Starting from scratch?: Reinventing the food additive approval process

Boston University Law Review

Volumn 78, Issue 2, 1998, Pages 329-442

  Noah, Lars ^a   Merrill, Richard A ^b  

^a UNIVERSITY OF FLORIDA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

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EID: 0032262634     PISSN: 00068047     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (69)

1. See, e.g., Delays in the FDA's Food Additive Petition Process and GRAS Affirmation Process: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Gov't Reform and Oversight, 104th Cong. (1995) [hereinafter 1995 Hearings] (examining the reasons for, and consequences of, delays in the FDA's review of food additive petitions and the GRAS affirmation process); Peter Barton Hutt, Approval of Food Additives in the United States: A Bankrupt System, FOOD TECH., Mar. 1996, at 118, 122 (arguing that the FDA's regulation of food additives has failed because of the Agency's sluggish review process).
2. See, e.g., Delays in the FDA's Food Additive Petition Process and GRAS Affirmation Process: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Gov't Reform and Oversight, 104th Cong. (1995) [hereinafter 1995 Hearings] (examining the reasons for, and consequences of, delays in the FDA's review of food additive petitions and the GRAS affirmation process); Peter Barton Hutt, Approval of Food Additives in the United States: A Bankrupt System, FOOD TECH., Mar. 1996, at 118, 122 (arguing that the FDA's regulation of food additives has failed because of the Agency's sluggish review process).
3. See, e.g., Delays in the FDA's Food Additive Petition Process and GRAS Affirmation Process: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Gov't Reform and Oversight, 104th Cong. (1995) [hereinafter 1995 Hearings] (examining the reasons for, and consequences of, delays in the FDA's review of food additive petitions and the GRAS affirmation process); Peter Barton Hutt, Approval of Food Additives in the United States: A Bankrupt System, FOOD TECH., Mar. 1996, at 118, 122 (arguing that the FDA's regulation of food additives has failed because of the Agency's sluggish review process).
4. See, e.g., THOMAS O. MCGARITY & SIDNEY A. SHAPIRO, WORKERS AT RISK: THE FAILED PROMISE OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (1993) (suggesting improvements in the Occupational Safety and Health Administration's regulatory process); JERRY L. MASHAW & DAVID L. HARFST, THE STRUGGLE FOR AUTO SAFETY (1990) (evaluating the National Highway Traffic Safety Administration's regulatory efforts to promote automobile safety); GLEN O. ROBINSON, THE FOREST SERVICE: A STUDY IN PUBLIC LAND MANAGEMENT (1975) (analyzing the U.S. Forest Service's organizational and administrative process in the context of general public land management); JAMES Q. WILSON, THE POLITICS OF REGULATION (1980) (collecting essays describing how various regulatory agencies ordinarily operate).
5. See, e.g., THOMAS O. MCGARITY & SIDNEY A. SHAPIRO, WORKERS AT RISK: THE FAILED PROMISE OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (1993) (suggesting improvements in the Occupational Safety and Health Administration's regulatory process); JERRY L. MASHAW & DAVID L. HARFST, THE STRUGGLE FOR AUTO SAFETY (1990) (evaluating the National Highway Traffic Safety Administration's regulatory efforts to promote automobile safety); GLEN O. ROBINSON, THE FOREST SERVICE: A STUDY IN PUBLIC LAND MANAGEMENT (1975) (analyzing the U.S. Forest Service's organizational and administrative process in the context of general public land management); JAMES Q. WILSON, THE POLITICS OF REGULATION (1980) (collecting essays describing how various regulatory agencies ordinarily operate).
6. See, e.g., THOMAS O. MCGARITY & SIDNEY A. SHAPIRO, WORKERS AT RISK: THE FAILED PROMISE OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (1993) (suggesting improvements in the Occupational Safety and Health Administration's regulatory process); JERRY L. MASHAW & DAVID L. HARFST, THE STRUGGLE FOR AUTO SAFETY (1990) (evaluating the National Highway Traffic Safety Administration's regulatory efforts to promote automobile safety); GLEN O. ROBINSON, THE FOREST SERVICE: A STUDY IN PUBLIC LAND MANAGEMENT (1975) (analyzing the U.S. Forest Service's organizational and administrative process in the context of general public land management); JAMES Q. WILSON, THE POLITICS OF REGULATION (1980) (collecting essays describing how various regulatory agencies ordinarily operate).
