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A Legislative History of the Pesticide Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958 BRUCE S. WILSON STATEMENT OF PROBLEMS Section 402 of the Food, Drug and Cosmetic Act (FDC Act) includes a "flow-through" provision under which approval of a tolerance for pesti- cide residue in a raw agricultural commodity under the terms of section 408 serves as substitute approval of the residue in processed food under section 409. If the concentration of the residue in the processed food is still below section 408 tolerances, then no independent section 409 approval is required. The standards for approval under sections 408 and 409 are markedly different, however. Section 408 uses a type of risk/benefit balancing- weighing the need for an adequate food supply against the need to protect the consumer's health. Section 409 includes the "Delaney Clause," which flatly prohibits approval of a food additive found to induce cancer in humans or animals. The combination of the section 402 "flow-through" provision and the different standards in sections 408 and 409 creates an anomalous situation whereby a potentially carcinogenic pesticide residue can become a lawful additive to food in spite of the Delaney Clause. As long as the residue does not exceed the section 408 tolerance, the pesticide need not meet the more exacting Delaney standard found in section 409. This anomaly has become increasingly significant in recent years, because some previously approved pesticides have proved carcinogenic in animal studies. 161

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62 APPENDIX A QUESTION PRESENTED Was Congress aware of the implications of the different approval standards in sections 408 and 409? CONCLUSION Three factors in the legislative history appear to have a bearing on the anomaly created by the relationship between the Delaney Clause and the section 402 "flow-through" provision. First, Congress dealt separately, both conceptually and chronologically, with food additives and pesticide residues. In considering the 1958 Food Additives Amendments, Congress appeared anxious to avoid reopening the pesticide residues debate settled in the 1954 Pesticide Residues Amendments. Hence, bill drafters and witnesses at hearings universally limited, or even precluded, applicability of the proposed food additive standards to pesticide residues. Congress appeared willing to accept this conceptual distinction be- tween consideration of supposedly nontoxic substances (intentionally added to food during processing), and consideration of residues from highly toxic pesticides. Congress readily accepted the necessity of using at least some pesticides to maintain an adequate food supply. In contrast, hearing testimony during consideration of the food additives legislation reveals a perception that many food additives were optional, applied either to make food appear more appealing or to provide some other marketing advantage for the food processor. Hence, this factor suggests that Congress did not view separate treatment as presenting a significant inconsistency. A second factor suggests that Congress may have simply missed the inconsistency between the standards. This factor is the unique procedure used in the enactment of the Delaney Clause. As reported by the House Committee on Interstate and Foreign Commerce, the Food Additive Amendment did not include a Delaney Clause. However, the committee apparently wanted the support of Congressman James Delaney (D-N.Y.) badly enough to make a significant last-minute amendment to the bill. Subsequent to the publication of the report on the bill produced in committee, Congressman Delaney convinced the committee to adopt an amendment inserting his carcinogens clause into the new section 409 approval standard. The haste with which the committee added this amendment probably obscured both the contrast that the clause provided to the section 408 standard and the anomaly potentially created by the "flow-through" provision. Finally, the FDA's own position on the food additive and pesticide residues legislation helps to explain the presence of the potentially

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LEGISLATIVE HISTORY i63 inconsistent provisions. Shortly after passage of the 1954 Pesticide Residues Amendments, the FDA promulgated a regulation providing for automatic section 406 approval of pesticide residues remaining in pro- cessed food. Whenever the remaining residues did not exceed the section 408 tolerances for raw commodities, the FDA would approve the residues under the then-applicable criteria of section 406. When food additive legislation was later proposed, the FDA modified this regulation into the present statutory "flow-through" provision applicable to section 409. Hence, in the case of pesticide residues in processed food, the FDA had already substituted the more flexible risk/benefit standard embodied in section 408 for the "required" or "unavoidable" standard of section 406. These circumstances suggest that the FDA believed, or succeeded in convincing Congress, that the more flexible standard contained in section 408 adequately addressed the pesticides issue even in the case of residues in processed food. These factors the separate consideration of pesticides and food addi- tives legislation, the last-minute inclusion of the Delaney Clause, and the FDA's desire to use a risk/benefit standard whenever dealing with pesticide residues all suggest that Congress was not overly concerned by the potential anomaly created by the distinctions between sections 408 and 409. The different standards resulted primarily from Congress' willingness to view pesticide issues as distinct from food additive con- cerns. Accordingly, the "anomaly" was, to the members who discerned it, not particularly striking. The addition of the Delaney Clause sharpened the contrast between the provisions, but most likely was the product of a necessary compromise between the different standards for food additives advocated by the FDA and by Congressman Delaney. DISCUSSION OF AUTHORITY The Delaney Committee Report On June 30, 1952, the House Select Committee to Investigate the Use of Chemicals in Foods and Cosmetics (Delaney Committee) culminated its two-year investigation into the "nature, extent and effect of the use of chemicals" in food and food production. The committee recommended that the House pass legislation to control the flow of chemical substances into the nation's food supply. Chairman Delaney included in the report testimony from the National Cancer Institute (NCI). The testimony noted that "a large number of chemical compounds induce cancer in animals," and concluded that "any estimate of the possible injurious properties of chemicals added to nutrients consumed by men should include careful testimony for their carcinogenic properties in several species of animals

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~ 64 APPENDIX A prior to approving their use in food."2 The committee report also criticized existing legislation directed at pesticide residue control, and concluded that new, more effective legislation was necessary.3 The discussion of pesticides and food additives in that report presaged the later development of the different standards used in two distinct pieces of legislation, the Pesticide Residues Amendments of 1954 and the Food Additives Amendments of 1958.4 The committee report noted that some witnesses had advocated separate treatment for agricultural pesti- cides and those "chemicals which are added to a food product after harvesting."5 However, the report took the position that the presence of pesticide residues even in processed food warranted strict scrutiny of potential hazards.5 The report concluded that questions "regarding [the long- and short-term health effects of] any alien material which may find its way, in any amount, into our food supply" had to be answered to ensure the continued health of the nation (emphasis added).5 Although this language appears to advocate a single strict standard for pesticide residues and food additives, the report did note the committee's belief "that with proper care, and by taking reasonable precautions, it is possible to utilize the poisonous properties of Epesticide] chemicals in destroying insects and controlling diseases which attack many crops, without endangering the health of the people who consume the prod- ucts."5 Hence, the Delaney Committee's own report language exposes some tension between the desire for absolute safety in the use of chemicals and the recognition that highly toxic pesticides play a neces- sary role in the maintenance of the nation's food supply. The assumption that most pesticides could be used without significantly endangering health resolved this tension. However, under a standard like the Delaney Clause, or one as strict as that implied by the Delaney Committee report, few pesticides would receive approval. Recognizing this underlying problem, the minority report submitted by Congressman Thomas G. Abernethy (D-Miss.) recommended separate treatment for pesticides and food additives.6 The distinction suggested by Congressman Abernethy between pesticides and food additives was founded on the perceived distinction between the nature of their use. "Their [pesticides'] use is from necessity and not by choice."7 Abernethy's distinction may lack strong factual support, but it has an intuitive appeal that may partially explain the subsequent enactment of apparently inconsistent provisions. If agricultural interest successfully characterized pesticides as "necessary" to the preservation of the nation's food supply, while food processing interests failed to dispel completely the perception that many food additives were optional (for example, used for marketing enhancement or cost savings for the manu- facturer), then the distinction in the standards seems less surprising.

