The Regulation of Genetically Engineered Agricultural Crops


14 déc. 2012 (il y a 9 années et 2 mois)

434 vue(s)

The Regulation of
Genetic Modifications

“The GMO Controversy”


Genetically Modified Organisms

Genetically Modifications

Genetic Engineering

Transgenic Technology

Recombinant DNA Technology (rDNA)




An Example:

BT Corn

Species of corn containing transplanted
gene from B. Thuringiensis

Resulted in 20% decline in sales of
insecticides in area

1999 Cornell University study said Bt
corn kills Monarch butterfly

Doomsday Cornkiller

Caterpillar resistant to insecticides

The Science of GMOs

Random genetic variation occurs naturally
in all living things

Is the basis of evolution of new species
natural selection

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

The Science of GMOs

The most recent application of biotechnology
to food is
genetic modification

Term “GMOs” used in regulatory documents
and in the scientific literature to describe

plants, animals and microorganisms which have
had DNA introduced into them by means other
than by combination of an egg and a sperm or by
natural bacterial conjugation.

The Science of GMO’s

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

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

Geneticist “speed up” natural selection
and transfer beneficial characteristics from
one species to another

Resistance, grow speed, grow conditions,
climate tolerance, yield, etc.

The History of GMO’s

Paul Berg

inserted DNA from cancer
tumor into E
coli strain

(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 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 Action

Ted Kennedy

Jacob Javits


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

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

Judical 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
things are not the proper subject of a
patent under US law”

Diamond v. Chakarbarty

Genetic Modifications

13 countries produced GM crops in 2000

68% of all GM crops grown by US

82% of all GM crops are soybeans

Cotton next

74% of all soybean crops were modified
for herbicide tolerance

GM crop production increased from 4.3
million acres in 1996 to 109 million acres
in 2000

Genetic Modifications

Maize with 2 herbicide tolerance

23 varieties may tested w/o strict

FAO says food output must increase 60%
over next 25 years to meet projected

UCS says GM could improve food yields by

GMO Crops Approved for Sale


corn, not blue corn



potatoes (Russett Burbank)


Approved GMO Products

Yellow crook
neck squash

hearted chicory (radicchio)


dairy products from cows injected
with the genetically altered hormone

recombinant bovine growth hormone

Impacts 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

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

Impacts 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 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.


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

Milk clotting enzyme used to make
cheese and other dairy products


was GRAS affirmation

Chymosin Approval

Chymosin gene encoded a protein with
same function and structure

as animal
derived Chymosin

Manufacturing process removed most

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

resistance markers are
destroyed in the manufacturing process

Manufacturer had to prove

Criticisms of GM

Bio Pollution

Food Allergens

Patents and Bio piracy

Patenting genetic material taken
without consent


Criticisms of GM

Species crossing diseases

Ethics and Eugenics

Monopolization of world food supply
by multinationals protected by

Loss of biodiversity

Power over reproductive process

Human engineering

GMO Regulation in the US

NIH initially responsible for biotechnology

Established safety protocols for biotech labs

Coordinated Framework for Regulation
of Biotechnology

primary blueprint for the regulation of

Redistributed responsibility for biotechnology
regulation to FDA, USDA and the EPA

1992 Statement of Scope

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

GMO Regulation in the US

FDA Responsibility:

oversees the safety of all foods and
animal feeds for consumption, including
both GM and non
GM products

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

Voluntary consultation with FDA prior to

GMO Regulation in the US

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

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

Courts have concluded that the FDA's
decision to accord bioengineered food a
presumption of GRAS status

was neither
arbitrary nor capricious

GMO Regulation in the US


January 17, 2001

new proposal

to expand the
FDA's regulatory control by making
consultation mandatory

Food producers must

the FDA at least
120 days in advance of their intent to market
GM product

Must show that the GM product is as
safe as its
conventional counterpart

and no potential
safety, labeling or adulteration issues

increase the

of the FDA's safety
review process for GM foods

GMO Regulation in the US

USDA Responsibility:

conducted primarily under the Federal
Plant Pest Act and
Animal and Plant
Health Inspection Service


