“Fourth Session of High Level Policy Dialogue on Agricultural - AIMP

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2008/SOM2/008


EXECUTIVE SUMMARY


APEC High Level Policy Dialogue on Agricultural Biotechnology




The 7
th

Meeting of the APEC High Level Policy Dialogue on Agricultural Biotechnology was held
February 27
-
28, 2008 in Lima, Peru, and was attended by 16 economies. It was
preceded by a
Private Sector Day. Main issues for discussion included commodity trade and the low
-
level presence
of regulated recombinant DNA plant materials in trade, implications of transparent policies and
regulations on the use of agricultural biotech
nology, and key concerns on liability and redress on
research and trade.

Following presentations and discussions, participants supported the following public policy
development activities
:


1.

The Policy Dialogue will develop and undertake work in 2008
to
develop a step
-
wise approach to
harmonization complementary to that proposed in the sub group for Research, Development and
Extension on Agricultural Biotechnology (RDEAB)
. RD
E
AB will develop

a staged plan for the
harmonization of the technical aspects of

regulation. This work meets an important objective
included in its 2007
-
2009 Work Plan, which is to recognize our complementary work to the
RDEAB, which the Senior Officials endorsed in September 2006.

It is also supportive of the
2006 Hanoi declaration

supporting a move toward regional economic integration.


2.

The Policy Dialogue should hold side meetings among APEC members at Cartagena and Bonn
to continue discussing a common position on liability and redress.


3.

The Policy Dialogue will continue the work

on public perception and risk communication to assist
economies on how to utilize the best practices guide, and to broaden the application of the
Investment Toolbox to pursue continued work on risk communication.




Recommendations

It is recommended that
the Senior Officials:


1. Endorse the final report and recommendations of the 200
8

meeting of the
High Level Policy
Dialogue on Agricultural Biotechnology
.
2008/SOM2/008



Seven
th

Session of High Level Policy Dialogue on Agricultural Biotechnology”

Lima
,
Peru

26
-
2
8

Febr
u
ary 200
8


1.

The Steering Committee of the High Level Policy Dialogue on Agricultural Biotechnology presents
to Senior Officials the final report
and recommendations
of the
S
even
th

Session of
the
APEC
High Level Policy Dialogue on Agricultural Biotechnology,
held
26
-
2
8

Febr
uary 200
8
. As directed
by the APEC Leaders in
Canberra

in 200
7
, the APEC High Level Policy Dialogue on Agricultural
Biotechnology was hosted by
Peru

in
Lim
a

and was attended by
1
5

of the 21 APEC economies
(Australia; Canada; Chile; Indonesi
a; Japan; Korea; Malaysia; Mexico; Peru; the Philippines;
Russia;

Chinese Taipei; Thailand; the United States; and Vietnam).


2.

Dr. Juan Risi Carbone, Head of the National Institute of Agricultural Research
, opened the Policy
Dialogue meeting and
offered som
e perspective on development and use of agricultural
biotechnology in
Peru
.
Dr
.

Risi

then introduced Ellen Terpstra, Deputy Under Secretary, Farm &
Foreign Agricultural Services, United States Department of Agriculture

and Chair of the Policy
Dialogue
.
D
eputy Under Secretary Terpstra welcomed the delegates and
shared her thoughts on
what the Policy Dialogue could and should strive to achieve during this meeting. She
stressed
that
the diversity of the
APEC economies
, including their differing levels of fa
miliarity with
agricultural biotechnology,
can

be used to
leverage APEC economy expertise and experience to
more effectively achieve
APEC’s

goals of promoting the development and responsible use of
agricultural biotechnology.
Deputy Under Secretary Terpst
ra
pointed out, however, that
significant challenges lay ahead, including the need to
have regulations, standards, policies and
systems in place to secure continued market access, particularly in light of
rapid
developments in
technologies.


COMMODITY TRAD
E AND THE LOW LEVEL PRESENCE OF REGULATED RECOMBINANT
-
DNA
PLANT MATERIALS IN TRAD



3.

The morning session focused on
commodity trade and the low
-
level presence of regulated
recombinant DNA plant materials in trade
.
There were three presentations: from
Dr. E
ric Flamm,
Senior Science Policy Advisor, Department of Health and Human Services, Food and Drug
Administration, from Dr. Ernelea Cao,
Professor and Director of the Nat
ural

Sciences Research,
Institute of the University of the Philippines and the Philippin
es permanent representative to the
Codex
Ad Hoc Intergovernmental
Task Force on
Foods Derived from
Biotechnology, and from
Dr.
Randal Giroux, International Grain Trade Coalition (IGTC).

Each
offered

the high level officials
an in
-
depth examination of the

issue of the trade and policy aspects of low level presence of
biotechnology
-
derived crops in commodity trade that are approved in the country of export but not
approved in the country of import.



4.

