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Is My Operation a “Qualified Facility” Under FDA’s Preventive Controls Rules?

September 21, 2018

Small food business owners may be exempt from some of the rules in the food safety modernization act if they meet the requirements of a qualified facility. Photo Credit: USDA

Small food business owners may be exempt from some of the rules in the Food Safety Modernization Act if they meet the requirements of a qualified facility. Photo Credit: USDA

Are you a small food business owner interested in a partial exemption from some of the new Food Safety Modernization Act (FSMA) rules? Under the Preventive Controls Rules for Human and Animal Food, a “qualified facility” is exempt from the Hazard Analysis and Risk-based Preventive Controls (HARPC) and the Supply Chain Program requirements. Recently, the Food and Drug Administration (FDA) finalized the attestation forms that allow businesses to confirm their status as a qualified facility.

Businesses interested in confirming their qualified facility status should note the upcoming deadline for submitting an attestation form.

FDA also released two related documents: Instructions for filling out the attestation forms and final guidance for the Determination of Status as a Qualified Facility (“Qualified Facility Guidance”). These documents provide additional information for businesses who are unsure about whether or not they are a qualified facility.

The Qualified Facility Guidance and the submission of an attestation form do not apply to businesses that are exempt from all of the Preventive Controls Rules. To learn more about exempt businesses, read the National Sustainable Agriculture Coalition’s (NSAC) post Who is Subject to FDA’s New FSMA Food Facilities Rule? – Part 1. This post focuses on the Preventive Controls Rule for Human Food, but it is also relevant for the Preventive Controls Rule for Animal Food.

Step 1: Confirm Your Business Meets the Definition of a Qualified Facility

First, you need to determine whether or not you fall under the qualified facility definition. Read NSAC’s resources Who is Subject to FDA’s New FSMA Food Facilities Rule? – Part 2 or the Understanding FDA’s FSMA Rule for Food Facilities report to determine whether or not your business falls under the definition of a qualified facility and what regulations qualified facilities are still required to follow.

The Qualified Facility Guidance can provide additional clarification for businesses about the qualified facility definition. NSAC commented on the draft of the Quality Facility Guidance and commends FDA for adopting most of our recommendations.

Most businesses seeking qualified facility status fall under the “very small business” part of the qualified facility definition. A very small business is any business with less than $1 million in annual food sales, subject to inflation, based on an average of the preceding three years’ sales.

The Qualified Facility Guidance focuses on the very small business part of the qualified facility definition. However, there is a second part of the qualified facility definition, which requires a facility to sell a majority of their food products to qualified end-users and have an annual average of less than $500,000 in food sales during the preceding three calendar years. The final guidance adopts NSAC’s comment to include language referencing this second part. For the most part, those qualifying under the second part also qualify under the first; for more information on this second part of the qualified facility definition, see NSAC’s materials mentioned above.

The easiest way to determine whether or not a business qualifies as a very small business is to calculate its annual sales. Annual sales calculations should:

  • Include all sales of human food;
  • Occur every year, no later than July 1st;
  • Be based on the previous three calendar years, not the current year. Qualified facilities were required to start keeping records in 2016. FDA will accept a calculation of annual sales based on the prior two years for 2018. New businesses can base the calculations on any prior year until they have been in business for over three years; and
  • Adjust for inflation. NSAC requested a simpler method to adjust for inflation in our comments. In response, the complex method was removed, and FDA now posts the updated $1 million threshold, adjusted for inflation, here: FSMA Inflation Adjusted Cut Offs.

The Qualified Facility Guidance provides examples and details on how to calculate annual sales. At NSAC’s suggestion, the guidance includes a simple example of a calculation for a business that only sells human food. Then, there is a more complex example discussing how to calculate annual sales if a business sells both human and animal food.

Step 2: Submit an Attestation Form Before the December Deadline

Once you have confirmed your business falls within the qualified facility definition, you should submit an attestation form to the FDA. Qualified facilities selling human food should submit Form FDA 3942a. There is a different form for qualified facilities selling animal food.

The deadline for submitting an attestation form is December 17, 2018 if a business manufactured, processed, packed or held food before September 17, 2018. New businesses that begin after September 17, 2018, should submit the form on or before the date the business begins. Businesses can submit their attestation forms electronically, at https://www.access.fda.gov, starting on October 1, 2018.

Attestation forms must be resubmitted every two years between October 1st and December 31st.

If a business’ status changes from a “qualified facility” to “not a qualified facility,” the attestation form must be resubmitted to notify FDA of the change by July 31st of the calendar year when the change in status occurs.

FDA also released instructions on how to fill out an attestation form. FDA adopted the changes NSAC requested to reorganize the form and clarify the form’s instructions.

Step 3: Keep Records

There are several records qualified facilities must keep. Financial records should be kept for confirming status as a qualified facility.

A qualified facility must also keep records to prove proper food safety practices or compliance. These records should verify that either 1) the owner has identified, addressed, and is still monitoring potential hazards; or 2) the facility complies with any state, local, county, or tribal food safety laws.

The draft guidance failed to mention what types of records FDA will accept to prove proper food safety practices and compliance. The final Qualified Facility Guidance includes NSAC’s recommendation to list specific examples of these records. For example, to prove a business follows proper food safety practices, a food safety plan or a similar set of documents that identify hazards, preventive controls for those hazards, and the monitoring of preventive controls is sufficient.  If a business instead uses records of compliance with local and state food safety laws, the final Qualified Facility Guidance recommends keeping records of licenses, inspection reports, certificates, permits, etc.

If a business is supplying raw materials and ingredients to a receiving facility required to comply with all of the Preventive Controls rule, there are also records the supplier must provide to the receiving facility. The final guidance adopts NSAC’s comment to allow a receiving facility to rely on the qualified facility records for proving food safety practices and compliance, instead of an onsite audit. Suppliers should provide qualified facility records to a receiving facility each year.

The Qualified Facility Guidance also explains how FDA will verify a business’ qualified facility status. NSAC requested FDA include this information, which was left out of the draft guidance. FDA states they will not review financial records during routine inspections, but only during “for cause” inspections. The Qualified Facility Guidance states that a “for cause” inspection includes an inspection conducted because food from that facility is traced to a foodborne illness outbreak or if FDA has reason to believe a facility fails to meet the qualified facility requirements.

The Qualified Facility Guidance is an important reference for businesses searching for more information on recordkeeping and the qualified facility definition. While guidance documents are not legally binding, they are used to represent the agency’s current interpretation of a regulation.

Categories: Food Safety, General Interest

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