=======================Electronic Edition========================
RACHEL’S HAZARDOUS WASTE NEWS #340
— June 3, 1993 —
News and resources for environmental justice.
——
Environmental Research Foundation
P.O. Box 5036, Annapolis, MD 21403
Fax (410) 263-8944; Internet: erf@igc.apc.org
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NRDC DEFENDS DELANEY
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 judged.
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 anything.
(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 Delaney.
Here is NRDC’s defense of Delaney:
THE DELANEY CLAUSE DILEMMA
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 risk.”
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
==
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;