Eric Flamm

from
the U.S. Food and Drug Administration

sta
rted the session with his presentation
on
the current work in the CODEX Alimentarius Commission’s Ad
-
Hoc Intergovernmental Task
Force on Foods Derived from Biotechnology on guidelines for conducting a food safety
assessment in situations of low
-
level prese
nce of regulated
-
DNA plant material. Eric
first
ex
plain
ed

why a task force was developed
;
that
this powerful technology can introduce new
proteins into foods, and can alter or introduce new metabolic pathways, that food safety
assessments are typically on
ly used for specific chemicals: e.g., food additives, pesticides, and
that
those foods themselves have been presumed safe and have not been evaluated. He went
on to discuss what the taskforce accomplished in its first four years, 1999
-
2003
.
At the end of
its
4
-
year life in 2003, the Task Force had reached consensus on three documents to help
governments evaluate the food safety of biotechnology plants and micro
-
organisms
:

Principles for
the Risk Analysis of Foods Derived from Modern Biotechnology
;

Guidelin
e for Safety Assessment
of Foods Derived from rDNA Plants, plus allergenicity annex (Plant Guideline)
;

and Guideline for
Safety Assessment of Foods Produced
Using rDNA

Microorganisms.
H
e

then

discussed what the
taskforce accomplished in the second three y
ears, 2004
-
2007
:

Guideline for Food Safety
Assessment of Foods Derived from rDNA Animals, Annex to Plant Guideline
;

Food Safety
Assessment of Foods from rDNA Plants Modified for Nutritional or Health Benefits
;

and Annex to
Plant Guideline: Food Safety Asse
ssment in Situations of Low
-
Level Presence of rDNA Plant
Material in Food.


Through the recent work in Codes Code
x

on assessing the food safety risk of
unapproved biotech events present at low
-
levels,
he noted,
a greater global awareness of this
2008/SOM2/008


issue has
arisen.

While only providing guidance for risk
performing a food
safety
assessment, the
work in Codex challenges the APEC economies to consider how they might use a risk
safety
assessment to develop a strategy for risk management that can address both
foo
d
safety and
trade concerns in a practical manner.


5.

Dr. Ernelea Cao
,
Director of
the Philippine
Natural

Sciences Research Institute,

then delivered a
presentation on the Philippine
experience

with low
-
level presence of regulated recombinant
-
DNA
plant mater
ial
, and noted that the Philippines use the Codex guidelines for risk assessment, along
with their own national guidelines.
With their guidelines in place, the same science
-
based
assessment can be applied to low level presence of regulated recombinant
-
DNA

plant material.
She stated that low
-
level presence was a concern, because of the increasing number of
approvals globally, causing differences in the timing and duration of governmental regulatory
safety assessments (“asynchronous approvals”), pollen drif
t during crop production, use of high
-
volume receiving, storage and handling systems that optimize quality and minimize costs to
consumers, and because of the way grain is transported

globally.
She pointed out that the
Philippines has a national biotechno
logy policy “to promote the safe and responsible use of
modern biotechnology and its products as one of the means to achieve food security, equal
access to health services, sustainable and safe environment and industry development” Thus,
the
y

have develop
ed a strong legal framework on the importation and use of GMOs. This
framework specifically states that
no person shall be allowed to import or release into the
environment any regulated article without a satisfactory risk assessment that is science
-
based
,
transparent, and that is done on a case b case basis b
y

transformation event.

She further
outlined the risk assessment process in the Philippines, stressing that their science
-
based
evaluation procedure is independently evaluated for safety by scientist
s or experts in nutrition,
molecular biology, toxicology, allergenicity and other food science

area
s. Finally, Dr. Cao
summarized the
scientific and regulatory
challenges they face in the Philippines and in other
developing countries: the lack of adequat
ely trained scientific personnel; poor or limited access to
up
-
to
-
date information on new concepts and techniques; inadequate funding for laboratories;
s
etting
-
up of concrete national policies on low level presence

and whether to do
partial or full risk
as
sessment
s; and on
having
different definitions of low level presence.



6.

The third presentation on
low
-
level presence
was delivered by

Dr.
Randal Giroux, of the
International Grain Trade C
oalition
.
He began his presentation by showing that global demand fo
r
grains
and oilseeds

continues to grow mainly due to population and income growth and increased
animal protein consumption.
He outlined the importance of
an

international guidance in
facilitating trade
, and
noted that asynchronous approvals was the leadi
ng cause of low
-
level
presence of unapproved events in
export
grain
and oilseed

shipments.
He said the grain industry
was involved in the
LLP

discussion issue because agricultural biotechnology is here to stay, and
as national and international regulatory
frameworks emerge for modern biotechnology, the
food
and feed supply chain

will be
affected by
these

government decisions
.
Thus, the w
orld’s grain
industry must be
proactive

to advocate regulatory frameworks in their respective countries that
avoid disrup
tions

in the international trade of grain, oilseeds, pulses and derived products
. He
emphatically
stated

that “z
ero tolerance is the most disruptive policy for LLP in grain
and oilseed
shipments for food
,

feed
,

and processing” because zero threshold LLP p
olicies expose
the
grain
industry/importers to exceptionally high
financial
risk: demurrage (additional handling/storage
costs/ disposal costs). Further, he noted that neither Identity
-
P
reservation (IdP) nor grain
channeling can manage these events to ze
ro tolerance.
In some cases, to manage the risk of
zero tolerance of unauthorized events, exporters/importers may be required to stop offering
products to specific markets where zero tolerance policies are no longer commercially viable and
become a barrier

