NOTICE ……. OF 2005
DEPARTMENT OF AGRICULTURE
I, Angela Thokozile Didiza, Minister of Agriculture
hereby publish the draft Biosafety Policy, 2005, for comment by the general
public. Comments must be submitted in writing within 30 days of publication of
this notice to:
Dr J.B. Jaftha
The Senior Manger: Genetic Resources Management
National Department of Agriculture
Private Bag x250
0001
Physical Address:
Harvest House Room 259
Fax: (012) 319 6329
E - Mail SMGRM@nda.agric.za.
A. T. Didiza
Minister of
Agriculture
BIOSAFETY
POLICY
1. Introduction
Biosecurity and biosafety are two risk management measures
used to achieve biological compliance, i.e. identifying applicable rules and
regulations for handling biological organisms, complying with the rules and
regulations, obtaining the necessary approvals and permits, and following
specified conditions and practices for specific organisms and activities. Genetically modified organisms are only one
group of organisms subject to biological compliance.
Biosecurity refers to ensuring the security of biological
materials to prevent theft, illicit use, or release. Biosafety focuses on reducing accidental
exposure to and release of biological materials. Successful biosecurity and biosafety programs
should be integrated to leverage common solutions.
Biosecurity has direct relevance to food safety, the
conservation of the environment (including biodiversity), and sustainability of
agriculture. Biosecurity is composed of
three sectors, namely food safety, plant life and health, and animal life and
health. One element contained in these
sectors is the introduction and release of Genetically Modified Organisms
(GMO’s) and their products.
The White Paper on Science and Technology and the National
Biotechnology Strategy of South Africa acknowledged that biotechnology can play
a major role in addressing national imperatives such as reducing the impact of
HIV/ AIDS, job creation, rural development, urban renewal, human resource
development and regional integration.
However, the use
of modern biotechnology for the development and possible deployment of
Genetically Modified Organisms (GMO’s) is also accompanied by definite
potential risks, impacting on biosafety and biosecurity. Effective, efficient, improved and updated
international frameworks and standards to support appropriate national action,
as well as national frameworks to regulate, manage and control biosecurity for
food and agriculture, including forestry and fisheries is essential. Policies and frameworks must however permit
practical implementation, increase cost effectiveness and improve consistency
across sectors.
Establishing credible and effective safeguards is thus critical for
maximizing the benefits of biotechnology while minimizing its risks. It is in view of this that a biosafety
policy, applicable to contained application as well as controlled and
uncontrolled release of GMO’s as it relates to the current and future
application in agriculture and human and veterinary medicine, is required.
This policy will offer guidance for sustainable development by providing
for mechanisms to ensure the safe use of biotechnology so as to strengthen the
economy and enhance livelihoods without prejudice to public health or the
environment.
2. Definitions/Glossary
of terms
‘Biosafety’or
‘biological safety’
means the management of risks to human and animal health
and safety, and to the conservation of the environment, as a result of
activities with genetically modified organisms.
’Biosafety
Clearing House’
means a clearing house mechanism as
established under article 18 (3) of the Convention.
‘Biosecurity’
encompasses all
policy and regulatory frameworks (including instruments and activities) to
manage risks associated with food and agriculture (including relevant
environmental risks), including fisheries and forestry.
’convention’
means the Convention on Biological
Diversity.
'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;
'genetically modified organism'
means any living organism, the genes or genetic material of which has
been modified in a way that does not occur naturally through mating or natural
recombination or both, and 'genetic modification' shall have a corresponding
meaning;
‘Living
modified organism”
means any living organism that possesses
a novel combination of genetic material obtained through the use of modern
biotechnology, within the context of the Cartagena Protocol on Biosafety;
‘Living
organism’
means any biological entity capable of
transferring or replicating genetic material, including sterile organisms,
viruses and viroids;
‘Modern
biotechnology’
means the application of: (a) In vitro
nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and
direct injection of nucleic acid into cells or organelles, or (b) Fusion of
cells beyond the taxonomic family, that overcome natural physiological
reproductive or recombination barriers and that are not techniques used in
traditional breeding and selection;
'monitoring'
means the maintaining of regular surveillance over, the checking of,
the warning about or the recording of a situation or process;
'risk'
means the probability of causing or incurring a loss or damage or an
adverse impact or a misfortune;
3. Problem
statement
Biotechnology
brings with it a number of potential risks.