7. See, e.g., THOMAS O. MCGARITY & SIDNEY A. SHAPIRO, WORKERS AT RISK: THE FAILED PROMISE OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (1993) (suggesting improvements in the Occupational Safety and Health Administration's regulatory process); JERRY L. MASHAW & DAVID L. HARFST, THE STRUGGLE FOR AUTO SAFETY (1990) (evaluating the National Highway Traffic Safety Administration's regulatory efforts to promote automobile safety); GLEN O. ROBINSON, THE FOREST SERVICE: A STUDY IN PUBLIC LAND MANAGEMENT (1975) (analyzing the U.S. Forest Service's organizational and administrative process in the context of general public land management); JAMES Q. WILSON, THE POLITICS OF REGULATION (1980) (collecting essays describing how various regulatory agencies ordinarily operate).
8. See Pure Food and Drugs Act, Pub. L. No. 59-384, ch. 3915, § 2, 34 Stat. 768 (1906) (superseded by the FD&C Act in 1938).
9. Id. § 7.
10. United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411 (1914) ("If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such [product], though having a small addition of poisonous or deleterious ingredients, may not be condemned under the act."); see also United States v. Coca Cola Co., 241 U.S. 265, 279-85 (1916) (holding that caffeine added to beverage syrup was an "added" ingredient and that the government's evidence that caffeine was poisonous or deleterious should have been submitted to the jury).
11. Pub. L. No. 75-717, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 321-393 (1994)). The statute refers throughout to the Secretary of Health and Human Services (previously the Secretary of Health, Education and Welfare (HEW) and before that the Secretary of Agriculture (USDA)), see 21 U.S.C. § 321(d), but the Secretary has delegated most powers under the FD&C Act to the Commissioner of Food and Drugs, see id. § 393(b); 21 C.F.R. §§ 5.10(a)(1), 5.11(a) (1997).
12. Pub. L. No. 85-929, 72 Stat. 1784 (1958) (codified as amended in scattered sections of 21 U.S.C.).
13. See 104 CONG. REC. 17,417 (1958) (statement of Hon. John B. Williams) ("The 1938 law gave no recognition to substances deliberately added to food for beneficial purposes, such as retarding natural spoilage or keeping food moist or tasty. There is a gap in our pure food law as a result of advancing technology.").
14. See, e.g., GENERAL ACCOUNTING OFFICE, FOOD SAFETY AND QUALITY: INNOVATIVE STRATEGIES MAY BE NEEDED TO REGULATE NEW FOOD TECHNOLOGIES, No. RCED-93-142 (1993), at 1-2, 5 [hereinafter GAO, NEW FOOD TECHNOLOGIES] (discussing new food technologies, various possible responses to these new technologies, and unresolved regulatory issues).
15. FD&C Act § 402(a) (codified as amended at 21 U.S.C. § 342(a)). Section 406 of the Act provided: 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 . . . . Id. § 406(a) (codified as amended at 21 U.S.C. § 346); see also H.R. REP. NO. 75-2139, at 6 (1938) (explaining that the tolerance setting provision would provide greater flexibility in dealing with pesticide residues); Richard A. Merrill, Regulating Carcinogens in Food: A Legislator's Guide to the Food Safety Provisions of the Federal Food, Drug, and Cosmetic Act, 77 MICH. L. REV. 171, 175 (1978) ("In substance, Congress authorized the FDA to license the use of some potentially toxic substances in food, apparently in recognition of their utility or of the importance of foods from which they cannot practicably be eliminated.").
16. FD&C Act § 402(a) (codified as amended at 21 U.S.C. § 342(a)). Section 406 of the Act provided: 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 . . . . Id. § 406(a) (codified as amended at 21 U.S.C. § 346); see also H.R. REP. NO. 75-2139, at 6 (1938) (explaining that the tolerance setting provision would provide greater flexibility in dealing with pesticide residues); Richard A. Merrill, Regulating Carcinogens in Food: A Legislator's Guide to the Food Safety Provisions of the Federal Food, Drug, and Cosmetic Act, 77 MICH. L. REV. 171, 175 (1978) ("In substance, Congress authorized the FDA to license the use of some potentially toxic substances in food, apparently in recognition of their utility or of the importance of foods from which they cannot practicably be eliminated.").
17. FD&C Act § 401 (codified as amended at 21 U.S.C. § 341); see also Federal Sec. Admin, v. Quaker Oats Co., 318 U.S. 218, 227-31 (1943) (upholding "standards of identity" which were adopted in order to avoid consumer confusion); Atlas Powder Co. v. Ewing, 201 F.2d 347, 350-55 (3d Cir. 1952) (upholding FDA decision, after almost one decade of hearings, not to permit the use of certain emulsifiers in bread because of unresolved safety concerns and the risk of consumer deception); Richard A. Merrill & Earl M. Collier, Jr., "Like Mother Used to Make": An Analysis of FDA Food Standards of Identity, 74 COLUM. L. REV. 561, 600 (1974) (establishing a framework for analyzing the costs and benefits of food standards). The FDA did have limited premarket approval powers under the 1938 Act through the listing and batch certification provisions applicable to coal-tar colors used in food. See FD&C Act § 406(b), 52 Stat. 1040, 1049 (1938), repealed and replaced by Color Additive Amendments of 1960, Pub. L. No. 86-618, tit. I, 74 Stat. 397 (codified as amended at 21 U.S.C. § 379e).
18. See 21 U.S.C. § 331(a)-(c) (designating the adulteration of food, or its delivery or receipt, in interstate commerce as prohibited acts); id. § 332(a) (authorizing injunctions to restrain violations of the Act); id. § 334(a) (authorizing seizure of products in violation of the Act); see also id. § 333(a) (authorizing the imposition of criminal penalties for violations of the Act); United States v. Park, 421 U.S. 658, 671-74 (1975) (affirming the imposition of strict criminal liability under the FD&C Act in a case involving food adulteration); Brenda A. Bachman & Lori Ludemann, Note, Federal Food and Drug Act Violations, 33 AM. CRIM. L. REV. 757 (1996) (examining the criminal provisions of the FD&C Act). In practice, the FDA typically sends a warning letter first, threatening to pursue formal enforcement action only if the company fails to bring itself into prompt compliance. See Warning Letters; Procedure Manual, Chapter 8-10; Availability, 56 Fed. Reg. 27,026 (1991).
19. See, e.g., United States v. 29 Cartons of * * * An Article of Food, 987 F.2d 33, 35 (1st Cir. 1993) ("[T]Ke FDA can prevent sale of bottled BCO or any other 'food' only if it proves by a preponderance of the evidence that the food is 'injurious to health.'"); United States v. Boston Farm Ctr., Inc., 590 F.2d 149, 153 (5th Cir. 1979) ("[I]n this case the expert evidence is uncontradicted that 20 ppb of aflatoxin may render corn harmful."); United States v. 2,116 Boxes of Boned Beef * * *, 516 F. Supp. 321, 328-30 (D. Kan. 1981) (holding that, under the identically-phrased adulteration provision in the Federal Meat Inspection Act, the government must prove a reasonable possibility of harmfulness), aff'd, 726 F.2d 1481, 1485 (10th Cir. 1984); United States v. Anderson Seafoods, Inc., 447 F. Supp. 1151, 1155-56 (N.D. Fla. 1978) (holding that the injuriousness requirement does not mean harmfulness under any conceivable conditions of use), aff'd, 622 F.2d 157, 159 (5th Cir. 1980) ("The 'may render' standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer."); see also United States v. Coca Cola Co., 241 U.S. 265, 284-85 (1916) (construing similar language in predecessor statute).
20. Pure Food and Drugs Act, Pub. L. No. 59-384, ch. 3915, § 7, 34 Stat. 768 (1906) (superseded by the FD&C Act in 1938).
21. See United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411 (1914) ("If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such [bleached] flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under the [1906] act."); see also Flemming v. Florida Citrus Exch., 358 U.S. 153, 161 (1958) (applying the holding of Lexington Mill to the adulteration provisions of the FD&C 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"). See Merrill, supra note 10, at 189 ("The sparse case law suggests that the agency would have to demonstrate a probability of harm to some significant number of consumers."). Thus, the FDA often has stretched the concept of "added" so that it could act against harmful substances even though they were not intentionally added to food. See, e.g., Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 42-43 (D.C. Cir. 1982) (salmonella in shrimp); United States v. Anderson Seafoods, Inc., 622 F.2d 157, 160-61 (5th Cir. 1980) (mercury contamination in fish); Richard A. Merrill & Michael Schewel, FDA Regulation of Environmental Contaminants of Food, 66 VA. L. REV. 1357, 1372-75 (1980) (discussing the judicial acceptance of the FDA's expansive interpretation of the term "added"); James D. Poliquin, Comment, The Incremental Development of an Extra-Statutory System of Regulation: A Critique of Food and Drug Administration Regulation of Added Poisonous and Deleterious Substances, 33 ME. L. REV. 103, 108-15 (1981) (describing some of the purposes behind the FDA's expansive interpretation of the term "added").
