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which a definitive conclusion can be drawn
concerning import and release. We propose
to use them within certain risk categories
(low, intermediate, high risk) that will result
in a proposal to release the agent (low-risk
index), not to release the agent (high-risk
index) or to come up with additional infor-
mation (intermediate-risk index). Further, it
should be clearly stated for which region a
particular risk assessment was made (conti-
nent, part of a continent, ecoarea, country,
part of a country, etc.), because risk indices
will vary according to the region for which
they were made. It would be best to deter-
mine indices for ecoareas, because these are
rather well defined and meaningful biologi-
cal units (ecoarea: an area with similar
fauna, flora and climate and hence similar
concerns about the introduction of biological
control agents (FAO, 1999)).


Risk management

The next step of the risk-assessment process
is to discuss risk management, including
risk mitigation and risk reduction. For an
example of information needed for risk
management, we refer the reader to Cross
and Noyes (1995).


Risk/benefit analysis

The final step in making a justified environ-
mental risk analysis for a new biological con-
trol agent is to conduct a risk/benefit
analysis, which should include a compara-
tive performance of pest-management meth-
ods, particularly based on environmental
aspects. The environmental benefits of the
use of the proposed biocontrol agent should
be compared with the environmental effects
of currently used and other alternative con-
trol methods.


Discussion

Biological control has been practised for
more than 25 centuries, and ‘modern’ forms
of biological control, where exotic natural


enemies are imported and released, for more
than a century. This activity has resulted in
long-term economic and environmentally
benign solutions to severe pest, disease and
weed problems. In contrast to chemical con-
trol, the biological control of insects and
mites has not resulted in negative environ-
mental or health effects.
The recent literature on introductions of
natural enemies for insect control has not
featured the role of biological control in
extinctions. This is an important conclusion,
as thousands of intended introductions
have been made worldwide, and apparently
the biological control scientists have cor-
rectly identified which natural enemies can
be safely exported. In present-day biological
control, governments that rigidly regulate
the introduction of biological control
agents, such as those of Australia and New
Zealand, usually require that candidate
agents undergo host-range testing to ensure
that they will not become pests or threaten
desirable species. This results in a general
preference for highly specific natural ene-
mies, as was already regarded as common
sense among most biocontrol workers.
Another effect of regulation is that first
native natural enemies are evaluated as
potential biocontrol agents, a development
that we strongly support.
The topic of the implementation of a reg-
istration procedure for natural enemies is
currently hotly debated by the biocontrol
industry and regulators. The biocontrol
industry foresees lengthy, cumbersome pro-
cedures leading to high costs and thus, in
some cases, the impossibility of marketing
an interesting natural enemy because of
excessive costs. Regulators within min-
istries of environment and agriculture want
to prevent unnecessary and risky releases of
exotic organisms. The history of arthropod
biocontrol shows that very few mistakes
have been made up to now. This is a point
in favour of the biocontrol industry and is
in strong contrast to the problems that have
been created by the accidental importation
of pests and diseases on infested plant
material by others. The current work by the
EU-ERBIC project, in collaboration with an
OECD working group (OECD, 2003), will

Regulation and Risk Assessment of Biocontrol Agents 201
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