FDA: Education is the key to getting on track with FSMA
Companies and FDA inspectors both still learning FSMA
While the compliance dates have already arrived and passed for the preventive controls rules for human and animal food for large food and beverage processors, FDA recently reminded small businesses and very small businesses that they must comply with the same rules by Sept. 18, 2017 and Sept. 17, 2018 respectively. Small businesses are defined as those with fewer than 500 employees, and very small businesses generally average less than $1 million per year in human food sales or $2.5 million per year in animal food sales. Very small businesses must maintain records supporting Qualified Facility status as of January 1, 2016.
In an FDA-conducted interview, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, responded to questions relating to what the immediate future holds for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with CGMP rules.
“For years, we’ve been talking about FSMA rulemakings and our implementation plans,” said Givens. “Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.”
With a focus on education, it might seem that FDA will be lenient with companies that aren’t yet up to snuff. Not true, according to Givens; processors will be held to the rules. “The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes and practices that we know will minimize the risk of serious illness and death.”
However, the learning experience is not always one sided—FDA inspectors are learning, too, said David Acheson in a recent “FSMA Fridays” webinar conducted by SafetyChain Software. Acheson is CEO of The Acheson Group (TAG) and formerly FDA associate commissioner for foods. One of TAG’s clients, which is well prepared for an FSMA inspection, had a knock on the door by an FDA inspector. When the processor asked if the inspector was ready to do an inspection, the answer given by the FDA inspector surprised the food company: “Oh, no. I’m not here to do that. I’ve just completed my PCQI [Preventive Controls Qualified Individual] training, and I’ve really come here to look at what you’ve done—to learn from you.” Acheson suggested that there will be many opportunities for FDA inspectors to learn from the private sector, but it also “raises a concern that the private sector will know a whole lot more about the details and rules than the inspectors.”
Acheson warned, however, that many FDA inspectors will obviously be very competent, and while education, training and technical assistance are very important and can give a processor a “nice, warm and fuzzy” feeling about the FDA, processors should not be lazy or complacent and not prepare—because FDA has the authority to close down facilities due to a lack of compliance or a food safety incident.
Meanwhile, the Food Safety Preventive Controls Alliance (FSPCA) reports good attendance at all courses given around the country, and according to Katherine Swanson, FSPCA project manager, curriculum development, the FSPCA Preventive Controls for Human Food course is the “standard curriculum recognized by FDA.” FSPCA trains lead instructors, who then train “qualified individuals” who can be a food processor employee or a consultant. Lead instructors have access to instructor notes, exercise guides and instructions, and simplified model foods for exercises consistent with regulatory requirements, as well as all FSPCA current resources and information. The 526-pp. “FSPCA Preventive Controls for Human Food Participant Manual (Ver. 1.2)” is now available for a free download from the FSPCA website. Successfully completing this course is one way to meet the requirements for a PCQI, who can perform or oversee the preparation of a processor’s food safety plan, validation of the preventive controls, records review and reanalysis of the food safety plan.
The FSPCA Preventive Controls for Human Food Course is offered in both a formal classroom setting and a self-guided online version that is coupled with a one-day, in-person session to develop skills for conducting a hazard analysis and developing a food safety plan. The training materials include the standard training manual, slides, explanation of key terms and concepts, an example model of a food safety plan, abbreviated models for class exercises and reference materials.