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]]]]]] HOW GENETIC ENGINEERING GOT A BAD NAME [[[[[[[[[
by Donald L. Ritter (2/27/1989)
Reprinted by permission from IMPRIMIS, February 1989, the
monthly journal of Hillsdale College, Michigan, a college that
does not accept government money. Donald Ritter, A METALLURGIST,
is the only scientist in the US House of Lords (R-Pa). He uses
reason instead of emotions and is thus an utter misfit in his
environment. [Sysop's note.]
[Kindly uploaded by Freeman 10602PANC]
There seems to be a serious condition afflicting America today
which I and others have labeled ``chemophobia.'' It is often
communicated through misinformation, sensationalism and political
activism, but its real source is a mix of utopianism, fear of the
unknown, and hostility towards science and the established order
of society itself. It feeds on scientific illiteracy, is
contagious, and generally extends to all Western industrial
nations.
FEAR AND IGNORANCE
To those with healthy, positive views of who we are as a
nation and as a people, science is an invaluable tool for
protecting and enhancing life; but to those in the grip of
chemophobia, science seems to be an instrument of environmental
and biological degradation born mostly of corporate greed. The
media, seeking subscriber dependence, with most reporters lacking
science backgrounds, seems determined to advance this dark view.
Since we depend on television news and the national and local
press for nearly all of our information, it has had a devastating
impact. Armies of activists, lawyers and white knight
politicians join the media in claiming to protect our interests
against alleged impending disaster.
Meanwhile, our educational system continues to do a poor job
of teaching the basic biology, chemistry, math, and physics
skills which are essential to an understanding of science and
technology in the world.
Most Americans are concerned about pesticides, air pollutants
and the like. But they are unfamiliar with crucial facts about
the hazards of daily life, like the fact that the cancer hazards
of most ``harmful substances'' regulated by the government are
literally outweighed by the dangers of chemical carcinogens in
the ``natural'' food we eat every day.
How then can we expect American people to realize that not all
man-made chemicals are dangerous, and, indeed, that most are
actually ``the grease for the gears of the modern technological
society?'' Furthermore, how can we expect them to appreciate the
progress engendered by the democratic capitalistic experience in
which scientific innovation plays such an important role?
One bitter fruit of our ignorance -- and resulting fear -- is
the current attack on biotechnology, especially genetic
engineering. As a result, the biotechnology industry, which has
grown rapidly in the last few years and exhibits great promise,
is on the brink of stalling. A stampede of rules and regulations
could keep us held back in the laboratory, when we should be out
in the marketplace. The good news is that countless laboratory
and field tests are proving that biotechnology can work. In
1986, the widely publicized ``Frostban'' experiment in California
demonstrated how engineered bacteria can safely be sprayed on
strawberry plants to help them resist frost. In the long run,
successful products like Frostban can help us avoid millions of
dollars in damage for all kinds of crops.
INNOVATION STALLED
But if that seems like a reason to celebrate, the
biotechnology industry isn't doing cartwheels. The company that
makes Frostban, Advanced General Sciences (AGS), was so battered
by a long and arduous regulatory struggle with the federal and
state governments over testing that it had to merge with another
company just to stay afloat. In January of 1988, the New York
Times reported that other companies interested in developing
genetically-engineered products are standing on the sidelines.
Fewer than ten companies are now active in that field -- and even
if some are moving forward with field tests, they all are waiting
for clearer signals form the regulatory agencies. The future,
quite simply, looks uncertain.
Few laymen have the necessary knowledge to grasp
biotechnology's potential, so it is no wonder that the critics of
genetic engineering have been spectacularly successful in
creating a sense of fear. Fear usually emerges from ignorance,
and this is nowhere more clear than in biotechnology. Public
anxiety over perceived environmental risks is outweighing sound
scientific analysis and, when mirrored in public policy, is a
serious obstacle to scientific innovation and the necessity to
rapidly commercialize scientific advances.
At first the biotechnology community was self-regulating. The
Asilomar Conference of 1975 established guidelines for
recombinant DNA research in laboratories receiving federal
funding. Since 1974, the Recombinant DNA Advisory Committee
(RAC) of the National Institutes of Health (NIH) has relaxed the
guidelines twice, because scientists have been able to safely
manage the risks associated with DNA research.
Prior to the 1980s, NIH took the position that no federal
agency had the authority to regulate private biotechnology
research, so the federal government was not involved in any
further regulatory activity. The biotechnology industry began to
grow, largely in the laboratory, and it complied voluntarily with
RAC guidelines. During this time, proponents of regulation tried
to convince Congress to make compliance mandatory, but their
attempts were unsuccessful.
Thus, in the early part of this decade, many ambitious
entrepreneurs entered the biotechnology field. Over two-thirds
of all biotechnology firms have been in business for less than 10
years. These entrepreneurs can revolutionize the way we live: by
working to find treatments for diabetes, cancer, and AIDS; by
improving food production with stronger animals and hardier,
disease-resistant plants; and by creating microbial organisms to
control insects and toxic wastes.
They exhibit a refreshing ``can-do'' attitude. So it is not
surprising that they want to take their products out of the realm
of the laboratory and into the real world. They desire to create
useful products and to make profits, but also to meet global
challenges of hunger, disease, and waste disposal.
In the last few years, when the biotechnology industry was
prepared to test its new products in the field, it faced a
national uproar over whether genetically engineered organisms
should be ``released'' into the environment. In the mid-to-late
1980s, it is understandable that the focus of legislative and
regulatory attention had to shift: Guidelines for mere laboratory
research -- which were not appropriate any longer -- had to be
replaced. But this shift was dramatically affected by critics
who dominated the public debate, casting a cloak of suspicion
over all biotechnology innovation.
