#### § 1.904 What definitions apply to this subpart?

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:

*Adequate* means that which is needed to accomplish the intended purpose in keeping with good public health practice.

*Animal food* means food for animals other than man, and includes pet food, animal feed, and raw materials and ingredients.

*Bulk vehicle* means a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.

*Carrier* means a person who physically moves food by rail or motor vehicle in commerce within the United States. The term carrier does not include any person who transports food while operating as a parcel delivery service.

*Cross-contact* means the unintentional incorporation of a food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act into food, except animal food.

*Farm* has the meaning given in § 1.227 of this chapter.

*Food not completely enclosed by a container* means any food that is placed into a container in such a manner that it is partially open to the surrounding environment. Examples of such containers include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag. This term does not include food transported in a bulk vehicle as defined in this subpart.

*Full-time equivalent employee* is a term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (*i.e.,* 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.

*Loader* means a person that loads food onto a motor or rail vehicle during transportation operations.

*Non-covered business* means a shipper, loader, receiver, or carrier engaged in transportation operations that has less than $500,000, as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year. For the purpose of determining an entity's 3-year average revenue threshold as adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.

*Operating temperature* means a temperature sufficient to ensure that under foreseeable circumstances of temperature variation during transport, *e.g.,* seasonal conditions, refrigeration unit defrosting, multiple vehicle loading and unloading stops, the operation will meet the requirements of § 1.908(a)(3).

*Pest* means any objectionable animals or insects including birds, rodents, flies, and larvae.

*Receiver* means any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.

*Shipper* means a person, *e.g.,* the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.

*Small business* means a business employing fewer than 500 full-time equivalent employees except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to § 1.900(a) having less than $27,500,000 in annual receipts.

*Transportation* means any movement of food in by motor vehicle or rail vehicle in commerce within the United States.

*Transportation equipment* means equipment used in food transportation operations, *e.g.,* bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and unloading systems. Transportation equipment also includes a railcar not attached to a locomotive or a trailer not attached to a tractor.

*Transportation operations* means all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment. Transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container except a food that requires temperature control for safety, compressed food gases, food contact substances as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act, human food byproducts transported for use as animal food without further processing, or live food animals except molluscan shellfish. In addition, transportation operations do not include any transportation activities that are performed by a farm.

*Vehicle* means a land conveyance that is motorized, *e.g.,* a motor vehicle, or that moves on rails, *e.g.,* a railcar, which is used in transportation operations.