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Biosafety Act,
2011 Act
831
ARRANGEMENT OF SECTIONS
Section
Scope, objectives and
establishment
1.Scope
of the Act
2.Objectives
of the Act
3.Establishment
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.Confidential
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.Withholding
information
26.Appeals
Tribunal
Technical advisory committee
27.Technical
advisory committee
28.Functions
of the committee
29.Allowances
30.Conflict
of interest
Regulatory agencies
31.Functions
of regulatory agencies
32.Unintentional
release into the environment
Inspections
33.Appointment
of inspectors
34.Functions
of inspectors
Finance
35.Funds
of the Authority
36.Investment
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
INFORMATION REQUIRED IN
APPLICATIONS FOR CONTAINED OR
CONFINED USE
THlRD SCHEDULE
INFORMATION REQUIRED IN
APPLICATIONS FOR RELEASE,
IMPORTATION AND PLACING ON THE
MARKET
FOURTH SCHEDULE
RISK ASSESSMENT
FIFTH SCHEDULE
REGULATORY AGENCIES
ACT
OF THE PARLIAMENT OF THE
REPUBLIC OF GHANA
ENTITLED
BIOSAFETY ACT, 2011
AN ACT to regulate biotechnology
and to provide for related
matters.
DATE OF ASSENT:
PASSED by Parliament and
assented to by the President:
Scope, objectives and
establishment
Scope of the Act
1.
(1) The requirements 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
biotechnology that may have an
adverse effect on health and the
environment, and
(b)
to establish a transparent and
predictable process to review
and make decisions on
genetically modified organisms
specified in paragraph (a)
and related activities.
Establishment
of the
National Biosafety Authority
3. (1) There is established by
this Act a body corporate to be
known as the National Biosafety
Authority.
(2) Where there is a hindrance
to the acquisition 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 State Lands Act,
1962 (Act 125) and the cost
shall be borne by the Authority.
Functions of the Authority
4.
The functions of the Authority
are
(a)
to receive, process, respond to
and to make decisions on
applications under and in
conformity with this Act,
(b)
to establish administrative
mechanisms to ensure the
appropriate handling and storage
of documents and data in
connection with the processing
of applications and any other
matters covered by this Act,
(e)
to act as the national focal
point responsible for liaising
with any other agency or
international organisations
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 governing body of the
Authority is a Board consisting
of (a) an expert in
biotechnology and related
biological sciences including
biosafety, as the chairperson,
(b)
the chairperson of the technical
advisory committee established
under section 27,
(e)
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 representative of
non-governmental organisations,
(g) the chief executive
officer of the Authority,
(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 Scientific and
Industrial Research not below
the rank of a Director,
(j)
one representative of the
Ministry of Food and Agriculture
not below the rank of a
Director,
(k)
one representative of the
Ministry of Health not below the
rank of a Director, and
(/) one representative from the
Customs Division of the Ghana
Revenue Authority,
(2) The members of the Board
shall be appointed by the
President in accordance with
article 70 of the Constitution
and shall hold office for three
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 officio
members. (5) The names of
the members of the Board shall
be published as a notice in the
Gazette.
(6) The Board is responsible for
the proper and efficient
performance of the functions of
the Authority.
(7) The Minister responsible for
Science may give policy
directives to the Board.
Administration
Conduct
of business and affairs of the
Board
6.
(1) The provisions relating to
the conduct and regulation of
the business and affairs of the
Board are set out in the First
Schedule
(2) Except as provided in the
First Schedule, the 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 Minister in
consultation with the Minister
responsible for Finance.
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 performance
of a function of the Authority
under this Act.
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 environment
12. (1) A person shall not
introduce into the environment a
genetically modified organism
without the prior written
approval of the Authority.
(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, import or place
on the market a genetically
modified organism.
(2) An application 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.
(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, import or place
on the market a genetically
modified organism.
(2) An application 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.
Confidential information 16.
(1) The Authority
(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
confidentiality;
(b)
shall decide whether it accepts
as confidential the information
designated as confidential by
the applicant;
(e)
shall inform the applicant of
its rejection of the claim of
confidentiality, providing
reasons on request, as well as
an opportunity 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 information.
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
information.
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.
(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.
(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. (l) 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.
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.
(4) The members of the Appeals
Tribunal shall hold office for
three
years.
(5) A person who is aggrieved by
(a)
a refusal to grant an approval
under this Act, or (b)
the conditions 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
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
TecbmUcaladvisoryconurnnttee
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
orgamsms,
(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) Plant 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.
(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.
Functions of the committee
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 guidelines.
(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
subcommittee 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.
(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. (1) A regulatory 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 information
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 use
of the genetically modified
organism.
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 information for the
Board to undertake a risk
assessment.
(3) The Board, in consultation
with the regulatory 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 biosafety 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.
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 circumstances;
(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 appropriate 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.
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
performance 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 financial 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.
(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 last 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.
