Source: http://www.wnho.net/delaney_lives.htm
Timestamp: 2019-04-21 00:59:12+00:00

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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Congress passed the Food Quality Protection Act of 1996 (FQPA), many in the press announced that this law effectively repealed the Delaney Clause, which they claimed had banned all traces of cancer-causing pesticides in processed foods.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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)."
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 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.
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.
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 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.
Regulations stopping the other uses of mancozeb, except for bran of barley, remained stayed at the time of the passage of the FQPA.
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.
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 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.
The consent decree reflected actions that EPA had been taking since the Reilly decision. In February 1993, the Agency listed 32 pesticides with about 80 tolerances it said could be affected by the decision. A year later, it updated the list to 34 pesticides with about 100 tolerances. In July 1993, it ordered revocation of § 409 tolerances for four pesticides named in the Reilly decision­benomyl, trifluralin, mancozeb, and phosmet. Sponsors of these pesticides sought and obtained stays in several cases. By the time the FQPA was passed, only three revocations were finalized: mancozeb on bran of wheat; propylene oxide on glace fruit, dried prunes, and starch; and simazine in potable water and sugar cane molasses.
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.
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.
Gary Lee, Food Safety Plan Approved by House Committee, WASH. POST, July 18, 1996, at A9; see also Rick Weiss, Clinton Signs New Standards on Food Safety, WASH. POST, Aug. 4, 1996, at A21 ("relieved to get rid of the Delaney Clause ...").
House Alters Pesticide Law, CHI. TRIB., July 18, 1996, at 1.
Senate Approves New Pesticide Rules, L.A. TIMES, July 25, 1996, at A6.
Michael Bronner, Congress Dumps Delaney, A New Age Dawns in Pesticide Regulation, NAT. FOODS MERCHANDISER, Sept. 1996, at 1.
Commerce Committee News Release, July 16, 1996, at 1.
... 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.
("If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that such drug induces cancer when ingested by man or animal ... he shall issue an order refusing to approve the application.").
Ch. 675, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§ 301-395).
Pub. L. No. 104-170, 110 Stat. 1489.
President Clinton signed H.R. 1627 into law on August 4, 1996. To his credit, his statement did not repeat the misinformation about the "repeal" of the Delaney Clause. White House Office of the Press Secretary, Statement by the President (Aug. 3, 1996).
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.
Regulation of Pesticides in Food: Addressing the Delaney Paradox Policy Statement, 53 Fed. Reg. 41104-10 (Oct. 19, 1988).
7 U.S.C. § 136, ELR STAT. FIFRA § 2.
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.
21 U.S.C. § 342(a)(2)(C); see supra note 16.
See Reilly, 968 F.2d at 989, http://www.elr.info/litigation/vol22/22.21303.cfm#21305 22 ELR at 21305 (emphasis added).
(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 FDA interpreted, and EPA cited as its Delaney approach (rejected by Judge Schroeder), the animal drug provisions, which allow a cancer-causing drug to be used in animal feed if there is no residue detectable by an agency-approved analytical method that permits a standard allowing detection by a method sensitive enough (sensitivity-of-method) to detect levels of residue representing a lifetime human cancer risk of more than one in one million. 44 Fed Reg. 17070 (Mar. 20, 1979). This FDA approach to animal feed regulation has yet to be tested in court.
Telephone Interview by Linda Bonvie with Michael Collins, Communications Director, Commerce Committee Press Office (July 1996) [hereinafter Collins Interview]. When Mike Collins, was asked why Commerce Committee press material refers to the Delaney Clause as having a "zero tolerance" for carcinogenic pesticide residues in processed foods, when the law allows such residues up to the tolerance in the raw agricultural commodity, he referred Bonvie to his legal counsel, who did not return Bonvie's telephone calls.
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.
