commercialisation of agricultural products derived … · "the commercialisation of agricultural...
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OECDENVIRONMENTMONOGRAPH
No. 99
COMMERCIALISATION OF AGRICULTURAL PRODUCTSDERIVED THROUGH MODERN BIOTECHNOLOGY:
SURVEY RESULTS
Environment Directorate
in co-operation with the
Directorate for Food, Agriculture and Fisheries
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris 1995
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Also published in the Environment Monograph series:
Environment Monograph No. 100, ComparativeAnalysis of Data Elements Used in the Assessmentof Certain Products of Modern Biotechnology(1995)
Environment Monograph No. 107, Report of theOECD Workshop on the Commercialisation ofAgricultural Products Derived through ModernBiotechnology (1995)
© OECD 1995
Applications for permission to reproduce or translate all or part of this material should be made to:Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France
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ENVIRONMENT MONOGRAPHS
The Environment Monograph series makestechnical documents prepared by the OECDEnvironment Directorate available to the public.For a complimentary copy of this document,contact the Environmental Health and SafetyDivision, OECD Environment Directorate, 2 rueAndré-Pascal, 75775 Paris Cedex 16, France.
Fax: (33-1) 45 24 16 75
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Foreword
"The Commercialisation of Agricultural Products Derived through ModernBiotechnology" is a joint project of the OECD’s Environment Policy Committee and Committeeon Agriculture. The project’s objective is to assist countries in their regulatory oversight ofagricultural products derived through modern biotechnology – specifically in their efforts toensure safety, to make oversight policies more transparent and efficient, and to facilitate trade.Its focus is on the review of national policies, with respect to regulatory oversight, that willaffect the movement of these products into the marketplace.
The first activity of this project was a survey focusing on national policies withregard to regulatory oversight of agricultural products of biotechnology. Questions ondata elements used in safety reviews, and on mechanisms for data assessment, wereincluded. A questionnaire was distributed to OECD Member countries and 16 additionalcountries ("Participating countries") which take part in the OECD Scheme for VarietalCertification of Seed Moving in International Trade. A total of 23 countries responded: 16Member countries and seven Participating countries. The results are published in thisEnvironment Monograph.
Subsequently the United States hosted an OECD Workshop on 3-4 June 1994 withthe aims of: improving awareness and understanding of the various systems of regulatoryoversight developed for agricultural products of biotechnology; identifying similarities anddifferences in various approaches; and identifying the most appropriate role for the OECD infurther work towards harmonization of these approaches. Information collected in the surveywas presented as a basis for discussions. Approximately 80 experts in the areas ofenvironmental biosafety, food safety and varietal seed certification, representing 16 Membercountries, eight non-Member countries, the European Commission and several internationalorganizations, participated in the Workshop (see Environment Monograph No. 107, Report ofthe OECD Workshop on the Commercialisation of Agricultural Products Derived throughModern Biotechnology).
Derestriction of the survey results was recommended by the Joint Meeting of theChemicals Group and the Management Committee of the Special Programme on the Controlof Chemicals, and by the Committee on Agriculture. This Environment Monograph is beingpublished on the responsibility of the Secretary-General of the OECD.
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Table of Contents
Résumé . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Survey Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Summary of Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Overview of Regulatory Oversight Systems . . . . . . . . . . . . . . . . . . . . . . . . . . 18Environmental Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Varietal Registration and Seed Certification . . . . . . . . . . . . . . . . . . . . . . . . . . 21Responsible Ministries/Agencies and National Expert Committees . . . . . . . . . . 22Laws/Regulations and Field Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Field Trial Authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Diagrams of National Regulatory Oversight Processes . . . . . . . . . . . . . . . . . . 23Tally of Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Annexes
OECD Country Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Participating Country Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Annex I: Overview of Regulatory Oversight Systems (Table 1) . . . . . . . . . . . . . . . . 29
Annex II: Environmental Biosafety
Part A Data Elements Used in Environmental Biosafety Reviews . . . . . . 39
Characteristics of Donor Organisms (Table 2a)Characteristics of Recipient Plants (Table 2b)Character of the Modified Plant (Table 2c)Human Health Considerations (Table 2d)Environmental and Agronomic Considerations (Table 2e)
Part B Mechanisms for Data Assessment (Table 3) . . . . . . . . . . . . . . . . 59
Annex III: Food Safety Data Considerations (Table 4) . . . . . . . . . . . . . . . . . . . . . . . . 67
(continued next page)
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Annex IV: Varietal Registration and Seed Certification . . . . . . . . . . . . . . . . . . . . . . . 75
Part A Varietal Registration Requirements and Useof OECD Seed Certification Schemes (Table 5) . . . . . . . . . . . . . 75
Part B Seed Certification Requirements (Table 6) . . . . . . . . . . . . . . . . . 81
Annex V: Responsible Ministries/Agencies and National Expert Committees(Table 7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Annex VI: Laws/Regulations and Field Testing (Table 8) . . . . . . . . . . . . . . . . . . . . . . 97
Annex VII: Field Trial Authorisations (Table 9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Annex VIII: Diagrams of National Regulatory Oversight Processes . . . . . . . . . . . . . . 111
Annex IX: Tally of Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Overview of Regulatory Oversight Systems (Table 10) . . . . . . . . . . . . . . 131
Environmental Biosafety Data Considerations (Table 11) . . . . . . . . . . . . . 133
Food Safety Data Considerations (Table 12) . . . . . . . . . . . . . . . . . . . . . . 135
Varietal Registration and Seed Certification Information(Table 13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Annex X: Questionnaire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
I. General Approach to Oversight of Products of ModernBiotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
II. Environmental Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
III. Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
IV. Varietal Registration and Seed Certification . . . . . . . . . . . . . . . . . . 164
V. Case Studies for Crop Plants Derived through ModernBiotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
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Résumé
Le présent rapport contient les résultats d’une enquête de l’OCDE consacrée en1993-1994 à la Commercialisation des produits agricoles issus de la biotechnologie moderne.Cette enquête a été réalisée dans le cadre d’un projet mené sous les auspices conjointes duComité des politiques d’environnement et du Comité de l’agriculture. Un questionnairecorrespondant a été diffusé aux pays Membres de l’OCDE et à seize autres pays quiparticipent au Système de l’OCDE pour la certification variétale des semences (appelés paysparticipants). Seize pays Membres de l’OCDE et sept pays participants aux programmesrelatifs au Système de l’OCDE pour les semences ont répondu à l’enquête. Celle-ci portait surles politiques nationales en matière de surveillance/réglementation de ces produits. Lesbesoins de données concernant les produits issus de la biotechnologie moderne, ainsi queles mécanismes d’évaluation des données, entraient également dans le cadre de l’enquête.
Dans l’ensemble, les réponses à l’enquête ont donné une image du champ couvertpar les cadres et dispositifs juridiques adoptés par les pays répondants pour réglementer lesproduits des techniques biologiques appliquées à l’agriculture. Des variations considérablesont été relevées dans l’expérience acquise par différents pays où de nouveaux produitsagricoles faisant appel à la biotechnologie sont en cours de mise au point. L’enquête anéanmoins révélé un degré relativement élevé de similitude dans les éléments pertinents dedonnées pris en compte dans les dispositifs nationaux de surveillance/réglementation.
Le questionnaire était divisé en cinq parties : Méthode générale de surveillance desproduits issus de la biotechnologie moderne ; Sécurité biologique de l’environnement ;Sécurité des denrées alimentaires ; Enregistrement variétal et certification des semences etÉtudes de cas.
Les données réunies lors de l’enquête doivent faire l’objet de séminaires de l’OCDE.Le premier séminaire a eu lieu les 2 et 3 juin 1994 à Washington, D.C. Il est prévu d’enorganiser d’autres. Ces réunions visent globalement à offrir aux pays participants un forumoù ils pourront mieux connaître et mieux comprendre les divers dispositifs de surveillanceréglementaire mis au point pour les produits agricoles issus de la biotechnologie, appréhenderles similitudes et les différences entre les diverses approches et définir le rôle le mieuxapproprié à l’OCDE dans la poursuite des travaux visant à l’harmonisation, tout en évitant desdoubles emplois avec les travaux réalisés dans d’autres enceintes. On pourrait commencerà établir des mécanismes permettant de partager les données entre tous les pays participantset à élaborer des orientations pour la détermination et l’évaluation des données appropriées.
