Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize: report
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| Main Authors: | , , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Wien
2007
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| Series: | Forschungsberichte der Sektion IV / Bundesministerium für Gesundheit, Familie und Jugend, Sektion IV
2007,4 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Zsfassung in dt. Sprache |
| Physical Description: | 31 S. |
| ISBN: | 9783902611079 |
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MARC
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| 245 | 1 | 0 | |a Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize |b report |c Michael Eckerstorfer ; Andreas Heissenberger ; Helmut Gaugitsch |
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| _version_ | 1804137548159647744 |
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| adam_text | IMAGE 1
REPORT
SUPPLEMENTARY RISK ASSESSMENT FOR GM MAIZE MON 810 WITH REGARD TO THE
CONCLUSIONS OF THE WTOPANEL IN THE CASE *EC BIOTECH ON AUSTRIAN
SAFEGUARD MEASURES FOR GM MAIZE
FORSCHUNGSBERICHTE DER SEKTION IV
BAND 4/2007
IMAGE 2
REPORT
SUPPLEMENTARY RISK ASSESSMENT FOR GM MAIZE MON 810 WITH REGARD TO THE
CONCLUSIONS OF THE WTOPANEL IN THE CASE *EC BIOTECH ON AUSTRIAN
SAFEGUARD MEASURES FOR GM MAIZE
FORSCHUNGSBERICHTE DER SEKTION IV
BAND 4/2007
IMAGE 3
IMPRESSUM:
HERAUSGEBER, MEDIENINHABER UND HERSTELLER: BUNDESMINISTERIUM FUER
GESUNDHEIT, FAMILIE UND JUGEND, SEKTION IV RADETZKYSTRASSE 2, 1031 WIEN
FUER DEN INHALT VERANTWORTLICH: BL MAG. ULRICH HERZOG
ERSCHEINUNGSTERMIN : DEZEMBER 2007
AUTOREN: DR. MICHAEL ECKERSTORFER DR. ANDREAS HEISSENBERGER DR. HELMUT
GAUGITSCH
DRUCK: KOPIERSTELLE DES BMGFJ, RADETZKYSTRASSE 2, 1031 WIEN
BESTELLMOEGLICHKEITEN: TELEFON: +43-1/711 00-4700 DW FAX: +43-1/715 58 30
E-MAIL: BROSCHUERENSERVICE.BMGFJ@BMGFJ.GV.AT INTERNET:
HTTP://WWW.BMGFJ.GV.AT
ISBN 978-3-902611-07-9
DIESE STUDIE/BROSCHUERE IST KOSTENLOS BEIM BUNDESMINISTERIUM FUER
GESUNDHEIT, FAMILIE UND JUGEND, RADETZKYSTRASSE 2, 1031 WIEN, ERHAELTLICH.
IMAGE 4
REPORT
SUPPLEMENTARY RISK ASSESSMENT
FOR GM MAIZE MON 810 WITH REGARD
TO THE CONCLUSIONS OF THE WTO-PANEL IN
THE CASE *EC BIOTECH
ON AUSTRIAN SAFEGUARD MEASURES FOR
GM MAIZE
MICHAEL ECKERSTORFER
ANDREAS HEISSENBERGER
HELMUT GAUGITSCH
VIENNA, 20 NOVEMBER 2007
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CONTENT
CONTENT................................................................................................................
2
SUMMARY
.............................................................................................................
3
ZUSAMMENFASSUNG
................................................................................................
5
INTRODUCTION..........................................................................................................
7
HISTORICAL
OVERVIEW................................................................................................
7
ARGUMENTS TO SUPPORT THE AUSTRIAN POSITION
.............................................................. 9
INSUFFICIENT SCIENTIFIC DATA
....................................................................................
9
THE AUSTRIAN ARGUMENTS
...................................................................................
9
THE SCP STATEMENTS
........................................................................................10
THE EFSA
OPINION............................................................................................10
ARGUMENTS BY THE EUROPEAN COMMISSION
...........................................................11
THE OPINION OF AN ADVISOR TO THE WTO
PANEL........................................................12
CONCLUSIONS....................................................................................................12
REMARKS WITH REGARD TO MAIZE
T25....................................................................13
COMPETING RISK
ASSESSMENT................................................................................14
1. INFORMATION ON ANY TOXIC, ALLERGENIC OR OTHER HARMFUL EFFECTS ON
HUMAN OR ANIMAL HEALTH ARISING FROM THE GM
FOOD/FEED.................................................................14
1.1 COMPARATIVE ASSESSMENT
(D.7.1).................................................................14
1.2 TOXICOLOGY
(D.7.8).....................................................................................15
1.3. ALLERGENICITY (D.7.9)
.................................................................................15
1.4. MAIZE T25 - HEALTH
ASPECTS........................................................................16
2. POTENTIAL CHANGES IN THE INTERACTIONS OF THE GM PLANT WITH THE BIOTIC
ENVIRONMENT RESULTING FROM THE GENETIC
MODIFICATION..............................................................16
2.1 POTENTIAL FOR GENE TRANSFER
(D.9.3)...............................................................17
2.2 INTERACTIONS BETWEEN THE GM PLANT AND TARGET ORGANISMS (D.9.4)
....................18 2.3 INTERACTIONS OF THE GM PLANT WITH NON-TARGET
ORGANISMS (D.9.5) ......................19 3. ASSESSMENT OF ECONOMIC
CONSEQUENCES DUE TO OUTCROSSING AND ADVENTITIOUS
PRESENCE........................................................................................................23
4. ENVIRONMENTAL MONITORING
PLAN......................................................................25
4.1 GENERAL ASPECTS (D
10.1)............................................................................25
4.2 CASE-SPECIFIC GM PLANT MONITORING
(D.10.3)..................................................25
4.3 GENERAL SURVEILLANCE OF THE IMPACT OF THE GM PLANT
(D.10.4)...........................26
REFERENCES...........................................................................................................26
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SUMMARY
THIS REPORT AIMS TO SUMMARIZE THE AUSTRIAN ARGUMENTS AS A REACTION TO
THE RULING OF THE WTO PANEL ESTABLISHED TO EXAMINE THE DISPUTE CASE
EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS . PART OF THE ALLEGED MEASURES WERE THE AUSTRIAN
SAFEGUARD CLAUSES WHICH PROHIBIT THE IMPORT AND USE OF THE GENETICALLY
MODIFIED MAIZE LINES MON810 AND T25. THIS REPORT THEREFORE FULFILS THE
WTO REQUIREMENTS TO BASE ANY MEASURES ON A RISK ASSESSMENT IN LINE WITH
SPS PROVISIONS AND ACCORDING TO GUIDANCE BY INTERNATIONAL STANDARD
SETTING BODIES.
THE REPORT IS STRUCTURED IN TWO MAIN PARTS: 1) EVIDENCE THAT THE
AVAILABLE DATA WERE INSUFFICIENT AND DID NOT ALLOW A COMPREHENSIVE
RISK-ASSESSMENT. 2) A RISK ASSESSMENT IN ORDER TO SUPPLEMENT THE
AUSTRIAN ARGUMENTATION AND TO FULFIL
THE REQUIREMENTS OF THE SPS AGREEMENT.
THIS REPORT SHOWS THAT THE OPINION OF AUSTRIA WITH RESPECT TO THE LACK
OF DATA WAS SUPPORTED AT LEAST PARTLY BY THE SCIENTIFIC COMMITTEE ON
PLANTS, THE EUROPEAN COMMISSION AND ONE OF THE EXPERTS CHOSEN BY THE WTO
PANEL TO PROVIDE THEM WITH SCIENTIFIC INFORMATION REGARDING THE DISPUTE
CASE.
THE RISK ASSESSMENT FOR MAIZE MON810 INCLUDED IN THIS REPORT EXAMINES
POSSIBLE EFFECTS ON TARGET AND NON-TARGET ORGANISMS AS WELL AS THE
POTENTIAL FOR GENE TRANSFER AND OTHER RELEVANT RISK ASSESSMENT
PARAMETERS.
WITH REGARD TO GM MAIZE MON810 THE RESULTS OF THE ASSESSMENT OF
INFORMATION PROVIDED BY THE NOTIFIER FOR MON810 AND RECENT SCIENTIFIC
INFORMATION WERE AS FOLLOWS:
O THE CONCLUSIONS DRAWN BY THE NOTIFIER WITH REGARD TO OUT-CROSSING AND
GENETRANSFER ARE BASED ON A BEST CASE SCENARIO, RATHER THAN TAKING
REALISTIC DATA AND THE HIGHLY VARIABLE RESULTS FROM DIFFERENT SCIENTIFIC
PUBLICATIONS INTO ACCOUNT.
O THE INSECT RESISTANCE MANAGEMENT PLAN IS INSUFFICIENT BECAUSE THERE IS
NO INFORMATION ON BASELINE DATA, A LACK OF INFORMATION REGARDING THE
IMPLEMENTATION AND A QUESTIONABLE ASSUMPTION WITH REGARD TO THE ADOPTION
SPEED OF GM MAIZE MON810 IN THE EUROPEAN UNION, WHICH WAS ESTIMATED TO
BE UNREALISTICALLY LOW.
O IT IS CLEARLY SHOWN THAT THERE IS A RISK TO NON-TARGET ORGANISMS. THIS
CONCLUSION IS BASED ON THE SCIENTIFIC LITERATURE AND DATA RELEVANT FOR
THE AUSTRIAN SITUATION, LIKE POPULATION DENSITIES OF LEPIDOPTERA IN
AGRICULTURAL ENVIRONMENTS, INCLUDING MAIZE FIELDS, AND THEIR
CLASSIFICATION AS ENDANGERED SPECIES . AS IT HAS BEEN SHOWN THAT
BT-TOXINS ALSO AFFECT NON-TARGET LEPIDOPTERAN SPECIES, IT IS LIKELY THAT
THE USE OF BTPLANTS WILL NEGATIVELY AFFECT POPULATIONS OF LEPIDOPTERA
LIVING IN AGRICULTURAL ENVIRONMENTS. AQUATIC NON-TARGET ORGANISMS, LIKE
TRICHOPTERA ARE ALSO LIKELY TO BE NEGATIVELY AFFECTED, ACCORDING TO NEW
SCIENTIFIC RESULTS.
O THE ASSUMPTIONS MADE BY THE APPLICANT CONCERNING TOXICOLOGICAL AND
ALLERGENIC PROPERTIES OF MON810 MAIZE ARE BASED ON ACUTE TOXICITY
STUDIES USING ISOLATED, BACTERIAL DERIVED PROTEINS, AS WELL AS HOMOLOGY
AND IN-VITRO DIGESTIBILITY STUDIES. THIS CANNOT BE CONSIDERED SUFFICIENT
AS THERE MAY BE STRUCTURAL DIFFERENCES BETWEEN PLANT- AND
BACTERIA-DERIVED PROTEINS; ANY CHRONIC AD SUB-CHRONIC EFFECTS CANNOT BE
ASSESSED BY THE APPROACH USED.
O THE SET OF PARAMETERS ASSESSED FOR COMPOSITIONAL ANALYSIS IS VERY
NARROW AND DOES NOT FOLLOW INTERNATIONAL GUIDELINES. EVEN THE RESULTS
SHOWING SIGNIFICANT DIFFERENCES TO NON-GM-PLANTS DID NOT LEAD TO FURTHER
INVESTIGATION.
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THE RISK ASSESSMENT FOR GM MAIZE T25 IS ALSO ADDRESSED, BUT IN A LESS
DETAILED MANNER. NEVERTHELESS IT CAN BE CONCLUDED THAT THE RISK
ASSESSMENT PROVIDED BY THE APPLICANT DOES NOT TAKE IN TO ACCOUNT ALL
RELEVANT ISSUES ACCORDING TO THE STATE-OF-THE-ART OF SCIENTIFIC
KNOWLEDGE.
IN ADDITION TO THE STANDARD RISK ASSESSMENT PARAMETERS AN ESTIMATION ON
THE POSSIBLE ECONOMIC CONSEQUENCES FOR ORGANIC AND CONVENTIONAL FARMERS
IS GIVEN. THIS ASSESSMENT IS IN LINE WITH THE ISPM-GUIDANCE BY THE
STANDARD SETTING BODY IPPC WHICH IS RECOGNIZED BY THE WTO. A LIKELY
DECREASE IN THE INCOME OF ORGANIC AND CONVENTIONAL FARMERS IS CAUSED BY
OUT-CROSSING FROM GM-MAIZE FIELDS AND THE CONSEQUENTIALLY DECREASED
VALUE OF THEIR HARVEST.
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ZUSAMMENFASSUNG
DAS ZIEL DIESES BERICHTS IST, DIE OESTERREICHISCHEN ARGUMENTE IM WTO-FALL
EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS ZUSAMMEN ZU FASSEN. DIE OESTERREICHISCHEN
SCHUTZKLAUSELN, MIT DENEN DER IMPORT UND DIE ANWENDUNG DER GENTECHNISCH
VERAENDERTEN MAISLINIEN MON810 UND T25 VERBOTEN WIRD, WAREN TEIL DER
BEKLAGTEN EU-MASSNAHMEN IM GENANNTEN STREITFALL. DIESER BERICHT ERFUELLT
DIE WTO KRITERIEN HINSICHTLICH DER FORDERUNG, DASS DIESE MASSNAHMEN AUF
EINER RISIKOABSCHAETZUNG BASIEREN MUESSEN, DIE DEM SPS ABKOMMEN ENTSPRICHT
UND NACH RICHTLINIEN VON INTERNATIONALEN STANDARDISIERUNGSORGANISATIONEN
DURCHGEFUEHRT WURDE.
DIESER BERICHT IST IN ZWEI THEMATISCHE BEREICHE GETEILT: 1. EINE
ARGUMENTATION, DASS DIE ZUR VERFUEGUNG STEHENDEN DATEN NICHT AUSREICHEND
WAREN, UM EINE UMFASSENDE RISIKOABSCHAETZUNG DURCHFUEHREN ZU KOENNEN. 2.
EINE ERGAENZENDE RISIKOABSCHAETZUNG UM DIE OESTERREICHISCHEN ARGUMENTE ZU
VERVOLLSTAENDIGEN UND DIE ANFORDERUNGEN NACH DEM SPS ABKOMMEN ZU
ERFUELLEN.
DIESER BERICHT ZEIGT, DASS DIE MEINUNG OESTERREICHS IN BEZUG AUF DAS
FEHLEN VON DATEN ZUR RISIKOABSCHAETZUNG ZUMINDEST TEILWEISE VOM
WISSENSCHAFTLICHEN KOMITEE FUER PFLANZEN DER EU, DER EUROPAEISCHEN
KOMMISSION UND EINEM DER WISSENSCHAFTLICHEN EXPERTEN, DIE VOM WTO-PANEL
ZU DESSEN UNTERSTUETZUNG HERANGEZOGEN WURDEN, GETEILT WIRD.
DIE IN DIESEM BERICHT VORGELEGTE RISIKOABSCHAETZUNG FUER MON810 MAIS
BEHANDELT MOEGLICHE EFFEKTE AUF ZIEL- UND NICHT-ZIELORGANISMEN SOWIE
MOEGLICHEN GENTRANSFER UND ANDERE RELEVANTE PARAMETER DER
RISIKOABSCHAETZUNG.
FUER MON810 KANN MIT BEZUG AUF DIE VOM ANTRAGSTELLER ZUR VERFUEGUNG
GESTELLTEN INFORMATIONEN UND NEUERE WISSENSCHAFTLICHE ERKENNTNISSE
FOLGENDES FESTGESTELLT WERDEN:
O DIE SCHLUSSFOLGERUNGEN DES ANTRAGSTELLERS IN BEZUG AUF AUSKREUZUNG UND
GENTRANSFER BERUHEN AUF EINEM *BEST CASE -SZENARIO, UND BASIEREN NICHT
AUF REALISTISCHEN DATEN UND DEN SEHR VARIABLEN RESULTATEN AUS DEN
VERFUEGBAREN WISSENSCHAFTLICHEN PUBLIKATIONEN.
O DER RESISTENZMANAGEMENTPLAN FUER DEN MAISZUENSLER IST UNZUREICHEND DA
KEINE ANGABE VON BASISDATEN ERFOLGTE, DIE INFORMATION BEZUEGLICH DER
UMSETZUNG DIESES PLANS UNZUREICHEND IST UND EINE UNREALISTISCHE, D.H.
VIEL ZU NIEDRIGE, ANNAHME BEZUEGLICH DER GESCHWINDIGKEIT DER EINFUEHRUNG
VON MON810 IN DER EU GETROFFEN WURDE.
O ES KONNTE KLAR GEZEIGT WERDEN, DASS EIN RISIKO FUER
NICHT-ZIELORGANISMEN BESTEHT. DIESES ERGEBNIS BERUHT AUF
WISSENSCHAFTLICHER LITERATUR UND FUER OESTERREICH RELEVANTE DATEN, WIE
Z.B. POPULATIONSDICHTEN VON LEPIDOPTEREN (SCHMETTERLINGEN) IN
LANDWIRTSCHAFTLICHEN OEKOSYSTEMEN UND MAISFELDERN SOWIE DEREN
GEFAEHRDUNGSKLASSIFIZIERUNG. DA GEZEIGT WURDE, DASS BT-TOXINE AUCH
EFFEKTE AUF NICHTZIELLEPIDOPTEREN HABEN, IST ES WAHRSCHEINLICH, DASS
LEPIDOPTERENPOPULATIONEN IN LANDWIRTSCHAFTLICHEN OEKOSYSTEMEN NEGATIV
BEEINFLUSST WERDEN. NACH NEUESTEN WISSENSCHAFTLICHEN ERKENNTNISSEN
KOENNEN AUCH AQUATISCHE NICHT-ZIELORGANISMEN, WIE TRICHOPTEREN
(KOECHERFLIEGEN) DURCH BT-TOXINE GESCHAEDIGT WERDEN.
O DIE SCHLUSSFOLGERUNGEN DES ANTRAGSTELLERS HINSICHTLICH DER TOXISCHEN
UND ALLERGENEN EIGENSCHAFTEN VON MON810 MAIS BASIEREN AUF
AKUT-TOXIZITAETSTESTS, DIE MIT AUS BAKTERIEN GEWONNENEM ISOLIERTEN
PROTEIN DURCHGEFUEHRT WURDEN, SOWIE AUF HOMOLOGIESTUDIEN UND IN-VITRO
ABBAUSTUDIEN. DIES KANN NICHT ALS AUSREICHEND ANGESEHEN WERDEN, DA SICH
DAS BAKTERIELLE PROTEIN MOEGLICHERWEISE VOM PFLANZLICHEN UNTERSCHEIDET
UND DURCH DEN VERSUCHSANSATZ CHRONISCHE ODER SUBCHRONISCHE EFFEKTE NICHT
ERFASST WERDEN.
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O DIE ANZAHL DER PARAMETER DIE ZUR UNTERSUCHUNG DER INHALTSSTOFFE
HERANGEZOGEN WURDEN IST NICHT AUSREICHEND UND ENTSPRICHT NICHT DEN
INTERNATIONALEN RICHTLINIEN. AUSSERDEM WURDEN SELBST BEI RESULTATEN DIE
SIGNIFIKANTE UNTERSCHIEDE ZU KONVENTIONELLEN PFLANZEN ZEIGTEN, KEINE
WEITEREN UNTERSUCHUNGEN DURCHGEFUEHRT.
DER GENTECHNISCH VERAENDERTE MAIS T25 WIRD EBENFALLS, ABER WENIGER
DETAILLIERT, BEHANDELT. TROTZDEM KANN FESTGESTELLT WERDEN, DASS DIE VOM
ANTRAGSTELLER VORGELEGTE RISIKOABSCHAETZUNG NICHT DEM STAND DER
WISSENSCHAFT UND TECHNIK ENTSPRICHT.
ZUSAETZLICH ZU DEN STANDARDPARAMETERN DER RISIKOABSCHAETZUNG WURDEN AUCH
MOEGLICHE OEKONOMISCHE AUSWIRKUNGEN AUF DIE BIOLOGISCHE UND KONVENTIONELLE
LANDWIRTSCHAFT ABGESCHAETZT. DIESE ABSCHAETZUNG ENTSPRICHT DEN ISPM
RICHTLINIEN DER IPPC, EINEM VON DER WTO ANERKANNTEN STANDARD. SEHR
WAHRSCHEINLICH WUERDE DAS EINKOMMEN VON BIOLOGISCHEN UND KONVENTIONELL
WIRTSCHAFTENDEN LANDWIRTEN AUFGRUND VON AUSKREUZUNG UND DER DAMIT
VERBUNDENEN WERTMINDERUNG IHRER ERNTE SINKEN.
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INTRODUCTION
IN SEPTEMBER 2006 THE WTO-PANEL, WHICH WAS ESTABLISHED TO SETTLE THE
DISPUTE CASE EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND
MARKETING OF BIOTECH PRODUCTS BASED ON A COMPLAINT BY THE USA, CANADA
AND ARGENTINA CONCERNING THE AUTHORIZATION OF GMOS AND SEVERAL NATIONAL
SAFEGUARD MEASURES BY EU-MEMBER STATES, PUBLISHED A FINAL REPORT (WTO
2006). IN THIS REPORT IT WAS STATED THAT SOME OF THE ALLEGED MEASURES,
LIKE THE DE FACTO MORATORIUM DO NO LONGER EXIST, WHEREAS OTHER
MEASURES, LIKE THE NATIONAL SAFEGUARD CLAUSES, ARE NOT IN LINE WITH THE
REQUIREMENTS LAID DOWN IN THE SPS AGREEMENT.
AFTER CHANGES IN EU AUTHORIZATION PROCEDURE AND THE WITHDRAWAL OF
SEVERAL PRODUCT NOTIFICATIONS AS WELL AS NATIONAL BANS, THE AUSTRIAN
SAFEGUARD CLAUSES REGARDING THE GENETICALLY MODIFIED MAIZE LINES MON810
AND T25 ARE THE ONLY ALLEGED MEASURES STILL IN PLACE.
CONCERNING THE NATIONAL SAFEGUARD MEASURES THE WTO PANEL RECOMMENDED
THAT THESE MEASURES ARE ALSO TO BE BROUGHT INTO CONSISTENCY WITH WTO
AGREEMENTS EITHER BY LIFTING THEM (AS NATIONAL MEASURES OR THROUGH
INVOLVEMENT OF THE EUROPEAN COMMUNITIES), OR BY PROVIDING REVISED RISK
ASSESSMENTS FOR THESE PRODUCTS THAT ARE IN LINE WITH THE SPS PROVISIONS.
IN OCTOBER 2006 THE FEDERAL MINISTRY FOR HEALTH AND WOMEN (NOW FEDERAL
MINISTRY FOR HEALTH, FAMILY AND YOUTH) ALREADY PUBLISHED AN ANALYSIS OF
THE WTO REPORT (ECKERSTORFER ET AL. 2006), WHICH ADDRESSED A NUMBER OF
OPEN QUESTIONS REGARDING THE REASONING OF THE WTO PANEL, SUCH AS
INADEQUACIES OF THE FINAL REPORT OF THE WTO PANEL IN ADDRESSING THE
SUBSTANTIVE JUSTIFICATION OF THE CONCERNS LEADING TO THE ADOPTION OF THE
AUSTRIAN SAFEGUARD MEASURES, THE FAILURE OF THE WTO PANEL TO CONSIDER
INADEQUACIES IN THE RISK ASSESSMENTS BY
THE SCIENTIFIC COMMITTEE ON PLANTS (SCP), WHILE REGARDING THE OPINIONS
OF THE SCP AS FORMAL EVIDENCE THAT SUFFICIENT SCIENTIFIC INFORMATION WAS
AVAILABLE, NOT CONSIDERING UNCERTAINTIES WITH REGARD TO THE LONG-TERM
ENVIRONMENTAL EFFECTS OF HERBICIDE-TOLERANT CROPS, THE EFFECTS OF GMOS
ON NON-TARGET ORGANISMS AND THE
INADEQUACIES OF BT-RESISTANCE MANAGEMENT AND MONITORING DESIGNS, THE
FAILURE OF THE WTO PANEL TO TAKE INTO ACCOUNT THAT REGIONAL ASPECTS WERE
NOT CONSIDERED SUFFICIENTLY.
THIS REPORT AIMS TO PRESENT MORE DETAIL AND - WHERE POSSIBLE - NEW
SCIENTIFIC DATA ON SOME OF THESE OPEN QUESTIONS AND TO SUPPORT THE
AUSTRIAN ARGUMENTATION BY
1) SUMMARIZING THE AUSTRIAN ARGUMENTATION REGARDING INSUFFICIENT
INFORMATION FOR CARRYING OUT A SATISFACTORY RISK ASSESSMENT (ACCORDING
TO ARTICLE 5.7. OF THE SPS AGREEMENT), AND
2) SUPPLEMENTING THE RISK ASSESSMENT CARRIED OUT BY AUSTRIA WITH
ADDITIONAL INFORMATION IN ORDER TO FULFIL THE REQUIREMENTS OF THE SPS
AGREEMENT (AS REFLECTED IN ART. 5.1. OF THE SPS AGREEMENT).
HISTORICAL OVERVIEW
IN MAY 2003 THE USA, CANADA AND ARGENTINA LAUNCHED A DISPUTE WITH THE
EUROPEAN COMMUNITIES ON COMPLAINTS THAT CERTAIN REGULATORY MEASURES OF
THE EUROPEAN COMMUNITIES CONCERNING BIOTECH PRODUCTS ARE NOT IN
CONFORMITY WITH WTO RULES. AS CONSULTATIONS BETWEEN THE COMPLAINING
PARTIES AND THE EC COULD NOT RESOLVE THESE ISSUES, THE THREE COMPLAINING
PARTIES REQUESTED THE ESTABLISHMENT OF A WTO PANEL TO FURTHER EXAMINE
THE MATTERS. FOLLOWING THOSE REQUESTS THE WTO DISPUTE SETTLEMENT BODY
(DSB)
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ESTABLISHED A PANEL TO DEAL WITH THE REQUESTS OF USA, CANADA AND
ARGENTINA IN AUGUST 2003. AFTER SEVERAL MEETINGS AND HEARINGS THE PANEL
DISTRIBUTED THE FINAL REPORT TO WTO MEMBER STATES IN SEPTEMBER 2006. THE
MAIN RESULTS OF THIS REPORT ARE BRIEFLY SUMMARIZED AS FOLLOWS:
MEASURE AT ISSUE WTO PANEL RULING
GENERAL SUSPENSION OF THE EC APPROVAL PROCESSES; GENERAL DE FACTO
MORATORIUM ON THE APPROVAL OF BIOTECH PRODUCTS.
A GENERAL DE FACTO MORATORIUM HAS BEEN APPLIED BY THE EC BETWEEN JUNE
1999 AND AUGUST 2003. THE MORATORIUM ITSELF IS NOT AN SPS MEASURE.
IT AFFECTED THE OPERATION AND APPLICATION OF
THE EC APPROVAL PROCEDURES. CURRENTLY NO INDICATIONS THAT
REPERCUSSIONS ARE PENDING FOR EC.
PRODUCT-SPECIFIC MEASURES ; FAILURE TO ADVANCE AND CONCLUDE THE EXISTING
APPROVAL PROCEDURES OF THE EC WITHOUT UNDUE DELAY ACCORDING TO SPS IN 27
CASES (ACCORDING TO DIR. 90/220/EEC OR DIR. 2001/18/EC AND REG. 258/97).
THE EC HAS BREACHED ITS OBLIGATIONS ON 24 (OUT OF 27) SPECIFIC
APPROVAL PROCEDURES. INCONSISTENCIES ONLY ACCORDING TO ANNEX C(1)(A)
AND ART.8 SPS ( UNDUE DELAY ). WHEN APPROVAL PROCEDURES ARE ADVANCED
WITHOUT FURTHER UNDUE DELAY, NO REPERCUSSIONS PENDING.
NATIONAL SAFEGUARD MEASURES BY EU MEMBER STATES; MARKETING OR IMPORT
BANS ON 9 GM-PRODUCTS BY 6 EU COUNTRIES (AUSTRIA, FRANCE, GERMANY,
GREECE, ITALY, LUXEMBOURG).
ALL SAFEGUARD MEASURES ARE NOT BASED ON A RISK ASSESSMENT AS REQUIRED
UNDER ART. 5.1 SPS AND NOT CONSISTENT WITH THE REQUIREMENTS OF ART. 5.7.
SPS.
BY MAINTAINING THESE MEASURES, THE EC HAS ACTED INCONSISTENTLY WITH
ITS OBLIGATIONS UNDER ART. 2.2 SPS.
EXISTENT MEASURES NEED TO BE BROUGHT IN CONFORMITY WITH SPS, OTHERWISE
REPERCUSSIONS ARE PENDING.
THE FIRST TWO ALLEGED MEASURES ARE NO LONGER VALID, AS THE DE-FACTO
MORATORIUM HAS BEEN TERMINATED IN SEPTEMBER 2004 AND ACTION AGAINST ANY
UNDUE DELAY HAS BEEN TAKEN BY THE EU BY ESTABLISHING A MORE
STREAMLINED AND CENTRALIZED AUTHORIZATION PROCEDURE ACCORDING TO
REGULATION (EC) 1829/03.
REGARDING THE NATIONAL SAFEGUARD MEASURES THE AUSTRIAN BANS OF GM MAIZE
MON810 AND T25 ARE THE ONLY BANS, WHICH HAVE BEEN CHALLENGED BY THE
COMPLAINING PARTIES AND WHICH ARE STILL IN PLACE. THEREFORE THESE BANS
REMAIN THE ONLY UNSOLVED ISSUE IN THE WTO-DISPUTE EC-BIOTECH .
THE EUROPEAN COMMISSION TRIED TWICE TO FORCE AUSTRIA TO LIFT ITS BAN BY
PROPOSING SUCH A MEASURE TO THE EUROPEAN COUNCIL (24 JUNE 2005 AND 18
DECEMBER 2006), BUT FAILED BECAUSE THESE PROPOSALS WERE REJECTED BY THE
COUNCIL WITH A QUALIFIED MAJORITY. A THIRD ATTEMPT BY THE EUROPEAN
COMMISSION TO PARTLY LIFT THE AUSTRIAN BANS, RESTRICTING THEM TO BANS
FOR CULTIVATION, COULD NEITHER REACH A QUALIFIED MAJORITY IN FAVOUR OR
AGAINST THE PROPOSAL AT THE COUNCIL ON 30 OCTOBER 2007. THEREFORE IT IS
NOW UP TO THE EUROPEAN COMMISSION TO DECIDE WHETHER THE BANS SHOULD BE
PARTLY LIFTED.
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ARGUMENTS TO SUPPORT THE AUSTRIAN POSITION
INSUFFICIENT SCIENTIFIC DATA ONE OF THE CRUCIAL QUESTIONS WHICH WAS
DISCUSSED DURING THE PANEL MEETINGS AND THE MEETINGS WITH THE
COMPLAINING PARTIES AND THE EC WAS:
IS THE SCIENTIFIC EVIDENCE INSUFFICIENT TO CONDUCT A RISK ASSESSMENT
ACCORDING TO ART. 5.1. OF THE SPS AGREEMENT?
AUSTRIA BASED ITS BANS ON THE LACK OF SCIENTIFIC INFORMATION REGARDING
ENVIRONMENTAL RISK ASSESSMENT, WHICH WAS BACKED BY SCIENTIFIC STUDIES
SHOWING THAT ADVERSE EFFECTS HAVE NOT BEEN CORRECTLY ASSESSED IN THE
INITIAL RISK ASSESSMENT. IN THE COURSE OF THE FOLLOWING YEARS AUSTRIA
PROVIDED EVEN MORE ARGUMENTS AND SCIENTIFIC EVIDENCE COVERING ALSO
HEALTH ASPECTS AS REQUESTED BY THE EUROPEAN COMMISSION. HOWEVER, THE
WTO-PANEL CONCLUDED THAT THERE WAS SUFFICIENT INFORMATION, BASED ON THE
FACT, THAT OTHERWISE THE EC WOULD NOT HAVE APPROVED THE RESPECTIVE GMOS
AND THAT THE SCIENTIFIC BODIES INVOLVED IN THE PROCESS, NAMELY THE
SCIENTIFIC COMMITTEE ON PLANTS (SCP) AND THE EFSA, WOULD NOT HAVE ISSUED
A POSITIVE OPINION.
THE FOLLOWING CHAPTER IDENTIFIES THE CONTRADICTIONS IN THIS
ARGUMENTATION AND WILL SUMMARIZE THE ARGUMENTS, WHY THERE IS STILL
INSUFFICIENT SCIENTIFIC INFORMATION AVAILABLE TO CONDUCT A PROPER RISK
ASSESSMENT.
THE AUSTRIAN ARGUMENTS AFTER CONSENT WAS GIVEN TO THE NOTIFICATION OF GM
MAIZE MON810 IN APRIL 1998 (COMMISSION DECISION 98/294/EC), THE AUSTRIAN
COMPETENT AUTHORITY DECIDED TO PROHIBIT THE PLACING ON THE MARKET OF GM
MAIZE LINE MON810 ON 10 JUNE 1999 AS A SAFEGUARD MEASURE ACCORDING TO
ARTICLE 16 OF DIRECTIVE 90/220/EEC. THE OBJECTION OF AUSTRIA WAS BASED
ON THE FACT THAT THE INFORMATION PROVIDED BY THE APPLICANT WAS NOT
DEEMED SUFFICIENT WITH REGARD TO THE FOLLOWING POINTS OF CONCERN:
A. POSSIBLE UNINTENDED EFFECTS OF THE BT TOXIN ON NON-TARGET INSECTS B.
UNCERTAINTY ABOUT THE EFFECTIVENESS OF THE REFUGE STRATEGY IN ORDER TO
PREVENT THE DEVELOPMENT OF BT RESISTANCE IN THE EUROPEAN CORN BORER. C.
EFFECTS OF OTHER BT PLANTS SUCH AS THE INCREASE OF SECONDARY PESTS AND
CONSEQUENTLY ADDITIONAL USE OF SYNTHETIC PLANT PROTECTION PRODUCTS. D.
UNCERTAINTY ABOUT THE SPECIFICITY OF BT PLANTS
IN A SUBSEQUENT COMMUNICATION TO THE COMMISSION DATED JANUARY 2004 (BMGF
2004A) AUSTRIA REITERATED ITS OBJECTIONS AND RAISED ADDITIONAL CONCERNS
WITH RESPECT TO ALLERGENIC PROPERTIES OF BT PROTEINS RELEVANT FOR GM
MAIZE MON810. FURTHERMORE, GENERAL SHORTCOMINGS IN ALLERGENICITY AND
TOXICITY ASSESSMENT UNDER DIRECTIVE 2001/18/EC AND UNDER THE NOVEL FOOD
REGULATION WERE EMPHASISED. ESPECIALLY, DIGESTIBILITY STUDIES USING
MICROBIAL TEST PROTEINS WERE NOT CONSIDERED APPROPRIATE BECAUSE POST
TRANSLATIONAL MODIFICATION COULD POSSIBLY AFFECT PROTEIN PROPERTIES OR
FUNCTION (DOLEZEL ET AL. 2007). IN ADDITION IT WAS POINTED OUT THAT THE
NUTRITIONAL ANALYSIS PRESENTED IN THE ORIGINAL DOSSIER OF MON810 DOES
NOT FULFIL THE REQUIREMENTS OF THE OECD (OECD 2002), AS SEVERAL
COMPOUNDS, LIKE MINERALS OR VITAMINS WERE NOT ASSESSED.
