FDA issues draft guidance to help small businesses with FSMA
Small businesses subject to the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules, which include provisions mandated by the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), may be eligible for certain exemptions and have later compliance dates than larger businesses covered by the rules.
Small businesses subject to the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules, which include provisions mandated by the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), may be eligible for certain exemptions and have later compliance dates than larger businesses covered by the rules.
A “small business” is defined in the rules as 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. But what does “full-time equivalent employee” mean? And if you have a business with multiple subsidiaries or affiliates how should you go about determining your number of employees?
The FDA has issued a draft guidance issued to provide the agency’s current thinking on these questions. The draft guidance explores key terms such as “subsidiary,” “affiliate,” and “full-time equivalent employee.” It also offers a method for calculating full-time equivalent employees, and examples of the types of situations businesses might encounter when trying to determine their number of employees.