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rEGISrATIVE HISTORY ~65 The Pesticide Residues Amendments In response to the Delaney Committee report, a number of members introduced bills at the beginning of the 83d Congress designed to address the concern over pesticides. Congressman A. L. Miller (R-Neb.), one of the members of the former Delaney Committee, introduced H. No. 4277, 83d Cong., 1st sees., reprinted in XII Legislative History at 546. The Miller bill, which eventually became the Pesticide Residues Amendments of 1954,8 included standards under which the FDA commissioner would evaluate pesticide chemicals. The commissioner was to establish toler- ances "to the extent necessary to protect the public health."9 Signifi- cantly, the bill also directed the commissioner to "give appropriate consideration to the necessity for the production of an adequate and wholesome food supply."9 During House hearings on Congressman Miller's bill and on the clean bill (which incorporated the changes made at a committee "mark-up") subsequently reported by the Committee on Interstate and Foreign Commerce, A the risk/benefit balancing standard took on its present form. The final version of the bill included various factors to be considered in establishing pesticide residue tolerances. In his own analysis of the final bill, Congressman Miller noted that the factors were specifically "designed to assure a proper balance between the need for protecting the consumer from unsafe pesticide chemicals in or on food, and the need for assuring an adequate, wholesome, and economical food supply." Miller's risk/benefit balancing standard had found support from a number of groups interested in the legislation. Agricultural interests,~3 the pesticides industry,'4 and the FRAY all appeared comfortable with the balancing standard. Indeed, Congressman Miller claimed universal support for the legislation. The House report on the committee bill clearly described the balancing of factors employed in establishing pesticide tolerances.~7 Significantly, the report also includes a disclaimer regarding pesticide residues in processed food: "ET]his bill does not attempt to regulate the residue from pesticide chemicals which may remain in or on processed, fabricated, or manufactured food. . . . " ~8 The bill passed without debate in the House,~9 and after brief consideration before the Senate Committee on Labor and Public Welfare, 20 the Senate also passed the bill.2i The Food Additives Amendment During the same Congress, members introduced a number of bills purporting to deal with food additive s.22 The later bills, introduced after May 1954, accounted for the new pesticide legislation by exempting

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i66 APPENDIX A pesticide residues on raw agricultural products in the definition of food additives. 1956 HEARINGS The House Interstate and Foreign Commerce Committee first held hearings on the proposed food additives legislation during the early part of 1956.23 These early hearings, although less extensive than those held during the subsequent Congress, contained some significant testimony with respect to the interaction between sections 408 and 409. First, the National Agricultural Chemicals Association suggested an amendment to the proposed bills that would have totally excluded pesticide chemicals from the definition of food additives.24 The effect of this definitional change was to avoid subjecting pesticide residues, either on raw or in processed foods, to the new section 409 standards. The executive secretary of the association, Leo S. Hitchner, observed that such a definitional exclusion merely maintained the status quo with respect to pesticide residues remaining in processed food (which were not covered by section 4081. Subsequent to passage of the Pesticide Residues Amendments, the FDA adopted a regulation that provided for automatic approval (for purposes of sections 402 and 406) of pesticides for which section 408 tolerances had been established.25 Hence, in the absence of specific food additives legislation, the FDA has already adopted, by regulation, the section 408 "flow-through" provision for section 406 approval of pesticide residues in processed food. FDA officials testifying before the subcommittee surprisingly made no reference to the existing "flow-through" regulation, nor did they advo- cate exemption of pesticide residues in processed food from the scope of the proposed additives legislation. To the contrary, Sunkist Growers Cooperative was the first to suggest, on the record, legislation containing the combination of both a broad definition of food additives (that is, including pesticide residues in processed food), and a "flow-through" provision granting section 409 approval where the residues remaining in processed food did not exceed section 408 tolerances.26 Why the FDA ignored the "flow-through" issue in its own testimony is not altogether clear. The bills before the subcommittee all clearly in- cluded in the definition of food additives any pesticide residues remaining in processed food. These bills, therefore, would have vitiated the existing "flow-through" regulation. Even though the various bills contained standards less exacting than the subsequently enacted Delaney Clause, the standards were generally stricter than those for section 408 toler- ances. These stricter standards may have required the FDA to reevaluate pesticide residues in processed food.

