Agriculture Reference
In-Depth Information
Among the African countries, South
Africa is the major GM crop grower. h e
regulation of GMOs in South Africa is
dei ned in the Genetically Modii ed
Organisms Act (GMO Act, Act No 15, 1997),
its subsequent amendments and their
applicable regulations (Act No 23 of 2006)
(South African Government, 1997). h e Act
is intended to provide an 'adequate level of
protection' during all activities involving
GMOs that may have an adverse impact on
the conservation and sustainable use of
biological diversity and human and animal
health. h e GMO Act regulates the dif erent
authorization granted to GMOs in South
Africa, namely contained use, i eld trials,
import, commodity clearance (import for
food and/or feed use) and general release
(commercial plantings, food and/or feed
use, importation and exportation). h e
GMO Act is implemented by the Directorate
Biosafety of the Department of Agriculture,
Forestry and Fisheries and is administered
by the GMO Registrar.
Under the GMO Act, two regulatory
bodies are involved in the risk assessment
and risk management of GMOs in South
Africa:
the Advisory Committee, composed
of independent scientists with dif erent
scientii c backgrounds, and the Executive
Council, composed of representatives from
government departments. According to the
regulations, the risk assessment of GMO
applications is conducted in a scientii cally
sound manner and takes into account the
following steps: (i) identii cation of any
potential adverse ef ect resulting from the
novel genotypic and/or phenotypic char-
acteristics of the GMO; (ii) evaluation of the
likelihood of these adverse ef ects, taking
into account the level and kind of exposure
to the GMO; (iii) evaluation of the con-
sequences should these adverse ef ects be
realized; and (iv) estimation of the overall
risk posed by the GMO based on the
evaluation of the likelihood and con-
sequences of the identii ed adverse ef ects
being realized.
Further information on the authorization
of GMOs in South Africa can be found at
Many countries and regions around the
globe have, or are currently putting into
place, regulatory frameworks, operational
procedures and detailed guidelines for the
safety assessment of GM plants and derived
food and feed. Even in the frame of our
limited comparison, it is evident that,
despite general international agreement
recognizing comparative assessment as the
core principle for GMO risk assessment,
dif erences in statutory and non-statutory
approaches regulating food and feed derived
from GM plants exist among countries. h is
calls for continuous ef orts towards a global
harmonization of regulatory frameworks
and an international standardization of
scientii c requirements in order to enhance
the comparability of risk assessments
performed in dif erent countries. Ultimately,
such ef orts would promote harmonization
ef ectively, and consequently would boost
trade in GM food and feed commodities.
Novel traits of GM plants in the
developmental pipeline are those targeting
metabolic or physiological pathways, either
through a direct alteration of the existing
pathways or through the insertion of new
pathways. h ese 'second-generation' GM
plants have been modii ed deliberately to
enhance their nutritional properties or to
improve their resistance to biotic and abiotic
stresses. h ese novel traits pose new
challenges to current risk assessment
strategy based on comparative assessment,
as there may be no comparator against
which the food and feed products derived
from these second-generation GM plants
can be measured (CAC, 2007b). Ef ectively,
this will make application of the substantial
equivalence concept less straightforward.
In recent years, the development of
new breeding technologies, allowing the
insertion of foreign genes into crops'
genomes at specii c locations, has promoted
the broadening of gene pools to levels
unachievable with traditional breeding.
h ese genomic changes are generally dii cult
to detect (Lusser
et al
., 2011) and pose new
challenges to the molecular characterization
