Prior to 1999, three categories of FAO specifications (tentative, provisional and full) were developed[13], differing in the CIPAC/AOAC status of the analytical methods for the active ingredient. Following a transitionary period, 1999-2000, only full specifications were adopted, using new procedures[14] similar to those presented in this Manual. From 2002, full specifications will be adopted according to the procedures given in this Manual.
Prior to the introduction of this Manual, two categories of WHO specifications (interim and full) were developed. The difference in status reflects the extent of peer review and the validation of the methods of analysis through collaborative study. From 2002, only full specifications will be developed, using the new procedures presented in this Manual. However, an interim period will be established by WHO, during which existing WHO interim specifications and specifications for pesticides currently under laboratory and field evaluation by WHOPES may be progressed under the old or new procedure.
The specifications developed by both organizations under the old procedures remain in force until they are reviewed using the current procedures, at which time either they will be withdrawn or they will be upgraded to full specification status. Priorities for review are given in section 3.5 of this Manual.
Specifications prepared according to the earlier procedures were applied to all products which were nominally similar. That is, for a defined active ingredient, the specification applied to all products containing that active ingredient, providing they were of the appropriate formulation type. However, under the "new" procedures the FAO and WHO specifications do not apply to nominally similar products of other manufacturers, nor to those where the active ingredient is produced by other routes by the same manufacturer. The scope of these new specifications may be extended to similar products when the JMPS is satisfied that the additional products are equivalent to those which formed the basis of the reference specification (see glossary, Appendix C).
Initially, all proposals must be sent to FAO or WHO, or both if appropriate[15]. Proposals relating to the same active ingredient and/or the formulations but submitted by different manufacturers can be provided simultaneously or at different times, and submissions may be made jointly or independently. To facilitate communications, and at the discretion of FAO and/or WHO, subsequent dialogue and information exchange may occur between the proposer and the designated evaluator. In this case, all communications must be copied, or noted if verbal, to FAO and/or WHO.
FAO and WHO will organize, annually, open and closed meetings of the JMPS. Open meetings can be attended by anyone and are intended for discussion of specifications principles, new guidelines, amendments to the Manual, and so on. Closed meetings are restricted to JMPS members, and others invited FAO/WHO, because they involve consideration of commercially confidential information. Details are given in the glossary. Prior to these meetings, draft or revised specifications, together with the supporting data, will be evaluated by experts participating in the JMPS, as designated by FAO and/or WHO.
The overall purposes of the annual meetings are:
- to evaluate and confirm (or reject) new and revised specifications and to resolve issues or evaluations in dispute;
- to update and prepare the agenda of the JMPS for the following 3 years, taking into account any developments or emergent information which may necessitate changes in priority; and
- to advise FAO and WHO on specifications, relevant policy and procedures.
In open meetings (see glossary) the JMPS will consider issues of general importance to specifications and, in doing so, will seek the views of all interested parties.
In closed meetings, (see glossary) the JMPS will consider:
(i) evaluations and proposed specifications, involving commercially confidential data;
(ii) changes in technical requirements for, and policy on, specifications;
(iii) priorities for review of specifications in the forthcoming three years (see section 3.5);
and make appropriate recommendations to FAO and/or WHO.
If required, additional experts from academia, government and/or industry may be invited by FAO/WHO to attend certain sessions of the closed meetings, to provide information or opinion on problematic or contentious issues. All additional experts will be required to respect the confidentiality of the information and discussions, and to sign a declaration of conflict of interest, but their periods of attendance will be restricted to ensure that confidentiality of commercial information is strictly maintained. Industry experts will not, and the other additional experts may not, be permitted to participate in the development of final recommendations by the appointed experts.
FAO and WHO will maintain the confidentiality of all confidential information provided in support of proposed specifications[16]. By means of a letter of access provided by the proposer, FAO and/or WHO will seek, as a minimum, to establish that the data provided on purity and impurities are similar to those provided to one or more registration authorities in countries in which the proposer indicates that the pesticide is registered. Additional facts about the active ingredient or formulation will be sought only from the proposer. A specification will not be published without agreement between the proposers, the JMPS and FAO/WHO on the content but, irrespective of agreement on the specification, the JMPS evaluation will be published on the internet by FAO, WHO or both.
