Transcript Slide 1

Crop Biotech
Development & Regulation
Bhagirath Choudhary
TERI
09th Feb 2006
• ISAAA: International Service for the Acquisition of Agribiotech Applications (www.isaaa.org)
• It is a not-for-profit internaztional organization cosponsored
by public and private sector institutions
Objectives:
• To facilitates the transfer of crop-biotechnology applications–
particularly private sector proprietary technology– from
industrial to developing countries for their benefit and,
• To share knowledge on crop-biotechnology to various
stakeholders in order to equip them with the latest knowledge
on crop biotech to make informed decisions
ISAAA’s Global Network of Biotechnology Information Centers
www.isaaa.org/kc
Italy
Russia
China
Bulgaria
USA
Egypt
Bangladesh
Mali
Vietnam
India
*Senegal
*Ghana
Thailand
Philippines
KenyaSri Lanka
Malaysia
*Mexico
*Costa Rica
Pakistan
Brazil
*Chile
Argentina
Indonesia
South Africa
Knowledge and Experience Sharing
18 Near-term nodes
*5 Future nodes
Location of the Global Knowledge Center (KC), ISAAA
BIC Objectives & Activities:
• Serve as global knowledge network on crop biotechnology
• Assist national biotech programs in creating an enabling
environment for crop biotech
• Generate, process, and package knowledge on crop biotech
• Facilitate sharing and application of knowledge among
various stakeholders and,
• Develop and validate appropriate science communication
modalities.
• ISAAA Annual Review on Global Status of GM Crops
• ISAAA Publications kit, CDs. etc
• Outreach programs
• Media outreach
• Study tours for farmers, media, scientists, policy makers,
students etc
Global Status of Biotech/GM Crops
Why Global Status?
Assist developing countries in assessing the potential of biotech
crops. The principal aim is to present a set of authenticate,
verifiable and referenced data;
• to facilitate a knowledge based discussion of the current global
trends in biotech crops
• to help stakeholders to take informed decision
Adoption increases continue
after 10 years of commercialization
• Global area reached 90 million hectares, up 11 percent in
2005 as compared to 81 million hectares in 2004
• 8.5 million farmers in 21 countries planted biotech crops as
compared to 8.25 million farmers in 17 countries in 2004
• Herbicide-tolerant soybeans remained the most widely
adopted trait, followed by insect-resistant maize.
• More than fifty-fold increase from 1.7 million hectares in six
countries in ’96
•
In 2005, there were fourteen biotech mega-countries
(countries growing 50,000 hectares -125,000 acres - or more,
of biotech crops), compared with ten in 2003 - 9 developing
countries and 5 industrial countries; they were, in order of
hectarage/acreage, USA, Argentina, Canada, Brazil, China,
Paraguay, India, South Africa, Uruguay, Australia, Romania,
Mexico, Spain and the Philippines.
Expansion and Growth
21 countries planted biotech crops in 2005
14 countries reached “mega-county” status, planting more
than 50,000 hectares.
Global Adoption Rates (%) for Principal Biotech
Crops (Million Hectares)
2005: A Year of Milestones
• In 2005, farmers planted the 1 billionth
cumulative acre, or 400th million
hectare, of biotech crops.
• The first crop of Bt rice was planted in
Iran.
– Most important food crop in world
– Potential to make substantial contribution to
UN Millennium development goal of poverty
reduction by 50% by 2015
Multiple or “Stacked” Traits
• Growing number of varieties with more
than one biotech enhancement
• “Trait hectares” becoming important
growth indicator
• 100 million “trait hectares” planted in
2005
– 10 percent more than adopted biotech crop
area of 90 million hectares
63 Countries & 57 Fruits, Vegetables, Field crops and
other plants-ranging from lab trials to commercial
production
Source: Runge 2004
Sources: ISAAA, IFPRI, Nature, Runge
Sources: ISAAA, IFPRI, Nature, Runge
Sources: ISAAA, IFPRI, Nature, Runge
Global Benefits 1996-2004
• Decrease in pesticide applications: 172,000 metric tons
• Greenhouse gas emissions eliminated by reducing tillage: 10
million metric tons
• Diesel fuel saved by reduced tillage or plowing: 1.8 billion liters
• Increase in net income for farmers: $27billion
• China: Cumulatively since 1997 the farm income benefit has
been $4.16 billion. In 2004, the net national gain to farm income
was $1.1 billion.
• India: At the national level, farm income gains amounted to $6.1
million in 2002, $32.4 million in 2003 and $85.7 million in 2004
(cumulative total of $124.2 million).
• The planting of biotech crops has reduced the “environmental
footprint” of cotton, corn, soy and canola by 14 percent, as
calculated using an established environmental index quotient
(EIQ) that compares the potential impacts of pesticides used in
a conventional field to a field planted with a biotech crop.