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LEGISLATIVE HIS TOR Y i67 1958 HEARINGS Whatever the reason for the FDA silence in 1956, circumstances apparently changed, and a "flow-through" provision appeared in legisla- tion introduced on behalf of the FDA in the following year. H. No. 6747, the U.S. Department of Health, Education, and Welfare's (HEW) own draft,27 along with a number of the other new bills considered in the committee, included legislative versions of the "flow-through" regulation being applied to proposed section 409.28 Obviously, interest in and support for the "flow-through" provision had increased considerably since the 1956 hearings. The FDA may have assumed that passage of food additives legislation in 1956 was unlikely, and so avoided submitting a bill of its own or discussing more technical provisions in which it had an interest. In any case, circumstances changed between 1956 and 1958. By 1958, HEW had submitted a complete draft of the bill, and the secretary was defending the "flow-through" provision as a measure "in consonance with a regulation now in force."29 This change in the department's approach to the legislation may have been in response to growing momentum behind the strictest approval standards, as exemplified in the bills authored by Congressman Delaney. Congressman Delaney's bill did not include a "flow-through" provision.30 As in the bills proposed during the latter session of the 84th and in the 85th Congress, Delaney's definition of food additives excluded pesticide residues on raw agricultural products. By negative implication, the definition thereby included pesticide residues remaining in processed foods. However, Delaney's bill, H. 7798, also included the provision regarding carcinogens, now known as the Delaney Clause.3~ The FDA opposed the Delaney Clause. H. No. 6747 actually provided for a relaxation of existing law through a "functional value" provision. The "functional value" standard did not require that the additive be absolutely necessary to production before approval could be granted.32 Citing consumer correspondence in the FDA files, FDA's assistant general counsel argued that consumers supported "the rational use of chemicals" in food processing.33 Rational use could include the employ- ment of certain poisonous chemicals as long as "there . . . twas] a good reason for the addition of the chemical and . . . fits presence] in the diet . . . twas] safe."33 The Delaney Clause quite obviously conflicts with this approach, because it establishes a per se rule prohibiting approval of carcinogens in even the most minute concentrations. The FDA did not couch its opposition to the bill in terms of an objection to a per se rule. Rather, the agency objected by claiming that the Delaney Clause unnecessarily singled out cancer production for specific men- tion.34 The FDA claimed that its own version of the legislation without the

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~ 68 APPENDIX A Delaney Clause still prohibited "the use of an additive unless it is established that Ethe additive] is without hazard to health."35 In addition to the FDA's opposition to a rigid standard, a conceptual distinction between pesticides and food additives contributed to the committee's development of distinct approval standards. In contrast to the generally accepted view that farmers had to use some toxic pesticides, testimony regarding food additives occasionally reflected a view that many potentially toxic chemicals were added to processed food without sufficient justification.36 This distinction between the perceived value, to the nation's food supply, of pesticides and other food additives was further enhanced by the existence of legislation already addressing pesticides. Witnesses often gave the impression that the control of pesticide residues on raw agricultural commodities constituted a sufficient response to the entire pesticide residues issue. In testimony before the House Health and Science Subcommittee, Congressman Miller, a member of the original Delaney Committee and primary sponsor of the Pesticide Residues Amendments, opined that "Congress intended to regulate the pesticide chemicals entirely separate [sic] and apart from the so-called food additive amendment. The pesticide chemicals are now classified and regulated. The public is protected."37 Miller added, "If people follow the directions in the use of different pesticides in the development of food, the amount [getting into processed food] is small, very small, and I think not harmful to the food supply, and that is protected now by the Agriculture Department and Food and Drug Administration."38 Accordingly, Miller's bill (H. No. 8112) included a "flow-through" provision.39 Agricultural interests also supported the distinction between pesticide residues and other chemicals in food. The National Agricultural Chemi- cals Association reiterated the position it took during the 1956 hearings, claiming that the pesticide "legislation already enacted assures the public of a safe food supply insofar as the use of agricultural pesticides is concerned. It eliminates the need of any further regulation of these products."40 Given the FDA's underlying objection to the Delaney provision, the concurrent enactment of the "flow-through" provision for pesticide residues is not surprising. The FDA successfully capitalized on the conceptual distinction raised by agricultural interests and certain mem- bers of Congress between "necessary" pesticides already addressed by the 1954 amendments and "optional" food additives. The "flow-through" provision, therefore, had four sources of political momentum: (1) The FDA's own support for the provision, (2) support from influential members such as Congressman Miller, (3) an implicit distinction between "necessary" pesticides and "optional" food addi-

