17 
Premature disclosure of such information is of great concern to 
both the nonprofit as well as commercial interests. Although there is 
no question that the interest of public health and safety are paramount, 
the “lisk/benefit equation" will not be meaningfully balanced in the 
public interest if adequate protection of confidential is not provided. 
As discussed above, such information may have real or potential 
patent value both for nonprofit as well as commercial entities and un- 
timely release could make it virtually impossible to obtain patents in 
the United States or in foreign countries. In other cases the research 
protocols or results are the most important asset of the laboratory sci- 
entist — the “intellectual capital" upon which future grant or contract 
applications, or publications affecting his career, depend. 
Under the provisions of H.R. 11192. premature disclosure could oc- 
cur in a number of ways, depending on the nature of the regulations 
eventually promulgated by the Secretary. For example, it conceivably 
might occur in registration of research protocols, through inspections, 
through availability of information to members of biosafety com- 
mittees, through the activities of the Commission, and the like. It is im- 
portant to note that in all such instances the applicability of 18 U.S.C. 
1905 is clear. This Federal statute prohibits the release by any employee 
of the Federal government of “trade secrets, processes, operations or 
apparatus” obtained pursuant to this bill. It is only because of the ex- 
istence of this provision that it is unnecessary to write any additional 
provision into the legislation. In fact, if it were not for the protection 
afforded by 18 U.S.C. 1905 there would clearly have been a need to 
put an additional provision into the legislation. 
Following publication of proposed regulations in the Federal Reg- 
ister, “the Secretary shall give interested persons an opportunity to 
submit written data, views, or arguments on such regulations and may 
provide opportunity for the oral presentation of views and argu- 
ments.” Because of the special concerns and interests of industry, the 
term “persons'" should clearly include commercial entities conducting 
recombinant DXA research. 
Environmental Impact 
The Committee on Interstate and F oreign Commerce deleted a pro- 
vision within section 102 which would have made the provisions of the 
National Environmental Policy Act (XEPA) of 1969 inapplicable to 
any action taken by the Secretary under title I of the bill. The Com- 
mittee on Science and Technology agrees with the logic of this deci- 
sion and supports the action taken by the Commerce Committee as 
further discussed in its report. 
As pointed out during testimony by the Director of XIH before 
the subcommittee on April 11, 1978, to fulfill the XEPA requirement 
DHEW will conduct an assessment of the environmental impact of the 
standards and regulations (i.e., of the XIH Recombinant DXA Guide- 
lines) . The XIH will then, based on the assessment document, make 
a determination as to whether an Environmental Impact Statement 
(EIS) is required for a specific change in the standards and regula- 
tions being proposed. 
XIH dia file an environmental impact statement on the recombinant 
DXA Guidelines in October 1977 and is conducting an assessment of 
the environmental impact, if any, of the proposed revisions to the 
[Appendix B — 205] 
