Minor uses, which include the majority of specialty crops, are the uses of pesticides where the potential use is not large to justify it's registration from an applicant’s perspective alone. A key driver for minor uses can be the lack of economic return to an applicant from the 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.
As 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). The document 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 for 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.
It is largely determined by one or two key factors:
Minor use classifications are used to provide 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.
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:
In 2009 two surveys were carried out:
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:
In 2014 the OECD Pesticides Programme reviewed two Standards produced by the European and Mediterranean Plant Protection Organization (EPPO) in the series “Efficacy evaluation of plant protection products” with the aim of deciding if utilisation of those standards could be advantageous for use by (non-EU) OECD member countries in facilitating the registration of minor uses. The two EPPO standards reviewed were “Principles of efficacy evaluation for minor uses” (EPPO Standard PP1/224) and “Efficacy and crop safety extrapolations for minor uses” (EPPO Standard PP1/257). The OECD determined that there would be limited value in the OECD establishing similar standards and recognised that while the documents have been developed with the EU in mind the general principles applied are in broad agreement with practices utilised throughout non-EU member countries. Further the standards note that extrapolation may be possible between different geographical zones (regions) if conditions are comparable and OECD considered the documents would have useful applicability to non-EU member countries in certain circumstances. OECD encourages member countries to use these standards in their work on minor uses. The standards can be found on the EPPO website at: http://www.eppo.int/PPPRODUCTS/minor_uses/minor_uses.htm#extrapolation
Global Minor Use Portal