PART ONE GENERAL
1. Short Title This Proclamation may be cited as the “Pesticide Registration and Control Proclamation No.674 /2010.”
2. Definitions In this Proclamation, unless the context otherwise requires: 1/ “active ingredient” means the biologically active part of a pesticide present in a formulation; 2/ “adulterated pesticide” means a pesticide that: a) any of its constituent has, in whole or in part, been omitted or abstracted; b) its being damaged or inferior has been concealed in any manner; c) any substance has been substituted wholly or in part of it; d) any substance has been added to it or mixed or packed with it so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; e) any constituent exceeds the amount stated on its label or permitted by this Proclamation; or f) its nature, substance, or quality has been injuriously affected; 3/ “advertising” means the promotion of the sale or use of pesticides by printed or electronic media, signs, displays, gift, demonstration, or word of mouth; 4/ “banned pesticide” means a pesticide for which all registered uses have been prohibited by regulations issued under this Proclamation, or for which all requests for registration or equivalent action for all uses have, for health or environmental reasons, not been granted; 5/ “Basel Convention” means the Basel Convention on the Control of Trans-boundary Movements of Hazardous Wastes and their Disposal signed on March 1989; 6/ “biological control agent” means a natural enemy, antagonist or competitor or other organism used for pest control, and includes biochemical and microbial pest control agents; 7/ “bio-pesticide” means a biological control agent, usually formulated and applied in a manner similar to a chemical pesticide; 8/ “certificate of competence” means a certificate demonstrating that a person has the necessary qualifications to handle the type of pesticide in the manner indicated on the certificate; 9/ “container” means any thing in which or by which pesticides are encased, covered, enclosed, contained or packed, including material in contact with the pesticide; 10/ “disposal” means any operation to recycle, neutralize, destroy or isolate pesticide waste, used containers or contaminated materials; 11/ “distribution” means the process by which pesticides are supplied through trade channels to local or international markets; 12/ “formulation” means the combination of various ingredients designed to render a pesticide product useful and effective for the purpose claimed, or the form of the pesticide as purchased by users; 13/ “hazard” means the inherent property of a substance, agent, or situation having the potential to cause adverse effects or damage to human or animal health, the environment or property; 14/ “label” means a written, printed or graphic matter on, or attached to the immediate container of a pesticide and the outside container or wrapper of the immediate containers; 15/ “manufacture” means to prepare, compound, formulate, mix or make a pesticide for its distribution or use; 16/ “Ministry” or “Minister” means the Ministry or Minister of Agriculture and Rural Development, respectively; 17/ “obsolete pesticide” means a pesticide: a) the use of which has been banned or severely restricted for environmental or health reasons by applicable provisions of the Basel Convention,the Stockholm Convention or the Rotterdam Convention; b) that has deteriorated as a result of improper or prolonged storage and can neither be used in accordance with its label specifications nor easily reformulated for use; or c) that cannot be used for its intended purpose; 18/ “packaging” means the container together with the protective wrapping used to carry pesticide products via wholesale or retail distribution to users; 19/ “person” means a natural or legal person; 20/ “pesticide” means any substance or mixture of substances or a living organism intended for preventing, destroying or controlling: a) any pest, including vectors of human or animal disease; b) unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport or marketing of food, agricultural commodities, wood and wood products or animal feed stuffs; or c) insects or other pests on bodies of animals; and includes substances intended for use as a plant growth regulator, defoliant, desiccant, or agent for thinning fruit or preventing the premature fall of fruit, and substances applied to crops either before or after harvest to protect the commodity from deterioration