Food Safety Governance Frameworks and Regulations in the United States and China: A Comparative Analysis A DISSERTATION SUBMITTED TO THE FACULTY OF THE UNIVERSITY OF MINNESOTA BY Xiaoxi Li IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY Advisor: Dr. Joellen Feirtag July 2023 © Xiaoxi Li 2023 ALL RIGHTS RESERVED i Acknowledgements I would like to express my deepest gratitude and appreciation to the individuals who have contributed significantly to the completion of my PhD thesis. Their unwavering support, guidance, and encouragement have played a crucial role in shaping my academic journey and making this achievement possible. First and foremost, I would like to extend my heartfelt appreciation to my PhD advisor, Joellen Feirtag. Your expertise, invaluable insights, and relentless dedication to academic excellence have been instrumental in shaping the direction of my research. Your guidance and mentorship have not only enhanced my understanding of the subject matter but also fostered my growth as a researcher. I am truly grateful for the opportunities you have provided me and the trust you have placed in my abilities. I would like to express my deep gratitude to my mother, Xiu Wang, for her unwavering support, love, and encouragement throughout my academic pursuits. I would also like to acknowledge the support and understanding of my boyfriend, Zhao Zhu. Your unwavering belief in me and your willingness to listen and provide support have been a tremendous source of strength. To everyone who has played a part, big or small, in my academic journey, I extend my sincere gratitude. ii Contents List of Figures ............................................................................................................... v List of Tables ............................................................................................................... vii Chapter 1 ....................................................................................................................... 1 Introduction ................................................................................................................... 1 1.1 Analytical Framework ............................................................................................ 6 1.2 Objectives ............................................................................................................ 10 1.3 Materials and Methods ........................................................................................ 12 1.3.1 International Trade ........................................................................................ 12 1.3.2 Food Safety Governance Framework ............................................................ 12 1.3.3 Food safety issues ........................................................................................ 13 Chapter 2 ..................................................................................................................... 15 Literature Review ........................................................................................................ 15 2.1 The Evolution of Trade between China and the U.S. ........................................... 15 2. 2 Imports/Exports forecasts between China and the U.S. ...................................... 22 2.3 Food Safety Issues .............................................................................................. 26 Different types of food safety issues ....................................................................... 26 2.4 Food Safety Governance Framework .................................................................. 31 2.4.1 Food safety governance in the U.S. .............................................................. 31 2.4.2 Food safety governance in China .................................................................. 37 2.5 Food Safety Standards ........................................................................................ 44 2.5.1 What the international community is doing for food safety ............................. 44 Codex Alimentarius Commission and World Trade Organization ........................ 44 2.5.2 Global Food Safety Initiative (GFSI) .............................................................. 47 2.6 Food-borne Diseases and Surveillance ............................................................... 50 2.7 COVID-19 ............................................................................................................ 53 Chapter 3 ..................................................................................................................... 56 International Trade ...................................................................................................... 56 3.1 Introduction .......................................................................................................... 56 3.2 Trade between China and the U.S. ...................................................................... 58 iii 3.3 Agricultural trade between China and the U.S. in HS2 level ................................ 67 3.4 Agricultural trade between China and the U.S. in HS4 level ................................ 72 3.5 Comparison of the U.S and Chinese imports and exports of products selected according to HS Code(4-digit) ................................................................................... 78 3.6 Conclusion ........................................................................................................... 88 Chapter 4 ..................................................................................................................... 92 Food Safety Governance Framework ........................................................................ 92 4.1 Introduction .......................................................................................................... 92 4.2 The Evolution of Food Safety Governance Framework in China .......................... 93 4.3 The Evolution of Food Safety Governance Framework in the U.S. .................... 110 4.4 Current Food safety regulatory agencies in the U.S. .......................................... 112 4.4.1 FDA............................................................................................................. 116 4.4.2 Centre for Food Safety and Applied Nutrition (CFSAN) ............................... 117 4.4.3 USDA & FSIS .............................................................................................. 118 4.5 Duties of U.S. Food Safety Regulatory Agencies before and after FSMA .......... 120 4.6 Conclusion ......................................................................................................... 121 Chapter 5 ................................................................................................................... 124 Food Safety Regulations and Issues ....................................................................... 124 5.2 Food-borne diseases and surveillance in China................................................. 126 5.3 Food-borne diseases and surveillance in the U.S. ............................................. 127 5.4 Comparison of Food-borne diseases surveillance between China and the U.S. 128 5.5 Food safety disclosure mechanisms in China and the United States ................. 130 5.6 Foodborne disease outbreaks ........................................................................... 134 5.6.1 China .......................................................................................................... 134 5.6.2 U.S. ............................................................................................................. 137 5.7 Comparison of foodborne disease outbreaks between China and the U.S. by food vehicles ................................................................................................................... 141 5.8 Import Refusals issued by the U.S. .................................................................... 147 5.9 Import Refusals Issued by China ....................................................................... 156 5.10 Aquatic Products ............................................................................................. 159 5.10.1 SPS Notifications ...................................................................................... 159 5.10.2 Regulation ................................................................................................. 160 iv 5.10.3 Safety Issues ............................................................................................ 163 5.11 Vegetables and Fruits ...................................................................................... 169 5.12 Meat/Poultry .................................................................................................... 179 5.12.1 Regulation ................................................................................................. 179 Bacteria ............................................................................................................ 179 Drugs ............................................................................................................... 181 5.12.2 Safety issues ............................................................................................. 185 5.13 Grains/Soybean ............................................................................................... 191 5.14 Fungal Toxins .................................................................................................. 193 5.15 Conclusion ....................................................................................................... 196 Chapter 6 ................................................................................................................... 200 Education .................................................................................................................. 200 6.1 Introduction ........................................................................................................ 200 6.2 Food Science Undergraduate Program in China and the United States ............. 201 6.3 Graduation requirements ................................................................................... 208 6.4 Curriculum Comparison ..................................................................................... 210 6.4 Major Courses Comparison ............................................................................... 224 6.4.1 Food Analysis ............................................................................................. 228 6.4.2 Food Quality ................................................................................................ 234 6.5 Conclusion ......................................................................................................... 239 Chapter 7 ................................................................................................................... 241 COVID-19 ................................................................................................................... 241 7.1 Introduction ........................................................................................................ 241 7.2 Food Supply Chain ............................................................................................ 244 7.3 Food Safety ....................................................................................................... 246 7.4 Trade ................................................................................................................. 250 7.5 Conclusion ......................................................................................................... 254 Chapter 8 ................................................................................................................... 256 Conclusion ................................................................................................................ 256 References ................................................................................................................ 261 Appendix ................................................................................................................... 278 v List of Figures Figure 1.1 Schematic structure of the article and the sequence of each chapter. 6 Figure 2.1 The amount of trade between China and the United States and the change in the number of exports to each other, 2000-2018. 20 Figure 2.2 Forecasted the United States exports to China from 2018 to 2020 based on observed trade volumes from 1996 to 2018. 23 Figure 2.3 Forecasted China's exports to the United States from 2018 to 2020 based on observed trade volumes from 1996 to 2018. 24 Figure 2.4 Legislative-regulatory framework of food safety-related laws in China. 4040404040404040404040404040404040404040404040404040404040404 40 Figure 3.1 Top 10 destinations for U.S.(a) and China(b) exports based on gross trade volume in 2018. 59 Figure 3.2 Top 10 origins for U.S.(a) and China(b) exports based on gross trade volume in 2018. 61 Figure 3.3 Trade value of agricultural products(a) and its classifications(b) that China exports to the U.S., 2000 to 2018. 64 Figure 3.4 Trade value of agricultural products(a) and its classifications(b) that the U.S. Exports to China, 2000 to 2018. 66 Figure 3.5 Trade value of animal products, vegetable products, and foodstuffs exported from China to the U.S., 2000 to 2018. 68 Figure 3.6 Trade value of animal products, vegetable products, and foodstuffs exported from the U.S. to China, 2000 to 2018. 71 Figure 3.7 Trade value of HS2 Code 103 and 207 in HS4 level that China exports to the U.S., 2000 to 2018. 73 Figure 3.8 Trade value of HS2 Code 416 and 420 in HS4 level that China exports to the U.S., 2000 to 2018. 74 vi Figure 3.9 Trade value of HS2 Code 102,103, and 104 in HS2 level that the U.S. exports to China, 2000 to 2018. 76 Figure 3.10 Trade value of HS2 Code 210 and 212 in HS4 level that the U.S. exports to China, 2000 to 2018. 77 Figure 3.11 Total trade value of animal products (Section 1) between China and the United States, 2000 to 2018 (HS4 Level). 81 Figure 3.12 Production, consumption, and trade of pig meat(a) and poultry meat(b) in the United States and China in 2018. 82 Figure 3.13 Total trade value of vegetable products(Section 2) between China and the United States, 2000 to 2018 (HS4 Level). 84 Figure 3.14 Total trade value of foodstuffs (Section 4) between China and the United States, 2000 to 2018 (HS4 Level). 87 Figure 4.1 Timeline of China's food safety process, 1998 to 2009. 97 Figure 4.2 Structure of U.S. food safety regulatory agencies. 115 Figure 5.1 Number of foodborne disease outbreaks in China, 2001-2017. 136 Figure 5.2 Number of foodborne disease outbreaks by year in the U.S., 2001- 2017. 139 Figure 5.3 Import refusals by FDA, 2002- Mar 2021. 150 Figure 5.4 Import refusals related to China, by product category, 2002- Mar 2021.0000000000000000000000000000000000000000000000000000000 0 152 Figure 5.5 Import refusals about food related to China, by year, 2002- Mar 2021. 00000000000000000000000000000000000000000000000000000 0 153 Figure 5.6 Total food-related import refusals, 2002 to Mar 2021. 155 Figure 5.7 Unqualified imported food batches in China, 2009 to 2017. 158 Figure 5.8 Import refusals related to seafood from China, 2002 to Mar 2021. 167 Figure 5.9 Qualification rate of aquatic animals and main agricultural products in China, 2013 to 2017. 168 Figure 5.10 Pesticide residue index of vegetables in China, by qualification rate, 2005 to 2017. 170 vii Figure 5.11 Pesticide residue Index of fruits in China, by qualification rate, 2005 to 2017. 174 Figure 5.12 FDA import refusals related to vegetables and vegetable products, 2002 to Mar 2021. 176 Figure 5.13 FDA import refusals related to fruits, 2002 to Mar 2021. 178 Figure 5.14 Number of unqualified labels for meats imported from the U.S. at Shanghai Port, 2006 to 2012. 188 Figure 6.1 Comparison for curriculum design of Food Science Programs in China and the United States. 209 List of Tables Table 2.1 Comparison of the total annual trade volume between China and the United States and the export volume to each other, 2000-2018. 19 Table 2.2 Food safety agencies and responsibilities in the U.S 36 Table 2.3 Major food safety departments and their responsibilities in China after 2018. 43 Table 3.1 The export trade value from the U.S to China by category, and the corresponding proportion in the U.S overall export by category in the year 2017 and 2018, respectively (HS4 Level). 85 Table 3.2 The import tariffs that China imposed on the U.S. before and after the Trade War. 89 Table 4.1 The government agencies related to food and their responsibilities under the 101 Table 4.2 Responsibility of government departments involved with China food regulatory system before and after 2013. 104 Table 4.3 Responsibility of government departments Involved with China food regulatory system before and after 2018. 108 Table 4.4 Periods of food safety regulation in China. 109 viii Table 4.5 Summary for responsibility of agencies related to food safety and quality in the U.S. 119 Table 5.1 Comparison of food safety disclosure mechanisms between the U.S. and China. 133 Table 5.2 Number of foodborne disease outbreaks, illnesses, hospitalizations and death by year in the U.S., 2001-2017. 140 Table 5.3 Number and percentage of foodborne disease outbreaks, illnesses, hospitalizations, and deaths by food category in China, 2003-2017. 143 Table 5.4 Number and percentage of foodborne disease outbreaks and illnesses by food category in the U.S., 2003-2017. 146 Table 5.5 Comparison of the U.S. and China controls with respect to area of animal health concern. 183 Table 5.6 Number of meats imported from the U.S. unqualified by physical and chemical 190 Table 5.7 Limits of fungal toxins in different food categories from CAC, the U.S., and China. 194 Table 6.1 Top 15 Universities in China that offer Food Science and Technology Program undergraduate programs rated by the Chinese Ministry of Education. 204 Table 6.2 Top 15 National universities in the U.S. that offer Food Science and Technology Undergraduate Programs rated by the U.S. News & World Report. 207 Table 6.3 University requirements of Food Science Program in Michigan State University. 211 Table 6.4 General requirements before and after Fall 2021 of Food Science Program at University of Minnesota, Twin Cities. 213 Table 6.5 General basic courses of Food Science Program in South China University of Technology. 215 Table 6.6 College and major requirements of Food Science Program in Michigan State University. 217 Table 6.7 Program and sub-plan requirements of Food Science Program at the University of Minnesota, Twin Cities. 219 ix Table 6.8 Major core courses of Food Science Program in South China University of Technology. 221 Table 6.9 Training courses of Food Science Program in South China University of Technology. 223 Table 6.10 Requirements of MOE(China) and IFT(U.S) for major courses of the Food Science Program. 226 Table 6.11 Comparison of Food Analysis Course Syllabus between JiangNan University and the University of Minnesota, Twin Cities. 230 Table 6. 12 Comparison of lecture topics and labs of Food Analysis between JiangNan University and University of Minnesota, Twin Cities. 232 Table 6.13 Comparison of Food Quality course syllabus between the JiangNan University and the University of Minnesota, Twin Cities. 235 Table 6.14 Comparison of lecture topics of Food Quality between the JiangNan University and the University of Minnesota, Twin Cities. 237 Table 7.1 The FAO Food Price Index, Jan 2020 to April 2021. 253 1 Chapter 1 Introduction As the level of globalization continues to rise, residents' demand for quality of life is getting higher and higher, and in recent years, the structure of global residents' consumption of agricultural products has changed dramatically. Based on the limitation of China's domestic agricultural production resources, China's domestic agricultural production mainly focuses on ensuring sufficient food rations, and for the production of other agricultural products, it increasingly relies on the international market for regulation. With the establishment of diplomatic relations between China and the U.S. in 1979 and China's accession to the World Trade Organization (WTO) in 2001, China and the U.S. engage in large- scale agricultural trade every year and have established a stable and long-term trade cooperation relationship. Trade in agricultural products between the U.S. and China is an important part of the trade relationship between the two countries, and different natural conditions and policies can have an impact on the main products traded. However, language and cultural differences, government restrictions, and other factors make it difficult for traders, scholars, and policy makers in China and the U.S. to fully understand each other's food-related regulations. Therefore, it is of great significance to analyze the policies and comparisons between the two countries in terms of food products by collecting and cleaning up data on 2 agricultural trade between China and the United States and to derive the most traded agricultural product categories. Based on the analysis of trade data, we can narrow down the focus from a large number of food categories and identify the most important ones for subsequent analysis. Food trade is an important part of international trade, and food safety issues in food trade can easily be used as an excuse for a government to practice trade protectionism. China is constrained by its bureaucracy, financial resources, and technology, and there is a huge gap between its food safety regulatory system and that of developed countries, making China a passive recipient of food safety standards and vulnerable to restrictions on food exports. In the U.S., one of the earliest countries to manage food safety, the regulatory system is relatively mature and has reference value in the global arena. On the one hand, the U.S. political system and power setup provide adequate legal backing for food safety, and more importantly, the U.S. food safety management system and regulations have a nearly 100-year traceable history. Therefore, before analyzing the safety management policies for a specific type of food, we need to examine the overall food safety governance framework in China and the United States. The construction of a food safety regulatory system is a requirement to ensure food safety. We will conduct a comprehensive and specific review of the food safety regulatory system in China and the United States. We will mainly conduct a detailed characterization and comparative analysis of the development history, regulatory chain, regulatory model, legal system, and 3 operation mechanism of the system in China and the United States and summarize the reasons for the different regulatory measures and the significance of learning from the two countries. Based on a study of the current state of the food safety regulatory systems in China and the United States, we hope to show whether the food safety regulatory systems in both countries are functioning effectively to provide safe food for the public in both countries and even the world. Effective regulation is concerned with the design of policies, rules, and laws that are monitored thoroughly and backed up by a reliable threat of enforcement to produce the intended or expected results. Based on the literature review, we comprehensively observe the current status of product quality and safety in China and the United States, analyze the existing regulatory systems, and analyze the effectiveness of quality regulation and its causes through specific food categories, to identify the key points that need to be focused on the comparison. Based on the key points, we analyze the advantages and disadvantages of the regulatory instruments and methods of the two countries, identify the differences between the regulatory systems of China and the United States and the reasons for the differences, and try to find feasible measures for improving the product quality regulatory systems of the two countries. At the same time, traders in China and the U.S. may need to be aware of the differences in requirements and regulations for certain foods in both countries due to differences in culture, policies, and administrative provisions. By 4 comparing the import and export regulations of the major food categories traded between the two countries, we can provide informative advice for traders in both countries. Moreover, we can offer some guidance for customs inspection and public purchase by comparing the security and production of major food products traded between the two countries. Food safety problems are not necessarily the sole responsibility of regulation. Food safety is related to the degree of division of labor in the food industry, the level of progress in food technology, the size of the market players, the performance of government control, the binding force of the rule of law, and the construction of an integrity system. To identify the reasons for the differences in food safety management between the United States and China, we will also compare the education of undergraduate food science and technology programs in the two countries. In addition, since China's food science and technology program is less than 20 years old, a comparison with U.S. university programs may reveal what needs to be improved and enhanced in order to train more food scientists and engineers for the international marketplace. In closing, we will summarize some of the implications of the COVID-19 pandemic for the food production chain, supply chain, and food safety in China and the United States. The COVID-19 pandemic triggered a global public health crisis as an outbreak, with comprehensive and profound economic and social impacts around the world, and its diffuse and derivative effects are still ongoing. 5 As the impact of the epidemic deepened, loopholes in food safety and quality control in China and the United States were exposed to varying degrees in production and supply, market circulation, and import and export trade. With this background, we hope to analyze the problems that emerged in both countries in the face of public emergencies and avoid the same situation next time. The project is divided into five parts: the first part is an analysis of trade volume between China and the United States; the second part is an overall analysis of food safety governance framework; the third part is a comparison of regulations and safety issues in categories based on the classification of the most traded foods derived from the first part; the fourth part is a comparison of undergraduate education; the fifth part is the impact of COVID-19 on the food aspects of China and the United States. 6 1.1 Analytical Framework Figure1.1 Schematic structure of the article and the sequence of each chapter. 7 Chapter 1 is the introduction to the entire study. It details the background of the study, the significance of the investigation, and explains the overall layout of the whole text. Chapter 2 focuses on the background of the study, including 1. the status and outlook of US-China trade in the world 2. Theories related to food safety issues and the global impact of food safety burden 3. an overview of the U.S. and Chinese judicial systems and food safety- related laws/agencies 4. Efforts by international organizations for food safety standards 5. A brief overview of foodborne illness and regulation in the U.S. and China 6. A description of the status of Covid-19 Chapter 2 sets the stage for the subsequent research to unfold, moving on to answering the core questions from Chapter 3 onwards. Although the safety of consumers cannot be ignored by food companies, cost, profitability, and reputation are factors that are always brought up more often when companies think about their growth strategies. Therefore, when we discuss food safety management systems in two countries, the trade between them is particularly important. A country's food safety situation can greatly influence the volume of imports and exports. In addition to tariffs, food safety policies and trade volumes 8 also work against each other. Through the analysis of extensive trade data, we hope to answer the following questions: 1. Why U.S.-China trade (especially agricultural products) deserves to be studied? 2. What specific categories of agricultural products are most worthy of study? 3. Are there any particular factors that have led to the concentration of agricultural trade between the U.S. and China in certain categories? By answering these questions, we hope to find the food categories that need the most attention. Policies, standards, safety, and future trends regarding these categories are particularly important for policy makers and participants in the U.S.-China trade to examine. Chapters 4 and 5 are parallel in terms of comparison, meaning that the two chapters impact each other. Chapter 4 hopes to answer the following questions by analyzing food safety management systems in China and the United States: 1. What is the structure of the management system for food safety in China and the United States? How has it evolved? Can it be divided into comparable periods? 2. What is the scope of responsibilities and powers of food safety agencies? 9 3. What are the strengths and weaknesses of this management system? 4. How to improve the existing food safety management system and whether there is a mutual reference between the US and China? Chapter 4 divides the time for the development of food safety management systems in China and the United States, and the types of food we have chosen in Chapter 3, together as the focus of Chapter 5. Through Chapter 5, we will analyze the foodborne illness data from the United States and China with reference to the period in Chapter 4. We hope to examine whether the significant periods in Chapter 4 have had a positive or negative effect on foodborne illness by looking at changes in the data. The foodborne illness data is an indicator of the level of food safety in a country and is a useful resource for stakeholders in the import/export trade. Next, we will study the regulations, standards, and the number of rejections by customs in both countries for different food products in China and the United States based on the food categories in Chapter 3. Both of these aspects are informative for trade participants and policy makers. They can think about whether to raise or lower the standards to promote exports or protect their food companies based on the data of rejected by customs. Chapter 6 focuses on the similarities and differences between Food Science and Technology programs in Chinese and American universities. We attempt to analyze whether there are certain factors that contribute to the 10 sameness and diversity of food safety management in the two countries through this aspect of education. Chapter 7 looks at the different responses to Covid-19 in the U.S. and China and the implications for the food supply chain and safety. Chapter 8 summarizes the entire article. 1.2 Objectives Objectives 1: Based on the current status and development of production and demand for agricultural products in China and the U.S., and taking into account trends in socioeconomic, environmental, and resource factors, we will study the specific types of food products with the greatest prospects or trade volume in China and the U.S. Specific directions are provided for subsequent analysis of food safety. Objectives 2: A systematic comparative analysis of the current food safety management systems in China and the United States. The objective differences in governmental control between the two countries are examined, and an attempt is made to analyze whether the agencies that regulate food safety and production are functioning adequately. Also, by summarizing the evolution of the food safety governance framework in China and the United States, we try to identify the main problems or contradictions of safety control in both countries. 11 Objectives 3: Based on the specific categories of food selected in the previous section, we analyzed the similarities, differences, and changing trends of the regulations on specific food products in China and the United States. The effectiveness of the current regulatory provisions was inferred by combining the safety of the specific categories and the number of public health events that occurred. Objectives 4: From undergraduate food science and technology programs in China and the United States, we analyze the characteristics of food science education in the two countries with a view to providing possible references for talent cultivation and food science development in both countries. Objectives 5: By summarizing the impact of the COVID-19 pandemic on food safety in China and the United States, and by combining the previous section on the characteristics of food management in both countries, we hope to find out if there are areas that can be improved in both countries in the face of a sudden major safety event, so that they can be prepared to deal with it in the future. 12 1.3 Materials and Methods 1.3.1 International Trade The trade data between China and the U.S. from 2000 to 2018 was provided by the Base pour l’ Analyse du Commerce International (BACI) Database which is available on CEPII’s website. The data is adjusted on the base of the initial data of the United Nations Statistical Division (UN COMTRADE database). Bilateral trade flows are constantly collected at a highly detailed commodity level (6-digit Harmonized System) in the UN COMTRADE database. Harmonized System is the standard nomenclature for international trade, used by all custom services. The HS codes are used to identify goods and make statistics when customs around the world are assessing tariffs and taxes. The HS assigns specific six-digit codes for varying classifications and commodities. The latest data that we can obtain from the BACI database is up to 2018, also, we would like to examine trade data excluding policy factors, so we use the period 2000 to 2018 as the sample. The data includes information on the time of imports and exports(year), section ID, HS2, HS4, HS6, and trade values. 1.3.2 Food Safety Governance Framework Information and news on China's political system and sectoral reforms refer to the Chinese government website http://www.gov.cn/, a comprehensive platform for all departments of the Chinese State Council, as well as the people's governments of provinces, autonomous regions, and municipalities directly under 13 the Central Government to publish government information and provide online services on the Internet. The U.S. food safety department's responsibilities and jurisdictions are referenced from the official websites of the USDA (https://www.usda.gov/) and FDA (https://www.fda.gov/). The U.S. food safety management system and hierarchy are referenced from the official website of the U.S. Government Accountability Office (GAO) (https://www.gao.gov/). 1.3.3 Food safety issues For foodborne disease outbreaks in China, we had to merge data from official notifications of government agencies and from the literature because there was no consistent official data for the time frame we wanted to examine. The data of 2001 and 2002 are from the National Report of Public Health Emergencies issued annually by the China Ministry of Health. The data from 2003 to 2017 are adapted from “Surveillance of foodborne disease outbreaks in China, 2003–2017” by Li et al., 2020, Food Control, Volume 118. These data have different statistical methods and standards, which may lead to biased results. Data on foodborne disease outbreaks in the United States were obtained from the "Surveillance for Foodborne-Disease Outbreaks --- United States" published annually or every few years by the CDC. Since the CDC publishes the report in a different time interval than the one, we chose, the data we used were calculated from the report. 14 The data for products that FDA refused to import were obtained from the FDA import refusals Dashboard (https://datadashboard.fda.gov/ora/cd/imprefusals.htm). Data for products that China refused to import are from the Introduction to 2018 China Development Report on Food Safety. This report, published in collaboration with Peking University and the National Bureau of Statistics of China, provides official, but not comprehensive, data from 2009 to 2017. 15 Chapter 2 Literature Review 2.1 The Evolution of Trade between China and the U.S. China and the United States are the two most striking economies in the world today, influencing the general trend of world economic development, and the trade issue between China and the United States has long aroused widespread attention from countries around the world. In recent years, the trade pattern between China and the U.S. is based on the background of the rising overall foreign trade surplus of China and the rising overall foreign trade deficit of the U.S. The trade structure between China and the U.S. is significantly characterized by the rising trade surplus of China with the U.S. year after year. This trade pattern has naturally attracted great attention from the U.S. government, business, and academic circles, and many policy discussions and highly controversial arguments have been made (Devaland, 2009). The trade between China and the U.S. began with the re-established diplomatic relations in 1979 and signed a bilateral trade agreement. This gave a start to the rapid growth of total trade volume (imports and exports)between the two countries. U.S.