Update from EFSA on GMO applications, mandates …Crop Maize (21) Soybean (8) Cotton (5) Oilseed...

Irina Olaru 8th GMO Network Meeting 23 May 2017

Update from EFSA on GMO applications, mandates and other activities

2

Applications under 1829/2003

Under Articles 5 and 17

Renewals under Articles 11 and 23

Guidance documents and explanatory notes

External mandates

Procurement and grants

EFSA ACTIVITIES ON GMO

3

APPLICATIONS

Applications under 1829/2003, Art 5 & 17

Completeness check (5)

Risk assessment (32)

Finalised (80)

Withdrawn (24)

4

APPLICATIONS

Crop

Maize (21)

Soybean (8)

Cotton (5)

Oilseed rape (3)

APPLICATIONS UNDER 1829/2003, ART 5 & 17 – CC + RA PHASE (37)

5

APPLICATIONS

Level of stacking

Singles (13)

2-event stacks (6)

3-event stacks (6)

4-event stacks (7)

5-event stacks (3)

6-event stacks (2)

M (2) S (2) C (1) O (1)

M (1) S (3) C (2)

M (6) S (1)

M (3)

M (2)

APPLICATIONS UNDER 1829/2003, ART 5 & 17 – CC + RA PHASE (37)

M (7) S (2) C (2) O (2)

M=maize S=soybean C=cotton O=oilseed rape

6

Renewal applications under 1829/2003, Art 11 & 23

Under risk assessment: 6 (OSR GT73; OSR MS8, RF3 and MS8 x RF3; maize GA21; sugar beet H7-1; maize NK603 x MON 810; maize 1507 x NK603)

Finalised: 2 (maize 1507 and maize 59122)

APPLICATIONS

7

Guidance documents under development or recently finalised

Low Level Presence GD – item 4.4 of the agenda

Allergenicity GD – item 5.1 of the agenda

Explanatory notes

Literature review – item 4.3 of the agenda

Next Generation Sequencing – item 5.2 of the agenda

GUIDANCE DOCUMENTS AND EXPLANATORY NOTES

8

MON810 PMEM annual reports – item 6.2 of the agenda

Additional information on maize Bt11 x MIR162 x MIR604 x GA21 (Application 66) – finalised March 2017

Additional information on maize 5307 (Application 95) – received in December 2016, on-going

Additional information on maize 3272 (Application 34) – received in April 2017, on-going

EXTERNAL MANDATES

9

Impact of teosintes – item 6.3 of the agenda

Scientific assistance on Bohn et al., 2016 in relation to the risk assessment of genetically modified Bt crops

Scientific assistance on the commentary published by Kruse-Plass et al. (2017), in relation to the risk assessment of the GM Bt Maize crops

EXTERNAL MANDATES

10

Sequencing mandates

Finalised: 3 (maize GA21, maize MIR604, maize 59122)

On-going: 2 (soybean 305423, soybean 40-3-2)

EXTERNAL MANDATES

11

Contractor support on:

Bioinformatics

Statistical analyses

Toxicological analyses

Literature review of baseline information to support the risk assessment of RNAi-based GM plants – finalised, item 7.2 of the agenda

Literature review of baseline information on RNAi that could support the food/feed and environmental risk assessment of RNAi-based GM plants – on-going

PROCUREMENT AND GRANTS

12

www.efsa.europa.eu/en/engage/careers

www.efsa.europa.eu/en/rss

Subscribe to

Engage with careers

Follow us on Twitter

@efsa_eu

@plants_efsa

@methods_efsa

www.efsa.europa.eu/en/news/newsletters

STAY CONNECTED!

23 May 2017 8th GMO Network Meeting Elisabeth Waigmann

Risk assessment of subcombinations

2

IR 503/2013 (Annex II, 2.2):

“for stacked GM plants, whose cultivation is associated with the production of GM material containing various subcombinations of events (segregating crops), the application shall include all subcombinations independently of their origin which have not yet been authorised.”

“In such case, the applicant shall provide a scientific rationale

justifying that there is no need to provide experimental data for the concerned subcombinations or, in the absence of such scientific rationale, provide the experimental data”

BACKGROUND

3

‘subcombinations’ = lower stacks containing combinations of up to N-1 of the events present in the high stack

Subcombinations can be obtained in two ways:

By segregation in the progeny of the high stack

through targeted breeding programs, by conventional crossing

BACKGROUND

4

F1 AxBxCxD (high stack)

Harvested F2 kernels will contain: - high stack AxBxCxD - 3-event subcombinations: AxBxC; AxBxD; AxCxD; BxCxD - 2-event subcombionations: AxB; AxC; AxD; BxC; BxD; CxD - singles: A; B; C; D.

Segregation will occur on the cob

Subcombinations obtained by segregation from the high stack

BACKGROUND

hemizygous

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwioxsWxsuXLAhXB2xoKHc9RAVcQjRwIBw&url=http://www.seriouseats.com/2014/03/guide-to-whole-grains-ancient-grains-gluten-free-types-of-grains.html&bvm=bv.117868183,d.ZWU&psig=AFQjCNE0x7iyckW-H8HTVs-ICEwGAQDzqQ&ust=1459323623487628

5

Subcombinations obtained through targeted breeding programs

Example subcombination AxBxD:

BACKGROUND

AxB D (done by breeding company)

F1: AxBxD hemizygous

targeted breeding program

x

F1: AxBxD hemizygous

marketed to farmers

6

Define a GMO Panel approach for the risk assessment of subcombinations independently of their origin, i.e. obtained by segregation or through targeted breeding programs, as required in IR 503/2013

GMO panel approach will be published as an annex to the May 2017 plenary meeting minutes, in line with the EFSA goal to provide transparency in the risk assessment process

Covers maize and oilseed rape

GOAL

7

Subcombinations obtained by segregation in the progeny of the high stack (e.g. F2 generation in harvested grains/seeds)

present in F2 grain/seed mixture of the high stack

not intended to be further propagated

are an integral part of the assessment of the high stack

the assessment of sub-combinations occurring by segregation needs no further consideration.

RISK ASSESSMENT STRATEGY

8

Subcombinations obtained through targeted breeding programs

stacks in themselves which can be bred, produced and marketed independently of the higher stack

The strategy to assess these sub-combinations needs further consideration


9

The assessment of subcombinations needs to encompass intended and unintended effects, as for any other stack

Intended effects - directly linked to the objective(s) of the genetic modification(s)

Unintended effects - not directly linked to the objective(s) of the genetic modification(s). On the basis of current knowledge of the introduced trait(s), these can be either expected or unexpected


10

The challenge:

these subcombinations may not even exist at the moment of submission of the high stack application,

experimental data to identify intended and unintended effects might not be available.

it is also possible that some of these subcombinations have been the object of past applications and assessed by the EFSA GMO Panel


11

The GMO Panel considers that the assessment of subcombinations obtained through targeted breeding programs can be performed on the basis of:

RA of the single events;

RA of the high stack;

RA of relevant specific subcombinations (if available);

specific data/information that may be required on a case-by-case basis.


12

Assessment of:

intended and expected unintended effect(s) linked to the genetic modification

unexpected unintended effect(s) potentially linked to the genetic modification


13

Intended and expected unintended effect(s) linked to the genetic modification

When the RA has identified effects linked to the single events or the high stack, the risk associated to particular subcombinations can be anticipated.

Two scenarios:

a) An effect linked to specific subcombinations is expected

Effect relevant to safety of the subcombinations additional data is requested

Effect not relevant to safety of the subcombination no additional data needed

b) No effect linked to specific subcombinations of the events is expected no additional data needed


14

Unexpected unintended effect(s) potentially linked to the genetic modification

If an unexpected unintended effect is identified for the high stack and/or any of the single events, it is assessed as an expected unintended effect, and its associated risk in specific subcombinations of the events is considered as described previously

If no unexpected unintended effect is identified, the assessment will be performed on the basis of the available information no additional data needed


15

The opinion will report (i) the assumptions made to complete the assessment of subcombinations, (ii) possible remaining uncertainties, as well as (iii) if appropriate, strategies to reduce such uncertainties.

Example of implementation of the strategy can be found in the scientific opinion on application 119.


16



Subscribe to

Engage with careers


@efsa_eu

@plants_efsa

@methods_efsa


STAY CONNECTED!

23-24 May 2017 – GMO RA Network MTG – Yann Devos (EFSA GMO Unit)

Explanatory note on literature searching

2

3

Submission types

GMO market registration applications (APs) submitted under Regulation (EC) No 1829/2003 before and after the Implementing Regulation (EU) No 503/2013 (IR) entered into force [GMO APs]

Annual post-market environmental monitoring reports on GMOs authorised for commercial cultivation in the EU [annual PMEM reports]

GMO APs for the renewed market authorisation of authorised GM food/feed under Regulation (EC) No 1829/2003 [renewal APs]

SCOPE OF EXPLANATORY NOTE

4

GMO APs submitted after the IR came into force

IR requires a systematic review (SR) covering the 10 years before the submission of the GMO AP

GMO APs submitted before the IR came into force

Complement GMO APs with relevant findings published in the scientific literature during the regulatory review process


5

Annual PMEM reports

European Commission’s authorisations require to actively screen relevant scientific publications

Renewal APs

EFSA GMO Panel (2015) requires to search all scientific databases relevant for the three main areas of the risk assessment in a comprehensive and structured manner, in order to retrieve new scientific information relevant to the safety of the GMO for market renewal


6

Observations

Applicants have undertaken literature searches to various degrees of rigour

Lack of clarity on how to address the SR requirement of the IR

AIM OF EXPLANATORY NOTE

7

Aim

To clarify the scope and methodology for literature searching

To give recommendations on how to conduct, report systematic/extensive literature searches, and present the results of any scoping reviews

To complement EFSA (2010) on the application of SR methodology to food/feed safety assessments to support decision making, with GMO-specific guidance

AIM OF EXPLANATORY NOTE

8

Applicants

To provide a more rigorous and standardised/harmonised approach to literature searching

To perform more consistent and sensitive literature searches, and improve reporting

To minimise biases (such as publication bias)

Risk assessors and regulators

To provide guidance on how to check/appraise systematic/extensive literature searches

INTENDED USERS OF EXPLANATORY NOTE

9

Scoping reviews


Systematic/extensive literature searches

GMO APs submitted before the IR came into force

Annual PMEM reports

Renewal APs

STRATEGY OF EXPLANATORY NOTE

10

Scoping reviews


IR requires a SR

Not always useful/necessary to perform SR

IR allows for derogation

Reasoned justification required

Outcome of scoping review can determine whether it is useful to perform SR and for which topics

STRATEGY OF EXPLANATORY NOTE

11

Framework consisting of five successive steps

1. Identifying review questions and clarifying their purpose (Section 3.1)

2. Searching for/identifying relevant studies (Section 3.2)

3. Selecting studies (Section 3.3)

4. Extracting high level data of the relevant studies (Section 3.4 – only applicable to scoping reviews)

5. Summarising and reporting the data, and considering the implications of findings (Section 3.5)

STRUCTURE OF EXPLANATORY NOTE

12

Appendices

A – Categories of information/data requirements

B – Search strategy examples (#4)

C – Examples of web-based databases that can contain relevant information supporting the risk assessment of GMOs

D – Requirements for undertaking scoping reviews applicable to systematic/extensive literature searchers

STRUCTURE OF EXPLANATORY NOTE

13

Problem to address should be specified in the form of clear, unambiguous and structured questions

Link to GMO risk assessment context

Review questions should be broken down into their key elements to guide the development of search terms and structure the search:

1. Structured questions (e.g. PICO, PECO)

2. Information/data requirements outlined in relevant GMO Panel guidance documents, EFSA explanatory notes and IR (see Appendix A)

1. IDENTIFY REVIEW QUESTIONS/CLARIFY THEIR PURPOSE

14

1. Structured questions (e.g. PICO, PECO)

“Does either the GMO and derived food/feed products, or the intended trait(s), have adverse effects on human and animal health and the environment?”

P = population [human/animal health/environment]

I/E = intervention/exposure [GMO, derived food/feed products, intended trait(s)]

C = comparator

O = outcome [adverse effects]


15

2. Information/data requirements outlined in relevant GMO Panel GDs, EFSA explanatory notes and IR (see Appendix A)

Examples

Protein expression data

90-day feeding studies in rodents

Laboratory/greenhouse feeding bioassays with representative non-target organisms

…


16

Literature searching involves:

1. Developing a search strategy

2. Identifying information sources to search

2. SEARCH FOR/IDENTIFY RELEVANT STUDIES

17


Approaches to develop searches

Single search strategy

Series of focused search strategies

Search strings (link to key elements of review questions)

See Appendix B

• Search terms

• Search functions

• Search operators


18


Language

Time period

Reference study searches

List of reference studies

Results of searches with reference studies

Appraisal (EFSA critical appraisal tool [CAT])


