Law of the Plant Protection, 1994

State Plant Protection Station Translation January 1995 LATVIA The Law of the Plant Protection REGULATIONS on Registration of Plant Protection Products in Republic of Latvia The L a. \.oJ or the Pla.nt Protec;t~on The Terms used in the Law Plant protection - a field of crop production. which studies the b I o Lo z Lca l and e co Lo a Lca l factors of harmful and cOlllPetitive o r z a n f s ma of crop. works out and performs restriction and control measures of these or~anlsms. Plant Protection Machinery especIally constructed and manufactured machinery (sprayers. aerosol generators. devices for work into the ground ~ranules of the pesticides. machinery for preparation the spray liquid and seed dressers etc.) for application of plant protection products. Plant protection product mechanical plant protection competitive or~anlsms of crop ne~ative influence. b f o f o z f c a l , chemical or physically product for control line harmful and and weed control or to decrease their Plant or~anlsms functions erowth of protection measures the lDan's effect on the harmful or initiators of the disturbance of physloloeical of the plants; to protect plants. to insure the normal them and not to allow the possible loss of the yield. Is &!ooes the Plant infestation the beclnninc of the disease which settin£. In with the entrance of phvtopathocen in the plant and on until stable parasitic relations are formed between phytopathocen and the host of parasite. Harmful oreanisms - pests of plant or plant products b e l on a t nz to the animal or plant kincdom. and also viruses. bacteria and mycoplasmas and other pathocens, weeds etc•• which directly or indirectly damace the plants or cause thair disease. thereby reduc1nc the crop yield. Pests any species. strain or biotype of pathocenlc acent which directly or Indirectly thereby reduclnc the crop yield and quality. plant. damace animal, or the plants. Prevalence of plant pests (diseases) occurance of the plant pests (pathocen acents) in an area In the definite tilDe period. Plant quarantine the State o r aan t z ed measures t.o secure the plant protection. don't allow to import and spread the quarantine objects and other particularly harmful or£,anlsms for plants which are determined by the correspondin~ state institutions. P I ant d igeases disturbance orcans or cells which is caused by phytophato~enic organisms (funeus. reducing the crop yield or causing of metabolism of the plant. Its unfavourable growth conditions or bacteria. viruse9 etc.). thereby their dalllace. Growth regulators the biologically active substance, which influenceg the plants ve~etatlon or development. 2 Environment - totality 01 the naturels factors which directly or indirectly aflect the human life and their economic activities. Funcicide - the che.ical substance for the control of the plant diseases initiated by funcus. Herbicide - the chemical product for weed control. Insecticide - the chemical product for insect control. Cultivated substrate - artificially formed substrate. Mycotoxin a product of the metabolism which durinc the life processes of the microscopic funcus. to plants. people and animals. has cropped up which is toxic Unparasitic plant disease - the disturbance of the physlo1ocical functions of the plants due to unfavourable conditions. The main factors which make the necative influence to the plant developnment are the metereolocical and soil conditions (the temperature. humidity. structure of the soil. the ensurinc with nutrients for plants e t cv ) , as we II as choice of the pI ace of cui ti vatlon and aloncside plants. Pesticide a chemical product substances) intended for preventlnc. pest and weed. (any substance or mixture destroyinc or control line of any Retardant a chemical substance which increases the plant stability acalnst lie down. Substrate - nutrition settinc in which various orcanisms live. I Chapter The General Conditions Article 1 The Tasks of the Plant Protection The tasKs of the plant protection are: i) to ensure the protection of the plants. especially crops and their yield acainst plant diseases. pests and weeds as well to protect the plants acainst unparasitic plant diseases; 2) to safecuard the plant products acainst mycotoxins and other d a ne e r oue admixtures in quantities which are riskY for human and animal health; 3) not to al low the taken measures of the plant protection unfavourably influence the environment and to accumulate the residues of the u6sd pest icides in the p I ant products. soi I and water over the permitted rates; ArtIcle 2 3 The Sphere of Action of the Law of the Plant Protection 1) All the land areas the landowners possess recardless the land area quantity or kind of usace, are subordinated to the plant protection acainst plant diseases, pests, weeds and unparasitic plant diseases. 