Modernize the Food Safety Laws: Delete the Delaney Clause

The overriding goal of federal policies governing the use of chemicals in agriculture and food processing is-and should be-consumer safety. One would hope that food safety regulation would be driven by the best scientific and medical knowledge. But instead, much of the American food supply is held hostage to the misguided absolutism of what is known as the Delaney clause, a nearly 40-year-old, 55-word quirk in the law. It reads, in its entirety:

No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or laboratory animals or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals.

The Delaney clause was an inappropriate regulatory standard from the moment of its enactment. Its intolerance for even the most minuscule risks and its singular focus on cancer as determined in animal tests would, if interpreted literally, force off the market many substances utilized in agriculture and food processing that are widely regarded as safe when used as intended.
"The [Delaney] clause does not provide for rational, scientific evaluation of carcinogens," the International Federation of Societies of Toxicological Pathologists (IFSTP) declared in a major policy statement this year. "It ignores the fact that the diverse mechanisms now known to underlie cancer increases in rodents exposed to high doses of chemicals are often inapplicable to man. Current evaluation of chemicals based on the tenets of the clause is irrational in many cases." It is little wonder that no other country has implemented comparable legislation.

In the decades following its enactment, regulators for the most part declined to enforce the Delaney clause to the letter. No more. As a result of a 1993 court decision and subsequent settlements of follow-up litigation, federal regulators have begun to enforce Delaney's zero-tolerance standard to the letter. Make no mistake: Vast technological advances since 1958 allow the detection of disappearingly minute amounts of virtually any substance. Thus, Delaney's zero-tolerance standard really means zero. A number of useful and safe food chemicals already are in the process of being withdrawn from the market.

The end results for consumers will be grim: Fewer choices of fresh produce, frozen foods and canned goods, and higher prices for what will remain on grocers' shelves. Fruit and vegetable growers, as well as grain processors, will suffer major economic dislocations. Although there are no firm estimates of total economic cost, they undoubtedly amount to many billions of dollars.
What's more, reduced selection at the grocery store inevitably will lead to a less healthy diet for most Americans. And for all that, it is exceedingly unlikely that there will be any detectable increase in the safety of the remaining U.S. food supply.

These costly consequences easily can be avoided-if Congress repeals the Delaney clause. Otherwise, strict enforcement of the law will run its costly course.

An overwhelming body of scientific evidence argues in favor of repeal. Without the Delaney clause, regulators would be freed to follow a more reasonable standard that allows for continued evolution in scientific knowledge while at the same time providing a margin of safety. Indeed, this is the approach followed in regulation of food additives wherever the Delaney clause does not currently apply, and this is the approach favored by regulators. As the IFSTP declares, "legislative changes should allow for negligible risk levels of chemicals that with reasonable certainty pose no risk of harm."

The Delaney clause is and for some time has been a scientifically indefensible double standard. It fails even in its stated objective to prevent cancer because it focuses on essentially hypothetical risks instead of real ones that people can change. Quirks in the law keep known hazards on the market that could be replaced by lesser hazards.

The political case for repeal is more problematic, primarily because an array of interest groups and bureaucratic constituencies would lose power. They are likely to cast any attempt to repeal Delaney as an effort to expose Americans to almost certain death from cancer.

A vote for repeal of the Delaney clause emphatically is not, as the Delaney clause's supporters contend, a vote "for cancer." To the contrary, a vote to repeal the Delaney clause and, if politically necessary, explicitly to replace it with a more flexible process, is a vote for good health, a vote for worrying about risks people can do something about, a vote for availability of a wide variety of inexpensive, safe foods.

Who is the extremist: the group that would ban a coloring because there is a one-in-19-billion elevated risk of cancer, less than one in the entire world, or the lawmaker who says that's going a bit too far? Who is the extremist: the organization that would push Americans back to an 18th-century food supply; i.e., one held hostage to local markets and weather conditions, or the lawmaker who says it is better for Americans to have access to a wide variety of foods all year long? Who is the extremist: the group that would deny Americans access to foods that could help prevent cancer, or the lawmaker who wants Americans to have access?

The Delaney clause is an anachronism that is hazardous to Americans' health. Congress should repeal it, not because the Congress is in favor of cancer, but because it is in favor of science and common sense.

Modernize our Food Safety Laws: Delete the Delaney Clause