On March 20, 2018, the U.S. Food and Drug Administration (FDA) issued guidance for industry regarding the definition of “small business” under Title 21 of the Code of Federal Regulations (21 CFR) parts 117 or 507 of the Food Safety Modernization Act (FSMA).

The guidance defines “small business” and outlines how an entity may determine if it meets the criteria. The guidance identifies specific exemptions for low risk activity and food related enterprises along with the extended compliance dates for the small business.

The guidance does not establish “any rights for any person and is not binding.” FDA states that the guidance “should be viewed only as a recommendation, unless specific regulatory or statutory requirements are cited.”

The Federal Register notice may be found here:

https://www.federalregister.gov/documents/2018/03/20/2018-05705/determining-the-number-of-employees-for-purposes-of-the-small-business-definition-in-parts-117-and

The guidance may be found here:

https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM600967.pdf