US Cold Chain Compliance — FSMA, FDA & USDA Buyer Guide
The US regulatory stack: FSMA / 21 CFR 117, USDA-FSIS for meat and poultry, FDA for seafood and dairy, AIM Act for refrigerants, ASHRAE 15 and IIAR for NH₃ plants.
The US splits food-safety oversight between FDA (most foods) and USDA-FSIS (meat, poultry, processed egg). FSMA (2011) shifted the model from reaction to prevention, requiring written food-safety plans and preventive controls. Refrigerant compliance is federalised under the AIM Act, mirroring EU phase-down. NH₃ plants trigger OSHA PSM.
Why this regulation matters
A missing FSMA plan or FSIS inspection sticker blocks interstate commerce and closes the export corridor to the EU/UK/Japan.
Who must comply
US-domestic cold storage, importers, exporters into the US, and any foreign supplier under FSMA FSVP.
FSMA rules relevant to cold storage
Preventive Controls for Human Food (PCHF), Sanitary Transportation of Human & Animal Food (STF), Foreign Supplier Verification Programs (FSVP), and Food Traceability (204). Each rule has separate compliance dates and record-keeping expectations.
Common buyer mistakes
- ✕Confusing FDA and USDA-FSIS jurisdictions (product category decides).
- ✕No PCQI (Preventive Controls Qualified Individual) on record.
- ✕Ignoring state-level codes (California CalARP for ammonia).
Buyer compliance checklist
- FDA food-facility registration (renewed biennially).
- Written food-safety plan under 21 CFR 117 with PCQI signature.
- USDA-FSIS grant of inspection for meat/poultry.
- OSHA PSM programme for NH₃ >10,000 lb.
- AIM Act-compliant refrigerant procurement records.
- State FDA cold-storage licence (varies by state).
Frequently asked
Does FSMA apply to foreign suppliers?
Yes — through the FSVP rule. US importers must verify that their foreign suppliers produce food that meets US safety standards, or the shipment is refused entry.
Submit one RFQ and we'll help you identify qualified international suppliers — vendor-neutral, buyer-first.
Submit a verified RFQEducational content for buyers. Not legal advice — confirm current requirements with local counsel, notified bodies and the competent authority before contract award.