1 
 2409 2018  L.I 
 
BIOSAF ETY (MANAGEMENT OF BIOTECHNOLOGY )  
REGULATIONS, 2018  
ARRANGEMENT OF REGULATIONS  
 
Regulations  
Institutional A rrangement s 
1. The National Focal Point  
2. Implementation r oles  
3. Memorandum of Understanding with regulatory a gencies  
4. Institutional biosafety c ommittee  
5. Certification of the institutional biosafety c ommittee  
6. Relationship between the institutional biosafety c ommittee  and the Authority  
7. Composition of the institutional biosafety c ommittee  
8. Functions of the institutional bio safety c ommittee  
9. Biosafety O fficer  
10. Principal Investigator  
 
Procedures  
11. Processing of a pplications  
12. Confidential i nformation  
13. Contained Use  or Confined Use  
14. Introduction into the e nvironment, p lacing on the m arket and  import  
15. Authorisation for placing on the m arket  
16. Export  
17. Transit  
18. Monitoring and enforcement  
19. Public awareness, participation and education  
20. Register  
21.  Biosafety Clearing House and i nformation  
22. Appeals Tribunal  2 
 23. Food s afety  
24. Cessation o rders  
25. Deregulation  
Miscellaneous  Provisions  
26. Fees  
27.  Interpretation  
28. Transitional provision s 
29. Revocation  
 
SCHEDULES  
FIRST SCHEDULE  
Guidelines on Institutional Biosafety Committees (IBCs)  
SECOND SCHEDULE  
Guidelines for Contained and Confined Use of Genetically Modified Organisms (GMOs)  
THIRD SCHEDULE  
Guidelines for the Administration of Biosafety Applications  
FOURTH SCHEDULE  
Guidelines for GMO Regulatory Compliance, Monitoring and Inspection  
 
 
 
 
 
 
BIOSAFETY (MANAGEMENT OF B IOTECHNOLOGY)  
REGULATIONS, 2018  3 
  
IN exercise of the powers conferred on the Authority with the prior appr oval in writing of the 
Minister  by subsection (1)  of Section 40 of the Biosafety Act, 2011 (Act 831) , and in 
consultation with the Ministers responsible for H ealth and Food and Agriculture , these 
Regulations are made this  ……………… day of ………………… …. 2018 . 
Institutional A rrangements  
The national focal point  
1. (1)The Authority as the national focal p oint in accordance with paragraph (c ) of section 
4 of the Act is responsible for the following:  
 
(a) liaising  with the Secretariat of the United Nations Convention on Biological 
Diversity for the  performance of the administ rative functions req uired under the 
Cartagena Protocol on Biosafety;  
(b)  informing other Parties to the Cartagena Protocol on Biosafety  of any b ilateral, 
regional or multilateral agreements and arrangements that Ghana has entered 
into before and after the date of entry into force of the  Protocol;  
(c)  the exchange of information and provision of information to other Parties to the 
Cartagena Protocol and other countries in relation to  
(i) biosafety and biotechnology;  
(ii) decisions and other administrative arrangements under the Act;  
(iii) development, trans fer, handling , use and other activities in respect of  
genetically modified  organisms within Ghana t hat may have significant  
adverse effects on the conservation and sustainable use of b iological 
diversity, taking  into account risks to human health; or activities that have 
or are likely to have significant adverse effects on the conservation and 
sustainable use of biological diversity or to human health;  
 
(d) notification and receipt of notification in relation to unintentional transboundary 
movements and emergency measures;  
(e) notification and receip t of notification under the Cartagena Protocol in relation to 
transboundary movements of genetically modified organisms and other related 
activities.  
 4 
 (2) In furtherance of  the functions conferred on the Authority in Section 4 of the 
Act, the Authority  may 
 
(a) facilitate training of scientists  and other persons in biosafety;  
(b)  suggest practical alternatives to high -risk laboratory procedures;  
(c) inform the various institutions engaged in biotechnological  work 
about new developments in biosafety in  order  to avoid ex posure of 
laboratory personnel, the community or the environment to undue 
risks;  
(d)  co-ordinate efforts between the relevant government agencies and 
private organizations to maintain safety levels in biotechnological 
work and to prepare them for emergencies ;  
(e) certif y laboratories , greenhouses and animal facilities  intended for 
high-risk work, and recommend additional measures  where 
necessary;  
(f) inspect high -risk laboratories and containment facilities on a regular 
basis in collaboration with  the de signated regulatory agencies,   
(g)  inspect laboratories and facilities of physical containment levels at 
any time after certification without prior notice; and 
(h) inspect  systems, equipment, vessels and instruments governing 
ambient biosafety levels in ge netic modification laboratories.   
Implementation r oles  
2. (1) The Authority  shall supervise the  implementation of biosafety practices in 
biotechnological work,  in collaboration with   
 
