The Regulation of Genetic Modifications “The GMO Controversy”

The Regulation of The Regulation of Genetic ModificationsGenetic Modifications

““The GMO Controversy”The GMO Controversy”

TerminologyTerminology

Genetically Modified Organisms Genetically Modified Organisms (GMOs)(GMOs)

Genetically Modifications Genetically Modifications Genetic EngineeringGenetic Engineering Transgenic Technology Transgenic Technology Recombinant DNA Technology (rDNA)Recombinant DNA Technology (rDNA) BiotechnologyBiotechnology Bio-EngineeringBio-Engineering ““Frankenfoods”Frankenfoods”

An Example:An Example:

BT CornBT Corn– Species of corn containing transplanted Species of corn containing transplanted

gene from B. Thuringiensisgene from B. Thuringiensis– Resulted in 20% decline in sales of Resulted in 20% decline in sales of

insecticides in areainsecticides in area– 1999 Cornell University study said Bt 1999 Cornell University study said Bt

corn kills Monarch butterflycorn kills Monarch butterfly– Doomsday CornkillerDoomsday Cornkiller

Caterpillar resistant to insecticidesCaterpillar resistant to insecticides

The Science of GMOsThe Science of GMOs

Random genetic variation occurs naturally Random genetic variation occurs naturally in all living things in all living things

Is the basis of evolution of new species Is the basis of evolution of new species through through natural selectionnatural selection

Selective breeding of wild plants, animals Selective breeding of wild plants, animals and microorganisms such as yogurt and microorganisms such as yogurt cultures and yeasts, cultures and yeasts, to produce to produce domesticated variants better suited to the domesticated variants better suited to the needs of humans.needs of humans.

The Science of GMOsThe Science of GMOs

The most recent application of biotechnology The most recent application of biotechnology to food is to food is genetic modificationgenetic modification

Term “GMOs” used in regulatory documents Term “GMOs” used in regulatory documents and in the scientific literature to describeand in the scientific literature to describe– plants, animals and microorganisms which have plants, animals and microorganisms which have

had DNA introduced into them by means other had DNA introduced into them by means other than by combination of an egg and a sperm or by than by combination of an egg and a sperm or by natural bacterial conjugation.natural bacterial conjugation.

The Science of GMO’sThe Science of GMO’s

Selective breeding methods are based on Selective breeding methods are based on the transfer of genetic material between the transfer of genetic material between individuals of the same speciesindividuals of the same species

Today, gene technology makes it possible Today, gene technology makes it possible to move genes between different speciesto move genes between different species

Geneticist “speed up” natural selection Geneticist “speed up” natural selection and transfer beneficial characteristics from and transfer beneficial characteristics from one species to anotherone species to another..– Resistance, grow speed, grow conditions, Resistance, grow speed, grow conditions,

climate tolerance, yield, etc.climate tolerance, yield, etc.

The History of GMO’sThe History of GMO’s

1971 Paul Berg inserted DNA from cancer tumor into E-coli strain

Opponents (Jeremy Rifkin) feared release of human cancer agent that would replicate in human organs and cause “public disaster”

Berg suspended his experiments after public outcry and Rifkin’s use of judicial process (Injunction)

The History Law of GMOsThe History Law of GMOs

Sparked series of scientific conferences resulting in “Berg letter” which declared moratorium on rDNA research until adequate controls were developed

Recombinant DNA Advisory Committee (RAC) formed to compose guidelines for rDNA research.

Guidelines only applied to Government funded labs.

