Objective of the study

Microorganisms are always present in the environment. It is useful for information on the general ecology and biological niche of the MPCA to be available and presented to explain possible routes of dispersal and to describe the time it takes for the degradation of the MPCA to match natural background levels. Also, if the MPCA is found to be not indigenous to the area it will be released, then data on the environmental fate of the MPCA is useful for considering risk.

Circumstances under which the study is recommended to be required

If the MPCA has been confirmed to produce toxicologically relevant secondary compounds (metabolites) at levels above the natural background and therefore expected to cause toxicity, then this information is recommended to be required. It is always required to provide good quality information from literature. Information specific to the MPCA, including studies done using various stages of the production/maintenance of the microorganism, may also be found useful if provided.

If the environmental compartment is not expected to be exposed to the MPCA during normal use, then the data point is not required (e.g., indoor use and persistence and mobility in soil).

Principles about reasoned cases for non-provision of studies

If the MPCA is expected to either not produce toxicologically relevant secondary compounds (metabolites) or produce these at levels in situ in quantities unlikely to cause toxicity, then a reasoned case for non-provision of a study may be presented. Depending on the use pattern proposed by the label, some points are not always required. For example, an MPCA registered solely for aquatic uses would not require information on persistence or mobility in soil.

Test organism or substrate

The entire MPCA.

Typical information to be provided by the applicant

Information provided in this section may also be found in 2.0 (Biological properties of the MPCA). Good quality literature or non-GLP studies can be submitted.

1. Persistence and mobility in soil
2. Persistence and mobility in water
3. Persistence and mobility in air

Information provided from the persistence and mobility of the MPCA in the environment can be further useful in other sections to understand risk for mammalian toxicity and ecotoxicity. E.g., information showing the diminishing levels of biopotency/MPCA in water could be part of a reasoned case to not provide aquatic ecotoxicology studies.

Typical endpoints of the study

There are typically no end points for environmental fate of microorganisms.

Testing guidelines

There are no specific testing protocols for microbials, however, the following guidelines and documents may be found useful.

• USA EPA Microbial Pesticide Test Guidelines: OPPTS 885.5200 Expression in a terrestrial environment.
• USA EPA Microbial Pesticide Test Guidelines: OPPTS 885.5300 Expression in a freshwater environment.
• USA EPA Microbial Pesticide Test Guidelines: OPPTS 885.5400 Expression in a marine or estuarine environment.
• OECD (2018), Working Document on the Risk Assessment of Secondary Metabolites of Microbial Biocontrol Agents, Series on Pesticides and Biocides, No. 98, OECD Publishing, Paris.
• SANCO/2020/12258 (2020) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances in accordance with article 77 of regulation (EC) No 1107/2009.