• Global value of biotech crop market projected at $5.5 billion in
2006, an increase from $5.25 billion in 2005.
No reports of harm to human or animal safety
Source: Graham Brookes and Peter Barfoot, 2005 (UK) & NCFAP (US)
Impacts of Crop Biotechnology – By Crop Trait
Source: Graham Brookes and Peter Barfoot, 2005 (UK) & NCFAP (US)
India-Fastest Growth
• In 2005, India experienced the highest
yearly percentage growth rate
increasing its area by 160% to 1.3
million hectare of biotech cotton
• Around 10 lakh resource poor farmers
elected to plant Bt cotton in Northern,
Central and Southern cotton growing
zones-three fold increase over 2004
• Grew to seventh largest adopter of
biotech crop
India-Fastest Growth
• 16 new varieties of Bt cotton hybrids
belonging to four companies were released in
2005 totaling to 20 Bt cotton hybrids.
• More than 25 companies are developing
different varieties of biotech cotton hybrids
with different genes and with staked
genes/multiple traits ie. cry1Ac, cryAb, GFMcry1Aa, Vip-3a, cry1Ac+cry2Ab
• UAS, Dharwad along with CICR Nagpur is
developing its own biotech cotton varieties
employing Bt gene and is likely to be
available to farmers in near term
India-Fastest Growth
• In 2005, three companies have received
permission for large scale field trials of biotech
cotton with different genes.
• The approval of more no.s of Bt cotton
hybrids may further grow in 2006. Future
potential for multiple traits in biotech cotton
• Biotech eggplant is under near term
approval. Total 14 field, vegetable and
commercial crops are under advanced stage of
development at various institutions in India
such as rice, mustard, maize, sorghum, tomato,
potato, groundnut, cauliflower, cabbage,
chickpea, okra and pigeonpea etc
India-Fastest Growth
State-wise adoption of Bt cotton
State
2004 (ha) 2005 (ha)
Rank
2004
Rank
2005
Maharastra
200,000
590,000
1
1
Gujarat
130,000
150,000
2
3
Madhya Pradesh
85,000
145,000
3
4
Andhra Pradesh
80,000
280,000
4
2
Karnataka
18,000
30,000
5
6
Tamilnadu
10,000
25,000
6
7
Northern Zone
(Punjab, Hr, Raj)
N/A
60,000
N/A
5
Total
500,000
13,00,000
Developing Countries Benefit
• Resource-poor farmers in developing
countries represent 90 percent of biotech
growers
– Developing nations represent more than onethird of global biotech area.
– Growth in developing countries is four times
(23 percent) as rapid as industrialized countries
(5 percent).
• Biotech crops have increased the income
of 7.7 million farmers in developing
countries, helping alleviate from poverty
European Growth
• Three more European countries grew
biotech crops in 2005, bringing the total
number of EU countries to 5 of 25.
– The Czech Republic planted Bt maize for the
first time.
– France and Portugal resumed planting biotech
maize after a gap of four and five years.
– Germany continued to grow a modest area of
Bt maize.
GM Crops in the European Union
2005 GM crop facts:
• Spain: about 50,000 hectares (12 percent of the
Spanish maize crop)
• France: 500 hectares officially, estimated at up to
1000 hectares
• Portugal: 780 hectares
• Czech Republic: 300 hectares
• Germany: 400 hectares
Source: GMO Compass
GM Crops in the US
• Since 1987, over 11,000 field trials authorized at
50,000 sites; over 100 species of plants and
microorganisms field-tested
• As of December 2005, sixty-six (66) products have
completed U.S. regulatory review
– “Deregulated” products can be used in food,
feed, and in breeding programs in the same way
as their conventional counterparts.
– Commercialization is determined by market
demand.
Products “Deregulated” in US
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•
•
•
•
•
•
•
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Corn - HT, IR, AP
Soybean - HT, PQ
Cotton - HT, IR
Tomato - PQ
Squash – VR
Papaya – VR
Rapeseed - HT, AP, PQ
Chicorium – AP
Tobacco - PQ
*
*
*
*
Potato - IR, VR
Rice - HT
Sugar beet - HT
Flax - HT
*
Not on market
ADOPTION OF GM CROPS IN THE US
Biotech Share (%) of US Corn, Soy, & Cotton
Crops
1999
2000
2001
2002
2003 2004*
Corn
37
25
26
34
40
46
Soybeans
47
54
68
75
81
86
Cotton
48
61
69
71
73
76
* USDA/NASS 2004 forecast at www.usda.gov/nass
US-Regulatory Policy Overview
Coordinated Framework for the regulation of Biotechnology
US Regulatory Authorities for Crop Biotech Products
Agency
Jurisdiction
Laws
USDA
Plant pests, plants, veterinary biology
Federal Plant Pest Act (FPPA)
FDA
Food, feed, food additives, veterinary drugs,
human drugs, medical devices
Federal Food, Drugs & Cosmetic
Act (FFDCA)
EPA
Microbial and plant pesticides, new uses of
existing pesticides, novel microorganisms
Federal Insecticide, Fungicide &
Rodenticide Act (FIFRA), Toxic
Substance Control Act 9TSCA)
• Existing laws were, for the most part, adequate for oversight of
biotechnology products
• The products, not the process, would be regulated
• Genetically engineered organisms are not fundamentally different
from non-modified ones and,
• Oversight authority should be exercised only where there is evidence
that the risk posed by the introduction is unreasonable.