Legislative ActionLegislative Action

Senator’s Ted Kennedy and Jacob Javits (1976)

Proposed separate Bills to place rDNA research under control of Department of Health

Result was inaction by Congress (couldn’t make the call)

Judical ActionJudical Action

Ananda Charkarbarty (GE Microbiologist) filed application for a patent on pseudomonas bacteria that was believe to degrade crude oil spills

Bacteria did not previously exist in nature. Created by cell fusion

PTO rejected application on basis of Patent Act section 101 that bacteria were “living things are not the proper subject of a patent under US law”

Diamond v. Chakarbarty

Genetic ModificationsGenetic Modifications

13 countries produced GM crops in 200013 countries produced GM crops in 2000 68% of all GM crops grown by US 68% of all GM crops grown by US 82% of all GM crops are soybeans82% of all GM crops are soybeans

– Cotton nextCotton next 74% of all soybean crops were modified 74% of all soybean crops were modified

for herbicide tolerancefor herbicide tolerance GM crop production increased from 4.3 GM crop production increased from 4.3

million acres in 1996 to 109 million acres million acres in 1996 to 109 million acres in 2000in 2000

Genetic ModificationsGenetic Modifications

Maize with 2 herbicide tolerance 23 varieties may tested w/o strict

regulation FAO says food output must increase 60%

over next 25 years to meet projected demand

UCS says GM could improve food yields by 25%

GMO Crops Approved for SaleGMO Crops Approved for Sale

soybeans corn, not blue corn canola papaya potatoes (Russett Burbank) tomatoes

Approved GMO ProductsApproved GMO Products

Yellow crook-neck squash red-hearted chicory (radicchio) cotton dairy products from cows injected

with the genetically altered hormone recombinant bovine growth hormone

(rBGH)

Impacts of Genetic ModificationImpacts of Genetic Modification

1.4 billion farmers in developed countries depend on “saved seeds” and seed exchanges (50% of crops)

1998 Monsanto sued 100 US soybean growers and hired “Pinkerton” agents to track down “seed savers”

“Pineland Seed Company” was granted patent in 1998 for “terminator technology”– seeds do not germinate if planted for second

time

Impacts of Genetic ModificationImpacts of Genetic Modification

WR Grace patent on extracts from “Neem” tree destroyed southern Indian farmers market– Locals could no longer not grow Neem

w/o license from Grace 1995 attempt by 2 Doctors to patent

“tumeric” as healing powder opposed by India b/c discovery not original. In traditional Indian texts

Other ImpactsOther Impacts

1997 “Ricetec, Inc.” granted patent for crossing Indian basmati rice with semi-dwarf varities. Patent covered Basmati rice grown “anywhere” in Western Hemisphere. Patent gave Ricetec exclusive right to market any blend of the 22 farmer-bred varieties of Pakistan or Indian basmati rice with Ricetec’s other seeds and right to use Basmati names.

Indian Government challenged Ricetec’s claim which threatened 277 million dollar Indian rice market and Punjabi farmers.

ChymosinChymosin

First approved use of recombinant DNA-developed food ingredient. (March 1990)

Milk clotting enzyme used to make cheese and other dairy products (Rennet)

Chymosin was GRAS affirmation petition

Chymosin ApprovalChymosin Approval

Chymosin gene encoded a protein with same function and structure as animal derived Chymosin

Manufacturing process removed most impurities

Production organisms destroyed or removed during production and are non-toxigenic, and non pathogenic

Antibiotic-resistance markers are destroyed in the manufacturing process

Manufacturer had to prove:

Criticisms of GMCriticisms of GM

Bio Pollution Food Allergens Patents and Bio piracy Patenting genetic material taken

without consent Cloning

Criticisms of GMCriticisms of GM

Species crossing diseases Ethics and Eugenics Monopolization of world food supply

by multinationals protected by patents

Loss of biodiversity Power over reproductive process Human engineering

GMO Regulation in the USGMO Regulation in the US

NIH initially responsible for biotechnology NIH initially responsible for biotechnology regulationregulation– Established safety protocols for biotech labsEstablished safety protocols for biotech labs

1986 1986 Coordinated Framework for Regulation Coordinated Framework for Regulation of Biotechnologyof Biotechnology – primary blueprint for the regulation of primary blueprint for the regulation of

biotechnologybiotechnology– Redistributed responsibility for biotechnology Redistributed responsibility for biotechnology

regulation to FDA, USDA and the EPAregulation to FDA, USDA and the EPA 1992 Statement of Scope 1992 Statement of Scope

– Speed up and simplify the process of bringing Speed up and simplify the process of bringing products, developed through biotech to products, developed through biotech to consumers, food processors and farmersconsumers, food processors and farmers


