Pesticides Control Regulations, 1984

Pesticides Control Regulations THE UNITED REPUBLIC OF TANZANIA THE TROPICAL PESTICIDES RESEARCH INSTITUTE ACT, 1979 (No.18 OF 1979) Mode under section 41 PESTICIDES CONTROL REGULATIONS, 1984 Short title 1. This Regulations may be cited as the Pesticides Control Regulations, 1984. Interpretation Acts, 1979 No.18 2. In these Regulations, unless the context otherwise requires “Act means the Tropical Pesticides Research Institute Act, 1979; “Chairman” means the Chairman of the Pesticides Approval and Registration Technical Committee who is also the Director of the Institute; “Committee” means the Pesticides approval and Registration Technical Committee established under section 13 of the Act ; “Compounding” means mixing of pesticide ingredient with another ingredient including diluents; “form” means a form set out in the Schedule to these Regulations; “formulating” means prescribing and, or mixing pesticide ingredient according to a particular formulae; “Institute” means the Tropical Pesticides Research Institute; “laboratory” means the Pesticides Registration and Control analytical laboratory at the Institute or the laboratory of any analyst appointed under section 21 of the Act; “label” means any written, printed or graphic matter on the immediate container and on every other receptacle or package in which the container is placed or packaged. “manufacture” in relation to any pesticide includes – any process or process or part of a process for making, altering, finishing, packing, labelling, breaking up or otherwise treating or adopting any pesticide with a view to its safe, distribution or use, and includes any process of formulating and compounding such pesticides; Pesticides Control Regulations “package” means a receptacle or wrapper in which a pesticide container is placed or packaged during storage of transportation. “premise” means any land, shop, rail or place where any pesticide is sold or manufactured or stored or used and includes any vehicle carrying pesticide; “sale” means a sale of any pesticide, whether for cash or on credit and whether by wholesale or retail, and includes an agreement for safe, an offer for sale, the exposing for sale or having in possession for sale of any pesticide and includes also an attempt to sell any such pesticide; “Schedule” means a schedule annexed to these Regulations. 3. The objects of these Regulations are (i) to ensure the effectiveness if pesticides used in Tanzania for the production of food and fibre and for the protection of public health and safety; (ii) to promote against possible harmful effects of pesticides including: (a) impartment of the health of persons handling pesticides or using or consuming products or substances treated with pesticides; (b) impairment of the health of domestic animals including honey bees from direct application of pesticides of from the consumption of plant; or animals treated with pesticides; (c) damage to cultivate plants from direct application of pesticides or from persistent soil reduces; and (d) damage to the natural environment including impartment of the health of wildlife and contamination of waterways, lakes and other water bodies. Objects 4. The Committee shall consist of the following members namely (1)- (a) The Director of the Institute; (b) the Analyst in charge of the Pesticides Registration and Control analytical Laboratory; (c) the Director of Research, Ministry of Agriculture; (d) the Registrar of the Pharmacy Board, Ministry of Health; (e) the Chief Government Chemist, Ministry of Health; (f) one person each representing (i) the Tanzania Bureau of Standards (TBS); (ii) the University of Agricultural, Morogoro; (iii) the Ministry of Agriculture and Livestock Development; (iv) the National Chemical Industries; (v) the Tanzania Agricultural Research Organization (TARO); (vi) the Tanzania National Scientific Research Council; (vii) the Tanzania Livestock Research Organization . (2) The Committee may also co-opt such number of experts and for such purposes or periods as it may deem fit but any expert so co-opted shall have Compos of the Commit Pesticides Control Regulations no right to vote. (3) No member of the Committee shall, while holding such membership, engage directly in any trade or business concerned with importation, manufacture, distribution or sale of any pesticide. Tenure and procedure of the Registration Committee 5. – (1) The person nominated under clause, (i (g) (i)-(vii) inclusive of Regulation 4 shall, unless their seats become vacant either by resignation, death or otherwise, hold office for three years from the date of their nomination but shall be eligible for re-nomination. (2) The person nominated under paragraph (a) to (h) shall hold office only, for as long as they hold the appointment by virtue of which their nomination were made; (3) The Committee shall regulate its own procedure and the conduct of business to be transacted by it. Functions of the Committee 6. The Committee shall in addition to the functions assigned to it by the Act, perform the following functions, namely (i) to maintain a system of collaboration with any national or international body or person dealing with pesticides; (ii) maintain system of cooperation with licensing and tendering authorities; (iii) to perform such other incidental or consequential matters necessary for carrying out the functions assigned to it under the Act or these Regulations, Procedure for importation of a pesticide 7. – (1) Every person importing a pesticide shall obtain a permit for importing that pesticide, from the Registrar. (2) The application for a permit and the permit shall be issued in the from set out respectively in Schedule II and III. (3) Every importer of a pesticide shall pay a cost of 0.5% of the FOB value of the pesticide to be imported. (4) Any cess paid under this Regulation shall be refunded the Institute where it is shown to the satisfaction of the Registrar that the pesticide in respect of which the cess was paid, was not, for any reason subsequently imported. Every Pesticide in use to be registered 8. Every person who, for commercial purposes or for disposal in any way for use by the public, imports, manufactures, formulates or compound any pesticide shall register that pesticide in accordance with the Act and these Regulations. Procedure for registration of a pesticide 9. Every application for pesticide registration or renewal of registration shall be on a form specified in Schedule 1 to these Regulations and shall, unless otherwise advised be accompanied by (a) a doser containing additional information to determine the Pesticides Control Regulations suitably of the pesticide as to it’s use and including technical data sheet and direction on how to detect and quantitate the active ingredient; (b) the appropriate application fee; (c) a representative sample of the pesticide, certificate of analysis, if already issued, and a written declamation that the pesticide has or has not been banned or restricted in the country of origin. 