Transcript AGRICULTURAL BIOTECHNOLOGY - National Center for Genetic

AGRICULTURAL
BIOTECHNOLOGY
Conflicting Regulatory Paradigms &
A Global Reality Check
Heritage Club
Bangkok, Thailand
28 August, 2003
L. Val Giddings, Ph.D.
Vice President for Food and Agriculture
Biotechnology Industry Organization
Washington, DC USA
The continuing growth of
human population creates or
exacerbates a host of
challenges to the responsible
stewardship of the
environmental health and
biodiversity of planet Earth.
“The greatest challenge of the
st
21 century: feeding 9 billion
people with a sustainable
agricultural production
system.”
--Chrispeels, 2000
To meet these challenges in
the 21st Century and beyond,
humanity will need ever tool it
can find.
What has been the global
experience thus far in terms of
regulatory oversight for the
products of agricultural
biotechnology; and how are
these products scrutinized by
regulatory authorities?
PROBLEM:
Our high degree of technical
understanding has not been translated
into either harmonization or equivalence
among the approval systems in the
major trading nations.
Two Models for Biotechnology Regulation:

An earned trust in the competency and
independence of scientifically based risk
assessments


United States, Australia – New Zealand, Japan
Political reliance on the validity of
current public opinion

European Union
Scientifically, both systems rely on risk
assessment using the same types of
data concerning
the identity
molecular characterization
food safety
environmental impact of new crop varieties.
U.S. – Style System
The recommendations of technical
reviewers are presented to administrative
agencies for acceptance or rejection



U.S. Department of Agriculture
Environmental Protection Agency
Food and Drug Administration
U.S. – Style System

Policy officials are regularly selected for
their familiarity with the subject matter

Applications are made to central
authorities and all evaluations and
interaction with the applicant is
conducted through that agency
E.U. – Style System
The recommendations of technical
reviewers are subject to several layers
of political review by authorities who are
not versed in the scientific or technical
aspects of the application.
E.U. – Style System

There are 6 distinct steps of evaluation
involving agencies in individual member
states, several levels of the European
Commission and the European Council of
Ministers.

Each stage offers an opportunity for
individual member states or the Commission
to delay or prevent action or an application.
Results…
E.U. – Style System

Since October 1998, the EU has not
approved any applications to grow or
import transgenic crops.

13 applications for new products have
been stalled
Results…
U.S. – Style System

Since 1986, the 11 transgenic crops
most commonly field tested have been
planted under more than 6,504 permits
on more than 30,000 test plots.
Results…
U.S. – Style System

USDA found crops pose risks no different
then their conventional counterpart

FDA found crops to be safe for human
consumption

EPA evaluated licensed crops improved to
resist insect pests
This effective and functioning
regulatory regime is the best
explanation for the global
preponderance of biotech crop
land in the U.S.
“Current regulatory scrutiny,
plus the excellent track record
of GM food safety, gives us
confidence that GM foods are
rigorously scrutinized and that
the technology is safe.”
-American Council on Science and Health,
Biotechnology and Food, 2002
Universal Principles for Sound Regulation

Regulatory review must be grounded in
sound science
Universal Principles for Sound Regulation

Regulatory review must be grounded in
sound science

Appropriate standards of risk avoidance
must be applied
Universal Principles for Sound Regulation

Regulatory review must be grounded in
sound science
 Appropriate standards of risk avoidance must
be applied

Regulators must distinguish between
what they need to know vs. what would
be nice to know
What is the ground truth reality of
our experience with crops
improved through biotechnology
to date?
Global Area of Transgenic
Crops, 1996 to 2001
Year
Hectares
(million)
Acres
(million)
1996
1997
1998
1999
2000
2001
1.7
11.0
27.8
39.9
44.2
52.6
4.3
27.5
69.5
98.6
109.2
130.0
Increase of 19%, 8.4 million hectares (20.8 million acres)
between 2000 and 2001.
Source: Clive James, 2001
Global Area of Transgenic
Crops, 1996 to 2001
60
50
40
30
Million Hectares
20
10
0
1996
1997
1998
1999
2000
2001
Source: Clive James, 2001
“A cumulative total of over
175 million hectares
(almost 440 million acres)
of transgenic crops were
planted globally in
16 countries.”
- Clive James, 2001
The majority of the land
devoted to transgenic crops:
United States (68%)
 Argentina (22%)
 Canada (6%)
 China (3%)

Crops improved through
biotechnology that are grown
most frequently:
Soybeans
 Corn
 Cotton
 Canola

