On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (the “Final Rule”), 80 Fed. Reg. 56170 (Sept. 17, 2015). Additional information on the FSMA and the Final Rule can be found on FDA’s website at FDA Food Safety Modernization Act (FSMA).
A brief overview follows, but for a more thorough and comprehensive report, this memorandum summarizes the major components of the Final Rule with a particular focus on the new provisions that were not included in the Proposed Rule or Supplemental Proposed Rule.
The Final Rule is a culmination of multiple years of rulemaking. Section 103 of FSMA added a new section 418 to the Federal Food, Drugs, and Cosmetics Act (FD&C Act) that required FDA to promulgate regulations that require registered food facilities to establish and implement a food safety system that includes hazard analysis and risk-based preventive controls. Many of the provisions in the Final Rule were initially introduced in prior FDA proposals. After significant input from industry stakeholders, FDA has incorporated many of these suggestions into the Final Rule.
The major provisions of the Final Rule include:
- Current Good Manufacturing Practices (CGMPs) – Under Subpart B of the Final Rule, registered animal food facilities will need to comply with CGMPs that address food safety concerns associated with the manufacturing, processing, packing, and holding of food for animals.
- Hazard Analysis and Risk-Based Preventive Controls – Under Subpart C of the Final Rule, certain domestic and foreign animal food facilities will need to establish and implement hazard analysis and risk-based preventive controls for animal food. Registered facilities subject to Subpart C must maintain a written food safety plan, perform a hazard analysis, and institute preventive controls to mitigate the identified hazards. Additionally, registered animal food facilities will be required to monitor their preventive controls, conduct verification activities to ensure the preventive controls are effective, take appropriate corrective actions, and maintain records documenting these actions.
- Supply-Chain Controls – Under Subpart E of the Final Rule, animal food manufacturing/processing facilities will be required to have a risk-based supply chain program for those raw materials and other ingredients for which the facility has identified a hazard requiring a supply-chain-applied control. If the animal food facility controls the hazard using preventive controls, or follows specific requirements when they rely on a customer to control the identified hazards, they do not need to have a supply-chain program for that hazard.
Animal food facilities will be responsible for ensuring that raw materials and other ingredients that are controlled by a supply-chain program are received only from approved suppliers.
Preventive controls will not be required at facilities when an identified hazard is controlled elsewhere in the distribution chain (e.g., a customer or other processor). The facility will have to disclose that the food is “not processed to control (identified hazard)” and will also have to obtain a written assurance from their customer in regards to actions that the customer agrees to take.
- Vertically-Integrated Farming Operations – Feed mills associated with fully vertically-integrated farming operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) are considered “farms” and are not subject to the CGMPs or preventive controls. This is the case even in instances where the feed mill is not located on the same property as the animals.
However, in the instance where a feel mill is owned by an entity that contracts out the task of raising the entity’s livestock or poultry, the feed mill is not considered to be part of a “farm.” FDA reasons that these feed mills cannot be considered part of a farm because they manufacture feed for animals that are not managed by the feed mill’s owner. As such, feed mills that serve contract livestock and poultry farmers are subject to the Final Rule’s CGMP and preventive controls requirements.
Fearing that the farm exemption leaves significant gaps in the protection of human and animal health, FDA has indicated that the agency will propose a subsequent rulemaking that would apply CGMP and preventive control requirements to some feed mills that service fully vertically-integrated farming operations.
- Staggered Compliance Timelines – The deadlines for compliance with the CGMPs and preventive controls will be staggered. Furthermore, “small” and “very small” businesses will have additional time to comply with the provisions of the Final Rule. Section VII discusses the compliance timelines in further detail.