19

2. Identifying sources of scientific literature

Electronic bibliographic databases

Mandatory

At least two multi-disciplinary databases for complementarity (e.g. Web of Science Core Collection, Scopus, CAB Abstracts, Medline)

Optional

Searching more specialist/subject-specific databases (e.g. Agricola)


20


Internet searches (limit publication bias)

Mandatory

Internet pages of relevant key organisations involved in GMO risk assessment (e.g. FDA, USDA, US EPA)


21


Internet searches (limit publication bias)

Optional

Scientific literature that is not indexed in electronic bibliographic databases via general search engines such as Google scholar (check first 200-300 hits)

Web-based databases known to contain information specifically on effects of GMOs (examples given in Appendix C)


22


Manual searches

Mandatory

Checking reference list from recent relevant reviews, methodological publications and scientific opinions

Optional

Hand-searching key journals or assessing journal contents pages

Citation searching


23

Determining “relevance”

Set eligibility/inclusion criteria to determine relevance of the retrieved studies

Table 1 gives examples of eligibility/inclusion criteria

Reliability of relevant studies is assessed later in the process

3. SELECT STUDIES

24

3. SELECT STUDIES

25

3. SELECT STUDIES

26

Process (2 stages)

1. Rapid assessment based on title-abstract-keywords

2. Detailed assessment of full-text documents

Quality assurance

Relevant screening performed by more than 1 reviewer

Ensure inter-reviewer agreement

Resolve disagreement

3. SELECT STUDIES

27

Classification of studies retrieved

Relevant studies

To summarise and consider those for reliability

Non-relevant studies

Give reason(s) for exclusion based on eligibility/inclusion criteria

Unobtainable studies & studies with unclear relevance

Describe (unsuccessful) methods used to try to obtain a copy of the study

Give justification of why relevance cannot be definitively determined

3. SELECT STUDIES

28

Data extraction [only for scoping reviews]

Purpose

Enable applicants to describe the overall volume, strength and direction of the studies

Possible variables

Authorship, year of publication, source, title of the study, objective of the study, experimental design, main results, conclusion, protection goal considered, applicable category of information/data requirement, whether adverse effects are reported on human/animal health and/or the environment, …

4. EXTRACT HIGH LEVEL DATA OF RELEVANT STUDIES

29

Summarising and reporting the data

Search methods and outcomes

Results of study selection process

See template tables 2 to 5

Narrative synthesis/summary of relevant studies, describing their overall volume, strength and direction [only applicable to scoping reviews]

See template tables 6

5. SUMMARISE AND REPORT

30

Considering implications of the findings

Value of undertaking SR [only applicable to scoping reviews]

Implications for risk assessment

To assess the reliability and implications for the risk assessment of all relevant studies retrieved after detailed assessment of full-text documents for relevance: ordered by category of information/data requirement(s) (see template Table 7)

5. SUMMARISE AND REPORT

31

Applicability of the explanatory note

Six months after publication date of the note

New submissions submitted after 10 OCT 2017

Except for:

Extensive/systematic literature searchers previously submitted to EFSA that do not comply with minimum quality standards

Updates of extensive/systematic literature searchers previously submitted to EFSA

TRANSITION PHASE

32

EFSA’s completeness checklist

To be completed by applicants

To ensure adequate reporting to facilitate appraisal and reproducibility

How?

Appendix to EFSA’s updated submission guidance on applications for authorisation of GM plants under Regulation (EC) No 1829/2003

Attached to GMO Panel/EFSA questions asking for updated or revised literature searches

COMPLETENESS CHECKLIST

33

Explanatory note may/will be revised:

when experience is gained in its application

in view of any amendments to the IR

FUTURE UPDATES OF EXPLANATORY NOTE

34

ACKNOWLEDGEMENTS

Thank you for your attention

EFSA wishes to thank the following for the support provided to this scientific output: Elisa Aiassa, Fernando Álvarez, Hermann Broll, Giacomo De Sanctis, Antonio Fernandez Dumont, Andrea Gennaro, Anna Lanzoni, Nikoletta Papadopoulou, Konstantinos Paraskevopoulos and Matthew Ramon, and experts of the GMO Panel standing Working Groups on Molecular Characterisation, Food/Feed, and Environmental Risk Assessment for inspiring discussions that helped to develop the explanatory note to the guidance

35



Subscribe to

Engage with careers


@efsa_eu

@plants_efsa

@methods_efsa


STAY CONNECTED!

Guidelines on possible derogation of existing requirements for applications of GM food and feed at low levels submitted under Regulation (EC) No 1829/2003

Anna Lanzoni 8th GMO Network Meeting 23 May 2017

2

Introduction

The mandate on GMO Low Level Presence (LLP)

Project plan and schedule

Stakeholders engagement

EU Member States consultation

The draft guidance: key points

Q&A

ROADMAP

3

Introduction






Q&A

ROADMAP

4

Mandate from European Commission

Mandate on possible derogation of existing requirements for applications of GM foods and feeds at low levels submitted under regulation (EC) No 1829/2003

Received by EFSA in 2014

Clarification requested to EC

Accepted by EFSA in 2015 (EFSA-Q-2015-00432)

THE MANDATE ON GMO LOW LEVEL PRESENCE (LLP)

5

PROJECT PLAN AND SCHEDULE

LLP

Sept 2017

July 2015

2 May-13 June 2017 (6-week)

Sept 2016

1st draft guidance

EU MS consultation

Public consultation

2nd draft guidance

GMO Panel Guidance

28 Oct–9 Dec 2016 (6-week)

Apr 2017

Josep Casacuberta Adinda De Schrijver Achim Gathmann Mikolaj Gralak Elsa Nielsen Francesco Visioli - Chair Jean-Michel Wal

Yann Devos Antonio Fernandez Anna Lanzoni –Task leader Claudia Paoletti Konstantinos Paraskevopoulos Hearing expert: Thomas Frenzel

LLPWG

6

Introduction






Q&A

ROADMAP

7

Two-step approach

Dedicated EU Member States Consultation 28 October - 9 December 2016

Public Consultation

ongoing, ending 13 June 2017

STAKEHOLDERS ENGAGEMENT

8

The process

EU MS CONSULTATION

EFSA LLP WG

Advisory Forum

EFSA Focal Points

MS Competent Authorities under

1829/2003

EFSA Focal Points

9

EU MS CONSULTATION

The tools

10

240 comments

summarised replies will be provided in a Technical report with those from Public Consultation

EU MS CONSULTATION

The outcome

11

Main comments

Readibility

Scientific contents

reassurance on the appropriateness on most EFSA proposals

relevant scientific points raised

Risk management issues EC involvement

Threshold

Scope (“large size” fruit/vegetables)

Asynchronicity/asimmetry & mutual recognition

EU MS CONSULTATION

12

Introduction





The draft guidance - key points

Q&A

ROADMAP

13

Improved instructions for use

Not a stand-alone document!

