For companies seeking to comply with requirements of the Food Safety Modernization Act (FSMA), developing and putting into practice new processes and procedures may not be enough. Many companies will also need to train their employees using FDA-approved curricula and have their food safety plans developed by “qualified individuals” who have successfully completed agency-approved training in the development and application of risk-based preventive controls.
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Following last year’s publication of the final rules for five of the seven major FSMA regulations, industry now is under varying deadlines (depending on company size) to embrace new manufacturing processes and requirements for testing, monitoring, recordkeeping, and reporting. All these are designed to ensure that safety is built into every link of the food chain, from raw materials, to transportation, to storage. And employee education and training will become a key, mandatory component of this process.
The Preventive Controls Rule for Human Food (sections on current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls), for example, specifies that education and training are no longer simply recommended but are binding. “Management is required to ensure that all employees who manufacture, process, pack, or hold food are qualified to perform their assigned duties,” FDA says in a guidance document. “Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.”
The agency recognizes it plays a pivotal role in devising and making this training available to industry. To do so, FDA is working with public and private alliances and establishing cooperative agreements to develop and deliver training curricula for domestic and foreign businesses. “One size doesn’t fit all. The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements,” the agency says.
Because of this, FDA has adopted a three-pronged training development strategy. The first involves using already-established alliances funded primarily by FDA to develop and facilitate curricula for industry training. The second involves funding of cooperative agreements to develop training options for local food production systems and tribal operations. The third involves partnering with USDA’s National Institute of Food and Agriculture (NIFA) to provide grants to establish a National Coordination Center (NCC) and four Regional Centers (RCs) that provide training for small food processors, small fruit and vegetable merchant wholesalers, and farms.
FDA will soon begin issuing guidance documents detailing the core criteria, learning objectives, and elements recognized for these training programs. “This is critical because the standardized curricula being developed by the alliances and the alternate curricula to be developed through cooperative agreements are the only ones that will be officially recognized by the FDA,” explains David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods.
Essential to crafting the training curricula are efforts by the following three public-private alliances.
Produce Safety Alliance. This partnership created in 2010 between Cornell University, USDA, and FDA is developing standardized training to assist the domestic and foreign produce industry (including small and very small farms) and regulatory personnel to implement the Produce Safety Rule. The alliance will also develop a “train-the-trainer” course to certify trainers to support the produce industry.
Food Safety Preventive Controls Alliance. Initiated in 2011 and coordinated by the Illinois Institute of Technology’s Institute for Food Safety and Health, this alliance is developing a standardized training and education program along with a technical information network to help companies comply with the preventive controls rules for human and animal food and the Foreign Supplier Verification Program. Efforts will include standardized training courses, distance education modules, and other resources to help companies develop food safety plans, conduct hazard analyses, and implement preventive controls including how to monitor, verify, take corrective actions, and document such efforts.