Oversees field testing of GM seeds and

Places inspectors in biotechnology plants

Current USDA Secretary is “pro GMO”

Ann Veneman

GMO Regulation in the US

EPA Responsibility:

Authority over GMOs comes from
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA)

Evaluates the pesticide properties of
transgenic plants

Virus resistance

Insect protection

herbicide tolerance

Substantial Equivalence

A GM food will be considered to
“substantially equivalent”

the natural product if after a
comparison of several different
characteristics, no difference is


Unexpected substances may
appear in GM foods

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

Safety assessment based on “SE”
not scientifically based

Labeling GM Foods

(The US Position)

Labeling of GM products necessary
only when the product is

from its non
GM equivalent

e.g. whether the use of biotechnology
has changed the:



nutritional composition

EU Consumers:

Prefer traditional food practices

safer and closer to nature

Culture and tradition affect private
attitudes toward regulation of foods

Have their source in the customs of the
Middle Ages

Legacy of genetic testing on humans
during the Nazi era

European resistance to GM products is a
function of the public's distrust of the
ability of their regulators to prevent such
episodes as the mad cow disease crisis

GMO Regulation Internationally

1957 Treaty of Rome established EU

Silent on food safety

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

Member States continue to possess
discretion in their agri
food policies

EU has issued several important

GMO Regulation Internationally

Directives 90/119 and 90/220 of 1990

regulates the

unintentional and deliberate
release of GM crops into the environment

1997 Council Regulation 258/97 on Novel

novel foods and novel food ingredients are
subject to a single safety assessment before
they are placed on the market

Directive 1813/97

compulsory labeling of GM soya beans and
maize marketed in the EU

GMO Labeling Internationally

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

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

Labeling GM Foods


January 2000, an
international trade

for labeling GM foods

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

Exporters must be required to label all GM

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

Labeling GM Foods


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

Mandatory pre
market testing

Refinement of the substantial equivalence

Development and implementation of GMO
tracing technology

Creation of a content
based mandatory
labeling requirements for products derived
from GMO

Precautionary Principle

Evolved out of German socio
tradition regarding good household

“Vorsorgeprinzip” = foresight principle

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

Six Basic Concepts

Preventative anticipation

Safeguarding ecological spaces

Proportionality of response

Duty of Care

Promoting the cause of natural

Paying for past ecological debt

Precautionary Principle

Where scientific information is insufficient,
inconclusive, or uncertain and

there are indications that the possible
effects of the environment, or human,
animal or plant health may be potentially
dangerous and inconsistent with the
chosen level of protection,"
action may be
taken in order to prevent such negative

Precautionary Principle

Feb 2000

Commission produced the
"Communication from the Commission on
the Precautionary Principle”

outline the Commission's approach to using the
precautionary principle;

establish Commission guidelines for applying it;

build a common understanding of how to assess,
appraise, manage and communicate risks that
science is not yet able to evaluate fully;

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

GMO Summary

GMO Generally

Definitions (magic words)

Safety Assessment Protocols:

Substantial Equivalence

Precautionary Principle

Regulation of GMOs in US:

Substantial Equivalence (SE)

Voluntary Consultation

Presumption of GRAS status

No labeling required if SE

Regulation of GMOs internationally

By EU Directive

Recent Case

Alliance for Bio
Integrity v. Shalala 9/2000

Consumer group challenged FDA lack of
mandatory labeling for GM foods


Violation of APA

FDA failure to provide EIS

FDA presumption that GM foods are GRAS is

GM foods w/o labeling are misbranded because
fail to reveal “material facts

Alliance for Bio
Integrity v. Shalala

Court held:

1992 Policy Statement was a policy
statement and not a substantive rule so
APA did not apply

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

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

Alliance for Bio
Integrity v. Shalala

Court held:

Consumer interest alone is insufficient
to deem the use of GM technology as


for purposes of labeling

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