The U.S. Food and Drug Administration (FDA) released a draft guidance document to assist businesses in determining their business size for complying with Food Safety Modernization Act (FSMA) rules.
The FSMA rules for current good manufacturing practice and preventive controls for human food and animal food define a “small business” to be a business (including any subsidiaries or affiliates) employing fewer than 500 full-time equivalent employees. The limit of 500 employees includes all employees of the business and is not limited to the employees at a particular facility.
Under the two rules, 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 the rules than larger businesses.
The draft guidance document contains information about how to determine which employees of a business are to be included when making a full-time equivalent employee calculation and illustrates the process through several examples.