المملكة: "Prevent" Adopts 7 basic requirements for the import of biological organisms into the Kingdom… and bans genetically modified organisms

The National Center for the Prevention and Control of Plant Pests and Animal Diseases has adopted a guide to registering biological enemies, with the aim of regulating the import, production and use of biological enemies in the Kingdom of Saudi Arabia.

The guide stipulates that the Plant Health The Center is the authority responsible for issuing permits and permits for the import of biological enemies, and this is based on the opinion of the relevant technical committee. The duration of permits or permits is set at one year, with the possibility of renewing them in accordance with regulatory procedures.

Prior approval and file management

The guide stresses the necessity of prior approval from the center for each Operations to import, produce, or use biological enemies, while reserving the Center’s right to withdraw the license immediately upon the parties’ non-compliance with the specified standards and conditions. The Center also updates the list of biological enemies permitted to be imported or produced, to be a reference for government and private entities in the Kingdom.

The Center’s role includes implementing the decisions issued by the Technical Committee, managing all files related to the registration, import, and propagation of biological enemies, and issuing permits and approvals after meeting the technical requirements. The Center is also responsible for monitoring the biological enemies upon import. Export, production and release to ensure compliance with the standards stipulated in the guide.

The committee consists of highly qualified members in the fields of plant protection And biological control, in addition to specialists in the environment and biodiversity, headed by the center.
The committee is responsible for studying and evaluating technical files, making decisions regarding the registration of biological enemies, evaluating the results of bioefficiency experiments, contributing to the preparation and updating of relevant regulations, and deciding on challenges related to the environmental use of these organisms.

Steps for registering biological enemies

The registration process begins with the submission of the application by the interested party to the center, where the phytosanitary sector refers the file to the committee to study the data and confirm From the completion of the documents, the committee sets a period of one week to complete any missing files. If they are not completed, the application is rejected and the applicant is officially notified.

The evaluation of the application includes experiments on the bio-efficiency of new biological enemies, to determine their effectiveness and ability to combat the targeted pest without affecting other environmental systems. After that, the committee takes its decision regarding registering the biological enemy or rejecting it, and the center issues the final decision and adds it to the updated positive list, while notifying the applicant.

Import conditions

Required Evidence that the imported biological enemies are already present in the local environment or included in the positive list approved by the center, and it is prohibited to import or produce any genetically modified organism.

All import requests must be accompanied by administrative and technical files that include detailed information about the targeted pest, the biological enemy, the potential risks to biodiversity, human and animal health, and any potential damage to ecosystems. The files also specify whether the biological enemy is imported for the first time or is included in the positive list, with the exception of import applications included in the positive list from an evaluation study. Risks.

Producing and multiplying biological agents

The guide allows companies, government and private production units, research centers and universities to produce only permitted biological agents, provided that they adhere to strict quality standards to ensure products free of contaminants.

Storage and transportation conditions must be adhered to, so that the biological agents are safely packed according to the type and phase of release, with a serial number placed on the product that includes its type, production date, batch number, expiration date, and the producing company.

Producers’ responsibilities include following up on field release operations to assess the biological efficacy of the pathogen, ensuring that it does not affect non-target pests, and providing technical support to farmers or beneficiaries.

The guide requires the availability of specialized facilities, such as greenhouses, air-conditioned rooms, and laboratories to monitor the quality of the pathogen, in addition to the scientific and technical expertise necessary to breed and propagate these organisms.

Risk assessment and safety assurance

The center and the technical committee are responsible for verifying the validity and accuracy of the data. provided in the registration files, ensuring their completeness and quality, including previous licenses in other countries, and the compatibility of the data with the intended use. The committee also assesses potential risks to public health, the environment, and biodiversity, including the safety of people working in laboratories, production, and the field.

The committee has the right to request additional data or impose restrictive measures if it deems there are potential risks, including conducting bio-efficiency tests and environmental assessment before issuing any import permit or trial launch.

