Proposed FDA Rule for Sanitary Transportation

What does the new (FDA) Proposed Rule on Sanitary Transportation of Human and Animal Food say about the Transportation of “Shelf-Stable Food”?

The Proposed Rule would define “shelf-stable food” to mean a food that can be stored under ambient temperature and humidity conditions and, if the package integrity is maintained will not spoil or become unsafe throughout its storage life.  The proposed rule would define “transportation” as any movement of food in commerce by motor vehicle and, further define “transportation operations” to mean all activities associated with food transportation that may affect the sanitary condition of food including the cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment.

The Proposed Rule contains the following exclusions:

  1. Transportation operations associated with the transportation solely of shelf stable food that is completely enclosed by a container.
  2. Transportation of raw agricultural commodities that is performed by a farm.
  3. Transportation of compressed food gases.
  4. Transportation of live food animals.
  5. Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales

The FDA’s findings indicated that shelf stable food should be excluded from being regulated by the Proposed Rule because they are completely enclosed by a container are at little risk of adulteration during transportation, as they do not require temperature control and as such, are not at risk of microbial spoilage or the growth of microorganisms of public health significance, and they are not directly exposed to the transportation environment due to their being fully enclosed by their container, e.g. a metal can, a glass or plastic bottle, or a sealed bag or box.

The proposed rule applies to food shippers, carriers and receivers, “whether or not the food is offered for or enters interstate commerce.” For purposes of the proposed rule, food includes human food, dietary supplements, animal food, raw materials, and ingredients (including packaging), and food subject to the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.

The Public comment period has concluded, so it will be interesting to see if any further changes are made before the final rule is enacted.