
EPPO Standards

SAFE USE OF BIOLOGICAL CONTROL
IMPORT AND RELEASE OF EXOTIC BIOLOGICAL
CONTROL AGENTS
PM 6/2(1) English
oepp
eppo
European and Mediterranean Plant Protection Organization
1, rue Le Nôtre, 75016 Paris, France
1
APPROVAL
EPPO Standards are approved by EPPO Council. The date of approval appears in each individual standard.
In the terms of Article II of the IPPC, EPPO Standards are Regional Standards for the members of EPPO.
REVIEW
EPPO Standards are subject to periodic review and amendment. The next review date for this set of EPPO
Standards is decided by the EPPO Working Party on Phytosanitary Regulations.
AMENDMENT RECORD
Amendments will be issued as necessary, numbered and dated. The dates of amendment appear in each
individual standard (as appropriate).
DISTRIBUTION
EPPO Standards are distributed by the EPPO Secretariat to all EPPO member governments. Copies are
available to any interested person under particular conditions upon request to the EPPO Secretariat.
SCOPE
The EPPO Standards on the safe use of biological control are intended to be used by NPPOs or equivalent
authorities, in their capacity as bodies responsible for overseeing and, if appropriate, regulating the
introduction and use of biological control agents.
REFERENCES
IPPC (1995) Code of Conduct for the Import and Release of Exotic Biological Control Agents. ISPM no. 3.
IPPC Secretariat, FAO, Rome (IT).
OUTLINE OF REQUIREMENTS
NPPOs of the EPPO region generally promote the use of biological control in plant protection because, like
other aspects of integrated pest management, it reduces risks to human health and the environment. Use of
biological control agents may, nevertheless, present some risks, in particular for the environment if exotic
agents are introduced from other continents, and for the user if agents are formulated as plant protection
products. In general, the latter case can be covered by EPPO Standards of series PP, concerning plant
protection products. The aim of the EPPO Standards on the safe use of biological control is to provide the
NPPOs with guidelines for assessing and reducing the risks associated with various aspects of the
introduction and use of biological control agents and, as appropriate, for comparing them with the benefits in
terms of efficacy. The EPPO Standards seek to make the administrative framework for the introduction and
use of biological control agents as light as practically possible, in order to sustain a general policy of
promotion of biological control.
2
EUROPEAN AND MEDITERRANEAN PLANT PROTECTION ORGANIZATION
ORGANISATION EUROPEENNE ET MEDITERRANEENNE POUR LA PROTECTION DES PLANTES
PM 6/2(1) English
Safe use of biological control
IMPORT AND RELEASE OF EXOTIC BIOLOGICAL CONTROL AGENTS
Specific scope
Specific approval and amendment
This standard gives guidelines for the import and release of First approved in September 2000.
exotic biological control agents.
______________________________
Introduction
seasonal establishment, it will be released on an
experimental scale first, then repeatedly at full scale 2
and the risks arising from this release should be
estimated according to this Standard. The relevant
precautions apply whatever the scale of the first
release, as undesirable consequences may be
irreversible.
The ISPM Code of Conduct for the Import and Release
of Exotic Biological Control Agents (IPPC, 1995)
serves as the model for this. It provides that
Governments should designate a National Authority
responsible for implementation. For the purpose of
import and release of exotic biological control agents,
this National Authority should institute an appropriate
official procedure. Each country should decide what
type of administrative system is appropriate
(notification, approval, authorization), taking into
account official policies in support of biological
control.
Exotic1 organisms, including biological control agents,
may pose risks to agricultural and natural ecosystems if
they establish in the environment. Their introduction
into countries should be done with great care after
assessment of the risks. The release ("intentional
liberation into the environment"; IPPC, 1995) of an
exotic biological control agent often follows a period in
which relevant research has been carried out. The first
import, for research, should then have been carried out
following the notification procedure of EPPO Standard
PM 6/1 (first import of exotic biological control agents
for research under contained conditions), and the
research will have provided information in support of
the safety and efficacy of the organism when it is in
due course released. This guideline is mainly
concerned, therefore, with the release of biological
control agents after a period of research, either in the
importing country, or in another country, provided the
EPPO-recommended notification procedure has been
respected by the importer.
