CHEMICALS CURRENTLY UNDER REVIEW

SPINOX T and GRANOX TBC

DRAFTING GROUP MEMBERS:

Mr. Ikeda

Mr. Untung

Mr. Palikhe

Mr. Sibartie

Mr. Cable

Mr. Komives

Ms. Yang

Ms. N’doye

Mr. Debois

Mr. Ward

Mr. Arndt

Mr. Mayne

Secretariat

Coordinator: Ms. Barnes

Coordinator: Mr. Ammati

Secertariat: Bill Murray

RATIONALE:

Rationale For And Text Of The Draft Recommendation That Spinox T And Granox Tbc Should Become Subject To The Prior Informed Consent Procedure And To Establish An Intersessional Drafting Group To Prepare A Draft Decision Guidance Document (excerpt from UNEP/FAO/PIC/ICRC3/CRP.18)

a) The reliability of the evidence indicating that the use of the formulations, in accordance with common or recognized patterns of use within the proposing party result in the reported incidents.

The reported poisoning incidents were well documented, documents available were the completed incident report forms, a separate epidemiological study undertaken by representatives of the Senegalese government, the World Health Organization and others. They were further supported by information on the individual active ingredients collected from internationally recognized sources.

In reviewing this documentation there was concern that the onset of symptoms was not consistent with carbamate intoxication, given that it appeared that the majority of symptoms, including mortalities, occurred 45 to 120 days after the first exposure. However, it was recognized that this may be an artifact of the way in which the data were reported and probably reflected the time from when users first started applying the formulation, rather than the time between the last exposure and the onset of symptoms. In all cases, a precise link between the time of exposure and the onset of symptoms was difficult to establish. The reasons include: the data were collected retrospectively; the principal exposure occurred during sowing of treated seeds, an activity that takes place over a period of 5 to 10 days and may occur from May through August; and, written records of pesticide use are not typically maintained in the region. However, in some cases symptoms were reported from within a few hours to two days after exposure.

It was also noted that symptoms reported did not reflect the full range of those typically associated with cholinesterase inhibition. For carbamates, such symptoms as miosis and excess salivation are typically of short duration. Given that the data were collected some time after exposure, those symptoms would not be expected to be observed. In addition, it was noted that the forms used to collect the data may have influenced the symptoms reported, since it did not list the full range of symptoms representative of cholinesterase inhibition. The reported respiratory problems were considered to be indicative of lung oedema, normally a symptom of severe carbamate poisoning , and possibly a pre-condition to the reported limb oedemas. In addition supplementary information relevant to the nature and scope of the illness related to the use of the formulations was not available due to inadequate record keeping. In health centers and posts in the region.

In the design of the supporting epidemiological study there was a potentially confounding case controls selection, in that the controls may have also been exposed to pesticides. It was determined that while this was a potential weakness in the study it should not lead to discounting the overall results. The reasons for this include the following:

“ There was no difference between cases and controls regarding their participation in farm-work. None-the-less the distribution of sick cases in space and time shows that they were concentrated in the peanut farming areas soon after the beginning of the rainy season and during the season of agricultural labor, with a major peak in August when all farmers started or ended sowing….. In addition most controls were less exposed because they were ill during the period of sowing.” (Page 18, para 3).

The reported incidents were limited to the Kolda region of Senegal. It was noted that other regions where it had been expected that the formulations would be used had not received the pesticide, and in those regions no incidents of poisoning had been recorded. Kolda was the region in which it was also reported that as a result of a new agricultural policy there was an increase in the yield of peanuts associated with more intensive farming practices. This increased intensity of production was associated with increased pesticide use. It was reported that associated with the increased peanut production the quantities of pesticides available to farmers doubled and even tripled. (page 17 para 5.4.3).

It was confirmed that the 22 incident reports considered by the Committee involved exposure to the Spinox/Granox formulations only. In addition a representative from PAN Africa confirmed that the Spinox T and Granox TBC were the only pesticide formulations directly available to farmers in the region. This information was considered to reinforce the link between exposure to these formulations and the observed effects.

While it was recognized that there some elements of the data available to the Committee could be challenged, it was agreed that the overall weight of evidence clearly indicated that the use of the formulations in accordance with common and recognized practices within Senegal resulted in the reported incidents.

b) The relevance of such incidents to other States with similar climate conditions an patterns of use of the formulation;

It was agreed that the information about the reported incidents and the formulation was relevant to other Parties particularly those with similar climatic conditions and levels of awareness among agricultural workers and that are producing peanuts using similar cropping systems.

c) The existence of handling or applicator restrictions involving technology or techniques that may not be reasonably or widely applied in states lacking he necessary infrastructure.

