PESTICIDE RISK ASSESMENT AND MANAGEMENT IN TURKEY

Transcription

1 PESTICIDE RISK ASSESMENT AND MANAGEMENT IN TURKEY Sakine UGURLU, PhD MINISTRY OF AGRICULTURE AND RURAL AFFAIRS ANKARA PLANT PROTECTION CENTRAL RESEARCH INSTITUTE ANKARA 1-3 July GENEVA -SWITZERLAND Nutrition is one of the most important problem in the world. Increasing the product per area, is one of the first aims in agriculture. During the production if you do not use control precautions against diseases, pests, and weeds there will be about 65% production losses. Chemical protection is the most powerful method in this area. 1

2 There are different climates and different agro-ecologic areas, where many kinds of crops grow, from cereals to citrus, vegetables to tea in Turkey. As a result of this, Turkey is a very rich country in crop types. More than 60 kinds of cultural-crops, which has economic importance, are grown in Turkey. Consumption of plant protection product is mean 50,000 tones/year in Turkey. This amount includes 47% insecticides, 24%herbicides, 16% fungicides and 13% of other groups 2

3 Plant Protection Product Consumption of Regions in Turkey Black Sea R. 11% Southeast Anatolia R. 8% East Anatolia R. 4% Mediterranean R. 22% Marmara R. 17% Central Anatolia R. 20% Aegean R. 18% Mediterranean R. Central Anatolia R. Aegean R. Marmara R. Black Se a R. Southeast Anatolia R. East Anatolia R. RESTICIDE REGISTRATION PROCESS IN TURKEY Registration process are carried out by Ministry of Agriculture and Rural Affairs, General Directorate of Protection and Control There is a Directive of Registration concerning the method and principles of registration of plant protection products in Turkey. 3

4 The Directive covers the qualifications, duties and responsibilities of real and legal persons and instructions which will carry out the trials that will serve as a basis for registration procedure, the rule for granting a Trial Authorization, the trials on biological efficacy, phytotoxicity, residual effects and adverse effects. Registration processes are carried out according to this Directive Necessary Conditions for Registration Firms have to take Plant Protection Product Operating Permit (İştigal izin) before applying the Registration. Registration of plant protection products (PPPs) occurs in two ways: * Registration product for the first time (new active substance) * Registration on norm basis (authorized active substance) 4

5 1. Registration product for the first time If active substance take the registration for the first time in our country, owner of the applier applies to GDPC (General Directorate of Protection and Control) with all documents required in regulation for the registration. Owner of the applier could apply for the registration after carried out all required works for the active substance which has different formulation or different amount of active substance, even if active substance registered before. 2. Registration on Norm Basis It requires less information and documents than registration product for the first time. It is carried out with submitting documents required in regulation and documenting the active substance and formulation types which are as same as the norm basis. Registering on Norm Basis is executed when plant protection product s registration time, patent time and protection time has finished. 5

6 Commission Commission of Pesticide and Similar Substances Registration and Evaluation is comprised by General Directorate representatives, General Directorate of Agricultural Research representatives and Experts from Research Institutes. This commission comprises about 25 person and Deputy Director of GDPC presides it. Commission meet to negotiate issues of the day, at first Tuesday of every month. Evaluation of Registration Company s files for registration are investigated and evaluated by Pesticide and Similar Substances Registration and Evaluation Commission which is comprised by General Directorate of Protection and Control from General Directorate of Protection and Control Representatives, General Directorate of Agricultural Research Representative and Experts who work at Research Institutes. 6

7 PLANT PROTECTION PRODUCT TO BE REGISTERED Preparations containing ingredients included in the scope of definition of plant protection products are subject to registration. These are: a) Pesticides, b) Plant Growth Regulators (PGR) c) Insect Attractants d) Insect repellents e) Insect Growth Regulators (IGR) f) Bio preparation g) Plant Activators h) Product used for the treatment of physiological diseases. GENERAL PRINCIPLES IN REGISTRATION Registration will be made on the basis of formulation of pesticides and similar products. Re-registration is necessary if a change is made in the type of formulation or in the content of active material of a registered pesticide and similar product. A separate registration licences is required to be obtained from the Ministry in order to locally produce or imported a product that is imported or locally produced and already registered. Registration licences granted will remain valid for a period of 5 years. 7

8 For the first time registration of pesticides include new active substances it should have been registered in countries of European Union or G-8 or a document is presented indicating the manufacturer country has been placed in the first 3 major producer of pesticides containing this active substance. INFORMATION AND DOCUMENTS REQUIRED FOR THE NEW ACTIVE INGREDIENTS 1-Information about physico-chemical properties of plant protection product (Specification) 2-Toxicological and Eco-toxicological studies 3- Biological Efficacy Trial Reports 4- Residue sdudies 8

