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The New FDA Food Safety Modernization Act (FSMA)

Hazard Analysis and Risk-Based Preventive Controls (HARPC)

Sec. 103 of the Food Safety Modernization Act describes HARPC in the following way:

“The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

When are HARPC plans required?

Under the statute, FSMA HARPC took legal effect on July 4, 2012, even though FDA did not issue required guidance documents or regulations at that time. However, FDA is exercising enforcement discretion until it issues a final regulation implementing the requirement. The HARPC provision also requires FDA to define “small” and “very small” businesses for the purposes of determining the scope of one of the HARPC exemptions. TJH Consulting, LLC expects FDA to issue these regulations in final form sometime in 2013.

What is HARPC?

HARPC stands for “Hazard Analysis and Risk-Based Preventive Controls.” It is one of many new provisions of the FDA Food Safety Modernization Act, a sweeping food safety legislation amending the Food, Drug and Cosmetic Act that was enacted in January of 2011. HARPC requires virtually every food manufacturer, packer, bottler and storage facility to identify food safety and adulteration risks associated with their foods and processes, to implement controls to minimize the risks, to verify that the controls are working, and to design and implement corrective actions to address any deviations from the controls that might arise. Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions surrounding facilities, controls, hazards, and the adulteration of foods. HARPC requires each food facility to document all aspects of its plan, periodically review it, constantly maintain it, and document its verification steps.

HARPC Requirements

1. Identify Hazards
2. Risk-based Preventive Controls
3. Monitoring of Effectiveness
4. Corrective Actions
5. Verification
6. Recordkeeping and Documentation
7. Requirement to Reanalyze

Get a HARPC plan

Are you ready to create your HARPC plan? Simply gather the following information and contact us to get started:

• Facility contact and registration information
• List of products developed at facility
• Key contact at your organization to work with

Are you in the process of creating a HARPC plan? Have you started but hit a roadblock or unexpected challenge? Have you discovered information about your food or food processing that could lead to a risk of litigation? Or do you just need a partner to walk through and review the process with you?

The team at TJH Consulting, LLC represents and assists companies of all sizes domestically and internationally with all aspects of FDA compliance, including HARPC or HACCP plan development.

If you need assistance developing your HACCP or HARPC Plan please contact:

Thomas J. Hoffman, President
TJH Consulting, LLC
617 Woodsmans Way
Crownsville, MD  21032
Phone: (410) 266-3332
Fax: (410) 573-1784
Cell: (410) 693-2815