By: Susan Mayne, Ph.D., and Tracey Forfa, J.D.
When we were drafting and seeking public comment on the rules that will implement the FDA Food Safety Modernization Act (FSMA), we promised that we would do whatever we could to help the regulated industry understand and meet the new requirements.
We meant what we said about “educating before and while we regulate,” since these new standards will ultimately transform the nation’s food safety system.
This month, we have taken important steps in fulfilling that promise with the release of three draft guidances that when finalized will help domestic and foreign food facilities meet the requirements of the preventive controls rules that became final in September 2015.
Those rules require hazard prevention practices in human and animal food processing, packing, and storage facilities. FSMA created the framework that holds manufacturers accountable for having a food safety plan, implementing it, verifying that it is working, and taking corrective action when it isn’t. Compliance dates are fast approaching for large food facilities. The human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and the animal food facilities must meet CGMPs by September 19, 2016. (The preventive controls rules have staggered compliance dates; smaller facilities have a year or more additional time to comply.)
One of the draft guidance documents covers ways to comply with the preventive controls requirements of the human food rule. Given the scope of that rule, we are prepared to issue only five draft chapters now, covering specific sections of the rule, but we will ultimately issue 14 chapters in all.
These initial chapters cover basic information about establishing preventive controls in a human food facility. The first chapter is about the food safety plan in which a human food facility outlines how it has identified and evaluated its food safety hazards and how it will control hazards requiring preventive controls. The subsequent chapters provide direction on conducting a hazard analysis; understanding the biological, chemical and physical hazards that are commonly of concern; identifying and implementing the preventive controls that will significantly minimize or prevent hazards; and managing the preventive controls through such actions as monitoring, corrective actions and verification activities.
The other two draft guidances when finalized will help domestic and foreign facilities comply with key requirements in the Preventive Controls for Animal Food rule, which covers all animal food, including animal feed and pet food. One of those documents provides direction on ways to comply with the rule’s CGMP requirements, which are baseline food safety and sanitation standards for animal food facilities. This draft guidance also provides information on provisions related to the CGMP requirements, such as qualifications and training of personnel.
While CGMPs have long existed for the production of human food, this is the first time that most animal food producers will be subject to CGMPs. Concerns about incidents of food contamination that were sickening and killing pets were among the driving forces behind the enactment of FSMA.
The third draft guidance when finalized will help domestic and foreign food facilities whose by-products of human food production are used as animal food. Such by-products include grain products and vegetable pulp. They also include foods like potato chips, baked goods and pasta that are safe to eat but considered the wrong size, shape, color or texture.
Food producers required to meet food safety requirements for human foods had been concerned that they would have to meet a whole new set of requirements for such by-products. The draft guidance makes clear that the by-product will only be subject to limited CGMPs to protect it from contamination during holding and distribution, if the human food facility is subject to and in compliance with FDA’s human food CGMPs and all applicable human food safety requirements of the Federal Food, Drug, and Cosmetic Act and implementing regulations and is not further processing the by-products for use as animal food.
If the human food facility is further processing the by-products, the facility has a choice of complying with the requirements of either the human or animal food rule, as long as the food safety plan addresses how the facility will prevent or significantly minimize the hazards for the animal food that require a preventive control.
These draft guidances, and the others that we’re working on for the FSMA rules, will be further refined based on input we receive from the public. The comments we received on the proposed FSMA rules were important in helping us shape the final rules so we look forward to working with stakeholders in the same way on these documents.
Meeting the FSMA mandate involves cooperation between the FDA and the food industry. From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.
Susan Mayne, Ph.D., is Director of FDA’s Center for Food Safety and Applied Nutrition
Tracey Forfa, J.D., is Acting Director of FDA’s Center for Veterinary Medicine