Biosafety Act, 2011 Act 831 
ARRANGEMENT OF SECTIONS 
Section 
Scope, objectives and establishment 
1. Scope of the Act 
2. Objectives of the Act 
3. Establish ment of the National Biosafety Authority 
4. Functions of the Authority 
5. The governing body 
Administration 
6. Conduct of business and affairs of the Board 
7. Delegation of powers of the Authority 
8. Chief executive officer 
9. Staff of the Authority 
10. Protection from personal liability 
Handling of requests for approvals 
11. Application for contained or confined use 
12. Application for introduction into the environment 
13. Application to import or place on the market 
14. Application to export 
15. Genetically modified organisms in transit 
16. Confidentia l information 
17. Acknowledgement of application 
18. Gazette publication 
19. Risk assessment and risk management 
20. Exemption 
21. Determination of application 
22. Communication of decision 
23. Register 
Reviews and approvals 
24. Review of approval 
25. Withholdin g information 
26. Appeals Tribunal 
Technical advisory committee 
27. Technical advisory committee 
28. Functions of the committee Act 831 Biosafety Act, 2011 
29. Allowances 
30. Conflict of interest 
Regulatory agencies 
31. Functions of regulatory agencies 
32. Unintentional release into the environment 
Inspections 
33. Appointm ent of inspectors 
34. Functions of inspectors 
Finance 
35. Funds of the Authority 
36. Investm.ent of funds 
37. Financial year 
38. Annual estimates 
39. Accounts and audit 
Miscellaneous 
40. Regulations 
41. Offences and penalties 
42. Public· awareness and participation 
43. Civil liability and redress 
44. Interpretation 
SCHEDULES 
FIRST SCHEDULE 
CONDUCT OF BUSINESS AND AFFAIRS OF THE 
BOARD 
SECOND SCHEDULE 
INFORMA TION REQUIRED IN 
APPLICATIONS FOR CONTAINED OR CONFINED USE 
TlllRD SCHEDUL E 
INFORMATION REQUIRED IN APPLICATIONS FOR 
RELEAS E, IMPORTATION AND PLACING ON THE 
MARKET 
FOURTII SCHEDULE 
RISK ASSESSMENT 
FIFTH SCHEDUL E 
REGULA TORY AGENCIES 
2 Act 831 
THE EIGHT HUNDREDAND TmRTY-FIRST 
ACT 
OF THE PARLIAMENT OF THE REPUBLIC 
OF GHANA 
ENTITLED 
BIOSAFETY ACT, 2011 
AN ACT to regulate biotechnolo gy and to provide for related matters. 
DATE OF ASSENT: 31st December, 2011. 
PASSED by Parliament and assented to by the President: 
Scope, objectives and establishment 
Scope of the Act 
1. (1) The requiremen ts of this Act are in addition to, and not in 
derogation of, the requirements imposed by any other enactment. 
(2) This Act does not apply to genetically modified organisms that 
are pharmaceuticals for human use, and which are the subject of any 
other enactment. 
Objectives of the Act 
2. The objectives of the Act are, 
(a) to ensure an adequate level of protection in the field of 
safe development transfer, handling and use of genetically 
modified organisms resulting from biotechno logy that may 
have an adverse effect on health and the environment, and 
3 I Act 831 Biosafety Act, 20i I 
(b) to establish a transparent and predictable process to review 
and make decisions on genetica lly 1"11qd'fed organism s 
specified in paragraph (a) and related activities. 
Establishment of theN ational Biosafety Authority 
3. (1) There is established by this Act a body corporate to be known 
as the N a tiona! Biosafety Authority . 
(2) Where there is a hindrance to the acquisiticJn of property by the 
Authority, the property may be acquired for the Authority under the State 
Property and Contracts Act, 1960 (C.A. 6) or the St::t.te Lands Act, 1962 
"' (Act 125) and the cost shall be borne by the Authority. 
Function s of the Authority 
4. The func.-;,:Jn ,>f the Autl,L'r·t) ,_f' 
(a) to receive, process, respond to and to make decisiOns on 
applications under and in contoimity with this Act, 
(b) to establish administrative mechanisms to ensure the 
appropriate handling and storage of documents and data 
in connection with the processin g of applications and any 
other matters covered by this Act, 
(c) to (tet as the national focal point re'-ponsible for liaising 
\"i it~ any otter ;1gcc.q c.r i,·.t~r-r,at; •. m •. d. Oiganisations 
concerned with biotechnology and biosafety, and 
(d) to promote public awareness, participation and education 
concerning the activities of the Authority under this Act. 
The governing body 
5. (1) The goveming body of the Authority is a Board consisting of 
(a) an expert in biotechnology and related biological sciences 
wcluding biosafety, as the chairperson. 
(b) the chairperson of the technical advisory committee 
eqtablished under section 27, 
(c) one representative of the Ministry responsible for Science 
not below the rank of Director, 
(d) one representative of the Association of Ghana Industries, 
(e) one legal practitioner of not less than ten years standing, 
who has a sufficient background knowledge relevant to the 
subject matter of this Act. 
