HACCP & HARPC

HACCP (Hazard Analysis and Critical Control Point) is a systematic approach to food safety that focuses on preventing contamination from biological, chemical, physical and radiological hazards using common sense application of scientific principles.

It is accepted worldwide as a suitable system for ensuring food safety and is a legal requirement or recommended for food business in most developed countries.

Examples of hazards assessed by an HACCP system include bacteria, viruses, insects, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food and colour additives, chemical contaminants from equipment and building maintenance, radioactive compounds, glass, wood, stone, bone, plastic and metal fragments and objects.

Implementation of HACCP benefits both the consumer and the business processing or preparing food. The FDA lists the following advantages for businesses:

• reduction in product loss;
• increase in product quality;
• better control of product inventory;
• consistency in product preparation;
• increase in profit; and
• increase in employee awareness and participation in food safety.

Adherence to HACCP principles also opens new markets for businesses in supplying companies requiring high quality products and in international trade where compliance with internationally recognised standards is required.

An HACCP system is applied in a logical sequence with a set of preparation stages:

1. Assemble the HACCP team. The appropriate knowledge and expertise should be made available by assembling a multidisciplinary team from onsite or offsite sources that can develop an HACCP plan.
2. Describe the product, including its composition, physical and chemical structure, packaging, durability, storage conditions and distribution methods.
3. Identify intended use by the end user or consumer.
4. Construct a flow diagram covering all steps in the processing of a specific product.
5. Confirm the flow diagram onsite.
6. List all potential hazards associated with each step, conduct a hazard analysis and consider measures to control the hazards.

Identify which steps in the process are needed to ensure food safety and if a control measure is missing modify the process to include a control measure.

Each critical control point must have validated measurable limits that define boundaries to ensure food safety. One CCP can have more than one limit, for example, temperature, moisture level, pH, time.

Monitoring involves scheduled measurement or observation of a CCP that can detect a process moving outside the critical limits. Ideally it should enable action to be taken before a critical limit is reached. Measurements often have to be rapid therefore physical and chemical measurements are usually preferred.

There should be plans for corrective action to be taken for when CCPs are breaching limits and staff should be ready and trained to implement them.

Verification procedures confirm that all elements of the systems of hazard control are working effectively.

Verification procedures include: review of the HACCP plan and records; review of deviations and product dispositions; confirmation that CCPs are controlled.

It can also involve checking people and processes are working correctly and that monitoring equipment is working correctly.

An effective HACCP system requires efficient and accurate record keeping and documentation to show that the system is active and effective. This includes the HACCP plan itself and any monitoring, corrective action or calibration records produced in the operation of the HACCP system.

It has long been recognised that the management of food safety could be improved by including a risk analysis approach. This uses a science-based analysis of food safety factors and tying the system to public health outcomes.

Risk analysis is established in the Codex Alimentarius and has passed into the EU General Food Law Regulation.

The objective of applying risk analysis to food safety is the protection of human health. Codex Alimentarius recommends that it is established as an integral part of national food safety systems. Risk analysis should be:

• applied consistently;
• open, transparent and documented; and
• evaluated and reviewed as appropriate in the light of newly generated scientific data.

Risk-analysis methods for food safety have been developed jointly by WHO and FAO and implemented in the Codex Alimentarius for many years. These are used as the basis for food safety standards by food standards bodies.

Three staged structured approach to risk analysis:

The scientific evaluation of known or potential adverse health effects from exposure to foodborne hazards using the following steps:

• Hazard identification: the identification of known or potential health effects associated with a particular agent.
• Hazard characterization: qualitative and/or quantitative evaluation of the nature of the adverse effects associated with biological, chemical, and physical agents which may be present in food.
• Exposure assessment: qualitative and/or quantitative evaluation of the degree of intake likely to occur.
• Risk characterization: integration of the previous steps into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainties. It includes quantitative and qualitative assessment, as well as an indication of the attendant uncertainties.

