Section 105 of H.R. 11192 allows the Secretary to designate indi- 
viduals to be inspectors for the purposes of enforcing the act’s require- 
ments. No standards for selecting such inspectors are stated, other than 
that an inspector must not be conducting or have a direct financial 
interest in DNA research. This section allows for the possibility that 
an employee of an institution conducting DNA research can be desig- 
nated as an inspector of the research activity at that same institution. 
When coupled with the vague language regarding the local “entities” 
to be established, the resulting situation is that DNA research could 
be conducted without any public involvement in regulation and without 
any direct Federal safety review. The public health and the en- 
vironment are not protected by this regulatory scheme, which allows 
private institutions to define the public interest. 
The subcommittee bill provided in section 473 (e) for citizen petitions 
to the Secretary to initiate rulemaking proceedings. This provision, 
which allowed the people to be involved in a significant way in HEW’s 
regulatory activity, has been eliminated in H.R. 11192. 
Section 201 of H.R. 11192 establishes a Commission for the Study 
of Research and Technology Involving Genetic Manipulation. Al- 
though this section includes a lengthy list of professions from which 
Commission members may be selected, there is no specific requirement 
for designation of members representing public interest or citizen 
groups. Total discretion is given to the Secretary, who could, if he so 
desired, appoint only scientists to the Commission. There is no restric- 
tion on the number of individuals involved in genetic research who 
may be appointed to the Commission. 
The effect of the deletions and variations from the subcommittee 
bill, as well as the vague criteria for Commission membership, is that 
mandatory involvement of the citizenry in rulemaking, local enforce- 
ment, and study of research issues at the national level is absent from 
H.R. 11192. 
In committee debate on this measure, proponents of H.R. 11192 
offered virtually no rationale for the glaringly evident lack of provi- 
sion for public participation. 
In the committee’s earlier debate on the Subcommittee bill, only 
limited opposition had been raised to the public involvement require- 
ments eliminated in H.R. 11192. Opponents of these requirements 
expressed the view that even limited citizen involvement in regulation 
might be inappropriate when related to research activity, particularly 
if such involvement resulted in placing limits on that research. 
We totally reject the view that the people are incapable or unworthy 
of conducting public business, and that only a regulatory or research 
elite can make reasoned decisions on the complex regulatory issues of 
the day. 
H.R. 11192 as reported by the committee essentially leaves all 
regulation of DNA research activity in the hands of the corporations 
and universities undertaking such research, and in the hands of HEW’s 
National Institutes of Health (NIH), the chief Federal advocate for 
such research. 
NIH is the Federal government’s primary biomedical funding 
agency. In this position, it plays what can be described as a “promo- 
tional” role in the research community. H.R. 11192 places NIH, 
through the Secretary, in the position of being both promoter and 
[Appendix B — 166] 