Global Area of Transgenic Crops,
1996 to 2000: By Crop
(million hectares)
30
25
20
Soybean
Corn
Cotton
Canola
15
10
5
0
1996
1997
1998
1999
2000
Source: Clive James, 2000
U.S. Biotech Crops
Acres Planted 1996-2002
60
54
50
45.4
1996
40
35
28.3
27
30
20
20
9
10
5.8 7
19
19 .9
# of Acres (Millions)
51.3
9.411.1 10.5 **
0
Cotton
* Planting Estimate based on USDA/NASS report 3/28/02
** Overall cotton plantings decreased but % of acres increased.
*** Corn acreage fluctuates based on presence of European corn borer.
1999
2000
2001
2002*
1
Soybeans
25.3
1997
1998
Corn ***
U.S. Biotech Crops in 2002
% of Acres Planted
74
69
68
70
71
61
60
54
48
47
50
1996
1997
45
37
37
26
40
30
25
20
10
25
% of Total U.S. Acreage
80
2000
2001
2002
13
2
0
Soybeans
32
1998
1999
Cotton
1999 figures are based on a survey of BIO member seed sales.
2000-2001 figures are based on USDA/NASS
2002 figures are estimates of USDA, NASS 3/28/02
* Corn acreage fluctuates based on presence of European corn borer.
Corn *
Improvements most often
delivered through biotechnology
 Herbicide

Enable improved weed control
measures
 Insect

tolerance
resistance
Enable improved pest
management
Global Area of Transgenic Crops,
1996 to 2000: By Trait
(million hectares)
35
30
25
Herbicide tolerance
20
Insect resistance
15
Herbicide tolerance /
Insect resistance
10
5
0
1995
1996
1997
1998
1999
2000
Source: Clive James, 2000
Global Area of Transgenic Crops, 1996 to
2000; Industrial and Developing Countries
(million hectares)
40
35
30
25
Industrial
Developing
20
15
10
5
0
1995
1996
1997
1998
1999
2000
Source: Clive James, 2000
Global Area Adoption Rates (%)
for Principal Transgenic Crops
(million hectares)
160
140
120
100
80
60
40
20
0
Nontransgenic
Transgenic
Soybean
Cotton
Canola
Maize
Source: Clive James, 2000
Most Frequent Categories
Field Releases—PHENOTYPIC CATEGORIES
Herbicide tolerant
6%
15%
30%
4%
Agronomic
properties
Viral resistant
Insect resistant
Fungal resistant
6%
29%
10%
*marker genes, selectable markers, and
bacterial- and nematode resistant phenotypes
Product quality
Other*
MOST FREQUENT CATEGORIES
March1987–June 2002
Source: U.S. Department of Agriculture
Most Frequent Crops
Source: U.S. Department of Agriculture
Summary of
US Experience to date
 9,284
permits + notifications
 38,899 test plots & fields
 ~45 crops approved for wide
scale planting
 0 unexpected, unpleasant
surprises
“Mobilization of these
substantial resources to
address developing world
needs is fundamental to the
future well being of the world,
its natural resources,
and its people.”
-Taylor and Fauquet, 2000
Human Health Impacts

There has not been a single claim of a
negative health impact that has survived
scrutiny

Real potential for eliminating from known
allergens the genes encoding for the proteins
that evoke the allergenic response

Biotechnology produces safer corn harvests
than conventional corn by decreasing risks
posed by carcinogenic mycotoxin
contamination
“It seems perverse, even
criminal, to walk away from an
increased source of food
when we need it desperately.”
-Provessor Derek Burke
Nuffield Council on Bioethics
Crops and foods improved
through biotechnology are
subjected to more extensive
and detailed prior scrutiny
than any others in history.
“The American Society for Cell Biology
vigorously supports research and
development in the area of genetically
engineered organisms, including the
development of genetically modified crop
plants…New products from genetically
modified crops promise significant
improvement in human health and the
environment.”
American Society for Cell Biology,
Statement in Support of Research on
Genetically Modified Organisms
“Instead of rejecting the solutions offered by
science, we should change policies to
assure that the solutions benefit the
poor…Condemning biotechnology for its
potential risks without considering the
alternative risks of prolonging the human
misery caused by hunger, malnutrition and
child death is unwise and unethical.”
- Per. Pinstrup-Anderson
Director General, International
Food Policy Research Institute
Environmental Impacts
The fundamental threat to
biodiversity comes from the
destruction of native habitat
“The primary cause of the decay
of organic diversity is not direct
human exploitation or
malevolence, but the habitat
destruction that inevitably results
from the expansion of human
populations and human activities.”
- Paul Ehrlich, 1988
“It is this broad-scale clearing
and degradation of forest habitats
that is far and away the main
cause of species extinctions.”
- Norman Myers, 1988
Biotechnology promises to
reduce threats to biodiversity
by:

