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POLICY / BUSINESS: U.S. biotechnology industry approves ProductLaunch Stewardship Policy to minimize trade disruptions



                                 PART I
------------------------------- GENET-news -------------------------------
TITLE:  Biotechnology industry approves Product Launch Stewardship Policy
SOURCE: BIO, USA
AUTHOR: Press Release
URL:    http://www.bio.org/news/newsitem.asp?id=2007_0521_01
DATE:   21.05.2007
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Biotechnology industry approves Product Launch Stewardship Policy
New forward-looking policy statement encourages industry members to
minimize the potential for trade disruptions from agricultural
biotechnology products

Washington, D.C. (May 21, 2007) -- The Biotechnology Industry
Organization (BIO) today announced a new forward-looking policy
statement that will encourage BIO's Food and Agriculture members to help
facilitate the flow of goods in commerce and minimize the potential for
trade disruptions with respect to products of agricultural
biotechnology. The Product Launch Stewardship Policy addresses the issue
of asynchronous authorizations -- where different countries may approve,
deregulate or authorize biotech crop varieties at different times. Such
variance in regulatory authorizations among trading partners can
potentially disrupt trade and commerce of grain products.

Under the new policy, BIO is encouraging its members in its Food and
Agriculture Section to seek the appropriate regulatory authorizations
from major countries -- including the United States, Canada, and Japan --
prior to commercializing a new biotech-derived crop.

"Approval of the Product Launch Stewardship Policy is a significant
forward-looking action by BIO's Food and Agriculture Section Governing
Body," said Jim Greenwood, president and chief executive officer of BIO.
"It demonstrates that BIO is committed to doing our part to promote the
continued safety and trust in the world's food supply, and to help
support smooth trade transactions in the international grain community."

The Product Launch Stewardship Policy is an extension of domestic and
international efforts to develop and advocate for an adventitious
presence (AP) policy. Over the last several years, BIO and its members
have continually urged U.S. regulatory agencies to implement a science-
based policy that governs incidental or trace amounts -- or so-called
adventitious presence -- of biotechnology-enhanced events in raw and
processed grains and oilseeds, as well as food and feed. While
adventitious presence is a natural part of plant biology, seed
production, and the distribution of commodity crops, a science-based
policy would support continued food safety for consumers, farmers, food
processors, and grain handlers. In 2006, both the U.S. Food and Drug
Administration (FDA) and Environmental Protection Agency (EPA)
introduced their policies on adventitious presence; in March 2007, the
U.S. Department of Agriculture published its interim policy on
adventitious presence. Additionally, Codex Alimentarius, the
international food standards-setting body, has begun work to develop an
international food safety standard for adventitious presence.

"The Food and Agriculture Section Governing Body felt that it needed to
approve a prospective policy statement that demonstrates strong support
for the international trade system and its improvement," said Andrew
Baum, president of SemBioSys, Inc., Chair of the Food and Agriculture
Section Governing Body, and Vice Chair and Secretary of BIO's Board of
Directors. "We believe the approval of this Product Launch Stewardship
Policy demonstrates our understanding of the concerns grain handlers,
exporters, and foreign governments may have about new biotech-derived
crops, and it illustrates our organization's continued commitment to
promoting good product stewardship and responsible use of this technology."

In addition to encouraging authorizations in the United States, Canada,
and Japan prior to commercialization, the Product Launch Stewardship
Policy also encourages companies to consult with grain handlers and
others in the value chain, follow best seed quality practices, as well
as develop detection methods for growers, grain producers, processors,
and buyers. Finally, it encourages BIO members to promptly communicate
broadly and in a transparent manner with stakeholders their company-
specific product launch stewardship policies and their implementation.

Founded in 1993, BIO represents more than 1,100 biotechnology companies,
academic institutions, state biotechnology centers and related
organizations across the United States and 31 other nations. BIO members
are involved in the research and development of health-care,
agricultural, industrial and environmental biotechnology products. BIO
produces the BIO International Convention, the world's largest gathering
of the biotechnology industry.


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                                 PART II
------------------------------- GENET-news -------------------------------
TITLE:  Product Launch Stewardship Policy
SOURCE: BIO, USA
AUTHOR: 
URL:    http://www.bio.org/foodag/stewardship/20070521.asp
DATE:   21.05.2007
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Product Launch Stewardship Policy

Introduction

An increasing number of biotechnology-derived plant products /1 intended
for food or feed use are authorized for commercial production in many
countries throughout the world; however, authorizations in importing
countries vary depending on the timing of submissions for import
authorization as well as the duration of the authorization process in
each country. As a consequence of these asynchronous authorizations, low
levels of recombinant-DNA plant materials that have completed full
safety assessments, in accordance with national and international
standards, in one or more countries may, on occasion, be present in food
or feed in countries in which the authorization process of the relevant
recombinant-DNA plant material has not been completed.