The above sequence is not, however, always followed,
and biological control agents are sometimes imported
directly for release. They may have been mass-reared
in another country and then imported. In that case,
provided the mass rearing was carried out to fulfil
IOBC or equivalent quality control standards, the
notification procedure of EPPO Standard PM 6/1 may
be used by the importer. Alternatively, if they have not
been reared to fulfil IOBC or equivalent quality control
standards, or in particular if they have been collected in
the wild, the import should not only be notified by the
procedure of EPPO Standard PM 6/1 but the organisms
should be held in quarantine in order to verify their
identity and eliminate contaminants and hyperparasites.
The requirements for release of a biological control
agent are more severe than for first import for research
purposes. If the organism is to be released for classical
biological control, it is intended to establish itself and
control one or more pests, possibly permanently. If it is
intended to be used for inundative release or for
1
Preparation of dossier
Import
If the organism is to be imported for mass-rearing or
research before release, the notification procedures of
EPPO Standard PM 6/1 should first be followed. This
specifies, in brief, details on the name and address of
the organization concerned, the purpose of the
research, the containment facilities proposed for the
research, accurate identification of the agent, details on
the proposed import, etc. For full details, see the EPPO
Standard concerned, which also outlines general
safeguards.
Release
If the organism has already been imported and is
currently being held in containment, or if the organism
2
The term "exotic" excludes organisms which are
indigenous to the importing county, or which have been
introduced and have established there.
3
However, it should be noted that, for microorganisms,
regular use of a marketed product is covered in many EPPO
countries by the registration requirements for plant
protection products, and so not by this Standard. This
applies particularly to the EU Member States (through EU
Directive 91/414).
is being imported directly for release, the organization
should prepare a dossier for submission to the National
Authority. It should include:
1 the name and address of the organization
concerned, and the name of a contact person;
2 information on origin, distribution, biology, host
range, natural enemies, physical requirements for
establishment, contaminants, impact in area of
distribution, previous use in biological control;
3 the exact objectives of the release (which pests to
control, on which crops, under what circumstances,
etc.) and the potential benefits;
4 information on release of the organism earlier or
elsewhere, by whom and with what results;
5 if not already provided for import, accurate
identification of the agent or, if it has not been
identified, suitable characterization to allow its
unambiguous recognition;
6 if not already provided for import, the ultimate
origin and immediate source of the organism;
7 quantity and state/form in which the agent is to be
released;
8 finally, a risk assessment according to the EPPO
Standard PM 6 concerned (in preparation), taking
into account the points under 2 above to estimate
the possible environmental impact in the new area.
Any possible risks to animal and human health
should also be identified.
4 authoritatively identified voucher specimens of the
pests and natural enemies involved should be
deposited in appropriate collections, where they
should be available for reference and study;
5 any problems encountered in post-release
monitoring should be reported.
The procedure described in this Standard is intended to
be used for first release of an organism. Under certain
circumstances, it may be necessary to repeat it for later
releases.
General safeguards
1 any relevant information on undesirable side effects
should be reported to the National Authority.
2 biodiversity conventions and intellectual property
rights should be respected.
Evaluation of the dossier
The National Authority should examine the dossier,
evaluate its content and analyse the safety of the
release. It may request more information and additional
tests may be specified. All relevant national and
international regulations (for example on the safeguard
of natural resources or the movement of rare or
endangered organisms) should be respected. The
National Authority may propose precautions or
restrictions in the manner of release, or may
recommend that the organism should not be imported
or released.
Supervision of the release
The organization undertaking the release proceeds
under the appropriate supervision of the National
Authority, taking account of the following:
1 all appropriate safety procedures should be put in
place. In particular, all contaminants and
hyperparasites should be absent;
2 the release programme should be fully documented
as to identity, origin, numbers/quantity released,
dates, localities and any other data relevant to
assessing the outcome;
3 evaluation of the releases should be planned in
advance, to assess the impact of the organism on
the target pest and non-target organisms;
4