Ethiopian Federal Laws

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Title: Biosafety
Proclamation No.: 655/2009
Jurisdiction: Federal
Law Type: Proclamation
Category: Health and Safety
Country: Ethiopia 🇪🇹
Format: PDF (Amharic and English) | Text (English)

A PROCLAMATION ON BIOSAFETY

WHEREAS, the environmental rights provided under Articles 44 and 92 of the Constitution of the Federal Democratic Republic of Ethiopia require that human and animal health, environmental wellbeing and, in general, the socio-economic conditions of the country be protected from risks that may arise from modified organisms;

NOW, THEREFORE, in accordance with Article 55(1) of the Constitution of the Federal Democratic Republic of Ethiopia, it is hereby proclaimed as follows:




1. Short Title

This Proclamation may be cited as the “Biosafety Proclamation No.655./2009”.

2. Definitions

In this Proclamation, unless the context otherwise requires:
  1. "modified organism" means any biological entity which has been artificially synthesized, or in which the genetic material or the expression of any of its traits has been changed by the introduction of any foreign gene or any other chemical whether taken from another organism, from a fossil organism or artificially synthesized;
  2. "transaction" means any making or use of any modified organism in teaching, production, import, export, transit, release, contained production, transport, placing on the market, or use as pharmaceutical, as food, as feed or for processing;
  3. "making" means the development of a modified organism through modern biotechnology;
  4. "contained use" means any operation in which modified organisms are produced, grown, stored, destroyed or used in some other way including for teaching and research isolated by physical and chemical barriers in space not exceeding the requirement stated in the appropriate directive issued by the Authority with a view to effectively preventing their contact with, and their unintended impact on, human, animals and the external environment;
  5. "deliberate release" means any introduction into the environment of a modified organism based on an advance informed agreement and includes, inter alia, any use in commerce, food, aid food, remediation, teaching, research, greenhouses, aqua-culture, animal feed or other inputs for animals, medicines for humans or animals, or disposal;
  6. "advance informed agreement" means a written consent granted by the Authority for the undertaking of a transaction in accordance with this Proclamation;
  7. "placing on the market" means obtaining an advance informed agreement for deliberate release and making available to third parties a modified organism for any use by selling, giving away or in any other way, and includes giving as aid food;
  8. "socio-economic impact" means any direct or indirect adverse effect that results from a transaction on the social or cultural conditions, the livelihood or indigenous knowledge systems or technologies of a local community, including on the economy of the country;
  9. "risk" means direct or indirect, short, medium or long-term danger that may befall human or animal health, biological diversity, the environment, socio-economic or cultural conditions of local communities or the economic condition of the country from any transaction;
  10. "Protocol" means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity ratified by Proclamation No. 362/2003;
  11. "competent national authority" means the institution of a country of export of any modified organism designated by the government of that exporting country to carry out the functions stipulated under Articles 7 to 12 of the Protocol;
  12. "Authority" means the Environmental Protection Authority of the Federal Democratic Republic of Ethiopia established pursuant to Proclamation No. 295/2002;
  13. "competent licensing agency" means any organ of government empowered by law to issue a business license or a work permit;
  14. "inspector" means a person appointed pursuant the directives issued by the Authority to undertake examination and any other control measures to ensure compliance with this Proclamation and with regulations and directives issued hereunder;
  15. "national biosafety clearing-house" means a system of acquisition and management of, and access to, information established by the Authority based on Article 20 of the Protocol in order to facilitate the exchange of scientific, technical, environmental and legal information and experience with modified organisms;
  16. "region" means any regional state referred to in Article 47 of the Constitution of the Federal Democratic Republic of Ethiopia and includes the Addis Ababa and Dire Dawa city administrations;
  17. "applicant” means any person who submits an application to the Authority seeking an advance informed agreement to engage in a transaction;
  18. "authorized person” means any person who has been given an advance informed agreement by the Authority;
  19. "person” means a natural or juridical person;
  20. any expression in the masculine gender includes the feminine.

