Qualified Facility Attestation Form Due Soon

— Written By

graphic reminder for the attestation form due date


If you qualify for an exemption under the qualified facility definition, the attestation form must be submitted to the FDA by December 16, 2019.

If you are a qualified facility and do not submit an attestation form to the FDA, you will be inspected on all the requirements of CFR 507, the Preventive Controls for Animal Food rule.

Business Size CGMP HA/PC Qualified Facility Attestation

Very Small Businesses

(< $2.5 million/year)

Sept. 17, 2018 Sept. 17, 2019 Dec. 16, 2019

Small Businesses

(<500 FTE)

Sept. 18, 2017 Sept. 17, 2018 N/A
All Others Sept. 19, 2016 Sept. 18, 2017 N/A

Are you a “qualified facility”, as defined by CFR 507.3?

Qualified Facility: 

Option 1: very small business; OR

Option 2: (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 as defined in this part, or a facility to which both of the following apply:

  • During the 3-year period preceding the applicable calendar year, the average 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 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

Qualified facilities are expected to comply with 21 CFR 507 subpart B: Current Good Manufacturing Practice (CGMP) and are subject to modified requirements for the Preventive Controls for Animal Food rule.

Modified requirements may include:

  • Addressing the hazards identified through preventive controls and monitoring the preventive controls; or
  • Complying with applicable non-federal food safety laws (including state food safety laws) and notifying consumers of the name and complete business address of the facility where the animal food was manufactured and/or processed.

For additional information about qualified facility attestations:

If you have questions about qualified facility attestations or the Preventive Controls for Animal Food rule, please contact Marissa Herchler.


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