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rEGISrATIVE HISTORY ~69 fives, and (4) the insistence by the agricultural lobby that the pesticides issue had been fully resolved by the 1954 amendments. These factors combined to make the "flow-through" provision a palatable solution to the issue of pesticide residues in processed food. The addition of the Delaney Clause made that solution potentially more anomalous. The sparse legislative history regarding the Delaney Clause gives no indication that Congress noticed the effect that the addition of the Delaney Clause had on the "flow-through" provision. As discussed above, the FDA opposed the Delaney Clause and supported the more flexible overall standard. When the clause was added at the last minute, the FDA could hardly be expected to draw attention to the "loophole" for pesticide residues afforded by the "flow-through" . . provlslon. Little else in the legislative history indicates what Congress intended to accomplish in creating the anomalous combination. Witnesses advocating the Delaney Clause focused primarily on the argument that medical science could establish no safe dosage for carcinogenic substances.4~ However, some of the same witnesses expressed doubts regarding the reliability of tests on animals as a basis for concluding that a substance was carcinogenic when ingested by humans.42 Commissioner Larrick stated in the House hearings that the HEW-drafted bill "would prohibit the addition of any chemical additive to the food supply until adequate evidence . . . shows that it will not produce cancer in man under the conditions of use proposed Lemphasis added]."43 This statement of the FDA-proposed standard certainly does not appear as rigid as the Delaney Clause, but the FDA made no significant attempt to distinguish the two standards. The committee may have accepted the FDA's argument that the clause was redundant. Similarly, it may have rejected testimony regarding the impossibility of setting a safe dosage for carcinogens, and responded to doubts about the reliability of cancer tests on animals. In any event, the extensive hearing testimony eventually led to the markup and reporting of a bill without any Delaney Clause.44 ADDITION OF THE DELANEY CLAUSE Sometime between the publication of the House report on July 28, 1958, and floor consideration on August 13, 1958, Delaney convinced the committee to amend the bill to include the Delaney Clause. Congressman Oren Harris (D-Ark.), chairman of the House Interstate and Foreign Commerce Committee, managed the bill on the floor. He inserted into the Congressional Record a letter from HEW Assistant Secretary Elliot

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{70 APPENDIX A Richardson. In that letter, Richardson withdrew the department's objec- tions to the Delaney Clause with the following statement: To single out one class of diseases for special mention would be anomalous and could be misinterpreted. Hence, in drafting the Department's bill, (H.R. 6747) we chose general language that would restrain any use of an additive that would have any adverse effect on public health.... At the same time, if it would serve to allay any lingering apprehension on the part of those who desire any explicit statutory mandate on this point, the Department would interpose no objection to appropriate mention of cancer in food additives legislation.45 Richardson's letter then suggested a slightly modified version of the clause proposed by Delaney in the committee hearings.46 The modified version became the committee amendment. Chairman Harris's own prepared remarks reflect the haste with which the committee approved the amendment. In his prepared analysis of the principal provisions in the bill, Chairman Harris describes the operation of the approval standards in the bill as reported, rather than as amended by the Delaney Clause.47 Congressman Delaney, after noting his "deep disappointment" that the bill reported from the committee contained no specific carcinogen prohibition, observed that "prolonged consultation with representatives of the Food and Drug Administration" eventually resulted in the FDA's agreement to the modified clause. Only Congress- man Miller openly opposed the clause, noting that "it would be impossi- ble to administer."48 The House and Senate passed the bill by substantial margins. The procedure employed to insert the Delaney Clause into the House bill indicates that Delaney had substantial personal influence on the committee. His chairmanship of the 1950 Select Committee probably played a significant role in establishing this influence. Delaney's own bill did not include a "flow-through" clause,49 but since the primary deliber- ations concerning insertion of the Delaney Clause occurred off-the- record, it is impossible to determine whether Delaney recognized the anomalous relationship between the two clauses. This combination of factors FDA support for a flexible standard, and, consequently for the "flow-through" provision; congressional willingness to view pesticide residues and food additives as conceptually distinct issues; and the "ex parse" procedure by which the Delaney Clause became part of the House bill all combined to create an inconsistent approach to food additives approval in the case of pesticide residues. The first two factors suggest that Congress did not view the separate standards as presenting a particularly disturbing inconsistency. The third suggests that most members were either unaware of the inconsistency, or at least tolerated it as an accommodation to Congressman Delaney.

