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Doctoral Thesis The Role of Innovation Policy and Science Communication in Accepting New Food Technology September 2020 Doctoral Program in Technology Management Graduate School of Technology Management Ritsumeikan University Mohamed Farid

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Page 1: Doctoral Thesis 2

Doctoral Thesis

The Role of Innovation Policy and Science

Communication in Accepting New Food Technology

September 2020

Doctoral Program in Technology Management

Graduate School of Technology Management

Ritsumeikan University

Mohamed Farid

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Doctoral Thesis Reviewed

by Ritsumeikan University

The Role of Innovation Policy and Science

Communication in Accepting New Food Technology

(食品に関する新技術受容のイノベーション政策と

科学コミュニケーションの役割)

September 2020 2020 年 9 月

Doctoral Program in Technology Management Graduate School of Technology Management

Ritsumeikan University

立命館大学大学院テクノロジー・マネジメント研究科

テクノロジー・マネジメント専攻博士課程後期課程

Mohamed Farid

モハメド ファリド

Supervisor: Associate Professor KODAMA Kota

研究指導教員: 児玉 耕太准教授

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Declaration

I, Mohamed Farid, herby in this document, declare that my own research work stated in

this thesis has never been used to obtain any academic degree from any other university than

Ritsumeikan university. However, some parts of the research results stated in this thesis may have

been published before by me in scientific journals during the course of this doctoral program study

as part of the publication requirements of obtaining a doctoral degree from Ritsumeikan

University.

M. Farid

June 2020

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Abstract

Innovation policy provides an integrated interface between academic research,

technological development, as well as the industrial policy in order to create an inclusive

contributory framework that promotes innovation and solves several societal challenges. Several

governmental entities in Japan, especially METI and MEXT, are thriving to provide innovation

policies that can help developing concrete solutions to several challenges that can be scaled

nationwide in Japan as well as globally. The approach of the respected entities above has moved

forward to influence also other governmental entities to take the same approach, such as MHLW,

MAFF, and CAA.

One of the most pressing challenges globally is hunger and undernourishment, where

nearly 26% of the global population suffer from different levels of food insecurity. In Japan,

although there is a low level of food insecurity, however, Japan is facing a different type of

challenges related to agriculture and food self-sufficiency. The food production in Japan has

dropped from 79% in 1960 to nearly 37% in 2018. With the existence of other social challenges

in Japan, such as the aging population, which followed by the rapid increase of the national medical

care expenditure, Japan has taken several measures and stated policies related to innovation in the

food technologies that can tackle the challenges mentioned above.

Therefore, this research has been formulated to explore further the ability of Japan to grow

in food-related technologies, especially functional food, and genetically edited food. The approach

to achieve the research aim is to study the regulations further and create a comparison between the

regulations in Japan and globally to spot the strong points that can help boost innovative food

industries in Japan. This research helps in providing an answer to three main research questions

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namely; what are the key differences in terms of functional food regulations between Japan and

overseas, what are the key differences in terms of genetically edited food regulations between

Japan and overseas, and what are the factors affecting the genetically edited food acceptance. The

research has utilized a qualitative approach to answer the first and second research questions,

where the third was tackled by the quantitative approach represented in the structural equation

modeling technique.

In terms of function food, after analyzing the regulations in Japan in comparison with the

regulations in the USA, EU, China, Korea, Taiwan, and Singapore. It was found that regulations

in Japan, especially FFC regulation, is becoming the primary regulation in this field, and it is

promoting innovation and the inclusiveness of SMEs as well as the large corporations.

In terms of genetically edited food regulations, after comparing the regulations in Japan in

comparison with regulations in EU and USA, it was also found that the regulations in Japan are

the most encouraging for innovation in this field, since that it does not require further inspection

and labeling process, unlike GMOs. However, the dilemma remains to explore whether consumers

in Japan are willing to adopt genetically edited food products in the future. To tackle this part, an

SEM analysis was conducted by 180 responses examining six factors. The survey was conducted

twice with an intervention in the middle in the form of a presentation to increase the awareness of

genetically edited food. The analysis shows a significant difference in all the factors when

comparing the results before and after the intervention, which emphasizes the role of science

communication in enhancing awareness and increasing the acceptance level.

Overall, the research has emphasized the role of science communication and regulatory

science, in promoting the industry, as well as the role of innovation policy and the collaboration

between different parties to promote innovation in different fields.

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Acknowledgment

I would like to express my sincere gratitude to my research supervisor, Prof. Dr. Kodama,

for his massive contribution and continued support to conduct this research. During the doctoral

program, Prof. Kodama has supported me in becoming a better scientific researcher and provided

guidance and support in every way possible.

I would like to sincerely thank the research committee, especially Prof. Natori and Prof.

Lim, for the constructive feedback and comments during which have massively increased the

quality of the work in this research.

My sincere appreciations to all Ritsumeikan University’s professors, especially for Prof.

Aoyama, Prof. Ishida, Prof. Oda, and Prof, Choi, who have contributed effectively in my

educational journey.

Also, I would like to thank all my colleagues from masters and doctoral degrees and the

members of the Life Innovation Design Laboratory for their continued support and collaboration

during this study, which has significantly raised my awareness about different scientific fields.

I would like to thank all the staff members of the technology management office, the

international students center as well as the research office for their continued support and endless

efforts spent in supporting the administrative matters of this study.

My sincere thanks go to the Japanese Ministry of Education MEXT as well as to the

Japanese Ministry of Foreign Affairs MOFA, for their continued support and for providing

excellent educational opportunities and funding for international researchers and for their

continued efforts in creating a strong connection between Japan and Africa.

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Table of Abbreviations

MOT Technology Management

METI Ministry of Economy, Trade and Industry

MEXT Ministry of Education, Culture, Sports, Science and Technology

MHLW Ministry of Health, Labour and Welfare

MAFF Ministry of Agriculture, Forestry and Fisheries

CAA Consumer Affairs Agency

USA United States of America

EU European Union

FFC Food with Function Claim

SME Small and medium-sized enterprises

GMO Genetically Modified Organism

SEM Structural Equation Modeling

MOFA Ministry of Foreign Affairs

SDG Sustainable Development Goal

UN United Nations

FAO Food and Agriculture Organization

COVID-19 Novel Corona Virus Disease 2019

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UN-DESA United Nations Department of Economic and Social Affairs

UNU-WIDER World Institute for Development Economics Research

GDP Gross Domestic Product

RQ Research Question

IBM International Business Machines “Corporation”

SPSS Statistical Package for Social Sciences “Software”

AMOS Analysis of Moment Structures “Software”

Ver. Version

FOSHU Food for Specified Health Uses

T. Trillion

M. Million

K. Thousand

FHC Food with health claims

FNFC Food with Nutrient Function Claims

Healthy-Do Hokkaido Government-Certified Functional Food

Ex. Example

TOKUHO Tokutei Hokenyo Shokuhin “Health Food”

mg Milligram

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HACCP Hazard Analysis and Critical Control Points

GMP Good Manufacturing Practice

EC European Commission

FDA Food and Drug Administration

DSHEA Dietary Supplement Health and Education Act

MFDS Ministry of Food and Drug Safety

TFDA Taiwan Food and Drug Administration

CFDA China Food and Drug Administration

HAS Health Sciences Authority

SISPQC Safety, Identity, strength, purity and quality

USD United States Dollar

USDA United States Department of Agriculture

WHO World Health Organization

Bt-corn Bacillus Thuringiensis Corn

CRISPR Clustered Regularly Interspaced Short Palindromic Repeats

Cas9 CRISPR associated protein 9

RNA Ribonucleic Acid

DNA Deoxyribonucleic Acid

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GM Genetically Modified

ZFN Zinc Finger Nucleases

TALENs Transcription Activator-like Effect Nucleases

ODM Oligonucleotide Directed Mutagenesis

KN Knowledge

ATT Attitude Towards Technology

TR Trust

PB Perceived Benefits

PR Perceived Risks

WTP Willingness to Purchase

TAM Technology Acceptance Model

UK United Kingdome

KMO Kaiser-Meyer-Olkain

C.R. Critical Ratio

S.E. Standard Error

SRMR Standardized Root Mean Square Residual

RMSEA Root Mean Square Error of Approximation

CFI Comparative Fit Index

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Table of Contents

1. Introduction ............................................................................................................... 1

1.1. Background ........................................................................................................ 1

1.2. Research Aim and Objectives ............................................................................ 2

1.3. Research Questions ............................................................................................ 3

1.4. Research Methodology ....................................................................................... 5

2. Functional Food Regulations ................................................................................... 8

2.1. Background ........................................................................................................ 8

2.2. Introduction ........................................................................................................ 8

2.3. Regulations in Japan ....................................................................................... 13

2.3.1. Food for Specified Health Use (FOSHU) .................................................... 14

2.3.2. Food with Nutrient Function Claims (FNFC) ............................................. 18

2.3.3. Food with Function Claims FFC ................................................................. 20

2.3.4. Japanese Local Government Regulation System ......................................... 22

2.4. Functional Food Global Regulations ............................................................. 25

2.4.1. Regulators .................................................................................................... 25

2.4.2. Product Categorization ................................................................................ 25

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2.4.3. Shape Description ........................................................................................ 26

2.4.4. Product Purpose .......................................................................................... 26

2.4.5. Positive List .................................................................................................. 27

2.4.6. GMP System – Good Manufacturing Practice ............................................ 27

2.5. Functional Food Regulations Conclusion ...................................................... 28

3. Genetically Edited Food Regulations ................................................................... 31

3.1. Background ...................................................................................................... 31

3.2. Genetically Modified Food .............................................................................. 31

3.3. Genetically Edited Food ................................................................................... 33

3.4. GMO and Gene-Edited Foods Regulations .................................................... 35

3.4.1. Japan's Regulations ..................................................................................... 36

3.5. Conclusion ........................................................................................................ 39

4. Genetically Edited Food Acceptance .................................................................... 42

4.1. Background ...................................................................................................... 42

4.2. Survey Design ................................................................................................... 42

4.3. Responses Collection ....................................................................................... 45

4.4. Survey Demographics ...................................................................................... 46

4.5. Theoretical Model and Literature Review ....................................................... 48

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4.6. Analysis of the Data ......................................................................................... 66

4.6.1. Validity and Reliability of the Constructs .................................................... 67

4.7. Model Testing ................................................................................................... 71

4.8. Initial analysis for model’s constructs ............................................................ 73

4.9. Model’s Path Coefficient ................................................................................. 79

4.10. Model’s Goodness of Fit .............................................................................. 81

4.11. Willingness to Adopt .................................................................................... 85

4.12. Effect of knowledge and science communication ....................................... 87

4.13. Intervention Analysis ................................................................................... 97

5. Conclusion ............................................................................................................... 98

5.1. Research Summary and Conclusion ............................................................... 98

5.2. Research Significance and Implications ....................................................... 102

5.3. Limitations and Opportunities for Future Research .................................... 105

References ...................................................................................................................... 109

Appendix 1: How importance the food security in the SDG ..................................... 123

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List of Tables

Table 1 | Summarized research methodology ................................................................................ 7

Table 2 | Estimates of National Medical Care Expenditures in Japan (Source: MHLW) ............ 10

Table 3 | Estimates of National Medical Care Expenditures in Japan (Source: World Bank) ..... 12

Table 4 | Sample of the approved FOSHU products ingredients (Source: MHLW) .................... 17

Table 5 | Specifications of the authorized claim for FNFC food products (Source: MHLW) ..... 19

Table 6 | Summarized description for functional food categories in Japan ................................. 24

Table 7 | Summarization for the global functional food regulations (Source: Farid, et al. 2019) 30

Table 8 | Genetically Modified and Genetically Edited Foods Regulations Comparison (Source: Farid, et al., 2020) ......................................................................................................................... 41

Table 9 | List of questions related to the Knowledge construct (Farid, et al., 2020) ................... 53

Table 10 | List of questions related to the “Attitude Towards Technology” construct (Farid, et al., 2020) ....................................................................................................................................... 57

Table 11 | List of questions related to the “trust” construct (Farid, et al., 2020) ......................... 60

Table 12 | List of questions related to the “perceived benefits” construct (Farid, et al., 2020) ... 62

Table 13 | List of questions related to the “perceived risks” construct (Farid, et al., 2020) ........ 64

Table 14 | List of questions related to the “willingness to purchase” construct (Farid, et al., 2020)....................................................................................................................................................... 66

Table 15 | Exploratory Factor Analysis ........................................................................................ 68

Table 16 | Kaiser-Meyer-Olkin KMO test, results guideline ....................................................... 69

Table 17 | KMO and Bartlett’s Test Results ................................................................................ 70

Table 18 | Reliability Values of Model’s Constructs ................................................................... 71

Table 19 | Model’s estimated regression weights (before intervention) ...................................... 72

Table 20 | Model’s estimated regression weights (after intervention) ......................................... 73

Table 21 | estimated regression weights for the “knowledge” construct (after intervention) ...... 74

Table 22 | estimated regression weights “attitude towards technology” (after intervention) ...... 75

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Table 23 | estimated regression weights for the “trust” construct (after intervention) ................. 76

Table 24 | estimated regression weights for the “perceived benefits” construct (after intervention) .................................................................................................................................. 76

Table 25 | estimated regression weights for the “perceived risks” construct (after intervention) 77

Table 26 | estimated regression weights for the “willingness to purchase” construct (after intervention) .................................................................................................................................. 78

Table 27 | Acceptable fit rules for selected factors ...................................................................... 82

Table 28 | Model fit index ............................................................................................................ 84

Table 29 | Willingness to purchase binary question responses table ........................................... 85

Table 30 | Willingness to purchase binary question (chi-square test) .......................................... 86

Table 31 | Comparison for the intervention significance for the knowledge construct ............... 89

Table 32 | Comparison for the intervention significance for the attitude towards technology construct ........................................................................................................................................ 90

Table 33 | Comparison for the intervention significance for the trust construct .......................... 92

Table 34 | Comparison for the intervention significance for the perceived benefits construct .... 93

Table 35 | Comparison for the intervention significance for the perceived risks construct ......... 95

Table 36 | Comparison for the intervention significance for the willingness to purchase construct....................................................................................................................................................... 97

Table 37 | Poverty rate prediction post-COVID-19 ................................................................... 125

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List of Figures

Figure 1 | Health and functional food categories in Japan chart (Source: MHLW, CAA) .......... 13

Figure 2 | FOSHU products approval flow chart (Source: MHLW, CAA) ................................. 15

Figure 3 | FOSHU regulations subcategories (Source: MHLW) ................................................. 17

Figure 4 | Accumulative number of FOSHU and FFC authorized products in Japan (Source: CAA, MHLW) .............................................................................................................................. 22

Figure 5 | How genome editing (CRISPR) works ........................................................................ 34

Figure 6 | Data collection session design ..................................................................................... 44

Figure 7 | Diagram explaining the number of survey respondents .............................................. 46

Figure 8 | Demographics of survey’s respondents ....................................................................... 47

Figure 9 | Conceptual model to be tested in this study ................................................................ 49

Figure 10 | Attitude model for genetically modified food (Christoph et al., 2008) ..................... 51

Figure 11 | Level of knowledge associated with certain hazards ................................................. 52

Figure 12 | Categorization of products adopters .......................................................................... 54

Figure 13 | Estimated attitude model towards GM food (Dane mark, Germany, UK) (Bredahl, 2001) ............................................................................................................................................. 62

Figure 14 | Path coefficient using benefits risk analysis model (China) (Zhang et al., 2018) ..... 64

Figure 15 | Path coefficient using benefits risk analysis model (Taiwan) (Chen & Li, 2007) ..... 65

Figure 16 | Model’s standardized estimates based on the data before the intervention ............... 80

Figure 17 | Model’s standardized estimates based on the data after the intervention .................. 81

Figure 18 | Willingness to purchase binary question chart .......................................................... 86

Figure 19 | Respondents mean-line before and after intervention (Knowledge) ......................... 88

Figure 20 | Respondents mean-line before and after intervention (Attitude towards technology)....................................................................................................................................................... 89

Figure 21 | Respondents mean-line before and after intervention (Trust) ................................... 91

Figure 22 | Respondents mean-line before and after intervention (Perceived benefits) .............. 92

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Figure 23 | Respondents mean-line before and after intervention (Perceived risks) ................... 94

Figure 24 | Respondents mean-line before and after intervention (Willingness to purchase) ..... 96

Figure 25 | The Sustainable development goals map ................................................................. 123

Figure 26 | Distribution of food insecurity level in different regions (FAO, 2020) ................... 128

Figure 27 | Food insecurity level by percentage in different regions (2014 – 2018) ................. 129

Figure 28 | Expected increase in the number of undernourished people after COVID-19 (FAO, 2020) ........................................................................................................................................... 129

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1. Introduction

1.1. Background

The world is facing tremendous population growth (Benna & Garba, 2016). Over the past

70 years, the World population has tripled. During the year 1950, the world population was about

2.5 billion people (Demeny & McNicoll, 2006). However, now in the year 2020, the world

population is estimated by 7.8 billion people (Jensen & Levin, 2020). The world population will

continue to grow by approximately 1% a year to reach 8.5 billion in the year 2030. Studies

expected the population to grow further to reach 9.7 billion by the year 2050 and will increase to

11.2 billion by the year 2100 (United Nations, 2013). The tremendous population growth will

continue to create a challenge, especially in providing enough supply of food to the future

population. Food security is one of the main challenges that the world is currently facing. Due to

the importance of the food-related challenges, the United Nations (UN), has allocated the “Zero

Hunger” goal as the second goal of the Sustainable Development Goals (SDGs) (Blesh et al.,

2019). According to the latest estimates from The Food and Agriculture Organization (FAO), over

700 million people around the world who represent nearly 9% of the world population, have

suffered from stringent levels of food insecurity in the year 2018 (Tacon, 2018). FAO has defined

the status of severe food insecurity as the people who did not have any access to any type of food

for a day or more. Another study from FAO shows that additional 1.3 billion people representing

another 17% of the world population have suffered from moderate levels of food insecurity,

represented in the lack of having continuous access to sufficient level of nutritional food. However,

the situation in Japan is different. Although Japan has a very low level of food insecurity yet, Japan

has a low level of food self-sufficiency when comparing the food imports to the exports where it

was dropped by nearly 55% during the past 60 years reaching an all-time low of 37% (Farina,

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2017). Also, in Japan, the number of farming households has dropped by nearly 90% in the last 50

years from 11 million in the year 1965 to 1.3 million in 2015, where currently 60% of the farmers

in Japan are aged above 65 years old. Another challenge is also represented in the fact that the

percentage of arable land in Japan is minimal, specifically below 12%.

Based on the above challenges mentioned in the world in general and Japan in specific,

there is an urgent need to focus on solving food security and food self-sufficiency challenges,

which can be solved by utilizing different food technologies namely functional food and

biotechnology (Jamil, 2009) represented in genetically edited food.

Japan also has a very high level of R&D in different fields, which can be utilized in solving

such pressing challenges and boost Japan as an innovation hub in the area of food technologies

locally and globally.

1.2. Research Aim and Objectives

As we have discussed earlier in the background part, there is a continued need for food-

related technologies for providing food for everyone at a low cost. Also, although Japan is

currently facing several challenges related to agriculture, however, Japan has an opportunity to

excel further in the food-related technology field, such as functional food and genetically edited

food. Functional food in the United States, considered as a growing industry, where the industry

grows by nearly 10% yearly. However, the situation in Japan is quite different, where the industry

grows by almost 2% only yearly. This considered very challenging for the Japanese sector due to

the high cost associated with research and development.

Therefore, and in order to support tackling the above-mentioned challenges, this research

has been formulated with the explicit aim of exploring how Japan can grow in the field of

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innovative food technologies with a focus on “Functional Food” and “Genetically Edited Food”

products.

The approach to achieve the research aim is to study the regulations further and create a

comparison between the regulations in Japan and globally to spot the strong points that can help

boost innovative food industries in Japan. Also, the regulation comparison can help the Japanese

food industry to expand globally with a clear understanding of the regulatory challenges in

different countries. In order to achieve the research aim, the following research objectives were

set:

• Compare the functional food regulations in Japan and globally.

• Discuss how different regulations in Japan can boost innovation.

• Compare the genetically edited food regulations in Japan and globally.

• Explore how to increase the acceptance of innovative food technologies-based

products “genetically edited food” among consumers in Japan.

1.3. Research Questions

Given in consideration the background of this study and the highlighted research problem,

there is a need to create a better understanding of different opportunities that can help the Japanese

companies grow in the field of food-related technologies. Therefore, formulating the research

questions have followed three stages.

The first stage is studying the functional food in Japan and globally since that functional

food is considered as very common in Japan with a considerably acceptable level of knowledge

among the manufacturers. Therefore, the first research question was formulated to investigate how

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Japan can expand globally in the field of functional food by reviewing the global regulations in

this regard.

• RQ1: What are the key differences in terms of functional food regulations between

Japan and overseas?

