CropLife CropLife International Compliance International Compliance - - PowerPoint PPT Presentation

Representing the Plant Science Industry

Field Trials of Experimental, Field Trials of Experimental, Genetically Engineered Plants Genetically Engineered Plants

CropLife CropLife International Compliance International Compliance Management Programme Management Programme for Confined for Confined Field Trials Field Trials

Issues that we are NOT dealing with during Issues that we are NOT dealing with during this workshop this workshop

Globalization Risks Benefits Grower Satisfaction Public Trust Regulatory Oversight Labelling Testing and Traceability Commodity Markets Segregation Identity Preservation Openness and Transparency Risk Communication Social Acceptability Confined Trials

· For 2004, it is estima For 2004, it is estimated that ted that total acreage 200 million – total acreage 200 million – a 20% increase over 2003 20% increase over 2003 · More than 8.25 millio More than 8.25 million n farmers are growing farmers are growing transgenic crops, 90% of transgenic crops, 90% of these are resource-poor these are resource-poor farmers in developing farmers in developing countries untries · The percentage growth in The percentage growth in area between 2003 and area between 2003 and 2004 in developing 2004 in developing countries (35%) was almost countries (35%) was almost 3X grea 3X greater than for ter than for industrialized countries industrialized countries (13%) (13%)

Continued growth in GM crop area Continued growth in GM crop area

Global Area of Transgenic Crops (Source: Clive James, 2004)

20 40 60 80 100 120 140 160 1996 1997 1998 1999 2000 2001 2002 2003 2004

Year Acres (million)

Industrial Developing

Distribution of GM crops by country Distribution of GM crops by country

· In 2004, six countries In 2004, six countries grew 98% of the global grew 98% of the global GM crop area GM crop area

– USA – USA – 59% 59% – Argentina – Argentina – 20% 20% – Canada – Canada – 6% – Brazil – Brazil – 6% – China – China – 5% – Paraguay – Paraguay – 2%

20 40 60 80 100 120

Acres (millions)

1996 1998 2000 2002 2004

Year

Acreage of Transgenic Crops by Country

(Source: Clive James, 2004) USA Argentina Canada China

· Nearly all of the area Nearly all of the area plant planted to transgenic d to transgenic crops is accounted for crops is accounted for by four crops, which in by four crops, which in 2004 were represented 2004 were represented by: by: – Soybean – Soybean – 60% 60% – Maize – Maize – 23% 3% – Cotton – Cotton – 11% 1% – Canola – Canola – 6%

Distribution of GM crops by crop Distribution of GM crops by crop

20 40 60 80 100 120 140

Acres (millions)

1996 1997 1998 1999 2000 2001 2002 2003 2004

Year

Global Acreage by Crop (Source: Clive James, 2004)

Soybean Maize Cotton Canola

· Of the global aggregate Of the global aggregate area of these 4 crops area of these 4 crops (710 M acres) in 2004, (710 M acres) in 2004, 29% was planted to 29% was planted to biotech varieties. biotech varieties. · In 2004, the global In 2004, the global market value of biotech market value of biotech crops was e crops was estim timated at d at $4.7 $4.7 billion, re billion, representing presenting 16% of the $30 16% of the $30 billion billion global global commercial seed commercial seed market market

Global adoption of GM soy, cotton, canola & Global adoption of GM soy, cotton, canola & maize maize

Global Area Adoption Rates by Crop

(Source: Clive James, 2004) 50 100 150 200 250 300 350 400 Soybean Cotton Canola Maize

Crop Acres (millions)

Transgenic Total

· Broader applicati Broader application of n of plant biotechnol plant biotechnology

• gy

produ products ne ts needs a syste eds a system in place to permit the in place to permit the safe safe conduct of confined field conduct of confined field trials rials. · Capabilit Capability to safely y to safely pe perfo rform confined t m confined trials is rials is equally impo equally important in both rtant in both industrialized and industrialized and developing countries. developing countries. · A system must exist A system must exist whereby locally developed whereby locally developed and fo and foreign applications reign applications can be assessed and can be assessed and evaluated for potenti evaluated for potential al biosafety impacts. biosafety impacts.

