Index

Note: Page numbers in italic indicate a figure and page numbers in bold indicate a table on the corresponding page.

administrative approval 139—140 adulteration 47

African swine fever (ASF) 61, 69-73 agricultural quarantine inspection (AQI) 63 agri-food supply chain 78-86 amount of daily intake (ADI) 177 analytical lens 186-187

Animal and Plant Health Inspection

Service (APHIS) 46, 53-55, 63, 124 animal drugs 1-2, 15-16, 20, 50 Animal Health Protection Act (AHPA) 46-47, 53

animals 13-15, 25-26; critical review on FDA voluntary policy 24-25; FDA regulatory principles and approaches underpinning the phasing out of antibiotics in food-producing animals 18-22; FDA regulatory regimes in facilitating the approval of animal drugs 15; FDA response to antibiotic resistance due to overuse in food animals 16-17; judicial review of the legality of FDA’s decision to withhold the withdrawal process 22-24

antibiotics 13-15, 25-26; critical review on FDA voluntary policy 24-25; FDA regulatory principles and approaches underpinning the phasing out of antibiotics in food-producing animals 18-22; FDA regulatory regimes in facilitating the approval of animal drugs 15; FDA response to antibiotic resistance due to overuse in food animals 16-17; judicial review of the legality of FDA’s decision to withhold the withdrawal process 22-24; resistance to 13-14, 16-17, 20, 25-26 anti-terrorism contraband enforcement examination team (A-TCET) 63 appellate decision 23—24 approval, regulatory 15, 172

Argentina 8, 121, 132; regulation of gene-edited products in 128—129

ASEAN see Association of Southeast Asian

Nations (ASEAN)

assessments 27—29, 43; assessing existing pilot projects 86—93; assessing risks or benefits 40—42; development of EU food law 29—31; EFSA as risk assessor 35—37; EFSA’s role in scientific assessment 37—42; safety 139—140; scientific evidence in food law 31—34; see also risk assessment

Association of Korean Medicine

(AKOM) 219

Association of Southeast Asian Nations (ASEAN) 5, 8-9, 162-163, 181-182; overview of nanotechnologies 164-171; regulating nanomaterials in food as product category 171 - 177; regulatory responses to the use of nanoscale substances in food in 177- 181

Australia 130-131, 178-180 authenticity 79-82

baek shu oh 10, 216-218

benefits 1-6, 65-68, 77-78; assessing risks or benefits 40-42

blockchain 86-93; inherent limits of 98-99 blockchainizing 74-78, 99-102; assessing existing pilot projects 86-93; the “code as law” promise and its limits 93-99; “regulatory challenges in the global agri-food supply chain 78-86 border measures 62—65; see also cross-border e-commerce activities bovine spongiform encephalopathy (BSE)

19, 27, 80

Bureau of Veterinary Medicine (BVM)

16, 23

Canada 8, 67, 127, 132, 180

Canadian Food Inspection Agency

(CFIA) 127

capacity gap problem 95—96 case studies 53—55

cell-cultured meats 115—116 Center for Food Safety and Applied

Nutrition (CFSAN) 45

Center for Veterinary Medicine (CVM)

45, 50

China 80-81, 91-92, 111-112, 134-136, 144-145; current safety assessment and administrative approval 139-140; evolution of rules concerning “novel food” in 137-139; safety considerations in the application of patents regarding novel food material 142-144; the use of novel food material in health food 140-142

Chinese People’s Political Consultative

Conference (CPPCC) 135 classification 188, 218-223, 230; baek

shu oh disaster 216-218; innovative pharmaceutical industry and innovative nation 225 -228; legal entities as governance tools 228-230; transformation of the pharmaceutical industry 224-225 clearance procedures 64-65 cloned animals 155-158 clustered regularly interspaced short

palindromic repeat (CRISPR)-associated nuclease Cas9 (CRISPR-Cas9)