This document is intended to assist applicants … by indicating which technical requirements of Annex II of Regulation (EU) No 503/2013 are necessary and which are not, in this case providing justification, in order to conclude on the safety of a GMO in a LLP application

This document supports Regulation (EU) No 503/2013 and it is not intended to serve as a stand-alone guidance

DRAFT GUIDANCE – IMPROVED READIBILITY VS V1

See: 3.1 Introduction

14

NOT A STAND-ALONE DOCUMENT

15

GMO at maximum 0.9% per ingredient

point of entry consumer

GMO at >0.9% per ingredient : not in the remit of this guidance

e.g. GM fruits and vegetables constituting either a full portion or part of a consumed portion, resulting in an exposure of consumers (or animals) higher than 0.9% to that GMO

DRAFT GUIDANCE - SCOPE

See: 1.2 Interpretation of the Terms of Reference

16

LLP application: covers a request for the authorisation of a GMO present at a level of maximum 0.9% per ingredient in any food and/or feed, submitted under Regulation (EC) 1829/2003

LLP GMO: the GMO subject of the LLP application

LLP Ingredient: the mixture of the LLP GMO and the same plant species and/or derived product, at the predefined proportion of a maximum of 0.9% and 99.1% respectively

DRAFT GUIDANCE - DEFINITIONS

See: 1.2 Interpretation of the Terms of Reference

17

Stand-alone dossier

Comprehensive characterisation of the transformation event (intended trait)

Fit-for purpose assessment driven by:

low exposure

under acute/chronic scenarios

DRAFT GUIDANCE - SCIENTIFIC DRIVERS

18

MAIN “DEROGATIONS” FROM REGULATION (EU) 503/2013 – AT A GLANCE

Molecular characterisation

• Expression of the insert Singles: only edible parts Stacks: not routinely needed • RNAi off targets Not necessary

Comparative assessment

• ONLY for output traits, hypothesis-driven situations, de novo compounds • Targeted compositional analysis, not full list of OECD consensus docs compounds • No equivalence test necessary • Greenhouse/field trials acceptable • # sites • No agronomic and phenotypic characteristics assessment on a routine basis • Codex-aligned studies acceptable

Food Feed Assessment

• No 90-day studies • No endogenous allergens measurements on a routine basis • No nutritional assessment

19

Environmental Risk Assessment: case-specific

varying depending on the biology of the plant species, the intended trait(s), the potential receiving environments, and interactions among all three

IN ADDITION

20

Not mandatory on a routine basis

Since in LLP situations the level of exposure of consumers and animals to the LLP GMO is defined to be at a maximum 0.9% per ingredient, not all differences in comparative analysis endpoints between the LLP GMO and the plant (and/or derived product) constituting the remaining part of the ingredient may be relevant

Why? Which difference might be relevant in LLP?

FOCUS ON COMPARATIVE ANALYSIS

See 3.2.3.3 Comparative analysis

21

The level of an endogenous compound in a LLP ingredient is determined by:

the level of such endogenous compound in the LLP GMO (and/or derived product)

the level of such endogenous compound in the plant (and/or derived product) constituting the remaining part of the ingredient.

The ratio between these two levels determines the extent to which the level of the compound of the LLP GMO impacts the overall level of that compound in the LLP ingredient



22


LLP ingredient LLP GMO remaining part of the ingredient

+ =

en

do

gen

ou

s

com

po

un

d

Cas

e 1

C

ase

2

Cas

e 3

23


Level of a compound in LLP GMO/ level of the compound in the ingredient without the LLP GMO

Level of the compound in LLP ingredient/ level of the compound in the ingredient without the LLP GMO

0 0.991

0.001 0.991009

0.01 0.99109

0.1 0.9919

1 1

10 1.081

20 1.171

50 1.441

90 1.801

100 1.891

200 2.791

1

Table 1: Impact of variations in the levels of an endogenous compound in a LLP GMO on the level 1 of the same compound in a LLP ingredient. 2

Case 1

Case 2

Case 3


24

On the basis of the current knowledge, the GMO Panel is of the opinion that variations in the level of compound(s) in LLP GMOs are generally not large enough to impact on the nutritional or safety characteristics of the LLP ingredient

POSSIBLE EXCEPTIONS

GMOs with output traits developed to improve nutrition

GMOs expected to show compositional changes on the basis of precedent investigations



25

Therefore:

No comparative assessment on a routine basis

Compositional analysis only if:

the intended trait targets the composition of the LLP GMO (output trait)

a hypothesis for a relevant compositional change can be formulated based on available information from the hazard identification (e.g. unintended compositional changes anticipated by the precedent analyses)

compounds are de novo produced in the LLP GMO

No comparative analysis of agronomic/phenotypic characteristics



26

Implementation

Targeted compositional analysis

No full list of OECD consensus doc compounds

Conditions maximising expected change(s), based on available knowledge

field trials, greenhouse studies

Equivalence test not considered necessary



27

Comparative assessment studies performed under non-EU regulatory frames: applicability in LLP applications

studies conducted in accordance with Codex (Codex Alimentarius, 2009) could support the assessment

studies not aligned to requirements of Codex are not considered appropriate by the GMO Panel.



28

Testing of whole genetically modified food and feed (Regulation [EU] No 503/2013; Annex II. II, 1.4.4 subsections 1.4.4.1-1.4.4.3)

the GMO Panel considers that a 90-day feeding study is not needed to corroborate information on the toxicological characteristics of the whole LLP GM food and feed in rodents and/or to reduce the remaining uncertainties, considering the limited exposure to the LLP GMO

FOCUS ON TOXICOLOGY

See 3.2.3.4 Toxicology

29

The assessment of the allergenicity of food or feed from the LLP GMO should be conducted in the case changes in the levels of endogenous allergens are expected in the LLP GMO, possibly impacting the allergenicity of the LLP ingredient

In such situations, relevant identified endogenous allergens should be analysed and the assessment should indicate whether the GMO could impact the allergenicity of the LLP ingredient

FOCUS ON ALLERGENICITY

See 3.2.3.5 Allergenicity

30

Considering that the scope of LLP applications is limited to a level of maximum 0.9% of a LLP GMO per ingredient a nutritional assessment is not considered necessary on a routine basis, unless relevant changes in the levels of food and feed constituents from the LLP GMO are expected

FOCUS ON NUTRITIONAL ASSESSMENT

See 3.2.3.6 Nutritional assessment

31

In the case of multiple LLP applications for LLP GMOs showing similar traits, the possible cumulative contribution from the various LLP GMOs to the ingredient should be taken into consideration in the risk assessment

the relative contribution to the ingredient of each of these taken into account to allow an estimation of their total contribution via the addition of the respective trait-related constituent(s)

Case-by-case, on the basis of compositional analysis outcome

CUMULATIVE RISK ASSESSMENT

See 3.2.5.3 Cumulative risk assessment

32

Thank you

Questions?