(a) the regulatory agencies specified in the Fifth Schedule to the Act,  
(b) the relevan t institutional biosafety commi ttees certified by the Board , and  
(c) the Principal Investigator.  
(2)  The organizations and persons specified in sub -regulation (1) shall, in 
addition to their functions  
(a)  pursue the common objective of supporting and preserving the integrity 
and the intent of these Regulations and any guidelines t hat may be 
issued under the Act;  and  5 
 (b)  promote and facilitate adherence to th ese Regulation s and any 
guidelines that may be issu ed under the Act for the safety of personnel, 
the community and the environment.  
 
(3) Where a person  fails to comply  with biosafety measures  prescribed by the 
Authority , whether deliberate or unintentional the Authority may  
(a) stop the work on issuing a not ice to show cause and request  
proper investigation through the relevant Institutional Biosafety 
Committee,  or 
(b) prescribe additional safety measures or conditions , or 
(c)  intervene in any other manner appropriate under the Act.  
 
Memorandum of Understanding with regulatory a gencies  
3. (1) In the performance of its functions, the Authority may ent er into an agreement 
through a M emorandum of U nderstanding with  
(a) regulatory agencies specified in the Fifth Schedule to the Act , and 
(b) other  persons, agencies or organizations not listed in the Act. 
 
            (2) The Memorandum of U nderstanding shall spell out cl early the areas of 
operation,  roles  to be performed  and the financial arrangements related to the execution of 
the specified roles .                                                
 
 
 
 
 
Institutional biosafety committee  
4.      (1) A public or private institution or  organization, engaged in, or with the intent to 
engage in the acquisition , development , propagation or field release of genetically modified 
organisms or  products of genetically modified organisms  for purposes of research shall  
(a) each establish an institutional biosafety c ommittee ; and  6 
 (b) suppor t the needs and demands of the c ommittee for the effective 
performance of its functions . 
     (2) Despite  sub-regulation (1) , an institution  which is unab le to constitute its own 
institutional biosafety committee may request any other institutional b iosaf ety c ommittee to 
help monitor and supervise the biosafety aspects of its work.  
       (3)  A request  under sub regulation ( 2) shall be  in the form of a  writte n 
Agreement entered into betwee n the parties involved and the Authority shall  be notified of 
the Agreement.  
       (4) A representative of the institution requesting assistance  shall ma intain close 
ties with the respective institutional biosafety c ommittee or serve  as a member on the 
supporting institutional  biosafety c ommittee.  
Certification of the institutional biosafety c ommittee  
 
 5. (1) The Authority  shall  
              
(a) prepare and provide to the institutional biosafety committees, the 
various notification and assessment forms, appropriate guidelines 
and any other relevant documents;  
(b) provide assistance to the i nstitutional biosafety com mittees and 
advise them on the various notification and assessment forms, 
biosafety guidelines and any other relevant documents;  
 
(c) certify each institutional biosafety committee  to undertake 
monitoring functions for contained use and confined use activities for 
certain levels of clas sified risks to be issued periodically through 
guidelines;  
(2)  For th e purposes of certification , the completed notifi cation forms of an 
institutional biosafety c ommittee, detailing the academic and professional history of each 
mem ber appointed to the Committee shall contain information relating to  
 
  (a)  members of the institutional biosafety committee,  
  (b)  the designated biosafety officer where applicable,  
  (c)  a list of the current projects indicating the risk assessment  category,  7 
 (d)  a list of the laboratories approved for biotechnological  work indicating 
the category of containment, and  
(e) a list of the institution's greenhouses and animal facilities, certified and 
intended for work w ith genetically modified organisms  indicating 
category of containment.  
 
