Covered farm; covered produce; exemptions.

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§145-32 Covered farm; covered produce; exemptions. [See Note at part heading.] (a) Covered produce is eligible for exemption from the requirements of this part under the following conditions:

(1) The covered produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance;

(2) The covered farm discloses in documents accompanying the covered produce, that in accordance with the practice of the trade, the food is "not processed to adequately reduce the presence of microorganisms of public health significance";

(3) The covered farm complies with the written assurance requirements of title 21 C.F.R. section 112.2(b)(3);

(4) The covered farm complies with the documentation requirements of title 21 C.F.R. section 112.2(b)(4);

(5) The requirements of title 21 C.F.R. part 112 subpart A (general provisions) and title 21 C.F.R. part 112 subpart Q (compliance and enforcement) apply to the covered produce; and

(6) An entity that provides a written assurance under title 21 C.F.R. section 112.2(b)(3) acts consistently with the assurance and documents its actions taken to satisfy the written assurance.

(b) A covered farm shall comply with all applicable requirements of this part, rules adopted pursuant to section 145-39, and title 21 C.F.R part 112 when conducting a covered activity on covered produce. A farm is not subject to this part if it satisfies the requirements in title 21 C.F.R. section 112.5 and the United States Food and Drug Administration has not withdrawn the farm's exemption in accordance with the requirements of title 21 C.F.R. part 112 subpart R.

(c) A farm is eligible for a qualified exemption and associated modified requirements in a calendar year if:

(1) The average annual monetary value of the food the farm sold directly to qualified end-users during the previous three-year period preceding the applicable calendar year exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and

(2) The average annual monetary value of all food the farm sold during the three-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, using 2016 as the baseline year for calculating the adjustment for inflation.

If a farm is eligible for a qualified exemption in accordance with title 21 C.F.R. section 112.5, the farm shall be subject to the requirements of title 21 C.F.R. part 112 subparts A, O, Q, and R. If a farm is eligible for a qualified exemption in accordance with title 21 C.F.R. section 112.5, the farm shall be subject to the modified requirements established in title 21 C.F.R. section 112.6(b).

(d) No covered farm or farm eligible for a qualified exemption in accordance with title 21 C.F.R. section 112.5 shall violate any provision of this part, rules adopted pursuant to section 145-39, or title 21 C.F.R. part 112. [L 2019, c 103, pt of §2]


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