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May 1, 2000


Biotech oversight checkpoints



C.S. Prakash

The Washington Times, May 1, 20000

A long-awaited report by the National Research Council
should reassure consumers that foods derived from
biotechnology are thoroughly tested and safe. The council
said there is no evidence genetically improved foods pose
any more risk to public health or the environment than any
other food. In fact, crops modified to control insects
without chemical pesticides probably pose less risk, the
council said.

Most of the regulatory changes recommended by the
council have already been implemented, such as improved
allergenicity testing, programs to prevent insects from
developing resistance to crops and follow-up studies to see
if Monarch butterflies, which were adversely affected in the
laboratory, could be harmed in the field. Several field
studies last year showed the risk to Monarchs is very low.

One statement in the council's report particularly
resonates. "Public acceptance of these foods ultimately
depends on the credibility of the testing and regulatory
process." The council urged regulatory agencies to post
detailed information on websites so the public could more
readily understand the process. This is far overdue. If the
public understood how thoroughly biotech products are tested
and scrutinized, much of the uneasiness surrounding biotech
would go away.

*Three federal agencies involved: Regulatory
oversight of biotechnology is constant, and there are at
least nine times in which a formal decision to move forward
is required. This means that a number of agencies and people
within those agencies have an opportunity to raise
objections, ask for more information and potentially halt a
project if their concerns are not satisfied. In most of
these formal steps, public comment is invited and

The first opportunity comes almost immediately after a
scientist discovers a potentially marketable product
concept. Following guidelines developed by the National
Institutes of Health, developers empanel a Biosafety
Committee made up of employees and members of the general
public. This group considers the potential risks of the
concept and can recommend that it go forward or be canceled.

The U.S. Department of Agriculture has four formal
opportunities to advance or halt a product. First, USDA must
determine if existing research facilities are adequate for
continued development of the product. The developer must
receive USDA approval to conduct field trials. USDA must
give authority for the developer to ship seeds from a
greenhouse to field trial sites. And, most important, USDA
spends nearly a year reviewing a full package of field
trials and studies.

If the new plant performs a function traditionally
performed by a chemical pesticide (insect-protected corn or
cotton) the Environmental Protection Agency is involved in
three formal steps. EPA must grant an experimental use
permit if the developer wants to test 10 acres or more. EPA
must also decide whether limits (tolerances) should be set
on the amount of pest-control protein in foods derived from
the crop. And, finally, EPA typically spends 18 months
reviewing a host of environmental and toxicological studies.

The Food and Drug Administration is involved in the
process almost from the beginning and is the primary
overseer of food safety. FDA meets with the developer early
in the process and provides guidelines on what studies FDA
considers appropriate to ensure food and feed safety. The
interactive involvement between FDA and the developer spans
several years. Furthermore, FDA has authority, under the
Food, Drug and Cosmetic Act, to immediately remove from the
market any food the agency deems unsafe.

*A thorough examination: During this process, the
three federal agencies examine health and environmental
safety. USDA, in years of field trials, examines many
parameters of the biotech crop to see if inserting a new
gene caused the plant to differ from its conventionally bred
counterpart. The field trials also tell USDA if the crop is
having any effect on non-target species. USDA also is
responsible for ensuring that the plant will not become or
create a weedy pest.

EPA reviews toxicological studies to ensure the new
crop does not harm wildlife or humans. High doses of the new
protein are fed to rodents, beneficial insects, birds and
fish. Digestibility studies and other data determine if the
inserted material is an allergen or creates an allergen when
inside the plant.

FDA compares every significant parameter of the
improved plant with its traditional counterpart. Agronomic
and physiological characteristics are compared, as are
nutritional components (protein, starch, sugar, fat, amino
acids, etc.) Any unexpected changes lead to further study.
When no changes are seen, FDA can conclude with great
assurance that the biotech crop is substantially equivalent
to and hence "as safe as" the conventional crop.

The review process for biotechnology is constant,
thorough and logical. It just needs to be better understood.