THE AUSTRIAN BAN FOR GM MAIZE MON810 WAS THEREFORE BASED
ON LACK OF INFORMATION ON ENVIRONMENTAL ISSUES, BECAUSE THEY WERE NOT
PROVIDED BY THE NOTIFIER OR ON SCIENTIFIC EVIDENCE, WHICH WAS
REFERRED TO BY AUSTRIA, BUT WAS NOT TAKEN INTO ACCOUNT WHEN GRANTING THE
CONSENT, AND ON HEALTH ISSUES, BECAUSE THE DATA PROVIDED IN THE
DOSSIER WERE EITHER INCOMPLETE
OR NOT OBTAINED BY USING ADEQUATE METHODS.
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THE SCP STATEMENTS IN ITS FIRST OPINION, WHICH WAS THE BASIS FOR THE
DECISION TO GRANT CONSENT FOR THE PLACING ON THE MARKET OF GM MAIZE
MON810, THE SCP STATED THAT THERE WAS NEITHER A RISK FOR THE ENVIRONMENT
NOR HUMAN OR ANIMAL HEALTH. IT CONSIDERED THE INFORMATION PROVIDED BY
THE APPLICANT AS SUFFICIENT. HOWEVER, THE COMMITTEE ALSO POINTED OUT
THAT THE OFTEN APPLIED IN VITRO METHODOLOGY USED TO STUDY THE SURVIVAL
OF BTK TOXIN CAN BE IMPROVED. IN PARTICULAR, THE USE OF THE ISOLATED
PROTEIN IN TOXICITY STUDIES DOES NOT ADEQUATELY MODEL DEGRADATION OF THE
SAME PROTEIN WHEN FED AS AN INTEGRAL COMPONENT OF THE DIET , BUT DID
NOT REQUIRE FURTHER STUDIES.
THE SECOND OPINION OF THE SCP OF 24 SEPTEMBER 1999, WHICH WAS PUBLISHED
AS A REACTION TO THE AUSTRIAN BAN, DID NOT CONSIDER ASPECTS OF HUMAN
HEALTH OR SUBSTANTIAL EQUIVALENCE. THIS WAS IN ACCORDANCE WITH THE SCOPE
OF THE AUSTRIAN SUBMISSION OF 1998, WHICH ONLY RAISED ENVIRONMENTAL
CONCERNS.
WITH REGARD TO THE ENVIRONMENTAL CONCERNS RAISED BY AUSTRIA THE SCP DID
NOT CONSIDER THEM AS JUSTIFIED BUT HOWEVER STATED THAT:
1. WITH RESPECT TO POSSIBLE UNINTENDED EFFECTS ON NON-TARGET INSECTS
RESULTS OF LABORATORY STUDIES WOULD BE DIFFICULT TO INTERPRET AND
EXTRAPOLATE TO FIELD CONDITIONS AND THAT SUCH INTERPRETATION MUST BE
VIEWED AGAINST THE COMPARATIVE RISK ASSESSMENT OF ALTERNATIVE SPRAY
APPLICATIONS OF INSECTICIDES, AND THAT FURTHER WORK WOULD BE NEEDED TO
INVESTIGATE AND VERIFY SUCH EFFECTS IN THE FIELD. 2. WITH RESPECT TO THE
LIMITED SPECIFICITY OF BT PLANTS THE COMMITTEE ADMITTED THAT
GM MAIZE HAS THE POTENTIAL TO BE TOXIC TO CERTAIN SPECIES OF LEPIDOPTERA
AND CONCLUDED THAT THIS ISSUE MUST BE DEALT WITH ON A SPECIES-TO-SPECIES
BASIS .
EVEN IF THE SCP COULD NOT SEE ANY RISK LINKED TO THE PLACING ON THE
MARKET OF MON810 IN ITS FIRST STATEMENT, IT IS HIGHLY IMPORTANT THAT IT
ADMITTED IN ITS REACTION TO THE AUSTRIAN BANS THAT THERE IS A NEED FOR
FURTHER INVESTIGATION OF NEGATIVE EFFECTS ON NON-TARGET ORGANISMS,
ADMITTING, IN OTHER WORDS, THAT THERE IS A LACK OF DATA WITH RESPECT TO
THE ASSESSMENT OF EFFECTS ON NON-TARGET ORGANISMS.
THE EFSA OPINION IN 2004 THE EFSA GMO PANEL RESPONDED TO A REQUEST FROM
THE EUROPEAN COMMISSION AND CONCLUDED THAT THE EVIDENCE PRESENTED BY
AUSTRIA CONTAINED NO NEW GENERIC OR LOCAL SCIENTIFIC INFORMATION ON THE
ENVIRONMENTAL IMPACTS OF THE SPECIFIED MAIZE. IN THE REVIEW OF THE
EVIDENCE PROVIDED BY AUSTRIA EFSA ONLY DISCUSSED EVIDENCE SUBMITTED TO
SUSTAIN AUSTRIA S ENVIRONMENTAL CONCERNS. THE PANEL DISMISSED THE
EVIDENCE PROVIDED BY AUSTRIA THAT CRITICALLY REVIEWS AND ASSESSES THE
VALIDITY OF TOXICITY ASSESSMENT, ALLERGENICITY ASSESSMENT AND THE
PRACTICE OF SUBSTANTIAL EQUIVALENCE IN A NUMBER OF DIRECTIVE 90/220/EEC
AND NOVEL FOOD DOSSIERS, INCLUDING GM MAIZE MON810 AND T25 MAIZE (SPOEK
ET AL. 2004).
IN 2006 A SECOND OPINION OF THE EFSA GMO PANEL, RELATED TO SEVERAL GM
CROPS SUBJECT TO SAFEGUARD MEASURES, WAS PUBLISHED, FOLLOWING A REQUEST
BY THE COUNCIL OF MINISTERS OF ENVIRONMENT. EFSA EXPLICITLY STATED THAT
IT DID NOT REASSESS THE DOSSIERS OF THE ORIGINAL APPLICATIONS, WHETHER
THEY WOULD COMPLY WITH THE MOST RECENT SAFETY REQUIREMENTS LAID DOWN IN
DIRECTIVE 2001/18/EC, REGULATION (EC) 1829/03 AND THE EFSA GUIDANCE
DOCUMENT, BUT FOCUSED ON THE ARGUMENTS PRESENTED BY THE MEMBER STATES TO
JUSTIFY THEIR SAFEGUARD MEASURES.
IN ITS OPINION EFSA DID NEITHER MENTION ANY NEW EVIDENCE PROVIDED BY
MEMBER STATES FOLLOWING ITS 2004 OPINION, NOR ANY NEW SCIENTIFIC
LITERATURE IN THE PUBLIC DOMAIN. THE PANEL HOWEVER REAFFIRMED ITS
CONCLUSIONS FOR THE PREVIOUS 2004 OPINION.
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ARGUMENTS BY THE EUROPEAN COMMISSION MATERIAL PROVIDED BY THE EUROPEAN
COMMISSION IN THE COURSE OF THE WTO DISPUTE SHOWS THAT THE COMMISSION IS
ACKNOWLEDGING IN SOME CASES THE LACK OF SUFFICIENT SCIENTIFIC
INFORMATION IN GMO RISK ASSESSMENT. IN THE FOLLOWING SOME EXAMPLES OF
THE COMMISSION S ARGUMENTS ARE PRESENTED (ALL TAKEN FROM WTO 2006). A
MORE DETAILED ANALYSIS IS GIVEN IN ECKERSTORFER ET AL. (2006).
AS A GENERAL OBSERVATION THE COMMISSION STATES THAT:
- SCIENTIFIC AND TECHNICAL KNOWLEDGE IS INCOMPLETE AND THAT THERE IS
LIMITED EXPERIENCE.
- THERE IS ABSENCE OF AGREED CRITERIA ON MANY ISSUES (IN SCIENTIFIC AND
REGULATORY CIRCLES), INCLUDING WITH RESPECT TO THE INFORMATION NECESSARY
TO PERFORM A RISK ASSESSMENT AND, ALSO, THE MANNER IN WHICH TO INTERPRET
THE RELEVANT DATA.
WITH RESPECT TO THE FUNDAMENTAL CRITICISM OF THE RELIANCE ON ACUTE
TOXICITY TESTING THE COMMISSION, STATED THAT
[C]ONCERNING THE RESULTS OF THE TOXICOLOGICAL ASSESSMENT OF THE
COMPANIES, IT MUST BE STATED THAT THE COMPREHENSIVE TOXICOLOGICAL RISK
ASSESSMENT AS DESCRIBED IN SPOEK ET AL. SHOULD BE CARRIED OUT. [*] THE
PROPOSED TESTS SHOULD BE PERFORMED BY THE NOTIFIER AND THE RESULTING
DATA PROVIDED IN ORDER TO GUARANTEE A HIGH LEVEL OF SAFETY AND PUBLIC
CONFIDENCE IN THE APPROACH TAKEN.
WITH REGARD TO WHOLE FOOD STUDIES:
WHOLE FOOD STUDIES ARE NECESSARY TO COMPLETE THE ASSESSMENT OF THE
SAFETY OF NEW FEEDS OR FOODS FOR THE FOLLOWING REASONS: THE
DETERMINATION OF THE NUTRIENTSTOXICANTS (SUBSTANTIAL EQUIVALENCE) CAN
NOT DETECT ALL UNINTENDED EFFECTS (PRODUCTS); THE LEVEL OF PROTEINS MAY
BE INCREASING SIGNIFICANTLY IN SUCCESSIVE PRODUCTS [*]
AND WITH REGARD TO THE USED TEST SUBSTANCE:
[T]OXICOLOGY OF THE NEWLY EXPRESSED PROTEINS IN THE GM PRODUCTS AT
STAKE, WAS OFTEN TESTED WITH SURROGATE PROTEINS (I.E. ISOLATED FROM
HETEROLOGOUS SYSTEMS, DIFFERENT FROM THE GM PLANT, SEE REVIEW BY FREESE
AND SCHUBERT (2004)), WITHOUT PROPER DEMONSTRATION OF BIOCHEMICAL,
STRUCTURAL, OR FUNCTIONAL EQUIVALENCE OF THE SURROGATE PROTEIN TO ITS
COUNTERPART (FOR INSTANCE AS REGARDS MUTATIONAL CHANGES, POST
TRANSLATIONAL MODIFICATIONS, OR OTHERS), AS RECOMMENDED IN PARAGRAPH 40
OF THE CODEX GUIDELINES. REMARKABLE HERE IS THE REFERENCE TO THE CODEX
ALIMENTARIUS GUIDELINES, AS THE CODEX ALIMENTARIUS COMMISSION IS ONE OF
THE STANDARD SETTING BODIES RECOGNIZED IN THE SPS AGREEMENT.
ALTHOUGH THIS DOES NOT MEAN, THAT THE EUROPEAN COMMISSION IS SUBSCRIBING
TO ALL THE ARGUMENTS BROUGHT UP BY AUSTRIA, IT SUPPORTS IN MANY WAYS THE
AUSTRIAN ARGUMENTS TO JUSTIFY ITS SAFEGUARD MEASURES, EVEN IF THE
EUROPEAN COMMISSION BY DOING SO CONTRADICTS THE SCP AND THE EFSA PANEL
ON GMOS.
MOST IMPORTANT IN THIS CONTEXT IS THAT THE EUROPEAN COMMISSION
RECOGNISES THAT THE AVAILABLE INFORMATION IS INCOMPLETE.
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THE OPINION OF AN ADVISOR TO THE WTO PANEL IN THE WTO REPORT A SMALL
GROUP OF SCIENTIFIC EXPERTS WERE PROVIDING SCIENTIFIC INPUT TO QUESTIONS
POSED BY THE PANEL ON VARIOUS ISSUES. THE EXPERTS ADVICE WAS PROVIDED
TO ASSIST THE PANEL IN THE SCIENTIFIC ASSESSMENTS, AND SHOULD NOT COVER
GENERAL OPINIONS ON THE SAFETY OF GMOS. EXPERT OPINIONS SHOULD BE
LIMITED TO SCIENTIFIC AND TECHNICAL ISSUES, WHEREAS THE TASK OF ANY
LEGAL ASSESSMENT REMAINED WITH THE PANEL.
DR. DAVE ANDOW, ONE OF THE SCIENTISTS FROM THIS GROUP OF EXPERTS,
SPECIFICALLY PROVIDED VALUABLE SCIENTIFIC EVIDENCE TO BE TAKEN INTO
ACCOUNT (WTO 2006, ANNEX H AND J). DR. ANDOW CONSIDERED IN DEPTH THE
INDIVIDUAL JUSTIFICATIONS PROVIDED BY AUSTRIA IN ITS PROHIBITION OF GM
MAIZE MON810. IN PARTICULAR HE PROVIDED INFORMATION, WHETHER THERE WAS
SUFFICIENT SCIENTIFIC EVIDENCE AVAILABLE TO AUSTRIA IN JUNE 1999 AND IN
AUGUST 2003 TO UNDERTAKE A MORE OBJECTIVE ASSESSMENT OF POTENTIAL RISKS
TO THE ENVIRONMENT FROM GM MAIZE MON810.
1. DR. ANDOW STATED THAT IN 2003 AUSTRIA COULD REASONABLY MAINTAIN THAT
THERE IS STILL INSUFFICIENT INFORMATION TO KNOW WHICH NON-TARGET
ORGANISMS MIGHT BE AT RISK AND THEREFORE AN OBJECTIVE RISK ASSESSMENT
WAS NOT POSSIBLE. HE EMPHASISED THAT NOT ALL OF THE NON-TARGET SPECIES
AT RISK CAUSED BY GM MAIZE MON810 HAD BEEN IDENTIFIED IN EUROPE. DR.
ANDOW COMMENTED ON THE FOLLOWING POINTS WHICH WERE NOT REFLECTED IN THE
SCP OPINION: FIRST ADDITIONAL ASSESSMENTS SHOULD HAVE BEEN CONDUCTED ON
LACEWINGS AND MONARCH BUTTERFLIES IN ORDER TO DETERMINE THE RELEVANCE IN
THE FIELD. THE AIM OF A TIERED RISK ASSESSMENT PROTOCOL IS TO EXPOSE
ORGANISMS TO CONCENTRATIONS HIGHER THAN CONSIDERED TYPICAL IN THE FIELD.
THEREFORE EXPERIMENTAL POSITIVES FROM LABORATORY STUDIES SHOULD UNDERGO
ADDITIONAL EVALUATIONS. BOTH LACEWINGS AND MONARCHS HAD BEEN ADVERSELY
AFFECTED BY THE CRY1AB TOXIN IN LABORATORY EXPERIMENTS. SECONDLY THE
SPECIFICITY OF THE CRY1AB TOXIN SEEMED TO BE BROADER THAN PREVIOUSLY
EXPECTED. 2. WITH RESPECT TO RISKS ON SOIL ORGANISMS DR. ANDOW DISCUSSED
SOME SCIENTIFIC
ASPECTS THAT WERE LEFT UNCONSIDERED BY THE SCP. FIRST THE ACTUAL RATES
AND DEGRADATION PROCESSES FOR LARGE PROTEINS IN SOILS ARE POORLY
UNDERSTOOD. SECOND, THE BT TOXIN LOAD IN MAIZE FIELDS CAN BE SUBSTANTIAL
WHICH MAKE LARGE-SCALE EFFECTS POSSIBLE. THIRD, IT IS KNOWN THAT THE BT
TOXIN IN THE SOIL CAN HAVE ADVERSE EFFECTS ON EARTHWORMS. 3. REFERRING
TO RESISTANCE RISK AND MANAGEMENT DR. ANDOW STATED THAT THE
FOLLOWING POINTS WERE NOT REFLECTED IN THE SCP OPINION. FIRST THE RATE
OF MARKET PENETRATION OF BT MAIZE HAD BEEN FASTER THAN PREDICTED IN THE
US WHICH CONTRADICTED THE PREDICTION OF THE SCP THAT MARKET PENETRATION
WOULD BE SLOW. SECONDLY RESISTANCE WOULD EVOLVE LOCALLY AND THEREFORE
REFUGES MUST BE AVAILABLE WHEREVER BT MAIZE IS LOCALLY USED AND REFUGES
ARE REQUIRED FROM THE BEGINNING OF BT PLANTING. RESISTANCE MANAGEMENT IS
THE RESPONSIBILITY OF EACH FARMER WHO USES BT MAIZE AND EACH FARMER
SHOULD BE REQUIRED TO IMPLEMENT MEASURES SUCH AS SETTING UP OF REFUGES.
IN SUMMARY DR. ANDOW, IN HIS CAPACITY AS SCIENTIFIC ADVISOR TO THE WTO
PANEL, SUPPORTED THE AUSTRIAN POINT OF VIEW, THAT THERE IS INSUFFICIENT
INFORMATION ESPECIALLY ON POSSIBLE NEGATIVE EFFECTS ON NON-TARGET
ORGANISMS, SOIL ORGANISMS AND THE QUESTION OF RESISTANCE RISK AND
MANAGEMENT.
CONCLUSIONS AUSTRIA STATED DURING THE AUTHORISATION PROCEDURE THAT THERE
WAS A LACK OF INFORMATION IN ORDER TO CARRY OUT AN ADEQUATE RISK
ASSESSMENT. SUBSEQUENTLY THE CONCERNS WERE RECONFIRMED WHEN JUSTIFYING
ITS SAFEGUARD MEASURES. BASED ON THESE ARGUMENTS THE IMPORT BANS WHERE
ISSUED. IN THE FOLLOWING PROCEDURE AUSTRIA EXTENDED ITS SCIENTIFIC
REASONING ALSO TO POSSIBLE NEGATIVE EFFECTS ON HUMAN HEALTH.
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THOUGH THE SCP COULD NOT IDENTIFY ANY RISK LINKED TO THE PLACING ON THE
MARKET OF GM MAIZE MON810 IT ALSO STATED (SECOND OPINION) THAT FURTHER
WORK IS NEEDED TO IDENTIFY ANY POSSIBLE EFFECTS ON NON TARGET ORGANISMS.
EFSA NEVER EXAMINED THE ORIGINAL APPLICATION. IT IS HIGHLY DOUBTFUL,
THAT THE INFORMATION INCLUDED IN THE ORIGINAL APPLICATION WOULD BE
SUFFICIENT TO FULFIL THE CRITERIA OF THE NEW AUTHORISATION PROCEDURE
ACCORDING TO REGULATION (EC) 1829/03 AND THE REQUIREMENTS OF THE EFSA
GUIDANCE DOCUMENT ON RISK ASSESSMENT (EFSA 2006).
MOST ARGUMENTS OF AUSTRIA WERE ACKNOWLEDGED BY THE EUROPEAN COMMISSION,
SUPPORTING THE VIEW THAT THE SCIENTIFIC INFORMATION IS INCOMPLETE. SOME
OF THE STATEMENTS BY THE EUROPEAN COMMISSION ARE IN CLEAR CONTRADICTION
TO SCP AND EFSA OPINIONS.
SOME OF THE ARGUMENTS ARE EVEN SUPPORTED, AND BACKED BY ADDITIONAL
SCIENTIFIC ARGUMENTS BY AT LEAST ONE OF THE SCIENTIFIC ADVISORS TO THE
WTO PANEL.
REVIEWING ALL THE STATEMENTS/OPINIONS DELIVERED BY THE DIFFERENT
SCIENTISTS AND THE EUROPEAN COMMISSION, IT IS CLEARLY SHOWN, THAT ALL OF
THEM, EXCEPT THE EFSA PANEL, WHICH DID NOT EXAMINE THE ORIGINAL
APPLICATION, CONFIRM THE AUSTRIAN VIEW THAT THE AVAILABLE INFORMATION IS
INSUFFICIENT OR INCOMPLETE OR THAT FURTHER WORK IS NEEDED, AND A
PROPER RISK ASSESSMENT COULD NOT HAVE BEEN CARRIED OUT.
THIS BACKS THE AUSTRIAN POSITION THAT THE RISK ASSESSMENT CARRIED OUT
BASED ON THE INFORMATION PROVIDED IN THE ORIGINAL APPLICATION DOES NOT
FULFIL THE CRITERIA OF THE CURRENT EUROPEAN LEGISLATION AND THE SPS
AGREEMENT.
REMARKS WITH REGARD TO MAIZE T25 THIS REPORT FOCUSES ON THE GENETICALLY
MODIFIED (GM) MAIZE MON810 BECAUSE OF ITS HIGHER RELEVANCE CONCERNING
CULTIVATION IN AUSTRIA COMPARED TO GM MAIZE T25. MON810 VARIETIES HAVE
BEEN AUTHORIZED FOR PLANTING IN THE EU AND GM MAIZE MON810 IS ALREADY
USED BY FARMERS IN SEVERAL EUROPEAN COUNTRIES.
ALTHOUGH MANY ISSUES WHICH WERE DISCUSSED ABOVE FOR GM MAIZE MON810 ARE
ALSO VALID FOR GM MAIZE T25, LIKE THE IMPROPER ASSESSMENT OF
TOXICOLOGICAL AND ALLERGENIC EFFECTS, THE MAIN ENVIRONMENTAL CONCERNS OF
AUSTRIA ARE SUMMARIZED IN THE FOLLOWING PARAGRAPHS. MORE DETAILS ARE
GIVEN IN DOLEZEL ET AL. (2007)
SPECIFIC ENVIRONMENTAL RISKS OF GM MAIZE T25WHICH WERE IDENTIFIED ARE
RISKS FOR WEED COMMUNITIES LACK OF A MONITORING PLAN REGIONAL
ASPECTS IN COMBINATION WITH COEXISTENCE ISSUES
IN SUMMARY THE RISK ASSESSMENT DATA AVAILABLE FOR GENETICALLY MODIFIED
HERBICIDE TOLERANT (GMHT) MAIZE T25 DO NOT FULFIL THE REQUIREMENTS FOR
AN ASSESSMENT OF HOW THESE NEW HERBICIDE/GM PLANT REGIMES COULD AFFECT
WEED COMMUNITIES. AS CHANGES IN WEED MANAGEMENT ARE TO BE EXPECTED WITH
INTRODUCTION OF GM MAIZE T25, A PROPER ASSESSMENT OF THE EFFECTS ON WEED
COMMUNITIES IS REQUIRED, BASED ON AN IN-DEPTH ANALYSIS OF WEEDS AND
INTERACTIONS BETWEEN THE GMO AND TARGET ORGANISMS OF GM MAIZE T25 AS
REQUIRED BOTH UNDER DIRECTIVE 90/220/EEC (ANNEX II, IV. C.3 AND C.4) AND
DIRECTIVE 2001/18/EC (ANNEX IIIB, D.). THE INSUFFICIENT CONTROL OF
CERTAIN WEEDS PROVIDED BY GLUFOSINATEAMMONIUM AND THE RESULTING SHIFT IN
WEED COMMUNITIES HAS TO BE CONSIDERED ADEQUATELY.
THE LACK OF A POST-MARKET MONITORING PLAN CONFLICTS WITH THE CURRENT
OBLIGATIONS FOR PRODUCTS SUCH AS GM MAIZE T25. ANNEX VII OF DIRECTIVE
2001/18/EC IS AN AGREED MINIMUM STANDARD FOR THIS ISSUE. FURTHERMORE,
LONG TERM EFFECTS OF THE HERBICIDE TOLERANT PLANT CANNOT BE EVALUATED
INDEPENDENTLY FROM THE RESPECTIVE HERBICIDE USE AND EFFECTS OF
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GLUFOSINATE-AMMONIUM IN COMBINATION WITH GM MAIZE T25 ON WEED
COMMUNITIES NEED TO BE ADDRESSED BY SUCH A MONITORING PLAN. ADDITIONALLY
THERE ARE OPEN QUESTIONS CONCERNING REGIONAL ASPECTS IN CONNECTION WITH
COEXISTENCE ISSUES. EU-WIDE PROVISIONS REGARDING COEXISTENCE MEASURES
(INCLUDING LIABILITY) OF GENETICALLY MODIFIED MAIZE AND CONVENTIONAL OR
ORGANIC MAIZE ARE STILL MISSING. THEREFORE ECONOMIC CONSEQUENCES FOR
ORGANIC OR CONVENTIONAL FARMERS CAN NOT BE EXCLUDED (SEE ALSO BELOW).
COMPETING RISK ASSESSMENT THIS CHAPTER EXAMINES AND ASSESSES THE
POTENTIAL RISKS OF THE GM MAIZE MON810. THE ASSESSMENT IS BASED ON THE
CURRENT SCIENTIFIC EVIDENCE CONCERNING THESE RISKS AND IS AIMED TO
FULFIL THE RECOMMENDATION BY THE WTO PANEL TO BRING THE RISK ASSESSMENT
IN LINE WITH THE REQUIREMENTS OF THE SPS AGREEMENT.
THE STRUCTURE FOLLOWS THE MOST RECENT GUIDANCE FOR SUCH ASSESSMENTS AS
GIVEN BY THE EFSA GUIDANCE DOCUMENT OF THE SCIENTIFIC PANEL ON
GENETICALLY MODIFIED ORGANISMS FOR THE RISK ASSESSMENT OF GENETICALLY
MODIFIED PLANTS AND DERIVED FOOD AND FEED (EFSA 2006). FURTHERMORE
REFERENCE IS MADE TO THE RESPECTIVE ISSUES FOR RISK ASSESSMENT AS
SPECIFIED BY DIR. 2001/18/EC ANNEX II.
1. INFORMATION ON ANY TOXIC, ALLERGENIC OR OTHER HARMFUL EFFECTS ON
HUMAN OR ANIMAL HEALTH ARISING FROM THE GM FOOD/FEED
THIS CHAPTER COVERS ISSUES WHICH ARE LISTED IN THE EFSA GUIDANCE
DOCUMENT, ANNEX III, CHAPTER D.7. THESE ISSUES FOR RISK ASSESSMENT
CORRESPOND TO THE GUIDANCE ON RISK ASSESSMENT FOR GENETICALLY MODIFIED
HIGHER PLANTS AS DETAILED IN DIR. 2001/18/EC, ANNEX II, D.2.6 (POSSIBLE
IMMEDIATE AND/OR DELAYED EFFECTS ON HUMAN HEALTH). INDIVIDUAL REFERENCE
FOR THE ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN BELOW AND
INDICATED IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED BY EFSA
(EFSA 2006).
1.1 COMPARATIVE ASSESSMENT (D.7.1)
THE RESULTS FOR SUBSTANTIAL EQUIVALENCE FOR MON810 ARE BASED ON A
COMPOSITIONAL ANALYSIS THAT HAS SEVERAL SHORTCOMINGS: THE RANGE OF
PARAMETERS MEASURED IS VERY NARROW. ONLY PROXIMATES, AMINO ACIDS AND
FATTY ACIDS ARE INCLUDED IN THE COMPARATIVE ANALYSIS. MICRONUTRIENTS AND
OTHER IMPORTANT INGREDIENTS ARE NOT CONSIDERED. FURTHERMORE, EVEN THESE
DATA DO NOT ALWAYS INCLUDE FIBRES, ADF AND NDF (IN THE CASE OF 1994
FIELD TRIALS). THIS INVESTIGATED SET OF ASSESSED COMPONENTS MUST BE
CONSIDERED AS TOO NARROW WHEN COMPARED TO THE OECD (2002) AND TO THE
EUROPABIO (2001) CONSENSUS DOCUMENTS.
DIFFERENCES ARE DETECTED BETWEEN MON810 AND THE CONTROL, E.G. FOR
GLUTAMINE, LEUCIN, PROLINE, ADF, NDF, C18:1 AND C18:2 FATTY ACIDS,
STARCH, PROTEIN. THESE DIFFERENCES ARE NOT CONSIDERED RELEVANT, AS STILL
WITHIN LITERATURE RANGES. IN ONE CASE THE LITERATURE RANGE USED WAS
EXCEEDED (PROTEIN, US TRIALS). THE APPLICANT USED AN OLDER LITERATURE
RANGE (1976) IN ORDER TO NORMALISE THE DEVIATION. NONE OF THE
DIFFERENCES WERE CONSIDERED A REASON TO REPEAT OR EXTEND THE COMPARATIVE
ANALYSIS.
LAST NOT LEAST IT APPEARS THAT NO ISOGENIC CONTROL LINE WAS USED.
IF COMPOSITIONAL ANALYSIS IS USED AS AN INDICATOR FOR UNINTENDED
EFFECTS, THE NUMBER OF SUBSTANCES, FOR WHICH DATA ARE PRESENTED, IS TOO
SMALL. IF USED FOR NUTRITIONAL ASSESSMENT, CERTAIN PROXIMATES AND
MICRONUTRIENTS ARE MISSING.
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1.2 TOXICOLOGY (D.7.8)
TOXICITY ASSESSMENT IN THE ORIGINAL DOSSIER BASICALLY RELIES ON AN ACUTE
TOXICITY TEST AND ON IN-VITRO DIGESTIBILITY STUDIES USING A BACTERIAL
CRYIA(B) PROTEIN. IN ADDITION, THE APPLICANT PROVIDED HOMOLOGY
COMPARISONS WITH KNOWN TOXIC PROTEINS AND ARGUED WITH THE SAFE HISTORY
OF BT TOXINS. RESULTS OBTAINED FROM ACUTE TOXICITY TESTS OF THE CRYIA(B)
PROTEIN ON RODENTS CANNOT BE EXTRAPOLATED FOR SUB-CHRONIC AND CHRONIC
EFFECTS. THE ASSUMPTION THAT PROTEINS CAN ONLY ACT VIA ACUTE MECHANISMS
IS NOT BACKED UP BY A SOLID EMPIRICAL BASIS. THIS HAS MEANWHILE BEEN
ACKNOWLEDGED BY RECENT GUIDANCE DOCUMENTS, WHICH ASK FOR 28-DAY
REPEATED-DOSE SUB-ACUTE TEST (EFSA 2006 AND NL BIOSAFETY COUNCIL 2003).
FOR CONDUCTING STUDIES ON TOXIC AS WELL AS ALLERGENIC PROPERTIES OF
NOVEL PROTEINS TEST PROTEINS WERE PRODUCED FROM BACTERIA. USING TEST
PROTEINS FROM MICROBES WOULD IN PRINCIPLE BE ACCEPTABLE IF THE PROTEINS
PRODUCED IN THE GM CROP AND THE MICROBE WOULD BE IDENTICAL OR AT LEAST
EQUIVALENT WITH RESPECT TO PROPERTIES INVESTIGATED IN THE TEST. HOWEVER,
SEVERAL DIFFERENCES THAT MIGHT OCCUR TO THE PROTEIN IN CASES THE SAME
GENE IS EXPRESSED IN PLANTS AND MICROBES HAVE BEEN POINTED OUT
(GURIAN-SHERMAN 2003B, FREESE AND SCHUBERT 2004). DIFFERENCES MIGHT
OCCUR AT THE LEVEL OF DNA SEQUENCE DURING TRANSFORMATION AND IN RNA
SPLICING, EVENTUALLY RESULTING IN AN ALTERED AMINO ACID SEQUENCE.
POSTTRANSLATIONAL PROCESSING INCLUDING PROTEOLYTIC PROCESSING,
GLYCOSYLATION, ACETYLATION, PHOSPHORYLATION, METHYLATION AND FOLDING
MIGHT ALSO DIFFER BETWEEN PLANTS AND MICROBES.
BACTERIAL PROTEINS WERE ALSO USED FOR IN VITRO DIGESTIBILITY STUDIES.
WHOLE PLANT FEEDING STUDIES WERE NOT PERFORMED.
IT HAS TO BE CONCLUDED THAT THE ASSESSMENT OF TOXIC PROPERTIES OF MON810
AND THE PRODUCED BT-TOXIN IS BASED ON ONLY A FEW RESULTS, WHICH
SOMETIMES ARE OBTAINED BY METHODS WHICH HAVE BEEN QUESTIONED IN THE
SCIENTIFIC LITERATURE RECENTLY. THEREFORE WE BELIEVE THAT THE DATA
PROVIDED DO NOT SUPPORT THE SAFETY-ASSUMPTION FOR MON810 MAIZE
SUFFICIENTLY.
1.3. ALLERGENICITY (D.7.9)
ALLERGENICITY TESTING IN CASE OF THE MON810 DOSSIERS IS LIMITED TO THE
INTRODUCED CRYIA(B) PROTEIN AND CONSISTS OF IN-VITRO-DIGESTIBILITY TESTS
AND HOMOLOGY COMPARISONS TO KNOWN ALLERGENS. HISTORY OF SAFE USE OF BT
PROTEINS IN GENERAL AND LOW EXPRESSION LEVELS ARE ALSO MENTIONED TO
SUPPORT THE SAFETY CLAIM.
AS DISCUSSED IN DETAIL IN SPOEK ET AL. (2005) THESE METHODS DO NOT
PROVIDE ANY DIRECT EVIDENCE OF ALLERGIC PROPERTIES AND NOT AT ALL ON
SENSITIZING PROPERTIES. FURTHERMORE, THE METHODS AND EVIDENCE USED
CANNOT BE CONSIDERED AS RELIABLE INDICATORS OF ALLERGENIC PROPERTIES. A
DETAILED REVIEW OF THE SHORTCOMINGS OF THE ALLERGENICITY ASSESSMENT
PROVIDED BY THE APPLICANT WITH REGARD TO MON810 MAIZE IS GIVEN IN
DOLEZEL ET AL. (2007). THE FOLLOWING PUNCTUATION LISTS THE MAIN POINTS
OF CRITICISM:
SCIENTIFIC STUDIES INVESTIGATING ALLERGENIC PROPERTIES OF PROTEINS IN
CONNECTION WITH THEIR DIGESTIBILITY/STABILITY COULD NOT FIND A
CORRELATION AT ALL (KENNA & EVANS 2000, FU ET AL. 2002). THEREFORE, IF
ALLERGENIC PROPERTIES ARE ONLY CONCLUDED FROM THE STABILITY OF POSSIBLE
ALLERGENS, WHICH IS INVESTIGATED USING IN-VITRO DIGESTIBILITY STUDIES,
FALSE POSITIVE AND FALSE NEGATIVE RESULTS IN SAFETY TESTING MIGHT BE
POSSIBLE. FURTHERMORE, THE DIFFERENCES IN THE DESIGN OF IN-VITRO STUDIES
CAST CONSIDERABLE DOUBT WHETHER THESE EXPERIMENTS PROVIDE MEANINGFUL
DATA AT ALL.
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ROUTINELY USED SEQUENCE COMPARISON TECHNOLOGIES SUCH AS FASTA AND
BLAST (PEARSON 2000, ALTSCHUL ET AL. 1990A, B) AS WELL AS NEW METHODS
DEVELOPED MORE SPECIFICALLY FOR PREDICTING THE ALLERGENIC POTENTIAL OF A
GIVEN PROTEIN WOULD PROVIDE FALSE POSITIVE AND FALSE NEGATIVE RESULTS IN
MANY CASES AS RESULTS OF THE COMPARISONS MIGHT DIFFER DEPENDING ON THE
PARAMETERS SET (E.G. SUBSTITUTION MATRIX AND GAP PENALTIES) (BOERKLUND
ET. AL. 2005).
