Ch. 11 — Regulation of Genetic Engineering • 213 
Table 35. — Containment Recommended by 
National Institutes of Health 
Biological — Any combination of vector and host must be 
chosen to minimize both the survival of the system 
outside of the laboratory and the transmission of the 
vector to nonlaboratory hosts. There are three levels 
of biological containment; 
HV1— Requires the use of Escherichia coli K12 or 
other weakened strains of micro-organisms that 
are less able to live outside the laboratory. 
HV2— Requires the use of specially engineered strains 
that are especially sensitive to ultraviolet light, 
detergents, and the absence of certain 
uncommon chemical compounds. 
HV3— No organism has yet been developed that can 
qualify as HV3. 
Physical — Special laboratories (P1-P4) 
PI— Good laboratory procedures, trained personnel, 
wastes decontaminated. 
P2— Biohazards sign, no public access, autoclave in 
building, hand washing facility. 
P3— Negative pressure, filters in vacuum line, class II 
safety cabinets. 
P4— Monolithic construction, air locks, all air 
decontaminated, autoclave in room, all 
experiments in class III safety cabinets (glove 
box), shower room. 
SOURCE; Office of Technology Assessment 
nant DX.A ,Acti\ities (ORDA), 4) the Federal In- 
teragency Ad\ isorv Committee on Recombinant 
DN'.A Research (Interagency Committee), 5) the 
Institution where the research is conducted, 6) 
the Institutional Biosafety Committee (IBC), 7) 
the Principal In\estigator (PI), and 8) the Bio- 
logical Safety Officer. 
The Director of t\IH carries the primary bur- 
den for the Federal Go\ ernment’s oversight of 
rDNA activities, since he is responsible for im- 
plementing and interpreting the Guidelines, es- 
tablishing and maintaining R.AC (a technical ad- 
\ isorv committee) and ORDA (whose functions 
are purely administrath e), and maintaining the 
Interagency Committee (which coordinates all 
Federal acti\ities relating to rDNA). Under this 
arrangement, all decisions and actions are taken 
by the Director or his staff. For major actions, 
the Director must seek the advice of RAC, and 
he must provide the public and other Federal 
agencies with at least 30 days to comment on 
proposed actions. Such actions include: 1) 
assigning and changing containment levels for 
e.\j)eriments, 2) certifying new host-vector sys- 
tems, 3) maintaining a list of rDNA molecules ex- 
empt from the Guidelines, 4) permitting excep- 
tions to prohibited experiments, and 5) adopting 
changes in the Guidelines. 
For other specified actions, the Director need 
onh' inform R.AC, the IBC's, and the public of his 
decision. The most important of tliese are: 1) 
making minor interpretive decisions on contain- 
ment for certain experiments; 2) authorizing, 
under procedures specified by RAC, large-scale 
work (in\'ol\ ing more than 10 1 of culture) with 
rDN.A that is rigoi'ously characterized and free 
of harmful seciuences; and 3) supporting labora- 
tory safety training programs. Every action 
taken by the Director pursuant to the Guide- 
lines must present "no significant risk to health 
or the en\ ironment.” 
R.AC is an adx isory committee to the Director 
on technical matters. It meets quarterly. Its pur- 
pose, as described in its current charter of June 
26, 1980 (and unchanged since its inception in 
October 1974), is as follows: 
The goal of the Committee is to investigate 
the current state of knowledge and technology 
regarding DNA recombinants, their survival in 
nature, and transferability to other organisms; 
to recommend guidelines for the conduct of 
recombinant DNA experiments; and to recom- 
mend programs to assess the possibility of 
spread of specific DNA recombinants and the 
possible hazards to public health and to the en- 
vironment. This Committee is a technical commit- 
tee, established to look at a specific problem. (Em- 
phasis added.) 
The charter and the Guidelines also assign it 
certain advisory functions that have changed 
over time. 
The RAC is composed of not more than 25 
members. At least eight must specialize in mo- 
lecular biology or related fields; at least six must 
be authorities from other scientific disciplines; 
and at least six must be authorities on law, 
public policy, the environment, public or oc- 
cupational health, or related fields. In addition. 
