LG-*8B4 REV 10-63 ESTULlSHED WOZ E. I. du Pont de Nemours & Company INCORPORATED Wilmington, Delaware 19898 , LEGAL DEPARTMENT mreh 16 1970 Mr. Morgan M. Hoover, Secretary Pood, Drug, and Cosmetic Chemicals Camilttee Manufacturing Chemists Association 102|5 Connecticut Avenue, S. V. Washington, D. C. 20009 Daar Morgani Aa proalaad par phorva last Friday, I have glvan soM thought to tha drafting question which should sn^ up this natter. As a frame of rafaranca, Z should point out that la , addition to tha quo tad sac t ions of tha Delaney Act In tha draft statement, thara is a furthar proviso expressly axsaptlng food for an Inals ralsad for food production mars no rsslduss of an additive ara found in adibla portions, tha full proviso tharafor roods ss follows i Provided, That no addltlva shall ba rlssat 1 to be safe if it Is found to Indues canear when lngastad by asn or animal, or if it is found, aftar taats which ara approprlata for tha evaluation of tha safety of food additives, te Induce cancer in nan or anlaal, sxaspt that this proviso shall not apply with reepeet to tha use of a substanas as an Ingredient of feed for anlaals ml ah ara raised for food iflan* If tha Secretary finds (1) that, ltd fjndltlens of asa and feeding spool* InjMIHNaad labeling and reasonably eerm Jm fallowed In practice, such addltlva Wt hdiai sal j affaat tha animals for miah ___ fgpd id Intended, and (11) that no residua of tha additive will bo found (by Methods of examination prescribed or approved by tha Secretary by regulations, which redactions shall not ba subject to subsections (f) and (g)) in any edible portion of such anlnal after slaughter or In any food yielded by or derived free the living animal;" ASI 00002398 Mr. Bergen ft* - 2 - )tor«h 16, 1970 Apart fro* the question of drafting technique, tho first questlea to to itolvsd Is whether our proposed proviso should go before or after the enlmal feed exemption uhleh I recall was ob­ tained by the Animal Health Institute as a result of substantial legislative activity, frankly, X concur with Ken Halford's position that the proviso should probably eons before the anlnal feed exemp­ tion, and X think this can be done without disturbing the Anlnal Ssalth Institute position. After the words "to induoe denser in nan or animal"- wo would add tho following "axeapt that the foregoing provisions of this proviso shall not apply where In the opinion of tho Secretary sufficient evidence exists to permit establishment of e safe or toxicologically insignificant level of Intake for wen of suaM substances so found to induoo cancer; and exempt, further, that foregoing provisions of this proviso shall not apply", etc,, up the language in the Animal Health Institute exemption). Turning to the Color Additive Amendment, we have g stantlally similar problem though the language differs In minor respects. The Delaney Amendment language with respect t§V*r‘ color additives reads as follows* ‘ . t- "(B) A color additive (1) shell be deemed unsafe, and shall not be listed, for any use which will er may result la Ingestion of all or part of such additive. If the additive Is found by the Secretary to Induce censer when Ingested by men or animal, or If It Is found by the Secretary, after tests which are appro­ priate for the evaluation of the safety of additives for use In food, to ladnee eaaeer In men er animal, end (11) shall be deemed un­ safe, sad shall not to listed, for say us* which will met reeult In lngeetiea of any part ef such after tests which are appropriate itlon of tho safety of additives mirmf** after other relevant espoeure to Stomal to such additive, it Is found tojjstsry to Induce cancer In men or h (•) shall not apply with respect to the use ef a color additive as an Ingredient of feed for animals which are raised for feed production, if the Secretary finds that, under the conditions ef see and feeding specified in proposed labeling and reasonably certain to be ASI 00002399 V Hr. March 16 - 3 - 1970 fullswed lnpracticc, such additive in 11 not ndvtVPPly effect tho tnlmli for which such food Is intended, snd that no residue of tho additive will bo found (by methods of sxasdnstion prescribed or approrod by tho 80crotary by regulation*, which regulation* Khali not bo subject to subsection (d)) in any odlblo por­ tion of such anInals after slaughter or in any food yielded by or derired froa the living aninal." Again, X would suggest that our proviso precede the anitxeeption. Beginning with the words “Provided, That", it would read Provided, That clauses (1} and (ii) of this subperagra (») shall not apply where in the opinion of the Seerotary, Hi,)1, The Aninal Health Institute exception could then follow with Ml "and provided, further," type lead-in. Nawever, this exe^tdUn should still be Halted to clause (1) of subparagraph (1) JMtgS it la now so United in the statute An anendnent siailar to the language end approach pg -have suggested for food addltlrca would also be needed for Mtettlg 512(d)(1)(H) of the new aninal drug section of the Act added by the Animal Drug Aaendnents of 1968. In answer to Sen Nulford's guestion In the last paragraph of his March 9 letter to ae and for the record eo that there will be no alsunderstanding aaoag those receiving a carbon copy of that letter, it is our intention that MBA's legislative liaison nan, a Mr. Morgan, will arrange an Infernal nesting with Nr. Creed Black of HUT, who had infernally related Flash's lafulry to MCA. Morgan will orally pass on the substance of MBA's views snd st ths sons tins provide a copy ef the statenant. It is understood, of courts, that whils MCA has been asked in confidence by HM to provide our views, if any, and while it is expected that any MBA views trans­ mitted te Mp will Bp naintainsd aa confidential, there Is no way to ptesfaMf MM f*PM disclosing any part of er releasing the sta te­ nant tg MM Ip SHp Spares that night suit its purpose. •••• ’ . ■ >■ -■ ■- Sincerely, v -t Taylo Sanavan TVHicna cet J. ?. Frawley V. A. Khapp X. M. Miller K. X. Mulford J. A. Zapp, Jr. ASI 00002400