to trade. In these cases, where LLP policies are a barrier to trade, such policies
can result in trade stoppages and potentially domestic industry downsizing (such as domestic
animal protein production). The IGTC proposed a tiered approach for government
s to handle LLP
that should allow countries to maintain their supply of food and feed products in a marketplace
with increasingly limited supplies of these commodities and increasing introduction of new
products of modern biotechnology. The approach would
strive to first synchronize event
authorizations among countries whenever possible, by recognizing the exporting country’s risk
assessment system. The preferred out come would befor
e

importing countries to grant a full
authorization to the event, secondly
to use this full authorization in the exporting country, to
implement a r
i
sk management policy that moves off of current zero thresholds by announcing low
-
level marketing thresholds; and finally, for countries
to use

the Codex Low Level AP Risk
2008/SOM2/008


Assessment
Annex to conduct a low level presence risk assessment for the event and
subsequently authorize
a LLP

threshold. Randal ended his presentation by providing some advice
for APEC economies, namely to: s
upport the Codex LLP annex approval; proactively address

the
issue of LLP by getting
your private sector entities involved in the issue and starting an industry
-
government dialogue on the topic; and develop national policies that minimize the impacts of LLP
of agricultural biotechnology products by developing r
isk assessment policy that minimizes
asynchronous approval gaps between trading partners, that establishes policies for agricultural
biotechnology that create access and predictability for global supply chains, and that
acknowledge the need for and support

the development of practical and achievable standards for
low level presence in collaboration with industry



7.

The discussion that followed the presentations was lively and reflected the keen interest many
APEC economies have taken in the topic of
LLP
. Th
e discussion among the delegates noted the
practical challenges for commodity trade due to asynchronous approvals of biotech crops among
trading partners.

It was pointed out the potential negative implications for both importers and
exporters of failure to

take proactive decisions on LLP in commodity imports.


Mexico

asked
what
the industry position
was
on
pharmaceuticals

in plants.
On behalf of the IGTC, Randall Giroux

commented that
pharmaceuticals

are not used for food and feed, and thus
the grains indu
stry
had
no position. The United States

commented that
pharmaceuticals are not deregulated, and thus,
would not be in the food supply

without the conditions of regulation
.

Peru noted that
they had
confidence in the
U.S. safety review
process but also
adv
ised the participants to use the Biosafety
Clearing House (BCH)

for information and data to assist in doing their own proactive
risk
assessments
. The Philippines stressed the need for international policies/guidelines to deal with
the issue of LLP
, and po
inted to the soon to be ratified guidelines on LLP under the Codex
Alimentarius commission as one policy option available to APEC members to address decisions
around commodity trade
. Canada raised concern that biofuels would divert commodities away
from f
ood use, and thus impact food security. Korea cautioned economies to consider
environmental risks since most grain traded contained LMOs.

Australia described the proposal in
the RDEAB to do further work on regulatory
harmonization

while seeking policy g
uidance from the
HLPDAB and recommended that the two groups avoid duplication of effort and remain
focused

on
their core competencies. The ensuing discussion, supported by USA, Canada, Philippines,
Malaysia and Indonesia, proposed that the Policy Dialogue
undertake policy work complementary
to the work proposed by the RDEAB with respect to harmonization of the technical aspects of
regulation, while avoiding duplication of effort in the RDEAB working group and other fora such as
OECD.

Malaysia specifically n
ot
ed

the impact of LLP on the animal feed industry and trade.


Recommendation

1
:



The Policy Dialogue will develop and
undertake work in 2008 on harmonization
complementary to that proposed in the
sub group for Research, Development and Extension
on Agricul
tural Biotechnology (
RDEAB
)

with respect to a staged plan for the harmonization of
the technical aspects of regulation.
This work meet
s

an important objective included in its
2007
-
2009 Work Plan,
which is to recognize our complementary work to the RDEAB,
which
the Senior Officials endorsed in September 2006.


8.

Following a lunch hosted by

Peru’s National Institute of Agricultural Research,
the afternoon
session began with a report from the Private Sector Day, which was presented by
Sarah Lukie of
the Biotech
nology Industry Organization
. Sarah
provided participants with an overview of the
procedures followed for approval, handling, distribution and trade of these products around the
world, framed around the possible impacts of adventitious or low
-
level presen
ce. She stressed
the value of transparent and functioning regulatory systems for agricultural biotechnology
products, and introduced the private sector’s views on proactive policy options for managing low
level presence that will allow countries to mainta
in their supply of food and feed products in a
marketplace with increasingly limited supplies of these commodities. We also heard that the latest
data on global status of biotech crops demonstrates increasing acceptance of these products
worldwide, with th
e expectation that over 40 countries will be cultivating them by 2015, and the
vast majority of countries will have processes in place allowing import of these products for food,
feed and processing. Sara
h
’s presentation provided the high level officials
with concrete
examples of how the absence of national approaches to the issue of low
-
level presence has the
potential to disrupt trade; pose unnecessary liability risk to the agri
-
food chain; increase costs to
2008/SOM2/008


consumers; and increase the burden on regulato
ry agencies and the availability of needed food
supplies of importing countries.


