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.