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GMO* and Food Safety Dr. Ted Labuza Department of Food Science and Nutrition Univ. Of Minnesota St Paul 55108

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Presentation on theme: "GMO* and Food Safety Dr. Ted Labuza Department of Food Science and Nutrition Univ. Of Minnesota St Paul 55108"— Presentation transcript:


2 GMO* and Food Safety Dr. Ted Labuza Department of Food Science and Nutrition Univ. Of Minnesota St Paul * Frankenfoods ???




6 Safety issues over GMO Classic toxicity testing Substantial equivalence Pre-cautionary principal vs risk benefit Identity preservation labeling

7 Poisonous or Deleterious Substances general toxicity carcinogens mutagens teratogens

8 FDA Regulation of GMOs

9 Food Drug and Cosmetic Act 402(a)(1) - a food is adulterated if it contains any poisonous or deleterious substance which may render the food injurious to health

10 Food Drug and Cosmetic Act 402(a)(1) - a food is adulterated if it contains any poisonous or deleterious substance which may render the food injurious to health –Microbial example : pathogens such as E. coli O157:H7

11 Food Drug and Cosmetic Act 402(a)(1) - a food is adulterated if it contains any poisonous or deleterious substance which may render the food injurious to health –Chemical examples : lead, PCBs, dioxin, mercury, –radio-nucleotides, pesticides

12 Food Drug and Cosmetic Act 402(a)(1) - a food is adulterated if it contains any poisonous or deleterious substance which may render the food injurious to health –Relates to unapproved substances added by man intentionally or non- intentionally

13 Food Drug and Cosmetic Act 402(a)(1) - however if not added*, the food is not adulterated if the quantity would not ordinarily render injurious to health example - solanine in potatoes –New level of consumption –More susceptible population * meaning naturally present So could apply to a GMO

14 Questions What level of toxicant is tolerable, if any? What level of toxicant is detectable ?

15 Food Additives Amendment (a)(2) A food is adulterated if it contains any added poisonous or deleterious substance except one that is either: Food Additive (Sec 409) Generally Recognized As Safe 201(s) Color Additive (Sec 706) Pesticide (Sec 408) - clarified as not an additive Note that added means intentional addition so would apply to GMO unless exempt as additive or GRAS

16 Additive Definition 201(s) any substance, the intended use of which may reasonably be expected to result directly or indirectly in its becoming a component or otherwise affecting the characteristics of any food.

17 Additive testing history Based on traditional toxicity testing FDA Red Book st edition LD 50 acute toxicity Sub-acute toxicity Life time chronic feeding trials Safety based on 100th of the level of NOAEL Also applied to GRAS substances

18 Decision process Rodricks Food Tech. March 1996 pg 114 EDI (estimated daily intake) < NRI (negligible risk intake) Assessment –Natural components –Unintentional contaminants –Intentionally added constituents- ADI Added 10x10 fold factor to estimate NRI GRAS related

19 Test design constraints for GMO food Generally max level of % 5 dry solids in test animal diet per day Equivalent to dose of ~2500 mg/Kg /day in 50 g diet for 1 Kg animal If no effect and use 100x factor then ADI = 25mg/Kg/day so in 70 Kg human ~1.8 g/day so if GMO with 95% moisture ~ 1 ounce serving

20 Sec 409 (c)(3) Delaney Clause No regulation shall issue if a fair evaluation before the Secretary (FDA) (a) fails to establish that the proposed use shall be safe provided that no additive shall be deemed safe it it is found to induce cancer when ingested by man or animal or if it is found after tests which are appropriate for their evaluation of the safety of food additives to induce cancer in man or animals

21 Delaney Clause exclusions GRAS substances prior to 1958 Pesticides - FQP Act Dietary supplements (note under NLEA FDA needs to prove unsafe)

22 GRAS Sec 201 (s) Except food additive does not mean such substance that is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate the safety, through adequately shown scientific procedures or in the case of a substance used in food prior to Jan through either scientific procedures or common use in food to be safe under the conditions of its intended use.