22. See United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411 (1914) ("If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such [bleached] flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under the [1906] act."); see also Flemming v. Florida Citrus Exch., 358 U.S. 153, 161 (1958) (applying the holding of Lexington Mill to the adulteration provisions of the FD&C 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"). See Merrill, supra note 10, at 189 ("The sparse case law suggests that the agency would have to demonstrate a probability of harm to some significant number of consumers."). Thus, the FDA often has stretched the concept of "added" so that it could act against harmful substances even though they were not intentionally added to food. See, e.g., Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 42-43 (D.C. Cir. 1982) (salmonella in shrimp); United States v. Anderson Seafoods, Inc., 622 F.2d 157, 160-61 (5th Cir. 1980) (mercury contamination in fish); Richard A. Merrill & Michael Schewel, FDA Regulation of Environmental Contaminants of Food, 66 VA. L. REV. 1357, 1372-75 (1980) (discussing the judicial acceptance of the FDA's expansive interpretation of the term "added"); James D. Poliquin, Comment, The Incremental Development of an Extra-Statutory System of Regulation: A Critique of Food and Drug Administration Regulation of Added Poisonous and Deleterious Substances, 33 ME. L. REV. 103, 108-15 (1981) (describing some of the purposes behind the FDA's expansive interpretation of the term "added").
23. See H.R. REP. NO. 85-2284, at 1 (1958) ("[T]o prove an untested substance poisonous or deleterious may require approximately 2 years or more of laboratory experiments with small animals and during this period the Government cannot prevent the use of such a substance in food."); Federal Food, Drug, and Cosmetic Act (Chemical Additives in Food): Hearings Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 84th Cong. 71 (1956) [hereinafter 1956 Hearings] (statement of Glenn G. Paxton, appearing as counsel for various food industry associations) ("Today FDA must do its own testing and experimentation on an additive - admittedly a difficult task - and must sustain the burden of proof that it is poisonous or deleterious - admittedly a difficult burden - before it can obtain a court order to restrain its use."); Merrill, supra note 10, at 194 ("To enforce section 402(a)(1), the FDA ordinarily must locate contaminated food, conduct chemical analyses, find witnesses prepared to testify that the amount of the contaminant is potentially harmful to some portion of consumers, and prove these facts in court.").
24. See H.R. REP. NO. 85-2284, at 1 (1958) ("[T]o prove an untested substance poisonous or deleterious may require approximately 2 years or more of laboratory experiments with small animals and during this period the Government cannot prevent the use of such a substance in food."); Federal Food, Drug, and Cosmetic Act (Chemical Additives in Food): Hearings Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 84th Cong. 71 (1956) [hereinafter 1956 Hearings] (statement of Glenn G. Paxton, appearing as counsel for various food industry associations) ("Today FDA must do its own testing and experimentation on an additive - admittedly a difficult task - and must sustain the burden of proof that it is poisonous or deleterious - admittedly a difficult burden - before it can obtain a court order to restrain its use."); Merrill, supra note 10, at 194 ("To enforce section 402(a)(1), the FDA ordinarily must locate contaminated food, conduct chemical analyses, find witnesses prepared to testify that the amount of the contaminant is potentially harmful to some portion of consumers, and prove these facts in court.").
25. See 21 U.S.C. §§ 342(a)(2), 346 (1994); Young v. Community Nutrition Inst., 476 U.S. 974, 977, 981-84 (1986) (noting that any added poisonous or deleterious substance for which no tolerance existed would be unsafe, but holding that the statute did not compel the Agency to regard such a substance as adulterated); United States v. Ewig Bros. Co., 502 F.2d 715, 720 (7th Cir. 1974) (describing the "per se" adulteration approach established by Section 406 for any poisonous or deleterious substance for which no tolerance had been promulgated). The phrase "poisonous or deleterious" is not separately defined in the statute, and the FDA has declined to include a definition in its implementing regulations. See Poisonous or Deleterious Substances, 42 Fed. Reg. 52,814, 52,816 (1977).
26. See H.R. REP. NO. 85-2284, at 1-2 ("[P]resent law entirely prohibits the use of these additives even if their use at safe levels would advance our food technology and increase and improve our food supplies."); 1956 Hearings, supra note 16, at 194 (statement of George P. Larrick, Comm'r, FDA) ("Once it was shown that the proposed additive was a poison, it was excluded unless it was necessary in production or unavoidable in good manufacturing practice. Over the years, only the pesticide chemicals have met this test of necessity.").
27. See H.R. REP. NO. 85-2284, at 1-2 ("[P]resent law entirely prohibits the use of these additives even if their use at safe levels would advance our food technology and increase and improve our food supplies."); 1956 Hearings, supra note 16, at 194 (statement of George P. Larrick, Comm'r, FDA) ("Once it was shown that the proposed additive was a poison, it was excluded unless it was necessary in production or unavoidable in good manufacturing practice. Over the years, only the pesticide chemicals have met this test of necessity.").
28. See Merrill, supra note 10, at 195-98 & nn.89 & 92 (discussing the regulatory framework provided by Sections 402(a)(2) and 406); Poliquin, supra note 15, at 111-15 (applying Sections 402(a)(2) and 406 to five fact patterns).
29. See 1956 Hearings, supra note 16, at 112 (statement of J.M. Gillet, Mfg. Chemists' Ass'n) ("Under the present law there is no requirement that the [FDA] be advised in advance of the use of any new chemical, and it has been up to them to find out that such chemical is being used," though most manufacturers voluntarily provide notification.).
30. See, e.g., Robert C. Brown, The Liability of Retail Dealers for Defective Food Products, 23 MINN. L. REV. 585, 596-610 (1939); R.D. Hursh, Annotation, Liability of Manufacturer or Seller for Injury Caused by Food or Food Product Sold, 77 A.L.R.2d 7 (1961). For a more recent survey of decisions in this area, see Jane M. Draper, Annotation, Liability for Injury or Death Allegedly Caused by Spoilage, Contamination, or Other Deleterious Condition of Food or Food Product, 2 A.L.R.5th 1, 41-82 (1992).
31. See, e.g., Robert C. Brown, The Liability of Retail Dealers for Defective Food Products, 23 MINN. L. REV. 585, 596-610 (1939); R.D. Hursh, Annotation, Liability of Manufacturer or Seller for Injury Caused by Food or Food Product Sold, 77 A.L.R.2d 7 (1961). For a more recent survey of decisions in this area, see Jane M. Draper, Annotation, Liability for Injury or Death Allegedly Caused by Spoilage, Contamination, or Other Deleterious Condition of Food or Food Product, 2 A.L.R.5th 1, 41-82 (1992).
32. See, e.g., Robert C. Brown, The Liability of Retail Dealers for Defective Food Products, 23 MINN. L. REV. 585, 596-610 (1939); R.D. Hursh, Annotation, Liability of Manufacturer or Seller for Injury Caused by Food or Food Product Sold, 77 A.L.R.2d 7 (1961). For a more recent survey of decisions in this area, see Jane M. Draper, Annotation, Liability for Injury or Death Allegedly Caused by Spoilage, Contamination, or Other Deleterious Condition of Food or Food Product, 2 A.L.R.5th 1, 41-82 (1992).
33. See Food Additives: Hearings Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 85th Cong. 421-22 (1957) [hereinafter 7957 Hearings (even though the final session of the hearings took place in 1958)] (statement of Elliot L. Richardson, Asst. Secretary, Health, Education & Welfare (HEW)) ("The commendable actions of the great majority [of companies], however, cannot provide protection against the minority. We have had some narrow escapes in the food field.").
34. See 96 CONG. REC. 8933 (1950). Congress called for an investigation into the nature, extent, and effect of the use of chemicals, compounds, and synthetics in the production, processing, preparation, and packaging of food products to determine the effect of such chemicals, compounds, and synthetics (A) upon the health and welfare of the Nation and (B) upon the stability and well-being of our agricultural economy. Id.
35. See 96 CONG. REC. 8933 (1950). Congress called for an investigation into the nature, extent, and effect of the use of chemicals, compounds, and synthetics in the production, processing, preparation, and packaging of food products to determine the effect of such chemicals, compounds, and synthetics (A) upon the health and welfare of the Nation and (B) upon the stability and well-being of our agricultural economy. Id.
36. See Chemicals in Foods and Cosmetics: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong. (1952); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 82d Cong. (1951); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 81st Cong. (1950).
37. See Chemicals in Foods and Cosmetics: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong. (1952); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 82d Cong. (1951); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 81st Cong. (1950).
38. See Chemicals in Foods and Cosmetics: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong. (1952); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 82d Cong. (1951); Chemicals in Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemicals in Food Products, 81st Cong. (1950).
39. H.R. REP. NO. 82-2356, at 4 (1952); see also National Academy of Sciences, The Use of Chemical Additives in Food Processing, NAS PUB. No. 398 (1956); Report of the Joint FAO/WHO Expert Committee on Food Additives, General Principles Governing the Use of Food Additives (1956).
40. H.R. REP. NO. 82-2356, at 4 (1952); see also National Academy of Sciences, The Use of Chemical Additives in Food Processing, NAS PUB. No. 398 (1956); Report of the Joint FAO/WHO Expert Committee on Food Additives, General Principles Governing the Use of Food Additives (1956).