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LEGISLATIVE HISTORY 171 NOTES 1. H. Rept. No. 2356, 82d Cong., 2d sess. 1 (1952), reprinted in A Legislative History of the Federal Food, Drug and Cosmetic Act and Its Amendments 499 (hereinafter Legislative History). 2. XII Legislative History at 503. Here, as elsewhere in the legislative history, proponents of strict controls on cancer-inducing substances did not adequately address the connection between cancer induction in animals and cancer induction in humans. Although some witnesses opposed to a flat ban on carcinogenic substances observed that tolerances varied considerably between some species, Delaney and others support- ing his bill seemed to assume the connection. There was also no indication of a willingness to use a risk benefit or other standard that accounted for the potential benefits foregone by the ban of a given chemical. From this first report and throughout the legislative history of the Delaney Clause, proponents categorically assumed that a finding of carcinogenicity warranted a total ban of the substance from the food supply. 3. XII Legislative History at 520. 4. The Pesticide Residues Amendment of 1954, Pub. L. No. 83-518, ch. 559, 68 Stat. 511 [codified at 21 USC 346a (1981)]; and the Food Additives Amendments of 1958, Pub. L. No. 85-529, ch. 4, 72 Stat. 1785 [codified at 21 USC 348 (1981)], respectively. 5. XII Legislative History at 524. 6. H. Rept. No. 2356, pt. 2, 82d Cong., 2d sess. 5 (1952), reprinted in XII Legislative History at 539, 542. 7. XII Legislative History at 542. 8. See note 3, supra. 9. XII Legislative History at 548. 10. Federal Food, Drug and Cosmetic Act (Pesticides): Hearing on H. 4277 Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 83d Cong., 1st sess. (1953), reprinted in XII Legislative History at 577; and Federal Food, Drug and Cosmetic Act (Residues of Pesticide ChemicalsAgricultural Commodities: Hearing on H. 7175 Before the House Comm. on Interstate and Foreign Commerce, 83d Cong., 2d sess. (1954), reprinted in XII Legislative History at 770. 11. See 21 USC 346a(b) (1981). The factors included in the determination of that tolerance level '`necessary to protect the public health" are, "among other relevant factors," (a) "the necessity for the production of an adequate, wholesome, and economic food supply"; (b) "the other ways in which the consumer may be affected by the same pesticide chemical or by other related substances that are poisonous or deleterious"; and (c) an opinion submitted by the Secretary of Agriculture regarding the agricultural usefulness of the pesticide in question. 12. XII Legislative History at 787. 13. See, e.g., XII Legislative History at 592 (statement of Ernest Falk, Northwest Horticultural Council). 14. See, e.g., id. at 641 (statement of L. S. Hitchner, National Agricultural Chemicals Association). 15. See Residues of Pesticide Chemicals: Hearing on S. 2868 and H. 7125 Before the Subcomm. on Health of the Senate Comm. on Labor and Public Welfare, 83d Cong., 2d sess. 920 (1954) (statement of Dr. Charles Crawford, FDA commissioner), reprinted in XII Legislative History at 882. 16. XII Legislative History at 793. 17. See H. Rept. No. 1385, 83d Cong., 2d sess. 3 (1954), reprinted in XII Legislative History at 833, 835.

