top of their mashed potatoes.”

In the case of the cantaloupe-listeria outbreak, Costco did not receive any product from Jensen Farms, Wilson said. But Costco’s reaction was to put all cantaloupes in a “test and hold” program, which is applied to meat and other produce items, whereby suppliers can’t ship the product until Costco has the results of a microbial test. Costco launched the cantaloupe program last year, and all cantaloupe suppliers were on board by Feb. 1.

Costco’s audits apply to both branded and private-label products. They are both announced in advance and unannounced, though the chain plans to increase the frequency of unannounced audits, Wilson said.

Costco’s auditing standards apply equally to SQF-certified audits. Moreover, the company does not require an SQF audits if a vendor can’t afford it. “You’ve got small vendors that are still great food manufacturers, providing high-quality, safe food but can’t afford the cost of that kind of certification,” Wilson said.

Costco tries to limit the cost of audits to vendors, sometimes paying for them. He does not believe, under Costco’s system, that audits may be compromised if they are paid by the vendor being audited, as some critics have suggested. Auditing companies send the results of audits to Costco and the vendor at the same time. “We don’t communicate with the vendor; we communicate with the auditing company,” he said. “I’m comfortable that the auditing companies are being 100% straight. And if they’re cheating, we’ll catch them.”

Despite the apparent failures of third-party audits in the Jensen Farms, PCA and other cases, FMI’s Thesmar believes that audits go well in “99.999%” of cases. “We have no idea how many problems have been caught,” she said. “They’ve been wrong a few times, but we don’t want to throw the baby out with the bathwater.”

FSMA So Far

Since the Food Safety Modernization Act was enacted in January 2011, the Food and Drug Administration has taken numerous steps to implement it.

Here are some highlights:

• Issued interim final rules on “administrative detention” of foods and used this authority three times.

• Issued interim final rules on prior notice of imported foods.

• Issued guidance to the seafood industry on food safety hazards and to the dietary supplement industry regarding new dietary supplements.

• Received input in developing the proposed preventive control rules.

• Established the Produce Safety Alliance and the Food Safety Preventive Controls Alliance.

• Met the mandate for foreign inspections and is on its way to meeting the five-year inspection frequency mandate for high-risk domestic food facilities.