EPA Proposed Regulation of Transgenic Plants

[James E. Thornton]

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.

Jim Thornton
Vice President
Demeter BioTechnologies Ltd
jetsioux at clark.net