FAO regulations have important guiding significance for pesticide manufacturers and distributors in the production, registration and distribution. Government authorities formulate their own pesticide registration regulations with reference to the requirements and procedures established by FAO.
Therefore, from now on, we learn about some FAO specifications based on the document “FAO and WHO Manual on the Development and Use of Pesticide Specifications, 1st – 3rd Edition”.
The following information is excerpted from the above-mentioned documentation.
Scope of specifications
The term “pesticide” is deemed to include active ingredients in any form, regardless of whether or to what extent they have been formulated for application. The term is usually associated with materials (insecticides, fungicides, herbicides, etc.) used to kill or control pests.
But for present purposes, pesticide also include certain materials used to modify the behaviour or physiology of pests (e.g. repellents and synergists) or materials used to modify the behaviour or physiology of crops during production or storage (herbicides safener, germination inhibitor).
FAO and WHO specifications only apply to products from manufacturers whose technical materials have been assessed as satisfactory by their own Joint Meeting of Pesticide Specifications. Corresponding products from other manufacturers must be evaluated by JMPS to ensure that existing FAO/WHO specifications apply to them.
The specifications include the physical appearance of the material, its content of active ingredients and any relevant impurities, its physical and chemical properties, and its stability in storage.
The specification does not cover the chemical properties of formulations unless they affect physical properties (including properties such as pH, acidity and alkalinity). The instructions do not include clauses specifying the essential properties of the active ingredient, which includes the efficacy of the insecticide. Data on pesticide efficacy have not been evaluated by JMPS.
FAO specifications for agricultural pesticides are developed only if the manufacturer is registered in one or more countries, and the efficacy of these pesticides is often inferred from this evidence.
However, the efficacy of the active ingredients and formulations of public health pesticides will be evaluated in laboratory and field trials by the WHO Pesticide Evaluation Programme, usually when WHO/FAO develop technical material specifications. Following a satisfactory evaluation of safety and effectiveness, WHO formulation specifications are published.
Specifications may need to be developed in special circumstances, such as during the evaluation of the public health efficacy of a new product. WHO may develop interim specifications for preparation and may develop interim guidance specifications for the same purpose.
FAO/WHO specifications are intended for quality assurance and risk management. The assessment of pesticide-related hazards and risks for specification purposes is primarily based on assessments by national registration authorities and carried out by WHO units designated by WHOPES or other international organizations.
In the absence of institutional evaluation by a national registry, JMPR/JECFA or WHO/PCS, WHO/FAO arranges for a detailed evaluation of the original study before JMPS proceeds with specification development.
An important aspect of hazard and risk assessment is as below:
Determine the hazard and purity/impurity profile data submitted
The link between the submitted purity/impurity profile data and the purity/impurity limits applied under normal circumstances, manufacturing and production
FAO and WHO recognize that the generation of duplicate data on all potential/actual hazards by each pesticide manufacturer may be unnecessary and ethically undesirable.
The lack of a direct link in (i) above does not prevent the development or expansion of the specification, but the proposer must disclose the link, or lack thereof, to ensure that JMPS recommendations are based on an appropriately informed assessment of the hazards and risks.
The above information explains the pesticide and specifications. Especially for the specification, it should be evaluated by JMPR.
