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As you are aware, the Occupational Safety and Health Admin- 
istration (OSHA) does not currently have a specific standard 
governing the use of recombinant DNA . However, apart from 
the Act's requirement that employers comply with OSHA stand- 
ards, the Act additionally imposes upon employers a general 
duty to assure that employment and places of employment are 
free from recognized serious hazards (sec. 5(a)(1)). OSHA 
is particularly interested in the Guidelines in that they 
may prove helpful in identifying recognized serious hazards. 
In any event, guidelines are an additional means of provid- 
ing protection for those engaged in work under a grant 
program. 
In an effort to provide broad input to the revision of the 
Guidelines which were first issued on June 23, 1976, the NIH 
has coordinated the contributions of both the scientific and 
public communities in drafting the PRG's. In this way, OSHA 
has followed the revision of the Guidelines with great inter- 
est. We continue to actively participate in the study of 
federal regulation of this technology through our membership 
on the Interagency Committee on Recombinant DNA Research. As 
outlined at these meetings, our primary concern is to insure 
that workers involved in this research are adequately pro- 
tected under Federal guidelines, and that they are applied 
uniformly in all workplaces engaged in recombinant DNA 
research. In view of our established concern in this area, 
I submit the following comments concerning the PRG's. 
- The Guidelines state certain general principles, the 
first of which is that certain experiments may be judged, in 
the light of currently available information, to present such 
serious potential hazards, that they should not be attempted 
at the present time. This principle specifically states six 
prohibited experiments. A major proposed revision would give 
the Director of NIH the authority to grant exceptions to any 
of the six prohibitions, based upon the recommendation of 
the Recombinant DNA Advisory Committee (RAC). At the present 
time, OSHA is not represented on the RAC and would want to 
render advice to the Director should a waiver of a prohibi- 
tion be considered. Two areas are of particular concern to 
us: exceptions from any section for the purpose of risk 
assessment; and exceptions from Section I-D-6, which prevents 
large-scale experiments over 10 liters of culture. I urge you 
to require consultation with relevant research and regulatory 
agencies prior to the granting of any exceptions. 
- The PRG's include a new section entitled "Exemptions," 
which lists five types of experiments which would be exempt 
from the Guidelines and for which no registration with NIH 
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