The second major compliance dates will soon arrive for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal feed facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016.

Also on this date, small animal food facilities – those with fewer than 500 full-time equivalent employees – will be required to meet the CGMPs; they have an additional year to meet the preventive controls requirements.

Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, recently explained what animal feed producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. 

Q: In the preventive controls for human food rule, companies had to meet the preventive controls and CGMP requirements at the same time. Why is CGMP and preventive controls compliance staggered for animal food companies?

JM: For animal food, both the CGMP and preventive controls requirements are new. Animal foods have been regulated for years at the state and federal levels in various ways, including provisions for medicated feed, labeling and adulteration. But this is the first time that there’s been this kind of comprehensive oversight on the preventive side and we did not have the longstanding CGMPs for animal food that we did for human food. During the rule-making process, industry requested that we stagger the compliance dates, and we agreed that it would make sense to give them a year to focus solely on CGMPs. CGMPs are the foundation that must be in place before you establish preventive controls.

Q: How are CGMPs different from preventive controls?

JM: CGMPs are more basic; they’re things you would do in the course of normal business, like proper cleaning, pest management, and maintenance of equipment. I would say the CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern. Once you have CGMPs in place, 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.  You can determine where you need to make sure your process can and is controlling a hazard. What do you need to monitor? Where do you see possible problems and how will you respond?

Q: What happens next in terms of FDA enforcement of these new requirements?

JM: There will be an increased level of oversight of CGMPs with more routine inspections because, as of September 18, both large and small facilities will be required to meet those requirements. What large companies, those with more than 500 full-time employees, need to know is that they are also required to meet the preventive controls requirements, but we will not be conducting routine regulatory inspections to ensure compliance with those specific requirements until the fall of 2018. There will still be CGMP inspections, but not those looking at preventive controls for now.

Q: Why won’t the FDA begin routine preventive controls inspections until next year?

JM: Throughout the rule-making process, the FDA has repeatedly said that we will educate before, and while we regulate. This is new territory for all of us and we have heard from animal food producers that they need more time and technical assistance to fully understand the requirements. We want to give the larger facilities some flexibility to further develop their plans and ensure that their system is operating correctly as guidance from FDA and other resources are put in place.

Q: Why doesn’t the FDA just postpone the compliance date for preventive controls?

JM: We really feel that the preventive controls provisions are in the best interest of public health. The responsibility is on the firm to make sure it is addressing animal food safety. By keeping the compliance dates but not beginning routine regulatory inspections, we’re protecting food safety while giving facilities additional time to make sure the system is working correctly and to make adjustments if needed. If we find a problem for a facility that has reached its preventive controls compliance date, we will be looking at their food safety plan to see what controls they have outlined. We will be in their facilities to address CGMP compliance, and can work with them to make sure they’re providing that next level of protection.

Q: Does the focus on education mean that companies that don’t follow safe practices won’t really be held to account for another year?

JM: No. Our job is to protect public health. If there is a problem, whether it’s a potential or actual food safety hazard, we will use the tools available to us to keep that food out of the marketplace. FSMA strengthened our authorities to include mandatory recalls and suspension of registration to block a facility’s ability to distribute food. This is an important message to get across. We don’t want people to think that by not beginning preventive controls inspections we’ll be letting our guard down when it comes to keeping consumers, both human and animal, safe.

Q: What resources are available for industry now and what are you still working on?

JM: We’ve published draft guidance on compliance with CGMPs and a small entity compliance guide. We’ve also published guidance on the use of human-food byproducts as animal food. There are other guidances available that are specific to certain provisions in the rule or sectors of the industry. What we’re still developing is guidance on the hazard analysis and preventive controls requirements.  We are working to get that out as quickly and efficiently as possible.

In the meantime, there are other tools available to help animal food producers create their food safety plans. For example, take a look at the training available through the Food Safety Preventive Controls Alliance. That provides a good foundation in both the regulation and the scientific principles on which they’re based.

We also have the FDA FSMA Technical Assistance Network available to provide answers to questions that arise.

Q: What do producers of human food who supply by-products for use in animal food need to know?