Jennifer Ferrara, The Great Pesticide Compromise: How Many Deaths for a Dollar?, FOOD & WATER J., Fall 1996, at 12-14 (published by Food & Water, Walden, Vermont) [hereinafter The Great Pesticide Compromise]; Jennifer Ferrara, EVERYONE'S BACKYARD (Citizens Clearinghouse for Hazardous Waste 1996) [hereinafter EVERYONE'S BACKYARD]. Food & Water identified the following groups opposed to the H.R. 1627 compromise: National Coalition Against the Misuse of Pesticides, Washington, D.C.; Mothers and Others, New York City; Pesticide Watch, San Francisco, California; Washington Toxics Coalition, Seattle, Washington; Cancer Prevention Coalition, Chicago, Illinois; and The Environmental Research Foundation, Annapolis, Maryland. The article stated, "A loose coalition of Washington-based environmental research and lobbying organizations aligned themselves with corporate interest groups such as the American Crop Protection Association (ACPA), the Grocery Manufacturers Association, the Food Marketing Institute, all supporting the latest pesticide compromise signed into law this August. With the new law 'the produce industry can expect easier access to pesticides,' according to The Packer, a produce industry trade publication. At the same time the beltway groups offered their support for the compromise, the President of ACPA called the new law 'a particularly gratifying victory for us.'" The Great Pesticide Compromise, supra, at 12.
H.R. 3200, 104th Cong. (1996). Mike Collins during his interview with Linda Bonvie identified H.R. 3200 as the "real" bill "repealing" Delaney. Collins Interview, supra note 22.
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).
See id. § 107. This impression is especially reinforced under § 107, which is entitled "Improving the Delaney Clause."
FQPA, Pub. L. No. 104-170, 110 Stat. 1489.
Id. § 405, 110 Stat. at 1515-35 (codified as amended at 21 U.S.C. § 408).
Id. §§ 301-305, 110 Stat. at 1511-13.
The Great Pesticide Compromise, supra note 24; EVERYONE'S BACKYARD, supra note 24, at 28.
While this amount is higher than zero, the zero tolerance of the Delaney Clause never applied to pesticide residue in either raw agricultural commodities or processed foods. Environmental, consumer, and public interest group supporters of H.R. 1627 argue that the one cancer incidence per one million lifetimes is a stricter standard than the one used to set residue tolerances under the previous regulatory scheme.
7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-31.
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).
For a succinct summary of the Delaney history, see Bruce S. Wilson, The Legislative History of the Pesticide Residue Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958, in NAS REPORT, supra note 11; DONNA VOGT, U.S. FOOD ADDITIVE REGULATION: A CHRONOLOGY (Congressional Research Service, Science Policy Research Division, 95-875 SPR updated Sept. 13, 1995).
H.R. REP. NO. 82-2356, at 26 (1952), reprinted in 12 A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND ITS AMENDMENTS 524 (1979) [hereinafter LEGISLATIVE HISTORY].
Id. at 1, 4, reprinted in 12 LEGISLATIVE HISTORY, supra note 37, at 539, 542.
H.R. REP. NO. 82-2356, at 15, reprinted in 12 LEGISLATIVE HISTORY, supra note 37, at 787.
Id. at 6, reprinted in 12 LEGISLATIVE HISTORY, supra note 37, at 838.
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."
See 12 LEGISLATIVE HISTORY, supra note 37, at 349-510 (for food additive bills from the 83rd and 84th Congresses).
See Investigation of the Use of Chemicals in Foods and Cosmetics (1952), reprinted in H.R. REP. NO. 82-2356, at 12 (1952), reprinted in 12 LEGISLATIVE HISTORY, supra note 37, at 510; Food Additives: Hearings Before the Subcomm. on Health and Science of the House Comm. on Interstate and Foreign Commerce, 85th Congress, 1st Session, on Bills to Amend the Federal Food, Drug, and Cosmetic Act With Respect to Chemical Additives in Food 1 (1958), reprinted in 14 LEGISLATIVE HISTORY, supra note 37, at 169.
(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.
Wilson, supra note 36, in NAS REPORT, supra note 11, at 167 ("... the Secretary was defending the 'flow-through' provision as a measure 'inconsonant with a regulation now in force.'"); 14 LEGISLATIVE HISTORY, supra note 37, at 203 (materials submitted by M.B. Folsom, Secretary of HEW).
14 LEGISLATIVE HISTORY, supra note 37, at 615 (statement of William Goodrich, General Counsel of FDA).
Id. at 822, 845; H.R. REP. NO. 85-2284, at 24 (1958).
