croplife international compliance management programme … international compliance management...
TRANSCRIPT
Representing the Plant Science Industry
Field Trials of Experimental, Genetically Engineered Plants
CropLife International Compliance Management Programme for Confined
Field Trials
Issues that we are NOT dealing with during this workshop
Globalization
Risks
Benefits
Grower Satisfaction
Public Trust
RegulatoryOversight
Labelling Testing andTraceability
CommodityMarkets
SegregationIdentity Preservation
Openness andTransparency
RiskCommunication
SocialAcceptability
Confined Trials
· For 2004, it is estimated that total acreage 200 million – a 20% increase over 2003
· More than 8.25 million farmers are growing transgenic crops, 90% of these are resource-poor farmers in developing countries
· The percentage growth in area between 2003 and 2004 in developing countries (35%) was almost 3X greater than for industrialized countries (13%)
Continued growth in GM crop area
Global Area of Transgenic Crops(Source: Clive James, 2004)
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1996 1997 1998 1999 2000 2001 2002 2003 2004
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Industrial Developing
Distribution of GM crops by country
· In 2004, six countries grew 98% of the global GM crop area– USA – 59%– Argentina – 20%– Canada – 6%– Brazil – 6%– China – 5%– Paraguay – 2% 0
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1996 1998 2000 2002 2004
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Acreage of Transgenic Crops by Country
(Source: Clive James, 2004)
USA Argentina Canada China
· Nearly all of the area planted to transgenic crops is accounted for by four crops, which in 2004 were represented by:– Soybean – 60%– Maize – 23%– Cotton – 11%– Canola – 6%
Distribution of GM crops by crop
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1996 1997 1998 1999 2000 2001 2002 2003 2004
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Global Acreage by Crop(Source: Clive James, 2004)
Soybean Maize Cotton Canola
· Of the global aggregate area of these 4 crops (710 M acres) in 2004, 29% was planted to biotech varieties.
· In 2004, the global market value of biotech crops was estimated at $4.7 billion, representing 16% of the $30 billion global commercial seed market
Global adoption of GM soy, cotton, canola & maize
Global Area Adoption Rates by Crop
(Source: Clive James, 2004)
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Soybean Cotton Canola Maize
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Transgenic Total
· Broader application of plant biotechnology products needs a system in place to permit the safe conduct of confined field trials.
· Capability to safely perform confined trials is equally important in both industrialized and developing countries.
· A system must exist whereby locally developed and foreign applications can be assessed and evaluated for potential biosafety impacts.
Global snapshot: Africa
sugar canesoya
Global snapshot: Asia
Global snapshot: Central & Eastern Europe
I think we should change this to Europe including the new accession states
Global snapshot: Central & South America
Regulatory framework for confined field trials in the Philippines
Roles
CBI
Timeframes
Terminology
· Contained use (laboratory, greenhouse, screenhouse)
· Confined environmental release (field test)
· Unconfined environmental release (commercialization)
Expe
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What is a confined field trial?
· A confined field trial is a small-scaleexperimental field trial of a genetically engineered plant species carried out to collect the data necessary for a complete environmental risk assessment that is performed under terms and conditions that mitigateimpacts on the surrounding environment
Trials we are all familiar with
· Breeders’ trials (experimental)– Agronomic evaluation of new crosses– Evaluation of new germplasm, perhaps
imported from elsewhere· Variety registration trials
– Performance trials, demonstration of merit (value)
· Plant breeders’ rights trials– DUS – demonstration of distinctness,
uniformity, and stability
Purpose of confined field trials
· For the breeder – to collect agronomic performance data (efficacy of the modification, yield, etc), same as for a conventional trial
· To collect data to complete the environmental risk assessment– Secondary effects on non-target organisms– Morphological characterization – seed dissemination,
dormancy of seed, germination rate, time to maturity, disease and pest resistance
· To generate data for variety registration
Purpose of confined field trials (cont’d)
· To produce material for livestock feed performance trials
· To produce material for food safety evaluations (raw seed/grain and derived fractions)– Nutritional compositional analysis (proximates, amino
acids, fatty acids, minerals, vitamins, etc)– Levels of endogenous antinutrients, toxicants, and
allergens· Data are usually collected from trials in multiple
locations, representing a range of growing conditions, and over multiple years
Confined field trials
Most lines in confined field trials do NOTend up as products
ContainedLaboratory
Experimentation
ConfinedField Trial
Experimentation
100’s – 1000’sPotential Lines
10 - 100Potential Lines
1 – 4 Lines Submitted forUnconfinedApproval
New trait moved into10 – 100 varieties usingTraditional breeding
Post-approvalUse of new line
In breeding programs
Application forUnconfined (commercial)
Release
Application forConfined Field
Trial
Risk management approach
· The necessity of being able to safelyevaluate plants of uncertain risk cannot be over emphasized.
