Toxicology 221 (2006) 119–127
The impact of food regulation on the food supply chain
Okezie I. Aruoma
Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA, United Kingdom
Received 4 October 2005; received in revised form 8 December 2005; accepted 15 December 2005
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. ? 2006 Elsevier Ireland Ltd. All rights reserved.
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 all stages of the food supply chain, from farm to con- Organization (WTO) sumers (Fig. 1). There is a need to balance the bene?ts of
increased food supplies through technological processes
against associated health and economic risks, a need Food regulation in the main is aimed at protecting the that is of increasing importance given the rising trend in consumer‟s health, increasing economic viability, har- world population, the opening up of boundaries, migra- monizing well-being and engendering fair trade on foods tion, urbanization, and with these, changing food habits. within and between nations. Agricultural mechanization and industrial food process- Many factors that affect the food systems include ing advocated in Fig. 1 embrace that foods produced the climate, available arable land, technology (from the and presented to the markets have to meet standards that standpoint of production, preservation, processing and are universally acceptable. Thus, food legislation assures storage). A modern food control program centers at 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, ?sh, vegetables, processed
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120 O.I. Aruoma / Toxicology 221 (2006) 119–127
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.
and packaged and ready to eat foods are ?nding their way for international commerce. Essentially, the agreements across international boundaries and meeting competition are contracts that guarantee member countries important with indigenous manufacturers. trade rights and are there to help producers of goods and
The World Trade Organization formed in 1995 is services, exporters and importers to conduct their busi- the only global international organization dealing with ness. The instruments also bind governments to keep the rules of trade between nations. At its heart are the their trade policies within agreed limits to everybody‟s WTO agreements, negotiated and signed by the bulk bene?t. Although the government‟s regulatory mecha- of the world‟s trading nations and rati?ed in their par- nisms oversees the analyses of public health problems liaments. The goal is to help producers of goods and and their association to the food supply, food safety is services, exporters and importers conduct their business still mainly the responsibility of the consumer, they nev- (Fig. 2). These agreements are the legal ground-rules ertheless 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.
O.I. Aruoma / Toxicology 221 (2006) 119–127 121
The activities of the WTO can be summarized as fol- conditions, and help in formulating management sys- lows: tems, e.g., HACCPs for niche products for developing
countries are within the context of seeking harmoniza-
tion in world trade. • administering trade agreements; Yapp and Fairman (2006) have reviewed the fac- • acting as a forum for trade negotiations; tors affecting food safety compliance within small and • settling trade disputes; medium-sized enterprises (SMEs) and the implications • reviewing national trade policies; for regulatory and enforcement strategies in the UK. • assisting developing countries in trade policy issues The ?ndings were quite remarkable. Among the identi- through technical assistance and training; ?ed factors were: lack of money (where SMEs focus on • cooperating with other international organizations. immediate survival rather than potential bene?ts derived
over the long term) and lack of time. Time has tended
to prevent the identi?cation and interpretation of reg-
ulations, thereby preventing further action being taken Whilst it is clear that developed countries monitor by SMEs. More interesting however is the realization their food systems with the expected outcome in provid- that food sector SMEs do not see these steps as part ing a consistent and constant supply of safe and whole- of their business operation. This was viewed as the some food, many developing countries battle with an duty of the external agencies such as the environmental unsafe and inadequate food supply. This leads to heavy health practitioners (EHPs) who inspect food businesses economic losses (particularly scarce foreign exchange) according to criteria contained within Code of Practice and health hazards ranging from malnutrition to food- issued under Section 40 of the Act UK‟s Food Standards borne illnesses. Interestingly, whilst economic globaliza- Agency. Yapp and Fairman argued that this reactive atti- tion can easily equate with the expansion of international tude rather than a lack of time prevents identi?cation and trade, it is clear that some developing countries continue interpretation of regulations by SMEs. Lack of experi- to struggle to become fully integrated into the world trad- ence, lack of access to information (seen as a problem ing system. It is critical therefore