THE HOMOLOGY COMPARISON REFERRED TO IN THE MON810 DOSSIER DATES BACK
TO 1990 AND 1995 RESPECTIVELY. GIVEN THE PACE OF IMMUNOLOGICAL RESEARCH
A MORE RECENT COMPARATIVE ANALYSIS WOULD HAVE INCLUDED FIVE TIMES MORE
SEQUENCES FROM ALLERGENIC PROTEINS (MARI 2005).
FURTHERMORE, EXPRESSION LEVELS OF PROVEN ALLERGENS MAY GREATLY VARY IN
DIFFERENT STRAINS, TISSUES AND DEVELOPMENTAL STAGES, AND CAN BE
INFLUENCED BY A VARIETY OF FACTORS. THIS HAS ALSO BEEN ACKNOWLEDGED BY A
JOINT FAO/WHO EXPERT CONSULTATION WHICH CONCLUDED THAT IT IS NOT
POSSIBLE TO LINK POTENTIAL ALLERGENICITY OF A GIVEN PROTEIN TO ITS
EXPRESSION LEVEL (FAO/WHO 2001).
EQUALLY IMPORTANT, ALLERGENICITY ASSESSMENT OF THE INTRODUCED PROTEIN
SHOULD BE COMPLEMENTED BY AN ASSESSMENT OF THE WHOLE-PLANT AS DESCRIBED
IN SPOEK ET AL. 2005.
1.4. MAIZE T25 - HEALTH ASPECTS
THE FOLLOWING PARAGRAPHS SUMMARIZE THE AUSTRIAN FINDINGS WITH REGARD TO
THE APPLICATION FOR PLACING ON THE MARKET OF THE GM MAIZE T25. MORE
DETAILS AND REFERENCES TO THE SCIENTIFIC LITERATURE ARE GIVEN IN DOLEZEL
ET AL. (2007).
THE ASSESSMENT OF THE DATA PROVIDED BY THE APPLICANT WITH REGARD TO THE
AUTHORIZATION OF THE GENETICALLY MODIFIED MAIZE T25 REVEALS A NUMBER OF
SHORTCOMINGS AND A LACK OF VERIFIABILITY. TOXICITY ASSESSMENT DOES NOT
CONSIDER EFFECTS BEYOND A 14-DAY STUDY OF THE INTRODUCED PROTEIN. ALL
STUDIES ARE CARRIED OUT ON ISOLATED PROTEINS. POSSIBLE TOXIC PROPERTIES
OF THE WHOLE-PLANT ARE NOT CONSIDERED AT ALL. THE ASSESSMENT OF THE
ALLERGENIC POTENTIAL IS BASED ON METHODS AND EVIDENCE THAT CANNOT BE
CONSIDERED SUFFICIENTLY RELIABLE. THE APPROACH USED IS EVEN LESS
APPROPRIATE TO ASSESS ANY DE-NOVO SENSITIZING PROPERTIES. THE
POSSIBILITY OF ALLERGENIC PROPERTIES OF THE WHOLEPLANT IS NOT CONSIDERED
AT ALL. FIELD TRIALS AND COMPOSITIONAL ANALYSIS ARE NOT FULLY VERIFIABLE
AND IT IS NOT CLEAR WHETHER THEY HAVE BEEN PROPERLY CONDUCTED. IN LIGHT
OF THE MOST RECENT GUIDANCE PROVIDED, THE INFORMATION INCLUDED IN THE
DOSSIER WOULD ALSO NOT BE SUFFICIENT FOR A MARKET AUTHORISATION UNDER
DIRECTIVE 2001/18/EC OR REGULATION (EC) 1829/2003. IN SUMMARY, FROM THE
DATA PROVIDED IN THE DOSSIER OF MAIZE T25 AND IN THE LIGHT OF RECENT
EVIDENCE FROM SCIENTIFIC LITERATURE, IT IS NEITHER POSSIBLE TO FULLY
VERIFY ALL ASPECTS OF THE RISK ASSESSMENT CONDUCTED BY THE APPLICANT NOR
TO CONCLUDE A SUFFICIENT DEGREE OF SAFETY.
2. POTENTIAL CHANGES IN THE INTERACTIONS OF THE GM PLANT WITH THE BIOTIC
ENVIRONMENT RESULTING FROM THE GENETIC MODIFICATION
THIS CHAPTER COVERS ISSUES WHICH ARE LISTED IN THE EFSA GUIDANCE
DOCUMENT, ANNEX III, CHAPTER D.9. THESE ISSUES FOR RISK ASSESSMENT
CORRESPOND TO THE GUIDANCE ON RISK ASSESSMENT FOR GENETICALLY MODIFIED
HIGHER PLANTS AS DETAILED IN DIR. 2001/18/EC, ANNEX II, D.2. INDIVIDUAL
REFERENCE FOR THE ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN
BELOW AND INDICATED IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED
BY EFSA (EFSA 2006).
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2.1 POTENTIAL FOR GENE TRANSFER (D.9.3)
THE ASSESSMENT OF THE POTENTIAL FOR GENE TRANSFER IS PRESENTED ACCORDING
TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.3 CORRESPONDING
TO ISSUE D.2.3 AS LISTED IN DIR. 2001/18/EC, ANNEX II. SPECIAL
CONSIDERATION IS GIVEN TO THE DEMAND THAT THE ASSESSMENT SHOULD ALSO
CONSIDER THE CONSEQUENCES OF LOW FREQUENCIES OF GENE TRANSFER TO RELATED
AND UNRELATED ORGANISMS (EFSA 2006). THE ASSESSMENT AS PRESENTED IN THE
FOLLOWING IS RELEVANT FOR BOTH GM MAIZE MON810 AND GM MAIZE T25.
WITH RESPECT TO GENE TRANSFER THE NOTIFIER CONCLUDED THAT THE RISK OF
GENE TRANSFER WILL BE LIMITED BY POOR DISPERSAL AND THE ABSENCE OF
WILD-LIVING SEXUALLY-COMPATIBLE PLANTS EITHER OF THE SAME OR DIFFERENT
SPECIES. HOWEVER THE REGIONAL CONDITIONS FOR MAIZE CULTIVATION IN
AUSTRIA AND THE IMPLICATION OF THESE CONDITIONS FOR OUT-CROSSING AND
GENE TRANSFER WERE NOT CONSIDERED.
POLLEN PRODUCTION AND VIABILITY WERE CONSIDERED TO BE UNCHANGED FOR GM
MAIZE MON810 (OR GM MAIZE T25) AND THEREFORE DISPERSAL AND OUT-CROSSING
SHOULD NOT BE DIFFERENT FROM OTHER MAIZE VARIETIES. THEREFORE GENE
TRANSFER FROM GM MAIZE MON810 (OR GM MAIZE T25) TO OTHER MAIZE COULD
OCCUR THROUGH POLLEN DISPERSAL DURING THE CULTIVATION OF THE CROP. MAIZE
IS PREDOMINANTLY WIND POLLINATED. MAIZE PLANTS PRODUCE POLLEN FOR 10-13
DAYS AND THE SHED POLLEN REMAINS VIABLE FOR A SHORT TIME. THOUGH IT IS
KNOWN THAT VIABLE POLLEN IS TRANSPORTED OVER VARIABLE DISTANCES RELATING
TO THE LOCAL METEOROLOGICAL CONDITIONS, THE NOTIFIER CONCLUDES THAT THE
POLLEN FROM GM MAIZE MON810 IS ONLY DISTRIBUTED OVER SHORT DISTANCES. AN
APPROXIMATION WHICH IS TYPICALLY REFERRED TO IS THAT 98% OF POLLEN
SETTLES WITHIN 25-50 M OF ITS SOURCE (EEA, 2002). HOWEVER IN EXPERIMENTS
CONDUCTED TO ESTIMATE THE AMOUNT OF POLLEN WHICH IS CARRIED FROM A PLOT
INTO NEIGHBOURING ENVIRONMENTS USING POLLEN-MASS-FILTERS DISTANCES OF UP
TO 2 700 M WERE SEEN (BEISMANN & KUHLMANN 2006; HOFMANN ET AL. 2005),
WITH SUBSTANTIAL QUANTITIES OF POLLEN FOUND AT 2 400 M DOWNWIND OF THE
POLLEN SOURCE (HOFMANN ET AL. 2005).
DATA ON POLLEN TRANSPORT HOWEVER ARE NOT FULLY CONCLUSIVE FOR ASSESSING
THE POTENTIAL FOR GENE TRANSFER THROUGH OUT-CROSSING. EMPIRICAL DATA
FROM DIFFERENT SOURCES ON OUT-CROSSING FREQUENCIES SHOW SOME VARIATION.
AN EVALUATION UNDER AUSTRIAN CONDITIONS AND BASED ON DATA FROM SEED
CERTIFICATION STUDIES INDICATED AT A DISTANCE OF APPROXIMATELY 200 M THE
OUT-CROSSING RATE IS LESS THAN 0.9 %. AT APPROXIMATELY 300 M DISTANCE
THE OUT-CROSSING RATE IS AROUND 0.1 % (PASCHER & DOLEZEL 2005). THE
EFFECT OF GENE TRANSFER CAN THUS BE RELEVANT IN A SCENARIO OF A LIMITED
AMOUNT OF GMO-PLOTS COMPARED TO NON-GMO PLOTS (10 % GM MAIZE AREA).
HIGHER RATES OF ADOPTION OF GM MAIZE CROPS LEAD TO EVEN MORE PRONOUNCED
EFFECTS. DATA FROM THE BRITISH FARM SCALE EVALUATIONS (HENRY ET AL.
2003) SHOW SIMILAR PATTERNS AND AN ISOLATION DISTANCE OF APPROXIMATELY
260 M WAS DEDUCED TO LIMIT OUT-CROSSING RATES TO APPROXIMATELY 0.1 %.
EXPERIMENTS TO TEST FOR OUT-CROSSING EFFECTS OF MAIZE IN AUSTRIA DID
EVEN ADVISE LARGER DISTANCES TO MINIMISE THE RISK FOR OUTCROSSING (AGES
2006). AN ADDITIONAL IMPORTANT CONCLUSION IS THAT OTHER FACTORS THAN
DISTANCE BETWEEN PLOTS, LIKE WINDFALL AND POLLEN CONCENTRATION AMONG
OTHERS, INFLUENCE OUT-CROSSING EFFECTS (AGES 2006). DATA FROM THE
EVALUATION OF CULTIVATION OF GM MAIZE MON810 SHOWED RESULTS THAT ARE
RELEVANT WITH REGARD TO COMPARABLE AUSTRIAN CONDITIONS. SPECIFIC DATA DO
INDICATE SUBSTANTIAL OUT-CROSSING FREQUENCIES UP TO 10% IN THE VICINITY
OF PLOTS ON WHICH GM MAIZE MON810 WAS GROWN (EDER 2006). BASED UPON
THESE RESULTS IT WAS CONCLUDED THAT A MINIMUM OF 100 M OR 150 M IS
ADVISED RESPECTIVELY IN ORDER NOT TO SURPASS THE 0.9 % THRESHOLD LEVEL
(EDER 2006; MILLER 2006).
IN CONCLUSION THE DATA INDICATE THAT GENE FLOW FROM GM MAIZE MON810 (OR
GM MAIZE T25 RESPECTIVELY) THROUGH OUT-CROSSING TO NEIGHBOURING
NON-MODIFIED VARIETIES IS LIKELY AND HAS RELEVANT ENVIRONMENTAL AND
AGRICULTURAL CONSEQUENCES IN AUSTRIA. THIS FACT IS ALSO IMPORTANT WHEN
ASSESSING ECONOMIC CONSEQUENCES OF GENE TRANSFER (SEE CHAPTER 3).
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2.2 INTERACTIONS BETWEEN THE GM PLANT AND TARGET ORGANISMS (D.9.4)
ACCORDING TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.4
CORRESPONDING TO ISSUE D.2.4 AS LISTED IN DIR. 2001/18/EC, ANNEX II AN
ASSESSMENT OF THE ENVIRONMENTAL IMPACT RESULTING FROM DIRECT AND
INDIRECT INTERACTIONS BETWEEN THE GMO AND TARGET ORGANISMS, SPECIFICALLY
THE HERBIVOROUS LEPIDOPTERAN PEST SPECIES, LIKE THE EUROPEAN CORN BORER,
WHICH ARE TARGETED BY THE HETEROLOGOUS BT-TOXIN PRODUCED BY THE GM MAIZE
MON810, IS REQUIRED. DEVELOPMENT OF RESISTANCE IN THE PEST SPECIES
AGAINST THE BT-TOXIN NEEDS TO BE CONSIDERED WITHIN THIS ASSESSMENT. THIS
IS EXEMPLIFIED BY THE EU WORKING GROUP ON BT, WHICH HAS DEVELOPED RISK
ASSESSMENTS PROTOCOLS FOR EVALUATING THE DEVELOPMENT OF RESISTANCE IN
TARGET INSECTS TO BT TOXINS (SCP, 1999).
WITH RESPECT TO RESISTANCE AND TOLERANCE ISSUES THE RESISTANCE
MANAGEMENT STRATEGY PROPOSED BY THE NOTIFIER MUST BE CONSIDERED AS
INADEQUATE. AS THE EFFECTIVENESS OF THE REFUGE STRATEGY CANNOT BE
DEDUCED FROM THE INFORMATION SUBMITTED BY THE NOTIFIER, THE SCP
EMPHASIZED THAT IT ADVISED ON THE ESTABLISHMENT OF NON-BT REFUGES AS AN
APPROPRIATE MEASURE. HOWEVER IT WAS POINTED OUT THAT DUE TO THE EXPECTED
SLOW INTRODUCTION IN EUROPE, BT CROPS WOULD BE SURROUNDED BY NATURAL
REFUGES FOR SOME TIME.
THIS ASSUMPTION HOWEVER CANNOT BE JUSTIFIED FOR THE FOLLOWING REASONS:
FIRST THE RATE OF MARKET PENETRATION OF BT MAIZE AS SEEN IN THE US WAS
FASTER THAN PREDICTED. FOR ASSESSMENT OF POSSIBLE RESISTANCE DEVELOPMENT
UNDER EUROPEAN CONDITIONS IT WAS ASSUMED THAT MARKET PENETRATION WOULD
BE SLOW. SECONDLY RESISTANCE WOULD EVOLVE LOCALLY AND THEREFORE REFUGES
MUST BE AVAILABLE, WHEREVER BT MAIZE IS LOCALLY USED AND REFUGES ARE
REQUIRED FROM THE BEGINNING OF BT PLANTING ONWARDS. RESISTANCE
MANAGEMENT IS THE RESPONSIBILITY OF EACH FARMER WHO USES BT MAIZE AND
EACH FARMER SHOULD BE REQUIRED TO IMPLEMENT MEASURES SUCH AS SETTING UP
OF REFUGES (SEE E.G. ANDOW IN WTO, 2006 FOR REFERENCE).
THE INSECT RESISTANCE MANAGEMENT (IRM) PLAN ITSELF, WHICH WAS PROVIDED
BY THE NOTIFIER IS VERY GENERAL AND DOES NOT GIVE DETAILED INFORMATION
ON HOW IT WILL BE IMPLEMENTED. ALTHOUGH THE NOTIFIER RECOMMENDS A
MANAGED REFUGE APPROACH AND STATES THAT A SURVEILLANCE PROGRAM WILL BE
IMPLEMENTED, NO EXACT INFORMATION ON THE IMPLEMENTATION DETAILS OF THIS
PROGRAM IS GIVEN.
SPECIFICALLY WITH RESPECT TO SUSCEPTIBILITY STUDIES THE NOTIFIER REFERS
ONLY TO STUDIES IN THE US AND ITALY. WITHOUT ADEQUATE INFORMATION ON
BASELINE SUSCEPTIBILITIES OF PEST SPECIES AND INFORMATION ON INITIAL
RESISTANCE ALLELE FREQUENCIES IN THESE SPECIES THE RATE AT WHICH
RESISTANCE WILL EVOLVE CAN NOT BE DETERMINED. ADDITIONALLY IT IS NOT
POSSIBLE TO DEDUCE HOW THIS RATE DIFFERS AMONG DIFFERENT POPULATIONS OF
THIS INSECT SPECIES (HUANG ET AL. 1997). THESE ISSUES SHOULD BE
INVESTIGATED FOR EACH SEPARATE EUROPEAN CORN BORER POPULATION OR EVEN
SUB-POPULATION (CHAUFAUX ET AL. 2001).
THE SCIENTIFIC FACTS THUS DO NOT CONVINCINGLY SUPPORT THE HYPOTHESES ON
WHICH THE PROPOSED PLAN IS BASED. WITHOUT DEMONSTRATION BY THE NOTIFIER
OF THE SPATIAL DISTRIBUTION AND TOTAL AREAS OF GM MAIZE MON810 PLOTS IN
RELATION TO OTHER AREAS OF MAIZE CULTIVATION THE CONCLUSIONS DRAWN BY
THE NOTIFIER CANNOT BE VALIDATED. FURTHERMORE THE STRATEGY DOES NOT TAKE
INTO ACCOUNT THE DIFFERENT DISPERSAL CAPACITIES OF OTHER PEST SPECIES,
INCLUDING SESAMIA SPECIES (MEDITERRANEAN CORN STALK BORER). RESISTANCE
MANAGEMENT STRATEGIES DESIGNED FOR THE EUROPEAN CORN BORER ARE LESS
EFFICIENT FOR THE LESS POLYPHAGOUS AND MORE SEDENTARY SESAMIA
(EIZAGUIRRE ET AL. 2006). FURTHERMORE SESAMIA FOR REASONS OF REDUCED
SUSCEPTIBILITY IS LESS RESPONSIVE TO THE PROPOSED MANAGEMENT STRATEGY.
ADDITIONALLY IRM PLANS HAVE TO BE CARRIED OUT IN COMBINATION WITH
SYSTEMATIC MONITORING IN ORDER TO DETECT RESISTANCE AT THE VERY TIME OF
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AND OTHER ECOLOGICAL FACTORS BETWEEN DIFFERENT POPULATIONS OF THE
RESPECTIVE PESTS AS WELL AS AGRONOMIC PRACTICES MIGHT DIFFER LOCALLY,
THE RESULTS OF THE EXPERIENCES GAINED FROM BT MAIZE CULTIVATION IN SPAIN
ARE NOT APPLICABLE WITHOUT FURTHER CONSIDERATION TO OTHER EUROPEAN
AGRICULTURAL SYSTEMS. THEREFORE AN ADAPTATION OF THE IRM STRATEGY MUST
BE ENVISAGED. AGAIN IT HAS TO BE TAKEN INTO ACCOUNT THAT SEVERAL
VARIETIES OF GM MAIZE MON810 ARE ALREADY APPROVED WITHIN THE EUROPEAN
UNION FOR CULTIVATION. THEREFORE IT CAN BE EXPECTED THAT FURTHER
ADOPTION RATES OF GM MAIZE MON810 WILL BE RATHER HIGH IN EUROPE. INDEED
RECENT DATA ON ADOPTION TRENDS IN EUROPE, WHICH CONFIRM AN INCREASE IN
CULTIVATION AREA OF APPROXIMATELY 70% FOR THE LAST SEASON, SUPPORT THIS
NOTION. HIGH ADOPTION RATES OF BT MAIZE VARIETIES HAVE ALSO BEEN
EXPERIENCED IN THE US (CARPENTER & GIANESSI 2001), ALTHOUGH A SLOW RATE
FOR INTRODUCTION OF THIS TYPE OF GM MAIZE HAD BEEN PREVIOUSLY PREDICTED.
THEREFORE THE EFFECTIVENESS OF THE STRATEGY PROPOSED BY THE NOTIFIER IN
ORDER TO PREVENT THE DEVELOPMENT OF RESISTANCE IN TARGET SPECIES, LIKE
THE EUROPEAN CORN BORER, IS DOUBTFUL. A REFINED STRATEGY ON RESISTANCE
MANAGEMENT NEEDS TO BE PROPOSED BY THE NOTIFIER AND ADEQUATE BASELINE
INFORMATION ON THE PEST BIOLOGY AND ECOLOGY AND A WORKABLE IRM PLAN HAS
TO BE SUBMITTED.
2.3 INTERACTIONS OF THE GM PLANT WITH NON-TARGET ORGANISMS (D.9.5)
ACCORDING TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.5
CORRESPONDING TO ISSUE D.2.5 AS LISTED IN DIR. 2001/18/EC, ANNEX II AN
ASSESSMENT OF THE ENVIRONMENTAL IMPACT RESULTING FROM DIRECT AND
INDIRECT INTERACTIONS BETWEEN THE GMO AND NON-TARGET ORGANISMS IS
REQUIRED. ANY EFFECTS ON ORGANISMS WHICH INTERACT WITH THE TARGET
ORGANISMS NEED TO BE TAKEN INTO ACCOUNT AS WELL.
2.3.1 EFFECTS ON OTHER NON-TARGET LEPIDOPTERAN SPECIES
POSSIBLE RISKS FOR NON TARGET ORGANISMS WERE CONSIDERED BY THE NOTIFIER
AND IN ALL PRECEDING ASSESSMENTS (E.G. SCP, 1998). THE CONCLUSION BY THE
NOTIFIER WAS BASED ON THE INFORMATION AS SUBMITTED. THIS INFORMATION IS
INTERPRETED IN A WAY THAT NO RELEVANT RISK FOR NON-TARGET HERBIVORES
INCLUDING VERTEBRATES IS IDENTIFIED.
HOWEVER WITH REGARD TO CURRENT ASSESSMENTS OF THE INFORMATION AVAILABLE
TO JUDGE POSSIBLE UNINTENDED EFFECTS ON NON-TARGET INSECTS THIS
CONCLUSION CANNOT BE SUPPORTED. MARVIER ET AL. (2007) RECENTLY
IDENTIFIED A NUMBER OF WEAKNESSES IN MOST OF THE AVAILABLE FIELD STUDIES
ON POTENTIAL ADVERSE EFFECTS OF INSECT RESISTANT GM CROPS, DURING AN
EFFORT TO SET UP A COMPREHENSIVE REPOSITORY OF DATA FOR EMPIRICAL
ASSESSMENTS. IN OUR OPINION THESE WEAKNESSES ALSO SEVERELY LIMIT THE
CONCLUSIVENESS OF THE FIELD TEST DATA SUBMITTED ON GM MAIZE MON810 (SEE
CHAPTER 1.3.2 FOR FURTHER DISCUSSION).
IT IS EVIDENT THAT GM MAIZE MON810 HAS THE POTENTIAL TO BE TOXIC TO
CERTAIN SPECIES OF LEPIDOPTERA AND THAT THIS ISSUE MUST BE DEALT WITH ON
A SPECIES-BY-SPECIES BASIS. THE NOTIFIER ASSUMES WITHOUT REFERENCE TO
REGIONAL CONDITIONS THAT CULTIVATED FIELDS ARE NOT CONSIDERED AS
IMPORTANT REPRODUCTIVE AREAS FOR LEPIDOPTERAN SPECIES AND EXPOSURE OF
NONTARGET LEPIDOPTERAN SPECIES WOULD NOT BE SIGNIFICANT. AN ASSESSMENT
OF RISKS TO NON-TARGET BUTTERFLIES ESPECIALLY RELATING TO EUROPEAN AND
SPECIFICALLY THE AUSTRIAN AGRICULTURAL CONDITIONS HAS NOT BEEN CARRIED
OUT IN THE RISK ASSESSMENT, IN SPITE OF INFORMATION THAT MANY SPECIES OF
BUTTERFLIES ARE PRESENT IN AGRICULTURAL AREAS (FELKE & LANGENBRUCH
2005).
GIVEN THE SUBSTANTIAL TRANSPORT OF TRANSGENIC POLLEN CONTAINING BT TOXIN
FROM THE GROWING AREAS INTO THE FIELD MARGINS AND TO ADJACENT HABITATS,
THESE SPECIES ARE VERY LIKELY TO BE EXPOSED TO POLLEN FROM GM MAIZE
MON810 UPON CULTIVATION. RECENT ANALYSES BASED ON DATA FROM STUDIES IN
GERMANY (E.G. HOFMANN ET AL. 2005) INDICATE THAT AN AVERAGE DEPOSITION
OF MORE THAN 5 POLLEN/CM 2 CAN BE EXPECTED AT A DISTANCE OF 300 M FROM
ADJACENT MAIZE FIELDS. IN THIS CONTEXT IT IS IMPORTANT TO NOTE THAT
INTAKE OF SMALL AMOUNTS
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OF POLLEN CONTAINING BT TOXIN CAUSE SUB-LETHAL EFFECTS ON NATIVE
LEPIDOPTERA LARVAE SUCH AS THE PEACOCK BUTTERFLY, INACHIS IO (FELKE &
LANGENBRUCH 2005). IN AUSTRIA THIS BUTTERFLY IS COMMONLY FOUND IN
HABITATS NEXT TO CULTIVATED AREAS OF MAIZE (TRAXLER ET AL. 2005).
OUR ASSESSMENT THAT OTHER BUTTERFLIES LIVING IN AGRICULTURAL HABITATS
WOULD BE SERIOUSLY AFFECTED IN CASE OF CULTIVATION IS SUPPORTED BY
RECENT RESEARCH (SZEKACS & DARVAS 2006). OTHER SCIENTIFIC STUDIES HAVE
RECENTLY INDICATED THAT CERTAIN NON-TARGET LEPIDOPTERA, LIKE MONARCH
BUTTERFLY LARVAE, SHOW PROLONGED DEVELOPMENTAL TIME AND REDUCED SURVIVAL
WHEN EXPOSED TO POLLEN OF BT MAIZE MON810 EITHER FOR SHORT OR FOR
PROLONGED TIME UNDER FIELD CONDITIONS, POSSIBLY RESULTING IN UP TO 25%
FEWER SURVIVING LARVAE (DIVELY ET AL. 2004). ALSO ADVERSE EFFECTS ON
PUPAE AND ADULTS OF THE MONARCH BUTTERFLY WERE REPORTED IN THIS STUDY.
POSSIBLE ADVERSE EFFECTS ON NON-TARGET LEPIDOPTERA THROUGH THE
CONSUMPTION OF ANTHERS FROM BT MAIZE PLANTS (ANDERSON ET AL. 2004, FELKE
& LANGENBRUCH 2005) AND ESPECIALLY THE COMBINED EFFECTS OF POLLEN AND
ANTHERS OF BT MAIZE CONTAINING THE BT TOXIN (ANDERSON ET AL. 2005) HAVE
SO FAR NOT BEEN TAKEN INTO CONSIDERATION. ALSO LEPIDOPTERA OTHER THAN
THE MONARCH BUTTERFLY HAVE BEEN SHOWN TO SUFFER SUBLETHAL OR LETHAL
EFFECTS WHEN EXPOSED TO BT MAIZE (VOJTECH ET AL. 2005, DUTTON ET AL.
2005). IT IS STILL UNCERTAIN WHICH OTHER NON-TARGET BUTTERFLIES MIGHT BE
ADVERSELY AFFECTED BY THE CONSUMPTION OF BT CORN POLLEN OR ANTHERS.
OUT OF 215 BUTTERFLY SPECIES OCCURRING IN AUSTRIA, 152 SPECIES HAVE BEEN
REPORTED FROM AGRICULTURAL AREAS AND MORE THAN HALF OF THOSE SPECIES ARE
ALREADY CLASSIFIED AS EITHER NEAR THREATENED, VULNERABLE, ENDANGERED OR
CRITICALLY ENDANGERED (TRAXLER ET AL. 2005). TRAXLER ET AL. (2005)
FURTHER SHOW THAT DEVELOPMENT OF THESE BUTTERFLIES DOES COINCIDE WITH
THE TIME OF POLLEN SHED OF CULTIVATED MAIZE FOR 75 - 100% OF THE TIME IN
CASE OF 29 BUTTERFLY SPECIES. SHORTER OVERLAPS OF RESPECTIVE TIMEFRAMES
ARE SEEN WITH THE OTHER BUTTERFLY SPECIES: 25% OVERLAP FOR 51 SPECIES,
UP TO 50% OVERLAP FOR ANOTHER 59 SPECIES AND 50 - 75% FOR 5 SPECIES.
BASED ON A NUMBER OF CHARACTERISTICS (DEVELOPMENTAL OVERLAP WITH
FLOWERING TIME OF MAIZE, ECOLOGICAL CHARACTERISTICS OF BUTTERFLIES,
INCIDENCE OF ENDANGERED SPECIES, BIODIVERSITY OF BUTTERFLY SPECIES) A
RISK-INDEX FOR BUTTERFLIES WAS DEDUCED AND SHOWS THAT AREAS IN AUSTRIA,
WHERE INSECT RESISTANT GM MAIZE VARIETIES ARE POTENTIALLY GROWN, ARE IN
THE VICINITY OF AREAS, WHICH ARE CHARACTERISED BY HIGH BIODIVERSITY OF
BUTTERFLIES AND A HIGH NUMBER OF ENDANGERED BUTTERFLY SPECIES (TRAXLER
ET AL. 2005).
THEREFORE IN CONCLUSION WE EXPECT IT TO BE LIKELY THAT BUTTERFLY SPECIES
WHICH ARE ALREADY ENDANGERED WOULD BE ADDITIONALLY AFFECTED BY
CULTIVATION OF GM MAIZE MON810. SINCE ADDITIONAL IMPACTS ON ENDANGERED
SPECIES SHOULD BE MINIMISED THE CULTIVATION OF GM MAIZE MON810 IS
EXPECTED TO HAVE NEGATIVE EFFECTS.
2.3.2. EFFECTS ON OTHER NON-TARGET ORGANISMS
CONCERNING THE IMPORTANT ASPECT OF POTENTIAL ADVERSE EFFECTS ON
DIFFERENT CLASSES OF NONTARGET ORGANISMS A STUDY ON THE META-ANALYSIS OF
AVAILABLE DATA ON FIELD TRIALS FROM DIFFERENT SOURCES WAS PUBLISHED
RECENTLY (MARVIER ET AL. 2007). THIS WORK USES AVAILABLE DATA ON EFFECTS
OF BT TOXINS ON DIFFERENT GROUPS OF ARTHROPOD INSECTS. TO ANALYSE
EFFECTS OF CRY1A(B) TOXIN AS CONTAINED IN GM MAIZE MON810 DATA ON
ABUNDANCE OF COLEOPTERA, HEMIPTERA, HYMENOPTERA, ARANAE, NEUROPTERA,
DIPTERA, THYSANOPTERA AND COLLEMBOLA IN ADDITION TO LEPIDOPTERA WERE
ANALYSED. FOR ALL KINDS OF CRY1A(B) EXPRESSING GM MAIZE VARIETIES THE
OVERALL MEAN ABUNDANCE OF NON-TARGET INVERTEBRATES WAS SIGNIFICANTLY
LOWER FOR THE GM-VARIETIES COMPARED TO CONTROL OF NON-GM MAIZE VARIETIES
WHICH WERE NOT TREATED WITH INSECTICIDES. THIS FORM OF COMPARISON IS
RELEVANT TO ASSESS ANY DIFFERENCES OF THE POTENTIAL CULTIVATION OF GM
MAIZE MON810 WITH CONVENTIONAL VARIETIES GROWN UNDER CONDITIONS OF
ORGANIC AGRICULTURE AND REDUCED INSECT MANAGEMENT BY INSECTICIDES. THESE
MANAGEMENT PRACTICES ARE FAVOURED BY THE AUSTRIAN NATIONAL PLANS FOR
IMPLEMENTATION OF ECO-FRIENDLY AGRICULTURE. SPECIFIC ADDITIONAL FUNDING
TO FARMERS IN AUSTRIA IS CONNECTED TO APPLICATION OF SUCH MANAGEMENT
PRACTICES.
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SIGNIFICANT EFFECTS OF CRY1A(B) TOXIN EXPRESSING GM MAIZE ARE FOUND
SPECIFICALLY FOR HYMENOPTERA AND COLLEMBOLA. SPECIFIC DATA FOR GM MAIZE
MON810 ALSO SHOW A LOWER AVERAGE ABUNDANCE OF NON-TARGET INVERTEBRATE
SPECIES ON PLOTS OF GM MAIZE MON810 COMPARED WITH UNTREATED PLOTS OF
NON-MODIFIED MAIZE, BUT WITH A LOWER LEVEL OF SIGNIFICANCE.
ANOTHER OVERVIEW ON RESULTS CONCERNING THE POTENTIAL ADVERSE EFFECTS OF
GM PLANTS EXPRESSING BT TOXINS LIKE GM MAIZE MON810 WAS PUBLISHED BY
LOEVEI & ARPAIA (2005). THEY CONCLUDED THAT PARAMETERS CONNECTED TO
DEVELOPMENT, GENERAL BIOLOGY, OR FITNESS OF PREDATING INSECTS, LIKE
SURVIVAL/MORTALITY, DEVELOPMENT TIME, BODY MASS/SIZE, PREY CONSUMPTION,
REPRODUCTION, LONGEVITY, EGG VIABILITY OR BEHAVIOUR, WERE NEGATIVELY
AFFECTED IN 41 % OF THE FEEDING TESTS (IN 30% OF CASES SIGNIFICANTLY
NEGATIVE). AN ANALYSIS OF THE RESPECTIVE RESULTS FOR FEEDING TESTS WITH
PARASITOIDS SHOWED COMPARABLE DATA (LOEVEI & ARPAIA 2005). EVEN
CONSIDERING THE FACT THAT WORST CASE SCENARIO TESTING METHODS WERE NOT
CONSISTENTLY APPLIED AND MANY IMPORTANT SPECIES HAVE NOT BEEN TESTED AT
ALL, THIS DOES CONSTITUTE A CLEAR INDICATION THAT MOST LIKELY NEGATIVE
EFFECTS HAVE TO BE EXPECTED.
IN THE REPORT BY MARVIER ET AL. (2007) THE AUTHORS CONSISTENTLY FOUND
RELEVANT DEFICIENCIES WITH REGARD TO THE ORIGINAL DATA. SPECIFICALLY
THEY REPORTED THAT OUT OF 64 STUDIES ANALYSED
40% OF REPORTS DID NOT INDICATE THE VARIANCE FOR THE REPORTED
TREATMENT MEANS, 22% USED THE SUBSAMPLES IN AN IMPROPER WAY TO
CALCULATE MEASURES OF VARIANCE AND FOR 20% OF THE REPORTS THE SAMPLE
SIZES WERE NOT CLEARLY PRESENTED.
THEY INDICATED THAT SOME OF THESE INSUFFICIENCIES COULD BE CLARIFIED BY
ADDITIONAL INFORMATION SUBMITTED BY THE AUTHORS UPON REQUEST. THEIR
CONCLUSION TOWARDS THESE DEFICIENCIES IS THAT REGULATORY AGENCIES SHOULD
REQUIRE SUBMITTING THE DATA ON FIELD TESTS IN AN ADEQUATELY STRUCTURED
WAY, TO BE ABLE TO SPOT ANY LACKING INFORMATION WHICH IS CRUCIAL FOR AN
ADEQUATE ASSESSMENT. ANY APPROVALS SHOULD BE POSTPONED UNTIL COMPLETE
SETS OF DATA HAVE BEEN SUBMITTED AND ASSESSED. SINCE SIMILAR DATA WERE
USED FOR THE PRECEDING RISK ASSESSMENTS OF GM MAIZE MON810, THE
CONCLUSIONS DRAWN IN THESE ASSESSMENTS SHOULD BE REGARDED AS TENTATIVE
AND SUBJECT TO REVIEW BASED ON ASSESSMENT OF ADEQUATE DATA.
