ISPM 03 1995 en 1998-07-13
ISPM 03 1995 en 1998-07-13
ISPM 03 1995 en 1998-07-13
3
February 1996
© FAO 1996
CONTENTS
Endorsement 1
Review and amendment 2
Distribution 3
INTRODUCTION
SCOPE 4
REFERENCES 4
DEFINITIONS AND ABBREVIATIONS 5
OUTLINE OF THE CODE 9
Endorsement
International standards for phytosanitary measures are prepared by the Secretariat of the
International Plant Protection Convention as part of the United Nations Food and
Agriculture Organization’s global programme of policy and technical assistance in plant
quarantine. This programme makes available to FAO Members and other interested parties
these standards, guidelines and recommendations to achieve international harmonization of
phytosanitary measures, with the aim to facilitate trade and avoid the use of unjustifiable
measures as barriers to trade.
The following standard was endorsed by the 28th Session of the FAO Conference in
November 1995.
Jacques Diouf
Director-General
Food and Agriculture Organization of the United Nations
Code of conduct for the import and release of exotic biological control agents / 2
Standards will be updated and republished as necessary. Standard holders should ensure
that the current edition of this standard is being used.
Code of conduct for the import and release of exotic biological control agents / 3
Distribution
International standards for phytosanitary measures are distributed by the Secretariat of the
International Plant Protection Convention to all FAO Members, plus the
Executive/Technical Secretariats of the Regional Plant Protection Organizations:
INTRODUCTION
SCOPE
This standard describes the Code of Conduct for the Import and Release of Exotic
Biological Control Agents. It lists the responsibilities of the authorities of governments,
and the responsibilities of the exporters and importers of biological control agents.
The Code addresses the importation of exotic biological control agents capable of self-
replication (parasitoids, predators, parasites, phytophagous arthropods and pathogens) for
research and/or release into the environment including those packaged or formulated as
commercial products.
Governments that are already fulfilling the objectives of this Code by regulation or other
equivalent means may consider adapting their existing systems in the light of this Code.
REFERENCES
- Anon, 1988. New organisms in New Zealand. Procedures and legislation for the
importation of new organisms into New Zealand and the development, field testing and
release of genetically modified organisms. A discussion document. Ministry for the
Environment, Wellington, New Zealand, 59 p.
- Coulson, J.R. & Soper, R.S., 1989. Protocols for the introduction of biological control
agents in the U.S. pp. 1-35. In Plant Protection and Quarantine vol III, Special Topics.
R.P. Kahn (ed.), CRC Press, Boca Raton, Florida.
- Coulson, J.R., Soper, R.S. & Williams, D.W., 1992. Proceedings of USDA ARS
Workshop on Biological Control Quarantine: Needs and Procedures, 14-17 Jan. 1991,
Baltimore, Maryland, Washington, DC, US Department of Agriculture, Agricultural
Research Service, 336 p.
- EEC, 1991. Official Journal of the European Communities: Council Directive of 15 July
1991.
- Glossary of phytosanitary terms, 1997. ISPM Pub. No. 5, FAO, Rome.1
- Guidelines for pest risk analysis, 1996. ISPM Pub. No. 2, FAO, Rome.
- Guidelines on the registration of biological pest control agents, 1988. FAO, Rome.
- International code of conduct on the distribution and use of pesticides (Amended
version), 1990. FAO, Rome.
- International Plant Protection Convention, 1992. FAO, Rome.
- Laird, M., Lacey, L.A. & Davidson, E.W. (eds.), 1990. Safety of microbial insecticides.
CRC Press, Boca Raton, Florida, 259 p.
- Leppla, N.C. & Ashley, T.R. 1978. Facilities for insect research and production.
USDA Technical Bulletin, No. 1576, 86 p.
- Lundholm, B. & Stackerud, M. (eds.), 1980. Environmental protection and biological
forms of control of pest organisms. Swedish Natural Science Research Council, Ecological
Bulletin no. 31, 171 p.
1
The terms and definitions published in 1996 in this standard conform to this edition of the Glossary
of phytosanitary terms.
Code of conduct for the import and release of exotic biological control agents / 5
Biological control (Biocontrol) Pest control strategy making use of living natural
enemies, antagonists or competitors and other self-
replicating biotic entities.
Biological pesticide
(Biopesticide) A generic term, not specifically definable, but
generally applied to a biological control agent,
usually a pathogen, formulated and applied in a
manner similar to a chemical pesticide, and
normally used for the rapid reduction of a pest
population for short-term pest control.
Establishment (of a
biological control agent) The perpetuation, for the foreseeable future, of a
biological control agent within an area after entry.
