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  1. Food Safety Modernization Act (FSMA)

Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water


Due to laboratory capacity concerns, the U.S. Food and Drug Administration has worked with the U.S. Environmental Protection Agency to update the protocol that will aid in the development and registration of treatments for preharvest agricultural water. The update allows companies and other agricultural water stakeholders to use non-GLP (Good Laboratory Practice) data in their submissions, provided that the submissions accurately represents how the study differs from the GLP standards in the 40 CFR 160.12 statement of non-compliance. This action will give companies and other agricultural stakeholders access to more laboratories that can conduct the efficacy studies needed to aid in the registration of antimicrobial treatments for preharvest agricultural water. 

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA recognizes that effective treatments could be a valuable tool in helping to prevent foodborne illness associated with the consumption of produce. However, there are currently no registered antimicrobial treatment products that are authorized to control microorganisms of public health significance for use on agricultural fields, or for treatment of irrigation water systems or ponds.

A testing protocol, which is intended to help companies develop data on the effectiveness of their products in inactivating pathogens, such as E. coli or Salmonella, in preharvest agricultural water, was developed through a collaboration between scientists in FDA’s Center for Food Safety and Applied Nutrition and subject matter experts at the Environmental Protection Agency (EPA). EPA’s approval of this protocol means that companies and other agricultural water stakeholders may use the data developed using the protocol to support registration of new treatment products, or amendments to current products’ labels, for use against foodborne pathogens in preharvest agricultural water.

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