FSMA Fridays: The Food For Animals Rule (Part One Of Four)
Safety Chain’s Barbara Levin discusses FSMA’s Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Rule with the Acheson Group’s Dr. David Acheson, Jennifer McEntire, and Ann Sherod
On the last Friday of every month, Barbara Levin of Safety Chain, a leading provider of food safety and quality assurance automation and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group. In the most recent installment, the panel discusses the new food for animals rule. This is a transcript of the January 31 pod/webcast. The only items not included in this article are warm-up conversations and segues in the discussion.
Barbara Levin: Ann, I am going to start with you. In regards to the Current Good Manufacturing Process and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals Rule, can you give us a big picture of what companies are going to have to do and maybe chat a little bit about how similar these requirements we think are going to be to the human food rules?
Ann Sherod, Director of Food Safety with The Acheson Group: This proposed “The Animal Rule” establishes new good manufacturing practice (GMP) provisions for animal producers for animal feed and food. The companies will have to implement those GMPs, and those GMPs are similar to the human rules, such as buildings and facilities, design and layout, cleaning and maintenance, and pest control.
In addition to these new GMPs, facilities will have to develop food safety plans similar to the human rule. They will have to include a hazard analysis. For those hazards that they deem as reasonably likely to occur in their particular facilities, they will have to develop appropriate preventive controls and those preventive controls will be to significantly reduce or minimize or prevent those hazards from occurring.
Similar to the human rule, facilities will have to monitor those preventive controls to ensure that they're consistently performed and develop corrective actions. Those corrective actions will need to be properly implemented and in case that there's an unanticipated problem, you'll have to have a plan on how you would react to that as well. You will also be required to conduct forms of verification, validation of your preventive controls, verification that the monitoring of those preventive controls is being conducted, and also that you're conducting a reassessment of your food safety plan. And then, if there are any corrective actions that you are doing, that you're following up on those from a verification perspective. In recordkeeping, you just need to make sure that you're keeping the appropriate records. I believe this rule is similar to the human rule — there's a two-year requirement for those records.
It seems there are a fair amount of similarities between the preventive controls and some of the other rules that have come out. Jennifer, who’s going to have to comply with this rule? Can you give us a definition that, in terms of this rule, what is animal food and maybe talk about manufacturers of ingredients for livestock feed? Do we need to do anything differently than those producing foods for our pets?
Jennifer McEntire, Ph.D., Vice President and Chief Science Officer for The Acheson Group: This rule applies to FDA registered facilities. Those are facilities that manufacture, process, pack, or hold animal food. Though, there are some exceptions. If a facility is producing a low-acid canned food, that low-acid canned food is exempt. If they are just holding packaged animal food, animal food, that doesn't require any temperature control, they don't need to do all the things Ann was talking about. If there is temperature control that's required for the finished food product, then again, similar to the human food, they just need to make sure that they're monitoring temperature.
The rule does apply to pretty much anybody else who has something to do with animal food and is an FDA registered facility. The term Animal Food encompasses a few different types of foods: pet food, food for captive animals, animal feed, and all ingredients of those finished products. In terms of ingredients for livestock feed and pet food, they all will need to comply with this rule. The FDA hasn't really made a distinction between the ingredients versus finished food product, between animal feed versus pet food, but they're all covered under this rule.
Very across the board, then. Great, thank you. Ann, let's go back to you. How are current good manufacturing practices for animal food and feed different from those versus for human food?
Ann: First, this establishes new good manufacturing practices for animal food and feed which is different from the preventative controls for human food because those were enhancements and updates to current good manufacturing practices for human food. Jennifer set the stage by saying all of those particular establishments that are required to be registered and do not meet an exemption to this rule will need to implement good manufacturing practices. For example, hygienic practices, facility operations of maintenance and sanitation, good equipment and utensil design, and maintenance of that equipment, process controls, and warehousing and distribution, to name a few.
Some of those good manufacturing practices that do not apply would be anything that may not be applicable to animals, and in this case, the difference would be the cross-contact of allergens. That is identified as something that is not a risk when producing pet food or animal feed, that it is for human production of food.
In FSMA Fridays: The Food For Animals Rule Part Two, Levin and the panel will discuss what happens when facilities produce human food but some of the waste goes to animal feed. Additionally, the group will address the FDA regulations and GMPs involved when a human food company diverts to animal feed processing. Stay tuned.
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