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article1.docxThe impact of food regulation on the food supply chain
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DOI: 10.1016/j.tox.2005.12.024
Abstract
Food regulation in the main is aimed at protecting the consumer's health, increasing economic viability, harmonizing well-being and engendering fair trade on foods within and between nations. Consumers nowadays are faced with food or food ingredients that may derive from distant countries or continents, and with a less transparent food supply. Safety concerns must cover the range of different food chains relevant to a certain food product or product group, including all relevant producers, manufacturing sites and food service establishments within a country as well as those importing into the country. Hazard analysis at critical control points (HACCP), good manufacturing practice (GMP) and good hygiene practice (GHP) are major components of the safety management systems in the food supply chain. Principally, “a hazard” is a biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect. The likelihood of occurrence and severity of the same is important for the assessment of the risk presented by the hazard to the food supply chain. The Government's regulatory mechanisms in accordance with the WTO agreements (HACCPs, sanitary and phytosanitary measures, etc.) oversee the analyses of public health problems and their association to the food supply. Under the WTO SPS Agreements and the codes of practices issued by the Codex Alimentarius Commission, there now exists a benchmark for international harmonization that guarantee the trade of safe food. Inevitably, food safety is still mainly the responsibility of the consumer.
Keywords
· HACCP;
· The World Trade Organization (WTO);
· Food regulation;
· Food safety and toxicology;
· Food supply chain;
· Risk assessment
1. The food supply chain and the World Trade Organization (WTO)
Food regulation in the main is aimed at protecting the consumer's health, increasing economic viability, harmonizing well-being and engendering fair trade on foods within and between nations.
Many factors that affect the food systems include the climate, available arable land, technology (from the standpoint of production, preservation, processing and storage). A modern food control program centers at all stages of the food supply chain, from farm to consumers ( Fig. 1 ). There is a need to balance the benefits of increased food supplies through technological processes against associated health and economic risks, a need that is of increasing importance given the rising trend in world population, the opening up of boundaries, migration, urbanization, and with these, changing food habits. Agricultural mechanization and industrial food processing advocated in Fig. 1 embrace that foods produced and presented to the markets have to meet standards that are universally acceptable. Thus, food legislation assures a safe supply of commodities and aspires to eliminate fraudulent practices. This is important given the diverse and changing trend of food commodities. Perishable food products such as meats, fish, vegetables, processed and packaged and ready to eat foods are finding their way across international boundaries and meeting competition with indigenous manufacturers.
Fig. 1.
The food supply chain. This has seen a continued trend in technological innovations from foods leaving the farm and their handling up until reaching the end user the consumer.
The World Trade Organization formed in 1995 is the only global international organization dealing with the rules of trade between nations. At its heart are the WTO agreements, negotiated and signed by the bulk of the world's trading nations and ratified in their parliaments. The goal is to help producers of goods and services, exporters and importers conduct their business ( Fig. 2 ). These agreements are the legal ground-rules for international commerce. Essentially, the agreements are contracts that guarantee member countries important trade rights and are there to help producers of goods and services, exporters and importers to conduct their business. The instruments also bind governments to keep their trade policies within agreed limits to everybody's benefit. Although the government's regulatory mechanisms oversees the analyses of public health problems and their association to the food supply, food safety is still mainly the responsibility of the consumer, they nevertheless need to be well informed.
Fig. 2.
The role of the WTO and international trade. The liberalization that has been achieved through GATT/WTO negotiations is especially noteworthy in light of the fact that negotiations occur through time between the governments of various countries. This feature raises the possibility that the market access implied by existing tariff commitments may be altered by tariff commitments made at some point in the future.
The activities of the WTO can be summarized as follows:
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administering trade agreements;
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acting as a forum for trade negotiations;
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settling trade disputes;
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reviewing national trade policies;
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assisting developing countries in trade policy issues through technical assistance and training;
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cooperating with other international organizations.
