A

Age factors. 9

allergenicity and hypersensitivity, 68

animal wellbeing, 65, 101-102, 103

food safety, 9, 65, 70

Agricultural Research Service, 26

AI, see Artificial insemination

AIDS, see Human immunodeficiency virus

Allergenicity and hypersensitivity, 7-8, 61-62, 66, 67, 68-69

Animal and Plant Health Inspection Service, 21

Animal health and welfare, 3, 4, 11-12, 13-14, 22-23, 42, 43-44, 62, 64-65, 93-107, 119-120

see also Ethical issues

age factors, 65, 101-102, 103

Army Corps of Engineers, 113

Artificial insemination (AI), 4, 9, 12. 19, 23-24, 65, 77, 93-96

Atlantic salmon, 21, 30, 39, 90-91, 113

Avian species

committee study at hand, methodology, 2, 3, 4, 32

farm animals, 93-94, 104

gene expression, 96-97, 98-99

genetic diversity, reduction of, 48-49

infectious disease, general, 22-23, 49, 107

insect-borne diseases, 88

international perspectives, 95, 105, 107

pigs, 97, 99, 100, 102, 103-104, 105

regulatory issues, 103-104, 112

viral vectors, 46, 47

Animal Improvement Programs Laboratory, 26

Animal Welfare Regulations Act, 112

Antibiotics, 17, 19, 23, 78

knockout/knockin techniques, 38

resistance to, 23, 44-45, 47, 52, 89

Aquatic organisms, 4, 11, 21

see also Fish;

Shellfish;

specific species of fish

see also Poultry and eggs

germline modifications, 35, 46, 47

viral vectors, 46, 47

B

Bacteria, 36-37, 78

feces, 7, 62, 65

feral species, 87

food safety, 62

inserts, 45

marker genes, 44-45

pathogens, 7, 19, 23, 37, 44-45, 56, 62, 65

xenotransplantation, 56

Beef and dairy cattle, 7, 8-9, 12, 16-17, 19, 20, 24, 39, 63-64, 70-71, 83

animal health and welfare, 94, 95

bovine somatotropin (BST), 28, 109

bovine spongiform encephalopathy

(BSE), 37, 63

bovine spongiform encephalopathy, 37

embryo splitting (EMS), 63-64

genetic diversity, 49

immunodeficiency virus, 53

knockout techniques, 37

milk and milk products, 5, 7, 8, 12, 16-20 (passim), 24-28 (passim), 34, 51, 64, 65, 66, 67, 68, 70, 71, 81, 85, 102, 109, 113

nuclear transfer, 40, 63-64

regulatory issues, 62

steroids, 27

Bioactivity, 7, 66, 69-71

Biomedical applications, see Medical Applications

Birds, see Avian species;

Poultry and eggs

Blastodermal cells, 35

Blastomere nuclear transfer (BNT), 8, 18, 25-27, 31, 63-64

Boiler chickens, see Poultry and eggs

Bovine somatotropin (BST), 28, 109

Bovine spongiform encephalopathy (BSE), 37, 63

Breeding, conventional, 3, 23-24, 26, 80, 104

animal health and welfare, 93-95

artificial insemination (AI), 4, 9, 12. 19, 23-24, 65, 77, 93-95

food safety, 65

genetic diversity, 48-49

germline modification and, 42

historical perspectives, 4, 20-21

marker-assisted selection and, 28-29

C

Cancer, 43-44

leukemia, 46, 47, 52-53

Cats, 10, 46, 53, 83, 87

Cell cultures, 35

animal health and welfare, 94-96

knockout/knockin techniques, 38

marker genes, 45

nuclear transfer, 40

pharmaceuticals, 52

transposons, 37

xenotransplantation, 55-56

Cellular biology, general, 6, 31, 35, 69

see also DNA;

