National Biosafety Authority-UNE–GEF host February 2018 Twangale Park Sensitization Workshop

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By Derrick Sinjela

The National Biosafety Authority (NBA) a Zambian statutory body established through the Biosafety Act No. 10 of 2007, will hold a sensitization and awareness workshop in conjunction with the United Nations Environment –Global Environment Facility from the 20th to 21st February, 2018 at Twangale Park, for selected key stakeholders in order to establish the Biosafety Clearing House (BCH) as a fully functional and effective platform for implementation of the Cartagena protocol.

According to National Biosafety Authority Communications Officer, Sandra Lombe-Mulowa the sensitization and awareness meeting aim is to consolidate and intensify cooperation toward achieving common goals and objectives in the use and operation of the BCH in Zambia.

Ms. Lombe-Mulowa says electronic and print media houses are expected to cover the official opening on Tuesday 20th February, 2018 at 09:00 hours, whose Guest of honour is Ministry of Higher Education PS Mr Mabvuto Sakala.

Regional Advisors from the United Nations Environment Programme (UNEP) Dr Ossama Abdel-Kawy (Egypt) and Ms Lillian Munyah Nfor (Cameroon) are equally expected to speak at the same event.

“The NBA’s mandate is to regulate genetic engineering activities and is the focal point for Biosafety Clearing House (BCH). The BCH is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) to which Zambia is party. The BCH provides global access to a variety of scientific, technical, environmental, legal and capacity building information. Zambia has operationalized the Protocol through the Biosafety Act No. 10 of 2007,” explained Ms. Lombe-Mulowa.

Ms. Lombe-Mulowa says Zambia has since operationalized the Convention through the Biosafety Act No. 10 of 2007 and the National Biosafety Authority is currently the focal point for Biosafety Clearing House.

Zambia’s key stakeholders will get a clear understanding of the common format of Biosafety Clearing House records, procedures for registering and publishing biosafety-related decisions; and technical national Biosafety Clearing House responsibilities, and impact on the institutional framework.

The National Biosafety Authority sensitization and awareness workshop goals include providing the Zambia’s key stakeholders; government representatives, industry, importers, producers, distributors, researchers, farmers and farming organizations outreach systems, major food and feed companies where appropriate, NGOs and civil society, and print and broadcast media) with a clear understanding of:

The first goal is seeking a  common format of BCH records as well as the procedures for registering and publishing biosafety-related decisions.

Secondly, providing the technical national BCH responsibilities, and impact on the institutional processes for creating and registering BCH information and making biosafety related decisions, for example- registering and publishing records.

Thirdly, the identification of National procedures and operational linkages to gather information to be put on BCH in line with NBFs implementation and sustainability and training plan; with workshop objectives being twofold; define procedure or mechanisms to flow information onto the BCH (para 2.1 in the SSFA) and how to define roles of Competent National Authorities and National Focal Points (Form 1).

The Zambian government has launched the National Biosafety Authority (NBA), whose core business is to regulate genetically modified organisms (GMOs) or products of GMOs in the country. The launch that took place on November 26, 2015 at Radisson Blu Hotel, in Lusaka was officiated by the Minister of Higher Education, Dr. Michael Kaingu who said that the National Biosafety Authority is now fully functional in order to ensure that Zambia benefits from the safe application and use of modern biotechnology.

“Safety will now be ensured in the development, use and handling of all gene modification technologies and products thereof because the NBA has put in place a system for notification and handling applications for permits and other key matters of biosafety,” Dr. Kaingu said. During a parliamentary meeting held on December 2, 2015, members of parliament were informed by Hon. Dr. Michael Kaingu, that the Authority will oversee GM crop research. “We are now on a clear path for the development of biotechnology. Our scientists are hard working to regulate and develop genetically modified crops, and we now have the capacity to regulate them,” said Dr. Kaingu.

He informed parliament that his ministry in collaboration with the ministry of agriculture, livestock and fisheries has been working hand in hand to put in place a biosafety frameworkand policy. The minister indicated that other ministries involved in biotechnology and biosafety policy formulation included the ministries of health, lands, natural resources and environmental protection as well as the ministry of local government and housing.

For more information on the Zambian National Biosafety Authority, contact Doris Musondaat dorismusonda@gmail.com.

