President Clinton's new chief of EPA [U.S. Environmental Protection Agency] got off to a rocky start last week. During an interview with NEW YORK TIMES reporter Keith Schneider, EPA's Carol Browner said something that Schneider interpreted as follows: "The Administrator of the [U.S.] Environmental Protection Agency said today that she would ask Congress to relax a law that prohibits trace amounts in food of chemicals that cause cancer in animals."[1] The next day Browner's office denied she had said any such thing.[2] But key environmentalists weren't buying her denials.[3] It is clear that this is shaping up as a major fight between the Clinton administration and its friends in the environmental community.

At issue is the "Delaney clause," which Congress inserted into section 409 of the federal Food, Drug and Cosmetic Act in 1958. The Delaney clause (named after its author, Congressman James Delaney, D-N.Y.) flatly prohibits FDA approval of any food additive found to cause cancer in humans or animals. FDA (U.S. Food and Drug Administration) has legal authority to approve or disapprove food additives. EPA has responsibility for approval of pesticides.[4] A federal appeals court in July 1992 ruled that, if EPA finds residues of cancer-causing pesticides in processed food like ketchup or canned soup, this violates the Delaney clause.[5] There are only two possible solutions: weaken the Delaney clause or ban the pesticides.

The Delaney clause has created problems for the food chemicals industry, and for regulatory officials, for 35 years. The trouble began on November 6, 1959 --right before Thanksgiving--when a federal official announced that residues of a pesticide called amitrole (then thought to cause cancer in rats) had been found in cranberries and recommended that the public stop buying cranberries.[6] As a result, amitrole was phased out during the 1960s.

A month after the cranberry scare, federal officials learned that a chemical called DES (diethylstilbestrol) had been shown to cause cancer in laboratory animals. At that time, DES was widely used as an additive in chicken feed, and DES residues were measurable in chickens sold in grocery stores. Officials banned DES from chickens and the DES story faded from the newspapers (only to reappear later). DES was still allowed as a feed additive for beef and sheep because residues had not been measured in those animals. (It turned out later that residues were not found in beef because FDA had stopped sampling beef to avoid getting themselves squeezed between the beef industry and the Delaney clause.)[7]

DES-in-chickens and amitrole-on-cranberries faded from view in 1960, but the cranberry scare of Thanksgiving 1959 left an indelible residue of suspicion and worry in the public mind.

The early 1960s was a time when the pesticide industry was gearing up in a big way. Even after the development of enormously wasteful 4000-pound automobiles with 450-horsepower engines, sale of petroleum products was still disappointing, so oil companies were looking for new ways to use up petroleum. Pesticides (and later plastics) solved this problem. (Still today pesticides are a $5.7 billion-per-year business.)

With politically powerful oil companies pushing pesticides (using the Department of Agriculture's [USDA] network of Experiment Stations and Cooperative Extension Agents as a sales force) regulatory officials found themselves in a bind. The Delaney clause is quite clear: if a chemical causes cancer in animals or humans, none of it--zero--can legally remain in processed food.

Squeezed between the pesticide industry and the Delaney clause, FDA and USDA jointly asked the National Academy of Sciences to examine the "zero tolerance" provisions of the Delaney clause. In 1965 the National Academy concluded that the concept of zero residues and zero tolerance were scientifically and administratively untenable and should be abandoned.[8] They argued that improved measuring techniques allowed the detection of very small quantities of chemical residues, so zero would not usually be found. (Of course zero would be found if the toxic chemicals were banned entirely, but the Academy did not discuss that politically-incorrect alternative.)

FDA and USDA adopted the Academy's recommendations--which accorded well with the wishes of the pesticide industry--and on April 13, 1966 the two agencies began establishing allowable levels (called "tolerances") of cancer-causing pesticides in certain raw foods. They could do this because of the peculiar way the 1958 law had been written, or so they thought. Section 408 allowed use of a cost-vs.-benefit calculation to decide whether cancer-causing residues would be allowed on raw foods, whereas section 409 (the Delaney clause) absolutely prohibited any cancer-causing residues in processed foods. Under section 408, officials can weigh the value of abundant cheap food vs. a few thousand cancer deaths and conclude that a few thousand deaths have negligible value. The Delaney clause does not allow any such horse trading: zero tolerances (and therefore zero deaths) are required by Delaney.

For the next 25 years, officials skirmished with the courts over the exact way the Delaney clause was supposed to be applied.[9] Under relentless pressure from the food chemicals industry to allow more and more poisons into the food supply, regulators in the mid-1980s asked the National Academy of Sciences to revisit the Delaney clause. In 1987 the Academy said again that zero tolerance is unworkable, and they recommended adoption of a uniform standard that would allow one out of every million citizens to be killed by each use of each pesticide.