10. – (1) A sample submitted for analysis for the purposes of registration shall be accompanied by appropriate standards. (2) A sample submitted for analysis shall not be less than 0.5 kilogram in case of solids, or not less than 0.5 litres in case of liquids. (3) The container in which a sample for analysis is packed shall be sealed and adequately labelled. (4) Every sample submitted or analysis shall be accompanied with the specifications of the sample and other relevant information. Submission and analysis of samples 11.- (1) Every pesticide submitted for registration shall be submitted for testing by the Registrar or by a person authorised by him and the Registrar of the authorized person as the case may be, shall carry out such field and/or laboratory tests as are necessary to determine the suitability for use of the pesticide. (2) Where the testing is carried out by a person other then the Registrar, that person shall submit, as soon as the test is completed the results of the test to the Registrar. Testing of pesticides 12.. The person applying for registration of a pesticide shall satisfy the Registrar that (a) the premises for the storage of the pesticide are adequate and well equipped with proper storage accommodation for avoiding any hazards and for preserving the properties of the pesticide in respect of which a registration certificate is sought; (b) there will be a person or persons on the technical staff of the person applying who is or are qualified or experienced in handling the pesticide. Additional conditions for registration 13.- (1) If the Registrar is satisfied that a person applying for re Registration of a pesticide has complied with the provisions of the Act and these Registrations he may register the pesticide. (2) On registration the person applying for registration of a pesticide shall pay such fees as are provided under these Regulations. (3) The Registrar may refuse to register a pesticide if he is not satisfied in terms of sub-paragraph (1). (4) An appeal from a decision of the Registrar refusing to register a pesticide under sub-Regulation (1) shall lie to the Minister and the Minister’s decision shall be final. (5) Every appeal under sub-Regulation (4) shall be made within sixty days Registration Pesticides Control Regulations from the date of the decision of the Registrar. 14.- (1) If the Registrar approves registration he shall issue a certificate of registration in a form prescribed in Schedule VI in respect of the pesticide whose registration is sought. Every certificate for registration shall expire after five years. Certificate of registration Provisional registration 15.- (1) Where by reason of non-compliance with any provisions of these Regulations or any direction given by him, the Registrar is unable to register a pesticide but is satisfied that steps can be taken with diligence by the applicant to comply with such provision of direction, as the case may, he may in his absolute discretion, by notice in writing (hereinafter referred to as a notice of deferment), defer registration of that pesticide pending compliance with such provision or direction. (2) The Registrar shall transmit the notice of deferment to the person who applies for registration of the pesticide. (3) A notice of deferment shall, subject to the provisions of this Regulation and any condition specified in that notice, entitle the person applying for the registration of a pesticide to use or dispose for use by the public the pesticide. (4) Every provisional registration shall expire after two years. 16. - (1) Where a pesticide is highly toxic, persistent, biologically cumulative or where that pesticide may cause a poisoning of which no effective antidate is known and available, the Registrar may register that pesticide subject to such conditions and restrictions as to its use or the quantity to be disposed of and other conditions that he may deem necessary. (2) Every registration of a pesticide for restricted use shall expire after two years. ……… experimental purposes 17. - (1) A person who intends to use a pesticide for experimental purposes shall have that pesticide registered in accordance with these Regulations. (2) Every registration of a pesticide for experimental purposes shall expire after one year. Fees 18 - (1) The fees payable for registration of a pesticide shall be – (a) full registration: shillings 3,000/=; (b) provisional registration: Shillings 2,000/= (c) restricted use registration: shillings 2,000/= (d) registration for experimental use: Shillings 300/= (2) A fee of shillings 1,000/= shall be charged for analysing a sample submitted for analysis as required under these Regulations. Payments of fees by non resident in foreign currency 19. A person who is non-resident and applies for registration of a pesticide shall pay any registration fee required to be paid in equivalent but negotiable foreign currency. Pesticides Control Regulations No alteration of a pesticide unless approved 20. - (1) No person may use or after the character of a registered pesticide for commercial purposes or for disposal in any way to the public unless the alteration is approved by the Registrar. (2) An application for clearance to use a registered pesticide for commercial purposes shall be made and issued on the forms set out on Schedule IV and V respectively. 