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Introduction
This Environment Monograph presents the results of a 1993-1994 OECD survey onthe "Commercialisation of Agricultural Products Derived through Modern Biotechnology". Thesurvey, carried out as part of a joint project of the Environment Policy Committee and theCommittee on Agriculture, focused on national policies with respect to regulatory oversight ofagricultural products derived through modern biotechnology. Questions on data elements usedin reviews of these products, and mechanisms for data assessment, were included in thesurvey.
A questionnaire was distributed to OECD Member countries and 16 additionalcountries that participate in the OECD Scheme for Varietal Certification of Seed Moving inInternational Trade (referred to throughout this document as "Participating countries"). A totalof 23 countries (16 OECD countries and seven Participating countries) responded.
It was planned that the survey results would be used as a basis for discussions atsubsequent OECD workshops. The first of these workshops took place on 2-3 June 1994 inWashington, D.C. Other workshops will be organized. The overall objective of theseworkshops will be to provide a means for countries to: improve awareness and understandingof the various regulatory oversight systems for agricultural products of biotechnology; identifysimilarities and differences in various approaches; and identify the most appropriate role forthe OECD in further work towards harmonization, while avoiding duplication of workundertaken by other fora. Mechanisms for data sharing, and the development of guidance fordata identification and evaluation, may be initiated.
Survey Method
The questionnaire (included as Annex X of this document) was distributed inSeptember 1993. It is divided into five sections: General Approach to Oversight of Productsof Modern Biotechnology; Environmental Biosafety; Food Safety; Varietal Registration andSeed Certification; and Case Studies.
The types of information requested in each section are as follows:
Part I, General Approach to Oversight of Products of Modern Biotechnology:
1) Are specific regulatory oversight structures in place to accommodate theproducts of agricultural biotechnology?
2) Which governmental bodies have responsibility for various aspects of theregulatory oversight of these products, and how are their activities co-ordinated?
3) What are the general objectives of the national biotechnology regulatoryoversight policy?
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4) Are there national expert committees and, if so, what is their role?
5) What forms of international guidance are recognized as aids to theregulatory oversight of these products?
6) What non-regulatory issues are relevant for consideration in thecommercialisation of these products?
Part II, Environmental Biosafety:
1) Are there structures allowing field testing and commercialisation of theseproducts?
2) What laws/regulations/policies apply?
3) What types of field trials of transgenic crop plants have taken place?
4) What considerations are relevant to regulatory oversight of crop plants atvarious developmental stages on the way to commercialisation, with respectto: the donor organism; the recipient organism; the modified plant itself;human health; and environmental and agronomic considerations?
5) What forms of data are accepted and how are the data assessed foradequacy/quality?
6) What forms of guidance are available to developers of the new crop varieties?
7) Does assessment of potential benefits figure in the overall evaluation of atransgenic crop plant for field testing?
8) Are data or experience from other countries accepted in environmentalbiosafety review?
9) Have simplified procedures for regulatory oversight of field testing beenadopted and, if so, on what basis?
10) What types of transgenic agricultural crop plants have already beencommercialised or are expected to be commercialised shortly?
11) What relationships exist between the environmental biosafety system and thesystems for ensuring food safety and the varietal registration and seedcertification systems?
Part III, Food Safety:
1) Are biotechnology products for food or feed use regulated using the samemechanisms as those used for conventional products? If not, what othermechanisms are used?
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2) What laws/regulations/policies apply?
3) What forms of data are accepted, and how are the data assessed foradequacy/quality?
4) What forms of guidance are available to developers of the new food or feed?
5) Are data from other countries accepted in food safety review?
6) Are there specific regulations for composition and nutritional value of food?
7) What scientific considerations are relevant in the food safety review of a foodproduct derived from a transgenic crop plant?
8) Does assessment of potential benefits figure in the overall evaluation of thesafety of food products derived from transgenic crop plants?
9) What relationships exist between the food safety system and the varietalregistration and seed certification systems?
Part IV, Varietal Registration and Seed Certification:
1) Is there a system for varietal registration?
2) What laws/regulations/policies apply and who administers them?
3) What characteristics are reviewed for varietal registration?
4) Must varieties be sold as certified seed? If so, which varieties?
5) Are portions or all of the OECD seed certification system used domesticallyor in international commerce?
6) Are other seed certification systems in use domestically?
7) Is your country a signatory to the UPOV1 convention?
8) What kinds of additional data or seed testing will be required for seed fromtransgenic crop varieties?
Part V of the questionnaire, Case Studies for Crop Plants Derived through ModernBiotechnology, addressed four such plants nearing commercialisation in several countries.The case studies selected were: herbicide-resistant canola/oilseed rape; delayed ripening(antisense) tomato [with kanamycin selectable marker]; insect-resistant (Bt) maize/corn; andvirus-resistant (coat protein) sugar beet. The questionnaire asked what were likely to be themost significant considerations in evaluations of environmental biosafety and food safety for
1 Union internationale pour la Protection des Obtentions Végétales (International Union for theProtection of New Varieties of Plants).
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each plant. It also asked what standard was likely to be applied in evaluating acceptable risklevel. With respect to varietal registration and seed certification, it asked whether additionalissues would need to be considered and whether additional testing would be required.
As specified in the questionnaire, the case study responses have not been presentedin this document. However, the information provided by responding countries may be usedin the aggregate as a basis for discussion at relevant OECD workshops.
A controlled vocabulary was used in the questionnaire in order to make responsescomparable between countries. The vocabulary for comparing data elements in environmentalbiosafety reviews was derived from the "Blue Book", Recombinant DNA Safety Considerations(published by the OECD in 1986).
It was recognized that some terms might differ from those used routinely inresponding countries. Although opportunities were provided for respondents to mentionfactors outside this controlled vocabulary, certain components of national regulatory oversightprocedures may not have been captured to a full extent. For example, "scale-up" was notconsidered a separate developmental stage for all products in all countries. An apparentabsence of regulatory oversight at "scale-up" would not, however, mean that such field trialswere unregulated, but rather that they were regulated as for either a "prior" or "succeeding"stage.
Summary of Responses
Sixteen OECD countries responded to the survey: Australia, Austria, Belgium,Canada, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway,Sweden, Switzerland, the United Kingdom and the United States.
Seven "Participating countries" responded: Argentina, Chile, the Czech Republic,Hungary, Morocco, the Slovak Republic and South Africa. These countries participate in theOECD Scheme for Varietal Certification of Seed Moving in International Trade.
Overall, the responses provided a picture of the scope of legal frameworks andapproaches adopted by these countries to regulate the products of agricultural biotechnology.Countries’ experience with new agricultural biotechnology products under development variedwidely. Nonetheless, the survey indicated a relatively high degree of similarity in the dataelements considered in national regulatory oversight systems.
Responses are presented in the annexes:
• Annex I gives an overview of national regulatory oversight systems that are, orwill be, utilized for the products of agricultural biotechnology (Table 1).
• Annex II, part A concerns data elements used in environmental biosafety review(Tables 2a-2e); part B concerns mechanisms for data assessment (Table 3).
• Annex III summarizes responses regarding food safety data (Table 4).
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• Annex IV, part A summarizes responses with respect to characteristics reviewedin varietal registration and the use of OECD Seed Schemes (Table 5); part Blists, country-by-country, crops that require seed certification (Table 6).
• Annex V lists ministries or agencies responsible for various types of regulatoryoversight as well as national expert committees (Table 7).
• Annex VI lists laws, regulations or policies in place and summarizes responsesregarding field trials that had occurred at the time of the survey (Table 8).
• Annex VII lists field trial authorisations according to crop plant (Table 9).
• Annex VIII contains diagrams furnished by several countries to illustrate theirregulatory oversight procedures.
• Annex IX is a tally (by total number of OECD and Participating countries) ofresponses to a number of questions relating to national regulatory oversightsystems (Tables 10-13).
• Annex X contains the questionnaire itself.
In the tables, responses from OECD countries are presented first with those fromParticipating countries following directly after. The tables showing Participating countries’responses are marked with double asterisks (**). For consistency this arrangement is usedthroughout the document, even in those sections relating to seed certification. (OECD andParticipating countries are equal participants in OECD Seed Schemes.)