However, it should not be construed that because there is potential
risk, that the risk will materialise.
With our current knowledge, the potential risks associated with
biotechnology can be categorised into human and animal health, the conservation
of the environment, including biodiversity, socio-economics, public awareness,
education and participation, national and global security, cross-sector
regulation and regulatory management.
3.1
Human, animal and plant health
Potential risks
associated with human, animal and plant health include eexpression levels of the protein at different growth
stages as well as different organs, foreign protein levels in food derivatives,
the potential for toxicity, pathogenicity and allergenicity. The source of the gene, nature of host
organism, comparisons of the DNA and protein, feeding tests, skin tests and
clinical trials are also important.
Other factors would include unexpected products and effects, changes in
nutrition, composition, digestibility and digestion products. It is also
important to evaluate gene expression in time, and compare the levels of
expression in different tissues, at different locations and at different
intervals in the growth cycle. Protein integrity
is important.
3.2
Conservation of the environment
Any
development, application and release of GMO’s must be conducted in manner that
will ensure the conservation and sustainable use of natural resources. Factors that could adversely impact the
environment are unexpected persistence of the gene or transgene in the
environment, volunteers, transgene products, susceptibility of non-target
organisms, unpredictable gene expression or transgene instability, risks of
horizontal gene transfer and potential ecological
impacts.
3.3
Socio-economic factors
The socio, economical and cultural factors, including the value of
biological diversity to indigenous and local communities, must be taken into
account. Although these factors are not
directly related to biosafety, it is an international obligation in terms of
the Cartagena Protocol on Biosafety and of importance to support a sustainable
agricultural sector, health sector, etc.
3.4
Public awareness, education and participation
Apart from establishing measures and procedures to obtain biosafety,
one cannot disregard the importance of public acceptance of GMO’s and GMO
products, and also public confidence in the Government to ensure adequate
safety in the development, application and release of GMO’s in SA. Facilitating public awareness, education and participation
is a requirement under the Cartagena Protocol on Biosafety, an international
agreement to which SA is Party signatory to.
Access to
information on the biosafety framework, as provided for by the Promotion of
Access to Information Act, 2000 (Act No. 2 of 2000), must be provided to third
parties. Access to information will
facilitate public assurance in the regulatory management of GMO’s. Furthermore, a key factor influencing public acceptance of GMO’s is the ability of
consumers to make an informed choice on whether they wish to consume a GMO
product or not. In this regard,
labelling plays an integral part.
Notwithstanding the right of access to information, the biosafety
regulatory framework must also make provision for the protection of certain
information classified as confidential information and is in accordance with
the provisions of Chapter 4 of the Promotion of Access to Information Act, 2000
(Act No. 2 of 2000).
3.5 National
and global security
A plethora of national and international regulatory systems/agreements
have evolved in response to the perceived risks of biotechnology products. Several international bodies/institutions are currently attempting to
coordinate and regulate different aspects of food safety and environmental
protection. International organizations seek to develop standards for health, safety,
and labelling for GM foods, establish testing procedures to ensure that set
standards are met, provide rules for allowable policies and create systems to
manage disputes. Despite the substantial
effort being undertaken, there is no common view on the goal of international
regulation. While most agree that safety
is the bottom line, few can agree on what that safety means or how to handle
non-safety issues such as social, economic, or ethical concerns.
