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Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to the identification, assessment, and control of hazards in commercial food production.26 It is widely recognized by several organizations such as the World Health Organization (WHO), the Codex Alimentarius Commission, and the Food and Agriculture Organization of the United Nations (FAO) as an effective food safety system to establish good production, sanitation, and manufacturing practices in the food industry.26, 13, 36, 7 HACCP is a preventive system rather than an inspection system which includes procedures to limit problems before their occurrence. It integrates food safety control into the process design and is accepted as a more efficient and cost-effective system than the conventional end-product testing for the production of safe foods.13, 36, 42
HACCP was developed in 1959 by the Pillsbury Company, in collaboration with the National Aeronautics and Space Administration (NASA) to ensure safety of food produced for the United States (U.S.) space program.42, 26 Since then, HACCP has grown to become the universally recognized and accepted method for food safety assurance.44 In 1992, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) approved HACCP as an effective and logical system of food safety assurance and published the framework of the present HACCP system.19, 34
HACCP was originally developed to prevent microbiological hazards in foods, but over the period of time it has been broadened to include physical and chemical hazards.
The growing concerns about food safety from public health authorities, food industry, and consumers, as well as the significant increase in the incidence of foodborne diseases have driven the application of HACCP systems worldwide.44 It has been included in the national food safety legislations of many countries, including U.S., Canada, European Union (EU), Australia and New Zealand, and is recognized as the most effective and economical system to reduce foodborne diseases.26, 23
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HACCP systems are based on the seven principles developed by the NACMCF.13 These principles are widely accepted and must be followed to prepare an effective HACCP plan.11 These seven principles are:
- Conduct a Hazard Analysis -- This principle includes the identification of hazards associated with the food product. The hazard assessment involves three main steps:36, 13
- Preparing a flow diagram that depicts food production steps from receipt to sale.
- Listing the steps in the process where significant hazards may occur.
- Developing preventive measures that the plant can implement to control the hazards.
There are three types of hazards that may be associated with foods:11
i) Biological -- includes bacterial, viral, and parasitic organisms that cause foodborne illness, and are frequently associated with humans and with raw food products that enter the food plant.
Examples: Clostridium botulinum, Salmonella typhi, Trichinella spiralis
ii) Chemical -- includes naturally occurring and added chemicals that may cause chronic illness at lower levels.
Examples: Aflatoxins, ciguatoxin, pesticides, food additives.
iii) Physical -- includes hard foreign objects that may pose potential physical risks, and results from contamination and poor practices either inside or outside the food plant.
Examples: Stones, metal fragments, plastic, glass fixtures
- Identify Critical Control Points -- This principle includes the identification of critical control points (CCPs), the central feature of HACCP analysis.22 A CCP is defined as a point, step, or procedure in the food chain at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.13 All CCPs must be carefully analyzed and documented.19 CCPs in food preparation may include:
- Cooking
- Chilling
- Specific sanitation procedures
- Product formulation control
- Employee and environmental hygiene
- Establish Critical Limits for Each CCP -- This principle includes the development of critical limits for each CCP. A critical limit is defined as a criterion that must be met for each preventive measure associated with a CCP. Critical limits may be derived from various sources which include: 11
- Regulatory standards and guidelines
- Scientific literature
- Experimental studies
- Consultation with experts
Each CCP will have one or more preventive measures for which critical limits must be established and controlled for prevention, elimination, or reduction of hazards to an acceptable limit. Some process parameters which are frequently used for critical limits include:11, 19
- Time
- Temperature
- Physical dimensions
- Humidity
- Water activity
- pH
- Salt concentration
- Moisture content
- Establish Procedures to Monitor Each CCP -- This principle includes the development of procedures to monitor CCPs and use monitoring results to adjust and control processes. Monitoring mainly consists of observations and measurements taken to determine that a CCP is properly controlled. There are three main purposes for monitoring:11
- Tracks the system’s operation so that a loss of control can be recognized and corrective action can be taken to regain control of the process before a deviation occurs.
- Indicates when a loss of control and a deviation have actually occurred, and corrective action must be taken.
- Provides written documentation to verify the HACCP plan.
The best way of monitoring CCPs is by the use of indicators, whenever possible, which provide a more cost-effective approach to control than product sampling and testing which is more expensive and may not provide timely results.36 For example time-temperature indicators are commonly used in the cook-chill operations in the food plant.
