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Manuscript Number: FOODPOLICY-D-13-00499R1

Title: Exploring the influence of context on food safety management: Case studies of leafy greens
production in Europe

Article Type: Full Length Article

Keywords: fresh produce; leafy greens; food safety management; food safety governance; co-
regulation; systems thinking; context

Corresponding Author: Dr. Pieternel Arianne Luning, Ph.D.

Corresponding Author's Institution: Wageningen University and Research Centre

First Author: Klementina Kirezieva

Order of Authors: Klementina Kirezieva; Liesbeth Jacxsens; Geoffrey Hagelaar; Martinus van Boekel;
Mieke Uyttendaele; Pieternel Arianne Luning, Ph.D.

Abstract: Fresh produce companies operate their food safety management systems (FSMS) in a
complex context. On the one hand, during setting and operating their FSMS activities, companies need
to consider the riskiness of the 'FSMS context' of the company, including the risk of product and
production, and the limitations and opportunities of the organisational and chain characteristics. On
the other hand, both the narrow 'FSMS context' and the actual FSMS, are influenced by the 'broad
context' in a country and sector, encompassing different climate, landscape, political and market
environment. This is especially true for fresh produce and leafy greens, which are vulnerable to
contamination from environment, and contextual influences such as globalization of trade and climate
change.
This study aimed to assess the status of FSMS in the leafy greens sector; and to explore the 'broad
context' and the mechanisms through which it can influence the 'FSMS context' in a company, FSMS
activities and the system output. The 'broad context' was defined to include four sub-systems: agro-
climatic, market and public policy environments, and food safety governance, which aims at inducing
compliance to food safety requirements by the companies.
Three case studies of leafy greens production were analysed, intentionally chosen to represent three
European regions with their specific contexts. It was observed that the sub-systems of the 'broad
context' can influence the 'FSMS context', FSMS activities and their system output. The approaches to
food safety governance in the case studies have ranged between market self-regulation, co-regulation
and state-controlled regulation, which related to the governance traditions in the three European
regions.
The companies operating in favourable 'broad context', including favourable climate, big companies in
integrated market, and stringent standards as a result of market self-regulation, have demonstrated
advanced FSMS, good information about the output and supporting organisational characteristics. The
FSMS of the companies that were operating in less favourable 'broad context', either in fragmented
market with small companies or in less favourable climate, have demonstrated less mature FSMS. In
the case of applied public policy intervention (subsidies and import tariffs) and baseline food safety
standards, domestically supplying companies realised average FSMS, based on 'best available'
knowledge and experience. This was not the case with the small companies operating in fragmented
market, which demonstrated basic FSMS and lack of support from organisational characteristics. These
companies have been dealing with both domestic and export market, certified against both private and
public standards.
As a conclusion, we postulate that the FSMS output is a function of the broad context in a country and
sector, the 'FSMS context' in a company, and implemented food safety management system.
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1 Exploring the influence of context on food safety management: Case studies of leafy greens

2 production in Europe

4 Abstract

5 Fresh produce companies operate their food safety management systems (FSMS) in a

6 complex context. On the one hand, during setting and operating their FSMS activities,

7 companies need to consider the riskiness of the ‘FSMS context’ of the company, including the

8 risk of product and production, and the limitations and opportunities of the organisational and

9 chain characteristics. On the other hand, both the narrow ‘FSMS context’ and the actual

10 FSMS, are influenced by the ‘broad context’ in a country and sector, encompassing different

11 climate, landscape, political and market environment. This is especially true for fresh produce

12 and leafy greens, which are vulnerable to contamination from environment, and contextual

13 influences such as globalization of trade and climate change.

14 This study aimed to assess the status of FSMS in the leafy greens sector; and to explore the

15 ‘broad context’ and the mechanisms through which it can influence the ‘FSMS context’ in a

16 company, FSMS activities and the system output. The ‘broad context’ was defined to include

17 four sub-systems: agro-climatic, market and public policy environments, and food safety

18 governance, which aims at inducing compliance to food safety requirements by the

19 companies.

20 Three case studies of leafy greens production were analysed, intentionally chosen to represent

21 three European regions with their specific contexts. It was observed that the sub-systems of

22 the ‘broad context’ can influence the ‘FSMS context’, FSMS activities and their system

23 output. The approaches to food safety governance in the case studies have ranged between

24 market self-regulation, co-regulation and state-controlled regulation, which related to the

25 governance traditions in the three European regions.

1
26 The companies operating in favourable ‘broad context’, including favourable climate, big

27 companies in integrated market, and stringent standards as a result of market self-regulation,

28 have demonstrated advanced FSMS, good information about the output and supporting

29 organisational characteristics. The FSMS of the companies that were operating in less

30 favourable ‘broad context’, either in fragmented market with small companies or in less

31 favourable climate, have demonstrated less mature FSMS. In the case of applied public policy

32 intervention (subsidies and import tariffs) and baseline food safety standards, domestically

33 supplying companies realised average FSMS, based on ‘best available’ knowledge and

34 experience. This was not the case with the small companies operating in fragmented market,

35 which demonstrated basic FSMS and lack of support from organisational characteristics.

36 These companies have been dealing with both domestic and export market, certified against

37 both private and public standards.

38 As a conclusion, we postulate that the FSMS output is a function of the broad context in a

39 country and sector, the ‘FSMS context’ in a company, and implemented food safety

40 management system.

2
41 Introduction

42 Many efforts have been put into implementing food safety management systems (FSMS) in

43 companies in the food production chain (Konecka-Matyjek et al., 2005; Fotopoulos et al.,

44 2010; Mensah and Julien, 2011). In scientific research the focus was largely on investigating

45 the status and effectiveness of FSMS in the animal sector (i.e. dairy and meat) (Jacxsens et al.,

46 2010a; 2011; Sampers et al., 2012; Luning et al., 2013). More recently, incidences of

47 foodborne illnesses have triggered the attention of the public to safety of fresh produce such

48 as leafy greens (Lynch et al., 2009; Altmann et al., 2011; Baert et al., 2011). These outbreaks

49 have been occurring worldwide and due to the large volume of international trade with these

50 commodities, several of them involved multiple countries (e.g., Greig et al., 2007; Lynch et

51 al., 2009; Gajraj et al., 2011). Furthermore, pesticide residues are still an important issue

52 (Chen et al., 2011; Hjorth et al., 2011), and the risk is perceived as high by consumers

53 (Cerroni et al., 2013; Van Boxstael et al., 2013).

54 To mitigate the risks to food safety, companies have put efforts into upgrading their food

55 safety management systems (FSMS). These systems at primary production are commonly

56 based on good agriculture and good hygiene practices, however, no special provisions or

57 guidelines are yet elaborated regarding their actual implementation within the European

58 Union (EU). The EU policies are following the principles of subsidiarity and multi-level

59 governance, which aim at distributing the policy responsibility among different governmental

60 levels, and among the public and private sector, as decision-making takes place at the lowest

61 possible level (Bernauer and Caduff, 2004). These principles are enforced differently in each

62 member state by following different public strategies to induce compliance and often leaving

63 a lot of room for industrial self-regulation (Caduff and Bernauer, 2006; Havinga, 2006). This

64 niche is covered by various private standards (e.g., GlobalGAP, IFS, Marks & Spencer’s

65 Field-to-Fork, Tesco Nature’s Choice), commonly imposed by the retailers. De jure they are

3
66 voluntary, but de facto food business operators need to conform with them to gain market

67 access (Humphrey, 2005; Fulponi, 2006; Henson, 2008). This whole set of legislation and

68 standards, organisations (public and private) and processes involved in their enforcement, are

69 described by the term food safety governance (Renn et al., 2011).

70 Food safety governance is part of the broader context of a sector and country that can have an

71 influence on FSMS. Primary production of fresh produce is particularly vulnerable to

72 contextual influences such as contamination from people and environment, including

73 agricultural workers, irrigation water, manure, surroundings, wild life, etc. (FAO, 2008b;

74 Berger et al., 2010). Furthermore, fresh produce and leafy greens are increasingly traded

75 globally, grown and processed under diverse conditions, following different legislation and

76 standards (Powell et al., 2009). They are mostly consumed raw, and there is limited

77 possibility to apply intervention for elimination of any contamination, even further down in

78 the chain for derived products, such as fresh-cut salads. Moreover, fresh produce is

79 susceptible to climate change impacts (Liu et al., 2013; Kirezieva et al., 2014).

80 Previous research described the relationships between the context and quality and food safety

81 management systems and their output (Spiegel et al., 2006; Luning et al., 2011b; Kirezieva et

82 al., 2013b). Empirical studies showed that companies working in a high risk context need

83 more advanced FSMS activities to be able to achieve a good output (Sampers et al., 2010;

84 Luning et al., 2011a; Osés et al., 2012; Luning et al., 2013). However, these studies focused

85 on the context of FSMS on a company level and the broad environment of the country and

86 sector was not taken into account. The latter has been partly addressed in political economy

87 research investigating the food safety governance and the mechanisms behind public and

88 private enforcement (e.g., Stuart, 2010; Rouvière and Caswell, 2012; Richards et al., 2013).

89 These studies, however, do no investigate the effect of food safety governance on FSMS

90 implemented in companies. To our knowledge, only one study focused both on the food

4
91 safety governance and its influence on food safety management systems on a company level

92 (Jacxsens et al., 2013). No research yet explores the elements of the broad context in a

93 country and a sector that can affect the actual implementation of FSMS in companies.

94 Therefore, the objective of the study was twofold: 1) to assess the status of FSMS in the leafy

95 greens sector; 2) to explore the ‘broad context’ and the mechanisms through which it can

96 influence the ‘FSMS context’ in a company, FSMS activities and the system output. This

97 paper presents an analytical framework with operational tools that enables assessment of the

98 status of food safety management systems in view of the context riskiness at company level,

99 and exploration of the influence of the ‘broad context’ in a country and sector. The latter

100 included food safety governance, agro-climatic, market, and public policy environment. The

101 model is a first step towards conceptualisation of the complex systems influencing FSMS

102 implementation and operation in companies. It builds on previously developed theories about

103 status of FSMS in fresh produce companies in view of their company specific FSMS context

104 (Kirezieva et al., 2013a; 2013b).

