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, all of which can be viewed here. Below is a summary of the biggest changes to food safety regulation.


FSMA mandates that all food facilities implement a preventative controls plan. A preventative 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 response plan to potential food safety hazards
  • Furthermore, FSMA mandates that the FDA creates a minimum safety standards for the production of fruits and vegetables. The minimum safety standards must be science based and cover soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water.

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 preventative 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. Several upcoming courses are available.

Upcoming FSMA PCQI Training Dates in Minneapolis, MN

Next Preventive Controls for HUMAN Food Class May 2-4, 2017, Minneapolis, MN
Seats Available

View detailed PCQI Class agenda & pricing

Spanish version of the training: May 16-18.

Get Notified of New Training Dates

Interested in PCQI Training Updates? Enter your email and we will notify you when new classes are offered.


What is PCQI?

Who needs PCQI Training?

What is HARPC?

FSMA & FSSC 22000


Email us

FSSC 22000 Implementation Package

Train your project leader: How to implement FSSC 22000 from start to finish.

SQF Implementation Package

Train your project leader: How to implement SQF from start to finish.