02 
political subdivisions. I believe, however, that the granting of exemp- 
tions should take into account the national interest. The purpose of 
legislation should be to establish uniform national standards to regu- 
late recombinant DMA activities; otherwise, legislation is not neces- 
sary. Since microbes do not respect Federal, State, or community 
boundaries, the most effective standards will be those adopted inter- 
nationally. If we are to negotiate for international standards, we must 
have good uniform national standards, not a potpourri of domestic 
standards. 
Citizens should have input into decisions regarding protection of 
the health and environment of their local communities. However, the 
authority to grant exemptions should be at the Secretary’s discretion, 
based on clear demonstration that the public health and environment 
is endangered. If a locality proposes more stringent requirements for 
DXA research as necessary to protect health and environment, it is 
likely that other communities would require it; thus, the Secretary 
should evaluate the need for inclusion of more stringent requirements 
in the general Federal guidelines, rather than grant individual exemp- 
tions from them. 
(5) Disclosure of research details. — Detailed descriptions of recom- 
binant DXA projects are required to be reported at three places in the 
bill: General requirements and licensure (secs. 1803(b)(1)(C) and 
1803(b) (2) (A) (ii) ) : and registration of DXA projects (sec. 1818 
(a)). Such detailed descriptions of research protocols would thus lie 
given to local biohazard committees; to the Commission for licensure; 
and to the Commission for purposes of registering each research 
project. Section 1803(c) requires the Commission to publish such in- 
formation in the Federal Register with each license application. 
The requirements impose enormous paperwork burdens on research- 
ers. In addition, although Section 1817 contains certain exemptions 
from disclosure, it is not clear that it will protect the research proto- 
cols. designs, and hypotheses of academic and industry researchers. In 
a recent court ruling relating to subsection (a) of section 552 of title 5, 
United States Code (b)(1) (Freedom of Information Act). HEW 
was ordered to release research protocols on grounds they were not 
trade secrets (Washington Desearch Project. Inc. v. DREW) . A stat- 
ute affording positive protection, therefore, for intellectual property 
rights associated with recombinant DXA activities should be devel- 
oped in accordance with subsection (b)(3) of the Freedom of Infor- 
mation Act (FOIA) . 
(6) u Sunset'' provision. — There should be a “sunset” provision that 
requires review of the need for the legislation after a reasonable time 
period. 
(7) Impact on small business. — The paperwork and compliance 
requirements of the legislation will be particularly difficult for small 
companies to meet, putting them at competitive disadvantages with 
large industries. Compliance with the XTH Guidelines already has 
imposed administrative burdens on small laboratories, although they 
are able to meet the requirements. 
In summary, I must dissent from the decision of the Committee to 
recommend passage of S. 1217 as reported. Appropriate legislation to 
allow the application of uniform Guidelines by HEW to all sectors 
will enable the United States to negotiate for international guidelines 
for recombinant DXA activities. 
[ 302 ] 
