By Charles Breen, Independent Advisor for FSMA
Although six months have passed since the compliance date for large animal food facilities to meet Good Manufacturing Practices (GMPs) and Preventive Controls requirements, and for small animal food facilities with fewer than 500 full-time equivalent employees, to meet the GMPs, the pet food industry in particular continues to struggle with the FSMA Final Rule for Preventive Controls for Animal Foods. Despite FDA having indicated that the industry should expect greater inspection activity for GMP compliance after September 18, 2017, numerous recent recalls suggest an excess of complacency on the parts of some, and a challenge in understanding and meeting the requirements of others.
Recent popular trends for raw meat diets in pet food have led to a spike in the frequency of recalls for pathogen contamination. Contamination in pet food and animal food, much like human food, can cause ill effects and even death. In the case of pet food, cross-contamination also has the potential to cause harm to humans.
The final rule requires animal food facilities to have a written food safety plan, including GMPs, and controls in place for any hazards identified as part of a required hazard analysis. In addition, risk-based preventive controls must be in place for processes, as required, to reduce or eliminate the risk of additional contaminations. FDA’s staggered compliance dates are based on the size of a business, with the next compliance date for small businesses to meet preventive controls requirements in September 2018, at which time very small businesses will need to meet CGMPs. Large firms were expected to have preventive controls in place effective September 2017. However, FDA will not begin conducting routine inspections of preventive controls until the fall of 2018, allowing time to ensure companies understand and are able to meet those expectations. FDA also just released draft guidance to help firms determine whether they meet the definition of a small business, which of course directly impacts whether the company is exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Also, small businesses have later compliance dates for parts 117 and 507 than larger businesses.
What is the difference between GMPs and Preventive Controls? Jenny Murphy, a consumer safety officer with FDA’s Center for Veterinary Medicine says in a Q&A that GMPs are more basic, including items one would do in the normal course of business to establish a base to prevent contamination. Preventive controls focus prevention of harm by controlling risks to public health. “Once you have CGMPs in place,” she says, “you can see where you need extra layers of protection. Preventive controls require a food safety plan that includes an analysis of potential biological, chemical or physical hazards and the steps needed to reduce or minimize that risk.”
The written food safety plan is required to have a hazard analysis. Hazards identified as needing preventive controls, such as process controls, sanitation controls, and others, require firms to implement controls to ensure those hazards are reduced or eliminated in all foods the facility manufactures, processes, packs, or holds, and when applicable, supply-chain programs. A recall plan is also required. Preventive Control plans must be prepared by or the preparation overseen by a “preventive controls qualified individual” for animal food.
I’ll bring to your attention a recent webinar hosted by EAS independent consultant, Dr. Omar Oyarzabal, an expert of acidified foods, who recently hosted a webinar on FSMA impacts on Acidified Foods along with Priya Rantham, an FDA Consumer Safety Officer. The process controls of acidifying foods are complex. Dr. Oyarzabal does an excellent job of simplifying the understanding both in this free on-demand webinar and in a Q&A based on the webinar recently published in Food Safety Tech.
In addition, regarding sanitary controls, EAS Independent Consultant Dr. Kathy Glass and Senior Director for Food Consulting Services, Allen Sayler, answered many questions on contamination and control of Listeria monocytogenes. While this information was directed at RTE human foods, much of the information is also applicable to animal foods.
On the subject of EAS resources, you may also be interested in an EAS produced FSMA pocket guide, which contains the 21 CFR Part 117 regulation. This pocket guide is also available digitally as a free download from our website.
The FSMA Final Rule for Preventive Controls for Animal Foods is just one of FDA’s many efforts at requiring and enabling greater control and oversight of safety for all manufacturing, processing and holding facilities of human and animal foods and animal feed. Through a combination of GMPs, hazard analysis and risk-based preventive controls, we can expect greater food safety for all.
Please reach out to EAS if you have any questions on this or other FSMA rules. We offer comprehensive services in this area and would be glad to discuss your firm’s readiness and compliance with FSMA requirements.