Frequently Asked Questions

Who needs a HARPC plan?
Unless exempted by law, every food facility, both in the United States and abroad, that is subject to FDA’s Bioterrorism Facility Establishment registration, must establish and implement an adequate HARPC plan. The owner, operator or agent in charge of the facility must have their HARPC plan available and ready to present to FDA after receiving an oral or written request. The plan must be correct, or the firm could find itself the target of a public FDA Letter or Import Alert.

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. 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.  Under a consent decree, FDA is required to issue these regulations by August 30, 2015.

Under the proposed rule, FDA indicated that HARPC would become effective 60 days after publication. However, FDA would not require a business to comply until 12 months to 36 months after publication of the final rule. The compliance date depends on a business’s size. These are only the proposed compliance dates and FDA may extend them if additional time is needed.

Who is responsible for the HARPC plan?
The owner, operator, or agent in charge of a domestic or international food facility is required to develop an adequate HARPC plan for any facility that is subject to FDA food facility registration under The Bioterrorism Act. There are no substantive adulteration charges that apply to food manufactured in a facility that fails to comply with HARPC. Rather, failure to implement HARPC is defined by the FSMA as a “prohibited act”. Therefore, failure to comply will lead to criminal prosecution of the company (corporation, partnership, association, etc.) and / or the owner, operator or agent in charge of the facility.

How are HARPC and HACCP similar/different?
HACCP (Hazard Analysis and Critical Control Point) is the FDA’s regulatory predecessor to FSMA’s statutory HARPC.  HACCP is a very similar hazard control system, but only applies to seafood and juice processors.  HARPC applies to all food facilities subject to FDA registration except those covered by and in compliance with HACCP (and a few other significant exemptions discussed below). Another significant difference is that seafood and juice HACCP were created by FDA regulation – not by federal statute. HARPC was created by an amendment to the Food Drug and Cosmetic Act, specifically, the Food Safety Modernization Act (FSMA). Although arguments could be made that seafood and juice HACCP are unconstitutional, in that they were created by a federal agency and not by the federal legislative process, those arguments do not exist for HARPC.

Which facilities?
Any food facility in the United States or abroad that is producing food products for distribution in the United States and that is subject to FDA’s Food Establishment Registration regulations (created by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002).  There are some substantive exemptions, however, see below.

 Is anyone exempt from HARPC?
There are 6 major categories of food facilities that are exempt from HARPC. The first major exemption relates to food companies under the exclusive jurisdiction of the U.S. Department of Agriculture (those handling, processing, shipping meat, poultry, pork, eggs, etc.). The second major exemption is for companies that are subject to FDA’s new Standards for Produce Safety authorities, which were also created by FSMA. This exemption applies to farms, cooperatives, growers, harvesters and other companies handling raw fresh fruits and vegetables. The third major exemption applies to facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations.  The fourth, more limited exemption, involves low acid and acidifed canned food processors, but only as the regulatory controls govern and control certain aspects of microbiological contamination (e.g., botulism). The fifth group of exempt companies includes those defined as “small” or “very small” businesses. FDA is required to define these terms by regulation.  Sixth and last, and very similar to the immediately previous exemption, is the group of companies with a previous 3-year average product value of less than $500,000.  FDA may also, by future regulations, exempt facilities that solely produce food for animals, store raw agricultural commodities (other than fruits and vegetables) intended for further processing or that store packaged foods that are not exposed to the environment.

How often do I have to submit or update my HARPC plan?
FDA requires that a facility update its HARPC plan every 3 years or whenever there is a significant change at that facility which may increase a potential hazard or introduce a new one. Additionally, FDA may require an update based on new hazards related to biological, chemical, radiological or terrorist threats.  There is no statutory requirement to submit your HARPC plan to FDA at any particular time, except, when FDA orally (or in writing) requests you to provide a copy of your HARPC plan and any and all records necessary to demonstrate that you have properly implemented it.

What if I don’t create a HARPC plan? (Or my plan is inadequate?)
If a facility does not create a HARPC plan or if FDA determines a HARPC plan is inadequate FDA can take a number enforcement steps. First, FDA can criminally charge a company or person for owning, operating or acting as agent in charge of a facility not in compliance with HARPC. Second, FDA can issue a public warning letter and / or (for foreign firms) an Import Alert.

If food from a non-compliant facility presents a significant food safety risk, FDA could suspend the facility’s food facility registration and thereby prevent the facility from distributing product until FDA has approved a corrective action plan.

In the case of a foreign firm, FDA would likely place the facility on an Import Alert (similar to Import Alert 16-120). A firm that is listed on this Import Alert would find its food automatically detained at importation, effectively barring it from the United States market unless FDA reviews and accepts an adequate HARPC plan.