2) The I and owner, in hired areas the hirer are for the performance of the plant prot.ection measures, contract of hirine is not envlsaced otherwise. II Chapter The Plant Protection Service responsible if in the Article 3 The Structure of the Plant ProtectiDn Service (1) The Plant Protection in the State is oreani2ed, directed and controlled by the state institution the state Plant Protection Station, which Is the status leeal pe~gon, subordinated to the MInistry of Acriculture. The Statute of the State Plant Protection Station is cofirmed by the Minister of Aariculture. (2) The State Plant Protection Statton is manaced by the D'f r-ec t.o r , who simultaneously is the Main State Inspector of the Plant Protection in LatvIa. He Is appoInted and dismIssed from the positIon by the MinIster of Aericulture. (3) The Director of State Plant Protection Station : i) Is responsIble for the plant protection undertakincs in State and follows that the Plant Protection Service In its activities observes the requirements referrinc to work, envIronmental protection and other spheres stated In the leeal documents; 2) ensures the observation of law and lecal documents of Cat net in the sphere of the plant protection and in the work of Plant Protection Service. Article 4 The Competence of the Ministry of Acriculture in Plant Protection The Ministry of Acrlculture in Plant Protection: 1) prepares the Law and the draft issues of the Cabinet on problems of the plant protection; 2) issues the reculatlons and recommendations on the use of the plant protectIon products and the performance of correspondlna plant protectIon measures; 3) supervises the Plant ProtectIon in Latvia; 4 4) controls the reserves of the pesticides in the State. not to a I low to purchase and accumu I ate the preparat ions in z r o und less quantities. which t.u r-n f nz into toxic unliquides e nd a n z e r- the environment and are risky for human and animal health; on State buedet's resources forms the States pesticides reserve and coordinatine with the National Centre of Environmental Health def i nes the assortment and quant I ty of such preparat Ions wh ich are necessary for control of harmful or~anlsms of unexpected and in particularly daneerous multlplytne cases. 5) Cancels the instructton of the Director of the State Plant Protection Station i£ he violates the Statutes of the State Plant Protection Station and the authority stated In this Law and if the performance of these instructions could do harm to human and animal health. environment and promota the spreadine of the plant pests and diseases as well as the deterioration of the quality of plant products. Article 5 The competence of the State Plant Protection Station (1) The duty of the State Plant Protection Statton is to ascertai n the appearance of the p I ant pests and diseases in the State. In due time to forecast their development and promote the measures of the plant protection and quarantine In such quantities which would restrict the spreadlne of the plant pests. diseases and weeds and decrease their ne£atlve influence. (2) The State Plant Protection Station for this purpose has the riehts 1) to form the Reeister of Plant Protection Products; 2) to confirm The Reeulations of Plant Quarantine; 3) to confirm Protection Products. Environmental Health; The Reeulatlons of trade and use c o o r-d Lrra t Lnz them with the National of Plant Centre of 4) to Issue phytosanltary export certificates for the plants and plant products. 5) to o r a a n I z e the practice for the land users how to perform the plant protection measures. to define the necessary kn ov l ed z e minimum In plant protection and hand out them certificate which ~ives the rleht9 to purchase and use the necessary pesticides a~ainst plant diseases. pests and weeds; 6) to inspect and check the warehouses. in means of transport. in I and areas due to the form of other conditions; plants and plant production production premises. as well manaei n a , ownersh i P. season in as and 7) to take samples of plant products. plant seedllne. soil as wei I as the other samples for analyses without compensation in quantities determined in the The Re£ulations of Plant Quarantine. 5 8) to demand and ~aln the information from the land users (owners) about emere:ence of the plant dIseases and pests. their distribution and the performed plant protection measures; 9) to eive task to the land users (owners) and the processors of plant production to ensure the destruction of noxious or~anisms or exposed to dane:er objects. the desinfection and desinsection of the soi 1. substrates and premIses. the application of appointed pI ant protection products. devices and methods of treatment; 10) to forbId the cultivation of defInite plants. to exploitate the solIs whIch are polluted with noxious ore:anisms temporary or all the time. utilization the infected seed or seedline: as well as transportation and sale of infected plants or plant products. or import and use of nonree:istered plant protection products. 