What are minor uses?
Minor uses, including the majority of specialty crops, are the uses of pesticides where the potential use is on a scale not sufficiently large to justify registration of that use from an applicant’s perspective alone, i.e. the key driver for minor uses is a lack of economic return to an applicant from registration of those uses, in particular the associated costs of generating the data required for obtaining and maintaining regulatory approval and potential liability from those uses once approved.
Typically minor uses involve crops grown on a small scale (minor crops) and often are high value specialty crops. Additionally minor uses can involve uses within major crops in terms of controlling minor pests and diseases. This results in a situation where specialty crop industries are either without or are lacking sufficient access to pest control products to adequately protect those crops. The major factor hindering the regulatory approval of minor uses is a lack of data that is largely attributable to a lack of funding required to generate data.
Although there is no internationally accepted definition for minor uses, they are therefore quite often defined as:
In 2009, the OECD published a Guidance Document on Defining Minor Uses of Pesticides (Series on Pesticides No. 49) that provides guidance on defining minor uses of pesticides at local or regional levels with the aim of enhancing the consistency between countries in the methods used in defining minor uses. It is limited to guidance for defining minor uses of pesticides only and does not provide an OECD definition. It states that “Minor use definitions serve as an important mechanism to ensuring that minor uses that are required by agricultural producers are appropriately regulated and where applicable include mechanisms that reduce the regulatory burden and are complemented by providing regulatory incentives to enhance their registration.” As there is no one internationally or OECD accepted definition for minor uses, the criteria and guidelines for determining what constitutes a minor use varies amongst member countries, although it is largely determined by one or two key factors, either area or tonnage of production and/or dietary intake. Minor use classifications are utilised to provide things such as guidance on the number of trials required, incentives to encourage their registration (i.e. reduced assessment fees/timeframes) and qualification under grower requested registration or off-label schemes.
How does the OECD facilitate minor use registration?
Since 2007, the OECD Pesticides Programme has been developing tools to facilitate minor use registration and examining mechanisms associated with minor uses in the areas of cooperation, technical and policy. Consistent with the OECD's 'Vision for the Future: a global approach to the regulation of agricultural pesticides,' and through the co-operation of OECD member countries working with relevant stakeholders, the OECD facilitates:
- mechanisms that enable international co-operation on minor use including work-sharing;
- technical guidance on preparation of data submissions for minor use;
- minimising barriers to approval of safe minor uses.
In 2009, it carried out two surveys on:
- Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses. The survey results are available here.
- Regulatory Incentives for the Registration of Pesticide Minor Uses. The survey results are available here.
Following the latter survey, a Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses was published. It provides guidance to national regulatory authorities in providing greater incentives to encourage applicants (manufacturers/registrants) to register agricultural pesticides (including both synthetically and naturally derived products) for minor uses. It lists existing regulatory incentives available in a number of countries and suggests additional possible new incentives that could be explored to encourage the registration of specialty crop or minor use needs. It discusses the various different aspects of incentives that are typically utilised including:
- Economic incentives (or increased “value”) for registrants: Data protection; Expedited reviews; and Fee reductions or waivers;
- Technical arrangements based on sound science: Extrapolation and mutually accepted data; and Number of trials;
- Authorisation process arrangements: Third party registrations; and Temporary approvals (off-label & emergency schemes);
- Research: Data generation assisted schemes;
- Promotion of safer alternatives: Reduced risk incentives; and
- Liability: Liability waivers/disclaimers.
Currently, the OECD is examining:
- Processes to address & solve minor uses;
- Global Joint Reviews – maximising outcomes & opportunities for minor uses from GJRs; and
- Efficacy & Crop Safety – exchange and use of international data for minor uses.
Minor Use Publications
Global Minor Use Portal