121- 122, 126-127, 132

“code as law” 93-99

Codex Alimentarius Commission (CAC)

3-4, 176 commercialization 55 Comprehensive and Progressive Agreement

for Trans-Pacific Partnership (CPTPP) 7 Congressional Research Service (CRS) 106-107

Consumer Affairs Agency (CAA) 189, 191, 192, 196

consumer perspectives 197-200 contested discourses 185-186, 200-201;

analytical lens to map out contours of interpretations 186-187; consumer

perspectives 197—200; controversies over FoSHU products 190-194; health food regulation in Japan 187-190; new food labeling policies adopted in 2015 194-197 controversies 1-2, 156-157, 185-186,

190-194, 202-204

corn 113, 125-126; hypothetical case study 53-55

cost-benefit analysis (CBA) 6, 13, 15, 18, 20-22, 26, 227

cross-border e-commerce activities 59-61; border measures and importation regulations 62-65; development and impact of 65-68; risks associated with 69-73

Customs and Border Protection (CBP) 62-64

customs examination station (CES) 63 cybersecurity 98

dangers 69

data protection 98

de-regulation 134-136, 144-145; current safety assessment and administrative approval 139-140; evolution of rules concerning “novel food” in 137-139; safety considerations in the application of patents regarding novel food material 142-144; the use of novel food material in health food 140-142

developers 53-55, 124, 125, 127-130 disability-adjusted life years (DALYs) 42 discourses, contested 185-186, 200-201;

analytical lens to map out contours of interpretations 186-187; consumer perspectives 197-200; controversies over FoSHU products 190-194; health food regulation in Japan 187-190; new food labeling policies adopted in 2015 194-197

distributed ledger technologies (DLTs) 7, 75, 87, 89, 96, 98-99

district court 22-23

drugs 15, 202-204, 218-223, 229-230; baek shu oh disaster 216-218; birth of a hybrid 207-210; ineffective drug or effective food? 210-215; innovative pharmaceutical industry and innovative nation 225-228; legal entities as governance tools 228-230; social life of the hybrid 204-207; transformation of the pharmaceutical industry 224-225

Drug Supply Chain Security Act (DSCSA) 100 e-commerce activities 59—61; border measures and importation regulations 62—65; development and impact of 65—68; risks associated with 69—73 economically motivated adulteration (EMA) 79-81

Egg Products Inspection Act (EPIA) 46-47, 51

enforcement of SPS measures 59-61; border measures and importation regulations 62-65; impact of SMEs and e-commerce on 65-68; risks associated with SMEs and e-commerce 69-73 environmental assessment (EA) 54 “environmental impact statement” (EIS) 51-55

Environmental Protection Agency (EPA) 6, 19, 44-47, 50-55, 125

environmental risks 18, 33, 46, 51-53, 129, 171

European food assessments 27-29, 43; development of food law 29-31; EFSA as risk assessor 35-37; EFSA’s role in scientific assessment 37-42; scientific evidence in food law 31-34

European Food Safety Authority (EFSA) 1-2, 27-34, 43, 122-123, 149, 174-176; as risk assessor 35-37; role in scientific assessment 37-42

European Union (EU) 1-3, 5-8; and blockchains 81-85; development of food law 29-31; and nanoscale substances 163, 174-176, 180-181; and novel food 134-135, 146-161; regulation of gene-edited products in 122-123; regulation of nanomaterials 174-176; and risk governance 13-14, 18, 27-28, 32-39, 41

evidence, scientific 27-29, 43; development of EU food law 29-31; EFSA as risk assessor 35-37; EFSA’s role in scientific assessment 37-42; scientific evidence in food law 31-34

existing pilot projects 86-93 experimental use permit (EUP) 52, 55 expertise, technical 95-96