(f) one representativ e of non-governmental organisations, 
(g) d,c chief executi,·e officer 0f the Anr nitv, 
4 Biosafety Act, 20 I I Act 831 
(h) two members from the academia who are persons with a 
sufficient background knowledge relevant to the subject 
matter of this Act at least one of whom is a woman, 
{i) one representative of the Council for Scientifi c and 
Industiial Research not below the rank of a Director, 
(j) one representative of the Ministry of Food and Agriculture 
no• below the rank of a Director, 
(k) one representative of the Ministry of Health not below the 
rank of a Director, and 
(/) one representativ e from the Customs Division of the Ghana 
Revenue Authority . 
(2) The 'T'"mh,~r" 0f .. he P._..,ard shall be appriwcJ 1ly the President 
in accordance with article 70 of the Constitution and shall hold office for 
rhree years. 
(3) A member of the Board is eligible for reappointment for a further 
term not exceeding three years. 
(4) Subsections (2) and (3) do not apply to the ex offido members. 
(5) The names of the members of the Board shall be published as a 
notice in the Gazette. 
( 6) The Board lS responsible tor the proper and efficient performanc e 
of the functions of the Authority. 
(7) The Minister responsible for Science may give policy directives 
to the Board. 
Admmistration 
Conduct of business and affairs of the Board 
6 •. (1) The provisions relating to the conduct and regulation of the 
business and afrairs of the Board are set out in the First Schedule 
(2) Except as provided in the First Schedule, d1e Board shall regulate 
its own procedure and the procedure of any of its committees. 
(3) The Authority shall pay to members of the Board allowances 
approved by the Mini.c;ter in co,.,c;ult"ltiOTl with the 11finic;'"er responsible 
for Fmance. 
Delegation of powers of the Authority 
7. Subject to this Act, the Board may, generally or in a particular case, 
delegate to a committee of the Board or to a member of the Board, or 
to an officer, employee or agent of the Authority, the performa nce of a 
function of the Authority under this Act. I Act 831 Biosafety Act, 2011 
Chief executive officer 
8. (1) There shall be a chief executive officer of the Authority. 
(2) The President shall appoint, in accordance with article 195 of the 
Constitution, the chief executive officer of the Authority, on the terms 
and conditions of service stated in the instrument of appointment . 
(3) The chief executive officer shall hold office for a period not 
exceeding five years and is eligible for re-appointment for another term 
only. 
(4) The chief executive officer is responsible, subject to the direction 
of the Board, for the day to day management of the affairs of the 
Authority. 
Staff of the Authority 
9. The President shall appoint for the Authority, in accordance with 
article 195 of the Constitution, the officers and any other staff necessary 
for the proper performance of its functions under this Act, on the terms 
and conditions of service determined by the Board. 
Protection from personal liability 
10. A matter or thing done by a member of the Board or by an 
officer, employee or agent of the Authority, shall not, if the matter or 
thing is done bona fide in the· performance of a function of the Authority, 
render the member, officer, employee or agent personally liable to an 
action, a claim or demand. 
Handling requests for approval 
Application for contained or confined use 
11. ( 1) A person shall not conduct a contained or confined use activity 
involving genetically modified organisms or their development without 
the written approval of the Authority. 
(2) The application shall include 
(a) the details that are set out in the Second Schedule, and 
(b) any other additional information that the applicant may 
consider necessary for an assessment of the potential risk 
and benefits of the requested activity. 
Application for introduction into the environmen t 
12. (1) A person shall not introduce into the environment a 
genetically modified organism without the prior written approval of the 
Authority. 
6 Biosafety Act, 2011 Act 831 
(2) A person wishing to introduce a genetically modified organism 
into the environment shall submit to the Authority an application 
describing the activity for which the approval is sought. 
(3) An application under subsection (2) shall include 
(a) the information set out in the Third Schedule, 
(b) a risk assessment as set out in the Fourth Schedule, 
(c) a sworn declaration that the information contained in the 
application is factually correct, and 
(d) any other additional information that the applicant may 
consider necessary for an assessment of the potential risks 
and benefits of the requested activity. 
(4) An applicant may withdraw the application at any time prior 
to the issuance of a final decision by the Authority. 
Application to import or place on the market 
13. (1) A person shall not, without the prior written approval of the 
Authority, imrort or place on the market a genetically modified organism. 
(2) An~pplication under subsection (1) shall include 
(a) the information set out in the Third Schedule, 
(b) a risk assessment as set out in the Fourth Schedule, and 
(c) any other information that the applicant may consider 
necessary for an assessment of the potential risks and benefits 
of the requested activity. · 
Application to export 
14. A person intending to export a genetically modified organism shall 
provide the Authority with a written advance informed agreement or the 
appropriate certification from the competent authority of the importing 
country. 
Genetically modified organisms in transit 
15. (1) A person intending to transport a genetically modified organism 
through the Republic which is not destined for use in the Republic 
(a) shall apply to the Authority for a written approval for the 
transportation, and 
(b) shall ensure that the genetically modified organism is properly 
packaged and transported in accordance with the 
· Regulations and international standards. 