BT TOXIN EXPOSITION OF NON-TARGET ORGANISMS OF HIGHER TROPHIC LEVELS
LIKE PREDATORS AND PARASITOIDS HAS BEEN DOCUMENTED IN RECENT STUDIES
(HARWOOD ET AL. 2005; ZWAHLEN & ANDOW 2005; OBRIST ET AL. 2006). FOR
SOME OF THESE SPECIES A LOWER ABUNDANCE ON PLOTS OF BT MAIZE VARIETIES
HAS BEEN REPORTED (E.G. PILCHER ET AL. 2005; BOURGUET ET AL. 2002). ANY
LARGE-SCALE APPLICATION OF GM MAIZE MON810 WOULD THUS LEAD TO
EXACERBATED EFFECTS ON SPECIFIC NATURAL ENEMIES OF MAIZE PEST INSECTS.
EFFECTS ON WATER DWELLING ORGANISMS
THE EFFECT OF THE BT-TOXIN INCORPORATED IN GM MAIZE MON810 ON AQUATIC
NON-TARGET SPECIES WAS NOT SPECIFICALLY CONSIDERED BY THE NOTIFIER AND
DURING THE PRECEDING RISK ASSESSMENTS (SEE E.G. SCP 1998). A RECENT
PUBLICATION (ROSI-MARSHALL ET AL. 2007) REPORTS ADVERSE EFFECTS ON
AQUATIC INSECT SPECIES AND THEIR DATA SUBSTANTIATE THE PREVIOUSLY
HYPOTHESISED RISK POTENTIAL THAT MATERIAL DERIVED FROM GM MAIZE MON810
CONTAINING THE CRY1A(B) PROTEIN COULD AFFECT THE FOOD CHAIN IN AQUATIC
ENVIRONMENTS. THUS ANY COMPREHENSIVE RISK ASSESSMENT NEEDS TO ALSO TAKE
INTO ACCOUNT EFFECTS ON WATER-DWELLING INSECTS.
THE NECESSARY ASSESSMENT OF SPECIFIC EFFECTS OF GM MAIZE MON810 CANNOT
BE BASED ON DATA CONCERNING EFFECTS OF INSECTICIDAL SPRAYS PRODUCED FROM
BACILLUS THURINGIENSIS VAR. ISRAELENSIS (BTI) ON AQUATIC ENVIRONMENTS.
DUE TO DIFFERENCES IN EXPOSURE AND THE NATURE OF BT PROTEINS PRESENT IN
BTI THE PREVIOUS ASSESSMENTS OF BTI CANNOT BE REGARDED OF HIGH
SIGNIFICANCE FOR ASSESSING THE RISK OF BT-TOXINS DERIVED FROM GM MAIZE
MON810 (HERSHEY
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ET AL. 1998, PONT ET AL. 1999, AND JACKSON ET AL. 2002 AS CITED IN
ROSI-MARSHALL ET AL. 2007). THE RISK ASSESSMENT MUST BE BASED ON STUDIES
DIRECTLY EVALUATING THE SPECIFIC EFFECTS OF GM MAIZE MON810 ON AQUATIC
NON-TARGET SPECIES. RECENTLY A STUDY ADDRESSING SUCH ADVERSE EFFECTS HAS
BEEN PUBLISHED FOR CERTAIN TRICHOPTERA SPECIES, WHICH CAN CONSUME
MATERIAL DERIVED FROM GM MAIZE MON810 CULTIVATED IN THE VICINITY OF
AQUATIC ECOSYSTEMS (ROSI-MARSHALL ET AL. 2007).
THE RESULTS DO DEMONSTRATE THAT MATERIAL DERIVED FROM GM MAIZE MON810 IN
AGRICULTURAL ENVIRONMENTS IS DEPOSITED IN NEIGHBOURING AQUATIC
ECOSYSTEMS AND AVAILABLE TO AQUATIC INSECTS OF DIFFERENT FEEDING
BEHAVIOUR, LIKE CERTAIN WATER-DWELLING TRICHOPTERA SPECIES (FILTER
FEEDING AND LEAF-SHREDDING TRICHOPTERAN GROUPS). THESE INSECTS ARE
FEEDING ON MATERIAL CONTAINING BT-TOXIN AND DO INGEST BT-TOXIN FROM THIS
SOURCE IN DETECTABLE AND RELEVANT QUANTITIES. AS A SUPPORTING LINE OF
EVIDENCE LABORATORY FEEDING TESTS WITH THESE TRICHOPTERA SPECIES
DEMONSTRATE THAT INGESTED BT-TOXIN DOES LEAD TO ADVERSE EFFECTS, LIKE
SIGNIFICANTLY REDUCED GROWTH RATES OF LEAF-SHREDDING TRICHOPTERA SPECIES
AND ELEVATED MORTALITY RATES OF SPECIES FEEDING ON ALGAL BIOFILMS, WHICH
CONTAIN POLLEN FROM GM MAIZE MON810. THE EFFECTS ARE PLAUSIBLE GIVEN THE
CLOSE RELATIONSHIP OF TARGET LEPIDOPTERA AND THE TRICHOPTERA ANALYSED IN
THE STUDY. ADVERSE EFFECTS ON AQUATIC SPECIES LIKE TRICHOPTERA WILL
PREDICTABLY REDUCE THE BIOMASS AVAILABLE FOR PREDATING SPECIES AND
THEREFORE HAVE RELEVANT EFFECTS ON AQUATIC FOOD-WEBS AND BIOTA IN
AGRICULTURAL AREAS, WHERE GM MAIZE MON810 IS CULTIVATED.
SIMILAR TO THE SITUATION AS ENCOUNTERED AT THE SITES OF SAMPLING IN
ROSI-MARSCHALL ET AL. (2007) MAIZE IS CULTURED IN AUSTRIA IN CLOSE
VICINITY TO AQUATIC ECOSYSTEMS AS DESCRIBED IN AN ASSESSMENT OF HABITATS
FOUND IN TYPICAL AREAS OF MAIZE CULTIVATION, E.G. IN CARINTHIA
(WUTSCHEIN/THON), UPPER AUSTRIA (METTENSDORF), BURGENLAND (KOTEZICKEN),
AND LOWER AUSTRIA (EBREICHSDORF) (HEISSENBERGER ET AL. 2004).
ADDITIONALLY MATERIAL CONTAINING CRY1AB TOXIN FROM GM MAIZE MON810 COULD
BE INTRODUCED INTO AQUATIC ECOSYSTEMS FROM MANURE USED AS ORGANIC
FERTILISER AND MAIZE MATERIAL FROM SILAGE (MALITZKY 2007). FURTHERMORE
TRICHOPTERA SPECIES RELATED TO THE ONES ANALYSED IN THE ABOVE MENTIONED
STUDY DO ALSO OCCUR IN AUSTRIA. SPECIFICALLY 19 SPECIES OF
HYDROPSYCHIDAE AND FOUR SPECIES OF LEPIDOSTOMATIDAE WERE REPORTED FOR
AUSTRIA (GRAF ET AL. 2002). THEREFORE SIMILAR ADVERSE EFFECTS AS
DEMONSTRATED IN THE ABOVE MENTIONED RESEARCH HAVE TO BE EXPECTED IN
AUSTRIA RESULTING FROM ANY CULTIVATION OF GM MAIZE MON810.
WITH REGARD TO THE DATA ON TRICHOPTERA DISTRIBUTION IN AUSTRIA IT IS
EVIDENT THAT THERE IS A TWOFOLD RISK FOR THIS GROUP OF AQUATIC SPECIES
BY THE BT TOXINS AS CONTAINED IN GM MAIZE MON810: A NUMBER OF
TRICHOPTERA SPECIES IS CURRENTLY ENDANGERED IN AUSTRIA AND ADDITIONAL
ADVERSE EFFECTS BY GM MAIZE MON810 ON THEIR POPULATION ARE RELEVANT AS
EXPLICITLY MENTIONED BY MALITZKY (2007). SPECIFICALLY MORE THAN HALF OF
THE HYDROPSYCHIDAE AND LEPIDOSTOMIDAE SPECIES (THE GROUPS OF TRICHOPTERA
EXAMINED IN ROSI-MARSCHALL ET AL. (2007) FOR ADVERSE EFFECTS) ARE LISTED
AS ENDANGERED IN AUSTRIA. THREE OF THOSE SPECIES ARE RECOGNISED AS
HIGHLY ENDANGERED OR EVEN CRITICALLY ENDANGERED (MALITZKY 2007). THESE
ENDANGERED SPECIES ARE VULNERABLE AGAINST ADDITIONAL NEGATIVE EFFECTS,
LIKE ANY ADVERSE EFFECTS BY GM MAIZE MON810. SECONDLY SOME OTHER
TRICHOPTERA SPECIES ARE VERY ABUNDANT AND THEREFORE
IMPORTANT SOURCES OF PREY FOR AQUATIC PREDATORS, E.G. FISH. ADVERSE
EFFECTS OF THE CULTIVATION OF GM MAIZE MON810 AS DESCRIBED IN
ROSI-MARSCHALL ET AL. (2007) WOULD IMPACT ON THIS FOOD WEB AND THUS
NEGATIVELY AFFECT HIGHER TROPHIC LEVELS OF THE EXPOSED AQUATIC
ECOSYSTEMS.
SINCE ANY UNDESIRED IMPAIRMENT OF AQUATIC HABITATS SHOULD BE AVOIDED,
THE POTENTIAL EFFECT OF GM MAIZE MON810 ON THESE ECOSYSTEMS HAS TO BE
REGARDED AS RELEVANT, CONSIDERING THAT IT IS UNKNOWN DUE TO LACKING DATA
WHICH ADDITIONAL EFFECTS THE CULTIVATION OF GM MAIZE MON810 MIGHT HAVE
ON AQUATIC ECOSYSTEMS.
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2.3.3. EFFECTS ON NON-TARGET SOIL ORGANISMS
ACCORDING TO THE NOTIFIER RISKS TO SOIL ORGANISMS AND SOIL FUNCTION
THROUGH DEGRADATION OF GM PLANT MATERIAL OR RISKS THROUGH CONTAMINATION
OF GROUND WATER ARE CONSIDERED TO BE EXTREMELY LOW.
HOWEVER A RANGE OF INFORMATION WAS LEFT UNCONSIDERED IN PREVIOUS
ASSESSMENTS. THE ACTUAL RATES AND DEGRADATION PROCESSES FOR LARGE
PROTEINS IN SOILS ARE POORLY UNDERSTOOD. THERE IS EVIDENCE THAT BT MAIZE
RELEASES THE BT TOXIN IN ROOT EXUDATES (SAXENA ET AL. 2004). UNDER THE
AUSTRIAN CONDITIONS THE EXPOSURE OF SOIL ORGANISMS TOWARDS CRY1AB TOXIN
FROM GM MAIZE MON810 COULD BE SUBSTANTIALLY HIGHER AS ASSUMED BY THE
NOTIFIER. RECENT DATA INDICATE THAT BT MAIZE DECOMPOSES SLOWER IN THE
SOIL THAN NON-BT PLANTS (FLORES ET AL. 2005). THEREFORE THE BT TOXIN
LOAD IN MAIZE FIELDS CAN BE SUBSTANTIAL, WHICH MAKES LARGESCALE EFFECTS
POSSIBLE. FURTHERMORE RESULTS SHOW THAT THE BT TOXIN CAN PERSISTS IN
SOIL FOR MONTHS RETAINING ITS INSECTICIDAL ACTIVITY (SAXENA & STOTZKY
2002, STOTZKY 2004). THIS IS RELEVANT FOR THE ASSESSMENT OF ADVERSE
EFFECTS OF BT TOXINS RELEASED INTO THE SOIL. ADSORBED TO SOIL MINERALS
THE BT TOXIN IN ACTIVE FORM CAN BE DETECTED LONGER THAN 200 DAYS AND
THUS PERSISTS LONGER THAN THE VEGETATION PERIOD OF MAIZE PLANTS (CECCIO
& STOTZKY, 2001, ZWAHLEN ET AL. 2003A). THE AMOUNTS OF BT TOXINS
DELIVERED TO THE SOIL ARE MOST PRONOUNCED WITH GM PLANTS LIKE BT-COTTON
AND BT-MAIZE (CLARK ET AL. 2005). CRY1AB TOXIN IS RELEASED FROM THE
ROOTS OF GM MAIZE PLANTS AND CAN ACCUMULATE IN THE RHIZOSPHERE TO
RELEVANT CONCENTRATIONS (SAXENA & STOTZKY 2005).
ADVERSE EFFECTS FOR SOIL LIVING NON-TARGET ORGANISMS WERE DISCUSSED IN A
SUBSTANTIAL NUMBER OF RECENT PUBLICATIONS (ANDOW & HILBECK 2004, DALE ET
AL. 2002, HILBECK 2001, LIU ET AL. 2005, MARVIER 2001, ZWAHLEN ET AL.
2003A AND 2003B). SPECIFICALLY HERBIVOROUS AND DETRIVOROUS ORGANISMS
WOULD BE EXPOSED TO BT TOXINS FROM GM MAIZE MON810, AS WELL AS PREDATING
SPECIES FEEDING ON EXPOSED ORGANISMS.
A DIRECT IMPACT IS AN INHIBITORY EFFECT FOR THE FORMATION OF SYMBIONTIC
FUNGAL COMMUNITIES IN THE ROOTS OF HIGHER PLANTS BY THE MYCORRHIZA FUNGI
(CASTALDINI ET AL. 2005). SOIL LIVING ARTHROPODS ARE INGESTING THE
CRY1AB TOXIN AND SHOW VARIOUS ADVERSE EFFECTS: EARTHWORMS SHOW A
DECREASE IN THEIR WEIGHT AFTER 200 DAYS EXPOSITION (ZWAHLEN ET AL.
2003B) AND DEVELOPMENTAL DEFECTS (REDUCED HATCHING RATES) (VERECSI ET AL
2006). ADDITIONALLY OTHER SOIL ORGANISMS LIKE NEMATODES AND ISOPODS DO
SHOW NEGATIVE EFFECTS (GROWTH DEPRESSION, LOWER FOOD INTAKE) UPON
EXPOSITION TO CRY1AB TOXIN FROM GM MAIZE MON810 (GRIFFITHS ET AL. 2006;
WANDELER ET AL. 2002). ANOTHER GROUP WHICH IS POSSIBLY AFFECTED ARE
INSECT LARVAE E.G. CERTAIN CARABIDAE WHICH WOULD FEED ON MATERIAL
DERIVED FROM GM MAIZE MON810 (LANGENBRUCH ET AL. 2006). MEISSLE ET AL.
(2005) SHOWED THAT CARABID LARVAE SHOWED ELEVATED MORTALITY WHEN FED ON
SPODOPTERA REARED WITH GM MAIZE CONTAINING CRY TOXINS.
TAKEN TOGETHER EVIDENCE IS AVAILABLE TO SHOW THAT THE RISK FOR SOIL
ORGANISMS IS RELEVANT UNDER REGIONAL AUSTRIAN CONDITIONS. SINCE HEALTHY
SOILS ARE A PREREQUISITE FOR LOW-INPUT AGRICULTURE AND ORGANIC
AGRICULTURE, THE POTENTIAL EFFECTS OF THE CULTIVATION OF GM MAIZE MON810
ARE LIKELY LEADING TO A NEGATIVE IMPACT ON SOIL QUALITY.
3. ASSESSMENT OF ECONOMIC CONSEQUENCES DUE TO OUTCROSSING AND
ADVENTITIOUS PRESENCE
THE EFSA GUIDANCE DOCUMENT ON RISK ASSESSMENT OF GMOS DOES NOT TAKE INTO
CONSIDERATION THE ECONOMIC EFFECTS OF CULTIVATION OF GENETICALLY
MODIFIED PLANTS AND THEREFORE OFFERS NO GUIDANCE FOR NOTIFIERS AND
ASSESSORS ON THESE ISSUES. HOWEVER SUCH AN ASSESSMENT IS REQUIRED WITH A
VIEW TO THE POTENTIAL EFFECTS OF THE CULTIVATION OF GM PLANTS AND IS IN
LINE WITH THE ISPM-GUIDANCE BY THE INTERNATIONAL STANDARD SETTING BODY
IPPC, WHICH IS RECOGNISED BY THE WTO.
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ACCORDING TO THIS INTERNATIONALLY AGREED GUIDANCE THE ECONOMICAL
CONSEQUENCES OF THE POTENTIAL CULTIVATION OF GM MAIZE MON810 (OR GM
MAIZE T25 RESPECTIVELY) IN AUSTRIA ARE ASSESSED AS FOLLOWS:
CULTIVATION OF GM MAIZE MON810 (OR GM MAIZE T25) IS EXPECTED TO LEAD TO
CROSSFERTILISATION OF OTHER VARIETIES OF MAIZE GROWN ON NEIGHBOURING
PLOTS SPECIFICALLY UNDER THE CONDITIONS OF THE AUSTRIAN AGRICULTURAL
ENVIRONMENT (SEE CHAPTER 2.1 FOR REFERENCE). THIS EFFECT IS RELEVANT
SPECIFICALLY FOR THE GROWERS OF NON-MODIFIED VARIETIES, SPECIFICALLY OF
ORGANICALLY GROWN MAIZE.
IN AUSTRIA AN AMOUNT OF 1.72 MIO TONNES (T) GRAIN MAIZE AND 3.54 MIO T
MAIZE FOR SILAGE WERE PRODUCED IN 2005. AS PART OF THE OVERALL AMOUNT 34
204 T GRAIN MAIZE WAS PRODUCED ACCORDING TO THE PROVISIONS OF ORGANIC
AGRICULTURE (BMLFUW, 2007). MAIZE FOR PRODUCTION OF GRAINS AND COB-CORN
MIX (CCM) WAS PLANTED ON 181 196 HA, MAIZE FOR SILAGE ON 78 655 HA. FOR
CERTIFIED ORGANIC PRODUCTION 6 024 HA WERE PLANTED TO PRODUCE GRAIN AND
CCM MAIZE, 1 664 HA FOR PRODUCTION OF SILAGE MAIZE.
IN AUSTRIA ADDITIONALLY 4 306 HA OF THE MAIZE PRODUCTION AREA WERE
DEDICATED TO THE PRODUCTION OF MAIZE SEEDS IN 2006. IN THE SAME YEAR
ORGANIC MAIZE SEEDS WERE PRODUCED ON 165 HA. IN SOME REGIONS OF AUSTRIA
THE PRODUCTION OF SEEDS AND THE PRODUCTION OF MAIZE FOR CONSUMPTION ARE
SITUATED IN CLOSE NEIGHBOURHOOD.
SPECIFIC DATA FOR UPPER AUSTRIA AS AN EXAMPLE OF A REGION WITH A HIGH
PROPORTION OF MAIZE PRODUCTION THE TOTAL ACREAGE FOR MAIZE ARE SUPPLIED
IN THE FOLLOWING:
IN 2006 MAIZE WAS GROWN ON 66 777 HA WITH 414 478 T GRAIN AND CCM
MAIZE AND 1 111 085 T MAIZE SILAGE PRODUCED (BMLFUW, 2007). IN 2004 AN
AREA OF 21 379 HA WAS CULTIVATED WITH FIELD CROPS ACCORDING TO ORGANIC
STANDARDS (AT 2 386 FARMS). MOST OF THE FARMS ARE QUITE SMALL WITH LESS
THAN 5 HA
ARABLE LAND/FARM. ORGANIC MAIZE WAS CULTIVATED AT 142 FARMS ON 551 HA
(AVERAGE ACREAGE OF 3.9 HA/FARM). ABOUT 1 000 HA OF MAIZE WERE PLANTED
2004 UNDER SPECIFIC CONTRACTS AS CERTIFIED
GM-FREE PRODUCE FOR THE PRODUCTION OF 10 000 T MAIZE FOR PRODUCTION OF
STARCH IN UPPER AUSTRIA. PRODUCTION OF SPECIALITY MAIZE WAS ALSO ONGOING
IN THE FOLLOWING YEARS.
FOR THE PRODUCTION OF SEEDS AS WELL AS FOR THE ORGANICALLY PRODUCED
MAIZE AND GMO-FREE MAIZE THE THRESHOLD LEVEL FOR ADVENTITIOUS PRESENCE
OF GM MAIZE IS SET TO 0.1 %, BEING THE TECHNICAL LIMIT FOR DETECTION OF
GM PRESENCE (BMLFUW 2001; CODEX ALIMENTARIUS AUSTRIACUS 1998).
THE DIFFERENCE IN PRICES FOR ORGANICALLY GROWN MAIZE VERSUS CONVENTIONAL
MAIZE IS 157 EURO/T (395 EURO/T VS. 238 EURO/T) AS OF OCTOBER 2007
(RAIFFEISEN WARE AUSTRIA). THIS DIFFERENCE IN CURRENT PRICES IS
SUBSTANTIAL FOR THE PRODUCERS: A 40 % LOSS OF INCOME ON SALES HAS TO BE
EXPECTED IN CASE THE INDICATED THRESHOLDS FOR GM-FREE PRODUCE (INCLUDING
ORGANIC PRODUCE) ARE EXCEEDED AS A CONSEQUENCE OF OUT-CROSSING FROM GM
MAIZE MON810. A COMPARABLE DIFFERENCE DOES EXIST BETWEEN MAIZE THAT CAN
BE SOLD AS SEED AND MAIZE SOLD FOR CONSUMPTION PURPOSES. THEREFORE ANY
PRODUCERS OF SEED, ORGANICALLY PRODUCED MAIZE AND PRODUCERS OF SPECIAL
PRODUCE, WHICH IS CERTIFIED TO BE GMO-FREE WILL ACCRUE SEVERE LOSSES OF
INCOME IN CASE THE PRESENCE OF GM MAIZE IN THEIR PRODUCE EXCEEDS A
MARGIN OF 0.1 %.
WITH THE CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 THE FEASIBILITY
FOR PRODUCTION OF GM-FREE MAIZE WILL CERTAINLY BECOME INCREASINGLY
DIFFICULT AND COSTLY. ADDITIONALLY TO ANY UNEXPECTED LOSS OF INCOME IN
CASE OF CONTAMINATION OF PRODUCE THROUGH OUT-CROSSING FROM NEIGHBOURING
FIELDS THE EXPENSES FOR QUALITY-CONTROL OF ORGANIC FARMERS WILL
CERTAINLY RISE. TO GIVE A REPRESENTATIVE EXAMPLE FOR THE COSTS THAT HAVE
TO BE TAKEN INTO ACCOUNT FOR THE SCREENING OF PRODUCE FOR CONTENT OF
GM-MAIZE INCLUDING GM MAIZE MON810 OR GM MAIZE
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T25, RESPECTIVELY: SUCH ANALYSES FOR DETECTION OF GM MAIZE CURRENTLY
COST 195 EURO/SAMPLE AT THE TESTING FACILITY OF THE AUSTRIAN FEDERAL
ENVIRONMENT AGENCY (UMWELTBUNDESAMT 2007). PRICES IN OTHER FACILITIES
ARE COMPARABLE BY A MARGIN OF 20 %. DEMAND FOR ANALYTICAL DETECTION TO
CERTIFY THAT THE PRODUCE IS MEETING THE REQUIRED STANDARDS IS EXPECTED
TO INCREASE SUBSTANTIALLY.
FURTHERMORE IT WILL BE NECESSARY TO INTRODUCE ADDITIONAL PROCEDURES TO
AVOID CONTAMINATION OF PRODUCE AT HARVEST AND AFTERWARDS ONCE GM MAIZE
MON810 OR GM MAIZE T25 ARE CULTIVATED: CLEANING PROCEDURES FOR
HARVESTERS AND OTHER NECESSARY MACHINERY INVOLVED IN
HARVEST AND TRANSPORT, SPECIFIC SEGREGATION SYSTEMS FOR SHIPMENT AND
STORAGE FOR MAIZE CROPS SUCH ADDITIONAL MEASURES WILL CERTAINLY LEAD TO
LOSS OF PRODUCTION OF GMOFREE PRODUCE AS WELL AS ADDITIONAL RELEVANT
EXPENSES FOR SETUP AND MAINTAINING SUCH MEASURES AS SHOWN BY MERTENS &
SCHIMPF (2006). SIMILAR SUBSTANTIAL COSTS HAVE TO BE EXPECTED IN THE
AUSTRIAN CONDITIONS.
IN CONCLUSION THE CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 ON
PLOTS DISTRIBUTED THROUGHOUT AUSTRIA WILL HAVE SEVERE AND DRAMATIC
ECONOMIC CONSEQUENCES FOR THE PRODUCERS OF GM-FREE MAIZE AND MAIZE SEED.
IN CASE CONTAMINATION LEVELS SHOULD APPROACH THE 0.9 % THRESHOLD, THE
PRODUCE WOULD HAVE TO BE LABELLED AS GM-MATERIAL LEADING TO FURTHER
ECONOMIC CONSEQUENCES. THE ASSESSMENT THUS SHOWS THAT ADOPTION OF
CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 IN AUSTRIA WILL VERY
LIKELY HAVE SEVERE ECONOMIC CONSEQUENCES.
4. ENVIRONMENTAL MONITORING PLAN
THIS CHAPTER COVERS ISSUES RELATED TO AN ENVIRONMENTAL MONITORING PLAN
AS OUTLINED IN THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.10.
THESE ISSUES FOR RISK ASSESSMENT CORRESPOND TO THE GUIDANCE FOR
MONITORING OF DELIBERATE RELEASES OF GMOS AND THE PLACING ON THE MARKET
AS DETAILED IN DIR. 2001/18/EC, ANNEX VII. INDIVIDUAL REFERENCE FOR THE
ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN BELOW AND INDICATED
IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED BY EFSA.
4.1 GENERAL ASPECTS (D 10.1)
ACCORDING TO DIRECTIVE 2001/18/EC EACH NOTIFICATION OF A GMO MUST
CONTAIN A PLAN FOR MONITORING IN ACCORDANCE WITH ANNEX VII WITH THE AIM
TO CONFIRM THE ASSUMPTIONS FROM THE RISK ASSESSMENT AND TO IDENTIFY THE
OCCURRENCE OF ADVERSE EFFECTS OF THE GMO OR ITS USE ON HUMAN HEALTH OR
THE ENVIRONMENT WHICH WERE NOT ANTICIPATED IN THE RISK ASSESSMENT.
HOWEVER, A MONITORING PLAN ACCORDING TO THE MENTIONED STANDARDS HAS NOT
BEEN PROVIDED BY THE NOTIFIER. SPECIFICALLY THE ABSENCE OF EFFECTS ON
NON-TARGET ORGANISMS, WHICH WAS STATED BY THE NOTIFIER IN THE RISK
ASSESSMENT, AS WELL AS THE POSSIBLE OCCURRENCE OF SECONDARY PESTS SHOULD
BE SUBJECT TO A MONITORING IN LINE WITH THE REQUIREMENTS LAID DOWN IN
DIRECTIVE 2001/18/EC AS WELL AS THE GUIDANCE BY THE EFSA GMO PANEL.
4.2 CASE-SPECIFIC GM PLANT MONITORING (D.10.3)
THE MAIN OBJECTIVE OF CASE-SPECIFIC MONITORING IS TO DETERMINE THE
SIGNIFICANCE OF ANY ADVERSE EFFECTS IDENTIFIED IN THE ENVIRONMENTAL RISK
ASSESSMENT. IN THIS RESPECT THE LACK OF A MONITORING PLAN FOR
CULTIVATION OF GM MAIZE MON810 TAKING INTO ACCOUNT THE CONDITIONS FOR
USE AND CULTIVATION IN AUSTRIA ARE CONSIDERED A MAIN DEFICIENCY.
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FIRSTLY THIS CONFLICTS WITH THE CURRENT OBLIGATIONS FOR SUCH PRODUCTS.
ANNEX VII OF DIRECTIVE 2001/18/EC MUST BE CONSIDERED AS AGREED MINIMUM
STANDARD FOR THIS ISSUE. ON THE OTHER HAND, SUCH A MONITORING SCHEME
WOULD BE NECESSARY TO ADDRESS THE ISSUE OF SECONDARY PESTS, A QUESTION
CONSIDERED IMPORTANT BY THE SCIENTIFIC COMMITTEE ON PLANTS IN THEIR
OPINION ON THE SAFEGUARD MEASURE FOR GM MAIZE MON810, BUT NOT TAKEN INTO
ACCOUNT ADEQUATELY IN THE PRECEDING ASSESSMENTS.
THE PRESENTED RISK ASSESSMENT IDENTIFIED TWO KINDS OF POTENTIALLY
ADVERSE EFFECTS ON THE ENVIRONMENT THAT HAVE TO BE COVERED IN AN
ADEQUATE CASE-SPECIFIC MONITORING STRATEGY:
POTENTIAL RESISTANCE DEVELOPMENT OF TARGET INSECT SPECIES AND
EFFECTS ON NON-TARGET ORGANISMS IN DIFFERENT HABITATS.
ADDITIONALLY RECENT INVESTIGATIONS OF BT COTTON CULTIVATION IN CHINA
HAVE SHOWN AN EXTRAORDINARY INCREASE OF OTHER PEST SPECIES SUCH AS LEAF
BUGS (WU ET AL. 2002) AND CONSEQUENTLY A RISE IN PESTICIDE APPLICATIONS
(WANG ET AL. 2006). HOWEVER, SECONDARY PESTS WERE NEITHER CONSIDERED IN
THE RISK ASSESSMENT NOR IN A MONITORING PLAN. THEREFORE THE EFFECTS OF
BT CROP CULTIVATION ON OTHER PESTS AND THE DEVELOPMENT OF SECONDARY
PESTS AND CONSEQUENTLY THE ADDITIONAL USE OF SYNTHETIC PLANT PROTECTION
PRODUCTS SHOULD BE MONITORED FOR APPLICATIONS OF BT CROPS.
4.3 GENERAL SURVEILLANCE OF THE IMPACT OF THE GM PLANT (D.10.4)
IN ADDITION TO THE CASE SPECIFIC MONITORING A GENERAL SURVEILLANCE PLAN
IS NECESSARY ACCORDING TO DIR. 2001/18/EC, ANNEX VII AS WELL AS
ACCORDING TO GUIDANCE BY THE EFSA GMO PANEL. THE PLAN SHOULD BE DIRECTED
TO IDENTIFY ANY UNEXPECTED ADVERSE EFFECTS OF THE APPLICATION OF GM
MAIZE MON810 IN ADDITION TO EFFECTS COVERED BY CASE SPECIFIC MONITORING.
THE LACK OF A DETAILED AND EFFECTIVE GENERAL SURVEILLANCE PLAN MUST BE
REGARDED A MAJOR DEFICIENCY OF THE APPLICATION AND INADEQUATE WITH A
VIEW TO ADDRESSING THE CONCERNS THAT HAVE BEEN PUT FORWARD AGAINST THIS
APPLICATION.
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THURINGIENSIS (BT) CORN RESIDUES AND BT-CORN PLANTS AFFECT LIFE-HISTORY
TRAITS IN THE EARTHWORM APORRECTODEA CALIGINOSA? APPLIED SOIL ECOLOGY,
32, 180-187.
VOJTECH E., MEISSLE M., POPPY, G.M. (2005). EFFECTS OF BT MAIZE ON THE
HERBIVORE SPODOPTERA LITTORALIS (LEPIDOPTERA: NOCTUIDAE) AND THE
PARASITOID COTESIA MARGINIVENTRIS (HYMENOPTERA: BRACONIDAE). TRANSGENIC
RES. 14: 133-144.
WANDELER, H., BAHYLOVA, J. NENTWIG, W. (2002). CONSUMPTION OF TWO BT AND
SIX NON-BT CORN VARIETIES BY THE WOODLOUSE PORCELLIO SCABER. BASIC APPL.
ECOL. 3, 357-365.
WANG S., JUST D.R., PINSTRUP-ANDERSEN, P. (2006). TARNISHING SILVER
BULLETS: BT TECHNOLOGY ADOPTION, BOUNDED RATIONALITY AND THE OUTBREAK OF
SECONDARY PEST INFESTATIONS IN CHINA. SELECTED PAPER PREPARED FOR
PRESENTATION AT THE AMERICAN AGRICULTURAL ECONOMICS ASSOCIATION ANNUAL
MEETING LONG BEACH, CA, JULY 22-26, 2006.
WTO (2006): EUROPEAN COMMUNITIES: MEASURES AFFECTING THE APPROVAL AND
MARKETING OF BIOTECH PRODUCTS (DS291, DS292, DS293). FINAL REPORT OF THE
PANEL; ANNEX H (REPLIES BY THE SCIENTIFIC EXPERTS ADVISING THE PANEL TO
THE QUESTIONS POSED BY THE PANEL);
HTTP://WWW.WTO.ORG/ENGLISH/NEWS_E/NEWS06_E/291R_E.HTM
WU K., LI W., FENG H., GUO Y. (2002). SEASONAL ABUNDANCE OF THE MIRIDS,
LYGUS LUCORUM AND ADELPHOCORIS SPP. (HEMIPTERA: MIRIDAE) ON BT COTTON IN
NORTHERN CHINA. CROP PROT. 21: 997-1002.
ZWAHLEN C. & D. ANDOW (2005). FIELD EVIDENCE FOR THE EXPOSURE OF GROUND
BEETLES TO CRY1AB FROM TRANSGENIC CORN. ENVIRON. BIOSAFETY RES. 4:
113-117.
ZWAHLEN, C., HILBECK, A., HOWALD, R.; NENTWIG, W. (2003A). EFFECTS OF
TRANSGENIC BT CORN LITTER ON THE EARTHWORM LUMBRICUS TERRESTRIS. MOLEC.
ECOL. 12: 1077-1086.
ZWAHLEN, C.; HILBECK A.; GUGERLI P.; NENTWIG, W. (2003B). DEGRADATION OF
THE CRY1AB PROTEIN WITHIN TRANSGENIC BACILLUS THURINGIENSIS CORN TISSUE
IN THE FIELD. MOL. ECOL. 12: 765775.
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DAS ZIEL DIESES BERICHTS IST, DIE OESTERREICHISCHEN ARGUMENTE IM WTO-FALL
EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS ZUSAMMEN ZU FASSEN. DIE OESTERREICHISCHEN
SCHUTZKLAUSELN, MIT DENEN DER IMPORT UND DIE ANWENDUNG DER GENTECHNISCH
VERAENDERTEN MAISLINIEN MON810 UND T25 VERBOTEN WIRD, WAREN TEIL DER
BEKLAGTEN EU-MASSNAHMEN IM GENANNTEN STREITFALL. DIESER BERICHT ERFUELLT
DIE WTO KRITERIEN HINSICHTLICH DER FORDERUNG, DASS DIESE MASSNAHMEN AUF
EINER RISIKOABSCHAETZUNG BASIEREN MUESSEN, DIE DEM SPS ABKOMMEN ENTSPRICHT
UND NACH RICHTLINIEN VON INTERNATIONALEN STANDARDISIERUNGSORGANISATIONEN
DURCHGEFUEHRT WURDE.