Risk management follows a structured approach to determine and implement the appropriate options. It consists of four components:

• Preliminary risk management activities. The establishment of a risk profile to provide as much information as possible to guide further action.
• Evaluation of risk management options. This involves assessing the options for managing a food safety issue taking account of scientific information on risks and other factors. Optimization of the efficiency, effectiveness, technological feasibility and practicality of food control measures at selected points throughout the food-chain is an important goal.
• Implementation of the risk management decisions. Implementation involves regulatory food safety measures, such as the use of an HACCP system. It is essential to continuously verify the application of food safety measures.
• Monitoring and review. This consists of gathering and analyzing data to give an overview of food safety and consumer health. Monitoring should identify new food safety problems as they emerge and indicate where redesign of food safety measures is needed to achieve the required public health goals.

Communication is an integral part of the risk analysis and all stakeholder groups should be involved from the start to exchange information and opinion and ensure the process, outcomes, significance and limitations are understood.

Stakeholders include risk assessors, risk managers, and other interested parties.

The identification of interest groups and their representatives should comprise a part of an overall risk communication strategy.

• When the risk analysis process has identified the hazards and decided on and assessed the appropriate risks, then this information should be prepared and disseminated to stakeholders.
• This will be followed by further discussions with stakeholders, to identify corrections, amendments, and additions as appropriate, and then produce the final risk assessment and risk analysis reports.

HARPC (Hazard Analysis and Risk-Based Preventive Controls) is a recent adaptation of the HACCP system for certain businesses in the USA that come under the Food Safety and Modernisation Act (FSMA). FDA regulation for several decades has been based on good manufacturing practices (GMP) for specific foods and reacting to hazards after they happen. The new law aims to make businesses implement preventive procedures to minimize risk of hazards based on scientific evidence.

The final rule for preventive controls in human food was issued by the FDA in September 2015 and requires compliance for large businesses within one year — by September 2016.

Businesses not included are mainly those defined as small businesses and certain product processors and importers. The use of HACCP systems is mandated for the juice and seafood businesses, while it is voluntary for retail & food service businesses. It is also voluntary for the dairy industry because there is an alternative system already in use.

The details of the HARPC requirements are still being developed, with the FDA developing guidance documents to help business.

Section 103 of the Food Safety Modernization Act describes an HARPC as: “The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.”

HACCP is generally based on controlling unintended contamination in the food supply chain. A move in the focus of food safety was stimulated by terrorist attacks, particularly those of 9/11/2001, when more emphasis was put on protecting food and drink supply chains from all kinds of malicious interventions.

The BSI Publicly Available Specifications (PAS) 96:2014 is a fast-tracked temporary standard that outlines a risk management methodology to plan for a wide range of external and internal threats. It guides food business managers through the procedures for improving the resilience to threats and mitigating the consequences of such attacks.

PAS96:2014 uses a risk management methodology called Threat Assessment Critical Control Points (TACCP) to assess the entire production process and food chain as part of a business’s wider risk management strategy.

The types of threat include:

• economically motivated adulteration (EMA);
• malicious contamination;
• extortion;
• espionage;
• counterfeiting; and
• cybercrime.

Codex Alimentarius. General principles of food hygiene. CAC/RCP 1-1969 (Rev 4-2003 – Annex).

Codex Alimentarius. Working Principles for Risk Analysis for Food Safety for Application by Governments. First edition. WHO/FAO, Rome 2007.

Introduction to HACCP
https://food.unl.edu/introduction-haccp-training

Buchanan RL. Understanding and Managing Food Safety Risks. Food Safety Magazine, Dec 2010-Jan 2011.
https://www.foodsafetymagazine.com/magazine-archive1/december-2010january-2011/understanding-and-managing-food-safety-risks/

Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments. 

Eric Lindstrom. Do you know your HACCP from your HARPC? Food Processing Magazine. March 2013.
https://www.foodprocessing.com/articles/2013/fda-haccp-harpc/