Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed

Description

FDA believes that the intent of this cooperative agreement is to fund an entity that has active working relationships with local food producers, processors, or enterprises and/or organizations that have demonstrated experience developing and providing science-based, culturally specific food safety training, education and outreach, for local food producers and processors, with an emphasis on those that are involved in diversified, sustainable, organic and identity-preserved agricultural operations; beginning and socially disadvantaged farmers; value-added farm businesses and small-size processors; and direct and intermediate supply chain participants. The local food producers and processors targeted by this cooperative agreement may or may not be covered under FSMA (e.g., due to sales or distribution channels), however, should handle commodities relevant to these regulations. Subcontracts to other organizations that meet the intent noted above are encouraged. It is expected that applicants will specifically include collaboration between and among national and regional food safety leaders; relevant diversified, sustainable, organic and identity-preserved agricultural businesses or organizations; colleges, universities and related land grant cooperative extension programs; and regional and local food sector organizations, among others, to reach the intended audience. In addition, applicants are expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances and other organizations deliver FSMA education and outreach. Extensive cooperation and coordination with FDA CFSAN and other FDA program offices, Regional Centers (administered under the USDA-NIFA Food Safety Outreach Program), state agencies implementing FSMA, and the United States Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among local food producer stakeholders is also expected. The primary objective of this cooperative agreement is to provide training, education, and outreach, address training gaps (e.g., by developing training materials) and to facilitate identification of appropriate technical assistance resources for local food producers and processors related to applicable federal preventive controls regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules. Research to evaluate the program should also be completed, which includes data collection and analysis, to assess the impact of education, outreach and technical assistance on addressing training/knowledge gaps of the target audience previously identified. This cooperative agreement should also support development and delivery of alternate curricula for the FSMA Produce Safety Rule. Subcontracts to other organizations interested or engaged in developing and/or delivering alternate curricula training to this target audience are encouraged to meet this objective. In addition, consideration should be given to local food producers not currently subject to the regulatory requirements but that have conveyed an interest in or have identified economic incentives to comply (i.e., marketplace requirements to comply or business growth outlooks) with such regulations.Program Area Description FSMA was signed into law in 2011 and provided FDA with a legislative mandate to require comprehensive, prevention-based controls across the food supply along with other prevention-focused tools in order to create substantial improvements in the Agency’s approach to food safety. Standards that FDA is directed to issue under FSMA include hazard analysis and risk-based preventive controls for both human food and animal food and standards for produce safety, among other rulemaking and guidance development activities. The regulations include requirements for training and employee qualifications.Additionally, FSMA calls for enhanced partnerships and integration with FDA’s food safety Federal, State, local, tribal and territorial partners in order to achieve public health goals. To this end, the Agency has been working with such partners to develop and implement an integrated food safety system. To be successful, a national integrated food safety system must build upon the work currently being done by FDA and our regulatory and public health partners. Additional work is needed in terms of active communication, coordination, and support. One important step towards implementing a national integrated food safety system will entail the education, outreach, training and understanding technical assistance needs for local food producers that grow, harvest, pack or hold produce or process foods. Additionally, it is FDA’s role and responsibility to collaborate with other food regulatory agencies, and to support state, local and tribal regulatory and public health programs working to meet these standards.To build and maintain a national integrated food safety system, outreach and training related to FSMA will continue to be necessary to support local food producers and food manufacturer/processors. FDA anticipates that local food producers and processors will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific practices associated with produce farming and food manufacturing/processing relevant to their scale of production and management practices. Additionally, these local food stakeholders frequently have limited access to adequate and affordable food safety training, education, outreach, and technical assistance. FDA will engage in a cooperative agreement with one or more collaborators that develop and implement food safety training, education, and outreach to key local food stakeholders, including farmers, packers and manufacturers/processors that grow, harvest, pack and hold produce and process food affected by FSMA. It is expected that existing training materials, such as the standardized curriculum developed by the Produce Safety Alliance or the Food Safety Preventive Controls Alliance, would be used as a foundation for customization, where appropriate, to meet local food producer needs. In addition, the Sprout Safety Alliance will be a resource for existing training materials specific to sprout growers. Customization of these existing training materials, or development of alternate curricula when warranted to address training gaps, would likely address specific needs of the local food producers and processers, regional practices and needs, including addressing specific practices associated with produce farming and food manufacturing/processing relevant to local food stakeholders scale of production and management practices. FDA intends to work with the recipient to ensure that alternate curricula are recognized by FDA. Research to evaluate and assess the impact of education, outreach and technical assistance on addressing training/knowledge gaps of the target audience. The applicant would be expected to collaborate with FDA, USDA and other educational partners as appropriate to complete the program evaluation.Applicants are also expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances and other organizations that deliver FSMA education and outreach. Participation in regional and national meetings covering FSMA training and outreach (such as the FDA-USDA FSMA Collaborative Training Forum) is also expected.This cooperative agreement is beneficial to public health because it will further drive compliance with the final federal preventive controls regulations, especially the Produce Safety and Preventive Controls for Human Food rules; will help ensure consistency of implementation throughout the United States; will leverage existing expertise and knowledge; and will ultimately reduce foodborne illness. The program will focus on helping local food producer and processor audiences understand and interpret Federal food safety agricultural production and processing regulations and guidance enacted under FSMA, address challenging topics related to implementation of both the Produce Safety and Preventive Controls for Human Food (e.g., sanitation controls, wash water management, writing a food safety plan) thus enabling them to implement those regulations and guidelines in their respective environments. The program will provide training, education, and outreach, and build capacity and infrastructure, as well as alternate curriculum development and/or adaptation of the standardized curriculum, in addition to identifying technical assistance resources for local food producer and processor audiences impacted by FSMA regulations and guidance.

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