“It’s a lot to take in — like drinking from a fire hose.”
That’s how Donna Garren, regulatory affairs and technical specialist with the American Frozen Food Institute, describes the challenge that food facilities are grappling with as they move toward the deadline for compliance with the Food and Drug Administration’s preventive controls rule for human food.
Simply put, the rule, which is is part of the 2011 Food Safety Modernization Act, requires registered food facilities that manufacture, process, pack or hold food for human consumption to take these steps:
- Maintain a food-safety plan;
- Analyze where hazards pertaining to food safety exist in their operations; and
- Put preventive controls into place for dealing with those hazards.
Facilities also have to verify and document that their preventive controls are working. Also, according to the rule, the plans must be re-analyzed at least once every three years.
Compliance dates vary according to the size of the company. But for the largest ones, the deadline is Sept. 16. Small and mid-sized companies have until September 2017, and very small companies have until September 2018.
There’s no waffling on this. The FDA clearly spells out when companies must come into compliance.
“It’s the law,” Jim Gorny, vice president of food Safety and technology for the Produce Marketing Association, said during a recent presentation at the Center for Produce Safety’s annual research symposium in Seattle. “It’s on the books.”
The good news — at least in the case of the larger companies — is that many, if not most, of them have already been making changes and are therefore “definitely getting there,” Garren said.
“The majority are in a good place,” she said, explaining that many of them already have food-safety standards in place, which include those of the Global Food Safety Initiative, as well as food safety requirements for the British, French, Italian and German markets.
“It’s a global effort,” she said. “The food and beverage sectors have moved toward certification, which has helped the industry improve.”
The FDA oversees dietary supplements, bottled water, food additives, infant formulas, pet foods, livestock feeds and most other human foods not under the jurisdiction of the USDA, which regulates meat, poultry, dairy, eggs and catfish.
Foreign producers selling to U.S. buyers must also gain certification that they’re complying with the FDA’s preventive controls rule.
“Companies are really committed to this,” Garren said, although she conceded that she’s sure there are some companies that need to know more about it to meet the compliance deadlines.
She urges the small, medium-sized and very small companies to take advantage of the time they still have left.
“The sooner the better,” said Bob Brackett of the Food Safety Preventive Controls Alliance. “You shouldn’t wait. You should be getting ready, not just thinking about it.”
As for the very small companies, Garren said that county extension agents at land grant universities are going through training to help.
“They can be a good resource,” she said, adding that they can help provide access to pilot plans geared to the needs of the very small companies.
The reason behind the regs
While it’s easy to get mired down in all of the requirements of the preventive controls rule, the underlying reason for the rule — as well as for the other rules under the Food Safety Modernization Act — comes into sharp focus when considering why they were adopted in the first place:
- “The whole purpose is public health,” said Brackett “If everyone’s onboard, we’ll have safer food.”
- “FDA doesn’t make food safe,” said Gorny. “It’s the responsibility of the industry to make food safe. Ultimately, we’ll have an even safer food supply.”
- “It’s about adopting a culture of food safety to produce safe food,” said Garren.
In explaining the need for the rule, FDA points to high-profile outbreaks of foodborne illnesses during the past decade. Statistics show that foodborne illnesses strike an estimated one in six Americans each year. According to the agency, about 128,000 people in the United States are hospitalized, and an estimated 3,000 die each year from foodborne illnesses.
“Requiring preventive measures at facilities that produce human food is an important step in reducing foodborne illness for people,” FDA reports.
In other words, this isn’t just about food manufacturing facilities; it’s about every point along the supply chain, from production plants to restaurant kitchens, preventing foodborne pathogens such as E. coli, Salmonella, Listeria, and Campylobacter from sickening and sometimes killing people.
The FDA regulates about 80 percent of the U.S. food supply — approximately $602 billion in domestic food and $64 billion in imported food each year.
The preventive controls rule will cover an estimated 97,600 domestic and 109,200 foreign facilities. According to FDA, in 2011, about 50 percent of the fresh fruit consumed in the U.S. was imported.
Although some activities carried out on a farm may classify the farm as a facility, the rule doesn’t pertain to operations that meet the FDA’s definition of a farm.
The Produce Rule, another part of the Food Safety Modernization Act, goes into effect in November 2017. It includes standards for growing, harvesting, packing and holding of produce for human consumption. For the most part, it covers produce that will be eaten raw.
What if facilities miss the deadline?
To begin with, although the compliance date for the larger facilities is set for Sept. 16, Gorny said that the FDA still needs to train inspectors, which he describes as “a heaping huge job.” He doesn’t think they’ll start doing inspections until some time in January.
When they do begin, the inspectors will show up without notice. Here are some of the things Gorny said could happen:
- If a facility is not in compliance, the FDA can issue a warning letter of violations and list the changes that need to be made. Once the changes are made, the FDA will reinspect.
- The agency can ask the facility to recall a product, or products, voluntarily.
- The agency can mandate a recall.
- The agency can withdraw a facility’s registration.
- The agency can go to court and seek a permanent injunction.
