-C

FOOD ADDITIVES—EXTENSION 

OF TRANSITIONAL PROVISIONS

KSU LIBRARIES

O'

ru

c

ru

<0

s

i GOVERNMENT

» ' I Storage . Xn f a

f 7 3 /g H E A R IN G S

BEFORE THE

COMMITTEE ON

INTERSTATE AND FOREIGN COMMERCE 

HOUSE OE REP RESEN TATIV ES

EIGH TY -SE VE NT H CONGRESS

FIR ST SESSION

ON

H .R .3980

A BILL TO AMEND THE TRANSITIONAL PROVISIONS OF 

TII E ACT APPROVED SEPT EMBER 6, 1958, ENTITLED “AN 

ACT TO PROTECT THE PUBLIC HEALTH BY AMENDING 

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO 

PROHIBIT THE USE IN FOOD OF ADDITIVES WHICH HAVE 

NOT BEEN ADEQUATELY TESTED TO ESTABLISH TH EIR 

SAFETY,” AND FOR OTHER PURPOSES

FEBRUARY 28 AND MARCH 1, 1961

Print ed for the use of the Committee on Interst ate and Foreign Commorpo

?

REFERENCE 1

LIBRARY

DEPARTMENT

66738

U.S. GOVERNMENT PRINTING OFFIC E 

WASHINGTON : 1961
I

COMMITTEE ON INTERSTA TE AND FOREIGN COMMERCE

O R EN H A R R IS , A rk a n sa s, C h a ir m a n

JO H N B E L L W IL L IA M S , M is si ss ip pi

P E T E R F. M AC K. J r.. Il li n o is

K E N N E T H A. R O B E R T S, A la bam a

M ORGAN M. M OU LD ER , M is so uri

H A R L E Y O. ST A G G E R S, W est V ir g in ia

W A L T E R R O G E R S, T exas

SA M U EL N. F R IE D E L , M ary la n d

JO H N J . FL Y N T , JR ., G eorg ia

T O R B E R T H. M ACDONALD , M a ssa c h u se tt s

G EO R G E M. R H O D E S, P e n n sy lv a n ia

JO H N JA R M A N , O kla hom a

LE O W. O B R IE N , Ne w Y or k

JO H N E. M OSS , C ali fo rn ia

JO H N D. D IN G E L L , M ic hig an

JO E M. K IL G O R E , T exas

P A U L G. RO GER S, F lo rid a

R O B E R T W. H E M P H IL L , S o u th C aro li n a

DAN R O ST E N K O W SK I, Il li n o is

JA M E S C. H E A L E Y , New Y or k

JO H N B. B E N N E T T , M ic hig an 

W IL L IA M L. S P R IN G E R . Il li n o is 

P A U L F. SC H EN C K , O hi o

J . A R TH U R YOUNGER, C ali fo rn ia 

W IL L IA M H. AVER Y. K a n sa s 

H A R O L D It. C O L L IE R , Il li n o is 

M IL TO N W. G LEN N, New Je rse y 

SA M U EL L. D E V IN E , Ohi o 

A N C H E R N E L SE N , M in nesota 

H A ST IN G S K E IT H , M a ssa c h u se tt s 

W IL L A R D S. C U R T IN , P e n n sy lv an ia 

A B N E R W. SIB A L , C o n n ec ti c u t 

V ER N O N W. TH O M SO N , W is consi n

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 nt Cle rk

P ro fe ss io na l Sta ff

A nd rew St ev en so n Sam G. Sta l

K ur t B oiichardt Mart in W. Cu n n in g h a m

II
C O N T E N T S

Pa ge

Text of H.R. 3980_______________________________________________ 1

Report of Health, Educatio n, and Welfare De partm ent________________ 2

Statement of—

Boyd, George, Jr., counsel, American Paper & Pulp Association_____ 26

Delaney, Hon. James J., a Representative in Congress from the State

of New York______________________________________________ 7

Dunkelberger, H. Edward, Jr., counsel, National Canners Association______________________________________________________ 41

Harvey, John L., Deputy Commissioner, Food and Drug Administration ___________________________________________________ 11

King, Hon. David S., a Representative in Congress from the State of

Utah_____________________________________________________ 9

Larrick, George P., Commissioner, Food and Drug Administration._ 11,37 

Markel, Michael F., food, drug, and cosmetics section, New York Bar

Association______________ _________________________________ 44

Muldoon, Thom as J., technical director, National Paperboard

Association_______________________________________________ 29

Mulford, Kenneth E., chairman, food additives committee, Manufacturing Chemists’ Association, Inc____________________________ 39

Ribicolf, Hon. Abraham, Secretary of Health, Educatio n, and Welfare. 11 

Additional inform ation submitted for the record by—•

Brid gevater Homemakers Ciub, letter from Josephine P. Shively___ 47

Dixie Cup Division of American Can Co., letter from R. D. Pine, Jr.,

resident counsel___________________________________________ 50

Dow Chemical Co., letter from Russell A. Whitesell, special assistant

to the pre sident___________________________________________ 49

Eastman Chemical Products, Inc., letter from M.C. Stone, assistant

sec reta ry_________________________________________________ 48

Food and Drug Administration, letter from George P. Larrick, Commissioner_________________________________________________ 37

Food Law Inst itute, Inc., letter from Franklin M. Depew, presiden t.. 46

National Cotton Council of America, letter from J. Banks Young___ 49

Nopco Chemical Co., letter from Joh n N. Gammon, vice preside nt.. 47

h i

FOOD ADDITIVES—EXTENSION OF TRANSITIONAL 

PROVISIONS

TUESD AY , F E B R U A R Y 28 , 19 61

H ouse or Repr esenta tives, 

Com mittee on I nter stat e and F oreign C ommerce.

IF ashing ton, D.G.

The committee met at 10:30 a.m., pursuan t to notice, in room 1334, 

New House Office Building, Hon. Oren Harris (chairman of tlie committee) presiding.

The Chairman. The committee will come to order.

Today the committee is meeting to conduct hearings on H.R. 3980, 

a bill to provide for the continuation of the a utho rity of the Secretary 

of Health, Education, and Welfare to permit the commercial use of 

certain food additives and pesticide chemicals pending the outcome 

of investigations and scientific studies now in progress by both the 

industries concerned and the Food and Drug Administration to determine, what, if any, tolerance limitations or other conditions should be 

imposed on their use in order to protect the public health.

The Secretary’s authority to permit the continued use of these food 

additives expires March 4, 1961, and with respect to the pesticide 

chemicals the expiration date is March 5,1961.

I have introduced the bill at the request of the Secretary of Health, 

Education, and Welfare and in view of the urgency which has been 

expressed as to the need for its prompt enactment, I have scheduled 

hearings on this bill as the first order of business of the committee 

during this session.

A copy of H.R. 3980, together with the departmental and agency 

reports thereon, will be made a part of the record at this point.