9 1-Information for active ingredients - purity, - colour, - odour, - phsical state, - melting point for solids - boiling point - solubility in water at 20 C - solubility in solvents, etc 2- Information for Formulation a) Photocopy of Plant Protection Product Engagement License issued by the Ministry, b) Specifications conforming to the norms of the Ministry (3 copies) c) Analytical methods d) Quality control data e) Manufacturing method of formulation 9

10 3- Secret Recipe 4- Toxicological Information 1) Acute toxicity studies 2) Short term toxicity 3) Long term toxicity Carcinogenic studies may be conducted concurrently with such studies. Otherwise, they should be conducted separately. 4) Mutagenic studies -Ames test - Cytogenetic test - Micronucleus test - DNA repair test 7) Reproduction studies (two generations in rats) 6) Neurotoxicity studies 7) Potentiation 9) Acceptable Daily Intake 10) Worker exposure studies 11) Observation on human 12) Poisoning symptoms and treatment 13) Literature relating to toxicological information 10

11 5- Ecotoxicological Studies 1-Contamination of air, waters and soil with the product, In this part, information and studies will be given as to the state of active ingredients and metabolites, degradation products, half-life in soil, absorbtion / desoption coefficient, risk of contamination of underground waters. 2- Vertebrates, a) Effects on birds (acute tox.and feeding studies) b) Effects on fishes, 3- Invertebrates - Earthworms - Parasites and predators - Honeybee - Effect on other non-target organisms, silkworm - Effects on Daphnia spp. and effects algae 4- Metabolism and bioaccumulation studies 5- Measures to be taken in applications as regards environmental health 6- Biological Trial Studies and Biological Information 7- If the product is already registered in other countries, labels used in those countries certified by concerned authority 8- Resistance studies 9- Residue studies 11

12 INFORMATION AND DOCUMENTS REQUIRED FOR NORM BASIS It is essential that at least five yerar should have been passed from the date of recommendation in order to consider a pesticides on norm basis. It should have the same physical and chemical properties with pesticides taken as an equivalent product. It should have the same formulation type and should contain the same active material at the same rate with the pesticide taken as an equivalent product. CONFIDENTIALITY Information identified as Confidential in documents submitted to the Ministry by the holders of registration licences can not be disclosed in any whatsoever. Such information will be kept at the Ministry as Confidential Information. 12

13 Cancellation of Registration Registration of plant protection products is given for 5 years. If the mentioned conditions as follows determined, registration will cancelled irrespective of the time. In cases that active substances are banned by international organizations because of harmful effects to human health and environment, They are warned in cases that registered pesticide or similar substance s formulations are changed without informing to Ministry but if the same thing determined for the second time, registration will cancelled. Results of pesticide residue analyses which are done by Ministry and found over the country maximum residue limit s (MRLs) warning is given, when it repeated again registration will cancelled. From end time of the registration to in two years time, if there is no application to prolonging this period, plant protection products' registration is cancelled without any warning. Plant protection products' registration is cancelled which are considered necessary to cancel as rules of Plant Protection Products Guide. 13

14 When resistance is seen, recommendation of that relevant subject will cancelled and removed from the label. Same person or organization even if under different trade name could not apply for registration of plant protection product which was cancelled before for two years. There is no question on registering or usage of plant protection product which is banned or restricted because of its toxicology at any country in the world. CONTROL OF PESTICIDES IN TURKEY Control on Complaints Market Control Factory Control (Manufacturing) Labeling Control Retailer and Wholesaler Control 14

15 REQUIRED CONDITIONS IN CONTROLLING Physico- chemical properties of samples must be same that of given before in specification It must be not harmful to the plants (not phototoxic) It must be effective for the harmful organisms but not plant growth. It must be the same label and prospectus approved before by the Ministry. Production and quality control units must be suitable other related units. SELLING CHANNELS OF PLANT PROTECTION PRODUCTS Plant protection products are transmitted to retailers by wholesalers of registration holder firms. Farmers buy plant protection products that they need from these retailers and apply it according to recommendations of the Ministry. 15

16 There are about 372 registered active substance in Turkey. There are approx registered PPPs and 70% of these are found on the market in Turkey. TRAINING RELATED TO RISK REDUCTION There are training programmes for personnel of the Ministry working in the Plant Protection Departments regularly in each year. There is a Directive Pesticide application procedure and principles There is a Recipe Directive There is a Directive Recording of Using Pesticides in Turkey. There is some sdudies Hormonization of Annex 1 (91/414/EEC) 16

17 RESIDUE MONITORING There is National project related to Determination of Maximum Residue Limits in Turkey. The studies going on related to Standard of Supervised Trials on Pesticide residue. Harmonizing MRLs to EU PROBLEMS RELATED TO USING OF PESTICIDES There is some problems related to use of pesticides: Un-recommended use of pesticides Residuel alarms on some crops exported to other countries 17

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