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Scrutinizing GMO Risk Assessment Evaluating the practice of risk assessment of GM plants and food in the EU. SUBSTANTIAL EQUIVALENCE and NUTRITIONAL ASPECTS Petra Lehner Workshop, Vienna 10.12.2003. My Part. Detailed look on the practice of applying the concept of SE

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Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

Scrutinizing GMO Risk AssessmentEvaluating the practice of risk assessmentof GM plants and food in the EU

SUBSTANTIAL EQUIVALENCE and NUTRITIONAL ASPECTS

Petra Lehner

Workshop, Vienna 10.12.2003


My part

My Part

  • Detailed look on the practice of applying the concept of SE

    • What is done by the applicants to show SE

    • Similarities and differences

    • what can be done to make compositional comparisons more reliable and consistent

  • look on what is done with regard to nutrition evaluation

     Recommendations for further steps in order to keep the process of detailing and standardization of RA moving forward


Substantial equivalence

Substantial Equivalence

Expert Consultations convened by FAO/WHO and OECD have recommended that substantial equivalence be an important component in the safety assessment of foods derived from GMP

= establishing absolute safety but to consider whether the GMF is as safe as its traditional counterpart


Weaknesses se

Weaknesses SE

  • Compositional analyses as screening method for unintended effects of the genetic modification has its limitations

  • in particular regarding unknown anti-nutrients and natural toxins

    • “finer screening” - DNA analysis, messenger-RNA fingerprinting, protein fingerprinting, secondary metabolite profiling and in vitro toxicity testing


Safety assessment of gmf

Safety Assessment of GMF

  • directed by comparison GMF/CC

  • Identity, Source and Transformation Process

  • Recombinant DNA (stability, potential for gene transfer)

  • Protein Expression Product of the novel DNA (effects on function; potential toxicity; potential allergenicity)

  • Possible Secondary Effects from gene expression or disruption of host DNA or metabolic pathways, includingcompositionofcriticalmacro-, micro- and anti-nutrients, endogenous toxicants, allergensandphysiologically active substances

  • Composition

  • Effects of processing/cooking

  • Intake and dietary impact of the GMF


Efsa panel gmo

EFSA-Panel GMO

  • Elements to be considered in the safety assessment process

    • Molecular characteristics of the GMO taking into account the characteristics of the donor and recipient organisms

    • Potential environmental impact following a deliberate release

    • Compositional, nutritional, safety and agronomic characteristics

    • Potential toxicity and allergenicity of gene products and metabolites

    • Nutritional assessment of the GM food and feed


Nutritional evaluation

Nutritional Evaluation

  • Low-glutelin-Rice - unintended increase in levels of prolamins(not relevant for sake-brewing but in case of nutrition)

    • would not have been detected by standard composition analyses (total protein; AA-profiles)

  • „Golden Rice“ - unexpected accumulation of xanthophylls

    • would not have been apparent from standard analyses


Substantial equivalence in eu legislation

not explicitly detailed in EU legislation

„prominent“ role in Novel Food Regulation

Simple procedure (Art 5)

“Substantial Equivalence” on the basis of the scientific evidence available and generally recognized or on the basis of an opinion delivered by one of the competent bodies

Substantial Equivalence in EU-Legislation


Article 5 nf r

Article 5 NF-R

  • In the case of the foods or food ingredients referred to in Article 3 (4), the applicant shall notify the Commission of the placing on the market when he does so. Such notification shall be accompanied by the relevant details provided for in Article 3 (4).

    • composition

    • nutritional value

    • metabolism

    • intended use

    • level of undesirable substances contained therein


Article 6 nf r

Article 6 NF-R

  • The request referred to in Article 4 (1) (=application for placing on the market) shall contain the necessary information, including a copy of the studies which have been carried out and any other material which is available to demonstrate that the food or food ingredient complies with the criteria laid down in Article 3 .1


Evaluated dossiers

90/220 (11)

Rape Topas 19/2 (food-use included)

Maize Bt-11 (food-use included) – “twin”

Maize RR GA21 – “twin”

Cotton Bt-531

Cotton RR 1445

RR-Fodder beet A5/15

Potato EH92-527-1

Carnation 66

Carnation 959A

97/258 (7)

Rape RF1MS1, RF1MS2

Rape Topas 19/2

Rape GT73

Maize Bt-11

Maize T25

Maize MON 809

Maize MON 810

Evaluated Dossiers

NO ADDITIONAL DATA

NF-Application Rape Topas 19/2

and Maize Bt-11


General findings

General Findings

  • SE-Data widespread – no special chapter

    • composition data of raw products and/or processed products and/or information on processing (and exposition and/or consumption) are scattered throughout dossiers

  • Dossiers are not “stand alone”

  • Composition analyses: GLP not evident

  • Analyses of kernels – extended to processed products

    • Maize dossiers: only descriptions of processing procedures

    • Rape dossiers: Data of processed products (limited scale and set of parameters)


General findings 2

General Findings (2)

