Introduction

Kuei-Jung Ni and Ching-Fu Lin

If people let government decide what foods they eat, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.

Thomas Jefferson (1743-1826)

Food is not only produced from traditional agricultural practices for consump­tion but also from complex industrial processes. Increasingly, new processes and production methods involving technologies and medicines have changed the perception of food. Modern food processes and production methods have brought about a variety of benefits,¹ making food growth faster, more afford­able, and in some cases healthier. In particular, food produced with the help of emerging technologies such as genetic engineering may relieve food insecurity and hunger in developing countries, as climate change has made these prob­lems worse.²

To be sure, these beneficial results should be appreciated, and national poli­cies to promote agri-technologies and industry are largely desirable. However, their uncertain risks and unknown hazards may also come into play in the future, and thus, they cannot be ignored. The demand to balance food pro­duction with increasing health concerns is also essential, especially from the perspective of the right to health and the right to safe food.

Pesticides, additives, and animal drugs, including hormones, ractopamine, and antibiotics, have been commonly used, but they continue to concern con­sumers and have garnered conflicting views over their safety across the globe. Food-borne hazards carrying both potential risks and benefits have also raised controversies over the methods and approaches of government approval and phase-out of the uses. For example, the European Union (EU), relying on stud­ies conducted by the European Food Safety Authority (EFSA) on the residuals

1 “The United States Department of Agriculture (USDA): Biotechnology Frequently Asked Ques­tions—What are the benefits of Agricultural Biotechnology?” available at www.usda.gov/topics/ biotechnology/biotechnology-frequently-asked-questions-faqs.

2 Kaiser Jamil, “Biotechnology—A Solution to Hunger? The United Nations Chronicle”, available at www.un.org/en/chronicle/article/biotechnology-solution-hunger.

DOI: 10.4324/9781003271918-1 of hormones^[3] and ractopamine, still prohibits the importation of animal foods containing these drugs.^[4] Although antibiotics have been banned for feeding animals in the EU, the United States (U.S.) has yet to phase out the practice officially. Instead, it applies a voluntary policy in discouraging the industry from the practice.^[5]

Further, rapid advances in agri-food technologies have brought increasing complexity and emerging challenges to food safety regulation and govern­ance along the global supply chain.^[6] One strong example can be found in the long-debated issue of genetically modified (GM) crops. Despite their potential economic benefits, GM crops have encountered public fears and controversies over scientific evidence and risk assessment.

Such controversies have greatly divided countries like the U.S. and the EU in terms of their regulatory approaches and have further led to various trade disputes within the World Trade Organization (WTO)^[7] and beyond. Through rapid technological development, a growing number of various GM foods con­tinue to enter the market, such as GM salmon farming and sales in North America that have attracted both scholarly and practical concerns over food safety, biodiversity, and regulatory adequacy. Because there is no solid evidence demonstrating the health risk of using such technologies, many GM foods have remained marketable, but they are subject to mandatory labels that have been widely applied both in the EU^[8] and the U.S.^[9]

Additionally, innovative and complex gene-editing technologies that involve CRISPR technology on various crops have also triggered a debate regarding whether the existing models of governance should be revised. There now seems no coherent approach for governing CRISPR tech­nology’s marketing approval.

Beyond GM or CRISPR-edited food products, more and more “novel foods” (e.g. cloned animal products, non-traditional plants, nanofood, and plant-based meat) and “functional foods” merit a review of existing regulatory frameworks and innovative institutional design to ensure better governance. Further, heightened public criticism in the areas of food safety and technology poses significant challenges to governments around the world, which are strug­gling to strike a proper balance between technocracy- and democracy-oriented risk governance models. Similarly, legitimacy, transparency, and accountability issues are of paramount importance in shaping and reshaping local, national, regional, international, and even transnational frameworks for food safety regu­lation and technology governance.