during storage and transport; 21/ “pesticide dealer” means any person engaged in the formulation, manufacture, packing, re-packing, labeling, import, export, storage, sale, distribution, transport or pesticide application service; 22/ “prior informed consent procedure” means the procedure under the Rotterdam Convention for exchanging and handling information on banned or severely restricted chemicals and severely hazardous pesticide formulations in international trade; 23/ “quality” means the degree of conformity to established national standards issued by the Quality and Standards Authority of Ethiopia, or international standards accepted for use in Ethiopia; 24/ “Rotterdam Convention” means the Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade signed at Rotterdam on September 1998; 25/ “state” means any state referred to in Article 47(1) of the Constitution of the Federal Democratic Republic of Ethiopia, and includes the Addis Ababa and Dire Dawa city administrations; 26/ “appropriate organ” includes the Ministry of Health and the institution responsible for food, medicine and health care administration and control, the Ministry of Trade and Industry, the Ministry of Labour and Social Affairs, the Environmental Protection Authority, as well as organs in charge of the agricultural sector, environmental protection, trade and industry and public health at regional level; 27/ “repackaging” means the authorized transfer of a pesticide from any commercial package into any other, usually smaller, container for subsequent sale; 28/ “restricted use pesticide” means a pesticide determined by the Ministry to be unsafe for use by persons not holding a certificate of competence, and is included on a list prescribed by the Ministry on restricted use pesticides; 29/ “sales outlet” means premises or facilities used for the sale of pesticides; 30/ “sell” means to offer for sale or to have pesticides in possession for sale; 31/ “severely restricted pesticide” means a pesticide for which virtually all registered uses have been prohibited although specific registered uses remain authorized; 32/ “Stockholm Convention” means the Stockholm Convention on Persistent and Organic Pollutants signed on May 2001; 33/ “store” means to store pesticides for sale or for own use other than sell; 34/ “trade name” means the name under which a pesticide is labeled, registered, or promoted by a person granted registration of the pesticide under this Proclamation, and which can be used exclusively by that person to distinguish the product from other pesticides containing the same active ingredient; 35/ any expression in the masculine gender includes the feminine.
PART TWO REGISTRATION OF PESTICIDES
3. Requirement for Registration 1/ No pesticide shall be registered unless the efficacy, safety and quality is tested under field or laboratory conditions and approved by the Ministry. No person may formulate, manufacture, import, pack, re-pack, label, sell, distribute, store or use a pesticide not registered by the Ministry or contrary to the conditions of its registration. 2/ Notwithstanding sub-article (1) of this Article, the Ministry may authorize importation of unregistered pesticide in prescribed quantities for research or experimental purposes only and not for distribution. 3/ Notwithstanding the provisions of sub-article (1) of this Article, the Ministry may allow the importation and use of pesticides which has not been registered due to compelling reasons. 4/ The compelling reasons referred in sub-article (3) of this Article shall be determined in the directive to be issued for the implementation of this Proclamation.
4. Applications for Registration 1/ An application to be submitted to the Ministry for the registration of a pesticide shall be made in the prescribed form and contain the data specified in regulations issued hereunder. 2/ Where the information submitted in accordance with sub-article(1) of this Article is incomplete the Ministry shall notify the applicant in writing of the respects in which the information is insufficient, and the application may be supplemented within eight weeks of receipt of such notification. 3/ If the applicant does not supplement the application within the time specified in sub-article (2) of this Article, the application shall be rejected. 4/ Any applicant who is not residing in Ethiopia shall appoint an agent permanently residing in the country to whom any notice or correspondence may be sent.
