KANT
AML

THE ROCKEFELLER UNIVERS ITY
ro bono humani generis
1230 YORK AVENUE - NEW YORE. NEW YORK 10021-6399

Joshua Lederberg
UNIVERSITY PROFESSOR

CO PY June 19, 1995

Thomas A. Daschle

Senate Minority Leader

SH-317 Hart Senate Office Building
Washington, D.C. 20510-4103
facs:(202) 224-2047

Dear Senator Daschle:

I am writing to express my concern about the comprehensive Regulatory Reform Act of
1995. Used wisely, risk assessment, comparative risk analysis, cost-effectiveness analysis,
and cost- benefit analysis can provide useful information to decision-makers on issues
affecting health, safety, and the environment. I have long been a strenuous advocate of the
systematic use of such tools. However, I would caution against a peremptory mandate for the
routine use of such tools in environmental regulation until we gain greater knowledge and
experience.

Specifically, in many cases language entailing the "best estimate" of risk or the "most
plausible level" of risk overreaches our current level of scientific understanding. Of course, I
support legislation intended to improve the scientific basis for and transparency of risk
assessments. But that goal is contradicted by reducing funding for scientific research that
addresses the biological bases of risk assessments. Likewise, substantial support (and time)
is needed for research and training on risk assessment techniques - expanding the number and
sophistication of risk assessments will require additional training of practitioners. In addition,
while I agree that peer review is an important quality assurance mechanism, peer reviewers
without conflicts of interest and with sufficient knowledge are a limited resource; peer review
programs should be conducted with an eye to reasonable feasibility, within agency resource
constraints and commensurate with the level of scientific importance and regulatory impact.
Regulatory decisions may be greatly improved by good risk assessments, but good risk
assessments alone do not ensure good regulatory decisions. Risk assessment is not an end in
itself: it should be an adjunct to the primary goal of safeguarding public health and the
environment.

Please feel free to contact me if you would like more detailed comments on the draft
regulatory reform legislation.

Yours sincerely,

Joshua Lederberg
(Member, Risk Assessment and Management Commission)

Address also to

Robert J. Dole

Senate Majority Leader

SH-141 Hart Senate Office Building
Washington, D.C. 20510-1601
facs:(202) 228-1245

Copy to

Alice M. Rivlin

Deputy Director

Office of Management and Budget
Old Executive Office Building
Washington, D.C. 20503
facs:(202) 395-3746

John H. Gibbons

Director

Office of Science and Technology Policy
Old Executive Office Building
Washington, D.C. 20500

facs:(202) 395-3261