Federal Food, Drug, and Cosmetic Act (FD&C Act) 46-50, 55

Federal Food, Drug and Cosmetic Act (FFDCA) 171-172

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 46, 51-52, 55

Federal Meat Inspection Act (FMIA) 47, 51, 105-106 field trials 54-55

food additives: requirements 48-49; risk assessment 176-177

Food and Agriculture Organization (FAO) 4, 18, 89, 176-178

Food and Drug Administration (FDA): approval of animal drugs 15; critical review on voluntary policy 24-25; decision to withhold the withdrawal process 22-24; phasing out of antibiotics in food-producing animals 18-22; regulating food safety risks 47-50; response to antibiotic resistance 16-17 food animals 13-15, 25-26; critical review on FDA voluntary policy 24-25; FDA regulatory principles and approaches underpinning the phasing out of antibiotics in food-producing animals 18-22; FDA regulatory regimes in facilitating the approval of animal drugs 15; FDA response to antibiotic resistance due to overuse in food animals 16- 17; judicial review of the legality of FDA’s decision to withhold the withdrawal process 22-24

food assessments 27-29, 43; development of EU food law 29-31; EFSA as risk assessor 35-37; EFSA’s role in scientific assessment 37-42; scientific evidence in food law 31-34

Food, Drug, and Cosmetic Act (FDCA) 14-17, 19-26, 47, 55

Food Industry Research and Development Institute (FIRDI) 8, 132

food law: blockchainizing 74, 78, 82-83, 86, 89, 93-102; development of EU food law 29-31; relevance to nanotechnology 178-179; scientific evidence in 31-34

food safety 76-83, 86, 89, 91-95, 98-102 Food Safety Inspection Service (FSIS) 45, 51, 63, 105-106

Food Safety Modernization Act of 2011 (FSMA) 21, 75n8, 81

food safety risks 47-51 food security 89, 109; and sustainability 84-86; WFP initiative 92-93

“Foods for Specified Health Uses” (FoSHU) 186-188, 190-196, 194

Food Standards Australia New Zealand (FSANZ) 130-131, 179

food supply chain management 89-93

“Foods with Functional Claims” (FFC) 186-188, 196

“Foods with Health Claims” (FHC) 188, 196, 228-229

“Foods with Nutrient Function Claims” (FNFC) 188-189, 195-196

gene-edited products 121-122, 122, 132-133, 133; Argentina 128-129; Australia and New Zealand 130-131; Canada 127; European Union 122-123; Japan 129-130; Taiwan 132; United States 123-127

General Agreement on Tariffs and Trade (GATT) 146-147

General Food Law (GFL) 28, 31-40, 43, 83, 178

generally recognized as safe (GRAS) 48-49, 172-173

gene technology 44-47, 45, 46-47; hypothetical case study 53-55; regulating the environmental risks 51-53; regulating food safety risks 47-51; see also gene-edited products

genetically altered animals 49-50 genetically modified (GM) 2-3, 121-124, 128-138, 147, 185

genetically modified organisms (GMOs)

122- 123, 128-133, 138

global agri-food supply chain 78-86 global value chains (GVCs) 60 glucosamine products 202-204; the birth of a hybrid 207-210; the social life of a hybrid 204-207; the social life of Viartril-S 210-215

governance 74-81, 83, 86-93, 218-223, 228; baek shu oh disaster 216-218; innovative pharmaceutical industry and innovative nation 225-228; legal entities as governance tools 228-230; transformation of the pharmaceutical industry 224-225

governing glucosamine products 202-204; the birth of a hybrid 207-210; the social life of a hybrid 204-207; the social life of Viartril-S 210-215

Hazard Analysis and Critical Control Points (HACCP) 19

health foods 140-142, 185-186, 200-201, 202-204; analytical lens to map out contours of interpretations 186-187; the birth of a hybrid 207-210; consumer perspectives 197-200; controversies

over FoSHU products 190- 194; new food labeling policies adopted in 2015 194-197; regulation in Japan 187-190; the social life of a hybrid 204-207; the social life of Viartril-S 210-215 history: meat in the United States 107-110; NFR 147-150 homology-directed repair (HDR) 122 hybrid 204-210, 212, 214 hydrochloride (HCL) 208-210, 212, 214

