APPENDIX A
Legal Aspects of the Food Additive Approval Process

Lars Noah*

[background paper commissioned by the Institute of Medicine of the National Academy of Sciences for a Food Forum workshop entitled Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies (1997)]

*  

Associate Professor, University of Florida College of Law. I would like to thank Douglas L. Archer, Marsha N. Cohen, Catherine L. Copp, Edward Dunkelberger, Margaret Gilhooley, Richard L. Hall, Peter Barton Hutt, Richard A. Merrill, Barbara A. Noah, George M. Paterson, George H. Pauli, Donna Porter, Sidney A. Shapiro, and Keith Triebwasser for reviewing earlier drafts of the manuscript, and Lisa M.W. Hillman for her research assistance. The views expressed in this paper do not necessarily reflect the opinions of any of the reviewers or the National Academy of Sciences. For a revised and updated treatment of this subject, see Lars Noah and Richard A. Merrill, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U.L. REV. 329 (1998).



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APPENDIX A Legal Aspects of the Food Additive Approval Process Lars Noah* [background paper commissioned by the Institute of Medicine of the National Academy of Sciences for a Food Forum workshop entitled Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies (1997)] *   Associate Professor, University of Florida College of Law. I would like to thank Douglas L. Archer, Marsha N. Cohen, Catherine L. Copp, Edward Dunkelberger, Margaret Gilhooley, Richard L. Hall, Peter Barton Hutt, Richard A. Merrill, Barbara A. Noah, George M. Paterson, George H. Pauli, Donna Porter, Sidney A. Shapiro, and Keith Triebwasser for reviewing earlier drafts of the manuscript, and Lisa M.W. Hillman for her research assistance. The views expressed in this paper do not necessarily reflect the opinions of any of the reviewers or the National Academy of Sciences. For a revised and updated treatment of this subject, see Lars Noah and Richard A. Merrill, Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U.L. REV. 329 (1998).

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Contents     History   15     The Food, Drug, and Cosmetic Act of 1938   16     The Food Additives Amendment of 1958   17     Definition of Food Additive   18     Components of Food   18     Indirect Additives   19     Dietary Supplements   20     Generally Recognized as Safe   22     Approval Procedures   27     Food Additive Petitions   27     GRAS Affirmation Petitions   30     Interim Food Additives   31     Safety Standards   32     General Safety Standard   32     Carcinogenicity and the Delaney Clause   34     Special Restrictions: Labeling   37     Case Studies   39     Artificial Sweeteners: Aspartame   39     Biotechnology: Calgene's Tomato   40     Novel Macroingredients: Olestra   43     The Composite Picture   45     Track Records Compared   45     A Catalogue of Proposed Solutions   47     Internal Management Initiatives   47     Statutory Hammers   48     Prioritizing Reviews   48     Imposing User Fees   49     Extramural Reviews   50     Combatting Sham Petitioning   52     Conclusion   53     Appendix: International Comparisons   54     Canada   54     The United Kingdom   55     The European Union   56     Japan   57     References   59

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What is food to one, is to others bitter poison. —Lucretius, De Rerum Natura (50 B.C.) In the past few years, novel food substances have attracted significant public attention, most notably Procter & Gamble's fat substitute olestra and Calgene's bioengineered tomato. Some have criticized the U.S. Food and Drug Administration (FDA) for its lengthy delays in reviewing these and other substances added to food.1 At the same time, others have argued that the agency does not adequately ensure the safety of such substances. These latest controversies pose significant and timely questions about how best to regulate substances added to food. The problems are multifaceted, and policymakers will require input from both legal and scientific perspectives to address them. This paper focuses primarily on a description of the FDA's regulation of substances intentionally added to food as it has evolved over the last several decades, and it concludes with a discussion of several possible avenues for reform. Debates about proposals to modify existing procedures must start with a proper appreciation of the difficulties encountered in the past. Moreover, the history of the food additive approval process illuminates significant and recurring challenges faced in the design of properly functioning regulatory programs. Studies of other federal agencies have uncovered valuable lessons about effective regulation that transcend the particular program under consideration.2 History The federal government first asserted authority over the quality and safety of food products early this century. In 1906, reacting to widely publicized examples of industry abuses, Congress prohibited the introduction of adulterated or misbranded food and drugs into interstate commerce.3 The act provided that any food containing an ''added poisonous or other added deleterious ingredient which may render such article injurious to health'' would be deemed adulterated. 4 If they detected a safety problem, federal officials could initiate enforcement action to remove the product from the market, but the government would shoulder the burden of proving that the ingredient posed "a reasonable possibility of injury."5 Although Congress replaced this original statute in 1938 with the federal Food, Drug, and Cosmetic (FD&C) Act,6 the newer legislation retained the same basic system of after-the-fact policing for adulterants in food until the Food Additives Amendment of 19587 created a premarket review and approval system. These two enactments are discussed more fully below. In the two decades that elapsed between the passage of the FD&C Act and the Food Additives Amendment, a number of developments rendered the original statutory design outdated. Indeed, the original legislation, based as it was on the 1906 Act, focused on the control of "adulterants" and did not fully anticipate the rapid progress in food processing technology and the growing utilization of intentional additives that would follow.8 Technological advances spurred by World War II allowed processors to offer more nutritious, palatable, and convenient foods, and consumers increasingly demanded such improved products. Meanwhile, progress in the biomedical sciences increased the understanding of human nutritional needs as well as chronic diseases. These pressures and advances have not yet abated, and, almost four decades later, one legitimately may ask whether Congress should consider once again updating (some would say overhauling) the statutory provisions governing food additives.9

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The Food, Drug, and Cosmetic Act of 1938 Under the original FD&C Act, the FDA enjoyed broad responsibility but fairly weak regulatory authority over substances added to food. Section 402(a) provided that a food shall be deemed to be adulterated under the following circumstances: (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)   if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of section 406 . . . 10 Section 406 of the Act provided in relevant part as follows: 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 [the above-quoted] clause; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health . . .11 The authority to promulgate food standards of identity under Section 401 provided the Agency with another, though cumbersome, regulatory mechanism for restricting the use of added substances by not authorizing their use as optional ingredients in standardized food.12 Under Section 402(a) of the FD&C Act, the FDA could initiate judicial proceedings to seize adulterated food or enjoin its continued marketing. 13 Unless the product exceeded one of the few tolerances established under Section 406, however, the agency would shoulder the burden of proving that the substance (1) was poisonous or deleterious and (2) may render the food injurious to health.14 As the Supreme Court held in construing the essentially identical language in the 1906 version of the statute,15 the government must show that the food containing a poisonous or deleterious substance creates a reasonable possibility of harm to consumers.16 Under the 1938 Act, the FDA shouldered an even greater burden of proof in the case of non-added substances (i.e., "ordinarily render it injurious to health").17 "Under either standard, the government must prove that the food itself probably will, or may, injure health, not merely that it contains a poisonous substance."18 Because of the time and effort required to undertake lifetime animal feeding studies of a substance, the FDA frequently could not satisfy this burden even if it had some legitimate basis for concern about safety.19 On the other hand, absent a tolerance established under Section 406, any added poisonous or deleterious substance would render a food adulterated,20 even if it was used at a level that was not "injurious" and served a useful purpose.21 In theory, Section 402(a)(2) reduced the FDA's burden of proof in taking enforcement action against a food product by eliminating any need for it to demonstrate that an added poisonous or deleterious substance might render the food injurious to health.22 The agency would still have to prove that an added substance was poisonous or deleterious. Once it made such a finding, however, the FDA would have difficulty authorizing the use of a safe and beneficial but technically "poisonous" substance in food. Thus, the original statute created a safety standard for substances added to food that was both unnecessarily rigid and quite difficult for the FDA to administer. Because it shouldered the burden of proof, the agency experienced problems in regulating the introduction and marketing of foods containing potentially hazardous substances. Moreover, because the statute did not

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require any advance notification of the introduction of a new additive for use in food, the agency might not even learn of its use unless safety problems subsequently came to light.23 Although the FDA initially lacked the authority to insist on testing, chemical manufacturers and food processors nonetheless had incentives to undertake limited safety evaluations. First, companies might fear eventual enforcement sanctions under the FDA's food adulteration provisions. Second, and more importantly, companies could not risk the adverse publicity that would accompany subsequently discovered hazards in their products. Finally, though less of an issue at the time, companies might face significant tort liability if consumers suffered injuries.24 In fact, most manufacturers did pretest new additives to some extent, but nothing prevented an unscrupulous firm from using an untested substance in food.25 The Food Additives Amendment of 1958 In 1950, Congress turned its attention to the growing use of chemical additives.26 After two years of hearings on the subject,27 a select committee of the House of Representatives chaired by James Delaney issued a report of its investigation. At the outset of its report, the committee noted the rapidly growing use of chemicals in the food supply: "There is hardly a food sold in the market place today which has not had some chemicals used on or in it at some stage in its production, processing, packaging, transportation, or storage."28 The committee recognized the substantial value of this growing use of additives, but it also expressed concerns about the accompanying potential health hazards.29 As noted in the report, the FDA estimated that approximately 700 chemicals were used in food at the time but that only 428 were known to be safe.30 The committee expressed particular concern over the lack of information about the possible chronic risks of existing food-use chemicals, and it urged Congress to amend the FD&C Act so that food additives would be governed by substantially the same safety and premarket review requirements applicable to drugs at that time.31 In the six-year period following the investigations by the Delaney Committee, Congress considered numerous bills and held further hearings on the subject.32 Unlike other legislative initiatives involving FDA-regulated products, which were prompted by real or perceived public health crises (most notably in the case of drugs), there was little apparent sense of urgency in crafting a proper response to the emerging concerns about new food additives. Instead, Congress acted with deliberation in designing an appropriate regulatory mechanism. 33 As an initial step, Congress amended the FD&C Act in 1954 to create a premarket approval system for pesticide residues in food, requiring the establishment of tolerances for any pesticide chemicals intended for use on a raw agricultural commodity.34 The food and chemical industries accepted the need for some system of premarket FDA review,35 but initially they preferred bills demanding little more than advance notification of an intent to market a new additive rather than bills requiring the issuance of a license by the agency.36 Administration officials objected that such an approach "would give no effect, except a delaying effect, to an adverse safety evaluation of the Secretary."37 Such a delay would give the FDA time to institute judicial proceedings to prevent marketing, where it only would have to establish that existing studies failed to demonstrate safety (rather than the more difficult burden of proving that an added substance was poisonous or deleterious and could render a food injurious to health); however, the agency would have to prove more than a reasonable possibility of harm in the abstract, under any condition of use; it would shoulder the more difficult burden of showing inadequate pretesting related to the safety of a substance for that particular intended use.

