27 July 2021
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Looking beyond the borders:Integrating best practices in benefit-risk analysis into the field of food and nutrition,
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Please provide the volume number and page range for the bibliography in references ‘Kalogeras et al.
(2011), Luteijn et al. (2011), Magnu´sson et al. (2011), Pohjola et al. (2011a), Tijhuis et al. (2011), Ueland
et al. (2011) and Verhagen et al. (2011)’.
"Developments in other fields are useful to advance benefit–risk analysis in Food and Nutrition. " Decisions to focus on food risks without addressing benefits are often suboptimal. " Benefit–risk analysis should be a joint process to create shared understanding. " Assessors, managers and stakeholders each have an essential role in this process. " Contributions from all relevant actors are required to improve benefit–risk analysis.
1
2
Looking beyond
borders:
Integrating
best practices
in
benefit–risk analysis
3
into the
field
of Food and Nutrition
4
M.J.
Tijhuis
a,b,⇑,
M.V.
Pohjola
c,
H.
Gunnlaugsdóttir
d,
N.
Kalogeras
b,
O.
Leino
c,
J.M.
Luteijn
e,
5S.H.
Magnússon
d,
G.
Odekerken-Schröder
b,
M.
Poto
f,g,
J.T.
Tuomisto
c,
Ø.
Ueland
h,
B.C.
White
i,
6F.
Holm
j,
H.
Verhagen
a,k,l7 a
National Institute for Public Health and the Environment (RIVM),P.O.Box 1, 3720 BA Bilthoven,TheNetherlands
8 b
Maastricht University, School of Business and Economics,P.O.Box 616, 6200 MD Maastricht, The Netherlands
9 c
National Institute for Health and Welfare (THL),P.O.Box 95,FI-70701Kuopio, Finland
10 d
Matís, Icelandic Food and Biotech R&D, Vínlandsleið 12, 113 Reykjavík,Iceland
11 eUniversity of Ulster, School of Nursing, Shore Road, Newtownabbey (Jordanstown), BT370QBNorthern Ireland, United Kingdom
12 f
University of Turin, Facoltà di Giurisprudenza, Dipartimento di Scienze Giuridiche, vi Sant’Ottavio 54, 10124 Torino, Italy
13 g
Precon Food Management BV, Regulierenring 16 Bunnik, The Netherlands
14 h
Nofima, Oslovn 1, N-1430 Ås, Norway
15 i
University of Ulster, Department of Pharmacy & Pharmaceutical Scienes, School of Biomedical Sciences, Cromore Road, Coleraine, BT521SANorthern Ireland, United Kingdom
16 j
FoodGroup Denmark & Nordic NutriScience, Rugaardsvej 14, A2, Rugaard, DK-8400 Ebeltoft,Denmark
17 kMaastricht University, NUTRIM School for Nutrition, Toxicology and Metabolism,P.O.Box 616, 6200 MD Maastricht, TheNetherlands
18 lUniversity of Ulster, Northern Ireland Centre for Food and Health (NICHE), Cromore Road, Coleraine, BT521SANorthern Ireland, United Kingdom
19 20 2 2
a r t i c l e
i n f o
23 Article history: 24 Available online xxxx 25 Keywords: 26 Benefit–risk 27 Food 28 Nutrition 29 Medicines 30 Microbiology 31 Environment 32 3 3a b s t r a c t
34An integratedbenefit–riskanalysis aims to give guidance in decision situations where benefits do not
35
clearly prevail over risks, and explicit weighing of benefits and risks is thus indicated. The BEPRARIBEAN
36
project aims to advancebenefit–riskanalysis in the area of food and nutrition by learning from other
37
fields. This paper constitutes the final stage of the project, in which commonalities and differences in
ben-38
efit–riskanalysis are identified between the Food and Nutrition field and other fields, namely Medicines,
39
Food Microbiology, Environmental Health, Economics andMarketing–Finance,and Consumer Perception.
40
From this, ways forward are characterized forbenefit–riskanalysis in Food and Nutrition. Integrated
ben-41
efit–riskanalysis in Food and Nutrition may advance in the following ways: Increased engagement and
42
communication between assessors, managers, and stakeholders;morepragmatic problem-oriented
fram-43
ing of assessment;acceptingsome risk;pre-and post-market analysis;explicitcommunication of the
44
assessment purpose, input and output; morehuman (dose–response)data and more efficient use of
45
human data;segmentingpopulations based on physiology; explicitconsideration of value judgments
46
in assessment; integrationof multiple benefits and risks from multiple domains;explicitrecognition
47
of the impact of consumer beliefs, opinions, views, perceptions, and attitudes on behaviour; and
segment-48
ingpopulations based on behaviour;theopportunities proposed here do not provide ultimate solutions;
49
rather, they define a collection of issues to be taken account of in developing methods, tools, practices and
50
policies, as well as refining the regulatory context, forbenefit–riskanalysis in Food and Nutrition and
51
other fields. Thus, these opportunities will now need to be explored further and incorporated into
ben-52
efit–riskpractice and policy. If accepted, incorporation of these opportunities will also involve a paradigm
53
shift in Food and Nutritionbenefit–riskanalysis towards conceiving the analysis as a process of creating
54
shared knowledge among all stakeholders.
55
Ó 2011 Elsevier Ltd. All rights reserved.
56 57 58 59 1. Introduction and approach
60
Benefit–riskanalysis of Food and Nutrition is developing fast. 61
Benefit–riskanalysis aims to give guidance in decision situations 62 where both benefits and risks have been identified; when the
63 benefits do not clearly prevail over the risks, explicit weighing of
64 benefits and risks is indicated. Benefit–riskanalysis can be seen
65 as a triad of the (1) assessment, (2) management and (3) 0278-6915/$ - see front matter Ó 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.fct.2011.11.044
Abbreviations: CVD, cardiovascular disease; DALY, disability adjusted life year; EFSA, European Food Safety Authority; HTA, health technology assessment; QALY, quality adjusted life year.
⇑ Corresponding author at: National Institute for Public Health and the Environ-ment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Tel.: +31 30 2742637; fax: +31 30 2744466.
E-mail address:mariken.tijhuis@rivm.nl(M.J. Tijhuis).
Q1
Q2
Contents lists available atSciVerse ScienceDirect
Food and Chemical Toxicology
j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / f o o d c h e m t o x
66 communication of integrated benefits and risks, analogous to the 67 common contemporary risk analysis paradigm (Fig. 1) (WHO/ 68 FAO, 1995).
69 Benefit–riskassessment of Food and Nutrition comprises a sci-70 ence-based process intended to qualitatively or quantitatively esti-71 mate the benefits and risks for humans following exposure (or lack 72 of exposure) to a particular food or food component and includes 73 the potential to integrate them into comparable measures.