IMPLICATIONS OF TRANSPARENT POLICIES AND REGULATIONS ON THE USE OF
AGRICULTURAL BIOTECHNOLOGY


9.

The afternoon session
was moderated by
Miguel Barandiaran
,
Advisor to the Hea
d of the
International Institute of Agricultural Research.

The session

continued with the agenda item on
implications of transparent policies and regu
l
ations on the use of agricultural biotechnology
.
There were three presentations, by
Mr. John B. Pitchfo
rd,
Acting Associate Deputy Administrator,
Biotechnology Regulatory Services, APHIS/USDA, Dr. Saturnina “Nina” Halos, Chairman of the
Department of Agriculture’s (DA) Technical Advisory Committee on Biotechnology, and
Consultant and Technical Chair of the
Applied Biotech Research Component of the DA’s Biotech
Program
, Philippines,

Dr.
Jose Falck Zepeda, Research Fellow, Environment and Production
Technology Division, International Food Policy Research Institute IFPRI


10.

John Pitchford explained APHIS’ respon
sibilities and discussed the importance of developing
transparent
regulator
regulator
y

systems that facilitate adoption of the technology and promote
agricultural trade. He noted that transparent policies increases compliance, helps audiences
know how dec
isions are made, builds public confidence, reduces costs and improves
one’s
ability
to coordinate both domestically and internationally.

Mr. Pitchford touched on APHIS regulatory
system goals, that they are: flexible; adapts to changing trends and new sc
ientific knowledge; is
rigorous, science
-
based, and easily understood; to the extent possible, encompasses interests of
all stakeholders; meets both domestic and international needs; ensures that oversight is
proportionate to the risks; and that is transpa
rent and encourages stakeholder input.
To date,
APHIS has issued determinations of non
-
regulated status in response to 71 petitions,
representing 14 crop species that can be used in food, feed, breeding programs in the same way
as their conventional counte
rparts.
APHIS is in the process of revising its GE regulations to
improve their understanding and to improve transparency. They also are developing a new
Biotechnology Quality Management System (BQMS) which will help researchers and developers
improve com
pliance
, focusing

on proactive measures. For example, the BQMS will include a
verification program that will recognize Hazard Analysis and Critical Control Point or ISO
Standards approach used by applicants for field trials. It also provides for audits a
nd inspections
of applicant procedures to augment the current compliance system. APHIS plans to conduct a
pilot project with one company and several universities in 2008 to assess the effectiveness of the
BQMS. To improve transparency, APHIS holds stakeh
older meetings with industry, crop
associations, academia and NGOs. It publishes Federal Register notices that allows for a public
comment period and public meetings. Moreover, APHIS regularly consults with other
governments, provides stakeholder update
s, and offers a BMS website and users guide.



11.

Following

Mr.
Pitchford’s

, presentation, we heard from
Dr. Satur
n
ina Halos from the Philippines,
who spoke about the importance of transparent and efficient regulations to public research and to
the private s
ector. She used the example of
how they navigated the regulatory
process for
Golden Rice, a public technology in the Philippines.

She identified Vitamin A deficiency (VAD) as
a global problem, and the leading cause of preventable blindness or severe visu
al impairment in
children, that increases the risk of disease
and

death from common severe infections, and in
pregnant women, causes night blindness and may increase the risk of maternal mortality.
S
he
emphasized that genetically engineered Golden Rice, c
ontaining
β
-
carotene and the
ir

provitamin
A carotenoids in significant amounts in its grains, was designed to help reduce VAD in developing
countries where rice is a staple diet, because it assists in converting the
β
-
carotene
and

other
provitamin A carote
noids
to Vitamin

A as needed in the body
. She mentioned that at the last
RDEAB meeting in Manila,
many

member economies expressed interest in this technology.
However, Ms. Halos stressed the need for regulatory oversight since Golden Rice has
a new
metab
olic pathway

that is derived from two non
-
food organisms (bacterium and daffodil)

not found
in ordinary rice
,
and that e
ach one should be evaluated separately
.
To allay fears provoked by
“anti
-
GMO groups”, the safety if Golden Rice needs to
be
adequately
assessed

she said
.
She
then outlined

considerations for
identify
ing

risk?

For example, she noted that first an allergenicity
test using the Codex guideline, CAC/GL 44
-
2003, should be conducted
, as she noted that
enzymes are proteins and some proteins are

allergens
.

She ended by discussing how you
facilitate early access to the Golden Rice technology once the risks have been identified and
2008/SOM2/008


evaluated. She mentioned that transparency in regulations, communication and consultations,
and harmonization of dat
a requirements were key to gaining access.

She said that interested
economies in Golden Rice might consider sharing costs in the development stage, might consider
accepting scientific data obtained outside their territories, and be willing to share risks
of common
concern.

Policy needs for each economy interested in the Golden rice

need to be considered
and
should
operate within a

transparent regulatory system for
ge

crops
.

She ended by repeating
that Economies wanting to cooperate with IRRI on
Golden
R
ice
need
to harmonize

their process
and procedures for Golden Rice, such as has been done between the
Philippines
and

India
.


