FDA has finalized guidance to help facilities determine their business size under the Preventive Controls for Human Food and Preventive Controls for Animal Food rules issued in response to the FSMA.

Under these rules, a facility that qualifies as a small business may have a later compliance date, and certain activities performed by a farm mixed-type facility that is a small business are exempt from the preventive controls requirements in the rules.  

A small business is defined in the rules as a business (including any subsidiaries and 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. The guidance will help companies understand what “full-time equivalent employee” means, as well as how a business with subsidiaries or affiliates can determine number of employees.

Download the guidance at www.fda.gov/media/111951/download.