(Documents referred to follow:)

[II.R. 39S0, 87 th Cong., 1st sess. ]

A B IL L To am en d th e tr an si ti o n al pr ov isio ns of th e A ct ap pr ov ed Se ptem be r 6. 195 8, 

en ti tl ed “A n Ac t to p ro te ct th e pu blic he al th by am en di ng th e Fed er al Food, Dru g, an d 

('os m et ic Act to pro hib it th e use in food of ad di tive s which ha ve not been ad eq uat el y 

te st ed to es ta bl ish th eir sa fe ty ”, an d fo r oth er pu rp os es

lie it en ac ted by th e Sen ate and- H ou se of R ep re se nta ti ves of the United S ta te s

o f Am er ic a in C on yress as semb led, T h at th is A ct may be c ited as th e “F oo d Add itive s T ra nsi ti onal Pro vi sion s Amen dm en t o f 1961”.

Sec. 2. Su bsec tio n (c ) of section G of th e Fo od A dd iti ve s Amen dm en t of 

1938 (P ub lic La w 83-92 9, 72 Sta t. 1784, 1788 ) is am en de d by in se rtin g in su ch 

su bs ec tio n, a t th e en d th er eo f th e fo llow in g: “W he ne ve r th e Secre tar .v ha s, p u rsu an t to cl au se (1 ) (B ) of th is su bs ec tio n, ex tend ed th e effecti ve dat e of se ction 

3 of th is Act to M ar ch G. 1961, w ith re sp ec t to an y su ch p art ic u la r use of a food 

ad di tive , he ma y. notw it hst an din g th e par en th eti cal tim e lim itat io n in th a t 

clau se , fu rt h e r ex te nd su ch effecti ve date under th e au th o ri ty of th a t cl au se 

(b u t su bj ec t to clau se (2 )) w ith re sp ec t to su ch us e of th e ad ditiv e (o r a mor e 

lim ited specified us e or us es th er eo f) if, in ad di to n to m ak in g th e fin ding s re ­

quir ed by clau se (1 ) (B ), he fin ds (i ) th a t bo na fide ac tion to de term in e th e ap-
2 FOOD ADD ITIVES

pl ic ab ility of suc h se ction 409 to su ch us e or uses, or to d evelo p th e s cien tif ic data ne ce ss ar y fo r ac tion under su ch se ction, w as comm enced by a n in te re st ed pe rso n be fore M ar ch 6, 1900, an d w as th ere aft er pu rs ue d w ith re as on ab le d ilige nc e, an d (i i) th a t in th e Sec re ta ry ’s ju dgm en t such ex tens io n is co nsi st en t w ith th e ob jective of carr yin g to co mpleti on in good fa it h , as soon as re as on ab ly pra cti ­ cable , th e sc ientifi c in ve st ig at io ns ne ce ss ar y as a ba sis fo r ac tion under such section 409. The Sec re ta ry may at an y tim e te rm in ate an ex te ns io n so gra nte d if he fin ds th a t it sh ou ld not ha ve been gra nte d, or 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 tens io n no long er ex ists, or th a t th ere ha s bee n a fa il u re to comp ly w ith a re quir em en t fo r su bm iss ion of pr og re ss re po rts 

or w ith oth er co nd itio ns attached t o s uc h ex te ns io n. "

Sec. 3. P ara g ra p h (b ) of se ction 3 of th e Nem ato cid e, P la n t Reg ul at or , D ef ol ia nt , an d Des icca nt Amen dm en t of 1959 (P ub lic Law 8(1-139, 73 S ta t. 286, 288) is am en de d by in se rt in g in su ch para gra ph, a t th e end th er eo f, th e follo w­ in g: “W he ne ve r th e Sec re ta ry of H ea lth, Edu ca tion , an d W el fa re has purs uant to cl au se (1 ) of th is para gra ph (b ), pre sc ribe d an ad di tional pe rio d ex pi ring on M arch 5, 1961, w ith re sp ec t to an y su ch p art ic u la r use of a ne matoc ide, pl an t re gu la to r, de fo lian t, or de sicc an t, he may, notw ithst an din g th e prov ision Io th e contr ary in su ch cl au se (1 ), fu rth e r ex te nd th e ex pir at io n dat e ap plicab le un de r su ch c laus e (1 ) (b ut su bj ec t to c la us e (2 )) w ith re sp ec t to such us e of su ch su bs ta nc e (o r a mor e lim ited specified us e or uses th er eo f ,, if, in ad ditio n, to mak ing th e fin ding s re qui re d by clau se (1 ), he find s (A ) th a t bona fide ac tio n to de te rm in e th e ap pl ic ab ility of su ch se ction 408 to such us e or use s, or to de ­ velop th e scientifi c d ata ne ce ss ar y fo r ac tion un der such se ction, w as com­ me nced by an in te re st ed pe rs on be fo re M ar ch 6, 1960, an d w as th ere aft er p u r­ su ed w ith re as on ab le dilig en ce , an d (R ) th a t in th e Sec re ta ry ’s ju dg m en t such ex te ns io n is co nsi st en t w ith th e ob je ct iv e of carr yin g to co mpletion in good fa it h, as soo n as re as on ab ly pra ct ic ab le , th e scien tific in ve st ig at io ns ne ce ss ar y as a ba sis fo r ac tio n un de r such se ction 408. The Se cr et ar y may at an y tim e te rm in ate an ex tens io n so gra nte d if he fin ds th at it sh ou ld no t ha ve been gr an te d, or th a t by re as on of a ch an ge in ci rc um st an ce s the ba sis fo r su ch exte n­ sio n no lo ng er ex is ts , or th a t th ere lias been a fa il ure to comp ly w ith a re quir e­ ment. fo r su bm ission of pr og re ss re port s or w ith oth er c on ditio ns att ac hed to su ch 

ex te ns io n. ”

Depa rtme nt of H ea lt h, E ducation, and W elfa re,

February IM I.

Ho n. Oren H ar ris .

Chairman, Committee on Interstate and Foreign Commerce,

House of Representatives. Washington, D.C.

Dear Mr. C ha irman : Thi s is in re sp on se to y ou r requ es t fo r a re po rt on II R. 

3980. a bill to am en d th e tr ansi ti onal pr ov isio ns of th e ac t ap pr ov ed Se ptem be r 6, 1958. en titled “a n act to pro te ct th e pu blic he al th by am en di ng th e Fe de ra l Food. Dru g, an d Co sm etic Act to pro hi bi t th e us e in food of ad ditiv es wh ich ha ve n ot be en ad eq uat el y tested to es ta blish th eir s af et y, " an d fo r oth er p urpo ses. Thi s mea su re , to be know n as th e Fo od Add iti ve s T ra nsi ti onal Pro vi sion s 

