A Conversation with Jenny Murphy
The third major compliance dates will soon arrive for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). By September 17, 2018, facilities that are small animal food businesses must comply with preventive controls requirements mandated by FSMA. Facilities that are large businesses were required to comply by September 2017. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those with fewer than 500 such employees. The compliance dates for the Preventive Controls (PC) and Current Good Manufacturing Practice (CGMP) requirements are staggered for animal food companies. Facilities that are large and small businesses had to meet the CGMP requirements earlier -- by September 2016 and September 2017, respectively.
Also on September 17, 2018, facilities that are very small animal food businesses will be required to comply with the CGMPs. Very small businesses are those averaging less than $2.5 million per year in sales plus the market value of animal food they make or hold. These facilities are exempt from the full preventive controls requirements, but they have an additional year to meet the requirements applicable to qualified facilities.
Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explains what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PC Animal Food rule).
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?
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 a helpful foundation to have in place before you establish preventive controls. Feedback we have received during the first two years of CGMP inspections under this regulation has reinforced that we made the right decision to allow the industry to focus on CGMPs before implementing the preventive controls requirements.
Q: How are CGMPs different from preventive controls?
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 and physical hazards and the steps needed to eliminate or significantly 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?
This will be the first year in which all three business sizes (large, small, and very small) have reached at least one of their compliance dates. This will also be the first year in which we begin routine regulatory inspections to ensure compliance with the preventive controls requirements. For facilities that are large businesses, we will be conducting both CGMP and preventive controls inspections. For small and very small businesses, our focus this year is going to be on continuing to increase the level of oversight of CGMPs with more routine inspections.
Last year we delayed the start of routine regulatory inspections to ensure compliance with the PC requirements for large facilities to allow them time to develop, implement, and then fine tune their food safety plans. As we hit the preventive controls compliance date for small facilities, we recognize that both small and very small businesses would also benefit from additional time prior to the start of preventive control inspections. While facilities that are small businesses will be required to comply with the preventive controls requirements this September, we do not intend to conduct routine regulatory inspections to ensure compliance with those specific requirements until the fall of 2019. For facilities that are very small businesses, we intend to delay inspections for compliance with the provisions for qualified facilities until the fall of 2020.
Q: Why doesn’t the FDA intend to begin routine preventive controls inspections for facilities that are small businesses until next year?
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 continue to hear from animal food producers that they need more time and technical assistance to fully understand the requirements. We gave the larger facilities this additional time and now want to give the smaller facilities the same flexibility to further develop their plans and ensure that their system is operating correctly. Draft guidance on the preventive control requirements and other resources, such as technical assistance, are now available.
Q: Why are you planning to delay routine inspections rather than postpone the compliance dates for the PC requirements?
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 are protecting food safety while giving facilities additional time to make sure their system is working correctly and to make adjustments if needed. As we stated last year and intend to do this year, 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 facility 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?
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 recall and suspension of facility 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 because we intend to delay the start of routine preventive controls inspections by one year for each business size, we’ll be letting our guard down when it comes to keeping consumers, both human and animal, safe.
Q. Are there circumstances in which FDA will conduct a preventive controls inspection at a small facility over the next year?
Yes. There are times that FDA will conduct preventive controls inspections at facilities that are small businesses since they will have reached their compliance date in September 2018. What we are planning to delay is the start of routine regulatory inspections, which are mostly considered surveillance type inspections. When we become aware of a food safety problem and we need to conduct an inspection to further investigate the issue, we consider those inspections “for-cause.” This type of inspection is an important tool we use to carry out our responsibility for public health protection. Examples of when we may conduct a “for-cause” preventive controls inspection include if: there is a history of violative samples (product or environmental), the facility’s food is subject to a recall, the facility has made a reportable food registry report involving a potential hazard, significant observations were made during a previous inspection, and/or the facility is subject to enforcement actions taken by FDA or our state regulatory partners. This is not an exhaustive list, but it gives facilities an idea of the types of situations that may result in an FDA inspection.
Q: What resources are available for industry now and what are you still working on?
We’ve published multiple guidance documents, some draft and some final, to assist industry with implementing the regulation. We have final guidance on compliance with CGMPs and the small entity compliance guide. We’ve also published draft guidance on the hazard analysis and preventive control requirements, the supply-chain program, and 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, some of which have been jointly developed to cover this and other FSMA regulations.
