Ensuring Global Food Safety: Exploring Global Harmonization

Ensuring Global Food Safety: Exploring Global Harmonization, Second Edition, examines the policies and practices of food law which remain top contributors to food waste. This fully revised and updated edition offers a rational and multifaceted approach to the science-based issue of "what is safe for consumption?" and how creating a globally acceptable framework of microbiological, toxicological and nutritional standards can contribute to the alleviation of hunger and food insecurity in the world. Currently, many laws and regulations are so stringent that healthy food is destroyed based on scientifically incorrect information upon which laws and regulations are based.

This book illuminates these issues, offering guidelines for moving toward a scientifically sound approach to food safety regulation that can also improve food security without putting consumers at risk.

• Presents the progress and current status of regulatory harmonization for food standards
• Provides a science-based foundation for global regulatory consensus
• Approaches challenges from a risk-benefit approach, also including safety assurance
• Includes global perspectives from governmental, academic and industry experts

• Language: English
• Publisher: Academic Press
• Release date: Feb 10, 2022
• ISBN: 9780128160121

Book preview

Ensuring Global Food Safety

Exploring Global Harmonization

Second Edition

Editor

Aleksandra Martinović

University of Donja Gorica, Centre of Excellence-FoodHub, Podgorica, Montenegro

Editor

Sangsuk Oh

Department of Food Science and Technology, Ewha Womans University, Seoul, Korea

Editor

Huub Lelieveld

Global Harmonization Initiative (GHI), Vienna, Austria

Table of Contents

Cover image

Title page

Copyright

List of contributors

Chapter 1. Introduction: Ensuring global food safety: A public health priority and a global responsibility

Chapter 2. Safety and security: the costs and benefits of traceability and transparency in the food chain

2.1. The burden of foodborne outbreaks

2.2. The food supply chain: increasing risk

2.3. Working toward traceability and transparency

2.4. The costs associated to a lack of traceability

2.5. Benefits beyond food safety

2.6. More operational efficiency

Chapter 3. Food regulation around the world

Chapter 3.1. Introduction

Chapter 3.2. International food law

Chapter 3.3. United States of America

Chapter 3.4. Canada

Chapter 3.5. The road to harmonization in Latin America

Chapter 3.6. European Union

Chapter 3.7. Turkey

Chapter 3.8. The Russian Federation

Chapter 3.9. Azerbaijan

Chapter 3.10. Australia and New Zealand

Chapter 3.11. People's Republic of China

Chapter 3.12. Republic of Korea

Chapter 3.13. Japan

Chapter 3.14. India

Chapter 3.15. Pakistan

Chapter 3.16. Eastern Africa

Chapter 3.17. Republic of South Africa

Chapter 3.18. Private food law

Chapter 3.19. Conclusions

Chapter 4. The global harmonization initiative

4.1. Introduction

4.2. Food and nutrient security

4.3. International standards

4.4. The global harmonization initiative

4.5. GHI association

4.6. GHI ambassador programme

4.7. GHI working groups

4.8. GHI library

4.9. Conclusion

Chapter 5. Food safety regulations within countries of increasing global supplier impact

5.1. Introduction

5.2. Regulations of global food suppliers by international law and standards

5.3. Regulations of global food suppliers by domestic laws

5.4. Conclusion: supplier change and global food safety regulation

Chapter 6. A simplified guide to understanding and using food safety objectives and performance objectives

6.1. Introduction

6.2. Good practices and hazard analysis critical control point

6.3. Setting public health goals—the concept of appropriate level of protection

6.4. Food safety objectives

6.5. Performance objectives

6.6. The difference between food safety objectives, performance objectives, and microbiological criteria

6.7. Responsibility for setting a food safety objective

6.8. Setting a performance objective

6.9. Responsibility for compliance with the food safety objective

6.10. Meeting the food safety objective

6.11. Not all food safety objectives are feasible

6.12. Concluding remarks

6.13. About the ICMSF

Chapter 7. Regulating emerging food trends: a case study in insects as food for humans

7.1. Introduction

7.2. Where and what?

7.3. Why eating insects?

7.4. The consumers are having a say

7.5. Regulatory aspects regarding insects for human consumption

7.6. Conclusions

Chapter 8. Some thoughts on the potential of global harmonization of antimicrobials regulation with a focus on chemical foodsafety

8.1. Introduction

8.2. Global estimates of antimicrobials in food animals—the wrong and the right trousers

8.3. The nature of antimicrobials

8.4. A precautionary tale and chloramphenicol

8.5. Risk profile of foods containing CAP—of exposure levels and toxicological models

8.6. Toward a straightforward resolution—Intended Normal Use

Chapter 9. Substantiating regular, qualified, and traditional health claims

9.1. Introduction and background

9.2. When truth and certainty must compete

9.3. Qualifying the certainty of information

9.4. RCT's and plausibility

9.5. Traditional medicinal products in the EU

9.6. Health claims based on traditional use

9.7. Basic evidential requirements

9.8. Qualifying the expert

9.9. Reliability of the expert's opinion

9.10. Principles and methodology

9.11. Degree of scrutiny

9.12. Extrapolating results obtained in diseased subjects

9.13. Plausibility

9.14. The way forward

Chapter 10. Benefits and risks of organic food

10.1. The modern food market

10.2. Why organic food?

10.3. Organic food production and market

10.4. Impact and benefits of organic food

10.5. Limitations, gaps, and future research

10.6. Conclusions

Chapter 11. Mycotoxin management: an international challenge

11.1. Introduction

11.2. Mycotoxin regulations

11.3. Harmonized regulations

11.4. Trade impact of regulations

11.5. Technical assistance

11.6. Conclusion

Chapter 12. Novel food processing technologies and regulatory hurdles

12.1. Introduction

12.2. Novel technologies

12.3. Nonthermal technologies

12.4. Thermal technologies

12.5. Legislative issues concerning novel technologies

12.6. Global harmonization concerning novel technologies

12.7. Final remarks

Chapter 13. Processing issues: acrylamide, furan, and trans fatty acids

13.1. Introduction

13.2. Acrylamide

13.3. Furan

13.4. Trans fatty acids

13.5. Conclusions

Chapter 14. Food safety and regulatory survey of food additives and other substances in human food

14.1. Introduction

Chapter 15. Food contact materials legislation: sanitary aspects

15.1. Introduction

15.2. FCMs legislation in the European Union

15.3. The Council of Europe technical recommendations on FCMs

15.4. FCMs legislation in the United States

15.5. FCMs legislation in the MERCOSUR

15.6. FCMs legislation in Japan

15.7. FCMs legislation in China

15.8. Comparison of FCMs legislations

15.9. Conclusions—harmonization, mutual recognition, and new legislations

List of acronyms

Chapter 16. Nanotechnology and food safety

16.1. Introduction

16.2. Nanotechnology and food systems

16.3. Current status of regulation of nanomaterials in food

16.4. Hurdles in evaluation and regulation of the use of nanotechnology in foods

16.5. Future developments and challenges

Chapter 17. Monosodium glutamate in foods and its biological importance

17.1. Introduction

17.2. Umami taste

17.3. Glutamate in human metabolism

17.4. Nutritional studies

17.5. Toxicological studies

17.6. Sensitivity

17.7. Health effects

17.8. Other effects

17.9. Safety evaluations

17.10. Labeling issues

17.11. Future perspective

Chapter 18. Responding to incidents of low-level chemical contamination and deliberate contamination in food