105

106 Analytical framework

107 The analytical framework (Figure 1) shows a schematic representation of the FSMS as

108 influenced by their narrow and broad context. The analytical framework is grounded on the

109 systems thinking approach aimed to study how systems behave, interact with their context and

110 influence each other (Von Bertalanffy, 1969). The general systems theory describes that all

111 systems constitute of elements, have a structure of sub-systems and participate in bigger

112 hierarchy of systems (Skyttner, 2005). In the analytical framework were considered two

113 systems: 1) the companies with their unique FSMS and context, and 2) the broad context in

114 which they operate with its sub-systems including food safety governance, agro-climatic,

115 market and public policy environment. To assess the FSMS and their context, we used a

5
116 previously developed diagnostic tool (Kirezieva et al., 2013a; 2013b). Moreover, an

117 additional tool was developed to explore the broad context with its sub-systems, and their

118 influence on the FSMS.

119

120 Diagnostic tool for assessing status of FSMS in fresh produce

121 In the lower level of our hierarchy we have considered the food companies with their FSMS.

122 To collect information we have used a diagnostic tool which allows assessment of the ‘FSMS

123 context’, FSMS activities and the FSMS output (Kirezieva et al., 2013a; 2013b). The ‘FSMS

124 context’ consist of the product, production, organisation and chain characteristics of the

125 company that can create riskiness to the decision-making process during the set-up and

126 operation of the FSMS with its control and assurance activities, and thus their final FSMS

127 output. Riskiness is created by the vulnerability of the products, uncertainty due to lack of

128 information and ambiguity due to lack of understanding (Luning et al., 2011b). Companies

129 can reduce the riskiness of the ‘FSMS context’ by addressing it in the FSMS activities with

130 systematic methods and independent positions, adequate and science-based information

131 (Luning et al., 2011b).

132 To allow for measurement, indicators with corresponding stereotypical situation descriptions,

133 in which companies have to position themselves, were defined in the diagnostic tool. For each

134 context indicator three situational descriptions represent low (situation 1), moderate (situation

135 2), and high risk (situation 3) to decision-making during setting and operating the FSMS

136 activities. For the context factors product and production characteristics, the low, moderate,

137 and high risk situation represent, low, potential, and high chance of microbial or chemical

138 contamination, growth, and or survival of pathogens, and other undesired microorganisms.

139 The low, moderate, and high risk situations for organisational characteristics respectively

140 correspond with supportive, constrained (restricted), and lack of administrative conditions for

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141 appropriate decision-making during set-up and operation of FSMS. For the chain

142 characteristics, the descriptions for low, moderate, and high risk situation correspond to low,

143 restricted, and high vulnerability to safety problems or dependability on other chain actors

144 (Luning et al., 2011b; Kirezieva et al., 2013b).

145 For each control and assurance activity indicator three stereotypical descriptions represent

146 basic (situation 2), average (situation 3), and advanced situation (situation 4) (Luning et al.,

147 2008; 2009; Kirezieva et al., 2013a). Situation 1 is given when an activity is not possible in

148 the given production circumstances, it is not applied, although it is possible, or no information

149 is available. The basic situation (2) for control activities represents standard equipment,

150 unknown capability, use of own experience/general knowledge, incomplete methods,

151 restricted information, lack of critical analysis, and non-procedure-driven activities. For

152 assurance, the basic (2) is typified by problem driven, only checking, scarcely reported, not

153 independent positions. The average situation (3) for control activities represents activities that

154 are based on the following aspects: expert (supplier) knowledge, use of (sector, governmental)

155 guidelines, best practices, standardised, generic information and sometimes problems. The

156 average situation for assurance activities represents active translation of requirements,

157 additional analysis, regular reporting, and experts support. The advanced situation (4) for

158 control and assurance activities represents the use of specific information, scientific

159 knowledge, critical analysis, procedural methods, systematic activities, and independent

160 positions.

161 The output of the activities is measured through performance indicators, and the situations

162 represent no information (situation 1), poor (situation 2), moderate (situation 3), and good

163 output (situation 4) (Jacxsens et al., 2010b; Kirezieva et al., 2013a). Poor output represents

164 situations with ad-hoc sampling, minimal criteria used for evaluation, and having various food

165 safety problems or remarks during inspections/audits. Moderate output represents regular

7
166 sampling, several criteria used for evaluation, and having restricted food safety problems

167 mainly due to one (restricted) type of problem. The good output represents systematic

168 evaluation, using specific tailored criteria, and having no safety problems or important

169 remarks during inspections/audits.

170 The overall assumption behind the diagnosis is that companies operating in a high risk context

171 need more advanced FSMS to achieve a good output (Luning et al., 2011b).

172

173 Tool to analyse the broad context

174 On the higher level of our hierarchy we have considered the so-called ‘broad context’ of a

175 country and sector. Based on a literature study four main sub-systems were defined: food

176 safety governance, agro-climatic, market and public policy environment (Fig.1). The criteria

177 used to select these sub-systems was their influence on food safety of fresh produce, through

178 FSMS or its narrow FSMS context. Under agro-climatic environment were considered climate

179 zone and production season; under market environment - structure of the market and supply

180 chain; under public policy environment - subsidies and other policy measures aimed at

181 influencing the market, quality and safety of food products. Food safety governance was

182 analysed separately, which is explained in the next section. The overall hypothesis was that

183 the broad context affects both the FSMS and their output, and the FSMS context consisting of

184 product, production, organisational and chain characteristics (Kirezieva et al., 2013b).

185 The agro-climatic environment can influence the occurrence of pests and plant diseases (FAO,

186 2008a), occurrence and survival of fungi, bacteria, protozoa (Patz et al., 2005; Cotty and

187 Jaime-Garcia, 2007; Fallah et al., 2012; Ge et al., 2012), which are part of the product and

188 production characteristics of the narrow ‘FSMS context’. The agro-climatic environment can

189 also directly affect the effectiveness of pesticides (Abhilash and Singh, 2009), which puts

190 requirements about selection type of pesticides and time of application in the FSMS activities.

8
191 Requirements of the market and food safety governance can directly influence the choice of

192 pesticides and production methods by the farmers (Galt, 2008, 2010), which might be

193 reflected in the FSMS activities and the system output (e.g. pesticide residues in final

194 product). Market and food safety governance may also determine the microbiological limits

195 and allowed control strategies, such as irradiation, disinfection, etc. (Arvanitoyannis et al.,

196 2005). Change of the public policy interventions, such as subsidies and tariff measures, can

197 also affect the choice and amount of pesticides used by the producers (Serra et al., 2005).

198

199 Tool to analyse food safety governance

200 Food safety governance is one of the sub-systems of the ‘broad context’, aimed influencing

201 the FSMS implemented in companies. Governance has been described previously as the

202 institutions, structures of authority and collaboration between stakeholders, aimed at

203 allocating resources and controlling or coordinating an activity (Stephen, 2003). In the case of

204 food safety, it is aimed at assuring compliance of food companies to the food safety standards

205 and regulations (Rouvière and Caswell, 2012). Food safety governance, as any other

206 governance, is the result of public and or private enforcement. Therefore, in the analysis of

207 food safety governance, we have used a theoretical framework for investigating the existing

208 enforcement practices and strategies (Fig. 2), based on May and Burby (1998), Unnevehr and

209 Jensen (1999), Garcia Martinez et al. (2007) and Rouvière and Caswell (2012). The

210 framework allows identification of the strategy and the underlying philosophy applied in the

211 enforcement, by studying the enforcement practices (Fig. 2).

212 Philosophies can be systematic and facilitative (May and Burby, 1998). The systematic

213 approach aims at identifying food business operators that do not comply with legislation and

214 penalise them, while the facilitative seeks to avoid such non-compliances (Rouvière and

215 Caswell, 2012). Different strategies can be employed, and they can have varying degree of

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216 public involvement: from direct command and control by the governmental agencies, to self-

217 regulation, which relies on market solutions (Garcia Martinez et al., 2007). In-between is the

218 co-regulation, which integrates the use of primary regulation and market self-regulation, and

219 involves public-private initiatives (Eijlander, 2005). The enforcement strategy consists of

220 different practices; commonly used ones for the enforcement of food safety are: audits and

221 inspections, incentives (sanctions and stimuli), information and education, and

222 sampling/monitoring (Yapp and Fairman, 2004; Fearne and Garcia Martinez, 2005; Garcia

223 Martinez et al., 2007; Rouvière and Caswell, 2012).

224 Quality assurance standards are usually used to induce compliance by the companies. They

225 are enforced through audits. They can be direct - visits, random or scheduled, but they can be

226 also indirect - through monitoring companies’ records or through (third-party) audits

227 (Rouvière and Caswell, 2012). Besides, monitoring and sampling of the (final) product can

228 also be done. It can be focused on either microbial or chemical safety. Incentives can be

229 applied to stimulate compliance, which may be coercive or rewarding. Sanctions can be

230 imposed upon non-compliance. They can be repressive (e.g., fines, prosecution, recall, closure

231 of facilities, seizure of products, disqualification from market), informative - requiring

232 corrective actions, and ‘naming and shaming’ - providing negative information to the

233 consumers (Rouvière and Caswell, 2012). Stimuli such as awards, labels, tax reduction, can

234 also be employed to encourage compliance (Hampton, 2004; Jacxsens et al., 2013).

235 Furthermore, information and education (such as guidelines, training, advice) are used to

236 support companies, especially in the case of small and medium enterprises (Yapp and

237 Fairman, 2004, 2006; Garcia Martinez et al., 2007).

238

239 Results

240 Application of the analytical framework

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241 Three exploratory case studies have been used to apply the analytical framework and to

242 represent differences in assumed conceptual elements of the ‘broad context’, as suggested by

243 Pettigrew (1988) for theory building. The three main sub-systems of the ‘broad context’ were

244 analysed as follows: Initially, the ‘broad context’ was considered during the design of the case

245 studies by studying three different growing regions of leafy greens in Europe: Murcia (Spain),

246 Lier (Norway) and Flanders (Belgium) with different agro-climatic (typical climate and ways

247 of production). The leafy greens companies were selected to represent different market

248 environment with its typical producers and supply chain. The public policy was addressed by

249 reviewing the main agricultural policy interventions utilized in the sector, such as subsidies

250 and imports tariffs.