Global snapshot: Africa Global snapshot: Africa

sugar cane

soya

Global snapshot: Asia Global snapshot: Asia

Global snapshot: Central & Eastern Europe Global snapshot: Central & Eastern Europe

I think we should change this to Europe including the new accession states

Global snapshot: Central & South America Global snapshot: Central & South America

Regulatory framework for confined field trials Regulatory framework for confined field trials in the Philippines in the Philippines

Roles CBI Timeframes

Terminology Terminology · Contained use (laboratory, Contained use (laboratory, greenhouse, screenhouse) greenhouse, screenhouse) · Confined environmental Confined environmental release (field test) release (field test) · Unconfined environmental Unconfined environmental release (commercialization) release (commercialization)

Experimental

Risk Mitigation Risk Assess.

What is a confined field trial? What is a confined field trial?

· A confined field trial is a A confined field trial is a small-scale experimental field trial of a genetically field trial of a genetically engineered plant species carried out engineered plant species carried out to to collect the data necessary for a necessary for a complete environmental risk complete environmental risk assessment that is performed under assessment that is performed under terms and conditions that terms and conditions that mitigate impacts on the surrounding

• n the surrounding

environment environment

Trials we are all familiar with Trials we are all familiar with · Breeders’ trials (experimental) Breeders’ trials (experimental)

– Agronomic evaluation of new crosses Agronomic evaluation of new crosses – Evaluation of new germplasm, perhaps Evaluation of new germplasm, perhaps imported from elsewhere imported from elsewhere

· Variety registration trials Variety registration trials

– Performance trials, demonstration of merit Performance trials, demonstration of merit (value) (value)

· Plant breeders’ rights trials Plant breeders’ rights trials

– DUS – DUS – demonstration of distinctness, emonstration of distinctness, uniformity, and stability uniformity, and stability

Purpose of confined field trials Purpose of confined field trials

· For the breeder – For the breeder – to collect agronomic performance

• collect agronomic performance

data (efficacy of the modification, yield, etc), same data (efficacy of the modification, yield, etc), same as for a conventional trial as for a conventional trial · To collect data to complete the environmental risk To collect data to complete the environmental risk assessment assessment

– Secondary effects on non-target organisms Secondary effects on non-target organisms – Morphological characterization – Morphological characterization – seed dissemination, eed dissemination, do dormancy of seed, ge rmancy of seed, germination rate rmination rate, time , time to maturit to maturity, y, disease and pest resistance disease and pest resistance

· To generate data for variety registration To generate data for variety registration

Purpose of confined field trials (cont’d) Purpose of confined field trials (cont’d)

· To produce material for livestock feed performance To produce material for livestock feed performance trials trials · To produce material for food safety evaluations (raw To produce material for food safety evaluations (raw seed/grain and derived fractions) seed/grain and derived fractions)

– Nut Nutritional compositional an ritional compositional analysis (proximates, amino alysis (proximates, amino acids, fatty acids, minerals, vitamins, etc) acids, fatty acids, minerals, vitamins, etc) – Levels of endogenous anti Levels of endogenous antinutrients, toxicants, and nutrients, toxicants, and allergens allergens

· Data are usually collected from trials in multiple Data are usually collected from trials in multiple locations, representing a range of growing locations, representing a range of growing conditions, and over multiple years conditions, and over multiple years

Confined field t Confined field trials ials

Most lines in confined field trials do Most lines in confined field trials do NOT end up as products end up as products

Contained Laboratory Experimentation Confined Field Trial Experimentation 100’s – 1000’s Potential Lines 10 - 100 Potential Lines 1 – 4 Lines Submitted for Unconfined Approval New trait moved into 10 – 100 varieties using Traditional breeding Post-approval Use of new line In breeding programs Application for Unconfined (commercial) Release Application for Confined Field Trial

Risk management approach Risk management approach

· The necessity of being able to The necessity of being able to safely safely evaluate plants of uncertain risk evaluate plants of uncertain risk cannot be cannot be

• ver emphasized.
• ver emphasized.

