-C FOOD ADDITI VES—EXTENSION OF TRANS ITIONA L PROVISIONS i GOVERNMENT » ' I Stor age . Xn f a f 7 3 /g H E A R IN G S BEFORE THE COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE s HOUSE OE REP RESEN TATIV ES O' ru EI GH TY -SE VE NT H CONGR ESS c FIR ST SESSIO N ru KSU LIBRARIES ON <0 H .R .3980 A BIL L TO AMEND TH E TRANS ITION AL PROV ISION S OF TII E ACT APPROV ED SEPT EMB ER 6, 1958, EN TIT LED “AN ACT TO PRO TEC T TH E PUB LIC HEAL TH BY AMENDING TH E FED ERA L FOOD, DRUG, AND COSMETIC ACT TO PR OH IBI T TH E USE IN FOOD OF ADDI TIVES WH ICH HAVE NOT BEEN ADEQUATELY TES TED TO EST ABL ISH TH EI R SAFETY ,” AND FOR OTHE R PURPOSES FEBRU ARY 28 AND MARCH 1, 1961 Pr int ed f or the use of the Comm ittee on In te rst at e and F ore ign Commorpo ? REFERENCE 1 LIBRARY DEPARTMENT U.S. GOVERNMENT PRINT ING OFFIC E 66738 WASHINGTON : 1961 I COMMIT TEE ON INTE RSTA TE AND FOREIG N COMMERCE O R E N H A R R IS , A rk a n s a s , C h a ir m a n J O H N B E L L W IL L IA M S , M is si ss ip p i J O H N B. B E N N E T T , M ic h ig a n P E T E R F . M AC K . J r .. Il li n o is W IL L IA M L. S P R IN G E R . Il li n o is K E N N E T H A. R O B E R T S , A la b a m a P A U L F . S C H E N C K , O hi o M O R G A N M. M O U L D E R , M is so u ri J . A R T H U R Y O U N G E R , C a li fo rn ia H A R L E Y O. ST A G G E R S , W e st V ir g in ia W IL L IA M H. A V ER Y . K a n s a s W A LTE R RO GERS, T exas H A R O L D It . C O L L IE R , Il li n o is S A M U E L N. F R IE D E L , M a ry la n d M IL T O N W. G L E N N , N ew J e r s e y J O H N J . F L Y N T , JR ., G e o rg ia SA M U E L L. D E V IN E , O hi o T O R B E R T H . M A C D O N A LD , M a s s a c h u s e tt s A N C H E R N E L S E N , M in n e s o ta G E O R G E M. R H O D E S , P e n n s y lv a n ia H A S T IN G S K E IT H , M a s s a c h u s e tt s J O H N JA R M A N , O k la h o m a W IL L A R D S. C U R T IN , P e n n s y lv a n ia L E O W . O B R IE N , Ne w Y or k A B N E R W. S IB A L , C o n n e c ti c u t J O H N E . M O SS , C a li fo rn ia V E R N O N W . TH O M SO N , W is c o n si n J O H N D. D IN G E L L , M ic h ig an J O E M. K IL G O R E , T e x a s P A U L G. R O G E R S, F lo r id a R O B E R T W. H E M P H IL L , S o u th C a ro li n a D A N R O S T E N K O W S K I, Il li n o is JA M E S C. H E A L E Y , N ew Y or k W . E. W il l ia m s o n , Cle rk K e n n e t h J . P a in t e r , A ss io fo n t Cle rk P ro fe ss io na l S ta ff A nd r ew S t e v e n s o n S am G. S ta l K ur t B o ii c h a r d t M a rt in W. C u n n in g h a m II CONTENTS Pa ge Tex t of H.R. 3980_______________________________________________ 1 Rep ort of He alth, Edu catio n, and Welfare De pa rtm en t________________ 2 Sta tem ent of— Boyd, George, J r., counsel, American Pap er & Pulp Associatio n_____ 26 Delaney, Hon. Jam es J., a Rep rese ntat ive in Congress from the Sta te of New Yor k______________________________________________ 7 Dunkelb erger, H. Edw ard, Jr., counsel, Nat ion al Canner s Associa­ tion ______________________________________________________ 41 Harvey , Joh n L., Dep uty Commissioner, Food and Drug Adminis­ trat ion ___________________________________________________ 11 King, Hon. Dav id S., a Rep rese ntati ve in Congress from the Sta te of Ut ah_____________________________________________________ 9 Larrick, George P., Commissioner, Food and Drug Ad mi nis tra tio n._ 11,37 Markel, Michael F., food, drug, and cosmetics section, New York Bar Associatio n______________ _________________________________ 44 Muldoon, Thom as J., techni cal direc tor, Nat iona l Paper board Association _______________________________________________ 29 Mulford, Ken neth E., chair man , food a ddit ives comm ittee, Manufa c­ turin g Che mist s’ Association, In c____________________________ 39 Ribicolf, Hon. Abrah am, Secre tary of Heal th, Edu catio n, and Welfa re. 11 Addit ional inform ation sub mit ted for t he record by—• Brid gev ater Homem akers Ciub, let ter from Josep hine P. Shively___ 47 Dixie Cup Division of American Can Co., l ett er from R. D. Pine, Jr., residen t couns el___________________________________________ 50 Dow Chemical Co., let ter from Russell A. Whitese ll, special assis tant to the pre sid ent ___________________________________________ 49 East man Chemical Produ cts, Inc., let ter from M.C. Stone, assis tant sec reta ry_________________________________________________ 48 Food and Drug Adm inist ratio n, lett er from George P. Larrick, Com­ missioner_________________________________________________ 37 Food Law I nst itu te, Inc., let ter from Fran klin M. Depew, pr es id en t.. 46 Nation al Cot ton Council of America, let ter from J. Banks Young___ 49 Nopco Chemical Co., lett er from Joh n N. Gammo n, vice pre side nt.. 47 hi FOOD ADDITIVES—EXTENSION OF TRANSITIONAL PROVISIONS T U E S D A Y , F E B R U A R Y 28 , 19 61 H ouse or R epr ese nta tiv es , C om mi tt ee on I nter stat e and F ore ign C omm erce . IF ashington, D.G. The committee met at 10:30 a.m., pur suan t to notice, in room 1334, New House Office Buildi ng, Hon. Oren Ha rris (chairman of tlie com­ mittee) presiding. The Chairman. The committee will come to order. Today the committee is meeting to conduct hearing s on H.R. 3980, a bill to provide for the cont inuation o f the a utho rity of the Secretary of Health, Education, and Welfar e to permit the commercial use of certain food additives and pesticide chemicals pen ding the outcome of investigations and scientific studies now in progress by both the industries concerned and the Food and Drug Admin istratio n to d eter­ mine, what, if any, tolerance limitatio ns or othe r conditions should be imposed on thei r use in order to protect the public health. The S ecretary ’s aut hori ty to permit the continued use of these food additives expires March 4, 1961, and with respect to the pesticide chemicals the expirati on da te is March 5,1961. I have introduc ed the bill at the request of the Secretary of H ealth, Education , and Welfa re and in view of the urgency which has been expressed as t o t he need f or its prompt enactment, I have scheduled hearings on t his bill as the first order of business o f the committee duri ng this session. A copy o f H.R. 3980, to gether with the departm ental and agency reports thereon, will be made a part of the record at th is point. (Documents referred to foll ow:) [I I. R . 39S0 , 87 th Co ng. , 1 st se ss. ] A B IL L To am en d th e tr a n si ti o n a l pr ov is io ns of th e A ct ap pr ov ed Se pt em be r 6. 195 8, en ti tl ed “A n Ac t to p ro te c t th e pu bl ic he al th by am en di ng th e F ed er al Fo od , D ru g, an d (' os m et ic Ac t to p ro h ib it th e us e in fo od of ad di ti ve s w hi ch ha ve n ot bee n ad eq uat el y te st ed to es ta bl is h th e ir sa fe ty ”, an d fo r o th er pu rp os es li e it en ac te d by th e S en a te and- H ou se of R ep re se n ta ti v e s of th e U ni ted S ta te s o f A m er ic a in C on yr es s as se mb le d, T h a t th is A ct m ay be c it ed a s th e “F oo d A dd i­ ti ve s T ra n si ti o n a l P ro vi si on s A m en dm en t o f 196 1” . S ec . 2. Su bs ec tio n (c ) of se ct io n G of th e Fo od A dd iti ve s A m en dm en t of 1938 (P ub li c La w 83 -92 9, 72 S ta t. 1784, 1788 ) is am en de d by in se rt in g in su ch su bs ec tio n, a t th e en d th er eo f th e fo ll o w in g : “W he ne ve r th e Se cre tar .v ha s, p u r­ su a n t to cl au se (1 ) (B ) of th is su bs ec tio n, ex te nd ed th e ef fe cti ve dat e of se ct io n 3 of th is A ct to M ar ch G. 1961, w it h re sp ec t to an y su ch p a rt ic u la r us e of a fo od ad di ti ve , he ma y. n o tw it h st an d in g th e p ar en th e ti c a l ti m e li m it at io n in th a t cl au se , fu rt h e r ex te nd su ch ef fe cti ve d a te u n d er th e a u th o ri ty of th a t cl au se (b u t su bj ec t to cl au se ( 2 ) ) w ith re sp ec t to su ch us e of th e ad d it iv e (o r a m or e li m it ed spe cifi ed us e o r us es th er eo f) if, in ad di to n to m ak in g th e fin di ng s re ­ q u ir ed by cl au se (1 ) (B ), he fin ds (i ) th a t bo na fide ac ti on to de te rm in e th e ap- 2 FOOD ADD ITIV ES pl ic ab il it y of s uc h se ct io n 409 to su ch us e o r us es , o r to d ev elo p th e s ci en tif ic d a ta ne ce ss ar y fo r ac ti on un d er su ch se ct io n, w as co mm en ce d by a n in te re st ed pe rso n be fo re M ar ch 6, 1900, an d w as th e re a ft e r pu rs ue d w it h re as on ab le d ili ge nc e, an d (i i) th a t in th e S ec re ta ry ’s ju d g m en t su ch ex te ns io n is co n si st en t w ith th e ob je ct iv e of c a rr y in g to co m pl eti on in goo d fa it h , as soon as re as on ab ly p ra c ti ­ ca ble , th e sc ie nt ifi c in ve st ig at io ns ne ce ss ar y as a ba si s fo r ac ti on u n d er su ch se ct io n 409. T he S ec re ta ry m ay a t an y ti m e te rm in a te an ex te ns io n so gra nte d if he fin ds th a t it sh ou ld not ha ve be en g ra n te d , o r th a t by re as on of a ch an ge in ci rc um st an ce s th e ba si s fo r su ch ex te ns io n no lo ng er ex is ts , o r th a t th e re ha s bee n a fa il u re to co mp ly w ith a re q u ir em en t fo r su bm iss io n of pr og re ss re po rt s or w ith o th e r co nd it io ns a tt a c h e d t o s uc h ex te ns io n. " S ec . 3. P a ra g ra p h (b ) of se ct io n 3 of th e N em ato cid e, P la n t R eg ul at or , D ef ol ia nt , an d D es ic ca nt A m en dm en t of 1959 (P ub li c La w 8(1-139, 73 S ta t. 286, 288 ) is am en de d by in se rt in g in su ch p a ra g ra p h , a t th e en d th er eo f, th e fo llo w ­ in g: “ W he ne ve r th e S ec re ta ry of H ea lt h, E du ca ti on , an d W el fa re h as p u rs u a n t to cl au se (1 ) of th is p a ra g ra p h (b ) , pre sc ri be d an ad di ti onal pe rio d ex pi ri ng on M ar ch 5, 1961, w it h re sp ec t to an y su ch p a rt ic u la r us e of a ne m at oc id e, pl an t re gu la to r, de fo li an t, or de si cc an t, he m ay , n otw it hst an din g th e pr ov is io n Io th e c o n tr a ry in su ch cl au se (1 ), fu r th e r ex te n d th e ex p ir at io n d at e ap pl ic ab le un de r su ch c la us e (1 ) (b u t su bj ec t to c la us e ( 2 ) ) w ith re sp ec t t o su ch us e o f su ch su bs ta nc e (o r a m or e lim it ed sp ec ifi ed us e o r us es th er eo f ,, if, in ad dit io n, t o m ak in g th e fin di ng s re qui re d by cl au se (1 ), he find s (A ) th a t bo na fid e ac tio n to de te rm in e th e ap pl ic ab il it y of su ch se ct io n 408 to su ch us e or use s, or to de ­ vel op th e sc ie nt ifi c d a ta ne ce ss ar y fo r ac ti on un der su ch se ct io n, w as co m­ me nc ed by an in te re st ed pe rs on be fo re M ar ch 6, 1960, an d w as th e re a ft e r p u r­ su ed w ith re as on ab le di lig en ce , an d (R ) th a t in th e S ec re ta ry ’s ju dg m en t su ch ex te ns io n is co nsi st en t w ith th e ob je ct iv e of c a rr y in g to co m pl et io n in good fa it h , a s soo n as re as on ab ly pra ct ic ab le , th e sc ien tif ic in ve st ig at io ns ne ce ss ar y as a ba si s fo r ac tio n un de r su ch se ct io n 408. T he Se cr et ar y m ay a t an y tim e te rm in a te an ex te ns io n so g ra n te d if he fin ds th a t it sh ou ld no t ha ve be en gr an te d, o r th a t by re as on of a ch an ge in ci rc um st an ce s th e ba si s fo r su ch e x te n ­ sio n no lo ng er ex is ts , o r th a t th e re li as be en a fa il u re to co mp ly w ith a re q u ir e­ ment. fo r su bm is si on of pr og re ss re p o rt s or w ith o th er c on di tio ns a tt ac h ed to su ch ex te ns io n. ” D epa rt me nt of H ea lt h , E duca tion , and W elfa re , Febr uary IM I. Ho n. O ren H ar ris . Chairma n, Co mmittee on Int ers tat e and Foreign Commerce, House o f Rep rese ntati ves. Washi ngton , D.C. D ear M r. C ha ir m an : T hi s is in re sp on se to y ou r re qu es t fo r a re po rt on II R . 3980. a bi ll to am en d th e tr a n si ti o n a l pr ov is io ns of th e ac t ap pr ov ed Se pt em be r 6, 1958. en ti tl ed “a n a c t to p ro te ct th e pu bl ic he al th by am en di ng th e Fe de ra l Fo od. D ru g, an d Co sm et ic Ac t to pro hi bi t th e us e in food of ad d it iv es wh ich ha ve n ot be en ad eq uat el y te st ed to es ta b li sh th e ir s af et y, " an d fo r oth er p ur po se s. T hi s m ea su re , to be kn ow n a s th e Fo od A dd iti ve s T ra n si ti o n a l P ro vi si on s A m en dm en t of 1961, w ou ld am en d e x is ti n g la w in two re sp ec ts . 1. T he pr in ci pa l pu rp os e of th is bil l, w hi ch wo uld be c a rr ie d out by se ct io n 2 of th e bil l, is to rem ov e— su b je ct to a p p ro p ri a te sa fe g u ar d s an d li m it at io n s— th e tim e li m it (M ar ch 6. 1961 ) w hi ch no w ex is ts on th e a u th o ri ty of th is De ­ p a rt m e n t to po stp on e, w he n ne ce ss ar y an d co nsi st en t w ith pu bl ic he al th pro te c­ tio n. th e ef fe ct iv e d a te of th e ke y o p er at iv e pr ov is io ns (se c. 3) of th e Foo d A dd iti ve s A m en dm en t of 1958 (P ub li c L aw 85 -92 9) to th e F ed er al Fo od, Dr ug , an d Co sm eti c Ac t. a s ap pl ie d to es ta bl is he d foo d ad di ti ve s (i. e., th os e in co m m er ­ ci al us e be fo re J a n u a ry 1. 1958 ). T he a ddi ti onal a u th o ri ty co nf er re d by th e bil l wo ul d ap pl y on ly w he re su ch fu r th e r po st po ne m en t be yo nd M ar ch 6, 1961, is ne ce ss ar y in ord er to ji er in it th e co m pl et io n of ne ce ss ar y in qu ir ie s or st udie s st a rt e d b ef or e M ar ch 6, 1960, an d ne ed ed as a ba si s fo r det er m in in g w he th er , an d if so u n d e r w h a t to le ra nc e li m it a ti o n s or o th e r co nd iti on s, co nt in ue d us e of th e ad dit iv e sh ou ld be pe rm it te d u n d e r th e p e rm a n e n t pr ov is io ns of P ub li c La w 85- 929 , or w h et h er th a t la w ap pl ie s to th e su bs ta nc e inv olv ed a t all . T hi s le gi sl at io n is ne ed ed , bo th by us, a n d by in du st ry , be ca us e we sh al l no t be ab le to pr oc es s al l fo od a d d it iv e p e ti ti o n s u n d er th e Fo od A dd iti ve s Am en d­ m en t of 1958— w he re ex te ns io ns hav e h er et o fo re be en g ra n te d —b ef or e M ar ch 6. 1961 (t h e li m it of o ur pre se n t a u th o ri ty to g ra n t ex te ns io n of th e tr a n si ti o n a l pr ov is io ns) , an d because th e af fe cte d in d u st ri e s wi ll no t lie ab le to de ve lo p al l FOOD ADD ITIV ES 3 ne ce ss ar y sc ie nt ifi c d a ta a n d p et it io n s be fo re th a t dat e, ev en w he re a p p ro p ri a te ac ti on le ad in g to s uc h p et it io n s w as st a rt e d i n a ti m el y m an ne r. 2. In or de r to m es h w it h th e ab ov e- m en tio ne d am en dm en t, th e bi ll (se c. 3) wo ul d si m il ar ly m od ify th e re le v an t tr a n si ti o n a l pr ov is io n of th e N em at oc id e. P la n t R eg ul at or , D ef ol ia nt , a n d D es ic ca nt A m en dm en t of 1939 ( P ub li c L aw 86- 139 , sec. 3 ( b ) ) , w hi ch , as th e in d ir ec t re s u lt of br in gi ng c e rt a in a g ri ­ c u lt u ra l ch em ic al s— i.e., ne m at oc id es , p la n t re g u la to rs , de fo lia nt s, an d de si c­ ca n ts —u nd er th e F e d e ra l In se ct ic id e, Fu ng ic id e, an d R od en ti ci de Ac t, had th e eff ec t of cl as si fy in g su ch ch em ic als , ab ou t 30 in nu m be r, a s “p es ti ci de ch em i­ c a ls ” un de r th e Fo od , D ru g, an d Co sm et ic Ac t, ra th e r th a n as “fo od ad d it iv e s. ” (P es ti ci de ch em ic al re si du es in o r on ra w a g ri c u lt u ra l co m m od iti es a re n o t w it h in th e pu rv ie w of th e Fo od A dd iti ve s A m en dm en t, b u t ra th e r w it h in th e pu rvi ew ’ of th e e a rl ie r P es ti ci de C he m ic al s A m en dm en t (P ub li c L aw 83 -5 18 ) to th e Fo od, D ru g, an d Co sm eti c A ct. ) A t pr es en t, th is tr a n si ti o n a l pr ov is io n of Pu bl ic La w 86 -13 9 is in co ns on an ce w it h th e tr a n si ti o n a l pr ov is io ns o f th e Fo od A dd iti ve s A m en dm en t of 1958 (P ub li c L aw 85 -9 29 ) ; th is wo ul d re m ai n tr u e u nde r th e p re se n t b ill. A de ta il ed e x p la n a ti o n o f th e ne ed fo r e n ac tm en t of th is bil l is en cl os ed he re w it h. W e th er ef or e, in vi ew o f th e ne ed f o r a n d u rg en cy of th es e am en dm en ts , re co m ­ m en d p ro m pt en ac tm en t of t h e bil l. W e a re ad vi se d by th e B u re au of th e B ud ge t th a t th e re is no ob je ct io n to th e p re se nt at io n of th is re p o rt fro m th e st a n d p o in t of th e a d m in is tr a ti o n ’s p ro g ra m Si nc er el y y ou rs , A b r a h a m R ib ic o ff , S e c r e ta r y . A dd it io na l E x pl a n a ti o n of P rop ose d F ood A dd it iv es T r a n s it io n a l P ro vi si o ns A m en d m en t of 1961 1. Se ct io n 2 o f bil l T he Fo od A dd iti ve s A m en dm en t of 1958 (P ubl ic L aw 85-92 9) am en de d th e F ed er al , Fo od, D ru g, an d C os m et ic Ac t so as to d ee m a d u lt e ra te d —a n d th u s b a r fr om in te rs ta te co m m er ce —a ny so -c all ed “fo od a d d it iv e ,” an d fo od bea ri n g o r co nt ai ni ng su ch a n ad di ti ve , un le ss th e sa fe ty of th e p a rt ic u la r a d d it iv e fo r it s in te nd ed us e ha d fi rs t liee n es ta bl is he d to th e sa ti sf a c ti o n o f th e D e p ar tm en t of H ea lth , E du ca ti on , an d W el fa re an d th e us e of th e ad di ti ve co mp lie d w it h to le ra nc e li m it at io n s or o th e r co nd it io ns of sa fe us e se t fo rt h in a sa fe ty -c le ar ­ an ce re gu la ti on is su ed w it h re sp ec t to th e ad d it iv e by th is D ep ar tm en t. B as ic al ly , Pu bl ic La w 85 -92 9 be ca m e ef fe cti ve on M ar ch 6, 1959 (ISO da ys a f te r th e d a te of e n a c tm e n t) . H ow ev er , w it h “r es p ec t to an y p a rt ic u la r co m­ m er ci al us e of a fo od ad di ti ve , if su ch us e w as m ad e of su ch ad di ti ve be fo re J a n u a r y 1, 1958,” th e pr ohib it ory pr ov is io ns (se c. 3) of P ub li c La w 85- 929 — i.e., th os e wh ich ha d th e ef fe ct of b a rr in g su ch foo d ad d it iv e s fr om th e in te rs ta te m a rk e t un le ss pr ev io us ly “c le a re d ” by th is D ep a rt m e n t— w er e to t ak e eff ec t o nl y a f te r a va ri ab le a d d it io n al gr ac e pe rio d or , if e ar li er , on th e d at e of th e e st a b li sh ­ m en t of an or de r pa ss in g up on th e sa fe ty of su ch p a rt ic u la r us e of th e ad di ti ve . T h is gr ac e pe rio d fo r su ch co m m er ci al ly es ta bli sh ed us es o f foo d ad dit iv es w as , in ge ne ra l. 1 y e a r be yo nd th e ba si c ef fe cti ve d a te (i.e ., M ar ch 6, 1960) ; how’ev er , th e S ec re ta ry w as em po w er ed to ex te nd it fo r as m uc h a s an o th er y e a r (i. e., to M ar ch 6, 1961) “o n th e b as is o f a fin di ng t h a t su ch e xt en si on i nv ol ve s no u nd ue ri sk to th e pu bl ic h e a lt h an d th a t co nd iti on s e x is t w hi ch nec es si ta te th e p re ­ sc ri bi ng of su ch ad d it io n a l per io d” (se c. 6 (c ) of P ub li c La w 85 -9 29 ). T he pu rp os e of th es e gra ce- i>e rio d pr ov is io ns w as to p er m it an or der ly a d ­ ju st m en t, on th e p a rt of in te re st ed in dust ri es , a s we ll as ou rs elv es , to th e ne w re qui re m en ts im po se d by P ub li c L aw 85 -92 9 in so fa r as foo d ad di ti ve s e st a b ­ li sh ed in co m m er ci al us e l»efo re J a n u a ry 1, 1958, w er e co nc er ne d, an d to p er m it th e af fe cte d in d u st ri e s to de ve lo p th e in fo rm at io n an d sc ie nt ifi c d a ta ne ed ed w it h re sp ec t to su ch a d d it iv es w it h o u t m ea nw hi le d is co nti nuin g th e m an u fa ct u re , m ar ket in g, an d us e o f su ch a d d it iv es no t pro hi bi te d u n d e r p ri o r law . I t w as fe lt a t th e tim e th a t, in ge ne ra l, a d ef er re d ef fe cti ve d a te of 18 m on th s fr om th e d a te of e na ct m en t (i. e., M ar ch 6, 1960 ) wo ul d suff ice fo r th is pu rp os e b u t it w as fo re se en th a t in a nu m ber of c as es th e ne ed fo r fu r th e r tim e, p a rt ic u la rl y w her e ad d it io n a l sc ien tif ic w or k w as re qu ir ed , wo ul d a ri s e ; he nc e th e S ec re ta ry w as gi ve n th e ab ov e- qu ot ed fle xib le a u th o ri ty to al lo w fu r th e r tim e in su ch ca se s on a n ad hoc* ba sis , pr ov id ed th a t no un du e ri sk to th e pu bl ic he al th w as i nv ol ve d in su ch po st po ne m en t. H ow ev er , fo llo w in g th e pre ce de nt of th e P es ti ci de Ch em - 4 FOOD ADDITIVES ical s Amendm ent (Pub lic Law 83-518 ), Public Law 85-929 set an out er limi t (i.e., March 6,1961) to such a d hoc postpon ements. Und er thi s aut hor ity , we have so f ar g ran ted over 3.000 ad hoc pos tponem ents of the effective dat e of section 3 of the Food Additive s Amendm ent with respec t to commer cially estab lishe d uses of food additiv es. The questio n whe ther Pub lic Law 85-929 should be amend ed to enable us to gr an t fu rth er postpone­ men ts beyond March 6, 1961. was rais ed in Jan ua ry 1960 in the course of our testi mon y before the Hous e Commi ttee on In ter sta te and Forei gn Commerce on the Color Add itive Amendment s of 1960 (whic h became Pu blic Law 8 6-618). We the n expre ssed the view th at con side ratio n of this questio n was pre ma tur e but tha t, if fu rth er experien ce should ind ica te th at the exi stin g au tho rity was in­ adeq uate , we would s ubm it a n ap pro pri ate leg islati ve p ropos al to Congre ss (p. 81, rep ort of hea ring s on H. R. 7624). Our experie nce since the n indi cate s th at the pres ent cutoff da te of March 6, 1961. will in fac t ope rate unfai rly in a numbe r of situ atio ns in which avail able evidence indi cate s th at conti nued use of an addit ive for limit ed time will be cons iste nt with the prote ction of the public health , and th e inte res ted perso ns in ind ust ry have exercis ed due diligen ce in sta rti ng a nd pur sui ng the necessa ry scientifi c work, but th at w ork can not possib ly be completed, le t a lone acted upon by us, before arr iva l of this cutoff dat e. The scientific pro blem i s acc entu ated by the fac t th at the Food Addit ives Amendm ent of 1958 app lies not only to sub­ stan ces dire ctly and purp osef ully adde d to food but also to so-called incid ental add itive s, th at is, subst ance s the inten ded use of which may reaso nabl y be ex­ pected to res ult indi rectl y in the ir becoming a component or other wise aff ecting the ch ara cte ris tic s of foected to be complet ed by March 6,1961. Section 2 of the bill—which is the prin cip al pa rt of the bill—would ther efo re aut hor ize us, in cases of thi s kind, to postpone the effective da te of section 3 of the Food Additiv es Amendm ent of 1960 beyond March 6, 1961, to the ext ent th at thi s is cons isten t with public hea lth protec tion and is, in our judgm ent, nece ssary to complete such scientifi c work in good fai th. (Th is appro ach is sim ilar in concept to th at rece ntly adop ted by Congress in the Color Additive Amendm ents of 1960 (Pub lic Law S6-6 18)) . Moreover, the bill would enable us to invoke thi s au tho rit y only wh ere we have previous ly gra nte d an extens ion to March 6. 