23 Natural Carcinogens Mushroom Example Agaratine- DNA breaker at 1.2 mg/70 Kg person present in mushrooms Calculated safe dose < 4 g mushroom per day or 1 meal every 100 days Foods are GRAS so exempt

24 Fmali Herb Inc. v Heckler 715 F 2d 1385, 1982 (DC ND CA 9/15/83) Block list on renshan-fenwang-jiang from Korea Basis not GRAS since not consumed in US prior to 1958 Fmali sues to lift ban Court agrees that GRAS means anywhere in world not just US thus if used can bring in 53 FR /10/88 - substantial use as an ingredient for food by a significant number of consumers

25 GRAS Review 21 CFR 170(f) (1) modified substances of natural biologic origin consumed prior to 1958 but modified afterwards (2) significant alteration of prior 1958 natural substances by breeding and in which the nutritive value or toxicity changes

26 Classical Breeding History UM, NDSU and USDA potato research lab development of improved chipping variety of potato (Lenape) (Zitnak and Johnston Am Potato Jr 47:256-60) Submitted to FDA for approval but found increased solanine level so withdrew from introduction

27 Classical Breeding History Discussion at Hort. Science meeting published in 1975 Spiher A.T. The Growing of GRAS Hort Sci. 10: –Approval based on nutrient level and toxicological levels

28 The Issues What category of food ingredients do GMO based varieties it into ? What safety criteria are needed in testing, ie what are the protocols ? What does substantial equivalence mean? What does precautionary principal mean?

29 1987 National Academy of Sciences Introduction of recombinant DNA- engineered organisms into the environment: Key issues –No evidence of unique hazards –Risks similar to introduction of unmodified organisms or those modified by other methods

30 The FDA Policy 57 FR May 29, 1992 The safety of foods derived from new plant varieties (Note never finalized -guidance to industry) –Basic premise is that plant breeding produces safe foods vs chemicals which may be toxic –Genetic transferred material may be subject to food additive or GRAS process –(DNA itself not a concern IFBC 1990 – Miragila et al 1990 safety assessment of genetically modified food products Microchem J 59;154-9)

31 The FDA Policy 57 FR May 29, 1992 The safety of foods derived from new plant varieties –Toxicant level suggested ^ by 10% and Nutrient level suggested decrease of 10% –Is there a potential allergen ? –Kessler et. al. The safety of foods developed by biotechnology Science 256: –Current working policy - 45 products have been evaluated –12 corn, 7 canola, 6 tomato, 5 cotton, 4 potato –see IFT Expert Report on Biotechnology gmo/gmo.html

32 Basis of policy 402 (a)(1) of FFDC – see Ronk et al Hort Sci 25; Animal feeding studies problematic Animal tests not sensitive as cannot supplement at high enough level Need multidisciplinary assessment process based on –genomic traits –Agronomic and quality analysis –Allergenicity potential –Analysis of toxicants and nutrients Maryanski, J. FDAs policy for Foods Developed from Biotechnology in Genetically Modified Foods: Safety Issues Engle et al Eds. ACS Symposium Series # pgs 12-22

33 Basis of policy 402 (a)(2) of FFDC – will need approval as food additive if introduced protein is different than normal otherwise GRAS –Special attention should be given to potential allergens - see April 1994 FDA conference on Scientific issues related to potential allergenicity in Transgenic Food Crops FDA Docket # 94N-0053 also in 59 FR April 1, 1994

34 OSTP 1994 Coordinated Framework for US Biotechnology Policy –51 FR June 26, 1986 Exercise of Federal oversight – 57 FR 6753 Feb –Use risk based scientific approach rather than process used (ie dont focus on biotech process rather use the standard safety evaluation process)

35 The Genetic Raw Potato Ewan and Pusztai Lancet 354: Oct. 16, 1999 Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on the rat small intestine (insect resistance) crypt hyperpalsia suggested expression of other genes

36 Early Genetic Engineering of GRAS Ingredients in Foods The first round: chymosin –recombinant technology –Inserted gene for calf rennet into E. coli –>80% of world cheese making

37 Early Genetic Engineering of GRAS Ingredients in Foods The first round: chymosin –Deemed to be GRAS –57 FR /3/90 E coli –57 FR :1992 yeast –58 FR : 1993 mold See Flamm E.L. Bio/Technology 9: ; 1991 –Same protein structure –Most impurities removed –Organism destroyed in processing –Anti-biotic resistant marker destroyed

38 Early Genetic Engineering of GRAS Ingredients in Foods High-fructose corn syrup – recombinant enzymes –Bound on reactor bead surface so does not go into food - processing aid –Converts glucose to fructose

