OECD releases guidance and surveys regarding minor use pesticide registration incentives

The Organization for Economic Cooperation and Development (OECD) recently released three documents on pesticide minor uses: (1) Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses (Minor Use Guidance); (2) OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results; and (3) OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses: Survey Results. The documents are available online.

Although these surveys were conducted in 2009, the results were only released in July 2011. The Minor Use Guidance summarizes the results from the two surveys conducted by OECD and is intended to provide guidance to national regulatory authorities on how to provide greater incentives to encourage applicants (manufacturers/registrants) to register agricultural pesticides (including both synthetically and naturally derived products) for minor uses. OECD reports that the countries that participated in the survey 'noted that the implementation of regulatory incentives have been in direct recognition for a strong need to have mechanisms that enhance, facilitate and encourage the registration of minor uses.' The two main areas that the OECD surveys identified as regulatory incentives already provided or expected to be provided within OECD member countries relate to extensions in data protection and waivers or reductions of fees. With regard to fee waivers or reductions, the OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results reports that most (11 or 15) of the member countries that participated in the survey have waivers or reductions as an economic incentive for pesticide minor use registrations. With regard to data protection, the member countries that participated in the surveys noted that while extended data protection may not be currently available, when the new European Commission regulations for biocides (i.e., pesticides) are in place, these countries expect to have provisions extending by three years protection for data supporting minor use registrations.

Areas of potential incentives discussed in the Minor Use Guidance and surveys to be explored include a 'fast track' registration review for minor uses, data waivers to be provided for minor use registrations, greater flexibility in allowing 'mutually acceptable data (perhaps data from another country) or through the use of data extrapolations (or crop and pest groupings),' and the development or expansion of government-funded programs for minor uses (e.g., IR-4). The OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses: Survey Results, for example, indicates it is possible to exchange data and reviews to support registrations across jurisdictions. Specifically, the report states: 'Based on the results of the survey, it appears possible to exchange data and reviews to support the registration of minor uses across jurisdictions. The amount and type of data required are similar enough to support or at least facilitate minor use registration across jurisdictions.' To enhance data sharing opportunities, the OECD survey includes recommendations for European Union countries to develop efficacy and residue data requirements and guidelines for minor uses that are harmonized with other countries and to examine expanding information data sharing agreements and consideration of foreign data and reviews across all OECD member countries.

The Minor Use Guidance concludes with a recommendation for regulators and industry to continue to 'progress and maintain dialogue and information exchange on the successful implementation of regulatory incentives, and in doing so continually... review existing incentives, explore improvements in existing incentives and opportunities for new incentives.' The Guidance also states as one of the 'conclusions/key objectives':

Whilst a number of commonly accepted approaches are utilised in several countries, such as data protection, fee waivers and data extrapolation, these alone may not provide sufficient incentive for the registration of minor uses. Countries should also consider developing new and/or complementary approaches to raise the 'value' a registrant may associate from the registration of minor uses. For example many countries have or are considering the establishment of national programmes that work directly with affected producers to prioritise needs, generate data and make regulatory submissions. In addition to the establishment of these programmes it is recognised that complementary regulatory incentives can enhance the registration of minor uses from those programmes/schemes. Where a registrant may still not associate economic value with a minor use to justify registration, countries should have in place regulatory mechanisms that allow for third party and/or temporary authorisations to be considered and where the liability from such uses are clearly outlined.