-China trade was $2.45 billion in 1979(8.3% of total China trade value; 1.3% of total U.S. trade value), amounted to $42.84 billion in 1996(14.8% of total China trade value; 6.9% of total U.S. trade value), and reached $620 billion in 2018(14.7% of total China trade value; 15.6% of total U.S. 16 trade value). Since 1979, the U.S. has been China's third-largest trading partner, and in 1996 it became the second-largest trading partner. China was the twenty- fourth largest trading partner of the United States in 1980 and overtook South Korea to rise to fifth place in 1995 (UN Comtrade, 2020). Since China joined the World Trade Organization (WTO) in 2001, there was a steady increase in the trade surplus with the U.S (Chong & Li, 2019). China's accession to the WTO was of great significance for the future of the international trading system. The terms of China's accession to the WTO had served as a template for other transition economies, including Russia, that was seeking to join the WTO (Lardy, 2001). At the same time, China had played an important role in setting the agenda for multilateral trade negotiations. In 2003, China replaced Mexico as the second-largest source of imports for the U.S. One year later, China’s share of U.S. imports was 14.6%, although this proportion still fell short of Japan's 18% in the early 1990s. At the same time, the U.S. was China’s largest overseas market and second-largest source of foreign direct investment on a cumulative basis. China became the fourth largest market for U.S. goods and remained the fastest-growing major U.S. export market in 2004 (Devaland, 2009). However, since January 2018, the global economy has witnessed tons of trade disputes between the two countries when the U.S. government decided to impose safeguard tariffs on large residential washing machines, solar cells, and modules. (Chong & Li, 2019). On March 23, 2018, the Trump administration released its Section 301 investigation report, 17 proposing to impose tariffs on Chinese goods exported to the U.S., as well as restricting the mergers and acquisitions of Chinese companies in the U.S. market, and the trade war between the U.S. and China officially started (Y. Wang, 2018). Until 2019 China was the largest trade partner of the U.S. and China is now the third-largest partner just after Mexico and Canada (The Growth Lab at Harvard University, 2020). Over the decades, China’s exports to the U.S. have changed from low- value, labor-intensive products to more capital-intensive goods. China runs a trade surplus with the U.S., the EU, and Japan, which are the world’s three major economic centers. (Devaland, 2009). Since 2000, the U.S. has incurred its largest bilateral trade deficit with China ($201B in 2005). In 2018, the U.S. exported $119B to China. The main products exported from the United States to China were Planes, Helicopters, and/or Spacecraft ($15.6B), Cars ($6.86B), and Integrated Circuits ($6.45B). From 2000 to 2018, the exports of the United States to China have increased at an annualized rate of 11.87%, from $18.7B in 2000 to $119B in 2018 (Table 2.1) (UN COMTRADE, 2018). At the same time, China exported $499B to the United States. The main products exported from China to the United States were Broadcasting Equipment ($57.8B), Computers ($46.2B), and Office Machine Parts ($25B). During the 19 years, the exports of China to the United States have increased at an annualized rate of 11.03%, from $91.1B in 2000 to $499B in 2018 (UN COMTRADE, 2018). 18 From 2004 to 2014, there was an exponential increase in the volume of trade between the two countries, except for the drop relative to the previous year in 2009 (Figure 2.1). In fact, trade in the reference period increased from $221.9B to approximately $600B, representing a positive evolution of about three times the initial volume (Table 2.1). In 2009, the volume of trade between the two countries declined (Figure 2.1). The annualized changing rate in 2009 is -2.97% for the U.S. exported to China, and -12.58% for China exported to the U.S (Table 2.1). The drop in the positive momentum registered in this time was mainly due to the great recession faced by both countries in the same period, which led to the collapse of global trade, murky protectionism, and the crisis (Baldwin, 2009). Although exports and imports were affected, a positive recovery was recorded in 2010 after one year of decline. The mini-recession in spring 2016 has caused a -6.87% changing rate for the U.S. exported to China, and a -5.42% changing rate for China exported to the U.S. Because of the devaluation of the currency and raised the cost of imports, the recession has impacted the global trade for a year. 19 Table 2.1 Comparison of the total annual trade volume between China and the United States and the export volume to each other, 2000-2018. Source: UN COMTRADE Year U.S exported to China (in USD); x 1 billion Annualized changing rate China exported to the U.S (in USD); x 1 billion Annualized changing rate Total trade volume (in USD); x 1 billion 2000 18.7 19.11% 91.1 21.47% 109.8 2001 22.1 18.18% 93.8 2.96% 115.9 2002 23.9 8.14% 115 22.60% 138.9 2003 30.6 28.03% 141 22.61% 171.6 2004 38.9 27.12% 183 29.79% 221.9 2005 44.1 13.37% 223 21.86% 267.1 2006 56 26.98% 264 18.39% 320 2007 65.8 17.50% 298 12.88% 363.8 2008 74.1 12.61% 318 6.71% 392.1 2009 71.9 -2.97% 278 -12.58% 349.9 2010 92.9 29.21% 349 25.54% 441.9 2011 106 14.10% 381 9.17% 487 2012 115 8.49% 401 5.25% 516 2013 131 13.91% 419 4.49% 550 2014 136 3.82% 454 8.35% 590 2015 131 -3.68% 461 1.54% 592 2016 122 -6.87% 436 -5.42% 558 2017 133 9.02% 477 9.40% 610 2018 119 -10.53% 499 4.61% 618 20 Figure 2.1 The amount of trade between China and the United States and the change in the number of exports to each other, 2000-2018. Source: UN COMTRADE 21 In general, there were four very popular theoretical explanations in policy and academic circles for the causes of the U.S.-China trade pattern (M. Li et al., 2020). The first, and most popular, was that China's rising trade surplus with the United States was due to the artificially low exchange rate of the RMB, which led to an unnatural competitive advantage for Chinese goods in the U.S. market, resulting in a large trade surplus (J. Lau, 2010). The second theory was the savings theory, which argued that the trade imbalance between the U.S. and China was caused by the difference in savings rates between the two economies (Obstfeld & Rogoff, 2009). The third theory was the structural theory. It argued that the trade imbalance between the U.S. and China is the result of changes in the pattern of world trade. The last view, which was the one we would discuss, was that the Chinese side had a lot of policy incentives and institutional incentives in exporting to international markets, including exports to the United States, which artificially led to the entry of a large number of Chinese products into the U.S. market; on the contrary, the entry of U.S. products into the Chinese market was subject to various policy and institutional restrictions, so much so that the resistance to the entry of U.S. products into the Chinese market was very strong, resulting in the imbalance of trade between the two countries (Kumcu et al., 1995). 22 2. 2 Imports/Exports forecasts between China and the U.S. Since 2018, both the United States and China have taken various measures to restrict trade between the two countries, most notably by raising tariffs. However, the trade forecasts (Figure 2.2 & Figure 2.3) were based on a long short-term memory model (LSTM) and regardless of the impact of the trade war began in 2018 and the COVID-19 pandemic began in 2019. The figures are made using The Atlas of Economic Complexity website provided by the Growth Lab at Harvard University. The LSTM approach is a form of machine learning which utilizes a recurrent neural network. In the case of the forecasts shown below, a data time series from 1996-2018 were used as input for the model. The model is then able to learn order dependence and produce a sequence prediction. From the U.S. perspective, without the influence of the global market and policy, there will be an increase in export volume from the U.S. to China. As predicted, the U.S. will export a total of $160B products to China in 2020 (Figure 2.2). Compared to the $119B total export volume, there will be a 34.5% increase in exports to China. From China’s domestic, also neglecting any ongoing trade conflicts, the total export volume to the U.S. will rise to about $600B (Figure 2.3). The trade surpluses will increase from $380B in 2018 to $440B in 2020. There will be a 20.2% increase in exports to the U.S., compared to the $499B in 2018. 23 Figure 2.2 Forecasted the United States exports to China from 2018 to 2020 based on observed trade volumes from 1996 to 2018. Source: The Atlas of Economic Complexity 24 Figure 2.3 Forecasted China's exports to the United States from 2018 to 2020 based on observed trade volumes from 1996 to 2018. Source: The Atlas of Economic Complexity 25 Since the establishment of diplomatic relations between China and the United States, the two countries have opened their markets to each other, and the scale of trade has grown rapidly. Before the trade war, more than 50% of U.S. soybeans and more than 15% of U.S. cotton were exported to China, while imports of agricultural products from the U.S. made up for the lack of China's supply capacity (Juan Du, 2019). Agricultural products cooperation was one of the earliest areas of U.S.-China trade and were an important aspect of bilateral trade between the two countries. For a long time, China has mainly imported from the United States wellhead land-rich agricultural products, including soybeans, grains, livestock products, etc. (Juan Du, 2019). The U.S., on the other hand, imported labor-intensive agricultural products from China, including seafood, fruits, vegetables, and so on. China's agricultural trade with the U.S. was highly complementary, and the agricultural products traded between the two countries played an important role in both markets. At the same time, as the world's largest importer of agricultural products, China relied heavily on imports of agricultural products (T. Liu & Woo, 2018). For example, soybeans were very dependent on the international market, China's current demand for soybeans gap was more than 90 million tons, while the United States happened to be the world's largest producer of soybeans, production in about 100 million tons, but its consumption was limited, half of which needed to be exported (Du, 2019). 26 We found that the U.S.-China relationship presents a paradox in that, on the one hand, the two countries were interdependent, and, on the other hand, the competitive nature of the relationship seemed to be on the rise. As a result of the trade war, both countries' agricultural products have been hampered and their agricultural debt levels have increased. The ability of the U.S. and Chinese farms to repay their debts was weakening. The U.S.-China trade friction was long- standing and severe, and the underlying structural problems in both countries cannot be changed overnight. (Xiong & Wang, 2019). We will continue to discuss this issue in Chapter 3. 2.3 Food Safety Issues Different types of food safety issues Food is the most basic and important material for human survival and development, its safety is bound to become the public's greatest concern, the most direct and most realistic issue. In recent years, the widespread use of new raw materials, equipment, technologies, and techniques has led to the frequent emergence of new food safety issues. In addition, with the accelerated pace of economic globalization and trade liberalization, various chemical and biological contaminants are spreading globally with extraordinary breadth and depth. As a result, food safety is no longer a problem faced by individual countries but has crossed national boundaries to become a major issue common to human society. In recent years, food safety issues have been frequently exposed by the media, 27 causing great fear among consumers. There are many different types of food safety problems, and the main categories, in terms of causes, are as follows: food microbiology and food chemistry. Food microbiology includes food-borne diseases, food-borne parasitic diseases, food-borne pathogenic bacteria, and viruses. Food chemistry includes food additives, pesticide residues, veterinary drug residues, heavy metal contamination, and food fraud. In the analysis of data on food safety issues that we will discuss later, we will focus on food microbiology, especially foodborne disease, not only because this area has the most complete data in comparison, but also because this is the area where safety issues are most widespread and can be transmitted through international trade. Aspects of food chemistry will also be discussed in the section on food safety issues, but more in the section on food regulations. The WHO defines foodborne illnesses as infectious or toxic diseases caused by the ingestion of pathogenic factors entering the human body (WHO, 2021c). By summarizing the events of recent years in foodborne disease outbreak monitoring and reporting systems around the world, it was found that the main causative factors of foodborne diseases are pathogenic microorganisms, natural toxins, parasites, and toxic and harmful chemicals. Among the factors with clear etiology, microorganisms cause the majority of diseases, while bacterial foodborne diseases account for the major part, followed by chemical substances and toxic plants and animals. 28 Pathogenic microbial contamination, also known as biological contamination, can cause infectious poisoning or toxin-based poisoning due to bacterial proliferation in food. The microorganisms that cause this type of foodborne illness are mainly Salmonella Species, Escherichia coli, Staphylococcus aureus, Campylobacter species, Listeria monocytogenes, Enterococcus species, Lactic Acid Bacteria (LAB), etc. In some foods, due to untimely detection and backward detection technology, food materials that have been infested with pathogenic microorganisms are processed for production, resulting in food poisoning (S. Wang et al., 2007). According to the World Health Organization, the number of diarrhea cases in children under 5 years of age reaches more than 1.5 billion per year worldwide, and more than 3 million children die of diarrhea each year, more than 70% of which are caused by contamination with disease-causing microorganisms. It can be said that in both developed and developing countries, the danger of foodborne diseases cannot be taken lightly (WHO, 2021a). Foodborne hazards caused by contamination with foodborne pathogenic bacteria are one of the major food safety issues in China today, and a common challenge for countries around the world. As an important food importer for other exporting countries, China imports food from more than 170 countries and regions every year. In 2017-2019, sampling of imported food showed high rates of pathogenic contamination in meat and chilled aquatic products, mainly Listeria monocytogenes in meat and fish, Vibrio parahaemolyticus in shrimp, crab and 29 shellfish, and low rates of pathogenic contamination in dairy powder, although Cronobacter and Staphylococcus aureus were also detected (Zhao et al., 2020). In terms of foodborne illnesses caused by imported food, the United States has also made some statistics. A study of CDC data on foodborne illnesses related to imports and exports from 1996 to 2014 showed that the number of reported outbreaks related to imported foods was small but on the rise. Most of the outbreaks, especially those related to agricultural products, were associated with food imported from Latin American and Caribbean countries (Gould et al., 2017). Due to their proximity, these countries are the main sources of perishable items (e.g., fresh fruits and vegetables). Similarly, many outbreaks were associated with fish from Asia, which is consistent with data on the source of fish imports. Food problems caused by agricultural chemicals and environmental pollution are due to the massive use of agricultural chemicals such as fertilizers, pesticides, and growth regulators by some producers and growers, resulting in excessive chemical residues in agricultural products. This behavior poses a great risk to food safety at the source and endangers the personal health of consumers. In addition, environmental pollution poses a great danger to food safety. Environmental contaminants are substances that pollute the environment, including harmful gases and solid particles, heavy metals, organic toxins, pathogens, etc. These contaminants can cause varying degrees of food contamination throughout the food chain, resulting in food safety incidents. 30 Abuse of additives. Nowadays, to obtain the maximum profit, some enterprises add toxic and harmful substances in food, especially the abuse of food additives, which can cause cancer, genotoxicity, and residues in the human body, disrupting metabolism and other consequences of long-term use of food. For example, the chemical melamine was detected in the Chinese Sanlu milk powder. Melamine, which is illegally added to milk powder, can cause lifelong kidney damage to infants and children (Xiu & Klein, 2010). The proliferation of counterfeit and expired food. Counterfeit and substandard food products are a major problem in food safety and expired and spoiled food products can also be harmful to human health and life. In some poor and backward rural areas of China, due to poor food distribution networks, foods with short shelf life, such as bread and milk, are easily spoiled because they are not sold within the specified time frame. Most of the food for families in these regions does not originate from supermarkets or wholesalers like in the U.S. but from places like small food markets or home workshops that are not regulated. This poses a serious health hazard to consumers. Most of these sellers operate illegally without a license, ignore national food safety regulations and standards, and falsify their production and processing, lacking legal awareness and a sense of social responsibility. 31 2.4 Food Safety Governance Framework 2.4.1 Food safety governance in the U.S. With the advancement of economic globalization, the issue of food safety has become a global issue that is not bound by national borders. According to World Health Organization estimates, with the development of transportation and the liberalization of international food trade, the impact of food safety incidents is not the same as in the past (Xia, 2019). Comparing and understanding how the U.S. has developed a food regulatory system adapted to the needs of modern industrial society can help us better understand the issues facing the Chinese government in the area of food regulation and consider future developments. To understand the following chapters on the comparison of Chinese and U.S. regulatory agencies, we need to have a basic understanding of the roles of the various branches of government. The legislative branch of the United States consists of a bicameral Congress, which is composed of the House of Representatives and the Senate. Congress is solely responsible for passing new legislation, such as the Pure Food and Drug Act that it passed in 1906. The president, the vice president, and their executive branch make up the executive branch. The president's function is to organize the executive branch through a series of federal agencies to ensure that the laws passed are implemented and enforced. These federal agencies would be responsible for the regulation of a particular area (Sanchez, 2018). 32 In the United States, many federal bills are introduced each year by Senators or Representatives. The federal bills are referred to committees for consideration of amendments and then voted on in the House of Congress. After one house votes to pass the bill, it is sent to the other house, and after both houses pass the bill, it is sent to the President for signature. If the president does not veto the bill, or if the bill is vetoed but re-passed by 2/3 of the members of both houses, it becomes federal law. Both federal and state laws need to be consistent with the Constitution. Federal law pertains to the entire country. While states can give people more rights than federal law, states cannot be more restrictive than federal law. When federal law conflicts with state law in an attempt to restrict activity, federal law takes precedence. The law sets the basic guidelines and is enforced by the federal executive agencies in accordance with specific regulations. Once a law is passed, the agency that typically enforces the law will promulgate a series of rules that provide structure and clarity to vague or broad statutory provisions (Sanchez, 2018). Regulations are enacted by government agencies, usually to implement a law, and do not have to go through the bill process described above. For regulations, an agency is required to hold a public hearing, after which a decision is made whether to adopt, change, or reject the regulation. In general, laws are rules that treat everyone equally, while regulations only affect those who deal directly with the agency that enforces them (Zach et al., 2012). 33 In terms of food safety regulation, the United States has established a network of federal, state, and local governments that are independent and coordinated with each other. The federal government maintains a high degree of authority and independence in food safety control and does not rely on state governments. The U.S. has not only established national testing centers and laboratories but has also stationed a large number of investigators to ensure that the federal government's food safety control efforts are free from local interference. In the U.S. food safety regulatory system, agencies with regulatory functions are not allowed to participate in the trade process, thus eliminating interference from local governments in food safety control (Kaml et al., 2013). The Government Accountability Office (GAO) estimates that there are about 30 food-related laws (United States Government Accountability Office, 2017). We will narrow the discussion to make the regulatory picture clearer and easier to understand. We will discuss only some of these relevant laws by food category. Our categorization of food will inform many other decisions. The Code of Federal Regulations (CFR) contains administrative rules issued by various federal agencies. That is, general and permanent rules published in the Federal Register by departments and agencies under the federal government are codified in the CFR. These rules are organized by title, and rules are grouped by agency or statute. Agencies or departments are required to act on the relevant statutes and regulations. Each agency or department is responsible for the statute that outlines its authority and the regulations that provide meaning to that authority. 34 For example, Title 21, Food and Drugs, covers rules promulgated to implement and interpret the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 USC 301 et. seq.). Title 21 is also the primary regulatory basis for the Food and Drug Administration's (FDA) regulation of food and drugs (Sanchez, 2018). There are a number of federal agencies involved in some aspects of food and food safety. As mentioned above, the GAO has identified 16 federal agencies that administer no fewer than 30 laws related to food safety (United States Government Accountability Office, 2017). Some of these agencies and laws have only an administrative role, while others are central to food safety. Federal agencies and governments provide the framework and system for food safety management in the United States. The primary agencies involved in the food safety governance system are the Food and Drug Administration (FDA; a part of the Department of Health and Human Services, HHS) and the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) (Johnson, 2016). Just as Title 21 of the CFR describes the activities of the FDA, Title 9, animal and animal products, primarily covers FSIS compliance with the regulations, while Title 7, agriculture, is a USDA-related activity (Sanchez, 2018). The FDA is responsible for all domestic and imported foods that cross the border, including shell eggs but excluding meat and poultry (Table 2.2) (FDA, 2020a). The FD&C Act of 1938 strengthened oversight of food and drugs and increased the government's ability to enforce the law. The law has been 35 amended more than 100 times and is still in effect. The most recent and most famous amendment, the Food Safety Modernization Act (FSMA), clarifies the FDA's responsibilities even more, while expanding the FDA's authority. But the regulatory boundaries between FDA and FSIS remain very blurred. Through a series of bills, Congress authorized FSIS to inspect domestic and imported meat and poultry (excluding game meat), as well as processed egg products. These acts include: Federal Meat Inspection Act (21 USC 601 et.seq.; 9 CFR), Poultry Products Inspection Act (21 USC 451 et.seq.; 9 CFR), and Eggs Products Inspection Act (21 USC 1031 et.sep.; 9 CFR).The Center for Disease Control and Prevention (CDC), an important part of U.S. food safety, is responsible for monitoring, identifying, and investigating foodborne illnesses in cooperation with the FDA and FSIS, as well as local health departments. The CDC operated under the authority of the Public Health Service Act (42 USC 201 et. seq.). 36 Table 2. 2 Food safety agencies and responsibilities in the U.S Parent-agency Agencies Responsibilities USDA FSIS Regulates domestic and imported meat, poultry, catfish, and egg products. HHS FDA Responsible for the safety of all domestic and imported foods (except those regulated by FSIS) via CFSAN. CDC Prevents the transmission, dissemination, and spread of foodborne illness. 37 2.4.2 Food safety governance in China Food safety has been a major concern for the Chinese government and residents in recent years, especially since there are many flaws and loopholes in the current management of food safety in China. The study of food safety management issues at the legal and institutional levels is of great value to the harmonious development of the Chinese and U.S. economies. Compared to the United States and other developed countries, China's legal system for food safety management is relatively inadequate, and its enforcement system and oversight are relatively poor. We will briefly describe the current state of China's food safety management system and its problems in the following sections. Since the "reform and opening up" in 1978, China's food supply system has developed rapidly (P. Liu, 2010). Food industry structure and supply categories are becoming more and more complete. With the acceleration of industrialization, the food industry is expanding in scale and supply, however, the rule of law and order is not yet sound. This has also led to excessive pesticide and veterinary drug residues, illegal additions, production and sale of counterfeit and other problems began to appear. In particular, the 2008 "Sanlu Milk Powder" incident led China to take a series of major measures in food safety management. In 2009, China enacted its first food safety law, the Food Safety Law of the People's Republic of China. The current food safety management system in China is based on laws, regulations, departmental rules, and standard codes based on this Food Safety Law. In 2015, the Food Safety Law was revised 38 and is considered to be the strictest food safety law in China's history. China's food safety regulatory mechanism has also been adjusted five times since 2000, with the most significant adjustment in 2018 (Hu, 2018). For comparison with the U.S., we will then describe the Chinese legislative system in general. China has a system of people's congresses in accordance with the Constitution of the People's Republic of China, and the National People's Congress is the highest authority of the nation. The National People's Congress mainly exercises legislative power and elects the head of the country (the President), the executive (the State Council), and the judiciary (the Supreme People's Court). The Standing Committee of the National People's Congress, a permanent part of the National People's Congress, exercises the functions of the national legislature when the National People's Congress is not in session. The State Council is the highest executive branch in China and the executive organ of the National People's Congress. In China's legal system, the Constitution has the highest legal force, and laws are second only to the Constitution but higher than administrative regulations. Amendments to the Constitution require a majority of at least 2/3 of the National People's Congress to adopt, while laws require a half majority to adopt. Below we will illustrate the hierarchy of legal provisions in China by giving examples (Figure 2.4). The Food Safety Law (revised version 2018) is second only to the Constitution in China's legislative hierarchy as a law promulgated by the Standing Committee of the National People's Congress (Guo et al., 2012). 39 The implementing regulations of the Food Safety Law issued by the State Council are administrative regulations and are lower in the legal hierarchy than the Food Safety Law. The latest Implementation Regulation of the Food Safety Law was adopted in 2019 and came into effect on December 1, 2019. Local governments above the county level are allowed to issue local regulations (lower than regulations) to accommodate different regional management needs. At the bottom level, the administrative departments under the State Council have issued a number of department rules, mainly dealing with supporting measures for food safety supervision and management within the scope of each department's responsibilities. An example is the Measures for the Administration of Food Production Licensing issued in 2015 by the China Food and Drug Administration(CFDA). 40 Figure 2.4 Legislative-regulatory framework of food safety-related laws in China. 41 To strengthen the governance of food safety issues, the 2018 amendments to the Food Safety Law restructured the national institutional mechanism for food safety regulation. For food safety standards, the State Administration for Market Regulation (SAMR), National Health Commission (NHC), and Ministry of Agriculture and Rural Affairs(MARA) are jointly responsible for the development of food safety standards. For example, the standards for pesticides, including maximum residue levels (MRLs), are jointly set by NHC and MARA (Guo et al., 2019). The new food safety law requires food safety standards to comply with food hygiene standards, food inspection and quarantine standards, and technical standards for food safety control and management, which means clear regulations and tolerances for individual hazardous substances in food, strict control of the food to be inspected, and the development of a rational and orderly process (Y. Wu & Chen, 2018). After 2018, SAMR, as a department that integrates several food-related agencies such as CFDA and AQSIQ, is responsible for a number of tasks including the development of food safety-related regulations and standards, the registration of market entities, the enforcement of market supervision, and the regulation and coordination of food from production to consumption (Table 2.3) (Kang, 2019). The Chinese Center for Disease Control and Prevention (CDC), a unit directly under the NHC, is responsible for measuring and evaluating public health emergencies, participating in national public health preparedness, and providing technical support for the development of public health laws and 42 regulations, etc. MARA, formerly the Ministry of Agriculture, is responsible for drafting laws and regulations related to agricultural products, participating in the development of agricultural import and export policies, and monitoring the quality and safety of agricultural products. MARA is also responsible for monitoring and managing the quality and safety of agricultural products. 43 Table 2.3 Major food safety departments and their responsibilities in China after 2018. Departments Responsibilities State Administration for Market Regulation (SAMR) ● Regulation of food production, distribution, and consumption ● Food safety and quality control ● Licensing Development of food safety standards National Health Commission (NHC) ● Food safety risk management ● Monitoring and response to public health emergencies Ministry of Agriculture and Rural Affairs (MARA) ● Regulation of production, distribution, and consumption of agricultural products ● Management of livestock slaughter 44 Prior to the revision of the new food safety law, China's food safety regulatory system was based on a multi-sectoral model, with each sector having a separate segment. This led to difficulties in distinguishing the responsibilities of each regulatory department, and in dealing with problems, they passed the buck to each other and were prone to gaps in regulatory work. At the same time, China's food safety risk monitoring has always been problematic due to the unreasonable distribution of responsibility for the main body of risk assessment and inadequate disclosure of information. The new food safety law addresses these issues by reforming the regulatory agencies and introducing an "information sharing mechanism". However, at this stage, institutional reforms are too frequent, and the progress of institutional integration is very slow, which affects the exercise of regulatory functions. In a short period of time, the impact of the new food safety law is still difficult to be seen (L. Wu & Liu, 2015). 