In general, the tables in the annexes follow the format of the sections of thequestionnaire to which they correspond.
All countries did not answer every question. Dashes (–) indicate that countries didnot respond to particular questions. Where countries had additional comments, this isindicated by notes [e.g. "(a)"] in the tables. The comments are found in the "Footnotes"section at the end of the annex.
In several instances, countries submitted official policy statements or copies ofregulations instead of filling out a section of the questionnaire. To avoid misinterpreting thismaterial, such responses have been considered as non-replies for the purposes of thisdocument.
The following is a general overview of countries’ responses, rather than adetailed description of all the information in the annexes. Users of this document maywant to refer to the questionnaire in Annex X. For more information on OECD SeedSchemes, please contact the OECD’s Directorate for Food, Agriculture and Fisheries.
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Overview of Regulatory Oversight Systems
General features of national regulatory oversight systems, and basic information oncountries’ environmental biosafety, food safety, and varietal registration and seed certificationsystems are summarized in Annex I (Table 1).
Twelve of the 23 responding countries had a regulatory oversight system specificallyfor agricultural crop plants derived through modern biotechnology. Six countries had a modifiedform of an existing regulatory oversight system. New regulatory oversight systems were underdevelopment in three countries.
National expert committees had been established in nearly all countries to deal withproducts of agricultural biotechnology. All but one of these committees in OECD countries, andmost of those in Participating countries, operated in an advisory context. In two Participatingcountries, they had mixed advisory and executive roles.
In all OECD and Participating countries, several agencies/ministries sharedresponsibilities for regulatory oversight of products of agricultural biotechnology. However,there were formal mechanisms for co-ordinating oversight of these products in fewer than halfthe countries.
Simplified procedures for the oversight of field testing of transgenic crop plants hadbeen adopted by eight OECD countries and two Participating countries. Simplifications weregenerally aimed at reducing paperwork for regulatory oversight agencies and for applicants.
Benefits associated with crop plants derived through agricultural biotechnology weretaken into account in relation to environmental biosafety review in eleven countries. Thereappeared to be some confusion as to the meaning of the question concerning when benefitsassessments occurred in the review process (see page 157, question 5). Responses to thisquestion have therefore not been reported.
All the OECD countries had a regulatory oversight system for food safety that wouldapply to the products of agricultural biotechnology. Six of these countries used the samesystem as that for conventional products; four countries had a food safety regulatory oversightsystem specifically for biotechnology products; and six used a modified form of the systemexisting for conventional products. Three Participating countries used the same food safetyregulatory oversight system for the products of agricultural biotechnology as for conventionalproducts, and one anticipated using a modified form of the system for conventional products.
Over half the OECD countries specifically addressed the safety of feed derived fromthe products of agricultural biotechnology. Seven of them used the same feed safety systemfor conventional products and for products derived through biotechnology; two countries hadbiotechnology-specific regulatory oversight; and two countries used a modified form of thesystem for conventional products. Participating countries used the same type of regulatoryoversight approaches for feed as those identified for food.
Ten OECD countries had specific regulations for the composition and nutritional valueof conventional food products, as did three of the four responding Participating countries.
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The concept of "substantial equivalence" (see page 163, question 5) was used in foodsafety review in twelve OECD countries and two Participating countries, although one OECDcountry pointed out that the term had no legal status.
In nine OECD countries and two Participating countries, food safety evaluations tookinto account benefits gained through the use of biotechnology. Approaches or considerationscited by countries as being relevant to benefits analysis (see page 163, question 6) included:the ability to make available foods that had not previously been used for human consumption,with lowered toxin levels; comparison with conventionally produced foods; case-by-case review;use of benefits analysis based on data (including nutritional and toxicological studies) fromsafety assessment for all novel foods, not only those produced through biotechnology; andconsideration of benefits with respect to new pesticidal substances.
All countries had systems for registering new crop varieties, although the system inone OECD country was voluntary. All but two countries were signatories to the UPOVConvention.2
Nineteen countries required varieties to be sold as certified seed.
All countries used at least one of the listed OECD seed certification schemes (seepage 165, question 4) for international commerce. Eight countries used at least one OECDseed certification scheme for domestic seed certification.
Seventeen countries had national seed certification systems which might be used inaddition to OECD seed certification schemes.
Environmental Biosafety
The information summarized in Annex II (Tables 2 and 3) concerns the environmentalbiosafety data elements potentially used in reviews of crop plants produced throughbiotechnology. As presented, this information does not take into consideration the case-by-case nature of reviews of products of agricultural biotechnology. Depending on the particularmodification, not all the data elements mentioned may be relevant or required.
The questionnaire contained an extensive listing of data elements that might be usedin four designated review areas: conventional crop plant; transgenic crop plant in research anddevelopment (small-scale); transgenic crop plant in scale-up release; and transgenic crop plantproduct for commercial field planting (see page 150, question 3). Data needs in these reviewareas were somewhat difficult to survey for two reasons:
1) countries appeared to interpret the meaning of the review areas differently; and
2) not all of the review areas were recognized as separate stages by all countries.
2 See note on page 15.
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For the sake of clarity, therefore, Table 2 does not distinguish between data neededfor reviews in these four areas up to commercialisation. There were considerable differencesin the data elements reported as used in field testing in the research and development (small-scale) and scale-up release review areas, perhaps due at least partly to differences ininterpreting the meaning of the different review areas. However, there was less differenceamong countries in regard to the aggregate data set needed by the time a product is to becommercialised.
Data elements used to make environmental and agronomic evaluations were generallythose on which there was greatest agreement: most of the data elements listed wereconsidered relevant by most countries. There was also considerable agreement on dataelements used for the character of the modified plant and the characteristics of the recipientplant. There was less agreement on data requirements for several aspects of donor organismcharacteristics and human health considerations.
There was wide agreement on the kind of information that could be used to meet dataneeds. Scientific literature, published test data, and history of use were accepted in allcountries. Three countries indicated that other types of information besides those listed in thequestionnaire (see page 156, question 4) were also used.
All the countries that responded to this part of the questionnaire identified ways toassess data for adequacy and/or quality. Those most frequently cited were national expertcommittee review and ministry/agency internal review. Public comment and IBC (institutionalbiosafety committee) review were used less often. Three countries cited other mechanisms forensuring data quality.
There were recommended methods, protocols or guidance on testing to generate newdata in six OECD countries and three Participating countries. Of these, guidance was availablemost often.
Most countries did not identify particular methods of evaluating the quality of test data.However, of the methods listed, field inspection and the experience/capability of the notifierwere considered most often. Six countries specified other means.
Simplified procedures for oversight of field testing had been adopted in eight OECDcountries and two Participating countries. Thirteen OECD countries and three Participatingcountries indicated factors on which such simplified procedures should be based (pages 157-158, question 6).
Food Safety
The information summarized in Annex III (Table 4) pertains to countries’ food safetydata considerations. Sixteen countries examined at least three out of four of the areas listed(allergenicity, toxicity, contamination and nutrition) in food safety review of food productsderived from transgenic crop plants (see page 161, question 2). Seven countries examinedadditional areas.
Eight OECD countries indicated that data elements needed to assess food productsderived through agricultural biotechnology differed from those for conventional food products.
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No Participating countries indicated that these data requirements differed. Additional datarequirements listed in at least one response (see page 162, question 2) included: assessmentof similarity to conventional foods or to parental organisms; case-by-case review; determinationof chemical composition and foreign DNA sequence; determination of genetic stability;determination of integration site of new DNA; performance of feeding studies when there wasinsufficient knowledge about integration site; and provision of safety information from field trials.
Fourteen OECD countries and four Participating countries identified kinds ofinformation accepted to meet data requirements. Scientific literature, published test data, andhistory of use were identified by nearly all countries.
Fourteen OECD countries and three Participating countries identified mechanisms forassessing the adequacy and/or quality of data. The mechanisms most frequently cited wereministry/agency internal review and national expert committee review. Public comment wasidentified as a mechanism in three OECD countries, but not in any of the Participatingcountries.
