In addition to the definitions set forth in 21 CFR Part 112, the following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Anniversary Date--The last day following two years from the issuance of a Qualified Exemption.

(2) CFR--Code of Federal Regulations.

(3) Department--The Texas Department of Agriculture.

(4) Egregious condition--A practice, condition, or situation on a covered farm or in a packing facility that is undertaken as part of a covered activity that directly causes, or is likely to directly cause: (A) serious adverse health consequences or death from the consumption of or exposure to covered produce; or (B) an imminent public health hazard.

(5) FDA--United States Food and Drug Administration.

(6) Inspection--An initial or follow up inspection conducted by TOPS for the purpose of inspecting covered produce, a covered farm, or records related to the Produce Safety Rule.

(7) Produce Safety Rule--21 CFR Part 112: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, including any additions, amendments or revisions thereto.

(8) Raw agricultural commodity (RAC)--The term "raw agricultural commodity" is defined in Section 201(r) of the Federal Food, Drug and Cosmetic Act and means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. See 21 U.S.C. §321(4) and 21 CFR §112.3.

(9) TOPS--Texas Office of Produce Safety.

Source Note: The provisions of this §11.1 adopted to be effective September 11, 2019, 44 TexReg 4855