82 12.6: The HACCP Principles (FDA)

12.6 The HACCP Principles (FDA)

Principle #1: Conduct a Hazard Analysis

A food safety hazard is any biological, chemical, or physical agent in food that could cause harm to consumers. Under HACCP principle one (Conduct a Hazard Analysis), facilities must systematically identify and evaluate risks at every production stage – from raw materials to final consumption. Biological hazards pose significant risks in food handling and require targeted controls due to their diverse transmission methods and survival mechanisms.

Biological Hazards in Food Safety

Bacterial Pathogens

Spore-forming bacteria: Bacillus cereus, Clostridium botulinum, and Clostridium perfringens produce heat-resistant spores that survive cooking. Their vegetative cells can regenerate if foods are improperly cooled below 135°F (57°C) or held in the “danger zone” (41°F–135°F/5°C–57°C).

Heat-sensitive bacteria: Salmonella and Campylobacter jejuni are destroyed by proper cooking but frequently cause illness through post-cooking cross-contamination.

Toxin producers: Staphylococcus aureus and Bacillus cereus create heat-stable toxins that persist even after reheating contaminated foods.

Viruses

Norovirus, hepatitis A, and rotavirus primarily spread through fecal-oral routes via contaminated hands, surfaces, or airborne droplets.

Key controls:

Restricting ill workers from handling ready-to-eat foods.

Using utensils/gloves for RTE foods.

Validated water sources for shellfish harvesting.

Parasites

Toxoplasma gondii, Cryptosporidium, and Anisakis spp. infect humans through undercooked meats/raw fish or cross-contamination.

Control strategies:

Cooking to ≥145°F (63°C) internal temperature.

Freezing fish at -4°F (-20°C) for 7 days for raw consumption.

Preventing cross-contact between raw and cooked foods.

Hazard Analysis Implementation

Facilities must:

Create process flow diagrams identifying contamination risks at each step.

Evaluate hazard severity based on consumer vulnerability (e.g., foods for immunocompromised populations).

Use scientific data from outbreak histories, microbial testing, and published research to justify control measures.

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This systematic approach ensures facilities address reasonably likely hazards – those with historical occurrence patterns, or plausible contamination pathways in their specific operations. For example, a deli would prioritize Listeria controls in cold storage areas, while a sushi restaurant focuses on parasite destruction in raw fish.

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Principle #2: Determine Critical Control Points

Critical Control Points (CCPs) are foundational to food safety systems, serving as strategically identified stages in food production where hazards can be effectively managed. Under the second HACCP principle, facilities must systematically determine these intervention points through rigorous analysis of biological, chemical, and physical risks.

Key Components of CCP Determination

Operational Definition: A CCP represents any step where control measures must be applied to prevent, eliminate, or reduce food safety hazards to acceptable levels. This differs from routine control points by its direct impact on consumer safety outcomes.

Hazard-Driven Identification: CCPs are established only for hazards deemed “reasonably likely to occur” during hazard analysis. Facilities must provide documented scientific justification when excluding potential hazards from CCP designation.

Process-Specific Variability: While cooking (thermal processing) and chilling (temperature control) are common CCPs, their necessity depends on a facility’s unique workflow. A metal detection step might be critical in ground beef production but unnecessary in juice bottling.

Multi-Hazard Control: Single CCPs often address multiple risks. For example, pasteurization would simultaneously control pathogens like Salmonella and Listeria. From a broader perspective, complex products might require multiple CCPs for one hazard across different processing stages.

Implementation Framework

Facilities use CCP decision trees to objectively evaluate whether a step meets CCP criteria. This structured approach asks:

Does this step eliminate or reduce the hazard?

Could contamination occur at or exceed hazardous levels here?

Will subsequent steps eliminate the hazard?

If hazards persist through subsequent steps, the current step qualifies as a CCP. Documentation must clearly map CCPs to specific hazards and justify their selection through scientific literature, regulatory standards, or experimental data.

Regulatory Expectations

The USDA mandates CCPs for all hazards identified as reasonably probable in federally inspected facilities while FDA guidelines emphasize CCPs as essential controls in juice and seafood HACCP plans. Both agencies require CCPs to be verifiable through measurable parameters like time, temperature, or pH levels.

Principle #3: Establish Critical Limits

Establishing critical limits is a foundational element of food safety management under the FDA Food Code and the Hazard Analysis and Critical Control Point (HACCP) system. Critical limits are specific, measurable thresholds that separate safe from unsafe conditions at each Critical Control Point (CCP) in the food production process.

What Are Critical Limits?

A critical limit is defined as the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a CCP to prevent, eliminate, or reduce the risk of hazard to an acceptable level. These limits are not arbitrary; they are based on scientific data, regulatory requirements, or authoritative guidance from agencies like the FDA, USDA, and CDC.

