As outlined by 21 CFR Part 117, the number of full-time equivalent employees for a given facility is determined by dividing the total number of hours worked in one year by all of the business’s staff (including those that do not handle food and those employed by affiliates and subsidiaries) by the number of hours one full-time employee would work in one year (i.e. 2,080).
For example, a facility may employ 150 full-time employees at 40 hours per week and 200 part-time employees at 30 hours per week for food manufacturing roles (a total of 624,000 hours in a year). The facility may be a division of a legal entity that employs 150 full-time employees and an additional 250 part-time employees across multiple subsidiaries for various roles unrelated to food manufacture (an additional 702,000 hours in a year). Though the facility only has 150 full-time employees, the legal entity it comprises actually has 637 full-time equivalent employees (1,326,000 hours divided by 2,080).
For this reason, some facilities may not realize that they are actually subject to requirements for large businesses under the Preventive Controls Rules.
