This is Part 2 of this article on FSMA guidance. If you missed Part 1, be sure to read it here.
“In reality, FSVP applies to the US-based owner of the imported products,” said Jeff Wilson, Vice President, Food Safety Services, Europe, Asia and Africa. “The rule entails a fundamental shift in the oversight of imported foods from a system that relies on the examination of imported foods at the port-of-entry and reaction to market failures, to one where importers and their foreign suppliers are responsible for preventing food safety failures.”
All importers of food for human and animals, unless exempt or subject to modified requirements, will be required to develop, maintain, and follow a standard risk-based FSVP to ensure the food they import is produced in a way that provides the same level of public health protection as the preventive controls or produce regulations. The plan should also ensure that the supplier’s food is not adulterated or mislabeled by respect to allergens. AIB’s FSPCA Preventive Controls for Human Food course, staffed with certified lead instructors, are already scheduled monthly, and public FSVP courses are in the works later in 2017.
With compliance now effective, FSMA’s Sanitary Transportation rule also establishes food safety requirements for transportation carriers for the first time in FDA oversight history.
“This new rule fills a gap in the food safety supply chain,” Lopez said. “Truck drivers will now need food safety training related to refrigeration, temperature monitoring, product handling, and other sanitary transport practices.”
One complexity related to this rule is that the shipper designs the transport specifications, so carriers will need to know the transport specifications for every single shipper to whom they provide service.
In April 2017, AIB introduced their Consolidated Standards for Inspection of Bulk Sanitary Transport, and a related GMP Inspection for bulk sanitary transportation.
“The inspection addresses FSMA’s regulatory requirements and enables clients to identify and correct gaps,” said Anthony Raschke, Director, Food Safety Services Innovation. “Although the rule covers all carriers, the biggest industry need we’ve discovered is with wash bays assigned to bulk transports.” Although the inspection is based on FSMA’s Sanitary Transportation rule, it encompasses best practices in bulk transport and is therefore applicable globally.
As the industry braces for major changes in the way the FDA conducts facility inspections due to the changing requirements, AIB has identified a critical need for mock investigations.
“Our clients report that the FDA inspectors are taking a deeper look at their sanitation programs, conducting more employee interviews, and are looking more closely at training records,” Lopez said. “One particular client experienced a team of FDA inspectors that arrived at night to observe the sanitation operations and stayed for multiple days to complete the inspection.”
To ensure clients are ready, AIB launched the FDA Preparedness Inspection in October 2016. The inspection is a simulation that tests a facility’s response to FSMA-type inspections.
“The experience gives companies a better understanding of what FDA investigators are looking for and also pinpoints troublesome areas that might jeopardize compliance and tests employee interaction with investigators,” Burgess said. “It’s become a popular add-on to our GMP inspection.”
To further challenge whether a facility is food safety ready, some of AIB’s largest clients have also moved to unannounced inspections. These 24/7 audit-ready operations are tasked with cultivating a food safety culture that truly understands the importance of following prerequisite programs, Lopez said.
“AIB always has its ear to the ground to make sure that that the service we offer is in lock step with the latest regulations and food safety practices,” Lopez said. “We will continue to refine our offerings to help food plants minimize their risk of food safety contamination and exceed customer expectations for wholesome and safe products.”