§1.227. What definitions apply to this subpart? — Inbound Citations

(9) Manufacturer means the last facility, as that word is defined in § 1.227, that manufactured/processed the food. A facility is considered the last facility even if the food undergoes further manufacturing/processing that consists of adding labeling or any similar activity of a de minimis nature. If the food undergoes further manufacturing/processing that exceeds an activity of a de minimis nature, then the subsequent facility that performed the additional manufacturing/processing is considered the manufacturer.

The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part.

(3) Of food when it is located in food facilities as defined in § 1.227 of this chapter, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

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:

(2) Determine whether measures are reasonably necessary to reduce the potential for contamination of covered produce or food contact surfaces with such known or reasonably foreseeable hazards.

Agricultural water system means a source of agricultural water, the water distribution system, any building or structure that is part of the water distribution system (such as a well house, pump station, or shed), and any equipment used for application of agricultural water to covered produce during growing, harvesting, packing, or holding activities.

Animal excreta means solid or liquid animal waste.

Application interval means the time interval between application of an agricultural input (such as a biological soil amendment of animal origin) to a growing area and harvest of covered produce from the growing area where the agricultural input was applied.

Biological soil amendment means any soil amendment containing biological materials such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea, or yard trimmings, alone or in combination.

Biological soil amendment of animal origin means a biological soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts including animal mortalities, or table waste, alone or in combination. The term “biological soil amendment of animal origin” does not include any form of human waste.

Composting means a process to produce stabilized compost in which organic material is decomposed by the actions of microorganisms under thermophilic conditions for a designated period of time (for example, 3 days) at a designated temperature (for example, 131 °F (55 °C)), followed by a curing stage under cooler conditions.

Covered activity means growing, harvesting, packing, or holding covered produce on a farm. Covered activity includes manufacturing/processing of covered produce on a farm, but only to the extent that such activities are performed on raw agricultural commodities and only to the extent that such activities are within the meaning of “farm” as defined in this chapter. Providing, acting consistently with, and documenting actions taken in compliance with written assurances as described in § 112.2(b) are also covered activities. This part does not apply to activities of a facility that are subject to part 117 of this chapter.

Covered produce means produce that is subject to the requirements of this part in accordance with §§ 112.1 and 112.2. The term “covered produce” refers to the harvestable or harvested part of the crop.

Curing means the final stage of composting, which is conducted after much of the readily metabolized biological material has been decomposed, at cooler temperatures than those in the thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition. Curing may or may not involve insulation, depending on environmental conditions.

Direct water application method means using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces during use of the water.

Farm means:

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

(1) The exemption in paragraph (g)(3) of this section applies to packing or holding of processed foods on a farm mixed-type facility, except for processed foods produced by drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), the packing and holding of which are within the “farm” definition in § 1.227 of this chapter. Activities that are within the “farm” definition, when conducted on a farm mixed-type facility, are not subject to the requirements of subparts C and G of this part and therefore do not need to be specified in the exemption.

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:

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

(a) This part does not apply to establishments, including “farms” (as defined in § 1.227 of this chapter), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.