Improving crop production on existing
lands
 Decreasing the environmental impacts of
agricultural practices
 Reducing the pressure to convert more of
the remaining wilderness to agriculture
“The traditional and supposedly
‘sustainable’ methods of farming
many consumers think they
should encourage are often
terribly wasteful of nature and
natural resources.”
-Stephen Budiansky
Washington Post
April 15, 2001
Economic Impact
With crops improved through
biotechnology, the key commodity is
information, and this is carried in the
seed itself. Further, its delivery is
scale neutral and not capital
intensive for the farmer.
Through the 8 crop varieties
widely planted in the U.S. to date,
biotechnology has:
Increased yields by 4 billion pounds
 Saved growers $1.2 billion annually
 Reduced pesticide use by 46 million
pounds annually

-Leonard Gianessi
National Center for Food and Agricultural Policy
If an additional 32 crop
varieties were adopted:
Crop yields would increase by an
estimated 10 billion pounds
 Costs to growers would be reduced by
an additional $400 million annually
 Further reduce pesticides by 117 million
pounds

-Leonard Gianessi
National Center for Food and Agricultural Policy
“Nearly three quarters (71%) of
U.S. population said they would
be likely to buy produce that had
been enhanced through
biotechnology to be protected
from insect damage and require
fewer pesticide applications.”
-International Food Information Council
U.S. Consumer Attitudes Toward Food Biotechnology,
August 2002
“The membership of the Society
for In Vitro Biology believes that
the commercialization of
genetically engineered crops will
have a dramatic and positive
impact on people the world over.”
-Society for In Vitro Biology
Position Statement on Crop Genetic Engineering (2000)
Sample of Scientific Community in
Favor of Biotechnology
American Council on Science and Health
American Dietetic Association
American Institute of Biological Science
American Medical Assoc. Council on Scientific
Affairs
American Psychopathological Society
American Society of Agronomy
American Society for Cell Biology
American Society for Horticulture science
American Society for Microbiology
American Society of Plant Biologists
American Society of Plant Physiologists
Brazilian Academy of Sciences
Chinese Academy of Sciences
Committee on Science Subcommittee on Basis
Research, U.S. House of Representatives
Council for Agricultural Science and Technology
Crop Science Society of America
Entomological Society of America
Federation of Animal Scientific Societies
Food and Agriculture Organization
Genetics Society of America
Indian National Science Academy
Institute of Food Science and Technology
Institute of Food Technologists
International Society of African Scientists
Mexican Academy of Sciences
National Academy of Science and Technology of
the
Republic of the Philippines
National Academy of Sciences of the USA
New Zealand Royal Commission
Society of Nematologists
Pontifical Academy of Sciences
The Royal Society of London
Third World Academy of Sciences
Weed Society of America
Agricultural Biotechnology Regulation
There has been a long-standing
agreement among scientists and
regulators on the best way to carry out
risk assessment for crops and foods
improved through biotechnology.
Conclusion

Crops and foods improved through
biotechnology are subjected to more
extensive and detailed prior scrutiny
than any others in history
Conclusion

Crops and foods improved through biotechnology are
subjected to more extensive and detailed scrutiny
than any others in history

Crops and foods are at least as safe as,
if not safer than their conventional
counterparts
Conclusion

Crops and foods improved through biotechnology are
subjected to more extensive and detailed scrutiny
than any others in history

Crops and foods are at least as safe as, if not safer
than their conventional counterparts

Substantial benefits accrue to those
who grow them, the environment, and
those who eat them
Conclusion

Crops and foods improved through biotechnology are
subjected to more extensive and detailed scrutiny
than any others in history

Crops and foods are at least as safe as, if not safer
than their conventional counterparts

Substantial benefits accrue to those who grow them,
the environment, and those who eat them

Significant potential to improve our
stewardship of the planet, and the lives
of people in industrial and developing
nations alike
“Genetic modification can reduce the
chemical load in the environment, reduce
the impact on non-target species, and
reduce the amount of land required for
food crops. There are so many real
benefits from genetic modification
compared to the largely hypothetical and
contrived risks that it would be foolish to
ban genetic modification.”
-Patrick Moore, Ph.D.
Ecologist; Greenpeace Co-Founder
Additional Resources

www.bio.org
 www.ncfap.org (data on economic and
agricultural impacts of crops improved
through biotech)
 www.isaaa.org (data on global acreage &
adoption rates; FAQs on ag biotech)
 www.icsu.org (summary of global scientific
consensus)