GM Foods: Safety and Regulation Robert McGorrin OSU

GM Foods: Safety and Regulation Robert McGorrin OSU

GM Foods: Safety and Regulation Robert McGorrin OSU Dept. Food Science & Technology BIO 430/530 FS 430/530 Biotechnology: Agricultural, Food, Nat. Resource Issues October 25, 2005 Overview Background on Food Biotechnology Genetically Modified (GM) Foods: Consumer attitudes, potential benefits How are GM foods regulated? Food safety perspectives: GM foods vs. traditional Labeling issues for GM foods

Background: Food Biotechnology Goals Propagate / selectively breed plants and animals to excel in some desirable property or characteristic Develop plants and animals which: Grow faster Produce more, increased fertility Better quality Use resources more efficiently Resistance to disease, environmental stress

Food Biotechnology Traditional examples Classical plant breeding Rennet enzyme (cheesemaking) Yogurt starter bacteria cultures Enology (wine making) Brewing science (malted barley) Breadmaking

Food Biotechnology: Traditional Breeding vs. GM Traditional breeding Exchanging all genetic material from two related plants Hybridization In-vitro fertilization

Tissue culture Genetic modification (GM) Moving one or two genes selectively Recombinant DNA (rDNA) technology Cell fusion Microencapsulation

Common approach: Insertion of modified genes from same species Infrequent strategy: Gene movement cross-species Food Biotechnology Biotechnology is not new; farmers have crossbred and hybridized plants for centuries Modern genetic modification technologies provide new tools to target specific food characteristics for enhancement Recombinant rDNA biotechnology offers the potential to make the process more precise Recent Examples: GM Foods

Recent examples (transgenic engineering) Milk from cows receiving Bovine Somoatotropin (growth hormone, rGBH) Chymosin enzyme (cheesemaking) Calgenes FlavrSavr tomatoes Papaya (resistance to ringspot virus) High oleic / low linolenic soybean oil, sunflower oil Insecticide-resistant corn Bt (Bacillus thuringeinsis) corn Monsanto Cry9C (insecticidal protein) Starlink corn Aventis Herbicide-tolerant soybeans (Round-up ready) Existing Genetically Engineered Food Crops Primary Benefit: Agricultural Production Food

Engineered Traits Gene Source Canola Chicory Corn Papaya Potato Soybean Squash Sugarbeet herbicide resistance facilitates hybridization insect resistance

ringspot virus resistance insect resistance herbicide resistance virus resistance virus resistance bacteria, virus bacteria bacteria (Bt) bacteria, virus bacteria (Bt), virus bacteria, virus bacteria, virus bacteria, virus Genetically-Modified Foods Approximately 70% of foods in U.S. supermarkets are produced by genetic

modification (not just fresh fruits and vegetables in Produce section) Soybean Lecithin (emulsifier used in chocolate) Oil (mayonnaise, pourable salad dressings, margarine) Meat substitutes (e.g. bacon bits, breakfast sausage analogs) Corn High fructose corn syrup (soft drinks, candy, fruit juice cocktails) Corn starch (puddings, mixes, gravies, cold cereals Chymosin enzyme Cheese manufacture

Aspartame (artificial sweetener GMO bacteria) Soft drinks, candy, fruit spreads, fruit in yogurt Future Consumer Benefits: GM Foods Fifty varieties of GMO-enhanced crops have been approved in the United States (2000) Food industry is the recipient of university and life science company research on new food crops and ingredients: Increased nutrients (proteins, vitamins, minerals) and healthy fatty acid profiles (lower levels of saturated fats) in fruits, vegetables, grains Ripening / freshness extension for fruits and vegetables; better taste

Vitamin A / -carotene enhancement (Golden rice) Modified potatoes with more solids content, permitting less oil absorption during manufacture of French fries and potato chips Vitamin C-enhanced strawberries, sweet potatoes Vitamin E-enhanced canola oil Allergen-free peanuts and soybeans Higher antioxidant levels in tomatoes Caffeine-free coffee beans Once consumers are able to enjoy the direct benefits of these new GMO foods, debate may diminish about the risks and benefits of this technology. Regulation of GM Foods What is the regulatory process for developing and marketing new GM foods? U.S. Food Regulations

The Federal Food, Drug, and Cosmetic Act gives the FDA jurisdiction to regulate that foods are safe, wholesome, and fairly represented / marketed to the public The regulation of food safety centers around the legal aspects of adulteration:

