The Joint Meeting on Pesticide Specifications (JMPS) is an expert ad hoc body administered jointly by FAO and WHO, composed of scientists collectively possessing expert knowledge of the development of specifications. Their opinions and recommendations to FAO/WHO are provided in their individual expert capacities, not as representatives of their countries or organizations. The primary function of the JMPS are to produce recommendations to FAO and/or WHO on the adoption, extension, modification or withdrawal of specifications and to develop guidance and procedures in establishing pesticide specifications and equivalence determination which has also its relevance to the registration and quality control of pesticide in national or regional authorities.
The Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) of the United Nations have published specifications for pesticides (referred to as FAO or WHO Specifications) and their related formulations, in addition to a manual on the development of these specifications.
- The FAO/WHO specification scheme is regarded as a benchmark representing a global standard of product quality.
- The specifications can be applied as a tool in risk assessment to ensure that products on the market meet minimum acceptable quality standards.
- The specifications offer protection for responsible manufacturers and vendors against inferior products.
- The specifications also provide an important link between biological efficacy and specification requirements.
Procedures for establishment for insecticides used in public health programs for insect control were first introduced by the WHO in 1953 and were codified in 1956 by means of publication of the first edition of the “Specifications for Pesticides”. Subsequently, the corresponding process for crop protection products was initiated by FAO in 1963. The separate processes in WHO and FAO continued in parallel until 2002, at which point the FAO and WHO collaborated to merge the two processes and the conjoined process are now being managed together under the auspices of the Joint Meeting on Pesticide Specifications (JMPS). In addition to the procedures detailed in the 2002 version of the Specifications Manual, WHO still separately oversees the efficacy requirements for public health products by means of the procedures outlined in the WHO Pesticide Evaluation Scheme (WHOPES).
Under the FAO/WHO Specifications procedure, manufacturers are encouraged to propose specifications for their products to the JMPS. In submitting the specification proposal, the proposer provides detailed requirements for the physical properties and physical performance of the technical material and formulated product.
Under a procedure initiated in 1999 and continuing under current practice, the proposer must in addition provide a “minimum” data package containing information on human health and environmental safety, as well as information on the manufacturing process and the resultant impurity profile of the technical material.
When the specifications proposal and accompanying data package are received by FAO/WHO, an evaluator for review of the package is appointed from the group of members of the JMPR panel of experts.
Firstly, the data package contains information concerning the identity of the active ingredient, specifically, the chemical name, structure and fundamental properties of the pure active substance, all of which will be publically disclosed and published along with the final specification. This section also includes the identification of any relevant impurities, defined as those that have toxicological, ecotoxicological, product stability or food taint significance. Next comes a series of items, which manufacturers consider highly confidential and which provides the basis for any equivalence decisions that may follow. These data include:
- Complete manufacturing process, including all raw materials, reagents and solvents
- Complete impurity profile for all impurities present at 1 g/kg or greater and maximum limits for impurities present at 1 g.kg or greater
- Five-batch analysis of typical manufacturing lots, supporting these impurity limits.
In addition to these confidential data, the package contains summaries of the acute, sub-acute and chronic toxicological properties of the technical material, including reproductive and developmental toxicity, genotoxicity and carcinogenicity. Likewise, summaries of the ecotoxicological profile of the technical material are provided, including toxicity to selected aquatic and terrestrial organisms. Finally, the proposer of the specification provides a letter of authorization, granting to FAO/WHO and to those acting on their behalf, access to the full registration studies that are on file with a competent governmental authority in a country where the product is registered.
Following review by the evaluator, the specification proposal is reviewed by the entire Panel of Experts or the FAO/WHO Joint Meeting on Pesticide Specifications. The manufacturer who is proposing the specification defends the proposal in a closed meeting. Following the review, the Panel meets in closed session to accept or reject the proposed specification. If and when the specification is accepted, FAO and WHO then publish the specification and the accompanying evaluation on the internet. The heart of the procedure and the portion on which products equivalence is based, is comprised of the “Data Requirements for Technical Materials”(TC).