Introduction Guide to Biotechnology - Biomolecular Engineering Lab

Regulation of Crop Biotechnology
Since combining specific genes from donor and host
plants does not alter the basic nature of the host plant,
the result of genetic modification is predictable and can
be carefully controlled. As with any new variety of food,
the developers test extensively for safety, quality and
other factors.
U.S. regulatory policy for biotechnology products was established
in 1986 with the publication by the White House
Office of Science and Technology Policy of the “Coordinated
Framework.” This framework builds on the work of
international expert bodies (such as the Organization for
Economic Cooperation and Development [OECD] and the
U.S. National Academy of Sciences). The responsibilities
of regulatory agencies are clarified, linked to the laws they
administer and coordinated with other agencies that have
potentially overlapping responsibilities.
The U.S. Food and Drug Administration (FDA) approves
the safety of all foods and new food ingredients. In addition,
all producers are required to ensure the safety and
quality of anything they introduce into the food supply.
The FDA requires strict premarket testing and regulatory
oversight of genetic modifications that significantly alter
the nutritional value of the host food, use genetic material
from outside the traditional food supply or use known
allergens.
The FDA also requires labeling of any food product produced
through biotechnology that significantly alters the
host food’s nutritional value or uses material from a known
allergen. For example, any product that uses a gene from
a peanut, which is a potential allergen, would be subject to
testing and labeling requirements. The FDA also has the
authority to order unsafe products off the market.
The USDA and the U.S. Environmental Protection Agency
(EPA) impose safety requirements and/or performance
standards on the development of pesticides, herbicides and
genetically enhanced test crops. The USDA regulates to
ensure that crop varieties improved through biotechnology
are safe for the agricultural environment. Rigorous assessments
are conducted concerning the derivation of the
new varieties and their performance under contained and
controlled field trials.
The EPA also coordinates with the USDA and FDA, using
its own statutes to regulate the growing of plants with
pest-protection characteristics. The EPA sets allowable
food residue tolerance levels for any novel compounds
that might be used.
Forest Biotechnology
Throughout the world, wood provides us with fuel,
construction materials and paper, and its supplies are
dwindling rapidly. Wood products are currently a $400 billion
global industry, employing 3 million people. Demand
for wood products is expected to increase, even as major
economies, such as Europe and Japan, are unable to grow
enough trees to meet their current demand.
Increasing Productivity
We are using biotechnology to create disease- and
insect-resistant trees and to increase their growth
rates.
We are using biotechnology to create disease- and insectresistant
trees and to increase their growth rates. Scientists
are also learning how to use biotechnology to improve
the efficiency with which trees convert solar energy into
plant material and to shunt more of that energy into wood
production and less into pollen, flowers or seeds. All of these
methods of increasing productivity should decrease the pressure
on natural forests.
However, developing trees through the use of biotechnology
is a lengthy undertaking because trees take a long time to
grow. So, researchers are looking to other methods for increasing
productivity. For example, they are using a biotechnology
process in a fungus to fight diseases that infect trees
and are working on improving the microorganisms that
live on tree roots and provide trees with nutrients, much as
nitrogen-fixing bacteria increase the nutrients available to
soybeans and alfalfa. In addition, biopesticides have also been
used extensively to control forest pests, and we expect progress
in insect cell culture to boost the number of biocontrol
agents available for forest insect control.
Environmental Benefits
Perhaps a more important economic role for biotechnology
in this industry will be found in its changing
the way we convert trees to useful products. Extensive
research is being conducted to increase a tree’s amount
of cellulose, the raw material for papermaking, and to
decrease the amount of lignin, a tough molecule that
must be removed in papermaking.
Traditionally, removing lignin from trees has required
harsh chemicals and high energy costs, so changing the
cellulose:lignin ratio genetically has important environmental
implications, as does increasing the growth rate
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Guide to Biotechnology n Biotechnology Industry Organization