The following stage after studying the functional food regelation is to target a more

innovative field of food technologies where the global market has excellent opportunities with low

competition as well. In this stage, the main focus was “genetically edited food” since it is a very

innovative industry and meets the requirements mentioned earlier. To explore the possibilities of

growing the Japanese sector locally and globally in the field of genetically edited food, the local

and global regulations for this regard have been the focus of this part. Therefore, the second

research question was stated as follows;

• RQ2: What are the key differences in terms of genetically edited food regulations

between Japan and overseas?

The third stage, after studying the genetically edited food regulations in Japan and globally,

aims to investigate the possibility of growing the genetically edited food industry, which needs to

improve the acceptance of the genetically edited food in the first place. Therefore, in this stage,

we wanted to discover further what are the factors that affect the acceptance and adoption rate of

the genetically edited food products, so the following research question was formulated.

• RQ3: What are the factors affecting genetically edited food acceptance?

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Finding scientific answers for the three research questions mentioned above shall create

collective knowledge and set a basic understanding of the possibilities to grow the Japanese

innovative food industry locally and globally.

1.4. Research Methodology

In order to achieve the research aim and find an answer to the above-mentioned research

questions, a mixed methodology has been applied to this research combining the qualitative

approach along with the quantitative approach.

The first research question aims to create a better understanding of the difference between

the regulations in Japan and the regulations globally in terms of functional food. Therefore, the

qualitative approach has been used to tackle this question by conducting a literature review and

review for secondary data represented in the previous studies and governmental legislation reports.

In this part of the study, the Japanese regulations were studied based on the latest updates and

using four different types of regulations in Japan. The Japanese regulations were also compared

with the regulations in the United States, European Union, Korea, Taiwan, China, and Singapore.

The second research question aims to investigate a more innovative industry, which is the

genetically edited food industry, and to create a better understanding of the difference between the

regulations in Japan that govern genetically edited food and the regulations globally in this regard.

Therefore, the qualitative approach has been used in this segment as well, represented in literature

reviews and analysis for the official reports and legislation as well as the press releases of the

regulatory authorities in Japan, America, and the European Union.

The third research question aims to investigate more the willingness to accept genetically

edited food products in Japan. Therefore, in this part, a qualitative approach was utilized in the

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form of a survey and experiment. For the survey part, the structural equation modeling method

was utilized in order to investigate further the different factors that affect the willingness to

consumer genetically edited food products in Japan. The main factors studied in this part were six

factors, namely; knowledge, attitude towards technology, perceived benefits, perceived risks, trust,

and willingness to purchase. Each factor of the six factors mentioned above was measured using

seven different questions.

Due to the fact that genetically edited food is considered a new term, and there is a lack of

knowledge about it among the general consumers including the survey respondents, an experiment

was designed in the form of intervention to increase the knowledge of the respondents about the

genetically edited food and how it is different than genetically modified food. Therefore, the survey

was conducted twice in the same session, with having an intervention in the form of a five-minute

informative presentation between each run of the survey. The questions before and after the

intervention were identical, since that the main focus in this step was to investigate the role of

knowledge and science communication in increasing the awareness and the acceptance rate by

comparing the willingness to adopt genetically edited food products data before and after the

intervention. The correct and complete samples of the respondents who answered both surveys

were 180 respondents, with an average age of 21 years old, who are bachelor’s degree students,

studying business administration at Ritsumeikan University, Japan. All the analyses for the surveys

have been conducted using IBM SPSS and IBM SPSS Amos (Ver. 26).

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Table 1 | Summarized research methodology

RQ1 RQ2 RQ3

Question

What are the key

differences in terms of

functional food

regulations between

Japan and overseas?

What are the key

differences in terms of

genetically edited food

regulations between Japan

and overseas?

What are the factors

affecting genetically

edited food acceptance?

Focus Functional Food Genetically Edited Food Genetically Edited Food

Aim Regulation comparison Regulation comparison Explore factors affects the

acceptance

Approach Qualitative Qualitative Quantitative

Methodology Literature

review

Literature

review

Structural equation

modeling SEM

Data Source

Previous study and

governmental legislation

reports

Previous study and

governmental legislation

reports

Survey and

experiment

Data Points

Regulation of Japan,

USA, EU, Korea, Taiwan,

China, Singapore

Regulation of Japan,

USA, EU

SEM Factors:

Knowledge, Trust,

Perceived Benefits,

Perceived Risks, Attitude

Towards Technology,

Willingness to Purchase.

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2. Functional Food Regulations1

2.1. Background

This chapter focuses mainly on the first research question (What are the key differences in

terms of functional food regulations between Japan and overseas?). The study focuses on this

chapter to identify the different regulations of the functional food in Japan, also the regulations for

the labeling of functional food globally, especially in the United States, European Union, China,

Korea, Taiwan, and Singapore. The study in this chapter comes as part of the main aim of this

research of exploring ways to expand the Japanese functional food products globally. To achieve

this aim, we have studied in this chapter the local and global functional food markets as well as

the regulations to point out the strengths and opportunities for the Japanese functional food systems

to expand abroad. This chapter focuses mainly on the literature review and the secondary sources

represented in the governmental regulation reports and press releases.

2.2. Introduction

Food is a human necessity. It provides our daily lives with nutrients and energy. Cooking

has, however, become "functional food," which changes health benefits and nutritional benefits.

Functional foods have now advanced to the point where they can be designed to improve public

health and reduce the likelihood of having specific types of diseases. Functional foods can be

defined as foods or beverages that have boosted nutrients such as vitamins, fibers, proteins,

minerals, or other functional components. Functional foods can operate in two ways. The first way

is by enhancing existing ingredients, where the second way is by incorporating one or more new

ingredients to improve non-original food functions (Hasler, 2002). Functional food producers

1 This section may include an adaptation of Farid, et al., 2019

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follow specific processes to ensure products with true values are produced. Most regulators around

the world are drafting rigorous and detailed regulations and standards to ensure food efficiency

and safety. Regulatory bodies may also study whether the goods offer real value to consumers.

Legislations vary from country to country, making exporting functional foods a challenging task,

especially if the regulations are not clear or if the goods have not been modified to fit the importing

country's regulations. Functional food has continued to deliver true added value for a wide

spectrum of customers, especially among senior citizens, since its inception in Japan. In the 1980s,

Japan introduced the term "functional foods," followed by legislation for it. In Japanese economics

and society, functional food has become important. With rising healthcare costs and the resulting

financial burdens facing Japan, including welfare programs for senior citizens and others with

chronic diseases, adopting healthy and functional foods at the earliest possible age can limit the

possibility of acquiring diet-related diseases, thereby reducing the cost of national health

expenditure (Bagchi, 2008).

The national health expenditure rate in Japan is on a continuous rise. In the year 1987, the

total national healthcare-related expenditure in Japan was valued with almost eighteen trillion

Japanese yen, with an approximated expenditure per capita of 147,000 Japanese yen per year.

However, thirty years later and specifically in the year 2017, the total expenditure has surpassed

the forty-three trillion Japanese yen a year, and reached to nearly 340,000 Japanese yen per capita.

Such a massive increase in the healthcare cost of nearly 130% over the past thirty years have

created economic consequences in Japan, as shown in the table below.

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Table 2 | Estimates of National Medical Care Expenditures in Japan (Source: MHLW)

Total Expenditure (Trillion JPY)

Increase compared to the previous year (%)

Expenditure per capita (Thousand JPY)

1987 18.08 5.9 147.8

1988 18.76 3.8 152.8

1989 19.73 5.2 160.1

1990 20.61 4.5 166.7

1991 21.83 5.9 176

1992 23.48 7.6 188.7

1993 24.36 3.8 195.3

1994 25.79 5.9 206.3

1995 26.96 4.5 214.7

1996 28.45 5.6 226.1

1997 28.91 1.6 229.2

1998 29.58 2.3 233.9

1999 30.7 3.8 242.3

2000 30.14 1.8 237.5

2001 31.1 3.2 244.3

2002 30.95 0.5 242.9

2003 31.54 1.9 247.1

2004 32.11 1.8 251.5

2005 33.13 3.2 259.3

2006 33.13 0.0 259.3

2007 34.14 3.0 267.2

2008 34.81 2.0 272.6

2009 36.01 3.4 282.4

2010 37.42 3.9 292.2

2011 38.59 3.1 301.9

2012 39.21 1.6 307.5

2013 40.06 2.2 314.7

2014 40.81 1.9 321.1

2015 42.36 3.8 333.3

2016 42.14 (0.5) 332.0

2017 43.07 2.2 339.9

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Japan’s Ministry of Health and Welfare has created the term Food for Specified Health Use

FOSHU in an effort to create appropriate legislation to accredit functional food products and verify

their commercialization. The share of functional foods on the global market is rapidly increasing.

The market recorded $300 billion in revenue in 2017 and is expected to grow to $440 B in 2022.

The Asia - Pacific region has a market share of 34%, followed by North America of 25%, Latin

America of 17%, Western Europe of 16%, Eastern Europe of 3%, Middle East and Africa of 3%,

and Australia and New Zealand of 2%. While the US has the highest country market share, the

Asia - Pacific region has more regional market share. Japan is currently leading the way, with a

market size ranging from $30B to $40B. The US market, however, is growing rapidly, with rates

exceeding 10 percent per year. In contrast, Japan's market shows a much lower level of growth of

less than 2 percent per annum.

We take the age-dependence ratio as an important measure when analyzing the key

demographics of potential markets for functional food. The age-dependence ratio is the ratio of the

older dependents (people over 64) to the working-age population (people between 15 and 64). It

measures the proportion of society's elderly portion as relative to those of working age. A high

ratio indicates that a large segment of the population depends on the workforce to meet the

healthcare and other needs of the senior population. In societies with high elderly population rates,

innovative measures need to be taken to minimize social service costs without reducing service

levels. To measure changes over the past fifty years, a comparison was created between the age

dependency ratio for the years 1967 and 2017. Generally speaking, the countries in our comparison

all display rises in the dependence of the elderly vary widely from country to country. The lowest

rise in the United States was up from 15.9% in 1967 to 23.4% in 2017, a 47% leap. By contrast,

Japan's highest growth was from 9.3 percent in 1967 to 45 percent in 2017, with a massive 383.9

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percent increase. The EU increased by 78.4%, Korea increased by 193.8%, Taiwan by 170%,

China by 131.3%, and Singapore by 244.2%. While the EU has a ratio of 30.5 percent for 2017

(higher than the Asian countries excluding Japan), Europe has experienced a low level of growth

compared to Asian countries over the past 50 years. This implies that, generally, the Asian

countries have seen major demographic change over the last few decades.

We believe the Asian functional food markets must continue to grow to cope with the high

medical and social expenditures associated with these changes. In addition, markets such as China,

with a total population of 1.37 billion, already have tremendous opportunities in this area,

compounded by the rapid increase in the age dependency ratio (14.8 percent in 2017, with a 50-

year leap of 131.3 percent). There is no doubt that the growing elderly dependency ratio is partially

due to healthcare services that have increased the average life expectancy. In 2017, average life

expectancy in Japan reached close to 84 years.

Table 3 | Estimates of National Medical Care Expenditures in Japan (Source: World Bank)

Variable Japan US EU China Korea Taiwan Singapore

Population (M) 126.9 323.4 511.2 1,378.6 51.2 23.5 5.6

GDP ($. T.) 4.9 18.6 16.4 11.1 1.4 0.4 0.3

GDP per Capita ($. K.) 38.9 57.5 32.2 8.1 27.6 25.5 55.2

Life Expectancy (year) 83.9 78.6 80.6 76.2 82 80.4 82.7

Age dependency ratio, old* (%) Year 2018

46.17 24.14 30.86 15.33 19.85 18.9 15.03

Age dependency ratio, old* (%) Year 1967

9.3 15.9 17.1 6.4 6.5 7.0 (est.) 5.2

Increase in age dependency over 50 years (%)

383.9 47.2 78.4 131.3 193.8 170 244.2

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2.3. Regulations in Japan

There is a clear distinction between the categories of health food and pharmaceutical.

While the health food category is specialized in providing modified or enhanced food to provide

healthier nutrition, the pharmaceutical category is specialized for products that can cure or prevent

diseases. The group of health foods is composed of two major subcategories. The first consists of

the so-called "health food," which is considered a grey zone with vague requirements for labeling

and descriptive definitions. The second category which is the subject of this study is "health and

functional food" or food with health claims (FHC) which is highly regulated by the Japanese

authorities and is further divided into three subdomains: Foods for Specified Health Use (FOSHU),

Food with Nutrient Function Claims (FNFC), and Food with Function Claims (FFC). Along with

the three categories mentioned above, there is another category related to the local government

system certification, where local governments can certify a product as a functional food

considering that it matches with certain standards. One of the well-known systems in this category

is Healthy-Do, which is the official local government certification system in the prefecture of

Hokkaido in Japan.

Figure 1 | Health and functional food categories in Japan chart (Source: MHLW, CAA)

Health Food

Health and functional food Pharmaceutical

So-called “Health food”

Gray Zone

FFC Food with

Function Claims

Notification system

FNFC Food with

Nutrient Function Claims

Self-

Authentication system

FOSHU Food for

Specified Health Use

Individual Permission restraints

Pharmaceutical

including quasi-drugs

Local Government System (local certification system)

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2.3.1. Food for Specified Health Use (FOSHU)

FOSHU, "Foods for Specified Health Use," also which is known as TOKUHO, is a

Japanese abbreviation for "tokutei hokenyo shokuhin," or foods with special healthy qualities. The

Ministry of Health, Labour and Welfare (MHLW) in Japan introduced those laws in 1991. This

system requires that each product be given special testing procedures to obtain labels approval.

The research relating to food labeling was moved to the Consumer Affairs Agency (CAA) after 1st

of September 2009.

The approval procedure for this functional food category uses strict standards, and it

requires massive financial investment and a lengthy review period. It poses affordability and time-

to-market challenges for smaller companies or start-ups, which gives big companies a competitive

advantage. Such products have different labeling to reflect the product 's claim and functions, such

as identifying ingredients that affect body functions (e.g., stabilizing blood pressure, reducing

cholesterol). To get a product licensed, the applicant must submit the application forms for

approval to apply for review requests. Within the CAA, three entities review the request for

permission; the Consumer Commission, the Food Safety Committee, and the Health Ministry. A

sample of the food product to be tested by the National Institute of Health and Nutrition or another

approved and licensed inspection agency must be submitted by the applicant.

As shown in the figure below, the process for getting FOSHU approval is considered to be

lengthy with a high number of stakeholders involved. The figure shows a clear process for the

FOSHU applicant to follow in order to get the authorization needed for product commercialization.

As shown in the figure below, there are several other stakeholders involved in the process beside

the CAA and MHLW.

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Figure 2 | FOSHU products approval flow chart (Source: MHLW, CAA)

Applicant

Display permission application form

Application form for examination

Sample of the product for testing

Public Health Office

Prefectural government Designated cities

Consumer Affairs Agency CAA

Consumer Committee

Food Safety Committee

Ministry of Health,

Labor and Welfare

National Institute of Health and Nutrition

or other registered entity

Apply

Send

Process Send the permission

Permission notice

Deliver

Apply

Request analysis

Analysis Results

Submit Analysis Results

Consult Report

Consult Report

Consult Report

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As shown in the figure above, for a product to be approved as a FOSHU product, it has to

go through a lengthy process, and it has to match very strict requirements. The first requirement

that the product must demonstrate a high level of effectiveness on the human body. Also, the

product must have very high safety standards, which can be verified by toxicity tests on animals,

also by verifying the potential effect of any excessive intake cases. The product must have balanced

level ingredients with appropriate use of nutrition. Also, the product must maintain its capabilities

and specifications by the time the consumer expected to use it. Also, the product must follow

quality control and quality assurance strict systems in order to verify the ingredients and product

specifications to be at the authorized level.

The FOSHU category consists of 4 subcategories, as represented in the figure below. Along

with the regular category, there are three different categories, namely: qualified, standardized, and

reduction of disease risk. The qualified FOSHU, which represents food with health features that

are not based on scientific evidence that meets the FOSHU level or food with a certain efficacy

but without a proven mechanism of the successful functional item, will be accepted as an eligible

FOSHU product. The standardized FOSHU category represents when standards and specifications

for foods with sufficient FOSHU approvals are established, and scientific evidence is accumulated.

Standardized FOSHU is approved when it meets the specifications and standards. The last category

is the reduction of disease risk category, which was added to the FOSHU regulation by the MHLW

in accordance with the decision of the Codex Alimentarius Commission of the Food and

Agricultural Organization / World Health Organization. This category contains products that have

ingredients proven to reduce the risk of certain diseases such as calcium or folic acid, which can

be used with specific daily intake specifying the recommended minimum and maximum daily

intakes. The ingredients for this category in specific should be completely based on strong

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scientific evidence in which the scientific community has consensus to approve it, as shown in the

table below.

Figure 3 | FOSHU regulations subcategories (Source: MHLW)

Table 4 | Sample of the approved FOSHU products ingredients (Source: MHLW)

Specified Health Uses Principal Ingredients (ingredients exhibiting health functions)

Foods to modify gastrointestinal conditions

Oligosaccharides, lactose, bifidobacteria, lactic acid bacteria, dietary fiber 8 ingestible dextrin, polydextrol, guar gum, psyllium seed coat, etc.)

Foods related to blood cholesterol level Chitosan, soybean protein, degraded sodium alginate

Foods related to blood sugar levels Indigestible dextrin, wheat albumin, guava tea polyphenol, L-arabiose, etc.

Foods related to blood pressure Lactotripeptide, casein dodecaneptide, tochu leaf glycoside (geniposidic acid), sardine peptide, etc.

Foods related to dental hygiene Paratinose, maltitiose, erythrytol, etc.

Cholesterol plus gastrointestinal conditions, triacylglycerol plus cholesterol Degraded sodium alginate, dietary fiber from psyllium seed husk, etc.

Foods related to mineral absorption Calcium citrated malate, casein phosphopeptide, hem iron, fracuto-oligosaccharide, etc.

Foods related to osteogenesis Soybeen isoflavone, MBP (Milk basic protein), etc.

Foods related to triacylglycerol Middle chain fatty acid, etc.

Source: Japanese Ministry of Health, Labour and Welfare of Japan (Website)

Regular Reduction of Disease Risk

Food for Specific Health Use (FOSHU)

Qualified Standardized

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2.3.2. Food with Nutrient Function Claims (FNFC)

FNFC, "Food with Nutrient Function Claims," which was introduced by the MHLW in

April 2001, is another type of the Japanese national functional food regulations. The FNFC

contains all foods that have been labeled with nutrient role statements meeting the guidelines of

the MHLW. Yet again, after 2009, the procedure is regulated by the CAA. The FNFC standards

specify several ingredients that may be used, including thirteen vitamins, beta carotene, six

minerals, and n-3 fatty acids. The key difference between the FNFC and the FOSHU is that the

former does not need any approval from the CAA as long as the product manufacturer ensures that

the product meets the requirements and specifications, unlike the accreditation and certification

process under FOSHU. The FNFC regulations do not require getting a particular logo or credential

on the product. However, the nutrient function claims, as well as the warning indications, must be

clearly displayed on the product. It is not allowed to label the FNFC products as products useful

for a specified healthcare-related purpose. An example of the FNFC labeling is the identification

of the nutritional ingredient as "Vitamin C," with a specified range of 24 ~ 1000 mg of

recommendable daily intake. The functional claims would be "helps to maintain skin and healthy

mucosa, and has an antioxidant effect." A warning would be, "Increased intake of this product will

not result in disease cure or health promotion, please comply with the advisable daily intake."

The table below shows a list of the functional ingredient allowed to be used in the FNFC

category, with its advisable daily intake, as well as the translated meaning of the functional claim

of the labels, which were translated from Japanese to English.

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Table 5 | Specifications of the authorized claim for FNFC food products (Source: MHLW)

Functional Ingredient

Advisable daily intake

Approximate “translated” meaning of the nutrient functional claim

Niacin 3.3 ~ 60 mg Niacin is a nutrient that helps maintain healthy skin and mucous membranes

Pantothenic acid 1.65 ~ 30 mg Niacin is a nutrient that helps maintain healthy skin and mucous membranes

Biotin 14 ~ 500 μg Biotin is a nutrient that helps maintain healthy skin and mucous membranes

Vitamin A 135 ~ 600 μg Vitamin A is a nutrient that helps maintain night vision. Vitamin A is a nutrient that helps maintain healthy skin and mucous membranes

Vitamin B1 0.30 ~ 25 mg Vitamin B1 is a nutrient that helps produce energy from carbohydrates and maintain healthy skin and mucous membrane

Vitamin B2 0.33 ~ 12 mg Vitamin B2 is a nutrient that helps maintain healthy skin and mucous membranes

Vitamin B6 0.3 ~ 25 mg Vitamin B6 is a nutrient that assists in energy production from proteins and helps in maintaining healthy skin and mucous membranes

Vitamin B12 0.60 ~ 60 μg Vitamin B 12 is a nutrient that assists the formation of red blood cells

Vitamin C 24 ~ 1000 mg Provides an anti-oxidizing effect, also assist in maintaining skin and mucosa healthily

Vitamin D 1.5 ~ 5.0 μg Vitamin D is a nutrient that promotes the absorption of calcium in the intestinal tract and helps bone formation.

Vitamin E 2.4 ~ 150 mg Vitamin E is a nutrient that protects the lipids in the body from oxidation and helps maintain the health of cells through its antioxidant effect.