Amen dm en t of 1961, w ould am en d exis ting la w in two re sp ec ts. 1. The pr in ci pa l pu rp os e of th is bil l, w hi ch wo uld be carr ie d out by section 2 of th e bill, is to rem ov e— su bje ct to appro pri ate sa fe guar ds an d li m itat io ns— th e tim e lim it (M ar ch 6. 1961 ) whi ch no w ex is ts on th e au th o ri ty of th is De­ part m ent to po stp on e, whe n ne ce ss ar y an d co nsi st en t w ith pu blic he al th pro te c­ tio n. th e effective d ate of th e key oper at iv e prov isions (se c. 3) of th e Foo d A dd iti ve s Amen dm en t of 1958 (P ub lic Law 85 -92 9) to the Fed er al Food, Dr ug , an d Co sm eti c Act. as ap pl ie d to es ta bl is he d foo d ad di tive s (i.e., th os e in co mmer­ cial us e be fo re Ja n u a ry 1. 1958). The addi tional auth ori ty co nf er re d by th e bil l wo uld ap ply on ly w he re su ch fu rth e r po stpo ne men t beyo nd March 6, 1961, is ne ce ss ar y in ord er to jier in it th e co m pl etio n of ne ce ss ar y in qu irie s or st udie s st art ed b efor e M ar ch 6, 1960, an d ne ed ed as a ba sis fo r det er m in in g w he th er , an d if so under w hat to le ra nc e li m it ati ons or oth er co nd iti on s, co nt in ue d us e of th e ad ditiv e shou ld be pe rm itte d under th e perm anent pr ov isions of Pub lic La w 85-929, or w het her th at law ap pl ie s to th e su bs ta nc e inv olv ed a t all. T hi s legi slat io n is needed, bo th by us, an d by in du st ry , be ca us e we sh al l no t be ab le to proc es s al l food addit iv e peti ti ons under th e Fo od Add iti ve s Am end­ men t of 1958— whe re ex te ns io ns hav e her et ofo re be en gra nte d—bef or e March 6. 1961 (t h e lim it of o ur pre se nt au th o ri ty to g ra n t ex tens ion of th e tr ansi ti onal 

pr ov is io ns) , an d because th e affecte d in dust ri es wi ll no t lie ab le to deve lop al l
FOOD ADDITIVES 3

ne ce ss ar y scientifi c d a ta and pet it io ns be fo re th a t dat e, even whe re appro pri ate 

ac tion le ad in g to suc h pet itio ns w as st a rt e d in a tim el y m an ne r.

2. In or de r to mesh w ith th e ab ov e-men tio ne d am en dm en t, th e bi ll (se c. 

3) wo uld si m ilar ly mod ify th e re le van t tr an si ti o n al pr ov isio n of th e Nem atoc ide. 

P la n t R eg ul at or , D ef ol ia nt , and D es ic ca nt A m en dm en t of 1939 (Pub lic Law 

86-139 , sec. 3 ( b ) ) , which , as th e in dir ec t re su lt of br in gi ng cert ain ag ri ­

cu lt u ra l ch em ic als—i.e., ne matoc ides , p la n t re gula to rs , de fo lia nt s, an d de sicca nts —u nd er th e F edera l In se cticid e, Fu ng icid e, an d Rod en ticide Ac t, had 

th e eff ect of cl as si fy in g su ch ch em icals , ab ou t 30 in nu mbe r, as “p es tici de ch em icals ” un de r th e Fo od , Dru g, an d Co sm etic Act, ra th e r th an as “fo od ad dit iv es. ” 

(P es tici de ch em ical re si du es in or on ra w ag ri cu lt u ra l co mmod ities a re not 

w ithin th e pu rv ie w of th e Fo od Add iti ve s Amen dm en t, but ra th er w ithin th e 

purvi ew ’ of th e e arl ie r Pes tici de Che micals A m en dm en t (P ub lic L aw 83 -518 ) 

to th e Food, Drug, an d Co sm eti c Act. ) A t pr es en t, th is tr ansi ti onal pr ov isio n 

of Pu bl ic La w 86-13 9 is in co ns on an ce w ith th e tr an si ti o n al pr ov isio ns o f th e 

Fo od Add iti ve s A m en dm en t of 1958 (P ub lic Law 85-929 ) ; th is wo uld re m ai n 

tr ue u nde r th e p re se nt b ill.

A de tailed expla nation of th e ne ed fo r enac tm en t of th is bill is en clos ed 

he re w ith.

W e th er ef or e, in view o f th e ne ed f or an d u rg en cy of th es e am en dm en ts, reco mmen d p ro m pt en ac tm en t of t he bill.

We a re ad vise d by th e B ure au of th e Bud ge t th a t th ere is no ob jection to th e 

pre se nt at io n of th is re p o rt fro m th e st andpoin t of th e adm in is tr ati on’s p ro g ra m

Sinc er ely y ou rs,

Abraham R ib ic off , S ecreta ry.

A dd itiona l E xpl anati on of P ropose d F ood Add itives T r a n sit io n a l

P ro vi si ons A m en dm en t of 1961

1. Se ct io n 2 of bil l

The Fo od A dd iti ve s Amen dm en t of 1958 (P ubl ic Law 85-92 9) am en de d th e 

Fed er al , Food, Drug, an d Cos metic Ac t so as to d eem ad u lt era te d —a nd th u s bar 

fr om in te rs ta te co mmerce —a ny so-call ed “fo od addit iv e,” an d food bea ri ng 

or co nt ai ni ng su ch an ad di tive , un le ss th e sa fe ty of th e p art ic u la r addit iv e fo r 

it s in te nd ed use ha d fi rs t lieen es ta bl is he d to th e sa ti sf acti on of th e D epar tm en t 

of H ea lth , Edu ca tion , an d W el fa re an d th e us e of th e ad di tive comp lie d w ith 

to le ra nc e li m itat io ns or oth er co nd itio ns of sa fe us e se t fo rt h in a sa fe ty -c le ar ­

an ce re gu la tion issu ed w ith re sp ec t to th e ad dit iv e by th is D ep ar tm en t.

Bas ically, Pu blic La w 85-92 9 became effecti ve on M arch 6, 1959 (ISO da ys 

a fte r th e date of enactm ent) . How ev er, w ith “r es pec t to an y p art ic u la r comm er ci al use of a food ad di tive , if su ch us e w as m ad e of su ch ad di tive be fore 

Ja n u a ry 1, 1958,” th e pr ohib itory pr ov isions (sec. 3) of Pub lic La w 85-929 — i.e., 

th os e wh ich ha d th e effect of barr in g su ch foo d ad dit iv es from th e in te rs ta te 

m ark et un less pr ev io us ly “cle are d” by th is D ep art m ent— w er e to t ak e eff ect o nly 

a fte r a va riab le a ddit io nal gr ac e pe rio d or, if ear li er , on th e dat e of th e est abli sh ­

m en t of an or de r pa ss in g upon th e sa fe ty of su ch p art ic u la r us e of th e ad di tive . 

T his grac e pe rio d fo r such co mmercially es ta blish ed us es of food ad ditiv es was, 

in ge ne ra l. 1 y ear beyo nd th e ba sic effecti ve d ate (i.e ., M ar ch 6, 1960) ; how’ev er, 

th e Sec re ta ry w as em po wered to ex te nd it fo r as muc h as an oth er year (i.e., 

to March 6, 1961) “on th e b as is o f a fin ding t h a t su ch e xt en si on i nv olves no u nd ue 

ri sk to th e pu blic healt h an d th a t co nd iti on s exis t whi ch nec es si ta te th e pre ­

sc ribi ng of such ad dit io nal per io d” (se c. 6(c ) of Pub lic La w 85 -929 ).

