When longtime food safety expert Roberta Wagner looks back on one of the largest food recalls in United States history, involving the Peanut Corporation of America’s salmonella outbreak some 15 years ago, she remembers how surprised many people were to learn there was a peanut butter recall involving that bacterium.

“How can it survive in this low moisture food?” she recalled of what some people found perplexing.

Wagner, who spent 28 years working for the US Food and Drug Administration (FDA) in a variety of roles, including associate commissioner for Food Safety Modernization Act (FSMA) implementation, said she has witnessed similar reactions to the idea that ice cream can become contaminated. The assumption, she explained, is that pathogens would be unable to grow in a freezer.

“Guess what, under the right circumstances, they can,” she said.

That’s just one example of why Wagner, now the senior vice president of regulatory and scientific affairs for the International Dairy Foods Association (IDFA), always tells dairy processors to make sure they are vigilant with controls – and making sure those controls are working as intended – inside of their facilities.

“I think for all dairy processors, keep up with the science,” she offered as one of her go-to pieces of advice for the industry. “What we see is foods we never thought would be a problem can become a problem.”

Of course, the dairy industry has seen through the years varying levels of listeria outbreaks tied to ice cream manufacturers. The presence of the same bacterium has led to some cheese recalls.


‘Dairy’s doing a really good job’

Focusing on Class I recalls, Wagner said the food safety and outbreak related issues dairy processors are most likely to run into are listeria in cheese (“every once in a while”) and ice cream, as well as salmonella with some dairy powders and whey proteins, and even ice cream at times.

“Those are the ones you typically hear about,” she said of Class I recalls. “Press releases have to be issued. It’s very, very public.”

Undeclared allergens are another primary concern in that realm, with the FDA listing milk as one of the nine major food allergens. Labeling requirements have to be met with every product that goes out to consumers, and if they aren’t for any reason, Class I recalls related to undeclared allergens will follow.

Dairy processors also must be on the lookout for cross-contact contamination.

“If you’re making a product in a facility that contains both milk and then non-milk, sometimes there’s not a sufficient clean in between the two (production runs),” Wagner gave as a representative case.

Such a scenario could lead to an issue in which a product labeled as non-dairy contains traces of dairy, and as a result would have the potential to cause someone who is allergic to dairy to become ill.

“They’re probably more prevalent than any of the pathogen related recalls,” she said of cross-contamination snafus. “I think dairy’s doing a really good job. They’re few and far between, quite frankly.”

Another potential issue exists with post-processing pathogen contamination. Wagner said if a dairy processor addresses pathogens for a product before it is packaged and the product then encounters some exposure to the environment, the time between applying a control for the pathogen and packaging the product must be scrutinized. Otherwise, some unwanted element could be introduced during that transition period.


Managing outbreaks and recalls

Once FSMA was established in 2011, Wagner noted, the law required all food and beverage manufacturers to create a recall plan, with specific checkmarks to hit along the way.

Food processors must comply with the Preventive Controls for Human Food Rule, which not only requires companies to establish and implement safety systems that include an analysis of hazards and establishment of preventive controls, but also gives them the details of how to prepare for the chain of events that accompany a recall.

“There’s very specific things that need to be in there,” Wagner said of a recall plan. “There’s a whole chapter in a guidance document on recall plans and what a good one looks like and how to meet the requirements.”

Any company that doesn’t have such a recall plan in place would be considered non-compliant.

Establishing the required plan is the bare minimum measure a company should take, Wagner said. She recommended dairy processors also take the initiative to follow through with much more preparation.

“Actually doing mock recalls and implementing that recall plan, I think, is really important,” she advised. “It’s not something that’s mandated. But a lot of companies do that.”

Preparing for the worst can prove to be a crucial preventative action, she said, endorsing periodic exercises that make people at a company familiar with all the details of managing a recall response.

The plan should include who is responsible for handling specific requirements within the process, she added, and can include elements such as model recall letters that have to be sent to any other entity within the supply chain that received the product.

“They give you a lot of responsibility, but I would say the more specific the recall plan, the better,” Wagner said.


No time to dawdle

If a processor encounters the misfortune of recalling a product, Wagner strongly advised acting with urgency.

“The longer it takes you to do things like call the FDA, provide them with the information that you’re required to provide to them, the more they’re thinking you don’t have your act together,” Wagner warned.

Looking back at her long tenure at the FDA, she said a lack of swiftness would make her suspicious and lead her to think someone from the FDA needed to visit the facility from which the recalled product originated.

The primary reason to give a recall response top priority is to keep a potentially dangerous product out of consumers’ pantries and refrigerators. Wagner said the majority of recalls are not associated with an outbreak, but even if a company is recalling a product as a precaution, acting with urgency should be a prime concern.

And she said the majority of companies take that approach. Through her years of working with the industry, Wagner discovered that companies often execute on a recall before the FDA has even officially classified it.

“If they know it’s likely a Class I situation because they can look at past precedent, what the agency has recalled, they just act,” she said. “They want to make sure they’re being protective of consumers.”

She also encouraged companies to not wait around to find their key contacts at the FDA. Wagner has told IDFA members to be sure they identify the FDA recall coordinator for each of their facilities. If a larger company operates plants in different states, it’s likely that it would have to deal with different coordinators, depending on the location of the outbreak.

“Make sure you know who those people are, and that list is always current,” she cautioned. “Introduce yourself, do a quick call. It’s better to develop that relationship before you’re in a crisis situation.”


‘Continual improvement’

While dairy products are inherently different than other ready-to-eat foods, it doesn’t make going through an outbreak or recall response different for dairy processors.

Just like any ready-to-eat food maker, a dairy processor reacting to a recall or outbreak will have to examine the operation at the facility where it occurred and determine exactly what went wrong.

Any time a Class I recall becomes necessary, Wagner explained, a company needs to reassess its food safety plan, identify where the blame lies and put solutions and/or corrective actions in place to prevent the recurrence of that type of event.

“FSMA is all about continual improvement,” she said. “I think recalls are an opportunity for industry to learn.”

The first thing a company involved with a recall has to do is get products off retail and digital e-commerce shelves, and out of homes. But Wagner said assessing the specifics of what went wrong should be concurrent with that.

“Why did this happen? And then think about what kinds of controls are needed or corrections to beef up the food safety system and make sure it doesn’t happen again.”

Thorough evaluations of this type can become immediately beneficial, as well. Wagner explained that while responding to a recall, being forthcoming with information for the FDA can help the process along.

“One of the biggest problems when I was at the agency was getting facilities or companies to clearly articulate how and why they scoped the recall,” she shared. “How did they make the determination of what was in versus what was out?”

If a facility deals with cheddar cheese that is made every day, she offered as an illustration, it must be determined how many days of production need to be part of the recall – that’s where batch and lot numbers come into play – and a company has to be able to explain why just a couple of days are in a recall but not a whole month.

“And it needs to be risk-based, science-based,” Wagner said of the explanation.

When she worked at the FDA, she said one of the biggest roadblocks the agency encountered was coming across companies that couldn’t tell the agency how that determination was reached.

A facility should be able to identify a clean break in the production, show that a complete clean of the facility happened on a given day or be able to pin down another factor, such as a corrected labeling issue, that accounts for the product range, Wagner said.

“Make sure you can explain that very clearly, as to how you’re making those judgments.”