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In contrast, the Department of Health, Education, and Welfare (HEW), of which the FDA was a part, sponsored a bill that would prohibit the use of a new food additive unless and until the FDA promulgated a regulation specifically authorizing its use.38 The agency did not conceive of this proposal as a product-specific licensing scheme authorizing a particular use by the applicant, as is the case with new drug approvals, but rather as a limitation on a proposed use uniformly applicable to all persons.39 Under such a generic approval regime, the FDA would issue a nonexclusive public regulation authorizing the use of an additive by any person wishing to do so, subject only to any patent protection remaining for the food additive petitioner. Without any recorded discussion of the issue, Congress ultimately opted for the FDA's proposed approach. The bills also included various deadlines for FDA review of information about a new food additive. For instance, Congressman Delaney's original bill provided that a petition would be deemed approved if the Secretary failed to act on it within 60 days of filing.40 Under another bill, even if the Secretary concluded that an applicant had failed to demonstrate the safety of a new additive, a manufacturer or processor still could introduce the additive 30 days after notifying the agency of its intent to do so, unless the FDA first sought an injunction.41 The agency favored a premarket approval system but protested that it would need additional time to process submissions.42 In 1958, Congress enacted the Food Additives Amendment to the FD&C Act.43 By establishing a premarket review and approval system for food additives in new Section 409, Congress shifted the burden of proof on the safety issue from the FDA to the industry.44 Food additives now could not be used unless and until the agency deemed them safe. The legislation was not, however, motivated exclusively by safety concerns. Congress sought to promote continued innovation in food technology by giving the FDA greater flexibility to authorize limited uses of substances in food even if shown in animal tests to be poisonous at higher levels.45 The legislation also responded to proposals that had been introduced in a number of states to regulate new food additives. 46 The next three parts of this paper, focusing in turn on definitional, procedural, and substantive issues, set forth in greater detail the most important aspects of the Food Additives Amendment of 1958. Definition of Food Additive Definitional questions have assumed center stage in the application of the Food Additives Amendment over the last four decades. The statutory definition of the term "food additive" continues to pose significant interpretive difficulties. More importantly, as the food additive approval process has become increasingly cumbersome, industry has come to rely more heavily on certain exceptions enumerated in the definition. In fact, some of the recently suggested reforms focus on modifications of the existing definition in an effort to narrow the coverage of the Food Additives Amendment and, thereby, limit the scope of the FDA's premarket role. Components of Food The FD&C Act, as originally enacted, defined the term "food" as "articles used for food or drink .. [and] components of any such article."47 Putting aside the obvious tautology in the primary definition of the term, Congress clearly included "components'' of food within this provision.48 In addition, the operative provisions of the original statute—namely, the often vague prohibitions against adulteration and misbranding—refer to "substance[s]" which are added to food,49 as well as to "ingredients" from which a food has been fabricated. 50

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Although Congress never directly modified any of these early definitions, the Food Additives Amendment effectively displaced many of the statute's broad prohibitions against adulteration insofar as they affected substances added to food. 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 . . . , if such substance is not generally recognized . . . to be safe under the conditions of its intended use. . .51 By its terms, this definition does not include substances that are generally recognized as safe (GRAS), a potentially broad exception which, as discussed more fully in the next section, has become a central feature of the FDA's regulatory system. The definition enumerates a number of "indirect" additives included within its scope,52 but, as subsequently amended, it also specifically excludes several important substances that otherwise would be covered by the broad definition, including color additives, pesticide chemicals used on raw agricultural commodities, new animal drugs, and dietary supplement ingredients. 53 Other provisions of the statute now govern each of these latter substances.54 At its core, the definition of "food additive" applies whenever the manufacturer or food processor actually knew or should have known that a "substance" would become a "component or otherwise affect[ ] the characteristics of any food.'' The FDA routinely grapples with questions about the intended use of an item in order to determine its appropriate regulatory classification as, for instance, a food, drug, medical device, or cosmetic.55 Although Congress focused on "chemical" additives,56 items commonly available as a food might become a food additive (e.g., tomatoes in pasta sauce) unless otherwise excluded from the definition.57 Indirect Additives The definition of "food additive" clearly covers more than just intentional, functional additives; Congress expressly included substances which may indirectly become a component or otherwise affect the characteristics of food by virtue of their use in production or processing.58 Such "indirect" or "incidental"59 additives may, for instance, include chemical substances used in food-contact packaging which unavoidably, and often at barely detectable levels, migrate into the food.60 Before the FDA may regulate a substance as an indirect food additive, however, it must have some evidence that the substance may reasonably be expected to migrate into food.61 The agency then may impose conditions on the use of a substance to assure that it will not migrate into food. In the mid-1970s, the FDA grappled with evidence suggesting that acrylonitrile, a chemical used to fabricate plastic beverage bottles and other food-contact articles, might migrate into foods and might also cause cancer.62 After a formal hearing on the matter, the Commissioner decided that the acrylonitrile copolymer used to manufacture bottles qualified as a food additive whose safety remained unproven and, therefore, withdrew approval.63 The manufacturers immediately and successfully challenged this decision in court. In Monsanto Co. v. Kennedy,64 the United States Court of Appeals for the District of Columbia Circuit reversed the Commissioner's decision. According to the court, the FDA had adduced no concrete evidence to support its conclusion that some residual (unpolymerized) acrylonitrile monomer would migrate from the interior surface of the plastic container into the beverage.65 The court remanded the decision so that the Commissioner could consider migration data from recently improved detection methods and also decide, even if migration was probable at an extremely low level, whether to exercise his discretion to disregard any such migration as

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trivial.66 Relying on subsequently acquired migration data, the agency again concluded that acrylonitrile qualified as a food additive, but this time it also approved the additive as safe under conditions ensuring very little risk of migration.67 The FDA has approved innumerable indirect food additives over the years.68 In fact, the agency has devoted so much of its time and manpower to this task that it has, by comparison, seemingly neglected reviews of direct food additives.69 The FDA recently established an abbreviated exemption procedure for food-contact substances where the likelihood or extent of migration is so trivial—generally less than 0.5 parts per billion (ppb)-as not to require regulation.70 Except insofar as it affects the FDA's workload, the special questions posed by the regulation of indirect food additives are beyond the scope of this paper. Dietary Supplements One troubling question concerns how to differentiate between a food additive and the food itself. Before a recent amendment to the statute, this problem arose most frequently with regard to dietary supplements, but the interpretive issue is broader. Over the years, the agency has attempted to classify nutritional supplements as food additives (or drugs) so as to shift the burden of proof on questions of safety (and effectiveness) from the government to the industry. In a pair of recent cases involving black currant oil (BCO), two federal appellate courts rejected the FDA's position that BCO qualified as a food additive when sold in capsule form.71 In both instances, the agency had seized shipments of the dietary supplement on the theory that the BCO, as a component in the dietary supplement capsules, was presumptively unsafe.72 Notwithstanding the rule of judicial deference to reasonable agency interpretations of ambiguous language in an enabling statute, 73 neither court found the FDA's reading of the "food additive" definition persuasive.74 According to the courts in these cases, only those components that somehow modify a food may be regulated as food additives. In the case of the BCO capsules, the courts held that the black currant oil was the sole active ingredient and, therefore, properly regarded as the entire food rather than an additive in the food.75 Indeed, in litigating the seizure actions, the FDA had conceded that BCO sold in bottles containing the pure liquid form would not qualify as a food additive; the courts decided that replacing the bottle with a gelatin capsule as the delivery vehicle for the BCO should not affect its regulatory status.76 In the capsule form, two inert substances (gelatin and glycerin) encased the BCO. The dispute turned on the interpretation of the phrase "becoming a component or otherwise affecting the characteristics of any food," which the agency wished to read in the disjunctive (i.e., either becoming a component or affecting the characteristics . . . ), while the processors favored an overlapping, unitary interpretation (i.e., affecting the characteristics by becoming a component or otherwise . . . ).77 Although hardly unambiguous,78 both courts accepted the latter construction of the statute, observing that BCO did not appear to constitute a component in the first place,79 and explaining that BCO certainly did not affect the characteristic of the gelatin and glycerin.80 If the FDA's interpretation were valid, then the agency could recharacterize every processed food as a food additive in order to shift the burden of proving the food's safety onto the processor, in effect reading the 1938 provisions governing food out of the statute even though Congress chose not to amend them in 1958. This judicial gloss on the definition may, however, excessively narrow the class of food additives insofar as it suggests that the "component" must meaningfully affect the characteristics of the food; it is not clear, for instance, whether the gelatin and glycerin (or an equivalent plasticizer) in the BCO capsules would fall within these courts' interpretation of the definition of the term.81

