4/6/2017 Introduction Guide to US Food Laws Fpfr下mN Much debate around the and Regulations costs versus benefits of SECOND EDITION producing genetically Chapter 10 PatriciaA.Curtis modified (GM)crops and Biotechnology and food. Genetically Modified Agricultural Crops and Food WILEY Blackwall Big Rise in U.S,Biotech Crops Introduction 69 Alliance for Bio-Integrity v.Shalala Plaintiff argued for for mandatory GM labeling that GM foods should undergo the same testing requirements as food additives as they are "materially changed"and have potentially unidentified health risk that FDA did not follow the Administrative Procedures Act in formulating and disseminating its policy on GM foods
4/6/2017 1 Chapter 10 Biotechnology and Genetically Modified Agricultural Crops and Food Introduction • Much debate around the costs versus benefits of producing genetically modified (GM) crops and food. Introduction Alliance for Bio-Integrity v. Shalala • Plaintiff argued for - for mandatory GM labeling - that GM foods should undergo the same testing requirements as food additives as they are "materially changed" and have potentially unidentified health risk - that FDA did not follow the Administrative Procedures Act in formulating and disseminating its policy on GM foods
4/6/2017 Introduction Introduction Alliance for Bio-Integrity v.Shalala Debate is focused on 3 issues Federal district court 1.Are GM crops and food safe for human health? -rejected all arguments 2.Are they safe for the environment? 、 found that the FDA's determination that GMO's are Generally Recognized as Safe was 3.e poduof modem neither arbitrary nor capricious gave respect to the FDA's process on all issues To date,consumption of GM crops or GM foods has not been correlated or linked to amy health gave future plaintiffs little legal recourse to problems for animal or humans challenge the FDA's policy on GM foods Benefits and costs of using genetically modified or genetically Introduction engineered foods Benefits Costs Numerous groups have filed cases alleging Enhanced quality and taste Human health impact (introduction of allergens and antibiotic "fraud-on-the-FDA"since the introduction of resistance】 GM foods in 1996 Effects on non-targeted organisms FDA bottom line statement Improved health and resistance to GM food does not depend on the methods by which the food was developed,but rather regulation rests on the characteristics of creaadamdmprovedrmtrensRrd2are2pbiaiono the crop/food and its intended use or the Drought resistance crops Animal stress from over-productior use of its components ecigiagrersontea Improved food security Potential skewed interest of rich countries
4/6/2017 2 Introduction Alliance for Bio-Integrity v. Shalala • Federal district court - rejected all arguments - found that the FDA's determination that GMO's are Generally Recognized as Safe was neither arbitrary nor capricious - gave respect to the FDA's process on all issues - gave future plaintiffs little legal recourse to challenge the FDA's policy on GM foods Introduction Debate is focused on 3 issues 1. Are GM crops and food safe for human health? 2. Are they safe for the environment? 3. How do we regulate products of modern biotechnology? To date, consumption of GM crops or GM foods has not been correlated or linked to any health problems for animal or humans Introduction • Numerous groups have filed cases alleging ”fraud-on-the-FDA” since the introduction of GM foods in 1996 • FDA bottom line statement GM food does not depend on the methods by which the food was developed, but rather regulation rests on the characteristics of the crop/food and its intended use or the use of its components Benefits Costs Enhanced quality and taste Human health impact (introduction of allergens and antibiotic resistance) Increased productivity (reduced maturation time) and yield Effects on non-targeted organisms Improved health and resistance to disease and pests (use less pesticide and herbicides) Food monopolies by a few companies Increased and improved nutrients Biopiracy (foreign explotation of natural resources) Drought resistance crops Animal stress from over-production Improved feed conversion (meat producing animals) No world-wide labeling standards (mix GM with non-GM products) Improved food security Potential skewed interest of rich countries Benefits and costs of using genetically modified or genetically engineered foods
4/6/2017 Biotechnology,Genetically Modified and Genetic Engineering ·Biotechnology ANIMAL BIOINFORMATICS GENOMICS/ AGRICULTURE PROTEOMICS application of scientific knowledge to living organisms or their constituents for ENERGY在 ENVIRONMENT MGM了 practical purposes BIOTECHNOLOGY utilization of biologically-derived molecules,structures,cells or organisms to carry out a specific function DIOGNOSTICS Biotechnology,Genetically Modified and Genetic Engineering Old Biotechnology Genetically modified ·Genetic engineering Tallor made vestock bres medical. refer to an organism(animal,plant, Genetic theropy bacteria)that has been exposed to a Tree grafted-inserted technique that changes its genetic makeup or DNA generally thought of as modern food GMO germ science tools Cell clone reality is that people have been rmation New Biotechnology manipulating food since ancient times
