EPA Regulation of Transgenic Plants
James E. Thornton
jetsioux at clark.net
Fri Aug 25 19:39:18 EST 1995
EPA, late in 1994, proposed that any and all transgenic
plants containing genes that either confer pest or
disease resistance be classified as "plant pesticides"
and therefore be subject to FIFRA regulation--which,
plants containing similar genes obtained through
traditional breeding methods, would not be, nor never
have been, subject to. Also, any inclusion of such
transgenic plants under EPA/FIFRA regulation would almost
automatically mean that all 50 states would require
similar regulation at their level as well. Therefore, any
company pursuing such transformations, which is planning
eventually to market such new cultivars, would be faced
with obtaining the approval of upwards to 52 individual
government regulator agencies. If you are a Monsanto or
similar large biotech or ag/chemical company who already
has a large in-place regulatory staff, you probably
couldn't care less--especially if you thought such new
regulation might stop a lot of smaller companies from
competing with you (or force them to sell or license
their technology to you, since they could not afford such
high regulatory costs).
EPA will submit their final recommendations to its
Science Advisory Committee probably in December, followed
shortly thereafter by submission of their proposed rule
to OMB for final approval.
Congress, in meantime, will likely debate the matter
shortly following the Labor Day recess when they take up
EPA's appropriation as a part of the VA-HUD, Independent
Agency Appropriation bill for next fiscal year.
USDA has taken strong exception to EPA's proposed rule
making in this case and hopefully will continue to do so.
I suggest any of you who share concern about this absurd
intrusion by EPA into this regulatory area contact their
Congressional delegation and the White House very soon. I
suggest you ask them to support the House passed "Walsh"
amendment to the VA-HUD Independent Agency Appropriation
Bill, which if adopted by the Senate, and/or in
Conference, would prohibit EPA from using any of its
funds to implement such a regulation. Current
governmental regulations and procedures now in place are
generally more than adequate to protect the public
regarding such matters. If there are problems of
particular concern which differ substantially from those
now applicable to plants transformed by traditional
methods, then lets address those as such and not bring
the whole plant world into EPA's regulatory web, thereby
adding tremendous cost, time and loss of technological
advantage to this nation.
This amendment, in my judgement, is an extremely serious
threat to the future of plant biotechnology--and as I
stated earlier--lethal to small biotech companies who are
in that business.
Demeter BioTechnologies Ltd
jetsioux at clark.net
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