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Biotechnology, GMOs 2009
What is Biotechnology?
The application of technology to improve
a biological organism.
or
Modification of the biological function of an
organism by adding genes (from another
organism?)
Is biotechnology necessary?
•A rich source of variation already exists in nature.
•But is there all of the diversity we need (want?)
World Food Supply:
We will have to double it by 2050
75% of future growth must come from
lands already in use
Most of the production growth must
occur in countries where it is
consumed, including in marginal
areas where many of the poor reside
Limited potential for land expansions,
except in the Americas and SubSaharan Africa
Irrigation expansion crucial to meeting
food demand
What Happened to
Early
GE Crops and Why
Who’s In Charge (1989-1990)?
• NIH – only agency with policies specific
to biotechnology.
• FDA, USDA, EPA & OSHA competing
for jurisdiction.
• Discovered: no agency w/clear
jurisdiction over transgenic crops.
• With its first submittal in November 1990
for approval of the nptII selectable marker,
Calgene did not want the confidentiality
usually maintained by the FDA. Instead,
the company requested that all findings
and issues be made public.
Result: Interagency group
management of transgenic crops
• USDA given primary responsibility for regulation of
specific research, product development and
commercial applications.
• FDA given principal jurisdiction over products for
human and animal food (CFSAN enforces policy).
• CFSAN – Center for Food Safety and Applied Nutrition.
• Calgene formally requested FDA advisory opinion on
“marker gene” – even before CFSAN had developed
appropriate regulatory path. Petitions to consider it an
“additive.”
• EPA given jurisdiction for products that potentially
contain pesticide residues.
• In May 1991, the FDA published its
findings and called for comments on the
marker gene (note that the first filing was
for the marker, not the whole product, sort
of a "straw man" for things to come). Only
43 public comments were received.
• In August 1991, Calgene submitted a
second filing for the whole tomato.
• In May 1992, the FDA published a policy
on genetically engineered foods and
concluded that the technology did not
make a difference. However, rather than
coming directly from the FDA, this policy
came via Dan Quayle's Council on
Competitiveness, possibly not the most
appropriate medium for such an important
message.
May 1992
FDA states that it will regulate
biotechnology-derived food products in
the same manner as conventional food
products. Will not require special
testing or labeling unless major
modifications (e.g., GRAS) or foreign
genes had been inserted.
(GRAS = Generally Regarded As Safe, i.e. no
detectable significant differences of major
components from a the non-transformed parent.)
Public Reaction
• Jeremy Rifkin (Foundation on Economic
Trends)
• Argues FDA’s standards are too lax
• Primarily concerned with marker gene
• Rifkin actions
• Foundation - lengthy statement to FDA
• “Pure Foods Campaign” – boycott
• “Education materials” to 140,000 teachers
• In January 1993, the advisory opinion was
converted to a food additive petition, which
requires more rigorous scrutiny but leads
to the highest level of formal FDA approval
for this type of product. At that time, an
approval was expected in August 1993.
• In March 1993, Calgene submitted its final
data package, including a toxicity test. The
FDA informed Calgene that its submission
was complete.
• In June 1993, Calgene resubmitted its
environmental assessment. Twenty days
later, the FDA's opinion was published in
the Federal Register, calling for comments
within 30 days. No comments were
received.
• In November 1993, bovine somatotropin
(BST) was approved by the FDA. It is
likely that this approval created a
controversy that would not have existed if
Calgene's tomato was approved first:
tomato growers will sell an estimated $1
billion more tomatoes and thus support the
genetically engineered product, whereas
many milk producers are in fear of BST.
• In February 1994, a Food Advisory
Committee Hearing to approve the tomato
was scheduled. This hearing was called off
and rescheduled. Calgene had to fire a
number of its staff due to the delays.
• Subsequently, the FDA held a 3-day
hearing, and the Center for Food Safety
published their opinion that the tomato
was safe.
• Final approval came May 18, 1994 by fax.
This was the first time that the FDA
approved a whole food made by
biotechnology. This approval reaffirmed
the FDA's May 1992 policy.
Initial Public Concerns about FlavrSavr
• Bacterium used to introduce gene
(possible incorporation of bacterial
genes).
• Randomness of insertion process.
• Side effects?
• Use of kanamycin resistance as marker.
• Allergen?
Calgene Failures with Flavr Savr
• Failure to develop tomato varieties
that could be grown in adequate
quantities in different regions.
• Failure to foresee that existing
equipment (for green tomatoes) could
not handle Flavr Savr© tomatoes.
