Dr. William J. Gartland 
January 29, 1982 
Page 4 
environmental controls. In addition, at least insofar as the 
pharmaceutical industry is concerned, the initial products to be 
derived from recombinant DNA technology will be subject to the 
investigational new drug and new drug application review and 
approval procedures under Section 505 of the Federal Food, Drug, 
and Cosmetic Act. Consequently, any pharmaceutical products 
which become commercially available for health care will be 
reviewed for both safety and efficacy. 
Because of a continuing, recognizable level of public interest in 
recombinant DNA technology, we also acknowledge the desirability 
of maintaining the RAC. New developments in the field gradually 
move us closer to the need for answers to ethical and philoso- 
phical questions about applications of the technology. Other new 
findings may point to problems not yet conceived. A periodic 
review of the field by the RAC would certainly be in order. 
Further, with respect to long term safety considerations, it 
should be noted that representatives of federal agencies involved 
in environmental and public health matters participate in the 
activities of the RAC. Since both of the proposals under 
consideration would retain the RAC, the ad hoc representatives of 
various cabinet level and regulatory agencies would continue to 
serve. These individuals provide oversight, should safety 
concerns emerge. 
It also appears desirable for local institutions to assume primary 
responsibility for safety considerations. In this regard, Lilly 
urges the RAC, should it adopt the Baltimore/Campbell proposal, 
to recommend: 
1. the continuation of local Institutional Biosafety 
Committee activities in some form; 
2. appropriate training in laboratory procedures and 
safety for research laboratory, development, and 
production personnel involved in recombinant DNA 
technology. Adequate scientific standards - such as 
the guidelines - whether mandatory or voluntary, become 
meaningful and effective only if local personnel are 
adequately trained and appropriate institutional 
procedures are followed; and 
3. the issuing of a public statement pointing out the 
absence of any perceived need, on a scientific basis, 
for regulatory activity at the state or local level. 
[ 730 ] 
