Are You a Qualified Facility Under the FSMA Preventive Controls for Human Food Rule?
New Hampshire food business owners, if you manufacture, process, pack, or hold human food you may be subject to the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule under 21 CFR part 117. UNH Cooperative Extension has a number of on-line resources and tools that describe FSMA and help business owners determine whether they have to comply with the regulation. In addition to some of the currently featured resources, the FDA has created another document to support the food industry.
In September 2018, FDA released Determination of Status as a Qualified Facility guidance document to help businesses determine whether they meet the definition of a qualified facility. Within the guidance document, the FDA specifically addresses human food businesses that meet the requirements of a qualified facility and provides important deadline information. Some of the information highlighted in the document includes:
- the definition of a qualified facility,
- calculations to help businesses determine their status as a qualified facility,
- a description of acceptable record keeping, and
- example calculations to help businesses determine the market value of food held without sale.
If your human food business averages less than $1,000,000 in sales (adjusted for inflation per year) during the preceding 3 years, you may meet the definition of a qualified facility. If your business averages less than $500,000 (adjusted for inflation per year) during the preceding 3 years and you sold more than half of all food directly to consumers or to a restaurant and/or retail food establishment in-state or within 275 miles of the facility, you may also meet the definition of a qualified facility. Owners, if your business is also a farm, there may be a simpler path to compliance for you. Please visit the https://extension.unh.edu/resource/does-preventive-controls-rule-fsma-apply-you-online-tool online tool to learn more about the requirements.