BESTELLTELEFON: 01/711 00-4700
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| adam_txt |
IMAGE 1
REPORT
SUPPLEMENTARY RISK ASSESSMENT FOR GM MAIZE MON 810 WITH REGARD TO THE
CONCLUSIONS OF THE WTOPANEL IN THE CASE *EC BIOTECH" ON AUSTRIAN
SAFEGUARD MEASURES FOR GM MAIZE
FORSCHUNGSBERICHTE DER SEKTION IV
BAND 4/2007
IMAGE 2
REPORT
SUPPLEMENTARY RISK ASSESSMENT FOR GM MAIZE MON 810 WITH REGARD TO THE
CONCLUSIONS OF THE WTOPANEL IN THE CASE *EC BIOTECH" ON AUSTRIAN
SAFEGUARD MEASURES FOR GM MAIZE
FORSCHUNGSBERICHTE DER SEKTION IV
BAND 4/2007
IMAGE 3
IMPRESSUM:
HERAUSGEBER, MEDIENINHABER UND HERSTELLER: BUNDESMINISTERIUM FUER
GESUNDHEIT, FAMILIE UND JUGEND, SEKTION IV RADETZKYSTRASSE 2, 1031 WIEN
FUER DEN INHALT VERANTWORTLICH: BL MAG. ULRICH HERZOG
ERSCHEINUNGSTERMIN : DEZEMBER 2007
AUTOREN: DR. MICHAEL ECKERSTORFER DR. ANDREAS HEISSENBERGER DR. HELMUT
GAUGITSCH
DRUCK: KOPIERSTELLE DES BMGFJ, RADETZKYSTRASSE 2, 1031 WIEN
BESTELLMOEGLICHKEITEN: TELEFON: +43-1/711 00-4700 DW FAX: +43-1/715 58 30
E-MAIL: BROSCHUERENSERVICE.BMGFJ@BMGFJ.GV.AT INTERNET:
HTTP://WWW.BMGFJ.GV.AT
ISBN 978-3-902611-07-9
DIESE STUDIE/BROSCHUERE IST KOSTENLOS BEIM BUNDESMINISTERIUM FUER
GESUNDHEIT, FAMILIE UND JUGEND, RADETZKYSTRASSE 2, 1031 WIEN, ERHAELTLICH.
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REPORT
SUPPLEMENTARY RISK ASSESSMENT
FOR GM MAIZE MON 810 WITH REGARD
TO THE CONCLUSIONS OF THE WTO-PANEL IN
THE CASE *EC BIOTECH"
ON AUSTRIAN SAFEGUARD MEASURES FOR
GM MAIZE
MICHAEL ECKERSTORFER
ANDREAS HEISSENBERGER
HELMUT GAUGITSCH
VIENNA, 20 NOVEMBER 2007
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CONTENT
CONTENT.
2
SUMMARY
.
3
ZUSAMMENFASSUNG
.
5
INTRODUCTION.
7
HISTORICAL
OVERVIEW.
7
ARGUMENTS TO SUPPORT THE AUSTRIAN POSITION
. 9
INSUFFICIENT SCIENTIFIC DATA
.
9
THE AUSTRIAN ARGUMENTS
.
9
THE SCP STATEMENTS
.10
THE EFSA
OPINION.10
ARGUMENTS BY THE EUROPEAN COMMISSION
.11
THE OPINION OF AN ADVISOR TO THE WTO
PANEL.12
CONCLUSIONS.12
REMARKS WITH REGARD TO MAIZE
T25.13
COMPETING RISK
ASSESSMENT.14
1. INFORMATION ON ANY TOXIC, ALLERGENIC OR OTHER HARMFUL EFFECTS ON
HUMAN OR ANIMAL HEALTH ARISING FROM THE GM
FOOD/FEED.14
1.1 COMPARATIVE ASSESSMENT
(D.7.1).14
1.2 TOXICOLOGY
(D.7.8).15
1.3. ALLERGENICITY (D.7.9)
.15
1.4. MAIZE T25 - HEALTH
ASPECTS.16
2. POTENTIAL CHANGES IN THE INTERACTIONS OF THE GM PLANT WITH THE BIOTIC
ENVIRONMENT RESULTING FROM THE GENETIC
MODIFICATION.16
2.1 POTENTIAL FOR GENE TRANSFER
(D.9.3).17
2.2 INTERACTIONS BETWEEN THE GM PLANT AND TARGET ORGANISMS (D.9.4)
.18 2.3 INTERACTIONS OF THE GM PLANT WITH NON-TARGET
ORGANISMS (D.9.5) .19 3. ASSESSMENT OF ECONOMIC
CONSEQUENCES DUE TO OUTCROSSING AND ADVENTITIOUS
PRESENCE.23
4. ENVIRONMENTAL MONITORING
PLAN.25
4.1 GENERAL ASPECTS (D
10.1).25
4.2 CASE-SPECIFIC GM PLANT MONITORING
(D.10.3).25
4.3 GENERAL SURVEILLANCE OF THE IMPACT OF THE GM PLANT
(D.10.4).26
REFERENCES.26
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SUMMARY
THIS REPORT AIMS TO SUMMARIZE THE AUSTRIAN ARGUMENTS AS A REACTION TO
THE RULING OF THE WTO PANEL ESTABLISHED TO EXAMINE THE DISPUTE CASE
"EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS". PART OF THE ALLEGED MEASURES WERE THE AUSTRIAN
SAFEGUARD CLAUSES WHICH PROHIBIT THE IMPORT AND USE OF THE GENETICALLY
MODIFIED MAIZE LINES MON810 AND T25. THIS REPORT THEREFORE FULFILS THE
WTO REQUIREMENTS TO BASE ANY MEASURES ON A RISK ASSESSMENT IN LINE WITH
SPS PROVISIONS AND ACCORDING TO GUIDANCE BY INTERNATIONAL STANDARD
SETTING BODIES.
THE REPORT IS STRUCTURED IN TWO MAIN PARTS: 1) EVIDENCE THAT THE
AVAILABLE DATA WERE INSUFFICIENT AND DID NOT ALLOW A COMPREHENSIVE
RISK-ASSESSMENT. 2) A RISK ASSESSMENT IN ORDER TO SUPPLEMENT THE
AUSTRIAN ARGUMENTATION AND TO FULFIL
THE REQUIREMENTS OF THE SPS AGREEMENT.
THIS REPORT SHOWS THAT THE OPINION OF AUSTRIA WITH RESPECT TO THE LACK
OF DATA WAS SUPPORTED AT LEAST PARTLY BY THE SCIENTIFIC COMMITTEE ON
PLANTS, THE EUROPEAN COMMISSION AND ONE OF THE EXPERTS CHOSEN BY THE WTO
PANEL TO PROVIDE THEM WITH SCIENTIFIC INFORMATION REGARDING THE DISPUTE
CASE.
THE RISK ASSESSMENT FOR MAIZE MON810 INCLUDED IN THIS REPORT EXAMINES
POSSIBLE EFFECTS ON TARGET AND NON-TARGET ORGANISMS AS WELL AS THE
POTENTIAL FOR GENE TRANSFER AND OTHER RELEVANT RISK ASSESSMENT
PARAMETERS.
WITH REGARD TO GM MAIZE MON810 THE RESULTS OF THE ASSESSMENT OF
INFORMATION PROVIDED BY THE NOTIFIER FOR MON810 AND RECENT SCIENTIFIC
INFORMATION WERE AS FOLLOWS:
O THE CONCLUSIONS DRAWN BY THE NOTIFIER WITH REGARD TO OUT-CROSSING AND
GENETRANSFER ARE BASED ON A "BEST CASE" SCENARIO, RATHER THAN TAKING
REALISTIC DATA AND THE HIGHLY VARIABLE RESULTS FROM DIFFERENT SCIENTIFIC
PUBLICATIONS INTO ACCOUNT.
O THE INSECT RESISTANCE MANAGEMENT PLAN IS INSUFFICIENT BECAUSE THERE IS
NO INFORMATION ON BASELINE DATA, A LACK OF INFORMATION REGARDING THE
IMPLEMENTATION AND A QUESTIONABLE ASSUMPTION WITH REGARD TO THE ADOPTION
SPEED OF GM MAIZE MON810 IN THE EUROPEAN UNION, WHICH WAS ESTIMATED TO
BE UNREALISTICALLY LOW.
O IT IS CLEARLY SHOWN THAT THERE IS A RISK TO NON-TARGET ORGANISMS. THIS
CONCLUSION IS BASED ON THE SCIENTIFIC LITERATURE AND DATA RELEVANT FOR
THE AUSTRIAN SITUATION, LIKE POPULATION DENSITIES OF LEPIDOPTERA IN
AGRICULTURAL ENVIRONMENTS, INCLUDING MAIZE FIELDS, AND THEIR
CLASSIFICATION AS "ENDANGERED SPECIES". AS IT HAS BEEN SHOWN THAT
BT-TOXINS ALSO AFFECT NON-TARGET LEPIDOPTERAN SPECIES, IT IS LIKELY THAT
THE USE OF BTPLANTS WILL NEGATIVELY AFFECT POPULATIONS OF LEPIDOPTERA
LIVING IN AGRICULTURAL ENVIRONMENTS. AQUATIC NON-TARGET ORGANISMS, LIKE
TRICHOPTERA ARE ALSO LIKELY TO BE NEGATIVELY AFFECTED, ACCORDING TO NEW
SCIENTIFIC RESULTS.
O THE ASSUMPTIONS MADE BY THE APPLICANT CONCERNING TOXICOLOGICAL AND
ALLERGENIC PROPERTIES OF MON810 MAIZE ARE BASED ON ACUTE TOXICITY
STUDIES USING ISOLATED, BACTERIAL DERIVED PROTEINS, AS WELL AS HOMOLOGY
AND IN-VITRO DIGESTIBILITY STUDIES. THIS CANNOT BE CONSIDERED SUFFICIENT
AS THERE MAY BE STRUCTURAL DIFFERENCES BETWEEN PLANT- AND
BACTERIA-DERIVED PROTEINS; ANY CHRONIC AD SUB-CHRONIC EFFECTS CANNOT BE
ASSESSED BY THE APPROACH USED.
O THE SET OF PARAMETERS ASSESSED FOR COMPOSITIONAL ANALYSIS IS VERY
NARROW AND DOES NOT FOLLOW INTERNATIONAL GUIDELINES. EVEN THE RESULTS
SHOWING SIGNIFICANT DIFFERENCES TO NON-GM-PLANTS DID NOT LEAD TO FURTHER
INVESTIGATION.
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THE RISK ASSESSMENT FOR GM MAIZE T25 IS ALSO ADDRESSED, BUT IN A LESS
DETAILED MANNER. NEVERTHELESS IT CAN BE CONCLUDED THAT THE RISK
ASSESSMENT PROVIDED BY THE APPLICANT DOES NOT TAKE IN TO ACCOUNT ALL
RELEVANT ISSUES ACCORDING TO THE STATE-OF-THE-ART OF SCIENTIFIC
KNOWLEDGE.
IN ADDITION TO THE STANDARD RISK ASSESSMENT PARAMETERS AN ESTIMATION ON
THE POSSIBLE ECONOMIC CONSEQUENCES FOR ORGANIC AND CONVENTIONAL FARMERS
IS GIVEN. THIS ASSESSMENT IS IN LINE WITH THE ISPM-GUIDANCE BY THE
STANDARD SETTING BODY IPPC WHICH IS RECOGNIZED BY THE WTO. A LIKELY
DECREASE IN THE INCOME OF ORGANIC AND CONVENTIONAL FARMERS IS CAUSED BY
OUT-CROSSING FROM GM-MAIZE FIELDS AND THE CONSEQUENTIALLY DECREASED
VALUE OF THEIR HARVEST.
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ZUSAMMENFASSUNG
DAS ZIEL DIESES BERICHTS IST, DIE OESTERREICHISCHEN ARGUMENTE IM WTO-FALL
"EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS" ZUSAMMEN ZU FASSEN. DIE OESTERREICHISCHEN
SCHUTZKLAUSELN, MIT DENEN DER IMPORT UND DIE ANWENDUNG DER GENTECHNISCH
VERAENDERTEN MAISLINIEN MON810 UND T25 VERBOTEN WIRD, WAREN TEIL DER
BEKLAGTEN EU-MASSNAHMEN IM GENANNTEN STREITFALL. DIESER BERICHT ERFUELLT
DIE WTO KRITERIEN HINSICHTLICH DER FORDERUNG, DASS DIESE MASSNAHMEN AUF
EINER RISIKOABSCHAETZUNG BASIEREN MUESSEN, DIE DEM SPS ABKOMMEN ENTSPRICHT
UND NACH RICHTLINIEN VON INTERNATIONALEN STANDARDISIERUNGSORGANISATIONEN
DURCHGEFUEHRT WURDE.
DIESER BERICHT IST IN ZWEI THEMATISCHE BEREICHE GETEILT: 1. EINE
ARGUMENTATION, DASS DIE ZUR VERFUEGUNG STEHENDEN DATEN NICHT AUSREICHEND
WAREN, UM EINE UMFASSENDE RISIKOABSCHAETZUNG DURCHFUEHREN ZU KOENNEN. 2.
EINE ERGAENZENDE RISIKOABSCHAETZUNG UM DIE OESTERREICHISCHEN ARGUMENTE ZU
VERVOLLSTAENDIGEN UND DIE ANFORDERUNGEN NACH DEM SPS ABKOMMEN ZU
ERFUELLEN.
DIESER BERICHT ZEIGT, DASS DIE MEINUNG OESTERREICHS IN BEZUG AUF DAS
FEHLEN VON DATEN ZUR RISIKOABSCHAETZUNG ZUMINDEST TEILWEISE VOM
WISSENSCHAFTLICHEN KOMITEE FUER PFLANZEN DER EU, DER EUROPAEISCHEN
KOMMISSION UND EINEM DER WISSENSCHAFTLICHEN EXPERTEN, DIE VOM WTO-PANEL
ZU DESSEN UNTERSTUETZUNG HERANGEZOGEN WURDEN, GETEILT WIRD.
DIE IN DIESEM BERICHT VORGELEGTE RISIKOABSCHAETZUNG FUER MON810 MAIS
BEHANDELT MOEGLICHE EFFEKTE AUF ZIEL- UND NICHT-ZIELORGANISMEN SOWIE
MOEGLICHEN GENTRANSFER UND ANDERE RELEVANTE PARAMETER DER
RISIKOABSCHAETZUNG.
FUER MON810 KANN MIT BEZUG AUF DIE VOM ANTRAGSTELLER ZUR VERFUEGUNG
GESTELLTEN INFORMATIONEN UND NEUERE WISSENSCHAFTLICHE ERKENNTNISSE
FOLGENDES FESTGESTELLT WERDEN:
O DIE SCHLUSSFOLGERUNGEN DES ANTRAGSTELLERS IN BEZUG AUF AUSKREUZUNG UND
GENTRANSFER BERUHEN AUF EINEM *BEST CASE"-SZENARIO, UND BASIEREN NICHT
AUF REALISTISCHEN DATEN UND DEN SEHR VARIABLEN RESULTATEN AUS DEN
VERFUEGBAREN WISSENSCHAFTLICHEN PUBLIKATIONEN.
O DER RESISTENZMANAGEMENTPLAN FUER DEN MAISZUENSLER IST UNZUREICHEND DA
KEINE ANGABE VON BASISDATEN ERFOLGTE, DIE INFORMATION BEZUEGLICH DER
UMSETZUNG DIESES PLANS UNZUREICHEND IST UND EINE UNREALISTISCHE, D.H.
VIEL ZU NIEDRIGE, ANNAHME BEZUEGLICH DER GESCHWINDIGKEIT DER EINFUEHRUNG
VON MON810 IN DER EU GETROFFEN WURDE.
O ES KONNTE KLAR GEZEIGT WERDEN, DASS EIN RISIKO FUER
NICHT-ZIELORGANISMEN BESTEHT. DIESES ERGEBNIS BERUHT AUF
WISSENSCHAFTLICHER LITERATUR UND FUER OESTERREICH RELEVANTE DATEN, WIE
Z.B. POPULATIONSDICHTEN VON LEPIDOPTEREN (SCHMETTERLINGEN) IN
LANDWIRTSCHAFTLICHEN OEKOSYSTEMEN UND MAISFELDERN SOWIE DEREN
GEFAEHRDUNGSKLASSIFIZIERUNG. DA GEZEIGT WURDE, DASS BT-TOXINE AUCH
EFFEKTE AUF NICHTZIELLEPIDOPTEREN HABEN, IST ES WAHRSCHEINLICH, DASS
LEPIDOPTERENPOPULATIONEN IN LANDWIRTSCHAFTLICHEN OEKOSYSTEMEN NEGATIV
BEEINFLUSST WERDEN. NACH NEUESTEN WISSENSCHAFTLICHEN ERKENNTNISSEN
KOENNEN AUCH AQUATISCHE NICHT-ZIELORGANISMEN, WIE TRICHOPTEREN
(KOECHERFLIEGEN) DURCH BT-TOXINE GESCHAEDIGT WERDEN.
O DIE SCHLUSSFOLGERUNGEN DES ANTRAGSTELLERS HINSICHTLICH DER TOXISCHEN
UND ALLERGENEN EIGENSCHAFTEN VON MON810 MAIS BASIEREN AUF
AKUT-TOXIZITAETSTESTS, DIE MIT AUS BAKTERIEN GEWONNENEM ISOLIERTEN
PROTEIN DURCHGEFUEHRT WURDEN, SOWIE AUF HOMOLOGIESTUDIEN UND IN-VITRO
ABBAUSTUDIEN. DIES KANN NICHT ALS AUSREICHEND ANGESEHEN WERDEN, DA SICH
DAS BAKTERIELLE PROTEIN MOEGLICHERWEISE VOM PFLANZLICHEN UNTERSCHEIDET
UND DURCH DEN VERSUCHSANSATZ CHRONISCHE ODER SUBCHRONISCHE EFFEKTE NICHT
ERFASST WERDEN.
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O DIE ANZAHL DER PARAMETER DIE ZUR UNTERSUCHUNG DER INHALTSSTOFFE
HERANGEZOGEN WURDEN IST NICHT AUSREICHEND UND ENTSPRICHT NICHT DEN
INTERNATIONALEN RICHTLINIEN. AUSSERDEM WURDEN SELBST BEI RESULTATEN DIE
SIGNIFIKANTE UNTERSCHIEDE ZU KONVENTIONELLEN PFLANZEN ZEIGTEN, KEINE
WEITEREN UNTERSUCHUNGEN DURCHGEFUEHRT.
DER GENTECHNISCH VERAENDERTE MAIS T25 WIRD EBENFALLS, ABER WENIGER
DETAILLIERT, BEHANDELT. TROTZDEM KANN FESTGESTELLT WERDEN, DASS DIE VOM
ANTRAGSTELLER VORGELEGTE RISIKOABSCHAETZUNG NICHT DEM STAND DER
WISSENSCHAFT UND TECHNIK ENTSPRICHT.
ZUSAETZLICH ZU DEN STANDARDPARAMETERN DER RISIKOABSCHAETZUNG WURDEN AUCH
MOEGLICHE OEKONOMISCHE AUSWIRKUNGEN AUF DIE BIOLOGISCHE UND KONVENTIONELLE
LANDWIRTSCHAFT ABGESCHAETZT. DIESE ABSCHAETZUNG ENTSPRICHT DEN ISPM
RICHTLINIEN DER IPPC, EINEM VON DER WTO ANERKANNTEN STANDARD. SEHR
WAHRSCHEINLICH WUERDE DAS EINKOMMEN VON BIOLOGISCHEN UND KONVENTIONELL
WIRTSCHAFTENDEN LANDWIRTEN AUFGRUND VON AUSKREUZUNG UND DER DAMIT
VERBUNDENEN WERTMINDERUNG IHRER ERNTE SINKEN.
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INTRODUCTION
IN SEPTEMBER 2006 THE WTO-PANEL, WHICH WAS ESTABLISHED TO SETTLE THE
DISPUTE CASE "EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND
MARKETING OF BIOTECH PRODUCTS" BASED ON A COMPLAINT BY THE USA, CANADA
AND ARGENTINA CONCERNING THE AUTHORIZATION OF GMOS AND SEVERAL NATIONAL
SAFEGUARD MEASURES BY EU-MEMBER STATES, PUBLISHED A FINAL REPORT (WTO
2006). IN THIS REPORT IT WAS STATED THAT SOME OF THE ALLEGED MEASURES,
LIKE THE "DE FACTO MORATORIUM" DO NO LONGER EXIST, WHEREAS OTHER
MEASURES, LIKE THE NATIONAL SAFEGUARD CLAUSES, ARE NOT IN LINE WITH THE
REQUIREMENTS LAID DOWN IN THE SPS AGREEMENT.
AFTER CHANGES IN EU AUTHORIZATION PROCEDURE AND THE WITHDRAWAL OF
SEVERAL PRODUCT NOTIFICATIONS AS WELL AS NATIONAL BANS, THE AUSTRIAN
SAFEGUARD CLAUSES REGARDING THE GENETICALLY MODIFIED MAIZE LINES MON810
AND T25 ARE THE ONLY ALLEGED MEASURES STILL IN PLACE.
CONCERNING THE NATIONAL SAFEGUARD MEASURES THE WTO PANEL RECOMMENDED
THAT THESE MEASURES ARE ALSO TO BE BROUGHT INTO CONSISTENCY WITH WTO
AGREEMENTS EITHER BY LIFTING THEM (AS NATIONAL MEASURES OR THROUGH
INVOLVEMENT OF THE EUROPEAN COMMUNITIES), OR BY PROVIDING REVISED RISK
ASSESSMENTS FOR THESE PRODUCTS THAT ARE IN LINE WITH THE SPS PROVISIONS.
IN OCTOBER 2006 THE FEDERAL MINISTRY FOR HEALTH AND WOMEN (NOW FEDERAL
MINISTRY FOR HEALTH, FAMILY AND YOUTH) ALREADY PUBLISHED AN ANALYSIS OF
THE WTO REPORT (ECKERSTORFER ET AL. 2006), WHICH ADDRESSED A NUMBER OF
OPEN QUESTIONS REGARDING THE REASONING OF THE WTO PANEL, SUCH AS
INADEQUACIES OF THE FINAL REPORT OF THE WTO PANEL IN ADDRESSING THE
SUBSTANTIVE JUSTIFICATION OF THE CONCERNS LEADING TO THE ADOPTION OF THE
AUSTRIAN SAFEGUARD MEASURES, THE FAILURE OF THE WTO PANEL TO CONSIDER
INADEQUACIES IN THE RISK ASSESSMENTS BY
THE SCIENTIFIC COMMITTEE ON PLANTS (SCP), WHILE REGARDING THE OPINIONS
OF THE SCP AS FORMAL EVIDENCE THAT SUFFICIENT SCIENTIFIC INFORMATION WAS
AVAILABLE, NOT CONSIDERING UNCERTAINTIES WITH REGARD TO THE LONG-TERM
ENVIRONMENTAL EFFECTS OF HERBICIDE-TOLERANT CROPS, THE EFFECTS OF GMOS
ON NON-TARGET ORGANISMS AND THE
INADEQUACIES OF BT-RESISTANCE MANAGEMENT AND MONITORING DESIGNS, THE
FAILURE OF THE WTO PANEL TO TAKE INTO ACCOUNT THAT REGIONAL ASPECTS WERE
NOT CONSIDERED SUFFICIENTLY.
THIS REPORT AIMS TO PRESENT MORE DETAIL AND - WHERE POSSIBLE - NEW
SCIENTIFIC DATA ON SOME OF THESE OPEN QUESTIONS AND TO SUPPORT THE
AUSTRIAN ARGUMENTATION BY
1) SUMMARIZING THE AUSTRIAN ARGUMENTATION REGARDING INSUFFICIENT
INFORMATION FOR CARRYING OUT A SATISFACTORY RISK ASSESSMENT (ACCORDING
TO ARTICLE 5.7. OF THE SPS AGREEMENT), AND
2) SUPPLEMENTING THE RISK ASSESSMENT CARRIED OUT BY AUSTRIA WITH
ADDITIONAL INFORMATION IN ORDER TO FULFIL THE REQUIREMENTS OF THE SPS
AGREEMENT (AS REFLECTED IN ART. 5.1. OF THE SPS AGREEMENT).
HISTORICAL OVERVIEW
IN MAY 2003 THE USA, CANADA AND ARGENTINA LAUNCHED A DISPUTE WITH THE
EUROPEAN COMMUNITIES ON COMPLAINTS THAT CERTAIN REGULATORY MEASURES OF
THE EUROPEAN COMMUNITIES CONCERNING BIOTECH PRODUCTS ARE NOT IN
CONFORMITY WITH WTO RULES. AS CONSULTATIONS BETWEEN THE COMPLAINING
PARTIES AND THE EC COULD NOT RESOLVE THESE ISSUES, THE THREE COMPLAINING
PARTIES REQUESTED THE ESTABLISHMENT OF A WTO PANEL TO FURTHER EXAMINE
THE MATTERS. FOLLOWING THOSE REQUESTS THE WTO DISPUTE SETTLEMENT BODY
(DSB)
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ESTABLISHED A PANEL TO DEAL WITH THE REQUESTS OF USA, CANADA AND
ARGENTINA IN AUGUST 2003. AFTER SEVERAL MEETINGS AND HEARINGS THE PANEL
DISTRIBUTED THE FINAL REPORT TO WTO MEMBER STATES IN SEPTEMBER 2006. THE
MAIN RESULTS OF THIS REPORT ARE BRIEFLY SUMMARIZED AS FOLLOWS:
MEASURE AT ISSUE WTO PANEL RULING
GENERAL SUSPENSION OF THE EC APPROVAL PROCESSES; "GENERAL DE FACTO
MORATORIUM" ON THE APPROVAL OF BIOTECH PRODUCTS.
A GENERAL DE FACTO MORATORIUM HAS BEEN APPLIED BY THE EC BETWEEN JUNE
1999 AND AUGUST 2003. THE MORATORIUM ITSELF IS NOT AN SPS MEASURE.
IT AFFECTED THE OPERATION AND APPLICATION OF
THE EC APPROVAL PROCEDURES. CURRENTLY NO INDICATIONS THAT
REPERCUSSIONS ARE PENDING FOR EC.
PRODUCT-SPECIFIC MEASURES ; FAILURE TO ADVANCE AND CONCLUDE THE EXISTING
APPROVAL PROCEDURES OF THE EC WITHOUT UNDUE DELAY ACCORDING TO SPS IN 27
CASES (ACCORDING TO DIR. 90/220/EEC OR DIR. 2001/18/EC AND REG. 258/97).
THE EC HAS BREACHED ITS OBLIGATIONS ON 24 (OUT OF 27) SPECIFIC
APPROVAL PROCEDURES. INCONSISTENCIES ONLY ACCORDING TO ANNEX C(1)(A)
AND ART.8 SPS ("UNDUE DELAY"). WHEN APPROVAL PROCEDURES ARE ADVANCED
WITHOUT FURTHER UNDUE DELAY, NO REPERCUSSIONS PENDING.
NATIONAL SAFEGUARD MEASURES BY EU MEMBER STATES; MARKETING OR IMPORT
BANS ON 9 GM-PRODUCTS BY 6 EU COUNTRIES (AUSTRIA, FRANCE, GERMANY,
GREECE, ITALY, LUXEMBOURG).
ALL SAFEGUARD MEASURES ARE NOT BASED ON A RISK ASSESSMENT AS REQUIRED
UNDER ART. 5.1 SPS AND NOT CONSISTENT WITH THE REQUIREMENTS OF ART. 5.7.
SPS.
BY MAINTAINING THESE MEASURES, THE EC HAS ACTED INCONSISTENTLY WITH
ITS OBLIGATIONS UNDER ART. 2.2 SPS.
EXISTENT MEASURES NEED TO BE BROUGHT IN CONFORMITY WITH SPS, OTHERWISE
REPERCUSSIONS ARE PENDING.
THE FIRST TWO ALLEGED MEASURES ARE NO LONGER VALID, AS THE DE-FACTO
MORATORIUM HAS BEEN TERMINATED IN SEPTEMBER 2004 AND ACTION AGAINST ANY
"UNDUE DELAY" HAS BEEN TAKEN BY THE EU BY ESTABLISHING A MORE
STREAMLINED AND CENTRALIZED AUTHORIZATION PROCEDURE ACCORDING TO
REGULATION (EC) 1829/03.
REGARDING THE NATIONAL SAFEGUARD MEASURES THE AUSTRIAN BANS OF GM MAIZE
MON810 AND T25 ARE THE ONLY BANS, WHICH HAVE BEEN CHALLENGED BY THE
COMPLAINING PARTIES AND WHICH ARE STILL IN PLACE. THEREFORE THESE BANS
REMAIN THE ONLY UNSOLVED ISSUE IN THE WTO-DISPUTE "EC-BIOTECH".
THE EUROPEAN COMMISSION TRIED TWICE TO FORCE AUSTRIA TO LIFT ITS BAN BY
PROPOSING SUCH A MEASURE TO THE EUROPEAN COUNCIL (24 JUNE 2005 AND 18
DECEMBER 2006), BUT FAILED BECAUSE THESE PROPOSALS WERE REJECTED BY THE
COUNCIL WITH A QUALIFIED MAJORITY. A THIRD ATTEMPT BY THE EUROPEAN
COMMISSION TO PARTLY LIFT THE AUSTRIAN BANS, RESTRICTING THEM TO BANS
FOR CULTIVATION, COULD NEITHER REACH A QUALIFIED MAJORITY IN FAVOUR OR
AGAINST THE PROPOSAL AT THE COUNCIL ON 30 OCTOBER 2007. THEREFORE IT IS
NOW UP TO THE EUROPEAN COMMISSION TO DECIDE WHETHER THE BANS SHOULD BE
PARTLY LIFTED.
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ARGUMENTS TO SUPPORT THE AUSTRIAN POSITION
INSUFFICIENT SCIENTIFIC DATA ONE OF THE CRUCIAL QUESTIONS WHICH WAS
DISCUSSED DURING THE PANEL MEETINGS AND THE MEETINGS WITH THE
COMPLAINING PARTIES AND THE EC WAS:
IS THE SCIENTIFIC EVIDENCE INSUFFICIENT TO CONDUCT A RISK ASSESSMENT
ACCORDING TO ART. 5.1. OF THE SPS AGREEMENT?
AUSTRIA BASED ITS BANS ON THE LACK OF SCIENTIFIC INFORMATION REGARDING
ENVIRONMENTAL RISK ASSESSMENT, WHICH WAS BACKED BY SCIENTIFIC STUDIES
SHOWING THAT ADVERSE EFFECTS HAVE NOT BEEN CORRECTLY ASSESSED IN THE
INITIAL RISK ASSESSMENT. IN THE COURSE OF THE FOLLOWING YEARS AUSTRIA
PROVIDED EVEN MORE ARGUMENTS AND SCIENTIFIC EVIDENCE COVERING ALSO
HEALTH ASPECTS AS REQUESTED BY THE EUROPEAN COMMISSION. HOWEVER, THE
WTO-PANEL CONCLUDED THAT THERE WAS SUFFICIENT INFORMATION, BASED ON THE
FACT, THAT OTHERWISE THE EC WOULD NOT HAVE APPROVED THE RESPECTIVE GMOS
AND THAT THE SCIENTIFIC BODIES INVOLVED IN THE PROCESS, NAMELY THE
SCIENTIFIC COMMITTEE ON PLANTS (SCP) AND THE EFSA, WOULD NOT HAVE ISSUED
A POSITIVE OPINION.
THE FOLLOWING CHAPTER IDENTIFIES THE CONTRADICTIONS IN THIS
ARGUMENTATION AND WILL SUMMARIZE THE ARGUMENTS, WHY THERE IS STILL
INSUFFICIENT SCIENTIFIC INFORMATION AVAILABLE TO CONDUCT A PROPER RISK
ASSESSMENT.
THE AUSTRIAN ARGUMENTS AFTER CONSENT WAS GIVEN TO THE NOTIFICATION OF GM
MAIZE MON810 IN APRIL 1998 (COMMISSION DECISION 98/294/EC), THE AUSTRIAN
COMPETENT AUTHORITY DECIDED TO PROHIBIT THE PLACING ON THE MARKET OF GM
MAIZE LINE MON810 ON 10 JUNE 1999 AS A SAFEGUARD MEASURE ACCORDING TO
ARTICLE 16 OF DIRECTIVE 90/220/EEC. THE OBJECTION OF AUSTRIA WAS BASED
ON THE FACT THAT THE INFORMATION PROVIDED BY THE APPLICANT WAS NOT
DEEMED SUFFICIENT WITH REGARD TO THE FOLLOWING POINTS OF CONCERN:
A. POSSIBLE UNINTENDED EFFECTS OF THE BT TOXIN ON NON-TARGET INSECTS B.
UNCERTAINTY ABOUT THE EFFECTIVENESS OF THE REFUGE STRATEGY IN ORDER TO
PREVENT THE DEVELOPMENT OF BT RESISTANCE IN THE EUROPEAN CORN BORER. C.
EFFECTS OF OTHER BT PLANTS SUCH AS THE INCREASE OF SECONDARY PESTS AND
CONSEQUENTLY ADDITIONAL USE OF SYNTHETIC PLANT PROTECTION PRODUCTS. D.
UNCERTAINTY ABOUT THE SPECIFICITY OF BT PLANTS
IN A SUBSEQUENT COMMUNICATION TO THE COMMISSION DATED JANUARY 2004 (BMGF
2004A) AUSTRIA REITERATED ITS OBJECTIONS AND RAISED ADDITIONAL CONCERNS
WITH RESPECT TO ALLERGENIC PROPERTIES OF BT PROTEINS RELEVANT FOR GM
MAIZE MON810. FURTHERMORE, GENERAL SHORTCOMINGS IN ALLERGENICITY AND
TOXICITY ASSESSMENT UNDER DIRECTIVE 2001/18/EC AND UNDER THE NOVEL FOOD
REGULATION WERE EMPHASISED. ESPECIALLY, DIGESTIBILITY STUDIES USING
MICROBIAL TEST PROTEINS WERE NOT CONSIDERED APPROPRIATE BECAUSE POST
TRANSLATIONAL MODIFICATION COULD POSSIBLY AFFECT PROTEIN PROPERTIES OR
FUNCTION (DOLEZEL ET AL. 2007). IN ADDITION IT WAS POINTED OUT THAT THE
NUTRITIONAL ANALYSIS PRESENTED IN THE ORIGINAL DOSSIER OF MON810 DOES
NOT FULFIL THE REQUIREMENTS OF THE OECD (OECD 2002), AS SEVERAL
COMPOUNDS, LIKE MINERALS OR VITAMINS WERE NOT ASSESSED.
THE AUSTRIAN BAN FOR GM MAIZE MON810 WAS THEREFORE BASED
ON LACK OF INFORMATION ON ENVIRONMENTAL ISSUES, BECAUSE THEY WERE NOT
PROVIDED BY THE NOTIFIER OR ON SCIENTIFIC EVIDENCE, WHICH WAS
REFERRED TO BY AUSTRIA, BUT WAS NOT TAKEN INTO ACCOUNT WHEN GRANTING THE
CONSENT, AND ON HEALTH ISSUES, BECAUSE THE DATA PROVIDED IN THE
DOSSIER WERE EITHER INCOMPLETE
OR NOT OBTAINED BY USING ADEQUATE METHODS.
