The Food Safety Modernization Act will soon have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA. The Preventive Controls for Human Foods proposed rule, which is expected to be published as a final rule this month, will significantly change the way food manufacturing companies document their food safety systems. The traditional approach of using the HACCP (Hazard Analysis Critical Control Point) system will transition to the new HARPC (Hazard Analysis Risk-Based Preventive Controls) system. The change will be required by the new FDA regulatory standard defined in 21 CFR 117.26(a).
Food Safety Plan Requirements
FDA regulated facilities will be required to have a written and implemented Food Safety Plan. The Food Safety Plan must include the following contents:
The Food Safety Plan requirements are much more comprehensive than the traditional HACCP plan by itself. A HARPC hazard analysis includes more detailed hazard identification and hazard evaluation
Under HARPC preventive controls encompass numerous prerequisite programs including:
- Process controls
- Supplier controls
- Recall plan
- Hygiene training
- AND MORE!
Supplier and recall programs will become formal. Additionally, environmental monitoring as well as corrective and verification procedures will apply not only to critical control points (CCP’s), but to other preventive controls identified and documented by each plant.
As you prepare for the journey to transition from HACCP to HARPC, there are key steps on the way to become prepared and compliant. Focus on the following steps to help you understand and be successful:
Step 1 – Education and Training
The first stop is to take time to educate yourself on the new regulatory requirements and this new approach to your food safety system. The new regulations actually require food safety plans to be developed and reassessed by a “Qualified Individual.”
The proposed rule states a qualified individual must have successfully completed training in the development and application of risk-based preventive controls. Training must be equivalent to a standardized curriculum recognized as adequate by FDA.
It is recommended to attend an accredited HARPC training workshop such as the one offered by Alchemy or others to meet this criteria. The proposed rule does also state that job experience may be used to meet the criteria of a “qualified individual” if such experience includes developing and applying a food safety system, and knowledge at least equivalent to that provided through the standardized curriculum.
There is so much to learn about the regulations and this different approach to food safety that participation in a comprehensive training workshop is highly recommended.
Step 2 – Hazard Analysis
The hazard analysis identified in the 21 CFR 117.130 requirement looks substantially different than the hazard analysis under traditional HACCP Plans. The Hazard analysis is a two-step process: hazard identification and hazard evaluation. The primary differences identified in the proposed rule fall under hazard evaluation.
Hazard evaluation must include an assessment of the potential severity of injury or illness, and the probability that the hazard will occur in the absence of controls. This will require a quantitative risk assessment approach for all hazards identified.
- Radiological hazards must be considered
- Hazards that may be unintentionally introduced must be considered
- Hazards that may be intentionally introduced for purposes of economic gain must be considered
The hazard evaluation phase must also consider the effect of the entire manufacturing process including raw materials, formulation, storage and distribution and sanitation. Even extrinsic factors such as transportation practices and intended or reasonably foreseeable use must be included during this evaluation phase. This approach will require reassessments of existing hazard analysis, and changes the format of documentation. All the required information must be recorded.
Step 3 – Preventive Controls
Preventive controls are applicable to both CCP controls, and many programs often considered to be prerequisite programs. Preventive controls include process controls that are often associated with CCP’s such as cooking, chilling, temperature controls, pH control, and water activity (Aw) control.
Process controls must identify key control parameters including maximum or minimum values (i.e. critical limits or control limits) to be able to assess if the process is in control or not. Process controls specific to a manufacturer’s products, raw materials, processes and environmental factors must also be considered.
At a minimum, documentation of preventive controls required by the proposed rule include:
- Supplier controls
- Recall plan
Step 4 – Reanalysis
The Food Safety Plan will be required to be reassessed at the following times:
- Once every three years
- Whenever a significant change is made in activities conducted at the facility
- Whenever plants become aware of new information about potential hazards associated with the food
- After an unanticipated food safety problem occurs
- Whenever a preventive control is found to be ineffective
- Whenever FDA determines it is necessary to respond to new hazards and developments
It will be imperative to document a Food Safety Plan that meets the regulatory requirements and to reassess the plan as often as necessary based on the events above. The food safety plan should always be a living document that accurately represents your processes and controls.
There is some confusion over Hazard Analysis and Critical Control Points and the more-recent food-safety plan, Hazard Analysis and Risk-Based Preventive Controls. Here are the key differences.
Both Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) are discussed, almost interchangeably, albeit incorrectly, in food-processing circles. The truth is that if you were to ask most food processing professionals to explain the differences between the two, the answer may not come so easily.
HACCP is a global standard, developed in the late 1950s and early 1960s by a team of engineers and scientists from three distinctly different organizations. Pillsbury, the Army’s Natick Research Labs, and the National Aeronautics and Space Administration (NASA) joined forces to draft and adopt a global, food-safety standard in keeping with, and as part of, the Codex Alimentarius. The Codex commission was established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in 1963. HACCP was originally developed as a way to ensure built-in quality and food safety, specifically for the manned space program, though it has evolved greatly since that point in time.
HACCP’s evolution has been continual, resulting in an effective and efficient, comprehensive food-safety management system (FSMS). Pillsbury publicly presented the HACCP concept at the 1971 National Conference on Food Protection, jointly sponsored by the Food and Drug Administration (FDA) and the American Public Health Association (APHA). In 1974, the FDA incorporated its concepts into its low-acid and acidified-food regulations. By the end of the 1980s, McDonald’s started requiring all of its suppliers to adhere to HACCP in order to ensure the safety of the food being served in its restaurants. Spurred by the marketplace, rather than legislation or regulation, other large companies followed suit and HACCP became the standard by which to measure food safety.
In 1989, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), published the first official HACCP document, standardizing the practice and presenting the seven principles of HACCP: (1) Hazard Analysis, (2) Critical Control Point Identification, (3) Establishment of Critical Limits, (4) Processes for Monitoring, (5) Corrective Actions (6) Record Keeping, and (7) Establishment of Verification Procedures . The rest, as they say, is history.
Moving forward, HARPC is not a global standard, but an updated U.S. standard incorporated into the Food Safety Modernization Act (FSMA) on July 4, 2012. Whereas HACCP generally applies to low-acid, canned food, juice, and seafood processors, HARPC applies to almost all food-processing facilities. The only facilities not required to comply with HARPC are those subject to the Standards of Produce Safety, those already governed by HACCP, and those facilities regulated by Good Manufacturing Practices (GMP) for Dietary Supplements. Small and very small business entities, as defined by the FDA are also exempt.
- HARPC mandates that facilities:
- Conduct a thorough hazard analysis for all food-processing procedures
- Develop and implement preventive controls, and then monitor the controls’ effectiveness
- Provide a detailed plan in writing, describing how the hazards will be controlled, the preventive controls put in place, and a schedule and methodology for monitoring the efficiency of the controls
- Verify the effectiveness of the controls, also maintaining written records of the verification processes
- Reanalyze the HARPC plan at least every three years; more often as new product lines are added, equipment is changed or upgraded, and/or when other changes require a new analysis
Finally, unlike HACCP, HARPC includes planning for potential terrorist acts and/or intentional adulteration and food fraud. A facility’s HARPC, food-defense plan should include additional security, such as visitor access and control.To put it even more simply, if you have an effective HARPC plan in place, you are also in compliance with HACCP mandates. If, however, you currently function under HACCP guidelines, it is your responsibility to determine if you must comply with HARPC under FSMA.