12.

Following Ms
.

Halo
’s presentation
,

we heard from
Dr.
Jose Falck Zepeda, who
discussed the
economic impact of regulations, and

how
the cost of regulations could be a significant barrier to
the public sector in delivering biotechnology products that could benefit the resource poor.

He
talked about why we regulate GMOs, that there are safety
,

efficacy and public confidence issues
,
and b
ecause there is the need to address the call for 100 percent safe technologies.

He
outlined

the characteristics of a functional protective biosafety system

and identified who and what would
be affected by regulations.

Dr.
Falck Ze
peda then went on to ide
ntify the
costs of compliance

with
biosafety regulations by first mentioning that in it is important to explore the balance between a
country
-
defined acceptable level of safety and the necessary cost to achieve it. He quoted “avoid
investing good money in

safety issues that are trivial, manageable or irrelevant.” He presented a
chart comparing the difference in cost of compliance between Indonesia and the Philippines
,
noting that the cost of regulations can have a negative effect on the development of tec
hnologies
developed by the public sector. Technologies have been abandoned or delayed due to regulation
costs, and has resulted in some cases in a migration to non
-
regulated technologies where there
may be

less potential gains from the technology. He dem
onstrated how
the effects of time delays
and biosafety

regulations

affect the time value of money

using Bt cotton in the United States as
an example. Between 1996
-
1998, the benefits from the introduction of Bt cotton in the United
States to producers, con
sumers and the industry amounted to US$611 million. By delaying the
introduction
of Bt cotton
to 1999, the present value of the
net
benefits to al
l

stakeholders

decreased by 13.6 percent.
W
hen the cost of compliance

is added to the previous economic
esti
mations of benefits;

the present value of total bene
fits decrease
s

by 13.9 percent. This
example, he said, shows how delays and the cost of compliance negatively affect
the level of
benefits to producers and
developers.
Developers, according to

Dr.
Falck

Ze
peda
,
need
predictability when making investments
, U
ncertainty makes decision making more difficult and is
a disincentive for investment.

Costs impact consumers and producers as well, he said.
Ultimately, the cost of regulations
may be

passed on to th
e consumer through higher prices. He
presented data that compared the income benefits of GM crops to developing and developed
economies. In 2005, developed economies
realized a
45
-
percent increase in
farm
income, while
developing
economies farm income in
creased by

55 percent.
He ended his presentation by
outlining the steps needed to help the public sector meet biosafety requirements. Needed first is
capacity strengthening efforts for scientists, regulators, implementers and other stakeholders.
Second
ly, need streamlined regulatory approaches, that avoid requiring unnecessary data and
uses data generated elsewhere (certified labs),
evaluate and
explore alternative ways to asses
food/feed/environmental issues

that
are

based on science.


13.

There was a live
ly discussion following these three presentations on
transparency in regulations.
The Philippines asked IFPRI what was an acceptable level of regulatory cost, since surely there
will be a cost of compliance, and that field trials can be very expensive. Pe
ru
discussed the work
underway on transgenic potatoes but said the NGOs were slowing things down. Peru also said
that the fact that APHIS can do its own risk assessment is probably good because in South
America, often there are fights between the Ministri
es of Agriculture and Environment. Peru also
asked to hear more about the cost of not adopting the technology. IFPRI responded by saying
that a better way of measuring costs would be to measure the total cost of the technology
,
although still
not perfect
. There is a cost of time delays in not adopting a technology. But the cost
to not conducting research such as on rice is high compared to losing export markets by not
adopting the technology. Canada noted that Governments do regulate and are under incre
asing
pressure to increase transparency, saying the “white noise is blocking the actual question.” The
IFPRI speaker stressed that we need to present a robustness of regulating to the public. He said
you can look at the costs of not approving technologie
s that are safe compared to costs of
approving technologies that are not safe. However, in the end, we want to project a sense of
safety to the public.

Australia asked the Philippines how
it regulated

f
or Golden Rice. The
2008/SOM2/008


Philippines said its country an
d India were chosen to do the work on Golden Rice, because they
had regulatory systems in place that would allow them to pursue their research without delays.
Malaysia asked the United States how it conducted its public meetings and how was it possible to

control anti
-
biotech protesters. The United States responded by first saying that anyone can
attend the meetings, but it is important to select an appropriate place for the meeting.
The United
States said that no
-
one is ignored and that all views are ta
ken into account and recorded.
Ultimately, any decision is made based on science. The Philippines als
o

said that the
y

invite all
to
the
public meetings, but they ask the attendees to be very specific with their questions.



KEY CONCERNS ON LIABILITY AND
REDRESS ON RESEARCH AND TRADE


14.

Day 2 of the Policy Dialogue was moderated by
Dr
.

David Cunningham, Program Leader,
Biosecurity and Information

Sciences
, Bureau of Rural Sciences, Australian Government
Department of Agri
culture, Fisheries and Forestry. Dr
.

Cunningham
noted that Australia had
hosted the Policy Dialogue in 2007 and welcomed the opportunity to once again collaborate with
other APEC Economies on agricultural biotechnology.

Dr
.

