Hazard summary provided by the proposer

Provides a summary of information on acute and sub-acute to chronic toxicity (including carcinogenicity and teratogenicity); genotoxicity, and ecotoxicology, derived from technical grade active ingredient manufactured by the proposer. Provides information on the toxicity of relevant impurities, if available. Where data from this section have been evaluated by WHO or an institution nominated by WHOPES, for example to assist in the determination of equivalence, the evaluation is summarized in the appraisal, otherwise the information is neither evaluated nor summarized in the appraisal.

3.4.5 References

Published and unpublished documents, containing data or other information presented or mentioned in the report, are referenced. A reference section at the end of the evaluation of the confidential data should include the relevant studies and documents. A second reference section should be included at the end of the evaluation of non-confidential data for the relevant studies and documents there. Unpublished documents are referenced by study number (or document number), authors, year and title. and document

3. Data requirements and procedures, continued

number allocated by the sponsor. E-mails are referenced by author, date, sender‘s organization and FAO/WHO recipient.

FAO and WHO, before publication and during the final editorial process, will remove source details from the toxicological studies (e.g. author names) to protect the authors and laboratories from extremists.

The example shows the format for references.

References (sorted by study number Study

numbe r

Author(s) year Study title. Study identification number. Report identification number. GLP [if GLP]. Company conducting the study.

Title and journal reference for published documents.

Cambon J-P and Bastide J.

1996 Hydrolysis kinetics of thifensulfuron-methyl in aqueous buffer solutions. J. Agric. Food Chem. 44:333-337.

FAO/WHO 2006 Manual on development and use of FAO and WHO specifications for pesticides. February 2006 Revision of First Edition. FAO Plant Production and Protection Paper. Revised.

2000 CIPAC Handbook Volume J. Analysis of Technical and Formulated Pesticides.

XX-nnn Author AB and Writer CD

2007 Determination of melting point of pure and technical grade xoo6.

Study XX-nnn. Report XX-nnn.03. GLP. XYZ Contract Laboratories, XXland. Unpublished.

3.5 Decision making and action procedures for dealing with submissions from initial and subsequent proposers

Scenario 3.5.1

No FAO/WHO Specification exists for the pesticide

(a) A proposer or group of proposers submits a draft specification, supported by information in accordance with the requirements of Section 3.1.

(b) The JMPS assesses the impurity, toxicological and ecotoxicological profiles, to decide which impurities are relevant and must be specified.

(c) FAO/WHO agree the text of the evaluation and specification and the proposer checks it for factual accuracy.

(d) FAO/WHO publish the evaluation and specification, including the name(s) of the proposer(s) of the specifications for technical grade active ingredient(s) or formulation(s) recommended for adoption in the evaluation.

Scenario 3.5.2

Incorporation of a subsequent manufacturer's technical grade active ingredient or formulation(s) into an existing evaluation and the list of evaluations

(a) The subsequent proposer(s) provide(s) information in accordance with the requirements of section 3.2 (manufacturing process, impurity profile, short

3. Data requirements and procedures, continued

term toxicity and, where equivalence cannot be determined with this information, any additional toxicity data requested by the JMPS).

(b) The JMPS compares the new impurity, toxicological and ecotoxicological profiles with the original one(s), and recommends that FAO/WHO take actions as indicated below.

Case (i) Insufficient data are provided or the quality of the material is unacceptable.

Action: Rejection of the new submission.

Case (ii) Submission and quality of the material are acceptable and no change of the specification is needed.

Action: Add the name(s) of the subsequent proposer(s) to the evaluation and the list of evaluations to be published by FAO/WHO.

Case (iii) The quality of the material is acceptable but the specification must be changed to accommodate the additional material.

Action: Involve the proposer(s) already listed to develop a mutually agreed draft of a revised specification. If the listed proposer(s) do not wish to comment on, or cannot agree to, changes in the specification, the JMPS will recommend options for appropriate action by FAO/WHO.

3.6 Prioritization criteria for development and review of specifications FAO and WHO will prioritize the 3-year programme according to the following criteria, which are not presented in strict order of priority.

 Development of specifications for new active ingredients and/or formulations required by FAO or WHO for use in international programmes, e.g. for locust control and for control of major vector-borne diseases.

 Review of existing specifications for active ingredients or impurities with newly discovered serious health or environmental hazards and/or a rejection of re-registration at national/regional review for this reason.

 Review or development of specifications for active ingredients under evaluation or re-evaluation by JMPR.

 Development of specifications for new active ingredients or formulation types, as chosen by the proposer.

 Extension of existing specifications to encompass products manufactured by additional producers.

 Review of existing specifications where changes to the manufacturing process have occurred.

 Review of existing specifications where the active ingredients are, or are expected to become, subject to international agreements on Prior Informed Consent (PIC) or Persistent Organic Pollutants (POP).

3. Data requirements and procedures, continued

 Review of existing specifications where active ingredients are subject to withdrawal of national or regional registration, due to lack of supporting data.

 Review of existing specifications where active ingredients being reviewed by EU, USA, Japan and other regulatory authorities, under re-registration programmes.

 Review of existing specifications which are tentative, provisional or interim.

 Review of existing specifications older than 10 years where the pesticides are still marketed.

 Review of existing specifications where the pesticides are no longer marketed.

The three-year programme will be reviewed annually.