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FSMA 101: 'You Are What Your Records Say You Are'

Over the past few years, the entire food industry has been invested in understanding the mandates of the FSMA and how it might affect their companies. With the proposed rules in progress and deadlines quickly approaching, there is no better time than right now to start thinking about how your business will work to implement the rules.

“Many are confused as hell as to what to do with their food processing facility when it comes to complying with FSMA,” Craig Wilson, VP, GMM Quality Assurance & Food Safety, Costco Wholesale, said during an in-depth educational session at the Food Safety Summit last week.

More than 1,500 industry professionals convened in Baltimore on April 28-April 30 to take part in the three-day event that included workshops, educational sessions and a tradeshow floor.

One of the main highlights of this year’s Summit included the focus on the Food Safety Modernization Act (FSMA), which targets ways to prevent food safety hazards in the food supply.

Over the past few years, the entire food industry has been invested in understanding the mandates of the FSMA and how it might affect their companies. With the proposed rules in progress and deadlines quickly approaching, there is no better time than right now to start thinking about how the regulatory agencies, the industry, and your business specifically will work to implement the rules.

You are what you say you are

Joseph Leavitt, former FDA CFSAN Director, said there will be a shift from “Are you doing this right?” to “Do you have the right systems in place and is your system working?”

“You are what your records say you are,” Leavitt said. “That should be your FSMA mantra. It’s going to be a whole new world with FSMA inspections.”

As a lawyer, Leavitt pointed out that the FDA will now have access to all food safety records when they visit a facility so it is important that companies have a plan in place for what records it creates, how they demonstrate that the activity was controlled, how they are formatted, who approves them, how deviations are addressed and when and how they will be maintained.

Inspectors aren’t just going to ask to see what you are doing today, but they are also going to want to know what you were doing last week, last month and even last year. That’s going to be a huge change in the industry, Leavitt stressed.

Nobody wants to end up with recalled products, so staying in compliance is key. To help break it down even further for easier understanding, it’s important to note that the FDA has identified three kinds of controls: sanitation, allergen and process.

Learn More: Preventing Contamination: A guide to material selection for food and beverage equipment

Inspectors are going to be checking to make sure these controls are in place and what kind of system you have for each. Each facility will be expected to have a plan and to be following it.

Leavitt said validation is not having the mindset of “we’ve always done it this way and never had a problem.” Rather, it is monitoring, taking corrective measures and documenting everything.

“Don’t worry if something goes wrong,” Leavitt said. “Just be up front, address it and document it.”

Leavitt stressed that the FDA is really going to be looking whether or not your company shows that it cares about food safety and is trying to put preventative measures in place.

FSMA in phases

In Phase 1, the FDA set standards (regulations, guidance, policies), which will stay in place until the rulemaking is finalized.

The FDA, including Deputy Director for Regulatory Affairs Roberta Wagner, is now working to develop enforcement strategies in Phase 2.

Phase 2, the stage the mandates are currently in, consists of planning and implementing best practices to gain and maintain industry compliance with FSMA rules.

Some of the guiding principles we are seeing in Phase 2 include:

  • FDA will speak with one voice
  • Investigators and subject matter experts (SMEs) will work together to drive correction of problems
  • Invest in regulator training
  • Invest in federal/state integration/leveraging with public and private sectors
  • Education before regulation
  • Enhance risk-based work planning/inspection models
  • Range of inspection, sampling, testing, activities
  • Robust data integration, analysis and information
  • Sharing public health metrics

Wagner said giving the industry a chance to understand all the rules first is important.

“Education before regulation,” Wagner said. “That is the culture change.”

But while the need to establish good methods of training that go above and beyond is important in gaining competent oversight of the industry, Executive Director of AFDO Joe Corby said compliance will be interesting.

“It sounds good on paper, but it’ll be difficult to put together.” Corby added.

The goal is still the same

States are already performing the majority of inspections at food facilities, but by using an Integrated Food Safety System (IFSS), the food industry can collectively develop on what needs to be done on inspections, and then work to implement it.

“Compliance will be interesting,” Corby said. “FSMA is the most comprehensive reform of our food system in our history.”

Read More: Integration in Food Safety: The Time is Now

Some of the challenges the FDA is dealing with in the current phase of FSMA is finding the correct resources to do the work, creating the infrastructure to implement the changes, and driving the culture change.

After Phase 2 of FSMA is complete, the last Phase will consist of continuing to implement the rules, but also begin to evaluate, monitor and refresh the regulations. This will be the time to look if the industry is achieving its goals, and if not then shift gears, Wagner said.

But as Wilson points out, one important thing to remember is that the goal is and always has been the same: to create safe food for consumers. And the easiest way to do that is prevention, as it is much simpler than dealing with issues.

“I think people are concerned that [FSMA] is going to be a hammer and it’s not,” Wilson said.

Wilson stressed that your higher ups are going to give you the resources you need to help you understand.

To be efficient, everything has to be effective. Therefore, staying consistent in all that you do as a company is an important first step.

“The global message in food safety is if you’re not consistent, you’re going to have problems,” Wilson said.

To end the “Implementing FSMA: Opportunities for Collaboration” session, Wilson said learning to evolve is key. FSMA is going to be constantly changing, therefore approaching it in a simple way is probably your best bet.

“Are you going to change the way you bake muffins because of FSMA? Probably not,” Wilson said. “FSMA is not something you should be afraid of, because it is going to be a positive thing.”