Whilst it is clear that developed countries monitor their food systems with the expected outcome in providing a consistent and constant supply of safe and wholesome food, many developing countries battle with an unsafe and inadequate food supply. This leads to heavy economic losses (particularly scarce foreign exchange) and health hazards ranging from malnutrition to food-borne illnesses. Interestingly, whilst economic globalization can easily equate with the expansion of international trade, it is clear that some developing countries continue to struggle to become fully integrated into the world trading system. It is critical therefore to improve awareness, simplify rules, improve skills and infrastructure, adapt food safety monitoring to local conditions, and help formulating risk management systems for niche products from developing countries ( Brown et al., 2002 , Anyanwu and Jukes, 1991 , Juke, 1988 , Jukes, 2000 and Henson and Loader, 2001 ; Schillhorn van Veen, 2005; Henson et al., 2005 ). As argued by Henson et al. (2005) , “there are concerns about power relations through the supply chain, supermarket demand for high-value fresh produce can provide opportunities for the enhancement of small-scale producer livelihoods” and at the same time, “attention has focused on the processes through which small-scale producers are integrated into, or excluded from, supermarket supply chains and the associated impact of stricter food safety and quality standards and logistics requirements”.
The confusion between quality and safety, over regulation, selective enforcement, lack of integration of food laws and regulations in the overall legislative system, the multiplicity of responsible agencies, and the mismatch between the required standards are among the major issues that the World Bank have come to realise. So poor economics, poor infrastructure and lagging skills have negative impact on trade for the developing countries. Improving food safety along the standards of the developed economies, however, may carry considerable costs and price food out of reach of the poor. Indeed improving awareness, simplifying rules, improving skills and infrastructure, adapting food safety monitoring to local conditions, and help in formulating management systems, e.g., HACCPs for niche products for developing countries are within the context of seeking harmonization in world trade.
Yapp and Fairman (2006) have reviewed the factors affecting food safety compliance within small and medium-sized enterprises (SMEs) and the implications for regulatory and enforcement strategies in the UK. The findings were quite remarkable. Among the identified factors were: lack of money (where SMEs focus on immediate survival rather than potential benefits derived over the long term) and lack of time. Time has tended to prevent the identification and interpretation of regulations, thereby preventing further action being taken by SMEs. More interesting however is the realization that food sector SMEs do not see these steps as part of their business operation. This was viewed as the duty of the external agencies such as the environmental health practitioners (EHPs) who inspect food businesses according to criteria contained within Code of Practice issued under Section 40 of the Act UK's Food Standards Agency. Yapp and Fairman argued that this reactive attitude rather than a lack of time prevents identification and interpretation of regulations by SMEs. Lack of experience, lack of access to information (seen as a problem with overprovision of information resulting in confusion about relevance), lack of support (where SMEs perceive that support is biased towards larger companies), lack of interest (where SMEs focus upon business survival rather than compliance with regulations) and lack of knowledge (where SMEs have poor awareness of the relevance of legislation) were noted. Quoting the work of Reiss (1984), Yapp and Fairman brought attention to the view that “The principal objective of a compliance law enforcement system is to secure conformity with the law by means of insuring compliance or by taking action to prevent potential law violations without the necessity to detect, process and penalize violators. The principal objective of deterrence law enforcement systems is to secure conformity with law by detecting violations of law, determining who is responsible for their violation, and penalizing violators to deter violations in the future”. It is clear that these considerations are not dissimilar from the experience of other SME in the world market.
The intent of the Global Agreement on Tariffs and Trade has been one of streamlining international trade. In the early phases of GATT, most attention was given to trade and trade conflicts between large trading blocks and markets such as the United States, European Community, Japan, etc. and too little to the interests of smaller developing countries. So the developing countries (or the less developed countries) have been left to adopt the rules that were specifically created for these large markets, and given little time to adjust their institutions to assure that export products are in compliance with, to them exotic, food safety rules. Thus, the introduction and application of food safety tools and rules need to be affordable and build on local food management customs rather than simply imposing standards that are expensive to monitor ( Henson et al., 2005 , Key and Runsten, 1999 and Nguz, in press ; Kroes and Walker, 2004; Chen, 2004 and Zepeda et al., 2001 ). Such an application has its benefit as Baker (2002) observed “a HACCP based food safety system that was integrated with restaurant policies, operations, documentation and communication strategies could have avoided the costly exercise of removing a highly profitable menu item, the associated loss of market momentum, heightened regulatory scrutiny and the potential to raise questions of consumer confidence.”
