Minutes of the 274th meeting of the Registration Committee held on 21st March, 2007 in Room No.139 ,Krishi Bhawan, New Delhi The 274th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 21st March, 2007 at 1030 hrs. in Krishi Bhavan, New Delhi. Dr.P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. T.P.Rajendran, Assistant Director General(PP), ICAR, Shri P.N. Maji, Addl. Industrial Advisor, M/o. Chemicals & Petrochemicals, Shri Madhab Chakraborthy, Deputy Director, Indian Institute of Packaging, New Delhi ( Co-opted Member), Dr. P.S. Chopra, ADG(PFA) and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting. Following officers from the Secretariat of CIB&RC were also present: (i) Dr. Hari Prasad, Jt.Dir.(Chem.) (ii) Dr. R.M. Shukla, DD (Ent.) (iii) Dr.Subhash Kumar, Dy.Dir.(WS) (iv) Sh. R.C.Gulati, SO (v) Sh. Niraj Kulshrestha, Assistant(Legal) (vi) Sh. Y.S. Adhana, SSA-III 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 273rd meeting of the Registration Committee. The Minutes of the 273rd meeting of the Registration Committee (RC) were confirmed. Agenda Item No.2.0 Follow up action on the decisions taken by the Registration Committee in its 273rd meeting. The Committee noted the follow-up actions taken on the decisions of the Registration Committee. Agenda Item No.2.1 Applications pending under various Sub-Sections of the Insecticides Act, 1968 The Committee noted the pendency of the applications under various Subsections of the Act. Agenda Item No.3.0 Government Business Agenda Item No.3.1 Registration of Cypermethrin 3% SG for general public use : Decision of Appellate Authority. The Committee noted the decision of the appellate authority and decided to constitute a committee with the following composition to look into the request of the appellant to permit the use of Cypermethrin 3% SG for general use: 1. Dr.H.N. Saiyed - Chairman 2. Dr. Usha Gupta - Member 3. Dr. R.M. Shukla - Member-Secretary Agenda Item No.3.2 Decision in the Appeal of M/s Nahar Colours & Coating Ltd., Udaipur The Committee noted the decision of the appellate authority. Agenda Item No.4.0 Export Cases Agenda Item No.4.1 List of applications u/s 9(3) Export Approved. Agenda Item No.4.2 Consideration of an application of M/s Atul Ltd., Atul for grant of registration for indigenous manufacture of MCPA 315 g/l + 2,4-D 360 g/l Dimethyl Amine Salt S.L. (Herbicide) Approved. Agenda Item No.4.3 Consideration of an application of M/s United Phosphorus Ltd., Mumbai for grant of registration for indigenous manufacture of Picloram Technical (Herbicide) Approved. Agenda Item No.4.4 Consideration of an application of M/s Godrej Sara Lee Ltd., Mumbai for grant of registration for import of Metofluthrin Technical (Insecticide) Approved. Agenda Item No.4.5 Consideration of an application of M/s Godrej Sara Lee Ltd., Mumbai for grant of registration for indigenous manufacture of Metofluthrin 7.7% w/w Paper Emanator (Insecticide) Approved. Agenda Item No.4.6 Consideration of an application of M/s Atul Ltd., Atul for grant of registration for indigenous manufacture of Thifensulfuron Methyl Technical (Herbicide) Approved. Agenda Item No.4.7 Consideration of an application of M/s Krishi Rasayan Export Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Epoxiconazole Technical (Fungicide) Approved. Agenda Item No.4.8 Consideration of an application of M/s Krishi Rasayan Export Pvt. Ltd., New Delhi for grant of registration for indigenous manufacture of Ethofumesate Technical (Herbicide) Approved. Agenda Item No.5.0 9(3B) Cases Agenda Item No.5.1 Consideration of application of M/s Directorate of Oilseed Research (ICAR), Hyderabad for grant of registration for indigenous manufacture of Trichoderma Viride 1.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.2 Consideration of application of M/s Pruthvi Fertilizers Pvt. Ltd., Anand (Gujarat) for grant of registration for indigenous manufacture of Psuedomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda Item No.5.3 Consideration of application of M/s Pruthvi Fertilizers Pvt. Ltd., Anand (Gujarat) for grant of registration for indigenous manufacture of Trichoderma Viride 1.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.4 Consideration of application of M/s IPM Biocontrols Labs Pvt. Ltd., Secunderabad for grant of registration for indigenous manufacture of Psuedomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda Item No.5.5 Consideration of application of M/s Margo Biocontrols Pvt. Ltd., Bangalore for grant of registration for indigenous manufacture of Psuedomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda Item No.5.6 Consideration of application of M/s Poabs Envirotech Pvt. Ltd., Kerala for grant of registration for indigenous manufacture of Psuedomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda Item No.5.7 Consideration of application of M/s Poabs Envirotech Pvt. Ltd., Kerala for grant of registration for indigenous manufacture of Trichoderma Viride 1.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.8 Consideration of application of M/s Transgene Biotech Ltd., Andhra Pradesh for grant of registration for indigenous manufacture of Psuedomonas fluorescens 0.5% WP Approved for a period of two years with commercialization. Agenda Item No.5.9 Consideration of application of M/s Balaji Cropcare Pvt. Ltd., Rangareddy (AP) for grant of registration for indigenous manufacture of Trichoderma harzianum 2.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.10 Consideration of application of M/s IPM Biocontrol Labs, Secunderabad for grant of registration for indigenous manufacture of Trichoderma Viride 1.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.11 Consideration of application of M/s International Panacea Ltd. for grant of registration for indigenous manufacture of Metrahizium anisopliae 1.00% WP Approved for a period of two years with commercialization. Agenda Item No.5.12 Request for extension of validity period of provisional registration of Deltamethrin Impregnated Bed net u/s 9(3b) of M/s Vestergaard Frandsen (India) Pvt. Ltd., New Delhi The Committee deliberated the agenda in detail and decided to approve the extension of provisional registration u/s.9(3B) for a period of one year as commercialization within the already approved quantity of 6 million Impregnated Bed nets, subject to approval of competent authority DAC. Agenda Item No.6.0 9(3) Cases Agenda Item No.6.1 Reconsideration of application of M/s Syngenta India Ltd., Mumbai for grant of registration of Metalaxyl – M 31.8% ES for indigenous manufacture 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. Agenda Item No.7.2 Consideration of application of M/s Meghmani Industries Ltd. for grant of registration for indigenous manufacture of Propiconazole Technical Approved. Agenda Item No.7.3 Consideration of application of M/s Krishi Rasayan Pvt. Ltd. for grant of registration for indigenous manufacture of Gibberellic Acid Technical The Committee deliberated the agenda in detail and in view of the request of the applicant to exempt the MRL for Gibberellic Acid. It decided to ask the applicant and M/s. Sumitomo Chemicals, Mumbai to make presentation for exemption of MRL in the forthcoming meeting of the R.C. Agenda Item No.7.4 Consideration of application of M/s United Phosphorus Ltd. for grant of registration for indigenous manufacture of Pretilachlor Technical Approved. Agenda Item No.7.5 Consideration of application of M/s Crop Health Products Ltd. for grant of registration for indigenous manufacture of Pretilachlor Technical Approved. Agenda Item No.7.6 Consideration of application of M/s Insecticides India Ltd. for grant of registration for indigenous manufacture of Dichlorvos Technical Approved. Agenda Item No.7.7 Consideration of application of M/s Insecticides India Ltd. for grant of registration for indigenous manufacture of Alphacypermethrin Technical Approved. Agenda Item No.7.8 Consideration of application of M/s Insecticides India Ltd. for grant of registration for indigenous manufacture of Cypermethrin Technical Approved. Agenda Item No.8.0 Miscellaneous Items Agenda Item No.8.1 Consideration of application of M/s Rallis India Ltd., Bangalore for endorsement of additional source through their approved supplier in the certificate of Registration of Dimethoate Technical for import and change of name of source. Approved. Agenda Item No.8.2 Proposal of additional packing of Cartap Hydrochloride Technical for Import proposed by M/s Coromandal Fertilizers Ltd., Secunderabad The Committee deliberated the agenda in detail and decided to refer the file to Co-opted member for examination of the data/information submitted by the applicant. Agenda Item No.8.3 Consideration of application of M/s Syngenta India Ltd., Mumbai for label expansion of Metalaxyl M 4% + Mancozeb 64% WP Approved, subject to fixation of tolerance limit by M/o. Health & Family Welfare. Agenda Item No.8.4 Proposal of additional pack size of 150 ml cap for Pretilachlor 50% EC in PET containers proposed by M/s Syngenta India Ltd., Mumbai The Committee deliberated the agenda in detail and observed that 50 and 100 ml pack sizes are already approved and 150 ml pack size is not as per the IS Standards, hence the request of additional pack size of 150 ml was not approved. Agenda Item No.8.5 The Consideration of request for guidelines for registration of Rotenone by M/s AS Aquaculture Pvt. Ltd., Kolkata Committee decided to constitute an Expert Group to frame the guidelines for registration of Rotenone for use in pisciculture. The composition of group is as under:- i) Dr. P.S. Chandurkar, Plant Protection Adviser to GOI -, Chairman ii) ADG Fisheries, ICAR iii) Representative from CIFA, Bhuvaneshwar iv) Dr. R.M. Shukla, Member Sec y Agenda Item No.8.6 Request of M/s Syngenta India Ltd., Mumbai for Export of Profenofos in ISO Tank of 16000 to 20000 Ton capacity. The Committee deliberated the agenda in detail and approved the request of M/s.Sygenta for export of Profenofos in ISO Tank of 16,000 to 20,000 ton capacity with the condition to follow the rules and regulations under M/o. Surface Transport for transportation and IMDG guidelines. Agenda Item No.8.7 Request of M/s Bayer Crop Science Ltd., Mumbai for label expansion of Oxadiargyl 6% EC for controlling weeds in onion. The Committee deliberated the agenda in detail and noted that applicant has not submitted data with respect to the periodic residue study in onion and green onion and pre-harvest interval in green onion as per earlier decision of the RC. Hence, did not approve the application. Agenda Item No.8.8 Request for change in name of company in respect of Saga Biotech Pvt. Ltd. Approved. Agenda Item No.8.9 Approval of Protocols Approved. Agenda Item No.8.10 Ex-Post facto approval of export applications Approved. Agenda Item No.8.11 Ex-Post facto approval for import permits issued Approved. Agenda Item No.8.12 Issue of import permit for Boric Acid & Other substances for non-insecticidal use. The Committee decided as per the annexure Part I, II and III. Agenda Item No.8.13 Incorporation of Customer Care Numbers on Package The Committee deliberated the agenda in detail and decided that in view of the Notification No.GSR 425(E), dated 17.7.2006, under Weights & Measures (for Packed commodities 1977), the pesticides importers and manufacturers may write the Name, address, telephone Number and E-mail address of the person who can be or the office which can be contacted, in case of consumer complaints on labels and leaflets. The letters should be sent to the Pesticides Industry Association and State Department of Agriculture in this regard. Agenda Item No.8.14 Request of M/s Syngenta India Ltd., Mumbai for change of packaging condition for Export of Pretilachlor Technical and Pretilachlor 50% EC The Committee deliberated the agenda in detail and decided to incorporate the following conditions in all the 9(3) and 9(4) Certificate of Registration issued for manufacture/import for domestic consumption. In case of export, the packaging shall be as per the requirement of the importing country and conforming to IMDG guidelines. Agenda Item No.8.15 8.1 Deferred Agenda Item of 273rd RC Meeting 8.1 8.9 8.10 Agenda Item No.8.1 of 270th R.C. Meeting The Committee deliberated agenda in detail and constitute a Committee under the Chairmanship of Dr. P.M. Maji, Addl. Industrial Adviser, the other members of the Committee are as follows:- i) Head of Agriculture Division of IARI and Agricultural Chemistrey, IARI. ii) Dr.(Mrs.) G. Mukherjee iii) Shri Vipin Bhatnagar, JD(Chemistry) - Member-Secretary Agenda item No.8.9 of 270th R.C. Meeting The Committee deliberated the agenda and decided that file may be put up to the Co-opted Member, Shri Madhav Chakraborty for perusal of data/information provided by the applicant. Agenda item No.8.10 of 270th R.C. Meeting The Committee deliberated the agenda and decided that file may be put up to the Co-opted Member, Shri Madhav Chakraborty for perusal of data/information provided by the applicant. Agenda Item No.9.0 Any other item with the permission of the Chair. Agenda Item No.9.1 Correction in the name of product from Trichoderma Viride 1% WP to Pseudomonas Fluorescens 0.5% WP in agenda item 5.15 of 270th RC. Noted. Agenda Item No.9.2 Treatment of seeds imported in the country with unapproved/unknown pesticides ADG(PP) raised the issue that the seeds imported in the country do not contain any information regarding the pesticides used for treatment of these seeds. The Committee decided to request the DAC for taking appropriate action in this regard. Agenda Item No.9.3 Consideration of appliction of M/s. Aura Chem Pvt. Ltd., Mumbai for grant of registration for indigenous manufacture of Prallethrin Tech. u/s.9(4) – Agenda Item 7.2 of 270th RC held on 8.12.2006 The Committee noted that this agenda item was earlier discussed in 270 th meeting of the RC, wherein, it was decided to refer the matter to PPA to the Govt. of India for examination and comments in the matter. PPA presented the comments to the RC, informing, as under:“M/s. Aura Chem Pvt. Ltd., Mumbai vide their letter dated 17.4.2006 informed Shri Murli Dhar, PPO(Chem) about the stage-wise process/synthesis in the manufacture of Prallethrin Tech. in response to the letter dated 31.3.2006 issued by the PPA for drawal of in-process sample. Accordingly, four steps have been indicated in this synthesis process requiring total time of 24 hours. This is for the manufacture of 1 MT Prallethrin. The firm was asked for further details as to why there is difference in the time required for process when in-process sample was drawn. The information received from the firm. Accordingly, they have further clarified that the conditions of manufacture vary depending on the type of reactor used, size of the reactor, type of stirrer and its speed, speed of addition of reactants, mass of reaction and conditions set, etc. and that the difference in the manufacturing conditions prevail depending on the scale of manufacture. They have further indicated that they have used the same raw materials and followed the reactions as per earlier registrant to establish chemical equivalence with the earlier registrants. On further detailed discussion with the chemist of the firm, it has been indicated that two days’ time is required for completing one batch of commercial scale manufacture of 5 ton capacity, whereas 24 hours time is adequate for completing the process of synthesis of laboratory scale. The reason for lesser time required for laboratory scale is merely because of the small quantity of reactants required to be handled and the products to be washed/separated to reach the end point. Further, in the commercial scale manufacturing, the stirring is done at a fixed speed of approximately 120 rpm, whereas in the lab scale synthesis the laboratory magnetic stirrer with variable speed is used, as a result higher rpm could be used which can enhance the speed of reaction to certain extent. The chemist of the firm indicated during the discussion that they had undertaken this kind of lab scale synthesis with this time frame several times in their lab before the actual demonstration at the time of in-process sampling. The above explanation given by the applicant is quite logical. From the above it is clear that the synthesis carried out for the in-process sampling was complete which resulted in the desired final product with the purity of 95.26% compared to the minimum requirement of 90% as per earlier registrants as reported in the Analytical Test Report of CIL. Hence, the sample confirms to the physico-chemical requirements.” In view of the above, the Committee approve the above application for registration. The meeting ended with a vote of thanks to the Chair. ****** Annexure Part-I Decision of the Registration Committee on applications for import permit of Boric Acid Sl. Name of the Applicant (M/s) Approved(Quantity)/ No. Not Approved (Reason) 1 2 3 1. Borosil Glass Works Ltd, 288 MT Mumbai. 2. Gibraltar Glass & Ceramics Not approved because the Pvt. Ltd., Padra (Gujarat). recommendation from nodal Deptt. was not submitted, instead the company has submitted a recommendation from DIC, Vadodara, which can not be accepted. 3. Prime Ceramics Pvt. Ltd. -doGavasad-391 430.(Gujarat). 4. La Opala Solitaire, Kolkata 123 MT Part-II Decision of the Registration Committee on applications for import permit of Boric Acid (EXCEPT BORIC ACID) Sl. No. 1 1. 2. 3. 4. Name of the Applicant (M/s) 2 Aarti Industry Ltd. Mumbai Honeywala Industries, Alwar, (Rajasthan) Schott glass India Pvt. Ltd., Boraoda. La Opala Solitaire, Kolkata. Quantity Requested/Insecticide/ Purpose 3 175 MT Sodium Cyanide Not approved. The application was not in prescribed proforma. 480.80 MT Barium Carbonate 92.5 MT Barium Carbonate Part-III Representations for issuance of Import ermits for Dual Use Insecticides Sl. No. 1 1. 2. 3. 4. 5. 6. Name of the Applicant (M/s) 2 Sahaj Cerchem Private Ltd., Agra Bhanu Cerglazes Pvt. Ltd., Hyderabad. Nahar Colours & Coating Ltd., Udaipur Issue raised 3. Approved validity of permit up to July, 2007 Noted It was decided to ask the company to submit details as to how much quantity has already been imported so far against the cancelled certificate till date. Alongwith these information the company may submit fresh application as per guidelines. Orient Glazes Ltd., Radhy (Distt. Kheda Gujarat), Regd office in -doUdaipur. Chemi Enterprise, This representation may be sent to DAC. Mumbai. Karnataka Agro Not approved, as desired information regarding Chemicals, Bangalore. previous imports has not been given by the applicant.