Produce Safety Proposed Rule Q & A

The Produce Safety Proposed Rule defines “farm” as:

The proposed rule would define “farm” to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. “Farm” includes (i) facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
Table 3 in the proposed produce rule preamble (in section V.A.2.b.i, at 78 FR 3543-4) provides examples of activities and their classification. For more information, we encourage you to read section V.A.2.b.i of the proposed produce rule preamble (starting at 78 FR 3539), and section VIII of the proposed preventive controls rule preamble (starting at 78 FR 3674), which includes the most detail on this topic.
The proposed rule would define “farm” and “mixed-type facility”. Farms and farm mixed-type facilities that have an average annual monetary value of food sold during the previous 3-year period of more than $25,000 (on a rolling basis) would be “covered farms” under the proposed rule, unless they are eligible for the qualified exemption (see below) and FDA has not withdrawn their qualified exemption. The proposed rule would not apply to farms that have an average annual value of food sold during the previous 3-year period of $25,000 or less. FDA notes, however, that these farms are and will continue to be covered under the adulteration provisions and other applicable provisions of the FD&C Act, whether or not they are included within the scope of this proposed rule.
As required by Food Safety Modernization Act, certain farms would be exempt from most of the requirements of the proposed rule and would instead be subject to modified requirements. This qualified exemption could be withdrawn under certain circumstances. The following farms would be eligible for the qualified exemption: Farms for which, during the previous 3-year period preceding the applicable calendar year: The average annual monetary value of the food sold directly to qualified end-users during such period exceeded the average annual value of the food sold to all other buyers during that period; AND
The average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.

Submit written or electronic comments by 16 May 2013.

 

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