THE BIOSAFETY ACT, 2007
ARRANGEMENT OF SECTIONS
PART I
PRELIMINARY
Section
1. Short title
2. Interpretation
3. Scope
PART II
THE NATIONAL BIOSAFETY AUTHORITY
4. Establishment of National Biosafety Authority
5. Functions of Authority
6. Scientific Advisory Committee
7. Functions of Scientific Advisory Committee
8. Composition of Scientific Advisory Committee
9. Institutional biosafety committees
PART III
REGULATION OF ACTIVITIES RELATING TO GENETICALLY
MODIFIED ORGANISMS
10. Prohibition of import, export, transit, etc of genetically
modified organism
11. No permit on crop or live stock of strategic importance
12. Prohibition of certain work on genetically modified organisms
13. Notification procedure
14. Public consultation, information and participation
15. Regulatory powers on public information, consultation and
participation
16. Decision making procedure
17. Permit conditions
18. Criteria for decision making
19. Socio-economic considerations
20. Appeal against refusal to grant permit
21. Revocation of permit
22. Appeal against revocation
23. Suspension, cancellation and loss of permit
PART IV
RISK ASSESSMENT
24. Risk assessment
25. Evaluation of risk assessment
26. Effect of refusal of authorisation on patents
Biosafety [No. 10 of 2007 141
PART V
RISK MANAGEMENT
27. Risk Management
PART VI
CO-EXISTENCE
28. Co-existence of farming practices
PART VII
IDENTIFICATION AND LABELLING
29. Packaging, identification and labelling
PART VIII
EXPORT
30. Procedure for export
PART IX
REQUIREMENTS FOR GENETICALLY MODIFIED ORGANISM IN TRANSIT
31. Requirements for genetically modified organisms in transit
32. Regulatory powers
PART X
UNINTENTIONAL RELEASE AND EMERGENCY RESPONSE MEASURES
33. Emergency response plan
PART XI
CONFIDENTIAL BUSINESS INFORMATION
34. Protection of certain business information
35. Protection of intellectual property rights
PART XII
LIABILITY AND REDRESS
36. Liability and redress
PART XIII
INSPECTORATE
37. Appointment of inspectors
38. Seizure, disposal and destruction of genetically modified
organism or product illegally imported, etc
142 No. 10 of 2007] Biosafety
39. Disposal of abandoned consignment
40. Costs for sterilisation, removal, destruction, etc
41. Powers of inspectors
42. Obstruction of inspector
43. Appeals against orders of destruction
PART XIV
APPEALS
44. Appeals tribunal
PART XV
OFFENCES AND PENALTIES
45. Offences and penalties
PART XVI
MISCELLANEOUS
46. Regulations
47. Transitional provisions
Biosafety [No. 10 of 2007 143
A BILL
ENTITLED
An Act to regulate the research, development, application,
import, export, transit, contained use, release or placing on
the market of any genetically modified organism whether
intended for use as a pharmaceutical, food, feed or
processing, or a product of a genetically modified organism;
ensure that any activity involving the use of any genetically
modified organism or a product of a genetically modified
organism prevents any socio-economic impact or harm to
human and animal health, or any damage to the
environment, non-genetically modified crop and biological
diversity; set and implement standards for the assessment,
evaluation and management of any potential risk involving
the use of any genetically modified organism or product of
a genetically modified organism; establish the National
Biosafety Authority and prescribe its powers and functions;
provide for the establishment of the Scientific Advisory
Committee; provide for public participation, information
and consultation in the field of biosafety; provide for a
mechanism for liability and redress for any harm or damage
caused to human and animal health, non-genetically
modified crop, socio-economic conditions, biological
diversity or the environment by any genetically modified
organism or a product of a genetically modified organism;
provide for the formation and registration of institutional
biosafety committees; and provide for matters connected
with or incidental to the foregoing.
[ 3rd May, 2007
ENACTED by the Parliament of Zambia
Biosafety [No. 10 of 2007 145
Enactment
GOVERNMENT OF ZAMBIA
ACT
No. 10 of 2007
I hereby signify my assent to the Bill
Signed……………………………
President
Date of Assent: 24th April, 2007
PART I
PRELIMINARY
1. This Act may be cited as the Biosafety Act, 2007, and
shall come into force on such date as the Minister may, by statutory
instrument, appoint.
2. In this Act, unless the context otherwise requires—
“ advance informed agreement ” means the consent obtained
before any activity is undertaken based upon full disclosure
of all relevant information and the taking of full
responsibility by the supplier of the information for its
accuracy and completeness;
“ applicant ” means any person making an
application for the approval of the Authority, or the person
to whom the approval is given;
“ Authority ” means the National Biosafety Authority;
“ biosafety ” means a set of measures, policies and procedures
used or established for assessing, preventing, monitoring
and managing any risk associated with genetically
modified organisms to human health and safety and to the
environment;
“ biotechnology ” means the development of products by
exploiting biological processes or substances using intact
original or modified organism or by using active cell
components;
“ Cartagena Protocol ” means the Protocol on Biosafety under
the Convention on Biological Diversity;
“ control ” means to examine, regulate, manage or direct any
activity within a person’s jurisdiction;
“ contained use ” means any operation in which
any genetically modified organism or product of a
genetically modified organism is produced, grown, stored,
destroyed or used in some other way in a closed system in
which physical barriers are employed, either alone or
together with chemical or biological barriers, to effectively
prevent its contact with, and its impact on, humans,
biological diversity and the external environment;
“ environment ” means the aggregate of
surrounding objects, conditions and influences that influence
the life and habits of man or any other organism or
collection of organisms;
“ export ” means the intentional transboundary movement of
any genetically modified organism or a product of a
genetically modified organism from one country to another
country;
146 No. 10 of 2007] Biosafety
Short title
and
commencement
Interpretation
“ exporter ” means any legal or natural person who arranges
for any genetically modified organism or a product of a
genetically modified organism to be exported;
“ genetically modified organism ” means any biological entity,
capable of replication or of transferring genetic material
or any plant, animal or microorganism, in which the genetic
material has been altered through modern biotechnology;
“ gene technology ” means any technique that involves the
isolation, characterisation, modification and introduction
of deoxyribonucleic acid (DNA) into living cells or
microorganisms;
“ gene therapy ” means the replacement of a defective gene
in a person or animal suffering from a genetic disease;
“ hazard ” means an intrinsic biological, chemical or physical
characteristic of a genetically modified organism, which
could lead to an adverse impact on the environment and
health;
“ import ” means the intentional transboundary movement
of any genetically modified organism or a product of a
genetically modified organism into one country from
another country;
“ importer ” means any legal or natural person who arranges
for any genetically modified organism or a product of a
genetically modified organism to be imported;
“ inspector ” means any person appointed as aninspector
under this Act;
“ microorganism ” means any cellular or non-cellular
microbiological entity that is able to reproduce or transfer
genetic material;
“ modern biotechnology ” includes the application of the
following techniques:
(a) any recombinant nucleic technique involving the
formation of new combinations of genetic material
by the insertion of nucleic acid molecules
produced by whatever means outside an organism
into a virus, bacterium, plasmid or other vector,
and their incorporation into a host organism in
which they do not naturally occur but in which
they are capable of continued propagation;
(b) any technique involving the direct introduction
into an organism of heritable material prepared
outside the organism including micro-injection,
macro-injection and micro-encapsulation; and
Biosafety [No. 10 of 2007 147
(c) any cell fusion, including protoplast fusion or
hybridisation techniques where live cells with new
combinations of heritable genetic material are
formed through the fusion of two or more cells;
“ monitoring ” means the maintaining of regular surveillance,
the checking of the warning about or the recording of a
situation or process;
“ notification ”means providing information to and, where
appropriate, the lodging or depositing of samples with the
Authority;
“ organism ” means a biological entity, cellular or noncellular,
capable of metabolism, replication, reproduction
or transferring genetic material and includes a
microorganism;
“ permit ” means a permit issued under this Act;
“ person” includes any research, university or other academic
institution;
“ placing on the market ” means supplying, selling,
advertising, donating or making available to any third party
of any genetically modified organism or product of a
genetically modified organism;
“ product ” means any material derived by processing, or
howsoever, from any genetically modified organism;
“ Registrar ” means a person appointed as Registrar under
this Act;
“ release ” means any intentional introduction into the
environment, of a genetically modified organism or a
product of a genetically modified organism for any
commercial purpose, food aid, remediation, research
purpose in any field experiment, use of a genetically
modified organism or a product of a genetically modified
organism in any greenhouse, aquaculture facility, animal
accommodation, unless the facility is approved for
contained use as part of an approved laboratory or other
installation, disposal of waste containing any genetically
modified organism or a product of a genetically modified
organism, the import, export or transport of any genetically
modified organism or a product of a genetically modified
organism;
“ risk ”means the probability of incurring or
causing a loss, injury, an adverse impact or a misfortune
on any human, plant or the environment;
148 No. 10 of 2007] Biosafety
“ risk assessment ” means an evaluation of any direct or
indirect, short, medium and long term risk to human or
animal health, the environment, biological diversity and
to the socio-economic conditions or ethical values of the
people of Zambia arising from the import, transit,
contained use, release or placing on the market of a
genetically modified organism or a product of a genetically
modified organism;
“ risk management ” means measures necessary to prevent
and manage adverse effects of any genetically modified
organism or product of a genetically modified organism
on human or animal health, non-genetically modified crop,
biological diversity, the environment, or socio-economic
conditions;
“ socio-economic impact ” means any direct or indirect effect
to the economy, social or cultural practices, livelihoods,
indigenous knowledge systems or indigenous technologies
as a result of the import, transit, contained use, release or
placing on the market of a genetically modified organism
or a product of a genetically modified organism;
“ trial release ” means the release of any genetically modified
organism into the environment in the open under conditions
where the degree of dissemination of the genetically
modified organism is prevented by chemical or physical
barriers or by built-in barriers which prevent the survival
of the organism in the environment;
“ Tribunal ” means the Tribunal established under this Act;
“ use ” excludes the acquisition by purchase or otherwise,
by a member of the general public or any utilisation or
dealing thereafter, unless specific conditions are attached
to the utilization;
“ user ” means any natural or legal person or institution
responsible for the use of a genetically modified organism;
and
“ waste ” means any matter, whether gaseous, liquid or solid
or any combination thereof, which is, in the opinion of the
person in whose possession or under whose control it is,
an undesirable or superfluous by-product, emission,
residue or remainder of any process or activity in
connection with any genetically modified organism.
3. This Act applies to the import, development, export,
research, transit, contained use, release or placing on the market
of any genetically modified organism whether intended for release
into the environment, for use as a pharmaceutical, for food, feed
or processing, or a product of a genetically modified organism.
Scope
Biosafety [No. 10 of 2007 149
PART II
THE NATIONAL BIOSAFETY
AUTHORITY
4. (1) There is hereby established the National Biosafety
Authority which shall be a body corporate with perpetual
succession and a common seal, capable of suing and being sued in
its corporate name, and with powers, subject to the other provisions
of this Act, to do all such acts and things as a body corporate may
by law do or perform and as are necessary for, or incidental to, the
carrying out of its functions under this Act.
(2) The provisions of the First Schedule apply to the Authority.
5. (1) The functions of the Authority are to—
(a) receive, respond to and make decisions on any
notification and application, in consultation with the
Scientific Advisory Committee, and in accordance with
the requirements of this Act;
(b) establish administrative mechanisms to
ensure the appropriate handling, dissemination and
storage of documents and data in connection with the
processing of applications and notifications and other
matters covered by this Act;
(c) promote public awareness and education
concerning the activities regulated under this Act,
through the publication of guidance and other materials
that explain and elaborate on the risk assessment, risk
management and authorization processes;
(d) establish and maintain a data base on genetically
modified organisms and products of genetically
modified organisms intended for direct use as food or
feed, or for research and production processing and
make available such information to the public;
(e) prescribe criteria, standards and guidelines as may be
necessary for the implementation of the provisions of
this Act;
(f) take into account the policy recommendations and other
guidelines of the Scientific Advisory Committee in
making decisions on the import, export, development,
transit, research, contained use, release or placing on
the market of any genetically modified organism or
product of a genetically modified organism;
Establishment
of National
Biosafety
Authority
Functions of
Authority
150 No. 10 of 2007] Biosafety
(g) to cause the establishment and appointment of members
of institutional biosafety committees at relevant
institutions and constitute any other organ of experts,
as appropriate, as technical and scientific advisors on
issues of biosafety;
(h) to keep any genetically modified organism or any
product of any genetically modified organism under
review and where the Authority has reasonable grounds
to believe that the genetically modified organism or
product thereof poses any risk to human and animal
health, biological diversity or the environment, to ban
its transit, import, export, development, research, use
or release in Zambia;
(i) review or have made a risk assessment of any genetically
modified organism or product of any genetically
modified organism;
(j) take any measures to protect human and animal health,
biological diversity and the environment from the risks
that may be posed by any genetically modified organism
or product of any genetically modified organism;
(k) designate inspectors and undertake inspection as well
as any other control measures to ensure compliance with
this Act; and
(l) carry out any other activity which is necessary or
conducive to the performance of its functions under this
Act.
(2) The Authority shall serve as the National Biosafety Focal
Point and receive, process and respond to information and
notifications from the Secretariat of the Cartagena Protocol on
Biosafety.
(3) In furtherance of its functions under subsection (2), the
Authority shall—
(a) facilitate regional and international information
exchange and sharing relating to genetically modified
organisms or products of genetically modified
organisms or any other matter connected therewith; and
(b) declare through the Secretariat of the Protocol that—
(i) any genetically modified organism or product of
a genetically modified organism intended as
food or feed or for processing shall be imported
only after it is subjected to a full risk assessment
in accordance with this Act; and
Biosafety [No. 10 of 2007 151
(ii) any application to import a genetically modified
organism or product of a genetically modified
organism shall require a risk assessment any
time a new genetically modified
organism is posted in the Clearing House under
the Protocol.
6. (1) There is hereby established a Scientific Advisory
Committee for the purpose of conducting risk assessments and
providing scientific and other technical advice and assistance to
the Authority.
(2) The Authority shall appoint the members of the Scientific
Advisory Committee.
(3) A member of the Scientific Advisory Committee shall hold
office for a period of three years and may be re-appointed for a
further like period.
(4) The office of a member becomes vacant—
(a) upon the member’s death;
(b) if the member is adjudged bankrupt;
(c) if the member is absent from three consecutive meetings
of the Committee of which the member has had notice,
without the prior approval of the Committee;
(d) upon the expiry of one month’s notice of the member’s
intention to resign from office, given by the member in
writing to the Authority;
(e) upon the expiry of one month’s notice of the member’s
removal given to the member in writing by the
Authority;
(f)if the member becomes mentally or physically incapable
of performing the duties of a member of the Committee;
(g) if the member is convicted of an offence under this Act;
(h) if the member is convicted of an offence under any other
written law and sentenced therefor to imprisonment for
a term of six months or more; or
(i)if the member acquires any interest in a biotechnology
enterprise or any commercial enterprise likely to benefit
directly from biotechnology or its products.
7. The Scientific Advisory Committee shall—
(a) conduct risk assessments;
