With the passage of the Food Safety Modernization Act (FSMA) in 2011, the food industry overseen by FDA experienced the most extensive regulatory overhaul in the last 70 years. In the years since, auditing, which is used to both evaluate whether a food safety system is appropriate and effective, and to verify whether it is in compliance with certain industry or government standards, is also in a whirlwind of transition.
For instance, in 2010, the year before FSMA was signed into law, a cut green bean processor in the U.S. would have undergone regulatory inspections as well as several customer audits, either via first-party audits performed by the customer’s staff or third-party audits conducted by an outside company. As a condition of supplying a major retailer such as Walmart, the processor would also have been required to participate in a third-party audit for one of the Global Food Safety Initiative (GFSI) certifications, which is a food safety auditing platform that established a standardized level of global food safety requirements almost two decades ago.
However, in 2019 under new FSMA regulations, the farm supplying green beans to that processor is now also experiencing its first round of regulatory inspections on the federal level. What’s more, certain segments of its supply chain that were somewhat overlooked in the past (e.g., harvesters, packing facilities, etc.) are now also subject to regulatory inspections and may opt to seek out third-party auditing to confirm that their food safety management systems address all FSMA requirements.
In the current food safety auditing climate, that means that more than half of U.S. food facilities have five or fewer audits a year while a third have anywhere from six to 20 audits annually, according to a spring 2019 poll of U.S. food businesses by Lloyd’s Register.
“It remains to be seen if the volume of customer audits and request or requirements for GFSI third-party audits will decrease as FSMA implementation and regulatory inspections ramp up over in the coming years,” says Willette Crawford, principal, Food Safety and Regulatory Compliance at Katalyst Consulting. Yet regardless of what’s coming in the future, the food safety auditing industry is currently straddling two approaches as it attempts to efficiently integrate FSMA requirements into existing food safety management systems.
Prior to FSMA, although FDA required Hazard Analysis and Critical Control Points (HACCP) for seafood and juices, it was not required for the bulk of FDA-regulated products. In fact, the Federal Food, Drug, and Cosmetic Act of 1938 was the last major federal legislation passed to improve food safety for FDA-regulated facilities in the U.S.
To fill this gap in regulation and streamline auditing, a group of major retailers came together in 2005 to create GFSI, an auditing platform that made HACCP a fundamental food safety requirement for a scheme to be recognized by GFSI, setting the baseline above FDA’s regulatory requirements at that time. Individual GFSI schemes include FSSC 2200, SQF, and BRC, all of which have been widely used by industry and executed by third-party auditors internationally for the last 15 years.
A series of high-profile and deadly foodborne illness outbreaks, many tied to imported foods, prompted Congressional action. Signed into law in 2011, FSMA directed FDA to develop U.S. food safety regulations focused on prevention across the entire supply chain. Under one of FSMA’s seven rules, the Preventive Controls Rule for Human Food, FDA’s regulations now require that domestic food facilities and those importing to the U.S. develop, document, implement, validate, and keep records of a food safety plan. This food safety plan must identify food safety hazards and adulteration risks associated with the specific foods and processes involved, assess the level of risk involved, and implement controls to minimize those risks. The plan must verify that the controls used are effective, and define the corrective actions necessary to address deviations from applied controls. FSMA includes a similar rule for animal foods, and a Produce Safety Rule that addresses farm food safety.