1961 (th e lim it of our pres ent au tho rit y), and nece ssary inqu iries or stud ies were sta rte d before March 6, 1960, and since the n purs ued with reas onab le diligence. (We do not believe th at those who hav e food add itive problem s but have done lit tle or noth ing to solve them should receive specia l cons ider ation .) Fin ally , as in the eas e of the Color Add itive Amendm ents of 1960. the bill would aut hor ize u s to ter mi na te a postpo nement a t any time when we find th at i t should not have been gra nte d in the first place, or t ha t by reason of a change in circu msta nces the basi s for the postpo nemen t no longe r exists , or th at the re has been a fai lur e to comply with a requ irem ent for submission of prog ress rep ort s or with oth er condit ions atta che d to th e postpone ment. FOOD ADD ITIV ES 2. Section 3 of bill (re neniatocide s, plan t regula tors, defo liant s, and desic cants) Under the Food Addit ives Amendm ent of 1958, the definition of the term ‘‘food add itive ” expres sly excludes “a pestic ide chemica l to the ex ten t th at it is intende d for use or is used in the produ ction, stora ge, or tra nsp ort ati on of any raw ag ric ult ura l commodit y.” The reaso n for thi s exclusion is th at the regula tion of resi dues of “pestic ide chem icals” in or on raw agr icu ltu ral com­ modities was alr ead y ade quat ely provide d for from the publ ic-hea lth sta nd ­ point by the Pes ticid e Chemicals Amendm ent (Pu blic Law 518, 83d Cong.) to the Fed eral Food, Drug, and Cosmetic Act. The term “pestic ide chem ical” is defined by th at amen dmen t as “any subst ance which * * * -is an ‘economic poison' wit hin the meani ng of the Fed eral Insec ticid e, Fungicide, and Rodent i- cide Act (7 U.S.C., 135-135( k)) as now in force or as he rea fte r amende d, and which is used in the produ ction, storage , or tra nsp ort ati on of raw7 ag ric ult ur al commodities.” Originall y, the Fed eral Insectic ide, Fungicid e, and Roden ticide Act, which establi shed a reg istr ati on system (ad min iste red by the Dep artm ent of Agric ul­ tur e) for “economic i>oisons,” confined th at te rm, basical ly, to insecticid es, fun gi­ cides, rodenti cides, and weedkil lers. The Nematocid e, Pla nt Regu lator , De­ folia nt, and Desic cant Amendme nt of 1959 (Pub lic Law 86-139) expa nded the definition of “economic poison” in the Insec ticide , Fungicid e, and Rode ntici de Act to include neniatoc ides, and, also, any subs tanc e inten ded fo r use as a “pla nt reg ula tor, ” defo liant , or desicca nt. As a resu lt, chemica ls in the se fou r categorie s, used in the pnx luct ion of a gri cu ltu ral cr ops, w7ere no long er c lassified as “food add itiv es” und er the Fed eral Food, Drug , and Cosmetic Act but were auto mati cally cla ssified as “pesti cide chemic als.” However, in ord er to per mit an orde rly tra ns iti on for both the Govern ment and indu stry , section 3 of Publi c Law7 86-139 provid ed for tra nsi tio na l time I>eriods, eyed t o th ose specified in the Food Addit ives Amendment of 1958, du ring which (1) cer tai n civil and crim inal sanct ions, etc., of t he Inse cticide , Fu ngicid e, and Rodenti cide Act would not apply, and (2) the adu lte rat ion prov ision7 s of the Food and Dr ug Act an ted ati ng the Pest icide Chemica ls Amend ment would contin ue to apply to cer tai n of thes e prod ucts. Thus, section 3(b ) of Publi c Law 86-139 provi des tha t, with respe ct to any par tic ula r commer cial use of a nematocid e, pl an t regu lator , defo lian t or desic ­ can t in or on a raw7 ag ric ult ura l commodity, “if such use was made of such substa nce before Ja nu ar y 1, 1958,” the old ad ult era tio n provisions of the Food and Drug Act sha ll conti nue to apply unti l March 5, 1960, or unt il the end of such addi tion al i>eriod, not beyond March 5, 1961, as the Secr etary of Hea lth, Educati on, and We lfar e may presc ribe “on the ba sis of a finding t ha t c ondit ions exis t which nec ess itat e the presc ribin g of suc h add itio nal period.” (If , however, a toleran ce or exemp tion ther efro m und er the Pes tici de Chemicals Amendment , i.e., section 40S of the Food and Drug Act, were sooner estab lished for such use of the subst ance, thi s tra dit ion al perio d w7ould end at th at time with respe ct to such use ). The p rese nt bill would amend sectio n 3(b ) of Public Law 86-139 so to enable the Sec reta ry of Healt h, Educa tion, and We lfare to postp one the cutoff date of March 5, 1961, on an ad hoc basi s w’here necess ary for comp letion of scientific work, subje ct to safe gua rds and lim ita tio ns exact ly par alle l to those contai ned in section 2 of thi s bill w7hich amen d the tran siti onal provis ions of the Food Addit ives Amendm ent of 1958. Thi s au tho rit y is needed in ord er to make possible the bona fide completion of needed scientific st udies th at ca nnot be completed by M arch 5, 1961. Changes in exis ting law7 made by bill to amen d the tra nsi tio nal provis ions of the act appro ved Septem ber 6, 1958, enti tled “An ac t to prote ct the public heal th by amen ding the Fed eral Food, Drug, and Cosmetic Act to pro hib it the use in food of add itiv es which hav e not been adeq uate ly tested to esta blis h th eir safe ty,” and for oth er purposes, are shown as follows (exi sting law in which no changes ar e proposed ar e show7n in ro m an ; new ma tte r is pri nte d in ital ic) : 1. F ood A ddit ives A me nd me nt of (Pub lic La w 85-929) “S ec. 6. (a) Exc ept as provid ed in subse ctions (b) thi s Act sha ll ta ke effect on the da te of its enac tmen t. . “ (h) Except as provided in subsec tion (c) of this sectwif^eOTiOT'ffT$r Act shall tak e effect on the one hun dred and eig hti eth da k af te r the dafK i enac tmen t of thi s Act. 667 38— 61 ------ 2 6 FOOD ADDI TIVES “ (c ) W it h re sp ec t to a ny p a rt ic u la r co m m er ci al u se of a foo d ad di ti ve , if s uc h us e w as m ad e of su ch ad d it iv e be fo re J a n u a ry 1, 1958, se ct io n 3 of th is Ac t sh a ll t ak e eff ec t— “ (1 ) e it h e r (A ) on e y e a r a ft e r th e ef fe cti ve d a te es ta bli sh ed in su b­ se ct io n (b ) of th is se ct io n, or (B ) a t th e en d of su ch ad d it io n al pe rio d (h ut no t la te r th a n tw o y e a rs fr om su ch ef fe cti ve d a te es ta bl is he d in su b­ se ct io n ( b ) ) as th e S ec re ta ry of H ea lt h, E du ca tio n, a n d W el fa re m ay pre ­ sc ri be on th e ba si s of a fin di ng th a t su ch ex te ns io n in vo lv es no un du e ri sk to th e pu bl ic hea lt h an d th a t co nd iti on s e x is t w hi ch ne ce ss it at e th e pr es cr ib in g o f s uc h an a d d it io n a l pe rio d, or “ (2 ) on th e d a te o n w hi ch an o rd er w it h re sp ec t to su ch us e un d er se ct io n 409 of th e F ed er al Fo od , D ru g, an d Co sm eti c Ac t be co me s eff ec tiv e, w hi ch ev er d a te fi rs t oc cu rs. Whe nev er the Secr etar y has, purs uan t to clause (1 )( B ) of this subsectio n, exte nde d the effectiv e date of section 3 of this Ac t to March 6, 1961, with respec t to any such part icula r use of a food addi­ tive, he may, not wit hsta ndi ng the pare nthe tica l time lim ita tio n in tha t clause, fu rth er exte nd such effec tive date under the aut hor ity of tha t clause (but, subje ct to clause (2) wit h respec t to such use o f the add itiv e (or a more limite d specified use or uses the reo f), if, in addi tion to makin g the findings required by clause (1 )( B ), he finds (i) tha t bena fide action to dete rmin e the applic ability of such section 1/09 to such use or uses, or to develop the scien tific data necessar y for action unde r such section, was commenced by an inter este d person before March 6, 1960, and was the rea fte r purs ued with reasonable diligence, and (ii) tha t in the Sec reta ry's jud gme nt such exte nsio n is cons isten t wi th the object ive of carry ing to completion in good fa ith , as soon as reasona bly practicable, the scien tific inve stiga tion s neces sary as a basis fo r action und er such sectio n 1/09. The Secr etar y may at any time term ina te an exte nsion so granted if he finds tha t it should not have been grant ed, or tha t by reason of a change in circum ­ stance s the basis fo r such exte nsio n no longer exist s, o r tha t there has been a fai lur e to co mply wi th a re quir eme nt fo r submis sion of progress reports or with oth er cond itions a ttach ed to s uch e xten sion .” 2. Nematocide, P lant R egulator, D efoilant, and Desiccant Amendment of 1959 (P u b li c La w 8 6-1 39) “S ec. 3. T hi s Ac t sh al l ta k e ef fe ct on th e d at e of it s en ac tm en t, ex ce pt th a t— “ (a ) w ith re sp ec t to an y ne m at oc id e, p la n t re gul at or, de fo il an t, o r de si c­ c a n t w hi ch w as m ar ket ed co m m er ci al ly pri or to th e d a te of en ac tm en t an d w ho se us e do es not re s u lt in re si due s of sa m e re m ai nin g in or on a foo d, an d w ith re sp ec t to an y ne m at oc id e, p la n t re gu la to r, def oil an t, or de si cc an t w ho se us e do es re su lt in re si d u e re m ai nin g in or on a foo d a t th e ti m e of in tr o d u ct io n in to in te rs ta te co m m er ce an d wh ich us e h ad co m m er ci al ap pli ­ ca ti on p ri o r to J a n u a r y 1, 1958, se ct io n 3, “P ro h ib it ed A ct s” ; se ct io n 8, “ P en al ti es ” ; se ct io n 9, “S ei zu re s” ; an d se ct io n 10, “ Im p o rt s” , o f th e F ed er al In se ct ic id e, Fu ng ic id e, an d R od en ti ci de Ac t, w hi ch th is Ac t am en ds , sh al l no t be ap pl ic ab le u n ti l— “ (1 ) M ar ch 5, 1960, o r su ch la te r dat e, no t be yo nd M ar ch 5, 1961, as th e S ec re ta ry of A g ri cu lt u re m ay pr es cr ib e on th e ba si s of a de ­ te rm in at io n th a t su ch a ct io n w ill not b e un du ly d e tr im e n ta l to th e pu bl ic in te re st a nd i s n ec es sa ry t o av oi d har dsh ip s, o r “ (2 ) th e d a te on w hi ch a re g is tr a ti o n fo r su ch us e is is su ed u nd er th e F ed er al I ns ec tic id e, F un gi ci de , a n d R od en tic id e Ac t, w hi ch ev er d a te f ir st o c c u rs : an d “ (b ) w it h re sp ec t to a ny p a rt ic u la r co m m er ci al us e of a ne m at oc id e, p la n t re gul at or, de fo li an t, o r des ic ca nt in or on a ra w a g ri c u lt u ra l co mm od ity , if su ch us e w as m ad e of s uc h su b st an ce be fo re J a n u a ry 1, 1958, se ct io n 40 6 (a ) a n d cl au se (2 ) of se ct io n 4 0 2 (a ) of th e F ed er al Fo od , D ru g, an d Co sm eti c A ct a s in fo rc e p ri o r to th e d a te of th e en ac tm en t of th e A ct of Ju ly 22, 1954 (68 S ta t. 511 ) (r e la ti n g to p es ti ci de c he m ic al s on ra w a g ri c u lt u ra l com ­ m od it ie s) sh al l a ppl y u n ti l— “ (1 ) M ar ch 5, 1960, or th e en d of su ch ad d it io n al pe rio d, not be yon d M ar ch 5, 1961, as th e S ec re ta ry of H ea lt h, E du ca ti on , an d W el fa re ma y p re sc ri be on th e ba si s of a fin di ng th a t su ch ex te ns io n in vo lv es no un du e ri sk to th e pu bl ic h ea lt h an d th a t co nd iti on s e x is t w hi ch ne ce ss ita te th e p re sc ri bi ng of su ch a n a d d it io n a l p er io d, o r FOOD ADDITIVES Z “ (2) the (late on which an ord er with resp ect to such use und er sec­ tion 408 of the Fed eral Food, Drug, and Cosmetic Act (21 U.S.C. 346a) becomes effective, whiche ver da te first o ccurs. Whe neve r the S ecr eta ry of Health, Educ ation , and. Welfa re has, purs uant to clause (/ ) of thi s paragraph, (&). prescribe d an additio nal period expi ring on March 5, 196J, with respect to any such partic ular use of a nematoe ide, plant regulat or, defoli ant, or dessica nt, he may, not wit hsta ndi ng the provis ion to the con trar y in such clause (I ), fu r­ ther e xtend the exp irat ion date applicable und er such clause (1) (bu t suIn­ ject to clause (2 )) wi th respect to such use of such substan ce (or a more limite d specified use or uses the reo f), if, in additio n to m aking the findin gs required by clause (1 ), he f inds (A) that bona f ide actio n to dete rmi ne the applic ability of such section JfilS to such use or uses, or to develop the scien­ tific data neces sary for action unde r such section, was commenced by an inter ested person before March 6, I960, and was ther eaft er pursue d wit h reasonable diligence, and (B ) that in the Sec reta ry's judgm ent such ext en ­ sion is c onsis tent wi th the object ive of carry ing to c ompletio n in good f ait h, as soon as reasona bly practicable, the scien tific inve stiga tions nece ssary as a basis f or action under such section 1/08. The Secr etar y may at any time term inat e an exten sion so grante d if he finds tha t it should not have been granted, or tha t by reason of a change in circu mstan ces the basis for such exten sion no longer exis ts, or that there has been a fail ure to comply with a requir ement for submis sion of progress repor ts or wi th other conditi ons attached to such e xten sion .” The Chairman. I observe, first, that we have a couple of our col­ leagues here who are tremendously interested in this problem. My at­ tention has been called to the fact that they have urgent business be­ fore their own committees, so, Mr. Secreta ry, if you will permit, I shall recognize first one of our colleagues who has been interested in this problem over a number of years, and to whom we are indebted fo r the contribution he has made to the problem, the Honorable Jame s J. Delaney of New York. Mr. Delaney, we are very glad to have you with us again, and we appreciate your concern and interest in this problem. STA TEM ENT OF HON. JAM ES J. DEL ANE Y, A RE PR ES EN TA TI VE IN CONGRESS FROM TH E STA TE OF N EW YORK Mr. Delaxf.y. Thank you. Mr. Chairman. Mr. Chairman, I appreciate the oppo rtuni ty to give my views on II.It. 3980, and I shall be very brief. The Food Additives Amendment of 1958 was a s ignificant step for­ ward in the protection of the safety o f our food supply. As you know, it was the end result o f an intensive investigation of the use of chemi­ cals in foods by a select committee o f the House, of years of effort by dedicated scientists and representative s of the consuming public and of extensive hearings conducted by this committee. Efforts will be made to weaken this law and to make its enforcement difficult. This must not be allowed to happen. The public interest demands that the law and its enforcement lie streng thened rathe r th an relaxed. All of us have a serious responsibility in this field. Nevertheless, I realize tha t a law as fa r reaching as the Food Add i­ tives Amendment of 1958 presents problems to many of the industrie s affected by it. While I deeply reg ret that it has ap paren tly been im­ possible by this date to complete the required testing of all the food additives now in use, we can hardly afford to throw our food su pply into chaos by an abrupt and a rbit rary with drawal of them. 8 FOOD ADDIT IVES I hav e no qu arr el wi th the p rin ci pa l p urp ose s of H. R. 3980. Ac cor d­ in g to its ter ms , a com pan y th a t can show th at it has ser iou sly an d di lig en tly a tte m pt ed to co mp ly wi th the pr ovi sio ns of th e law, bu t w as unab le to com plet e its effo rts by M arc h 6, 1961, ma y be gr an te d an ext ens ion o f tim e b y th e S ec re tar y of H ea lth , E du ca tio n, a nd W elf are , if he f inds th at the re is no u nd ue ris k to the pu bli c he alt h. Th e Fo od an d D ru g Ad m in ist ra tio n ass ure s me th at no ext ens ion wi ll b e g ra nt ed in a ny case whe re u ndu e ri sk is inv olved. I un de rst an d th at some in du str ies obje ct to th is req uir em en t, an d F ra nk li n M. D epew , p re sid en t o f t he Fo od La w In st it ut e, h as been re ­ po rte d as sa yin g th at che mic als sho uld no t be ba rr ed ju st becaus e of lac k o f di lige nce on th e p ar t of t he s up pli er. I t is ag ain st at tit ud es l ike thes e th at we m ust be on the ale rt. Ce r­ ta in ly , I w ould vi go rou sly o ppo se an y l egi sla tio n th at di d no t pro vid e at le ast the se min im um saf eg ua rds . My ma in obj ecti on to II .R . 3980 i s th at it pe rm its “op en en d” tim e extens ion s. I st ro ng ly beli eve th at a t the m ost a 2 -ye ar tim e e xten sion sho uld be gr an te d, an d th at the new cutoff da te fo r tho se cases th at come wi th in the p ur vie w of t hi s bill sho uld be no la te r th an Ma rch 5, 1963. Ju d g in g b y past, at tit ud es , un less th is is spel led ou t in t he leg isl ati on, ma ny com pan ies will st ar t dr ag gi ng th ei r feet, an d th e res ult will be th at the 1958 ena ctm ent wil l f al l fa r sh ort of it s ob jecti ves. I f it is a rg ue d t ha t a 2-y ear exte nsi on is not en ough, th en I say, “L et ’s look at the sit ua tio n ag ain in 2 y ea rs. ” If , at t he e nd of t h at t ime , it can be pro ven th at a fu rt he r exte nsio n is ne eded in some cases, we can th en deci de w ha t ac tion to take . Mr . Ch air ma n, ha vi ng won gr ou nd in ou r figh t to pro tec t th e con ­ sum er, w ec an aff ord no re tre at . An open end bi ll wou ld be a re tre at . II .R . 3980, w ith th e in clusion of a cu toff dat e of M arc h 5, 1963, would be en tir ely fa ir to in du str y, an d, to ge th er wi th ot he r sa fe gu ar ds al ­ rea dy in it, woul d offer the pu bli c some ass ura nce th at its pr op er in ­ ter es ts a re o f co nti nu ing conce rn t on s. I ur ge th at th e bill be am end ed to t h at effect. Th e C ha irm an . Th an k you ver y much , Mr . De lan ey , fo r yo ur sta tem en t. Mr. W illi am s, do you h ave an y q ues tion s ? Mr . W illi am s. I hav e n o qu esti ons . Th e C hair man . Mr. Sch enc k? Mr. S ch en ck . Xo que stio ns. Th e C hai rm an . Mr . Ro ber ts? Mr . R oberts. X o ques tions . Th e C hai rm an . Mr. Yo unger ? Mr . Y orNGER. Xo q uest ions . Th e C hai rm an . Mr . F rie de l ? M r. F riedel . Xo ques tion s. Th e C ha irm an . Mr. Av ery ? Mr . A very. X o que stio ns, bu t I wou ld like to th an k ou r colle ague fo r gi vi ng us the benefit of his ju dg m en t on th is m at te r, becau se we look to h im fo r adv ice in th is w hol e are a. Th e C hai rm an . Do any of ou r colle ague s hav e an y que stio ns? Mr . De lan ey, you seem to hav e mad e yo ur sel f ve ry cle ar to the memb ers of th is com mitt ee in view of the fa ct th ere ar e no que stio ns abo ut a tec hni cal pr obl em li ke thi s. FOOD ADD ITIV ES 9 I would like to ask one question. Suppose you h ad a substance th at has not yet been declared to be a food additi ve, bu t at some late r date is declared to be a food additive. Should the affected indust ry be given time for investiga tion to determine t he saf ety of th is substance? Mr. Delaney. This deals only with the 3,000 petitions tha t the Food and Drug Adm inistr ation has before it. Any new additive must meet the requirements of the law, or any thin g not included up to this date. This deals with only those t hat are known and on t he books where there has been insufficient time to test. The Chairman. I realize that. Sometimes it disturb s me a little bit, though, to say tha t a substance afte r a grea t effort h as gone into it, is being produced and has not been determined to be a food additive , and then later up comes the decision tha t this is a food additive. Wh at happens then ? Mr. D elaney. I thin k in those cases that we could take anothe r look at it 2 years from now, and if an extension is needed, I feel t ha t it should be granted. We have 3,000. Suppose at the end of the 2-yea r testin g period there were 2,500 t hat had been acted upon one way or the other, and th ere were 400 or 500 th at needed add itional time. If the petitioners could show to the satisfac tion of the Food and Dru g Adminis tration tha t they need more time, we could come in here and I do not know t ha t t here would be any objection on my p art at th at pa rticu lar time. The Chairman. Than k you very much. We appreciat e your testimony. Mr. D elaney. Thank you, sir. The Chairman. We are also glad to have w ith us this morning our colleague, the Honorable David S. King. Mr. King, we apprecia te your interest in this problem and we are very glad to have your test imony. STATEMENT OF HON. DAVID S. KING. A REPR ESE NTA TIV E IN CONGRESS FROM THE STATE OF UTAH Mr. K ing. Thank you, Mr. Chairman and members of the commit­ tee, I have a short statement which is being distri buted consisting of only thre e paragr aphs. Mr. Delaney has covered practica lly all o f the mater ial contained in my statement, and in order to conserve time, therefore, I should like to read just the concluding par agr aph o f my statement, asking t ha t the entire statement be includ ed in the record. The Chairman. Wit hou t objection, the entire statement will be i n­ cluded in the record. Mr. K ing. I appreciate the opport unity of appe arin g before this distinguish ed committee to give brie f testimony on the mat ter of fur the r extending the effective date beyond March 6, 1961, for the scientific investigations necessary under section 409 of Public Law 85-929, which inve stigations are designed to s afegua rd the health of the American public by requiri ng tha t food additive s be adequately tested by the manufa cturers before being authori zed for human con­ sumption. In view of the fa ct th at many ad ditives h ad been in common use be­ fore the enactment of Public Law 85-929 by the 85th Congress, the manu factur ers of such additives were grant ed what was considered 10 FOOD ADD ITIV ES to be a reas ona ble t im e in whi ch to com plete the scien tific testi ng re ­ qu ire d by t he l aw. Ex pe rie nc e ha s now pro ven th at t he ti me a llowe d was not sufficient, in ma ny cases, to com plete the req uir ed tes ts, and H. R. 3980 prop oses th at the Se cr et ar y be au tho riz ed to gr an t ex ten ­ sion s as nece ssar y fo r the com ple tion of tes ts whic h hav e been un de r­ tak en an d ca rri ed ou t wi th rea son able dili gen ce on th e pa rt of ma nu ­ fa ct ur er s. We con sid er it rea son abl e th a t nece ssar y ext ens ion s be gr an ted, but we wou ld obje ct str on gly to any acti on whic h mi gh t weaken the enf orc em ent o f th is hig hly i m po rta nt act. In o rd er th at t he Con gres s mi ght revi ew the pro gre ss mad e by th e Se cre tar y in th e enf orc em ent of th e pro vis ion s o f P ub lic Law 85—929 an d con tinu e its i nt er es t in t he pro tec tio n o f t he he alt h o f th e A me ric an pe ople, we str on gl y urg e th at the tim e exte nsio n gr an te d to m an uf ac tu re rs fo r testi ng be fixed at M arc h 6, 1953, ra th er th an gra nt the Se cre tar y ope n-en ded au th or ity fo r th e gr an ti ng o f ext ens ion s to m an uf ac tu rer s. Ju st i n c onc lud ing , M r. Ch air m an , m y fee lin g is t h at th e public law whi ch we are con sid erin g, 85-929 , co ns titu ted a hig h wa ter ma rk , a his tor ica l lan dm ar k, in the cou rse of leg isla tion de ali ng wit h pu re foods. We feel th a t it wou ld be ext rem ely ha zar do us at th is tim e to do an yt hi ng whic h mi ght wea ken th e enf orc em ent of th is .act. We rea lize (h at a ce rta in am ount of p las tic ity is nece ssary . We do not obj ect t o t ha t. How eve r, gr an ti ng an ope n-e nd exte nsio n, we feel wou ld be goi ng bey ond reas ona ble ela sti cit y an d th at i t wou ld resu lt in we ake nin g th e basic law itse lf. May I say, also, th a t I sho uld like to asso ciate my ­ sel f com ple tely wi th the r em ar ks of th e dis tin gu ish ed g ent lem an from New Yo rk, M r. Del aney , whom I con sid er t o be one of th e g re at heroe s in th is fig ht to ma in tai n an d pre ser ve pu re food fo r th e Am eric an public. T ha nk you. Th e C hai rm an . Th an k you ver y muc h, Mr. Ki ng, fo r yo ur sta te ­ ment . We ap pr ec iat e ha vi ng yo ur exp ress ion of in ter es t in thi s leg isla tion . Ar e t he re any que stio ns? Mr. A very. I ha ve ju st one. Th e C hai rm an . Mr. A ver y. Mr. A very. Mr. Ki ng , you mad e a ref ere nce as to “w eak eni ng of thi s bil l.” Do y ou con sid er a sim ple exte nsio n of tim e