Pasquali

Environmental Risk Assessment
Symposium
Mexico City, Mexico - March 2nd - 3rd 2011
Problem Formulation in Practice - South America
Environmental Risk Assessment of
Genetically Modified Plants in Brazil
Giancarlo Pasquali
Biotechnology Center
Federal University of “Rio Grande do Sul”
Porto Alegre, RS, Brazil
Brazilian National Legislation on the
Biosafety of Genetically Modified Organisms
Law Nr 11,105
March 24th 2005
“Brazilian Biosafety Law”
Decree Nr 6,925
August 6th 2009
Cartagena Protocol on Biosafety to the
Convention on Biologic Diversity
Decree Nr 5,591
November 22nd 2005
CTNBio
Normative Resolutions
Normative Instructions
CTNBio
Communications
G.Pasquali – CBiot/UFRGS
Brazil´s
President
CNBS composed by Ministers of State:
1. Chief of Staff to the President
2. Science & Technology
Minister and Chief of
Staff to the President
3. Agrarian Development
4. Agriculture, Farming & Supply
5. Justice
6. Health
National Biosafety
Council (CNBS)
7. Environment
8. Development, Industry & Commerce
9. Foreign Affairs
10. Defense
National Biosafety
Technical Commission
(CTNBio)
11. Fisheries & Aquiculture
G.Pasquali – CBiot/UFRGS
Twelve publicly acknowledged specialists in Science & Technology:
3 Specialists in human health
3 Specialists in animal health
3 Specialists in plants
National Biosafety
Technical Commission
(CTNBio)
3 Specialists in environment
One representative of each ministry:
Science & Technology (MCT)
Agrarian Development (MDA)
Agriculture, Farming & Supply (MAPA)
Health (MS)
Environment (MMA)
CTNBio is composed by
54 members =
27 full + 27 substitutes
Development, Industry & Commerce (MDIC)
Foreign Affairs (MRE)
Defense (MD)
Fisheries & Aquiculture (MPA)
One specialist in (indicated by ministry):
Consumer´s rights (M. Justice)
All members must have
Ph.D. degree
Health (MS)
Environment (MMA)
Biotechnology (MAPA)
Family agriculture (MDA)
Worker´s health (M. Labour)
G.Pasquali – CBiot/UFRGS
http://www.ctnbio.gov.br/
CTNBio Normative Resolutions
NR 1 – 06/20/2006 – Biosafety Internal Commissions (CIBio) & Biosafety Quality
Certificate (CQB)
NR 2 – 11/27/2006 – Classification of GMO risks & biosafety levels
NR 3 – 08/16/2007 – Instructions for monitoring commercially released GM maize
NR 4 – 08/16/2007 – Instructions on distances between commercial areas of GM maize
and non-GM maize
NR 5 – 03/12/2008 – Commercial release of GMOs & derivatives
NR 6 – 11/06/2008 – Instructions for the intended release (field testing) of GM plants &
derivatives
NR 7 – 04/27/2009 – Instructions for the intended release (field testing) of GM animals
and microorganisms (& derivatives) of Risk Class 1
NR 8 – 07/03/2009 – Simplified instructions for the intended release (field testing) of
GMOs & derivatives of Risk Class 1
G.Pasquali – CBiot/UFRGS
CTNBio Normative Instructions
NI 02 – 09/10/1996 – GM plant import for research purposes
NI 04 – 12/19/1996 – GMO transport
NI 08 – 07/09/1997 – Genetic manipulation & cloning of human beings
NI 09 – 10/10/1997 – Gene therapy of human beings
NI 13 – 06/01/1998 – GM animal import for research purposes
NI 17 – 11/17/1998 – GMO derivatives: import, commerce, transport, storage,
handling, consumption, release & discharge
NI 18 – 12/15/1998 – Test field and commercial releases of Roundup Ready
soybean
NI 19 – 04/19/2000 – Instructions for public audiences of CTNBio
G.Pasquali – CBiot/UFRGS
CTNBio – Normative Resolution Nr 5
March 12th 2008
“Commercial Release of GMOs and Derivatives”
ANNEX III
EVALUATION OF RISKS TO
HUMAN AND ANIMAL HEALTH
Organisms consumed as food – the focus of this annex is on GMOs or
derivatives that are used as food either for human beings or animals
employed by humans for feeding or housework.
