Minutes of the 297th meeting of the Registration Committee held on 29. 01.2009 at 11.00 A.M. in Room No.142, Krishi Bhawan, New Delhi. The 297th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 29.01.2009 at 11.00 A.M. in Krishi Bhavan, New Delhi. Dr. P. S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. T.P. Rajendran, ADG(PP), ICAR, Shri Janak Raj, AD(CI) (representing for Drug Controller of India), Dr.P.N.Maji, (Special Invitee), and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting. Following officers from the Secretariat of CIB&RC were also present: (i) Dr. S.K. Khurana, Specialist Gr. I (ii) Dr. Hari Prashad, Jt.Dir(Chemistry) (iii) Dr. A.K. Sinha, Jt. Dir(PP) (iv) Dr.B.S. Phogat, JD(Bio) (v) Shri Vipin Bhatnagar, Deputy Director(Chem) (vi) Dr. R.M. Shukla, Deputy Director(Ento.) (vii) Dr. Subhash Kumar, Agro(H) (viii) Miss Kamlesh Miglani, AD(Chem) (ix) Shri R.C.Gulati, SO(CIR-I) (x) Shri S.K. Verma, SO(CIR-II) (xi) Sh. Niraj Kulshrestha, Assistant(Legal) At the outset the Chairman welcomed the participants and requested Secretary, CIB&RC to take up Agenda for discussion. The following decisions were taken: Agenda item No.1.0 Confirmation of minutes of the 296th meeting of the Registration Committee The Minutes of the 296th meeting of the Registration Committee (RC) were confirmed. Agenda item No.2.0 Follow up action on the decision taken by the Registration Committee in its 296th meeting. The Committee noted with satisfaction the status of follow-up actions taken. Agenda item No.2.1 Applications pending under various Sub-Sections of the Insecticides Act, 1968 The Committee noted the statement with reference to pending applications. 1 Presentation By representative of M/s Biotech International Ltd., for change of dose of Bacillus thringensis israelensis WP Agenda item No.2.2 The representative of M/s.Biotech International Ltd., New Delhi, made presentation regarding the amendments in the doses of Bacillus thringensis israelensis (Bti) WP from 5.0 kg to 2.0-5.0 kg per hectare. The Committee noted that earlier only one study with 2.5 kg per hectare was available and multi-centric study with 5.0 kg per hectare is available, therefore, the dose of 5.0 kg per hectare was approved. However, now, the multi-centric trial with 2.0 kg per hectare dose have been conducted and found effective against different species of mosquito, therefore, the Committee decided to approve the dose of 2.0-5.0 kg per hectare. Presentation by the representative of M/s Rohm and Haas (India) Pvt. Ltd. for 1-methylcyclopropene Agenda item No.2.3 The presentation for seeking exemption for submission of certain bio-efficacy and toxicity data was made by the representative of M/s. Rohm & Haas(I) Pvt. Ltd. for 1-methylcyclopropene(MCP). After the presentation, the Committee decided that the exemption sought by the applicant may be examined in the Sectt. of CIB&RC and comments of the Sectt., thereof, be brought to the next meeting of the Registration Committee. Agenda item No.3.0 Government Business Agenda item No.3.1 Guidelines for regn. of Bio-pesticides and guidelines for minimum infrastructures facilities to be created by the manufacturers of Bio-pesticides The Committee deliberated the agenda in detail and agreed to the decision taken in the meeting held on 17.12.2008, except the decision at S.No.2, i.e. to replace the data for absence of chemicals, botanicals contaminants with the affidavit. The Committee further decided that this point needs further deliberation. The Committee also decided that no application as per old guidelines be accepted w.e.f. 01.01.2010. Agenda item No 4.0 Export Cases 2 Agenda item No 4.1 List of applications u/s.9(3)Export Approved. Agenda item No 4.2 Consideration of application of M/s Parijat Industries (I) Pvt. Ltd. for regn. of Pyridaben tech. for export only. Approved. Agenda item No 4.3 Consideration of application of M/s Parijat Industries (I) P. Ltd. for regn. of Flutriafol Tech. for export only. Approved. Agenda item No 4.4 Consideration of application of M/s Swarup Chemicals (P) Ltd. for regn. for indigenous manufacture of Folpet Tech. for export only. Approved Agenda item No 4.5 Consideration of application of M/s United Phosphorus Ltd for grant of regn. for indigenous manufacture of Copper 12% + Mancozeb 30% WG Approved. Agenda item No 4.6 Consideration of application of M/s Bharat Rasayan Ltd for grant of regn. for indigenous manufacture of Bispyribac SodiumTech Approved. Agenda item No 5.0 9(3B) Cases . Agenda item No 5.1 Consideration of application of M/s Kundu Agro Chem(P) Ltd, for grant of regn. for indigenous manufacture of Pseudomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda item No 5.2 Consideration of application of M/s Advance Crop care (I) Pvt. Ltd., for grant of regn. for indigenous manufacture of Trichoderma viride 1.0% WP Approved for a period of two years with commercialization. Agenda item No 5.3 Consideration of application of M/s Super Pesticides & Agro (I) Pvt. Ltd. for grant of regn. for indigenous manufacture of Trichoderma harzianum 1% WP Approved for a period of two years with commercialization. 