3. Adequate techniques for environmental 
monitoring for recombinant DNA molecules 
do not exist. So that with neither accurate 
biological monitoring nor adequate environ- 
mental monitoring, the ascertainment of the 
level of worker exposure to recombinant DNA 
material is impossible. 
4. Contrary to the statement in the July 28, 1978 
Federal Register (p. 33065) that "OSHA stan- 
dards and procedures apply to most institutions," 
OSHA regulations do not apply to University and 
Federal reseaich laboratories, where much of 
the recombinant DNA research is being done. 
Thus many of the workers who face hazardous and unpredictable 
exposures to recombinant DNA molecules are not protected by OSHA. 
And they are not protected under the proposed Revised NIH Guide- 
lines. 
1. The "Guidelines" are simply guidelines. They 
do not have the force of law behind them. 
They provide for sanctions that are inadequate 
to ensure compliance. To wit : (p. 33087, 
IV-D-l-(a), "noncompliance may result in 
suspension, limitation or termination of 
financial assistance for such projects...." 
2. The Guidelines do not apply to industry. To 
compound this error of omission is the notor- 
ious problem in industrial research of large 
scale production. And as commercial use 
increases; production will increase; job 
speed-up will result; accidents will increase; 
and hazardous exposures will increase. 
3. The Guidelines are inadequate in their specifi- 
cation for biological monitoring or medical 
surveillance: (p. 33084, IV-A-l-(c)). The 
institution would be given responsibility for 
the determination "in connection with each 
project, the necessity for medical surveillance 
of recombinant DNA research personnel." Thus, 
a. The institution may determine that 
medical surveillance is unnecessary. 
b. The stipulation is for "research 
personnel" only. It ignores 
maintenance and janitorial staff, 
and the families of exposed workers. 
c. The requirements are too nonspecific 
and leave too much to the discretion 
of the individual institution. 
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