Folic acid 60 ~ 200 μg Folic acid is a nutrient that helps the formation of red blood cells also it contributes to the normal development of the fetus.

Zinc 2.1 ~ 25 mg

Zinc is a nutrient needed to maintain a normal taste. Zinc is a nutrient that helps maintain healthy skin and mucous membranes. Zinc is a nutrient that is involved in the metabolism of proteins and nucleic acids and helps maintain good health.

Calcium 210 ~ 600 mg Calcium is a nutrient required for bone and tooth development

Iron 2.25 ~ 10 mg Essential for red blood cell formation process

Copper 0.18 ~ 6 mg helps to form red blood cells and helps maintaining several body enzymes in functioning properly, as well as in bone formation

Magnesium 75 ~ 300 mg Essential in the bone and teeth development Helps in keeping appropriate blood circulation helps proper function of many body enzymes

Source: Japanese Ministry of Health, Labour and Welfare of Japan (Translated from Japanese)

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2.3.3. Food with Function Claims FFC

In April 2015, Japan also introduced a new form of legislation called the Food with

Function Claims (FFC). That category requires a company to mark the food if the company has

provided a report to the CAA stating that the goods meet national specifications, comply with

health and safety guidelines and provide medical evidence for the reported functions obtained from

clinical trials of humans to check their efficacy. The trials have to be carried out in systematic

studies by specialists and experts. The food business operator is expected to send this form of

notice to the CAA Secretary-General at least sixty days before the launch date or before any

marketing campaigns for the product are being conducted. The products must also have packages

labeled that comply with the Food Labeling Act and the Notification Guidelines for Products with

Function Claims. The labeling procedures include that the label has to be in the Japanese language

and include essential details such as the key ingredients, the process for using essential warnings,

suggested regular usage, and the manufacturer's contact information.

Category FFC may be used with all food products, including fresh vegetable products but

excluding products already registered under FOSHU or FNFC; this label also excludes all

alcoholic beverages and foods containing excessive amounts of fat, cholesterol, sugar, and sodium.

Keywords that could show or suggest medical benefits such as treatment, prevention, diagnosis,

and cure are banned in FFC labeling. Furthermore, FFC products may not target a specific segment

of consumers suffering from a particular disease. Such products are prohibited from being

provided to minors or pregnant women and do not show any claim specific for physical changes

such as hair growth, bodybuilding, or skin whitening.

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Six key procedures are used to produce a product that has the FFC code. The first is to

determine the product's compatibility with FFC regulation within the main constraints described

above, in particular for the labeling process. Secondly, the assessment of public health by means

of safety checks, a compilation of data into databases, or a review of actual data on intake. The

third step is to build a manufacturing and product quality management and assurance program.

Hazard Analysis and Critical Control Points (HACCP) procedures or GMP systems are

recommended for manufacturers to implement. Fourthly, the creation of a reporting system for

collecting data on adverse health events. The fifth is assessing the effectiveness of the product by

conducting clinical trials or systematic literature reviews. Lastly, the manufacturer provides a

product label that meets the "Guidelines on Notification of Foods with Function Claims" standard.

The FFC category offers an easy way for small companies to reach the industry, as it does

not entail a lengthy and expensive process like FOSHU. It also does not require passing product

inspection. Unlike the FOSHU, it does give the manufacturer control over the evaluation of the

product. This new concept has caused a revolution in Japan's functional food industry. Despite the

much more recent start, the first year alone saw 172 FCC products registered. By March 2019, the

cumulative number of FFC products reached 1721, which exceeds by almost 40% the number of

FOSHU products registered in almost twenty-five years. Based on the information mentioned

above, it is predicted that the FOSHU system will decrease drastically over the coming years due

to the high cost and lengthy inspection procedures, and most manufacturers will then implement

the FFC system, making it the main system in this area. The chart below shows the development

of the FFC regulated products in comparison with the FOSHU regulated products, in terms of

accumulative number of products authorized.

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Figure 4 | Accumulative number of FOSHU and FFC authorized products in Japan (Source: CAA, MHLW)

2.3.4. Japanese Local Government Regulation System

Japanese local governments, in addition to the national systems, can certify the

functionality of food based on scientific merits. A symbolic example of this is the Hokkaido

Functional Food Labeling Program (Healthy DO), the first local government accreditation

program in Japan. Healthy DO was introduced in 2013, two years before Food with Function

Claims Framework (FFC) was introduced. Healthy-DO's goal is to promote food-related industries

in Hokkaido by growing the value of food and providing appropriate information in response to

customer needs. A product that meets the three following conditions is eligible for Healthy DO

labeling. The first condition that it uses Hokkaido functional materials and main ingredients. The

second that it is a processed food product made in Hokkaido. The third that it has released a peer-

reviewed paper with the findings of a human intervention test for the ingredients of the products.

As of March 2020, 110 items were accredited as Healthy-DO Items.

0200400600800

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A distinction between FFC and Healthy-DO products is that FFC products only need to be

reported to the CAA Consumers Affairs Department, while Healthy-DO products need to go

through a Hokkaido Local Government certification process. With functional materials, it may be

suggested that it is suitable for preserving and promoting safety, but these indications of efficacy

are not permitted in Healthy-DO, and only an indication of empirical evidence for functional

content is permitted. Studies of human intervention are needed on both systems. FFC products

include a clinical study that uses each final product. A peer-reviewed paper describing a human

intervention study would be required for Healthy-DO products, but it is not mandatory to perform

a human intervention study for each final product. In addition, foods that contribute to high levels

of blood sugar such as confectionery are not FFC approved, while Healthy-DO products do apply,

allowing for the certification of confectionery and luxury goods. If the product meets the criteria

for both systems, the Healthy-DO and FFC labels that appear on the same product. Based on the

comparison and the information mentioned above, it is highly anticipated that the local Healthy-

DO program will help small business goods to easily obtain certification, opening doors to growth

in this sector.

The table below summarizes all the functional food related regulations in Japan namely;

FOSHU, FNFC, FFC, and local systems in terms of complexity, history, labelling regulations,

characteristics, inspection regulations, regulatory authority and other aspects.

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Table 6 | Summarized description for functional food categories in Japan

Category Characteristics

FOSHU | Food for

Specified Health Use

• The main regulation that governs functional food in Japan since 1991

• Can be labeled with specific effect (ex. cholesterol reduction)

• The process is lengthy, complicated and requires a substantial investment

• Every product must be examined individually by several governmental entities

• High barriers to entry which is difficult for startups or small business to apply

• Product samples must be inspected, and the effect must be proven

FNFC | Food with

Nutrient Function

Claims

• The second main regulation that governs functional food in Japan since 2001

• Specifies all food that is labeled with the nutrient function claims

• Utilized as a supplement for necessary daily intakes of nutrients (ex. vitamins)

• FNFC Nutrients must be fundamental for human activities

• Ingredients efficacy must be scientifically proven and well-studied

• Specified allowed ingredients (13 vitamins, six minerals, n-3 fatty acids)

• Must be labeled with the authorized dosage and warnings

• Doesn't require permissions of the producers guarantee that it meets standards

FFC | Food with

Function Claims

• The latest regulation issued by CAA in 2015 to govern functional food

• Allows business to label the food based on a notification system to CAA

• CAA must be notified by product details 60 days before the launch date

• Products must meet national requirements and conform with safety standards

• Products must have evidence for efficacy by clinical trials or systematic

reviews

• Products must be labeled with the main ingredients, daily usage, and warnings

• Products must not target specific segment who suffer from a certain disease

• It provides an affordable way for startups to enter the market because it doesn't

require lengthy and expensive procedures, unlike FOSHU.

Japanese Local

Government

Regulation System

• The first example for the local system is Healthy-Do, which is issued by the

Hokkaido local government in 2013.

• The products must have functional materials and manufactured in Hokkaido

• Must have a peer-reviewed article with results from a human intervention

study for the product's ingredients.

• Allows confectionery and luxury goods to be certified.

• The items can have Healthy-Do seal along with FFC if it meets requirements

• Number of products are 110 items (as of March 2020)

• Allows startups and local manufacturers to enter the industry

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2.4. Functional Food Global Regulations

2.4.1. Regulators

Functional foods are governed in each country according to the rules and guidelines defined

by the regulator. The main regulator for functional foods in the EU is the European Commission

(EC), which has started to adopt food supplement regulations according to the European

Parliament and Council Directive 2002/46 / EC of 10 June 2002. In the United States, the Federal

Food and Drug Administration (FDA) is the regulator. The FDA started the functional food

labeling scheme in 1991, and also issued the 1994 Dietary Supplement Health and Education Act

(DSHEA). In Korea, the regulator is the Ministry of Food and Drug Safety (MFDS), which in May

2004 elaborated on the Health Function Food Act. The Taiwan Food and Drug Administration

(TFDA) exists in Taiwan. In China, the responsible entity is the Chinese Food and Drug

Administration, which issued the first functional food law in 1996, also finalized detailed rules for

the filing of health food applications, and in May 2017 began a new official process to accept the

application for health food filing. In Singapore, the Health Sciences Authority (HAS) is the

regulator. In Japan, the responsible entity is CAA.

2.4.2. Product Categorization

There is a major gap between the rules and regulations relating to functional food and

pharmaceutical development. As well as the validation and authorization process, the development

process is different. All the above-mentioned countries have created specific laws, regulations, and

standards for functional or health foods that are independent of pharmaceutical laws and

regulations. Countries consider functional foods as a particular category of food items, even though

there is no separate regulatory structure.

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2.4.3. Shape Description

Functional food products can come in various forms, such as capsules or tablets. Each has

different characteristics of dissolution and different dosage types. When a capsule normally

contains powder or jelly, the substance is formed in solid shape by tablets. In terms of efficacy,

capsule content tends to enter the bloodstream much faster than tablet ingredients, especially if

tablets are covered with substances that slow bloodstream delivery. Capsules also appear to have

a shorter shelf life than tablets, thus making tablets a better long-term storage choice. In terms of

functional food packaging, it is important to understand the labeling regulations. The product type

(tablets, capsules) needs to be specified in the EU, Singapore, and the USA. Such a description in

Korea, Japan, and Taiwan is not required, though. In China, the product's shape is often displayed

on all the products, but not always. If a manufacturer produces functional food export packages to

the EU, Singapore, or the US, that manufacturer should meet the labeling requirements by

displaying the product's shape.

2.4.4. Product Purpose

There is a strong distinction between controlling healthy foods and pharmaceutical

products for use purposes and details relating to the market. Pharmaceuticals are often sold as

remedies or therapies for serious illnesses. Functional foods, on the other hand, tend to be marketed

as additives or as sources of boosted nutrients. Efficient food marketing strategies and labels can

only communicate the message of being dietary supplements or improved vitamins and nutrients

in the countries we've compared (EU, USA, Korea, Taiwan China, Singapore, and Japan). These

may not be marketed as products that treat any medical condition.

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2.4.5. Positive List

A common approach by regulatory authorities to ensure the safety of functional food

ingredients is the creation of a “positive list.” Regulations call for clear identification of

permissible ingredients, and regulators provide a positive list containing the names of the vitamins,

minerals, and other substances approved for use in functional foods, along with their permissible

sources. Some countries also have a negative list containing possible ingredients not allowed in a

functional food product (FSAI, 2007). In the countries we've compared, we found that China, the

EU, Japan, Korea, Singapore, and Taiwan provide the permitted components with a specific

positive list, while the US does not provide such a list. While the existence of the positive list and

the negative list may create some limitations on the ingredients that can be used by manufacturers,

they provide clear support for manufacturers to gain certification or validation for their products

on global markets.

2.4.6. GMP System – Good Manufacturing Practice

Many manufacturers of functional food products prefer to follow the Good Manufacturing

Practice (GMP) framework to ensure the goods are produced with a high degree of health and

quality. The program ensures the manufacturing process meets the regulations necessary. The

GMP requirement is not limited to manufacturers alone; it may extend to include the packaging

and labeling facilities, as well as the distribution centers and storage facilities. This program offers

the customer the assurance that the product has the highest standard of protection, honesty, power,

purity, consistency, and composition (SISPQC). The GMP program is not limited to produced

goods only. It focuses on the entire production environment, covering all the premises required for

product marketing, the quality assurance of the personnel involved in creating the products, and

the various processes the manufacturer used (Bagchi, 2008). The GMP method is distinct from

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country to country. We found that the United States, Korea, Taiwan, and China have dedicated

GMP systems for producing functional food products. According to the general food legislation,

the EU has HACCP and food GMP. According to the Food Sanitation Act, Japan has the HACCP

requirement, and GMP is for supplement type foods such as tablets and capsules. Singapore does

not require a particular GMP for functional foods, however there are several GMP systems used

in the country in general.

2.5. Functional Food Regulations Conclusion

The global market size of functional food is constantly increasing, particularly with the

increase of the elderly populations and the increase in life expectancy. Consumers in several

markets around the world began to learn more about the benefits of functional foods, fueled by a

rise in disposable income. The Asia-Pacific market is the world's leading regional market for

functional foods generating nearly 40 percent of global revenues in 2017, and a compound annual

growth of nearly 8 percent over the coming six years is also highly expected.

It is highly expected that the FFC to become Japan's key regulatory mechanism, in which

companies can sell their goods while planning to obtain the FOSHU licenses. The study has shown,

after observing the rules and regulations in different countries, that compliance with various

certifications and disclosure of product details are essential in the United States. The

implementation of these steps involves a very high expense that may present problems for Japanese

goods in American markets. There are less constraints on the Singaporean markets, and it is

considered an attractive economy and marketplace for the Japanese products.

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China is seen as a vast and rising market. Due to many health risks and the rise of non-

communicable diseases such as obesity, the Chinese market is turning towards functional foods.

China has a large number of senior citizens too. The reasons set out above makes China an

attractive market for Japanese goods. It is strongly recommended to start promoting the products

listed in each country's positive list such as the list of China, since that it will have far lower

development costs, and to target countries with less entry barriers. We also suggest further

negotiations with each country's approved agencies to promote and accelerate product promotion

with a view to preventing uncertainties.

Another way to reach a crucial and diverse market like the United States is by marketing

the practical food commodity to targets. The American functional food market is rising by 10

percent annually, allowing the main ingredients to be constantly supplied. The global market for

functional food ingredients is close to USD 67 billion in 2017, and an annual compound growth

of 6.7 per cent is expected over the coming years (Data Bridge, 2017).

Small start-up companies that are shaping and revolutionizing the food's future might also

use the findings. The research provides the startups with important knowledge by partnering with

manufacturers in this area to create new products or solutions for the international markets.

The table below summarizes the findings of the global functional food regulations

comparison, which compares the regulations in Japan, US, EU, China, Korea, Taiwan and

Singapore. The table summarizes the comparison especially the points mentioned above, and it is

the product of the collaboration of several co-authors in a peer reviewed article that we have

published earlier in 2019.

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Table 7 | Summarization for the global functional food regulations (Source: Farid, et al. 2019)

Item Japan US EU China Korea Taiwan Singapore

Regulatory Agency CAA/MHLW FDA EC CFDA MFDS TFDA HSA

Category Food Food Food Food Food Food Food

Shape description (tablet, etc.)

No Yes Yes Often No No Yes

Purpose: Supplement of meals

Yes/No Yes Yes Yes Yes Yes Yes

Purposes: Treatment of diseases

No No No No No No No

Approval System (Business · Item)

In parallel No Yes Yes Yes Yes No

Safety review system for the ingredients

Depends Yes Yes Yes Yes Yes Yes

Presence of positive list Yes No Yes Yes Yes Yes Yes

GMP system by country Yes Yes Yes Yes Yes Yes No

Clinical trials of individual products

Depends No For new ingredient New Ingredient Depends Depends No

Adverse reaction reporting system

Yes Yes Yes No Yes No No

Obligated to display the category name

Yes Yes Yes Yes Recommended Yes Recommended

Obligations to display the certification mark/approval number

Depends No No Yes Recommended Yes No

Obligated to display the usage and dosage

Recommended Yes Yes Yes Yes Yes Recommended

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3. Genetically Edited Food Regulations 2

3.1. Background

After conducting the regulations review of the functional food in Japan and globally, and

identified the potential opportunities for Japan to expand abroad in this field, the study has started

to develop and cover a more innovative field which is genetically edited food. This chapter focuses

mainly on the second research question (What are the key differences in terms of genetically edited

food regulations between Japan and overseas?).

The study in this chapter aims to identify the major differences in the regulations between

Japan, the United States, and the European Union in the field of genetically edited food and

discover the potential of expanding this industry. This chapter focuses mainly on the literature

review and the secondary sources represented in the governmental regulation reports and press

releases.

3.2. Genetically Modified Food

Although there is a certain unified definition that defines genetically modified food, there

are numerous definitions that define GMOs. One of the most cited definitions for GMOs is the one

issued by the World Health Organization WHO, defining GMO food as food produced from or

using genetically modified organisms. Also, the WHO has another definition for GMOs in general

as "organisms in which genetic materials have been altered in a way that does not occur naturally".

While the United States Department of Agriculture USDA states that GMO is "An organism

produced through genetic modification", the European Union is in consensus with the same

definition as the WHO definition mentioned above.

2 This section may include an adaptation of Farid, et al., 2020

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GM foods are typically food containing genetically modified organisms (GMOs). In other

words, the DNA of the species to be used as food, is altered or modified by means of biotechnology

or without natural recombination. This method is also often referred to as "DNA recombination"

or "genetic engineering." Genetic modification technology enables the selected gene to be

transferred from certain organism to another or between non-related species.

The key justification for the production of GMO food is to provide food with a higher

nutritional level as well as a greater tolerance to bacteria and herbicides. Bacillus thuringiensis

corn or Bt-corn is one of the most common examples of genetically modified food. Bt-Corn has

been developed to contain specific proteins that can work against insects or pests. Because of its

particular characteristics, Bt-corn needs fewer pesticides and has a high degree of herbicide

resistance. Bt-corn is now commonly used in the United States and has an acceptance rate of 83%.

The use of GMOs in food has led to significant controversy. To date, the majority of the

scientific community has concluded that there is no proof of substantial threats to humans from

the use of genetically modified food. A study published in 2014 by Critical Reviews in

Biotechnology found that researchers reviewed all health studies and scientific papers published

between 2002 and 2011 on the health of GMO food; on the basis of this analysis, there is a

scientific consensus that the use of genetically engineered or genetically modified food is popular

worldwide and there is no proof of any related hazards.

In addition, a major analysis of genetically modified crops carried out by the National

Academies of Science, Engineering, and Medicine in 2016 confirmed that there are solid scientific

grounds and facts to prove the safety of genetically modified crops.

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Another research on sustainable agriculture has established a wider agreement that there

has been no adverse impact on health or the climate from the cultivation of genetically modified

foods. This was decided after 14 years of continuous cultivation of GMO crops and cumulatively

planting more than two billion acres. The report also states that the European Commission-related

research lab has concluded that there is no major difference in human health impacts between

genetically modified crops and conventionally grown crops.

3.3. Genetically Edited Food

Genetic editing is seen as one of the fairly modern developments in genome engineering.

It is significantly different from genetic modification, in which gene editing of a particular genome

directly edits genes. The gene modification method usually randomly integrates a foreign gene

into the genome to alter the characteristics of the organism. Gene editing, however, transfers the

updated gene to a specific location in the genome, which determines the ultimate outcome of the

process. Over the last few years, various types of genome editors have been used, but CRISPR-

Cas9 is considered to be the most accurate tool. The use of gene-editing technology, namely

CRISPR, in food and agriculture, presently requires comprehensive research efforts. It also has the

ability to create significant importance for both farmers and consumers by limiting any potential

risks associated with genetically modified food.

CRISPR is the abbreviation for "Clustered Regularly Interspaced Short Palindromic

Repeats". Scientists use this technique as molecular scissors in order to specifically target gene in

the genome to be edited with an extremely high degree of precision. The procedure begins when

scientists identify a specific gene in the genome that is responsible for some of the features that

need to be modified. Scientists are developing an RNA guide (short for ribonucleic acid) that

simulates the sequence of DNA that needs to be modified, as well as the Cas9 enzyme, which cuts

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the actual sequence at the desired location. After the break, scientists can add or modify different

functions, and after the change, the cell can be repaired using its enzymes. After removal of the

guide RNA and Cas9 enzyme, the DNA editing protocol is deemed complete, and alterations are

implemented in relatively close to traditional organism breeding processes.

Figure 5 | How genome editing (CRISPR) works

Taking into consideration that genome editing technology is deemed scientifically safer

than genome modification technology, Japan's regulatory authorities find that food produced by

genome editing technology is close to that produced by traditional breeding. However, an online

survey study conducted by the University of Tokyo, involving more than 38,000 respondents,

found that 43% of respondents expressed a lack of willingness to eat agricultural products

1. identify the sequence to edit

2. Create guide RNA 3. Attach RNA to enzyme Cas9

4. Allocate and match to cut 5. Cut, modify, paste DNA editing

How CRISPR works

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generated by genome editing technology while nearly 9 percent only of the respondents have

shown a clear sign of willingness to adopt the genetically edited food products in the future.

