Philip Morris
Delaney Clause - Linchpin of the Environmental Policy Edifice
Fields
- Author
- Singer, S.F.
- Document File
- 2502145956/2502146352/Thresholds 4
- Type
- REPT, REPORT, OTHER
- Area
- DEMPSEY,RUTH/OFFICE
- Named Organization
- Climate Convention
- Earth Summit
- Epa, Environmental Protection Agency
- Hew, Dept of Health Education and Welfare
- Intl Center for Scientific Ecology
- Natural Resources Defense Council
- US Congress
- 9th Circuit Court Appeals San Francisco
- Earth Summit
- Site
- E12
- Named Person
- Browner, C.M.
- Delaney
- Author (Organization)
- Science + Environmental Policy Project
- Master ID
- 2502146051/6295
Related Documents:- 2502146051 Paris Conference on Low Doses of Carcinogens
- 2502146065-6068 Is the Concept of Linear Relationship Between Dose and Effect Still A Valid Model for Assessing Risk Related to Low Doses of Carcinogens? 930510 - Paris
- 2502146069 the Causes and Prevention of Cancer Prof. Bruce N. Ames
- 2502146070-6071 the Causes and Prevention of Cancer
- 2502146072 How Biologically Based Models May Help Extrapolating Cancer Risk to Low Doses Prof. Georg Luebeck
- 2502146073-6079 How Biologically Based Models May Help Extrapolating Cancer Risk to Low Doses
- 2502146080 A Critical Study of Methods of Assessment of Effects of Low Doses Prof. Etienne Fournier
- 2502146081-6098 A Critical Study of Methods of Assessment of the Effects of Low Doses
- 2502146099 Do Rodent Studies Predict Human Cancers? Prof. Aaron Wildavsky
- 2502146100-6143 Do Rodent Studies Predict Human Cancers?
- 2502146144 the Delaney Clause-Linchpin of the Environmental Policy Edifice Prof. S. Fred Singer
- 2502146147 Toxic Policy at Dead End: the Case of Arsenic Prof. Gerhard Stohrer
- 2502146148-6153 Toxic Policy at Dead End: the Case of Arsenic
- 2502146154 the Asbestos Example Prof. J. Corbett Mcdonald
- 2502146155-6170 Linear Extrapolation for Risk Estimation at Low Level Exposure: the Asbestos Example
- 2502146171 the Case of Chlorine and Derivated Products Dr. Werner Freiesleben
- 2502146172-6185 the Case of Chlorine and Derivated Products (Vcm)
- 2502146186 the Ddt: Example Dr William Hazeltine
- 2502146187-6200 Is the Concept of A Linear Relationship Between Dose and Effect Still A Valid Model for Assessing Risks Related to Low Doses of Carcinogens - the D.D.T. Example.
- 2502146201 Test of the Linear-No Threshold Theory of Radiation Carcinogenesis Prof. Bernard L. Cohen
- 2502146202-6219 Test Linear-No Threshold Theory of Radiation Carcinogenesis
- 2502146220 Bladder Cancer in Rats Fed Sodium Saccharin Dr. Clifford I. Chappel
- 2502146221-6238 Bladder Cancer in Rats Fed Sodium Saccharin - Mechanistic Data and Their Application in Risk Analysis
- 2502146239 Environmental Tobacco Smoke and Lung Cancer Approaches to Risk Assessment Prof. P.N. Lee
- 2502146240-6270 Environmental Tobacco Smoke and Lung Cancer Approaches to Risk Assessment
- 2502146271 Endeavouring New Shores in the Estimation and Assessment of the Cancer Risk by Environmental Materials (Abstract) Pr Erich Hecker (As Pr. Hecker's Paper Arrived Too Late to Be Included in the Program of the Morning Session, It Will Be Presented in the Afternoon).
- 2502146272-6275 Endeavouring New Shores in the Estimation and Assessment of the Cancer Risk by Environmental Materials
- 2502146276 Special Papers Health Effects of Historical Exposures to Asbestos Exposure-Response: Asbestos and Mesothelioma Prof. Douglas Lidell
- 2502146277-6283 Health Effects of Historical Exposures to Asbestos
- 2502146284-6285 Exposure-Response: Asbestos and Mesothelioma
- 2502146286-6293 Threshold Levels Some Thoughts
- 2502146295
- Litigation
- Fali/Produced
- Date Loaded
- 21 Mar 2000
- UCSF Legacy ID
- bqp22d00
Document Images
Delaney Clause --Linchpin of the Environmental Policv Edifice
S. Fred Singer
Director, Science & Environmental Policy Project
Arlington, Virginia
A bright day may be dawning in the United States after several dark
decades of environmental policies based on unsubstantiated and
skewed science. After all, the acid rain legislation passed in
1990 simply ignored the results of the 10-year scientific study
that the US Congress itself had authorized and financed. The
current worldwide phase-out of chlorofluorocarbons and other useful
chemicals is a hasty operation based more on theoretical fears of
ozone depletion and skin cancer than on sound observations. And
the Climate Convention signed with great fanfare at the Rio de
Janeiro "Earth Summit" last June depicts a future global warming as
the greatest threat to the planet, in spite of absence of support-
ing data.
It is encouraging therefore to find that an icon which has lasted
35 years and wasted billions of dollars is about to fall. We are
talking here about the so-called Delaney Clause, more properly
Section 409 of the Food, Drug and Cosmetic Act, passed into law by
the U.S. Congress in 1958. It bans any food additive, including
the presence of pesticide residues, if they have caused cancer in
laboratory animals in tests where massive amounts Were adminis-
tered. In essence, it says that there is no safe dose, no
threshold below which health effects can be neglected. To put it
more dramatically: "One molecule can kill." No matter how small
the exposure to a potentially cancer-causing chemical, it must be
regarded as unacceptable as a food additive.
But what is zero? When the Delaney Clause became law, instruments
were not very sensitive; 50 parts per million would have been
considered zero. But in the past few decades technology has
advanced to the point where for some chemicals concentrations .as
much as a billion times smaller can be detected. Clearly the
meaning of "zero" has changed in a way that could not have been
foreseen by the author of the legislation.
The application of the Delaney Clause has caused a great deal of
mischief in the United States, and indeed throughout the world. In
1959, the U.S. Department of Health, Education, and Welfare halted
cranberry sales because of pesticide residues; thirty years later,
in 1989, the Alar scare decimated much of the U.S. apple-growing
industry. In between, we have had the ill-considered ban on DDT,
which permitted a resurgence of malaria with an annual death toll,
worldwide, of about 2 million. The scare about chemical wastes led
to the Love Canal debacle in New York State and the evacuation of

set at a lifetime cancer risk of 1 in a million, it would raise the
existing risk of 0.25 to 0.250001-- hardly a cancer epidemic.
But it is a legal, administrative matter that will finally kill the
Delaney Clause and the unrealistic and unscientific zero-risk
standard it prescribes. The Federal Insecticide, Fungicide, and
Rodenticide Act, the law governing the use of pesticides on farms,
does allow trace amounts of pesticides in food, even if the
particular compound causes cancer in test animals--clearly in
conflict with Delaney. Long-established drinking water standards
are also in conflict with the Delaney Clause. It would seem then
that the government should adopt a new policy, relaxing the Delaney
Clause, that would allow pesticide residues in all food, including
processed food, at such minimal levels. But when the U.S.
Environmental Protection Agency tried to put such a policy into
effect in 1988, it was sued by the Natural Resources Defense
Council, an activist environmental organization, notorious for
promoting the Alar scare. In 1992, the Ninth Circuit Court of
Appeals in San Francisco ruled in favor of the NRDC on the basis of
the Delaney Clause. EPA therefore had no choice but to follow the
law and limit or totally ban 35 compounds, many of them basic
pesticides used in agriculture.
It is at this point that the new EPA administrator, Carol M.
Browner, announced that perhaps changes in federal law might be
required. Such an action by Congress would be both unprecedented
and far-reaching. It would mark the first time that an existing
environmental policy has been changed because of better scientific
evidence. And such action on chemical cancer risk would have
corollary effects on the issues of cancer risk from asbestos and
radon. Most important, it would force re-examination of the
scientific basis for the Superfund legislation.
Like a house of cards, other insubstantial and unsubstantiated
policies might collapse. We might even see a domino theory in
action--with more attention paid to science rather than emotion
when developing policies dealing with air pollution and acid rain,
and with putative stratospheric ozone depletion and global warming.
-----------------------------
Presented at seminar organized by the International Center for
Scientific Ecology, Paris., May 10, 1993.
N
N
O
N
~
a
A
~
A
O
