Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities


How to Comment

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.

Submit electronic comments on to docket number FDA-2016-D-2373.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852. 
All comments should be identified with the docket number FDA-2016-D-2373.

Contains Nonbinding Recommendations
Draft-Not for Implementation

August 2016

This guidance is being distributed for comment purposes only.

The purpose of this guidance is to help you to determine whether the activities that you perform are within the “farm” definition. The regulatory framework for determining whether your business is a “farm” depends in large part on certain definitions (i.e., the definitions for “farm,” “mixed-type facility” (including a “farm mixed-type facility”), “harvesting,” “packing,” “packaging,” “holding” and “manufacturing/processing”) that are established in our regulation for Registration of Food Facilities (21 CFR part 1, subpart H)[see note]. For your convenience, we copied these definitions that are established in 21 CFR 1.227 into sections II.B and II.C of this guidance.

The guidance includes several examples of hypothetical operations that conduct various activities. We developed the hypothetical examples to make certain points about the regulatory framework for determining whether the activities that you perform are within the “farm” definition. To make these points, in some cases our hypothetical examples describe activities that may not be common in today’s farming operations. It would not be possible to address every conceivable circumstance that may be relevant to determining whether the activities that you perform are within the “farm” definition. However, our intent was to provide information that will be helpful to you in evaluating your own operations.

Note: The definition of “manufacturing/processing” includes “packaging” as an example of a “manufacturing/processing” activity. In this guidance, we often discuss packaging separately from manufacturing/processing even though packaging is a manufacturing/processing activity. This is because “packaging” is common on farms and the “farm” definition specifically provides for “packaging” as a manufacturing/processing activity that is within the “farm” definition.

Download the Draft Guidance for Industry (PDF (247KB)

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