The publication of the new regulations relating to agricultural remedies  on 25 August 2023 saw the introduction of good experimental  practice  (GEP) in South Africa. For many companies operating within the South African territory, the need to standardise methods and trial methodology has been a long-standing goal.

What is the history of GEP?

The history of GEP in Europe is closely tied to the need for standardised and reliable data, particularly in the realm of plant protection products (PPP). Here is a breakdown of key aspects:

Early drivers: The need for consistent and high-quality data became increasingly important as the use of PPPs grew. This was driven by the necessity to ensure the efficacy and safety of these products, and to facilitate their registration across different European countries.

Eppo’s role: A significant milestone was the publication of the first GEP standard by the European and Mediterranean Plant Protection Organization (Eppo). In 1992, EPPO published its Standard PP 1/181: Conduct and reporting of efficacy evaluation trials, including good experimental practice. This standard provided a framework for the design, conduct, and reporting of efficacy evaluation trials. South Africa  will be following the same principles from August 2025.

Standardisation and regulation: GEP aims to ensure that trials are conducted according to uniform principles, leading to high-quality and mutually recognised results among European Union member states. It addresses aspects such as personnel qualifications, equipment and facilities, trial protocols, data recording and interpretation.

The GEP standards work in conjunction with the good laboratory practice (GLP) standards but are tailored to the specific needs of field trials for agricultural remedies. It is important to understand that GLP focusses on non clinical safety studies while GEP focusses on efficacy and phytotoxicity studies. Although the two systems  are very similar, their application differs.

Current practices: Today, GEP is a crucial part of the regulatory process for PPPs in Europe. Organisations conducting efficacy trials must often be officially recognised and certified to ensure compliance with GEP standards.

The GEP guidelines are continually being refined and updated to reflect the most current scientific knowledge. In essence, the development of GEP in Europe represents an ongoing effort to ensure the reliability and comparability of experimental  data, particularly in the context of agricultural practices and plant protection.  There is a clear need to implement a similar approach in South Africa and the GEP steering committee  is proud to be pioneering this system for our conditions.

GEP in South Africa

The industry extended  an invitation to all current and potential future stakeholders affected by GEP to nominate a representative for the GEP steering committee. The committee comprises members from the South African Bioproducts Organisation (Sabo), CropLife SA, the Fertilizer Association of Southern Africa (Fertasa), Nematological Society of Southern Africa (NSSA), and Plant Science Consultants Association (PSCA).

The steering committee provides feedback on the system’s progress to industry associations – through their respective board structures via the CropLife industry liaison meeting – and reports directly to the Registrar.

The South African GEP system will operate as a fully independent  certification scheme. It will apply  to facilities conducting efficacy and phytotoxicity studies under GEP. To qualify, facilities must comply with the Eppo standard, which requires documented local and facility-specific standard operating procedures (SOPs), proof of personnel qualifications and training, as well as up-to-date equipment calibration certificates.

The purpose of such standards and heir implementation will:

•   Ensure high-quality field trial results generated in South Africa.

•   Ensure that methods for conducting trials and assessments are harmonised across various organisations and locations throughout the country.

•   Increase the reliability of results, improve quality of equipment and methods used, and ensure skills and training of the personnel responsible for conducting the research.

Looking at the various elements Standard operating procedures: These include trial-specific SOPs, relevant Eppo standards, and facility-level SOPs for the design, execution, assessment, and reporting of field trials. While Eppo standards are available, published standards are not always available for all local conditions. In such cases, the industry has appointed subject-matter experts to draft, review, and finalise local SOPs. These will be published on the South African GEP website. The SOPs aim to harmonise methodologies for site selection, pest targeting, trial implementation, assessment procedures, data generation, and reporting.

Trials: Trials are essential to assess the performance of candidate compounds under certain growing conditions, using appropriate equipment. Good experimental practice ensures methodological rigour in trial design and execution to accurately evaluate the efficacy of candidate compounds and to produce reliable reports.

Test organisation: All organisations conducting field trials must be registered and formally recognised under the GEP system. As part of the registration process, each organisation must provide its physical location, fields of expertise, and the geographical areas where trials will be conducted. The organisation conducting the tests is responsible for ensuring that GEP principles are applied throughout all stages  of the trial process – from receipt of test products to the final reporting. Audits will be conducted on key aspects such as application, residue sampling, data collection,  and reporting to verify compliance with GEP standards.

Test location: Test organisations must clearly indicate the locations of all trial sites and ensure that data is traceable to its respective site – from the trial’s initiation through to the final report.

Study management: Organisations must demonstrate the ability to manage trials in line with GEP standards. This includes having adequate personnel and resources to initiate and execute trials. Internal SOPs must outline the processes for conducting trials, using equipment, and training personnel.

Personnel, training and proficiency: Personnel must have relevant scientific and technical qualifications, formal training, and professional experience. Ongoing training in their respective  fields is also essential. The GEP system will support ongoing training for all field personnel.

Equipment: Organisations must have access to appropriate equipment for each study and ensure that personnel are trained to operate it. All equipment  must be properly serviced, calibrated, and maintained in accordance with GEP requirements  for field studies.

Facilities: Suitable infrastructure must be available. This includes secure storage facilities for equipment and test compounds, field plots, greenhouses, and administrative and data processing facilities.

Good experimental practice verification: A central body will be responsible for issuing GEP verification  and assessing compliance through audits. Audits will be conducted by qualified individuals with adequate experience and training in field efficacy and phytotoxicity studies. A draft document is being developed by the steering committee for the recruitment, training, and qualification of auditors. Verification will be conducted independently and with the highest level of integrity.

What is next?

Employees of CropLife facilitated a GEP information session following the liaison meeting held in February this year. During the session, the framework of the GEP system was presented,  along with examples of SOPs and guidance on how to draft them. All related resources and presentations were circulated to the industry on 21 February.

A dedicated website for engagement with facilities and facility managers will be launched shortly. This platform will provide access to local SOPs and other relevant documentation.

The application process for GEP accreditation began towards the end of April this year. All industry stakeholders are invited to apply. The target date for full implementation  is August this year. Let’s make it happen.