Attachment IV - Page 5 
enclosed), and FIFRA section 5, which concerns the experimental 
use of pesticides. Also enclosed is an article from the 
"Recombinant-DNA Technical Bulletin" that summarizes these 
aspects of EPA's program plan for registering engineered 
microbial pesticides. 
3. What is HHS's projection for FY '84 and FY '85 for 
the number of applications it anticipates receiving 
for field scale releases? For commercial releases? 
EPA has not been informed of any Health and Human Services 
(HHS) projections for intentional release applications or commer- 
cial releases. For more information on HHS activities you 
may want to contact: Dr. William J. Gartland, Jr. at the 
National Institutes of Health: 496-6051. 
For your information, concerning projected workloads, 
OPP has already received between 15 and 20 inquiries from a 
number of prospective applicants, including both large pesticide 
companies and new companies set up specifically to produce 
genetically engineering biological products. To date there 
are no formal applications for the registration or experimental 
use of an engineered biological pesticide. However the NIH-RAC 
recently reviewed and approved a research proposal for the 
field test of an engineered microbial. This proposal involves 
the field test of a natural plant-dwelling bacterium genetically 
manipulated to remove its frost-promoting properties. 
OTS has thus far received several inquiries from prospective 
PMN submitters under TSCA. OTS estimates that it will receive 
fewer than 10 submissions in FY '85. 
4. How does EPA plan to coordinate its activities with 
other regulatory and R&D programs in EPA? With the 
U.S. Department of Agriculture? With the National 
Institutes of Health? 
The Federal Register notice (discussed in response to 
question one) will delineate the regulatory responsibilities 
of EPA's OPP and OTS as well as mechanisms for coordination 
with other EPA offices and other agencies such as USDA and 
NIH. EPA will also be involved in related activities such as 
participation on NIH's RAC, the Cabinet Council Working Group 
on Biotechnology, and the OPP Science Advisory Panel (SAP) 
subgroup's review of pesticide issues. 
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