3. Scope of Application

  1. Without prejudice to the provisions of subarticle (2) and (3) of this Article, this Proclamation shall apply to any transaction.
  2. Any treaty, provided that it has been ratified by Ethiopia, on the regulation of modified organism that is to be used as a pharmaceutical for humans, that is to transit through Ethiopian territory or that has been declared to have no adverse effect shall be applied throughout the territory of Ethiopia.
  3. The Authority shall place information regarding the transactions referred to under sub-article (2) of this Article on the National Biosafety Clearing House established under Article 13 of this Proclamation.

4. Objective of the Proclamation

The objective of this Proclamation is to protect human and animal health, biological diversity and in general, the environment , local communities and the country at large by preventing or at least managing down to levels of insignificance the adverse effects of modified organisms.

5. Advance Informed Agreement

  1. Without prejudice to the provisions of Article 3 of this Proclamation, no person shall engage in any transaction without obtaining an advance informed agreement.
  2. Any person who intends to engage in any transaction shall submit to the Authority an application prepared in accordance with this Proclamation and regulations and directives to be issued pursuant to this Proclamation.
  3. The Authority may, as a condition for giving any advance informed agreement, require the applicant to furnish a guarantee which shall be sufficient to meet his obligations under this Proclamation.

6. Responsibility of Applicant

  1. The applicant shall use a qualified expert to undertake a risk assessment and prepare the report in accordance with regulations and directives issued pursuant to this Proclamation and submit the same to the Authority together with any other documents determined as necessary by the Authority.
  2. Besides a detailed technical analysis, a risk assessment report shall include a brief statement summarizing the report in nontechnical terms.
  3. The cost of carrying out a risk assessment and writing a risk assessment report shall be borne by the applicant.

7. Identification and Labeling

  1. No transaction shall be carried out outside of the contained conditions of a laboratory unless the package of the modified organism has been labeled in both Amharic and English in accordance with the relevant regulations and directives issued pursuant to this Proclamation.
  2. It is prohibited to write “may contain modified organisms” or any equivalent unspecific statement on a label.
  3. It is prohibited to leave out any modified organism that is in the package of a modified organism unwritten on the label.
  4. Any person is entitled to write the words “contains no modified organism” when the product in a package is known to be free from modified organisms.

8. Importation of Modified Organisms

  1. Importation of any modified organism without obtaining an advance informed agreement is prohibited.
  2. An application for an advance informed agreement for the importation of a modified organism shall be accompanied by a statement signed by the head of the competent national authority of the country of export to the effect that the competent national authority takes full responsibility for the completeness and accuracy of the information provided.

9. Making and other forms of Contained Use

  1. Any person who makes a modified organism shall take into account the characteristics of the parental organisms used, the research site and the surrounding environment, and apply scientifically acceptable and environmentally sound practices based on the precautionary principle in order to minimize possible risks to insignificant level.
  2. Any person that uses a modified organism under contained conditions shall ensure that the necessary safety precautions, including measures to limit the detrimental effects of any unintentional release, are taken and shall keep records of all the making or use of the modified organism and of any unforeseen event encountered.
  3. Any contained use shall take place only in a facility registered by the Authority for such use in accordance with regulations and directives issued pursuant to this Proclamation.

10. Transit

  1. A person who wishes to carry out any transit of a modified organism through the territory of Ethiopia shall notify the authority before that transit takes place.
  2. The Authority shall place any modified organism that it deems dangerous to transit through the territory of Ethiopia in the Biosafety Clearing-House of the Protocol.

11. Public Participation

  1. The Authority shall, upon receipt of the risk assessment report, disseminate it to the relevant stakeholders through a public notice and accept comments for a period of not more than one month.
  2. Comments on the granting or refusal of an advance informed agreement for the transaction may be made in writing by any person within the time limit specified by the Authority.