(2) An application to transport genetically modified organisms 
through the Republic shall be in the form prescribed by the Regulations. I Act 831 
Confidential information 
16. (1) The Authority Biosafety Act, 20 II 
(a) shall allow an applicant to designate information provided 
to the Authority in accordance with the requirements of 
this Act and the Regulations as confidential information, 
and the applicant shall supply the justification for the claims 
of confidential ity; 
(b) shall decide whether it accepts as confidential the informa­
tion designated as confidential by the applicant; 
(c) shall inform the applicant of its rejection of the claim of 
confidentiality, providing reasons on request, as well as an 
opportuni ty for consultation; and 
(d) shall, where an applicant withdraws an application, respect 
the applicant's claims of confidentiality . 
(2) The Authority shall not use confidential information for a 
purpose not authorised under this Act and shall ensure that the 
information is protected by the person involved in handling applications 
under this Act. 
Acknowledgement of application 
17. ( 1) On receipt of the application, the Authority 
(a) shall acknowledge in writing, the receipt of the application 
within seven days of the receipt, and 
(b) shall screen the application for completeness within sixty 
days. 
(2) Where an application is not complete, the Authority shall 
request the applicant to submit additional informatio n. 
Gazette publication 
18. (1) The Authority shall within fourteen days publish in the Gazette, 
a notice concerning an application for release into the environment, for 
the general information of the public. 
(2) On request, the Authority may avail to a person portions of 
an application which do not qualify as confidential informatio n. 
Risk assessment and risk management 
19. (1) Where an application is screened and found to be complete, 
the Board shall act in accordance with the advice of the technical advisory 
committee in respect of the risk assessment conducted as set out in the 
Fourth Schedule. 
·8 Biosafety Act, 2011 Act 831 
(2) Risk assessment shall be carried out taking into account 
available information concerning a potential exposure to the genetically 
modified organism. 
(3) The Board may request an additional risk assessment. 
( 4) On completion of the risk assessment , the Board shall 
(a) make a report giving its decision and the justification on the 
disposition of the application, and 
(b) indicate the measures to be taken to ensure the safe use of the 
genetically modified organism . 
(5) The Board shall liaise with the appropriate regulatory agency 
to ensure that measures are in place to manage and control risks identified 
during the risk assessment process. 
Exemption 
20. The Board may exempt a genetically modified organism from 
certain requirements of section 11, 12, or 13, where it is satisfied that 
sufficient experience or information exists to conclude that the genetically 
modified organism or activity does not pose a significant risk to the 
environment. 
Determination of the application 
21. In reaching a final decision on an application , the Board shall 
take into account 
(a) information submitted by the applicant , 
(b) the risk assessment report, 
(c) relevant comments submitted by the public, and 
(d) socio-economic considerations arising from the impact of 
a proposed activity and of the genetically modified 
organisms on the environment. 
Communication of decision 
22. (1) The Board shall communicate its final decision to the applicant 
(a) as soon as possible, but in any case not later than one 
hundred and eighty days after the receipt of the complete 
application, or 
(b) within the time that the Board may in special circumstances 
determine. 
(2) The approval shall set out clearly the specific conditions related 
to the approval. 
9 I Act 831 Biosafety Act, 2011 
(3) The approval shall be specific and limited to the activity 
authorised as set out in the decision document. 
Register 
23. The Authority shall maintain a register, which shall contain a copy 
of 
(a) the application, 
(b) the risk assessment report, 
(c) the decision document, 
(d) the approval, and 
(e) any other information the Board may consider necessary. 
Reviews and approvals 
Review of approval 
24. (1) The Board may review a decision made under section 21 at 
any time on obtaining significant new scientific information indicating 
that the genetically modified organism or the approved activity may 
adversely affect human health, ·plant health, animal health or the 
environment. 
(2) A regulatory agency or an applicant may request the Board to 
review the Board's decision under section 21 with respect to an activity 
conducted by the applicant on the ground 
(a) that a change in the circumstances has occurred that may 
have a material effect on the outcome of the risk assessment 
on which the decision was based; or 
(b) that additional scientific or technical information is 
available which may have a material effect on the decision 
including the conditions, limitations or requirements 
imposed under an approval. 
(3) Where on a review the Board is satisfied that a change is 
warranted, the Board shall issue a revised approval. 
( 4) The Board shall take a decision on a review within one hundred 
and fifty days from the date of notification of the review and shall set out 
the reasons for the decision. 
(5) Where the Board has knowledge that an activity possesses 
potential risk to the environment, the Board shall take immediate action 
to put the necessary measures in place. 
(6) The Board shall give special consideration for review requests 
from a regulatory agency. 
10 Biosafety Act, 2011 Act 831 
Withholding information 
25. (1) A person who withholds information 
(a) which becomes available to the applicant after the approval 
of the application , and 
(b) which could change the evaluation of risk posed by the 
intended activity of the person 
commits an offence and is liable on summary conviction to a fine of not 
less than two thousand five hundred penalty units and not more than five 
thousand penalty units or to a term of imprisonment of not less than five 
years and not more than ten years or to both the fine and the term of 
imprisonment. 
