Delaney Clause

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The Delaney Clause which was also known as the 1958 Delaney Amendment to the Federal Food Drug and Cosmetic Act created an absolute prohibition against the deliberate introduction of any level of carcinogen into the food supply. This created problems for the chemical, pesticide, agricultural and tobacco industries since detectable traces of some cancer-producing substances could often be found in their products.

Risk Science, Analysis & Management
Risk Assessment History/tobacco
Risk Assessment & Management Commission
Task Force on Regulatory Relief (WhiteHouse)
Delaney Clause (Food, Drug Act)
ILSI Risk Science Institute
Society for Risk Analysis
Harvard Center for Risk Analysis (HCRA)
Harvard Group on Risk Management Reform (HGRMR)
Resources for the Future
Coalition for Uniform Risk Estimation (CURE)
Institute for Regulatory Policy (IRP)

The Reagan Administration was 'encouraged' by these corporations to lighten the corporate load of regulation by diluting this clause, but most health workers and biomedical scientists thought it should be retained or strengthened. The FDA and the EPA were both in the middle battle-ground, but the EPA was run at this time by Anne M Gorsuch who was an enthusiast for de-regulation.

[Note Anne McGill Gorsuch remarried at this time and became Anne Gorsuch Burford.)

Documents & Timeline

1958 Supposedly the date at which the original amendment was made to the Federal Food, Drug and Cosmetic Act by the addition of this clause.

1973 Feb 15 Tom Osdene and Ray Fagan of the Philip Morris Research Center produce a working document: The Scientific Basis for the Delaney Amendment. [2]

1987 Sep 9 [Extension of Remarks] for Congressional Record by Democratic Congressman from California, Henry Waxman using notes by a leading cancer researcher, Samuel S Epstein , Professor of Occupational Evironmental Medicine, University of Illinois Medical Center.

Furthermore, legislative language traditionally has been ambiguous, thus allowing maximal regulatory discretion to bureacracies which in some instances, have subsequently become closely associated with or even "captured" by the regulated industries. A noteworthy exception is the 1958 Delaney Amendment to the Federal Food Drug and Cosmetic Act, with its absolute prohibition against the deliberate introduction of any level of carcinogen into the food supply. Even so, the Reagan FDA is re-defining the Delaney Amendment to allow carcinogenic food additives at levels alleged to be devoid of significant risk.


1995 Mar 10 Investors Business Daily attacking anti-cancer crusaders:

Added to the Federal Food, Drug and Cosmetic Act in 1958, the Delaney clause says that additives known to induce cancer cannot be introduced into food -- period.

Named for its sponsor, Rep. James J. Delaney, D-NY, the clause originally sprung from public concern about cancer and the Food and Drug Administration's decision permitting the use of a known carcinogenic pesticide called Aramite in food. Combined with a mandated pesticide re-registration process that is supposed to be complete in 1997, the well-intentioned but the zero-risk mindset lying behind both laws already has begun to inflict heavy costs on US. ag-related industries. Page 36 [4]

This unsourced document is worth repeating in full. It has been written by Peter Gunn Montague (co-founder and director of Environmental Research Foundation) (E.R.F.) in Annapolis, Maryland (See references below)
The Clinton administration is far along toward achieving environmental goals that President Bush and Vice-President Dan Quayle tried to reach but couldn't. Specifically, the Clinton administration has now:
(a) generated a bandwagon effect in Congress to get rid of the Delaney clause, the law that forbids the government from approving food additives that cause cancer in humans or animals;
(b) issued an Executive Order that officially embeds "risk assessment" into the "philosophy of regulation" that guides all government regulatory agencies; and
(c) cut the budget of U.S. Environmental Protection Agency by $217 million for 1994, leaving EPA with a 1994 budget that is $485 million less than the agency's budget was in 1980 (in constant dollars).[1]

Dumping Delaney
In testimony before Congress September 21, the administration urged lawmakers to get rid of the Delaney clause (the law that says the government cannot approve, for processed foods such as soup and ketchup, food additives shown to cause cancer in animals or humans).[2]

In place of Delaney, the administration urged Congress to substitute risk assessment and to adopt the idea that "one in a million deaths" is a "negligible risk." [3] Under the administration's proposal, toxic residues from each chemical on each type of food would be capped so as to kill no more than one citizen out of every million citizens each year. Since there are approximately 250 million Americans, residues from each food-use of each pesticide would be capped so as to kill no more than 250 Americans each year, maximum.

