4 
"...would more probably be using quantities of viruses greater 
than the quantities needed for diagnostic purposes. The CDC 
classification is based on the use of diagnostic quantities." 
With these modifications, Mr. Mitchell seconded the motion. By a vote o f 
fourteen in favor, none opposed, and no abstentions, the minutes of the 
June 28, 1982, RAC meeting were adopted. 
III. CDC/NIOSH DRAFT REPORT ON MEDICAL SURVEILLANCE 
Dr. McKinney introduced the CDC/NIOSH (Centers for Disease Control/National 
Institute for Occupational Safety and Health) report on medical surveillance 
(tab 1082) entitled "Medical Surveillance of Biotechnology Workers: 
Report of the CDC/NIOSH ad hoc Working Group on Medical Surveillance for 
Industrial Applications of Biotechnology." Dr. McKinney said the CDC/NIOSH 
report had been discussed by the Large-Scale Review Working Group of the 
Recombinant DMA Advisory Committee (tab 1088) on two separate occasions, 
in February and in June 1982. Ihe key issue in those discussions was 
whether technology employing recombinant ENA techniques should be singled 
out from the biotechnology industry in general for medical surveillance 
programs. 
Dr. McKinney said that he personally felt it inappropriate to dictate a 
specific medical surveillance program. However, the CDC/NIOSH report does 
point out what needs to be considered in medical surveillance programs. 
Dr. McKinney suggested that the thanks of the RAC be conveyed to the 
CDC/NICSH working group. He also suggested the report be considered for 
publication in the Recombinant ENA Technical Bulletin , as an article which 
conveys some thoughts about medical surveillance. 
Dr. McGarrity said he had two questions: (1) is "follow-up" of workers 
absent for more than 48 hours standard procedure, and. (2) were illnesses 
due to exposure to bacterial enzymes or products due to a chronic, con- 
tinuous type of exposure or due to an accidental, single burst of exposure? 
Dr. McKinney said the choice of 48 hours is arbitrary; workers absent for 
illnesses of 72 hours could also have been chosen for "follow-up." In 
response to the second question, he said the report dealt with chronic 
exposures to bacterial products. He said this type of exposure might be 
classified as chemical exposure. 
Dr. Nightingale questioned whether RAC should make any formal reccmmen- 
dation concerning the CDC/NIOSH report. Dr. Talbot said NIOSH would 
determine what they would do with the report. The RAC could recommend 
whether the NIH should do anything with it. 
Dr. Nightingale noted that the report is an information document. She 
questioned the appropriateness, in that context, of the Large-Scale Review 
Working Group having forwarded to RAC the CDC/NIOSH report with an attached 
resolution. Dr. Berns explained that the Large-Scale Review Working Group 
overwhelmingly passed the motion to accept and send to RAC the CDC/NIOSH 
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