14 LEGISLATIVE HISTORY, supra note 37, at 869; 104 Cong. Rec. H17415 (daily ed. Aug. 13, 1958). Gloria Swanson told the author in 1970 that her speech to the Congressional Wives Club occurred during the two weeks in which the Administration changed its position. She felt the speech had been instrumental in the decision. Others corroborated her recollection. Additionally, the statement in her book that sets the speech in 1952 reads, "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." SWANSON, supra note 42, at 512 (emphasis added). The Delaney Amendment was voted on in 1958, not 1952. Delaney's statement (see supra note 42) is compatible with the 1958 date.
The word "loophole" is quoted by Bruce S. Wilson. See Wilson, supra note 36, in NAS REPORT, supra note 11, at 169.
Hearings on H.R. 7624 Before a Subcommittee on Interstate and Foreign Commerce, 86th Cong. 501 (1960).
34 Fed. Reg. 17063 (Oct. 21, 1969).
"The Delaney Clause 'zero-cancer-risk' provision has led to the cancellation of about eight different activities." VOGT, supra note 36.
Letter from Attorney General Griffin Bell to Secretaries of HEW and USDA (Mar. 30, 1979), reprinted in Secretary of Health, Education, and Welfare, and Secretary of Agriculture, Authority Under the Federal Food, Drug, and Cosmetic, Meat Inspection Act and Poultry Products Inspection Act, to Authorize the Continued Use of Nitrites as Food, Additives, 43 Op. Att'y Gen. 19 (1979); see Richard A. Merrill, FDA's Implementation of the Delaney Clause: Repudiation of Congressional Choice or Reasoned Adaptation to Scientific Progress, 5 YALE J. ON REG. 47 (1988).
Memorandum from John Harmon for the Attorney General Re: Proposed Phasing Out of Nitrites in Foods (Mar. 30, 1979), reprinted in 43 Op. Att'y Gen. 19 (1979). John Harmon, Assistant Attorney General, Office of Legal Counsel, and Griffin Bell are quoted in Merrill, supra note 54, which gives the most complete legal review of the application of the Delaney Clause through 1987. Nitrites remained on the market as a chemical that the FDA had specifically permitted in food before 1958 (prior sanctioned). 44 Fed. Reg. 75662 (Dec. 21, 1979) (codified at 21 C.F.R. § 170 (1987)).
<20173-74" target=_blankhttp://www.elr.info/litigation/vol18/18.20173.cfm#20173>20173-74 20173-74 (D.C. Cir. 1987).
Id. at 1108, http://www.elr.info/litigation/vol18/18.20173.cfm#20173 18 ELR at 20173.
NAS REPORT, supra note 11, at 1.
The following discussion is based on James S. Turner, The Delaney Anti-Cancer Clause: A Model Environmental Protection Law, 24 VAND. L. REV. 889 (1971).
Food and Drug Act of 1906, ch. 3915, 34 Stat. 768.
1933 FDA ANN. REP. 14.
Food, Drug, and Cosmetic Act of 1938, ch. 675, § 402(a), 52 Stat. 1040 (codified as amended at 21 U.S.C. § 342). Section 402(a) reads, "A food shall be deemed to be adulterated ... (2) if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of section 406 ...." Section 406(a) reads, "Any poisonous or deleterious 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 purposes of the application of clause (2) of section 402(a) ...." Id. § 406(a) (codified as amended at 21 U.S.C. § 346).
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).
"Under the law as it was [after 1938] the FDA could not stop the use of a chemical simply because it was questionable, or had not been adequately tested. It was necessary to be able to prove in court that the chemical was poisonous or deleterious." T. CHRISTOPHER, CASES AND MATERIALS ON FOOD AND DRUG LAW 468 (1966).
Webster's New International Dictionary (2d ed. 1957) defines "poisonous" as "having the properties or effects of poison"; i.e., "any agent which, introduced ... into an organism, may chemically produce an injurious or deadly effect." WEBSTER'S NEW INTERNATIONAL DICTIONARY (2d ed. 1957). It defines "deleterious" as "hurtful," "noxious; i.e., unwholesome." Id.
See Hearings on H.R. 74 Before the House Select Committee to Investigate the Use of Chemicals in Food Products, 81st Cong. (1951).