(2) Where an applicant has information which the applicant ought 
to have disclosed with the application , but does not do so, the applicant 
commits an offence and is liable on summary conviction to a fine of not 
less than two thousand five hundred penalty units and not more than five 
thousand penalty units or to a term of imprisonment of not less than five 
years and not more than ten years or to both the fine and the term of 
imprisonment. 
Appeals Tribunal 
26. (1) There is hereby established an Appeals Tribunal consisting of 
(a) an eminent biological scientist as the chairperson, 
(b) one legal practitioner of not less than ten years standing 
with professional qualifications in biotechnology or 
biosafety matters; and 
(c) three other members , who have qualifications in 
biotechnology and biosafety management at least one of 
whom is a woman. 
(2) The members of the Appeals Tribunal shall be appointed by 
the Minister and the appointments shall be published in the Gazette. 
(3) A member of the Board shall not be appointed a member of 
the Appeals Tribunal. 
years. ( 4) The members of the Appeals Tribunal shall hold office for three 
(5) A person who is aggrieved by 
(a) a refusal to grant an approval under this Act, or 
(b) the condition s of approval under this Act, or 
(c) the revocation, suspension or revision of an approval under 
this Act, or 
(d) a refusal to treat an application as confidential 
11 I Act 831 Biosafety Act, 2011 
may appeal, within thirty days of the decision of the Board, to the 
Appeals Tribunal in the prescribed manner. 
(6) A person aggrieved by a decision of the Appeals Tribunal may, 
within thirty days of the decision, appeal against the decision to the High 
Court. 
Technical advisory committee 
Technical advisory committee 
· 27. (1) In addition to any other committees that the Board may 
establish under the First Schedule, there is hereby established a technical 
advisory committee consisting of not more than eleven persons appointed 
by the Board for a period not exceeding three years as follows: 
(a) one representative each from 
(i) the Council for Scientific and Industrial Research, 
and 
(ii) the Atomic Energy Commission, 
(b) two persons one of whom is a woman, who are persons 
knowledgeable in the fields of science applicable to ecology 
and the development and release of genetically modified 
organisms, 
(c) two persons one of whom is a woman who are 
knowledgeable in socio-economic matters and genetically 
modified organisms, and 
(d) one representative each from the 
(i) Ghana Revenue Authority, 
(ii) Environmental Protection Agency, 
(iii) Food and Drugs Board, 
(iv) Veterinary Services Directorate, and 
(v) Pla11t Protection and Regulatory Services 
Directorate. 
(2) The Board in consultation with the Minister.responsible for 
Science shall in appointing members to the committee, endeavour to 
achieve representation from a range of the sciences relevant to genetically 
modified organisms and ecology. 
(3) The Board shall designate a member of the committee as the 
chairperson of.the committee. 
(4) In the absence of the chairperson, the members of the 
committee shall elect one of their number to act as chairperson. 
12 Biosafety Act, 2011 Act 831 
(5) The acting chairperson shall perform the functions of the 
chairperson where the chairperson is unable to do so. 
(6) A member of the committee whose period of office has expired 
is eligible for reappointment. 
Funotionsoftheconrurndttee 
28. (1) The technical advisory committee shall 
(a) act as the national advisory body on matters concerning or 
related to genetic modification of organisms, and carry out 
risk assessment and audit of applications at the request of 
the Board, and 
(b) advise, on request or of its own accord, the Minister and 
through the Board and the Minister advise the Ministries 
and appropriate bodies, on matters concerning the genetic 
modification of organisms including 
(i) aspects relating to the introduction and development 
of genetically modified organisms into the 
environment, 
(ii) proposals for specific activities or projects 
· concerning genetic modification of organisms, 
(iii) aspects concerning the contained use of genetically 
modified organisms, 
(iv) the importation and exportation of genetically 
modified organisms, and 
(v) proposed Regulations and written guideline s. 
(2) The committee shall annually submit a budget to the Board. 
(3) The committee may appoint subcommittees to deal with 
specific matters as required. 
Allowances 
29. The members of the technical advisory committee and of a sub­
committee shall be paid the allowances determined by the Minister, in 
consultation with the Minister responsible for Finance. 
Conflict of interest 
30. (1) A member of the technical advisory committee who has an 
interest, directly or indirectly in a matter which is the subject of 
consideration by the committee shall disclose that fact to the committee 
and the nature of the interest and shall not take part in the consideration, 
discussion of or vote on a question in respect of that matter. 
13 _.: 
I Act 831 Biosafety Act, 2011 
(2) A member who fails to comply with subsection (1) ceases to be 
a member of the committee . 
Regulatory agencies 
Functions of regulatory agencies 
31. (I) A regulator y agency shall, where appropriate, monitor an 
applicant's activities to ensure that those activities comply with the 
requirements of this Act, the Regulations and the conditions imposed in 
connection with the approval under this Act. 
(2) Where a regulatory agency becomes aware of significant new 
scientific info'rmation indicating that approved activities with genetically 
modified organisms may adversely affect the environment or pose potential 
risks not previously known, the regulatory agency shall immediately 
inform the Authority of the new information and of the measures put in 
place to ensure the continued safe usc of the genetically modified 
orgamsm. 