as m ate ria lly or s ub sta nt ial ly w eak eni ng t he bill or the sta tu te in a ny wa y ? Mr. K ino . A s I a tte mp ted to po in t o ut, I th in k th at i n jecting a li ttl e ela sti cit y int o the bill wou ld no t weak en it. I th in k the wea ken ing comes whe n th e ela sti cit y is str etc he d beyo nd rea son abl e lim its. I feel th at g ra nt in g an ope n-en d exte nsio n here wou ld lie ca rr yi ng it too fa r. T ha t. I th in k, wou ld lie we ak en ing it. I wou ld not obj ect to pla cin g a 2-y ear lim ita tio n, and as Mr . Del ane y point ed out. If at the e nd of th at 2 y ear s, we stil l hav e a prob lem , we can ree xam ine it and p er ha ps have a f urt her exte nsio n at th at t ime. Mr. ? very. Th an k you. Mr. K ino . Th an k you. T he C hai rma n . An y fu rt her qu est ion s? Tha nk you ver y m uch. Mr. Ki ng . Mr. K ing . Th an k you. FOOD ADD ITIV ES 11 The Chairman. We are now gratified to have with us this mo rning for the first time a fo rmer colleague of ours, who has now the distin c­ tion, and privilege, and high honor of serving in the position of Secretary of Healt h, Educati on, and W elfare. In view of the fact tha t we have many problems being admin is­ tered by your Departm ent, Mr. Secretary, we a re exceedingly glad to have you with us this morning for the first time. 1 am sure tha t we shall be looking for ward to more meetings with you in connection with legislation which your Departm ent will be involved in. I am partic ularly glad that you were able to meet with us toda y in view of the fact tha t this is the first hea ring that the committee has sched­ uled and conducted in this session of Congress. Furth ermo re, we appreciate you being here in order to renew yo ur acquaintance with some of us who served with you in the Congress when you were here and to meet those who did not have tha t privilege. I realize full well that this is a highly technical problem we have before us today and that you may very well call on some of your associates in connection wit h some of the testimony here this morning. At the outset, I think, it would be helpful if you would iden tify the associates with you here this morning in orde r that the committee may know them and they, of course, may know the committee better . STA TEM ENT OF HON. ABR AHA M RIB ICO FF, SEC RET ARY , DE PA RT ­ MEN T OF HE AL TH , EDUCA TION, AND W E L FA R E ; ACCO MPANI ED BY GEORGE P. LA RR ICK , COMM ISSION ER, FOOD AND DRUG AD MI N­ IST RA TIO N; AND JOH N L. HA RV EY , DE PU TY COMMIS SIONER , FOOD AND DRUG AD MI NIS TR AT ION M?. R ibicoff. Than k you very much, Mr. Chairman, for your gracious remarks. It is really a pleasu re to come here and renew my acq uaintanceship with you, Mr. Chairm an and many o f the members of the committee whom I have known for so many years. I am pleased to see two close friends on the Republican side who are new members. Congress­ man Sibal of Connecticut was Republican leader in the Connecticut General Assembly durin g my term of governorsh ip and Congressman Thomson was a fellow Governor from Wisconsin, who I respected so much in our working t ogethe r in various G overnors’ conferences. I am very interested to find tha t some of the most important work of health, education, and welfare comes within the jurisdiction of this most im portant committee. Some of these prog rams are of g reat im­ portance for the futu re of our Nation and I look forward to lieing here many, many times to testify before this committee. I would hope tha t a t any time a ny member of th is committee personally might have a problem, or a question, or an inquiry concerning anv parts of mv Departmen t, you would not hesitate to pick up t he telephone and call me and we will try to get the replies to you as fas t as possible. I did think that since this is a new admin istratio n, I would like to introduce to you the top people in this Departm ent who will be here in addition to myself and who will be working with this committee: Mr. Ivan A. Nestigen, Under Secretary, Mr. Wilb ur Cohen, As­ sista nt Secretary, Mr. James Quigley—a fo rmer colleague of yours— 12 FOOD ADD ITIV ES Assistan t Secretary , Mr. Bo isfeuillet Jones, Assistant for Medical A f­ fairs, and Mr. Alanson Willcox, General Counsel. I believe you all know Mr. Larrick and Mr. Har vey, who are career men in this par tic­ ular field. Mr. Cha irman and members of the committee, I apprec iate the op­ portu nity to discuss with you the proposal for legislation to authorize fur the r extensions of the date on which the food additives and pesticide chemical amendments of the Feder al Food. Drug, and Cosmetic Act will become effective. The two pert inen t statutes were to have become effective on March 5, 1960, but in each case there was a provision for admini strative action to ex tend the effective date to March 5, 1961, on a showing that the extension was necessary and tha t the part icul ar use involved would present no undue haza rd to the public durin g that period. You will recall tha t early last year, representa tions were made to this committee that the 1 additiona l year provid ed in the sta tute would not be sufficient. At tha t time, my predecessor, Sec retary Flemming, urged th at the food additives amendment be pe rmitted to stand with a clear unde rstand ing th at if experience demonstrated the need for fu r­ ther extension beyond March 5, 1961, the De partment would so advise this committee. In the field of food additives real progress has been made durin g these past 12 months. Indus tries involved have worked intensively in end eavoring to solve the ir problems and obta in the necessary data on which suitable regulations can be based to perm it the continued use of substances which can be shown to be sa fe for the public at large. The Food and Drug Admin istration advises me tha t despite the diligent work of the industrie s and this Department , there is a real need for the autho rity for fur the r extensions as outlined in H.R. 3980. The bill includes safegua rds to prevent dilat ory tactics, but the keystone of any extension which could be gran ted under the auth ority of this bill is in the requireme nt for a showing tha t the extension will not present any undue hazard to the public health. It is not planned that blanket extensions will be grante d for a single period. Instead , t he fact in each case must be taken into con­ sideration. No more time should be authorized tha n is necessary to obtain the required data on this matt er of safety for permanen t usage of the p arti cul ar item involved, whether it be a direct additive or one which becomes a pa rt of the food thro ugh migra tion of pack­ aging or plan t equipment components. If at any time a question of safety arises while an extension is effective, the bill authorizes immediate terminat ion of tha t extension where th e facts war rant such action. The situatio n with respect to the pesticide po rtion is a comparable one appl ying only to nematocides, pla nt regulators, defoliants, and desiccants. A limited number of substances are involved here, but there has been shown to be need for fur the r time to enable i ndust ry and agricu lture to acquire the data the scientists of the Food and Dru g Admi nistra tion feel is necessary before formal regulatio ns can be granted. Air. Larr ick is prepa red at any time to provide specific i nform a­ tion on developments under this food additives amendment. I do believe t ha t thi s bill is in the intere st of t he Government, consumers. FOOD ADD ITIV ES 13 and the affected industrie s and respectf ully request a favorable report. Mr. L arrick , who is the Commissioner of Food and Drug, is here , gentlemen, to supply any detai led in formatio n. He ha s been working in this field durin g these years, and is certainl y bette r acquainted at this time with the details tha n I am, and if ther e are any ques­ tions, Mr. Chairman, I do believe tha t Mr. Lar rick could supply the details to you, Mr. Chairman , and the members of the committee. The Chairman. Mr. Secretary, than k you very much for vour statement. Mr. Larrick , do you have any fur the r comments to make? Mr. L arrick. Mr. H arris , I would like to tell th e committee which passed thi s food additives legislation, to acquaint my friends on this committee with some of the things tha t have happened as a result of your handling of this legislation 2 years ago, if you care to hear it. I would like to tell you wh at has developed unde r the legislation and then where we stand today. The Chairman. Very well. We would be glad to have your comments. Mr. L arrick. The food ad ditives amendment of the Federal Food, Drug, and Cosmetic Act is unquestionably a most impo rtant ad dition to the laws designed to safegua rd the food supply of this country. Though not yet fully in effect, it has already brou ght about gr eat im­ provements in the production and hand ling of food; because of the amendment the American consumer is receiving grea ter protection than was possible before. As you know, the amendment requires the person who wishes t o introduce an additive into the food supply to establish the safety of the proposed use of the chemical before it is employed commercially in food. This new look at the ingredie nts of food has covered not only sub­ stances added dir ectly to food, but also substances which get i nto food in o ther ways, as from food h andlin g equipment and food wraps. Since September 1958, the Food and D rug A dmini stratio n has done much to implement th is consumer protection. We have handled over 4,200 formal requests for informat ion or review of d ata on food ad di­ tive problems. We have engaged in hundr eds of informa l discussions with indust ry to explain and explore the a dminis trative and technical requirements of this law. We have published lists of 718 chemicals used with foods which are generally recognized as s afe by app ropr i­ ately qualified scientists, and thus a re exempt from the application of the food additives amendment. We have published lists of 112 substances that, ha ve prio r sanction and thu s are exempt from the food additives amendment. We have received 391 petitions for food additiv e regulations. Of the se: 100 were not complete enough to be filed ; 42 did not relate to food additiv es; 178 are being actively eva luated; 59 led to the issuance of regulations sta ting safe conditions fo r using and add itives inv olved; and a few petitions were withdrawn af ter filing. The 391 petitions received t hus f ar have involved over 1,900 uses of chemicals in food pr oduction, processing, or han dling. To pe rmit an orde rly tran sition , the food additives amendment gave us auth ority to extend the date upon which the law would become fully effective with respect to an additive fo r a maximum o f 30 months 66 73 8— 61 3 14 FOOD ADD ITIV ES from the date of enactment, th at is, to M arch 5, 1961, provide d the ex­ tension is necessary and “involves no undue risk to the public health .” In accordance with this autho rity, we have extended the effective date of the law to March 5, 1961, for over 3,000 uses of chemicals that may be subject to the amendment, a nd we have a bout 50 requests for additio nal extensions whose processing awaits the submission of more data. In 1958, when the food additives bill was before th is committee, we believed tha t a 30-month tran sition period would be long enough to permit resolution of the principal problem s that would arise. It is now evident tha t this was not enough time. In large measure th is is due to the fact tha t the problem is much larg er than anyone reali zed in 1958. An occasional expert may have had a good idea of the number of chemicals being used in his par ticu lar industry , b ut no one person was in a position to know of the v ast number of uses of food ad ditives in the entire food field tha t would need to be cleared under the new law. So there are numerous food a dditives being employed today to the benefit of consumers and indust ry which still require clearance. And we have no a utho rity under the law to g ran t time beyond March 5 of this year. We believe th at it would be in the p ublic inte rest to amend t he food additives law to perm it fur the r extensions of its effective date under circumstances tha t will safegu ard the public health. Our Dep art­ ment d raft ed the bill which is before you as I I.R. 3980 to accomplish this. The safeguar ds in II.R. 3980 are impor tant. The princ ipal ones are: 1. We could gra nt fur the r extensions only for products and uses tha t were being commercially employed before Janua ry 1,1958. This provides a background of experience t ha t lends s upport to the deci­ sions of our scientists tha t continued use fo r a limited time will n ot jeopardize the public health. 2. We could gra nt fur the r extensions only where cond itions exist which necessitate the prescribin g of an addition al period. 3. We could gra nt fur the r extensions only for additiv e uses t hat already have been gran ted extensions to March 5, 1961, o r u nder an amendment which I will discuss in a moment, fo r uses fo r which r e­ quests for extension are pending on tha t day. This precaution is desirable to guarant ee tha t the auth orit y for fur ther extensions does not serve as an excuse for inerti a and inactivity by the affected industries. Some could in terp ret the absence o f such a saf eguard as an in vita­ tion to wait for t he Government to determine t ha t their use of a chem­ ical employed before 1958 is in fac t subject to clearance under th e food additives amendment, a t which time they could come in and forestall appr opria te legal action by pressing for a n extension of the effective date of the amendment, de novo. This clearly would de feat the p ur­ pose of the law. There is clarif ying language th at would improve the bill as o rig­ inally dr afte d and subm itted to the Con gress : there are a few instances in which firms took timely action to determine the status of th eir pro d­ ucts under the food additives amendment, but final action on their requests for extension has n ot ye t been taken. To take care of such a situation, we recommend tha t H.R. 3980 be amended by adding on FOOD ADD ITIV ES 15 page 2, immediately aft er line 3, and on page 3, line 8, immediately aft er “1961,” the following, “or has on t ha t date a request for such extension pe nding before him. ” 4. Another safegu ard is the proposed requireme nt tha t before gra ntin g fur ther extensions we mus t find t ha t bona fide action was taken to determine th e a pplicab ility of the food additives amendment to the use for which extension is requested or to develop the scientific dat a necessary for action under the amendment. In the absence of such a provision, a firm th at had taken no steps to determine th at its products were in compliance with th e food additive s amendment could argue, when it learned th at the Government was investig ating its pro d­ ucts, tha t it should be gran ted a period of time in which to conduct studies of its own. 5. The bill would allow only those extensions tha t in our ju dgmen t are consistent with the objective of carr ying to completion in good faith , as soon as reasonably practicable, the scientific investigations necessary as a basis for action under the food addit ives amendment. 6. The bill would allow us to tenn inate an extension tha t we find should not have been grante d, one which was p roper when gr ante d but is no longer justified by changed circumstances, or one where there is fa ilure of the person who secured the extension to meet con­ ditions attac hed to it. H.R. 3980 would apply equally to a small group of agricu ltural chemicals (nematocides, pla nt regulators, defoliants, and desiccants) th at were food additives until Public Law 86-139 resulted in their being classed as pesticide chemicals in 1959. Unti l such time as the ir st atus can be definitely detennin ed, they should receive the same consideration as though they had not been shifte d from the food additive classification. The bill follows the patt ern of the color additiv e amendments of 1960 (Public Law 86-618) in tha t it leaves to us the decision as to how much time is needed to complete the testing of an additive. The time will vary for different products. Some it ems can be hand led within a few additio nal weeks or months, while some may require considerably more time. The plannin g and execution of the various tests contemplated by the food additives am endment is a time-consuming operation. In ou r own laboratories, for example, it takes approxi mately 3 years from the time we first decide to subject a chemical to chronic toxic ity t est­ ing until the results of the tests are summarized and available for adminisra tive review. And this assumes tha t n othin g unusual devel­ ops to require a repor t test or a more extensive investigation. To summarize, we now know t ha t if the food addi tives amendment becomes fully effective on March 5, 1961, it will seriously disru pt es­ tablished practices in the food indu stry tha t a re o f benefit to the con ­ sumer. There is no indicatio n th at such di sruptio n is required to p ro­ tect the public health. H.R. 3980 would permi t a more orderl y tra ns i­ tion to th e time when the food additives amendm ent is fu lly in effect, and, meanwhile, would p rotect the public hea lth by sound safeguards. The C hairman. Commissioner, thank you very much for your state ­ ment on the progress and status of t his i mpor tant mat ter before your Departm ent. We appreciat e having the testimony of you, Mr. Sec­ retar y, along with Commissioner Larric k. I thin k under the cir- 16 FOOD ADD ITIV ES cumstances, it would be ap prop riate , in view of yo ur statement, Mr. Secretary, to first recognize Mr. Thomson for any comment or ques­ tions he may have o f ei ther the Secretary or the Commissioner. Mr. T homson. No ; I have none. The Chairman. Mr. Si bal ? Mr. S ibal.. No, Mr. Chairman. The Chairman. I would say tha t obviously you were convincing. Mr. Willia ms? Mr. W illiams. Mr. Chairman, first, I would like to join t he c hair­ man a nd othe r members of the committee in welcoming our old frie nd Secretar y Ribicoff back to Washington . We look for ward t o work­ ing with you, Mr. Secretary, duri ng your term of office. I do not believe, Mr. Commissioner, th at you covered the suggestion made by Mr. Delaney rega rding the possible amending of this bill to do away with the so-called open-end app roach. Would you like to dis­ cuss that? Mr. L arrick. Air. Williams, if you and your committee are will ing to take this up again in 2 years, if it is necessary, on t he same rush basis t ha t you have this year, 1 would have no objection whatsoever to Mr. Delaney’s suggestion, and I have cleared tha t with my boss. Mr. W illiams. Do you feel th at it is necessary in order to pro­ tect the public interest ? Air. L arrick. I feel i f we were gi ven the au thority to decide it, we would decide it right , but I am not going to argue against Air. Delaney and Air. King. Secretar y R ibicoff. I think , Air. AVilliams, in talk ing with Mr. Larr ick—and you appreciate I would have to re ly a t th is st age on his judgm ent and experience—it is Air. Larr ick’s feeling th at a more realistic appr oach would be 3 years. However, I do apprecia te the fa ct of Congressman Delaney ’s efforts, because I do recall it was some 10 y ears ago when I was in Congress tha t Air. Delaney was fighting th is battle, and it was a lone fight by Air. Delaney in those days. AVe certainly have no objection to coming back he re 2 veal’s from now, and we would certainly defe r to the judgme nt of this commit­ tee, but the Food and Drug Commissioner and his Depart ment feel tha t 3 years would be more realistic. However, if there would be an inclination to write 2 years into the limitation, th at would c er­ tainl y be all right with the Departm ent. Air. Williams. I believe tha t is all, Air. Chairman. The Chairman. Air. Spring er? Air. S pringer. I do wa nt to welcome my old fr iend and next-door neighbor when he was in (he House to another job in Washington. Air. Commissioner, last year when we had this matt er up, and I do not know tha t it was anybody’s fau lt—it may have been lack of per­ sonnel or it may have been many other factors beyond our control— but the real concern in many of these instances was how long it was going to take in yo ur Depa rtmen t to get adjudicati on once a petition had been filed. If you would tur n to page 2 of your statement, you will notice the words: “We have received 319 petition s for food a d­ ditive regulations.” No, turn to th e fourt h item: “59 led to the issuance of regulations stat ing safe conditions for using the addil ves involved.” FOOD ADD ITIV ES 17 Would you please tell the committee approxim ately how many weeks or months or days there were from the tim e a petition was filed until there was an ad judicati on? Wha t was th e average length? Mr. Larrick. Mr. Sprin ger, tha t varies tremendously. Bear in mind tha t these petitions ordin arily are concerned with chemistry, they are concerned w ith pharmacology, and they are concerned wit h medicine; and routinely , if it trul y is a new chemical, it has to go throu gh all of our different divisions and they all have to give it very careful study, a nd sometimes these pet itions will be 6 inches thick. I would say tha t a t the be ginning it took us about 3 months to han ­ dle each petition. Mr. S pringer. In other words, this is an average of about 90 days ; is th at correct ? Mr. L arrick. Th at is an approxima tion, bu t as we gai n experience and as industry gain s experience in knowing w hat o ur scientists want in the petition, th e timel ag is getting progressively less. In other words, we are learni ng and indu stry is learning. Air. S pringer. Do you ultima tely hope you can decide these in ha lf th at time ? Air. L arrick. Some o f them. Very often, we have to send them back and say, “You do not have enough animal testing. ” Mr. S pringer. Are you findi ng any broad objection in the i ndus try as to the length of time involved in gett ing a djudic ation ? Mr. L arrick. I would say th at any Government agency always finds objections of people who want to get their problem solved immed iately; but, no, I would say in ge neral we are getti ng along very nicely w ith industry . Air. S pringer. Th at is all, Air. Chairman. The Chairman. Mr. Mack? Air. Mack. Than k you, Air. Chairman. I have no questions. The Chairman. Air. Schenck ? Air. Schenck. No questions. The Chairman. Air. Roberts ? Air. R oberts. Air. Chairma n, I would like to join one of our col­ leagues, Air. AVilliams, in welcoming our former colleague, Air. Sec­ retar y, to our committee. I am sure there will be many other a ppea r­ ances by the Secretar y and he can always find a warm welcome here in this committee. Ju st one or two questions, Air. Larrick . In your s tatement, at page 2 ,1 notice that you have 178 petitions now being actively e valuated. Air. L arrick. Yes, sir. Air. Roberts. Could you give us any estimate of how much more time you thi nk migh t be re quired to finish those 178 cases? Air. Larrick. T o finish all of them, Air. Roberts, will unque stion­ ably tak e 3 to 4 months, b ut some of them we hope to tu rn loose each day. On some of them, the scientists will say they have not done enough work on the liver of the ra t or they will say they are incom­ plete because of the chemistry, b ut the grea t bulk of them we hope to get processed within 3 months. I should add tha t once a man has filed a petition, even thoug h you