Act of July 22, 1954, ch. 559, 68 Stat. 511 (codified as amended at 21 U.S.C. § 346a).
Act of Sept. 6, 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified in scattered sections of 21 U.S.C.).
Act of July 12, 1960, Pub. L. No. 86-617, 74 Stat. 397 (codified in scattered sections of 21 U.S.C.).
21 C.F.R. § 120 (1971) (pesticides); Id. § 121 (1971)(food additives); Id. § 80 (1971) (color additives). In each case the process begins by the filing of a petition seeking a ruling by the Secretary that either allows the chemical to be used, or bars its use, in the ways sought by the petitioner. The decision of the Secretary comes in the form of an order that specifies the ways in which the chemical may be properly used. Detailed procedural rules govern the process that the Secretary and all interested parties must follow from the time the petition is filed until the time of a final order and dictate the way in which the appeals from the final order are to be brought to the attention of the courts.
One commentator described the Food Additives Amendment, and would probably say the same about the other two amendments, as "an example of law seeking to meet the problems that arise as side effects of scientific, economic and technological progress." CHRISTOPHER, supra note 64, at 130. Actually, it may be more accurate to say that these three amendments are examples of legislators seeking desperately to deal with the problems created by poor legislative drafting.
Food Additives Amendment of 1958, Pub. L. No. 85-929, § 4, 72 Stat. 1785 (codified as amended at 21 U.S.C. § 348(c)(3)(A)) (amending FFDCA § 409(c)(3)(A)).
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).
Food Additives, 35 Fed. Reg. 18623, 18624 (Dec. 8, 1970) (emphasis added).
[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)).
This is the regulatory procedure outlined above and is essentially the same for pesticide chemicals, food additives, and color additives.
"Safrole" is the ingredient used for flavoring in root beer.
Where the agency earlier had tried to choose which chemicals and which foods were safe, it now tried to choose which scientists were the best judges of safety. An FDA memorandum spelled out the guiding principle of the GRAS choice. "In our final evaluation of the safety of a substance we have taken cognizance of the fact that all opinions are not of equal value and thus have weighed most heavily the opinions of scientifically recognized and often world-renowned experts." Memorandum from the FDA Division of Pharmacology and Food (Sept. 2, 1959).
The details of this situation are spelled out in JAMES S. TURNER, THE CHEMICAL FEAST: THE RALPH NADER STUDY GROUP REPORT ON FOOD PROTECTION AND THE FOOD AND DRUG ADMINISTRATION 153-59, 162-63 (1970).
Hearings on H.R. 8112 Before a Subcommittee of the House Comm. on Interstate and Foreign Commerce, 85th Cong. 60 (1957-58) (remarks of FDA Commissioner George P. Larrick).
Food Additives, supra note 75, at 18623.
The GRAS list appears at 21 C.F.R. pts. 182, 184, and 186.
See How Safe Is Your Food?, U.S. NEWS & WORLD REP., Apr. 19, 1971, at 52.
Hearings on H.R. 7624 Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 86th Cong. 501 (1960). The members of the committee that reported to the Surgeon General on low levels of environmental carcinogens considered the arguments made by Secretary Flemming so important that they inserted the entire statement of the former Secretary into their report. Following the statement, they added this note: "The scientific basis on which the Government's position was established in 1960 remains valid. The progress of knowledge in the last decade has only strengthened the points made in Secretary Flemming's testimony." H.R. REP. No. 86-7624, at 38-105 (1960), reprinted in 16 LEGISLATIVE HISTORY, supra note 37, at 43-110.
EPA, Explanation of the Three Lists of Pesticides That Are Part of the Delaney Settlement Agreement Approved 2/8/94, EPA BACKGROUNDER, Feb. 1, 1995.
Sen. Richard Lugar, Policy Briefing, The Food Quality Protection Act Balances Food Safety With Agricultural Productivity and Updates the Delaney Clause (June 12, 1995).
American Farm Bureau Federation, Press Release (June 12, 1996).
EDITORS OF PESTICIDE AND TOXIC CHEMICAL NEWS AND FOOD CHEMICAL NEWS, THE DEMISES OF DELANEY, THE FOOD QUALITY PROTECTION ACT'S EFFECT ON PESTICIDE REGULATION 22 (CRC Press 1996).
