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--- June 3, 1993 ---
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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:


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 ==

[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;

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