Description
This guidance is intended for farms subject to theStandards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)(21 CFR Part 112). For certain farms, the Produce Safety Rule provides a qualified exemption; qualified exempt farms are subject to modified rule requirements. During the COVID-19 public health emergency as declared by the Secretary of the U.S. Department of Health and Human Services (HHS), FDA providedcertain temporary flexibilities related to eligibility criteria for the qualified exemptionExternal Link Disclaimer. This document communicates FDA’s current thinking on how, when the COVID-19 public health emergency expires, qualified exempt farms may transition away from those temporary policies and back to the qualified exemption eligibility criteria as established in the Produce Safety Rule.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Fruit or vegetable including mushrooms, sprouts, and herbs
Stakeholders
4Specific buyers such as consumers, restaurants, or retail food establishments.
Farms eligible for specific exemptions under the Produce Safety Rule.
Entities subject to the Produce Safety Rule
Consumer, restaurant, or retail food establishment meeting specific distance or location criteria
Regulatory Context
Regulatory Activities
1Regulatory requirements for growing, harvesting, packing, and holding of produce; regulation governing sprout production safety; The Produce Safety Rule does not require microbial testing of seeds for sprouting; The Produce Safety Rule does not prohibit the use of proprietary seed treatments; requirements of the Produce Safety Rule for environmental monitoring; Regulation governing the standards for sprout production; Regulation governing the sampling and testing requirements for sprouts.; The o
Document Types
2Notice announcing the availability of the draft guidance
performing label review for each new batch
Attributes
2The total food sales threshold for qualified exemption eligibility.
Financial threshold for determining covered farm status
Technical Details
Clinical Concepts
1Public health emergency response mentioned as a precedent
Identified Hazards
Hazards
1Public health concern causing travel restrictions and impracticability of onsite activities.
Related CFR Sections (4)
- 21CFR112.5§ 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?
(a) A farm is eligible for a qualified exemption and associated modified requirements in a calendar year if:Read full regulation →
- 21CFR112.7§ 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5 ?
If your farm is eligible for a qualified exemption in accordance with § 112.5 :Read full regulation →
- 21CFR112.6§ 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5 ?
(a) If your farm is eligible for a qualified exemption in accordance with § 112.5 , you are subject to the requirements of:Read full regulation →
- 21CFR112.3§ 112.3 What definitions apply to this part?
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 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.
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)
- Small Entity Compliance Guide: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Status: Final)
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Status: Final)
- Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government (Status: Final)
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption (Status: Draft)
- Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)