5. Decision on Application for Registration 1/ The Ministry shall authorize the registration of a pesticide upon examining the application and ascertaining that: a) the information contained in the application is complete and accurate; b) the pesticide is effective for the purpose for which it is intended; c) the pesticide does not cause human and animal health hazards when handled and applied in accordance with the instructions; d) the effect of the pesticide on the environment and non-targeted species is insignificant in comparison with its benefits and the effects of other substitutable alternatives; e) the residue of the pesticide is not persistent or toxic when metabolized; f) other products which may be equally or more effective but less hazardous are not available; g) the proposed label of the pesticide is appropriate; h) the pesticide is suitable for local conditions; i) the benefits outweigh the risks of use under local socio-economic conditions; j) the pesticide is not banned or severely restricted by an international convention or in another country with an equivalent registration scheme as determined by the Ministry upon the advice of the Pesticide Advisory Board; and k) the applicant has effected payment of the fee as prescribed by the regulation to be issued hereunder. 2/ Where the Ministry decides to register a pesticide, it may subject the registration to any conditions it considers necessary, including: a) limitation or prohibition of the use of the pesticide in a specified area; b) limitation of the use of the pesticide to specified times of the day or of the year; c) requirement to beekeepers of neighbouring areas before application of the pesticide; d) prohibition of application of the pesticide when certain plants are in bloom; e) limitations on sale of the pesticide to persons holding a certificate of competence; f) limitations on use for certain purposes. 3/ The Ministry shall issue a registration certificate to the applicant, attaching a copy of the approved label. The conditions of registration prescribed pursuant to sub-article (2) of this Article shall also be stated in the certificate. 4/ Where the Ministry refuses registration of a pesticide, it shall communicate same, in writing, to the applicant stating the reasons for the refusal. 5/ The refusal of registration under sub-article (4) of this Article shall not prevent the same or a different applicant from making a later application for registration of that pesticide.
6. Validity of Registration The registration of a pesticide shall be valid for five years from the date of issuance of certificate of registration.
7. Renewal of Registration 1/ The registration of a pesticide may be renewed for a similar period upon the expiry of its validity. 2/ An application to be submitted to the Ministry for the renewal of registration of a pesticide shall be made in the prescribed form and contain the data specified in the regulation to be issued for the implementation of this Proclamation and be submitted before 90 days prior to the expiry of the registration. 3/ The Ministry shall renew the registration upon examining the application submitted under sub-article (2) of this Article and ascertaining that the criteria served as a basis for allowing the registration are still maintained.
8. Amendment of Registration 1/ Where changes are proposed to the label or container of a registered pesticide, such change shall be made noticeable in writing to the Ministry with a copy of the proposed label and where required a photograph of the proposed container. 2/ Where the proposed new label or container of the registered pesticide is not in violation of any of the provisions of this Proclamation or other applicable legislations, the Ministry shall amend the registration and issue a new certificate of registration to the applicant.
9. Re-registration If the original applicant of a registered pesticide wishes to change the trade name, formulation, active ingredient concentration or use of the pesticide or is replaced by another person, then an application for registration shall be submitted to the Ministry in order to import, formulate, manufacture, pack, repack, distribute, sell or label that pesticide.
10. Temporary Registration 1/ Where it is ascertained that the pesticide is new manufactured or it is necessary for protecting pests in relation to agriculture or health sector, the Ministry may, up on such preconditions as it may specify and up on payment of the prescribed fee as well as the applicant’s agreement to provide during the effective period of the registration additional scientific and technical information relating to the use and safety of the pesticide, allow temporary registration for a period not exceeding one year where: a) the applicant agrees to provide during that period, additional scientific or technical information in relation to the use and safety for which the pesticide is to be sold or distributed; b) the pesticide is to be sold or distributed only for the emergency control of pest outbreaks that are seriously detrimental to public health, domestic animals, crops or natural resources in the country. 2/ Where the applicant so requests and the Ministry finds it justifiable, it may, upon such terms and conditions it may specify, grant an extension of the temporary registration for an additional period of not more than one year. 3/ The pre-conditions provided under sub-article (1) and (2) of this Article shall be determined by the directive to be issued for the implementation of this Proclamation.
