Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed

The intent of this cooperative agreement is to fund an entity that has active working relationships with Native American tribes and/or organizations that have demonstrated experience developing and providing science-based, culturally specific food safety training, education, outreach, and technical assistance for tribes, tribal businesses, and/or tribal members, with an emphasis on agricultural production and human food manufacturing/processing. The Native American produce farmers 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 organizations that meet the intent noted above are encouraged. It is expected that applicants will specifically include collaboration between and among national and regional tribal stakeholder leaders, relevant tribal organizations, tribal colleges and universities and associated national organizations; as well as land grant cooperative extension programs, and other organizations and partners involved in national food safety efforts, in order to reach the intended audience. In addition, applicants are encouraged to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances and other organizations that 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 (FSOP)), the U.S. Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among tribal stakeholders is also encouraged, including FSOP grants targeting tribes. Participation in regional and national meetings covering FSMA training and outreach (such as the FDA-USDA FSMA Collaborative Training Forum) is also expected.The primary objective of this cooperative agreement is to provide training, education, outreach, address training gaps (e.g., by developing training materials) and to facilitate identification of appropriate technical assistance resources to produce farming and food manufacturing/processing members of federally recognized tribes related to the applicable federal regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules. In addition, consideration should be given to tribal stakeholders 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. 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 agreement focuses primarily on the standards for Produce Safety and Preventive Controls for Human Food rules; however, more broadly all regulations under FSMA should be considered by the applicant, as any may apply to tribal members based on their specific operation.Program Area DescriptionFSMA 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 requirements for 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, an integrated national 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 an integrated national food safety system will entail training, education, outreach and understanding technical assistance needs for tribal members that grow, harvest, pack or hold produce, or process foods. Among other roles, it is FDA’s role and responsibility to collaborate with other food regulatory agencies, but to also assist through incentives or other means state, local and tribal regulatory and public health programs working to meet these standards.To build an integrated national food safety system, the need for outreach and training related to FSMA will continue to be available to tribal produce farmers, packers and food manufacturers/processors. FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations. Additionally, these tribal 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 will develop and implement food safety training, education, outreach and identification of technical assistance resources for key tribal stakeholders, including farmers, packers and manufacturers/processors that grow, harvest, pack and hold produce, and process food impacted 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/modification, where appropriate, to meet tribal needs. In addition, the Sprout Safety Alliance will be a resource for existing training materials specific to sprout growers. Customization/modification of these existing training materials would likely address regional practices and needs, including addressing specific tribal practices associated with produce farming and food manufacturing/processing. 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.This cooperative agreement is beneficial to public health because it would further drive compliance with the final federal preventive control regulations, especially the Produce Safety and Preventive Controls for Human Food rules; would help ensure consistency of implementation throughout the United States; would leverage existing expertise, knowledge, and enforcement authorities of tribal regulatory staff; and ultimately reduce foodborne illness.The program will focus on helping tribal audiences understand Federal food safety agricultural production and processing regulations and guidance enacted under FSMA, 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 tribal audiences impacted by FSMA regulations and guidance.The other preventive controls rules are available on FDA's website at, or upon request.

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Food and Drug Administration
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