3.4. GMO and Gene-Edited Foods Regulations

Regulations for the classification and labeling of genetically modified food are perceived

to be well-formulated in contrast to the regulations regulating genetically edited food, provided

the context of the marketing of genetically modified food started since 1994. In several regions

around the world, GMO regulations are gradually being formulated to comply with the latest

guidelines on health and safety and to conform with consumer labeling requirements.

This segment summarizes the laws governing genetically modified food as opposed to

those controlling genetically edited food in three regions: Japan, Europe, and the United States.

Regulations differ by region in regard to the labeling of genetically modified food. In

particular, it can be categorized as compulsory labeling or voluntary labeling. In the voluntary

situations, the authorities shall give the producer the option of labeling a genetically modified food

product unless there are substantial variations in the composition or allergenic potential of the

traditional food product, at which point the labeling is mandatory. Compulsory or

mandatory labeling may also be divided into two main categories, the pan-labeling, and the

designated product labeling. Products must be branded in the pan-labeling category if they contain

genetically modified products that exceed a certain threshold standard set by the regulatory

authority or if the product has substantial variations from the conventional one. For the designated

products labeling, specific products identified as genetically modified by the regulatory authorities

must be classified in the genetic modification category.

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In regard to genetically edited food, the regulations are still at the stage of development

where each nation establishes effective regulations on a domestic basis, as there are no

unified global regulations in this aspect. However, the regulatory authorities are divided based

on two main legislative strategies. The first strategy is to classify genetically edited foods as

genetically modified foods, which must have strict safety regulations and detailed safety inspection

for each product individually. The other approach is to deem genetically edited food products

similar to conventional products because, in many cases, there is no significant distinction between

genetically edited products and conventionally bred products.

3.4.1. Japan's Regulations

Regarding the genetically modified products, the designated Japanese authorities have

confirmed that all crops or processed food containing certain GM materials must be labeled.

Regulations for processed food products specify that if one of the top three ingredients in the

product weight ratio contains genetically modified material or if the genetically modified

ingredients account for more than five percent of the total weight ratio of the product, they must

be labeled genetically modified. However, compulsory labeling is not necessary in the case of

genetically modified materials, which cannot be detected in specific products such as oil or sauce

products.

As discussed earlier in the introduction section, the genetically edited foods are

significantly different from the genetically modified food in terms of characteristics, development

methodology, and process. As a result, the Japanese Ministry of Health, Labor, and Welfare

(MHLW) began discussing how to control food created by genome editing technology in

September 2018. On the 27th of March 2019, after studying 691 comments received from the

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public on the subject, MHLW published its policy on the regulation of genetically edited food

products.

The MHLW designated committee of experts in this regard recommended that any food

created by genome editing technology containing transgenes should be subject to the same safety

standards as those established in the current genetically modified food regulations. If the food does

not contain transgenes, it will not be treated in the same way as the food produced by DNA

recombination technology. The Consumer Affairs Agency (CAA) is responsible for labeling and

consumer safety in Japan. At the end of 2019, the CAA announced that, apart from GMO products,

which are subject to strict labeling and safety controls, products created by genome editing

technology do not require specific labeling, and it will be treated as conventional food products.

3.4.2. EU's Regulations

Laws governing genetically modified food are considered to be the most strict labeling

regulations in the world, as all genetically modified food products in Europe must be labeled in

compliance with the 1998 European Commission ruling. In November 2003, the laws and policies

governing genetically modified food were amended to include genetically modified foods with

undetectable genetically modified DNA. The Regulations have specified that conventional food

products must have genetically modified labels if it has 0.9% or more of its ingredients consists of

genetically modified content.

On the 25th of July 2018, the Court of Justice of the European Union released press release

No 111/18 specifying that genetically edited food should be regarded as a subset of genetically

modified food because it is already based on a genetic engineering approach. Subsequently, all

food produced using genetic editing technology would have to comply with all labeling and safety

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inspection rules and regulations governing genetically modified food. This judgment was contrary

to Japanese regulations, which make a full and clear distinction between genetically modified food

and genetically edited food products in terms of the technology used and the nature of the products.

This decision was seen by European research laboratories and biotechnology experts as a

setback to advancement in food technology in Europe as it will hinder the innovation in this regard.

This decision is considered to be an obstacle to scientific progress in the region because many

scientists in different countries around the world are suggesting using gene-editing technology to

help solving the food and agriculture-related economic challenges.

3.4.3. USA Regulations

The regulation of genetically edited food in the USA is still in the process of

conceptualization. Nevertheless, numerous drafts and official meetings have been held in this

regard. On the 11th of January 2017, the FDA released a proposal named “Genome Editing in New

Plant Varieties Used for Food,” which was intended to be a primary regulatory guideline and to

gain a general opinion on the procedure of regulating genetically edited food products. The Food

and Drug Administration has described genetically edited food as a food created by genetic editing

technology that enables scientists to make specific changes at a specific location of a genome.

Gene editing can be done using a number of methodologies, including CRISPR, Zinc Finger

Nucleases (ZFNs), Transcription Activator-like Effect Nucleases (TALENs) and Oligonucleotide

Directed Mutagenesis (ODM). In addition, the Food and Drug Administration has limited

genetically modified foods by requiring them to comply with the same food safety requirements

as traditional breeding foods. Although that there are no clear regulations for the genetically edited

food products yet, however, the American Department of Agriculture USDA is currently planning

to take the approach of classifying the genome edited crops as conventional crops, since that the

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alteration caused by genome editing technology may also be conducted using the traditional

breeding methods. However, the Food and Drug Administration is taking a different approach in

terms of genetically edited livestock, as the FDA is conceptualizing the idea of regulating genome

edited livestock as strict as the pharmaceutical drug regulations.

3.5. Conclusion

Genetically modified food laws are radically different between Japan, Europe, and the

United States. Japanese and European systems abide by compulsory regulations, while the US, as

stated above, abides by voluntary regulations. Regulations governing the labeling of genetically

modified food tend to be tighter in the European Union, as all products containing genetically

modified food ingredients must be labeled, even though GMOs are not detectable in the finished

product. In addition, the regulations on genetically edited food products follow the same system

as those on genetically modified food in Europe, which has created a dilemma for biotechnology

laboratories in the region as the decision hinders innovation in the field of genetically edited food.

In addition, the European decision to label genetically edited food as genetically modified

food has created another obstacle for the food safety laboratory and inspection units, as inspectors

are now required to test if the food contains genetically modified substances; however, scientists

are still struggling to find an effective method, since genetically edited food is difficult to be

differentiated than the food produced by conventional breeding methods.

The table below shows the analysis of both genetically modified and genetically edited

food regulations. It was developed on the basis of the reports by the Food Safety Center of the

Hong Kong Government and based on the analysis of other governmental sources, such as the

United States Department of Agriculture (USDA), Food and Drug Administration (FDA), Ministry

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of Health and Welfare (MHLW) in Japan, Consumer Affairs Agency (CAA) in Japan and

European Commission (E.C.).

On the basis of the above analysis, it is concluded that the Japanese system is opening the

doors to more progress in genetically edited food products and boosting innovation in this field.

Gene editing is a ground-breaking approach to addressing many food safety and security issues

and is radically different from the genome modification approach.

Japan has many agricultural challenges, and genetically editing food can be a major step

forward in crafting potential solutions to these challenges. In Japan, the regulations governing

genetically edited food are quite attractive for biotech companies to innovate in this field. Japan's

regulations allow companies to develop their products without further inspections compared to

genetically modified food.

The main question continues to be whether Japanese consumers are able to accept

genetically edited food products because they are a new form of product that also has the term

'genetics' in their name. In the earlier part of this research, several scientific articles have been

reviewed, which showed that the GMO or any genetics related term had been linked to a number

of consumer health concerns.

Therefore, and to continue exploring the main aim of this research, the upcoming chapters

shall explore more the level of acceptance of the genetically edited food among the potential

Japanese consumers, also exploring the factors that can affect or enhance the acceptance level for

similar products.

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Table 8 | Genetically Modified and Genetically Edited Foods Regulations Comparison (Source: Farid, et al., 2020)

Comparison Aspect Japan Europe USA

GM Regulation Type Designated products labeling Pan-Labeling Voluntarily Labeling

GM Regulatory MHLW, CAA E.C. USDA, FDA

Advantages of GMO Regulations

Provides moderate notification for consumers

in case the food components contain GM ingredients higher than a

certain level

Provide clear identification for consumers regarding

the GM components

Provides explicit notification for customers with a specific allergy or

dietary need

Disadvantages of GMO Regulations

Does not meet the needs of the consumers who would like to ensure that the food does not contain any GM

materials at all

Difficult to ensure its full enforcement by the

government due to the limitation of the dedication

for GM components in many cases

Does not provide clear identification for GM

products for the customers sensitive to this matter

Gene-edited food regulation Yes No In the development stage

Gene-edited food commercialization No No Yes (Soy Oil)

How gene-edited food categorized As conventional food As genetically modified

food

In the development stage; however, USDA has a potential approach of

having gene-edited food as conventional, and animal products as genetically

modified

Gene-edited food requires safety testing

No, a voluntary notification system may

apply

Yes, require full testing as genetically modified food In the development stage.

Gene-edited food requires specific labeling No Yes, similar to GMO In the development stage.

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4. Genetically Edited Food Acceptance 3

4.1. Background

In the previous chapter, the regulations of the genetically edited food were discussed, and

a comparison between the regulations in Japan, the United States, and the European Union has

been conducted. Based on the results of the comparison, it was found that the regulations in Japan

give the manufacturers of the genetically edited food the ability to innovate, since that the

genetically edited food products shall not require any further inspection or labeling, due to the fact

that it can be very hard to differentiate it from the conventional food products. However, although

that it these regulations in Japan gives the manufacturers an opportunity to expand in this market,

the real question would be if the Japanese society is willing to accept this type of genetically edited

food in the future or not, giving into consideration that genetically modified foods have been

associated with negative image among consumers, and many consumers often think that

genetically edited food and genetically modified food are the same types, due to the fact that both

have the term of “genetics”.

Therefore, in this chapter, the study will focus further on the potential acceptance of the

genetically edited food products among Japanese consumers, and more specifically, the youth

segment. Also, the study shall explore the factors that affect the acceptance level the most.

4.2. Survey Design

In order to measure the factors affecting the acceptance of genetically edited food, the

survey was designed to adopt the methodology of structural equation modeling SEM. In this study,

several factors have been selected as constructs with an aim to measure the main construct of

3 This section may include an adaptation of Farid, et al., 2020

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willingness to purchase. Also, the study has put particular focus on the main factor, which is

knowledge, giving into consideration, the importance of science communication and knowledge

in affecting consumer behavior towards certain products or services. Also, the “attitude towards

technology” was considered a construct in this study, in order to measure how the people who

accept technology, in general, will perceive the genetically edited food products. The other three

constructs were studied as well, namely, trust, perceived benefits, and perceived risk in order to

measure how those factors affect the potential adoption of the genetically edited food products in

general. The constructs were selected based on several studies measuring the acceptance of

technology in general and biotechnology in specific. The studies have shown that perceived

benefits and trust have a positive effect on the willingness to purchase, while the perceived risk

has a negative effect on the willingness to purchase.

One of the critical challenges in this study is considered the lack of knowledge about

biotechnology in general among consumers, specifically the lack of knowledge regarding

genetically edited food. Usually, the general public cannot differentiate between genetically edited

food and genetically modified food, giving into consideration that genetically edited food is a

relatively new method, and also genetically modified food is often discussed in different media

sources. In order to tackle this challenge, and measure the effect caused by the lack of knowledge

as well as measuring the effect of science communication, the survey has been conducted two

times with intervention between them. The intervention has come in the form of a short

introductory presentation for less than 5 minutes between the two surveys, providing more

information about the genetically edited food and how it distinguished from genetically modified

food in terms of methodology and techniques. The intervention presentation has discussed the

issue of risk in terms of genetically engineered food in general, also the associated risk with natural

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food products either in the case of organic food or non-GMO products. The presentation also has

shown scientific facts about GMO products and the level of its production in the American market,

especially in the case of soybeans or corn. The presentation has ended by a slide showing real

examples of genetically edited food products in the United States and Japan, in order to raise the

awareness about the potential possibilities of utilizing gene-editing technology in the food

industry.

As mentioned above, the survey was conducted twice, both in the same session with

intervention between them, as shown in the figure below. The reason behind that, is to extract the

immediate reaction of the respondents after getting the science communication intervention. The

surveys before and after the intervention were identical, with the exact same list of questions, in

order to clearly identify the effect of science communication on raising awareness and affecting

the attitude towards genetically edited food.

Figure 6 | Data collection session design

General Introduction

5 Minutes

Survey 1

15 Minutes

Intervention

5 Minutes

Survey 2

15 Minutes

Identical survey questions

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4.3. Responses Collection

On the 24th of December 2019, the survey was conducted in the Osaka Ibaraki Campus of

the Ritsumeikan University in the City of Osaka, Japan. The survey took place at a main session

for the business administration school. The session was attended by nearly 240 participants whom

their age averaged 20 years old. Although the respondents were randomly selected in general,

however, selecting the business school students in particular to be the place of the study was

determined. The selection of the business school came due to the fact that the survey aims to study

the public perception in general, so schools related to technology, science, biotech, and life science

were generally avoided in order to remove the bias of previous knowledge and familiarity about

the topic. Therefore, the majority of the survey respondents didn’t have prior solid knowledge

about biotechnology or genetically edited food in specific. In order to avoid the awarding bias, and

maintain professional data collection standards and integrity, the study did not offer any type of

financial or non-financial award for the respondents by any level, and responding to the survey

questions was totally a voluntarily act from respondents who seek for developing the scientific

knowledge and participate in this study.

The survey respondents have participated in both surveys before and after the intervention

in the same session, where the whole process has been conducted in nearly 40 minutes, including

the answer of both surveys, attending the intervention presentation, and introduction. The

respondents have used their own electronic devices to respond instantly to the survey question.

The first survey was responded by 216 attendees, and after attending the short intervention

presentation, the second survey was responded by 207 attendees. After comparing the completed

samples and eliminate the respondents who participated in only one survey and did not participate

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in the other, the number of completed samples was consolidated into 180 complete samples who

answered both surveys completely, as shown in the figure below.

Figure 7 | Diagram explaining the number of survey respondents

4.4. Survey Demographics

As mentioned above in the data collection subsection, the survey took place in the

Ritsumeikan University, Osaka Japan, which resulted in 180 completed samples. Apart from SEM

related questions, several demographic questions were asked as well. Based on the responses

received regarding the gender of the respondents that 84 respondents were female, representing

47% of the total number of respondents, while 96 respondents were male, representing 53%.

Regarding the nationality of the respondents, the majority of the respondents were Japanese

national with 166 respondents representing 92% of the total number of the respondents, followed

by the 11 Korean nationals who presented 6% of the respondents, followed by 3 Chinese nationals

who represented nearly 2% of the respondents.

The survey also questioned the type of hometown that the respondents are originally from

in order to investigate if there is any difference in terms of technology acceptance between the

Total number of attendees 240

Survey 1 respondents

216

Survey 2 respondents

207

Survey 1 & 2 respondents

180 Survey 1 Survey 2

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respondents from rural hometown in comparison with the respondents from urban hometown. In

this regard, the majority of the respondents were from urban hometowns, with 130 respondents

representing 72% of the total completed responses, while 50 respondents have shown that they

have rural hometowns representing 28% of the survey respondents.

Also, the survey has explored further the living status of the respondents, asking them if

they are currently living alone, or with family or with friends. The majority of the respondents

have replied that they are living with their family, which are 128 respondents representing 71% of

the total respondents. In the second position came 49 respondents who have shown that they are

living alone, representing 27% of the respondents, and only three respondents have shown that

they are living with friends, representing nearly 2% of the respondents, as shown in the chart

below.

Figure 8 | Demographics of survey’s respondents

9684

166

11 3

130

50

128

49

30

20406080

100120140160180

Male

Female

Japan

Korea

China

Urban

Rural

Family

Alone

Friend

s

Number of Respondents

Gender Nationality Hometown Living with

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4.5. Theoretical Model and Literature Review

Based on the extensive literature review conducted, there is a research gap in the area of

discussing the acceptance of genetically edited food products in comparison with the genetically

modified food products. This lack of literature might be caused by the fact that genetically edited

food is a relatively new term, and there is a lack of knowledge among the public about it,

nevertheless that there are very few products in the market. Therefore, there is a difficulty in

creating studies about the acceptance of the product, and that is where the uniqueness of this study

relies on. In this study, the construct and the literature review were generated by reviewing

previous researches related to genetically modified food acceptance and the acceptance of

technology in general.

The conceptual model proposed in this research, as shown in the figure below, aims to

measure the direct and indirect impact of five different variables on the willingness to purchase

genetically edited food products. Nevertheless, several other insights could be explored regarding

the relationship between the factors and the effect of other factors such as the demographics.

The model tests the potential effect of the knowledge about biotechnology and genetically

edited food in specific, on the level of the consumers’ attitude towards genetically edited food

represented in the level of trust, perceived benefits, and perceived risks. Also, it tests a unique

factor namely attitude towards technology, testing how the consumer’s positive acceptance to

technology, in general, can affect positively the level of their awareness about the biotechnology

in general and genetically edited food in specific, also testing the effect of the positive attitude

towards technology on the trust in the biotech stakeholders. The model also tests how the level of

trust, perceived benefits, and perceived risks directly affect the willingness to purchase genetically

edited food products.

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Figure 9 | Conceptual model to be tested in this study

4.5.1. KN | Knowledge

Knowledge is one of the key factors that affect the attitude towards a certain subject. The

more knowledge the consumer has about a certain product, the more the consumer can make an

educated decision about it and take a well-studied action, which in this case, we call it attitude. A

paper published by the University of California Agriculture and National Resources has discussed

the role of knowledge in creating perception towards biotechnology-based agriculture. The paper

has stated that consumer survey results show some key findings on consumer attitudes towards

biotechnology in agriculture. Based on the survey conducted, there is no consensus among

consumers whether biotechnology-based agriculture is beneficial or not. However, there is a

limited group of consumers who strongly have a clear opposing opinion towards biotechnology in

agriculture. Although this opposing group is limited in terms of numbers, however, they create

active movements strongly opposing biotechnology. Unfortunately, this type of activists deemed

Knowledge KN

Perceived Benefits PB

Trust TR

Perceived Risks PR

Willingness to Purchase WTP

Attitude Towards Technology ATT

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to be successful in affecting public opinion. This negative effect is mainly caused by the lack of

scientific knowledge among the potential consumers and the lack of trusted information from

governmental sources or scientific sources that promotes the scientific evidence about

biotechnology safety. Although there are several academic materials describing this fact, however,

the materials published by academic sources lack the ease of access nor understanding among

public consumers. Therefore, the study has shown the importance of scientific knowledge among

consumers and how it can shape the attitude towards biotechnology-based products. Also, the

study highlighted the significant role that universities and governments can play in terms of science

communication and raising the awareness of the consumers about biotechnology. The educational

sources about this topic should be easy to obtained by the public, also written in simple language

that can be understood by the general public from different educational and social backgrounds

(James, 2004).

A study published by the Appetite journal exploring main factors that affect the attitude

and acceptability of genetically modified food products in Germany has highlighted that

knowledge is one of the key aspects that affect the attitude towards genetic modification, thus

affect the acceptability of genetic modification in an indirect way, as shown in the figure below

(Christoph et al., 2008).

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Figure 10 | Attitude model for genetically modified food (Christoph et al., 2008)

Another study published by the Journal of Risk Research has investigated the relationship

between the knowledge, acceptance, and trust of technologically based hazards. One of the main

goals of the study was to investigate how personal knowledge of certain hazards has influence and

relationship with perceived benefits, perceived risks, trust towards the topic, and acceptability in

general. The study has involved over 500 respondents. All the participants were university students

studying industrial engineering in particular. The mean of the respondents' age was nearly 22 years

old. The study has investigated several factors, such as social risks, social benefits, acceptability,

social trust, and personal knowledge. The study has measured the above-mentioned factors in

association with several perceived hazards by consumers, including food colorants, agricultural

pesticides, antibiotics, food preservatives, herbicides, chemical fertilizers, and genetic

engineering. The study has confirmed the model stating that there is a correlation between trust,

perceived risk, perceived benefits, and acceptability. The study has shown that the respondents

have a relatively high level of knowledge of environmental-related hazards with an average of 4.8

where all the other aspects are ranging from 3.3 to 5.4, especially regarding the atmospheric

Sociodemographic Characteristics Knowledge Perception of personal

health risks

Attitudes towards genetic modifications

Acceptability of genetic modification

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pollution, which has scored 5.4. In the same survey, the respondents had a low level of knowledge

of genetic engineering, which has scored an average value of 3.8. Also, different aspects related to

agriculture have scored low in the knowledge index as well, such as herbicides that scored 3.3, and

pesticides which scored 3.5. Therefore, the study has implied that genetic engineering has a low

level of knowledge among the general public in general and needs more efforts in terms of science

communication and awareness, as shown in the figure below (Bronfman et al., 2008).