12. National Biosafety Clearing-House

  1. The Authority shall establish a National Biosafety Clearing-House.
  2. The National Biosafety Clearing-House to be established pursuant to sub-article (1) of this Article shall contain information on:
    1. a roster of experts that shall include the names, contact addresses and relevant information on experts in Ethiopia in modified organisms;
    2. a list of modified organisms that have been approved and rejected for import and export;
    3. applications lodged pursuant to the provisions of this Proclamation;
    4. relevant proclamations, directives, guidelines and codes of practice;
    5. any national emergency response plan to manage any accidental release;
    6. information required by the Authority for giving an advance informed agreement;
    7. any relevant bilateral, regional and multilateral agreements and arrangements;
    8. the Authority’s final decisions on the importation and on the deliberate release of modified organisms;
    9. other information that is required to implement this Proclamation.
  3. The public shall have access to any record or document filed in the National Biosafety Clearing-House.
  4. Any information determined as confidential pursuant to Article 13 of this Proclamation shall not be placed on the National Biosafety Clearing-House.

13. Confidential Information

  1. Every applicant shall have a right to notify the Authority specifying the information to be treated as confidential.
  2. Following a written request by the applicant for keeping information confidential, the Authority shall determine the information which is essential for biosafety and for other reasons not to be confidential and inform the same to the applicant. The applicant may then agree with the Authority or withdraw his application.
  3. Notwithstanding the provisions of subarticle (1) and (2) of this Article, in no case may the following information supplied by an applicant be kept confidential:
    1. description of the modified organism, name and address of the applicant, purpose and location of the transaction;
    2. methods and plans for monitoring the modified organism and for emergency response;
    3. the evaluation of possible effects, in particular any pathogenic or ecologically disruptive risks.
  4. If the applicant withdraws the application, the Authority shall respect the confidentiality of the information except for that part referred to in sub-article (3) of this Article.

14. Decision making

  1. The Authority shall make its decision on the application by taking into account the information presented by the applicant, the information found in the Protocol and the National Biosafety Clearing-Houses, expert opinion and stakeholders’ comments, and in consultation with the concerned public agencies.
  2. The Authority may, prior to taking a decision, request for further information as it may deem necessary. Any applicant who fails to supply the required further information shall be deemed to have withdrawn the application.
  3. The Authority shall, within 15 days after it has received the opinion of experts as well as stakeholders’ comments, evaluate the risk assessment report and:
    1. approve the report without conditions and give its advance informed agreement if it is convinced that the transaction will not pose any significant risk;
    2. approve the report and issue an advance informed agreement with conditions that must be fulfilled in order to eliminate or reduce to insignificant level risks if it is convinced that such risks can be effectively contained;
    3. require the applicant to provide more information to enable better informed decision making; or
    4. reject the report and deny an advance informed agreement.
  4. The Authority shall lodge a copy of the decision given in accordance with subarticle (1) of this Article in the National Biosafety Clearing-House within one week of issuing it.

15. Review of Decision

  1. Any advance informed agreement given may be revoked or subjected to additional conditions if the authority obtains new information that shows, or a review of existing information indicates, any significant risk from the modified organism.
  2. Where information becomes available to the applicant after receiving the advance informed agreement on possible significant risk, the applicant shall immediately notify the Authority.
  3. If any condition contained in an advance informed agreement is not strictly complied with, the Authority may take any action that it may consider appropriate for the immediate cessation of the transaction, including the destruction of the modified organism.
  4. Any application to reconsider a refusal of an advance informed agreement for any transaction shall be treated as a new application if it is accompanied by new scientific information. Otherwise a refusal shall be final.

16. Duration of Validity of an Advance Informed Agreement

  1. An advance informed agreement shall expire if the transaction has not been performed within the time frame set out for it during its approval.
  2. Any applicant who wishes to challenge the appropriateness of expiry of an advance informed agreement pursuant to sub-article (1) of this Article may submit a written application to that effect to the authority within fifteen days from the date of expiry.
  3. Within 30 working days from the receipt of an application pursuant to sub-article (2) of this Article, the Authority shall decide whether to extend the validity of the advance informed agreement or to order the revision or the redoing of the risk assessment.

17. Duties of Authorized Persons

  1. Every authorized person shall, within the time specified in the approved risk assessment report, submit to the Authority a written report on the transaction that he has been carrying out.
  2. No authorized person shall transfer any modified organism that has not been put on the market to any other person without obtaining a new advance informed agreement from the Authority.
  3. Any authorized person shall, in accordance with regulations and directives to be issued pursuant to this Proclamation, develop and implement his own risk management strategy to protect human and animal health and the environment from any risk.
  4. Every authorized person shall immediately inform the Authority whenever any modified organism is lost or stolen from him.

