From reactive to proactive — that’s the goal for two new rules issued by the FDA that are meant to level the playing field in terms of food safety in companies’ day-to-day operations.

The first two of seven finalized rules under the Food Safety Modernization Act were released earlier this month, and the preventive controls rules are of particular importance to food companies of all sizes. The rules will change not only how companies document and report their food safety efforts to the government but could also spur companies to overhaul their current food safety protocols to meet the new serious but flexible standards set by FSMA.

President Obama first signed the FSMA rules into law in 2011, not long after the Peanut Corporation of America salmonella contamination, but long delays prevented the release of finalized details for several years. In 2012, advocacy groups sued the government over the delay. FDA just made the Aug. 30, 2015 deadline to submit the rules to the Federal Register, but the agency didn’t announce the first two finalized rules to the public until a little over a week later.

New requirements for food companies

FDA deputy commissioner Mike Taylor said on a conference call that the new FSMA rules draw from "industry best practices that have been shaped not only by thousands of written comments but by extensive outreach and real dialogue with farmers, consumers, the food industry, and academic experts. Through this process, we’ve developed rules that will be effective for food safety and workable across the great diversity of the food system."

The main requirements for the new FSMA rules are that companies identify and address all safety risks associated with production and create written plans to document the food safety measures that will prevent or alleviate those hazards.

Though these rules may come with significant changes for some companies, large and small, the FDA has attempted to maintain a sense of flexibility with the arrangements so that companies can keep in place programs that are already working for them, even if they differ from those at other companies. For the FDA, there is no one-size-fits-all requirement.

"We have tried to put in flexibility because companies told us that, 'Oh, we’re going to have to trash everything that we’ve done and start over.' That’s not in the best interest of food safety," said Jenny Scott, senior adviser to the director of FDA’s Office of Food Safety at the Center for Food Safety and Applied Nutrition. "We have good programs, and that’s never been our intent. We want you to take programs that are working and continue to use them. But if there is a requirement in this rule that applies to you but you don’t have it in place, then add it."

The FDA plans to offer education and assistance to companies to identify whether they are compliant and, if not, what steps they can take to achieve compliance. Much of this information is online on the FDA and FSMA websites, but inspectors will be able to provide information as well, including handing out materials when necessary. Taylor said the FDA mantra has been, "We want to educate before and while we regulate."

Not all in the food industry agree the rules are necessary or helpful, and they often cite significant added costs as unnecessary effects of the FSMA regulations.

In an opinion piece published on Food Safety News, Richard Williams, vice president of policy research at the Mercatus Center of George Mason University, said that the new rules add costs without benefit, such as additional safety or modernization. He feels that not all of the rules solve a significant problem facing the industry, as they should, nor can their efficacy be measured. He also said that the FDA's chosen method, "command-and-control regulation and inspection ... [is] old, it’s outdated, and it’s not likely to work." And all of this comes at a cost to the industry.

"People need to recognize that making safe food does involve cost," said Scott. "... They may need to put into place measures to verify the things that they’re doing or validate some of their process controls, and these do involve costs. But the costs of doing this really pale in comparison to the costs of not doing the right thing."

What food companies can do to reach compliance

Study operations and how foods are processed.

Scott recommends that food companies begin by figuring out exactly how their products are made and what steps are involved in processing, from mixing and cooking to packaging, storage, and shipping. Having a complete picture of the way their products are made is the foundation for companies to determine whether any changes will need to be made to safety protocols and how best to document them. Scott says a flow chart can be helpful in this scenario.

Identify what could go wrong during processing.

Once each step of food processing is identified, next is to identify where the food safety risks could be. This could include identifying times when bacteria or other contaminants could be introduced by either humans or machines. Companies might identify potential allergen contaminants, which cause many recalls in the U.S., or possible issues with temperature control. Companies may also determine whether they are monitoring certain parts of processing with the correct frequency.

Whenever something could go wrong during processing, companies need to document that and envision what type of safety protocols could be put in place to address those risks, if something appropriate is not already in place.

Evaluate current safety protocols to ensure they address all potential risks.

Per the new rules, companies must be thorough and practical about whether current safety protocols address any and all potential safety hazards that could occur during processing or delivery to stores.

"Through this, at times, they’re going to have to get more scientific information to demonstrate that what they’re doing will actually control the hazards," said Scott. "We call this validation, and it is very important that for some of these processes that people may have been applying for years, if they say, 'Well of course it works. We’ve been doing this for years, and I’ve never been made to do a thing.' So now the real question is, how do you know? And then for us, how do you know it’s working?"

"We will likely see the frequency of independent audits at food processing and manufacturing locations increase to ensure compliance and reduce risks," said Kevin Pollack, vice president of recalls at Stericycle ExpertSOLUTIONS. "In house, food companies may add to their quality control staff to increase the frequency of sampling and testing products. They may even increase the amount of meetings between management and internal quality control to review test results and potential gaps or issues."

Train employees to ensure they understand all food safety protocols relevant to their jobs.

As executives and facility managers develop these food safety measures, they must take the time to train employees to follow through with those plans, especially if they have changed or if employees were not always following the previously outlined protocols. 

"They may have to implement more training of people to make sure that everybody understands food hygiene and food safety as it applies to their job," said Scott.

Document all efforts to prove efficacy of food safety protocols to FDA inspectors.

The food safety measures must be documented as written plans, and as companies carry out those plans, they must also document if and how the safety measures are working. Inspectors will be looking for evidence that food safety protocols in place are effective.

These changes come about in part because of the differing safety standards of other countries that now provide processed foods, beverages, produce, meat, seafood, and ingredients to the U.S. on a larger scale than ever before.

"Both ends of the value chain from the factory have become a lot more global," said Harold Schmitz, chief science officer at Mars, Inc. who recently oversaw the opening of the Mars Global Food Safety Center. "So there are food safety risks in play because of this more fragmented global supply chain that we as an industry didn’t grow up thinking about. … We need to make sure that the science, technology, innovation, and interactions across the sectors change with it or else we’re going to be missing a big opportunity."

The FDA believes that the opportunity lies in preventive practices that keep the food supply and consumers safe before a problem arises.

"The food industry needs to recognize that this preventive approach does work, and it is important that manufacturing and processing, packaging, [and storing] food take that approach and ensure that there’s safe food," said Scott. "… People need to step up to the plate and look at what needs to be done to ensure that they to know that they’re making safe food and to demonstrate [that] to auditors, regulatory agencies, and their customers."