Figure 11 | Level of knowledge associated with certain hazards

Therefore, and based on the above-mentioned studies, in this study, the construct of

knowledge has deemed to be essential in measuring the factors that affect the acceptance of the

genetically edited food products. Therefore, in this construct, the study has focused on

investigating the potential effect of knowledge on trust, perceived benefits, and perceived risks. In

this regard, the study analyzed the level of information the respondents had on genetically modified

food and genetically edited food, as well as whether they could distinguish between them.

5.45.1

4.4

4.03.8

3.73.6

3.63.6

3.63.5

3.3

0.0 1.0 2.0 3.0 4.0 5.0 6.0

Air pollution

Ozone layer depletionClimate change

Nuclear powerGenetic engineering

Water fluoridationFood colorants

Chemical fertilizersChemical disinfectants

Food preservativesPesticides

Herbicides

Knowledge

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Therefore, the study has explored whether the respondents understood the potential for the use of

genetic editing technology in food, as well as its impact on animals’ safety and wellbeing to gain

more knowledge of this technology. The questions asked in this construct are as following;

Table 9 | List of questions related to the Knowledge construct (Farid, et al., 2020)

Code Variable Measured (Questions)

KN1 I understand what genetically modified food is

KN2 I understand what genetically edited food is

KN3 I understand clearly the difference between genetically modified and genetically edited

KN4 I understand the potentials of utilizing gene editing technology on crops/food

KN5 I understand the potentials of utilizing gene editing technology on animals

KN6 I understand the potentials of utilizing gene editing technology on human health

KN7 I am willing to learn more about gene editing technology

4.5.2. ATT | Attitude Towards Technology

Attitude towards technology construct assumes that there are several consumers have a

positive attitude towards technology, and this attitude differ from consumer to another. One of the

most famous and well cited models in this domain is the technology adoption life cycle model or

as known as Rogers’ bell curve. This model was published back in the year 1957 by Bohlen, Beal

and Rogers from Iowa State University in the United Stated. The model aimed initially to create

further understanding to processes related to agriculture and home economics. The others have

continued their research efforts in developing a model named diffusion process (Rogers, 1957). In

a later stage one of the authors namely Everett Rogers has issued a book named “Diffusion of

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Innovations” in the year 1962 (Rogers, 1962), where he made a generalization out of the model to

be used in visualizing the technology adoption rate in general. The book was updated over the

years till it reached to its fifth edition published in the year 2003 (E.M. Rogers, 2003). The model

shows 5 levels of technology adoption, which clarify that consumer attitude towards technology

vary from a consumer to another, as well as its impact on the willingness to purchase. The

innovation adoption lifecycle clarifies that 2.5% of the consumers are considered innovators who

start adopting the products in very early stage. Followed by 13.5% of the consumers considered as

early adopters. Followed by 34% of the consumers considered as early majority. Followed by 34%

of the consumers considered as late majority. Ending with 16% of the consumers considered as

laggards as shown in the figure below.

Figure 12 | Categorization of products adopters

Innovators are enthusiastic to try new ideas, to the extent where they are almost intrigued

by their riskiness. The interest of innovators of new technologies takes them out of a small

community of peers and into more cosmopolitan than normal social ties. Early adoptions tend to

be more inclusive than innovators in the local social system. The early adopters, as opposed to the

cosmopolitan innovators, are considered localists. In most social environments, people in the early

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adoption group tend to have the highest degree of opinion leadership. Early-majority leaders will

accept new ideas well ahead of a traditional member of the social-system. They often interact with

peers but are not often found to hold positions of leadership. The late majority is a cynical crowd,

taking fresh ideas only after the traditional social network user. Their adoption can be supported

by economic necessity and an increase in social pressure. Laggards are traditionalists and the last

to take on board innovation. With almost no leadership of opinion, the laggards are local to the

point of being isolated from the other categories of adopters. (E.M. Rogers, 2003).

Several other studies have shown a clear relationship between the attitude towards

technology in general and the trust in technology. A paper published by emerald insight was

exploring how trust can fit in the technology acceptance model TAM in critical topics such as

mobile money among very financially sensitive consumers in India who live below the poverty

line. The study has conducted a survey by gathering data samples from 225 actual and potential

mobile money consumers and analyzed the results by utilizing the partial least square

methodology. The findings suggest that TAM's trust and core constructs, such as attitude towards

technology usage and perceived usefulness, contribute to the impact of mobile money acceptance

intention and increase the willingness to adopt. Although that this study aims to investigate the

willingness to acceptance of mobile money, which is not the topic of this research, however, this

study was found useful since that both mobile money and genetically edited food are considered

new technologies, and the audience often perceives both of them with risk mentality especially

that the willingness to adopt in this study was related to financial product examined in a very

financial sensitive environment among consumers below the poverty line (Chauhan, 2015).

Another study was published by the journal of computer and information systems in this

regard, exploring if the trust is important in technology adoption. The study has stated that trust

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study in the context of technology adoption is one of the initial building of trust and clarified that

a person must make a “leap of faith” when he is committed to new technology because of a lack

of complete information. This study uses institution-based trust theory to compare the features of

emerging technology with the confidence-building stance of potential players. This trustful attitude

is then correlated with the decision to implement the technology. The study model was evaluated

using policy capture. Policy capture is a simulation-based decision-making technique that enables

the researcher to experience a simulation of real decision-making. The questionnaire was provided

to nearly 180 undergraduate students. The results of this exploratory study suggest that trust is an

important component in the acceptance and adoption of technology and that this concept should

be incorporated into future technology-based research (Bahmanziari et al., 2003).

Another study also published by the journal of engineering and technology management

was investigating several factors related to increasing the acceptance of risk-related technology

such as autonomous driving. The research has found that trust is one of the main factors affecting

the attitude towards technology and the adoption rate towards new technologies as well (Kaur &

Rampersad, 2018).

Another study was published by the British Food Journal also in the year 2016 to

investigate the attitude towards GMO food. The study examined the attitudes towards GMOs that

have shown that the majority of respondents agree that science and technology are important to

human development and, in particular, to social growth and to the local economy. The study has

also found a positive correlation between attitudes towards technology in general and the belief

that genetically modified foods can boost agricultural production (López Montesinos et al., 2016).

Therefore, and based on the above-mentioned study, in this construct, we aim to explore

the relationship between the attitude towards technology and knowledge, as well as the attitude

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towards technology and trust. In this construct, it can be argued that consumers who have a positive

attitude towards technology, and in other words from the innovators or the early adopters of the

technology, will have a higher level of knowledge about biotechnology in general and might have

more knowledge about genetically edited food in specific. Also, consumers with a higher level of

positive attitude towards technology might have a higher level of trust in the biotechnology and

genetically edited food products. Therefore, the questions in the table below were formed to

investigate more the level of respondents' attitude towards technology, also the level of

understanding for technology related news, as well as the willingness to discuss and accept new

ideas.

Table 10 | List of questions related to the “Attitude Towards Technology” construct (Farid, et al., 2020)

Code Variable Measured (Questions)

ATT1 I am interested in science and technology in general

ATT2 I think that utilizing new technologies is essential for society development

ATT3 Generally, I understand science and technology news on Media (TV, Radio and Newspaper)

ATT4 I am usually interested to try new technological products such as new electronics

ATT5 I would like to purchase the electronic products once they arrive in the market

ATT6 I think that utilizing new technologies will continue to enhance Japan's economy

ATT7 I am willing to discuss new ideas even if it is against my beliefs

4.5.3. TR| Trust

Trust is a key component in the consumer behavior study. Several scientists have studied

the effect of trust on the willingness to purchase or increasing the adoption rate of certain products

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or services. More and above, scientists have made more efforts to study the factors that affect trust

and how to increase it. Moreover, despite the essence of the uncertain option situation involving

applications for biotechnology, trust emerges as a key variable that is often seen as a factor that

eases the decision-making process in the time uncertainty (Viklund, 2003). A paper published by

food quality and preference journal exploring the perceptions of risks and benefits related to GMO

food has argued that there is indeed a knowledge gap in the field of genetic engineering among

consumers. This knowledge gap was created due to the lack of trusted sources of information, and

that most information trending about this topic are coming from nonscientific sources (Costa-Font

& Mossialos, 2007). Therefore, more efforts needed in the area of science communication

especially related to the benefits and risks communication in order to boost the trust in genetically

engineered products.

Another study published by Moon and Balasubramanian has suggested a model examining

the public acceptance for GMOs. The study has utilized Fishbein multi-attribute model to develop

an empirical model to examine and explore the attribute of agriculture biotechnology as well as

the characteristics that encourage the public to accept utilizing biotechnology in food. The study

has shown that consumers in the UK and USA, consider that the government is the essential source

of information regarding genetic engineering technology. Therefore, trust in government

information is considered to be one of the essential drivers to enhance the awareness and

acceptance rate for biotechnology products, especially GMO food (Moon et al., 2001). This

research is examining the same factor of trusting the government in increasing the acceptance of

genetically edited food products.

Another study was conducted by a group of researchers at Colorado State University to

identify further how the general public trust different information sources about agriculture and

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biotechnology. The survey was conducted to explore the most trusted source of information among

Colorado residence, exploring different sources such as governmental sources, social media, media

reports, national government, local government, companies, universities, and other sources. The

survey has utilized four levels Likert scale survey, where if the respondents answered by 1, it

means that the information source is highly trusted, and four means the information sources are

not trusted. Based on the survey results of 403 respondents representing Colorado residence on a

proportional basis, it was found that in terms of agriculture, the residence considers universities,

research organizations, farmers, and the Colorado Department of Agriculture are the most trusted

source of information with an average mean value of 1.6. Where news reports in the media, as well

as food industry corporations, scored 2.5. Social media came at the bottom of the list of trusted

sources about agriculture with an average score of 2.9. Very similar results were obtained when

the respondents were asked about their most trusted source of information about food quality and

safety. Universities, research organizations, and the Colorado Department of Agriculture came on

the top of the most trusted sources with an average score of 1.7. Where Food industry corporations,

as well as the news reports in the media, came with very low result of 2.4, and social media has

scored the lowest score in the trusted sources with an average of 3.0. (Michael J. Martin, 2016).

Based on the above-mentioned results, the official government sources, as well as universities,

have a high level of credibility among consumers. Therefore, it would be effective if universities

and governments join together in created trusted information sources for the public educating more

about gene engineering technologies.

Also, based on the papers reviewed above, the trust construct has been created in the model

as one of the core drivers to increase the willingness to purchase genetically edited food products.

The model examines the relationship between trust and willingness to purchase and also examines

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the extent of trust the respondents have towards different information sources such as academic

researches, scientists, biotech companies, government, farmers, and media, as shown in the table

below.

Table 11 | List of questions related to the “trust” construct (Farid, et al., 2020)

Code Variable Measured (Questions)

TR1 I have trust in academic researchers working on biotechnology projects

TR2 I have trust in scientists working on gene editing technology

TR3 I have trust in biotech companies that aims to utilize gene editing technology

TR4 I have trust in the government regulations that govern food safety in Japan

TR5 I have trust that biotechnology is providing great value to the society

TR6 I have trust in the farmers in Japan who will utilize gene editing farming technique

TR7 I have trust in the news (TV, Radio, Newspaper) promoting gene editing technology in food

4.5.4. PB | Perceived Benefits

Perceived benefit refers to the perception of the positive consequences of a particular

action. In behavioral science, the term perceived benefits is also used to describe the motivations

of a person behaving and taking action or treatment. Researchers and theorists seek to quantify

positive perceptions and perceived benefits because they conclude that an individual's cognition

influences behavior in terms of acceptability, motivation, and attitudes towards certain products,

services, or actions in case if the consumer had a positive perceived benefits level (Leung, 2013).

In this regard, several related published papers were reviewed. A study published by Plos

One in 2014 has highlighted several factors related to the acceptance of genetically modified food.

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The purpose of this paper is to assess the behavior of Malaysian stakeholders towards genetically

modified (GM) salmon and to identify factors that affect their acceptance of GM salmon using the

structural equation modeling methodology. A survey was conducted on over 400 participants from

different stakeholder groups in the Klang Valley region of Malaysia. The public attitude towards

GM salmon was assessed using seven-point Likert scales using self-developed questionnaires. The

results of this study have reinforced the complexity of public attitudes towards GM salmon and

should be seen as a multi-faceted process. Relevant application-linked expectations of the religious

acceptability of GM salmon followed by perceived risks and benefits, familiarity, and the general

potential of modern biotechnology are the most important direct predictors for encouraging GM

salmon. The study has highlighted the importance of perceived benefits by the consumers in order

to enhance the attitude towards genetically modified food, thus increasing the willingness to

purchase and willingness to adopt genetically engineered food in general (Amin et al., 2014).

One of the most well-cited studies in this field is a study by Bredahl examining consumer

attitudes and purchase intentions towards GM food products. The paper presents the findings of a

survey conducted in Denmark, Germany, Italy, and the United Kingdom to explore the growth of

consumer attitudes towards genetic modification and buying decisions on genetically modified

yogurt and beer in food production. In total, more than 2,000 customers were interviewed in the

four countries. The study has examined several factors that affect the attitude towards GM food,

and it was found that perceived benefits and perceived risks have a significant direct effect on the

attitude to GM food, especially in the case of the perceived risk that had a strong positive effect

on the attitude towards GM food as shown in the figure below (Bredahl, 2001).

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Figure 13 | Estimated attitude model towards GM food (Dane mark, Germany, UK) (Bredahl, 2001)

Therefore, and based on the studies mentioned above, the perceived benefits construct was

added to the research model due to its importance in several related studies to genetically modified

food acceptance. This construct measures several factors related to how the consumers perceive

several benefits related to the consumption and adoption of genetically edited food products such

consumer health benefits, animal health benefits, benefits related to the reduction of hunger in

third countries, economic benefits for the society, and financial benefits for the consumers as

shown in the table below.

Table 12 | List of questions related to the “perceived benefits” construct (Farid, et al., 2020)

Code Variable Measured (Questions)

PB1 I think that genetically edited food shall bring more health benefits for its consumers

PB2 I think that editing animal genes is a good approach for better animal health and comfort for the animals

PB3 I think that genetically edited food will help reducing hunger in developing countries

PB4 I think that genetically edited food shall be financially suitable for the majority

PB5 Utilizing gene editing technology shall boost the farming and agriculture in Japan

PB6 Utilizing gene editing technology shall enhance the Japanese economy and society

PB7 I think even if gene editing technologies have risks, scientists will be able to fix it in the future

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4.5.5. PR | Perceived Risks

Several studies have focused on the perceived risks regarding the consumption of

genetically modified food products. One of the main studies in this regard is the study authored by

Lone Bredahl, which was mentioned in the perceived benefits construct above. The study has

examined several factors regarding the risk perception of the consumers in Europe, such as

environmental hazards and human health risks. The study has also found the perceived risks

construct has a significant negative effect on the attitude towards genetically modified food

(Bredahl, 2001).

Another study also published by the food quality and preference journal has suggested a

framework to examine the intention to purchase GM food products among food consumers. The

study has utilized several models related to this topic, namely the benefits risk analysis model and

the theory of planned behavior model to examine creating a full framework exploring the major

factors affecting the genetically modified food acceptance. The study has examined several

attributes related to the perceived risk, such as the negative effect on the environment, and whether

the consumption of GM food might cause an allergic reaction, as well as whether the consumption

of GM food can create health-related risks on the consumer. The study has found that perceived

risks have a significant negative effect on purchase intention, as shown in the figure below (Zhang

et al., 2018). As shown in the figure below, both the attitude towards GM and perceived risks

constructs had a significant effect on the purchase intentions. Also, the trust construct had a

significant effect on the perceived risk construct ask well.

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Figure 14 | Path coefficient using benefits risk analysis model (China) (Zhang et al., 2018)

Therefore, and based on the above-mentioned studies, the construct of perceived risks has

been added to the research. In this construct, the study examines the direct effect of the perceived

risks on the willingness to purchase genetically edited food products. To examine this construct,

the study has highlighted several questions where the respondents express the level of risks they

perceive towards genetically edited food such as the risk of environmental damage, health-related

risks, unknown risks in the future, and allergic reaction risks as shown in the table below.

Table 13 | List of questions related to the “perceived risks” construct (Farid, et al., 2020)

Code Variable Measured (Questions)

PR1 I think that If I eat genetically edited food, my genome might get affected

PR2 I think that if I eat genetically edited food, it will create a negative effect on my health

PR3 I think that planting genetically edited seeds is considered as a risk for the environment

PR4 I think that editing animal genes shall create risks on animal health in the future

PR5 I think that If I consume genetically edited products, it may negatively affect my descendants

PR6 I think that utilizing gene editing technology in food might create more allergies

PR7 I think of risk consequences of using gene editing technology are still unclear

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4.5.6. WTP| Willingness to Purchase

The main aim of this study in general, is to examine essential factors affecting the

willingness to purchase genetically edited food. The above-mentioned studies in the constructs

have examined similar factors related to genetically modified food. Another study published by

the food quality and preference journal has examined the attitude of Taiwanese consumers towards

genetically modified food products. The study has utilized the structural equation modeling

method in order to examine several factors related to genetically modified food acceptance by

conducting a survey with over 550 respondents in several areas in Taiwan. The study has found

that perceived risks construct has a significant negative effect on the attitude towards GM food.

Also, that perceived benefits construct has a significant positive effect on the attitude towards

genetically modified food, as shown in the figure below (Chen & Li, 2007).

Figure 15 | Path coefficient using benefits risk analysis model (Taiwan) (Chen & Li, 2007)

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Therefore, and based on the above-mentioned studies and cited models, in this construct,

the study examines how the willingness to purchase genetically edited food products is affected

by trust, perceived benefits and perceived risks. In this construct also, the study examines several

variables related to the purchase intention and consumer behavior such as health-related benefits,

related financial benefits as well as the willingness to purchase for self-consuming or for a family

member in general as shown in the table below.

Table 14 | List of questions related to the “willingness to purchase” construct (Farid, et al., 2020)

Code Variable Measured (Questions)

WTP1 I am willing to purchase genetically edited food in general

WTP2 I will buy gene-edited food if it has less fat than ordinary food

WTP3 I would buy genetically edited food if it were cheaper than ordinary food

WTP4 I will buy genetically edited food if it is grown in an environmentally friendly way

WTP5 I will buy genetically edited food if it has better nutrients than ordinary food

WTP6 I will buy genetically edited food if it provides better health benefits

WTP7 I would buy genetically edited food as a gift for family or friend

4.6. Analysis of the Data

In order to analyze the data with a high level of accuracy and data integrity, IBM SPSS

was used, along with its special edition Amos for analyzing the conceptualized model. In this

aspect, the latest edition of SPSS was utilized, namely (version 26).

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4.6.1. Validity and Reliability of the Constructs

To validate the reliability and validity of the construct, the exploratory factor analysis EFA

was utilized using the IBM SPSS, and it was implemented specifically on the survey results after

the intervention to remove the lack of knowledge bias and maintain data integrity. While

conducting the factor extraction process, the maximum likelihood method was utilized in order to

maintain the highest level of data compatibility when building the model using IBM AMOS, since

that Amos uses the same method in model building. During the factor extraction process, the

number of factors was set as six, and the maximum iterations for convergence variable was set to

25. To identify the correlated factors, the analysis has used the rotation method of Promax,

combined with the Kaiser normalization method. For ensuring a high effect of the variables on the

main constructs, all the variables with a small coefficient below 0.3 were surpassed.

Several rounds have been conducted of the EFA, and based on the parameters mentioned

above of surpasses coefficients below 0.3 or the variables that got loaded into multiple constructs

in the analysis process, ten variables out of the 42 total variables were deselected from the model,

namely; the seventh variable of the “knowledge”; the first, third, fourth, fifth and seventh variables

of the “attitude towards technology; the third, six, and seventh variables of the “trust”, as well as

the seventh variable of the “willingness to purchase”. This process has resulted an increase in the

overall model fit after focusing the analysis on 32 variables compared with the full 42 variables

listed in the main SEM survey, as shown in the EFA analysis in the table below.

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Table 15 | Exploratory Factor Analysis

Factor 1 Factor 2 Factor 3 Factor 4 Factor 5 Factor 6

KN1 0.789

KN2 0.947

KN3 0.826

KN4 0.804

KN5 0.737

KN6 0.488

ATT2 0.801

ATT6 0.597

TR1 0.815

TR2 0.844

TR4 0.408

TR5 0.378

PB1 0.508

PB2 0.77

PB3 0.678

PB4 0.526

PB5 0.795

PB6 0.465

PB7 0.529

PR1 0.594

PR2 0.837

PR3 0.781

PR4 0.752

PR5 0.802

PR6 0.684

PR7 0.448

WTP1 0.67

WTP2 0.858

WTP3 0.862

WTP4 0.785

WTP5 0.878

WTP6 0.726

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In the process of sampling adequacy measuring, Kaiser-Meyer-Olkain (KMO) test was

conducted using the SPSS software. The KMO test aims to create an accurate measure of the level

of suitability of the data to the factor analysis. KMO measures each variable included in the model,

as well as the completed model for sampling adequacy. The results of the KMO are ranged from

zero to one, where the results close to one refers to a higher level of sampling adequacy, and results

close to zero refers to a lower level of sampling adequacy. Several previous studies about the KMO

method have indicated that the KMO scores with a value ranging from 0.8 to 1, reflects that the

sampling process was adequate, where the KMO scores ranging from 0.6 to 0.8 are considered to

be borderline accepted, and finally, the scores less than 0.6 are reflecting the inadequacy of the

sampling process. Where the KMO values, which are more close to zero, indicate that there is a

large level of partial correlations in comparison with the sum of correlations, which means that it

may create a challenge in conducting the factor analysis. In the original paper crafting the KMO

test by Kaiser, six levels of KMO results were established, as shown in the table below (Revelle,

2016).