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THE SCP STATEMENTS IN ITS FIRST OPINION, WHICH WAS THE BASIS FOR THE
DECISION TO GRANT CONSENT FOR THE PLACING ON THE MARKET OF GM MAIZE
MON810, THE SCP STATED THAT THERE WAS NEITHER A RISK FOR THE ENVIRONMENT
NOR HUMAN OR ANIMAL HEALTH. IT CONSIDERED THE INFORMATION PROVIDED BY
THE APPLICANT AS SUFFICIENT. HOWEVER, THE COMMITTEE ALSO POINTED OUT
THAT "THE OFTEN APPLIED IN VITRO METHODOLOGY USED TO STUDY THE SURVIVAL
OF BTK TOXIN CAN BE IMPROVED. IN PARTICULAR, THE USE OF THE ISOLATED
PROTEIN IN TOXICITY STUDIES DOES NOT ADEQUATELY MODEL DEGRADATION OF THE
SAME PROTEIN WHEN FED AS AN INTEGRAL COMPONENT OF THE DIET ", BUT DID
NOT REQUIRE FURTHER STUDIES.
THE SECOND OPINION OF THE SCP OF 24 SEPTEMBER 1999, WHICH WAS PUBLISHED
AS A REACTION TO THE AUSTRIAN BAN, DID NOT CONSIDER ASPECTS OF HUMAN
HEALTH OR SUBSTANTIAL EQUIVALENCE. THIS WAS IN ACCORDANCE WITH THE SCOPE
OF THE AUSTRIAN SUBMISSION OF 1998, WHICH ONLY RAISED ENVIRONMENTAL
CONCERNS.
WITH REGARD TO THE ENVIRONMENTAL CONCERNS RAISED BY AUSTRIA THE SCP DID
NOT CONSIDER THEM AS JUSTIFIED BUT HOWEVER STATED THAT:
1. WITH RESPECT TO POSSIBLE UNINTENDED EFFECTS ON NON-TARGET INSECTS
RESULTS OF LABORATORY STUDIES WOULD BE DIFFICULT TO INTERPRET AND
EXTRAPOLATE TO FIELD CONDITIONS AND THAT SUCH INTERPRETATION MUST BE
VIEWED AGAINST THE COMPARATIVE RISK ASSESSMENT OF ALTERNATIVE SPRAY
APPLICATIONS OF INSECTICIDES, AND THAT FURTHER WORK WOULD BE NEEDED TO
INVESTIGATE AND VERIFY SUCH EFFECTS IN THE FIELD. 2. WITH RESPECT TO THE
LIMITED SPECIFICITY OF BT PLANTS THE COMMITTEE ADMITTED THAT
GM MAIZE HAS THE POTENTIAL TO BE TOXIC TO CERTAIN SPECIES OF LEPIDOPTERA
AND CONCLUDED THAT THIS ISSUE MUST BE DEALT WITH ON A SPECIES-TO-SPECIES
BASIS .
EVEN IF THE SCP COULD NOT SEE ANY RISK LINKED TO THE PLACING ON THE
MARKET OF MON810 IN ITS FIRST STATEMENT, IT IS HIGHLY IMPORTANT THAT IT
ADMITTED IN ITS REACTION TO THE AUSTRIAN BANS THAT THERE IS A NEED FOR
FURTHER INVESTIGATION OF NEGATIVE EFFECTS ON NON-TARGET ORGANISMS,
ADMITTING, IN OTHER WORDS, THAT THERE IS A LACK OF DATA WITH RESPECT TO
THE ASSESSMENT OF EFFECTS ON NON-TARGET ORGANISMS.
THE EFSA OPINION IN 2004 THE EFSA GMO PANEL RESPONDED TO A REQUEST FROM
THE EUROPEAN COMMISSION AND CONCLUDED THAT THE EVIDENCE PRESENTED BY
AUSTRIA CONTAINED NO NEW GENERIC OR LOCAL SCIENTIFIC INFORMATION ON THE
ENVIRONMENTAL IMPACTS OF THE SPECIFIED MAIZE. IN THE REVIEW OF THE
EVIDENCE PROVIDED BY AUSTRIA EFSA ONLY DISCUSSED EVIDENCE SUBMITTED TO
SUSTAIN AUSTRIA'S ENVIRONMENTAL CONCERNS. THE PANEL DISMISSED THE
EVIDENCE PROVIDED BY AUSTRIA THAT CRITICALLY REVIEWS AND ASSESSES THE
VALIDITY OF TOXICITY ASSESSMENT, ALLERGENICITY ASSESSMENT AND THE
PRACTICE OF SUBSTANTIAL EQUIVALENCE IN A NUMBER OF DIRECTIVE 90/220/EEC
AND NOVEL FOOD DOSSIERS, INCLUDING GM MAIZE MON810 AND T25 MAIZE (SPOEK
ET AL. 2004).
IN 2006 A SECOND OPINION OF THE EFSA GMO PANEL, RELATED TO SEVERAL GM
CROPS SUBJECT TO SAFEGUARD MEASURES, WAS PUBLISHED, FOLLOWING A REQUEST
BY THE COUNCIL OF MINISTERS OF ENVIRONMENT. EFSA EXPLICITLY STATED THAT
IT DID NOT REASSESS THE DOSSIERS OF THE ORIGINAL APPLICATIONS, WHETHER
THEY WOULD COMPLY WITH THE MOST RECENT SAFETY REQUIREMENTS LAID DOWN IN
DIRECTIVE 2001/18/EC, REGULATION (EC) 1829/03 AND THE EFSA GUIDANCE
DOCUMENT, BUT FOCUSED ON THE ARGUMENTS PRESENTED BY THE MEMBER STATES TO
JUSTIFY THEIR SAFEGUARD MEASURES.
IN ITS OPINION EFSA DID NEITHER MENTION ANY NEW EVIDENCE PROVIDED BY
MEMBER STATES FOLLOWING ITS 2004 OPINION, NOR ANY NEW SCIENTIFIC
LITERATURE IN THE PUBLIC DOMAIN. THE PANEL HOWEVER REAFFIRMED ITS
CONCLUSIONS FOR THE PREVIOUS 2004 OPINION.
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ARGUMENTS BY THE EUROPEAN COMMISSION MATERIAL PROVIDED BY THE EUROPEAN
COMMISSION IN THE COURSE OF THE WTO DISPUTE SHOWS THAT THE COMMISSION IS
ACKNOWLEDGING IN SOME CASES THE LACK OF SUFFICIENT SCIENTIFIC
INFORMATION IN GMO RISK ASSESSMENT. IN THE FOLLOWING SOME EXAMPLES OF
THE COMMISSION'S ARGUMENTS ARE PRESENTED (ALL TAKEN FROM WTO 2006). A
MORE DETAILED ANALYSIS IS GIVEN IN ECKERSTORFER ET AL. (2006).
AS A GENERAL OBSERVATION THE COMMISSION STATES THAT:
- SCIENTIFIC AND TECHNICAL KNOWLEDGE IS INCOMPLETE AND THAT THERE IS
LIMITED EXPERIENCE.
- THERE IS "ABSENCE OF AGREED CRITERIA ON MANY ISSUES (IN SCIENTIFIC AND
REGULATORY CIRCLES), INCLUDING WITH RESPECT TO THE INFORMATION NECESSARY
TO PERFORM A RISK ASSESSMENT AND, ALSO, THE MANNER IN WHICH TO INTERPRET
THE RELEVANT DATA."
WITH RESPECT TO THE FUNDAMENTAL CRITICISM OF THE RELIANCE ON ACUTE
TOXICITY TESTING THE COMMISSION, STATED THAT
"[C]ONCERNING THE RESULTS OF THE TOXICOLOGICAL ASSESSMENT OF THE
COMPANIES, IT MUST BE STATED THAT THE COMPREHENSIVE TOXICOLOGICAL RISK
ASSESSMENT AS DESCRIBED IN SPOEK ET AL. SHOULD BE CARRIED OUT. [*] THE
PROPOSED TESTS SHOULD BE PERFORMED BY THE NOTIFIER AND THE RESULTING
DATA PROVIDED IN ORDER TO GUARANTEE A HIGH LEVEL OF SAFETY AND PUBLIC
CONFIDENCE IN THE APPROACH TAKEN."
WITH REGARD TO WHOLE FOOD STUDIES:
"WHOLE FOOD STUDIES ARE NECESSARY TO COMPLETE THE ASSESSMENT OF THE
SAFETY OF NEW FEEDS OR FOODS FOR THE FOLLOWING REASONS: THE
DETERMINATION OF THE NUTRIENTSTOXICANTS (SUBSTANTIAL EQUIVALENCE) CAN
NOT DETECT ALL UNINTENDED EFFECTS (PRODUCTS); THE LEVEL OF PROTEINS MAY
BE INCREASING SIGNIFICANTLY IN SUCCESSIVE PRODUCTS [*]"
AND WITH REGARD TO THE USED TEST SUBSTANCE:
"[T]OXICOLOGY OF THE NEWLY EXPRESSED PROTEINS IN THE GM PRODUCTS AT
STAKE, WAS OFTEN TESTED WITH "SURROGATE" PROTEINS (I.E. ISOLATED FROM
HETEROLOGOUS SYSTEMS, DIFFERENT FROM THE GM PLANT, SEE REVIEW BY FREESE
AND SCHUBERT (2004)), WITHOUT PROPER DEMONSTRATION OF BIOCHEMICAL,
STRUCTURAL, OR FUNCTIONAL EQUIVALENCE OF THE SURROGATE PROTEIN TO ITS
COUNTERPART (FOR INSTANCE AS REGARDS MUTATIONAL CHANGES, POST
TRANSLATIONAL MODIFICATIONS, OR OTHERS), AS RECOMMENDED IN PARAGRAPH 40
OF THE CODEX GUIDELINES." REMARKABLE HERE IS THE REFERENCE TO THE CODEX
ALIMENTARIUS GUIDELINES, AS THE CODEX ALIMENTARIUS COMMISSION IS ONE OF
THE STANDARD SETTING BODIES RECOGNIZED IN THE SPS AGREEMENT.
ALTHOUGH THIS DOES NOT MEAN, THAT THE EUROPEAN COMMISSION IS SUBSCRIBING
TO ALL THE ARGUMENTS BROUGHT UP BY AUSTRIA, IT SUPPORTS IN MANY WAYS THE
AUSTRIAN ARGUMENTS TO JUSTIFY ITS SAFEGUARD MEASURES, EVEN IF THE
EUROPEAN COMMISSION BY DOING SO CONTRADICTS THE SCP AND THE EFSA PANEL
ON GMOS.
MOST IMPORTANT IN THIS CONTEXT IS THAT THE EUROPEAN COMMISSION
RECOGNISES THAT THE AVAILABLE INFORMATION IS INCOMPLETE.
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THE OPINION OF AN ADVISOR TO THE WTO PANEL IN THE WTO REPORT A SMALL
GROUP OF SCIENTIFIC EXPERTS WERE PROVIDING SCIENTIFIC INPUT TO QUESTIONS
POSED BY THE PANEL ON VARIOUS ISSUES. THE EXPERTS' ADVICE WAS PROVIDED
TO ASSIST THE PANEL IN THE SCIENTIFIC ASSESSMENTS, AND SHOULD NOT COVER
GENERAL OPINIONS ON THE SAFETY OF GMOS. EXPERT OPINIONS SHOULD BE
LIMITED TO SCIENTIFIC AND TECHNICAL ISSUES, WHEREAS THE TASK OF ANY
LEGAL ASSESSMENT REMAINED WITH THE PANEL.
DR. DAVE ANDOW, ONE OF THE SCIENTISTS FROM THIS GROUP OF EXPERTS,
SPECIFICALLY PROVIDED VALUABLE SCIENTIFIC EVIDENCE TO BE TAKEN INTO
ACCOUNT (WTO 2006, ANNEX H AND J). DR. ANDOW CONSIDERED IN DEPTH THE
INDIVIDUAL JUSTIFICATIONS PROVIDED BY AUSTRIA IN ITS PROHIBITION OF GM
MAIZE MON810. IN PARTICULAR HE PROVIDED INFORMATION, WHETHER THERE WAS
SUFFICIENT SCIENTIFIC EVIDENCE AVAILABLE TO AUSTRIA IN JUNE 1999 AND IN
AUGUST 2003 TO UNDERTAKE A MORE OBJECTIVE ASSESSMENT OF POTENTIAL RISKS
TO THE ENVIRONMENT FROM GM MAIZE MON810.
1. DR. ANDOW STATED THAT IN 2003 AUSTRIA COULD REASONABLY MAINTAIN THAT
THERE IS STILL INSUFFICIENT INFORMATION TO KNOW WHICH NON-TARGET
ORGANISMS MIGHT BE AT RISK AND THEREFORE AN OBJECTIVE RISK ASSESSMENT
WAS NOT POSSIBLE. HE EMPHASISED THAT NOT ALL OF THE NON-TARGET SPECIES
AT RISK CAUSED BY GM MAIZE MON810 HAD BEEN IDENTIFIED IN EUROPE. DR.
ANDOW COMMENTED ON THE FOLLOWING POINTS WHICH WERE NOT REFLECTED IN THE
SCP OPINION: FIRST ADDITIONAL ASSESSMENTS SHOULD HAVE BEEN CONDUCTED ON
LACEWINGS AND MONARCH BUTTERFLIES IN ORDER TO DETERMINE THE RELEVANCE IN
THE FIELD. THE AIM OF A TIERED RISK ASSESSMENT PROTOCOL IS TO EXPOSE
ORGANISMS TO CONCENTRATIONS HIGHER THAN CONSIDERED TYPICAL IN THE FIELD.
THEREFORE EXPERIMENTAL POSITIVES FROM LABORATORY STUDIES SHOULD UNDERGO
ADDITIONAL EVALUATIONS. BOTH LACEWINGS AND MONARCHS HAD BEEN ADVERSELY
AFFECTED BY THE CRY1AB TOXIN IN LABORATORY EXPERIMENTS. SECONDLY THE
SPECIFICITY OF THE CRY1AB TOXIN SEEMED TO BE BROADER THAN PREVIOUSLY
EXPECTED. 2. WITH RESPECT TO RISKS ON SOIL ORGANISMS DR. ANDOW DISCUSSED
SOME SCIENTIFIC
ASPECTS THAT WERE LEFT UNCONSIDERED BY THE SCP. FIRST THE ACTUAL RATES
AND DEGRADATION PROCESSES FOR LARGE PROTEINS IN SOILS ARE POORLY
UNDERSTOOD. SECOND, THE BT TOXIN LOAD IN MAIZE FIELDS CAN BE SUBSTANTIAL
WHICH MAKE LARGE-SCALE EFFECTS POSSIBLE. THIRD, IT IS KNOWN THAT THE BT
TOXIN IN THE SOIL CAN HAVE ADVERSE EFFECTS ON EARTHWORMS. 3. REFERRING
TO RESISTANCE RISK AND MANAGEMENT DR. ANDOW STATED THAT THE
FOLLOWING POINTS WERE NOT REFLECTED IN THE SCP OPINION. FIRST THE RATE
OF MARKET PENETRATION OF BT MAIZE HAD BEEN FASTER THAN PREDICTED IN THE
US WHICH CONTRADICTED THE PREDICTION OF THE SCP THAT MARKET PENETRATION
WOULD BE SLOW. SECONDLY RESISTANCE WOULD EVOLVE LOCALLY AND THEREFORE
REFUGES MUST BE AVAILABLE WHEREVER BT MAIZE IS LOCALLY USED AND REFUGES
ARE REQUIRED FROM THE BEGINNING OF BT PLANTING. RESISTANCE MANAGEMENT IS
THE RESPONSIBILITY OF EACH FARMER WHO USES BT MAIZE AND EACH FARMER
SHOULD BE REQUIRED TO IMPLEMENT MEASURES SUCH AS SETTING UP OF REFUGES.
IN SUMMARY DR. ANDOW, IN HIS CAPACITY AS SCIENTIFIC ADVISOR TO THE WTO
PANEL, SUPPORTED THE AUSTRIAN POINT OF VIEW, THAT THERE IS INSUFFICIENT
INFORMATION ESPECIALLY ON POSSIBLE NEGATIVE EFFECTS ON NON-TARGET
ORGANISMS, SOIL ORGANISMS AND THE QUESTION OF RESISTANCE RISK AND
MANAGEMENT.
CONCLUSIONS AUSTRIA STATED DURING THE AUTHORISATION PROCEDURE THAT THERE
WAS A LACK OF INFORMATION IN ORDER TO CARRY OUT AN ADEQUATE RISK
ASSESSMENT. SUBSEQUENTLY THE CONCERNS WERE RECONFIRMED WHEN JUSTIFYING
ITS SAFEGUARD MEASURES. BASED ON THESE ARGUMENTS THE IMPORT BANS WHERE
ISSUED. IN THE FOLLOWING PROCEDURE AUSTRIA EXTENDED ITS SCIENTIFIC
REASONING ALSO TO POSSIBLE NEGATIVE EFFECTS ON HUMAN HEALTH.
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THOUGH THE SCP COULD NOT IDENTIFY ANY RISK LINKED TO THE PLACING ON THE
MARKET OF GM MAIZE MON810 IT ALSO STATED (SECOND OPINION) THAT FURTHER
WORK IS NEEDED TO IDENTIFY ANY POSSIBLE EFFECTS ON NON TARGET ORGANISMS.
EFSA NEVER EXAMINED THE ORIGINAL APPLICATION. IT IS HIGHLY DOUBTFUL,
THAT THE INFORMATION INCLUDED IN THE ORIGINAL APPLICATION WOULD BE
SUFFICIENT TO FULFIL THE CRITERIA OF THE NEW AUTHORISATION PROCEDURE
ACCORDING TO REGULATION (EC) 1829/03 AND THE REQUIREMENTS OF THE EFSA
GUIDANCE DOCUMENT ON RISK ASSESSMENT (EFSA 2006).
MOST ARGUMENTS OF AUSTRIA WERE ACKNOWLEDGED BY THE EUROPEAN COMMISSION,
SUPPORTING THE VIEW THAT THE SCIENTIFIC INFORMATION IS INCOMPLETE. SOME
OF THE STATEMENTS BY THE EUROPEAN COMMISSION ARE IN CLEAR CONTRADICTION
TO SCP AND EFSA OPINIONS.
SOME OF THE ARGUMENTS ARE EVEN SUPPORTED, AND BACKED BY ADDITIONAL
SCIENTIFIC ARGUMENTS BY AT LEAST ONE OF THE SCIENTIFIC ADVISORS TO THE
WTO PANEL.
REVIEWING ALL THE STATEMENTS/OPINIONS DELIVERED BY THE DIFFERENT
SCIENTISTS AND THE EUROPEAN COMMISSION, IT IS CLEARLY SHOWN, THAT ALL OF
THEM, EXCEPT THE EFSA PANEL, WHICH DID NOT EXAMINE THE ORIGINAL
APPLICATION, CONFIRM THE AUSTRIAN VIEW THAT THE AVAILABLE INFORMATION IS
"INSUFFICIENT" OR "INCOMPLETE" OR THAT FURTHER WORK IS NEEDED, AND A
PROPER RISK ASSESSMENT COULD NOT HAVE BEEN CARRIED OUT.
THIS BACKS THE AUSTRIAN POSITION THAT THE RISK ASSESSMENT CARRIED OUT
BASED ON THE INFORMATION PROVIDED IN THE ORIGINAL APPLICATION DOES NOT
FULFIL THE CRITERIA OF THE CURRENT EUROPEAN LEGISLATION AND THE SPS
AGREEMENT.
REMARKS WITH REGARD TO MAIZE T25 THIS REPORT FOCUSES ON THE GENETICALLY
MODIFIED (GM) MAIZE MON810 BECAUSE OF ITS HIGHER RELEVANCE CONCERNING
CULTIVATION IN AUSTRIA COMPARED TO GM MAIZE T25. MON810 VARIETIES HAVE
BEEN AUTHORIZED FOR PLANTING IN THE EU AND GM MAIZE MON810 IS ALREADY
USED BY FARMERS IN SEVERAL EUROPEAN COUNTRIES.
ALTHOUGH MANY ISSUES WHICH WERE DISCUSSED ABOVE FOR GM MAIZE MON810 ARE
ALSO VALID FOR GM MAIZE T25, LIKE THE IMPROPER ASSESSMENT OF
TOXICOLOGICAL AND ALLERGENIC EFFECTS, THE MAIN ENVIRONMENTAL CONCERNS OF
AUSTRIA ARE SUMMARIZED IN THE FOLLOWING PARAGRAPHS. MORE DETAILS ARE
GIVEN IN DOLEZEL ET AL. (2007)
SPECIFIC ENVIRONMENTAL RISKS OF GM MAIZE T25WHICH WERE IDENTIFIED ARE
RISKS FOR WEED COMMUNITIES LACK OF A MONITORING PLAN REGIONAL
ASPECTS IN COMBINATION WITH COEXISTENCE ISSUES
IN SUMMARY THE RISK ASSESSMENT DATA AVAILABLE FOR GENETICALLY MODIFIED
HERBICIDE TOLERANT (GMHT) MAIZE T25 DO NOT FULFIL THE REQUIREMENTS FOR
AN ASSESSMENT OF HOW THESE NEW HERBICIDE/GM PLANT REGIMES COULD AFFECT
WEED COMMUNITIES. AS CHANGES IN WEED MANAGEMENT ARE TO BE EXPECTED WITH
INTRODUCTION OF GM MAIZE T25, A PROPER ASSESSMENT OF THE EFFECTS ON WEED
COMMUNITIES IS REQUIRED, BASED ON AN IN-DEPTH ANALYSIS OF WEEDS AND
INTERACTIONS BETWEEN THE GMO AND TARGET ORGANISMS OF GM MAIZE T25 AS
REQUIRED BOTH UNDER DIRECTIVE 90/220/EEC (ANNEX II, IV. C.3 AND C.4) AND
DIRECTIVE 2001/18/EC (ANNEX IIIB, D.). THE INSUFFICIENT CONTROL OF
CERTAIN WEEDS PROVIDED BY GLUFOSINATEAMMONIUM AND THE RESULTING SHIFT IN
WEED COMMUNITIES HAS TO BE CONSIDERED ADEQUATELY.
THE LACK OF A POST-MARKET MONITORING PLAN CONFLICTS WITH THE CURRENT
OBLIGATIONS FOR PRODUCTS SUCH AS GM MAIZE T25. ANNEX VII OF DIRECTIVE
2001/18/EC IS AN AGREED MINIMUM STANDARD FOR THIS ISSUE. FURTHERMORE,
LONG TERM EFFECTS OF THE HERBICIDE TOLERANT PLANT CANNOT BE EVALUATED
INDEPENDENTLY FROM THE RESPECTIVE HERBICIDE USE AND EFFECTS OF
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GLUFOSINATE-AMMONIUM IN COMBINATION WITH GM MAIZE T25 ON WEED
COMMUNITIES NEED TO BE ADDRESSED BY SUCH A MONITORING PLAN. ADDITIONALLY
THERE ARE OPEN QUESTIONS CONCERNING REGIONAL ASPECTS IN CONNECTION WITH
COEXISTENCE ISSUES. EU-WIDE PROVISIONS REGARDING COEXISTENCE MEASURES
(INCLUDING LIABILITY) OF GENETICALLY MODIFIED MAIZE AND CONVENTIONAL OR
ORGANIC MAIZE ARE STILL MISSING. THEREFORE ECONOMIC CONSEQUENCES FOR
ORGANIC OR CONVENTIONAL FARMERS CAN NOT BE EXCLUDED (SEE ALSO BELOW).
COMPETING RISK ASSESSMENT THIS CHAPTER EXAMINES AND ASSESSES THE
POTENTIAL RISKS OF THE GM MAIZE MON810. THE ASSESSMENT IS BASED ON THE
CURRENT SCIENTIFIC EVIDENCE CONCERNING THESE RISKS AND IS AIMED TO
FULFIL THE RECOMMENDATION BY THE WTO PANEL TO BRING THE RISK ASSESSMENT
IN LINE WITH THE REQUIREMENTS OF THE SPS AGREEMENT.
THE STRUCTURE FOLLOWS THE MOST RECENT GUIDANCE FOR SUCH ASSESSMENTS AS
GIVEN BY THE EFSA "GUIDANCE DOCUMENT OF THE SCIENTIFIC PANEL ON
GENETICALLY MODIFIED ORGANISMS FOR THE RISK ASSESSMENT OF GENETICALLY
MODIFIED PLANTS AND DERIVED FOOD AND FEED" (EFSA 2006). FURTHERMORE
REFERENCE IS MADE TO THE RESPECTIVE ISSUES FOR RISK ASSESSMENT AS
SPECIFIED BY DIR. 2001/18/EC ANNEX II.
1. INFORMATION ON ANY TOXIC, ALLERGENIC OR OTHER HARMFUL EFFECTS ON
HUMAN OR ANIMAL HEALTH ARISING FROM THE GM FOOD/FEED
THIS CHAPTER COVERS ISSUES WHICH ARE LISTED IN THE EFSA GUIDANCE
DOCUMENT, ANNEX III, CHAPTER D.7. THESE ISSUES FOR RISK ASSESSMENT
CORRESPOND TO THE GUIDANCE ON RISK ASSESSMENT FOR GENETICALLY MODIFIED
HIGHER PLANTS AS DETAILED IN DIR. 2001/18/EC, ANNEX II, D.2.6 (POSSIBLE
IMMEDIATE AND/OR DELAYED EFFECTS ON HUMAN HEALTH). INDIVIDUAL REFERENCE
FOR THE ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN BELOW AND
INDICATED IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED BY EFSA
(EFSA 2006).
1.1 COMPARATIVE ASSESSMENT (D.7.1)
THE RESULTS FOR SUBSTANTIAL EQUIVALENCE FOR MON810 ARE BASED ON A
COMPOSITIONAL ANALYSIS THAT HAS SEVERAL SHORTCOMINGS: THE RANGE OF
PARAMETERS MEASURED IS VERY NARROW. ONLY PROXIMATES, AMINO ACIDS AND
FATTY ACIDS ARE INCLUDED IN THE COMPARATIVE ANALYSIS. MICRONUTRIENTS AND
OTHER IMPORTANT INGREDIENTS ARE NOT CONSIDERED. FURTHERMORE, EVEN THESE
DATA DO NOT ALWAYS INCLUDE FIBRES, ADF AND NDF (IN THE CASE OF 1994
FIELD TRIALS). THIS INVESTIGATED SET OF ASSESSED COMPONENTS MUST BE
CONSIDERED AS TOO NARROW WHEN COMPARED TO THE OECD (2002) AND TO THE
EUROPABIO (2001) CONSENSUS DOCUMENTS.
DIFFERENCES ARE DETECTED BETWEEN MON810 AND THE CONTROL, E.G. FOR
GLUTAMINE, LEUCIN, PROLINE, ADF, NDF, C18:1 AND C18:2 FATTY ACIDS,
STARCH, PROTEIN. THESE DIFFERENCES ARE NOT CONSIDERED RELEVANT, AS STILL
WITHIN LITERATURE RANGES. IN ONE CASE THE LITERATURE RANGE USED WAS
EXCEEDED (PROTEIN, US TRIALS). THE APPLICANT USED AN OLDER LITERATURE
RANGE (1976) IN ORDER TO "NORMALISE" THE DEVIATION. NONE OF THE
DIFFERENCES WERE CONSIDERED A REASON TO REPEAT OR EXTEND THE COMPARATIVE
ANALYSIS.
LAST NOT LEAST IT APPEARS THAT NO ISOGENIC CONTROL LINE WAS USED.
IF COMPOSITIONAL ANALYSIS IS USED AS AN INDICATOR FOR UNINTENDED
EFFECTS, THE NUMBER OF SUBSTANCES, FOR WHICH DATA ARE PRESENTED, IS TOO
SMALL. IF USED FOR NUTRITIONAL ASSESSMENT, CERTAIN PROXIMATES AND
MICRONUTRIENTS ARE MISSING.
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1.2 TOXICOLOGY (D.7.8)
TOXICITY ASSESSMENT IN THE ORIGINAL DOSSIER BASICALLY RELIES ON AN ACUTE
TOXICITY TEST AND ON IN-VITRO DIGESTIBILITY STUDIES USING A BACTERIAL
CRYIA(B) PROTEIN. IN ADDITION, THE APPLICANT PROVIDED HOMOLOGY
COMPARISONS WITH KNOWN TOXIC PROTEINS AND ARGUED WITH THE SAFE HISTORY
OF BT TOXINS. RESULTS OBTAINED FROM ACUTE TOXICITY TESTS OF THE CRYIA(B)
PROTEIN ON RODENTS CANNOT BE EXTRAPOLATED FOR SUB-CHRONIC AND CHRONIC
EFFECTS. THE ASSUMPTION THAT PROTEINS CAN ONLY ACT VIA ACUTE MECHANISMS
IS NOT BACKED UP BY A SOLID EMPIRICAL BASIS. THIS HAS MEANWHILE BEEN
ACKNOWLEDGED BY RECENT GUIDANCE DOCUMENTS, WHICH ASK FOR 28-DAY
REPEATED-DOSE SUB-ACUTE TEST (EFSA 2006 AND NL BIOSAFETY COUNCIL 2003).
FOR CONDUCTING STUDIES ON TOXIC AS WELL AS ALLERGENIC PROPERTIES OF
NOVEL PROTEINS TEST PROTEINS WERE PRODUCED FROM BACTERIA. USING TEST
PROTEINS FROM MICROBES WOULD IN PRINCIPLE BE ACCEPTABLE IF THE PROTEINS
PRODUCED IN THE GM CROP AND THE MICROBE WOULD BE IDENTICAL OR AT LEAST
EQUIVALENT WITH RESPECT TO PROPERTIES INVESTIGATED IN THE TEST. HOWEVER,
SEVERAL DIFFERENCES THAT MIGHT OCCUR TO THE PROTEIN IN CASES THE SAME
GENE IS EXPRESSED IN PLANTS AND MICROBES HAVE BEEN POINTED OUT
(GURIAN-SHERMAN 2003B, FREESE AND SCHUBERT 2004). DIFFERENCES MIGHT
OCCUR AT THE LEVEL OF DNA SEQUENCE DURING TRANSFORMATION AND IN RNA
SPLICING, EVENTUALLY RESULTING IN AN ALTERED AMINO ACID SEQUENCE.
POSTTRANSLATIONAL PROCESSING INCLUDING PROTEOLYTIC PROCESSING,
GLYCOSYLATION, ACETYLATION, PHOSPHORYLATION, METHYLATION AND FOLDING
MIGHT ALSO DIFFER BETWEEN PLANTS AND MICROBES.
BACTERIAL PROTEINS WERE ALSO USED FOR IN VITRO DIGESTIBILITY STUDIES.
WHOLE PLANT FEEDING STUDIES WERE NOT PERFORMED.
IT HAS TO BE CONCLUDED THAT THE ASSESSMENT OF TOXIC PROPERTIES OF MON810
AND THE PRODUCED BT-TOXIN IS BASED ON ONLY A FEW RESULTS, WHICH
SOMETIMES ARE OBTAINED BY METHODS WHICH HAVE BEEN QUESTIONED IN THE
SCIENTIFIC LITERATURE RECENTLY. THEREFORE WE BELIEVE THAT THE DATA
PROVIDED DO NOT SUPPORT THE SAFETY-ASSUMPTION FOR MON810 MAIZE
SUFFICIENTLY.
1.3. ALLERGENICITY (D.7.9)
ALLERGENICITY TESTING IN CASE OF THE MON810 DOSSIERS IS LIMITED TO THE
INTRODUCED CRYIA(B) PROTEIN AND CONSISTS OF IN-VITRO-DIGESTIBILITY TESTS
AND HOMOLOGY COMPARISONS TO KNOWN ALLERGENS. HISTORY OF SAFE USE OF BT
PROTEINS IN GENERAL AND LOW EXPRESSION LEVELS ARE ALSO MENTIONED TO
SUPPORT THE SAFETY CLAIM.
AS DISCUSSED IN DETAIL IN SPOEK ET AL. (2005) THESE METHODS DO NOT
PROVIDE ANY DIRECT EVIDENCE OF ALLERGIC PROPERTIES AND NOT AT ALL ON
SENSITIZING PROPERTIES. FURTHERMORE, THE METHODS AND EVIDENCE USED
CANNOT BE CONSIDERED AS RELIABLE INDICATORS OF ALLERGENIC PROPERTIES. A
DETAILED REVIEW OF THE SHORTCOMINGS OF THE ALLERGENICITY ASSESSMENT
PROVIDED BY THE APPLICANT WITH REGARD TO MON810 MAIZE IS GIVEN IN
DOLEZEL ET AL. (2007). THE FOLLOWING PUNCTUATION LISTS THE MAIN POINTS
OF CRITICISM:
SCIENTIFIC STUDIES INVESTIGATING ALLERGENIC PROPERTIES OF PROTEINS IN
CONNECTION WITH THEIR DIGESTIBILITY/STABILITY COULD NOT FIND A
CORRELATION AT ALL (KENNA & EVANS 2000, FU ET AL. 2002). THEREFORE, IF
ALLERGENIC PROPERTIES ARE ONLY CONCLUDED FROM THE STABILITY OF POSSIBLE
ALLERGENS, WHICH IS INVESTIGATED USING IN-VITRO DIGESTIBILITY STUDIES,
FALSE POSITIVE AND FALSE NEGATIVE RESULTS IN SAFETY TESTING MIGHT BE
POSSIBLE. FURTHERMORE, THE DIFFERENCES IN THE DESIGN OF IN-VITRO STUDIES
CAST CONSIDERABLE DOUBT WHETHER THESE EXPERIMENTS PROVIDE MEANINGFUL
DATA AT ALL.
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ROUTINELY USED SEQUENCE COMPARISON TECHNOLOGIES SUCH AS FASTA AND
BLAST (PEARSON 2000, ALTSCHUL ET AL. 1990A, B) AS WELL AS NEW METHODS
DEVELOPED MORE SPECIFICALLY FOR PREDICTING THE ALLERGENIC POTENTIAL OF A
GIVEN PROTEIN WOULD PROVIDE FALSE POSITIVE AND FALSE NEGATIVE RESULTS IN
MANY CASES AS RESULTS OF THE COMPARISONS MIGHT DIFFER DEPENDING ON THE
PARAMETERS SET (E.G. SUBSTITUTION MATRIX AND GAP PENALTIES) (BOERKLUND
ET. AL. 2005).
THE HOMOLOGY COMPARISON REFERRED TO IN THE MON810 DOSSIER DATES BACK
TO 1990 AND 1995 RESPECTIVELY. GIVEN THE PACE OF IMMUNOLOGICAL RESEARCH
A MORE RECENT COMPARATIVE ANALYSIS WOULD HAVE INCLUDED FIVE TIMES MORE
SEQUENCES FROM ALLERGENIC PROTEINS (MARI 2005).