11. Suspension and Cancellation of Registration 1/ The Ministry may cancel the registration of a pesticide if it determines that: a) the registration was secured in violation of any of the provisions of this Proclamation; b) continued registration is undesirable on the grounds of harm to plant, human or animal health or the environment; c) the pesticide is proven by research to be no longer effective for its intended use; d) the pesticide is withdrawn from the market and has been so notified by the manufacturer; e) any condition attached to the registration has been violated; or f) subsequent to the registration the Ministry has become aware of new facts or an unforeseen change in circumstances which require cancellation. 2/ Before effecting any cancellation under sub-article (1) of this Article, the Ministry shall give the registrant 60 days to submit a written justification as to why the registration should not be cancelled. 3/ The Ministry shall notify the registrant of its decision within 60 days of receipt of written justification under sub-article (2) of this Article. 4/ Pending the submission of written justification under sub-article (2) of this Article and the decision of the Ministry under sub-article (3) of this Article, the registration shall be suspended. 5/ Where registration of a pesticide is cancelled under this Article, the registrant shall return the certificate of registration to the Ministry.
12. Recalls 1/ Where the registration of a pesticide is cancelled, the Ministry may order a recall of the pesticide where necessary to protect human, animal or plant health or the environment. 2/ Any pesticide dealer in possession of a recalled pesticide shall report to the Ministry within 30 days from the date of the recall order.
13. Re-evaluation of Registration The Ministry, acting on its own initiative or upon recommendation of the Pesticide Advisory Board, may undertake a re-evaluation of a registered pesticide: 1/ if it considers that, in the time since the pesticide was registered, there has been a change in the information required to evaluate the pesticide or in the procedures needed to properly evaluate the human, animal or plant health hazards, environmental hazards, efficacy or quality of the pesticide or of pesticides of the same class or kind; 2/ if it has reasonable grounds to believe that the human, animal or plant health hazards or environmental hazards linked to the pesticide are now unacceptable upon consideration of the factors listed in sub-article (1) of Article 5 of this Proclamation and any other relevant factors, including those relating to aggregate exposure to pesticides and cumulative effects of different pesticides; or 3/ in light of recommendations arising from international fora or international organizations.
14. Pesticide Register 1/ The Ministry shall maintain a Pesticide Register which shall contain a list and information on all registered pesticides in the country. 2/ The Ministry shall maintain a separate central database or archive containing the inventory of all pesticides in order to track the movement and use of pesticides according to each stage of the pesticide life cycle within the country and containing other relevant information. 3/ The database or archive shall include: a) types and quantity of pesticides imported, locally manufactured and used in the country, b) pesticides in government and private storage facilities, c) pesticides that have become obsolete while in storage facilities or sales outlets, d) information gathered by pesticide inspectors and records kept in accordance with Article 32 of this Proclamation, e) information received from the monitoring and enforcement activities carried out by the appropriate organs, f) results of any quality tests of pesticide formulations on the market, g) pesticides that Ethiopia has, under the Prior Informed Consent Procedure of the Rotterdam Convention, consented to or refused import, h) information on licenses and certificates of competence, and i) such other issues as may be deemed useful for purposes of adequate pesticide management in the country. 4/ The information maintained pursuant to this Article shall, except proprietary and confidential information, be accessible to the public; provided however, that any person who wants to obtain a copy of such information shall be required to pay the applicable fees.
PART THREE CERTIFICATE OF COMPETENCE AND LICENSING
15. Certificate of Competence 1/ Any person who intends to manufacture, formulate, pack, repack, label, import, export, store, sell, distribute, transport, or offer pesticide application services shall obtain a certificate of competence, which shall be a precondition for the issuance of a business licence. 2/ Certificates of competence relating to the following shall be issued by the Ministry: a) the manufacturing and formulation of pesticides; b) import and export of pesticides; and c) pesticide application service involving fumigation. 3/ Certificates of competence relating to pesticide business other than those specified under sub-article (2) of this Article shall be issued by regional state organs in charge of the agricultural sector. 4/ The conditions of issuance, renewal, suspension and revocation of certificates of competence shall be prescribed by the regulation to be issued for the implementation of this Proclamation.
16. Business Licenses 1/ Business licenses required by holders of certificates of competence issued under Article 15(2) of this Proclamation shall be issued by the Ministry of Trade and Industry in accordance with the relevant laws. 2/ Business licenses required by holders of certificates of competence issued under Article 15(3) of this Proclamation shall be issued by regional state organs in charge of trade and industry.
