Protocol for biological control agent applications - import, host-specificity test list and release

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Protocol for biological control agent applications - import, host-specificity test list and release

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Overview

DAFF is responsible for approval of the importation of biological control agents for the control of weeds and invertebrates under the Quarantine Act 1908. It is also responsible for approval of host-specificity test list and release of the biocontrol agent.

BA within DAFF assesses the importation of the agent and consults widely with cooperators on the host-specificity test list and release applications. Cooperators include AQIS within DAFF, DEW, CSIRO, and relevant State/Territory government departments or research organisations.

When BA recommends import, AQIS issues an import permit with conditions. When BA assesses and recommends the approval for the host specificity test list and release, AQIS issues a letter of approval.

DEW also regulates the import of live biological control agents under the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act). Biological control agents permitted by DEW to be imported are included on the list of specimens suitable for live import, which was established under the EPBC Act(the live import list). This list can be viewed on the DEW website, and has two parts. Agents listed on Part 1 do not require a permit from DEW for import or release. The agents listed on Part 2 will require a permit from DEW for import, and cannot be released without a letter of approval from DEW. To import and/or release a biological control agent that is not included on either Part 1 or Part 2 of the live import list, it is necessary to apply to DEW to amend the list to include the species in question. DEW will issue testing permits to enable host specificity testing in quarantine secure facilities prior to a decision on permitting for release. Testing permits will be issued by DEW following finalisation of terms of Reference for a risk assessment report.

The protocol below is a summary of information requirements and processing of biological control agent applications developed by DAFF in consultation with DEW. DAFF and DEW use the same application form for import of biological control agents and require similar information for release, but the completed forms need to be submitted separately to DAFF and DEW at the addresses given on the form. The information is needed to satisfy the legislative requirements of both DAFF and DEW.

The application process is summarised in a flowchart (Figure 1).

Import

[Administrative requirements|Information requirements|Processing of application]

Administrative requirements
  • Application form must be completed and a hard copy submitted to DAFF and DEW separately. DAFF accepts facsimiles. Please note that, if the species is on Part 1 of the DEW live import list, there is no need to submit the application to DEW
  • Separate import permits from DAFF and DEW when necessary
  • Application fees: check with AQIS and DEW
  • Address of AQIS-approved quarantine premise with appropriate containment level
  • When appropriate, specifying the host material or the media used for the transportation of the agent
  • Three copies of an information package about the proposed biological control agent and its target (see Information requirements below).
Information requirements

(the provision of this information will also satisfy any DEW requirements for their terms of reference for the release report):

  • Agent name (order or group, family, genus, species, author, date if possible and common name(s) if available)[1]
  • Brief biology of the agent
  • Native range and, if determinable, probable area of origin
  • Related species and a summary of their host range
  • Proposed source(s) of agent
  • When the target species was approved for biological control and the proposing organisation
  • Mode of action against target organism and extent of action
  • Potential for control of target
  • Non-target organisms at risk from agent (include those closely related biologically and those ecologically similar), including a draft host-specificity list
  • Possible interactions with existing biological control programs (of same or related targets and other targets)
  • Information on target species is to include a summary of the economic and environmental losses caused by the target and the expected benefits resulting from control of the target species
  • Copies of any references referred to in the application
  • Summary of proposed activity
  • Current status of species in Australia
  • Information and results of any other similar assessments undertaken on the species
  • Information on all other relevant Commonwealth, State and Territory legislative controls on the species.
Processing of application
  • Application will be assessed by BA and DEW independently.Note: to be assessed, the application must contain all required information
  • When BA recommends import, an AQIS import permit will be issued with conditions that minimise quarantine risk
  • A separate DEW testing permit is required for species not included on Part 1 of the live import list.

Host-Specificity Test List

[Administrative requirements|Information requirements|Processing of application]

Administrative requirements
  • Preferably, an information package is submitted through email (see Submission of Application below for detailed address). The package should be prepared following the Information requirements below
  • If the package is too big to be sent through email, twenty-one copies of the information package are required.
  • Copies of references referred to in the information package must be provided.
  • No fee is required for application for host-specificity test list.
  • No DEW requirements for the host-specificity test list. However, DEW is involved as one of the cooperators and would provide comments on the list to BA.
Information requirements

Information for target species

  • Target species name (order or group, family, genus, species, author, date if possible) and common name(s) if available
  • Native range and possible centre of origin if determinable
  • Australian and overseas distribution, including climatic information if possible
  • Native and introduced related species in the same order (family names and number of genera if there are many related species)
  • When approved as a target species, and proposing organisation
  • Details of pest status, including as much economic detail as possible (eg. costs, benefits, maps showing distribution and intensity of occurrence, etc).