JM: They should first understand the extent to which the animal food rule applies to their by-products and that depends on the activities they are performing. By-products used for animal food can include materials such as those generated from processing fruits, vegetables, grain and wheat. Our draft Guidance for Industry # 239:  Human Food By-Products for Use as Animal Food explains the various scenarios and how these requirements would apply to their by-product.

In general, if the by-product is not further processed and the facility is complying with applicable FSMA requirements, the human food manufacturer is only further subject to limited requirements designed to protect the by-product during holding and distribution. Processing the by-products – for example, by grinding or drying them – could make manufacturers subject to both CGMPs and preventive controls requirements for these products, although they can choose to follow either the human or animal food rules.

I want to note that as we pass the compliance date in September, we will take the same inspectional approach for the by-products that we do for other animal food manufacturers and will not be conducting routine inspections for compliance with the preventive controls requirements until the fall of 2018.

Q: How does this impact the use of spent grains from the alcoholic beverage industry?

JM: This has been the subject of a lot of concern for the distillers and brewers who supply the spent grains (the remnants of grains used to make alcoholic beverages) that have long been used in animal food. They worried about possibly being required to meet the CGMP and preventive controls requirements established for both human and animal foods.

As with the producers of other human food by-products, if the distillers and brewers are following CGMPs for their human food (e.g. alcoholic beverages) and are not further processing the by-products they’re providing for use in animal food, they are only required to ensure that the by-products are properly labeled and kept safe from contamination.

The difference here is that the implementation of preventive controls requirements is being handled differently.  If they are processing the spent grains, these makers of alcoholic beverages must follow CGMP requirements, with the flexibility to follow either the human food or animal food safety standards. FDA has been meeting with this sector of the industry and, as we work through this issue, has agreed to not enforce the preventive controls requirements for the processing of the spent grains.

Q: What does this delay in inspections mean for foreign firms whose importers must comply with the Foreign Supply Verification (FSVP) rule?

JM: Under the FSVP rule, importers of animal food must verify, among other things, that their foreign suppliers produce food using processes and procedures that offer the same level of public of public health protection as is provided by the preventive controls rule. For example, the importer is required to verify that its foreign supplier is controlling hazards by implementing a food safety plan.  However, because the FDA is not yet beginning inspections of animal food facilities to ensure compliance with preventive control requirements, the agency will also not begin FSVP inspections for animal food importers until the fall of 2018. This way the start of the FSVP inspections for these importers will be aligned with the start of preventive controls inspections for animal food.

Q: What is the best thing covered food facilities can be doing now?

JM: For large facilities, you should already have a good foundation with your CGMPs, should have your food safety plan in place, and be working on recordkeeping to document the steps you’re taking to implement your plan. You should make sure that your employees understand what’s required and why. Small businesses should have their CGMPs in good working order and be looking to the future and what they will have to do to meet the preventive controls requirements. They should be thinking about their food safety plans and where there may be hazards. Don’t wait until the last minute. Start thinking: What training do we need? What may we have to adjust in our work processes to meet these standards? For very small businesses, even though their CGMP requirements don’t come until 2019, they also need to look to the future and, in the meantime, be maintaining the financial records needed to establish that they belong in this category that receives the latest compliance dates.

Q: Where can companies go wrong?

JM: Companies can go wrong by not doing what they’re supposed to do; by not doing what this animal food rule requires. FSMA was passed by Congress with support from industry, consumer groups and regulators and provides the foundation for food safety far into the future. This is not about facilities trying to do the minimum that’s required but to use this as an opportunity to showcase their own food safety culture. The animal industry as a whole does a very good job, but this is an opportunity for improvement.

Q: What is the ultimate goal?

JM: Safe animal food improves public health overall. We’re protecting both the animals we love and those that enter the food supply. At the end of the day, the FDA and the producers of animal food are on the same page: We all want safe food. But I understand that these requirements can be overwhelming and that’s why we’re focusing on education right now. My mantra has been that in five years, it’s going to be a different conversation. We won’t simply be talking about what we have to do to implement FSMA.  Instead, we’ll be able to say: Here’s the food safety framework. Here’s what we’re doing to keep food safe. And we’ll all take pride in that.

Further information: Food Safety Modernization Act and Animal Feed