Posted: 18 July 2006
Originally published in the Environmental Law Report
Posted here with permission
28 ELR 10003 | Environmental Law Reporter |
Delaney Lives! Reports of Delaney's Death Are Greatly Exaggerated
James S. Turner, Esquire
Editors' Summary: When Congress passed the Food Quality Protection Act of 1996 (FQPA), many in the press announced that this law effectively repealed the Delaney Clause, which they claimed had banned all traces of cancer-causing pesticides in processed foods. This Article analyzes what the FQPA actually did. It begins by describing the history of the Delaney Clause. The clause appears in three statutes, most famously in the food-additive provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). The food-additive Delaney Clause, the Article explains, allowed EPA, in effect, to set tolerances for cancer-causing pesticides in both raw and processed agricultural commodities: What it prohibited was pesticides in processed foods in excess of the amount allowed in raw agricultural products. The FQPA did not amend this Delaney Clause, but rather addressed the so-called Delaney Paradox which, according to Delaney critics, resulted because FFDCA § 409 seemed to prohibit residues of cancer-causing pesticides in processed foods, while FFDCA § 408 and FIFRA § 2 permitted the setting of residue tolerances for carcinogenic pesticides in raw agricultural products. What the FQPA did, the Article concludes, was repeal the prohibition on cancer-causing pesticides in processed foods that exceed these raw agricultural commodity tolerances; add a new, more restrictive, safety standard that allows no more than a one-in-one-million risk of cancer from pesticide residues in both raw and processed foods; and then move a tolerance "pass through" provision from § 402 to § 408 of the FFDCA.
Jim Turner is a member of the D.C. and Ohio bars, and is a partner in the law firm of Swankin & Turner in Washington, D.C. He is also the author of The Chemical Feast: The Nader Report on the Food and Drug Administration (Penguin 1977). Linda Bonvie, Jaylene M. Sarracino, Esq., Young Yi, Bill Bonvie, Jamila Smith-Cha-Jua, and Savita Krishnamurthy assisted with the research for this Article.
[28 ELR 10003]
Contrary to the Washington Post ("The bill would effectively abolish the Delaney Clause"),1 the Chicago Tribune ("repeal of the 38-year-old Delaney Clause"),2 the Los Angeles Times ("wipes out the 1958 Delaney Clause"),3 the Natural Foods Merchandiser ("Congress Dumps Delaney"),4 and the House Commerce Committee ("The Delaney [28 ELR 10004] Clause ... will be replaced ..."),5 the 104th Congress did not repeal the Delaney "anti-cancer" Clause.
The Delaney Clause, which provides that "no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, 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 animal," appears in the Food Additives Amendment of 1958,6 the Color Additive Amendments of 1960,7 and the Animal Drug Amendments of 19688 to the Federal Food, Drug and Cosmetic Act of 1938 (FFDCA).9 The 104th Congress changed none of these.
What then did Congress do that led to all the publicity? It passed (by 417-0 in the House and by unanimous consent in the Senate) the Food Quality Protection Act of 1996 (FQPA)10 (H.R. 1627), ending something called the "Delaney Paradox,"11 an allegedly anomalous aspect of pesticide residue law that relates to a comparatively minor (though important) sideline to the major legal aspects of the Delaney Clause. This Article examines that "paradox." It reviews the state of federal pesticide law that existed before passage of the FQPA and notes that the Delaney Clause always permitted residues of cancer-causing pesticides in processed foods as long as they did not exceed the tolerance permitted in raw agricultural commodities. It then traces the regulatory and judicial actions and political debates that led to the FQPA, and concludes that the FQPA neither removes the protections provided by the Delaney Clause prohibition against adding cancer-causing substances to food nor reflects a public policy rationale or political consensus to do so.
The Delaney Paradox
The FQPA, the legislation passed by the 104th Congress, repealed the part of the food-additives law that prohibited a cancer-causing pesticide residue in processed food if it exceeded the tolerance established by the U.S. Environmental Protection Agency (EPA) for that pesticide in raw agricultural commodities. The so-called paradox allegedly arose, according to an October 19, 1988, EPA Federal Register announcement,12 because while the food-additive Delaney Clause in § 409 of the FFDCA13 appeared to prohibit all residues of cancer-causing pesticides in processed foods, § 408 of the FFDCA14 and § 2 of the Federal Insecticide, [28 ELR 10005] Fungicide, and Rodenticide Act (FIFRA)15 permitted the setting of residue tolerances for carcinogenic pesticides on raw agricultural commodities if the benefits of a pesticide's use outweighed its risks.
However, as Ninth Circuit Judge Mary M. Schroeder made clear in her opinion in Les v. Reilly, the case that led directly to the legislation passed by the 104th Congress:
When a tolerance or an exemption has been established for use of a pesticide on a raw agricultural commodity, then the FFDCA allows for the "flow-through" of such pesticide residue to processed foods, even when the pesticide may be a carcinogen. This flow-through is allowed, however, only to the extent that the concentration of the pesticide in the processed food does not exceed the concentration allowed in the raw food.16
Judge Schroeder said that this "flow-through" provision (§ 402 of the FFDCA)17 "expressly harmonizes the [pesticide-regulation] scheme with the Delaney Clause by providing that residues on processed foods may not exceed the tolerance level established for the raw food."18 The pesticide-regulation scheme of the FFDCA contained a rational regulatory approach (which some embrace and some disavow) allowing the same tolerances for carcinogenic pesticide residues in both raw agricultural commodities and processed foods.
Pesticide Residue: Harmonizing Processed and Raw Food Tolerances for Cancer-Causing Pesticides
The food-additive definition, FFDCA § 201(s),19 harmonized the FFDCA pesticide scheme by defining a food additive as any chemical intentionally added to food except for a pesticide added to raw agricultural-commodities under a FIFRA tolerance, a color additive, a new animal drug, or a prior-sanctioned additive.20 The definition did not exclude pesticide residues in processed food that exceeded a FIFRA tolerance to which, therefore, the Delaney Clause applied. Thus, before passage of the FQPA in 1996, Congress explicitly established, by definition, a harmonized pesticide-residue regulatory system that allowed residues of cancer-causing pesticides at the same level in both raw agricultural commodities and processed foods.
In 1958, Congress adopted the food-additive amendment that harmonized the pesticide-residue system and created a more stringent requirement for cancer-causing chemicals intentionally added to food, including pesticide residues higher than the raw agricultural-commodity tolerances established by the Food and Drug Administration (FDA) (later EPA). Subsequent to the 1958 food-additive amendment, Congress added an anti-cancer provision to color-additive regulation and, when altering animal-drug regulation, retained, with some modification, the cancer prohibition on animal-feed additives.21 Each of these actions entailed serious congressional and public debate, including several extensive committee hearing records. These debates raised serious questions, many of which Congress seemed to overlook in adopting H.R. 1627, leading to significant public confusion.
Three misunderstandings caused the press, following the lead of the House Commerce Committee's new leadership,22 to incorrectly hail the FQPA as repealing the Delaney Clause. First, the press missed the fact that the Delaney Clause covered animal feed, color, and food additives (not addressed by the bill) but not pesticide residues with an EPA tolerance. Second, the press asserted that the Delaney [28 ELR 10006] Clause banned all traces of cancer-causing pesticides in processed foods, when in fact it permitted EPA to establish tolerances of cancer-causing pesticides in both raw agricultural commodities and processed foods. Third, the press reported a nonexistent legal inconsistency (the Delaney Paradox), missing Congress' careful, express harmonization of food-additive and pesticide law that made raw and processed food tolerances identical.
These misunderstandings led to an acrimonious debate between various consumer, environmental, and public interest groups. The National Campaign for Pesticide Policy Reform, joined by 10 Washington, D.C.-based citizen groups, supported the bill, but said, "Although we are pleased with the extent to which the bill was changed to better public health, we have reservations with the sections that will allow benefits consideration for cancer-causing pesticides ...."23 Food and Water of Walden, Vermont, reflected the views of other national citizen groups that opposed the final bill, saying, "Until now, Delaney has been a concrete tool for citizens to use to hold the zero-risk standard over the heads of Congress and industry representatives alike and demand that a zero-cancer risk standard be adopted for all foods. 'No Cancer' is always a better rallying cry than 'A Little Bit of Cancer.'"24 It appears that both sets of groups may have accepted the erroneous assertions that the Delaney Clause set a zero tolerance for carcinogenic pesticide residue in processed food and that H.R. 1627 abolished Delaney. Actually Delaney, which allowed cancer-causing pesticide residues in processed foods that did not exceed pesticide tolerances for raw agricultural commodities, remains in force but is now limited by a redefinition of food additives to exclude all pesticide residues.