· A crucial distinction between A crucial distinction between unconfined unconfined environmental releases environmental releases and and confined trials confined trials that has not been sufficiently appreciated in that has not been sufficiently appreciated in some countries, either by regulators, some countries, either by regulators, national biosafety committees, or capacity national biosafety committees, or capacity builders and trainers. builders and trainers.

Risk management approach Risk management approach

· At the level of an At the level of an unconfined unconfined release, the release, the focus must be on focus must be on rigorous risk assessment rigorous risk assessment as the intent is widespread introduction of as the intent is widespread introduction of the modified plant into agriculture, usually the modified plant into agriculture, usually with few or no restrictions. with few or no restrictions. · Conversely, for Conversely, for confined confined trials the risks may trials the risks may not yet be fully understood without data not yet be fully understood without data collected during the trial, hence the focus collected during the trial, hence the focus must be on must be on risk management risk management – t – the t terms and conditions that are necessary to permit and conditions that are necessary to permit safe trial conduct. safe trial conduct.

Risk = Exposure x Hazard Risk = Exposure x Hazard

· The risk management The risk management approach recognizes approach recognizes that hazards may not that hazards may not fully understood for fully understood for field trials, so the field trials, so the focu focus is on s is on preventing exposure preventing exposure by implementing by implementing specific specific mitigation mitigation measures measures · Risk assessment is Risk assessment is about about hazard hazard identification a identification and d characterization, and characterization, and exposure exposure estimation estimation · Hazards can be: Hazards can be:

– Pro Probabilistic abilistic – Hypotheti Hypothetical cal – Speculative Speculative

“3-Ps” of risk management for field trials “3-Ps” of risk management for field trials

Aim to: Aim to: · Prevent Prevent dissemination dissemination of new genes in experimental

• f new genes in experimental

transgenic plant into and within the environment (ie transgenic plant into and within the environment (ie prevent pollen-mediated gene flow) prevent pollen-mediated gene flow) · Prevent Prevent the the persistence persistence in the environment of the in the environment of the experimental transgenic plant and any progeny experimental transgenic plant and any progeny plant plants · Prevent Prevent the the introduction introduction of the experimental

• f the experimental

transgenic plant (or products transgenic plant (or products) into the livestock feed ) into the livestock feed and human and human food pathways food pathways

Confined trial process Confined trial process

Application Permit Planting Harvest/Termination Completion Technical Review Regulatory Decision

Legal Authorization With Terms & Conditions

Regulatory Inspections Current Season Post-Harvest Period

Preventing dissemination of new genes Preventing dissemination of new genes · Impose conditions of reproductive isolation Impose conditions of reproductive isolation

• n all plants within the trial site
• n all plants within the trial site

· Practically, reproductive isolation = means Practically, reproductive isolation = means used to control the movement of pollen used to control the movement of pollen from the trial site from the trial site · Ensures that new genes are not introgressed Ensures that new genes are not introgressed into neighbouring into neighbouring plants of the same or a lants of the same or a sexually compatible species sexually compatible species

Purpose of reproductive isolation Purpose of reproductive isolation · Prevent Prevent dissemination of new genes in dissemination of new genes in experimental transgenic plant into and experimental transgenic plant into and within the environment – within the environment – prevent pollen- revent pollen- mediated gene flow and seed dispersal mediated gene flow and seed dispersal · Three main methods Three main methods

– Spatial isolation Spatial isolation – Physical isolation Physical isolation – Temporal isolation Temporal isolation

Grapes

Transgenic maize 40 foot Border 50 foot Fallow

Confined maize trials in the U.S. Cotton

Preventing persistence in environment Preventing persistence in environment · Imposing conditions of post-harvest land Imposing conditions of post-harvest land use restriction and post-harvest monitoring use restriction and post-harvest monitoring for volunteers for volunteers

– i.e. no planting of the same plant species i.e. no planting of the same plant species

· Period of post-harvest restriction Period of post-harvest restriction depends on the plant species depends on the plant species

– ie: seed dormancy characteristics ie: seed dormancy characteristics

· Volunteers, related species and weedy Volunteers, related species and weedy relatives (where applicable) must be relatives (where applicable) must be removed from the post-harvest site before removed from the post-harvest site before flowering flowering