18.1. Introduction

18.2. Risk analysis

18.3. General control measures for chemicals

18.4. Case study 1

18.5. Case study 2

18.6. Case study 3

18.7. Conclusion

Chapter 19. Nutraceuticals: possible future ingredients and food safety aspects

19.1. Introduction

19.2. What are nutraceuticals?

19.3. Supposed health effects

19.4. Challenges

19.5. Regulations and safety issues

19.6. Conclusion

Chapter 20. Nutrition and bioavailability: sense and nonsense of nutrition labeling

20.1. Introduction

20.2. Scope

20.3. Methodology

20.4. Structure of the review

20.5. Overview of nutrition labeling

20.6. Nutrition labeling in different countries

20.7. Consumer understanding and use of nutrition labels

20.8. Bioavailability and nutrition label

20.9. Conclusion

20.10. Future scope

Chapter 21. The first legislation for foods with health claims in Korea

21.1. Background

21.2. Health/Functional Food Act

21.3. Health claims allowed for HFFs

21.4. Scientific substantiation of health claims for HFFs

21.5. Future directions

Chapter 22. Bioactivity, benefits, and safety of traditional and ethnic foods

22.1. Introduction

22.2. Objective

22.3. Scope

22.4. Methodology

22.5. Structure of the review

22.6. Food and chronic diseases

22.7. Biological mechanism of bioactive food compounds

22.8. Bioactive food compounds in traditional/ethnic foods

22.9. Conclusion

22.10. Future scope

Chapter 23. Water determination in food

23.1. Introduction

23.2. Water content

23.3. Water determination in dairy powders

23.4. Water content determination by near-infrared spectroscopy

23.5. Summary

Chapter 24. Global harmonization of analytical methods

24.1. Introduction

24.2. Methods for establishing the basic composition, quality, or economic value of foods

24.3. Methods for establishing the nutrient content of foods

24.4. Methods for detecting or confirming the absence of contaminants in foods

24.5. Conclusion

Chapter 25. Global harmonization of the control of microbiological risks

25.1. Introduction

25.2. Microbiological food safety management

25.3. Emerging foodborne pathogens

25.4. Microbiological criteria

25.5. Microbiological testing

25.6. Validation of microbiological methods

25.7. Harmonization of global regulations for Listeria monocytogenes in ready-to-eat foods

25.8. Conclusion

Chapter 26. Testing for food safety using human competent liver cells (HepG2): a review

26.1. Introduction

26.2. Assessment of human food safety and the current problems using existing in vitro and in vivo assays

26.3. Human HepG2 cell system

26.4. Specific features of human HepG2 cells

26.5. Validation and application of human HepG2 cells and their S9-fractions in genetic toxicology studies for assessing food safety

26.6. Conclusion

Chapter 27. Capacity building: Harmonization and achieving food safety in an era of unilateral legislation

27.1. Introduction

27.2. Capacity building

27.3. The role of multilateral agreements in achieving food safety

27.4. Unilateral food safety legislation for promoting capacity building

27.5. Conclusion

Chapter 28. Capacity building: building analytical capacity for microbial food safety

28.1. Introduction

28.2. Significance of microbial food safety

28.3. Staphylococcus and its species

28.4. Listeria monocytogenes

28.5. Bacillus cereus

28.6. Capacity building in India

Chapter 29. Role of education and training of food handlers in improving food safety and nutrition: the Indian experience

29.1. Food environment: dietary and nutrition transition as prime determinants of food behavior

Index

Copyright

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List of contributors

Fadwa Al-Taher,     VDF FutureCeuticals, Inc., Momence, IL, United States

Veslemøy Andersen,     Global Harmonization Initiative (GHI), Vienna, Austria

Alejandro Ariosti

National Institute of Industrial Technology (INTI) – Plastics Center, Buenos Aires, Argentina

Department of Food Science, Faculty of Pharmacy and Biochemistry, University of Buenos Aires (UBA), Buenos Aires, Argentina

Elisabeth J. Arundell,     The New South Wales Department of Primary Industries, Orange, NSW, Australia

Adina Alexandra Baicu,     University of Agronomic Sciences and Veterinary Medicine of Bucharest, Romania

Gustavo V. Barbosa-Cánovas,     Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, United States

Daniela Bermúdez-Aguirre,     Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, United States

Fehmi Kerem Bilgin,     İzmir Bakirçay University, Faculty of Law, Menemen, İzmir, Turkey

Paula Bourke,     School of Biosystems and Food Engineering, University College Dublin, Dublin, Ireland

Hans Bouwmeester,     Division of Toxicology, Wageningen University and Research, Wageningen, the Netherlands

Adelia C. Bovell-Benjamin,     Food and Nutritional Sciences, Tuskegee University, Tuskegee, AL, United States

Julie Larson Bricher,     Quiddity Communications, Inc., McMinnville, OR, United States

Frank F. Busta,     University of Minnesota, Minneapolis, St. Paul, MN, United States

Kezban Candoğan,     Faculty of Engineering, Department of Food Engineering, Ankara University, Ankara, Turkey

Melissa M. Card,     Institute for Food Laws & Regulations, MSU, Michigan State University's College of Law, United States

Yifan Cheng,     Department of Food Science, Cornell University, Ithaca, NY, United States

M.B. Cole,     Head, School of Agriculture Food and Wine. University of Adelaide, Urrbrae, SA, Australia

Pamela L. Coleman,     Mérieux NutriSciences, Chicago, IL, United States

Firouz Darroudi,     Global Harminization Initiaitve (GHI), Section of Genetic Toxicology and Genomics, Oegstgeest, The Netherlands

Debdeep Dasgupta,     Department of Microbiology, Surendranath College-Kolkata, Kolkata, West Bengal, India

H.K.S. De Zoysa

Department of Bioprocess Technology, Faculty of Technology, Rajarata University of Sri Lanka, Anuradhapura, North Central Province, Sri Lanka

Department of Biology, University of Naples Federico II, Naples, Italy

Ahmad Din,     National Institute of Food Science & Technology, University of Agriculture, Faisalabad, Pakistan

Hazel Farrell,     The New South Wales Department of Primary Industries, Taree, NSW, Australia

Anthony J. Fontana,     Mérieux NutriSciences, Chicago, IL, United States

Neal D. Fortin,     Institute for Food Laws and Regulations, Michigan State University, East Lansing, MI, United States

Beatriz Gonçalves Franco,     Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, United States