3 Agenda item No 5.4 Consideration of application of M/s Shree Shiva Bio Tech. for grant of regn. for indigenous manufacture of Bacillus thuringiensis var. kurstaki 0.5% WP Approved for a period of two years with commercialization.. Agenda item No 5.5 Consideration of application of M/s Shree Shiva BioTech,. for grant of regn. for indigenous manufacture of Paecilomyces lilacinus 1% WP Approved for a period of two years with commercialization. Agenda item No 5.6 Consideration of application of M/s Ruchi Biochemicals for grant of regn. for indigenous manufacture of Verticillium lecannii 1.15%WP Approved for a period of two years with commercialization. Agenda item No 5.7 Consideration of application of M/s Nirmal Organo Bio-Tech Pvt. Ltd. for grant of regn. for indigenous manufacture of Bio-Prahar (Photorhabdus luminescens akhurstii strain K-1) The Committee deliberated the agenda in detail and decided that applicant may be asked to make presentation in the next meeting of the Registration Committee regarding the efficacy, stability and coding of the product. Agenda item No 5.8 Consideration of application of M/s Biotech International Ltd. for grant of regn. for indigenous manufacture of Beauveria bassiana 1.5% AS Approved for a period of two years with commercialization. Agenda item No 5.9 Consideration of application of M/s Sujay Bio-Tech Pvt. Ltd. for grant of regn. for indigenous manufacture of Beauveria bassiana 1.15%WP Approved for a period of two years with commercialization. Agenda item No 5.10 Consideration of application of M/s Ganesh Biocontrol System for extn. of validity period of Regn. Certificate of NPV of Spodoptera litura 2.0% AS Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. 4 Consideration of application of M/s Prathibha Biotech for extn. of validity period of prov. certificate of registration of Pseudomonas fluorescens 0.5% WP for two year. Approved for a period of one year with commercialization. The Committee also decided that Agenda item No 5.11 the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Consideration of application of M/s Prathibha Biotech for extn. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for two year. Approved for a period of one year with commercialization. The Committee also decided that Agenda item No 5.12 the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Consideration of application of M/s Krishna Industrial Corporation Ltd. . for extn.. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for one year. Approved for a period of one year with commercialization. The Committee also decided that Agenda item No 5.13 the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Consideration of application of M/s Krishna Industrial Corporation Ltd. for extn. of validity period of prov. certificate of registration of Pseudomonas fluorescens 0.5% WP for one year Approved for a period of one year with commercialization. The Committee also decided that the Agenda item No 5.14 applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.15 Consideration of application of M/s Sri Biotech Laboratories India Pvt. Ltd., Hyd. for extn. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for one year. Approved for a period of one year with commercialization The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. 5 Agenda item No 5.16 Consideration of application of M/s Sun Biosystem Pvt. Ltd.,Chennai for extn. of validity period of prov. certificate of registration of Pseuodomonas fluorescens 0.5%WP for one year. Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.17 Consideration of application of M/s Vishwa Mithra Bio Agro (P) Ltd., Guntur for extn.. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for two year. Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.18 Consideration of application of M/s Shree Jee Biotech Agri.& Equipments, Wardha. for extn.. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for two year. Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Consideration of application of M/s Samiridhi Bioculture Pvt. Ltd., Indore for extn.. of validity period of prov. certificate of registration of Trichoderma viride 1% WP for one year. Approved for a period of one year with commercialization. The Committee also decided that Agenda item No 5.19 the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.20 Consideration of application of M/s Multiplex Biotech (P).Ltd., Banglore for extension of validity period of Registration Certificate of Beauveria bassiana 1.15% WP for control of Helicoverpa armigera on chickpea. 6 Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.21 Consideration of application of M/s Rajshree Sugars & Chemicals Ltd., Coimbatore for extn. of validity period of provincial certificate of registration of Trichoderma viride 1% WP for one year. Approved for a period of one year with commercialization The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 5.22 Consideration of application of M/s Vishwa Mithra Bio Agro(P) Ltd.,Guntur for extn.. of validity period of prov. certificate of registration of Metarhizium anisopliae 1.15% WP for one year. Approved for a period of one year with commercialization. The Committee also decided that the applicant should submit complete data as per the guidelines of the Registration Committee for 9(3) registration during this period. Agenda item No 6.0 9(3) Cases Agenda item No 6.1 Consideration of application of M/s Godrej Hicare Ltd. for grant of regn. for indigenous manufacture of Fipronil 0.05% Gel formulation Approved. Agenda item No 6.2 Consideration of application of M/s Bayer Crop Science Ltd for grant of regn. for import of Fipronil 80% WG formulation The Committee deliberated the agenda in detail and approved the application. Further, the Committee decided that a cautionary statement “Do not use the product near the areas of BeeKeeping” is to be included in the label and leaflets. Agenda item No 6.3 Consideration of application of M/s Bayer Crop Science Ltd for grant of regn. for import of Spiromesifen Tech. & indigenous manufacture of Spiromesifen 22.9% SC Approved. Agenda item No 6.4 Consideration of application of M/s FMC India Pvt. Ltd. for grant of regn. for import of Bifenthrin 23.4% MUP Approved. 7 Agenda item No 6.5 Consideration of application of M/s P.I. Industries Pvt. Ltd. for grant of regn. for import of Bispyribac Sodium 10% SC Approved. Agenda item No 6.6 Consideration of application of M/s Rallis India Ltd for grant of regn. for indigenous manufacture of Indoxacarb 14.5%+Acetamiprid 7.7% SC Approved. Agenda item No 6.7 Consideration of application of M/s Rallis India Ltd for grant of regn. for indigenous manufacture of Kresoxim-Methyl 44.3% w/w Approved. Agenda item No 7.0 9(4) Cases Agenda item No 7.1 List of applications for registration u/s 9(4) The Committee approved the applications, which are complete from Chemistry angle and for which MRL are fixed, partially fixed or not required. Further, applications at S.No.2921,2922, 2923 & 2893, which have been mentioned for rejection/clarification, are o.k. from Chemistry. Agenda item No 7.2 Consideration of application of M/s Krishi Rasayan Pvt. Ltd. for registration of indigenous manufacture of Gibberellic Acid Tech. u/s 9(4) Approved. Agenda item No 8.0 Endorsement Cases Agenda item No 8.1 Request from M/s. United Phosphorus for the endorsement of alternate packaging for Piroxofoppropanyl(Clodinafop-Propargyl)15% WP Approved. Agenda item No 8.2 Request from M/s. United Phosphorus Ltd. for the endorsement of alternate packaging for Sulfosulfuron 75% WG. Approved. Agenda item No 8.3 Request from M/s. United Phosphorus Ltd. for the endorsement of alternate packaging for Mancozeb 75% WP The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Indian Institute of Packaging, New Delhi. 8 Request from M/s. United Phosphorus Ltd. for the endorsement of alternate packaging for Carbendazim 12% + Mancozeb 63% WP. Approved. Agenda item No 8.4 Agenda item No 8.5 Request for M/s. S.C. Johnson Products Pvt. For the endorsement of alternate packing from PVC to PET bottles for packaging of Transfluthrin 0.88%LV. The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Indian Institute of Packaging, New Delhi. Request from M/s.Reckitt Benckiser(India) for the endorsement of additional packing of Imiprothrin 0.07% + Cypermethrin 0.2% Aerosol. The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Agenda item No 8.6 Indian Institute of Packaging, New Delhi. Request from M/s. Syngenta India Ltd for endorsement of alternate packaging of Difenoconazole 25% EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Agenda item No 8.7 Indian Institute of Packaging, New Delhi. Request from M/s. Syngenta (I) Ltd. for the endorsement of alternate packing of Lufenuron 5.4% EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Agenda item No 8.8 Indian Institute of Packaging, New Delhi. Agenda item No 8.9 Request from M/s. Syngenta India Ltd for the endorsement of alternate packing of Propiconazole 25% EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Indian Institute of Packaging, New Delhi. Request from M/s.Bayer Crop Science Ltd. for the endorsement of alternate packing of Fenamidon 10 + Mancozeb 50%-60% WG The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Agenda item No. 8.10 Indian Institute of Packaging, New Delhi. Request from M/s.Bayer Crop Science Ltd. for endorsement of additional packing of Fenoxaprop-p-ethyl 9.3% EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Agenda item No 8.11 Indian Institute of Packaging, New Delhi. Agenda Item No.8.12 Request from M/s. FMC Pvt. Ltd. for endorsement of alternate packing of Carbosulfan 25%EC 9 The Committee decided to seek the comments of Dr.Madhav Chakraborty, Coopted Member, Indian Institute of Packaging, New Delhi. Agenda Item No.8.13 Request from M/s. FMC Pvt. Ltd. for endorsement of alternate packing of Carfentrazone-ethyl 40%EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Co-opted Member, Indian Institute of Packaging, New Delhi. Agenda Item No.8.14 Request from M/s. FMC Pvt. Ltd. for endorsement of alternate packing of Bifenthrin 10%EC The Committee decided to seek the comments of Dr.Madhav Chakraborty, Coopted Member, Indian Institute of Packaging, New Delhi. Agenda Item No.8.15 Request from M/s.E.I. Dupont Pvt. Ltd. for inclusion of Surfactant packaging in the already approved manner for Chlorimuron ethyl 25% WP Approved. Agenda Item No.8.16 Request from M/s.Dhanuka Agri Tech Ltd. for label expansion of Quizalofop Ethyl 5% EC on cotton and groundnut The Committee deliberated the agenda in detail and accepted the request of the applicant to exempt the data on persistence on plant. Agenda Item No.8.17 Agenda Item No.8.18 Agenda Item No.8.19 Request from M/s. Bayer Crop Science Ltd. for extension of bioefficacy claim in Okra crop of Imidacloprid 70% WG Approved. Request from M/s. Chemtura Chemicals India Pvt. Ltd. for extension of bio-efficacy claim for control of housefly maggots in Poultry manures Approved. Request from M/s.Hyderabad Chemicals Ltd., Hyderabad for change of name of source of Carbofuran technical Approved. Agenda Item No.9.0 Miscellaneous Items Agenda Item No.9.1 Approval of Protocols Agenda Item No.9.2 Approved Request of M/s.Monsanto India Ltd. for approval of protocol to access the impact of Butachlor spray on aquatic organisms Agenda Item No.9.3 Approved Request of M/s. Shri Ram Solvent Extractions Pvt. Ltd. for enhancement of shelf -life of Pseudomonas fluorescens 0.5% WP Approved 10 Agenda Item No.9.4 Agenda Item No.9.5 Agenda Item No.9.6 Agenda Item No.9.7 Agenda Item No.9.8 Agenda Item No.9.9 Agenda Item No.9.10 Request of M/s. Shri Ram Solvent Extractions (P) Ltd. for enhancement of shelf life of Trichoderma viride 1% WP Approved Request of M/s. Vaibhavalaxmi Bio-Control Lab, Wardha for enhancement of shelf life of Trichoderma viride 1% WP Approved Re-validation of certificate of reg. for import of Methyl Bromide Tech. of M/s.Central Warehousing Corporation. Approved Re-validation of certificate of regn. for import by M/s. Sunshine Fine Chemical(I) Ltd., Pune Approved Revalidation of certificate of regn. for import by M/s.Pacific Agricrop Sciences(P) Ltd. Approved Revalidation of certificate of regn. for import by M/s. Imperial Cropcare (P) Ltd. Approved . Request for acceptance of Bio-efficacy data for regn. Of Clodinafop Propargyl 15% + Metsulfuron methyl 1% WP by M/s.United Phosphorous Ltd. The Committee approved the submission of data for registration as per old guidelines, provided the application for registration is received within a period of three months. Agenda Item No.9.11 Request from M/s. Syngenta India Ltd. for data generation & submission of requirement for regn. of herbicide Triasulfuron 20% WG on tea crop as per old guidelines. The Committee approved the submission of data for registration as per old guidelines, provided the application for registration is received within a period of three months. Agenda Item No.9.12 Consideration of applications for enhancement of shelf-life under section 9(4) Approved Agenda Item No.9.13 Ex-post facto approval for import permits Agenda Item No.9.14 Approved Consideration of application for import permit for Boric Acid and other substances for non-insecticidal use. The Committee deliberated the agenda in detail and the decision of the Committee in each case is given against respective applicant in Part I, II and III. 11 Agenda Item No.10.0 Any other item with the Permission of Chair The proforma which is in use for bringing the agenda related to boric acid approval should include few more columns which are as follows: (i) Submission of Pollution Control Board recommendation. (ii) Sion norms for the product in which boric acid is used indicating percentage use. The meeting ended with a vote of thanks to the Chair. ****** 12 Annexure Part – I STATUS OF PENDING APPLICATIONS FOR IMPORT PERMIT OF BORIC ACID S.No Name of the Applicant (M/s) 1 2 1. Galaxy Glass Inds, 8-A, National Highway, B/h, 132, K.V.A. Lalpar Power Station, Lalpar, Morbi – 363 642 (Gujarat) Lr.No. NIL dt 29th November,2008 Glass & 2. Welsuit Ceramic Pvt. Ltd., Nr. D.G.G. Gas Station, Padra-Jambusar Highway, Opp. Haldyn Glass, Gavasad- 391 430 Letter No. NIL dated 3rd December, 2008 3. M/s Sahej Cerchem Pvt. Limited, 47, Vijay Nagar Colony (Old), Agra – 282 004. Leter No. 200809/AGRA/719 dated 14.01.2009 Decision of the RC 3 Approved issuance of import permit for import of 50 MT of Boric acid for the remaining part of the year in view of the quantity consumed during first six months of the year as well as in view of the end-use certificate issued by DIC, Rajkot. Constituted a Committee, led by an officer of Registration Secretariat to visit the premises of Welsuit and report to Registration Committee within two weeks. The Committee also approved issuance of import permit for import of 100 MT of Boric acid in the meantime for meeting the contingency by the applicant for the year 2009. Approved issuance of import permit for import of 100 MT of Boric acid for the remaining part of the year in view of the quantity already consumed during the year as well as in view of the end-use certificate issued by DIC, Agra. 13 Part-II STATUS OF PENDING APPLICATIONS FOR IMPORT PERMIT OF DUAL USE INSECTICIDES (EXCEPT BORIC ACID) Sl. No. 1 1. 2. 3. Name of the Applicant (M/s) 2 Gharda Chemicals Ltd., 5/6, Jer Mansion, W.P. Varde Road, Bandra (W), Mumbai Salem Dist., Tamil Nadu Letter No. Nil dated 5th January, 2009 Divi’s Laboratories Limited, Divi Towers, 71-77/E/1/303, Dharam Karan Road, Ameerpet, Hyderabad – 500 016 Letter No. NIL dated 17.12.2008 M/s Kanoria Chemicals & Industries limited, P.O. Renukoot -231 217. (Distt Sonebhadra), U.P. Letter No. NIL dated 11.12.2008 Decision of the RC 3 Approved issuance of import permit for import of 3000 MT of Acrylonitrile in view of the quantity consumed during the preceding years as well as the recommendation of the Nodal Ministry. Approved issuance of import permit for import of 180 MT of Sodium Cyanide in view of the quantity consumed during the preceding years as well as holding the Poison License, subject to the verification of original Poisons License. Approved issuance of import permit for import of 308 MT of Barium Carbonate in view of the quantity consumed during the preceding years as well as the recommendation of the Nodal Ministry. 14 Part – III Representations for Issuance of Import Permit for Dual Use Insecticides S.No 1 1. 2. 3. Name of the Applicant (M/s) 2 Decision of the RC OCL India Ltd. Stephen House, 4, B.B.D. Bag (East), P.B. No. 838, Kolkata– 700001 Lr.No.CL/100/401 dt 15th December,2008 Divi’s Laboratories Limited, Divi Towers, 71-77/E/1/303, Dharam Karan Road, Ameerpet, Hyderabad – 500 016 Letter No. NIL dated 17.12.2008 Container Corporation of India, Inland Container Depot, Vil. Maliwada, Daulatabad, Aurangabad. (M.S.) Letter No. CONCOR/AWB/Auctio n/2009/263 dated December 23, 2008. The Committee did not agree to grant more quantity as no scientific justification has been put forth by the applicant for enhancement of the quantity already granted. 3 The Committee deliberated the issue and decided that Ethylene Dibromide is though banned for insecticidal use in the country, the import permit for its import shall be considered as import of a chemical in the Schedule meant for non-insecticidal use. Therefore, the case may be processed further accordingly. The Committee deliberated the issue in detail and decided to seek the particulars of the consignment as to who and what purpose has imported the consignment? On receiving the complete details of the consignment, the Committee will consider the issue for suitable decision. 15