  • Barely Data on Consumption

  • Field trials/Sampling not described in detail

  • Only one dossier: isogenic counterpart

  • No herbicide-application in case of HR-GMP

  • No information on sample storage

  • Methods and Practice of Analysing rarely specified (Reps, Method-Errors, Detection-Limits etc)

  • Discontenting presentation of data


General findings 3

General Findings (3)

  • Solid statistical evaluation questionable

    • No continuous statistic evaluation

    • Missing information on methods/software/CI

      --> Cannot be concluded, that in each case the statistical evaluation is actually state of the art

  • Significant/remarkable compositional differences in all dossiers

    • Differences dismissed without adequate explanation or by arbitrarily citing literature ranges or „normal“ ranges

    • No rerun of analyses taking into account a broader spectrum of compounds

      • To get a better overview on compositional equivalence and

      • To better address the hazard of secondary/unintended effects


General findings 4

General Findings (4)

  • All dossiers evaluated by ACNFP/UK

  • Mandatory monitoring for all

    • Applicants are bound to monitor composition of seeds/kernels and/or oil over time

      • No concrete requirements

      • No additional information (all products were approved in UK at time of application)

  • All but one: supplemental information on MS-request


Findings compositional comparisons

Findings: Compositional Comparisons

  • lack of consistency in the data provided, even within the same plant species

  • Assertions of "no difference" not backed up by hard data

    • Quality of data arguable

      • Design of field trials / Replications / Conventional Counterpart

      • GLP / Double-testing / Reporting

      • Lacking plausibility that Compositional Data have been analysed in a statistically sound way

    • Comprehensiveness

      • Set of compounds not sufficient to properly assess equivalence of nutritional value

      • Set of compounds not sufficient to reliably detect secondary/unintended effects

REP


Conclusion

Conclusion

  • inconsistency and sometimes lack of useful data demonstrate the need for guidelines in order to harmonise and co-ordinate the basis requirement of data for comparison


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 11

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Base material: kernels

  • Field trials


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 111

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Description of Trials


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 112

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Sampling


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 113

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Analysing


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 114

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Macro-Compounds – „Proximates“


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 115

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Different Interpretation of „Proximates“

    • 3 Dossiers use expression „Proximates“

    • No consistency

  • OECD

    • Protein, Fat, Fibre, ADF, NDF, Ash, Carbohydrates

       NO Dossier contains data on all of these „proximates“

      NEED FOR HARMONISATION


Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

Prot

Fat

CH

Fibre

ADF

NDF

Ash

OECD

+

+

+

+

+

+

+

EuropaBio

+

+

-

-

-

-

+

T25

+

+

+

+

-

-

+

MON 809

+

+

+

-

-

-

+

MON 810 1994

+

+

+

-

-

-

+

MON 810 1995

+

+

+

-

+

+

+

Bt11

„Grain properties“ - P, F, Starch, Fibre

„Proximates“


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 116

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Micro-Compounds


Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

OECD

EuropaBio

T25

Bt11

MON 810

MON 809

AS (18)a % n.R.

+

+

-

+

+

FS (5)b % n.R.

+

+

-

+

+

Amino Acids and Fatty Acids

a) Ala, Arg, Asp, Cys, Iso, His, Glu, Gly, Leu, Lys, Met, Phe, Pro, Ser, Thr, Tyr, Try, Val;

b) Palmitic-, Stearic-, Oleic-, Linoleic-, Linolenicacid


Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

Vitamin mg/kg

OECD

EuroB

T25

Bt11

M810

M809

Retinolequivalent

+

-

-

-

-

-

Vit B1

+

+

-

+

-

-

Vit B2

+

+

-

+

-

-

Vit B6

+

-

-

-

-

-

Vit E

+

+

-

-

-

-

Folate total

+

+

-

+

-

-

Niacin (nicotinic acid)

+

-

-

+

-

-

Vitamins


Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

Mineral mg/100g

OECD

EuroB

T25

Bt11

M810

M809

Ca

+

+

-

-

-

-

K

+

+

-

-

-

-

Mg

+

+

-

+.

-

-

Na

+

+

-

-

-

-

P

+

+

-

-

-

-

Cu

+

-

-

+

-

-

Fe

+

-

-

-

-

-

Se

+

-

-

-

-

-

Zn

+

-

-

+

-

-

Minerals


Scrutinizing gmo risk assessment evaluating the practice of risk assessment of gm plants and food in the eu

Compound

OECD

EuroB

T25

Bt11

M810

M809

Phytic Acid % TG

+

+

-

-

-

-

Raffinose % n.k..

+

-

-

-

-

Furfural ppm

+

-

-

-

-

Ferulic Acid % n.k..

+

-

-

-

-

-

p-Coumaric Acid n.k.

+

-

-

-

-

-

Other Compounds


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 117

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Statistics


Maize compositional comparisons hr t25 ir mon810 hr ir mon809 hr ir bt 118

Maize: Compositional Comparisons( HR T25, IR MON810, HR/IR MON809; HR/IR Bt-11)

  • Processed Products – Composition Analyses

    !!! In OECD-ConsDoc the Composition of different processed maize-products is mentioned (oil, grit, flakes, meal, starch)


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