did not extend t he Alarch 5 deadline, we would not tak e any action on tha t article in a legal way until afte r we had given the man our app raisal of the safe ty of his pr oduct. Once 18 FOOD ADD ITIV ES he has filed his petitio n and p ut it in, we do not take any action u ntil we have handled th at ma tter and decided it one way or the other. Mr. E gberts. However, it is your view tha t the 3-year extension would suit your purposes better than the 2 years ? Mr. L arrick. Yes, sir. Mr. Roberts. Tha t is all I have, Mr. Chairman. The Chairman. Mr. Younger? Mr. Younger. Mr. Larric k, it would seem to me if we are going to make an extension it would be wise to make an extension other than to March 1963. Here we come up to a sit uation with a new Con­ gress, and we are meeting on Feb ruar y 28, to consider an extension on March 6. Tha t to me, seems very unwise. Mr. L arrick. Mr. Younger, I could not agree with you more. Mr. Y ounger. It seems to me tha t the new Congress in 1963 may be up agains t the same kind of a n op eration tha t wTe have t his year. Mr. L arrick. I think you have a ve ry fine point. Mr. Younger. S o, if we are going to extend the time it ought to be extended into May or J une so as to give the committee adequate time to make a study before expiratio n. I certainly would recommend tha t the extension be made, rat her th an March, up until May o r June . Do you agree with that ? Mr. L arrick. Yes, I do, Mr. Younger. Mr. Younger. Thank you. Th at is all, Mr. Cha irman. The Chairman. Mr. Moulder ? Mr. Moulder. No questions. The Chairman. Mr. Avery ? Air. Avery. Than k you, Air. Chairman. Air. Secretary, I would like to associate myself with my colleagues in welcoming you to the committee. I did not have the pleasure of serving with you as a member of this body, but I look forwar d to serving with you in the legislative and admini strative relationship. Air. Larri ck, of course, we consider a standing consulta nt of this committee. Air. L arrick. Thank you, Air. Avery, I always have a good time up here. Air. Avert. I just have one question and this should be d irected to you, Air. Larrick . I think it is pret ty clear about the status of the 3,000 chemicals th at are pr esently listed as food additives. I am not so clear about the chemicals th at might presently be used and are not considered suspect at the moment as food additives , but m ight be so construed at a subsequent date. Our chairman touched on this jus t a little in his opening remarks. As I unders tand the bill, there is no provision fo r an extension of time in regar d to those possible suspect chemicals at all. If they subse­ quently should be listed as food additives immediately they would eithe r have to suspend the ir use or have it terminat e to the satisfaction of yo urself, tha t there were no c ancer-producing elements in them. Air. L arrick. Yon are quite righ t, Air. Avery. Air. A very. As I r ead the bill , the re is no provision in there. You suggested one amendment th at you were going to offer and as I heard you tha t would only apply to a chemical that is p resently pending on the date of the expiration of the time limit in the present statu tes. Air. L arrick. You are quite right. FOOD ADD ITIV ES 19 Mr. A vert. Ho we ver , you are no t su gg es tin g an y lan gu ag e th at wou ld giv e any co ns ide rat ion to thos e che mic als th a t m igh t so be de sig ­ na ted as suspe ct a dd iti ve s sub seq uen tly ? Mr. I jarrick. I t hi nk th at w hole p rob lem is too s pec ula tive to dea l wi th. I do no t an tic ip at e th at so rt of s itu at io n ar isi ng , ce rta in ly no t ve ry oft en in the fu tu re , an d I wou ld ha te to see th e bill com ple tely ope n-en ded for eve r. I t is conc eiva ble th a t w ith res pec t to some can lin in g o r some p ac ka gi ng ma te ria l w hic h we no w do n ot th in k g ets in to th e food, it m ig ht be p ossible th a t 10 y ea rs fro m now, we wo uld find th a t the food does abs orb it, bu t th en I th in k we wou ld ha ve to dea l wi th th at as it comes up. I re all y do n ot th in k, M r. Av ery , t h a t th er e is e nou gh pr ob ab ili ty o f th at prob lem ar isi ng . Mr. A very. Th en yo u wo uld oppo se lan gu ag e th at wou ld giv e con ­ sid era tio n to such ch emi cals ? Mr. L arrick. No, I w oul d no t sa y I w oul d opp ose it. I w oul d h av e to see it. I th in k it is i mp era tiv e th a t we ge t th is bil l t hr ou gh , b ecau se if we do no t ge t it th ro ug h by M arc h 6, th er e i s go in g to be chao s in t he foo d in du str y an d the n, Mr . Av ery , if we do find t h at th ere are some bug s in it, we w ill be the f irs t ones to co me up he re an d tr y to rec om ­ me nd wh at is th e f a ir thi ng to do. Mr. A very. I do not w an t to b ela bo r th is po in t, b ut if th e c om mit tee, in its jud gm en t, wo uld elec t to inc lud e suc h lan gu ag e yo ur d ep ar t­ me nt, if the lan gu ag e was in goo d stea d, wo uld no t oppose it? Mr. L arrick. N o. Mr. A very. Th an k you , Mr. C ha irm an . Th e C hai rma n . Mr. Fr ied el ? Mr . F riedel. I h ave n o qu esti ons , b ut I w an t to s ay th at I am gl ad to hav e you, Mr. Ribi coff, as Se cr eta ry of H ea lth , Ed uc ati on , an d W elf are . I did n ot ha ve th e p lea su re o f s er vi ng w ith you. I c ame in ju st a ft er you le ft, b ut I i nte nd to keep i n close tou ch w ith you . T h a t is all , M r. C ha irm an . Th e C hai rm an . Mr. Co llie r? Mr . C ollier. Mr . La rri ck , ju st to pu rsu e ve ry brie fly th e lin e of qu est ion ing of M r. Sp ri ng er an d Mr. Ro ber ts, did I un de rst an d you to sa y t h at wi th in 3 t o 4 mo nth s, you an tic ip at ed c lea rin g the 178 t h at ap pe ar on the l ist o f t hos e p eti tio ns t h a t ar e act ive ly being ev alu ate d ? Mr . L arrick. I w oul d say th a t fo r th e mo st p ar t, we wou ld be able to d ispo se of the m one wa y or an ot he r wi th in ab ou t 3 m ont hs. I do no t wa nt to be h eld to t h at t o the d ot beca use I hav e no t l ooked a t the de tai ls of all o f the m. Mr. Collier. I u nd er st an d t ha t. Th is, how ever , w ould ex clud e a ny of thos e the n th a t are be ing tes ted fo r ch ron ic tox ici ty ina sm uch as yo ur stat em ent s ays it w oul d ta ke up to 3 ye ars ? Mr . L arrick . Al l of thes e, s ir, hav e h ad th a t wo rk done. W e do no t do th e work . Th e law re qu ire d th at th e m an uf ac tu re r sub mi t to us a com plet e pro toc ol wh ich wi ll inc lud e th e ch em ist ry, the ph ar m a­ colo gy, the med icin e, an d ev er yt hi ng else inv olv ed, and pre su ma bly the se 178 have all h ad t h a t w ork d one, so th ey h ave alr ea dy u sed th ei r to 3 ye ars. Mr. C ollier. I s i t no t t ru e, how ever , th a t th er e ha ve been ins tan ces wh ere th e m an uf ac tu re r ha s mad e hi s sub mis sion of t hi s in fo rm at io n an d t he re has been a f u rt h er de lay in th e d ep ar tm en t in clea ranc e ? 20 FOOD ADD ITIV ES Mr. L arrick. You have to review th is mat erial with great care an d there are a grea t many of them to be considered. As we say, th ere are some thousands th at we have given extensions to and we have had to determine t ha t there was no undue hazard to the public health, so very obviously, duri ng this trans ition period, there have been delays. Mr. Collier. I point tha t out only to establish from my own reason­ ing th e need for more tha n 2 years then in this extension. Mr. L arrick. I will be content to abide by the judgm ent of this comimttee about the length of time, but I am very certa in tha t if we ju st get 2 years, we will be back asking for more time. Mr. C ollier. Th at is all, Mr. Chairma n. The Chairman. Mr. Macdonald? Mr. M acdonald. Than k you, Mr. Ch airman. I do not have any questions. I would like to join wi th my colleagues in welcoming Governor Ribicoff as our new Secretary of Healt h, E du ­ cation, and Welfare. I am sure this is just the be ginning of a very harmonious period o f time for both of us. Than k you, Mr. Cha irman. The Chairman. Mr. Devine? Mr. D evine. No questions, Mr. Chairman. The Chairman. Mr. Ja rma n? Mr. J arman. No questions. The Chairman. Mr. O’Brien ? Mr. O’Brien. N o questions, Mr. Chairman. The Chairman. Mr. Keith? Mr. K eith . I would like t o join with my colleagues in welcoming this new Secretary. I am very pleased tha t he has had experience in t he Congress a nd is ther efore, close to our problems with our con­ stituent s, the consumers, and the producers. I would like, just for the record, to remind him of the very serious problems th at atfect an indus try in the process o f determ ining what is a carcinogen. This gets to the root o f this whole question. In the case of the cranbe rry inciden t of a y ear ago, when we h ad tha t before the Congress, the p roblem was caused, not by t he adminis­ trat ion of the law by yo ur office, b ut by the definition of what was a carcinogen, and what could cause cancer in a human being. The fundamen tal question really is, Wha t is a carcinogen and wh at consti­ tutes a significant a mount of a carcinogen? And I thi nk there should be an effort to bring into the legislation the oppo rtun ity for the Secretar y of HE W to use reason and judgment. It does n ot now exist in the p resent law. Tha nk you, Mr. Cha irman. The C hairman. Mr. Moss ? Mr. Moss. I have one question, Mr. Chairman. Mr. Larr ick, you indicated th at the 2-year suggestion by Mr. De­ laney would be inadequate and stat ed a preference fo r a 3-year period. What is your best ju dgme nt as t o a realistic period for extending this in o rder to pe rmit you to accomplish all of the necessary testing now foreseeable ? Mr. L arrick. We are going throu gh a period of major read just­ ment in our food supply and I do not think anyone can honestly te ll you wit h ce rtainty how long it is going to take to get over this hump, FOOD ADD ITIV ES 21 but I am quite content to have 3 years if we could have it, or 2 ye ars, if we could have it, assuming tha t this committee will continue to show the active interest in this whole subject that they have always displayed in the past. Mr. Moss. However, you have no best judgme nt now as to the ap­ propr iate extension ? Mr. Larrick. I thin k we will have problems at least for 3 years. Mr. Moss. At least for 3 years ? Mr. Larrick. At least for 3 years. Mr. Moss. Those are all the questions I have. The Chairman. Mr. Thomson, do you have any questions now ? Mr. Thomson. No. The Chairman. Mr. Dingell ? Mr. Dingell. Thank you, Mr. Chairman. I would like to commend and to compliment the distinguished Secretar y for coming up here. I had an o ppor tunit y to meet with him earlie r and I had an oppo r­ tunit y to learn how busy bis schedule is, and I would like to express my personal thanks to him for making available this time in what I know to l>e an almost desperately busy schedule. With the permission of the C hair, I would like to treat two th ings with Mr. Larrick. The first, Mr. Larrick, has to do with a question asked by Mr. Avery. I refer specifically to the discovery of something which may not previously have been regarde d as an additive, on evidences found by the Food and Drug, or by independent research­ ers to show that this happ ens to be in effect an additive, or a previously harmless substance now shows that it mi ght perh aps be harmful. Is it not a fact that there is, withou t this partic ular legislation, adequate aut horit y for the Food and Drug Admin istration to require analysis, examination, and studies to be made which would be ap­ propri ate to protect the public interest in those instances ? Air. Larrick. Quite righ t, sir. Mr. Dingell. And this bill does not tre at with t ha t at all ? Mr. Larrick. No. Air. Dingell. And there is no reason why it should ? Ah’. L arrick. I do not think it needs to be treated . Mr. D ingell. We have been talkin g about time limits on this. As you p erhaps gathered, a number of us in the Congress are very much concerned about the possibility of a blank check extension, even though we regard your efforts and the efforts of your agency very highly. It you were to get 3 years, is there any reason present today t o infer tha t you would not be able to accomplish the great bulk o f the work tha t is imposed upon you by the law rig ht now ? Air. L arrick. No. Three years would tak e care of the gre at bulk of it, Air. Dingell. Air. D ingell. Say we were to go to as far as 4 years. Would we be reasonably sure that that would be adequate to accomplish the whole thing? Air. L arrick. Fo r all pr actical purposes, yes. There may be a few left over that we would not have th e answer to in 4 years, but certainly the grea t bulk of them ought to be dis­ posed of. Air. D ingell. The reason I talk about 4 yeai's is that 3 y ears is enough for a good dog test, is that not r igh t? " 6 6 7 3 8 - 61------4 22 FOOD ADDITIVES Mr. L arrick. Yes. I think Mr. Younger has a very good point when lie says that, it ought not to expire righ t at the beginning of a new Congress, and make an emergency if we do have to come back up. Mr. Dingell. For th is reason, you would suggest 3 ins tead of 4, so we could look at it more ca refully? Mr. L arrick. And make it expire later in the year instead of in March. Mr. Dingell. Assuming you were then to say fix it at some time other tha n March, pu t it back, say to J une, would t his lie bette r still ? Mr. L arrick. Yes, much. Mr. D inoell. Thank you, sir. Than k you, Mr. Ch ainna n. The C hairman. Mr. Sibal ? Mr. S ibal. Mr. C hairman, I ha ve no questions, but I would like to take this oppor tunity to state how happy I am tha t circumstance has permit ted my path to cross with Secretary Ribicoff again. 1 am afr aid it will t ake me a while to learn to call him Secretary and not Governor. The Chairman. Mr. Rogers? Mr. R ogers of Florida . Mr. Chai rman, just a question or two. Of course, I want to join in greeting the Secretary and his dis­ tinguished stall' here, and we are particu larly pleased to see Mr. La r­ rick here and also Jim Quigly. We are all delighted to see he is now in your Department. Concerning some of the questions, Mr. Larrick, that Congressman Dingell mentioned about the necessary author ity for you to inquire into products, I happen to have a m atter that I took up with the De­ partm ent in Jan uar y concerning, and I will not identify it, a cosmetic application. The people who had bought the product were concerned because it ha d no clearance on its labeling from Food an d Drug, and so fort h, and so they wrote to see if there were some way they could find whe ther this application would be safe to use before they actu­ ally used it. The reply I received back from the Department of Health , Educa ­ tion, and We lfare was that, first of all— The Fed eral Food, Dru g and Cosmetic Act ap plies to the saf ety of the prod uct and its labeling. No prio r clea ranc e is requ ired by law. We have received no com plain ts o f adve rse r eac tion s from its use. And you h ad none and they gave no adverse reaction because they had not yet used it. This next sentence is what concerns me: Inf orm atio n as to compositi on has been refuse d by th e ma nu fac tur er and since we have not found significa nt claim s in the labeling we have not had occasion to a nal yze the produ ct. Wh at I want to know is, Do you have necessary auth ority when a request is made like thi s to determ ine whether the products in a cos­ metic applica tion are safe enough? Do you have au thorit y to ask the man ufac turer to at least let you know what is in th at product, or not ? Mr. L arrick. We have autho rity in the case of cosmetics to ask him, but we have no power to require him to supply the information , and we a re plann ing with the consent of the Secretary, to send up to thi s committee durin g this Congress, broad au thority to do factory inspec­ tion and to get just that information . FOOD ADD ITIV ES 23 Air. R ogers of Fl orida. Is this a normal practice for m anufac turers to refuse to give you such informati on? Mr. L arrick. No. I would say tha t the grea t bulk of the man u­ facturers, in spite of the fact tha t there is no compulsion to give it to us, except in certain instances, do give it to us vol untarily, but 1 think tha t the Government should have the power to require that sort of in­ formation in prote cting the public health. Mr. R ogers of Flori da. My present feeling is tha t I certainly agree with you and I would be interested to follow this up. Secretary Ribicoff. I am in favor of tha t type of legislation. I usually find that legitimate manufa cturers who are reputable never object to coo perating and those tha t are questionable usually do, and the questionable ones are those t hat raise the problems for the con­ sumer and for the con stituents who want to make sure they are doing the righ t thing. Wo are going to send up legislation and we would hope t ha t this committee would give it their most favorable consideration. It is something that the Departmen t has taken up with me. Mr. R ogers of Florida . Tha t is tine. Thank you. The Chairman. Mr. Hemphill ? Mr. II empiiill. I have one question of Mr. Larrick. If t his committee saw fit to put a time li mitati on of 3 years, would the mechanics be accomplished by adding to the bill on page 2, line 6, afte r the words, “effective date,’’ the words “not later than May 6, 1964” ? Would tha t accomplish it? Mr. Larrick. I believe it would, sir. Mr. II empiiill. Thank you very much. The Chairman. Mr. Rostenkowski ? Mr. R ostenkowski. I have no questions, Mr. Chairman. The Chairman. Mr. Roberts? Mr. R oberts. With reference to th e suggestion you made, Mr. L ar ­ rick, for adding additional language afte r line 3, page 2, and pa ge 3, line 8, I would like you to elaborate on what you consider meets the test of bona fides on the part of the indus try ? Mr. L arrick. If the indust ry person o r firm has diligently sought to complete this complicated testing that is required but the time was not sufficient to let him complete i t—something went wrong with the test, or it took more time than they thought was required—1 would think tha t tha t would pass the test- Also, in the case of some additives a l iter atu re search is a tremen­ dously involved and time-consuming m atter, and if they could show tha t they diligentl y tried to search th e liter atu re of the world, to see whether or not this chemical is either safe, or g enerally recognized as safe, or proven safe by previous tests, I would be inclined to let them have the advantage of the extension. Mr. R oberts. Suppose you have an add itive t hat has generally been considered to lie safe. Then in the light of new scientific knowledge, it moves into the suspect area. What k ind of a test would you apply to tha t parti cula r indust ry ? Mr. L arrick. If it moved into the serious suspect area, Mr. Roberts, my disposition would be to stop its use. If you have a real problem of public health, a real, serious question of inju ry to the public h ealth, I would stop its use until they had done w hatever amount of testing is necessary to clear it. 24 FOOD ADD ITIVE S I would resolve the question in fav or of the public heal th. I do not thin k th at will happen very often. The Chairman. Mr. Keith? Mr. K eit ii . Mr. Larric k, you mentioned th at if a p artic ular chemi­ cal became suspect, you would recognize t hat fac tor in yo ur adminis­ trat ive course of action. Wh at about the chemical which by use gr ad­ ually is found to not be a carcinogen ? Wha t action do you take to look out for the consumer and indus try protection there? Mr. L arrick. Mr. K eith, I would say tha t in all the administra tion of this act, and all other acts perhaps, we should employ the rule of reason an d resolve the quest ion in favor of the pub lic healt h, b ut not conjure up artificial suspicions to do harm to the industry. Mr. K eith . T o the liest of your knowledge, has th ere been any rea­ son to believe or suspect tha t any cancer has been induced by the con­ sumption of cranber ries at any time ? Mr. L arrick. We produced a cancer of the thyroi d in animals, but I do not have any evidence tha t it produces cancer in man. I want to forg et about the cranberries now. Mr. K eith . I would like to correct your testimony. It, was no t cranberri es tha t caused the cancer. Mr. L arrick. That is right. You are right. Mr. K eith . I do not believe that your research will ever reveal tha t cranberrie s were a vehicle for amino to the extent tha t any cancer resulted, anyway. Mr. L arrick. Mr. Keith, we gave cranberries a clean bill of health. Mr. K eith . Costing nevertheless, the industry a tremendous amount of money. Thank you, Mr. Chairman. The C hairman. While you are on th at subject, I am constrained to inquire if you gave chickens a clean bill of health. Mr. L arrick. We sure did. The C hairman. Mr. Secretary, you mentioned it in your statement, but I think it would be appr opri ate to emphasize the fact tha t this bill extends your auth ority to certain food additives and certain pesticide chemicals. I am somewhat of the opinion tha t most people feel that th is bill relates only to food additives. I wanted to emphasize just what it does. Section 2 o f this bill, II.I \. 