Code of conduct for the import and release of exotic biological control agents
1. Objectives of the Code
1.1 The objectives of the Code are to:
- describe the shared responsibility of the many segments of society involved and the need for cooperation between importing and exporting countries so that:
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.
2. Designation of Authority Responsible
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 The authority needs to:
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.
2.2.3 Maintain appropriate communication with and advise affected parties, including, where appropriate, other authorities on:
3. Responsibilities of Authorities Prior to Import
3.1 The authority of an importing country should:
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.
3.1.3 Issue regulations and/or import permits stating conditions to be fulfilled by the exporter and importer. As appropriate, these should include the:
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.
3.1.5 If appropriate, ensure entry and where required, processing through quarantine facilities or consider where a country does not have secure quarantine facilities, the importation through an accredited intermediate quarantine station in a third country.
3.1.6 Ensure the deposition in appropriate collections of authoritatively identified voucher specimens of the pest(s) and imported biological control agent where they will be available for reference and study.
3.1.7 Consider the necessity to require culturing of imported control agents in quarantine before release. Culturing for one generation can help in ensuring purity of the culture, authoritative identification, freedom from hyperparasites and pathogens or associated pests. This is especially advisable when wild collected agents are involved.
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.
3.1.9 Maintain appropriate communication with and advise affected parties, including, where appropriate, other authorities on:
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 The authority of an exporting country, to the extent possible, should:
3.2.2 Follow, where the importing country has no or limited legislation concerning the import of biological control agents, the elements of the Code concerning the export of agents.
3.2.3 Ensure that arrangements are made for the taking and storing of voucher specimens of the exported material.
4. Responsibilities of Importer Prior to Import
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:
4.1.2 Assessment of its importance,
4.1.3 Its known, natural enemies, antagonists or competitors already present or used in the proposed release area or in other parts of the world.
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:
4.2.2 A summary of all available information on its origin, distribution, biology, natural enemies and impact in its area of distribution.
4.2.3 An analysis of the host specifity of the biological control agent and any potential hazards posed to non-target hosts.
4.2.4 Natural enemies or contaminants of the candidate agent and procedures required for their elimination from laboratory colonies including, if appropriate, procedures to accurately identify and, if necessary, eliminate from the culture the host upon which the agent was cultured.
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:
- human and animal health following introduction.
4.4 The importer of candidate biological control agents proposed for research in quarantine only should include information on the above points, plus the:
- security of quarantine (based on a description of the facilities and the qualifications of the staff).
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 nontarget 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. Responsibilities of Exporter Prior to Export
5.1 Exporters of biological pesticides and other biological control agents for inundative release should:
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:
5.2.2 Consignments, upon export, are accompanied by appropriate documentation:
- including information on the identity and recognition, safety, rearing or culture, and handling methods of the agent, and on possible contaminants, their recognition and elimination.
5.2.3 Packaging be sufficiently robust and consists of inert material secured in such a way that it can be inspected without escape of the contents. Wherever possible, organisms should be transported without their hosts (to reduce quarantine risks) and/or when they are in a dormant, inactive stage that is least likely to escape from packaging.
5.3 The exporter of biological control agents for research or classical biological control should also ensure that:
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.
6. Responsibilities of Authorities upon Import
6.1 Authorities should:
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. Responsibilities of Authorities Before and Upon Release
7.1 Authorities should:
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 Guidelines on 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.
7.1.2 Ensure full documentation of novel importations and their release programme as to identities, origins, numbers/quantity released, localities, dates, location of voucher specimens and any other data relevant to assessing the outcome, and maintenance of records of appropriate information with regard to other repeated releases of the same species.
7.1.3 Encourage the monitoring of the release of biological control agents in order to assess the impact on the target and non-target organisms.
7.1.4 Where problems (i.e. unexpected deleterious incidents) are identified, consider, and where appropriate, ensure corrective action is taken and inform all relevant interested parties.
8. Responsibilities of Importer after Import and Release
8.1 The importer should:
8.1.2 Make information relating to the safety and environmental impact of biological control agents publicly available, and maintain a free and frank exchange of information, not subject to commercial confidentiality, with exporters, authorities other importers and operators of programmes involving biocontrol agents.
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.
8.1.5 Ensure application of the provisions of Article 11 of the "International Code of Conduct on the Distribution and Use of Pesticides" with respect to the advertising of commercial preparations of biological control agents for sale to the public.
9. Observance of the Code
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.
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.
H. International standards for phytosanitary measures
1. General requirements for pest free areas (PFAS)
2. Specific requirements of different types of PFA
SECTION 3 - SURVEILLANCE
REQUIREMENTS FOR THE ESTABLISHMENT OF PEST FREE AREAS
Secretariat of the International Plant Protection Convention of the Food and Agriculture Organization of the United Nations Rome, 1995
International standards for phytosanitary measures are subject to periodic review and to amendment. The next review date for this standard is December 199-,
This standard was endorsed by the 2-th Session of the FAO Conference in November 199-.
