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References
Risk Assessment of Genetically Modified Food and Feed in Southeast Asia
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)

Flerida A. Cario, Ph. D. Professor, UP Diliman Physical Scientist, DOST BC

Conversations with country regulators and other resource persons General references

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.

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: 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

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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 Natl 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

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

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.

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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*

Output

*interview with Dr. Herman

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 (Colombia) RR cotton (Colombia, S. Africa) Bollgard II cotton (S. Africa) YieldGard Maize (810-6, S. Africa) YieldGard maize (Bt 11, S. Africa) Bollgard Cotton RR Maize (S. Africa) Roundup Ready Cotton RR soybean (S. Africa) RR cotton (Mon 014445, S. Africa) RR YieldGard maize (MON 603 x MON810, S. Africa) RR Flex cotton (MON889138, S. Africa) x MON 1445-2) RR Bollgard cotton (MON531-6)

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.

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?

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 Principles
3. 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

LMO for which simplified procedure was applied

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) Bollgard Cotton RR Maize (S. Africa) Roundup Ready Cotton RR soybean (S. Africa) RR cotton (Mon 014445, S. Africa) RR YieldGard maize (MON 603 x MON810, S. Africa) RR Flex cotton (MON889138, 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?

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Safety assessment records:

The nutritional equivalence and wholesomeness of GTS 40-32 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

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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

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Thailand

Thailand

No English Translation

No English Translation

Thailand

Thailand
Based on references, a few words and footnotes written in English, RA seems to follow Codex Alimentarius Guidelines:
No English Translation

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 RecombinantDNA Plants (CAC/GL 45-2003)

Thailand
Food safety assessment system in place, BUT: Cabinets 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.
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

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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 - Dept 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 hybrids 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.

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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. b. c. d. e. Molecular weight of proteins Amino acid sequences Immuno- reaction Post translational modifications 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

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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).

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

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 dont 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 biosafety certificate 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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Risk Assessment and Risk Management COP/MOP5

Articles 15 and 16 (working group 2)

UNEP/CBD/BS/COP-MOP/5/12 page 19
UNEP/CBD/BS/COP-MOP/5/12 30 July 2010

RISK ASSESSMENT AND RISK MANAGEMENT (ARTICLES 15 AND 16) Note by the executive secretary

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 cotransformation assessed via Roadmap LMOs with stacked transgenic traits produced through cross breeding of 2 or more LMOs assessed via proposed guidance document

Issues to be considered
Assessment 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

Complements roadmap for RA

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Issues to be considered
Assessment 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 considered
Assessment 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 considered
Intentional 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 (Colombia) RR cotton (Colombia, S. Africa) Bollgard II cotton (S. Africa) YieldGard Maize (810-6, S. Africa) YieldGard maize (Bt 11, S. Africa) Bollgard Cotton RR Maize (S. Africa) Roundup Ready Cotton RR soybean (S. Africa) RR cotton (Mon 014445, S. Africa) RR YieldGard maize (MON 603 x MON810, S. Africa) RR Flex cotton (MON889138, 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?

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