60094 
NOTICES 
It should be emphasized that while 
the delegation to the IBCs permits ini- 
tiation of all other research at the 
local level, the NIH review and approv- 
al of all research under the Guidelines 
will continue as before. All protocols 
not found to be in conformance must 
be modified. Given the slowly increas- 
ing sophistication of Investigators and 
IBCs alike, plus the provision in the 
Guidelines of explicit standards for 
performance of their duties. I am con- 
fident that this delegation will in no 
sense present risks to the health or 
the environment. 
It should also be noted that some 
commentators still regard proposed 
administrative procedures as "exces- 
sive and disproportionate when meas- 
ured against the perceived risks." 
They are especially concerned that 
the work of the IBCs is taxing the 
human and financial resources of the 
institution. That a burden is placed on 
the local institutions cannot be denied, 
but the responsibility is better delegat- 
ed than retained at the Federal level. 
As we learn more, there will presum- 
ably be less and less need for formality 
and centralized review in the gover- 
nance of this research. In anticipation 
of probable decentrallztion with time, 
creation of the local capability must 
begin without delay. 
Another commentator urged that 
the Guidelines be extended to all haz- 
ardous biological research. As stated in 
my Decision of July 28. I do not be- 
lieve we can or should extend the 
Guidelines to other research at this 
time. However, the er^ire area of labo- 
ratory safety is of prime concern to 
NIH and the subject of constant 
review and attention. NIH activities in 
this area are described in the Environ- 
mental Impact Assessment published 
with the Guidelines as proposed in 
July. It should be noted that some 
IBCs. as one correspondent pointed 
out, assume the added duty of moni- 
toring work with known pathogens 
that is not related to recombinant 
DNA technology. 
In view of/the delegation, some com- 
mentators urged that there be more fi- 
nancial support for the operations of 
the IBC. It was recommended that 
NIH require some percentage of the 
overhead charged on recombinant 
DNA research proposals to be ear- 
marked for operation of the IBCs. 
Concern has been expressed in the 
past about the cost of the IBC oper- 
ations. As stated before, NIH already 
pays for the operations of such com- 
mittees through reimbursement of so- 
called indirect costs of research. I do 
not believe there is need at this time 
to separate them from other Indirect 
costs of the institutions. 
Reduction of Containment Levels. A 
number of commentators and wit- 
nesses questioned the authority of the 
IBCs to lower containment require- 
ments for certain experiments. On the 
other hand, many believe the IBCs 
should be authorized both to reduce 
and to raise containment levels. It 
should be understood clearly that the 
IBCs’ authority to lower containment 
levels is quite limited and governed by 
strict standards and procedures set 
forth in the Guidelines. NIH is noti- 
fied of all such discretionary actions. 
It will review them and require that 
any failures to come up to the stand- 
ards of the Guidelines will be correct- 
ed. 
Specifically, the IBC can reduce con- 
tainment levels only for experiments 
using purified DNA and for character- 
ized clones. Standards and procedures 
for the former action are stated in 
Section III-A-3-a of the Guidelines 
and in Footnote 41: those for the 
latter action, in Section III-A-3-b and 
in Footnote 3. Standards for both ac- 
tions appear also in the IBC section of 
part IV of the Guidelines and in great- 
er detail in the Administrative Prac- 
tices Supplement. Further. It should 
be noted that NIH approval is re- 
quired for any lowering of contain- 
ment levels below PI + EK1. or by 
more than one step, or for experi- 
ments involving primate DNA. 
Specific authority Is granted to the 
institution (Section IV-D-1) to estab- 
lish requirements deemed necessary 
for the implementation of these 
Guidelines. The IBC. then, can raise 
containment levels. The national 
standards, however, are very conserva- 
tive. and In my view, to raise them 
generally or for characterized clones 
and purified DNA is unwarranted. 
Appeals. Several commentators advo- 
cated. in light of the authority dele- 
gated to the IBCs. procedures for "ap- 
pealing a decision of the local IBC 
against a project or against a certifica- 
tion of facility." The Guidelines do 
not prescribe an appellate mechanism. 
A full partnership of investigators and 
their institutions is intended in main- 
taining compliance with the Guide- 
lines. The Investigators and the IBCs 
must not be cast in adversary roles, 
and NIH will make every effort to pro- 
mote their cooperation. We will be 
available on request to provide techni- 
cal advice and consultation with prin- 
cipal Investigators and institutional 
committees alike. 
Emergency Plans. The IBC has re- 
sponsibility to review and approve 
emergency plans. A number of com- 
mentators suggested greater detail in 
the Guidelines on the emergency pro- 
cedures to be employed, including 
specification for cleanup procedures to 
be followed should there be a spill or 
accidental release of organisms into 
the environment. Other commentators 
suggested that the Guidelines set na- 
tional standards for the handling of 
emergency spills. Several urged that 
the biosafety officer at each institu- 
tion be charged with responsibility for 
drafting such plans. 
The Laboratory Safety Monograph 
presents guidance on pages 194-196 on 
procedures to be followed in emergen- 
cies. Some of that information is now 
included in the Guidelines to empha- 
size its importance. The monograph 
will be revised further, in response to 
comments, to provide greater detail 
and to include emergency numbers at 
NIH and the Center for Disease Con- 
trol that can be called on a 24-hour 
basis. The two agencies will provide 
consultation and .direct assistance if 
needed. In addition, the Guidelines 
specify that the institution shall coop- 
erate with the State and local public 
health departments and report to 
them any illness or laboratory acci- 
dent that appears to be a hazard to 
the public health. And the IBC chair- 
person is responsible for notifying the 
institution and NIH. within 30 days, of 
problems with the Guidelines, viola- 
tions. or significant research-related 
accidents or illnesses, unless the chair- 
person finds that the PI has done so. 
Public Access. Several witnesses at 
the September 15 hearing and many 
commentators urged greater public 
access to proceedings of the IBC. The 
proposed revised Guidelines required 
that minutes of the IBC meetings be 
made available to the public upon re- 
quest. However, there were several 
suggestions for further requirements. 
Witnesses urged that the IBC meet- 
ings be publicized and open to the 
public, except for those specifically 
dealing with proprietary or other con- 
fidential Information. Suggestions 
were made to enchance public partici- 
pation through evening meetings of 
the committee and the use of lay sum- 
maries of research proposals. Proce- 
dures were recommended for announc- 
ing IBC meetings. Others recommend- 
ed that all MUAs and reports of in- 
spections be made publicly available. 
The DHEW Committee spent a great 
deal of time reviewing comments 
about this portion of the Guidelines. 
In my Decision accompanying the pro- 
posed revision of July 28. I noted that 
possible discussion of proprietary and 
patentable information often pre- 
cludes open IBC meetings. I did urge, 
however, that local committees have 
open meetings when possible and that 
they be publicly announced. 
In response to the issues raised, and 
in view of the increased responsibility 
given to the local institutions, the 
final Guidelines require, in addition to 
public representation on the commit- 
tee, public access to proceedings of the 
IBC. Institutes are encouraged to open 
IBC meetings to the public whenever 
possible, consistent with the protec- 
FEDERAL REGISTER. VOL 43, NO. 247 — FRIDAY, DECEMBER 22. 1978 
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