- Establish Corrective Actions -- This principle includes the implementation of corrective actions when monitoring indicates a deviation from an established critical limit. This ensures that no unsafe product enters commerce as a result of deviation.13 NACMCF emphasizes that the corrective action plan must always be in place to:11, 19
- Determine the disposition of the noncompliant product
- Identify and correct the cause of deviation to regain control of the CCP
- Maintain records of corrective actions
- Establish Record Keeping Procedures -- This principle establishes effective record keeping systems that document the HACCP system. NACMCF states that a food establishment’s HACCP plan and associated records must be maintained on file at the establishment. Some examples of records at different points of food production include:11
- Ingredients -- Supplier certification, storage temperature and time
- Preparation -- Monitored CCPs, adequacy of procedures
- Packaging -- Specification of packaging materials and sealing
- Finished Product -- Product safety and shelf life data
- Storage and Distribution -- Temperature records
- Deviation and Corrective Action -- Validation records
- Establish Procedures for Verifying the HACCP System is Working as Intended -- This principle verifies if the HACCP system is in compliance with the plan or whether the plan needs modification or revalidation. NACMCF has identified four steps in the verification of the HACCP system for a food establishment. These steps include:19
- Scientific and technical processes to verify that all critical limits for CCPs are adequate to control possible hazards.
- Assurance of proper functioning of HACCP plan through frequent review of the plan, verification, review of records, and determination that occurrence of deviations will result in appropriate decisions and product dispositions.
- Documentation through periodic review to ensure the accuracy of the HACCP plan, including an on-site review and verification of all flow diagrams, CCPs, critical limits, monitoring procedures, corrective actions, and records.
- Regulatory verification to ensure that the plan is working satisfactorily through complete validation of the process and final product testing to ensure that regulatory and quality standards are in compliance.
For additional information on HACCP principles, please visit FDA -- 1997 Food Code : HACCP Guidelines.
Application of HACCP Principles
The HACCP principles may be applied throughout the food chain from harvest to consumption by small independents as well as national and regional companies. It may also be incorporated into the formulations and standard operating procedures of any plant size.11 Some of the ways HACCP principles are applied include:42
- Used as a method of food safety assurance in food production, processing, manufacturing, and preparation.
- Used as a method of effective food control that allows more efficient inspection of food operations, and confirms the design accuracy and appropriate work efficiency of the process.
- Used to study food preparation practices, and to identify and analyze possible hazards, which should be the focus of health education interventions.
- Used in the management of overall food safety programs to identify problems which pose greatest risk to the public health.
For additional information on application of HACCP principles, please view the publication entitled FAO/WHO guidance to governments on the application of HACCP in small and/or less-developed food businesses.
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Training and education are critical for successful HACCP implementation, providing the HACCP teams, managers, operators, and food handlers with the additional technical skills required to implement HACCP. A survey has shown that the use of HACCP and proper implementation of the seven principles was found to be significantly higher in businesses with qualified and trained managers than in businesses without any formal-trained managers.24 Overall, HACCP training is important for:23
- Effective implementation of the HACCP system by the food industry
- Optimum use of HACCP data by the regulatory agencies
- Complete realization of HACCP benefits by the food industry, the regulatory agencies and the general public
Objectives of HACCP Training
The common objective of HACCP training should be to develop and promote the understanding and application of HACCP principles to produce safe food. There are three specific objectives of HACCP training. These objectives are:23
- To impart an understanding of the practical implications of HACCP to the food safety
- To impart practical expertise and knowledge for HACCP application
- To provide the motivation for further development and managemnet of HACCP
The groups of people which should receive HACCP training include:23
- Food regulatory and inspection personnel
- Senior management of food manufacturing companies
- Persons carrying out HACCP studies
- Persons implementing HACCP evaluations
Different groups of people will require different HACCP training depending on their level of technical expertise and their role in imparting food safety in the overall HACCP process.24, 7 For example, food regulatory personnel need training focused on practical skills while regulatory and inspection personnel, and senior management in food establishments require training centered on HACCP principles.23
Implementation of HACCP Training
Successful training in the practical aspects of the HACCP system require a well coordinated training plan that can deliver information from one level of individuals to the other. It requires a basic understanding of HACCP principles which can be achieved by attendance at courses, and particularly, requires experience in practical application of the HACCP system. Training focused on HACCP principles and applications should include professionally prepared information presented in a clear authoritative way by an individual already experienced in HACCP application.23
HACCP training is particularly important for a small company which has limited access to information and has a time constraint or inadequate skills to understand the HACCP system.29 The worldwide interest in HACCP applications has greatly increased the demand for HACCP training, particularly in developing countries. WHO and FAO have made several recommendations and published manuals of HACCP training for both developed and developing nations. In addition, these organizations also offer HACCP training programs.23, 2
For information on HACCP training course offered by FAO, please visit HACCP Training Program developed by the Food Quality and Standards Service.
For information on the HACCP training manual published by WHO and Industry Council for Development, please visit HACCP Principles and Practice – Teacher’s Handbook.
For information on the training manual on food hygiene and the HACCP system published by FAO, please visit Food Quality and Safety Systems - A Training Manual on Food Hygiene and the Hazard Analysis and Critical Control Point (HACCP) System.
