The FDA has issued two important final rules that will implement requirements of the Food Safety and Modernization Act (FSMA):

• Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food

• Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Animal Food

Both rules will require manufacturers and other elements of the food chain to evaluate, implement, and document the effectiveness of science-based preventive food safety programs.

Under the CGMP/hazard analysis human food final rule, significant changes or elaborations upon earlier proposals, in addition to new requirements, include the following:

1. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls, as well as monitoring, corrective actions and corrections, and verification (e.g., product testing and environmental monitoring, via oversight and management of preventive controls).

2. The definition of “farm” is clarified to cover two types of farm operations—primary production farms and secondary activities farms—where operations defined as “farms” are not subject to the preventive controls rule.

3. Establishment of a supply-chain program mandating different requirements and implementation dates for manufacturing/processing facilities, covered food facilities, and other entities within the supply chain.

4. Updated CGMP requirements for management and employee training and education.

5. Establishment of compliance dates for small businesses, very small businesses, businesses subject to the Pasteurized Milk Ordinance, and other businesses.

Under the CGMP/hazard analysis animal food final rule, significant changes from proposals include the following:

1. Establishment of CGMPs for the animal food industry and establishment of standards for producing safe animal food, including distinguishing between holding and processing of by-products and the requirements for each.

2. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls, as well as monitoring, corrective actions and corrections, recall plans, and verification (e.g., product testing and environmental monitoring, via oversight and management of preventive controls).

3. Establishment of a supply-chain program mandating different requirements and implementation dates for manufacturing/processing facilities, animal food facilities, and other entities within the supply chain.

4. Feed mills associated with fully vertically integrated farming operations (i.e., farms where the feed mill, animals, land, and establishments are all owned by the same entity) are not covered by the rule.

5. Establishment of compliance dates for small businesses, very small businesses, and other businesses.