Minutes of the 240th Meeting of the Registration Committee held on 4.11.2003 at 2.30 PM. in Committee Room 142, Krishi Bhavan, New Delhi The 240th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. C.D. Mayee, Agriculture Commissioner on 4.11.2003 at 2.30 PM. in Committee Room No. 142, Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, PPA to the Govt. of India, Shri P.N. Maji, Joint Industrial Adviser, Department of Chemicals & Petrochemicals and Shri Y.Tsering Secretary, CIB & RC, members of the Committee attended the meeting. The following Officers from the Sectt. of CIB & RC were also present in the meeting: 1. 2. 3. 4. 6. 7. 8. 9. Dr. R.B.L. Bhaskar, JD(Bio) Dr. Brajendra Singh, Ento (I) Shri Vipin Bhatnagar, JD(Chem.) Er. S.K. Ghosh, DD (Engg.) Dr. B.S. Phogat, DD (Weed Science) Smt. Kanta Arora, A.O. (CIR) Shri Balbir Singh, SO Shri Neeraj Kulshrestha, Assistant (Legal) Agenda Item No 1.0 Confirmation of the minutes of the Registration Committee. 239th meeting of the While confirming the minutes of the 239th meeting, the Secretary Registration Committee apprised the contents of the letters No. P.15023/16/2003-PH (Food) dated16.10.2003 (annexed), received in the Secretariat of CIB&RC on 27.10.2003 regarding fixation of MRLs for Hexaconazole 2% EC from Dr. S.R. Gupta, ADG (PFA), Ministry of Health & Family Welfare, a co-opted member on the Committee. The Committee was apprised that Hexaconazole technical and Hexaconazole 5% EC were already registered about 10 year back. Hexaconazole 5% EC is approved for used on apple, rice, groundnut, mango, soybean and tea crops. Recently Hexaconazole 5% SC has also been approved for use on mango and rice crops. 2. The Committee observed that Dr. S.R. Gupta was co-opted on the Registration Committee on the advice of the Ministry of Health & Family Welfare since October 2000 to provide input relating to pesticide residues. Since his co-option, 37 meetings of the Committee have been held. Out of these, he has attended only 6 meetings and the last meeting which he attended was 221st. The Committee takes consensus decisions after taking the views of all the members present. Being co-opted member of the Committee, it is desirable that he attends the meetings regularly and provide his input during the deliberations of the Committee. Problems if 2 any, can be sorted out during the meetings itself instead sending comments after decisions have been taken by the Committee In view of the foregoing, the Committee decided not to take any cognizance of the letter received from Dr. Gupta and decided that a suitable communication may be sent to the Secretary, Ministry of Health & Family Welfare with the request to advise the co-opted member - a representative of the Ministry for attending the meetings of the RC on regular basis so to enable the Committee to take balance decisions Agenda Item No 2.0 Follow –up action on the decisions taken by the Registration Committee in its 239th meeting. The Committee perused the follow-up action taken by the Secretariat and advised that elaborate action taken may be brought up in the next meeting of the Registration Committee. Agenda Item No 2.1 Applications pending under various Sections of the Insecticides Act, 1968 The Committee noted the pendency under various SubSections of Section 9 of the Act with satisfaction Agenda Item Government Business No 3.0 Agenda Item Acceptance of data generated at Institute of Pesticide Formulation No 3.1 Technology (IPFT) on bio-efficacy parameters. The Registration Committee deliberated the agenda and decided that a Committee headed by the Chairman of the Registration Committee will visit IPFT, Gurgaon together with Dr. P.S. Chandurkar, PPA to the Government of India, Shri. P.N. Maji, Joint Industrial Adviser, Department of Chemicals & Petrochemicals and Shri Y, Tsering, Secretary, CIB&RC to assess the facilities available for generation of data on bio-efficacy in the Institute. . Agenda Item Restriction on use of Monocrotophos. No 3.2 The Committee deliberated the agenda and decided to defer the agenda in view of non-availability of input in the discipline of toxicology. 3 Agenda Item Clarification on issue of Certificates of Registration in respect of 2,4No 3.3 D Sodium Salt 80% WP The Committee deliberated the agenda and decided that Certificates of Registration under Section 9(4) may be issued as per the existing norms. Agenda Item Guidelines for permission to liquidate stocks of pesticides and their No 3.4 formulations and packaging material – Consequent to change of name of manufacturer / merger of manufacturing companies. Approved as proposed. Agenda Item Export cases No. 4.0 Agenda Item The applicants as per details at Annexure 4.1 have applied for grant No 4.1 of registration of the already registered technical / formulation having the same, lower and higher concentration / new concentration for export under Section 9(3) Approved. Agenda Item No. 5.0 9 (3B) Cases Agenda Item Consideration of application of /s Ajay Biotech Limited for grant of No. 5.1 extension of two years of Bacillus thuringiensis vs. Kurstaki 7.5% WP for data generation for existing registration under Section 9(3B). The Committee deliberated the agenda and decided to grant provisional registration which will be valid for one year with commercialization. The applicant shall be required to submit application on Form-I alongwith requisite fee. Agenda Item Consideration of request of M/s BMR, Pune for grant of No. 5.2 commercialization of their product neem oil based EC containing Azadirachtin 0.15% min. The Committee deliberated the agenda and reiterated its earlier advice given to M/s BMR & Co. while granting provision registration in its 186th meeting and further extension for one year in its 235th meeting held on 19.5.2003 that the applicant should generate data on various 4 identified parameters and submit the same for consideration of their application for commercialization. Agenda Item Action taken report of Agenda item no. 5.1 B(iii) of 239th meeting of No. 5.3 Registration Committee. The Committee deliberated the agenda and decided that the Chairman RC alongith PPA and Secretary CIB&RC shall visit Secretariat of CIB&RC to examine certain files relating to registration of biopesticides which have been filed on the data dossiers provided by TNAU / ICAR. Agenda Item No. 6.0 9 (3) Cases Agenda Item Consideration of application of M/s Gharda Chemical Ltd. for grant No. 6.1 of registration for indigenous manufacture of Fipronil technical under Section 9(3) Approved. Agenda Item Consideration of application of M/s FMC India Pvt. Ltd. for grant of No. 6.2 registration for import of Bifenthrin technical and indigenous manufacture of its 10% EC & 10% WP formulations under Section 9(3) The Committee noted the contents of the letter dated 3.11.2003, addressed to Chairman, R.C. from Dr. S.P. Gupta, ADG (PFA) (copy enclosed). As per decision of RC taken in its 222nd meeting, a set of information on prescribed proforma dully filled up by the applicant has been sent to ADG (PFA), Ministry of Health & Family Welfare, New Delhi on dated 30.07.2003 for working out MRL under the PFA Act. After due deliberation the Committee approved the case. The Committee also decided to send reply to Dr. Gupta. Agenda Item Consideration of application of M/s EID Parry for grant of No. 6.3 registration for import of Benfuracarb technical and of its formulations viz. 3% Gr. & 40% EC for indigenous manufacture under Section 9(3) The Committee noted the contents of the letter dated 3.11.2003, addressed to Chairman, R.C. from Dr. S.P. Gupta, ADG (PFA) (copy enclosed). As per decision of RC taken in its 222nd meeting, a set of information on prescribed proforma dully filled up by the applicant has been sent to ADG (PFA), Ministry of 5 Health & Family Welfare, New Delhi on dated 30.07.2003 for working out MRL under the PFA Act. After due deliberation the Committee approved the case. The Committee also decided to send reply to Dr. Gupta. Agenda Item Consideration of application of M/s BASF India Ltd. for grant of No. 6.4 registration for import of Dimethomorph technical and indigenous manufacture of its 50% WP formulation under Section 9(3) Approved. Agenda Item Consideration of application of M/s Tagros Chemical Ltd. for grant No. 6.5 of registration for indigenous manufacture of Deltamethrin technical under Section 9(3) Approved. Agenda Item Applications for registration under Section 9(4) No. 7.0 Agenda Item A statement showing the cases under Section 9(4) complete from No. 7.1 chemistry angle may be seen at Annexure 7.1 Approved. Agenda Item Consideration of application of M/s Tagros India Ltd., Chennai No. 7.2 under Section 9(4) for grant of registration of Imidacloprid technical for indigenous manufacture Approved. Agenda Item Consideration of application of M/s Mitsu Ltd., Vapi under Section No. 7.3 9(4) for grant of registration of Imidacloprid technical for indigenous manufacture Approved. Agenda Item Consideration of application of M/s EID Parry (India) Ltd., Chennai No. 7.4 under Section 9(4) for grant of registration of Alphamethrin technical for indigenous manufacture Approved 6 Agenda Item Consideration of application of M/s EID Parry India Ltd., Chennai No. 7.5 under Section 9(4) for grant of registration of Profenophos technical for indigenous manufacture Approved. Agenda Item Miscellaneous items No. 8.0 Agenda Item A statement showing the endorsement cases which are complete from No. 8.1 all disciplines may be seen at Annexure 8.1 Approved. Agenda Item HDPE woven sacks packaging system for transportation of No. 8.2 Carbendazim 12% + Mancozeb 63% WP from manufacturing plant to the repacking plants – proposed by M/s Indofil Chemicals Company, Mumbai .Approved. Agenda Item HDPE woven sacks packaging system for transportation of No. 8.3 Metalaxyl 8% + Mancozeb 64% WP (Matco 8-64 72%) WP from manufacturing plant to the repacking plants – proposed by M/s Indofil Chemicals Company, Mumbai Approved. Agenda Item Label expansion of Difenoconazole 25% EC for use on chilli for the No. 8.4 control of die-back and fruit rot diseases and on rice for the control of sheath blight disease by M/s Syngenta India Ltd., Mumbai. Approved. Agenda Item Expansion of label & leaflet claims of Propiconazole 25% EC on No. 8.5 banana for the control of Sigatoka leaf spot and on coffee for the control of leaf rust by M/s Syngenta India Ltd., Mumbai. Approved. Agenda Item Application of M/s Jaishree Agro Industries Ltd., Delhi for import of No. 8.6 sample quantity of Abamectin technical for the tests and trials purpose. While deliberating the agenda, the Committee observed that M/s Jayshree Agro Industries Ltd. not only imported technical from non- 7 permitted manufacturer but also distributed the material for data generation Therefore, RC decided that data generated with this material imported from non-permitted manufacturer will not be valid for registration purpose. The Committee also decided that the applicant may submit fresh request on prescribed form for approval of the Committee for import of sample quantity from specified manufacturer for data generation. Agenda Item Enhancement of Shelf Life. No. 8.7 The Committee deliberated the agenda in detail and endorsed the enhancement of shelf life of the products as proposed in the agenda. Any other item The Committee took note of the representation made by M/s Willowood Agro Chem Pvt. Ltd., Bikaner for registration of Acetamiprid technical file no. (i) 18-TI/9(3B)/02, Acetamiprid 3% EC, (ii) file No. 21-F/9(3)/02 and Abamectin 1.9% EC, (iii) file no. 5-FI/9(3B)/03. The Committee decided that these applications may be scrutinized on priority and status of the data submission may be put up in the next meeting for consideration 2. The Committee decided to hold next meeting of the Committee on rd 3 December, 2003.. The meeting ended with a Vote of Thanks to the Chair.