6 
Ihese regulations are an attentpt to reduce the indiscriminate disposal 
of toxic chemical waste in the environment. 
Dr. Bems said he found the CDC's proposed biosafety guidelines for 
etiological agents, with regard to some of the specific ccxitainment levels 
suggested, to be capricious and unscientific, and the CDC unresponsive to 
expressed concerns. He admitted that the guidelines may be ^ jure , 
voluntary, but feared they would not be voluntary, ^ facto . 
Dr. Williams, vhile admitting that the CDC guidelines and OSHA regulations 
were important, urged that the RAC resist the temptation to address a 
variety of issues beyond its charge. Mr. Thornton sipported this position. 
Mr. Thornton asked for a straw vote to gauge RAC sentiment. He first 
asked how many RAC members preferred to maintain the status quo regarding 
Section III-O. No one favored this approach. He then asked how many 
favored doing something to materially reduce or eliminate the paperwork 
and reporting functions for experiments covered by Section III-O. Nine- 
teen individuals supported this position. He then asked how many meidsers 
felt serious consideration should be given to exenpting entirely from 
the Guidelines, experiments currently covered by Section III-O. Ten 
members supported this position. Mr. Thornton asked NIH staff to prepare 
language on a series of options for publication in the Federal Register 
prior to the ^pril meeting. 
Dr. Campbell suggested that experiments currently covered by Section 
III-O be exempt from the Guidelines, but the Guidelines include a recom- 
mendation that these experiments be done under PI containment conditions. 
Dr. KrimsJy asked for a clarification of the mechanism by which funds are 
earmarked for evaluations. Dr. Talbot replied that Congress ^prcpriates 
budgetary funds for each Institute of the National Institutes of Health. 
A separate law specifies that up to one percent of those funds may be 
allocated to evaluation. A detailed review procedure within EHHS is 
used to allocate these funds among specific evaluation projects. 
IV. UPDATE OF PROPOSED RISK ASSESSMENT PROGRAM AND REVIEW OF PAPER ON E. COLI 
POPULATIONS 
Dr. Williams reviewed the Proposed First Annual l^ate of the Program to 
Assess Risks of Recombinant DNA Research (tab 962). Dr. Williams high- 
lighted some of the items discussed in the plan, including the protocols 
that originated in the Falmouth workshop concerning colonization by 
E. coli K-12 and transmission of genetic information from ^ coli K-12 
to the intestinal flora, and the protocol involving the ^ coli strain 
HS, a good colonizer, and plasmid pBR325. The plan also discusses the 
/' 
[34] 
