33086 
NOTICES 
that the required safety practices and 
techniques are employed: 
IV-A-4-n-(2). Investigating and re- 
porting In writing to ORDA and the 
IBC any serious or extended illnesses 
of a worker or any accident that re- 
sults in (1) Inoculation of recombinant 
DNA materials through cutaneous 
penetration. <U) Ingestion of recombin- 
ant DNA materials. (Hi) probable inha- 
lation of recombinant DNA materials 
following gross aerosol ization. or (Iv) 
any incident causing serious exposure 
to personnel or danger of environmen- 
tal contamination: 
IV-A-4-n-<3>. Investigating and re- 
porting in writing to ORDA. the bio- 
logical safety officer (where applica- 
ble!. and the IBC any significant prob- 
lems pertaining to operation and Im- 
plementation of biological and physi- 
cal containment practices and proce- 
dures; 
IV-A-4-n-(4). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
IV-A-4-n-<5>. Insuring the Integrity 
of the physical containment (e.g.. bio- 
logical safety cabinets) and the bio- 
logical containment (eg., genotypic 
and phenotypic characteristics, purity, 
etc.k 
See “Laboratory Safety Mono- 
graph— A Supplement to NIH Guide- 
lines for Recombinant DNA Research" 
for additional Information on training 
and laboratory and accident proce- 
dures. 
IV-A-4-o. While not a requirement. 
It is urged that ail publications dealing 
with recombinant DNA research In- 
clude a description of the physical and 
biological containment procedures em- 
ployed. to aid others who might con- 
sider repeating the work. 
IV-B. Responsibilities of NIH. 
IV-B-1. Office o/ the Director. NIH 
The Office of the Director shall be re- 
sponsible for 
IV-B-1 -a. Final Interpretation of the 
guidelines; 
IV-B-l-b. Revision and amendment 
of the guidelines after appropriate 
notice and opportunity for public com- 
ment; 
IV-B-l-c. Certification of new host- 
vector systems and decertification of 
existing host-vector systems after ap- 
propriate notice and opportunity for 
public comment (see Section II-D-2- 
a): 
IV-B- Id. Promulgating and amend- 
ing a list of classes of recombinant 
DNA molecules to be exempt! 4) from 
these guidelines after appropriate 
notice and opportunity for public com- 
ment. If It Is found that they consist 
entirely of DNA segments from differ- 
ent species that exchange DNA by 
known physiological processes or oth- 
erwise do not present a significant risk 
to health or environment (see section 
I-E-4 and I-E-6): 
IV-B-l-e. Permitting, after appropri- 
ate notice and opportunity for public 
comment, exceptions! 4) to the Prohi- 
bitions in the guidelines for experi- 
ments — e.g., risk -assessment studies. In 
making such decisions on exceptions, 
weight will be given both to scientific 
and societal benefits and to potential 
risks (see section I-D). Also, approving 
changes in containment levels for spe- 
cific experiments, or the assignment of 
levels to experiments not explicitly 
considered in the guidelines (See part 
III). Also, designating as class 1 for 
purposes of these guidelines certain 
agents which are listed as class 2 (see 
footnote 1); 
IV-B-l-f. Overseeing the implemen- 
tation of the guidelines; 
IV-B-l-g. Requesting, when appro- 
priate, the advice of the Advisory 
Committee to the Director. NIH, on 
matters relevant to recombinant DNA 
policy issues; 
IV-B-I-h. Promulgating rules as 
necessary to Implement the guidelines. 
IV-B-2. NIH Recombinant DNA Ad 
visory Committee. The duties of the 
Recombinant DNA Advisory Commit- 
tee (RAC) shall Include: 
IV-B-2-a. Recommending to the Di- 
rector. NIH. revisions of these guide- 
lines periodically and any amendments 
to the guidelines as necessary". 
IV-B-2-b. Advising the Director. 