The pu rpos e of th es e grace-i>eriod pr ov isio ns w as to per m it an or der ly ad ­

ju st m en t, on th e p a rt of in te re st ed in dust ri es , as we ll as ou rselv es, to th e new 

re qui re m en ts im po sed by Pub lic Law 85-92 9 in so fa r as food ad di tive s est ablish ed in co mmercial us e l»efore Ja n u a ry 1, 1958, wer e co nc erne d, an d to per m it 

th e affecte d in dust ri es to de ve lop th e in fo rm at io n an d scientifi c d ata ne ed ed 

w ith re sp ec t to su ch addit iv es w ithout m ea nw hi le d isco ntinuin g th e m an ufa ct ure , 

m ar ket in g, an d us e of su ch addit iv es no t pro hi bi te d under pri or law . It w as 

fe lt a t th e tim e th at, in ge ne ra l, a def er re d effecti ve d ate of 18 m on th s from th e 

d ate of e na ct m en t (i.e., M ar ch 6, 1960 ) wo uld suffice fo r th is pu rp os e but 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 rth e r tim e, part ic ula rl y w her e 

ad dit io nal scien tific w or k w as re qu ired , wo uld a ri se ; he nc e th e Sec re ta ry w as 

gi ve n th e ab ov e-qu oted fle xib le au th o ri ty to allow fu rth 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 blic he al th was inv olve d 

in su ch po stpo ne men t. How ev er, follo wing th e pre ce de nt of th e Pes tici de Chem-
4 FOOD ADDITIVES

icals Amendment (Public Law 83-518), Public Law 85-929 set an outer limit 

(i.e., March 6,1961) to such ad hoc postponements.

Under this authority, we have so f ar granted over 3.000 ad hoc postponements 

of the effective date of section 3 of the Food Additives Amendment with respect 

to commercially established uses of food additives. The question whether 

Public Law 85-929 should be amended to enable us to grant furth er postponements beyond March 6, 1961. was raised in Jan uary 1960 in the course of our 

testimony before the House Committee on Inter sta te and Foreign Commerce on 

the Color Additive Amendments of 1960 (which became Public Law 86-618). We 

then expressed the view th at consideratio n of this question was premature but 

tha t, if furth er experience should indicate that the existing autho rity was inadequate, we would submit an appro priate legislative proposal to Congress (p. 81, 

rep ort of hea rings on H.R. 7624). Our experience since then indicates th at the present cutoff date of March 6, 

1961. will in fact operate unfairly in a number of situatio ns in which available 

evidence indicates th at continued use of an additive for limited time will be 

consistent with the protection of the public health, and the inte rested persons 

in industry have exercised due diligence in sta rting and pursuing the necessary 

scientific work, but th at work cannot possibly be completed, let alone acted upon 

by us, before arr iva l of this cutoff date. The scientific problem is accentuated by 

the fac t th at the Food Additives Amendment of 1958 applies not only to substances directly and purposefully added to food but also to so-called incidental 

additives, th at is, substances the inten ded use of which may reaso nably be expected to res ult indirectly in the ir becoming a component or otherwise affecting 

the chara cteristics of fo<xl, though thi s is not the purpose for which they are 

employed. For example, if a food wrapping material contains a chemical th at “migrates” 

from the wrapp er into the wrapped food the chemical is by definition a “food 

add itiv e” unless generally recognized by experts as safe. In many cases, it was 

not known whether certain chemicals long used in food packaging materials 

were in fact “mig rato ry” and thu s “food additives” or, if so, how much of such 

chemicals migrated to and remained in or on the food. In such cases, therefore, 

scientific work was required to determin e these facts. If the chemical was 

dete rmined to be a “food add itiv e” in this defined sense, full pharmacological 

stud ies on laboratory animals were then required to fu rnish the necessary scientific basis on which we would have to r est a determination o f the long-term safe ty 

of the chemical for its use and of the precise conditions und er which such use 

should be permitted.

Whe re the necessary scientific work in process involves long-term pha rmacological studies, there is no way in which it can be expedited. Fo r example, 

we know of a pharmacological study now underway by a responsible pha rmacologist on a serie s of paper sizings, which will not be finished until about 

April 1962. Again, ongoing pharmacological indu stry studies on commercially 

estab lished waxes for use on fruits, vegetables, and food containe rs are not 

exj>ected to be completed by March 6,1961.

Section 2 of the bill—which is the prin cipal pa rt of the bill—would therefore 

authorize us, in cases of this kind, to postpone the effective date of section 3 

of the Food Additives Amendment of 1960 beyond March 6, 1961, to the extent 

th at this is consisten t with public hea lth protection and is, in our judgm ent, 

necessary to complete such scientific work in good fai th. (Th is approach is 

sim ilar in concept to that recently adopted by Congress in the Color Additive 

Amendments of 1960 (Pub lic Law S6-618)). Moreover, the bill would enable 

us to invoke this autho rity only where we have previously granted an extension 

to March 6. 1961 (th e limit of our present autho rity), and necessary inquiries 

or studies were started before March 6, 1960, and since then pursued with 

reasonable diligence. (We do not believe that those who have food additive 

problems but have done little or nothing to solve them should receive special 

consideration .) Finally, as in the ease of the Color Additive Amendments of 

1960. the bill would authorize us to terminate a postponement a t any time when 

we find th at it should not have been gra nted in the first place, or tha t by reason 

of a change in circu mstances the basis for the postponement no longer exists, 

or th at there has been a failur e to comply with a requirem ent for submission 

of progress reports or with other conditions attache d to the postponement.
FOOD ADD ITIVES

2. Section 3 of bill (re neniatocides, plant regulators, defoliants, and desiccants)

Under the Food Additives Amendment of 1958, the definition of the term ‘‘food additive” expressly excludes “a pesticide chemical to the exten t th at it is intended for use or is used in the production, storage, or tra nsp ort ation of any raw agricultura l commodity.” The reaso n for this exclusion is th at the regulation of residues of “pesticide chemicals” in or on raw agr icu ltural com­ modities was alread y adequately provided for from the public-health sta nd ­ point by the Pesticide Chemicals Amendment (Public Law 518, 83d Cong.) to the Federal Food, Drug, and Cosmetic Act. The term “pesticide chem ical” is defined by that amendment as “any substance which * * * -is an ‘economic poison' within the meaning of the Federal Insecticide, Fungicide, and Rodenti- cide Act (7 U.S.C., 135-135( k)) as now in force or as herea fter amended, and 

which is used in the production, storage, or tra nsp ort ation of raw7

 agric ult ural 

commodities.” Originally, the Federal Insecticide, Fungicide, and Rodenticide Act, which established a registr ation system (admin istered by the Department of Agricul­ ture) for “economic i>oisons,” confined th at term, basically, to insecticides, fungi­ cides, rodenticides, and weedkillers. The Nematocide, Pla nt Regulator, De­ foliant, and Desiccant Amendment of 1959 (Pub lic Law 86-139) expanded the definition of “economic poison” in the Insecticide, Fungicide, and Rodenticide Act to include neniatocides, and, also, any substance intended for use as a “plant regulator,” defoliant, or desiccant. As a result, chemicals in these four 

categories, used in the pnxluction of a gricultural crops, w7ere no longer classified 

