We are approximately nine months into FDA’s animal feed and pet food facility inspections for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (PC) rule. With PC inspections starting for small businesses this Fall, there are a few lessons we have learned from the inspections that have occurred to date.
As a reminder, FSMA and the PC rule requires many animal food facilities to establish a food safety plan identifying and evaluating known or reasonably foreseeable hazards and implementing measures that significantly minimize or prevent such hazards. The PC rule also includes current good manufacturing practice requirements (CGMP) for these facilities, which are covered under a separate inspectional program.
According to data shared at a recent conference, FDA has conducted approximately 400 CGMP inspections and about 20 PC inspections. Approximately 6% of the CGMP inspections resulted in the issuance of a Form FDA 483, “Inspectional Observations.” As a result of the findings from those inspections, FDA has noted that animal feed facilities need to better focus on pest management and housekeeping, as the most commonly cited observations by FDA investigators related to facility and pest management. However, FDA has only issued one Warning Letter for deviations from the animal feed CGMP requirements.
Based on these inspections, we believe the following tips can help animal feed and pet food companies unfamiliar with the FDA inspection process:
- Expect a team of FDA and/or state officials to conduct the inspection;
- Be prepared for the inspection to branch out into other regulatory topics, including the BSE/ruminant feed and the veterinary feed directive requirements, if applicable to your facility;
- For facilities relying on a prerequisite program, in addition to a food safety plan, FDA will expect facility operators and personnel to be familiar with the contents of those prerequisite programs and implement them as written; and,
- Ensure that hazards identified in your hazard analysis are addressed by an appropriate preventive control and those preventive controls are properly implemented.
Compliance Policy Guides
FDA has withdrawn three compliance policy guides (CPGs) related to animal-derived ingredients, including byproducts or co-products, used in animal and pet feed:
- CPG Sec. 675.400 – Rendered Animal Feed Ingredients,
- CPG Sec. 690.300 – Canned Pet Food, and
- CPG Sec. 690.500 – Uncooked Meat for Animal Food.
These CGPs, which were issued several decades ago, were withdrawn following adoption of the animal food PC regulations. FDA stated that the CPGs were unnecessary because these hazards are more appropriately addressed in a facility’s food safety plan. This action by FDA should serve as a reminder to the industry that FDA expects animal feed and pet food producers to address hazards presented by the use of rendered ingredients from dead or downer animals.
What does this mean for you?
In light of these CPG withdrawals, animal feed and pet food companies should ensure their prerequisite programs and food safety plans appropriately identify and address all hazards at a facility and those introduced by ingredients. FDA has been actively inspecting large animal feed and pet food facilities for compliance with the CGMPs and PC requirements. Small companies should be prepared for these inspections to expand to their facilities this Fall.
Husch Blackwell has experience working with companies in complying with FDA regulations, including regulations governing the production of animal and pet food, and has members with the required scientific and technical backgrounds to assist companies with compliance. Contact Seth Mailhot, Mike Annis, Emily Lyons, or your Husch Blackwell attorney.