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FDA’s Preventive Controls: Moving to HACCP and Beyond

The U.S. Department of Agriculture has required meat and poultry facilities to operate under risk-prevention Hazard Analysis and Critical Control Points systems since the late 1990s. But other than the seafood and juice industries, no food makers regulated by the U.S. Food and Drug Administration have been asked to do the same.

With the passage of the 2011 Food Safety Modernization Act, however, FDA will soon be requiring many of the facilities it oversees to establish “preventive control” systems closely modeled after HACCP, the systematic approach to food safety that attempts to minimize the risk of pathogens, allergens or other contaminants from ending up in any final food product. FDA has a public comment period open on its proposed preventive control rules ending September 16, 2013.

So, how do the FDA’s preventive control rules compare to USDA’s HACCP rules?

According to Jenny Scott, Senior Advisor in FDA’s Office of Food Safety, they measure up “quite well.”

For one thing, Congress has exempted the requirements for hazard analysis and risk-based preventive controls for seafood and juice facilities that already use HACCP.

But beyond those two industries, many FDA-regulated manufacturers already have HACCP plans in place for a number of reasons, including customers such as grocery retailers or restaurant chains requiring them. Those facilities may need to make some changes, but for the most part, they “will be well on their way toward complying with preventive control rules,” Scott said.

Congress has also asked FDA to ensure the preventive control regulations would be consistent with existing hazard analysis and preventive control programs, all of which are HACCP. The proposed rules start with HACCP language, too.

The Food Safety News HACCP series is sponsored in part by the National Registry of Food Safety Professionals.

FDA proposes to require every registered facility to include a preventive control program that includes each of the following:

  • A hazard analysis that identifies foreseeable hazards for each type of food manufactured, processed, packed or held at the facility.
  • Preventive controls to significantly minimize or prevent hazards that are reasonably likely to occur.
  • Monitoring procedures to provide assurance that preventive controls are consistently performed.
  • Corrective actions that would be used if preventive controls are not properly implemented.
  • Verification activities to ensure that preventive controls are consistently implemented and are effective.
  • Record-keeping systems to keep a written food safety plan regarding all of the above elements.

Given all of that, the biggest difference between the preventive controls and HACCP is that the preventive controls rules go a little beyond HACCP requirements, according to Scott.

“The preventive controls may also be HACCP controls, or there may be some other preventive controls people use that aren’t part of their HACCP plan, per se,” Scott said, citing examples such as environmental monitoring verification or sanitation procedures.

One important note is that the new preventive control rules only apply to facilities that are registered with the FDA under section 415 of the Food, Drug and Cosmetic Act. That means farms themselves are exempt from the rules, but any processing facilities must comply.Scott said that while she recognizes the criticism that implementing preventive plans may be costly for small firms, she said that firms already ensuring they make safe food should have a lot of the compliance legwork already completed. Complying with record-keeping requirements and validating preventive controls will likely contribute the greatest burden to smaller firms, she added.

FDA plans to further assist small firms with preventive control education, much like how USDA has supplied HACCP education to small meat and poultry firms for years.

In cooperation with the Illinois Institute of Technology, FDA has supplied funding to develop a Food Safety Preventive Controls Alliance, which is currently developing a standardized curriculum for training the industry in the preventive control rules.

FDA might consider following USDA when looking for other avenues for education. USDA supplies guidance documents online, as well as a call-in help desk for small firms and numerous other programs.

USDA tries to draw a fine line between telling establishments exactly how to run their HACCP programs and giving them guidance to make it easier to follow the rules, said Dr. Daniel Engeljohn, assistant administrator for the Office of Field Operations at USDA’s Food Safety and Inspection Service.

“If you a firm doesn’t have the resources to develop your own safe cooking procedure, we give them the procedure that the science demonstrates would be effective, and give them examples of validated procedures they could follow,” Engeljohn said. “That makes complying with our HACCP regulations much, much simpler.”

Engeljohn said that of the 2,000 calls that the USDA’s small help desk fields each year, roughly four to seven percent (80 to 140 calls) are for questions specifically related to HACCP. And more than 90 percent of the firms USDA regulates fall into the categories of small or very small, he added — the firms most likely to require guidance on rules surrounding HACCP.

Smaller operations often handle a great variety of products, as well, whereas larger operations tend to specialize in one or only a few complex products. Smaller firms may face a greater burden due to the record-keeping requirements involved with each product they make, so USDA wants to make the process as simple as possible for them, he added.

“I’d say in general we get positive feedback on the educational outreach we provide,” Engeljohn said. “There’s objection to the process itself, but not necessarily to the resources we make available to assist with that process.”

After all, Engeljohn and Scott agreed, most food manufacturers want to make sure they’re doing everything they can to avoid causing a foodborne illness outbreak, and preventive control measures help ensure that. It can happen to anyone who isn’t careful, Scott said.

“People need to think carefully about the hazards that might be associated with their facility and not be in the mindset of ‘No one has every gotten sick from the product that I make,’” Scott said. “We keep finding that every time you turn around the bugs surprise us and show up in a new food type.”

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