Bene-74 fit–riskmanagement entails the process of weighing policy alterna-75 tives in light of the results ofbenefit–riskassessment and other 76 relevant information.Benefit–riskcommunication covers the inter-77 active exchange of information and science-based opinions con-78 cerning benefits and risks among assessors, managers, consumers 79 and other stakeholders.
80 The scope of Food and Nutrition risk assessment is fairly well 81 established (Renwick et al., 2003); it deals with the assessment 82 of adverse health effects caused by physical or chemical agents, 83 occurring naturally in foods or as environmental contaminants, 84 or resulting from food preparation or manufacturing processes. 85 However, in thebenefit–riskcontext, the scope of benefit-assess-86 ment is a point of discussion. A beneficial effect can be looked at 87 as the reverse of an adverse effect (WHO, 1994), i.e. a physical or 88 other change within a person that improves functional capacity 89 or the capacity to deal with stress or that decreases susceptibility 90 to harmful effects. This can be measured as prevention of disease, 91 i.e. reduction of risk, but currently it is difficult to measure benefits 92 directly, at an early stage or as an ‘above-normal’ capacity. Cases 93 where the benefit is obvious but where different risks are involved 94 (in severity and mechanism) could also be taken under the wing of 95 benefit–risk analysis. Benefit–risk analysis presents up-to-date 96 knowledge in a dynamic public health process, aimed at optimiza-97 tion, i.e. looking for ways to maximize benefits while minimizing 98 risk.
99 In recent years, many projects have done significant work to 100 identify the possibilities and difficulties of benefit–riskanalysis 101 in the Food and Nutrition field (Tijhuis et al., 2011). Much progress 102 has already been made, butbenefit–riskthinking and practise have 103 not yet become commonly established. Therefore, for further 104 development, the field of Food and Nutrition could benefit from 105 looking beyond its borders and learning from other fields of re-106 search (and possibly also vice versa) and this is the explicit goal 107 of BEPRARIBEAN project (http://en.opasnet.org/w/Bepraribean) 108 (Verhagen et al., 2011). To serve this goal, we recently compiled re-109 views covering the state of the art inbenefit–riskanalysis for Food 110 and Nutrition (Tijhuis et al., 2011) and five other fields: Medicines 111 (Luteijn et al., 2011), Food Microbiology (Magnússon et al., 2011), 112 Environmental Health (Pohjola et al.,2011a),Economics and
Mar-113 keting–Finance(Kalogeras et al., 2011) and Consumer Perception 114 (Ueland et al., 2011). The individual reviews were led by the
115 researchers from within the respective fields and were contributed
116 to by the researchers from the other fields. Summaries of the key
117 issues from the reviews and a summary of the contemporary
reg-118 ulatory context for Food and Nutrition management and
assess-119 ment are presented inSection2.
120 InSection3, the focus is on identifying how thebenefit–risk
ap-121 proaches in the different areas compare to and differ from the
ben-122
efit–riskapproaches in the area of food and nutrition. In order to 123 exemplify the (combined) perspectives and approaches from
with-124 in the different areas, we include an example of a case: the effects
125 of replacing current animal protein sources by more sustainable
126 dietary protein sources. This topic was considered suitable because
127 it is inherently multi-disciplinary and currently of global interest.
128 This example is meant as an illustration and does not aim to be a
129 conclusive analysis.
130 From this, inSection4, we aim to identify opportunities for
fur-131 ther development ofbenefit–riskanalysis in food and nutrition.
132 InSection5, we sum up the main points of this paper, and the
133 whole BEPRARIBEAN project, and indicate some implications that
134 these points will or may have for Food and Nutritionbenefit–risk
135 analysis in the future.
136 2. Summaries of key issues by focus area and EU regulatory
137 context for Food and Nutrition
138 In2.1–2.6we summarize the key issues from the 6 state of the
139 art reviews: Food and Nutrition (Tijhuis et al., 2011), Medicines
140 (Luteijn et al., 2011), Food Microbiology (Magnússon et al., 2011),
141 Environmental Health (Pohjola et al., 2011a), Economics and
142
Marketing–Finance(Kalogeras et al., 2011) and Consumer Percep-143 tion (Ueland et al., 2011). They are complemented in 2.7 with a
144 short overview of the contemporary regulatory context for Food
145 and Nutrition management and assessment in the European Union.
146 2.1.Benefit–riskanalysis in Food and Nutrition (Tijhuis et al., 2011)
147 This paper addresses the three components ofbenefit–risk
anal-148 ysis, but focuses on assessment.Benefit–risk assessment in Food
149 and Nutrition is geared to weigh the beneficial and adverse effects
150 a food or food component may have, in an integrated measure, in
151 order to make better-informed policy decisions regarding public
152 health issues.
153 Historically, the assessments of risks and benefits have been
154 separate processes. In risk assessment, toxicology is the main
con-155 tributor as the toxicological approach is demanded by regulation. It
156 traditionally assumes that a maximum safe dose can be
deter-157 mined from studies in experimental animals or sometimes humans
158 and that division of this dose by appropriate safety factors defines
159 the ‘safe’ intake for the human population. Epidemiology plays a
160 minor role in risk assessment. Epidemiology describes associations
161 between risk (or beneficial) factors and disease endpoints in
hu-162 mans. It has traditionally focussed more on relative than on
abso-163 lute risks. Nutrition, as a science, uses a mixture of methodologies
164 and is involved in estimating risks specifically for nutrients and
165 other dietary factors. Benefit assessment for Food and Nutrition
166 is newly developing in regulatory terms, but has been the subject
167 of nutritional epidemiological research for a long time. Benefit
168 assessment is working on concepts such as whether reduction of
169 risk of disease should be termed a benefit, whether a benefit can
170 be measured as a state rising above the average health and in
171 which time frame (short or long term), and how broad its scope
172 should be. In nutrition, current interest is in ‘optimal’ food and
173 nutrient intake, implying knowledge of both intakes where risks
174 occur and intakes where benefits occur. In this, there is a scientific
175 development away from general population intakes towards an
Assessment Management
Communication
Benefit-Risk Analysis Framework
(science) (policy)
(interactive exchange of information and opinions among all stakeholders)
Fig. 1. Contemporary benefit–risk analysis framework. Based on the risk analysis framework byWHO/FAO (1995).
176 intake based on subgroups. In summary, the goal of risk assess-177 ment in food and nutrition is to reasonably guarantee absence of 178 an effect (risk) whereas the goal of benefit assessment is to reason-179 ably guarantee the presence of an effect (benefit). This distinction 180 affects the assessment approach, the evaluation of the generated 181 data and the way these can be used. In both risk and benefit assess-182 ment, gooddose–responsedata, i.e. with relevant intake levels and 183 suitable for the target population, are scarce. Better integration of 184 all underlying disciplines and an approach focussed more on hu-185 mans and continuous data is indicated.
