40 
4* Broad exemptions defeat the regulatory purpose of recombinant 
DNA legislation 
When the Interstate and Foreign Commerce Committee debated 
the issue of federal pre-emption of State and local statutes, the pre- 
vailing view was that a uniform standard should apply to all 
recombinant DNA research, unless local or State regulations were 
necessary to protect health or the environment. 
Clearly, granting power to the Secretary of HEW to exempt at will 
and by order any recombinant DNA research activities from the NIH 
safety guidelines defeats the goal of a uniform standard. It will create 
pockets of unregulated activities at research facilities across the 
country. 
5. Deregulation of some experiments and not others by order of the 
H.E.W. Secretary will invite litigation by scientists 
H.R. 11192 specifies no standards by which the Secretary can find 
that an experiment poses no “significant risk”. Deregulation of some 
experiments and not others will give certain researchers a competitive 
advantage over others. Institutions excused from the guidelines may 
be able to perform their experiments more quickly and at less cost. 
Fierce competition to find constructive commercial applications for 
recombinant DNA, as well as the current race to win a Nobel prize, 
will lead scientists to test the Secretary’s exemption orders in the 
courts. Manufacturers may assert legal claims that since exemptions 
are created by order rather than by regulations on which they can 
comment, exemptions granted to their competitors deny plaintiffs due 
process or equal protection. Manufacturers are sure to object if some of 
their competitors are relieved by the HEW Secretary from batch size 
limitations now imposed by the NIH guidelines. 
6. Broad exemptions for recombinant DNA experiments make the 
NIH guidelines more difficult to enforce 
Exemptions permitted by the Secretary of HEW will erode com- 
pliance with the NIH guidelines even in institutions which did not 
seek or were not granted exemptions. If it is known the Secretary ex- 
empted a certain type of experiment, scientists may see little reason 
to comply with safety guidelines if they are engaged in similar work. 
They will reason that the Secretary’s order indicates non-observance 
of certain guidelines does not pose a “significant” risk. A Secretary’s 
public order exempting a particular type of experiment from the NIH 
guidelines may be used in litigation to estop him from enforcing that 
guideline in any other research facility engaged in similar work. We 
feel that institutions not having an exemption will attempt to catch 
up with their competitors by disregarding the guidelines. 
7. The Secretary’s exemption power may expose laboratory workers 
to unknown risks 
H.R. 11192 grants the HEW Secretary a general power to exempt 
experiments from the NIH guidelines without designating in regard 
to whom a “significant risk” should be evaluated. The Secretary might 
find that containment at a laboratory is sufficient enough that no “sig- 
nificant risk” is posed for the surrounding community. However, there 
is nothing in the law which addresses the significant risk which may 
be created for laboratory workers or graduate students engaged in 
recombinant DNA experiments. 
[Appendix B — 170] 