Table 16 | Kaiser-Meyer-Olkin KMO test, results guideline

KMO Score Min. KMO Score Max. Indication

0.90 1.00 Marvelous

0.80 0.89 Meritorious

0.70 0.79 Middling

0.60 0.69 Mediocre

0.50 0.59 Miserable

0.00 0.49 Unacceptable

Another test also used for ensuring that the sample is suitable for the factor analysis is the

Bartlett’s test. Bartlett test was introduced in the year of 1951 to test the sample sphericity. It

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examines if the matrix has significant differentiation compared to the identity matrix or not. It also

tests the correlations between the variables in order to provide estimated probability statistically,

showing if the matrix has a correlation among some of the variably with a significant level. The

test returns P-value to indicate the significance level. In case if the P-value returned for a sample

is less than 0.05, it indicates that the data is suitable to be used in the factor analysis process.

Regarding the first test of the Kaiser-Meyer-Olkain, which was conducted using SPSS

version 26, the test has resulted in a KMO value of 0.904, which indicates that the sample is

“marvelous” according to KMO guideline, and the sample has a very high level of sampling

adequacy. Regarding the second test, namely Bartlett’s test of sphericity, the P-value resulted in a

value below 0.001, which indicates a high level of significance. Therefore, the data were deemed

suitable for factor analysis, as shown in the table below.

Table 17 | KMO and Bartlett’s Test Results

Test Measure Value

Kaiser Meyer Olkain KMO Measure of sampling adequacy 0.904

Bartlett’s test of sphericity

Chi-Square 3805.085

Degree of freedom 496

Significance 0.000*

* indicates p-value less than 0.001 (high level of significance)

In order to ensure the study and analysis reliability, Cronbach’s alpha was calculated for

all the items tested. After calculating the Cronbach alpha using the reliability calculation function

in SPSS, the values were all found to exceed the 0.7, which is the recommended value for Cronbach

alpha reliability analysis, as shown in the table below. The Cronbach alpha results were calculated

as 0.902 for the knowledge construct with six items included, 0.702 for the attitude towards

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technology construct with two items included, 0.823 for the trust construct with four items

included, 0.870 for the perceived benefits construct with seven items included, 0.877 for the

perceived risks with seven items included, and lastly with the highest Cronbach alpha value comes

the willingness to purchase construct with a value of 0.933 with six items included. Based on the

results mentioned, the validity and reliability of the model were confirmed.

Table 18 | Reliability Values of Model’s Constructs

Construct Cronbach’s Alpha Mean Variance Standard

Deviation Number of

Items

KN 0.902 20.31 19.959 4.467 6

ATT 0.702 7.45 2.092 1.447 2

TR 0.823 13.29 7.771 2.788 4

PB 0.870 23.99 22.76 4.771 7

PR 0.877 23.11 19.574 4.424 7

WTP 0.933 19.61 24.898 4.99 6

4.7. Model Testing

After testing all the aspects related to the validity, reliability, and fitness of the model was

analyzed further to investigate how knowledge affects trust, perceived benefits, perceived risks;

also how the attitude towards technology affects knowledge and trust; as well as how the

willingness to purchase is affected by trust, perceived benefits, perceived risks. By measuring all

the P-value for all the paths measured, it was found that all the paths have a high level of

significance in the survey before the intervention, except two paths representing the effect of

knowledge on trust which had a p-value of 0.232, and the effect of attitude towards technology on

knowledge, which had a p-value of 0.383, except that, all the paths had a p-value less than 0.05

which deemed as acceptable and significant. Regarding the survey after the intervention, all the

paths have deemed sufficient, since that all the p-values have resulted less than 0.05, which shows

a high level of significance, and also demonstrates that all the paths in the final model are

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confirmed, as shown in the two tables below representing the model analysis in both surveys before

and after the intervention.

Another way also to assess the significance is the critical ratio (C.R.). The critical ratio is

resulted by dividing an estimate on the standard error (S.E.). This type of test is often also named

by the Wald test in several statistical packages. In order to get an indication of two sides'

significance with 0.05 level, C.R. should be more than 1.96 or less than -1.96. As shown in the

tables below, all the paths have shown C.R. level of more than 1.96 or less than -1.96 in the case

of perceived risk on willingness to purchase; however two paths couldn't be confirmed under the

above-mentioned conditions namely knowledge on trust which scored 1.19, and attitude towards

technology on knowledge, which scored 0.872. The two unconfirmed paths in the C.R. test, are

the same two paths mentioned above in the p-value test part, which reflects the accuracy of the

results. Regarding the survey after the intervention, all the paths are deemed significant since they

fall outside the range of -1.96 to 1.96. Therefore, all the paths are deemed valid.

Table 19 | Model’s estimated regression weights (before intervention)

Estimate S.E. C.R. P-value Result

KN ➔ TR 0.114 0.063 1.196 0.232 ** Not Supported

KN ➔ PB 0.563 0.086 4.829 0.000 * Supported

KN ➔ PR 0.301 0.073 3.288 0.001 Supported

ATT ➔ KN 0.084 0.115 0.872 0.383 ** Not Supported

ATT ➔ TR 0.438 0.096 3.601 0.000 * Supported

TR ➔ WTP 0.479 0.145 4.555 0.000 * Supported

PB ➔ WTP 0.399 0.114 4.287 0.000 * Supported

PR ➔ WTP -0.319 0.095 -3.818 0.000 * Supported

* indicates p-value less than 0.001 (high level of significance) ** indicates p-value higher than 0.05 (not significant)

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Table 20 | Model’s estimated regression weights (after intervention)

Estimate S.E. C.R. P-value Result

KN ➔ TR 0.388 0.119 2.907 0.004 Supported

KN ➔ PB 0.773 0.101 7.632 0.000 * Supported

KN ➔ PR 0.369 0.076 4.06 0.000 * Supported

ATT ➔ KN 0.701 0.128 6.144 0.000 * Supported

ATT ➔ TR 0.331 0.143 2.319 0.02 Supported

TR ➔ WTP 0.527 0.108 6.141 0.000 * Supported

PB ➔ WTP 0.437 0.095 5.134 0.000 * Supported

PR ➔ WTP -0.194 0.085 -3.042 0.002 Supported

* indicates p-value less than 0.001 (high level of significance)

4.8. Initial analysis for model’s constructs

To further analyze the full model created after the intervention, the factor analysis data

were reviewed for each construct. Overall, the constructs vary in terms of the number of variables.

However, all of the constructs contain two variables or more as the minimum value. All the

standardized loadings for all the variables in all constructs have exceeded the minimum value of

0.40 stated by Lewis and Byrd in the year 2003. The minimum value of the loadings can be found

in the trust construct with a value of 0.51 for the fourth variable. However, this value is deemed

acceptable, as explained earlier.

The first construct in this analysis is the “knowledge” construct which has the abbreviation

of “KN”. This construct contains six variables and aims to measure different points related to

knowledge about biotechnology and genetically edited food in specific. All the standardized

loading variables are considered to be high, since that all the values exceed 0.70 except variable

KN1 with a value of 0.68 which aims to verify the knowledge of genetically modified food, and

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the variable KN6 with a value of 0.62, which aims to verify the knowledge about the potential

positive effect of gene editing on human health. Both values are considered to be accepted, and

above all, the acceptable values stated by other researches such as 0.40 and 0.50. The highest

variable in terms of estimates in this construct was KN4, with a value of 0.815, which aims to

verify the knowledge about the potential effect of genome editing on agriculture, as shown in the

table below.

Table 21 | estimated regression weights for the “knowledge” construct (after intervention)

Estimate P-Value Measure

Knowledge

KN

KN1 ➔ KN 0.683 0.000* Genetically modified food

KN2 ➔ KN 0.764 0.000* Genetically edited food

KN3 ➔ KN 0.762 0.000* Difference between genetically modified and genetically edited food

KN4 ➔ KN 0.815 0.000* Potential of genome editing in agriculture

KN5 ➔ KN 0.768 0.000* Potential of genome editing in animal health

KN6 ➔ KN 0.620 0.000* Potential of genome editing in human health

* indicates p-value less than 0.001 (high level of significance)

The second construct subject to this study is the “attitude towards technology” with an

abbreviation of “ATT”. Due to running several attempts of model analysis in order to synchronize

both models before and after the intervention, to have acceptable loading values, several variables

were eliminated from this construct, and only two variables remained, which have significant

values in both models. Although the construct has two items, however, both of the items have

scored a high level of estimate above 0.70. The ATT2 item, which aims to investigate the potential

positive effect of technology on society, has an estimate of 0.755 and ATT6 with a value of 0.716,

which aims to identify a potential positive effect of technology on Japan’s economy. Although that

the case of having two items per construct is considered to be borderline, however, it is allowed

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and proven for its efficiency, according to Yong and Pearce, in 2013, who issued a guide focusing

on factor analysis. The guide mentioned stated that a construct with two variables is considered

reliable in case if the two items are highly correlated and have standardized estimates of 0.70 or

higher, which is the case in this construct where both of the items scored 0.755 and 0.716

respectively as shown in the table below.

Table 22 | estimated regression weights “attitude towards technology” (after intervention)

Estimate P-Value Measure

Attitude Towards

Technology

ATT

ATT2 ➔ ATT 0.755 0.000* Positive effect of technologies on society development

ATT6 ➔ ATT 0.716 0.000* Positive effect of technologies on Japan’s economy

* indicates p-value less than 0.001 (high level of significance)

The third construct subject to this study is the “trust” construct with the abbreviation of

“TR”. This construct aims to measure to what extent the respondents believe and trust several

variables related to biotechnology in general and genetically edited food in specific. Although this

construct contains originally seven variables, however, three variables were eliminated based on

the results of the factor analysis, especially when synchronizing the data before and after the

intervention. All the remaining variables have a high level of correlation since that all the variables

exceed the value of 0.70, however only one variable namely TR4 that aims to evaluate the level of

trust in the governmental food safety regulations has scored an estimate of 0.518 which is deemed

acceptable as mentioned in the other constructs above. The highest variable in this construct was

TR5 that has an estimate of 0843, which aims to validate the trust in biotechnology in general and

its benefits on the society, as shown in the table below.

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Table 23 | estimated regression weights for the “trust” construct (after intervention)

Estimate P-Value Measure

Trust

TR

TR1 ➔ TR 0.741 0.000* Trust in academic researchers

TR2 ➔ TR 0.749 0.000* Trust in genome editing scientists

TR4 ➔ TR 0.518 0.000* Trust in Japan’s food safety regulations

TR5 ➔ TR 0.843 0.000* Positive effect of biotechnology in society

* indicates p-value less than 0.001 (high level of significance)

The fourth construct subject to this study is “perceived benefits,” which has the

abbreviation of “PB”. This construct has a complete set of seven variables without any elimination.

This construct aims to identify what type of benefits the consumer perceive regarding the adoption

of genetically edited food products. Four variables had high estimates of values higher than 0.7,

namely PB2, PB3, PB5, and PB6. Where two variables have scored estimates ranging from 0.60

to 0.69, namely PB1, and PB7. The variable named PB4 has scored the lowest estimate value of

0.583, which aims to identify the financial benefits of utilizing gene-editing technology in food.

However, it was deemed acceptable since that it surpassed the minimum value of 0.40.

Table 24 | estimated regression weights for the “perceived benefits” construct (after intervention)

Estimate P-Value Measure

Perceived Benefits

PB

PB1 ➔ PB 0.681 0.000* Positive effect of genetically edited food on human health

PB2 ➔ PB 0.754 0.000* Positive effect of genetically edited food on animal health and comfort

PB3 ➔ PB 0.705 0.000* Eliminate hunger in developing countries

PB4 ➔ PB 0.583 0.000* Lower food pricing and financial suitability

PB5 ➔ PB 0.700 0.000* Promote Japan’s agricultural production

PB6 ➔ PB 0.784 0.000* Enhance Japan’s economy and society

PB7 ➔ PB 0.624 0.000* Benefits are higher than the risks

* indicates p-value less than 0.001 (high level of significance)

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The fifth construct in the study is “perceived risks”, which is abbreviated by “PR”. Like

the perceived benefits construct, this construct was a complete one, with all the seven variables

stated. This construct aims to identify the several risks that the consumer perceives when adopting

genetically edited food products. All the variables had a relatively high level of estimates, where

three variables scored estimates with values higher than 0.60, namely PR1, PR6, PR7. Three other

variables have scored high estimated with values higher than 0.70, namely PR2, PR4, and PR5,

where the variable PR3 came with the highest estimate of 0.838 in this construct, as shown in the

table below.

Table 25 | estimated regression weights for the “perceived risks” construct (after intervention)

Estimate P-Value Measure

Perceived Risks

PR

PR1 ➔ PR 0.668 0.000* Risk of consumer genome affection

PR2 ➔ PR 0.754 0.000* Negative effect on human health

PR3 ➔ PR 0.838 0.000* Negative effect on environment

PR4 ➔ PR 0.783 0.000* Negative effect on animal health

PR5 ➔ PR 0.792 0.000* Potential negative effect on descendant’s health

PR6 ➔ PR 0.611 0.000* Risk of creating new allergies

PR7 ➔ PR 0.661 0.000* Risk uncertainty

* indicates p-value less than 0.001 (high level of significance)

The last and the most critical construct subject to this study is the “willingness to purchase”

construct, which is abbreviated by WTP. This construct measures the willingness to purchase

genetically edited food in general as well as the willingness to purchase with different conditions

such as better health, environment, price value, and other factors. This construct is where the model

ends since it is connected with trust, perceived benefits, and perceived risks. The construct

originally contains seven variables. However, one variable, namely WTP 7, was eliminated during

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the factor analysis to maintain a higher level of model fit and data adequacy. This construct by far

is the highest construct in terms of the estimated values for variables since that all variables have

scored above 0.8, except for one variable, namely WTP 6, that scored 0.742, which is considered

a high value as well.

Table 26 | estimated regression weights for the “willingness to purchase” construct (after intervention)

Estimate P-Value Measure

Willingness to Purchase

WTP

WTP1 ➔ WTP 0.867 0.000* Willingness to purchase in general

WTP2 ➔ WTP 0.823 0.000* Willingness to purchase conditioned with low fat ingredients

WTP3 ➔ WTP 0.828 0.000* Willingness to purchase conditioned with lower pricing values

WTP4 ➔ WTP 0.846 0.000* Willingness to purchase conditioned with environmentally sustainable agriculture

WTP5 ➔ WTP 0.861 0.000* Willingness to purchase conditioned with better nutrients levels

WTP6 ➔ WTP 0.742 0.000* Willingness to purchase conditioned with better health claims

* indicates p-value less than 0.001 (high level of significance)

As a summary of all the tested constructs, all the variables have scored a p-value of less

than 0.001, which indicates a very high level of significance. Six different constructs were

analyzed, with an original number of variables of 42 variables. However, ten variables were

eliminated, and 32 variables remained subject to this analysis. All the 32 variables have exceeded

the minimum value of 0.4, where the majority of the variables had a high level of estimates. Of

the total number of 32 variables, none of the variables have scored an estimate below 0.5, and only

two variables have scored estimates of 0.50 to 0.59. Seven variables had an estimated value of

0.60 to 0.69. The majority of the variables, specifically 15 variables, have obtained the estimated

values from 0.70 to 0.79, followed by eight variables that obtained the estimated value between

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0.80 to 0.89. Based on that analysis and as pointed earlier than more than 70% of the variables

have obtained estimate values of 0.70 or higher, which indicates the high level of correlation

between the variables in each construct.

4.9. Model’s Path Coefficient

As discussed earlier in the above subsection, the model has achieved all the significance

requirements represented in having all paths with a p-value less than 0.05, as well as having a C.R.

value outside the range of -1.96 to 1.96. Therefore, the model has deemed significant, especially

using the dataset after the intervention. Regarding the path coefficient, it was found that all paths

hold positive values which indicates a positive impact in all paths, except the path between

perceived risks and willingness to purchase, which had a negative value indicating on the negative

impact of perceived risk on the willingness to purchase genetically edited food products in general.

The model below shows the relations between different factors and how it affects the

willingness to purchase genetically edited food products. The estimates in the model below are

based on the dataset gathered before the intervention. Therefore, it shows a lack of knowledge of

the respondents regarding the topic. The model shows a non-significant effect from attitude to

technology on the knowledge construct with a value of 0.08 and a p-value of 0.383. Another

insignificant effect shown in this model is the effect of the knowledge on the trust construct with

a value of 0.11 and a p-value of 0.232. The all the remaining paths have a significant p-value of

0.001 or below. The attitude towards technology has an effect on trust with a value of 0.43. The

knowledge affects perceived benefits by 0.56, and affect perceived risks by 0.30. The willingness

to purchase is affected by the trust by the level of 0.47, and affected by perceived benefits by the

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level of 0.39, and affected by the perceived risks by the level of -0.31, as shown in the model

below.

Figure 16 | Model’s standardized estimates based on the data before the intervention

The figure below shows the standardized estimates of the model based on the data collected

after the intervention. The model below shows the relations between different factors and how it

affects the willingness to purchase genetically edited food products, and it was exactly a duplicate

of the same model used before the intervention, as well as the same survey questions. The estimates

in the model below are based on the dataset gathered after the intervention. Therefore, it shows a

higher level of knowledge about genetically edited food products in comparison with the survey

before the intervention. The model is considered a complete one since that all the paths in the

model are significant, with a p-value lower than 0.05. The model shows an effect of attitude

towards technology on knowledge by 0.70, and on trust by the level of 0.33. The model also shows

an effect of knowledge on trust by the level of 0.38, and on the perceived benefits by the level of

Knowledge KN

Perceived Benefits PB Trust TR Perceived

Risks PR

Willingness to Purchase WTP

Attitude Towards Technology ATT 0.08

0.11 0.43 0.56 0.30

0.47 0.39 - 0.31

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0.77, as well as on the perceived risks by the level of 0.36. Also, the model shows that the

willingness to purchase is affected by the trust by the level of 0.52, and by perceived benefits by

0.43, and by the perceived risks by the level of -0.19. The results of this model show the significant

difference compared to the results from the first model especially on the effect of attitude towards

technology on knowledge, as well as the effect of knowledge on trust, which are two significant

paths in the model after the intervention compared to insignificant values in the model before the

intervention.

Figure 17 | Model’s standardized estimates based on the data after the intervention

4.10. Model’s Goodness of Fit

Accepting or rejecting a certain model is considered to be a critical decision, especially for

models that have implications on policy or education (Bentler, 1990). Several scholars have

Knowledge KN

Perceived Benefits PB Trust TR Perceived

Risks PR

Willingness to Purchase WTP

Attitude Towards Technology ATT 0.70

0.38 0.33 0.77 0.36

0.52 0.43 - 0.19

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designed sets of indexes to validate the goodness of fit for the conceptual models and to verify

whether the model fits the data (Browne & Cudeck, 1992). Fit indices are mainly categorized into

two categories, namely, absolute and incremental fit. The study shall focus mainly on the absolute

fit indices due to being the most fundamental indications for the level of fitness of the data to the

theory (Hooper et al., 2007).

Table 27 | Acceptable fit rules for selected factors

Symbol Fit Index Acceptable Fit Source

χ 2 / df Relative Chi Square

< 2.00

< 2.00

< 2.00

Ullman, 2001

Schermelleh et al., 2003

Schreiber et al., 2006

SRMR Standardized Root Mean Square Residual

< 0.070

< 0.090

<0.080

Bagozzi and Yi, 2012

Hair et al., 2010

Schreiberet et al., 2006

RMSEA Root Mean Square Error of Approximation

≤ 0.070

< 0.080

≤ 0.060

Bagozzi and Yi, 2012

Hair et al., 2010

Hu and Bentler, 1999

CFI Comparative Fit Index > 0.920 Hair et al., 2010

One of the main absolute fit indices is the relative chi-square, which is also known as

normed chi-square. In order to reach the value of the relative chi-square, the calculated chi-square

index of the model is divided by the degree of freedom. This index is commonly used in structural

equation modeling studies since it has low sensitivity towards sample sizes. Several studies have

shown estimated values for the acceptance of the relative chi-square index of any value above 0

and less than 2, as shown in the table above.

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Another well-known fit index is the standardized root mean square residual or as known as

SRMR. Like the relative chi-square, SRMR is an absolute fit index as well. It shows the value of

the standardized difference when comparing the observed correlation with the predicted

correlation. The values for this index are ranging from 0 to 1, where the values closer to 0 are

considered to be more acceptable as a degree of model fit. Values below 0.9 are acceptable,

according to the study by Hair et al. in the year 2010. Also, another study by Schreiberet et al. in

the year 2006 has indicated that values below 0.08 are acceptable, as well as a study by Bagozzi

and Yi in the year 2012 who indicated that values below 0.07 are acceptable.