• Failure to anticipate costs and time of
regulatory process.
Demise of the Flavr Savr
• Consumer Issues
• Consumers did not perceive quality in tomato
• Rising consumer backlash to GMO’s
• Existence of Alternatives
• Israeli varieties (e.g., ‘Long Keeper’)
• Pioneer – ‘Super Life’ (commercial growers)
• DNA Plant Technology – other similar varieties
• Patent infringement suit by Monsanto
• Calgene “sells” technology
Zenaca Seed / Safeway Tomato Paste
Similar to FlvarSavr, additional benefits for Processing, less water, more pulp
• 1994 Campbell Soup, Calgene and Zeneca
settle IP dispute and FDA approves production
• 1995 UK grants food approval
• 1996 Safeway/Sainsbury begin UK sales of California
grown and processed GE tomato paste
• GE paste becomes on of the best selling
in UK market estimated 60% share of canned market
• GE Paste at a 20% cost savings, priced at
29 pence for 170 gms vs 29 pence for 142 grms
• 1999 July, Paste no longer available for sale in UK
Stocks exhausted
•1986 – Federal “Coordinated Framework” for regulating
biotech
•1993 – FDA approves rBGH
•1994 – First biotech food approved (Flavr Savr tomato)
•1996 – First GM corn seed is sold; GM crops enter the
food supply
•1996 – Mad cow disease linked to human brain disease
•1997 – European consumers protest US shipments;
Monsanto targeted
•1999 – Activists get violent; Secretary Glickman is
pummeled in Italy; Monsanto PR campaign backfires in
the EU; Brazil, Australia and China threaten ban;
Monarch butterfly scare
•2000 –Starlink corn crisis
•2001 – Application for GM fish is submitted to FDA; EU
says labeling will be mandatory, trade war lingers;
Mexican maize contamination reported; Monsanto
abandons New Leaf potato
•2002 –Prodigene episode
•2003 – SubSaharan African nations reject US food aid
with GM corn; US sues EU in WTO
•2004 – New EU rules go in effect; Monsanto shelves
GM wheat; Glofish released unregulated
Lessons Learned from Setbacks
• Unforeseen product related problems can occur,
• like shipping and handling attributes, growing
• conditions in various regions present special problems.
• Government policies can change as well as consumer
• preferences and company marketing strategy
• Intellectual property rights are valuable and contestable
•Development to market process is expensive and lengthy
• Scientific success does not guarantee commercial success
•Do what you do best, don’t go where you don’t belong
“What if we’re wrong?”
“There are known knowns; there are the
things we know we know. We also know
there are known unknowns; that is to say
there are some things we do not know.
But there are also unknown unknowns –
the ones we don’t know we don’t know.”
-- Secretary of Defense Donald Rumsfeld, 2002
Papayas
• 1992
devastating outbreak of papaya
ring spot virus in Hawaii
• 40% reduction in production in 5 years
• 1996
Cornell University and University of Hawaii
develop virus resistant “ SunUp and Rainbow “
using coat protein-mediated resistance
• 1998 Hawaiian Papaya Administrative
Papayas
Committee Negotiates with Patent
Holders
To allow GE seeds to be given to Growers,
First Commercial plantings were made
• Over 50% of Hawaii acreage now planted to
GE varieties
• Fortunately efforts to develop a virus-resistant
variety had been underway since 1986
• Timely approval of GE papaya saved the industry
• Papaya not labeled as GE, just Hawaiian, Hawaii 17% of Total US market
of about $55 million mostly from Mexico
The RoundUp Ready Story
• Glyphosate is a broad-spectrum herbicide
• Active ingredient in RoundUp herbicide
• Kills all plants it comes in contact with
• Inhibits a key enzyme (EPSP synthase) in an amino acid pathway
• Plants die because they lack the key amino acids
• A resistant EPSP synthase gene allows crops
to survive spraying
RoundUp Sensitive Plants
Shikimic acid + Phosphoenol pyruvate
+ Glyphosate
Plant
EPSP synthase
X
3-Enolpyruvyl shikimic acid-5-phosphate
(EPSP)
Without amino
acids, plant dies
X
X
Aromatic
amino acids
X
Roundup Resistant Plants
Shikimic acid + Phosphoenol pyruvate
+ Glyphosate
Bacterial
EPSP synthase
RoundUp has no effect;
enzyme is resistant to herbicide
3-enolpyruvyl shikimic acid-5-phosphate
(EPSP)
With amino acids,
plant lives
Aromatic
amino acids
Most Rapid Acceptance of any Agricultural Technology
since the Tractor
