Frequently Asked Questions

Who needs a HARPC food safety plan?
Unless expressly exempted by law, virtually 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 food safety 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 food safety plans required?
Industry is required to establish a compliant HAPRC food safety plan as of September 17, 2016, which was one year after the publication of the final rule. There are several exceptions. One big consideration is the size of the business. If the business’ number of full time employee equivalent does not exceed 500, or if the yearly market value of the foods it sells have not exceeded $1 million in recent years, then the compliance date is extended until 2018. Also, if the business is only a receiving facility, it will not be required to have a HARPC food safety plan in place until its supplier’s compliance dates.

How are HARPC and HACCP similar/different?
HACCP (Hazard Analysis and Critical Control Point) is the FDA’s regulatory predecessor to HARPC under FSMA.  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 laws (legislation) created by a federal regulatory agency and not by Congress, signed by the President, those arguments do not exist for HARPC. Functionally, HACCP and HARPC are very similar, thought supplier verification procedures (including the Foreign Supplier Verification Program requirements (FSVP) are much more rigorous under FSMA.

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 facilities handling, processing, or 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 acidified canned food processors, but only for the regulatory controls that govern and control certain aspects of microbiological contamination (e.g., botulism).
• The fifth group of exempt companies includes small or very small on-farm businesses.
• Sixth, 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. Very Small Business means, for the purposes of the Human Food Preventative Control regulations, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale. That same term has an identical definition for the purposes of the Animal Food Preventative Control regulations, except the dollar threshold is higher at $2,500,000. Note: These were the baseline dollar amounts, which FDA is adjusting annually, see  FSMA Inflation Adjusted Cut Offs for up-dated values.
•  Seventh, certain dietary supplements and alcoholic beverages facilities can be exempted.
• Eighth, storage of the raw agricultural commodities.

Farm or Facility? FSMA Guidance Explained

One of the more important features of the Food Safety Modernization Act (FSMA) is that farms are exempted from Hazard Analysis and Risk-based Preventive Controls (HARPC) and from the requirement to register with the FDA as a food facility. Naturally, then, the question of whether a facility qualifies as a farm is critical.

What is a Farm?

The new regulations recognize two types of farms. A Primary Production Farm (PPF) is “an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities.” A facility may also qualify as a Secondary Activities Farm (SAF) as long as a PPF owns a majority interest in the operation and the same PPF grows, harvests, and/or raises the majority of the raw agricultural commodities (RAC) that the secondary operation handles.

According to FSMA, farming activities include packing or holding RACs and packing, holding, or even manufacturing of processed food as long as it is either consumed on that farm or on another farm under the same management. In certain instances, the manufacturing or processing of food that is not consumed on that farm is also permitted without forfeiture of the facility’s exemption from registration, but here is where it is vital for a facility to understand the distinctions.

Packing vs. Packaging

FDA provides definitions of harvesting, packing, packaging, holding, and manufacturing/processing, but the task of categorizing activities is complicated by the reality that the same activity can be both harvesting and packing, or processing in one instance but packing under a different set of circumstances. For instance, trimming harvested RACs may be considered part of harvesting if it is done in the same location as the harvesting, but it may become a manufacturing/processing activity if performed later in a food processing facility. Similarly, placing RACs into boxes to ship to distribution centers or retailers is “packing,” while “placing food into a container that directly contacts the food and that the consumer receives is “packaging.” Under FSMA, packaging is a manufacturing/processing activity, but packing is not. Though both may fall within the definition of “farm,” there are situations in which “packaging” does not fit the farm definition.
Such fine distinctions create the possibility that the same facility may engage in activities that qualify it as a farm and other activities that require it to register as a food facility. The regulation defines such an operation as a Mixed-type facility and requires that it be registered.

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 biological or chemical hazards.  There is no statutory requirement to submit your HARPC plan to FDA at any particular time, except, when FDA requests you to provide a copy of it. FDA would also request records necessary to demonstrate that you have properly implemented your HARPC plan. FDA’s request could be oral or in writing including during an FDA inspection.

What if I don’t have a HARPC plan? (Or my plan is inadequate?)
If a facility does not have 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 place foreign firms on 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 food products 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.

Helpful Guidance

The authors of the FDA Draft Guidance have labored (and largely succeeded) to provide industry with clear guidelines so that they can determine whether their operation qualifies as a farm or whether they need to register the facility with FDA. The guidance offers strategies for evaluating the various operations of a facility in order to determine whether registration is necessary, and the guidance provides numerous hypothetical scenarios that illustrate the careful distinctions mandated by the regulation.

The consequences of producing food in an unregistered facility can be steep. Collectively, FDAImports.com staff has more than a century of experience with FDA. We can help you make an informed determination of whether registration is necessary, and if that is the next step, we can handle that process expeditiously. Contact us today to discuss your situation.