21. Manufacturers and formulators of pesticides within Tanzania shall maintain a quality control laboratory or engage a recognised laboratory to check the quality of their finished products and must test and keep records of their products prior to releasing them for distribution and use. Manufactures etc to maintain quality control Laboratory 22.Lisencing authorities shall only issue trading licences to persons intending to carry out pesticide business including manufacturers, distributors, formulators, fumigators, and other pest controllers, etc. after such persons have produced a written approval or registration certificate from the Registrar. Evidence of registration before issue of licence 23.Every registrant shall make records of all quantities of a pesticide product manufactured, imported, stored, used or sold by him and the records shall (i) be maintained for at least five years from the time it is make; (j) be made available to the Registrar annually; (k) include type of pesticide origin, port of entry; quantity imported and sold, purpose, etc. Pesticide Records 24. Notwithstanding the provisions of section 20 (1) of the Act the label shall contain the following additional information (i) batch number, description of physical form and purpose of the pesticide and shall include the common name of its active ingredient and trade mark or commercial name; (ii) the essential instructions or directions on the use of the product in both English and Swahili languages and shall include (a) a statement of the intended use for the product, listing the crop and the pest situation for which it is officially registered or approved; (b) information on recommended dosage rates, methods and timing of application for the above use; (c) information on compatibility with other products or substances which may be proposed for use with the contents; (d) a phrase stating the category and limitations of use of the product eg. FOR USE ONLY AS HERDICIDE, also it should include a brief statement summarizing the main biological uses of the product for example, “For pre-emergent control of annual and broad-leaved weeds in cotton”; Labelling Pesticides Control Regulations (e) expiry date for the product or the date of manufacture and the shelf-life, (f) any warnings contra-indications intended to prevent misuse of the product and safety of users including practical antidote in case of accidental poisoning; (g) any special recommendations on storage conditions for the container and product. Directions for use shall be included on the main label on the container but may be supplied as a separate “Directions for Use” leaflet with each container or outer package. Use of graphics to convey relevant pesticide information may appear on the label; (h) the warning “SUMU (POISON)” written in bold red letters should appear at the top-centre of the label together with the skull and cross-bone drawing; (i) all bulk purchases shall bear a label as provided for in those Regulations, and shall further be accompanied by a document detaining the contents of label. Where the end product is in small packs must be labelled accordingly; (j) any additional information which cannot be accommodated on the label shall be include on the “directions for use” leaflet, for example practical advice on methods of preparing and using the product first aid and antidotes in case of poisoning and other necessary warnings. (iii) All the information on the label shall be accurate and fee from any statements which cannot be substantiated or which could fairly inform a purchaser or user. The label shall not describe a product by such terms as “Harmless, non-toxic, the best, superior or most effective”. 25. Any organization handling pesticides shall provide their handlers with base protective fare such a face-masks , goggles, aspirators, rubber gloves plastic or rubber aprons, rubber boots, overalls and caps. 26.- (i) Pesticides shall be packaged in clean and dry containers designed to provide protection against product deterioration, compaction, weight change or other spoilage. Containers must withstand all anticipated level of handling, storage, stacking, loading and unloading conditions and should not become adversely affected by changes in atmospheric conditions, pressure, temperature and humidity; (ii) no pesticide shall be transported or stored on such a way that it can easily come into contact with food or foodstuff; (iii) all pesticide storage areas shall be clearly marked with warning signs and the labels n the containers positioned so that they are clearly visible. Such an area shall be kept locked to avoid access of unauthorized persons; well ventilated and provided with fire Pesticides Control Regulations fighting equipment. 27. - (i) Registrants shall be required to supply information on the safest and most practical way or ways of disposing any unwanted quantities of pesticides with the least possibility of polluting the environment; (iii) Registrants shall supply information on the safest and most practical ways of decontaminating and disposing of any used pesticide containers, with the least possibility of polluting the environment. 28. (1) Upon the coming into operation of these Regulations any person engaged in the business of import or manufacture or sale of any pesticide, whereby that pesticide is not registered, shall within three months apply to the Registrar for registration of that pesticide. (2) Where an application is made in terms of sub-Regulation (1) of this Regulation, the Registrar may grant provisional registration in respect of the pesticide and the application of Regulation 15 shall apply mutates mutandis in respect of that pesticide. SCHEDULES I FORM PRC-1 CONFIDENTIAL TROPICAL PESTICIDES RESEARCH INSTITUTE ARUSHS – TANZANIA FOR OFFICIAL USE The Registrar. Application No……………………………. Pesticides Registration and Control. Date Received: ……………………………. P.O. Box 3024. Fees Receipt No:…………………………… ARUSHA, Tanzania. Rejection letter Ref. No……………………. APPLICATION FOR PESTICIDE REGISTRATION (Under Regulation 9) (To be filled in Triplicate) 1. Application’s Details: (a) Name ......................................................................................................................... Pesticides Control Regulations (b) Address...................................................................................................................... (c) Address in Tanzania if different from above ............................................................ ................................................................................................................................... (d) Type of Organisation (Importer, Manufacture, Distributor etc.) .............................. ................................................................................................................................... (e) Name and address of Manufacturer/Importer of the original pesticide .................... ................................................................................................................................... (f) Name and address of firm’s consultants ................................................................... ................................................................................................................................... 