Cunningham
then introduced the next
set of speakers whose topic foc
used on key concerns on liability and redress on research and
trade. There were 2 presentations
, from
:
Nobuyuki Kikuchi
,
Deputy Director, Global Environment
Division, International Cooperation Bureau, Ministry of Foreign Affairs
, Japan; and Alexander
Gro
bman, Advisor to the Minister of Agriculture, Peru.


15.

M
r. Kikuchi
provided
Japan’s
view on negotiating rules and procedures on Liability and Redress
under the Cartagena Protocol on Bio
diversi
ty. He began his discussion by saying that Japan is
the world’s l
argest importer of living modified organisms (LMOs). In 2003, Japan began
carrying
out its “Cartagena Law” to implement the CPB. Japan considers LMOs safe because there is no
scientific data to prove otherwise, and there have been no reported cases of ac
tual harm caused
by LMOs, and because of its potential as a new technology. It has the potential
,

he said
,

to help
reduce food prices, and alleviate hunger and poverty

as populations grow and demand increases
,
it can stave off food crises as demand increa
ses, and it helps countries like Japan, who are
dependent on food imports, to be assured of an adequate food supply. Too, he said, it
encourages continued research and development, which ensures food security. Mr. Kikuchi went
on to say that in Japan’s e
xperience, the regulatory regime under the Protocol is working, as it
uses a precautionary approach to managing risk of LMOs. With any new technology, there is
always risk and uncertainty
, but with the 10
-
year history with LMOs, there is reason to be
opti
mistic. He cautioned that the rules and procedures for Liability and Redress under the
Protocol should not become a barrier to trade. Given that many economies

depend on LMO
imports, any barrier would cause harm.
He invited non
-
Parties to join the protoc
ol and participate
in the negotiations vocally to represent APEC interests.

He also cautioned that Economies should
use pragmatism in the Liability and Redress negotiations and to steer away from ideology and
personal views about the technology.


16.

Following

Mr. Kikuchi’s presentation, we heard from Dr. Alex Grobman of Peru, who talked about
the common rules on liability and redress within the Cartagena Protocol. Dr. Grobman began b
y
first

talking about the goals of the Protocol
, that it was created to protec
t the environment and its
biodiversity. Among its provisions, there were rules to regulate the transboundary movement of
LMOs, which would be codified within a biosafety protocol.

He went into a discussion about
population growth and being able to provid
e enough food, which conventional agriculture, he said,
has reached its limit to keep up with the growing demand for food, and thus, the need for gm food.
He then stressed that, with this technology, came the need to protect the world’s biodiversity and
t
o manage risk
, beginning with a strong regulatory system
.

He identified the elements of a liability
and redress regime and the challenge
s of Article 27, which for Peru, he stated, it should be
handled at the national level because the perception of risk,
and the political, legal and economic
views are too different among economies to have a legally bin
d
ing agreement on Article 27.
Strict
liability under Article 27
would impose undue legal risks on importers and exporters
might
discourage operators from de
aling with GMOs.
Dr. Grobman went on to talk about the definition
of damage
, that it must be identifiable and objective, that it focuses on damage to biodeiversity
.
He further noted that, “the presence of a transgenic event in a population for which it w
as not
intended, does not constitute damage by itself. This is a key consideration underlying the whole
2008/SOM2/008


discussion on liability and redress, and which tends to be overlooked.” Damage, can be actual,
predictable or unpredictable, with unpredictable damage
, the basis of the precautionary principle.
Moreover, he stated that each GMO event must be evaluated separately before being released
into the environment
. Though there is no zero risk, it can be minimized in this manner. Loss of
crop biodiversity due
to GMOs, he said, should be studied independently of the evaluation.
Finally, he mentioned that as far as who was liable for damages

it should be
the originator of the
damage, whether it be
the farmers, the distributors,
traders,
regulatory agencies
or

th
e patent
owners.
He also noted that responsibility of proof of damage should rest with the claimant.
He
then went on to discuss Redress or compensation
, whether legal or physical to repair the damage
to
the
environment, and that can be attributed to the
effect of GMOs.

Compensation should be
determined at the national level as acceptance of a set of rules under the Protocol would not be
accepted by all parties, especially when many parties already have their

own national policies in
place. Finally, he c
autioned that care must be taken to not violate obligations under the WTO,
that imported products be treated no less favorably than national products, and that
requirements
for risk on GMOs be the same as other products that pose similar risks.



17.

Following

the two presentations, the moderator opened up the floor for discussion. Peru asked
Mr. Kikuchi to clarify the hazards we are dealing with and then how to avoid them. Mr. Kikuchi
stated
that he didn’t see any hazards but still worried about the possibil
ity of
risk that was where
Japan’s focus was. Korea noted that their situation was similar to Japans, that there is agreement
that GMOs are not hazardous, but the possibility of risk remains. Korea agreed with Peru that
Liability and Redress is complicat
ed, and fears the measuring damage is too complicated. The
Philippines agreed with Japan and Peru that a definition of damage should be included in the
negotiations, and that liability and redress should not hamper trade. The Philippines
recommended that

APEC economies should continue to discuss common procedures for liability
and redress. Malaysia mentioned that it plans to raise this discussion in upcoming meetings.
Japan supported working together with the APEC economies on liability and redress. Pe
ru
indicated that there are 2 was to look at GMOs, the scientific way, or b
y

taking the philosophical
position that ever
y
thing is possible, that if something isn’t proven, tha
n

it is possible.

