2,6 
an evolution of patchwork regulation within governing jurisdictions 
of varying size (that is, city, county, State, etc.) which in his opinion 
would be an intolerable situation for the scientific community. (This 
assumes that each jurisdiction would develop nuances of differences 
in their own approach to regulation.) If it is true that no existing 
Federal laws will permit regulation of this area of laboratory research 
then he feels that the Congress should construct such legislation at 
the Federal Wei, once it determines that legislation is needed. 
E. Industry Views 
The guidelines are only enforceable as regulations at the present 
time on federally funded research. Although there has been a general 
indication that private firms would follow the guidelines voluntarily, 
there has been public concern about how such compliance would be 
assured. Further, some of the discussions regarding industry compli- 
ance have led to accusations that manufacturers could not be expected 
to follow the guidelines because of problems in dealing with trade 
secrets, patents, and limitations on quantities of materials permitted 
under the guidelines. John G. Adams, Vice President for Scientific 
and Professional Relations and Bruce J. Brennen, Vice President and 
General Counsel for the Pharmaceutical Manufacturers Association 
(PMA) provided their comments to the subcommittee 
Dr. Adams 
In his testimony, Dr. Adams indicated that three PMA firms were 
directly engaged in DNA recombinant molecule research and three 
other member firms were supporting academic research. All are com- 
mitted to voluntary compliance with the NIH guidelines. Dr. Adams 
also indicated that PMA had participated in discussions with NIH 
during and following the publication of the guidelines, as well as in 
discussions with the Department of Commerce. In all testimony 
before both House and Senate committees, the position of the PMA 
has remained unchanged. Although the member organizations are 
committed to voluntary compliance with the NIH guidelines, the 
guidelines were written exclusively for research organizations, there- 
fore there are some adjustments which will be required in the operative 
portion of the guidelines in order for the technology to be used com- 
mercially. Their concerns relate primarily to administrative features 
and not to a desire to reduce either the biological or physical contain- 
ment features of the guidelines. Points of particular concern include 
the need for protecting the confidentiality of information submitted 
to the Government in compliance with requirements for inspection and 
reporting and a concern about the limitations on the volume of cultures 
prescribed in the guidelines. Commercial practices would necessitate 
the use of larger volumes for scaleup of any process of commerical 
importance. 
Federal Prescription 
According to Dr. Adams, the Association advocates Federal legisla- 
tion and supports licensing and inspection of facilities, registration of 
research projects, and mandatory submission of reports. Member 
firms also endorse the promulgation of regulations based on the exist- 
ing NIH guidelines to make them applicable to all persons engaged in 
[Appendix B — 75] 