About half the responding countries did not have recommended methods, protocolsor guidance for testing to generate new data in order to establish food safety. In countries thathad them, guidance was the most frequently available.
Eleven OECD countries, but no Participating countries, used Good Laboratory Practicecriteria for food safety testing. One Participating country indicated that other methods ofensuring the quality of safety testing were used.
About as many OECD countries used the initial safety assessment of a food productfor the purpose of feed safety review as required a new assessment for feed safety.
Varietal Registration and Seed Certification
In Annex IV (Tables 5 and 6) information pertaining to varietal registration and seedcertification is presented separately for OECD countries and Participating countries, to beconsistent with the rest of the document. However, all these countries are equal participantsin OECD Seed Schemes.
As indicated above, there were varietal registration systems in all countries, but oneof these systems was voluntary. All countries reviewed, at a minimum, distinctness, uniformityand stability. All used at least one of the listed OECD Seed Schemes for internationalcommerce. Eight countries used at least one OECD Seed Scheme for domestic seedcertification. The most commonly used schemes both internationally and domestically were forherbage and oil seed, cereal, maize, sugar beet and fodder beet (see page 165, question 4).
Additional characteristics and data requirements foreseen by at least one country forregistration and seed certification of transgenic crop plants (see page 166, question 7)included: food safety assessment; identification of genetic markers for purity of variety testing;approval by a designated authority; information concerning the gene and its expression;information on benefits, effect, stability, and environmental impact; information on compliancewith GMO regulations, information on how the plasmid was introduced into the plant, its
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stability, and the probable modified action in the environment; data concerning human, animaland environmental biosafety; data on biology of the crop; data making identification of theintroduced gene(s) possible or potential special tests for new characteristics not covered bycurrent procedures; data on horizontal gene transfer, possible side effects, and agronomicbenefits; and information on gene patents.
Additional kinds of testing foreseen by at least one country for seed from transgenicvarieties (see page 166, question 8) included: RFLPs or AFLPs for purity of variety testing;new means of virus testing in virus-resistant crops; PCR analysis; cytological or gelelectrophoretic tests; and certain toxicological tests, if necessary.
Responsible Ministries/Agencies and National Expert Committees
Ministries and agencies with regulatory oversight responsibilities for agriculturalbiotechnology products, as well as national expert committees, are listed in Annex V (Table 7)(refer also to the footnotes at the end of Annex I).
Laws/Regulations and Field Testing
Pertinent laws, regulations and policies are listed in Annex VI (Table 8) (refer also tothe footnotes at the end of Annex I).
Information on the number of field trials with transgenic crop plants conducted in eachcountry is also summarized in Table 8. However, the number of field trials is not comparablebetween countries, as what is considered a single field trial can vary from country to country.There may be differences, for example, in the number of sites that are considered part of thesame field trial, or in whether renewed applications of the same organism at a site, or trials ofextended duration, constitute new trials.
Field Trial Authorisations
Field trial authorisations are listed by crop plant in Annex VII (Table 9). Geneticmodifications are grouped into categories such as insect resistance, herbicide tolerance, andproduct quality. Abbreviations of OECD countries are given first, followed by those ofParticipating countries (in brackets). Owing to the difficulty of comparing numbers of field trials,no numerical data are presented.
A total of 40 crops had been authorized for field testing. Field trials with 26 of themhad taken place in the United States. There had been authorisations for trials with more thantwo different crop species in 13 OECD countries and in three Participating countries. Threecrops (bird’s foot trefoil, crown vetch and wheat) had been authorised for testing only inParticipating countries.
22
-
Genetically modified potatoes had been field tested in the greatest number of countries(13 OECD countries and one Participating country), followed by modified oilseed rape/canola/spring rape (ten OECD countries and three Participating countries), corn/maize (nine OECDcountries and two Participating countries), beet/sugar beet (eight OECD countries and twoParticipating countries), tomato (seven OECD countries and one Participating country), cotton(two OECD countries and two Participating countries), and soybean (two OECD countries andtwo Participating countries).
Diagrams of National Regulatory Oversight Processes
Diagrams supplied by countries to illustrate their regulatory oversight processes arereproduced in Annex VIII (see pages 143 and 144, question 4).
Tally of Responses
Responses to some of the survey questions are tallied (by total number of OECD andParticipating countries) in Annex IX (Tables 10-13). Several have not been presented in theother annexes in country-by-country form. They include:
Maintaining standards of human, animal and environmental health and safety wasidentified most often as an underlying objective of national biotechnology regulatory oversightstructures. Around half the countries also identified addressing a public concern, and aroundtwo-thirds identified dealing with the safety, efficacy and performance of new products (seepage 143, question 3).
Each of the identified OECD principles, concepts, and guidelines (i.e. GoodDevelopmental Principles, Good Industrial Large-scale Practice, the concept of "substantialequivalence", and Principles for Scale-up) was used by at least half the OECD countries. TheGood Developmental Principles and Principles for Scale-Up were used most often (seepage 146, question 6).
Most of the OECD countries indicated that two of the non-regulatory issues identifiedin the questionnaire should be considered in the commercialisation of agricultural productsderived through biotechnology. These issues were: public perception and acceptance, andfood labelling. Over half the OECD countries indicated that development of pest resistanceand intellectual property rights should be considered. About half the Participating countriesindicated that each of the non-regulatory issues identified in the questionnaire should beconsidered (see page 146, question 8).
At least 15 of the 16 OECD countries accepted data from other OECD countries withrespect to environmental biosafety, and eleven accepted food safety data. Four Participatingcountries accepted environmental biosafety data and three accepted food safety data.
23
-
24
-
ANNEXES
25
-
26
-
OECD COUNTRY ABBREVIATIONS
AS
AU
BE
CA
DE
FR
GE
IT
JA
NE
NZ
NO
SWE
SWI
UK
US
AUSTRALIA
AUSTRIA
BELGIUM
CANADA
DENMARK
FRANCE
GERMANY
ITALY
JAPAN
THE NETHERLANDS
NEW ZEALAND
NORWAY
SWEDEN
SWITZERLAND
UNITED KINGDOM
UNITED STATES
27
-
PARTICIPATING COUNTRY ABBREVIATIONS
AR
CH
CZ
HU
MO
SL
SA
ARGENTINA
CHILE
CZECH REPUBLIC
HUNGARY
MOROCCO
SLOVAK REPUBLIC
SOUTH AFRICA
28
-
Annex I:
Overview of Regulatory OversightSystems
29
-
30
-
31
TA
BL
E1.
OV
ER
VIE
WO
FR
EG
UL
AT
OR
YO
VE
RS
IGH
TS
YS
TE
MS
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Gen
eral
Appr
oach
1.G
ener
alR
egul
ator
yO
vers
ight
Syst
em4(
a)2(
c)5
45
45
54(
j)5
55
5(m
)2(
p)5
4(w
)
2.N
atio
nalE
xper
tCom
mitt
eeye
sno
(d)
yes
yes
-ye
sye
sye
sye
sye
sye
sye
sye
sye
s(q)
yes
yes
3.C
o-or
dina
tion
ofAg
ricul
tura
lBi
otec
hnol
ogy
Activ
ities
yes(
b)no
noye
s(f)
yes
yes
yes(
h)ye
s(i)
no(k
)no
-no
nono
(n)
yes(
s)ye
s(x)
Envi
ronm
enta
lBio
safe
ty
4.R
egul
ator
yO
vers
ight
forR
esea
rch
and
Dev
elop
men
tye
sno
(d)
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no(n
)ye
sye
s
5.R
egul
ator
yO
vers
ight
forS
cale
-up
yes
no(d
)ye
sye
sye
sye
s-
yes
noye
sye
sye
sye
sno
(n)
yes
yes(
y)
6.R
egul
ator
yO
vers
ight
for
Com
mer
cial
isat
ion
nono
(d)
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no(n
)no
(n)
yes
yes(
z)
7.Si
mpl
ified
Proc
edur
esfo
rOve
rsig
htof
Fiel
dTe
stin
gno
noye
s(e)
yes(
g)ye
sye
sno
yes
noye
s(l)
-no
nono
yes(
t)ye
s(aa
)
8.Be
nefit
sAn
alys
isye
sno
noye
sye
sye
sno
yes
noye
sye
sno
nono
nono
(bb)
Food
Safe
ty
9.R
egul
ator
yO
vers
ight
forF
ood
34
34
54
54
35
45
34
3(u)
3
10.R
egul
ator
yO
vers
ight
forF
eed
-5
-4
33
34
3-
-5
3(o)
-3(
v)3
11.R
egul
atio
nsfo
rCom
posi
tion
and
Nut
ritio
nalV
alue
ofC
onve
ntio
nal
Prod
ucts
yes
yes
yes
yes
-no
no-
nono
yes
yes
yes
yes(
r)ye
sye
s(cc
)
12.U
seof
"Sub
stan
tialE
quiv
alen
ce"
yes
yes
yes
yes
yes
yes
yes
noye
sno
yes
yes
--
yes
yes(
dd)
13.B
enef
itsAn
alys
isye
sno
yes
yes
-ye
sye
sno
noye
sye
sye
sno
noye
sno
CODE
S:
1.no
over
sigh
tsys
tem
2.ov
ersi
ghts
yste
mcu
rrent
lyun
derd
evel
opm
ent
3.sa
me
over
sigh
tsys
tem
asfo
rcon
vent
iona
lpro
duct
s4.
