In the first two articles in this series, Life Sciences Decoded explored the FDA’s new Rule revamping the food Good Manufacturing Practices (cGMPs) and creating the new Hazard Analysis and Risk-Based Preventive Controls requirements (HARPC). In Part I we looked at the history and purpose behind the FDA’s new Rule, and in Part II we compared the old cGMPs to the new revised regulations in order to better understand some of the FDA’s new focus points. In this third and final part of this series, we look at the new HARPC rule and its impact on the food industry.
What is HARPC?
As we discussed in Part I, HARPC is related to the Hazard Analysis and Critical Control Points (HACCP) program that has been in place for some time for seafood, juice, retail food establishments and (voluntarily) for dairy processors. The core concept of HARPC, which is based heavily upon HACCP principles, is that food manufacturers or processors must take proactive steps to identify the risks inherent to food they handle and create processes, procedures, and record-keeping systems to identify and reasonably minimize those risks. In addition, HARPC requires reactive plans should one of those risks be realized, and those plans must contain clear procedures to eliminate the risks, thereby preventing them from causing consumer harm.
What must a HARPC plan contain?
HARPC requires a plan that contains four parts: i) identifying hazards relative to the products produced and the environment in which those products are produced; ii) creating preventive controls to prevent those hazards from occurring; iii) monitoring; and iv) responding to situations where a risk occurs (this could be because either the preventive control failed or an unforeseen risk arose). The overall focus of this rule requires these plans to continue the FDA’s efforts to ensure the safety of the U.S. food supply and, therefore, each of these plans should be drafted with this in mind.
Part One: Analysis of Hazards. The HARPC rule is designed to promote self-identification by the food manufacturer or processor of all reasonably known or foreseeable hazards related to its food products or ingredients produced, as well any such hazards promoted by the environment in which those products are produced. It is interesting to note that in the FDA’s response to comments to the rule, it specifically recognized that a company, in going through the process of hazards analysis, could determine that there are no hazards related to the product and, therefore, no preventive controls are required for that product.
The rule categorizes hazards to be identified into four classes:
- Biological hazards: Microbial hazards including, but not limited to, parasites, environmental pathogens, bacteria, and fungi.
- Chemical hazards: All non-living hazards in chemical form from pesticides, cleaning agents, production byproducts, natural toxins, decomposition, unapproved foods or additives, and food allergens. As we mentioned in Part II, food allergens are an increasing point of focus in FDA enforcement procedures and in the new regulations.
- Physical hazards: Contaminants that pose risks based on their physical nature and include any foreign materials (such as glass), personal items deposited in food product by employees, or other contaminant that is not a chemical contaminant or living organism.
- Radiological hazards: The rule requires that a company or facility consider, for each product, the likelihood of radiological hazards using the “known or reasonably foreseeable” standard in that evaluation. If it is determined that a radiological hazard is neither known nor reasonably foreseeable for the product, then that determination must be noted in the HARPC plan. The FDA recognizes that it is unlikely that radiological hazards would be identified, and when they occur it is more likely than not to be an intentional act constituting adulteration.
This identification process anticipates an evaluation of each identified hazard, an assessment of the severity of that hazard and the probability of the identified hazard actually occurring. This evaluation process should be documented in order to show how it supports the final evaluation of each hazard. Hazard evaluations should include an examination of all relevant processes, including without limitation the following: formulation; condition and function of the facility and equipment; raw materials and ingredients; transportation; packaging; sanitation; and manufacturing. Once hazards have been identified and evaluated, preventive controls must be put in place to avoid, or (where avoidance is impossible) minimize the hazard to ensure a safe food supply.
Part Two: Create Preventive Controls. Once hazards have been identified and evaluated, preventive controls must be implemented at the critical control points. These preventive controls must be in writing and part of a food safety plan. The preventive controls must include the process controls that are the procedures and practices to be implemented to effectuate those preventive controls. These controls should include checkpoints with verifiable values (pH, temperature, process records, etc.) that can be enforced and recorded by employees in the facility. Training employees on controls is critical.
In addition, the comments to the final rules specifically recognize that preventive controls include food allergen controls, when appropriate, depending on the product. These allergen controls must address cross-contamination issues. The comments also discuss the need for sanitation controls related to the food facility to ensure clean and sanitary conditions for the food during manufacturing, processing and packing. Supply chain controls are also required to be included in the food safety plan. There are some instances where preventive controls are not required. For example, there is no requirement in those instances: i) where the product cannot be consumed without the application of a control; or ii) where the processor relies on its customer, who is subject to the requirements for hazard analysis, to ensure that the identified hazard will be addressed and there is a documentation chain in place to ensure that the hazard is being addressed downstream.
Part Three: Monitoring the Food Safety Plan. As a part of the significant record-keeping requirements placed on those subject to the HARPC Rule, facilities must keep ongoing records of all facility operations. These records must be retained for at least two years, with at least six months of on-site access. Documentation must be included that demonstrates that the plan is reviewed regularly and updated as needed. The plan needs to also be monitored for effectiveness in order to demonstrate that it is designed to identify hazards, the hazards have been evaluated, and controls are in place. There also needs to be documentation that the process controls have been implemented and are being followed.
Part Four: Recalls and Corrective Action. If the preventive controls fail to identify and remedy adulterated or otherwise unsafe product before it reaches the marketplace, each food safety plan must include a process for recalls and implementation of corrective actions that not only remedy the failure but also correct the cause of the failure or adulteration going forward. These processes must be in writing, and in the event of a recall or corrective action, all responses and actions must be documented. To the extent the food safety plan did not address the failure or issues that occurred, the food safety plan will have to be amended.
The HARPC regulatory emphasis on pre-emptive analysis of an establishment’s risks is an important concept in the new HARPC Rule. In crafting a HARPC (or HACCP) plan, food companies will need to create a team of qualified individuals dedicated to understanding their internal processes, from sourcing and receiving raw ingredients through the manufacturing process, including the packaging and shipping of finished product. This team must consist of employees in leadership positions, facility managers and process employees so that the team can best understand: i) where the most likely risks to finished products occur, ii) how they can be addressed, and iii) how they can be minimized. This team must also be involved in the record-keeping and corrective action plan creation process. These activities, as well as the monitoring and preventive controls activities, may be created by the HARPC team, but they will be implemented by the facility managers and line employees. Getting these managers and employees involved during the HARPC drafting process is vital to crafting a HARPC plan that not only complies with FDA regulatory requirements but also makes sense for the company’s daily business and manufacturing activities.
Moving forward, the FDA plans on releasing a series of guidance documents that will further expand upon and explain the scope of the new food safety plan requirements. These include:
- Hazard Analysis and Preventive Controls
- Environmental Monitoring
- Food Allergen Controls
- Validation of Process Controls
- A Small Entity Compliance Guide
At Thompson Coburn, we have a team of attorneys with experience in assisting our clients in evaluating hazards the Rule is intended to address, create processes acceptable to prevent risks from becoming reality, and creating and drafting HACCP plans and food safety plans compliant with FDA regulatory requirements. If you have any questions or would like assistance with reviewing your company for compliance, please contact Diane Romza-Kutz.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.