as “food additives” under the Federal Food, Drug, and Cosmetic Act but were 

automatically classified as “pesticide chemicals.” However, in ord er to permit an orde rly tra nsition for both the Government 

and industry, section 3 of Public Law7

 86-139 provided for tra nsi tional time 

I>eriods, eyed to those specified in the Food Additives Amendment of 1958, du ring which (1) certain civil and crim inal sanctions, etc., of the Insecticide, Fungicide, and Rodenticide Act would not apply, and (2) the adu lteration provisions of the Food and Drug Act anted ating the Pesticide Chemicals Amendment w7ould 

continue to apply to cer tain of thes e products. Thus, section 3(b ) of Public Law 86-139 provides that, with respe ct to any par ticula r commercial use of a nematocide, plant regu lator, defo liant or desiccan t in or on a raw7

 agricultura l commodity, “if such use was made of such 

substance before Janu ary 1, 1958,” the old adultera tion provisions of the Food and Drug Act shall continue to apply until March 5, 1960, or until the end of such additional i>eriod, not beyond March 5, 1961, as the Secretary of Health, Education, and Welfare may presc ribe “on the ba sis of a finding tha t conditions exis t which necessitate the prescribing of such additio nal period.” (If, however, a tolerance or exemption therefrom under the Pesticide Chemicals Amendment, i.e., section 40S of the Food and Drug Act, were sooner established for such 

use of the substance, this tradition al period w7ould end at that time with respect 

to such use). The p rese nt bill would amend section 3(b ) of Public Law 86-139 so to enable the Secretary of Health, Education, and Welfare to postpone the cutoff date of March 5, 1961, on an ad hoc basis w’here necessary for completion of scientific work, subject to safe gua rds and limitations exactly paralle l to 

those contained in section 2 of this bill w7hich amend the tran sitional provisions 

of the Food Additives Amendment of 1958. This autho rity is needed in order to make possible the bona fide completion of needed scientific studies that ca nnot 

be completed by M arch 5, 1961.

Changes in exis ting law7

 made by bill to amend the transitional provisions 

of the act approved September 6, 1958, entitled “An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adeq uate ly tested to esta blish their safety,” and for other purposes, are shown as follows (existing law in 

which no changes are proposed are show7n in ro man ; new ma tter is printed in 

ital ic) :

1. F ood Additives Ame nd me nt of

(Pub lic Law 85-929)

“Sec. 6. (a) Except as provided in subsections (b)

this Act shall ta ke effect on the date of its enactment. . “(h) Except as provided in subsection (c) of this sectwif^eOTiOT'ffT$r Act shall take effect on the one hundred and eightieth da k after the dafKi 

enactmen t of this Act.

667 38— 61 ------ 2
6 FOOD ADDITIVES

“ (c ) W ith re sp ec t to a ny p art ic u la r co mmercial u se of a foo d ad di tive , if s uch 

us e w as mad e of such ad dit iv e be fo re Jan u ary 1, 1958, se ction 3 of th is Act 

sh all t ak e eff ect—

“ (1 ) eit her (A ) one y ear a ft e r th e effecti ve date es ta blish ed in su bsection (b ) of th is section, or (B ) a t th e end of su ch ad ditio nal pe rio d 

(h ut no t la te r th an tw o years fr om su ch effecti ve d ate es ta bl ishe d in su bsection (b )) as th e Sec re ta ry of H ea lth, Edu ca tio n, and W el fa re may pre ­

sc ribe on th e ba si s of a fin ding th a t such ex te ns io n invo lves no un du e 

ri sk to th e pu blic hea lth an d th a t co nd iti on s exis t which ne ce ss itat e th e 

pr es cr ib in g o f s uc h an a ddit io nal pe rio d, or

“ (2 ) on th e d ate on which an ord er w ith re sp ec t to su ch us e under section 

409 of th e Fed er al Food, Dru g, an d Co sm etic Act become s effective, 

w hi ch ev er date first oc cu rs. Whenever the Secretary has, purs uant to clause

(1 )( B ) of this subsection, extended the effective date of section 3 of this

Act to March 6, 1961, with respect to any such particula r use of a food additive, he may, notwithsta nding the pare nthetical time limitation in tha t clause,

furth er extend such effective date under the authority of that clause (but,

subject to clause (2) with respect to such use o f the additive (or a more limited

specified use or uses thereo f), if, in addition to making the findings required by

clause (1 )( B ), he finds (i) that bena fide action to determine the applicability

of such section 1/09 to such use or uses, or to develop the scientific data necessary

for action under such section, was commenced by an inter ested person before

March 6, 1960, and was therea fter pursued with reasonable diligence, and (ii)

tha t in the Secretary's judgme nt such extension is consistent with the objective

of carrying to completion in good faith , as soon as reasonably practicable, the

scientific investiga tions necessary as a basis for action under such section 1/09.

The Secretary may at any time term inate an extension so granted if he finds

that it should not have been granted, or that by reason of a change in circum ­

stances the basis for such extension no longer exists, or that there has been a

failure to comply with a requirement for submission of progress reports or with

other conditions attached to such extension.”

2. Nematocide, Plant Regulator, Defoilant, and Desiccant Amendment of

1959

(P ublic La w 8 6-1 39)

“Sec. 3. Thi s Ac t sh al l ta ke effect on th e dat e of its en ac tm en t, ex ce pt th a t— 

“ (a ) w ith re sp ec t to an y ne matoc ide, pla nt re gul at or, de fo ilan t, or de siccan t which w as m ar ket ed co m m er ci ally pri or to th e d ate of en ac tm en t an d 

who se us e do es not re su lt in re si due s of sa m e re m ai nin g in or on a food, 

an d w ith re sp ec t to an y ne matoc ide, pla nt re gu la to r, def oilan t, or de sicc an t 

who se us e does re su lt in re si due re m ai nin g in or on a foo d a t th e tim e of 

in tr oduct io n in to in te rs ta te co mmerce an d wh ich us e had co mmercial ap plica tion pri or to Ja n u a ry 1, 1958, se ct io n 3, “P ro hib ited A ct s” ; se ction 8, 

“P en al ti es ” ; section 9, “S ei zu re s” ; an d se ction 10, “Im port s” , o f th e Fed er al 

In se cticid e, Fu ng icid e, an d Rod en tici de Act, which th is Ac t am en ds , sh al l 

no t be ap pl ic ab le u nti l—

“ (1 ) M arch 5, 1960, or su ch la te r dat e, no t beyond M ar ch 5, 1961, as 

th e Sec re ta ry of A gri cu lt ure may pr es cr ibe on th e ba si s of a de ­

te rm in at io n th a t su ch a ct io n will not b e un du ly d etr im enta l to th e pu blic 

in te re st and is n ec es sa ry to av oi d har dsh ip s, o r

“ (2 ) th e date on which a re gis tr ati on fo r su ch us e is issu ed und er 

th e F ed er al Ins ec tic id e, F un gi ci de , and R od en tic ide Act, 

w hi ch ev er d ate f ir st occu rs : an d

“ (b ) w ith re sp ec t to a ny p art ic u la r co mmercial us e of a ne matoc ide, pla nt 

re gul at or, de fo lian t, or des ic ca nt in or on a ra w ag ri cu lt u ra l co mm od ity , if 

su ch us e w as m ad e of s uc h su bst an ce be fo re J a n u a ry 1, 1958, section 406(a ) 

and cl au se (2 ) of se ction 402(a ) of th e Fed er al Fo od , Drug, an d Co sm etic 