3980, ha s to do with the extension of this auth ority as fa r as it is applicable to food additives, is that not true? Mr. L arrick. That is correct, sir. The C hairman. And section 3 so fa r as its applic ation is concerned, would be to pesticide chemicals? Mr. L arrick. Let me expla in that if J may. The Chairman. All right. Mr. L arrick. When you handled the pesticide chemical bill, in 1954, I believe it was, it just covered certain types of pesticides. It did not cover the articles mentioned at the top of page 3, which are not things that kill bugs. The agri cultu ral chemical people preferred to have all of the articles of this typ e tha t are used in agricu lture handled under the pesticide bill, rat her than having part of them under pesticides and pa rt of them under food additives, so they went to the Agr icultu re Committee FOOD ADD ITIV ES 25 wi th whom the y no rm all y do busi ness , an d the y go t thes e sub stan ces th at are lis ted th er e at the top of pa ge 3 dec lare d to be pe sti cid e chemi cals. Th ere is no lon ger au th or ity fo r de fer me nt s un de r th e pe sti cid e bill. We t ho ug ht i t onl y fa ir to g ive th em th e same o pp or tu ni tie s fo r de fer me nt the y wou ld hav e rece ived if the y ha d rem ain ed foo d ad di ­ tives . Th e C ha irm an . I th ou gh t h at th at sho uld be clea red up or un de r­ stood . Tind er the pro vis ion s of th e bil l, th e Se cr etar y coul d g ra n t an extens ion of tim e if he finds th a t (1) th er e is a bon a fide ac tio n to det erm ine th e ap pl ic ab ili ty of th e foo d ad di tiv e law to a pa rt ic ul ar subs tanc e th a t was comm ence d be for e M arc h 6, 1960, a nd was th er e­ af te r pu rsu ed w ith rea son abl e dil ige nc e; (2) an d he had ad di tio na lly gr an te d an ext ens ion to Ma rch 5, 1961; an d (3) a fu rt her ext ens ion of tim e is nec ess ary to com plete scie ntific inv est iga tio ns. Those are th e lim ita tio ns on yo ur D ep ar tm en t w ith ref ere nce to th is pro po sal ? Mr. L arrick. Ex ac tly . Th e C ha irm an . W ha t wou ld ha pp en , as Mr . Ro ber ts me ntio ned a mom ent ago, if th er e was a sub stan ce th a t ha d no t been con sid ere d to bo a foo d ad dit ive a nd ye t, b y so me d eve lop me nt or becau se o f s ome­ th in g th at m ig ht h ap pe n, it w as sud den ly de ter mi ned th at th is was a food ad dit ive ? W ha t woul d hap pe n to th a t sub stan ce? Mr. L arrick- A t th a t sta ge, Mr. Ch air m an , it would become the Respon sibility of both th e m an uf ac tu re r an d th e Gov ern me nt to tak e a look at t he qu est ion o f wh eth er or n ot i n th e am ou nt th at th is p ro d­ uc t a pp ear s in th e fo od it is safe or har m fu l. I f a conc lusi on cou ld be re ach ed th at it i s saf e, the n no th in g wou ld ha pp en . I f a con clus ion was rea che d th a t it was ha rm fu l, it wou ld hav e to g et o ut o f th e f ood su ppl y. Th e C hai rma n . W ou ld th ere be an y tim e to det erm ine w he the r or no t i t wa s sa fe o r h ar m fu l ? Mr. L arrick. Th er e wou ld be no tim e if it was defi nite ly show n to be h arm fu l. Th e C hai rm an . O f course , if it was def ini tely s hown t o be h ar m fu l you wou ld n ot need an y t ime. Mr. L arrick. T h at is r ig ht . I f it was unk now n, the n we wou ld ha ve to giv e time to find out whi ch is rig ht . Th e C hai rm an . Cou ld you giv e tim e un de r th is pro vis ion ? Mr. L arrick. I th in k th a t we wou ld ha ve th e ad m in ist ra tiv e au ­ th or ity to be rea son abl e in th e m att er. Th e C ha irm an . Mr. Se cre tar y, may I th an k you and Mr. Lar rick fo r yo ur ap pe ar in g her e th is m or ni ng an d yo ur testi mon y. W e ap ­ pre cia te yo ur br in gi ng wi th you yo ur sta ff an d pre sen tin g eac h of the m t o th e m emb ers o f th is comm ittee. Se cre tar y R ibico ff. Tha nk you ver y muc h fo r th e cou rtes y of yo ur sel f and th e com mitt ee, an d we will look fo rw ar d to bei ng her e fre qu en tly in th e ma ny mo nth s ah ead . Th e C hai rma n . Th an k you. Mr . L arrick. An d I enjo yed m ysel f. 26 FOOD ADD ITIVE S The Chairman. Thank you. We are glad to have you back, Mr. Commissioner. We look forwa rd to seeing you he re again, too. We have two witnesses from out of town. Mr. Boyd, I observe that you a re from New York. We are going to hear you rig ht now. ST AT EM EN T OF GEORGE BOYD, JR ., COUNSEL, AM ERI CA N PA PE R & PU LP ASSOC IATION , NE W YORK, N.Y. Mr. Boyd. Mr. Cha irman and members of t he committee, my name is George Boyd, J r. I am a member of the law firm of Dunnington, Bartliolow & Miller, in New York City. We are counsel for the American Pap er & Pul p Association, the overall nati onal association for the p aper and p ulp indust ry, with which I believe all of you gen­ tlemen are thoroughl y familia r. I think you have before you the statem ent which we have prep ared on behalf of the American Paper & Pu lp Association, the first page of which sets fort h briefly the thoug hts of t he pulp and pape r indust ry concerning H.R. 3980. Appended to this is a more detailed explanation of our proposed amendment to t he bill. Gentlemen, may I make it pe rfectly clear th at the p ulp and paper industr y sup ports H.R. 3980. The one point that I would respectful ly make to the Committee on Inte rsta te and Fo r­ eign Commerce is tha t in the lette r trans mitt ing the proposed bill to th e committee, and to the Sp eaker of the House, and the Presiden t of the Senate, it was suggested that legislation is desirable to ascertain whether the food additives amendment applies to the substance? involved at all, and it is my unders tandin g tha t Secretary Ribicoff. the able Secretary of Healt h, Education , and Welfare , has endorsed the request by the former Se cretary. The question has been raised before the committee this morning as to what would ha ppen in the case of substances which presently are generally recognized as safe or substances which the Food and Drug Admi nistrati on has prio r sanctioned, both of which categories under the food a dditives amendment a re exempt. The fa ct of the ma tter is, gentlemen, under H.R. 3980, as it is p resently draf ted, afte r March 6, 1961, if a substance would be determined to be oth er th an generally recognized as safe or if the prio r sanction were taken away, but it would be considered by Food and Drug to be safe, the Secretary and the Commissioner of Food and Dru g would not legally have any auth ority to gra nt an extension of time during which the Food and Drug Admin istration and the affected industry or companies could ascertain what tolerances might be required, if any at all. In other words, absent the provision tha t we have recommended in th e attached bill to our st atement people would be put in (he posi­ tion of requesting the Food and Drug A dministr ation to perform an act u nauthoriz ed by law, and we cer tainly have had the most friendl y and cordial, and helpful relation ship with the able Food and Drug Admi nistra tion both on the admin istrativ e and technical side, and I thin k it undesirable to put any Government agency in a position where they may not exercise autho rity by benefit of law. I thin k this pret ty much covers, Mr. Chairman and gentlemen, the views which I have to express on behalf of the industr y, except that I would like to state that as fa r as paper and paperbo ard for food packagin g purposes are concerned, they have been used for 60 years FOOD ADD ITIV ES 27 and there is no case of record where th ere has ever been any illness caused by any migrati on or tra nsfe r, and in the opinion of competent scientists, pap er and b oard for food pa ckaging purposes are not food additives as defined in the law. If Mr. Muldoon could have his 25 seconds, Mr. Harr is, I would be most grateful , sir. (Mr. Boyd’s statement follow s:) Statement of American P aper & P ulp Association The forme r Sec reta ry of HEW, in a let ter to Spea ker Raybu rn, urge ntly re­ queste d the e nact men t of a hill to remove the time l imi tati ons for dis cre tion ary extens ions unde r the food add itive s law, so th at FDA and affected ind ust ries will have more time to determ ine, among oth er thing s, “whe ther th at law appl ies to the subs tanc es involved at all .” Sec reta ry Ribicoff has ful ly en­ dorsed this r equest. Affected ind ust rie s agre e with the Secr etary th at it is essen tial to provi de add itio nal time to dete rmin e the appl icab ility of the law to a pa rti cu lar sub­ stance. The bill submit ted, now H.R. 3980, does not accomplis h this. II.R. 3980 un­ necess arily limits the Sec reta ry's au tho rit y to gr an t exten sions to sit ua tio ns where pr ior exten sions h ave been given. Ther e are a gre at many subst ance s now “gene rally recognized as sa fe ” or th at have received prio r sanc tion s for use. If in the fu tu re the s tat us of thes e subs tanc es should chan ge for any reason (and thi s has occurre d in the pa st ), add ition al time would lie requ ired by FDA and affected ind ustr ies to develop scientific dat a for a requ ired regu latio n. Under II.R. 3980 the Secr etary would be pow erless to gr an t such addi tion al time af te r March 0, 1901. It is extre mely imp orta nt th at thi s deficiency lie co rrected . A bill to accomplish this, toge ther with a more deta iled expla natio n, is atta che d. A Substitute B ill for H.R. 3980, the P roposed F ood Additives T ransitional P rovisions Amendment of 1901 A dra ft bill ent itle d “Food Additi ves Tra nsi tio nal Provis ions Amendme nt of 1901,” to gethe r with accompa nying let ter and exp lan ato ry mat erial , was tr an s­ mitte d to the Spea ker of the House of Rep rese ntat ives on Jan ua ry 13, 1901, by the forme r Secr etary of Hea lth, Educ ation , and Wel fare. The dr af t bill was intro duce d as reque sted, and is now before the Commi ttee on In te rst at e and Forei gn Commerce as H.R. 3980. The basic con cept of thi s proposed legi slati on is the removal o f t he tim e limi t o f Ma rch 0, 1901, which now e xist s with res pec t to a food addi tive in commerc ial use before Ja nu ar y 1, 1958. The au tho rit y of the Secre tary of Hea lth, Educ ation, and We lfar e to postpon e the effective da te of the Food Additi ves Amendme nt of 1958 for such food addi tives und er th e proposed legisla tion, and unde r the pres ent law, can only be exercised when the re is no undue risk to the public hea lth and cond ition s exist nec essi tati ng the pre scribin g of a n addi tion al period. As indica ted in th e let ter of tra ns mi tta l to Spea ker Rayb urn, legi slat ion to exte nd the disc reti ona ry jieriod for the Sec reta ry to gr an t extensi ons is requ ired both by the Food and Drug Adm inis trat ion and by affected ind ustr ies becaus e the Food and Drug Adm inis trat ion cann ot phys ically process petit ions und er the food addi tives amen dmen t before March G, 1961—the pres ent cutoff da te on the a uth ori ty of the Sec reta ry to gra nt exten sions—a nd because affecte d in­ dus trie s canno t possibly develop all nece ssary scient ific dat a, infor mati on and peti tion s before th at d ate. H.R. 3980 does not fully meet the needs of the p res ent situ atio n. As poin ted out in the form er Sec ret ary ’s lett er, the add itio nal au tho rit y conf erred by the hill is not only nece ssary in o rder to p erm it th e c ompletion of inqu iries or s tud ies to deter mine the saf e use of an add itiv e und er the food add itive s amen dmen t, but also to perm it nece ssary time in which an int ere ste d pa rty might d eter min e “wh ethe r t ha t la w a ppli es to the subs tanc e invol ved a t a ll.” The languag e in sectio n 2 of H.R. 3980 is unneces saril y res tric tiv e on the dis­ creti on of the Secre tary. It is inco nsist ent with one of the sta ted purp oses of the bill in th at it would res tri ct his au tho rity to gr an t nece ssary and des irab le exten sions only to those s ubst ance s which were food a ddi tiv es in commercial use 28 FOOD ADD ITIV ES before Ja nu ar y 1, 1958, and the n only if an exten sion had been gra nte d prio r to March 6, 1961. It is a known fac t th at the re ar e many subst ance s which ar e now gener ally recognized as safe by quali fied scientific exp erts and which are c onsequ ently not food add itiv es with in the meani ng of the Food Additiv es Amendm ent of 1958. It is ent irel y possible th at some of thes e a t some fut ure time will no longer be so recognized. In such event, time will be requ ired for the prom ulga tion of an app rop riat e reg ulat ion governing the condi tions und er which the food addi tives may be used. It se ems only fa ir th at so long as the Sec reta ry finds the re is no undue ris k to the public hea lth he should be p erm itte d to gr an t s uch time. The Secr etary und er the pres ent langu age of II.I t. 3980 would be i>owerless to gra nt such add itio nal time. This is ju st one ar ea in which problem s would be crea ted by the pre sen t section 2 of the bill. The same arg um ent would apply equally to subs tanc es which were sanc tione d by the Food and Dru g /Administration pri or to ena ct­ ment of the food add itiv es ame ndm ent on Septem ber 6, 1958. Such sancti oned items are pres entl y exemp t und er the law. However, if any of such sanct ions were to be with draw n, the user would be in the position of havi ng a food add i­ tive in violat ion of law, wit hou t reco urse to the e xtensio n procedu re. Theref ore, section 2 o f H.It. 3980 should be amended to e nlar ge the di scret ion of th e Sec reta ry to gra nt exte nsion s n ot only wit h respe ct to food add itiv es com­ mercia lly used before Ja nu ar y 1, 1958, bu t also wit h respect to subs tanc es now conside red exemp t und er the law, but whic h at some fu tur e dat e may be con­ sidered a food add itiv e requ irin g ap pro pri ate regu lati ons pres cribi ng conditi ons unde r wh ich t hey may be safel y used. In summ ary, the Sec reta ry’s au tho rit y to gr an t extens ions should encompass not only subs tanc es now known to be food add itiv es but also thos e subst ance s for which add itio nal time may be requ ired to determ ine the appl icab ility of the law. A bill to accompli sh t his is s ubm itted here with . A B IL L To am en d th e tr a n si ti o n a l pr ov is io ns of th e A ct ap pr ov ed Se pt em be r 6, 195 8, en ti tl ed “A n Ac t to p ro te ct th e pu bl ic h ea lt h by am en di ng th e F ed er al Fo od , D ru g, an d Co sm eti c A ct to p ro h ib it th e us e in fo od of ad d it iv es wh ic h ha ve n o t bee n ad eq ua te ly te st ed to es ta b li sh th e ir sa fe ty ,’’ an d fo r o th e r pu rp os es . Be i t enacted by the S enat e and House o f Re pre sen tati ves of the United Sta tes of Ameri ca in Congress assembled, Th at th is Act may be cited as the “Food Additiv es Tr ans itio nal Prov ision s Amend ment of 1961.” Sec. 2. Subsectio n (c) of section 6 of the Food Additiv es Amend ment of 1958 (Publ ic Law 85-929, 72 Stat . 1784, 1788) is amen ded (i) by dele ting the words “if such use was made of s uch add itiv e b efore J an ua ry 1, 1958” a nd sub stit utin g ther efo r the word s “if the subs tance s mak ing up such add itiv e were sim ilar ly used before Ja nu ar y 1, 1958,” and (ii ) by ins ert ing in such subsec tion, at the end thereo f, the followi ng : “No twi thst and ing th e par enth etic al time lim itat ion in claus e (1) (B) of thi s subsection, the Sec reta ry may exte nd such effective dat e und er the au tho rit y of th at claus e (bu t sub ject to clause (2 )) wit h respe ct to such use (or a more limit ed specified use or uses there of) if, in add itio n to makin g the findings requ ired by clau se (1) (B) he finds t ha t bona fide a ction to dete rmin e the a ppli cabi lity or inap plic abil ity of such section 409 to such use or uses, or to develop the scientific dat a nec essa ry for action und er such section, was commenced by an inte rest ed perso n and is being pursu ed wit h reaso nable diligence. The Sec reta ry may a t any time ter mi na te an extensi on so g ran ted if he finds th at it should not have lieen gra nte d or th at by reason of a change in circ ums tanc es the basi s for such exte nsio n no longer exists , or th at the re has been a fa ilu re to comply wit h a requ irem ent for submission of prog ress rep orts or with oth er cond itions att ach ed to such exte nsio n.” Sec. 3. Pa ra gr ap h (b) of section 3 of the Nematocide, Pl an t Reg ulato r, De­ folia nt, and Desi ccan t Amendm ent of 1959 (Pub lic Law 86-139, 73 Stat . 286, 288) is amended by ins erti ng in such par agr aph , at the end there of, the follow- ing : “When ever the Sec reta ry of Hea lth, Educ ation , and We lfare has, pu rsu ant to cla use (1) of thi s pa rag rap h (b ), pres crib ed an add ition al perio d exp iring on March 5, 1961, wit h respe ct to any such pa rti cu lar use of a nemato cide, pla nt regu lator , defo liant , or desic cant, he may, not wit hsta ndi ng the provisi on to the con tra ry in such clause (1 ), fu rth er exten d the exp irati on da te appli cable und er such clau se (1) , (bu t subj ect to clau se (2 )) with respe ct to such use of such subst ance (or a more lim ited specified u se or uses the reo f), if, in ad diti on to making the findings requ ired by c lause (1 ), he finds (A) th at bona fide action to dete rmin e the appl icab ility of such sectio n 408 to such use or uses, or to FOOD ADDITIVES 29 develop the scientific dat a necessary for action under such section, was com­ menced by an intereste d person before March 6, 1960, and was ther eaf ter pur ­ sued with reasonable diligence, and (B) tha t in the Secreta ry’s judgment such extension is consistent with the objective of ca rrying to completion in good f aith, as soon as reasonably practicable, the scientific investigations necessary as a basis fo r action u nder such section 408. The Secret ary may a t any time term i­ nate an extension so grant ed if he finds tha t it should not hav e been grante d, or th at by reason of a change in circumstances the basis for such extension no longer exists, or th at there has been a failu re to comply w ith a requirem ent for submission of progress report s or with other conditions attache d to such extension.” The Chairman. Y ou may identify yourself. STA TEM ENT OF THOMA S J. MULDOON, TE CH NIC AL DIR ECT OR, NA TIO NA L PAP ERB OA RD ASSO CIATI ON Mr. Muldoon. Yes, sir. My name is Thomas J. Muldoon and I am the technical directo r of the National Paperb oard Association. The National Paper board Association concurs with the American Pap er & Pulp Association in its feeling t ha t th e F ood an d Dru g A d­ minist ration should have the necessary power to gran t extensions, especially in situation s where a material 'which is now not, th at is, before next week’s extension, considered to be a food additive or subsequently held to be one. This materia l, as well as th e materia ls now on extension, would need a time extension in which to prove its safety. I understan d there are pres ently 700 mate rials which are generally recognized as safe and also a very large number of materials being used under pri or sanctions, and we feel th at provision should be made to cover the contingency t ha t one o f these material s is removed from its current status. Thank you. The Chairman. Mr. Boyd, when I asked Commissioner Lar rick the question as to what would happe n, I understood his response to be th at if such a condition were to arise, he thou ght under this bill, or u nder t he existing law, the Food and Dru g Adminis tration would have regulato ry a utho rity to deal with the subject. You say tha t they would not under th is bill. Mr. Boyd. Mr. Chairman , I would say unde r this bill, much as I respect the able Commissioner, th at it would be an extralegal act by the Food and D rug A dminis tration to gra nt an extension af ter March 6,1961, to a substance which had not pre viously been considered to be a food additive by reason of being generally recognized as safe or enjoying a prior sanction status. Mr. Avery. Mr. Chairman , I have a question there. I though t I asked Mr. Larr ick essentially the same question as you did and got a different answer. I understood Mr. La rrick in response to my question to say he had no autho rity to g ran t an extension of tim e for testing, if it became suspect and then in response to you, he s aid tha t he would have sufficient discretion in tha t matter. Could we have Mr. Larrick clarify that response for us? The Chairman. I would like to get it cleared up, Commissioner. Mr. L arrick. I did n ot thi nk I was doing any doubletalk. The Chairman. I am sure it was not intended, if you did. Mr. A very. I did not mean to so infer, but I was confused. 30 FOOD ADD ITIV ES Mr. L arrick. No. If an article were found to contaminate food and it were shown th at the articl e is har mful to human beings, or is highly suspect—I mean highly suspect so tha t you can’t determine whether it is going to do harm —I thin k the n i t would be our obliga­ tion to take it out of the food. On th e other hand, under the circumstances th at Chairm an Ha rris refer red to, where you suddenly discover tha t an article tha t you thou ght did not m igrate i nto a fo od and you had no fa cts other than the fact tha t a small amount of it migrated into the food, and you did not have any reason to be h ighly suspicious of it, I thin k tha t, as Commissioner of Food and Drug, I have th e admin istrativ e rig ht to do the fai r thin g and perm it time to elapse to test it. Have I cleared up my answer ? The C hairman. Y ou have in my mind, so fa r as y our own position is concerned, b ut let me ask it this way for the record, and I think this is impor tant. It is true th at there are many substances now generally recognized to be safe. Mr. L arrick. A grea t many. The Chairman. There are many substances that have received pri or sanctions for use. Mr. Larrick. Th at is right. The Chairman. N ow, suppose th at a substance th at has generally been recognized as safe, or th at has received prio r sanctions from you, at some future date becomes suspect. Would you then have auth ority, in your opinion, under the law and the extension und er this bill, to give time for that suspicion to be resolved ? Mr. L arrick. Mr. Harr is, I thin k t ha t would depend on th e degree of suspicion of the article. If it were a grave suspicion, I do not thin k the American public should be subjected to that. The Chairman. The point is if you already determined it was unsafe, then its use must be discontinued. Mr. L arrick. Th at is right , a nd i f we do not know, I thi nk we have the auth ority to let them test it. The C hairman. If it becomes suspect and a final de terminat ion has not been made you would have auth ority then to have them test it? Air. L arrick. I thin k so. Mr. Younger. Mr. Chairman, may I ask a question ? The Chairman. Yes. Air. Younger. Mr. Larri ck, as long as there is some doubt as to whether you have the auth ority or do not have the auth ority, do you have any objection to clearin g th is up and making sure t ha t you do have the autho rity ? Air. L arrick. I never object to anyth ing that this committee does- The C hairman. Th at is a very broad statement. Air. L arrick. When this committee speaks, we follow. I do not think it is necessary, Air. Younger. Air. AIoulder. You say you have the author ity, but under what provision of the law do you base your au thorit y ? Air. L arrick. I thin k I have admin istrativ e dis cretion t o apply the rule o f reason to ev erything th at we do in Food a nd Drug, and I do not thi nk t ha t we should lower the boom on a mere suspicion. I think we ought to have more than a suspicion. Mr. AIoulder. Can you point out the specific p rovision of the law which gives you the authorit y ? FOOD ADD ITIV ES 31 Mr. L arrick. No. The Chairman. Could you supply tha t ? Mr. L arrick. We could supply you some S upreme Court decisions th at say tha t an adm inistr ator of a Feder al law is supposed to use commonsense and apply the rule of reason. Th at is about as fa r as we could go. The Chairman. Mr. Boyd, does that sa tisfy you ? Mr. Moss. Would you yield at tha t p oint, Mr. Younger? Mr. Y ounger. I do not have the floor. Mr. Moss. Mr. Chairm an? The C hairman. Mr. Moss. Mr. Moss. I have been tryi ng to figure out jus t wh at we would be discussing by inference here i f it is not now regard ed as an a dditive or as an add ition of any ty pe potentia lly dangerou s, and at some sub­ sequent date it would become so regarded. There would have to be something occur upo n which you would base the conclusion t ha t it would even require examination, and I assume th at you would hav e to have other than just a suspicion. You would have to have some medical evidence before you ? Mr. L arrick. Th at is rig ht. Mr. Moss. Before you would feel tha t it should be included a t all? Mr. Larrick. Tha t is right. Mr. Moss. And so we are in a very highly speculative field an d to cover th at it would be difficult to dr af t language, would it not, unless we gave you bla nket autho rity in perpe tuity to gra nt extensions fo r any reason ? Mr. L arrick. I have great respect for this gre at industry th at is represented here today, but they have not had experience with the adminis tration of th e p ure food and drug law. It is new to them. Mr. Moss. It seems to me t ha t is as far as we can go on at this point. Mr. L arrick. I thin k they are worried about something th at is not likely to happen. Mr. Moss. In re ading the lan guage here w hich was proposed by the witness who just lef t the stand, I am intrig ued with the change in verbiage in section 2 prop osing tha t we delete th e words “if such use was made of such additive before Jam iary 1, 1958,” and substit uting “if the substances ma king u p such addit ive were sim ilarly used.” They could be similar ly used, but in an e ntirely differe nt combina­ tion, could they not? Air. L arrick. Tha t is right . Air. AIoss. In this day and age where we do some very interes ting thing s in remaking from the same substances diff erent products, the rearran gement of the substances m ight produce an entirely different type and potentiall y very lethal produ ct; yet we would be going in to an indefinite period of extension. 