NIH. and ORDA on questions of inter- 
pretation of the guidelines: 
IV-B-2-c. Recommending to the Di- 
rector. NIH whether host-vector sys- 
tems qualify for certification (see sec- 
tion II-D-2-a); 
IV-B-2-d. Recommending to the Di- 
rector. NIH. whether currently certi- 
fied host-vector systems should be de- 
certified: 
IV-B-2-e. Recommending to the Di- 
rector. NIH. a list (and amendments to 
the list) of other classes of experi- 
ments to be exempt! 4) from these 
guidelines (see section I-E-4 and I-E 
S): 
IV-B-2-f. Recommending to the Di- 
rector. NIH. whether experiments 
should be granted an exception (4) 
from the prohibitions in the guide- 
lines— for example. In order to allow 
risk-assessment studies — and at the 
same time recommending appropriate 
levels of physical and biological con- 
tainment for these experiments. In 
making such recommendations, weight 
shall be given both to scientific and so- 
cietal benefits and to potential risks 
(see section I-D); 
IV-B-2-g. Recommending to the Di- 
rector. NIH. changes in containment 
levels for specific experiments, or the 
assignment of levels to experiments 
not explicitly considered in the guide- 
lines (see part III); 
IV-B-2-h. Recommending to the Di- 
rector. NIH. designation as class 1 for 
purposes of these guidelines certain 
agents that are listed as class 2 (see 
footnote 1); 
IV-B-2-i. Recommending to NIH 
whether a cloned recombinant DNA 
segment has been rigorously charac- 
terized and whether there is sufficient 
evidence that it is free of harmful 
genes, so that experiments involving it 
may be conducted under lower con- 
tainment conditions: 
IV-B-2-j. Carrying out other func- 
tions as assigned under the RAC's 
charter or by the Secretary, the As- 
sistant Secretary for Health, or the 
Director. NIH. 
IV-B-3. NIH Components. Various 
NIH components shall perform the 
following: 
IV-B 3 a. ORDA. ORDA shall serve 
as a focal point for information on re- 
combinant DNA activities and provide 
advice to ail within and outside NIH, 
Including institutions, biosafety com- 
mittees. principal investigators, and 
State and local governments. In addi- 
tion. ORDA shall: 
IV B 3-a-(l). Make an Independent 
evaluation of the containment levels 
required for the research covered by 
these guidelines; 
IV-B-3-a-(2). Determine whether 
the physical and biological contain- 
ment levels approved by the IBC are 
in accord with the requirements of the 
guidelines; 
IV-B-3-a-(3). Make interpellations 
of the guidelines and approve reduc- 
tion of containment levels of more 
than one step for characterized clones, 
or for cases involving primate DNA. or 
to levels below P1 + EK1 (see section 
III-A-3). In most cases this will in- 
volve prior review by the RAC; 
IV-B-3-a-(4). Provide timely notice 
to local institutions when protocols. 
Including modifications to ongoing 
projects, do not conform to the stand- 
ards in the NIH guidelines: 
IV-B-3-a-(5). Maintain a register of 
recombinant DNA projects; 
IV-B-3-a-(6). Serve as executive sec- 
retariat for the RAC; 
IV-B-3-a-<7). Publish the Recombin- 
ant DNA Technical Bulletin; 
IV-B-3-a-<8). Review membership of 
IBCs. 
IV-B-3-b. Other NIH Components. 
Other NIH components shall be re- 
sponsible for 
IV-B-3-b-(l). Awarding no grants or 
contracts unless properly executed 
MU As have been received; 
IV-B-3-b-(2). Certifying P4 facili- 
ties, inspecting them periodically, and 
inspecting other recombinant DNA fa- 
cilities as deemed necessary; 
IV-B-3-b-<3). Announcing and dis- 
tributing certified HV2 and HV3 host- 
vector systems (see section II-D-3). 
See Appendix C for additional infor- 
mation on the administrative proce- 
dures of ORDA and other NIH compo- 
nents. 
FEDERAL REGISTER, VOL 43. NO. 146— FRIDAY, JULY 28. 1978 
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