“The rule describes what sanitation standards are required,” Gorny said. “Before the Food Safety Modernization Act, they were left open to interpretation. Now they’re very structured. The rule lines it out to a greater degree.”
Bottomline, it’s all about preventing foodborne illnesses instead of reacting to them, as was the case before the Food Safety Modernization Act was signed into law.
All facilities covered under the preventive controls rule must have a written food-safety plan, which includes an analysis of hazards and risk-based preventive controls.
The first step is identifying where hazards pertaining to food safety exist in the facility. From there, controls to prevent the hazards must be put into place, including having an established recall procedure. The written plan must show how the preventive controls are monitored and managed to make sure they’re effective and to correct problems that may arise.
Then there’s verification and validation. Simply put, validation means your preventive controls are working, and verification means that the controls are being implemented effectively.
All of this requires documentation. There’s a lot of record keeping to be done.
“You need to get your records in line and have them organized and ready for the FDA inspectors,” said Brackett.
What about the human element?
Some of the agency’s previously “non-binding” provisions, such as education and training, are now binding. For example, management must ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. That means, they must have the necessary education, training and/or experience.
They must also receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene. Managers and owners will be held accountable for employee training.
Under the preventive controls rule, a company must hire someone, or train an existing employee, to make sure the company is implementing the requirements. The larger companies usually have someone onboard to do this, but many small and mid-sized companies don’t.
In addition, a company will have to prove to the FDA that the person tasked with this has been properly trained to do the job.
“The biggest frustration with this is that it takes a trained person monitoring everything and doing the record keeping,” said Skagit County, WA, berry processor Mike Youngquist. He recently sold his processing equipment to a nearby farm. “You almost need a trained college person, and that’s all they do. For a seasonal packer, that can be difficult.”
And while Youngquist said he believes food safety is of paramount importance, he said he can’t help but think there’s some “overkill” in the rules.
Brackett said that while many of the larger companies have the necessary resources when it comes to having a trained food safety worker on site, the small and mid-sized companies generally don’t.
“For them, the Food Safety Preventive Controls Alliance is their resource,” he said.
FSPCA specifically designed to help with FSMA
The Food Safety Preventive Controls Alliance (FSPCA) was created in 2011 by the FDA in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health. The FSPCA was established to help industry —particularly small and medium-sized companies — comply with the new preventive controls rule as mandated by the Food Safety Modernization Act (FSMA).
Members of the alliance are from the FDA, state regulatory agencies, the food industry, and academia.
The alliance offers a two-day training seminar that will earn those who successfully complete it a certificate as a “preventive controls qualified individual.”
The alliance also has a technical assistance network site, to provide answers to technical questions. People can also ask others in the network for tips about what they’re doing pertaining to specific questions, for example how they store their petri dishes. The discussions can be private or public.
Brackett said this feature is “like a social network.”
Food safety worksheets are also available from the alliance.
“All of this is designed to help small and mid-sized companies, especially, comply with the rule,” Brackett said.
To date, the alliance has issued 11,000 certificates of qualification to individuals from both large and small companies, 10 percent of which are international. It has also issued 800 certificates for lead instructors.
The missing pieces
Ironically, FDA has not yet released the guidance documents that companies can use to help them evaluate whether or not they’re in compliance with the preventive controls rule.
“These guidance documents, especially the one on ‘hazards,’ will be critical,” said Garren. “We wanted them yesterday. We’re hoping to see some of them in the early fall, but we have no confirmation of that yet.”
“The uncertainty over this is breeding fear,” said Gorny. “People are wondering what more they need to do and how much it will cost.”
In addition to the guidance documents on hazard analysis and preventive controls, there are documents on environmental monitoring, food allergen controls, validation of process controls, and a small-entity compliance guide that explains the actions a small or very small business must take to comply with the rule.
Megan Bensette, FDA spokesperson, said the development of guidance related to the human food preventive controls requirements takes time because the requirements apply broadly across the food industry and because the guidance requires input from many subject matter experts.
The agency will issue notices in the Federal Register and make announcements through its “Constituent Updates” of availability of draft guidance documents when they are posted for comment.
As for nailing down exactly when the documents will be available, Bensette could only say: “We are working expeditiously on the guidance, but unfortunately I’m unable to give a timeframe.”
Food safety attorney Bill Marler said that under the federal Food, Drug and Cosmetic Act, a misdemeanor conviction — unlike a felony conviction —does not require proof of fraudulent intent, or even of knowing or willful conduct.
Rather, people can be convicted if they held a position of responsibility or authority in a firm that would have allowed them to prevent a violation.
Convictions under the misdemeanor provisions are punishable by not more than one year in prison and/or fines up to $250,000 per count.
As for the “heavier stuff” — punitive damages and criminal liability — Marler said it comes down to this question: Did you act with conscious disregard of a known safety risk? Prison time and hefty fines, not to mention steep payments to victims and the closing of a business, can come into play when the answer to that question is yes.
Editor’s note: Food safety attorney Bill Marler is publisher of Food Safety News and a founding member of the Marler Clark law firm in Seattle.
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