USDA-APHIS: Responsible for ensuring that the growth of genetically
engineered plants does not harm the agricultural environment (as
distinct from the wild environment)
EPA: Responsible for assuring the human and environmental safety
of pesticidal substances engineered into plants, and
FDA: Responsible for assuring that foods derived through genetic
engineering are as safe as their traditional counterparts.
• Integrated U.S. Government Regulatory Website:
• http://usbiotechreg.nbii.gov/
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•
•
•
USDA, FDA and EPA Websites:
www.aphis.usda.gov/brs
www.cfsan.fda.gov/biotechm.html
www.epa.gov/pesticides/biopesticides
UK Regulatory Authority and Advisory Committee
EC DIRECTIVE
90/ 219
NOTIFICATION
EC DIRECTIVE
90/220
APPLICATION
HSE
EC REGULATION
258/97
APPLICATION
FSA
DETR
ACMSF
ACGM
ACRE
ACAF
FAC
ACNFP
ACP
DETR
EC COMMISSION (DGXI)
COMA
COT
FSA
EC COMMISSION (DGIII)
DETR - Department of Environment, Transport and Regions
FSA - Food Standards Agency
HSE - Health and Safety Executive
ACGM - Advisory Committee of Genetic Modification: Advises on all aspects of human and environmental safety of
contained use (e.g., laboratory) of GMOs.
ACRE - Advisory Committee on Releases to the Environment: Considers the environmental safety of field trials and the
marketing of GMOs.
ACAF - Advisory Committee on Animal Feeding stuffs
ACP - Advisory Committee on Pesticides
ACNFP - Advisory Committee on Novel Foods and Processes: Considers the safety of foods derived from GMOs.
ACMSF - Advisory Committee on Microbiological Safety of Food
FAC - Food Advisory Committee
COT - Committee on Toxicity
COMA - Committee on Medical Aspects of Food Policy
US-EU Crop Biotech Regulations
The US and EU differ in the particulars of how they
approach regulation for crop biotech products.
In US and EU, the Current systems are largely
designed to address concerns that can be dealt with
through science
Bottom Line: Ensuring human and environmental
safety
• Economic and socio-cultural-ethical factors
One distinct feature is to allow risk assessment - the
prediction of likely hazard - to drift into risk
management, where economic and socio-culturalethical factors may play a role in deciding whether to
accept a particular level of risk.
Adequate Regulation of Crop Biotech Products
• Comprehensive and rigorous system for ensuring
safety of crop biotech products;
• Process: open, transparent and inclusive
• Information Sharing for public choices and
decisions
• Comprehensive and rigorous system for ensuring
safety of crop biotech products: Mandatory premarket examination by the appropriate regulatory
authorities and approved for sale only after they are
found to meet the standard of presenting a reasonable
certainty of no harm.
- Regulation (Existing/New)
- Biotechnology technique-inherently risky
(Process/Product)
- Risk Assessment (US & EU)
- Substantial Equivalence (genetically engineered
organisms are not fundamentally different from nonmodified ones)
- Assessment of Environmental Impact: likelihood of
outcrossing is very low, or because the spread of
modified traits will not be favoured by natural selection
- Risk-Benefit equations: (US-compared with status
quo, EU-other potential alternatives
- Traceability and Monitoring (US & EU)
- Time Limited Licenses (US & EU)
- Liability and redress (US & EU)
- Co-existence (GM and Non-GM)
- Labeling (Voluntary/Compulsory)
- Precautionary Principle-substantive uncertainties
prevent accurate risk assessment
Process: open, transparent and inclusive
- Risk assessment and risk management, should
include (e.g., toxicologists, nutritionists, molecular
biologists and plant breeders),
- A broad range of specialists and stakeholders (e.g.,
social scientists, ethicists, representatives of civil
society).
Optimistic Outlook
• Future growth expected as secondgeneration input and output traits are
expected in the next decade.
• Anticipated adoption of biotech rice in
China could significantly impact
adoption rates.
• The next 10 years may also bring novel
crop products for more nutritional food
and feed and use as a renewable
resource for biofuel production.
Thanks
International Service for
the Acquisition of Agri-biotech Applications (ISAAA)
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DPS Marg, Pusa, New Delhi-110012, India
Tel: +91-11-39472302
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