U.S. Apple Industry Gears Up to Comply With FDA’s FSMA Rules

“An apple a day keeps the doctor away,” is more than a well-known saying — it’s also what many people believe to be time-tested truth. And the tradition of giving an apple to a teacher on the first day of school also says something about the apple’s solid reputation for being healthy and tasty.

In the world of food safety, fresh apples had long been a shining star with no foodborne illnesses connected to them. But that changed last year when caramel apples were linked to a 12-state outbreak of Listeriosis, a potentially fatal foodborne illness.

That outbreak put 34 people in the hospital and, before it ended, seven of them were dead, with Listeriosis blamed for at least three of those deaths.

At first, the assumption was that the problem must be in the caramel used to coat the apples, or somewhere in the process of coating the apples with caramel. After all, people don’t get sick from eating fresh apples.

But an on-site investigation last January of Bidart Bros., the apple source for those contaminated caramel apples, revealed Listeriapositives on polishing brushes, drying brushes, a packing line drain, inside a wood bin, and on an automatic line.

According to results of the investigation, federal and state inspectors “observed direct food contact areas of packaging equipment, used during the 2014 apple season, constructed and/or maintained in a manner so that they cannot be properly cleaned.”

Those results led the California company to voluntarily recallall of the Granny Smith and Gala apples processed in 2014 through their cooler-packing facility, and consumers were advised to toss any varieties supplied by Bidart.

Three distributors of caramel apples had already recalled their caramel apples in response to the outbreak.

All of this came as a shock to the apple industry, which prides itself on being ahead of the curve when it comes to food-safety practices. It also reinforced how important food safety is in the global marketplace, where one of every four apples grown in the U.S. ends up.

Asia reacts

Christian Schlect, president of the Northwest Horticultural Council, told Food Safety News that growers and packers suffered an economic blow when buyers in some Asian countries learned about the recall. Asian countries, including Japan, India and Taiwan, account for a large share of U.S. apple exports.

In a recent article in Good Fruit Grower, Schlect wrote that when the U.S. Food and Drug Administration (FDA) notified several foreign buyers that the “unsafe” apples might be in their local markets, some Asian countries temporarily restricted access for all U.S. apples — not just those supplied by Bidart Bros., which Schlect said had “limited export sales.”

Some of those countries required apples from the U.S. to be tested for Listeria monocytogenes at the border, and some even sent media outlets warnings about the dangers of U.S. apples.

Until the overblown fears subsided, growers and packers were hit with falling sales, which, in turn, resulted in falling prices. Schlect described that as the natural fallout when shipments are turned back and orders stop coming in.

“No doubt there were substantial damages to the industry,” he noted. “The growers and packing sheds that suffered financially won’t be able to recover their losses. There’s no one to sue.”

In an email to Food Safety News, Anne Morrell, food-safety coordinator at Hansen Fruit Company in Yakima, WA, said that the company exports a large portion of its apples to Asia.

“Our Asian customers were hearing wildly inaccurate rumors about the safety of Washington apples due to inaccuracies in translation,” she said.

Worse yet, the apple industry was also suffering from a port slowdown on the West Coast and from the Russian ban on U.S. produce.

“It was a perfect storm to drive apple prices down below the cost of production,” Morrell added.

The push from retailers

Morrell, a member of of the Northwest Horticultural Association’s Food Safety Committee, said that the tree-fruit industry is ahead of others when it comes to food safety, in large part because of pressure from retailers.

Around 2007, the large retailers, such as Walmart, Costco, Safeway and Kroger, began requiring packing houses to have third-party food-safety audits.

“Our industry organizations predicted it was only a matter of time until orchard-level audits would also be required, so they began helping growers become compliant with USDA’s Good Agricultural Practices and Global Good Agricultural standards,” she said. 

That prediction came true in 2010, she said, when Walmart announced it would require farm certification and the other retail chains followed.

“As a result, even small tree-fruit growers have food-safety programs, so most of the requirements of the Food Safety Modernization Act will not be hard to achieve,” Morrell said.

Mike Carter of Wisconsin-based Housman’s Inc. told a reporter from The Packer this past March that his company has been audited by a third-party auditor for the past eight years “not because we had a food-safety issue, but the customer base wanted to do business with someone who could evidence that they had it under control,” he said.

Carter said his company’s food-safety and traceability requirements are nothing new. In fact, the company has had food-safety protocols in place for “a number of years.’”

“Our industry is largely in compliance for what is likely to appear once the regulations are released late this fall,” he said.

Warren Morgan, a Washington state orchardist and owner of Double Diamond Fruit in Quincy, WA, which annually packs about 2 million boxes of apples, cherries and apricots, previously told Food Safety News that as farming operations become larger, there’s more risk of cross-contamination, which is why following food-safety practices becomes increasingly important.

He explained the nitty-gritty realities of the challenge this way: “Pathogens are doing their best to make it into our buildings, and our job is to beat them back as best we can.”

Challenges ahead

As proactive as the tree-fruit industry may be, there are plenty of challenges ahead. Not surprisingly, proposed water-quality standards designed to make sure that the fruit isn’t contaminated during the growing or packing processes have raised concerns. Testing and record-keeping is also part of the mix.

A top concern for apple growers are the proposed standards for water that touches the fruit. Morrell said that most apple orchards are irrigated with under-tree systems so, under normal irrigation, water doesn’t touch the edible fruit.

But when the hot weather hits in July, August and September, apple growers use overhead sprinklers to apply water to the tops of the trees to cool the fruit off. As the water evaporates, the fruit cools down. The spraying also protects the apples from sunburn. Then, too, the cooling promotes the development of red color, a definite plus in the marketplace. Morrell explained that pigments that turn the apples red are destroyed by heat, which is why cooling the apples off is so important.