In addition to guidance documents, 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 for understanding both the regulation and the scientific principles on which it’s based. Some groups in the animal food industry have also worked to develop and deliver training and other resources to help animal food companies develop a food safety plan and come into compliance with the rule.
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 as animal food need to know?
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 dairy. Our draft Guidance for Industry # 239: Human Food By-Products for Use as Animal Food explains the various scenarios and how the animal food requirements would apply to their by-product. In general, there are currently three different ways the regulation could apply to human food by-products.
The first one is for a by-product that is not further processed after it has been separated from the human food and the facility is complying with CGMPs and other applicable FDA requirements for their human food. In this case, the human food manufacturer is only further subject to limited requirements designed to protect the by-product during holding and distribution.
The second pathway was introduced through an enforcement discretion guidance and applies to human food facilities that are only doing certain manufacturing and processing activities performed on the by-products to facilitate transportation and storage after the by-product has been separated from the human food. Examples of the types of activities under this enforcement discretion are drying, chopping, and mixing. This means that under the enforcement discretion policy, the agency does not intend to enforce the preventive controls requirements in the PC Animal Food rule as they currently apply to these facilities and activities. That said, this enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards, or when these activities introduce animal food hazards. In addition, these facilities must continue to follow CGMPs for the manufacturing and processing activities they perform on the by-products after separation from the human food.
The last pathway is a situation in which the human food facility is performing more complex manufacturing and processing activities on the by-product, such as pelleting, after the by-product has been separated from the human food. In this case, the human food facility is subject to both the CGMP and PC requirements, but can choose to follow either the requirements in the PC Human Food or PC Animal Food rule for the processing and manufacturing of the by-product.
I want to note that as we pass the next compliance date in September, we intend to take the same inspectional approach for the by-products that we do for other animal food. Therefore, our plan is that timing of routine regulatory inspections of human food by-products will depend on whether the facility is a large, small, or very small animal food business.
Q: How does this impact the use of spent grains from the alcoholic beverage industry?
We continue to have an ongoing dialog with distillers and brewers who supply spent grains (the remnants of grains used to make alcoholic beverages) for use as animal food about the application of the CGMP and preventive controls requirements to their by-products.
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 as animal food, they are only required to follow the limited CGMP requirements designed to protect the by-product during holding and distribution.
Portions of this industry conduct some processing activities on their spent grains that are intended to facilitate transportation and storage, such as drying and centrifuging. These processing activities are not intended to significantly minimize or prevent hazards. We have previously stated that alcoholic beverage manufacturers processing spent grains must follow CGMP requirements for the processing, with the flexibility to follow either the human food or animal food safety standards, and that FDA does not intend to enforce the preventive controls requirements for the processing. That statement remains true. These facilities, and the types of processing they do on the spent grains, fall under the enforcement discretion for human food by-products outlined in our January 2018 guidance.
Q: What does this plan to delay routine inspections mean for animal food importers who must comply with the Foreign Supply Verification Programs (FSVP) rule?
FDA also intends to delay routine inspections of animal food importers. Unless an importer is exempt, the FSVP regulation requires importers of animal food to perform risk-based verification activities to ensure that their foreign suppliers are producing the food using processes and procedures that provide the same level of public health protection as those required under the PC Animal Food rule. For example, the importer is required to verify that its foreign supplier is controlling hazards by developing and implementing a food safety plan. The importer must also ensure the animal food is not adulterated.
Since FDA will begin conducting routine regulatory inspections of facilities that are large animal food businesses this year to ensure compliance with the preventive controls requirements of the PC Animal Food rule, FSVP inspections of importers whose foreign suppliers are large facilities will also begin this fall to ensure compliance with these requirements. In addition, FDA intends to delay FSVP inspections of animal food importers whose foreign suppliers are small and very small facilities until 2019 and 2020, respectively, to align with the planned delay in routine preventive controls inspections under the PC animal food rule.
Q: What is the best thing covered animal food facilities can be doing now?
For large facilities, you must have a good foundation with your CGMPs and an operational written food safety plan. You should have adjusted your food safety plan, if needed, over the last year and must have the appropriate recordkeeping to demonstrate your implementation of your plan.
For facilities that are small businesses, you must 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.
Facilities that are very 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 requirements applicable to qualified facilities. They must also be maintaining the records needed to establish that they belong in this category that receives the latest compliance dates.
Q: What is the ultimate goal?
Safe animal food improves public health overall. We’re protecting all the animals we feed, including family pets and animals 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.