17. Import Permit 1/ No person shall make any import order of any pesticide without obtaining an import permit issued by the Ministry. 2/ The Ministry may refuse to issue an import permit and shall inform the applicant in writing of the refusal, stating the reasons thereof where: a) the information in an application for an import permit is false or is incomplete; b) the application relates to any pesticide which is not registered; c) the pesticide creates potential hazards or harmful residues; or d) importation of the pesticide violates the provisions of this Proclamation. 3/ No pesticides consignment shall be: a) imported if it has been manufactured before six months from its date of entry into the country; b) imported without a batch certificate of analysis and a material safety data sheet: or c) released from customs without inspection and issuance of import certificate by the Ministry. 4/ Notwithstanding sub-article (3)(a) of this Article, the Ministry may grant permit for pesticide import intended for research or trial or upon being convinced that the stock can be fully utilized before the expiry date of the pesticide. 5/ No person may export pesticide abroad without obtaining an export permit from the Ministry.
PART FOUR PACKAGING, LABELLING, ADVERTISING, TRANSPORT AND DISPOSAL OF PESTICIDES
18. Packaging and Labeling 1/ No person shall pack or repack any pesticide unless it is in a container which: a) is safe for storage, handling and use; and b) prominently displays a legible label in Amharic and in English, which has been approved and cannot easily be detached. 2/ Where a pesticide is contained in more than one container, the requirements of sub-article (1)(b) of this Article shall apply: a) to the container which represents the smallest unit of the pesticide which can be sold separately; and b) to a container containing more than one retail unit.
19. Advertising 1/ No person shall advertise any unregistered pesticide 2/ Any pesticide, even if registered, cannot be advertised if the advertisement: a) is misleading or is intended to deceive; b) employs any false or misleading comparisons with any other pesticide; c) contains statements such as “safe”, “non-poisonous”, “harmless” or “non-toxic”; d) fails to remind purchasers and users to read the label; or e) is contrary to the conditions of registration of the pesticide.
20. Transport 1/ Excluding pesticides the use of which has been severely restricted and with the exception of pesticides in small quantities for personal use, no person may transport any pesticide: a) in passengers compartment of a means of transport; or b) in the same compartment of a means of transport with animals or with food, feedstuffs, drugs, toys, clothing, cosmetics, household furnishings or other items that could become a hazard if contaminated. 2/ Any person who transports a container that has previously contained a pesticide shall ensure that the container is physically separated from and does not come into contact with any food, feedstuffs or animals. 3/ Where a means of transport for transporting pesticides has become contaminated as a result of spillages or leaks, the owner of the means of transport shall report to the Ministry in order to have the means of transport decontaminated and cleaned by qualified personnel designated by the Ministry or regional organs in charge of the agricultural sector. 4/ Transport of pesticides shall comply with directives as may be prescribed by the Ministry in consultation with the appropriate organs.
21. Disposal 1/ No person shall dispose of any pesticide or pesticide waste in a manner that may harm human or animal health or the environment. 2/ Any person who imports pesticides or sells pesticides shall be responsible for the disposal of any obsolete pesticide in his custody at his own expenses. 3/ The Ministry shall issue directives on pesticide disposal in consultation with the appropriate organs and shall monitor and control its implementation.
PART FIVE SAFETY MEASURES
22. Occupational Safety 1/ No person shall use or require an employee to use or recommend that another person use a pesticide in any manner other than that prescribed by this Proclamation or contrary to any condition attached to the registration of the pesticide. 2/ Any employer who requires or permits an employee to use or handle a pesticide shall provide facilities and protective clothing required for safe handling of the pesticide and require the employee to use same. 3/ Any employer who requires or permits an employee to work with pesticides shall provide the employee with: a) such instructions as are necessary to enable him to achieve the required standard of competence; b) such periodic medical check-ups as may be prescribed by the Ministry or the Ministry of Health; and c) such expenses of medical and compensation for damages sustained by the worker due to the absence of sufficient direction and appropriate protective equipments on the part of the employer.