The 104th Congress' House Commerce Committee, drafters of H.R. 1627, introduced a separate bill to abolish the Delaney Clause in all cases, the Food Amendments and the Animal Drug Availability Act of 1996 (H.R. 3200).25 This bill, if adopted, would have expressly eliminated the food, color, and animal-feed additive Delaney "zero-tolerance" Clauses by changing them to "a negligible or insignificant risk" (color and feed additives) standard.26 However, the bill did not come to a vote in committee. Its sponsors said that they expected to introduce it in the 105th Congress, but had not done so as of the close of the first session of the 105th Congress in November 1997.
The existence of H.R. 3200 reinforces the impression, created by the misleading Delaney Paradox strategy, that H.R. 1627 was part of a general assault on Delaney that failed in the 104th Congress.27 H.R. 1627 did not address the Delaney Clause directly. Instead, it redefined "food additive" by excluding all pesticide residues. Previously, the definition of "food additive" had included only pesticide residues that were above the raw agricultural-commodity tolerances.28
The impression that H.R. 1627 sponsors intentionally orchestrated a misleading attack on the Delaney Clause is reinforced by the fact that H.R. 1627 moved the flow-through provision, made redundant by the new food-additive definition, to FFDCA § 408, making it officially clear that Congress knew that the Delaney Clause had permitted residues of cancer-causing pesticides in processed foods.29 In addition to redefining food additives and moving the flow-through provision, H.R. 1627 also added a series of restrictions on what constitutes "safety" of a pesticide residue (for both raw agricultural commodities and processed food), focusing particular attention on the safety of pesticide residue for infants and children.30
These specified restrictions on the definition of safety (for example the "reasonable certainty of no harm" defi [28 ELR 10007] identified as one-in-one-million cancers over a lifetime in report language, an additional 10-fold safety margin for infants and children, etc.), set out in more detail below, highlight the fact that there are two discrete parts to the Delaney debate. The most famous aspect of the debate is the zero tolerance for cancer-causing chemicals. The second part of the debate who sets the tolerance, legislators or regulators also has major policy significance. When Congress narrows a legislated safety standard, as it did in the H.R. 1627 definition of safety, it is applying the principles that underlie the second aspect of the Delaney Clause that is, to the extent that Congress says certain risk is unacceptable and then assigns regulators the task of ensuring that such risk is not assumed it limits regulatory discretion.
The legislative formula that was agreed on by pro- and anti-Delaney forces defined additives to exclude pesticide residues and tightened regulatory standards, thereby replacing the explicit tolerances for residues of cancer-causing pesticides in processed foods with a stricter safety standard. This allowed advocates of a cleaner environment to join with food and chemical industry advocates in supporting the elimination of the Delaney prohibition on residues of cancer-causing pesticides in processed foods that exceeded EPA tolerance for such residues in raw agricultural commodities. This coalition formed the basis for Congress' legislative compromise.
However, presenting the pesticide-residue issue as a "pro-Delaney" versus "anti-Delaney" debate in the context of the alleged Delaney Paradox obscured several key issues that deserve serious public and legislative scrutiny. In its attack on the compromise, Food and Water of Walden, Vermont, said, "With Delaney slashed, 35 pesticides that were about to be outlawed because they cause carcinogenic residues in processed foods will now remain in use on major food crops."31 Whether this assertion turns out to be true or not will be a major test of the new law. Environmental, consumer, and public interest group supporters of H.R. 1627 assert that the new stricter standards will not allow any dangerous residues that would have been banned under the previous residue-regulation scheme; industry supporters of H.R. 1627 apparently believe otherwise. One set of questions unanswered by the compromise concerns how it will affect pesticide regulation. Will it make it more stringent? Less stringent? Have no effect at all? (The next section of this Article reviews the fate of the "35" before and after the passage of the FQPA.)
A second set of unanswered questions concerns the degree of discretion allowed regulators. The Delaney Clause sets forth the proposition that government discretion should be limited by prohibiting government regulators from permitting the intentional addition of cancer-causing chemicals to food (except for all pesticide residues now and for those with an EPA tolerance before H.R. 1627 passed). H.R. 1627 allows regulators to permit residues up to an amount that causes no more than one-cancer-per-one-million-human lifetimes.32 Can regulators accurately measure a one-per-million risk? Should they? Are they permitted to? And are they able to measure the interaction between more than one allowed residue in the same food or diet or between an allowed residue and other chemical components in the food supply? (The new law mandates this.) How many aggregated cancer incidences per pesticide (250, 500, more?) does the law permit regulators to allow?33 Congress has assigned pesticide regulators the responsibility for answering these questions. The technical capability to find such answers is a source of controversy.
A third set of questions concerns how much, if at all, the pesticide residue debate, as resolved by the passage of H.R. 1627, applies to Congress' possible review of Delaney's application to color, food, and feed additives. From the time it passed FIFRA34 in 1947, Congress allowed residues of cancer-causing pesticides in food. In 1958, it adopted a compromise with food-safety advocates restricting these residues to an amount equal to the tolerances in raw agricultural commodities. Consumer food-safety advocates recognized that this compromise created a loophole in the Delaney Clause.35 Some environmental, consumer, and public interest advocates argue that H.R. 1627 eliminated the 1958 Delaney loophole by replacing the loose risk/benefit system in the 1954 pesticide law with more stringent restrictions. Others feel that removing the Delaney threat will bring more cancer-causing pesticides into the market. The food, color, and feed-additive applications of Delaney do not contain the pesticide loophole. This changes the nature of the debate about their importance and eliminates the possibility of the kind of trade off that shaped the FQPA pesticide debate. The history, science, and law of American pesticide, feed, food, and color-additive regulation clarifies Delaney's significance and the key role it plays in food-safety regulation.36
[28 ELR 10008]
At noon on January 3, 1995, legendary Mississippi congressman, Rep. Jamie Whitten (D-Miss.) completed the last day of his 54th year in Congress. Known as the autocratic Chairman of the House Agricultural Appropriations Subcommittee for nearly two decades, he was less well known as the committed protector of the Delaney "anti-cancer" Clause, a monument to his late friend and colleague, New York City congressman and fellow House Rules Committee member, Rep. James Delaney (D-N.Y.).
As soon as Representative Whitten left Congress, the forces that had fought adoption of the Delaney Clause in the 1950s and 1960s, and had complained about it continuously since then, organized an assault on Delaney. This campaign escalated with the anti-Delaney rhetoric of H.R. 1627, laying the groundwork for an effort to completely gut the clause via passage of H.R. 3200. Two questions characterize and continue to shape the Delaney debate: when is it safe to add a chemical to food, and who makes that decision.
Passage of the Delaney Clause
In 1952, after two years of work, the House Select Committee to Investigate the Use of Chemicals in Foods and Cosmetics, chaired by Representative Delaney, issued its final report. It recommended that Congress legislate controls on the addition of chemicals to food, including addressing concerns about "any alien material which may find its way, in any amount, into our food supply."37
Committee member Rep. Thomas G. Abernathy (D-Miss.) submitted a minority report recommending separate treatment for pesticides and food additivies.38 In the next Congress, Rep. A.L. Miller (R-Neb.) introduced H.R. 4277,39 which became the Pesticide Rodenticide Amendments of 1954. The final bill, supported by agricultural interests, the pesticides industry, and the FDA (also the primary 1996 constitutency for H.R. 1627), contained a risk/benefit balancing standard which, according to Representative Miller assured "a proper balance between the need for protecting the consumer from unsafe pesticide chemicals in or on food, and the need for assuring an adequate, wholesome, and economical food supply"40 (also the primary 1996 arguments supporting H.R. 1627). In its final report on H.R. 4277, the committee said that the measure "does not attempt to regulate the residue from pesticide chemicals which may remain in or on processed, fabricated, or manufactured food ...."41 H.R. 4277 established § 408 of the FFDCA, permitting pesticide-residue tolerances based on a balancing of risks and benefits. It passed the House without debate and the Senate with little controversy.