Introduction (of a
biological control agent) The release of a biological control agent into an
ecosystem where it did not exist previously (see
also "establishment").
Quarantine (of a
biological control agent) Official confinement of biological control agents
subject to phytosanitary regulations for observation
and research, or for further inspection and/or
testing.
Code of conduct for the import and release of exotic biological control agents / 8
It is recognized that it may often be difficult to know whether the agent in a biological
pesticide is exotic or not. For that reason many biological pesticides may have to be treated
as though they were exotic.
The Code does not deal with other pest control techniques, that are also sometimes referred
to as "biological controls", notably, autocidal methods, resistant host plants, as well as
behaviour-modifying chemicals and other novel biological products. For toxic products of
microbes used as pesticides which cannot reproduce and which are similar to conventional
chemical pesticides, refer to the FAO International Code of Conduct on the Distribution
and Use of Pesticides where they are covered in detail.
Procedures governing the handling and release into the environment of strains of organisms
created artificially by genetic engineering are currently being examined by various
international organizations and by national programmes. If required this Code could be
applied to these organisms.
It is possible that this Code, after due evaluation, could also be applied to the introduction
of exotic biological agents to control pests affecting human or animal health or the
conservation of natural habitats.
- facilitate the safe import, export and release of exotic biological control
agents by introducing procedures of an internationally acceptable level for
all public and private entities involved, particularly where national
legislation to regulate their use does not exist or is inadequate;
1.2 Responsibilities are outlined for the entities which are addressed by this Code,
including governments, individually or in regional groupings; international
organizations; research institutes; industry, including producers, trade associations,
and distributors; users; and public-sector organizations such as environmental
groups, consumer groups and trade unions. All references in this Code to a
government or governments shall be deemed to apply equally to regional groupings
of governments for matters falling within their areas of competence.
Code of conduct for the import and release of exotic biological control agents / 11
2.1 Governments should designate the competent authority empowered (normally the
National Plant Protection Organization) to regulate or otherwise control and, where
appropriate, issue permits for the importation and release of biological control
agents. The authority may exercise its powers by using an internationally accepted
standard (such as this Code) for guidance or by applying national legislation (which
should be aligned with this Code). Importations of biological control agents should
only be carried out with the consent of the authority.
2.2.1 Consider the legislation and regulations for the import and release of
biological control agents.
2.2.2 Establish procedures for the assessment of the dossiers specified in section
4 and for establishing conditions appropriate to the assessed risk for the
importation of biological control agents either with confinement in
quarantine or directly to the importing agent without such requirement.
3.1.1 Endeavour to promote compliance with the Code or use specific powers or
introduce necessary legislation to regulate the import, distribution and
release of biological control agents in their countries, and make provision
for effective enforcement.
3.1.2 Evaluate the dossiers specified in section 4 on the pest and the candidate
biocontrol agent supplied by the importer in relation to the degree of
acceptable risk and establish conditions for importation, containment or
release appropriate to the assessed risk.
3.1.4 Ensure that procedures are available for the full documentation of the
importation (identity, origins), release (numbers/quantities, dates, localities),
impact of each particular biological control agent in each country and any
other data relevant to assessing the outcome, and make records are
available to the scientific community and the public, as may be appropriate,
while protecting any proprietary rights to the data.
3.1.8 Decide if after a first import, further imports of the same biological control
agent can be exempted from some or all of the requirements for import.
3.1.10 Ensure, in the case of repeat imports of a biological control agent for use in
biocontrol or as a biopesticide, that documentation of the certification
system permitting entry and release is such that only imports of at least
equivalent standard to the approved import are released.
3.1.11 Take action to inform and educate local suppliers of biological control
agents, farmers, farmer organizations, agricultural workers’ unions, and
other interested parties on the appropriate use of biological control agents.
3.1.12 Consult with authorities in neighbouring countries within the same ecoarea
and with relevant regional organizations to clarify and resolve any potential
conflicts of interest that may arise between countries.
3.2.1 Ensure that regulations of the importing country relevant to the Code are
followed in the export from their countries of biological control agents.
3.2.3 Ensure that arrangements are made for the taking and storing of voucher
specimens of the exported material.
