22 
The Guidelines were developed because of concern about the possible 
effects of recombinant DNA research on the environment. Necessarily, 
therefore, this development included a review of the environmental 
impact of the research. For example, the objectives of recombinant 
DNA research were considered and the potential hazards and risks 
analyzed. Possible alternative approaches to the objectives were 
thoroughly explored, to maximize safety and minimize potential risks. 
And a comprehensive review structure to ensure safety has been 
created. Moreover, in developing the Guidelines, the NIH conscien- 
tiously attempted to provide full information to the public and to 
solicit the public's views. 
Section IV-B of the Guidelines defines the roles and responsibilities 
of institutions in which recombinant DNA methodology is used. The 
basic mechanism for ensuring local compliance is the institutional 
biohazards committee. Sections V and VIII of Appendix C of the EIS 
give additional administrative details concerning these committees, 
including the requirement that the NIH Office of Recombinant DNA 
Activities (ORDA) be informed of their establishment and composi- 
tion. Institutional biohazards committees responsible for recombinant 
DNA activities (but not necessarily exclusively) have been established 
in a number of institutions. A listing of these institutions, based on 
our current information (January 19, 1977), is included in Appendix F 
to the EIS. 
As explained in Appendix C (Section V and Appendix A) of the EIS, 
the Guidelines (Section IV) require execution of a document entitled 
"Memorandum of Understanding and Agreement" (MUA) by each 
investigator and his institution. The MUA must be submitted with 
all new and renewal applications for grants. 
Shortly after the Guidelines were issued, submission of a MUA 
was required for all ongoing, funded research grants supported by 
NIH if recombinant DNA technology was utilized. A list of funded 
projects for which MUAs have been received as of January 1, 1977, 
is included in Appendix G to the EIS. Readers must realize that the 
dollar amounts of each listed project cover the entire project, including 
activities unrelated to recombinant DNA technology and operating 
costs for laboratory buildings and facilities. It is not possible at 
present to calculate what portion of funds obligated for each project 
is related to recombinant DNA activities. In most instances such 
activities will represent only one of many procedures used, and will 
constitute a relatively small portion of the total costs. 
