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Risk Assessment of GM Crops in ASEAN
Citation preview
10/8/2010
1
Risk Assessment of Genetically
Modified Food and Feed in
Southeast Asia
Flerida A. Cariño, Ph. D.
Professor, UP Diliman
Physical Scientist, DOST BC
References• BCH website: http://bch.cbd.int/
• Country website on biosafety (if available, and if in English)
• CERA GM Crop database (formerly hosted by Agbios): http://cera-gmc.org/index.php?action=gm_crop_database
• Codex Alimentarius:– Principles for the Risk Analysis Of Foods Derived From Modern
Biotechnology (CAC/GL 44-2003)
– Guideline for the Conduct of Food Safety Assessment Of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003)
• Conversations with country regulators and other resource persons
• General references
Brunei Darussalam
ASEAN B i o t e c h n o l o g y P u b l i c a t i o n S e r i e s No.2
GMO in Brunei
From FAQ paper produced by ASEAN
Q: Are GMOs used in Brunei Darussalam? Are they on the
shelf in supermarket in Brunei Darussalam?
A: No.
Q: Is Brunei going to allow GMOs to be used in future?
A: Subject to meeting ethical and social considerations, it
may be possible to use some GMOs and products derived
from GMOs in the future.
GMO in Brunei
From FAQ paper produced by ASEANQ: How would Brunei go about drafting regulations?
A: The regulations may be modeled after existing international
regulations with appropriate modifications or alterations based on the
ethical and religious requirement of the country.
Q: What are the major issues that need to be addressed in the
regulations?
A: possible risks and benefits ; public response about the quality and
safety of the products; safety and marketing of GMOs and products
derived from GMO; label giving details of risks and benefits associated
with the products; label if gene comes from humans or from animals
subject to religious dietary restrictions or cause any special ethical
concerns.
Cambodia
Draft
10/8/2010
2
Risk Assessment
• Subject to risk assessment prior to approval to entry into the environment of Cambodia
• LMOs imported for contained use.
• LMOs imported for intentional introduction into the environment.
• LMOs imported for direct use as food or feed or for processing.
� Approval comes from Min. of Environment, with technical advice from Nat’l Biodiversity Steering Committee.
Cambodian Biosafety Law
• Will not regulate:• LMOs pharmaceuticals for human use already
addressed by relevant international agreements and/or organization;
• LMOs in transit through but not destined for use in Kingdom of Cambodia;
• Any other categories of living modified organisms that may be exempted by the Competent National Authority; and
• Any processed products containing dead modified organisms or non- living components of genetically modified organisms.
Risk Assessment
• RA instrument still being crafted
• No entries in BCH nor national biosafety
website
Indonesia:
From BCH website:
• Competent National Authorities: – Department of Agriculture
– Food and Drug Agency
– Ministry of Environment
– Ministry of marine and Fisheries Affairs
• National Database or Website: Indonesian Institute of Sciences
– contains info on national regulation on Genetically Engineered Product, related regulations, decision on GEP, risk assessment summaries and roster of experts.
Food and Drug Agency (FDA)
• LMOs for direct use as feed
• LMOs for direct use as food
• LMOs for processing
– Any application for LMOs for use as food or feed or for processing submitted to the Indonesian FDA cc to National Biosafety Commitee
– addresses all types of organisms
– Scope: Food Safety, Quality, and Nutrition
– Entered into force 2004-07-12
10/8/2010
3
Ch.1, General provisions
Par 18. “Food derived from genetically modified
product shall mean food produced or using
any raw materials, food additives and/or any
other materials that are produced from
genetically modified process.”
Chapter II: Food Safety
7 parts:
Part One: Sanitation
Part Two: Food Additives
Part Three: Genetically Modified Food Product
Part Four: Food Irradiation
Part Five: Food packaging
Part Six: Food Quality Assurance and Laboratory Testing
Part Seven: Contaminated Food
Part Three
Genetically Modified Food Product
Article 14
(1) Any person who produces food or uses raw
materials, food additives and/or any other
processing aid in the activity or process of
producing food obtained from genetically
modified process shall have the safety of such
food examined prior to distribution.
