FDA Releases Information for Companies Wishing to Claim 'Qualified Facility' Status

FDA released information for those facilities wishing to file as a Qualified Facility - very small business who only have to meet modified requirements (do not need to develop a formal Food Safety Plan) as defined within the Preventive Controls for Human (or Animal) Rule. 

Facilities must determine if they meet conditions for a Qualified facility and then must submit as attestation.   Starting October 1, 2018, facilities will be able to submit the qualified facility attestation forms electronically via the Qualified Facility Attestation Module.  Facilities must submit their first attestation to FDA by December 17, 2018, for facilities under Human Food and  December 16, 2019 for Animal Food.

1. Determine if you are a Qualified Facility - see this Guidance Document.
2. Follow instruction for submitting attestation form - See this FDA procedure
• Fill out this form for Human Food - Link to Human Food Attestation Form
• Fill out this form for Animal Food - Link to Animal Food Attestation Form

Or you can take a class and develop a Food Safety Plan like regular food companies.


FDA Releases Information for Qualified Facilities under Preventive Controls Rules
September 14, 2018
Today, the U.S. Food and Drug Administration issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities.

FDA Issues Draft Guidance on Qualified Facilities within the Preventive Controls Rule

As part of the Preventive Controls Rule, FDA establishes 'Qualified Facilities' as those facilities exempt from having to establish HACCP based systems (Preventive Controls), but only having to comply with GMPs. But in order to become 'Qualified', they must submit a form to FDA attesting to their status as 'Qualified". This guidance provides detail on how to submit the required form, Form FDA 3942.

‘Qualified Facility’’ as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or.
• Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-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).

You can access that document here.