Relationship between the institutional biosafety c ommittee  and the Authority  
 6.       (1) Work classifi ed as "minimal risk" and "low risk" shall be assessed, and 
approved by the institutional biosafety committee, with written notice to the Authority.  
(2) Work involving higher level of risk shall be  assessed  and approved by the 
Authority.  
Composition of the i nstitutional biosafety c ommittee  
7.          An Institutional Biosafety C ommittee shall include   
(a) four members of the institution with expertise in biosafety regulation and the 
environmental effects of biotechnolog ical work ; 
(b) the  biosafety officer of the institution  
    (c) representatives  from cognate organ izations or institutions;  
               (d) two members who are not affiliated with the institution and representing the  
                    interest of the community such as  
 
(i) members of government, public h ealth or environmental 
agencies.  
(ii) persons active in huma n, plant or animal health concern s, and  
(iii) persons active in environmental concern s, and who do not 
require a previous a ffiliation with the institution.  
     (e) The head of the institution shall appoint members of the institutional biosafety 
committee and shall designate a chairperson and a secretary for the effective performance of  
the functions of the committee.  8 
  
Functions of an  institutional biosafety c ommittee  
8.  (1)  In order to enforce the appropriate guidelines issued by the Authority, an 
institutional biosafety committee shall  
                (a)  monitor the regulated work under progress within the institution and counsel                
                         the proponents on issues of biosafety and on compliance with the Act and the                          
appropriate guidelines on a regular basis, or as requested;  
(b)  report infractions to the institutional head or to the Authority and recomme nd to  
                      the institutional head or the A uthority to stop a biosafety activity  if its  
                      continuation under     
                     the existing circumstances, is a threat to the public, the environment or      
                     laboratory personnel;  
(c) determine additional biosafety measures  and draft supplementary  
 terms and conditions for work at the institution, in line with and addressing the 
specific risks and concerns identifi ed;  
               (d) assis t researchers in undertaking risk analysis ; 
     (e) organize training program mes for staff of the institute and other  
                    stakeholders ; 
(f) set apart time for researchers and for laboratory and field personnel to 
approach the committee with questions, disputes or concerns;  
 
(g) maintain and update a directory of the personnel engaged in activities at 
every biosafety level, and instruct new personnel on the correct laboratory 
or field practices, emergency procedures and equipment operation at the 
relevant levels; and 
 
(h)  where appro priate, serve as a gateway for the flow of information, ideas and 
opinions among  the Authority, the research teams and all stakeholders.  9 
  (2)  To ensure that biotechnological  work within the institution conforms to these 
Regulations  and the appropriate guidelines issued by the Authority , the institutional biosafety 
committee shall 
(a) assess biosafety applications referred to the committee, and on the basis of the 
information provided determine under which category of  
work the applications  fall and whether t o endorse the work for approval ;  
 
(b) maintain records of approved biosafety applications  for laboratory 
biotechnological  work, including notification for exemption and the        
assessment  of the  committee;  
 
 
(c) forward the biosafety applications  submitted for notification and the 
committee’s assessments to the Authority for records and information or for 
review and recommendation in the case of applications classified as higher 
risks, for risk assessment as specified in the National Biosafety Gui delines ;  
 
(d) undertake risk  assessment  and risk management,  in co -operation with the 
research teams as necessary to determine the appropriate containment and 
biosafety terms and condition s, standard operating procedures and emergency 
safeguards as specified  in the appropriate guidelines ;  
 
(e) in collaboration with the research teams, specify contingency plans after  
undertaking risk assessments and reviewing biosafety applications ;  
 
(f) ensure compliance with the terms and conditio ns stipulated by the Authority on 
approval of an application;  
 
(g) facilitate inspection and certification of the appropriate level of laboratories, 
greenhouses  and animal  facilities , before use in biotechnological  work;  
 
 
(h) monitor and assess the integrity of containment facilities , and th e working 
conditions  10 
 within the laboratories, greenhouses and animal facilities supporting the  
institution's work to ensure that the various facilities are maintained at the  
standards and requirements outlined in the appropriate guidelines for 
laborator y and field work;  
 
 
(i) facilitate preparation of dossiers for submission to the Authority for the  
conduct of laboratory  and field work ; and 
 
(j) as required by the Authority, report on work being undertaken in the institution.  
 
.       
 Biosafety Officer  
  9. (1)  An institution or organization involved in biotechnological  work shall appoint a 
Biosafety Officer to serve on the institutional biosafety c ommittee.  
      (2)  In addition to the f unction specified in sub -regulation  (1) of Regulation 8 , the Biosafety 
Officer , in conjunction with the institutional biosafety committee , shall  
(a) review the standard operating p rocedures and biosafety records;    
(b) assess the integrity of containment facilities and safety equipment or utilities ; 
and  
(c) investigate and re port incidents  and infractions  to the Authority  in a timely    
manner . 
 
