- THE ENVIRONMENTAL MANAGEMENT AND COORDINATION (CONSERVATION OF BIOLOGICAL DIVERSITY AND RESOURCES, ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING) REGULATIONS, 2006
- ARRANGEMENT OF REGULATIONS
- PART I - PRELIMINARY
- PART II – CONSERVATION OF BIOLOGICAL DIVERSITY
- PART III – ACCESS TO GENETIC RESOURCES
- Access permit
- Notification of application
- Determination of application
- Form of access permit
- Communication of decision
- Validity and renewal of access permit
- Terms, conditions of an access permit,etc.
- Suspension, cancellation, etc, of access permit
- Register of access permits
- Material TransferAgreement
- PART IV – BENEFIT SHARING
- PART V - MISCELLANEOUS
- FIRST SCHEDULE-Form of Application for an Access Permit
- SECOND SCHEDULE-Fees
- THIRD SCHEDULE-Form of Access Permit
LEGAL NOTICE NO. 160 THE ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION ACT THE ENVIRONMENTAL MANAGEMENT AND COORDINATION (CONSERVATION OF BIOLOGICAL DIVERSITY ARRANGEMENT OF REGULATIONS
1— Citation. 2 —Interpretation. 3— Application.
4— Environmental Impact Assessment Licence. 9— Access permit. 10— Notification of application. 11— Determination of application. 12— Form of access permit.
13— Communication of decision. 19— Application of Part. 20— Benefits sharing.
21— Confidentiality. 22 – Transition. 23— Offences. 24— Penalties.
First Schedule – Form of Application of an Access Permit Second Schedule – Fees Third Schedule – Form of Access Permit
IN EXERCISE of the powers conferred by section 147 of the Environmental Management and Co-ordination Act, 1999, the Minister for Environment and Natural Resources, upon recommendation of the Authority, and upon consultation with the relevant lead agencies, makes the following Regulations
THE ENVIRONMENTAL MANAGEMENT AND COORDINATION (CONSERVATION OF BIOLOGICAL Citation. 1. These Regulations may be cited as the Environmental Management and Co-ordination (Conservation of Biological Diversity and Resources, Access to Genetic Resources and Benefit Sharing) Regulations, 2006.
Interpretation. 2. In these Regulations, unless the context otherwise requires -
“access” means obtaining, possessing and using genetic resources conserved, whether derived products and, where applicable, intangible components, for purposes of research, bioprospecting, conservation, industrial application or commercial use;
“access permit” means a permit that allows a person to access genetic resources issued under regulation 4;
“benefit sharing” means the sharing of benefits that accrue from the utilization of genetic resources;
“endangered species” means any species which is in danger of extinction throughout all or a significant portion of its range (due to man-made or natural changes in the environment);
“genetic material” means any genetic material of plant, animal, microbial or other origin containing functional units of heredity;
“habitat” means the place or type of site where an organism or population naturally occurs and includes areas colonized by introduced organisms;
“holotype” means the single specimen chosen for designation of a new species;
“intangible components” means any information held by persons that is associated with or regarding genetic resources within the jurisdiction of Kenya;
“inventory” means a detailed list, report or record of resources, or the process of making such a list, report or record;
“Material Transfer Agreement” means an agreement negotiated between the holder of an access permit and a relevant lead agency or community on access to genetic resources and benefit sharing;
“natural environment system” means relatively intact ecosystems of unique value, such as perennial and seasonal wetlands, highly diverse aquatic ecosystems, or ecosystems promoting a high concentration of rare and unusual species;
“Prior Informed Consent” means an international operation procedure for exchanging, receiving and handling notification and information by a competent authority; and
“threatened species” means any species of plant or animal
which is likely to become an endangered species within the foreseeable future throughout all or significant portion of its range.
Application. 3. These Regulations shall not apply to Cap. 326 Plant Varieties Act;
(c) human genetic resources; and
(d) approved research activities intended for educational purposes within recognized Kenyan academic and research institutions, which are governed by relevant intellectual property laws.
Environmental 4. (1) A person shall not engage in any activity that may
Impact Assessment Licence.
(a) have an adverse impact on any ecosystem; without an Environmental Impact Assessment Licence issued by the Authority under the Act.
Conservation of threatened species.
Inventory of biological diversity.
Monitoring of status.
(2) In this regulation, “exotic species” means any species of plant or animal or microorganism (life form) whose natural range does not, or did not in the past, exist in a specific part of, or the whole of, Kenya and which out-competes all other life forms.
5. (1) The Authority shall, in consultation with the relevant lead agencies, impose bans, restrictions or similar measures on the access and use of any threatened species in order to ensure its regeneration and maximum sustainable yield.
(2) Without prejudice to the generality of the foregoing, the Authority shall, in consultation with the relevant lead agencies 6. (1) Within twenty-four months from commencement of these Regulations, the Authority shall, in consultation with the relevant lead agencies, identify and prepare an inventory of biological diversity of Kenya. 7. The Authority shall, in consultation with the relevant lead agencies, monitor the status and the components of biological diversity in Kenya and take necessary measures to prevent and control their depletion.