IBM Food Trust platform 91-92 ignored risks and dangers 69 implementation burdens 96-97 importation regulations 62-65 “inclusive” criteria 179

innovation 225-228 insects 158-160

International Agency for Research on Cancer (IARC) 191

International Centre for Trade and Sustainable Development (ICTSD) 84, 89

international trade 7-8, 59-61, 154-155, 160-161; SME involvement in 65-67

Internet of Things (IoT) 96 interpretation 23-24, 186

Japan 185-186, 200-201; analytical lens to map out contours of interpretations 186-187; consumer perspectives 197-200; controversies over FoSHU products 190-194; health food regulation in 187-190; new food labeling policies adopted in 2015 194-197; regulation of gene-edited products in 129-130

Japan Medical Association (JMA) 190 Joint FAO/WHO Expert Committee on

Food Additives (JECFA) 176-177 judicial review 22-24

knowledge, operational 95-96

Korea Consumer Agency (KCA) 217 Korea Food and Drug Administration (KFDA) 216, 227, 228

Korean (Oriental) medicine (KM) 216, 218-230

Korean Standard Industrial Classification (KSIC) 226

labels and labeling 116-117, 194-197 legal definitions 103-107, 117-118; brief history of meat in the United States

107—110; how labels shape “meat”

116-117; non-livestock “meat” 110-116 legal entities 228-230 legality 22-24; legal status of scientific

opinions 38-39

mapping 186-187 marketing glucosamine products 202-204;

the birth of a hybrid 207-210; the social life of a hybrid 204-207; the social life of Viartril-S 210-215

maximum residue limits (MRLs) 179 meat 103-107, 117-118; brief history of

(United States) 107-110; how labels shape “meat” 116-117; meat analogues 110-114; non-livestock “meat” 110-116 mechanism of action (MOA) 127 medical systems 218-223 meganuclease (MN) 121 Member States 29-31, 34-37, 149,

153-155, 174-181

Ministry of Agriculture, Forestry and

Fisheries (MAFF) 129

Ministry of Food and Drug Safety

(MFDS) 217

Ministry of Health, Labour and Welfare

(MHLW) 130

Ministry of the Environment (MOE) 129-130

moral considerations 155-158 multinational enterprises (MNEs)

59-60, 65

nanomaterials: as “inclusive” criteria

of existing product categories 179; regulating 171-177; safety of 164-171 nanoscale substances in food 162-163,

181-182; overview of nanotechnologies

164-171; regulating nanomaterials in food as product category 171-177; regulatory responses to the use of nanoscale substances in food in ASEAN 177-181 nanotechnologies 164-171, 166; relevance

of current food law to 178-179 National Academy of Sciences (NAS) 16 National Advisory Commission

on Agricultural Biotechnology

(CONABIA) 128

National Advisory Food and Drug

Committee (NAFDC) 16

National Consumer Affairs Center

(NCAC) 189

National Environmental Policy Act

(NEPA) 46-47, 51-53

National Gene Technology Scheme (NGTS) 130

National Health Insurance (NHI) 210-211, 213-215

National Health Insurance Administration (NHIA) 211, 214-215

National Research Council (NRC) 33

National Resources Defense Council

(NRDC) 14

Natural Resources Defense Association (NRDA) 22

need to protect 71-73

New Animal Drug Applications (NADAs) 16, 19, 22, 25-26

new plant breeding techniques (NPBTs) 125 New Zealand 130-131, 178-180s non-homologous end joining (NHEJ) 121,

