The Regulation of Genetically Engineered Agricultural Crops

igocheddarBiotechnology

Dec 14, 2012 (4 years and 10 months ago)

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The Regulation of
Genetic Modifications

“The GMO Controversy”

Terminology


Genetically Modified Organisms
(GMOs)


Genetically Modifications


Genetic Engineering


Transgenic Technology


Recombinant DNA Technology (rDNA)


Biotechnology


Bio
-
Engineering


“Frankenfoods”

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
through
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



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 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


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 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 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
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 Sale



soybeans



corn, not blue corn



canola



papaya



potatoes (Russett Burbank)



tomatoes


Approved 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 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 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.


Chymosin


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 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 GM


Bio Pollution


Food Allergens


Patents and Bio piracy


Patenting genetic material taken
without consent


Cloning



Criticisms 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 US


NIH initially responsible for biotechnology
regulation


Established safety protocols for biotech labs


1986
Coordinated Framework for Regulation
of Biotechnology



primary blueprint for the regulation of
biotechnology


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
marketing


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


FDA


January 17, 2001
-

new proposal

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


Food producers must
notify

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
transparency

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

(APHIS)


Oversees field testing of GM seeds and
plants


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
be
“substantially equivalent”

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

Criticism
:


Unexpected substances may
appear in GM foods


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


Safety assessment based on “SE”
not scientifically based

Labeling GM Foods

(The US Position)


Labeling of GM products necessary
only when the product is
materially
different

from its non
-
GM equivalent


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



quality



safety


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
directives

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
Foods


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
-
food
products


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


(Internationally)


January 2000, an
international trade
agreement

for labeling GM foods
established


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


Exporters must be required to label all GM
foods


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

Labeling GM Foods

(Internationally)


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
concept


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
-
legal
tradition regarding good household
management


“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

1.
Preventative anticipation

2.
Safeguarding ecological spaces

3.
Proportionality of response

4.
Duty of Care

5.
Promoting the cause of natural
rights

6.
Paying for past ecological debt

Precautionary Principle


Where scientific information is insufficient,
inconclusive, or uncertain and
where

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
effects

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


Alleged:


Violation of APA


FDA failure to provide EIS


FDA presumption that GM foods are GRAS is
erroneous


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
label

Alliance for Bio
-
Integrity v. Shalala


Court held:


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

material”

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