to improve awareness, with overprovision of information resulting in confusion simplify rules, improve skills and infrastructure, adapt about relevance), lack of support (where SMEs perceive food safety monitoring to local conditions, and help for- that support is biased towards larger companies), lack mulating risk management systems for niche products of interest (where SMEs focus upon business survival from developing countries (Brown et al., 2002; Anyanwu rather than compliance with regulations) and lack of and Jukes, 1991; Juke, 1988; Jukes, 2000; Henson and knowledge (where SMEs have poor awareness of the Loader, 2001; Schillhorn van Veen, 2005; Henson et relevance of legislation) were noted. Quoting the work al., 2005). As argued by Henson et al. (2005), “there of Reiss (1984), Yapp and Fairman brought attention to are concerns about power relations through the supply the view that “The principal objective of a compliance chain, supermarket demand for high-value fresh produce law enforcement system is to secure conformity with the can provide opportunities for the enhancement of small- law by means of insuring compliance or by taking action scale producer livelihoods” and at the same time, “atten- to prevent potential law violations without the necessity tion has focused on the processes through which small- to detect, process and penalize violators. The principal scale producers are integrated into, or excluded from, objective of deterrence law enforcement systems is to supermarket supply chains and the associated impact of secure conformity with law by detecting violations of stricter food safety and quality standards and logistics law, determining who is responsible for their violation, requirements”. and penalizing violators to deter violations in the future”. The confusion between quality and safety, over regu- It is clear that these considerations are not dissimilar lation, selective enforcement, lack of integration of food from the experience of other SME in the world market. laws and regulations in the overall legislative system, the The intent of the Global Agreement on Tariffs and multiplicity of responsible agencies, and the mismatch Trade has been one of streamlining international trade. between the required standards are among the major In the early phases of GATT, most attention was given issues that the World Bank have come to realise. So poor to trade and trade con?icts between large trading blocks economics, poor infrastructure and lagging skills have and markets such as the United States, European Com- negative impact on trade for the developing countries. munity, Japan, etc. and too little to the interests of smaller Improving food safety along the standards of the devel- developing countries. So the developing countries (or the oped economies, however, may carry considerable costs less developed countries) have been left to adopt the rules and price food out of reach of the poor. Indeed improv-
ing awareness, simplifying rules, improving skills and
infrastructure, adapting food safety monitoring to local
122 O.I. Aruoma / Toxicology 221 (2006) 119–127
that were speci?cally created for these large markets, and pretations and appeals of dispute settlements without given little time to adjust their institutions to assure that serious efforts by all parties to ?nd win–win solutions. export products are in compliance with, to them exotic, The most ?agrant trade violations have been eliminated food safety rules. Thus, the introduction and applica- as a result of improved transparency in the process. Con- tion of food safety tools and rules need to be affordable sumers are in general better off, since they have greater and build on local food management customs rather than diversity and increased safety in what they can buy. The simply imposing standards that are expensive to monitor guidelines of the World Bank in its 2002 handbook on (Henson et al., 2005; Key and Runsten, 1999; Nguz, in the magnitude of border barriers and trade liberalization press; Kroes and Walker, 2004; Chen, 2004; Zepeda et upon which the foregoing comments were based, can be al., 2001). Such an application has its bene?t as Baker summarized as seeking to foster: (2002) observed “a HACCP based food safety system
that was integrated with restaurant policies, operations,
documentation and communication strategies could have
• effective market access that has a wider dimension avoided the costly exercise of removing a highly prof-
than border restrictions on goods; itable menu item, the associated loss of market momen-
• reciprocal liberalization for developing countries that tum, heightened regulatory scrutiny and the potential to
achieves improved access to markets abroad and raise questions of consumer con?dence.”
greater openness at home, but there are major political The WTO SPS Agreement relates to three main
economy constraints to be overcome; issues: food safety, animal health and plant health. In
• trade liberalization to form only a small part of the each case, the Agreement identi?es an international body
comprehensive domestic reforms that are needed to as providing the basic standards against which disputes
deliver poverty-reducing growth; over national regulations would be judged.