2.5 Food Safety Standards 2.5.1 What the international community is doing for food safety Codex Alimentarius Commission and World Trade Organization Global economic integration has brought the benefits of interoperability and mutual benefit to countries around the world and has also done a great deal for food safety in the international community. The Food and Agriculture Organization of the United Nations (FAO) was established in 1945, and the World Health Organization (WHO), established in 1948, joined forces in 1961 to 45 establish the International Codex Alimentarius Commission (CAC) (Hasmin et al., 2020). The primary role of these international organizations is to coordinate food standards and food safety efforts among governments. By establishing an internationally harmonized system of food standards, these organizations hope to achieve the goal of preventing the spread of foodborne diseases through international food trade to protect consumers and promote fairness in food trade. Relying on the work of its members, the CAC has become the world's premier international food standards-setting body, operating in a transparent and inclusive manner that is based on the latest and best expert scientific advice and consensus. The World Trade Organization, established in 1995 as an international organization like the CAC, also contributes to international food safety. The Uruguayan multilateral trade negotiations, held from 1986-1994 by the WTO's predecessor, the General Agreement on Tariffs and Trade (GATT), discussed trade in products, including trade in food, and resulted in two formal food-related agreements, the Agreement on Technical Barriers to Trade of The World Trade Organization (WTO/TBT Agreement) and the Agreement on the Application of Sanitary and Phytosanitary Measures (WTO/SPS Agreement) (M. M. Du, 2010). Under the WTO/SPS Agreement, member countries are required to make efforts to control the invasion of pests and diseases, to control additives and contaminants in food, beverages and feed, and to prevent or limit the spread of plagues, etc. The WTO/SPS Agreement also provides that member countries 46 have the right to take sanitary and phytosanitary measures necessary to protect human, animal or plant life or health, provided that a risk assessment is conducted and that these measures must not be disguised as trade-restrictive measures (Neeliah & Goburdhun, 2010). Although the WTO/SPS provides these conditions mentioned above, there are still some problems in the specific operation of the process. The agreement does not specify whether the scientific basis of the criteria is based on the basis proposed by the importing country or the basis proposed by the exporting country, thus leading to controversy in practice. At the same time, the international standards used by members are not mandatory, in other words, even if international standards exist, if members have a scientific basis to prove, or after appropriate risk assessment to prove that the domestic standards they use can achieve a higher level of protection than the international standards, they can use their domestic standards to provide sanitary and phytosanitary measures (Obstfeld & Rogoff, 2009). For example, the decades-long dispute between the European Union and the United States over import restrictions on hormone steaks is related to the scientific basis. As human awareness of food safety hazards has increased, international organizations such as the FAO, WHO and WTO have held many meetings of experts to discuss issues related to food safety. In short, countries around the world are putting the regulation and management of food safety on the agenda in order to protect human health and to protect the economic interests of their 47 respective countries. The protection of the environment, the health and safety of humans, animals and plants, and the rights and interests of consumers are the responsibility of national and regional governments around the world, as well as the rights of member countries under the principles of the WTO. 2.5.2 Global Food Safety Initiative (GFSI) There are currently four main stakeholders in international food safety management standards: national governments, the International Organization for Standardization (ISO), CAC, and retailer organizations. Governments are the regulatory bodies, retailers represent customers and consumers, and ISO and CAC are international organizations, with ISO being a non-governmental organization. Government requirements are often in the form of laws and regulations, most notably in the U.S. In 2013, the FDA introduced the Foreign Supplier Verification Programs (FSVP) to implement the FDA Food Safety Modernization Act (FSMA) to require U.S. food importers to verify and ensure that food suppliers meet U.S. food safety and sanitation requirements. In certain circumstances (e.g., when the food is a safety risk or when expedited customs clearance is desired) the food supplier is required to obtain certification from a third-party auditor (FDA, 2020c). In 2000, CEOs of global food companies gathered at the Consumer Goods Forum to argue that consumer trust needs to be strengthened and maintained through a secure supply chain. To achieve this goal, the Global Food 48 Safety Initiative (GFSI) was created to reduce duplication of audits throughout the supply chain by integrating food safety standards. For example, different requirements from different retailers, incompatible systems, extensive documentation, and the need for repeated and frequent certification audits placed a heavy burden on food suppliers and manufacturers, resulting in a lack of efficiency and high costs throughout the food supply chain (Crandall et al., 2017). GFSI thus set out to develop a model for determining equivalence among existing food safety programs while maintaining market flexibility and choice. The GFSI Guidance document itself is not a food safety standard, nor is GFSI involved in certification or accreditation activities. GFSI proposes GFSI standards based on International Food Standard (IFS), ISO Standards and others. By implementing its certification standard system, which has been recognized by members of the Consumer Goods Forum (major global food manufacturers, retailers and foodservice companies, etc.), this standard will become the mainstream system for food safety certification and will have a huge impact on the future of the international food safety system (Crandall et al., 2017). This benchmarking model, using input from food safety experts from around the world, defines the processes through which food safety programs can achieve GFSI accreditation. In November 2015, the China HACCP certification system achieved GFSI Technical Equivalence (GFSI, 2021). On August 13, 2018, the GFSI Board of Directors announced in Paris that the USDA 49 Harmonized GAP Plus+ certification program has been acknowledged as equivalent to the GSFI Technical Equivalence Requirements. The GFSI standard for the U.S. market was introduced in 2008. At that time, Walmart wanted its suppliers and supply chain to be certified to the GFSI standard, and this approach has influenced many food-related companies. Initially, the GFSI standard was implemented in the food industry, but now it has been expanded to include manufacturing, transportation, packaging and many other areas (GFSI, 2021). Currently, GFSI standards are widely accepted in the U.S. market, including Wal-Mart, McDonald's, Kraft, Heinz, Tyson and other retailers and food manufacturers of a multinational nature, have participated in and accepted the GFSI benchmark standards. On November 7, 2011, China Certification & Accreditation Institute (CCAI) signed a Memorandum of Understanding with GFSI, opening the door to cooperation between the two parties. To date, there are 11 major food safety standard systems worldwide, including IFS (International Food Standard, Germany and France), BRC (Global Standard for Food Safety, UK), SQF (Quality and Safety, USA), DUTCHHACCP (Netherlands), FSSC 22000, and GLOBAL GAP, etc. GFSI has recognized them. The majority of Chinese food suppliers only have ISO, GMP, and HACCP certifications (Unnevehr & Hoffmann, 2015). This means that if GFSI is implemented in China, almost all domestic food suppliers will have to be certified by retailers or they will not be able to enter these retail outlets. 50 2.6 Food-borne Diseases and Surveillance Since foodborne pathogens can infect humans through the food chain, antimicrobial drug abuse also increases the risk of dispersal of drug-resistant genes. Currently, there is no systematic and comprehensive official surveillance of foodborne pathogenic bacteria and their drug resistance in the food chain in China, and few relevant studies have been reported. In contrast, the U.S. has been monitoring foodborne pathogens in the food chain since 1996 through the National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS) since 1996 to monitor the drug resistance of isolates from animal food (mainly meat), food animals, and human sources in the United States (CDC, 2020d). Of the 190,000 pathogenic strains counted by NARMS from 1996 to 2016, 29% originated from patients and 71% from animals and their products (X. Wang et al., 2019). Among the animal-derived strains, the proportions of different animals were chicken (41%), cattle (13%), turkey (9%), and pigs (8%). The highest detection rate in both animal samples and sick patient samples was Salmonella (45% and 66%, respectively), and the highest detection rate in livestock and poultry meat samples was Enterococcus spp. (42%), indicating that Salmonella is the main foodborne pathogen caused or carried by animals and humans in the United States. The data from China on human-derived pathogenic bacteria in 2016 showed that pathogenic Escherichia coli and Staphylococcus aureus were predominant. 51 The FDA began forming and operating the Director, Coordinated Outbreak Response & Evaluation (CORE). Network in August 2011, which brings together a full-time team of professionals in medicine, public health, and science to continuously seek out potential outbreaks in the United States, investigate them, and develop policies and guidance strategies to prevent similar outbreaks in the future (FDA, 2020d). The CORE Network is a new approach to monitoring, response, and post-response to foodborne outbreaks that the FDA is specifically responding to. In the past, once an outbreak occurred, the FDA assembled a response team on an ad interim basis, and once the outbreak was handled, these personnel returned to their usual duties; with the establishment of CORE Network, there is a dedicated team responsible for all aspects of the investigation from signal to response, and this new structure speeds up the response and ensures continuity and standardization of the handling process. The sources of statistical data on foodborne diseases in China are mainly statutory reports, outbreak investigations, sentinel surveillance, laboratory surveillance, and death certificates. Active surveillance systems are usually based on active laboratory surveillance, which requires the collection of clinical samples from all patients with certain diseases (e.g., diarrhea) for testing of certain pathogens, combined with related epidemiological studies. Passive surveillance consists of three interrelated and independent surveillance systems: clinical case reports, laboratory surveillance reports, and outbreak investigation report. In 2010, China began to implement a risk assessment program for food 52 safety, expanding to 312 medical institutions in 31 provinces (autonomous regions and municipalities directly under the central government) and even the Xinjiang Construction Corps (W. Li et al., 2020). Currently, foodborne disease surveillance systems in developed countries such as the United States are relatively well developed, whereas China previously only included reporting of food poisoning in its reporting system for public health emergencies. Based on the experience of developed countries, the China National Center for Food Safety Risk Assessment (CFSA) began to establish a foodborne disease surveillance network in 2011, using a nationwide network of sentinel hospitals to achieve a two-pronged prevention and control strategy of "finding food by disease" and "finding food by food (CFSA, 2021). The surveillance system can not only identify the biological specimens of patients provided by the sentinel hospitals, but also analyze the clustering of cases caused by the same food contamination and trace the pathogen of food safety incidents. However, China's foodborne disease surveillance is still in its infancy due to insufficient communication between institutions, lack of timely information sharing, and relatively chaotic management. Another network associated with foodborne outbreak surveillance is the international PulseNet, a comprehensive network of laboratories that includes more than 120 laboratories from more than 80 countries and regions. PulseNet participants use Pulsed-field Gel Electrophoresis (PFGE) to standardize molecular typing or "fingerprinting" of bacteria causing foodborne illness. 53 PulseNet China will take time to apply PulseNet to surveillance because of the inadequate database of foodborne pathogens and the level of laboratory development of PFEG (CDC, 2019b). In parallel with the development of PulseNet, the CDC established the Foodborne Diseases Active Surveillance Network (FoodNet) with 10 state health departments, FSIS, and FDA in July 1995 (CDC, 2019a). The goals of FoodNet include: determining the scope and extent of foodborne diseases; monitoring the epidemiological trends of certain foodborne diseases; analyzing the relationship between diseases and specific foods or production and marketing; interrupting pathogen transmission during outbreaks; and developing and evaluating the effectiveness of foodborne disease interventions. 2.7 COVID-19 The novel coronavirus SARS-CoV-2 (Covid-19) has cast a shadow over the world since 2019 as a virus that can spread rapidly through human-to-human transmission in the population (Henry, 2020). People infected with the Covid-19 may be asymptomatic but still contagious, or have flu-like symptoms such as coughing, sneezing and fever, and in severe cases, may have difficulty breathing or even be life-threatening. So far, there is no better way to stop the spread of Covid-19 than isolation, and governments are trying to reduce the number of infections by expecting people to go out less and wear masks. The COVID-19 pandemic has put tremendous pressure on public health systems around the 54 world, and various countries around the globe have responded. The epidemic will result in significant human losses. The strenuous global effort to contain the spread of the epidemic will have a correspondingly heavy economic cost. As a result of the spread of Covid-19, people in various countries have become concerned about food shortages. Supermarkets in all countries are in a rush to buy. Uncertainty about food supplies may prompt government policymakers to adopt trade restrictions to protect national food security. Meanwhile, because of the increasing number of Covid-19 patients, many governments have had to suspend the import and export of some agricultural products, which in turn has affected the global prices of agricultural products (Rizou et al., 2020). On October 17, 2020, the China CDC released news that they had detected and isolated live viruses from positive samples of imported frozen cod out packs handled by workers in Qingdao, Shandong Province (China CDC, 2021). This is the first time that the Covid-19 virus has been confirmed outside the laboratory to survive for a longer period of time on the outer packaging of an item under the special conditions of cold chain transport, suggesting the possibility of cross-border importation of new coronaviruses in cold chain items over long distances. This finding suggests that, while preventing the importation of infected persons from abroad, attention needs to be paid to the risk of virus importation in cold-chain items contaminated with the virus outside the country. Existing studies 55 and control practices indicate that Covid-19 is not a foodborne disease and no infection has been found to be caused by ingestion of food. Nonetheless, there is still a need to rethink the current food supply chain and to strengthen the disinfection and safety training of supply chain workers for Covid-19. 56 Chapter 3 International Trade 3.1 Introduction From November 10 to 15, 1999, a delegation of the Chinese government and a delegation of the United States government negotiated in Beijing on China's accession to the World Trade Organization (WTO) (Pang et al., 2002). On November 15, the two sides signed a bilateral agreement between the government of the People's Republic of China and the government of the United States of America on China's accession to the WTO. The signing of the above agreement between China and the United States is a win-win outcome, which accelerates the process of China's accession to the WTO, facilitates the comprehensive development of China-US economic and trade cooperation, contributes to the stability and development of China-US relations, and injects new vitality into the development and prosperity of the world economy. With the deepening of economic globalization, global agriculture has been transformed from traditional agriculture to modern agriculture and has gained new development based on this. Driven by scientific and technological progress and market competition, the form of the international division of labor has also undergone significant changes. However, in March 2018, the U.S. announced tariff increases on all imports of steel and aluminum, including EU and North American Free Trade Agreement (NAFTA) countries (Bollen & Rojas-Romagosa, 57 2018). At the same time, in the new version of the U.S. National Security Strategy released in early 2018, China was defined as a "strategic competitor" for the first time, marking a new phase in U.S. policy toward China. These initiatives have led the EU, NAFTA countries, and China to start imposing tariffs on goods from the US. Trade disputes in which retaliatory tariffs are used as a deterrent can result in welfare losses for both countries and their associated countries. Rosyadi and Widodo argue that a 45% increase in import tariffs by both the Trump administration and the Chinese government would result in a lose-lose situation. The GDP of China and the U.S. would fall by 1.22 percent and 5.4 percent, respectively (Rosyadi & Widodo, 2018). Bollen and Romagosa also argue that such trade-restrictive behavior would be a loss for all countries involved in the trade war (2018). According to the WTO 2019 report, the five largest traders accounted for 37 percent of the world's total trading volume in 2018. Among them, China as the leading merchandise trade exported $2.7 trillion and imported $1.61 trillion in 2018. The United States, the leading trader in commercial services, exported $1.44 trillion in total and imported $2.41 trillion in total (WTO, 2020). The outbreak of trade disputes has undoubtedly caused a clear impact on international trade. In 2018 world merchandise trade grew by 3%, slightly higher than GDP growth, but lower than the 4.6% growth in 2017. The decrease in the volume of growth is mainly due to the gradual increase in trade restrictions 58 between countries. According to the records, import restrictions in 2017 and 2018 reached an unprecedented high of $588.3 billion and $339.5 billion, respectively. The Director General of the WTO believes that the problem of trade tensions must be resolved if we want the volume of trade to pick up (WTO, 2021). 3.2 Trade between China and the U.S. Currently, the COVID-19 pandemic has triggered trade restrictions and airline embargoes that directly undermine the international free trade system. At the same time, it has produced a serious trade disruption effect, causing a significant contraction in global demand for trade in goods and services. Therefore, we will focus on analyzing the international trade situation before the pandemic in this section. In 2018, China's total exports to the U.S. were $455 billion. The main products that China exported to the U.S. are broadcasting equipment ($57.8B), computers ($46.2B), and office machine parts ($25B). The U.S. exports to China were $120 billion mainly included planes, helicopters, and/or spacecraft ($15.6B), cars ($6.86B), and integrated circuits ($6.45B) (UN COMTRADE). From Figure 3.1 we can find that in 2018, China was the third-largest export destination of the United States after Canada and Mexico, accounting for 7.27% of total U.S. exports. Canada, Mexico, China, Japan, and the United Kingdom, accounted for nearly half of total U.S. exports. Meanwhile, the U.S. was China's top export destination, accounting for 18.41 percent of its total exports. 59 Figure 3.1 Top 10 destinations for U.S.(a) and China(b) exports based on gross trade volume in 2018. (a) (b) 60 From Figure 3.2, in contrast to the export data, China is the number one source of U.S. imports, accounting for 19.22% of total U.S. imports. China, Mexico, Canada, and Japan combined, account for more than half of U.S. imports. And the U.S. is China's fourth-largest source of imports, behind South Korea, Japan, and Taiwan. 61 Figure 3.2 Top 10 origins for U.S.(a) and China(b) exports based on gross trade volume in 2018. (a) (b) 62 Both China and the United States are major agricultural producers and traders. Before the start of the trade war, the United States was the third-largest export market for Chinese agricultural products (10.37% of China's total agricultural exports to the United States in 2017) and the top source of imports (17.21% of China's total agricultural imports from the United States in 2017). （UN COMTRADE). The main body of U.S. agricultural operations is mainly farming of different sizes, with a high degree of large-scale production, with an average farm size of about 179.68 hm² in 2017 and a commercialization rate of agricultural products reaching 100%. All products produced by farmers are sold to the public, and most of them are exported in addition to meeting the domestic market demand. (Xiong & Wang, 2019). Meanwhile, China is the second-largest export market for U.S. agricultural products (13.50% of total U.S. agricultural exports to China in 2017) and the third-largest source of imports (4.27% of total U.S. agricultural imports to China in 2017) (UN COMTRADE). This shows the importance of agricultural products in the U.S.-China trade. In this section, we classify agricultural products in international trade into four categories based on HS codes, which are animal products (section ID: 1), vegetable products (section ID: 2), animal and vegetable biproducts(section ID: 3), and foodstuffs(section ID: 4). As can be clearly seen from Figure 3.3, the overall trend of China's exports to the United States from 2000 to 2018 is up. Except for a brief decline in 2008 and 2009 due to the economic crisis, the rest of the years have remained basically stable and upward. Among the four categories 63 of agricultural products, foodstuffs occupy the largest share. animal and vegetable biproducts are the smallest export volume and have not changed significantly for almost 20 years. Therefore, in the later analysis, we will focus on animal products, vegetable products, and foodstuffs. 64 Agricultural Products that China Exports to the U.S. Figure 3.3 Trade value of agricultural products(a) and its classifications(b) that China exports to the U.S., 2000 to 2018. (a) (b) Four Classifications of Agricultural Products that China Exports to the U.S. 65 For U.S. exports to China, even during the economic crisis from 2007 to 2008, the volume of exports was still up (Figure 3.4). Due to the trade war, in 2018, the export volume of vegetable products fell to the level of 2008. Although in terms of total volume, China exports more to the US than the US exports to China, the US exports more to China in terms of agricultural products alone. We can find that the unit of the trade value of U.S. agricultural products exported to China is 1e10, which is larger than that of U.S. imports from China(1e9). Among the four categories of agricultural products, the export volume of vegetable products is significantly higher than the other categories, at the same time, because of the 1e10 unit, we will also focus on the analysis of animal products, vegetable products, and foodstuffs in the section on U.S. exports to China. 66 Figure 3.4 Trade value of agricultural products(a) and its classifications(b) that the U.S. Exports to China, 2000 to 2018. Agricultural Products that the U.S. Exports to China (a) Four Classifications of Agricultural Products that the U.S. Exports to China (b) 67 3.3 Agricultural trade between China and the U.S. in HS2 level Based on the above analysis of the four categories of agricultural products in the U.S.-China trade, we conclude that from 2000 to 2018, the most exported agricultural products from China to the U.S. are animals, vegetables, and foodstuffs. Next, we will analyze these three categories one by one to pinpoint the specific types of foods we want to explore. From figure 3.5, we can see that among animal products, 103(fish and crustaceans, mollusks, and other aquatic invertebrates) have the largest total exports, and among vegetable products, 207(vegetables and certain roots and tubers; edible) has the largest total exports. For foodstuffs, since the unit of trade value is 1e9, we choose two with large trade volumes, 416(meat, fish or crustaceans, mollusks, or other aquatic invertebrates; preparations thereof) and 420 (preparations of vegetables, fruit, nuts or other parts of plants). The specific explanation of the HS Code is shown in Appendix Table 2.1 and Table 2.2. 68 Figure 3.5 Trade value of animal products, vegetable products, and foodstuffs in HS2 level exported from China to the U.S., 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS2 stands for the two digits after the first digit (section number) in the HS code. For example, the first digit in HS2 ID 101 means it belongs to section 1(Animal Products). 69 According to Figure 3.6, the three categories of animal products that the US exported the most to China are 102(meat and edible meat offal), 103(fish and crustaceans, mollusks and other aquatic invertebrates), and 104(dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included). While the volume of 104 exports is not significantly higher than other categories, based on our desire to examine the food safety aspects of dairy products, we still include it as a priority category for study. In the section of vegetable products, the export volume of 212(oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit, industrial or medicinal plants; straw and fodder) is significantly higher than all other categories. Also, because the unit of the graph of vegetable products is 1e10, 210(cereals) does not look like a lot in this section, but the trade value of 210 is greater than the other subcategories compared to the categories in animal products and foodstuffs. Therefore, we also selected 210 as a category for further study. For the foodstuffs section, the export volume of 423(food industries, residues and wastes thereof; prepared animal fodder) is also clearly the highest. Since the correlation between 423 and food safety is small compared to the other categories, we will select only 102,103,104, 210, and 212 for more study. For each of these selected categories, they all follow roughly the same trend as the agricultural products that the U.S. exports to China (Figure 3.4). That is, they all had a downward trend in 2008 and had a severe decline in 2018 because of policy effects. This suggests 70 that these categories are not only the largest trade value of agricultural products that the U.S. exports to China, but also the most affected by the policy. 71 Figure 3.6 Trade value of animal products, vegetable products, and foodstuffs in HS2 level exported from the U.S. to China, 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS2 stands for the two digits after the first digit (section number) in the HS code. For example, the first digit in HS2 ID 101 means it belongs to section 1(Animal Products). 72 3.4 Agricultural trade between China and the U.S. in HS4 level The HS4 level is the next step in subdividing the categories we chose for the HS2 level. We wanted to distinguish between the HS4 level categories to determine if there were specific categories that we needed to pay extra attention to in terms of food safety in international trade. From Figure 3.7 and 3.8 we find that HS4 ID 10304(fish fillets), 20712(dried vegetables), 41605(processed crustaceans),41604(processed fish),42008(other processed fruits and nuts),42009(fruit juice) have higher export volumes than the other classifications. Except for 10304, the export volume of the other five categories has shown an increasing trend in the past three years. 73 Figure 3.7 Trade value of HS2 Code 103 and 207 in HS4 level that China exports to the U.S., 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS4 stands for the two digits after the first three digits (section number & HS2) in the HS code. For example, the first digit in HS4 ID 10301 means it belongs to section 1(Animal Products), the second and third digit means it belongs to HS2 03(fish and crustaceans, mollusks and other aquatic invertebrates). 74 Figure 3.8 Trade value of HS2 Code 416 and 420 in HS4 level that China exports to the U.S., 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS4 stands for the two digits after the first three digits (section number & HS2) in the HS code. For example, the first digit in HS4 ID 41605 means it belongs to section 4(Foodstuffs), the second and third digit means it belongs to HS2 16(meat, fish or crustaceans, mollusks, or other aquatic invertebrates). 75 Figure 3.9 and 3.10 show the trade value of U.S. exports to China at a HS4 level. From these two figures we can find that HS4 Codes 10203(pig meat), 10207(poultry meat), 10303(non-fillet frozen fish), 10404(whey), 21001(wheat), 21005(corn), 21007(sorghum), and 21201(soybeans) have a higher trade volume. Of these, whey, wheat, corn, sorghum, and soybeans are the most affected by policy and tariffs. The amount of U.S. exportation to China in these categories plummeted in 2018 to levels seen a decade ago. 76 Figure 3.9 Trade value of HS2 Code 102,103, and 104 in HS4 level that the U.S. exports to China, 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS4 stands for the two digits after the first three digits (section number & HS2) in the HS code. 77 Figure 3.10 Trade value of HS2 Code 210 and 212 in HS4 level that the U.S. exports to China, 2000 to 2018. ** Harmonized System (HS) is an international nomenclature used to classify products and is a six-digit code system. HS4 stands for the two digits after the first three digits (section number & HS2) in the HS code. 78 3.5 Comparison of the U.S and Chinese imports and exports of products selected according to HS Code(4-digit) According to the previous section, we have selected some categories with the largest amounts according to the transaction amounts of US-China trade (HS4 level). In this section, we will analyze these selected categories specifically. From Figure 3.11, 3.13, we can see that in the two sections of animal products and vegetable products, there are 5 HS4 level categories each that we have selected before. Figure 3.14, foodstuffs, has four of them. In Figure 3.11, both the U.S. and China have a very large import and export trade in fish products. The amount of non-fillet frozen fish exported from the United States to China is roughly four times the amount exported from China to the United States. The amount of fish fillets exported from China to the U.S. is 36 times the amount imported from the U.S. Since 2000, China's fish trade has been on an increasing trend. In terms of fish imports, Vietnam (64.1%) was the largest source of fish imports to China in 2018, followed by the United States (9.47%) and Canada (5.05%) (UN COMTRADE) The United States, the world's top fish importer, and China and Chile were the two largest sources. (UN COMTRADE) In the last two decades, the total amount of world aquaculture has been rising in order to achieve the goal of sustainable development, while the total amount of marine capture has been maintained at 80 million tons (FAO, 2021c). According to FAO, the U.S. domestic fishery is dominated by marine capture, 79 while China's fishery is dominated by marine and inland aquaculture (FAO, 2021b). As a result, the vast majority of U.S. fish consumption is dependent on imports. Leading products such as shrimp, cuttlefish, squid, mollusks and shellfish, which are suitable for production in Chinese water conditions, have formed the mainstay of China's aquatic products trade with the United States. The U.S. relies on the vast coastal shelf to produce and export cod, salmon, flounder and crayfish, among other aquatic products. That is, China and the U.S. carry out trade in aquatic products by giving full play to the comparative advantages of their biological resources (P. Wang et al., 2020). For both pork and chicken, U.S. exports to China are much higher than imports from China (Figure 3.11). According to Figure 3.12, we can see that the U.S. is a net exporter of chicken and pork, and China has a trade surplus in chicken. Looking at the consumption of meat in China and the U.S. during the same period, Chinese consumers are more inclined to consume pork. Both the U.S. and China are largely self-sufficient in chicken and pork. In 2018, the U.S. was the world's top pork exporter (15.8%) and second-largest chicken exporter (13.4%), while China was the third-largest pork importer (7.34%) and eighth- largest chicken importer (3.9%) (UN COMTRADE). The U.S. pork production costs are significantly lower than China's due to high mechanization levels, low feed costs, and large arable land areas. Pork trade between China and the U.S. is significantly affected by bilateral pork trade policies and hog epidemic, and the trade volume and trade value fluctuate 80 drastically, which is not conducive to the comparative advantages and resource endowment of pork production in both countries and is not conducive to stabilizing the expectations of pork production and consumption in both countries. In the long run, the market potential of pork trade between China and the United States is great. According to Figure 3.11, it can be found that whey trade between China and the U.S. is mainly characterized by China's imports from the U.S. In 2018, China was the largest whey importer to the U.S., with a trade value of 185 M. Meanwhile, 31.4% of China's whey imports came from the U.S (UN COMTRADE). Whey is a byproduct of the production of cheese or casein, and due to consumption and dietary habits, China's cheese production is extremely low, making it largely dependent on imports. Currently, most of the whey powder imported from the U.S. is used for feed, so it has little impact on the production of infant formula in China. 81 Figure 3.11 Total trade value of animal products (Section 1) between China and the United States, 2000 to 2018 (HS4 Level). **CN to US represents the trade value of China exports to the US; US to CN represents the trade value of US exports to China. 82 Figure 3.12 Production, consumption, and trade of pig meat(a) and poultry meat(b) in the United States and China in 2018. Source: USDA, 2021 (a) (b) 83 According to Figure 3.13, China has a trade surplus of dried vegetables with the United States. In 2018, China was the main source of U.S. dried vegetable imports, with imports from China accounting for 65% of total U.S. dried vegetable imports. China's vegetable exports are dominated by frozen vegetables, with dried vegetables accounting for only a small portion of the export value. U.S. demand for vegetable imports from countries around the world has been expanding, and vegetable imports have been increasing and will maintain this trend. For soybeans, corn, and sorghum, which are important feed ingredients, the United States has been China's primary source of imports, and the United States has a trade surplus in these agricultural commodities (Figure 3.13). China's imports of corn and sorghum are primarily intended to supplement domestic supplies, while for soybeans it is almost entirely dependent on imports. As can be observed from Table 3.1, U.S. exports of feed ingredients to China have decreased substantially since the U.S.-China trade friction. This has been most pronounced for soybeans, which decreased from 12.3 B in 2017 to 3.35 B in 2018, while for corn and sorghum, the trade war has not had as significant an impact as it has for soybeans. For wheat, an agricultural product imported primarily for food, the trade dispute has changed China's primary source from the United States to Canada. 84 Figure 3.13 Total trade value of vegetable products(Section 2) between China and the United States, 2000 to 2018 (HS4 Level). **CN to US represents the trade value of China exports to the US; US to CN represents the trade value of US exports to China. 85 Table 3.1 The export trade value from the U.S to China by category, and the corresponding proportion in the U.S overall export by category in the year 2017 and 2018, respectively (HS4 Level). Source: UN COMTRADE 2017 2018 Category Trade Value Proportion Trade Value Proportion Soybean $12.3B 56.70% $3.35B 19.40% Wheat $589M 8.98% $191M 3.28% Corn $151M 1.53% $59.7M 0.46% Sorghum $846M 78.50% $533M 62.70% 86 China has a comparative advantage in processing aquatic products because of its lower labor costs compared to the United States. China exports much more processed aquatic products and processed crustaceans to the U.S. than it imports from the U.S (Figure 3.14). In 2018, the U.S. imported 883 M of processed crustacean (20.1%) and 55.2 M of processed fish (12.5%) from China, one of the largest importers from China, and China was also the largest source of processed crustacean(23.7%) and processed fish(18.9%) to the U.S. (UN COMTRADE). For fruit juices, in 2018, nearly half of China's fruit juice export trade was exported to the U.S., while this portion accounted for only 15.6% (384M) of U.S. fruit juice imports. Processed fruits and nuts from China are the most significant source of U.S. imports. The U.S. export strengths are mainly land-intensive and resource-intensive agricultural products, such as soybeans, pork, and corn. China's export strengths are mainly labor-intensive agricultural products, mainly aquatic products, vegetables, and fruits. 87 Figure 3.14 Total trade value of foodstuffs (Section 4) between China and the United States, 2000 to 2018 (HS4 Level). **CN to US represents the trade value of China exports to the US; US to CN represents the trade value of US exports to China. 88 3.6 Conclusion From the perspective of Chinese exports to the United States, the main agricultural products are seafood and processed vegetables and fruits. And since the tariffs imposed by the U.S. in China are mainly focused on high-tech products such as electronics and metal products, and do not involve agricultural products, the impact on China's agricultural exports is relatively small. Imports and exports of U.S. agricultural products have declined in the trade dispute. As China imposed tariffs on U.S. agricultural products, U.S. agricultural exports fell even more significantly (Table 3.2). 