Preventive Controls for Human Food (PCHF) Rule and Key Requirements:

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (referred to as the Preventive Controls for Human Food regulation) requires facilities that manufacture, process, pack or hold human food to conduct a hazard analysis and implement risk-based preventive controls for identified hazards. In general the rule applies to facilities that have to register with FDA under section 415 of the Food Drug and Cosmetic Act. Both domestic and facilities and those exporting food for consumption in the US must comply with the rule. Each facility would be required to implement a written food safety plan that focuses on preventing hazards identified in the food. The foodsafety plan is required to:

  • Identify known or reasonably foreseeable hazards that may be present in the food handled at that facility (including biological, chemical including radiological and physical hazards),
  • Implement preventive controls for hazards that require such a control to significantly minimize or prevent them,
  • Develop effective monitoring procedures for the controls,
  • Establish written corrective action and correction procedures if preventive controls are not properly implemented or found to be ineffective,
  • Validate preventive controls and conduct verification activities including verficiation ofmonitoring and corrective actions,
  • Re-analyze the food safety plan at least once every three years or sooner if significantchanges are made

  • How can companies comply with PCHF rule?

    PCHF is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the US.The preventive control requirements go beyond the traditional HACCP. The regulation requires that certain activities must be completed by a “preventive controls qualified individual (PCQI)” who has “successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system”. The Food Safety Preventive Controls Alliance (FSPCA), a broad-based public private alliance, has developed a “standardized curriculum” recognized by FDA for the training course. This course is taught by FSPCA Lead Instructors. Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual”. The Association of Food and Drug Officials (AFDO) and the International Food Protection Training Institute (IFPTI) administer certificates for all participants that successfully complete the FSPCA Preventive Controls for Human Food course.

    FSPCA Preventive Controls for Human Food Course:

    This course developed by FSPCA is the “standardized curriculum” recognized by FDA. Successfully completing this course is one wayan individual to meet the requirements for a “preventive controls qualified individual (PCQI).” Under the Preventive Controls for Human Food (PCHF) regulation, the responsibilities of a PCQI include to perform and/or oversee 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review and 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food.

    This course will be conducted with the following learning objectives:
  • Successfully completing this course is one way to meet the requirments for a Preventive Controls Qualified Individual.The training will provide learning opportunites on how to developa Food Safety Plan to comply with the FDA’s PCHF regulation requirements
  • Provide learning opportunities for understanding the the new PCHF requirements for implementing and documenting Preventive Controls under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule

  • Course-Agenda

    Day 1
  • Chapter 1: Introduction to Course and Preventive Controls
  • Chapter 2: Food Safety Plan Overview
  • Chapter 3: Good Manufacturing Practices and Other Prerequisite Programs
  • Chapter 4: Biological Food Safety Hazards
  • Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards
  • Day 2
  • Chapter 6: Preliminary Steps in Developing a Food Safety Plan
  • Chapter 7: Resources for Food Safety Plans
  • Chapter 8: Hazard Analysis and Preventive Controls Determination
  • Chapter 9: Process Preventive Controls
  • Chapter 10: Food Allergen Preventive Controls
  • Chapter 11: Sanitation Preventive Controls
  • Chapter 12: Supply‐chain Preventive Controls
  • Day 3
  • Chapter 13: Verification and Validation Procedures
  • Chapter 14: Record-keeping Procedures
  • Chapter 15: Recall Plan
  • Chapter 16: Regulation Overview - cGMP, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food

  • Faculty

    1. Dr. Satyanarayana KV

      Dr. Satyanarayana KV is a Lead Instructor for FSPCA Preventive Controls for Human Foods and has conducted several courses to help the food exporters to USA in meeting compliance requirements under PCHF rule. Satya is also a qualified FSSC 22000 Auditor. He has over 11 years of industry experience in research, innovation management and techno-commercial activities in agriculture and food industry domain. He is actively involved in mapping technology trends, technology scouting and advising clients on regulatory requirements for new product/ ingredient approval by food safety authority.
      Prior to joining Sathguru, Satya worked with Tata Chemicals Ltd - Innovation Centre in the areas of industrial biotechnology and food ingredients. Satya holds a Ph.D in Biotechnology from CFTRI/ University of Mysore.

    Faculty Says

    Dr. Kim Koch Faculty, FSPCA

    This program is based on the Food Safety Preventive Controls Alliance’s training curriculum for Preventive Controls for Human Food (PCHF). This curriculum is recognized by the U.S. Food and Drug Administration as one way an individual can receive a certificate indicating he/she has attended the training and is recognized as being a Preventive Controls Qualified Individual (PCQI), one requirement of all food manufacturers/processors to be compliant with the Food Safety Modernization Act (FSMA).
    It is absolutely imperative that any food manufacturer, processor, or packer that expects to continue to be able to export to the U.S. is in full compliance with FSMA; this includes the presence of a Preventive Controls Qualified Individual (PCQI) to write and oversee the implementation of the Food Safety Plan. Without complete compliance the business will not be able to export to the U.S.
    The program covers all requirements set forth in the FSMA legislation that must be fulfilled for a food production facility to be in compliance with FSMA.

    Dr. Satyanarayana K.V Faculty, FSPCA

    This training course is based on the curriculum developed by FSPCA which is the only “standardized curriculum” recognized by FDA as of now. Successfully completing this course is one way an individual can meet the requirements for a “Preventive Controls Qualified Individual (PCQI).” All exporters of food to USA (subject to exemptions) need to comply with FSMA. Some of the requirements include food safety plan written, and overseeing its implementation by a PCQI. The PCHF course curriculum covers all the requirements under FSMA that must be fulfilled by a human food manufacturing facility, and the course includes group exercises for preparing a facility’s food safety plan.
    Attending the FSPCA course would be more beneficial than reading and applying the regulations on own, even if one is familiar with HACCP. Those familiar with/ implementing GFSI recognized voluntary standards will get to know the differences in requirements under FSMA.

    Supported by Cornell-Sathguru Foundation for Development (CSFD)