Although animal foods had previously been regulated at the state and federal levels in various ways prior to FSMA, the regulation heralded new mandates for preventive controls and adherence to GMPs that did not previously exist for animal foods — including pet food. Most pet food manufacturers followed the guidance of the American Feed Control Officials (AAFCO), however AAFCO had no legal authority over the food or its manufacturers.

With FSMA’s Preventive Controls for Animal Foods Rule, animal food became subject to federal regulation holding it to the same standards as human foods — for the first time. This included adherence to GMPs and the development of a written Food Safety Plan that included a hazard analysis and risk-based preventive controls to minimize or prevent the hazards.

The new rule has had a significant impact on the animal foods sector, particularly smaller businesses. But, like many human food facilities, some larger pet food manufacturers had implemented HACCP prior to the advent of FSMA, so were well-prepared for the transition. As explained by Nestlé Purina PetCare Vice President of Quality Assurance Chris Archer and former Director of Food Safety Richard Driggs (now Zanesville, Ohio, factory manager), “Our comprehensive approach to food safety was well established ahead of FSMA, embracing the principles of HACCP, and we remain committed to continuous improvement. Our company was founded with safety as one of its key principles nearly 100 years ago. To this day, food safety remains our highest priority.”

To further Purina’s perspective on the rule and the transition, QA conducted a Q&A with the two.

QA: What were your thoughts when you became familiar with the PC/Animal Foods Rule?

Purina: The implementation of FSMA has helped further raise the bar for pet food safety, and that’s a good thing for pets, pet owners and pet food makers. To members of the Pet Food Institute (PFI), representing 98% of U.S. pet food, food safety is not a competitive advantage. Industry-wide, the more compliance we see, the better the outcome for all involved.

QA: What changes did Purina have to make for compliance?

Purina: The biggest changes we saw focused more on consistent terminology, points of emphasis and really standardizing the regulations. It helped create a baseline of understanding for our team and others in the industry. PFI and the National Grain and Feed Association (NGFA) were instrumental in education and implementation; we’re grateful for their leadership.

QA: Included in the rule are requirements for a written Food Safety Plan and a preventive controls-qualified individual. How did this impact your existing programs?

Purina: The new rule meant building on existing competencies. Purina’s quality assurance and safety protocols are some of the highest in the pet food industry, and we hold ourselves to very strict standards. The introduction of Prevent Controls Qualified Individual (PCQI) certifications was important to establish and implement the specifics of FSMA, outlining a well-defined process which simplified and focused our HACCP critical control points. Hundreds of our Purina associates completed the PCQI certification to ensure that each of our manufacturing facilities across the U.S. has multiple certified associates at any given time. A few of our team leads even became lead instructors so that we could bring the training into our locations and complete it efficiently.

QA: What impact do you see the PC for Animals Food Rule having had on animal/pet foods in general?

Purina: The most significant impact was to raise the food safety bar for the entire industry so that pet owners can have confidence in the products they feed their beloved pets. With the leadership of PFI, as an industry we were able to raise the bar for everyone and provide tools and trainings required for greater compliance and better overall food safety standards.

QA: What do you see as the most positive industry impacts of the rule? Are there any negatives?

Purina: The introduction of FSMA not only established a high bar for food safety, it also nurtured deeper understanding from regulators so when state and federal inspectors conduct site visits, there is now a clear vision of what is being observed and what it means in relation to the established rules. FSMA defined what modern food safety should look like, which is important so that all parties involved remain focused and committed to collectively keeping pet food safe.

There’s no need to cry over spilled milk. But melted ice cream? That’s another story.

One of the central ideas behind FSMA was to try to cover as much of the food supply chain as possible. From the Produce Safety Rule, to both Preventive Control rules and the rules regarding foreign suppliers, the regulation puts controls into many nodes in the chain.

But what good is it all if the way everything from raw ingredients to finished products are transported isn’t safe as well? Enter the Sanitary Transportation Rule, which covers road and rail transportation within the U.S. (If a foreign product is not intended for U.S. consumption or only travels through it from one country to another, it isn’t regulated under this rule.)

