FAQs and General Information
Greenhouse Trials of Genetically Modified Crops: Q&A
Greenhouses and similar plant growth facilities are required for studying the biological attributes of plants with new genetic traits. At this stage, the challenge is to contain such plants within a secure facility. This section provides for a better understanding of regulatory issues and relevant procedures for greenhouse trials with GM plants.
- Introduction
This section provides information on greenhouse trials of GM plants, relevant for a better understanding of the regulatory issues. It focuses on plants and does not deal with plant associated organisms i.e. insects, microbes, virus that are also subject to containment. For information on these organisms, see:
http://www.isb.vt.edu/documents/Plant%20Contain.text.PDFX-1a.pdf
- Why perform greenhouse trials of GM plants?
Greenhouse trials are the first step in evaluating the performance of GM plants. They are also used to propagate GM plants outside of a tissue culture environment, for the purpose of breeding into advanced germplasm or maintaining material under less costly conditions. Greenhouse trials present opportunities to study plant growth and performance in a contained environment.
- How is biosafety ensured in greenhouse trials?
Greenhouses, like laboratories, are research facilities that ensure the required levels of containment for research with regulated plants. Contained activities refer to “any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment. In other words, containment uses physical barriers to restrict the spread of experimental organisms.The level of containment is determined by the degree of biosafety concern associated with the experiment being conducted. See Q and A’s below on “biosafety levels.”In conducting greenhouse trials of GM plants, the biosafety objective is to prevent the spread of the GM materials from inside the greenhouse to receptive environments outside the greenhouse.
- Are greenhouse GM trials regulated?
Generally, all experiments with GM materials, including those in the greenhouse, are regulated prior to unrestricted release.Conditions required for a country to allow greenhouse trials of GM plants include:
- national laws and regulations in place allowing for GE crop testing (regulations can be based on existing regulations), with specific guidelines and/or manuals for greenhouse experiments
- a regulatory body in place, able to make science based decisions
- Who is responsible for the safe conduct of greenhouse trials with GM plants?
The overall biosafety of a greenhouse trial with GM plants is ensured by a combination of competent scientists, biosafety committees, and regulators.A greenhouse trial is a scientific experiment that is conducted by competent staff under the responsibility of scientists from the public research sector or a private company. Public and private research facilities involved in modern biotechnology commonly have an established institutional biosafety committee (IBC).The trials must be approved by the respective IBC and national biosafety committees. Biosafety committees also provide oversight and can assist scientists in complying with the rules by providing training and information.Regulatory bodies are responsible for setting rules that are required for safe conduct of the greenhouse trials and for ensuring that the rules are observed.
- How do regulators ensure safety in greenhouse trials with GM plants?
The regulators’ responsibilities include the following key activities:
- Developing application forms for greenhouse trials, for submission either to government authorities or institutional biosafety committees
- Reviewing applications for greenhouse trials, in order to issue permits / authorization
- Conducting inspections to make sure of compliance with applicable regulations.
- How do scientists ensure safety in greenhouse trials with GM plants?
The responsible scientists must:
- determine the appropriate biosafety level for the designated trial, taking into account the characteristics of the crop species, the gene inserted and the receiving environment outside the greenhouse,
- choose and use the appropriate greenhouse features,
- determine appropriate standard practices in managing the activities in the greenhouse
The scientists are responsible to carry out the experiments in accordance with the standard operating practices (SOPs) and regulations.
- What are greenhouse biosafety levels?
Greenhouse trials of GM plants are assigned a biosafety level that determines the appropriate level of containment.Greenhouse biosafety levels are based on the biological characteristics of the plant species, the source and nature of the inserted gene, and the local environment. The plant species weediness, reproductive characteristics, and the presence or absence of sexually compatible relatives in the surrounding environment are the most critical criteria considered.
- Biosafety Level 1 is assigned to experiments with transgenic plants that are not able to reproduce or spread in the environment and pose no other environmental risks.
- Biosafety Level 2 is assigned to experiments with transgenic plants that could survive and reproduce outside the greenhouse, but would have, at most, negligible impacts that could be easily managed.
- Biosafety Level 3 is assigned to experiments with transgenic plants that are known to have negative impacts on the environment.
- Biosafety Level 4 is assigned to experiments that involve transmissible, infectious agents with potential harm to other crops.
This classification is just an example, based on US NIH biosafety levels. Other classifications may exist For more information on this example see: http://www.isb.vt.edu/documents/Plant%20Contain.text.PDFX-1a.pdf , Section III pages 11- 16.
Actually, biosafety levels 3 and 4 may have never been used since they have has not been warranted.
In most cases, the conventional greenhouses typically used in research stations can be used or modified for transgenic plant experiments, if proper practices are developed and followed. Costly new constructions are generally not needed for levels 1 and 2.
- How is containment assured in greenhouse trials?
Containment in a greenhouse is assured through a combination of physical structure and appropriate standard operating practices.