At about this time a new force in the controversy appeared. Gloria Swanson, the Hollywood star who most successfully made the switch from silent to talking films (starring in Sunset Boulevard in 1950) adopted "pure food" as her personal crusade. She wrote in her 1980 autobiography:
I became a fanatic about healthy food in 1944 ... and as soon as I learned in 1951 that one U.S. congressman, Representative James J. Delaney from New York, was devoting himself to having laws passed to stop the food we eat from being sprayed and manufactured with harmful chemicals, I threw myself into supporting him in every way I could. In 1952 I was the guest speaker at the Congressional Wives Club ... and instead of telling the six or seven hundred women at the luncheon "all about Hollywood," ... I begged them to go right home and force their husbands, by whatever means they could bring to bear, to vote for the Delaney Amendment.42
Between 1954 and 1958, Congress and the FDA continued to focus on chemicals in food. Many members of Congress introduced food-additive bills,43 Congress held a number of hearings44 and the FDA established, by regulation, a "flow-through" provision applying § 408 raw agricultural pesticide-residue tolerances to processed foods.45 [28 ELR 10009] Thus in 1958, when Congress considered the Food Additive Amendments, the FDA had already established the legality of residue tolerances for cancer-causing pesticides in processed foods.
As the 1958 debate unfolded, Representative Delaney introduced a bill that included the Delaney Clause banning all cancer-causing chemicals in foods whether as pesticide residue or intentional additives. The FDA proposed a bill that did not contain a ban on cancer-causing additives and included the flow-through provision for pesticides.46 It argued that its proposed bill, without the Delaney Clause, prohibited "the use of an additive unless it is established that [the additive] is without hazard to health,"47 making the Delaney Clause redundant and therefore unnecessary. The committee reported the bill without the Delaney Clause.48
In the two weeks between publication of the House report and the floor debate on the bill, the Eisenhower Administration reversed its position and supported the Delaney Clause (with the minor change that animal tests showing a cancer cause needed to be "appropriate"). Health, Education, and Welfare (HEW) Assistant Secretary Elliot Richardson wrote Congress saying:
To single out one class of diseases for special mention would be anomalous and could be misinterpreted. Hence, in drafting [HEW's] bill (H.R. 6747), we chose general language that would restrain any use of an additive that would have any adverse effect on public health .... At the same time, if it would serve to allay any lingering apprehension on the part of those who desire any explicit statutory mandate on this point, [HEW] would interpose no objection to appropriate mention of cancer in food additives legislation.49
The final bill approved by Congress contained the Delaney Clause and the flow-through provision for pesticide tolerances under § 408. When HEW switched its position on the Delaney Clause, it did not point out the "loophole"50 for pesticide residues. Thus, the law banned cancer-causing food additives from food but allowed residues of cancer-causing pesticides in processed food. This anomaly has continued and was reinforced by the 1996 pesticide bill.
The Aftermath of Delaney
In 1960, Congress extended the Delaney Clause to color additives. In supporting this extension, then-Secretary of HEW Arthur S. Flemming said:
The rallying point against the anticancer provision is the catch phrase that it takes away the scientist's right to exercise judgment. The issue thus made is a false one, because the clause allows the exercise of all the judgment that can safely be exercised on the basis of our present knowledge ....
As I pointed out in my original testimony, the opposition to inclusion of an anti-cancer clause arises out of a misunderstanding of how the provision works. It allows the Department and its scientific people full discretion and judgment in deciding whether a substance has been shown to produce cancer when added to the diet of test animals. But once this decision is made, the limits of judgment have been reached and there is no reliable basis on which discretion could be exercised in determining a safe threshold dose for the established carcinogen.51
In 1968, Congress passed the New Animal Drug Amendments,52 which contained the requirement that a cancer-causing animal drug could be used only if, on examination by methods acceptable to it, the FDA found no residue of the drug in the edible tissue of the animal. In 1969, the FDA, without invoking the Delaney Clause, removed cyclamates from the list of food additives generally recognized as safe and from the market after it caused, in combination with saccharin, cancer in experimental laboratory mice.53
Though not a result of the Delaney Clause, the cyclamate ban triggered significant anti-Delaney reactions. The Commissioner of the FDA decried the lack of discretion it allowed him. Food industry spokesmen sought relief from the Delaney barrier to new additives, saying the clause discouraged new research. In 1977, the FDA proposed banning saccharin because it caused cancer in animals. Congress blocked the saccharin ban but required a warning on saccharin products that the Surgeon General had determined that it caused cancer in laboratory animals. Representative Whitten's committee, working with the FDA, commissioned several papers on Delaney, but no legislative activities followed. Between 1977 and 1996, with Representative Whitten discouraging Delaney reform, Congress stayed out of the Delaney debate.
In 1979, Delaney again created controversy when it appeared from scientific testing that nitrite, a widely used preservative in meat, might cause cancer in animals. The FDA, along with the U.S. Department of Agriculture [28 ELR 10010] (USDA), asserted that the benefits of nitrite far outweighed the risks and sought an opinion from Attorney General Griffin Bell and the U.S. Department of Justice's Office of Legal Counsel (OLC) that the FDA could refrain from an outright ban of nitrite if it turned out to cause cancer in animals and could, instead, phase it out over time. The Attorney General and the OLC blocked this desired course of action with strongly worded opinions. The Attorney General said, "The responsibility and the authority to decide whether nitrites are in fact carcinogenic rests exclusively with your two departments." However, once decided, "the statutes contemplate that Congress will make the ultimate determination whether its continued use will be permitted."54 The OLC's position was that "Congress chose to treat potentially carcinogenic substances with extreme caution by enacting the Delaney Clause, which prohibits the Secretary from establishing tolerances for any substance found to induce cancer when ingested by man. Such a substance is therefore unsafe in whatever amount it may be added."55
In 1987, the FDA attempted to circumvent the color-additive Delaney Clause by approving two colors, Orange No. 17 and Red No. 19, which caused very low rates of cancer, 1 in 19 billion and 1 in 9 million, respectively. The agency argued that it had the authority to conclude that a "de minimis" risk of cancer was the same as no risk.56 A unanimous panel of the D.C. Circuit rejected this position and reaffirmed the prohibitions contained in the Delaney Clause.57
In the meantime a boisterous pesticide-residue "Delaney" debate had begun within EPA. Specifically, in February 1985, EPA asked the Board of Agriculture of the National Research Council, the operating arm of the National Academy of Sciences (NAS), to "examine the current and likely future impacts of the Delaney Clause on the tolerance-setting process for pesticides residues in food."58 The board reported in May 1987 with its allegation of the existence of a Delaney Paradox in pesticide regulation. Understanding the paradox concept within the legal context of the food-safety regulatory system underscores the tangential nature of the paradox and the confusion it caused in pesticide regulation.59
The Legal Context of the Regulatory Debate: Food Safety, Delaney, and Pesticide Residue
The Food, Drug, and Cosmetic Act of 1938 and Its Amendments
The Delaney "anti-cancer" Clause requires regulators, using the full range of scientific discretion, to determine whether a chemical added to food causes cancer in animals. If it does, the clause requires the regulators to prohibit its use in food. This clause is a unique congressional response to the problems inherent in the effort to prove the "safety" of a substance intentionally added to food.
Before 1938, federal law, passed in 1906, excluded a food from interstate commerce as adulterated if it contained any added poisonous or deleterious ingredient that might render it injurious to health.60 To act against a dangerous food chemical, the government had to affirmatively prove both that the food contained such an added substance and that it was injurious to health.61 In the 1930s, regulators sought changes in the law to help them make better judgments.
In 1938, Congress passed the FFDCA, redefining "adulteration"62 and, for the first time, allowed the Secretary of Agriculture (currently the Secretary of Health and Human Services) to set tolerances for poisonous or deleterious substances added to food.63 In spite of the changes, however, the new law continued to hamper regulators. The FDA still had to prove affirmatively that a particular chemical was [28 ELR 10011] poisonous or deleterious.64 In addition, the Act's definition of "unsafe" as "poisonous" or "deleterious"65 created a legal non sequitur between §§ 402 and 406. Substitute the word "unsafe" for the terms "poisonous" or "deleterious" in the Act, and the law becomes circular. Section 402(a)(2) would read: "A food shall be deemed to be adulterated ... if it bears or contains any added unsafe substance which is unsafe within the meaning of section 406." Section 406 would read: "Any unsafe substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for the purposes of the application of clause (2) of section 402(a)."