Key Characteristics of Critical Limits

Specificity: Critical limits must be clear and precise, such as a particular temperature, time, pH, or concentration.

Measurability: The limit must be easily and reliably measured during operations, enabling consistent monitoring and timely corrective action.

Validation: Critical limits should be validated through scientific literature, laboratory testing, or regulatory standards to ensure they effectively control the identified hazard.

Common Types of Critical Limits

Temperature:

Cooking poultry to an internal temperature of 165°F (74°C) to destroy Salmonella.

Maintaining cold storage at 40°F (4°C) or below to inhibit bacterial growth.

Time:

Holding pasteurized milk at 161°F for 15 seconds to achieve microbial reduction.

Cooling cooked foods from 135°F to 41°F within 6 hours to prevent spore formation.

pH and Water Activity (aw):

Acidifying canned tomatoes to a pH of 4.6 or below to prevent Clostridium botulinum growth.

Monitoring water activity to ensure it remains below levels that support pathogen growth.

Why Are Critical Limits Important?

Critical Limits act as safety boundaries. If a process exceeds or falls below these limits, it signals a loss of control at the CCP and triggers corrective actions to prevent unsafe food from reaching consumers. For example, if ground beef is not cooked to at least 160°F (71.11°C), there is a risk that E. coli may survive, posing a serious health hazard.

Practical Application of Critical Limits and Safety Margins

Manufacturers often set target limits slightly more stringent than the critical limits to provide a safety margin. This allows time to correct deviations before the actual critical limit is breached, ensuring consistent food safety.

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Examples from the FDA, USDA, and CDC literature:

FDA Food Code: Requires specific temperature and time controls for cooking, cooling, and holding foods to minimize pathogen risks.

USDA FSIS: Publishes safe minimum internal temperatures for meats and poultry and mandates zero tolerance for fecal contamination on poultry entering the chiller.

CDC: Provides outbreak data and risk analysis that inform critical limit recommendations, particularly for vulnerable populations.

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Critical Limits Summary Points:

Critical limits are the dividing line between safe and unsafe food processing conditions.

They must be based on scientific evidence and regulatory standards, not arbitrary choices.

Examples include:

Minimum cooking temperatures for meats and poultry.

Maximum storage temperatures for perishable foods.

Maximum allowable levels of chemical residues or contaminants.

Monitoring and documentation are essential to verify that critical limits are consistently met.

If a critical limit is exceeded, immediate corrective action is required to restore control and ensure food safety.

Critical limits should be reviewed and updated as new scientific information or regulatory requirements become available.

Establishing critical limits is a science-based, regulatory-driven process that ensures food safety by setting clear, measurable boundaries at each CCP. These limits are validated, monitored, and strictly enforced to protect public health, as outlined in FDA, USDA, and CDC documents.

Principle #4: Monitoring Procedures

Monitoring procedures are a cornerstone of the Hazard Analysis and Critical Control Points (HACCP) system and are required by the FDA Food Code, USDA, and CDC guidance. Monitoring is the systematic process of observing and measuring specific parameters at each Critical Control Point (CCP) to ensure that established critical limits are consistently being met and maintained. This process is essential for detecting deviations from food safety standards before they pose a risk to public health.

Purpose and Importance of Monitoring

Verification of Critical Limits: Monitoring confirms that CCPs are operating within the defined safety parameters, such as temperature, time, or pH.

Early Detection: By providing real-time or regular data, monitoring allows for immediate corrective actions if a process deviates from its critical limits, preventing food safety hazards from escalating.

Documentation and Compliance: Monitoring produces records that are essential for demonstrating regulatory compliance during audits or inspections.

Continuous Improvement: Data from monitoring activities can be analyzed to refine processes and enhance overall food safety management.

Monitoring Activity Examples:

Monitoring activities can be categorized into two main types: measurements and observations.

Measurements (Quantitative Monitoring):

Checking internal temperatures of cooked foods (e.g., verifying chicken reaches 165°F after cooking).

Recording oven or fryer temperatures and the time required to achieve critical limits.

Measuring pH levels, such as ensuring acidified sushi rice has a final pH below 4.

Assessing water activity or chemical residue using appropriate test kits.

Observations (Qualitative Monitoring):

Visually inspecting date marking systems in delis to control Listeria monocytogenes in ready-to-eat meats.

Observing employee hygiene practices or the cleanliness of food contact surfaces.

Checking for proper labeling and packaging of food products.

How Monitoring Is Conducted

Document the parameter monitored, frequency, results, responsible individual, and any corrective actions taken. Monitoring can be performed using different methods depending on the process and the hazard being controlled:

Continuous Monitoring: Utilizes automated systems (e.g.), temperature sensors, and data loggers to provide uninterrupted data, ideal for critical processes like pasteurization or cook-chill operations. Preferred when feasible, as it provides the most comprehensive data on CCPs.

