§112.3. What definitions apply to this part? — Inbound Citations

The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, the following definitions apply to words and phrases as they are used in this subpart:

(e) If you are importing a raw agricultural commodity that is a fruit or vegetable that is “covered produce” as defined in § 112.3 of this chapter, you are not required to determine whether there are any biological hazards requiring a control in such food because the biological hazards in such fruits or vegetables require a control and compliance with the requirements in part 112 of this chapter significantly minimizes or prevents the biological hazards. However, you must determine whether there are any other types of hazards requiring a control in such food.

(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with an average annual monetary value of produce (as “produce” is defined in § 112.3) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as the baseline year for calculating the adjustment, is a “covered farm” subject to this part. Covered farms subject to this part must comply with all applicable requirements of this part when conducting a covered activity on covered produce.

(1) During the previous 3-year period preceding the applicable calendar year, the average annual monetary value of the food (as defined in § 112.3) the farm sold directly to qualified end-users (as defined in § 112.3) during such period exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and