23. Reporting of Accidents 1/ Any person who becomes aware of an accident occurring in the vicinity where pesticides are transported, stored, sold or used shall, without delay, report to the Ministry or the appropriate regional state organ. 2/ Any physician or other medical personnel who learn of a person being poisoned by a pesticide shall report to the Ministry without delay. 3/ The Ministry and the Ministry of Health as well as the appropriate regional state organs shall exchange information regarding any accidents reported under sub-article (1) or (2) of this Article.
PART SIX ANALYSIS
24. Designation of Official Laboratory and Analyst 1/ The Ministry may designate any public or private laboratory fulfilling the necessary requirements as an official laboratory for the purpose of conducting tests under this Proclamation. 2/ The Ministry may designate any analyst fulfilling the necessary requirements as an official analyst for the purpose of carrying out analyses under this Proclamation.
25. Certificate of Analysis An official analyst shall, after conducting a pesticide analysis, issue a certificate of analysis stating the method used and other information that may be prescribed by directives of the Ministry.
26. Residue Analyses and Pesticide Treated Net 1/ Pesticide residue analyses for primary agricultural products shall be carried out by the Ministry. 2/ The Ministry shall collaborate with relevant authorities in establishing the maximum residue limits for agricultural products. 3/ Pesticide residue analysis and monitoring on processed agricultural products and human beings shall be conducted by the concerned appropriate organs. 4/ Effectiveness test and supervision of pesticide treated net shall be conducted by the Ministry of Health.
PART SEVEN PESTICIDE ADVISORY BOARD AND INSPECTORS
27. Pesticide Advisory Board 1/ A Pesticide Advisory Board (hereinafter the “Board”) is hereby established. 2/ The Board shall have the following members: a) an officer designated by the Minister ……………………… Chairperson b) an officer in charge of registration of Pesticides…Member and Secretary c) representative of the Ministry of Health……………………Member d) representative of the Environmental Protection Authority… “ e) representative of the Quality and Standards Authority …………… “ f) representative of the Ethiopian Institute for Agricultural Research.. “ g) representative of the Institute of Biodiversity……………………. “ h) representative of the Ministry of Labour and Social Affairs……….. “ j) representative of the Authority of Revenue and Customs……….. “
28. Functions of the Board 1/ The Board shall: a) advise the Ministry in formulating national policies, regulations and guidelines in relation to safe use and management of pesticides and on fees to be collected for the services provided; b) advise the Ministry on the implementation of international conventions relating to pesticide, and to collaborate closely with the national focal point in this regard; c) advise the Ministry concerning the criteria and conditions for the grant, renewal, suspension, amendment to, or revocation of , any registration or license granted pursuant to this Proclamation; d) advise the Ministry on the formulation of rules regarding: (1) the disposal of obsolete pesticides; (2) the use, packaging, labeling, transport, storage, distribution, and disposal of empty pesticide containers; (3) contaminated soils and contaminated equipment; and (4) buried pesticides. e) formulate criteria and rules to be approved by the Ministry regarding which information submitted with applications under Article 4 of this Proclamation shall be considered proprietary and confidential, how records are to be stored and the procedures for accessing them; f) identify capacity building and extension needs; g) carry out needs assessment and ensure that procurement of pesticides is carried out in accordance with this Proclamation; h) carry out or authorize periodic review of pesticides in use; i) review and propose amendments to the list of pesticides classified as banned, severely restricted and restricted use, and the requirements for handling severely restricted and restricted use pesticides; j) advise the Ministry on which countries can be considered sufficiently similar in agriculture and climate to Ethiopia for the purposes of efficacy testing with respect to pesticide registration. 2/ The Board may: a) establish sub-committees comprising members or non members of the Board or both, to advise it on any matter connected to the exercise of its functions; and b) in particular, establish technical committees comprising professionals from the appropriate institutions to advise it on the impact of pesticide use on human health and the environment.