Unintentional release into the environment 
32. (1) A regulatory agency with knowledge of an unintentional or 
unapproved introduction into the environment of a genetically modified 
organism that is likely to have an adverse effect on the environment, shall, 
within twenty four hours of having that knowledge, notify the Authority 
of the occurrence . 
(2) A notification under subsection (1) shall include adequate in­
formation for the Board to undertake a risk assessme nt. 
(3) The Board, in consultation with the regulator y agency, shall 
determine whether an action is necessary to minimize an adverse effect 
on the environment. 
Inspections 
Appointment of inspectors 
33. (1) Subject to subsection (5) of section 19, the Board may appoint 
a duly qualified person as a biosafcty inspector of the Authority, for the 
area of authority specified in the letter of appointment. 
(2) The appointment of an inspector under subsection (1) shall be 
published in the Gazette. 
(3) An individual or a company incorporated in the Republic may 
be appointed as an inspector. 
14 I 
l Biosafety Act, 2011 Act 831 
Functions of inspectors 
34. (1) A biosafety inspector may, in the performance of a function 
under this Act, at a reasonable time and without a warrant, 
(a) enter any premises, vessel or property, which the inspector has 
reason to believe it is necessary to enter, in order to ascertain 
whether the requirements of this Act or of the Regulations 
are, or an approval under this Act is, being complied with, 
and may be accompanied by a person duly authorised by 
the Authority; 
(b) take possession of the equipment or material required for 
the purpose for which the power to enter is being exercised; 
(c) carry out the tests and inspection and make the recordings 
that are necessary in the circumstance s; 
(d) direct that a part of the premises, or anything in the premises, 
shall be left undisturbed for so long as it is reasonably 
necessary for the purposes of the test or inspection; 
(e) take $1ppropriate samples of the organisms, articles or 
substances found in the premises, an analysis or any other 
thing relevant for the purposes of this Act; 
(f) in the case of anything found in the premises which appears 
to contain genetically modified organism which has 
adversely affected or is likely to adversely affect the 
environment, the biosafety inspector may cause it to be 
dismantled or subjected to a process or test but not so as to 
damage or destroy it, unless it is necessary; or 
(g) require the production of the records which are required to 
be kept under this Act. 
(2) In the performance of a function under this Act, a biosafety 
inspector shall supply the appropriate identification. 
(3) An inspector who without reasonable cause acts in 
contravention of a provision of subsections (1) and (2) commits. an offence 
and is liable on summary conviction to a fine of not less than two thousand 
five hundred penalty units and not more than five thousand penalty units 
or to a term of imprisonment of not less than five years and not more 
that ten years or to both the fine and the term of imprisonment. 
15 Act 831 Biosafety Act, 2011 
Finance 
Funds of the Authority 
35. The funds of the Authority include 
(a) the moneys appropriated by Parliament for the purposes 
of the Authority, 
(b) the moneys that accrue to or vest in the Authority in the per­
formance of its functions under this Act, and 
(c) the moneys from any other source provided for, donated 
or lent to the Authority. 
Investment of funds 
36. The Authority may 
(a) invest any of its surplus funds in securities, and 
(b) place on deposit with a bank approved by the Minister 
responsible for Finance the moneys not immediately 
required for the purposes of the Authority. 
Financial year 
37. The financial year of the Authority shall be the same as the financial 
year of the Government. 
Annual estimates 
38. (1) Before the commencement of each financial year, the Board 
shall prepare the annual estimates of revenue and expenditure of the 
Authority for the fmancial year. 
(2) The annual estimates shall make provision for the estimated . 
expenditure of the Authority for the fmancial year concerned and in 
particular, shall provide for · 
(a) the acquisition, maintenance , repair and replacement of 
the equipment and any other property of the Authority, 
(b) the payment of salaries, allowances and any other charges 
in respect of the staff of the Authority, and 
(c) the payment of pensions, gratuities and any other charges 
in respect of retirement benefits which are payable out of 
the funds of the Authority. 
Accounts and audit 
39. (1) The sums of money provided in the estimates shall not be 
increased without the prior consent of the Board. 
16 Biosafety Act, 2011 Act 831 
(2) The Authority shall keep proper books and records of account 
of the income, expenditure , assets and liabilities of the Authority in the 
form approved by the Auditor-General. 
(3) Within three months from the end of the financial year, the 
Board shall submit for audit to the Auditor-General the books and 
accounts of the Authority together with 
(a) a statement of the income and expenditure of the Authority 
on the la~t day of that year, and 
(b) a statement of the assets and liabilities of the Authority on 
the last day of that year. 
( 4) The accounts of the Authority shall be audited and reported 
on in accordance with article 187 of the Constitution. 
(5) The activities and operations of the Authority shall be 
accessible to the public unless there are reasons of commercial 
confidentiality or security, justifying exclusion. 