Poisonous or deleterious substances mercury in canned fish Avoidable contaminants plant stems in spices Filthy, putrid, or decomposed substances mold, insect parts Containers plastic packaging residues Unfit for food tough and rubbery clams Sanitation / Good manufacturing practices time, temperature, pH monitoring for preventing microbial contamination of acidified foods Foods that are adulterated, misbranded, or sold without required pre-market approval are subject to a recall (removal from commerce) by FDA The GM Food Development Process TRAIT DISCOVERY Early-stage risk analysis PRODUCT DEVELOPMENT Advanced risk analysis

SAFETY ASSESSMENT Regulatory approval COMMERCIALIZATION USDA EPA FDA The GM Regulatory Triangle USDA - APHIS U.S. Department of Agriculture, Animal & Plant Health Inspection Service EPA - Environmental Protection Agency FDA - Food & Drug Administration GM Food Approval Process 1. Biosafety Review Committee Scientific expert panel (follows 1994 NIH Health Guidelines * for Research Involving Recombinant DNA Molecules) 2. USDA/APHIS Protects agriculture against invasive GM species which may promote infestation by plant pests or diseases - Reviews greenhouse facilities for standards & inspections - Authorizes field trials - Authorizes transport for field trials - When ready for commercialization, applicants request * determination of non-regulated status * Opportunity for public input GM Food Approval Process

3. EPA Regulates plants and microbiological organisms which produce pesticidal substances (insecticides, herbicides) - Reviews effects on environment (toxicity, residuals) - Approves experimental use permits - Authorizes product registration * * * 4. FDA Ensures the safety of food and feed products, including those derived from new plant varieties - Voluntary pre-market consultation - Regulates new foods (genetic sources and functions) - Monitors food composition, altered nutritional profiles

- Assesses potential food toxicants, allergens * Opportunity for public input USDA Food Safety Assessment of GM Foods USDA-APHIS: Early field testing of genetically engineered plants under plant test statutes Detailed environmental assessments required before issuing permits; scientific peer-review Genetic material is stably integrated Plant modification does not contain genetic material derived from an animal or human pathogen Function of genetic material is known, and its expression does not result in plant disease Introduced genetic material does not produce an infectious entity, or encode substances likely to be toxic to nontarget

organisms likely to feed on the plant New GM sequences do not pose significant risk for creating a new plant virus In 1993, the permit application system was replaced by a notification system FDA Food Safety Initiative Surveillance Inspections Coordination Risk Assessment Research

FDA Safety Assessment of GM Foods Focuses on the following areas: Safety and nutritional value of newly-introduced proteins Identity, composition, and nutritional value of modified carbohydrates, fats, or oils Concentration and bioavailability of important nutrients for which a food crop is consumed The potential of food allergens to be transferred from one food source to another Toxins characteristic of host and donor plants Big-Eight Food Allergens

Peanuts and peanut products Shellfish (shrimp, crab, lobster, crayfish) Fish (finfish) Eggs and egg products Milk and dairy products (cheese, yogurt, cultured) Tree nuts (almonds, walnuts, pecans, Brazil nuts, hazelnuts) Soybeans and foods made with soy protein (tofu) Cereals containing gluten (wheat, rye, barley, oats) Allergenic proteins tend to be resistant to digestion, and stable to food processing,

particularly heat processing Source: S. L. Taylor and S. L. Hefle, Food Technology 55, 68-83 (2001) Substantial Equivalence Compares foods (food ingredients) from genetically-modified crops to their conventional counterparts Origin of genes Agronomic parameters Composition (key nutrients / anti-nutrients) Consumption Relative safety

Possible Outcomes Substantially equivalent to conventional counterpart: no no further further testing testing Substantially equivalent to conventional counterpart except for introduced trait(s) focus focus assessment assessment on on trait(s) trait(s) // gene gene product(s) product(s) Not substantially equivalent to accepted food or

food component: combined combined nutritional nutritional // toxicological toxicological assessment assessment Compositional Analyses to Establish Substantial Equivalence (Corn Example) Evaluate EvaluateKey: Key: --Nutrients Nutrients --Vitamins Vitamins

--Minerals Minerals --Anti-nutrients Anti-nutrients --Toxicants Toxicants --Allergens Allergens --Others Others List Listdepends depends on oncrop crop