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i72 APPENDIX A 18. XII Legislative History at 838. 19. 100 Cong. Rec. H4604 (daily ed. April 5, 1954), reprinted in XII Legislative History at 858. See note 12, supra. 20. See Residues of Pesticide Chemicals: Hearing on S. 2868 and H. 7125 Before the Subcomm. on Health of the Senate Comm. on Labor and Public Welfare, 83d Cong., 2d Sess. (1954), reprinted in XII Legislative History at 882. Senate consideration adds nothing relevant to the legislative history with respect to this particular question, since witnesses essentially repeated earlier testimony given before the House committee. 21. 100 Cong. Rec. S9727 (daily ed. July 6, 1954), reprinted in XII Legislative History at 1028. The Senate added a minor amendment to the bill providing for fee charges for establishing tolerances under the new section. The House agreed to this amendment without debate. 100 Cong. Rec. H10095 (daily ed. July 8, 1954), reprinted in XII Legislative History at 1030. 22. The various bills from the 83d and 84th Congresses are reprinted in XII Legislative History at 349-510. 23. Federal Food, Drug and Cosmetic Act (Chemical Additives in Food): Hearings on H. 4475 and H. 8275 Before the Subcomm. on Health and Science of the House Comm. on Interstate and Foreign Commerce, 84th Cong., 2d sess. (1956), reprinted in XIII Legislative History at 510. 24. XIII Legislative History at 660. 25. 20 Fed. Reg. 750 (1955) [codified until repealed at 21 CFR 120.1(f) (1956)]. The regulation read: (f) Where raw agricultural commodities bearing residues that have been exempted from the requirement of a tolerance, or which are within a tolerance permitted under section 408 are used, the processed foods will not be considered unsafe within the meaning of section 406 if: (a) the poisonous or deleterious pesticide residues have been removed to the extent possible in good manufacturing practice; and (b) the concentration of the pesticide in the preserved or processed food when ready to eat is not greater than the tolerance permitted on the raw agricultural commodity. 26. XIII Legislative History at 751 (letter from M. J. McDonald, Sunkist Growers Cooperative). 27. See Food Additives: Hearings Before the Subcomm. on Health and Science of the House Comm. on Interstate and Foreign Commerce on Bills to Amend the Federal Food, Drug and Cosmetic Act with Respect to Chemical Additives in Food, 85th Cong., 1st sess. 28 (1958), reprinted in XIV Legislative History at 163, 169. 28. See, e.g., H. 6747, XIV Legislative History at 40; H. 8112, XIV Legislative History at 118; H. 8629, XIV Legislative History at 139. 29. XIV Legislative History at 203 (materials submitted by M. B. Folsom, secretary of HEW). 30. H. 7798, XIV Legislative History at 91. 31.Id.at91,95. 32. See XIV Legislative History at 610-615 (statement of George Larrick, FDA commis- sioner). 33. Id. at 615 (statement of William Goodrick, FDA general counsel). 34. Id. at 616 (statement of George Larrick, FDA commissioner). 35. Id. at 615. 36. See H. Rept. No. 2356, pt. 2, 82d Cong., 2d sess. 5 (1952), reprinted in XII Legislative History at 539, 542; XIV Legislative History at 412-422 (testimony of George Faunce,

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LEGISLATIVE HIS TOR Y 173 American Bakers Association); id. at 462 (statement of Mrs. R. I. C. Prout, Federation of Women's Clubs); but see id. at 329 (statement of Congressman Miller) (noting that certain food additives are essential to maintenance of the food supply). 37. XIV Legislative History at 318. 38. Id. at 325. 39. See id. at 118. See also XIV Legislative History at 322 (statement by Congressman Miller). Here, Miller indicated that pesticide residues in processed food should be controlled by food additives legislation. However, he also added in testimony that any pesticide should "be under strict supervision, as it is now in the Pesticide Act," and he saw that pesticide residues could effectively become food additives, but he believed that their control under the terms of the Pesticide Act was sufficient. But see id. at 325, in which Miller states, "[i]f there is any question about [pesticides] getting in [to processed food] then they ought to be subject to the same approval as any other additive in food." The "flow-through" provision in Miller's own bill would have exempted many pesti- cides from the additives standard. 40. XIV Legislative History at 277 (statement of L. S. Hitchner, National Agricultural Chemicals Association). 41. See, e.g., XIV Legislative History at 336, 366, 534. 42. See XVI Legislative History at 368-370, 516, 532-533, 539. 43. XIV Legislative History at 615-616. 44. See H. Rept. No. 2284, 85th Cong., 2d sess. 24 (1958), reprinted in XIV Legislative History at 822, 845. 45. 104 Cong. Rec. H17415 (daily ed. August 13, 1958), reprinted in XIV Legislative History at 869. 46. The modified language reflected the FDA's concern that the original language of the clause would "forbid the approval for use in food of any substance that causes any type of cancer in any test animal by any route of administration." 104 Cong. Rec. H17415 (daily ed. August 3, 1958), reprinted in XIV Legislative History at 869. 47. Id. at 870; see also id. at 873 (statement of Congressman Richard H. Poff (R-Va.)) (reflecting a similar omission). 48. Id. at 875. 49. H. 7798, 85th Cong., 1st sees., 103 Cong. Rec. H7918 (1957), reprinted in XIV Legislative History at 91.