FDA Responsibility:FDA Responsibility:– oversees the safety of all foods and oversees the safety of all foods and

animal feeds for consumption, including animal feeds for consumption, including both GM and non-GM productsboth GM and non-GM products

– producers of new foods have an producers of new foods have an obligation under the HACCP to ensure obligation under the HACCP to ensure that the foods they offer consumers are that the foods they offer consumers are safe and in compliance with applicable safe and in compliance with applicable legal requirementslegal requirements

– Voluntary consultation with FDA prior to Voluntary consultation with FDA prior to marketingmarketing


Scientific evidence shows that Scientific evidence shows that bioengineered food ingredients are not bioengineered food ingredients are not materially different from the non-materially different from the non-engineered versionsengineered versions

1992 Statement of Policy: Foods Derived 1992 Statement of Policy: Foods Derived from New Plant Varieties, said GM from New Plant Varieties, said GM products are GRASproducts are GRAS

Courts have concluded that the FDA's Courts have concluded that the FDA's decision to accord bioengineered food a decision to accord bioengineered food a presumption of GRAS statuspresumption of GRAS status was neither was neither arbitrary nor capriciousarbitrary nor capricious


FDA FDA – January 17, 2001- January 17, 2001- new proposalnew proposal to expand the to expand the

FDA's regulatory control by making FDA's regulatory control by making pre-market pre-market consultation mandatoryconsultation mandatory

– Food producers must Food producers must notifynotify the FDA at least the FDA at least 120 days in advance of their intent to market 120 days in advance of their intent to market GM productGM product

– Must show that the GM product is as Must show that the GM product is as safe as its safe as its conventional counterpartconventional counterpart and no potential and no potential safety, labeling or adulteration issuessafety, labeling or adulteration issues

– increase the increase the transparencytransparency of the FDA's safety of the FDA's safety review process for GM foodsreview process for GM foods


USDA Responsibility:USDA Responsibility:– conducted primarily under the Federal conducted primarily under the Federal

Plant Pest Act and Plant Pest Act and Animal and Plant Animal and Plant Health Inspection ServiceHealth Inspection Service (APHIS) (APHIS)

– Oversees field testing of GM seeds and Oversees field testing of GM seeds and plantsplants

– Places inspectors in biotechnology plantsPlaces inspectors in biotechnology plants– Current USDA Secretary is “pro GMO”Current USDA Secretary is “pro GMO”

Ann VenemanAnn Veneman


EPA Responsibility:EPA Responsibility:– Authority over GMOs comes from Authority over GMOs comes from

Federal Insecticide, Fungicide and Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Rodenticide Act (FIFRA)

– Evaluates the pesticide properties of Evaluates the pesticide properties of transgenic plantstransgenic plantsVirus resistanceVirus resistance Insect protectionInsect protectionherbicide toleranceherbicide tolerance

Substantial EquivalenceSubstantial Equivalence

A GM food will be considered to A GM food will be considered to be be “substantially equivalent”“substantially equivalent” to to the natural product if after a the natural product if after a comparison of several different comparison of several different characteristics, no difference is characteristics, no difference is shown.shown.

CriticismCriticism::

Unexpected substances may Unexpected substances may appear in GM foodsappear in GM foods

GM foods approved on the basis of GM foods approved on the basis of substantial equivalence are not substantial equivalence are not safe because not tested rigorously safe because not tested rigorously enoughenough

Safety assessment based on “SE” Safety assessment based on “SE” not scientifically basednot scientifically based

Labeling GM FoodsLabeling GM Foods (The US Position)(The US Position)

Labeling of GM products necessary Labeling of GM products necessary only when the product is only when the product is materially materially differentdifferent from its non-GM equivalent from its non-GM equivalent– e.g. whether the use of biotechnology e.g. whether the use of biotechnology

has changed the:has changed the: qualityquality safety safety nutritional compositionnutritional composition

EU Consumers:EU Consumers: Prefer traditional food practicesPrefer traditional food practices