(b) review risk assessment and risk management measures;
(c) recommend containment measures, limitations on the
duration of authorizations, reporting mechanisms,
remedial measures, monitoring procedures and other
appropriate and scientifically sound conditions and risk
management measures;
(d) provide policy recommendations and guidelines to the
Authority; and
(e) provide such other advice and assistance as the
Authority may request.
Scientific
Advisory
Committee
Functions of
Scientific
Advisory
Committee
152 No. 10 of 2007] Biosafety
8. (1) The Scientific Advisory Committee shall consist of nine
scientific experts from any of the following fields:
(a) breeding and genetics;
(b) agronomy;
(c) weed science;
(d) pathology;
(e) molecular biology;
(f) food science;
(g) toxicology;
(h) ecology;
(i) entomology;
(j) virology;
(k) microbiology; and
(l) pharmacology.
(2) The Chairperson of the Scientific Advisory Committee
shall be elected by members of the Committee.
(3) The Committee may, for the purpose of performing its
functions under this Act, constitute any sub-committees and
designate chairpersons of the sub-committees, who shall be drawn
from the members of the Scientific Advisory Committee.
(4) The Scientific Advisory Committee may appoint as
members of any sub-committee constituted under sub-section (3)
persons from any government agency, independent institution,
research institute, university or any other academic institution.
(5) The Scientific Advisory Committee may recommend to
the Authority the appointment of any additional members of any
sub-committee as may be required for purposes of this Act.
(6) The Scientific Advisory Committee may recommend the
appointment of any expert advisor from any relevant scientific
discipline not otherwise adequately represented on the Scientific
Advisory Committee or any sub-committee.
(7) A member or advisor of the Scientific Advisory Committee
or any sub-committee, shall publicly disclose any actual or potential
conflict of interest relating to any risk assessment or any other
matter upon which the Scientific Advisory Committee or any subcommittee
may be consulted by the Authority.
(8) Any person with any actual or potential interest with regard
to a particular matter which is the subject of discussion or
consideration by the Scientific Advisory Committee shall not
participate in any risk assessment, discussion or deliberation
concerning that matter and shall be removed from the Committee
or sub-committee where any actual or potential conflict impair the
person’s ability to serve in an independent or impartial manner.
(9) The Minister may, by statutory instrument, make
regulations for—
(a) the rules of procedure and the operations of the
Scientific Advisory Committee and any sub-committee;
Composition
of Scientific
Advisory
Committee
Biosafety [No. 10 of 2007 153
(b) any matter necessary for the effective and transparent
operation of the Scientific Advisory Committee and any
sub-committee;
(c) the terms of reference and competence of the Scientific
Advisory Committee;
(d) the mechanisms and procedures for the appointment of
members and chairpersons of the Scientific Advisory
Committee and any sub-committee;
(e) the manner of appointment of any advisor and the
participation of any advisor in the deliberations and
discussions of the Scientific Advisory Committee or
any sub-committee;
(f) the declaration and manner of dealing with any conflict
of interest among the members or advisors of the
Scientific Advisory Committee or any sub-committee;
(g) the remuneration of the members or advisors of the
Scientific Advisory Committee or any sub-committee;
and
(h) the protection of confidential information for purposes
of this Act by any member or advisor of the Scientific
Advisory Committee or any sub-committee.
9. (1) Any institution that is involved in the import,
development, research, transit, export, handling, contained use,
release or placing on the market of any genetically modified
organism or product of a genetically modified organism shall
establish an institutional biosafety committee to institute and
control safety mechanisms and approval procedures at the
institutional level.
(2) Any institutional biosafety committee established under
subsection (1) shall register with the Authority in such manner
and upon payment of such fee as may be prescribed.
PART III
REGULATION OF ACTIVITIES RELATING TO GENETICALLY MODIFIED
ORGANISMS
10. (1) A person shall not research on, develop, produce,
import, export, transit, carry out any contained use, release or place
on the market any genetically modified organism or any product
of a genetically modified organism or deal in any manner with any
genetically modified organism or a product of a genetically
modified organism without the prior approval of the Authority.
(2) Sub-section (1) applies to any traditional breeding method
which results in or is likely to result in any genetically modified
variety.
(3) Any approval or authorisation of the Authority for any
activity relating to any genetically modified organism or any
product of any genetically modified organism shall be through the
issuance of a permit.
Institutional
biosafety
committees
Prohibition
of import,
export,
transit, etc of
genetically
modified
organism or
product of
genetically
modified
organism
154 No. 10 of 2007] Biosafety
(4) Any person who contravenes subsection (1) commits an
offence and is liable, upon conviction, to a fine not exceeding five
hundred thousand penalty units or to imprisonment for a term not
exceeding ten years or to both.
11. (1) The Authority shall not grant any approval for the
importation, development, production, release into the environment
or placing on the market of any genetically modified organism or
product of a genetically modified organism relating to any crop or
livestock of strategic importance to national food security.
(2) The Minister may, for the purpose of sub-section (1), by
statutory instrument make provision for a list of any strategic crop
or livestock of national importance and food security.
12. A person shall not conduct the following activities:
(a) any gene therapy or somatic gene therapy for improving
or enhancing any desired human characteristic for nonmedical
reasons; and
(b) use of any genetically modified organism or a product
of a genetically modified organism that does not accord
with the public interest, morality or cultural and ethical
values of the people of Zambia.
13. (1) Any person who intends to conduct research on,
develop, apply, import, transit, release, place on the market or carry
out any contained use of any genetically modified organism or
product of any genetically modified organism shall submit an
application in writing to the Authority for authorisation.
(2) The application referred to under sub-section (1) shall
include the following information:
(a) the information set out in the Second Schedule, Third
Schedule and any other information as may be
prescribed under this Act;
(b) an assessment report on risks that may be posed by the
genetically modified organism or product of a
genetically modified organism upon the environment,
biological diversity or human health, non-genetically
modified crop including the consequences of any
unintentional release;
(c) any information from any previous or current release
of the genetically modified organism or product of a
genetically modified organism in the country or in any
other country;
(d) information on any previous approvals or rejections of
the genetically modified organism or any product of
the genetically modified organism by any other country;
No permit on
crop or live
livestock
of strategic
importance
Prohibition
of certain
work on
genetically
modified
organisms
Notification
procedure
Biosafety [No. 10 of 2007 155
(e) if the request for approval is for the purposes of research
and development, the recommendations of the relevant
institutional biosafety committee;
(f) a clear and sequential description of the steps to be
taken in the implementation of the project, and the
monitoring and evaluation that will be made at the end
of each step and the method of disposing off any waste;
(g) the place where and the purpose for which the
genetically modified organism or the product of a
genetically modified organism is planned to be
developed, used, kept, released or marketed, including
detailed instructions for the use and a proposed labelling
and packaging scheme in accordance with the
provisions of this Act;
(h) a declaration confirming that the information provided
is correct including, where appropriate, an undertaking
from the originator of such information affirming its
accuracy and completeness; and
(i) a clear environmental monitoring plan.
14. (1) The Authority shall consult the public prior to the grant
of any authorisation under this Part, in such manner and within
such period as may be prescribed.
(2) The Authority shall for purposes of this Part, consult with
any relevant institution responsible for the conservation,
management or protection of the environment, human and animal
health, and farming local communities.
(3) The Authority shall, upon receipt of an application and
the information referred to in section thirteen, avail the information
to the public and any relevant government institution.
(4) The public shall make comments on the application in
the manner and within such period as may be prescribed.
(5) The Authority shall, in making or reviewing its decision
regarding any application, take into account the views or concerns
of the public, any relevant institution or other stakeholder made in
accordance with the provisions of this Act.
(6) The Authority shall inform the public on the following
matters:
(a) information on any genetically modified organism or
any product of a genetically modified organism which
has been granted or denied authorization for import,
transit, release, including the location of the release,
placing on the market or contained use;
Public
consultation,
information
and
participation
30
35
40
156 No. 10 of 2007] Biosafety
(b) any risk assessment report relating to a genetically
modified organism or product of a genetically modified
organism; and
(c) any report on the evaluation of the risk assessment.
15. The Minister may, by statutory instrument, in consultation
with the Authority, make regulations providing for—
(a) the procedure and manner of consulting or making
information available to the members of the public for
purposes of this Act;
(b) the procedure and manner of submission of any
comments or objections by members of the public under
this Act;
(c) the conduct of public hearings pursuant to this section;
(d) the forms and procedure to be used for purposes of this
section;
(e) the period within which the public may make
submissions to the Authority and decisions made relating
to any application; and
(f) any other matter to give effect to the provisions of this
section for purposes of this Act.
16. (1) The Authority shall, within such period as may be
prescribed, inform the applicant in writing and the public of its
decision.
(2) The Authority may approve or reject the application or
approve the application on such terms and conditions as it may
determine.
(3) The Authority may, prior to making a decision in relation
to any application under this Part, request the applicant to submit
further and additional information as the Authority may consider
necessary for purposes of this Act.
(4) The Authority shall, where an applicant fails to submit
any further or additional information requested under subsection
(3), reject the application.
(5) The Authority shall, where it rejects an application give
reasons to the applicant for the rejection.
17. (1) An approval for a permit shall require the holder to
carry out the activity in a step-by-step sequence and to conduct an
assessment of risks at each step.
(2) Any approval for the import, transit, placing on the market,
release or contained use of a genetically modified organism or
product of a genetically modified organism shall require the permit
holder to carry out monitoring and evaluation of risks on a
continuous basis for a period commensurate with the life cycle of
the species as the Authority may determine.
Regulatory
powers on
public
information,
consultation
and
participation
Decisionmaking
procedure
Permit
condition
Biosafety [No. 10 of 2007 157
(3) A permit holder shall, where any new information becomes
available on any potential risks to human or animal health,
biological diversity or the environment, notify the Authority within
forty eight hours from the time the information becomes available.
(4) A permit issued under this Part shall be used solely by the
person to whom it is issued and is not transferable to any other
person.
18. (1) No approval shall be given unless there is firm and
sufficient evidence that the genetically modified organism or
product of a genetically modified organism poses minimum risk
to human and animal health, non-genetically modified crop,
biological diversity or the environment.
(2) The Authority shall not give any approval for a permit
where there is reason to believe that any harm or damage may be
caused to human and animal health, non-genetically modified crop,
biological diversity or the environment although there is lack of
scientific evidence or certainty.
(3) Lack of scientific evidence shall not be used as a basis for
not taking preventive measures where there is reason to suspect
threats of any damage to socio-economic conditions, human and
animal health, non-genetically modified crop, biological diversity
or the environment.
(4) The Authority may reject an application under this Part
on grounds of public interest.
(5) The Authority shall not grant any approval for a permit
if—
(a) the applicant fails to meet any condition precedent to the
issue of the permit;
(b) the applicant fails to submit the assessment results of the
effect of the use of any genetically modified organism
or product of a genetically modified organism on human
and animal health, non-genetically modified crop,
biologicaldiversity or the environment;
(c) any permit previously held by the applicant has been
revoked by the Authority;
(d) the applicant has been convicted of an offence under this
Act;
(e) the Authority is satisfied that in the interest of protecting
human and animal health, non-genetically modified
crop, biological diversity and the environment, the
permit should not be issued; and
(f)the applicant has been convicted of an offence relating to
biosafety in another country or the applicant’s permit
was withdrawn by the relevant authority in that country.
Criteria for
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making
158 No. 10 of 2007] Biosafety
(6) The Authority shall notify the applicant in writing of the
refusal to issue the permit and shall state the reasons for the refusal.
19. (1) The Authority shall not grant any approval unless it
considers that the import, transit, contained use, development,
release or placing on the market of the genetically modified
organism or the product of a genetically modified organism shall—
(a) benefit the country without causing any risk to human
and animal health, non-genetically modified crop,
biological diversity or the environment;
(b) contribute to sustainable development;
(c) not have adverse socio-economic impacts; and
(d) accord with the ethical values and concerns of
communities and does not undermine community
knowledge and technologies.
(2) The Authority shall, as a condition for approval, require
an applicant to furnish evidence of insurance cover or other
sufficient arrangement to meet its obligations under this Act.
20. (1) An applicant may, where the Authority refuses to grant
a permit, not later than thirty days from the date of receipt of the
notice of refusal, appeal in writing to the Tribunal against the
refusal.
(2) The Minister shall appoint a Tribunal in accordance with
Part XIV of this Act.
21. (1) The Authority may revoke a permit or subject it to
conditions additional to those initially imposed where—
(a) the Authority is satisfied that the holder of the permit has
failed to comply with any conditions relating to the
permit; or
(b) in the opinion of the Authority, new information or a
review of existing information about a genetically
modified organism or any product of a genetically
modified organism has established or is likely to
establish any risk to human or animal health, nongenetically
modified crop, biological diversity or the
environment.
(2) The Authority shall, where it revokes a permit, notify the
permit holder of the decision in writing within seven days of the
revocation and shall state the reasons for the revocation.
(3) The Authority may, where it revokes a permit in accordance
with sub-section (1), order the destruction of the genetically
modified organism or product of a genetically modified organism
or order compensation for the harm caused to human and animal
health, non-genetically modified crop, biological diversity or the
environment.
Socioeconomic
considerations
Appeal
against
refusal to
grant
permit
Revocation of
permit
40
Biosafety [No. 10 of 2007 159
(4) The Authority shall, where the genetically modified
organism or product of a genetically modified organism is a plant
or seed, cause the sterilisation or decontamination of the soil, as
the case may be.
22. (1) A permit holder may, where the Authority revokes
the permit, not later than thirty days from the date of receipt of the
notice of revocation, appeal in writing to the Tribunal against the
revocation.
(2) The decision of the Tribunal on any appeal under this
section shall be subject to further appeal to the High Court.
23. (1) The Authority may suspend, for any period, or cancel
any permit issued under this Act, if in the opinion of the Authority,
any genetically modified organism or product of a genetically
modified organism to which the permit relates poses any risk to
human or animal health, non-genetically modified crop, biological
diversity or the environment.
(2) Upon the suspension of any permit under subsection (1),
the Authority shall notify the holder, in writing, of the period of
the suspension and, during that period, the permit so suspended
shall be of no legal force or effect and shall be surrendered to the
Authority.
(3) Upon the cancellation of any permit under sub-section (1),
the Authority shall notify the holder in writing of such cancellation
and, from the date of the notice, the permit so cancelled shall no
longer be of any legal force or effect and shall forthwith be
surrendered to the Authority.
(4) Upon the suspension or cancellation of any permit under
