214 • Impacts of Applied Genetics— Micro-Organisms, Piants, and Animais 
representatives from various Federal agencies 
serve as nonvoting members. 
ORDA performs administrative functions, 
which include reviewing and approving IBC 
membership and serving as a national center 
for information and advice on the Guidelines 
and rDNA activities. 
The Interagency Committee was established in 
October 1976 to advise the Secretary of the then 
Department of Health Education and Welfare 
(HEW) [now Health and Human Services 
(DHHS)] and the Director of NIH on the coor- 
dination of all Federal activities relating to 
rDNA. It has thus far produced two reports. Its 
first, in March 1977, concluded that existing 
Federal law would not permit the regulation of 
all rDNA research in the United States to the ex- 
tent considered necessary® and recommended 
new legislation, specifying the elements of that 
legislation.'® The second, in November 1977, 
surveyed international activities on regulating 
the research and concluded that, while appro- 
priate Federal agencies should continue to work 
closely with the various international organiza- 
tions, no formal governmental action was neces- 
sary to produce international control by means 
of a treaty or convention." It is currently con- 
sidering issues arising from the large-scale in- 
dustrial applications of rDNA techniques. 
Under the Guidelines, essentially all the re- 
sponsibility for overseeing rDNA experiments 
lies with those sponsoring or conducting the re- 
search. The Institution must implement general 
safety policies,* establish an IBC, which meets 
specified requirements, and appoint a Biological 
Safety Officer. The Biological Safety Officer, who 
is needed only if the Institution conducts ex- 
periments requiring P3 or P4 containment, (see 
table 35) oversees safety standards. The initial 
responsibility for particular experiments lies 
^Interim Report of the Federal Interagency Committee on Recom- 
binant DNA Research: Suggested Elements for Legislation, Mar. 15, 
1977, pp. 9-10. 
'“Ibid., pp. 1 1-15. 
"Report of the Federal Interagency Committee on Recombinant 
DNA Research: International Activities, November 1977, pp. 13-15. 
‘These include conducting any bealib surveillance ibat it deter- 
mines to be necessary and ensuring appropriate ti aining tor the 
IBC, Biological Satety Otlicers, Principal Investigators, and labora- 
tory staff. 
with the PI, the scientist receiving the funding. 
This person is responsible for determining and 
implementing containment and other safe- 
guards and training and supervising staff. In ad- 
dition, the PI must also submit a registration 
document that contains information about the 
project to the IBC, and petition NIH for: 1) cer- 
tification of host-vector systems, 2) exceptions 
or exemptions from the Guidelines, 3) and de- 
termination of containment levels for experi- 
ments not covered by the Guidelines. Further- 
more, all of the above have certain reporting re- 
quirements designed so that ORDA is eventually 
informed of significant problems, accidents, \ io- 
lations, or illnesses. * * 
The IBC is designed to prox ide a (|uasi-inde- 
pendent review of rDNA work done at an in- 
stitution. It is responsible for: 1) rex iewing all 
rDNA research conducted at or s[)onsored by 
the institution and approxing those pi'ojects in 
conformity with the Guidelines: 2) periodically 
reviewing ongoing projects; 3) adopting emer- 
gency plans for spills and contamination; 4) 
lowering containment levels for certain rDN.A 
and recombinant organisms in xvhich th(> ab- 
sence of harmful se(|uences has hec'ii (>stah- 
lished; and 5) reporting significant problems, 
violations, illnesses, or accidents to ORD.A 
within 30 days.*** Fhe IBC! must he com|)rised 
of no fewer than five members xxho can col- 
lectively assess the risks to health or the en- 
vironment from the (bxperiments. At least 20 
percent of the memh(M\ship must not he other- 
wise affiliated with the institution xxhere the 
work is being done, and must re[)re.sent the in- 
terests of the surrounding community in jiro- 
tecting health and th(? enx ironment. Comm- 
mittee members cannot rexiexx a project in 
which they hax e been, or e,\|)ect to he, inxoix ed 
or have a direct finant'ial interest. Finally, ilu' 
Guidelines suggest that IBC meetings he public: 
minutes of the m(u4ings and submitted docu- 
ments must h(! axailahle to the public on 
request. 
* ‘ The I’l Ls rc(|uit'(‘(l to rcporl this inliM'm.iliiin ilhin .1(1 d.n -• In 
ORDA and bi.s IB( . I he Biological Salcl\ Olliccc iiiiinI ll•(Mll l (hi- 
same lo llui Inslidilion and ibe IB( unless the 1*1 has done so I be 
Inslitullon nuisl reporl uilbln .III d.i\s lo ()RI)\ unless ihe I'l 
IBC has done so. 
“'ll does nol ba\i‘ lo reporl il llie I’l h.is done so 
