Agriculture Reference
In-Depth Information
legislative frameworks and administrative
measures to safeguard the commercial
release of GM crops and their derived
products.
In China, the State Council in 2001
passed the 'Regulations on administration
of agricultural GMO safety', which was
implemented via i ve administrative
measures for the safety of (i) import, (ii)
labelling, (iii) biosafety assessment, (iv) GM
food hygiene and (v) inspection and
quarantine of the import and export of
agricultural GMOs (for details see Chapter
13). h e Ministry of Agriculture (MoA) is
responsible for the i rst three administrative
measures. GMO developers legally based
outside of the Chinese mainland must i le an
application to the MoA if they want to
import GM material into China, either for
commercialization or for experimental
trials. h e MoA twice a year entrusts
institutions to perform environmental and
edible safety tests and designates a national
committee to review the application
documents and the test reports. h e MoA
issues a safety licence within 270 days. h e
application must include a marketing
approval certii cate issued by the exporting
country/region. So, only GM products
approved for food and feed uses elsewhere
can be imported into China. h e 'Implement-
ation regulations on safety assessment of
agricultural genetically modii ed organisms'
(MoA, 2002) dei ne the two principles for
the risk assessment of GMOs for agricultural
uses (environmental release, food and feed
uses) in China: the comparative assessment
and the case-by-case approach. h e MoA
uses a class-based system (Classes I-IV
categorizing unknown, low, medium and
high risks, respectively) to determine the
safety of the recipient organism, the type of
genetic modii cation that inl uences the
safety of the recipient organisms, the safety
of the GMO, the production and/or
processing activities that inl uence the
safety of the GMO and the safety of the
derived GM products. h e Ministry of
Health (MoH) is responsible for the
administrative measures on GM food
hygiene, dealing with GMOs for medical
and pharmacological uses. h e
Administration of Quality Supervision
Inspection and Quarantine (SAQSIQ) is
responsible for the administrative measures
for the inspection and quarantine of GM
products. h e latter two administrative
measures, being outside the scope of this
book, are not discussed further.
Further information on GMO authori-
zation in China can be found at
http://
In India, the regulation of all activities
related to GMOs and derived products is
governed by 'Rules for the manufacture, use,
import, export and storage of hazardous
microorganisms, genetically engineered
organisms or cells' (commonly referred to as
Rules, 1989) under the provisions of the
Environment (Protection) Act of 1986,
through the Ministry of Environment and
Forests (MoEF, 1989). h e rules are
implemented primarily by the MoEF, the
Department of Biotechnology (DBT) and
the Ministry of Science and Technology
through six competent authorities: the
Recombinant DNA Advisory Committee
(RDAC); the Review Committee on Genetic
Manipulation (RCGM); the Genetic Engine-
ering Approval Committee (GEAC); the
Institutional Biosafety Committees (IBSC);
the State Biosafety Coordination Com-
mittees (SBCC); and the District Level
Committees (DLC). h e rules are very broad
in scope and essentially capture all activities,
products and processes related to or derived
from biotechnology including GM food and
feed, thereby making the GEAC the
competent authority to approve or reject the
release of GM food and feed in the
marketplace.
Further information on GMO authori-
zation in India can be found at
http://
In Japan, the safety assessment of foods
and feedstuf produced by recombinant
DNA techniques has been mandatory under
the food sanitation law since April 2001. GM
food and feed are dealt with by dif erent
ministries, all following similar scientii c
requirements. h e Ministry of Health,
Labour and Welfare (MHLW) receives
applications for GMO marketing, and the
State
