This statement has been prepared to ensure and verify the transparency of the process of data evaluation by the JMPS (a process essential for the development of internationally acceptable specifications for pesticides), whilst complying with the legitimate need of Industry to protect trade secrets (e.g. the results of their research, confidential business information).
a) The proposer of a specification is asked to provide all pertinent data specified in sections 3.1 and 3.2 of this Manual, together with any other information justifiably required by FAO and/or WHO for the purposes of the JMPS. Confidential information pertaining to the manufacturing process and other trade secrets must be identified clearly by the proposer, so that this information will not be published in the evaluation summary or inadvertently divulged to third parties.
b) Where a manufacturer makes available confidential proprietary data or information, for the purposes of evaluation by the JMPS, FAO and WHO undertake to respect and safeguard the data from unauthorized release or disclosure and to provide the necessary facilities, at FAO Headquarters in Rome or WHO Headquarters in Geneva, to ensure the proper handling and security of the above mentioned data.
c) The Data Package received by FAO or WHO for evaluation will be sent to the expert, participating in the JMPS, to whom the compound has been assigned for evaluation for consideration by the forthcoming closed meeting (see glossary).
d) When FAO or WHO sends confidential proprietary data or information to a nominated expert participating in the JMPS, it will instruct the expert not to make copies of all or parts of the data, nor to share or use the data for anything other purpose than evaluation of the proposed specification and the corresponding presentation of the draft evaluation to the closed meeting. The expert will be asked to acknowledge in writing that he/she accepts these conditions by signing undertakings of confidentiality and restrictions on use.
e) At the closed meeting, experts participating in the JMPS will be required to sign an undertaking to respect the confidentiality of the proprietary data and the restrictions on use, and any discussions pertaining to them. The deliberations of the JMPS will be recorded in the confidential report of the closed meeting, to be held by FAO and WHO.
f) Experts participating in the JMPS will be required to sign a declaration of their actual or potential interests in the information, proposals or pesticides under consideration. Experts will not take part in discussions in which their declared interest gives rise to a conflict of interest, except to provide the JMPS with information, if required.
g) Following the closed meeting and completion of the evaluation and specifications, all data (including the proprietary data) will be returned to FAO or WHO by the assigned expert and kept secure at FAO or WHO Headquarters. Subsequently, the confidential data and information will be accessed only for the purposes of determination of equivalence or review of the specifications, under similar procedures. Confidential data and information do not become the property of FAO or WHO. When a specification is withdrawn, FAO or WHO will, if possible, contact the proposer who originally submitted the data, to determine whether the data package should be destroyed or returned to the proposer.
h) In the determination of equivalence, if the existing limit for a relevant impurity is exceeded by the additional TC/TK, FAO and/or WHO can be expected to request information from the additional proposer about the increased levels of relevant impurities. Where there is a new impurity, or an exceedance of the 50% or 3 g/kg limit for non-relevant impurities, requests for further information from the additional proposer will refer only to the impurity data provided by the second proposer. No reference will be made to the data owned by any other proposer other than that, by inference, it may be concluded that the 50% or 3 g/kg limit has been exceeded. In such cases, every care will be taken to avoid inadvertent release of confidential information.