Information for potential biological control agent

  • Agent name (order or group, family, genus, species, author, date if possible) and common name(s) if available
  • Brief biology of the agent
  • Native range and, if determinable, probable centre of origin
  • Related species and a summary of their host range
  • Proposed source(s) of agent
  • When the target species was approved for biological control and proposing organisation
  • Mode of action against target organism and extent of action
  • Potential for control of target
  • Non-target organisms at risk from agent (include those closely related biologically and those ecologically similar)
  • Possible interactions with existing biological control programs (of same or related targets and other targets)
  • Information on target species to include a summary of the economic and environmental losses caused by the target and the expected gains by the control of the target species
  • Details of results of host-specificity testing undertaken elsewhere if known
  • Host-specificity test list with justification, particularly why species have been excluded.
  • Methodology of testing.
Processing of application
  • When the application and the information package are received by DAFF, they will be sent by BA to all 21 cooperators for assessment, including DEW
  • Cooperators will be asked to respond within 40 working days, and all cooperators are requested to respond
  • If no response has been received by the due date, then BA will assume there is no objection to a proposed host-specificity test list
  • If any cooperator disagrees with the proposed list and wishes the list to be expanded, the applicant is required to liaise with the concerned cooperator(s) to resolve the issue(s). The Evidence that the issue(s) have been resolved must be sent to BA.
  • DAFF will normally respond to an application within 50 working days. However, approval for the application may be extended if issues between the cooperators and applicant remain unresolved
  • When BA recommends approval of the host specificity test list, AQIS will send a letter of approval to the applicant.
  • As stated above, a separate DEW testing permit is required for species not included on Part 1 of the live import list.

An existing approved host-specificity test list will be accepted for the same target species for an insect with the same mode of feeding as that of an insect for which it was originally approved. If any reduction or variation on existing lists is requested, then a full approval process will be required.

Release

[Administrative requirements|Information requirements| Processing of application]

Administrative requirements
  • Separate approvals are required from DAFF and DEW
  • A qualified AQIS regional officer such as quarantine entomologist will supervise the physical release of the agent from the quarantine facility
  • If new material of the approved agent is to be imported, an application form must be completed and a hard copy submitted to DAFF. An new import permit will then be issued by AQIS
  • Fees apply for the import of new material: check with AQIS. However, no fee is required for application for release.
  • Preferably, an information package is submitted through email (see Submission of Application below for detailed address). The package should be prepared following the Information requirements below
  • If the package is too big to be sent through email, twenty-one copies of the information package are required.
  • Copies of any references referred to in the report must be included.
Information requirements

Information on the results of host-specificity testing

Approved host-specificity test list to be included and explanations provided on any variations. If there are any variations to the approved host-specificity test list, cooperators are not obliged to accept the variations

Results of the host-specificity testing

Information on the results of host-specificity testing

  • Approved host-specificity test list to be included and explanations provided on any variations. If there are any variations to the approved host-specificity test list, cooperators are not obliged to accept the variations
  • Results of the host-specificity testing.

Information for target species

  • Target species name (order/group, family, genus, species, author, date if possible) and common name(s) if available
  • Native range and possible centre of origin, if determinable
  • Australian and overseas distribution, including climatic information if possible
  • Native and introduced related species in the same order (family names and number of genera if there are many related species)
  • When target species was approved for biological control and proposing organisation
  • Details of pest status, including as much economic detail as possible (eg. costs, benefits, maps showing distribution and intensity of occurrence, etc.), possible environmental losses caused by the target, and the expected benefits resulting from control of the target species.

Information for potential biological control agents

Agent name (order, family, genus, species, author, date if possible and common name(s) if available. Voucher specimens must be lodged with the Australian National Insect Collection or an Australian State/Territory agricultural collection or herbarium and should contain the following information:

  • reference numbers for undescribed species
  • country of origin
  • host
  • date collected
  • collection location
  • target species
  • source of identification
  • contact officer for biological control program.
Summary of agent biology and ecology, including:
  • native range (and, if determinable, possible area of origin)
  • estimate of likely or potential efficacy
  • related species and a summary of their host range
  • sources of agent.
Report of host-specificity testing, including:
  • quantified response of laboratory evaluation of oviposition, larval and adult feeding, development to maturity on each test species, fungal development etc., where appropriate
  • testing methods
  • overseas host records, including literature and discussions with experts
  • risk evaluation to non-target species
  • any evidence to reveal laboratory artefacts in behaviour or development
Possible interactions, including conflict-of-interest with existing biological control programs: (For example, if the target species is in the same genus as an introduced agent in an existing biological control program, the potential agent must be tested against the existing biological control agent.)
  • information on where, when and how initial releases will be made.

