On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule under the Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls requirements mandated by FSMA. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those with fewer than 500 such employees.

The compliance dates for the Preventive Controls (PC) and Current Good Manufacturing Practice (CGMP) requirements are staggered for animal food companies. FDA believed a year to solely focus on CGMPs would provide a helpful foundation prior to implementing preventive controls. Large and small facilities previously had to meet the CGMP requirements by September 2016 and September 2017, respectively. Also on September 17, 2018, facilities that are very small animal food businesses will be required to comply with the CGMPs. Very small businesses are those averaging less than $2.5 million per year in sales plus the market value of animal food they make or hold. These facilities are exempt from the full preventive controls requirements, but they have an additional year to meet the requirements applicable to qualified facilities.

FDA also published a conversation with consumer safety officer Jenny Murphy from FDA’s Center for Veterinary Medicine. In the conversation, Ms. Murphy explains what animal food producers can anticipate in this phase of implementation of the rule. 2018 will be the first year in which all three business sizes (large, small, and very small) have reached at least one of their compliance dates. 2018 will also be the first year in which FDA will begin routine regulatory inspections to ensure compliance with the preventive controls requirements. Additionally, Ms. Murphy discusses the available resources to assist industry with implementing the regulations, as well as how the final rule applies to producers of human food who supply by-products for use as animal food. Lastly, Ms. Murphy emphasized that FDA is currently focused on educating food producers to ensure the proper development, implementation, and fine tuning of their preventive controls and current good manufacturing practice requirements.