By 1950, the FDA again sought changes in the food law. Between 1950 and 1953, Representative Delaney held hearings on chemicals used in food,66 which led to three major laws amending the 1938 Act: the Pesticide Amendments of 1954;67 the Food Additives Amendment of 1958, which introduced the Delaney Clause;68 and the Color Additive Amendments of 1960, which also included the Delaney Clause.69 All three amendments put the burden of proof of safety on the proponents of a particular chemical, but changed the originally straightforward prohibition on unnecessary or avoidable poisonous or deleterious substances from food to a complicated set of exceptions for pesticides, food additives, and colors.70
The pesticide, food-additive, and color laws all contain essentially the same regulatory structure, consisting primarily of a chemical-by-chemical analysis by "the Secretary." This authority has been delegated to the Commissioner of Food and Drugs for food and color additives and to the Administrator of EPA for pesticide chemicals.71 The Delaney "anti-cancer" Clauses prohibited cancer-causing food and color additives but permitted tolerances for cancer-causing pesticide residue in both raw agricultural commodities and in processed foods as long as the processed-food tolerance did not exceed the raw agricultural-commodity tolerance. The color and pesticide laws contain a provisional listing requisite, and the food-additive law contained a generally recognized-as-safe (GRAS) provision, each designed to deal with chemicals in use at the time the laws passed.
The amendments rested on the assumption that food chemicals could be definitively separated into "safe" and "unsafe" categories, leaving unresolved the definition-of-safety problems inherent in the 1906 and 1938 laws.72 The food-additive amendment illustrates the point. It rests on a prohibition that states: "No ... regulation shall issue [i.e., additive be approved] if a fair evaluation of the data before the Secretary fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe ...."73 Initially, the FDA defined safety as follows: "'Safe' means that there is convincing evidence which establishes with reasonable certainty that no harm will result from the intended use of the food additive."74 Faced with reviewing chemicals for the GRAS list that contained many items for which scant, controversial, or no evidence existed, the FDA redefined "safe" [28 ELR 10012] saying, "'Safe' must be understood to connote that the [FDA], after reviewing all available evidence, can conclude there is no significant risk of harm from using the substance as intended."75 This second definition allows untested or only partially tested chemicals to be added to the food supply, while the former definition required the initial presentation of some convincing evidence of safety.
The FDA and, in the case of pesticides, EPA still struggle to solve scientific controversies about safety with legal tools. Two complicating facts underlie this struggle. First, when scientists agree that the use of a chemical is either safe or unsafe, no controversy about that use erupts. Only when a scientist challenges the label of "safe" attached to the use of a chemical or class of chemicals by other scientists does the balancing mechanism engage. Otherwise, chemicals enter or remain outside the food supply virtually unnoticed. When there is a controversy, the FDA and/or EPA can only resolve it by overruling one set of scientifically supported arguments with a legal or regulatory judgment.
Second, the food and drug laws use the word "safety" to denote two distinct concepts. "Safety" in the law includes both the scientific observation that a chemical causes no damage to humans and the policy judgment that even though a chemical might injure a human, the benefits it imparts outweigh any damage it might cause. Only the Delaney Clause of the FFDCA escapes this pitfall by avoiding any reference to either concept of safety. Instead, it allows scientists to ascertain the risk presented by the use of a particular chemical (does it cause cancer in animals?) and assigns policymakers (Congress) the task of judging whether the scientifically defined risk is acceptable to society. For this reason, it serves as a model for environmental protection legislation.
The Delaney Clause Solution to the Proof-of-Safety-Problem
The Food Additives Amendment of 1958 contains three distinct attempts to alleviate the FDA's burden-of-proof problem: (1) the GRAS approach that resulted in the GRAS list of chemicals approved by the FDA for addition to foods;76 (2) the Delaney "anti-cancer" Clause that bans from food any substance that causes cancer when fed to animals;77 and (3) the administrative structure designed by the FDA to evaluate item-by-item any chemicals that do not fall into either category one or two.78 Each of these three legal stratagems sought to circumvent the problem of scientific uncertainty. Only the Delaney Clause succeeded.
Legislation that effectively controls chemical contamination of the environment must seek to block the use of substances that present undue risk without putting unreasonable restraints on chemicals that provide important benefits to the public. Neither the GRAS procedure nor the item-by-item administrative structure proved effective in insuring that only "safe" chemicals were added to, and "unsafe" chemicals were banned from, the food supply. To establish an initial GRAS list, the FDA surveyed 900 scientists, of whom 350 replied and 194 endorsed the entire proposed list of about 200 items. The selection process was imperfect. The FDA dismissed the complaints of a number of scientists against safrole,79 vitamin D, and cyclamate, only to find it necessary to act against these challenged chemicals in subsequent years.80
Under this pick-and-choose procedure, the basic GRAS list grew to approximately 700 items with various loopholes and exceptions, allowing as many as another 1,000 items to be treated as GRAS.81 Facing two years of research before approval, food manufacturers asserted or sought GRAS recognition for their chemicals.82 By the end of 1970, the situation had become so unwieldy that the agency moved to revise the entire GRAS procedure by attempting to reintroduce suspect chemicals currently on the GRAS list into the chemical-by-chemical investigation,83 and contracted, as a result of a presidential executive order, for a review of every item on the list. Completed in the early 1980s, this review failed to totally endorse as safe about 10 percent of currently listed GRAS items.84
Like the GRAS approach, the chemical-by-chemical additive procedure relies on the ability of scientists to distinguish [28 ELR 10013] safe from unsafe substances. In the fall of 1969, when the government removed cyclamate from the GRAS list, Food and Drug Commissioner Charles C. Edwards expressed a common misunderstanding of the Delaney Clause, saying:
My personal view and that of the FDA is that we have to have more flexibility of interpretation or we are put into the position that we were with cyclamatesall or nothing. And it becomes a highly emotional issue at that point, allowing no discretion on our part or anyone else's.85
This statement implies that but for the Delaney Clause, the FDA would have allowed cyclamates to remain in the food supply, in some amount even though this chemical causes cancer in rats. The Commissioner's characterization of the Delaney Clause as a usurpation of administrative discretion is incongruous because other parts of this food protection law, although operating more slowly than the anti-cancer clause, also would have required cyclamates to be completely banned from the food supply. The sponsors of cyclamates have tried repeated and unsuccessfully since 1970 to persuade the FDA that their product can be safely added to the food supply. At the onset of the cyclamate controversy, the chemical was generally recognized as safe by the FDA. After a substantial safety question was raised, the Secretary officially removed cyclamates from the GRAS list. At this point, the law, absent the Delaney Clause, requires that the chemical be shown to be safe before a petition can be granted allowing its addition to food.86 Cyclamate has been unable to meet this burden of proof. Clearly the Delaney Clause was not necessary to remove the chemical from the food supply. In fact, some of the most vigorous critics of the Delaney Clause call it an unnecessary duplication of already existing authority.
When the FDA Commissioner asks for "discretion" to decide when a chemical that causes cancer in animals can still be used in food for people, the Commissioner is asking for the discretion to decide an issue that thousands of cancer researchers have been unable to resolve. The dangers of this position are put forth accurately by restating former Secretary of HEW Arthur S. Flemming's statement that:
The rallying point against the anticancer provision is the catch phrase that it takes away the scientist's right to exercise judgment. The issue thus made is a false one, because the clause allows the exercise of all the judgment that can safely be exercised on the basis of our present knowledge. The clause is grounded on the scientific fact of life that no one, at this time, can tell us how to establish for man a safe tolerance for a cancer-producing agent. As I pointed out in my original testimony, the opposition to inclusion of an anticancer clause arises largely out of a misunderstanding of how the provision works. It allows the Department and its scientific people full discretion and judgment in deciding whether a substance has been shown to produce cancer when added to the diet of test animals. But once this decision is made, the limits of judgment have been reached and there is no reliable basis on which discretion could be exercised in determining a safe threshold dose for the established carcinogen.87
The Delaney principle assigns scientific judgments that is, the apparent facts to scientists, and policy determinations meaning how much risk to allow and who should decide to policymakers. In approaching the safety question this way, the Delaney Clause avoids the vexing proof-of-safety problem and serves as a model for creating and/or evaluating environmental regulation. Unfortunately, the intersection of Delaney and pesticide residues created more confusion than clarity about regulating the safety of such residues in food.