4.1 At the first importation, the importer of biological control agents for any purpose
should prepare dossiers for submission to the authority with information on the pest
to be controlled, including:
4.1.1 Accurate identification of the target pest, its world distribution and probable
origin,
4.2 At the first importation, the importer of biological control agents for any purpose
should prepare dossiers with information on the candidate biological control agent
including:
4.2.3 An analysis of the host specificity of the biological control agent and any
potential hazards posed to non-target hosts,
4.3 At the first importation, the importer of biological control agents for any purpose
should also prepare a dossier for presentation to the authority which identifies
potential hazards analyses the risks posed thereby and proposes mitigating
procedures with respect to:
4.4 The importer of candidate biological control agents proposed for research in
quarantine only should include information on the above points, plus the:
4.5 The importer of biological control agents for import and release and use as
biological pesticides should include in the dossier specified in 4.3 above, an analysis
of the risks posed to possible non-target organisms and to the environment
generally and should detail available emergency procedures should the biological
control agent after release display unexpected adverse properties. The dossier
should also contain a report detailing laboratory tests, and/or field observations and
any other appropriate data to indicate the known or probable host range of the
candidate agent. Testing should be based on recommended procedures and
approved by the authority. These tests should relate to the candidate agent only and
different procedures should apply to any additives used in formulations of products
which contain biological control agents.
5.1 Exporters of biological pesticides and other biological control agents for inundative
release should:
5.1.1 Take all necessary steps to ensure that exported biological control agents
conform to relevant regulations of importing countries, FAO and World
Code of conduct for the import and release of exotic biological control agents / 15
5.1.2 Ensure that biological control agents used in biological pesticides and for
inundative release are evaluated for safety as provided for in section 4.3.
5.1.3 Ensure that all biological pesticides and other biological control agents for
inundative release are evaluated for safety to human health and the
environment and freedom from contaminating organisms.
5.2 The exporter of biological control agents for any purpose should ensure that:
5.3 The exporter of biological control agents for research or classical biological control
should also ensure that:
5.3.1 The import permit and all other documentation required in association with
it are available prior to dispatch of the agent.
5.3.2 Packages are properly labelled in the official language of the importing
country as to their contents and handling both in transit and on receipt in
the receiving country. The information should include instructions to
handlers and officials at the point of entry on how the package should be
treated to avoid damage to the contents and on action to be taken if the
packaging is breached. It should also indicate whether it may be opened for
customs inspection or must be sent directly into quarantine before opening.
5.3.3 Advance notice with full details of routing is provided to the receiver to
minimize delays and to alert officials at the point of entry.
Code of conduct for the import and release of exotic biological control agents / 16
6.1.1 Ensure that, where required (see section 3.1.5), all imports of classical
biological control agents for research or biological control, after completion
of import requirements at the point of entry, are taken directly to the
specified quarantine facility for inspection or other required procedure. All
dead, diseased or contaminated material, as well as extraneous material and
packaging material should be sterilized or destroyed in quarantine.
6.1.2 Ensure that biological control agents for which it is considered necessary
(see section 3.1.6) are cultured in quarantine as long as has been specified
by the authority.
6.1.3 Allow certain biological control agents to be passed directly for release
providing all conditions have been complied with and appropriate
documentary evidence is made available (see section 3). In all cases where
identification or compliance is to be checked, this should be undertaken in a
secure laboratory (i.e. a closed room with facilities for sterilizing or
autoclaving extraneous or suspect materials).
7.1.1 If not already agreed under the terms of the import permit:
Consider for approval for release following critical assessment of the
submitted dossier on the agent and the establishment of appropriate
conditions to reduce the assessed risk to an acceptable level. Assessments
should be made using the types of procedures established in the ISPM
Guidelines for pest risk analysis (e.g. to assess risks to non-target
organisms and to identify risk-mitigating procedures). This may require
information from specified additional tests.
8.1.3 Consider publication of the results of each first importation and release
programme in an international journal. Such publication should include
details of the programme and its economic and environmental impact as
soon as practicable after the release of the agent.
8.1.4 Notify the authorities when problems occur and voluntarily take corrective
action and, when requested by authorities, help to find solutions to
difficulties.
9.1 This Code should be observed through collaborative action on the part of:
governments, individually or in regional groupings; international organizations;
research institutes; industry, including producers, trade associations, and
distributors; users; and other organizations such as environmental groups,
consumer groups and trade unions.
9.2 The Code should be interpreted so that the requirements of other relevant codes or
treaties are respected.
Code of conduct for the import and release of exotic biological control agents / 18
9.3 All parties addressed by this Code should observe this Code and promote the
principles and ethics expressed, irrespective of other parties' ability to observe the
Code.
9.4 The parties involved in providing biological control agents should retain an active
interest in following their products, keeping up to date with major users and with
the occurrence of problems arising in the use of their products.
9.5 FAO Members should periodically review the relevance and effectiveness of the
Code. The Code should be considered a dynamic text which must be brought up to
date as required, taking into account technical, economic and social progress.
9.6 Authorities should monitor the observance of the Code and report on progress
made to the Director-General of FAO.
Code of conduct for the import and release of exotic biological control agents / 19
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