Principal Investigator  
10.     (1) A Principal Investigator is responsible for submitting an application to  the 
institutional biosafety committee  for approval.    
 (2) The Principal Investigator shall use the appropriate guidelines to  
(a) submit a completed biosafety applications  to the supervising institutional 
biosafety committee for co nsideration and recommendations;  and  
(b) inform  the committee of any notable intent such as plans to import 
regulated material.  11 
   (3)  Biotechnological  work may begi n after authorisation from the institutional 
biosafety committee as directed by the Authority, and the Principal Investigator may be 
required to provide additional details of the research for  assessment  and monitoring activities 
of the institutional biosafety committee.  
 (4) The Principal Investigator shall comply with the provisions  of the appropriate 
guidelines  and the terms and cond itions  of approval throughout the duration of the research  
in addition to ,  
(a) ensuring  that person s entering controlled areas have been properly instructed 
on applicable codes of conduct;  
 
(b) co-operating closely with the institution al biosafety committee and the Biosafety 
Officer in carrying out various safety tests and, monitoring of containment 
facilities;  
 
 
(c) informing the institutional biosafety committee  of details of the contingencies 
and the emergency measures  put in place to deal with incidents  
 
 
Proced ures 
Processing of a pplications  
11. (1)    Where a person formally submits an application to the Authority, it shall be recorded 
and a tracking numb er assigned to the dossier in order  to systematically keep track of the 
application.  
 .  
 (2)  Where an application is recorded, it  shall b e screened for completeness, to check  
whether the application complies with information  required . 
 
(3)  Where it is concluded that the request is in compliance w ith the information required  
under sub -regulation ( 2) the risk assessment included in the dossier shall be 12 
 reviewed by the technical advisory committee,  as a scientific process, based on the 
best available and up to date, scientific knowledge and data . 
           (4) The Authority shall consider the application and communicate its  decision  as set 
out in Sections 21 and 22 of the Act.  
Confidential i nformation  
12. (1) Where an applicant satisfies the Authority that the information specified in the 
application  
 (a)  is a trade secret, or  
(b)  has a commercial or other value that would be, or  could reasonably be 
expected to be, destroyed or diminished if the information was disclosed, or  
(c) has other information that  
(i)  concerns the lawful commercial or financial affairs  of a person, 
organi zation  or undertaking, and  
(ii) if it were disclosed, could unreasonably affect the person, organi zation 
or undertaking,  
the Authority shall declare that the information is confidential infor mation for the  
purposes of the  Act.  
(2)  Subject to Section 16(1)(d ) of the Act, the Authority may refuse to declare that 
the information is confidential if the Authority is satisfied that the public interest in disclosure 
outweighs prejudice that t he disclosure would cause to a  person.  
(3)  Subject to Section 16(1)(d) of the Act, the Authority may, by written notice given 
to the applicant, revoke a  declaration under sub  regulation (1) , if the Authority is satisfied that  
the 
  (a)   information concerned  no lon ger satisfies sub -regulation 1 , or  
(b)   public  interest in disclosure outweighs prejudice that the disclosure 
would cause to any person.  
(4) For the purposes of sub -regulation (1), the Authority shall not consider as 
confidential,  13 
   (a)  the name and address of the applicant,  
  (b)  a general descr iption of the genetically modified organism,  
(c)  a summary of the risk assessments performed on the genetically 
modified organism, and  
  (d)  any methods and  plans for emergency response.  
Contained Use or  Confined Use  
 13.      (1) A person submitting an application under Section 11 of the Act for a permit for 
contained use activities shall, in addition to submitting the information set  out in the Second 
Schedule to  the Act, identify the risk classification of the proposed genetically modifie d 
organisms in accordance with the guidelines provided by the Authority.  
        (2)   The Auth ority may extend an  approval granted in sub regulation  (1) to a person 
to continue work with genetically modified organisms in the same risk classification witho ut 
further application s for a specified period .  
     (3)    A contained use activit y of a higher risk classification  other  than already 
authorised is  subject to approval under Section 11 of the Act  
(4) A person submitting an application under Section 11 of the Act for a permit for  a 
confined use activit y shall, in addition to submitting the information set out in the Second 
Schedule to the Act, submit a risk assessment as s et out in the Fourth Schedule to  the Act.  
 