The
challenge is to find a balance between the two positions,
and life without hazards would mean
living in a bubble. Thailand mentioned that they

now have biosafety legislation, but on liability and
redress, they can’t decide on how it should be addressed, that we need to discuss i
t

more. The
y

also agreed the APEC

needed to discuss the issue further. Peru
mentioned that the working
group is mainly staffed with lawyers, and have not been able to agree a single text. Peru
reiterated that the concepts behind those texts needed to be defined and agreed upon, and
sugg
ested that careful consideration needed to be given to defining what damage is. Scientific
and legal advisors should collaborate. Peru also agreed that there should be side meetings at the
Bonn meeting on these issues. Japan agreed that is should not ju
st be legal participants and
encouraged all agricultural fields be become engaged in the policy making process. The
Philippines noted that all stakeholders needed to be heard as it is their experience that some
stakeholders dominate the dialogue. Several

economies agreed

to

the proposal to meet in Bonn.
The United States also suggested that the APEC economies also meet in Cartagena. Canada
supported the second meeting, suggesting that it was important to meet as quick as possible.


Recommendation

2
:

The

Policy Dialogue should

hold side meetings among APEC members at Cartagena and Bonn to
continue discussing a common position on liability and redress
.



AGRICULTURAL BIOTECHNOLOGY PUBLIC POLICY DEVELOPMENT ACTIVITIES


18.

Dr
.

Cunningham

then
moderated

a series

of short presentations on agricultural biotechnology
public policy development activities being undertaken by the Policy Dialogue. The first
presentation was a report on APEC participation in
a

workshop
on Public Perception held in
October 2007 in Lima,
Peru. Dr. Banadiaran

provided
his

perspective on the workshop, which
, he
said shared the practical experiences of several countries that illustrated the tools and
approaches policy make
r
s may use

to communicate

with the public about agricultural
biotechno
log
y
.
This cumulated in development of a best
-
practices guide, and a proposal for a
follow
-
up activity to assist economies to put those tools into action.
Th
i
s presentation w
as

2008/SOM2/008


followed by a report on the
Investment Toolbox.

Dr. Andrew Powell

of Asia Bio
business
,
clarified
the goal of the Toolbox was

to identify current bottlenecks in the commercialization of
biotechnology products, and to promote greater bilateral relationships through support of
exchanges between APEC economies. He noted that
Asia Biob
usiness conducted
two needs
assessment meetings
last year, to be followed up by an initial target of one exchange per month
in 2009. He opined that these
bilateral interactions and exchanges will assist members in building
understanding and capacity to ad
dress the policy components necessary for stimulating
investment in agricultural biotechnology policy. The final presentation

was by Dr, Dong Hern Kim
of Korea, who provided a read out of the Sub
-
Group on Research, Development and Extension of
Agricultura
l Biotechnology (RDEAB) workshop, which was held February 21
-
25 in Lima, Peru.
The five
-
day workshop covered the following subjects
: the c
urrent status of agricultural
biotechnology in Peru; emerging areas of research and development in agricultural
bio
technology; public perception and communication of agricultural biotechnology; biosafety
regulations; regulatory synchronization/harmonization in the APEC context; and public
-
private
partnerships in agricultural biotechnology.
The main outcome of the works
hop was an agreement
by the member economies to pursue a program of work that would facilitate regulatory
harmonization. The APEC economies would identify common information requirements
surrounding the environmental assessment of agricultural products of

biotechnology, as these are
important starting points for effectively addressing public perception issues, and on how to
conduct risk assessments. It was agreed that a clear roadmap forward was needed in order to
ensure that the benefits of increased sync
hronization / harmonization

through reduced costs
and optimization of resources
--

are achieved by the regulated parties and member economies.



APEC UPDATES


19.

The APEC

Secretariat, Art Phanpob Plangpraoon,
provided
an

update on
APEC’s priorities, on
key out
comes in APEC in 2007
o
n
APEC Priorities for 2008
, and on next steps
. He said that
APEC continues to increase its understanding of WTO issues, that in the pursuit of global free
trade, each APEC economy should strive to remove trade barriers. APEC is a n
on
-
binding
process he noted, with decision making
done
b
y

consensus
, but Economies must keep in mind
APEC’s 1994 Bogor Goal of “free trade and investment in the region b 2010 for developed
economies and 2020 for developing economies.”
He noted that
APEC n
eeds

to maintain its
relevance to its stakeholders. He was, therefore, encouraged that at this meeting, there were
significant progress in moving away from merely information sharing and work towards more
value added activities such as formulating common p
ositions and harmonization efforts.