• better analysis of the costs and bene?ts of global trade Under the WTO SPS Agreements and the codes of
rules for developing countries; practices issued by the Codex Alimentarius Commission
• integrating developing countries more effectively into constitute the benchmark for international harmoniza-
the global economy. tion that guarantee the trade of safe food (Jukes, 1993,
2000; 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 environ-
2. Sanitary and Phytosanitary Agreements mental and health standards and restrictive rules of ori-
gin, as well as restrictions and regulations that limit the
ability of developing countries to sell services abroad, Global harmonization of food safety regulations will especially through the temporary movement of workers undoubtedly help to ensure fair competition among (World Bank, 2002; Schillhorn van Veen, 2003). It is countries in terms of trade and at the same time it clear that trade liberalization needs to be complemented will enable all populations enjoy the same degree of by a number of other policies such as sound macroeco- food safety. This was one of the ideas behind the nomic management, effective regulation (e.g., ?nancial Uruguay Round of Multilateral Trade Negotiations, services), and improved customs and tax administration. which resulted in the creation of the WTO in 1995, This needs to embrace the policies and institutions to including a number of agreements, e.g., the Agreement support social objectives and safeguard the interests of on the Application of SPS and the Agreement on Tech- the poorest in society. Further, global trade rules need to nical Barriers to Trade (TBT). be de?ned from a developmental perspective if they are The Agreement on the Application of Sanitary and to serve as tools for poverty reduction. In this context, Phytosanitary Measures (the “SPS Agreement”) came capacity building measures should include bolstering into force with the formation of the World Trade Orga- the ability of stakeholders in developing countries to nization (WTO, 1995). The SPS agreement was aimed participate in the development and implementation of at controlling issues affecting food safety measures. trade-related policies and global trading rules. Although some constraints had been applied by the orig- Compliance with the decision of the WTO remain inal General Agreement on Tariffs and Trade (GATT) in an area of concern given the tendency of developed and 1947, under Article XX(b), it was believed that vari- powerful countries continuing to threaten the survival of ous countries were using food safety concerns to jus- the WTO system through lengthy and costly legal inter- tify, maintaining or erecting food regulations against
imported foods which were a barrier to trade. One major
quali?cation 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
O.I. Aruoma / Toxicology 221 (2006) 119–127 123 protection than would be achieved by measures based areas within an exporting country is recognized. Exports on the relevant international standards, guidelines or rec- can be allowed from such areas, even if other areas of an ommendations if there is a scienti?c justi?cation, or as exporting country still have the disease or pest. Coun- a consequence of the level of sanitary or phytosanitary tries may choose a risk standard that differs from the protection a member determines to be appropriate in international standard. This recognizes that individual accordance with the relevant provisions. . .”. To help with nations are unwilling to subscribe to uniform interna- interpretation, the term „scienti?c justi?cation‟ was fur- tional standards for all hazards. There is a clearly de?ned ther de?ned as follows: “there is a scienti?c justi?cation mechanism for resolving disputes between countries in a if, on the basis of an examination and evaluation of avail- timely manner. The dispute settlement panel is expected able scienti?c information in conformity with the rele- only to state whether the SPS measures under ques- vant provisions of this agreement, a member determines tion have a scienti?c basis and are consistently applied. that the relevant international standards, guidelines or Further, Member nations recognize the desirability of recommendations are not suf?cient to achieve its appro- common SPS measures.
priate level of sanitary or phytosanitary protection.” Three international organizations are recognized as
The term “sanitary or phytosanitary measure” is sources of internationally agreed-upon standards: (1) de?ned as any measure applied to protect human, animal, The Codex Alimentarius Commission (Codex), (2) The or plant life or health from certain risks, including risks International Of?ce of Epizootics (OIE) and (3) The arising from: (i) the spread of pests, diseases, disease- International Plant Protection Convention (IPPC). Brief carrying organisms or disease-causing organisms, (ii) the comments on the ?rst of these follow. The Codex Ali- presence of additives, contaminants, toxins or disease- mentarius develops food safety standards which serve causing organisms in foods, beverages or feeds and (iii) as a reference for international food trade. This was diseases carried by animals, plants or products thereof. set up in the 1960s as a joint instrument of the UN The SPS Agreement, therefore, includes a broad scope of FAO and the WHO with the primary mission to pro- activities related to food safety as well as the protection tect the health of consumers and ensure fair practices of animal and plant health. As such, the SPS Agree- in international food trade. Thus, Codex Alimentarius ment applies to all sanitary and phytosanitary measures Commission adopts standards for commodities, codes that may affect international trade. Exporters must meet of practice and maximum limits for additives, contami- the quality and safety demanded by import market con- nants, pesticides residues and veterinary drugs. sumers. For this reason, international trading rules are in Following the conclusion of the Uruguay Round in place in order to ensure that public standards are applied 1994, the role of Codex Alimentarius Standards was fairly and equally to domestic and imported products. strengthened. The WTO Agreement on SPS measures WTO members supported the following SPS principles considers that WTO members applying the Codex Ali- (WTO, 1999): mentarius standards meet their obligations under this
Agreement. Additional information and updates can
be obtained from http://www.wto.org (see also WTO,
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, 2000; Kastner and Pawsey, • transparency; 2002a,b). The challenges and issues food safety stan- • equivalence; dards for export across trade barriers includes (1) the • harmonization; importance of fresh food product trade by region and the • science-based measures; kinds of issues that arise from those products, (2) the • regionalization; role of farm to table approaches and HACCP (see Fig. 3) • national sovereignty; in ensuring safety, (3) the role of the public sector in • dispute resolution. WTO member countries and the less developed coun-
tries 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 Hence, nations are required to publish their regulations countries. 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 scienti?c basis
for reducing risk. The concept of pest- or disease-free
124 O.I. Aruoma / Toxicology 221 (2006) 119–127
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 of problems “a common sense approach to food safety (HACCP) management”.