 
Introduction into the environment, placing on the market and i mport  
14.      (1) An application under Section 12 of the Act , may be submitt ed together with an 
application under Section 13 to import the specified genetically modified organism for 
purposes of the proposed introduction into t he environment.  
 (2)  An approval issued for applications under Section 12 and 13 of the Act shall 
set out clearly the terms and conditions  that may be prescribed or imposed including  the 
following:  
(a) the scope of the activit ies authorized by the approval;  
 
(b) the purposes for which th e activities may be undertaken;  14 
  
(c) variations to the scope and purposes of the activities;  
 
(d) documentation and record -keeping requirements;   
(e) waste disposal requirements;  
(f) handling and transport;  
(g) storage ; 
(h) measures to manage risks pos ed to human health or the environment;   
(i) data collection, inc luding studies to be conducted;  
(j) auditing  and reporting;  and 
 
(k) controls to limit the spread and persistence of th e genetically modified 
organism;  and  
 
(l) contingency  plans.  
 
            (3)  The holder  of an approval may  
(a) with the consent of the Aut hority, surrender the approval,  or 
(b) jointly apply with another  person to the Authority to  transfer the   
approval from the  approval holder to that other person .  
  (4)  An application  under sub  regulation 3 (b) shall be in writing.   
            (5)      Where  the Authority decides to transfer the approval , the same terms and 
conditions shall apply as thos e in force immediately before the transfer.  
 
Authori sation for placing on the m arket  
15.       (1) A written approval granted by the Authority to an application for the placing on 
the market of a genetically modified organism shall be in the form of an authori sation for a 
speci fied period of up to ten years and  is renewable.  
(2)  An authori sation under sub regulation  (1) includes the possibility to import the 
authori sed genet ically modified organism.  
Export  15 
 16. For  the purposes of Section 14 of the Act, written documentation demonstrating that a 
genetically modified organism has been approved, permitted or authori sed by the country of 
import shall be considered as written advance informed agreement of the competent autho rity 
of the importing country.  
Transit  
17.  (1) An application to transport  genetically modified organism through t he 
Republic shall contain  
(a) the authori sation by the recipi ent country for the importation;  
 
(b)  a contingency plan in case of an  unintentional or  accident al              
 
          release ; and   
 
(c) the anticipated date of the movement  across the borders of Ghana 
and the respective entry or exit locations.  
(2) The application  shall be submitted to the Authority not less than fifteen wo rking 
days prior to the departure of the cargo from the exporting country.  
(3) An applicant handling genetically modified organism  in transit shall inform the 
Authority prior to the transb oundary movement of the genetically modified organism across 
the borders of Ghana.  
 (4)  The genetically modified organism  shall be transported on agreed terms and 
conditions specified by the Authority, and the instrument of agreement shall designate a 
specific entry or exit point manned by a certified regulatory officer.  
 (5)  The genetically modified organism  shall be accom panied by a c ustoms officer  
in collaboration with officials  of the designate d regulatory agency  specified in the Fifth 
Schedule  to the Act  to ensure safe transport across the border.  
 
Monitoring and enforcement  
18.      (1)    The Authority is  responsible for the overall monitoring, risk management and 
environmental  release of  genetically modified organism s.  16 
    (2)       The Principal Investigator shall condu ct the first tier of monitoring.  
  (3)      The institutional biosafety committee shall conduct the second tier of 
monitoring     
  (4) The third tier of monitoring, inspection and enforcement shall be performed by 
the Authority through  
(a) the regulatory agencies specified in the Fifth Schedule to the Act ; and  
 
(b) biosafety inspectors provid ed for in Sections 33 and 34 of the Act.  
 
 
 
Public awareness, participation and education  
  19.     (1)   The Authority shall publish on regular basis,  exemptions  granted under Section 
20 of the Act in the Gazette  and the electronic and print media.  
             (2)  In furtherance of  section 18(1) of the Act, a person  may submit a written 
comment on an application for release of a genetically modified organism within sixty days 
from the date of the publication of the notice in the Gazette .  
              (3)  A comment received by the Authority and any response by the Authority to 
the comment shall be made available to the public on request.  
 