29. Operation of the Board 1/ Any member of the Board who has any personal or financial link to an applicant for registration, or to any other matter which is the subject of deliberations of the Board, shall disclose the link in writing to the Board, which shall determine the appropriate action, including requiring that member’s withdrawal from participation in any deliberations of the Board in relation to the application or the matter in question. 2/ The Board shall meet at least four times per year. 3/ The Board shall keep full and accurate records of its meetings. 4/ The Board shall establish its own rules of procedure.
30. Pesticide Inspectors 1/ An inspector assigned by the Ministry or a regional state organ in charge of the agricultural sector shall have the power, at working hours, without a warrant and upon presentation of his identity card, to: a) carry out periodic inspections of establishments which import, export, manufacture, pack, repack, label, store, sell, distribute, advertise or use pesticides to determine whether the provisions of this Proclamation and the regulations and directives issued pursuant to this Proclamation are being complied with; b) carry out post-registration surveillance to ensure that conditions of registration are complied with; c) require the production of and inspect certificates, permits, licenses, trade licenses, records or other documents relevant for compliance with this Proclamation; d) take samples of any product relevant for compliance with this Proclamation, and submit such samples for analysis; e) seize, against a receipt issued in the prescribed form, any equipment, pesticide, document, record or other things related to pesticides and which the inspector believes has been used in, or which appears to afford evidence of, a contravention of this Proclamation; f) close a pesticide storage facility or sales outlet if it is confirmed that any pesticide stored therein or the manner of its storage is not in compliance with any of the provisions of this Proclamation; g) inspect and monitor biopesticide facilities as well as the application, use, and impact on target and non-target organisms; h) request the assistance of customs or police officers where necessary for the exercise of any duties under this Proclamation; and i) carry out other inspection, monitoring and surveillance activities as may be prescribed by regulations and directives issued pursuant to this Proclamation.. 2/ Any inspector shall be responsible to report to the appropriate body evidences gathered in the course of carrying out inspections enabling to prosecute persons violating the provisions of this Proclamation; such bodies to whom the report is submitted shall have the responsibility to cooperate for the implementation of the law. 3/ Any item seized pursuant to sub-article (1)(e) of this Article shall promptly be returned to its owner once the necessary inquiry or prosecution has been completed, except for illegal pesticides, which if so found by the court shall be confiscated or disposed of in accordance with this Proclamation. 4/ No person assigned as inspector shall, while being so assigned, engage in any business connected with the import, manufacture, sale or distribution of pesticides.
PART EIGHT MISCELLANEOUS PROVISIONS
31. Prohibitions 1/ No person shall import, store, transport or offer for sale any pesticide unless it is packed and labeled in accordance with this Proclamation. 2/ No person shall sell or store a pesticide by adulterating or which he has reasonable grounds to believe may be adulterated. 3/ No person shall formulate, manufacture, import, export, pack, re-pack, label, sell, distribute, store, or use a banned pesticide under any circumstances. 4/ No person shall formulate, manufacture, import, export, pack, re-pack, label, sell, distribute, store, or use a severely restricted pesticide without written authorization from the Ministry.
32. Record Keeping 1/ Any pesticide dealer shall keep records of all quantities of pesticides imported, exported, manufactured, packed, repacked, stored, labeled, transported, distributed or sold and of any other information that may be prescribed by directives of the Ministry, and submit the same to the Ministry or the concerned appropriate organ when so requested. 2/ The Ministry may, by notice in writing, require any pesticide dealer to compile information, conduct tests or monitor experience with a pesticide for the purpose of obtaining additional information with respect to its quality and its impact on the environment or on human, animal or plant health and to convey the information within a specified period. 3/ Information exchange shall take place between the Ministry and the concerned appropriate organs through periodic reports.