Of course the effects would be additive; residues of pesticide A on CARROTS would be set to kill no more than 250 people each year; residues of Chemical B on CARROTS would be set to kill another 250 people, maximum. Residues of Chemical A on APPLES would be set to kill another 250 people, maximum, and so on. No one knows--or even knows how to calculate--the total number of human deaths and other damage that would be allowed under the administration's proposal. There are somewhere between 21,000 and 24,000 different uses of about 600 individual pest-killing chemicals ("active ingredients") now approved by the government, though most are not approved for use on food crops.[4] In addition there are about 2000 "inert ingredients" mixed into pesticides. Though many of these "inert ingredients" are themselves toxic and even carcinogenic (for example, benzene), they are not considered in risk assessments and they are not listed on product labels, so no one knows who is being exposed to them.[5] The administration's "pesticide reform" testimony is silent on inert ingredients.

It seems mathematically certain that thousands of individual "one-in-a-million" risks do not add up to one "one-in-a-million" risk, but toxicological science has no way of analyzing multiple exposures, cumulative exposures, cumulative damage, or multiplier effects known to occur between different chemicals. Thus the administration's proposal, in effect, gives blanket permission to the food-chemicals industry to continue adding new chemicals into the American food supply each year without anyone ever being able to calculate the consequences. Thus the chemical industry continues to evade accountability for its behavior, with the Clinton administration's willing assistance.

The administration HAS expressed concern for food safety. In its testimony before Congress, the administration promised that if it learns that a particular food-use of a particular chemical is killing 10 times the allowable maximum of 250 citizens each year, such a chemical will only be allowed to remain in use for 10 years.[6] The chemical industry has been trying to get rid of the Delaney law since 1959,[7] but Congress has always been reluctant to substitute "a little bit of cancer-causing chemicals in your processed food" for the Delaney standard of "no approved cancer-causing chemicals in your processed food." The administration seems to have broken that reluctance. Since the administration urged Congress to get rid of Delaney, a bill to do that (H.R. 1627) has gained nearly 200 sponsors in the House of Representatives and a bandwagon effect is apparent as we go to press. As of this moment, Delaney seems doomed.

My personal observation is that some of the so-called "pesticide reform group" of environmentalists in Washington, D.C., have accepted the demise of Delaney as inevitable and perhaps even desirable because the administration wants Delaney killed. The D.C. environmental community has been "on the outs" for a dozen years and is so eager to become "a player" once again that some groups don't seem to care what game they're invited to play. In the presence of two dozen national environmental leaders last May, I heard the head of a major environmental organization announce to EPA chief Carol Browner, "You are our general. We are your troops. We await your orders." The result of such boot licking is now becoming apparent.

Risk Assessment Now Guides All U.S. Regulation
President Clinton quietly signed Executive Order 12866 on September 30, 1993, officially embedding risk assessment in the U.S. "philosophy of regulation." All federal regulatory agencies will now be guided by a "regulatory philosophy" that explicitly includes risk assessment. Vice-President Dan Quayle had tried to accomplish something similar during the Bush administration but had failed.[8] Risk assessment is a mathematical technique intended to determine the probability of certain kinds of damage to humans and the environment from chemical exposures. Unfortunately, because so little is known about the way chemicals exert their toxic effects, and because science has no way of assessing the effects of multiple chemical exposures, risk assessment can be used to reach nearly any conclusion that a risk assessor wants to reach.

