This form is for use in conjunction with Section 9 Food Facility and Farm Mixed-Type Facility Requirements. Supporting information for specific elements can be attached to this form.
When performed on food crops, activities such as size reduction, extraction, and sometimes dehydration are regulated by FDA as food processing that is subject to good manufacturing practice (GMP) regulations, even if they occur on a farm (in which case the farm is defined by FDA as a “farm mixed-type facility” that is generally required to register with FDA). The regulations in 21 CFR Part 117 form the foundation of U.S. food safety regulations; reproduced below are the requirements established in Part 117 for facilities, equipment, and personnel.
Food facilities and farm mixed-type facilities that process conventional foods and/or dietary supplements for distribution in the U.S. are required to comply with 21 CFR Part 117 and/or Part 111, as well as other FDA regulations as applicable, even if the facilities are located outside the US.
The following sections outline the minimum requirements for facilities, equipment, and personnel required under Part 117 for processors of conventional foods and dietary supplements. Operators of food facilities and farm mixed-type facilities must consult the full text of Part 117 and Part 111, as well as other FDA regulations as applicable, to determine the appropriate additional requirements for their operations.