As the global food chain becomes more intertwined and as pressures to enhance food safety grow, government regulators in such diverse countries as the U.S., China, Canada, and Mexico are seeking to strengthen and streamline their inspection activities by leveraging private-sector audit and certification activities.
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The presumption is that private certification schemes, such as those recognized by the Global Food Safety Initiative (GFSI) or developed by the International Standards Organization (ISO) can help food facilities meet or exceed national food safety laws. Thus, food companies that have been audited and certified by organizations such as the SQF Institute, BRC Global Standards, or FSSC 22000 are highly likely to be in compliance with government food safety requirements. This would allow regulators to focus their limited inspection resources on unaudited companies, considered more likely to have food safety problems than audited and certified firms.
Canada is in the process of implementing a new certification policy that would tailor inspection and oversight activities to private audits. “Where companies are certified to be in good standing to a scheme that we’ve assessed, we will give them credit,” said Mark Burgham, senior director for program policy integration at the Canadian Food Inspection Agency (CFIA).
The audit credit would be entered into an algorithm that CFIA created, which also includes the firm’s compliance history, its inherent product and process safety risks, international intelligence, and other factors. Outputs from the algorithm “will influence the level of inspection, the frequency of inspection, or how we target specific direction to our inspectors,” Burgham told a GFSI-convened briefing in Washington, D.C. in November 2016.
In a pilot project, GFSI benchmarked schemes “met or exceeded” Canadian food safety standards for preventive controls, Burgham said. While CFIA will neither endorse nor recognize any specific private certification scheme, “there is recognition of great things going in industry that we need to understand better and ensure that we leverage,” he added. “So we will be looking at matching the highest risks with how we respond to them.”
Convergence with FSMA
“If you have a GFSI-benchmarked certification, you are very close to being compliant with FSMA [Food Safety Modernization Act],” said Mike Robach, chairman of GFSI’s board of directors and vice president for corporate food safety and regulatory affairs at Cargill Inc. “That’s the way we’ve prepared for it both with Cargill in the U.S. and in our facilities outside of the U.S. that export to the U.S.,” he told conference attendees.
In July 2016, Robach and other GFSI officials met with Stephen Ostroff, MD, FDA deputy commissioner for foods and veterinary medicine, to discuss a pilot project that would compare GFSI’s benchmarking requirements against FSMA regulations. As part of this effort, GFSI commissioned The Acheson Group, founded by David Acheson, MD, former FDA associate commissioner for foods, to conduct a side-by-side comparison of FSMA’s final preventive controls rule with GFSI’s new Version 7, due to be issued in January 2017. GFSI had planned to discuss the results of that analysis with the FDA in early 2017, Robach said.
“We hope and believe that given the alignment between GFSI and FSMA that there is a role for GFSI to play in demonstrating compliance with the new law as one of several risk-based criteria in compliance, just as we’ve seen with Canada,” Karil L. Kochenderfer, GFSI’s North American representative, tells Food Quality & Safety magazine.
The preventive controls rule (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food ) requires U.S. and foreign firms that manufacture, process, pack, or hold human food to have written plans that identify hazards, specify steps to minimize or prevent those hazards, identify monitoring and recording procedures, and specify actions that will be taken to correct problems that arise. FDA has the authority to evaluate these plans and inspect facilities to ensure the plans are being followed.
“GFSI Version 7 meets or exceeds all of the requirements in the FSMA preventive controls rule,” Dr. Acheson said. “GFSI sets you on an extremely good trajectory to be ready [for an inspection], and puts you in a very good place as to FSMA compliance,” he told the conference.
In some cases, GFSI Version 7 contains requirements that are not reflected in FSMA, such as for food safety management, responsibility, and resource management. Other GFSI elements, such as for traceability and food defense, are included in other FSMA rules. Dr. Acheson compared several GFSI schemes, including SQF, BRC, and FSSC, with FSMA. “All match up well and are essentially either comparable or exceeding FSMA,” he said.
For example, in a 2013 analysis, FSSC 22000 “often exceeds FDA requirements, either by being clearer about the specific expectations or by applying the requirements more broadly within a facility,” Dr. Acheson said. “A facility that has FSSC 22000 certification is in an excellent place with regard to compliance with PC rules as currently written.”
