21 CFR 117 Subpart D - Modified Requirements

What it says

Subpart D provides modified requirements for certain facilities. A qualified facility, which includes a very small business as defined in the rule, is not required to meet the hazard analysis, risk-based preventive controls and supply-chain program requirements. Instead it submits an attestation to FDA, either that it has identified potential hazards and is implementing and monitoring preventive controls, or that it complies with applicable non-federal food safety law, and it must tell consumers the name and address of the facility on its labeling or at the point of purchase. A facility solely engaged in storing unexposed packaged food also has modified requirements.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Qualified facility status is not a general exemption. Current good manufacturing practice requirements still apply, so sanitation, personnel and plant controls are still inspected.
• Status depends on the facts and has to be reviewed regularly, so a facility that grows or changes its customers can lose it.
• The attestation to FDA is a formal statement, so the records behind it need to be kept and the statement renewed on the schedule the rule sets.

What FDA inspectors look for

• Whether the facility can document why it qualifies, including the sales and other figures behind its status.
• Whether the attestation was submitted and kept current, and whether the statements in it match actual practice.
• Whether current good manufacturing practice is followed regardless of status.

Related regulations