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
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US EPA EPA Toxic Substance Control Act Follow the quidelines of the US Federal enables EPA to regulate commercialization Insecticide,Fungicide,and Rodenticide of GM organisms that possess pesticidal Act activities controls allowable residues levels of requires EPA to review and issue a permit herbicides in areas planted with GM- for field testing of a protectant>10 derived herbicide resistant crops hectares of land before commercialization,EPA reviews the application and asks for public opinion and scientific expert feed-back Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA ensures the food safety and wholesomeness for follows the guidelines of the Food,Drug all foods excluding those regulated by the USDA and Cosmetic Act of 1938 agencies that regulate GM foods has authority to remove by seizure and Center for Food Safety and Applied forced recall any food that does not Nutrition meet the safety standards Center for Veterinary Medicine relies on companies to notify them Center for Drug Evaluation and Research before marketing new items
4/6/2017 6 Regulation of GM Foods in the US EPA • Follow the guidelines of the US Federal Insecticide, Fungicide, and Rodenticide Act - controls allowable residues levels of herbicides in areas planted with GMderived herbicide resistant crops Regulation of GM Foods in the US EPA • Toxic Substance Control Act - enables EPA to regulate commercialization of GM organisms that possess pesticidal activities - requires EPA to review and issue a permit for field testing of a protectant > 10 hectares of land - before commercialization, EPA reviews the application and asks for public opinion and scientific expert feed-back Regulation of GM Foods in the US FDA • ensures the food safety and wholesomeness for all foods excluding those regulated by the USDA • agencies that regulate GM foods - Center for Food Safety and Applied Nutrition - Center for Veterinary Medicine - Center for Drug Evaluation and Research Regulation of GM Foods in the US FDA • follows the guidelines of the Food, Drug and Cosmetic Act of 1938 • has authority to remove by seizure and forced recall any food that does not meet the safety standards • relies on companies to notify them before marketing new items
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA Once notification of new product is addresses labeling requirements of food received: oponents of GM foods cite that these FDA provides consultation to help foods are misleading or misbranded developers of new food products to according to the FDCA meet safety requirements FDA does not regulate GM foods as new products or new food additives goal is to evaluate safety before product becomes commercial FDA does not considered these products mislabeled or misbranded Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA requlation of GM foods is based on "substantial addresses labeling requirements of food equivalence" if the GM food has significantly altered 1992 policy-Statement of Policy:Foods Derived nutritional properties from its conventional from New Plant Varieties counterpart,then it needs to be reflected provides guidance to the industry regarding in the label FDA's position on biotechnology and GM foods 、 FDA encourages yoluntary labeling of foods basic premise is that there are no special indicating if they are GM foods labeling requirements for GM foods as they are not seen to be different if they are substantially equivalent to their conventional counterparts
4/6/2017 7 Regulation of GM Foods in the US FDA • Once notification of new product is received: - FDA provides consultation to help developers of new food products to meet safety requirements - goal is to evaluate safety before product becomes commercial Regulation of GM Foods in the US FDA • addresses labeling requirements of food - oponents of GM foods cite that these foods are misleading or misbranded according to the FDCA - FDA does not regulate GM foods as new products or new food additives - FDA does not considered these products mislabeled or misbranded Regulation of GM Foods in the US FDA • addresses labeling requirements of food - if the GM food has significantly altered nutritional properties from its conventional counterpart, then it needs to be reflected in the label - FDA encourages voluntary labeling of foods indicating if they are GM foods Regulation of GM Foods in the US FDA • regulation of GM foods is based on ”substantial equivalence” • 1992 policy – Statement of Policy: Foods Derived from New Plant Varieties - provides guidance to the industry regarding FDA’s position on biotechnology and GM foods - basic premise is that there are no special labeling requirements for GM foods as they are not seen to be different if they are substantially equivalent to their conventional counterparts
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA M food undergo a safety assessment that compares GM Too Example where substantial equivalence was not found- nts with r molecular. StarLink corn GM corn produces an insecticidal protein from B. .the or effecr of the Thuringiensis 2.Evalutation of the source,identity,function,and stability of the introduce genetic material 3.Analytical studies to determine effects on composition of but pproved for in the food StarLink corn found in taco shells 4.Evaluation of GM substance in food 5.Animal feeding studies or other toxicological tests are done when the analytical methods cannt resolve safety concerns Removed from the market in 2000 Some genetically modified foods Regulation of GM Foods in the US GM food regulation summary:fictional example Very Cherry Company developed GM cherries that include new gene "gene R" Gene enhances the red color but does not affect the products safety as determined by field tests and molecular/chemical evaluations Product was tested on land and shown not to pose an environmental hazard Starlink corn Data was presented to FDA,USDA,and EPA and an exemption was requested
