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Understanding and Preparing for FSMA's HARPC Requirements

March 21, 2016
Exploring the first step in preparing a facility’s food safety plan: the hazard analysis.

This article is the second in a series exploring the requirements of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) of the FDA Food Safety Modernization Act (FSMA). The first article discussed the requirement for a written food safety plan under HARPC and its basic components, the facilities to which HARPC applies, and the facilities that are exempted in whole or in part from HARPC.

The ultimate goal of the hazard analysis under HARPC is to determine whether any preventative controls are required for the food, facility or both. Under this requirement, food facilities must prepare a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility. Accordingly, a hazard analysis has two main components: (1) hazard identification and (2) hazard evaluation.

Hazard Identification

When identifying hazards, a facility must consider all known or reasonably foreseeable hazards. A “hazard” is simply something that has the potential to cause illness or injury. A “known or reasonably foreseeable hazard” is an important concept under HARPC and it means “a biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.” Importantly, hazards can be naturally occurring, unintentionally introduced, or intentionally introduced for the purpose of economic gain.

FDA has described the hazard identification phase as a “brainstorming session” designed to develop a list of potential hazards. During this phase, facilities should consider illness data, scientific reports, its own experience and any other relevant information to determine hazards potentially related to its food or facility. Potential known or reasonably foreseeable hazards include radiological hazards, natural toxins, pesticides, drug residues, pathogens, decomposition, parasites, physical hazards (e.g., stones, glass, metal fragments), allergens, and unapproved food and color additives.

Hazard Evaluation

After hazards have been identified, each must be evaluated to determine if it requires a preventative control. The evaluation is carried out by “a person knowledgeable about the safe manufacturing, processing, packing, or holding of food.” The evaluation has two parts: (1) The severity of the illness or injury if the hazard were to occur and (2) the probability that the hazard will occur without preventive controls. Thus, a preventative control must be implemented for a reasonably foreseeable hazard if, after the hazard evaluation, “a person knowledgeable about the safe manufacturing, processing, packing, or holding of food” would establish one or more preventive controls to significantly minimize or prevent the hazard as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system.

The first step in hazard evaluation is determining the severity of the illness or injury posed by the identified hazard. This will again require facilities to consider illness data, scientific reports, its own experience and any other relevant information. The severity should include the magnitude and duration of the illness and the impact of any resulting chronic conditions. In other words, both short term and long term effects of exposure to the hazard should be considered.

As examples, FDA finds that biological hazards often lead to immediate illness or injury (e.g., gastrointestinal illness) and can lead to long-term consequences (e.g., infections with Salmonella spp. may lead to reactive arthritis). FDA also notes that the health effects related to exposure to some biological hazards are severe, such as Hemolytic Uremic Syndrome, otherwise known as HUS, in persons exposed to E. coli O157:H7 or invasive listeriosis in susceptible persons exposed to L. monocytogenes.

As further examples regarding chemical hazards, FDA finds that exposure can lead to immediate illness, such as, an allergic reaction to an undeclared peanut or to a residue in milk of penicillin used to treat the cow. However, long term effects should also be considered, such as impaired cognitive development in children exposed to lead in foods and liver cancer as the result of chronic exposure to aflatoxin. HARPC requires that hazards, such as the examples of biological and chemical hazards discussed above, be evaluated to determine whether they are reasonably likely to occur, even if the chemical hazard occurs infrequently.

HARPC also sets forth a specific requirement for the evaluation of environmental pathogens in conjunction with certain ready-to-eat (RTE) foods. Whenever a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or include a control measure that would significantly minimize the pathogen, the hazard analysis must evaluate environmental pathogens.

What constitutes RTE food is interpreted broadly and includes food for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards, e.g., raw cookie dough and dried soup mix. Examples of environmental pathogens include Salmonella spp. and L. monocytogenes. Although HARPC sets forth this specific requirement for certain RTE food, it does not exclude other foods and facilities from the potential evaluation of environmental pathogens. In other words, environmental pathogens must be included in a hazard analysis if they are known or reasonably foreseeable hazards, regardless of the RTE-status of the food.

In addition, the hazard evaluation must consider virtually every aspect of the food evaluated – including its ingredients and formula; production facility and equipment; processing; transportation, storage and distribution; and foreseeable uses – to determine the effect on its safety. Using production equipment as an example, a hazard evaluation would need to consider, among other things, whether the facility and equipment could introduce a hazard into foods.

One might consider, for example, whether the design of the equipment is conducive to thorough sanitation. Equipment that is difficult to clean, e.g., with niches, rough edges, close fitting parts, etc., can permit environmental pathogens to become established and potentially contaminate food. Also, equipment which requires metal-to-metal contact to function properly may generate metal fragments and therefore a hazard evaluation should consider the impact that potential physical hazards may have on the food.

As a further illustration, processing-related hazards should be evaluated to determine their impact on food safety. For example, hazards may arise from the cooling or holding of certain foods because of the potential for germination of pathogenic sporeforming bacteria (such as Clostridium perfringens) increases as a product reaches a temperature that will support germination. Also, toxins can be produced by Staphylococcus aureus or Bacillus cereus in a product that has been heated and then held at room temperature during processing if the product formulation supports growth and toxin formation and the bacteria are present. A facility should consider these factors and any other relevant factors that might potentially affect the safety of the finished food.

After the facility has prepared its written hazard analysis and determined that a hazard identified requires a preventive control, it must identify and implement preventive controls that will ensure that hazards will be significantly minimized or prevented. Accordingly, the next installment of this FSMA HARPC series will discuss preventative controls and it will appear on FoodProcessing.com.

Eric Lindstrom formerly was with Keller and Heckman LLP, now is with Lindstrom Food Law. This article provides information about the law. It does not, nor is it intended to, provide legal advice, which involves the application of law to an entity’s specific circumstances and depends on many factors.

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