The procedure and deadlines are scheduled with reference to the annual FAO/WHO JMPS.
(i) In January, FAO and WHO will publish trawls[19] for pesticides to be included in the next 3-year programme of the JMPS and announce the dates of the following JMPS meeting. Intending proposers may request inclusion of new or revised specifications, by writing to FAO and/or WHO, at any time. Prior to each meeting, FAO and WHO will provide the JMPS with a summary of the requests received. Submission of a request will not guarantee its inclusion in the 3-year programme but the JMPS will consider as many requests as practicable.
(ii) Following publication of the 3-year programme, proposers will be required to provide draft specifications and the supporting data outlined in Sections 3.1 or 3.2. Proposers who are unable to provide the data required to support specifications, within the timetable given in paragraphs (iii) and (vi) below, must notify FAO and/or WHO as soon as possible, so that the programme may be adjusted accordingly. Where a pesticide is withdrawn from the 3-year programme, an alternative pesticide may be brought forward by FAO and WHO.
(iii) Proposers should submit draft specifications and supporting information to FAO or WHO, as appropriate, by 30 September. One printed copy of the supporting information and draft specification should be submitted, together with an electronic version, using templates available at (http://www.fao.org/ag/agp/agpp/pesticid or http://www.who.int/ctd/whopes). The guideline specifications provided in this manual must be used. If appropriate guidelines do not exist, proposers should refer to Section 1.4.4. The proposer must confirm whether or not the company’s data differ from those submitted to the FAO/WHO JMPR, the WHO/PCS and/or the registration authorities in at least one country in which the active ingredient or product is registered; and that all relevant information is included in the proposal.
(iv) On receipt of the draft specification(s) and supporting information for a pesticide, FAO or WHO will allocate it to an expert participating in the JMPS, for preliminary evaluation.
(v) If the toxicological and/or ecotoxicological data provided are identical to those submitted to the FAO/WHO JMPR or WHO/PCS, their evaluations of the hazards and risks will normally be incorporated into the JMPS evaluation. If the impurity, toxicological and/or ecotoxicological data are identical to those submitted to national authorities for the purposes of registration, registration of the active ingredient and formulations will normally be interpreted by the JMPS as acceptability of the hazards and risks. Registration authorities may be contacted for confirmation of the similarity of the impurity, toxicological or ecotoxicological data, utilizing the proposer’s letter authorizing access to the proprietary information. Where the data submitted to JMPS differ from those evaluated by the other organizations, the proposer will be asked for an explanation. Where no national, JMPR or WHO/PCS evaluation is available, a full assessment of the toxicological and ecotoxicological data by WHO/PCS will be essential before proceeding with the JMPS evaluation. The opinion of WHO/PCS on the toxicological and ecotoxicological data will be considered by the JMPS in all cases.
An important aspect of the assessment of hazards and risks is to determine the links between (i) the hazard and purity/impurity profile data submitted, and (ii) the purity/impurity profile data submitted and the limits for purity/impurities applied in normal manufacturing production. FAO and WHO recognise that generation of replicate data on all potential/actual hazards by each manufacturer of a pesticide may be unnecessary and ethically undesirable. The lack of direct links in (i), above, does not preclude development or extension of a specification but proposers are required to disclose the links, or lack of them, to ensure that JMPS recommendations are based upon a properly informed assessment of hazards and risks.
(v) The proposer should be notified of additional information required, if any, by 31 December.
(vi) The proposer should send additional information, as requested, to the evaluator and FAO/WHO by 28 February, if the proposal and corresponding evaluation are to be considered at the next meeting of the JMPS. All communications between the evaluator and proposer, related to the proposal under consideration, will be copied, or reported, to FAO/WHO.
(vii) The evaluator should consider the information provided and send a completed evaluation to FAO/WHO by 30 April, for circulation to the proposer and the experts participating in the JMPS.
(viii) Proposers who disagree with a draft evaluation, or who wish to present additional supporting data, should provide FAO/WHO with appropriate information at least 3 weeks before the meeting at which the evaluation is to be considered. FAO/WHO will send this information immediately to the evaluator.