RNA

Center for Food Safety and Applied Nutrition, 113-114

Center for Veterinary Medicine, 114, 114

Chickens, see Poultry and eggs

Chromosomes, 35, 48, 95

see also DNA

Cloning, 12, 15, 25-27, 31

animal health and welfare, 100-102, 104-105, 107

blastomere nuclear transfer (BNT), 8, 18, 25-27, 31, 63-64

committee study at hand, methodology, 2, 4, 8-9

defined, 18

embryo splitting (EMS), 8, 26, 63-64

food safety, 61, 63-65

genetic diversity reduced through, 48-49

somatic cell nuclear transfer, 5, 18, 39-40, 47-49, 61, 64, 100-102

Coho salmon, 16, 91

Conventional breeding, see Breeding, conventional

Cost factors, 5, 31, 35

animal health and welfare, 106-107

Cultural issues, see Political issues;

Social issues

Cut-throat trout, 82

D

Dairy cattle, see Beef and dairy cattle

Definitional issues, 18

cloning, 18

environmental concerns, 73-75, 85-86

harm, 2, 8, 33, 74-75

hazard, 32, 33

risk analysis and assessment, 2-3, 15, 33, 73-75

Department of Agriculture, 26, 63, 113

Animal and Plant Health Inspection Service, 21

Department of Health and Human Services, see Food and Drug Administration

Department of the Interior, see Fish and Wildlife Service

DNA, 42, 48, 96, 99

see also Chromosomes;

Inserts

concerns about manipulation of, 42-43

knockout techniques, 38

methylation, 41, 42, 43-44, 48, 96, 101

microinjection, 35, 38, 96-97, 99

pharmaceuticals, 52

proviruses, 41-42, 43, 52-53, 59-60

scientific uncertainty, 110

sequencing, 3, 4, 6, 18, 36, 38, 45

enhanced existing traits, 79-80

feral species, effects on, 4, 10, 11, 33, 81-92, 113-115

fitness, 77-78, 80-81

insects, 1, 4, 80, 81, 83, 87-89

transfection, 5, 35-36, 38, 39

transposons, 5, 36-37, 46-47

xenotransplantation, 59-60

Dogs, 20, 83, 87

Dose-response assessment, 75

Drosophila, 34, 36-37

Drugs, see Pharmaceuticals

E

Ecologic hazards, see Environmental concerns

Economic factors, 20, 33, 69, 104, 116, 117

animal health and welfare, 106-107

avian leukemia, 47

cost factors, 5, 31, 35, 106-107

Eggs, see Poultry and eggs

Electroporation, 35

Embryos and embryonic tissue, 5, 8, 24-26, 34, 41

animal health and welfare, 93-94, 96, 97

blastomere nuclear transfer, 8, 18, 25-27, 31, 63-64

embryo splitting (EMS), 8, 26, 63-64

food safety, 8, 24-26, 63-65

knockout techniques, 38

nuclear transfer, 35, 39, 48, 63

stem cells, 5, 34-36, 38, 39-40

Endangered Species Act, 113

Environmental concerns, 3, 5, 9-11, 19, 21, 47, 62-63, 73-92, 113, 117

adaptability, 78

aquatic organisms, 4, 11, 21;

see also Fish

committee study at hand, methodology, 1, 3, 4, 9-11, 32, 73-74

definitional issues, 73-75, 85-86

international perspectives, 87

regulatory issues, 87-92, 113, 114-115

Environmental Protection Agency, 113

Enzymes, 37, 69, 103

Ethical issues, 116, 118, 119-121

animal health and welfare, 3, 4, 11-12, 13-14, 22-23, 93, 104, 116, 118

committee study at hand, methodology, 2, 3, 4, 32

conventional breeding vs biotechnology, 3, 104

religious concerns, 23-24, 116, 118

European Union, steroids, 27

Exogenous pig viruses, 55-58

Exposure, 33, 75, 76-77

human health, 6-7, 61

F

Farm animals, general, 4, 11, 12, 16, 17, 19, 23, 25, 30, 79

see also specific species

animal health and welfare, 93-94, 104

historical perspectives, 20, 21, 22, 23-24

small-scale farms, 13

FDA, see Food and Drug Administration

Feces, 7, 62, 65

Federal government, 4, 112-115

see also Food and Drug Administration;

Legislation;

