Description
This guidance concerns four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111–353).
Scope & Applicability
Product Classes
1Fruits and vegetables subject to produce safety regulation; Fruits or vegetables subject to produce safety regulation.; produce subject to the produce safety regulation
Stakeholders
4Establishment that manufactures/processes food exported to the US; Establishment that manufactures/processes food exported to the United States
entity that receives a product, raw material, or ingredient from a receiving facility
Must comply with registration if meeting facility/responsible person definitions
Entity responsible for submitting NDINs
Identified Hazards
Hazards
5Presence in food products leading to detention; Management in spices; Contaminants found in spices and herbs; Physical and chemical separation of mycotoxins from agricultural products; Ingredient-related chemical hazards; toxic metabolites produced by certain fungi; Chemical hazard requiring process controls like storage and sorting.; Hazard produced by mold during storage; Toxic metabolites produced by certain fungi; chemical hazard narrowly applying to a subset of foods; Potential food-related
biological hazard in frozen ice cream novelty; Biological hazard in cheese
reasonably foreseeable hazard in corn gluten meal
Pathogens that commercial processing must adequately reduce
Chemical hazard addressed in Chapter 11; Egg, milk, soy, wheat, tree nut (almond), peanut, fish, shellfish, sesame
Related CFR Sections (4)
- 21CFR117.136§ 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
(a) Circumstances. If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:Read full regulation →
- 21CFR1.507§ 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?
(a) Circumstances. You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply:Read 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 →
- 21CFR507.36§ 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
(a) If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-30
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
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
See Also (8)
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities (Status: Final)
- Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds (Status: Final)
- Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce (Status: Draft)
- Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments (Status: Final)
- Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption (Status: Final)
- Guía para la industria: Evaluación de la inocuidad de los cultivos alimentarios para el consumo humano afectados por las inundaciones (Status: Final)