33



Subscribe to

Engage with careers


@efsa_eu

@plants_efsa

@methods_efsa


STAY CONNECTED!

Allergenicity guidelines (EFSA-Q-2014-00547)

Antonio Fernandez Dumont 8th GMO Network Meeting 23 May 2017

2

• Self-task activity (initiated by EFSA)

- Non-IgE-mediated immune adverse reactions to foods - In vitro protein digestibility - Endogenous allergenicity

• Stakeholders engagement

- EFSA Workshop (June 2015) - Public consultation (July-September 2016) - EFSA Info Session (November 2016) - «Focus group» interactive consultation body

Allergenicity guidelines

3

Non-IgE-mediated immune adverse reactions to foods

• Risk Assessment to focus on celiac disease

- Clear cause-effect relationship

• Risk assessment considerations

- Stepwise approach

• Annex A

- Additional considerations - Examples


4


5


6

• Risk assessment considerations

- Usefulness of protein digestion - Types of in vitro digestibility tests - An interim phase needed – EFSA procurement

• Annex B

- Additional considerations for the interim phase - Examples


In vitro protein digestibility

7


8


9

• Relevant crops for the analysis

• Relevant allergens to be quantified

• Methodology

• Data interpretation

• Annex C

- Additional considerations - Examples


Endogenous allergenicity

10


11

Thank you very much for your attention!


Acknowledgement: EFSA would like to thank the members of the Allergenicity Working Group: Eigenmann Philippe, Epstein Michelle, Hoffmann-Sommergruber Karin, Koning Frits, Lovik Martinus, Mills Clare, Moreno F. Javier, van Loveren Henk, Wal Jean-Michel; the EFSA trainee Selb Regina and the EFSA staff member Fernandez Dumont Antonio for the scientific discussions and the preparation of the guidance document

Presented by Nikoletta Papadopoulou GMO Unit Parma, 23-24 May 2017

Explanatory Note on Next Generation Sequencing

2

This presentation represents the state of discussion at the time of the GMO Network meeting, 23-24 May 2017, and does not necessarily reflect the final outcome.

3

NEXT GENERATION SEQUENCING (NGS)

Library

Construction

Cluster Amplification

Alignment and data analysis

(reference genome)

Sequencing

Genomics (whole genome sequencing, exome sequencing,

de novo and targeted sequencing)

Transcriptomics (total RNA and mRNA sequencing, targeted RNA

sequencing, small RNA and ncRNA sequencing)

Epigenomics (Methylation sequecning, ChIP sequencing,

ribosome profiling)

4

NGS is used for the molecular characterisation of the GM plant insert, in the context of GMO applications for EU market authorization, and specifically for:

Characterisation of the T-DNA insertion site in the

plant genome and its junction sites

Detection of backbone plasmid in the GM plant genome

Generational stability/integrity of a T-DNA

NGS IN GMO APPLICATIONS

5

To provide recommendations on the information that

should be submitted in GMO applications so that EFSA

can perform its quality assessment

To provide a standardised approach to NGS

AIM OF THE NOTE TO GUIDANCE

6

PREPARATION OF THE NOTE TO GUIDANCE

Consultation by the Molecular Characterisation

WG experts

Experience from assessing applications using NGS

Published literature

7

I. Sequence data and quality

II. Read depth: Whole genome sequencing

approach or Sequence capture approach

III. Read alignment to a reference genome

IV. Description of data and processing

DESCRIPTION OF QUALITY PARAMETERS FOR RA

8

Library construction methods and sequencing

platforms

Paired or single-end read sequencing, but for

characterisation of integration sites: longer read

lengths are required.

Junction read analysis involves detection of chimeric

reads (mapped to insert and host genome)

Number and quality statistics of reads (FASTQC)/run

I. SEQUENCE DATA AND QUALITY

9

Whole genome sequencing approach

Calculation of the number of reads required to cover the genome to a specified depth:

e.g. by Lander-Waterman algorithm

Coverage = 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑟𝑒𝑎𝑑𝑠∗𝑟𝑒𝑎𝑑 𝑙𝑒𝑛𝑔𝑡ℎ

𝑒𝑠𝑡𝑖𝑚𝑎𝑡𝑒𝑑 𝑔𝑒𝑛𝑜𝑚𝑒 𝑠𝑖𝑧𝑒

Identification approach by Willems et al, 2016 (statistical framework for estimating the probability of sequencing junction reads)

Sequence capture approach to enrich for target sequences

II. READ DEPTH

10

Genome coverage:

The degree of validation of sequence coverage is greatly dependent on:

- the organism in question

- the availability of genomic resources

Examples are provided in the Note to Guidance

III. READ ALIGNMENT TO A REFERENCE GENOME

11

Read numbers per sequencing run (raw and

calculated/probability formula)

Data on coverage of reference genes (from read

alignment)

Number of reads when trimmed or removed during

analysis

Description of bioinformatics analysis; step-by step

Parameters and versions of software used

IV. DESCRIPTION OF DATA AND PROCESSING

12

NOTE TO THE GUIDANCE ON NGS- PUBLICATION

Publication: June 2017

EFSA webinar: 11th July 2017

13

Simon Moxon

Molecular Characterisation (MC) WG Experts

GMO Unit Colleagues

ACKNOWLEDGMENTS

Assessment of site representativeness

Andrea Gennaro and Giacomo De Sanctis 23 May 2017 8th GMO Network ERA break-out session

2

PART 1

The objective of this presentation

The importance of site selection

The site representativeness in the EFSA 2011 FF guidance and IR 503/2013

Strategy proposed in the EFSA 2015 agro/pheno guidance

PART 2

Classification of the cultivation conditions

Graphical representations

Assessment of representativeness of selected sites

Conclusion on site representativeness

OUTLINE

3

To present a strategy to assess the representativeness of the selected sites where the

field trials are conducted

OBJECTIVE

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwicsM6z5ODUAhUQI1AKHXl1DI8QjRwIBw&url=http://www.imagequiz.co.uk/quizzes/21449037&psig=AFQjCNE2U8TR-xLalk1T2tArJu4ViDgDmA&ust=1498747666616169


4

WHY SITE REPRESENTATIVENESS IS IMPORTANT

Mole

cula

r chara

cte

risation

Agro

/Pheno

Com

positio

nal

Comparative approach is followed to identify intended and unintended differences between GM plant and the conventional counterpart

The risk assessment of GM plants starts with hazard identification (as part of problem formulation)

Selected sites Field trials conditions

Test materials

Intended and unintended changes

5

… WHICH ARE THE IMPLICATIONS OF SITE SELECTION?

