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

Description

Purpose and Priorities The Food and Drug Administration's (FDA), Center for Food Safety and Applied Nutrition (CFSAN), is announcing its intent to renew a Cooperative Agreement with an estimated amount of $500,000.00 (direct and indirect costs) for fiscal year 2023. It is anticipated that future years of support will be available, depending on annual appropriations and successful performance. 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. Subcontracts to organizations that meet the intent noted above are encouraged. It is expected that the applicant 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 expected to collaborate with the established FDA Food Safety Modernization Act (FSMA) Alliances. Extensive cooperation and coordination with FDA CFSAN and other FDA program offices, the National Coordination and Regional Centers (established under the “National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program”), and FDA’s FSMA partners at the U.S. Department of Agriculture (USDA) and other Federal organizations that have a vested interest in food safety among tribal stakeholders is also expected. The primary objective of this cooperative agreement is to develop and provide training, education, outreach, and 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. 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 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 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, new training related to FSMA will need 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, 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 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 and customized curricula are recognized by FDA. This cooperative agreement is beneficial to public health because it would further drive compliance with the final federal preventive controls 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 and interpret new 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 begin with assessing needs, capacity and infrastructure, building and evolving to curriculum development and/or adaptation delivering training, education and outreach as well as identifying technical assistance resources for tribal audiences impacted by the new food safety regulations and guidance. The other preventive controls rules are available on FDA's website at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm, or upon request. Program Area Priorities This cooperative agreement is intended to develop and deliver training and outreach, develop and provide educational materials using the FSMA Alliance materials as a foundation, and facilitate identification of appropriate technical assistance resources for tribes subject to the applicable preventive controls regulations. The goal of developing and delivering this training, educational material and outreach is to: enhance the fundamental knowledge of food safety and especially on-farm good agricultural practices of tribal stakeholders subject to applicable FSMA regulations. Applications must address all of the following: Demonstrate an ability to reach the target audience and an ability to collaborate and lead relevant partners that also work with the target audience on relevant areas. Such partners include tribal academic institutions, tribal governments, land grant cooperative extension, federally recognized tribal extension agents, tribal NGOs and community-based organizations, and federal agencies with a role in food safety such as the USDA, Centers for Disease Control and Prevention, and the Indian Health Service; Demonstrate an ability to develop and implement a training plan that includes project goals that shall significantly advance tribal stakeholders understanding of on-farm produce and food manufacturing/processing safety, taking into account existing materials and also specific cultural practices within tribes and regions, and ultimately increase understanding of the requirements of the Produce Safety and Preventive Controls for Human Food rules as well as other federal preventive controls standards to facilitate and support compliance; Conduct a training, education, and technical assistance needs assessment so that training, education, and outreach can be prioritized within the scope of this cooperative agreement and appropriate resources for technical assistance can be identified; Develop science-based, culturally appropriate training, outreach and educational materials and tools, around the FSMA regulations, especially the Produce Safety rule and Preventive Controls for Human Food rule, for federally recognized tribes. Targeted training and educational materials will be based upon existing produce and human food safety training and educational materials (e.g., FSMA Alliances) to the extent practicable and will address sp

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