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Produce vs frozen reefer loads: which federal food rules apply

Helm PartnersUpdated Oct 30, 2026Sources checked Oct 30, 2026

This guide is general information, not advice on any policy.

Short answer

FDA's sanitary transportation rule, 21 CFR Part 1 Subpart O, covers most produce and frozen food hauls. Hauls done by a farm are excluded. So is food fully enclosed in containers, unless it needs temperature control for safety. For those loads the shipper sets the operating temperature and pre-cooling in writing. Food at facilities regulated only by USDA falls under USDA rules such as 9 CFR 325.1.

In this guide
  • Who Subpart O covers
  • Produce loads
  • Frozen and other temperature-controlled loads
  • Where USDA rules apply
  • FAQ

Who Subpart O covers

Shippers, receivers, loaders and carriers of food, interstate or not, except non-covered businesses and listed exclusions (21 CFR 1.900).

Produce loads

  • Hauls performed by a farm are outside the rule (21 CFR 1.904).
  • Open baskets, open boxes and vented cases are food not completely enclosed by a container, so the rule applies.
  • Raw foods must be kept from contaminating other food in the same load (1.908(a)(3)).

Frozen and other temperature-controlled loads

  • Enclosed food is excluded, except food that requires temperature control for safety.
  • For that food the shipper gives the carrier an operating temperature and pre-cooling in writing.
  • The carrier pre-cools as specified and shows temperature data on request. See reefer pre-cooling and temperature records.

Where USDA rules apply

  • Food in facilities regulated only by USDA under the Federal Meat Inspection Act, Poultry Products Inspection Act or Egg Products Inspection Act is outside Subpart O (1.900(b)(3)).
  • Unwrapped meat moves only in enclosed conveyances with tight doors, free of dirt, rust and chemical residues (9 CFR 325.1(c)).

Related: the FSMA sanitary transportation rule for reefer carriers, the agricultural HOS exemption for produce, the reefer cargo claim file checklist.

FAQ

Is produce hauled by a farm covered?

No. Transportation activities performed by a farm are not transportation operations under 21 CFR 1.904.

Are boxed produce loads covered?

Produce in open or vented cases is not completely enclosed, so it stays in scope. Fully enclosed food is excluded unless it needs temperature control for safety.

Who sets the reefer temperature?

The shipper, in writing, for food that needs temperature control for safety (21 CFR 1.908(b)(2)).

What about meat and poultry?

Food in facilities regulated only by USDA under the meat, poultry or egg products acts is outside Subpart O (1.900(b)(3)). 9 CFR 325.1 requires clean, enclosed conveyances for unwrapped meat.

Does this page cover pharmaceuticals?

No. Subpart O is a food rule, and we have not reviewed drug transport rules here.

This guide is general information, not advice on any policy.

Sources