Sep 25, 2017

Produce industry starts to prepare for FSMA inspections

The Food Safety Modernization Act (FSMA) is in place, and inspectors are coming.

The compliance date for larger manufactured food facilities subject to FSMA’s human food preventive controls rule kicked in on Sept. 19, 2016. The compliance date for those facilities considered “small businesses” is Sept. 18, 2017, and for “very small businesses” it is Sept. 17, 2018.

Jim Gorny, vice president, food safety and technology for the Produce Marketing Association, said the organization released a “Food Regulatory Inspection Manual” and has held webinars on the implementation.

“An FDA inspection need not be a stressful experience,” he said. “The key to a successful inspection is preparation, and the time to prepare is right now, before FDA knocks.”

Sylvia Ballinger, U.S. Food and Drug Administration communications specialist, notes the FDA encourages companies to take advantage of the information presented at numerous public meetings on all the FSMA rules and countless webinars that the agency has hosted.

“In addition, we are providing numerous guidance documents to help the industry understand our thinking,” she said. “As one example, we have posted five chapters of guidance related to hazard analysis and preventive controls for human food. We have also posted a small entity compliance guide and guidance on Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.”

FDA also implemented a “Technical Assistance Network” (TAN) as a central source of information for questions related to the FSMA rules, programs and implementation strategies. If food businesses have questions specific to their operations they can submit their questions online for subject matter experts to provide an answer via email.

Bob Ehart, senior policy and science advisor for the National Association of State Departments of Agriculture, said the Food Safety Preventive Controls Alliance (FSPCA) has developed training materials for the industry.

“Prior to the compliance dates being effective, all facilities should have appropriate staff trained and knowledgeable about the new requirements under FSMA,” he said. “Most larger firms will have had experience with GMP (good management practices) inspections and may have knowledge of risk-based preventive control- type systems such as hazard analysis and critical control points (HACCP); some will have less — perhaps no — experience with a preventive controls inspection.”

Jennifer McEntire, vice president, food safety and technology for the United Fresh Produce Association, said one of the most important things food companies need to understand is how the concept of preventive controls relates to HACCP critical control points and existing GMPs/ prerequisite programs.

“The FSPCA Preventive Controls for Human Foods course is one way to begin understanding the difference,” she said.

“Also, companies really need to think about how they document what they do. For fresh-cut operations, they should review documentation around controlling wash water, and think about how they can demonstrate that wash water doesn’t contribute to pathogen cross-contamination.”

The primary goal is to create a climate of food safety, a culture of compliance with procedures, processes and practices that will minimize the risk of serious illness or death.

“Food processors should look at areas in which they could be vulnerable and take action proactively,” Ballinger said. “Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.”

In the beginning

While the measures are still early in the implementation process, FDA has so far had a few preventive controls inspections. In 2017, the FDA will be conducting 300 preventive controls inspections (240 domestic and 60 foreign) for human food facilities that were required to comply as of September 2016.

“In FY18, we will begin inspecting small businesses for compliance with preventive controls,” Ballinger said. “To facilitate compliance with the new requirements, we are educating while we inspect. However, the FDA is a public health agency with a mandate to protect public health; when necessary, the agency will act swiftly.”

Ehart notes that the inspections, particularly the preventive controls inspections, will take time. GMP inspections in the past took about a day or day and a half. With the addition of the preventive controls inspections, it is likely inspections will last four to five days.

The coalition of state departments of agriculture is taking a lead role on implementation of the produce safety rule. FDA has entered into cooperative agreements with more than 40 states, and they will perform outreach, provide technical assistance and conduct inspections in support of the produce safety rule.

Getting ready

FDA has been training investigators to perform modernized GMP inspections and preventive controls inspections for over a year. Right now, FDA reports it has trained a special cadre of 30 investigators, and they are conducting inspections based on risk. These individuals are conducting the initial inspections, and are training others in the process.

“We have a smaller number of investigators who have been through the training to conduct preventive controls inspections,” Ballinger said. “We have enough fully trained staff to perform the number of inspections we intend to conduct in FY17, and are training staff to perform the number we intend to do in FY18.”

McEntire said Congress requires that FDA inspect “high risk” facilities every three years, and other facilities every five years, after an initial ramping-up period. FDA is devoting substantial resources to train their investigators and build the capacity and competency of their workforce.

FDA has often said it will “educate while they regulate” and McEntire notes they seem to be practicing what they preach.

“This is not to say that FDA will be lenient in their inspections, especially if public health is at risk,” she said. “Companies should also know that FDA reorganized their inspectors, so that moving forward, food facilities will be inspected by investigators with food- specific expertise (as opposed to inspectors who are more familiar with medical devices, cosmetics, etc.).”

When the inspector comes

Gorny said it’s important for companies to have a team of people ready who know their roles when the state inspector shows up.

“You’re probably going to want to have written policies,” he said. “People should also drill or practice for inspections, just as you would for a recall, so you know what you’re going to do when that inspector shows up.”

The rules are new and guidance is not yet finalized (or even available as draft, for many issues), so everyone recognizes that there will be issues that need to be sorted out. Associations can help identify thematic issues during the early days of compliance and help facilitate conversations between regulators and the regulated industry.

“Those food companies that are processing fruits and vegetable have a new and continuing obligation to know and understand the produce safety rule and the new requirements placed on the produce industry as well as the rules directly affecting them,” Ehart said. “FDA should also develop other means by which it is participating in the advancement of safe food as well. We have an opportunity to excel. We should do so, collectively.”

— Keith Loria, contributing writer