Confinement

In a confined field trial, researchers are able to safely evaluate crops with new genetic traits. The regulation, conduct and oversight of CFTs needs a practical, integrated approach spanning all aspects of the trial, from the inception of planning to successful completion and reporting. Further details and useful resources can be found in this section.

1. What is the objective of a confined field trial?
   
   A confined field trial (CFT) is an experiment in the open field. The aim is to test and evaluate the performances of one or more lines of a crop with a new trait(s) introduced by genetic modification (GM).
   
   CFTs are conducted on a small scale (often 1 ha or less), and often on an official experiment station. Risk is mitigated by controlling the likelihood of exposure of humans or the environment to new genes or plant material.
   
   Field experiments are a key step in the routine development of crop varieties, regardless of whether these varieties are produced by conventional plant breeding or by advanced techniques of modern biotechnology. Field trials allow the breeder to determine the performance of the new variety in realistic conditions over a range of locations and environments.
   
   Field trials of lines of a GM crop may have a number of objectives:

   • Evaluate the plant characteristics (phenotype) and/or test the agronomic performance of the newly produced GM lines
   • Determine how well the engineered traits are expressed, their effectiveness under natural conditions, and select the best performing lines
   • Collect biosafety data for presentation to regulatory authorities
   • Produce plant material for further studies on food safety
   • Incorporate, through conventional breeding the desired traits into local varieties which are better adapted to the local environmental conditions

2. How do you “confine” a field trial?
   
   Confinement refers to measures taken to prevent escape of GM materials outside the trial site.
   
   CFTs require appropriate management measures to:

   • ensure reproductive isolation: prevent plants from pollinating compatible species and producing seed that escapes from the trial site
   • ensure the effective confinement of the experimental GM material so that it is not eaten by humans or livestock
   • prevent the persistence of the GM material in the environment by ensuring that the GM materials and any volunteers arising from the trial are completely destroyed.

   
   Different confined field trials can use different methods to achieve confinement. Not all trials use every method. Examples include:

   • Isolation distance – separation of the crop species from other plantings of the same species (i.e., maize and maize) at a sufficient distance to prevent pollen exchange.
   • Removal of reproductive parts such as flowers or fruits if not needed to obtain desired information.
   • Planting in a location with restricted access.
   • Remove all materials at the end of the planting season
   • Monitor for growth in seasons after the trial is completed

   
   For more detailed information see Halsey, M. 2006. Integrated Confinement System for Genetically Engineered (GE) Plants. St. Louis, Missouri, USA: Donald Danforth Plant Science Center (133 pp)

3. How is a confined field trial regulated?
   
   Confined field trials with GM plants are regulated by national regulatory authorities. They require official approvals prior to planting.
   
   Confined field trials are experiments carried out in the testing and development stage. They are conducted prior to approval for use by the public (also called general or unrestricted release). Therefore, CFTs can be initiated with only minimal safety data.
   
   A CFT is regulated through a series of interactions between the Regulatory Authority and the Technology Developers (Figure 1).
   Figure 1:A Generalized Scheme for the Approval, Safe Conduct and Monitoring of Confined Field Trials. (From Halsey, 2006. By permission).The terminology used for the different parties and documents may vary somewhat from country to country, but the basic process remains the same, including:

   1. Establishment of a Regulatory Authority. A country wishing to implement testing of GM plants must first have in place an official body or system at the national level that is legally mandated to serve as the Competent Authority (Regulatory Authority) for regulation of GM plants, and to consider CFT applications.
   2. The Regulatory Authority develops an Application Form that clearly indicates the information required from the Technology Developer (Click here for an example of an application from Halsey, 2007). The mechanism of submitting an Application, and the expected time period for review and decision should be clearly indicated to the Applicant by the National Authority.
   3. The Technology Developers submit an Application to the Regulatory Authority, which describes the technology, objectives for testing and methods to achieve confinement.
   4. The Regulatory Authority considers the Application and issues a Decision Document describing their deliberations and decisions. Once the Application is received, the Regulatory Authority begins the decision making process according to its Internal Operating Procedures (IOP), and criteria for approval or rejection. Those criteria include the technical merits of the Application and also any other considerations pertinent to the particular country’s national policy and priorities.
   5. If the Application is approved, the Regulatory Authority issues a Letter of Authorization to the Technology Developer, citing Terms and Conditions for carrying out the approved CFTs. Authorization is issued with Conditions that clearly indicate the confinement measures that the Authorized Party (the holder of the permit or license) shall consider.
   6. The Applicant provides reports on when the field was planted, the confinement practices utilized, any unanticipated events, the date when the trial was terminated and how it was done.
   7. While the trial is in progress, the Regulatory Authority may monitor the trial for compliance with confinement conditions.

   
   A description of the process, suggested formats for the CFT Application and other required documents and data capture forms, model Standard Operating Procedures for trial conduct and Internal Operating Procedures for Regulators may be found in Halsey (2006).
   