11) If necessary. to state (perform) quarantIne in some farm. pae:asts (small rural d Ls t.r-Lc t.L, district or in all the State. coordinatine it with the correspondine: self-e:overnment or e:overnment (if quarantine is stated in all the State). III Chapter Plant Protection Products. Undertakings and Machinery Article 6 Use of Plant Protection Products (1) In Latvia there are allowed to use only plant protection products which are included in the Ree:ister of Plant Protection Products. The Ree:ulations on Ree:istration of plant protection products are comfirmed by the Minister of Ae:riculture. coordinatin& ~~ wIth the Ministry of the EnvIronmental Protection and Re&ional Development and National Centre of Environmental Health. This order doesn't concern to plant protection products which are intended: 1) for export or transit and are situated in free port or in customs as customs eoods; 2) for use as e:rowth ree:ulator for cut ornamental plants; 3) for appl ication ae:ainst mlcroore.anlsms in closed premises of plants and enterprises, pipelines or for sanitary purposes. (2) The plant protection products which are not ree:istered may be imported only with the permission of the State's Plant Protection Station and after c oor d Lna t I or, with the NatIonal Centre of Environmental Health in the follow!ne: cases: 1) for tests. trials and testine: the dynamics of decomposition of the pesticides; 2) if there is dane:er to protect plants ae:ainst harmful ore:anisms. (3) in the 1-st point second part of this Article (1.2.) the mentioned residue limits in the ae:rlcultural products before realization to consumers - are controlled by the National Centre of Environmental Health. 6 (4) Seeds. live plants and live parts of plants which contain the plant protection products 01" are found there may be imported and realized If these products are 1"eclstered 01" the active substance and Its influence correspond to any forlll of the re£lstered plant protection product. The trade nallle of pesticide should be shown on the overpack af coods. Article 7 Information on Plant Protection Products (1) The State Plant Protection Station ensures all the persons concerned the possibility to £et inforlllation on the Reclster of Plant Protection Products and use of there Included preparations. (2) On the packae;ine; of the plant protection products lIIust be clearly showed the trade nallle of the plant protection product. recistratlon number. name of active substance and Its concentration In the preparation. shelf life. dIrections for use and information on first aid and advice to lIledical doctors. (3) The plant protectIon products may be illlPorted if on the packaeinc are showed data. mentioned in this Article's second part. (4) The information shown in the advertislllent of protection product can't be contradictory ~ith the Recister Plant Protection Products. plant of the Article 8 Control on Trade and Use of Plant ProtectIon P1"oducts (1) The enterprises Ilay 1"ealize the Plant ProtectIon Products after they have cot the Certificate from the State Plant ProtectIon Station. (2) The chemical should be liquidated rellains-. Plant Protection Products which are useless in acco1"dance wIth the 1aw • About Dancerous (3) The trade and use of Plant Protection Products are controlled by the State Plant P1"otectlon Station. Article 9 The Plant ProtectIon Machinery The pi ant. protect.ion machinery are allowed to expl oi t.. if are up to the requirements which are oblleat.e concernine to human's life. health as well as to ensure t.he re£ulat.ions environmental protectIon and exploitation. they the of Article 10 The Obllcat.ions for the Land Users (Owners) in t.he Branch of the Plant Protect.lon The land users (owners) lIlust conscientiously perform the plant protection measures, ensure re~istration of pesticides and inform the State Plant Protection Station about emergence of plant diseases and pests. A~tlcle 11 7 Plant Qua~antlnes "easu~es on Custom-houses (Cont~olposts) The State Plant P~otectlon Station ~o&ethe~ with the conce~ned State Institutions o~canize the cont~ol of Impo~t and export of the plant products as well as the phytosanitary control of such transit coods on custom-houses (control posts). Article 12 Responsibility on Trespass this Law The £uilty person who i£nores the demands of this Law Is called to account accordine to the order of the law. The Law is accepted in Saeima on 6-th October. 1994. The State President G. Ulmanls Rica. 20-th October, 1994 CONFIRMED The Minister of A~riculture of Latvian Republic A. Odris 5-th January, 1995 R E G u L A T I o N s on Reeistration of Plant Protection Products in Republic of Latvia 1. These reeulations are worked out accordine to the Law of Plant Protection In Latvia accepted on October 5, 1994, requirements of .Co u n c i l Directive 91/414/EEC and is o b l Lze d for all I ecal and physical persons who manufacture, import, sal e and use the plant protection products in Republic of Latvia. 