FSMA, like the Safe Food for Canadians Act, includes provisions that allow regulators to take into account private certification when evaluating compliance with the law. For example, FSMA’s preventive controls rule states that companies certified by GFSI or a similar system do not need to duplicate their existing records when certification requirements “mirror” FSMA’s. Similarly, facilities can use GFSI-compliant food safety plans when such plans meet the requirements of the rule.
“We expect that many existing plans will need only minor supplementation to fully comply with these requirements,” the preventive controls rule states. “Relying on existing records, with supplementation as necessary to demonstrate compliance with the requirements of the human preventive controls rule, is acceptable.” Nevertheless, FDA also makes clear that GFSI certification does not automatically guarantee compliance with the law.
“We have no plans to endorse certification under GFSI (or any other standard setting organization) as satisfying the requirements for validation,” the preventive controls rule states. “However, to the extent that scientific and technical information available from GFSI or another standard setting organization provides evidence that a control measure, combination of control measures, or the food safety plan as a whole is capable of effectively controlling the identified hazards, a facility may use such information to satisfy the validation requirements of the rule.”
As Dr. Acheson interprets this, “The FDA is saying that you can and should leverage all that you’ve done. If you are GFSI-certified you’ve done a lot of this; don’t do it all over again. Use it, leverage it to build your food safety plan. Rely on existing records and supplement them as necessary. Then be ready to show the FDA inspector your food safety program, when asked. You are going to heavily leverage your GFSI-certified programs in answer to that question,” he said.
Growing International Interest
Mexico and China appear to be following Canada’s lead, and officials from nearly two dozen other countries are at least exploring the possibility of incorporating private certification into their regulatory mechanisms. GFSI and Mexican officials are discussing a possible memorandum of understanding that would align GFSI certification with compliance to a new risk assessment and management norm proposed by Mexico’s National Service for Health, Food Safety and Agricultural Food Quality (SENASICA), GFSI officials tell Food Quality & Safety.
In November 2015, GFSI and China’s Certification and Accreditation Administration announced that Chinese Hazard Analysis and Critical Control Points were “technically equivalent” to the technical requirements of GFSI Version 6. Technical equivalence is a new category specifically for government-owned schemes, and is comparable to GFSI recognition for commercial schemes. “The Chinese government [is] the first government to approach GFSI and submit their national certification scheme to be assessed against the GFSI requirements,” GFSI announced at the time.
During last year’s Global Food Safety Conference (GFSC) in Berlin, Canada co-chaired a side meeting with representatives from 19 other nations to discuss the role of private certification in regulatory oversight. “We are going to continue this conversation and have another round of government-to-government meetings” during the February 2017 GFSC in Houston, Burgham said. Regulators in Canada and other countries have “a great opportunity to leverage the investments that private companies are making toward certification,” he added. “There are real opportunities for those parties to work together.”
Building Food Safety Capacity
As global markets expand, small food suppliers and processors in less developed countries will become more prominent. Helping them to become certified will help enhance the safety of the overall food chain. To advance this effort, GFSI and the United Nations Industrial Development Organization (UNIDO) agreed in June 2016 to develop a program to help small or less-developed food companies become certified, allowing them to potentially gain access to worldwide markets. The joint project is based on GFSI’s Global Markets Program, in which companies that lack or have underdeveloped food safety systems can gain market access through certification to one of the 10 GFSI-recognized schemes.
“This is not a small task. We want to enable the smaller or less developed companies and help them to build that food safety pathway within two years,” says Cindy Giang, senior director, global food safety and supply chain compliance for McDonald’s Corp. USA, and a GFSI board member. “We do not want to have any redundancy around food safety audits. We want to leverage resources, so once audited, once certified, then they are recognized by everyone. That’s our goal.”
Pilot projects have been established in China, in Southeast Asia, and Africa. “The World Health Organization estimates that up to 600 million people fall ill every year after eating contaminated food,” comments Philippe Scholtès, managing director, Program Development and Technical Cooperation, at UNIDO. “Our collaboration with GFSI will further strengthen and promote multiple benefits of safe food for social inclusiveness, sustainability, and industrial development.”