· A crucial distinction between unconfined environmental releases and confined trialsthat has not been sufficiently appreciated in some countries, either by regulators, national biosafety committees, or capacity builders and trainers.
Risk management approach
· At the level of an unconfined release, the focus must be on rigorous risk assessmentas the intent is widespread introduction of the modified plant into agriculture, usually with few or no restrictions.
· Conversely, for confined trials the risks may not yet be fully understood without data collected during the trial, hence the focus must be on risk management – the terms and conditions that are necessary to permit safe trial conduct.
Risk = Exposure x Hazard
· The risk management approach recognizes that hazards may not fully understood for field trials, so the focus is on preventing exposure by implementing specific mitigation measures
· Risk assessment is about hazardidentification and characterization, and exposure estimation
· Hazards can be:– Probabilistic– Hypothetical– Speculative
“3-Ps” of risk management for field trials
Aim to:
· Prevent dissemination of new genes in experimental transgenic plant into and within the environment (ieprevent pollen-mediated gene flow)
· Prevent the persistence in the environment of the experimental transgenic plant and any progeny plants
· Prevent the introduction of the experimental transgenic plant (or products) into the livestock feed and human food pathways
Confined trial process
Application Permit Planting Harvest/Termination Completion
TechnicalReview
RegulatoryDecisionLegal AuthorizationWith Terms & Conditions
Regulatory Inspections
Current Season Post-Harvest Period
Preventing dissemination of new genes
· Impose conditions of reproductive isolation on all plants within the trial site
· Practically, reproductive isolation = means used to control the movement of pollen from the trial site
· Ensures that new genes are not introgressedinto neighbouring plants of the same or a sexually compatible species
Purpose of reproductive isolation
· Prevent dissemination of new genes in experimental transgenic plant into and within the environment – prevent pollen-mediated gene flow and seed dispersal
· Three main methods– Spatial isolation– Physical isolation– Temporal isolation
GrapesTransgenicmaize
40 footBorder50 foot
FallowConfined maize trials in
the U.S.
Cotton
Preventing persistence in environment
· Imposing conditions of post-harvest land use restriction and post-harvest monitoring for volunteers– i.e. no planting of the same plant species
· Period of post-harvest restriction depends on the plant species– ie: seed dormancy characteristics
· Volunteers, related species and weedy relatives (where applicable) must be removed from the post-harvest site before flowering
Preventing introduction into food/feed chain
Controlling the· movement of plant material onto and off of the trial
site (transport and cleaning of any machinery used)· storage of plant material· disposal of residual or excess plant material on the
trial site – excess planting materials, material remaining after harvest, material from roguing, detasseling or deflowering activities
· disposition of any material retained after harvest
Terms & conditions + inspection & enforcement· The questions asked in applications for a
confined field trial should relate directly to confinement issues
· All of the provisions under the “3-Ps” should be reflected in the terms and conditions of authorization of a confined field trial
· Adherence to the terms and conditions must be verified through inspection / auditing by the regulatory authority
Safety record
· The combination of science-based risk management T&Cs plus adequate inspection will contribute to the safe conduct of confined field trials
· Over the last 17 years (since 1987), more than 15,000 field trials have been conducted in numerous countries around the world
· There is not a single documented example of actual “harm” to the environment or to people or animals
Contingency planning
· Applicants should be asked to provide contingency plans for responding to accidental breaches of confinement
· Key elements should include– The procedure for notifying the regulatory
authority– Measures for destroying the transgenic plant– Supervision and safety procedures– Communication strategy– Diagnostic methods to trace back if
necessary
Developing a regulatory system
Considerations:
· Stipulating the permissible means of achieving reproductive isolation (crop by crop)
· Defining schedules (intervals) for current season and post-harvest monitoring
· Defining periods of post-harvest land use restriction (crop by crop)
· Defining record-keeping requirements – activity based
· Levels of inspection – current season, post-harvest period, facilities
Common requirements of a regulatory system
· Clarity
· Transparency
· Consistency
· Workability and enforceability
· Adaptability
Clarity
· Unambiguous (ie: scope and objectives)
· Clear differentiation between different activities (ie: contained use, confined trials, unconfined releases, commodity imports/exports) – different application and review processes
· Clear division of responsibilities between government ministries (ie: food/feed vs. environment, etc)
· Clear interrelation with other existing regulatory systems (ie: seeds regulations, plant import and quarantine, etc)
Transparency
