The U.S. Food and Drug administration (FDA) submitted the final rules on preventive controls for human and animal food to the Federal Register on Monday for publication and incorporation into the Food Safety Modernization Act (FSMA).
Preventive controls are one of the five major elements of FSMA and are a legislative mandate to require overarching, prevention-based controls across the human and animal food supply. The controls for animal food will call for current good manufacturing practice regulations for human food to be made more applicable to animal food production and will likely contain a regulatory framework for hazard analysis control and feed mills associated with farms.
Compliance dates will be staggered according to the size of food production facilities. Small businesses, those with less than 500 employees and not qualified for an exemption, will have two years after publication of the final rule to comply. Very small businesses having less than $2.5 million in total annual sales of animal food, adjusted for inflation, will have three years to comply. Very small facilities will still be considered “qualified facilities,” and will be subject to modified requirements for preventive controls. All other businesses that are not small/very small and do not qualify for exemption will have to be compliant one year after the final rule is published.
All food-production facilities are required to have written preventive control plans which include the following:
1. Evaluation of hazards that could affect food safety;
2. Specification of what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards;
3. Specification of how the facility will monitor these controls to ensure they are working;
4. Maintenance of routine records of the monitoring; and
5. Specification of what actions the facility will take to correct problems that arise.
A link to the proposed preventive control rule for food for animals may be found here. NCC’s comments on the proposed rule may be found here.