Intermittent (Periodic) Monitoring: Involves manual checks at set intervals, such as visual inspections or manual temperature readings. This is suitable for processes where continuous monitoring is not feasible. Should be frequent enough to ensure that critical limits are consistently met. The frequency depends on the product, process, and risk level (e.g., water safety may be checked annually or more often depending on the source).

Tools and Technology Used:

Calibrated thermometers (digital or analog)

pH meters

Scales for portion control

Metal detectors

Allergen test kits

Who Conducts Monitoring and Record Keeping?

Monitoring is typically performed by individuals properly trained in monitoring techniques

directly involved in the operation, such as the person in charge, chefs, or departmental supervisors.

Training records and verification of staff knowledge are essential components of a robust monitoring program.

Accurate record-keeping is required to demonstrate compliance with HACCP and regulatory requirements by providing a historical record for audits, investigations, or process improvement.

Summary Table: Monitoring Procedures.

Principle #5: Establish Corrective Actions

What Are Corrective Actions?

Corrective actions are immediate, targeted steps taken when a critical limit (CL) in a food safety process is not met. These actions are essential components of a Hazard Analysis Critical Control Point (HACCP) system and are mandated by the FDA Food Code, USDA regulations, and reinforced by CDC surveillance efforts.

Key Aspects of Corrective Actions

Specific: Each corrective action must address the particular deviation at each Critical Control Point (CCP). For example, if a batch of hamburgers does not reach the required internal temperature of 155°F (68.33°C) for 17 seconds, the corrective action could be to continue cooking until the proper temperature is achieved.

Immediate and Comprehensive: Corrective actions must be implemented as soon as a deviation is detected. All food products affected during the monitoring period must be controlled, which may involve holding, segregating, or discarding potentially unsafe food.

Documented: Every corrective action taken must be recorded, including details about the deviation, the steps taken, and the personnel involved. This documentation is crucial for regulatory compliance and traceability.

What is a Corrective Action Plan?

A written Corrective Action Plan is required for each identified hazard and CCP. The plan should clearly outline:

Who is responsible for implementing corrective action?

Step-by-step procedures for addressing deviations.

Criteria for determining the disposition of affected products.

Documentation and record-keeping protocols.

Steps in Corrective Action Procedures:

Stop the process and segregate affected product.

Adjust the process to bring the CCP back under control and correct the cause of the deviation.

Document all actions taken.

Consult with the HACCP team and, if necessary, regulatory officials (especially under USDA/FSIS oversight).

Follow the product disposition plan, which may include further processing, holding, or discarding the product.

Review and, if needed, modify the HACCP plan to prevent recurrence.

Examples of Corrective Actions

Discarding food that poses an unacceptable safety risk.

Re-cooking or reheating food to reach the required temperature.

Calibrating equipment that was found to be malfunctioning.

Isolating and holding product until safety can be verified.

Why Are Corrective Actions Important?

Protect Public Health: They prevent unsafe food from reaching consumers, thereby reducing the risk of foodborne illness.

Regulatory Compliance: Both FDA and USDA require that corrective actions are documented and reported as part of HACCP and preventive controls regulations.

Continuous Improvement: Reviewing corrective actions helps identify trends and recurring issues, informing updates to food safety plans and processes.

Agency Roles

FDA: Sets the scientific standards for corrective actions in the Food Code and enforces preventive controls under the Food Safety Modernization Act (FSMA).

USDA: Oversees corrective actions in meat, poultry, and egg products, requiring immediate response and documentation for any deviation from critical limits.

CDC: Monitors foodborne illness trends and outbreaks, providing data that can inform the effectiveness of corrective actions and highlight areas needing improvement.

Principle #6: Establish Verification Procedures

Verification, according to the FDA Food Code 2022, Annex 4 refers to activities distinct from routine monitoring that confirm the validity of a HACCP (Hazard Analysis and Critical Control Points) plan and demonstrate that food safety systems are operating as intended. In essence, verification answers the question: Are we doing what we say we do, and is it working as planned? This principle is critical for maintaining active managerial control over foodborne illness risk factors.

The FDA defines verification as “the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended”.

The USDA and CDC similarly emphasize that verification ensures compliance with food safety plans and that hazards are effectively controlled.

Validation, a component of verification, involves collecting and evaluating scientific and technical data to confirm that the HACCP plan, when properly implemented, will control hazards as intended.

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Key Points About Verification:

Verification is not the same as monitoring; it is a separate, higher-level check of the system.

Validation is a subset of verification, focusing on scientific proof that the plan will control hazards if followed.