G.Pasquali – CBiot/UFRGS
CTNBio – RN 5 – ANNEX III
EVALUATION OF RISKS TO HUMAN AND ANIMAL HEALTH
1. History of the parental organism use in feeding
2. Effects of the GMO on food chain
3. Chemical and nutritional differences in composition of
derived foods
4. Alterations relative to animal performance when fed with
GMO
5. Recombinant protein stability to digestion and industrial
processing
6. Deleterious effects of the GMO in pregnant animals and
teratogenic potential
G.Pasquali – CBiot/UFRGS
CTNBio – RN 5 – ANNEX III
EVALUATION OF RISKS TO HUMAN AND ANIMAL HEALTH
7. Immunological and histological analyses
tissues, especially of the digestive trait
of
relevant
8. Capacity to produce toxins or metabolites able to cause
adverse effects to the consumer
9. Toxicological
and
pharmacological
experimental animals
evaluations
in
10. Similarity of the recombinant products to known allergens
G.Pasquali – CBiot/UFRGS
CTNBio – Normative Resolution Nr 5
March 12th 2008
“Commercial Release of GMOs and Derivatives”
ANNEX IV
EVALUATION OF ENVIRONMENTAL RISKS – PLANTS
G.Pasquali – CBiot/UFRGS
CTNBio – RN 5 – ANNEX IV
EVALUATION OF ENVIRONMENTAL RISKS – PLANTS
1. Natural area of occurrence of the GM parental organism,
its ancestors and wild relatives
2. History of cultivation and use of the GM parental organism
in terms of safety to the environment and for human and
animal consumption
3. Effects on indicator organisms relevant to ecosystems
4. Ability of the GMO to disperse propagative (spread) or
reproductive structures beyond the areas of cultivation
and the mechanisms of its dispersal
G.Pasquali – CBiot/UFRGS
CTNBio – RN 5 – ANNEX IV
EVALUATION OF ENVIRONMENTAL RISKS – PLANTS
5. Formation of long-living structures of reproduction
6. Frequency of GMO crossing
7. Effects resulting from horizontal transfer to soil microbiota
8. Impacts on target and non-target organisms
9. Alterations in plant ability to add or remove soil
components
G.Pasquali – CBiot/UFRGS
CTNBio – RN 5 – ANNEX IV
EVALUATION OF ENVIRONMENTAL RISKS – PLANTS
10. Alterations in GM plant biodegradability compared to the
parental genotype
11. Resistance to chemical agents conferred by the introduced
characteristic
12. History of GMO commercial use
13. Alterations in the ability to survive in environments distinct
to those occupied by the parental plant
G.Pasquali – CBiot/UFRGS
GMOs Commercially Released in Brazil
Plants
Company
Submission
Decision
T304-40 x GHB119 –
TwinLink Cotton
Bayer S.A.
07/26/2010 02/17/2011
Delay
7 Months
Insect Resistant & Herbicide Tolerant
MON89034 × TC1507 ×
NK603 Maize
Insect Resistant & Herbicide Tolerant
MON88017 Maize
Insect Resistant & Herbicide Tolerant
GHB614 – GlyTol Cotton
Herbicide Tolerant
Bt11 x MIR162 x GA21 Maize
Insect Resistant & Herbicide Tolerant
MON89034 x NK603 Maize
Insect Resistant & Herbicide Tolerant
MON87701 x MON89788
Soybean
Insect Resistant & Herbicide Tolerant
Monsanto do
Brasil Ltda. & Dow
AgroSci. Ind. Ltda.
N.I.
12/16/2010
-----
Monsanto do
Brasil Ltda.
04/20/2010 12/16/2010
8 Months
Bayer S.A.
