Qualified Facility Attestation Form Due Soon
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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:
- Guidance for Industry: Determination of Status as a Qualified Facility
- Qualified Facility Attestation of Animal Food Facility
- Instructions for Submitting Qualified Facility Attestation
- If Your Facility Is a Very Small Business or a Small (Or Very Small) Farm Mixed-Type Facility, What PC Animal Food Rule Exemptions/Modified Requirements Apply to You?
If you have questions about qualified facility attestations or the Preventive Controls for Animal Food rule, please contact Marissa Herchler.
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