Public-Private Sector Working in Harmony

“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.