Physical Containment MeasuresCommon physical containment measures include:
- choice of appropriate location and site for the greenhouse, taking into account the level of containment required, the ecological characteristics of the local environment, and ability to restrict access
- use and maintenance of appropriate structural features for the greenhouse, such as:
- glazing and caulking
- screens with appropriate size of holes for excluding undesirable pests and insects, as well as pollinators
- cages within the greenhouse to ensure more efficient containment, if needed
- appropriate drainage systems that do not allow materials to enter public sewage systems or waterways without prior treatment or time for live material to die.
For a more complete list and more information see http://www.isb.vt.edu/documents/Plant%20Contain.text.PDFX-1a.pdf, Section IV, p. 17-26
Standard operating practices (SOPs)
Researchers conducting greenhouse trial must develop SOPs appropriate to the crop, location, and nature of trial. In general SOPs describe and provide answers on:
- how the greenhouse and its equipment will be used and maintained
- how the plant materials will be handled, transported, and disposed
- how visitors will be managed and security maintained
- how containment breach and emergencies will be managed
The SOPs should be regularly updated, and must be rigorously followed by all staff members involved in the trial.
- What kinds of information are necessary in an application for a greenhouse trial of GM plants?
General
- What is the objective of the trial? Provide a brief description.
- What is the common and scientific name of the GM crop?
- Are there compatible relatives growing in the area, either on the facility grounds or outside of the facility grounds?
- What is the nature of the genetic modification, i.e. the target gene product and its function?
Greenhouse
- What type of greenhouse is it (Glass, lexan, plastic poly, screen or other)?. If screen, what size mesh? If Poly, what thickness?
- What is the floor plan of the facility? What are the approximate inside and outside dimensions of the greenhouse?
- How will the greenhouse be secured from public access and unauthorized personnel? Can individual laboratories be locked? Will there be signs posted on the facility door stating that a regulated genetically engineered organism is present?
- How is the greenhouse entered? Does the greenhouse have a double door entry system? Is the greenhouse entry through a “headhouse”? Do the greenhouse doors have locks? Is there a rear exit door?
- Are there any openings in the greenhouse through which animals and pollinating insects could enter? Do the roof vents open? If the roof vent opens, is it screened? What size is the screen mesh? Does the greenhouse have black light traps for vectors? Does the greenhouse have “Sticky Board” traps for vectors? Does the greenhouse have other kinds of vector traps?
- What kind of floor does the greenhouse have (concrete, gravel, packed dirt, or other)? Are there any cracks or irregular surfaces that could trap seeds?
- Does the greenhouse have water drains? Are the drains screened? If so, what is the size of the screen? Does the drain system enter into a special waste trap?
GE Material Handling and Transport
- How will the regulated articles be physically marked and identified? Will there be physical markers on each plant or container indicating that the plants are genetically engineered? How will the regulated articles be kept separate from other organisms?
- Describe how seeds, plant material and tissue cultures will be stored. Will there be a storage cabinet? Can it be locked? Will the storage container identified with a sign stating it contains a genetically engineered organism?
- What medium will be used for seed germination and plant growth? Is there any danger of seeds or plant material being lost during germination, or of ungerminated seed being transferred into subsequent research stages?
- How will the plants be grown in the greenhouse (on benches, in flats, in pots or other)?
- How will GM material be transported between labs, chambers, and greenhouses? What kinds of spill response action plan/equipment are available for items spilled in transit between labs, chambers, and greenhouses?
- Where is the autoclave or incinerator in relation to where the plants will be grown?
Record Keeping
What kind of records, logs, or inventory will be maintained during the experiment regarding receipt, increase, and destruction of regulated articles?
Adapted from information provided in:
- How are inspections of greenhouse trials conducted?
Inspection is critical to make sure that containment measures are appropriate and applied properly. Greenhouse facilities may be inspected by the regulatory authority prior to the issuance of the permits. Afterwards, these facilities should be inspected periodically. Inspections are often conducted by institutional biosafety personnel instead of government regulatory authorities.In order to efficiently conduct inspections, two important actions must be taken: (i) appoint an inspection body, (ii) develop an inspection checklist.
- Who are the inspectors?
The composition of the inspection body can vary. Inspectors may include the greenhouse manager, the biosafety officer, the IBC representative, or state or national agricultural officials. In many African countries like Uganda and Burkina Faso, Biosafety inspectors are mainly from the ministry responsible for agriculture and/or for the environment.
- What does the inspection checklist look like?
A checklist is a key tool to facilitate conduct of the inspection. The list of questions to be asked may vary according to the nature of the trial and any specific situation, but must at least provide information on:
- the nature of the experiment
- the level of biosafety assigned to the trial,
- the suitability of the facility and equipment,
- the containment measures applied, both physically and biologically,
- the SOPs and the degree of compliance,
- evidence or risk of containment breach
- security issues
- emergencies plan
- post trial management
Click here for an example of an inspection worksheet: http://www.isb.vt.edu/Containment-guide.aspx, page 65, Appendix III
GuideGuide:
A Practical Guide to Containment: Plant Biosafety in Research Greenhouses – Information Systems for Biotechnology, Virginia Polytechnic Institute and State University (2001)
