=======================Electronic Edition========================
RACHEL’S HAZARDOUS WASTE NEWS #78
—May 23, 1988—
News and resources for environmental justice.
——
Environmental Research Foundation
P.O. Box 5036, Annapolis, MD 21403
Fax (410) 263-8944; Internet: erf@igc.apc.org
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EPA TO PROPOSE RELAXED RULES ON CONTROL OF GENETIC EXPERIMENTS.
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
responsibilities.
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 themselves.
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, Ph.D.
Descriptor terms: epa; biotechnology; dna; doa; fda; regulation;
proposals; ronald evans;