The Food Safety Modernization Act (FSMA) was signed into law in 2011 and establishes that all domestic and foreign food facilities that are required to register with the U.S. Food and Drug Administration (FDA) as a food facility must comply with the requirements for risk-based preventive controls mandated by FSMA as well as the Current Good Manufacturing Practices of this rule (unless an exemption applies).  

Title 21, Part 117, Code of Federal Regulations (CFR), which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.

Under 21 CFR 117, a “qualified facility” is a facility that is exempt from some parts of the rule: Subpart C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and Subpart G (Requirements for a Supply-Chain Program).

What Is a Qualified Facility?

21 CFR 117 defines a “qualified facility” as (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate):

• A facility that is a very small business.
  • 117.3 defines a “very small business” as a business, including any subsidiaries and affiliates, averaging less than $1 million, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale (e.g., held for a fee).

OR

• A facility to which both of the following apply:
  • During the three-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
  • The average annual monetary value of all food sold during the three-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

Qualified Facility Attestation

To be in compliance with the modified requirements in Subpart D, a facility must submit an attestation to FDA (Form 3942a). Facilities that qualify for the modified requirements found in 21 CFR 117.201 must submit an attestation to FDA that:

• The facility is a qualified facility per the definition in 21 CFR 117.3;

AND

• The facility has identified potential hazards and is implementing controls to address the hazards, and monitoring the performance of preventive controls to ensure that such controls are effective (21 CFR 117.201(a)(2)(i));

OR

• The facility complies with applicable non-federal food safety law, including relevant laws and regulations of foreign countries (21 CFR 117.201(a)(2)(ii)).

The Guidance for Industry: Determination of Status as a Qualified Facility and the Qualified Facility Attestation form are available on the FDA website. The initial submission deadline was December 17, 2018. All businesses that have attested are subject to the modified requirements starting in January 2019.

Beginning in 2020, you must resubmit Form 3942a to FDA every two years during the food facility biennial registration renewal period beginning on October 1 and ending on December 31 (21 CFR 117.201(c)(2)(ii)). Note that you must also renew your facility registration at this time (21 CFR 1.230). You can submit the Qualified Facility Attestation form electronically or by mail:

• To submit electronically, go to fda.gov/furls. Locate FURLS Qualified Facility Attestation (QFA), select the information, and follow the instructions.
• To submit by mail or other delivery service, send the completed paper form to U.S. Food and Drug Administration (HFS-681), 5001 Campus Drive, College Park, MD 20740.

Please note that facilities must have a valid food facility registration to submit their attestation.

Additional Information

Qualified facilities are exempt from the preventive control requirements in 21 CFR 117 Subpart C and supply-chain program in 21 CFR 117 Subpart G. The following requirements apply to qualified facilities:

• 21 CFR 117 Subpart A — General Provisions: Consists of definitions, exemptions, applicability, and requirements for qualified individuals.
• 21 CFR Subpart B — Current Good Manufacturing Practices
• 21 CFR Subpart D — Modified Requirements: Includes the modified requirements that apply to a qualified facility and a facility solely engaged in the storage of unexposed packaged food.
• 21 CFR Subpart F — Records Requirements: Includes requirements for employee training records and record retention.