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The OECD Pesticide Registration and Re-registration Project for Biological Pesticides (microbials, pheromones and semiochemicals, and invertebrates such as insects and nematodes) helps governments work together to assess pesticide risks to man and the environment. The assessment of risks is important because it provides the basis for governments' decisions whether to approve, or "register," new biological pesticides and whether to renew the registration of old ones. By working together, governments can evaluate a biological pesticide's risks more quickly and thoroughly. This speeds up the process of approving safer new pesticides and stopping use of riskier ones.  The project has focused on writing guidance for the submission and evaluation of biological pesticide test data.

OECD Formats and Guidance for Biological Pesticide Data and Reviews

The agreed guidelines establish two formats:

• one for industry to use when making data submission (dossiers) for microbials and phermones/semiochemicals
• one for governments to use when writing their evaluation reports (monographs) for microbials and pheromones/semiochemicals

The formats do not require OECD countries to make the same regulatory decisions. Rather their purpose is to facilitate registration by minimizing duplication of effort for both industry and governments.

The Guidance for Industry Data Submissions and Guidance for Government Data Reviews ,  are designed to promote quality and consistency in the "dossiers" of data submitted by biological (microbial, pheromones and semio-chemical) pesticide producers when applying for a new registration, and the government "monographs" that review the data. Both sets of guidance specify the format to follow and level of information to include.

The OECD guidance helps to ensure that dossiers and monographs are clear and complete, and that information is easy to find. This makes it easier for governments to use each other's pesticide risk evaluations. And it enables pesticide registrants (usually producers) to submit the same dossiers to different governments.

Data Requirements and Approaches to Biological Pesticide Registration

Biological pesticides act differently from chemical pesticides, so different data are required for their registration. The work on data requirements for biological pesticides is directed by the Bio-Pesticides Steering Group, composed of representatives of OECD governments.A survey published in 1996 - Data Requirements for Registration of pesticides in OECD Member Countries: Survey Results shows what data different governments require for different types of biological pesticides. Work to harmonise the requirements is underway for three types of biological pesticides:

Micro-organisms, or Microbial Pesticides: This category of biological pesticide includes bacteria (such as Bacillus thuringiensis), algae, protozoa, viruses and fungi. Used to control pest insects, micro-organisms generally pose little or no risk to man and the environment. But they must still be tested and registered for use. The project has reviewed the data requirements in individual countries and the European Union, and written Guidance for Registration Requirements for Microbial Pesticides  (2003).

Pheromones and other Semio-chemicals:  Semio-chemicals are chemicals produced by plants and animals (and synthetic analogues of such substances) that influence the behaviour of individuals of the same or other species. Pheromones modify the behaviour of individuals of the same species. Allelochemicals modify the behaviour of individuals of a different species. Although they are chemicals, semio-chemicals are grouped with the biological pesticides because they modify the behaviour of insects rather than killing them. They are expected to pose little or no risk to man and the environment. The project has reviewed the data requirements in individual countries, and has written Guidance for Registration Requirements for Pheromones and other Semio-Chemicals Used for Arthropod Pest Control (2001) .

Invertebrate Biological Control Agents, or Macrobials: This category includes insects, mites and nematodes that are natural enemies, antagonists or competitors of a pest. The project is working to harmonize data requirements and to draft guidance for the import, study and release of invertebrate biological control agents. The project is being carried out with the United Nations Food and Agriculture Organisation (FAO), the European and Mediterranean Plant Protection Organisation (EPPO), and the North American Plant Protection Organization (NAPPO).  The finds were published in 2004 as Guidance for Information Requirements for Regulation of Invertebrates as Biological Control Agents (IBCAs) .

For more information, contact:
sylvie.poret@oecd.org