123- 124

non-intrusive x-ray inspection (NII) 62 non-livestock “meat” 110-116 notices of an opportunity for hearing (NOOHs) 16-17, 22-24

novel food 134-136, 136, 136, 144-145, 146-147, 160-161, 180-181; current safety assessment and administrative approval 139-140; evolution of rules concerning 137-139; history of the NFR 147-150; persistent arguments and conflicts 151-160; Regulation No. 2015/2283 150-151; safety considerations in the application of patents regarding novel food material 142-144; the use of novel food material in health food 140-142

novel food regulation (NFR) 8, 127, 134-135, 138-139, 146-150, 152-154, 156

Occupational Safety and Health Administration (OSHA) 19

Office of Budget and Management

(OBM) 20

Office of Information and Regulatory Affairs (OIRA) 20-21

Office of Pesticide Programs (OPP) 45 Office of the Gene Technology Regulator (OGTR) 131

oligonucleotide-directed mutagenesis (ODM) 121-122, 128-131

operational knowledge 95-96 Organisation for Animal Health (OIE) 70 Organisation for Economic Cooperation and Development (OECD) 60, 65, 67, 175 outbreak prevention 69—71 oversight 54; see also specific agencies overuse of antibiotics 16—17

parcel shipments 64—65 patents 142-144

Peoples’ Republic of China (PRC) 70-71 permissibility 22-23, 169, 173, 179 pesticidal properties 44, 53-55 pharmaceutical industry 224-228 phasing out of antibiotics 18-22 pilot projects 86-93

Plant Pest Risk Assessment (PPRA) 55 Plant Protection Act (PPA) 47, 53-54,

124- 125

plant protection and quarantine (PPQ) 63 policies: critical review on FDA voluntary

policy 24-25; food labeling 194-197 politics, regulatory 210-215 postal shipments 64-65

Poultry Products Inspection Act (PPIA)

46- 47, 51, 105-106 precautions 14-15, 18-20, 25 Prepared Foodstuffs Products Working

Group (PFPWG) 177 product categories 171 - 177, 179 protect, need to 71-73 Provenance 89-91 public engagement 55

regional trade agreements (RTAs) 66-67, 72 regulation 44-47, 78-86, 121-122,

132- 133; animal drugs 15; antibiotics 18-22; Argentina 128-129; Australia and New Zealand 130-131; Canada 127; European Union 122-123; of health food in Japan 187-190; hypothetical case study 53-55; importation 62-65; Japan 129-130; nanoscale substances in food 162-182; of novel food 134-135, 146- 161; regulating the environmental risks 51 -53; regulating food safety risks

47- 51; regulatory politics 210-215; Taiwan 132; United States 123-127

Regulation Reform Council (RRC) 196 regulatory impact assessment (RIA) 20 research and development (R&D) 7-8,

53-54, 101, 222-229 ribonucleoprotein (RNP) 129-130 risk: associated with the development of

SME operations via e-commerce 69-73; environmental 51-53; risk analysis 32; risk management 33-38; risk assessor 35-37; see also risk assessment risk assessment 33; assessing risks or benefits 40-42; on food additives 176-177; functional separation of risk management and 37-38; versus scientific assessment 39-40

safety: of nanomaterials in food 164-171; safety assessment 139-140; safety considerations 142-144

sanitary and phytosanitary (SPS) 59-61; border measures and importation regulations 62-65; impact of SMEs and e-commerce on 65-68; risks associated with SMEs and e-commerce 69-73 science, technology, and society (STS) 204 scientific assessment: EFSA’s role in 37-42;

versus risk assessment 39-40

scientific evidence 27-29, 43; development of EU food law 29-31; EFSA as risk assessor 35-37; EFSA’s role in scientific assessment 37-42; scientific evidence in food law 31 -34

scientific knowledge, production of 207-210

scientific opinions, legal status of 38-39 seafood 89-91

SECURE rule (the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient rule) 125

shipments 64-65

Singapore Food Agency (SFA) 180-181 site-directed nucleases (SDNs) 121-123, 128-133

small and medium-sized enterprises (SMEs) 59-61, 65-73

small or medium enterprises (SMEs) 84 social life 204-207, 210-215

South Korea 218-223, 230; baek shu oh disaster 216-218; innovative pharmaceutical industry and innovative nation 225-228; legal entities as governance tools 228-230; transformation of the pharmaceutical industry 224-225

