28 
then he is bound by law to grafit an exemption from subsection (a) 
for these specific provisions. That is, the Secretary has discretionary 
powers in making the judgment as to whether or not a proposed re- 
quirement is necessary to protect health or the environment, and this 
decision should be based upon the best available scientific and risk 
assessment data. However ^ if he should decide that a State or local gov- 
ernment has proven its case, then he shall grant an exemption to the 
provision that the Federal requirements supercede all State and local 
requirements. It is the committee’s intent that all such decisions be 
based purely upon health and safety considerations and, thus, there 
should be no discretionary powers granted tor the Secretary where a. 
decision could be made upon other, less relevant grounds. 
The Secretary must approve or disapprove the application within 
either 60 days from the conclusion of the hearing or one hundred twen- 
ty days from the date of the application, whichever occurs later. The 
Secretary’s decision shall be in writing, contain the presiding officer’s 
recommendation if a hearing was held, and shall include a complete 
discussion of the reasons for the decision. 
SECTION 107 TRAINING AND STUDIES 
107(a) Training courses in the safe handling of recombinant DNA 
The Secretary is authorized to conduct and support training courses 
and workshops to instruct personnel to be engaged in recombinant 
DNA activities in any relevant safety procedure or technique. Such 
courses might be set up under the auspices of the National Institutes of 
Health or the Center for Disease Control, for example. The Secretary 
may also provide grants to institutions or to local biohazards commit- 
tees to set up and conduct training programs where justified by local 
needs. 
The committee believes that the proper training of personnel is es- 
sential to the success and effectiveness of the Recombinant DNA Act. 
It is, therefore, expected that the Secretary will give the training of 
personnel high priority in administering the provisions of this Act. 
107(b) Risk assessment studies 
The Secretary is required to conduct and support “on a continuing 
basis” studies designed to evaluate the risks to health and the envi- 
ronment which may be presented by recombinant DNA activities. 
This should include the financial support of specific experiments 
designed to evaluate hazards, such as that being jplarinM'at 1 the Na- 
tional Institutes of Health by Drs. Malcolm Martin and Wallace 
Rowe to assess the probability of transferring tumor virus genes to 
mice via E. coli K-12, as well as risk assessment workshops such as 
that held in Falmouth, Mass., on June 21-22, 1977. Such studies and 
programs are essential in making sure that the safety regulations 
contained within the Recombinant DNA Act accurately reflect the 
best possible evaluation of the actual risks posed by any particular 
recombinant DNA activity. It is wasteful and burdensome to the 
investigator and the Government to continue in effect requirements 
which have been shown to be overly stringent to provide adequate 
protection of health and the environment for a specific recombinant 
[Appendix B — 158] 
