04. Dr. Flerida Carino - Risk Assessment of GM Crops in ASEAN

10/8/2010

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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

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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

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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.

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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

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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. “

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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


Bollgard™ Cotton




Africa)



Africa)


Africa)




Africa)






(MON531-6)




10/8/2010

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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 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. “


“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.“


“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

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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

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Thailand

No English Translation

Thailand


Thailand


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

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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.


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.

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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.


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


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


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

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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)

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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

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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

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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


Bollgard™ Cotton




Africa)



Africa)


Africa)




Africa)






(MON531-6)




Documents

04. Dr. Flerida Carino - Risk Assessment of GM Crops in ASEAN