The OECD Pesticide Registration and Re-registration Project helps governments work together to assess chemical 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 chemical pesticides and whether to renew the registration of old ones. By working together, governments can evaluate a chemical pesticide's risks more quickly and thoroughly. This speeds up the process of approving safer new pesticides and stopping use of riskier ones.
The initial driving force for this work was a workshop held in 1992 (Washington) that developed a number of recommendations for future activities and concluded that a primary goal for OECD should be the sharing of national review reports. This was followed by a pilot project to compare country reviews of seven pesticides to determine the extent to which countries might share the burden of pesticide data review by using each other’s data review reports. Based on this work, and a subsequent workshop held in 1994 (Bilthoven) that recommended the establishment of a mechanism for ad hoc exchange of reports (i.e. development of harmonized structures and content for data submissions and data review reports), the Pesticide Programme has focused on:
Work on these objectives has progressed to the point that OECD countries have adopted a vision that by the end of 2014, governments will routinely accept “dossiers ” prepared by stakeholders in the OECD format; will routinely exchange "monographs" (containing reviews of the data submitted; and will use OECD "monographs" as a basis for independent risk assessments and regulatory decisions for new and existing pesticides.
Click here for information on Biological Pesticide Registration.
Industry Reporting and Government Review Formats
The OECD has agreed guidance concerning two formats to be used throughout member countries:
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, revised in March 2001, are designed to promote quality and consistency in the "dossiers" of data submitted by 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.The two guidance documents were developed over several years, drawing on chemical pesticide reviews previously written by individual OECD countries. In the past, pesticide data submissions and reviews were written in many different ways.
Government registration requirements and approaches
Data requirements are the data pesticide producers must provide when seeking to register a new pesticide. These data are intended to show a pesticide's intrinsic properties, potential hazards to man and the environment, and the likelihood of exposure. The data also show how the pesticide will be used, how effective it is in controlling the target pest (be this an insect, disease, or weed), and the "mode of action" or means by which it kills or controls the pest. The data are submitted to governments, which use them to assess the pesticide's risks and benefits, and to decide whether or not to approve the registration. Harmonising data requirements throughout the OECD is important because it makes it easier for governments to work together in evaluating pesticide risks.
As determined in a survey published in 1994 - Data Requirements for Pesticide Registration in OECD Member Countries: Survey Results - data requirements for the registration of chemical pesticides are largely harmonised within the OECD. The survey showed that most OECD governments require the same or similar data on pesticide:
identity (of the active ingredient as well as any inert ingredients in the pesticide product formulation)
function, mode of action and handling
manufacturing, quality control and analytical methods (to detect residues in food or water)
residues (the quantity and characteristics of residues likely to occur in food)
efficacy (in controlling the target pest)
toxicity (to man)
ecotoxicity (to wildlife and beneficial insects)
fate and behaviour in the environment.
Electronic Tools and Techniques
While OECD Member countries and other stakeholders have worked through the separate OECD programmes (new and existing industrial chemicals, agricultural pesticides and biocides) on the development and use of electronic tools for data submission and regulatory purposes, communication among them has been limited. Given the similarity of functions performed in the programmes related to data submission and evaluation, monograph production and archiving of dossier documents, a workshop was held to consider opportunities for harmonisation of the electronic tools used. The report of the OECD Workshop on Electronic Tools for Data Submission
, held in Ottawa, Canada on 2-4 October 2002, documents government approaches and recommendations for OECD work in this area.
As part of the work recommended, OECD Member countries and other stakeholders investigated and developed a standardized set of technical specifications used to assemble electronic files for any pesticide package in a predefined manner taking into account harmonisation with other existing electronic standards for pesticide submissions. This common method of electronic submission – the Global Harmonised Submission Transport Standard
(GHSTS) - was published in May 2014.
Best Management Practices
In 1999, OECD conducted a survey of member countries to collect information on best management practices among regulatory agencies. The results of this survey document the activities governments carry out in the regulatory decision process as well as any obligations under law, fees charged and time-frames established for the activities; innovative, successful approaches employed in their countries to improve the efficiency of the regulatory process; best practices that have led to the largest gains in efficiency in their countries; and finally, details on specific services for which fees are charged as well as the reasons for charging fees.
Links to Government Web Sites on Reviews
This page provides Links to web sites of OECD Governments and relevant international organisations that contain information on pesticide reviews. The page currently includes links to pages from twenty countries, the European Commission, and the Joint Meeting on Pesticide Residues (JMPR).
Links to national re-review progammes
This page gives access to the links to national regulatory authority pesticide reassessment web pages (substances currently under review and completed re-evaluations of substances). Re-reviews are carried-out to reconsider potential risks of pesticides. They may be initiated when new research or evidence has raised concerns about the use or safety of a particular pesticide or at regular intervals after the first registration.
For more information, contact: