Deadline for Eligible Animal Food Facilities to Submit Qualified Facility Attestations Approaching

• By: NEGFA
• On: 11/11/2019 13:19:08
• In: Regulatory Updates
• Comments: 0

Facilities that meet the definition of a “qualified facility” under the Preventive Controls for Animal Food (PC Animal Food) rule and that began manufacturing, processing, packing, or holding animal food before September 17, 2019 must submit an attestation form to FDA by December 16, 2019.
 
A facility that is a very small business is a qualified facility as defined in the PC Animal Food rule. Generally speaking, a very small business is one whose average annual sales of animal food plus the market value of animal food that is manufactured, processed, packed or held without sale during the previous three-year period is less than $2,500,000.
 
Qualified facilities are required to comply with the Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 507, subpart B (and related requirements in subparts A and F).  However, qualified facilities are exempt from the preventive controls requirements of the rule and instead have modified requirements.  These modified requirements include submission of  Form FDA 3942b, attesting that they meet the financial requirements to be a qualified facility and attesting that they are either:

• Addressing identified hazards 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 or processed.

Qualified facilities are required to maintain the records they rely on to support the attestations they make on Form FDA 3942b but those records do not have to be submitted to FDA along with the attestation.
 
If a qualified facility fails to notify FDA of its status by submitting its attestation form (Form FDA 3942b), FDA will inspect for all of the requirements found in the PC Animal Food regulation (part 507), including the preventive control requirements found in 21 CFR part 507, subparts C and E (with related requirements in subparts A and F).
 
Facilities that began manufacturing, processing, packing, or holding animal food before September 17, 2019 must submit their attestation by December 16, 2019.  Facilities that begin manufacturing, processing, packing or holding animal food after September 17, 2019 must submit their attestation before beginning operations. Beginning in 2020, attestation forms must be submitted to FDA every 2 years between October 1 and December 31, which is in conjunction with the requirement for biennial food facility registration renewal.

For More Information

• Guidance for Industry: Determination of Status as a Qualified Facility
• Qualified Facility Attestation for Animal Food Facility (Form FDA 3942b)
• 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?