BIO Testimony regarding Oregan Senate Bill 570

Testimony of the Biotechnology Industry Organization
to the Oregon Senate Environment & Land Use Committee

Regarding Senate Bill 570: The Oregon Genetically Engineered
Pharmaceutical and Industrial Crop Act

April 8, 2005

On behalf of the members of the Biotechnology Industry Organization
(BIO), please accept this testimony in opposition to Oregon Senate Bill 570.
If passed, this bill would ban—for a four year period—the outdoor
production of pharmaceutical and industrial materials in any plants that may
be used for food or feed. Examples of prohibited plants would include corn,
alfalfa, rice, and safflower. In addition to limiting a very promising area of
biomedical research, this legislation would severely harm the state’s
reputation as an emerging 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 capitalintensive.
In many cases, plant-based techniques offer a more expedient and
economical way to mass-produce these proteins. Nature offers a more
flexible way to respond to these needs than do brick-and-mortar facilities.

Plant-made production of pharmaceutical and industrial proteins holds
distinct advantages over current production methods. Many proteins are
difficult or impossible to synthesize with traditional chemistry. Therefore,
previous production options were limited to mammalian or microbial cell
cultures, which are time consuming and expensive to develop. Plant-based
technologies can result in increased supply, reduced production cost and
increased investment in research—not just development. These benefits of
Senate Bill 570 plant-based technology are shared by consumers, specifically patients who
could have increased access to life-saving treatments for a wide variety of
diseases.

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. Plants used for pharmaceutical and industrial protein production
are selected based on the specific target protein and scientists familiarity
with that plant’s system. Again, all this can be achieved without the inherent
risks often associate with traditional production methods, i.e., fermentation,
mammalian cell culture.

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:

• USDA 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;

• States participate with USDA Animal and Plant Health Inspection
Service (APHIS) in the permitting and inspection;

• 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

These regulations are comprehensive, rigorous and national in scope.
Researchers and consumers are better served by a strong, uniform regulatory
system than a state-based patchwork of inconsistent guidelines.

Senate Bill 570 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 hard
earned reputation as an emerging center of excellence for technology
development and could undermine important research efforts in the state in
all areas biotechnology.

We appreciate the committee’s consideration of our concerns and encourage
committee members to oppose Senate Bill 570.

Respectfully submitted,

Sean Darragh
Executive Director, Food & Agriculture
Biotechnology Industry Organization

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 healthcare,
agricultural, industrial and environmental biotechnology products.