03/29/2010 12/09/2010
8 Months
Syngenta Seeds
Ltda.
11/18/2010
-----
Monsanto do
Brasil Ltda. & Dow 11/04/2009 11/18/2010
AgroSci. Ind. Ltda.
1 Year
Monsanto do
Brasil Ltda.
N.I.
N.I.
08/19/2010
-----
G.Pasquali – CBiot/UFRGS – March 2011
Plants
Company
Submission
Decision
Delay
A2704-12 - LibertyLink
Soybean
Bayer S.A.
11/01/2007
02/11/2010
2 Years
Bayer S.A
10/31/2008
02/11/2010
2 Years
Embrapa Soja
& BASF S.A.
2009
12/10/2009
-----
Monsanto do
Brasil Ltda.
04/29/2009
10/15/2009
6.5 Months
DuPont do Brasil
S.A. (Pioneer) &
Dow AgroSciences
Industrial Ltda.
N.I.
10/15/2009
-----
Monsanto do
Brasil Ltda.
09/03/2008
10/15/2009
1 Year
Syngenta Seeds
Ltda.
04/29/2009
09/17/2009
5 Months
Herbicide Tolerant
A5547-127 - LibertyLink
Soybean
Herbicide Tolerant
CV127 Soybean
Herbicide Tolerant
MON531 x MON1445
Cotton
Insect Resistant & Herbicide Tolerant
TC1507 x NK603 Maize
Insect Resistant & Herbicide Tolerant
MON89034 Maize
Insect Resistant
Milho Bt11 x GA21 Maize
Insect Resistant & Herbicide Tolerant
G.Pasquali – CBiot/UFRGS – March 2011
Plants
Company
Submission
Decision
Delay
MIR162 Maize
Syngenta Seeds
Ltda.
12/19/2007
09/17/2009
1 Year 9
Months
Monsanto do
Brasil Ltda.
04/29/2009
09/17/2009
5 Months
Monsanto do
Brasil Ltda.
06/28/2007
05/21/2009
2 Years
Monsanto do
Brasil Ltda.
09/29/2006
03/19/2009
2.5 Years
Dow Agrosciences
Industrial Ltda.
12/27/2006
12/11/2008
2 Years
Monsanto do
Brasil Ltda.
10/08/2004
09/18/2008
4 Years
Syngenta Seeds
Ltda.
02/21/2006
09/18/2008
2 Years
Monsanto do
Brasil Ltda.
06/09/2004
09/18/2008
4 Years
Insect Resistant
MON810 x NK603 Maize
Insect Resistant & Herbicide Tolerant
MON15985 - Bollgard
Cotton
Insect Resistant
WideStrike Cotton
Insect Resistant & Herbicide Tolerant
TC1507 Maize
Insect Resistant
MON1445 - Roundup
Ready Cotton
Herbicide Tolerant
GA21 Maize
Herbicide Tolerant
NK603 - Roundup Ready 2
Maize
Herbicide Tolerant
G.Pasquali – CBiot/UFRGS – March 2011
Plants
Company
Submission
Decision
Delay
LLCotton25 - LibertyLink
Cotton
Bayer S.A.
05/24/2004
08/21/2008
4 Years
Syngenta Seeds
Ltda.
07/31/2000
09/20/2007
7 Years
Bayer S.A.
01/06/1999
05/16/2007
8.5 Years
Monsanto do
Brasil Ltda.
10/14/1999
08/16/2007
8 Years
Monsanto do
Brasil Ltda.
06/05/2003
03/17/2005
2 Years
Herbicide Tolerant
Bt11 Maize
Insect Resistant
T25 - LibertyLink Maize
Herbicide Tolerant
MON810 – Guardian
Maize
Insect Resistant
MON531 - Bollgard
Cotton
Insect Resistant
(*) Decision suspended by court until 2003. CTNBio inactive until December 2005.
40-30-2 - Roundup Ready
Soybean
Herbicide Tolerant
Monsanto do
Brasil Ltda.