(3) Despite subsections (I) and
(2), the Authority may issue
guidelines in respect of the
matters referred to in
subsections (1) 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 imprisonment of not less
than five years and not more
than ten years or to both the
fine and 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 releases confidential
information for a purpose not
authorised by or under this Act,
or
(e)
uses a genetically modified
organism for mischievous or
unethical purposes, 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 of res on able diligence
as ought in the circumstances to
have been exercised to prevent
the commission of the offence.
(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;
"confmed 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;
"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
costeffective measures to
prevent environmental
degradation;
"Regulations" means the
Regulations made under this Act;
and "regulatory agency" means a
regulatory agency specified in
the Fifth Schedule.
SCHEDULES
FIRST SCHEDULE
(Section
6)
PROVISIONS AS TO THE CONDUCT OF
BUSINESS AND AFFAIRS OF THE
BOARD
Committees and co-opted advisers
1. (1) The Board shall establish
the committees it considers
appropriate to perform the
functions and e:x;ercise the
responsibilities determined by
the Board.
(2) The findings of a committee
shall be presented to the Board
for its consideration 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 appointment, 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
infirmity, incapable of
performing the functions of
office as a member of the Board;
or
(f)
on the commission of an offence
under this Act.
(2) A member of the Board may
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.(1)
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, directly 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.
(l) 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.
SECOND SCHEDULE
(Section
11)
INFORMATION REQUIRED IN
APPLICATIONS FOR CONTAINED OR
CONFINED USE
1. An application to conduct
activities under contained or
confined use with genetically
modified organisms under
contained use shall be submitted
to the Authority 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,
(f) 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.
THIRD 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.N
arne, 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.
4.Intended
date of the transboundary
movement.
5.Taxonomic
status, scientific and technical
names, common name, unique
identifier, transformation code
or event point collection or
acquisition and characteristics
of the recipient organism or
parental organism related to
biosafety.
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.Taxonomic
status, common name, point of
collection or acquisition and
characteristics of the
modification introduced, the
technique used and the resulting
characteristics of the
genetically modified organism.
8.Intended
use of the genetically modified
organism and the products of the
genetically modified organism.
9.Quantity
or volume of the genetically
modified organism to be
transferred and released.
10.The
appropriate risk assessment
report.
11.Suggested
methods for the safe handling,
storage, transport and use,
including procedures for
unintentional or accidental
release.
12.A
sworn declaration of the
applicant that the above
mentioned information is
factually correct.
FOURTH SCHEDULE
(Section
12, 13, 19)
RISK
ASSESSMENT
Objective of risk assessment
1.
The objective of the risk
assessment is to identify and
evaluate the potential adverse
effects of genetically modified
organisms on health and the
environment.
13.Use
of risk assessment
2.
The risk assessment shall be
used by the Board to make
informed decisions regarding
genetically modified organism.
3. The general principles
guiding risk assessment are,
(a)
risk assessment shall be carried
out in a scientifically sound
and transparent manner and may
take into account expert advice
and guiding principles developed
by relevant organisations;
(b)
lack of scientific knowledge or
scientific consensus shall not
necessarily be interpreted to
indicate a particular level of
risk, an absence of risk or an
acceptable risk; and
(c)
risk associated with genetically
modified organisms or products
of these organisms shall be
considered in the context of the
risk posed by the genetically
modified organism's recipient or
the parental organisms in the
likely potential receiving
environment.
Methodology
4. To fulfill its objective,
risk assessment shall entail
(a)
an identification of any of the
genotypic and phenotypic
characteristics associated with
genetically modified organisms
that may have an adverse effect
on the environment;
(b)
an evaluation of the likelihood
of these adverse effects being
realised, taking into account
the level and the kind of
exposure of the likely potential
receiving environment of the
genetically modified organism;
(c)
an evaluation of the
consequences should these
effects be realised;
(d)
an estimation of the overall
risk posed by the genetically
modified organisms based on the
evaluation of the likelihood and
consequences of the identified
adverse effects being realized;
(e)
a recommendation as to whether
or not the risks are acceptable
or manageable, including
identification of strategies to
mange the risk; and
(f)
where there is uncertainty
regarding the level of risk, the
Board may request further
information on the specific
issues of concern or may
recommend appropriate risk
management strategies and
monitoring of the genetically
modified organisms in the
receiving environment.
Points to consider
5. Risk assessment shall take
into account the relevant
technical and scientific details
regarding the characteristics
of,
(a) recipient organisms or
parental organisms:
the biological characteristics
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 characteristics of the
inserted nucleic acid and the
function it specifies and
characteristics of the
modification introduced;
(e) genetically modified
organisms:
identity of the genetically
modified 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.
FIFFH SCHEDULE
(Section 31)
REGULATORY AGENCIES
1.The
Food and Drugs Board
2.The
Veterinary Services Directorate
3.The
Plant Protection and Regulatory
Services Directorate
4.The
Environmental Protection 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:
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