2. In Latvia there are allowed to distribute and use only plant protection products and 2rowth re2ulators which are included in the · Re~ister of Plant Protection Products and in accordance with -The Re~ulations of trade and use of Plant Protection Products-. 2.1. The Reeister of Plant Protection Products consists of the list of preparations and the list of active substances (Annex I). 2.2. The Reeulations of Plant Protection Products don't concern to plant protection products which are ' intended a) for export or transit and are situated in free port or in customs as customs coods; b) for use as erowth re2ulatorfor cut ornamental plants; c) for application a2ainst microor2anisms In closed premises of plants and enterprises, pi~elines or for sanitary purposes. 2.3. The plant protection products which are not recistered may be imported only with the permission of the State's Plant Protection Station and after coordination vith the National Centre of Environmental Health in the followinc cases a) for tests, trials and testin2 the dynamics of decomposItion of the pesticides; b) if there is dancer to protect pI ants acai na t, harmfu I or~anisms. 3. Seeds, live plants and live 'parts of plants which contain the p I ant protect I on products or are f qund there may be imported and real12ed if these products are reetstered or the active substance and i t s inf luence o o r r-e s p orrd to any form of reeistered plant protection produ~t. The trade name ~r pr~posed trade name of pestIcide should be shown on the overpack of coods. 9 4. The plant protection product is registered. if its active substance is mentioned in the Register of Plant Protection Products and the following conditions are observed: a) it is ascertained. that with correct use and observation of the normal application conditions. the aftereffects of this usage at the current I evel of science and technics are general I y acceptable and it is approved that : it is sufficiently effective; it has no unacceptable effect on plants or plant products; it doesn't cause unnecessary pain and suffering to the controlled verterbrate animals: it has no harmful effect on human or animal health due to the contamination of drinkin£ water. soil, food, feed or groundwater. has no unacceptable influence on the environment and doesn't impact on non-target species: active substances and or ecotoxicologlcally can be determined by quantity of its toxicologically and co-formulants b) the nature and where appropriate. any significant impurities appropriate methods; c) its residues. resulting from the which are of toxicological or environmental measured and determined: authori2ed uses. and significance. can be d) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product: e) max imum res idue limi t.s (HRLs) In the agricul tural products referred to in the authori2atlon have been provisionally established by the European Community states and notified to the Commission of Registration of Plant Protection Products. Remark : The Commission after that notificatIon in three months' time must decide if in Latvia is acceptable this maximum residue limit (HRLs). provisionally established by the European Communi y States or provisional maximum residue limit must be defined. 5. 5.1. 5.2. 5.3. The application on registration should be submitted by manufacturer: trade firm - authori2ed distributor of the manufacturer: legal or physical person who is Interested in use of the plant protection product in Republic of Latvia. 6. The application on registration of preparation should be submitted to the Ministry of Agriculture State Plant Protection Station. 7. The application on registration of preparation should be submitted in duplicate and should be written in Latvian or after the a~reemant with State Plant Protection Station In Enclish or Russian accordin~ to the form sho~n In Annex 2., with JO additional data of the results of the biolo~ical trial as well as the results of the pesticide residual tests In the yield (if it is necessary in soil too) in conditions of Latvia. which are estimated in the laboratory of National Centre of Environmental Health. Independent laboratory or in the accredited laboratory. 7.1. If preparation is re~lstered with a new active substance not re~lstered In Latvia an application and the data of the biolo~lcal trial as well as the results of the pesticide residual tests in yield (soil) in Latvia durin~ 2 years' period should be submltted. 7.2. If the active substance is re~istered in Latvia there Is necessity of one year's trial of the preparation. 7.3. The active substances and products permitted for application in 1994 In Latvian Republic should be rere~istered and documents should be submitted till the 1st of October. 1995 (data of the b t o l o a t ca l trials as well as the results of the pesticide residual tests In yield (soil) aren't obll~atory). 