Regulatory Round-Up: Third-Party Audits, GFSI and FSMA – FDA Seeks Strategic Partnerships for Imported FoodsPatrick Kennedy /
Questions about the role of industry standards for complying with the Food Safety Modernization Act (FSMA) have existed since the law was enacted more than six years ago. Due to the upcoming requirements for foreign supplier verification, industry stakeholders are urging the FDA to extend the compliance date, and to clarify the role of private entities for supporting compliance with the new FSMA requirements for imported food.
The role of strategic partnerships for improving the safety of imported food was the focus of a two-day FDA public hearing held last week (February 14-15, 2017). The hearing followed public meetings held last year on imported food safety, which raised questions about the role of private certification schemes and third-party audits for supporting compliance with FSMA by foreign suppliers.
In contrast to previous FDA meetings, this month’s hearing on food imports revealed the agency has a greater interest in working with private entities such as third party auditors and the Global Food Safety Initiative (GFSI). The agency is now requesting public input on how private entities can align with and support the implementation of FSMA requirements for imports.
The key topics addressed during the hearing included the development of strategic food safety partnerships, the use of private standards in risk-based decision-making, the recognition of commodity-specific export programs, and the ongoing systems recognition program for regulatory equivalency between countries.
Imported food has steadily increased as a common vehicle of foodborne illness outbreaks in the United States. Last week, the Centers for Disease Control and Prevention (CDC) published a report of foodborne illness data from 1996 to 2014 that revealed imported food was implicated in 195 outbreaks, and the average annual total of outbreaks traced to imported food increased from 3 (1996-2000) to 18 (2009-2014). Currently, the FDA inspects about 2 percent of all imported food shipments, but products may be detained if they appear to violate FDA food safety laws and regulations. The majority of the outbreaks named in the CDC report were attributed to fresh produce imported from Mexico, Chile and Costa Rica.
The safety of imported fresh produce was highlighted during last week’s public hearing. It is estimated that 50 percent of fresh fruits and 20 percent of fresh vegetables consumed in the U.S. are imported. To improve the safety of fresh produce, the agency is currently evaluating USDA’s GAP program to determine if these standards align with FSMA requirements.
Audits and GFSI
During the hearing, the potential role of third-party audits was discussed in relation to the accredited third party program, produce safety, and supplier verification activities in FSVP and preventive controls.
Julie Moss of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) indicated the agency was “in dialogue with GFSI” to “determine if audits and certain schemes can serve as a verification activity” under the Foreign Supplier Verification Program (FSVP) for produce. Going forward, Moss suggested the next step would be to “understand the auditor competency requirements and the oversight of the program” for alignment with the FSMA requirements for supplier verification.
The role of audits for foreign supplier verification provoked several questions from industry participants. For example, will the FDA use information from third parties to support risk-based decisions? The FDA suggested it would explore ways to build on private audit activities. In the case of imported produce, the agency confirmed it plans to work with industry and “private partners to strengthen the rigor and reliability of private audits.”
Equivalent Food Safety Systems
Systems recognition, regarding the equivalency of comparable food safety systems to the U.S. system, was another subject discussed during the meeting. The food safety systems of Canada and New Zealand are now recognized as equivalent to the U.S., but the FDA’s evaluation of the European Commission and Australia is ongoing. Food shipments from countries with equivalent food safety systems are largely exempt from FSVP requirements.
Deadlines are fast approaching for the FSMA requirements for supplier verification under the Preventive Controls for Human Food (PCHF) rule (March 2017), and the Foreign Supplier Verification Program (FSVP) (May 2017).
During the meeting, several participants inquired about the status of the FDA guidance to support industry compliance with the foreign supplier verification requirements. The FDA representatives suggested the current administration’s opposition to issuing new federal regulations could be an impediment to future FSMA regulations, but the guidance will be forthcoming.
Several food industry groups have expressed concerns about uncertainties related to the upcoming foreign supplier requirements. On February 13, the leading food industry groups submitted a petition urging the FDA to postpone the compliance deadline for the FSVP requirements by one year to May 2018.
Looking to learn more about Foreign Supplier Verification Programs under FSMA regulations? Attend our upcoming short course, “How To Build and Implement an Effective Foreign Supplier Verification Program.”
Mérieux NutriSciences consultants can support the development and enhancement of food safety programs for facilities in preparation for certification against one of the GFSI benchmarked schemes, including Safe Quality Food (SQF), BRC (British Retail Consortium) and FSSC (Food Safety System Certification) 22000.
Mérieux NutriSciences Certification, LLC is an independent subsidiary of Mérieux NutriSciences established to provide clients with certification to many internationally recognized schemes, including GFSI endorsed schemes.
Meet the Author
Information Services Manager, Mérieux NutriSciences
Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.