39 The first controversy - Monsanto Milk - Recombinant BST or rBGH Neither GRAS nor Food Additive rather It is an approved New Animal Drug

40 Flavor-Savr Tomato Calgene asks for food additive status for enzyme FDA Docket # 90A-0416, 91A-0330 FDA findings –enzyme introduced well <0.16 ppm and digested 59 FR May 23, 1994 –Marker gene easily digested -FDA suggests that should use kanamycin marker in all GMO –Nutrient level the same –No change in toxic substances- tomatine alkaloid –No need for special labeling Redenbaugh et al Regulatory Issues for the commercialization of tomatoes with an anti-sense polygalacturonase gene In-Vitro Cell Devel Biol 29P: FR may 23, 1994

41 FDA Approvals squash resistant to diseases 1995 potato insect resistant 1996 Soybean - herbicide resistance 1997 corn - corn borer resistance

42 WHO-FAO marker genes not a safety issue (< 1/250,000 of DNA consumed) Report reconfirms prior statement safety aspects of genetically modified food of plant origin

43 First, food safety and labeling-the editorial says let's state once and for all that safety and labeling standards for foods, food ingredients, and feeds should be applied regardless of the techniques used in their production and manufacture. There is widespread Expert consensus about this (in fact, genetic engineering may be safer/more precise than conventional breeding), so why is it even discussed anymore? Foods should continue to be assessed on the basis of substantial equivalence, with labeling required only for (GM) foods that differ significantly in composition or nutritional value from their conventional counterparts. Nature Biotechnology Volume 18 Number 11 p 1119; 2000

44 Substantial Equivalence Principles Term is not in any FDA document Reduction by 10% in key nutrients Increase by 10% in natural non- added background toxicants New proteins well characterized and appear in other foods Source of gene well characterized Need for feeding trials questionable Concern for allergenicity - from typical allergenic food or properties flag as allergen

45 The Legal Dilemma All plants approved have been patented Patents are –New –Novel –Non-obvious –ie Substantially different

46 OECD 2000 UN Organization for Economic Cooperation –Safety of new and novel foods –Safety based on substantial equivalence

47 EPA FIFRA –7 USC 136(a) -136® –Regulates pesticides FQPA 1996 –Pesticide is not a food additive –Stricter evaluation process especially with respect to children exposure

48 EPA principles GMOs are flagged if they are introduced as a pesticide Must submit for approval Under FPA pesticide compounds which include new GMO plant varieties are excluded from Delaney Clause ie they are not considered as additives Use of precautionary principle

49 EPA Precautionary Principles Mission to protect human health and safeguard environment within adequate margin of safety Question of available data vs need to extrapolate Nature of the risk ie if there is a carcinogen risk in introduction use of precautionary assumptions ie projection of risk on the safe side

50 USD - APHIS Fed Plant Pest Act 7 USC regulates introduction of plant pests that cause injury, death or damage to any plant 7 CFR 340

51 GMO: the new potential threat Crossing transgenic species Brazil nut with soybeans for methionine Fish antifreeze protein in ice cream

52 Allergenicity flags Concern for transgenic introduction of allergenic protein to 70 KDa 2. Resistant to digestion 3. Stable to heat processing 4. Similar to amino acid homology in binding sites

53 Social Concepts of Risk Dr. Peter Sandman Risk = Hazard + Outrage

54 Some Definitions Hazard = magnitude x probability –magnitude-how bad it is when something happens –probability-how often it is going to happen When outrage is zero then –Risk = Hazard

55 Hazard is the expected annual mortality and morbidity, and risk assessment measures this.

56 Hazard: Scientific Evidence 1. A laboratory study by Cornell University entomologists indicated that Bt-corn pollen can kill 44% of Monarch butterflies 2. British scientist reports that GM potatoes stunt rats growth and damage their immune system

57 Outrage is everything about a risk that is relevant, EXCEPT how likely it is to hurt you. Outrage usually involves peoples concerns and fears about a risk rather than scientific evidence

58 The Social Concepts of risk Risk = Hazard + Outrage –Fear of the unknown (playing God) –Voluntary vs in-voluntary –Dreaded vs non-dreaded (cancer) The degree of outrage does not necessarily correlate to the degree of hazard r 2 < 4%

