Contents - Faperta

Transgenic Resistance to Insects: Nature of Risk and Risk Management 437
impact of the release experiment. This may include isolation from sexually compatible
species, prevention of fl owering, use of male-sterile lines, and subsequent monitoring
protocols. Data required for risk management includes:
• Organization and the people involved;
• DNA donor, receiving species, and the transgene;
• Target environment and the conditions of release;
• Transgenic plant-environment interaction; and
• Control, monitoring, and waste treatment.
The focus of biosafety regulations needs to be on safety, quality, and effi cacy.
Management, interpretation, and utilization of information are important components
of risk assessment, and determine the effectiveness and reliability of biotechnology
(Williamson, Perrins, and Fitter, 1990). Various approaches addressing the risks are concerned
with establishing good standards of laboratory practice, effi ciency and security
of the containment facilities, and effects of modifi ed organisms on the human health and
the environment (Levin, 1988; Levin and Strauss, 1993). The risk is assessed in the form
of access, as a measure of the probability that a modifi ed organism (or the DNA inserted
in it) will be able to enter other organisms and survive, and expression, and anticipated
or known level of expression of the inserted DNA. Risk also measures damage in the
form of harm likely to be caused by exposure to the modifi ed organism.
General Information
To develop effective strategies for risk management, it is important to have information
on the institution and the people involved in development, and the people or organizations
to be responsible for fi eld testing and containment, monitoring, and waste treatment
of the transgenic event.
DNA Donor and Receiving Species
There is a need to have complete information about the donor and the species receiving the
gene. The receiving plant species forms the baseline with which the transgenic plant
should be compared. Information on the donor species indicates the type of information
needed about the transgene. Information is also needed about the vector used in the transformation,
and antibiotic or herbicide resistance genes used as markers. Finally, there
should be complete information about the transgenic plant, molecular data on the genes
inserted, stability of gene expression, and changes in allergenicity, toxicity, persistence in
particular environmental conditions, and ability to invade new habitats. The changes in
the transplant should be measured against the unmodifi ed control genotype.
Conditions of Release and the Target Environment
The risk to the target environment requires a qualitative judgment, and should be based
on a case-by-case study, depending on experience. Information about the purpose of the
release, size, design, and agronomic requirements is important for risk assessment and
risk management at the national and international levels. Ecological information about
the release site, survey of plant species growing in the target region, and the nature of