Description
The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) rule creates new requirements for the production of human food by registered food facilities, and revises previous requirements. This guide was developed to inform domestic and foreign food facilities about thePCHF regulationand how to comply with it. It contains important information that may affect your firm.
Scope & Applicability
Product Classes
9Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Packaged food not exposed to the environment
Food that is in a form that is edible without additional preparation to achieve food safety
Type of food eligible for import under VQIP
By-products sent for use as animal food
Food requiring hazard analysis and scheduled process
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
A dietary supplement is deemed to be food under section 201(ff)
specific requirements under 21 CFR 1.502(b); thermally processed food in hermetically sealed containers
Stakeholders
10Target audience for the compliance guide
Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Qualified individual with technical expertise to perform auditing functions; person defined in 21 CFR 1.500 who performs audits; person conducting onsite audits without financial conflicts; Person required to conduct onsite audits
Entity responsible for submitting NDINs
Assigned responsibility for overall sanitation of the plant
Employees handling RTE foods or cleaning equipment
Involved in the effective system for managing quality
A business averaging less than $1,000,000 in annual sales of human food; Definition based on average annual sales plus market value; Business averaging less than $2,500,000 in annual sales of animal food
Target audience for the compliance guide
Regulatory Context
Attributes
9November 20, 2024
Moisture level low enough to prevent microorganism growth
Metric used to determine small business status based on 2,080 hours per year
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
Factor affecting pathogen growth
Specification for acid fruits and vegetables used in jams
Acidity level defining low-risk fruit and vegetable processing
TCS food requiring specific conditions to limit pathogen growth; TCS food requirements to limit pathogen growth
Business averaging less than $1,000,000 in annual food sales.
Identified Hazards
Hazards
10Includes microbiological hazards like parasites and pathogens; Hazards associated with covered produce requiring controls.; Risks such as foodborne illness outbreaks.
Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
Microorganisms that safe moisture levels and sanitization aim to prevent
Objectionable animals or insects including birds, rodents, flies, and larvae
Adulteration link that triggers DWPE.
Possibility of introducing an allergen through transferring genetic material.
A pathogen capable of surviving and persisting with the manufacturing processing environment
reasonably foreseeable hazard in corn gluten meal
chemical hazard under 21 CFR 117.130(b)(1)(ii)
Includes rodents and birds that can contaminate equipment and produce.; Attracted by trash, litter, and waste.
Related CFR Sections (18)
- 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 →
- 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 →
- 21CFR117.95§ 117.95 Holding and distribution of human food by-products for use as animal food.
(a) Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor, as identified in § 507.12 of this chapter , must be held under conditions that will protect against contamination, including the following: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 →
- 21CFR117.251§ 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption.
(a) FDA may withdraw a qualified facility exemption under § 117.5(a) :Read 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 →
- 21CFR117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
(a) Applicability.Read full regulation →
- 21CFR117.410§ 117.410 General requirements applicable to a supply-chain program.
(a) The supply-chain program must include:Read full regulation →
- 21CFR117.405§ 117.405 Requirement to establish and implement a supply-chain program.
- 21CFR117.10§ 117.10 Personnel.
The management of the establishment must take reasonable measures and precautions to ensure the following: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 →
- 21CFR117.35§ 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 →
- 21CFR117.37§ 117.37 Sanitary facilities and controls.
Each plant must be equipped with adequate sanitary facilities and accommodations including:Read full regulation →
- 21CFR117.40§ 117.40 Equipment and utensils.
- 21CFR117.80§ 117.80 Processes and controls.
(a) General.Read full regulation →
- 21CFR117.93§ 117.93 Warehousing and distribution.
Storage and transportation of food must be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of food, as well as against deterioration of the food and the container.Read full regulation →
- 21CFR117.110§ 117.110 Defect action levels.
(a) The manufacturer, processor, packer, and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.Read full regulation →
- 21CFR117.126§ 117.126 Food safety plan.
(a) Requirement for a food safety plan.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
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/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Vidaslim Co.
- 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
- 2025-09-16
Unapproved New Drugs/Misbranded
Mericon Industries, Inc.
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- CVM GFI #239 Human Food By-Products For Use As Animal Food (Status: Draft)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Status: Draft)
- CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) (Status: Final)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)
- Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)
- Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food (Status: Final)