59 According to Dr. Sandman: For GM Foods: RISK = HAZARD + OUTRAGE

60 The Social Concepts of risk Risk = Hazard + Outrage for GMO issue –Who gets the risk ? –Trust us –They are just dumb so if we educate them they will accept the technology

61 European Experience UK Ministry of Agr said trust us on BSE Consumer outrage as result of BSE incident ~ 80 dead 1999 Belgiums Dioxin contamination EU concern over lack of data so invoke precaution if dont know enough, dont approve

62 Risk Perception Knowledge does not necessarily lessen consumer concerns.

63 Outrage Outcome Public pays more attention to outrage Activists and media in outrage business Outraged citizens dont listen to hazard data Outrage is a legitimate process When hazard is low - help reduce the outrage - Dont make risk comparisons Dont say they are dumb - all we need to do is educate them

64 Identity Preservation Outrage The Adventis Bt Corn scenario

65 The Transport Industry Farm truck Silo Train car Barge Boat Train car truck

66 GMO analytical Needs Problems in evaluating %GMO –On farm or at commercial silo –Mixing in transport –Cost of test –Time to do –Sample size and reliability

67 Allergen analysis failure Problems extraction denaturation +/- need for specific ELISA not available for most allergens except peanuts and egg (Neogen)

68 Starlink Corn Starlink corn with Cry9C based Bt toxin protein 63FR28258 Bacillus Thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for its Production in Corn; Exemption from the Requirement of a Tolerance May 22, 1998

69 EPA allergenicity evaluation 1. Homology - EPA says no known homology of the 8 amino acid sequence - but not all known 2. Cry9c is resistant to digestion 3. Cry9c is stable to thermal processing 4. MW (68 kD) is in upper range for allergens Thus EPA warned in approval that may be linked to allergens Other EPA arguments to allow approval –Abundance of protein low but patent argues high toxicity –Low environmental exposure but what about corn dust

70 Elisa Test Developed

71 Starlink Corn problem Starlink corn produced by Adventis Corp (Research Triangle NC ) with Cry9c Bt toxin protein Approval given by EPA in 1998 but restricted to animal feed as noted by potential for allergenic response in humans based on four criteria September 2000 Consumer group (FOE) analyzes taco shells and finds Cry9c Bt protein. Sept 11, 2000 calls on EPA to remove Taco Bell begins recall of tacos from supermarkets, as does Safeway product made by Kraft

72 EPA announcement 10/10/00 Adventis CropScience (NC) is financially responsible for the screw-up and must pay for it. Not the farmers fault.

73 Seeds of Dissent The next step : Wednesday, October 11, :48 PM EST WASHINGTON (Reuters) - A biotech corn variety found last month in Taco Bell taco shells and intended only for use as a livestock feed has been detected in a second human food product, a consumer advocacy group said on Wednesday. Genetically Engineered Food Alert, a coalition of health, consumer and environmental groups, said it would announce the product at a news conference on Thursday. ``It'll be a product that people have heard about,'' said Matt Rand, biotechnology specialist for the National Environmental Trust and co-coordinator of the GE Food Alert campaign. The group's announcement last month that Taco Bell taco shells sold in grocery stores contained the Starlink corn variety prompted manufacturer Kraft Foods, a unit of Philip Morris Cos. Inc. (MO.N), to announce a voluntary recall. Starlink corn, which is made by Aventis SA (AVEP.PA), has been approved for animal feed but not for use in human food because of concerns about the potential for allergic reactions. The U.S. Agriculture Department has said it would buy all of the estimated 45 million bushels of Starlink corn produced this year to get it off the market. Aventis will reimburse the department for the expected $90 to $100 million cost of that action.

74 Starlink Corn problem Kelloggs shuts down corn flakes cereal plant ( 10/18/2000) as precaution against potential for allergenic response 10/19/00 Adventis says problem is farmers co-mingled corn into human food destined corn. Of 260 grain elevators, about 106 sent out to food processors which is 12% of Starlink corn or 9 million bushels

75 Problem on the farm NY Times 10/17/00 Fred Rosenberger, who grew 40 acres of StarLink corn in Rineyville, Ky.,this year, was quoted as saying, "We never found out until two weeks ago,"adding that because he stored the corn before realizing that it should be segregated, some 8,000 bushels of StarLink corn were mixed in with about 42,000 bushels of other varieties. Mr. Rosenberger said that some neighbors,whom he declined to name, had unwittingly shipped it to local elevators. Duane Adams, who farms 1,500 acres in Cosmos, Minn., and is vice president of the Minnesota Corn Growers Association, was cited as saying that none of the papers that came with StarLink seed he purchased from Garst last spring carried a warning about the crop's limited use or the notice that it should be planted at least 660 feet from any other corn. "I'm sick of it," Mr. Smith said, vowing to never plant another Aventis product.

