Maybe it was a poor choice of words, but it was an honest expression from top field management of the U.S. Food and Drug Administration (FDA).
Barbara Cassens, FDA’s district director in San Francisco, was asked about accreditation for third-party auditors while participating in a panel at a recent Produce Marketing Association gathering.
According to a report by The Packer, which covers produce and was on scene, Cassens responded by saying: “We are leaning in that direction. Working out that program is a matter of understanding what principles apply, and how we audit the auditors. The fundamental question is, does it provide another level of safety? If it doesn’t, it’s not time well spent.”
The poor choice of words comes because, as Cassens must know, FDA no longer has much choice in this matter. The Food Safety Modernization Act pretty well mandates what FDA must do.
Food industry lawyers Kenneth Odza and Lee N. Smith of the West’s law firm of Stoel Rives LLP sliced and diced what’s required by the FSMA at a January seminar.
They said within 18 months, FDA “shall” provide for the expedited review and importation of food for importers who participate voluntarily. Section 302 says that “will require” third party certification.
An “importer,” according to the Stoel Rives experts, is any person to brings food, or causes food to be brought, from a foreign country in the “customs territory” of the United States.
Section 302 then says FDA “may require” third party certification as a condition of import. It “can create a system of accreditation of auditors” and “may be” funded through fees imposed on auditors.
Confused? Maybe we need to back up.
Third-party auditors are nothing new to the food industry. Baseball season is almost here, so think of third-party auditors as sort of a backstop for the state and federal regulatory system we rely on to ensure food safety.
Large manufacturers often want to collect regular information on what’s going on with their downstream processors. As a condition of buying product from those processors, they demand regular third-party audits.
In other words, third party auditors have been creatures of the private sector, maybe improving the chances that a food processor will pass that next FDA inspection.
Trouble is, often the only time the public hears about third party audits is when a company in trouble—like during an outbreak—and claims it just went through a third-party audit and passed with flying colors.
Peanut Corporation of America, for example, got a “superior” rating from a third party auditor just before its Salmonella-contaminated product killed nine in a nationwide outbreak that made more than 700 people ill. Flying colors also went to Wright County Egg right before the largest recall of table eggs in U.S. history.
Since the President signed the FSMA into law, Michael Taylor, FDA’s deputy commissioner for food, has been talking about certification of third-party auditors who will have roles for both imported and domestic products.
The terminology itself gets a little twisted. In 2009, FDA went through the motions of putting together a voluntary program that called for a “certification” body that would actually be responsible for “accreditation” of third party auditors.
“But accreditation is sometimes used instead of certification in some parts of the world,” the Dubai Municipality’s Bobby Krishna told Food Safety News. “Third party accreditation in the U.S. would mean third party certification in this part of the world.”
When Taylor spoke to the Global Food Safety Conference in London last month, he made it clear how concerned the American government is about imports. “Consider just a few numbers,” he said, “15 percent of the entire U.S. food supply is imported, including about 50 percent of our fresh fruits, 20 percent of vegetables, and 80 percent of our seafood.”
Dramatic increases in those numbers are the reason, Taylor said, that Congress passed the FSMA, which gives, for the first time, defined responsibility and accountability to importers for the safety of food brought into the U.S.
Taylor said “accredited third-party certification” would play a critical role in implementing the new law. Just how all this is going to happen remains to be seen.
One place to look for clues is that 2009 paper on “Voluntary Third-Party Certification Programs for Foods and Feeds.” “FDA will consider the 2009 guidance, among other things, as it develops the process, ” says agency spokesman Sebastian Cianci.
The “2009 guidance” sums up what came of a 2007 Interagency Working Group on Import Safety. It envisioned FDA recognizing a “certification body” that in turn would be responsible for accrediting its auditors.
Qualifications and training requirements were also spelled out. It said FDA would require a bachelor’s degree or higher from an accredited college or university with at least 30 semester hours of study in biological and other sciences. There was also an alternative for 30 hours of statistics and computing.
It also wants field training.
There are plenty of areas that have sparked controversy. The Third Party Auditing industry has been working behind the scenes on FSMA requirements ever since it first went before Congress.
FDA has long wanted accredited third party auditors to immediately notify the agency if a situation posing an immediate threat to public health is found. The industry is concerned about “due process.”
One veteran third party auditor said that system “might also put undue stress on the audit process and make the audit results more biased in the long run.” He said FDA should consider accrediting auditing firms with these qualifications at a minimum:
— Have qualified personnel, management and field; such qualifications are currently not uniformly specified.
— Provide open communications with consumers, buyers, and governments of exporting and importing nations.
— Hold international ISO accreditation, and be independently audited against the ISO standard.
— Be carefully monitored for performance standards, which need to be set, with other criteria.