FFDCA § 408(b)(1) (codified as amended at 21 U.S.C. § 346a(b)).
21 C.F.R. § 402(a)(2); 21 U.S.C. § 342(a).
EPA Notice of Receipt of Petition, 58 Fed. Reg. 29318 (May 19, 1993).
EPA Final Rule, Mancozeb on Raisins; Removal of Food Additive Regulation, 59 Fed. Reg. 33694 (June 30, 1994).
Telephone Interview by Linda Bonvie with Al Meyerhoff (Aug. 12, 1996) [hereinafter Meyerhoff Interview].
Id. at 1 (emphasis added).
53 Fed. Reg. 41104 (Oct. 19, 1988).
The pesticides were benomyl (grapes, raisins, tomatoes, puree, catsup), chlordimeform (plums, prunes), dichlorvos (figs; dried figs; nonperishable, bagged, packaged, processed food), dicofol (dried tea), mancozeb (barley, oats, rye, wheat, bran, flour), phosmet (cotton, cottonseed oil) trifluralin (peppermint, spearmint oil).
http://www.elr.info/litigation/vol22/22.21303.cfm#21306 21306 (9th Cir. 1992).
EPA Preliminary Response, 60 Fed. Reg. 31300 (June 14, 1995); EPA Final Response, 61 Fed. Reg. 2378 (Jan. 25, 1996).
The three lists are attached to this Article as Appendices I, II, and III.
See, e.g., EPA, FDA, USDA Press Statement (June 25, 1993); Testimony Before Joint Hearing of House Subcommittee on Health and Environment Committee on Energy and Commerce, and Senate Committee on Labor and Human Resources (Sept. 21, 1993).
NATIONAL RESEARCH COUNCIL, PESTICIDES IN THE DIETS OF INFANTS AND CHILDREN 12 (National Academy Press 1993).
NATIONAL RESEARCH COUNCIL, CARCINOGENS AND ANTI-CARCINOGENS IN THE HUMAN DIET 6 (National Academy Press 1996).
The amendment to § 408 modifies the safety standard, allowing a pesticide use outside the standard if "the use of pesticide that produces the residue protects consumers from adverse effects to health that pose a greater risk than the dietary risk from the residue, or the pesticide use avoids a significant disruption in domestic production of an adequate, wholesome, and economical food supply." See supra note 28. The committee cited aflatoxin as both an unsafe contaminant and a disrupter of the food supply that creates the possibility for the introduction of a pesticide safer than the substance it eliminates.
Commerce Committee, U.S. House of Representatives, News Release (July 16, 1996).
FQPA, Pub. L. No. 104-170, § 405, 110 Stat. 1489, 1532 (codified as amended at 21 U.S.C. § 346a(o)) (amending FFDCA § 408(o)).
COMMERCE COMMITTEE, U.S. HOUSE OF REPRESENTATIVES, LEGISLATIVE SUMMARY, H.R. 1627­THE FOOD QUALITY PROTECTION ACT OF 1996, SUMMARY OF MAJOR PROVISIONS (undated).
62 Fed. Reg. 2-12 (Aug. 4, 1997).
No. CIV 89-0752 (E.D. Cal. consent decree filed Dec. 2, 1994). In that case, California alleged "that EPA had failed to take certain actions to prevent residues of pesticides that 'induce cancer' from being present in processed foods as food additives contrary to the Delaney Clause." Consent Decree at 1, id.
Meyerhoff Interview, supra note 98.
ACADEMY FORUM, HOW SAFE IS SAFE? THE DESIGN OF POLICY ON DRUGS AND FOOD ADDITIVES 175-76 (National Academy Printing and Publishing Offices 1973) (this is the first in a series).

References: § 409
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 § 201
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 v. 
 § 408
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 § 408
 § 409
 § 409
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 § 409
 v. 
 § 136
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 § 321
 § 107
 § 107
 § 107
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 § 170
 § 402
 § 342
 § 406
 § 346
 § 346
 § 120
 § 121
 § 80
 § 4
 § 348
 § 409
 § 103
 § 376
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 § 346
 § 402
 § 342
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