89 Table 3.2 The import tariffs that China imposed on the U.S. before and after the Trade War. Category China imposed on the U.S./% Before After Cereals 1 26 Oil seeds 2.42 27.42 Fruits and Vegetables 11.66 36.66 Meat 11.24 36.24 Fish 9.5 34.5 90 Imports of China's major agricultural industry sectors were all hit by the trade dispute, with imports of cereals, oilseeds, fruits, vegetables and nuts, and other plantation sectors all declining significantly. China imports a large number of oilseeds crops each year, mainly soybeans, and in 2017 China imported 93,495,000 tons of soybeans, of which 32,854,000 tons were imported from the United States, accounting for 35.14% of China's total soybean imports (Taheripour & Tyner, 2018). Following the trade dispute, China's soybean imports from the U.S. have decreased by nearly 50% and increased from countries such as Brazil. The U.S. exports about 50 million tons of soybeans year-round, and China is the largest importer, importing about 30 million tons annually. Although several countries are planning to purchase U.S. soybeans, such as Mexico, which has booked nearly 1 million tons of U.S. soybean imports, a fourfold increase over last year, and Pakistan, which has pre-ordered 273,000 tons of U.S. soybeans, they are not in the same order of magnitude as the 30 million tons of soybeans the U.S. exports to China year-round. Despite the U.S. government's decision to subsidize soybean producers, it still cannot make up for the huge losses to U.S. soybean producers caused by the loss of the Chinese market. Soybean meal is a byproduct of soybean crushing, and higher soybean prices will also drive up the price of soybean meal. Soybean meal is an important feed ingredient, along with corn and sorghum in grains. Soybean price increases lead to the price of soybean meal, tariff increases lead to the price of corn and 91 sorghum imports will push up feed prices, thinning the profits of the farming industry, the entire livestock and poultry aquaculture industry will be under collective pressure. Feed costs will eventually be passed on to the price of pigs, eggs, poultry meat and other livestock and aquatic products. For dairy products, as China's dependence on whey imports from the United States is strong, a 25% tariff on dairy products will raise the market price of whey powder and lactose in China, further increasing the cost of infant milk powder producers. At the same time, companies will turn to exporters in countries such as Australia and New Zealand for more suitable prices. From a trade perspective, the agricultural products most affected by the tariffs happen to be the ones with the largest volume of trade between the U.S. and China. Whether you consider the cost factor or the change in importers, the agricultural categories we mentioned earlier are the most likely to be affected by a range of food safety issues. Therefore, in our next study on food safety governance systems, and food safety issues, we will focus on pig meat, poultry meat, fish, processed fruits and vegetables, whey, cereals, soybeans, pork, chicken, soybeans, and other agricultural products. 92 Chapter 4 Food Safety Governance Framework 4.1 Introduction In the context of globalization, both developed and developing countries are exposed to food safety risks. Despite the differences in economic and social conditions between countries and regions, there are commonalities in food safety governance that can be learned from each other. In the US and EU, for example, there have been significant differences in the legal governance of food safety, particularly in the application of the principles of regulation and precaution for genetically modified(GM) foods, but recent legislative developments have shown that there is a convergence in the legal governance of food safety. The United States, which has a positive attitude toward GM food, issued a restriction on the cultivation of GM corn in 2000. The European Union, which has very strict controls on GM, lifted the ban on the import of GM products in 2009 and has approved the import of GM canola from Canada and GM corn from the US (Z. Wang & Lei, 2004). Food safety is a complex social issue, and its management scope is not just the food itself, but also involves planting and animal feeding, food ingredients, food production, food transportation, and sales. Problems in one of the links will ultimately affect the overall safety of food. Therefore, to ensure that each link of the food chain is safe, it is required that the management system and 93 management tools are adapted to the inherent requirements of food safety supervision, to ensure that each link of the food chain is within the scope of supervision. After so many years of development, the United States has accumulated a wealth of experience in food safety regulation, especially in the regulatory system, legislation, and regulatory tools. The experience of the United States has an important value for China to improve the food safety regulatory system. In terms of transparency of policy implementation, there are implications for China as the U.S. food safety management system provides more data that can be easily accessed and a detailed traceability system. However, due to the different development stages, social systems, and cultural backgrounds of the two countries, no one management system is suitable for both. The experience of one country can only be used as a reference for the other country. It is not feasible to copy the experience of one country without considering the specific situation of the other country. Therefore, to further improve the food safety regulatory systems in China and the United States, we need to carefully analyze the strengths and weaknesses of the two countries' current food safety regulatory systems based on their respective experiences. 4.2 The Evolution of Food Safety Governance Framework in China In 1979, China's first food safety regulation, the Regulations of the People's Republic of China on Food Hygiene Management, was introduced, 94 marking the germination of food safety in China. The main characteristics of this stage were as follows: since the People's Republic of China had just been established and the food trade was still relatively homogeneous, food safety problems were not significant in the production, circulation, and sales of food; there were almost no food safety-related laws and regulations; in terms of regulation, the Chinese government initially proposed: on the basis of safeguarding food supply and solving the problem of subsistence, " guaranteeing the quality and safety of food"(Han, 2011). China's food supervision system is divided into four main stages. In 1995, the Chinese government promulgated the Food Hygiene Law of the People's Republic of China, which specifies the food sanitation supervision responsibilities of health administrative departments at all levels. The Food Hygiene Law gave the Ministry of Health (MOH) the power to supervise and enforce food sanitation from a legal level, clarifying the dominant position of the MOH in food regulation (Ma, 2015). At this time, the most important feature of food safety supervision is the decentralized management of numerous agencies. The problem with this decentralized management was that it was difficult to coordinate regulatory actions among various departments. In 1998, the State Council renamed the State Bureau of Technical Supervision as the Quality and Technology Supervision Bureau, which was responsible for supervising quality violations in food production and circulation (Figure 4.1). In 2000, after joining the WTO, China embarked on further reforms 95 of its food policy and regulatory system to meet the standards and requirements of international markets for imported products. In 2001, the Quality and Technology Supervision Bureau merged with the State Administration of Entry- Exit Inspection and Quarantine to become the General Administration of Quality Supervision, Inspection and Quarantine(AQSIQ), and the State Administration for Industry and Commerce(SAIC) was also established in the same year. The AQSIQ and SAIC are responsible for the supervision and management of product quality in production and distribution respectively. At the beginning of 2002, the Chinese Center for Disease Control and Prevention (CDC) and Health Supervision Center were established by the MOH. In 2003, the AQSIQ adopted the "Supervision and Administration on the Quality Safety of the Food Manufacturing and Processing Enterprise”. The law proposed a "food quality and safety market access system", requiring enterprises engaged in food production and processing, must obtain a food production license; the production and processing of food must be tested and approved and stamped with the food quality and safety market access mark; quality and technical supervision departments at all levels are responsible for organizing and implementing the food quality and safety market access system. Also, in 2003, the State Council formed the State Food and Drug Administration(SFDA), adding the function of food management (Zhou et al., 2018). However, the Food and Drug Administration is only a vice-ministerial unit, and food management authority is 96 still scattered among the full ministries of health, agriculture, and commerce, making food safety enforcement activities lacking in unity and coherence. 97 Figure 4.1 Timeline of China's food safety process, 1998 to 2009. 98 In 2008, the melamine detected Sanlu infant formula caused more than 300,000 illnesses, nearly 52,000 hospitalizations, and six infant deaths (Veil & Yang, 2012). In the same year, serious food safety incidents occurred frequently, making the entire community much more concerned about food safety. At the same time, these incidents exposed the problem of cross-functional and unclear authority and responsibility in the supervision of the food safety sector and drove the process of food safety supervision in China. In response to food safety incidents, the State Council merged the SFDA into the MOH in 2008, establishing the MOH as the coordinating authority for food safety supervision. In the same year, the "Regulations on Dairy Quality and Safety Supervision and Administration" was promulgated (Jia & Jukes, 2013). This regulation stipulates the division of responsibilities and legal liabilities of the supervisory departments for raw milk acquisition, dairy production and sales, and sets national standards for dairy quality and safety. On February 28, 2009, China's first Food Safety Law (FSL) was promulgated and came into force on June 1, 2009, promoting the "farm-to-table" regulatory approach proposed and used by the EU (Jia & Jukes, 2013). The design of food safety regulations in China prior to the enactment of the FSL ignored the role of social forces in regulation. For the first time, the FSL emphasized the importance of comprehensive coordination and increased channels for consumer food damage complaints and litigation (Geng et al., 2015). 99 To address the problem of inconsistent food safety standards, the FSL stipulates that food safety standards are mandatory standards. In addition to food safety standards, no other mandatory food standards shall be established. National food safety standards are set by the health administrative department of the State Council with reference to international standards and after listening to the opinions of producers, operators, and consumers. In addition to the above regulatory changes in the FSL, the FSL prohibits food safety authorities from implementing exemptions from food inspection. Thus, the eight-year-long food inspection exemption system has been abolished. Food and drug supervision and management departments shall conduct regular or irregular sampling and testing of food. At the same time, the food safety law introduced the first recall system for unsafe food. The recall system relies not only on the consciousness of enterprises, but also on government enforcement. The State Council has established the National Food Safety Commission (NFSC) to coordinate the various departments, and the MOH coordinates the departments under the authority of the Food Safety Commission and is responsible for the supervision of the catering industry and canteens (Broughton & Walker, 2010). Meanwhile, the Ministry of Agriculture (MOA) is responsible for the supervision of the production of primary agricultural products (Table 4.1). The AQSIQ supervises the food production and processing chain, as well as the imports and exports. The SAIC is in charge of food distribution supervision. The health department is overseeing the foodservice industry and canteens and other 100 consumer segments. The food and drug supervision department is assigned to the comprehensive supervision, organization, and coordination of food safety. 101 Table 4.1 The government agencies related to food and their responsibilities under the 2009 Food Safety Law. Agencies Responsibilities Ministry of Agriculture (MOA) Primary agricultural (livestock) The Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) Processing & production The State Administration for Industry and Commerce (SAIC) Circulation The State Food and Drug Administration (SFDA) Food safety and consumption 102 In March 2013, China launched a new round of institutional reform, integrating the former SFDA, the former AQSIQ, and the former SAIC to form the China Food and Drug Administration (CFDA).In March 2013, China launched a new round of institutional reform, integrating SFDA, AQSIQ, and SAIC to form the China Food and Drug Administration (CFDA) (Table 4.2). TThe new CFDA combines the food safety supervision and management responsibilities of AQSIQ for production and SAIC for distribution, and the corresponding food safety supervision and management teams and testing facilities of AQSIQ and SAIC were transferred to the CFDA. The MOA is responsible for the monitoring and supervision of the quality and safety of agricultural products. The Ministry of Commerce (MOFCOM) was transferred to the MOA for the supervision and management of pig slaughtering (Roberts & Lin, 2016). In 2014, the CFDA and MOA jointly defined and clarified their respective responsibilities and set up an information-sharing mechanism. The Health Family Planning Commission (HFPC) was also established to develop food safety standards and manage risk assessment, and the MOH was no longer retained. This completes the second reform of China's food safety management structure, with a two-stage management system based on the MOA, CFDA, and HFPC (Zhou et al., 2018). On April 24, 2015, the newly amended Food Safety Law of the People's Republic of China was voted by the Standing Committee of the National People's Congress and came into force on October 1, 2015 (Kang, 2019). The revised FSL formalizes the 2013 institutional reform in the form of legislation. The revised 103 FSL strengthens the regulation of food additives, genetically modified foods, food-related products, and online food transactions. The revised FSL draws on the practices of developed countries and requires the establishment of a full traceability system for food safety. Food production and operators should be in accordance with the provisions of this law, the establishment of a food safety traceability system, to ensure food traceability. In the regulation of special foods, the revised FSL in the infant formula clearly stipulates that the formula is not simply filed, but to undergo a rigorous registration review. The revised FSL explicitly prohibits the production of infant formula in separate packages, which legally prohibits the import of foreign milk powder in large packages, and then divided into small packages for domestic sales, which can effectively avoid secondary contamination of milk powder. Also requires the same enterprise shall not use the same formula production of different brands of infant formula powder. 104 Table 4.2 Responsibility of government departments involved with China food regulatory system before and after 2013. Responsibility Departments before 2013 Departments after 2013 Agricultural Products MOA MOA Food import & export AQSIQ AQSIQ Food Processing AQSIQ CFDA Food Circulation SAIC Food sale & consumption SFDA Risk Assessment None HFPC Food safety standard Commission on Food Safety of the State Council HFPC & CFDA 105 On March 21, 2018, the Central Committee of the Communist Party of China released a new national institutional reform program, which clearly stated the formation of the State Administration for Market Regulation (SAMR) to reform the market supervision system and implement unified market supervision (SAMR, 2021a). The new reorganization marks the fourth phase of food safety management in China (Table 4.4). The newly formed SAMR is an agency directly under the State Council, integrating SAIC, CFDA, AQSIQ, the National Development and Reform Commission, and part of the anti-monopoly responsibilities of the Ministry of Commerce (Table 4.3). The SAMR is responsible for the comprehensive supervision and management of the market, including the standardization of food safety. The SAMR is also responsible for food safety and quality supervision. The SAMR is also responsible for the supervision of food safety and quality, and the management of the production, distribution, and consumption of food products (SAMR, 2018). SAMR has 27 agencies, of which 6 are related to food (SAMR, 2018). The Department of Advertising Regulation is responsible for the examination of advertisements for healthy food and formulas for special medical purposes. The Department of Food Production Safety Supervision is in charge of establishing a food safety traceability system as well as keeping control of the food safety situation in the production area. The Department of Food Operation Facility Safety Supervision is required to analyze and master the food safety situation in the circulation and catering service areas. The Department of Special Food 106 Safety Supervision and Regulation mainly manages the registration, filing, and supervision, and management of special foods such as health food and powdered milk for infants and young children. The Department of Food Safety Sampling Inspection is expected to develop and implement food safety supervision and sampling plans. Periodic publication of relevant information and organization of recalls of substandard foods are also responsibilities of this division. This division is involved in the development of food safety standards and food safety risk monitoring. The Department of Food Safety Coordination (formerly the Food Safety Commission of the State Council) is assigned to coordinate major issues in the overall supervision of food and is responsible for cross-regional and cross-departmental linkages in food safety. In terms of cooperation with other departments, SAMR has a division of labor with the Ministry of Agriculture and Rural Affairs (MARA, formerly the Ministry of Agriculture), the National Health Commission (NHC), and the General Administration of Customs (GAC) (SAMR, 2021a). MARA is responsible for the supervision and management of the quality and safety of edible agricultural products from the time they are grown and raised to the time they enter the retail market, or before they enter the production/processing enterprises. After that, it is supervised and managed by SAMR. The MARA is in charge of the supervision and management of animal and plant disease prevention and control, livestock and poultry slaughter, and quality and safety of raw milk procurement. 107 For the assessment of food safety risks, NHC and SAMR need to jointly develop and implement. When the NHC receives reports of potential food safety hazards, it should immediately organize inspection and risk assessment and promptly inform SAMR of the results (SAMR, 2021b). For foods that are concluded to be unsafe, SAMR shall take immediate measures. if SAMR finds in its surveillance that a food safety risk assessment is required, it shall promptly make recommendations to NHC. The GAC is responsible for the supervision of imported food (GAC, 2021). For food safety incidents in other countries that may have an impact on China, or serious food safety problems found in imported food, the GAC shall promptly take risk warning and inform SAMR, which shall take appropriate measures in a timely manner. The two departments need to establish information notification and collaboration mechanisms for imported product defects. The two departments need to establish information notification and collaboration mechanisms for imported product defects. SAMR unified management of defective product recalls work, through consumer reports, accident investigation, injury monitoring, etc. For those who refuse to fulfill their recall obligations, SAMR informs the GAC, which will take appropriate measures in accordance with the law. 108 Table 4.3 Responsibility of government departments Involved with China food regulatory system before and after 2018. Responsibility Departments before 2018 Departments after 2018 Agricultural Products MOA MARA & SAMR (Department of Food Operation Facility Safety Supervision) Food import & export AQSIQ GAC & SAMR (Department of Food Safety Sampling Inspection) Food Processing CFDA SAMR (Department of Food Production Safety Supervision) Food Circulation CFDA SAMR (Department of Food Operation Facility Safety Supervision) Food sale & consumption CFDA SAMR (Department of Food Operation Facility Safety Supervision) Risk Assessment & outbreak response HFPC NHC & SAMR (Department of Food Safety Sampling Inspection) Food safety standard HFPC & CFDA SAMR (Department of Food Production Safety Supervision) 109 Table 4.4 Periods of food safety regulation in China. Periods 1 2 3 4 Year 1998-2009 2009-2013 2013-2018 2018- Mode Segmental supervision is the main focus, supplemented by species supervision Multi-stage fragmented food safety management Two-stage integrated food safety management Integrated management Law Food Hygiene Law Food Safety Law (2009) Food Safety Law (2015) Food Safety Law (2015) 110 4.3 The Evolution of Food Safety Governance Framework in the U.S. An important reason for the relatively well-developed legal system of food safety regulation in the United States is its large number of food-related laws and related legal regulations. Since the founding of the United States, state governments have had a great deal of autonomy in various matters. In fact, although food safety problems have been numerous in the states, there has always been a regulatory and conflict coordination mechanism at the state level. The ultimate role of these mechanisms is twofold: to protect the state's food companies, and to ensure that the interests of the companies are protected in the event of conflicts between the general public and the food companies. Businesses are the primary funders of food regulatory systems in the states. If the power to regulate food safety were to be transferred to the federal government, it would mean that the judicial and administrative systems of the states would no longer have access to the political and financial support of the businesses involved, and it would make the state regulatory agencies that already exist redundant. The idea of a federal-level food safety regulatory mechanism was therefore met with strong opposition from some members of Congress from the outset. In addition, among conservatives, there has always been a paranoid belief in the "free market," that the government should completely withdraw from the 111 market and that the market's merit mechanism would automatically eliminate companies that harm consumers, regardless of how long the process would take. Prior to February 1906, food safety legislation in the United States was difficult to advance until the publication of Upton Sinclair's "The Jungle". This book describes the squalor of Chicago's meat plants, how slaughterhouses oppressed workers and lied to consumers. At the same time, "The Jungle" also reached Europe, and was greatly exaggerated by the European media, seriously affecting the U.S. food industry's overseas market development. Under tremendous domestic and international pressure, the FDA was established in May 1906. The first comprehensive and national law on food safety in the United States was the "Pure Food and Drug Act" enacted in 1906, marking the beginning of the legalization of food safety regulation in the United States. In 1938, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act, which replaced the Pure Food and Drug Act as the basic law in the field of food safety regulation. To make up for the loopholes and shortcomings of the law, the U.S. continued to improve food safety regulatory legislation by enacting amendments in the following 70 years (Clemens & Kadharmestan, 2018). The U.S. food safety regulatory system consists of seven major laws: the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Inspection Act, the Egg Products Inspection Act, the Food Quality Assurance Act, the Federal Insecticide, Fungicide, and Rodenticide Act, and the 112 Public Health Service Act. These seven laws provide the U.S. food safety regulatory system, strict standards, and procedural requirements. On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA), so far, the U.S. food safety regulatory legislation has entered a new period of development (FDA, 2020b). FSMA has made a comprehensive revision of the old law, making FSMA the largest adjustment and change in the U.S. food safety regulatory system in more than 70 years. FSMA emphasizes the concept of prevention-oriented, highlighting risk control, detailed provisions for enterprises to fulfill their main responsibilities, strengthening the overseas inspection of imported food, and focusing on coordination and cooperation between government departments and regulatory capacity building. FSMA introduces the modern concept of food safety supervision, expanding the rights of food regulatory authorities, in the form of legislation on food safety for comprehensive prevention and control, marking the transition of the U.S. food safety regulatory system from the past relying solely on inspection-based to prevention-based. 4.4 Current Food safety regulatory agencies in the U.S. The United States represents a multi-sectoral model of food safety regulation. The U.S. choice of a multi-sector regulatory model mainly comes from the U.S. principle of national governance, i.e., the principle of separation of legislative, enforcement, and judicial powers, which is applied to the field of food 113 safety regulation. In accordance with the above principles, the United States established a comprehensive food safety regulatory system under the responsibility of the Food and Drug Administration (FDA) and Centers for Disease Control (CDC), which are parts of the Department of Health and Human Services (HHS); the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA); the Environmental Protection Agency (EPA); the Customs and Border Protection, the largest federal law enforcement agency of the United States Department of Homeland Security; and the National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration(NOAA) (Figure 4.2). At the same time, this regulatory system is divided into federal, state and local levels, forming an independent and cooperative food safety regulatory network. The U.S. federal food safety regulatory agencies are vertically managed to avoid omissions or duplication in all aspects of regulation and to achieve a truly holistic, gap-free regulatory process. State and local regulatory agencies are responsible for cooperating with federal agencies in enforcing regulations and inspecting food production and distribution points within their jurisdictions. The CDC, which is responsible for the disclosure of information on the investigation and prevention of foodborne diseases and other outbreaks of disease in terms of etiology, incidence, and trends; the Animal and Plant Health Inspection Service (APHIS), which is primarily involved in the disclosure of information on foods made from animals and plants; the EPA, which is primarily 114 in charge of the information on drinking water and pesticides; the NMFS, which focuses on seafood information disclosure; and local government health departments, which focus on cooperation with FDA and other federal agencies on all food safety information within their jurisdictions. 115 Figure 4.2 Structure of U.S. food safety regulatory agencies. 116 4.4.1 FDA The U.S. food and drug safety regulatory structure and operating authority system are a highly centralized system of the federal government. In law and in practice, food safety issues in the United States are centrally managed by the federal government. The most important and broadest regulatory authority is the FDA, which is a subordinate departmental agency of the HHS. The FDA has several departments and agencies that are responsible for a specialized area of food and drug safety regulation, of which the Center for Food Safety & Applied Nutrition(CFSAN) is one of the most important (FDA, 2020). The FDA has centralized and broad food safety responsibilities and authority, regulating 80%-90% of the U.S. food supply, encompassing virtually all foods from farm to fork. This includes dietary supplements (both the finished products and ingredients), bottled water, food additives, infant formula, and other foods, as well as regulation of livestock feed and pet food. The FDA is also responsible for regulating the safety of most imported foods, including a large number of imported seafood and food ingredients. In summary, the FDA's most important responsibilities include: ( 1) Develop and implement food safety standards to ensure the safety of food products; 117 ( 2) Provide pre-market regulation of food products, particularly monitoring of food additives, preservatives, nutritional formulations for infant formula, and drug residues in food animals; ( 3) The FDA has the authority to seize and exercise other legal remedies and to require recalls for products that violate standards; ( 4) nationwide response to foodborne disease outbreaks and outbreak control. 4.4.2 Centre for Food Safety and Applied Nutrition (CFSAN) CFSAN, a division under the FDA, is responsible for “promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled”, as listed below(CFSAN, 2018): （1）Modernize methods for detecting, tracking, and eliminating harmful pathogens and other hazards. （2）Evaluate the safety of new food ingredients and new color additives. （3）Enhance manufacturing practices （4）Ensure foods, dietary supplements, and cosmetics are properly labeled （5）Promote sound nutrition and effective food safety practices （6）Investigate the reasons for foodborne illness outbreaks （7）Target unsafe products 118 4.4.3 USDA & FSIS In terms of food safety, the USDA ensures that commercial supplies of meat, poultry, and egg products(processing and grading) are safe, wholesome, and properly labeled and packaged. Products under USDA jurisdiction and their respective labeling require premarket review and approval through the FSIS. The FSIS is a public health service agency under the USDA. One of the many important responsibilities of FSIS is its labeling guidance, policies, and inspection methods, which will ensure that all labels are truthful and not misleading. The labeling of foods containing more than 3% of meat products or poultry products under the jurisdiction of FSIS must be approved prior to commercial sale within the United States (21 U.S.C. 607(d) and 21 U.S.C. 457(c)) (USDA, 2019). 119 Table 4.5 Summary for responsibility of agencies related to food safety and quality in the U.S. Agency Responsibility FDA Dietary supplements Bottled water Food additives Infant formulas Wild game meat Egg (in shell) Other food (not regulated under USDA) Livestock feeds Pet foods USDA Grading of raw fruit and vegetables Meats (non-game) Poultry Eggs (processing and grading) Certifying organic production EPA Drinking water Pesticide residues CBP Front-line enforcement and referral NMFS Voluntary seafood inspection and grading 120 4.5 Duties of U.S. Food Safety Regulatory Agencies before and after FSMA The FSMA gives FDA the authority to implement more preventive measures and regulatory authority to ensure food safety. Specifically, the FSMA reorganizes and innovates the FDA's authority in the following 4 areas: (1) The FSMA puts preventive controls at the forefront of FDA's authority. Make HACCP mandatory by law for all companies and all segments of the food chain. Except for aquatic products, fruit juices, and low-acid canned foods that meet HACCP requirements in accordance with relevant regulations, other food companies must evaluate their products and take preventive measures to minimize the creation of hazards. The FDA is responsible for monitoring the implementation of these controls and keeping records of them (Drew & Clydesdale, 2015). (2) The FSMA strengthens the FDA's inspection and enforcement authority over food manufacturing companies. The FSMA requires the FDA to commit to allocating its testing resources on a risk-based basis, while taking an innovative approach to testing. It also specifies the frequency of FDA testing of food producers, for example, for high- risk food companies, at least one inspection every seven years (Han, 2014). 121 (3) The FSMA reinforces the FDA's right to ensure the safety of imported food. For the first time, FSMA requires U.S. domestic food importers to ensure that foreign food suppliers have compliant preventive controls in place to ensure the safety of food imported into the U.S. The FDA is licensed to authorize third parties to certify that the equipment and facilities of foreign imported food manufacturers fully meet U.S. food safety standards. (4) FDA's authority to enforce timely recalls of problem foods has been strengthened For the very first time, FSMA authorizes the FDA to impose mandatory recalls on all food products. Under FSMA, the FDA first has the authority to set stricter safety standards for imported foods. The FDA can directly order a mandatory recall of all foods with safety hazards and has the authority to charge the offending importer for the costs associated with the recall. 4.6 Conclusion There is adverse selection in the food market. That is, asymmetric information between consumers and producers can lead to high-quality food being squeezed out of the market by low-quality food. Therefore, the key to solving the food safety problem lies in developing effective systems, and effective regulation that reveals the safest information at the lowest information cost and reduces information asymmetry in the food market to the greatest extent (Akerlof, 1970). 122 The law is the institutional basis for ensuring the implementation of food safety management policies and their effects. China has made some progress in food safety legislation, with the introduction of the FSL, FSL(2015), and the Food Safety Implementation Regulations. However, it is easy to see from the preceding analysis that the regulations interpreting China's food safety law are not as specific and detailed as those of the FSMA. The FSL is very limited in its description of how it is to be implemented, resulting in many of the provisions of the law being poorly operational in practice. The U.S. food safety regulations, on the other hand, are limited by the federal government's regulation of the states, making the degree of looseness and stringency vary greatly from state to state. Likewise, unlike China, where local finances are centrally allocated, the U.S. states have limited funds to allocate to food safety. Many aspects of food safety that should be regulated by the FDA are assigned to the state government for inspection, reducing the FDA's authority to regulate nationally. Because food safety is so carefully regulated, some food companies have appeared to develop food safety programs with the goal of fully complying with the regulations, rather than with the goal of protecting consumer rights. Similar to the U.S., China used to implement the "segment regulation as the main, supplemented by variety regulation" multi-sectoral regulatory model, but China has unclear authority and responsibility in the regulatory process, the lack of cooperation and other shortcomings. The advantage of segmented 123 regulation is that if a new product is launched, the way of safety regulation of this product will not change, and it will still be managed according to each step from production, processing to finished products. If the U.S. approach is followed, a new product on the market will need to first understand the management of each raw material, which takes away some of the flexibility in policy development and makes it difficult to redevelop or modify the food safety management system. FSMA has strengthened some of the leading roles and dominant position of FDA in the U.S. food safety regulation, and centralized the allocation of administrative resources and the division of enforcement power to FDA. We can see that China also wants to concentrate the power of food safety regulation in the institutional reform in 2018. Although the U.S. food safety regulatory authority is still divided among multiple departments, different types of food are assigned to different departments, so that each department has a clear division of labor and each has its own role, and the effective operation of the food safety regulatory system is achieved through close collaboration. FSMA has imposed higher standards and more onerous requirements on foreign companies exporting food to the United States in terms of preventive control systems, food facility registration, inspection, and certification, which will directly lead to higher production costs for these companies and thus will have a significant impact on international food trade. Unlike the U.S., where both domestic and imported food is primarily regulated by the FDA, Chinese food exports have long been regulated by a separate department(Until 2018). 