Seedling – Vegetative phase – Reproductive phase - Harvest

Seeds FIELD TRIAL Seeds

Agronomic and phenotypic characterisation

Compositional analysis

This information is used to drawn conclusions on materials produced under conditions different from those tested to support the specific application

6

EFSA Guidance on RA of food and feed from GM plants

and

Implementing regulation (EU) 503/2013

Each field trial shall be replicated at a minimum of eight sites

The replication at each site is the number of results obtained for each test material; the replication should never be less than four at any site.

HOW MANY SITES AND REPLICATES

7

EXPERIMENTAL DESIGN: THE MINIMAL REQUIREMENTS

8 sites, 1 GM plant, 1 comparator, 6 reference varieties (3 per site)

Randomised Block Design

GM CC Ref

Single plant

Plot

Single row

Number of plants/plot is related to the phenotypic characteristics of the crop and to the applied agricultural practices

Blo

ck1

Blo

ck2

Blo

ck3

Blo

ck4

8

be representative of the range of receiving environments where the crop will be grown, thereby reflecting relevant meteorological, soil and agronomic conditions; the choice should be explicitly justified.

THE PRINCIPLES OF SITE SELECTION

reflect the different meteorological and agronomic conditions under which the crop is to be grown; the choice shall be explicitly justified.

From the EFSA guidance and IR, it is clear the importance of site selection and its justification

The different sites selected for the field trials shall

EFSA Guidance on RA of food and feed from GM plants 2011

Implementing regulation (EU) 503/2013

9

Site selection justification in import & processing applications:

…field trial sites were selected in areas where the crop is typically cultivated in the USA

OR

…the selection was based on the representativeness of the region for the crop production and the availability of GLP compliant test sites

Site selection and/or the representativeness of the sites selected by the applicants in frequently challenged by MS.

It was considered important:

more clarity to applicants on how sites should be selected

more transparency in the assessment of site representativeness

SITE SELECTION NOT SUFFICIENTLY JUSTIFIED

10

The agro/pheno guidance provides recommendations on how to select and manage the field trials

The principle to be follow is:

The selection should be able to capture enough variability within the set of possible receiving environments in which the test materials can be grown

To agro/pheno guidance requests specific information to support the appropriateness of site selection such as:

geographical location

agrometeorological data

soil characteristics

crop management practices

SITE REPRESENTATIVENESS IN THE AGRO/PHENO GD

11

EXAMPLE OF SITE SELECTION

Step I: delineate the boundary within which sites for the trials could be selected (e.g. acreage)

Step II: further delineation of boundaries based on additional factors (e.g. maturity group that is related to the tested materials)

12

EXAMPLE OF SITE SELECTION

Step III: sites identification, including sites outside optimal growing area

3 examples for a soybean (maturity group III)

Representative Variable Appropriate for the GM line

13

Key factors to evaluate site representativeness of selected sites (requested in agro/pheno GD):

geographical locations

meteorological conditions

soil characteristics

management practises

REPRESENTATIVENESS OF SELECTED SITES

How? Multi-factors Transparent Repeatable Component of expert

judgement

What?

Representative of likely REs

Variable

Inside the limits where the GM will be grown

14

Sys et al. 1993 Land evaluation part III crop requirements

Based on Land suitability classification from FAO (1976)

HOW WE EVALUATE METEO CONDITIONS Classes: S1 subcat. 0 optimal areas S1 subcat. 1 near optimal areas S2 suboptimal areas S3 marginal areas N1 not suitable but susceptible to

correction N2 not suitable

15

HOW WE EVALUATE METEO CONDITIONS

Classes: S1 subcat. 0 optimal areas dark green S1 subcat. 1 near optimal areas light green S2 suboptimal areas yellow S3 marginal areas brown N1 not suitable but susceptible to correction grey N2 not suitable black

100% 0%

16

EXAMPLE OF METEOROLOGICAL CONDITIONS

Representative

Variable


Representative

Variable


17

HOW WE EVALUATE SOIL CONDITIONS

Classes: S1 subcat. 0 optimal areas S1 subcat. 1 near optimal areas S2 suboptimal areas S3 marginal areas N1 not suitable but susceptible to correction N2 not suitable

18

EXAMPLE OF SOIL CONDITIONS

Representative

Variable


Representative

Variable


19

HOW WE EVALUATE CROP MANAGEMENT

Field crops, usual planting and harvesting dates - USDA report, 2010.

Crop management should be representative of the likely REs: Planting and harvesting timing Treatments (e.g. herbicide, type and timing) Fertilization (amount and timing) Irrigation (amount and timing) Tillage (type and timing) Crop history

20

SELECTION OF REPRESENTATIVE SITES

Historical climatic conditions (average over 30 years)

21

REPRESENTATIVE CONDITIONS ON FIELD TRIALS

Meteorological conditions and crop management applied during the year(s) of field trials

22

Site representativeness is fundamental to drawn any conclusion on comparative assessment of GM plants

Conclusion on site representativeness takes into account a multi-factors assessment

Graphical tools could facilitate the expert judgements making decisions transparent and repeatable

Site representativeness requires expert judgments

CONSIDERATION ON SITE REPRESENTATIVENESS 1/2

23

Applicant might select appropriate sites, but end up with

no representative conditions (meteorological and/or crop

management during the field trials)

meteorological additional years as foreseen by the

agro/pheno GD

crop management additional field trials with

representative management

Meteorological and soil conditions figures will be published

soon with submission GD

CONSIDERATION ON SITE REPRESENTATIVENESS 2/2

24

THANK YOU FOR YOUR ATTENTION



EFSA Scientific Opinion Annual 2015 PMEM report on cultivation of maize MON810

Fernando Álvarez, GMO Unit 8th GMO Network meeting Parma 23 May 2017

2

Bt maize cultivation in the EU

0

20

40

60

80

100

120

140

160

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

20

15

SP SK RO PO PO GE FR CR

10

3xh

a

1.5% Total maize area

92%

Slovakia 104 ha

Portugal 8 017 ha

Czech Republic 997 ha

Romania 2.5 ha

Spain 107 749 ha

19 Opt outs

Bt-176 MON810

5 Countries in 2015

3

Since 1998

>100 varieties registered

~90% Bt maize in EU

~25% global adoption rate

Highest adoption rate in Ebro valley ''Hot spot area''