Miscellaneous 
Regulations 
40. (1) The Authority may, witH the prior approval in writing of the 
Minister, and in consultation with the Ministers responsible for Health 
and Food and Agriculture and any other relevant sector Minister make 
Regulations , by legislative instrument, for the better performance of its 
functions under this Act and in particular for prescribing 
(a) anything required by this Act to be prescribed; 
(b) the procedures for conducting contained and confined use 
activities involving genetically modified organisms; 
(c) the procedures for 
(i) the release of genetically modified organisms into 
the environment, 
(ii) the importation of genetically modified organisms, 
(iii) the exportation of genetically modified organisms, 
(iv) genetically modified organisms in transit; 
(d) the procedures for appeals to the Appeals Tribunal; 
(e) the forms to be used for applications for approvals; 
(f) the schedules of fees to cover administrative costs of 
processing applications and notices; and 
(g) the procedures for deregulation. 
(2) Until Regulations are made under subsection·( 1 ), the Biosafety 
(Management of Biotechnology) Regulations, 2007 (L.I. 1887) shall 
continue in force as if made under this Act. 
17 Act 831 Biosafety Act, 2011 
(3) Despite subsections (1) and (2), the Authority may issue 
guidelines in respect of the matters referred to in subsections (I) and (2). 
Offences and penalties 
41. (I) A person commits an offence and is liable on conviction to a fine 
of not less than two thousand five hundred penalty units and not more 
than five thousand penalty units or to a term of imprisonme nt of not less 
than five years and not more than ten years or to both the fine a~d the 
term of imprisonment if that person 
(a) makes contained or confined use, releases into the 
environment, places on the market, imports or exports, a 
genetically modified organism without the approval of the 
Authority, or 
(b) contravenes a condition attached to an approval under this 
Act, or 
(c) fails to furnish an information as required by or under this 
Act, or 
(d) uses or relea~es confidential information for a purpose not 
authorised by or under this Act, or 
(e) uses a genetically modified organism for mischievous or 
unethical purpose s, or 
(f) obstructs or fails to assist the Authority or officers of the 
Authority in the performance of a function under this Act, 
or 
(g) contravenes any other provision of this Act. 
(2) Where a body corporate is convicted of an offence specified 
in subsection (1) a Director and any other officer of that body corporate 
shall be deemed to have committed the offence for which the body 
corporate is convicted. 
(3) A person shall not be convicted of an offence pursuant to 
subsection (2) where it is proved to the satisfaction of the Court that, 
having regard to the nature of the offence, 
(a) that person did not consent to, or did not conninve at, the 
commission of the offence, or 
(b) that person did exercise the degree ofresonable diligence as 
ought in the circumstances to have been exercised to prevent 
the commission of the offence. 
18 Biosafety Act, 2011 Act 831 
(4) For the purposes of subsections (2) and (3), a body corporate 
includes a firm or partnership and those subsections shall be construed 
accordingly in the case of a firm or partnership. 
Public awareness and participation 
42. (1) The Authority shall promote public awareness participation 
and education concerning biosafety matters for the benefit of the people 
of the Republic through 
(a) the publication of this Act and of the Regulations in as 
many languages as possible, and 
(b) public lectures, seminars and workshops. 
(2) The Authority shall publish notices of final decisions 
concerning applications made under this Act in the Gazette and the 
electronic and print media. 
Civil liability and redress 
43. Liability or redress for a damage that occurs as a result of an activity 
under this Act is subject to the applicable laws. 
Interpretation 
44. In this Act, unless the context otherwise requires, 
"Appeals Tribunal" means the Appeals Tribunal established 
under section 26; 
"applicant " means a person who submits an application 
pursuant to a provision of this Act; 
"Authority" means the National Biosafety Authority established 
under section 3; 
"biotechnology" means a technological application that uses 
biological systems, living organisms or derivatives of those 
systems and organisms to make or modify products or 
processes for a specific use; 
"biosafety" is a term used to describe efforts to reduce and 
eliminate the potential risks resulting from biotechnology 
and its products; 
"confined use" means a field trial of a genetically modified 
organism in an open system in which physical barriers are 
employed to effectively limit their impact with, and their 
impact on, human and external environment; 
19 Act 831 Biosafety Act, 2011 
"contained use" means an activity undertaken within a facility, 
an installation or any other physical structure which involves 
genetically modified organisms that are controlled by 
specific measures; · 
"genetically modified organism" includes an organism that has 
been transformed by the insertion of one or more genes, or 
regulatory elements, or an organism that has had its own 
genes modified without the insertion of any new genes and 
their products; 
"genetically modified organisms register" means the register 
maintained under section 23; 
"Minister" means the Minister responsible for Science; 
"placing on the market" means making a genetically modified 
organism available on a commercial basis; 
"precautionary approach" means that where there are threats 
of serious or irreversible damage, lack of full scientific 
certainty shall not be used as a reason for postponing cost­
effective measures to prevent environm ental degradation; 
"Regulations" means the Regulations made under this Act; and 
"regulatory agency" means a regulatory agency specified in the 
Fifth Schedule. 
SCHEDULES 
20 Biosafety Act, 2011 
FIRST SCHEDULE 
(Section 6) Act 831 
PROVISIONS AS TO THE CONDUCT OF BUSINESS AND 
AFFAIRS OF THE BOARD 
Committee s and co-opted advisers 
1. ( 1) The Board shall establish the committees it considers appropria te 
to perform the functions and exercise the responsibilities determined by 
the Board. 
(2) The findings of a committee shall be presented to the Board 
for its considera tion and determination. 
