21 CFR Part 1 is the FDA's General Enforcement Regulations, a broad part covering topics such as food facility registration, prior notice of imported food, and FSMA Sanitary Transportation in Subpart O.
Detailed Definition
21 CFR Part 1 holds the FDA's General Enforcement Regulations. It is split into subparts that cover very different programs, including food facility registration, prior notice of imported food, the Foreign Supplier Verification Program, the Sanitary Transportation of Human and Animal Food rule in Subpart O, and the FSMA Section 204 food traceability rule in Subpart S. For pallet users, Subpart O is the part that matters most, because it sets sanitation and temperature-control duties for the equipment used to move food.
How Subpart O touches pallets
The Sanitary Transportation rule places duties on shippers, loaders, carriers and receivers of human and animal food. It requires that vehicles and transportation equipment be designed, maintained and cleaned so they do not make food unsafe, and that temperature-controlled food is kept at the right temperature. The rule's definition of transportation equipment is broad and includes items used to move food, such as pallets and pallet jacks.
In practice, a shipper or loader is expected to check that pallets under exposed or vulnerable food are clean, dry and free of pests, odors and damage that could contaminate the load.
What a food shipper should document
Subpart O expects written procedures and records for some activities, plus training for carrier personnel when the carrier is responsible for sanitary conditions. A pallet program in a food supply chain usually covers:
- which pallet types and conditions are acceptable for each product
- inspection at receiving and before loading
- how rejected pallets are segregated
- who is responsible for sanitation under the shipping agreement
Check the current rule text on eCFR and FDA guidance, since exemptions and responsibilities depend on the type of business and food.
Related Glossary Terms
Frequently Asked Questions
Does 21 CFR Part 1 require a specific type of pallet?
No. Subpart O does not name a pallet material, grade or design. It requires that transportation equipment, which includes pallets, be in sanitary condition and suitable for the food being moved. Wood, plastic and other pallets can all be used if they are clean, sound and appropriate for the product. Many food companies set their own pallet specification on top of the rule.
Who is responsible for pallet condition under the sanitary transportation rule?
Responsibility depends on the role each party plays and on written agreements between them. The shipper generally sets sanitary requirements, the loader checks equipment before loading, the carrier follows agreed procedures, and the receiver checks the load on arrival. If a contract assigns tasks differently, that agreement should be in writing and records kept as the rule requires.