FURTHERMORE, EXPRESSION LEVELS OF PROVEN ALLERGENS MAY GREATLY VARY IN
DIFFERENT STRAINS, TISSUES AND DEVELOPMENTAL STAGES, AND CAN BE
INFLUENCED BY A VARIETY OF FACTORS. THIS HAS ALSO BEEN ACKNOWLEDGED BY A
JOINT FAO/WHO EXPERT CONSULTATION WHICH CONCLUDED THAT IT IS NOT
POSSIBLE TO LINK POTENTIAL ALLERGENICITY OF A GIVEN PROTEIN TO ITS
EXPRESSION LEVEL (FAO/WHO 2001).
EQUALLY IMPORTANT, ALLERGENICITY ASSESSMENT OF THE INTRODUCED PROTEIN
SHOULD BE COMPLEMENTED BY AN ASSESSMENT OF THE WHOLE-PLANT AS DESCRIBED
IN SPOEK ET AL. 2005.
1.4. MAIZE T25 - HEALTH ASPECTS
THE FOLLOWING PARAGRAPHS SUMMARIZE THE AUSTRIAN FINDINGS WITH REGARD TO
THE APPLICATION FOR PLACING ON THE MARKET OF THE GM MAIZE T25. MORE
DETAILS AND REFERENCES TO THE SCIENTIFIC LITERATURE ARE GIVEN IN DOLEZEL
ET AL. (2007).
THE ASSESSMENT OF THE DATA PROVIDED BY THE APPLICANT WITH REGARD TO THE
AUTHORIZATION OF THE GENETICALLY MODIFIED MAIZE T25 REVEALS A NUMBER OF
SHORTCOMINGS AND A LACK OF VERIFIABILITY. TOXICITY ASSESSMENT DOES NOT
CONSIDER EFFECTS BEYOND A 14-DAY STUDY OF THE INTRODUCED PROTEIN. ALL
STUDIES ARE CARRIED OUT ON ISOLATED PROTEINS. POSSIBLE TOXIC PROPERTIES
OF THE WHOLE-PLANT ARE NOT CONSIDERED AT ALL. THE ASSESSMENT OF THE
ALLERGENIC POTENTIAL IS BASED ON METHODS AND EVIDENCE THAT CANNOT BE
CONSIDERED SUFFICIENTLY RELIABLE. THE APPROACH USED IS EVEN LESS
APPROPRIATE TO ASSESS ANY DE-NOVO SENSITIZING PROPERTIES. THE
POSSIBILITY OF ALLERGENIC PROPERTIES OF THE WHOLEPLANT IS NOT CONSIDERED
AT ALL. FIELD TRIALS AND COMPOSITIONAL ANALYSIS ARE NOT FULLY VERIFIABLE
AND IT IS NOT CLEAR WHETHER THEY HAVE BEEN PROPERLY CONDUCTED. IN LIGHT
OF THE MOST RECENT GUIDANCE PROVIDED, THE INFORMATION INCLUDED IN THE
DOSSIER WOULD ALSO NOT BE SUFFICIENT FOR A MARKET AUTHORISATION UNDER
DIRECTIVE 2001/18/EC OR REGULATION (EC) 1829/2003. IN SUMMARY, FROM THE
DATA PROVIDED IN THE DOSSIER OF MAIZE T25 AND IN THE LIGHT OF RECENT
EVIDENCE FROM SCIENTIFIC LITERATURE, IT IS NEITHER POSSIBLE TO FULLY
VERIFY ALL ASPECTS OF THE RISK ASSESSMENT CONDUCTED BY THE APPLICANT NOR
TO CONCLUDE A SUFFICIENT DEGREE OF SAFETY.
2. POTENTIAL CHANGES IN THE INTERACTIONS OF THE GM PLANT WITH THE BIOTIC
ENVIRONMENT RESULTING FROM THE GENETIC MODIFICATION
THIS CHAPTER COVERS ISSUES WHICH ARE LISTED IN THE EFSA GUIDANCE
DOCUMENT, ANNEX III, CHAPTER D.9. THESE ISSUES FOR RISK ASSESSMENT
CORRESPOND TO THE GUIDANCE ON RISK ASSESSMENT FOR GENETICALLY MODIFIED
HIGHER PLANTS AS DETAILED IN DIR. 2001/18/EC, ANNEX II, D.2. INDIVIDUAL
REFERENCE FOR THE ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN
BELOW AND INDICATED IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED
BY EFSA (EFSA 2006).
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2.1 POTENTIAL FOR GENE TRANSFER (D.9.3)
THE ASSESSMENT OF THE POTENTIAL FOR GENE TRANSFER IS PRESENTED ACCORDING
TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.3 CORRESPONDING
TO ISSUE D.2.3 AS LISTED IN DIR. 2001/18/EC, ANNEX II. SPECIAL
CONSIDERATION IS GIVEN TO THE DEMAND THAT THE ASSESSMENT SHOULD ALSO
CONSIDER THE CONSEQUENCES OF LOW FREQUENCIES OF GENE TRANSFER TO RELATED
AND UNRELATED ORGANISMS (EFSA 2006). THE ASSESSMENT AS PRESENTED IN THE
FOLLOWING IS RELEVANT FOR BOTH GM MAIZE MON810 AND GM MAIZE T25.
WITH RESPECT TO GENE TRANSFER THE NOTIFIER CONCLUDED THAT THE RISK OF
GENE TRANSFER WILL BE LIMITED BY POOR DISPERSAL AND THE ABSENCE OF
WILD-LIVING SEXUALLY-COMPATIBLE PLANTS EITHER OF THE SAME OR DIFFERENT
SPECIES. HOWEVER THE REGIONAL CONDITIONS FOR MAIZE CULTIVATION IN
AUSTRIA AND THE IMPLICATION OF THESE CONDITIONS FOR OUT-CROSSING AND
GENE TRANSFER WERE NOT CONSIDERED.
POLLEN PRODUCTION AND VIABILITY WERE CONSIDERED TO BE UNCHANGED FOR GM
MAIZE MON810 (OR GM MAIZE T25) AND THEREFORE DISPERSAL AND OUT-CROSSING
SHOULD NOT BE DIFFERENT FROM OTHER MAIZE VARIETIES. THEREFORE GENE
TRANSFER FROM GM MAIZE MON810 (OR GM MAIZE T25) TO OTHER MAIZE COULD
OCCUR THROUGH POLLEN DISPERSAL DURING THE CULTIVATION OF THE CROP. MAIZE
IS PREDOMINANTLY WIND POLLINATED. MAIZE PLANTS PRODUCE POLLEN FOR 10-13
DAYS AND THE SHED POLLEN REMAINS VIABLE FOR A SHORT TIME. THOUGH IT IS
KNOWN THAT VIABLE POLLEN IS TRANSPORTED OVER VARIABLE DISTANCES RELATING
TO THE LOCAL METEOROLOGICAL CONDITIONS, THE NOTIFIER CONCLUDES THAT THE
POLLEN FROM GM MAIZE MON810 IS ONLY DISTRIBUTED OVER SHORT DISTANCES. AN
APPROXIMATION WHICH IS TYPICALLY REFERRED TO IS THAT 98% OF POLLEN
SETTLES WITHIN 25-50 M OF ITS SOURCE (EEA, 2002). HOWEVER IN EXPERIMENTS
CONDUCTED TO ESTIMATE THE AMOUNT OF POLLEN WHICH IS CARRIED FROM A PLOT
INTO NEIGHBOURING ENVIRONMENTS USING POLLEN-MASS-FILTERS DISTANCES OF UP
TO 2 700 M WERE SEEN (BEISMANN & KUHLMANN 2006; HOFMANN ET AL. 2005),
WITH SUBSTANTIAL QUANTITIES OF POLLEN FOUND AT 2 400 M DOWNWIND OF THE
POLLEN SOURCE (HOFMANN ET AL. 2005).
DATA ON POLLEN TRANSPORT HOWEVER ARE NOT FULLY CONCLUSIVE FOR ASSESSING
THE POTENTIAL FOR GENE TRANSFER THROUGH OUT-CROSSING. EMPIRICAL DATA
FROM DIFFERENT SOURCES ON OUT-CROSSING FREQUENCIES SHOW SOME VARIATION.
AN EVALUATION UNDER AUSTRIAN CONDITIONS AND BASED ON DATA FROM SEED
CERTIFICATION STUDIES INDICATED AT A DISTANCE OF APPROXIMATELY 200 M THE
OUT-CROSSING RATE IS LESS THAN 0.9 %. AT APPROXIMATELY 300 M DISTANCE
THE OUT-CROSSING RATE IS AROUND 0.1 % (PASCHER & DOLEZEL 2005). THE
EFFECT OF GENE TRANSFER CAN THUS BE RELEVANT IN A SCENARIO OF A LIMITED
AMOUNT OF GMO-PLOTS COMPARED TO NON-GMO PLOTS (10 % GM MAIZE AREA).
HIGHER RATES OF ADOPTION OF GM MAIZE CROPS LEAD TO EVEN MORE PRONOUNCED
EFFECTS. DATA FROM THE BRITISH FARM SCALE EVALUATIONS (HENRY ET AL.
2003) SHOW SIMILAR PATTERNS AND AN ISOLATION DISTANCE OF APPROXIMATELY
260 M WAS DEDUCED TO LIMIT OUT-CROSSING RATES TO APPROXIMATELY 0.1 %.
EXPERIMENTS TO TEST FOR OUT-CROSSING EFFECTS OF MAIZE IN AUSTRIA DID
EVEN ADVISE LARGER DISTANCES TO MINIMISE THE RISK FOR OUTCROSSING (AGES
2006). AN ADDITIONAL IMPORTANT CONCLUSION IS THAT OTHER FACTORS THAN
DISTANCE BETWEEN PLOTS, LIKE WINDFALL AND POLLEN CONCENTRATION AMONG
OTHERS, INFLUENCE OUT-CROSSING EFFECTS (AGES 2006). DATA FROM THE
EVALUATION OF CULTIVATION OF GM MAIZE MON810 SHOWED RESULTS THAT ARE
RELEVANT WITH REGARD TO COMPARABLE AUSTRIAN CONDITIONS. SPECIFIC DATA DO
INDICATE SUBSTANTIAL OUT-CROSSING FREQUENCIES UP TO 10% IN THE VICINITY
OF PLOTS ON WHICH GM MAIZE MON810 WAS GROWN (EDER 2006). BASED UPON
THESE RESULTS IT WAS CONCLUDED THAT A MINIMUM OF 100 M OR 150 M IS
ADVISED RESPECTIVELY IN ORDER NOT TO SURPASS THE 0.9 % THRESHOLD LEVEL
(EDER 2006; MILLER 2006).
IN CONCLUSION THE DATA INDICATE THAT GENE FLOW FROM GM MAIZE MON810 (OR
GM MAIZE T25 RESPECTIVELY) THROUGH OUT-CROSSING TO NEIGHBOURING
NON-MODIFIED VARIETIES IS LIKELY AND HAS RELEVANT ENVIRONMENTAL AND
AGRICULTURAL CONSEQUENCES IN AUSTRIA. THIS FACT IS ALSO IMPORTANT WHEN
ASSESSING ECONOMIC CONSEQUENCES OF GENE TRANSFER (SEE CHAPTER 3).
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2.2 INTERACTIONS BETWEEN THE GM PLANT AND TARGET ORGANISMS (D.9.4)
ACCORDING TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.4
CORRESPONDING TO ISSUE D.2.4 AS LISTED IN DIR. 2001/18/EC, ANNEX II AN
ASSESSMENT OF THE ENVIRONMENTAL IMPACT RESULTING FROM DIRECT AND
INDIRECT INTERACTIONS BETWEEN THE GMO AND TARGET ORGANISMS, SPECIFICALLY
THE HERBIVOROUS LEPIDOPTERAN PEST SPECIES, LIKE THE EUROPEAN CORN BORER,
WHICH ARE TARGETED BY THE HETEROLOGOUS BT-TOXIN PRODUCED BY THE GM MAIZE
MON810, IS REQUIRED. DEVELOPMENT OF RESISTANCE IN THE PEST SPECIES
AGAINST THE BT-TOXIN NEEDS TO BE CONSIDERED WITHIN THIS ASSESSMENT. THIS
IS EXEMPLIFIED BY THE EU WORKING GROUP ON BT, WHICH HAS DEVELOPED RISK
ASSESSMENTS PROTOCOLS FOR EVALUATING THE DEVELOPMENT OF RESISTANCE IN
TARGET INSECTS TO BT TOXINS (SCP, 1999).
WITH RESPECT TO RESISTANCE AND TOLERANCE ISSUES THE RESISTANCE
MANAGEMENT STRATEGY PROPOSED BY THE NOTIFIER MUST BE CONSIDERED AS
INADEQUATE. AS THE EFFECTIVENESS OF THE REFUGE STRATEGY CANNOT BE
DEDUCED FROM THE INFORMATION SUBMITTED BY THE NOTIFIER, THE SCP
EMPHASIZED THAT IT ADVISED ON THE ESTABLISHMENT OF NON-BT REFUGES AS AN
APPROPRIATE MEASURE. HOWEVER IT WAS POINTED OUT THAT DUE TO THE EXPECTED
SLOW INTRODUCTION IN EUROPE, BT CROPS WOULD BE SURROUNDED BY "NATURAL
REFUGES" FOR SOME TIME.
THIS ASSUMPTION HOWEVER CANNOT BE JUSTIFIED FOR THE FOLLOWING REASONS:
FIRST THE RATE OF MARKET PENETRATION OF BT MAIZE AS SEEN IN THE US WAS
FASTER THAN PREDICTED. FOR ASSESSMENT OF POSSIBLE RESISTANCE DEVELOPMENT
UNDER EUROPEAN CONDITIONS IT WAS ASSUMED THAT MARKET PENETRATION WOULD
BE SLOW. SECONDLY RESISTANCE WOULD EVOLVE LOCALLY AND THEREFORE REFUGES
MUST BE AVAILABLE, WHEREVER BT MAIZE IS LOCALLY USED AND REFUGES ARE
REQUIRED FROM THE BEGINNING OF BT PLANTING ONWARDS. RESISTANCE
MANAGEMENT IS THE RESPONSIBILITY OF EACH FARMER WHO USES BT MAIZE AND
EACH FARMER SHOULD BE REQUIRED TO IMPLEMENT MEASURES SUCH AS SETTING UP
OF REFUGES (SEE E.G. ANDOW IN WTO, 2006 FOR REFERENCE).
THE INSECT RESISTANCE MANAGEMENT (IRM) PLAN ITSELF, WHICH WAS PROVIDED
BY THE NOTIFIER IS VERY GENERAL AND DOES NOT GIVE DETAILED INFORMATION
ON HOW IT WILL BE IMPLEMENTED. ALTHOUGH THE NOTIFIER RECOMMENDS A
MANAGED REFUGE APPROACH AND STATES THAT A SURVEILLANCE PROGRAM WILL BE
IMPLEMENTED, NO EXACT INFORMATION ON THE IMPLEMENTATION DETAILS OF THIS
PROGRAM IS GIVEN.
SPECIFICALLY WITH RESPECT TO SUSCEPTIBILITY STUDIES THE NOTIFIER REFERS
ONLY TO STUDIES IN THE US AND ITALY. WITHOUT ADEQUATE INFORMATION ON
BASELINE SUSCEPTIBILITIES OF PEST SPECIES AND INFORMATION ON INITIAL
RESISTANCE ALLELE FREQUENCIES IN THESE SPECIES THE RATE AT WHICH
RESISTANCE WILL EVOLVE CAN NOT BE DETERMINED. ADDITIONALLY IT IS NOT
POSSIBLE TO DEDUCE HOW THIS RATE DIFFERS AMONG DIFFERENT POPULATIONS OF
THIS INSECT SPECIES (HUANG ET AL. 1997). THESE ISSUES SHOULD BE
INVESTIGATED FOR EACH SEPARATE EUROPEAN CORN BORER POPULATION OR EVEN
SUB-POPULATION (CHAUFAUX ET AL. 2001).
THE SCIENTIFIC FACTS THUS DO NOT CONVINCINGLY SUPPORT THE HYPOTHESES ON
WHICH THE PROPOSED PLAN IS BASED. WITHOUT DEMONSTRATION BY THE NOTIFIER
OF THE SPATIAL DISTRIBUTION AND TOTAL AREAS OF GM MAIZE MON810 PLOTS IN
RELATION TO OTHER AREAS OF MAIZE CULTIVATION THE CONCLUSIONS DRAWN BY
THE NOTIFIER CANNOT BE VALIDATED. FURTHERMORE THE STRATEGY DOES NOT TAKE
INTO ACCOUNT THE DIFFERENT DISPERSAL CAPACITIES OF OTHER PEST SPECIES,
INCLUDING SESAMIA SPECIES (MEDITERRANEAN CORN STALK BORER). RESISTANCE
MANAGEMENT STRATEGIES DESIGNED FOR THE EUROPEAN CORN BORER ARE LESS
EFFICIENT FOR THE LESS POLYPHAGOUS AND MORE SEDENTARY SESAMIA
(EIZAGUIRRE ET AL. 2006). FURTHERMORE SESAMIA FOR REASONS OF REDUCED
SUSCEPTIBILITY IS LESS RESPONSIVE TO THE PROPOSED MANAGEMENT STRATEGY.
ADDITIONALLY IRM PLANS HAVE TO BE CARRIED OUT IN COMBINATION WITH
SYSTEMATIC MONITORING IN ORDER TO DETECT RESISTANCE AT THE VERY TIME OF
DEVELOPMENT. AS BASELINE SUSCEPTIBILITIES
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AND OTHER ECOLOGICAL FACTORS BETWEEN DIFFERENT POPULATIONS OF THE
RESPECTIVE PESTS AS WELL AS AGRONOMIC PRACTICES MIGHT DIFFER LOCALLY,
THE RESULTS OF THE EXPERIENCES GAINED FROM BT MAIZE CULTIVATION IN SPAIN
ARE NOT APPLICABLE WITHOUT FURTHER CONSIDERATION TO OTHER EUROPEAN
AGRICULTURAL SYSTEMS. THEREFORE AN ADAPTATION OF THE IRM STRATEGY MUST
BE ENVISAGED. AGAIN IT HAS TO BE TAKEN INTO ACCOUNT THAT SEVERAL
VARIETIES OF GM MAIZE MON810 ARE ALREADY APPROVED WITHIN THE EUROPEAN
UNION FOR CULTIVATION. THEREFORE IT CAN BE EXPECTED THAT FURTHER
ADOPTION RATES OF GM MAIZE MON810 WILL BE RATHER HIGH IN EUROPE. INDEED
RECENT DATA ON ADOPTION TRENDS IN EUROPE, WHICH CONFIRM AN INCREASE IN
CULTIVATION AREA OF APPROXIMATELY 70% FOR THE LAST SEASON, SUPPORT THIS
NOTION. HIGH ADOPTION RATES OF BT MAIZE VARIETIES HAVE ALSO BEEN
EXPERIENCED IN THE US (CARPENTER & GIANESSI 2001), ALTHOUGH A SLOW RATE
FOR INTRODUCTION OF THIS TYPE OF GM MAIZE HAD BEEN PREVIOUSLY PREDICTED.
THEREFORE THE EFFECTIVENESS OF THE STRATEGY PROPOSED BY THE NOTIFIER IN
ORDER TO PREVENT THE DEVELOPMENT OF RESISTANCE IN TARGET SPECIES, LIKE
THE EUROPEAN CORN BORER, IS DOUBTFUL. A REFINED STRATEGY ON RESISTANCE
MANAGEMENT NEEDS TO BE PROPOSED BY THE NOTIFIER AND ADEQUATE BASELINE
INFORMATION ON THE PEST BIOLOGY AND ECOLOGY AND A WORKABLE IRM PLAN HAS
TO BE SUBMITTED.
2.3 INTERACTIONS OF THE GM PLANT WITH NON-TARGET ORGANISMS (D.9.5)
ACCORDING TO THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.9.5
CORRESPONDING TO ISSUE D.2.5 AS LISTED IN DIR. 2001/18/EC, ANNEX II AN
ASSESSMENT OF THE ENVIRONMENTAL IMPACT RESULTING FROM DIRECT AND
INDIRECT INTERACTIONS BETWEEN THE GMO AND NON-TARGET ORGANISMS IS
REQUIRED. ANY EFFECTS ON ORGANISMS WHICH INTERACT WITH THE TARGET
ORGANISMS NEED TO BE TAKEN INTO ACCOUNT AS WELL.
2.3.1 EFFECTS ON OTHER NON-TARGET LEPIDOPTERAN SPECIES
POSSIBLE RISKS FOR NON TARGET ORGANISMS WERE CONSIDERED BY THE NOTIFIER
AND IN ALL PRECEDING ASSESSMENTS (E.G. SCP, 1998). THE CONCLUSION BY THE
NOTIFIER WAS BASED ON THE INFORMATION AS SUBMITTED. THIS INFORMATION IS
INTERPRETED IN A WAY THAT NO RELEVANT RISK FOR NON-TARGET HERBIVORES
INCLUDING VERTEBRATES IS IDENTIFIED.
HOWEVER WITH REGARD TO CURRENT ASSESSMENTS OF THE INFORMATION AVAILABLE
TO JUDGE POSSIBLE UNINTENDED EFFECTS ON NON-TARGET INSECTS THIS
CONCLUSION CANNOT BE SUPPORTED. MARVIER ET AL. (2007) RECENTLY
IDENTIFIED A NUMBER OF WEAKNESSES IN MOST OF THE AVAILABLE FIELD STUDIES
ON POTENTIAL ADVERSE EFFECTS OF INSECT RESISTANT GM CROPS, DURING AN
EFFORT TO SET UP A COMPREHENSIVE REPOSITORY OF DATA FOR EMPIRICAL
ASSESSMENTS. IN OUR OPINION THESE WEAKNESSES ALSO SEVERELY LIMIT THE
CONCLUSIVENESS OF THE FIELD TEST DATA SUBMITTED ON GM MAIZE MON810 (SEE
CHAPTER 1.3.2 FOR FURTHER DISCUSSION).
IT IS EVIDENT THAT GM MAIZE MON810 HAS THE POTENTIAL TO BE TOXIC TO
CERTAIN SPECIES OF LEPIDOPTERA AND THAT THIS ISSUE MUST BE DEALT WITH ON
A SPECIES-BY-SPECIES BASIS. THE NOTIFIER ASSUMES WITHOUT REFERENCE TO
REGIONAL CONDITIONS THAT CULTIVATED FIELDS ARE NOT CONSIDERED AS
IMPORTANT REPRODUCTIVE AREAS FOR LEPIDOPTERAN SPECIES AND EXPOSURE OF
NONTARGET LEPIDOPTERAN SPECIES WOULD NOT BE SIGNIFICANT. AN ASSESSMENT
OF RISKS TO NON-TARGET BUTTERFLIES ESPECIALLY RELATING TO EUROPEAN AND
SPECIFICALLY THE AUSTRIAN AGRICULTURAL CONDITIONS HAS NOT BEEN CARRIED
OUT IN THE RISK ASSESSMENT, IN SPITE OF INFORMATION THAT MANY SPECIES OF
BUTTERFLIES ARE PRESENT IN AGRICULTURAL AREAS (FELKE & LANGENBRUCH
2005).
GIVEN THE SUBSTANTIAL TRANSPORT OF TRANSGENIC POLLEN CONTAINING BT TOXIN
FROM THE GROWING AREAS INTO THE FIELD MARGINS AND TO ADJACENT HABITATS,
THESE SPECIES ARE VERY LIKELY TO BE EXPOSED TO POLLEN FROM GM MAIZE
MON810 UPON CULTIVATION. RECENT ANALYSES BASED ON DATA FROM STUDIES IN
GERMANY (E.G. HOFMANN ET AL. 2005) INDICATE THAT AN AVERAGE DEPOSITION
OF MORE THAN 5 POLLEN/CM 2 CAN BE EXPECTED AT A DISTANCE OF 300 M FROM
ADJACENT MAIZE FIELDS. IN THIS CONTEXT IT IS IMPORTANT TO NOTE THAT
INTAKE OF SMALL AMOUNTS
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OF POLLEN CONTAINING BT TOXIN CAUSE SUB-LETHAL EFFECTS ON NATIVE
LEPIDOPTERA LARVAE SUCH AS THE PEACOCK BUTTERFLY, INACHIS IO (FELKE &
LANGENBRUCH 2005). IN AUSTRIA THIS BUTTERFLY IS COMMONLY FOUND IN
HABITATS NEXT TO CULTIVATED AREAS OF MAIZE (TRAXLER ET AL. 2005).
OUR ASSESSMENT THAT OTHER BUTTERFLIES LIVING IN AGRICULTURAL HABITATS
WOULD BE SERIOUSLY AFFECTED IN CASE OF CULTIVATION IS SUPPORTED BY
RECENT RESEARCH (SZEKACS & DARVAS 2006). OTHER SCIENTIFIC STUDIES HAVE
RECENTLY INDICATED THAT CERTAIN NON-TARGET LEPIDOPTERA, LIKE MONARCH
BUTTERFLY LARVAE, SHOW PROLONGED DEVELOPMENTAL TIME AND REDUCED SURVIVAL
WHEN EXPOSED TO POLLEN OF BT MAIZE MON810 EITHER FOR SHORT OR FOR
PROLONGED TIME UNDER FIELD CONDITIONS, POSSIBLY RESULTING IN UP TO 25%
FEWER SURVIVING LARVAE (DIVELY ET AL. 2004). ALSO ADVERSE EFFECTS ON
PUPAE AND ADULTS OF THE MONARCH BUTTERFLY WERE REPORTED IN THIS STUDY.
POSSIBLE ADVERSE EFFECTS ON NON-TARGET LEPIDOPTERA THROUGH THE
CONSUMPTION OF ANTHERS FROM BT MAIZE PLANTS (ANDERSON ET AL. 2004, FELKE
& LANGENBRUCH 2005) AND ESPECIALLY THE COMBINED EFFECTS OF POLLEN AND
ANTHERS OF BT MAIZE CONTAINING THE BT TOXIN (ANDERSON ET AL. 2005) HAVE
SO FAR NOT BEEN TAKEN INTO CONSIDERATION. ALSO LEPIDOPTERA OTHER THAN
THE MONARCH BUTTERFLY HAVE BEEN SHOWN TO SUFFER SUBLETHAL OR LETHAL
EFFECTS WHEN EXPOSED TO BT MAIZE (VOJTECH ET AL. 2005, DUTTON ET AL.
2005). IT IS STILL UNCERTAIN WHICH OTHER NON-TARGET BUTTERFLIES MIGHT BE
ADVERSELY AFFECTED BY THE CONSUMPTION OF BT CORN POLLEN OR ANTHERS.
OUT OF 215 BUTTERFLY SPECIES OCCURRING IN AUSTRIA, 152 SPECIES HAVE BEEN
REPORTED FROM AGRICULTURAL AREAS AND MORE THAN HALF OF THOSE SPECIES ARE
ALREADY CLASSIFIED AS EITHER NEAR THREATENED, VULNERABLE, ENDANGERED OR
CRITICALLY ENDANGERED (TRAXLER ET AL. 2005). TRAXLER ET AL. (2005)
FURTHER SHOW THAT DEVELOPMENT OF THESE BUTTERFLIES DOES COINCIDE WITH
THE TIME OF POLLEN SHED OF CULTIVATED MAIZE FOR 75 - 100% OF THE TIME IN
CASE OF 29 BUTTERFLY SPECIES. SHORTER OVERLAPS OF RESPECTIVE TIMEFRAMES
ARE SEEN WITH THE OTHER BUTTERFLY SPECIES: 25% OVERLAP FOR 51 SPECIES,
UP TO 50% OVERLAP FOR ANOTHER 59 SPECIES AND 50 - 75% FOR 5 SPECIES.
BASED ON A NUMBER OF CHARACTERISTICS (DEVELOPMENTAL OVERLAP WITH
FLOWERING TIME OF MAIZE, ECOLOGICAL CHARACTERISTICS OF BUTTERFLIES,
INCIDENCE OF ENDANGERED SPECIES, BIODIVERSITY OF BUTTERFLY SPECIES) A
RISK-INDEX FOR BUTTERFLIES WAS DEDUCED AND SHOWS THAT AREAS IN AUSTRIA,
WHERE INSECT RESISTANT GM MAIZE VARIETIES ARE POTENTIALLY GROWN, ARE IN
THE VICINITY OF AREAS, WHICH ARE CHARACTERISED BY HIGH BIODIVERSITY OF
BUTTERFLIES AND A HIGH NUMBER OF ENDANGERED BUTTERFLY SPECIES (TRAXLER
ET AL. 2005).
THEREFORE IN CONCLUSION WE EXPECT IT TO BE LIKELY THAT BUTTERFLY SPECIES
WHICH ARE ALREADY ENDANGERED WOULD BE ADDITIONALLY AFFECTED BY
CULTIVATION OF GM MAIZE MON810. SINCE ADDITIONAL IMPACTS ON ENDANGERED
SPECIES SHOULD BE MINIMISED THE CULTIVATION OF GM MAIZE MON810 IS
EXPECTED TO HAVE NEGATIVE EFFECTS.
2.3.2. EFFECTS ON OTHER NON-TARGET ORGANISMS
CONCERNING THE IMPORTANT ASPECT OF POTENTIAL ADVERSE EFFECTS ON
DIFFERENT CLASSES OF NONTARGET ORGANISMS A STUDY ON THE META-ANALYSIS OF
AVAILABLE DATA ON FIELD TRIALS FROM DIFFERENT SOURCES WAS PUBLISHED
RECENTLY (MARVIER ET AL. 2007). THIS WORK USES AVAILABLE DATA ON EFFECTS
OF BT TOXINS ON DIFFERENT GROUPS OF ARTHROPOD INSECTS. TO ANALYSE
EFFECTS OF CRY1A(B) TOXIN AS CONTAINED IN GM MAIZE MON810 DATA ON
ABUNDANCE OF COLEOPTERA, HEMIPTERA, HYMENOPTERA, ARANAE, NEUROPTERA,
DIPTERA, THYSANOPTERA AND COLLEMBOLA IN ADDITION TO LEPIDOPTERA WERE
ANALYSED. FOR ALL KINDS OF CRY1A(B) EXPRESSING GM MAIZE VARIETIES THE
OVERALL MEAN ABUNDANCE OF NON-TARGET INVERTEBRATES WAS SIGNIFICANTLY
LOWER FOR THE GM-VARIETIES COMPARED TO CONTROL OF NON-GM MAIZE VARIETIES
WHICH WERE NOT TREATED WITH INSECTICIDES. THIS FORM OF COMPARISON IS
RELEVANT TO ASSESS ANY DIFFERENCES OF THE POTENTIAL CULTIVATION OF GM
MAIZE MON810 WITH CONVENTIONAL VARIETIES GROWN UNDER CONDITIONS OF
ORGANIC AGRICULTURE AND REDUCED INSECT MANAGEMENT BY INSECTICIDES. THESE
MANAGEMENT PRACTICES ARE FAVOURED BY THE AUSTRIAN NATIONAL PLANS FOR
IMPLEMENTATION OF ECO-FRIENDLY AGRICULTURE. SPECIFIC ADDITIONAL FUNDING
TO FARMERS IN AUSTRIA IS CONNECTED TO APPLICATION OF SUCH MANAGEMENT
PRACTICES.
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SIGNIFICANT EFFECTS OF CRY1A(B) TOXIN EXPRESSING GM MAIZE ARE FOUND
SPECIFICALLY FOR HYMENOPTERA AND COLLEMBOLA. SPECIFIC DATA FOR GM MAIZE
MON810 ALSO SHOW A LOWER AVERAGE ABUNDANCE OF NON-TARGET INVERTEBRATE
SPECIES ON PLOTS OF GM MAIZE MON810 COMPARED WITH UNTREATED PLOTS OF
NON-MODIFIED MAIZE, BUT WITH A LOWER LEVEL OF SIGNIFICANCE.
ANOTHER OVERVIEW ON RESULTS CONCERNING THE POTENTIAL ADVERSE EFFECTS OF
GM PLANTS EXPRESSING BT TOXINS LIKE GM MAIZE MON810 WAS PUBLISHED BY
LOEVEI & ARPAIA (2005). THEY CONCLUDED THAT PARAMETERS CONNECTED TO
DEVELOPMENT, GENERAL BIOLOGY, OR FITNESS OF PREDATING INSECTS, LIKE
SURVIVAL/MORTALITY, DEVELOPMENT TIME, BODY MASS/SIZE, PREY CONSUMPTION,
REPRODUCTION, LONGEVITY, EGG VIABILITY OR BEHAVIOUR, WERE NEGATIVELY
AFFECTED IN 41 % OF THE FEEDING TESTS (IN 30% OF CASES SIGNIFICANTLY
NEGATIVE). AN ANALYSIS OF THE RESPECTIVE RESULTS FOR FEEDING TESTS WITH
PARASITOIDS SHOWED COMPARABLE DATA (LOEVEI & ARPAIA 2005). EVEN
CONSIDERING THE FACT THAT WORST CASE SCENARIO TESTING METHODS WERE NOT
CONSISTENTLY APPLIED AND MANY IMPORTANT SPECIES HAVE NOT BEEN TESTED AT
ALL, THIS DOES CONSTITUTE A CLEAR INDICATION THAT MOST LIKELY NEGATIVE
EFFECTS HAVE TO BE EXPECTED.
IN THE REPORT BY MARVIER ET AL. (2007) THE AUTHORS CONSISTENTLY FOUND
RELEVANT DEFICIENCIES WITH REGARD TO THE ORIGINAL DATA. SPECIFICALLY
THEY REPORTED THAT OUT OF 64 STUDIES ANALYSED
40% OF REPORTS DID NOT INDICATE THE VARIANCE FOR THE REPORTED
TREATMENT MEANS, 22% USED THE SUBSAMPLES IN AN IMPROPER WAY TO
CALCULATE MEASURES OF VARIANCE AND FOR 20% OF THE REPORTS THE SAMPLE
SIZES WERE NOT CLEARLY PRESENTED.
THEY INDICATED THAT SOME OF THESE INSUFFICIENCIES COULD BE CLARIFIED BY
ADDITIONAL INFORMATION SUBMITTED BY THE AUTHORS UPON REQUEST. THEIR
CONCLUSION TOWARDS THESE DEFICIENCIES IS THAT REGULATORY AGENCIES SHOULD
REQUIRE SUBMITTING THE DATA ON FIELD TESTS IN AN ADEQUATELY STRUCTURED
WAY, TO BE ABLE TO SPOT ANY LACKING INFORMATION WHICH IS CRUCIAL FOR AN
ADEQUATE ASSESSMENT. ANY APPROVALS SHOULD BE POSTPONED UNTIL COMPLETE
SETS OF DATA HAVE BEEN SUBMITTED AND ASSESSED. SINCE SIMILAR DATA WERE
USED FOR THE PRECEDING RISK ASSESSMENTS OF GM MAIZE MON810, THE
CONCLUSIONS DRAWN IN THESE ASSESSMENTS SHOULD BE REGARDED AS TENTATIVE
AND SUBJECT TO REVIEW BASED ON ASSESSMENT OF ADEQUATE DATA.
