60096 
NOTICES 
techniques. The DKEW Committee re- 
viewed this matter, and on the basis of 
the review, the responsibilities have 
been clarified. The institution is re- 
sponsible for ensuring appropriate 
training for IBC chairpersons and 
members, laboratory staff, and the 
BSO. The IBC chairperson will brief 
the IBC members and provide what- 
ever information on training is re- 
quired for them to fulfill their respon- 
sibilities. To the PI is delegated re- 
sponsibility for training all the labora- 
tory workers involved in the project. 
Safety Practices. The PI is responsi- 
ble for correcting work errors and con- 
ditions that may result in the release 
of recombinant DNA materials. Sever- 
al commentators suggested that any 
accidental release of recombinant or- 
ganisms. regardless of suspected path- 
ogenicity, be reported to the proper 
health authorities. The Guidelines 
now require the Institution to report 
to State and local health departments 
any significant research-related illness 
or accident that appears to be a 
hazard to the public health. 
Another commentator suggested 
that the PI be required to halt on- 
going research if any problems result 
in a failure to meet assigned contain- 
ment requirements. It was suggested 
that the research be halted for 24 
hours while a report is made to the 
IBC. The IBC would then certify in 
writing that the necessary repairs 
have been made. The Guidelines re- 
quire reporting and correction of such 
problems by the investigator, but they 
do not specify a time limit except that 
reports must be made to NIH within 
30 days on any significant problems 
with the Guidelines, on violations, and 
on all significant research-related acci- 
dents and Illnesses. Nor do they re- 
quire the IBC to document the re- 
parts. While these mandates are not 
necessary, the Institution should con- 
sider setting such policies as deemed 
necessary. The Laboratory Safety 
Monograph and the Guidelines con- 
tain increased information on health 
surveillance to assist the PI in his re- 
sponsibilities in this area. 
Exemptions and Exceptions. An- 
other commentator suggests that the 
PI receive IBC approval before peti- 
tioning the NIH for exemptions to the 
Guidelines or exceptions to the prohi- 
bitions. In light of the enhanced re- 
sponsibilities of the local IBCs, it is ap- 
propriate for them to review proposals 
for exceptions fo the prohibitions. Ac- 
cordingly, the Guidelines now state 
that proposals to NIH must be submit- 
ted with the concurrence of the IBC. 
Proposals for exemptions from the 
Guidelines deal with alterations in 
standards applied to all engaged in 
this research. Scientists may send 
those proposals directly to NIH for 
the considerations of the RAC with 
notice to the IBC. Note of exemptions 
granted will be sent to all IBCs. Ex- 
periments that are exceptions to the 
prohibitions require approval at the 
national level, after which they must 
be reviewed and approved by the IBC. 
An MUA must then be approved by 
NIH before the experiment may be 
initiated. 
MU As. Several commenters suggest- 
ed that the Guidelines be clarified 
with respect to the types of experi- 
ments that may not be started prior to 
NIH approval. As noted previously, 
the Administrative Practices Supple- 
ment is responsive to the suggestion, 
and more guidance is given in the sec- 
tion of the Guidelines on ■'Institu- 
tions” (IV-D-1) to clarify the prepara- 
tion and submission of MU As for new 
and modified experiments. 
Publication. The Guidelines recom- 
mend that published research articles 
specify the containment procedures 
used. A commentator advocates that 
this be required. The issue has been 
raised before, and it remains our view 
that NIH neither can nor should con- 
trol what must be included in scientif- 
ic publications. 
RESPONSIBILITIES OP NIH (GENERAL) 
Due Process Considerations 
A number of commentators spoke on 
the issue of public participation, in- 
cluding how best to inform the public 
and ensure public access to NIH pro- 
ceedings. A number of commentators 
and witnesses at the September 15 
hearing focused on the provisions call- 
ing for ‘'appropriate notice and oppor- 
tunity for public comment.” Several 
suggested that those provisions be de- 
scribed in greater detail in the Guide- 
lines. Other commentators urged that 
labor and environmental representa- 
tives, consumer advocacy groups, 
public health officials, and govern- 
ment agencies with potential regula- 
tory responsibility have full access to 
decision-making. 
Some commentators called for clari- 
fication of procedures for certifying 
host-vector systems. Others asked that 
the standards and procedures for 
future Guideline revisions be explicit- 
ly stated. Another wanted procedures 
that clearly set forth public notice and 
comment in advance of RAC decisions. 
And another believed the proposed 
Guidelines "exacerbate the problems 
of self-regulation” and urged that 
"HEW supervise the administration 
and enforcement of the Guidelines.” 
One commentator suggested a proce- 
dural mechanism for minor or partial 
revisions. He advised that RAC recom- 
mendations be published in the Feder- 
al Register for comment, and that 
the comments be taken into account 
by the RAC before it forwards final 
recommendations to the Director. 
Thus, NIH in these cases would act in 
the light of advice reflecting public 
views. 
Another commentator suggested 
that each time NIH receives an appli- 
cation for an exception to a prohibited 
experiment, notice be published in the 
Federal Register, and that after a 
public comment period, final notice of 
agency action should also be published 
there. 
NIH Procedures. The NIH Guide- 
lines of 1976 provided little or no dis- 
cretion in their administration or revi- 
sion. As a result, many recommenda- 
tions by the RAC could not be accept- 
ed because of NIH's lack of authority 
under those Guidelines to approve 
them. The revision proposed by the 
RAC in September 1977 attempted to 
correct this inflexibility by providing 
for discretion under specified condi- 
tions. with procedures set forth to 
ensure opportunity for public notice 
and comment. However, the standards 
and procedures for exercise of discre- 
tionary authority in the proposed revi- 
sion, as many of the commentators 
pointed out, needed greater definition 
and clarity. 
The commentators' procedural rec- 
ommendations provided a focus for 
the DREW Committee in its intensive 
review of these issues in the proposed 
revisions. Other comments from the 
scientific community, from many wit- 
nesses at the public hearing, and from 
a DHEW meeting with environmental 
interest groups augmented the efforts 
to define avenues for appropriate utili- 
zation of NIH authorities. On the 
basis of the comments made in corre- 
spondence and at the September 15 
hearing, part IV has been substantial- 
ly revised to provide for public access 
and participation in NIH activities 
under the Guidelines. It clearly sets 
forth the procedures that will govern 
the exercise of NIH authority. 
First, there is a group of major ac- 
tions for which the NIH Recombinant 
DNA Advisory Committee (RAC) will 
advise the Director after an opportuni- 
ty for public and Federal agency com- 
ment. These actions include lowering 
or assignment of containment levels 
where the Director judges the action 
to be major; certification of new host- 
vector systems; exceptions to the pro- 
hibitions; modification of a list of re- 
combinant DNA sources (microorgan- 
isms) to be exempt from the Guide- 
lines and other changes in the Guide- 
lines. 
For these major actions the follow- 
ing procedures apply. The Director 
must seek the advice of the RAC and 
provide an opportunity for public and 
Federal agency comment. Specifically, 
the agenda of the RAC meeting citing 
the major actions will be published in 
the Federal Register at least 30 days 
before the meeting, and the Director 
will simultaneously publish the pro- 
FEDERAl REGISTER, VOL 43, NO. 247— FRIDAY. DECEMBER 22, 1978 
[19] 