There
were some major outcomes in APEC in 2007. There was the Leaders Declaration on climate
change, energy security and clean development, endorsement of a report on Strengthening
Regional Economic Integration, includ
ing discussion on options for a Free Trade Area of the Asia
-
Pacific, increasing emphasis on APEC structural reform, and an endorsement of anti
-
corruption
principles for the public and private sectors. APEC priorities for 2008 are to work on social issues
that influence APEC goals of increased trade and investment facilitation

through increased
capacity building activities that will result in sustained economic growth in APEC economies.
Regarding next steps for APEC, he indicated that the SOM Steering Comm
ittee on ECOTECH is
looking at twinning arrangements and work placement programs, and the HLPDAB might explore
this type of arrangement. He supported more private sector and multilateral engageme
nt,
increased communication to the public, and questioned ho
w we could make the APEC Food
System more robust.
He then reminded the participants of the need to come up with projects
since it is an important tool to translate
strategy into

action.

The APEC Secretariat
the
n

mentioned APEC reform and introduced Dr. L
eonardo A. Gonzales of Strive Foundation,
P
hilippines
,

to provide

participants an overview of the Independent Assessment.

Dr. Gonzalez
noted that
four
APEC working groups, including the HLPDAB, are
currently
undergoing
independent assessments in order to f
ind ways to streamline the operations of the working
groups. He explained his methodology; that he will first look at the HLPDAB’s past
accomplishments

and review its performance relative to its APEC mandate
. Then

he will look at
the
activities undertake
n by the HLPDAB to determine if they meet the needs of the members.
Finally, he will survey whether the HLPDAB has focused on the relevant policy issues. He said
that he will circulate a draft of his analysis, conclusions and recommendations for comments

before submitting a final report to the APEC.


GENERAL DISCUSSION

2008/SOM2/008



20.

Dr Cunningham then opened the floor up to further discussion. The Philippines suggested that
Asia Biobusiness meet with relevant policy agencies and committees in the Philippines during t
he
exchange visits. Peru noted that public perception continues to be an important issue and
supported work by Asia Biobusiness on risk communication.

The United States stated that it felt
the Investment Toolbox was an effective communication tool and su
pported the application of a
Toolbox project on risk communication. Canada raised the issue of policy guidelines. The
Philippines responded stating that if some economies have laws that can’t be changed, then how
is it possible to achieve harmonization w
ithout a step
-
b
-
step process in place. Peru agreed that
differences in economies exist, but also stated that is was important to look at those regulations
that interfere with economic integration and restrict trade. Peru went on to support the
harmonizat
ion project and advised that it
begin soon. Korea agreed that harmonization was a
good concept but stressed the difficulties of economies having different regulations to deal with.
The United States replied that working towards harmonization is an import
ant goal for true
economic development, and suggested that the economies meet to define principles that would
assist in moving forward on the harmonization project. The Philippines supported using the
biosafety clearing house, as it is science based. Kor
ea supported technical harmonization of the
risk assessment process, and suggested that first, minimum data requirements for a risk
assessment should be the first step towards harmonization. Canada replied that it understood the
national issues among econ
omies, but supported the harmonization project and a meeting soon
to clarify and define the concepts of harmonization.

Peru reminded the members, that since some
economies are centers of origin for biodiversity, more care needs to be taken. Peru
recommend
ed that emphasis be placed on

science when determining the process for
harmonization.


Recommendation

3
:



The Policy Dialogue
will
continue the work on public perception and risk
communication

to
assist economies on how to utilize the best practices guide
,

and to broaden the application of
the Investment Toolbox to pursue continued work on risk communication.


CLOSE OF MEETING


21.

Following the show of support for
having
Asia Biobusiness

broaden the application of the
Investment Toolbox to work on risk communi
cation, the moderator turned the floor over to

Deputy
Under Secretary Teprstra, acting as the Chair of the Policy Dialogue,
to
summarize the one and a
half days of the Policy Dialogue meeting.
She noted the strong interest by the members in
pursuing work
on harmonization that will take the Dialogue in a new direction that will more
directly impact policies and thus economic development and trade in the Pacific Rim, and that
supports the vision outlined b the Senior Officials in the “Bogor Goals”
of

regiona
l economic
integration.
The Chair
commented on the discussion on the trade and research implications of
liability and redress regime under the CPB by supporting the proposal for APEC economies to
hold side events at the meetings in Cartagena and again in
Bonn to facilitate a common position
on liability and redress. The Chair
noted the interest in
developing transparent regulatory
systems that facilitate adoption of the technology and promote agricultural trade. That it increases
compliance helps audience
s know how decisions are made, builds public confidence, reduces
costs and improves ones ability to coordinate both domestically and internationally. She
mentioned that the 2007
-
2009 Work Plan will conclude next year and that it was time to develop a
new
Work Plan. This Plan, she said, should take into consideration the
priorities that the Policy
Dialogue outlined, that seek

to reduce the disparities that exist regarding policy and regulatory
frameworks among member Economies, that recognizes the compleme
ntary work to the RDEAB
,
and that recognizes the value of engaging with the private sector during our Policy Dialogue.
With that,
s
he thanked all the high level officials for their participation and concluded the s
even
th
meeting of the Policy Dialogue

by saying she looked forward to seeing everyone in Singapore
next year and in working with them this year to help further shape a new vision for the Policy
Dialogue.


The moderator then adjourned the meeting.