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In earlier cases, courts have sustained efforts by the FDA to regulate similar products as food additives. Indeed, when a food contains more than one ingredient, each ingredient may be deemed a food additive, as the courts conceded in the BCO cases.82 For example, one federal district court accepted the FDA's contention that BCO was an additive when encapsulated with fish oil, vitamins, and minerals.83 Similarly, a federal appellate court recently decided that evening primrose oil was a food additive when encapsulated with Vitamin E.84 The difficult cases usually involved dietary supplements, in part because the FDA sought to find a meaningful regulatory mechanism for controlling these products. The agency also sometimes tried characterizing supplements as drugs rather than food.85 Indeed, the references to active and inactive ingredients make little sense in the context of conventional food products. To the extent that Congress has further restricted the agency's power to control the distribution of dietary supplements, these definitional issues may become less important in the future. Nonetheless, judicial interpretations of the statutory language will continue to limit the FDA's choice of regulatory responses to concerns about more conventional foods and food components. In 1994, Congress amended the FD&C Act to address dietary supplements, 86 and it has been suggested that food processors might utilize these special provisions to avoid the rigors of food additive review.87 If a substance can be classified as a "dietary supplement" or as an "ingredient" in such a supplement, then it is excluded from the definition of the term "food additive."88 Unless the substance represents a "new dietary ingredient'' (because it was not marketed before October 15, 1994),89 a manufacturer or processor would only have to file a premarket notification with the FDA 75 days prior to commercial use.90 The definition of the term "dietary supplement," which was added to the statute in 1994, has several elements. First, it is a product: intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any [of these] ingredients . . . 91 Second, it "is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form or, if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet."92 Third, the product must be labeled as a "dietary supplement."93 It is possible that the manufacturer of a conventional food (such as a candy bar) containing a new food—use substance (such as an artificial sweetener or a fat—substitute developed in the 1980s) might assert that the product (1) is intended to supplement the diet, (2) contains one or more of the enumerated dietary ingredients (even if the new food-use substance itself did not fit within any of those categories), (3) is labeled as a "dietary supplement," and (4) is not otherwise represented as a conventional food. It seems unlikely, however, that a company would take such a gamble in trying to circumvent the FDA's food additive approval requirements for new food-use substances added to conventional foods, nor is it clear that such an approach provides much of an advantage over using the existing GRAS exception.94 Indeed, simply labeling the product as a "dietary supplement" will not by itself counteract other indicia that a product containing a new food-use substance is being represented as a conventional food, though the agency may be more hesitant to pursue enforcement efforts in such a case.

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Generally Recognized as Safe The statutory definition of "food additive" covers only a substance that "is not generally recognized . . . to be safe under the conditions of its intended use."95 Thus, in the peculiar meaning of the term as it is used in the statute, a substance that becomes a component of a food (even as an ingredient) would not be a "food additive" if it is generally recognized as safe (GRAS). Congress further defined GRAS as requiring that a substance used in food be 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.96 Thus, GRAS status may exist if some level of scientific agreement about a substance's safety exists based either on appropriate testing or common use in food prior to 1958. The GRAS exception obviously raises a number of serious interpretive difficulties. The statute provides little further elaboration about the required degree of scientific agreement, the types of scientific procedures which could provide the necessary predicate for such agreement, or, in the case of substances in widespread use before 1958, the required nature and extent of such prior use. For instance, how could a substance be GRAS without experience based on common prior use—did Congress thereby intend to give manufacturers of new food-use substances the option of submitting test results to non-FDA scientists for their evaluation and possible stamp of approval? At least one witness at the 1957 congressional hearings apparently thought so, suggesting that a company could seek the advice of private or academic consultants on the question of whether there was general recognition of safety based on existing data.97 As discussed below, this has become a common practice. Because the GRAS exception became a common feature of every one of the numerous bills on the subject considered by Congress,98 the legislative history sheds some additional light on these and other questions. Although not technically a "grandfather clause" (which would permanently exempt from coverage all substances used in food prior to the enactment date),99 the GRAS exception attempts to minimize the potentially significant and unnecessary burden that would otherwise be placed on both the industry and the FDA if the agency had to evaluate and formally approve common substances used in food.100 In addition, for substances that were not regarded as GRAS and therefore subject to regulation as food additives, Congress initially provided a transitional period of up to 30 months for compliance with the new premarket approval requirements,101 but it subsequently extended this phase-in period by almost five additional years. 102 The FD&C Act included similar GRAS language in defining the term "new drug,"103 as did the Pesticide Residues Amendment of 1954.104 Although conceding during the congressional hearings that the language was inherently ambiguous, the agency thought that it could apply this flexible GRAS exception to food additives in a sensible manner. 105 (Interestingly, just two years after enacting the Food Additives Amendment, Congress failed to include a GRAS exception in the Color Additive Amendments.106) As subsequently construed by reviewing courts, the exception applicable to drugs is quite narrow,107 in part because the statute requires that a drug be both GRAS and GRAE (generally recognized as effective). In 1973, the Supreme Court held that the exception in the definition of new drug required an "expert consensus" of both safety and effectiveness.108 Both the FDA and reviewing courts sometimes have struggled to make sense of the GRAS exception109 All agree that there must be a fairly high level of scientific agreement.110 The

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FDA's implementing regulations, finally promulgated almost two decades after passage of the Food Additives Amendment, provide as follows: General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient. General recognition of safety through scientific procedures shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data and information.111 Evidence of GRAS must relate to the conditions of intended use; general recognition of the safe use of a substance in a different product or at a different level would not suffice to escape the food additive definition.112 The exception turns not on safety itself so much as on recognition of safety by scientific experts. Testimony of an absence of any evidence of a health hazard would not suffice to establish GRAS status,113 at least not unless coupled with evidence of common prior use.114 If GRAS status is premised on common use prior to 1958, then such use must have been fairly extensive.115 Originally, the FDA categorically refused to recognize use outside of the United States.116 This policy did not, however, survive a subsequent judicial challenge.117 The revised regulations provide that prior foreign use may support GRAS status, but only if the information about such use is readily available and corroborated.118 In addition, GRAS status based on prior foreign use must satisfy domestic conceptions of safety.119 If GRAS status is based on prior foreign use, the FDA urges the manufacturer to seek its concurrence.120 Other sections of the regulations continue to define eligibility for GRAS status by reference to common use in the United States.121 The FDA's GRAS Lists. During the congressional hearings leading up to enactment of the Food Additives Amendment, the FDA submitted a "partial" list of what it would regard as GRAS substances including items such as butter, coffee, cream, gelatin, lard, lemon juice, margarine, molasses, mustard, olive oil, paprika, pepper, salt, sugar, vinegar, and wine.122 During the first several years after enactment of the Food Additives Amendment, the FDA listed in its regulations hundreds of ingredients as GRAS.123 The original GRAS lists included, for example, ascorbic acid, calcium chloride, caramel, and sodium phosphate.124 Because these inventories emerged without any detailed scientific assessment of the original safety data, much less of the data subsequently generated with constantly improving detection and safety assessment methods (as underscored by the discovery of evidence linking an artificial sweetener mixture containing cyclamate to cancer125), the FDA initiated a systematic review in 1969 in order to settle the GRAS or food additive status of a number of substances commonly added to food.126 The agency designated several categories of food ingredients for this review: substances of natural biological origin which were widely consumed as food before 1958 but subsequently were modified in certain respects by new production processes or selective breeding; distillates, isolates, extracts, and reaction products of GRAS substances; and substances not of natural biological origin or intended for consumption for other than their nutrient properties.127 The National Academy of Sciences (NAS) undertook ingredient usage surveys,128 and, in 1972, the Life Sciences Research Office (LSRO) of the Federation of American Societies for Experimental Biology (FASEB) established a Select Committee on GRAS Substances (SCOGS) to conduct reviews of the available scientific literature.129 Over a period of 10 years, SCOGS forwarded to the FDA detailed reports on 468 food substances (of which 422 were direct ingredients).130 The Select Committee first created an array of five standardized recommendations,131 and it concluded that 72 percent of the food substances under review