Food and Agriculture Organization of the United Nations
Amendments to this standard will be given a consecutive number and will be dated.
Standard holders should ensure that all amendments are inserted, obsolete pages removed and the record below is completed.
International standards for phytosanitary measures are distributed by the Secretariat of the International Plant Protection Convention to the National Plant Protection Organizations of all FAO Members, plus the Executive/Technical Secretariats of the Regional Plant Protection Organizations:
This standard describes the requirements for the establishment and use of pest free areas (PFAs) as a risk management option for phytosanitary certification of plants and plant products and other regulated articles exported from the PFA or to support the scientific justification for phytosanitary measures taken by an importing country for protection of an endangered PFA.
FAO Glossary of Phytosanitary Terms, FAO Plant Protection Bulletin 38(1), 1990: 5-23. International Plant Protection Convention, 1992. FAO, Rome.
Principles of Plant Quarantine as Related to International Trade. 1995. FAO, Rome. Guidelines for Pest Risk Analysis. FAO (in preparation).
Guidelines for Survey and Monitoring Systems. FAO (in preparation).
Agreement on the Application of Sanitary and Phytosanitary Measures, 1994. World Trade Organization, Geneva.
DEFINITIONS AND ABBREVIATIONS
|An officially defined country, part of a country or all or parts of several countries.
|Survey conducted to establish the boundaries of an area considered to be infested by or free from a pest.
|Survey conducted in an area to determine if pests are present.
|International Plant Protection Convention as deposited with FAO in Rome in 1951 and as subsequently amended.
|Ongoing survey to verify the characteristics of a pest population.
|National Plant Protection Organization (NPPO)
|Official service established by a government to discharge the functions specified by the IPPC.
|Established, authorized or performed by a National Plant Protection Organization.
|Any species, strain or biotype of plant, animal, or pathogenic agent injurious to plants or plant products. (Definition subject to formal amendment of the IPPC.)
|Pest free area (PFA)
|An area in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained.
|Any legislation, regulation or official procedure having the purpose to prevent the introduction and/or spread of quarantine pests.
|Official rule to prevent the introduction and/or spread of quarantine pests, by regulating the production, movement or existence of commodities or other articles, or the normal activity of persons, and by establishing schemes for Phytosanitary certification.
|Methodical procedure to determine the characteristics of a pest population or to determine which species occur in an area.
* Term and definition not yet included in the Glossary of Phytosanitary Terms.
OUTLINE OF REQUIREMENTS
A pest free area is an area in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained.
The establishment and use of a PFA by an NPPO provides for the export of plants, plant products and other regulated articles from the country in which the area is situated (exporting country) to another country (importing country) without the need for application of additional phytosanitary measures when certain requirements are met. Thus, the pest-free status of an area may be used as the basis for the phytosanitary certification of plants, plant products and other regulated articles with respect to the stated pest(s). It also provides, as an element in pest risk assessment, the confirmation on a scientific basis of the absence of a stated pest from an area. The PFA is then an element in the justification of phytosanitary measures taken by an importing country to protect an endangered area.
Although the term "pest free areas" encompasses a whole range of types (from an entire country which is pest free to a small area which is pest free but situated in a country where that pest is prevalent), it has been found to be convenient to discuss the requirements of PFAs by defining three types:
In each of these cases, the PFA may, as appropriate, concern all or part of several countries.
Three main components or stages are considered in the establishment and subsequent maintenance of a PFA:
The nature of these components will vary according to the biology of the pest, the types and characteristics of the PFA and the level of phytosanitary security required, as based on pest risk analysis.
The methods used to achieve these components may include:
1. General requirements for pest free areas (PFAS)
1.1 Determination of a PFA
The delimitation of a PFA should be relevant to the biology of the pest concerned. This will affect the scale at which it is possible to define a PFA and the types of boundaries by which it can be delimited. In principle, PFAs should be delimited in close relation with the occurrence of the pest. In practice, however, PFAs are generally delimited by readily recognizable boundaries, considered to coincide acceptably with a pest's biological limits. These may be administrative (eg country, province or commune borders), physical features (eg rivers, seas, mountain ranges, roads) or property boundaries which are clear to all parties. For various practical reasons, it may also be decided to establish a PFA inside an area considered to be pest-free, and thus avoid the necessity for exact delimitation of the true limits of the PFA.
1.2 Establishment and maintenance of a PFA There are three main components in establishing and maintaining a PFA. These are:
The nature of these components will vary according to the:
- relevant PFA characteristics including its:
- level of phytosanitary security required as related to the assessed level of risk, according to the pest risk analysis conducted.
The International Standards for Phytosanitary Measures: Guidelines for Survey and Monitoring (in preparation) and Guidelines for Pest Risk Analysis provide further details on general surveillance and specific survey requirements.