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The format of a HACCP plan may vary according to the product and process. All plans should consider each specific operation separately to focus control at CCPs.7, 3 There are twelve tasks required to develop a HACCP plan and these must be designed to ensure that the seven principles will be applied accurately.5 The accomplishment of five preliminary tasks before the application of the seven HACCP principles leads to better HACCP plan development.33 These preliminary steps include:
- Assemble HACCP Team -- This task comprises assembling a multidisciplinary team consisting of individuals with specific knowledge and skills appropriate to the product and process.20, 7 The team should include one HACCP-trained person. This person need not to be a company employee, but should be available for plan development and certain functions, like re-evaluating the HACCP plan.33 If HACCP team members are not available on-site, then resources should be obtained from outside the company. However, complete reliance on outside resources is not recommended as it may limit the support of plant personnel.3 The HACCP team should include:5
- A team leader to direct the work of the group ensuring that the concept is applied correctly.
- A specialist with a detailed knowledge of the commodity system who will be responsible for the preparation of commodity flow diagrams.
- Several specialists, each with an understanding of particular hazards and associated risks. These may include:
- Microbiologist
- Chemist
- Mycotoxicologist
- Toxicologist
- Quality Assurance Manager
- Process Engineer
- Environment Specialist
- Other resources, such as raw material suppliers, packaging specialists, distribution and production staff, who are knowledgeable about the process and may serve as temporary team members that provide relevant expertise.
- A technical secretary to record team’s progress and results of the analysis.
The primary objective of the HACCP team is to identify the scope of the HACCP plan. This determines which segment of the food chain is involved in the complete process and general types of hazards to be addressed.
- Describe the Product and Its Distribution -- This task includes preparation of the complete product description by the HACCP team, including its method of production, distribution, and customer specification. This helps the team to identify actual hazards associated with the process. The description should include the following information:7, 5
- Safety (e.g. mycotoxin regulations/target level)
- Composition
- Physical and chemical properties of the raw materials and final product
- Water activity
- pH
- Type of packaging to be used
- Storage and transportation conditions
- Shelf life and recommended storage temperatures
- Labeling information
- Method and temperature of distribution
- Identify the Product’s Intended Use -- This step describes the normal expected use of the product which is useful in hazard analysis. This contains information whether the product will be consumed directly, or cooked, or further processed. In some cases, the nature of the target group is also important, particularly if it includes susceptible populations such as infants, the elderly, malnourished, and immune-compromised. The possibility of misuse of a product should also be considered, such as the use of pet food as human food, either by accident or design.7, 5
- Develop a Commodity Flow Diagram -- This step includes development of a process flow diagram which provides a clear and simple outline of the steps involved in the process. The diagram should include all the process steps in detail which are directly under the control of the company. If relevant, it should also include steps in the food chain which are before and after the processing. Data in the flow diagram may include:3
- All ingredients and packaging used (biological, chemical, physical data)
- Sequence of all process operations (including raw material addition)
- Time/temperature history of all raw materials, intermediate, and final products
- Flow conditions for liquid and solids
- Product recycle/rework loops
- Equipment design features
In addition, a simple layout of the facility and equipment is often useful to understand and evaluate product and process flow as well as employee traffic.7 The layout may include:3
- Personnel routes
- Routes of potential cross-contamination
- Segregation area
- Flow of ingredients and packaging materials
- Location of changing rooms, washrooms, lunchrooms, and hand-washing stations
- On-Site Confirmation of Flow Diagram -- This step includes the verification of the accuracy and completeness of the flow diagram by the HACCP team through an on-site review of the process.7 The on-site review process is known as walking the line, a step by step process to check that all relevant information has been considered in the flow diagram. If required, the following information should be included in the diagram:5
- Time of harvest
- Drying procedures
- Storage conditions
- Marketing chain
- Socio-economic factors
- Grading systems
- Processing systems
On the completion of five preliminary steps, the seven HACCP principles are applied by the HACCP team described under the section Principles of HACCP.
For additional guidelines on developing a HACCP Plan, please visit FAO -- The Hazard Analysis and Critical Control Point (HACCP) System.
Implementation and Maintenance of the HACCP Plan
HACCP implementation by food organizations greatly enhances their role in food safety, thereby conferring better protection than the conventional food safety procedures.7 The successful implementation of HACCP is facilitated by the full commitment and involvement of management and the workforce.42 It is a team assignment as no individual is likely to possess all the required practical, technical, theoretical, and managerial skills.26 The HACCP team should be adequately trained for developing the initial plan and coordinating its implementation. The continual application of monitoring, record-keeping, and corrective action procedures are important aspects to execute the HACCP plan and employees responsible for these activities should be trained accordingly.7 The plan should be developed within the constraints of the available resources and achievable time scales, with the focus to attain maximum benefits using minimum costs.42
Maintenance of an effective HACCP system depends mainly on verification activities which are scheduled periodically. As required, the plan should be updated and revised to ensure that it will result in the control of hazards. Training of all individuals involved in the plan is an important aspect of HACCP maintenance. It is critical that all personnel understand their role and can effectively implement their responsibilities to apply HACCP as an effective food safety system.7
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HACCP has gained
worldwide acceptance as the preferred preventive approach for assuring safe food production.
