LARGE SCALE P3 LEVEL 
Page 6-VII-C-l-b: This requirement for changing of personal clothing and 
shoes is almost the full P4 specification except for the 
deletion of the requirement for a change of undergarments 
and .a slower each time an individual leaves the production 
area. In actual use, the operating staff in the production 
area would spend at least 10% of their work day frequently 
changing their clothing and shoes. Of more concern, the 
proposal is an excessively stringent specification and adds 
little to the lowering of risk. The existing laboratory P3 
specification, II-B-3-a-( 13) , is more than adequate if it 
can be broadened to include jump suits which would be 
removed before leaving the production area. Head covers in 
the hot production environment should also be deleted as 
they are also not required for laboratory P3 work. The 
requirements for personnel doing large scale P3 work should 
be no more stringent than laboratory P3 research, as the 
large scale P3 cultures must be previously approved by the 
RAC and the Director of NIH in addition to being 
"rigorously characterized and are shown to be free of 
harmful genes." This is not true for laboratory P3 
research which is potentially a higher risk. 
Page 7-VII-C-l-d: Although we have no intention of having persons under 
18 years of age in the P3 production area, why was the age 
specification increased from 16 years to 18 years old? The 
laboratory P4 minimum age is 18 year old compared to 16 
years for laboratory P3 research. Once again, the 
erroneous implicaton is that large scale P3 production is 
potentially more hazardous than laboratory P3 research. 
Page 8-VII-C-l-k: The phrase "except as necessary for access" should be 
inserted following the word "closed." 
Page 8-VII-C-l-o: We suggest that the phrase "validated procedures for 
inactivation of the organisms have been employed" be 
substituted for "inactivation of the organisms has been 
demonstrated." 
Page 8-VII-C-l-p: Insert the phrase "or disinfected by validated 
procedures" after the word "autoclaved." 
Page 9-VII-C-2-a: The specific requirement for HEPA filters should be 
modified to "filters capable of sterilization or equivalent 
procedure" such as incineration. 
Page 10-VII-C-2-b-(4) : The word "disassembly" should be deleted per our 
comment for Page 5-VII-B-2-b-(4) . 
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