GRP ADOPTS CONFLICTED BIOSAFETY FRAMEWORK

UNCLAS SECTION 01 OF 03 MANILA 001862

SIPDIS

SIPDIS

SENSITIVE

STATE FOR EB/TPP/ABT FOR SPIRNAK AND GOETHERT
STATE PASS USDA/FAS/ITP FOR SIMMONS, RICHEY AND CLARKSON
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STATE PASS USDOC FOR 4430/ITA/MAC/KBOYD

E.O. 12958: N/A
TAGS: EAGR ETRD ECON SENV TBIO TSPL RP
SUBJECT: GRP ADOPTS CONFLICTED BIOSAFETY FRAMEWORK

REF: 05 Manila 12

SENSITIVE BUT UNCLASSIFIED, NOT FOR INTERNET, PROTECT
ACCORDINGLY


1. (SBU) Summary. President Arroyo issued an executive
order (EO) adopting the National Biosafety Framework
(NBF) as a compliance mechanism under the Cartagena
Protocol on Biosafety (CPB). The NBF, a compromise
between pro- and anti-biotech policy makers, promulgates
conflicting principles in recognizing the need for
science-based risk assessments while allowing social,
cultural, and ethical considerations to guide biosafety
decisions. Adding non-science based requirements could
make the existing regulatory system more restrictive,
complicated, and detrimental to GRP Department of
Agriculture and donor efforts to use biotechnology to
promote agricultural productivity and food security.
Without a funding mechanism, however, implementation of
the EO will likely stall. End Summary

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National Biosafety Framework Adopted
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2. (U) President Gloria Arroyo recently signed EO 514,
establishing the National Biosafety Framework (NBF),
prescribing guidelines for its implementation, and
strengthening the National Committee on Biosafety of the
Philippines (NCBP). The GRP approved the new framework
despite DA, industry, and Post advocacy to use solely
science-based assessments and move out socio-economic
considerations from the coverage of the NBF (reftel). As
a compromise, the drafters of the EO regarded non-science
based assessments as discretionary provisions (versus
mandatory as found in earlier versions of the NBF) that
agencies may choose to require from technology
developers. The EO also clarified that the 2002 DA
Administrative Order No. 8 or the commercialization
guidelines shall continue to be in force and applied in
the evaluation and monitoring of plant and plant products
derived from modern biotechnology, assuaging industry
fears that the EO would disrupt the existing regulatory
system.


3. (U) The NCBP, a multi-sectoral committee chaired by
the Department of Science and Technology (DOST),was
tasked to oversee implementation of the NBF and set
scientific, technical, and procedural standards on
biosafety. The committee is composed of the secretaries
of the Departments of Agriculture, Health (DOH),
Environment and Natural Resources (DENR),Foreign Affairs
(DFA),Trade and Industry (DTI),and Interior and Local
Government (DILG); biological, physical, environmental,
health, and social scientists; and representatives from
consumer, community (such as farmer, fishermen, or
indigenous people),and industry groups.


4. (U) The NBF is the Philippines' compliance mechanism
to the Cartagena Protocol on Biosafety (CPB). Framers of
the NBF contend that the framework will strengthen
current science-based determination of biosafety and
enhance decision-making by incorporating social,
economic, ethical and cultural assessments.
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New Administrative Set-up
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5. (U) NCBP reorganization to include DTI, DFA, DILG,
and appoint representatives from consumers and industry
could be completed in early 2008. In the meantime, NCBP-
member agencies will continue to perform their regulatory
functions, as follows:

-- DOST will ensure that best available science is
utilized in adopting biosafety policies, measures and
guidelines and will take the lead in evaluating and
monitoring biotech articles intended for use in
laboratories and greenhouses.

-- DA will address biosafety issues in promoting
agricultural productivity and food security and will take

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the lead in evaluating and monitoring plants and plant
products derived from biotechnology.

-- DENR will ensure that environmental impact assessments
are considered in biosafety decisions and will take the
lead in evaluating and monitoring biotech articles
intended for bioremediation and genetic and wildlife
resources improvement.