Currently the food industry, including foodservice operations, supports its application as
the best system available to limit and prevent foodborne illness.35 In addition, it is widely
recognized as the most cost-effective system to control foodborne hazards in all segments of
the food industry from farm-to-table.25 It is intended for use by food companies (i.e. food
producers, manufacturers, distributors, and retailers) as a procedure to develop unique food
safety assurance system, and to meet their specific needs.26
In the U.S., HACCP was first introduced in 1973 by joint
industry/government regulatory program to control botulism in
low-acid canned foods.19, 21 Since then new challenges in the U.S.
food supply, particularly emerging foodborne pathogens, have prompted the food industry to
implement HACCP on a
wider basis to prevent unsafe food from reaching consumers. Today several food companies,
including meat, poultry, seafood, and juice, apply HACCP system in their manufacturing processes to ensure
their product safety.12 A 2008 survey revealed that 35 percent of plants have had a HACCP plan in place for the
past 6-10 years, while 18 percent have had their HACCP plan in place within the last five years, and 86
percent have revised their plants’ plan within the last year. Several factors have motivated
food manufacturers to implement HACCP in their facilities. Some of these factors include:12, 41
- Requirement for a preventive system to ensure food safety
- Adhering to government regulations
- Prioritizing potential hazards
- Increasing public concern about contamination
- Improving potential for international trade
The NACMCF has indicated that HACCP has been evolving over the years to now include both
nationally and internationally recognized General Principles and Guidelines for its
Application in food manufacturing systems.21 Several international organizations, including
the International Commission on Microbiological Specifications for Foods (ICMSF), and the
International Association of Milk, Food, and Environmental Sanitarians (IAMFES), have
recommended the broad application of HACCP to ensure food safety.3
Prerequisite Programs
The development and implementation of a successful HACCP system in food establishments are based upon certain
prerequisite programs. Prerequisite programs include the basic environmental and operating
conditions that are essential for the production of safe and wholesome foods. A company may
opt to utilize an existing system or set up auditing teams to evaluate prerequisite programs
in conjunction with HACCP implementation.28 Some examples of prerequisite programs and practices
include:27
- Good Manufacturing Practices (GMPs) -- Every food plant should develop
GMPs based on its specific
operation. GMPs must be followed by
all employees, including management and maintenance employees as well as all visitors.
- Good Agricultural Practices (GAPs) -- Food handling facilities should
require their suppliers to follow GAPs for raw agricultural commodities as described in the FDA/USDA guidelines.
- Standard Operating Procedures (SOPs) -- An effective HACCP system is not possible in
lack of well-visualized, well-written, and properly implemented SOPs. SOPs must be specific for each function in the facility and should be
written in a useable and stepwise format which shall be monitored and documented
periodically. They should provide sufficient details to be effectively understood and
applied by the employees. Some examples of specific functions for which SOPs may be developed and implemented
include:28
- Facilities and equipment
- Pre-start up inspection
- Specification systems
- Supplier/material control
- Cleaning procedures and sanitization
- Storage, shipping, and handling
- Chemical control
- Recall and material traceability
- Pest management
- Operator/employee training
- Calibration and standardization
- Environmental monitoring
- Allergen control
- Foreign material control
In addition, Sanitation Standard Operating Procedures (SSOPs) are required if the food
processing systems fall under federal HACCP regulations. For example, USDA/Food Safety and Inspection Service
(FSIS) HACCP
regulations require that meat and poultry plants develop, implement, and maintain SSOPs. SSOPs are discussed in detail in the next section HACCP Regulations in the Food Industry.
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The central role of HACCP regulations is to promote
improvement in food safety practices by setting public health-oriented targets or standards. All HACCP regulated plants must meet the standards set by the regulatory agencies
to minimize the risk from foodborne hazards and to achieve an acceptable level of product safety.19 In the U.S., HACCP is
regulated in the meat and poultry industry by the USDA
and in the seafood and juice industry by the FDA. Although each
regulatory agency has distinctive HACCP standards based on product risk consideration, all agencies have some common
components to regulate HACCP. These components include:21
- Consideration of GMPs and SSOPs as a prerequisite to
HACCP implementation.
- Implementation of general HACCP principles.
- Verification methods of industry development, implementation, and maintenance of effective HACCP systems.
- Establishment of performance standards.
- Engagement in programs for education and training.
- Research sponsorship to improve HACCP system
functionality.
