- Compliance dates for the Food Safety and Modernization Act (FSMA) vary by the size of the company, but the largest food and beverage companies are facing just over a month until their Sept. 16 deadline.
- Many, if not most, of the larger food and beverage facilities have already been making the necessary changes and are "definitely getting there," Donna Garren, regulatory affairs and technical specialist at the American Frozen Food Institute, told Food Safety News. She said companies are "really committed" to the effort, but admits that others may need more information to meet the upcoming deadline.
- While the first compliance date is in September, the FDA still needs to train inspectors for the estimated 97,600 domestic and 109,200 foreign facilities it oversees. Inspections may not begin until closer to January, said Jim Gorny, vice president of food safety and technology for the Produce Marketing Association, during a recent presentation at the Center for Produce Safety’s annual research symposium.
The question on many manufacturers' minds — as surveys show a notable portion of food and beverage professionals are still unsure of their facilities' compliance with the new law — is what happens if a facility doesn't meet the FSMA deadline. Gorny said in his presentation that FDA inspectors will likely start visiting facilities without notice.
The FDA could issue a warning letter of violations with a list of required changes that the company needs to make, after which the agency will reinspect. The FDA can also ask the facility to recall products voluntarily; mandate recalls; withdraw a facility's registration; or seek a permanent injunction in court, Gorny said.
Ultimately, the FDA and manufacturers want FSMA preparation to reduce instances of foodborne illness. However, if enough companies are not in compliance with the regulations, it could cause a spike in recalls next year. While the increase in recalls might not indicate that the food supply is any less safe than it was before, the high financial and reputation costs could be enough to encourage the remaining manufacturers to comply.
FSMA requires registered food facilities that manufacture, process, pack or hold food to develop and maintain a food safety plan; perform a risk analysis for potential food safety hazards within their operations; and put in place preventive controls that reduce or eliminate the risk of those hazards. Facilities need extensive documentation to verify these assessments and the efficacy of their preventive controls, and must re-analyze their food safety plans at least once every three years.