7 Air. L arrick. Th at is right. Air. AIoss. It is r ath er interes ting language in t ha t it Opfcns a very broad door here. Air. L arrick. Yes, I thi nk you are quite rig h t Ah*. AIoss. Tha t is all I have. Air. Collier. Air. Chairman. The Chairman. Air. Collier. 32 FOOD ADDITIVES Mr. C ollier. T o pursue t ha t a lit tle fu rther , let us take a hypoth eti­ cal case of a produ ct now being wrapped in, say, a chemically coated paper. Let us say righ t now, the re is no problem. Let us say tha t a year from now, however, the prod uct fell u nder suspicion, because of something in the coatin g of the paper . Und er tha t law, if I inte rpre t it correctly, the depart ment would have no aut hority or jurisdi ction at tha t point. Mr. L arrick. Not unless we have had some real, substantial evi­ dence to show tha t it is not recognized by appro priate ly qualified experts as safe. Mr. Collier. But such auth ority is not provided in this legislation? Mr. L arrick. Last year, one of the biggest food companies in this countr y came to us a nd said th at t hey were pla nning to make a dry prod uct t ha t would make a ro ot beer. It would be a d ry powder anti you would pu t it in a glass of water and you would have root beer. This firm is a prude nt firm. I am not going to identify it. They took this materi al to the ir laboratories and they ran tests on it and they pr oduced tum ors, they th ought, in some of the la borator y analyses. They broug ht this evidence to us. We were not content to act on t ha t because the tests h ad not been made in our labora tories and they were not long enough to convince us, an d we wanted two tests, anyway. We start ed out wi th a 2 ^- ye ar study of the princip al ingredi ent of root beer and when we got about halfway t hrough this test o ur scien­ tists saw tha t on fur the r test ing th is ma terial m ight be shown to cause cancer, so I called in the princ ipal representatives of the bottli ng indus try of this country and we laid before them all of the facts. It was n ot a final jud gment th at this material was poisonous, but it was so highly suspicious th at we thou ght we should share tha t with the industry. This indus try decided tha t they would n ot use s afrole any more, safrole being t he co nstituent of root beer in question, and it h as been used from time immemorial. They pruden tly found substitutes for it and took it o ut of the root beer an d toda y there is none of i t in root beer. We have made a survey all over this country and it is out. We were able to do t his withou t any public clamor and they got it out before we concluded ou r test and we accomplished o ur objective with out any legal actions. When we can do tha t, we pre fer to handle it t hat way. Th at is the way I would h andle these very speculative things tha t are involved in th is m atte r th at we are discussing. Mr. D ingell. Mr. Chairman, I would like to be recognized for a few questions. The Chairman. Mr. Dingell. Mr. D ingell. Mr. Larr ick, I am goin g to ask the clerk to hand you a copy of the testimony of the previous witness, and I would like you to—in fac t, I will hand you my copy of th is—look at the specific lan­ guage th at I outlined and I will read it here for the record. I t is about t he fo urth line down. It s ays : I f th e sub sta nc es ma kin g up such ad di tiv e we re siiu ilft rly use d be for e Ja n ­ uar y 1, 1958. FOOD ADDITIVES 33 Tha t is a substitute as I read the bill for the words which a ppear just above, If such use was made of such add itiv e before Ja nu ar y 1, 1958. Wh at is the difference between those two readings and what is sought to be done ? Mr. L arrick. I have not seen this language before, Mr. Dingell. I am going to ask Mr. Harvey to answer th at. Mr. H arvey. 1 would t hink, Mr. Dingell, that the substances tha t make up such a dditive may have been used before, but the additiv e itself, the substance you are talk ing about tha t would go into the food, may not have been used prior to th at time. In other words, a food a dditive may be made up of a number of di f­ ferent substances. It may have had wide usage, but not in tha t com­ bination and not in t ha t arrange ment. Mr. L arrick. We want to deal with the art icle as it was used in the food, not some different usage. Mr. Dingell. Now we ar e ge tting down to the real purpose of this suggested amendment. Wha t they seek, then, is a combination ex­ emption for combination additives as opposed t o single constituents elements or single additives? Mr. L arrick. I would think tha t is right. Mr. D ingell. In other words, under this bill as I read it, they would get a blanket exemption. If one substance was jus t a p art of a whole complex additive, they would get a blanket exemption to cover the whole spectru m t hat mi ght be involved in tha t one pa rticu ­ lar additive. Mr. L arrick. Yes, I think this would perm it the use of different combinations of additives tha t had been previously used. Mr. Dingell. D o you read any other differences in this part icul ar dr af t tha t is submitt ed to us t his morning on this poin t from the bill tha t we are considering? Mr. L arrick. I think we would have to study this to answer th at question. Mr. Dingell. Would you like to have ti me to submit for the rec­ ord of the committee, y our views on this par ticu lar piece of legisla­ tion ? Mr. L arrick. I hope there will be no controversy about this bill, because it is tremendously impo rtan t to get it throu gh by March 6 and if there is something wrong with it and it goes through, it will give relief to the great bulk of the indus try and protect the public, and if there is something tha t we find is wrong with it, we will come back up here. Mr. Dingell. Let me go back a li ttle bit. I t is my unders tanding of the law tha t the duty tha t the law imposes up on an agency like yours, parti cular ly under the food additives law, is to act only on sound and competent evidence in cases of these sorts, parti cula rly dealing with the situation s where a substance m ight be regarded as being slight ly suspicious. The point I am leading to is just this. As a mat ter of law, you could not knock out a substance as an additive, eithe r a color ad ditive or a food a dditive, if you have a mere suspicion. Is tha t not righ t? Mr. L arrick. No. Eve ryth ing we do is reviewable in the courts 34 FOOD ADD ITIV ES and we have to have subst antial evidence before we act or the courts will knock us down. Mr. D ingell. And if you fail to have tha t su bstantial evidence the courts will overrule your a ctio n; is that not correct ? Mr. L arrick. As you know very well, tha t is true. Mr. D ingell. Than k you very much. The Chairman. There is jus t one fu rth er question I wanted to ask you, Mr. Larrick. You mentioned your auth ority. Would you subm it for the record at this point two or three citation s of the Supreme C ourt, because I do not want to be i n the position of dealing with what appears to be an unknown quant ity here, affected by an unknown authority . Mr. L arrick. I am going to ask Mr. "Goodrich to help me on tha t one. The Chairman. Mr. Goodrich, I am sure, will be gl ad to assist in doing just th at f or you. As I underst and, there is no difference between you and what Mr. Boyd has presented fo r his indus try, except Mr. Boyd and his indu stry are concerned aliout what would happen to something tha t has been sanctioned all these years, and suddenly i t comes up and some additive autho rity knocks it out the window all at one time. Mr. L arrick. Tha t is right. The Chairman. I thin k th at is a proper question t o raise. You think you have autho rity to deal with that. Now if we do not get this bill th rough by March 5, which obviously we will not be able to do because it takes a lit tle while fo r these thing s to make thei r way throu gh the Congress, the fact tha t there will lie a few days delay in enactment of this bill would not in any way cause your depar tment to move on any of these pending matters, would it? Mr. L arrick. I will have to enforce the law as it is w ritten, but if the legislation is m oving forw ard in due course, I would not be dis­ posed to speed up the action too fast. The Chairman. And as you mentioned awhile ago, an d as is yo ur duty, you would feel tha t you should lie reasonable about it? Mr. L arrick. Th at is righ t, but if it did not pass at all, I would have to move. The Chairman. Yes, I know tha t, but if it is moving it is a dif ­ ferent proposition. Mr. Boyd, did you have any fur the r comment, o r Mr. Muldoon? Mr. B oyd. May I just respectful ly say to the committee and to its capable chairman, many th anks for the opportu nity to a ppea r before you all, and if I just might mention to Mr. Dingell, as f ar as seeking any exemptions, sir, I do want t o disabuse him tha t we are requ esting an exemption. All we wa nt to do, as Mr. Larrick has always made perfect ly clear, is to confer upon the Secretary and upon Commis­ sioner Lar rick the auth ority when they have made certain requisite findings under the law, sir, tha t extensions mi ght be grante d. In other words, we are not suggesting that the law be open-ended and exemptions be c onferred. There would be no change as far as exemption status under our proposed amendment to IT.R. 3980. Than k you, sir. The Chairman. Thank you very much. Mr. Boyd. FOOD ADD ITIV ES 35 Mr. D ingell. Air. Chairman, I would ju st like to make one rem ark here for the benefit of Mr. Boyd. I have the distin ct impression, Air. Boyd, tha t in view of the com­ ments that you have heard from the expert s on t his subject, th at if you are not s tart ing a t shadows, you ar e seeking to shoot a very large hole or a series of very large holes into the law as it deals now w ith food additives. Air. Boyd. May I say to the able Represen tatives, tha t on Ja nu ary 31 in the Fed eral Register th ere was pub lished a generally recognized as safe list and there was a specific substance which happens to be a byproduc t in the indus try which was removed from the generally recognized as safe list. It happens tha t this par ticu lar substance is safe and it is my unders tandin g tha t an extension is being gr ante d, but that, of course, is prio r to Alarch 6, 1961, so my concern, sir, was suppose this very same t hing should happen aft er Alarch 6, 1961 in the ligh t of the language of II.R. 3908, withou t the amendment, and all we were hoping to do fo r the benefit of the people and the De par t­ ment of H ealth, Education, an d Welfar e, was to c arry out tha t second pa rt of the stateme nt referr ed to in the lett er of transm ittal, sir. It has happened once, sir, it could happen again. Air. D ingell. Y ou hear d the comment of Commissioner Larr ick on this point. Does tha t not appea r to satisfy any objection you m ight have to the bill as draft ed ? Air. Boyd. If I could be assured Commissioner L arrick would be here at all times, I would not have any worry. Mr. L arrick. I hope I will be. Air. Boyd. Than k you, sir. Air. Dingell. 1 thin k you have established a very clear legislative histor y this morning tha t it would be more inadequate protection. The Chairman. Than k you very much. Air. B oyd. Than k you, sir. The Chairman. I am going to have you gentlemen back in the morning at 10 o’clock, and we are going to hear you, but at 10:30 we are going to conclude the hear ing on this subject because we have other legislation tha t has been scheduled for tomorrow and we will take tha t up beginning at 10:30. The committee is adjourned until 10 o’clock tomorrow. (Whereupon, at 12:30 p.m., the hearin g was adjourned, to recon­ vene at 10 a.m., Wednesday, Alarch 1,1961.) FOOD ADDITIVES—EXTENSION OF TRANSITIONAL PROVISIONS WED NES DAY , MAR CH 1, 1961 H ouse of R epresentatives, Committee on I nterstate and F oreign Commerce. D.C . The committee met at 10 a.m., pursuan t to recess, in room 1334, New House Office Bifilding, Hon. Oren Ha rris (chairman of the committee) presiding. The C hairman. The committee will come to order. At the outset I would like to state that I am in receipt of a letter from Mr. George P. Larric k, Commissioner of Food and Drugs, re­ sponding to a request of yesterday with respect to his autho rity in dealing with a substance which heretofore was considered to be safe, or which is not now a food additive. In view o f the questions and discussion we had yeste rday, I feel tha t it would be advisable to read this letter in order tha t everyone may have the benefit of it. Since Commissioner Larr ick is present, it migh t be well to ask him to present this le tter. Mr. L arrick. I would be delighted, sir. STATEMENT 0E GEORGE P. LARRICK . COMMISSIONER, FOOD AND DRUG ADMIN ISTRAT ION Mr. L arrick. May I say, sir, I have delivered 50 copies to the clerk of the committee so that he can distribut e them to the people who are interested. Should I proceed? The Chairman. Yes; you may. Mr. L arrick. This letter is da ted Feb ruar y 28, 1961, addressed to the Honorable Oren Har ris, chairman of the Committee on Inte rstat e and Foreign Commerce, House of Representatives, Washington, D.C. Dear Mr. Chairman : Th is is in respon se to your requ est, at the hear ing on H.R. 3980, a bill to amend the tra nsi tio na l provisi ons of the Food Additives Amendme nt of 1958, th at we supply the commi ttee a sta tem ent as to the de­ pa rtm en t’s discr etion in deali ng wit h a subs tanc e which is not now a food add itive , unde r th at ame ndmen t, but which may sometim e in the f utu re meet the sta tu to ry definition. Fir st, it should be made plain th at the sta tu s of a subs tanc e gener ally recog­ nized as safe by qualified scie ntist s, or of a subst ance for which the re is a pri or sanc tion, canno t change wit hou t some new scientific evidence. A p rior s anctio n cann ot be with dra wn unles s the re is a fac tua l basis for wit hdr aw al. We have comm itted ourselves in our regu latio ns, excep t in cases of immin ent haz ard to hea lth, not to with dra w such a sanct ion wit hou t firs t provi ding a sta tem ent of the reas ons for our action. Whe re the wit hdr aw al of the sanc tion involves a singl e pa rty or a limite d numb er of par ties , we give our reas ons f or with draw al 37 38 FOOD ADD ITIV ES d ir ec tl y to th os e in te re st ed in it . W he re th is ca nn ot be do ne, th e no tic e is pu b­ li sh ed in th e F ed er al R eg is te r ex p la in in g wh y w it hdra w al is ne ce ss ar y. A su bs ta nc e ge ne ra ll y rec ogn ize d, a s sa fe by qu ali fie d ex p e rt s is no t su b je ct to th e foo d ad d it iv e s am en dm en t so lon g as th is ge ne ra l re co gn iti on of s af et y ex is ts. B ef or e th e s ta tu s of an y su ch su bs ta nce ca n l>e ch an ge d, th e re m us t be new sc ie nt ifi c d a ta w hi ch des tr oys th is u n iv er sa ll y he ld be lie f a s to it s sa fe ty . N or ­ m al ly , th is wo ul d re q u ir e th e co m pl eti on of sc ien tif ic st ud ie s an d th e pu bl ic at io n of th e re su lt s to dem ons tr at e to th e sc ie nt ifi c co m m un ity th a t it s lon g-h eld be­ li ef s a re no l on ge r w ar ra n te d . Se co nd, ev en a ft e r a p ri o r sa nct io n h a s be en w it hdra w n, or th e s ta tu s of a su bs ta nc e ge ne ra ll y re co gn iz ed a s sa fe h a s be en ad eq ua te ly dra w n in to qu es tio n, th e D e p ar tm en t st il l h a s th e bu rd en of pr oc ee di ng w ith en fo rc em en t ac tio n, if it w is he s to re q u ir e th e re m ov al o f th e su bs ta nc e fr om th e in te rs ta te m ar ke t. T hi s m ea ns we m ust be pr ep ar ed to pr ov e by a pr ep on de ra nc e of th e ev ide nc e in a ci vi l ca se , or be yo nd a re as on ab le do ub t in a cr im in al ca se, th a t th e su b­ st an ce m ee ts th e de fin iti on of a foo d ad di ti ve , as it a p p e a rs in se ct io n 20 1( s) of th e F ed er al Fo od, D ru g, an d Co sm et ic Ac t, an d th a t th e su bs ta nc e is no t w it h in t h e gr an d fa th e r- c la u se ex em pt io ns in th a t de fin iti on . T he se fe a tu re s of th e law , as a p ra c ti c a l m at te r, m ak e it ex tr em el y un lik el y th a t th e s ta tu s of an ex em pt su bs ta nc e m ig ht be ch an ge d ov er ni gh t. W e con ­ si de r it o u r re sp on si bi li ty to co m m un ic at e an y new fa c ts ab o u t an ex em pt su b­ st an ce to th e sc ie nt ifi c co m m un ity an d to pe rs on s kn ow n to be d ir ec tl y in te re st ed in it. T hi s wo uld giv e ad va nc e no tic e of th e pe nd in g ch an ge an d a n o pp ort unit y e it h e r to s t a r t th e p re p ar at io n of a foo d ad dit iv e pet it io n to es ta bli sh sa fe ty or to su pp ly co nt ro ver ti ng ev id en ce w ith re sp ec t to t he new sc ie nt ifi c de ve lo pm en ts. W he n th e ne w sc ie nc e fin all y re ac he s th e po in t th a t th e su bs ta nc e ca n no lo ng er be ge ne ra ly re co gn iz ed as sa fe , or es ta bli sh es th a t th e p ri o r sa nc tio n w as g ra n te d un de r a m is ta ke as to th e su pp os ed sa fe ty of th e ar ti cl e, th e D ep ar t­ m en t wo ul d ha ve to cl as si fy it a s a focal ad di ti ve . It wo ul d th en be su bj ec t to se iz ur e un de r th e foo d ad d it iv es am en dm en t, unt il a re gu la ti on w as pr om ul ga te d p e rm it ti n g i ts sa fe u se. I t is he re th a t th e dis cr et io n m en tio ne d [i n my te st im on y yes te rd ay co me s] in to pl ay . T he D ep ar tm en t is no t bo un d to pro ce ed im m ed ia te ly ag ai n st ev er y a d u lt e ra te d ar ti cl e. T he Su pr em e C ou rt, in U ni te d S ta te s v. S u ll iv a n (332 U.S. 68 9) , h a s m ad e it c le a r th a t th e d e p a rt m e n t ha s be en giv en br oa d di sc re tio n, “ br oa d en ou gh un do ub te dl y to en ab le (t h e C om m iss io ne r) to per fo rm his d ut ie s fa ir ly w it h o u t w as ti ng hi s ef fo rt s on w h a t m ay be no m or e th a n te ch ni ca l in ­ fr a c ti o n s of th e la w .” An d th e C our t sa id th a t th e sco pe of th e la w sh ou ld no t be n ar ro w ed by “e nv is io ni ng ex tr em e jio ss ib le ap pl ic at io ns of it s pr ov is io ns .” M or e re ce nt ly th e C ou rt, is an op in io n by C hi ef Ju st ic e W ar re n in R a th b u rn v. U ni te d S ta te s (35 5 U.S. 107, 10!)), h as s a id : “E ve ry st a tu te m us t be in te rp re te d in th e li gh t of re as on an d com mo n u n d e rs ta n d in g to re ac h th e re su lt s in te nd ed by t h e le g is la tu re .” A pp ly in g th is ru le of re as on , an d ex er ci si ng th e di sc re tio n re fe rr e d to by th e Su pr em e C ou rt, th e D ep ar tm en t wo ul d be ab le to cop e w ith th e si tu a ti o n in w hi ch a lon g- us ed su bs ta nc e, e it h e r on th e g en er al ly rec og niz ed a s sa fe li st or th o su b­ je c t of a p ri or sa nc tio n, is th ro w n in to qu es ti on un de r th e foo d ad dit iv es am en d­ m en t. If th e qu es ti on ar ose sim pl y be ca us e it w as le ar ne d th a t som e su bs ta nc e of un kn ow n id en ti ty m ig ra te d fr om pa per bo ar d, th e d e p ar tm en t wo ul d no t be co m pe lle d to im m ed ia te ly in it ia te a se iz ur e ca m pa ig n a g a in st al l pap er boa rd im ck ag ed fo od. B ut i f it w as le ar ne d th a t th e m ig ra n t w as on e ab ou t w hi ch th er e w as a se ri ou s qu es tio n of sa fe ty , or on e of un kn ow n to xi ci ty , th e D ep ar tm en t sh ou ld ha ve th e a u th o ri ty to pr oc ee d in th e pu bl ic in te re st . T his ki nd of ac ti on is p er m it te d by th e p er m an en t p ro vi si on s of th e a ct. T hus a d eq u at e fle xi bi lit y in a d m in is tr a ti o n al re ad y ex is ts . W e do no t be lie ve th a t th e la w sh ou ld pr ov id e fo r e xte nsi ons fo r al l su bs ta nc es th a t m ay a t an y tim e h e re a ft e r be fo un d to be foo d ad di ti ves . Th e pu rp os e of th e foo d ad di ti ve s am en dm en t is to pr ov id e, a ft e r a re as ona ble tr a n si ti o n pe ri od , th a t ad di ti ve s sh al l m ee t al l re q u ir em en ts w it h o u t ex ce pt io ns . Mo reo ver , th e po ss ib il it y th a t a su bs ta nc e th ou gh t no t to be w it hin th e sc op e of th e foo d ad d it iv es am en dm en t m ig ht a t som e fu tu re ti m e tu rn ou t to be w it hin it s sco pe, is in her en t in ev er y pr ov is io n of re g u la to ry law , in cl ud in g o th e r pr ov is io ns of th e Fo od. D ru g, an d Co sm et ic Ac t, an d it wo ul d m an if es tl y be un so un d to c re a te po ss ib le loo phole s re ­ la ti n g to a ll th es e si tu at io ns . We re ce nt ly re vi ew ed th is w ho le m a tt e r w ith re p re se n ta ti v es of th e ch em ic al in d u st ry an d as ke d fo r an y co nc re te ex am pl es th a t m ig ht ju s ti fy a per m an en t pr ov is io n in th e law a uth ori zi ng th e D e p ar tm en t to ex te nd it s ef fe cti ve ne ss fo r FOOD ADD ITIV ES 39 2 ye ar s, or an y ot h er pe rio d, w hi le ne w sc ie nt ifi c pr ob le m s a ri si n g w ith re sp ec t to an old ad di ti ve w er e ex pl or ed . No su ch ex am pl es co ul d be giv en to us , an d ab se nt su ch an ex am pl e we ca nn ot re co m m en d m od ifi ca tio n of tli e hi ll to a u ­ th or iz e su ch a n ex te ns io n. I t m aj ' he th a t som e su bs ta nc es w hi ch w e ha ve li st ed as g en er al ly r ec og ni ze d as sa fe , an d som e fo r wh ich we ha ve g ra n te d p ri o r sa nc ti on s, w ill ch an ge in s ta tu s w ith th e em er ge nc e of ne w sc ie nt ifi c kn ow led ge . I f th ey do, th e new kn ow le dg e wo uld ha ve to es ta bl is h a se ri ou s qu es ti on of do ub t of sa fe ty . In an y su ch ca se , w e be lie ve th e be st co ur se wo uld be to rem ov e th e su bst an ce fr om th e fo od su p ­ pl y w hi le th e is su e of do ub t w as be ing re m ov ed ra th e r th a n to a pp ro ve a b la n k et ex te ns io n. If th e do ub t w er e not a se ri ou s on e, th e re wo uld be no ne ed fo r im m ed ia te a cti on . A dd iti on al ly , as de ve lo pe d by s om e of th e m em be rs of th e co m m itt ee d u ri n g t h e he ar in gs , th e pr op os ed de le ti on fr om su bs ec tio n (c ) of se ct io n G of th e foo d ad dit iv es am en dm en t of th e w or ds “i f su ch us e w as m ad e of s uc h ad d it iv e b ef or e J a n u a ry 1 ,1 95 8” a n d s u b st it u ti o n th e re fo r of t h e w or ds “ if t h e su bs ta nc es m ak in g up su ch ad dit iv e w er e si m il ar ly us ed be fo re J a n u a r y 1, 1958” wo uld w ea ke n th e p re se n t co nc ep t of th e focal ad d it iv es am en dm en t an d of th e ad di ti onal ex te ns io n a u th o ri ty co nt em pl at ed in 1I.K. 3980. II .I t. 398 0 is in te nded to a llo w u s to g ra n t fu rt h e r ex te ns io ns on ly fo r th e ex ac t us es th a t w er e m ad e of a foo d ad d it iv e be fo re Ja n u a ry 1, 1958. T he am en dm en t pr op os ed by th e A m er ic an P a p e r & P u lp A ss oc ia tio n w ou ld g re a tl y ex pa nd th is a u th o ri ty an d wo uld au th o ri z e ou r d e p ar tm en t to g ra n t ex te ns io ns fo r var io us us es of a gi ve n ch em ic al so lo ng a s it h a d be en us ed in a so m ew ha t re la te d m an n er be fo re J a n u a ry 1, 1958. As I m en tio ne d in m y te st im on y, th is re quir em en t th a t a su bs ta nc e to be g ra n te d fu rt h e r ex te ns io n m ust ha ve be en us ed p ri o r to J a n u a r y 1, 1958, gi ve s ad de d su pp or t to th e de ci si on s of our sc ie n ti st s th a t f u r th e r li m it ed ex te ns io n w ill be w it h o u t un du e ri sk to th e pu bl ic h e a lt h ; th is ad de d su p p o rt wo uld no t e x is t fo r ne w us es of th e sa m e ch em ic al s w hi ch had no t be en su bj ec te d to th e te st of tim e. Si nc er el y yo ur s, G eorge P. L arr ick , Comm ission er of Food and Drugs. T he C ha ir m an . T h an k yo u ve ry mu ch , M r. L ar ri ck . W e will now he ar fro m M r. K en ne th M ul fo rd , ch ai rm an , Fo od A dd iti ve s Co m mi tte e, M an u fa ct u ri n g C he m is ts ’ A sso cia tio n. STATEMENT OF KEN NET H E. MTJLFORD, CHAIRMAN , FOOD ADDI­ TIVES COMMITTEE. MANUFACTUR ING CHEMIST S’ ASSOCIATION. INC. M r. M ulford . M r. C ha ir m an an d me mb ers of th e co mm itte e, w ith y o u r pe rm is si on 1 su gg es t, in o rd er to co ns er ve tim e, th at , as I di d ye st er da y, th e p re p ar e d st at em en t w hi ch ha s bee n su bm itt ed to yo u be in co rp or at ed in to t he r ec or d, to ge th er w ith t he a cc om pa ny in g le tt er da te d F eb ru ar y 21, 1961, fr om G en er al H ul l, pr es id en t of t he as so ci a­ tio n to th e c ha ir m an o f th is com mi tte e. T he C ha ir m an . Le t it lie i ns er te d in th e r ec or d. (T he do cu me nt re fe rr ed to is a s f ol lo w s:) S t a te m e n t of K e n n e t h E. M ulf ord on B e h a l f of the M a n u fa c t u r in g C h e m is t s ’ A ss o c ia ti o n , I n c . Mr . C ha ir m an a n d m em be rs of th e co m m itt ee , my na m e is K en ne th E. Mu l­ fo rd . I am ch ai rm an of th e Fo od A dd iti ve C om m itt ee of th e M an u fa ct u ri n g C he m is ts ' A ss oc ia tio n. Th e M an u fa ct u ri n g C he m is ts ’ A ss oc ia tio n is a tr a d e as so ci at io n com po sed of 190 co rp or at e m em be rs w hi ch a re en ga ge d in th e m a n u fa c tu re of ch em ic als . Am on g th e p ro du ct s so ld by ch em ic al pro du ce rs a re p ro d u ct s wh ich be co me fo od co m po ne nt s e it h e r in te n ti o n al ly to per fo rm so me fu nc ti on in th e foo d, o r un in te nt io na ll y, as . fo r ex am pl e, m ig ra n ts fr om fo od w ra pp er s. B ot h th e in te nt io nal an d u n in te n ti o n al foo d co m po ne nt s a re su b je ct to th e co ntr ol s of th e Fo od A dd iti ve s A m en dm en t of 1958 un le ss th ey a re us ed fo r co lo rin g foo d, 40 FOOD ADD ITIV ES in which case they are subject to the Color Additive Amendments of 1960. Under d ate of Februa ry 21, 1961, Gen. John E. Hull, president of the Manu­ facturi ng Chemists’ Association, wrote a lett er to the honorable chairman of your committee endorsing H.R. 3980 with one small amendment. For the benefit of those committee members wTho may not have had an opportunity to read this letter, I should like to read i t into the record. (See le tter below.) As I believe th e lette r to be s elf-explanatory as to the position of the Manu­ facturing Chemists’ Association with respect to the need for early passage of this legislation, this will conclude my statement, except that, of course, I shall be glad to answer any questions which you gentlemen of the committee may have. Thank you very much, Mr. Chairman, for the opportunity to present these views on b ehalf of the Manufacturi ng Chemists’ Association. M anufa cturi ng C he m is ts ’ A ssociat ion, I nc., 'Washington, D.C., February 21, 1061. Hon. Oren H arris , Chairman, Committee on Inter state and Foreign Commerce, House of Representatives, Washington, D.C. D ear Mr. H ar ri s : Our association has carefully studied H.R. 3980, a bill introduced by you to amend the trans ition al provisions of the Food Additives Amendment of 1958 and the Nematocide, Pla nt Regulator, Defoliant, and Desiccant Amendment of 1959. Your bill appears to be the same as tha t suggested originally by former Secretary Flemming in a communication dated Janu ary 13, 1961. On Thursday, Febr uary 16, 1961. Secretary Ribicoff by letter to you, endorsed Secretary Flemming’s action and stated that he was in full accord with this legislative proposal and tha t he hoped your committee would take favorable action on the proposal as soon as jiossibie. Our association believes t hat it would be b etter to have legislation giving the Secretary of Health, Education, and Welfare broad admini strative discretion to gran t extensions under the two amendments mentioned above aft er March 6, 1961, if he found tha t there were reasonable grounds for not having com­ plied with the prerequisi tes of the amendments. However, due to the very short period of time before the March 6 deadline, we would li ke to call to your attenti on only one minor point. Both in section 2 and in section 3, the Secretary of Health, Education, and Welfare may ex­ tend the effective d ates of the two amend ments where he has a lready extended the effective date to March 6, 1961. This language would mean tha t in cases where a manu factu rer has in good fa ith filed with FDA a request for an exten­ sion and FDA has not been able to act on such a request, then such a manu­ factu rer would be ineligible for an extension aft er March 6, 1961. We under­ stand tha t the Food and Drug Administr ation is aware of this minor defect in the bill and will shortly suggest language to your committee to correct it. We would like to endorse such FDA action in advance so th at manufa cturers who have filed requests for extensions witho ut FDA having acted on such requests, would be eligible for extension af ter March 6.1961. As you are aware, the footl additives amendment has resulte d in a number of problems fo r the Food and Drug Adminis tration and for affected industries. Many manuf acturer s have diligently sought to learn whether thei r products were food additi ves as defined by the act. In many cases, it has only been with furth er refinement of analytica l techniques tha t manufa cturers were able to conclude th at they did hav e food addi tives subject to t he act. Also, it is well to point out th at many required animal tests cover a long period of time. We respectfully urge t hat your committee as soon as possible repor t favor ably H.R. 3980 with the one amendment refer red to above and which we understand will be suggested by the Food and Drug Administration. In the event tha t you consider it necessary to hold hearings on H.R. 3980, our association would greatly appreciate receiving notice of this so th at we may app ear and testi fy in support of the bill. Sincerely, J. E. H ull . Mr. Mul/ford. I will then direct a few remarks to the committee. Firs t, briefly, th e position of ou r association is that while we would prefe r to have the Secretary have grea ter discretion ary power in FOOD ADD ITIV ES 41 gra ntin g extensions, we feel t ha t Mar ch G is not only jus t around the corner, but we are practic ally stumbling over it, and, the refore, under the circumstances we feel that this bill, H.R. 3980, should be prom ptly passed, amended as suggested yester day by Commissoner La rric k in his testimony. Now I would like to comment as to why we put this pref ator y statement in, that we feel th at the Se cretary should have more discre­ tionary power. I would like to emphasize t ha t we do not feel this is desirable in any case where there is a public healt h problem involved or any undue risk to public health. We only fel t tha t the Commis­ sioner should have this autho rity in the event t ha t some tech nicality comes up under the present law th at would ap pear on its face to p re­ vent him from gra ntin g an extension when there had been no question about the safety of the product, but the person or ingredient just happened to be pa rt under some unfo rtun ate circumstances. In discussing this with representativ es of the Food and Drug Ad ­ ministration, the conclusion was reached t hat perhaps here t his is not necessarily something that, should be take n up in this extension bill. As Commissioner L arri ck has pointed out, it probably is a question with respect to the bill as a whole. In other words, this type of th ing might occur in the year 2000. So that we feel tha t, ra ther than try and straig hten such a matt er out at this time, the presen t bill should be passed with the amendment t hat Commissioner Larrick has suggested. The o ther poi nt I would like to comment on is t he suggestion made yesterday that an overall time limit be placed on th is bill. Back in 1958, when we had no idea of t he terrific magnitud e o f this problem, the Manuf acturin g Chemists’ Association position at that time, and the testimony, was that it would take at le ast 5 veal’s to get his mat ­ ter straighten ed out. I just won’t take the time to go into the tre ­ mendous number of problems involved in compliance with this act, and the wonderful job that I think both indu stry and the Fcxxl a nd Drug A dministr ation has done in the time that we have had so far. T would like to say, however, tha t a great deal more time is going to be needed. And, if i t is the judgmen t of your committee t hat an overall time limit should be placed on this extension bill, then it should l ie at least 5 years and certa inly no less than 3. I think tha t concludes my statement, Mr. Chairman. The Chairman. Any questions by members of the committee? (No response.) The Chairman. Than k you very much. We are very glad t o have your testimony, Mr. Mulford. Mr. Mulford. Than k you. The Chairman. Mr. II . E dwar d Dunkelbe rger, J r., of the Nati onal Canners Association. STATEMENT OF H. EDWARD DUNKELB ERGER, JR. . COUNSEL, TH E NATIONAL CANNERS ASSOCIATION Mr. D unkelberger. My name is H. Ed ward Dunkelberger, J r., and I am appear ing on be half of the National Canners Association. We would like to express our apprecia tion to th e c hairman and the com­ mittee for this oppor tunity to pres ent this s tatement t o the committee. The National Cannel’s Association, on beh alf of its members, urges 42 FOOD ADD ITIV ES that, this committee give immediate and favorable consideration to H.R. 3980. Because Sec retary Flemming in his lette r of transm ittal to Speaker Raybur n and Secretary Ribicoff in his statement before this committee fully outlined the need for this legislation, we will coniine thi s statement to noting our agreement with that letter and the accompanying explana tion and the Secretary's statement yes­ terday. We would like to suggest, however, a minor amendment to the bill that is entirely consistent with the avowed purpose of the bill and which, in our view, is necessary if t hat purpose is to be satisfac­ torily car ried out. Unde r the bill as prese ntly draf ted, an d even w ith the amendment tha t Commissioner Larr ick proposed yesterday, the Food and Drug Admin istrati on will be obliged to give individual consideration to each of the 3,000 extensions which have already been gra nted under the present act, for in no other way can it be d etermined whether fur the r extensions would meet the specific requirements of the bill. Only if these requirements are met would a fur the r extension tie authorized. It seems clear beyond question that there will not be time afte r the enact ment o f th is bill and before March 6—indeed, if it comes in that order at all—for all interested parties to present information establishing that the additio nal requirements of the bill have l>een satisfied with respect to substances covered by outsta nding exemp­ tions. Even if such informa tion were in the hands of the Depa rt­ ment, it is unrealistic to suppose that Department personnel will have time pr ior to March 6 to examine and pass upon th is informatio n for all 3,000 extensions. In a ddition to passing upon extensions and send­ ing extensions, the Departmen t staff will, of course, be actively en­ gaged in processing petitions for final regu lations listin g food a ddi­ tives for use. If these assumptions are correct, then it follows tha t on March 6, or upon whatever date even aft er the act is enacted, the present ex­ tensions will expire and thousands o f food products will be in techni­ cal violation of the act until such time as the Departm ent has acted upon each of the extensions p ending or previously granted. We feel it is necessary, therefo re, that H.R. 3980 be amended to provide an additional 6-month period or whatever period the FDA feels is necessary, duri ng which all present extensions to consider and act on furt her extensions for each of the food additives f or which an e xtension is in effect or is pending, and at the same time to con­ tinue to process petitions f or regulation s. This 6-month or 7-month blanket extension could be written into the bill by str ikin g out the word “he” in line 5, page 2, a nd inserting the following language aft er the words “food additiv e,” in line 4 on page 2: such effective date shall be furth er extended with respect to such use of the addi­ tive to September 0. 1961, and the Secretary. And then it would continu e on. Tha t September date, of course, could be changed to whatever period is desired to be necessary. The same amendment, if it is tho ught to be necessary, could be a dded to section 3 of the bill. The C hairman. Mr. S pringe r. FOOD ADD ITIV ES 43 Mr. S pringer. Could I ask Commissioner La rrick a question? Do you have any objection to the s uggested amendment? Mr. L arrick. Mr. Sprin ger, I had anticip ated tha t the question would be asked and one of my able assistants has writte n out the ques- tion and answer. And if I may, 1 would like to read it. Qu est ion . W lia t ha pp en s on M ar ch 6, 1961, ev en th ou gh II .R . 3980 w er e en ­ ac te d? I t se em s th a t FD A wo ul d ha ve in su ffi cie nt ti m e to co ns id er th e m an y re qu es ts fo r ex te ns io ns th a t w ill be f or th co m in g. A ns we r. I f II .I t. 3980 is en ac te d, w e w ill ad vi se th e af fe cte d in d u st ri es th a t w e a re re ad y to co ns id er re que st s th ey w is h to m ak e fo r fu rt h e r ex te ns io ns of th e eff ec tiv e d a te of th e law . W e w ill al so ad vi se th em th a t fo r a re as onab le pe ri od of tim e to p e rm it ev al uat io n of th e ir re qu es ts th e ex is ti ng ex te ns io ns w ill no t l>e c an ce le d. I t wo uld a p p e a r to us th a t a co up le of m on th s w ou ld be a re as on ab le t im e w it h in w hi ch to han dle a d d it io n al re q u es ts fo r ex te ns io ns . Now, answering your question specifically, I do not think it is necessary. If the committee wants to write it in the bill, we would not object. The Chairman. You would not what ? Mr. L arrick. We would not object. We are go ing to do it anyway. Mr. S pringer. Tha t is all. The Chairman. Mr. Keith. Mr. K eith. I am not an att orney, but it would seem to me t hat th e action he contemplates would be outside the law, and tha t in order for him to do what he says he would do an yway we would necessarily have to make this amendment. The C hairman. I see no p artic ular reason to belab or th e p oint one way or the other because I think definitely they would have the auth ority if we passed the legislation. And if it is goi ng to be done anyway, it will be done whether this is entered or not. I see no reason to waste a great deal of time on it myself. Any fu rthe r questions? Mr. Moss. I have one question of Mr. Larri ck on this point. This would have the effect of giving extensions on all matters for 6 months? Mr. L arrick. No ; it would not have that effect. It would mean tha t i f someone in good fa ith----- Mr. Moss. No; I mean the proposed amendment. Mr. L arrick. Oh, thi s proposed amendment? Of course, yes, th at would be a blanket extension. Mr. Moss. That would be a blanket extension. Mr. L arrick. We do not think tha t is in the public interest. Mr. Moss. That is all. Mr. Dingf.ll. Mr. C hairman, could I ask the previous witness, not Mr. Larric k, just one brief question ? The C hairman. Mr. Dingell. Mr. Dingell. You said, your suggested amendment i s: su ch eff ec tiv e d a te sh al l be fu r th e r ex te nd ed w it h re sp ec t to su ch us e of th e a d d it iv e to Se pt em be r 6, 1961, an d th e S e cr et ar y — Now, have you had any experiences with the Food and Drug Ad ­ minist ration under the existi ng law which would, in yo ur mind, make necessary that we adopt such an amendment ? Mr. Dunkelberger. Well, our only concern. Mr. Dingell, was to see tha t—as we read the bill, we agreed with Mr. Keith, that tech­ nically there was no author ity for blank et extensions in the bill. Each 44 FOOD ADD ITIV ES extension h as to be considered separate ly as th e bill is now written. And there has been great emphasis made on this point, tha t each exten­ sion would be considered separately. And, therefore, when March 6 came and went there would not be time for all 3,000 to be con­ sidered tha t way. So we though t there should be a brief period authorized in the law author izing the FD A to gran t a brief time during which all of them can be considered, and then everyone would get off to the same st art aga in w ith no technical violations of the law. Mr. Dixgell. Tha t is a very good answer, but it does not come righ t to the point I was exploring, and tha t is th is : Have you had any experiences with the food a nd drug tha t would indicate to you tha t this amendment is necessary, any specific experiences ? Mr. D uxkelberger. No ; we have had no experience tha t the FDA would take advantag e—as a mat ter of fact, the Commission has al­ ready indicated they would not, and we have no experience they would t ake advantag e—or what we would say is a technical defect in the bill, to take unf air advantage of industry . We have no ex­ perience whatsoever that they would do that . Mr. D ixgell. I am not a believer in enacting unnecessary legisl a­ tion i f we can avoid it. We have enough to do without passing a lot of unnecessary law. And in view of your statement tha t you see no reason from your own experience why this is necessary, I wonder why we should bother even considering it ? Mr. Duxkelberger. Well, as t he Commissioner has assured us, he will gra nt this anyway whether it is enacted into the bill or not. It would seem th at the need f or the amendment, therefore, is some­ what diminish ed, bu t it is required technically within the wording of the bill tha t is now written. Mr. Dixgell. Tha nk you very much. The Chairman. In other words, if it is goin g to be done, you do not care whether it is in there or not ? Mr. Dux’kelberger. Tha t is right, sir. The Chairman. Than k you, very much. Mr. Michael F. Markel. STA TEM ENT OF M ICH AE L F. MA RKE T, FOOD, DRUG, AND COSMETICS SECTIO N, NE W YORK BA R ASSOCIA TION Mr. Markel. Mr. Chairman, I do not have a prepar ed statement. I do appea r here in behalf of wha t I recognize as an organized gro up of lawyers who are very much interested in this whole problem. And in d emonstra ting my authoriz ation to speak, and giving my qualifica­ tions, I would like to say t ha t the lawyers in the food, d rug a nd cos­ metics field are organized formally. We are a division in th e corpora ­ tion, banking, and business law section in the American Bar Asso­ ciation. I am a chairman of th at division, and I am a member of tlie council of tha t section. However, as the lawyers among you no doubt know, we cannot speak for the American Bar Association without having resolutions approved by the board of governors, so I cannot come in and say I am speaking for the American Bar Association. But the same gr oup of lawyers is also orga nized as a section in the New York State Bar Association, and we are authorized to act as a group and as a division. And I am past vice chairman of tha t FOOD ADD ITIV ES 45 division. I am a member of a n umber of the ir committees, and last Jan uar y at thei r annual meeting I was appoin ted chairman of the resolution committee, and we adopted a resolution, as the lawyers, and not as a bar group, sup portin g this bill. Upon adoption of the resolutio n a committee was app ointed to fol­ low through on this with the Food and Dru g Admi nistrati on and to assist th is committee, and I was appo inted chairman of th at com­ mittee. So I am here speaking in that capacity. As far as my personal interests and experience in this area are concerned, I am a member of Markel & Hill , a law firm here in Wash ­ ington, and we have a g reat deal of work i n this area. I have been concerned w ith this problem ever since before there was a food add i­ tive amendment. And at the risk of appea ring immodest, I want to say t hat in 1948 I wrote a paper, which was published, where I sug­ gested that it was time to consider legislation such as the food add i­ tive amendment, and advised the food indus try tha t they ough t to give serious heed to this. At tha t time I was a lone voice in the wil­ derness. I am merely mentioning tha t to show tha t I have been much concerned. Now then, to come down to this specific bill, our committee did meet with the Food and Drug Admi nistrati on, and we did discuss this bill. And Commissioner Larr ick yesterday did suggest revision of language which will take care of what our committee w anted to take care of: namely, tha t the language should be extended so as to include all matt ers now before the Food and Drug Adm inistr a­ tion. That is, extensions, pending petitions, and pe nding requests for a ruling. And that, is t he revision that Air. Larr ick has suggested, and it is our considered opinion, and I have discussed this with my committee, that a bill along tha t line should be p romptly passed. Durin g tha t discussion there also came up the problem tha t has been discussed at some length here. It was readily appar ent to us, and to me, tha t that has no place in this bill. We are mixing ap ples and pears here. This matte r was something th at may come under the other side, something tha t would requ ire a fundam ental amendment of the act. There will be cases such as that for this r eason : The single judicia l question re maining in this whole area is the question which will arise if some manu factu rer of a substance chooses to disagree with the Food a nd Drug Adm inistra tion as to w hether it is or is not generally recognized as safe. In the event of such a disagreement, the courts would have to decide. Now there may well be possibilities along tha t line, and that, is what the bar g roup and some of the food groups are concerned about. Fo r example, last week one in dustry group filed a list of, I guess, over 100-some substances where they did not ask for a ruling . They said, “We and the board tha t we have appoin ted say we have con­ cluded this is generally recognized as safe.” Now supposing tha t the Food and Dru g Admi nistra tion does not agree with them with respect to each item. I happen to know at least two people who do not. want to go to court. They want to say, “All righ t, let’s file a petitio n.” So there is this possibility. But there is no present prob ­ lem, and tha t should be sep arated and should be th e subject of con­ sideratio n when you have more time under a separate bill, because tha t requires a basic amendment to the present law and is not an ex- 46 FOOD ADD ITIVE S tension in any sense of the world ; it is a broadening of admi nistra ­ tive power. And I have discussed tliis now since yesterday with some of my committee members and I am sure—confident—tha t I speak for the majo rity of the food and drug lawyers in this instance who un der­ stand it, an d I would say I could convince the ma jority of those who disagree if I had a half hour with them to explain it to them, that tha t question should be eliminated completely from consideration of this bill and this bill should be passed as recommended by the Commissioner yesterday and should be done so promptly. Now, as to the time element, we have thou ght t ha t p erhaps 5 years would be a more realistic time, but in view of what Congressman Delaney said yesterday, if the time came and there were still demon­ strable problems, and in view of what the Commissioner said yester­ day, we have concluded, and our committee has concluded, 3 years will do. And we are perfectl y happ y to accept that. Now’ th ere is only one other point I wanted to make, an d tha t is I want to address myself to the comment tha t Mr. Delaney made yester ­ day in quoting Mr. Depew, Fr ank lin M. Depew, president of the Food Law’ Insti tute. I want to assure Mr. Delaney th rough this commit­ tee—and I spoke to Mr. Delaney yesterday afternoon about this —that Mr. Depew’ was fully in accord with what I have said. I know’ h im; I am a member of the advisory legal board of the Fo od Law’ Instit ute. It is a most highly responsible organizatio n, and I want to just make this clear. I do not know’w hat Mr. Depew said ; it came from a paper which he gave before our b ar association, and t he s tatement tha t Mr. Delaney read came fro m t hat p ape r evidently. But I want to assure this committee tha t the organized industry , regulated indust ry, has no intent ion of dilut ing a nyth ing here, and parti cula rly not th e Food Law Inst itute . And Mr. Depew, I want to say, is in accord with every thing th at I have said. So we recommend very stro ngly t ha t we promp tly pass this bill wit h t he amendments tha t Commissioner Lar- ric.k has suggested, and tha t when a nd if the need arises, and they, are prepa red to de monstrate the need for amending the basic act so as to take care of the o ther problem, th ere will be time enough to take tha t up when we have more time to discuss it. Tha nk you very much, Mr. Chairman . The C hairman. Thank you very much, Mr. Market. Any questions by members of the committee? Than k you, w’e appreciate havi ng your statement. This will conclude the hearing on 11.R. 3980. (The following mate rial was submitted fo r the record :) T h e F ood L aw I n s t it u t e , I n c ., New York , N.Y. , March 3, 1961. Re H .R . 