21 CFR Part 108: Emergency Permit Control
Part 108 of title 21 runs to 9 sections across 2 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 9
- Subparts
- 2
- Words of regulation
- 5,862
- Current to
- 2026-09-10
What this clause controls in practice
A food safety plan controls one hazard under 21 CFR part 108, and FDA food recalls name a botulism risk in 350 enforcement records since 2012. That is where the clause belongs, not a finding against any firm named below: a recall record states a reason, and most FDA food recalls are initiated by the firm itself.
Recent records naming one of those hazards:
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-07-29 | Brooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box distributed between 04/01/2026 and 06/20/2026. | Brooklyn Roasting Works LLC | Ambient storage of the product may lead to Clostridium botulinum toxin formation. | Class II |
| 2026-07-08 | a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918 | NARA ORGANICS INC | Product may be contaminated with Clostridium botulinum. | Class I |
| 2026-07-01 | Dried Herring Fish 7 oz. | Prime Food Processing LLC. | Improperly eviscerated which may result in Clostridium botulinum contamination | Class I |
| 2026-06-10 | Hellas Meze Golden Smoked Whole Herring | Terra Medi LLC | Un-eviscerated fish may be contaminated with clostridium botulinum | Class I |
| 2026-05-27 | Menopause Bully 16 oz and 32 oz. | LIQUID BLENZ CORP | May be under-processed resulting in growth of Clostridium botulinum and lists health claims. | Class II |
| 2026-05-27 | Fibroid Bully 16 oz and 32 oz. | LIQUID BLENZ CORP | May be under-processed resulting in growth of Clostridium botulinum and lists health claims. | Class II |
| 2026-05-27 | Prostate Bully 16 oz and 32 oz | LIQUID BLENZ CORP | May be under-processed resulting in growth of Clostridium botulinum and lists health claims. | Class II |
| 2026-05-27 | Blackseed Bitters 16 oz and 32 oz. | LIQUID BLENZ CORP | May be under-processed resulting in growth of Clostridium botulinum and lists health claims. | Class II |
Subpart A: General Provisions
- 108.3 Definitions5
- 108.5 Determination of the need for a permit6
- 108.6 Revocation of determination of need for permit2
- 108.7 Issuance or denial of permit3
- 108.10 Suspension and reinstatement of permit5
- 108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit2
- 108.19 Establishment of requirements for exemption from section 404 of the act2
Subpart B: Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit
Read 21 CFR part 108 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 108 cover?
- 21 CFR part 108 is Emergency Permit Control. It runs to 9 sections across 2 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
- Which hazards does 21 CFR part 108 control?
- A food safety plan controls a botulism risk under part 108. Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
Every section of part 108 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.