(ix) The procedure for considering evaluations at meetings of the JMPS will be:-
- a presentation by the evaluator and consideration by the JMPS;
- followed, where the draft evaluation is disputed or input by the proposer is requested, by presentation of a case by the proposer and consideration by the JMPS;
- followed by withdrawal of the proposer and consideration of the final JMPS recommendation.
Post-meeting amendments involving anticipated subsequent responses from the proposer will be accepted for incorporation into the evaluation report. Depending upon the number and complexity of minor changes, the JMPS may recommend post-meeting circulation of the final draft evaluation and/or specifications, to ensure maintenance of agreement between the experts. Major changes, or unexpected and important emergent information from the proposer, will require that the submission is reconsidered by a future meeting.
Where the JMPS considers draft or revised specifications prepared by multiple proposers for the same pesticide, the proposers may address the JMPS individually or together, according to the proposers’ preference.
(x) If the JMPS is unable to reach a consensus, the proposer will be asked to provide data to resolve the outstanding issue(s), within a specified time. Following a recommendation to reject a proposed specification, a specification redrafted by the proposer may be considered at the next meeting, depending upon the priorities (see Section 3.5) and work load of the JMPS.
(xi) The basis for recommendations to accept or reject specifications will be recorded in the evaluation.
(xii) The proposer(s) will be identified in the evaluation (see Section 3.3), which will be cross-referenced with the specification(s).
(xiv) The specifications do not apply to the active ingredients or formulations of other manufacturers, nor to those produced by different processes, unless these have been evaluated as equivalent (see Section 3.2.E). If the proposer subsequently changes the manufacturing process significantly, re-evaluation by the JMPS will be required to ensure compliance with the specification. Changes in manufacturing process which would be considered significant can be identified in accordance with the test for equivalence described in section 3.2 of this Manual. The primary specification may be modified to accommodate the additional products, or those produced by the different process, depending upon the outcome of the JMPS evaluation. The reference profile of impurities will normally remain that associated with the specification as initially adopted.
Accepted, new or modified specifications and the corresponding evaluations will be published only on the internet. It is intended that publication should be within the calendar year in which the specifications are recommended for adoption. Hard copies may be provided on request from the addresses given in section 1.6 of this Manual. Only the latest versions of specifications will be accessible on the internet but all evaluations which refer to them will be available. The evaluations ensure that specifications are clearly based on a thorough consideration of all important issues, but they do not contain confidential information. The content of evaluation reports, and the nature and style of publications, will be determined by FAO and WHO. Specifications developed under the previous FAO and WHO systems will remain valid, until they are reviewed by the JMPS.
Methods of analysis are published in CIPAC Handbooks[20], or the AOAC Handbook[21] and Journal, and physical test methods are published in the CIPAC Handbooks. Methods in support of WHO specifications developed under the previous procedure are attached to the specifications.
Specifications will be reviewed at intervals, according to the priorities outlined in section 3.5 of this Manual. FAO and WHO will prepare a programme for review of all published specifications, which will be considered by the JMPS. As one of their responsibilities of product stewardship, and as a condition for maintaining an FAO or WHO specification, proposers must inform FAO/WHO of changes in the manufacturing process which have implications for the existing specification, and of changes in company name or address.
Specifications are published on the basis that information on the manufacturing process (confidential), impurity profiles, the hazard data available to FAO/WHO, and the manufacturer’s name and address remain valid. Proposers have a responsibility to inform FAO/WHO of changes in this information. Where the validity of this information is in doubt, the specification(s) may be scheduled for review by the JMPS. The manufacturer of a product evaluated by WHOPES, and based upon which evaluation the WHO recommendations for use and specifications have been developed, should notify WHO of any changes to the manufacturing process, formulation characteristics and/or formulants that could require re-evaluation of the product and/or review of the specification. Proposers may also request review of specifications.
Specifications under review must be supported by the data indicated in Sections 3.1 or 3.2 of this Manual (as appropriate).
The JMPS will then:
(i) confirm that the existing specification is suitable, or
(ii) recommend an amended specification, or
(iii) recommend that the specification be withdrawn.