4. What information is included in a confined field trial application?
   
   The information required in a CFT generally includes:

   • the identification of the Applicant
   • the plant species that has been modified
   • the new genes that have been inserted and the phenotype conferred
   • the donor organisms from which the new genes originate
   • the transformation method used to insert the genes
   • the location of the trial sites
   • the size of the trial
   • the date and expected duration of the trial
   • the confinement measures, i.e.,
     • the genetic confinement measures
     • the material confinement measures
   • SOPs should be developed for:
     • shipping, transport and storage of GM materials,
     • methods of reproductive isolation and material: confinement Isolation distances, i.e., based on certified seed production requirements physical means such as fences
     • field site maintenance and monitoring
     • harvest disposal
     • post-harvest management
     • planning for unexpected events or emergencies
     • record keeping and reporting

   
   NOTE: Because CFTs are confined, and purposes include both performance evaluation and collection of safety data, they are carried out prior to a full and comprehensive risk-assessment.
   
   For more detailed information see Halsey, M. 2006. Integrated Confinement System for Genetically Engineered (GE) Plants. St. Louis, Missouri, USA: Donald Danforth Plant Science Center (133 pp)

5. What factors should be considered in approving a CFT?
   
   In regulating a CFT, the key issue is to ensure the safety of the trial.The Authorized Party must ensure two major objectives: (i) Reproductive isolation, also known as genetic confinement and (ii) material confinement.Genetic and material confinement:

   • prevent the new genes (contained in pollen, seeds or any other part of the plan) from escaping the trial site
   • prevent the GM plant material from being consumed by humans or livestock,
   • prevent the GM plant materials from escaping, establishing and persisting in the environment

   
   These three objectives are considered to be the pillars of effective confinement. They need to be considered at all aspects of the trial, including: (i) the shipping, transport and storage of the GM material; (ii) the field management during the period of the trial; (iii) the post harvest management and (iv) the contingency.

   The Regulatory Authority evaluates the biosafety aspects of the technology to be tested, the scope of the testing proposed, and the biosafety measures the Applicant proposes to use.

   Kinds of questions to be considered include:

   1. Are the confinement protocols appropriate for the crop? (will they prevent gene movement to other members of the same species/interfertile species? Will they prevent seed or fruit movement or movement of other propagative materials? What measures will prevent the crop from persisting or re-seeding after the trial is completed? How will the plot be monitored after the trial is completed?)
   2. Is the location appropriate? (how far is it from production fields of the same species? Is access to the location restricted?)
   3. Is the test plant a noxious weed?

   
   For more detailed information see Halsey, M. 2006. Integrated Confinement System for Genetically Engineered (GE) Plants. St. Louis, Missouri, USA: Donald Danforth Plant Science Center (133 pp).

6. How do I ensure there is adequate genetic confinement in a CFT?
   
   Genetic confinement aims to prevent gene flow from the GM plants being tested to sexually compatible crops or to wild relatives outside the site of the trial. Several methods and techniques are used, among which the isolation distance is the most common.
   
   Isolation distance
   
   Isolation by distance is a well-established method used when breeders develop new conventional plant varieties and also in certified seed production. Specific guidelines have been developed and published by official bodies such as AOSCA (www.aosca.org) and OECD (www.oecd.org) that serve as basis for countries to establish their own standards. The same principles of reproductive isolation by distance are used for confined field trials with GM plants.
   
   The isolation distance varies with the reproductive characteristics of crops and depends to a large extent on the level of out-crossing. For example, sunflower (Helianthus annuus) which is highly out-crossed requires up to 800 m of isolation distance, while crops such as soybean (Glycine max) and rice (Oryzae sativa) are predominantly self-pollinated and may require only a few meters to achieve effective genetic confinement. See the AOSCA and OECD documents for specific crop recommendations.
   
   Other strategies that can be used in combination with isolation distances

   • Planting of a continuous border of non-GM plants around the GM crop, to serve as a pollen trap. In this case, the surrounding border must not have any continuous gaps or alleyways, and the plants must flower at the same time as the GM crop being confined,
   • Bag, or remove entire flowers. This is a common method used for maize and for cassava;
   • Testing GM crops in the CTF that have different flowering times than other test plots of the same species or sexually compatible relatives in the vicinity.

   
   For more detailed information see Halsey, M. 2006. Integrated Confinement System for Genetically Engineered (GE) Plants. St. Louis, Missouri, USA: Donald Danforth Plant Science Center (133 pp).

7. What steps should be taken after a CFT is terminated?
   
   At the end of the CFT, the GM plant material in the trial site should be destroyed to prevent it from being eaten by humans or livestock. Many strategies are used to ensure effective disposal, including burning or ploughing under all plant residues.
   
   The post trial follow-up should also include monitoring and destroying volunteers of the regulated GM plants for a period of time during which they are likely to appear. This ‘volunteer monitoring period’ depends on the crop species and the environment.
8. What type of reporting is necessary for a CFT?
   
   Keeping records and reporting is mandatory in conducting CFTs. Observations should be made on the phenotype of the experimental GM plants, the confinement practices used in the CFT, and any unanticipated effects of the GM trait.
   
   The type of information to be recorded, the timing and types of reports that are required are determined by the Regulatory Authority in the Terms and Conditions attached to the permit for implementation (see Halsey, M. 2006. Integrated Confinement System for Genetically Engineered (GE) Plants. St. Louis, Missouri, USA: Donald Danforth Plant Science Center (133 pp) for suggested report formats).