To register a pesticide, regulatory authorities require dozens of complex tests and more than 150 safety studies following strict procedures and protocols.
The cost of bringing a new crop protection product to market has increased by 55 per cent since the turn of the century. Much of the increase in cost can be attributed to a rise in volume and complexity of environmental safety and toxicology data required by regulatory bodies to ensure products are safe and effective.
The generation of regulatory data continues even after product authorizations have been granted. This is due to requirements for the periodic review of authorizations, requests for post commercial monitoring data or additional data on product safety, and to changes in regulatory systems.
Guidelines on gathering and analyzing safety data have been set by the Organisation for Economic Co-operation and Development (OECD), an international, intergovernmental organization.
The OECD has established Principles of Good Laboratory Practice (GLP), a management system which ensures the uniformity, reproducibility and integrity of laboratory studies around the world.
These guidelines are adopted and written into national laws, where any transgressions can lead to criminal prosecution.
Apart from pesticides and GMOs, GLP is a practice used to assess the safety of a wide number of common chemical products including pharmaceuticals, cosmetics and food additives.
A lot of health and environmental safety information is already made public through various channels, such as the product label, product brochures or company websites and peer reviewed scientific literature. In addition, regulatory summaries are made available by government authorities.
In the EU, for example, the regulatory risk assessment and study summary for product applications is online with links to review reports and decisions. Further, the active substance registration reports containing the study summaries, risk assessment and summaries on scientific literature are published on the EFSA website.
There are similar portals in the US, Canada, Japan and elsewhere, and more information around pesticides can be found in The Pesticide Manual.
The crop protection industry invests heavily in innovation to ensure safe and sustainable products are continuously being created and made available to farmers. Certain parts of the data submitted to approve new products is considered Confidential Business Information (CBI) - this ensures the incentive to innovate is protected. CBI might include details of the manufacturing process or the personal details of researchers and scientists.
Disclosing regulatory data which qualifies as CBI could significantly harm innovation by reducing competition and undermining the policy balance between the public's interest in relevant health and environmental safety information, and competitive commercial interests achieved through the protection of regulatory data. The ultimate goal is to bring safe, effective and sustainable tools to farmers so they can grow a healthy crop.
CropLife International member companies are among the world's leading developers of crop protection solutions which enable farmers to produce food for a growing world in a safe and environmentally sustainable way. While the product authorization process is the essential assurance to farmers and consumers that crop protection products meet the highest standards for safety, efficacy and quality, the effective transparency of safety data can further enhance public confidence in the process. That’s why in March 2018 CropLife International and its member companies launched their transparency commitment to make more safety-related data publicly available.
The CropLife International member companies are among the world's leading developers of crop protection solutions which enable farmers to produce food for a growing world in a safe and environmentally sustainable way.
While the product authorization process is the essential assurance to farmers and consumers that crop protection products meet the highest standards for safety, efficacy and quality, the effective transparency of safety data submitted to regulatory agencies can further enhance public confidence and strengthen the understanding of the stringent safety standards of crop protection products, as well as enhance trust in the product authorization process.
The CropLife International member companies are committed to increased transparency of safety data in order to better engage in dialog with society to increase understanding and build trust. As a first step, CropLife International and its member companies are developing straightforward ways to enable non-commercial access to safety-relevant information.