Regulatory issues

Army Corps of Engineers, 113

Center for Food Safety and Applied Nutrition, 113-114

Center for Veterinary Medicine, 114, 114

Department of Agriculture, 21, 26, 63, 113

Environmental Protection Agency, 113

Fish and Wildlife Service, 113

Federal Food, Drug, and Cosmetic Act, 114

Feral species, effects on, 4, 10, 11, 33, 81-92, 113-115

see also Aquatic organisms;

Environmental concerns

fish, 83, 84, 89-92, 109

Fertility and fertilization, 5, 9, 24-25

animal health and welfare, 99

artificial insemination (AI), 4, 9, 12. 19, 23-24, 65, 77, 93-96

germline modification, 34

sterility, 29-30, 88

Fish, 7, 11, 16, 19, 21, 29-31, 39, 70-71

allergenicity and hypersensitivity, 68

animal health and welfare, 98-99

feral species, 83, 84, 89-92, 109

monosex fish, 30-31

shellfish, 7, 11, 16, 21, 29-31, 39, 68, 70-71, 92

transfection, 36

transposons, 37

Fish and Wildlife Service, 113

Food allergies, see Allergenicity and hypersensitivity

Food and Drug Administration (FDA), 1-3 (passim), 23, 31, 63, 64, 111, 113-114

bovine somatotropin, 28

conventional breeding vs biotechnology, 3

food safety, historical perspectives, 62, 70-71

xenotransplantation, 59

Food and food safety, 6-9, 16-17, 18-19, 61-72, 111, 117

see also Beef and dairy cattle;

Fish;

Milk and milk products;

Poultry and eggs

age factors, 9, 65, 70

allergenicity and hypersensitivity, 7-8, 61-62, 66, 67, 68-69

committee charge and methodology, 1, 2, 6-9, 13, 61, 73

embryos, 8, 24-26, 63-65

ethical issues, 61, 63-65

gene expression, 64-65, 66, 67, 69

historical perspectives, 3, 5, 62, 70-71

international perspectives, 62, 69

labeling, 118

regulatory issues, 62, 65-66, 70-71, 111, 113-114, 118

Foreign countries, see International perspectives

G

Gene expression, 8-9, 18, 41-42, 43, 78-79, 80, 91

animal health and welfare, 96-97, 98-99

food safety, 64-65, 66, 67, 69

pharmaceuticals, 52, 67, 69

randomly inserted genes, 41-42

somatic cell nuclear transfer (SNT), 5, 18, 48

viral vectors, 41-42, 47, 60

Germline modifications, 2, 5, 34-50

avian, 35, 46, 47

insects, 36-37

mammals, 34-35

transposons, 5, 36-37, 46-47

Goats, 10, 12, 39, 53, 83, 87, 102

Growth hormone (GH), 28, 70-71, 90-92, 99-100

H

Harm, general, 10, 30, 32

see also Risk analysis and assessment, general

defined, 2, 8, 33, 74-75

Hazard, 3-4, 11, 14, 15, 21

see also Risk analysis and assessment, general

defined, 32, 33

Historical perspectives, 1, 3-4, 5-6, 18-20, 23, 31, 34, 116-117

bovine somatotropin, 28

breeding, conventional, 4, 20-21

farm animals, 20, 21, 22, 23-24

food safety, 3, 5, 62, 70-71

hormones, 27

reproductive system, 25-26

risk analysis, 74-75

xenotransplantation, 56

HIV, see Human immunodeficiency virus

toxicity, 7, 61, 65, 66, 71-72

Hormones, 27, 79

bovine somatotropin (BST), 28, 109

growth hormone (GH), 28, 70-71, 90-92, 99-100

IGF-1, 28, 71, 109

monosex fish, 30-31

pharmaceutical production, 51, 53

Horses, 83

Human health concerns, 42, 44, 49, 88, 103, 113, 116-117

see also Food and Drug Administration;

Food and food safety;

Medical science;

Pharmaceuticals

Human immunodeficiency virus, 41-42, 46, 59

Hypersensitivity, see Allergenicity and hypersensitivity

I

IGF-1, 28, 71, 109

Immune system, 78

see also Infectious disease

allergenicity and hypersensitivity, 7-8, 61-62, 66, 67, 68-69

animal immunodeficiency viruses, 53

human immunodeficiency virus, 41-42, 46, 59

xenotransplantation, 37, 44, 55, 103

Infectious diseases, 6

see also Viruses

animal health, 22-23, 49, 107

bacterial, 7, 19, 23, 37, 44-45, 56, 62, 65

genetic diversity and, 49, 107

vaccines, 51-52, 56, 65

xenotransplantation, 55, 56-60

Insects, 1, 4, 10, 21, 80, 81, 83, 87-89

Drosophila, 34, 36-37

mosquitoes, 39, 88, 89

parasites, 88, 89

transposons, 5, 36-37

Inserts, 4, 11, 12, 16, 35, 41-42, 99-100, 115

animal health and welfare, 99

undesired, 45

Institutional factors, 13-14, 112-115

see also Federal government;

Regulatory issues;

specific federal agencies

International perspectives

animal health and welfare, 95, 105, 107

environmental concerns, 87

food safety, 62, 69

steroids, European Union, 27

xenotransplantation, 56, 103

In vitro culture, 12, 19, 25, 40

K

Knockout/knockin technologies, 1, 12, 37-38, 45

L

Labeling, 118

Legislation, 4, 113-115

Animal Welfare Regulations Act, 112

antibiotics, 17, 19, 23, 44-45, 47, 52, 78, 89

environmental concerns, 81-86

food safety and, 62-63

Methylation, 41, 42, 43-44, 48, 96, 101

Mice and rats, 5, 10, 12, 17, 33, 39

animal health and welfare, 97, 99

endogenous proviruses, 41-42, 43

endogenous retroviruses, 46

feral species, 83, 84, 87

knockout techniques, 37, 38, 45

novel genes, general, 34

pharmaceuticals, 52-53

xenotransplantation, 59

Microinjection, 35, 38, 96-97, 99

knockout/knockin technologies, 1, 12, 37-38, 45

pharmaceuticals, 52

Endangered Species Act, 113

Federal Food, Drug, and Cosmetic Act, 114

National Environmental Policy Act, 113

see also Regulatory issues

Leukemia, 46, 47, 52-53

Livestock, see specific varieties of livestock

M

Marker-assisted selection, 28-29, 35-36, 44-45

Meat and bone meal, 63, 65

Meat and meat products, general, 64, 67

see Beef and dairy cattle;

Poultry and eggs

Medical applications, 1, 4, 7, 17, 19, 33, 51-60

see also Food safety;

Pharmaceuticals;

Xenotransplantation

animal health and welfare, 102-104

Milk and milk products, 5, 7, 8, 12, 16-20 (passim), 24-28 (passim), 34, 51, 64, 65, 66, 67, 68, 70, 71, 81, 85, 102, 109, 113

