Document jBk3OXw9wK1ze2Z4nEm6JDGgy

DRAFT - TWH 2/9/70 Section 409(c)(3) states that "No such regulation shall issue if a fair evaluation of the data before the Secretary - (A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe." There follows a proviso, the so-called Delaney Amendment, which states. "Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of food additives, to induce cancer in man or animal;..." ? * ' Other than the recent application by FDA of the Delaney Amendment to cyclamates, the Amendment has not been (much ofjj a ^[^\^eir^o^industryl since its enactment in 1959* To date, the term "cancer" as used in the Amendment has been limited toAtumors /that metastasize (malignancies)/and the mere presence off'benTgji growths) has not resulted in application of the Amendment. Moreover, in spite of the efforts of various scientific groups including a special FDA advisory committee, no (specialty pro tocols for mincer testing ha been devised. As a result,^nojsuch protocol* h(Mben (tequlre^ by FDA as part of the safety evaluation of(an)new additive.? The lack of significantburden on Industryj to date does not mean that the Delaney Amendment could not in the futurej[resuit ASI 00002424 IV ) Draft 2 2/9/70 in the imposition on industry of; an unrealistic insurmountable burden which could pose a serious threat to the development of new products rthat would contribute to food technology andVe bene ficial tojthe food supply. The Act could be construed to include within the term "cancer" anyjgrowth regardless of Trialignancjr. New protocols may be proposed which go beyond what is scientifically reasonable and the economic parameters of new product development. Most significant, however, is that with today's analytical proce dures, almost any substance in some quantity is capable of detec tion by highly refined analytical equipment and methods sensitive to parts per billion and even parts per trillion. Coupled with this is the fact that our biological scientists have developed unique toxicological testing techniques that given the right species, dosage form, timing and method of administration, almost any substance can be found to induce a tumor of some type whether benign or malignant - a result which, however meaningless, might require the Secretary to refuse[to approve or ban the additive A involved. The Act as presently constituted imposes a per se con cept so that the Secretary by statute is precluded with respect to cancer from exercising any reasonable scientific Judgment on the question of toxicologically significant hazard or risk to man. Yet the legislative history of the Act and experiences thereunder demonstrate the [ii^ade^uac^j of a per se approach to a scientific ASI 00002425 Draft -3- 2/9/70 question of this type. Mtfe need only point out in this regard thatv _ '( * w> Ithe 1938 Act in effect imposed a per se concept.^ A substance (once"' found harmful or deleterious at some level wasniarre'd at any level df use. However, experience over the years demonstrated that such a nonscientific approach was unreasonable and unnecessary. With the Pood Additives Amendment of 1953, Congress recognized the need jC, r .t>1 for reasonable scientific judgment in "this area} by authorizing the Secretary to establish safe limits of a substance for man even where such substance was found to cause in animals a chronic or acute toxic response at a higher level or levels. Yet in 1953, Congress by the Delaney Amendment also at the last moment] reim- unworkable J>y past experience and again demonstrated to be unwork able by the recent cyclamate experience.) (_This is not to say th^jj elimination of the Delaney Amendment automatically would, authorize the Secretary to set tolerances for carcinogens. Naturally, before any such tolerance could be established, jttat^s with any other toxic effect^the Secretary ae~a matter of scientific judgment would have to con clude from the scientific evidence available whether a threshold limit could be established for a suspected carcinogen. _ln this regard, with few lere is fairly--,g1 eneral agreement that at least in some cases it may be] possible to set such thresh old limits. Yet the Delaney Amendment as phrased precludes any ASI 00002426 Draft -4- 2/9/70 scientific judgment - the same scientific judgment which Congress entrusted to the Secretary for the safeguarding of the public health with respect to all other toxlci4y problems pertinent- to food additives. -s ,, J^ptually^./there is no reasonable justification for con tinuing the Delaney Amendment in any form. However, it would be difficult from a legislative enactability point of view to accom plish outright ifipjpeal. For this reason, it is suggested that the Amendment be revised to restore to the Secretary the right and obligation of exercising scientific Judgment in the area of car- cinogenicity. To this effect, we would suggest that the semicolon7 and the word "or" be deleted from the last sentence of the so- called Delaney Amendment and the following language added: "...unless in the opinion of the Secretary sufficient evidence exists to permit estab lishment of a safe or toxicologically`insig nificant level of intake for man of such substance so found to induce cancer." ASi 002427