A ct as in fo rc e pri or to th e d ate of th e en ac tm en t of th e Act of Ju ly 22, 

1954 (68 Sta t. 511) (r ela ti n g to p es tici de c he micals on ra w ag ri cu lt u ra l com ­

m od itie s) sh al l a ppl y u n ti l—

“ (1 ) M arch 5, 1960, or th e en d of such ad ditio nal pe rio d, not beyon d 

M ar ch 5, 1961, as th e Sec re ta ry of H ea lth, Edu ca tion , an d W el fa re ma y 

pre sc ribe on th e ba si s of a fin ding th a t such ex tens io n invo lves no un du e 

ri sk to th e pu blic hea lth an d th a t co nd iti on s exis t which ne ce ss ita te 

th e p re sc ribi ng of su ch a n a ddit io nal p eriod, o r
FOOD ADDITIVES Z

“ (2) the (late on which an order with respect to such use under sec­ tion 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) 

becomes effective,

whichever date first occurs. Whenever the Secretary of Health, Education,

and. Welfare has, pursuant to clause (/ ) of this paragraph, (&). prescribed an additional period expiring on March 5, 196J, with respect to any such particular use of a nematoeide, plant regulator, defoliant, or dessicant, he may, notwithsta nding the provision to the contrary in such clause (I ), fu r­ ther extend the expiration date applicable under such clause (1) (bu t suInject to clause (2)) with respect to such use of such substance (or a more limited specified use or uses thereo f), if, in addition to making the findings

required by clause (1), he finds (A) that bona fide actio n to determine the

applicability of such section JfilS to such use or uses, or to develop the scien­ tific data necessary for action under such section, was commenced by an interested person before March 6, I960, and was ther eafter pursued with reasonable diligence, and (B) that in the Secretary's judgm ent such ext en­ sion is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary as a basis f or action under such section 1/08. The Secretary may at any time terminate an extension so granted if he finds that it should not have been granted, or that by reason of a change in circumstances the basis for such extension no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions

attached to such extension.”

The Chairman. I observe, first, that we have a couple of our colleagues 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. Secretary, 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 for the contribution he has made to the problem, the Honorable James 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.

STATEM ENT OF HON. JAM ES J. DELANEY, A RE PR ES EN TA TIVE IN 

CONGRESS FROM TH E STATE OF NEW YORK

Mr. Delaxf.y. Thank you. Mr. Chairman.

Mr. Chairman, I appreciate the opportunity to give my views on 

II.It. 3980, and I shall be very brief. The Food Additives Amendment of 1958 was a significant step for­ ward in the protection of the safety of our food supply. As you know, it was the end result of an intensive investigation of the use of chemi­ cals in foods by a select committee of the House, of years of effort by dedicated scientists and representatives 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 strengthened rathe r than relaxed. All of us have a serious responsibility in this field. Nevertheless, I realize that a law as fa r reaching as the Food Addi­ tives Amendment of 1958 presents problems to many of the industries affected by it. While I deeply regret that it has apparently 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 supply 

into chaos by an abrupt and arbitrary withdrawal of them.
8 FOOD ADDITIVES

I have no qu arr el with the p rin cipa l p urposes of H.R. 3980. Accor din g to its terms, a com pan y th at can show th at it has seriou sly and 

dilig en tly a tte mpted to comply wi th the provisions of the law, bu t w as 

unable to com plete its effo rts by Marc h 6, 1961, may be gr an ted an 

extension o f tim e by th e S ec retar y of H ealth , E du catio n, and W elf are , 

if he finds th at the re is no u ndue risk to the public health. Th e Food 

an d D ru g Ad minist ratio n assure s me th at no extension will be granted 

in any case where u ndue ri sk is involved.

I un de rst an d th at some indu str ies object to th is req uir em ent, and 

Fra nk lin M. Depew , p resid en t o f t he Fo od Law In stitut e, h as been re ­

po rte d as sayin g th at chemicals sho uld not be ba rred ju st because of 

lack o f di ligence on th e p ar t of the supplier.

It is ag ain st attit ud es like thes e th at we m ust be on the ale rt. Ce rtainly, I w ould vigorou sly oppose any legislation th at did not pro vid e 

at least these min imum safeguards .

My ma in objection to II.R . 3980 is th at it pe rm its “op en end” time 

extensions. I st rong ly believe th at a t the most a 2 -ye ar tim e exten sion 

sho uld be gran ted, and th at the new cutoff da te fo r those cases th at 

come wi thin the p urvie w of this bill should be no la te r th an Ma rch 5, 

1963.

Ju dgin gby past, at titud es, un less this is spelled ou t in the leg islation, 

ma ny com panies will star t dr ag gi ng th eir feet, an d the res ult will be 

th at the 1958 ena ctm ent will f all fa r short of its objectives.

I f it is argue d tha t a 2-year extension is not en ough, th en I say, “L et’s 

look at the sit ua tio n again in 2 years.” If , at the end of t hat time, it 

can be proven th at a fu rthe r exte nsio n is needed in some cases, we can 

then decide w hat ac tion to take.

Mr. Ch air ma n, ha ving won grou nd in our fight to pro tec t the consum er, w ecan afford no re tre at. An open end bill wou ld be a re tre at.

II.R . 3980, w ith the in clusion of a cutoff date of Marc h 5, 1963, would 

be en tirely fa ir to indu str y, and, together with othe r safegu ards al ­

rea dy in it, would offer the public some assurance th at its pr op er inter ests are o f conti nu ing conce rn t on s.

I urge th at the bill be amend ed to t hat effect.

Th e Chairm an. Th an k you very much , Mr. De lan ey, for yo ur 

statem ent.

Mr. William s, do you have any question s ?

Mr. W illiams. I hav e no questions.

Th e C hair man. Mr. Schenck?

Mr. S chenck. Xo questions.

Th e C hairman. Mr. Roberts?

Mr. R oberts. X o questions.

Th e C hairman. Mr. Yo unger ?

Mr. Y orNGER. Xo questions.

Th e Chairman. Mr. F rie de l ?

Mr. F riedel. Xo questions.

The Chairm an. Mr. Avery ?

Mr. Avery. Xo questions, bu t I would like to th an k ou r colle ague 

fo r giving us the benefit of his judg men t on this matter, because we 

look to h im fo r advice in this w hole area.

Th e Chairman. Do any of ou r colle ague s have an y questions?

Mr. Delaney, you seem to hav e mad e yoursel f very cle ar to the 

members of th is committee in view of the fact there are no questions 

abo ut a technical problem like this.
FOOD ADDITIVES 9

I would like to ask one question. Suppose you had a substance th at 

has not yet been declared to be a food additive, but at some later date 

is declared to be a food additive. Should the affected industry be 

given time for investigation to determine the safety of this substance?

Mr. Delaney. This deals only with the 3,000 petitions tha t the 

Food and Drug Administration has before it. Any new additive 

must meet the requirements of the law, or anything not included up 

to this date. This deals with only those that are known and on the 

books where there has been insufficient time to test.

