Qualified Facility Attestation Form Due Soon

— Written By
en Español / em Português

El inglés es el idioma de control de esta página. En la medida en que haya algún conflicto entre la traducción al inglés y la traducción, el inglés prevalece.

Al hacer clic en el enlace de traducción se activa un servicio de traducción gratuito para convertir la página al español. Al igual que con cualquier traducción por Internet, la conversión no es sensible al contexto y puede que no traduzca el texto en su significado original. NC State Extension no garantiza la exactitud del texto traducido. Por favor, tenga en cuenta que algunas aplicaciones y/o servicios pueden no funcionar como se espera cuando se traducen.


Inglês é o idioma de controle desta página. Na medida que haja algum conflito entre o texto original em Inglês e a tradução, o Inglês prevalece.

Ao clicar no link de tradução, um serviço gratuito de tradução será ativado para converter a página para o Português. Como em qualquer tradução pela internet, a conversão não é sensivel ao contexto e pode não ocorrer a tradução para o significado orginal. O serviço de Extensão da Carolina do Norte (NC State Extension) não garante a exatidão do texto traduzido. Por favor, observe que algumas funções ou serviços podem não funcionar como esperado após a tradução.


English is the controlling language of this page. To the extent there is any conflict between the English text and the translation, English controls.

Clicking on the translation link activates a free translation service to convert the page to Spanish. As with any Internet translation, the conversion is not context-sensitive and may not translate the text to its original meaning. NC State Extension does not guarantee the accuracy of the translated text. Please note that some applications and/or services may not function as expected when translated.

Collapse ▲

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.

Sign up for FDA Center for Veterinary Medicine (CVM) updates right to your inbox.

Sign up for NC State Feed Milling updates right to your inbox.