Are you ready for FSMA?

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.”

Is your team ready?

Participating in a mock inspection can be an effective method to determine whether your team is prepared for an unannounced inspection. AIB International’s latest field service, FDA Preparedness Inspection, simulates a FSMA-type investigation and determines if a facility’s regulatory policy is in line with requirements, if employees understand their company’s policy for handling regulatory inspections and if its food safety plan meets requirements.

Alicia Pulings, quality compliance manager at Schaumburg, Ill.-based Gonnella Baking Co., set up one of AIB’s FDA Preparedness Inspection knowing there were minor gaps in the facility’s FSMA compliance process but still confident in her group’s abilities. With the exception of two key decision-makers, the visit was unannounced to its staff, including the plant manager.

“Even though it was a test inspection, I could sense our team’s uneasiness, and it reminded them that we need to be audit-ready at all times,” Ms. Pulings said.

When an AIB inspector began collecting swabs at the Gonnella plant, it was a big reveal for the staff. Ms. Pulings believed this was an eye-opener for employees, especially those who did not attend a FSMA training.

“Knowing FDA could collect swabs is new and important,” Ms. Pulings said. “We needed minor revisions to a few of our existing programs. During the inspection, we learned that FDA has granted an extension to one of our new programs that are in the process of being implemented — without this simulated inspection, we would not have known.”

Making sure an operation’s team also understands how to interact with investigators is crucial, as any of them can be pulled aside at any moment to discuss procedures in detail or to pull records. This may entail taking extra time to train employees on methodologies and educating them on the reasoning behind it.

“If people are going to do their job well, they have to understand why they’re doing it,” Mr. Thorson said. “We’ve got to do better at explaining processes. Whether it’s the employee on the floor operating and cleaning the line or the engineer building the system, everyone has to understand why we have the expectations we do: ‘Why do I need to clean to this level? Why are you swabbing it with that swab?’”

What to expect

Being prepared for an inspection means more than having preventive controls in place. Such preparation includes mapping out a process for when investigators arrive and understanding the actions they will take while conducting the inspection. In his checklist, Mr. Stevens outlined how operators can effectively navigate the process from beginning to end and appropriately respond to any FDA criticisms once the site visit concludes.

Before the inspection begins, Mr. Stevens advised teams determine which members will interact with FDA investigators, revisit where critical documents are stored and organized, and review topics employees can discuss with the agency. To ensure all measures are in place, perform a mock audit that includes all staff performing their specified roles. Undergoing this practice will help employees feel confident when interacting with investigators.

When FDA representatives arrive, they will ask to conduct an entrance meeting to detail how they plan to conduct the inspection, how long they anticipate it will last and the specific tasks they intend to accomplish. These typically include a facility inspection, records review and “swab-a-thon.”

During the inspection, the agent will tour the production, packing, distribution and storage locations searching for physical deficiencies and sanitation violations and conditions that allow bacteria to grow. Throughout the process, the investigator should be accompanied by a designated guide to observe and immediately document and respond to any concerns.

At the time of the records review, the FDA will have wide access to most documents within the organization. However, the agency is not entitled to review or copy any recipes or data pertaining to finances, pricing, research, sales or personnel, other than to ensure that the company’s employees have received training appropriate to their position and responsibilities. If the FDA requests copies of any records the company deems confidential, be sure to mark those records accordingly.

Once investigators enter the plant floor, they will collect approximately 100 to 200 microbiological samples from incoming ingredients, outgoing finished products and various environments within the facility. Staff charged with accompanying the inspection should carefully document the areas where samples are being collected. If any samples are positive, this information will be critical to determine the most appropriate response.

If the FDA collects finished product or processing line samples to test for the presence of Listeria Monocytogenes, Salmonella or any other pathogens, that facility should hold back any products made from the same lot or batch until the results come back. If any are positive, and the product has been held, a recall will not be issued.

Once the inspection is complete, the investigator will conduct an exit interview and share the findings. If violations have been identified, the agency personnel will issue a Form 483, which details the specific issues. Although not required by law, a company is generally expected to provide a written response with the appropriate documentation within 15 business days. The FDA will not pursue further regulatory action if the response adequately addresses the agency’s concerns.

In some cases, the investigator may ask the company to consider a recall of certain products. Any recall decisions — and whether to announce it — should be made very carefully and only after consultation with legal counsel. Mr. Stevens noted that many companies have successfully convinced the FDA, based on the availability of supporting facts, forensic analysis and scientific data, that a recall is not needed or that the scope can be significantly limited.

A reflective approach

As inspections come and go, they create opportunities for the industry to unite and learn from one another’s triumphs and mistakes. Mr. Heflich noted that food safety should not be a competitive process. Fostering discussions amongst companies builds confidence within the field and may provide insights the FDA can use to modify guidelines and protocols.

Industry groups already have expressed interest in creating guidance documents on FSMA requirements with two goals in mind: providing a valuable resource for their members and developing industry standards that can become part of FDA guidance in the future. The agency laid out steps for industry associations interested in developing food guidance documents and stated it would provide technical advice and check for potential conflicts with federal regulations.

“FDA has listened to a lot of what we asked for,” Mr. Heflich said. “We asked to keep it simple, not prescriptive; tell us what we need to do but not how to do it. The industry needs the flexibility and the ownership.”

With that in mind, he urged bakers to get involved with industry associations and discuss issues with peers and competitors to ensure that the industry can guide and define regulations and protocols set forth by the FDA.