sub-section (1), the holder may be refunded such proportion of the
fee paid for the permit as the Authority may determine.
(5) Where any person loses a permit, the person shall inform
the Authority within fourteen days of the loss and shall after a
further period of fourteen days apply to the Authority for the
issuance of a duplicate permit.
(6) On application under subsection (5), the Authority—
(a) may issue a duplicate permit on such terms and conditions
as the Authority may determine; or
(b) reject the application and notify the holder in writing
giving reasons for the refusal.
(7) Any person whose permit has been suspended or cancelled
under subsection (1) or to whom the Authority has refused to issue
a duplicate permit under subsection (6) may, not later than thirty
days after the receipt of the notice given under subsection (2) or
(3), or the notice of refusal to issue a duplicate permit under
subsection (5), as the case may be, appeal in writing to the Tribunal
against the suspension, cancellation or refusal.
Appeal
against
revocation
Suspension,
cancellation
and
loss of permit
160 No. 10 of 2007] Biosafety
(8) The decision of the Tribunal on any appeal under this
section shall be subject to further appeal to the High Court.
PART IV
RISK ASSESSMENT
24. (1) An applicant shall carry out or cause to be carried out
an assessment of any risk associated with a genetically modified
organism or a product of a genetically modified organism in respect
of which the application is being made.
(2) The Authority shall not make any decision on any
application to import, transit, make contained use of, develop,
research on, release or place on the market a genetically modified
organism or a product of a genetically modified organism unless
an assessment of risk to human and animal health, non-genetically
modified crop, biological diversity, the environment, socioeconomic
conditions and cultural norms is conducted.
(3) A risk assessment of a genetically modified organism or a
product of a genetically modified organism shall be carried out by
an applicant or the Scientific Advisory Committee, as the case
may be in a scientifically sound manner, on a case by case basis,
in accordance with the Fourth Schedule.
(4) The Authority may require an applicant to bear all the costs
for evaluating a risk assessment report or carrying out the risk
assessment, as the case may be.
(5) The Authority shall reject an application where an
independent risk assessment cannot be undertaken or its
independence verified.
25. (1) The Authority shall evaluate or cause the evaluation of
any risk assessment report and consider the result of the evaluation
in making a decision on any application to import, transit, develop,
research, make contained use of, release or place on the market a
genetically modified organism or a product of a genetically
modified organism.
(2) The Authority shall, where an evaluation of a risk
assessment shows that any risk cannot be avoided, reject the
application for the import, transit, development, research, contained
use of, release or placing on the market of a genetically modified
organism or a product of a genetically modified organism.
Risk
Assessment
Evaluation of
risk
assessment
Biosafety [No. 10 of 2007 161
(3) No person shall be involved in the evaluation of a risk
assessment in respect of a subject matter in which the person has
any direct or indirect interest of any kind, or if, for any reason,
there is, or there is likely to be, a conflict of interest as a result of
the person’s participation in the evaluation process.
(4) A person with a conflict of interest shall declare the fact
and withdraw from the evaluation process.
26. Where the Authority rejects an application under
subsection (2) of section eighteen, any patent or an application for
a patent on the genetically modified organism or product of a
genetically modified organism shall be revoked or rejected by the
relevant authority.
PART V
RISK MANAGEMENT
27. (1) The Authority shall—
(a) develop, maintain and use as the need arises, a risk
management strategy for protecting human and animal
health, non-genetically modified crop, biological
diversity or the environment from accidents in genetic
engineering, the use of any genetically modified
organism or any product of a genetically modified
organism; and
(b) impose such measures as may be necessary to implement
the Fifth Schedule and to avoid adverse effects on the
environment, biological diversity and human and animal
health, including on socio-economic conditions, arising
from a genetically modified organism or a product of a
genetically modified organism.
(2) Without limiting the generality of the foregoing, the
Authority may—
(a) require any genetically modified organism to undergo a
period of observation commensurate with its life cycle
or generation time, at the cost of the applicant, before
and after it is put to its intended use;
(b) prohibit the import, development, research on, transit,
contained use, release or placing on the market of any
genetically modified organism or a product of a
genetically modified organism, if it contains any
characteristic or trait which poses any risk to human
and animal health, non-genetically modified crop, the
environment and biological diversity;
Effect of
refusal of
authorisation
on patents
Risk
management
162 No. 10 of 2007] Biosafety
(c) order the cessation of any activity, which is being
undertaken in violation of any of the provisions of this
Act or any decisions made under it;
(d) order the cessation of any activity involving a genetically
modified organism or a product of a genetically
modified organism that is known to cause risks to human
and animal health, non-genetically modified crop, the
environment or biological diversity;
(e) require the person responsible for any activity under this
Act to take such measures as may be necessary to
prevent or limit any harm to human and animal health,
the environment, non-genetically modified crop,
biological diversity or socio-economic conditions, to
implement remedial measures or restore the
environment to its previous state as far as is feasible;
(f) undertake measures, as necessary, at the cost of the person
responsible, in the event that the person responsible fails
to undertake any safety measures prescribed by the
Authority;
(g) take measures, as necessary, in the case of imminent or
serious danger to human and animal health, the
environment, biological diversity, non-genetically
modified crop, socio-economic conditions or order
public caused by a genetically modified organism or a
product of a genetically modified organism at the cost
of the person responsible for causing the danger;
(h) require an applicant to submit reports periodically in
respect of any monitoring and evaluation of risks carried
out after any approval of the import, research, transit,
development, contained use, release or placing on the
market of a genetically modified organism or a product
of genetically modified organism;
(i)restrict or prohibit the development, research, production,
transit, import, release, contained use or placing on the
market of any genetically modified organism or a
product of a genetically modified organism; and
(j) assess and prohibit the import, transit, research,
development, production, contained use, release or
placing on the market of a genetically modified
organism or a product of a genetically modified
organism that is being or is likely to be used for a hostile
purpose.
Biosafety [No. 10 of 2007 163
(3) The Authority shall, where it has reasonable grounds to
believe that any genetically modified organism or a product of a
genetically modified organism has caused or is likely to cause
serious danger or any adverse effect to human or animal health,
non-genetically modified crop, biological diversity or the
environment, and that immediate action or redress is required, take
such measures as are necessary, without prior notice, to prevent or
limit any harm to human or animal health, non-genetically modified
crop, biological diversity or the environment and all the costs and
expenses for such measures or remedial action shall be borne by,
or be recoverable from, the person responsible for the harm.
PART VI
CO-EXISTENCE
28. (1) A person who cultivates any genetically modified crop
shall prevent any contamination or commingling of the genetically
modified crop with any non-genetically modified crop.
(2) A person who keeps or owns genetically modified livestock
shall prevent any cross -breeding between genetically modified
and non-genetically modified livestock.
(3) Any person who contravenes subsections (1) or (2)
commits an offence and is liable upon conviction to a fine not
exceeding five hundred thousand penalty units or to imprisonment
for a term not exceeding ten years, or to both.
(4) In addition to any penalty that may be imposed under
subsection (3), any person responsible for the contamination or
commingling of genetically modified crop with any non-genetically
modified crop or cross-breeding between genetically modified
livestock with non-genetically modified livestock shall compensate
the person whose crop has been contaminated or livestock crossbred
as the case may be.
(5) The Minister may, by statutory instrument, provide for—
(a) the management measures to ensure non-contamination
of non-genetically modified crops by genetically
modified crops;
(b) the measures to be taken during cultivation, harvesting,
transportation, storage and processing of any genetically
modified crop;
(c) the prevention and management of any accidental mixing
of any genetically modified crop with non-genetically
modified crop;
Co-existence
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practices
164 No. 10 of 2007] Biosafety
(d) the prevention of cross pollination and commingling
between any genetically modified crop and nongenetically
modified crop;
(e) appropriate segregation, certification, identification and
labelling practices and measures;
(f)the restriction of cultivation of a certain type of crop in
any area;
(g) the skill and qualifications of persons involved in the
cultivation, storage, handling, harvesting, transportation
and processing of any genetically modified crop; and
(h) generally, the co-existence of any farming practices and
systems.
(5) The regulations made under subsection (4) may make
provision for measures specific to different types of crop, taking
into account any local or national factors.
(6) Subsections (4) and (5) apply with necessary modifications
to livestock.
PART VII
IDENTIFICATION AND LABELING
29. (1) Any genetically modified organism or product of
a genetically modified organism shall be clearly identified and
labeled as such in accordance with this Act or any regulations
enacted thereunder.
(2) The identification required for purposes of subsection (1)
shall specify the relevant traits and characteristics given in
sufficient detail for purposes of traceability.
(3) Any genetically modified organism or any product of a
genetically modified organism shall be clearly labeled and
packaged in the manner provided for in paragraph C of the Third
Schedule.
(4) The Minister may, in consultation with the Authority, by
statutory instrument, make provision for—
(a) the manner of labeling, identification and packaging of
any genetically modified organism or a product of a
genetically modified organism;
(b) the manner of indicating any genetically modified
organism that may or is likely to cause allergies or pose
any other risk to human or animal health, nongenetically
modified crop, biological diversity or the
environment;
Packaging,
identification
and
labelling
Biosafety [No. 10 of 2007 165
(c) the measures to be taken by a producer, researcher,
importer, exporter or any other person dealing with any
genetically modified organism so as to protect
consumers;
(d) the prevention of fraudulent practices in the packaging,
identification and labeling of any genetically modified
organism or product of a genetically modified organism;
(e) the segregation of genetically modified organisms from
non-genetically modified organisms;
(f)the threshold level for purposes of identification of any
genetically modified organism or a product of a
genetically modified organism; and
(g) any other matter necessary to give effect to the provisions
of this Part.
PART VIII
EXPORT
30. (1) Any person who intends to export a genetically
modified organism or a product of a genetically modified organism
shall provide to the Authority a written advance informed
agreement or approval of the competent authority of the importing
country.
(2) The presentation of the advance informed agreement by
an exporter does not in any manner absolve the exporter from
complying with any other laws governing foreign trade.
(3) There shall be no authorization for the re-export of a
genetically modified organism or product of a genetically modified
organism that is banned by the laws of the exporting country.
(4) An exporter shall —
(a) package any genetically modified organism or a product
of a genetically modified organism in the prescribed
manner so as to prevent any unintentional release in
transit; and
(b) comply with any other requirements imposed by the
competent authority of the importer as to labeling or
other relevant measures to protect human and animal
health, non-genetically modified crops, biological
diversity or the environment from any risk or adverse
effect from any genetically modified organism or a
product of a genetically modified organism.
Procedure
for export
166 No. 10 of 2007] Biosafety
PART IX
REQUIREMENTS FOR GENETICALLY MODIFIED ORGANISMS IN TRANSIT
31. (1) A person shall not make any transboundary movement
of a genetically modified organism or a product of a genetically
modified organism otherwise than with the written consent of the
Authority.
(2) A person shall not transport or transit any genetically
modified organism or a product of any genetically modified
organism through Zambia without authorization from the Authority.
(3) Any person who contravenes this section commits an
offence and is liable, upon conviction, to a fine not exceeding five
hundred thousand penalty units or to imprisonment for a period
not exceeding ten years, or to both.
32. The Minister may, by statutory instrument, in consultation
with the Authority, provide for—
(a) the packaging, handling and transportation of any
genetically modified organism or a product of any
genetically modified organism in transit; and
(b) the conditions to be met and measures to be taken by any
person responsible for the transit of any genetically
modified organism or a product of a genetically
modified organism.
PART X
UNINTENTIONAL RELEASE AND EMERGENCY MEASURES
33. (1) The Authority shall, for purposes of managing any
unintentional release or emergency arising from an accident with
a genetically modified organism or a product of a genetically
modified organism—
(a) require a permit holder to prepare an emergency plan for
the protection of human and animal health, nongenetically
modified crops, biological diversity and the
environment outside the area of release or contained
use in the event of an accident;
(b) require the notification of any hazards in writing by a
permit holder of any appropriate emergency services;
(c) require a permit holder to inform any persons likely to be
affected by the accident on safety measures and
procedures; and
Requirements
for
genetically
modified
organism in
transit
Regulatory
powers
Emergency
response
plan
Biosafety [No. 10 of 2007 167
(d) require the update periodically by a permit holder of any
information relating to safety measures and the making
available of the information to the general public.
(2) A permit holder shall inform the Authority immediately
of any accident and provide the following information:
(a) the circumstances of the accident;
(b) the identity and quantity of any genetically modified
organism released unintentionally;
(c) any measure necessary to assess the effects of any accident
on human and animal health, biological diversity and
in general, the environment; and
(d) the emergency measures taken or to be taken.
(3) The Authority shall, upon receipt of any information under
subsection (2)—
(a) ensure that a permit holder responsible for any accident
takes measures to neutralise risks to human and animal
health, non-genetically modified crop, biological
diversity and the environment; and
(b) inform relevant government and non-governmental
organisations in countries likely to be affected and the
Biosafety Clearing House.
PART XI
CONFIDENTIAL BUSINESS INFORMATION
34. (1) A person shall apply to the Authority in the
prescribed manner upon payment of a prescribed fee, for the
treatment of any information as confidential for business purposes.
(2) The Authority shall, after consultation with the applicant,
determine the information which may be kept confidential and
shall inform the applicant of its decision and the reasons therefor.
(3) The following information shall not be kept confidential:
(a) any description of a genetically modified organism or a
product of a genetically modified organism;
(b) the name, address or other particulars of the applicant;
(c) the purpose and location of the import, transit,
development, research, production, contained use,
release or placing on the market of a genetically
modified organism or a product of a genetically
modified organism;
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business
information
168 No. 10 of 2007] Biosafety
(d) any methods and plans for monitoring of a genetically
modified organism or a product of a genetically
modified organism and for any emergency response;
and
(e) the evaluation of any foreseeable effects, in particular
any pathogenic or ecologically disruptive effects.
(4) A person shall not disclose any confidential information.
(5) Any person who contravenes subsection (4) commits an
offence and is liable, upon conviction to a fine not exceeding two
hundred thousand penalty units or to imprisonment for a term not
exceeding five years, or to both.
(6) The Authority shall not, where an applicant withdraws an
application before approval, disclose any confidential information
relating to the application.
(7) The Authority may, where it determines that it is in the
public interest to do so, make available to the public any
information referred to under section thirteen notwithstanding that
it may be commercially confidential.
35. Notwithstanding subsection (3) of section thirty-four, the
Authority shall, where it is satisfied on the basis of evidence
submitted to it by the applicant and, after consultation with the
applicant, that it is necessary to withhold for a specified time, some
of the information specified in subsection (3) in order to protect
the applicant’s intellectual property rights, withhold that
information to the extent and for so long as it is necessary to protect
the rights.
PART XII
LIABILITY AND REDRESS
36. (1) A person who imports, arranges transit, develops,
makes contained use of, releases or places on the market a
genetically modified organism or product of a genetically modified
organism shall be strictly liable for any harm caused by the
genetically modified organism or product of the genetically
modified organism and shall compensate any person to whom the
harm is caused.
(2) Liability shall attach to the person responsible for the
activity, which results in the damage, injury or loss as well as to
the provider, supplier or developer of the genetically modified
organism or of the product of a genetically modified organism.
Protection of
intellectual
property
rights
Liability and
redress
Biosafety [No. 10 of 2007 169
(3) If there is more than one person responsible for the damage,
injury or loss, then the liability shall be joint and several.
(4) Where any harm is caused to the environment or biological
diversity, compensation shall include the costs of reinstatement,
rehabilitation or clean-up measures which are incurred and where
applicable, the costs of preventive measures.
(5) Liability shall also extend to—
(a) any harm or damage caused directly or indirectly by any
genetically modified organism or a product of a
genetically modified organism to the economy or social
cultural conditions;
(b) any negative impacts on the livelihood or indigenous
knowledge systems or technologies of any community;
(c) any damage or destruction arising from any incidents of
public disorder triggered by any genetically modified
organism or a product of a genetically modified
organism;
(d) any disruption or damage to any production or agricultural
system;
(e) any reduction in yields of the local community;
(f) any soil contamination or damage to biological diversity;
(g) any damage to the economy of an area or community; or
(h) any other consequential disorder.
(6) The right to bring any action in respect of harm caused by
a genetically modified organism or product of a genetically
modified organism shall lapse after a reasonable period from the
date on which the affected person or the community could
reasonably be expected to have learned of the harm, taking due
account of—
(a) the time the harm may take to manifest itself; and
(b) the time that it may take to correlate the harm with the
genetically modified organism or product of a
genetically modified organism, having regard to the
situation or circumstance of the person or community
affected.
(7) Any person, group of persons or any private or state
organisation may bring a claim and seek redress in respect of the
breach or threatened breach of any provision relating to damage
to the environment, non-genetically modified crop, biological
diversity, human and animal health or to socio economic conditions:
170 No. 10 of 2007] Biosafety
(a) in that person’s or group of person’s interest;
(b) in the interest of or on behalf of, a person who is, for
practical reasons, unable to institute such proceedings;
(c) in the interest of, or on behalf of, a group or class of
person whose interests are affected;
(d) in the public interest; and
(e) in the interest of protecting the environment or biological
diversity.
(8) No costs shall be awarded against any of the persons
specified under subsection (7) who fail in any action if the action
was instituted reasonably out of concern for the public interest or
in the interest of protecting human health, biological diversity and
in general, the environment.
(9) Where any harm is caused to human and animal health by
a genetically modified organism or a product of a genetically
modified organism, compensation shall include—
(a) any costs and medical expenses;
(b) compensation for any disability suffered; and
(c) compensation for loss of life.
PART XIII
INSPECTORATE
37. (1) The Authority shall appoint such number of competent
persons to exercise and perform the powers and functions of
inspector as it may consider necessary.
(2) The Authority shall provide an inspector with an
identification card that shall be prima facie evidence of the
inspector’s appointment as such.
(3) An inspector shall, at the request of any person affected
by the exercise, or the performance by an inspector, of any power
or function under this Act, produce for inspection by the person
the identification card referred to under subsection (2).
38. (1) Subject to subsection (2), an inspector may seize and
destroy, without compensation, any genetically modified organism
or a product of a genetically modified organism that—
(a) is not accompanied at the time of importation, transit,
exportation, release, placing on the market or otherwise,
by a permit or other prescribed document;
Appointment
of
inspectors
Seizure,
disposal and
destruction
of genetically
modified
organism or
product illegally
imported,
exported, etc.
Biosafety [No. 10 of 2007 171
(b) is accompanied by a permit that is incorrect in a material
particular;
(c) is imported, in transit, exported, released, placed on the
market or otherwise dealt with contrary to the conditions
of a permit issued in terms of this Act; and
(d) is imported, exported, in transit, released, placed on the
market or otherwise dealt with, in contravention of the
provisions of this Act.
(2) An inspector shall not seize or destroy any genetically
modified organism or a product of a genetically modified organism
unlawfully imported, in transit or exported unless the inspector
gives notice to the importer or exporter of the seizure or destruction
of the genetically modified organism or product of a genetically
modified organism and the reasons therefor.
(3) An inspector shall, where the inspector has reasonable
grounds to believe that any seized genetically modified organism
or product of a genetically modified organism presents a risk to
human and animal health, non-genetically modified crop, biological
diversity or the environment, order the importer, exporter or person
having any custody or control of the genetically modified organism
or product to destroy the goods at the importer’s, exporter’s or
person’s cost.
39. The Authority may, where, after its entry into Zambia,
any genetically modified organism or product of a genetically
modified organism is not claimed or abandoned at a port of entry
within a period of fourteen days from the date of entry into Zambia,
dispose of it by sale or destroy it.
40. (1) The costs and responsibility for the destruction, reexportation,
remediation, sterilization, disposal or any action taken
under this Act shall be borne by the person responsible for the
harm or damage or person who is in contravention of the provisions
of this Act or conditions and terms of a permit, except where the
Authority determines that it should take responsibility for the
associated costs.
(2) Where the person responsible for any harm or damage or
in contravention of the provisions of this Act or the terms and
conditions of a permit does not pay for any cost or fee for
inspection, disposal, remediation or other measure required under
this Act, the genetically modified organism or product of a
genetically modified organism shall be forfeited to the Authority
and disposed of as the Authority may determine.
Disposal of
abandoned
consignment
Costs for
sterilisation,
removal,
destruction,
etc
172 No. 10 of 2007] Biosafety
(3) The assumption by the Authority of any financial
responsibility under sub-section (1) is without prejudice to its
recovering the costs as a debt.
(4) The costs charged for purposes of this section shall be
done in the prescribed manner.
(5) The Authority shall not bear any liability for the destruction
or disposal of any genetically modified organism or product of a
genetically modified organism dealt with in contravention of this
Act.
41. (1) An inspector may—
(a) with a warrant, at any reasonable time, enter upon and
inspect any land, building or premises on or in which
the inspector has reasonable grounds to believe that a
genetically modified organism or product of a
genetically modified organism likely to cause any harm
to human and animal health, non-genetically modified
crop, biological diversity or the environment may be
found or in which an activity is being carried out
contrary to the provisions of this Act;
(b) inspect any operation or process undertaken or carried
out on any land, building or premises in connection with
matters provided for in this Act;
(c) inspect and take any sample of any plant under cultivation,
in storage or in transit, for the purpose of detecting any
genetically modified organism or product of a
genetically modified organism likely to pose any risk
to human and animal health, non-genetically modified
crop, biological diversity or the environment or
cultivated, stored or carried in contravention of the
provisions of this Act;
(d) open and examine any container, conveyance, package
or wrapping reasonably suspected to contain a
genetically modified organism or product of a
genetically modified organism likely to pose any risk
to human and animal health, non-genetically modified
crop, biological diversity or the environment or carried,
stored, kept or packaged in contravention of this Act;
(e) in collaboration with the relevant government agencies,
inspect any consignment of plants, plant products or
regulated articles destined for import into or export from
Zambia to determine whether the consignment is in
compliance with the provisions of this Act;
Powers of
inspectors
Biosafety [No. 10 of 2007 173
(f)inspect and examine any vehicle, carriage or other
conveyance in or upon which the inspector has
reasonable grounds to believe a genetically modified
organism or a product of a genetically modified
organism is being or has been transported;
(g) with warrant, search any person whom the inspector has
reasonable grounds to believe is harbouring any
genetically modified organism or carrying out activities
contrary to this Act;
(h) order the application of measures which are reasonably
necessary or prescribed for purposes of this Act within
a specified period;
(i) order the destruction at any time of any genetically
modified crop which is growing on land or used contrary
to the provisions of this Act;
(j) order the cessation of any activity or operation carried out
in contravention of this Act, any permit condition or
any regulations;
(k) order the adoption of measures prescribed for the purpose
of protecting human and animal health, non-genetically
modified crop, biological diversity or the environment
from any risk posed by a genetically modified organism
or product of a genetically modified organism; and
(l)restrict areas in which any genetically modified crop may
be cultivated.
(2) An owner or occupier of any land, building or premises or
conveyance and the owner’s servants and agents shall afford an
inspector access thereto and shall give such information and provide
such reasonable assistance as the inspector may require for the
purposes of carrying out an inspection.
(3) An inspector may, in the performance of any functions
under this section, be accompanied and assisted by a police officer,
wildlife officer, forestry officer, fisheries or other relevant officer.
(4) Subject to subsection (5), an inspector may, in the course
of an inspection carried out under this section—
(a) seize, destroy, detain, treat or otherwise dispose of any
plant, plant product, material, substance, appliance,
equipment or document, or order that any such action
be taken, at the expense of the owner;
(b) obtain any sample of any plant, substance or product as
the inspector considers necessary; and
174 No. 10 of 2007] Biosafety
(c) order an owner, occupier, person in charge or control to
produce for inspection, or for purposes of obtaining
extracts or copies, any book, document or other
information concerning any matter relevant to the
administration of this Act.
(5) An inspector shall not detain, treat, dispose of or destroy
anything in exercise of powers under this Act unless the inspector,
as soon as is practicable, notifies in writing, the Authority and the
owner or person in possession of the genetically modified organism,
plant, plant product, substance, material or other article of the steps
required or taken and the reasons therefor.
(6) The Authority may following a notice issued by an
inspector under subsection (5) authorise the inspector to detain,
treat, dispose off or destroy the genetically modified organism,
plant, plant product, substance, material or other article as the case
may be under such conditions as the Authority may determine.
42. (1) A person commits an offence if the person—
(a) wilfully delays or obstructs an inspector in the carrying
out of duties or functions under this Act; or
(b) knowingly or negligently gives an inspector false or
misleading information orally, in writing or otherwise.
(2) Any person convicted of an offence under subsection (1)
shall be liable, upon conviction, to a fine not exceeding twenty
thousand five hundred penalty units or to imprisonment for a term
not exceeding five years or to both.
43. (1) Subject to subsection (2), any person aggrieved with
any decision made by an inspector in terms of this Act may, within
seven days of the date of the decision, lodge with the Minister a
notice of that person’s intention to appeal against the order.
(2) There shall be no right of appeal against—
(a) an order for the destruction of a genetically modified
organism or product of a genetically modified organism
likely to pose any risk to human and animal health, nongenetically
modified crop, biological diversity or the
environment; or
(b) an order of destruction of any crop grown on land contrary
to the provisions of this Act or any other law.
(3) A notice of intention to appeal lodged in terms of subsection
(1) shall be in writing and shall specify in detail the grounds upon
which it is given.
(4) The Minister shall transmit to a tribunal board constituted
under section forty-four a notice lodged in terms of subsection
(1).
Obstruction
of inspector
Appeals
against
orders of
destruction
Biosafety [No. 10 of 2007 175
PART XIV
APPEALS
44. (1) Subject to subsection (2), any person making an
appeal under this Act shall lodge the appeal with the Minister and
the Minister shall for the purpose of hearing and determining an
appeal against any refusal to grant a permit or authorisation, revoke
a permit or authorisation or an order of destruction, appoint a
tribunal consisting of three members of whom—
(a) one member, who shall be the chairperson, shall be a
legal practitioner or magistrate; and
(b) two other members which persons shall be experts with
not less than five years experience and knowledge in
matters relevant to this Act.
(2) The Minister shall not appoint a tribunal unless the
appellant deposits with the Minister such sum as the Minister
considers will be sufficient to pay the costs, including the
allowances payable to the members of the tribunal, likely to be
incurred in connection with the appeal.
(3) The powers, rights and privileges of a tribunal shall be
the same as those conferred upon commissioners by the Inquiries
Act, and the provisions of that Act shall, with the necessary
modifications apply in relation to the hearing and determination
of an appeal by the tribunal in terms of this section and to a person
summoned to give evidence before a tribunal.
(4) The Minister shall, on the determination of an appeal
refund to the appellant the sum deposited by the appellant in terms
of subsection (2) less the amount of the costs, if any, payable by
the appellant in terms of subsection (5).
(5) If an appeal is dismissed, the tribunal may order the
appellant to pay to the Government the costs incurred by the
Government in connection with the appeal.
(6) A member of a tribunal shall be paid out of moneys
appropriated for the purpose by Parliament, such allowances to
meet the reasonable expenses incurred by the member in connection
with an appeal as the Minister may prescribe.
(7) The Minister shall where an appeal is lodged, take all
reasonable steps to stay the destruction, disposal or treatment of
the articles pending a determination of the appeal by the tribunal,
except where in the opinion of the Minister, any delay would create
a risk of harm to the environment, biological diversity, human and
animal health.
(8) The tribunal shall, within fourteen days of determining the
appeal, inform the appellant and the Authority in writing of its
decision and the reasons therefor.
Appeals
tribunal
Cap. 41
176 No. 10 of 2007] Biosafety
(9) A determination by a tribunal under sub-section (2) shall
not prejudice the right of any aggrieved party to seek recourse in a
court of competent jurisdiction within thirty days of the
determination.
PART XV
OFFENCES AND PENALTIES
45. (1) Any person commits an offence who—
(a) researches, develops, imports, releases, places on the
market or makes contained use of any genetically
modified organism or product of a genetically modified
organism without the written approval of the Authority;
(b) violates any conditions attached to the grant of approval
under this Act;
(c) fails to furnish any information as required by the
provisions of this Act;
(d) withholds information that has become available to that
person after the approval of the person’s application,
and that could change the evaluation of the risk posed
by that person’s project;
(e) provides false, misleading or deceptive information under
this Act in order to secure an approval;
(f) does not label, package or identify any genetically
modified organism or a product of a genetically
modified organism in accordance with this Act or with
any conditions imposed under this Act;
(g) labels, packages or identifies any genetically modified
organism or product of a genetically modified organism
in a manner that is false, misleading or deceptive or in
contravention of any regulation made under this Act;
(h) exports a genetically modified organism or a product of a
genetically modified organism without the advance
informed agreement of the importing country;
(i) participates in proceedings related to decision taking in
respect of a subject matter covered by this Act in which
thatperson has direct or indirect interest of any kind;
(j) violates any other provision of this Act or any condition
or requirement imposed under this Act;
(k) fails to declare any conflict of interest arising in the
Authority or Institutional Biosafety committee of which
Offences and
penalties
Biosafety [No. 10 of 2007 177
the person is a member, or in the evaluation of a risk
assessment in which that person is involved and fails
to withdraw from its activities in relation to that case;
and
(l) uses a genetically modified organism or a product of a
genetically modified organism for hostile purposes;
(m) obstructs or fails to assist the Authority or other authorised
officers in the performance of their duties under this
Act; or
(n) fails to inform the Authority of an accident or emergency
involving a genetically modified organism or a product
of a genetically modified organism.
(2) Any person who commits an offence under subsection (1)
is liable, on conviction, to a fine not exceeding five hundred
thousand penalty units or to imprisonment for a term not exceeding
fifteen years, or to both.
(3) The court may, where a person is convicted of an offence
under paragraphs (a), (b), (c) or (d) of subsection (1), prohibit the
person from carrying out any activities permissible under this Act,
connected or related therewith.
(4) Where an offence is committed by a corporation, and the
court is of the view that a custodial sentence ought to be imposed,
every person concerned in the management of the corporation at
the time the offence was committed shall be liable to imprisonment
unless the person shows—
(a) that the offence was committed without the person’s
connivance or consent; and
(b) the person took necessary steps to prevent the offence
from being committed.
PART XVI
Miscellaneous
46. (1) The Minister may, in consultation with the Authority,
by statutory instrument, prescribe all matters which by this Act
are required or permitted to be prescribed, or which are necessary
to be prescribed for carrying out or giving effect to the provisions
of this Act.
(2) Without derogating from the generality of subsection (1),
the Minister may, in regulations, orders or notices made or issued
in terms of this Act, provide for—
Regulations
178 No. 10 of 2007] Biosafety
(a) the form and manner in which applications for registration,
permits, certificates and licences are to be made and
the information to be supplied in connection therewith;
(b) the form of permits or certificates, the conditions to be
contained in permits, certificates and licences and the
periods for which permits and licences shall remain in
force;
(c) the persons by whom, the circumstances in which and the
conditions subject to which permits, certificates and
licences shall be issued;
(d) the circumstances in which and the conditions, including
the payment of a fee, subject to which copies of permits,
certificates and licences may be obtained;
(e) the cancellation, suspension and amendment of permits,
certificates and licences and the surrender or delivery
of permits, certificates and licences for those purposes;
(f)the procedures to be followed by inspectors in the exercise
of their powers under this Act;
(g) conditions for the import, export, development, transit,
carriage, packaging, labeling, release, contained use or
placing on the market of any genetically modified
organism or product of a genetically modified organism;
(h) the ports of entry for the import and export of genetically
modified organisms or products of genetically modified
organisms;
(i)the fees payable and procedure in respect of any
application, appeal, matter or document;
(j)the classification and types of genetically modified
organisms and products of genetically modified
organisms;
(k) the requirements for contained use of genetically modified
organisms and products of genetically modified
organisms;
(l) the requirements for laboratory development of genetically
modified organisms and products of genetically
modified organisms;
(m) the requirements for trial release of genetically modified
organisms and products of genetically modified
organisms;
Biosafety [No. 10 of 2007 179
(n) the requirements for general release and marketing of
genetically modified organisms and products of
genetically modified organisms;
(o) the registration of a place or premises where work on
genetically modified organisms and products of any
genetically modified organism is to be undertaken;
(p) the control measures which shall be complied with or
carried out by a user; and
(q) any other matter necessary for the proper implementation
and to give effect to the provisions of this Act.
(3) The Minister may, on the advice of the Authority, in any
regulation made under this section, prescribe in respect of the
contravention of any provision of the regulations—
(a) for a penalty not exceeding a fine of two hundred thousand
penalty units or a term of imprisonment for a period
not exceeding five years, or to both;
(b) the forfeiture of anything which is the subject matter of
the contravention or with which the offence was
committed or which was used in, or for the purpose of,
in relation to, or in connection with, the commission of
the contravention; and
(c) in the case of a continuing offence, an additional penalty
not exceeding a fine of five thousand penalty units on
each count.
47. (1) Any person who, on the commencement of this
Act, carries out any research, import, release, placing on the market,
transit or contained use of a genetically modified organism or
product of a genetically modified organism, shall within three
months of the coming into force of this Act apply for a permit to
the Authority in the manner prescribed under this Act.
(2) A person who contravenes subsection (1) commits an
offence, and is liable, upon conviction, to a fine not exceeding
five hundred thousand penalty units or to imprisonment for a term
not exceeding five years, or to both.
Transitional
Provisions
180 No. 10 of 2007] Biosafety
FIRST SCHEDULE
(Section 4)
PART I
ADMINISTRATION OF AUTHORITY
1. (1) The Authority shall consist of thirteen part-time
members appointed by the Minister.
(2) The members referred to in subparagraph (1) shall include
the following:
(a) one representative each from the ministries responsible for—
(i) science and technology;
(ii) environment and natural resources;
(iii) agriculture;
(iv) health;
(v) commerce, trade and industry;
(vi) information; and
(vii) justice
(b) one person each from the following groups:
(i) consumers;
(ii) religious;
(iii) farmers; and
(iv) traditional authorities and;
(c) two other persons.
(3) The Chairperson and Vice-Chairperson shall be appointed
by the Minister from amongst the members.
(4) A person shall not be appointed as a member of the
Authority if the person—
(a) is an undischarged bankrupt;
(b) has been convicted of an offence under any law in force
or this Act;
(c) has been convicted of any other offence and sentenced to
a term of imprisonment of not less than six months; or
(d) has any financial, contractual or other interest in any
biotechnology enterprise likely to benefit directly or
indirectly from biotechnology or its products.
2. (1) The seal of the Authority shall be such device as may
be determined by the Authority and shall be kept by the Secretary.
(2) The affixing of the seal shall be authenticated by the
Chairperson or the Vice-Chairperson and the Secretary or one other
person authorised in that behalf by a resolution of the Authority.
Composition
of Authority
Seal of
Authority
Biosafety [No. 10 of 2007 181
(3) Any contract or instrument which, if entered into or executed
by a person not being a body corporate, would not
be required to be under seal, may be entered into or executed
without seal on behalf of the Secretary by the Secretary or any
other person generally or specifically authorised by the Authority
in that behalf.
(4) Any document purporting to be a document under the seal
of the Authority or issued on behalf of the Authority shall be
received in evidence and shall be executed or issued, as the case
may be, without any further proof, unless the contrary is proved.
3. (1) Subject to the other provisions of this Act, a member
of the Authority shall hold office for a period of three years from
the date of appointment and may be re-appointed for a further like
period.
(2) The office of a member becomes vacant—
(a) upon the member’s death;
(b) if the member is adjudged bankrupt;
(c) if the member is absent from three consecutive meetings
of the Authority of which the member has had notice,
without the prior approval of the Authority;
(d) upon the expiry of one month’s notice of the member’s
intention to resign from office, given by the member in
writing to the Authority;
(e) if the member becomes mentally or physically incapable
of performing the duties of a member of the Authority;
(f) if the member is convicted of an offence under this Act;
(g) if the member is convicted of an offence under any other
written law and sentenced therefor to imprisonment for
a term of six months or more; or
(h) if a member acquires any interest in a biotechnology
enterprise or any commercial enterprise likely to benefit
directly from biotechnology or its products.
4. (1) Subject to the other provisions of this Act, the Authority
may regulate its own procedure.
(2) The Authority shall meet for the transaction of business as
often as is necessary or expedient for the conduct of its business at
such places and times as the Authority may determine.
(3) Upon giving notice of not less than fourteen days, a meeting
of the Authority may be called by the Chairperson and shall be
called if not less than one third of the members so request in writing:
Proceedings
of Authority
Tenure of
office of
member and
vacancy
182 No. 10 of 2007] Biosafety
Provided that if the urgency of any particular matter does
not permit the giving of such notice, a special meeting may
be called upon a shorter notice given by three members of
the Authority.
(4) The quorum at any meeting of the Authority shall be five of
the members.
(5) There shall preside at any meeting of the Authority—
(a) the chairperson;
(b) in the absence of the chairperson, the vice-chairperson;
and
(c) in the absence of both the chairperson and the vicechairperson,
such member as the members present may
elect from amongst themselves for the purpose of that
meeting.
(6) A decision of the Authority on any question shall be by a
majority of votes of the members present and voting at the meeting
and, in the event of an equality of votes, the person presiding at
the meeting shall have, in addition to a deliberative vote, a casting
vote.
(7) Where a member is for any reasonable cause unable to attend
any meeting of the Authority, the member may, in writing, nominate
another person from the same
organisation to attend such meeting in that member’s stead and
such person shall be deemed to be a member for the purpose of
such meeting.
(8) The Authority may invite any person whose presence in its
opinion is desirable to attend and to participate in the deliberations
of a meeting of the Authority but such person shall have no vote.
(9) The validity of any proceedings, act or decision of the
Authority shall not be affected by any vacancy in the membership
of the Authority or by any defect in the appointment of any member
or by reason that any person not entitled so to do, took part in the
proceedings.
(10) The Authority shall cause minutes to be kept of the
proceedings of every meeting of the Authority and every meeting
of any committee established by the Authority.
5. (1) The Authority may, for the purpose of performing its
functions under this Act, constitute any committee and may delegate
to any such committee such of its functions as it thinks fit.
Committees
of Authority
Biosafety [No. 10 of 2007 183
(2) The Authority may appoint as members of a committee
constituted under sub-paragraph (1), persons who are or are not
members of the Authority and such persons shall hold office for
such period as the Authority may determine.
6. There shall be paid to members of the Authority or any
committee of the Authority such allowances as the Authority may,
with the approval of the Minister, determine.
7. (1) A person who is present at a meeting of the Authority
or any committee of the Authority and who is directly or indirectly
interested in a matter that is the subject of consideration at the
meeting shall, as soon as is practicable after the commencement
of the meeting, disclose the interest and shall not, unless the
Authority or the committee otherwise directs, take part in any
consideration or discussion of, or vote on, any question relating to
the matter.
(2) A disclosure of interest made under this paragraph shall
be recorded in the minutes of the meeting at which it is made.
8. (1) The Authority shall appoint a suitably qualified and
experienced person as Registrar of the Authority who shall be the
chief executive officer of the Authority and who, subject to the
general or special direction of the Authority, shall be responsible
for the carrying out of the provisions of this Act, and shall be
responsible for the administration of the Act.
(2) The Authority shall, with the approval of the Minister,
determine the terms and conditions of service of the Registrar.
(3) The Registrar shall be an ex-officio member and Secretary
of the Authority.
(4) Where the Registrar is for any reason absent or unable to
perform the functions of office, or where a vacancy occurs in the
office of Registrar, the Authority shall designate a member of staff
to act in that capacity for the duration of the absence until the
Registrar resumes functions of office or until another Registrar is
appointed in terms of sub-paragraph (1), and that person has, while
so acting, such powers and shall perform such duties as may be
delegated or assigned by the Authority.
(5) The Authority may appoint, on such terms and conditions
as the Authority may with the approval of the Minister determine,
such other staff as it considers necessary for the performance of
its functions under this Act.
Allowances
of members
Disclosure of
interest
Registrar
and staff of
Authority
184 No. 10 of 200] Biosafety
9. (1) A person shall not, without the consent in writing given
by or on behalf of the Authority, publish or disclose to any
unauthorized person, otherwise than in the course of duties of that
person, the contents of any document, communication or
information whatsoever, which relates to or which has come to the
knowledge of that person in the course of that person’s duties under
this Act.
(2) Any person who contravenes the provisions of subparagraph
(1) commits an offence and is liable, upon conviction,
to a fine not exceeding ten thousand penalty units or to
imprisonment for a term not exceeding two years, or to both.
(3) If any person, having any information which to the
knowledge of that person has been published or disclosed in
contravention of sub-paragraph (1), unlawfully publishes or
communicates any such information to any other person, the person
commits an offence and is liable, upon conviction, to a fine not
exceeding ten thousand penalty units or to imprisonment for a term
not exceeding two years or to both.
10. No action or other proceeding shall lie or be instituted
against any member of the Authority or a committee of the
Authority, or any member of the staff of the Authority, for or in
respect of any act or thing done or omitted to be done in good faith
in the exercise or performance, or purported exercise or
performance, of any of the powers or functions conferred under
this Act.
PART II
FINANCIAL PROVISIONS
11. (1) The funds of the Authority shall consist of such moneys
as may—
(a) be appropriated by Parliament for the purpose of the
Authority;
(b) be paid to the Authority by way of fees, levy, grants or
donations; and
(c) vest in or accrue to the Authority.
(2) The Authority may—
(a) accept moneys by way of grants or donations from any
source in Zambia and subject to the approval of the
Minister, from any source outside Zambia;
(b) subject to the approval of the Minister, raise by way of
loans or otherwise, such moneys as it may require for
the discharge of its functions; and
Prohibition
of
publication
of, or
disclosure of
information
to
unauthorized
persons
Immunity of
members of
Authority
and staff
Biosafety [No. 10 of 2007 185
(c) in accordance with the regulations made under this Act,
charge and collect fees for services provided by the
Authority.
(3) There shall be paid from the funds of the Authority—
(a) such monies as may be necessary for the performance of
its functions under the Act;
(b) salaries, allowances and loans of the staff of the Authority;
(c) such reasonable travelling, transport and subsistence
allowances for members or the members of any
committee of the Authority when engaged in the
business of the Authority, at such rates as the Minister
may determine; and
(d) any other expenses incurred by the Authority in the
performance of its function.
(4) The Authority may, subject to the approval of the Minister,
invest in such manner as it thinks fit such of its funds as it does not
immediately require for the performance of its functions.
12. The financial year of the Authority shall be the period of
twelve months ending on 31st December, in each year.
13. The Authority shall cause to be kept proper books of
accounts and other records relating to its accounts.
14. (1) As soon as practicable, but not later than six months
after the expiry of each financial year, the Authority shall submit
to the Minister a report concerning its activities during the financial
year.
(2) The report referred to in sub-paragraph (1) shall include
information on the financial affairs of the Authority and there shall
be appended thereto—
(a) an audited balance sheet;
(b) an audited statement of income and expenditure; and
(c) such other information as the Minister may require.
(3) The Minister shall, not later than thirty days after the first
sitting of the National Assembly next after the receipt of the report
Financial
year
Accounts
Annual
report
186 No. 10 of 2007] Biosafety
referred to in sub-paragraph (1), lay it before the National
Assembly.
SECOND SCHEDULE
(Section 13)
INFORMATION REQUIRED FOR THE APPLICATION
I General Information
A. Name and address of the applicant
B. Information on personnel and training
1. Name of person(s) responsible for the planning and
carrying out the release, including those responsible for
supervision, monitoring and safety, in particular, name and
qualification(s) of the responsible scientist.
2. Information on training and qualification(s) of personnel
involved in carrying out the release.
II. Information Relating to the Genetically Modified
Organism(s) or Products thereof
A Characteristics of –
(a) the donor;
(b) the recipient; or
(c) (where appropriate) parental organism(s)
1. Scientific name.