According to the proposed food-safety rules, water that will touch the edible portion of the crop will need to be tested throughout the season for bacteria. The problem there, Morrell said, is that the growers would need to take a water sample from the tests to a commercial lab within 24 hours of the time it is collected. No easy task since the labs are often located far from the orchards.

From there, the grower would need to put the results of those tests into a complicated formula to determine whether the bacteria levels are too high to apply the water to the fruit.

Morrell said that if growers are required to stop evaporative cooling, as much as 30 percent of the apples would have to be culled due to sunburn and less-intense red color.

“Less color means fewer of the apples would be packed at premium grades, which would be a big financial loss to the grower,” she said, pointing out that that’s why growers are waiting to see whether the final FSMA Produce Rule, expected to be finalized this month, modified the originally proposed microbial standards and testing requirements.

While Morrell and her fellow apple growers wouldn’t want anything but the safest decision on this issue, she pointed out that “at this time, there is no data that shows whether evaporative cooling with water that is high in bacteria leads to bacterial presence on the apples at harvest.”

The reason why questions arise over this issue, Morrell said, is that there’s so much heat and UV radiation in the orchard when the fruit on the trees is sprayed for evaporative cooling that it’s unlikely the bacteria would survive on the fruit.

Research is needed to see if evaporative cooling poses any risk to the ultimate consumer of the apple, she added. If it doesn’t, then FDA should accept the findings of that research and adjust its standards.

Schlect said the industry definitely needs answers “based on science” on such questions.

“Growers are not very happy about more regulations and scrutiny of their practices,” he said. “There’s a lot of uncertainty right now. They get irrigation water from various sources. They don’t want to see their operations shut down during harvest, and they don’t want to face any liability.”

Yet he continues to remain optimistic.

“If the science shows there’s not a problem, the agency will be flexible,” he said. “Once the rules are out and the science develops, we’ll be going back to FDA for changes that can be made. That’s important because the rules are there for public health.”

Unfortunately, Schlect added, there are a lot of unknowns simply because not much research has been done on apples because they represent a relatively low-risk category.

“Research goes to ‘serious problems,’” he said. “Eating fresh fruits is low on the list of concerns. People have been eating apples with no problems almost since the dawn of time.”

Food-safety expert Trevor Suslow of the University of California-Davis told Food Safety News that more often than not, more data are needed specific to a region and to the agricultural practices of a commodity in that region.

“The bigger need is for short-term projects to help build data,” he said. “The challenge for growers and packers is to know your water.”

He also pointed out that there are a number of things to consider other than water when looking for evidence of pathogens on fruit. For example, the Listeria outbreak involving apples from Bidart Bros. made it clear that a “whole-systems approach” — not just looking at one specific piece of a system — is necessary.

Criminal charges

On the legal front, Schlect warned that criminal actions in food-safety cases “have been on the uptick” as federal prosecutors seek jail time in especially egregious cases.

An example of that is the conviction and recent sentencing of two executives and a quality control manager for Peanut Corporation of America following a deadly Salmonellaoutbreak. Among the many charges against them were falsifying food-safety tests and knowingly shipping peanut products contaminated with Salmonella to customers.

“This sentence is going to send a stiff, cold wind through boardrooms across the U.S,” food-safety attorney Bill Marler told a reporter just after the PCA sentences were announced. (Marler is also the publisher of Food Safety News.)

He also pointed out that people in the food business are now very much aware of the no-longer-quiet criminal provisions in the 1938 Federal Food, Drug and Cosmetic Act — both felony and misdemeanor sections.

Schlect also warned that recent advances in testing technology for human pathogens will make criminal or civil actions even more likely. For example, the Centers for Disease Control and Prevention’s (CDC) continued expansion of its use of genome sequencing, which Schlect said provides a much more accurate and quicker way of linking a specific food product with foodborne outbreaks.

Worker training

Morrell said the apple industry expects the worker-training requirements to be “manageable.”

“We are already training orchard workers on food safety at the time of hire, with constant reminders throughout the season,” she said, adding that workers are also being trained on ladder safety, heat stress and many other safety topics. “So any new training requirements in the FSMA should be easy to add to our programs.”

What’s next?

The Northwest Horticultural Council’s Food Safety Committee and staff will be reading and trying to interpret the FSMA regulations as they’re published. Pointing out that the rules can run from 800 to 900 pages, Schlect said that staff members from various associations, as well as lawyers, will try to decipher them so they can be explained to growers and packing house owners.

But, he added, at the heart of it all is this reality: “Food safety is with us; it will not go away.”

Timeline on FSMA rules

The first two of the seven FSMA rules — Preventive Controls for Human Food and Preventive Controls for Animal Feed — were finalized in mid-September and are now up on the Federal Register. Compliance for some companies will begin in September 2016.

Broadly, the rules governing food for humans require registered food facilities to maintain a food-safety plan, perform a hazard analysis, and institute preventive controls for dealing with those hazards. Facilities also have to verify and document that their controls are working.

FDA is holding a public meeting about implementing these rules on Oct. 20 in Chicago. This meeting can also be viewed via live Webcast.

The Produce Safety Rule is expected to be finalized this month. This rule establishes science-based, minimum standards for the safe growing, harvesting, packing, and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.

Morrell advises growers and packers to read the final produce rule when it’s published in the Federal Register so they can learn about any requirements that are different from what they’re currently doing.

“Our industry will come together to help all growers comply with the federal laws,” she said.

Other FSMA rules yet to be finalized by FDA:

• Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Proposed Supplemental Rule
• Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications Proposed Rule
• Sanitary Transportation of Human and Animal Food Proposed Rule
• Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule