Director 
National Institutes of Health 
- 2 - 
September 18, 1978 
3. The Guidelines do not establish a central clearing house which would 
record and monitor the nature and kind of organisms being used in 
recombinant DNA work and collect data regarding the safety record of 
particular laboratories. 
Recommendation 
Require an appropriate agency within NIH and a State affiliate of the 
California Department of Health Services or Cal-OSHA to maintain such 
data, including accurate records of workers in recombinant DNA work, 
with particular regard to the incidence and severity of possible work 
related illness; or, require that special reporting requirements be met 
by research laboratories with their respective Biosafety Committees, 
who in turn will file reports with State or local agencies. 
4. While the new proposed guidelines acknowledge the problem of certifica- 
tion (page 33132) and considerable more input from laboratory health 
experts, they still do not require the special training procedures which 
are now standard for certain laboratories doing work with pathogenic 
organisms . 
Recommendation 
Specify that lab workers in P2 and higher facilities take and pass cer- 
tain training courses, or demonstrate equivalent competency, prior to 
working directly with recombinant DNA organisms. A centralized and 
uniform certification process would be extremely desirable for P3 and 
P4 level workers. The State presently has such a program, and has the 
requisite expertise (Dr. Edwin Lennette) to organize and conduct State- 
wide training. 
5. The policy on noncompliance is vague and weak. It invites too much 
latitude in defining penalties by encouraging discretion to be used, 
from exoneration to full penalties, without mention of due process to 
injuried parties, particular-y workers. 
Recommendation 
Section IV-D-l-b on Page 33087, remove the word "may" and replace with 
"shall ... upon an affirmative finding after due process, that a will- 
ful violation has in fact occurred." Negligence may result in similar 
suspension, limitation, or termination of NIH funds. It should also 
be stated that federal action does not preclude state action where 
activities in question violate state statutes or regulations. 
[A-167] 