2. Taxonomy.
3. Other names (usual name, strain name, cultivars name,
local name etc.).
4. Phenotypic and genetic markers.
5. Degree of relatedness between donor and recipient or
parental organisms.
6. Description of identification and detection techniques.
7. Sensitivity, reliability (in quantitative terms) and specificity
of detection and identification techniques.
8. Description of the geographic distribution and of the natural
habitat of the organisms including information on natural
predators, preys, parasites and competitors, symbionts and
hosts.
9. Potential for genetic transfer and exchange with other
organisms.
10. Verification of the genetic stability of the organisms and
factors affecting it, taking into account the relevance of
the laboratory experiments undertaken for the authentic
Biosafety [No. 10 of 2007 187
ecological conditions under which the organisms live or
are used.
11. Pathological, ecological and physiological traits:
(a) classification of hazard according to existing
national rules concerning the protection of human
and animal health and/or the environment;
(b) generation time in natural ecosystem, sexual and
asexual reproductive cycle;
(c) information on survival, including seasonability and
the ability to form survival structures e.g.: seeds,
spores or sclerotia;
(d) pathogenicity: infectivity, toxigenicity, virulence,
allergenicity, carrier (vector) of pathogen, possible
vectors, host range including non-target
organisms. Possible activation of latent viruses
(proviruses). Ability to colonize other organisms;
(e) antibiotic resistance, and potential use of these
antibiotics in humans and domestic organisms for
therapy and prophylaxis;
(f) involvement in environmental processes: primary
production, nutrient turnover, decomposition of
organic matter, respiration, etc.
12. Nature of indigenous vectors:
(a) Sequence;
(b) Frequency of mobilisation;
(c) Specificity;
(d) Presence of genes, which confer resistance.
13. History of previous modifications.
B. Characteristics of the Vector
1. Nature and source of the vector.
2. Sequence of transposons, vectors and other non-coding
genetic segments used to construct the genetically modified
organism (s) and products thereof and to make the
introduced vector and insert function in the genetically
modified organism (s) and products thereof.
3. Frequency of mobilisation of inserted vector and/or genetic
transfer capabilities and methods of determination.
4. Information on the degree to which the vector is limited
to the DNA required to perform the intended function.
188 No. 10 of 2007] Biosafety
5. Factors (chemical, biological, climatic, etc.) influencing
the functional level of the promoter / enhancer, and how
the functional level is changed.
C. Characteristics of the genetically modified organism (s) and
Products thereof
1. Information relating to the genetic modification:
(a) method used for the modification;
(b) methods used to construct and introduce the insert(s)
into the recipient or to delete a sequence;
(c) description of the insert and / or vector construction;
(d) purity of the insert from any unknown sequence and
information on the degree to which the inserted
sequence is limited to the DNA required to
perform the intended function;
(e) number of intact and truncated vector inserts.
Sequence, functions identity and location of the
altered /inserted/deleted nucleic acid segment(s)
in question with particular reference to any known
sequence; and
(f) sequence and methylation pattern of the recipient
DNA as far as 100 kbp up and down stream from
all DNA inserts.
2. Information on the final genetically modified organism
(s) and products thereof:
(a) description of the genetic trait(s) of phenotypic
characteristics and in particular any new traits and
characteristics which may be expressed or no
longer expressed;
(b) structure and amount of any vector and / or donor
nucleic acid remaining in the final construction
of the genetically modified organism (s) and
products thereof;
(c) stability of the organism in terms of genetic traits;
(d) rate and level of expression of the new genetic
material.Methods and sensitivity of measurement;
(e) activity of the expressed protein(s);
(f) expression levels for the recipient’s genes situated
as far as 100 kbp up and down stream from all
DNA inserts;
Biosafety [No. 10 of 2007 189
(g) sensitivity, reliability (in quantitative terms) and
specificity of detection and identification
techniques;
(h) history of previous releases or uses of the genetically
modified organism (s) or products thereof;
(i) health considerations:
(i) toxic or allergenic effects of the viable or
non-viable genetically modified organism
(s) or product thereof or their metabolic
products;
(ii) product hazards;
(iii) comparison of the genetically modified
organism (s) or products thereof to the
donor, recipient or (where appropriate)
parental organism regarding
pathogenicity;
(iv) capacity for colonisation;
(v) if the organisms is pathogenic to humans
who are immuno competent:
(a) disease caused and mechanism of
pathogenicity including
invasiveness and virulence;
(b) communicability;
(c) infective dose;
(d) host range, possibility of alteration;
(e) possibility of survival outside
human;
(f) presence of vectors or means of
dissemination;
(g) biological stability;
(h) antibiotic resistance patterns;
(i) allergeneicity;
(j) availability of appropriate therapies.
III Information Relating to the conditions of release and the
receiving Environment.
A. Information on the Release
1. Description of the proposed deliberate release, including
the purpose(s) and foreseen products;
2. Foreseen dates of the release and time planning of the
experiment including frequency and duration of releases;
3. Preparation of site prior to the release;
190 No. 10 of 2007] Biosafety
4. Size of the site;
5. Method(s) to be used for the release;
6. Quantities of genetically modified organism (s) or products
thereof to be released;
7. Disturbance on the site (type and method of cultivation,
mining, irrigation or other activities);
8. Workers protection measures taken during the release;
9. Post-release treatment of the site;
10.Techniques foreseen for elimination or inactivation of the
genetically modified organism (s) or products thereof at
the end of the experiment;
11.Information on, and results of, previous releases of the
genetically modified organism (s) or products thereof,
especially at different scales and in different ecosystems.
B. Information of the environment (both on site and in the wider
environment)
1. Geographical location and grid reference of the site(s) (in
case of notification the site(s) of release will be the
foreseen areas of use of the product).
2. Physical and biological proximity to humans and other
significant biota.
3. Proximity to significant biotopes or protected areas.
4. Size of local population.
5. Economic activities of local populations which are based
on the natural resources of the area.
6. Distance to closest areas protected for drinking water and/
or environmental purposes.
7. Climatic characteristics of the region(s) likely to be
affected.
8. Geographical, geological and pedological characteristics.
9. Flora and fauna, including crops, livestock and migratory
species.
10. Description of target and non-target ecosystems likely to
be affected.
11. A comparison of the natural habitat of the recipient
organism with the proposed site(s) of release.
12. Any known planned developments or changes in land
use in the region, which could influence the environmental
impact of the release.
Biosafety [No. 10 of 2007 191
IV Information relating to the interactions between the
genetically modified Organism(s) or Products thereof and the
Environment
A. Characteristics and factors affecting survival, multi-plication,
gene expression and dissemination
1. Biological features which affect survival, multiplication
and dispersal.
2. Known or predicted environmental conditions which may
affect survival, multiplication and dissemination (wind,
water, soil, temperature, pH, pollutants such as pesticides,
heavy metals and others, etc.).
3. Sensitivity to specific agents.
B. Interactions with the Environment
1. Predicted habitat of the genetically modified organism (s)
or products thereof.
2. Studies of the behaviour and characteristics of the
genetically modified organism (s) or products thereof and
their ecological impact carried out in simulated natural
environments, such as microorganisms, growth rooms,
green houses.
3. Genetic transfer capability:
(a) post-release transfer of genetic material from
genetically modified organism (s) or products
thereof into organisms in affected ecosystems;
(b) post-release transfer of genetic material from
indigenous organisms to the genetically modified
organism (s) or products thereof;
4. Likelihood of post-release selection leading to the
expression of unexpected and/or undesirable traits in the
genetically modified organism (s) or products thereof.
5. Measures employed to ensure and verify genetic stability.
Description of genetic traits, which may prevent or
minimise dispersal or genetic material. Methods to verify
stability.
6. Routes of biological dispersal, known or potential modes
of interaction with the disseminating agent, including
inhalation, ingestion, surface contact, burrowing, etc.
7. Description of ecosystems to which the genetically
modified organism (s) or products thereof could be
disseminated.
C. Potential Environmental Impact
192 No. 10 of 2007] Biosafety
1. Potentials for excessive population increase in the
environment.
2. Competitive advantage of the genetically modified
organism (s) or products thereof in relation to the
unmodified recipient or parental organism(s).
3. Identification and description of the target organisms.
4. Anticipated mechanism and result of interaction between
the released genetically modified organism (s) or products
thereof and the target organism.
5. Identification and description on non-target organisms,
which may be affected unwittingly.
6. Likelihood of post release shifts in biological, or in host
range.
7. Known or predicted effects on non-target organisms in
the environment, impact on population levels of
competitors, preys, hosts, symbionts, predators, parasites
and pathogens.
8. Known or predicted involvement in biogeochemical
processes.
9. Other potentially significant interactions with the
environment.
V. Information on monitoring, control, waste treatment and
emergency respose plans
A. Monitoring Techniques
1. Methods for tracing the genetically modified organism (s)
or products thereof, and for monitoring their effects.
2. Specificity (to identify the genetically modified organism
(s) or products thereof, and to distinguish them from the
donor, recipient or, where appropriate, the parental
organisms), sensitivity and reliability of the monitoring
techniques.
3. Techniques for detecting transfer of the donated genetic
material to other organisms.
4. Methods to detect aberrant gene expression.
B. Control of the Release
1. Methods and procedures to avoid and/or minimise the
spread of the genetically modified organism (s) or products
thereof beyond the site of release or the designated area
for use.
2. Methods and procedures to protect the site from intrusion
by unauthorised individuals.
3. Methods and procedures to prevent other
Biosafety [No. 10 of 2007 193
organisms from entering the site.
C. Waste Treatment
1. Type of waste generated;
2. Expected amount of waste;
3. Possible risks;
4 Description of treatment envisaged.
D. Emergency Response Plan
1. Methods and procedures for controlling the genetically
modified organism (s) or products thereof in case of
unexpected spread.
2. Methods for decontamination of the areas affected, e.g.
eradication of the genetically modified organism (s) or
products thereof.
3. Methods for disposal or sanitation of plants, animals, soils,
etc. that was exposed during or after the spread.
4. Methods for the isolation of the area affected by the spread.
5. Plans for protecting human health and the environment in
case of the occurrence of an undesirable effect.
THIRD SCHEDULE
(Section 29)
ADDITIONAL INFORMATION REQUIRED IN THE CASE OF NOTIFICATION FOR
PLACING ON THE MARKET
A. The following information shall be provided in the notification
for placing on the market products, in addition to that of Annex I:
1. Name of the product and name(s) of genetically modified
organism (s) contained therein.
2. Name of the manufacturer or distributor and his address,
including address in the country;
3. Specificity of the product, exact conditions of use
including, when appropriate, the type of environment and/
or the geographical areas(s) of the country for which the
product is suited.
4. Type of expected use: industry, agriculture and skilled
trades, consumers use by public at large.
B. The following additional information shall be provided when
required/relevant:
1. Measures to take in case of unintended release or misuse.
194 No. 10 of 2007] Biosafety
2. Specific instructions or recommendations for storage and
handling.
3. Estimated production in and/or imports to the country.
4. Proposed packaging. This must be appropriate so as to
avoid unintended release of the genetically modified
organism (s) during storage, or at a later stage proposed
labelling. This must include, at lease in summarised form,
the information referred to in points A.1, A.2, A.3, B.1
and B.2.
C. The following information concerning labelling of products
thereof shall be provided on a label and/or in
accompanying documents:
1. The words “This product contains genetically modified
organism (s)” whenever there is evidence of the presence
of genetically modified organism (s) in the product.
2. The words “This product may contain genetically modified
organism (s)”where the presence of genetically modified
organism (s) in a product cannot be excluded but there is
no evidence of any presence of genetically modified
organism (s).
3. The words “This product may cause [specify the particular
reactions, allergies or other side effects]” where it is known
that a particular reaction, allergy or other side effect may
be caused by the product.
4. Where applicable, further or as a qualification to C.1 or
C.2, the words “This product contains genetic material
(nucleic acids) from genetically modified organism (s)”
or this product is based on raw materials from genetically
modified organism”.
5. The identification and labelling shall specify the relevant
traits and characteristics in sufficient detail for purposes
of traceability and to facilitate verification by both
importing and transiting countries.
FOURTH SCHEDULE
(section 24)
RISK ASSESSMENT
The risk assessment shall take the following parameters into
consideration:
A. General Principles
Biosafety [No. 10 of 2007 195
1. The guiding principle of risk assessment is the
precautionary approach. Where the transboundary
movement, or use or handling of genetically modified
organism(s) or products thereof may cause, or has a proven
or theoretical potential (or based or reasonable scientific
theory of hazards based on deductive, circumstantial as
well as inductive evidence) to cause harm to biodiversity,
ecosystems, human or animal health, the lack of full
scientific certainty or consensus regarding the level of risk
should not be interpreted as the lack of risk, or as
acceptable risk.
2. The risk assessment should take into account, inter alia,
all relevant scientific theory, evidence and experience,
including previous risk assessments. This enables the risk
assessment to evolve in the light of new evidence and
knowledge; a genetically modified organism or product
thereof previously considered acceptable may no longer
be acceptable, and vice versa.
3. It shall be accepted as a principle underlying the risk
assessment that every transgenic line is different because
of random insertion, even if they are made with the same
vector system, the same gene constructs and the same
variety, and that it has to be well characterised to be stable
for at least five generations under a reasonable range of
environmental conditions that it may encounter.
4. The risk assessment should take into account, inter alia:
(a) all relevant scientific theory, evidence and
experience;
(b) The general characteristics of both the genetically
modified organism or product thereof and the
parent organisms, the vector(s) used, the genetic
modifications and the novel trait(s), including
marker traits(s) and other sequences even when
not expressed;
(c) the naive environments or host range of the recipient
organism and donor organisms;
(d) the intended use(s) of the genetically modified
organism or product thereof and the nature of the
receiving and surrounding environments;
(e) potential impact of the genetically modified
organism or product thereof on the environment,
including long-term direct and indirect ecological
impacts, particularly on centres of origin and areas
with high genetic diversity of taxa related to the
genetically modified organism or product thereof;
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(f) effects, long term and direct or indirect, of the
genetically modified organism or product thereof
on human, plant and animal health;
(g) socio-economic impacts;
(h) conformity with ethical norms;
(i) details of risk assessments completed elsewhere.
B. Specific Information Requirements
The information required for risk assessment should include the
following:
1. Characteristics of donor and recipient organisms or parental
organisms:
(a) scientific name and taxonomy;
(b) strain, cultivar or other name;
(c) species it is related to and degree or relatedness;
(d) the degree of relatedness between the donor and recipient
organisms, or between the parental organisms;
(e) all sites from where the donor and recipient organisms or
parental organisms were collected, if known;
(f) information on the type of reproduction (sexual/asexual)
and the length of reproductive cycle or generation time,
as appropriate, as well as the formation of resting and
survival stages;
(g) history of prior genetic manipulation, whether the donor
or recipient organisms are already genetically modified;
(h) phenotypic and genetic markers of interest;
(i) description of identification and detection techniques for
the organisms, and the sensitivities of these techniques;
(j) geographic distribution and natural predators, prey,
parasites, competitors, symbionts and hosts;
(k) climatic characteristics of original habitats;
(l) ability of the organisms to survive and colonise the
environment to which release is intended or otherwise;
(m) genetic stability of the organisms, and factors affecting