251 To collect information about the agro-climatic, market and public policy environment in

252 which companies in the leafy vegetables sector operate we have reviewed literature and

253 conducted interviews with experts in the sectors in these three regions. Food safety

254 governance was defined by reviewing literature, reports and information bulletins of the

255 national food safety agencies (FASFC in Belgium; Mattilsynet in Norway; AESAN in Spain)

256 and produce organisations involved in the enforcement (Vegaplan in Belgium; Matmerk in

257 Norway; Proexport in Spain), and by interviewing twenty-seven (27) experts (nine per case

258 study). Two experts for the Spanish case were from a research institute (S01 and S02), one

259 from a produce organisation (S03), and six from companies (S04-S09). One expert for the

260 Norwegian case was from the national food safety authority (N10), one from a produce

261 organisation (N11), and six from companies (N13-N18). Two experts for the Belgian case

262 were from sector organisations (B19 and B20), one from the organisation of the auctions

263 (B21), and six from companies (B22-B27).

264 Data about the FSMS was collected with the diagnostic tool at twenty-seven (27) leafy greens

265 production companies. The producers have been approached randomly to represent typical

11
266 companies in characteristic supply chains in each of the regions: eleven (11) in Spain, and

267 eight (8) in Belgium and Norway each. Twenty-three (23) companies in the primary

268 production sector of leafy greens responded and participated in our study (Table 1). The

269 response rates per country case were as follows: 11/11 in Spain, 6/8 in Norway, and 6/8 in

270 Belgium. We have ceased approaching new companies because the incremental learning

271 between theory development and data analysis showed to be minimal (Eisenhardt, 1989) due

272 to the high recurrence in the data collected with the diagnostic instrument. Data from the

273 primary production companies was collected by using the diagnostic tool in two ways:

274 interviews with the quality assurance manager or company owner for about 1½ hour, and a

275 workshop with companies in Spain in February 2012.

276

277 Characteristics of the agro-climatic, market and public policy environments

278 Details about the agro-climatic (climate zone and way of production) and market environment

279 (size of companies, type of supply chain) of the companies that participated in our study are

280 presented in Table 1. The companies in Spain have been producing open field in cold semi-

281 arid (Mediterranean) climate. They have been mostly big, export-oriented and certified

282 against many private quality standards. Production in Norway was both open field and in

283 greenhouses, in humid continental climate. Primary producers have been mostly small,

284 producing only for the local market (both supermarkets and processing companies) and they

285 have applied public national standards such as Quality System for Agriculture (KSL), Nyt

286 Norge and Debio. The local producers have been protected by the public policy in Norway

287 through direct subsidy transfers and seasonal import tariffs (Tennbakk, 2004; NC, 2013).

288 Companies in Belgium have been producing open field and in greenhouses, in maritime

289 temperate climate. They were micro family-owned farms, supplying to the local market and

290 exporting to the neighbouring countries via an auction. They have been certified against the

12
291 national self-checking system (SCS), the industrial national standard Integral Chain Quality

292 Control (ICQC), as well as for GlobalGAP. Companies in both Spain and Belgium have been

293 operating under the public policy environment of the EU, which subsidises primary

294 production (Greer, 2005) and puts tariffs on products imported to the EU (EC, 2013). The

295 subsidies are linked to size of land and cross-compliance to standards for environmental

296 protection and food safety, although, no criteria is given for measuring the latter (Amores and

297 Contreras, 2009). The subsidies are granted according to the historical references of a country

298 and farm, which with time led to more benefit for the bigger land owners and certain groups

299 of producers (Greer, 2005).

300

301 Characteristics of the food safety governance

302 Table 3 shows the results from the analysis of the food safety governance, as a result from

303 public and private enforcement, which makes it also a part of the ‘broad context’ in which

304 companies operate.

305 In Spain the enforcement strategy has been based on market self-regulation, as the companies

306 have been following many voluntary private standards and retailer’s quality assurance

307 schemes (Tables 1 and 2). On-site audits have been performed by different third-parties, both

308 random and scheduled, but a national standard has not been introduced.

309 The enforcement strategy in Norway has been identified as generally following the traditional

310 approach of direct command and control intervention by the state, because companies have

311 been following the national public standards (Tables 1 and 2). Still, a sign of co-regulation has

312 been observed in the joint management of the standards by state and industry. The national

313 food safety authority (Mattilsynet) has been responsible for regulating food safety, including

314 legislation related to the production and distribution of food. A government-owned food

315 safety standard called KSL Matmerk (Quality Systems in Farming – Quality Mark) has been

13
316 set for the primary production sector. The standard has been managed by an independent,

317 publicly supported organisation, founded by the government, and governed by a board of

318 representatives of primary producers, retailers and processors. KSL is a baseline standard,

319 meaning that it is based on legislation. It is also a pre-requisite for the Nyt Norge label, which

320 claims that only Norwegian ingredients have been used in the product. Audits have been

321 based on yearly self-reporting, and on-site visits on a risk-based principle (Matmerk, 2013).

322 Negative information has been provided to the consumers through ‘naming and shaming’ of

323 the companies which have exceeded the maximum residue limits (MRLs) (Riksrevisjonen,

324 2012). The product sampling for pesticides has been done in a risk-based principle by the

325 retailers or by the processing companies, and as a result the focus has been mostly on

326 imported produce rather than on the locally grown one (N12). Microbiological sampling of

327 the water source has been foreseen in the KSL standard.

328 Due to the use of public and private standards, and their joint management by the sector

329 organisation, we have typified the enforcement strategy in Belgium as following the

330 principles of co-regulation (Tables 1 and 2). Primary production companies in Belgium have

331 to comply with the law for self-regulation and implement a self-checking system (FASFC,

332 2003). Sector associations have prepared guidelines for the implementation of the self-

333 checking system (SCS), and companies have been stimulated to get certification to the SCS,

334 as this leads to reduction of the annual fee to the agency and the number of inspections

335 (Jacxsens et al., 2013). Furthermore, a chain-wide industrial standard called ICQC (Integral

336 Chain Quality Control) with enhanced requirements have been initiated by several leading

337 producers and processors (Mondelaers and Van Huylenbroeck, 2008). SCS and ICQC have

338 been jointly managed by a sector association, which is responsible for updating and training

339 the auditors (Vanhaverbeke et al., 2008). Next to these national standards, GlobalGAP has

340 been also widely implemented by the companies, as a certification has been required for

14
341 export (B22-27). The audits against GlobalGAP may be combined with those against SCS and

342 ICQC, and have been done by third-party accredited auditors.

343

344 Food safety management at companies

345 FSMS context

346 The frequency distributions in Table 3 show the results for the narrow ‘FSMS context’

347 indicators for all companies in the study. The indicators for product and production, and some

348 of the chain characteristics scored similarly for all the companies. This can be explained by

349 the fact that all companies were growing the same type of product, buying their supplies

350 locally, and following the same hygiene and food safety EU legislation.

351 The modes in Table 3 have been calculated to compare the results for the ‘FSMS context’

352 indicators between the companies in the Spanish, Norwegian and Belgian case study. The

353 biggest differences have been observed in the organisational characteristics. Spanish

354 companies had central quality departments, with a special team responsible for quality and

355 safety at primary production (S04-S09), which was depicted in the results from the diagnostic

356 instrument with the low risk (situation 1) for the indicators about technical personnel (CO9),

357 management commitment (CO12) and formalization (CO14). Attention was put also on the

358 training and involvement of the workers. Upon hiring, Spanish companies were setting

359 requirements on previous experience and providing basic food safety training (CO11=2,

360 moderate risk). They were also stimulating their employees to discuss and provide

361 suggestions for improvement via their group managers (CO13=2, moderate risk).

362 In Norwegian companies, a technical person was present but with no specific knowledge on

363 food safety (CO9=2), and companies did not have special quality policy. However, workers

364 have been stimulated to provide suggestions via their group managers (CO13=2). Belgian

365 companies commonly did not have any technical person with knowledge on food safety and

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366 were relying on common cultivation practices (CO9=3, high risk), and their workers showed

367 low involvement (CO13=3). Moreover, no requirements have been put on previous

368 experience or education, and no training has been provided for the (seasonal) workers

369 (CO11=3).

370

371 FSMS activities

372 Table 4 shows the frequency distributions of the scores for the indicators of the FSMS

373 activities. The indicators for control activities such as design of equipment and facilities

374 (PM24), maintenance program (PM25), storage facilities (PM26), supplier control (PM31),

375 water control (PM34), measuring equipment (MS42) and corrective actions (MS43) scored as

376 3 (average situation) for most of the companies. This indicated the use of best available

377 equipment and methods, and following standards and guidelines common for the sector.

378 However, the indicators for packaging (PM30), partial physical intervention (IM36), and

379 analytical methods for microorganisms (MS38) and pesticide residues (MS39) showed more

380 polarized results. They were either not applied (score 1), or at average (3) to advanced

381 situation (4). Regarding assurance activities, most companies have been regularly using

382 feedback information from the control activities for introducing improvements, but rarely

383 documenting the changes (SR53=3). Majority of the companies have been keeping records

384 (DA59=3) of the critical product and production parameters (such as, pesticide type and time

385 of application).

386 The modes in Table 4 have been calculated to compare the results for the indicators of the

387 FSMS activities between the companies in the Spanish, Norwegian and Belgian case study.

388 The Spanish companies showed higher scores for their control and assurance activities

389 (mostly 3 and 4), compared to companies in Belgium and Norway. Core control activities

390 such as personal hygiene requirements (PM28), programs for organic fertilisers (PM32) and

16
391 pesticide management (PM33), water control (PM34), irrigation method (PM35) and supplier

392 selection (PM31) scored as 3 (average) and 4 (advanced situation), which revealed activities

393 that have been following the ‘best practices’ in the sector, and have been adapted and tested

394 for the specific production practices. Indicators of assurance activities again scored higher in

395 Spain, where companies were actively following changes in requirements from stakeholders

396 and implementing the necessary changes (SR52=4). The companies scored high on

397 verification of people (VE56=4) and equipment (VE57=3), and validation (SR54, 55=3).

398 Norwegian companies scored lower than the Spanish - mostly scores 2 and 3 (Table 4).

399 Several crucial control activities, such as personal hygiene control (PM28), storage facilities

400 (PM26), sanitation program (PM27), incoming material control (PM29), and corrective

401 actions (MS43) scored 3. These results represent situations when activities are designed by

402 following standards or guidelines. Norwegian companies demonstrated good insights into

403 actual operation of their control activities, because of the advanced and average situations for

404 availability of procedures (OC44=4), hygiene performance of equipment (OC46=3), storage

405 capacity (OC47=3), and measuring equipment performance (OC50=3). Assurance activities

406 scored as basic situation due to ad-hoc validation activities (VA54, VA55=2), which have

407 been performed by the owner or managers, based on historical knowledge.