The WTO SPS Agreement relates to three main issues: food safety, animal health and plant health. In each case, the Agreement identifies an international body as providing the basic standards against which disputes over national regulations would be judged.
Under the WTO SPS Agreements and the codes of practices issued by the Codex Alimentarius Commission constitute the benchmark for international harmonization that guarantee the trade of safe food ( Jukes, 1993 , Jukes, 2000 and Boutrif, 2003 ). These need to be enacted and enforced in each country's food legislation.
The market access agenda in industrial countries extends to trade-impeding regulations such as environmental and health standards and restrictive rules of origin, as well as restrictions and regulations that limit the ability of developing countries to sell services abroad, especially through the temporary movement of workers ( World Bank, 2002 ; Schillhorn van Veen, 2003). It is clear that trade liberalization needs to be complemented by a number of other policies such as sound macroeconomic management, effective regulation (e.g., financial services), and improved customs and tax administration. This needs to embrace the policies and institutions to support social objectives and safeguard the interests of the poorest in society. Further, global trade rules need to be defined from a developmental perspective if they are to serve as tools for poverty reduction. In this context, capacity building measures should include bolstering the ability of stakeholders in developing countries to participate in the development and implementation of trade-related policies and global trading rules.
Compliance with the decision of the WTO remain an area of concern given the tendency of developed and powerful countries continuing to threaten the survival of the WTO system through lengthy and costly legal interpretations and appeals of dispute settlements without serious efforts by all parties to find win–win solutions. The most flagrant trade violations have been eliminated as a result of improved transparency in the process. Consumers are in general better off, since they have greater diversity and increased safety in what they can buy. The guidelines of the World Bank in its 2002 handbook on the magnitude of border barriers and trade liberalization upon which the foregoing comments were based, can be summarized as seeking to foster:
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effective market access that has a wider dimension than border restrictions on goods;
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reciprocal liberalization for developing countries that achieves improved access to markets abroad and greater openness at home, but there are major political economy constraints to be overcome;
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trade liberalization to form only a small part of the comprehensive domestic reforms that are needed to deliver poverty-reducing growth;
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better analysis of the costs and benefits of global trade rules for developing countries;
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integrating developing countries more effectively into the global economy.
2. Sanitary and Phytosanitary Agreements
Global harmonization of food safety regulations will undoubtedly help to ensure fair competition among countries in terms of trade and at the same time it will enable all populations enjoy the same degree of food safety. This was one of the ideas behind the Uruguay Round of Multilateral Trade Negotiations, which resulted in the creation of the WTO in 1995, including a number of agreements, e.g., the Agreement on the Application of SPS and the Agreement on Technical Barriers to Trade (TBT).
The Agreement on the Application of Sanitary and Phytosanitary Measures (the “SPS Agreement”) came into force with the formation of the World Trade Organization (WTO, 1995) . The SPS agreement was aimed at controlling issues affecting food safety measures. Although some constraints had been applied by the original General Agreement on Tariffs and Trade (GATT) in 1947, under Article XX(b), it was believed that various countries were using food safety concerns to justify, maintaining or erecting food regulations against imported foods which were a barrier to trade. One major qualification is contained in Article 3(3) of the SPS Agreement which states that: “members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a member determines to be appropriate in accordance with the relevant provisions…”. To help with interpretation, the term ‘scientific justification’ was further defined as follows: “there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this agreement, a member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.”
The term “sanitary or phytosanitary measure” is defined as any measure applied to protect human, animal, or plant life or health from certain risks, including risks arising from: (i) the spread of pests, diseases, disease-carrying organisms or disease-causing organisms, (ii) the presence of additives, contaminants, toxins or disease-causing organisms in foods, beverages or feeds and (iii) diseases carried by animals, plants or products thereof. The SPS Agreement, therefore, includes a broad scope of activities related to food safety as well as the protection of animal and plant health. As such, the SPS Agreement applies to all sanitary and phytosanitary measures that may affect international trade. Exporters must meet the quality and safety demanded by import market consumers. For this reason, international trading rules are in place in order to ensure that public standards are applied fairly and equally to domestic and imported products. WTO members supported the following SPS principles ( WTO, 1999 ):
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transparency;
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equivalence;
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harmonization;
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science-based measures;
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regionalization;
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national sovereignty;
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dispute resolution.
