FDA’s FSMA: Small Businesses Might Be Eligible for Exemptions and Later Compliance Dates

The FDA has been assisting food and beverage companies in assimilating with the Food Safety Modernization Act (FSMA) in time for their compliance dates by releasing several explanatory draft guidances. On March 19, the FDA released a new draft guidance that details potential exemptions and extended FSMA compliance dates for businesses that are subject to the Preventative Controls for Human Food (PCHF) and Preventative Controls for Animal Food (PCAF) rules, if they qualify as “small businesses.”

The draft guidance was developed to assist companies in determining whether or not they qualify as “small business” under the Preventative Controls regulations. According to the document, “small businesses” are defined as companies with a total of 500 or less full-time employees, which includes employees from any company subsidiaries or affiliates. This means that all full-time employees from all faculties owned by a company must be included in the 500-employee limit.

To help businesses calculate whether or not they qualify for these exemptions, the draft provides definitions for “small businesses,” “full-time equivalent employee,” “subsidiary,” “affiliate,” and “facility.” In addition, the draft guidance provides companies with an algorithm that allows them to calculate their total number of full-time employees.

“All employees of the legal entity that includes the facility, as well as its subsidiaries and affiliates, should be counted regardless of whether they are engaged in covered food activities.  Examples of non-food activities employees could be engaged in include retail operations, management, accounting, or marketing,” s said the guidance .

The FSMA was signed by into law by President Obama on January 4, 2011 for the purpose of ensuring the safety of the US food supply. The act allows federal regulators to respond to and prevent food contamination in the US food industry.

Since the introduction of the FSMA, food companies have been facing stricter guidelines for the manufacturing of their products. However, by ensuring the safety of their products food companies can build consumer trust and loyalty.