408 The companies in Belgium scored the lowest in our study (Table 4). Many of their core

409 control activities, such as sanitation program (PM27), personal hygiene requirements (PM28),

410 incoming material control (PM29), irrigation method (PM35), and corrective actions (MS43)

411 have been designed according to own experience and knowledge (score 2). They had also

412 limited insight into actual operation of their control activities and had to deal with regular

413 problems, as all indicators scored 1 (low) and 2 (basic). Moreover, validation activities have

414 been lacking (VA54, VA55=1), and verification has been basic, performed ad-hoc, not

415 documented, only by checking the presence but not analysing (VE56, 57=2), which calls

17
416 under question the effectiveness of the control activities. Documentation was unsystematic

417 and ad-hoc (score 2), compared to the structured and easily available documentation in

418 Norway (score 3) and Spain (score 4).

419

420 FSMS output

421 Table 5 shows the frequency distributions of the scores for the indicators of the FSMS output,

422 and the respective modes that were calculated to compare the results between the companies

423 in the Spanish, Norwegian and Belgian case study. Spanish companies received audits by

424 many third parties, including audits against GlobalGAP, which is comparable to the situation

425 in Belgium, but contrasting to the audits from only one third party in Norway (that is,

426 Matmerk). The Spanish leafy greens companies have been able to show evidence of their

427 good system output to the stakeholders as they have been performing structured sampling for

428 microorganisms and pesticide residues (SA65, SA67, SA68=4; SA66=3). This was differing

429 from the lower results in Norway, where no samples were taken (MS38, MS39, MS40,

430 MS41=1). In Belgium, a structured sampling for pesticide residues was in place, organised on

431 a sector level or as part of sampling plans of an auction or trader (SA67=3). Sampling for

432 microorganisms in Belgian companies has been done only occasionally by the auctions or

433 traders (like, in the case of a presumed outbreak in the fresh produce sector; experts B22, B25

434 and B26).

435

436 Discussion

437 The objective of this explorative study was to gain insight into the ‘broad context’, its sub-

438 systems and the relationships between them, and the mechanisms through which they can

439 directly influence the narrow ‘FSMS context’, FSMS activities and their system output. We

440 have defined the ‘broad context’ as consisting of agro-climatic, market and public policy

18
441 environment, and food safety governance. Moreover, we have observed that these sub-

442 systems interact with each other and can also indirectly influence the ‘FSMS context’, FSMS

443 activities and their output.

444

445 Interactions within the ‘broad context’

446 Case studies in leafy greens production were conducted in three regions: Murcia (Spain), Lier

447 (Norway) and Flanders (Belgium). Markets and supply chains differ in those countries.

448 Spanish companies operate in a favourable agro-climatic environment, which also positively

449 affected the market. Actually, about half of the lettuce in the EU is grown in Spain

450 (FAOSTAT, 2013), and Murcia is the biggest producing region that provides about 70% of

451 exported lettuce (Lario et al., 2006). The opportunity for year-round supply has attracted

452 investors from the northern EU member states (i.e., companies in UK, Belgium, the

453 Netherlands) (Lario et al., 2006). The export market grew, which led to expansion of the

454 companies. Several of the Spanish companies even invested in production fields on higher

455 altitudes, which allowed them to produce all year around (even in the hot summer months),

456 and thus to control the agro-climatic environment. The market also governed the food safety,

457 as stringent private standards have been the major food safety and quality enforcement

458 strategy applied to the companies.

459 In the case of Norwegian companies, however, the producers are small and these represent

460 the majority of the farmers in the country (Richards et al., 2013). The unfavourable agro-

461 climatic environment makes the local agriculture non-competitive with the world market

462 prices, which was the reason for the introduction of direct transfers and tariffs on import

463 products in the public policy, in order to secure the incomes of the primary producers

464 (Tennbakk, 2004). A public baseline national standard (KSL), and other national standards

465 promoting local production (Nyt Norge, Debio) have been introduced to induce compliance

19
466 by the companies to quality and safety (Borgen, 2009; Richards et al., 2013). The Norwegian

467 fresh produce chain is heavily concentrated in its retail part where four retailer chains have

468 99% of the market, which makes it among the most concentrated in Europe (Jervell and

469 Borgen, 2004; Fuchs et al., 2009). The production is marketed through cooperatives, which

470 are owned by the primary producers and serve as their joint agents (Tennbakk, 2004; Richards

471 et al., 2013). The cooperatives have dominating market position, and long-term contracts with

472 the biggest retailers and wholesalers (NOU, 2011). No market standards have been imposed to

473 the farmers (such as GlobalGAP), which is linked to the strong power position of the local

474 farm-owned cooperatives promoted by the state (Richards et al., 2013).

475 The Belgian market is highly fragmented, with many micro family-owned companies

476 (Vanhaverbeke et al., 2008). A public national self-checking standard is introduced to guide

477 food companies in setting and operating their FSMS (FASFC, 2003). The market is organised

478 around cooperative auctions, which are common marketplaces where growers and wholesalers

479 or retailers meet and an auction clock determines the price of goods (Mondelaers and Van

480 Huylenbroeck, 2008). From these auctions the production can be distributed to either local

481 market or export, and thus certification against both the industrial national ICQC standard,

482 and the international GlobalGAP is required from the farmers (Mondelaers and Van

483 Huylenbroeck, 2008). To ease the certification of all these small farmers, a sector organisation

484 is managing both the public and the private national standard. Moreover, audit against both

485 national standards or together with GlobalGAP can be combined.

486

487 Impact of the ‘broad context’ on the narrow ‘FSMS context’

488 The ‘broad context’ can be linked to the differences in the narrow context of the FSMS, and

489 especially the organisational characteristics of the companies. To answer to the many market

490 requirements and standards, Spanish companies have established food quality and safety

20
491 policy, and central quality departments, with technical staff to support primary production.

492 They have invested in training of personnel and establishing of strict procedures. The pressure

493 from the market was more lax in Norway, food safety governance was publicly led and

494 companies have shown not to have a special quality policy and less technical staff. The small

495 family-owned farms in Belgium experienced difficulties in acquiring technical expertise,

496 educating and motivating the temporary workers. Nevertheless, in both Norway and Belgium,

497 general procedures and information systems have been established, which could be associated

498 with the wide-spread certification against the national baseline standards.

499

500 Impact of the ‘broad context’ on FSMS activities

501 Differences in the ‘broad context’ can also relate to the actual implementation of the FSMS in

502 the three selected case studies in Spain, Norway, and Belgium. Spanish companies heavily

503 invested in equipment and methods, and assured the continuous incorporation of technical

504 innovations (e.g. new crop varieties, drip irrigation, harvesting methods), which was

505 demonstrated by the advanced control activities in our study. Assurance activities, which aim

506 at providing evidence that control activities and the FSMS as a whole are effective and

507 working well, also showed average to advanced levels. This is in line with reports indicating

508 that the leafy greens sector in Murcia is among the best performing in Spain and in Europe

509 (Lario et al., 2006). The sector is characterised by high supply chain integration as many

510 primary production companies are owned by the traders, and close relations are maintained

511 with suppliers of seeds and other inputs (Lario et al., 2006). Norwegian companies, however,

512 strictly adhere to the national standards, as the control activities in our study mostly scored as

513 average situation. The knowledge-intensive assurance activities, however, have been mostly

514 based on own knowledge and experience (basic situation). This is in line with a study done in

515 Japanese dairy companies, which also strictly followed national standards but scored lower

21
516 for assurance activities (Sampers et al., 2012). Belgian companies showed the lowest scores,

517 with basic FSMS activities, despite the wide certification against three quality assurance

518 standards. They also had little insight about actual operation of the control activities.

519 Validation activities have been lacking, and verification of people and equipment has been

520 done only ad-hoc. However, several activities for which companies received support from the

521 sector organisation and the auctions scored as average, like for instance the translation of

522 external requirements (SR52) and systematic use of feedback information (SR53).

523

524 Impact of the ‘broad context’ on FSMS output

525 Differences in the ‘broad context’ have been clearly reflected in the results of the FSMS

526 output. Spanish companies have had very detailed information about all the indicators of the

527 FSMS output. They have been audited against several quality assurance standards, because

528 these have been required by the market. Companies have been also doing extensive sampling

529 for microorganisms and pesticide residues, and systematically registering non-conformities

530 and complaints. This information has been required by their clients to prove the good

531 functioning of their FSMS.

532 The situation in Norwegian companies has been rather different. The audits of the companies

533 again the national public KSL standard have been mostly based on self-auditing and self-

534 reporting. No sampling was done for neither microorganisms nor pesticide residues. Actually

535 the situation in Norway is unique, because the country never had a big food scandal, and the

536 wide public believes in the safety of local produce (Halkier and Holm, 2006; Kjaernes et al.,

537 2007). This trust was demonstrated also in our study by the lax inspections and lack of

538 sampling.

539 The family-owned micro companies in Belgium have received support in acquiring

540 information about their output by both market and public sector. Auctions have regularly

22
541 taking and analysing samples for pesticide residues. The sampling information has been

542 communicated to the sector organisation, which further coordinated the process of applying

543 corrective actions upon non-conformities. However, no systematic microbiological sampling

544 was performed yet.

545

546 The food safety governance

547 The governance of food safety, which aims at inducing compliance to food safety

548 requirements by the companies, forms an integral part of the ‘broad context’. The EU has

549 promoted the co-regulation and shift of responsibility towards private and public-private

550 hybrid forms (Ménard and Valceschini, 2005). The approaches observed in our case studies,

551 varied between the member states, ranging between market self-regulation (Spain), co-

552 regulation (Belgium) and state-controlled regulation (Norway). These findings feed the

553 theories about traditions of public policy and governance (Bevir et al., 2003a, b). Spain has

554 been following the Napoleonic tradition of central state and many regional organs responsible

555 for the equal implementation of the policy across the country (Peters, 2008). This tradition has

556 however eroded into regionalisation with significant differences between the regions and

557 involvement of market mechanisms (Torres and Pina, 2004; Parrado, 2008). The strong role

558 of the state has been typical for the Nordic countries, although some new ideas have been also

559 adapted (Christensen, 2003). The latter was observed in the management board of the KSL

560 standard, consisting of representatives from both government and industry. The Belgium

561 tradition has been embedded in the neo-corporatist democracy, which is based on consensus,

562 compromise, and representation by a few well-organised groups that are recognised by the

563 state (Kickert, 2002).