Part Three
Genetically Modified Food Product
Article 14
(2) The examination of the safety of such genetically modified food as contemplated in paragraph (1) shall include:a. its genetic information, among others the general
description of the genetically modified food product, the host description and its use as food;
b. its donor organism description;
c. its genetic modification description;
d. its genetic modification characterization; and
e. its information on the safety of the food, among others, its substantial equivalence, nutrition value alteration, allergenicity and toxicity.
Of special interest…
• Article 37 (Food Importation and Exportation), Item (3):
(3) In setting forth the requirements as contemplated in paragraphs (1) and (2), the Ministers or the Head of the Agency shall comply with the TBT/SPS WTO agreement or any agreements that have been ratified by the Government.
From items (1) and (2) of Art. 37: covers fresh and processed food
RA of GM foods
• Essentially follows Codex guidelines
• Science-based assessments• Concept of substantial equivalence used:
– Nutrient content of the GMO substantially equivalent with non-GMO counterpart (carbohydrate, lipid, protein, ash, minerals, amino acid, fatty acids).
– Content of toxicant, antinutrient and allergen (if any) has to be substantially equivalent with those in the non-GMO counterpart.
10/8/2010
4
RA of GM foods
• Uses both weight of evidence approach
(toxicity, comparisons of nutrients and
anti-nutrients) and decision trees
(allergenicity) in RA
• Mandatory labeling if 5% threshold
exceeded
Labeling
• Mandatory labeling if 5% threshold exceeded
– For consumer information and consumer rights
– no relation between GMO labeling with the safety
of the GMO in the packaged food
Stacked traits
• No direct articulation of RA used fro stacked traits
• High probability of interaction of stacked traits may trigger further RA and even generation of more data (case-to-case), but paper evaluation may suffice*
*interview with Dr. Herman
Output
Output
• Pre-Protocol Decisions:
1. Risk Assessment of Bt-Cotton (limited environmental
release 2001, 2002 and 2003) – 17 May 1999
• Bollgard™ cotton (MON531-6 /757/1076): nptII from E.
coli (KanR); cry1A(c) from B. thuringiensis (R to
lepidopteran pests)
• Overall risk : Transgenic cottons are safe for environment
and biodiversity; and exhibit the same characteristics as
nontransgenic cotton.
• Recommendation: Transgenic cottons are safe for
agriculture.
Output
• Pre-Protocol Decisions:
– Others: Declared "safe towards environment
and biodiversity" by Biosafety Commitee
• Transgenic RR cotton -1999
• Transgenic RR soybean -1999
• Transgenic RR corn (GA21) -1999
• Transgenic Bt corn (MON 810) -1999
• Ronozyme-P (probiotic food)- 2001
• Finase-P, Finase-L (probiotic food)- 2001
10/8/2010
5
LMO for which simplified procedure was applied
Bollgard™ Cotton
Roundup Ready™ Cotton
• Bollgard cotton (Colombia)
• RR cotton (Colombia, S.
Africa)
• Bollgard II cotton (S. Africa)
• YieldGard Maize (810-6, S.
Africa)
• YieldGard maize (Bt 11, S.
Africa)
• RR Maize (S. Africa)
• RR soybean (S. Africa)
• RR cotton (Mon 014445, S.
Africa)
• RR YieldGard maize (MON
603 x MON810, S. Africa)
• RR Flex cotton (MON88913-
8, S. Africa) x MON 1445-2)
• RR Bollgard cotton
(MON531-6)
�not likely to have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human health?
�Implications for stacked trait RA?
Quick recall: FDA
• Objective: to protect the people from food
that may impair and/or risk for their health
• Scope: Food Safety, Quality, and Nutrition
• Entered into force 2004-07-12
� All decisions made before FDA document put
in place.