3.6 Cross-sector
regulation
Activities with
GMO’s are accompanied with potential risks in various sectors, including
agriculture, health, environment, labour, science and technology, and trade and
industry. Bearing this in mind, the
potential impact of a GMO activity on each sector has relevance. The national or even international agreements
or legislative requirements pertaining to the sector must be taken into
consideration to protect biosafety.
Notwithstanding
the advantage of having a cross-sectoral approach in a biosafety framework,
this should be managed effectively to ensure that legislative requirements in
all sectors are effectively addressed.
Existing legislation to take into consideration include the Genetically
Modified Organisms Act, 1997 (Act No. 15 of 1997), the Environmental Conservation Act, 1998 (Act
No. 73 of 1998), the National Environmental Management Act, 1998 (Act No. 107
of 1998), the National Environmental Management Biodiversity Act, 2004 (Act No.
10 of 2004), the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54
of 1972), the Animal Diseases Act, 1984 (Act No. 35 of 1984), Agricultural
Pests Act, 1983 (Act no. 36 of 1983), the Fertilizers, Farm Feed, Agricultural Remedies and Stock
Remedies Act, 1947 (Act No. 36 of 1947), the Medicines and Related Substances
Amendment Control Act, 1997(Act No. 90 of 1997), Promotion of Access to
Information Act, 2000 (Act No. 2 of 2000) and the Promotion of Administrative
Justice Act, 2000 (Act No. 3 of 2000).
3.7 Regulatory
management
Apart from establishing an effective biosafety regulatory framework, is
the implementation of such a framework of critical importance to maintain
biosafety. One requirement is sufficient
capacity with regard to human resources to enable effective administration of
such a framework. Elements that require
attention are prescribed administrative procedures in terms of the Promotion of
Administrative Justice Act (PAJA), 2000 (Act No. 3 of 2000) and the provision
of information and data to third parties through the Promotion of Access to
Information Act (PAIA), 2000 (Act No. 2 of 2000).
4. Objectives
The objectives of this policy are the following.
1.
To establish common measures,
requirements and criteria for risk assessments, environmental impact
assessments and assessment of the socio-economic impact to ensure that GMO’s
are appropriate and do not present a hazard to the environment, human, animal
or plant health, taking into consideration the potential risks mentioned in
paragraph 3 above.
2. In
recognition of the constitutional right of access to information held by the
State on matters pertaining to GMO’s, promote
and facilitate access to information not classified as confidential in terms of
Chapter 4 of PAIA, public awareness, education and participation in the
biosafety regulatory framework.
.
3
Support and facilitate capacity building,
with particular reference to regulatory management, risk assessment, risk
management and risk communication, including the development of a roster of
experts in biosafety.
4
Aim to
cooperate with other developing countries, especially countries in the region
with overlapping borders, in harmonizing regulatory oversight in
biosafety. Special attention must be
given to developments within the Southern African Customs Union (SACU) and the
Southern African Development Community (SADC).
5. Policy to address the problem
5.1
Policy options
5.1.1 Preventative approach
A preventative
approach would imply that activities related to GMO’s are only approved in the
absence of any scientific uncertainty and knowledge regarding the potential
adverse effects of the GMO on the environment, human, animal or plant health,
i.e. when there is zero risk.
5.1.2
Precautionary approach
This approach will
be based on the precautionary principle as stated in various international
documents, such as the Rio Declaration on Environment and Development, 1992
(Principle 15), the Cartagena Protocol on Biosafety and the World Trade
Organisation 1993 Agreement on Application of Sanitary and Phytosanitary
Measures (Article 5.7). The
precautionary principle, as provided for in the Cartagena Protocol on Biosafety
is as follow: “Lack of scientific certainty due to insufficient relevant
scientific information and knowledge regarding the extent of potential adverse
effects of a living modified organism on the conservation and sustainable use
of biological diversity in the Party of Import, taking also into account risks
to human health, shall not prevent that Party from taking a decision, as
appropriate, with regard to the import of the living modified organism.... in
order to avoid or minimize such potential adverse effects”.
