Under the Food Safety Modernization Act (FSMA), facilities that manufacture, process, pack, or store food for animals are required to comply with the Preventive Controls rule. Among other things, this rule requires facilities to implement a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plan and develop and maintain a supply chain program.
As of today, September 17, 2019, qualified facilities including very small businesses are now required to comply with the Preventive Controls rule unless they submit a Qualified Facility Attestation (QFA) to the U.S. Food and Drug Administration (FDA). Facilities that have been producing animal food products since before September 17, 2019 have until December 16, 2019 to submit their initial attestation. Those that will begin producing after this date must submit attestation before beginning operations. According to FDA, qualified facilities including very small businesses will be able to submit their QFAs through FURLS beginning on October 1, 2019. Following this initial deadline, facilities must provide attestation to FDA between October 1 and December 31 of every even numbered year.
What is a ‘Very Small Business’?
FDA defines a very small business (also known as a qualified facility) as a business “averaging less than $2,500,000 adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale”. The QFA is written documentation proving that the business meets FDA’s definition of very small business.
If a very small business does not provide FDA with an attestation, it will be required to have a Food Safety Plan and a supply chain program, if applicable. Registrar Corp can help you determine if your facility meets the criteria for a qualified facility.
Complying with FSMA
Because both Current Good Manufacturing Practices (cGMPs) and the Preventive Controls rules are new for animal food producers, FDA staggered the compliance dates for the two components. Regulated animal food facilities of all sizes are expected to maintain cGMPs and all deadlines to comply with cGMPs have passed. cGMPs cover basic food safety requirements, such as proper cleaning, maintaining equipment, and pest control.
FDA plans to check for compliance with cGMPs and Preventive Controls requirements during routine inspections. According to FDA, the Agency plans to enforce these rules during inspections of very small animal food businesses in 2020. FDA will still enact regulatory action against a facility if an issue, such as a food emergency, arises. If a facility fails to submit QFA by the December 19 deadline and is not otherwise exempt, FDA will expect the facility to have a proper HARPC Food Safety Plan and supply chain program in place, and may issue a regulatory notice if they find the requirements are not met.
Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help your facility navigate QFA requirements as part of our registration and U.S. Agent services. Our Food Safety Specialists can also help your facility develop a Food Safety Plan and your Supply Chain program. For more information, please contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.