Asynchronous authorizations combined with importing countries
maintaining "zero tolerance" for recombinant-DNA products not yet
authorized results in the potential for major trade disruptions. The
potential occurrences of trade disruptions will only increase given the
substantial amount of research that will bring many new products and
combinations of products to market. The problem could be further
compounded as countries that currently have no regulatory authorization
systems for biotechnology-derived plant products establish them in the
future. The potential for trade disruption could be significantly
reduced if all countries provided authorizations simultaneously or if
there were international governmental consensus eliminating zero
tolerance policies.

BIO's Food and Agriculture Section is committed and seeks the commitment
of the value chain to continue to actively engage in ongoing concerted
efforts to harmonize science-based agricultural biotechnology regulatory
approaches to achieve synchronous authorizations and to eliminate zero
tolerance policies. As a beginning, work in Codex is underway to develop
an international food safety standard for the low level presence of
recombinant-DNA plant material in food. Such an international standard
will help address the problem when completed, but it is not a substitute
for full safety authorizations. In the interim, one pragmatic approach
is to minimize the number of asynchronous authorizations in key markets.
This can be achieved by BIO Food and Agriculture Section member
companies commercializing their new biotechnology-derived plant products
after meeting applicable regulatory requirements from the key countries
most likely to produce or import the seed or products derived from those
new biotechnology-derived plant products.

BIO's Food and Agriculture Section establishes the following policy to
address these matters. /2


General Policy

To help ensure the continued adoption of agricultural biotechnology
globally and to continue to have products of agricultural biotechnology
bring value to the marketplace, BIO's Food and Agriculture Section
supports actions that facilitate the flow of goods in commerce and
minimize trade disruptions. BIO's Food and Agriculture Section believes
that henceforth individual member companies should, prior to
commercialization, /3 meet applicable regulatory requirements in key
countries identified in a market and trade assessment that have
functioning regulatory systems /4 and are likely to import the new
biotechnology-derived plant products.


Specific Policy Objectives

Consistent with this general policy, BIO's Food and Agriculture Section
believes that henceforth individual member companies commercializing
biotechnology-derived plant products should, and encourages them to:
- Conduct a market and trade assessment to identify key import markets,
including those with functioning regulatory systems, prior to the
commercialization of any new biotechnology product (crop by event) in
any country of commercial launch. In that market and trade assessment,
consult at an early stage with the value chain for the specific crop.
Manage the product's introductions so that choice of production methods
(i.e., facilitate coexistence) and markets (e.g., specialty, identity
preservation, and global) for that crop are available and preserved.
- Meet applicable regulatory requirements in key markets (which at a
minimum shall include the United States, Canada, and Japan /5) prior to
commercialization of a new biotechnology product in commodity corn,
soybeans, and canola in the United States or Canada, unless determined
otherwise in the consultation with the value chain for the crop.
- Follow generally accepted best seed quality practices designed to
prevent adventitious presence of unauthorized products and minimize
unintended incidental presence of products authorized in the country of
production pending full implementation of BIO's Food and Agriculture
Section Quality Management Program.
- Make available prior to commercialization a reliable detection method
or test for use by growers, processors and buyers that enables crop
identity verification for intended use.
- Promptly communicate broadly and in a transparent manner with
stakeholders as to its company-specific product launch stewardship
policies and their implementation.

In light of the constantly changing regulatory and trade environment,
the Food and Agriculture Section Governing Body will keep this policy current.

Policy approved: May 21, 2007


1/ Biotechnology-derived plant products or plant products derived from
modern biotechnology means the application of 1) in vitro nucleic acid
techniques, including recombinant deoxyribonucleic acid (DNA) and direct
injection of nucleic acid into cells or organelles or 2) fusion of cells
beyond the taxonomic family, that overcome natural physiological
reproductive or recombinant barriers and that are not techniques used in
traditional breeding and selection. This definition of modern
biotechnology has been adopted by the Cartagena Biosafety Protocol under
the Convention on Biological Diversity and the Codex Alimentarius Commission.

2/ Under BIO's bylaws and applicable antitrust laws, individual member
companies are not bound by this Association policy.

3/ Commercialization for this document is defined as the first planting
of seed sold into commerce for the production of a crop.

4/ A "functioning" regulatory system is science-based, with clearly
defined timelines and processes for regulatory review and decision-
making, and appropriate protection for proprietary information and data.
The regulatory and decision-making processes must be predictable,
completed in a timely manner, and not subject to undue political influence.

5/ Mexico will be added to this group of countries when it has developed
overtime a record of systematic authorizations with defined timelines
and processes.


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