Are you prepared to implement the new requirements of the Food Safety Modernization Act (FSMA) and do you have the appropriate staff to help you do so? The answer is that no one knows—not even the U.S. Food and Drug Administration (FDA). Two of the key pillars of FSMA are the proposed rules relating to the manufacture of human food and the manufacture of animal food. While both require current Good Manufacturing Practices (cGMPs), the new and somewhat foreboding process that is being required for both is referred to as a Hazard Analysis and risk-based preventative controls. And it’s still not clear who is qualified to perform that process.  

Under the proposed rules for both human food and animal food, each covered facility would be required to prepare and enforce a Hazard Analysis and risk-based preventative controls process—also called a “written food safety plan” (which sounds a little friendlier). The written food safety plan would be required to include the following:

• A Hazard Analysis that identifies and evaluates known or reasonably foreseeable risks for each type of food manufactured, processed, packed or held at the facility. This analysis looks for potential hazards beyond the critical points-type of analysis.

• Preventive controls must be identified and implemented in response to any risks identified in the Hazard Analysis to prevent or significantly minimize those risks.

• Monitoring procedures must occur and be overseen to provide assurance that the risk-based preventive controls are consistently performed and records must be maintained to document that monitoring has occurred and its results.

• The safety plan must identify corrective actions that would be taken if preventive controls are either not properly implemented or fail. Corrective actions must also include a written recall plan.

• Verification activities must occur to ensure that preventive controls are effective. If verification indicates that the preventive controls are not effective, or if new products or procedures are introduced, a new Hazard Analysis is necessary.

• Facilities would be required to keep written records of their food safety plan, including the underlying Hazard Analysis. They also would be required to keep records of preventive controls, monitoring, corrective actions, recall plans and verifications.

• “Qualified Individual(s)” must prepare and oversee the entire process.

Perhaps the most ambiguous term in any of the new FSMA proposed rules is the term “qualified individual.” Both the human food and animal food manufacturing rules mandate that a “qualified individual” (or individuals) must prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct any reanalysis of the food safety plan (or oversee these activities). The definition of a qualified individual is someone who has successfully completed training in the development and application of risk-based preventive controls under a standardized curriculum recognized as adequate by the FDA, under a program that is at least equivalent to that standardized FDA-approved curriculum, or be otherwise qualified through job experience.

Thus, a qualified individual must have completed a standardized FDA-approved curriculum or be equally qualified through other training or job experience. Unfortunately, no standardized FDA-approved curriculum has yet been created or approved for FSMA. Likewise, with no FDA-approved curriculum it is not possible to determine what constitutes equivalent training or job experience.

FDA has entrusted the responsibility for creating the standardized curriculum to the Food Safety Preventative Controls Alliance (FSPCA), a private alliance of leaders in the industry, academia, and state and local food protection agencies. FSCPA is funded as part of an existing grant to the Illinois Institute of Technology (IIT). FDA will offer ongoing input as the curriculum is developed and will review the final product so that it can become an FDA-approved curriculum.

The first order of business of FSCPA is to develop a core curriculum and corresponding technical materials that will be designed particularly to help small and mid-size firms. Although the final rules are not anticipated to be published until sometime in 2015, FSCPA is proposing to finish the first draft of the curriculum in the third quarter in 2014. Once approved by FDA, FSCPA will run a pilot training program.

The ultimate goals are that the FSCPA will:

• Develop standardized Hazard Analysis and preventive controls training and distance education modules for food industry and regulatory personnel. It is planned that the first individuals who will receive the training are those individuals who will then go forth to train others. The second to receive the training will be federal and state regulatory inspectors. Finally, training will be made available to industry members.

• Design and deliver a state-of-the-art distance learning training portal at the IIT IFSH Moffett Campus in Bedford Park, IL. In addition to in-person training, it is anticipated that training will be offered online.

• Create a technical assistance network, such as a website community, where small- and medium-size food companies can go to for help with their preventative control or food safety plans.

• Develop commodity/industry sector-specific guidelines for preventive controls.

• Over time and as technology develops, assess knowledge gaps and research needs for further enhancement of preventive control measures.

• Identify and prioritize the need for, and compile, critical limits for widely used preventive controls

Once the curriculum is completed by FSCPA and then approved by FDA, it will be possible to actually determine who is a “qualified individual” for purposes of creating, implementing and overseeing a Hazard Analysis and risk-based preventative controls safety plan. Whether that individual is qualified by completion of an FDA-approved curriculum or is determined to be qualified due to training or job experience equivalent to that curriculum, human food and animal food manufacturers will then be able to effectively begin creating their required safety plans. 

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is comprised of a team of attorneys from every legal practice area and who each have a focused background in the food industry.