3980, Fo od A dd iti ve s T ra n si ti o n a l P ro vi si on s A m en dm en t of 1961. H o n . O re n H a r r is , Chairman, Hous e Comm ittee on I nt er sta te and Foreign Commerce, House Office Build ing, Wash ington , D.C. D ear M r. H ar ris : T he Fo od L aw In s ti tu te w as an d re m ai n s a st an ch su p­ p o rt e r of th e Fo od A dd iti ve s A m en dm en t of th e F ed er al Fo od , D ru g, an d Co s­ m et ic Ac t, w ho se H ou se re p o rt a n d p as sa g e yo u su cc es sf ul ly di re ct ed as ch a ir m a n of th e H ou se In te rs ta te a n d F or ei gn Co mm erc e C om m itt ee in 1958. My pr ed ec es so r. Mr . C h ar le s W es le y D un n, a s lo ng as 10 y e a rs ag o ur ge d th a t th is ty pe of le gi sl at io n w as ne ed ed fo r th e pr ot ec ti on of th e pu bl ic h ea lt h. FOOD ADD ITIV ES 47 W e no w ur ge yo ur co m m it te e’s ap pro va l of th e bi ll H .R . 3980, th e Fo od A dd i­ ti ve s T ra n si ti o n a l A m en dm en t of 1961. T hi s am en dm en t af fo rd s th e nec es sa ry a d d it io n a l ti m e to co m pl et e in ve st ig at io ns of v ar io u s old su bst an ce s to d et er m in e th e ir sa fe ty fo r fo od use u n d e r ap pr ov ed co nd iti on s, an d su b je ct to s tr ic t a s s u r­ an ce s of c on su m er p ro te ct io n. W e al so ur ge yo ur ap p ro v al a n d re co m m en da ti on of tw o po ss ib le re vi si on s of th e b i l l : fir st , to en la rg e it s ap pl ic at io n so th a t re q u e st s fo r ru li ng s an d pe ti- ti o n s fo r re gu la ti on s no w pe nd in g be fo re tli e S ec re ta ry m ay qu al if y, a s w ell as m a tt e rs a lr ea dy su bj ec t to an ex te ns io n ; a nd , sec on d, to h av e an y tim e li m it at io n (i f on e is in se rt ed in th e bi ll ) c a rr y th e S e c re ta ry ’s dis cr et io n fo r g ra n ti n g e x ­ te ns io ns , a t le as t i n to th e m id dl e of 1964. P le as e ac ce pt th is le tt e r fo r th e re co rd in lie u of my pe rs onal a p p ea ra n ce a t th e re ce nt h ea ri ng s on th is b ill h el d by y our co m m itt ee . I a m, w it h co rd ia l r eg ar ds , R es pe ct fu lly yo ur s, F ra nk li n M. D ep ew , P re s id e n t. F ebrua ry 25, 1961. Com mi tt ee on I nte rst ate and F oreign Comm erce , House Office Building, Washington, D.C. D ear S i r s : Th e m em be rs of th e B ri dg ew at e r H om em ak er s Cl ub re sp ec tf ull y p ro te st d ra f t bil l II. R. 3980, re fe rr e d to by ti tl e “ Fo od A dd iti ve s T ra n si ti o n a l P ro vi si on s A m en dm en t of 1961 ”, to am en d th e tr a n si ti o n a l pr ov is io ns of th e a c t ap pr ov ed Se pt em be r 6, 1958. T hi s law , we a re c e rt a in , is no t in th e pu bl ic in te re s t an d sh ou ld be de ­ fe at ed , be ca us e it d e fe a ts th e pu rp os es of th e a c t ap pr ov ed Se pt em be r 6, 1958. by ci rc um ve nt in g it s tw o sa fe ty c la u se s: (1 ) “ to p ro h ib it th e us e in th e fo od of ad d it iv es wh ich ha ve no t be en ad eq uat el y te st e d to es ta b li sh sa fe ty .” (2 ) T he D el an ey ca nc er cl au se w hi ch “r ule s ou t a su b st an ce if it is fo un d to in ­ du ce ca nc er in m an or an im al , a ft e r te s ts w hi ch a re a p p ro p ri a te fo r th e e v a lu a ­ tio n of th e sa fe ty of fo od ad d it iv es .” I t al so giv es th e Fo od an d D ru g A dm in is tr at io n un li m it ed a u th o ri ty to ex te nd th e us e of th es e to xi c ch em ic al s, a t th e ir pl ea su re . O ur st u d y of th e ac ti on s of th e Fo od an d D ru g A dm in is tr at io n in th e pa st , giv e us li tt le co nfi de nc e th a t th is a u th o ri ty wi ll be us ed in th e pu bl ic in te re st ra th e r th a n in th e in te re st of th e fo od pr oc es so rs an d m a n u fa c tu re rs . W e ho pe yo u wi ll be in te re st e d in th e fo llo w in g se le ct ed bi bl io gr ap hy w hi ch w e p re se n t a s th e ba si s fo r o u r st at em en ts . 1. A gr ic ul tu re D ep a rt m e n t's w a rn in g on th e su bj ec t, in a co nf id en tia l re p o rt pr ep ar ed by R al ph T ri gg of th e P ro du ct io n an d M ar ke tin g D iv isi on fo r S ec re ta ry C h ar le s B ra nna n. T h is ap pe ar ed in th e W as hi ng to n P os t Ma y 3. 1949. 2. A le tt e r fr om D r. W il li am E. Sm ith to C on gr es sm an .Tames J. D el an ey of Ne w Y or k— C on gr es si on al Re co rd of th e 85 th Co ng re ss , 1s t ses sio n. 3. “T he Po iso ns in O ur Fo od ”—by W ill ia m Lo ngg ood . 4. Fo od an d D ru g A d m in is tr at io n R ep or ts . 5. T he Ne w Yo rk Ti m es . Si nc er ely , B ridge wate r H om em ak er s C lub , J o se ph in e P. S hi ve ly , Editor, Woman's Health News, Route 2, Quaker City, Ohio. N opco C he mi ca l Co., Newark, N.J., February 24, 1961. S u b je c t: H. R. 3980, Fo od A dd iti ve s T ra n si ti o n a l P ro vi si on s A m en dm en t of 1961. Ho n. O ren H arr is , Chairman, House Interst ate and Foreign Commerce Committee, House of Representatives, Washington, D.C. S i r : A s a ch em ica l m an u fa c tu re r, ou r co m pa ny is v it a ll y in te re st ed in an y ac ti on Co ng re ss m ay ta k e in co nn ec tio n w ith th e ab ov e- id en tif ie d bil l. As you a re w el l aw ar e, th is bil l, am on g o th e r th in gs , w ill em po w er th e S ec re ta ry of th e D e p ar tm en t of H ea lt h, E du ca ti on , an d W el fa re to g ra n t, u nd er a p p ro p ri at e 48 FOOD ADD ITIV ES circum stances , fu rth er time exte nsio ns with respe ct to food add itiv es which are now being mar kete d und er time extens ions. We are, of course, in com­ plete accord with the purpo se of thi s bill and respe ctful ly urge its passage. The chemica l ind ustr y, as a whole, is in need of add ition al time to full y com­ ply with the requ irem ents of the Food Add itive s Amendment to the Fede ral Food, Drug, and Cosmetic Act. The forego ing notw iths tand ing , however, we wish to sta te tha t, in our view, th e proposed bill, as dra fte d, is, in one respe ct at least, fa r too rest rict ive. H.R. 3980 reads, in pa rt as follo ws: "When ever the Sec reta ry has * * * exte nded the effective da te * ♦ * to March 6, 1961. wit h respe ct to any such pa rti cu lar use of a food additiv e, he may * * * fu rth er exte nd such effective da te * * * wit h resp ect to such use of the add itiv e (or a more limite d specified use or uses the reo f) if * * * he finds (i) th at bona fide action to det erm ine the appli cabil ity of such section 409 to such use or uses, or to develop the scientific da ta nece ssary fo r action unde r such section, was commenced by an inte rest ed person befo re March 6, 1960, and was th ere aft er purs ued wit h reas ona ble diligence. * * *” The proposed bill makes no allowa nce for the gra nt of fu rth er time exten sions in th e ca se of food ad ditiv es, now sold u nde r time extensi ons, wher e no step s l ead­ ing to complia nce wit h the food add itiv es amen dmen t had been ini tiat ed in connection the rew ith on or before March 6, 1960. The prim ary purp ose of this rest rict ion is self-evide nt. II.R. 3980, in effect, rew ard s diligence. However, the languag e of th e bill is such th at it will ha ve the effect also of penal izing companies who f aile d to act pri or to March 1, 1960, in connection with an addit ive, not be­ cause of la ck of diligence, but b ecause no actio n was deemed n ecessa ry. For ex­ ample, cer tai n prod ucts of our ma nuf act ure are, and for many yea rs have been, sold f or use in the p rocessi ng of text iles. We were not, on Marc h 6, 1960, aw are of the f ac t t ha t pa rti cu lar pr oducts in our li ne of te xtil e chemicals w ere used for purpose s which would, or could, brin g them wit hin the scope of the Fed eral act. It was not until imp uriti es were received, subse quent to March 6, 1960, from custom ers fo r thes e p roduc ts, th at we beca me cogniz ant th at they w ere, or could be cons idered as “food add itive s.” Upon rece ipt of such inquir ies, we filed with due diligence, requ ests for time exten sions wit h the Food and Dru g Adm inis tra­ tion in c onnection wit h these p roduct s. It is re spec tful ly s ubm itted t ha t t he propos ed legisl ation, the pu rpose of which is to empo wer t he Sec reta ry of the De par tme nt of He alth , Educa tion, and Welf are to gra nt fu rth er time extensi ons, should per mit the Secr etary th e use of dis­ cretio n in any case havi ng unu sua l circu msta nces . H.R. 3980, as now wri tten , does n ot gr an t the Sec reta ry such dis cre tio nar y power. Rat her, H.R. 3980 will preclud e the Sec reta ry from gra nti ng reli ef undew circu msta nces such as are here tofor e described , to the d etr im ent both of the ind ustr y and the consumer. Your cons ider ation of th is m att er will be app reci ated gre atly. Resp ectful ly, J ohn X. Gammon, Vice P reside nt. E astman Chemical P roducts, I nc., Kingsport, Tcnn., February 2.'/, 1961. Hon. Oren H arris, Chairman, Committee cm Inter state and Foreign Commerce, House Office Building, Washington, D.C. Dear Mr. H arri s: As m ark ete r of a num ber of prod ucts which ar e covered by the food add itiv es amen dmen t to the Food. Drug, and Cosmetic Act. we wish to urge enac tmen t before March 6, 1961. of legis latio n enabling the Secr etary of Hea lth, Educ ation , and We lfare to gra nt exten sions of t he effective dat e of said amen dmen t af te r said date. To thi s end, H.R. 3980 w as intro duce d on Fe bru ary 7. 1961. and ref erre d to your committee. Thi s is a bill sponsored by the Secre­ tary . We wish to u rge its imme date enac tmen t, wit h one change whic h we u nde r­ stan d is agre eabl e to t he Food and Drug Adm inist ratio n. This is, th at inst ead of the requ irem ent th at to qual ify for an extensi on of effective da te af te r March 6. 1961, a food add itiv e must have previo usly been accorde d such an exten sion to March 6, 1961, the sta tu te pe rmit a fu rth er exte n­ sion to March 6. 1961. ha s been gran ted or l ias been reque sted and not denied. FOOD ADDITIVES 49 The reason for immediate enactment of this legislation is stated as follows in lette r from Secretary Flemming to the Speaker of the House dated Jan uar y 13,196 1: "This legislation is needed, both by us and by industry , because we shall not be able to process all food additive petitions under the Food Additives Amend­ ment of 19.58—where extensions have heretofore been gr anted —before March 6, 1961 (th e limit of our present auth ority to gran t extension of the trans ition al provisions) and because the affected industrie s will not be able to develop all necessary scientific d ata and petitions before tha t date even whe re appro priate action leading to such petitions was start ed in a timely manner. Yours very truly, M. C. Stone, As sis tan t Secr etary . T he Dowr Chemical Co., Wash ingto n, D.C., Febr uary 24,1961. Reference H.R. 3980. Hon. Oren Harris, Chairman , Commit tee on Int ers tat e and Fo reign Commerce, U.S. House of R epre sent ative s, Washi ngton, D.C. Dear Congressman H arris : We hereby record our support of II.R. 3980 to amend the Food, Drug, and Cosmetic Act to extend the trans ition period for food additives. We likewise support the proposed change in the wording of the bill to include within its coverage all those food additives for which petitio ns may be pending action by the Food and Drug Administrat ion on the present dead­ line dat e of March 6, 1961. We firmly believe tha t conditions dicta te the grant ing of the relief offered by this proposed legislation to manuf acture rs of food add itives who have acted in good faith in attempti ng to comply with the provisions of the 1958 food add i­ tive amendment, and urge prompt affirmative action by your committee and the Congress in clearing and enactin g this vitally necessary measure. Sincerely yours, Russell A. Whitesell, Specia l A ssi sta nt to the Preside nt. N at ion al C otton Cou nc il of A mer ica , Wash ingto n, D.C. Febr uary 28, 1961. Hon. Oren Harris, Chairman, House Comm ittee on Int er sta te and Fo reign Commerce, New H ouse Office Buil ding , Wash ington , D.C. My Dear Mr. Harris : The National Cotton Council, which is the overall organization of the raw cotton industry, represent ing cotton farmers, cotton ginners, cotton warehousemen, cotton merchants, cotton spinners, and cotton­ seed crushers, favors th e enactm ent of H.R. 3980. As a result of the food additives amendment to the Federal Food, Drug, and Cosmetic Act, rath er extensive tests were required of some chemicals used in cotton production. It wras not possible to complete these tests within the time originally specified and extensions of 1 year were grante d under autho rity con­ tained in the amendment. These extensions expire next month. There are several chemicals which have not yet been approved for cotton production. These are principally defolian ts which faci litate harv est and result in higher grades of cotton. As we unders tand the situation, it is jus t not possible for the Food and Drug Adminis tration and the man ufact urers of some ag ricul tural chemicals to complete the necessary tests required under the food additive s amendment withi n th e time limit allowed. Accordingly, the time extension provided for in H.R. 3980, which you intro ­ duced, seems both reasonable and necessary. The Na tional Cotton Council urges tha t your committee tak e favorable action on H.R. 398 0 promptly. Respectfully submitted. J. B an ks You ng . 50 FOOD ADDI TIVES D ix ie Cu p D iv isi on of A mer ica n C an Co., E as to n, Pa. , F eb ru ar y IS , 1961. Ho n. J am es B. U tt , H ou se Office B ui ld in g, W as hi ng to n, D.C. D ear C ong res sma n U t t : A s yo u a re no do ub t a w ar e, w e ha ve a fa ct o ry in yo ur d is tr ic t in A na he im an d a re th e re fo re ta k in g th e li b er ty of w ri ti n g yo u w it h re fe re nc e to a m a tt e r w hi ch i s of c on si de ra bl e i m port an ce to us. T hi s le tt e r co nc er ns th e 1958 fo od ad dit iv es am en dm en t to th e F ed er al Fo od, D ru g, an d Co sm eti c Ac t. Yo u w ill re ca ll th a t th e g is t of th is am en dm en t is th a t no su bs ta nc e m ay he ad de d to a foo d un le ss it is ge ne ra ll y re co gn iz ed by sc ie n ti st s as ha rm le ss o r h a s be en sp ec ifi ca lly ap pr ov ed by th e F ed er al Fo od a n d D ru g i>eople a ft e r th e su bm is si on of th e re su lt s of e x h a u st iv e s cie nt ifi c te st s. P ri o r to th e pa ss ag e of th is ac t, a s w e un d er st an d th e law , a foo d m an uf ac ­ tu r e r m ig ht us e an y a d d it iv e an d th e bu rd en w as on th e Fo od an d D ru g pe op le to p ro ve t h a t th e a d d it iv e w as h ar m fu l. It is ge ne ra ll y co nc ed ed th a t th e a d d it iv e am en dm en t is a good pi ec e of leg is­ la ti o n an d w as pr ob ab ly ov er du e. H ow ev er, it ha s po sed m an y dif fic ult pr ob le m s fo r th e pa ck ag in g in d u st ry due to th e po si tio n of th e Fo od a nd D ru g pe op le th a t if th e m os t m in ut e tr a c e of a n y th in g fro m a foo d pa ck ag e ge ts in to th e foo d, it is up to th e se ll er of th e foo d th u s pa ck ag ed to d em o n st ra te to th e Fo od an d D ru g pe op le th e e x ac t ch em ic al n a tu re of th e su bs ta nce co nc er ne d an d su bm it ex h au st iv e te st s to th e ef fe ct th a t su ch s ub st an ce is h ar m le ss . T he pa ck ag in g in d u st ry in gen er al ha d bee n at te m p ti n g to ap pl y a com mo n- se ns e ap pr oa ch to th e su b je ct a n d p e rh ap s ha d no t be en too g re at ly co nc er ne d w he n in d u st ry ch em is ts a n d c o n su lt a n ts ad vi se d th a t th e re w as noth in g in th e pa ck ag in g w hi ch co uld di ss ol ve in to th e food in a su ffi cie nt am ou nt to be h a rm ­ fu l. On th e o th e r ha nd , th e re a r e m an y co m pa ni es w hi ch pro du ce fo od pa ck ag ­ ing . ea ch of w hi ch in th e p a s t w as le ft to m ea su re th e pu bl ic w el fa re in th e li gh t of it s ow n et hi cs . T h er ef o re we ag ai n m us t ge ne ra ll y ag re e th a t th e a d d i­ ti ve am en dm en t us ap pl ie d to fo od pa ck ag in g is pr ob ab ly a goo d th in g. T he t es ti n g pr og ra m r eq u ir ed by th e F ed er al F ood a nd D ru g pe op le f or th e c le a r­ an ce of a p a rt ic u la r “a d d it iv e ” is mo st ex ha ust iv e an d th e pr oc ed ur es re ­ qu ir ed f o r th e cl ea ra nc e of a si ng le c he mi ca l or c om po un d m ay co st ov er $100,000. T he on ly p ra ct ic al ap pr oa ch fo r a co m pa ny su ch a s ou rs , w hi ch pur ch as es its m a te ri a ls fr om m an y dif fe re nt so ur ce s, ha s bee n to in si st th a t th e ve nd or s of th e m a te ri a ls in qu es tio n se ll us on ly m at er ia ls w hi ch ha ve be en ap p ro p ri at el y cl ea re d by th e F ed er al Fo od an d D ru g peo ple. In tu rn , be ca us e of th e la rg e ex jie ns e inv ol ve d, m an y su ppl ie rs of our ra w m a te ri a ls su ch as pa pe r, pl as tic s, w ax es , an d ad he si ve s, ha ve u n d e rt a k e n jo in t in d u st ry pro gr am s fo r th e te st in g an d cl ea ra nc e of th e ir m at e ri a ls . T he FD A u n d er st an d s th is an d is in ag re e­ m en t w it h su ch a pr oc ed ur e, sin ce it al so re du ce s FD A m an po w er re quir em en ts if m a te ri a ls a re cl ea re d in a n o rd er ly w ay by gr ou ps w hi ch re p re se n t mo st of th e pr od uc er s in a p a rt ic u la r lin e. T he ad dit iv es am en dm en t gi ve s th e Fo od an d D ru g A dm in is tr at io n po w er to g ra n t c e rt a in ex te ns io ns of ti m e d u ri n g wh ich “u ncl ea re d” ite m s ma y co nt in ue to be us ed if FD A is co nv in ce d th a t th e pu bli c wi ll no t be ha rm ed . A gre at m an y, if no t mo st, co m po ne nt s a re pr es en tly be ing us ed in fo od pa ck ag in g p u r­ su a n t to su ch ex te ns io ns . On e su ch ex am pl e is a pe tr ol eu m w ax wh ich is pr es en tly un de rg oi ng e x h au st iv e te st s un de r th e au sp ic es of th e A m er ic an P e tr o ­ leu m In st it u te . T he a u th o ri ty of th e Fo od an d D ru g A dm in is tr at io n to g ra n t su ch ex te ns io ns an d th e ex te ns io ns her et of or e g ra n te d ex pi re by th e te rm s of th e ad di ti ve am en dm en t on M ar ch 6, 1961. A g re a t m an y in du st ry pro gr am s wh ich a re be ing co nd uc te d in ge ne ra l ha rm on y w it h th e ob jec tiv es of th e Fo od an d D ru g Ad m in ­ is tr a ti o n ca n n o t po ss ib ly be co m pl ete d by M ar ch 6, w hi ch is al m os t ujio n us. T he in du st ry , th er ef ore , m ay be fa ce d w ith a co m pl ete ly ch ao ti c si tu at io n un le ss th e po w er o f th e Fo od an d D ru g A dm in is tr at io n to g ra n t su ch ex te ns io ns is ex te nd ed p ri o r to M ar ch 6 of th is yea r. We u n d er st an d th a t th e Fo od an d D ru g A dm in is tr at io n is re qu es ti ng th a t th is po we r be g ra n te d to it a t le as t fo r ca se s in w hi ch bona fide te st in g pr og ra m s a re un de rw ay an d in w hi ch it fe els th a t th e in d u st ry co nc er ne d is co op er at in g. T he pu rp os e of th is l e tt e r is to ac q u a in t you w ith th e si tu a ti o n an d to st ro ng ly ur ge you to su ppor t an im m ed ia te ex te ns io n of th e a u th o ri ty of th e Fo od an d D ru g A dm in is tr at io n to g ra n t ex te nsi ons as her et of or e ou tli ne d. T he re has bee n a g re a t de al of c on ce rn th a t be ca us e of th e co nf us io n a tt e n d a n t up on th e ch an ge FOOD ADD ITIV ES 51 in ad m in is tr at io n , th is m a tt e r wo uld be ov erl oo ke d. H ow ev er , we be lie ve th a t it is co m pl ete ly n o n p a rt is a n an d we st ro ng ly ur ge th a t yo u a ss is t in an y w ay yo u ca n. Si nc er ely yo ur s, R. U. P in e , Jr ., R es id en t Co un se l. P. S .— Sin ce d ic ta ti n g th e fo re go in g le tt e r it h a s co me to ou r a tt e n ti o n th a t so m e pe op le in ou r in d u st ry fe el th a t th e po w er of FD A to g ra n t ex te ns io ns sh ou ld no t be re st ri c te d to si tu a ti o n s in w hi ch p a rt ic u la r te st in g pr og ra m s a re pr es en tly un de rw ay . (1 ) W e th in k th a t th is in d u st ry po si tio n is so un d. W h e th e r FD A wo uld g ra n t an ex te ns io n in a p a rt ic u la r ca se wo uld st il l be d is cr et io n ar y an d FD A ne ed n ot g ra n t it. H ow ev er , it do es no t see m w is e to so re st ri c t th e po w er of FD A th a t it ca n n o t u n d er a n y ci rc um st an ce s g ra n t a n ex te ns io n in som e m er it o ri o us o r u n us u al ca se in w hi ch no te st in g pr o g ra m is pr es en tly un de rw ay . H ow ev er , a d is p ut e ov er th e e x te n t of au th o ri ty of FD A sh ou ld no t be p e rm it te d to bog do wn th e si tu a ti o n to su ch an e x te n t th a t no le gi sl at io n is fo rt hc om in g be fo re M ar ch 6. T he d is p u te is m in o r; som e le gi sl at io n is in di sp en sa bl e. (1 ) Th e FD A pr op os ed bil l li m it s th e ri g h t of th e S ec re ta ry to g ra n t e x te n ­ si on s to ca se s in w hi ch “h e fin ds (i ) th a t bo na tid e ac ti o n to d et er m in e th e ap pl ic ab il it y of su ch se ct io n 409 to su ch us e or us es , o r to de ve lo p th e sc ie nt ifi c d a ta ne ce ss ar y fo r ac ti on u nd er su ch se ct io n, w as co mm en ce d by an in te re st ed pe rs on be fo re M ar ch 6, 19G0, an d w as th e re a ft e r p u rs ue d w ith re as on ab le di lig en ce .” (Whereupon, at 1 0:50 o’clock, the hearin g was adjour ned.) o