[searcabic] NEWS FEATURE: Playing the same tune: Harmonizing biotechnology regulations across Southeast Asia

Thu Oct 30 09:58:26 CST 2008

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*Posted 30 October 2008*

*PLAYING THE SAME TUNE: HARMONIZING BIOTECHNOLOGY REGULATIONS ACROSS
SOUTHEAST ASIA1*
*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.

###
*1 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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necessarily reflect the views of SEARCA.

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