Register  
20.    The Authority shall include in the register established under S ection 23 of the Act , a 
list of  
(a) a genetically modified organism for which authori sation is granted by the 
Authority including whether the genetically modified organism has been 
authori sed for placing on the market;  
 
(b) a genetically modified organism and activities that are exem pted or subject to 
simplified proced ures as determined by the Board;  and  
 17 
 (c) a genetically modified organism that is deregulated  as determined by the 
Board.  
 
 
Biosafety Clearing House and information  
21.       (1) The Authority is responsible for the management of the National Biosafety 
Clearing House established under the Ca rtagena Protoco l and shall fulfil its obligations 
under the Protocol . 
             (2) The Authority shall provide the Biosafety Clearing House with  
(a) a copy of these Regulations, including the amendments to the 
Regulations and any other legislation and national guidelines of 
relevance to the implementation of the Act or  the management 
of genetically modified organisms;  
 
(b) the summaries of risk assessments generated pursuant to these 
Regulations;  
 
(c) the final decision regarding the importation or intentional 
introduction in the environment or placing on the market of 
genetically modified organ isms and any  changes to a previous  
decision and the reasons for the changes within thirty days . 
 
(d) the reports concerning national implementation of the Cartagena 
Protocol in accordance with the Protocol; and  
 
(e) any other information required under the Cartagena Protocol . 
 
 
 (3) Where the Authority makes a final decision regarding domestic use, including placing on 
the market, of a genetically modified organism that may be subject to export for direct use as 
food or feed product  or for processing, it shall ensure that information concerning the 
authori sation of that organism , as specified in the appropriate guidelines for the release, 
importation and placing on the market , is provided to the National Biosafety Clearin g House 
within fifteen days of making the decision.  18 
 Appeals Tribunal  
22.     The Appeals Tribunal , established under  Section 26  of the Act,  shall consider  an 
appeal within  sixty days  on receipt of the appeal  and shall communicate its decision and the 
reasons for the decision in writing to the Authority and to the applicant.  
 
 
 
 
Food s afety  
23.        (1) The Authority shall liai se with the relevant regulatory a gencies with mandate to 
regulate food to ensure  safety of food derived from genetically modified organism s. 
             (2)      Where an application for placing on the market concerns a food or  feed product, 
the applicant shall include information concerning food and feed safety in its application  to 
the Authority  for consideration .  
             (3)     Where the Authority is satisfied with the information provided by the applicant  
under sub -regulation (2), the Authority shall approve the application and inform the applicant 
of its decision  
               (4)    Any genetically modified organism that has been approved by the Authority 
shall be published in the register and may be imported into the country for use as food, feed 
or for processing.  
Cessation orders  
24.     (1) The Authority may , in writing, issue a  cessation order, for an activity covered by an 
authori sation or which has been the subject of a notification,  to stop  if the Board determines 
that 
(a) there is a significant risk to human health  and the environment ; or 
 
(b)  the holder of the approval has not, or is not in a position to implement, 
adequate risk management measures to deal with that risk.  
           (2) For the purposes of sub reg ulation (1) the Authority shall take into account any 
(a)  breaches of  the terms and  conditions prescribed or imposed in the      19 
        approval;   
(b) tests conducted and evaluated in a manner consistent with  accepted 
scientific procedures;  or  
 
(c)  other validated scientific evidence.  
             (3)  The Authority may issue a cessation order on  the failure of  a holder of an 
approval  to demonstrate substantial compliance, after a reasonable period of time of  an order 
issued under these Regulations, or with respect to an authori sation granted or a notification 
submit ted under these Regulations whe re there exists a material infringement of a provision 
of these Regulations.  
    (4)  The Board shall withdraw a cessation order where the Board determines that 
sufficient information exists to permit the activity to resume in the absence of additional ri sk 
management measures without posing a significant risk to the conservation and sustainable 
use of biological diversit y, taking into account the risk to human health and the environment . 
Deregulation  
25.   (1) The Authority may , deregulate the handling and use of a  genetically modified 
organism approved for  introduction into the environment  or place ment  on the market  
(a) where the holder of an approval to introduce into the environment or place on 
the market a genetically modified o rganism  submits a petition to the Board ; or  
(b) on the a determination by the Board . 
. 
  (2)  The Authority shall deregulate  the handling and use of a gene tically modified 
organism where the Authority is satisfied that  
(a)  the risk s to human health or the environment posed by the genetically 
modified organism are minimal, and  
(b)  it is not necessary for persons handling and using the genetically 
modified organism to be covered by an approval, in order to protect 
human health and the environm ent.  
   (3)     For the purposes of making a decision , the Authority shal l have regard to the 
following:  20 
 (a) any data available to the Board about adverse effects posed by the 
genetically modified organism,  
 
