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FDA Draft Classification of Activities as Harvesting, Packing, Holding, or ManufacturingProcessing for Farms and Facilities

蒋千琴 2/25/2022 浏览 331 FDA United States

标准简介

Draft Classification of Activities as Harvesting, Packing, Holding, or ManufacturingProcessing for Farms and Facilities[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。

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Draft Classification of Activities as Harvesting, Packing, Holding, or ManufacturingProcessing for Farms and Facilities[附网盘链接]
Draft Classification of Activities as Harvesting, Packing, Holding, or ManufacturingProcessing for Farms and Facilities[附网盘链接](截图)

 

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标准文档类型为Draft Classification of Activities as Harvesting, Packing, Holding, or ManufacturingProcessing for Farms and Facilities[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft-Not for Implementation Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: 1

Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration's (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction 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 2

for Registration of Food Facilities (21 CFR part 1, subpart H). 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 1

This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition in cooperation with the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. Food and Drug Administration. 2

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. 3

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