186 Current approaches to bring benefit and risk assessment to-187 gether mirror the traditional risk assessment paradigm of hazard 188 identification, hazard characterization, exposure assessment and 189 risk characterization. A tiered approach is advocated, as this allows 190 for transparency, in-between consultancy with the benefit–risk
191 manager and the possibility of an early stop in the assessment 192 and thus increased efficiency. There is agreement about the impor-193 tance of a good description of thebenefit–riskquestion and the 194 uncertainties in its assessment. Benefit–risk comparison can be 195 qualitative and quantitative, with increasing data requirements. 196 In a quantitative comparison, benefits and risks are expressed in 197 a common currency. Severity of disease can be taken into account 198 by attributing weights, e.g. using disability adjusted life years 199 (DALY’s). These integrated measures need to be accompanied by 200 at least (1) a description of the unintegrated benefits and risks 201 on subgroups and (2) data uncertainties. In the quantification 202 process, deterministic input may be substituted by probabilistic 203 input; well-accepted methodology for probabilistic assessment is 204 available.
205 Close communication, between and withinbenefit–risk asses-206 sors and managers, requires attention. Inbenefit–riskmanagement 207 some risk will have to be considered acceptable in order to achieve 208 more benefits. Thus, current risk management will also need to 209 consider a shift from striving for zero risk towards explicit weigh-210 ing of risks and benefits in order to achieve an optimal outcome. 211 The communication of benefits and risks to the public used to be 212 separate, but the impact of combined benefit–risk messages is 213 being explored.
214 In conclusion,benefit–riskassessment is developing steadily in 215 the field of food and nutrition. General point of attention is the 216 communication between fellow scientists, managers and the gen-217 eral public. General strengths are the ability to systematically 218 and transparently show the current knowledge and its gaps and 219 to provide what is likely the best answer to a question with a large 220 potential impact on public health.
221 2.2.Benefit–riskanalysis in Medicines (Luteijn et al., 2011)
222 Medicines can lead to significant health benefits. The health 223 benefits come at the risk of potential adverse drug reactions. Since 224 the thalidomide disaster in the early 1960s, increased regulatory 225 attention has been placed in thebenefit–riskprofiles of medicines. 226 This key-event has lead to not only demands on safety demonstra-227 tion before registration of a medicine, but also to demands in re-228 gard to demonstration of efficacy, i.e. the effectiveness of a 229 medicine under controlled conditions.
230 Benefit–riskassessment in medicine is highly regulated and has 231 been developed for decennia.Benefit–riskassessment (and moni-232 toring) takes place both in the pre-registration and the post-regis-233 tration phase of a medicine. In the pre-registration phase, the 234 candidate medicine goes through a process of phaseI–III trials, 235 involving populations of increasing size and different aims and de-236 signs as discussed in the state of the art paper. These clinical trials 237 are conducted by the manufacturer and involve a considerable 238 financial investment. Trials will only be continued if the manufac-239 turer feels the drug stands a chance to successfully gain marketing
240 authorization by sufficient proof of efficacy and safety. Data
gath-241 ered by these clinical trials, reinforced by animal model data and
242 possible post-marketing experience with similar compounds, will
243 provide the safety and efficacy data for the marketing
authoriza-244 tion procedure. The pre-marketing clinical trials have been
245 criticized for being designed for fast approval instead of the
gener-246 ation of scientific knowledge. A number of mainly quantitative
247
benefit–risk methods are employed during the pre marketing 248 phase, including ‘number needed to treat’ and ‘number needed to
249 harm’. Expert opinions play a big role inbenefit–riskassessment
250 of medicines, both pre-registration and post-registration. There is
251 no standard protocol for analyzing the benefit–riskprofile of a
252 drug, after the manufacturer submits the clinical trial data,
respon-253 sible authorities will take the evidence into account and form an
254 expert opinion on the registration submission. Both the benefits
255 (efficacy) and the risk (adverse drug reactions, ADRs) play a role
256 in this expert opinion: larger benefits can justify larger risks. No
257 consensus has been reached on a standardized methodology for
258
benefit–risk assessment in medicine registration. The European 259 Committee for Medicinal Products for Human Use recommends
260 the use of multiple types of mainly qualitative,benefit–risk
meth-261 odology and argues that use of quantitative methodology can lead
262 to a misleading feeling of precision.
263 2.2.1. Pre-registration
264 The pre-registration clinical trials themselves suffer from a
265 number of practical limitations; these include the small number
266 of subjects in clinical trials, a restricted population in terms of
267 age, gender and ethnicity, restricted co-medication and
co-morbid-268 ity, a short duration of exposure and follow up and statistical
prob-269 lems with assessing multiple outcomes. These problems are
270 acknowledged by the responsible authorities. Because the clinical
271 trials take place in a controlled environment, situations of off-label
272 use,drug–druginteractions and non-compliance will be limited to
273 theoretical consideration. Therefore, clinical trials will provide
274 information on the efficacy of a medicine, rather than effectiveness
275 of a medicine. Despite the differences between efficacy and
effec-276 tiveness, efficacy will provide an indication of effectiveness of a
277 drug. It should be realized there is no solution for the majority of
278 these problems. For example; it would be ethically unacceptable
279 to conduct safety experiments in pregnant women. Experience in
280 this population will be limited to animal models and
post-registra-281 tion data.
282 During the application process, a risk management program
283 will be submitted along with the clinical trial data, outlining risk
284 minimization and post marketing surveillance activities.
285 2.2.2. Post-registration
286 After registration, thebenefit–riskprofile of medicines will be
287 monitored by post-marketing surveillance. Pre-marketing
knowl-288 edge on thebenefit–riskprofile of a medicine will be limited for
289 reasons mentioned above. Post-marketing surveillance is
con-290 ducted by responsible authorities, marketing authorization holders
291 and independent researchers in order to collect data on ADRs and
292 monitor the effectiveness of existing risk management activities. In
293 case a new ADR is discovered, responsible authorities can reassess
294 the benefit risk profile forming a new expert opinion. Information
295 discovered during post-marketing surveillance can lead to
modifi-296 cation of marketing authorizations, risk management programs or
297 even suspension of marketing authorizations in the case of serious
298 ADRs. Many recent developments and initiatives are currently
299 ongoing in post-marketing surveillance, many of them involving
300 large databases to collect information on ADRs. The more statistical
301 power, the better the investigators are able to detect ADRs. For this
302 reason, an increasing amount of international cooperation is taking
303 place in Europe. Other problems include different legislation be-304 tween European countries.
305 A different type ofbenefit–riskassessment in the post-registra-306 tion phase is Health Technology Assessment (HTA). In HTA, the 307 health impact and economic impact of a new health technology 308 are assessed using (economic) modelling techniques, usually in or-309 der to be included in public formularies. The main challenge of HTA 310 is to assess the trade-offs between financial investment and health 311 benefits. For this purpose, indexes such as QALY and DALY have 312 been developed. The trade-off between financial investment and 313 health benefits is perceived as controversial by many. Marketing 314 authorizations have become less meaningful without reimburse-315 ment (after a positive HTA assessment) in many countries. The 316 mandate and methodology of HTA agencies differ between 317 countries.
