12 
potentially hazardous or infectious organisms. The Committee is con- 
cerned that brief or inadequate training in such techniques may in- 
crease the potential hazards posed by recombinant DXA activities 
and therefore places strong emphasis on the responsibility of licenses 
to ensure proper training of all personnel who will be working in the 
facility. 
TY. Additional Commission responsibilities 
The Committee believes that in order to properly do its job, the 
National Commission must be aware of the implications of the appli- 
cation of advances resulting from recombinant DXA research for 
individuals and for society; the laws and ethical principles govern- 
ing the use and potential applications of recombinant DXA technol- 
ogy ; the reasons why exemptions from F ederal preemption have been 
applied for and granted to states and political subdivisions; the im- 
plications of recombinant DXA activity within the field of genetic 
engineering; alternative approaches for assuring the safest and most 
appropriate applications and uses of recombinant DXA with regard 
to the protection of researchers and workers, the general public, and 
the environment ; possible alternatives to the definition in the law of 
recombinant DXA: and the status and extent of recombinant DXA 
activities conducted in exempted areas in the United States and in 
areas outside the United States. Thus, the Committee has required, 
within two years from the date of enactment, a comprehensive study 
be conducted to provide this information. Becaiise a significant com- 
ponent of the stud}’ focuses on the ethical and scientific principles 
which should underlie the conduct, applications, and uses of re- 
combinant DXA activity, the Committee believes that there is an 
important role to be played by the National Commission for the Pro- 
tection of Human Subjects of Biomedical and Behavioral Research. 
The Human Subjects Commission should have the opportunity to 
review and comment on the study proposal and the final report before 
it is issued by the recombinant DXA safety regulation commission. 
U II. License revocation, suspension or limitation 
It is. however, unavoidable in those cases where a license is revoked 
that all researchers, whether or not they are involved in the violation, 
are penalized. The Committee sees no alternative to this because of the 
inadvisability of individual licensing. However, license revocation is 
restricted to cases of willful, knowing or negligent violations of the 
most serious nature. For lesser violations, the Committee has provided 
for suspension or limitation of licensure. The Committee has also 
provided due process protection so as to assure that none of these ac- 
tions are arbitrarily applied. 
U II. Inspection , administrative restraint , seizure or destruction 
Only in extreme cases is seizure or destruction of material justified. 
In those instances and in order to fully safeguard the rights of the 
users of the material and to be sure that no adverse public health 
consequences result from the process of destruction of potentially 
hazardous material, the Commission is required to establish proce- 
dures which must include specific approval of any seizure or destruc- 
tion of material by the Chairman of the Committee or his designee. 
[ 752 ] 
