33064 
NOTICES 
i particular host-vestor system be cer- 
tified: and (2) certification of the 
system by the Director. NIH. The 
PRG-RAC clarifies the fact that a 
two-step procedure is followed. The ra- 
tionale for the two-step procedure is 
that it allows the Director. NIH. to so- 
licit the opinions of additional experts 
prior to making a final decision on cer- 
tification. 
The RAC's authority to recommend 
exceptions from the proibltions was 
also clarified. The 1976 version of the 
Guidelines envisioned the possibility 
of the RAC's recommending an excep- 
tion to the 10-liter limit on culture 
volume for recombinant DNA's known 
to make harmful products. The pro- 
posed revision would extend the possi- 
bility of an exception to the five other 
classes of currently prohibited experi- 
ments. The general rationale for this 
addition is the RAC's inability to fore- 
see all possible future circumstances 
and the RAC's desire to specify, 
within the limits of strict safeguards, 
the possibility of an exception for 
'compelling social or scientific reasons. 
A more Immediate and specific justifi- 
cation for the paragraph on excep- 
tions from the prohibitions is that the 
risk-assessment studies necessary for a 
clearer understanding of the potential 
biohazards of recombinant DNA re- 
search may not be able to be carried 
out without technical violations of the 
current Guidelines, unless there is a 
mechanism for approving exceptions. 
REVIEW or COMMENTS AND Hill PROPOSED 
cm SEINES 
As in the public hearing on the origi- 
nally proposed Guidelines in 1976. 
many public commentators urged 
openness, candor, and public participa- 
tion in the revision process, emphasiz- 
ing shared responsibility and account- 
ability from the local to the national 
level. We have heeded these sugges- 
tions. In addition to holding all RAC 
meetings in the open and holding a 
public hearing on the PRG-RAC in 
December 1977. we have published 
both the PRG-RAC and now the 
PRG-NIH in the Federal Register for 
public comment. 
It remains clear, as stated in my 
1976 decision, that much of the suc- 
cess of the guidelines will depend on 
the wisdom with which they are im- 
plemented. The recommendations of 
the PRG-RAC have been carefully 
weighed along with other public and 
scientific comments received on the 
"roles and responsibilities" section. In 
general. I have adopted the RAC pro- 
posals with certain additional modifi- 
cations based on issues raised by the 
Directors Advisory Committee and 
other commentators. The issues I have 
considered, and a discussion of them 
follows: 
Responsibilities of the institution 
( general ) 
Again, as in 1976. this section of the 
guidelines drew considerable comment 
directed to the roles and responsibil- 
ities of the institution and its several 
constituents. Generally, commentators 
requested more information and great- 
er clarification of the structure and 
operation of the IBC. the function of 
the biological safety officer, and the 
duties of the institution. Because of 
the importance of this section with 
regard to successful implementation of 
the guidelines, and therefore safe con- 
duct of this research, these sugges- 
tions and comments have been careful- 
ly considered. NIH acknowledges its 
special responsibility in assuming lead- 
ership in developing and promoting 
safety programs relevant to recombin- 
ant DNA research. Therefore, as in 
1976. another committee chaired by 
Dr. W. Emmett Barkley, Director. 
Office of Research Safety. NCI. was 
convened to address concerns raised. 
As a result, and in response to a 
number of commentators' requests, 
appendix D of the original guidelines 
has been restored and enhanced to 
give additional advice on safety mat- 
ters (see Laboratory Safety Mono- 
graph— A Supplement to the NIH 
Guidelines for Recombinant DNA Re- 
search"). The revised guidelines also 
retain requirements for emergency 
plans to cover accidents as well as 
strengthening the requirement for 
training of all recombinant DNA re- 
searchers in safe laboratory proce- 
dures. 
The intent of this section, as before, 
is to integrate safety practice into the 
conduct of recombinant DNA research 
and to assign responsibilities for this 
to the principal investigator institu- 
tion. IBC. and biological safety officer. 
Therefore, it is important that these 
responsibilities be stated in an unam- 
biguous manner. For this reason, and 
in response to many commentators. 
Part IV has been restructured, to dis- 
tinguish in greater detail and more 
clearly align some of these functions. 
The appendices contain additional 
complementary information on roles 
and responsibilities, including infor- 
mation for IBCs and biological safety 
officers. 
In response to several comments, the 
scope of review of research has been 
broadened to cover all recombinant 
DNA research at an institution receiv- 
ing funds from NIH for recombinant 
DNA research, whether or not the spe- 
cific recombinant DNA project is being 
funded by NIH. While this increases 
the responsibility of the institution 
and the IBCs, it is believed that this 
revision will enhance the overall 
safety of the conduct of this research. 
Furthermore, at the suggestion of one 
commentator. I nave decided to 
change the name of the biohazards 
committees to biosafety committees to 
reflect the spirit of the guidelines 
more closely. 
Several generic comments deserve to 
be highlighted as they represent sig- 
nificantly increased authority to be 
delegated to the institution. In 1976, 
the RAC did not accept commentators’ 
suggestions for requiring local commit- 
tees to make an Independent evalua- 
tion of the containment levels re- 
quired by the guidelines for individual 
research projects. I therefore stated in 
the 1976 decision that NIH would not 
require local institutions to have their 
committees perform this function, al- 
though they would not be prohibited 
from doing so. Commentators have 
now noted that in order for an IBC to 
accomplish its mandated responsibil- 
ities under the 1976 guidelines, includ- 
ing reviewing and approving recombin- 
ant DNA research projects, it has been 
necessary for the committee Implicitly 
to determine containment conditions. 
Therefore, in order to better clarify its 
role, the assessment of appropriate 
containment levels is now made an ex- 
plicit responsibility of the IBC. 
In addition, institutions through 
their IBCs will be given increased re- 
sponsibility for primary oversight of 
this research as they have now been 
delegated the authority from NIH to 
approve or disapprove proposed re- 
combinant DNA projects. NIH 
through ORDA will conduct a review 
of institutional actions, upon registra- 
tion of the projects, to ensure compli- 
ance with the NIH guidelines, thereby 
maintaining a national standard for 
the research. This action has been in 
response to several comments calling 
for increased local responsibility and a 
more simplified administrative process 
with regard to gaining approval for 
this research to proceed. In view of 
the impossibility of Federal surveil- 
lance to enforce these standards exter- 
nally. I feel it is essential to increase 
the authority and responsibility of the 
local institution. It was also requested 
that IBCs have a role if legislation in 
this area is adopted, and this concept 
is endorsed in the bill report of March 
24. 1978. on the Recombinant DNA 
Act, by the House Committee on In- 
terstate and Foreign Commerce, which 
says, “It is the view of the committee 
that the appropriate portions of the 
administrative requirements of section 
IV of the NIH guidelines are a reason- 
able model 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 spe- 
cific safety requirements appropriate 
to each project or activity is an effec- 
FEDCRAl REGISTER, VOL 43. NO. 144— fRIDAY, JULY 7t. 197* 
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