L.G.M. Gorris,     Food Safety Expert, Food Safety Futures, Nijmegen, The Netherlands

Jaap C. Hanekamp

University College Roosevelt, Middelburg, the Netherlands

Environmental Health Sciences, University of Massachusetts Amherst, Amherst, MA, United States

HAN-Research, Zoetermeer, the Netherlands

Helen Nonye Henry-Unaeze,     Department of Food, Nutrition and Home Science, Faculty of Agriculture, University of Port Harcourt, East-West Road Choba, Rivers, Nigeria

Alison Imlay,     The New South Wales Department of Primary Industries, Silverwater, NSW, Australia

Heinz-Dieter Isengard,     University of Hohenheim, Institute of Food Science and Biotechnology, Stuttgart, Germany

Lauren S. Jackson,     U.S. Food and Drug Administration, Division of Food Processing Science & Technology, Bedford Park, IL, United States

Sewon Jeong,     BiofoodCRO, Seoul, Korea

Katy A. Jones,     FoodLogiQ, Durham, NC, United States

Frans W.H. Kampers,     Wageningen UR, Wageningen, the Netherlands

Larry Keener,     International Product Safety Consultants, Seattle, WA, United States

Ji Yeon Kim,     Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul, Korea

Thea King,     The New South Wales Department of Primary Industries, Silverwater, NSW, Australia

Tatiana Koutchma,     Agriculture and Agri Foods, Canada

Oran Kwon,     Department of Nutritional Science and Food Management, Graduate Program in System Health Science and Engineering, Ewha Womans University, Seoul, Korea

Joe Lederman,     FoodLegal, Australia

Huub Lelieveld,     Global Harmonization Initiative (GHI), Vienna, Austria

Rebeca López-García,     Logre International Food Science Consulting, Mexico

Alida Mahmudova,     Bona Mente Consulting LLC Law Company, Azerbaijan

Bernard Maister,     Intellectual Property Unit, University of Cape Town, Cape Town, South Africa

Carmen I. Moraru,     Department of Food Science, Cornell University, Ithaca, NY, United States

Sangsuk Oh,     Department of Food Science and Technology, Ewha Womans University, Seoul, Korea

Margherita Paola Poto,     K. G. Jebsen Centre for the Law of the Sea, UiT, Tromsø, Norway

Jamuna Prakash,     Global Harmonization Initiative, Austria

Syed S.H. Rizvi,     Department of Food Science, Cornell University, Ithaca, NY, United States

V.D. Sattigeri,     Food Safety and Analytical Quality Control Laboratory, Central Food Technological Research Institute, Mysuru, Karnataka, India

Bert Schwitters,     Independent Researcher

Craig Shadbolt,     The New South Wales Department of Primary Industries, Silverwater, NSW, Australia

Xian-Ming Shi,     MOST-USDA Joint Research Center for Food Safety, School of Agriculture and Biology, State Key Lab of Microbial Metabolism, Shanghai Jiao Tong University, Shanghai, China

Ga Young Shin,     Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, United States

Mungi Sohn,     Food Science and Biotechnology, College of Life Sciences, Kyung Hee University, Republic of Korea

Cynthia M. Stewart,     Silliker Food Science Center, South Holland, IL, United States

Juanjuan Sun,     Food Law, Nantes University of France, Center for Coordination and Innovation of Food Safety Governance, Renmin University, Beijing, China

Elizabeth A. Szabo,     The New South Wales Department of Primary Industries, Silverwater, NSW, Australia

John Szpylka,     Mérieux NutriSciences, Chicago, IL, United States

John Y.H. Tang,     Universiti Sultan Zainal Abidin, Terengganu, Malaysia

Matthew D. Taylor,     The New South Wales Department of Primary Industries, Taylors Beach, NSW, Australia

The International Commission on Microbiological Specifications for Foods,     www.icmsf.org

Halide Gökçe Türkoğlu,     İzmir Bakirçay University, Faculty of Law, Menemen, İzmir, Turkey

Altinay Urazbaeva,     Studying Advanced Master Program in European, International Business Law, Leiden University

M.A.J.S. van Boekel,     Food Quality & Design Group, Wageningen University & Research, Wageningen, the Netherlands

Bernd van der Meulen,     GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law, Amsterdam, The Netherlands

Mandyam C. Varadaraj,     Department of Human Resource Development, Central Food Technological Research Institute, Mysore, Karnataka, India

Yuriy Vasiliev,     Stavropol Branch, North Caucasus Civil Service Academy, Russia

Viduranga Y. Waisundara,     Australian College of Business & Technology - Kandy Campus, Peradeniya Road, Kandy, Central Province, Sri Lanka

Odel Yun LI,     Shanghai Jiao Tong University, Shanghai Legislative Research Institute, Shanghai, China

Chapter 1: Introduction

Ensuring global food safety: A public health priority and a global responsibility

Julie Larson Bricher     Quiddity Communications, Inc., McMinnville, OR, United States

Abstract

Dr. Margaret Chan's words served as the opening quote of this book during its first publication nearly a decade ago. We have seen improvements in global health outcomes in the past 10 years, in part due to political and community pressure to implement evidence-based and scientifically informed health and food safety policies and legislation on a global scale. Chan's words ring especially true today: It was only through community effort that these improved outcomes were achieved—and it is only through continued community effort that we can ensure that safe food in adequate supply is the reality for all the world's people.

Keywords

Food safety; Foodborne disease; Food and Agriculture Organization; Globalization; Risk analysis

Only if we act together can we respond effectively to international food safety problems and ensure safer food for everyone.

Dr. Margaret Chan, former Director-General, World Health Organization.

Dr. Margaret Chan's words served as the opening quote of this book during its first publication nearly a decade ago. We have seen improvements in global health outcomes in the past 10 years, in part due to political and community pressure to implement evidence-based and scientifically informed health and food safety policies and legislation on a global scale. Chan's words ring especially true today: It was only through community effort that these improved outcomes were achieved—and it is only through continued community effort that we can ensure that safe food in adequate supply is the reality for all the world's people.

The march toward globalization appears inexorable, even as the trend remains politically controversial on the world stage. The International Monetary Fund defines globalization as the process through which an increasingly free flow of ideas, people, goods, services, and capital leads to the integration of economies and societies (IMF, 2006). At its core, globalization is a process driven by free trade economics and an ideal driven by the promise of greater societal benefits for all peoples of the world.

Proponents put forward that an economy without borders spurs greater market competition and therefore economic freedom, driving down prices and increasing availability and variety of affordable goods and services for a greater number of people. In turn, globalization promises further benefits, such as increases in productivity, access to new technologies and information streams, and higher living, environmental, and labor standards for those in both developed and developing countries. Critics charge that inherent economic and infrastructure inequalities that exist between developed and developing nations preclude less developed and poorer nations from fully realizing these benefits.

