Potential Implications of FDA Rule on Indian Country Food and Agriculture

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On June 24,2024,  the U.S. Food and Drug Administration (FDA) hosted an all Tribes’ call for Tribal leaders, their staff, and interested parties to hear about the recently published final rule Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water issued by the Center for Food Safety and Applied Nutrition. The rule was first proposed in December 2021 and is effective July 5, 2024. 

The call was not a Tribal consultation, but allowed FDA’s subject matter and intergovernmental affairs staff to describe the implications of the final rule, including how it was shaped through feedback from an open comment period. During the call, the FDA reported public comments they received on the final rule, including input from state and foreign governments. While the FDA held a Tribal consultation to hear from Indian Country on its potential impact in February 2022, the limited feedback provided there did not factor in the final rule’s implementation. According to the FDA, all comments received through the consultation comment window were reviewed and considered in the final rule’s development. 

  • Read the ‘Dear Tribal Leader’ with complete background information here. 

On May 6, 2024, the FDA published the final rule that replaces the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts). It establishes requirements for systems-based assessments, with required testing in certain circumstances, that focus on key risk factors for contamination by pre-harvest agricultural water.  

The effective date for the new final rule is July 5, 2024. 

Tribal implications  

The final rule replaces testing requirements that farms reported to be complex and challenging to 

implement. The former testing requirements focused on annual systems-based pre-harvest agricultural water tests to identify and address water contamination.  

  • The lack of comments on the new rule from Indian Country may reflect reality that it does not immediately impact most Tribes and Tribal producers due to the size and structure of many Tribal operations. Many Tribal producers are qualified for exemption from the rule. They may fall under the exception category of operations with an average annual value of produce sold during the previous three-year period of $25,000 or less 
  • Although the produce safety rule may not currently apply to many Tribal growers, the fundamental practices outlined in the rule form the foundation for the U.S. Department of Agriculture’s Good Agricultural Practices (GAP). Furthermore, the rule’s guidelines encourage good on-farm food safety practices, which protect businesses, community members, Tribal members and citizens. By following the rule’s spirit, Tribal growers will be acclimated to standards they may become subject to if they expand operations in the future.  
  • Tribal growers that wish to continue GAP and good on-farm food safety practices may need to update their compliance with this rule, and Tribes seeking compliance with this rule may need additional produce safety training resources.  
  • The new rule reduces testing requirements but will require covered Tribal growers to keep detailed records of their determinations of risk factors, risk mitigation, and corrective actions to comply with the rule. 
  • By reducing testing requirements, the rule requires covered Tribal growers to make determinations based on “reasonable” and “foreseeable” standards, which may not be sensitive to Tribal cultural considerations.  

Tribes and Tribal producers with questions about the new rule have multiple resources at their disposal. The Indigenous Food and Agriculture Initiative’s Enterprise Team works closely with the Producer Safety Network and Tribal agriculture operations nationwide. Their support and technical knowledge are free of charge for Tribal governments and producers in need. 


Additionally, FDA has two Tribal liaisons who can assist with internal challenges or inquiries.  

Oscar Galagarza, Tribal Nations liaison for the FDA’s Produce Safety Network 

Division of Produce Safety – Fresh Produce Branch 

Office of Food Safety – FDA 



Paul R. Allis, M. Ed, Sr., Intergovernmental / Tribal Affairs Specialist 

Office of Policy, Legislative, and International Affairs 

Office of the Commissioner – FDA 



Additional resources 


The mission of IFAI focuses on putting Tribal sovereignty in food sovereignty, promoting Tribally driven solutions to revitalize and advance traditional food systems and diversified economic development throughout Indian Country. IFAI provides Tribal governments, producers, and food businesses with educational resources, policy research, and strategic legal analysis as a foundation for building robust food economies.