PM 6/2 (4) Import and release of non-indigenous biological control agents

Abstract

Specific scope: This Standard provides an application form and guidelines to support an application for the import and/or release of a non-indigenous biological control agent (BCA). The Standard does not concern BCAs that are indigenous1 to the area of release. The Standard applies to invertebrate BCAs used for augmentative and/or classical biological control, and micro-organisms used for classical biological control.2

Specific approval and amendment: First version approved in 2000–09. Revision approved in 2010–09. Second revision approved in 2014–09. Third revision approved in 2024–09.

Before non-indigenous biological control agents (BCAs) are introduced into a country, an assessment of their potential risks to agricultural and natural ecosystems should be carried out. This assessment is informed by a period of research on the BCA concerned. In cases where the research is performed in the country where the BCA is intended to be released, the first import of the BCA for research should be carried out following the notification procedure of the EPPO Standard PM 6/1(2) First import of non-indigenous biological control agents for research under confined conditions (EPPO, 2023). A BCA may also be released directly following import, in cases where the required research and mass rearing have been carried out in another country, and the conclusion of the research is that BCA constitute no risk to agricultural and natural ecosystems. The present Standard is mainly concerned with the release of BCAs after research and mass rearing have been completed.

If the BCA is released for classical biological control, it is intended to establish and control one or more pests, possibly permanently. If the BCA is used for augmentative biological control, it is not intended to establish but is periodically introduced into a specific environment to suppress pest populations. For both classical and augmentative biological control, there is the potential for the BCA to cause undesirable consequences which may be irreversible, such as long-term negative impacts on non-target species. It is therefore necessary to carry out an assessment of a BCA's risk (focusing on plant health and the environment) prior to release, while taking into consideration the benefits.

ISPM 3 (Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms, IPPC, 2005) states that Governments should designate a National Authority responsible for its implementation. For the purpose of import and release of non-indigenous BCAs, the National Authority should establish an appropriate official procedure. Each country should decide what type of administrative system is appropriate (notification, approval or authorization), taking into account official policies in support of biological control and at the same time ensuring safety for agricultural and natural ecosystems.

The current Standard should be used by the applicant when compiling a dossier to support an application to release a non-indigenous BCA. The Standard provides a template of an application form and guidance for answering individual questions (see Appendix 1).

The EPPO Standard PM 6/4 Decision-support scheme for import and release of biological control agents of plant pests (EPPO, 2018) should be used by decision makers to assess the dossier.

Following receipt of the dossier, the National Authority will assess the information provided. EPPO Standard PM 6/4 Decision-support scheme for import and release of biological control agents of plant pests (EPPO, 2018) provides a framework for doing this. PM 6/4 is based on ISPM 11 (IPPC, 2013) Pest risk analysis for quarantine pests, ISPM 3 (IPPC, 2005) Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms, EPPO Standard PM 5/3 (EPPO, 2011) Decision-support scheme for quarantine pests and a previous version of EPPO Standard PM 6/2 (EPPO, 2014) Import and release of non-indigenous biological control agents. It covers the following elements of environmental impact assessment (EIA) for BCAs of plant pests: initiation, probability of BCA establishment and spread in the impact assessment area (IAA), and assessment of potential positive and negative consequences on agricultural and natural ecosystems.

The National Authority should determine whether all relevant national and international regulations have been respected. For example, whether natural resources are safeguarded (access and benefit sharing or the movement of rare or endangered organisms). The National Authority may consider organizing a stakeholder consultation as part of the evaluation process, especially in the case of classical biological control. Stakeholders may include industry bodies, conservation organizations, the public, and regulators from neighbouring countries.

The National Authority should determine if a release programme along with a post-release monitoring protocol should be submitted alongside an application for release.

After the dossier has been reviewed and consulted on, the National Authority will decide whether to grant approval for the import and/or release of the BCA. In cases where a permit is granted, the National Authority may give conditions for the import and/or release of the BCA. The authorisation can be issued for a specific duration, after which a renewal may be sought.

The procedure described in this Standard is intended to be used for the first release of a BCA in a particular country. Under certain circumstances (e.g. different strains or populations), it may be necessary to repeat the process for further releases.