Description
The purpose of this document is to state the intent of the Food and Drug Administration (FDA, we, or the Agency) not to enforce the requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (21 CFR Part 112) as they apply to entities growing, harvesting, packing and holding certain commodities.
Scope & Applicability
Product Classes
4Commodity included in the enforcement policy scope; Commodity commercially produced primarily in California.
Commodity included in the enforcement policy scope; Dry, edible seeds of plants in the legume family.
Commodity subject to enforcement discretion policy; Grape varietals grown, harvested and used solely for wine.
Commodity subject to enforcement discretion policy
Stakeholders
3Entities providing feedback to FDA regarding RCR list.
Firms that may have fewer resources for reformulation
Compliance date category for the Produce Safety Rule
Identified Hazards
Hazards
1Pathogens that commercial processing must adequately reduce
Related CFR Sections (3)
- 21CFR112.1§ 112.1 What food is covered by this part?
(a) Unless it is excluded from this part under § 112.2 , food that is produce within the meaning of this part and that is a raw agricultural commodity (RAC) is covered by this part. This includes a produce RAC that is grown domestically and a produce RAC that will be imported or offered for import iRead full regulation →
- 21CFR112.2§ 112.2 What produce is not covered by this part?
(a) The following produce is not covered by this part:Read full regulation →
- 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 →
Related Warning Letters (10)
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
- 2025-06-10
Foreign Supplier Verification Program (FSVP)
Gongora USA Corp
- 2025-06-03
Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jack & The Green Sprouts, Inc.
- 2025-06-03
Foreign Supplier Verification Program (FSVP)
Amore Produce, LLC
- 2025-06-03
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Everything Sprouts, LLC
- 2025-05-27
Foreign Supplier Verification Program (FSVP)
San Juan Produce LLC
- 2025-05-27
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Wailea Agricultural Group, Inc.
- 2025-03-25
Foreign Supplier Verification Program (FSVP)
Gonzar Produce, LLC
See Also (8)
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Status: Draft)
- Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Status: Draft)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)