Jay Sjerven

The first major compliance date for preventive rules for human and animal food under the F.D.A. Food Safety Modernization Act (FSMA) was Sept. 19. As of that date, larger businesses must comply with new standards; principally, manufacturers must meet preventive control and Current Good Manufacturing Practice (C.G.M.P.) requirements, and animal food companies must meet their specified C.G.M.P.s. The Food and Drug Administration in recent days issued the first draft guidance documents providing details on how food companies may comply with the new standards, and agency officials advised the food industry on what to expect in the next few months under FSMA.

“We know this is new territory for food companies,” said Joann Givens, co-chair of the FSMA Operations Steering Committee and director of the F.D.A.’s Food and Feed Program in the Office of Regulatory Affairs. “It’s new territory for us, too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the F.D.A.’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.”

Ms. Givens said a top priority for the F.D.A. is providing the framework for industry’s implementation of preventive controls and C.G.M.P. requirements. As part of that effort, the F.D.A. on Aug. 23 issued the first five chapters in what will be a 14-chapter draft guidance for industry on Hazard Analysis and Risk-Based Controls for Human Food. The five published chapters are as follows: The Food Safety Plan; Conducting a Hazard Analysis; Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food; Preventive Controls; and Application of Preventive Controls and Preventive Control Management Components.

Additional chapters will follow soon. Ms. Givens said even more guidance documents were to come during the next few years.

Many large businesses already have a HACCP (Hazard Analysis and Critical Control Points) program, and “we don’t expect them to need to make many changes to come into compliance,” Ms. Givens said.

Addressing the question whether the F.D.A.’s focus on education meant companies won’t be held to the standards yet, Ms. Givens said, “No. The F.D.A.’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 or death.”

Ms. Givens advised, “The best thing that people in the food industry can do is take the measures required by the new rules — not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.”

Ms. Givens said facilities should set up a thorough system for documenting what they do.

“The better the records, the more a company can demonstrate that it is meeting the legal standard,” she said. Also, facilities should put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another may take its place.

“If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?” Ms. Givens advised. “A company’s approach should not be: ‘The government was here and did our inspection. We’re safe for X amount of time.’ Rather, we want facilities to be confident that if F.D.A. or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements. And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.”

Ms. Givens emphasized, “The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law. The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with C.G.M.P.s, will help protect consumers into the future. We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.”