Grain - Forage Protein - Protein Fat - Fat Fiber - Fiber Starch Amino acid composition Fatty acid composition Ash Sugars Calcium Phosphorous

Safety Assessment Approach Gene / Protein Food / Feed Safety Gene(s) Source(s) Molecular characterization Insert / copy number / gene integrity Protein(s)

History of safe consumption Function / specificity / mode-of-action Levels Toxicology / allergenicity Amino Acid homology Digestibility Acute oral toxicity Clinical Substantial Equivalence Crop Characteristics Morphology Yield

Food / Feed Composition Proximate analysis Key nutrients Key anti-nutrients Feed performance studies Wholesomeness Courtesy: Steve Taylor, Univ. of Nebraska Food Safety The fundamental question: Are foods produced via genetic engineering safe and wholesome to eat? Consumer Attitudes: Biotech Foods What, if anything, are you most concerned about when it comes to food safety? (1,000 respondents)

Food handling / prep Disease / contamination Aug-02 Sep-01 Ingredients Packaging Chemicals / pesticides Other Nothing Genetically engineered Dont know 0 5

10 15 20 25 Percent (%) 30 Source: International Food Information Council, 35

40 45 Consumer Attitudes: Biotech Foods What food-related items do you identify as serious health risks? Bacteria Product tampering Pesticide residues Eating past sell/use date Antibiotics/hormones Supermarket handling Biotech foods Irradiated foods 0 20

40 60 80 100 Percent (%) Source: Food Marketing Institute, Wash. DC, Consumer Attitudes and the Supermarket, 2003 FDA Perspective: GM Foods (1992) After lengthy debate, industry researchers and government regulators concluded that biotech crops and food

ingredients do not compositionally differ in any substantial way from ordinary food products Therefore, they should be regulated by the same standards applied to non-GM crops and foods Food Industry Perspective: GM Foods Responds to consumer demand Mostly remains neutral on the use of biotechnology to enhance whole and processed foods Supports substantial equivalence scientific viewpoint In some cases, industry has rejected GM food ingredients in response to perceived consumer

opinion to protect market share (Frito-Lay, Beechnut, Ben & Jerrys) Food Professional and Trade Perspective: GM Foods Grocery Manufacturers of America, Institute of Food Technologists, Center for Science in the Public Interest, American Medical Association Based on the perspective of industry researchers, government regulators, and independent scientists who have studied the safety and applications of modern biotechnology Overwhelming verdict is that GM technology is safe, and offers a multitude of food benefits: Lower cost Better tasting Healthier, more nutritious

Abundant food supply to meet global population needs Scientific Endorsements: GM Foods Pro Institute of Food Technologists American Dietetic Association American Medical Association The National Research Council Center for Science in the Public Interest U.S. National Academy of Sciences World Health Organization European Research Commission International Food Information Council

Trade Associations Grocery Manufacturers of America National Food Processors Association Scientific Opponents: GM Foods Con Union of Concerned Scientists Foundation on Economic Trends Center for Food Safety Clubs & Trade Associations Organic Trade Association Sierra Club Greenpeace (for an alternative view, see Patrick Moore

GM Foods: Critics Perspective Genetic engineers cannot control with precision where genetic material will be inserted into a host plant, and how it will interact with other genes Scientists do not fully understand the impact that genetic changes can have on nutrition, toxicity, and other food properties Genetic manipulations may permit wider spread of allergenic proteins in foods Unintended ecological consequences as superweeds, oversize fish, rapidly-evolving plant viruses Food Industry Response: GM Foods No other foods in history have been tested and observed as diligently as those developed from modern biotechnology

For more than two decades before approval for the consumer market, GM crops and their derivatives were laboratory- and fieldtested to ensure safety for human and animal consumption Global Regulatory Mechanisms Regulations differ greatly in scale and implementation: Industrialized countries (US, Japan) extremely restrictive; 71% of transgenic crop field trials from 1986-1999 were in US, Canada Developing countries virtually non-existent New European Union regulations of GM foods took effect on April 18, 2004. Requires labeling if > 1% GM Dealing with such disparities will become increasingly important with growth in international trade, and need for intellectual protection