318 The state of the art paper concluded that no ‘one size fits all’ ap-319 proach is available for benefit–risk assessment in medicines. 320 Choice of methodology depends on the context of thebenefit–risk
321 assessment, including indication, patient groups and the stage of 322 the regulatory process. Also, use of multiple methodologies is 323 encouraged due to each having its own specific strengths and 324 weakness. Furthermore, improved cooperation between responsi-325 ble authorities and HTA agencies can be of value inbenefit–risk
326 assessment.
327 2.3.Benefit–riskanalysis in Food Microbiology (Magnússon et al., 328 2011)
329 Microorganisms, i.e. bacteria, fungi and viruses, are all constitu-330 ents of our natural environment. The field of food microbiology 331 concerns the multitude of microorganisms that inhabit and con-332 taminate our foods. Food and nutrition are essential for sustaining 333 human life. However, no food carries zero risk for microbiological 334 hazards. The risk varies considerably depending on food types 335 and matrices. Some foods have a higher risk than others of contain-336 ing microbiological contaminants and pathogenic microorganisms 337 that can be hazardous to our health and well being. Furthermore, 338 consumer sub-groups can be variably susceptible to foodborne 339 infections and intoxications; the elderly, young children and indi-340 viduals with underlying diseases being more at risk.
341 Food microbiology is largely focused on food safety and limiting 342 public exposure to harmful foodborne pathogens. However, the 343 great majority of microorganisms are harmless to our health and 344 many microorganisms are even important to various food produc-345 tion processes e.g. the making of cheese, wine, beer and bread. 346 Microorganisms are used in various ways for the benefits of hu-347 mans e.g. through advances in medical technology, biotechnology, 348 agriculture and in food processing, to name a few. Although micro-349 organisms can be seen as indirectly beneficial to human health 350 through the above-mentioned activities, the human health conse-351 quences of microorganisms in foods are often either neutral or ad-352 verse. In food microbiology the reduction in human exposure to 353 foodborne pathogens can commonly be regarded as the main pub-354 lic health benefit. Probiotic microorganisms and the activities of 355 the gut microflora can be mentioned as an exception to this – 356 the effect of probiotics can be seen as directly beneficial to human 357 health. It must be noted, however, that to date all such probiotic 358 health claims have been refuted by the European Food Safety 359 Authority (EFSA, http://www.efsa.europa.eu/en/topics/topic/arti-360 cle13.htm); currently, there is lack of evidence for the direct bene-361 ficial effects as judged by EFSA’s criteria, but at the same time there 362 is lack of evidence that beneficial effects do not exist.
363 Benefit–risk analysis is a relatively new and to-date largely 364 undefined field of research within food microbiology. The
bene-365 fit–riskanalysis approach is concerned with issues affecting public 366 health and improving public health management based on the
367 balanced weighing of risks and benefits. From a food
microbiolog-368 ical standpoint studies using methods that balance risks and/or
369 risks and benefits using composite metrics are scarce. Published
370 studies to date have mainly been intervention assessments or risk
371 comparison studies that apply risk assessment criteria for
compar-372 ing the level of two individual risk factors – with the purpose of
373 identifying the most important health risks – commonly a
chemi-374 cal risk and the benefits of reduced microbiological risk. The
crite-375 ria for the assessment of risks are well established within food
376 microbiology (and are based on risk assessment criteria developed
377 within toxicology), but at present the criteria for assessing positive
378 health effects are not well defined.
379 A key issue in food microbiologicalbenefit–riskanalysis is how to
380 address the assessment of benefits and the multidisciplinary
discus-381 sion of how to aggregate risk and benefit estimates. The most
382 straightforward approach to be used forbenefit–riskanalysis in food
383 microbiology could be envisioned to follow the tiered approach for
384
benefit–riskanalysis formulated in the field of food and nutrition. 385 Food microbiologicalbenefit–riskanalysis converges largely with
386 that of food and nutrition. In addition, it often involves the
evalua-387 tion of chemical as well as microbiological risks and benefits.
388 Disability adjusted life years (DALY’s) have widely been opted
389 for as a metric of choice for ranking microbiological risk, including
390 foodborne pathogens. It can be used as the single metric for
assess-391 ing both microbiological and chemical hazards and could similarly
392 be implemented for evaluating benefits. DALY’s have previously
393 been used for assessing the global burden of disease, injury and
394 risk factors and currently the global burden of foodborne disease
395 is being estimated using DALY’s(http://www.who.int/foodsafety/
396 foodborne_disease/ferg/en/index3.html). Based on this extensive
397 groundwork, as food microbiology benefit–risk analysis goes,
398 DALY’s are likely to be the common metric of choice, despite its
399 shortcomings.
400 In conclusion, the field ofbenefit–riskanalysis in food
microbi-401 ology is in its infancy and the assessment criteria for benefits are
402 not well defined. Reduced pathogen risk can be seen as the
princi-403 pal benefit regarding food microbiology while scientific data on
di-404 rect microbial benefits are lacking.
405 2.4.Benefit–riskanalysis in Environmental Health (Pohjola et al.,
406
2011a)
407 The field of environmental health is very broad and involves
sig-408 nificant physico-chemical, biological, technological and social
409 complexity. Consequently there is no single state-of-the-art
ap-410 proach, but a multitude of approaches to assess environmental
411 health risks and benefits have been developed for different
pur-412 poses and contexts within the field. These approaches can be
char-413 acterized e.g. as either regulatory or academic, depending on the
414 context of development and application for the approach, or rather
415 traditional or novel, depending on how strictly and narrowly the
416 assessment scope and procedure are determined by the approach.
417 In comparison to the traditional and regulatory approaches the
418 emphasis among the more novel and academic approaches is on(a)
419 increased engagement between assessors, decision makers, and
420 stakeholders, (b) more pragmatic problem-oriented framing of
421 assessments,(c) integration of multiple benefits and risks from
422 multiple domains, and(d)inclusion of values, alongside scientific
423 facts, in explicit consideration in assessment. These tendencies
424 can be considered as responses to the challenge of complexity
425 within the field, but also as indications of the incapability of the
426 currently established approaches to adequately address all aspects
427 of this complexity. On the other hand, the all-embracing aims of
428 the novel academic approaches may also lead to lack of clarity in
429 comparison to the regulatory and traditional approaches, unless
430 duly designed and implemented.
431 The key issues inbenefit–riskanalysis in environmental health 432 are not so much related to the technical details of performing the 433 analysis, but rather to(i)the level of integration, and(ii)the per-434 spective to consider the relationship between assessment and the 435 use of its outcomes. The level of integration can range from pro-436 ducing health risk estimates for single substances to aggregation, 437 weighing, and comparison of multiple benefits, risks, impacts, 438 and costs alongside explicit account of values of those concerned. 439 Significant differences are also brought about by whether an 440 ‘‘assessment push’’ or an ‘‘information need pull’’ perspective is 441 adopted. The perspective largely defines what, how and why, is-442 sues are considered in an assessment.