Unfortunately for the food chemicals industry, in issuing its opinion, the Academy also published its evaluation of the current risk from some pesticides. The Academy looked at 289 pesticides and found 53 of them oncogenic (meaning they have the potential to cause cancer in animals or humans or both). "Unfortunately," the Academy said, "the data supporting many of these pesticides are incomplete." [10] The Academy could find useful data on only 28 of the 53. The Academy then calculated the total cancer risk from maximum allowable exposure to those 28 pesticides and showed that the total risk was 5.8 cancers per 1000 people, or 1.45 million cancers during 70 years. This translates to 20,700 cancers each year from these 28 pesticides. [11]

In October, 1988, EPA announced it was taking the Academy's advice and beginning to allow "negligible amounts" of cancer-causing pesticides in processed foods. [12] The agency defined "negligible" as causing cancer in one in every million people exposed for their lifetime (70 years). This led to a court battle, which EPA lost in July, 1992.

So this is the situation Carol Browner inherited. It is now crystal clear that the Delaney clause requires EPA to ban many common pesticides because they are measurable in processed foods and they can cause cancer in either humans or animals.

The food chemicals industry takes the position that small amounts of cancer-causing chemicals are no problem. They frame their argument in terms of "science." They say the "science" of 1958 was crude. Ms. Browner is clearly sympathetic to this point of view. She calls the Delaney clause a "scientific anachronism" meaning it's scientifically out of date.[1] By this she means that the modern "science" of risk assessment reveals that the cancer risk is small and that modern people should willingly tolerate such small risks. She says, "EPA does not believe that the pesticides [that would be banned by the Delaney clause] pose an unreasonable risk to public health, based on available data."[2]

If Ms. Browner persists in this view, she will probably be in for a tough fight. Any relaxation of the Delaney clause would have to go through powerful committees headed by Ted Kennedy (D-Mass.) and Henry Waxman (D-Calif.). Neither man seems sympathetic to more poisons in the American food supply. The environmental community is also prepared to fight. Laurie Mott, a senior scientist with the Natural Resources Defense Council (NRDC) said February 4, "We think [people] should be outraged at the administration, which said it was going to be very concerned and active about environmental issues--and the first thing we hear publicly from the administrator of the EPA is that the agency might consider weakening the Delaney clause."[3]

Furthermore, the public clearly doesn't want poisons in its food. A 1988 national survey by the Food Marketing Institute found that approximately 75 percent of consumers are "very concerned" about pesticides in their food--a higher percentage than are worried about cholesterol, fats, salt, additives, or any other components of food. [13]

Since pesticide experts are now saying that up to 90% of pesticides are not necessary (RHWN #240), and since the National Academy of Sciences has documented examples of successful farms that use no pesticides at all, [14] the public seems likely to want to stick with the existing law, which says the only acceptable risk is zero.
--Peter Montague, Ph.D.

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[1] Keith Schneider, "E.P.A. Plans to Seek Loosening of a Law on Food Pesticides," NEW YORK TIMES February 2, 1993, pgs. 1, [10.]10.

[2] U.S. EPA, "Statement on Pesticide Regulation," ENVIRONMENTAL NEWS [R-34] (Washington, D.C.: U.S. EPA, Office of Communications, Education and Public Affairs, February 2, [1993),] pg. 1.

[3] "Where Should U.S. Pesticides Laws Go From Here," GREENWIRE Feb. 4, 1993. Greenwire is a "daily executive briefing on the environment" distributed on-line; phone (703) [237-5130.]237-5130.

[4] Richard Wiles and others, REGULATING PESTICIDES IN FOOD; THE DELANEY PARADOX (Washington, DC: National Academy Press, [1987).]1987).

[5] Keith Schneider, "Court Expands Pesticide Ban To Cover Many Used in [sic] Food," NEW YORK TIMES July 9, 1992, pgs. 1, [16.]16.

[6] Edward W. Lawless, TECHNOLOGY AND SOCIAL SHOCK (New Brunswick, N.J.: Rutgers University Press, 1977), pgs. 55-93.

[7] Lawless, pgs. 75, 76.

[8] Lawless, pg. 63.

[9] For example see Marjorie Sun, "Food Dyes Fuel Debate Over Delaney," SCIENCE (August 23, 1985), pgs. 739-741.

[10] Wiles, cited above, pg. 51.

[11] Wiles, cited above, pg. 68. And see Michael Weisskopf, "Pesticides in 15 Common Foods May Cause 20,000 Cancers a Year; Tomatoes, Oranges, Wheat Among Those Posing Worst Risk," WASHINGTON POST May 21, 1987, pg. A-33.

[12] Philip Shabecoff, "E.P.A. is Changing How it Regulates Pesticides in Food," NEW YORK TIMES October 13, 1988, pgs. 1, B12.

[13] U.S. Congress, Office of Technology Assessment, PESTICIDE RESIDUES IN FOOD: TECHNOLOGIES FOR DETECTION [OTA-F-398] (Washington, DC: U.S. Government Printing Office, October, [1988),] pg. 3.

[14] Richard Wiles and others, ALTERNATIVE AGRICULTURE (Washington, D.C.: National Academy Press, 1989).