(3) The Board may at any time co-opt a person to attend any of its 
meetings, but a co-opted person is not entitled to vote on a matter for 
decision by the Board. 
Vacation of office 
2. (1) The appointment of a member of the Board, other than an ex-
officio member, shall be terminated by the President 
(a) on the expiry of the appointmen t, or 
(b) on the death of the member, or 
(c) if the member 
(i) is adjudged bankrupt , or is sentenced for an offence 
to a term of imprisonment of not less than six 
months, or 
(ii) is convicted of an offence involving fraud, 
dishonesty or moral turpitude, or 
(iii) is absent, without the permission of the Board, from 
three successive meetings of the Board for which 
the member has received notice; 
(d) on notice in writing of the intention to resign from office; or 
(e) if in the opinion of the Board, the member becomes by 
reason of mental or physical infrrmity , incapable of 
performing the functions of office as a member of the 
Board; or 
(f) on the commission of an offence under this Act. 
21 Act 831 Biosafety Act, 20 II 
(2) A member of the Board m~y resign at any time from office in 
writing addressed to the President through the Minister. 
(3) The President may by letter addressed to a member revoke the 
appointment of that member. 
( 4) Where a member of the Board is, for a sufficient reason, unable 
to act as a member, the Minister shall determine whether the inability 
would result in the declaration of a vacancy. 
(5) Where there is vacancy, the Minister shall notify the President 
of the vacancy and the President shall appoint a person to fill the vacancy. 
Meetings of board 
3. (I) The Board shall meet at least four times in every financial year. 
(2) The chairperson shall preside at the meetings of the Board, and 
in the absence of the chairperson, the members present shall elect one of 
their number to preside at the meeting. 
(3) Unless a unanimous decision is reached, a decision on a matter 
before the Board shall be determined by a majority of the votes of the 
members present and voting, and in the case of an equality of votes, the 
chairperson or the member presiding shall have a casting vote. 
(4) The quorum for the transaction of the business of the Board is 
seven members of the Board but in respect of financial matters or any 
other matter of importance as determined by the Board, the quorum 
shall be nine members. 
Disclosure of interest 
4. A member of the Board who has an interest, <ijrectly or indirectly, 
in an application or any other matter which is the subject of consideration 
by the Board shall disclose the fact to the Board and shall not take part in 
the consideration or discussion of or vote on, a question in respect of 
the application or that other matter. 
Seal of the board 
5. (1) The seal of the Authority shall be authenticated by the signatures 
of the chairperson of the Board and the chief executive officer of the 
Authority. ·· 
(2) In the absence of the chairperson, a member of the Board 
designated by the chairperson for the purpose may authenticate the seal. 
22 Biosafety Act, 2011 Act 831 
SECOND SCHEDULE 
(Section 11) 
INFORMATI ON REQUIRED IN APPLICA TIONS 
FOR CONTAINED OR CONFINED USE 
1. An application to conduct activities under contained or confined 
use with geneticall y modified organisms under contained use shall be 
submitted to the Authmity at least sixty days before the activities are due 
to begin. 
2. The application shall include 
(a) the name and contact address of the applicant, 
(b) the location where the contained use activities are to be 
undertaken, 
{c) the nature and identity of the genetically modified organisms 
to be involved, 
(d) the nature and purpose of the activities including storing, 
transporting, producing , processing, disposing or use of the 
genetically modified organisms in any other way, 
(e) a description of the potential risks associated with the 
genetically modified organism activities to be undertaken, 
(/) a description of the potential risk associated with genetically 
modified organism activities to be undertaken, and 
(g) a description of the remedial measures to be undertaken for 
unintentional release at the end of the acitivity. 
TillRD SCHEDULE 
(Sections 12, 13) 
INFORMATION REQUIRED IN APPLICATIONS FOR RELEASE, 
IMPORTATION AND PLACING ON THE MARKET 
1. N arne, address and contact details of the exporter. 
2. Name, address and contact details of the importer. 
3. Name and identity of the genetically modified organism as well as 
the domestic classification of the biosafety level of the genetically 
modified organism in the country of export. 
23 ·I Act 831 
4. Intended date of the transboundary movement . 
5. Taxonomic status, scientific and technical names, common name, 
uniqre identifier, transforr1aron "'ode or event point collection or 
acquisition and characteristic!) of the recipient organism or parental 
organism related to biosafcty. 
6. Center of origin and center of genetic diversity, of the recipient 
organism and the parental organism and the description of the 
habitat where the organism is related to biosafety . 
7. Taxrnomic status, corPr on n? c. point of collection or 
acqu1sition and charact "stil \,)i (l · .. iddif tL· l,l irttroduced, the 
tecll' •que used and the re •J1'lllg charaeteri:-. 1i ·~ uf the genetically 
modified organism. 
8. Intcrded use ofthe geneticcth· n 1di11ed organ1sm and the products 
of t ' ~ genetically modit'1n; cu · '"'· ., .. 
9. Qu:rrtity or volume of r1lf' gt,nrrirally modified organism to be 
tram terred and released 
10. The 'ppropriate risk assessiP• '' fl·pn t. 
11. Suggested methods for the r:a~ b~rdling, storage transport and 
use, 1ncluding procedures fnr .,,.; ... t.,nf-ional or accidental release. 