18. Duties of Competent Licensing Agencies

  1. Every competent licensing agency is prohibited from giving a license for any transaction uless the applicant has submitted to it an advance informed agreement.
  2. Every competent licensing agency shall suspend or cancel any license it has given following the decision of the Authority to suspend or cancel the advance informed agreement that it has granted.

19. Powers and Duties of Inspectors

  1. Any inspector may, for the purpose of ensuring compliance with provisions of this Proclamation and regulations and directives to be issued pursuant to this Proclamation:
    1. enter any place or facility in which a transaction is taking place;
    2. inspect and order the taking of any corrective measures on the transaction being carried out;
    3. request and obtain information from any person carrying out or in charge of the transaction;
    4. examine and obtain a copy of any record or document related to a transaction; and
    5. take free of charge samples of any material or substance as required and carry out or cause to be carried out tests he considers appropriate.
  2. Every inspector shall exercise in due diligence and impartiality in the discharge of his powers and duties pursuant to this Proclamation and shall show his identity card whenever requested.

20. Inspections at Points of Entry and Exit

  1. Any person in possession of any modified organism shall, on arrival or departure, declare such possession to the customs officer on duty at the point of entry or exit.
  2. Where a customs officer suspects that any person is in possession of a modified organism or any load contains any modified organism, without a written advance informed agreement, he shall impound it and notify the Authority.
  3. The customs officer shall store the suspected modified organism referred to under sub-article (2) of this Article in such a manner that risks to biodiversity, the environment or human health are minimized.
  4. The Authority shall, by examining samples, verify whether the impounded material referred to under sub-article (2) of this Article contains any modified organism or not.
  5. If any organism surrendered to a customs officer is determined by the Authority not to be modified, the impounded amount after reducing the amount used up during analysis shall be returned to the person who had surrendered it.
  6. If the material impounded and stored pursuant to sub-article (2) of this Article is proved to contain any modified organism and if it is not taken out of Ethiopia within 30 days, the Authority shall destroy it by incineration or by any other method it deems appropriate.
  7. Where any imported modified organism remains unclaimed at the port of entry for more than two weeks, the Authority, together with a customs officer or other appropriate government officer, may take any action necessary to send back the modified organism to the country if came from or to dispose of it in an environmentally sound manner
  8. Neither the Authority nor the customs official shall be held liable for any deterioration in storage in the condition of the contents of the material impounded and stored under subarticle (3) of this Article unless manifest failure to take reasonable measure is proved.
  9. All costs of any disposal, safe-keeping or re-export of any load of modified organism that has been impounded under sub-article (2) of this Article shall be borne by the person who had surrendered it.

21. Penalties

  1. Unless the act entails higher penalty under the provisions of the Criminal Code:
    1. any person who engages in any transaction with the intention of causing harm to human health, biological diversity, the environment or property shall be punishable with rigorous imprisonment from 10 to 15 years.
    2. any person who violates any provision of this Proclamation or regulations or directives issued pursuant to this Proclamation shall be punishable with a fine from Birr 4,000 to Birr 7,000 or with imprisonment from one to three years or both.
  2. Where the offense is committed by a juridical person the penalty shall be determined in accordance with the provisions of Article 90 of the Criminal Code of the Federal Democratic Republic of Ethiopia.
  3. In the case of an offense committed by a juridical person, in addition to the penalty imposed to the entity, the officer of the entity who has failed to exercise all due diligence shall be punishable in accordance with sub-article (1) (b) of this Article.

22. Power to Issue Regulation and Directive

  1. The Council of Ministers may issue regulations necessary for the implementation of this Proclamation.
  2. The Authority may issue directives necessary for the implementation of this Proclamation and regulations issued pursuant to sub-article (1) of this Article.

23. Effective Date

This Proclamation shall enter into force up on the date of publication in the Federal Negarit Gazeta

Done at Addis Ababa, this 9th day of September, 2009
GIRMA WOLDEGIORGIS
PRESIDENT OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA



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