443 In the ‘‘assessment push’’ perspective, the issue to be assessed is 444 defined by those responsible for the assessment, and the focus of 445 assessment is to produce an objective estimate of the risks, 446 benefits,etc. according to certain defined principles and means, 447 whatever the estimate may be used for. Approaches taking an 448 assessment push perspective thus also predetermine the possible 449 levels of integration in terms of e.g. what phenomena are consid-450 ered, whether also benefits or costs are considered in addition to 451 risks, and what means of aggregation or comparison are used. In 452 the ‘‘information need pull’’ perspective the issue to be assessed, 453 as well as the principles and means for its assessment, is formu-454 lated according to a specified practical need. The need thus deter-455 mines the suitable format of the assessment outcome, which 456 further determines how the assessment should be made. Therefore 457 inclusion of all relevant issues, all levels of integration, and all 458 means of aggregation and comparison are, at least in principle, 459 available for use as required to serve the need. Naturally, most of 460 the approaches to environmental health assessment fall some-461 where in between these extremes by incorporating aspects of both 462 push and pull. However it can be identified that the regulatory and 463 the most traditional, simultaneously the currently most estab-464 lished, approaches clearly position themselves closer to the assess-465 ment push end of the continuum.
466 Challenges lie in the aggregation, weighing, and/or comparison 467 of multiple benefits and risks. For example: the use of DALY’s, 468 QALYs or euro’s as general aggregate measures, incommensurabil-469 ity of benefit estimates aiming for avoidance of false positives and 470 risk estimates aiming for avoidance of false negatives, and taking 471 account of perceived risks and benefits together with ‘‘scientifically 472 assessed’’ risk and benefit estimates.
473 In conclusion, probably most of all commonly known methods 474 forbenefit–riskanalysis are applied among the various different 475 approaches to environmental health assessment, but there is no 476 single view to dominate the whole broad field.
477 2.5.Benefit–riskanalysis in Economics andMarketing–Finance
478 (Kalogeras et al., 2011)
479 Risk is a key component of economic behaviour. All market par-480 ticipants (e.g. investors, producers, consumers) accept a certain 481 level of risk as necessary to achieve certain benefits. There are 482 many types of risk including price, production, financial, institu-483 tional, and individual human (e.g. health-related) risks. All these 484 risks should be effectively managed in order to derive the utmost 485 of benefits and avoid disruption and/or catastrophic economic 486 consequences for the food industry and market participants’ 487 wellbeing.
488 In (food) economics, finance and marketing-management liter-489 ature, the utility concept (total satisfaction received from consum-490 ing a product/service) plays a crucial role in determining market 491 participants’benefit–risktrade-offs that drive economic phenom-492 ena. This utility is often derived from outcomes such as wealth, 493 income, profit, selling price, among others. That is, the outcome 494 domain is a monetary one. Yet, in behavioural economics,
495 behavioural finance, economic psychology, marketing and
con-496 sumer behaviour literature, market participants may also derive
497 utility from non-monetary outcomes by exposing a combination
498 of cognitive and affective behaviour.
499 The dominant paradigm in business economics on which
deci-500 sion makers (e.g. farmer, food manufacturer, retailer, consumer)
501 rely in theirbenefit–risktrade-offs is the expected utility model.
502 This model is concerned with choices among risky prospects. The
503 goal of a decision maker is the maximization of his/her expected
504 utility. In the expected utility framework, the shape of the utility
505 function is assumed to reflect a decision maker’s risk preference.
506 Therefore, the expected subjective utility function of any prospect
507 reveals the individuals’ attitudes towards risk. There is a
continu-508 ous stream of research on decision makers’ risk preferences in
509 the fields of food economics andmarketing–financethat employs
510 expected utility models that are objective or normative, i.e.
511 assumption and establishment of norms implying the rationality
512 principle in economic behaviour of market-participants:
maximi-513 zation of their utility, by using time series and/or panel data for
514 production, consumption, pricing levels of food products; and
sub-515 jective, i.e. relaxing the rationality assumptions inherent in the
516 normative models by using survey- and experimental-based data
517 gathering instruments involving psychometric constructs or
lotter-518 ies. Both theoretical and empirical research accounts show that
519 decision makers can be simultaneously seeking and
risk-520 averse in different domains, implying that risk preference is
con-521 text-specific.
522 In the context of agribusiness and food markets, concerns about
523 food safety, quality, and nutrition have persistently been present at
524 all levels of decision making (operational,tactical andstrategic) by
525 food producers, manufacturers, commodity traders, retailers, and
526 consumers. However, business economic scholars are often
con-527 fronted with conceptual and methodological challenges due to
528 the unobserved and multidimensional nature of human decision
529 making process. That is, the actual behaviour of market
partici-530 pants is not always consisted with the ‘‘true’’ level of risk that they
531 face.
532 Recent research in management sciences and decision analysis
533 argued that by decoupling the benefit–risktrade-offs of decision
534 makers into separate dimensions a more robust conceptualization
535 and prediction may be achieved. Specifically, market participants
536 have two kinds of evaluation systems on which perceived and/or
537 actual benefits of an investment or consumption object cognitively
538 rely on:(a)utilitarian dimension of instrumentality and(b)a
hedo-539 nic dimension. The first dimension refers to how useful or
benefi-540 cial the investment or consumption action is. The second
541 dimension of benefits refers to the experiential affect associated
542 with the investment and consumption. These two dimensions are
543 neither mutually exclusive nor need to be evaluative consistent.
544 Similarly, risk behaviour may be decoupled into the separate
545 dimension of risk attitude and risk perception. Risk attitude is
546 formed by one’s predisposition to the content of the risk in a
spe-547 cific market situation and reflects a decision-maker’s
interpreta-548 tion of this risk content in a specific way, whereas risk perception
549 refers to the likelihood of one’s exposure to the risk content. This
550 decoupling approach may serve as the basis for studying the
deci-551 sion-making process of market participants regarding food
safety-552 and nutrition-related issues, in the light ofbenefit–risktrade-offs.
553 Yet, one may recognize the challenges for operationalising such a
554 framework, adapt it to specific decision contexts, and accounting
555 for its dynamics.
556 In conclusion, the study of market participants’ benefit–risk
557 trade-offs in business economics rely on the utility concept.
558 Although the dominant paradigm in economics is the expected
559 utility model that has a normative nature, the behavioural study
560 of market participants’benefit–risktrade-offs emerges. Nowadays,
561 there are various and different approaches and techniques to 562 businesses economics to identify and evaluate the benefit–risk
563 trade-offs on institutional or individual market participants. Yet, 564 there is no single view to dominate the whole discipline. The 565 decoupling of benefit–risk behaviour into separate components 566 that deal with both the utilitarian as well as hedonic aspects of 567 benefits and risks may offer more robust conceptualizations and 568 predictions for studying benefit–risktrade-offs in various highly 569 uncertain decision contexts entailed in the agribusiness and food 570 markets.
