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Food Safety for Qualified Exempt Food Producers to Build Economic Viability Under the Food Safety Modernization Act


The Food Safety Modernization Act (FSMA), passed into law on January 4, 2011, is the first major update of U.S. food safety programs since the Food, Drug, and Cosmetic Act was signed in 1938. While Small and Very Small Manufacturers are qualified to be exempt from parts of the rule, notably the need for a formal Hazard Analysis and Preventive Control Plan, these facilities are still required to follow the Current Good Manufacturing Practices as well as FSMA-specific requirements for record keeping and training of personnel. Attestation that shows a manufacturer to be qualified for exemption is necessary, including proper documentation demonstrating the company to be a small or very small business following the economic parameters enforced in the Act. Additionally, the manufacturer must also provide an attestation that the manufacturer has evaluated potential hazards associated with the foods produced and implemented record keeping and training activities related to these hazards. An alternative to this second requirement may be documentation showing the manufacturer to be under applicable non-Federal food safety regulations. Even though there are still questions regarding the details of how the regulation will be applied to these manufacturers and the requirements for local regulation to be deemed sufficient, there are clear and immediate needs that must be covered to ensure that qualified manufacturers are both compliant to FSMA requirements and are using processing conditions that ensure manufacturing of safe food, in accordance to the objectives of the Act. Therefore, the objectives of this project are to:i) Identify specific training needs of qualified exempt food producers to meet regulatory requirements, including exemption attestation under FSMA;ii) Develop and deliver training in principles of Food Safety including cGMPs to at least 50 qualified exempt producers in local urban and rural communities;iii) Conduct process evaluation and establish preventive control guidelines per food categories for regulatory record compliance by qualified exempt food producers.

Padilla-Zakour, Olga
New York Agricultural Experiment Station
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