International Supply Chain a Challenge to FSMA’s Effectiveness

Among the many regulations the agency has drafted to implement the law—but not yet released at presstime—are those to establish the foreign supplier verification program, accredited third-party certifications, and third-party certification of high-risk foods. “FSMA shifts the burden to importers,” Dr. Acheson said. “They have to take responsibility for monitoring their imports upstream under FSMA.”

It is widely expected that the FDA will recognize and adopt at least some ISO standards for inspection and accreditation purposes. But until the FDA’s regulations are released (they have been held up under review by the Office of Management and Budget since at least January), details remain unknown. However, the law explicitly requires the FDA to consider existing standards for guidance to avoid unnecessary duplication of efforts and costs.

“FDA will recognize accrediting bodies and set standards for accreditation of third-party certification bodies and auditors aimed at ensuring the rigor, objectivity, and, most importantly, the transparency of third-party audits,” said Michael R. Taylor, FDA deputy commissioner for foods. “Transparency means that the results of audits for certification will be available to FDA, which in turn means that we can both assess the rigor of private audits and rely on them,” Taylor told the Global Food Safety Conference in Orlando, Fla., in February.

GFSI and Audits

Dr. Acheson expects the foreign supplier verification program to focus mainly on high-risk foods and incorporate standards similar to GFSI’s. “To some extent, it will intersect with GFSI, but my guess is that it won’t be quite the same,” Dr. Acheson said. “It will probably go a little beyond GFSI. I’m also guessing that GFSI will adapt itself to whatever standard that FDA puts in place.” The FDA has refused to comment on any possible role that GFSI or other organizations might play in its standards setting.

Craig W. Henry, PhD, director of enterprise risk services-business risk at Deloitte & Touche LLP, predicted that accredited third-party certifications and audits will become even more complicated under FSMA, because the FDA’s criteria “could be in tandem or potentially in conflict with the third-party audits that are available and used commercially today around the world.”

“This is especially important for produce, where you don’t want a short shelf-life product sitting in port under test and hold,” Dr. Henry told Food Quality. “You’ll want to make sure that the FDA will recognize the food safety system that’s being used, and you want to make sure that product is in the green lane as soon as possible.”

Many large companies use GFSI as a baseline but also send their own auditors overseas to inspect facilities, especially when ingredients may be particularly vulnerable to problems and their brand reputations are at stake. “That’s very prevalent among large U.S. manufacturers,” Dr. Acheson explained. “In addition, the GFSI audit is only as good as the auditor. He or she may be having a bad day or, who knows, they may even have accepted a bribe.”

“Auditor competences are critical to the success of our mission,” acknowledged Yves Ray, GFSI chairman and general manager for corporate quality at Paris-based Danone. “Food safety hazards may be introduced at any point along the food chain. One weak link can result in unsafe food harmful to consumer health and very costly,” he told the annual Food Safety Summit in Washington, DC, in April.

Paperwork: A two-edged Sword

Many companies believe they create and maintain the proper records and have a good document control system in place to support their food safety programs. But these may not be enough. “These companies need to go back and really understand how their standard operating procedure is being implemented and consistently executed across all their facilities,” Dr. Henry said. “They need to understand that anything going back two years will be fair game.”