Ch. 1— Summary: Issues and Options • 19 
appropriate to the use of the micro-organisms 
serx ing as the source of n\A are reciuirecl. Nev- 
ertheless. it has not been demonstrated that 
comhining those genes in the form of rDNA is 
anv more hazardous than tlie original source of 
the DNA. 
Perceptions of the nature, magnitude, and ac- 
ceptability of the I’isk differ. In addition, public 
concern has been e.xpressed about possible 
long-range im[)acts of genetic engineering. In 
this conte.xt, the problem facing the policy- 
maker is how to address the risk in a way that 
accommodates the perceptions and \alues of 
those who hear it. 
The N'lH (iuidelines for Research Inxohing 
Recombinant DN'.A .Molecules and existing Fed- 
eral laws appear adequate in most cases to deal 
v\ith the risks to health and the enxironment 
presented by genetic engineering. Howex er, the 
(iuidelines are not legally binding on industry, 
and no singU’ statute oi’ combination xx ill clearly 
cox er all foreseeable commercial applications of 
genetic engineering. 
The Guidelines are a flexible exolx ing oxer- 
sight mechanism that combines technical exper- 
tise xvith public participation. They coxer the 
most xvidely used and possibly risky molecular 
genetic technique— rDN'A— prohibiting experi- 
ments using dangerous toxins or pathogens and 
setting containment standards for other poten- 
tially hazardous experiments. .Although compli- 
ance is mandatory only for those receix ing NIH 
funds, other Federal agencies folloxv them, and 
industry has proclaimed voluntary compliance. 
Rare cases of noncompliance have occurred in 
universities but have not posed risks to health 
or the environment. As scientists hax e learned 
more about rDNA and molecular genetics, the 
restrictions have been progressively and sub- 
stantially relaxed to the point xvhere 85 percent 
of the experiments can noxv be done at the 
loxvest containment levels, and virtually all 
monitoring for compliance noxv rests xvith ap- 
proximately 200 local self-regulatory commit- 
tees called institutional biosafety committees 
(IBCs). (See table 1.) 
Under the Guidelines, NIH serx'es an impor- 
tant oversight role by sponsoring risk assess- 
Table 1.— Containment Recommended by the 
National Institutes of Health 
Biological — Any connbination 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. 
ment programs, certifying nexv host-vector sys- 
tems, serx ing as an information clearinghouse, 
and coordinating Federal and local activities. 
Limitations in NIH’s oversight are that: it lacks 
legal authority ox er industry; its procedures for 
adx’ising industry on large-scale projects have 
not incorporated sufficient expertise on large- 
scale fermentation technology; its monitoring 
for either compliance or consistent application 
of the Guidelines by individuals or institutions is 
x'irtually nonexistent; and it has not systemati- 
cally ex aluated other techniques, such as cell fu- 
sion, that might present risks. 
Federal laws on health and environment will 
coxier most commercial applications of genetic 
engineering. Products such as drugs, chemicals, 
and foods can be regulated by existing laws. 
However, uncertainty exists about the regula- 
tion of either production methods using engi- 
neered micro-organisms or their intentional 
release into the environment, when the risk has 
not been clearly demonstrated. While a broad 
interpretation of certain statutes, such as the 
Occupational Safety and Health Act and the 
Toxic Substances Control Act, might cover these 
