Are you ready for FSMA?

by Anna Wiber
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Companies are required to keep at least two years of records on file for FDA investigators to review.
 
 

Armed with clipboards, swabs and a keen eye, the Food and Drug Administration (FDA) has slowly begun assessing bakery operations across the country. Under the Food Safety Modernization Act (FSMA), baking facilities will undergo inspections verifying that preventive controls are in place. And while being prepared for an unannounced inspection is at the top of many companies’ agendas, what should they expect when the investigators walk through the door?

Shawn Stevens, FDA consultant and attorney at FoodIndustry Counsel, LLC, said there are five enforcement priorities for the agency. These include critical review of food safety plans and verification records, extensive microbiological sampling, recall requirements for samples that test positive for pathogens exceeding FDA thresholds, comparing pathogens found in the facility against human isolates stored in the Centers for Disease Control’s PulseNet database, and initiating broader investigations — including criminal — of food companies whose products are found to have caused human illness.

With this in mind, bakers must ensure their records are up-to-date, staff is properly trained and preventive controls are established, all before investigators arrive.

For the record

Under FSMA, a company’s food safety plan should have been established in September 2016, but many bakeries are still struggling to develop an effective document that encapsulates its approach to identifying food safety hazards. It’s even harder to establish one that can be updated easily. Many facilities are creating overcomplicated plans, leaving room for questions they may not be able to answer during an inspection.

Len Heflich, former co-chair of the American Bakers Association (ABA)’s Food Technical Regulatory Affairs Committee (FTRAC) and current president of The Center for Food Integrity, witnessed this pattern within the field.

“The industry doesn’t grasp the concept of a food safety plan because FDA doesn’t spell it out — and we don’t want them to,” Mr. Heflich said. “We want to take the lead on this and define it ourselves.”

So, Mr. Heflich developed a model for food safety plans, which he shared with ABA members. The two-page report outlines the policies and programs that a facility should have in place and contains brief information about them. The policy and program specifications are then detailed in a separate document specific to plant processes and products. This model allows baking companies to break down the plan and detail how they manage, control and minimize risk.

Plant operators must also remember to update plans accordingly. In the report, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” the FDA expressed the plan must be reanalyzed at least every three years. This includes when changes are made to systems or equipment, when new information is discovered about potential hazards associated with the food or facility, when there is an unanticipated food safety problem, or when a preventive control, combination of preventive controls — or the plan itself — is ineffective.

“It’s an evergreen document and process,” said Rasma Zvaners, vice-president of regulatory and technical services at the ABA. “If you change something in your operations, revisit your food safety plan and update it accordingly. The food safety plan should not live on the bookshelf collecting dust.”

One of the biggest changes resulting from FSMA is the role recordkeeping will play in day-to-day operations and during inspections. Documentation is required to confirm that actions such as monitoring, verification, validation and more have taken place in the facility.

“In the age of FSMA, your records become the face of your company,” said Elizabeth Fawell, counsel at Hogan Lovells. “It is how you show FDA you are doing a good job, not just when the investigator is in the facility but also day in and day out. That’s why we continually advise people, ‘If it isn’t documented, it didn’t happen. And if it is documented, it happened just that way.’”

To ease the recordkeeping process, it is in a food manufacturer’s best interest to standardize the plan while allowing for specific details. This includes creating a method of documentation with the same format among forms while still recording all the necessary information. An area should also be designated for documents to be stored for easy access. Finally, a system should be in place that verifies documentation is completed clearly, as to avoid any gaps.

Karl Thorson, food safety and sanitation manager, General Mills, Inc., Minneapolis, advised food processors to avoid creating overly complex procedures they will not follow through with.

“Trust but verify,” Mr. Thorson said. “Trust that your employees are doing it correctly but also have a program in place to check on them once in a while to make sure it was getting done right.”

Continue reading to see if you think your team will be ready when FSMA goes into effect.

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