Protection of environmentally significant areas.
Access permit.
Notification of application.
Determination of application.
8. This Part shall apply to any area of land, sea, lake or river which the Minister has, by notice in the Gazette, declared to be a protected natural environment system for purposes of promoting and preserving biological diversity in accordance with section 54 of the Act.
9. (1) Any person who intends to access genetic resources in Kenya shall apply to the Authority for an access permit in the form set out in the First Schedule, and such application shall be accompanied by the fees prescribed in the Second Schedule to these Regulations.
(2) The application shall be accompanied by evidence of Prior Informed Consent from interested persons and relevant lead agencies, and a research clearance certificate from the National Council for Science and Technology.
10. The Authority shall, upon receipt of the application, give notice thereof by publication in the Gazette and at least one newspaper with nationwide circulation, or in such other manner as the Authority may consider appropriate, specifying 11. (1) The Authority shall, on receipt of representations or objections to the proposed access permit from the public, review the application and if satisfied that the activity to be carried out shall facilitate the sustainable management and utilization of genetic resources for the benefit of the people of Kenya, issue an
Form of access permit.
Communication of decision.
Validity and renewal of access permit.
Terms, conditions of an access permit, etc.
access permit to the applicant. (2) Upon expiry, an access permit may be renewed for a further period of one year upon payment of the fee prescribed in the Second Schedule and upon such terms and conditions as the Authority may deem necessary to impose.
15. (1) An access permit shall contain such terms and conditions as the Authority may deem necessary to impose.
Suspension, cancellation, etc, of access permit.
Register of access permits.
Material Transfer Agreement.
Application of Part.
Benefits sharing.
16. (1) The Authority may suspend, cancel or revoke any access permit issued under these Regulations where the holder thereof is in contravention of any of the conditions imposed on the access permit or those implied under these Regulations, or of the agreements concluded pursuant to its grant. 10
of the activities under the permit.
(2) The facilitation by the holder of an access permit shall include enjoyment of both monetary and non-monetary benefits arising from the right of access granted and the use of genetic resources. 11
programmes, particularly biotechnological research activities;
(c) participation in product development; (l) joint ownership of relevant intellectual
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property rights.
Confidentiality. 21. (1) On the request of an applicant of an access permit, the Authority may hold some information relating to access to genetic resources the subject of the application as confidential.
(2) Where an access permit is granted, information held as confidential under paragraph (1), with respect to the relevant applicant, shall not be accessible to a person inspecting the register of access permits in accordance with regulation 17.
Transition. 22. A person carrying out any activities involving access to genetic resources immediately before the coming into force of these Regulations shall, within six months from the coming into force thereof, take all necessary measures to ensure full compliance with these Regulations.
Offences. 23. A contravention or failure to comply with any of the matters provided in these Regulations shall constitute an offence.
Penalties. 24. Any person convicted of an offence under these Regulations shall be liable to imprisonment for a term not exceeding eighteen months, or to a fine not exceeding three hundred and fifty thousand shillings, or both.
FIRST SCHEDULE (r. 9)
Form of Application for an Access Permit
Applicants applying as individuals should fill Part I Applicants applying as corporates (organizations) should fill Part II All applicants must fill Part III All applicants must submit ten (10) hard copies and one (1) soft copy of this application to the Authority
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………………………………………………………………………………………
(g) Name of the contact person in regard to this application and the position held in the organization ……………………………………………………………………………………
(No. 8 of 1999)
AND RESOURCES, ACCESS TO GENETIC RESOURCES AND
BENEFIT SHARING) REGULATIONS, 2006
PART I -PRELIMINARY
PART II – CONSERVATION OF BIOLOGICAL DIVERSITY
5— Conservation of threatened species.
6— Inventory of biological diversity.
7— Monitoring of status.
8— Protection of environmentally significant areas.
PART III – ACCESS TO GENETIC RESOURCES
14— Validity and renewal of access permit.
15— Terms, conditions of an access permit, etc.
16— Suspension, cancellation, etc of access permit.
17— Register of access permits.
18— Material Transfer Agreement.
PART IV – BENEFIT SHARING
PART V – MISCELLANEOUS
LEGAL NOTICE NO 160
THE ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION ACT (No. 8 of 1999)
DIVERSITY AND RESOURCES, ACCESS TO GENETIC
RESOURCES AND BENEFIT SHARING)
REGULATIONS, 2006
PART I -PRELIMINARY
PART II – CONSERVATION OF BIOLOGICAL DIVERSITY
PART III – ACCESS TO GENETIC RESOURCES
PART IV – BENEFIT SHARING
PART V -MISCELLANEOUS
PART I FOR APPLICANTS WHO ARE INDIVIDUALS
PART II
FOR APPLICANT WHO ARE CORPORATE (ORGANIZATIONS)
PART III FOR ALL APPLICANTS
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