OECD and Harmonization

What is the OECD?

The Organization for Economic Co-operation and Development (OECD) is an international organization of 34 countries that accept the principles of representative democracy and free market economy. It originated in 1948 as the Organization for European Economic Co-operation (OEEC) to help administer the Marshall Plan for the reconstruction of Europe after World War II.  Later, its membership was extended to non-European states, and in 1961 it was reformed into the Organization for Economic Co-operation and Development by the Convention on the Organization for Economic Co-operation and Development.

OECD describes its purpose as follows:

The OECD provides a forum in which governments can work together to share experiences and seek solutions to common problems. We work with governments to understand what drives economic, social and environmental change. We measure productivity and global flows of trade and investment. We analyze and compare data to predict future trends. We set international standards on a wide range of things, from agriculture and tax to the safety of chemicals.

 

Why is the OECD important for us?

The OECD runs a large work program on chemical safety under the Environment, Health and Safety (EHS) Programme. The corner stone of this program consists of the Test Guidelines Development Programme and the Good Laboratory Practice and Compliance monitoring. Adherence to these OECD acts is mandatory for any OECD member country. In addition the chemical safety program covers ten further areas of work, one of which is the Working Group on Pesticides (WGP).

Since 1992, the OECD Pesticide Programme has worked to streamline the process of pesticide approval and registration by helping governments work together to evaluate the risks of individual pesticides more quickly and thoroughly. It has also developed tools and approaches to reduce risks from pesticides and to evaluate progress in risk reduction, taking into account impacts caused by climate change and threats to biodiversity. The WGP has developed a new Vision for Future (2024) encompassing a global approach to the regulation of agricultural pesticides: harmonized registration and sustainable use.  CropLife fully supports this Vision for the Future and engages in many of the strategic objectives derived from this vision.

Some of OECD’s harmonization activities where CropLife participates are described below.

 

Harmonization of test guidelines and risk assessment methodologies

The OECD Test Guideline Programme (TGP) has been quite effective in developing, validating and adopting new test guidelines and adopting new test procedures that have led, in general, to global harmonization of study guidelines thereby reducing the need to repeat safety studies due to incompatible test protocols. The program has in the past been criticized for not being sufficiently efficient and the OECD has taken steps to address this concern. Recent efforts to expedite the development, validation and adoption of new guidelines have led to successes, particularly in the area of residue chemistry. Worth mentioning is the OECD MRL calculator, which is now widely used and helps achieve more harmonized MRLs globally.

It has to be realized that even with more harmonized methodology, risk assessments and risk management decisions remain the sovereign right of individual countries.  Individual country needs and expectations of what constitutes acceptable risk will vary based on their particular socio-economic situation, their tolerance for risk and their understanding of the benefits derived from a crop protection technology. Methodologies such as exposure assessment models may, with some modification, be used to derive estimates of exposure for various agronomic practices. However, the integration of exposure with hazard, any additional uncertainty factors that may be required and the evaluation of the benefits should be a country specific practice.

 

Harmonization of dossier submissions and regulatory review process

Over the past decade the WGP has developed guidance documents for pesticide registration. One of the documents provides guidance for industry when making data submission and the other addresses the formats recommended when governments write their evaluation reports (monograph). The data submission guidance is now routinely used for Joint Reviews, i.e. where the same dossier is submitted to more than one regulatory authority. Since these formats were developed some time ago they will need to be revised to ensure they continue to meet the requirements of regulators and applicants. The crop protection industry believes that focusing on the structure of dossiers, including study templates and the common assessment of key studies in order to set critical end points for risk assessment, advances regulatory science.

In 2011 WGP commissioned a subgroup to develop a harmonized system for delivering submissions electronically referred to as the Globally Harmonized Submission and Transport Standard (GHSTS). The first version of the GHSTS is now complete and has been published on the OECD website. The most important components of the GHSTS and their status (as of early 2017) are:

  1. GHSTS format specification, picklists and XSD (completed)
  2. GHSTS viewer (completed)
  3. GHSTS sample dossier (completed)
  4. GHSTS standalone builder (in development)
  5. GHSTS validator framework and validation rules (in planning)

We believe that upon completion of the GHSTS standalone builder, key regulators will be in a position to accept electronic submission in this format and applicants will increasingly use this submission format. We expect that over time the different national and regional standards for submission that are currently in use will be replaced, as GHSTS is able to work with any existing table of contents.

The following screenshot shows the eSubmission viewer with the GHSTS sample dossier, both provided by the European Crop Protection Association.

Click here for information about standards and tools for electronic submissions that are supported by the European Crop Protection Association. In a world which relies increasingly on electronic provision of data (replacing paper) and where regulators are increasingly cooperating and exchanging data and information, the value of standardized structures and formats for registration dossiers should not be underestimated. Agreed standards are prerequisite for applicants and regulators to operate efficient regulatory workflows. CropLife has contributed significantly to the development of the GHSTS and encourages the leading companies it represents to adopt and support the system.

 

Work sharing

OECD describes its ambition in the Vision for the Future as follows:

The regulatory systems for agricultural pesticides (both chemical and biological pesticides) will have been harmonized to the extent that country data reviews (hazard assessments or monographs) for new and reevaluated existing pesticides prepared in the OECD format on a national or regional basis can be used to support independent risk assessments and – where possible – regulatory decisions made in other regions or countries; the preparation of data submissions (dossiers) for pesticide active substances will be coordinated globally by industry, to the extent possible, in a way that opportunities are maximized for work sharing or mutual recognition among the regulatory authorities of OECD member countries.

Work sharing among regulatory authorities of OECD countries is already well established at a regional level (e.g. within the EU, US/CDN) and a number of companies have undertaken global Joint Reviews across several continents. Such Joint Reviews have been and continue to be important drivers of regulatory harmonization, since they regularly surface regulatory science or process issues that are in need of further harmonization.

If applied correctly, work sharing activities should help reduce the time that authorities spend on dossier evaluation and provide industry with greater predictability in regulatory decision-making as well as facilitating the earlier entry of crop protection products into the market with a broad label (including minor crops).

CropLife International strongly encourages the leading companies it represents to continue to make opportunities available for work sharing activities and in so doing support this strategic objective from the WGP vision.