7.4. After expiration of this date for not rere~istered preparations it is permitted to use only the remnant quantities of them in Latvia. 8. The application an the re~istration of preparation is considered by the Commission of Re~istration of Plant Protection Products. consistin~ of 5 7 people : representatives from State's Plant Protection Station. National Centre of Environmental Health. Ministry of the Environmental Protection and Re~ional Development and representatives of a~ricultural sciences (Annex 3). The Commission is mana~ed by chairman the director of State's Plant Protection Station. For the examination of the application may be invited special ists who have taken part in trials of the preparation in Latvia. if necessary - the experts. 8.1. The sessions of Commission of Re~istration of Plant Protection Products are summoned by chairman. 8.2. State Plant Protection Station's department of Reelstration the Plant Protection Products provides the Commission members with the application documents and with the trial results of preparations and make ready the draft projects. 8.3. The Commission of Re~istration of Plant Protection Products with 2/3 participate members by a majority vote decide to r e z Ls t e r- the preparation or postpone the decision of the issue until the examination of the additional data. 9. The Commission examines the application In 3 months' time if there is no necessity of additional information on the preparation or its active substance. The decision on registration is accepted after the analysis of useful n e s s and the risk of use of preparation. The Commission determines the list of treated crops, the list of harmful o rz e n l e ci s , doses, pre-harvest interval and accepts the prep8rat:.lon's Simul taneously is determined in which I'eg,istration c Las s the plant protection product should be included 1st clagg - products ror applIcation under the ~uidance of the plant protectIon specialist; 2nd class - preparation for landowners and land users who are traIned and have a certificate of knowled~e minimum or plant protection; 3rd class - preparation for application a~aingt pests whithout lImitation. LO. The reElstration of the new preparation is In force for t O years (in exceptional cases the pr-eperation can be reitistered for shorter time. which Is coordinated with the submitter). The registered preparatiQn is written In ·Re~ister 01 the Plant Protection Pr-Qducts In Republic Qf Latvia W (Eor-m is In Annex I) wIth number c o ne t s t Ln e Qr four dIgIts. Simultaneou!:dy Is written the active substance (active substances) with number of three digIts. The State Plant Protection Station issues to the subwitter of application on reelstratlon of the preparatIon ~The RCElstration Certificate of the Plant protection Product W (form is in Annex 4) In Latvian with the reeistr-atlon number Hr. If th~ s ubmJ t.t.e r- 'Jishes there is a possibility to get the duplicate of the Re a Ls t ra t t o n CertifIcate In the language the applicatIon Is submit.ted. The "Re:l:;lster of the Plant Prot.ection Product:3 In Republic of Latvia· Is kept In the State Plant Pr-ot.ectlon Station. The r-e,e:1str-atlon of the product doesn l t ituar-antee the purchase of the pr-epsr-stion but insures the T"ll.l:hts to get the permissiQn from the State Plant Protection Station to import the product In Latvia. After the explr-y or the :.r-eglstr-ation ter-Bl the product could be r e r e z La t e r-e d , If such a wigh 19 expressed by the owner of the RegIstration CertIficate the appl ication of the rere~lgtratiQn should be submitted 6 months befor-e the expir-y of the re,e:lstr-ation ter-m. 11. 'rhe owner- of the Registration Cer-tificate must 1mIned Intel y Inform The State P I ant Pr-o t.eo t f on Station about ··!e changes In the documents or In data which a r e 9ubmitted In the application Qf the reglstr-ation. 12. The State Plant Pr-otectlon Station has the rights durlne the term of action the registratiQn of preparation (10 years from the date oi r-eg,istr-atlon) to claim £r-om the owner of WThe Reitistration Certificate Qf the Plant pr-otectiQn Pr-oduct" additional data or- tr-ial r-esults, if new scientific investigations demand for checkIng-up the r-egistl'atlon. If. such data In terlll, which Is fixed to come to aer-eement with ComIQ19s1on of Regtstr-ation Qf Plant Pr-Qtectlon Pr-oducts. are nQt submitted - the Commission has the rights to annul the Reitistration Certificate. Plant name, 13. I f the owner- or protection Pr-Qduct w he must infQrm the WThe stops State Regi!3tr-atlon Certificate of the his activities or changes the Plant Protection Station about these changes and together with it decide about further- status of the Registration Certificate. 