Bt maize cultivation in Spain

67% 81%

88%

>10000

>5000-10000

>1000-5000

>100-1000

>0-100

0

MON810 ha

Castañera et al. 2016.PLOS ONE 11(5): e0154200

Source: Avances

4

Lepidopteran pests of maize in the EU

Corn borers

Ostrinia nubilalis (ECB) Sesamia nonagrioides (MCB)

5

Annual PMEM reports maize MON810

From 2005, Monsanto submits to the EC annual PMEM reports according to Annex VII of Directive 2001/18/EC

From 2009, EC requests the GMO Panel to assess annual PMEM reports Scientific Opinions (SOs) on 2009-2015 PMEM reports (EFSA PMEM GD 2006, 2011)

To monitor changes in susceptibility to Cry1Ab for the assessment of the ‘high-dose/refuge’ strategy

‒ EuropaBio harmonised insect resistance management (IRM) plan

To identify unanticipated adverse effects caused by the cultivation of maize MON810 ‒ Farmer questionnaires (FQs) ‒ Literature searching &

assessment scientific publications

Case-Specific Monitoring

(CSM)

General Surveillance

(GS)

6

Dose-response Diet-overlay assays MIC50 and MIC90

Reference lab strain

1. Insect Resistance Monitoring Changes in baseline susceptibility Field sampling ECB and MCB from 3 areas Three sampling sites per area ~450 larvae per area Lab assays with F1 larvae

Case-specific monitoring

Insect Resistance Management Plan Based on the high-dose/refuge strategy EuropaBio, 2003 (MON810, Bt11, 1507)

Diagnostic dose Since 2013 MIC99 RR individuals

Maize MON 810

SS

SS SS

RR

RS

Non-Bt maize

Non-Bt maize

X

X

ECB collection 2004-2013

7

Case-specific monitoring

Insect Resistance Management Plan Based on the high-dose/refuge strategy EuropaBio, 2003 (MON810, Bt11, 1507)

2. Farmer Alert System Report unexpected damages caused

by target pests Stewardship activities Follow-up studies to confirm

resistance

Remedial plan in case of failure Procedures for unexpected damage / Confirmation of resistance / Remedial actions

Dose-response Diet-overlay assays MIC50 and MIC90

Reference lab strain

Diagnostic dose Since 2013 MIC99

RR individuals

Detection ≤3% Frequency

R alleles

1. Insect Resistance Monitoring Changes in baseline susceptibility Field sampling ECB and MCB from 3 areas Three sampling sites per area ~450 larvae per area Lab assays with F1 larvae

8

Case-specific monitoring – 2015

Crucial to delay resistance evolution

Requirements

• 20% non-Bt maize refuge (>5 ha)

• ≤750 m from Bt maize field

Compliance in Spain

• Through FQs

• 212 farmers in 2015

• 93% compliance

• Consent holder & MS to develop appropriate information systems of GMO cultivation

0 20 40 60 80 100

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

90

Implementation of non-Bt maize refuges

Compliance (%)

9


Field sampling of ECB/MCB populations Larvae (F0) collected from refuges and conventional maize fields

• ECB: Northeast and Central Iberia (3 sites at each area) • MCB: Northeast Iberia (3 sites)

Larvae reared in the lab and bioassays conducted with progeny (F1)

• ECB: 152-180 larvae reached adult stage (~40% field-collected) • MCB: 195 adults (37%) were used to obtain F1 larvae for assays

Insufficient # larvae sampled/represented in the bioassays as F1

10


Field sampling of ECB/MCB populations Larvae (F0) collected from refuges and conventional maize fields

• ECB: Northeast and Central Iberia (3 sites at each area) • MCB: Northeast Iberia (3 sites)

Larvae reared in the lab and bioassays conducted with progeny (F1)

• ECB: 152-180 larvae reached adult stage (~40% field-collected) • MCB: 195 adults (37%) were used to obtain F1 larvae for assays

Insufficient # larvae sampled/represented in the bioassays as F1

11


Concentration-response assays

0

1

2

3

4

5

6

7

8

9

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

North East Lab ref strain Resistance ratio

0

5

10

15

20

25

30

35

40

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

North East Lab ref strain Resistance Ratio

MIC

50

(9

5%

CI)

7-10 concentrations of purified Cry1Ab and F1 larvae (diet overlay assay)

Estimation MIC50 and MIC90 (with 95% CI) by Probit analysis

Calculation of Resistance Ratios (RR = MICfield population / MIClab ref strain)

12


Diagnostic-concentration assays Bioassay conducted since 2013 – Standalone from 2016 onwards?

Diagnostic concentration: MIC99 (derived from baseline data)

• ECB:48.2 ng Cry1Ab/cm2

• MCB: 28.2 ng Cry1Ab/cm2

No resistant individuals identified (~96 larvae tested/area/year)

Actual limit of R allele frequency that could be detected < 3% threshold Recommendation to increase sampling effort

Species Population Season

Moulting inhibition

(% ± SE)

ECB

North East Iberia 2013 100

2015 100

Central Iberia 2013 100

2015 100

MCB North East Iberia 2013 97 ± 2

2015 100

13


Farmer alert system

System allowing farmers to report complaints on product performance

Including unexpected crop damage caused by target pests

300 complaints received during 2015 season

None of the related to infestation by ECB/MCB

Useful complement to the info provided by the lab assays

Additional info needed to appraise usefulness:

• Appropriate communication mechanisms

• Fit-for-purpose educational programs

14

General surveillance – 2015

Farmer questionnaires 261 farmers surveyed in 2015: 212 from Spain and 49 from Portugal

Similar methodology compared to previous years Previous EFSA recommendations on sampling and reporting apply

The analysis of the 2015 FQs did not show any unanticipated adverse effects related to maize MON810 plants and their cultivation

2,627 questionnaires have been completed over 10 yrs. (2006-2015)

• EFSA previously recommended to perform stat analysis of pooled data • Monsanto’s intention is to publish such analysis in a peer-reviewed journal

15

General surveillance – 2015

Literature searching Lit. search to retrieve studies published btw. JUN 2015 – MAY 2016

(Slightly) Revised protocol based on:

• EFSA Guidance on systematic review methodology (EFSA, 2010) • Previous GMO Panel recommendations

