18 
lines are a reasonable mod'el upon which the Secretary could base 
administrative regulations. In particular, the current practice in the 
NIH Guidelines of delegating to local biohazards committees most of 
the responsibility for the inspection of facilities and the approval 
of the specific safety requirements appropriate to each pr-ojebt br 
activity is an effective.' and relatively inexpensive administrative 
mechanism. Furthermore, most institutions where recombinant DNA 
activities are or will be conducted already have a biohazards commit- 
tee in place. 
The regulations under this section should, therefore^ include guide- 
lines respecting the membership of biohazards committees including 
the number of committee members, the method by which members are 
selected and the r inclusion of public members. These guidelines should 
also address potential problems of conflict of interest between bio- 
hazards committee members and activities in which they have a direct 
or financial interest. 
The committee , expects that the NIH Eecombinant DNA Mole- 
cules Program' Advisory Committee will continue its current func- 
tion of continually examining and updating the content of sections 
II and III of the guidelines, ’of approving new safe hosts and vectors 
and generally providing technical advice on policy matters. The regu- 
lations under this section should, however, include provisions re- 
specting the diversity of the membership of this committee in order 
to guarantee representation on the cbmmittee of; the full range of 
technical expertise needed to properly evaluate potential hazards 
posed by recombinant DNA activities and to design appropriate 
safety standards. Since the perspective of non-scientists has been 
found to be of value on the current Eecombinant Advisory Commit- 
tee, such regulations should also require that some members be ap- 
pointed from non-6cientific disciplines. 
Since the individuals working directly on recombinant DNA ac- 
tivities would generally be at the greatest risk, should any hazards 
be presented by the conduct of such activities,! the committee expects 
the Secretory to include, in the regulations promulgated under this 
subsection provisions to reduce the risk of injury to such individuals 
as much as possible. Such requirements might include laboratory 
safety training courses or examinations, information to be given to 
workers cdncerning the nature of the risks presented, monitoring for 
indicators of possible infection, where appropriate, and guidelines 
concerning the type and frequency of medical examinations. Such 
personnel safety provisions would be particularly important in the 
case of workers involved in manufacturing of mass production pro- 
cedures who may not be trained scientists or research technicians. 
It is the committee’s intent that the administrative regulations 
address the problem of the protection of confidentiality of propriety 
-or other data where appropriate. ! In order to make determinations 
as to the proper safeguards appropriate to each recombinant DNA 
activity in itk jurisdiction, local biohazards committees may at times 
have access to information in this category. Members of local commit- 
tees who are 'carrying out' administrative duties under this act, would 
be doing so as agents of the Secretary and thus subject to section 1905, 
title 18, United States Codfe, making it a criminal offense for Federal 
employee^ to disclose tfade secrets. 
[Appendix B — 148 J 