This policy will aim
to protect the environment, human, animal or plant health against uncertain or
unidentified risks, allowing use of the technology only to the extent that its
impacts are known or can reliably be predicted.
5.1.3
Coherent approach
This policy approach
would promote the development of an implementable regulatory system for
biosafety and guide its coordination with related regulatory mechanisms such as
phytosanitary requirements, variety registration, etc. This policy will provide a basis for a
scientific approach and case-by-case decisions, but also accommodating the
differing interests of ministries of agriculture, health, science and
technology, environment, or other sectors involved. Implementation of the regulatory system will
also contain elements of precaution
Policy decisions
regarding the relative roles played by the various ministries involved will
shape biosafety implementation. The
statutory nature of the biosafety regulations, whether issued as legislation or
as advisory guidelines, will dictate the nature and extent of enforcement
measures and the means for addressing non-compliance.
Existing regulatory
agencies such as those for plant quarantine, animal quarantine and variety
registration may have statutory authorities that apply to GMO’s and that need,
therefore, to be coordinated with biosafety regulation.
5.2
Recommended policy option
It is recommended
that policy option 5.1.3, i.e. a coherent policy approach, be chosen as an
approach for SA. This approach will
enable a cross sector regulation of GMO activities through implementation of
different legislation by different ministries.
Implementation of this approach will also be supported through
compliance with existing or anticipated national instruments.
One can only prevent
a risk from being realised if all risks are eliminated prior to commencement of
an activity. Bearing in mind that no
activity can commence without zero risk, the preventative approach is not
recommended. It would not only be very
difficult to conduct any activity without potential risk being involved, this
approach will limit SA in taking advantage of the benefits that this technology
can offer.
While there is no
controversy about the usefulness of the concept of precaution per se, there has been much debate about
its nature, in particular whether it is a legal principle in addition to being
a sound policy approach. Some argue that
the concept of precaution has not attained the status of a principle of law,
and hence does not as such constitute a legal obligation. It should be noted that although the
precautionary principle has been reflected in a number of international
agreements, including the Cartagena Protocol on Biosafety, countries utilize
different formulations and differences remain as to the proper scope of
application of the principle and its practical implications. The precautionary principle has also
potential to cause conflicts with international trade rules. Bearing this in mind, following a pure
precautionary principle is not recommended.
However, it should be noted that elements of precaution is still
essential and should be incorporated into the coherent approach.
5.3 Policy
Instruments
In support of the
coherent policy approach, the following instruments will be used for
implementation of the recommended policy option.
(i)
Genetically
Modified Organisms Act, 1997 (Act No. 15 of 1997)
The aim of the Genetically Modified Organisms (GMO) Act is
to provide measures to ensure that all activities involving GMO’s are conducted
in a manner that will limit potential risks associated with such activities to
the environment, human, animal or plant health; to give attention to
the prevention of accidents and the effective management of waste; to establish
common measures for the evaluation and reduction of the potential risks arising
out of activities involving the use of genetically modified organisms; to lay
down the necessary requirements and criteria for risk assessments,
environmental impact assessments and assessment of the socio-economic impact;
to establish a council for genetically modified organisms; to ensure that
genetically modified organisms are appropriate and do not present a hazard to
the environment; and to establish appropriate procedures for the notification
of specific activities involving the use of genetically modified organisms
A multidisciplinary
evaluation process shall be applied through the Genetically Modified Organisms
Act (GMO Act). Proposed activities will
be assessed on two levels. An Advisory
Committee shall make a recommendation to the Executive Council, based on its
evaluation of risk assessment data and other relevant information, on the
biosafety merits of the proposed activity.
The Executive
Council shall include members from relevant
government departments and the chairperson of the Advisory Committee. Each Council member shall consider respective
policies and legislation within his/her sector. A decision will include consideration of the
application, AC recommendation and public input. Permits shall be issued on instruction by
the Council.