41. H.R. REP. NO. 82-2356, at 4 (1952); see also National Academy of Sciences, The Use of Chemical Additives in Food Processing, NAS PUB. No. 398 (1956); Report of the Joint FAO/WHO Expert Committee on Food Additives, General Principles Governing the Use of Food Additives (1956).
42. See H.R. REP. NO. 82-2356, at 3-4; see also 1957 Hearings, supra note 22, at 421 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("The potential danger of food additives, indeed, is more insidious [than untested drugs] because it is a danger from the daily intake of small amounts of chemical substances. . . ."); cf. id. at 167 (statement of Hon. Leonor K. Sullivan) ("Seldom do the chemicals add anything of nutritional value. Mostly, they are intended to cut costs, or to cut corners, or to cut spoilage or waste. They are put into the foods mostly for the manufacturer's benefit . . . rather than the consumer's.").
43. See H.R. REP. NO. 82-2356, at 3-4; see also 1957 Hearings, supra note 22, at 421 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("The potential danger of food additives, indeed, is more insidious [than untested drugs] because it is a danger from the daily intake of small amounts of chemical substances. . . ."); cf. id. at 167 (statement of Hon. Leonor K. Sullivan) ("Seldom do the chemicals add anything of nutritional value. Mostly, they are intended to cut costs, or to cut corners, or to cut spoilage or waste. They are put into the foods mostly for the manufacturer's benefit . . . rather than the consumer's.").
44. See H.R. REP. NO. 82-2356, at 3-4; see also 1957 Hearings, supra note 22, at 421 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("The potential danger of food additives, indeed, is more insidious [than untested drugs] because it is a danger from the daily intake of small amounts of chemical substances. . . ."); cf. id. at 167 (statement of Hon. Leonor K. Sullivan) ("Seldom do the chemicals add anything of nutritional value. Mostly, they are intended to cut costs, or to cut corners, or to cut spoilage or waste. They are put into the foods mostly for the manufacturer's benefit . . . rather than the consumer's.").
45. See H.R. REP. NO. 82-2356, at 4. Subsequent estimates ran much higher. See, e.g., Food Additives: Competitive, Regulatory, and Safety Problems: Hearings Before the Senate Select Comm. on Small Bus., 95th Cong. 52 (1977) (statement of Sherwin Gardner, Acting Comm'r, FDA) ("There are over 400 nonflavor GRAS substances; approximately 1,650 flavors and spices, some of which are GRAS and some regulated additives; about 400 regulated direct food additives and on the order of 10,000 GRAS and regulated indirect additives.").
46. See H.R. REP. NO. 82-2356, at 4. Subsequent estimates ran much higher. See, e.g., Food Additives: Competitive, Regulatory, and Safety Problems: Hearings Before the Senate Select Comm. on Small Bus., 95th Cong. 52 (1977) (statement of Sherwin Gardner, Acting Comm'r, FDA) ("There are over 400 nonflavor GRAS substances; approximately 1,650 flavors and spices, some of which are GRAS and some regulated additives; about 400 regulated direct food additives and on the order of 10,000 GRAS and regulated indirect additives.").
47. See H.R. REP. NO. 82-2356, at 27. Some scientists viewed the Committee's conclusions as largely unsupported and inappropriately alarmist. See, e.g., Maurice H. Seevers, Perspective Versus Caprice in Evaluating Toxicity of Chemicals in Man, 153 JAMA 1329, 1331-32 (1953) ("[Representative Delaney's] lurid article, a masterpiece of innuendo and fantasy, based principally on conjecture, was designed for the one purpose of frightening the [consumer] into demanding further legislation.").
48. See H.R. REP. NO. 82-2356, at 27. Some scientists viewed the Committee's conclusions as largely unsupported and inappropriately alarmist. See, e.g., Maurice H. Seevers, Perspective Versus Caprice in Evaluating Toxicity of Chemicals in Man, 153 JAMA 1329, 1331-32 (1953) ("[Representative Delaney's] lurid article, a masterpiece of innuendo and fantasy, based principally on conjecture, was designed for the one purpose of frightening the [consumer] into demanding further legislation.").
49. See, e.g., 1957 Hearings, supra note 22, at 43-49 (reproducing a chart prepared by subcommittee staff comparing the various food additive bills introduced in 1957).
50. See S. REP. NO. 85-2422, at 3-4 (1958) (describing extensive hearings leading up to the consideration of the final bill); 1957 Hearings, supra note 22, at 50 (statement of Hon. John B. Williams, Subcomm. Chairman) ("I]t seems to me that a 10-year period is a sufficiently long incubation period even for difficult legislation."); Vincent A. Kleinfeld, "Chemicals in Foods" - A Legal Viewpoint, 9 FOOD DRUG COSM. L.J. 115 (1954) (discussing the initial efforts at drafting legislation to regulate food additives).