Lao PDR Risk assessment
General Principles
1. Risk Assessment carried out in scientifically sound and transparent manner, can take into account expert advice of, and guidelines developed by, relevant international organizations.
2. Lack of scientific knowledge or scientific consensus not necessarily interpreted as indicating particular level of risk, absence of risk, or acceptable risk
Risk assessment
General Principles3. Risks associated with living modified organisms
or products thereof …should be considered in context of risks posed by non-modified recipients or parental organisms in the likely potential receiving environment.
4. Risk assessment carried out on case-by-case basis, required information may vary in nature and level of detail from case to case, depending on LMO concerned, its intended use and likely potential receiving environment.
Risk assessment
The Government of Lao PDR will establish
technical guidelines on risk assessment and
management:
“1. Biosafety Guidelines in Biotechnology and
Genetic Engineering for Laboratory work
2. Biosafety Guidelines in Biotechnology and Genetic
Engineering for field work and planned release.
3. Biosafety Guidelines on Risk Assessment and
Management to Living Modified food. “
10/8/2010
6
Capacity building needs
5.3. Risk assessment and other scientific and technical
expertise 1. Access to reference materials / databases on risk assessment
2. Competence to review and audit risk assessments
3. Establishment of risk assessment review mechanisms, including
consideration of risk assessment review bodies (e.g., independent
scientific advisory committees).
4. National biosafety research
5. National risk assessment frameworks, principles, procedures and
mechanisms
6. Risk assessment methodologies
7. Risk assessment scientific expertise
Malaysia
Malaysia
• Malaysian Biosafety Act of 2007
• Features:
– An Interministerial National Biosafety Board fro
decision makin
– GMAC to give science-based advice
– Based on precautionary approach: if there are
threats of irreversible damage, lack of full
scientific evidence may not be used as reason not
to take action to prevent such damage
Malaysia
• Features:
– Socioeconomic considerations may be taken
into account on a case-by case basis
• Existing social/economic patterns
• Livelihood
• Social, cultural, ethical religious considerations
– Allows CBI
– Mandatory labeling
Risk Assessement
• Deduced from contents of Malaysian Biosafety
website (http://www.biosafety.nre.gov.my/approved.shtml)
• 4 Approved events for FFP (all singles)
– Roundup Ready™ GTS 40-3-2 Soybean
– MON 810 YieldGard™ Maize
– NK603 Roundup Ready™ Maize
– MON 863 YieldGard® Rootworm++ Maize
LMO for which simplified procedure was applied
Bollgard™ Cotton
Roundup Ready™ Cotton
• Bollgard cotton (Colombia)
• RR cotton (Colombia, S.
Africa)
• Bollgard II cotton (S. Africa)
• YieldGard Maize (810-6, S.
Africa)
• YieldGard maize (Bt 11, S.
Africa)
• RR Maize (S. Africa)
• RR soybean (S. Africa)
• RR cotton (Mon 014445, S.
Africa)
• RR YieldGard maize (MON
603 x MON810, S. Africa)
• RR Flex cotton (MON88913-
8, S. Africa) x MON 1445-2)
• RR Bollgard cotton
(MON531-6)
�not likely to have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human health?
�Implications for stacked trait RA?