Preventing introduction into food/feed chain Preventing introduction into food/feed chain

Controlling the Controlling the · movement movement of plant material onto and off of the trial

• f plant material onto and off of the trial

site (transport and cleaning of any machinery used) site (transport and cleaning of any machinery used) · storage storage of plant material

• f plant material

· disposal disposal of residual or excess plant material on the

• f residual or excess plant material on the

trial site – trial site – excess planting materials, material xcess planting materials, material remaining after harvest, material from roguing, remaining after harvest, material from roguing, detasseling detasseling or deflowering activities r deflowering activities · disposition disposition of any material retained after harvest

• f any material retained after harvest

Terms & conditions + inspection & Terms & conditions + inspection & enforcement enforcement · The questions asked in applications for a The questions asked in applications for a confined field trial should relate directly to confined field trial should relate directly to confinement issues confinement issues · All of the provisions under the “3-Ps” All of the provisions under the “3-Ps” should be reflected in the should be reflected in the terms and terms and conditions of authorization conditions of authorization of a confined

• f a confined

field trial field trial · Adherence to the terms and conditions must Adherence to the terms and conditions must be be verified through inspection verified through inspection / auditing by / auditing by the regulatory authority the regulatory authority

Safety record Safety record

· The The combination combination of science-based risk management

• f science-based risk management

T&Cs T&Cs plus adequate inspection will contribute to the plus adequate inspection will contribute to the safe conduct of confined field trials safe conduct of confined field trials · Over the last 17 years (since 1987), more than Over the last 17 years (since 1987), more than 15,000 field trials have been conducted in 15,000 field trials have been conducted in numerous countries around the world numerous countries around the world · There is not a single docu There is not a single documented example of actual mented example of actual “harm” to the environment or to people or animals “harm” to the environment or to people or animals

Contingency planning Contingency planning · Applicants should be asked to provide Applicants should be asked to provide contingency plans for responding to contingency plans for responding to accidental breaches of confinement accidental breaches of confinement · Key elements should include Key elements should include

– The procedure for notifying the regulatory The procedure for notifying the regulatory authority authority – Measures for destroying the transgenic plant Measures for destroying the transgenic plant – Supervision and safety procedures Supervision and safety procedures – Communication strategy Communication strategy – Diagnostic methods to trace back if Diagnostic methods to trace back if necessary necessary

Developing a regulatory system Developing a regulatory system

Considerations: Considerations:

· Stipulati Stipulating the permissible means of achieving g the permissible means of achieving reproductive isol reproductive isolati ation (crop by crop) n (crop by crop) · Defining schedules (interva Defining schedules (intervals) for current season and ls) for current season and post-harvest monitoring post-harvest monitoring · Defining periods of post-har Defining periods of post-harvest vest land use land use restriction restriction (crop by cro rop by crop) · De Defining reco fining record-keeping requirements – rd-keeping requirements – activit ctivity based y based · Levels o Levels of in inspection spection – – current urrent season season, post , post-harvest

• harvest

pe period, facilities riod, facilities

Common requirements of a regulatory system Common requirements of a regulatory system · Clarity Clarity · Transparency Transparency · Consistency Consistency · Workability and enforceability Workability and enforceability · Adaptability Adaptability

Clarity Clarity

· Unambiguous (ie: scope and objectives) Unambiguous (ie: scope and objectives) · Clear differentiation between Clear differentiation between different activities (ie: different activities (ie: contained use, confined trials, unconfined releases, contained use, confined trials, unconfined releases, commodity imports/exports) – commodity imports/exports) – different application ifferent application and review processes and review processes · Clear division of resp Clear division of responsibilities between

• nsibilities between

government ministries (ie: food/feed vs. government ministries (ie: food/feed vs. environment, etc) environment, etc) · Clear interrelation with other existing regulatory Clear interrelation with other existing regulatory systems (ie: seeds regulations, plant import and systems (ie: seeds regulations, plant import and quarantine, etc) quarantine, etc)

