Because of the lack of in-depth behav-
ioural and ecological studies concerning the
risks of mass releases of exotic natural ene-
mies, in 1998 we initiated a 4-year research
project on ‘Evaluating Environmental Risks
of Biological Control Introductions into
Europe’ (ERBIC), which is funded by the
European Union (EU) 4th Framework
Programme (Lynch et al., 2001). Within the
EU-ERBIC project, and in collaboration with
an Organization for Economic Cooperation
and Development (OECD) working group,
guidelines are being developed for harmo-
nized information requirements for the
import and release of invertebrate biological
control agents used in augmentative biologi-
cal control (van Lenteren et al., 2003).
This chapter presents a summary of the
situation concerning regulations for the
import and release of natural enemies and a
framework for risk-assessment procedures
for biological control agents.
Current Situation Concerning the Import
and Release of Exotic Natural Enemies
The potential risks of releases of exotic nat-
ural enemies have only recently received
attention outside the biological control
world, and an increasing number of coun-
tries now apply risk-assessment procedures
before a new natural enemy can be imported
or released. Currently, about 25 countries are
using some form of regulation concerning
the import of exotic biocontrol organisms,
and the implementation of regulation is
being discussed by many other countries.
Some procedures (e.g. those of Australia,
New Zealand and Hawaii; see articles in
Lockwood et al., 2001) are so strict that the
import and release of exotic natural enemies
are extremely difficult. Other countries have
no regulations at all, so any species can be
imported and released. There is a general
trend, however, towards more stringent reg-
ulatory requirements (e.g. Barratt et al.,
1999). Governmental plant-protection divi-
sions usually have the responsibility for per-
mitting the introduction of agents, but many
do not have the knowledge to make
informed decisions. Consequently, there is a
tendency for permits to be denied or delayed
or to over-regulate imports, so that research
costs for studies before introductions form
an insurmountable threshold for biological
control companies (Ravensberg, 1994). Based
on work done in the 1970s for parasitoids of
whiteflies in the 1970s and in 1980s for para-
sitoids of leafminers (which in both cases
were imported from North America), it is
estimated that costs associated with assess-
ment of risks will be in the order of
US$200,000 per natural enemy (J.C. van
Lenteren, unpublished data).
Most European countries do not demand
registration of macroorganisms such as mites,
insects and nematodes. In Switzerland,
Austria, Sweden and Hungary, it is, however,
necessary to register these kinds of natural
enemies. Switzerland has no specific admin-
istrative procedure and registration is han-
dled on a case-by-case basis. Austria and
Sweden apply regulations and, in Hungary,
official registration is required but not yet
strictly enforced. In Sweden it is no longer
economically feasible for natural enemies to
be used for control of minor pests or on lim-
ited acreage because of the high costs of reg-
istration fees (W. Ravensberg, Berkel en
Rodenrijs, 2002, personal communication).
Other European countries are discussing
the need for registration of macroorganisms.
In the EU macroorganisms are still exempt
from evaluation under the new pesticide leg-
islation (Directive 91/414/EEC). Use of non-
indigenous microorganisms is covered by
the EU registration procedure, where more
questions are asked about likely environ-
mental impacts than for indigenous organ-
isms. For macroorganisms European
countries have very different criteria to allow
importation and releases (ranging from no
criteria to rather strict criteria, including
information on possible environmental
impacts (Ravensberg, 1994)). In the UK,
Germany and Denmark, existing legislation
applies to the import of alien organisms. In
the UK, the release of non-indigenous organ-
isms is prohibited under the Wildlife and
Countryside Act and further supported by
the Plant Health Order for pest species. Non-
indigenous natural enemies have recently
been included in the ruling, and an importRegulation and Risk Assessment of Biocontrol Agents 193