10/8/2010
7
Safety assessment records:
“The nutritional equivalence and wholesomeness of GTS 40-3-2 soybean compared to conventional soybeans was demonstrated by the analysis of key nutrients, including proximates, amino acid and fatty acid composition, as well as anti-nutrients. The nutritional equivalence of GTS 40-3-2 soybean to conventional soybean was confirmed in numerous feeding studies with rats, cows, pigs, broiler chickens, fish and quail. The environmental impact of Roundup Ready™ GTS 40-3-2 soybean is also comparable to conventional soybeans. Study results show that Roundup Ready™ GTS 40-3-2 soybean are as safe as conventional soybeans with respect to food, feed and environmental safety. “
Safety assessment records:
“Safety assessments and proximate analysis carried out on the nutritional composition of MON810 grain indicated that there was no variation between the transgenic line and the conventional counterpart. Test results indicate that there is a low potential for toxicity and allergenicity of the Cry1Ab protein. In simulated gastric fluids, the protein rapidly degraded and when administered to laboratory mice , did not display any acute toxicity, showing that consumption of the protein by humans and animals did not have any negative consequences. “
Safety assessment records:
“NK603 was compared to its conventional
counterpart by analysing key nutrients and
substantial equivalence was found. This was
confirmed by evaluation of the feed
performance in broiler chickens and a rat
feeding study.“
Safety assessment records:
“Nutritional and anti-nutritional factors in
MON863 were examined and found to be
within the normal range of unmodified maize
varieties. Various simulated feeding studies
indicate that the Cry3Bb1 protein does not
have potential for being an allergen or toxin as
it is rapidly digested and inactivated by
heating.“
Risk assessment
• Apparently followed Codex
• Apparently used the concept of substantial
equivalence
• Also used the weight of evidence approach
• No data nor articulated policy on stacked
events
Myanmar
Draft prepared under
UNEP-GEF Biosafety
Project
10/8/2010
8
Features
• Calls for a risk assessment of GMOs for FFP,
but no risk assessment system articulated in
Draft Biosafety Framework.
• NO BCH record of country decisions and
communications
Singapore
GM Food safety
• Assessed under Singapore Guidelines on the Release of Agriculture-related Genetically Modified Organisms (GMOs)
• GMAC is approving body
• Risk assessment criteria for food indicated by questions in Appendix 1: Questionnaire for Risk Assessment of Genetically Modified Organisms (GMOs) Related to Agriculture , Sect. K: Organisms to be consumed as food
GM food safety
• Apparently comparative
• Considers host, donor, toxicity, allergenicity,
molecular data, gene product, consumption
pattern, but document does not specify data
required for toxicity and allergenicity
• Most probably uses Codex guidelines
GM food safety
• No entries in country decisions and
communications
• No written policy/risk assessment instrument
for stacked events
Thailand
•No entries for :
•Competent National Authorities, National Biosafety Websites and
Databases, National Laws, Regulations, Guidelines and Bilateral,
Regional and Multilateral Agreements, Country decisions on LMOs
under AIA, FFP, RA reports
10/8/2010
9
Thailand
No English Translation
Thailand
No English Translation
Thailand
No English Translation
Thailand
• Based on references, a few words and
footnotes written in English, RA seems to
follow Codex Alimentarius Guidelines:
– Principles for the Risk Analysis Of Foods Derived
From Modern Biotechnology (CAC/GL 44-2003)
– Guideline for the Conduct of Food Safety
Assessment Of Foods Derived from Recombinant-
DNA Plants (CAC/GL 45-2003)
Food safety assessment system in place, BUT:
Cabinet’s decision on April 3, 2001: No to importation and production of any transgenic plants for commercial purposes and field trials except for:
(1) processed food; and(2) imports or sales of soybeans and corn for feed use, human consumption, and industrial use.
Furthermore, all trials conducted for research purposes must be contained in laboratories or greenhouses. In 2007, field trials in Government experimental stations allowed.
Thailand
Sathin Kunawasen 2010
Thai Stacks Regulation
• developed among technical experts in BIOTEC as guide for evaluation of stacked traits.
• internally developed; stakeholders submitted comments; consultation meetings with industry
• Technical Biosafety Committee (TBC) reviewing stacked traits guidelines
� unofficial translation document presented here
10/8/2010
10
Thai Stacks Safety Assessment
• 2 cases:Case 1: GM hybrids obtained from conventional
breeding technology of GM parents that contain approved genes. (Approval from DA for environmental release and FDA for food use, and/or the Department of Livestock Development for feed use)
Case 2: GM hybrids obtained from conventional breeding technology where one or both parental lines have not been approved for commercialization or safety assessment for food use, feed use and environment.