Federally regulated plants are required to maintain, develop, and implement SSOPs within their facilities. SSOPs may include:27, 18
- Steps to minimize cross-contamination
- Maintenance of a potable water supply
- Specific practices to ensure the facility and equipment sanitation
The USDA/FSIS HACCP regulations require all
meat and poultry facilities to have written SSOPs in place. In addition, requirements for corrective actions, recordkeeping, and verification of SSOPs by FSIS
inspectors are also included in these regulations.21, 27 The FDA HACCP regulations for seafood and fruit juices require plants to
develop, implement, and maintain SSOPs . These SSOPs should contain, at minimum, the following
sanitation conditions:27
- Safety of water sources
- Cleanliness of food contact surfaces
- Prevention of cross-contamination
- Maintenance of hand washing and toilet facilities
- Protection from contamination
- Proper labeling, storage, and use of toxic materials
- Control of employee health
- Exclusion of pests
USDA/FSIS HACCP Regulations for Meat and Poultry Plants
The Centers for Disease Control and Prevention (CDC) estimates approximately 4,000 deaths and 5 million illnesses occur from
the consumption of contaminated meat and poultry. The main sources of contamination in these products are four foodborne
bacterial pathogens: Salmonella, Campylobacter, E. coli O157:H7, and Listeria
monocytogenes.32 In order to reduce and prevent these pathogens in meat and poultry products, USDA/FSIS
proposed regulations that were published in the final Pathogen Reduction/HACCP Systems Rule
(PR/HACCP Rule) on July 25, 1996.32, 19 The PR/HACCP rule defined the respective roles, tasks, and responsibilities of both FSIS and the industry, and held meat and poultry businesses accountable for their safety.21
The PR/HACCP regulations required that:31
- All meat and poultry establishments develop and implement HACCP system.
- All meat and poultry plants develop and implement written SSOPs.
- Slaughter establishments perform regular microbial testing to verify the adequacy of process controls for the prevention
and removal of fecal contamination and associated bacteria.
- Establishments which slaughter or produce raw ground meat or poultry products must meet Salmonella reduction
performance standards.
The final PR/HACCP rule went into effect
for large, small, and very small meat and poultry plants in the years 1998, 1999 and 2000, respectively. In 2000, HACCP was implemented in large and small meat and poultry
facilities which produce 90 percent of raw meat and poultry, and 55 percent of processed products such as frozen dinners,
frankfurters, or hams.21 Currently, FSIS inspectors have
implemented the HACCP system in over 6,500 U.S. raw meat and poultry plants.18 FSIS has determined that HACCP provides assurance and documentation to control meat and poultry manufacturing processes thereby producing safe, wholesome, and unadulterated products.19
For additional information on USDA/FSIS Pathogen reduction and HACCP system, please visit FSIS -- HACCP and Pathogen Reduction.
FDA HACCP Regulations for Fruit and Vegetable Juices
Several juice products were implicated in foodborne disease outbreaks in the 1990s due to contamination with bacterial
pathogens, including Salmonella and E. coli O157:H7. This led to an increased focus on juice safety
measures to reduce the risks associated with these pathogens. In order to minimize food safety risks in the juice processing,
packaging, and transportation industries, the FDA proposed Juice
HACCP regulations which were published in the final Juice HACCP Rule on January 19, 2001.17, 8
The final rule went into effect for large and medium businesses in 2002, for small businesses in 2003, and for very small
businesses in 2004. FDA juice regulations require juice processors to
evaluate processing operations using HACCP principles,
and if necessary, to develop and implement the HACCP
system for these operations which do not include:9
- Harvesting, picking, or transporting raw agricultural ingredients for juice processing.
- Operations of retail establishments or businesses that make and sell juice directly to consumers.
According to the Juice HACCP regulations, both
interstate and intrastate processors must comply with specific requirements. Some of these requirements include:9, 17
- Maintain the HACCP plan and other records of SSOPs
and HACCP operations.
- Train employees involved in developing and implementing the HACCP plan.
- Reduce a theoretical population of a pertinent microorganism, the most resistant microorganism of public health
significance, in the juice by 99.999 percent or 5-log cycles.
- Bear a warning label on juice that has not been treated to achieve a 5-log reduction in the most resistant pathogen.
- Follow Current Good Manufacturing Practices (cGMPs).
In addition, Juice HACCP regulations also specify
requirements for imported juice. The juice importers must comply with one of the following requirements:9
- Ensure that all juice imported by them has been processed in compliance with the Juice HACCP regulations.
- Import juice from a country that has an appropriate memorandum of understanding (MOU) with the U.S. that covers juice inspection and the inspection documents in equivalence or compliance with the U.S. system.
For additional information on FDA Juice HACCP Regulations, please visit FDA -- Guidance for Industry: Juice HACCP Hazards and Control Guidance First Edition.