124 Chapter 5 Food Safety Regulations and Issues Foodborne illness is considered one of the most widespread public health problems worldwide. The CDC estimates that 48 million people in the United States get sick from foodborne illnesses each year, with 128,000 hospitalizations and 3,000 deaths (CDC, 2020c). Over the past few decades, multiple food poisoning incidents in various countries have renewed international concern about foodborne illness. Despite the global push to use Hazard Analysis and Critical Control Points(HACCP) as a risk management system for food safety, the expanding trade in animal foods and the growing number of immunocompromised populations have not led to a downward trend in the prevalence of foodborne illness. According to the latest data from WHO, one in 10 people worldwide gets sick from contaminated food (WHO, 2021b). Because of this, controlling food-borne diseases remains a serious health issue for the world. Foodborne diseases are caused by human intake of contaminated food, including a wide range of diseases caused by parasites, chemical substances and pathogenic bacteria that contaminate food in different parts of the food production and preparation process. When two or more individuals get the same illness from the same contaminated food or beverage, the event is called a foodborne illness outbreak (FDA, 2021). 125 Foodborne disease surveillance systems include event-based surveillance (EBS), indicator-based surveillance (IBS), and integrated food chain-based surveillance (IFS) (Ford et al., 2015). EBS utilizes informal data and takes up minimal resources, but outbreak etiology is rarely identified due to the lack of laboratory diagnostic capacity. IBS is often considered a traditional foodborne disease surveillance system that includes notification disease surveillance, symptom surveillance, sentinel surveillance, hospital-based diagnosis and death registration, laboratory-based surveillance, and antimicrobial resistance surveillance. IFS, on the other hand, uses data from every link in the food supply chain for surveillance, and is currently the most sophisticated foodborne disease surveillance system in the world. Each surveillance system has a different focus, is unique and compatible with each other, and has achieved varying degrees of success in foodborne disease surveillance. In many countries, especially in developing countries, little research has been conducted on foodborne diseases and very limited resources are available. WHO is currently working with other national public health agencies to help countries strengthen disease surveillance. WHO established the Foodborne Disease Burden Epidemiology Reference Group (FERG) in 2007 to initiate global research on foodborne diseases (WHO, 2015). FERG's work includes collecting existing foodborne disease data and examining models for assessing foodborne disease when data are lacking. According to the FERG, the main problem facing foodborne disease globally is the lack of data. WHO encourages developing 126 countries to use the results and methods available in the United States, the Netherlands, the United Kingdom and other countries to estimate foodborne disease burden as much as possible. 5.2 Food-borne diseases and surveillance in China Timely detection and control of foodborne disease outbreaks is the main purpose of foodborne disease surveillance. Since 2002, China has established a foodborne pathogen surveillance network for continuous active surveillance of Salmonella, Listeria monocytogenes, Escherichia coli O157:H7 and Campylobacter in food. PulseNet China was established in 2004, and Pulsed- Field Gel Electrophoresis (PFGE) typing techniques were established in several provincial and municipal Centers for Disease Control and Prevention (China CDC) laboratories nationwide (Xu, 2012). In 2010, China began to establish a national foodborne disease reporting system to monitor foodborne disease events with two or more incidences (or one or more deaths). The China CDC has also built a real-time network surveillance system for 39 infectious diseases, which consists of a five-tier networked infectious disease surveillance and reporting system from the township to the national level and a three-tier network platform from the local city to the national level (J. Liu et al., 2018). According to the regulations, infectious disease cases detected in hospitals are reported to the national China CDC database via Internet/NPN in real-time, and all medical institutions nationwide can access the central database at any time to obtain information. 127 Through continuous improvement of the foodborne disease surveillance network, China CDC at all levels has been strengthening its awareness and surveillance of foodborne disease prevention and control. With the implementation of the FSL, relevant food regulatory authorities and business units have strengthened their monitoring and management of food safety, and relevant departments have strengthened health promotion of food safety knowledge to the general public. These measures have reduced the likelihood of foodborne disease outbreaks and played a positive role in the prevention and control of foodborne diseases in China. 5.3 Food-borne diseases and surveillance in the U.S. In 1973, the CDC established the Foodborne-Disease Outbreaks Surveillance System (FBDOSS) to collect information on foodborne disease outbreaks. information on foodborne disease outbreaks. Foodborne disease outbreaks in the United States are handled by the state and local public health departments, and outbreak information is transmitted electronically to the CDC's Foodborne Disease Outbreak Surveillance System. The CDC aggregates the reported state data at the national level and recommends measures to improve food safety by analyzing the pathogens, causative foods, and contaminants that cause foodborne illness outbreaks (Molnar et al., 2006). The CDC uses PulseNet (the national molecular subtyping network for foodborne disease surveillance) and Foodborne Outbreak Net to provide technical support when outbreaks of foodborne disease occur in multiple states. 128 PulseNet, the CDC's national molecular typing network for pathogenic bacteria, was established in 1996 with the participation of four states. By 2001, all 50 states, the FDA, and the FSIS were members (CDC, 2019b). The Foodborne Outbreak Net, the CDC's foodborne disease outbreak epidemiology group, conducts epidemiological investigations based on information provided by PulseNet and identifies foods suspected of causing outbreaks. Based on the CDC's findings, the FDA and FSIS will take appropriate food safety measures to protect consumer health, such as recalls of disease-causing foods and issuance of warning messages. During this time, the CDC continues to track new cases and determine when outbreaks end. Thus, the CDC acts as a coordinator in the management of foodborne illness outbreaks that affect multiple states. 5.4 Comparison of Food-borne diseases surveillance between China and the U.S. Because foodborne disease infections are not restricted by national borders, international laboratory-based surveillance networks have been established. These international surveillance networks, often based on national sentinel surveillance systems, ensure rapid information exchange across borders in the event of a foodborne disease outbreak. In addition to maintaining food safety in the U.S., the PulseNet network is also actively involved in food safety monitoring and early warning efforts in the international community. As a typical example of PulseNet's internationalization, China PulseNet has become a national pathogen surveillance platform for bacterial infectious diseases. 129 One problem with the IBS surveillance system is underreporting of foodborne illnesses, as many patients with foodborne illnesses do not visit hospitals or cannot be diagnosed due to atypical patient symptoms. Another challenge with the IBS surveillance system is that there can often be days or weeks between the onset of obvious symptoms and the health department's awareness of an outbreak, resulting in delays in identifying foodborne illness outbreaks. A laboratory-based surveillance system was implemented in 2009 in Guangdong Province, China. However, this surveillance is limited by many factors, including low sensitivity of laboratory confirmation of Salmonella infection, only a few hospitals sending specimens, difficulties in case definition, and low strain isolation rates. Compared with the United States, there is still a gap in China's relevant foodborne disease surveillance and early warning capabilities. Currently, China's foodborne disease surveillance network is mainly based on the IBS surveillance system as the leading framework and laboratory-based surveillance, antibiotic resistance surveillance, and sentinel surveillance methods as the main surveillance tools. As China's foodborne disease surveillance system continues to improve, the establishment and adoption of a tiered surveillance approach may be considered in the future. The first step is to identify foodborne disease outbreaks through EBS, then to enhance IBS capabilities thereby strengthening foodborne 130 disease surveillance, and ultimately to achieve effective implementation of a complete food chain surveillance system. 5.5 Food safety disclosure mechanisms in China and the United States A sound food safety information disclosure mechanism can effectively address the "market failure" and "government failure" caused by information asymmetry and improve the quality of food safety. There is a large gap between China and the U.S. in the construction of the basic system of food safety information disclosure (Table 5.1). In terms of information acquisition, as early as 1999, the U.S. established the Laboratory Response Network (LRN), which aims to ensure that major infectious disease outbreaks and major public health emergencies can be rapidly diagnosed as pathogens, and that authoritative testing agencies ensure the timeliness of food safety information collection (Morris et al., 2003). In contrast, the collection of food safety information in China cannot be done in a timely and accurate manner. A small number of inspection agencies undertake a large amount of the work. Detection technology is also very backward. For example, the testing of agricultural products such as vegetables, fruits, grain, and oil crops can only detect the presence of pesticides, fertilizer residues and the amount of residue, but not involve the relevant detection of heavy metals for a long time. For traceability, according to FDA regulations, all food companies are required to record and maintain detailed information on all aspects of food 131 production, processing, packaging, and distribution. At this stage, most Chinese food companies only record and keep information that is beneficial to the company. To achieve coordination of food safety information, the U.S. has established the unified and authoritative website, foodsafety.gov. Information from different departments and products is aggregated through foodsafety.gov, thus greatly improving the speed of dissemination and efficiency of food safety information utilization. China's distribution channels are random and lack a uniform and powerful information platform. At present, China's food regulatory authorities mainly release information through the Internet, SMS, TV, newspapers, and government reports. This has led to a state of self-contradiction in the information resources of various government departments. In terms of legislation and regulatory authorities, unlike in the United States, China's food regulatory authorities are divided on an administrative basis. This approach, in which one department is responsible for one link, does not fully take into account the characteristics of the food safety issue itself, resulting in a fragmented body of food safety information disclosure and a lack of effective information sharing and coordination mechanisms. According to Article 118 of the newly amended Food Safety Law, China has a unified food safety announcement system and strict requirements for the timeliness, objectivity and accuracy of food safety information (Snyder & Kim, 2018). In practice, however, the relevant authorities have not implemented this 132 provision, and there are cases of an incomplete and untimely disclosure. For example, in 2019, the market supervision department of Suzhou City, Jiangsu Province, conducted sampling and testing of food in a market, and in the testing of fried melon seeds in certain stores, it was found that a large number of melon seeds contained different doses of alum, which could easily lead to brain and nerve cell damage after consumption, with serious consequences (Long & Yang, 2020). The regulator should announce the relevant specific information in time to avoid more people being duped, but it not only did not announce this news in the first place, but also subsequently only published the data without specifying the list of specific stores. 133 Table 5.1 Comparison of food safety disclosure mechanisms between the U.S. and China. Information Disclosure The U.S. China Acquisition Authoritative testing institutions; advanced testing technology; extensive collection channels Lack of authoritative inspection institutions; backward testing technology; scattered collection channels Traceability Complete information records to ensure the traceability of food safety information Incomplete information records and lack of effective information tracing system Publish A unified and authoritative release platform has been established to share information Lack of a unified authoritative information disclosure platform, unable to achieve information sharing Regulatory authorities A clear division of labor and a full range of information disclosure subjects Blurred division of labor; scattered information disclosure subjects Legislation Information category and food safety legislation is complete Information-based legislation is abstract; food safety legislation is scattered 134 5.6 Foodborne disease outbreaks 5.6.1 China According to WHO estimates at the beginning of the 21st century, the underreporting rate of foodborne illness in China was over 95% (Fung et al., 2018). For China, the establishment of a complete foodborne disease surveillance system is of great importance to enhance food safety and national health. In 2001, China included the "Research on Foodborne Disease Surveillance Technology" as a national science and technology project, and it was accepted by a panel of experts in 2003. Figure 5.1 shows that from 2001 to 2003, the number of detected foodborne disease outbreaks increased from 522 to 781. However, since 2003, the number of reported outbreaks has been decreasing almost continuously until 2010. In 2011, China's National Center for Food Safety Risk Assessment put the construction of a foodborne disease surveillance network on the agenda and formally adopted the program in 2013. To collect information on molecular subtypes of foodborne bacteria to facilitate early detection of geographically dispersed common source foodborne outbreaks, China established a national foodborne disease molecular tracing network (TraNet) in 2013 (W. Li et al., 2020). Although PulseNet China is available, the ultimate goal of TraNet is to build a national laboratory network for foodborne outbreak detection similar to PulseNet in the United States. From 2013 to 2015, the number of detected foodborne disease outbreaks skyrocketed at an average rate of 50% per year. 135 This shows the usefulness of a standardized and unified surveillance network for the detection and reporting of foodborne illnesses. The revised version of the Food Safety Law implemented on October 1, 2015, defines foodborne diseases as "infectious and toxic diseases caused by the entry of pathogenic factors into the human body in food, including food poisoning" (Geng et al., 2015). In the 2009 version of the Food Safety Law, the definition of foodborne illness does not include food poisoning. The cases related to food poisoning are counted in food safety accidents. Meanwhile, the FSL (2015) stipulates for the first time that medical institutions that find patients or suspected patients with foodborne diseases should report to the health administrative department in a timely manner. If the county-level health administrative department thinks it is related to food safety, it should promptly inform the food and drug supervision and management department at the same level. So we can find that in Figure 5.1(Li et al., 2020), the number of foodborne disease outbreaks climbed from 2342 in 2015 to 4048 in 2016, nearly twice as many as in the previous year, and the largest number of foodborne disease outbreaks ever counted in 2017. 136 Figure 5.1 Number of foodborne disease outbreaks in China, 2001-2017. Note. The data of 2001 and 2002 are from the National Report of Public Health Emergencies issued annually by the China Ministry of Health. The data from 2003 to 2017 are adapted from “Surveillance of foodborne disease outbreaks in China, 2003–2017” by Li et al., 2020, Food Control, Volume 118 137 5.6.2 U.S. By 2001, all state, local, and territorial health departments were submitting reports through the Electronic Foodborne Outbreak Reporting System (eFORS). It was not until 2008 that the system transitioned to an enhanced form and reporting platform, the National Outbreak Reporting System (NORS) (CDC, 2021c). NORS also collects information on outbreaks of enteric disease from modes of transmission other than food, including: human-to-human contact, animal contact, water, and environmental contamination. The average number of foodborne illness outbreaks per year in the surveillance area from 2001 to 2017 was 989, involving a total of 326,292 illnesses (Figure 5.2 & Table 5.2). 2004 had the highest number of outbreaks and the highest number of illnesses. The lowest number of illnesses and outbreaks occurred in 2009. There was an overall decreasing trend in the number of incidents. The number of deaths did not coincide with the peak number of events, with the highest number in 2011 and the lowest in 2009, and the death rate was less than 1%. Prior to the introduction of FSMA in 2009, there was an average of more than 1,000 foodborne illness outbreaks per year, with an average of nearly 25,000 illnesses, almost 850 hospitalizations, and more than 16 deaths (Table 5.2). After 2009, the average number of foodborne illness outbreaks per year dropped to 832 and the number of patients fell to 14,537. At the same time, 138 however, the number of hospitalizations and deaths rose to 867 and 25, respectively. It is clear from the graph below that with the introduction and implementation of FSMA, there has been a significant decrease in foodborne illness outbreaks. FSMA has done a good job of controlling foodborne illness through proactive prevention rather than reactive reporting. Moreover, with the expanded authority of the FDA and CDC, timely communication between local and federal authorities, and a uniform reporting system, the delivery of information on foodborne illnesses have become more effective. 139 Figure 5.2 Number of foodborne disease outbreaks by year in the U.S., 2001- 2017. Note. The data from 2001 to 2017 are adapted from Surveillance for Foodborne Disease Outbreaks, United States, 1998-2002, 1998-2008, 2006, 2007, 2009-2015, 2016, 2017, Annual Report, Centers for Disease Control and Prevention (CDC). 140 Table 5.2 Number of foodborne disease outbreaks, illnesses, hospitalizations and death by year in the U.S., 2001-2017. Note. The data from 2001 to 2017 are adapted from Surveillance for Foodborne Disease Outbreaks, United States, 1998-2002, 1998-2008, 2006, 2007, 2009-2015, 2016, 2017, Annual Report, Centers for Disease Control and Prevention (CDC). Year Outbreaks Illnesses Hospitalizations Deaths 2001 1249 25202 666 11 2002 1318 24951 732 14 2003 1089 23079 687 24 2004 1327 29012 779 22 2005 964 19900 601 8 2006 1256 28881 1169 10 2007 1098 21302 893 18 2008 1028 23133 1243 22 2009 668 13790 553 7 2010 853 15865 630 16 2011 795 14300 985 49 2012 835 15002 863 21 2013 829 13516 1102 25 2014 874 13347 746 28 2015 926 15555 1000 21 2016 854 14430 944 28 2017 858 15027 979 26 141 5.7 Comparison of foodborne disease outbreaks between China and the U.S. by food vehicles The contaminated foods that cause individual illnesses are rarely identified. Thus, foodborne disease outbreak surveillance offers valuable insights into the types of pathogens causing foodborne disease, the foods and ingredients implicated, and the settings in which transmission occurs. Regarding the classification of contaminated food, China and the United States are very similar. The classification of food carriers that cause foodborne disease outbreaks is based on epidemiological evidence. Foodborne disease outbreaks that could not be identified by food type would be defined as unknown. Foodborne illnesses caused by multiple foods were defined as complex food. Due to the lack of information on the specific classification of foodborne illnesses in China before 2003 and after 2017, the food vehicles comparison between the US and China started from 2003 to 2017. Since the classification of food varies, we filtered data for selected foods based on the trade volume in the previous section. From 2003 to 2017, the number of foodborne disease outbreaks in China with clear causative foods was 16902, accounting for 86.6% of the total number of outbreaks (Table 5.3). The food vehicles we selected as the cause of disease were divided into 8 categories, and those outside the 8 categories were classified as others. Among the 8 food categories, plant and animal categories accounted 142 for 50.9% and 21.1% (44.08% and 18.27% of the total number of outbreaks) of the definite outbreaks of disease-causing foods, respectively. The total number of foodborne disease outbreaks caused by fungi was 4342, accounting for 22.25% of the total number of outbreaks. The reasons for the high number of foodborne illnesses caused by fungi are related to the unique dietary habits of China. YunNan, a province in China, has an average of nearly 40 foodborne illness outbreaks per year due to wild mushroom consumption, with nearly 500 people suffering from food poisoning in June and July each year (Shen et al., 2016). Foodborne illnesses caused by fungi have become one of the most challenging issues in food safety in China due to the high number of hospitalizations, the high mortality rate, and the difficulty in controlling consumption by the population. The number of incidents caused by meat products was the highest among animal foods, with 2180 cases, accounting for 11.17% of the total number of outbreaks, followed by fungi (Table 5.3). Among plant foods, except for fungi, the highest number of incidents was caused by Grains and Beans, 5.24% and 1.66% respectively, followed by vegetables, 8.99%, and the lowest was fruits, 1.2%. Within the animal category, aquatic animals accounted for 5.56% of the total number of outbreaks, and dairy is the lowest. 0.33%. 143 Table 5.3 Number and percentage of foodborne disease outbreaks, illnesses, hospitalizations, and deaths by food category in China, 2003-2017. Note. Data is adapted from “Surveillance of foodborne disease outbreaks in China, 2003–2017” by Li et al., 2020, Food Control, Volume 118 Food category Outbreaks Illnesses Hospitalization s Deaths n % n % n % n % Fungi 4342 22.25% 19070 8.09% 12128 11.29% 639 43.86% Meat 2180 11.17% 36953 15.67% 17158 15.97% 57 3.91% Vegetable s 1755 8.99% 22620 9.59% 10022 9.33% 37 2.54% Aquatic animal 1085 5.56% 11815 5.01% 4637 4.31% 41 2.81% Grains 838 4.29% 12342 5.24% 7099 6.61% 124 8.51% Beans 304 1.56% 3923 1.66% 1736 1.62% 12 0.82% Fruit 234 1.20% 1249 0.53% 621 0.58% 8 0.55% Dairy 65 0.33% 885 0.38% 441 0.41% 1 0.07% Others 6099 31.25% 78061 33.11% 35533 33.05% 414 28.42% Unknown 2615 13.40% 48836 20.71% 18095 16.84% 124 8.51% Total of selected categories 10803 55.35% 108857 46.17% 53842 50.11% 919 63.07% Total 19517 100.00 % 235754 100.00 % 107470 100.00 % 1457 100.00 % 144 The data on foods that cause foodborne illness outbreaks are very different between the United States and China. For example, in 2017, of the 841 foodborne illness outbreaks that occurred in the United States, only 218 could be categorized as caused by an identified food, 142 others were triggered by multiple foods, and 481 outbreaks could not be identified food vehicle (CDC, 2019b). Because the number of hospitalizations and deaths were very small in our selected food categories and the data were not uniform before and after 2009, we analyzed only the number of outbreaks and the number of illnesses on the U.S. side. Also, because of the different data sources for the food category, (Annual report data could not be updated in real-time), some data may appear slightly different. Similar to the situation in China, foodborne disease outbreaks caused by meat and aquatic products also accounted for a large proportion of the total in the U.S. Shellfish and fish among Aquatic animals had 381 and 697 cases, respectively, from 2003 to 2017 (Table 5.4). Usually, Scombroid toxin/histamine and Ciguatoxin are the main causes of fish contamination, while Salmonella is the main reason for meat being contaminated. Foodborne disease outbreaks caused by fruits, although low in number, 0.56% of the total outbreaks and only higher than 0.38% of grains and beans, have a higher mortality rate. Using data from 2009 to 2015 as an example, fruits contaminated with Listeria monocytogenes caused 3 foodborne illness outbreaks, 184 illnesses, 179 hospitalizations, and 41 deaths (CDC, 2015). The 145 same was true for dairy contaminated with Listeria monocytogenes, which led to 14 foodborne illness outbreaks, 106 illnesses, 70 hospitalizations, and 14 deaths between 2009 and 2015. Vegetables and fruits contaminated with Salmonella also have a high lethality rate. 146 Table 5.4 Number and percentage of foodborne disease outbreaks and illnesses by food category in the U.S., 2003-2017. Note. Data is adapted from Surveillance for Foodborne Disease Outbreaks, United States, 1998- 2002, 1998-2008, 2006, 2007, 2009-2015, 2016, 2017, Annual Report, Centers for Disease Control and Prevention (CDC). Food category Outbreaks Illnesses n % n % Shellfish 381 0.90% 3976 0.35% Fish 697 1.64% 3816 0.34% Dairy 275 0.65% 6116 0.54% Beef 394 0.93% 7893 0.70% Pork 298 0.70% 6834 0.60% Poultry 647 1.52% 15030 1.32% Grains and beans 163 0.38% 2579 0.23% Fruits 238 0.56% 8126 0.72% Vegetables 397 0.93% 18028 1.59% Total of selected categories 3490 8.21% 72398 6.38% Total of all categories 42493 100.00% 1134559 100.00% 147 5.8 Import Refusals issued by the U.S. U.S. food companies or farms are subject to uniform food safety requirements whether they are in the United States or in another hemisphere. FDA's approach to enforcement overseas differs from that in the United States, so the U.S. Congress has asked FDA to establish a number of responses to ensure the safety of imported foods. The FDA's regulatory strategy for imported foods is essentially the same as its regulatory efforts for domestic foods. FSMA recognizes the importance of aligning enforcement resources based on risk, so FDA is continuing to improve its ability to identify high-risk areas (Buzby et al., 2008). We have selected several food categories that require additional attention for the United States based on the volume of trade between the United States and China. These food categories are characterized by high trade volumes, high risk, and are primarily exported from China to the United States rather than vice versa. The Food, Drug, and Cosmetic Act (the Act) authorize FDA to detain regulated products that appear to be out of compliance with the Act. When a violation occurs, the FDA regional office will issue an "FDA Notice of Action" to the owner or consignee (FDA, 2019). The FDA will issue another "FDA Notice of Action" to reject the product if the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance. Rejected shipments must be destroyed or exported under the supervision of CBP and FDA within 90 days of receipt of the notice. The Import Rejection Report 148 (IRR) provides a list of rejections by country/region and product based on industry codes. The FDA developed the IRR to provide the public with information on shipments that violate FDA laws and regulations. The following data related to U.S. import refusal is from the FDA Data Dashboard(https://datadashboard.fda.gov/ora/cd/imprefusals.htm). The automatic detention system is also known as "Detention without Physical Examination" (DWPE) is a major measure implemented by the FDA to manage imported food. (FDA, 2019). The FDA generally does not take DWPE measures, and will only use them if no other solution can be found. The FDA conducts random inspections of imported products, generally at a rate of 3-5%, and if a sample passes, the product will be released. In addition to random inspection there is a measure, that is, for the potential problems of imported products, the entry must be inspected batch by batch, rather than random inspection, which is the "automatic detention" measure. From Figure 5.3 we can find that the products rejected by the FDA have remained at a flat level from 2002 to Mar 2021. Only in 2011, it reached a record- breaking, a total of 82,019 import refusals. Analysis of refusals by industry groups shows that three broad categories of products—human foods, drugs and devices—combined accounted for 80 to 90 percent of FDA import refusals (FDA, 2020f). In 2011, the number of devices refused was much higher than in other years. As the two largest trading partners of the United States, the FDA has 149 given China and Mexico the most import alerts in total. The vast majority of the devices that were rejected for import in 2011 came from Mexico. 150 Figure 5.3 Import refusals by FDA, 2002- Mar 2021. Note. Data is from the FDA import refusals Dashboard https://datadashboard.fda.gov/ora/cd/imprefusals.htm 151 From Figure 5.4, we can find that although there is an occasional decline, the overall FDA refusal of importing Chinese products shows an upward trend. This trend is roughly the same as the total amount of U.S.-China trade. As the total volume of U.S.-China trade continues to grow, the FDA is rejecting more and more products from China, but the percentage of rejected products to the total remains roughly the same. Human food accounts for nearly 40% of the import alter issued to China by the FDA each year. Looking at the food-related import refusal alone, there is a downward trend from 2011 (Figure 5.5). From 2004 to 2020, the average number of Chinese food products rejected by the FDA is about 800. 152 Figure 5.4 Import refusals related to China, by product category, 2002- Mar 2021. Note. Data is from the FDA import refusals Dashboard https://datadashboard.fda.gov/ora/cd/imprefusals.htm 153 Figure 5.5 Import refusals about food related to China, by year, 2002- Mar 2021. Note. Data is from the FDA import refusals Dashboard: https://datadashboard.fda.gov/ora/cd/imprefusals.htm 154 The FDA's rejections of Chinese food products reflect the composition of imported products. As well as the volume of imports, FDA rejections of fish/seafood products, vegetables/vegetable products, and fruits/fruit products from China account for more than 50% of the total food-related import refusals (Figure 5.6). Fish/seafood products account for a quarter of all and food-related import refusals. Vegetables and fruit products accounted for 19.4% and 11.0%, respectively. The most common problems cited by the FDA are "filth," unsafe additives, inadequate labeling, and lack of proper manufacturer registration. These problems usually occur during the processing and handling of the food. Another of the most common problems is the possible presence of harmful veterinary drug residues in farmed fish. This problem usually occurs on farms. (Buzby et al., 2008). The FDA has rejected relatively few Chinese foods for harmful pesticide residues and pathogens. Based on the above, we will focus on analyzing additives, labeling, manufacturer registration, and pesticide/veterinary drug residues for China's exports of aquatic products, vegetables, and fruit products to the United States. 155 Figure 5.6 Total food-related import refusals, 2002 to Mar 2021. Note. Data is from the FDA import refusals Dashboard https://datadashboard.fda.gov/ora/cd/imprefusals.htm 156 5.9 Import Refusals Issued by China With the influx of a large number of imported foods, the overall trend of the batches of food products detected by the Chinese General Administration of Customs(GAC) as unqualified and refused entry in recent years is on the rise. As China's regulatory bodies regarding imported food have had several reorganizations and changes, the earlier websites managing imported food have been discontinued and the data has not been updated after 2018, so the data we use is the largest time span on record. According to GAC, the number of unqualified batches of imported food in China was 1,543 in 2009 and increased to 1,753, 1,857, and 2,499 batches from 2010 to 2012, respectively (Figure 5.7). From 2013 to 2016, the number of failed batches of imported food showed an "M" shape change, reaching 2164,3503,2805, and 3042 batches respectively. However, in 2017, the number of unqualified batches of imported food was a spurt of growth, an increase of 117.98% over 2016, reaching a record high of 6631 batches. It shows that the problem of imported food in China is still serious, and its safety needs to be given high priority. The report released by GAC in 2016 shows that the top five origins of food products refused entry were Taiwan(722 batches, 23.73%), the United States(198 batches, 6.51%), Japan(182 batches, 5.98%), South Korea(162 batches, 5.33%), and Malaysia(143 batches, 3.68%) (Yin et al., 2018). Food from these five countries/regions accounted for nearly half of the food products denied 157 entry. The distribution of the main sources of unqualified imported food is very similar to the main importing countries of China. In 2017, the abuse of food additives, microbial contamination, and excessive heavy metals were the safety and health issues affecting imported food, accounting for 23.18% of the total batches of imported food detected as unqualified (Yin et al., 2018). Among the non-safety and non-hygiene problems of imported food, the certificate was not qualified, exceeded the shelf life, labeling did not meet the regulations were the main problems, accounted for 65.71% of the total batches of imported food detected unqualified. In contrast, in 2016, the proportion of hygiene problems such as abuse of food additives and microbial contamination was 43.95%, while the proportion of non-safety hygiene problems was 39.84%. As can be seen, compared to 2016, there was a significant change in food safety issues for imported food in China, with non-safety and non-hygiene issues dominating. 158 Figure 5.7 Unqualified imported food batches in China, 2009 to 2017. Note. The data are adapted from Introduction to 2018 China Development Report on Food Safety by Yin et al. 159 5.10 Aquatic Products 5.10.1 SPS Notifications According to the SPS agreement, each member country in the implementation of new or revision of the original SPS measures in the relevant technical regulations, standards, limits, and conformity assessment procedures, must be published in a timely manner to other member countries. (WTO, 2021). This official document to publish information to WTO member countries is called SPS notification. At the same time, for a fairer and more transparent international trade environment, the SPS agreement also provides that: for a country to issue a notification, other WTO member countries have the right to consult, and within a specified period of time to notify the content of non-compliance with the SPS agreement to raise comments and questions to avoid unnecessary trade barriers. In recent years, the WTO has received a significant increase in the number of SPS notifications from the United States. The U.S. SPS notification pays particular attention to the pesticide and veterinary drug residues, food additives, animal and plant inspection and quarantine, bacteria and microorganisms, such as the improvement of limit standards and norms, other aspects such as biotoxin exceedance, pollutant limits also account for a certain proportion. Within the framework of the SPS agreement, every country is working to improve and update its food safety regulations. By analyzing the SPS notifications affecting aquatic products issued by the U.S. from 2002-2012, it can be found that the U.S. notifications mainly focus 160 on the following types of measures: related to pesticide and veterinary drug residue limits (1546), animal and plant quarantine (564), food additive regulations and standards (308), and other categories (300) (X. Liu, 2014). 