06/1998
09/29/1998
4 Months*
G.Pasquali – CBiot/UFRGS – March 2011
Vaccines & Yeast
Poulvac ST
Avian Salmonella typhimurium
Vectormune HVT-IBD
Marek & Gumboro avian diseases
Vectormune HVT-NDV
Marek & Newcastle avian diseases
S. cerevisiae Y1979
Industrial production of farnesene
Vectormune FP-MG
Avian fowlpox & Mycoplasma
gallisepticum
Vectormune FP-MG+AE
Avian fowlpox , encephalomyelitis & M.
gallisepticum
Poulvac E. coli
Avian E. coli
Company
Submission
Fort Dodge Saúde
05/17/2010
Animal.
Decision
Delay
11/17/2010
6 Months
Ceva Saúde
Animal Ltda.
02/27/2009
02/11/2010
1 Year
Ceva Saúde
Animal Ltda.
03/09/2009
02/11/2010
1 Year
Amyris Brasil S.A.
10/06/2009
02/11/2010
4 Months
Ceva Saúde
Animal Ltda.
02/27/2009
12/10/2009
10 Months
Ceva Saúde
Animal Ltda.
02/27/2009
12/10/2009
10 Months
Fort Dodge Saúde
Animal Ltda.
02/27/2009
10/15/2009
8 Months
G.Pasquali – CBiot/UFRGS – March 2011
Vaccines
Company
Submission
Decision
Delay
Porcilis Circumvent CVT
Intervet do Brasil
Veterinária Ltda.
03/03/2008
09/18/2008
6 Months
Boehringer
Ingelheim Brasil
Quím. Farm. Ltda.
07/19/2007
06/19/2008
11 Months
Fort Dodge Saúde
Animal Ltda.
05/07/2007
03/13/2008
10 Months
Schering-Plough
06/2002
11/2006
4 Years*
Merial Saúde
Animal Ltda.
12/11/2003
05/12/2004
5 Months
Merial Saúde
Animal Ltda.
02/1998
05/1998
3 Months
Pig Postweaning Multissystemic
Wasting Syndrome
Ingelvac Circoflex
Pig PMWS
Suvaxyn PCV2 One Dose
Pig PMWS
PRV-Marker
Pig viruses
Vaxxitek MD/IBD
Marek & Gumboro avian diseases
Recombitek
Pig viruses
(*) This vaccine was NOT APPROVED by the following score:
17 votes in favor of approval versus 4 votes against.
CNBS changed CTNBio vote weight (power) thereafter.
G.Pasquali – CBiot/UFRGS – March 2011
Brazilian
Native
Vegetation
Brazilian Amazon Forest Vegetation and
Deforestation. The baseline for the Human
Pressure analysis was a dataset that combines
vegetation (IBGE 1997) and deforestation as
of 2001 (INPE 2003).
Areas Planted with Maize in Brazil between 2005 & 2007
Production of
Herbaceous Cotton
Production of
Sugarcane
Problem Formulation &
Environmental Risk Assessment
Native vegetation & alien species
- Are GM crops more alien?
- All GM crops released in Brazil are derived from alien crops.
GM contamination of conventional (traditional) crops
- How different is GM technology from traditional genetics?
- Scientific or cultural problem?
Brazilian “native crops”
- Papaya
- Cocoa tree
- Passion fruit
- Peanut
- Cashew (nut)
- Cassava
- Orchid species
- Palm tree (açaí)
- Pineapple
- Brazilian nut
- Sapucaia nut
-…
G.Pasquali – CBiot/UFRGS
Problem Formulation &
Environmental Risk Assessment
GM plants under analysis for commercial release in Brazil:
- Sugarcane
- Common bean
- Eucalypt
- Rice
- Canola
- Orange
- Papaya
Novel genetic traits under analysis for commercial release:
- drought tolerance
- salt tolerance
- faster growth
- increased sucrose
- increased cellulose
- reduced lignin
- oil composition
- disease (viral, bacterial, fungal) resistance
- fiber quality
- cold tolerance
-…
G.Pasquali – CBiot/UFRGS