posed actions in the Federal Register 
for comment. In addition, the Direc- 
tor's proposed decision, at his discre- 
tion, may be published in the Federal 
Register for 30 days of comment 
before final action is taken. The Direc- 
tor’s final decision, along with re- 
sponse to the comments, will be pub- 
lished in the Federal Register and 
the Recombinant DNA Technical Bul- 
letin. The RAC and IBC chairpersons 
will be notified of this decision. 
There is a group of lesser actions for 
which the RAC will advise the Direc- 
tor after a meeting announced as de- 
scribed above. These actions include 
all interpretations of determinations 
referred by ORDA, changes and as- 
signment of containment levels, ap- 
proval of large-scale experiments for 
rigorously characterized recombinant 
DNA where the absence of harmful 
genes has been established, and desig- 
nation of certain class 2 agents as class 
1 for purposes of the Guidelines. The 
Director’s -decision will be transmitted 
to the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin- 
And finally, there is a group of ad- 
ministrative and scientific functions in 
the Office of the Director that may be 
delegated to the Office of Recombin- 
ant DNA Activities (ORDA), involving 
implementation of the Guidelines and 
their interpretation. Again, decisions 
by the Director in these matters will 
be published in the Recombinant DNA 
Technical Bulletin, and notice will be 
given to the RAC and IBC. 
There was considerable Committee 
discussion on the standards to guide 
administrative discretion. It was 
agreed that the Guidelines should set 
forth a general standard. Accordingly, 
they now charge the Director to “with 
each proposed action, through appro- 
priate analysis and consultation, to de- 
termine that it complies with the 
Guidelines and presents no significant 
risk to health or the environment.” 
For a discussion of NIH efforts in risk 
assessment, see part III of this docu- 
ment and the Environmental Impact 
Assessment (Appendix I). 
The Guidelines now reflect these 
roles and relationships in detail and 
identify all of the responsibilities in 
cross-reference on the other sections 
of the Guidelines and to the Adminis- 
trative Practices Supplement. As indi- 
cated above, opportunities are afford- 
ed for public access and participation, 
with formal procedural requirements 
based on the significance of the discre- 
tionary authority. In light of these 
procedures, hearings by the Director’s 
Advisory Committee may be unneces- 
sary; but if circumstances warrant’, the 
committee can play an oversight role 
as it has done in the past. 
Recombinant Advisory Committee 
Membership. The correspondents and 
FEDERAL 
NOTICES 
witnesses at the September 15 hearing 
who commented on process consider- 
ations also expressed opinions on 
membership of the Recombinant DNA 
Advisory Committee (RAC). A number 
of recommendations were made con- 
cerning representation. Some wit- 
nesses at the September 15 hearing 
urged that representatives from the 
regulatory agencies, such as the Envi- 
ronmental Protection Agency, the 
Food and Drug Administration, and 
the Occupational Safety and Health 
Administration, have full voting mem- 
bership on the RAC. It was also sug- 
gested that a representative from the 
Council on Environmental Quality 
serve on the committee. The view was 
expressed that the representation of 
these agencies on the Federal Inter- 
agency Advisory Committee on Re- 
combinant DNA Research could not 
substitute for their full participation 
on the RAC. And it was suggested that 
representatives from the regulatory 
agencies constitute a subcommittee of 
the RAC for purposes of considering 
all future modifications of part IV. 
Some Federal agency commentators 
suggested that representatives from 
research agencies such as the National 
Science Foundation, the Department 
of Agriculture, and the Veterans Ad- 
ministration serve on the RAC, and 
perhaps be permitted to consider ex- 
ceptions to the prohibitions in the 
Guidelines. 
Several commentators recommended 
that representatives from unions and 
public interest groups serve on the 
committee. Quotas for membership 
were also suggested for public interest 
groups, unions, and nonprofessional 
laboratory workers. Public interest 
members might also be permitted to 
consider exemptions and exceptions to 
the prohibitions. 
There were a number of recommen- 
dations concerning professional and 
scientific expertise. One commentator 
advocated representation from 
“knowledgeable specialists in environ- 
mental processes and effects on eco- 
systems and their biota,” Other rec- 
ommended that the committee include 
scientists from Federal research agen- 
cies, scientists critical of the guide- 
lines, and experts in epidemiology, 
medical microbiology, and clinical in- 
fectious disease research. And finally, 
it was suggested that RAC be advisory 
to the Department rather than to 
NIH. 
Many of these concerns were raised 
at the December 1977 meeting of the 
Director’s Advisory Committee (DAC) 
by witnesses commenting on the re- 
vised Guidelines as proposed by the 
RAC. As. I stated in addressing those 
concerns in my July 28, Decision, I am 
acutely aware of the need for broad 
representation on the RAC, and this 
REGISTER, VOL 43, NO. 247— FRIDAY-, DECEMBER 
[ 20 ] 
60097 
was considered in the selection of new 
members. 
To ensure fairness, however, nomi- 
nations for openings on the RAC are 
publicly and widely solicited. In July 
1978 a notice was filed in the Federal 
Register requesting public recommen- 
dations for RAC membership. All 
nominations are considered in select- 
ing members of the committee. This 
open nomination process will be re- 
peated annually, and thus NIH will 
not be the only source of RAC nomi- 
nations. Further, nominations are 
being solicited from all agencies repre- 
sented on the Federal Interagency Ad- 
visory Committee. 
There was considerable discussion by 
the DHEW Committee about the 
membership of the RAC. The present 
RAC has 16 members, 2 of whom are 
lay persons. The DHEW Committee 
agreed that the composition should re- 
flect the requirements set for the IBCs 
at the local level. Thus, it is required 
that at least 20 percent of the RAC 
members shall be persons knowledge- 
able about such matters as applicable 
law, standards of professional conduct 
and practice, public and occupational 
health, and environmental safety. In 
addition, it is recommended that ofte 
member be a “nondoctoral” person 
from a laboratory technical staff. 
It was also agreed that the scientific 
representation on the committee 
should be broadly based to include 
persons knowledgeable in recombinant 
DNA technology and biological safety, 
but also with expertise in the broader 
disciplines of biology and medicine— 
i.e., microbiology, molecular biology, 
botany, ecology, virology, genetics, in- 
fectious disease, plant pathology, and 
epidemiology. 
In view of the expanding role and re- 
sponsibilities of the RAC, it was 
though appropriate to augment the 
expertise and representation. Under a 
new chapter, the RAC will be expand- 
ed to 20 members. 
In addition, all Federal agencies rep- 
resented on the Federal Interagency 
Advisory Committee will have nonvot- 
ing members on the RAC. (At present, 
some research agencies already have 
liaison members, such as the National 
Science Foundation and the Depart- 
ment of Agriculture.) These repre- 
sentatives will be nonvoting because of 
the large number of Federal agencies 
involved, but they will be participating 
members encouraged and enabled to 
present their agencies’ concerns on sci- 
entific and other issues. 
All members of the RAC may par- 
ticipate on the several subcommittees 
of the full committee. Thus, there is 
clearly no need to mandate the nature, 
structure, qr function of subcommit- 
tees created by the chairperson in con- 
sultation with committee members. Fi- 
nally, the RAC is advisory to the Sec- 
22, 1978 
