The purpose of this guidance is to help industry subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine the number of employees for purposes of the "small business" definition under parts 117 and 507.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
This guidance concerns two regulations that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). These two regulations are part 117 (published in the Federal Register on September 17, 2015, 80 FR 55907) and part 507 (published in the Federal Register on September 17, 2015, 80 FR 51670).
Among other things, the rulemaking to establish part 117 amended our CGMP regulation for manufacturing, packing, or holding human food to modernize it and establish it in new part 117, primarily in subpart B, with associated requirements in subparts A and F. Part 117 also includes new requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d), primarily in subparts C and G, with associated requirements in subparts A, D, E, and F, to establish and implement hazard analysis and risk-based preventive controls for human food (the human preventive controls requirements). The rulemaking to establish part 507 created new animal food CGMP and preventive controls requirements for domestic and foreign facilities that are required to register under section 415 of the FD&C Act. Requirements for CGMPs are primarily in part 507, subpart B, with associated requirements in subparts A and F (CGMP requirements). Requirements for establishing and implementing hazard analysis and risk-based preventive controls for food for animals are primarily in subparts C and E, with associated requirements in subparts A, D, and F (the animal food preventive controls requirements).
Under parts 117 and 507, whether a business is a "small business" has two main implications. First, certain small businesses (i.e., "farm mixed-type facilities," which are establishments that are farms, but also conduct activities outside the farm definition that require the establishments to be registered) are exempt from the human food preventive controls requirements and the animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations. Second, small businesses have later compliance dates for parts 117 and 507 than larger businesses.
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.