Information on restrictions about this specific formulation is not available. However for carbofuran, most formulations are retricted to trained personal wearing suitable protective clothing (e.g. protective impermeable boots, clean overall, gloves and a respirator or other technology designed to minimize applicator exposure such as closed cabs or closed systems of mixing, loading and application). It was also noted that based on the request for information on these formulations no powdered formulations of carbofuran were approved in 25 countries or the European Community.

It was agreed that such techniques and technologies considered necessary to reduce exposure to acceptable levels in developed countries would not be expected to be available or feasible in developing countries lacking the necessary infrastructure and with a hot and humid climate.

d) The significance of reported effects in relation to the quantity of pesticide used;

The reported effects included mortality and were observed with increased frequency in the region where there was increased use of the formulations.

e) The intentional misuse is not in itself an adequate reason to list a formulation in Annex III

The incidents reported were not the result of intentional misuse but occurred as a result of using the formulations in accordance with common or recognized practices in Senegal.

SCHEDULE FOR SPIMOX T AND GRANOC TBC

Tasks to be carried out, responsible persons, and deadlines:

Task	Responsible persons	Deadline
Draft a single “internal proposal” on Spinox T and Granox TBC based on the information available to ICRC-3.	Cathleen Barnes and Mohamed Ammati	15 May 2002
Send draft “internal proposal” to group members for comments via e-mail.	Cathleen Barnes and Mohamed Ammati	15 May 2002
Replies	All DG members	15 June 2002
Update “internal proposal” based on the comments from group members.	Cathleen Barnes and Mohamed Ammati	15 July 2002
Send updated “internal proposal” to the ICRC and its observers for comments via e-mail	Cathleen Barnes and Mohamed Ammati	15 July 2002
Replies	All ICRC members and observers	1 September 2002
Draft a decision guidance document (DGD) based on the comments from the ICRC and its observers	Cathleen Barnes and Mohamed Ammati	1 October 2002
Send draft DGD to group members for comments via e-mail	Cathleen Barnes and Mohamed Ammati	1 October 2002
Replies	All DG members	22 October 2002.
Finalize draft DGD based on the comments of the group.	Cathleen Barnes and Mohamed Ammati	1 November 2002
Send the draft DGD to secretariat	Cathleen Barnes and Mohamed Ammati	1 November 2002
ICRC meeting		March 2003

RELEVANT DOCUMENTS FOR THE WORK OF THE DRAFTING GROUP

Code of Document	Name of the document	Comments
UNEP/FAO/PIC/ICRC.3/CRP.16:	Working paper on the content of a DGD for severely hazardous pesticide formulations causing human health problems	Copy attached in Appendix III
UNEP/FAO/PIC/ICRC.3/17	Inclusion of Chemicals in the Interim Prior Informed Consent Procedure: Review of Proposals for severely hazardous pesticide formulations – Granox TBC and Spinox T	Incident report forms (Parts A and B) for both Granox TBC and Spinox T and summaries in English
UNEP/FAO/PIC/ICRC.3/17.Add.1	Inclusion of Chemicals in the Interim Prior Informed Consent Procedure: Review of Proposals for severely hazardous pesticide formulations – Granox TBC and Spinox T	Additional information collected by the Secretariat: DNAs who responded to the request for additional information, calculation on toxicity values, translation of labels, extract of information provided by PAN Africa, JMPR reviews, Pesticide Data Sheets, International Chemical Safety Cards, EXTOXNET Profiles.
UNEP/FAO/PIC/ICRC.3/17.Add.2	Inclusion of Chemicals in the Interim Prior Informed Consent Procedure: Review of Proposals for severely hazardous pesticide formulations – Granox TBC and Spinox T	Additional information collected by the Secretariat: Comments from Crop Life International
UNEP/FAO/PIC/ICRC.3/17.Add.3	Inclusion of Chemicals in the Interim Prior Informed Consent Procedure: Review of Proposals for severely hazardous pesticide formulations – Granox TBC and Spinox T	Additional information collected by the Secretariat: DNAs who responded to the request for additional information, report of the research on the epidemic of an unknown etiologic illness in Kolda, comments from Crop Life International
UNEP/FAO/PIC/ICRC.3/CRP.6:	Review of proposals for severely hazardous pesticide formulation- Comments received from the representative designated by the United States of America	Comments received from the representative designated by the United States of America
UNEP/FAO/PIC/ICRC.3/CRP.15:	Report of the drafting group on Granox TBC and Spinox T	Includes membership and workplan
UNEP/FAO/PIC/ICRC.3/CRP.18:	Rationale for and text of the draft recommendation that Spinox T and Granox TBC become subject to the PIC procedure and to establish an intersessional drafting group to prepare a draft decision guidance document	Rationale for draft recommendation on GRANOX TBC and SPINOX T