571 2.6.Benefit–riskanalysis in Consumer Perception (Ueland et al., 2011)
572 Food and nutrition are central to the survival of human beings 573 as well as to their well-being and quality of life. However, a ‘‘nutri-574 tionally perfect life’’ is not necessarily consistent with consumers’ 575 feelings of how a perfect life should be which again has implica-576 tions for what motivates consumers’ food choice. The inconsisten-577 cies are partly the result of consumers’ perceptions of benefits and 578 risks with regard to food and nutrition and of the way consumers 579 trade off between benefits and risks in order to maximize the out-580 come they prefer. Thus, by incorporating the study of consumers’ 581 perception of benefits and risks in a food and nutrition context, 582 possible outcomes of food and nutrition measures can be better 583 understood.
584 For consumers, benefit perception of food is usually more 585 important than risk perception. The benefits are particularly re-586 lated to the hedonic perspective; food should taste good, be plea-587 surable and fulfil expectations to an enjoyable experience. Risks, 588 on the other hand, are more often subject to conscious delibera-589 tions and external factors, such as available information, media 590 coverage and personal interest that contribute to consumers’ risk 591 perception.
592 Consumers’ perception of risks is associated with mortality 593 and morbidity and goes along two main dimensions related to; 594 the extent that the risk is unknown, and what are the conse-595 quences of the risk. Food risks are not perceived to be as severe 596 as are for instance risks associated with firearms or airplanes. 597 However, some foods, particularly those that score high on the 598 unknown dimension, are perceived with trepidation by consum-599 ers. Conversely, foods that are perceived as risky are often foods 600 that are unfamiliar or produced by novel technologies. Further-601 more, foods that are (perceived to be) highly processed are con-602 sidered to be less desirable and more risky, than foods 603 perceived to have a low level of processing. The possibility to dis-604 cern what the food product is made of, or what it is derived from, 605 contributes to a feeling of safety and to lower risk perception 606 among consumers.
607 There are ways to reduce perceived risk of foods for instance 608 through familiarising the consumer with the food, or by adding 609 characteristics that may be seen as benefits to the food product. 610 Increasing healthiness and enhancing taste are factors that make 611 consumers more willing to accept the product. Adding benefits to 612 a product does not reduce the risk itself but reduces the consum-613 ers’ perception of the risk. Benefit and risk perception of foods 614 are in many cases inversely correlated: when something is per-615 ceived as being highly beneficial, it is correspondingly perceived 616 as having low risk. However, slightly different paths are used in 617 the formation of these perceptions; benefit perception is based 618 on heuristics and experience, while risk perception is largely the 619 result of cognitive information processing.
620 Nutrition is one aspect belonging to food products that is nor-621 mally not associated with hedonic benefits of foods. However, 622 nutrition is accepted as an essential part of consumers’ life, and 623 health attributes of foods are perceived as benefits when diet con-624 siderations are important for the consumers. Consumers easily
625 perceive risks belonging to malnutrition, both related to
over-626 and under-consumption of nutrients, but consumers’ may choose
627 not to pay attention to these risks.
628 In conclusion, in a food and nutrition setting it is important to
629 understand which food attributes related to perceived and real
630 benefits and risks that influence food choice, in order to provide
631 for an optimal diet from both a health perspective as well as from
632 a hedonic perspective.
633 2.7. Contemporary regulatory context for Food and Nutrition
634 assessment and management
635 The EU Food Safety legislation(http://ec.europa.eu/food/food/
636 foodlaw/index_en.htm)(EU, 2000) is built around high food safety
637 standards, of which the final aim is to protect the health of the
con-638 sumers and to reduce the risks connected to unsafe food (van der
639 Meulen and van der Velde, 2008).
640 The development of the requirements is the result of stratified
641 legislative measures, often approved by incidents (food safety
cri-642 ses consequent to foodborne diseases) rather than by a systematic
643 legislative plan. Regulation EC/178/2002 is the General Food Law,
644 containing general provisions useful to orientate the interpreter
645 in understanding the mechanisms and procedures to be followed
646 in order to reduce risks related to unsafe food. The general
princi-647 ples of food law may be considered the top of the ideal pyramid of
648 a regulatory food control systems. Regulations and directives have
649 been formulated within this frame.
650 The aim of EU food policy is to assure a high level of food safety,
651 animal health, animal welfare and plant health within the
Euro-652 pean market. In this sense, the General Food Law constitutes the
653 main reference point of the EU food legislation. It applies to all
654 stages of the production, processing and distribution of food and
655 also to feed produced for, or fed to, food producing animals. More
656 in detail, the General Food Law establishes the principles of risk
657 analysis in relation to food and establishes the structures and
658 mechanisms for the scientific and technical evaluations which
659 are undertaken by the European Food Safety Authority (EFSA). As
660 an exception of the general tendency to regulate risks rather than
661 benefits, it is worth mentioning the EFSA health claims procedure
662 under Regulation (EC) No 1924/2006, which plays a relevant role in
663 the regulation of the benefits. Nevertheless, also in this case, we
664 may see that the final objective of regulating benefits turns into
665 the legislative intention to prevent risks, both connected to the
666 functioning of the market and to the consumers’ protection, if we
667 consider that the general objective of the Regulation is to ensure
668 the effective functioning of the internal market as regards nutrition
669 and health claims whilst providing a high level of consumer
pro-670 tection (EC, 2006).
671 Food law, and in particular measures relating to food safety
672 have to be based on scientific expertise. The EU has developed its
673 own risk analysis principles in conformity with the International
674 standards. Regulation EC/178/2002 establishes in EU law that the
675 three phases of risk analysis (risk assessment, risk management
676 and risk communication) provide the basis for food law as
appro-677 priate to the measure under consideration. Therefore, the General
678 Food Law states that scientific assessment of risk must be
under-679 taken in an independent, objective and transparent manner based
680 on the best available science. Risk management is the process of
681 weighing policy alternatives in the light of results of a risk
assess-682 ment and, if required, selecting the appropriate actions necessary
683 to prevent, reduce or eliminate the risk to ensure the high level
684 of health protection determined as appropriate in the EU. In the
685 risk management phase, the decision makers need to consider a
686 range of information in addition to the scientific risk assessment.
687 These include, for example, the feasibility of controlling a risk,
688 the most effective risk reduction actions depending on the part
689 of the food supply chain where the problem occurs, the practical 690 arrangements needed, the socio-economic effects and the environ-691 mental impact. Regulation EC/178/2002 establishes the principle 692 that risk management actions are not just based on a scientific 693 assessment of risk but also take into consideration a wide range 694 of other factors legitimate to the matter under consideration (see 695 http://ec.europa.eu/food/food/foodlaw/principles/index_en.htm). 696 In sum, at a legislative level we may observe that the main 697 objective is to regulate risks connected to unsafe food, rather than 698 benefits and the balance between risks and benefits. Risk manage-699 ment is a procedure which involves legislative tools together with 700 scientific expertise. The choice to regulate risks rather than bene-701 fits is deeply linked to the necessity to reduce the risks on the mar-702 ket by defining the tasks of the European Commission, the 703 European Food Safety Authority(http://www.efsa.europa.eu) and 704 the national competent authorities in charge to implement at local 705 level the European provisions.