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    torpor to jeopardize food research and innovation."); id. at 35 (statement of Sanford A. Miller, University of Texas Health Science Center) ("The agency's inability to reach decisions on their pending petitions has resulted in nearly a complete stasis in innovation in the food industry."); id. at 54 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America) ("The inherent delays resulting from this inability to make final decisions is beginning to turn off major food companies from investing in new additives and technology."); id. at 69 (statement of Rhona S. Applebaum, Executive Vice President, National Food Processors Association). 517.   See Douglas L. Archer & Catherine M. DeRoever, CFSAN's Program Offices, 48 FOOD & DRUG L.J. 487, 489 (1993) (describing the new Office of PreMarket Approval). The FDA also has proposed to coordinate with the USDA any reviews of substances intended for use in meat and poultry products. See 60 Fed. Reg. 67,490, 67,492 (1995). In addition, as part of the President's "Reinventing Government" initiative, the FDA published an advance notice of proposed rulemaking for its food additive regulations, though all of the suggested changes represent non-substantive revisions intended to eliminate redundancies or ambiguities in the rules governing specific additives. See 61 Fed. Reg. 29,711, 29,712-14 (1996). 518.   See 1995 Hearings, supra note 1, at 10-14 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA) (describing initiatives such as performance goals and outreach efforts to better educate petitioners about data requirements, and proposing to reduce environmental assessment requirements for routine petitions); see also Rulis, supra note 218, at 538-39; Administrative Reforms Could Significantly Reduce Petition Backlog, FOOD CHEM. NEWS, Feb. 26, 1996, at 3; FDA Food Ingredient Review Reform is Ongoing, With More Planned for the Future, FOOD CHEM. NEWS, Dec. 25, 1995, at 33; FDA Staff Manual Guide, Policies, Authority, and Procedures for Food and Color Additive Petitions and GRAS Affirmation Petitions (Apr. 1993). Many of these guidelines are available through CFSAN's home page, http://vm.cfsan.fda.gov/-dms/opa-toc.html. 519.   See 1995 Hearings, supra note 1, at 78 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council). 520.   See Rulis & Tarantino, supra note 215, at 141 (conceding that most "improvements in the efficiency of the process will take place at the margin, that is, improvements by factors of 10% to 20%"); OPA Contract Looks at Petition Review While Headway Seen on Backlog, FOOD CHEM. NEWS, Oct. 28, 1996, at 17 (reporting that the inventory of active petitions had been reduced from 295 in June 1995 to 240); see also 1995 Hearings, supra note 1, at 10-14 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA) (cautioning that "the zeal to speed up the process not be allowed to override the credibility and integrity of that process"); Hutt, supra note 1, at 128 (doubting that the FDA will "reform itself from within, and restore the efficiency and effective regulatory approach taken in the early 1960s"). 521.   See 1995 Hearings, supra note 1, at 72 (statement of Rhona S. Applebaum, Executive Vice President, National Food Processors Association) ("We have no reason to expect that new resolve by FDA to mend its ways, in response to current public concerns about its performance, will be sustained over the long term that is necessary for achievement of real action."); id. at 49 (testimony of Sanford A. Miller, University of Texas Health Science Center) ("I don't believe they are going to meet even their performance standards."); see also id. at 2 (statement of Hon. Christopher Shays, Subcommittee Chairman) (noting that, in the week preceding the hearings, the FDA finally acted on several GRAS affirmation petitions that had been pending since 1972). 522.   For petitions classified in Tiers I and II, the goal "is to issue an Agency response—that the submission is adequate, or provide a complete description of why it is not adequate—within" 90 and 180 days respectively. See 1995 Hearings, supra note 1, at 13 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA). Moreover, for most Tier III petitions, the announced goal is to provide such an initial response within 360 days, id., double the maximum statutory time frame for final action. See id. at 25-27 (statement of Hon. Christopher Shays, Subcommittee Chairman); see also Protecting the U.S. Consumer from Food-Borne Illnesses: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Reform and Oversight, 104th Cong., 2d Sess. (1996) (testimony of Michael Friedman, Deputy Commissioner for Operations, FDA) (announcing hopes to complete reviews on 50% of new direct food additive petitions within 12 months during the first year after the existing backlog is cleared). 523.   See S. 1477, 104th Cong., 2d Sess. § 103 (1996) (calling for a reduction in backlogs within two years and requiring the publication of annual reports of progress in satisfying the existing statutory deadlines). 524.   See H.R. REP. NO. 436, 104th Cong., 1st Sess. 14 (1995) (additional views of Hon. David M. McIntosh and Hon. Mark E. Souder) (concluding that the "inertia" within the FDA "cannot be eliminated without a significant enforcement hammer," and suggesting that the Agency be given a short period of time after a more realistic review period to either approve the additive or deny the petition if it "can demonstrate that an additive has not been found to be safe"); S. 1477,

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    104th Cong., 2d Sess. § 404 (743(c)) (1996) (providing that an additive already approved in the European Union or the United Kingdom would be deemed approved at the petitioner's request if the FDA fails to act on a petition within the statutory timeframe); 1995 Hearings, supra note 1, at 71, 83 (statement of Rhona S. Applebaum, Executive Vice President, National Food Processors Association) ("[W]ithout amendments to the Act that establish an effective forcing mechanism, there can be no real prospect for substantial improvement in the food additive approval process."); id. at 87 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America). 525.   See, e.g., H.R. 2245, 83d Cong., 1st Sess. § 6 (407(d)) (1953). 526.   See, e.g., Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, §§ 2(b), 3(b), 104 Stat. 2356, 2360; Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 3(c)(2), 104 Stat. 4511; Hazardous and Solid Waste Amendments of 1984, Pub. L. No. 98-616, § 201, 98 Stat. 3226 (codified at 42 U.S.C. § 6924(c) (1994)); see also M. Elizabeth Magill, Congressional Control Over Agency Rulemaking : The Nutrition Labeling and Education Act's Hammer Provisions, 50 FOOD & DRUGL.J. 149 (1995). 527.   See 1995 Hearings, supra note 1, at 177 (statement of Michael F. Jacobson, Executive Director, CSPI) ("[I]ndustry should realize that a rigid time limit for the review process could well mean that the FDA would simply reject a petition that currently would be put in abeyance pending further research and analysis."); Hutt, supra note 1, at 128 ("[I]t is all too easy for FDA simply to issue continual denials . . . on the ground that further testing is needed."); see also 43 Fed. Reg. 27,507, 27,509 (1978) (ACUS recommendation against the imposition of strict deadlines); Alden F. Abbott, The Case Against Federal Statutory and Judicial Deadlines: A Cost-Benefit Appraisal, 39 ADMIN. L. REV. 171 (1987). 528.   See, e.g., Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 654 (1973) ("Threshold questions within the peculiar expertise of an administrative agency are appropriately routed to the agency, while the court stays its hand."); Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1376 (9th Cir. 1983). Thus, unsuccessful applicants rarely prevail on judicial review and, therefore, frequently do not even bother appealing from an unfavorable Agency decision. See HUTT & MERRILL, supra note 170, at 533-34 (canvassing case law involving FDA denials of applications for new drug approval). 529.   See H.R. REP. No. 436, 104th Cong., 1st Sess. 8 (1995) ("The leveling of FDA resources for foods in recent years is in sharp contrast with the increased responsibilities CFSAN has assumed due to new legislation . . . ."); 1995 Hearings, supra note 1, at 35-36 (statement of Sanford A. Miller, University of Texas Health Science Center) (noting that CFSAN is "under funded and overly-committed" but that "it is highly improbable" that it could get the 200-300 extra reviewers it needs for food additives); id. at 54 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America); cf. id. at 53 (Reduced resources are "more of a symptom and not a root cause" of the breakdown in the food additive approval process. ''The fundamental causes are lack of a clear mission, a steady decline in priority over the years, and the increasing lack of incentive and ability of the agency to make a final positive decision on a petition against the statutory criteria.''). 530.   See 60 Fed. Reg. 36,582 (1995); see also Jerome H. Heckman, Closing in on Zero, 45 FOOD DRUG COSM. L.J. 599 (1990) (discussing long-running industry efforts at trying to convince the FDA to adopt a threshold of regulation policy); Alan M. Rulis et al., FDA's Priority-Based Assessment of Food Additives, 4 REG. TOXICOL. & PHARMACOL. 37 (1984). 531.   See Rulis & Tarantino, supra note 215, at 141 (noting that this "could free up a considerable amount of person power for work on petitions of greater consequence to the food supply and public health protection"); 1995 Hearings, supra note 1, at 64 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America) ("Under the proposed process for indirects, a notification would be submitted to FDA . . . and take effect in ninety days and use of the substance therefore allowed, unless FDA concluded that there existed substantial evidence to show" migration or lack of safety). 532.   See 21 C.F.R. § 170.39 (1996). The threshold is set at a concentration of 0.5 ppb or, in the case of an approved direct food additive being used in a food-contact material, at 1% of the ADI. Id. § 170.39(a)(2). The substance may not be exempted (much less approved) if it has been shown to induce cancer. Id. § 170.39(a)(1). The 0.5 ppb threshold attempts to ensure an upper-bound lifetime risk of cancer of less than one-in-one million in the event that a substance later proves to be carcinogenic. See 60 Fed. Reg. at 36,583. The Agency rejected a suggestion that it extend the policy to substances added directly to foods at low levels. Id. at 36,585. 533.   See 60 Fed. Reg. at 36,589-60 (observing that "such reviews can usually be completed within 3 to 4 months," but fearing that a formal deadline would restrict the Agency's flexibility in allocating resources among competing priorities); cf. S. 1477, 104th Cong., 2d Sess. § 802(a) (1996) (proposing to force the FDA to act on premarket notifications for indirect additives within 90 days); S. REP. NO. 284, 104th Cong., 2d Sess. 62 (1996) ("This simple procedure will allow the FDA to quickly dispose of its existing inventory" of indirect food additive petitions.); Kessler Objects to Hammer Provisions, Shorter Review Times at Senate Hearing, FOOD CHEM. NEWS, Feb. 26, 1996, at 25.