1.2.1 Systems to establish freedom
Two general types of systems to provide data are recognized, though variations on, or combinations of the two can be used. These are:
This involves utilizing all sources of data such as NPPOs, other national and local government agencies, research institutions, universities, scientific societies (including amateur specialists), producers, consultants, museums and the general public. Information may be obtained from:
These may be detection or delimiting surveys. They are official surveys and should follow a plan which is approved by the NPPO concerned.
1.2.2 Phytosanitary measures to maintain freedom Specific measures can be used to prevent the introduction and spread of a pest including:
- routine monitoring
- extension advice to producers.
The application of phytosanitary measures to maintain pest freedom status is only justified in a PFA, or any portion of a PFA, in which ecological conditions are suitable for the pest to establish.
1.2.3 Checks to verify freedom has been maintained
In order to be able to verify the pest free status of a PFA and for purposes of internal management, the continuing pest free status should be checked after the PFA has been established and phytosanitary measures for maintenance have been put in place. The strength of the checking systems used should be related to the phytosanitary security required. These checks may include:
1.3 Documentation and review The establishment and maintenance of a PFA should be adequately documented and periodically reviewed.
Whatever the type of PFA, documentation should be available, as appropriate, on the:
It may be useful for an NPPO to send documentation about a PFA to a central information service (FAO or a Regional Plant Protection Organization), with all relevant details, so that the information can be communicated to all interested NPPOs at their request.
When a PFA requires complex measures for its establishment and maintenance to provide a high degree of phytosanitary security, an operational plan based on a bilateral agreement may be needed. Such a plan would list the specific details of activities required in the operation of the PFA including the role and responsibilities of the producers and traders of the country where the PFA is situated. The activities would be reviewed and evaluated regularly and the results could form part of the plan.
2. Specific requirements of different types of PFA
The term "pest free area" encompasses the spectrum of all types of PFA. For convenience, the requirements of PFAs are discussed by dividing them into three arbitrary types of pest free areas:
In each of these cases, the PFA may, as appropriate, concern all or part of several countries. The specific requirements for the three types of pest free areas are discussed below.
2.1. Entire country
In this instance, entire country freedom for a specific pest applies to a political entity for which an NPPO has responsibility.
Requirements may include:
Both data from general surveillance and from specific surveys are acceptable. They are different in that they may provide for different kinds or degrees of phytosanitary security.
2.1.2 Phytosanitary measures to maintain freedom These may include those listed in section 1.2.2.
2.1.3 Checks to verify freedom has been maintained These may include those listed in section 1.2.3.
2.1.4 Documentation and Review These may include those items listed in section 1 3.
2.2 Uninfested part of a country in which a limited infested area is present
In this instance, the distribution of the pest is limited to part of a country as determined by the NPPO. Official controls are applied to contain a pest population. The PFA may be all or part of the uninfested area.
Normally PFA status is based on verification from specific surveys. An official delimiting survey may be used to determine the extent of the infestation and, in addition, an official detection survey may be required in the uninfested area to verify absence of the pest.
General surveillance (see 2.1.1 above) may also, if
appropriate, be applied to the uninfested part of
a country in which a limited infested area is present.
2.2.2 Phytosanitary measures to maintain freedom
These may include those listed in section 1.2.2. With this type of PFA, phytosanitary regulations may also be required on the movement of commodities out of the infested area to the uninfested area to prevent spread of the pest as noted in 1.2.2.
2.2.3 Checks to verify freedom has been maintained
These may include those listed in section 1.2.3.
Monitoring surveys are of more significance in this
type of PFA than for that involving an entire country.
2.2.4 Documentation and review Documentation may include supporting evidence describing official controls such as survey results, phytosanitary regulations and information on the NPPO as noted in section 1.3.
2.3 Uninfested part of a country situated within a generally infested area
This type of PFA is an area, within a generally infested area, which has been made (or shown to be) free from a specific pest. It is maintained pest free so that an exporting country can use this status as a basis for phytosanitary certification of plants and/or plant products.
In certain cases, a PFA may be established within an area whose infestation status has not been based on specific surveys.
The PFA should be adequately isolated in relation to the biology of the pest.
Requirements should include:
2.3.2 Phytosanitary measures to maintain freedom
These may include those listed in section 1.2.2. With this type of PFA, phytosanitary regulations may also be required on the movement of host material out of the infested area to the uninfested area to prevent spread of the pest as noted in 1.2.2.
2.3.3 Checks to verify freedom has been maintained
These may include those listed in section 1.2.3. Ongoing monitoring surveys are a likely requirement with this type of PFA.
2.3.4 Documentation and review
Documentation may include supporting evidence describing official controls such as survey results, phytosanitary regulations and information on the NPPO as noted in section 1.3. As this type of PFA is likely to involve an agreement between trade partners, its implementation would need to be reviewed and evaluated by the NPPO of the importing country.