The Chairman. I realize that. Sometimes it disturbs me a little 

bit, though, to say tha t a substance after a great effort has 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. 

What happens then ?

Mr. Delaney. I think in those cases that we could take another 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-year 

testing period there were 2,500 that had been acted upon one way or 

the other, and there were 400 or 500 th at needed additional time.

If the petitioners could show to the satisfaction of the Food and 

Drug Administration tha t they need more time, we could come in 

here and I do not know that there would be any objection on my part 

at th at particu lar time.

The Chairman. Thank you very much. We appreciate your 

testimony.

Mr. Delaney. Thank you, sir.

The Chairman. We are also glad to have with us this morning our 

colleague, the Honorable David S. King.

Mr. King, we appreciate your interest in this problem and we are 

very glad to have your test imony.

STATEMENT OF HON. DAVID S. KING. A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF UTAH

Mr. King. Thank you, Mr. Chairman and members of the committee, I have a short statement which is being distributed consisting of 

only three paragraphs. Mr. Delaney has covered practically all o f the 

material contained in my statement, and in order to conserve time, 

therefore, I should like to read just the concluding paragraph of my 

statement, asking that the entire statement be included in the record.

The Chairman. Without objection, the entire statement will be included in the record.

Mr. King. I appreciate the opportunity of appearing before this 

distinguished committee to give brief testimony on the matter of 

further extending the effective date beyond March 6, 1961, for the 

scientific investigations necessary under section 409 of Public Law 

85-929, which investigations are designed to safeguard the health of 

the American public by requiring tha t food additives be adequately 

tested by the manufacturers before being authorized for human consumption.

In view of the fact th at many additives had been in common use before the enactment of Public Law 85-929 by the 85th Congress, the 

manufacturers of such additives were granted what was considered
10 FOOD ADDITIVES

to be a reas ona ble time in whi ch to com plete the scientific testi ng requ ire d by the law. Experience has now proven th at the time allowe d 

was not sufficient, in ma ny cases, to com plete the req uir ed tests, and 

H. R. 3980 prop oses th at the Se cretary be autho rized to gr an t exten ­

sion s as necessary fo r the com pletion of tests which hav e been un de rtaken an d carried out wi th reasonable diligence on the part of ma nufacturers. We con sider it reason able th at necessary extensions be granted, 

but we would obje ct strongly to any acti on which might weaken the 

enf orc em ent of this hig hly i mpo rta nt act. In o rder th at the Congress 

might review the pro gre ss mad e by the Secre tary in the enf orcement 

of the pro vision s of P ub lic Law 85—929 an d continue its interest in the 

pro tec tio n o f the he alt h o f th e A me ric an people, we str on gly urg e th at 

the tim e exte nsion gr an ted to m an uf ac turers fo r testi ng be fixed at 

Marc h 6, 1953, ra th er th an gra nt the Secre tar y open-ended au thor ity 

fo r the gr an ting of extensions to manufacturer s.

Ju st in c onc luding, M r. Ch air man, m y fee ling is t hat th e public law 

whi ch we are con siderin g, 85-929, constitu ted a hig h wa ter ma rk, a 

historical lan dm ark, in the course of legisla tion deali ng with pure 

foods. We feel th at it would be ext rem ely hazar dous at this tim e to 

do an yt hi ng which might weaken the enforcement of th is .act. We 

realize (h at a certa in am ount of plas tic ity is necessary . We do not 

object to tha t. How ever, gr an ting an ope n-end exte nsion, we feel would be goi ng 

beyond reas onable ela sticity and th at it would resu lt in weake ning th e 

basic law itse lf. May I say, also, th at I should like to associate myself com pletely with the r em arks of th e distinguished g entlem an from 

New York, M r. Delaney , whom I con sider to be one of th e g reat heroes 

in th is fight to ma intai n and preser ve pure food fo r the Am eric an 

public.

Tha nk you.

The Chairman. Th an k you very much, Mr. King, fo r yo ur sta tement. We appreciat e ha ving yo ur expression of inter est in this 

legisla tion .

Ar e the re any questions?

Mr. Avery. I ha ve just one.

Th e C hairman. Mr. A very.

Mr. Avery. Mr. Ki ng , you mad e a reference as to “weak ening of 

thi s bil l.” Do y ou con sider a sim ple extension of tim e as mate ria lly 

or sub sta ntial ly w eak ening the bill or the sta tute in a ny wa y ?

Mr. K ino. As I a tte mp ted to po int out, I think that in jecting a li ttl e 

ela sticit y into the bill would no t weaken it. I think the wea ken ing 

comes when the ela sticity is str etc hed beyond reason able limits. I 

feel th at g ra nt in g an open-en d exte nsio n here would lie carryi ng it too 

far. Tha t. I think, wou ld lie weakening it. I would not object to 

pla cin g a 2-y ear lim ita tio n, and as Mr. Delaney pointed out. If at 

the e nd of that 2 year s, we still hav e a prob lem, we can reexam ine it 

and p erha ps have a f urther extensio n at that time.

Mr. ? very. Th an k you.

Mr. K ino . Th an k you.

T he C hairma n. An y fu rther questions?

Tha nk you very much. Mr. King.

Mr. K ing. Th an k you.
FOOD ADDITIVES 11

The Chairman. We are now gratified to have with us this morning 

for the first time a former colleague of ours, who has now the distinc­ tion, and privilege, and high honor of serving in the position of 

Secretary of Health, Education, and Welfare. In view of the fact tha t we have many problems being administered by your Department, Mr. Secretary, we are exceedingly glad 

to have you with us this morning for the first time. 1 am sure that 

we shall be looking forward to more meetings with you in connection 

with legislation which your Department will be involved in. I am 

particularly glad that you were able to meet with us today in view of the fact that this is the first hearing that the committee has scheduled and conducted in this session of Congress. Furthermore, we appreciate you being here in order to renew your acquaintance with 

some of us who served with you in the Congress when you were here 

and to meet those who did not have that 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 with some of the testimony here this morning. 

At the outset, I think, it would be helpful if you would identify the 

associates with you here this morning in order that the committee 

may know them and they, of course, may know the committee better.

STATEM ENT OF HON. ABRAHAM RIB ICO FF, SECRETARY , DE PA RT ­

MEN T OF HEAL TH , EDUCATION, AND W ELFA RE; ACCOMPANIED

BY GEORGE P. LARRICK , COMMISSIONER, FOOD AND DRUG AD MINIST RA TIO N; AND JOH N L. HARVEY, DEPUTY COMMISSIONER,

FOOD AND DRUG AD MINIS TRATION

M?. Ribicoff. Thank you very much, Mr. Chairman, for your 

gracious remarks.

It is really a pleasure to come here and renew my acquaintanceship 

with you, Mr. Chairman and many of 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. Congressman Sibal of Connecticut was Republican leader in the Connecticut General Assembly during my term of governorship and Congressman Thomson was a fellow Governor from Wisconsin, who I respected so 

much in our working together in various Governors’ conferences.