Hence, nations are required to publish their regulations and provide a mechanism for answering questions from trading partners. Member nations must accept that SPS measures of another country are equivalent if they result in the same level of public health protection, even if the measures themselves differ. The same level of health protection should apply to both domestic and imported products. Regulations should be such that they cannot impose requirements that do not have a scientific basis for reducing risk. The concept of pest- or disease-free areas within an exporting country is recognized. Exports can be allowed from such areas, even if other areas of an exporting country still have the disease or pest. Countries may choose a risk standard that differs from the international standard. This recognizes that individual nations are unwilling to subscribe to uniform international standards for all hazards. There is a clearly defined mechanism for resolving disputes between countries in a timely manner. The dispute settlement panel is expected only to state whether the SPS measures under question have a scientific basis and are consistently applied. Further, Member nations recognize the desirability of common SPS measures.
Three international organizations are recognized as sources of internationally agreed-upon standards: (1) The Codex Alimentarius Commission (Codex), (2) The International Office of Epizootics (OIE) and (3) The International Plant Protection Convention (IPPC). Brief comments on the first of these follow. The Codex Alimentarius develops food safety standards which serve as a reference for international food trade. This was set up in the 1960s as a joint instrument of the UN FAO and the WHO with the primary mission to protect the health of consumers and ensure fair practices in international food trade. Thus, Codex Alimentarius Commission adopts standards for commodities, codes of practice and maximum limits for additives, contaminants, pesticides residues and veterinary drugs.
Following the conclusion of the Uruguay Round in 1994, the role of Codex Alimentarius Standards was strengthened. The WTO Agreement on SPS measures considers that WTO members applying the Codex Alimentarius standards meet their obligations under this Agreement. Additional information and updates can be obtained from http://www.wto.org (see also WTO, 1999 ).
Traditional trade protection has been reduced by the 1994 GATT agreement, which means that SPS measures assume greater importance in determining market access (see Henson and Loader, 2001 , Unnevehr, 2000 , Zepeda et al., 2001 , Jukes, 1993 , Jukes, 2000 , Kastner and Pawsey, 2002a and Kastner and Pawsey, 2002b ). The challenges and issues food safety standards for export across trade barriers includes (1) the importance of fresh food product trade by region and the kinds of issues that arise from those products, (2) the role of farm to table approaches and HACCP (see Fig. 3 ) in ensuring safety, (3) the role of the public sector in WTO member countries and the less developed countries in facilitating trade and (4) the potential role of the SPS Agreement in resolving disputes and determining equivalency of standards between high and low income countries.
Fig. 3.
Application of the principles of HACCP. Food supply chain management systems in assuring safety and quality is interfaced by a prerequisite requirement (e.g., good manufacturing practice (GMP), good hygiene practice (GHP)), food safety assurance plan (e.g., HACCP plan), a quality system and a cultural/managerial approach (e.g., ISO 9000, TQM, etc.).
3. Hazard analysis at critical control point (HACCP)
The health status of a population can be evaluated by use of the microbiological risk assessment (MRA) for a product or product group to which a pathogen is associated.
On a population basis, a calculation of risk can predict the expected number of specific illnesses or deaths per 100,000 population per year attributable to the pathogen/food in question, or risk can be defined as the probability of a specific adverse outcome per exposure to the food. An MRA can give an absolute or a relative indication of the health status, i.e. provide an absolute numerical expression of the risk at population level, respectively, a relative or benchmarked expressing (e.g., a ranking). This applies whether the food product originates from one country or is imported into it. Applicable definitions in risk analysis based food control are presented in Fig. 4 .
Fig. 4.
Risk assessment criteria. Appropriate level of protection (ALOP), level of protection deemed appropriate by the member (country) establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory; food safety objective (FSO), this refers to the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the appropriate level of protection ALOP. FSO is just one of the options to give guidance to food safety management the expected management of risks; performance objective (PO), the maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable; performance criterion (PC), the effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a PO or an FSO; control measure (CM), any action and activity that can be used to prevent or eliminate a food safety hazard or to reduce it to an acceptable level (it can be microbiological specifications, guidelines on pathogen control, hygiene codes, microbiological criteria, specific information (e.g., labeling), training, education and others).