Whatever the measurable positive benefits experienced by some countries in recent years, there remain tangible challenges not only brought on by the rapid acceleration of globalization in the world economy but the impact of global climate change on the planet's food supply. Perhaps there are no statistics more compelling than those of the 2018 World Resources Institute's report, Creating a Sustainable Food Future, which projects that the human population is expected to grow from 7 billion in 2010 to 9.8 billion in 2050. The demand for food is estimated to increase by more than 50% and demand for animal-based foods by nearly 70% (WRI, 2018). According to the report, major changes to the global food system—by farmers, food companies, consumers, and governments—will be necessary to mitigate looming food shortages worldwide.

In addition, nearly 2decades into the 21st century, the challenges of ensuring food security, food safety, and nutrition on a global scale continue to grow in complexity. Recent statistics show that the levels of world hunger, malnutrition, and food- and waterborne diseases are among the most critical global public health issues facing the international community. For example:

• According to the Food and Agriculture Organization (FAO) of the United Nations, 10.9% of the world's population are undernourished, down from 14.5% in 2005. This percentage still represents roughly 770 million people (FAO, 2018).

• Globally, 22.7% of children under five who experience undernourishment suffer from stunted growth (FAO, 2018).

• The World Health Organization (WHO) reports that more than 1000 children under five die daily from diarrheal disease caused by inadequate access to water sanitation (WHO, 2014).

• In 2015, foodborne diarrheal disease agents alone were the cause of death for more than 230,000 people (WHO, 2018; WHO 2015).

• Worldwide, nearly 1 in 10 people fall ill from all foodborne diseases, which equates to 33 million healthy life years lost and results in the deaths of approximately 420,000 people (WHO, 2015). Children account for one-third of deaths from foodborne diseases.

• In developed countries, one in three consumers get a foodborne disease associated with microbes or their toxins every year. This does not include other foodborne diseases associated with naturally occurring or man-made chemical contaminants, such as aflatoxin, acrylamide, furan, or dioxin (Schlundt, 2008).

The WHO Initiative to Estimate the Global Burden of Foodborne Diseases identifies the rapid globalization of food trade as a worldwide trend that has introduced an increased potential for contaminated food to adversely affect greater numbers of people (WHO, 2015). As the food supply chain becomes more integrated, the potential for massive foodborne illness outbreaks caused by pathogens, chemicals, viruses, and parasites increases—as do the difficulties in controlling foodborne infections, morbidity, disability, and mortality.

Rapid globalization also has exposed critical gaps in national and international capabilities to assure adequate levels of food safety and quality. Disparities related to national infrastructural and technological capacities and international food production, distribution and handling standards, and law have become more visible as global commerce becomes more interconnected. As a result, WHO and other food-related international public health, development, and standard-setting bodies have targeted these gaps as priority items and are working together to reinforce the need to use an integrated international food safety regulatory system in the era of one global market.

To be effective, such a system must include advancing the use of risk analysis and management to better direct resources toward areas of high risk, providing a scientific basis for international food safety action, moving from conventional vertical legislation within nations to more horizontal rulings among nations to attain harmonization of standards and reduce barriers to trade, and building capacity to promote the availability and use of new food safety technologies, testing and preventing strategies that will reduce the public health risks of foodborne disease around the globe.

In the second edition of this volume, Ensuring Global Food Safety—A Public Health Priority and a Global Responsibility, members of the Global Harmonization Initiative (GHI) once again contribute to the world dialogue, discussing tools for promoting harmonization of scientific methods, standards, and regulations. Established in 2004, GHI is a network of international scientific organizations and individual scientists that aims to achieve objective consensus on the science of food regulations and legislation to ensure the global availability of safe and wholesome food products for all consumers.

With support and participation of its individual members and member organizations, the GHI's Working Groups have conducted a series of meetings at which members have formulated approaches to critically (re-)evaluate the scientific evidence used to underpin existing global regulations in the areas of product composition, processing operations, and technologies or measures designed to prevent foodborne illness. Each chapter is reflective of outcomes of these discussions and progress in developing strategies to find the shortest route to achieving global harmonization in concert with international public health and food safety authorities, including the WHO, FAO, the Codex Alimentarius Commission (CAC), and the International Organization for Standardization (ISO).

GHI's overarching objective is to provide regulators, policymakers, and public health authorities with a foundation for sound, sensible, science-based international regulations in order to eliminate hurdles to scientific advancement in food safety technology. For example, there is no question that the more that the avenues of global trade narrow, the higher the probability of traffic jams in worldwide commerce. Barriers to trade in the form of differing—and sometimes conflicting—country-by-country import/export rules and requirements can and do make it difficult for food businesses to get traction in overseas markets.

Food safety concerns are frequently cited by individual nations as underpinning the justification for their legislative acts and rulemaking—and for erecting trade barriers and other measures that have the impact of curtailing free trade. Unfortunately, in some cases, the science used to inform and bolster food safety policymaking is insufficient, inconsistent, or contradictory, creating a roadblock to the promulgation of laws that have a clear and evident benefit to protecting public health.

National differences in food safety regulations and laws also trigger a red light to the advances offered by science and technology. Though many food companies throughout the world have invested significant monies to food safety and nutrition technology research and development efforts, industry is understandably hesitant to apply newly developed capabilities on an international scale in an uncertain, maze-like regulatory environment.

GHI anticipates that elimination of regulatory differences will make it more attractive for the private sector to invest in food safety and nutrition research and development, consequently strengthening the competitiveness of each nation's food industry and of the industries supplying the food sector. Harmonizing global regulations will aid in the uptake and application of new technologies and encourage the food industry to invest in technologies to ensure the safety, quality, and security of the global food supply.

Ultimately, globalizing food safety regulations and laws based on sound science can only serve to help bridge public health gaps and create opportunities for all stakeholders to realize the big picture benefits promised by economic globalization, including measurable global reductions in morbidity and mortality associated with foodborne disease; increases in food availability to combat malnutrition and enhance food security for consumers worldwide; and decreases in poverty rates among less-developed or impoverished nations through capacity building that enables full participation in the global economy.

For public health agencies responsible for overseeing the safety of the international food supply, harmonization of food safety and quality standards and regulations will bring a higher level of confidence that risk reduction strategies and food safety measures are effective and that decisions taken are based on science and not on underlying political agendas that may be in conflict with public health goals. Harmonization will also ensure that available resources are allocated where they have the highest impact on the most pressing food disease–related problems.

To paraphrase WHO Director General Chan, it is only through collective action that we can fully embrace our global responsibility to respond effectively to the challenges of ensuring food security, food safety, and nutrition for everyone. As the authors in this volume attest, meeting that global responsibility requires cooperation, collaboration, and consensus building if we are to achieve harmonization of food regulations and standards, and thereby accomplish even greater gains in global public health.

References

1. Food and Agriculture Organization. World Food and Agriculture - Statistical Pocketbook 2018. 2018. http://www.fao.org/publications/card/en/c/CA1796EN.

2. International Monetary Fund, . Glossary of Selected Financial Terms. 2006. http://www.imf.org/external/np/exr/glossary/showTerm.asp#91.

