The animal food industry experienced a sudden increase in the regulatory obligations in recent years. Through the Food Safety Modernization Act (FSMA) and its implemented regulations, food facilities must now operate under legally established current Good Manufacturing Practices (cGMPs) and risk-based preventive controls for food safety hazards.
Regulatory Framework: Before and After the new rule
Under the previous regulatory environment, the law mandated that animal food must be safe and that it could not be “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”[1] Except for medicated feeds, FDA had not established legally mandated practices for the manufacturing and storing animal foods – unlike human foods. In this legal vacuum, Association of American Feed Control Officials (AAFCO) established a model code for Good Manufacturing Practices.
Furthermore, FDA placed inspecting animal food facilities on a low priority. Notably FDA’s inspection manual provides little guidance on how to inspect such facilities, and a review of FDA’s inspection database indicates that FDA performed few inspections. Instead, FDA traditionally cooperated with states’ agricultural officials to oversee the animal food facilities’ manufacturing practices.
Current Good Manufacturing Practices
Current Good Manufacturing Practices (cGMPs) provides minimum standards that a facility must comply with for establish sanitary conditions. The regulations have standards for the (1) physical components of the facility (for example appropriate maintenance of grounds, utensils and equipment, plant design, functioning plumbing system) and the (2) operations of the facility. These regulations are similar to those that FDA established for human food.
System to Prevent Food Safety Hazards (Hazard Analysis and Preventive Controls).
Additionally, FDA requires a facility to conduct an analysis to identify the known or reasonably foreseeable hazards for each type of animal food. For those hazards, the facility must design appropriate controls to significantly minimize or prevent the hazards, and monitor the controls to manage the implementation. This process then manifests itself into the facility’s food safety plan. For those familiar with the Hazard Analysis Critical Control Point (HACCP) regime, the new requirement will feel familiar. Also this rule mirrors the same rule for human food.
FDA created tiered compliance date for both the cGMP and Preventive Control regulation. For the cGMP regulation, the earliest compliance date was September 16, 2016, and there are several more dates based upon the facility’s size. For the Preventive Control regulation, the earliest compliance date is September 18, 2017.
Foreign Supplier Verification Program
Importers will need to be ready for the Foreign Supplier Verification Program (FSVP), another outcome of FSMA that impacts the animal food industry. The FSVP rule, designed to ensure the safety and compliance of imported food from foreign suppliers, requires non-exempt importers to establish written procedures for evaluating the hazards and risks associated with each foreign supplier and imported food. Importers will have to identify all potential hazards related to each of their food products, including harmful bacteria, illegal pesticide residues, harmful chemicals, radioactive particles, unapproved additives, and glass or metal, and then evaluate the risks presented.
Business Impact to Industry
The new legal requirements are restructuring how FDA and the industry interact with each other. There will a transition period and it remains unclear how FDA will allocate its limited resources to inspect facilities for compliance with these requirements. However, it is essential for a facility to recognize that the legal obligations have changed and to revise its practices accordingly.
For more information regarding FSMA please watch our video: Overview of FSMA (FDA’s Food Safety Modernization Act)
The teams at FDAImports.com and Benjamin L. England & Associates stand ready to assist industry with FSVP hazard analyses and risk evaluations, cGMP reviews, Preventive Control assessments, FDA registration, USDA permits, and AAFCO requirements. Our attorneys and former FDA-officials help companies comply with agency regulations and successfully get their products to the US market. Contact us today.
[1] Food, Drug, and Cosmetic Act, Section 402(a)(4).