Overview of RA for stacked traits
• Target genes, new proteins and gene interactions
or proteins expression in stack products taken
into account (possibility of change in
environmental impact or increase in toxicity,
allergenicity and adverse nutritional effects.
• Requires food safety assessment , environmental
safety assessment, other assessments (e.g.,
socio-economic impact, trading impact etc.)
before environmental release or consumption.
Case 1.
GM hybrids from conventional breeding of GM
parents that contain approved genes
Approvals:
-DA: environmental release
-FDA: food safety approval
- Dep’t of Livestock Development: feed safety
Case 1. Data requirements:
1. Molecular characterization: to investigate insertion site, gene arrangement and copy number including gene expression; gene stability of hybrids and DNA sequencing observed to see possible abnormality that may occur after conventional breeding.
�Southern blot analysis to compare hybrids and parents; expected to show gene size, gene structure, copy number, insertion site and gene stability. (main requirement.)
�Northern blot analysis, DNA sequencing and PCR required. In some case, information of flanking DNA and open reading frame (ORF) used to confirm that ORF will not produce toxins or allergens.
Case 1. Data requirements
2. Gene expression
– compare hybrid’s expression with parents (must be
at same level and profile as those of parents); plant
samples taken at appropriate time for
testing(e.g.,utilized part at harvest stage)
– Evaluation criteria considered on case-by-case basis
depending on type of gene and protein products.
– Protein analysis carried out to observe expression
levels at various growth stages in different type of
tissues.
Case 1. Data requirements
2. Gene expression data:
a. Western blot analysis to observe protein expression and protein sizes.
b. ELISA or mRNA analysis to observe expression levels in different tissues at various growth stages.
c. Enzyme assay technique to observe protein function in specific plant organs.
d. Metabolite analysis technique to observe changes in metabolic pathway; used when protein is related to enzymes or metabolic pathway abnormality caused by new gene introduction or interaction between parents’ genes.
10/8/2010
11
Case 1. Data requirements
3. Phenotypic expression and hybrid abnormality - to
compare morphology and other characteristics of
hybrids to GM parents and non-GM counterparts.
– Data required from at least 4 different growing
locations to see whether different environments
affect gene expression levels.
Case 1. Data requirements
4. Protein and new substance safety – to compare
nutrient compositions and nutrient levels of hybrids
with parents and with non-GM counterparts.
– If interactions indicated, additional data required:
a. Molecular weight of proteins
b. Amino acid sequences
c. Immuno- reaction
d. Post translational modifications
e. Role of proteins that may be similar to other proteins
Case 1. Data requirements
4. Protein and new substance safety data
4.1 Protein digestibility in simulated gastrointestinal tract.
4.2 Toxicology data obtained from animal feeding study (OECD
14-day rat feeding study)
4.3 Changes in composition or other types of protein.
4.4 Possibility of proteins to be allergens
Case 1. Data requirements
5. Toxicology in regards to human and animal consumption (use
of proper laboratory animals)
6. Allergenicity
6.1 History of safe use of proteins
6.2 Sequence similarity to known allergens (8 consecutive amino acid
identity criterion)
6.3 Heat stability
6.4 Protein digestibility in simulated gastrointestinal tract.
6.5 Amount of protein in plant and remaining protein after processing
6.6 Possible glycosylation of proteins.
6.7 For newly produced proteins, IgE serum test maybe necessary
6.8 Other data requirement on case by case basis
Case 2:
GM stack obtained from conventional breeding
technology where one or both parental lines have
not been approved for commercialization or for food
use, feed use and environment.
� the safety assessment of GM stack and unapproved
parents must be conducted in the same manner as
the single event.
Viet Nam
10/8/2010
12
Viet Nam
(Unofficial English Translation)
Execution Provision states that Decree shall take effect from 10/08/2010 and terminates the Decision no 212/2005/QD-TTg dated on 26
August 2005 of Prime Minister
Viet Nam
Article 1. Scope of application
• stipulates biosafety management of related activities on genetically modified organisms, genetic specimen, and products originating from genetically modified organisms.
