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groups ; however, I do not believe it is our intent to delegate these im- 
portant duties to staff. An important question also arises as to who 
actually would be accountable for the regulatory activities of such a 
free-standing Commission. 
Section 361 of the Public Health Service Act already provides HE W 
with the following broad authority to regulate laboratory work with 
disease-producing microorganisms : 
The Surgeon General with the approval of the Secretary is 
authorized to make and enforce such regulations as in his 
judgment are necessary to prevent the introduction, trans- 
mission or spread of communicable diseases from foreign 
countries into the states or possessions or from one state or 
possession into any other state or possession. 
Under this statute, the Center for Disease Control has established 
regulations for containment and requirements for working with differ- 
ent classes of organisms, including total prohibition on work with a 
few lethal microorganisms. As a result, there have been very few cases 
of laboratory-associated infection in the history of the United States 
and none that have spread to the community. 
Existing law also provides HEW with authority to regulate private 
and public interstate clinical laboratories (Clinical Laboratories Im- 
provement Act of 1967, Public Law 90-174) and legislation is being 
considered to broaden HEW’s regulatory authority to intrastate clin- 
ical laboratories. This authority will not cover biomedical reseach nor 
is it my intent that it should, but as with the above-mentioned authority 
to regulate laboratory work with disease-producing organisms, it can 
provide an alternative mechanism in place for monitoring compliance 
with the guidelines for recombinant DNA activities. 
Finally, the NIH has an administrative mechanism in place to im- 
plement its guidelines on recombinant DNA activities. 
Therefore, a simple extension of HEW’s authority to allow for en- 
forcement of DNA guidelines in the private sector would accomplish 
the objective of establishing uniform national guidelines for recom- 
binant DNA activities. 
(2) Penalties . — Section 1809 establishes penalties for noncompli- 
ance, for “any person who knowingly, willfully or negligently” vio- 
lates a provision of section 1803, general requirements and section 1808, 
prohibited acts. It authorizes a penalty of $10,000 for each violation 
with each day constituting a separate violation. 
The term “negligence” is not clearly defined. Such a penalty also 
appears to be excessive and disproportionate. License revocation in 
itself is an effective penalty. Furthermore a dollar penalty would not 
deter those who wish to willfully disregard regulations. In short, we 
run the risk of enacting legislation which will obstruct the law-abiding 
while not effectively deterring the law-breaker. 
(3) Seizure and destruction of research material . — Section 1810 
gives inspectors authority to seize and destroy “a hazardous product 
of recombinant DNA activities” with the approval of the Commission 
Chairman or his designee. A better procedure would be to seize and 
hold material pending a judicial hearing. 
(4) Preemption .— On the whole, I support Section 1813, which ex- 
presses Congressional intent that Federal Guidelines supersede any 
and all laws regarding recombinant DNA activities of States, and of 
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