51. See S. REP. NO. 85-2422, at 3-4 (1958) (describing extensive hearings leading up to the consideration of the final bill); 1957 Hearings, supra note 22, at 50 (statement of Hon. John B. Williams, Subcomm. Chairman) ("I]t seems to me that a 10-year period is a sufficiently long incubation period even for difficult legislation."); Vincent A. Kleinfeld, "Chemicals in Foods" - A Legal Viewpoint, 9 FOOD DRUG COSM. L.J. 115 (1954) (discussing the initial efforts at drafting legislation to regulate food additives).
52. See S. REP. NO. 85-2422, at 3-4 (1958) (describing extensive hearings leading up to the consideration of the final bill); 1957 Hearings, supra note 22, at 50 (statement of Hon. John B. Williams, Subcomm. Chairman) ("I]t seems to me that a 10-year period is a sufficiently long incubation period even for difficult legislation."); Vincent A. Kleinfeld, "Chemicals in Foods" - A Legal Viewpoint, 9 FOOD DRUG COSM. L.J. 115 (1954) (discussing the initial efforts at drafting legislation to regulate food additives).
53. See Pub. L. No. 83-518, § 3 (408(a)), 68 Stat. 511 (1954) (codified at 21 U.S.C. § 346a(a) (1994)), repealed and replaced by Food Quality Protection Act of 1996, Pub. L. No. 104-170, § 405, 110 Stat. 1514.
54. See 104 CONG. REC. 19,359 (1958) (statement of Sen. Hill) ("[T]his measure now has the overwhelming support of the major industrial and business concerns which would be affected by it."). As the Committee Chairman reported: The industries concerned - those who manufacture the chemicals in question and those who use them in connection with food products - and the Government agencies are in agreement that an advance determination by the Government as to the acceptability of a chemical in connection with foods is desirable from the point of view both of the industries concerned, the Government, and the consumer. 1956 Hearings, supra note 16, at 1-2 (statement of Hon. J. Percy Pierce).
55. See 104 CONG. REC. 19,359 (1958) (statement of Sen. Hill) ("[T]his measure now has the overwhelming support of the major industrial and business concerns which would be affected by it."). As the Committee Chairman reported: The industries concerned - those who manufacture the chemicals in question and those who use them in connection with food products - and the Government agencies are in agreement that an advance determination by the Government as to the acceptability of a chemical in connection with foods is desirable from the point of view both of the industries concerned, the Government, and the consumer. 1956 Hearings, supra note 16, at 1-2 (statement of Hon. J. Percy Pierce).
56. See, e.g., 1956 Hearings, supra note 16, at 73 (statement of Glenn G. Paxton, appearing as counsel for various food industry associations) (observing that "the consensus among the food group was that this is a subject that does not require a strict licensing ar-rangement by the [FDA]"); id. at 91 (supporting a "provision to the effect that after an unfavorable opinion by the Secretary the proponent may not use the additive without first giving to the Secretary at least 30 days notice of intended use, which would enable the Secretary to institute any type of legal action which he deems advisable").
57. See, e.g., 1956 Hearings, supra note 16, at 73 (statement of Glenn G. Paxton, appearing as counsel for various food industry associations) (observing that "the consensus among the food group was that this is a subject that does not require a strict licensing ar-rangement by the [FDA]"); id. at 91 (supporting a "provision to the effect that after an unfavorable opinion by the Secretary the proponent may not use the additive without first giving to the Secretary at least 30 days notice of intended use, which would enable the Secretary to institute any type of legal action which he deems advisable").
58. 1957 Hearings, supra note 22, at 21 (letter from M.B. Folsom, Secretary, HEW) ("Moreover, as the bill is drawn, the requirement to notify us of an intended shipment would apply only to the person submitting the pretesting data, and our adverse evaluation would not legally operate to prevent shipment by others.").
59. See H.R. 6747, 85th Cong. § 5 (1957); 1957 Hearings, supra note 22, at 28-36 (letter and memorandum from M.B. Folsom, Secretary, HEW).
60. See H.R. 6747, 85th Cong. § 5 (1957); 1957 Hearings, supra note 22, at 28-36 (letter and memorandum from M.B. Folsom, Secretary, HEW).