Transparency Transparency

· The The applications system for permit pplications system for permits and/or authorizations must s and/or authorizations must be cle be clearly commu rly communicat cated – When and where applicatio When and where applications are to be submitted ns are to be submitted – What is to be included in th What is to be included in the application (ie: information e application (ie: information requirements) requirements) – Time standards for review and reporting Time standards for review and reporting · How is How is science advice provi science advice provided and taken into acc ded and taken into account unt – External review, expert pa External review, expert panels, government sc nels, government science ience evaluators evaluators · Basis of regulatory Basis of regulatory decision-making decision-making – How are decisions made and by whom How are decisions made and by whom – Independence and impartiality Independence and impartiality · What information is to be di What information is to be disclosed to the public and when sclosed to the public and when · Treatment of confidential Treatment of confidential business information business information

Workability Workability

· System must be practical, effective, and efficient System must be practical, effective, and efficient · Triggers and procedures must work Triggers and procedures must work · Requirements and standa Requirements and standards must be achievable rds must be achievable · Complexity should be commensurate with activity Complexity should be commensurate with activity and level of risk and level of risk · Levels of inspection and auditing should be Levels of inspection and auditing should be consistent with available resources – consistent with available resources – human, human, financial, infrastructure financial, infrastructure

Categories of information Categories of information · Administrative Administrative · Unmodified host organism Unmodified host organism · Transgenic plant Transgenic plant · Trial site location Trial site location · Trial protocol – Trial protocol – purpose of the trial urpose of the trial

Administrative information Administrative information · Who is the applicant? Who is the applicant? – this is the legally his is the legally responsible person; the person to which all responsible person; the person to which all future correspondence is addressed future correspondence is addressed · Is this a new application or a renewal? Is this a new application or a renewal? · Is any material intended for experimental Is any material intended for experimental evaluation in livestock feed? evaluation in livestock feed? · Does the applicant want to retain any Does the applicant want to retain any material from the trial? material from the trial? · Other permits obtained/required (Import Other permits obtained/required (Import Permit, use of unregistered pesticides) Permit, use of unregistered pesticides)

The unmodified plant The unmodified plant · Information on the biology of the Information on the biology of the unmodified host plant unmodified host plant · May only be required if the regulator does May only be required if the regulator does not already have a biology document for not already have a biology document for that plant species that plant species · Fertility, phenotypic characteristics, habitat, Fertility, phenotypic characteristics, habitat, normal cultivation and breeding practices normal cultivation and breeding practices · Knowledge of the unmodified plant is Knowledge of the unmodified plant is crucial to designing rational methods of crucial to designing rational methods of reproductive isolation reproductive isolation

The transgenic plant The transgenic plant

· Based on scientific understanding of the function of the introduced gene(s), we need to address two main questions: · 1. Will the standard conditions of reproductive isolation for the unmodified plant also apply for the transgenic plant?

– Is the introduced gene Is the introduced gene antici anticipated pated to affect some to affect some aspect of the plant’s reproductive biol aspect of the plant’s reproductive biology?

• gy?

– Is the gene integrated wi Is the gene integrated withi thin the nucl the nuclear genome? ear genome? – Do Do we we expect expect that the introduced DNA would give rise that the introduced DNA would give rise to a pathogeni to a pathogenic agent? agent?

The transgenic plant (cont’d) The transgenic plant (cont’d)

• 2. Have we knowingly introduced an allergen
• 2. Have we knowingly introduced an allergen
• r toxin?
• r toxin?

– If so, additional risk mitigation measures If so, additional risk mitigation measures may be necessary (i.e. some protection for may be necessary (i.e. some protection for workers handling that material) or increased workers handling that material) or increased level of inspection may be necessary to level of inspection may be necessary to ensure that no material is entering food/feed ensure that no material is entering food/feed supply supply

The trial site The trial site

· Location of the trial site Location of the trial site · Field manager Field manager · How is the trial site being marked? How is the trial site being marked? · Are there any sexually compatible wild species in Are there any sexually compatible wild species in the vicinity? the vicinity? · Land use and responsible person during post- Land use and responsible person during post- harvest period harvest period · Is it on agricultural land or is it part of a “natural Is it on agricultural land or is it part of a “natural ecosystem”? – ecosystem”? – is it near to, or part of, a protected s it near to, or part of, a protected area? Are there any endangered species in the area? area? Are there any endangered species in the area?