564 The results from the three cases raise questions about independence, consistency, and

565 transparency of the food safety audits, enforcement of the standards, and the role of the public

23
566 sector. Enforcement often relies on third-party private audits, like in the Spanish and Belgian

567 case. However, these have been criticised for their ineffectiveness and partiality, and for

568 providing only a snap-shot picture of the food production (Albersmeier et al., 2009; Powell et

569 al., 2013). In some cases, less attention is paid to primary production of fresh produce because

570 of the risk-based character of the food audits and inspections and limited time and resources.

571 This was observed in the Norwegian case. Audits, inspections and monitoring should be

572 independent, objective, consistent and transparent (Powell et al., 2013), which provides room

573 for the public sector to control and intervene upon doubt or breach of these principles.

574 Education and training also face limitations due to inconsistent programs, lack of follow up

575 and evaluation of the effectiveness to change behaviour (Egan et al., 2007; Jevšnik et al.,

576 2008; Soon and Baines, 2012). Instead, studies have stressed the importance of establishing

577 and reinforcing a food safety culture with shared values by the management and the workers

578 (Griffith et al., 2010; Powell et al., 2011).

579

580 Methodological considerations

581 This research explored about the role of the ‘broad context’ in a country and sector on the

582 status of FSMS on a company level. It used three different case studies to extend existing

583 theories about factors influencing design and operation FSMS in companies (Luning et al.,

584 2008; 2009; Jacxsens et al., 2010b; Luning et al., 2011b). Further studies should consider in

585 their design the ceteris paribus condition by keeping constant some of (the elements in) the

586 sub-systems of the ‘broad environment’ and thus define the direct and indirect influences and

587 possibly their magnitude on FSMS.

588 Last but not least, this study was a further validation of the robustness of the developed

589 diagnostic tool for assessing FSMS in the fresh produce sector in view of their narrow ‘FSMS

590 context’ (Kirezieva et al., 2013a; 2013b). The tool provided consistent results and

24
591 demonstrated ability to detect differences between FSMS of companies in different contexts,

592 which supported the external validity of the tool. However, the validation of the tool should

593 address also the criterion validity, which compares with other measures or outcomes already

594 held to be valid (de Vaus, 2001). A comparison with microbial sampling data from the same

595 companies is on-going and the results will be published in the near future.

596

597 Conclusion

598 Food companies operate their FSMS in a complex context. On the one hand, during setting

599 and operating their FSMS activities, companies need to consider factors in the ‘FSMS

600 context’, such as risk of product and production, and limitations and opportunities of their

601 organisation and chain characteristics. On the other hand, in this paper we have demonstrated

602 that the ‘FSMS context’, the implemented FSMS and their output, are influenced by the

603 ‘broad context’ shaped by food safety governance, agro-climatic, market, and public policy

604 environments. The latter involved both public and private actors. Although all the companies

605 in our case studies have been operating under the same EU food legislation, the approaches to

606 food safety governance have varied. They have ranged between market self-regulation, co-

607 regulation, and state regulation, which implies a link to the different governance traditions in

608 the three European countries, and explaining the shift in the role of the state.

609 The companies operating in favourable ‘broad context’, including favourable climate, big

610 companies in integrated market, and stringent standards as a result of market self-regulation,

611 have demonstrated advanced FSMS, good information about the output and supporting

612 organisational characteristics. The FSMS of the companies that were operating in less

613 favourable ‘broad context’, either in fragmented market with small companies or in less

614 favourable climate, have demonstrated less mature FSMS. However, the national state

615 intervention via public policy interventions (subsidies and import tariffs) and baseline food

25
616 safety standards have supported domestically supplying companies and they realised average

617 FSMS, based on ‘best available’ knowledge and experience. This was not the case with the

618 small companies operating in fragmented market, which demonstrated basic FSMS and lack

619 of support from organisational characteristics. These companies have been dealing with both

620 domestic and export market, certified against both private and public standards. This mixture

621 or standards and requirements has proved difficult for the implementation capabilities of

622 small farmers.

623 As a conclusion, we postulate that the FSMS output is a function of the ‘broad context’, the

624 narrow ‘FSMS context’, and activities in the FSMS.

625 FSMS output = ƒ (Broad context; FSMS context; FSMS activities)

626 The combination of tools used in this study enables analysis of the food safety management in

627 a country and sector from a systems perspective, including interactions and relationships

628 between and within the FSMS and the context in which they operate. The outcome of the

629 analysis contributes to understanding the effectiveness of the current systems for food safety

630 management. The approach can be further elaborated to analyse the most important

631 determinants of the agro-climatic, market, public policy environment, and food safety

632 governance that influence the implementation of food safety management systems in

633 companies.

634

635 Acknowledgements

636 This research has received funding from the European Community’s Seventh Framework

637 Program (FP7) under grant agreement no 244994 (project Veg-i-Trade ‘Impact of Climate

638 Change and Globalization on Safety of Fresh Produce – Governing a Supply Chain of

639 Uncompromised Food Sovereignty’; http://www.veg-i-trade.org). We would like to thank the

640 experts from Belgium, Norway and Spain, and the companies that participated in the study.

26
641 Our deepest gratitude goes to Ana Allende, Gro Johannessen, Irene Castro Ibañez, Kevin

642 Holvoet, Maria I. Gil, Nina Heiberg and Vyara Vyagova for their support during the data

643 collection.

27
644 References
645 Abhilash, P.C., Singh, N., 2009. Pesticide use and application: An Indian scenario. Journal of Hazardous
646 Materials 165, 1-12.
647 Altmann, M., Wadl, M., Altmann, D., Benzler, J., Eckmanns, T., Krause, G., Heidein, M., an der, 2011.
648 Timeliness of surveillance during outbreak of Shiga toxin–producing Escherichia coli infection,
649 Germany, 2011. Emerging Infectious Diseases 17.
650 Amores, A.F., Contreras, I., 2009. New approach for the assignment of new European agricultural subsidies
651 using scores from data envelopment analysis: Application to olive-growing farms in Andalusia (Spain).
652 European Journal of Operational Research 193, 718-729.
653 Arvanitoyannis, I.S., Choreftaki, S., Tserkezou, P., 2005. An update of EU legislation (Directives and
654 Regulations) on food-related issues (Safety, Hygiene, Packaging, Technology, GMOs, Additives,
655 Radiation, Labelling): presentation and comments. International Journal of Food Science & Technology
656 40, 1021-1112.
657 Baert, L., Mattison, K., Loisy-Hamon, F., Harlow, J., Martyres, A., Lebeau, B., Stals, A., Van Coillie, E.,
658 Herman, L., Uyttendaele, M., 2011. Review: Norovirus prevalence in Belgian, Canadian and French
659 fresh produce: A threat to human health? International Journal of Food Microbiology 151, 261-269.
660 Berger, C.N., Sodha, S.V., Shaw, R.K., Griffin, P.M., Pink, D., Hand, P., Frankel, G., 2010. Fresh fruit and
661 vegetables as vehicles for the transmission of human pathogens. Environmental Microbiology 12, 2385-
662 2397.
663 Bernauer, T., Caduff, L., 2004. European food safety: Multilevel governance, re-nationalization, or
664 centralization?, in: Ansell, C., Vogel, D. (Eds.), What's the Beef? The Contested Governance of
665 European Food Safety. Cambridge, MA: MIT, Cambridge, United Kingdom, pp. 81-95.
666 Bevir, M., Rhodes, R.A.W., Weller, P., 2003a. Comparative governance: prospects and lessons. Public
667 Administration 81, 191-210.
668 Bevir, M., Rhodes, R.A.W., Weller, P., 2003b. Traditions of governance: interpreting the changing role of the
669 public sector. Public Administration 81, 1-17.
670 Caduff, L., Bernauer, T., 2006. Managing Risk and Regulation in European Food Safety Governance. Review of
671 Policy Research 23, 153-168.
672 Cerroni, S., Notaro, S., Shaw, W.D., 2013. How many bad apples are in a bunch? An experimental investigation
673 of perceived pesticide residue risks. Food Policy 41, 112-123.
674 Chen, C., Qian, Y., Chen, Q., Tao, C., Li, C., Li, Y., 2011. Evaluation of pesticide residues in fruits and
675 vegetables from Xiamen, China. Food Control 22, 1114-1120.
676 Cotty, P.J., Jaime-Garcia, R., 2007. Influences of climate on aflatoxin producing fungi and aflatoxin
677 contamination. International Journal of Food Microbiology 119, 109-115.
678 de Vaus, D., 2001. Tools for Research Design, in: de Vaus, D. (Ed.), Research Design in Social Research. SAGE
679 Publications, London.
680 EC, 2013. Commission Implementing Regulation (EU) No 1001/2013 of 4 October 2013 amending Annex I to
681 Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common
682 Customs Tariff, in: Commission, E. (Ed.).
683 Eijlander, P., 2005. Possibilities and constraints in the use of self-regulation and co-regulation in legislative
684 policy: Experiences in the Netherlands - Lessons to be learnt for the EU? Electronic Journal of
685 Comparative Law 901, 1-8.
686 Eisenhardt, K.M., 1989. Building Theories from Case Study Research. The Academy of Management Review
687 14, 532-550.
688 Fallah, A.A., Pirali-Kheirabadi, K., Shirvani, F., Saei-Dehkordi, S.S., 2012. Prevalence of parasitic
689 contamination in vegetables used for raw consumption in Shahrekord, Iran: Influence of season and
690 washing procedure. Food Control 25, 617-620.
691 FAO, 2008a. Climate-related transboundary pests and diseases, Technical background document from the Expert
692 Consultation held on 25 to 27 February 2008. Food and Agriculture Organisation of the United Nations.
693 FAO, 2008b. Microbiological hazards in fresh leafy vegetables and herbs, Microbiological Risk Assessment
694 Series. Food and Agriculture Organisation of the United Nations.
695 FASFC, 2003. Koninklijk Besluit van 14 november 2003 betreffende autocontrole, traceerbaarheid en
696 meldingsplicht in de voedselketen., in: Chain, F.A.f.t.S.o.t.F. (Ed.).
697 Fearne, A., Garcia Martinez, M., 2005. Opportunities for the coregulation of food safety: Insights from the
698 United Kingdom. Choices: The Magazine of Food, Farm, and Resource Issues 20, 109-116.
699 Fotopoulos, C.V., Psomas, E.L., Vouzas, F.K., 2010. ISO 9001:2000 implementation in the Greek food sector.
700 TQM Journal 22, 129-142.
701 Fulponi, L., 2006. Private voluntary standards in the food system: The perspective of major food retailers in
702 OECD countries. Food Policy 31, 1-13.