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534.   See 1995 Hearings, supra note 1, at 133-41 (statement of Jerome H. Heckman, on behalf of the Society of the Plastics Industry) (explaining that exemption petitions under the threshold of regulation policy already have become backlogged at about six months, and proposing a substantially less formal procedure for reviewing indirect food additives); Hutt, supra note 1, at 122 (supporting the threshold of regulation concept but criticizing the replacement of food additive petitions with exemption petitions). 535.   See 60 Fed. Reg. at 36,586-87, 36,589 (rejecting suggestions that companies be permitted to make their own judgment that a substance is exempt under the threshold of regulation policy, though noting that companies remain free to decide that a substance is not a "food additive" to begin with because it is not likely to migrate). Once the FDA issues a letter granting an exemption, any company wishing to utilize the substance under the same conditions of use may rely on the exemption. See id. at 36,587, 36,591-92. 536.   See Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, § 8, 108 Stat. 4331 (codified at 21 U.S.C. § 350b(a)(2) (1994)); supra note 6. 537.   See S. REP. NO. 513, 101st Cong., 2d Sess. 15 (1990) ("Over 95% of the devices marketed since the passage of the [1976] Amendments have been found 'substantially equivalent' to a predicate device."); GAO, MEDICAL DEVICES: FDA REVIEW TIME, No. PEMD-96-2 (1995); Robert B. Leflar, Public Accountability and Medical Device Regulation, 2 HARV. J.L. & TECH. 1 (1989) (arguing that Section 510(k) has been used inappropriately to circumvent full approval requirements); Lawrence S. Makow, Note, Medical Device Review at the Food and Drug Administration: Lessons from Magnetic Resonance Spectroscopy and Biliary Lithotripsy, 46 STAN. L. REV. 709 (1994). To address growing backlogs, the Agency recently exempted numerous classes of low-risk devices from the notification requirement. See 59 Fed. Reg. 63,005 (1994). 538.   See 1995 Hearings, supra note 1, at 79 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council); cf. id. at 13 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA) (suggesting that most such petitions would fall within Tier I, for which the performance goal time frames are just 90 days for an initial response); 48 Fed. Reg. 48,457, 48,458 (1983) (explaining that GRAS self-determination would be possible for an additional use of a substance affirmed as GRAS but not for one approved as a food additive). 539.   See H.R. REP. No. 436, 104th Cong., 1st Sess. 8 (1995) (noting that the FDA "utiliz[es] a 'first in, first out' review system which does not devote the greatest resources to the applications with the greatest resource requirements"); 1995 Hearings, supra note 1, at 12, 19 (statement and testimony of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA) ("We need to get rid of the backlog so that we can start fresh in this program."). 540.   See supra notes 310-13 and accompanying text. 541.   See GAO, NEW FOOD TECHNOLOGIES, supra note 9, at 63-64 (noting that the Edwards Committee "concluded that FDA must recognize that approving useful and safe new products can contribute as much to public health as preventing the marketing of harmful or ineffective products," adding that some "have proposed that FDA establish a fast track for processing petitions for food additives that provide some positive public health benefit"); The Need for FDA Reform: Hearing Before the Subcomm. on Health and Environment of the House Comm. on Commerce, 104th Cong., 2d Sess. 100 (1996) (statement of Michael W. Pariza, Director of the Food Research Inst.); 1995 Hearings, supra note 1, at 104-05 (testimony of Michael H. Davidson, Medical Director, Chicago Center for Clinical Research) (describing potential benefits of fat substitutes, and recommending that ''at least priority be given to those food additives that do have health benefits, that they receive expedited approvals, or reviews"). 542.   See 21 C.F.R. pt. 314(h) (1996) (establishing expedited approval procedures for new drugs indicated for the treatment of serious or life-threatening illnesses); HUTT & MERRILL, supra note 170, at 529-31 (describing previous system for prioritizing new drug reviews according to therapeutic potential). 543.   See 1995 Hearings, supra note 1, at 13 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA). 544.   See GAO, NEW FOOD TECHNOLOGIES, supra note 9, at 89-95. 545.   See Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, tit. I, 106 Stat. 4491 (codified at 21 U.S.C. § 379h (1994)); Bruce N. Kuhlik, Industry Funding of Improvements in the FDA's New Drug Approval Process: The Prescription Drug User Fee Act of 1992, 47 FOOD & DRUG L.J. 483 (1992). 546.   See 1956 Hearings, supra note 19, at 141 (HEW memorandum) ("We cannot absorb this important new function without serious neglect of other essential responsibilities. And the cost of obtaining governmental review of scientific data to assure safety of a new chemical is a legitimate charge to the cost of doing business."). Industry representatives expressed

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    strong opposition to the request for such authority. See, e.g., id . at 95 (statement of Glenn G. Paxton, appearing as counsel for various food industry associations). 547.   See Pub. L. No. 83-518, § 3 (408(o)), 68 Stat. 517 (codified at 21 U.S.C. § 346a(o) (1994), as repealed and replaced by the Food Quality Protection Act of 1996, Pub. L. No. 104-170, § 405 (408(m)), 110 Stat. 1529). 548.   See, e.g., H.R. 4014, 85th Cong., 1st Sess. § 6 (1957); see also 104 CONG. REC. 17,424 (1958) (statement of Hon. Leonor K. Sullivan) (calling for adequate appropriations so that the FDA could execute its significant new responsibilities in reviewing food additives). An early draft of Congressman Dingell's recent bill, H.R. 5952, 102d Cong., 2d Sess. (1992), had included provisions applicable to food additive but not GRAS affirmation petitions, establishing an interim annual user fee of $75,000. (Although a one time filing fee might make sense, an annual fee imposed after approval would unfairly tax the petitioner, and a fee imposed only during the pendency of the FDA's review might create a perverse incentive to delay approval.) 549.   See National Cable Television Ass'n v. United States, 415 U.S. 336, 340-341 (1974); see also Skinner v. MidAmerica Pipeline Co., 490 U.S. 212, 223 (1989); Clayton P. Gillette & Thomas D. Hopkins, Federal User Fees: A Legal and Economic Analysis, 67 B.U. L. REV. 795, 826-45 (1987). 550.   See supra notes 231-35 and accompanying text. 551.   See 1995 Hearings, supra note 1, at 29 (testimony of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA) ("[A] user fee program is difficult in the food additive area because a manufacturer is not given a product license as one is in the drug and devices area."); id. at 170 (testimony of Stuart M. Pape, on behalf of the National Soft Drink Association); cf id. at 141 (statement of Jerome H. Heckman, on behalf of the Society of the Plastics Industry) (noting that "modest filing fees could be charged for [proposed indirect food additive premarket] notifications since they would be basically proprietary"); id. at 169. In fact, based on conversations held after the conclusion of the hearings, it appears that the FDA ''may propose user fees to fund pre-filing consultation activities with sponsors." H.R. REP. No. 436, 104th Cong., 1st Sess. 3 (1995). 552.   See 1995 Hearings, supra note 1, at 186 (statement of Keith C. Triebwasser, Procter & Gamble) ("Patents alone do not provide this security, since patents are difficult to obtain in the food industry and difficult to enforce. Margins in the food industry are too low to support protracted patent battles."); Hutt, supra note 1, at 126 ("Without a statutory period of market exclusivity, American industry cannot be expected to invest in new food additives that cannot be patented, even if the regulatory process itself is reformed."). 553.   See Elizabeth C. Price, Teaching the Elephant to Dance: Privatizing the FDA Review Process, 51 FOOD & DRUG L.J. 651 (1996); Charles J. Walsh & Alissa Pyrich, Rationalizing the Regulation of Prescription Drugs and Medical Devices: Perspectives on Private Certification and Tort Reform, 48 RUTGERS L. REV. 883, 987-1016 (1996). See generally Ronald A. Cass, Privatization: Politics, Law, and Theory, 71 MARQ. L. REV. 449 (1988); Harold J. Krent, Fragmenting the Unitary Executive: Congressional Delegations of Administrative Authority Outside the Federal Government, 85 Nw. U. L. REV. 62 (1990); Douglas C. Michael, Federal Agency Use of Audited Self-Regulation as a Regulatory Technique, 47 ADMIN. L. REV. 171 (1995). 554.   See supra notes 128-33 and accompanying text. 555.   See 1995 Hearings, supra note 1, at 12 (statement of Linda A. Suydam, Interim Deputy Commissioner for Operations, FDA). The FDA also has initiated a limited pilot program allowing third-party reviews of premarket notifications for certain medical devices. See 61 Fed. Reg. 14,789 (1996). The EPA makes use of extramural reviews for pesticide data submissions. See 7 U.S.C. § 136w(d) (1994); 40 C.F.R. § 155.27 (1996). 556.   See, e.g., 1995 Hearings, supra note 1, at 116-17, 171 (statement and testimony of Kenneth D. Fisher, Former Director of LSRO, FASEB); id. at 44-45 (statement of Richard L. Hall, Chairman, NAS Food Forum); id. at 54-55, 62-67 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America); see also id. at 36 (statement of Sanford A. Miller, University of Texas Health Science Center) (explaining that extramural reviews could provide a method of leveraging the Agency's limited resources, but emphasizing that the FDA cannot abdicate its regulatory duties and must, therefore, closely supervise external reviews); Stuart M. Pape, Food Industry Initiatives to Improve the FDA's Food Ingredient Review Processes, 51 FOOD & DRUG L.J. 413, 417-20 (1996). 557.   See 5 U.S.C. app. 2 (1994); 21 C.F.R. pt. 14 (1996); Food Chem. News v. Young, 709 F. Supp. 5, 6-9 (D.D.C. 1989) (holding that a FASEB expert panel under contract to prepare a food safety report for the FDA was subject to the provisions of the Federal Advisory Committee Act, including requirements for balanced membership and open meetings), rev'd, 900 F.2d 328 (D.C. Cir.), cert. denied, 498 U.S. 846 (1990); see also Animal Legal Defense Fund, Inc. v. Shalala,

