s 13318 CONGRESSIONAL RECORD — SENATE August 2, 197? 
and the National Society for Medical Re- 
search. 
Thirteen members of the National Acad- 
emy of Sciences signed a resolution as fol- 
lows: 
Resolution or the National Academy or 
Sciences, Ateil 26, 1927 
Three years ago the National Academy of 
Sciences played an Important role In Initiat- 
ing responsible and Informed discussion on 
the need for controls and recombinant DNA 
research. The subsequent debate, both In- 
side and outside the scientific community, 
resulted In a set of guidelines formulated 
under the sponsorship of the National In- 
stitutes of Health. Now the Congress Is con- 
sidering several drafts of detailed and far 
reaching legislation dealing with the regul- 
ation of recombinant DNA research. 
The NTH guidelines are the result of care- 
ful deliberation and we favor their simple 
conversion Into a uniform national set of 
regulations. However, much of the proposed 
legislation now before Congress would allow 
local communities or states to set their own 
stricter regulations. Including even a com- 
plete ban on this type of research. It Is rea- 
sonable for the local community to partici- 
pate In supervising adherence to regulations. 
But the question concerns speculative rather 
than known dangers and these would not 
vary from one locality to another. 
The research Institutions of the country 
constitute an Important national resource, 
and differing local options could subject that 
resource to arbitrary regulations. Overly re- 
stricting this type of research would severely 
degrade the capability of biomedical research 
and limit Its contribution to the public wel- 
fare. In essence, It would allow a local com- 
munity to affect a critical component of na- 
tional policy. Above all, local option would 
set a dangerous pattern for the regulation of 
basic research In a manner that might de- 
prive society of substantial future benefits. 
Some of the legislation proposes to estab- 
lish a national regulatory commission ex- 
pressly to govern recombinant DNA research. 
Its broad powers for controlling basic re- 
search represent a wholly new and unfortu- 
nate departure. We are also concerned that 
it would set a precedent for the regulation 
of other areas of science. A much simpler and 
more flexible mechanism allowing for public 
participation could carry out those functions 
that may be needed. 
Therefore, be It resolved that we voice 
concern about legislative developments In 
this area and ask the president of the Na- 
tional Academy of Sciences to relay these 
concerns to appropriate officials In the gov- 
ernment. 
D. Baltimore. B. D. Davis, H. Eagle. J. T. 
Edsall, C. Grobsteln, D. M. Horstmann, R. 
Hotchkiss, R. J. Huebner, A. Rich, W. A. 
Rosenbllth, P. N. Ruddle, B. L. Slnshelmer. 
E. L. Smith. 
Thus, while I agree with the Intent of 
8 . 1217, I have serious reservations about Its 
approach, based on scientists' concerns that 
It will Impose unnecessarily burdensome con- 
trols on scientific research. My concerns are 
as follows: 
(1) Commission.— The bill will create a 
new and expensive bureaucracy that Is un- 
warranted. 
Section 1801 of 8. 1217 establishes an In- 
dependent Commission to license, regulate 
and make policy decisions regarding recom- 
binant DNA activities. Members would be 
appointed by the President, with Senate ap- 
proval for the Commission Chairman. A 
majority of the members would be public, 
nonscientists. Section 1801(b) prohibits a 
majority of members on the Commission 
who are or have been engaged In recombinant 
DNA research. This would severely limit the 
expertise of a Commission whose major pur- 
pose Is to protect health and safety from 
untoward effects of such research. 
Furthermore, all members would have 
other primary responsibilities besides their 
Commission activities. Given the number 
and the highly technical nature of the as- 
signed tasks, such a part-time Commission 
would be unworkable, in my view. Section 
1816(e) permits the Commission to delegate 
technical matters to Its staff or to ad hoc 
working groups; however. I do not believe 
It Is our Intent to delegate these Important 
duties to staff. An Important question also 
arises as to who actually would be account- 
able for the regulatory activities of such a 
free-standing Commission. 
Section 361 of the Public Health Service 
Act already provides HEW with the following 
broad authority to regulate laboratory work 
with disease-producing microorganisms: 
"The Surgeon General with the approval 
of the Secretary Is authorized to make and 
enforce such regulations as In hts Judgment 
are necessary to prevent the introduction, 
transmission or spread of communicable dis- 
eases from foreign countries Into the states or 
possessions or from one state or possession 
Into any other state or possession.” 
Under thl3 statute, the Center for Disease 
Control has established regulations for con- 
tainment and requirements for. working with 
different classes of organisms, Including total 
prohibition on work with a few lethal micro- 
organisms. As a result, there have been very 
few cases of laboratory-associated Infection 
In the history of the United States and none 
that have spread to the community. 
Existing law also provides HEW with au- 
thority to regulate private and public Inter- 
state clinical laboratories (Clinical Labora- 
tories Improvement Act of 1967, Public Law 
90-174) and legislation is being considered 
to broaden HEW's regulatory authority to 
Intrastate clinical laboratories. This author- 
ity will not cover biomedical research nor 
Is It my Intent that It should, but as with 
the above-mentioned authority to regulate 
laboratory work with disease-producing or- 
ganisms, It can provide an alternative mech- 
anism In place for monitoring compliance 
with the guidelines for recombinant DNA 
activities. 
Finally, the NIH has an administrative 
mechanism In place to Implement Its guide- 
lines on recombinant DNA activities. 
Therefore, a simple extension of HEW’s 
authority to allow for enforcement of DNA 
guidelines In the private sector would ac- 
complish the objective of establishing uni- 
form national guidelines for recombinant 
DNA activities. 
(2) Penalties. — Section 1809 establishes 
penalties for noncompliance, for "any per- 
son who knowingly, willfully or negligently” 
violates a provision of section 1803, general 
requirements and section 1808, prohibited 
acts. It authorizes a penalty of 810,000 for 
each violation with each day constituting 
a separate violation. 
The term "negligence” Is not clearly de- 
fined. Such a penalty also appears to be 
excessive and disproportionate. License revo- 
cation In Itself Is an effective penalty. Fur- 
thermore a dollar penalty would not deter 
those who wish to willfully disregard regu- 
lations. In short, we run the risk of enacting 
legislation which will obstruct the law-abid- 
ing while not effectively deterring the law- 
breaker. 
(3) Seizure and destruction of research 
material. — Section 1810 gives Inspectors au- 
thority to seize and destroy "a hazardous 
product of recombinant DNA activities” with 
the approval of the Commission Chairman 
or his designee. A better procedure would 
be to seize and hold material pending a Ju- 
dicial hearing. 
(4) Preemption. — On the whole. I support 
Section 1813, which expresses Congressional 
Intent that Federal Guidelines supersede any 
and all laws regarding recombinant DNA ac- 
tivities of States and of political subdivisions. 
I believe, however, that the granting of ex- 
emptions should take Into account the na- 
tional Interest. The purpose of legislation 
should be to establish uniform national 
standards to regulate recombinant DNA ac- 
tivities; otherwise, legislation is not neces- 
sary. Since microbes do not respect Federal, 
State, or community boundaries, the most 
effective standards will be those adopted 
Internationally. 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 en- 
vironment of their local communities. How- 
ever, 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 require- 
ments for DNA research as necessary to pro- 
tect 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 la 
the general Federal guidelines, rather than 
grant Individual exemptions from them. 
(5) Disclosure of research details. — De- 
tailed descriptions of recombinant DNA pro- 
jects 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) (11)), and registration of DNA proj- 
ects (sec. 1818(a)). Such detailed descrip- 
tions of research protocols would thus be 
given to local biohazard committees: to the 
Commission for licensure; and to the Com- 
mission for purposes of registering each re- 
search project. Section 1803(c) requires the 
Commission to publish such Information In 
the Federal Register with each license ap- 
plication. 
The requirements Impose enormous paper- 
work burdens on researchers. In addition, 
although Section 1817 contains certain ex- 
emptions from disclosure. It Is not clear 
that It will protect the research protocols, 
designs, and hypotheses of academic and In- 
dustry researchers. In a recent court ruling 
relating to subsection (a) of section 552 o 1 
title 5, United States Code (b) (4) (Free- 
dom of Information Act). HEW was ordered 
to release research protocols on grounds they 
were not trade secrets (Washington Re- 
search Project, Inc. v. DHEW) . A statute 
affording positive protection, therefore, for 
Intellectual property rights associated with 
recombinant DNA activities should be devel- 
oped In accordance with subsection (b) (3) 
of the Freedom of Information Act (FOIA). 
(6) " Sunset ” provision. — There should be 
a "sunset" provision that requires review of 
the need for the legislation after a reason- 
able time period. 
(7) Impact oh small business. — The paper- 
work and compliance requirements of the 
legislation will be particularly difficult for 
small companies to meet, putting them at 
competitive disadvantages with large In- 
dustries. Compliance with the NIH Guide- 
lines already has Imposed administrative 
burdens on small laboratories, although they 
are able to meet the requirements. 
In summary. I must dissent from the deci- 
sion of the Committee to recommend pas- 
sage of 8. 1217 as reported. Appropriate leg- 
islation to allow the application of uniform 
Guidelines bv HEW to all sectors will en- 
able the United States to negotiate for In- 
ternational guidelines for recombinant DNA 
activities. 
S. 1217, however, sets a bad precedent for 
future restrictive regulation of biomedical 
research in general. The compliance pro- 
visions and paperwork are excessive, possi- 
bly unworkable, and particularly burden- 
some for small businesses. The potential for^ 
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