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U.S. Department of Health and Human Services

Food

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Determining Regulatory Authority for Antimicrobial Substances

Decision Tree for Determining whether any Particular Antimicrobial Intervention for Food is Regulated by the Environmental Protection Agency or the Food and Drug Administration

Text Version
 

Question: Where are the microbes that the antimicrobial intervention is intended to control?Question 1: When in or on raw agricultural commodies, or in water that contacts raw agricultural commodies, is the antimicrobial treatment in a food processing facility, or during transportation to such a facilityFrom question 1: Yes. The antimicrobial substance is regulated as a food additive by the Food and Drug Administration.  It may also be subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, by EPA
From question 1: No.  The antimicrobial substance is regulated as a pesticide chemical under the Federal Food, Drug, and Cosmetic Act and is subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, both by EPA
Question2:  When in or on a processed food, is the antimicrobial substance being applied either ethylene oxide or propylene oxide?From question2: Yes.  The antimicrobial substance is regulated as a pesticide chemical under the Federal Food, Drug, and Cosmetic Act and is subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, both by EPA.
From question2: No.  The antimicrobial substance is regulated as a food additive by the Food and Drug Administration.
Question 3: When in or on a food-contact article, where on the food-contact article does the substance exert its antimicrobial effect?From question3:  If in or on any type of food packaging, the antimicrobial substance is regulated as a food additive by the Food and Drug Administration.  It may also be subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, by EPA.
Question 4: When on the surface of food-contact articles & equipment other than food packaging, where on the food-contact article does the substance exert its antimicrobial effect?From question4: If on the surface of food-contact articles & equipment other than food packaging, the antimicrobial substance is regulated as a pesticide chemical under the Federal Food, Drug, and Cosmetic Act and is subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, both by EPA.
Question 5:  When on any part of the food-contact article other than the surface, or if it has no effect in or on the finished food contact article, where on the food-contact article does the substance exert its antimicrobial effect?.From question5:  If On any part of the food-contact article other than the surface, or if it has no effect in or on the finished food contact article, the antimicrobial substance is regulated as a food additive by the Food and Drug Administration.  It may also be subject to registration as a pesticide under Federal Insecticide, Fungicide and Rodenticide Act, by EPA.

 

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