4/6/2017 8 Regulation of GM Foods in the US FDA • GM food undergo a safety assessment that compares GM foods to conventional counterparts with respect to molecular, compositional, toxicological, and nutritional data 1. Evaluation of the purpose or technical effect of the modification 2. Evalutation of the source, identity, function, and stability of the introduce genetic material 3. Analytical studies to determine effects on composition of the food 4. Evaluation of GM substance in food 5. Animal feeding studies or other toxicological tests are done when the analytical methods cannt resolve safety concerns Regulation of GM Foods in the US FDA • Example where substantial equivalence was not found – StarLink corn - GM corn produces an insecticidal protein from B. Thuringiensis - Protein digestion and heat stability tests showd that a unique Bt protein was produced and was seen as a potential human allergen - Not approved by FDA but was approved for use in animal feed by EPA - StarLink corn found in taco shells - CDC provided evidence of the corn as potential allergen linking it to 51 illnesses though inconclusively - Removed from the market in 2000 Regulation of GM Foods in the US GM food regulation summary: fictional example • Very Cherry Company developed GM cherries that include new gene ”gene R” • Gene enhances the red color but does not affect the products safety as determined by field tests and molecular/chemical evaluations • Product was tested on land and shown not to pose an environmental hazard • Data was presented to FDA, USDA, and EPA and an exemption was requested
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US GM food regulation summary:fictional example GM food regulation summary:fictional example ‘5 ee6 Tequlane FDA evaluated the data and sent a letter regarding the product status FDA ensures the safety and wholesomeness of the product for human consumption FDA does not approve the products but Very Cherry Co.notified the FDA of the new states"all relevant scientific questions have been addressed" product and proceeded with a two-step process No reason to prevent marketing of their discussion of the relevant safety issues product submission of a report on safety assessment Biotechnology versus Organic Agriculture Biotechnology versus Organic Agriculture Organic Food Protection Act of 1990 Organic Food Protection Act of 1990 created under the Farm Bill -authorized a new USDA program-National Organic Program establishes national standards that govern .established organic standards and marketing of organic agricultural products definitions ensures that consumers receive products .placed Agricultural Marketing Service that meet consistent standards within the USDA as agency to oversee NOP regulates interstate commerce of organic prohibits use of any GM ingredient in the food product label as organic Organic standards are expressed in Title 7, part 205 of the Code of Federal Regulations
4/6/2017 9 Regulation of GM Foods in the US GM food regulation summary: fictional example • Since the product does not produce any pesticides, the EPA would not regulate it • FDA ensures the safety and wholesomeness of the product for human consumption • Very Cherry Co. notified the FDA of the new product and proceeded with a two-step process - discussion of the relevant safety issues - submission of a report on safety assessment Regulation of GM Foods in the US GM food regulation summary: fictional example • FDA evaluated the data and sent a letter regarding the product status • FDA does not approve the products but states ”all relevant scientific questions have been addressed” • No reason to prevent marketing of their product Biotechnology versus Organic Agriculture • Organic Food Protection Act of 1990 - created under the Farm Bill - establishes national standards that govern marketing of organic agricultural products - ensures that consumers receive products that meet consistent standards - regulates interstate commerce of organic food Biotechnology versus Organic Agriculture • Organic Food Protection Act of 1990 - authorized a new USDA program – National Organic Program established organic standards and definitions placed Agricultural Marketing Service within the USDA as agency to oversee NOP prohibits use of any GM ingredient in the product label as organic - Organic standards are expressed in Title 7, part 205 of the Code of Federal Regulations
4/6/2017 Biotechnology versus Organic Agriculture Biotechnology versus Organic Agriculture Legal issues-NOP and biotechnology Legal issues-NOP and biotechnology If a producer adheres to all aspect of the Organic certifying agents are USDA trained NOP requlations,including no GM seeds,but a and ensure that the organic operations follow certifying agent finds GM material in the the OFPA and NOP regulations crop,then the crop may still be "certified"as If all requlations are followed,then organic detectable residue does not constitute a violation of the regulations Organic certification is"processed-based" and not "product-based" When unintended GM substances are found, certifying agents work with the or This is opposite to FDA's view on GM food producers to find the source of the which is "product-based" substance Common Examples of GM Products Common Examples of GM Products Flavr Savr Tomato Flavr Savr Tomato .Developed by Calgene,Inc California Concept:flavr savr tomato First GM crop to be commercialized in the US -supress the enzymes responsible for ripening Concept:traditional commercial tomatoes polygalacturonase degrades pectin in the cell wall picked green to prevent damage during transportation without PG the fruit remains firm and artificial ripening is avoided ripened by ethylene gas,a growth hormone Result:vine-ripen flavor without the softening
4/6/2017 10 Biotechnology versus Organic Agriculture Legal issues – NOP and biotechnology • If a producer adheres to all aspect of the NOP regulations, including no GM seeds, but a certifying agent finds GM material in the crop, then the crop may still be ”certified” as organic • Organic certification is ”processed-based” and not ”product-based” • This is opposite to FDA’s view on GM food which is ”product-based” Biotechnology versus Organic Agriculture Legal issues – NOP and biotechnology • Organic certifying agents are USDA trained and ensure that the organic operations follow the OFPA and NOP regulations • If all regulations are followed, then detectable residue does not constitute a violation of the regulations • When unintended GM substances are found, certifying agents work with the organic producers to find the source of the GM substance Common Examples of GM Products Flavr Savr Tomato • Developed by Calgene, Inc California • First GM crop to be commercialized in the US • Concept: traditional commercial tomatoes - picked green to prevent damage during transportation - ripened by ethylene gas, a growth hormone Common Examples of GM Products Flavr Savr Tomato • Concept: flavr savr tomato - supress the enzymes responsible for ripening polygalacturonase degrades pectin in the cell wall - without PG the fruit remains firm and artificial ripening is avoided - Result: vine-ripen flavor without the softening