2. Details of the Product: (a) Common name(s) of the Pesticide ............................................................................ ................................................................................................................................... (b) Trade name(s) or code number of the Pesticide........................................................ ................................................................................................................................... (c) Chemical name(s) of the Pesticide (a i) .................................................................... ................................................................................................................................... (d) Molecular formulae of the a I(s) ............................................................................... ................................................................................................................................... (e) Molecular weight....................................................................................................... ................................................................................................................................... (f) Structural formulae of the a I .................................................................................... ................................................................................................................................... (g) Main active ingredient(s) .......................................................................................... Content by weight/volume ........................................................................................ (h) List of adjuvant name(s)............................................................................................ Content by weight/volume ........................................................................................ (i) Type of Pesticide (e.g weed killer)............................................................................ ................................................................................................................................... (j) Type of Formulation eg. Wettable powder ............................................................... ................................................................................................................................... (k) Physical properties: (i) Solubility of the pesticide in aqueous and/or organic solvents (metric units)........................................................................................................ ................................................................................................................. (ii) Emulsifiability/suspensibility (or emulsion stability) ............................. ................................................................................................................. (iii) Physical description (e.g. colorless crystals)......................................... .............................................................................................................. (iv) Wettability............................................................................................... ................................................................................................................. (v) Stability/comparability (eg. hydrolysed by alkali) .................................. ................................................................................................................. (vi) Spraying/dusting properties..................................................................... (vii) Moisture content...................................................................................... (viii) Melting point ........................................................................................... Pesticides Control Regulations (ix) Setting point ............................................................................................ (x) Boiling point............................................................................................ (xi) Vapour pressure....................................................................................... (xii) Accelerated storage ................................................................................ (xiii) Flammability, etc..................................................................................... (xiv) Active ingredient by weight/volume....................................................... ................................................................................................................. (xv) Acidity/Alkalinity.................................................................................... (l) Tolerance limits for the characteristics in (k) above (where applicable) .................. ................................................................................................................................... (m) Estimated quantities of the product marketed during the last two years and the current year................................................................................................................ ................................................................................................................................ 3. Give a summary of the Product’s Toxicology and other side effects: (a) Classification (in accordance with the WHO guidelines)............................................. ...................................................................................................................................... ...................................................................................................................................... (b) Decimal and oral mammalian toxicity (LD) ................................................................. ...................................................................................................................................... ...................................................................................................................................... (c) Two weeks cumulative mammalian toxicity of the Product......................................... ...................................................................................................................................... ......................................................................................................................................