Insect resistant cotton – Bt toxin
kills the cotton boll worm
• transgene = Bt protein
Insect resistant corn – Bt toxin kills
the European corn borer
• transgene = Bt protein
Normal
Transgenic
The Golden Rice Story
• Vitamin A deficiency is a major health problem
• Causes blindness
• Influences severity of diarrhea, measles
• >100 million children suffer from the problem
• For many countries, the infrastructure doesn’t exist
to deliver vitamin pills
• Improved vitamin A content in widely consumed crops
an attractive alternative
-Carotene Pathway in Plants
IPP
Geranylgeranyl diphosphate
Phytoene synthase
Phytoene
Problem:
Rice lacks
these enzymes
Phytoene desaturase
ξ-carotene desaturase
Lycopene
Lycopene-beta-cyclase
Normal
Vitamin A
“Deficient”
Rice
 -carotene
(vitamin A precursor)
The Golden Rice Solution
-Carotene Pathway Genes Added
IPP
Geranylgeranyl diphosphate
Daffodil gene
Phytoene synthase
Phytoene
Vitamin A
Pathway
is complete
and functional
Phytoene desaturase
Single bacterial gene;
performs both functions
ξ-carotene desaturase
Lycopene
Daffodil gene
Golden
Rice
Lycopene-beta-cyclase
 -carotene
(vitamin A precursor)
Ordinary tomatoes do not contain genes.
Genetically modified ones do.
True or False ?
False
Don’t
know
True
Canada
52
33
15
USA
45
45
10
Austria
34
22
44
Finland
44
27
29
France
32
39
29
Germany
36
20
44
Ireland
20
51
29
Italy
35
44
21
Netherlands 51
27
22
Spain
28
46
26
Sweden
46
24
30
UK
40
38
22
Survey published in Seed
Trade News, December,
1999. Survey source:
Thomas J. Hoban, North
Carolina State University
The
Percy Schmeiser
Story
Monsanto sued Schmeiser for patent infringement they found their GM canola growing in his field
Schmeiser's original defense:
GM pollen spread and /or GM seeds blew into his
field from neighboring GM canola fields
Later revealed that 95% of his field was GM seed
(320 hectares, 3.2 million square meters)
The
Percy Schmeiser
Story
What probably happened...
•RR-canola found its way into Schmeiser’s
crops in 1997, either by pollen spread or seeds
•Schmeiser discovered presence of RR- canola
in his fields (perhaps by spraying of Roundup
along edges of field)
•Seeds from these plants were saved and
planted in 1998
The
Percy Schmeiser
Story
Then what happened?
•Judgment against, but no monetary
punishment – legal fees?
•15 minutes of fame
•Web page
•Interviews
•Speaking engagements
The
Percy Schmeiser
Story
You Can Help!
If you believe in this important cause,
your assistance towards Percy's legal
bills would be greatly appreciated. You
can make a donation online here, or if
you prefer, you can send a cheque or
money order to:
And the beat goes on……
Genetic Mystery: Contaminated
Rice Seed



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March 8, 2007
There's no genetically engineered rice for sale in the U.S., but tests
of conventional rice seed, starting more than a year ago, have found
traces of three separate genetically engineered strains.
Insiders think the contamination probably occurred at an agricultural
research station near Crowley, Louisiana, (the “rice capital of
America”) operated by Louisiana State University.
Rice pollen doesn't usually travel from one plant to another, but a
windstorm might produce a freak instance of cross-pollination.
However it happened, the genetically modified material did end up in
foundation seed that this research station released to seed
companies.
The Little-Known (Non-GMO) Rice Mutant

Clearfield 131? Well, it's also a herbicidetolerant line of rice. It contains a genetic
mutation that allows it to tolerate doses of
certain chemical herbicides. Scientists
created that genetic change by soaking
rice in mutation-inducing chemicals.
Similar "Clearfield" varieties have been on
the market for years, and nobody outside
the rice industry paid much attention.

March 16 - Mexico Halts US Rice at Border
GMO Seed Sales Halted
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March 13, 2007
The unprecedented ruling follows a
hearing last week in the case brought by
the Center for Food Safety against the
U.S. Department of Agriculture for
approving GE alfalfa without conducting
the required Environmental Impact
Statement

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April 2 - Are GM Crops Behind the Bee
Colony Collapse?
March 26 – “Non-GMO verified”