see also Beef and dairy cattle

Monosex fish, 30-31

Mosquitoes, 39, 88, 89, 116-117

Mutations, 10, 20, 38, 80

animal health and welfare, 97-98

concerns about, 43-44

knockout techniques, 38

sheep, 17

N

National Environmental Policy Act, 113

National Marine Fisheries Service, 113

Novel environmental hazards, see Environmental concerns

Novel genes, 7, 16, 34-37, 66-67, 85

blastomere nuclear transfer (BNT), 8, 18, 25-27, 31, 63-64

somatic cell nuclear transfer, 5, 18, 39-40, 47-49, 61, 64, 100-102

O

Oocytes, 5, 24-25, 31, 35, 64

knockout/knockin techniques, 38

nuclear transfer, 40-41, 64

P

Parasites

animal health and welfare, 105

insect, 88, 89

food safety, 62

xenotransplantation, 56

Pathogens, 6, 49

see also Infectious diseases

antibiotic resistance, 23, 44-45

bacterial, 7, 19, 23, 37, 44-45, 56, 62, 65

feces, 7, 62, 65

food safety, 7, 62, 65

exogenous pig viruses, 55-58

feral species, 83-84, 87

knockout techniques, 37, 38

nuclear transfer, 40

porcine endogenous retroviruses (PERVs), 6, 52, 59-60

xenotransplantation, 17, 37, 44, 55-60, 103-104

Political issues, 13-14, 23-24

see also Regulatory issues

religious concerns, 23-24

scientific uncertainty, 13, 14, 110, 111-112

Polymer chain reaction, 59

Porcine endogenous retroviruses (PERVs), 6, 52, 59-60

Novel proteins, 7, 16-17, 66-71, 81, 85, 102, 103

Nuclear transfer

insects, 21

pharmaceuticals, 52-53

viral, 6, 19, 47, 52-53

xenotransplantation, 55-60

PERVs, see Porcine endogenous retroviruses

Pharmaceuticals, 12, 51-54, 65, 85

animal health and welfare, 102

antibiotics, 17, 19, 23, 78

knockout/knockin techniques, 38

resistance to, 23, 44-45, 47, 52, 89

committee study at hand, methodology, 1, 4, 6, 7, 31-32

food safety and, 62-63, 67

gene expression, 52, 67, 69

hormones, 51, 53

poultry and eggs, 51, 52, 53, 81

regulatory issues, 52, 111, 113, 114

vaccines, 51-52, 56, 65

Pigs, 10, 16, 39, 117

animal health and welfare, 97, 99, 100, 102, 103-104, 105

Poultry and eggs, 7, 8, 10, 16, 20-21, 39, 66, 117

allergenicity and hypersensitivity, 68

animal health and welfare, 105

avian leukemia, 47

feral species, 83

pharmaceutical production, 51, 52, 53, 81

steroids, 27

viral vectors, 46, 47, 52, 53

Primordial germ cells, 35

Proteins, 7, 12, 78

allergenic, 67, 68-70

food safety, 66-71

insects, 21

knockout techniques, 38

novel proteins, 7, 16-17, 66-71, 81, 85, 102, 103

pharmaceuticals, 51, 67

xenotransplantation, 44

R

Rabbits, 7, 39, 53, 83, 87

Rainbow trout, 21, 30, 82

Ralgro, 27

Regulatory issues, 13-14, 22, 108-109, 113-115, 120

see also Animal and Plant Health Inspection Service, 21

animal health and welfare, 103-104, 112

biopharm animals, 54

committee study at hand, methodology, 1, 3, 4, 31-32

environmental concerns, 87-92, 113, 114-115

food safety, 62, 65-66, 70-71, 111, 113-114, 118

labeling, 118

pharmaceuticals, 52, 111, 113, 114

scientific uncertainty, 111-113, 114

steroids, 27

xenotransplantation, 55-56, 59, 60, 65, 103-104

Religious concerns, 23-24, 116, 118

Reproductive system and processes, 23-27, 77

see also Embryos and embryonic tissue;

Fertility and fertilization

artificial insemination (AI), 4, 9, 12. 19, 23-24, 65, 77, 93-94

porcine endogenous, 6, 52, 59-60

vectors, 45, 46, 47, 52

Risk analysis and assessment, general, 13-14, 92

see also Dose-response assessment;

Environmental concerns;

Exposure;

Food safety;

Human health concerns;

Pharmaceuticals;

Xenotransplantation

committee charge and methodology, 1, 2-3, 13-14, 33

definitional issues, 2-3, 15, 33, 73-75

RNA, 36

see also Retroviruses

animal health and welfare, 93-94, 99

oocytes, 5, 24-25, 31, 35, 38, 40-41, 64

sperm and semen, 5, 19, 22, 31, 32, 34, 35, 63

sterility, 29-30, 88

Research methodology, 34-50

see also Definitional issues;

Risk analysis and assessment;