Trial protocol Trial protocol · Purpose of the trial Purpose of the trial · Proposed methods of reproductive isolation Proposed methods of reproductive isolation · How is transport, planting, monitoring and How is transport, planting, monitoring and harvesting going to be carried out? harvesting going to be carried out? · Is any plant material to be retained after the Is any plant material to be retained after the trial? (for experimental use) trial? (for experimental use) · Public notification? Public notification?

Relevant questions Relevant questions

· Focus on issues of relevance to reproductive Focus on issues of relevance to reproductive isolation – isolation – i.e., mitigating gene flow through .e., mitigating gene flow through

• utcrossing
• utcrossing

· Focus on issues related to controlling the Focus on issues related to controlling the movement, handling, and fa movement, handling, and fate of all plant material te of all plant material · Focus on issues related to control over the trial site Focus on issues related to control over the trial site · Everything else is “nice to know” not “need to know” Everything else is “nice to know” not “need to know” for confined trials for confined trials

Adaptability Adaptability

· New applications of biotechnology are evolving New applications of biotechnology are evolving rapidly and regulatory requirements and/or rapidly and regulatory requirements and/or guidelines must be able to adapt quickly guidelines must be able to adapt quickly · Technical requirements should be defined in Technical requirements should be defined in guidelines or directives rather than in statutory guidelines or directives rather than in statutory regulations or laws regulations or laws · Flexibility must exist to accommodate case-by-case Flexibility must exist to accommodate case-by-case variations variations · As confidence and experience grows with particular As confidence and experience grows with particular (trait x species) combin (trait x species) combinations, provisions for ations, provisions for expedited or ‘short-track’ reviews desirable – expedited or ‘short-track’ reviews desirable – may ay be especially true in the case of confined field trials be especially true in the case of confined field trials

Administrative Administrative

· Receipt of applications and processing Receipt of applications and processing · Issui Issuing legally binding autho g legally binding authorization (permit or letter of rization (permit or letter of authorization) stipulating terms and conditions of authorization) stipulating terms and conditions of authorization authorization · Coo Coordinate with other pe dinate with other permit issue rmit issuers (Plant s (Plant Impo Import rt, Pe , Pest st Cont Control) rol) · Coordinate inspection and enfo Coordinate inspection and enforcement activities (24 x 7) rcement activities (24 x 7) including administrative and monetary penalties including administrative and monetary penalties · Recei Receipt and handling of reports – t and handling of reports – record of planting, ecord of planting, record o record of harvest/te harvest/termination, end o rmination, end of t trial re rial repo port rt · Publication of notices/repo Publication of notices/reports – rts – reco ecord of decision, d of decision, compliance information, summary statistics compliance information, summary statistics · Single point o Single point of contact contact

Technical evaluation Technical evaluation · Access to specific scientific expertise – Access to specific scientific expertise – plant lant breeding, plant physiology, plant pathology, breeding, plant physiology, plant pathology, molecular biology (case by case) molecular biology (case by case) · Science-based risk mitigation measures Science-based risk mitigation measures (terms and conditions of authorization) (terms and conditions of authorization) · Advice for risk management Advice for risk management

Inspection and enforcement Inspection and enforcement

· Legal powers of an inspector – Legal powers of an inspector – enter, detain, seize, nter, detain, seize, examine records examine records · Trained inspection staff – Trained inspection staff – specific training for pecific training for inspecting confined field trials inspecting confined field trials · Diagnostic and testing capability – Diagnostic and testing capability – required in the equired in the case of trace-back or verification case of trace-back or verification · Able to take enforcement action – Able to take enforcement action – require trial equire trial destruction destruction · Emergency response Emergency response

Final messages Final messages

· Confined Confined and and unconfined unconfined activities are activities are distinct distinct and there should be a separate and there should be a separate review and approval process for each review and approval process for each · The The questions questions that need to be considered that need to be considered for confined trials for confined trials ARE different ARE different to the to the questions for unconfined release questions for unconfined release · Confined field trials Confined field trials CAN CAN be performed be performed safely safely and and routinely routinely