The food industry is not only responsible for producing safe food but also for demonstrating in a transparent manner how food safety has been planned. For example, hazards which have been considered in production and the measures that have been put in place to ensure the safety of products. This is done through the development of HACCP studies and HACCP plans as part of the food safety assurance system HACCP is a straightforward and logical system of control based on the prevention of problems “a common sense approach to food safety management”.
HACCP merits in food safety management can be realized only if the people charged with its implementation have the knowledge and expertise to apply it effectively. This could be a combination of horizontal and vertical partnerships as in the poultry industry. The resulting network involved all kinds of parties in the industry from breeding farms down to the packing stations, along with feed producers, veterinarians and a quality service organization. The need is to guarantee the quality of poultry products to the consumer and to provide information for associated transparency. Seminal discussions on the workings of HACCP and application to several food sectors are widely reviewed in the literature to which the reader is referred, e.g., Codex (1997) , Mortimore (2001) , Sperber, 1998 , Sperber, 2005a and Sperber, 2005b , Sun and Ockerman (2005) , Azanza (2006) and Jeng and Fang (2003) ; http://www.codexalimentarius.net , http://www.wto.org and http://www.fao.org .
“Hazard” is “a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect” ( Codex, 1997 ). Hazard analysis, therefore, requires that both the likelihood of occurrence and severity of that hazard are considered, in effect an assessment of risk. Validation of the hazard analysis is an important element and, probably the key principle in the whole HACCP system and the one which many find difficult to apply. CCPs can be designated a prerequisite so as not to undermine the whole process. For example, failure to wash hands if not designated as a prerequisite hygiene program can create problems if regarded as a CCP and it is not adhered to. It is no accident that HACCP evolved at the food processing step of the farm to table supply chain (see Fig. 1 ). It is at this step that effective controls, such as cooking, drying, irradiation, acidification, or refining are available to eliminate significant hazards. Two typical examples are pasteurized dairy products and in canned foods. Here food safety is assured by process control, not by finished product testing. HACCP is of critical importance to the food service sector as it helps to ensure that the whole production line of the food chain is acceptable and which is necessary to improve public health. For HACCP to be effective when targeting the specific needs of the retail food establishment, it must be compatible with the products sold, the clients served and the facilities and equipment used during food production.
Food safety management as in GMP, GHP and HACCP provisions, are specific to the available facility, the processing line and the exact product composition and processing. So for a specific food product, microbiological risk assessment considers all foods consumed in a country, whether produced in that country or imported; it involves all different production facilities, a multitude of production-lines and product compositions and processing. MRA takes a generic, population level view on the overall production and marketing of a food product. Risk assessment is a science-based investigation consisting of four steps: hazard identification, exposure assessment, hazard characterization and risk characterization as outlined in Fig. 5 , itself based on is the framework adopted by the Codex Alimentarius Commission (see Lammerding and Fazil, 2000 ). “Hazard identification identifies the issues of concern and provides the focus of the risk assessment. The exposure assessment generates estimates of the likelihood and magnitude of exposure to the hazard, setting the stage for the next two steps of the assessment, hazard characterization and risk characterization, in which the exposure outputs are translated into a measure of risk” ( Lammerding and Fazil, 2000 ). Governmental risk managers may choose to implement specific risk management measures (standards, microbiological criteria, hygiene code, labeling, education, etc.) in addition to an FSO. Such measures may be relevant to all or the majority of supply chain so they should be included in all cases. Alternatively, such measures may be essential additions to the target without which the ALOP may not be met. FSO is just one of the options to give guidance to food safety management the expected management of risks. As there are often many links in a food supply chain ( Fig. 1 ), it is clear that establishing and/or define several operational targets along the chain will help ensure that the chain as a whole operates to meet the FSO at consumption. HACCP is a major contributor to overall quality assurance system (ISO 9000) in international food trade.
Fig. 5.
Risk assessment is a science-based investigation consisting of four steps: hazard identification, exposure assessment, hazard characterization and risk characterization in accordance with the framework adopted by the Codex Alimentarius Commission ( Lammerding and Fazil, 2000 ).
