Testimony of the Texas Healthcare & Bioscience Institute (THBI) before the Texas House Agriculture and Livestock Committee
Thursday, April 10, 2003
Regarding House Bill 3387: The Prohibition of Food Crops for the Production of Pharmaceutical, Industrial and Other Non-Food Materials
On behalf of the members of the Texas Healthcare & Bioscience Institute (THBI) and in conjunction with the Biotechnology Industry Organization (BIO) please accept this testimony in opposition to Texas House Bill 3387. If passed, this bill would ban the production of pharmaceutical and industrial materials in plants such as corn, alfalfa, rice, and safflower. Beyond limiting a very promising area of research, this legislation would severely harm the state's reputation as a center of excellence for technology development.
The potential of plant-based technology is enormous. Traditional methods of producing pharmaceutical and industrial proteins are time and capital intensive. In many cases, plant-based techniques offer a more expedient and economical way to mass-produce these proteins. Nature offers a flexible way to respond to these needs that brick-and-mortar facilities cannot. The result is increased supply, reduced production cost and increased investment in research-not just development-without the potential drawbacks of traditional fermentation methods or animal-based production.
Plant-made production of pharmaceutical and industrial proteins holds distinct advantages over current production methods. Most proteins cannot be chemically synthesized, therefore previous production options were limited to mammalian or microbial cell cultures which are time consuming and expensive to develop.
Commodity crops are a natural choice for protein production due to extensive knowledge and familiarity with growing these plants. Understanding of a plant's genetics, agronomics and environmental impact is crucial in the successful development, confinement and extraction of these proteins. Again, all this can be achieved without the inherent risk of propagating contaminants that are possible in other methods. In compliance with current federal regulatory guidelines, pharmaceutical or industrial protein-producing plants must be grown and processed separately from food and feed crops. After harvest, the plant material is processed to separate and purify the proteins, which are then delivered to manufacturers. In addition, the seeds to grow protein-producing plants are available only to those with an appropriate U.S. Department of Agriculture (USDA) growing permit, and cannot be purchased off-the-shelf at a local seed store.
- Stringent U.S. Department of Agriculture and Food & Drug Administration(FDA) requirements already exist to regulate the production of plant-based proteins. The USDA regulates plant-made pharmaceuticals during development and field production while FDA regulates the evaluation, production and distribution of pharmaceutical products. Several agencies within USDA and FDA further regulate and monitor plant-made pharmaceuticals:
These regulations are comprehensive, rigorous and national in scope. THBI feels that researchers and consumers are best served by a strong, uniform regulatory system-not a state-based patchwork of inconsistent guidelines.
- USDA's Animal and Plant Health Inspection Service (APHIS) oversees the process from seed through grain, including the transport and release of the seed in a greenhouse or field;
- the FDA Center for Biologics Evaluation and Research (CBER) and FDA Center for Drug Evaluation and Research (CDER), regulate biologic products/devices, including plant-made pharmaceuticals; and
- FDA Center for Food Safety and Applied Nutrition (CFSAN), and FDA Center for Veterinary Medicine (CVM), provide additional oversight as needed to ensure the safety of food and feed.
House Bill 3387 will only serve to create confusion about a promising area of research and impede the state's effort to grow its life science industries. This legislation is reactionary and would only serve to harm the state's reputation as a center of excellence for technology development-a reputation that has attracted, grown and retained so many outstanding research organizations. There are more than 500 companies in Texas working to develop a variety of life science products and technologies.
These companies account for more than 50,000 jobs. In addition, Texas is home to 55 medical academic institutions and research parks that are integral to the state's future development of a vibrant life science cluster.
We appreciate the committee's consideration of our concerns and encourage committee members to oppose House Bill 3387.
The Texas Healthcare and Bioscience Institute (THBI) is a public policy research organization comprised of biotechnology, medical device and pharmaceutical companies, as well as academic and private research institutions. The mission of THBI is to research, develop, and advocate policies and actions that promote biomedical science, biotechnology, agriculture and medical device innovation in Texas.
The Biotechnology Industry Organization (BIO) is the national trade organization, based in Washington, DC, representing more than 1000 biotechnology companies, academic institutions and biotechnology centers in all 50 states and 33 countries. BIO members are involved in the research and development of health care, agricultural and environmental biotechnology products.