Another index for measuring the model fit is the root mean square error of approximation

or as known as RMSEA which currently very popular among all the papers published using the

methodology of structural equation modeling. Like the normed chi-square and SRMR, RMSEA is

an absolute measure as well, which avoids the bias of sample size. The values of RMSEA ranges

from 0 to 1, where values closer to 0 indicate better fitness level of the model. A study by Bagozzi

and Yi in the year 2012 has indicated that the acceptable value for RMSEA is equal or below

0.070, where Hair et al., in the year 2010, has indicated that the acceptable value is below 0.080.

One of the most renowned studies in this field is a study published by Hu and Bentler in the year

1999, where it indicated that fit value is equal or below 0.060, as shown in the table above.

The comparative fit index or as known as CFI, is an incremental measure for fit. It analyzes

the differences between the input data and the model subject to the hypotheses. The CFI values

are ranged from 0 to 1, where values closer to 1 indicate a better level of fitness. A study by Hair

et al. in the year 2010 has indicated that values above the 0.920 are considered to be acceptable,

as shown in the table above.

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Table 28 | Model fit index

Measure Value Acceptable Fit Source Status

χ 2 / df 1.639

< 2.00

< 2.00

< 2.00

Ullman, 2001

Schermelleh et al., 2003

Schreiber et al., 2006

Accepted

Accepted

Accepted

SRMR 0.065

< 0.070

< 0.090

<0.080

Bagozzi and Yi, 2012

Hair et al., 2010

Schreiberet et al., 2006

Accepted

Accepted

Accepted

RMSEA 0.060

≤ 0.070

< 0.080

≤ 0.060

Bagozzi and Yi, 2012

Hair et al., 2010

Hu and Bentler, 1999

Accepted

Accepted

Accepted

CFI 0.926 > 0.920 Hair et al., 2010 Accepted

By testing the model fitness value across all the measures listed above, the model has

passed all the acceptable values where it has scored 1.639 in χ 2 / df index, while the acceptable

value is below 2.0, according to Ullman, Schermelleh, and Schreiber. Regarding standardized root

mean square residual SRMR value, the model has scored 0.065, while the acceptable value below

0.070, according to Bagozzi and Yi, and below 0.080, according to Schreiberet, as well as below

0.090 according to Hair. Regarding root mean square error of approximation RMSEA, the model

has scored a value of 0.060 which is considered acceptable according to Bagozzi and Yi who stated

that the acceptable value is equal or less than 0.070, as well as to Hair who stated that the acceptable

value is below 0.080, and Hu and Bentler who stated that the acceptable value is equal to or below

0.060. Regarding the comparative fit index CFI, the model has scored 0.926, which is considered

an acceptable value according to Hair et al. in the year 2010, who stated that the acceptable value

should be higher than 0.920, as shown in the table above.

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4.11. Willingness to Adopt

In order to further verify the real effect of the knowledge and science communication on

the increase the level of the adoption of the genetically edited food product, the respondents were

asked a direct binary yes or no question asking them if they are willing to adopt the genetically

edited food products in the future. The respondents have answered the same question before the

intervention and after the intervention. By analyzing the results, it was found that in the first

survey, only 43 respondents have replied with yes, representing 24% of the total survey population,

where 137 respondents representing 76% of the survey respondents have replied with no, which

represents refusal for adoption genetically edited food product. After conducting the intervention,

which aims to increase the awareness of the respondents by the nature of genetically edited food

and the aspects differentiating it from the genetically modified food, significant differences were

found. In the second survey, the number of respondents who showed their willingness to adopt

genetically edited food and answered with yes in the survey has increased from 43 people in the

first survey to 73 people in the second survey, representing a massive increase of nearly 70% of

the acceptance level since that it has increased from 24% in the first survey to 41% in the second

survey after the intervention. Subsequently, the number of respondents who replied by no has

decreased from 137 in the first survey to 107 in the second survey, as shown in the table and figure

below.

Table 29 | Willingness to purchase binary question responses table

Yes No

Number % Number %

Before Intervention 43 24% 137 76%

After Intervention 73 41% 107 59%

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Figure 18 | Willingness to purchase binary question chart

In order to further validate the statistical significance of the differences in the values above,

SPSS was used to conduct the chi-square test. Based on the calculations, it was found that the two-

sided asymptotic significance was less than 0.001, which is an indication that the values are

significant, as shown in the table below.

Table 30 | Willingness to purchase binary question (chi-square test)

Value df Significance

Pearson Chi-Square 70.358 * 1 0.000

Number of Valid Cases 180

* The minimum expected count is 17.44.

24%

76%

Before Intervention Yes No

41%

59%

After Intervention Yes No70% increase

in acceptance rate

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Based on the values mentioned in the tables above, which has indicated a significant

difference between the acceptance rate of the genetically modified food before and after the

intervention, it can be concluded that there is a positive effect for increasing the knowledge by the

science communication on the level of acceptance of genetically edited food, and it highlights the

importance of increasing the awareness in this matter.

4.12. Effect of knowledge and science communication

In order to further identify the detailed effect of the intervention represented in the short

presentation conducted between the first and second surveys, the study has compared the mean

and level of significance between the respondents’ responses before and after the presentation.

The figures below show the box and whisker plot for each of the constructs. The values on

the left of the chart represent the responses before the intervention, while the values on the right

represent the responses after the intervention. The box and whisker plot or as known as box plot,

is considered to be a very convenient way to compare between two groups and provide a visual

representation for the data distribution.

The figure below shows the box plot for the knowledge construct where the full seven

items were assessed. Visually and before studying the data further, it is clear that the mean line of

the survey data after the intervention is higher than the mean line of the data before the

intervention, which shows the positive effect that the intervention created in terms of raising the

knowledge and awareness of biotechnology and genetically edited food in specific.

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Figure 19 | Respondents mean-line before and after intervention (Knowledge)

Discovering further the items that were affected by the intervention in the knowledge

construct, it was found that the intervention has created a significant positive effect on all the items

in the construct. Overall, the mean of the knowledge data has increased by 39% from 2.42 before

the intervention to reach 3.37 after the intervention. The most changed variable was KN3, which

its mean value has increased by 65% from 1.99 to 3.29 after the intervention. This item in specific

was the core item in the presentation, since that it investigates if the respondents understand the

difference between genetically edited food and genetically modified food or not. The answers

mentioned above show that the intervention was successful in increasing the awareness about this

part in particular. The lowest item changed based on the intervention was KN7, since that it has

changed by 8% only from 3.05 to 3.29, which investigates if the respondents became more

interested in learning more about genetically edited food. Although the change in this item was

low in terms of value, it had a significant level as well, as shown in the table below.

KN1 KN2 KN3 KN4 KN5 KN6 KN70

1

2

3

4

5

6

Before After

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Table 31 | Comparison for the intervention significance for the knowledge construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

KN1 3.03 3.52 0.94 0.91 0.48 16% 0.000 significant

KN2 2.28 3.40 1.02 0.93 1.12 49% 0.000 significant

KN3 1.99 3.29 0.98 0.94 1.29 65% 0.000 significant

KN4 2.17 3.36 1.03 0.92 1.19 55% 0.000 significant

KN5 2.17 3.43 1.05 0.87 1.26 58% 0.000 significant

KN6 2.26 3.32 1.08 0.89 1.07 47% 0.000 significant

KN7 3.05 3.29 1.02 0.97 0.24 8% 0.001 significant

Mean 2.42 3.37 1.09 0.92 0.95 39%

Moving to the second construct, which is the attitude towards technology, aims to measure

the level of interest that the respondents have towards technology in general. From the visual

representation in the box plot below, it was observed that the values of the responses after the

intervention are slightly higher than the values before the intervention. However, both values are

correlated to some extend judging by the synchronization of the mean line movement between the

two segments before and after the intervention, as shown in the figure below.

Figure 20 | Respondents mean-line before and after intervention (Attitude towards technology)

ATT1 ATT2 ATT3 ATT4 ATT5 ATT6 ATT70

1

2

3

4

5

6

Before After

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As mentioned in the description of the box plot above, in general, there is a limited positive

change in this construct when comparing the mean of all the responses for all the questions before

and after the intervention, where the mean has increased by averagely 7% from 3.22 to 3.44. The

highest item positively increased was ATT5, which measures the level of interest among the

respondents to purchase technology in the early release stage, which has increased by 13% after

the intervention. However, the intervention had a non-significant low effect on the variable ATT6,

where it has increased by only 2% from 3.63 to 3.68, with a p-value of 0.467.

Table 32 | Comparison for the intervention significance for the attitude towards technology construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

ATT1 3.00 3.26 1.03 0.97 0.26 9% 0.001 significant

ATT2 3.72 3.77 0.96 0.83 0.05 1% 0.000 significant

ATT3 2.92 3.24 0.89 0.83 0.33 11% 0.000 significant

ATT4 3.29 3.49 1.01 0.85 0.20 6% 0.010 significant

ATT5 2.80 3.17 0.92 0.96 0.37 13% 0.000 significant

ATT6 3.63 3.68 0.87 0.82 0.06 2% 0.467 non-significant

ATT7 3.16 3.46 0.90 0.89 0.29 9% 0.000 significant

Mean 3.22 3.44 0.99 0.90 0.22 7%

The third construct subject to this study is the trust construct, which aims to identify the

level of trust in several stakeholders related to genetically edited food such as scientists,

universities, research labs, government regulations, and other factors. Also like the previous

construct, the mean-line representing the data obtained after the intervention is higher than the line

created by the data before the intervention in all the points. However, the change is quite limited,

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and visually there is a correlation between the responses before and after the intervention, as shown

in the figure below.

Figure 21 | Respondents mean-line before and after intervention (Trust)

Overall, the intervention had a positive impact on increasing the trust level for different

stakeholders related to genetically edited food. The results have seen a statistically significant

increase from 3.00 to 3.22, which represents 7%. All the variables have been increased positively

and significantly except the TR7 which aims to test the trust of the respondents in the media

channels such as TV, radio or newspaper, which the increase has failed to achieve the minimum

significance level of 0.05, and resulted in a p-value of 0.178. The highest factor affected by the

intervention was TR3, which tests the trust in the biotech company and has achieved a significant

increase of 11% after the intervention in comparison with the data obtained before the intervention,

as shown in the table below.

TR1 TR2 TR3 TR4 TR5 TR6 TR70

1

2

3

4

5

6

Before After

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Table 33 | Comparison for the intervention significance for the trust construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

TR1 3.04 3.27 0.80 0.80 0.23 7% 0.001 significant

TR2 3.00 3.26 0.81 0.84 0.26 9% 0.000 significant

TR3 2.87 3.19 0.78 0.84 0.33 11% 0.000 significant

TR4 3.04 3.26 0.89 0.97 0.22 7% 0.002 significant

TR5 3.29 3.49 0.79 0.83 0.21 6% 0.003 significant

TR6 3.04 3.22 0.78 0.82 0.18 6% 0.018 significant

TR7 2.75 2.85 0.79 0.91 0.10 4% 0.178 non-significant

Mean 3.00 3.22 0.82 0.88 0.22 7%

The fourth construct in this study was the perceived benefits construct, which aims to

explore the type of benefits that the consumers perceive from adopting genetically edited food. By

visually observing the box plot below, it was found that the mean-line representing the data

gathered after the intervention is higher than the mean line created by the data obtained before the

intervention, which shows a general increase across all the variables in the perceived benefits

construct after the intervention.

Figure 22 | Respondents mean-line before and after intervention (Perceived benefits)

PB1 PB2 PB3 PB4 PB5 PB6 PB70

1

2

3

4

5

6

Before After

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By reviewing the detailed mean analysis for each variable in the perceived benefits

construct, it was found that all the variables have increased positively and in a statistically

significant way. The overall mean has increased by 15% from 2.98 to 3.43, and all the variables

have registered an increase with a significant level of p-value below 0.001, which shows a high

level of statistical significance. In general, the respondents have perceived higher values in every

aspect after the intervention, which shows the importance of science communication in increasing

the perception of the benefits among consumers. The highest variable affected by the intervention

was PB2, which has achieved an increase of 21% after the intervention since that it has scored a

mean value of 2.76 in the first survey and 3.35 in the second survey. PB2 is the variable responsible

for testing the perceived benefits of animal health in case of utilizing genome editing technology.

Where the lowest variable changed were PB3 and PB7, which changed positively and equally by

nearly 10% after the intervention.

Table 34 | Comparison for the intervention significance for the perceived benefits construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

PB1 2.79 3.32 0.98 1.00 0.53 19% 0.000 significant

PB2 2.76 3.35 0.99 0.94 0.59 21% 0.000 significant

PB3 3.27 3.59 0.99 0.91 0.32 10% 0.000 significant

PB4 2.78 3.28 0.81 0.90 0.50 18% 0.000 significant

PB5 3.02 3.46 0.91 0.89 0.44 15% 0.000 significant

PB6 3.07 3.51 0.84 0.83 0.44 14% 0.000 significant

PB7 3.18 3.49 0.95 0.89 0.31 10% 0.000 significant

Mean 2.98 3.43 0.95 0.91 0.45 15%

The fifth construct subject to this study is perceived risks, which aims to explore different

risks and hazards that the consumer perceives if adopted genetically edited food products. Based

on the visual representation in the box chart below, it was found that the mean line before and after

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the intervention are nearly identical and highly correlated, although that the mean-line after the

intervention is slightly higher than the line before the intervention.

Figure 23 | Respondents mean-line before and after intervention (Perceived risks)

By analyzing the perceived risks further, it was found that the mean after the intervention

has increased with a very limited level of only 4% since that it has increased from 3.18 to 3.30,

which indicates that the intervention did not have any significant effect on increasing or reducing

the risk perception among consumers towards genetically edited food products and its

stakeholders. Five out of the seven items had a very high p-value, which indicates non-significant

changes between the answers before and after the intervention. Only PR2 and PR6 variables have

scored a p-value below 0.05, which indicates a high level of significance. PR2 and PR6 are

variables related to human health risks and allergies creation, although that changes in those

variables were significant, it have very low values of 3% for the PR2 variable, and 6% of the PR6

variable.

PR1 PR2 PR3 PR4 PR5 PR6 PR70

1

2

3

4

5

6

Before After

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Table 35 | Comparison for the intervention significance for the perceived risks construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

PR1 3.11 3.27 0.99 0.84 0.16 5% 0.074 non-significant

PR2 3.12 3.21 0.91 0.78 0.09 3% 0.000 significant

PR3 3.16 3.21 0.92 0.84 0.06 2% 0.520 non-significant

PR4 3.33 3.38 0.98 0.79 0.05 1% 0.552 non-significant

PR5 3.15 3.27 0.97 0.80 0.12 4% 0.156 non-significant

PR6 3.06 3.24 0.93 0.88 0.19 6% 0.029 significant

PR7 3.37 3.52 0.99 0.90 0.16 5% 0.078 non-significant

Mean 3.18 3.30 0.96 0.84 0.12 4%

The last construct subject to this study is the willingness to purchase genetically edited

food products, which aims to investigate the extend where the consumer is willing to adopt

genetically edited food under certain conditions. From the visual representation of the box plot

below, it was found that the mean-line obtained from the data after the intervention, is higher than

the mean line obtained from the data before the intervention in all the aspects. It is also visually

observed that the two lines are highly correlated. It can be concluded that the intervention has

increased the willingness to purchase genetically edited food products. From the box plot below

also, it shows that the WTP1, which aims to identify the willingness to purchase genetically edited

food products in general, is experiencing substantial difference when the results before and after

the intervention were compared.

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Figure 24 | Respondents mean-line before and after intervention (Willingness to purchase)

By analyzing the changes further that happened in the mean values before and after the

intervention, it was found that in general, the mean value for the willingness to purchase has

increased from 2.94 to 3.19 representing an 8% significant increase. By analyzing further the

different variables, it was found that all the variables had a statistically significant increase except

for one factor only, namely WTP4, which aims to analyze the level acceptance for genetically

edited food if it is grown in an environmentally friendly way. The highest variable that changed

after the intervention was WTP1, which changed from 2.76 to 3.13, with a significant change

percentage of 14%, which aims to examine the willingness to purchase genetically edited food in

general. Also, specifics related to the level of significance and means comparisons are stated in the

table below to explore the most factors that were affected by the intervention.

WTP1 WTP2 WTP3 WTP4 WTP5 WTP6 WTP70

1

2

3

4

5

6

Before After

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Table 36 | Comparison for the intervention significance for the willingness to purchase construct

Item Mean (Before)

Mean (After)

StdDev (Before)

StdDev (After) Change Change% P-value Significance

WTP1 2.76 3.13 0.89 0.99 0.38 14% 0.000 significant

WTP2 2.91 3.17 1.00 0.99 0.26 9% 0.000 significant

WTP3 2.99 3.32 0.98 0.98 0.32 11% 0.000 significant

WTP4 3.13 3.21 0.93 0.98 0.08 2% 0.278 non-significant

WTP5 3.11 3.36 1.01 0.91 0.25 8% 0.002 significant

WTP6 3.26 3.43 0.91 0.90 0.17 5% 0.041 significant

WTP7 2.44 2.69 0.93 0.99 0.25 10% 0.002 significant

Mean 2.94 3.19 0.98 0.99 0.24 8%

Based on the above-mentioned tables and descriptions, it was found that the intervention

had a positive effect on all the factors subject to the study. The most affected factor was the

knowledge, where the mean for all the responses was increased by 39% after the intervention,

followed by the increase of the perceived benefits, which was increased by 15% after the

intervention, followed by the willingness to purchase which was increased by 8% after the

intervention. The results found from this part puts further emphasis on the importance of science

communication in increasing the awareness and adoption rate.

4.13. Intervention Analysis

Based on the several studies and statistical analysis conducted in this section of the study,

it is concluded that the science communication represented in the intervention performed in this

study, has a positive effect in increasing the knowledge about genetically edited food products.

Overall, the intervention has created a significant difference and an increase in the willingness to

purchase a genetically edited food product among the survey respondents.

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5. Conclusion

5.1. Research Summary and Conclusion

This research puts a special emphasis on the role of regulations and innovation policies in

solving one of the most critical challenges that face the world. Hunger and undernourishment are

global challenges, where according to 2018 statistics, 26% of the world population have suffered

from different levels of food insecurity. In Japan, there the level of food insecurity is very low in

comparison with several other Asian countries, but Japan is facing another challenge related to

food insufficiency, especially that the number of farming households has decreased by nearly 90%

in the last 50 years. With Japan's aging challenges and the need for better health solutions, Japan

has created several policies and regulations to help in solving those challenges. Although the

functional food industry has started in Japan, however, the market in Japan is growing steadily by

nearly 2% a year, and the American market is growing by 10% a year. The research has examined

several factors that can allow Japan to explore foreign markets in food-related technologies. Based

on the global challenges and the local challenges in Japan, the research focused has been emerged

to explore further the Japanese health-food regulations in comparison with global regulations.

After studying the different regulations in Japan, it was found that there are three types of national

regulation, namely; FOSHU, FNFC, and FFC, as well as local government system regulation.

Based on the study result, the research has concluded that the FFC will continue to grow to become

the main regulation type used in Japan, since that it offers a more suitable process for SMEs to

grow in this field in comparison with FOSHU. The research also has studied different regulations

around the world in this field, especially in the United States, European Union, China, Singapore,

Korea, Taiwan. After studying the regulations in different countries, it was found that the

regulations in Japan especially FFC regulations are very accommodating for the innovation in this

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field, as a result of that, more than 2,000 FFC products have been authorized in Japan in just five

years, more than 1,500 of them are in the markets already, in comparison to the FOSHU regulations

which had an accumulative number of nearly 1,100 products in the span of over 25 years. In terms

of global regulations in this part, it was found that the regulations in the United States are

challenging for foreign companies since it requires various certifications and strict process.

However, the American market is considered an interesting market for supplying ingredients. The

study has also concluded that it can be feasible for Japanese companies to explore the foreign

markets that have a positive list such as China, which has a massive market size and acceptability

for the Japanese products. The results of this part of emphasize the role of innovation policy and

regulations in driving the innovation in food-related technologies such as FFC.

After concluding the functional food part, the study has explored furthermore innovative

field in terms of food technologies, which is the genetically edited food field. Utilizing genome

editing in food can solve several challenges related to agriculture, such as weather challenges, cost

reduction, food availability, insects, as well as to provide food with a higher level of nutrients.

