Guidelines should be modified when it makes sense to do so. He stated that EPA would still have to be notified and/or 
review any deliberate release experiments; and that, therefore, any such experiment would still be regulated in terms of 
product 
Dr. Go desman then made the following motion: 
That the RAC accept the proposal to amend Section 
m-A-2 of the Guidelines to read: 
Deliberate release into the environment of any organism 
containing recombinant DNA, except 
a. Certain plants as described in Appendix L. 
"b. Deletion derivatives not otherwise covered by these 
Guidelines. 
'c. Organisms covered in exemption IU-D-2.” 
After Dr. Johnson seconded the motion, the Chair called for further discussion. 
Dr. Go desman replied to Dr. Sharpies with the statement that she fell that RACs looking at the recombinant DNA 
process was appropriate. However, it is important that the RAC not give the impression that an experiment is 
necessarily "special" just because recombinant DNA was used. RAC will lose scientific credibility if it maintains 'that 
because recombinant DNA was passed magically over an organism that it does something special to it.' She underlined 
the fact that deletions and rearrangements take place in nature; just because recombinant DNA techniques are used to 
elicit these same genetic changes, RAC should not be reviewing them as unique and special cases. 
Dr. Goaesman said she was pleased that other government agencies will be reviewing those organisms which need to be 
looked at for environmental effects. However, on the other hand, she hoped that they won't review them in extra detail 
just because recombinant DNA was used to make them. 
Dr. Korwek noted that the current NTH Guidelines sate that if a deliberate release experiment is submitted for review to 
another Federal agency, then the NIH Office of Recombinant DNA Activities may "determine that such review serves 
the same purpose, and based on that determination, notify the submitter that no RAC review will take place, no NIH 
approval is necessary, and the experiment may proceed upon approval from the other Federal agency." For such 
experiments, adoption of the Goaesman proposal could be viewed as RAC only giving up the right of first review. He 
asked if RAC still wanted to review those experiments that would not get review by another agency. 
Dr. Cohen cited the example of using a chemical agent to make a deletion in a microorganism and asked what EPA 
constraints a researcher would be under to field test such an organism. 
Dr. Nlilewski stated that EPA's policy is to look at all biotechnology products that are microorganisms which fall under 
the EPA's toxics and pesticide statutes. Because these statutes are product-oriented, the EPA would review organisms 
generated by chemical mutation. UV-irradiation. cell fusion, or biotechnology including recombinant DNA. Under the 
toxics statutes, the EPA only covers research that is subsidized by industry-; under the pesticide statutes coverage is 
broader because EPA looks for the effects an organism would have on the environment and has little interest in the w-ay 
the organism was generated. The hypothetical research as propounded by Dr. Cohen would have to get approval for 
small-scale Geld testing if it fell under the Federal Insecticide, Fungicide and Rodenticide Act whether the investigator 
utilized recombinant DNA, chemical mutagenesis, or UV-mutagenesis to produce the test organism. 
Dr. Roberts said that he felt RACs attention should be saved for organisms which were developed using recombinant 
DNA that were unique and not simply engineered copies of organisms that could be found in nature. Dr. Clowes 
agreed. 
Dr. Gouesman stated she fell that RAC should not continue jurisdiction over the types of organisms that would be 
removed from coverage by the NIH Guidelines under her proposal because the same organisms could be produced using 
oadiuonal genetic techniques and that merely the use of recombinant DNA technology to produce them does not make 
them unique. 
Recombinant DNA Research, Volume 1 1 
(93] 
