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Appendix A: Legislative History of the Pesticide Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958
Pages 161-173

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From page 161...
... 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.
From page 162...
... 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.
From page 163...
... These factors the separate consideration of pesticides and food additives 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 concerns.
From page 164...
... .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 products."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 necessary role in the maintenance of the nation's food supply.
From page 165...
... 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 tolerances "to the extent necessary to protect the public health."9 Significantly, 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")
From page 166...
... 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
From page 167...
... 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.
From page 168...
... 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.
From page 169...
... 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.
From page 170...
... Delaney's own bill did not include a "flow-through" clause,49 but since the primary deliberations concerning insertion of the Delaney Clause occurred off-therecord, 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.
From page 171...
... ] ; and the Food Additives Amendments of 1958, Pub.
From page 172...
... 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)
From page 173...
... . Here, Miller indicated that pesticide residues in processed food should be controlled by food additives legislation.


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