NOTICES 
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review and monitoring responsibilities, 
there should be no distinction between 
NIH- and non-NIH-funded projects. 
Another commentator urged that 
the Guidelines give greater detail on 
the types of protocol changes for 
which a new or revised MUA must be 
sent to NIH. Information proviously 
contained in Appendix C has now been 
added to the Guidelines to clarify this 
point, and further information is con- 
tained in the APS. 
Another commentator suggested 
that the institution be required to 
notify a local Health Systems Agency 
upon filing an application for Federal 
support of recombinant DNA research. 
This is not applicable to HSA responsi- 
bilities under section 1513(e) of the 
PHS Act and therefore is not mandat- 
ed. 
Another correspondent requested 
that Appendix C be mandated. The 
test of Appendix C, now in a supple- 
ment to the Guidelines (the APS), has 
been extensively rewritten, and many 
of its features have been incorporated 
in the Guidelines for purposes of clari- 
fication. I agree that the provisions 
now in the Guidelines should be man- 
datory. 
Institutional Compliance. A com- 
mentator challenged the right of NIH 
to require an institution to hold that 
all principal investigators, irrespective 
of source of funding, must follow the 
Guidelines. This requirement, howev- 
er, is vital to the maintenance of uni- 
form standards and is therefore re- 
tained. On the other hand, research 
supported by another Federal Agency 
need not be registered with NIH when 
that agency maintains a registry and 
provides NIH with essential informa- 
tion. 
Another commentator suggested del- 
egating responsibilities for all enforce- 
ment of the Guidelines to the institu- 
tion (IBC), with ORDA receiving peri- 
odic reports from the committees on 
the research they are regulating. 
There are several reasons such a 
course would be unwise at this time. 
Exercise of any discretion is a new re- 
sponsibility for the IBC’s. Uniformity 
and expertise must be demonstrated 
by verification through NIH review. A 
great deal of standard-setting, neces- 
sarily central at present, is yet to be 
done through case-by-case analysis. 
One commentator requested that 
the NIH notify both the IBC chairper- 
son and the institution when it was re- 
viewed each action of the IBC accord- 
ing to the imformation submitted on 
the MUA. This, I believe, would 
strengthen coordination of compliance 
efforts. The final Guidelines accord- 
ingly require the double notification. 
It was also suggested that NIH pro- 
vides a statement that it has certified 
the institution and finds it to be in 
compliance. This request is related to 
requirements in State regulations that 
go beyond the Guidelines. However, 
NIH plans to provide official documen- 
tation to institutions in States requir- 
ing such information. The subject will 
be further treated in the APS. 
Another commentator urged NIH to 
devise a system to protect those who 
report possible violations. This issue 
was reviewed in my Decision accompa- 
nying the proposed revised Guidelines 
(Federal Register, July 28, 1978, p. 
33065), where I noted that grievance 
procedures for workers under the 
Guidelines were not considered neces- 
sary because OSHA rules and regula- 
tions already provide such a mecha- 
nism. However, witnesses at the Sep- 
tember 15 hearing and comments from 
OSHA state that the Occupational 
Safety and Health Act does not cover 
employees of State and local govern- 
ments unless the State operates under 
an OSHA-approved State plan cover- 
ing health and safety practices and 
grievance procedures. Only 23 States 
currently have such plans. But other 
States presumably have similar statu- 
tory protection, and it would be pre- 
sumptuous of NIH to attempt to detail 
specific grievance procedures in all ju- 
risdictions. The Guidelines require the 
reporting of violations and allow the 
reports to be made to NIH by anyone. 
The institutions, I believe, will accept 
such reports in a positive light and as 
an important aid in maintaining com- 
pliance with the NIH standards. 
Institutional Biosafety Committee 
(IBC) 
The principal functions of the IBC 
are to review and oversee all recombin- 
ant DNA projects with respect to com- 
pliance with these Guidelines and to 
advise the institution and ORDA 
whether the proposals and the re- 
search so comply. A number of issues 
concerning EBCs were addressed by 
the commentators and witnesses at 
the September 15 hearing, including 
delegation of authority to the IBCs, 
public representation on the commit- 
tee, and public access to its proceed- 
ings. 
Delegation of Authority. Several cor- 
respondents and a number of wit- 
nesses at the September 15 public 
hearing took exception to the delega- 
tion of authority to the institutions 
and their IBCs to act on certain ex- 
periments without prior NIH approv- 
al. One witness noted that there has 
been a 4 to 15 percent error rate by 
the EBCs. He also noted that NIH 
review did not entail inordinate delays, 
citing the usual review at ORDA as 
taking only 4 to 5 days. He urged that 
NIH retain the present two-level 
system of review requiring prior NIH 
approval for all projects. The data 
here do not take into account addi- 
tional referrals of MUSs between 
ORDA and various NIH Institutes sup- 
porting such research. These have in- 
troduced delays of may days or weeks 
in processing. Other commentators 
recommended quite the opposite— that 
greater latitude be given the IBCs to 
assign containment levels for experi- 
ments. 
The reason for the delegation of au- 
thority is extensively discussed in my 
Decision and the Environmental 
Impact Assessment accompanying the 
July 28 publication of the proposed re- 
vised Guidelines. As stated in the Deci- 
sion document, the increased responsi- 
bility of the institution is in response 
to comments calling for a simpler ad- 
ministrative process and more local re- 
sponsibility. It is also a recognition of 
the practical requirements for enforce- 
ment of standards for use of such 
highly varied and complex technology 
in many institutions spread over a vast 
area. As stated by the House Commit- 
tee on Interstate and Foreign Com- 
merce- in its report of March 28, 1978, 
on the Recombinant DNA Act: “* * * 
the appropriate portions of the admin- 
istrative requirements of section IV of 
the NIH Guidelines are a reasonable 
model upon which the Secretary could 
base administrative regulations. In 
particular the current practice in the 
NIH Guidelines of delegating to local 
biohazard committees most of the re- 
sponsibility for the inspection of the 
facilities and the approval of the spe- 
cific safety requirements appropriate 
to each project or activity is an effec- 
tive and relatively inexpensive admin- 
istrative mechanism.” Thus, the dele- 
gation of increased responsibility at 
the local level is not primarily to fa- 
cilitate an increased volume of re- 
search, as suggested by a commenta- 
tor, but rather to place this function 
at the most appropriate location for 
initial enforcement of the Guidelines. 
It should be noted, however, that 
MUAs, before going to ORDA, go to 
the NIH Institute funding the re- 
search, and there have been, delays of 
days or weeks at this level, adding sub- 
stantially to the time required for 
processing. We will consider means to 
simplify procedures so the ORDA can 
respond in a timely fashion to the in- 
stitutions. 
The DHEW Committee carefully 
considered the issue of prior NIH ap- 
proval. On the basis of that review, 
the Guidelines now specify the cir- 
cumstances in which prior approval is 
required, with greater detail provided 
in the APS. In addition to the five cat- 
egories of experiments requiring prior 
approval in the NIH proposal, prior 
approval is now required, on the rec- 
ommendation of the DHEW Commit- 
tee, for the first project to be conduct- 
ed by an institution and the first proj- 
ect in a facility at P3 containment. 
FEDERAL REGISTER, VOL 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
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