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 ready-to-eat (RTE) foods. This guidance is intended for you regardless of whether you are only subject to the current good manufacturing practice requirements for human food of part 117 (CGMP requirements), the requirements for hazard analysis andrisk-based preventive controls for human foodin part 117 (PCHF), or both the CGMP requirements and the PCHF requirements. See section II.A of this guidance for additional information about the CGMP and PCHF requirements. This guidance is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
Scope & Applicability
Product Classes
2The category of food products covered by this guidance; Guidance for industry on the control of Listeria monocytogenes in RTE foods; foods that can be contaminated with L. monocytogenes; Guidance focuses on controlling Listeria in RTE foods.; Guidance for control of Listeria monocytogenes in these products; Foods requiring protection from contamination; target food category for the guidance; Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods; Guidance focuses on
Implementing targeted good manufacturing practices
Stakeholders
10Entities providing raw materials and ingredients
Required qualification for persons conducting laboratory analysis
Employees handling RTE foods or cleaning equipment
A qualified individual who has successfully completed training
personnel who must receive training on Listeria control
Consult food safety experts familiar with troubleshooting L. monocytogenes contamination.
Consultant for mitigation efforts
Preventive Controls Qualified Individual involved in corrections
role responsible for evaluating food safety before release; PCQI role in food safety
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Regulatory Context
Attributes
10Intrinsic characteristic to prevent growth of L. monocytogenes
Required state for shipping samples
Recommended for Raw Area to prevent cross-contamination
Designation reflecting proximity to RTE food and risk of contamination
Seriousness of the effects of a hazard
surfaces that contact human food
surfaces in the plant that do not directly contact food
surfaces where food is exposed and may become contaminated
Methods that provide a level of confidence such as a 95% confidence of detecting L. monocytogenes.
Food contact surfaces
Identified Hazards
Hazards
10Includes microbiological hazards like parasites and pathogens; Hazards associated with covered produce requiring controls.; Risks such as foodborne illness outbreaks.
Persistence of Listeria in food processing environments
chemical hazard under 21 CFR 117.130(b)(1)(ii)
A pathogen capable of surviving and persisting with the manufacturing processing environment
areas where Listeria can persist and multiply in a plant
ICMSF ranks L. monocytogenes as a severe hazard in foods for restricted populations.
ICMSF ranks L. monocytogenes as a serious hazard in foods for the general population.
Potential formation during washing that could contaminate food
Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
risk to be avoided through physical barriers and sanitation
Related CFR Sections (16)
- 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 →
- 21CFR117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
(a) Applicability.Read full regulation →
- 21CFR117.80§ 117.80 Processes and controls.
(a) General.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 →
- 21CFR131.3§ 131.3 Definitions.
(a) Cream means the liquid milk product high in fat separated from milk, which may have been adjusted by adding thereto: Milk, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Cream contains not less than 18 percent milkfat.Read full regulation →
- 21CFR117.135§ 117.135 Preventive controls.
- 21CFR117.405§ 117.405 Requirement to establish and implement a supply-chain program.
- 21CFR117.190§ 117.190 Implementation records required for this subpart.
(a) You must establish and maintain the following records documenting implementation of the food safety plan: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 →
- 21CFR117.35§ 117.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a mannerRead full regulation →
- 21CFR117.40§ 117.40 Equipment and utensils.
- 21CFR117.37§ 117.37 Sanitary facilities and controls.
Each plant must be equipped with adequate sanitary facilities and accommodations including:Read full regulation →
- 21CFR117.20§ 117.20 Plant and grounds.
(a) Grounds. The grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds must include: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 →
- 21CFR117.3§ 117.3 Definitions.
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 →
- 21CFR117.130§ 117.130 Hazard analysis.
(a) Requirement for a hazard analysis.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 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.
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
- 2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)