5.10.2 Regulation The FDA is responsible for the development and enforcement of fish quality and standards and regulates the procedures for importing and exporting fish and shellfish. FDA governs fish and shellfish mainly refers to oysters, salmon, shrimp, and tuna these types of fish products, including definitions, types of raw materials, production processes, product specifications, measurement methods, sampling and acceptance procedures, labeling, and other aspects of the requirements. The USDA is primarily responsible for the regulation of catfish and, together with the FDA and state agencies, is responsible for the implementation of the shellfish sanitation program. The National Oceanic and Atmospheric Administration (NOAA), a division of the U.S. Department of Commerce (USDC), has a Memorandum of Understanding with the FDA to conduct a joint fish inspection program, and NOAA provides inspection and testing services for processing fishing vessels and fish processing plants under the Seafood Inspection Program (NOAA, 2021). Aquatic products as one of the earliest implementations of HACCP food categories, management has been very strict. In response to FSMA, the U.S. mandated the "Prior Notice of Imported Foods" regulation on September 6, 2011. U.S. companies are required to provide advance notification to the FDA when 161 importing fish products to help the FDA make decisions to prevent potentially risky fish products from entering the United States (FDA, 2020c). In 2014, FDA used a novel laboratory test to simultaneously detect multiple unapproved veterinary drugs, including sulfanilamide (Turnipseed et al., 2018). After the discovery of sulfonamide, FDA denied the importation of the shipment and placed the processor on FDA Import Alert 16-124, titled "Automatic Detention Without Testing of Farmed Aquatic Products Containing Unapproved Veterinary Drugs. Currently, this import alert is most frequently placed on Chinese and Vietnamese companies for products including tilapia, frog legs, eel and similar aquatic species. In the future, the FDA will continue to blacklist plant names after finding companies with sulforaphane in their aquatic products. The regulation of aquaculture drugs in China is mainly achieved by banning certain chemicals. For example, China bans more than 40 chemicals such as Fonofos, Sulfathiazolum ST, Norsultazo, Benzine hexachloride (BHC), Benzem, bexachloridge,(HCH) , Sulfaguanidine for use in aquatic products and allows drugs such as formalin to be used in certain specific aquatic products, like shrimp and fish eggs (X. Liu, 2014). In contrast, the U.S. attitude toward chemicals used in aquatic products is that unapproved animal drugs, meaning new animal drugs that do not have legal marketing status, are not allowed to be used. The FDA's Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation (ONADE) is working with other government agencies and 162 aquaculture associations to analyze the effective drugs that can be used by the aquaculture industry (CVM, 2020) All FDA-approved animal drugs have a New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA). Compared with China's aquatic product safety standards, not every standard in the U.S. is stricter than China's. For example, the maximum residue limit for oxytetracycline is 0.1 mg/kg in China, but 2 mg/kg in the U.S. China's residue limits for chlortetracycline and tetracycline are also stricter than those in the U.S. For chlordane, China and the U.S. standards are the same for not more than 0.3 mg/kg. It is important to note that China currently has few standards for maximum limits, while the U.S. has more than a dozen clearly defined pesticide chemicals, such as flumioxazin limit of 0.3 mg/kg, sulfadimethoxine limit of 0.1 mg/kg, chlormequat chloride limit of 30 mg/kg, etc. (H. Liu, 2014). The maximum limits for imidacloprid in Codex, China and the European Union are higher than the U.S. standards, which may cause obstacles to the trade of related aquatic products. In terms of heavy metal residue limits, China's national standards are basically consistent with China's major export markets. For some heavy metal residue limit requirements are stricter than the international level, such as cadmium metal. However, some heavy metals have no limit standards, such as arsenic and mercury. The U.S. heavy metal limit standards are characterized by very detailed regulations involving specific species of aquatic products. China 163 has no detailed provisions in national standards, but industry standards for some heavy metal residue limits for specific species have detailed requirements. The legal effect of industry standards and implementation is not as effective as the national standards. 5.10.3 Safety Issues In the import refusals about "filth", mainly the product contains contaminants, foreign matter, and impurities, etc. In China's exports of aquatic products, the FDA has detected the presence of “filth” like hair, flies, insects, and feathers. In some canned aquatic products, the FDA has found impurities such as metal wires and broken needle tips. In addition, the substandard production, processing, packaging, and storage environment, the product is contaminated or decomposed, are also the reasons that the FDA detected the "filth". All of these have a great adverse impact on our aquatic products exported to the United States. From 2006 to 2012, China's exports of U.S. aquatic products were blocked for a variety of reasons, including pesticide and veterinary drug residues (576 batches), substandard quality (517 batches), excessive food additives (270 batches), microbial contamination (234 batches), and inappropriate labeling (117 batches), which occupied the top five reasons for China's blockage (X. Liu, 2014). 164 In 2016, the FDA automatically detained a total of 98 Chinese food products, including 29 aquatic products, accounting for 30%, mainly due to the detection of antibiotics, antimicrobial agents, and other drug residue substances, including nitrofuran and sulfonamide, and the presence of microorganisms such as Salmonella exceeding the standard (Gao, 2017). There have been repeated cases of Chinese aquatic products companies being rejected by the U.S. because of poor HACCP systems. In August 2011, three batches of crab meat products exported to the U.S. by Fujian Aquatic Products Co., Ltd. were rejected due to non-compliance with aquatic products HACCP regulations. Frozen tilapia and frozen tilapia fillets exported to the U.S. by Fujian Longhai Green Aquatic Food Co., Ltd. in March 2012 and January 2013 were again rejected because they did not meet HACCP requirements. (H. Liu, 2014). It can be seen that the implementation of the HACCP system in Chinese aquatic products enterprises is not enough to implement. Chinese aquatic products are also facing a variety of problems such as serious water pollution, lack of safety awareness among farmers, and lack of implementation of aquatic product standardization. The main causes of aquaculture pollution in China are environmental pollution and wastewater discharge. These two causes increase the content of heavy metal elements such as mercury, lead, arsenic, and cadmium in the water and enter the aquatic products through the water source and food chain, causing the heavy metals in the aquatic products to exceed the standard. 165 From Figure 5.8, we can find that from 2002 to 2007, as China's exports to the United States increased, the number of import alerts issued by the FDA also became more (Yin et al., 2018). From 2007 to 2009, the number of fish and seafood rejected by the FDA decreased briefly, but then reached an all-time high of 405 in 2011. Since 2011, although China's exports of seafood to the U.S. are increasing, the number of FDA rejections is decreasing. From 2015 to 2018, the FDA rejected an average of 234 seafoods from China per year. 2019 and 2020 have seen a decrease in seafood imports into the U.S. due to Covid-19 and the trade war, which has also led to a decrease in the number of rejections. The 2017 data show that the unqualified rate of sampling items of aquatic products in China, in descending order, is total arsenic (10%), excessive colony (4.97%), excessive aluminum (2.54%), excessive coliform (0.93%), sulfur dioxide (0.66%), and the unqualified rate of other sampling items are below 0.6% (Yin et al., 2018). In Figure 5.9, we mainly compare the qualification rate of aquatic products and major agricultural products (including tea, fruits, vegetables, livestock, poultry, and aquatic products) in China from 2013 to 2017. The data of the passing rate are from the daily sampling and monitoring of the Ministry of Agriculture. Since sampling and monitoring are only for large farmers' markets, data on small markets are lacking. As shown in Figure 5.9, the qualification rates of major agricultural products between 2013 and 2017 are significantly higher than the qualification rates of aquatic products. Except for 2014, the qualification 166 rates for routine monitoring of agricultural products are higher than 97%. While the aquatic products pass rate has not only been lower than 97%, but also only higher than 96% in 2017. It can be seen that the qualified rate of routine monitoring of aquatic products and the qualified rate of major agricultural products there is a large gap. 167 Figure 5.8 Import refusals related to seafood from China, 2002 to Mar 2021. Note. Data is from the FDA import refusals Dashboard: https://datadashboard.fda.gov/ora/cd/imprefusals.htm 168 Figure 5.9 Qualification rate of aquatic animals and main agricultural products in China, 2013 to 2017. Note. The data are adapted from Introduction to 2018 China Development Report on Food Safety by Yin et al. 169 5.11 Vegetables and Fruits The Chinese Ministry of Agriculture monitors the quality of the large varieties of vegetables produced and consumed. For the time being, no data are available for bulk vegetable varieties sold at home or in small markets and for vegetable varieties produced and consumed only in some areas. The results of MOA's monitoring of agricultural residues such as methamidophos in vegetables showed that the monitoring pass rate for vegetables in 2017 was 97%, which is 0.2% higher than in 2016 (Figure 5.10)(Yin et al., 2018). Since 2005, China's vegetable testing pass rate, although occasionally fluctuating, is generally in an upward trend, and the situation of excessive pesticide residues has improved significantly. Moreover, since 2008, China's vegetable products sampling pass rate has remained above 96% for 10 consecutive years, with a peak in 2012 (Figure 5.10). 170 Figure 5.10 Pesticide residue index of vegetables in China, by qualification rate, 2005 to 2017. Note. The data are adapted from Introduction to 2018 China Development Report on Food Safety by Yin et al. 171 Fresh fruits and vegetables are susceptible to browning, decay and microbial contamination during preservation due to strong respiration, water loss and rapid metabolism. To extend the storage time of fruits and vegetables, preservatives are widely used in dried fruits and vegetables. Therefore, effective technology is necessary to extend the shelf life of dried fruits and vegetables (Lou et al., 2017). Sulfites and sulfur dioxide are used extensively as preservatives for fruits and vegetables because of their antioxidant, antibacterial, antifungal and anti- browning properties. According to the US FDA, the maximum residue limit (MRL) for sulfites in food is 10 mg/kg and sulfites cannot be added to products intended to be eaten raw or fresh. (Lou et al., 2017). The Codex Alimentarius Commission allows a maximum level of 50, 1000, and 500 mg/kg for sulfites in surface-treated fresh, and dried fruits and vegetables, respectively. In contrast, the Chinese National Food Safety Standard for Uses of Food Additives (GB 2760-2014) has maximum values of 50, 200, 100, and 350 mg/kg in surface-treated fresh fruit, dried vegetables, pickled vegetables and glazed fruit, respectively. There is, however, no provision in GB 2760-2014 or international standards for the use of sulfites in fresh vegetables. Peng et al. studied sulfur dioxide residues in nine food products (glazed fruits, pickled vegetables, beverages, sugar, soy starch noodles, dehydrated vegetables, aquatic products, meat products and flour products) in Hunan Province, China, and the results showed that the exceedance rate of sulfur 172 dioxide residues in dehydrated vegetables, pickled vegetables and glazed fruits was relatively high. The amount of pesticides used in China is increasing year by year at a rate of 7% to 10%. In leafy vegetables, fruits, herbs, the rate of use of highly toxic pesticides is 34.7% (Yang et al., 2016). Some of the highly toxic pesticides are cheap and effective, and farmers have become accustomed to using highly toxic pesticides, coupled with farmers' eagerness for quick profits, resulting in habitual overdosing of pesticide residues in vegetables. Microbial hazards of fresh agricultural products are difficult to control, and the sources of pollution are extensive. The hazards in the international distribution of fresh agricultural products come from the secondary pollution of the operators in each operation, the pollution of the water source for cleaning vegetables, the microbial hazards of the vegetable processing environment and the microbial hazards generated by the transportation equipment. The results of routine monitoring of pesticide residues such as methamidophos in fruits conducted by the Ministry of Agriculture show that the qualification rate of fruits in 2017 was 98%, an increase of 1.8% compared to 2016, which is the largest increase in the qualification rate of agricultural products monitoring (Figure 5.11). Since 2008, the pass rate of fruit has fluctuated slightly but is generally above 96%. 2017 reached a new peak with an increase of 0.1% from the peak level of 97.9% in 2012. The figure shows that although the level of fruit quality and safety in China is gradually getting better, 173 many food safety problems cannot be detected because of the limitations of monitoring tools, and the results of routine monitoring are not representative of the overall fruit quality. 174 Figure 5.11 Pesticide residue Index of fruits in China, by qualification rate, 2005 to 2017. Note. The data are adapted from Introduction to 2018 China Development Report on Food Safety by Yin et al. 175 As can be seen from Figure 5.12, FDA rejections of vegetables from China peaked at 296 in 2004. Since 2004, there has been a decline in the rejection of vegetables from China. From 2007 to 2010, it has remained at about 120 rejected batches per year. After a brief climb to 240 in 2013 the trend is back on the decline. The overall number of vegetable-related import refusals is significantly lower than that of fishery products. 176 Figure 5.12 FDA import refusals related to vegetables and vegetable products, 2002 to Mar 2021. Note. Data is from the FDA import refusals Dashboard: https://datadashboard.fda.gov/ora/cd/imprefusals.htm 177 Import refusals related to fruits are the least in the three major categories (Figure 5.13). As a whole, from 2002 to 2020, the fruits exported from China were rejected by FDA for more than 100 batches only in 2004,2007,2011,2012,2016,2018, and 2019. In the remaining years, only an average of 75 import refusals per year is about fruits. Although there are fewer import refusals related to fruits than those related to vegetables and aquatic products, the safety and quality issues of fruits still cannot be ignored 178 Figure 5.13 FDA import refusals related to fruits, 2002 to Mar 2021. Note. Data is from the FDA import refusals Dashboard: https://datadashboard.fda.gov/ora/cd/imprefusals.htm 179 5.12 Meat/Poultry 5.12.1 Regulation Bacteria The International Committee on Microbiological Specifications for Foods (ICMSF) stipulates that microbiological criteria for foods consist of five parts: (1) description of the microorganisms and/or their toxins; (2) analytical methods for the detection and quantification of microorganisms; (3) sampling protocols; (4) microbiological limits applicable to foods; and (5) the number of sample units that meet these microbiological limits. (ICMSF, 2021). Different countries have differences in the detection of microbiological items. China on meat food hygiene control standards is mainly GB, SN, NY, and other standards (Ic & Cetinkaya, 2021). GB standard is the national standard, which is the technical requirements that need to be unified nationwide. National standards are codenamed GB and GB/T, which mean mandatory national standards and recommended national standards, respectively. SN Import and export industry standards and NY agricultural standards belong to industry standards. In addition, the announcement issued by the quality inspection, agriculture/food/drug administration is also the main basis for meat hygiene control in China. China's microbiological testing of imported meat is mainly focused on Salmonella, Listeria monocytogenes, E. coli and Staphylococcus aureus and other species. In the limit requirements, no matter what kind of meat is not 180 allowed to be detected. Overall, China's microbiological testing of imported meat is more stringent than in Europe and the United States. However, China's pork microbial limit standards for pathogenic bacteria only require that not be detectable, there is no provision for sampling programs and other content. Compared with the United States there is a gap. Detection of pathogenic bacteria without defining the unit of measurement is not scientific, any experiment has a specific object, sampling volume, the specific scope of the resulting experimental results. Therefore, reference can be made to the U.S. standard for the corresponding improvement. The USDA meat safety control system requires that all slaughter plants must be tested for E. coli and Salmonella and meet the required indicators, and any slaughter plant that fails to meet the standards is required to take the necessary improvements and remedial measures, and in serious cases is ordered to stop production. The U.S. processing control standards for pork products specify a low limit of 10 cfu/cm² for Escherichia coli and a high limit of 10,000 cfu/cm² and specify the number of samples tested, as well as the maximum number of samples allowed between the low and high limits (Cheng, 2014). It can be seen that the U.S. meat safety system for E. coli requirements is relatively strict. 181 Drugs In 2013, a team of researchers from Michigan State University and China found that a variety of drug-resistant bacteria were found in pigs raised on pig farms across China due to the use of antibiotics for livestock (Zhu et al., 2013). Bacterial resistance genes were also found in the soil of agricultural fields near pig farms, possibly transmitted through the use of fertilizers made from pig manure. The research team warns that drug-resistant genes entering human pathogens could trigger infectious diseases that are difficult to treat. Internationally, veterinary drug residues are divided into seven categories, namely β - adrenergic receptor blockers, sedatives, trypanocides, anthelmintics, growth promoters, anthelmintics, and antibiotics. Drugs commonly used in China's livestock breeding include metal trace elements, hormones, vitamins, and antibiotics. The harm of drug residues in food of animal origin has chronic, long-term and cumulative characteristics, so countries around the world have increased the supervision of drug residues in food of animal origin. Ractopamine, like clenbuterol hydrochloride (commonly known as leptin), is a β-adrenergic stimulant and is not approved for use as a veterinary drug in most countries around the world. All β-adrenergic stimulants, including ractopamine, have long been banned in food animals in the EU. In 2002, China also explicitly included ractopamine in the list of drugs banned for use in feed and animal drinking water (Zhang et al., 2019). Currently, only 24 countries in the Americas and Asia Pacific, including the United States, Canada, and Brazil, allow 182 the use of ractopamine in food animals, mainly to accelerate growth and improve leanness in pigs and cattle. Many U.S. companies choose not to add ractopamine to their animal feed in order to increase foreign trade. Take Smithfield Foods, one of the largest pork processors in the U.S., as an example. Prior to its acquisition by WH Group(a food company in China) in 2013, Smithfield Foods used ractopamine as a feed supplement to increase lean meat production (Zhang et al., 2019). The company also launched a "never fed ractopamine" program in hopes that more producers would join them. Many major U.S. meat processors also tend to use stricter regulations than the FDA's guidelines when it comes to the use of antibiotics. Again, Smithfield Foods is used as an example (Smithfield, 2021). Medically important antibiotics are prohibited for growth-promoting purposes under the FDA's 209 and 213 industry guidance. Medically important antibiotics may only be used for the prevention, treatment, and control of animal diseases. Animal-only antibiotics may be used for growth promotion and feed efficiency. Smithfield Foods began strict regulation of antibiotic use before the FDA's 209 and 213 industry guidance became mandatory. They also provide assistance to contract farms to better implement the FDA guidelines. See the following table for details. 183 Table 5.5 Comparison of the U.S. and China controls with respect to area of animal health concern. Aspect United States China Hormone treated beef Growth-promoting hormones are used extensively in beef production in the United States and have been authorized since the 1950s. The FDA has approved the use of about 30 growth promoting hormones such as estradiol, progesterone, testosterone, trenbolone acetate and zeranol. China has banned the use of hormone growth promoters (HGPs) in beef. Any meat exported to China must be free of synthetic forms or physiological amounts of natural estradiol. There may be instances of improper use of feed ingredients or feed additives or use of veterinary drugs during animal feeding/production in local China, resulting in hormone residues. Hormone treated pork/poultry No hormone implants are approved for growth purposes in pigs or poultry. No hormone implants are approved for growth purposes in pigs or poultry. Livestock antibiotics Non-therapeutic use of antibiotics is allowed. It is estimated that 80 percent of antibiotics in the United States are used on farm animals. They are used to help animals avoid disease, but the drugs also add weight to the animals. Antibiotics such as fluoroquinolones, cephalosporins, and chlortetracycline are basically banned from use in food animals. The animal farming industry in China relies heavily on the use of antibiotics, which are authorized as veterinary drugs for the treatment of animal diseases and also as a growth promoter. However, the use of antibiotics and their management in animal farming is not regulated in China. 184 Ractopamine Ractopamine is used as a feed additive to speed up pig weight gain by improving feed efficiency, and it also increases lean muscle mass in fattening pigs. It is permitted in the United States, where it is estimated that 60 to 80 percent of pigs are fed it. The use of all beta agonists (including ractopamine) was banned in 2002. The manufacture and sale of ractopamine was prohibited in China in 2011. Poultry treated with antimicrobial rinses In the United States, it is common practice to wash chickens in a chlorine bath. Chlorine- treated chicken removes salmonella and other pathogens that cause food poisoning. Poultry slaughterhouses use water cooling to cool chicken carcasses to about 7°C. Both large and small markets do not use chlorine baths to disinfect poultry. 185 5.12.2 Safety issues In recent years, the safety of meat food has attracted unprecedented attention. Global outbreaks of major animal epidemics and meat food safety events have created psychological panic. In Europe, Belgium, the Netherlands, France, and Germany, there have been incidents of dioxin contamination resulting in livestock and poultry meat products containing high concentrations of dioxin (Anyshchenko & Yarnold, 2020). "Mad cow disease", "streptococcus", swine flu and the global high alert H7N9 avian influenza since 2013, as well as the repeated exposure of "Ractopamine" poisoning in China, have sparked a global discussion. Due to the impact of animal epidemics and international political factors, China has strict restrictions on the source of meat and the variety of meat. Among them, the United States and Canada have both poultry by-products and pig by-products imports, and Australia and New Zealand have beef and lamb imports, which are the main multi-product species trading countries (UN COMTRADE). The reason for the surge in China's meat trade with the EU in recent years is mainly due to the use of ractopamine allowed in China's traditional trading countries, the United States and Canada, resulting in a high rate of unqualified detections of pig by-products imported from these two countries. In 2007, Guangdong's inspection and quarantine department had detected ractopamine (a veterinary drug) residue in two consecutive frozen pork kidney imports from the United States and frozen pork chops imported from 186 Canada (China Quality, 2007). This has forced Chinese importers to shift their targets to EU countries where ractopamine use is also banned. Due to the many changes in the websites that publish the results of imported food testing, and the fact that some of the data is not publicly available, we are unable to grasp the long-time span and specific data. The analysis below mainly uses meat inspection and quarantine data imported from Europe, America, Australia and other countries at Shanghai port for 7 years from 2006 to 2012. Shanghai port accounts for one-third of China's total import and export volume. The main problems with the hygiene of meat imported into Shanghai port are sensory quarantine failure and physical and chemical testing failure. Sensory quarantine failure primarily includes labeling that does not comply with the regulations, the goods containing hard rod hair, yellow skin and other foreign objects exceeding the standard, corruption and deterioration, entrapped unlicensed products. The physical and chemical testing failure mainly includes pesticides and veterinary drugs, pathogenic microorganisms, heavy metals and other toxic and harmful substances content exceeds the standard. Unqualified labeling is the most common problem with imported meat at the Shanghai port, accounting for more than 99% of failed batches of sensory quarantine each year. From the data of recent years, all trading countries and all meat types have this problem. As can be seen from Figure 5.14, the number of meats from the U.S. rejected by the Shanghai port due to labeling failure is 187 increasing year by year, and in 2012, it reached a record high of 950 batches. Labeling failure has become a key factor in limiting the qualification rate of incoming meat. 188 Figure 5.14 Number of unqualified labels for meats imported from the U.S. at Shanghai Port, 2006 to 2012. Note. The data is adapted from Health Situation Analysis and Quarantine Supervision Countermeasures of Imported Meat in Shanghai Port by Cheng et al., 2014 189 From 2006 to 2012, the toxic and harmful substances detected in imported meat at Shanghai ports mainly include Salmonella, Staphylococcus aureus and Listeria monocytogenes pathogenic microorganisms, heavy metal cadmium residues and veterinary drug residues (ractopamine) (Table 5.6)(Cheng et al., 2014). In the meat species, pork detected the most quality problems, reaching 80 batches, accounting for 93% of the failed batches. The main reasons for failure were the detection of ractopamine residues and excessive levels of heavy metal cadmium. U.S. meat hygiene problems are mainly detected in pork products' ractopamine residues, which is closely related to its government policy of allowing the use of this drug. 190 Table 5.6 Number of meats imported from the U.S. unqualified by physical and chemical inspection at Shanghai Port. Note. The data is adapted from Health Situation Analysis and Quarantine Supervision Countermeasures of Imported Meat in Shanghai Port by Cheng et al., 2014 Poultry (Batches) Pork (Batches) Ractopamine / 69 Heavy metal cadmium / 7 Salmonella 2 3 Listeria monocytogenes / 1 Staphylococcus aureus 2 / 191 5.13 Grains/Soybean As China's trade with the U.S. in grain and soybeans has grown exponentially, weed invasion has become a serious threat to China's agroforestry production and ecological security. As the world's largest grain importer, China spends a lot of human and financial resources every year to prevent and control invasive pests. In order to promote effective international trade in plants and plant products and to reduce important incoming and outgoing outbreaks, China and the U.S. have signed memoranda or protocols for related products, such as grain, wood and wood packaging, specifying treatment methods, agents and timing, and regulating requirements for treatment certificates. As the total demand for vegetable oil in China continues to grow, domestic soybean production is far from enough to meet domestic needs. Soybean imports are increasing year by year, and China has become one of the major importers of soybeans. Therefore, the quality of imported soybeans is an issue of concern. The quality of imported soybeans directly affects the oil yield of soybeans and the quality of soybean oil, which is related to the processing costs and economic interests of food companies. The quality of imported soybeans will also have an indirect impact on the quality of soybean meal, which is related to the interests of feed processing enterprises. As a net importer of soybeans, China imports more than 80% of its total soybean imports from the U.S. and Brazil each year. Most of the soybeans imported into China are Genetically Modified Organisms (GMOs) and are mainly 192 used for oil extraction. Soybean meal, a by-product of the crushing process, is used as a feed ingredient for feed processors. Unlike imported soybeans, most of China's soybeans are non-GMO and are mainly used for food processing, such as tofu, soy products and soy milk. The main quality and safety problems found with soybeans imported from the U.S. include phytophthora problems, safety and hygiene problems, quality substandard problems, and undeclared problems with genetically modified soybeans (Thakur & Hurburgh, 2007). To match the management of genetically modified agricultural products, in 2004 the AQSIQ announced the "Import Inspection and Quarantine Management Measures for Genetically Modified Products” (MOA, 2017). The measures stipulate that genetically modified products approved by genetic testing are allowed to enter the country. If one of the following conditions, the inspection and quarantine agencies will notify the owners or their agent to do the return or destruction: (a) declared as genetically modified products, but the detection result of its genetic components and approval documents do not match; (b) declared as non-genetically modified products, but the test contains genetically modified components. Imported U.S. soybeans are often found with fake sorghum, black sorghum, ragweed, fake celandine and other quarantine noxious weeds. These weeds are not distributed in China, and once introduced, can pose a threat to China's agricultural production and ecological security. Some of these weed seeds also contain toxins that can harm the health of humans and animals. In 193 addition, imported U.S. soybeans have repeatedly been detected with soil clods. Soybean disease that harms soybean production has been isolated from the soil clods. In February 2007, a shipment of U.S. soybeans was found to be mixed with red seed-coated soybeans, which were tested to contain two pesticide ingredients, methomyl and nimethomyl, posing a great risk to Chinese consumers' food safety. In the same year, imported U.S. soybeans were also found to have protein content and oil content in some batches that did not meet contractual requirements, with heat damage rates and impurity content higher than contractual requirements (Zhao et al., 2014). From 2008 to 2016, the quarantine pests intercepted at China's ports increased rapidly with the increase in trade between China and the U.S., and the number began to fall in 2017 (Y. Liu & Dai, 2020). Soybeans, grain, wood, and wood packaging are at the highest risk of carrying pests of agricultural products. In the interception of agricultural products containing pests from the United States, the most intercepted batches are weeds carried in soybeans and grains, a total of 79 species, 90,618 batches. 5.14 Fungal Toxins According to the Food and Agriculture Organization of the United Nations (FAO), about 25% of the world's food is contaminated with fungal toxins each year, and about 2% of crops are so contaminated that they lose their value for 194 use (FAO, 2021c). FAO and Joint FAO/WHO Expert Committee on Food and Additives (JECFA) have concluded through several meetings that aflatoxin (a fungal toxin) is a strong carcinogen that may cause liver cancer in humans. However, due to the lack of strong data on aflatoxin causing liver cancer in humans, no maximum tolerable intake of aflatoxin has been proposed. Similarly, the carcinogenesis of Ochratoxin A and Deoxynivalenol is not known. Table 5.7 shows the limits of some fungal toxins in grain published by the Codex Alimentarius Commission (CAC), the United States, and China. Both CAC and the U.S. have limits on the total amount of aflatoxin B1, B2, G1, and G2, with the U.S. standards being slightly more lenient than CAC. While China has done different aflatoxin B1 limits for different grain types. China's limits for Ochratoxin A in grain are consistent with the CAC, whereas the U.S. has no regulations for this. The FDA considered that since processing significantly reduces the amount of Deoxynivalenol in the final product of wheat, the FDA only proposed a recommended limit of 1,000 μg/kg for Deoxynivalenol in wheat products. While China has made the same limit for wheat. 195 Table 5.7 Limits of fungal toxins in different food categories from CAC, the U.S., and China. Food category Limit of fungal toxins μg/kg Aflatoxin B1 Aflatoxin (B1/B2/G1/G2) Deoxynivalenol A Ochratoxin CAC Peanut / 15 / / The U.S. All food (exclude milk) / 20 / / Wheat products / 20 1000 / China Corn/corn products 20 / 1000 / Wheat/wheat products 5 / 1000 5 Vegetable oil 20 / / / 196 5.15 Conclusion Traditionally, policy implementation has emphasized operational certainty and procedural fairness. From a governance perspective, strict interpretation of regulations and uniform requirements for compliance are closely linked to regulatory effectiveness. In contrast to the traditional approach, the "new governance" paradigm, that is, an emphasis on flexible regulatory interpretation and penalty allocation, has also received attention. At the same time, studies have found that citizens, non-governmental organizations (NGOs), and civil society have an increasing influence on food regulation. These different approaches to regulation are not applicable to every political institutional environment and are particularly unsuitable for countries with low levels of social trust in government (Yee & Liu, 2021). From the perspective of policy implementation described above, there are still major problems with food safety transparency in China. Foodborne disease disclosure and regulation does not effectively utilize NGOs and citizens. While the U.S. has an easy-to-use web page for foodborne illness reporting, China needs to make these resources more accessible to citizens without the psychological burden of reporting food safety issues or illnesses. Based on the analysis of the surveillance, information disclosure, and data of foodborne disease outbreaks in the United States, we found that early identification, surveillance, and early warning of foodborne disease and identification of specific disease trends can effectively reduce disease incidence 197 and mortality. There is a large gap between the Chinese surveillance system and the United States in terms of attribution analysis of foodborne disease surveillance data, traceability investigations, early warning prediction and disease burden studies, and standardization of gene-wide traceability investigation techniques. Second, China is still a long way from the U.S. level in the integrated use of foodborne disease epidemiological investigation, laboratory testing, and traceability analysis technologies. What China has is often a carrier in the transmission pathway, but it cannot achieve food chain investigation, nor can it prove the role and contribution of contaminated food in outbreaks and epidemics, which has become a "bottleneck" for China to achieve foodborne disease control. According to the U.S. experience in foodborne disease control, China needs to improve its foodborne disease reporting platform and enhance the public's basic understanding of foodborne disease symptoms and treatments. Promote the building of physicians, laboratory personnel, and clinical laboratories. Improve the speed of genotyping and data analysis to shorten outbreak identification and response time. Good communication and information sharing between public health departments, clinical hospitals, and agricultural departments need to be established. By analyzing the standards and safety status of specific food types in China, the United States, and international organizations, we found many similarities and differences between the three. In terms of food safety standards, 198 China is stricter than the U.S. in both the categories of prohibited substances and prohibited uses and is closer to the international organizations. However, some of the substances banned in China were selected due to pressure from other countries to avoid technical trade measures and lacked the necessary scientific basis. Testing technology is the key to determining a country's level of food safety. Compared to the United States, China has a very weak base of research, instruments, and technicians for food safety testing methods. In the case of pesticide residues, veterinary drug residues, and additives in food, the common international practice is to sample and quickly test products according to certain specifications. Therefore, the identification of quantitative testing methods and procedures and the study of rapid screening kits are urgent issues in China. Improving the testing technology is the key to solving trade disputes, arbitrations, and government actions in China and the United States. HACCP and risk analysis are recognized and recommended by international organizations such as FAO/WHO and CAC as important tools for managing food safety and setting safety standards and are commonly used in the United States. Compared to the U.S., China has less systematic research in this area, is not widely used, and cannot yet be the basis for policy and standard setting in China. Although the relevant authorities have been promoting the importance of HACCP and risk analysis in recent years, it has never been significantly enhanced for food safety in China because of the difficulty of 199 supervision, the lack of willingness of companies, and the high cost of use. Thus, resolving the conflict between cost and trade advantage is an important issue for the development of food safety in China. 