FDA HACCP Regulations for Seafood
Ensuring the safety of seafood (fish and fishery products) presents constant challenges to the seafood industry and
regulatory agencies such as:6
- Seafood consists of hundreds of edible species around the world which are prone to a wide range of hazards before
harvest. Some of these hazards include:
- Bacteria
- Viruses
- Toxic chemicals
- Natural toxins
- Parasites
- Seafood is harvested under difficult conditions and at varying distances from processing, transport, and retail
facilities.
- Seafood is imported in higher quantities in the U.S. than any other flesh food.
Over 55 percent of seafood consumed in the U.S. is imported from approximately 135
countries.
In order to ensure the safe and sanitary processing of seafood, including imported seafood, the FDA proposed HACCP regulations which were published in the final Seafood HACCP Rule on December 18, 1995.6 Besides maintaining a documented HACCP plan, Seafood HACCP regulations require the seafood
processors and importers to comply with certain prerequisite programs which include:28
- cGMPs
- SSOPs
- Monitoring and recordkeeping of sanitation control points
According to seafood HACCP regulations, eight
sanitation control points within safety assurance procedures are required to be monitored and recorded. These eight control
points are:26
- Safety of water that comes into contact with food and food-contact surfaces, or is used in the manufacture of ice.
- Cleanliness and condition of food-contact surfaces, utensils, gloves, and outer clothing.
- Prevention of cross-contamination from unhygienic object to food-contact surfaces, utensils, gloves, and outer clothing,
and from raw food to cooked food.
- Maintenance of hand washing, sanitizing, and toilet facilities.
- Protection of food, packaging material, and food-contact surfaces from contamination by lubricants, fuel, pesticides,
cleansers, sanitizers, condensates, and other hazards.
- Proper labeling, storage, and use of toxic chemicals.
- Check and control on employee health conditions.
- Pest exclusion from food production, processing, and handling sites.
Seafood HACCP regulations also specify requirements for
imported seafood. The seafood importers must comply with one of the following requirements:10
- Import products from a country that has an active equivalence or compliance agreement with FDA covering fish and fishery products.
- Ensure that all seafood imported by them has been processed in compliance with the Seafood HACCP regulations.
For additional information on the HACCP regulations for
fish and fishery product imports, and foreign processors approved by their governments, please visit FDA/CFSAN -- Fish and Fishery Product Imports: Affirmative
Steps.
For additional information on the Seafood HACCP plan and regulations, please visit FDA -- Fish and Fisheries Products Hazards and Controls Guidance.
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HACCP is an effective
tool for safe food production which confers economic benefits to the food companies, the
society, and the government.4 However, the effective implementation of HACCP requires
investments. The Food and Nutrition division of the FAO has identified some costs required for the
development of HACCP
systems. These costs are needed for:24
- Initial development of the HACCP plan
- Monitoring and recordkeeping
- Training
- Inspection of HACCP implementation and operations
- Monitoring equipments
- Corrective actions
- Consulting and auditing
The costs associated with HACCP have lead to its limited use in small companies.29 While big companies
have an easy access to resources and technical assistance, small firms lack appropriate
resources and technical expertise to implement HACCP. This leads to a lesser possibility for a small company to have HACCP in place.24
Industry surveys and some studies in the United Kingdom and Europe have indicated that small
food firms are less likely to invest in hygiene, food safety, and HACCP than the larger companies. Small
companies prefer to invest more in processes that are directly related to production than in
the food safety.24, 29 Thus, HACCP presents a financial load on small companies, and these companies
rely on government or other agencies for external help at minimal cost.24
HACCP cost
requirements have raised certain cost concerns among industry, government, and consumers.
The main concerns are:4
- Whether the HACCP benefits are grater than its costs.
- Whether the benefits to the firm are greater than the costs incurred for implementing
HACCP.
- Whether the cost of implementing and maintaining HACCP shall be a part of the cost to consumers.
The usefulness of HACCP should be evaluated to determine if the costs associated with
implementing HACCP are
less than the expense of the benefits offered by it. HACCP systems should reduce costs of raw material
inspection, materials specification, raw materials inventory and other input costs.
Appropriate awareness of HACCP systems among suppliers and processors, and transmission of its
requirements to customers or suppliers can reduce marketing and sales costs. Although there
is limited data available on cost-benefit analysis of HACCP, it has been suggested that proper HACCP planning will lead to
minimal investments, particularly to reduce foodborne diseases.4, 43 It overcomes the high costs
of setting and enforcing standards for microbial foodborne pathogens. However, no evidence
is available regarding the actual risk reduction from applying HACCP to the whole industry or a part of the
food production. In the U.S., the potential
benefits of HACCP
offset its costs, but the extent in which HACCP really improves food safety remains unanswered.36
Other Implications
Besides economic implications, there are other factors which can limit the use of HACCP in small businesses in
developed countries. Some of these factors include:
- Resistance to Change -- Adoption of HACCP requires a shift in approach from conventional
inspection methods to a HACCP-based inspection. The small company managers believe that they are
already producing safe foods, and thus have little motivation towards this transition.