Where national authorities find it necessary to adapt FAO or WHO specifications, FAO and WHO should be informed by the proposer, or the authority, of the changes made and the reasons for them. Such modified specifications cannot be considered to be FAO/WHO specifications but information supporting the changes will assist revisions of the specifications by the JMPS.
Comments and further information relating to specifications are welcomed by FAO and WHO. Proposals for modification of specifications should be supported by evidence to show that the change is pertinent to maintaining or improving the quality/performance, or to reducing the risks, of the technical grade active ingredient or formulation.
The following information should be submitted.
(i) The name, address and contact point of the proposer(s) of the specification.
(ii) Either the draft new specification or a statement of the specification to be extended.
(iii) Either the information described in section 3.1, to support a new specification, or the information described in section 3.2, to support the extension of an existing specification.
(iv) If the proposal is for joint FAO/WHO specifications, the proposer must state whether or not the materials used for both areas of application are similar and, unless different formulation specifications are proposed, that the specifications for the formulations are applicable to both agricultural and public health uses.
(v) Any other relevant information likely to help the JMPS to make sound recommendations.
All clauses in the draft specification should be presented in a standard form (see sections 5 to 9 of this Manual).
Analytical methods, supporting FAO and WHO specifications, for the determination of active ingredients in technical and formulated pesticides must be collaboratively tested and approved by CIPAC AOAC[22].
Analytical methods for determination of relevant impurities in the technical material must be peer (independent laboratory) validated (e.g. by the AOAC peer verified methods procedure) and preferably approved by AOAC, CIPAC. If the data have not yet been reviewed by such an organization, they may be submitted to the evaluator for consideration. In case of doubt, the JMPS may postpone a conclusion on the acceptability of the analytical method until the data have been reviewed by CIPAC or AOAC.
Where collaborative study, or peer validation, of the method of analysis is still in progress at the date of submitting the proposal, the estimated date of completion must be provided. Specifications will not normally be published prior to the completion of validation of the methods and, if the validation is unlikely to be completed before the next closed meeting of the JMPS, consideration of the proposal may be postponed.
Physical test methods may be validated by CIPAC or, in certain cases, by OECD, ASTM or the European Community. References to physical test methods in this Manual are prefixed "MT" for CIPAC methods, "EC" for European Community methods, or with the complete acronym for OECD or ASTM methods. These methods may be regarded as definitive as, in many cases, the physical property is defined by the method of measurement. Where more than one method is available, a referee method must be designated. Where a method is specified that has not been adopted by CIPAC, the specification should also define the property as measured by the most appropriate CIPAC method, if there is one. Unless it is considered to have been superseded, the CIPAC method will normally be considered the referee method.
Although the level of acceptance of methods within the CIPAC or AOAC systems is not completely critical, preference will be given to "full" or "final action" methods and the methods should normally have achieved a minimum of "provisional" or "first action" status. In addition to the emergence of new information on the active ingredient or the specifications, review of an existing specification may be triggered by revocation of the CIPAC/AOAC status of a method.
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[13] Manual on the
Development and Use of FAO Specifications for Plant Protection Products, 4th
Edition, FAO Plant Production and Protection Paper 128, FAO, Rome,
1995. [14] Manual on the Development and Use of FAO Specifications for Plant Protection Products, 5th Edition, FAO Plant Production and Protection Paper 149, FAO, Rome, 1999. [15] Correspondence, clearly marked "Confidential" if confidential information is included, should be addressed, as required, to: The Senior Officer (Pesticide Management Group), Plant Production and Protection Division, FAO, Viale delle Terme di Caracalla, 00100 Rome, Italy. Fax ++3906-5705-6347. WHO Pesticide Evaluation Scheme (WHOPES), Communicable
Disease Control, Prevention and Eradication, World Health Organization, 1211
Geneva 27, Switzerland. Fax: ++41 22 791 4869. The Senior Officer (Pesticide Management Group), Plant Production and Protection Division, FAO, Viale delle Terme di Caracalla, 00100 Rome, Italy. Fax ++3906-5705-6347. WHO Pesticide Evaluation Scheme (WHOPES), Communicable Disease Control,
Prevention and Eradication, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4869. |