On the other hand, new technology may also serve as a governance tool that enables regulators and businesses to better protect consumers from prob­lems such as contamination or food fraud. The application of blockchain tech­nology to food tracing and tracking appears to be a crucial example. While blockchain is often linked to cryptocurrencies such as Bitcoin, it may also empower governance mechanisms to address food safety problems by facilitat­ing transparency and traceability. Many technology-based regulatory models have been recently adopted by giant transnational retailers along the global supply chain.

Ensuring food safety has become a local and global mandate and constitutes a benchmark by which governmental performance can be evaluated. We are living in a globalized world, where few countries may survive on their own. Trade in food and agricultural products continues to increase and amounted to USD 1.5 trillion in 2018.^[11] Harmonization of national food safety measures without compromising the appropriate national levels of protection is an una­voidable challenge facing the international community.

Concerning the global arena, the Codex Alimentarius Commission (CAC) was established to adopt international standards for food safety. The standards have been recognized as a benchmark by which to safeguard food safety, but it is still not binding per se,^[12] and the legitimacy of the adoption procedure con­tinues to be controversial.^[13]

The WTO has governed the application of sanitary and phytosanitary meas­ures affecting trade, including those for preserving food safety.^[14] WTO mem­bers are required to ensure observance of basic principles based upon science, transparency, proportion, non-discrimination, and so on.^[15] It nonetheless falls into nations’ regulatory space to pursue different levels of protection, meth­ods, and approaches to reach their policy goals. Observing trade disciplines alone cannot guarantee eventual local food safety.^[16] The Food and Agricul­ture Organization (FAO) and the World Health Organization (WHO) are two organs of the United Nations responsible for food safety management from a global perspective. The FAO and the WHO co-authored the document “Food Safety Risk Analysis,” which has been instrumental in guiding national authori­ties in establishing their food risk analysis regimes.^[17] Likewise, this blueprint, though useful, is not enforceable, as it is not intended to provide “prescriptive instructions on how to implement risk analysis.”^[18] An international framework may indeed contribute to the harmonization of regulations and standards and may also ease frictions.^[19] Proper food safety nonetheless still rests on responsive and effective national preparation and associated mechanisms.

All in all, the ever-changing landscape in the interaction between food safety and technology development raises a myriad of research questions from vari­ous analytical angles. What is the prospect for food safety governance at the local, national, regional, international, and transnational levels in the context of rapid technological development? Is the time ripe for us to review and rethink the existing regulatory framework for GM and/or CRISPR-edited food? How will disruptive technologies reconfigure the manner in which we formerly perceived and designed food safety regulations? Should we revisit the prevailing scholarly discourse on risk regulation in an era of disruptive technol­ogy? How should we evaluate regulatory effectiveness and efficiency in differ­ent governance phases, such as risk communication, risk assessments, and risk communication? What roles might private actors play in building new models of governance in collaboration with governments and civil societies? From a comparative law perspective, what do policy experiences and experiments in different jurisdictions tell us about shaping and reshaping contemporary food law and policy?

Good food safety systems must deal with a continually changing world, especially accommodating the challenges of sophisticated agriculture and food technologies.

This collected volume primarily reflects concerns surrounding how food and agri-technologies can be managed and regulated to ensure food safety. It is centered on reviewing and analyzing relevant regulatory regimes, of which relevant approaches, policies, principles, procedures, and mechanisms sustain­ing operations will be covered.

This book is largely based on a collection of papers presented at the Con­ference on Food Law and Policy focusing on the theme “Food Safety and Technology Governance,” which took place in Taipei, Taiwan, on May 10—11, 2019. The collection benefited from debates and discussions among partici­pants, including academicians, practitioners, and policy makers across the globe, who shared their interests in existing and emerging issues concerning food law and policy in the context of technology governance.

Under the analytical framework of the dynamic, normative interactions between food safety and technology governance, a number of prominent scholars and practitioners have come together from the U.S., EU, Japan, China, Korea, Association of Southeast Asian Nations (ASEAN), Malaysia, and Taiwan to offer their valuable expertise and insight. With great vision, this edited volume establishes an overarching framework for the interaction between food regulation and technology development, under which lie a series of dynamic and interactive scholarly examinations.