As former EPA chief William Ruckelshaus once said, "A risk assessment is like a captured spy. Torture it enough and it will tell you anything." The chemical industry has been working relentlessly since 1975 to expand the use of risk assessment throughout government. Executive Order 12866 is arguably the culmination of their efforts. From the viewpoint of anyone who wants to spread chemicals into the environment, risk assessment is a marvelously useful technique: Because it is based in mathematics, most people can't even understand it, much less participate in it, so it immediately excludes most of the public from decisions.

Furthermore, because it is mathematical, the result gains an aura of certainty and precision, even if it is based on "data" that are nothing more than guesses. Before he became chief of U.S. EPA, William Reilly wrote, "The National Research Council concluded in a 1984 report that fewer than 2 percent of the chemicals currently used for commercial purposes have been tested sufficiently for a complete health hazard assessment to be made.

Adequate information to support even a partial hazard assessment is available for only 14 percent of the chemicals; for 70 percent, no information is available. Moreover, these percentages refer only to human health hazards. In general, environmental hazards are even less well understood."[9] Never mind that there are no data. This has never stopped a dedicated risk assessor from calculating risks to the third decimal place, presenting the results as factual and reliable, then using the results to support a political decision to impose unknown risks on the public.

EPA budget

Cutting EPA's Budget Under the administration's 1994 budget, EPA will have less money than it had in 1993 for controlling pesticides, toxic substances, water quality and drinking water. "The cut in EPA's budget is evidence of the low priority given environmental protection funding by the President," said Marc Smolonsky, a budget analyst in Washington.[1] "There will be scant resources for pollution prevention activities, such as waste minimization. Without funds for prevention now, future clean up costs will skyrocket, leaving the impression that the Clinton administration is penny-wise but pound-foolish on environmental protection programs," he said.

"EPA's pesticide program is unable to ensure the safe use of pesticides and respond efficiently to evidence of high-risk pesticides," Smolonsky said. "At a time when the administration has announced a plan to reform federal pesticide policy, it is overseeing a cut in funding for the EPA pesticide program, which will be reduced by approximately 15 percent." --Peter Montague


[1] Personal communication October 13, 1993, from Marc Smolonsky, Executive Director, Environmental Budget Priorities Project, Environmental Working Group, Washington, D.C.; phone (202) 667-6982.
[2] "Testimony of Carol M. Browner, Administrator, US Environmental Protection Agency, and Richard Rominger, Deputy Secretary, U.S. Department of Agriculture, and David A. Kessler, Commissioner, Food and Drug Administration Before Committee on Labor and Human resources United States Senate and Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, September 21, 1993." 63 pgs.
[3] "Testimony...," cited in note 2, pg. 6.
[4] Shirley A. Briggs, "U.S. Federal Regulation of Pesticides," in Shirley A. Briggs, editor, BASIC GUIDE TO PESTICIDES (Washington, D.C.: Hemisphere Publishing, 1992), pg. 282.
[5] EPA recently issued a new list of approved "inert" ingredients; to get the list, phone Clare Grubbs at EPA: (703) 305-5805.
[6] "Testimony...," cited in note 2, pg. 12.
[7] The early history of Delaney can be found in Edward W. Lawless, TECHNOLOGY AND SOCIAL SHOCK (New Brunswick, N.J.: Rutgers University Press, 1977).
[8] Thorne G. Auchter, TOWARD COMMON MEASURES; RECOMMENDATIONS FOR A PRESIDENTIAL EXECUTIVE ORDER ON ENVIRONMENTAL RISK ASSESSMENT AND RISK MANAGEMENT POLICY. (Washington, D.C.: Federal Focus, Inc., 1991). This report to Vice President Dan Quayle by a conservative think-tank, provided justification for, an Executive Order they hoped President Bush would issue. Mr. Bush demurred and the order was never signed. Auchter was a full-time professional tobacco lobbyist.
[9] William Reilly, editor, STATE OF THE ENVIRONMENT: A VIEW TOWARD THE NINETIES. (Washington, D.C.: The Conservation Foundation, 1977), pg. 425.