Legislation is the only force that has driven these companies to apply HACCP within their processing
systems.43, 29
- Lack of Expertise -- A small business, without in-house technical
support, requires substantial training of employees and an expert help to develop,
implement, and manage the system within limited resources. However, the time and money
requirement for HACCP
training and development is the main limiting factor in small firms.29, 4
- Difficulties in Documentation and Verification -- Verbal communication
plays a main role in the successful management of small businesses. Any HACCP-associated paperwork or
documentation is a burden for small companies. In addition, the technical expertise and
costs associated with the documentation and periodic verification of the HACCP system is a limitation
for most small businesses.29
Implications as an International Trade Standard
HACCP is a food safety
regulatory standard used by importing and exporting countries to facilitate trade in the
international market. It plays a vital role for food safety and trade worldwide. However,
there are certain implications regarding the use of HACCP for international trading.24 These implications
include:
- Different types of HACCP programs exist representing the diversity of industries, countries,
and people managing the food safety. In this case, some level of equivalence is required
between two different HACCP plans that can relate to a common measurable food safety objective.24
- The large food processors in developing countries are the main exporters for developed
countries. They may lack technical resources to validate HACCP plans at the plant level. In addition, they have
very limited supply of native language HACCP documents and are dependent on English-speaking employees.24, 26
- Not all countries are legally authorized to move to the HACCP-based inspection system. In some countries,
governments may have limited resources to verify HACCP at plant level.43, 24
- Importing countries require application of HACCP principles by exporting countries for the food intended for
export. This may create significant trade barriers for the countries that are unable to meet
these requirements due to insufficient resources or lack of technical expertise.2
According to FAO, "The application of HACCP as a trade policy requires a definition of the role of government in the utilization of the HACCP process. Exporting countries may require additional resources to meet
the HACCP
requirements. Adequate measures should be taken to enhance food trade, such as assessment of
food safety, training of personnel, technology transfer and strengthening of the national
food control system."
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The USDA Agricultural Research Service (ARS) is
actively involved in the research focusing on food safety enhancement in meat and poultry industries through the application of HACCP . The HACCP food safety research at the ARS is mainly coordinated through the National Food Safety Program 108.
This research program provides the means to ensure that the food supply is safe and secure for consumers and that food and
feed meet foreign and domestic regulatory requirements. The following ARS research units conduct research on HACCP:
Some of the HACCP research projects being conducted at
the ARS research units are:
HACCP Assistance for Small and
Very Small Meat processors: Challenge Studies and Predictive Modeling for Validation of Critical Limits
Location: Microbial Food Safety
Research Unit
Project Objectives39
- Meet critical limit validation needs of meat and poultry processors by performing lab and pilot plant-based challenge
studies.
- Provide challenge study validation of computer-generated predictive models of pathogen growth in meat and poultry
products.
- Develop computer-generated predictive models of pathogen growth in meat and poultry products.
- Develop outreach materials that widely disseminate the results of challenge studies and predictive models to various
groups: to meat and poultry processors for use in validation and verification of HACCP plans, to industry groups and extension specialists for use in training and to state and
federal regulators.
Accomplishments39
- Released THERM v. 2 predictive tool on the website http://meathaccp.wisc.edu/. This tool allows the user to enter a
time/temperature history for a particular situation involving raw meat or poultry, and obtain a prediction of whether E.
coli O157:H7, Salmonella, or Staphylococcus aureus would grow.
- Obtained anecdotal evidence that processors throughout the U.S., as well as the occasional users in Europe and South
America, have used THERM v. 2 to deal with process deviations involving short-term temperature abuse of raw meats and
poultry.
HACCP Assistance for Small and Very Small Processors with Development and Validation of
Meat Chilling Rates
Location: Microbial Food Safety
Research Unit
Project Objectives40
- Develop mathematical models to describe meat and meat products chilling rates and integrate them with predictive models
for growth of pathogens.
Accomplishments40
- Conducted studies to model the effect of temperatures on growth of Salmonella in beef and chicken at various temperatures
ranging from 5oC to 50oC.
- Developed two predictive models applicable to the chilling of meat animal carcasses which will be incorporated in the
ARS-Pathogen Modeling Program.
HACCP Training and Research to Assist Meat Processors with Process Deviations for
Lethality and Stabilization
Location: Microbial Food Safety
Research Unit
Project Objectives38
- Develop and validate predictive models during cooking and cooling of cooked products.
- Incorporate these models into U.S. for extension meat specialists and for class room settings HACCP courses offered by land grant universities.
Accomplishments38
- Conducted studies to determine the growth of Clostridium perfringens in 75 percent lean beef, pork and poultry
at various temperatures ranging from 10oC to 50oC.