Thus, it can help in solving the challenges faced by several developing countries, as well as the

challenges of the developed countries represented in the lack of agricultural workers. In this part,

the study has focused on the difference between the regulations in Japan, the United States, the

European Union in this regard. It was found that the regulations in Japan are the most scientific-

based, since that it provides the producers of the genetically edited food products the ability to

produce it without any further testing or inspection, unlike GMOs. The reason behind the Japanese

regulation that it might be difficult to detect the genetically edited food products since the edited

conducted may have been done by conventional breeding as well. This policy opens the door for

innovation in the field of genetically edited food and provides the biotech companies a golden

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opportunity to grow in the Japanese market and globally as well. Also, the policy encourages

innovation and creates an opportunity for Japan to be the technology hub for genetically edited

food worldwide. The regulations of genetically edited food in the United States are still in the

development phase, and there might be a direction that USDA will take the same approach as

Japan for the crops. However, the FDA will strictly regulate animal genome editing. For the

European market, the court has issued a ruling that genetically edited food shall be considered as

a subcategory of the genetically modified food. Therefore, it must go through all the processes and

testing required for authorizing GMO products. After concluding that the regulations in Japan are

the most suitable for innovation in this field, and will open the door for more companies to

innovate, it was found that according to previous studies, the Japanese consumers may not accept

this type of regulations for the genetically edited food and demand further labeling and safety

testing. From this point, the third part of the research has emerged to test the acceptance rate of the

Japanese consumers for the genetically edited food products and the type of factors that affect the

willingness to purchase.

There is an evident lack of knowledge among the public for the genetically edited food and

the difference between it and the GMO. Therefore, a survey measuring the factors affecting the

acceptance of the youth in Japan for genetically edited food was conducted. The survey has been

conducted twice, where we have provided the survey the first time, following by short educational

presentation, then we provided the same survey again. The survey was conducted using the

structural equation modelling method where we have measured six factors, namely; Knowledge,

Attitude Towards Technology, Perceived Benefits, Perceived Risks, Trust, and the Willingness to

Purchase. Every factor was measured using seven different questions. Also, we have conducted

the second survey to measure the impact of the intervention, which is the science communication

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in enhancing the adoption rate for genetically edited food. The survey was conducted on the 24th

of December 2019, at Ritsumeikan University, Japan, among bachelor degree students studying

business and economics. The correct and complete respondents who answered both of the surveys

were 180 persons. The data were analyzed using a Windows-based IBM Statistics software and

IBM Amos. Also, reliability and validity were examined. The hypotheses that knowledge has a

direct impact on Perceived Benefits, Perceived Risks, and Trust and that the mentioned three

factors have a direct impact on Willingness to Purchase, also the Attitude Towards Technology

directly affects Trust and Knowledge was established. All the hypotheses were confirmed based

on the P-values for the paths for the model measured after the intervention based on the second

survey data. However, reviewing the first survey result, we have failed to verify the effect of

Knowledge on Trust, and The Attitude Towards Technology on Knowledge due to the lack of

significance in this test. The study has found a definite increase effect on the paths when comparing

the models before and after the intervention stating on the role of knowledge and science

communication in changing the perception and attitude towards genetically edited food, especially

in the path between Knowledge to Trust that was found significant only in the second survey. Also,

there was a final Yes or No question asking the respondents for their final willingness to purchase

for genetically edited food, and in the first survey only 23% have shown their willingness to

purchase, however in the second survey, the number had a major increase to reach 41%. This

question has shown us a sign of change in the consumer acceptance of genetically edited food after

having an introductory level knowledge about the technology and what it brings to the consumers,

which proves the high importance of the science communication in this field.

Also, at the end of this segment, the study has compared the respondent's responses for all

the variables before and after the intervention in order to identify further the validity of the effect

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of science communication in raising the awareness and adoption rate of genetically edited food.

By conducting paired t-test for all the responses, we found that there is a significant increase in the

means of all the constructs after the intervention in comparison with the means before the

intervention. The most affected construct was the knowledge construct where it was increased by

39% after the intervention, followed by perceived benefits with an increase of 15%, followed by

the willingness to purchase with an increase of 8%. The results found from this part highlights

further the importance and efficiency of science communication in enhancing the consumer

awareness and acceptance rate.

As a conclusion, the regulations of food technologies in Japan are very accommodating

and encouraging for innovation in different fields, thanks for the innovation policies stated by the

Japanese government in the past five years. However, in order to create further success in food-

related technologies, science communication should be utilized. Concrete efforts in the area of

science communication are advised to be taken by the government, universities, and industry

together by providing clear and accessible trusted source of information for the general public.

5.2. Research Significance and Implications

This research focuses on three main parts, namely; functional food regulations, genetically

edited food regulations, and genetically edited food acceptance. The significance of this research

comes in several aspects. The first aspect that this research combines several fields in food-related

technologies, especially in Japan, comparing functional food, genetically modified food, and

genetically edited food, which makes it an integrated study for several types of food technologies.

This research also considered being one of the very few researches published by a Japanese

university in English language studying in detail the difference between several regulations related

to functional food in Japan. The research also has utilized updated sources in Japan and has

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included updates in the legislation related to functional food in Japan according to the food

sanitation act's last amendment published in June 2018 as well as the latest standards from CAA.

Regarding the functional food regulations as well, the research has highlighted the local

regulations of the functional food that allows local municipalities in Japan to certify products

created in its prefecture, for example, the Healthy-Do system, which is the local system in

Hokkaido. Such local systems are usually not highlighted in similar research that focuses on the

national regulations only.

Regarding the genetically edited food regulations part, the research is considered

significant due to the fact that the term is quite updated, and there is a lack of research articles

reviewing the regulations for genetically edited food in comparison with the genetically modified

food regulations. Also, the regulations in this regard are still in the development stage, and there

is a lack of information sources discussing it. Therefore, this research highlights the differences

between the regulations of genetically edited food in Japan, the EU, and the USA. Although the

regulations in the USA still not finalized yet. However, the research has highlighted the potential

direction that the USDA and FDA might take in this regard in the near future.

One of the most unique points about this research that the research has highlighted the

factors that affect the acceptance of genetically edited food in Japan. Currently, most of the

published papers discussing consumer behavior and acceptance around the world are focusing

mainly on genetically modified food, since genetically edited food isn't fully commercialized yet.

The research has measured several factors affecting genetically edited food acceptance, such as

perceived benefits, perceived risks, and trust. With the lack of research work examining consumer

acceptance in this field, this research opens the door for more researchers to apply the same

methodology in examining several factors in other regions in Japan or worldwide.

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The significance of the research also relays in the methodology of it, while most researches

focus on obtaining the data using one survey, this research has utilized the experimental approach

of conducting two surveys with an intervention between them to measure the difference between

the two data sets before and after the intervention. Via this intervention, the research has verified

the importance of knowledge and science communication in enhancing the awareness and

acceptance of genetically edited food products, which gave the study an empirical approach in

investigating this part.

Overall, the study also has the unique approach of examining the regulations and how the

innovation policy can support high technology industries, as well as the consumer behavior

towards those industries.

Regarding the academic implications, the study can be considered as a base study to

support more researchers to start navigating the consumer acceptance and perception of the new

food technologies such as genetically edited food in Japan and globally. The study provides a

reference in this field in particular, since that most of the similar studies conducted are focusing

more on the genetically modified food field.

Regarding the policy related implications, the study has provided empirical explanation for

the importance of knowledge and science communication, to support policy makers in this field.

It also creates the validity and the demand for more science communication policies due to its

importance. Also, the study advices a collaborative framework between the government,

universities and private sector to create trusted source of information for the consumers.

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Regarding the industry implications, the study provides significant information about the

regulation comparison, which can be utilized by different companies in this field to grow locally

and globally.

5.3. Limitations and Opportunities for Future Research

Although that this research has put several spotlights on new research areas, and also has

created significant value for the scientific research as well as implications in terms of policy and

academia in general, however, the research also has some limitations that have been totally

acknowledged regarding this research. This subsection shall highlight several limitations, that can

be utilized for future enhancements, and future studies as well.

Regarding the first part of the research that aims to discover further how Japan can grow

internationally in the area of functional food. In this part, the study has highlighted clearly the

Japanese regulations, also investigated several countries' regulations to spot the strength points the

Japanese regulations have in this regard. Although the research in this part has focused mainly on

the regulations, however, more research work can be conducted in investigating further the

consumer acceptance in the foreign markets for the Japanese functional food products. Moreover,

future researches can also highlight the different importing restrictions or procedures for the

Japanese functional food products to the foreign markets and what is the level of complexity of

the procedures to register the Japanese products in the foreign markets to be traded legally among

consumers. This research has partially highlighted the procedures needed, such as labeling

requirements in different countries. However, more research work can be conducted on the

importing legislation itself. Also, future researches can put more emphasis on business-related

studies and statistics showing market sizes in each country, and the sales and market share of the

large enterprises in this field in each country, so we can understand further the level of competition

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in each market. Also, future studies can create comparisons between the prices of Japanese

products and other global products, giving into consideration maintaining a similar level of

ingredients in order to understand the pricing level and competitiveness of the Japanese products

globally.

Regarding the second part of the research it examined the regulations of the genetically

edited food in Japan in comparison with the regulations in the United States and the European

Union. In this part the limitation is represented in the review methodology, since that in this part,

only legislation reports and press releases have been reviewed without citing comparisons from

other peer-reviewed papers, which came due to the lack of published literature reviewing the

regulations of the genetically edited food due to the uniqueness of the term. Most of the papers

reviewing the genetically edited food aim to discuss more the technicalities behind it and the

different methodologies for it such as CRISPR, TALEN or ZFN, however very few researches

focus on the regulations due to also that regulations around the world are still in the development

stage especially in the United States. Further studies also can be conducted in the future when the

legislation for genetically edited food is more clearly defined around the world. Future studies can

also focus on comparing the regulations of the genetically edited food in the countries that produce

genetically modified food such as Brazil, Argentina, India, Canada, China, Paraguay, Pakistan,

South Africa, Uruguay, and Bolivia. The reason for pointing out those countries that the countries

mentioned has cultivated more than 1 million hectares of genetically modified crops a year based

on the 2015 statistics. The countries mentioned above are supporting the cultivation of GMO crops,

and it would be a good opportunity to examine further if they are considering genetically edited

food as a conventional food or as genetically modified food.

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Regarding the third part, it focuses on the potential level of acceptance of genetically edited

food products in Japan, as well as examining the different factors that may affect the level of

acceptance. The limitation in this part that all the literature review conducted to extract the factors

subject to the study are based on reviewing genetically modified food-related paper, due to the

uniqueness of the studies examining the acceptance of genetically edited food products in

comparison with the number of studies examining the genetically modified food products.

Therefore, one of the critical issues in this research that it assumes that consumers initially perceive

genetically edited food products and genetically modified food products in the same way and that

the factors affecting the acceptance level are the same in both categories. Therefore, it is truly an

open space for research efforts to be spent more on studying further the factors affecting

genetically edited food and verify the hypotheses above.

Another limitation also regarding the survey results examining the acceptance of

genetically edited food, that consumers are not fully aware of how genetically edited food is

different from genetically modified food, and there is a misconception among consumers that both

categories are the same due to the fact that both have the term "genetically" in their titles. The

genetically modified food products are often associated with health risks in the awareness of the

consumers. Although this study has created intervention between the first and second survey to

eliminate the bias represented in the lack of knowledge regarding genetically edited food, however,

the intervention presentation took place in 5 minutes only, which was not enough to increase the

level of awareness about the difference between the two categories from a technical point of view.

However, the intervention focused more on providing simple and clear information about this

regard without a detailed explanation. Therefore, the bias represented in the lack of knowledge

might still exist in this survey results. It is highly recommended for future studies to create longer

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intervention presentation to provide more clear and detailed information about genetically edited

food in order to eliminate the lack of knowledge and test the impact of other factors such as

perceived benefits, perceived risks, and trust in a more clear way.

The most critical and the main concern related to the survey results about factors affecting

the acceptance of genetically edited food, that all the survey respondents were from Ritsumeikan

University and from a similar age group. Moreover, all the students are from the same college,

which means that they have a very similar social and educational background as well as interests.

Therefore, all the results from this survey shall be used as exploratory or introductory to examining

the factors affecting genetically edited food products acceptance further. The results came from a

very narrow sample in terms of demographics and did not represent the whole Japanese population

nationwide. Therefore, it is recommended for further studies to utilize the research work of this

study to conduct similar surveys nationwide in other cities of Japan, also expand the sample to

reach more respondents from different social backgrounds in order to verify the validity of the

model to be used to represent the whole population of Japan. Also, it is highly recommended to

conduct further studies in the future to investigate the willingness to purchase genetically edited

food products among the persons responsible for purchasing food products for the family.

Although several limitations regarding the research conducted in this study have been

acknowledged, the study is considered a pioneer in the studied fields, especially the part related to

genetically edited food acceptance in Japan. Therefore, the study is considered a gate for more

researches to implement several approaches and examine further points regarding functional food

and genetically edited food in specific as well as the role of science communication and innovation

policy in boosting innovation.

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Appendix 1: How importance the food security in the SDG

The Sustainable Development Goals SDGs are sets of global goals that were stated and

adopted by all the United Nations member countries in the year 2015. It is a global blueprint that

aims to provide a sustainable future for all countries around the world. The Sustainable

Development Goals were announced in the United Nations General Assembly with the plan to

achieve all the stated goals by the year 2030. The primary foundation of the SDGs that it tackles

all the social and most pressing challenges that the world is facing. It focusses mainly on poverty,

health, education, environmental challenges as well as other pressing issues. The total number of

goals is 17 goals, and the goals have been set to be interconnected to achieve the great purpose of

global sustainability (SDGs, 2015).

The 1st goal of the SDGs is named “no poverty,” and it aims to eliminate all the forms of

poverty everywhere in the world. Poverty poses a real challenge in achieving SDGs, since that

more than 700 million persons around the world are living in extreme poverty conditions. The 2nd

goal is named “zero hunger,” which aims to eliminate hunger around the world and provide decent

sources of food.

Figure 25 | The Sustainable development goals map

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First Goal: Zero Poverty

The first goal of the SDGs is to eliminate poverty everywhere around the world. During

the past three decades, the world has successfully reduced the number of people who live in

extreme poverty from 36% in the year 1990 to nearly 10% in the year 2015, which means that we

have over 700 million people around the world currently still living in extreme poverty conditions.

Poverty affects access to the most basic needs for daily life, such as healthcare, education, water,

and, most importantly, food. According to the United Nations studies, the majority of the sub-

Saharan Africa citizens live on less than $1.90 per day. Also, people in rural areas have more

severe conditions of poverty in comparison with the urban areas since that the average poverty rate

in rural areas is more than 17%, which more than three times the average rate in the urban areas in

this regard. Although poverty has a close connection with unemployment, however, in the year

2018, it was registered that nearly 8% of the working households around the world are living in

extreme poverty situations. Based on the statistics mentioned above, the world needs to provide

sustainable jobs and promote equality for more sustainable and inclusive economic development

in the future. Also, as we have noticed that food pricing is a critical issue that can be tackled in

order to coop with the high poverty rates, and provide decent living standards even for financially

sensitive families. There are other issues also associated with poverty, such as equality. Globally

there are 20% more women suffer from extreme poverty than men in the age 25 – 34 years old.

Also, eliminating poverty is essential for our future generations since nearly 20% of the children

around the world are suffering from poverty.

Although that the poverty situation around the world is gradually enhancing in comparison

with the year 1990, however due to the current COVID-19 crisis, the situation might get severely

worse, and might reverse the positive progress that happened in the past decades. According to the

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UN-DESA, COVID-19 will severely affect the no poverty SDG, since that the huge loss of

individual income, especially among the part-time workers, can lead to pushing a high number of

families around the world below the poverty line. The UNU-WIDER also has issued a study to

estimate the potential negative effect of the COVID-19 on the poverty rate globally with a special

focus on the per capita income. The study has calculated the several potential outcome scenarios

of global contractions with 5%, 10%, and 20% when applying the well-known poverty lines

standards of $1.9, $3.2 and $5.5 a day. The study has confirmed the above mentioned UN-DESA

assumption that COVID-19 will create an actual challenge in achieving the zero hunger SDG by

the year 2030. There is a very high probability that the poverty rate will increase for the first time

since 1990, and it may reverse a decade worth of work in the global fight against poverty. The

most extreme scenario in the study has predicted that some areas will register poverty levels similar

to the ones registered in 1990, also that the number of people suffering from poverty may increase

by 420 million people on the $1.9 line to 580 million people on the $5.5 poverty line. The study

has summarized the three different scenarios outcome in, as shown in the table below (Sumner et

al., 2020).

Table 37 | Poverty rate prediction post-COVID-19

$1.9 per day $3.2 per day $5.5 per day

Current (M Person) 759.2 1898.5 3275.8

5% Increase (M Person) 844.1 2033.8 3399.5

10% Increase (M Person) 940.8 2176.9 3524.4

20% Increase (M Person) 1178.1 2479.9 3799.3

Current (%) 10.1 25.2 43.5

5% Increase (%) 11.2 27.0 45.2

10% Increase (%) 12.5 28.9 46.8

20% Increase (%) 15.7 33.0 50.5

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As shown in the study cited above, the world is expected to have an increase in the poverty

rate after the COVID-19 crisis, which create a better urge for food-related technologies that can

help to provide enough nutrients with optimum financial value, in order to meet the expectations

and the need globally.

Second Goal: Zero Hunger

The second goal of the SDG is “Zero Hunger,” which aims to eliminate hunger and achieve

high level of food security for all as well as to improve the nutrition level worldwide. Globally,

hunger is back on the rise, and under-nutrition continues to affect millions of children. Globally,

public investment in agriculture is getting reduced, small-scale food producers and family farmers

need much more support, and increased investment in infrastructure and technology is desperately

needed for agriculture. Although the number of people suffering from hunger around the world

has been going down since 1990, however starting from 2015, the number is back again on the

rise. The number of people suffering from severe hunger has increased from 784 million in the

year 2015 to nearly 821 million in the year 2018. Nearly 70% of the undernourished citizens

worldwide are concentrated in two regions, where 277 million citizens are located in southern

Asia, and 237 million are located in sub-Saharan Africa. Overall, it is estimated that in developing

countries, nearly 13% of the total population is undernourished. This estimation is different in the

case of sub-Saharan Africa, where the percentage of undernourished people has increased from

20% in the year 2014 to more than 23% in the year 2017, making nearly 1 out of every four citizens

undenounced, which is a shocking fact. The undernourishment also can be considered the main

reason behind child mortality in several countries where 3.1 million children under five years old

die every year, representing 45% of the child mortality rate in the same areas. According to the

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latest estimates from FAO in the year 2018, nearly 22% of the total number of children under five

years old worldwide, are still suffering from undernourishment.

The level of food security is divided into three categorizations. The first one is “severe food

insecurity,” which represents the people who are suffering from extreme levels of food insecurity

and have suffered from not being able to reach any nutrition source for a complete day or more.

The second level is “moderate food insecurity,” and in this level, the people are suffering from a

medium level of food insecurity, which means that they have uncertainty on a daily basis whether

they will get food or not. Also, they might be obligated to reduce the amount of food that they

usually or need to consume in order to survive. In this category, people are eating from any source

of food they can reach to, despite its level of nutrients or hygiene. The third category is named

“food security,” which represents the people who have direct and regular access to food with

acceptable quantity and quality.

As shown in the figure below, around 700 million people worldwide representing nearly

10% of the global population are suffering from the worst level of food insecurity, where the total

number of people suffering from food insecurity in general including both severe and moderate

levels are above 2 billion person, representing 26% of the global population, which emphasize on

the importance of solving food security-related challenges.

The level of food insecurity is different from region to region, and it is highly correlated

with several other economic factors such as GDP per capita. Based on the figure below, the number

of people suffering from severe food insecurity in North America and Europe is nearly 11 million

people, who are representing slightly less than 1% of the population of this region that reached 1.1

billion people. On the other hand, we find that Africa is suffering from severe levels of food

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insecurity where the number of people suffering from that is nearly 277 million people who

represent more than 21% of the total population of 1.2 billion people.

Figure 26 | Distribution of food insecurity level in different regions (FAO, 2020)

The level of moderate food insecurity, including severe food insecurity as well, has reached

very high levels in Africa. According to the figure below, the percentage of undernourished people

in Africa has increased from 47.6 in the year 2014 to 52.5 in the year 2018, making more than half

of the African population unnourished. The level also is increasing globally since it has increased

from 23.2% in the year 2014 to 26.4 in the year 2018. The only regions that have a steady decrease

in the undernourishment rate are the northern America and Europe, where the percentage of

undernourished people has decreased from 9.6 in the year 2014 to 8.0 in the year 2018. Although

the numbers in Asia are increasing as well, however, the situation in Japan is completely different.

According to the data in 2018, nearly 0.6% are suffering from a severe level of food insecurity,

and 2.8% are suffering from moderate level including the severe level of food insecurity, where

the Average in Asia is about 7.8% for the severe levels, and 22.8% for the moderate and severe

level, which shows the strength of Japan in this field.

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Figure 27 | Food insecurity level by percentage in different regions (2014 – 2018)

Due to the COVID-19 situation, the world is expecting a wave of economic development

reduction in the upcoming few years. Scientists have created three scenarios for the GDP reduction

rate using several economic-related data. Although that the international monetary fund has created

a forecast last January that the world economy will witness a growth of 3% during this year,

however, the actual studies this April are showing contraction in the world economy by at least

3%. According to the three scenarios, it is highly expected that the number of people suffering

from undernourishment will increase by 14.4 to 80.3 million based on the economic scenarios, as

shown in the figure below (FAO, 2020).

Figure 28 | Expected increase in the number of undernourished people after COVID-19 (FAO, 2020)

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