28
703 Gajraj, R., Pooransingh, S., Hawker, J.I., Olowokure, B., 2011. Multiple outbreaks of Salmonella braenderup
704 associated with consumption of iceberg lettuce. International Journal of Environmental Health Research
705 22, 150-155.
706 Galt, R.E., 2008. Beyond the circle of poison: Significant shifts in the global pesticide complex, 1976–2008.
707 Global Environmental Change 18, 786-799.
708 Galt, R.E., 2010. Scaling Up Political Ecology: The Case of Illegal Pesticides on Fresh Vegetables Imported into
709 the United States, 1996–2006. Annals of the Association of American Geographers 100, 327-355.
710 Garcia Martinez, M., Fearne, A., Caswell, J.A., Henson, S., 2007. Co-regulation as a possible model for food
711 safety governance: Opportunities for public–private partnerships. Food Policy 32, 299-314.
712 Ge, C., Lee, C., Lee, J., 2012. The impact of extreme weather events on Salmonella internalization in lettuce and
713 green onion. Food Research International 45, 1118-1122.
714 Greer, A., 2005. Agricultural policy in Europe. Manchester University Press, Manchester, United Kingdom.
715 Greig, J.D., Todd, E.C.D., Bartleson, C.A., Michaels, B.S., 2007. Outbreaks Where Food Workers Have Been
716 Implicated in the Spread of Foodborne Disease. Part 1. Description of the Problem, Methods, and
717 Agents Involved. Journal of Food Protection 70, 1752-1761.
718 Halkier, B., Holm, L., 2006. Shifting responsibilities for food safety in Europe: An introduction. Appetite 47,
719 127-133.
720 Hampton, P., 2004. Reducing administrative burdens: Effective inspection and enforcement, The Hampton
721 Review – Final Report. Her Majesty’s Treasury, Norwich, UK.
722 Havinga, T., 2006. Private regulation of food safety by supermarkets. Law & Policy 28, 515-533.
723 Henson, S., 2008. The role of public and private standards in regulating international food markets. Journal of
724 International Agricultural Trade and Development 4, 63-81.
725 Hjorth, K., Johansen, K., Holen, B., Andersson, A., Christensen, H.B., Siivinen, K., Toome, M., 2011. Pesticide
726 residues in fruits and vegetables from South America – A Nordic project. Food Control 22, 1701-1706.
727 Humphrey, J., 2005. Shaping value chains for development: Global value chains in agribusiness, in:
728 Development, F.M.f.E.C.a. (Ed.). Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ)
729 GmbH, Eschborn, Germany.
730 Jacxsens, L., Kirezieva, K., Luning, P.A., Ingelrham, J., Diricks, H., Uyttendaele, M., 2013. Measuring
731 Microbial Food Safety Output and Comparing Self-Checking Systems of Food Business Operators in
732 Belgium. Food Control in press.
733 Jacxsens, L., Luning, P.A., Marcelis, W.J., van Boekel, T., Rovira, J., Oses, S., Kousta, M., Drosinos, E., Jasson,
734 V., Uyttendaele, M., 2011. Tools for the performance assessment and improvement of food safety
735 management systems. Trends in Food Science & Technology 22, Supplement 1, S80-S89.
736 Jacxsens, L., Luning, P.A., van der Vorst, J.G.A.J., Devlieghere, F., Leemans, R., Uyttendaele, M., 2010a.
737 Simulation modelling and risk assessment as tools to identify the impact of climate change on
738 microbiological food safety – The case study of fresh produce supply chain. Food Research
739 International 43, 1925-1935.
740 Jacxsens, L., Uyttendaele, M., Devlieghere, F., Rovira, J., Gomez, S.O., Luning, P.A., 2010b. Food safety
741 performance indicators to benchmark food safety output of food safety management systems.
742 International Journal of Food Microbiology 141, Supplement, S180-S187.
743 Kirezieva, K., Jacxsens, L., Uyttendaele, M., Van Boekel, M.A.J.S., Luning, P.A., 2013a. Assessment of Food
744 Safety Management Systems in the global fresh produce chain. Food Research International 52, 230-
745 242.
746 Kirezieva, K., Jacxsens, L., van Boekel, M.A.J.S., Luning, P.A., 2014. Towards strategies to adapt to pressures
747 on safety of fresh produce due to climate change. Food Research International.
748 Kirezieva, K., Nanyunja, J., Jacxsens, L., van der Vorst, J.G.A.J., Uyttendaele, M., Luning, P.A., 2013b. Context
749 factors affecting design and operation of food safety management systems in the fresh produce chain.
750 Trends in Food Science & Technology 32, 108-127.
751 Kjaernes, U., Harvey, M., Warde, A., 2007. Trust in Food. Palgrave Macmillan, Basingstoke.
752 Konecka-Matyjek, E., Turlejska, H., Pelzner, U., Szponar, L., 2005. Actual situation in the area of implementing
753 quality assurance systems GMP, GHP and HACCP in Polish food production and processing plants.
754 Food Control 16, 1-9.
755 Lario, N.A., Espallardo, M.H., Zamudio, M.Á.F., 2006. Análisis del sector de hortalizas, Plan estratégico del
756 sector agroalimentario de la región de Murcia. Universidad Politecnica de Cartagena; Consejeria de
757 Agricultura y Agua; Universidad de Murcia.
758 Liu, C., Hofstra, N., Franz, E., 2013. Impacts of climate change on the microbial safety of pre-harvest leafy
759 green vegetables as indicated by Escherichia coli O157 and Salmonella spp. International Journal of
760 Food Microbiology 163, 119-128.

29
761 Luning, P.A., Bango, L., Kussaga, J., Rovira, J., Marcelis, W.J., 2008. Comprehensive analysis and
762 differentiated assessment of food safety control systems: a diagnostic instrument. Trends in Food
763 Science & Technology 19, 522-534.
764 Luning, P.A., Jacxsens, L., Rovira, J., Osés, S.M., Uyttendaele, M., Marcelis, W.J., 2011a. A concurrent
765 diagnosis of microbiological food safety output and food safety management system performance:
766 Cases from meat processing industries. Food Control 22, 555-565.
767 Luning, P.A., Kirezieva, K., Hagelaar, G., Uyttendaele, M., Jacxsens, L., 2013. Performance assessment of food
768 safety management systems in animal-based food companies in view of their context characteristics: a
769 European study. Food Control in press.
770 Luning, P.A., Marcelis, W.J., Rovira, J., van Boekel, M.A.J.S., Uyttendaele, M., Jacxsens, L., 2011b. A tool to
771 diagnose context riskiness in view of food safety activities and microbiological safety output. Trends in
772 Food Science &Technology 22, Supplement 1, S67-S79.
773 Luning, P.A., Marcelis, W.J., Rovira, J., Van der Spiegel, M., Uyttendaele, M., Jacxsens, L., 2009. Systematic
774 assessment of core assurance activities in a company specific food safety management system. Trends
775 in Food Science & Technology 20, 300-312.
776 Lynch, M.F., Tauxe, R.V., Hedberg, C.W., 2009. The growing burden of foodborne outbreaks due to
777 contaminated fresh produce: risks and opportunities. Epidemiology and Infection 137, 307-315.
778 Matmerk, 2013. http://matmerk.no/.
779 May, P., Burby, R., 1998. Making Sense Out of Regulatory Enforcement. Law & Policy 20, 157-182.
780 Mensah, L.D., Julien, D., 2011. Implementation of food safety management systems in the UK. Food Control 22,
781 1216-1225.
782 Mondelaers, K., Van Huylenbroeck, G., 2008. Dynamics of the retail driven higher end spot market in fresh
783 food. British Food Journal 110, 474-492.
784 NC, 2013. Norwegian Customs Tariff, in: Customs, N. (Ed.). Norwegian Customs, Oslo, Norway.
785 Osés, S.M., Luning, P.A., Jacxsens, L., Santillana, S., Jaime, I., Rovira, J., 2012. Food safety management
786 system performance in the lamb chain. Food Control 25, 493-500.
787 Patz, J.A., Campbell-Lendrum, D., Holloway, T., Foley, J.A., 2005. Impact of regional climate change on human
788 health. 438, 310-317.
789 Pettigrew, A., 1988. The Management of Strategic Change. Blackwell, Oxford, United Kingdom.
790 Powell, D.A., Jacob, C.J., Chapman, B., 2009. Produce in Public: Spinach, Safety, and Public Policy, Microbial
791 Safety of Fresh Produce. Wiley-Blackwell, pp. 369-384.
792 Renn, O., Ortleb, J., Benighaus, L., Benighaus, L., 2011. Risks, in: Pechan, P., Renn, O., Watt, A., Pongratz, I.
793 (Eds.), Safe or Not Safe. Springer, pp. 1-41.
794 Richards, C., Bjørkhaug, H., Lawrence, G., Hickman, E., 2013. Retailer-driven agricultural restructuring—
795 Australia, the UK and Norway in comparison. Agriculture and Human Values 30, 235-245.
796 Riksrevisjonen, 2012. Riksrevisjonens undersøkelse av Mattilsynet, in: Kosmo, J. (Ed.). Riksrevisjonen, Oslo,
797 Norway.
798 Rouvière, E., Caswell, J.A., 2012. From punishment to prevention: A French case study of the introduction of
799 co-regulation in enforcing food safety. Food Policy 37, 246-254.
800 Sampers, I., Jacxsens, L., Luning, P.A., Marcelis, W.J., Dumoulin, A., Uyttendaele, M., 2010. Performance of
801 Food Safety Management Systems in Poultry Meat Preparation Processing Plants in Relation to
802 Campylobacter spp. Contamination. Journal of Food Protection 73, 1447-1457.
803 Sampers, I., Toyofuku, H., Luning, P.A., Uyttendaele, M., Jacxsens, L., 2012. Semi-quantitative study to
804 evaluate the performance of a HACCP-based food safety management system in Japanese milk
805 processing plants. Food Control 23, 227-233.
806 Serra, T., Zilberman, D., Goodwin, B.K., Hyvonen, K., 2005. Replacement of Agricultural Price Supports by
807 Area Payments in the European Union and the Effects on Pesticide Use. American Journal of
808 Agricultural Economics 87, 870-884.
809 Skyttner, L., 2005. General systems theory: problems, perspectives and practice. World Scientific, Singapore.
810 Spiegel, M.v.d., Luning, P.A., Boer, W.J.d., Ziggers, G.W., Jongen, W.M.F., 2006. Measuring Effectiveness of
811 Food Quality Management in the Bakery Sector. Total Quality Management & Business Excellence 17,
812 691-708.
813 Stephen, B., 2003. Economic Governance and Institutional Dynamics. Oxford University Press, USA.
814 Stuart, D., 2010. Science, standards, and power: New food safety governance in California. Journal of Rural
815 Social Sciences 25, 111-140.
816 Tennbakk, B., 2004. Cooperatives, regulation and competition in Norwegian agriculture. Food Economics - Acta
817 Agriculturae Scandinavica, Section C 1, 232-240.
818 Unnevehr, L.J., Jensen, H.H., 1999. The economic implications of using HACCP as a food safety regulatory
819 standard. Food Policy 24, 625-635.

