DISSENTING VIEWS OF REPRESENTATIVES HENRY 
A. WAXMAN, BARBARA A. MIKtJLSKI, ANDREW 
MAGUIRE, EDWRD J. MARKEY, MARC L. MARKS, AND 
RICHARD L. OTTINGER. 
We are extremely disappointed that H.R. 11192 makes virtually no 
provision for public participation in regulation of recombinant DNA 
research. The bill unnecessarily mandates Federal preemption of State 
and local regulation unless these governmental units can meet the 
heavy burden of proving the “necessity” of their own regulations. 
Almost total discretion is given to the Secretary of Health, Educa- 
tion, and Welfare to exempt DNA research from Federal regulation 
by order, without the benefit of any public rulemaking proceeding. Be- 
cause of these defects in the bill, we must respectfully dissent from the 
report of the Committee. 
I. ABSENCE OF STATUTORY REQUIREMENTS FOR PUBLIC PARTICIPATION 
H.R. 11192 was introduced in the full Commerce Committee as a 
substitute for H.R. 7897, a bill reported by the Health and Environ- 
ment Subcommittee after extensive hearings and Subcommittee delib- 
eration. In H.R. 11192, a number of requirements for public participa- 
tion which had been included in the Subcommittee’s bill have been 
eliminated. 
The subcommittee bill would have established by statute a “Re- 
combinant DNA Advisoiy Committee” of 17 members, of whom at 
least nine were to be individuals not engaged in recombinant DNA re- 
search. Included in the tasks given to the Advisory Committee was 
the responsibility to advise the Secretary regarding the type of regula- 
tions promulgated under the Act. This Advisory Committee has been 
eliminated in H.R. 11192. 
The subcommittee bill had also required establishment of a “Local 
Biohazards Committee” in each community where DNA research is 
to be conducted. Representatives of the public interest were specified 
by the Subcommittee bill to be members of such Committees. “Local 
Biohazards Committees” are not required by the language of H.R. 
11192. 
Section 102(d) of H.R. 11192 authorizes but does not require the 
Secretary to establish “local entities to assist in administration and 
enforcement” of the Federal regulations to be promulgated under 
section 102(a) (1). 
It does not appear that these “local entities” will be anything more 
than institutional peer review committees, with corporations or edu- 
cational institutions conducting DNA research in essence policing 
themselves. There is no requirement that representatives of local gov- 
ernments or citizen interest groups be made members of these “enti- 
ties,” nor is there any requirement that such representatives, if ap- 
pointed, be given a vote in “entity” deliberations. 
(35) 
[Appendix B — 165] 
