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Q & A: What FSMA Means For The Food Industry

FDA has a legislative mandate to require comprehensive preventive controls across the food industry and has mandatory recall authority.

Dr. David William Kennedy Acheson, Leavitt Partners
Jonathan Cowan, Senior Account Executive, Plex Systems, Inc.

Tom Nessen, Senior Solution Engineer, Plex Systems, Inc.

Plex Systems will host a webinar titled Food Safety Modernization Act (FSMA): What It Means to the Food and Beverage Industry. Food Manufacturing spoke with Plex Systems and Leavitt Partners about the new FSMA and what it means for food manufacturers.

Q: What are the most important aspects of the FSMA, and how will the act impact food companies?

A: The most important aspects of FSMA can be broken down into five main areas: preventive controls, inspection and compliance, imported food safety, response and enhanced partnerships.  What this means for food companies is that FDA has a legislative mandate to require comprehensive preventive controls across the food industry. These controls will be monitored and enforced by the agency through a mandatory inspection regime that specifies how often FDA should inspect food producers. FDA also has new tools to ensure that imported foods meet U.S. food safety requirements. FSMA creates additional accountability for importers by requiring them to verify that their foreign suppliers have adequate preventive controls in place to ensure safety and FDA will be able to accredit qualified third party auditors (government and private) to certify that foreign food facilities are complying with U.S. food safety standards.

In the response area, FDA now has mandatory recall authority for all food products. The agency will also require more recordkeeping information for high risk foods in order to more rapidly and effectively identify recipients of such food in the instance of a foodborne illness outbreak. Finally, the legislation recognizes the importance of strengthening existing collaboration among all public health and regulatory agencies—U.S. federal, state, local, territorial, tribal and foreign—to achieve inspection and public health goals. 

Q: How will the FSMA impact the way food manufacturers conduct audits and keep records?

A: Under the new law, FDA will have greater authority to access facility records and require that more records be kept. Significant here is the food safety plan for registered facilities, as well as produce safety plans and transportation safety plans. The food safety plan and all related documents must be made available to FDA upon request. As part of a facility food safety plan, the facility will be required to conduct a hazard analysis, implement preventive controls and develop a written food safety plan to document the monitoring, correction and verification of preventive controls. Facilities are likely to also be required to document and keep records on sanitation procedures, a recall plan, a food allergen control program, supplier verification activities and an environmental sampling program. Records tied to a facility’s food safety plan must be kept for at least two years.

Food manufacturers will need to conduct internal audits as a means to verify that their preventive controls are effective. Food manufacturers who are importers will also need to conduct audits to verify their foreign suppliers have adequate preventive controls in place to ensure safety and compliance with U.S. standards. Audit criteria, frequency and metrics will all be driven by FSMA regulations. 

The pressure to increase the level of record keeping and the ability to produce those records quickly during an audit will impact the way records are stored. Traditionally, food manufacturers have kept paper records related to food safety and compliance that were difficult to access when needed. With the FSMA legislation many food manufacturers are re-examining this approach.  An Enterprise Food Safety Management system (FSMS) brings together all critical food safety activities: inventory traceability, HACCP, recall management and digital document control. Tied together FSMS provides quick access to all vital records needed for audit purposes. The maturing of cloud-based delivery methods now makes a Food Safety Management System affordable for food manufacturers of all sizes

Q: How will the FSMA change the way food manufacturers manage product recalls?

A: A company’s survival may depend on how well and how quickly it responds to the first notification indicating that a product recall or other regulatory action might be necessary. FSMA requires that each facility have a written product recall plan as part of the facility’s food safety plan. A facility’s compliance history, including with regard to food recalls, will be in part how FDA identifies high-risk facilities. Under FSMA, FDA now has mandatory recall authority. It is unlikely, however, they will use the new authority extensively and they will likely reach out to a facility to conduct a voluntary recall first. Additionally, one of the few fees included in the new legislation is tied to compensating FDA for agency resources expended in the case where the agency has had to invoke a mandatory product recall. Finally, FSMA will require grocery stores to post in-store notifications about food they carry that has be subject to a Reportable Food Registry submission and the agency has created a more user-friendly database of recalls. Food manufacturers will need to be able to quickly get their arms around the scope of any problem to limit the size of the potential recall and the extent of brand damage.

Tightly controlling and limiting the impact of product recalls will become increasingly more important to food processors as the FSMA is implemented. If proper record keeping discipline is supplemented by the latest available technology then it is possible to respond quickly to product recalls when they occur. A company’s ability to demonstrate its ability to contain and manage product recalls can set it apart from competitors and earn them a competitive advantage in the marketplace. 

Q: What should food companies do to prepare for the new regulations?

A: A good start is to understand more fully the requirements of FSMA and the other key shifting dynamics of the U.S.-specific and global food-safety landscape. Once you have a better understanding of where things are headed, work to get out in front. Understand and address your own risks and vulnerabilities through an assessment of your own internal systems and gain greater upstream visibility into your supply chain. 

Food processors need to take a new look at the available technology in the marketplace that can automate manual and paper based processes. The use of systems that bring together manufacturing, quality and food safety information and make it easy to access at a low cost will set apart best in class food manufacturers from the rest of the field.