30
820 Van Boxstael, S., Habib, I., Jacxsens, L., De Vocht, M., Baert, L., Van De Perre, E., Rajkovic, A., Lopez-
821 Galvez, F., Sampers, I., Spanoghe, P., De Meulenaer, B., Uyttendaele, M., 2013. Food safety issues in
822 fresh produce: Bacterial pathogens, viruses and pesticide residues indicated as major concerns by
823 stakeholders in the fresh produce chain. Food Control 32, 190-197.
824 Vanhaverbeke, W., Larosse, J., Winnen, W., 2008. The Flemish frozen-vegetable industry as an example of
825 cluster analysis: Flanders Vegetable Valley in: Hulsink, W., Dons, J.J.M. (Eds.), Pathways to High-tech
826 Valleys and Research Triangles. Springer.
827 Von Bertalanffy, L., 1969. General System Theory: Foundations, Development, Applications. George Braziller
828 Inc.; Revised edition (March 17, 1969)
829 Yapp, C., Fairman, R., 2004. The evaluation of effective enforcement approaches for food safety in SMEs,
830 Unpublished report. King's College London, London, United Kingdom.
831 Yapp, C., Fairman, R., 2006. Factors affecting food safety compliance within small and medium-sized
832 enterprises: implications for regulatory and enforcement strategies. Food Control 17, 42-51.

833

834

835

31
Highlights (for review)

Highlights

 The role of ‘broad context’ in country and sector on FSMS in companies was explored
 Three case studies in leafy greens sectors in Belgium, Norway and Spain were conducted
 It was postulated: FSMS output = ƒ (‘broad context’; company FSMS context; FSMS)
Figure(s)
Click here to download Figure(s): Draft_article_context_20112013_Figure 1.pptx

Broad context at sector/country level

Agro-climatic Market Food safety Public policy

environment environment governance environment

Company level

Narrow FSMS context

Product Production Food Safety
characteristics characteristics FSMS
Management System
output
Organisational Chain (FSMS)
characteristics characteristics

Figure 1
Figure(s)
Enforcement philosophy
Click here to download Figure(s): Draft_article_context_20112013_Figure 2.pptx

Systematic Facilitative

Enforcement strategy

Direct command and Market self-

Co-regulation
control intervention regulation

State/Public Market/Private

Enforcement practices
Standards Audits Sanctions Stimulus

Information
Sampling plans
and education

Food Safety Management

System (FSMS)

FSMS
output

Figure 2
Figure(s)
Click here to download Figure(s): Captions Figures.docx

Figure 1: Conceptual model showing the relationships between the broad context, narrow
FSMS context, FSMS and FSMS output

Figure 2: Theoretical framework to analyse food safety governance. Based on May & Burby
(1998), Unnvehr & Jensen (1999), Martinez, Fearne, Caswell, & Hanson (2007), & Rouvière
& Caswell (2012)
Table(s)
Click here to download Table(s): Draft_article_context_20112013_Table 1.docx

Table 1: Agro-climatic and market characteristics of the companies that participated in the case studies
Company
Climate Production Size Supply chain Enforced standards
code
Spain
S13 cold semi- open field big2 integrated export- GlobalGAP
S14 arid open field big oriented supply GlobalGAP, BRC, IFS, ISO 9000, Producción Integrada
S15 climate1 open field big chain3 GlobalGAP, UNE 155000
S16 open field big GlobalGAP, ISO 9000, ISO 14001, TESCO Nurture
S17 open field big GlobalGAP, ISO 9000
S18 open field big GlobalGAP, ISO 9000, BRC, IFS, TESCO Nurture, Leaf Marque
S19 open field medium GlobalGAP, TESCO Nurture
S20 open field medium GlobalGAP, ISO 9001, Leaf Marque
S21 open field medium GlobalGAP, BRC, IFS, QS
S22 open field big GlobalGAP, IFS
S23 open field medium GlobalGAP, BRC, IFS, QS, Tesco Nurture, Leaf Marque, McDonalds’ GAP,
Marks & Spencer’s Field-to-Fork
Norway
N07 humid greenhouse with soil small integrated supply KSL, Nyt Norge
N08 continental greenhouse without soil micro chain for local KSL, Nyt Norge, Debio
N09 climate open field small market KSL, Nyt Norge
N10 open field small KSL
N11 open field small KSL, GlobalGAP
N12 open field small KSL, Nyt Norge, Debio
Belgium
B01 maritime open field micro fragmented supply SCS, GlobalGAP
B02 temperate greenhouse with soil micro chain via auction SCS, GlobalGAP
B03 climate greenhouse with soil micro for local and export SCS, GlobalGAP, ICQC
B04 greenhouse with soil micro market SCS, GlobalGAP, ICQC
B05 open field micro SCS, GlobalGAP, ICQC
B06 open field micro SCS, GlobalGAP, ICQC

1
Climate zones are indicated according to the Köppen-Geiger climate classification (Peel, Finlayson, and McMahon, 2007)
2
The classification is according to European Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (EC,
2003): few than 10 people (including seasonal workers) – micro; 10-50 people – small; 50-250 – medium sized; above 250 – big.
3
Characterization of the supply chain
Table(s)
Click here to download Table(s): Draft_article_context_20112013_Table 2.docx
Table 2: Characteristics of the food safety governance for the case studies in Spain, Norway and Belgium
Enforcement
Spanish case: market self-regulation
practice/strategy
Standards GlobalGAP and other private quality assurance
standards for specific retailers (Lario et al, 2006).
No sector guidelines or national guidelines are
applied by these companies apart from legislative
documents (S03-S09a).
Audits Audits against the private standards by third-party
accredited auditing bodies (Lario et al, 2006; S03-
S09).
Sampling plans Regular sampling for pesticide residues and
micro-organisms is performed by the producing
companies, as demanded by the customer
companies (mainly retailers) (S03-S09).
Norwegian case: direct command and control
State-owned voluntary standard for primary
production (KSL) is in place. The
KSL Matmerk is the basis and pre-requisite for the
Nyt Norge standard (Matmerk, 2013; Richards et
al., 2013). The standard is managed by an
independent, publicly supported organisation
(Matmerk), founded by the Ministry of
Agriculture, and managed by a board of
representatives from the agricultural food
producers, retailers and consumers (Matmerk,
2013; Richards et al., 2013).
Risk-based inspections performed by the regional
offices of the food safety authority, and reduced
number of the on-site audits in fresh produce
cultivation (low risk). Every year each company
performs a self-audit against KSL. On-site visits
are also foreseen, based on the risk-based
principles (approx. every 3 years) (Matmerk,
2013). The results from the self-audit are
communicated via a web-based system to
Matmerk. The information from the web-based
system is available to auditors of the KSL
standards, and to the national food safety authority
(Halkier and Holm, 2006; Riksrevisjonen, 2012).
Regular sampling of pesticide residues from the
wholesalers or processing companies, but mainly
focused on imported produce (N12) and not
communicated to the farmers. Lack of structured
sampling on a sector or company level for micro-
Belgian case: co-regulation
Nationally agreed voluntary self-checking
guideline per sector, approved by the competent
authority (Federal Agency for the Safety of the
Food Chain (FASFC)), and an industrial chain-
wide industrial standard (ICQC) are in place. The
private standard GlobalGAP is also widely
implemented.
A sector association (Vegaplan) is managing both
the public self-checking system and the industrial
standard ICQC (e.g. updating, organising
trainings). In Vegaplan are represented the
cultivators’ associations, auctions, produce trading
and processing industry (FASFC, 2003;
Vanhaverbeke, Larosse, & Winnen, 2008;
Mondelaers & Van Huylenbroeck, 2008;
Vegaplan, 2013; B19-B21).
1) The voluntary self-checking system in place:
audits conducted by either the FASFC or by a
commercial accredited certification body,
approved by the agency. Certificate is given, and
valid for 3 years. The audit may be combined with
an audit of voluntary quality assurance standards
(e.g. Global GAP, ICQC).
2) No self-checking system: unannounced random
inspections on hygiene and traceability from the
FASFC (FASFC, 2003; Jacxsens et al., 2013;
B19-B21).
Sampling can be done as sectorial residue
monitoring plan (coordinated by Vegaplan) or as
an own plan of the auction or another trader in
fresh produce. In case of the sectorial residue
monitoring plan every three months anonymously