The Delaney Paradox Revisited: Alleged Problem, Misleading Answer
EPA describes the Delaney Paradox saying:
EPA regulates pesticide residues in foods under the [FFDCA]. The FFDCA gives EPA the authority to set legally enforceable limits, or tolerances, for pesticide residues in food. EPA sets tolerances for pesticide residue remaining in raw foods under section 408 of the FFDCA. Under section 409 of FFDCA, EPA sets food additive tolerances for pesticide residues that concentrate in processed foods above raw tolerances, or are the result of pesticide application during or after food processing. Section 408 and section 409 contain different legal standards for determining whether a tolerance may be established. Section 408 allows EPA to consider benefits of an adequate, wholesome, and economical food supply in setting tolerances. The "Delaney Clause" of section 409, however, generally prohibits EPA from establishing a tolerance for any food additive that induces cancer, no matter how small the risk may be to consumers.88
The EPA interpretation turns Congress' pesticide-residue policy on its head. As the court pointed out in Les v. Reilly,89 Congress created a pesticide-residue system permitting residue tolerances for raw agricultural commodities and specifically provided that those tolerances also applied to processed food.90 The actual pesticide-residue issue raised by the Delaney Clause is: under what circumstances, if any, should the tolerance for a pesticide in a processed food be allowed to exceed the tolerance of that pesticide established for the food as a raw agricultural commodity?
EPA and other critics of the Delaney Clause prohibition on cancer-causing pesticide residue above the tolerance for a raw agricultural commodity argue that because of the clause, "a risk that is negligible or insignificant cannot be [28 ELR 10014] taken into account."91 Critics always couch the assault on Delaney in terms of "negligible or insignificant" risk that EPA could not take into consideration. This alleged limitation on EPA, the critics charged, spelled disaster for American agriculture.
The President of the American Farm Bureau Federation, Dean Kleckner, testified to the Senate Agriculture Committee that "the long-awaited Delaney disaster has begun for U.S. farmers," and cited examples.92 Thirty-nine percent of Virginia's apple acreage treated with dicofol for mite control; 42 percent of Texas' soybean acreage treated with alacholor for weed control; 2,200 acres of oats in Nebraska treated with mancozeb for control of leaf spot, tan spot, and glume blotch; 85,000 acres of wheat in Arkansas and 114,200 acres of wheat in North Dakota treated with mancozeb; 18 percent of Alabama and Georgia wheat crops treated with triadimefon for powdery mildew and speckled leaf sot control; 216,000 acres of grapes in California treated with triadimefon for mildew control; 18,000 peanut acres in Virginia treated with iprodione for control of sclerotinia blight; and half the grape acres in Oregon treated with iprodione for control of bunch rot. All of these and many, many more crops would be lost because of Delaney, the critics asserted.93
Mr. Kleckner and other critics made these dire predictions in spite of the fact that the pesticide law clearly authorized EPA to grant tolerances taking into consideration "the necessity for the production of an adequate, wholesome, and economical food supply"94 that flowed through to the processed foods made from the raw agricultural commodities in question.95 For example, on January 13, 1993, the Mancozeb Task Force, which included E.I. Du Pont de Nemours & Co., Elf Atochem North America, Inc., and Rohm and Haas Co., asked EPA to withdraw its stayed ban on mancozeb in raisins, and the bran of barley, oats, rye and wheat.96 On June 30, 1994, EPA granted the request for raisins, stating:
EPA agrees with the petitioner's assertion that the food additive regulation for mancozeb on raisins is not needed since the data show the levels of mancozeb on typically processed raisins are lower than those in the unprocessed grapes. The study used as the basis for setting the original food additive regulation was not reflective of the current typical processing practices which include washing of raisins ....97
Regulations stopping the other uses of mancozeb, except for bran of barley, remained stayed at the time of the passage of the FQPA.
Once EPA recognized that Delaney did not preclude residues of cancer-causing pesticides in processed foods, it seems a short step to including consideration of the effect of negligible- or de minimis-risk residue in processed food on "the necessity for the production of an adequate, wholesome, and economical food supply" when establishing raw agricultural-commodity tolerances. As Al Meyerhoff, General Counsel of the Natural Resources Defense Council (NRDC), which initiated the petitions and lawsuits that created the context for the FQPA, has stated:
One of the weaknesses in both the settlement and the law was that in order to avoid the Delaney trap, all you needed to be able to show is that the amount in the processed food could be less than the amount in the raw agricultural commodity. The other flaw here is that typically EPA set tolerances in raw agricultural commodities way higher than residues, sometimes 100 times higher.98
All that EPA had to do was increase any raw agricultural-commodity (RAC) tolerance by the additional amount of residue in a processed food that it believed created a negligible or de minimis risk. Conversely, proponents of a cancer-causing pesticide could, as the raisin processors did with mancozeb, institute procedures that reduced the amount of the cancer-causing pesticide in processed food below the corresponding RAC tolerance.
EPA's action on mancozeb in raisins illustrates how little the Delaney Clause tied EPA's hands. Indeed, it throws into doubt the very notion that a Delaney Paradox existed. The confusion about Delaney appears in the NAS study that coined the term Delaney Paradox.99 Commissioned by EPA in 1985, and completed in May 1987, this study rests on the assertion that the Delaney Clause prohibits "the establishment of any processed-food tolerances for an oncogenic pesticide (a pesticide capable of inducing tumors), regardless of whether or to what extent its residue is judged to pose a hazard to human health.100 The report claims that "the EPA has interpreted the Delaney Clause" in this manner and that "it is this policy that has occasioned the current study."101
The persistent repetition of the assertion that the Delaney Clause precluded any amount of residue of a cancer-causing pesticide in processed foods clouds the debate from the drafting of the NAS report to the passage of the FQPA. Four distinct references to the application of Delaney in the NAS report the one above and three others illustrate, and perhaps act as the origin for, the misunderstanding. In Appendix A of the report, Bruce S. Wilson describes the Delaney "anomaly," stating:
Section 402 of the Food Drug and Cosmetic Act ... includes a "flow-through" provision under which approval of a tolerance for pesticide residue in a raw agricultural commodity under the terms of section 408 serves as substitute approval of the residue in processed food under section 409. If the concentration of the residue in the processed food is still below section 408 tolerances, then no independent section 409 approval is required.
The standards for approval under sections 408 and 409 are markedly different, however. Section 408 uses a type [28 ELR 10015] of risk/benefit balancing weighing the need for an adequate food supply against the need to protect the consumer's health. Section 409 included the "Delaney Clause," which flatly prohibits approval of a food additive found to induce cancer in humans or animals.
The combination of the section 402 "flow-through" provision and the different standards in sections 408 and 409 creates an anomalous situation whereby a potentially carcinogenic pesticide residue can become a lawful additive to food in spite of the Delaney Clause. As long as the residue does not exceed the section 408 tolerance, the pesticide need not meet the more exacting Delaney standard found in section 409. This anomaly has become increasingly significant in recent years, because some previously approved pesticides have proved carcinogenic in animal studies.102
The executive summary of the report states:
Pesticide residues that concentrate in processed food above the level authorized to be present in or on their parent raw commodities are governed by the [FFDCA's] section 409, the law governing food additives ... section 409 contains the Delaney Clause. This clause prohibits the approval of a food additive that has been found to "induce cancer" ... in humans or animals.103
The preface of the report states, "The [Delaney] clause purports to bar EPA from granting any tolerance for a pesticide residue that has been found to induce cancer in animals and that concentrates in processed food."104
The distinction between these four statements plus the title of the report, Regulating Pesticides in Food: The Delaney Paradox, underscore the Delaney confusion. The contrast between the preface's alleged ban on "any tolerance" of a pesticide residue in processed food and the executive summary's accurate statement of the law's ban on pesticide residues in processed food above the amount allowed in RACs raises a red flag. The contrast between the report's "paradox" and the appendix's "anomaly" drives the point home. The "anomaly," as described, allows cancer-causing pesticide residues in processed foods in spite of the Delaney Clause. The "paradox" prohibits any residue of cancer-causing pesticides in processed but not raw food because of Delaney. The law itself very consistently says that RACs and processed-food tolerances will be identical. The NAS conducted an evaluation of the costs and benefits of the operation of the Delaney Clause apparently using models based on the zero-tolerance interpretation contained in the preface of the report. The estimates of cost of Delaney would have been significantly lower if the models had focused on the pesticide residue in processed foods that exceeded RAC tolerance for that food. Furthermore, nothing in the law prohibited EPA from balancing such costs (which it claimed to be negligible) against the benefits that sponsors claimed to be plentiful when establishing RAC tolerances that would pass through and become processed-food tolerances.
