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#324 - Ms. Browner Meets Mr. Delaney, 09-Feb-1993

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

=====

[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).

Descriptor terms: carol browner; delaney clause; pesticides; cancer;
pesticide residues; food safety; des; amitrole; fda; usda; pesticide
industry; chemical industry; national academy of sciences; risk
assessment; epa;