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Policy and Regulation » Africa

Title: Model Law for Safety in Biotechnology for Africa
Publication date: May 01, 2001
Posting date: March 01, 2005

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AFRICAN MODEL LAW ON SAFETY IN BIOTECHNOLOGY
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PREAMBLE

Whereas, modern biotechnology might have much promise for the improvement
of human well-being, its potential adverse effects on human health,
biological diversity and in general the environment are causing a growing
public concern;

Whereas, it is the responsibility of the Government to ensure the safety of
the people and the environment with respect to the risks arising from
genetically modified organisms (GMOs) and products of genetically modified
organisms resulting from modern biotechnology;

Whereas, with the potential risks posed by genetic modification it is
consistent with the precautionary principle to regulate any undertaking for
the import, transit, contained use, release, or placing on the market of
genetically modified organisms and products of genetically modified
organisms;

Whereas, it is important to enhance the capacity which is necessary to cope
with the nature and scale of known and potential risks associated with
genetically modified organisms and products of genetically modified
organisms;

Now, therefore, it is hereby legislated as follows:

ARTICLE 1
DEFINITIONS
For the purposes of this law:

advance informed agreement means consent obtained 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 before any activity is undertaken.

applicant means any natural or legal person who submits an application in
writing to the Competent Authority seeking approval to import, transit,
make contained use of, release or place on the market genetically modified
organisms or products of genetically modified organisms, or where the
context so requires, any person to whom the approval has already been
granted.

cell technology means techniques for the production of living cells with
new combinations of genetic material by the fusion of two or more cells.

contained use means any operation in which genetically modified organisms
are produced, grown, stored, destroyed or used in some other way in a
closed system not exceeding x cm2 in volume in which physical barriers are
employed, either alone or together with chemical and/or biological
barriers, to effectively prevent their contact with, and their impact on,
humans and the external environment.

deliberate release or release means any intentional introduction into
the environment of a genetically modified organism or a product of a
genetically modified organism; this includes releases for: commercial
purposes, aid food, remediation, research purposes in field experiments,
use of genetically modified organisms in greenhouses, aqua-culture
facilities, animal accommodation unless the facility is approved for
contained use, as part of an approved laboratory or other installations,
disposal of waste containing genetically modified organisms, import, export
or transport of genetically modified organisms or products of genetically
modified organisms.

export from a given country means the intentional transboundary movement
from that country to another country.

exporter means any legal or natural person who arranges for a genetically
modified organism or a product of a genetically modified organism to be
exported.

gene technology means any technique that involves the isolation,
characterization, modification or introduction of DNA into living cells or
vectors used for DNA transfer (plasmids, viruses, artificial chromosomes).

genetically modified organism (GMO) means any biological entity, capable
of replication or of transferring genetic material, and includes plants,
animals, micro-organisms (for example, viruses, bacteria, fungi), cell
cultures, all vector systems (plasmids, viruses, artificial chromosomes),
and naked nucleic acids like viroids or DNA sequences in which the genetic
material has been altered through modern biotechnology.

hostile purpose means the development, acquisition, application, or
deliberate release of a genetically modified organism or a product of a
genetically modified organism with the intention of causing harm to human
health, biological diversity, the environment, or property for a purpose
not approved by the Competent Authority.

import into a given country means the intentional transboundary movement
into that country from another country.

importer means any legal or natural person who arranges for a genetically
modified organism or a product of a genetically modified organism to be
imported.

modern biotechnology includes the following techniques:
a) recombinant nucleic acid techniques 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) techniques involving the direct introduction into an organism of
heritable material prepared outside the organism including micro-injection,
macro-injection and micro-encapsulation; and
c) cell fusion (including protoplast fusion) or hybridization techniques
where live cells with new combinations of heritable genetic material are
formed through the fusion of two or more cells .

notification means providing information to, and where appropriate, the
lodging of samples, with the Competent Authority, at the same time as
taking responsibility for the accuracy and completeness of the information.

person includes both natural and legal entities.

placing on the market means supplying or making available to third
parties a genetically modified organism or a product of a genetically
modified organism, whether there has been monetary exchange or not, and
includes the giving as aid food.

product of a genetically modified organism means any material derived by
processing, or howsoever otherwise, from any genetically modified organism
or from a product of a genetically modified organism.

risk assessment means the evaluation of the direct and indirect, short,
medium and long term risk to human health, biological diversity and in
general the environment, including to socio-economic conditions or to
ethical values arising from the import, transit, contained use, release or
placing on the market of a genetically modified organism or of a product of
a genetically modified organism.

socio-economic impact means the direct or indirect effect of a
genetically modified organism, or a product of a genetically modified
organism on the economy or on social or cultural conditions or on the
livelihood or indigenous knowledge systems or technologies of a community
or communities, including on the economy of the country.

use excludes the acquisition from local markets or from nationally
authorized sources, including aid food, by purchase or otherwise, by a
member of the general public and utilisation or dealing thereafter unless
specific conditions have been attached regarding the utilisation.


ARTICLE 2
SCOPE

This law shall apply to the import, export, 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.


ARTICLE 3
INSTITUTIONAL ARRANGEMENTS

1. National Focal Point
The government shall designate or establish a National Focal Point to be
responsible on its own behalf for liaison with the Secretariat of the
Protocol and Clearing-House, and facilitate the exchange of information
among the relevant bodies and authorities.

2. Competent Authority
The Government shall designate or establish a Competent Authority to follow
up, supervise and control the implementation of this law. The powers and
duties of the Competent Authority shall include the following:
(a) to prescribe criteria, standards, guidelines and regulations as may be
necessary for the fulfillment of the objectives of this law;
(b) to take into account the policy recommendations and other guidelines of
the National Biosafety Committee in making decisions on the import,
transit, contained use, release or placing on the market of a genetically
modified organism or a product of a genetically modified organism;
(c) to cause the establishment of Institutional Biosafety Committees at
relevant institutions or nominate independent panels or any other body of
experts, as appropriate, as technical and scientific advisors on issues of
biosafety;
(d) to keep genetically modified organisms and products of genetically
modified organisms globally under constant review and when any one of them
is suspected of posing a serious risk to human health, biological diversity
and in general the environment, to ban its transiting through the country’s
territories and notify the Clearing-House, the customs and trade officials
accordingly;
(e) to inform the Secretariat of the Cartagena Protocol, if appropriate,
that it has no access to the Clearing-House;
(f) to maintain and make available to the public on request, a data base on
genetically modified organisms and products of genetically modified
organisms intended for direct use as food or feed, or for processing;
(g) to declare through the Biosafety Clearing-House that:
i) a genetically modified organism or a product of a genetically modified
organism intended as food or feed or for processing may be imported only
after it has been subjected to a full risk assessment according to this
law; and
ii) it is an application to import that will trigger the risk assessment
and that it shall not automatically happen every time a new genetically
modified organism is posted in the Clearing-House;
(h) to review, make or have made risk assessments of genetically modified
organisms or products of genetically modified organisms. When the
genetically modified organism or the product of a genetically modified
organism is to be imported, the cost will be borne by the exporter;
(i) to take legal measures nationally or internationally to protect human
health, biological diversity and in general the environment from risks that
may be posed by genetically modified organisms or their products, inter
alia, through enforcing this law and the Cartagena Protocol on Biosafety;
(j) to designate inspectors and undertake inspection as well as other
control measures to ensure compliance with this law; and
(k) any other functions as may be specified by the government.

3. National Biosafety Committee
(a) A National Biosafety Committee comprising representatives of
governmental and non-governmental organizations, and the private sector
that are relevant to the issues of biotechnology and biosafety shall be
established by the government to provide, as appropriate, policy
recommendations and guidelines to the Competent Authority.
(b) The National Biosafety Committee shall further develop, based on its
general responsibility specified in 2(a) of this Article, its terms of
reference, and may draw up its own rules of procedure.
(c) A member of a National Biosafety Committee who finds a conflict of
interest in the case at hand shall so declare it and withdraw from the
Committee in so far as that case of conflict of interest is concerned.

4. Institutional Biosafety Committee
Institutions that are involved in the import, transit, export, handling,
contained use, release or placing on the market of genetically modified
organisms or products of genetically modified organisms shall establish
Institutional Biosafety Committees to institute and control safety
mechanisms and approval procedures at the institution level.


ARTICLE 4
APPLICATION

1. No person shall import, transit, carry out the contained use of or
release of, or place on the market, a genetically modified organism or a
product of a genetically modified organism without an advance informed
agreement or the explicit written approval of the Competent Authority,
whichever is appropriate.

2. Any person who wishes to carry out any import, or transit, or deliberate
release, or contained use of, or place on the market, a genetically
modified organism or a product of a genetically modified organism shall
submit an application in writing to the Competent Authority.

3. The application shall include:
(a) the information specified in Annex I and such other information as may
be prescribed by the Competent Authority;
(b) assessment report on risks that may be posed by the genetically
modified organism or product of a genetically modified organism upon human
health, biological diversity and in general the environment, including the
consequences of unintentional release;
(c) information from 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 previous approvals or rejections of the genetically
modified organism, or the product of the genetically modified organism by
any other country;
(e) if the request for approval is for the purposes of research and
development, the recommendations of the 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 of 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 use and a proposed labeling and packaging scheme in
accordance with Annex II, part C of this law; and
(h) the applicant shall submit 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.

4. Any person who wishes to import, transit, or place on the market a
genetically modified organism or a product of a genetically modified
organism intended for direct use as food or feed, or for processing, shall
submit an application in writing with a reference to the information on the
item found in the Clearing-House, to the Competent Authority.


ARTICLE 5
PUBLIC PARTICIPATION

1. The Competent Authority shall, upon receipt of the information referred
to under Article 4.3 and Article 4.4, make available the said information
to the public and relevant government authorities.

2. The public may make comments within such period and in such a manner as
may be specified by the Competent Authority, which should, however, be long
enough for meaningful public reaction.

3. In cases where the Competent Authority arranges for a public
consultation with regard to any proposed import, transit, contained use,
release or placing on the market of a genetically modified organism or a
product of a genetically modified organism, this fact shall be announced in
a media with national coverage and a period of not less than … days shall
pass before the decision is made.
4. The Competent Authority shall, in making or reviewing its decision, take
into account the views and concerns of the public expressed in accordance
with paragraphs (2) and (3) of this Article.

5. The Competent Authority shall make available to the public:
a) information on any genetically modified organism or a product of a
genetically modified organism which has been granted or denied approval for
import, transit, contained use, release or placing on the market; and
b) in particular, any risk assessment report with respect to the
genetically modified organism or the product of a genetically modified
organism.


ARTICLE 6
DECISION MAKING PROCEDURE

1. The Competent Authority of the country shall ensure that the import,
transit, contained use, release or placing on the market of a genetically
modified organism or the product of a genetically modified organism is made
only after it has given its approval in writing.

2. The Competent Authority shall evaluate the information presented by the
applicant or in the Clearing-House, as the case may be, and may decide that
the applicant:
i) needs to provide more information to enable decision making;
ii) may proceed with her/his/its request; or
iii) may proceed with her/his/its request but only under such conditions as
the Competent Authority may specify; or
iv) shall not be allowed to proceed with her/his/its request.

3. The Competent Authority shall notify the applicant in writing and the
public of its decisions, copied to the Clearing-House.

4. The Competent Authority may, prior to taking a decision, request for
further information as it may deem necessary and any applicant who fails to
supply the required further information shall be deemed to have withdrawn
her/his/its application.

5. Any approval shall specify the step-by-step sequences of implementation
that risk assessment shall be conducted at each step, provided that the
Competent Authority may, in appropriate cases, not require this procedure
if it is satisfied that there would be no risk / significant risk to human
health, biological diversity and in general the environment.

6. Any approval for import, transit, contained use, release or placing in
the market of a genetically modified organism shall require the applicant
to carry out monitoring and evaluation of risks on a continuing basis for a
period commensurate with the life cycle of the species, as determined by
the Competent Authority.

7. No approval shall be given unless there is a firm and sufficient
evidence that the genetically modified organism or the product of a
genetically modified organism poses no risks/significant risks to human
health, biological diversity and in general the environment.

8. In any event, where there is reason to suspect threats of serious
damage, lack of scientific evidence shall not be used as a basis for not
taking preventive measures.

9. No approval shall be given unless it is considered and duly determined
by the Competent Authority that the import, transit, contained use, release
or placing on the market of the genetically modified organism or the
product of a genetically modified organism will:
(a) benefit the country without causing any risk/significant risk to human
health, biological diversity and in general 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.

10. The Competent Authority shall, as a condition for approval, require the
applicant to furnish evidence of insurance cover or some other arrangements
sufficient to meet its obligations under this law.


ARTICLE 7
REVIEW OF DECISION

1. Any approval given may be revoked, or subjected to conditions in
addition to those originally imposed, if there has been a change in
circumstances, or if, in the opinion of the Competent Authority, new
information obtained or a review of existing information about the
genetically modified organism or the product of a genetically modified
organism indicates risks to human health, biological diversity and in
general the environment.

2. Where information becomes available after approval on the possible risks
to human health, biological diversity and in general the environment, the
applicant shall immediately notify the Competent Authority.


ARTICLE 8
RISK ASSESSMENT

1. The applicant shall carry out or cause to be carried out an assessment
of any risks associated with a genetically modified organism or a product
of a genetically modified organism in respect of which she/he/it is
applying.

2. No decision on any application to import, transit, make contained use
of, release or place on the market a genetically modified organism or a
product of a genetically modified organism may be made by the Competent
Authority without the assessment of risks to human health, biological
diversity and in general the environment, including the socio-economic
conditions and cultural norms.

3. The risk assessment of a genetically modified organism or a product of a
genetically modified organism shall be carried out by the applicant or the
Competent Authority as appropriate, on a case by case basis and shall be
done in accordance with Annex III.

4. The Competent Authority shall evaluate or cause the evaluation of the
risk assessment report and consider the result of such an evaluation in
making a decision on any application to import, transit, make contained use
of, release or place on the market a genetically modified organism or a
product of a genetically modified organism.

5. In case where the evaluation of the assessment shows that risks cannot
be avoided the Competent Authority shall refuse approval for the import,
transit, contained use of, release or placing on the market the genetically
modified organism or the product of a genetically modified organism.

6. In the case of a refusal to approve under paragraph 5 above, 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, as
the case may be.

7. The Competent Authority may require the applicant to bear all the costs
for evaluating the risk assessment report or carrying out the risk
assessment, as the case may be.

8. No person shall be involved in the evaluation of a risk assessment in
respect of a subject matter in which s/he 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 her/his participation in the
evaluation process. A person with a conflict of interest shall declare the
fact and withdraw from the evaluation process.

9. If an independent risk assessment cannot be undertaken, or if there is
no possibility of verifying the independence of the risk assessment, the
Competent Authority may reject the application.


ARTICLE 9
RISK MANAGEMENT

1. The Competent Authority shall develop, maintain and use, as the need
arises, a risk management strategy for protecting human health, biological
diversity and in general the environment from accidents in genetic
engineering, the use of genetically modified organisms, and their products.

2. The Competent Authority shall impose such measures, as may be necessary,
to implement Annex IV and to avoid adverse effects on human health,
biological diversity and in general the environment, including on socio-
economic conditions, arising from a genetically modified organism or a
product of a genetically modified organism.

3. Without limiting the generality of paragraphs 9(1) and 9(2), the
Competent 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, transit, contained use, release or placing on the
market of any genetically modified organism or the product of a genetically
modified organism, if it contains characteristics or specific traits which
pose unacceptable risks to human health, biological diversity, in general
the environment, socio-economic conditions or cultural norms;
(c) order the cessation of any activity, which is being undertaken in
violation of any of the provisions of this law 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 health, biological diversity and in general the
environment;
(e) require the person responsible for any activity under this law to take
such measures as may be necessary to prevent or limit any harm to human
health, biological diversity and in general the environment, or socio-
economic conditions, or to 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
safety measures prescribed by the Competent Authority;
(g) take measures, as necessary, in the case of imminent and serious danger
to human health, biological diversity and in general the environment, socio-
economic conditions, or ordre public caused by a genetically modified
organism or a product of a genetically modified organism, at the cost of
the person responsible for causing such danger;
(h) require the applicant to submit reports periodically in respect of the
monitoring and evaluation of risks carried out after the approval 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; and
(i) assess and, as necessary, prohibit the import, transit, contained use,
or release of a genetically modified organism or a product of a genetically
modified organism that may be used for a hostile purpose.


ARTICLE 10
UNINTENTIONAL RELEASE AND EMERGENCY MEASURES

1. In order to manage the unintentional release and/or emergency arising
from an accident with a genetically modified organism or a product of a
genetically modified organism, the Competent Authority shall, as necessary,
ensure, that:
(a) an emergency plan is drawn up for the protection of human health,
biological diversity and in general the environment outside the area of
release or contained use in the event of an accident and the appropriate
emergency services are aware of the hazards and are informed in writing; and
(b) information on safety measures and procedures to adopt in the case of
an accident is made available by the applicant to persons likely to be
affected by the accident. The information shall be updated and made
available periodically. It shall also be made available to the general
public.

2. The applicant shall inform the Competent Authority immediately of any
accident and provide the following information:
(a) the circumstances of the accident;
(a) the identity and quantity of the genetically modified organism or
products of genetically modified organism released unintentionally;
(c) any measure necessary to assess the effects of the accident on human
health, biological diversity and in general the environment; and
(d) the emergency measures taken or to be taken.

3. Upon receipt of the information under paragraph 10(2), the Competent
Authority shall:
(a) ensure that all measures possible have been taken to neutralize risks
to human health, biological diversity and in general the environment; and
(b) inform relevant government and non-governmental organizations in
countries likely to be affected, and the Biosafety Clearing-House.


ARTICLE 11
IDENTIFICATION AND LABELING

1. Any genetically modified organism or product of a genetically modified
organism shall be clearly identified and labeled as such, and the
identification shall specify the relevant traits and characteristics given
in sufficient detail for purposes of traceability.

2. Any genetically modified organism or any product of a genetically
modified organism shall be clearly labeled and packaged using the words
given in Annex II, part C, and shall comply with such further requirements,
if any, imposed by the Competent Authority, to indicate that it is, or has
been derived from, a genetically modified organism, and, where applicable,
whether it may cause allergies or pose other risks.


ARTICLE 12
CONFIDENTIAL BUSINESS INFORMATION

1. The Competent Authority shall protect information which it determines as
being confidential following a claim for confidentiality made in writing by
the applicant.

2. In no case may the following information supplied by the applicant be
kept confidential:
(a) description of the genetically modified organism or the products of a
genetically modified organism, names and addresses of the applicant,
purpose and location of the import, transit, contained use, release or
placing on the market of the genetically modified organism or the product
of a genetically modified organism;
(b) methods and plans for monitoring the genetically modified organism or
the product of a genetically modified organism and for emergency response;
and
(c) the evaluation of possible effects, in particular any pathogenic and/or
ecologically disruptive effects.

3. The Competent Authority may make available the information referred to
in Article 4(3) and 4(4) to the public pursuant to Article 5(1),
notwithstanding that it may be commercially confidential, if it decides
that it is in the public interest to do so.

4. If the applicant withdraws the application before approval, the
Competent Authority must respect the confidentiality of the information
except for the information referred to in subparagraphs (2) and (3) of this
Article.

5. Any person carrying out any activity covered by this law shall supply
information necessary for the Competent Authority to carry out its
supervisory or monitoring or enforcement tasks or to deal with any
emergency measures in relation to the activity and there shall be no claim
of confidentiality in relation to such information.


ARTICLE 13
EXPORT

1. Any person who intends to export a genetically modified organism or a
product of a genetically modified organism shall provide to the Competent
Authority a written advance informed agreement of the Competent Authority
of the importing country.

2. The presentation of the advance informed agreement by an exporter shall
in no way absolve the exporter from complying with any other laws governing
foreign trade.

3. The submission of the advance informed agreement shall not preclude the
country of the exporter from taking into account other considerations in
deciding whether or not to approve the export.

4. There shall be no authorization for the re-export of a genetically
modified organisms or product of a genetically modified organism that has
been banned by the laws of the exporting country.


ARTICLE 14
LIABILITY AND REDRESS

1. A person who imports, arranges transit, makes contained use of, releases
or places on the market a genetically modified organism or a product of a
genetically modified organism shall be strictly liable for any harm caused
by such a genetically modified organism or a product of a genetically
modified organism. The harm shall be fully compensated.

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.

3. If there is more than one person responsible for the damage, injury or
loss, then the liability shall be joint and several.

4. In the case of harm to the environment or biological diversity,
compensation shall include the costs of reinstatement, rehabilitation or
clean-up measures which actually are being incurred and, where applicable,
the costs of preventive measures.

5. In the case of harm to human health, compensation shall include:
a) all costs and expenses incurred in seeking and obtaining the necessary
and appropriate medical treatment;
b) compensation for any disability suffered, for diminished quality of
life, and for all costs and expenses incurred in reinstating, as far as
possible, the quality of life enjoyed by the person before the harm was
suffered; and
c) compensation for loss of life and all costs and expenses incurred for
funeral and other related expenses.