Additional information may be provided, but is not mandatory:

  • Collaborators and nature of collaboration (eg. research evaluation, assistance in mass-rearing, secondary distribution, releases, monitoring of spread and effectiveness, provision of starter colonies, etc
  • The above list is only a guide. It is recognised that, in some cases, more information will be required. For some targets and agents, not all points will need to be covered
  • Some additional information may also be required to ensure that all of the DEW terms of reference are adequately addressed.
Processing of application
  • When the application and the information package are received by DAFF, they will be sent for assessment to all 21 cooperators including DEW [2] Cooperators will be requested to respond within 40 working days and all cooperators are encouraged to respond
  • If no response has been received by the due date, then BA will assume there are no objections to a proposed release.Note footnote 2 below that DEW has a separate assessment process and an DEW letter of release is also required If any cooperators disagree with the proposed release, the applicant is required to liaise with the concerned cooperator(s) to resolve the issue(s) The Evidence that the issue(s) have been resolved must be sent to BA.
  • DAFF will normally respond to an application within 50 working days. However, approval for the application may be extended if issues between the cooperators and applicant remain unresolved
  • When BA recommends approval for release, AQIS will send a letter of release authority to the applicant.

Submission of Applications

Applications with the required supporting information package for import and for release should be sent to both DAFF and DEW at the addresses below. Application for host-specificity test list only needs to be submitted to DAFF.

Completed application form for import must be submitted by post or by fax as a signature is required.

Preferably, applications for host-specificity test list and for release be sent by email. However, if the application package is too big to be sent through email, twenty-one hard copies are required.

Application fees:Both AQIS and DEW may charge fees for issuing permit for the application for a permit to import biological control agents and the applicant is advised to check with AQIS and DEW on their fee requirements. No fees are required for the applications for host-specificity test list and for release.

Plant Programs
Animal and Plant Program Branch
Australian Quarantine and Inspection Service
Australian Government Department of Agriculture, Fisheries and Forestry
GPO Box 858
Canberra ACT 2601
Australia

Phone: (02) 6272 3288
Fax: (02) 6272 3745
Email: Plant Quarantine

Director
Trade Communications and Live Imports
Wildlife Trade and Sustainable Fisheries
Australian Government Department of the Environment and Heritage
GPO Box 787
Canberra ACT 2601
Australia

Phone: (02) 6274 2388
Fax: (02) 6274 1105
Email: wsm@environment.gov.au

Further information

Further information and technical advice can be obtained from

Plant Biosecurity
Biosecurity Australia
Australian Government Department of Agriculture, Fisheries and Forestry
GPO Box 858
CANBERRAACT2601

Tel: (02) 6272 5094
Fax: (02) 6272 3307
Email: Plant Biosecurity

Director
Trade Communications and Live Imports
Wildlife Trade and Sustainable Fisheries
Australian Government Department of Environment and Heritage
GPO Box 787
CANBERRAACT2601

Tel: (02) 6274 2388
Fax: (02) 6274 1105
Email: wsm@environment.gov.au

Suggestions or Comments on the Protocol

Please send any suggestions, comments or concerns on the protocol to Dr Ting-Kui Qin of Biosecurity Australia.

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[1] Note: If the species is undescribed or there is doubt about its taxonomy, a specimen or specimens of the most readily identifiable stage must be lodged in the Australian National Insect Collection or an Australian State/Territory agricultural collection or herbarium. Evidence that the specimens have been lodged must accompany the application or must be sent to DAFF and DEW before permits are issued. Information should include detailed specimen data (such as location, hosts, collector and identifier) and institution where lodged and voucher specimen number.

[2] Although the application will be sent to DEW, it is not necessary for DAFF to wait for DEW’s response before approving the application. This is because DEW assesses the application for release of biological control agents under the Environment Protection and Biodiversity Conservation ACT 1999, a separate process from DAFF’s. However, the AQIS letter of approval will state that AQIS approval is not valid unless accompanied by a DEW letter of approval for release. This means that sometimes the applicant may have to wait for DEW’s approval after the AQIS approval has been given.