-- DOH will formulate health assessment guidelines and
will take the lead in evaluating and monitoring processed
food derived from or containing biotech products.


6. (U) As required under Article 19 of the CPB, DFA is
the focal point for liaising with the Protocol's
Secretariat. The above-mentioned agencies were also

SIPDIS
designated as competent national authorities for
performing administrative functions under the Protocol.
The NCBP Secretariat was designated the focal point for
the Biosafety Clearinghouse, in compliance with Article
20 of the CPB. It will coordinate with the Protected
Areas and Wildlife Bureau (PAWB),an attached agency to
the DENR and the focal point for the Clearinghouse
Mechanism under the Convention on Biological Diversity.

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Conflict Between Social and Scientific Principles
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7. (U) The EO recognized several widely accepted guides
to biosafety decision-making. It prescribed that risk
assessments must be science-based and carried out on a
case-by-case basis or applied to a "transformation
event." In addition, consistent with WTO Sanitary and
Phytosanitary harmonization rules, the EO reasserted the
importance of expert advice from international bodies and
regulatory authorities of countries with experience in
biotechnology. The EO also subscribed to a more flexible
"precautionary" approach in Articles 10 and 11 of the CPB
that the lack of scientific knowledge or consensus does
not indicate a particular level of acceptable risk.


8. (SBU) On the other hand, the EO adopted several
other principles that directly conflict with science-
based standards. For example, the EO drew from Article
28 of the CBP in permitting social, economic, ethical,
and cultural assessments prior to commercialization. The
EO also gave flexibility for GRP agencies to jointly
issue environmental impact assessment guidelines as a
requirement for biosafety decision-making. These
additional requirements may be inconsistent with WTO
principles and would likely lengthen the approval process
and make the regulatory system tedious and prone to
corruption. It could also make it more expensive for the
private sector and public institutions -- which rely on
meager national government budgets -- to commercialize
their biotech innovations.

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Industry Reactions
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9. (SBU) Monsanto, an American company, is concerned
that as a result of the EO, biotech commercialization
rules may become more restrictive and arbitrary. The
company anticipates difficulty renewing its permit to
commercially propagate Bt corn (MON810, the first biotech
food crop approved for commercial release in Asia),which
will expire in 2007. They are particularly worried about
the DENR's environmental impact assessment system, which
they perceive as prone to corruption. Biotech Coalition
of the Philippines President Ben Pecson was surprised
that the President signed the EO after it had languished
in her office for nearly two years. He said the EO is
inconsistent with the national policy to promote the use
of biotechnology to address economic development goals.

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Another Unfunded Mandate
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10. (SBU) The reorganization of the NCBP will commence

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only after an inter-agency group concludes an agreement
to share financial and technical resources. Without its
own funds, the NCBP would have to rely on ad hoc
allocations from member agencies or external funding to
implement the NBF and embark on capacity building
programs identified in the EO. The DENR-PAWB is
requesting additional funding from the United Nations
Environmental Program's Global Environment Facility (UNEP-
GEF) to implement the EO, just as it did a $175,000 grant
in 2003 to develop the NBF. PAWB officials said the
signing of the EO is an important milestone in securing
additional funding for capacity building. Another is
ratification of the CPB by the Senate, which started
hearings and will likely ratify before the end of the
year.

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Comment
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11. (SBU) DENR and anti-biotech NGOs succeeded in
securing the legal basis for adding non-science based
assessments in the biosafety regulatory system. Although
the NBF is toned down from earlier versions, it could
complicate the biotech regulatory system and delay
approvals for the use of GM products. Under the new
rules, the biosafety assessment process -- from
greenhouse to single site to multi-site to commercial
release -- could take at least two years to complete.
Approvals could take much longer if required to address
non-science based considerations. The adoption of the EU-
like provisions could undermine the Philippines'
leadership role in agricultural biotechnology in Asia.
Post will continue to monitor developments and work with
the GRP and industry partners in assessing the EO's
impacts on the biotech policy environment.

KENNEY