November 15, 2002
Biotechnology Industry Organization (BIO) Executive Director
for Food and Agriculture Michael J. Phillips today issued the
following statement regarding regulatory infractions by
ProdiGene, Inc. as
announced by the Animal Plant Health and Inspection Service of
the U.S. Department of Agriculture:
"The ProdiGene incident demonstrates that the regulatory
framework governing plant-made pharmaceutical crops works.
USDA/APHIS identified violations of the federal permitting
system and has been effective in ensuring isolation of
pharmaceutical-producing plant material from grain intended for
food and feed production, thus ensuring the integrity of the
food supply.
"There must be zero-tolerance where public confidence in the
integrity of the food supply is involved. BIO supports vigorous
enforcement actions by the regulatory agencies in this matter.
This incident, however, should not overshadow the benefits of
this emerging technology. Plant-made pharmaceuticals can make
important contributions to human health including the production
of proteins for new drugs to treat and fight life-threatening
diseases. By using living plants instead of traditional
manufacturing methods, we can greatly increase the safety,
number and quantity of drugs available to patients, produce them
faster, and make them more widely available to those who need
them.
"BIO member companies are expected to rigorously adhere to all
legal requirements and federal regulations. BIO members look
forward to continuing to work closely with all interested
congressional and state delegations, USDA/APHIS, FDA and 'food
chain' stakeholders to ensure that development of this promising
new technology moves forward with appropriate safety and
safeguards, and that farmers' options to use this new technology
remain open under appropriate growing conditions."
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.
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