61. See 1957 Hearings, supra note 22, at 447 (statement of George P. Larrick, Comm'r, FDA). Commissioner Larrick stated: When issued, the regulation would give all food manufacturers who might wish to use a new chemical in their foods official assurance that its safety has been established under the precise conditions set out in the regulation; the regulation would be a rule for all to follow, not a license to a single manufacturer. Id.; see also id. at 423 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("[S]uch determinations should have the maximum possible future value in regulating the use of the substance . . . [by] prescribing conditions for its use by all others in the same segment of the food industry."); cf. id. at 141 (testimony of Lawrence A. Coleman, appearing on behalf of the Mfg. Chemists' Ass'n) (declining to take a position on the relative merits of licensing for an individual applicant rather than issuing a generally-applicable regulation).
62. See 1957 Hearings, supra note 22, at 447 (statement of George P. Larrick, Comm'r, FDA). Commissioner Larrick stated: When issued, the regulation would give all food manufacturers who might wish to use a new chemical in their foods official assurance that its safety has been established under the precise conditions set out in the regulation; the regulation would be a rule for all to follow, not a license to a single manufacturer. Id.; see also id. at 423 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("[S]uch determinations should have the maximum possible future value in regulating the use of the substance . . . [by] prescribing conditions for its use by all others in the same segment of the food industry."); cf. id. at 141 (testimony of Lawrence A. Coleman, appearing on behalf of the Mfg. Chemists' Ass'n) (declining to take a position on the relative merits of licensing for an individual applicant rather than issuing a generally-applicable regulation).
63. See 1957 Hearings, supra note 22, at 447 (statement of George P. Larrick, Comm'r, FDA). Commissioner Larrick stated: When issued, the regulation would give all food manufacturers who might wish to use a new chemical in their foods official assurance that its safety has been established under the precise conditions set out in the regulation; the regulation would be a rule for all to follow, not a license to a single manufacturer. Id.; see also id. at 423 (statement of Elliot L. Richardson, Asst. Secretary, HEW) ("[S]uch determinations should have the maximum possible future value in regulating the use of the substance . . . [by] prescribing conditions for its use by all others in the same segment of the food industry."); cf. id. at 141 (testimony of Lawrence A. Coleman, appearing on behalf of the Mfg. Chemists' Ass'n) (declining to take a position on the relative merits of licensing for an individual applicant rather than issuing a generally-applicable regulation).
64. See H.R. 2245, 83d Cong. § 6 (407(d)) (1953). Such a passive approval approach resembled that used by the FDA for new drug approvals before passage of the Drug Amendments of 1962.
65. See H.R. 10,404, 85th Cong. § 5 (409(e)) (1958); see also H.R. 8390, 85th Cong. § 5 (409(f)) (1957) (requiring notification 90 days before use); H.R. 7607, 84th Cong. § 5 (409(e)) (1955).
66. As HEW explained: We believe that the time limit which the bills would allow for initial action by the Secretary should be extended to 120 days, with authority to the Secretary to extend it to 180 days when found necessary . . . . Consideration of the adequacy of testing of additives will be no less difficult and time consuming than passing on a new-drug application. 1956 Hearings, supra note 16, at 141 (HEW memorandum).
67. Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified as amended in scattered sections of 21 U.S.C.). The bill passed unanimously in the House of Representatives. See, e.g., 104 CONG. REC. 19,359 (1958) (statement of Sen. Hill).
68. See S. REP. NO. 85-2422, at 2 (1958) ("[T]he processor who wants to add a new and unproven additive [must] accept the responsibility now voluntarily borne by all responsible food processors of first proving it to be safe for ingestion by human beings."). As one commentator explained, "[o]ften this allocation of the burden of proof determines substantive outcomes." Peter Huber, The Old-New Division in Risk Regulation, 69 VA. L. REV. 1025, 1034 (1983) ("Even when the substantive standard for acceptability is the same in the two systems, some sources of hazard will be excluded under the screening system, but tolerated under the standard-setting one because degrees of hazard can never be evaluated with absolute precision."). In addition, the cost of acquiring necessary information and the risks associated with delay are shouldered by the regulated entity rather than the agency under a screening system. See id. at 1034-36.
69. See S. REP. NO. 85-2422, at 2 (1958) ("[T]he processor who wants to add a new and unproven additive [must] accept the responsibility now voluntarily borne by all responsible food processors of first proving it to be safe for ingestion by human beings."). As one commentator explained, "[o]ften this allocation of the burden of proof determines substantive outcomes." Peter Huber, The Old-New Division in Risk Regulation, 69 VA. L. REV. 1025, 1034 (1983) ("Even when the substantive standard for acceptability is the same in the two systems, some sources of hazard will be excluded under the screening system, but tolerated under the standard-setting one because degrees of hazard can never be evaluated with absolute precision."). In addition, the cost of acquiring necessary information and the risks associated with delay are shouldered by the regulated entity rather than the agency under a screening system. See id. at 1034-36.