The report found that the foods "whether marketed in raw or processed form or governed by old or new tolerances, should be regulated on the basis of consistent standards. Current law and regulations governing residues in raw and processed food are inconsistent with this goal."105 The report did not explain why requiring the same tolerance for raw and processed food was inconsistent with the recommended policy. The report did not comment on the statement of the law contained in its appendix A. It recommended a negligible risk standard for carcinogens in food the de facto policy followed by EPA before it commissioned the report. It recommended that EPA focus its attention on the 28 most carcinogenic pesticides and adopt an analytic (mathematical model) framework to carry out the recommended tasks. The report recommended a formula calling for the revocation of tolerances where the combined estimated cancer risk for raw and processed forms of a food exceeded one in one million, which it said would reduce the estimated cancer risk from the 28 most oncogenic pesticides by 98 percent and require the revocation of 32 percent of the tolerances for these compounds. While there does not seem to be anything in the law that would have precluded EPA from adopting the report's recommendations, the report armed the Agency with the arguments it needed to announce an end to what it believed was a zero-tolerance Delaney legal requirement and replace it with its negligible-risk policy.
On October 19, 1988, EPA issued its new negligible-risk (one-in-one-million) pesticide-residue policy for both § 408 and § 409 tolerances.106 Pesticides with a quantified risk of more than one in one million, whether in RACs or processed foods, would be granted tolerances if their benefits exceeded their risks, provided that processed-food tolerances were not required, in which case EPA determined that Delaney would prohibit all uses. This odd interpretation of the law angered both pro- and anti-Delaney advocates.
Anti-Delaney advocates argued that the total ban on pesticides with more than a one-in-one-million risk of cancer from both raw and processed foods would lead to an agricultural catastrophe. Pro-Delaney advocates argued that the law did not allow a one-in-one-million risk of cancer for any pesticide residue subject to the Delaney Clause. Both arguments were somewhat disingenuous, since EPA could have adopted a standard for § 408 RAC tolerances that balanced risks and benefits as the NAS recommended, and those tolerances would, under the law, have become the legal § 409 tolerances. This strategy would avoid whatever "catastrophe" might occur while not violating the Delaney Clause as it applied to pesticide residue in processed foods.
Instead of conforming its policy to the law, EPA chose a strategy that fomented legal reactions from both Delaney supporters and critics. In May 1989, the NRDC, the state of California, Public Citizen, the AFL-CIO, and several individuals petitioned EPA to revoke 14 food-additive tolerances for pesticide residues in processed foods as inconsistent with the zero-risk Delaney standard.107 Simultaneously, the state of California and a number of allies filed suit in the U.S. District Court for the Eastern District of California, seeking to force EPA to revoke § 409 tolerances for cancer-inducing pesticides on processed foods as a violation [28 ELR 10016] of the Delaney Clause and to revoke the associated § 408 tolerances. The NRDC petition began a series of legal steps that ended with the passage of the FQPA, supported by the NRDC and its environmental allies.
First, EPA issued an April 1990 preliminary decision revoking six of the tolerances attacked by the NRDC, but refused to act on the other eight. Then, in 1991, it issued a final order refusing to revoke four of the tolerances because they met the Agency criteria for de minimis risk, removing them from the reach of the Delaney Clause. The EPA de minimis strategy involved the same approach to pesticide residue that the FDA had tried and lost in court on color residues. The NRDC and its allies sued EPA Administrator William Reilly on the de minimis interpretation in the Ninth Circuit. The Delaney supporters now had two cases in court.
On July 8, 1992, Judge Schroeder issued the Ninth Circuit's opinion in Les v. Reilly, ruling that the law did not permit the EPA de minimis policy and saying:
The EPA's refusal to revoke regulations permitting the use of benomyl, mancozeb, phosmet and trifluralin as food additives on the ground the cancer risk they pose is de minimis is contrary to the provisions of the Delaney Clause prohibiting food additives that induce cancer. The EPA's final order is set aside.108
With the EPA de minimis policy dead, the National Food Processors Association (NFPA) and a number of grower groups petitioned EPA for various ameliorating interpretations of the application of Delaney concerning the Agency's concentration, coordination, ready-to-eat, and testing policies.109 At the same time, spurred by the Reilly decision, EPA began negotiations to settle California v. Browner, the second court case challenging its Delaney policies. On October 14, 1994, the parties in this case proposed a settlement agreement (ratified by the court in February 1995), which called for EPA to carry out the Reilly mandate for the strict application of the Delaney Clause and to answer the NFPA petition. It agreed to do this by accepting a strict timetable to review all pesticides that might be subject to the Delaney Clause. It agreed to answer the petition within 60 days and to review the following three sets of pesticide tolerances:
While negotiating the consent decree, EPA Administrator Carol Browner made clear that it addressed only a small part of the need to reform the pesticide safety laws.111 This broader approach to reform of pesticide law received more momentum from the 1993 report of the National Research Council, Pesticides in the Diets of Infants and Children, which concluded that the current regulatory system in the United States did not adequately protect infants and children against pesticides in the diet. It recommended improvement in the "methods for estimating exposure and for setting tolerances to safeguard the health of infants and children."112 A 1996 National Research Council study, Carcinogen and Anti-carcinogens in the Human Diet, also fed the debate. It concluded in part that "it is difficult to assess human cancer risk from individual natural or synthetic compounds in our diet because the diet is a complex mixture, and interactions between the components are largely unknown."113
The energy generated by the children's study combined with the anti-Delaney momentum to create the political coalition that passed the FQPA, which created a new framework for pesticide regulation. The Act redefined "food additive" and "pesticide chemical residue," eliminating the Delaney Clause application to residues above a § 408 tolerance, and amending § 408 to establish a new safety standard requiring that for all pesticides, "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."114
[28 ELR 10017]
The House Commerce Committee report on the bill further elaborated on safety, stating, "The committee further expects, based on its understanding of current EPA practice, that the administrator will interpret an ample margin of safety to be a 100-fold safety factor applied to the scientifically determined 'no observable effect' when data are extrapolated from animal studies."115 Where data failed to establish a "no observable effect" level (a category that, at a minimum, includes carcinogens covered by Delaney), the committee accepted a "negligible," one-in-one-million lifetime cancer risk. The committee also reinforced EPA's responsibility for maintaining and updating its risk assessment methodology and modifying its interpretation of "reasonable certainty of no harm," cautioning that any new interpretations "must be scientifically based and the administrator should bear the burden to demonstrate that the revised interpretation is equally protective of the public."116
The new law also added new requirements for the protection of infants and children. EPA tolerance decisions must include consideration of consumption surveys to see if infants and children are likely to consume more of the pesticide than adults, data on special neurological and in utero susceptibility of infants and children to pesticide residues, and cumulative effects on infants and children of different pesticides that have a common mechanism of activity. The law requires EPA, the Department of Health and Human Services, and the USDA to survey the exposure of infants and children to pesticide residue and to apply an additional 10-fold safety factor unless the survey data establishes it as unnecessary. The committee report endorsed an additional 10-fold safety factor whenever studies showed fetal-development effects or postnatal-development toxicity or the effects-on-children data are incomplete.