3. Schlundt J. Food safety: a joint responsibility. In:  14th World Congress of Food Science and Technology. Shanghai, China. October 20, 2008 . 2008.

4. World Health Organization. Preventing Diarrhoea through Better Water, Sanitation and Hygiene. 2014. https://www.who.int/water_sanitation_health/publications/gbd_poor_water/en.

5. World Health Organization. WHO Estimates of the Global Burden of Foodborne Diseases: Foodborne Disease Burden Epidemiology Reference Group, 2007–2015. 2015. http://www.who.int/iris/handle/10665/199350.

6. World Resources Institute, . Synthesis Report: Creating a Sustainable Future: A Menu of Solutions to Feed Nearly 10 Billion People by 2050. 2018 Full report to be published in 2019. www.wri.org/publication/creating-sustainable-food-future.

Chapter 2: Safety and security

the costs and benefits of traceability and transparency in the food chain

Katy A. Jones     FoodLogiQ, Durham, NC, United States

Abstract

The food supply chain is one of the most important business aspects of food companies and restaurants. It is critical to every operation and provides organizations with the opportunity to build and deliver their brand promise. An efficient, well-managed food supply chain can help to improve operational efficiency, mitigate risk, improve brand reputation, and increase (or maintain) consumer confidence in the products being served to customers.

Keywords

Centers for disease control and prevention; Food and drug administration; Food safety; Food supply chain; Transparent marketing

The food supply chain is one of the most important business aspects of food companies and restaurants. It is critical to every operation and provides organizations with the opportunity to build and deliver their brand promise. An efficient, well-managed food supply chain can help to improve operational efficiency, mitigate risk, improve brand reputation, and increase (or maintain) consumer confidence in the products being served to customers.

But these benefits are only achievable if supply chains are kept safe and secure. This requires supply chains that are monitored and tracked using strong processes supported with advanced technologies. As a food company or restaurant, it is critical to track and monitor the supply chain to reduce the overall risk to the brand—and to the customers. In this chapter, we will look into the costs of foodborne outbreaks not only to society but to the impact of the business as well.

2.1. The burden of foodborne outbreaks

2.1.1. Each year 48 million people get sick from foodborne illnesses, 128,000 are hospitalized, and 3000 die (Centers for Disease Control and Prevention, 2015)

Many people are under the assumption that foodborne illness is more of a problem in developing countries where regulations are not as strict, but it hits closer to home more often than we think. The Centers for Disease Control and Prevention (CDC) in the United States of America closely monitor all cases of foodborne illness that come through the United States, and the statistics are not pretty.

It's nearly impossible to eradicate foodborne illnesses. There are too many factors that go into it, some out of our control, but more can be done for prevention. When organizations employ enhanced traceability programs, combined with effective safety plans, auditing and corrective actions, the risks of contamination can be much lower. Depending on where you are, companies should be able to monitor exactly where their food was, is, and will be, maintaining total visibility across the supply chain—and react quickly when a food safety issue hits.

Additionally, when foodborne illnesses occur, traceability can reduce exposure. As soon as the adulterated food is identified and the root cause is identified, it can be recalled to prevent further illness and used to analyze the medical action needed to rectify the situation.

2.1.2. About 23% of U.S. food recalls cost the food industry over $30 million and 14% cost organizations over $50 million (Grocery Manufacturers Association, 2011)

These statistics are staggering. Executing a recall on food products can be a manufacturer's worst nightmare simply because of the time and money lost. Recalling products is an essential part of maintaining public health, but it can be stressful.

Consider one E. coli outbreak in Germany (Centers for Disease Control and Prevention, 2014). It's difficult to contain, and in this instance, there was not strong traceability throughout the supply chain. 3800 people were affected worldwide, 47 died, and European Union farmers lost €417 million ($611 million) (Grieshaber, 2011). The holistic cost of this incident shows that traceability is essential to healthy food industries.

And according to a study from researchers at John Hopkins Bloomberg School of Public Health, a single foodborne disease outbreak at a fast-casual establishment could cost between $6330 and $2.1 million in lost revenue, fines, and lawsuits. And this is only on the financial side.

2.1.3. Reducing foodborne illnesses by just 1% would prevent nearly 500,000 Americans from getting sick each year

If we were able to reduce foodborne illness by 1%, nearly 500,000 Americans could avoid sickness. This will require a more strategic approach from individuals and food organizations alike.

Reducing foodborne illnesses so drastically will require a new perspective on how we view foodborne illnesses and mitigate risks. In 2013, the United States spent about $40 million on treating the problem but not preventing it. Through the adoption of traceability supported by technology, organizations can shift the focus toward prevention, saving money, and lives.

Reducing foodborne illnesses will not be an easy task, and it relies on individual organizations making decisions that impact society as a whole. As they employ traceability, they will start to make an impact and take us closer to reducing these issues.

2.2. The food supply chain: increasing risk

Food supply chains are growing increasingly complex, global, and fresh. Consumers are driving for more fresh format concepts and want healthier options overall. Yet that profile of supply chain in theory has increased risk.

Fresh produce items like cilantro, cucumbers, cantaloupes, and peppers that are often eaten raw cause more foodborne illness than any other single category of food, according to a study by the Center for Science in the Public Interest (CSPI) (Food Safety News, 2015). The nonprofit food safety group reviewed 10 years of outbreak data to determine which foods are most often linked to outbreaks of foodborne disease and identify trends in illnesses. Over the period studied, fresh produce caused 629 outbreaks and almost 20,000 illnesses.

But that does not mean Americans should avoid fruits and vegetables, CSPI says. While the number of outbreaks and illnesses is large, on a pound-for-pound basis fresh produce is safer than many other foods.

Over the period studied, there was a total of 193,754 illnesses reported from 9626 outbreaks. Of the total number of reported outbreaks, the CDC was able to identify both the food source and the contaminant in fewer than 40%. CSPI only reviewed the 3485 solved outbreaks.

The report also found that seafood caused more illnesses per pound consumed than any other food category, while fruits, vegetables, and dairy caused the fewest illnesses per pound consumed.

2.3. Working toward traceability and transparency

Now that we have established the burden of the issue and the associated risk in the food supply chain, we ask ourselves what are the real costs associated with a failure in transparency and traceability?

Food regulatory requirements have shifted in nature; now, rather than primarily focusing on responding to food safety incidents, there is an increased emphasis on food safety prevention. Fortunately, there are a variety of tools to help food and beverage manufacturers ensure that they are compliant with food safety regulations; the key is preparing for food safety audits in advance. Audits can occur in-house by a dedicated team or by an external auditor, with the purpose being to identify areas for improvement to processes and systems.