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    1997 U.S. App. LEXIS 353 (D.C. Cir. Jan. 10, 1997) (holding that FACA applied to NAS guidance concerning the care of laboratory animals); Washington Legal Found. v. United States Sentencing Comm'n, 17 F.3d 1446 (D.C. Cir. 1994); Steven P. Croley, Practical Guidance on the Applicability of the Federal Advisory Committee Act, 10 ADMIN. L.J. 111 (1996). 558.   See 1995 Hearings, supra note 1, at 84 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America) ("[T]he check can surely go through FDA's hands, provided a service charge is not excised during the process."). 559.   See H.R. REP. NO. 436, 104th Cong., 1st Sess. 10, 12 (1995) (recommending this approach); H.R. 3200, 104th Cong., 2d Sess. § 105(c)(3) (1996); 1995 Hearings, supra note 1, at 36 (statement of Sanford A. Miller, University of Texas Health Science Center) ("If for example FDA does not issue a regulation or a report defending an opposing view within the prescribed time, then an assumption of approval is made."); id. at 63 (statement of Stephen A. Ziller, Vice President, Grocery Manufacturers of America) ("The presumption of approvability arising from a favorable report of the independent review organization would be rebuttable by FDA only if it concluded that there existed substantial evidence to demonstrate that the additive had not been shown to be safe."); Hutt, supra note 1, at 128 (''FDA would not be permitted, in its review of that recommendation, to veto marketing of the product on the ground that it still needs further testing."). 560.   See Degnan, supra note 98, at 580-82. The GRAS concept provides the agency with a mechanism for concentrating its resources in these [novel food] areas—and for shifting some of its traditional food additive type functions away from substances which do not raise safety issues that only the agency is qualified to address. As a result, the general pace of decision-making could quicken because the scientific and technical staffs available for the review of safety issues would be subject to less diversions and able to concentrate on matters of high priority. Id. at 582; see also 1995 Hearings, supra note 1, at 170 (testimony of Kenneth D. Fisher, Former Director of LSRO, FASEB) (observing that the FDA "has made the GRAS affirmation process analogous to the food additive petition process," and applauding the Agency's recent suggestion "to separate these and make the GRAS affirmation process perhaps what it was originally meant to be: a way to separate food additives and GRAS substances"). 561.   See supra notes 128-33 and accompanying text. 562.   See 1995 Hearings, supra note 1, at 80 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council). 563.   See 62 Fed. Reg. 18, 938, 18,941 (1997) ("This streamlining would allow FDA to redirect its resources to questions about GRAS status that are a priority with respect to public health protection . . . [and] to its statutorily mandated task of reviewing food and color additive petitions."). 564.   See supra Part II.B.2. 565.   Cf. Heckman, supra note 60, at 49 ("A food packaging manufacturer often files a food additive petition because he would rather be safe than sorry. But by the time he emerges from the petition ordeal, he will certainly be sorry and may not be one whit more safe."). 566.   See 21 C.F.R. § 180.1(c)(3) (1996) ("[I]f the Commissioner concludes that the studies are not being pursued promptly and diligently or if interim results indicate a reasonable likelihood that a health hazard exists, an order will promptly be published in the FEDERAL REGISTER revoking the interim food additive regulation effective on publication."). 567.   See Degnan, supra note 98, at 567 ("Because FEMA's GRAS determinations are independent, they do not bind the FDA. It is standard practice, however, for food processors to rely upon FEMA's GRAS determinations. The FDA has deferred to FEMA's practice and has only rarely taken issue with a FEMA determination."). 568.   See id. ("While FEMA's far-reaching GRAS review might seem a challenge to the FDA's authority and to the principle of premarket approval, the group's scientific and professional approach to making thorough GRAS determinations actually has provided important assistance to the FDA in its efforts to implement the [Food Additives Amendment] efficiently."). 569.   Cf. Lars Noah & Barbara A. Noah, Liberating Commercial Speech : Product Labeling Controls and the First Amendment, 47 FLA. L. REV. 63, 72 & 107-11 (1995) (discussing the FDA's guidelines for industry sponsorship of continuing medical education programs).

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570.   See 1995 Hearings, supra note 1, at 89 (testimony of Stephen A. Ziller, Vice President, Grocery Manufacturers of America) ("I think the people who don't want additives, virtually of any type, any way, will see this as moving decisions away from a group that they think they have greater political power over."); id. at 177-79, 184-85 (statement of Michael F. Jacobson, Executive Director, CSPI) (doubting that third party reviews would reduce delays substantially, fearing "conflicts of interest among reviewers and forum shopping by additive manufacturers," and concluding that "safety evaluations should be made by FDA officials, who are publicly accountable, not by outsiders"). 571.   See id. at 88 (statement of Hon. Edolphus Towns). 572.   See id. at 124 (statement of Stuart M. Pape, on behalf of the National Soft Drink Association) ("Contrary to some suggestions, this is not a radical reversal of the burden [of] proving that the additive is safe . . . [but the] FDA should not be able to frustrate the purpose of independent review and prevent the approval of the additive merely by identifying some question or issue that is unresolved."); id. at 168 ("The proposal we made would require FDA to have substantial evidence, not to demonstrate that the additive is unsafe, but simply substantial evidence to demonstrate that safety hasn't been shown."). 573.   Lars Noah, Sham Petitioning as a Threat to the Integrity of the Regulatory Process, 74 N.C. L. REV. 1 (1995). 574.   Id. at3. 575.   See 21 C.F.R. § 171.1(h) (1996). Certain confidential information and protected trade secrets are exempt. See, e.g., id. §§ 171.1(h)(l)(iii) (exempting from public disclosure identifying information in adverse reaction reports and consumer complaints), 171.1(h)(2) (exempting from public disclosure manufacturing methods, sales data and quantitative formulas). 576.   See supra notes 207-13 and accompanying text. 577.   52 Fed. Reg. 17,475 (1987); see also 51 Fed. Reg. 34,503 (1986) (notice of filing of a food additive petition for alitame, another sweetener that the FDA continues to review ten years later). 578.   See Formal Comment Period on Food Additive Petitions Requested, FOOD CHEM. NEWS, July 6, 1992, at 36-37 (suggesting that the tardy submission by the Center for Science in the Public Interest of old data about sucralose, data which purportedly was received from an anonymous source, may have reflected bad faith intervention by a company seeking to retain its competitive advantage in the market for non-nutritive sweeteners). But see 1995 Hearings, supra note 1, at 181 (statement of Michael F. Jacobson, Executive Director of CSPI) (responding that CSPI "has not been used by anti-competitive forces to delay decisions on pending petitions"). 579.   See H.R. REP. NO. 436, 104th Cong., 1st Sess. 5 (1995); see also Ron Wasik, A Sweet New Alternative, FOOD IN CANADA, June 1991, at 27 (describing review of the sucralose petition in Canada). 580.   See FDA Delay in Sucralose Approval Gets "Golden Grinch " Award from Sen. Mathews, FOOD CHEM. NEWS, Aug. 29, 1994, at 46 (quoting Sen. Harlan Mathews as complaining that "'any third party could indefinitely delay approval of [a food] additive simply by repeatedly submitting their interpretation of data'"); see also 1995 Hearings, supra note 1, at 78 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council) (noting that "the careful timing of their submissions can hold up a review numerous times just short of approval"); id. at 90-91 (describing anonymous submissions as a method of delaying FDA approval of a food additive petition for competitive reasons); House Patent Extension Hearing, supra note 438, at 186, 204, 383 (statement of Edwin L. Artzt, Chairman and CEO of the Procter & Gamble Co.) (suggesting that Unilever, a competitor developing an additive like olestra, "funded a group of scientists who wrote to the FDA, urging caution and more testing'' on Procter & Gamble's pending petition). 581.   See Letter from George H. Pauli, Ph.D., CFSAN's Office of Premarket Approval, to Sandra Schlicker, Ph.D., Director of the NAS's Food Forum, Sept. 27, 1996, at 7 (copy on file with the author) ("All outstanding issues still have not been resolved, and it is misleading to attribute to comments a delay in reaching a decision based on the original data. Comments that have little merit will not cause lengthy delays."). 582.   See H.R. REP. NO. 436, 104th Cong., 1st Sess. 9 (1995); see also id. at 12-13 ("Manipulation of the food additive review process for anti-competitive purposes is inconsistent with the purposes of premarket review."). 583.   See Cutler v. Hayes, 818 F.2d 879, 896-97 (D.C. Cir. 1987) ("[E]xcessive delay saps the public confidence in an agency's ability to discharge its responsibilities and creates uncertainty for the parties, who must incorporate the potential effect of possible agency decision-making into future plans." (internal quotation marks omitted)); Noah, supra note 573, at 58 ("[T]he largely unrestricted opportunity to participate brings with it the possibility for strategic manipulation of the regulatory process in pursuit of anticompetitive ends.").

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584.   See In re International Chemical Workers Union, 958 F.2d 1144 (D.C. Cir. 1992) (issuing a writ of mandamus after a six year delay by OSHA); Public Citizen Health Research Group v. Commissioner, 740 F.2d 21, 32 (D.C. Cir. 1984) ("[C]ourts are certainly not without power to address the interests of a regulatory beneficiary . . . when unwarranted agency delay prejudices those interests."); Nader v. FCC, 520 F.2d 182, 206 (D.C. Cir. 1975) ("There comes a point when relegating issues to proceedings that go on without conclusion in any kind of reasonable time frame is tantamount to refusing to address the issues at all—and the result is a denial of justice."). 585.   Abbott Laboratories v. Harris, 481 F. Supp. 74, 76 (N.D. Ill. 1979) ("It is undisputed that the administrative process has gone on for six years without an order from which plaintiff could seek judicial review."). 586.   Southeastern Minerals, Inc. v. Califano, Civ. No. 77-51-THOM (M.D. Ga. Jan. 31, 1978). Counsel for the government in that case admitted that the FDA's delay in responding to the petition was "outrageous" and "unjustified;" the Agency "wisely decided not to appeal from that portion of the district court's judgment." Southeastern Minerals, Inc. v. Harris, 622 F.2d 758, 768 (5th Cir. 1980). The court of appeals in that case noted that the "FDA's disregard for the statutory and regulatory requirement that the agency act on a pending petition within a maximum of 180 days is equally regrettable and inexcusable." Id. at 767; see also In re Center for Auto Safety, 793 F.2d 1346, 1353-54 & n.55 (D.C. Cir. 1986). 587.   See 21 U.S.C. § 348(c)(2) (1994); 21 C.F.R. § 171.100 (1996). 588.   Sierra Club v. Costle, 657 F.2d 298, 397 (D.C. Cir. 1981) ("Most likely the drafters [of the Clean Air Act Amendments] envisioned promulgation of a rule soon after the close of the public comment period, and did not envision a months-long hiatus where continued outside communications with the agency would continue unabated."). [Interested parties] cannot force an agency to delay rulemaking simply because some new rebuttal evidence may be forthcoming; this is particularly so when the statute mandates speedy promulgation of the rule. Were it otherwise, participants could delay promulgation indefinitely since new information continually comes to light on the subject of many proposed rules. Id. at 399-400; see also Community Nutrition Inst. v. Block, 749 F.2d 50, 58 (D.C. Cir. 1984) ("Rulemaking proceedings would never end if an agency's response to comments must always be made the subject of additional comments."). 589.   60 Fed. Reg. 57,586, 57,587 (1995). 590.   See 21 C.F.R. § 330.10(a)(6) (1996); 45 Fed. Reg. 31,422, 31,424 (1980) ("[T]he agency's decision in a tentative final monograph will be based solely on the administrative record developed through the 90-day comment and 30-day rebuttal comment period."). The FDA requires that petitions for reconsideration be filed within 30 days of a decision, 21 C.F.R. § 10.33(b), "in order to make certain that such matters are settled promptly. Although filing such petitions would not operate to delay any administrative action, the uncertainty that would be generated by permitting such petitions at any point in time would undermine effective implementation of the act." 40 Fed. Reg. 40,682,40,687 (1975). 591.   See Cutler v. Kennedy, 475 F. Supp. 838, 854 (D.D.C. 1979) (deciding that the FDA's regulation of OTC drugs, by "formally authoriz[ing] the continued marketing of Category III drug products in the absence of an administrative determination that those products are" GRAS/GRAE, "flies in the face of statutory scheme"). Indeed, the FDA considers a food additive petition automatically withdrawn if the petitioner fails to submit, in response to a timely request from the Agency, a sample before the 180-day deadline. 21 C.F.R. § 171.1(j) (1996). 592.   See, e.g., 57 Fed. Reg. 11,325 (1992). GRAS affirmation petitions allow 60 days for comment, 21 C.F.R § 170.35(c)(3) (1996), and this is also the amount of time provided in the FDA's general procedures for rulemaking. Id. § 10.40(b)(2); see also 55 Fed. Reg. 49,576 (1990) (petition to prohibit BHA). 593.   See 60 Fed. Reg. 57,586, 57,587 (1995) ("Any data, information, or comments received after that [deadline] will be filed in an administrative file and will be evaluated along with any objections to the final decision" on the olestra petition.); 1995 Hearings, supra note 1, at 79 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council) (recommending the adoption of this procedure); see also H.R. REP. NO. 436, 104th Cong., 1st Sess. 13 (1995) (recommending that the FDA refuse to consider any information from anonymous sources). One industry representative suggested that the FD&C Act be amended to shift food additive approvals from formal to informal rulemaking procedures, thereby hoping to speed reviews by reducing the pressure to anticipate objections and requests for an administrative hearing. See FDA Blueprint for Additive Petition Reform Goes to HHS, FOOD CHEM. NEWS, Oct. 30, 1995, at 37, 40.