(b) any advice given by the technical advisory committee,  
 
(c) any other information as to risks identified in previous approvals, and  
 
(d) any other matters that the Board considers relevant.  
(4) The decision  shall be in writing and shall come  into effect on the d ate specified in 
the decision .  
 (5)  A copy of the decision  to deregulate a ge netically modified organism shall  be 
placed on the register  in accordance with sub-section 23(e) of the Act.    
                                
                         Miscellaneous P rovisions  
Fees   
26.     (1)       An applicant shall pay the applicable fee for applications submitted to the 
Authority.  
(2)       In determining the fees payable for applic ations required  under the Act,  for  
inclusion in the Fees and Charges ( Miscellaneous Provision s) Act,.. the Board shall 
consider  
           (a)  the cost of processing by the Authority;  
           (b)  the cost of inspection;  
           (c)  the cost of the services from  any of the regulatory agencies; and  
           (d)  any other cost relevant matters . 
Interpretation  
27.  In these Regulations, unless the context otherwise requires,  
"Cartagena Protocol" means the Cartagena Protocol on Biosafety of the     
         United Nations Con vention on Biological Diversity;  21 
 "Principal Investigator" means a trained scientist with thorough knowledge in the  
                 codes, regulations and laws applicable to        
                      biotechnological work and exhibits an appreciation for the biosafety concerns        
                      and is recognized by the institution or organizatio n as the Principal     
                      Investigator;  
            “products of genetically modified organisms” means  processed materials that are of              
                     genetically modified organism origin, containing detectable novel combination s     
                     of replicable genetic material obtained t hrough the use of biotechnology; and  
"food or feed product ” mean s a genetically modified organism or its product that is     
                      used for food, feed or processing and is primarily intended for consumption by        
                       humans or animals or for the consumption of both humans and anima ls;  
 
Transitional provisions  
28.      (1) An application pending on the date of the coming into force of these 
Regulations is subject to these Regulations.  
(2) An application for approval shall be made in accordance with these Regulations for 
contained or confined use, introduction into the environment, to import or to place on the 
market of a genetically mod ified organism that has already been carried out prior to the 
coming into force of these Regulations.  
(3) An application under  sub regulation (2) s hall be submitted to the Authority within a 
time limit to be determined by the Authority.  
(4) Where the application has been made within the prescribed time limit the activity 
in respect of which the application is made may continue until a decision is made by the 
Authority.  
 
 22 
  
 
 
Revocation  
29. The Biosafety (Management of Biotechnology) Regulations, 2007 (L.I. 1887) and any 
previous guidance issued prior to the adoption of the Biosafety Act, 2011 (Act 831)  are hereby 
revoked .  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 23 
 Annex 1: Fee Schedule for Biosafety Applications in Ghana  
 ITEM  COST  
  GHS  USD  
1 Institutional Accreditation and 
Certification of Institutional Biosafety  
Committee (IBC)  16,810.79  3,909.49  
   
    
 Renewal of Institutional Biosafety  9,680.67  1,623.41  
 Committee (IBC) Certificate    
2 Facility Certification  6,100.00  1,418.60  
    
3 Renewal of Facility Certificate  3,600.00  837.20  
    
4 Confined Field Trial (CFT)  27,845.34  6,475.60  
    
5 Renewal of CFT Permit  5,587.09  1,299.32  
    
6 Environmental Release /placing on the 
market  54,940.93  12,776.96  
    
7 Renewal of Environmental/Commercial  15,351.60  3,570.14  
 Release Permit    
    
8 Appeals  7,612.84  1,770.43  
    
9 Transit  4,335.45  1,008.25  
    
10 Multi -Location Trials  42,866.88  9,969.04  
    
11 Renewal of Multi -Location Trial Permit  28,180.50  6,553.61  
    
12 Export / Import  15,370.90  3,574.63  
    
13 Contained Use  27,845.04  6,475.60  
    
14 Renewal of Contained Use permit  11,470.00  2,667.67  
15 Genetically Modified Free Status  2,000.00  465.12  
 Certificate