HACCP

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.

HACCP Plan

A food business should first develop and implement the facilities and procedures that establish basic food safety conditions and provide the foundation for a food safety management system.

The ability to implement an HACCP plan depends on how well these foundations are built and maintained.

A prerequisite programme can include:

• vendor certification programs;
• training programs;
• allergen management;
• buyer specifications;
• recipe/process instructions;
• first-in-first-out (FIFO) procedures;
• standard operating procedures (SOPs) to protect products from contamination by biological, chemical and physical food safety hazards and control bacterial growth;
• standard operating procedures for maintaining equipment, such as:
  • food contact utensils and surfaces are clean, hygienic and maintained in good condition;
  • devices and equipment are routinely checked, maintained and calibrated;
  • staff toilet and hygiene facilities are suitable and maintained.

Business advantages of HACCP

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.

Application of HACCP

There is no single correct application of HACCP and it is recognised that it should be flexible to apply to different types and size of business.

In the US, use of the system is voluntary for retail and food service businesses and adaptable to the size of the business, though an equivalent food safety management system is expected to be in place.

The EU food law states that HACCP requirements should take account of principles in the Codex Alimentarius. But whichever system is used, the ultimate responsibility for food safety resides with the business processing or preparing food.

Preparation

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.

Seven principles of HACCP

There are seven principles recognised in an HACCP system:

1. Conduct a hazard analysis

This lists all the hazards that may occur at each step from primary production, processing, manufacture, and distribution until the point of consumption. It requires knowledge of how the people, equipment, methods, and foods affect each other.

It assesses the likely occurrence of hazards and severity of their adverse health effects; a qualitative and/or quantitative evaluation; survival or multiplication of biological hazards; production or persistence in foods of toxins, chemicals or physical agents.

2. Identify critical control points (CCPs)

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.

3. Establish critical limits for CCPs

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.

4. Establish monitoring procedures

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.

5. Establish corrective actions

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.

6. Establish verification procedures

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.

7. Establish record-keeping and documentation procedures

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.

Risk management

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.

In the US in the more recent Food Safety and Modernization Act (FSMA) requires certain food processing businesses to implement an HACCP system with risk analysis, which the FDA calls Hazard Analysis and Risk-Based Preventive Controls (HARPC).

Codex Alimentarius approach

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:

1. Risk assessment

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.

2. Risk management

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.

3. Risk communication

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

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 Modernization 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 impact for businesses

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.”

Seven principles of HARPC

Interpretation of HARPC by others (media, industry consultants) shows that it follows the seven basic principles of HACCP, but with the obvious emphasis on implementing preventive controls:

1. Conduct a hazard analysis.
2. Identify critical control points (CCPs) and develop and implement risk-based preventive controls at the critical points of the manufacturing process. This is the key difference in the new legislation. The FDA lists these as including process, food allergen and sanitation controls, supply chain controls and a recall plan.
3. Establish monitoring procedures.
4. Establish corrective actions.
5. Establish verification procedures.
6. Establish record-keeping and documentation procedures.
7. Reanalyze the HARPC system: every three years; when there is a significant change in the facility; and when threats are identified by the Department of Homeland Security.

Threat assessment

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 US, particularly, took a rapid response in passing the Bioterrorism Act of 2002 which included measures to protect food supplies from deliberate attack.

The FDA introduced the CARVER + shock system adapted from a US military threat analysis system for assessing the potential effects at a population level of attacks on food supply chains.

BSI PAS 96 & TACCP

The BSI Publicly Available Specification (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.

FDA CARVER + shock method

In the US, food processors use the CARVER + shock method to assess vulnerabilities within a system or infrastructure to an attack. The methodology was developed by the US military to identify areas vulnerable to attack. It uses seven attributes graded on a scale of 1-10 according to FDA guidelines:

• criticality;
• accessibility;
• recuperability;
• vulnerability;
• effect — direct loss in production;
• recognisability — ease of identifying target;
• shock.

Examples of risk-based preventive controls include hygiene procedures for equipment, utensils and surfaces; environmental sampling; food allergen controls; supplier verification.

Bibliography

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
http://www.foodsafety.unl.edu/haccp/start/gettingstarted.html

Buchanan RL. Understanding and Managing Food Safety Risks. Food Safety Magazine, Dec 2010-Jan 2011.
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. US Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition. 2006

WHO. About risk analysis in food.
www.who.int/foodsafety/risk-analysis/en/

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