– safer and closer to nature safer and closer to nature Culture and tradition affect private Culture and tradition affect private

attitudes toward regulation of foodsattitudes toward regulation of foods Have their source in the customs of the Have their source in the customs of the

Middle AgesMiddle Ages Legacy of genetic testing on humans Legacy of genetic testing on humans

during the Nazi eraduring the Nazi era European resistance to GM products is a European resistance to GM products is a

function of the public's distrust of the function of the public's distrust of the ability of their regulators to prevent such ability of their regulators to prevent such episodes as the mad cow disease crisisepisodes as the mad cow disease crisis

GMO Regulation InternationallyGMO Regulation Internationally

1957 Treaty of Rome established EU1957 Treaty of Rome established EU– Silent on food safetySilent on food safety

No central European Food Safety No central European Food Safety Authority similar to the FDA or USDAAuthority similar to the FDA or USDA

Member States continue to possess Member States continue to possess discretion in their agri-food policiesdiscretion in their agri-food policies

EU has issued several important GMO EU has issued several important GMO directivesdirectives

GMO Regulation InternationallyGMO Regulation Internationally

Directives 90/119 and 90/220 of 1990 Directives 90/119 and 90/220 of 1990 – regulates theregulates the unintentional and deliberate unintentional and deliberate

release of GM crops into the environmentrelease of GM crops into the environment 1997 Council Regulation 258/97 on Novel 1997 Council Regulation 258/97 on Novel

FoodsFoods– novel foods and novel food ingredients are novel foods and novel food ingredients are

subject to a single safety assessment before subject to a single safety assessment before they are placed on the marketthey are placed on the market

Directive 1813/97Directive 1813/97– compulsory labeling of GM soya beans and compulsory labeling of GM soya beans and

maize marketed in the EUmaize marketed in the EU

GMO Labeling InternationallyGMO Labeling Internationally

EU has developed a complex codex of EU has developed a complex codex of labeling regulations directly addressing labeling regulations directly addressing GMOs as a GMOs as a separate category of agri-food separate category of agri-food productsproducts

Regulation 258/97 created additional labeling Regulation 258/97 created additional labeling requirements for food products which have requirements for food products which have been found to be been found to be "no longer equivalent" to "no longer equivalent" to their traditional counterparts, as determined their traditional counterparts, as determined by scientific assessment”by scientific assessment”

Labeling GM FoodsLabeling GM Foods (Internationally)(Internationally)

January 2000, an January 2000, an international trade international trade agreementagreement for labeling GM foods for labeling GM foods establishedestablished

130 countries, including the US, the 130 countries, including the US, the world's largest producer of GM foods, world's largest producer of GM foods, signed signed

Exporters must be required to label all GM Exporters must be required to label all GM foods foods

Importing countries have the right to judge Importing countries have the right to judge for themselves the potential risks and for themselves the potential risks and reject GM foods, if they so choosereject GM foods, if they so choose

Labeling GM FoodsLabeling GM Foods (Internationally)(Internationally)

Mandatory labeling of novel food products Mandatory labeling of novel food products containing more than one percent containing more than one percent engineered DNA or protein contentengineered DNA or protein content

Mandatory pre-market testingMandatory pre-market testing Refinement of the substantial equivalence Refinement of the substantial equivalence

conceptconcept Development and implementation of GMO Development and implementation of GMO

tracing technologytracing technology Creation of a content-based mandatory Creation of a content-based mandatory

labeling requirements for products derived labeling requirements for products derived from GMOfrom GMO

Precautionary PrinciplePrecautionary Principle

Evolved out of German socio-legal Evolved out of German socio-legal tradition regarding good household tradition regarding good household managementmanagement

““Vorsorgeprinzip” = foresight principleVorsorgeprinzip” = foresight principle Constructive partnership between Constructive partnership between

individual, economy, and government to individual, economy, and government to manage change so as to improve the lot manage change so as to improve the lot of both society and the natural worldof both society and the natural world