12. A sworn declaration of the 'PPlic.:art rhat the above mentione d 
info1 mation is factually cr w -:~· 
FOUR-_ 
RISF P SS :~:)Si {ENT 
Objective t.f risk assessmen t 
1. The 0bjective 0fthe risl-a'5CS ncnr = n id,·n ·1) "nd evaluate the 
potential aciverse effects of genetically mnd!li<.!d c;rg~nisms on health and 
the environmem . 
Use of risk assessment 
2. The risk assessment shall be used 0' th.: Board to make informed 
decisions regarding genetica11y n'lf rl ''i r ' • -1. Act 831 
3. The general pnncirlt.": guici 1g rislc assessment arc, 
(a) risk assessmrnt shall be carried out in a scientifically sound 
and transpiH''t1f· manner and may take into account expe1t 
advice and nuiding principles developed hy relevant 
organisa tio·1~. 
(b) lack of scientific knowledge or scientific consensus shall not 
necessatily be 'nterpreted to indicate a particular level of 
risk, an ab··l.!r-....:e of r'~k cr an acceptab le risk; and 
(c) risk c;.~so~iatcd with gcn~ tically modified c··ganisms or 
produ<..:ts of thf'St: J:·aan: '"0:3 shall be considered in the 
cunit' ·' ul 11 •.. i .. ~ ., •:, .. ! by the gene"'i"all :-' modified 
UI~,t P.i:..,. 1
' I . I""!. l'' f'', f•l!COtal OrganJS'Tl.$ ;., the likely 
potential n., 1\ ··tg environmen t. 
Methodology 
4. To fulfill its ob_l,.rtivc, rist' ;s"essmcnt shall entail 
(a) an ide .-; '; ~ en of : .. ny of +t1r. g<"notypic and phenotypic 
char~ctetistics asstYlii"ed rvith genetically modified 
orwmi ,_ ~ that m<~.l' hav<" ?n adverse ef:-ccr on the 
(', '1 )t t f'~ "\fo 
(b) an cvaluai.iun oftl· c li~(e!lh ood of these ad' erse · 'fects being 
realised, t~king into account the level and the kind of 
exposure of the likely potential receiving environment of 
the gcnetiral ly modified organism; 
{c) an evaluc;, ·on of '}e c0n~eq uences should the'e effects be 
realised: 
(d) an estimation of the overall risk posed by the genetically 
modified organisms based on the evalua:ion of the 
likelihoo d and consequenc es of the identified ac verse effects 
being realized; 
(e) a recommenda tion as to whether or not the risks are 
acceptable or managea ble, including identification of 
strategies to rr· ·mge the risk; and 
(f) where 'hc,..c is urrertainty regarding the level of risk, the 
Board may request further information on the specific issues 
of conc"m or nn.y recommend appropriate risk 
manageme nt strategies and monitoring of the genetically 
modified organisms in the receiving cnvironn1ent . Act 831 Biosafety Act, 2011 
Points to consider 
S. Risk assessment shall take into account the relevant technical and 
scientific details regarding the characteristics of, 
(a) recipient organisms or parental organis~: the biological char­
acteristics of the recipient organism or parental organism 
including taxonomic status, common name, origin, centers 
of origin and centers of genetic diversity and a description 
of the habitat where the organism persists; 
(b) donor organism: taxonomic status and common name, 
source and the relevant biological characteristics of the 
donor organisms; 
(c) vector: characteristics of the vector including its identity of 
origin and host range; 
(d) insert and characteristics of modification: genetic characteri stics 
of the inserted nucleic acid and the function it specifies and 
characteristics of the modification introduced; 
(e) geneticafly modified organisms: identity of the genetically modi­
fied organisms and the differences between the biological 
characteristics of the genetically modified organisms and 
those of the recipient organism or parental organisms; 
(f) detection and identification of genetically modified organisms: 
suggested detection identification methods and the 
specificity, sensitivity and reliability; 
(g) information relating to the intended use: information related 
to the intended use of the genetically modified organisms 
including new or changed use compared to the recipient 
organism or parental organism; 
(h) receiving environment: information , the location, geographical 
climatic and ecological characteristics including relevant 
information on biological diversity and centers of origin 
of the likely potential receiving environment. 
26 Biosafety Act, 2011 
F'IFTH SCHEDUL E 
(Section 31) 
REGULATORY AGENCIES 
1. The Food and Drugs Board 
2. The Veterinary Services Dir~cto rate Act 831 
3. The Plant Protection and Regulatory Services Directorate 
4. The Environmental Protecti on Agency 
5. The Customs Division of the Ghana Revenue Authority 
6. District Assemblies, Metropolitan Assemblies, Municipal 
Assemblies and any other local government authority 
7. The Standards Authority. 
Date of Gazette notification: 31st December, 20 1r 
27 GOVERNMEN T PRINTER, ASSEMBLY PRESS, ACCRA. GPCLIA510/350/I0/2011 
Website: www.ghanapublishing company.com E-mail: info@ ghanapubli shing compa ny.co~