sam
eov
ersi
ghts
yste
mas
forc
onve
ntio
nalp
rodu
cts,
butm
odifi
edfo
rbio
tech
nolo
gypr
oduc
ts5.
spec
ific
over
sigh
tsys
tem
forb
iote
chno
logy
prod
ucts
-
32
TA
BL
E1.
OV
ER
VIE
WO
FR
EG
UL
AT
OR
YO
VE
RS
IGH
TS
YS
TE
MS
(co
nti
nu
ed)
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Varie
talR
egis
tratio
nan
dSe
edCe
rtific
atio
n
14.V
arie
talR
egis
tratio
nSy
stem
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
-ye
sye
sye
sye
sno (e
e)
15.R
equi
rem
entt
hatV
arie
ties
BeSo
ldas
Cer
tifie
dSe
edno
yes
yes
yes
yes
yes
yes
yes
yes
yes
-ye
sye
sye
sye
sno
16.U
seof
OEC
DSe
edC
ertif
icat
ion
Sche
mes
Dom
estic
yes
yes
nono
no-
noye
sye
sno
-no
nono
nono
Inte
rnat
iona
lye
sye
sye
sye
sye
s-
yes
yes
yes
yes
-ye
sye
sye
sye
sye
s
17.U
seof
Nat
iona
lorO
ther
Seed
Cer
tific
atio
nSc
hem
esye
sye
sye
sye
sye
s-
yes
nono
yes
-ye
sye
sye
sno
yes
18.S
igna
tory
toU
POV
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
-ye
sye
sye
sye
sye
s
-
33
**T
AB
LE
1.O
VE
RV
IEW
OF
RE
GU
LA
TO
RY
OV
ER
SIG
HT
SY
ST
EM
S
ARCH
CZHU
MO
SLSA
Gen
eral
Appr
oach
1.G
ener
alR
egul
ator
yO
vers
ight
Syst
em5
54
--
2(e)
5
2.N
atio
nalE
xper
tCom
mitt
eeye
sye
sye
s-
-no
yes
3.C
o-or
dina
tion
ofAg
ricul
tura
lBio
tech
nolo
gyAc
tiviti
esye
s(a)
yes(
d)ye
s-
-no
no
Envi
ronm
enta
lBio
safe
ty
4.R
egul
ator
yO
vers
ight
forR
esea
rch
and
Dev
elop
men
tye
sye
sye
s-
-no
yes
5.R
egul
ator
yO
vers
ight
forS
cale
-up
yes
yes
yes
--
noye
s
6.R
egul
ator
yO
vers
ight
forC
omm
erci
alis
atio
nno
yes
yes
--
noye
s
7.Si
mpl
ified
Proc
edur
esfo
rOve
rsig
htof
Fiel
dTe
stin
gye
sye
sno
--
nono
8.Be
nefit
sAn
alys
isye
sye
sye
s-
-no
yes
Food
Safe
ty
9.R
egul
ator
yO
vers
ight
forF
ood
4-
33
--
3
10.R
egul
ator
yO
vers
ight
forF
eed
4-
33
--
3
11.R
egul
atio
nfo
rCom
posi
tion
and
Nut
ritio
nalV
alue
ofC
onve
ntio
nalP
rodu
cts
yes
-ye
sye
s-
-no
12.U
seof
"Sub
stan
tialE
quiv
alen
ce"
--
yes
yes
--
-
13.U
seof
Bene
fits
Anal
ysis
--
yes
yes
--
-
CODE
S:
1.no
over
sigh
tsys
tem
2.ov
ersi
ghts
yste
mcu
rrent
lyun
derd
evel
opm
ent
3.sa
me
over
sigh
tsys
tem
asfo
rcon
vent
iona
lpro
duct
s4.
sam
eov
ersi
ghts
yste
mas
forc
onve
ntio
nalp
rodu
cts,
butm
odifi
edfo
rbio
tech
nolo
gypr
oduc
ts5.
spec
ific
over
sigh
tsys
tem
forb
iote
chno
logy
prod
ucts
-
34
**T
AB
LE
1.O
VE
RV
IEW
OF
RE
GU
LA
TO
RY
OV
ER
SIG
HT
SY
ST
EM
S(c
on
tin
ued
)
ARCH
CZHU
MO
SLSA
Varie
talR
egis
tratio
nan
dSe
edCe
rtific
atio
n
14.V
arie
talR
egis
tratio
nye
s(b)
yes
yes
yes
yes
yes
yes
15.R
equi
rem
entt
hatV
arie
ties
BeSo
ldas
Cer
tifie
dSe
edye
sno
yes
yes
yes
yes
yes
16.U
seof
OEC
DSe
edC
ertif
icat
ion
Sche
mes
Dom
estic
yes
noye
sye
sno
noye
s
Inte
rnat
iona
lye
sye
sye
sye
sye
sye
sye
s
17.U
seof
Nat
iona
lSee
dC
ertif
icat
ion
Sche
mes
yes
yes
-ye
sye
sye
sye
s
18.S
igna
tory
toU
POV
no(c
)-
yes
yes
noye
sye
s
-
FOOTNOTES
TABLE 1. OVERVIEW OF REGULATORY OVERSIGHT SYSTEMS
a. The current system for oversight is a review by the Genetic Manipulation AdvisoryCommittee, which is non-statutory. A statutory system is currently under development.
b. A Commonwealth-States governmental committee: Standing Committee on Agricultureand Resource Management.
c. A draft law on genetic engineering, the "Gene Law" (covering contained use, deliberaterelease, genome analysis, human gene therapy), which passed the Austrian Council ofMinisters in January 1994 (and is now being dealt with by Parliament), may come intoforce in January 1995. This provision will come into effect once the law is in force.
d. In development.
e. Data requirements procedure. It will provide multi-site and multi-year authorisations.
f. "Federal Regulatory Framework for Biotechnology". This is augmented by numerous"memoranda of understanding" that outline various federal agencies’ roles, responsibilitiesand working relationships.
g. Developed notification system for repeating identical trials with identical protocols usingthe same form.
h. "Genetic Engineering Law" and six Directives.
i. Interministerial Commission.
j. Oversight system is established by the Guideline and rDNA Application SpecialCommittee of MAFF.
k. In the Ministry for Agriculture, Fisheries and Forestry, the biotechnology division plays animportant role in co-ordinating the various agricultural biotechnology activities.
l. Reduced information requirements and simpler or no administrative procedures.
m. Environmental releases of genetically modified plants are covered by the Plant ProtectionAct. A new, more complete oversight system is currently under development.
n. In preparation.
o. A specific oversight system for biotechnology products is currently in preparation.
p. The oversight system foreseen for modern biotechnology in Switzerland is described inthe report, IDAGEN.
35
-
q. The Swiss interdisciplinary Committee for Biosafety in Research and Technology does nothave any legal status yet. This Committee, put in place by the Swiss Academies ofScience, has developed its own guidelines for the release of GMOs into the environment.These guidelines are based on the OECD recommendations and EU Directive 90/220.
r. It applies only to some products. The principal aim of the laws in the field of foodstuffsis protection of consumers from health hazards and misleading information.
s. The Secretary of State for the Environment acts with the Minister of Agriculture, Fisheriesand Food on matters in which the Minister is concerned, as provided for at Part VI of theEnvironmental Protection Act 1990.
t. Domestic administrative procedure for a certain crop trait combination, based onexperience.
u. A formal voluntary clearance scheme with published guidelines, run by the AdvisoryCommittee on Novel Foods and Processes, exists for the clearance of novel foodsincluding those foods containing or consisting of genetically modified organisms.
v. Benefits would be apparent from the data generated for the safety assessment. This datais required for all novel foods, not solely for those derived from modern biotechnology,and includes, for example, details of nutritional and toxicological studies.
w. The US oversight system is product and end user specific and utilizes existing legislationand legal authorities for regulation. Products are regulated on a case-by-case basis, andthe approach is based on the principle that the risks inherent in biotechnology derivedproducts are the same in kind as those of products developed through traditional means.
x. Regulatory authority and interagency co-ordination was set out in the "Co-ordinatedFramework for the Regulation of the Products of Biotechnology" in 1986. Mostinterdepartmental co-ordination is done by individual staff-to-staff liaison. Interagency co-ordination within the USDA is accomplished through the forum of the BiotechnologyCouncil, on which are representatives of all USDA agencies with an interest inbiotechnology.
y. USDA regulations are not scale-dependent, so for USDA these categories are notdistinguished. Under EPA draft regulations for plant-pesticides, an experimental usepermit from EPA may be required for large-scale field trials.
z. There are no government regulations specific for commercialisation of most plants per se.However, for many transgenic plants it may be desirable that prior to commercialisationa determination be made, by USDA APHIS, that the plants had no potential to pose aplant pest risk. In addition, under draft regulations, plant pesticides require registrationsby EPA for commercial use, and FDA food safety requirements need to be addressed forany product sold as food.
aa. A notification system has been adopted by USDA enabling an applicant to certify, forcertain types of crops and certain types of modifications, that the tests are beingconducted in conformance with performance standards that will prevent persistence of thetest plants or their progeny in the environment.
36
-
bb. No benefit analysis performed by USDA in a review; however, benefit analysis isperformed by EPA for review of plant-pesticides.
cc. FDA and USDA had a number of regulations relating to the labelling of conventional foodproducts.
dd. On a conceptual basis, but the term has no legal standing.
ee. However, there is voluntary participation in a variety registry to protect a variety under thePlant Variety Protection Act (7 U.S.C. 2329) and the Plant Patent Act (U.S.C., Title 35,Section 161).
** TABLE 1. OVERVIEW OF REGULATORY OVERSIGHT SYSTEMS
a. National Agriculture Biotechnology Commission, where all the sectors related arerepresented.
b. Seed Law No. 20 247 allows property rights on new varieties.
c. The law to sign the UPOV convention is going through Parliament.
d. Through a national expert committee formed by ministries, universities, and the officialresearch institute.
e. Oversight is under development. Specialists who will work in this area will be delegatedfrom control, testing and scientific institutes of the Slovak Republic.
37
-
38
-
Annex II:
Environmental Biosafety
Part AData Elements Used in Environmental
Biosafety Reviews
39
-
40
-
41
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2a.
Ch
arac
teri
stic
so
fD
on
or
Org
anis
ms
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Taxo
nom
y,id
entif
icat
ion,
sour
ce,c
ultu
re
Nam
esan
dde
sign
atio
ns(a
)(b
)(c
)
Deg
ree
ofre
late
dnes
sbe
twee
nth
edo
noro
rgan
ism
and
reci
pien
tpla
nt,a
ndev
iden
cein
dica
ting
exch
ange
ofge
netic
mat
eria
lby
natu
ralm
eans
Cha
ract
eris
tics
ofth
eor
gani
smw
hich
perm
itid
entif
icat
ion
and
the
met
hods
used
toid
entif
yth
eor
gani
sms
Tech
niqu
esem
ploy
edin
the
labo
rato
ryan
d/or
envi
ronm
ent
ford
etec
ting
the
pres
ence
of,a
ndfo
rmon
itorin
g,nu
mbe
rsof
the
orga
nism
Sour
ces
ofth
eor
gani
sms
Oth
er:
Trai
tint
ende
dfo
rtra
nsm
ittan
ce
Gen
etic
char
acte
ristic
sof
dono
rorg
anis
ms
His
tory
ofpr
iorg
enet
icm
anip
ulat
ion
Cha
ract
eris
atio
nof
the
dono
rgen
omes
Path
ogen
ican
dph
ysio
logi
calt
raits
ofdo
noro
rgan
ism
s
Nat
ure
ofpa
thog
enic
ityan
dvi
rule
nce,
infe
ctiv
ityor
toxi
geni
city
Hos
tran
ge
Oth
erpo
tent
ially
sign
ifica
ntph
ysio
logi
calt
raits
Stab
ility
ofth
ese
traits
-
42
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2b.
Ch
arac
teri
stic
so
fR
ecip
ien
tP
lan
ts
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Taxo
nom
y,id
entif
icat
ion,
sour
ce,c
ultu
re
Nam
esan
dde
sign
atio
ns
Deg
ree
ofre
late
dnes
sbe
twee
nth
edo
noro
rgan
ism
and
reci
pien
tpla
nt,
and
evid
ence
indi
catin
gex
chan
geof
gene
ticm
ater
ialb
yna
tura
lmea
ns
Cha
ract
eris
tics
ofth
epl
antw
hich
perm
itid
entif
icat
ion
and
the
met
hods
used
toid
entif
yth
epl
ant
Tech
niqu
esem
ploy
edin
the
labo
rato
ryan
d/or
envi
ronm
entf
orde
tect
ing
the
pres
ence
of,a
ndfo
rmon
itorin
g,nu
mbe
rsof
the
plan
t
Sour
ces
ofth
epl
ants
Info
rmat
ion
onth
ere
cipi
entp
lant
’sre
prod
uctiv
ecy
cle
(sex
ual/a
sexu
al)
Fact
ors
whi
chm
ight
limit
the
repr
oduc
tion,
grow
than
dsu
rviv
alof
the
reci
pien
tpla
nt
Oth
er:
Whe
ther
reci
pien
tpla
ntis
exot
ican
dits
dist
ribut
ion
His
tory
ofcu
ltiva
tion
and
safe
use
Gen
etic
char
acte
ristic
sof
reci
pien
tpla
nts
His
tory
ofpr
iorg
enet
icm
anip
ulat
ion
Cha
ract
eris
atio
nof
the
reci
pien
t
Stab
ility
ofre
cipi
entp
lant
inte
rms
ofre
leva
ntge
netic
traits
Oth
er:
Path
ogen
ican
dph
ysio
logi
calt
raits
ofre
cipi
entp
lant
s
Nat
ure
ofpa
thog
enic
ityan
dvi
rule
nce,
infe
ctiv
ityor
toxi
geni
city
p
Hos
tran
ge
Oth
erpo
tent
ially
sign
ifica
ntph
ysio
logi
calt
raits
Stab
ility
ofth
ese
traits
Oth
er:
Rel
ated
ness
ofre
cipi
entt
opl
ants
know
nto
bew
eeds
Pote
ntia
lfor
cros
s-po
llinat
ion
with
wild
rela
tives
-
43
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2c.
Ch
arac
ter
of
the
Mo
dif
ied
Pla
nt
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Des
crip
tion
ofth
em
odifi
catio
n
Des
crip
tion
ofth
ena
ture
,fun
ctio
nan
dso
urce
ofth
ein
serte
ddo
norn
ucle
icac
id,i
nclu
ding
regu
lato
ryor
othe
rele
men
tsaf
fect
ing
the
func
tion
ofth
eD
NA
and
ofth
eve
ctor
Des
crip
tion
ofth
em
etho
d(s)
byw
hich
the
vect
orw
ithin
sert(
s)ha
sbe
enco
nstru
cted
Des
crip
tion
ofm
etho
dsfo
rint
rodu
cing
the
vect
or-in
sert
into
the
reci
pien
tpla
ntan
dth
epr
oced
ure
fors
elec
tion
ofth
em
odifi
edpl
ant
Des
crip
tion
ofth
est
ruct
ure
and
amou
ntof
any
vect
oran
d/or
dono
rnuc
leic
acid
rem
aini
ngin
the
final
cons
truct
ion
ofth
em
odifi
edpl
ant
Cha
ract
eris
atio
nof
the
site
ofm
odifi
catio
nof
the
reci
pien
tgen
ome.
Stab
ility
ofth
ein
serte
dD
NA
pp
pp
Freq
uenc
yof
mob
ilisat
ion
ofin
serte
dse
quen
cean
d/or
gene
tictra
nsfe
rcap
abilit
y
Rat
ean
dle
velo
fexp
ress
ion
ofth
ein
trodu
ced
gene
ticm
ater
ial.
Met
hod
and
sens
itivi
tyof
mea
sure
men
t
Influ
ence
ofth
ere
cipi
entp
lant
onth
eac
tivity
ofth
efo
reig
npr
otei
n
Deg
ree
ofsi
mila
rity
betw
een
type
ofge
netic
mod
ifica
tion
and
thos
eac
hiev
edus
ing
plan
tbre
edin
gor
othe
rcon
vent
iona
lmet
hods
ofge
netic
mod
ifica
tion
Oth
er:
Mar
kers
that
will
enab
leth
em
odifi
edpl
antt
obe
iden
tifie
d
Gen
etic
feat
ures
that
limit
the
mod
ified
plan
t’sab
ility
tore
prod
uce
ortra
nsfe
rit
Phen
otyp
eof
the
mod
ified
plan
tcom
pare
dto
the
unm
odifi
edon
e
-
44
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2d.
Hu
man
Hea
lth
Co
nsi
der
atio
ns
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Char
acte
ristic
sof
the
Mod
ified
Plan
t
Com
paris
onof
the
mod
ified
plan
tto
the
reci
pien
tpla
ntre
gard
ing
path
ogen
icity
Cap
acity
forc
olon
isat
ion
Oth
er:
Com
paris
onof
mod
ified
plan
tto
reci
pien
treg
ardi
ngto
xici
ty
Nat
ural
lyoc
curri
ngto
xica
nts
and
anti-
nutri
ents
Heal
thCo
nsid
erat
ions
Gen
eral
lyAs
soci
ated
with
the
Pres
ence
ofNo
n-vi
able
Plan
tsor
with
the
Prod
ucts
ofRD
NApr
oces
ses
Toxi
cor
alle
rgen
icef
fect
sof
non-
viab
lepl
ants
and/
orth
eirm
etab
olic
prod
ucts
Prod
ucth
azar
ds
Oth
er:
Seco
ndar
yef
fect
s
Man
agem
ento
fPer
sonn
elEx
posu
re
Biol
ogic
alm
easu
res
*
Avai
labi
lity
ofap
prop
riate
prop
hyla
xis
and
ther
apie
s*
Avai
labi
lity
ofm
edic
alsu
rvei
llanc
e*
Phys
ical
and
orga
niza
tiona
lmea
sure
s
Oth
er:
Prop
erm
anag
emen
t,tra
inin
g
Expo
sure
toal
lerg
ens,
toxi
ns
Avai
labi
lity
ofap
prop
riate
prot
ectiv
ecl
othi
ng
-
45
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2e.
En
viro
nm
enta
lan
dA
gro
no
mic
Co
nsi
der
atio
ns
(Par
t1
of
4)
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Ecol
ogic
alTr
aits
Rela
ting
toth
eDo
nora
ndRe
cipi
ent
Nat
ural
habi
tata
ndge
ogra
phic
dist
ribut
ion;
clim
atic
char
acte
ristic
sof
orig
inal
habi
tats
Sign
ifica
ntin
volv
emen
tin
envi
ronm
enta
lpro
cess
Path
ogen
icity
–ho
stra
nge,
infe
ctiv
ity,t
oxig
enic
ity,v
irule
nce,
vect
ors
p
Inte
ract
ions
with
and
effe
cts
onot
hero
rgan
ism
sin
the
envi
ronm
ent
Abilit
yto
form
surv
ival
stru
ctur
e(e
.g.s
eeds
,spo
res,
scle
rotia
)
Freq
uenc
yof
geno
typi
can
dph
enot
ypic
chan
ge
Rol
eof
gene
ticm
ater
ialt
obe
dona
ted
onth
eec
olog
yof
the
dono
ror
gani
sm
Pred
icte
def
fect
sof
the
dona
ted
gene
ticm
ater
ialo
nth
ere
cipi
entp
lant
Appl
icat
ion
ofth
eM
odifi
edPl
anti
nth
eEn
viro
nmen
t
Geo
grap
hica
lloc
atio
nsi
te,p
hysi
cala
ndbi
olog
ical
prox
imity
tom
anan
d/or
any
othe
rsig
nific
antb
iota
Des
crip
tion
ofsi
tein
clud
ing
size
and
prep
arat
ion,
clim
ate,
tem
pera
ture
,re
lativ
ehu
mid
ity,e
tc.
Con
tain
men
tand
deco
ntam
inat
ion
Intro
duct
ion
prot
ocol
sin
clud
ing
quan
tity
and
frequ
ency
ofap
plic
atio
n
Met
hods
ofsi
tedi
stur
banc
eor
culti
vatio
np
Met
hods
form
onito
ring
appl
icat
ions
Con
tinge
ncy
plan
s
Trea
tmen
tpro
cedu
reof
site
atth
eco
mpl
etio
nof
appl
icat
ion
Oth
er:
Tran
spor
tarra
ngem
ents
Post
-rele
ase
mon
itorin
gof
the
site
Impa
ctof
plan
t
-
46
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2e.
En
viro
nm
enta
lan
dA
gro
no
mic
Co
nsi
der
atio
ns
(Par
t2
of
4)
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Surv
ival
,Mul
tiplic
atio
nan
dDi
ssem
inat
ion
ofth
eM
odifi
edPl
anti
nth
eEn
viro
nmen
t
Dete
ctio
n,id
entif
icat
ion
and
mon
itorin
gte
chni
ques
Des
crip
tion
ofde
tect
ion,
iden
tific
atio
nan
dm
onito
ring
tech
niqu
es
Spec
ifici
ty,s
ensi
tivity
and
relia
bilit
yof
dete
ctio
nte
chni
ques
Tech
niqu
esfo
rdet
ectin
gtra
nsfe
roft
hedo
nate
dD
NA
toot
her
orga
nism
s
Char
acte
ristic
saf
fect
ing
surv
ival
,mul
tiplic
atio
nan
ddi
ssem
inat
ion
Biol
ogic
alfe
atur
esw
hich
affe
ctsu
rviv
al,m
ultip
licat
ion
ordi
ssem
inat
ion
Beha
viou
rin
sim
ulat
edna
tura
lenv
ironm
ents
such
asm
icro
cosm
s,gr
owth
room
s,gr
eenh
ouse
s,et
c.*
Know
nan
dpr
edic
ted
envi
ronm
enta
lcon
ditio
nsw
hich
may
affe
ctsu
rviv
al,m
ultip
licat
ion
and
diss
emin
atio
n
Oth
er:
Poss
ible
com
petit
ive
adva
ntag
eof
the
mod
ified
plan
t
Met
hods
tom
inim
ise
diss
emin
atio
nof
the
mod
ified
plan
tort
rait
-
47
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2e.
En
viro
nm
enta
lan
dA
gro
no
mic
Co
nsi
der
atio
ns
(Par
t3
of
4)
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Inte
ract
ions
ofM
odifi
edPl
ant(s
)with
Biol
ogic
alSy
stem
s
Targ
etan
dno
n-ta
rget
popu
latio
ns
Know
nan
dpr
edic
ted
habi
tats
ofth
em
odifi
edpl
ant
Des
crip
tion
ofth
eta
rget
ecos
yste
ms
and
ofec
osys
tem
sto
whi
chth
epl
ant
coul
dbe
diss
emin
ated
Iden
tific
atio
nan
dde
scrip
tion
ofta
rget
orga
nism
s
Antic
ipat
edm
echa
nism
and
resu
ltof
inte
ract
ion
betw
een
the
mod
ified
plan
tan
dth
eta
rget
orga
nism
(s)
Iden
tific
atio
nan
dde
scrip
tion
ofno
n-ta
rget
orga
nism
(s)w
hich
mig
htbe
expo
sed
Stab
ility
Stab
ility
ofth
epl
anti
nte
rms
ofge
netic
traits
Gen
etic
trans
ferc
apab
ility
Like
lihoo
dof
post
-rele
ase
sele
ctio
nle
adin
gto
the
expr
essi
onof
unex
pect
edan
dun
desi
rabl
etra
itsby
the
mod
ified
plan
t
Mea
sure
sem
ploy
edto
ensu
rege
netic
stab
ility,
ifan
y
Des
crip
tion
ofge
netic
traits
that
prev
ent/m
inim
ise
disp
ersa
lofg
enet
icm
ater
ial
Rout
esof
diss
emin
atio
n
Rou
tes
ofdi
ssem
inat
ion,
phys
ical
orbi
olog
ical
Know
nor
pote
ntia
lmod
esof
inte
ract
ion,
incl
udin
gin
hala
tion,
inge
stio
n,su
rface
cont
act,
burro
win
gan
din
ject
ion
-
48
TA
BL
E2.
DA
TA
EL
EM
EN
TS
US
ED
INE
NV
IRO
NM
EN
TA
LB
IOS
AF
ET
YR
EV
IEW
S
2e.
En
viro
nm
enta
lan
dA
gro
no
mic
Co
nsi
der
atio
ns
(Par
t4
of
4)
ASAU
BECA
DEFR
GE
ITJA
NENZ
NOSW
ESW
IUK
US
Pote
ntia
lEnv
ironm
enta
lIm
pact
s
Pote
ntia
leffe
cts
onta
rget
and
non-
targ
etor
gani
sms
Path
ogen
icity
,inf
ectiv
ity,t
oxig
enic
ity,v
irule
nce,
vect
orof
path
ogen
,alle
rgen
icity
,col
onis
atio
np
p
Know
nor
pred
icte
def
fect
son
othe
rorg
anis
ms
inth
een
viro
nmen
t
Like
lihoo
dof
post
-rele
ase
shift
sin
biol
ogic
alin
tera
ctio
nsor
inho
stra
nge
Oth
er:
Effe
cts
onot
hers
peci
esan
dpo
ssib
ility
oftra
nsfe
rofi
ntro
duce
dtra
itto
othe
rspe
cies
Effe
cton
plan
t’sco
mpe
titiv
ead
vant
ages
Effe
cton
plan
t’sbi
odeg
rada
bilit
y
Any
othe
rpos
sibl
eec
olog
ical
effe
cts
Ecos
yste
ms
effe
cts
Know
nor
pred
icte
din
volv
emen
tin
biog
eoch
emic
alpr
oces
ses
Pote
ntia
lfor
exce
ssiv
epo
pula
tion
incr
ease
-
49
**T
AB
LE
2.D
AT
AE
LE
ME
NT
SU
SE
DIN
EN
VIR
ON
ME
NT
AL
BIO
SA
FE
TY
RE
VIE
WS
2a.
Ch
arac
teri
stic
so
fD
on
or
Org
anis
ms AR
CHCZ
HUM
OSL
SA
Taxo
nom
y,id
entif
icat
ion,
sour
ce,c
ultu
re
Nam
esan
dde
sign
atio
ns—
——
Deg
ree
ofre
late
dnes
sbe
twee
nth
edo
noro
rgan
ism
and
reci
pien
tpla
nt,a
ndev
iden
cein
dica
ting
exch
ange
ofge
netic
mat
eria
lby
natu
ralm
eans
——
—
Cha
ract
eris
tics
ofth
eor
gani
smw
hich
perm
itid
entif
icat
ion
and
the
met
hods
used
toid
entif
yth
eor
gani
sms
——
—
Tech
niqu
esem
ploy
edin
the
labo
rato
ryan
d/or
envi
ronm
entf
orde
tect
ing
the
pres
ence
of,a
ndfo
rmon
itorin
g,nu
mbe
rsof
the
orga
nism
——
—
Sour
ces
ofth
eor
gani
sms
——
—
Gen
etic
char
acte
ristic
sof
dono
rorg
anis
ms
His
tory
ofpr
iorg
enet
icm
anip
ulat
ion
——
—
Cha
ract
eris
atio
nof
the
reci
pien
tand
dono
rgen
omes
——
—
Path
ogen
ican
dph
ysio
logi
calt
raits
ofdo
noro
rgan
ism
s
Nat
ure
ofpa
thog
enic
ityan
dvi
rule
nce,
infe
ctiv
ityor
toxi
geni
city
——
—
Hos
tran
ge—
——
Oth
erpo
tent
ially
sign
ifica
ntph
ysio
logi
calt
raits
——
—
Stab
ility
ofth
ese
traits
-
50
**T
AB
LE
2.D
AT
AE
LE
ME
NT
SU
SE
DIN
EN
VIR
ON
ME
NT
AL
BIO
SA
FE
TY
RE
VIE
WS
2b.
Ch
arac
teri
stic
so
fR
ecip
ien
tP
lan
ts AR
CHCZ
HUM
OSL
SA
Taxo
nom
y,id
entif
icat
ion,
sour
ce,c
ultu
re
Nam
esan
dde
sign
atio
ns—
——
Deg
ree
ofre
late
dnes
sbe
twee
nth
edo
noro
rgan
ism
and
reci
pien
tpla
ntan
dev
iden
cein
dica
ting
exch
ange
ofge
netic
mat
eria
lby
natu
ralm
eans
——
—
Cha
ract
eris
tics
ofth
epl
antw
hich
perm
itid
entif
icat
ion
and
the
met
hods
used
toid
entif
yth
epl
ant
——
—
Tech
niqu
esem
ploy
edin
the
labo
rato
ryan
d/or
envi
ronm
entf
orde
tect
ing
the
pres
ence
of,a
ndfo
rmon
itorin
g,nu
mbe
rsof
the
plan
t—
——
Sour
ces
ofth
epl
ants
——
—
Info
rmat
ion
onth
ere
cipi
entp
lant
’sre
prod
uctiv
ecy
cle
(sex
ual/a
sexu
al)
——
—
Fact
ors
whi
chm
ight
limit
the
repr
oduc
tion,
grow
than
dsu
rviv
alof
the
reci
pien
tpla
nt—
——
Gen
etic
char
acte
ristic
sof
reci
pien
tpla
nts
His
tory
ofpr
iorg
enet
icm
anip
ulat
ion
——
—
Cha
ract
eris
atio
nof
the
reci
pien
tand
dono
rgen
omes
——
—
Stab
ility
ofre
cipi
entp
lant
inte
rms
ofre
leva
ntge
netic
traits
——
—
Path
ogen
ican
dph
ysio
logi
calt
raits
ofre
cipi
entp
lant
s
Nat
ure
ofpa
thog
enic
ityan
dvi
rule
nce,
infe
ctiv
ity,o
rtox
igen
icity
——
—
Hos
tran
ge—
——
Oth
erpo
tent
ially
sign
ifica
ntph
ysio
logi
calt
raits
——
—
Stab
ility
ofth
ese
traits
——
—
-
51
**T
AB
LE
2.D
AT
AE
LE
ME
NT
SU
SE
DIN
EN
VIR
ON
ME
NT
AL
BIO
SA
FE
TY
RE
VIE
WS
2c.
Ch
arac
ter
of
the
Mo
dif
ied
Pla
nt
ARCH
CZHU
MO
SLSA
Des
crip
tion
ofth
em
odifi
catio
n—
——
Des
crip
tion
ofth
ena
ture
,fun
ctio
nan
dso
urce
ofth
ein
serte
ddo
norn
ucle
icac
id,i
nclu
ding
regu
lato
ryor
othe
rel
emen
tsaf
fect
ing
the
func
tion
ofth
eD
NA
and
ofth
eve
ctor
——
—
Des
crip
tion
ofth
em
etho
d(s)
byw
hich
the
vect
orw
ithin
sert(
s)ha
sbe
enco
nstru
cted
——
—
Des
crip
tion
ofm
etho
dsfo
rint
rodu
cing
the
vect
or-in
sert
into
the
reci