706 3. Commonalities and differences, and illustration in a case 707 study
708 This section contains some of the characteristics that the differ-709 ent fields, described in the previous section, share in common and 710 in which they differ with respect tobenefit–riskanalysis. 711 The general settings in whichbenefit–riskanalyses within the 712 different fields currently may take place are described inTable 1. 713 The general characteristics of integrated assessment of benefits 714 and risks within different fields are described inTable 2. In order 715 to illustrate the commonalities and differences, a conceptual case 716 example of replacing animal protein with environmentally more 717 sustainable dietary protein is presented inTable 3. The case exam-718 ple described here is meant as an aid, to illustrate and characterize 719 the different fields that form this paper. The attributes in the ta-720 bles, according to whichbenefit–riskanalysis within the different 721 fields are described, are adapted from the framework applied for 722 characterizing approaches tobenefit–riskanalysis in the field of 723 environmental health inPohjola et al.(2011a))and explained in 724 Table 4.
725 In Section3.1, general commonalities and differences are de-726 scribed, taking the main points fromTables 1 and 2. Issues arising 727 from the illustrative case study in Table 3 are discussed in 728 Section3.2.
729 3.1. General commonalities and differences
730 The purpose ofbenefit–riskmanagement is to arrive at the opti-731 mal decision, while accounting for all relevant issues. The purpose 732 ofbenefit–riskassessment is to provide the science-based informa-733 tion on the integrated benefits and the risks to support in answer-734 ing the benefit–risk management question, i.e. to contribute to 735 evidence-based decision making. The focus ofbenefit–riskanalysis 736 in the different fields is
737 - Food and Nutrition:improving public health/preventing disease 738 by better food and nutrition and generating knowledge for food 739 improvement or innovation and general understanding. 740 - Medicines:curing, slowing or preventing disease by means of 741 medication and monitoring benefit–riskprofiles of marketed 742 medicinal products with or without its impact on budget. 743 - Food Microbiology: preventing foodborne disease caused by 744 micro-organisms and generating knowledge for microbiological 745 product innovation.
746 - Environmental Health:preventing damage to health mediated 747 through the environment, possibly also reducing impact on 748 economy, society and environment.
749 - Economics and Marketing–Finance:optimising public economic
750 policies, corporate investment and marketing strategies.
751 - Consumer Perception: stimulating good food choice by using
752 insights in consumers’ perceptions, attitudes and behaviour
753 relating to a particular case and by increasing acceptance
754 through information, increasing familiarity, reducing
uncer-755 tainty, and product optimization.
756 757 The challenges of aggregating and weighing benefits and risks
758 are shared by the different fields. Two issues coming up in this
con-759 nection are the inclusion of multiple benefits and risks with
differ-760 ent scopes, and the explicit inclusion of subjective information.
761 Among the fields that are considered, assessments in Food and
762 Nutrition, Food Microbiology, Medicines and Environmental Health
763 focus predominantly at health/disease, mostly physical
health/dis-764 ease (though several approaches in Environmental Health are open
765 to also include other domains). Quantitative weighing of benefits
766 and risks via DALYs or QALYs has been performed in Food and
767 Nutrition, Food Microbiology, Environmental Health and in
post-768 marketing modelling studies for Medicines. Mostly this is done
769 within strict and relatively narrow bounds, e.g. focusing on the
770 health effects of food compounds. In Economics and
Marketing–Fi-771
nanceas well as Consumer Perception, health is not the centre of 772 attention. In the latter two, human perception and behaviour is
773 an important topic of investigation, whereas the former four strive
774 for more ‘objective’ health information. However, also there, the
775 influence of perception and behaviour is acknowledged, at least to
776 some degree, e.g. in the form of the placebo effect and compliance
777 to prescriptions or advice. Qualitative comparison and use of expert
778 judgment are part of all fields, but in differing degrees. For example,
779 expert opinions/judgments in different phases have an important
780 role in the progress of medicine benefit–risk analysis along the
781 early stages of drug development. In Food and Nutrition, (expert)
782 value statements are explicitly named only in comparison or
com-783 bination of benefits and risks (e.g. qualitative comparison, and
dis-784 ability weights). Non-expert value judgments are increasingly
785 taken into account particularly in Environmental Health.
786 Another notable issue relates to differences in the valuation of
787 benefits and the acceptability of risks, both by consumers and
788 managers. In Food and Nutrition and Food Microbiology, chemical,
789 biochemical and microbiological risks are not accepted, i.e. food
790 safety issues are minimised to such a low level that risks are
virtu-791 ally absent (see alsoSection2.7). Especially Food Microbiology is
792 illustrative of the important role of ‘risk’ in public health. In
con-793 trast, in many approaches to Environmental Health and in
Medi-794 cines, some risk is accepted for a greater benefit. In Medicines,
795 risk, in the form of adverse drug reactions, is accepted for the
796 greater benefit of recovery or of alleviation of symptoms. Also, by
797 observing the common everyday practices, some degree of risk
798 coming from the environment in the form of traffic, energy
produc-799 tion, radiation,disinfection,etc. can be considered as accepted in
800 order to meet the needs of modern society. However, the
percep-801 tions of such risks may vary significantly among policy makers
802 and the public, and the differing perceptions may not always be
803 backed up with well-reasoned knowledge. Moreover, in Economics
804 andMarketing–Financeand Consumer Perception, (high) risks can
805 be accepted if the expected benefits are higher and at least some
806 degree of risk is accepted as necessary to bring about benefits in
807 general. Some differences with respect to the degree in which risk
808 is accepted and benefit is valued are illustrated inFig. 2. With
re-809 spect to Food and Nutrition, there appears to be a discrepancy:
810 risks brought about by unfavourable nutritional quality and/or
811 quantity of the diet (i.e. unbalanced intake of nutrients and foods
812 resulting in deficiencies and/or chronic disease), are more readily
813 accepted (as voluntary, right to choose) both by consumers and
814 policy makers.
Table 1
Current general setting for benefit–risk analysis within different fields. Attributea
Food and Nutrition Medicines Food Microbiology Environmental Health Economics and Marketing–Finance Consumer Perception
Management question What is the optimal
decision for public health, where and how can the largest net population health gains be realised, with respect to food-related questions, e.g.