6. Liability shall also extend to harm or damage caused directly or
indirectly by the genetically modified organism or product of the
genetically modified organism to economic, social or cultural conditions;
including negatives impacts on the livelihood or indigenous knowledge
systems or technologies of a community or communities, or damage or
destruction arising from incidence of public disorder triggered by the
genetically modified organism or the product of a genetically modified
organism, disruption or damage to production or agricultural systems,
reduction in yields, soil contamination, damage to the biological
diversity, damage to the economy of an area or community, and any other
consequential damage.

7. The right to bring any civil action in respect of harm caused by a
genetically modified organism or a product of a genetically modified
organism shall, having due regard to the laws on limitations of rights
commence from the date on which the affected person(s) or the community, or
communities 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 reasonably take to correlate the harm with the
genetically modified organism or the product of the genetically modified
organism, taking into consideration the situation or circumstance of the
person(s) or community or communities affected.

7. Any person, group of persons, or any private or state organization may
be entitled to bring a claim and seek redress in respect of the breach or
threatened breach of any provision of this law, including any provision
relating to damage to human health, biological diversity and in general the
environment, or to socio-economic conditions:
(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 persons 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 above persons who fail in
any action as aforesaid 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 or biological
diversity.


ARTICLE 15
OFFENCES AND PENALTIES

1. Any natural or legal person who:
(a) imports, transits, releases, places on the market or makes contained
use of any genetically modified organism or products of a genetically
modified organism without the written approval of the Competent Authority;
(b) violates any conditions attached to the grant of approval under this
law;
(c) fails to furnish any information as required by the provisions of this
law;
(d) withholds information that has become available to her/him/it after the
approval of her/his/its application, and that could change the evaluation
of the risk posed by her/his/its project;
(e) provides false, misleading or deceptive information under Article 4.3
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 law
or with any conditions imposed under this law;
(g) labels, packages or identifies any genetically modified organism or a
product of a genetically modified organism in a manner that is false,
misleading or deceptive or in contravention of any regulation made under
this law;
(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 any proceedings related to decision taking in respect
of a subject matter covered by this law in which she/he/it has any direct
or indirect interest of any kind;
(j) violates any other provision of this law or any condition or
requirement imposed under this law;
(k) fails to declare any conflict of interest arising in a National or
Institutional Biosafety Committee of which s/he is a member, or in the
evaluation of a risk assessment in which s/he is involved, and fails to
withdraw from its activities in relation to that case;
(l) uses a genetically modified organism or a product of a genetically
modified organism for hostile purposes;
(m) obstructs or fails to assist the Competent Authority or other
authorized officers in the performance of their duties under this law;
(n) fails to inform the Competent Authority of an accident or emergency
involving a genetically modified organism or a product of a genetically
modified organism;
commits an offense and is liable on conviction to imprisonment for a term
not exceeding ………… years or to a fine or to both.

2. Any person shall upon conviction of any offense under this law shall be
prohibited from engaging in any activity in relation to genetically
modified organisms or products of genetically modified organisms.
Such order of prohibition shall extend to any corporation, body or legal
entity that may be used to avoid the effect of the said order.

3. Where the offense is committed by a corporation, and where the court
feels that a custodial sentence ought to be imposed, the executive officer
in charge at the time the offense is committed, shall be liable to
imprisonment.


ARTICLE 16
APPEAL

1. Any person aggrieved by any decision of the Competent Authority may, at
any time within the period of …… month(s) beginning from the date of
receipt of the decision, appeal to such ajudicatory and/or administrative
authority as may be set up by law.

2. In this section ‘decision’ includes any act, omission, refusal,
direction, imposition of condition(s) or order.


ARTICLE 17
TRANSITIONAL PROVISIONS

1. Regarding any import, transit, contained use, release, or placing on the
market of a genetically modified organism or a product of a genetically
modified organism that has already been carried out on the date when this
law enters into force, an application for approval shall be made in
accordance with Article 4 of this law.

2. The application shall be submitted to the Competent Authority within a
time limit to be determined by the Competent Authority.

3. If the application has been made within the prescribed time limit, the
activity in respect of which the application is made may continue until a
decision is made by the Competent Authority under Article 6 of this law.

4. Any application pending at the date of the entry into force of this law
shall be subject to the provisions of this law.


ARTICLE 18
ANNEXES

The Annexes and any regulations made under or pursuant to this law shall be
an integral part of this law.


ARTICLE 19
ENTRY INTO FORCE

This law shall enter into force on the date of its publication in the
official gazette.


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