76 Millers and Grocers Reuters 10/10/00 Kroger and Albertsons remove cereal and tacos Mission Foods recalls all Tacos (largest US maker) Azteca Milling will take back all yellow 2 corn flour ConAgra stops operations at Kansas corn flour mill - will not disclose customers Nov 3 FDA announces over 300 products with potential risk

77 The Issue Green Party (NZ) health spokeswoman Sue Kedgley was cited as saying on Monday (Oct 30) that Starlink corn was feared to cause allergic reactions and digestion problems in some humans, adding, "Unless the government sets up an immediate program to randomly monitor genetically engineered ingredients in our food supply, it cannot guarantee consumers that their food is safe."

78 Is this a realistic problem ? Ricki Hall Ark. Childrens Hospital Right now sensitivity to the protein is an unknown… FDA/USDA/EPA says little if any risk Les Crawford Georgetown Univ. Its not the human health risk that is concerning. Its that it got there in the first place. Cargill Chair W. Staley says although found in some silos that problem is under control. Will institute new tests. He notes that problem was irresponsible procedures by a few in the chain. There is a process of protocols to be followed, Unfortunately people didnt handle things correctly.

79 Steve Taylor Univ. Nebraska Statement to EPA –Would need repeated long time exposure to Starlink to develop allergy to it –Cry9C accounts for 0.013% of corn grain while most allergens at 1 to 40% in food –this clearly would not produce proteins levels of any health concern

80 websites Northernlight 360 hits in 167 sites Friends of earth Environmental Defense Fund s/cry9c.html The Campaign g.htm Lycos html


82 Bottom Line Many reports since 1990 say there is no problem with GMO Reports include companies and researchers who might gain from process so raise therisk flag But Starlink a different story Iowa Governor says will make Adventis buy back all corn from farmers Feb 2001 Farmers say Adventis not paying up

83 Clinton Action May 3, 2000 Clinton proposes to finalize 1992 policy –Require pre-market 75 day notification process to FDA

84 The New Next to Final Step 66 FR 4706 Jan 18, general_food_safety/gmo/gmo.html Good history of regulation of GMOs Proposed –120 day premarketing notice to FDA

85 Proposed 21 CFR 192 PBN Premarket Biotechnology Notice Identity Function Level Dietary exposure Allergenicity History of use of food in diet FDA response within 120 days

86 The Final Step Labeling - Informed Consent Required warnings –Saccharin –Aspartame –Sulfite –Alcohol –Meat handling –irradiation

87 Labeling - Informed Consent basis the consumers right to know so they can protect themselves from harm Voluntary serious warnings –allergens

88 Labeling - Informed Consent basis the consumers right to know so they can have a freedom of choice Voluntary warnings –Non-GMO

89 FDA Labeling Guidance Document 66 FR 4839 (Jan 18, 2001) Guidance Document – –Labeling is voluntary –Food labeling must be truthful ie no GMO need proof –If GMO significantly different, common and usual name should state so –If allergen present must state so –Example GMO statements

90 European Approach EC - PP is a political tool to be invoked when political interests judge the scientific evidence of safety to be insufficient, inconclusive or uncertain Use PP when need absolute proof of food safety needed Recently 2001 approved GMO for plants but will require labeling

91 Communication on GMO Old style –Science alone provides objective truths - ie the proverbial white paper –Science experts are only possible source of risk evaluation –Consuming public will listen to truths - but they dont

92 Communication on GMO New Paradigm –Right of public to provide input on public policy decisions –Free flow of information (but dont cry fire in the wrong place –Be honest, frank and open –Issue burnout

93 URLs Used in This Slide Show Presentation genfood.htmlwww /onair/worldnewstonight/health/wmt genfood.html safety/gmo/gmo.html

94 Other pertinent material IFT Expert Panel Report on Biotechnology and Foods –

95 Theres a great day dawning if only we can get through the night

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