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Title: GMO*%20and%20Food%20Safety

GMO and Food Safety
Dr. Ted Labuza Department of Food Science and
Nutrition Univ. Of Minnesota St Paul
55108 tplabuza_at_umn.eduhttp//
Frankenfoods ???
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Safety issues over GMO
  • Classic toxicity testing
  • Substantial equivalence
  • Pre-cautionary principal vs risk benefit
  • Identity preservation
  • labeling

Poisonous or Deleterious Substances
  • general toxicity
  • carcinogens
  • mutagens
  • teratogens

FDA Regulation of GMOs
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

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

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,
  • radio-nucleotides, pesticides

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

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
What level of toxicant is tolerable, if
any? What level of toxicant is detectable ?
Food Additives Amendment 1958
  • 402(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
  • Note that added means intentional addition so
    would apply to GMO unless exempt as additive or

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

Additive testing history
  • Based on traditional toxicity testing
  • FDA Red Book - 1982 1st edition
  • LD50 acute toxicity
  • Sub-acute toxicity
  • Life time chronic feeding trials
  • Safety based on 100th of the level of NOAEL
  • Also applied to GRAS substances

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

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

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

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

  • 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.1
    1958 through either scientific procedures or
    common use in food to be safe under the
    conditions of its intended use.

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

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
  • Fmali sues to lift ban
  • Court agrees that GRAS means anywhere in world
    not just US thus if used can bring in
  • 53 FR 16544 5/10/88 - substantial use as an
    ingredient for food by a significant number of

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

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

Classical Breeding History
  • Discussion at Hort. Science meeting
  • published in 1975 Spiher A.T. The Growing of
    GRAS Hort Sci. 10241-42 1975
  • Approval based on nutrient level and
    toxicological levels

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?

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

The FDA Policy
  • 57 FR 22983-23005 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

The FDA Policy
  • 57 FR 22983-23005 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 2561747 1992
  • Current working policy - 45 products have been
  • 12 corn, 7 canola, 6 tomato, 5 cotton, 4 potato
  • see IFT Expert Report on Biotechnology

Basis of policy
  • 402 (a)(1) of FFDC
  • see Ronk et al Hort Sci 251482-84 1990
  • Animal feeding studies problematic
  • Animal tests not sensitive as cannot supplement
    at high enough level
  • Need multidisciplinary assessment process based
  • 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 605 1995 pgs 12-22
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 15415 April 1, 1994

OSTP 1994
  • Coordinated Framework for US Biotechnology Policy
  • 51 FR 23302 June 26, 1986
  • Exercise of Federal oversight
  • 57 FR 6753 Feb 24 1992
  • Use risk based scientific approach rather than
    process used (ie dont focus on biotech process
    rather use the standard safety evaluation

The Genetic Raw Potato
  • Ewan and Pusztai Lancet 3541353-4 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

Early Genetic Engineering of GRAS Ingredients in
  • The first round chymosin
  • recombinant technology
  • Inserted gene for calf rennet into E. coli
  • gt80 of world cheese making

Early Genetic Engineering of GRAS Ingredients in
  • The first round chymosin
  • Deemed to be GRAS
  • 57 FR 10932-6 23/3/90 E coli
  • 57 FR 6476-91992 yeast
  • 58 FR 27197-203 1993 mold
  • See Flamm E.L. Bio/Technology 9340-351 1991
  • Same protein structure
  • Most impurities removed
  • Organism destroyed in processing
  • Anti-biotic resistant marker destroyed

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

The first controversy - Monsanto Milk -
Recombinant BST or rBGH Neither GRAS nor Food
Additive rather It is an approved New Animal Drug
Flavor-Savr Tomato
  • Calgene asks for food additive status for enzyme
    FDA Docket 90A-0416, 91A-0330
  • FDA findings
  • enzyme introduced well documented _at_ lt0.16 ppm and
    digested 59 FR 26700-711 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 29P17-26 1993
  • 59 FR 26700-711 may 23, 1994

FDA Approvals
  • 1994 - squash resistant to diseases
  • 1995 potato insect resistant
  • 1996 Soybean - herbicide resistance
  • 1997 corn - corn borer resistance

  • 1993 - marker genes not a safety issue (lt
    1/250,000 of DNA consumed) Report 93.6
  • 2000 - reconfirms prior statement safety aspects
    of genetically modified food of plant origin

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
Substantial Equivalence Principles
  • Term is not in any FDA document
  • Reduction by 10 in key nutrients
  • Increase by 10 in natural non-added background
  • 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

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

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

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

EPA principles
  • GMOs are flagged if they are introduced as a
  • 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

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

  • Fed Plant Pest Act 7 USC 150 - regulates
    introduction of plant pests that cause injury,
    death or damage to any plant 7 CFR 340

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

Allergenicity flags
Concern for transgenic introduction of allergenic
protein 1. 10 to 70 KDa 2. Resistant to
digestion 3. Stable to heat processing 4. Similar
to amino acid homology in binding sites
Social Concepts of Risk Dr. Peter Sandman
  • Risk Hazard Outrage

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

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

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
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 r2 lt 4

According to Dr. Sandman
  • For GM Foods

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

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

Risk Perception
  • Knowledge does not necessarily lessen consumer

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

Identity Preservation Outrage
  • The Adventis Bt Corn scenario

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

Identity Preservation
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

Allergen analysis failure
Problems extraction denaturation /- need for
specific ELISA not available for most
allergens except peanuts and egg (Neogen)
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
EPA allergenicity evaluation http//www.environmen
  • 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
  • Other EPA arguments to allow approval
  • Abundance of protein low but patent argues high
  • Low environmental exposure but what about corn

Elisa Test Developed
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
  • as does Safeway product made by Kraft

EPA announcement 10/10/00
Adventis CropScience (NC) is financially
responsible for the screw-up and must pay for it.
Not the farmers fault.
Seeds of Dissent
  • The next step Wednesday,
    October 11, 2000 448 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

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

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.
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
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
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

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

  • Northernlight 360 hits in 167 sites
  • Friends of earth http//
  • Environmental Defense Fund http//www.environmenta
  • The Campaign http//
  • Lycos http//

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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

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

The New Next to Final Step
  • 66 FR 4706 Jan 18, 2001
  • http//
  • Good history of regulation of GMOs
  • Proposed
  • 120 day premarketing notice to FDA

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

The Final StepLabeling - Informed Consent
  • Required warnings
  • Saccharin
  • Aspartame
  • Sulfite
  • Alcohol
  • Meat handling
  • irradiation

Labeling - Informed Consentbasis the consumers
right to know so they can protect themselves from
  • Voluntary serious warnings
  • allergens

Labeling - Informed Consentbasis the consumers
right to know so they can have a freedom of choice
  • Voluntary warnings
  • Non-GMO

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

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
  • Use PP when need absolute proof of food safety
  • Recently 2001 approved GMO for plants but will
    require labeling

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

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

URLs Used in This Slide Show Presentation.
  • www.204202.137.114/onair/worldnewstonight/health/w
  • http//

Other pertinent material
  • IFT Expert Panel Report on Biotechnology and
  • http//

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