Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities | Guideline Explorer

Description

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.

Scope & Applicability

Product Classes

5

RACs

Raw Agricultural Commodities such as apples, cocoa beans, and garlic

human food

Substances used in human food evaluated for safety.; Substances intended for use in food for humans.

animal food

Substances used in animal food evaluated for safety.; Substances intended for use in food for animals.

Raw Agricultural Commodity

Sprouts in their raw or natural state

Processed Food

Food transformed from its RAC state, not subject to the rule

Stakeholders

5

farm

Entity type defined for regulatory exemptions

mixed-type facility

Establishment that conducts both farm and non-farm activities

Primary production farm

Operation under one management devoted to growing crops; Farm that grows, harvests, and/or raises commodities

Secondary activities farm

Operation devoted to harvesting, packing, and holding

Farm Mixed-Type Facility

Establishment that is a farm but also conducts activities requiring registration; establishments that engage in both farm and non-farm activities

Regulatory Context

Attributes

1

majority ownership

Criteria for defining a secondary activities farm

Identified Hazards

Hazards

1

Pathogen Growth

Risk associated with damaged portions of RACs that may require trimming

Related CFR Sections (7)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read full regulation →
21CFR1.225§ 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United StatRead full regulation →
21CFR1.227§ 1.227 What definitions apply to this subpart?
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, for the purposes of this subpart:Read full regulation →
21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
21CFR117.95§ 117.95 Holding and distribution of human food by-products for use as animal food.
(a) Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor, as identified in § 507.12 of this chapter , must be held under conditions that will protect against contamination, including the following:Read full regulation →
21CFR507.12§ 507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food.
(a) Except as provided by paragraph (b) of this section, the requirements of this part do not apply to by-products of human food production, or the off-farm packing and holding of raw agricultural commodities, that are packed or held by that human food facility for distribution as animal food if:Read full regulation →

Related Warning Letters (10)

CGMP/Animal Food/Adulterated
King Farm
2025-12-23
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
2025-11-11
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
2025-10-28
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
2025-09-30
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
2025-09-09
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
2025-08-26
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
2025-08-19
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
2025-07-15