Description
This guidance is intended for those persons (“you”) who are subject to our regulation, in 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” and who manufacture, process, pack, or hold fresh-cut produce. In this guidance, “fresh-cut produce” means any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). Fresh-cut produce may or may not undergo a wash or other treatment before being packaged for use by the consumer or a retail food establishment. Fresh-cut produce can be a single commodity or two or more mixed in the same package, such as coleslaw or fruit salads, and sometimes called “ready to use,” “pre-cut,” or “value added” produce. Fresh-cut produce also does not include produce that has been processed by freezing, cooking, canning, or packing in a juice, syrup, or dressing.
Scope & Applicability
Product Classes
8Guide to Minimize Food Safety Hazards of Fresh-cut Produce; Fresh fruit or vegetable physically altered from its whole state; subject of the guidance document; The primary product category addressed by the guidance; minimizing food safety hazards during manufacturing and distribution; subject of the hazard analysis and preventive controls; must include an evaluation of environmental pathogens; Subject of the guidance document; Guidance for minimizing food safety hazards in fresh-cut produce.
Sprouts in their raw or natural state
Food normally eaten in its raw state without further processing
minimizing cross-contamination of fresh-cut leafy vegetables with biological hazards; Specific product category for the process control example
Ready-to-eat foods containing pathogens
Ready-to-eat food exposed to environment
Foods that consumers eat without cooking; fresh-cut produce is typically considered ready-to-eat; RTE foods that do not require further processing for safety
RACs such as hops, wine grapes, pulse crops, and almonds
Stakeholders
10Employees handling RTE foods or cleaning equipment
Person identified to perform FSVP activities on the importer's behalf; person performing FSVP activities; person with education, training, or experience to perform FSVP activities; Person with education, training, or experience to perform FSVP activities; Person required to conduct or oversee hazard analysis; Person with education, training, or experience to perform FSVP activities.; person required to conduct and document verification activities; person with expertise to review and assess verif
May inspect food storage tanks for both food safety and food defense purposes.
Preventive Controls Qualified Individual involved in corrections
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Manufacturer/processor covered by preventive controls requirements; Manufacturer/processor receiving ingredients from a supplier
Person responsible for monitoring or following corrective action instructions
Person responsible for maintaining grounds and plant
responsible for monitoring employee health
role responsible for evaluating food safety before release; PCQI role in food safety
Regulatory Context
Attributes
6infected individuals showing no symptoms
dissolved and suspended solids that consume free chlorine; continually increases as product is fed into the system
TCS food requiring specific conditions to limit pathogen growth; TCS food requirements to limit pathogen growth
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Lack of change to water activity
Required quality of water in fresh-cut processing
Identified Hazards
Hazards
10Outbreaks of Foodborne Illness Associated with Fresh-cut Produce
Quantitative and predictive food microbiology; Topic of resources provided by FDA and USDA/ARS
Pathogen capable of surviving in the manufacturing environment
Facilities designed to prevent cross-contamination
Known or reasonably foreseeable hazards requiring preventive control; Types of hazards analyzed in the food safety plan.; Pathogens or biological agents that can cause illness; Pathogens and microbial forms in animal food
hazards requiring sanitation controls in RTE facilities
risk in multidose drug products
Risk factor in platelet storage; Risk controlled by cold storage; control the risk of bacterial contamination for up to 14 days
Risk associated with porous materials or deteriorated surfaces
chemical hazard under 21 CFR 117.130(b)(1)(ii)
Related CFR Sections (20)
- 21CFR117.165§ 117.165 Verification of implementation and effectiveness.
(a) Verification activities. You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards. To do so you must conduct activities that include the following, as appropriate to the facility, the food, and the natureRead full regulation →
- 21CFR117.180§ 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
(a) One or more preventive controls qualified individuals must do or oversee the following:Read full regulation →
- 21CFR117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
(a) Applicability.Read full regulation →
- 21CFR117.305§ 117.305 General requirements applying to records.
Records must:Read full regulation →
- 21CFR117.150§ 117.150 Corrective actions and corrections.
(a) Corrective action procedures. As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by paragraph (c) of this section:Read full regulation →
- 21CFR117.160§ 117.160 Validation.
(a) You must validate that the preventive controls identified and implemented in accordance with § 117.135 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system.Read full regulation →
- 21CFR173.300§ 173.300 Chlorine dioxide.
Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in food in accordance with the following prescribed conditions:Read full regulation →
- 21CFR173.325§ 173.325 Acidified sodium chlorite solutions.
Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions:Read full regulation →
- 21CFR173.315§ 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables.
Chemicals may be safely used to wash or to assist in the peeling of fruits and vegetables in accordance with the following conditions:Read full regulation →
- 21CFR117.430§ 117.430 Conducting supplier verification activities for raw materials and other ingredients.
(a) Except as provided by paragraph (c) , (d) , or (e) of this section, one or more of the supplier verification activities specified in § 117.410(b) , as determined under § 117.410(d) , must be conducted for each supplier before using the raw material or other ingredient from that supplier and periRead 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 →
- 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 →
- 21CFR117.405§ 117.405 Requirement to establish and implement a supply-chain program.
- 21CFR117.155§ 117.155 Verification.
(a) Verification activities. Verification activities must include, as appropriate to the nature of the preventive control and its role in the facility's food safety system:Read full regulation →
- 21CFR117.145§ 117.145 Monitoring.
As appropriate to the nature of the preventive control and its role in the facility's food safety system:Read full regulation →
- 21CFR117.130§ 117.130 Hazard analysis.
(a) Requirement for a hazard analysis.Read full regulation →
- 21CFR117.170§ 117.170 Reanalysis.
(a) You must conduct a reanalysis of the food safety plan as a whole at least once every 3 years;Read full regulation →
- 21CFR117.80§ 117.80 Processes and controls.
(a) General.Read full regulation →
- 21CFR117.37§ 117.37 Sanitary facilities and controls.
Each plant must be equipped with adequate sanitary facilities and accommodations including:Read full regulation →
- 21CFR117.126§ 117.126 Food safety plan.
(a) Requirement for a food safety plan.Read full regulation →
Related Warning Letters (10)
- 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
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
See Also (8)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Status: Final)
- CPG Sec 100.250 Food Facility Registration (Human and Animal Food) (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)