DGDs for severly hazardous pesticide formulations (SHPF)

Transcription

1 DGDs for severly hazardous pesticide formulations (SHPF) 1

2 Guidance for preparing a DGD on SHPF Chapter 1.3 Working paper on preparing internal proposals and decision guidance documents for SHPFs 2

3 Guidance for preparing a DGD on SHPF Intention: clarify the purpose of each section of the decision guidance document characterize the information to be included define acceptable sources of information for each section 3

4 Process of drafting DGD Co-chairs of the drafting group will receive an (electronic) example of a DGD for a severely hazardous pesticide formulation as a template and they will draft a first version. In the drafting process there are 3 commenting rounds 4

5 Sources of information for DGD Documents that have been available to the CRC during discussion of the proposal (UNEP-FAO-RC- CRC.X-Y + addenda) The wording of e.g. the description of the incident(s) should not be significantly changed For some sections infomation from international reviews may be used 5

6 DGD Structure - Sections General introduction Purpose, Disclaimer Standard core set of abbreviations Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Identification and uses Reason for inclusion in the PIC procedure Description of common and recognized pattern of use of the formulation in the reporting country Description of the incident(s), including adverse effects and way in which the formulation was used Any regulatory, administrative or other measure taken, or intended to be taken, by the proposing Party in response to such incidents WHO hazard classification of the formulation Section 7 Alternative pest-control practices 6

7 DGD Structure - Annexes Annex I Annex II Annex III Annex IV Rationale for the recommendation by the CRC to include the SHPF in the PIC procedure Information on reported incident from incident report Safety data sheet (s) on pesticide active ingredient(s) Further information on the pesticide active ingredient(s) Annex V References 7

8 General content of DGDs General Introduction Standard text including the date of adoption at the Conference of the Parties (not to be revised by CRC) Purpose of the decision guidance document (not to be revised by CRC) Disclaimer (not to be revised by CRC) Standard core set of abbreviations No need to delete abbreviations that are not used Add new abbreviations (if used more than once in the DGD) 8

9 1. Identification and uses This basic information should be obtained from part A of the submitted report form: Name or trade name of the hazardous pesticide formulation Name of the active ingredient(s) Relative amount of each active ingredient Type of formulation Name(s) of the producer(s), if available Molecular formula, chemical structure and CAS-No.(s) of active ingredient(s) Additional information may be obtained from standard reference documents (e.g. the Pesticide Manual) 9

10 2. Reasons for inclusion in the PIC procedure General statement that specifies the pesticide formulation(s) that led to problems under the conditions of use in a developing country or country with economy in transition. Standard text: These pesticide formulations were found to cause human health problems to the applicators under conditions of use in country XX, consistent with the provisions of Article 6 and Annex IV to the Convention. Reference to CRC rationale in Annex I 10

11 Example of DGD: paraquat formulation 11

12 3. Description of common and recognized pattern of use of the formulation in the reporting country Clear description of typical use in the reporting country 3.1 Permitted uses of the formulation Details on authorisation and conditions of use (crop, rate, time etc.) 3.2 Restrictions in handling or use Are there any restrictions (e.g. do not use under windy conditions, use only with xx type of spraying equipment ) Use of PPE on label / instructions for use? 3.3 Availability/applicability of protective clothing Proposal may include some reasoning that e.g. PPP is not available/affordable under the conditions of the proposing country 3.4 Actual uses Typical use conditions, especially where such use differs from officially registered uses 12

13 4. Description of the incident(s), including adverse effects and way in which the formulation was used Briefly describe the incident and the resulting adverse effects, and to relate how the formulation was used to the common and recognized patterns of use. 4.1 Description of the incident(s) Location, application method, route of exposure 4.2 Description of the adverse effects As described in incident report form (part B of proposal) 4.3 Relationship of the adverse effects observed to recognized acute toxicological effects of the active ingredient(s) Reference/quote from the relevant sections / international sources 4.4 Extent of incident (e.g. number of people affected for human health incidents) 13

14 Sections 5, 6, 7 5. Any regulatory, administrative or other measure taken, or intended to be taken, by the proposing Party in response to such incidents 6. WHO hazard classification of the formulation Hazard classification and toxicity class based on oral LD Alternative pest-control practices Brief information on alternatives that have been identified by proposing or other party + standard text as for all DGDs 14

15 Example of DGD: Fenthion formulation 15

16 Annex I, II and III Annex I: Rationale for CRC recommendation to include the SHPF in the PIC procedure Annex II: Information on reported incident from incident report Country name, DNA contact, part B of pesticide incident report form Annex III: Safety data sheet(s) on pesticide active ingredient(s) Complete WHO/FAO data sheet for each a.i. Product safety data sheet if available 16

17 Annex IV: Further information on the pesticide active ingredient - Similar to Annex I for DGDs for chemicals (there may be differences ) - Sources of information: information submitted by Parties (e.g. based on the their national assessments) and available to CRC results of international reviews such as from WHO / IPCS / JMPR / POPRC - General: introduction to annex should clearly state references used level of detail and focus should be on those area(s) of concern and related endpoints related to the incident(s) in order to avoid discrepancies, a range of values may be reported (e.g. LD mg/kg bw ) 17

18 Annex IV subsections 1. Physico-chemical properties 2.Toxicological properties - Including a summary with key properties / endpoints 3. Human exposure/risk evaluation 4. Environmental fate and effects 5. Environmental exposure/risk evaluation see example DGDs (Paraquat, Fenthion) 18

19 Example of DGD: paraquat formulation 19

20 Annex V List of References -Sources of information cited -Reference to review documents rather than to individual papers -If possible, add URLs 20

21 Lessons learned / Challenges DGD title clear definition of the formulation Title = how the chemical will be listed in Annex III No trade name in the title! XY formulations (XY) containing a.i. at or above xx g/l versus A.i. (XY formulations) at of above xx g/l Definition should cover formulations that potentially present a higher risk: at or above xx g/l is routinely added to prevent a changing of the formulation in direction of increased risk Example Paraquat SHPF: 2 formulation types covered "liquid formulations (EC and SC) containing " 21

22 Lessons learned / Challenges Not much experience with DGDs on SHPFs has been gained so far: Paraquat dichloride 200 g/l (adopted by CRC 8) Fenthion 640 g/l (adopted by CRC 10) Reported incidents that were the basis for the proposal of the SHPF tend to be very variable / chemical and use specific and need case-by-case reflection in the DGD 22

23 . Thank you! 23