Under U.S. Food and Drug Administration (FDA) guidelines and regulations under the Food Safety Modernization Act, food and beverage manufacturers must have a food safety plan in place that includes oversight and management of preventive controls established in each manufacturing facility. Regulatory audits and audit reports must be submitted to the FDA. In 2019, the FDA announced the New Era of Smarter Food Safety initiative that encompasses four pillars that include tech-enabled traceability, smarter tools for prevention, adapting to new business models in retail, and food safety culture. The blueprint released also includes proposed Section FSMA 204 rulemaking to harmonize the key data elements and critical tracking events needed for enhanced traceability (FDA New Era of Smarter Food Safety).

In Europe, the European Food Safety Authority (EFSA), established in 2002, oversees the regulation of the food supply chain. The organization's mission is to deliver independent, high-quality and timely scientific advice on risks in the food chain from farm to fork in an integrated manner and to communicate on those risks in an open manner to all interested parties and the public at large.

The exact same law that established EFSA, Regulation EC/178/2002, also established the basis for food traceability in Europe. Under the law, any food produced in Europe or imported into Europe is subject to an incredibly high standard for traceability. The regulation requires that both food manufacturers and distributors demonstrate the ability to trace and follow food, feed, and ingredients through all stages of production, processing, and distribution (European Commission, 2019).

Although going through an audit can be a stressful event, a passing result will assure you and your team that your company has achieved a satisfactory level of food safety. A successful audit also lets consumers know that your company prioritizes their wellbeing.

2.4. The costs associated to a lack of traceability

With a managed, improved, and efficient food supply chain in place, businesses can begin to reap other benefits. This can include financial gains, such as an increase in credit request approvals and a reduction in insurance premium costs.

2.4.1. Issues with labeling and brand claims

Providing proof of your product claims is by itself enough to boost your business' reputation in the industry and worldwide. With access to robust supply chain data, companies can proactively remove any issues that may negatively impact your brand in the future. By identifying quality issues in advance, you can protect your brand commitment and your business' reputation.

For example, you can communicate across your supply chain to prevent poor or tainted products from being delivered to your consumer. To examine the real potential return on investment that supply chain transparency can achieve, let us look at an example:

A consumer packaged goods company that produces nut-free granola bars has been notified that a lot from its oat supplier actually contained traces of walnut, when the allergen claim on the packaging does not list tree nuts. The issues have only been identified after the batch has been sent out to retailers and put on shelves. The batch of 1500 cases had an average sale price of $40, totaling $60,000 worth of sales. $20,000 of that sales figure was sunk manufacturing costs (the cost of the raw ingredients, manufacturing, and labor).

Without Supply Chain Traceability: The manufacturer is slow to respond to the crisis.

It takes time for staff to identify if the contaminated batch has been sent to figure out exactly which stores were sent the tainted product. This equates to a labor cost of $1,000. Once the shipment locations have been identified, the manufacturer has the opportunity to get the sales back quickly if they can replace the product. There is a 6% logistics cost of $3,000 to recall the products and a $9,000 cost to expedite delivery of the new product. All of this is on top of the $20,000 cost of manufacturing the new product. This is a total cost of $33,000. However, because the product defect was not caught before it went on sale, the manufacturer's reputation is severely damaged. Consumers no longer trust their product, and they see a 20% drop in sales. The company's share price also falls as a result.

With Supply Chain Traceability: With enhanced traceability in place, the situation is a different story. Corporate food safety can use data to instantly see that the contaminated batch has only been sent to three store locations. The $1,000 labor cost is significantly reduced.

Companies that utilize traceability can also benefit from an average 30% reduction in the direct costs associated with a recall. So instead of the logistical costs totaling $12,000, the costs only total $8000. That is a saving of $4000.

Because the company is able to quickly respond to the issue and pull the tainted product from the exact store locations, the damage to their brand is greatly reduced. They may see a small reduction in sales but not near the damage caused from a long, drawn-out recall played out in the news media and social media.

2.4.2. Restrictions to market access

With globalization comes the opportunity for businesses to enter new markets across the world with relative ease. A traceable supply chain can help to ease compliance regulation on a global scale. With a traceable supply chain, you can ensure that all trading partners meet or exceed the minimum acceptable standards for markets across the globe.

Enhanced traceability connects every stage of the supply chain; the manufacturer was able to identify where the nuts entered the manufacturing process. The issue was the fault of a well-known supplier, not the manufacturer and it is the supplier that suffers the reputational damage. The manufacturer still sees a slight decrease in sales, but it is able to save its reputation and its share price.

2.5. Benefits beyond food safety

We all know the important role food supply chain traceability plays in food safety. Being transparent about where your food comes from helps put customers' minds at ease—and also can help resolve a food safety issue more quickly, should one arise. But what about the other benefits food supply chain traceability? Can being transparent about your supply chain provide an additional return of investments for your business, beyond safety?

Today's consumers are more concerned than ever about what they are eating and where their food is coming from. With this trend toward awareness and transparency, businesses can capitalize on additional benefits, simply by telling your customers more about your processes. Here is how:

2.5.1. Enhanced credibility

Being open about your supply chain shows you have nothing to hide. This transparency will resonate with customers and help build the credibility of your business as a trusted place to bring their business. Improving your credibility can also help to further establish your branding and help you stand out from the competition. Your customers will be more likely to choose you knowing they can trust where your food comes from.

2.5.2. Transparent marketing

Supply chain traceability allows you to create a farm-to-fork story that can be a very effective marketing tool. Consumers like to know they are putting good, clean ingredients in their body and they like to know they are supporting local farmers at the same time. By using your supply chain as a marketing tool, you can attract a health-conscious audience. While many companies like to claim their food is farm fresh, traceability allows you to authenticate your sources.

2.5.3. Increased reliability for consumers

Meticulously tracing your supply chain helps to ensure consistent quality of suppliers across each chain or franchise of your business. This means the food your customers eat is always exactly the same, regardless of which location they visit. This level of reliability and consistency helps solidify your brand and lets your customers know they can trust your product. Rather than worrying your food may be hit or miss depending on location, they will know what level of quality they can expect.

2.6. More operational efficiency

You depend on your supply chain to maintain efficiency in the daily operations of your business. Traceability helps to improve communication between you and your suppliers, which keeps everyone on the same page and helps improve efficiency. When your processes are running smoothly, your relationships with your suppliers, employers, and customers all benefit.

The benefits of food supply traceability go well beyond food safety. With the opportunity to improve your business' branding, marketing, reputation, and processes, traceability is an investment that can transform your entire business.

References

1. Centers for Disease Control and Prevention. Questions about the 2011 E. coli Outbreak in Germany. 2014 (accessed 19.10.10.). www.cdc.gov/ecoli/germany.html.

2. Centers for Disease Control and Prevention.  Surveillance for Foodborne Disease Outbreaks United States, 2013: Annual Report . 2015.

3. European Commission. Food Law General Requirements. 2019 (accessed 19.10.16.). https://ec.europa.eu/food/safety/general_food_law/general_requirements_en>. .

4. Food Safety News. Fresh Produce Responsible for Most Foodborne Illnesses in the U.S. 2015 (accessed 19.10.10.). www.foodsafetynews.com/2015/12/report-fresh-produce-responsible-for-most-foodborne-illness-outbreaks/.