Two databases: WoS Core Collection and CABI CAB Abstracts

Similar search strategy as previous years

18 relevant publications identified in 2015:

• 5 Food and feed safety • 13 ERA/Risk management

No new info that would invalidate previous FF and ERA conclusions on maize MON810

Recommendation to follow EFSA’s explanatory note on literature searching (EFSA, 2017)

FF/MC ERA/Risk management

150

73

PMEM 2009-2015

16

The data reported do not indicate any adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 during the 2015 growing season

The GMO Panel therefore concludes that the CSM and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maize MON 810

Some methodological limitations were identified:

Insect resistance monitoring activities – Do not provide

sufficient sensitivity for an early detection of potential resistance of target pests in the field

Farmer questionnaires – The sampling frame questionnaires

does not allow the assessment of the representativeness of the results

EFSA Scientific Opinion Annual PMEM maize MON810 – 2015

Conclusions

17

Sampling target pests

• To increase the sampling efforts (to achieve the recommended threshold)

• To focus in north-east Iberia (highest selection pressure)

‒ Annual sampling of both corn borers

‒ Three zones of ~10×10 km where adoption rate >60% for 3 years

Info on non-GM and maize MON 810 cropping areas at an appropriate scale should be made available by MS

Laboratory bioassays

• Measurement endpoints – Provide LC and MIC values

• Reference laboratory strain – Refreshment

• Confirmatory experiment with maize leaves – Negative control & add info

• Disclose raw data

Farmer alert system

• To provide additional info to appraise its usefulness and

Implementation of non-Bt refuges

• To increase level of compliance (especially in regions of high adoption)


Recommendations – CSM

18

Farmer questionnaires

• Previous recommendations on survey design and reporting

• To provide the pooled analysis from the surveys obtain over the last ten years

To confirm that no unintended effects caused by the cultivation of maize

MON 810 have been observed.

To evaluate the farmer questionnaire methodology for the detection of unintended effects

Literature search

• To follow the recommendations given in the EFSA’s explanatory note to the guidance on literature searching (EFSA, 2017)


Recommendations – GS

19

PMEM Working Group

Acknowledgements

EFSA GMO Unit Michele Ardizzone Yann Devos Antonio Fernández-Dumont

Salvatore Arpaia Barbara Manachini Antoine Méssean (chair) Jeremy Sweet

EFSA AMU Unit Marios Georgiadis Laura Martino

23-24 May 2017 – GMO RA Network MTG – Yann Devos (EFSA GMO Unit)

Teosinte in the EU – Are there any implications for the ERA of GM maize for cultivation?

2

3

Teosinte found in maize fields in the EU

Spain

Ebro Valley (Aragón)

Region of Cataluña (to a lesser extent)

Since 2009

France

Region of Poitou-Charentes

Since 1990

CONTEXT

4

EFSA was requested by EC to assess whether

“on the basis of the elements provided by this letter, the existing scientific literature and any other relevant information,

new evidence emerges which would change the conclusions and recommendations of the EFSA opinions on cultivation of genetically modified maizes MON810, Bt11 and 1507 and GA21”

Timeline

Mid June 2016 September 2016

MANDATE OF THE EUROPEAN COMMISSION (EC)

5

Materials

Documents supplied and translated by the European Commission (mostly grey literature)

Available relevant scientific literature

Methods

Narrative review of relevant scientific literature (non-systematic search)

Problem formulation exercise (pathways of harm)

Consultation of representatives of the Competent Authority of Spain

MATERIALS AND METHODS

6

In centres of origin

Teosinte is native to Mexico and Central America

Direct wild ancestor of maize

Many teosinte species and subspecies are rare and endangered, requiring conservation actions

Other teosinte species and subspecies are widely distributed, and occur in agricultural fields, where they are considered non-aggressive weeds

In some regions, teosinte is grown for forage/feed purposes

PROTECTION GOAL

7

Outside centres of origin

Teosinte is not indigenous, but has become naturalised/established in some countries

Teosinte does not represent an environmental entity of concern requiring protection

Instead, it is occasionally cultivated for its forage, or considered a weed

In infested agricultural fields, teosinte is subject to control and/or eradication measures

PROTECTION GOAL

8

Problem formulation exercise focusing on possible pathways to harm

EFSA explored whether plausible pathways to harm from the cultivation of maize MON810, Bt11, 1507 and GA21 can be hypothesised for situations where GM maize and teosinte would grow sympatrically, focusing on specific areas of risk typically considered in ERA of GM plants

APPROACH

9

Effects of vertical gene flow

Hybridisation potential (teosinte to maize >> maize to teosinte)

Altered persistence/invasiveness of GM maize × teosinte hybrids

Cross-pollination of maize by GM maize × teosinte hybrids

Interactions of GM maize × teosinte hybrids with

Other organisms (target and non-target)

The abiotic environment and biogeochemical processes

APPROACH

10

Pathways to harm

For each of the pathways considered, it is unlikely that environmental harm will be realised

Previous outputs

No information indicating the necessity to revise the previous ERA conclusions and risk management recommendations for maize MON810, Bt11, 1507 and GA21 made by the GMO Panel

CONCLUSION

11

Previous outputs

EFSA considers that the previous GMO Panel risk assessment conclusions and risk management recommendations on maize MON810, Bt11, 1507 and GA21 for cultivation remain valid and applicable

To ensure effective long-term management of teosinte and maize × teosinte hybrids that acquired glyphosate tolerance through vertical gene flow from maize GA21, and avoid exacerbating weed problems, EFSA recommends that integrated weed management reliant on multiple tactics is deployed when growing maize GA21 in association with GLY

CONCLUSION

12

Trtikova et al. (2017)

Teosinte in Europe – Searching for the origin of a novel weed. Scientific Reports, 7, 1560

Authors genotyped Spanish teosinte plants

Genetically distinct from teosinte taxa from Mexico and Nicaragua, and maize

Teosinte × maize hybrids

Origin unclear (EU or country of origin)

Study under assessment internally

NEW STUDY

13

ACKNOWLEDGEMENTS

Thank you for your attention

EFSA wishes to thank Yann Devos for the preparatory work on this scientific output, and Magdalena Ibáñez Ruiz, Antoine Messéan, Lucía Roda Ghisleri, Jeremy Sweet and Elisabeth Waigmann for the support provided to this scientific output

14



Subscribe to

Engage with careers


@efsa_eu

@plants_efsa

@methods_efsa


STAY CONNECTED!

Date post:	23-May-2020
Category:	Documents
Upload:	others
View:	1 times
Download:	0 times