200 Chapter 6 Education 6.1 Introduction With the development of the global economy, the food industry has grown considerably, and the development and technological progress of the food industry require a large number of professionals involved in the education, management, research, production, and marketing of food. Therefore, food science professional education is increasingly important. The Food Science major has the characteristics of combining science and technology, covering the basic theories and knowledge of chemistry, biology, mechanics and engineering and other disciplines. The curriculum of food science integrates food storage and processing, food analysis and testing, food nutrition and hygiene, food engineering design, etc. Students have the ability of food production management, product development, quality and safety control, food engineering design, and so on. Graduated students can engage in food science research, food industry supervision, food engineering design and food production enterprise management, and other related work. To better compare the current situation and development of the food field in China and the United States, it is necessary to pay attention to the dynamics and trends of food science professional education in China and the United States. By comparing the education methods, curriculum, and course contents in 201 China and the United States, we may be able to get some explanations for the different development processes of food science and safety in China and the United States. 6.2 Food Science Undergraduate Program in China and the United States According to incomplete statistics, there are over 140 U.S. schools that offer Food Science and Technology majors, and about 200 universities offer Food Science programs in China (Tu & Ma, 2013). Food Science and Technology education in the U.S. is a generalist training model, with the goal of producing blanket engineers who can be generalists in their subject areas. American universities mainly impart basic knowledge and skills to students, and train them to have the basic knowledge, basic skills and comprehensive literacy for a future career as an engineer. In the United States, minimum standards for education in undergraduate programs in Food Science and Technology have been established by the Institute of Food Technologists (IFT), an international, non-profit organization that sets standards to assess whether food graduates have the skills to work in the food industry (IFT, 2021b). The IFT established the Higher Education Review Board (HERB) to assist programs by assessing learning outcomes, improving excellence in Food Science education, and supporting programs in gaining IFT approval. The HERB carries out a review of approved projects every five years 202 and revises the IFT approval guidelines at least once every ten years. Currently, there are a total of 80 IFT-approved Food Science and technology programs worldwide, of which 42 are in the United States and 10 are in China (IFT, 2021a). The IFT reviews Food Science and Technology programs at institutions of higher education in three main areas: facilities, teaching faculty, and, most importantly, curriculum content (IFT, 2021a). IFT has strict and specific rules for each area and aims to provide students with a thorough understanding of not only the core content of Food Science, but also the communication and leadership skills. Unlike the United States, the vast majority of Chinese universities are publicly funded. All public universities are governed by the same standards. The Ministry of Education (MOE) is responsible for approving the establishment of majors in Chinese universities (MOE, 2021). The MOE, as a component of the State Council in charge of education and language, is responsible for researching and formulating policies on education. The MOE also manages the planning and use of national education funds. The curriculum design, graduation standards, admission requirements, and use of funds for each program at Chinese universities are all required to be reviewed and approved by the MOE. Therefore, all Food Science programs in Chinese universities follow the same standards, which are set by the MOE. Meanwhile, the MOE needs to make divisions for the majors (MOE, 2021). A Tier 1 program refers to the classification of programs in universities. A Tier 1 203 program is a major category, and a Tier 2 program is a subcategory of that category. For example, Food Science and Engineering is a Tier 1 program, similar to a “Major” in the United States, while Food Science and Safety is a Tier 2 program, similar to “Track” or “Concentration” in the U.S. Although the standards are the same for each program at Chinese universities, there are still rankings for each university. Every four years, the MOE evaluates the ranking of Tier 1 programs based on four dimensions: faculty and resources, quality of student development, level of scientific research, and social contribution (MOE, 2021). Faculty and resources include faculty titles (professor, assistant professor, academician, etc.), the number of professors, and the rank and number of laboratories (national, provincial, key laboratories). Student development is assessed in terms of course quality, international exchange opportunities, quality of the thesis, employment, etc. The level of scientific research refers to the quality and quantity of published academic papers, patents, awards received, etc. Social contribution references the influence, ethics, and international reputation of the discipline. In 2017, the MOE made an assessment for the Food Science and Technology programs of 79 universities that voluntarily participated based on the above four dimensions, and the top five schools are shown in Table 6.1 (China Education, 2017). Of the top 10 Food Science programs rated by the DOE, seven are approved by the IFT. 204 Table 6.1 Top 15 Universities in China that offer Food Science and Technology Program undergraduate programs rated by the Chinese Ministry of Education. **The Chinese Ministry of Education has 9 grades for undergraduate majors, with the highest being A+ and the lowest being C-. The table lists the highest four grades, which is the TOP 15. Name Rating IFT-Approved China Agricultural University A＋ √ JiangNan University A＋ √ NanChang University A NanJing Agricultural University A﹣ √ ZheJiang University A﹣ √ HuaZhong Agricultural University A﹣ √ South China University of Technology A﹣ √ TianJin University of Science and Technology B＋ √ Dalian Polytechnic University B＋ Northeast Agricultural University B＋ Shanghai Ocean University B＋ √ JiangSu University B＋ China Ocean University B＋ South China Agricultural University B＋ Northwest A & F University B＋ 205 Unlike Chinese university rankings, which are conducted by national departments, the United States does not have a unique and official website or agency that rates and ranks universities. Since there are not only websites, but also newspapers, institutions, individual users and many other subjects that rank universities in the U.S., we choose to compare the rankings made by U.S. News & World Report, which is more familiar to Chinese people. U.S. News World University Rankings, Times Higher Education World University Rankings, QS World University Rankings, and Shanghai Soft Science World University Rankings are the four most authoritative world university rankings. U.S. News & World Report is a media company that has been conducting research and rankings for various industries such as education, career, travel, etc. since it was founded as a news magazine in 1933 (US NEWS, 2021). The modern college rankings were published by U.S. News & World Report in 1983. The original intent of the college rankings was to evaluate the quality and influence of colleges and universities. Different from the Chinese Ministry of Education, which updates its university rankings every four years, U.S. News ranks U.S. and world universities every year. U.S. News evaluates universities on nine dimensions, which are graduation and retention rates, social mobility, graduation rate performance, undergraduate academic reputation, faculty resources, student selectivity for the class, financial resources per student, average alumni giving rate, graduate 206 indebtedness. Compared to China MOE, U.S. News places a lot of weight on student graduation rates, which account for 22% of the overall weight in evaluating universities. For Chinese universities, the vast majority of students graduate in their fourth year, so graduation rates are not a factor in evaluating universities. Also, since most Chinese universities are public, student loans and alumni donations are not taken into account as the majority of students' tuition and school funding are allocated by MOE. Like MOE, U.S. News also lists undergraduate academic reputation and teaching resources as very important factors. When the range of choices is different, the results of the ranking can vary greatly. Table 6.2 shows the top 15 national-level universities with the best food science and technology programs and with undergraduate through doctoral degrees, as selected by U.S. News. News. As can be seen from the table, all of the top 15 universities are the IFT HERB-Approved undergraduate programs. 207 Table 6.2 Top 15 National universities in the U.S. that offer Food Science and Technology Undergraduate Programs rated by the U.S. News & World Report. Name Ranking IFT-Approved University of Illinois--Urbana-Champaign 1 √ Cornell University 2 √ Purdue University--West Lafayette 3 √ University of Wisconsin--Madison 4 √ Virginia Tech 5 √ Pennsylvania State University--University Park 6 √ University of Maryland--College Park 7 √ Ohio State University--Columbus 8 √ University of California--Davis 9 √ University of Minnesota--Twin Cities 10 √ North Carolina State University 11 √ University of Florida 12 √ Iowa State University 13 √ Michigan State University 14 √ Rutgers University-New Brunswick 15 √ 208 6.3 Graduation requirements Most U.S. universities require 120 credits for graduation from a Food Science and Technology program, while Chinese universities require 160 to 180 credits for undergraduate students. IFT has no explicit credit requirements for Food Science programs in the U.S while MOE has a minimum requirement of 150 credits for Chinese undergraduates (IFT, 2021b; MOE, 2021). U.S. universities generally assign credits by "university requirements", "college requirements" and "major requirements" (Figure 6.1). The "University requirement" in the United States generally includes courses in the humanities and social sciences. Regardless of whether a student is majoring in liberal arts or science, basic courses in humanities and social sciences are required. For food science programs, the "College requirements" include basic science courses, and the "Major requirements" include food-related science courses. The curriculum of Food Science majors in Chinese universities is divided into three main categories: public basic courses, major courses and practical courses (Figure 6.1). The public basic courses are similar to the " University Requirements" in the United States and include not only humanities and social science courses, but also sports, politics, and basic science courses, which are mandatory for all students entering the university. The "Major course" includes the basic science courses and food-related science courses that are required for the Food Science program. Practical courses include thesis and internship. 209 Figure 6.1 Comparison for curriculum design of Food Science Programs in China and the United States. 210 6.4 Curriculum Comparison In terms of curriculum, American universities emphasize general studies. For example, students whose majors are in science must take two or more courses in humanities and social sciences. To facilitate comparison with the following, Michigan State University (MSU) and South China University of Technology (SCUT) have been chosen as examples. As two schools with a deep partnership, each year a number of SCUT students who complete their second year choose to go on to MSU to complete the Food Science program. For the food science program in MSU, each student is required to take a total of 8 credits of humanities courses, 8 credits of social studies (including economics), and 4 credits of writing courses (Table 6.3). Of these, the writing course is a mandatory requirement for the Food Science program by IFT. These general education courses account for 16.67% of the graduation requirements (a total of 120 credits). 211 Table 6.3 University requirements of Food Science Program in Michigan State University. Source: Michigan State University Food Science Degree Requirements Website https://www.canr.msu.edu/fshn/undergraduate_programs/food_science/food_science_degree_re quirements University Requirements Credits %（out of 120） Required by IFT Arts & Humanities 8 6.67% Social, Behavioral, and Economic Sciences 8 6.67% Writing 4 3.33% √ Total 20 16.67% 212 The distribution of graduation requirements at the University of Minnesota- Twin Cities (UMN) is roughly the same as at MSU, where the University Requirements section is called General Requirements at UMN (Table 6.4). Unlike MSU, all UMN students are required to take one biology course with lab and one physics course with lab, in addition to humanities, social science, history, and literature courses. However, new General Requirements will be implemented for students admitted after the Fall 2021 semester. The total number of general credits has been reduced from 23 to 15, giving students more freedom to choose the classes they want to take. Also, Physics(4 credits) and Biology(4 credits) with labs have been removed and replaced with Technology and Society(3 credits). 213 Table 6.4 General requirements before and after Fall 2021 of Food Science Program at University of Minnesota, Twin Cities. Source: the University of Minnesota, Twin Cities University Catalogs of Food Science B.S. Website https://onestop2.umn.edu/pcas/viewCatalogProgram.do?programID=271&campus=UMNTC General Requirements Credit s % Required by IFT Arts/Humanities 3 2.50% Biological Sciences with Lab 4 3.33% √ Historical Perspectives 3 2.50% Literature 3 2.50% Mathematical Thinking 3 2.50% Physical Sciences with Lab 4 3.33% √ Social Sciences 3 2.50% Total 23 19.17 % General Requirements After Fall 2021 Race, Power, and Justice in the United States(Required theme) 3 2.5% Civic Life and Ethics 3 2.5% The Environment 3 2.5% Global Perspectives 3 2.5% Technology and Society 3 2.5% √ Total 15 12.5% 214 Unlike American universities where students can change majors after one year of study (except for a few majors), Chinese universities hardly allow students to change majors across colleges, and it is very difficult to change majors within the same college. As a result, all students in Chinese universities take classes that place a lot of emphasis on the fundamentals of science. For example, at the South China University of Technology (SCUT), which is approved by both IFT and MOE, calculus, linear algebra, statistics, physics, and programming are classes that are required for all students (Table 6.5) (SCUT, 2021). In contrast to American universities, China does not emphasize social science education, and only history and politics are required as liberal arts courses. These required courses represent 39.41% of the graduation requirements and are required by the MOE for the Food Science program, with the exception of the writing course (Table 6.5). At the same time, in order to align with international standards, almost all Chinese universities put English as a required subject and generally require two levels of classes. 215 Table 6.5 General basic courses of Food Science Program in South China University of Technology. Source: South China University of Technology Food Science Program Graduation Requirements Website http://www2.scut.edu.cn/sp/ General Basic Courses Credits %（out of 170） Required by the MOE Cultivation of Thought and Morals & Fundamental of Law 2.5 1.47% √ Skeleton of Chinese Modern History 2.5 1.47% √ Analysis of the Situation & Policy 9 5.29% √ English 6 3.53% √ Intro to computer programming 3 1.76% √ PE(4 courses, same level) 6 3.53% √ Calculus 9 5.29% √ Linear Algebra & Statistics 6 3.53% √ Physics 8 4.71% √ Engineering Drafting 5 2.94% √ Humanities & Social Science 6 3.53% √ Writing & Oral Communication 4 2.35% Total 67 39.41% 216 Major courses in the U.S. Food Science program are generally scheduled in the third and fourth academic years. During the student's freshman and sophomore years, they take the major-related basic courses required by the college, such as chemistry, biology, microbiology, mathematics, and physics (Table 6.6). These foundation courses account for one-fifth of all credits. The high-level major required courses include knowledge of all aspects of food-related science. Although the Introduction to Food Science, Seminar, and Career Planning classes are not required by IFT, they provide a good explanation of the major and depict career prospects for students who want to work with food (Table 6.6). As MSU offers four directions of Food Science programs, we selected the Technology Track, which has the largest number of students and is the most similar to the Chinese Food Science program, for comparison. As Table 6.6 shows, the Technology Track emphasizes science courses like chemistry, biochemistry, quality, and statistics. The Technology Track requirement can be met by adding any 9 credits of Food Science-related courses. 217 Table 6.6 College and major requirements of Food Science Program in Michigan State University.Source: Michigan State University Food Science Degree Requirements Websitehttps://www.canr.msu.edu/fshn/undergraduate_programs/food_science/food_science_de gree_requirements College Requirements Credits %（out of 120） Required by IFT Cells and Molecular Biology 3 2.50% √ Chemistry (general & inorganic) with Lab 9 7.50% √ Microbiology 3 2.50% √ Economics 3 2.50% Physics 3 2.50% √ Math 3 2.50% √ Subtotal 24 20.00% Major Requirements Food Engineering 3 2.50% √ Principles of Food 3 2.50% Career Planning 1 0.83% Sensory Assessment of Foods 3 2.50% √ Food Processing with Lab 9 7.50% √ Food Chemistry with Lab 4 3.33% √ Seminar in Food Science 1 0.83% Food Microbiology with Lab 5 4.17% √ HACCP Training and Certification 1 0.83% √ Nutrition with Lab 6 5.00% √ Food Product Development 3 2.50% Subtotal 39 32.50% Concentration (Technology Track) Organic Chemistry with Lab 4 3.33% √ Biochemistry 4 3.33% √ Quality Assurance 2 1.67% √ Statistical Methods 4 3.33% √ Electives 9 7.50% Subtotal 23 19.17% Total 86 71.67% 218 Different from MSU's Food Science and Technology program, which is divided into four tracks, UMN only divides Food Science into two categories (Plan A for IFT approved, and Plan B for a minor option). Therefore, we have chosen the more representative Plan A direction in Table 6.7. Overall, the required credits within the major for UMN are 75 to 89 and follow the IFT requirements for the program. UMN has fewer electives to choose from within the major, allowing students to explore more possibilities and learn more about other fields. 219 Table 6.7 Program and sub-plan requirements of Food Science Program at the University of Minnesota, Twin Cities. https://onestop2.umn.edu/pcas/viewCatalogProgram.do?programID=271&campus=UMNTC Program Requirements Credits % Required by IFT General Biology with Lab 4 3.33% √ Chemical principles with Lab 8 6.67% √ Statistical Analysis 4 3.33% √ Math 4 3.33% √ Physics 5 4.17% √ Biochemistry 3 2.50% √ Subtotal 28 23.33% Program Sub-plans (Plan A) Requirements Organic Chemistry with Lab 10 8.33% √ Engineering Principles for Biological Scientists 4 3.33% Introduction to Food Science 3 2.50% Food Fermentations and Biotechnology 2 1.67% Molecular Biology for Applied Scientists 1 0.83% √ Food Quality 3 2.50% √ Food Analysis 4 3.33% Food Processing Operations 3 2.50% √ Ingredient Functionality and Applications in Food 2 1.67% Food Chemistry and Functional Foods 3 2.50% √ Sensory Evaluation of Food Quality 2 1.67% √ Principles of Nutrition 3 2.50% √ Introductory Microbiology 4 3.33% √ Introduction to Public Speaking 4 3.33% √ Technical and Professional Writing 3 2.50% √ Subtotal 51 42.50% Total 79 65.83% 220 Compared to U.S. universities, where College Requirements and Major Requirements together account for 71.67% of the credits, less than half of the courses in Food Science and Technology programs at Chinese universities are food specialty courses (Table 6.8). Since the major requirements and assessment criteria for Food Science and Technology published by MOE in 2011 refer to the IFT 2001 and 2011 guidelines, the major curriculum for the Food Science and Technology program in China is extremely similar to that of the United States. Unlike U.S. universities that place a high value on practical work, Food Science and Technology programs in China do not have enough laboratory classes. For example, food chemistry, food microbiology, and nutrition labs, which require a deeper understanding of knowledge through experimentation, are not mandated by MOE in China. 221 Table 6.8 Major core courses of Food Science Program in South China University of Technology. Source: South China University of Technology Food Science Program Graduation Requirements Website http://www2.scut.edu.cn/sp/ Major Core Courses Credits %（out of 170） Required by the MOE Chemistry (inorganic, organic & analytical) with lab 10 5.88% √ Physical Chemistry 4 2.35% √ Electrical Engineering & Mechanical Design 7.5 4.41% √ Chemical Engineering 6.5 3.82% √ Intro to Food Science 1 0.59% Biology 3.5 2.06% √ Food Microbiology 3.5 2.06% √ Food Chemistry 2 1.18% √ Nutrition 1.5 0.88% √ Food Biochemistry 4.5 2.65% √ Food Toxicology 1.5 0.88% Food Analysis 3 1.76% √ Food Processing & Safety Control 12.5 7.35% √ Electives 12 7.06% √ Total 73 42.94% 222 After completing a total of 140 credits in General Basic Courses (67 credits) and Major Core Courses(73 credits), Chinese undergraduates are required to complete a thesis(12 credits), internship(12 credits), and extracurricular activities(6 credits) in order to receive a diploma in Food Science and Technology (Table 6.9). The thesis usually requires students to find their own project and mentor of interest, and they can graduate in their final year after passing the defense. The internship program is arranged by the school, and students will receive credit for completing the required number of hours. Activity credit is given for active participation in school events, such as speech contests and volunteering, and is earned when the requirements are met. 223 Table 6.9 Training courses of Food Science Program in South China University of Technology. Source: South China University of Technology Food Science Program Graduation Requirements Website http://www2.scut.edu.cn/sp/ Training Credits %（out of 170） Required by the MOE Thesis 12 7.06% √ Internship 12 7.06% Activities 6 3.53% Total 30 17.65% 224 To meet the needs of different jobs for graduates, American universities have set up different concentrations and offer specialties limited courses. For example, MSU's Food Science program has four concentrations: Basic Food Science, Food Business, Food Packaging, and Food Technology. The University of Minnesota-Twin Cities divides its Food Science program into track A, which is IFT-accredited, and Track B, which has 21 free electives and can be taken with a minor. U.S. undergraduates can enroll in courses covering a wide range of fields, and students can take courses regardless of their major or department (FSCN, 2014). In terms of credit allocation, the range of options available in China is small compared to the Food Science and Technology programs in the United States. Taking the two schools mentioned above as examples, students at MSU need only 106 credits to complete the Food Science program curriculum, and to meet the 120-credit requirement for graduation, students can choose any 14- credit courses based on their needs and preferences. The SCUT, on the other hand, does not leave students with the freedom to choose their own credits. 6.4 Major Courses Comparison For the food science program specialization courses, both China MOE and IFT have detailed descriptions and requirements for the courses. In terms of 225 course descriptions, MOE's requirements are more specific compared to IFT (Table 6.10)(China Education, 2011). IFT, on the other hand, puts the course requirements in the "Essential Learning Outcomes" section (IFT, 2021a). For example, for "Food Microbiology", IFT requires students to be able to: 1. Identify relevant beneficial, pathogenic, and spoilage microorganisms in foods and the conditions under which they grow. 2. Describe the conditions under which relevant pathogens are destroyed or controlled in foods. 3. Apply laboratory techniques to identify microorganisms in foods. 4. Explain the principles involved in food preservation via fermentation processes. 5. Discuss the role and significance of adaptation and environmental factors (e.g., water activity, pH, temperature) on growth response and inactivation of microorganisms in various environments. In addition to the required courses listed in Table 6.10, IFT also has specific requirements for "Critical Thinking and Problem Solving," "Food Science Communication," and "Professionalism and Leadership. Overall, we can find that the major course requirements for the food science programs in China and the United States are generally the same. 226 Table 6.10 Requirements of MOE(China) and IFT(U.S) for major courses of the Food Science Program. MOE IFT Food Chemistry The composition of the main components of food, physical and chemical properties and their changes in processing and storage and the flavor and composition of food. The structure and properties of food components (water, carbohydrates, protein, lipids, other components and food additives); the chemistry of changes occurring during processing, storage, and utilization. Food Microbiology Morphology, structure, taxa, identification of microorganisms, laws of microbial life activities, metabolism, genetic variation, infection and immunity, and control of environmental pollution, food contamination and disease occurrence and microbial activities caused by microorganisms. Microorganisms in food include beneficial, pathogenic, and spoilage; the influence of the food system on their growth, survival, and control. Food Safety Endogenous natural harmful substances in plants and animals, spoilage of food, contamination by microbial toxins, contamination by environmentally harmful substances, contamination by harmful substances in packaging materials and containers, the safety of non- heat sterilized food, the safety of genetically modified food, HACCP, GMP, etc. Hazards (physical, chemical, biological) associated with foods and the food system; their transmission and control. 227 Food Engineering and Processing Basic principles of transfer processes and unit operations in food industry production, intrinsic laws, common equipment and calculation methods of the process. Food engineering principles; food preservation and processing; packaging materials and methods; cleaning and sanitation; water and waste management. 228 6.4.1 Food Analysis "Food Analysis" is a basic course required by both IFT and China MOE for the food science program. The goal of the course is to develop students' ability to analyze and test food products. “Food Analysis” is very important in ensuring the quality and safety of food, as well as the source of food contamination by toxic and harmful substances and control of contamination. According to the requirements of China MOE, "Food Analysis" must include the principles of chemical analysis, instrumental analysis, food enzyme analysis and microbiological testing, as well as the determination of various components in food. The requirements of IFT for "Food Analysis" are included in the "Food Chemistry" course (IFT, 2021a). In the following parts, we have chosen Jiangnan University (JNU) and UMN for a specific comparison of "Food Analysis". The course descriptions of "Food Analysis" in Jiangnan University and UMN are generally the same, and the course is considered to be a discipline that studies and evaluates the quality of food and its changes (Table 6.11)(JNU, 2021). Its main task is to examine the quality of raw materials, auxiliary materials, semi-finished products and finished products according to the technical standards established, based on some basic theories of physics, chemistry and biochemistry and the use of various scientific techniques. According to the course descriptions, the course objectives for "Food Analysis" are also generally the same at both schools. Both schools require a combination of laboratory 229 courses of a certain length to ensure that students are adequately trained and familiar with the instrumentation. The difference is that JNU requires one more prerequisite course than UMN, which is "Biochemistry". Also, compared to UMN, JNU’s laboratory courses have a small percentage of marks and there is no midterm exam. In other words, the final exam score will determine the overall grade of the "Food Analysis" course for JNU students. 230 Table 6.11 Comparison of Food Analysis Course Syllabus between JiangNan University and the University of Minnesota, Twin Cities. **One conventional credit is hereby defined as equivalent to three hours of learning effort per week, averaged over an appropriate time interval, necessary for an average student taking that course to achieve an average grade in that course. JiangNan University University of Minnesota Course description The framework of food analysis, basic analytical content, analytical methods and measurement significance. Major analytical tools needed for any investigation in food Science and technology Lab Required Required Prerequisites Biochemistry; Food Chemistry Food Chemistry and Functional Foods Credits* 4 4 Assignments and Evaluation Assignments: 10% Lab: 10% Final exam:80% Final exam:25% Midterm: 12.5% Quizzes: 17.5% Lab: 38.75% Attendance: 6.25% Objectives 1. To understand the basic principles of food analysis methods 1. To identify the principles, purposes, and applications of techniques to chemically and instrumentally analyze foods. 2. To acquire analytical methods and experimental skills including sampling, sample pre-treatment, data analysis, and presentation of results 2. To identify appropriate methods for proximate analysis as well as chemical and physical characterization of food constituents, ingredients and products. 3. To provide chemical and instrumental laboratory experience for students in the Food Science curriculum while training them to interpret and discuss scientific data. 231 JiangNan University 's "Food Analysis" course is based on the standards made by the MOE and industry, forming a knowledge structure consisting of nine parts with basic theoretical knowledge and operational skills required for the job (Table 6.12). These nine sections include sensory testing of food, physical testing, chemical testing, testing of toxic and hazardous substances, testing of food additives, testing of minerals in food, testing of food microorganisms, testing of food packaging materials and containers, etc. The arrangement varies slightly from school to school. Like JiangNan University, UMN's "Food Analysis" also begins with the selection and preparation of samples. However, JNU does not include "data processing" at the beginning of the course as UMN does but explains it at the end of all topics. The major difference between JNU and UMN is that UMN's "Food Analysis" is categorized by the test method, and the theory of different instruments is explained to illustrate the scenarios in which they can be used. From Table 6.12, we can see that JNU's "Food Analysis" is a course in which the appropriate testing methods and instruments are explained under the topic of different substances (minerals, vitamins, ash, etc.). In terms of experimental arrangement, UMN focuses on the introduction and use of specific instruments according to the course topics, while JNU focuses on specific substances. 232 Table 6. 12 Comparison of lecture topics and labs of Food Analysis between JiangNan University and University of Minnesota, Twin Cities. Lecture Topics JiangNan University University of Minnesota Purpose and tasks of food analysis (sample preparation/selection/storage) Intro to Food Analysis (sample selection and preparation; choice of methods) Water Activity/Ash Content (distillation and diffusion methods/Potassium permanganate titration method; Karl-Fischer method) Chromatography Principles and Applications in Food Analysis (GC; HPLC) Fat Identification and Characterization (Soxhlet extraction method; acid hydrolysis method; chloroform methanol method; saponification/iodine/peroxide value) Spectroscopy/Spectrometry Principles and Techniques Isolation and Quantification of Organic Acids (GC; HPLC) Proximate Composition-- Moisture; Ash; Fat; Protein; Total Carbohydrate Carbohydrate Identification and Characterization (starch/fiber/pectin enzymatic method; carbazole colorimetric method) Microelement Analysis (Vitamins; Mineral analysis) Protein Identification and Characterization (FTIR; GC; HPLC; Kjeldahl method) Enzymatic Methods (Alkaline phosphatase; peroxidase; Pectin methylesterase; Analyses) Vitamins/Mineral Analysis Chemical Characterization (Carbohydrate, fat, protein, identification and characterization; pH and titratable acidity) Food Additives (sweetener/preservatives/coloring agents) Immunoassays in Food Analysis--ELISA (antibiotics, mycotoxins, GMOs) Detection of Veterinary Drug/ Pesticides/Heavy Metal Residues Analysis of Food Contaminants, Residues and Chemical Constituents of Concern Data Processing Methods Analysis of Extraneous matter 233 Lab Experiments Sample Preparation Nutritional Labeling Using a Computer Program Water Activity Assessment of Accuracy and Precision Ash Preparation of solutions Acidity HPLC/Gas Chromatography (GC) Rotational lab Fat Atomic Absorption/Mass Spectrometry Rotational Lab Carbohydrate Determination of Moisture Content; Water Activity Rotational Lab Protein Ash and Fat and Analysis Rotational Lab Vitamins Protein Analysis Rotational Lab Heavy Metals Phenol-Sulfuric Acid Method of Total Carbohydrates Fat Characterization: Saponification value, Iodine value and Peroxide value pH and Titratable Acidity 234 6.4.2 Food Quality The course "Food Quality", as a cross-disciplinary subject, is one of the required courses in the Food Quality and Safety Program and the Food Science Program. Through this course, it is important to improve the basic theory of food practitioners and is also an important part of the application of professional knowledge to analyze and detect food quality and safety problems in the whole food production and processing industry chain, hazard control and process management. The course "Food Quality" is a good fit with the previous section and is important for food safety, so we will use JNU and UMN as examples for comparison. As we can see from Table 6.13, both JNU and UMN's "Food Quality" course descriptions include quality issues in food products from the production of raw materials to the final product. Neither university requires a lab course, but the prerequisite requirements are slightly different. JNU requires students to have taken "Food Chemistry" and "Organic Chemistry" before they can take "Food Quality". Therefore, there may be a slight difference in the theoretical foundation of students who take "Food Quality". In terms of teaching objectives, both JNU and UMN focus on the students' understanding of the complete process of food quality management. 