Exceptions for scientific research

The guide allows universities and research centers to import introduced biological enemies for the purposes of scientific research only, under strict conditions that include the use of sites Stone or greenhouses, and to ensure that the organisms do not affect biological diversity or human and animal health.

Accurate data must be provided about the nature of the biological enemy, the target pest, and its natural enemies in the original habitat, and the necessary isolation and agricultural quarantine measures must be applied to maintain the safety of the local environment.

This guide confirms the Kingdom of Saudi Arabia’s commitment to regulating the use of biological enemies in a safe and effective manner, ensuring crop protection, enhancing agricultural sustainability, preserving biological diversity, and achieving a balance between biological pest control and the requirements of the local environment and public health.

The annex stresses that the import of exotic organisms designated exclusively for scientific research is subject to strict measures in accordance with the Agricultural Quarantine Law of the Gulf Cooperation Council countries and its executive regulations.

The biological organism remains under the supervision of the Prevention Center, with research bodies obligated to periodically inform the Center of the results of experiments and any changes that may occur in the condition of these organisms.

The Center monitors and evaluates the efficiency of biological enemies laboratory and field in quarantined sites, while assessing the risks. And safety factors before allowing them to be used in open fields, with the applicant bearing financial responsibility for all costs of agricultural quarantine and biological experiments.

Time frames for processing applications

Article Five and the Annex stipulate that processing applications for the import of biological enemies begins from the date of receipt of the complete technical file, and takes one month for local or invasive biological enemies that have previously been licensed, and four months for invasive biological enemies not previously registered in the Kingdom, with the possibility of requesting an extension of an additional four months only once when Need.

Production and quality control

All licensed companies and production units are subject to the center’s control to ensure the quality and efficiency of the biological agents produced, with the possibility of raising samples to verify the origin of the species and its biological characteristics.

This includes granting permits for mass production for export, on the condition of adhering to international standards, providing the required scientific expertise, and taking into account the conditions of the importing country.

Export is prohibited except for the biological agents approved by the committee and after the center’s approval, with an official application submitted before 48 hours from the date of shipment, and the possibility of requesting the examination of samples to ensure their compliance with biological and health standards.

Import control and inspection

Shipping of vital enemies upon arrival at the ports are subject to strict control by accredited agricultural quarantine inspectors, in accordance with the international standard for phytosanitary measures. The accuracy of the accompanying documents must be verified, and complete data on identity, breeding method, storage method and safety standards must be provided, with the obligation to return or destroy any shipment that does not meet the conditions at our expense. The importer.

The importer is obligated to follow up on the release of biological agents to evaluate their impact on target and non-target organisms, provide technical training to its agents and distributors, publish environmental safety data, and inform the center of any changes that may affect the risk assessment.

Monitoring the field release

Biological agents are released in appropriate climatic conditions, and can be stored in refrigerators for a period not exceeding 72 hours before re-release. The release is carried out according to specific strategies: inoculation or supplementation of biological enemies already present in the local environment, and inundation to intensively control target pests.

Doses, periods and distances between release points are determined based on the characteristics of each type of biological enemies, the target pests, and the economic importance of agricultural crops. The center supervises the assessment of the impact of biological enemies on target and non-target pests and on local biodiversity.

Regulation of microorganisms

The registration of products containing microorganisms is based on the standard requirements for chemical pesticides, taking into account that the level of risk for these products is relatively low, which allows an appropriate data summary to be sufficient in some cases.

Entities requesting registration must submit a comprehensive file containing data on the identity, production and characteristics of the microorganism, and information about its ability to cause disease or its effect on humans and animals. And data on secondary compounds and metabolic products and their impact on the environment, and the results of bio-efficiency experiments in the laboratory, growth rooms, or in small field experiments.

Preparations of introduced microorganisms are subject to bio-efficiency experiments for at least three consecutive seasons, while the settlement is subject to experiments for two consecutive seasons, to ensure their effectiveness and environmental safety before they are registered or traded in the Kingdom, and the same import, manufacturing, and trading procedures applied to chemical pesticides are applied to these products.

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