4/6/2017 3 Biotechnology, Genetically Modified and Genetic Engineering • Biotechnology - application of scientific knowledge to living organisms or their constituents for practical purposes - utilization of biologically-derived molecules, structures, cells or organisms to carry out a specific function Biotechnology, Genetically Modified and Genetic Engineering • Genetically modified • Genetic engineering - refer to an organism (animal, plant, bacteria) that has been exposed to a technique that changes its genetic makeup or DNA - generally thought of as modern food science tools - reality is that people have been manipulating food since ancient times
4/6/2017 Biotechnology.Genetically Modified and Biotechnology,Genetically Modified and Genetic Engineering Genetic Engineering Genetically modified ·Gene splicing ·Genetic engineering ·Recombinant DNA 、 Wine was produced as early as the Bronze Combine genetic elements of two or more Age(6000 BCE) living cells to produce desirable traits Bread was first leavened over 4000 years 、 Example:dairy cows have been genetically ago using yeast modified to produce more milk without Animals have been bread to produce the costing the farmer more strongest or most productive Critics say that these changes are against nature and do not provide any advantages to the consumer S2 Regulation of GM Foods in the US + General policy of the US Government regarding new technology Manufacturer must demonstrate to the appropriate agencies that exposure to the new Bacterin Cell technology shows no significant risk to humans, animal-producing foods and the environment Regulators focus on whether or not the modified crops or foods are compatible with nature Three agencies oversee the regulation of GM foods FDA USDA EPA
4/6/2017 4 Biotechnology, Genetically Modified and Genetic Engineering • Genetically modified • Genetic engineering - Wine was produced as early as the Bronze Age (6000 BCE) - Bread was first leavened over 4000 years ago using yeast - Animals have been bread to produce the strongest or most productive Biotechnology, Genetically Modified and Genetic Engineering • Gene splicing • Recombinant DNA - Combine genetic elements of two or more living cells to produce desirable traits - Example: dairy cows have been genetically modified to produce more milk without costing the farmer more - Critics say that these changes are against nature and do not provide any advantages to the consumer Regulation of GM Foods in the US General policy of the US Government regarding new technology • Manufacturer must demonstrate to the appropriate agencies that exposure to the new technology shows no significant risk to humans, animal-producing foods and the environment • Regulators focus on whether or not the modified crops or foods are compatible with nature • Three agencies oversee the regulation of GM foods FDA USDA EPA
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US USDA USDA Responsible for safety and wholesomeness of Two USDA agencies are responsible for GM crops meat,poultry and egg products and foods 1.Animal and Plant Health Inspection Service Regulates potential agricultural plant pests (APHIS) and noxious weeds oversees the Federal Plant Pest Act,which Ensures safety and efficacy of meat- regulates interstate movement,importation producing animals and field testing of GM organisms/products that are not yet proven safe 2.Food Safety Inspection Service(FSIS) Regulation of GM Foods in the US hg inserted into crop EPA Follow the guidelines of the US Federal Insecticide,Fungicide,and Rodenticide Act Regulate the sale,use and testing of plants and microorganisms that produce pesticide substances Example:Bacillus thuringiensis and BT corn,Bt cotton,Bt potatoes Crop is infected by European com borer Pest dies when feeding on any plant part
4/6/2017 5 Regulation of GM Foods in the US USDA • Responsible for safety and wholesomeness of meat, poultry and egg products • Regulates potential agricultural plant pests and noxious weeds • Ensures safety and efficacy of meatproducing animals Regulation of GM Foods in the US USDA • Two USDA agencies are responsible for GM crops and foods 1. Animal and Plant Health Inspection Service (APHIS) oversees the Federal Plant Pest Act, which regulates interstate movement, importation and field testing of GM organisms/products that are not yet proven safe 2. Food Safety Inspection Service (FSIS) Regulation of GM Foods in the US EPA • Follow the guidelines of the US Federal Insecticide, Fungicide, and Rodenticide Act - Regulate the sale, use and testing of plants and microorganisms that produce pesticide substances - Example: Bacillus thuringiensis and BT corn, Bt cotton, Bt potatoes