Complying with the PCHF Rule
Tools for determining requirements under the Preventive Controls for Human Food (PCHF) rule and resources on how to comply with basic requirements.
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A quick questions and answers sheet that explains the basic components of the preventive controls rule and who needs to comply with them.
Title 21: Chapter I: Subchapter B: Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
This is the full text of the federal regulations regarding good manufacturing practice, hazard analysis, and risk-based preventive controls for human food.
Am I affected by the new Food Safety Rules under the Food Safety Modernization Act?: A Flowchart for Farmers and Food Businesses
A flowchart that explains who is covered by the PC and Produce Rule and what that coverage entails
A step-by-step guide for facilities to register with the FDA, as required by FSMA
An overview of the major components of the Food Safety Modernization Act, including sections on Preventive Controls for Human Food and Food Safety plans in a questions and answers style format.
This question and answer sheet explains some of the definitions and activities that require a facility to register with the FDA.
A description of the FSMA Final rule for Preventive Controls for Human food, key requirements, assistance for industry, meetings and webinars, related guidance, supporting material, and contact information
The FSPCA training curriculum to guide processors though the PC rule. Topics covered include biological, chemical, physical, and economically motivated hazards, verification and validation procedures, record keeping procedures, process preventive controls, resources for food safety plans, sanitation preventive controls, supply chain preventive controls, recall plans, worksheets, templates, and examples.
Good Food Safety Practices: Managing Risks to Reduce or Avoid Legal Liability. Food Safety and Technology
An overview of the legal implications of foodborne illness and strategies to limit liability
Guidance for Industry: Determining the Number of Employees for Purposes of the "Small Business" Definition in Parts 117 and 507
A guidance publication to help processors determine the number of full time employees or equivalent for the purposes of being classified as a small business under FSMA
An extensive questions and answers sheet for food facilities to understand who, when, and how to register with the FDA as part of the Food Safety Modernization Act.
An interactive guide for users to answer questions that will help them understand if they must register with the FDA and how to categorize their food operations.
A Q&A sheet regarding who is covered by the PCHF rule and what that entails
Understanding the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
A document explaining some of the new regulations introduced in 21 CFR 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food), useful definitions, summaries of the different subparts, and includes examples of which subparts may apply to different foods.
A brief explainer for the forms and relevant regulation for low-acid canned food (LACF) producers seeking to comply with the preventive controls for human foods rule. This explainer includes instructions for electronic submission of registration forms.
A question and answer sheet that clarifies the differences between a retail food establishment and a farm mixed-type facility, which FSMA rules apply, and some exceptions to the rule.
This questions and answers sheet explains the differences between a primary production farm, secondary activities farm, and a mixed-type facility and which of these businesses is covered by the preventive controls rule.
A list explaining the conditions that must be met for farms of a certain size that perform certain actions to not need to follow the HARPC or SCP (supply chain program) portions of the preventive controls rule.
A brief FAQ sheet for Qualified Exempt Facilities explaining what steps facilities must take to be federally compliant, and which FSMA rules do not apply.
A guide that explains what constitutes a qualified facility and how this impacts the Preventive Controls for Human Food Rule.
A guidance publication that explains the specific regulation for juice producers, as well as exemptions and information on complying with HACCP policies.
A brief write up that explains what a facility must do to be considered a qualified facility, with links to additional guidance, forms, and instructions
A guide for seafood processors on complying with FSMA, including which parts of the PCHF rule that they may be subject to.
Guidance for Industry: What You Need To Know About Establishment, Maintenance, and Availability of Records Small Entity Compliance Guide
A guidance publication explaining which records producers are required to maintain, how long they must be held, which records are exempt, who must keep records, and how the FDA will go about requesting records.
Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
A guide designed to provide small entity processors with the most essential aspects of FSMA's Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule.