Minutes of the 256th meeting of the Registration Committee held on 12th Sept. , 2005 in Committee Room No.139, Krishi Bhavan, New Delhi
The 256th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 12th Sept., 2005 at 1030 hrs. in Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. P.N.Maji, Addl. Industrial Adviser, Dr. T.P. Rajendran, Assistant Director General (PP), ICAR and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting.
Following officers from the Secretariat of CIB&RC were also present:
(i) Sh.Vipin Bhatnagar, Jt.Dir.(Chem.)
(ii) Dr. Ravi Prakash, JD (Bio)
(iii) Dr. R.M. Shukla, DD (Ent.)
(iv) Dr. Subhash Kumar, Agro (H)
(v) Smt. Kanta Arora, AO (CIB&RC)
(vi) Sh. Rajmant Singh, Section officer
(vii) Sh. Niraj Kulshrestha, Assistant(Legal)
(viii) Dr. Mukul singh, DD(Med)
At the outset the Chairman welcomed the participants and requested Secretary,CIB&RC to take up Agenda for discussions. The following decisions were taken:
Agenda ItemNo.1.0 / Confirmation of minutes of the 255th meeting of the Registration
Committee
The minutes of the 255th meeting of the Registration Committee were confirmed.
Agenda ItemNo.2.0 / Follow up action on the decisions taken by the Registration Committee in its 255th meeting.
The Committee noted the follow up action on the decisions of the Registration Committee (RC) and appreciated the efforts of the Secretariat of CIB&RC in issuing the certificates of registration of approved applications under various categories.
Agenda ItemNo.2.1 / Application pending under various Sub-sections of the Insecticides Act,1968.
The Committee noted the applications pending under various sub-sections of the Insecticides Act.
Agenda ItemNo.3.0 / Government Business
Agenda Item
No.3.1 / Import of formulated pesticides without registering the technical grade compound – representations from Pesticide Industry and Associations – reg.
The Agenda was deliberated in detail. A presentation was made by the Crop Care Federation of India on the issue of MRLs and import of formulation of pesticides without registering the technical grade compound wherein certain safety, technical issue and socio-economic consideration have been raised by the Crop Care Federation of India for permitting the import of formulated material without registering the technical. In view of this, the Committee decided to put the observations of the Crop Care Federation of India on the Website for comments by the interested parties and to bring the Agenda in the next Registration Committee meeting with the comments so received and the background for permitting the import of formulated pesticides without registering technical.
Agenda ItemNo.3.2 / Import of Boric Acid for non-insecticidal use – directive of DAC – reg.
The Committee noted the directives of the DAC regarding issue of import permissions for Boric Acid for non-insecticidal use. Secretary,CIB&RC also apprised that the DAC vide letter No.17-2/04-PPI (Vol.VI), dated Ist Sept.,2005 has directed to issue similar instructions for import of any/all insecticides capable of multi purpose end use. The Committee noted the information apprised by Secretary,CIB&RC.
Agenda ItemNo.3.3 / Preliminary scrutiny of all applications for registration of pesticides for all categories u/s 9(3), 9(3B), 9(4), Export and endorsement.
The Committee provisionally approved the Check List for preliminary scrutiny of applications for registration of pesticides under various categories, i.e. 9(3),9(3B),9(4), Export and Endorsement.
Agenda ItemNo.4.0 / Export cases
Agenda Item
No.41 / Consideration of application of M/s Nagarjuna Agrichem Ltd. for grant of registration of indigenous manufacture of Thifluzamide technical (Fungicide) under Section 9(3) for export only.
Approved
Agenda ItemNo.4.2 / Consideration of application lof M/s Godrej Saralee Ltd. for grant of registration for indigenous manufacture of Fenitrothion 2% dust + Pyriproxyfen 0.05% w/w Cockroach Bait HH (Insecticide) under Section 9(3) for export only
Approved.
Agenda ItemNo.4.3 / Consideration of application of M/s Parijat Agencies for grant of registration for indigenous manufacture of Quizalfop Ethyl tech. (Herbicide) under Section 9(3) for export only.
Approved.
Agenda ItemNo.4.4 / Consideration of application of M/s Bayer CropScience Ltd for grant of registration for indigenous manufacture of Ethoprophos tech. (Insecticide) under Section 9(3) for export only.
The Committee noted that there are considerable variations in the acute dermal LD50 indicated under Col.II in the Agenda is 1280mg/Kg (M) and 424mg/Kg.(F) as per the information submitted by the applicant and as reported in the WHO Classification of Pesticides by Hazards, and the product has been categorized in 1A category with dermal LD50 value of 26mg/Kg. In view of this, the Committee did not approve the application and desired to seek clarification from the applicant in this regard.
Agenda ItemNo.5.0 / 9(3B) Cases
Agenda Item
No.5.1 / Consideration of application of Directorate of Oilseeds Research, Hyderabad for grant of registration for indigenous manufacture of Bacillus Thuringiensis kurstaki var. H 3a, 3b, 3c 0.5% WP under Section 9(3B)
Approved for a period of two years with commercialization.
Agenda ItemNo.5.2 / Consideration of application of M/s M.S. Industries, Amravati (MS) for grant of registration for indigenous manufacture of Trichoderma Viride 1% WP under Section 9(3B)
Approved for a period of two years with commercialization.
Agenda ItemNo.5.3 / Consideration of application of M/s United Phosphorus Ltd., Mumbai for granting provisional registration lof Pyrazosulfuron ethyl tech. For import and Pyrazosulfuron ethyl 10% WP for indigenous manufacture u/s 9(3B) without commercialization for data generation.
Approved.
Agenda ItemNo.5.4 / Consideration of application of M/s Omega FineChemicals, Mumbai for registration of CPPU (Forchlorfenuron) technical and 0.1% liquid formulation under Section 9(3B).
The Committee deliberated the agenda in detail and observed that indigenous manufacture of Forchlorfenuron technical and its formulation 0.1% LS with commercialization has been permitted by the RC about 2 years back. During the first year, i.e. 2003-04 it was too late for the firm to manufacture the product as the grape growing season had already begun. As such the applicant was not able to undertake field tests data generation during first year of registration. The directives of the DAC regarding acceptance of 9(3B) application was also pointed out which states that no pesticide shall be registered for use without prior fixation of its MRL. The Committee deliberated the Agenda at length and decided that in view of the fact that the applicant is the only indigenous manufacturer of the product and it is a valuable import substitute for Indian grape growers at competitive lower prices, it may be permitted to manufacture CPPU tech. and its formulation under Sec.9(3B) for one more year with commercialization in the broader interest of farming community. The Committee further decided that in view of the directives of the DAC, it may be requested to accord permission/approval for extension of the earlier Certificate of Registration under Sec.9(3B) for commercialization of CPPU for one more year.
Further, regarding request of the applicant for waiver of toxicity data, it has been decided to constitute a Group under the Chairmanship of Dr.Y.K.Gupta, Professor & Head, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi. The names of other members of the Group will be put up on file to the Chairman,RC for approval by the Secretariat of CIB&RC.
Agenda ItemNo.6.0 / 9(3) cases
Agenda Item
No.6.1 / The applicant M/s V. Bhatia International have applied for registration of Cypermethrin 1% dust for public Health purpose under Section 9(3) of the Insecticides Act,1968.
The Committee deliberated the Agenda in detail and felt that the safety concerns as raised by the RC in its earlier meeting due to use of Cypermethrin 1% dust in household have not been adequately addressed and therefore did not approve the application.
Agenda ItemNo.6.2 / Consideration of application of M/s Bayer Crop Science, Mumbai for grant of registration for inmdigenous manufacture of Oxadiargyl technical (Herbicide) under Section 9(3)
Approved, subject to fixation of tolerance limits by Ministry of Health & Family Welfare.
Agenda ItemNo.6.3 / Consideration of application of M/s Bayer Crop Science, Mumbai for grant of registration for import of Bendiocarb technical and indigenous manufacture of its Bendiocarb 80% WP formulation (Insecticide) under Section 9(3).
Approved.
Agenda ItemNo.6.4 / Consideration of application of MJ/s Atul Limited, Gujarat for grant of registration for indigenous manufacture of Clodinafop propargyl technical (Herbicide) under Section 9(3)
Approved.
Agenda ItemNo.6.5 / Consideration of application of M/s Bayer Crop Science India Limited for grant of registration for import of Mesosulfuron-methyl 3% + Iodosulfuron methyl sodium 0.6% WG (Herbicide) U/s 9(3) without registering of technical.
Approved, subject to fixation of tolerance limit by Ministry of Health & Family Welfare.
Agenda ItemNo.6.6 / Consideration of application of M/s Excel Industries Ltd., Mumbai for grant of registration for indigenous manufacture of combination product of Endosulfan 35% + Cypermethrin 5% EC formulation (insecticide) under Sec.9(3).
The Committee deliberated the information received from ADG(PFA) and was of the opinion that MRL fixed in Oilseeds cannot be considered for Cotton. Cotton seeds are mostly used as cattle feed. In view of this, the Committee desired to inform ADG(PFA) with the request to fix MRL on Cotton seed for Cypermethrin.
Agenda ItemNo.7.0 / Applications for registration under Section 9(4)
The Committee approved the applications for which MRL is fixed, partially fixed or not required.
Agenda ItemNo.7.1 / Consideration of an application of M/s Krishi Rasayan (P) Ltd, Kolkata under Section 9(4) for grant of registration of Ethephon Technical for indigenous manufacture.
Approved.
Agenda ItemNo.7.2 / Consideration of an application of M/s Parijat Agencies, New Delhi under Sec.9(4) for grant of registration of Imidacloprid Technical for indigenous manufacture.
Approved.
Agenda ItemNo.7.3 / Consideration of an application of M/s Punjab Chemicals & Pharmaceuticals Limited, Chandigarh under Section 9(4) for grant of registration of Imidacloprid Tech. For indigenous manufacture.
Approved.
Agenda ItemNo.7.4 / Consideration of an application of M/s Tagros Chemicals India Limited, Chennai under Sec.9(4) for grant of Registration of Permethrin Tech. For indigenous manufacture.
Approved.
Agenda ItemNo.8.1 / Endorsement cases.
AND
Ex-post facto approval for import permits issued.
Approved.
Agenda ItemNo.8.2 / Consideration of extension of bioefficacyclaim of Milbemectin 1% EC in favour of M/s Nagarjuna Agri. Chem. Ltd., Hyderabad.
The Committee deliberated the Agenda in detail and noted that waiting period of 7 days has been suggested for use on chillies, which seems longer considering the harvesting pattern of chillies. In view of this, the Committee decided to obtain the comments of ADG(Horticulture) and ADG(PP) on the waiting period/residue data submitted by the applicant.
Agenda ItemNo.8.3 / Additional pack size for Carpropamid 27.8% SC – proposed by M/s Bayer Crop Science Ltd.
Approved.
Agenda ItemNo.8.4 / Consideration for approval of protocol for generation of shelf life data of impregnated long lasting insecticidal net containing Permethrin 2% w/w.
Approved in principal. However, the Committee authorized the Expert in the Secretariat of CIB&RC to satisfy regarding the details submitted by the applicant regarding the methodology and the periodicity of analysis.
Agenda ItemNo.8.5 / Approval of Protocols.
Approved.
Agenda ItemNo.8.6 / Endorsement of additional pack size of the approved packaging material for Tricyclazole 75% WP – proposed by M/s Nagarjuna Agrichem Ltd., Hyderabad.
Approved.
Agenda ItemNo.8.7 / Consideration of Extension of Bioefficacy claim of Spinosad 45% SC in favour of M/s De-Nocil Crop Protection Pvt. Ltd., Mumbai.
Approved, subject to fixation of tolerance limits by the Ministry of Health & Family Welfare.
Agenda ItemNo.8.8 / Request of M/s United Phosphorus Ltd. for providing some time to make a demonstration to the Registration Committee before the application of Cypermethrin 3% Smoke Generator for general public.
The Committee agreed to the request of M/s United Phosphorous Limited to make demonstration/presentation to the Registration Committee regarding their request for permitting use of Cypermethrin 3% Smoke Generator by general public.
Agenda ItemNo.9 / Any other item with the permission of the Chair.
A presentation was made by the Crop Care Federation of India on the difficulties faced by the Industry in fixation of MRLs. In the presentation, the present procedure adopted for fixation of MRLs in India was compared with reference to the procedure in Codex and in other countries and it was opined that preventing risks to human beings or animals in use of insecticides is the objective of the Insecticides Act and the Insecticides Rules provide for advising tolerance limits for insecticides by Central Insecticides Board. Further, the Prevention of Food Adulteration Act & Rules do not provide for fixation of MRLs but only provide for its Notification. The undue delay of more than 2 years forfixation of MRL of Hexaconazole on potato, chillies and grapes inspite of sending comments on draft Gazette Notification under the PFA by the registrant was brought to the notice of the Committee.
The presentation was also made w.r.t. the issue of import of formulation of pesticides without registering the technical grade compound wherein certain safety, technical issue and socio-economic consideration have been raised by the Crop Care Federation of India for permitting the import of formulated material without registering the technical grade compound and the Association re-iterated that registration of technical grade pesticides should be the pre-requisite for registration of their formulation.
Guidelines for registration of formulation for import from a new source:
Secretary,CIB&RC apprised the Members that a query has been received in the Registration Secretariat for the data requirements for import of formulation from new source by M/s PNP Associates Pvt. Ltd. As on date, no guidelines under this category exist. The Committee decided that the issue of import of formulation without registration of technical grade pesticides is under consideration of the RC and, therefore, this issue may be discussed along with the said issue on receipt of comments of interested parties as indicated under Agenda Item No.3.1.
The meeting ended with a vote of thanks to the Chair.
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