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Food Safety Modernization Act

What is the Food Safety Modernization Act?

The Food Safety Modernization Act of 2011 (FSMA) is the most fundamental change to food safety regulations in over 70 years. Affecting every step of the supply chain, FSMA gives the FDA the power to prevent rather than react to food safety crises.


What does FSMA do?

The Food Safety Modernization Act is 89 pages of dense litigation. Below is a summary of the biggest changes to food safety regulation.


FSMA mandates that all food facilities implement a preventive controls plan. A preventive control plan includes:

  • An evaluation of potential food safety hazards
  • Steps and controls to prevent those hazards
  • A system to monitor the controls
  • Routine records of the monitoring
  • A recall plan

Inspection and Compliance

FSMA expands the scope of the FDA’s oversight by increasing the frequency of inspections of food facilities, particularly those that are deemed to be high risk. FSMA also allows the FDA access to the records and food safety plans that are now required of all food facilities.


The FDA is now able to issue a mandatory recall of unsafe food as well as suspend the registration of a facility if they believe the food possesses a health risk. Additionally, FSMA loosens the standards required to detain products that may be in violation of the law.


FSMA holds importers accountable for their foreign suppliers. Importers must be able to verify to the FDA that their foreign supplier has an adequate preventive controls pan in place. For high risk imported foods, the FDA can demand a third party certification that assures compliance with US safety standards. However, the FDA is required to establish a program through which foreign food facilities can be verified by qualified third parties. The FDA must also establish a voluntary program that allows food importers to go through an expedited review if their food is sourced from certified facilities.

Enhanced Partnerships

Lastly, FSMA aims to improve food safety through collaboration with both foreign and domestic government agencies. FSMA provides the FDA with a multi-year grant to strengthen the food safety capabilities of state and local agencies whom the FDA will rely on to meet its increased inspection mandate. FSMA also directs the FDA to develop a plan to address educating foreign governments and food producers on US safety standards.

The regulation requires that certain activities be performed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls.

What is a PCQI?

A Preventive controls qualified individual “means a qualified individual 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.” This is the definition is from Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation § 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation § 507.3.

Responsibilities of a PCQI

Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food.

PCQI Requirements

One way to become a PCQI, is to take the Preventive Controls for Human Food Course. This course, taught by a Preventive Controls for Human Foods Lead Instructor was developed by FSPCA in collaboration with the FDA. You will then receive your training certificate which is issued by the Association of Food and Drug Officials (AFDO).

PCQI Training Courses

Cynthia Weber is a Preventive Controls Lead Instructor authorized to teach that standardized course, and is offering the 2.5 day Preventive Controls for Human Food Course in Minneapolis, MN. View upcoming courses.

FSVP Foreign Supplier Verification Program Training

Online Introduction to FSVP

Learn to comply with FSMA's Foreign Supplier Verification Program

Details & Registration

New! Employee Training

food safety employee training

Meet FSMA training requirements for training employees. Online courses available for GMP, HACCP, Allergen Management & Food Defense

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FSMA & FSSC 22000