The first major compliance dates for the preventive controls rules for human and animal food under the Food Safety Modernization Act occurred on September 19, 2016. 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, addressed questions that have been raised about what the next few months will bring in a special FDA announcement this week.
Givens says FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements. A top priority for FDA is providing the framework for industry's implementation of preventive controls and CGMP requirements. The agency recently issued draft guidance documents that provide more detail on how to comply with the new standards. But there are about two dozen more on the horizon over the next few years.
This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program, and aspects of the CGMP and preventive controls rules are similar to HACCP. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)
FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. The agency urges industry to keep in mind that its 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 and a culture of compliance with procedures, processes and practices that will minimize the risk of serious illness or death.