• does not apply for biosafety management of pharmaceutical products originating from genetically modified organisms(will follow regulations on pharmaceutical).
Features
• Biosafety management of GMO which have abilities to regenerate a new body will be managed by the regulations of this Decree on biosafety management of genetically modified organisms
• Genetic specimens of GMOs which don’t have abilities to regenerate a new body will be managed by the regulations of this Decree on biosafety management of products of genetically modified organisms.
Risk Assessment Features
1. Scientific, transparent, acceptable
methodologies (to CAN, and to national and
global authorities)
2. Carried out on case-by-case basis depending
on GMO, purpose of use, and receiving
environment
3. Comparative (GM vs non-GM under
comparative conditions)
Viet Nam
• Risk assessment report prepared
• Safety measures proposed
• Risk management report is basis for issuance of biosafety certificate
• Inspection of implementation mandated, via interministerial coordination of Ministry of Environment and Natural Resources
• Covers contained work (MOST), confined tests (MARD), large scale releases (with biosafetycertificate from Ministry of Natural Resources and Environment)
Viet Nam
• Food (Ch. VI sect. 1)and feed (Ch. VI sect. 2) assessments done separately
• Food: – GMO does not contain any uncontrollable risk to human
health as adjudged by Committee for food safety of GMO (Interministerial committee for food safety of GMOs established to appraise the application for granting a certificate that GMOs can be used as food� Ministry of Health)
– GMO allowed as food in at least 5 developed countries and has no confirmed risk (proponent provides documents to prove GMOs has been used as food in 5 developed countries)
10/8/2010
13
Viet Nam
• Feed:
– GMO adjudged not to possess uncontrollable risk
to animal by interministerial committee for animal
feed safety of GMO based on application for a
certificate of use as animal feed.
– Genetically modified organism has been allowed
to use as animal feed in at least 5 developed
countries and have no confirmed risk (provide
documentation)
Viet Nam: Info for RA for food:
General information:
1.Name, address and contact detail of applicant and contact point;
2. GMO common name, scientific name, transformation event and unique identification, if any
Information about recipient organism
1. Name of the recipient organism: common name, scientific name.
2. Information about adverse impact on human health, including: toxicant, allergen and other adverse impact
3. History of use of recipient organism as food
Viet Nam
Information about GMO
1. Detail about inserted gene or genes: sequence, origin.
2. Detail about genetic transformation, including method of transformation, inserted site and number of copies inserted.
3. Detail about genetic stability of GMO.
4. Description of change in phenotype between GMO and recipient organism.
4. Method of detecting genetically modified organism.
5. Information about history of approval and use of genetically modified organism.
Viet Nam
Evaluation of risks caused by GMO to human health
1. Comparison of nutritional composition between
GMO and recipient organism.
2. Possibility of toxicity or allergenicity to humans.
3. Possibility that GMO causes ill-health and other
adverse impacts on human.
4. Other risks if GMO used as food.
Proposed measures for managing risk caused by
GMO to human health
Viet Nam
• Others:
– RA for feed essentially same as that for food
– Goods containing GMO or products of GMO
labeled if GMO content exceeds 5%. Label must
provide info related to GMO.
