G. Enforcement Procedvxres. 
(Guidelines , Part IV) 
Implementation 2 md enforcement of the Guidelines is 
described on P . 39 of the DEIS. The two brief paragraphs on 
that page euid other short references to part IV of the Guidelines 
hardly deal with the difficult issues of ensuring compliance with 
the Guidelines. The statement on page 63 that "harmful effects... 
should be extremely unlikely given strict adherence to the NIH 
Guidelines" is unsupported by amy data or studies and assumes 
the Guidelines are fool-proof and will be perfectly followed. 
This type of analysis or lack thereof, cannot inform this type of 
legislatures or the public of actual problems and risks, nor aid in 
the decisionmaking process . 
The Guidelines place primary responsibility for their adherence 
with the "principal investigators." The concept of self-regulation 
whan dealing with potentially pathogenic agents is not at all 
acceptcdile. Due to a variety of causes including convenience, 
eagerness to get -apid rusults , or lack of consientiousness , the 
researcher's compliance may not be rigorous and therefor should be 
monitored by an outside agency. If violations of the Guidelines occur, 
a principle investigator concerned with retaining his grant might not 
be inclined to report the violation. We realize that am inspector 
camnot be in every laboratory where recombinamt research takes place. 
However, additional precautions are necessary to ensure responsibility 
on the part of principal researchers amd biohazards committees. 
In New York State, the Public Health Law, Article 32 requires. 
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Appendix K — 105 
