As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered by these rules.

On March 19, 2018, FDA released a draft guidance to assist businesses in determining their size under the Preventive Controls regulations. 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 The draft guidance explains terms such as “subsidiary,” “affiliate” and “full-time equivalent employee.” It also provides a method for calculating full-time equivalent employees, and gives examples of the types of situations businesses might encounter when trying to determine their number of employees.

More information concerning about FDA’s final rule for Preventive Control for Human Food and for Preventive Controls for Animal Food can be found here and here.