235 Table 6.13 Comparison of Food Quality course syllabus between the JiangNan University and the University of Minnesota, Twin Cities. **One conventional credit is hereby defined as equivalent to three hours of learning effort per week, averaged over an appropriate time interval, necessary for an average student taking that course to achieve an average grade in that course. Food Quality JiangNan University University of Minnesota Course description Explains the influence of environment, production, storage, transportation equipment, and packaging materials on food safety; also introduces theories and methods related to food safety evaluation, food safety standards and quality control. This course is designed to give students an overview of the management systems, statistical procedures, and regulatory requirements involved with producing quality food and ingredients. Lab Not Required Not Required Prerequisites Food Chemistry; Organic Chemistry Junior Credits* 3 3 Objectives 1. To understand the relationship between food safety and contamination between the environment, and the main factors and preventive measures for safety during processing and storage. 1. To understand the management systems in food processing/distribution to ensure food quality/compliance with food laws/regulations 2. To have a more comprehensive understanding of the various factors affecting food quality and safety 2. To learn about quality management, HACCP, auditing, hygienic design of plants/facilities, specifications, recalls, control systems. 236 In terms of course content, JNU has divided "Food Quality" into three sections: general introduction(current status of food safety control), hazard analysis(environment pollution; chemical hazards; biological contamination), and food safety control systems(GMP; SSOP; HACCP; ISO9000) (Table 6.14). Similarly, UMN's "Food Quality" is also divided into three sections: background and guidance information; food safety plan development(laws and regulations), and preventive controls for human food regulation(GMP; HACCP). A comparison of JNU and UMN's "Food Quality" course content shows that HACCP and GMP are valued by both China and the US as risk-based preventive systems to effectively ensure food safety. Compared to JNU, UMN's "Food Quality" curriculum design is not clearly organized and may not give students a systematic impression. However, UMN intersperses the course with a lot of macro-level introduction to food quality and safety, which makes it easier for students to understand the content. 237 Table 6.14 Comparison of lecture topics of Food Quality between the JiangNan University and the University of Minnesota, Twin Cities. Lecture Topics JiangNan University University of Minnesota Current status of food safety control Preliminary Steps in Developing a Food Safety Plan The impact of environmental pollution on food safety Good Manufacturing practices and Other Prerequisite Programs for Preventive Controls Foods containing naturally occurring toxic substances Statistical Process Control and Sampling Plans Chemical hazards (heavy metals, pesticides, veterinary drugs, additives) cGMP, HACCP Biological contamination (bacteria, fungi, viruses, parasites) Supply-Chain Preventive Controls Food standards and development procedures Chemical, Physical and Economically Motivated Food Safety Hazards GMP Food Allergen Preventive Controls SSOP Sanitation Preventive Controls HACCP Labeling Law ISO9000 Quality Management System Food Defense: Protecting Food from Bioterrorism and Intentional Adulteration for Economic Gain 238 By comparing the syllabus of "Food Analysis", "Food Quality" and description of other major courses in China and the United States, we found that the courses in both countries are roughly the same in terms of curriculum design. One of the main differences is that the Chinese curriculum focuses too much on final exam scores, which leads to students neglecting laboratory classes and thus affects their practical skills. Laboratory class is an important way to consolidate theoretical knowledge and is an important impetus to develop student's analytical and problem-solving skills. In some Chinese institutions, due to financial constraints, the instruments and equipment cannot be updated, and only old and simple instruments can be used to determine some physical and chemical properties. In addition, although the number of students enrolled in Chinese universities has increased, the laboratory equipment has not increased accordingly, resulting in more people and fewer instruments in the laboratory classes and fewer opportunities for each person to operate them personally. Another difference is that the U.S. curriculum is not as logical as it could be. The design of the specialized classes is not very well defined, which may make it difficult for students to establish a smooth thought process. At present, the food science courses in China and the US are trying to move closer to industry and make every effort to solve the problems that may arise in real work, which is a good development direction. 239 6.5 Conclusion Overall, the Food Science program in China is very engineering-oriented. For example, SCUT not only has Engineering Drafting as a required course for the entire university, but also requires Electrical Engineering & Mechanical Design for the Food Science major. This is because Food Science is positioned differently in the two countries. Food Science programs in the United States are generally part of the College of Agriculture or the College of Natural Resources, while in China they are part of the College of Engineering. Technology is a complete system. Engineering problems are comprehensive and complex, and its solution may need to span many related disciplines, involving art, aesthetics, society, humanities, and even economy, law, environment, etc. Therefore, a qualified engineer must have a wide range of humanities and social science literacy. The curriculum of Food Science and Technology programs in Chinese universities is relatively weak in humanities and social sciences, and the courses and hours offered are insufficient. Food Science and Technology majors serve a complex and diverse range of objects, including all aspects of the upstream and downstream food industry chain. The knowledge and ability required by each industrial link have a big difference. It is still very uncertain which link students want to enter after graduation, which determines that the curriculum of Food Science and Technology majors should not be too narrow and should leave ample space for students to choose. 240 Food Science education in China and the U.S. should be more interactive. Nowadays, top-ranked Chinese universities in Food Science, such as Jiangnan University, have exchange programs with the United States. Jiangnan University and the University of California, Davis have a "2+2" joint training program, which means two years in China and two years in the U.S., with credits being exchanged. Through continuous communication and learning, the university can raise food scientists and food engineers who are more competitive and meet international standards. 241 Chapter 7 COVID-19 7.1 Introduction The COVID-19 pandemic, which began in late 2019, is the fastest spreading and most widely infected major public health event in the world since the 20th century (WHO, 2020). This unexpected pandemic has disrupted the routine lives of people around the world due to the enormous difficulty in preventing and controlling it. The pandemic has had a serious negative impact on the global economy. Taking into account that the food supply chain, especially cold chain transportation, is one of the most important sectors of the economy and trade, COVID-19 has been considered to affect the entire process from the field to the consumer. Given the recent challenges in the food supply chain, there is now a great deal of focus on food production, processing, distribution and demand. The COVID-19 disease, caused by the novel coronavirus SARS-nCoV-2, spread worldwide in a short period and many countries declared a health emergency (CDC, 2020b). SARS-CoV-2 is thought to be a spillover of an animal coronavirus that was later adjusted to human-to-human transmissibility. Due to the highly infectious nature of the virus, it spread rapidly and evolved in human populations. To date, we can trace the first reported and subsequent outbreaks since late December 2019 from a cluster of novel human pneumonia cases in 242 Wuhan, China. These patients were diagnosed with symptoms of viral pneumonia, including fever, malaise, dry cough, and dyspnea (Y.-C. Liu et al., 2020). On March 11, 2020, the World Health Organization declared COVID-19 disease a pandemic (WHO, 2020). This was the fifth pandemic declared by the WHO and the first pandemic caused by a coronavirus; the remaining four were caused by influenza viruses. The four pandemics that occurred before the COVID-19 one caused approximately 50 million(1918, H1N1), 1.5 million(1957, H2N2), 1 million(1968, H3N3), and 300,000(2009, H1N1) human deaths, respectively (Y.-C. Liu et al., 2020). As of May 8, 2021, there are more than 156,077,747 COVID-19 infections and more than 3,256,034 deaths worldwide, including approximately 32,608,287 infections and 580,073 deaths in the United States and approximately 90,739 infections and 4,636 deaths in China (CDC, 2021a). (The New York Times, 2021). One major difference between the COVID-19 pandemic and the previous four pandemics is the insidious nature of the virus. In terms of disease manifestations, COVID-19 virus infections are not only in mild, common, severe, and critically ill patients, but also in asymptomatic infected patients, which is highly insidious. In contrast, in previous pandemics, such as the 2009 H1N1 pandemic, infected individuals almost always exhibited high fever and could be quickly identified to contain the source of infection (Y.-C. Liu et al., 2020). 243 Another point of difference of COVID-19 pandemic is the diversity of virus transmission routes. The transmission routes of the COVID-19 virus include direct transmission, aerosol transmission and contact transmission (CDC, 2021b). Direct transmission refers to the infection caused by the patient sneezing, coughing, talking droplets, exhaled gas close to direct inhalation. Aerosol transmission refers to droplets mixed in the air, forming an aerosol, which leads to infection after inhalation. Contact transmission refers to droplets deposited on the surface of objects, contact with contaminated hands, and then contact with the oral cavity, nasal cavity, eyes and other mucous membranes, resulting in infection. H1N1 is mainly spread by close human-to-human contact. COVID-19 disease has led to the initiation of strict protective measures worldwide, including traffic control, isolation of personnel, closure of various markets, and suspension of operations. These protective measures have led to restrictions on the movement of workers, changes in consumer demand, closure of food production facilities, restrictions on food trade policies, and financial pressures on the food supply chain. At the same time, as the COVID-19 pandemic continues to develop, the potential risk of COVID-19 toxic input to imported cold-chain foods around the world continues to increase. The safety of cold-chain foods is of great concern to the community. The purpose of this chapter is to assess the impact of COVID-19 on the food supply and production chain, food safety, and food trade, and to summarize the recommendations needed to reduce and control the impact of the pandemic. 244 7.2 Food Supply Chain To date, the COVID-19 pandemic has not had a direct and significant impact on global food supplies or prices. Bulk commodities are handled and transported with less direct human contact. In addition, global reserves of nonperishable grains such as wheat and rice should be sufficient to meet any surge in demand. As a result, there have been no major disruptions in food supplies. In the case of perishable foods such as vegetables and fruits, transportation restrictions and stricter quarantines have had a greater impact on their supply, but countries have not yet experienced widespread disruptions in vegetable supplies on a national scale (Aldaco et al., 2020). Evidence from China demonstrates that food supply disruptions can be reduced through the establishment of "green lanes" that allow the movement of workers and products involved in the transportation, production and distribution of agriculture and foodstuffs to be unaffected by embargo measures (Laborde et al., 2020). Labor-intensive value chains are more affected than capital-intensive food value chains. Moreover, the impact on food distribution in low-income countries is often more severe for the tens of millions of informal small and medium-sized food sector operations (Morton, 2020). These small and medium-sized food businesses are often labor-intensive, with many people having to work in close proximity to dense areas and crowded markets, where the risk of COVID-19 transmission is extremely high, and where social distancing measures directly affect the functioning of food businesses and markets. 245 Modern food supply chains and systems have also been severely impacted. The almost complete shutdown of international passenger airlines has severely disrupted the supply chain for specialized products that rely on air transportation. In-home isolation has shifted many people's dining needs from restaurants to homes, which has contributed to a decline in the consumption of high-quality meat, dairy products, and vegetables. In the United States and Europe, large numbers of meat processing plant workers have been infected with COVID-19, causing meat processing plants to close or slow production. In April 2020, the White House passed an order to try to keep meat processing facilities open, and a report at the time found that counties with meat processing plants were the worst hotspots in the United States, with new cases occurring at twice the national average (Katherine, 2020). As of July 30, 2020, 38,403 meatpacking workers have tested positive for COVID-19, and at least 171 of those workers have died. The majority of these infected employees were from Tyson Foods. Tyson has had 10,104 cases, or a quarter of all cases in the industry (Mike, 2020). The sudden COVID-19 pandemic has created a huge impact and challenge to the global economy and food supply chain. In the long term, the global economic recession and shrinking demand for agricultural products caused by the COVID-19 pandemic will lead to a further decline in agricultural prices. However, in the short term, supply chain disruptions and the introduction of panic and phased export restrictions in some agricultural exporters could lead 246 to increased expectations of market uncertainty and high price volatility. Uncertainty and increased instability will hit the enthusiasm of market participants to be involved in international trade and the confidence of some countries to rely on international markets to secure domestic agricultural supplies, leading to a contraction of trade investment and a decline in the scale of international agricultural trade. 7.3 Food Safety Consumers have developed unprecedented concerns about the safety of food in the face of the COVID-19 global pandemic. Especially in the early 2020s, consumers overbought some necessities and foods due to panic psychosis and many stores' shelves were temporarily emptied (Nicola et al., 2020). During the COVID-19 pandemic, two major issues emerged in the food industry. First, there was concern that the food products purchased could transmit the COVID-19 virus. Second, food safety issues received increased attention to preventing the spread of the coronavirus among producers, retailers, and consumers. Due to the different confinement restrictions in the United States and China, the impact on food safety was different. With respect to the concern about transmission of COVID-19 viruses through food, the CDC considers this possibility to be low. Despite the magnitude of the pandemic, to date, there is no definitive evidence that COVID-19 can be 247 transmitted through food consumption. SARS-CoV-2, the virus that causes COVID-19, is an enveloped virus, which means that its genetic material is packaged within an envelope (composed of proteins and lipids) (CDC, 2020b). The envelope contains spike proteins, which are structures that can attach to human cells during infection. SARS-CoV-2, like other enveloped respiratory viruses, can rapidly degrade upon exposure to surfactants in detergents and environmental conditions. This makes the daily cleaning of staff involved in food production and distribution, and the disinfection of factory plants and equipment particularly important. Another factor associated with the transmission of the COVID-19 virus through food is the survival of the virus on porous and non-porous surfaces. Some studies claim that on porous surfaces, such as paper and clothing, viable viruses cannot be detected within minutes to hours (Chatterjee et al., 2021). In contrast, on nonporous surfaces, such as stainless steel, plastic, and glass, viable viruses can be detected for days to weeks. SARS-CoV-2 is significantly faster to be inactivated on porous surfaces compared to nonporous surfaces, but because these data were conducted under laboratory conditions in a room setting, the results obtained do not necessarily reflect real-world conditions. In the matter of COVID-19 transmission among workers involved in food production and transportation, China and the United States have different approaches to control. Early in the COVID-19 pandemic, when several hundred 248 new cases per day began to be reported in Wuhan, China, China began a strict quarantine of each province where COVID-19 cases were found. In Hubei province, where the COVID-19 situation was most severe, no one was allowed to leave their homes and all necessities were delivered to their homes by health care workers or volunteers wearing protective clothing. In cities where the situation is relatively less severe, meaning that there are fewer new cases, people can wear masks and go to the entrance of their neighborhoods to shop for food delivered by hand. All passengers flying into China from other countries will need to be isolated in a uniform location for 14 days and tested daily for COVID-19. This strict isolation did not end until a month or so later, when most cities were approaching single digits in new cases. In the middle of the COVID-19 pandemic, most U.S. cities also implemented home quarantine and work from home. For a long time, large shopping centers and theaters were closed. People in the U.S. were able to go to the supermarket to purchase their own necessities instead of having to have uniform food delivered by a special person. Contactless delivery, take-out, and express delivery became a major part of American life during this time. However, because the importance of masks has not been recognized by the public for a long time and for many other reasons, an average of more than 200,000 new cases was detected each day in January 2021. Because of the different control methods for COVID-19, the United States and China have different concerns about food safety. China no longer has locally 249 detected cases due to the extremely strict quarantine measures it has undergone. Therefore, China's concern is focused on the safety of imported food. The Chinese public is worried that food imported from outside of China can carry the COVID-19 virus and further infect people. The U.S. public is more concerned about the spread of infection among workers in crowded food factories, restaurants, supermarkets, and shopping malls. In terms of imported food, China has made many improvements in food safety and proposed many preventive measures due to the spread of COVID-19. The State Administration for Market Regulation (SAMR) issued a "Notice on Strengthening Quality and Safety Management of Refrigerated and Frozen Food" in China on March 16, 2020 (SAMR, 2020b). On September 11 of the same year, the National Health Commission (NHC) and SAMR issued the "National Standard for Food Safety - Sanitary Code for Food Cold Chain Logistics"(GB31605—2020; GB 31605—2020) and the General Administration of Customs (GAC) issued the "Announcement on the Implementation of Emergency Preventive Measures for Overseas Manufacturers of Imported Cold Chain Foods with Positive COVID-19 Tests. On the same day, the General Administration of Customs (GAC) issued the "Announcement on the Implementation of Emergency Preventive Measures for Overseas Manufacturers of Imported Cold Chain Food with Positive COVID- 19 Test Results" (SAMR, 2020a). Since October 2020, the COVID-19 expert group under the State Council has been issuing guidelines for the prevention and control of the virus in imported cold chain foods, technical guidelines for 250 disinfection, and preventive and comprehensive disinfection plans. On November 27, the COVID-19 expert group issued a notice to further strengthen the cold chain food traceability management system (The State Council, 2020). As a result of the COVID-19 crisis, response plans were developed for food workers in the U.S. The CDC has provided guidance for the continued operation of food processing facilities. In particular, the meat and poultry processing industries were given extra attention as critical infrastructure for food and agriculture. The CDC provided plans that included tiered control requirements for facility cleaning, sanitation, disinfection, screening and monitoring of workers for COVID-19, management of sick employees, and educational programs for workers and supervisors to prevent the spread of the COVID-19 virus (CDC, 2020a). 7.4 Trade The COVID-19 pandemic will negatively impact global Foreign Direct Investment (FDI) flows, according to the Global Investment Trends Monitor held by the United Nations Conference on Trade and Development (UNCTAD) in March 2020 (UNCTAD, 2021). The COVID-19 pandemic will result in a 5% to 15% decline of global FDI in 2021, depending on the different assumptions for the development of COVID-19. Although agricultural investment is not the most affected sector monitored, it is bound to be affected as the outbreak spreads. 251 Much of the impact will be caused by deferred investment due to lower overall demand. Economies that are more dependent on trade in Global Value Chains (GVC) will also be more affected. Even in the case of quarantine restrictions or border closures, it is critical to continue to maintain the flow of agricultural inputs and agricultural products between countries. On March 30, 2020, FAO called for "the critical importance of maintaining stable operations in the global agri-food chain." (FAO, 2021a). On March 31, 2020, FAO, WHO, and WTO jointly declared their hope to mitigate the impact of COVID-19 on food trade and markets (Gu et al., 2021). Avoiding trade- restrictive policies can be as effective as direct support activities in protecting consumers and farm incomes. Many countries are therefore calling for keeping global trade open, as well as removing trade restrictions and bans, to ensure food security during the COVID-19 pandemic. The global expansion of the pandemic has led to increased downside risks for the global economy, which will lead to a long-term contraction in demand for agricultural products. Following a phase of price rebound, exporting countries have gradually lifted export controls, including Vietnam's decision to fully resume rice exports in late April and Cambodia's decision to lift export restrictions in mid- May. Kazakhstan decided to lift all restrictions imposed on agricultural exports due to the Newcastle pneumonia outbreak from June 1 (Gu et al., 2021). While the epidemic is spreading globally, some countries have achieved initial control of the epidemic. Lockdowns and other measures imposed to 252 prevent and control the epidemic were gradually lifted and economies began to recover. The FAO Food Price Index, a measure of monthly changes in international prices of a basket of food commodities, provides a clear picture of changes in global prices of major food items during the COVID-19 pandemic. According to FAO statistics, FFPI continues to grow from June 2020, recovering to 95.8 in August and growing rapidly from 2021 (Table 7.1). 253 Table 7.1 The FAO Food Price Index, Jan 2020 to April 2021. Note. Data were adapted from the Food and Agriculture Organization of the United Nations Food Price Index Meat Dairy Cereals Vegetables Oils Sugar 2020-01 102.5 103.6 103.8 100.5 108.7 87.5 2020-02 99.4 100.5 102.9 99.4 97.6 91.4 2020-03 95.1 99.4 101.5 97.7 85.5 73.9 2020-04 92.4 96.9 95.8 99.3 81.2 63.2 2020-05 91.0 95.4 94.4 97.5 77.8 67.8 2020-06 93.1 94.8 98.3 96.7 86.6 74.9 2020-07 93.9 92.2 101.8 96.9 93.2 76.0 2020-08 95.8 92.2 102.1 99.0 98.7 81.1 2020-09 97.9 91.5 102.3 104.0 104.6 79.0 2020-10 101.2 91.8 104.5 111.6 106.4 84.7 2020-11 105.5 93.3 105.4 114.4 121.9 87.5 2020-12 108.5 94.8 109.2 115.9 131.1 87.1 2021-01 113.3 96.0 111.2 124.2 138.8 94.2 2021-02 116.4 97.8 113.1 125.7 147.4 100.2 2021-03 118.9 100.1 117.5 123.6 159.2 96.2 2021-04 120.9 101.8 118.9 125.1 162.0 100.0 254 7.5 Conclusion Various evidence indicates that food is not a source of coronavirus, and that the virus cannot be transmitted through food consumption. However, environmental surfaces, such as door handles, light switches, or food contaminated with the COVID-19 virus, are still a possible risk of being infected. Hand washing should always be a concern since SARS-CoV-2 can be effectively transmitted through the air. In addition, retailers must follow sanitation requirements while handling food. Government health departments should give guidance for controlling and preventing the spread of COVID-19. Grocery workers must wear masks and gloves and change them frequently when cutting, slicing, or packaging food. Consumers also have a responsibility to prevent the spread of the virus by wearing masks in public places and by not touching products they are not willing to buy. Each country should establish a crisis committee to focus on the impact of COVID-19 in the food value chain and not wait too long to implement certain strategies and interventions. As a key part of observing progress and recommending action, this committee should work to reduce the impact of COVID-19 on agriculture and food. Governments should also provide financial and personnel assistance to small farms, small food companies, and their staff affected by COVID-19. While global food supplies are currently generally adequate and food prices are stable, the rapid spread of COVID-19 and the uncertainty of virus 255 mutations will pose a threat to global food security. Global food supplies are impacted by isolation and border closures. Food distribution channels may be hampered by transportation disruptions and stricter quarantine measures, with increased transportation costs and reduced efficiency in trade. Food security is no longer a regional issue, but a global issue that needs to be addressed together. Countries should work together to strengthen cooperation and global governance and take quick protection and assistance measures for the most vulnerable. Countries should ensure the proper functioning of domestic food supply chains, at the same time, they should keep trade open and use innovative e-commerce to secure food supplies and guarantee global food security. 256 Chapter 8 Conclusion By analyzing a large amount of trade data from broad to small categories, we found that China's exports to the United States are mainly labor-intensive food products (e.g., fish-fillets, dried vegetables, processes fish, processed crustaceans, other processed fruits and nuts, and fruit juice); whereas U.S. food exports to China are more dependent on land resources and a high level of mechanization (e.g., pig meat, poultry meat, whey, wheat, corn, sorghum, and soybeans). The agricultural products produced and traded by the United States and China are highly complementary. The agricultural products produced in both countries have an important position in both markets and the development of agricultural trade between the two countries has been relatively stable. Even with the impact of the trade war, the forecast for future agricultural trade between the two countries is still up. An overall analysis of the food safety governance framework reveals several problems in the Chinese and U.S. systems. Over the 20th century, there have been many changes in food safety related agencies in China compared to the United States, leading to a series of issues. Merchants and consumers did not know which agency to file a claim about a problem with their food. Agency staff is confused about their responsibilities due to multiple changes in their scope of operations. At the same time, China's food safety controls are based on a "segmented management" approach, where each product has its own 257 responsibilities at different stages, rather than a "product management" approach, where each product is divided into product categories and is "managed to the end" as in the United States. This has led to many regulatory loopholes. China needs to strengthen its administrative supervision of food safety, mainly by enhancing the management level and efficiency of various departments. From the U.S. approach to food supervision, we can see that the prevention of food safety problems is the future trend in food surveillance. According to the regulations of the most traded food categories in China and the US, another important aspect that China needs to focus on is the construction of technologies, standards, etc. By comparing the standards and regulations of Chinese, American and world organizations for specific food categories, we find that although the Chinese standards and regulations are in line with the world standards, and even more stringent than the American standards, they lack operability in specific facts. Opaque information disclosure mechanisms make it difficult for the public to obtain information about food safety from public sources, further creating a sense of distrust in food safety. Thus, even with strict food safety standards and regulations, the Chinese public remains skeptical of the food they consume daily. We found that there are significant differences between the U.S. and China in terms of import/export regulations and management of specific food items. Therefore, these regulations need to be carefully reviewed for traders in both countries. At the same time, the Chinese food standards should be 258 harmonized nationwide. A sound legal system is the basis for the smooth implementation of food safety regulations. The United States has established a legal system covering all food categories and all parts of the food chain, which provides the basis for the development of regulatory policies, testing standards, and quality certification. By examining the number of public health emergencies in China and the United States, we found that there was a significant rise in confirmed cases when new reporting platforms emerged or when new disclosure mechanisms were added. For China, food safety risk analysis systems, HACCP, and transparent information disclosure mechanisms should be thoroughly and systematically introduced. In the case of China, more confirmed cases mean that more cases that would have gone undetected are coming to light. When the concept of "prevention" was introduced into U.S. food management, foodborne disease outbreaks were effectively kept at a steady level. In terms of undergraduate education in food science and technology, comparing the curriculum and graduation requirements between the two countries, it is easy to see that education in China is more geared toward training food engineers, while that in the United States is more focused on food scientists or food safety technicians. Although the number of courses required for graduation in Chinese universities is high and the emphasis is on basic education, the difficulty of the courses is low, and students can still receive credit for a final grade of 1.0 or less by taking a make-up exam. In contrast, the U.S. 259 curriculum is not only difficult, but also mandates a large number of laboratory courses, giving students more opportunities to practice. A comprehensive comparative analysis of Chinese and American universities shows that American colleges and universities focus more on students' self-development and do not have a uniform teaching template. The careful setting of majors and the detailed arrangement of courses allow students to choose the direction suitable for their development. In the case of the COVID-19 pandemic, the public is concerned about contracting the virus through the consumption of food. Also, workers and supermarket staff who need to come in contact with imported food or daily consumed food have the same fears. Although there is no evidence yet that the COVID-19 virus can be transmitted through food, the impact of a pandemic on the food supply chain cannot be ignored. Both the U.S. and China need to learn from the pandemic and make specific guidelines for disinfection of food plants, sanitization of equipment, and routine cleaning of staff. Timely isolation and protective measures are effective tools to reduce transmission. The entire project provides some directions for change in the management mechanism of food safety. The starting point of food safety regulation is to address market failures caused by food information asymmetries. Therefore, Food safety regulation should ideally aim to reduce information asymmetry. For example, information should be proactively conveyed to the information disadvantaged (consumers) through the construction of information screening 260 mechanisms. Food-related legislation, improvement of standards and regulations, clarification of the responsibilities of regulatory agencies, increased input into education, and preparedness in the face of emergencies are all efforts that need to be made in the next phase in China and the United States. 261 References Akerlof, G. A (1970). The Market for “Lemons”: Quality Uncertainty and the Market Mechanism. 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Section ID Section HS2 ID HS2 1 Animal Products 101 Animals; live 102 Meat and edible meat offal 103 Fish and crustaceans, mollusks and other aquatic invertebrates 104 Dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included 105 Animal originated products; not elsewhere specified or included 2 Vegetable Products 206 Trees and other plants, live; bulbs, roots and the like; cut flowers and ornamental foliage 207 Vegetables and certain roots and tubers; edible 208 Fruit and nuts, edible; peel of citrus fruit or melons 209 Coffee, tea, mate and spices 210 Cereals 211 Products of the milling industry; malt, starches, inulin, wheat gluten 212 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit, industrial or medicinal plants; straw and fodder 213 Lac; gums, resins and other vegetable saps and extracts 214 Vegetable plaiting materials: vegetable products not elsewhere specified or included 4 Foodstuffs 416 Meat, fish or crustaceans, mollusks or other aquatic invertebrates; preparations thereof 417 Sugars and sugar confectionery 418 Cocoa and cocoa preparations 419 Preparations of cereals, flour, starch or milk; pastrycooks' products 420 Preparations of vegetables, fruit, nuts or other parts of plants 421 Miscellaneous edible preparations 422 Beverages, spirits and vinegar 423 Food industries, residues and wastes thereof; prepared animal fodder 424 Tobacco and manufactured tobacco substitutes 279 Table 1.2 HS4 codes for selected HS2 level categories Trade flow HS2 HS4 ID HS4 China exports to the U.S. 103 10301 Live Fish 10302 Non-fillet Fresh Fish 10303 Non-fillet Frozen Fish 10304 Fish Fillets 10305 Processed Fish 10306 Crustaceans 10307 Mollusks 207 20701 Potatoes 20702 Tomatoes 20703 Onions 20704 Cabbages 20705 Lettuce 20706 Root Vegetables 20709 Other Vegetables 20710 Frozen Vegetables 20711 Preserved Vegetables 20712 Dried Vegetables 20713 Dried Legumes 20714 Cassava 416 41601 Sausages 41602 Other Prepared Meat 41603 Animal Extracts 41604 Processed Fish 41605 Processed Crustaceans 420 42001 Pickled Foods 42002 Processed Tomatoes 42003 Processed Mushrooms 42004 Other Frozen Vegetables 42005 Other Processed Vegetables 42006 Sugar Preserved Foods 42007 Jams 42008 Other Processed Fruits and Nuts 42009 Fruit Juice 280 U.S. exports to China 102 10201 Bovine Meat 10202 Frozen Bovine Meat 10203 Pig Meat 10204 Sheep and Goat Meat 10206 Edible Offal 10207 Poultry Meat 10208 Other Meat 10209 Animal Fat 10210 Preserved Meat 104 10401 Milk 10402 Concentrated Milk 10403 Fermented Milk Products 10404 Whey 10405 Butter 10406 Cheese 10407 Eggs 10408 Processed Egg Products 10409 Honey 210 21001 Wheat 21004 Oats 21005 Corn 21006 Rice 21007 Sorghum 21008 Buckwheat 212 21201 Soybeans 21202 Ground Nuts 21203 Copra 21204 Linseed 21206 Sunflower Seeds 21207 Other Oily Seeds 21208 Oil Seed Flower 21209 Sowing Seeds 21210 Hops 21211 Perfume Plants 21212 Locust beans, seaweed, sugar beet, cane, for food 21213 Cereal Straws 21214 Forage Crops