SPS measures 59-61; border measures and importation regulations 62-65; development and impact of 65-68; risks associated with 69-73

standardization costs 96-97

Subsidies and Countervailing Measures (SCM) 66

supply chains 78-86

sustainability 84-86; sustainability governance 74-81, 83, 86-93

Taiwan 202—204; and African swine fever 69—71; the birth of a hybrid 207—210; regulation of gene-edited products in 132; the social life of a hybrid 204—207; the social life of Viartril-S 210—215

Taiwan Food and Drug Administration

(TFDA) 203-204, 206, 212 technical expertise 95-96 “technical fix” 86-93, 95, 101-102 technology of governance 218-223,

230; baek shu oh disaster 216-218; innovative pharmaceutical industry and innovative nation 225 -228; legal entities as governance tools 228-230; transformation of the pharmaceutical industry 224-225

Toxic Substances Control Act (TSCA) 52 traceability 75-79, 82-84, 86-94, 96-98, 100-101

trade: SME involvement in 65-67; trade facilitation 71 -73

Trade Facilitation Agreement (TFA) 66,

69, 73

traditional foods 153-155

transcription activator-like effector nuclease (TALEN) 121-122, 126

transnational corporations (TNCs) 59-60 transparency 82-84

Treaty on European Union (TEU) 18, 34 Treaty on the Functioning of the European Union (TFEU) 34

UN High Commissioner for Refugees (UNHCR) 93

United Nations Department of

Agriculture/Animal and Plant Health

Inspection Service (USDA/APHIS) 45, 124-125, 127

United Nations Environmental Program (UNEP) 90

United States (U.S.) 44-47; history of meat in 107-110; hypothetical case study 53-55; phasing out certain antibiotics in food animals 13-26; regulating the environmental risks 51-53; regulating food safety risks 47-51; regulating gene- edited products in 123-127; regulating nanomaterials 171-173

Universal Postal Union (UPU) 64

U.S.

vegetarian meats 110-114 vehicle and cargo inspection system

(VACIS) 62-63

Viartril-S 206-208, 210-215

voluntary policy 24-25

Western medicine (WM) 204, 216, 218-219

withdrawal process 22-24

World Food Program (WFP) 76; food security initiative 92-93

World Health Organization (WHO) 4, 13, 79; risk assessment on food additives 176-177

World Trade Organization (WTO) 2-4, 32, 65-68, 75, 146, 157-160

zinc finger nuclease (ZFN) 121-122, 124, 128, 130-131

19 The IOM stated that it was “unable to find data directly implicating the subtherapeutic use of feed antimicrobials in human illness and that much of the available evidence was primarily circumstantial,

26 The recent report indicated that “domestic sales and distribution of medically important antimi­crobials for use in food-producing animals increased nine% between 2017 and 2018.

58 See generally M. Gibson, “Food Security—A Commentary: What Is It and Why Is It So Com­plicated?” (2012) 1 Foods 18; F. Snyder, “Toward an International Law for Adequate Food” in A. Mahiou & F. Snyder (eds), Food Security and Food Safety (Leiden, Brill Publishers 2006); K. Mechlem, “Food Security and the Right to Food in the Discourse of the United Nations” (2004) 10 European Law Journal 631; B. Guha-Khasnobis et al. (eds), Food Security: Indicators, Measurement

136 See generally T. Makong & T. Ngwira, “Trade Related Capacity Building Measures in African LDCs and the Paradox of the Efficiency-Effectiveness Dichotomy” in J. Pauwelyn & M. Yang (eds),

14 GG.M. Lee, “A Study on the General Public Understanding and Utilization of Korean Traditional Medicine in Colonial Period” (2006) 15(2) Korean Journal of Medical History 222, 222—231; Y J.