33. Penalties 1/ Any person who: a) knowingly sells an unregistered pesticide or a pesticide whose registration has been suspended or cancelled; b) knowingly sells obsolete pesticides; c) knowingly sells pesticide in containers which do not comply with prescribed standards; d) intentionally provides false information on any application, certificate, or other document refered under this Proclamation; e) deceives or misleads an inspector, or tampers with a pesticide or its container such that a sample taken or submitted for analysis incorrectly represents the pesticide; f) intentionally adulterates a pesticide or sells or stores an adulterated pesticide; g) disposes of any pesticide, pesticide waste, or pesticide container in a manner that may harm human or animal health or the environment or in any manner other than that prescribed in this Proclamation; h) imports a pesticide without being in possession of a valid import permit issued by the Ministry pursuant to this Proclamation; i) engages in any of the pesticide business activities listed in Article 15 of this Proclamation without having a certificate of competence; j) stores, uses, or transports a pesticide except as prescribed in this Proclamation; k) intentionally detaches, alters, defaces, or destroys any label on the container of a pesticide; l) knowingly conceals information which subsequently leads to environmental or other damage; m) advertises a pesticide in violation of sub-article (1) or sub-article (2) (a), (b),(c) or (e) of Article 19 of this Proclamation; shall, unless a higher penalty is provided for in the Criminal Code, be punishable with rigorous imprisonment from five to ten years and fine from Birr 25,000 to Birr 50,000. 2/ Any person who: a) fails to furnish information when requested by a pesticide inspector in the exercise of his official duties; b) intentionally opens a store or a container of pesticide sealed by an inspector; c) fails to comply with an order to provide information pursuant to Article 32 of this Proclamation; d) advertises a pesticide in violation of sub-article (2)(d) of Article 19 of this Proclamation; e) requires or permits an employee to apply a pesticide without providing safety equipment as prescribed in this Proclamation; shall, unless a higher penalty is provided for in the Criminal Code, be punishable with imprisonment up to five years and fine from Birr 10,000 to Birr 30,000. 3/ Any person who knowingly releases information deemed proprietary or confidential under this Proclamation is punishable with imprisonment from one to three years and fine from Birr 20,000 to Birr 25,000. 4/ A court convicting a person of an offence may, in addition to the penalty provided for under sub-article (1), (2), or (3) of this Article, order: a) forfeiture or destruction of any thing used in the perpetration of the offence or forfeiture of the proceeds of sale thereof; and b) payment of compensation to any person who has suffered loss as a result of the offence, taking into account factors such as: (1) extent of loss or injury to the person; (2) the seriousness of the offence and the frequency of its occurrence; and (3) pecuniary gains on the part of the offender. 5/ Where a person is convicted pursuanto this Article, the appropriate organ shall revoke his licence or permit related to pesticide
34. Power to Issue Regulation and Directive 1/ The Council of Ministers may issue regulations necessary for the implementation of this Proclamation. 2/ The Ministry may issue directives necessary for the implementation of this Proclamation and regulations issued under sub-article (1) of this Article.
35. Transitory Provisions 1/ Pesticides registered pursuant to the Pesticide Registration and Control Special Decree No. 20/1990 and the Drug Administration and Control Proclamation No. 176/1999 before the coming into force of this Proclamation shall be deemed to have been registered as per this Proclamation and be subject to the provisions of this Proclamation and to regulations and directives issued hereunder. 2/ Pesticides under registration process in accordance with the Drug Administration and Control Proclamation No. 176/1999 shall be transferred to the Ministry following the effective date of this Proclamation.
36. Repealed Laws 1/ The Pesticide Registration and Control Special Decree No. 20/1990 is hereby repealed. 2/ No law, regulations, directives or practice shall, in so far as it is inconsistent with this Proclamation, be applicable with respect to matters provided for in this Proclamation.
37. Effective Date This Proclamation shall enter into force up on the date of publication in the Federal Negarit Gazeta. Done at Addis Ababa, this 25th day of August , 2010 GIRMA WOLDEGIORGIS PRESIDENT OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA
