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#340 - NRDC Defends Delaney, 02-Jun-1993

Natural Resources Defense Council (NRDC), a national environmental
group based in Washington, D.C., has published a resounding defense of
the Delaney clause, and a devastating attack on risk assessment, thus
staking out a strong position in the fight to save Delaney and to keep
ALL cancer-causing food additives out of the American food supply.
However, it remains to be seen whether an NRDC-led pesticide reform
coalition can maintain its strong position in the face of forces
seeking a political compromise.

In any case, NRDC's new defense of Delaney provides a scientifically
valid standard against which any pesticide reform proposals can be

The Delaney clause is a portion of federal law that prevents FDA (U.S.
Food and Drug Administration) and EPA (U.S. Environmental Protection
Agency) from approving food additives, including pesticide residues,
that have been shown to induce cancer in animals or humans. (See RHWN
#324, #326 and #339.) The food chemicals industry has pulled out all
the stops in Washington, lobbying to persuade Congress to kill the
Delaney clause and start allowing cancer-causing chemicals in our food.
The exact levels of cancer-causing chemicals allowed in food would be
determined by government bureaucrats using a mathematical technique
called "risk assessment."

The defense of Delaney, by NRDC attorney Al Meyerhoff, appears in the
January/February/March, 1993, isssue of EPA JOURNAL, which is published
quarterly by U.S. Environmmental Protection Agency.

In the same issue of EPA JOURNAL, a top EPA official makes it crystal
clear that EPA wants to kill Delaney. EPA chief Carol Browner had let
the cat out of the bag in early February when she was quoted in the NEW
YORK TIMES in early February saying she intended to ask Congress to
kill Delaney. (See RHWN #324.) The public responded with outrage, and
Browner backed off the next day, saying she had been misquoted. But the
new article in the EPA JOURNAL, by Victor Kimm, EPA's Acting Assistant
Administrator for pesticides, leaves no doubt that EPA seeks to kill
Delaney, and to substitute "risk assessment" in its place.

The Delaney standard for cancer-causing chemicals in food is zero. EPA
and the food chemicals industry want to get rid of the zero standard.
What EPA and the food chemicals industry want instead is a "one-in-a-
million" risk standard. Such a standard would allow EPA and FDA risk
assessors to manipulate mathematics to calculate an amount of a cancer-
causing pesticide that would offer "negligible" risk to the public.
Sometimes "negligible risk" is also called DE MINIMIS risk, using a
legal term that means "so small it doesn't matter." EPA defines a
"negligible risk" as the risk of killing one in every million citizens
each year by giving them cancer. The negligible risk standard is
calculated for each food use of each pesticide. In other words
pesticide A on asparagus is allowed to kill one in every million
citizens each year; pesticide A on peaches is allowed to kill another
one in a million each year; pesticide B on asparagus can kill an
additional one in a million each year, and so on.

Nowhere in the risk assessment process does the government ever tally
up all the deaths that have been allowed by issuing permits for the
many different chemicals put onto many different foods.

[Incinerators, landfills, and thousands of toxic releases from
factories are also permitted on the basis of risk asssessments
performed by government bureaucrats armed with pocket calculators. Each
individual risk assessment is completed without regard for any other
risk assessment, so thousands of Americans are "permitted" to die each
year because of the cumulative impact of all the government's risk
assessments. But each risk assessment concludes that the risk is
"negligible." Thus risk assessment is a technique used to justify
killing and maiming citizens without due process, and destroying
ecosystems, without anyone ever having to acknowledge that any damage
has been done.]

The NRDC defense of Delaney makes many important points, which we will
summarize here:

(1) What we don't know is much larger than what we know about the
effects of pesticides on people and ecosystems. [It is a fact that EPA
still lacks basic toxicity, health and ecosystem data on most of the
pesticides that are currently used.][1]

(2) Delaney represents a policy of prevention, based on prudent
protections for the environment and human health.

(3) A policy not based on prevention would expose the entire American
population to a vast array of carcinogenic and toxic chemicals in their
food. [As a practical matter, it would then be up to the American
people to "prove harm" before any of those chemicals could be removed
from our food. Such an approach would guarantee that harm must occur
before prudence prevailed.]

(4) Has science improved to a point where we can pinpoint the exact
amount of a chemical that will cause harm in the environment or in
humans? Can industry affirmatively demonstrate that each food-use of
each pesticide is safe? If the answers are No (and they are), then the
Delaney approach is necessary.

(5) There are inherent uncertainties in risk assessments, because
scientific knowledge is gained from experiments on laboratory animals,
which may not react the same as people.

(6) EPA and FDA are discrediting science and undermining the integrity
of science by claiming that risk assessments are better than they are,
and by claiming that science can discern which risks are so small as to
not matter. [Whether a risk matters or not is not a scientific
question; it is a value question, about which scientists have no
special expertise.]

(7) Risk assessments ignore special populations--children, for example,
or people who eat lots of strawberries, lots of fish, or lots of

(8) Risk assessment is fundamentally defective because it only
considers one chemical at a time, and in real life we are exposed to
many chemicals simultaneously. Scientific knowledge cannot help here
because problems of multiple exposure are too complex for science to
ever sort out.

(9) Risk assessments only consider the effect of "active" ingredients
in pesticides, but all pesticides contain so-called "inert"
ingredients, many of which are potent toxins themselves. "Inerts" are
never considered in risk assessments.

(10) The main policy underpinning the Delaney clause is that we should
avoid unnecessary and involuntary exposure to cancer-causing chemicals.
This policy is as valid today as it was in 1958 when Congress enacted

Here is NRDC's defense of Delaney:


by Al Meyerhoff

The essential premise of the Delaney clause of the Food, Drug and
Cosmetic Act is as simple as it is powerful: What we understand best
about carcinogens is the limited extent of our knowledge. Accordingly,
the famous clause is grounded in a policy of prevention: prohibiting
the addition of carcinogens in the food supply to prevent avoidable
cancers in humans. This approach was deemed necessary by Congress since
the entire nation's population would otherwise be routinely exposed to
carcinogens in their daily diet.

More than three decades after the Delaney clause was enacted in 1958,
the public policy issue now presented is whether science has evolved to
the point where this premise is no longer valid. Are the principles and
practice of cancer risk assessment up to the task of providing complete
protection from cancer to consumers exposed to carcinogens in their
food? Or, to put the question differently, Can those industries
responsible for that exposure affirmatively demonstrate that it does
not jeopardize public health?

Perhaps unfortunately, but demonstrably, the answer remains no.
Inevitably, to quote from a FEDERAL REGISTER notice published by EPA in
1991 (56 FR 7750, 2757), "There are inherent uncertainties in
quantitative risk assessment because, among other things, of the
necessity of relying on data from animal studies to predict human

As a result, the same starting data in risk assessments can yield
predictions that vary over several orders of magnitude, depending on
the assumptions that go into the model. As FDA Deputy Director Robert
Scheuplein warned in 1987, in a paper called "Risk Assessment and Food
Safety: A Scientist's and Regulator's View," agencies like EPA "risk
losing the integrity of the science and objectivity they need from it
by continuing to suggest risk assessments are better than they are and
that cancer risk can be so clearly self-evidently dismissed as DE
MINIMIS [so small they don't matter] solely on a scientific basis. We
have not seen a scientific breakthrough which now permits the precise
assessment of low-level cancer risks."

Existing risk assessments also virtually ignore the special risks toxic
chemicals may pose to infants, young children, or various
subpopulations, yet they may be at greatest risk from dietary exposure
to carcinogens. Moreover, taking a chemical-by-chemical, use-by-use
approach as the long-term policy objective, rather than an interim step
to overall pesticide use reduction, ignores the fundamental deficiency
of risk assessment--that it looks at only one chemical at a time.

The reality of life is that we are exposed to a multiplicity of toxic
substances. Calculating the combined risks of these exposures is
problematic; some 300 pesticidal active ingredients are used on food as
well as an imperfectly examined large number of "inert" ingredients.
For the most part, existing EPA pesticide tolerances for allowable
pesticide residue levels do not even attempt to calculate the aggregate
human health risks presented, nor do they address the cumulative and
synergistic effects on [of?] multiple pathways of exposure. For this
reason, ultimately, the overall policy underlying the Delaney clause--
that we should avoid unnecessary and involuntary exposures to cancer-
causing agents--remains as valid today as when enacted.

--Peter Montague, Ph.D


[1] William A. Stiles, Jr., "Food Safety and the Federal Insecticide,
Fundgicide, and Rodenticide Act," in B.G. Tweedy (editor), PESTICIDE
RESIDUES AND FOOD SAFETY (Washington, D.C.: American Chemical Society,
1991), pgs. 324-332.

Descriptor terms; nrdc; natural resources defense council; delaney
clause; pesticides; fda; food and drug administration; epa; us
environmental protection agency; cancer; risk assessment; al meyerhoff;
victor kimm;