FDA Sheds Light on FSMA’s Preventive Controls

admin-qsi / June 16, 2017

The agency gives industry some insight on what to expect with the first FSMA compliance date. September 19, 2016, marked the first major FDA Food Safety Modernization Act (FSMA) compliance date. Larger companies must meet certain requirements of the Preventive Controls for Human Food final rule related to current good manufacturing practice requirements. In anticipation of the questions surrounding these requirements, FDA released a Q&A with Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of the agency’s Food and Feed Program in the Office of Regulatory Affairs. What happens next in terms of FDA enforcement of these new standards? The primary focus continues to be on education, training, and technical assistance to help companies comply with the new requirements. A top priority is providing the framework for industry’s implementation of preventive controls and CGMP requirements. The first year of compliance will affect larger businesses (500 or more employees). The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply. Does the focus on education mean that companies won’t really be held to these standards yet? No. FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. Our primary goal is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that will minimize the risk of serious illness or death. What is the best thing covered food facilities can be doing now? The best thing people in the food industry can do is take 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. In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company demonstrates that it is meeting the legal standard. 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 can take its place. If there is a problem, state or federal investigators ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees? Where can companies go wrong? 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 FDA 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 everyone in the production chain understands what is expected and has the training and education they need to get the job done. What is the ultimate goal? 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 CGMPs, 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. Article Excerpt from Food Safety Tech

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