“FSMA really hit the manufacturers hard, and they put a lot of systems within the plant,” said Brian Hammer, senior transportation consultant at Nationwide Insurance, who deals with carrier drivers. “There was a good realization that, ‘Hey, we can do everything right here within our four walls, but all of the sudden it’s going to go in the four walls of a trailer down the highway, and there are a lot of things that could happen to that food in route.’ ”

Key requirements of the rule include design and maintenance of vehicles used to ship food and measures taken during transportation such as temperature controls and preventing contamination between products. Training in these areas and records of procedures and agreements are included as well.

Hammer gives us insight on some of the rule’s ins and outs, and how everyone can help each other stay compliant.

QA: It seems like this rule is really about making sure there’s good written and verbal communication between shippers, loaders, carriers, receivers and brokers. What tips can help make sure this communication happens?

BH: The shipper should provide the requirements so the carrier can follow a checklist of everything that carrier needs to do. But there is certainly a big issue with the communication between shippers and drivers. There’s always communication between the shippers and the carrier. But sometimes it’s lacking when that driver shows up to the facility. One of the things I think happens most is that requirements may have been communicated to the carrier, but a lot of that information is best given to the driver. The carrier has an obligation to make sure their driver knows the requirements, but if you can’t help educate the driver while he’s there, that’s an issue.

QA: Did the COVID-19 pandemic throw a wrench in that by limiting in-person communication?

BH: If you talk to drivers, there’s a real concern there that shippers don’t talk to anybody in the truck anymore. First of all, drivers want to make sure it’s properly loaded. Because some of the issues with food safety could be that the freight bangs against itself, and it opens up a container — now that food is exposed. Load security used to be a driver’s responsibility. But now drivers aren’t allowed back there, and they can’t inspect it until they drive away. Those drivers are simply not on the dock anymore.

QA: For several FSMA rules, FDA provides training on many of the controls and requirements. Is that the case here as well?

BH: It’s more generic, and it doesn’t drill down to some of the real important things that may or may not be part of what you haul. Allergens are a perfect example. If they don’t wash that trailer after [hauling peanuts], as per regulation, they could cross contaminate the next load they haul, which could be some sort of vegetable. Some of that was not really laid out. It’s a good start, but I would suggest to some companies, you need to add that training. The regulation says you need to train to the specific requirements that the customer has.

Proposed in July 2013 and finalized in November 2015, the Foreign Supplier Verification Program (FSVP) and Accredited Third-Party Certification Program rules of FSMA both focus on foreign production of food intended for consumption in the U.S. However, the two differ in significant respects: While the Third-Party Certification Rule establishes a voluntary program for third-party food safety auditing of foreign entities, the FSVP Rule not only sets requirements for a U.S. entity’s review of its foreign suppliers, but violations of it topped the list of FDA noncompliance inspection observations in 2020.

FSVP.

To ensure that food produced outside the U.S. meets the same food safety standards as those produced domestically, the FSVP Rule requires that importers verify that suppliers’ food production “provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate.” It also requires that a foreign supplier’s food be verified as not adulterated and not misbranded with respect to allergen labeling.

The rule has been in effect since 2017, although during the pandemic, FDA has temporarily conducted remote inspections by requesting that importers send the FSVP-required data to FDA electronically (or by other prompt means). But even having had three years to get records in order, the industry’s top noncompliance on FDA’s 2020 Inspection Observations was the non-existence of an FSVP. Along with the complete lack of development of an FSVP, the observations include not maintaining or following an existing FSVP, and not providing assurances that the foreign supplier follows processes and procedures that provide the required level of public health protection.

But getting a tick mark on an inspection observation for lack of an FSVP is only the tip of the issue, as the U.S. Customs and Border Protection (CBP) can — and will — reject food entries that do not have the required FSVP documentation data.

Accredited Third-Party.

With all the FSMA rules and requirements a food facility needs to understand and follow for compliance, why would a business add a voluntary program to the list? In this case, it would be to enable the company’s imported foods to jump the line.

That is, the certification attained through the program establishes eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review entry of food. Participation in VQIP requires that all the food facilities for which the company wants expedited entry of foods have a food safety certification from an accredited third party and implement other measures that “support a high level of confidence in the safety and security of the food they import.”

The FDA-recognized accreditation bodies (of which there are currently four) have the responsibility of accrediting the third-party certification bodies, of which there are 12. (See the FDA dashboard for the lists.)