HACCP merits in food safety management can be
realized only if the people charged with its implementa- The health status of a population can be evaluated tion have the knowledge and expertise to apply it effec- by use of the microbiological risk assessment (MRA) tively. This could be a combination of horizontal and ver- for a product or product group to which a pathogen is tical partnerships as in the poultry industry. The resulting associated. network involved all kinds of parties in the industry from On a population basis, a calculation of risk can breeding farms down to the packing stations, along with predict the expected number of speci?c illnesses or feed producers, veterinarians and a quality service orga- deaths per 100,000 population per year attributable to nization. The need is to guarantee the quality of poultry the pathogen/food in question, or risk can be de?ned as products to the consumer and to provide information the probability of a speci?c adverse outcome per expo- for associated transparency. Seminal discussions on the sure to the food. An MRA can give an absolute or a workings of HACCP and application to several food sec- relative indication of the health status, i.e. provide an tors are widely reviewed in the literature to which the absolute numerical expression of the risk at population reader is referred, e.g., Codex (1997), Mortimore (2001), level, respectively, a relative or benchmarked expressing Sperber (1998, 2004, 2005a,b), Sun and Ockerman (e.g., a ranking). This applies whether the food product (2005), Azanza (2006) and Jeng and Fang (2003); originates from one country or is imported into it. Appli- http://www.codexalimentarius.net, http://www.wto.org cable de?nitions in risk analysis based food control are and http://www.fao.org. presented in Fig. 4. “Hazard” is “a biological, chemical or physical agent The food industry is not only responsible for produc- in, or condition of, food with the potential to cause an ing safe food but also for demonstrating in a transparent adverse health effect” (Codex, 1997). Hazard analysis, manner how food safety has been planned. For example, therefore, requires that both the likelihood of occurrence hazards which have been considered in production and and severity of that hazard are considered, in effect an the measures that have been put in place to ensure the assessment of risk. Validation of the hazard analysis is safety of products. This is done through the development an important element and, probably the key principle in of HACCP studies and HACCP plans as part of the food the whole HACCP system and the one which many ?nd safety assurance system HACCP is a straightforward dif?cult to apply. CCPs can be designated a prerequisite and logical system of control based on the prevention
O.I. Aruoma / Toxicology 221 (2006) 119–127 125 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 speci?ed 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 speci?cations, guidelines on pathogen control, hygiene codes, microbiological criteria, speci?c information (e.g., labeling), training, education and others).
so as not to undermine the whole process. For example, a country, whether produced in that country or imported; failure to wash hands if not designated as a prerequi- it involves all different production facilities, a multitude site hygiene program can create problems if regarded of production-lines and product compositions and pro- as a CCP and it is not adhered to. It is no accident that cessing. MRA takes a generic, population level view on HACCP evolved at the food processing step of the farm the overall production and marketing of a food product. to table supply chain (see Fig. 1). It is at this step that Risk assessment is a science-based investigation consist- effective controls, such as cooking, drying, irradiation, ing of four steps: hazard identi?cation, exposure assess- acidi?cation, or re?ning are available to eliminate sig- ment, hazard characterization and risk characterization ni?cant hazards. Two typical examples are pasteurized as outlined in Fig. 5, itself based on is the framework dairy products and in canned foods. Here food safety is adopted by the Codex Alimentarius Commission (see assured by process control, not by ?nished product test- Lammerding and Fazil, 2000). “Hazard identi?cation ing. HACCP is of critical importance to the food service identi?es the issues of concern and provides the focus of sector as it helps to ensure that the whole production line the risk assessment. The exposure assessment generates of the food chain is acceptable and which is necessary to estimates of the likelihood and magnitude of exposure improve public health. For HACCP to be effective when to the hazard, setting the stage for the next two steps of targeting the speci?c needs of the retail food establish- the assessment, hazard characterization and risk charac- ment, it must be compatible with the products sold, the terization, in which the exposure outputs are translated clients served and the facilities and equipment used dur- into a measure of risk” (Lammerding and Fazil, 2000). ing food production. Governmental risk managers may choose to implement
Food safety management as in GMP, GHP and speci?c risk management measures (standards, microbi- HACCP provisions, are speci?c to the available facility, ological criteria, hygiene code, labeling, education, etc.) the processing line and the exact product composition in addition to an FSO. Such measures may be relevant and processing. So for a speci?c food product, microbi- to all or the majority of supply chain so they should be ological risk assessment considers all foods consumed in included in all cases. Alternatively, such measures may
126 O.I. Aruoma / Toxicology 221 (2006) 119–127
Fig. 5. Risk assessment is a science-based investigation consisting of four steps: hazard identi?cation, exposure assessment, hazard characterization and risk characterization in accordance with the framework adopted by the Codex Alimentarius Commission (Lammerding and Fazil, 2000).
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