Compliance to permit
conditions shall be monitored through the departmental inspection services and
the Border Control Strategy within the Department of Agriculture.
The Department of
Agriculture shall endeavour to build capacity with regard to human resources
and skills in the Advisory Committee, Executive Council, Appeal Board,
inspection services and office of the Registrar. This will include the development and
maintenance of a roster of experts in the field of biosafety. The Department of Agriculture shall further
promote public awareness and participation with regard to the regulation of
GMO’s and, as appropriate, work with the Public
Understanding of Biotechnology (PUB) programme.
(ii)
Transit
Policy of GMO’s
South Africa is one of the few African countries that have
formally adopted the use of genetically modified crops. The majority of African countries, including
SADC countries, have not formally adopted the use of modern biotechnology in
their agricultural systems. The reasons
for this vary, depending on the country.
However, many African countries, including SADC countries, often accept
food aid that contains GM material.
Distribution of food
aid to Southern Africa often transits through SA, which has biosafety
implications for SA. In view of the
potential biosafety concerns related to transit movements of GMO’s, the
Executive Council approved a GMO transit policy. This policy requests for, inter alia confirmation letters from the
recipient country indicating their willingness to accept food aid, while
acknowledging that it may contain GMO’s. The policy also makes provision for a
notification letter in advance of the proposed activity, procedures with regard
to handling and packaging and an undertaking by the donating country.
(iii)
Environmental
Conservation Act, 1998 (Act No. 73 of 1998)
The Environmental Conservation Act (ECA), 1998 (Act No. 73 of
1998) provides for the effective protection and controlled utilization of the
environment. In terms of Section 21 of
ECA, the Minister of Environmental Affairs and Tourism has identified
activities in Schedule 1 of the Act as activities which may have a substantial
detrimental effect on the environment.
These activities are prohibited
unless written authorization is issued either by the Minister of Environmental
Affairs and Tourism or a competent authority.
Such authorization is only considered after reports of the impact of the
proposed activity on the environment has been compiled and submitted in the
prescribed manner.
The genetic
modification of any organism with the purpose of fundamentally changing the
inherent characteristics of that organism is one of the activities listed. Bearing this in mind, the provisions of ECA
must be taken into consideration by the Executive Council in their
deliberations on any proposed GMO activity.
(iv)
National
Environmental Management Act, 1998 (Act No. 107 of 1998)
The National
Environmental Management Act (NEMA), 1998 (Act No. 107 of 1998) provides for
cooperative environmental governance by establishing principles for decision
making on matters affecting the environment.
Section 2 of NEMA sets out the national environmental
management principles, with the aim to ensure that all activities are conducted
in a sustainable manner. This requires
that risk assessment and risk management procedures be undertaken prior to the
approval of any proposed activity with GMO’s.
Risk assessment and risk management procedures are incorporated into the
provisions of the GMO Act.
Section 3 of NEMA calls for the appointment of two
institutions, viz. (1) the National Environmental Advisory Forum (NEAF) that
can advise and inform the Minister of Environmental Affairs and Tourism
regarding the application of the principles of risk assessment and management
and (2) the Committee for Environmental Co-ordination (CEC) to promote the integration
and achievement of the purpose and objectives of environmental implementation
plans and environmental management plans (Section 11), of which one objective
is the protection of the environment of the country as a whole.
(v)
National
Environmental Management Biodiversity Act, 2004 (Act No. 10 of 2004)
This National Environmental Management Biodiversity Act (NEMBA),
2004 (Act No. 10 of 2004) was enacted
within the framework of NEMA and institutes special requirements for the
introduction of three categories of living organisms, viz. alien species,
listed invasive species and threatened or protected species.
The objectives of the Act are –
(a) within the framework of NEMA, to provide for—
(i)
the management and conservation of biological
diversity within the Republic and of the components of such biological
diversity;
(ii) the use of indige