BT TOXIN EXPOSITION OF NON-TARGET ORGANISMS OF HIGHER TROPHIC LEVELS
LIKE PREDATORS AND PARASITOIDS HAS BEEN DOCUMENTED IN RECENT STUDIES
(HARWOOD ET AL. 2005; ZWAHLEN & ANDOW 2005; OBRIST ET AL. 2006). FOR
SOME OF THESE SPECIES A LOWER ABUNDANCE ON PLOTS OF BT MAIZE VARIETIES
HAS BEEN REPORTED (E.G. PILCHER ET AL. 2005; BOURGUET ET AL. 2002). ANY
LARGE-SCALE APPLICATION OF GM MAIZE MON810 WOULD THUS LEAD TO
EXACERBATED EFFECTS ON SPECIFIC NATURAL ENEMIES OF MAIZE PEST INSECTS.
EFFECTS ON WATER DWELLING ORGANISMS
THE EFFECT OF THE BT-TOXIN INCORPORATED IN GM MAIZE MON810 ON AQUATIC
NON-TARGET SPECIES WAS NOT SPECIFICALLY CONSIDERED BY THE NOTIFIER AND
DURING THE PRECEDING RISK ASSESSMENTS (SEE E.G. SCP 1998). A RECENT
PUBLICATION (ROSI-MARSHALL ET AL. 2007) REPORTS ADVERSE EFFECTS ON
AQUATIC INSECT SPECIES AND THEIR DATA SUBSTANTIATE THE PREVIOUSLY
HYPOTHESISED RISK POTENTIAL THAT MATERIAL DERIVED FROM GM MAIZE MON810
CONTAINING THE CRY1A(B) PROTEIN COULD AFFECT THE FOOD CHAIN IN AQUATIC
ENVIRONMENTS. THUS ANY COMPREHENSIVE RISK ASSESSMENT NEEDS TO ALSO TAKE
INTO ACCOUNT EFFECTS ON WATER-DWELLING INSECTS.
THE NECESSARY ASSESSMENT OF SPECIFIC EFFECTS OF GM MAIZE MON810 CANNOT
BE BASED ON DATA CONCERNING EFFECTS OF INSECTICIDAL SPRAYS PRODUCED FROM
BACILLUS THURINGIENSIS VAR. ISRAELENSIS (BTI) ON AQUATIC ENVIRONMENTS.
DUE TO DIFFERENCES IN EXPOSURE AND THE NATURE OF BT PROTEINS PRESENT IN
BTI THE PREVIOUS ASSESSMENTS OF BTI CANNOT BE REGARDED OF HIGH
SIGNIFICANCE FOR ASSESSING THE RISK OF BT-TOXINS DERIVED FROM GM MAIZE
MON810 (HERSHEY
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ET AL. 1998, PONT ET AL. 1999, AND JACKSON ET AL. 2002 AS CITED IN
ROSI-MARSHALL ET AL. 2007). THE RISK ASSESSMENT MUST BE BASED ON STUDIES
DIRECTLY EVALUATING THE SPECIFIC EFFECTS OF GM MAIZE MON810 ON AQUATIC
NON-TARGET SPECIES. RECENTLY A STUDY ADDRESSING SUCH ADVERSE EFFECTS HAS
BEEN PUBLISHED FOR CERTAIN TRICHOPTERA SPECIES, WHICH CAN CONSUME
MATERIAL DERIVED FROM GM MAIZE MON810 CULTIVATED IN THE VICINITY OF
AQUATIC ECOSYSTEMS (ROSI-MARSHALL ET AL. 2007).
THE RESULTS DO DEMONSTRATE THAT MATERIAL DERIVED FROM GM MAIZE MON810 IN
AGRICULTURAL ENVIRONMENTS IS DEPOSITED IN NEIGHBOURING AQUATIC
ECOSYSTEMS AND AVAILABLE TO AQUATIC INSECTS OF DIFFERENT FEEDING
BEHAVIOUR, LIKE CERTAIN WATER-DWELLING TRICHOPTERA SPECIES (FILTER
FEEDING AND LEAF-SHREDDING TRICHOPTERAN GROUPS). THESE INSECTS ARE
FEEDING ON MATERIAL CONTAINING BT-TOXIN AND DO INGEST BT-TOXIN FROM THIS
SOURCE IN DETECTABLE AND RELEVANT QUANTITIES. AS A SUPPORTING LINE OF
EVIDENCE LABORATORY FEEDING TESTS WITH THESE TRICHOPTERA SPECIES
DEMONSTRATE THAT INGESTED BT-TOXIN DOES LEAD TO ADVERSE EFFECTS, LIKE
SIGNIFICANTLY REDUCED GROWTH RATES OF LEAF-SHREDDING TRICHOPTERA SPECIES
AND ELEVATED MORTALITY RATES OF SPECIES FEEDING ON ALGAL BIOFILMS, WHICH
CONTAIN POLLEN FROM GM MAIZE MON810. THE EFFECTS ARE PLAUSIBLE GIVEN THE
CLOSE RELATIONSHIP OF TARGET LEPIDOPTERA AND THE TRICHOPTERA ANALYSED IN
THE STUDY. ADVERSE EFFECTS ON AQUATIC SPECIES LIKE TRICHOPTERA WILL
PREDICTABLY REDUCE THE BIOMASS AVAILABLE FOR PREDATING SPECIES AND
THEREFORE HAVE RELEVANT EFFECTS ON AQUATIC FOOD-WEBS AND BIOTA IN
AGRICULTURAL AREAS, WHERE GM MAIZE MON810 IS CULTIVATED.
SIMILAR TO THE SITUATION AS ENCOUNTERED AT THE SITES OF SAMPLING IN
ROSI-MARSCHALL ET AL. (2007) MAIZE IS CULTURED IN AUSTRIA IN CLOSE
VICINITY TO AQUATIC ECOSYSTEMS AS DESCRIBED IN AN ASSESSMENT OF HABITATS
FOUND IN TYPICAL AREAS OF MAIZE CULTIVATION, E.G. IN CARINTHIA
(WUTSCHEIN/THON), UPPER AUSTRIA (METTENSDORF), BURGENLAND (KOTEZICKEN),
AND LOWER AUSTRIA (EBREICHSDORF) (HEISSENBERGER ET AL. 2004).
ADDITIONALLY MATERIAL CONTAINING CRY1AB TOXIN FROM GM MAIZE MON810 COULD
BE INTRODUCED INTO AQUATIC ECOSYSTEMS FROM MANURE USED AS ORGANIC
FERTILISER AND MAIZE MATERIAL FROM SILAGE (MALITZKY 2007). FURTHERMORE
TRICHOPTERA SPECIES RELATED TO THE ONES ANALYSED IN THE ABOVE MENTIONED
STUDY DO ALSO OCCUR IN AUSTRIA. SPECIFICALLY 19 SPECIES OF
HYDROPSYCHIDAE AND FOUR SPECIES OF LEPIDOSTOMATIDAE WERE REPORTED FOR
AUSTRIA (GRAF ET AL. 2002). THEREFORE SIMILAR ADVERSE EFFECTS AS
DEMONSTRATED IN THE ABOVE MENTIONED RESEARCH HAVE TO BE EXPECTED IN
AUSTRIA RESULTING FROM ANY CULTIVATION OF GM MAIZE MON810.
WITH REGARD TO THE DATA ON TRICHOPTERA DISTRIBUTION IN AUSTRIA IT IS
EVIDENT THAT THERE IS A TWOFOLD RISK FOR THIS GROUP OF AQUATIC SPECIES
BY THE BT TOXINS AS CONTAINED IN GM MAIZE MON810: A NUMBER OF
TRICHOPTERA SPECIES IS CURRENTLY ENDANGERED IN AUSTRIA AND ADDITIONAL
ADVERSE EFFECTS BY GM MAIZE MON810 ON THEIR POPULATION ARE RELEVANT AS
EXPLICITLY MENTIONED BY MALITZKY (2007). SPECIFICALLY MORE THAN HALF OF
THE HYDROPSYCHIDAE AND LEPIDOSTOMIDAE SPECIES (THE GROUPS OF TRICHOPTERA
EXAMINED IN ROSI-MARSCHALL ET AL. (2007) FOR ADVERSE EFFECTS) ARE LISTED
AS ENDANGERED IN AUSTRIA. THREE OF THOSE SPECIES ARE RECOGNISED AS
HIGHLY ENDANGERED OR EVEN CRITICALLY ENDANGERED (MALITZKY 2007). THESE
ENDANGERED SPECIES ARE VULNERABLE AGAINST ADDITIONAL NEGATIVE EFFECTS,
LIKE ANY ADVERSE EFFECTS BY GM MAIZE MON810. SECONDLY SOME OTHER
TRICHOPTERA SPECIES ARE VERY ABUNDANT AND THEREFORE
IMPORTANT SOURCES OF PREY FOR AQUATIC PREDATORS, E.G. FISH. ADVERSE
EFFECTS OF THE CULTIVATION OF GM MAIZE MON810 AS DESCRIBED IN
ROSI-MARSCHALL ET AL. (2007) WOULD IMPACT ON THIS FOOD WEB AND THUS
NEGATIVELY AFFECT HIGHER TROPHIC LEVELS OF THE EXPOSED AQUATIC
ECOSYSTEMS.
SINCE ANY UNDESIRED IMPAIRMENT OF AQUATIC HABITATS SHOULD BE AVOIDED,
THE POTENTIAL EFFECT OF GM MAIZE MON810 ON THESE ECOSYSTEMS HAS TO BE
REGARDED AS RELEVANT, CONSIDERING THAT IT IS UNKNOWN DUE TO LACKING DATA
WHICH ADDITIONAL EFFECTS THE CULTIVATION OF GM MAIZE MON810 MIGHT HAVE
ON AQUATIC ECOSYSTEMS.
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2.3.3. EFFECTS ON NON-TARGET SOIL ORGANISMS
ACCORDING TO THE NOTIFIER RISKS TO SOIL ORGANISMS AND SOIL FUNCTION
THROUGH DEGRADATION OF GM PLANT MATERIAL OR RISKS THROUGH CONTAMINATION
OF GROUND WATER ARE CONSIDERED TO BE EXTREMELY LOW.
HOWEVER A RANGE OF INFORMATION WAS LEFT UNCONSIDERED IN PREVIOUS
ASSESSMENTS. THE ACTUAL RATES AND DEGRADATION PROCESSES FOR LARGE
PROTEINS IN SOILS ARE POORLY UNDERSTOOD. THERE IS EVIDENCE THAT BT MAIZE
RELEASES THE BT TOXIN IN ROOT EXUDATES (SAXENA ET AL. 2004). UNDER THE
AUSTRIAN CONDITIONS THE EXPOSURE OF SOIL ORGANISMS TOWARDS CRY1AB TOXIN
FROM GM MAIZE MON810 COULD BE SUBSTANTIALLY HIGHER AS ASSUMED BY THE
NOTIFIER. RECENT DATA INDICATE THAT BT MAIZE DECOMPOSES SLOWER IN THE
SOIL THAN NON-BT PLANTS (FLORES ET AL. 2005). THEREFORE THE BT TOXIN
LOAD IN MAIZE FIELDS CAN BE SUBSTANTIAL, WHICH MAKES LARGESCALE EFFECTS
POSSIBLE. FURTHERMORE RESULTS SHOW THAT THE BT TOXIN CAN PERSISTS IN
SOIL FOR MONTHS RETAINING ITS INSECTICIDAL ACTIVITY (SAXENA & STOTZKY
2002, STOTZKY 2004). THIS IS RELEVANT FOR THE ASSESSMENT OF ADVERSE
EFFECTS OF BT TOXINS RELEASED INTO THE SOIL. ADSORBED TO SOIL MINERALS
THE BT TOXIN IN ACTIVE FORM CAN BE DETECTED LONGER THAN 200 DAYS AND
THUS PERSISTS LONGER THAN THE VEGETATION PERIOD OF MAIZE PLANTS (CECCIO
& STOTZKY, 2001, ZWAHLEN ET AL. 2003A). THE AMOUNTS OF BT TOXINS
DELIVERED TO THE SOIL ARE MOST PRONOUNCED WITH GM PLANTS LIKE BT-COTTON
AND BT-MAIZE (CLARK ET AL. 2005). CRY1AB TOXIN IS RELEASED FROM THE
ROOTS OF GM MAIZE PLANTS AND CAN ACCUMULATE IN THE RHIZOSPHERE TO
RELEVANT CONCENTRATIONS (SAXENA & STOTZKY 2005).
ADVERSE EFFECTS FOR SOIL LIVING NON-TARGET ORGANISMS WERE DISCUSSED IN A
SUBSTANTIAL NUMBER OF RECENT PUBLICATIONS (ANDOW & HILBECK 2004, DALE ET
AL. 2002, HILBECK 2001, LIU ET AL. 2005, MARVIER 2001, ZWAHLEN ET AL.
2003A AND 2003B). SPECIFICALLY HERBIVOROUS AND DETRIVOROUS ORGANISMS
WOULD BE EXPOSED TO BT TOXINS FROM GM MAIZE MON810, AS WELL AS PREDATING
SPECIES FEEDING ON EXPOSED ORGANISMS.
A DIRECT IMPACT IS AN INHIBITORY EFFECT FOR THE FORMATION OF SYMBIONTIC
FUNGAL COMMUNITIES IN THE ROOTS OF HIGHER PLANTS BY THE MYCORRHIZA FUNGI
(CASTALDINI ET AL. 2005). SOIL LIVING ARTHROPODS ARE INGESTING THE
CRY1AB TOXIN AND SHOW VARIOUS ADVERSE EFFECTS: EARTHWORMS SHOW A
DECREASE IN THEIR WEIGHT AFTER 200 DAYS EXPOSITION (ZWAHLEN ET AL.
2003B) AND DEVELOPMENTAL DEFECTS (REDUCED HATCHING RATES) (VERECSI ET AL
2006). ADDITIONALLY OTHER SOIL ORGANISMS LIKE NEMATODES AND ISOPODS DO
SHOW NEGATIVE EFFECTS (GROWTH DEPRESSION, LOWER FOOD INTAKE) UPON
EXPOSITION TO CRY1AB TOXIN FROM GM MAIZE MON810 (GRIFFITHS ET AL. 2006;
WANDELER ET AL. 2002). ANOTHER GROUP WHICH IS POSSIBLY AFFECTED ARE
INSECT LARVAE E.G. CERTAIN CARABIDAE WHICH WOULD FEED ON MATERIAL
DERIVED FROM GM MAIZE MON810 (LANGENBRUCH ET AL. 2006). MEISSLE ET AL.
(2005) SHOWED THAT CARABID LARVAE SHOWED ELEVATED MORTALITY WHEN FED ON
SPODOPTERA REARED WITH GM MAIZE CONTAINING CRY TOXINS.
TAKEN TOGETHER EVIDENCE IS AVAILABLE TO SHOW THAT THE RISK FOR SOIL
ORGANISMS IS RELEVANT UNDER REGIONAL AUSTRIAN CONDITIONS. SINCE HEALTHY
SOILS ARE A PREREQUISITE FOR LOW-INPUT AGRICULTURE AND ORGANIC
AGRICULTURE, THE POTENTIAL EFFECTS OF THE CULTIVATION OF GM MAIZE MON810
ARE LIKELY LEADING TO A NEGATIVE IMPACT ON SOIL QUALITY.
3. ASSESSMENT OF ECONOMIC CONSEQUENCES DUE TO OUTCROSSING AND
ADVENTITIOUS PRESENCE
THE EFSA GUIDANCE DOCUMENT ON RISK ASSESSMENT OF GMOS DOES NOT TAKE INTO
CONSIDERATION THE ECONOMIC EFFECTS OF CULTIVATION OF GENETICALLY
MODIFIED PLANTS AND THEREFORE OFFERS NO GUIDANCE FOR NOTIFIERS AND
ASSESSORS ON THESE ISSUES. HOWEVER SUCH AN ASSESSMENT IS REQUIRED WITH A
VIEW TO THE POTENTIAL EFFECTS OF THE CULTIVATION OF GM PLANTS AND IS IN
LINE WITH THE ISPM-GUIDANCE BY THE INTERNATIONAL STANDARD SETTING BODY
IPPC, WHICH IS RECOGNISED BY THE WTO.
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ACCORDING TO THIS INTERNATIONALLY AGREED GUIDANCE THE ECONOMICAL
CONSEQUENCES OF THE POTENTIAL CULTIVATION OF GM MAIZE MON810 (OR GM
MAIZE T25 RESPECTIVELY) IN AUSTRIA ARE ASSESSED AS FOLLOWS:
CULTIVATION OF GM MAIZE MON810 (OR GM MAIZE T25) IS EXPECTED TO LEAD TO
CROSSFERTILISATION OF OTHER VARIETIES OF MAIZE GROWN ON NEIGHBOURING
PLOTS SPECIFICALLY UNDER THE CONDITIONS OF THE AUSTRIAN AGRICULTURAL
ENVIRONMENT (SEE CHAPTER 2.1 FOR REFERENCE). THIS EFFECT IS RELEVANT
SPECIFICALLY FOR THE GROWERS OF NON-MODIFIED VARIETIES, SPECIFICALLY OF
ORGANICALLY GROWN MAIZE.
IN AUSTRIA AN AMOUNT OF 1.72 MIO TONNES (T) GRAIN MAIZE AND 3.54 MIO T
MAIZE FOR SILAGE WERE PRODUCED IN 2005. AS PART OF THE OVERALL AMOUNT 34
204 T GRAIN MAIZE WAS PRODUCED ACCORDING TO THE PROVISIONS OF ORGANIC
AGRICULTURE (BMLFUW, 2007). MAIZE FOR PRODUCTION OF GRAINS AND COB-CORN
MIX (CCM) WAS PLANTED ON 181 196 HA, MAIZE FOR SILAGE ON 78 655 HA. FOR
CERTIFIED ORGANIC PRODUCTION 6 024 HA WERE PLANTED TO PRODUCE GRAIN AND
CCM MAIZE, 1 664 HA FOR PRODUCTION OF SILAGE MAIZE.
IN AUSTRIA ADDITIONALLY 4 306 HA OF THE MAIZE PRODUCTION AREA WERE
DEDICATED TO THE PRODUCTION OF MAIZE SEEDS IN 2006. IN THE SAME YEAR
ORGANIC MAIZE SEEDS WERE PRODUCED ON 165 HA. IN SOME REGIONS OF AUSTRIA
THE PRODUCTION OF SEEDS AND THE PRODUCTION OF MAIZE FOR CONSUMPTION ARE
SITUATED IN CLOSE NEIGHBOURHOOD.
SPECIFIC DATA FOR UPPER AUSTRIA AS AN EXAMPLE OF A REGION WITH A HIGH
PROPORTION OF MAIZE PRODUCTION THE TOTAL ACREAGE FOR MAIZE ARE SUPPLIED
IN THE FOLLOWING:
IN 2006 MAIZE WAS GROWN ON 66 777 HA WITH 414 478 T GRAIN AND CCM
MAIZE AND 1 111 085 T MAIZE SILAGE PRODUCED (BMLFUW, 2007). IN 2004 AN
AREA OF 21 379 HA WAS CULTIVATED WITH FIELD CROPS ACCORDING TO ORGANIC
STANDARDS (AT 2 386 FARMS). MOST OF THE FARMS ARE QUITE SMALL WITH LESS
THAN 5 HA
ARABLE LAND/FARM. ORGANIC MAIZE WAS CULTIVATED AT 142 FARMS ON 551 HA
(AVERAGE ACREAGE OF 3.9 HA/FARM). ABOUT 1 000 HA OF MAIZE WERE PLANTED
2004 UNDER SPECIFIC CONTRACTS AS CERTIFIED
GM-FREE PRODUCE FOR THE PRODUCTION OF 10 000 T MAIZE FOR PRODUCTION OF
STARCH IN UPPER AUSTRIA. PRODUCTION OF SPECIALITY MAIZE WAS ALSO ONGOING
IN THE FOLLOWING YEARS.
FOR THE PRODUCTION OF SEEDS AS WELL AS FOR THE ORGANICALLY PRODUCED
MAIZE AND GMO-FREE MAIZE THE THRESHOLD LEVEL FOR ADVENTITIOUS PRESENCE
OF GM MAIZE IS SET TO 0.1 %, BEING THE TECHNICAL LIMIT FOR DETECTION OF
GM PRESENCE (BMLFUW 2001; CODEX ALIMENTARIUS AUSTRIACUS 1998).
THE DIFFERENCE IN PRICES FOR ORGANICALLY GROWN MAIZE VERSUS CONVENTIONAL
MAIZE IS 157 EURO/T (395 EURO/T VS. 238 EURO/T) AS OF OCTOBER 2007
(RAIFFEISEN WARE AUSTRIA). THIS DIFFERENCE IN CURRENT PRICES IS
SUBSTANTIAL FOR THE PRODUCERS: A 40 % LOSS OF INCOME ON SALES HAS TO BE
EXPECTED IN CASE THE INDICATED THRESHOLDS FOR GM-FREE PRODUCE (INCLUDING
ORGANIC PRODUCE) ARE EXCEEDED AS A CONSEQUENCE OF OUT-CROSSING FROM GM
MAIZE MON810. A COMPARABLE DIFFERENCE DOES EXIST BETWEEN MAIZE THAT CAN
BE SOLD AS SEED AND MAIZE SOLD FOR CONSUMPTION PURPOSES. THEREFORE ANY
PRODUCERS OF SEED, ORGANICALLY PRODUCED MAIZE AND PRODUCERS OF SPECIAL
PRODUCE, WHICH IS CERTIFIED TO BE GMO-FREE WILL ACCRUE SEVERE LOSSES OF
INCOME IN CASE THE PRESENCE OF GM MAIZE IN THEIR PRODUCE EXCEEDS A
MARGIN OF 0.1 %.
WITH THE CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 THE FEASIBILITY
FOR PRODUCTION OF GM-FREE MAIZE WILL CERTAINLY BECOME INCREASINGLY
DIFFICULT AND COSTLY. ADDITIONALLY TO ANY UNEXPECTED LOSS OF INCOME IN
CASE OF CONTAMINATION OF PRODUCE THROUGH OUT-CROSSING FROM NEIGHBOURING
FIELDS THE EXPENSES FOR QUALITY-CONTROL OF ORGANIC FARMERS WILL
CERTAINLY RISE. TO GIVE A REPRESENTATIVE EXAMPLE FOR THE COSTS THAT HAVE
TO BE TAKEN INTO ACCOUNT FOR THE SCREENING OF PRODUCE FOR CONTENT OF
GM-MAIZE INCLUDING GM MAIZE MON810 OR GM MAIZE
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T25, RESPECTIVELY: SUCH ANALYSES FOR DETECTION OF GM MAIZE CURRENTLY
COST 195 EURO/SAMPLE AT THE TESTING FACILITY OF THE AUSTRIAN FEDERAL
ENVIRONMENT AGENCY (UMWELTBUNDESAMT 2007). PRICES IN OTHER FACILITIES
ARE COMPARABLE BY A MARGIN OF 20 %. DEMAND FOR ANALYTICAL DETECTION TO
CERTIFY THAT THE PRODUCE IS MEETING THE REQUIRED STANDARDS IS EXPECTED
TO INCREASE SUBSTANTIALLY.
FURTHERMORE IT WILL BE NECESSARY TO INTRODUCE ADDITIONAL PROCEDURES TO
AVOID CONTAMINATION OF PRODUCE AT HARVEST AND AFTERWARDS ONCE GM MAIZE
MON810 OR GM MAIZE T25 ARE CULTIVATED: CLEANING PROCEDURES FOR
HARVESTERS AND OTHER NECESSARY MACHINERY INVOLVED IN
HARVEST AND TRANSPORT, SPECIFIC SEGREGATION SYSTEMS FOR SHIPMENT AND
STORAGE FOR MAIZE CROPS SUCH ADDITIONAL MEASURES WILL CERTAINLY LEAD TO
LOSS OF PRODUCTION OF GMOFREE PRODUCE AS WELL AS ADDITIONAL RELEVANT
EXPENSES FOR SETUP AND MAINTAINING SUCH MEASURES AS SHOWN BY MERTENS &
SCHIMPF (2006). SIMILAR SUBSTANTIAL COSTS HAVE TO BE EXPECTED IN THE
AUSTRIAN CONDITIONS.
IN CONCLUSION THE CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 ON
PLOTS DISTRIBUTED THROUGHOUT AUSTRIA WILL HAVE SEVERE AND DRAMATIC
ECONOMIC CONSEQUENCES FOR THE PRODUCERS OF GM-FREE MAIZE AND MAIZE SEED.
IN CASE CONTAMINATION LEVELS SHOULD APPROACH THE 0.9 % THRESHOLD, THE
PRODUCE WOULD HAVE TO BE LABELLED AS GM-MATERIAL LEADING TO FURTHER
ECONOMIC CONSEQUENCES. THE ASSESSMENT THUS SHOWS THAT ADOPTION OF
CULTIVATION OF GM MAIZE MON810 OR GM MAIZE T25 IN AUSTRIA WILL VERY
LIKELY HAVE SEVERE ECONOMIC CONSEQUENCES.
4. ENVIRONMENTAL MONITORING PLAN
THIS CHAPTER COVERS ISSUES RELATED TO AN ENVIRONMENTAL MONITORING PLAN
AS OUTLINED IN THE EFSA GUIDANCE DOCUMENT IN ANNEX III, CHAPTER D.10.
THESE ISSUES FOR RISK ASSESSMENT CORRESPOND TO THE GUIDANCE FOR
MONITORING OF DELIBERATE RELEASES OF GMOS AND THE PLACING ON THE MARKET
AS DETAILED IN DIR. 2001/18/EC, ANNEX VII. INDIVIDUAL REFERENCE FOR THE
ISSUES RELEVANT TO THE PRESENTED ASSESSMENT IS GIVEN BELOW AND INDICATED
IN PARENTHESIS WITH REGARD TO THE STRUCTURE OUTLINED BY EFSA.
4.1 GENERAL ASPECTS (D 10.1)
ACCORDING TO DIRECTIVE 2001/18/EC EACH NOTIFICATION OF A GMO MUST
CONTAIN A PLAN FOR MONITORING IN ACCORDANCE WITH ANNEX VII WITH THE AIM
TO CONFIRM THE ASSUMPTIONS FROM THE RISK ASSESSMENT AND TO IDENTIFY THE
OCCURRENCE OF ADVERSE EFFECTS OF THE GMO OR ITS USE ON HUMAN HEALTH OR
THE ENVIRONMENT WHICH WERE NOT ANTICIPATED IN THE RISK ASSESSMENT.
HOWEVER, A MONITORING PLAN ACCORDING TO THE MENTIONED STANDARDS HAS NOT
BEEN PROVIDED BY THE NOTIFIER. SPECIFICALLY THE ABSENCE OF EFFECTS ON
NON-TARGET ORGANISMS, WHICH WAS STATED BY THE NOTIFIER IN THE RISK
ASSESSMENT, AS WELL AS THE POSSIBLE OCCURRENCE OF SECONDARY PESTS SHOULD
BE SUBJECT TO A MONITORING IN LINE WITH THE REQUIREMENTS LAID DOWN IN
DIRECTIVE 2001/18/EC AS WELL AS THE GUIDANCE BY THE EFSA GMO PANEL.
4.2 CASE-SPECIFIC GM PLANT MONITORING (D.10.3)
THE MAIN OBJECTIVE OF CASE-SPECIFIC MONITORING IS TO DETERMINE THE
SIGNIFICANCE OF ANY ADVERSE EFFECTS IDENTIFIED IN THE ENVIRONMENTAL RISK
ASSESSMENT. IN THIS RESPECT THE LACK OF A MONITORING PLAN FOR
CULTIVATION OF GM MAIZE MON810 TAKING INTO ACCOUNT THE CONDITIONS FOR
USE AND CULTIVATION IN AUSTRIA ARE CONSIDERED A MAIN DEFICIENCY.
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FIRSTLY THIS CONFLICTS WITH THE CURRENT OBLIGATIONS FOR SUCH PRODUCTS.
ANNEX VII OF DIRECTIVE 2001/18/EC MUST BE CONSIDERED AS AGREED MINIMUM
STANDARD FOR THIS ISSUE. ON THE OTHER HAND, SUCH A MONITORING SCHEME
WOULD BE NECESSARY TO ADDRESS THE ISSUE OF SECONDARY PESTS, A QUESTION
CONSIDERED IMPORTANT BY THE SCIENTIFIC COMMITTEE ON PLANTS IN THEIR
OPINION ON THE SAFEGUARD MEASURE FOR GM MAIZE MON810, BUT NOT TAKEN INTO
ACCOUNT ADEQUATELY IN THE PRECEDING ASSESSMENTS.
THE PRESENTED RISK ASSESSMENT IDENTIFIED TWO KINDS OF POTENTIALLY
ADVERSE EFFECTS ON THE ENVIRONMENT THAT HAVE TO BE COVERED IN AN
ADEQUATE CASE-SPECIFIC MONITORING STRATEGY:
POTENTIAL RESISTANCE DEVELOPMENT OF TARGET INSECT SPECIES AND
EFFECTS ON NON-TARGET ORGANISMS IN DIFFERENT HABITATS.
ADDITIONALLY RECENT INVESTIGATIONS OF BT COTTON CULTIVATION IN CHINA
HAVE SHOWN AN EXTRAORDINARY INCREASE OF OTHER PEST SPECIES SUCH AS LEAF
BUGS (WU ET AL. 2002) AND CONSEQUENTLY A RISE IN PESTICIDE APPLICATIONS
(WANG ET AL. 2006). HOWEVER, SECONDARY PESTS WERE NEITHER CONSIDERED IN
THE RISK ASSESSMENT NOR IN A MONITORING PLAN. THEREFORE THE EFFECTS OF
BT CROP CULTIVATION ON OTHER PESTS AND THE DEVELOPMENT OF SECONDARY
PESTS AND CONSEQUENTLY THE ADDITIONAL USE OF SYNTHETIC PLANT PROTECTION
PRODUCTS SHOULD BE MONITORED FOR APPLICATIONS OF BT CROPS.
4.3 GENERAL SURVEILLANCE OF THE IMPACT OF THE GM PLANT (D.10.4)
IN ADDITION TO THE CASE SPECIFIC MONITORING A GENERAL SURVEILLANCE PLAN
IS NECESSARY ACCORDING TO DIR. 2001/18/EC, ANNEX VII AS WELL AS
ACCORDING TO GUIDANCE BY THE EFSA GMO PANEL. THE PLAN SHOULD BE DIRECTED
TO IDENTIFY ANY UNEXPECTED ADVERSE EFFECTS OF THE APPLICATION OF GM
MAIZE MON810 IN ADDITION TO EFFECTS COVERED BY CASE SPECIFIC MONITORING.
THE LACK OF A DETAILED AND EFFECTIVE GENERAL SURVEILLANCE PLAN MUST BE
REGARDED A MAJOR DEFICIENCY OF THE APPLICATION AND INADEQUATE WITH A
VIEW TO ADDRESSING THE CONCERNS THAT HAVE BEEN PUT FORWARD AGAINST THIS
APPLICATION.
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IMAGE 35
DAS ZIEL DIESES BERICHTS IST, DIE OESTERREICHISCHEN ARGUMENTE IM WTO-FALL
"EUROPEAN COMMUNITIES - MEASURES AFFECTING THE APPROVAL AND MARKETING OF
BIOTECH PRODUCTS" ZUSAMMEN ZU FASSEN. DIE OESTERREICHISCHEN
SCHUTZKLAUSELN, MIT DENEN DER IMPORT UND DIE ANWENDUNG DER GENTECHNISCH
VERAENDERTEN MAISLINIEN MON810 UND T25 VERBOTEN WIRD, WAREN TEIL DER
BEKLAGTEN EU-MASSNAHMEN IM GENANNTEN STREITFALL. DIESER BERICHT ERFUELLT
DIE WTO KRITERIEN HINSICHTLICH DER FORDERUNG, DASS DIESE MASSNAHMEN AUF
EINER RISIKOABSCHAETZUNG BASIEREN MUESSEN, DIE DEM SPS ABKOMMEN ENTSPRICHT
UND NACH RICHTLINIEN VON INTERNATIONALEN STANDARDISIERUNGSORGANISATIONEN
DURCHGEFUEHRT WURDE.
BESTELLTELEFON: 01/711 00-4700 |
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| discipline | Agrarwissenschaft Chemie-Ingenieurwesen Biotechnologie Pflanzenbau |
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| id | DE-604.BV023247183 |
| illustrated | Not Illustrated |
| index_date | 2024-07-02T20:26:22Z |
| indexdate | 2024-07-09T21:14:02Z |
| institution | BVB |
| isbn | 9783902611079 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016432620 |
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| physical | 31 S. |
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| series2 | Forschungsberichte der Sektion IV / Bundesministerium für Gesundheit, Familie und Jugend, Sektion IV |
| spelling | Eckerstorfer, Michael Verfasser aut Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report Michael Eckerstorfer ; Andreas Heissenberger ; Helmut Gaugitsch Wien 2007 31 S. txt rdacontent n rdamedia nc rdacarrier Forschungsberichte der Sektion IV / Bundesministerium für Gesundheit, Familie und Jugend, Sektion IV 2007,4 Zsfassung in dt. Sprache Risikoanalyse (DE-588)4137042-9 gnd rswk-swf Maissorte (DE-588)4280736-0 gnd rswk-swf Transgene Pflanzen (DE-588)4311513-5 gnd rswk-swf Maissorte (DE-588)4280736-0 s Transgene Pflanzen (DE-588)4311513-5 s Risikoanalyse (DE-588)4137042-9 s b DE-604 Heissenberger, Andreas Verfasser aut Gaugitsch, Helmut Verfasser aut Bundesministerium für Gesundheit, Familie und Jugend, Sektion IV Forschungsberichte der Sektion IV 2007,4 (DE-604)BV022482249 2007,4 OEBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016432620&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Eckerstorfer, Michael Heissenberger, Andreas Gaugitsch, Helmut Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report Risikoanalyse (DE-588)4137042-9 gnd Maissorte (DE-588)4280736-0 gnd Transgene Pflanzen (DE-588)4311513-5 gnd |
| subject_GND | (DE-588)4137042-9 (DE-588)4280736-0 (DE-588)4311513-5 |
| title | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report |
| title_auth | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report |
| title_exact_search | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report |
| title_exact_search_txtP | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report |
| title_full | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report Michael Eckerstorfer ; Andreas Heissenberger ; Helmut Gaugitsch |
| title_fullStr | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report Michael Eckerstorfer ; Andreas Heissenberger ; Helmut Gaugitsch |
| title_full_unstemmed | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize report Michael Eckerstorfer ; Andreas Heissenberger ; Helmut Gaugitsch |
| title_short | Supplementary risk assessment for GM maize MON 810 with regard to the conclusions of the WTO-Panel in the case "EC Biotech" on Austrian safeguard measures for GM maize |
| title_sort | supplementary risk assessment for gm maize mon 810 with regard to the conclusions of the wto panel in the case ec biotech on austrian safeguard measures for gm maize report |
| title_sub | report |
| topic | Risikoanalyse (DE-588)4137042-9 gnd Maissorte (DE-588)4280736-0 gnd Transgene Pflanzen (DE-588)4311513-5 gnd |
| topic_facet | Risikoanalyse Maissorte Transgene Pflanzen |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016432620&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV022482249 |
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