the stability;
(n) the presence of endogenous mobile genetic elements of
viruses likely to affect the genetic stability;
(o) the potential of the organisms to transfer or exchange genes
with other organisms, either vertically or horizontally;
(p) pathogenicity to humans or animals, if any;
(q) if pathogenic, their virulence, infectivity, toxicity and
modes of transmission;
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(r) known allergeneicity and/or toxicity of biochemical and
metabolic products;
(s) availability of appropriate therapies for pathogenicity,
allergeneicity and toxicity.
2. Characteristics of the Vector(s):
(a) nature and source of the vector(s);
(b) genetic map of the vector(s), position of the gene(s)
inserted for the transfer, other coding and non
coding sequences affecting the expression of the
introduced gene(s), and marker gene(s);
(c) ability of the vector(s) to mobilise and transfer genes
by integration and methods for determining the
presence of the vector(s);
(d) complete nucleotide sequence of the vector(s);
(e) history of prior genetic manipulation, whether the
donor or recipient organisms are already
genetically modified;
(f) potential for pathogenicity and virulence;
(g) natural and host range of vectors;
(h) natural habitat and geographic distribution of natural
and potential hosts;
(i) potential impacts on human and animal health and
the environment
(j) measures for counteracting adverse impacts;
(k) potential to survive and multiply in the environment,
or to from genetic recombinants; and
(l) genetic stability of vector(s), such as hypermutability.
3. Characteristics of the genetically modified organism or
Product thereof:
(a) the description of the modifications made using gene
technology;
(b) the function of the genetic modifications and/or the
new insert, including any marker gene(s);
(c) purpose of the modification and intended use in
relation to need or benefit;
(d) method of modification and, in case of transgenic
organisms, the methods for constructing inserts
and to introduce them into the recipient organism;
(e) whether introduced gene(s) are integrated or extra
chromosomal;
(f) number of insert(s) and its/their structure(s), for
example, the copy number, the number of
198 No. 10 of 2007] Biosafety
truncated or fragmented inserts, whether in tandem
or other types of repeats and the position of each
insert;
(g) nucleotide sequence of each insert, including at least
100 kbp up and down stream form the insert;
(h) products of the transferred gene(s), levels of
expression and integration;
(i) stability of the introduced gene(s) in terms of
expression and integration;
(j) biochemical and metabolic differences of the
genetically modified organism or product thereof
compared with unmodified organism;
(k) probability of vertical or horizontal gene transfer to
other species;
(l) probability of inserts or transferred gene(s) to
generate pathogenic recombinants with
endogenous viruses, plasmids and bacteria;
(m) allergeneicities, toxicities, pathogenicities and
unintended effects;
(n) autecology of the genetically modified organism or
product thereof compared with that of the
unmodified organism
(o) susceptibility of the genetically modified organism
or product thereof to diseases and pests compared
with the unmodified organism;
(p) detailed information on past used including results
on all experiments leading to previous releases
4. Characteristics of resuscitated organisms and gene(s) and
fossil DNA sequences:
Resuscitated Organism
(a) scientific name and taxonomy;
(b) identify of nearest species and their characteristics
which are of relevance to the intended use;
(c) site at which it was found;
(d) method used for resuscitation;
(e) purpose of introducing the organism and benefits, if
any;
(f) impacts on human and animal health and the
environment;
(g) measures for counteracting adverse impacts;
Biosafety [No. 10 of 2007 199
(h) length of time the organisms has been in use;
(i) genetic stability;
(j) likelihood of gene transfer to other organisms;
(k) fossil and living nearest relative species;
(l) biological and biochemical differences from related
living species;
(m) information on previous uses since resuscitation.
DNA sequences from fossils or from resuscitated organism
(a) scientific name and taxonomy of the species whether
resuscitated or a fossil;
(b) site of origin of the fossil;
(c) site of the gene in the resuscitated genome, if known;
(d) base sequence of the extracted gene;
(e) method used in extracting the gene;
(f) function of gene, if known;
(g) purpose of use and benefits, if any;
(h) environment in which it lived before fossilisation;
(i) fossil species related to the species from which the
gene was taken;
(j) living species related to the species from which the
gene was taken;
5. Safety Considerations for Human and Animal Health:
Information on the genetically modified organism or
product and informationon the donor and recipient
organisms as well as the vector before it was disarmed or
disabled in cases where it has been disarmed or disabled,
regarding:
(a) capacity for colonisation
(b) if the genetically modified organism or product
thereof is pathogenic to humans or animals the
following information is required:
(i) disease caused and mechanisms of
pathogenicity, including invasiveness and
virulence, and property of virulence;
(ii) communicability;
(iii) infective dose;
(iv) host range and possibilities of alteration;
(v) ability to survive outside of the human or
animal host;
200 No. 10 of 2007] Biosafety
(vi) the existence of vectors or other means of
transmission;
(vii) biological stability;
(viii) allergeneicity and
(ix) availability of appropriate therapies.
6. Environmental Considerations:
Information on the genetically modified organism or
product thereof and information on the donor and recipient
organism as well as the vector before it was disarmed or
disabled where it has been disarmed or disabled, regarding:
(a) factors affecting the survival, reproduction and
spread of the genetically modified organism or
product thereof in the environment;
(b) available techniques for detection, identification and
monitoring of the genetically modified organism
or product thereof;
(c) available techniques for detecting transmission of
genes from the genetically modified organism or
product thereof to other organisms;
(d) known and predicated habitats of the genetically
modified organism or product thereof;
(e) description of the ecosystems which could be
affected by accidental release of the genetically
modified organism or product thereof;
(f) possible interaction between the genetically modified
organism or product thereof and other organisms
in the ecosystem which might be affected by
accidental release;
(g) known or predicted effect on plants and animals
such as pathogencity, infectibity, toxicity,
virulence, being a vector of pathogens,
allergeneicity, and colonisation;
(h) possible involvement in biogeochemical processes;
(i) availability of methods for decontamination of the
area in case of accidental releases;
(j) effects of agricultural practices with possible
undesirable impacts on the environment.
7. Socio-economic Considerations:
(a) anticipated changes in the existing social and
economic patterns resulting from the introduction
Biosafety [No. 10 of 2007 201
of the genetically modified organism or product
thereof;
(b) possible threats to biological diversity, traditional
crops or other products and, in particular, farmer’s
varieties and sustainable agriculture;
(c) impacts likely to be posed by the possibility of
substituting traditional crops, products and
indigenous technologies through modern
biotechnology outside of their agro-climatic zones;
(d) anticipated social and economic costs due to loss of
genetic diversity, employment, market
opportunities and, in general, means of livelihood
of the communities likely to be affected by the
introduction of the genetically modified organism
or product thereof;
(e) possible countries and/or communities to be affected
in terms of disruptions to their social and economic
welfare;
(f) possible effects, which are contrary to the social,
cultural, ethical and religious values of
communities arising from the use or release of the
genetically modified organism or product thereof.
FIFTH SCHEDULE
(Section 27)
RISK MANAGEMENT SCHEMES
The user shall employ the following risk management schemes
and procedures from the development, through all stages of testing
of the genetically modified organism or the product of a genetically
modified organism, to its intended use or commercialisation.
1. Imported products of genetically modified organisms used
for human or animal health (for example, antibodies, drugs
and hormones):
(a) observation to ensure that changes in food habits,
nutrition and other factors that could conceivably
modify the expected impacts are insignificant;
(b) such observation can be limited in scope when it is
shown that adequate trials on the specific products
have been made on humans or animals, as
appropriate, in areas other than the State of import.
2. Imported microbial genetically modified organisms for
human and animal health:
202 No. 10 of 2007] Biosafety
Besides the limited observation specified in 1,
experiments shall be carried out to evaluate
viability and risks of reacquiring virulence or
lending virulence to other micro-organisms when
in the body and in the environment, since some
spilling is inevitable.
3. Imported genetically modified organisms for contained use:
(a) the products of genetically modified organisms will
be treated as in 1 above.
(b) experiments will be made in complete laboratory
containment to determine:
(i) longevity of the genetically modified
organism in cases of unintended release
in the premises and in the surrounding
environment; and
(ii) genetic transfer into other micro-organisms
and implications thereof on human and
animal health and the environment; and
(d) methods for counteracting adverse impacts resulting
from unintended releases should be specified.
4. Products of genetically modified organism made locally:
(a) trial on experimental animals will be made when
the product of the genetically modified organisms
is intended to be used on humans;
(b) in all other cases, trials will be made on species for
which the product of the genetically modified
organism has been designed.
5. Genetically modified organisms made locally for
use as human or animal vaccines:
(a) initial molecular, tissue culture, serological and other
related studies in the laboratory in complete
containment;
(b) trials with experimental animals under strict
containment;
(c) experiments in complete containment to evaluate
the extent of transfer of the genes of the vector
introduced or of other genes through the agency
of the vector to the genetically modified organism
or to other species which will be found in
association with the genetically modified organism
to ensure that virulence is not acquired by the
Biosafety [No. 10 of 2007 203
genetically modified organism in question or by
other micro-organisms;
(d) trials on animals completely contained from their
species and from related species and species
known to be susceptible to the gene recipient
micro-organism from which the genetically
modified organism has been made; and
(e) statistically valid trials in conditions in which the
vaccinated individuals live in their communities.
6. Imported plant or microbial genetically modified organism
for release:
(a) the reports from releases in areas other than the State
of Import shall be thoroughly evaluated by the
Authority. Particular emphasis shall be given to
whether the applicable regulations in the previous
release have been adequate to ensure safety;
(b) if the regulations mentioned in (a) have not been
found adequate, the Authority shall decide at
which step in item 8 the observations should begin;
(c) if it is decided that the previous release mechanisms
have been rigorous enough, observations shall be
made in experimental conditions completely
contained from the outside environment, but
otherwise kept at the same soil community,
moisture, air temperature and plant and animal
community conditions as the intended area of
release;
(d) the observations will include the health of the
genetically modified organism, the health of the
organism within the area of limited release, and
the biological diversity and the ecology of the area;
and
(e) nationally approved limited field releases will be
carried out with appropriate emergency
procedures in place to deal with possible cases of
escape.
7. Imported animal genetically modified organism for lease:
(a) the reports from releases in areas other than Zambia
shall be thoroughly evaluated by the Authority.
Particular emphasis shall be given to whether the
204 No. 10 of 2007] Biosafety
applicable regulations in the previous release have
been adequate to ensure safety;
(b) if the regulations mentioned in (a) have not been
found adequate, the Authority shall decide at
which step in item 9 the observations should begin;
(c) if it is decided that the regulations used in the
previous release have been rigorous enough, then
observations will be made in complete
containment in the expected ambient climatic,
nutritional and other environmental conditions to
monitor physiological functions, adaptations and
gene transfers;
(d) when the results have met the stated requirements,
then a trial release may be authorised with
adequate emergency plans put in place to deal with
cases of escape.
8. Plant or microbial genetically modified organisms
produced locally for eventual release:
(a) laboratory biomolecular experiments on
transformation or resuscitation and other
phenomena will be carried out in complete
containment;
(b) tissue culture experiments to develop the genetically
modified organism, when required, will be carried
out in complete containment;
(c) observations aimed at understanding the nature of
the genetically modified organism shall be carried
out in complete containment;
(d) experiments with the soil, soil micro-organisms,
plant and animal species, under the environmental
conditions of the area of intended release, will be
carried out in complete containment;
(e) complete observations of the interactions of the
genetically modified organism with the
environment (soil including micro-organisms and
terrestrial communities) will be made in enclosed
fields but not fully contained. At the end of the
experiment, the products of the genetically
modified micro-organisms may be use on an
experimental basis, otherwise they shall be
destroyed;
(f) the product from the genetically modified organism
shall be subjected to the procedure in 4;
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(g) the monitoring of the spread and behaviour of any
released plant or micro-organism, genetically
modified organism shall continue for at least 150
years in the case of trees, and for at least 30 years
in the case of annuals and micro-organisms, the
duration for perennials which live shorter than
trees being in between. The user who is
responsible for releasing the genetically modified
organisms or its successor shall provide annual
reports to the Authority.
9. Animal genetically modified organism produced locally
for eventual release:
(a) laboratory biomolecular experiments on
transformation (or resuscitation if it is possible)
and other phenomena will be carried out in
complete containment;
(b) methods of incubating the transformed generative
cell or the resuscitated animal will be carried out
in complete containment;
(c) the rearing of and observations on the genetically
modified organism will be carried out under
complete containment;
(d) the genetically modified organism shall be observed
under complete containment in an experimental
environment which simulates the intended area of
release in climatic, microbial, animal and plant
communities. The observations shall include the
condition of the transgenic animal and those of its
micro-organisms especially in the context of gene
transfer and those of the microbial, plant and
animal communities in the experiment, again
including gene transfer;
(e) a limited release will be carried out in an area with
appropriate enclosure and emergency measures put
in place to prevent escape. Observations will
include the condition of the genetically modified
organism, its micro-organism focusing on gene
transfer, and the ecology of the microbial, plant
and animal communities in the area, again
including gene transfer;
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(f) if the animal is intended to yield a product, the
regulation of the product will follow the procedure
in item 4;
(g) the monitoring of the spread and behaviour of any
released animal genetically modified organism
will continue for at least 30 years.
10. General Requirements:
(a) all trials, experiments or observations specified in
all the above cases (1-9) are put in their logical
sequence and shall be subjected to the hierarchical
procedures of approval by the lower institutional
and higher national level bodies, namely the
institutional biosafety committees or the
subcommittees or the Scientific Advisory
Committee and the Authority;
(b) experiments starting from transformation of living
organisms or resuscitation of fossil organisms
carried out under completely contained laboratory
conditions and continuing in the development of
genetically modified organisms or products
thereof shall be subject to approval by the
institutional biosafety committee or by the
Authority as the case may be. All experiments
outside of strict laboratory isolation and initial
experiments involving imported genetically
modified organisms or products thereof shall be
subject to approval by the Authority. All final
approval for the use of genetically modified
organisms or products thereof shall be made by
the Authority;
(c) once approval from the Authority is obtained at the
completion of the final stage of trials, experiments
or observations, the genetically modified organism
in question or the product thereof can be employed
for its intended use. The Authority shall notify its
decision in writing to the competent authority.
(d) whenever there is need to dispose of the genetically
modified organism or the product thereof upon
the completion of every trial or experiment, it shall
be made through complete incineration or other
approved means of complete destruction.
(e) the release of genetically modified organisms or
products thereof shall be monitored appropriately
and emergency plans to prevent escape and
accident shall always be in place.
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