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October 30, 2008
Source:
SEAMEO SEARCA
Rationalizing and Harmonizing
Plant Biotechnology Regulations in Southeast Asia*
by Carlo G. Custodio, Jr.
Program for Biosafety Systems [PBS] Southeast Asia
SEARCA Policy Brief 2008 - 4
The tune is far from being synced. A wide variation exists on
the status of biosafety regulations in Southeast Asia.
Some countries have operational regulations, while others have
no regulation at all. Lao PDR has no biosafety regulation in
place; Thailand has no legislation specific for GMOs; Cambodia,
Indonesia, Malaysia, and Vietnam have biosafety regulations that
are still under development or not yet fully operational; and
the Philippines has already an operational system.
With regard to approvals for planting, there have been none in
Indonesia since 2001 when Bt cotton was approved for planting in
limited areas in South Sulawesi.
There are no approvals for commercial planting in Thailand, but
there are fields trials of PRSV resistant papaya approved in
December 2007 – only in government facilities and subject to
many conditions. In the Philippines, three single events and one
combined trait were approved for commercial planting.
Are there ways to harmonize?
The answer is yes – the
tight way and the loose way.
• Tight harmonization
Centralized approvals – a centralized regional approval
committee exists. The committee may agree on a mutual policy
recognition where there is a set up for a single region –
wide set of approval procedures. Decision – making process
is carried when one member government in the region grants
an approval for the import or planting of a GMO crop, then
that approval, if there are no objections from other member
governments – automatically becomes a generalized approval
throughout the region.
On the other hand, pre-emptive disapproval happens when
countries in a region reach a pre-emptive decision to not
approve GMOs at all for import, research, or commercial
planting anywhere in the region.
• Loose harmonization
Four options can be taken:
1. Set a common minimum standard of precaution for the
region regarding GMOs;
2. Centralize assessments but nationalize approvals;
3. Harmonize information and collaboration requirements.
This is done by formulating agreements on the exchange of
information regarding regulatory decisions, technologies
assessed, and regulatory expertise / know how. This implies
extensive use of Biosafety Clearinghouse and reciprocity
between pact members.
4. Adoption of standards, procedures, and guidelines for
testing.
What is happening right now?
Technology transfer
There are ongoing biotechnology transfer projects in Asia.
These include:
• Delayed ripening and PRSV resistant papaya;
• Bt, salt / drought tolerant Golden rice;
• Virus-resistant and late blight resistant potato;
• Virus-resistant tomato; and
• Bt eggplant.
Countries can receive these technologies only when they have
exiting biosafety regulations in place.
How can we harmonize Plant
Biotechnology Regulations?
1. Adopt standard testing
methods based on sounds science for GM detection and risk
assessment. A system of laboratory (and scientist)
accreditation that will be recognized across the region
should be developed.
2. Facilitate regulatory data exchange. The Biosafety
Clearing House (BCH) provides a mechanism; however other
mechanisms outside of the BCH need to be explored. An option
is to form a consortium of public institutions involved in
biotechnology R and D.
3. Prepare and share Consensus Documents on the biology of
crops through the OECD model. For example, Thailand can be
responsible for papaya, and the Philippines for eggplant,
and Vietnam for rice.
4. Agree on standard system for identifying and collecting
data sets (especially environmental risk data) to be
required for biosafety approval.
5. Engage in capacity building activities for regulators.
* In March 4 – 7, 2008, the
"Rationalizing and Harmonizing Plant Biotechnology Regulations
in Southeast Asia: A Learning Forum" was held in Bangkok,
Thailand to address this issue. The forum was co organized by
SEAMEO SEARCA, PBS Southeast Asia and National Center for
Genetic Engineering and Biotechnology (BIOTEC).
Harmonizing Plant Biotechnology Regulations
Efforts to rationalize and harmonize regulations in plant
biotechnology in the Southeast Asian region have been done. The
basis of all of these is the "ASEAN Guidelines on Risk
Assessment of Agriculture related Genetically Modified Organisms
(GMOs)", which was endorsed by the ASEAN Ministers for
Agriculture and Forestry held on October 28 – 29, 1999 in Bandar
Seri Begawan, Brunei Darussalam. To facilitate implementation of
the guidelines, a series of four workshops on "Safety and Risk
Assessment of Agriculture related GMOs" held in 2001 – 2004,
were organized in collaboration with the International Life
Sciences Institute (ILSI). Since 1999, the S and T and the Food,
Agriculture and Forestry Sectors of ASEAN have implemented a
total of 13 projects relating to biotechnology. The latest ASEAN
activity on biotechnology, the "ASEAN US Roundtable on ASEAN
Agricultural Biotechnology Policy and Strategy", was held in
Bangkok on April 4 – 5, 2006.
We also note the Singapore initiative to establish an "ASEAN
Genetically Modified Food (GMF) Testing Network". The Special
Senior Officials Meeting of the 25th Meeting of the ASEAN
Ministers of Agriculture and Forestry (Special SOM-25th AMAF)
held on August 11 – 13, 2004 agreed to establish a Task Force,
led by Singapore, to drive this Network.
The forum, therefore, saw the SEARCA – led initiative to promote
rationalization and harmonization of biotechnology regulations
as a continuation of these efforts. The forum also recognized
ASEAN as the appropriate organization to pursue these goals, and
offer our cooperation to achieve them. We affirm the
recommendations made during the recent "ASEAN US Roundtable on
ASEAN Agricultural Biotechnology Policy and Strategy". |
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