Jeremy Rifkin is biotechnology's most outspoken critic. He
was quoted in the Washington Post in early 1988 as saying that
genetic engineering is ``so powerful and so inherently
wrongheaded that `in the mere act of using it, we have the
potential to do irreparable psychological, environmental, moral
and social harm to ourselves and the world.' ''
It hardly mattered amidst such widely-believed but unwarranted
charges that the scientific community has overwhelmingly decided
that biotechnology is safe. The National Academy of Sciences
published a report in 1988 on the possible environmental risks
associated with the deliberate release of genetically engineered
organisms, concluding that there ``is no evidence that unique
hazards exist in either the use of recombinant DNA techniques or
in the movement of genes between unrelated organisms.'' Some
significant field tests have shown that microorganisms aren't
posing any hazards. But no one has stepped forward to tell this
to the American people. News, especially good news that isn't
sensational, just doesn't make the front page, so biotechnology's
opponents continue to file lawsuits and grab publicity.
REGULATORY AGENCY OVERLAP
Fortunately, the study group which President Reagan
established in 1984 to review biotechnology regulation opted for
a balanced approach. It decided to create ``a coordinated and
sensible review process.'' This process, it was hoped, would
``minimize the uncertainties and inefficiencies that can stifle
innovation and impair the competitiveness of U.S. [biotechnology]
industry,'' while simultaneously weighing risks. The result was
a document called the ``Coordinated Framework for Regulation of
Biotechnology.'' Whether it is genuinely coordinated, however,
remains to be seen.
The ``Framework'' states quite correctly that existing
regulations are adequate, but in its preamble, it lists five
separate federal agencies which have statutory authority over all
biotechnology research and development: the National Institutes
of Health (NIH); the United States Department of Agriculture
(USDA); the Environmental Protection Agency (EPA); the Food and
Drug Administration (FDA); and the Occupational Health and Safety
Administration (OSHA). There is considerable overlap of
authority between these watchdog agencies, and to make matters
worse, the preamble leaves crucial definitions like ``release
into the environment'' up to subsequent determination.
Immediate problems have resulted since regulators have begun
to apply laws to microorganisms designed to regulate plants,
pesticides and foods. Companies desiring to comply with
regulations are unsure of how to do so, or they receive
conflicting information from the government. And the result is
too often a loud hue and cry in the media. We can return to the
example of the AGS product, Frostban, whose concept was simple:
Researchers started with two bacteria called pseudomonas [P.
syringae and P. fluorescens], which have literally been with us
since the beginning of time. [Pseudomonas act as nucleators for
the condensation of water and the formation of ice crystals.]
They altered one single gene, leaving the microorganism unable to
form ice at low temperatures [just barely below the freezing
point].
MOONSUITING THE BIOTECHNOLOGY INDUSTRY
AGS's first rooftop test of Frostban complied with NIH
guidelines for a deliberate release. Those were the first such
guidelines available. But because the company hadn't obtained
the EPA's approval, the EPA fined the company and delayed further
testing. The EPA finally approved outdoor tests. Local
regulators thereupon jumped into the act and required testers to
wear moonsuits -- yes, moonsuits like astronauts wear, complete
with helmet, gloves, and breathing pack -- and required them to
erect a fence around the test site!
According to a reporter's account of the second Frostban test,
a dozen people swarmed over a strawberry patch the size of two
tennis courts, distributing hundreds of petri dishes and setting
up equipment on steel towers. (The drama mounted when a vandal
trespassed upon the plot and uprooted some of the strawberry
plants. An environmental protester stood before television
cameras and praised this act.) Then, an AGS scientist dressed in
a moonsuit took up a garden sprayer; simultaneously, the EPA
official present at the site signaled for some 60-odd vacuum
pumps to begin to suck up air samples. And the intrepid
scientist, probably bewildered by all the attention, began to
spray.
I can't imagine a scene more carefully crafted to frighten the
biotechnology industry into abandoning its plans to test new
products. Nor is this experience unique. The statutes
themselves create ample opportunities for confusion. Let us
assume that a company desires to genetically engineer a plant
that will resist diseases. Well, under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), the EPA regulates plant
pests. So both agencies would have jurisdiction to review the
application. The company would face at least two standards of
review and chances are other agencies would also claim
jurisdiction.
Experience with the current regulatory system suggests that it
is time for reform. Regulatory uncertainty is quite simply
eroding America's lead in biotechnology. Other nations are
moving more aggressively into commercial products and processes.
We need to streamline the cumbersome bureaucratic tangle that
arose under the so-called ``Coordinated Framework,'' in order to
bring more certainty to the process, and, above all, to allow
American biotechnology companies to confront global competition
head-on.
New companies, new jobs, and indeed whole new technologies and
new industries are within our grasp. Great goals of human
endeavor are at stake. We must create a climate where
biotechnology can help us reach them.
------------------------------------
Don Ritter is currently serving his sixth term in the U.S.
House of Representatives for the 15th district of Pennsylvania.
One of a handful of House members with a technological background
and the only one at the doctoral level, he earned his M.A. and
Sc.D. degrees from the Massachusetts Institute of Technology in
metallurgy. Before his election to Congress, he taught and was a
research administrator at Lehigh University. He has also served
as a consultant to industry in the fields of materials and
manufacturing. In the House, Dr. Ritter serves on the House
Energy and Commerce and the Science, Space and Technology
Committees. He also chairs the Republican Task Force on High
Technology and Competitiveness.
------------------------------------
[The Following is not part of the original article.]
`AIDS and Frostban', Access to Energy, June 1987, p. 3.
Campbell, Gerald R. Biotechnology: An Introduction. Summit, NJ:
American Council on Science and Health, January 1988.
* * *
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