– Organizations may have some materials
considered as confidential information
– No articulated approach for RA of stacked traitss
10/8/2010
14
COP/MOP5
Risk Assessment and Risk
Management
Articles 15 and 16
(working group 2)
UNEP/CBD/BS/COP-MOP/5/12
30 July 2010
RISK ASSESSMENT AND RISK MANAGEMENT
(ARTICLES 15 AND 16)
Note by the executive secretary
UNEP/CBD/BS/COP-MOP/5/12
page 19
GUIDANCE ON RISK ASSESSMENT OF LIVING
MODIFIED ORGANISMS
Part I: Roadmap for risk assessment of LMOs
Part II: Specific types of LMOs and traits
A. Stacked traits
• Stacked traits
– LMOs with multiple transgenic traits via multigene
casette transformation, re-transformation or co-
transformation � assessed via Roadmap
– LMOs with stacked transgenic traits produced
through cross breeding of 2 or more LMOs �
assessed via proposed guidance document
• “Complements roadmap “for RA
Issues to be consideredAssessment of sequence characteristics at the insertion sites and genotypic
stability
Rationale: Although recombination, mutation and rearrangements are not
limited to LMOs, the combination of transgenic traits via cross breeding
may further change the molecular characteristics of the inserted
genes/gene fragments at the insertion site and/or influence the
regulation of the expression of the transgenes. In addition, changes to
the molecular characteristics may influence the ability to detect the LMO,
which may be needed in the context of risk management measures (see
step 5 of the Roadmap. The reappraisal of the molecular sequence at the
insertion sites, and the intactness of the transgenes may be confirmative
to the molecular characteristics of the parental LMOs, but may also be a
basis for assessing any intended or unintended possibly adverse effects
on the conservation and sustainable use of biological diversity in the likely
potential receiving environment and of potential adverse effects on
human health. The extent of the reexamination may vary case by case
and take into account the results of the parental LMO risk assessment
10/8/2010
15
Issues to be consideredAssessment of potential interactions between combined events and the
resulting phenotypic effects
Rationale: The combination of two or more TraEvs resulting in a StaEv may
influence the expression level of each of the transgenes and there may be
interaction between the genes and the expressed products of the
different transgenes. In addition, the stacked transgenes may alter the
expression of endogenous genes.
Therefore, in addition to information about the characteristics of the
parental single-TraEv LMOs, specific information on potential for
interactions between the altered or inserted genes, stacked proteins or
modified traits and endogenous genes and their products in the StaEv
LMO should be considered and assessed. For example, it should be
assessed whether the different transgenes affect the same biochemical
pathways or physiological processes, or are expected to or may have any
combinatorial effects* that may result in potential for new or increased
adverse effects relative to the parent LMOs.
* Combinatorial – arising from interactions between two or more genes
Issues to be consideredAssessment of combinatorial and cumulative* effects of stacked event
LMOs on the conservation and sustainable use of biological diversity in
the likely potential receiving environment, taking also into account
potential adverse effects to human health
Additional supporting data may be required:
a) Phenotypic charactyeristics, incl. levels of expression; comparison
between LMO and non-LM recipeint organisms.
b) Compositional analysis (e.g., levels of expression, persistence in
environment, potentially harmful effects produced by StaEv in amounts
that differ from those produced by parentals or non-LM organisms (what
if diffusible element that acts on enhancer sequences?)
c) Additional information depending on the nature of the combined traits.
For example, further toxicological analysis of the StaEv may be required
to address any combinatorial effects arising from the stacking of two or
more insecticidal traits that result in a broadened target range or
increased toxicity.
Issues to be consideredIntentional and unintentional StaEv that may have altered environmental
impacts as a result of cumulative and combinatorial effects of stacked
traits prevalent in different LMOs of same species or cross compatible
relatives… Changed impacts on NTO in likely receiving environment
should be taken into account.
Development of specific methods for distinguishing staEvs from parental
LMOs
LMO for which simplified procedure was applied
Bollgard™ Cotton
Roundup Ready™ Cotton
• Bollgard cotton (Colombia)
• RR cotton (Colombia, S.
Africa)
• Bollgard II cotton (S. Africa)
• YieldGard Maize (810-6, S.
Africa)
• YieldGard maize (Bt 11, S.
Africa)
• RR Maize (S. Africa)
• RR soybean (S. Africa)
• RR cotton (Mon 014445, S.
Africa)
• RR YieldGard maize (MON
603 x MON810, S. Africa)
• RR Flex cotton (MON88913-
8, S. Africa) x MON 1445-2)
• RR Bollgard cotton
(MON531-6)
�not likely to have adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human health?
�Implications for stacked trait RA?
Recommended