Verification activities should be clearly assigned, with responsibilities, frequency, and procedures documented in the HACCP plan.

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Verification activities must be performed at regular intervals to ensure ongoing food safety. The frequency depends on the complexity of the operation, the risks involved, and regulatory requirements.

Activities may be conducted daily, weekly, monthly, or at other intervals specified in the HACCP plan or required by regulatory agencies. The frequency should be sufficient to provide reasonable assurance that hazards are consistently controlled and that the HACCP plan is being properly implemented. Regulatory bodies such as the FDA and USDA may require more frequent verification for higher-risk processes or products.

Examples of Verification Activities

Verification encompasses a variety of tasks designed to ensure the HACCP system is working as intended. Common examples include:

Observation of Monitoring Activities: Supervisors watch employees perform monitoring tasks (e.g., checking cooking temperatures) to ensure procedures are followed correctly.

Review of Monitoring Records: Regular examination of logs and records to confirm they are accurately and consistently completed as required by the HACCP plan.

Assessment of Monitoring Frequency: Ensuring that monitoring is performed as often as specified in the plan and that no steps are skipped.

Corrective Action Review: Confirming that appropriate corrective actions were taken and documented when a critical limit was not met.

Validation of Critical Limits: Periodically reviewing scientific data or conducting in-plant studies to verify that established critical limits effectively control hazards.

Equipment Calibration and Maintenance: Checking that monitoring equipment (e.g., thermometers, pH meters) is properly calibrated, maintained, and functioning accurately.

Supplier Verification: Conducting onsite audits, reviewing supplier food safety records, and testing ingredients to ensure suppliers control hazards as required by the FDA’s Food Safety Modernization Act (FSMA).

Internal and External Audits: Regular audits by internal staff or third-party experts to assess overall compliance with the HACCP plan and food safety regulations.

Verification is a cornerstone of food safety management, ensuring that the entire HACCP system is not only designed well (validation) but also implemented effectively and consistently. For example, a food processing facility might verify that cooking temperatures are being monitored by both reviewing temperature logs and directly observing the cooking process. If a deviation occurs-such as a batch not reaching the required temperature-verification procedures confirm that corrective actions (e.g., re-cooking or discarding the batch) are carried out and documented.

The USDA requires meat and poultry processors to conduct verification and validation activities as part of regulatory compliance, with inspectors performing their own verification checks. The CDC emphasizes that such procedures are essential for preventing outbreaks of foodborne illness by ensuring that hazards are systematically identified and controlled.

Principle #7: Establishing Record Keeping Procedures

Records serve as documented evidence that critical food safety activities-such as monitoring,

corrective actions, and verification-have been properly executed. This documentation is essential for several reasons:

Verification and Compliance: Records provide proof that food safety protocols, such as those outlined in a HACCP plan, have been followed. This is crucial for demonstrating compliance with FDA, USDA, and CDC regulations.

Corrective Action Documentation: When critical limits are not met, records show that appropriate corrective actions were taken, which can help prevent recurrence and demonstrate due diligence.

Legal Protection and Liability: In the event of a foodborne illness outbreak, well-maintained records can provide evidence that reasonable care was exercised, potentially protecting the business from liability.

Continuous Improvement: Analyzing records helps identify trends, root causes of issues, and gaps in training, enabling ongoing improvement of food safety processes.

Traceability and Rapid Response: Under the Food Safety Modernization Act (FSMA) and the Food Traceability Rule, records allow for the rapid identification and removal of contaminated foods from the market, reducing the risk of foodborne illnesses and deaths.

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“Records allow the food business to easily and confidently confirm that its HACCP plan is effective. Records can also provide information for identifying and addressing the root cause of an issue, analyzing data and identifying trends to continuously improve a process or procedure, and identifying gaps in training…”

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Types of Records Required

A robust food safety management system maintains several types of records, each serving a specific purpose:

Prerequisite Program Records: Document foundational activities such as sanitation, employee training, and supplier approval.

Monitoring Records: Capture observations or measurements at critical control points (CCPs) to ensure critical limits are consistently met.

Corrective Action Records: Detail the actions taken when monitoring indicates a deviation from established critical limits.

Verification and Validation Records: Show that monitoring and corrective actions are effective and that the food safety system as a whole is functioning as intended.

Calibration Records: Document the calibration of equipment to ensure accuracy in measurements and monitoring.

Supplier Program Records: Demonstrate the adequacy and compliance of suppliers with food safety requirements.

Training Records: Provide evidence that personnel have received appropriate food safety training.

Electronic records are acceptable if they are protected from unauthorized changes and backed up regularly. All records must be retained for at least two years after their creation, or longer if required by specific regulations (e.g., for the shelf life of certain products). Records must be readily accessible and provided to regulatory authorities within 24 hours upon request.