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#78 - EPA To Propose Relaxed Rules On Control Of Genetic Experiments, 22-May-1988

The U.S. Environmental Protection Agency (EPA) next month will propose
relaxed controls on field tests of genetically altered creatures.
Genetic alteration of living things--a technique sometimes called gene
splicing, or genetic engineering, or recombinant DNA, and known
generally as biotechnology--gives new characteristics to the altered
creatures. The new characteristics are permanent and are passed on to
successive generations. The alterations are intended to make the
creatures more useful to humans (and thereby more profitable to the
people doing the altering). The U.S. Patent Office ruled last year that
genetically altered creatures can be patented, thus opening the way for
large profits to be gained from biotechnology. The first patent on a
genetically-altered creature (a mouse) was awarded to Harvard
University earlier this year.

The potential benefits from biotechnology appear to be large. But the
potential for unanticipated harm may also be large. Genetic mechanisms
are complex, so it is difficult to gain confidence that one can predict
all the changes that will occur in a living creature when its genetic
structure is altered.

Since most of today's environmental problems have been caused by
unexpected side-effects of new technologies, people are understandably
concerned that biotechnology should be carefully controlled and that
genetically-altered creatures should not be released into the
environment before their safety has been established.

The Reagan administration two years ago set up a framework for control
of biotechnology. The Agriculture Department has responsibility for
altered plants and animals on farms; the Food and Drug Administration
regulates creatures intended for pharmaceutical use; and the EPA is
responsible for bacteria and viruses intended for use as pesticides,
fertilizers, and industrial products. These agencies have overlapping

Next month the EPA will propose to relax its rules governing small-
scale field experiments in which genetically-altered creatures are
released into the environment to see what effects they may have. To
date, four such field trials have been conducted and a fifth is nearing
completion now. The proposed rules would relax control over experiments
in which genes were transplanted from one microbe to another very
similar microbe. The relaxation of control would not affect experiments
involving transplant of a gene from one species to another, or
experiments where hazards were anticipated.

Under the EPA's proposal, companies conducting outdoor experiments in
which no hazard is expected would have to file much reduced paper work
with the EPA; in some cases, the EPA would not have to be notified of
experiments at all.

Under the proposed new rules, authority for reviewing and approving
small field trials would be transferred to permanent committees of
experts established by biotechnology companies and universities. In
other words, the experimenters would be given permission to regulate

The EPA says it is proposing the rule change because a consensus is
developing among practitioners that some classes of altered creatures
are not as hazardous as federal regulators had initially feared.
Critics of the proposed rule change point out that a handful of field
trials do not provide a scientific basis for changing the rules.
Furthermore, asking the companies to regulate their own activities puts
them in a conflict of interest position. There are enormous profits to
be made from biotechnology and it is a fiercely competitive business.
Pressure to cut corners is always present, and the EPA seems to be
inviting trouble by relaxing the rules. For further information,
contact Ronald Evans, Biotechnology Project Manager, Chemical Control
Division, Toxic Substances Control Office, U.S. EPA, 401 M Street, SW,
Washington, DC 20460; phone (202) 3823856.

--Peter Montague



The air in offices, where white collar workers spend their lives, is
increasingly contaminated with molds, bacteria, chemical fumes and
other contaminants. Four factors are making the situation worse:
efforts to reduce energy consumption, the tendency to squeeze more
people into less space, sloppy maintenance, and increasing reliance on
toxic chemicals in manufacture of office supplies and equipment.

Dr. Alfred Munser, a director of the American Lung Association, says,
"In my practise [as director of critical care at Washington Adventist
Hospital in Takoma Park, MD], I see an increasing number of people with
vague respiratory problems that are quite bothersome. You can't really
pin the problems on anything specific, but looking closely at the
history of these people, you get the feeling that the symptoms are
associated with something at work. Very often ventilation systems are
not cleaned out. And all sorts of things can grow in those systems."

People on the breathing end of those ventilation systems tend to suffer
from more than their share of headaches, sore throats, eye irritations,
colds, allergies, and influenza, says Dr. Munser.

Since the energy crisis a decade ago, landlords have been reducing
their heating and air condition bills by installing heavier insulation
and by reducing fresh air intake; fresh air has to be heated or cooled
to the proper temperature, at considerable expense. Pumping recycled
air through a building's ventilation ducts is far cheaper.

Vapors from copying machines and carpets, asbestos fibers, bacteria and
viruses, hazardous dust, carbon monoxide from underground parking
garages--all contribute to the problem.

Because modern buildings lack windows that employees can open to let in
fresh air, everyone is becoming reliant upon mechanical ventilation
systems. Yet in 35% of 240 buildings inspected over the past five years
by ACVA Atlantic (a company in Fairfax, VA, that investigates and
remedies indoor air pollution problems), the fresh air intakes were
sealed off entirely. "That's just ignorance," says Gray Robertson,
president of ACVA. "The building engineers never saw the absenteeism
records in the personnel department and no one made the connection
between polluted air and all the headaches, coughs, and sickness."

Poor indoor air quality makes many U.S. white collar workers miserable,
and it costs an estimated $2 to $3 billion each year in extra sick days
and medical pay.

--Peter Montague


Descriptor terms: epa; biotechnology; dna; fda; usda; regulation;
ronald evans; indoor air pollution; air pollution; air quality; alfred
munser; american lung association; respiratory disease; lung disease;
occupational safety and health; acva atlantic inc; gray robertson;