Sanctions Exclusion of market (S03-S09).
Stimulus Access to market (S03-S09).
Information and Regular training of the cultivators by the central
education quality departments of the traders or processing
companies about application of standards and food
safety management activities (S03-S09).
organisms at cultivation (N11-N18). Sampling
only of the water source.
Industrial self-regulation upon discrepancies in the
KSL by financial sanctions in the form of price
reductions. Listing and thus ‘naming and shaming’
of the companies who exceed the MRLs on the
web site of the national food safety authority
(Matmerk, 2013; N10)
N/Ab (N10)
Training of the cultivators by the produce
organisation upon e.g. changes of requirements
(N11-N18).
all data from the residue analysis is sent to the
sector association Vegaplan.
No organised microbial sampling is done so far.
Some auctions recently started performing
analysis of Salmonella, Listeria, E. coli EHEC and
E. coli as hygiene indicator (FASCF, 2003;
Vegaplan, 2013; B19-B27).
In case of an exceedance of the MRL, a risk
analysis has to be performed by the auction, trader
or the individual cultivator, to check if there is a
risk for public health. When there is risk for the
public health a notification has to be done to the
FASFC will take appropriate measures (e.g. recall,
checking traceability or SCS of the cultivator).
The auction or trader that is responsible for the
sampling is obliged to immediately inform
Vegaplan, and to implement corrective actions at
cultivation. In case of use of unauthorized
pesticide, a notification to FASFC is always
obligatory (Vegaplan, 2013; B19-B27).
Positive incentive by certification (approval) of
the self-checking system leading to reduction of
the annual financial contribution legally due by a
food business operator to the FASFC (i.e.
certification leads to a discount), and reduction of
the inspection frequency (FASCF, 2003; Jacxsens
et al., 2013).
Vegaplan and cultivators’ associations provide
training to the cultivators about the application of
the self-checking system and ICQC (B19). Wide
use of private consultants and advisors, especially
for pest management and pesticides application
(Vegaplan, 2013; B19-B27).

a
Codes of the experts are listed in materials and methods of this article
b
N/A - not applied
Table(s)
Click here to download Table(s): Draft_article_context_20112013_Table 3.docx

Table 3: Number of companies with same scores and mode for indicators of context factors of the companies in
the Spanish, Norwegian and Belgian case.
Frequency Spanish Norwegian Belgian
Indicators
1a 2 3 case case case
PRODUCT CHARACTERISTICS
CP1: Microbiological risk of initial materials 5 2 16 3 3 3
CP2: Risk of initial materials due to pesticides 2 20 1 2 2 2
CP3: Risk of initial materials due to mycotoxins 23 2 2 2
CP4: Microbiological risk of final product 23 3 3 3
CP5: Risk of final product due to pesticides 1 7 15 3 3 3
PRODUCTION CHARACTERISTICS
CP6: Susceptibility of production system 1 4 18 3 3 3
CP7: Risk of climate conditions of production environment 21 2 2 2 2
CP8: Susceptibility of water supply 5 14 4 2 1 2
ORGANISATIONAL CHARACTERISTICS
CO9: Presence of technical staff 5 10 8 1 2 3
CO10: Variability of workforce composition 10 9 4 1 1 2
CO11: Sufficiency of operators’ competences 2 10 11 2 1 3
CO12: Extent of management commitment 6 16 1 1 3 2
CO13: Degree of employee involvement 2 10 11 2 2 3
CO14: Level of formalization 7 14 2 1 2 2
CO15: Sufficiency of supporting information system 5 16 2 2 2 2
CHAIN CHARACTERISTICS
CO16: Severity of stakeholder requirements 2 16 5 2 2 3
CO17: Extent of power in supplier relationships 6 14 3 2 2 2
CO18: Degree of information exchange in supply chain 6 14 3 2 2 2
CO19: Sophistication of logistic facilities 13 9 1 1 2 1
CO20: Supportiveness of food safety authority 5 9 9 3 3 2
CO21: Degree of globalization of supply 14 8 1 1 2 1
CO22: Specificity of external support 19 2 2 1 1 1
CO23: Specificity of food safety legal framework 23 1 1 1

a
Low (1), medium (2) and high (3) risk situations for product and process characteristics correspond to low, potential and high chance
of microbiological or chemical contamination. For organizational and chain characteristics they correspond to supportive, constrained
and lacking administrative chain conditions or low, restricted and high dependence on other chain actors.
Table(s)
Click here to download Table(s): Draft_article_context_20112013_Table 4.docx

Table 4: Total number of companies with same scores, and the modes for the indicators of food safety management practices
of the companies in the Spanish, Norwegian and Belgian case.
Frequency Spanish Norwegian Belgian
Indicators
1a 2 3 4 case case case
PREVENTIVE MEASURES DESIGN
PM24: Sophistication of hygienic design of equipment & facilities 1 7 12 3 2 3 3
PM25: Specificity of maintenance program 1 17 5 3 3 3
PM26: Adequacy of storage facilities 3 14 6 3 3 3
PM27: Specificity of sanitation program 7 11 5 3 3 2
PM28: Extent of personal hygiene requirements 7 12 4 3 3 2
PM29: Sophistication of incoming materials control 1 13 5 4 3 2 2
PM30: Adequacy of packaging 11 1 7 4 4 3 1
PM31: Sophistication of supplier control 2 5 14 2 3 2 3
PM32: Specificity of fertilizer program 7 1 9 6 4 1 3
PM33: Specificity of pesticide program 3 9 11 4 3 3
PM34: Sophistication of water control 1 16 6 4 3 3
PM35: Adequacy of irrigation method 10 12 1 3 2 2
INTERVENTION METHOD DESIGN
IM36: Adequacy of partial physical intervention 8 2 11 2 1 3 1
MONITORING SYSTEM DESIGN
MS37: Appropriateness of hazard analysis 6 5 9 3 3 2 1
MS38: Adequacy of analytical methods for microbiological hazards 12 1 1 9 4 1 1
MS39: Adequacy of analytical methods for pesticide residues 6 1 16 4 1 4
MS40: Specificity of microbiological sampling plan 12 3 2 6 4 1 1
MS41: Specificity of pesticides' sampling plan 6 4 7 6 4 1 4
MS42: Adequacy of measuring equipment 2 2 15 4 3 3 3
MS43: Extent of corrective actions 3 17 3 3 2 2
ACTUAL OPERATION OF CONTROL ACTIVITIES
OC44: Availability of procedures 1 5 10 7 3 4 2
OC45: Compliance to procedures 6 13 4 3 3 2
OC46: Actual hygienic performance of equipment & facilities 6 2 6 9 4 3 1
OC47: Actual cooling and storage capacity 6 3 7 7 4 3 1
OC48: Actual capability of partial intervention 11 2 6 4 1 4 1
OC49: Actual capability of packaging 10 2 6 5 4 3 1
OC50: Actual measuring equipment performance 2 2 15 4 3 3 1
OC51: Actual analytical equipment performance 9 1 1 12 4 1 1
ASSURANCE ACTIVITIES
SR52: Sophistication translating external requirements 3 12 8 4 3 3
 Frequency Spanish Norwegian Belgian
Indicators
1a 2 3 4 case case case
SR53: Extent of systematic use of feedback information 6 13 4 3 3 3
VA54: Sophistication validating preventive measures 6 8 9 3 2 1
VA55: Sophistication validating intervention strategies 8 7 7 1 3 2 1
VE56: Extent verifying people related performance 12 6 5 4 2 2
VE57: Extent verifying equipment & methods performance 10 9 4 3 2 2
DA58: Appropriateness documentation 6 10 7 4 3 2
DA59: Appropriateness record-keeping system 2 17 4 3 3 3

a
Situations 1, 2, 3, and 4 correspond to:
– low situation (1) → absent, not applicable, unknown;
– basic situation (2) → lack of scientific evidence, use of company experience/history, variable, unknown, unpredictable, based on common
materials/equipment;
– average situation (3) → best practice knowledge/equipment, sometimes variable, not always predictable, based on generic
information/guidelines for the product sector;
– advanced situation (4) → scientifically underpinned (accurate, complete), stable, predictable, and tailored for the specific food production
situation.
Table(s)
Click here to download Table(s): Draft_article_context_20112013_Table 5.docx

Table 5: Total number of companies with same scores, and the modes for the indicators of the FSMS output of the
companies in the Spanish, Norwegian and Belgian case.
Frequency Spanish Norwegian Belgian
Indicators
1a 2 3 4 case case case
SA60: Comprehensiveness external evaluation 4 12 7 3 2 3
SA61: Seriousness of remarks 1 2 20 4 4 4
SA62: Type of microbiological complaints 1 2 5 15 4 4 4
SA63: Type of chemical food safety complaints 1 1 12 9 3 4 3
SA64: Type of visual quality complaints 1 4 17 1 3 3 3
SA65: Advancedness of microbiological sampling 10 2 2 9 4 1 1
SA66: Comprehensiveness of judgement criteria for microbial FS 10 1 7 5 3 1 1
SA67: Advancedness of pesticides sampling 6 2 8 7 4 1 3
SA68: Comprehensiveness of judgement criteria for chemical FS 6 2 3 12 4 1 4
SA69: Type of non-conformities 1 3 11 8 3 3 4

a
Situations 1, 2, 3, and 4 correspond to:
– no information (1) → absent, not applied, unknown;
– poor output (2) → ad-hoc sampling, minimal criteria used for evaluation, various food safety problems due to different problems in the
activities;
– moderate output (3) → regular sampling, several criteria used for evaluation, restricted food safety problems mainly due to one (restricted)
type of problem in the activities;
– good output (4) → systematic evaluation, using specific criteria, no safety problems.
*Title Page with names and Institutions only (not sent to Reviewer)
Click here to download Title Page with names and Institutions only (not sent to Reviewer): Title_Manuscript_cultivation_2606

1 Exploring the influence of context on food safety management: Case studies of leafy greens

2 production in Europe

3 Klementina Kirezieva a*, Liesbeth Jacxsens b, Geoffrey J.L.F. Hagelaar c, Martinus A.J.S. van

4 Boekel a, Mieke Uyttendaele b, Pieternel A. Luning a*

a
6 Food Quality and Design Group, Department of Agrotechnology and Food Sciences, Wageningen University,

7 P.O. Box 17, 6700AA Wageningen, The Netherlands

b
8 Department of Food Safety and Food Quality, Laboratory of Food Preservation and Food Microbiology,

9 Faculty of Bioscience Engineering, University of Ghent, Coupure Links, 653, 9000 Ghent, Belgium
c
10 Management Studies Group, Wageningen University, Hollandseweg 1, 6706 KN Wageningen, Netherlands

11

12 *Corresponding author. Mailing address: Food Quality and Design Group, Department of Agrotechnology

13 and Food Sciences, Wageningen University, P.O. Box 17, 6700AA Wageningen, The Netherlands,

14 Phone:+317482087. Fax: +317483669 Electronic mail address: Pieternel.Luning@wur.nl

15 E-mail address:Klementina.Kirezieva@gmail.com

16

17 Keywords: fresh produce; leafy greens; food safety management; food safety governance; co-
18 regulation; systems thinking; context