14. Or~anizations concerned and the owner of wThe Reeistration Certificate of the Plant protection Product- have the riehts during the term of action the re~istration of preparation to change the spectre of usin~ the preparation. doses etc. (look 7.2.). The Commission of Re~istration of Plant Protection Products additionally enter the decision about chan~es In the -Register of the Plant ProtectIon Products In Republic of Latviaw • 15. The information shown on the label and advertisment can't be contradictory with the Re~ister of the Plant Protection Products. It doesn't concern to the publications of the scientific papers. 16. If the preparation .is re~istered the receiver of wThe RegIstration Certificate of the Plant protection Product- pays the reeistration fee to the State Plant Protection Station - Ls 500. for rereeistratlon - Ls 200. If the preparation is reeistered for use in elasshouses as well the biological products. entomophages and pheromones the reeistration fee is - Ls 100. The means from the registration fee are used for provision of the registration actions. for publIshing the information about Reeister of Plant Protection Products and the usage of the included preparations. If the procedure of registration is started on behalf of any leeal or physical person. the registratian fee is payed accordine to the lDutual aereement between the submitter of the application and the mover. 17. The submitter of the application before the reeistration of the preparation informs the State Plant Protection Station about the proposed trials of the preparation its general data and active substance by a letter. The State Plant Protection Station comes to an agreement with the submItter of the applIcation concernine the plan of the biologIcal trials and legal or physical person whom to trust the carryin~ out of the field trials of estimation of biological efficacy and dynamics of decomposition of the residuals of the active substance. 18. Pre-reeistration trIals should recommendations of the European Plant (EPPO) and the expierence in Latvia. The trials of the 2-nd year could trials. be arranged following the Protection Organization be used as demonstration 19. the State trials by sends out The submitter of the application on reeistration submits Plant Protection Station the results of pre-registration the i-st December. The State Plant Protection Station the potential submitter of the application a summon to carry out the trials of the 2-nd year by i5-th January; appeal to submit all the data for reeistration of the preparation. 20. The expenditures prepara t i on as we I I as the substance in yield (soil) application. of the pre-recistration trials of the estimation of the residuals of active are paid by the submitter of the 21. If the owner of "The Recistration Certificate of the PI ant protection Product· after some time of the ree,istration of the preparation "'ishes to realize the product with a different percentace or wi th another form of preparation than reeistered before. it is necessity to perform one year's trials and cover the expenditures of the rerecistration (look 16.). The new preparation is to be marked with a new recistration number. 22. The Commission of Recistration of Plant Protection Products can't use the data for the benefit of the second pretender (Is mentioned in Annex 2). before it has not coae to an acreement wi th the first pretender and cot a Letter of access. This condition is valid also a*ter the expiry of the patent rie,hts. 23. State Plant Protection Station and the aeabers of the Commission of the Recistration of Plant Protection Products must ensure the necessary conf idence of the data. It doesn't concern to: the name and composition of the active substance or substancles and the trade name of the plant protection product; preparations containine other substances. which by the Directive 67/S48/EEC. 78/631/EEC and other directives are considered as dancerous; physically - chemical data. which concern to the plant protection product and actve substance; any method to make the active substance or the plant protection product barmless; the summary of the trial results. which clear up the effectivity or harmlessness of the active substance or products to animal and human body. plants and environment; recommended methods and safety precautions for decreaslnc hazard potential of pesticide In storace. transportation and usace; analytical methods for deterllllnincthe nature and quantity of their active substances. toxlcoloe,ically or ecotoxicoiocicaily sicnificant impurities and co-formulants, their residues. resultlnc fro. the authorized use; methods for destruction of the plant protection product and its packacinc; p~ocedu~es fo~ cleaninc to be followed afte~ casual spillaces o~ outflow of pesticides; p~oposed fl~st aid measu~es. medical t~eat.ent In case of polsonlnc the pe~sonnel. The State Plant P~otectlon StatIon Directo~ G. Galvigg Coordinated Coo~dinated The Hinist~y of Welfa~e Di~ecto~ of the Depa~tment of Envi~onmental Health A.. Ju~evlcs 1994. c. - 27. - dec. The Hlnlste~ of the Envl~onmental P~otectlon and Reclonal Development J. lesalnieks 1994. c. -29.- decemb~l M loU Z Z <