· The applications system for permits and/or authorizations must be clearly communicated– When and where applications are to be submitted– What is to be included in the application (ie: information
requirements)– Time standards for review and reporting
· How is science advice provided and taken into account– External review, expert panels, government science
evaluators· Basis of regulatory decision-making
– How are decisions made and by whom– Independence and impartiality
· What information is to be disclosed to the public and when· Treatment of confidential business information
Workability
· System must be practical, effective, and efficient
· Triggers and procedures must work
· Requirements and standards must be achievable
· Complexity should be commensurate with activity and level of risk
· Levels of inspection and auditing should be consistent with available resources – human, financial, infrastructure
Categories of information
· Administrative
· Unmodified host organism
· Transgenic plant
· Trial site location
· Trial protocol – purpose of the trial
Administrative information
· Who is the applicant? – this is the legally responsible person; the person to which all future correspondence is addressed
· Is this a new application or a renewal?· Is any material intended for experimental
evaluation in livestock feed?· Does the applicant want to retain any
material from the trial?· Other permits obtained/required (Import
Permit, use of unregistered pesticides)
The unmodified plant
· Information on the biology of the unmodified host plant
· May only be required if the regulator does not already have a biology document for that plant species
· Fertility, phenotypic characteristics, habitat, normal cultivation and breeding practices
· Knowledge of the unmodified plant is crucial to designing rational methods of reproductive isolation
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 anticipated to affect some
aspect of the plant’s reproductive biology?– Is the gene integrated within the nuclear genome?– Do we expect that the introduced DNA would give rise
to a pathogenic agent?
The transgenic plant (cont’d)
2. Have we knowingly introduced an allergen or toxin?– If so, additional risk mitigation measures
may be necessary (i.e. some protection for workers handling that material) or increased level of inspection may be necessary to ensure that no material is entering food/feed supply
The trial site
· Location of the trial site· Field manager· How is the trial site being marked?· Are there any sexually compatible wild species in
the vicinity?· Land use and responsible person during post-
harvest period· Is it on agricultural land or is it part of a “natural
ecosystem”? – is it near to, or part of, a protected area? Are there any endangered species in the area?
Trial protocol
· Purpose of the trial· Proposed methods of reproductive isolation· How is transport, planting, monitoring and
harvesting going to be carried out?· Is any plant material to be retained after the
trial? (for experimental use) · Public notification?
Relevant questions
· Focus on issues of relevance to reproductive isolation – i.e., mitigating gene flow through outcrossing
· Focus on issues related to controlling the movement, handling, and fate of all plant material
· Focus on issues related to control over the trial site
· Everything else is “nice to know” not “need to know” for confined trials
Adaptability
· New applications of biotechnology are evolving rapidly and regulatory requirements and/or guidelines must be able to adapt quickly
· Technical requirements should be defined in guidelines or directives rather than in statutory regulations or laws
· Flexibility must exist to accommodate case-by-case variations
· As confidence and experience grows with particular (trait x species) combinations, provisions for expedited or ‘short-track’ reviews desirable – may be especially true in the case of confined field trials
Administrative
· Receipt of applications and processing
· Issuing legally binding authorization (permit or letter of authorization) stipulating terms and conditions of authorization
· Coordinate with other permit issuers (Plant Import, Pest Control)
· Coordinate inspection and enforcement activities (24 x 7) including administrative and monetary penalties
· Receipt and handling of reports – record of planting, record of harvest/termination, end of trial report
· Publication of notices/reports – record of decision, compliance information, summary statistics
· Single point of contact
Technical evaluation
· Access to specific scientific expertise – plant breeding, plant physiology, plant pathology, molecular biology (case by case)
· Science-based risk mitigation measures (terms and conditions of authorization)
· Advice for risk management
Inspection and enforcement
· Legal powers of an inspector – enter, detain, seize, examine records
· Trained inspection staff – specific training for inspecting confined field trials
· Diagnostic and testing capability – required in the case of trace-back or verification
· Able to take enforcement action – require trial destruction
· Emergency response
Final messages
· Confined and unconfined activities are distinct and there should be a separate review and approval process for each
· The questions that need to be considered for confined trials ARE different to the questions for unconfined release
· Confined field trials CAN be performed safely and routinely