This collection is composed of four components and features a total of 14 chapters covering timely and crucial issues—from comparative approaches and regulations, the nanoscale substance in food, and CRISPR-edited crops to e-commerce and small and medium enterprises along the global food supply chain, blockchain-based food traceability mechanisms, and functional/healthy food management—this manuscript will be of significant academic and practi­cal value to the existing scholarship and policy landscape.

Risk governance systems in major jurisdictions such as the U.S. and the EU, which are premised upon a contemporary set of risk analysis principles and approaches, have increasingly been under stress due to the advent of various merging agri-food technologies. How such risk governance systems, which reflect the respective jurisdictions’ legal, scientific, social, economic, and politi­cal underpinnings, may be able to configure and reconfigure in the context of changing technology landscape merits scholarly examination. Part I includes three chapters that probe into the risk governance systems, principles, and approaches in the U.S. and the EU by way of specific case studies—antibiot­ics in food animals, nutrition and food assessments, and gene technology in food—and provides a new perspective for readers to rethink and reconceptual­ize the multifaceted roles risk governance plays in the area of food safety.

In Chapter 2, Kuei-Jung Ni of National Yang Ming Chiao Tung University reveals how the Food and Drug Administration (FDA) in the U.S. managed to solve the rampant use of antibiotics by, inter alia, voluntarily phasing out certain antibiotics used in animal feeding operations instead of engaging in the with­drawal of antibiotic permission. The chapter suggests that the precaution and cost-benefit analysis literally serve as principles and policy tools sustaining the FDA policy, as the inconclusiveness of relevant scientific findings remains and formal enforcement may not be cost effective. Apart from analyzing relevant judicial rulings on the voluntary approach, the author explores the implications of these principles underpinning the FDA’s policy for phasing out antibiotics, despite the absence of an explicit invocation by the FDA.

Chapter 3, authored by Alie de Boer of Maastricht University, unravels the role of EFSA as laid down in law and reviews the practical reality of scientific advice provided under the mandate of European food law, highlighting that health claims and benefit assessments make up a large portion of the work undertaken by the EFSA, although the exact methodologies to conduct such assessments are under-developed. The research questions asked in the chapter highlight the fundamental inquiries of contemporary food safety governance, particularly because risks regulation and scientific evidence are being treated as the basis of law and policy developments in Europe and beyond.

In Chapter 4, Neal Fortin of Michigan State University examines govern­ment oversight and jurisdictional overlaps in the U.S. in terms of regulating gene technology with food. At least nine different statutes that regulate dif­ferent aspects of gene technology with food are governed and enforced by three agencies, the U.S. Department of Agriculture (USDA), the FDA, and the Environmental Protection Agency (EPA). The chapter reveals that this frag­mented structure lends the appearance of disorganization, and the nomencla­ture in these statutes for various actions is occasionally inconsistent, but the deficiency does not indicate a lack of thoroughness in the oversights. Fortin also provides a hypothetical case study illustrating the navigation of a developer of a GM plant, through research and development to regulatory steps before commercialization.

Emerging technologies pose a diverse range of challenges and opportunities for the shaping and reshaping of food safety governance across borders. Part II assesses the ever-changing landscape in the interaction between food safety and technology development by way of in-depth case studies on e-commerce and the global food supply chain, the production of cell-cultured food products derived from livestock and poultry, and distributed ledger technology-enabled food traceability governance—and sheds new light on existing research ques­tions, with innovative analytical angles.

In Chapter 5, Kai-Chih Chang of Soochow University positions his analysis on the tensions and balances between health protection and the promotion of international trade along cross-border supply chains of food products. By way of an analysis of the WTP's SPS Agreement and recent free trade agreements, such as the Comprehensive and Progressive Agreement for Trans-Pacific Part­nership (CPTPP), the author discusses the regulatory challenges posed by scat­tered, small-scale, and potentially poorly declared shipments of food products to customs to conduct efficient and effective inspections and also explores how new e-commerce technologies and platforms may affect SME exports, SPS risk, and food safety regulation.