Theoretical issues

animal models, 5

committee study at hand, 1-3, 13, 14-15, 31-33, 34, 51, 61, 73

animal health and welfare, 2, 3, 4, 32

environmental concerns, 1, 3, 4, 9-11, 32, 73-74

ethical issues, 2, 3, 4, 32

pharmaceuticals, 1, 4, 6, 7, 31-32

regulatory issues, 1, 3, 4, 31-32

risk analysis and assessment, 1, 2-3, 13-14, 33

directed genetic manipulation, 37-38

novel genes, 34-37

nuclear transfer, 39-40

scientific uncertainty, 2-3, 9, 13, 14, 15, 32, 35, 73, 87, 108-110

Retroviruses, 5, 6, 36, 47, 78

concerns about, 43

endogenous, 6, 46, 47, 52, 47, 56, 59-60

exogenous, 47, 56-58

human immunodeficiency virus, 41-42

marker genes, 45

pharmaceuticals, 52

S

Salmon, 10, 11, 16, 31, 90-91, 99-100

Atlantic, 21, 30, 39, 90-91, 113

coho, 16, 91

Scientific uncertainty, 2-3, 9, 13, 14, 15, 32, 35, 73, 87, 108-110

Scrapie, 37

Sheep, 19, 26, 27, 37, 39, 53, 70, 83

animal health and welfare, 94

nuclear transfer, 39

Shellfish, 7, 11, 16, 21, 29-31, 39, 68, 70-71, 92

Social issues, 13, 14, 93, 116

see also Animal health and welfare;

Ethical issues

scientific uncertainty, 110

political issues, 13-14, 23-24

scientific uncertainty, 13, 14, 110, 111-112

see also Legislation;

Regulatory issues

religious concerns, 23-24, 116, 118

Somatic cell nuclear transfer, 5, 18, 39-40, 47-49, 64

animal health and welfare, 100-102

food safety, 61

Sperm and semen, 5, 19, 22, 31, 32

food safety, 63

germline modification, 34

transfection, 35

Stem cells, 5, 34-36, 38, 39-40

Sterility, 29-30

insects, biocontrol, 88

Steroids, 27

T

Theoretical issues, 6, 15-16

see also Definitional issues;

Research methodology

committee study at hand, methodology, 4, 32

scientific uncertainty, 2-3, 9, 13, 14, 15, 32, 35, 73, 87, 108-110

Tissue, 1, 6

see also Embryos and embryonic tissue

pharmaceuticals, 52

transcription, 41

xenotransplantation, 6, 54-60

Toxicity, 7, 61, 65, 66, 71-72

Transcription, 36, 41

Transduction, 6, 52, 52

Transfection, 5, 35-36, 38, 39

Transgenesis, 8, 34-50

pharmaceuticals, 52-53

Transgenic animals, 6, 9-10, 12, 16, 22, 25, 32, 34-50

see also Environmental concerns

animal health and welfare, 94-107

fish, 11, 17, 30, 31

insects, 21, 36

food safety, 61, 65-72

pharmaceuticals, 52, 53-60, 61

Transplant technology, see Xenotransplantation

Transposons, 5, 36-37, 46-47

Triploidy, 30

U

Understanding Risk: Informing Decisions in a Democratic Society, 74-75

The Use of Genetically Modified Animals, 105

V

Vaccines, 51-52, 56, 65

Vectors, 4, 6, 9, 15, 50

insect, 39, 88, 89, 116-117

marker genes, 44-45

pharmaceuticals, 52

viral, 5, 35, 39, 41-42, 45, 46, 47, 52-53

gene expression, 41-42, 47, 60

poultry and eggs, 46, 47, 52, 53

retrovirus, 45, 46, 47, 52

Viruses, 6, 44, 88

see also Retroviruses

animal health, 22-23

endogenous proviruses, 6, 41-42, 43, 52-53, 59-60

exogenous pig viruses, 56-58

feral species, 87

food safety, 67

pathogens, 6, 19, 47, 52-53

transfection, 5, 35-36, 38, 39

vectors, 5, 35, 39, 41-42, 45, 46, 47

gene expression, 41-42, 47, 60

poultry and eggs, 46, 47, 52, 53

retrovirus, 45, 46, 47, 52

xenotransplantation, 56

Vitamins, 8, 67

W

Wildlife, see Feral species

World Health Organization, 69

X

Xenotransplantation, 6, 10, 12, 17, 44, 51, 54-60

animal health and welfare, 103-104

food safety and, 63, 65-66

infectious diseases, 55, 56-60

immune system, 37, 44, 55, 103

international perspectives, 56, 103

knockout techniques, 37

pigs, 17, 37, 44, 55-60, 103-104

regulatory issues, 55-56, 59, 60, 65, 103-104