Description
In 21 Code of Federal Regulations (CFR) part 117 (part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published the final rule establishing part 117 in the Federal Register of September 17, 2015 (80 FR 55908). Part 117 establishes requirements for current good manufacturing practice for human food (CGMPs), for hazard analysis and risk-based preventive controls for human food (PCHF), and related requirements.
Scope & Applicability
Product Classes
10Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Growth and survival of pathogens in egg products
Toxin production by Bacillus cereus in dairy products
Conclusions of an ECFF botulinum working party.
Distribution and behavior of Listeria monocytogenes in vacuum-packed lots.
Heat resistance of Listeria monocytogenes.
Fresh and Dried herbs
Dried, Ground, Cracked, or Whole spices
Potential chemical hazards in ambient storage
Chemical hazards in refined oils during food production
Stakeholders
10Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control
Subject Matter Experts who recommended hazards for identification; Subject Matter Experts who recommended hazards be identified; Subject Matter Experts who identified potential hazards; Subject Matter Experts identifying potential biological hazards
Recipients of food being recalled
Entity engaged in processing acidified foods
Person who establishes the scheduled process
exempt from certain preventive controls requirements, e.g., very small business
individual performing audits for a certification body
Entity responsible for submitting NDINs
Entity in the supply chain between the receiving facility and the supplier
Conducts audits of the supplier in accordance with subpart G; Individual conducting audits in accordance with regulations
Regulatory Context
Attributes
10Level of unavoidable defect at which FDA may regard food as adulterated.
critical process parameter for inactivation kinetics
Relative lethality of 1 minute at a designated temperature
Increase in temperature that results in a 90 percent reduction in the D-value
Time required to destroy 90 percent of the vegetative cells or spores at a given temperature
Condition under which certain biological hazards apply to spices
acidified vegetable products
LACF products
Characteristic of extra hard cheese
Storage condition for ice cream and frozen novelty items; Storage condition for frozen novelties and condensed soups
Identified Hazards
Hazards
10Biological hazard requiring process control validation; Validation of a process control for a bacterial pathogen in Chapter 9
Effect of sodium nitrite on growth of Shigella flexneri
Low temperature induced non-culturability and killing
Ecology in Chesapeake Bay and survival in fish homogenate
Death in real mayonnaise and reduced-calorie mayonnaise dressing
Survival in foods and comparison with a predictive model.; Growth and survival characteristics in liquid egg
Modelling the effect of pH, acidulant and temperature on growth rate.; Mathematical modeling of growth, survival and death
Studies on toxin formation and stability in different environments.
Hazard due to incorrect label or cross-contact
The focus of Chapter 11 and the FSPCA forms.
Related CFR Sections (20)
- 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 →
- 21CFR117.305§ 117.305 General requirements applying to records.
Records must:Read full regulation →
- 21CFR184.1259§ 184.1259 Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-oleoyl-3-stearin is “cocoa butter substitute primarily from palm oil.” The common or usual name for the triglyceride 1-3-distearoyl-2-olein is “cocoa butter substitute primarily from high-oleic safflower or sunflower oil.”Read full regulation →
- 21CFR172.861§ 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.
The food additive, cocoa butter substitute from coconut oil, palm kernel oil, or both oils, may be safely used in food in accordance with the following conditions:Read full regulation →
- 21CFR165.110§ 165.110 Bottled water.
(a) Identity —Read full regulation →
- 21CFR81.10§ 81.10 Termination of provisional listings of color additives.
(a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain β-naphthylamine as an impurity. While it has been asserted that the two colors can be produced without the impurity named, no method of analysis has been suggested to establish the fact. β-Read full regulation →
- 21CFR106.55§ 106.55 Controls to prevent adulteration from microorganisms.
(a) A manufacturer of infant formula shall establish a system of process controls covering all stages of processing that is designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.Read full regulation →
- 21CFR117.10§ 117.10 Personnel.
The management of the establishment must take reasonable measures and precautions to ensure the following:Read full regulation →
- 21CFR117.130§ 117.130 Hazard analysis.
(a) Requirement for a hazard analysis.Read full regulation →
- 21CFR114.80§ 114.80 Processes and controls.
(a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.Read full regulation →
- 21CFR108.25§ 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate Read full regulation →
- 21CFR1.345§ 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
(a) If you are a nontransporter, you must establish and maintain the following records for food you release:Read full regulation →
- 21CFR114.100§ 114.100 Records.
(a) Records shall be maintained of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and Drug Administration regulations and guidance documents or action levels.Read full regulation →
- 21CFR117.475§ 117.475 Records documenting the supply-chain program.
(a) The records documenting the supply-chain program are subject to the requirements of subpart F of this part .Read full regulation →
- 21CFR117.9§ 117.9 Records required for this subpart.
(a) Records that document training required by § 117.4(b)(2) must be established and maintained.Read full regulation →
- 21CFR114.89§ 114.89 Deviations from scheduled processes.
Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a compRead full regulation →
- 21CFR117.201§ 117.201 Modified requirements that apply to a qualified facility.
(a) Attestations to be submitted. A qualified facility must submit the following attestations to FDA:Read full regulation →
- 21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
- 21CFR117.310§ 117.310 Additional requirements applying to the food safety plan.
The owner, operator, or agent in charge of the facility must sign and date the food safety plan:Read full regulation →
- 21CFR120.24§ 120.24 Process controls.
(a) In order to meet the requirements of subpart A of this part , processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( i.e., 10 5 ) reduction, for a period at least as lonRead full regulation →
Related Warning Letters (10)
- 2025-12-16
Processing & Bottling of Bottled Drinking Water Regulations/Adulterated
Longford Water Company LLC
- 2025-12-16
PHS Act/Shell Egg Regulation/Adulterated
North Creek Farm
- 2025-11-25
PHS Act/Shell Egg Regulation/Adulterated
Robert G. Miller dba Granja Asomante
- 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/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, 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
- 2025-09-30
PHS Act/Shell Egg Regulation/Adulterated
Nestor Reyes Farm & Associates
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)