The statute includes nine additional general criteria that EPA must consider in granting an exemption or establishing, revising, or revoking a tolerance: the validity, completeness, and reliability of data on risk; the nature of any toxic effect; the soundness of data and their relevance to human risk; dietary consumption patterns; cumulative effects and common mechanisms of toxicity; cumulative exposure levels from all nonoccupational sources; susceptibility of identifiable subgroups of consumers; similarity of effect to effects of naturally occurring estrogen or other endocrine effects (the law mandates implementation of an endocrine screening program within three years); and safety factors generally recognized as appropriate for animal testing.117
The FQPA also includes a consumers "right-to-know" provision requiring EPA to "publish and distribute to large retail grocers for public display," pesticide-residue information understandable to ordinary shoppers including risks and benefits, residues above the "safe" level and foods on which they are used, and recommendations to consumers on how to avoid pesticide residues while maintaining a safe diet. It also limited the rights of state and local authorities to set their own pesticide-residue tolerances (but preserved their right to issue warnings); required the review of all existing tolerances to be completed within 10 years; and addressed various administrative matters such as registration fees and reviews, training, penalties and minor-use pesticides.118
Industry groups hailed the "end of Delaney" in pesticide regulation and expressed a wait-and-see attitude about the new framework. Environmental groups regretted the "loss" of Delaney but hailed the infants and children protections; the general safety standard covering both raw and processed foods; the expansion of the safety standard beyond Delaney-covered cancer to nerve damage, reproductive failure, and birth defects; endocrine screening; "right-to-know"; and the reassessment schedule for current tolerances. At the bill signing ceremony, President Clinton hailed the new law as "long overdue" and as setting "a clear, consistent standard for all pesticide use on all foods for all health risks,"119 never mentioning the Delaney Clause.
On August 4, 1997, EPA announced its Raw and Processed Food Schedule for Pesticides Tolerance Reassessment.120 The announcement sets out a review schedule for 9,728 tolerances and exemptions, the first third by August 1999, the second third by August 2002, and the final third by August 2006. All the tolerances or exemptions contained in the settlement of California v. Browner121 appear to be on the list, and the timetable for review is comparable to the settlement.
The FQPA, like most legislation, involved trade offs for all stakeholders. The details of the new framework, including many reforms long sought by environmental groups, provide the balance for the widely publicized elimination of the Delaney "anti-cancer" Clause banning residue of cancer-causing pesticides in processed foods at a level above the amount allowed in raw agricultural commodities.
Delaney critics such as the presidents of the American Crop Protection Association and the NFPA hailed the end of the obsolete science of the Delaney Clause. Al Meyerhoff of the NRDC said, "We now have a big new hammer. We had a big hammer with Delaney, now we have a new one."122 Time will tell which parties the trade offs satisfy most.
In the summer of 1996, the press, spurred on by members of the 104th Congress, hailed the end of the Delaney "anti-cancer" Clause which, they said, stopped the government from allowing even minute amounts of residue of cancer-causing pesticides in processed food. In fact, from 1947, when Congress first passed a law regulating pesticide residue, to the 1996 passage of the FQPA, the law allowed residues of cancer-causing pesticide in both processed foods and raw agricultural commodities.
The law did ban and continues to ban, through the operation of the Delaney Clause for food additives, color [28 ELR 10018] additives, and animal drugs, any residue of cancer-causing chemicals in food from these sources. It did not ban residues of cancer-causing pesticide in processed food unless they exceeded the tolerance adopted by the government, in a process that weighed the risks and benefits of pesticide use, for raw agricultural commodities. It accomplished this legal outcome by excluding from the definition of "food additives," to which the Delaney Clause applies, pesticide residues in processed food equal to or smaller than those allowed by law in raw agricultural commodities.
The environmentalists' debate over whether to embrace or denounce the 1996 changes in the pesticide law because that law repealed Delaney is off the mark. Delaney lives. It continues to prohibit residues of cancer-causing chemicals intentionally added to food as it always did. With regard to pesticides, the FQPA eliminated the ban on residues of cancer-causing pesticide above a raw agricultural-commodity tolerance and created a new safety standard (including a risk of one-in-one-million cancers over a lifetime) that applies to both raw agricultural commodities and processed foods. EPA could have applied this standard under the law as it existed before the FQPA.
Adversaries can and will debate whether a zero tolerance is better than a one-in-one-million tolerance. It is not accurate to say, however, that the new law replaced a zero tolerance for residues of cancer-causing pesticides with a one-in-one-million safety standard. It is equally inaccurate to suggest that the FQPA provides a direct precedent for dealing with the food-additive applications of the Delaney Clause. The Delaney Clause as it appears in the FFDCA does require a zero tolerance for cancer-causing chemicals intentionally added to food. The trade-offs present in the pesticide law are absent from a consideration of the food-additive, color-additive, and animal-drug laws.
In 1973, Philip Handler, President of the NAS, who had the reputation of being a Delaney critic, summarized a daylong NAS conference, How Safe Is Safe? The Design of Policy on Drugs and Food Additives, which included discussion of the Delaney Clause. He said:
The Delaney Clause was discussed in several ways. I am pleased that it did not become the focus of this day's discussion. For my part, I begin to view that clause as a great red herring rather than as a problem in our society. Certainly, on its face, all other things being equal, it is a perfectly rational guide to desirable societal behavior. No one in his right mind wants to put carcinogens into anything intended for human consumption. We should be perfectly willing to accept that guideline until the day when we find ourselves in the position of banning as a carcinogen some chemical entity which also offers great benefits. Until that time comes, we will not have to test the validity of the Delaney principle. When it does, we will have no recourse but to test the validity of the principle in a real life situation.123
As Dr. Handler pointed out, the Delaney Clause addresses the question, of who will decide if and when to permit the addition of carcinogens to food by saying it is too important a question to leave to regulators alone. In the 1950s, Congress made an exception to this answer for pesticides. The 1996 FQPA refined that exception while leaving the Delaney Clause unchanged. [28 ELR 10019]
RAW CROP (408) CFR PROCESSED (409) CFR
PESTICIDE CITATION FOOD/FEED (409) CITATION Acephate Cotton (180.108) Seed hulls 186.100
Soybeans (180.108) Meal 186.100
Not applicable Food hand. estab. 185.100
Benomyl Apples (180.294) Pomace 185.350
Citrus (180.294) Pulp 186.350
Grapes (180.294) Pomace 186.350
Rice (180.294) Hulls 186.350
Tomatoes (180.294) Puree or catsup 185.350
Captan Grapes (180.103) Raisins 185.500
Carbaryl Pineapples (180.169) Bran 186.550
Diflubenzuron (metab.: Soybeans (180.377) Hulls 186.2000
p-chloroaniline) Soap stock
Dimethipin Cotton (180.406) Seed hulls 186.2050
Dimethoate Citrus (180.204) Pulp 186.2100
Ethylene Oxide Whole Ground spices 185.2850
Imazalil Citrus Citrus oil 185.3650
Citrus pulp (dried) 186.3650
Iprodione Grapes (180.399) Raisins 185.3750
Raisin waste 186.3750
Ginseng (180.399) Dried Ginseng 185.3750
Peanuts (180.399) Soap stock 186.3750
Rice (180.399) Bran 186.3750
Mancozeb Barley (180.176) Bran 185.6300
Oats (180.176) Bran 185.6300
Rye (180.176) Bran 185.6300
Wheat (180.176) Flour 185.6300
Milled fractions 186.6300
Norflurazon Citrus (180.356) Pulp 186.4450
Oxyfluorfen Cotton (180.381) Seed oil 185.4600
Peppermint (180.381) Oil 185.4600
Spearmint (180.381) Oil 185.4000
Soybean (180.381) Oil 185.4600
Propargite Apples (180.259) Pomace 186.5000
Citrus (180.259) Pulp 186.5000
Figs (180.259) Dried figs 185.5000
Grapes (180.259) Raisins 185.5000
Not applicable Dried tea 185.5000
Propylene oxide Not applicable Cocoa 185.5150
Simazine Sugarcane (180.213) Molasses 185.5350
Tetrachlorvinphos Not applicable Feed items 186.950
Thiodicarb Cottonseed (180.407) Hulls 186.5650
Soybeans (180.407) Hulls 186.5650
Thiophanate methyl Apples (180.371) Pomace 186.5700
Triadimefon Apples (180.410) Pomace 186.800
Barley (180.410) Milled fractions 185.800
Grapes (180.410) Pomace 186.800
Raisin waste 186.800
Wheat (180.410) Milled fractions 185.800
PESTICIDE RAW CROP (408) CFR CITATION
Acephate Cotton (180.108)
Alachlor Peanuts (180.249)
Sunflower seed (180.249)
Asulam Sugarcane (180.360)
Atrazine Sugarcane (180.220)
Benomyl Apples (180.294)
Captan Grapes (180.103)
Plums (fresh prunes) (180.103)
Carbaryl Pineapples (180.169)
Chlorothalonil Potatoes (180.275)
Dichlorvos (DDVP) Soybeans (180.235)
Dicofol Apples (180.163)
Plums (fresh prunes) (180.163)
Diflubenzuron (metab.: p-chloroaniline) Soybeans (180.377)
Dimethipin Cotton (180.406)
Dimethoate Citrus (180.204)
Ethylene Oxide Whole spices (180.151)
Imazalil Citrus fruit (180.413)
Iprodione Grapes (180.399)
Lindane Tomatoes (180.133)
Linuron Potatoes (180.184)
Mancozeb Barley (180.176)
Sugar beets (180.176)
Maneb Apples (180.110)
Sugar beets (180.110)
Methidathion Citrus (180.298)
Methomyl Wheat (180.253)
Metiram Apples (180.217)
Sugar beets (180.319)
Metolachlor Peanuts (180.368)
Norflurazon Citrus (180.356)
Oxyfluorfen Apples (180.381)
PCNB Potatoes (180.319)
Permethrin Tomatoes (180.378)
Phosmet Citrus (180.261)
Propargite Apples (180.259)
Simazine Sugarcane (180.213)
Thiodicarb Cottonseed (180.407)
Thiophanate methyl Apples (180.371)
Triadimefon Apples (180.410)
Trifluralin Potatoes (180.207)
Acifluorfen Maneb (metab.: ETU)
Amitraz Metiram (metab.: ETU)
Atrazine Methomyl (metab.: Acetamide)
Benomyl (metab.:MBC) Methylene chloride (dichloromethane)
Cacodylic acid O-phenylphenol
Cypermethrin Pentachloronitrobenzene (PCNB)
Dimethipin Propylene oxide
Ethylene oxide Thiodicarb (metab.: Acetamide)
Etridiazole Thiophanate methyl (metab.: MBC)
Imazalil Triphenyltin hydroxide
... Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, 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 animal, except that this provision shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subjected to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal.
