Principles of Plant Genetics and Breeding

conditions. Further, these phenotypic changes induced
by the transgene may only be minor alterations.
In view of the foregoing, it appears that the best way
to assess any adverse effect of a transgene is to directly
test for harmful outcomes. In food biotechnology, some
believe that this should include testing for both shortand
long-term human toxicity and allergenicity, among
others. There should also be an assessment of environmental
impact over time and across relevant sites. Then,
a final assessment should be made regarding the extent to
which the transgenic cultivar deviates from the parental
genotype. It is important that the analysis indicates
whether such deviations, if any, are biologically significant.
Otherwise, the GM cultivar would be substantially
equivalent to the existing cultivar and would not need
prior approval for introduction into the food chain.
However, as the transgene is derived from a source
that would not necessarily be consumed with the crop or
be present in the environment where the crop is grown,
there is a novel exposure to the transgene product. This
could provide justification for an increased assessment of
human health and environmental effects of the transgenic
crop compared with a conventionally bred crop.
Concept of the precautionary principle
The precautionary principle is an approach to handling
uncertainty in the assessment and management of
risk. This principle recommends that uncertainty, when
it exists, be handled in favor of certain values (health and
environment) over others. In other words, when our
best predictions turn out to be in error, it is better to err
on the side of safety. Another way of putting it is that, all
things being equal, it is better to have foregone the
important benefits of a technology by wrongly predicting
its risks to health or the environment, than to have
experienced harmful consequences by wrongly failing to
predict them. In statistical terms, if an error in scientific
prediction should occur, it is better to commit a Type I
error of declaring a false positive (that is, erroneously
predict an adverse effect where there is none), than a
Type II error (erroneously predict no such effect when
there actually is one). However, it is the custom of science
that it is more serious a flaw in analysis to commit a
Type I error (make a premature claim, e.g., reject the
null hypothesis that a GM crop poses no significantly
greater risk than its conventional counterpart) without
adequate scientific evidence.
In view of the foregoing, it not difficult to see why
the precautionary principle has both proponents and
ISSUES IN THE APPLICATION OF BIOTECHNOLOGY IN PLANT BREEDING 273
opponents. Proponents see it as a proactive and anticipatory
strategy for protecting the public, environment,
and animals from potential harm that is hard to predict
by even the best science available. On the other hand,
opponents view the precautionary principle as unscientific,
a tool that promotes unfounded fear in the
public and mitigates against research and development
of new technologies.
This principle emerged in the 1970s and is currently
invoked in numerous international laws, treaties, and
protocols (e.g., the Cartegena Protocol on Biosafety of
2000). It is more cautiously interpreted in Europe than
the USA. There are certain common criticisms of the
precautionary principle. Some feel it is ambiguous and
lacks uniform interpretation. Also, it marginalizes the
role of scientists in that, whenever it is invoked, it usually
tends to relax the standards of proof normally required
by the scientific community. Others see the precautionary
principle as a veiled form of trade protectionism.
Specifically, nations may invoke this principle to
circumvent the science-based decisions established in
trade agreements and enforced by the World Trade
Organization. Such rules generally require that a
nation provide reliable scientific evidence to support its
decision (e.g., to ban importation of a product). For
example, the decision by the European markets to ban
American and Canadian beef treated with rBST (growth
hormone) is considered to be colored by protectionism.
Regulation and the issue
of public trust
The public needs to trust those who develop and implement
the regulations that govern the development and
application of technologies. It is widely accepted that
even the most minimal risks may be unacceptable if
levels of public trust in those who manage these risks
are low or eroding. In Europe, the general public apprehension
about the risks of GM foods is blamed to a
large extent on the loss of public trust in scientists and
regulatory bodies resulting form the bovine spongiform
encephalopathy (BSE) crisis in Britain.
It is claimed that the assessment of biotechnology
risks is a science-based activity. Consequently, it is
important that the process be above reproach. The science
should be of high quality, and the conduct of the
assessment be independent and objective. There should
be no conflict of interest in the regulatory process. Any
association between producers and regulators is bound
to cast doubt on the integrity of the process.