- Completed data collection and developed predictive models for the disposition of products subjected to cooling
deviations.
- Planned to incorporate these models in the ARS-Pathogen Modeling Program.
Engineering Innovations and
Micro Developments to Reduce Contamination of Poultry and Equipment
Location: Richard B. Russell Agricultural Research Center
Project Objectives37
- Develop basic information on the role of the feather and feather follicle on the micro of broilers.
- Verify models for bacterial movement in commercial scalders.
- Develop intervention strategies that may be incorporated into a ARS plan to reduce aerosols and water usage.
- Determine efficacy of GRAS status antimicrobials as alternatives.
Accomplishments37
- Conducted a survey of all broiler processing facilities across the U.S.
to determine the amount of water being used during processing, where the water is being used, how much water is being
recycled and the application location and types of antimicrobial treatments.
- Showed an increase in water usage associated with HACCP implementation, as well as a significant relationship between the size of bird processed and the
average amount of water used to process each broiler.
- This research will be used to assist broiler processing facilities with water conservation and recycling efforts.
ARS Research Publications
In response to the emerging needs of the regulatory agencies and industry to implement the HACCP-based inspection system,
ARS researchers are constantly working to develop new methodologies
and automated on-line inspection systems for efficient and non-destructive carcass inspection and detection of fecal
contamination. The following list of publications demonstrates some examples of new methodologies for carcass inspection
developed by the ARS scientists.
- Analysis of
Vis/NIR Spectral Variations of Wholesome, Septicemia, and Cadaver Chicken Samples.
- Fluorescence
Characteristics of Wholesome and Unwholesome Chicken Carcasses.
- Development of
Multispectral Image Processing Algorithms for Identification of Wholesome, Septicemic, and Inflammatory Process Chickens.
- Uses of
Hyperspectral and Multispectral Laser Induced Fluorescence Imaging Techniques for Food Safety Inspection.
Additional USDA Projects and Surveys
Following the publication of the final PR/HACCP rule in 1996,
the USDA FSIS introduced the HACCP-Based Inspection Models Project (HIMP) to improve food safety of the U.S. meat and poultry supply. In addition, USDA Economic Research Service (ERS) conducted surveys about food safety
technologies and PR/HACCP compliance. A brief description of HIMP and economic surveys is given below.
HACCP-Based Inspection Models Project (HIMP)
The HIMP was developed by the FSIS to develop a flexible, more efficient, and completely integrated meat and poultry inspection system.15 It facilitates FSIS to improve the use of
its online slaughter inspectors, and to ensure the reduction and/or elimination of defects that are not detected by the
traditional inspection system.14 The primary objectives of this project are to:15
- Maintain and enhance the food safety and other consumer protection benefits of the current carcass inspection system.
- Effectively and efficiently oversee, evaluate, and verify industry implementation of the PR/HACCP regulations.
Under this project, FSIS has developed three slaughter models
or the selected animal classes. These animal classes include:14
- Young poultry (including turkeys)
- Market hogs
- Fed cattle (steers/heifers)
The project applies only to plants that slaughter these classes of healthy and young animals. The models describe the
baseline data collection phase and steps in the project that will ensure that the new system will perform in a manner
equivalent to the traditional system.14 The participating plant is required to modify its HACCP plan to include at least one CCP
associated with food safety diseases and conditions. In addition, each plant should develop a process control plan to address non-food safety consumer protection concerns, such as removing bruises.15 In April 2007, twenty young chicken plants, five market hog plants, and two young turkey plants have participated in this model program.16
New roles for FSIS inspectors have also been developed. The
FSIS inspectors conduct inspection of each carcass with better
verification to ensure that performance standards are met. The inspectors also check for fecal contamination and other
organoleptic food safety defects four times more frequently under the models project than under the traditional system.14
For additional information on the HIMP study design, performance standards, inspection procedures, and list of participating
plants, please visit FSIS -- HACCP -Based Inspection Models Project (HIMP).
Food Safety Technologies and HACCP Compliance
Survey
In 2001, the ERS, in collaboration with Washington State University,
conducted two surveys about food safety technologies and PR/HACCP compliance. The main feature of one of these surveys was to
determine the effects of the PR/HACCP rule on plant operations and costs. The results of the survey indicated that industries and market have worked in
conjunction with regulations to promote the use of more advanced food safety technologies. The U.S. plants spent about $ 380 million annually and made $ 570 million in long-term investments to comply with the PR/HACCP regulation.1
For additional information on survey questions and responses, please visit ERS --
Food Safety Technologies and HACCP Compliance Survey.
FSRIO Research Projects Database
For additional USDA HACCP
Research Projects, please visit the FSRIO Research
Projects Database.
For additional HACCP research projects conducted by
other U.S. government and International agencies, please search the FSRIO Research Projects Database.
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