5. Grieshaber K.  2 New E. coli Deaths as EU Holds Emergency Meeting . The Post and Courier; 2011.

6. Grocery Manufacturers Association.  Capturing Recall Costs: Measuring and Recovering the Losses . 2011.

7. FDA New Era of Smarter Food Safety, 2021.

Chapter 3: Food regulation around the world

Bernd van der Meulen ¹ , Melissa M. Card ² , Ahmad Din ³ , Neal D. Fortin ⁴ , Alida Mahmudova ⁵ , Bernard Maister ⁶ , Halide Gökçe Türkoğlu ⁷ , Fehmi Kerem Bilgin ⁷ , Joe Lederman ⁸ , Margherita Paola Poto ⁹ , V.D. Sattigeri ¹⁰ , Mungi Sohn ¹¹ , Juanjuan Sun ¹² , Altinay Urazbaeva ¹³ , and Yuriy Vasiliev ¹⁴       ¹ GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law, Amsterdam, The Netherlands      ² Institute for Food Laws & Regulations, MSU, Michigan State University's College of Law, United States      ³ National Institute of Food Science & Technology, University of Agriculture, Faisalabad, Pakistan      ⁴ Institute for Food Laws and Regulations, Michigan State University, East Lansing, MI, United States      ⁵ Bona Mente Consulting LLC Law Company, Azerbaijan      ⁶ Intellectual Property Unit, University of Cape Town, Cape Town, South Africa      ⁷ İzmir Bakirçay University, Faculty of Law, Menemen, İzmir, Turkey      ⁸ FoodLegal, Australia      ⁹ K. G. Jebsen Centre for the Law of the Sea, UiT, Tromsø, Norway      ¹⁰ Food Safety and Analytical Quality Control Laboratory, Central Food Technological Research Institute, Mysuru, Karnataka, India      ¹¹ Food Science and Biotechnology, College of Life Sciences, Kyung Hee University, Republic of Korea      ¹² Food Law, Nantes University of France, Center for Coordination and Innovation of Food Safety Governance, Renmin University, Beijing, China      ¹³ Studying Advanced Master Program in European, International Business Law, Leiden University      ¹⁴ Stavropol Branch, North Caucasus Civil Service Academy, Russia

Abstract

Against the background of global harmonization through scientific consensus, this chapter provides an inventory of approaches to the regulation of food and related issues in a variety of jurisdictions around the world. To each jurisdiction, a separate section is dedicated. Each section has been written by an author well versed in the jurisdiction at issue. The sections can be read as independent texts.

Keywords

Codex Alimentarius; Food law; Food regulation; Food safety; Labelingrisk analysis

Chapter 3.1

Introduction

Bernd van der Meulen     GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law, Amsterdam, The Netherlands

3.1.1. Purpose of this chapter

Against the background of global harmonization through scientific consensus, this chapter provides an inventory of approaches to the regulation of food and related issues in a variety of jurisdictions around the world. To each jurisdiction, a separate section is dedicated. Each section has been written by an author well versed in the jurisdiction at issue. The sections can be read as independent texts.

3.1.2. Food law

We have labeled the rules and regulations that apply to the food sector food law. This label can cover two closely related but distinguishable phenomena. It may relate to a branch of law recognized within a legal system that is labeled food law or the outcome of an analysis of the legal system from the perspective of the food sector. If the latter, one can speak of a functional feed of law. ¹ In this chapter, we approach the topic from this functional perspective.

3.1.3. Framework of analysis

The sections differ considerably due to differences in the subject matter, in the availability of data and in background and style of the authors. For the purpose of comparative analysis, some points of attention have been chosen. These include the presence or absence of a branch of food law; the most important sources of food law; game changing events that triggered development or reform; the role of science through risk analysis; the role of the Codex Alimentarius in national systems; the institutional framework; underlying principles and concepts; the role of product specific requirements (standards); authorization requirements; food safety limits; process requirements on hygiene and incident management; labeling; human right to food; and jurisdiction specific elements. Where available, literature in English has been indicated. ²

In this chapter, the sections are grouped by region. The chapter opens with a brief section on International food law—the Codex Alimentarius in particular—because this has been chosen as benchmark in many jurisdictions. Then follows the section on the United States of America. The United States of America were relatively early in developing modern food law. Many other jurisdictions have taken the United States' experiences and examples into account in their systems. The chapter concludes with a reflection from the perspective of global harmonization.

Further reading

Van der Meulen, B.M.J. (2018). The Functional Field of Food Law. The Emergence of a Functional Discipline in the Legal Sciences, European Institute for Food Law working paper 2018/02. Available at: http://www.food-law.nl/Working-papers/.

Chapter 3.2

International food law

Bernd van der Meulen     GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law, Amsterdam, The Netherlands

3.2.1. Codex Alimentarius

Between 1961 and 1963 the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) established the Codex Alimentarius Commission (CAC). Over the years, the CAC established specialized committees. These committees are hosted by member states all over the world. Some 188 members (187 countries and the EU), representing about 99% of the world's population, participate in the work of Codex Alimentarius (Van der Meulen, 2018).

Food standards are established through an elaborate procedure of international negotiations (FAO/WHO, 2016). All standards taken together are called "Codex Alimentarius. In Latin, this means food code" It can be seen as a virtual book filled with food standards. The food standards represent models for national legislation on food.

By July 2015 ³ the total output of the Codex Alimentarius stood at: 191 commodity standards, 73 guidelines, 51 codes of practice, and 17 maximum levels for contaminants in foods; over 3770 maximum limits for food additive in foods covering 301 different additives, 4347 maximum residue limits for pesticide residues covering 196 pesticides, and 610 maximum residue limits of veterinary drugs in foods covering 75 veterinary drugs. Finally, the Codex Alimentarius includes requirements of a horizontal nature on labeling and presentation and on methods of analysis and sampling (FAO/WHO, 2016; Masson-Matthee, 2007; Van der Meulen, 2018).

3.2.2. Procedural manual

The constitution of the Codex Alimentarius is the Procedural Manual. The Procedural Manual not only provides the procedures and format for setting Codex Standards and Guidelines, but also some general principles and definitions (Table 3.2.1). The principles relate, among other things, to the scientific substantiation of the work of Codex Alimentarius and the use of risk analysis for food safety (Table 3.2.2).

3.2.3. Standards

The work of the CAC has resulted in a vast collection of internationally agreed food standards that are presented in a uniform format. Most of these standards are of a vertical (product specific) nature. They address all principal foods, whether processed, semiprocessed, or raw. Standards of a horizontal nature are often called general standards, like the General Standard for the Labeling of prepackaged Foods. ⁴

According to this general standard, the following information shall appear on the labeling of prepackaged foods:

• the name of the food; this name shall indicate the true nature of the food;

• list of ingredients (in particular if one of a list of eight allergens is present);

• net contents;

• name and address of the business;

• country of origin where omission could mislead the consumer;

• lot identification;

• date marking and storage instructions;

• instructions for use.