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    Although it is not clear that officials would be any less worried about the prospect of judicial review, late-filed objections would then become a petition for reconsideration or to amend the final rule. 594.   See 45 Fed. Reg. 31,422, 31,424 (1980) ("New data and information may be submitted after the 90-day comment period but will not be included as part of the administrative record for consideration by the agency until after the administrative record is reopened following publication of a [TFM] . . . ."); see also Noah, supra note 573, at 72 ("[L]egislators and regulators must ensure that opportunities for intervention are circumscribed so that incumbent firms cannot inappropriately inhibit competition."). 595.   See 21 C.F.R. § 330.10(a)(7)(v) (1996) (unless "good cause has been shown that warrants earlier consideration"); 45 Fed. Reg. at 31,424 (the FDA "will not include such [late-filed] data in its consideration of the content of a final monograph."); see also Noah, supra note 573, at 67 ("For example, intervention might be permitted only at a particular stage in the proceedings and in such a way as not to delay agency action."). 596.   See 21 C.F.R. § 171.130(b) (1996) ("Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal."). 597.   Existing certification requirements suffer from certain limitations, however, especially a lack of effective monitoring and enforcement by the responsible agencies. See Noah, supra note 573, at 53-58. "Although agencies might do well to demand closer adherence to the rules of professional responsibility or impose certification requirements akin to Rule 11, ultimately more stringent restrictions on participation may be necessary to combat abuse of the regulatory process." Id. at 58. 598.   21 C.F.R. § 10.30(b) (1996). A food additive petition must be signed by the petitioner or by its attorney or agent, id. § 171.1(e), and it "shall not omit without explanation any reports of investigations that would bias an evaluation of the safety of the food additive." Id. § 171.1(c)(E); see also 1995 Hearings, supra note 1, at 78 (statement of Robert C. Gelardi, Executive Vice President, Calorie Control Council) (complaining that "nonpetitioner submissions are accorded a full review without hard data, or peer review, and when indeed they often are no more than opinion"). 599.   See supra Part II.B. Although the FDA has published "positive" GRAS lists, these do not exhaust the range of possible GRAS substances. See 21 C.F.R. §§ 170.30(d), 182.1 (1996). The only substances for which GRAS status could never be asserted include those subject to a food additive regulation or an outright prohibition. See id. §§ 170.38, 182.1(d), 189.1. Absence from one of these "negative" lists would not, however, automatically authorize the use of a substance unless it also satisfies the general criteria for GRAS status. 600.   See generally ROGER D. MIDDLEKAUFF & PHILIPPE SHUBIK eds., INTERNATIONAL FOOD REGULATION HANDBOOK 329479 (1989) (summarizing regulatory approaches to food and food additives in Belgium, France, Denmark, Israel, Egypt, Thailand, and Australia). 601.   See, e.g., 60 Fed. Reg. 53,078, 53,080 (1995) (describing the FDA's participation in international activities related to the establishment of food standards); 60 Fed. Reg. 11,260-87 (1995) (announcing international guidelines for the testing of human pharmaceuticals); Joseph G. Contrera, Comment, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious will International Pharmaceutical Regulations Become?, 8 ADMIN. L.J. 927 (1995). 602.   See Interim Patent Extension Hearing, supra note 438, at 16 (testimony of Bruce A. Lehman, Commissioner of Patents and Trademarks) ("[W]e are fairly advanced in the biotechnology, biochemical area and . . . normally we are the first country to have these regulatory review problems."). But cf Burros, supra note 434, at C1 (reporting that olestra has been under review for a number of years in Britain and Canada). 603.   See 1995 Hearings, supra note 1, at 162, 166 (testimony of Donald Farley, President, Food Science Group, Pfizer, Inc.) ("[S]ome companies are conducting research offshore simply for that purpose; they obtain faster approvals in foreign countries, who have a professional regulatory authority who review detailed safety petitions."). 604.   In contrast, comparative data exist for drug approval times. See, e.g., Rosemarie Kanusky, Comment, Pharmaceutical Harmonization : Standardizing Regulations Among the United States, the European Economic Community, and Japan, 16 HOUS. J. INT'L L. 665, 686 (1994). 605.   R.S.C., ch. F-27 (1985) (Can.).

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606.   See D.G. Chapman, Current Topics in Canadian Food Regulatory Affairs, 30 FOOD DRUG COSM. L.J. 654, 655-56 (1975); A.B. Morrison, The Canadian Approach to Food and Drug Regulations, 30 FOOD DRUG COSM. L.J. 632 (1975); Ron O. Read, Food Safety and Regulations—A Canadian Perspective, 36 FOOD DRUG COSM. L.J. 120 (1981). 607.   R.S.C. ch. F-27, §§ 4(a), 30(1)(b)(iv). 608.   C.R.C. ch. 870, § B.01.001 (1996). 609.   See id.; see also Read, supra note 606, at 125 ("The major reason for some of the exemptions such as flavors and packaging materials at the time of drafting the food additive regulations was based on the premise that there was only a remote possibility of hazard to health because of the small amount added or migrating into foods."). Instead, the HPB issues regulations prohibiting these substances when necessary. See Chapman, supra note 606, at 655 ("We have found this practice [of "negative" listing] to be a good alternative to the [FDA] policy of attempting to list all permitted flavoring materials and components of packaging materials."). 610.   See 1995 Hearings, supra note 1, at 168 (statement of Jerome H. Heckman, on behalf of the Society of the Plastics Industry) ("[T]hey use a system in Canada that is more like premarket notification . . . . There are three people that work on indirect additive no objection letter requests, and last year they processed 900 of them. They don't have any backlog to speak of."); Read, supra note 606, at 125 ("[W]hile there is no legal requirement to do so, most manufacturers who supply packaging materials to the food industry make submissions to the [HPB] on a continuing basis, requesting the Branch's opinion on the acceptability of their various products."). 611.   C.R.C. ch. 870, § B.01.001 (1996). 612.   See Blake, Cassels & Graydon, Developments in Canadian Law Relating to Food, Drugs, Devices, and Cosmetics as of December 1992, 49 FOOD & DRUG L.J. 323, 342 (1994); Katharine E. Gourlie, NAFTA Countries : Convergence and Fracture, 51 FOOD & DRUG L.J. 423, 429-31 (1996) (adding that special labeling would not routinely be required); see also HPB, Guidelines for the Safety Assessment of Novel Foods (1994). 613.   C.R.C. ch. 870, § B.16.100 (1995). The regulations include fifteen separate tables listing various classes of approved food additives, along with any restrictions on use. For a summary of recent revisions to these regulations, see the "Food Additive Update" section of the annual Encyclopedia of Food Ingredients published in the April issue of FOOD IN CANADA, available in LEXIS, News Library, FDCAN File. 614.   C.R.C. ch. 870, § B.16.002(d) & (e) (1996). 615.   See id. § B.16.003. 616.   See id. § B.16.002; Chapman, supra note 606, at 655-56. 617.   See Erik Millstone, Food Additive Regulation in the UK, 10 FOOD POL'Y 237, 244-45, 252 (1985). See generally David Jukes, Regulation and Enforcement of Food Safety in the UK, 18 FOOD POL'Y 131 (1993). 618.   Food Safety Act, 1990, ch. 16, §§ 7(1), 16(1)(a). For a list of food additive regulations issued under the authority of this statute and its predecessors, see 18 HALSBURY'S STATUTES 502-06 (4th ed. 1991). 619.   See Millstone, supra note 617, at 239, 245 (explaining that, as of 1985, 314 additives in 23 different classes were listed (accounting for less than 10% of all additives in use) and that other classes were subject only to limited negative lists). 620.   See Sweeteners in Food Regulations, S.I. 1995, No. 3123; Colours in Food Regulations, S.I. 1995, No. 3124; Miscellaneous Food Additives Regulations, S.I. 1995, No. 3187; United Kingdom Removes Numerous Outdated Food Composition Regulations, FOOD & DRINK WKLY., Jan. 15, 1996, available in Westlaw, Foodrd File ("Fourteen food additive regulations, dating to 1967, have been revoked and replaced by three sets of regulations that introduce new European Union requirements for colors, sweeteners and other additives."). 621.   See John Abraham & Erik Millstone, Food Additive Controls: Some International Comparisons, 14 FOOD POL'Y 43, 47 (1989) ("This means that [the additive] must perform a function which is not yet performed by any additive already permitted, or else perform it more effectively or more safely."); see also id. at 49 ("It has been a long-standing policy of successive FR German governments not to permit any new additives, or any new uses for those additives which are already permitted, unless there are particularly strong grounds for doing so."). 622.   See id. at 46-47; Millstone, supra note 617, at 245-46. As of 1985, it was estimated that "it takes from three to 10 years to complete the tests and gain a regulatory decision." Millstone, supra note 617, at 252. (The estimate in the U.S. at that time was 5-7 years for direct additives. See 49 Fed. Reg. 50,856, 50,859 (1984).)