Food Safety and GM Corn Monsanto first develops Bt corn with Cry1Ab protein as insect toxin Aventis pursues development of StarLink corn with Cry9C protein, an alternative insect toxin Allergen testing showed that Cry9C was unlikely to be an allergen, since it does not share amino acid, protein structure similarities with known allergens Unlike other Cry proteins, Cry9C is not readily digestible in simulated gastric conditions, and is stable at 90C In 1998, EPA registration required that StarLink corn was to be restricted solely to animal feed uses Food Safety

and GM Corn The existing U.S. grain storage and distribution system was incapable of adequate grain segregation, identity preservation. The EPA affirms that allergenicity risks are extremely low In Fall, 2000 Kraft recalled 2.5 million boxes of Taco Bell taco shells made using corn contaminated with StarLink corn. Total industry recall costs: several $10 million. Aventis has asked the EPA to reconsider Cry9Cs alllergenicity in light of new data it offered, and to rule it safe for human consumption. In July 2001, EPA ruled that there was inadequate information to establish a tolerance (legal residue limit) for use in human food products. Aventis voluntarily withdrew Starlink. Brazil Nut Saga Pioneer Hi-Bred International Tried to correct the methionine deficiency in

soybeans Brazil nuts rich in methionine; Brazil nut storage protein expressed in transgenic soybean successfully increases methionine content But, was the Brazil nut storage protein an allergen? Brazil Nut Saga Testing of Brazil nut storage protein (Univ. of Nebraska / Univ. of Wisconsin) Recruited 9 subjects with Brazil nut allergies Of the 9, 8 had antibodies that recognized the Brazil nut storage protein as an allergen Three subjects were skin-prick tested with the Brazil nut storage protein The protein elicited an allergic response in all 3

Brazil Nut Saga Pioneer Hi-Bred International did the right thing and discontinued product development, notified FDA Still, however, negative publicity resulted for Pioneer Jeremy Rifkin/ USA Today editorial Food Labeling Should GM foods be labeled? GMO Free! GM Labeling FDA only requires labeling of rDNA technologyderived foods that differ significantly in composition, nutritional value, or safety from

their conventional counterparts Labeling Debate: Pro Arguments for Labeling Consumers right to know to make purchasing decisions Consumer polls support labeling Failure to label may be interpreted as trying to cover-up negative attributes of these foods FDA requires labeling of irradiated food and food ingredients, which it claims is compositionally similar to non-irradiated Without mandatory labeling, reverse labeling (made without GMOS) is inevitable Consumers Union, Campaign to Label Genetically Engineered Foods, Greenpeace National Organic Program Definition

Allows organic foods label to be used for foods that apply traditional breeding processes to produce genetic modification Excludes recombinant DNA techniques and methods to achieve gene deletion, gene doubling, introduction of a foreign gene, and changing of gene positions Labeling Debate: Con Arguments against Labeling Current government regulations are sensible. Genetically engineered foods are compositionally the same as their conventional counterparts. Theres nothing to label. Mandatory labeling is over-regulation. Consumers have other choices (e.g., organic foods) and the marketplace is working. There are no marketed gene-altered foods containing allergens

Mandatory labels would wrongfully imply that safety or nutritional value has been compromised in GM foods, and could lead to consumer confusion about them. Requiring new labeling would raise food costs. Grocery Manufacturers Assn., Oregon Alliance for Better Foods, National Food Processors Assn. Analytical Testing In general, rDNA is not detectable in highly heat-treated foods, hydrolyzed plant proteins, starch derivatives, and refined oils from GM food crops Two common analytical methods for GM foods: Polymerase Chain Reaction (PCR) method: Detects genetically modified DNA sequences. Qualitative test, $250 $600 per sample Enzyme Linked Immunosorbent Assay (ELISA) test: Measures levels of proteins expressed by inserted DNA sequences. Quantitative test, $75 $100 per sample

Both require trained staff and specialized equipment. Sample turnaround times for results are typically 3-5 days Because tests are extremely sensitive, risk of crosscontamination can result in false-positives Conclusions The GM food issue is highly complex Researchers agree that there are legitimate and valid arguments on both sides of the GM issue Additional scientific discourse is essential to find common ground that would allow new technology to be developed and adopted Such actions will be in the best interests of society Conclusions Plant biotechnology products must meet

stringent performance standards during development Continuous regulatory oversight occurs throughout development and the full authorization process Candidate genes / proteins are assessed prior to tranformation All products are thoroughly assessed for food, feed, and environmental safety prior to regulatory approval Conclusions Food/feed safety is based on substantial equivalence and safety of expressed proteins Proteins currently produced in plants have a history of safe use

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