Six Basic ConceptsSix Basic Concepts

1.1. Preventative anticipationPreventative anticipation

2.2. Safeguarding ecological spaces Safeguarding ecological spaces

3.3. Proportionality of responseProportionality of response

4.4. Duty of CareDuty of Care

5.5. Promoting the cause of natural Promoting the cause of natural rightsrights

6.6. Paying for past ecological debtPaying for past ecological debt

Precautionary PrinciplePrecautionary Principle

Where scientific information is insufficient, Where scientific information is insufficient, inconclusive, or uncertain and inconclusive, or uncertain and wherewhere there are indications that the possible there are indications that the possible effects of the environment, or human, effects of the environment, or human, animal or plant health may be potentially animal or plant health may be potentially dangerous and inconsistent with the dangerous and inconsistent with the chosen level of protection," chosen level of protection," action may be action may be taken in order to prevent such negative taken in order to prevent such negative effectseffects

Precautionary PrinciplePrecautionary Principle::

Feb 2000 - Commission produced the Feb 2000 - Commission produced the "Communication from the Commission on the "Communication from the Commission on the Precautionary Principle”Precautionary Principle”– outline the Commission's approach to using the outline the Commission's approach to using the

precautionary principle;precautionary principle;– establish Commission guidelines for applying it; establish Commission guidelines for applying it; – build a common understanding of how to assess, build a common understanding of how to assess,

appraise, manage and communicate risks that appraise, manage and communicate risks that science is not yet able to evaluate fully; science is not yet able to evaluate fully;

– avoid unwarranted recourse to the precautionary avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism.principle, as a disguised form of protectionism.

GMO SummaryGMO Summary

GMO GenerallyGMO Generally– Definitions (magic words)Definitions (magic words)

Safety Assessment Protocols:Safety Assessment Protocols:– Substantial Equivalence Substantial Equivalence – Precautionary PrinciplePrecautionary Principle

Regulation of GMOs in US:Regulation of GMOs in US:– Substantial Equivalence (SE)Substantial Equivalence (SE)– Voluntary ConsultationVoluntary Consultation– Presumption of GRAS statusPresumption of GRAS status– No labeling required if SENo labeling required if SE

Regulation of GMOs internationallyRegulation of GMOs internationally– By EU DirectiveBy EU Directive

Recent CaseRecent Case

Alliance for Bio-Integrity v. Shalala 9/2000Alliance for Bio-Integrity v. Shalala 9/2000 Consumer group challenged FDA lack of Consumer group challenged FDA lack of

mandatory labeling for GM foodsmandatory labeling for GM foods Alleged:Alleged:

– Violation of APAViolation of APA– FDA failure to provide EISFDA failure to provide EIS– FDA presumption that GM foods are GRAS is FDA presumption that GM foods are GRAS is

erroneouserroneous– GM foods w/o labeling are misbranded because GM foods w/o labeling are misbranded because

fail to reveal “material factsfail to reveal “material facts””

Alliance for Bio-Integrity v. ShalalaAlliance for Bio-Integrity v. Shalala

Court held:Court held:– 1992 Policy Statement was a policy 1992 Policy Statement was a policy

statement and not a substantive rule so statement and not a substantive rule so APA did not applyAPA did not apply

– FDA presumption of GRAS status not FDA presumption of GRAS status not arbitrary or capricious because based on arbitrary or capricious because based on substantial evidencesubstantial evidence

– Court will not interfere with FDA Court will not interfere with FDA decisions regarding what information is decisions regarding what information is “material” enough to be included on “material” enough to be included on labellabel

Alliance for Bio-Integrity v. ShalalaAlliance for Bio-Integrity v. Shalala

Court held:Court held:– Consumer interest alone is insufficient Consumer interest alone is insufficient

to deem the use of GM technology as to deem the use of GM technology as ““material”material” for purposes of labeling for purposes of labeling

– Without a determination that GM foods Without a determination that GM foods pose inherent risks or safety pose inherent risks or safety consequences to consumers or differ in consequences to consumers or differ in some way from their counterparts, FDA some way from their counterparts, FDA is without authority to mandate labelingis without authority to mandate labeling

Documents

The Regulation of Genetic Modifications “The GMO Controversy”