Washington, DC
October 3, 2003
Today the Biotechnology
Industry Organization
(BIO) announced an industry-wide initiative to extend
understanding of compliance with federal regulatory requirements
governing all crops and plants improved through biotechnology.
“The biotechnology industry has a strong
commitment to product stewardship. The continuing advancement of
the technology combined with the growing complexity of the
federal regulatory system requires that we constantly revisit
our training methods, understanding, and adherence to stringent
federal requirements,” said Dr. Michael J. Phillips, vice
president for food and agriculture science and regulatory policy
of BIO.
“With this initiative,” added Phillips, “BIO’s
member companies have agreed to pool the knowledge gained over
16 years of experience in bringing new products safely to market
and share it throughout the agricultural sector, including
commercial entities, farmer-cooperators and academic
institutions. The desired outcome is consistent understanding
and performance in meeting federal guidelines for regulatory
compliance.”
Phillips noted that work for the program began
last fall with the creation of a “Beyond Compliance” task force
that identified three product stewardship objectives. They are:
(1) to achieve consistent compliance with all regulatory
requirements in research, development and commercialization of
food and agriculture products; (2) establish capacity building
and education tools to meet future needs; (3) and develop
transparent systems to record and communicate our results and
performance. BIO has contracted with AGBIOS to develop training
materials and lead pilot learning workshops before the 2004
growing season.
“We have chosen AGBIOS as our partner to execute
this program because of their global experience in the areas of
regulatory and biosafety capacity,” said Phillips.
“We are excited about this new assignment to help
the biotech industry provide consistent training across all
agricultural sectors,” said Morven McLean, president of AGBIOS.
“The industry already has a strong foundation of training in
place – our job is to build on what exists today to meet the
needs of the future and to ensure consistency across all
parties, both private and public.”
Previous industry commitments to stewardship have
included a 2000 announcement that promised assurance that U.S.
marketing of biotech seeds for commodity grain for food and feed
use would occur only after fully meeting all U.S. regulatory
requirements for both human and animal consumption; support of
comprehensive and rigorous science-based regulations as required
by the appropriate regulatory agencies, including the U.S.
Department of Agriculture (USDA), U.S. Food and Drug
Administration (FDA), and the Environmental Protection Agency
(EPA). BIO has also endorsed a mandatory pre-market notification
process for FDA review of all biotechnology food and feed
products.
The Biotechnology Industry Organization (BIO)
represents more than 1,000 biotechnology companies, academic
institutions, state biotechnology centers and related
organizations in all 50 U.S. states and 33 other nations. BIO
members are involved in the research and development of
health-care, agricultural, industrial and environmental
biotechnology products. For more information on BIO, visit our
website at www.bio.org
AGBIOS is a Canadian company dedicated to
providing public policy, regulatory, and risk assessment
expertise for products of biotechnology. AGBIOS has worked with
federal departments and agencies on issues of policy and
regulation pertaining to genetically modified and other novel
foods, crops, and forest tree species. The Company also provides
experience and expertise to commercial enterprises seeking
regulatory approval of biotechnology products, and to other
public and private sector groups seeking clarification of issues
associated with the development and utilization of biotechnology
processes and products.
In the area of regulatory and biosafety capacity
building, AGBIOS has developed training programs for the
environmental and food safety risk assessment of genetically
modified crops. These have been used by third parties as well as
for the Company's own use in delivering training workshops in
Africa, Latin America, and Southeast Asia.
www.agibios.com
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