A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive if after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided that clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal.
Pesticide residue that concentrates in processed food above the level authorized to be present in or on their parent raw commodities are governed by the [FFDCA's] section 409, the law governing food additives ... section 409 contains the Delaney Clause. This clause prohibits the approval of a food additive that has been found to "induce cancer" ... in humans or animals.
Id. preface & 161-63 (emphasis added). The distinction between the preface's alleged ban on "any tolerance" of a pesticide residue in processed food and the executive summary's accurate statement of the law's ban on pesticide residues in processed food above the amount allowed in raw agricultural commodities, lies at the heart of the misstatement of the issue to and by the press. For further discussion of this point, see infra notes 12-20 and accompanying text.
The flow-through provisions are contained in section 402 which provides:
That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title [FFDCA section 408] and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such process food shall, notwithstanding the provisions of sections 346 and 348 of this title [FFDCA sections 406 and 409], not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity.
The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include -
(1) a pesticide chemical in or on a raw agricultural commodity; or
(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity; or
(3) a color additive; or
(4) [a prior sanctioned chemical]; or
(5) a new animal drug.
21 U.S.C. § 321(s). Interestingly, H.R. 1627, as passed by the 104th Congress appears to have abolished the prior sanction exemption.
The compromise (leading to the passage of the Food Quality and Protection Act) addresses the deadlock between the industry who oppose the Delaney clause and the organizations that support better protection for children and public health, by establishing a comprehensive federal program to make pesticide levels in food and the environment safe for infants and children. The bill establishes a health-based standard and a strict timetable for pesticide tolerance setting that adheres tightly to the recommendations of the 1993 National Academy of Sciences Committee Report on Pesticides in the Diets of Infants and Children. Importantly the tradeoff about which the groups expressed reservations already existed in the pesticide law.
Section 409 (c)(3)(A) (21 U.S.C. 348 (c)(3)(A)) is amended by striking all after "substance" and inserting "that presents a negligible or de minimis risk"; Section 512(d)(1)(I) (21 U.S.C. 360b(d)(1)(I)) is amended by striking everything after "if" and inserting "if such drug presents a negligible or insignificant risk to humans or animals"; and, Section 721(b)(5)(B) (21 U.S.C. 379e(b)(5)(B)) is amended by striking all after "with respect to the use of a color additive" and inserting "if such color additive presents a negligible or insignificant risk to humans or animals."
H.R. 3200, 104th Cong. § 107 (1996).
18 ELR 20173,
http://www.elr.info/litigation/vol18/18.20173.cfm#20174 20174(D.C. Cir. 1987).
Congress determined that since cancer scientists cannot say at what level a carcinogen is "safe" the country should not suffer any risk of cancer from chemicals deliberately added to food. The judgment has so far not been extended to pesticides, carcinogens in the workplace or water supply, drugs or other consumer products, presumably because the benefit-risk balance is more complex.
ANITA JOHNSON, ESQ., CANCER PREVENTION AND THE DELANEY CLAUSE (Ralph Nader's Center for the Study of Responsive Law 1972) (emphasis added).
My proudest possession is the following citation from Jim Delaney which hangs framed in my library. "August 15, 1958, Dear Miss Swanson: I am sure you will be interested to know that chemical additive legislation was passed by the House on Wednesday. The enclosed pages from the Congressional Record will give you details.
"While the committee bill which was passed was not all that I wanted, it is a definitive step forward and will afford the public appreciably improved protection. I insisted upon, and succeeded in getting the committee to accept, an amendment prohibiting the use in food of any cancer-inducing chemical one of the strong features of my bill.
"Your own personal campaign for additive legislation was of great help. After you addressed the Congressional wives here in Washington, many members spoke to me about the deep impression you had made. Your many radio and television appearances and your speeches around the country did much to alert the public to the hazards of insufficiently tested chemical additives and the need for regulatory legislation. I know that the thousands of letters which poured into congressional offices here had their effect in helping bring about Wednesday's action.
"A bill now goes to the Senate, and though adjournment seems near, I believe there will be time to push it through. I am most grateful to you for the valuable contribution you have made to this cause. With kindest regards, I am Sincerely, James J. Delaney, M.C."
Id. at 513.
(f) Where raw agricultural commodities having residues that have been exempted from the requirement of a tolerance, or which are within a tolerance permitted under section 408 are used, the processed food will not be considered unsafe within the meaning of section 406 if:
(a) the poisonous or deleterious pesticide residues have been removed to the extent possible in good manufacturing practice; and
(b) the concentration of the pesticide in the preserved or processed food when ready to eat is not greater than the tolerance on the raw agriculture commodity.
In promulgating such regulations this section requires that there be taken into account the extent to which the use of the poison is required in the production of the article, as for example, poisonous sprays in producing certain fruits and vegetables, and likewise, the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. This authorization will permit the establishment of comparatively liberal tolerances for any food where poison is unavoidable or is required by the necessities of production, and less liberal tolerances or complete prohibitions where it is practicable to limit the amount of poison in a particular food to [very] small quantities, or to eliminate it completely. It will likewise afford adequate control of those situations where irresponsible manufacturers, for some fancied or real commercial advantage, add dangerously toxic substances to foods, as, for example, the addition of maleic acid to fats and oils to prevent rancidity when preservation can be accomplished by observance of sanitary conditions in manufacture and packaging and by use of refrigeration for the finished product.
S. REP. No. 73-493, at 4 (1934).
A food shall be deemed to be adulterated
...(a)(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agriculture commodity; (ii) a food additive; or (iii) a color additive) which is unsafe within the meaning of section 346 ... or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of 346a(a) ... or (C) if it is, or it bears or contains, any food additive which is unsafe within the meaning of section 348 ....
Such [a] requirement is basically a pre-testing one for new food additives.... Whereas the [FFDCA] now prohibits a food that is unsafe, this prohibition normally applies after the food is sold and consumed, and its enforcement may be long delayed for various reasons.... Moreover in such an enforcement proceeding the Government has the burden of proving that the food is unsafe, whereas this requirement would instead compel the manufacturer of a food to prove in advance that it is safe.
Hearings on H.R. 8112, Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 85th Cong. 50 (1957-1958).
[A] color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term "food additive" because of its being generally recognized by qualified experts as safe for its intended use, as provided in Section [32 (I)(s)].
Color Additive Amendments of 1960, Pub. L. No. 86-618, § 103(b), 74 Stat. 399 (codified as amended at 21 U.S.C. § 376(b)(4)).
28 ELR 10003 | Environmental Law Reporter |