In Chapter 6, Ching-Fu Lin of National Tsing Hua University explores blockchain’s potential to revolutionize the global food supply chain, which seems particularly salient. This involves transforming paper-based documents into a blockchain-enabled identity to generate a high level of transparency and data integrity, enabling smaller farmers to bypass middlemen in crop trading and cash transfers and providing an efficient and cost-effective way to manage the production system. At the same time, as Lin points out, “blockchainiz- ing” the governance of food safety, traceability, and sustainability may also pose a new layer of regulatory questions about technical capacity and infrastruc­ture gaps, scalability and implementation costs, global standardization politics, cybersecurity and data protection, and the technologically inherent limits of blockchain, calling for a more technologically informed policy-making process before rushing into the hype of blockchainizing food law.

Chapter 7, authored by Steph Tai of the University of Wisconsin, raises cru­cial questions surrounding how to regulate the labeling of artificial meat, with a recent statute defining meat as something “derived from harvested produc­tion livestock or poultry.” While the USDA and FDA also propose that “both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry,” this chapter examines these legal actions in a broader food studies context and assesses how definitions have shaped and continue to shape consumer expectations of what constitutes vari­ous categories of food.

Regulators in different jurisdictions have been exploring optimal approaches to governing new food products derived from genome-edited technologies and/or novel materials. Part III discusses governance options and institutional design models for regulating gene-edited food products, as well as novel foods in Argentina, Japan, Australia, the U.S., the EU, ASEAN, South Korea, Tai­wan, and Canada, offering a solid comparative research analysis.

Gene-editing technology can modify and improve crop characteristics with­out inserting foreign genes, which has become an emerging and booming tech­nologies in recent years. In Chapter 8, Wen-Shen Chu of the Food Industry Research and Development Institute (FIRDI) and Pei-kan Yang of National Chengchi University engage in a comparative survey of the current regulatory status of gene-edited products among selected countries. They emphasize that excessive over-strict regulation will stifle the development of innovative bio­technology and the potential to realize the power of gene-editing technology. Innovative technologies need to be accompanied by effective management, the formulation of laws and regulations, and substantial application to maximize the innovation and transformation of the bio-industry.

In Chapter 9, Juanjuan Sun of Heibei Agricultural University examines the issues surrounding the regulation of novel food that have been raised in the EU in reaction to safety concerns regarding foods that are either made using newly developed technology or imported from a foreign country that do not have a history of consumption in a given place. The chapter analyzes how China has established a comparable system to regulate novel foods, consider­ing the specific situation in China, where novel food material and health food are closely linked, given that certain traditional materials can be used for both food and medicine. Sun presents the general evolution of novel food regulation in China, focusing on specific aspects related to the development of the food industry and the longstanding food culture.

In Chapter 10, Yuan Hung Tseng, who is a medical doctor with law degrees, examines various aspects of controversies in the EU’s novel food regulation (NFR) since its first proposal by the European Executive in 1992, through the first version promulgated in 1997, to the latest version that went into effect in 2018. Many scholars have engaged in extensive discussions, which are primar­ily focused on the content of the statutes and on the legitimacy and applicabil­ity of the NFR in regulating the food traded into the EU under international trade agreements. The chapter, by contrast, revisits regulations from the per­spective of the sociology of law and sociology; draws on three aspects of food neophobia as the framework to explore the problems of the law; and points out inherent tensions between the EU administrative tools, consumer protection, and scientific assessments.

Chapter 11, authored by Muhammad Nizam Awang and Sharifudin Md Shaarani of Islamic Science University of Malaysia, analyzes the regulatory responses to nanofood being included as part of novel food regulations in ASEAN countries by deliberating on the regulatory definitions of novel foods and market authorization procedures, including the conditions of use, labe­ling requirements, and pre-market authorization requirements. Nanotechnolo­gies have been valorized as one of the platform technologies of the twentieth century, where their resulting applications and products span electronic and electric products, energy and environment, the automotive sector, and food and agriculture. Concerns over safety of nanomaterials have progressively grown with the volume of commercialized nanofood products in the market. This has brought food safety authorities around the world to review the ade­quacy of existing regulatory frameworks to manage the risk and safety concerns posed by food cultivated, produced, processed, and packaged using nanotech­nology and nanomaterials. The chapter argues that the normative legal yard­stick established by food regulations in ASEAN is enough to capture nanofood and nanoscale substances in food based on the wide product categories under food laws, which must be based on the outcome of appropriate risk assessment and not be discriminatory against free trade with other countries.