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623.   See CHARLES LISTER, REGULATION OF FOOD PRODUCTS BY THE EUROPEAN COMMUNITY (1992). 624.   See EEC Treaty arts. 30 & 36. 625.   See, e.g., Case 178/84, Commission v. Germany, [1987] E.C.R. 1227, [1988] 1 C.M.L.R. 780; Case 304/84, Ministère Public v. Muller & Kampfmeyer-France Sarl, [1986] E.C.R. 1511, [1987] 2 C.M.L.R. 469; Case 247/84 State v. Motte, [1985] E.C.R. 3887, [1987] 1 C.M.L.R. 663; Case 174/82, Officier van Justite v. Sandoz B.V., [1983] E.C.R. 2445, [1984] 3 C.M.L.R. 43; see also Communication on the Free Movement of Foodstuffs Within the Community, 1989 O.J. (C271) 13, at ¶ 38 (interpreting "reasonable time" as 90 days). 626.   See Council Directive 89/107, 1989 O.J. (L40) 27, art. 1(2), amended by 94/34, 1994 O.J. (L237) 1. 627.   See id. art. 1(3). "Processing aid" is defined as a substance used during treatment or processing "which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product." Id. n. 1. 628.   See Common Position 25/95, 1995 O.J. (C320) 1, arts. 3(4) & 5 (proposing to subject certain novel foods and food ingredients to a premarket notification rather than premarket approval process). 629.   Council Directive 89/107, 1989 O.J. (L40) 27, annex II(1). 630.   Id. annex 11(2) ("[I]n other words it is necessary to establish the case for what is commonly referred to as 'need."'). The directive sets forth four purposes—preservation of nutritional quality; provision of a constituent for a special dietary need; enhancement of "keeping quality or stability" or organoleptic properties; and assistance in manufacture, processing, preparation, treatment, packing, transport or storage—but emphasizes that utility for one or more of these broad purposes would not demonstrate "need" unless the purpose(s) cannot be achieved by other practicable means. See id. 631.   Id. annex 11(3) (adding that "[t]he evaluation should also take into account, for example, any cumulative, synergistic or potentiating effect of its use and the phenomenon of human intolerance to substances foreign to the body"). Approval of a food additive must take into account, among other things, "any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources." Id. annex II(6)(c); see also EC Commission, Presentation of an Application for Assessment of a Food Additive Prior to its Authorization (1989) (specifying the safety data and other information required in a dossier). 632.   Council Directive 89/107, 1989 O.J. (L40) 27, art. 2(1). Such substances also must abide by any applicable limitations on use. Id. art. 3(2). Subject to certain conditions, individual member states may provisionally authorize the use of an unlisted additive for no more than two years. See id. art 5. 633.   See Council Directive 2645/62, 1962 O.J. (L279) 1. 634.   See Council Directive 64/54, 1964 O.J. (12) 161; Council Directive 70/357, 1970 O.J. (L157) 31; Council Directive 74/329, 1974 O.J. (L189) 1. 635.   See Council Directive 94/36, 1994 O.J. (L237) 13; Council Directive 94/35, 1994 O.J. (L237) 3; see also Council Directive 95/31, 1995 O.J. (L178) 1 (establishing purity criteria for colors and sweeteners). 636.   See Council Directive 95/2, 1995 O.J. (L61) 1. 637.   See supra note 620. 638.   See Charles Lister, Discord and Change: An Assessment of the European Community's Food Packaging Laws, 48 FOOD & DRUG L.J. 589 (1993); Jean-Philippe Montfort, "The Article 30 Solution": An Alternative to Market Food Contact Materials in the European Union, 51 FOOD & DRUG L.J. 161 (1996). 639.   See Council Directive 88/388, 1988 O.J. (L184) 61 (framework directive concerning the approximation of flavoring laws); see also Mitzi Elkes, Europe 1992: Its Impact on Nontariff Trade Barriers and Trade Relations with the United States, 44 FOOD DRUG COSM. L.J. 563, 581-82 (1989). 640.   See Common Position, 25/95, 1995 O.J. (C320) 1, arts. 1 & 2. (GMOs were defined in Council Directive 90/220, 1990 O.J. (LI 17) 15 (concerning deliberate environmental releases).) Because the Council plans to issue regulations rather than a directive, member states will not first have to modified their domestic laws. 641.   See Common Position, 25/95, 1995 O.J. (C320) 1, arts. 3(1)-(2), 4, 6, 7 & 13. The EU's Scientific Committee for Food (SCF) would play an advisory role. Id. art. 11.

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642.   See id. art. 8. The labeling issue has created significant controversy and delayed work toward adoption of a directive on the subject. See Council to Agree Novel Foods Conciliation, REUTER E.C. REP., July 11, 1996, available in LEXIS, Intlaw Library, ECNews File. 643.   See Peter B. Edelman, Japanese Product Standards as Non-tariff Trade Barriers: When Regulatory Policy Becomes a Trade Issue, 24 STAN. J. INT'L L. 389, 392-94 (1988); Frank K. Upham, The Legal Framework of Japan's Declining Industries Policy: The Problem of Transparency in Administrative Processes, 27 HARV. INT'L L.J. 425 (1986); Ken Duck, Comment, Now That the Fog Has Lifted: The Impact of Japan's Administrative Procedures Law on the Regulation of Industry and Market Governance, 19 FORDHAM INT'L L.J. 1686 (1996); see also David Cohen & Karen Martin, Western Ideology, Japanese Product Safety Regulation and International Trade, 19 U.B.C. L. REV. 315, 348-49 (1985) (mentioning positive list and approval process for food additives). 644.   See Highlights of U.S. Trade Barrier Report, JAPAN WKLY. MONITOR, Apr. 8, 1996, available in LEXIS, News Library, Iacwld File; Hiroshi Nakamae, USTR Report Targets Japan as Closed Market, NIKKEI WKLY., Apr. 4, 1994, available in LEXIS, Busfin Library, Nikkei File; see also Commission Statement on EU-Japan Ministerial Meeting, REUTER E.C. REP., Apr. 29, 1996, available in LEXIS, Eurcom Library, Reuec File (noting that "a dialogue on food additive regulation will soon begin"); Japan Joins West in Food-Safety Research, NIKKEI WKLY., Mar. 11, 1996, available in LEXIS, Busfin Library, Nikkei File. 645.   See MINISTRY OF HEALTH AND WELFARE, JAPANESE STANDARDS FOR FOOD ADDITIVES (6th ed. (English) 1994), reviewed in JAPAN CHEM. WEEK, May 19, 1994, at 8. 646.   See Japan: Koseisho to Relax Standards for Nine Food Additives, REUTER TEXTLINE, Oct. 3, 1992, available in LEXIS, World Library, Txtlne File (adding that the approvals for over 200 of these compounds include restrictions on use); see also MICHAEL ASH & IRENE ASH, HANDBOOK OF FOOD ADDITIVES 999-1017 (1995). 647.   See Consumer Groups Target Food Additives, NIKKEI WKLY., Sept. 18, 1995, available in LEXIS, Busfin Library, Nikkei File ("Japan's Food Sanitation Law was revised last May for the first time in 23 years. The amendments added Japan's first controls on natural food additives . . . [and the] Ministry released a list of 466 natural additives that will be approved under the new law."). 648.   See Ministry of Health & Welfare, Draft Guidelines for Designation of Food Additives and for Revision of Standards for the Use of Food Additives (1995); Japan: Draft on Food Additive Deregulation Prepared, REUTER TEXTLINE, July 17, 1995, available in LEXIS, World Library, Txtlne File (reporting that the draft "calls for a sweeping revision of the 1965 report with respect to the range of toxicity tests required for safety evaluations and the need for guidelines showing the standard test methods and is aimed at greater speed and transparency in the procedures to designate food additives"). 649.   See Japan's Bioindustry—Genetic Recombination Starting to Bear Fruit, JAPAN CHEM. WEEK, Nov. 17, 1994, at 7; Great Expectation for Foodstuffs, JAPAN CHEM. WEEK, Nov. 18, 1993, at 4. 650.   Ministry of Health & Welfare, Guidelines for Safety Assessments of Foods and Food Additives Produced by Recombinant DNA Techniques (1992). 651.   See Japan: Group Confirms Safety of rDNA Chymosin, REUTER TEXTLINE, June 27, 1994, available in LEXIS, World Library, Txtlne File; Japan Trials of Recombinant Chymosin to Begin, REUTER TEXTLINE, Jan. 18, 1994, available in LEXIS, World Library, Txtlne File. 652.   See supra note 401.