- recommendation of
nutrients or foods - policy for fortification
- food processing
methods
- introduction of novel foods
What is the optimal decision for public health, with respect to
- drug safety - drug efficacy
- drug safety monitoring and management
- drug benefit–risk balance - eligible patient populations
What is the optimal decision for public health, with respect to microbial food safety and (to a lesser extent) microbiologically mediated health benefits?
What is the optimal decision for public health when focusing on environmentally mediated direct and indirect health impacts? Can be considered in the context of other issues such as
- economic impacts
- equity and social well-being impacts
- impacts to the environment
What is the optimal utility that market participants derive from outcomes based on benefit–risk trade-offs such as production, costs, sales, or consumption of a food product?
Other issues to be considered: - cognitive vs. affective decision
making
- risk attitudes (RA) and risk per-ceptions (RP) formation - drivers of RA and RP (e.g. trust,
knowledge)
- utilitarian vs. hedonic benefits/ gains
What is the optimal decision from an acceptance perspective (as well as from a health perspective)?
Who will benefit (identification)? How can target groups be reached
(communication/ marketing)? Food production (taste and health optimisation)
Main problem owners and stakeholders
Policy makers (decisions), scientists (assessment)
Policy makers (decisions), scientists (evaluation), pharmaceutical companies (assessment, evaluation), agencies (evaluation, supervision), general practitioners (advice on patient level), patients (decisions)
Policy makers (decisions),
Scientists (assessment)
Policy makers, industry, citizens (decisions), scientists, industry, commerce, in some approachesb, NGOs, citizens, in some approaches anyone (assessment), industry, commerce, NGOs, citizens (evaluation)
Producers, marketers, policy makers, consumers (decisions), financial analysts (assessment of technical feasibility), marketers (assessment of economic feasibility), industry managers and lobby representatives (managerial feasibility) Consumers (decisions, ad hoc assessment), Risk managers, marketers (communication), Policy makers (decisions) Assessment -management interaction
Separate (physically and intellectually), but becoming more interactive
Ranges from separate to intertwined. Also depends on the stage in the marketing process
Functionally separate approaches, increasing consultation and interaction between the two
Approachesbrange from strictly separate to deeply intertwined
Approaches range from aggregate to disaggregate. They involve ad hoc self-assessment in decision situations by consumers. More systematic assessment, often by external assessors regarding policy decisions, marketing decisions, investment decisions
Ad hoc self-assessments by consumers in decision situations, communication of both scientific and marketing information to identified target groups
a
Attributes are explained inTable 4and adapted from the framework applied for characterizing approaches to benefit–risk analysis in the field of environmental health inPohjola et al. (2011a). b
Approach refers to different approaches to making benefit–risk assessments within the field of environmental health, e.g. health impact assessment, REACH, open assessment, etc. (Pohjola et al., 2011a).
M.J. Tijhuis et al. /Food and Chemical Toxicology xxx (2011) xxx–xxx No. of Pages 18, Model 5G 2011 ar ticle in press as: Tijhuis , M .J. , e t al. Lookin g beyond borders: Integrating best practices in benefit–risk analysi s into the field of Food and Chem. Toxicol. (2011) , doi: 10.1 016/j.fct.20 11.11.044
Assessment question - What are the inte-grated health benefits and risks of (a change in) consumption of a food or food compo-nent in a particular population? What is the current state of knowledge regarding a health issue?
- What is the pre-registration risk– benefit profile of a medicine?
- What is the post-registration
risk–benefit profile of a marketed medicine?
- What is the cost-effectiveness of a health technology in a specific population?
What are the qualitative or quantitative microbiologically mediated health risks (and benefits) associated with foodborne microorganisms and food consumption in particular populations?
What are the direct and indirect environmentally mediated health impacts of e.g.
- chemicals or chemical products - policies
- industrial activity - other activities - in principle anything
- Approaches vary significantly in
terms of their inclusiveness/
exclusiveness
- What drives market par-ticipants’ decision mak-ing process and hence
their actual behaviour
under risk?
- -What drives food
pro-ducers’/farmers’ risk–
benefits trade-offs, e.g. regarding the use of opti-mal level of pesticides? - -What drives consumers’
risk–benefit trade-offs, e.g. regarding acceptance
of unfamiliar
technologies?
- What are the charac-teristics of food items
that influence
con-sumers’ perceptions
of benefits and risks,
attitudes and
reactions?
- What is/are the target population(s)?
Measurements of risk Increased disease risk
from food or food component
Adverse drug reactions, drug–drug interactions. misuse, non-compliance
Increased disease risk from foodborne pathogens
Introduction of new and emerging pathogens
Risk of compromised health due to something. Non-health risks caused by the same something
Cognitive and affective information processing regarding market participants risk attitudes and risk perceptions
Consumers’ cognitive and affective information processing regarding perceived risks measured by qualitative and quantitative techniques Measurements of
benefit
Reduced disease risk or improved health state from food or food component
Disease treated, disease progression stopped or slowed by medicines or lowering of risk factor, or increased benefit/cost ratio
Reduced risk from foodborne pathogenic microorganisms. ‘‘True’’ benefit from beneficial micro-organisms. Benefit of microorganisms as human food source
Expected health benefits due to something. Non-health benefits caused by the same something
Effective and efficient handling of risk-bearing activities in which market participants may be engaged at the different channels of the food supply chain
Consumers’ cognitive and affective information processing regarding perceived benefits such as liking, and feeling good about doing the right thing, measured by qualitative and quantitative techniques
Answer - Quantified benefits
and risks
- Comparison with
guidance level or risk threshold
- Quantitative compari-son, Integrated mea-sures (QALYb
, DALYb )
- Quantified benefit and risk
- Integrated measures (QALY,
DALY, cost, mainly in HTA) - Qualitative judgment
- Qualitative compar-ison of benefits and risk
- Quantitative
com-parison using
inte-grated measures
(QALY, DALY)
- Estimates of risks and benefits. - Comparisons and/or aggregated
measures. Mostly quantitative, but qualitative also possible.
Approaches vary greatly in
breadth of inclusion as well
means of weighing and/or
integration.
- Mostly health risk(s) considered in the context of other factors: e.g. other risks, benefits. - Comparison of impacts of
differ-ent policy options or scenarios
- Combination of
qualita-tive and quantitative
analyses of the dynamics
of decision making
process.
- Comparison of actual vs.
perceived behavioural
outcomes
- Accounting for the influ-ence of the unobserved heterogeneity on market participants’ behaviour of the decision context
characteristics and
dynamics, and
behav-ioural anomalies that
may explain several pat-terns/paradoxes in eco-nomic behaviours - Description of con-sumer segments - Strategies for communication
(continued on next page)
M.J. Tijhuis et al. /Food and Chemical Toxicology xxx (2011) xxx–xxx 9 No. of Pages 18, Model 5G 2011 article in press as: Tijhuis , M .J. , e t al. Looking beyond borders : Integrati ng best practic es in benefit–ris k anal ysis into the field of Food and Chem. Toxi col. (2011) , doi: 10.1 016/j.fct.20 11.11.044