Due to recent advances in emerging agri-food technologies, novel entities that have entered the category of “food” blur the boundaries between food and drugs and present new challenges to legal and regulatory agencies. The emer­gence of novel entities has not only provided new business opportunities and consumer choices but has also disrupted existing businesses and raised renewed concerns over safety. At the level of law and public policy, the safety of such products is determined within the framework of existing legal and regulatory categories, which might not be adequate to regulate novel entities. Further, because both goods and services increasingly travel across national borders, it is important to explore how classification systems for such goods and services are governed and the conflicts and contradictions that arise as a result.

In Chapter 12, Tomiko Yamaguchi of International Christian University sheds light on discourses surrounding the use of health foods, in particular where societal concerns over safety and expectations about the use of science and technology in making novel foods intersect with expectations of market expansion in Japan. In the past decades, food safety concerns have become cen­tral issues in Japanese society. The rapid transformation of the food and agricul­tural sector through the use of science and technology for food production and processing is of particular importance, and one arena in which societal tensions surface is the use of health foods. Health foods are met with high expectations from people in industry, both domestic and abroad, who are trying to enter the Japanese market or expand their market share, yet at the same time, such foods also raise safety concerns. It is important to understand the concerns that arise over the safety and quality of food in the wake of expectations of future market growth. This chapter conducts two important case studies and offers insight on how health foods are regulated in Japan.

In Chapter 13, Yeh-Han Wang of National Yang Ming Chiao Tung Uni­versity examines the blurred boundaries between effective health foods and ineffective drugs in food safety governance by way of a case study on how glucosamine products are marketed and regulated in Taiwan. As pointed out by the chapter, food and drugs have long been established categories, but their relationship is not necessarily a dichotomy. As the case of glucosamine prod­ucts demonstrates, the development and marketing of health food effectively redefine the boundary of food and drugs, leading to challenges in regulation. This chapter describes how the Health Food Control Act of Taiwan failed to regulate glucosamine products and highlights the coproduction of scientific knowledge from the classification and regulation of foods and drugs in and across countries and regions.

Last but not least, Chapter 14, authored by Eunjeong Ma of Pohang Univer­sity of Science and Technology, addresses how the line between food and drugs is drawn in South Korea and the mechanism of classification as a technology of governance. The chapter uses the baek shu oh case to provide for an entry point for examining the technology of food governance in South Korea and argues that the explosive expansion of the health foods market can be best under­stood as an asymmetric assemblage of post-colonial relations linking domestic and international regulatory authorities, consumer market agencies, techno- scientific research institutions, the academy, and medicinal plants.

Combined, the last three chapters compare country case studies in Taiwan, Japan, and Korea by probing governance challenges caused by blurring bound­aries between food and drugs, as well as the actions and/or interactions of con­cerned parties in trying to make use of opportunities or resolving tensions. As these chapters’ comparative studies demonstrate, emerging technologies place virtually any classification system under a stress test, because such a system is inevitably interlinked with cultural, historical, social, economic, and politi­cal circumstances, and the blurred boundaries between food and drugs have far-reaching consequences in many areas of public life, such as public policies, health food markets, and consumer perceptions.

This collaborative project received generous financial and technical support from Taiwan’s Ministry of Science and Technology, National Yang Ming Chiao Tung University, and National Tsing Hua University. We are indebted to our research assistant, I-Ching Chen, for her excellent work. Last but not least, we are indebted to Siobhan Poole and the rest of the team at Routledge for the editorial assistance and support, as well as the anonymous reviewers for their invaluable comments and guidance. It is our hope that this book will contrib­ute to the legal and policy discourse on the dynamic interactions between food safety and technology governance and beyond.