3.2.4. Codes

In addition to the formally accepted standards, the Codex includes recommended provisions called codes of practice or guidelines. There is, for example, a Code of Ethics for International Trade in Food, ⁵ and a set of hygiene codes like the Recommended International Code of Practice General Principles of Food Hygiene and the Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Table 3.2.3).

3.2.5. Legal force

The Codex standards do not represent legally binding norms. They present models for national legislation. Member states undertake to transform the Codex standards into national legislation. However, no sanctions apply if they do not honor this undertaking.

By agreeing on nonbinding standards, the participating states develop a common language. All states and other subjects of international law will mean the same thing when they meet to negotiate about food (i.e., food as defined in the Codex). The same holds true for milk and honey and all the standards that have been agreed upon. The notion of HACCP has been developed—and is understood—within the framework of Codex Alimentarius. ⁶ In this way, the Codex Alimentarius provides a common frame of reference, but there is more.

Table 3.2.1

Table 3.2.2

Table 3.2.3

The mere fact that national specialists on food law enter into discussion on these standards will influence them in their work at home. Civil servants drafting a piece of legislation will look for examples. As regards food, they will find examples in abundance in the Codex. In these subtle ways, the Codex Alimentarius is likely to have a major impact on the development of food law in many countries even without a strict legal obligation to implement.

It turns out more than once that soft law has a tendency to solidify. Once agreements are reached, parties tend to put more weight on them than was initially intended. This is true for Codex standards as well which, following several developments, eventually acquire at least a quasibinding force.

3.2.6. WTO/SPS

The World Trade Organization ⁷ (WTO) tries to remove barriers to trade. To achieve this, several measures have been taken. Tariff barriers were reduced and to the extent that this was successful nontariff barriers became more of a concern. The basic treaty addressing trade in goods is the General Agreement on Tariffs and Trade (GATT). The GATT recognizes that certain exceptions to free trade can be necessary to protect higher values like health and (food) safety.

In food trade, differences in technical standards like packaging requirements may cause problems, but it is mostly concerns about food safety, human health, animal, and plant health that induce national authorities to take measures which may frustrate the free flow of trade. To address these concerns, two WTO treaties were concluded: the Agreement on Technical Barriers to Trade (the TBT Agreement) and the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement).

The SPS Agreement was drawn up to ensure that countries only apply measures to protect human and animal health (sanitary measures) and plant health (phytosanitary measures) based on the assessment of risk, or in other words, based on science. The SPS Agreement incorporates, therefore, safety aspects of foods in trade. The TBT Agreement covers all technical requirements and standards (applied to all commodities), such as labeling, that are not covered by the SPS Agreement. Therefore, the SPS and TBT Agreements can be seen as complementing each other.

To a certain extent the WTO is a supranational organization. The treaties concluded between its members are binding. There is the Dispute Settlement Understanding, providing an arbitration procedure to resolve conflicts. If a party wants to present a conflict, a Dispute Settlement Body (DSB) is formed to arbitrate on the basis of WTO law. If a party does not agree with the decision of the DSB, it can take the case to an Appellate Body (AB). While the WTO does not have powers to enforce decisions taken in this arbitration procedure, it can condone economic sanctions by the winning party if the decision reached is not implemented by the party found at fault. These sanctions usually take the form of additional import levies on goods from the state found at fault. If the levies are condoned by the DSB (or the AB), setting them does not in itself constitute an infringement of WTO obligations.

As follows from the above, the SPS Agreement is very important from a food safety point of view. The SPS Agreement recognizes and further elaborates on the right of the parties to this agreement to take sanitary and phytosanitary measures necessary for the protection of human, animal, or plant life or health. The measures must be scientifically justified, and they may not be discriminating, nor constitute disguised barriers to international trade.

If the measures are in conformity with international standards, no scientific proof of their necessity is required. These measures are by definition considered to be necessary. The most important international standards regarding SPS are set by the so-called three sisters of the SPS Agreement: The Codex Alimentarius Commission, the International Office of Epizootics (OIE ⁸ ), and the Secretariat of the International Plant Protection Convention (IPPC). The standards on food and on food safety are mainly to be found in the Codex Alimentarius. ⁹

3.2.7. Conclusion

The inclusion of the Codex Alimentarius in the SPS Agreement greatly enhances its significance. WTO members who follow Codex standards are liberated from the burden of having to prove the necessity of their sanitary and phytosanitary measures. National measures not based on Codex have to be proven to be science based.

References

1. FAO/WHO. Understanding Codex. 2016 Rome. www.fao.org/3/a-i5667e.pdf.

2. Masson-Matthee M.D. The Codex Alimentarius Commission and its standards. In:  An Examination of the Legal Aspects of the Codex Alimentarius Commission . The Netherlands: Asser Press; 2007.

9000. van der Meulen B.M.J. Codex Alimentarius: The Impact of the Joint FAO/WHO Food Standards Program on EU Food Law European Institute for Food Law Working Paper 2018/04. 2018. http://www.food-law.nl/Working-papers/.

Further reading

Codex Alimentarius Commission. Procedural Manual. Rome: FAO/WHO; 2018. www.fao.org/documents/card/en/c/I8608EN.

Chapter 3.3

United States of America

Neal D. Fortin     Institute for Food Laws and Regulations, Michigan State University, East Lansing, MI, United States

3.3.1. Introduction

And chalk and alum and plaster are sold to the poor for bread.

—Alfred Lord Tennyson, Maud (1886).

3.3.1.1. What is food law?

The history of adulteration and misrepresentation of food is as old as trade in food (Hart, 1952). Consequently, the history of food law designed to thwart adulteration and misrepresentation runs as far back as the history of commerce itself (Hart, 1952).

The earliest food law in the United States extends back into the colonial years and the adoption of British common law. The essence of the common law was plain and direct: (1) Do not poison food and (2) Do not cheat (Hutt, 1960).

Under the common law, adulterated food consisted of food that was unfit for human consumption or contained some deleterious substance, whereby rendering it dangerous to health (Ibid.) Food labels were infrequent, so correspondingly there was no common-law offense of mislabeling. However, the common-law offense of false representation of merchandise for sale is similar to the present day offense of false labeling (Ibid.)

For most of recorded history (throughout the world), food law revolved around these two pillars: regulation against adulteration and misrepresentation. Food production and consequently food law has grown more complex, but these fundamental pillars remain. Food law remains as the body of public law designed to prevent adulteration and mislabeling.

Among U.S. academics, it is vogue today to use food law expansively to include any area of law or even policy that is related to food. For example, crop insurance law affects the price of farm commodities used for food, ergo food law; animal welfare law applies to livestock used for food, ergo food law; water quality issues arising from manure in animal husbandry are part of food production, ergo food law. This broad context reminds us that our food supply is connected to agriculture, the environment, and social issues. Nonetheless, this expansive definition diverges from tradition, and this scope