As one might suspect, there is an FDA fee for this benefit, currently set at $17,000 per year, as well as fees for the accreditation itself. With all this, only three companies are currently listed as participating in the program: Costco Wholesale Corp., Pacific Seafood Co. and Sovena USA.

While the rule is primarily voluntary, it is important to note that, in specific circumstances, FDA can require that a food offered for import be accompanied by a certification from an accredited third-party certification body.

A leafy green E. coli outbreak made headlines again late in 2020, but it was the 2006 spinach outbreak that left 202 people ill, resulting in three deaths, that paved the way for FSMA’s Produce Safety Rule, also known as Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption. As a result of that outbreak, California farmers formed the California Leafy Greens Marketing Agreement, which aimed to put more responsibility on farmers for the safety of the products they produce.

“It was the first time that there were auditable metrics put on the growing side of the produce world beyond just regular USDA gap audits,” said Will Daniels, president, produce division at IEH Laboratories and Consulting Group. “This was more focused on controlling for food safety and the hazards that may exist on farms.”

Daniels, who worked at Earthbound Farm as chief food integrity officer at the time of the recall, said that agreement inspired a similar one in Arizona since parts of the industry move there during the winter. Much of what was included in the agreements — monitoring irrigation water and soil amendments and requiring growers to have food safety professionals on staff — are also part of the FSMA rule. And while FDA spent a lot of time talking to growers and getting input, many of the controls still aren’t entirely welcomed.

“If they don’t understand the risks and see that there’s a problem, then it’s just a cost,” Daniels said of some farmers and growers. “Most farmers are farmers because they don’t want to talk to people. They don’t want regulation.”

But, he stressed how important these controls are to overall food safety.

“You don’t have food safety unless you have control from farm to fork,” Daniels said. “Everybody has to pay attention. And so that’s really what FSMA is doing. … Everything you grow should be as safe as it can be.”

That being said, there have still been multiple outbreaks associated with leafy greens since the agreements and signing of FSMA. That fact is one of the reasons Daniels believes FDA is still working on one of the largest components to the Produce Safety Rule, agricultural water.

“It’s one vector of several that can contaminate,” Daniels said. “So, it’s not the end all, be all, but it’s one of those areas of risk, and that’s why there’s such a hold up on it. My guess is that they’ll probably have something out this year.”

Essentially, this part of the rule is set up to make sure water used in irrigation and other farming processes doesn’t have E. coli or other pathogens. The runoff from grazing fields is one potential source of contamination.

“If you’re using irrigation from an open water source, that being a canal or a reservoir, you have to treat that water before it goes out in the field,” Daniels said. “An irrigation event could be thousands of acre-feet in a field. A lot of water.”

And, Daniels noted, there’s still debate on how contaminated water leads to a crop that actually makes people sick.

“There are folks that believe that there’s potentially uptake of the plant roots of contaminants that can lead to ill consumers, but studies show that the plants natural defenses will eliminate the pathogen in a few days,” he said. “We know that radiation reduces surface contamination if its on the outside of the plant if allowed enough time.”

Another part of the rule that Daniels said needs continued focus is soil amendments. The industry, he said, relies on soil amendments that come from animal sources such as cow and chicken manures, fishmeal and more. For many farmers, it represents a win-win of fertilizing crops and eliminating a waste stream.

“However, it does come from sources that are pathogenic,” Daniels said.

While the leafy greens amendment, and subsequently FSMA, include controls that require a COA saying soil amendments are free of pathogens, that’s about as far as it goes.

“I don’t feel that just asking for a COA for that particular lot that’s being delivered is enough.” Daniels said. “I think we need to go back to those suppliers and ask for more control from them.”

At the end of the day, Daniels said FSMA’s Produce Safety Rule should help nudge growers to look at their food safety plans and programs and give them more insight into the processing side of things, bringing the entire industry closer together on the idea of food safety.

For example, a grower can do everything right, but if somebody at the production facility ignores a control, or a trucker allows product to be unloaded and left on a dock exposed to the elements, or a retailer displays bagged salads in an unrefrigerated island, any one of those acts could lead to an ill consumer.

“FSMA is forcing all sectors of the supply chain to better understand the impact and the responsibility they have in food safety,” he said. “It helps processors understand the risks on the growing side.”