I am very interested to find that some of the most important work of health, education, and welfare comes within the jurisdiction of this 

most important committee. Some of these programs are of great importance for the future of our Nation and I look forward to lieing here many, many times to testify before this committee. I would hope 

tha t at any time any member of th is committee personally might have a problem, or a question, or an inquiry concerning anv parts of mv 

Department, you would not hesitate to pick up the telephone and call 

me and we will try to get the replies to you as fast as possible.

I did think that since this is a new administration, I would like to 

introduce to you the top people in this Department who will be here in addition to myself and who will be working with this committee: 

Mr. Ivan A. Nestigen, Under Secretary, Mr. Wilbur Cohen, Assistant Secretary, Mr. James Quigley—a former colleague of yours—
12 FOOD ADD ITIVES

Assistant Secretary, Mr. Boisfeuillet Jones, Assistant for Medical A ffairs, and Mr. Alanson Willcox, General Counsel. I believe you all 

know Mr. Larrick and Mr. Harvey, who are career men in this particular field.

Mr. Chairman and members of the committee, I appreciate the opportunity to discuss with you the proposal for legislation to authorize 

further extensions of the date on which the food additives and pesticide 

chemical amendments of the Federal Food. Drug, and Cosmetic Act 

will become effective. The two pertinen t statutes were to have become 

effective on March 5, 1960, but in each case there was a provision for 

administrative action to extend the effective date to March 5, 1961, on 

a showing that the extension was necessary and tha t the particular use 

involved would present no undue hazard to the public during that 

period.

You will recall tha t early last year, representations were made to 

this committee that the 1 additional year provided in the statute would 

not be sufficient. At tha t time, my predecessor, Secretary Flemming, 

urged th at the food additives amendment be permitted to stand with a 

clear understanding that if experience demonstrated the need for further extension beyond March 5, 1961, the Department would so advise 

this committee.

In the field of food additives real progress has been made during 

these past 12 months. Industries involved have worked intensively 

in endeavoring to solve their problems and obtain the necessary data 

on which suitable regulations can be based to permit the continued 

use of substances which can be shown to be safe for the public at 

large.

The Food and Drug Administration advises me that despite the 

diligent work of the industries and this Department, there is a real 

need for the authority for fur the r extensions as outlined in H.R. 

3980. The bill includes safeguards to prevent dilatory tactics, but 

the keystone of any extension which could be granted under the 

authority of this bill is in the requirement for a showing that the 

extension will not present any undue hazard to the public health.

It is not planned that blanket extensions will be granted for a 

single period. Instead, the fact in each case must be taken into consideration. No more time should be authorized than is necessary 

to obtain the required data on this matter of safety for permanent 

usage of the particular item involved, whether it be a direct additive 

or one which becomes a part of the food through migration of packaging or plan t equipment components.

If at any time a question of safety arises while an extension is 

effective, the bill authorizes immediate termination of tha t extension 

where the facts warrant such action.

The situation with respect to the pesticide portion is a comparable 

one applying only to nematocides, plant regulators, defoliants, and 

desiccants. A limited number of substances are involved here, but 

there has been shown to be need for further time to enable industry 

and agriculture to acquire the data the scientists of the Food and 

Drug Administration feel is necessary before formal regulations can 

be granted.

Air. Larrick is prepared at any time to provide specific inform ation on developments under this food additives amendment. I do 

believe t ha t this bill is in the interest of the Government, consumers.
FOOD ADDITIV ES 13

and the affected industries and respectfully request a favorable 

report.

Mr. Larrick, who is the Commissioner of Food and Drug, is here, 

gentlemen, to supply any detailed information. He has been working 

in this field during these years, and is certainly better acquainted 

at this time with the details than I am, and if there are any questions, Mr. Chairman, I do believe tha t Mr. Larrick could supply 

the details to you, Mr. Chairman, and the members of the committee.

The Chairman. Mr. Secretary, thank you very much for vour 

statement.

Mr. Larrick, do you have any further comments to make?

Mr. Larrick. Mr. Harris , I would like to tell the committee which 

passed this 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 what has developed under 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 additives amendment of the Federal Food, 

Drug, and Cosmetic Act is unquestionably a most important addition 

to the laws designed to safeguard the food supply of this country. 

Though not yet fully in effect, it has already brought about great improvements in the production and handling of food; because of the 

amendment the American consumer is receiving greater protection 

than was possible before. As you know, the amendment requires the 

person who wishes to 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 ingredients of food has covered not only substances added directly to food, but also substances which get into food 

in other ways, as from food handling equipment and food wraps.

Since September 1958, the Food and Drug A dministration has done 

much to implement this consumer protection. We have handled over 

4,200 formal requests for information or review of d ata on food additive problems. We have engaged in hundreds of informal discussions 

with industry to explain and explore the administrative and technical 

requirements of this law. We have published lists of 718 chemicals 

used with foods which are generally recognized as safe by appropriately qualified scientists, and thus are exempt from the application of 

the food additives amendment.

We have published lists of 112 substances that, have prio r sanction 

and thus are exempt from the food additives amendment.

We have received 391 petitions for food additive regulations. Of 

these: 100 were not complete enough to be filed; 42 did not relate to 

food additives; 178 are being actively evaluated; 59 led to the issuance 

of regulations stating safe conditions for using and additives involved; 

and a few petitions were withdrawn after filing.

The 391 petitions received thus far have involved over 1,900 uses of 

chemicals in food production, processing, or handling.

To permit an orderly transition, the food additives amendment gave 

us authority to extend the date upon which the law would become 

fully effective with respect to an additive for a maximum of 30 months

66738— 61 3
14 FOOD ADD ITIVES

from the date of enactment, th at is, to March 5, 1961, provided the extension is necessary and “involves no undue risk to the public health.”

In accordance with this authority, 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, and we have about 50 requests for 

additional extensions whose processing awaits the submission of more 

data.

In 1958, when the food additives bill was before this committee, we 

believed tha t a 30-month transition period would be long enough to 

permit resolution of the principal problems that would arise. It is now 

evident tha t this was not enough time. In large measure this is due 

to the fact that the problem is much larger than anyone realized in 

1958. An occasional expert may have had a good idea of the number 

of chemicals being used in his particu lar industry, but no one person 

was in a position to know of the vast number of uses of food additives 

in the entire food field tha t would need to be cleared under the new law.

So there are numerous food additives being employed today to the 

benefit of consumers and industry which still require clearance. And 

we have no authority under the law to gran t time beyond March 5 of 

this year.

We believe that it would be in the public interest to amend the food 

additives law to permit further extensions of its effective date under 

circumstances tha t will safeguard the public health. Our Dep artment d rafted the bill which is before you as II.R. 3980 to accomplish 

this.

The safeguards in II.R. 3980 are important. The principal ones 

are:

1. We could grant further extensions only for products and uses 

that were being commercially employed before Janua ry 1,1958. This 

provides a background of experience tha t lends support to the decisions of our scientists tha t continued use fo r a limited time will not 

jeopardize the public health.

2. We could gra nt further extensions only where conditions exist 

which necessitate the prescribing of an additional period.

3. We could gra nt further extensions only for additive uses that 

already have been granted extensions to March 5, 1961, o r under an 

amendment which I will discuss in a moment, for uses fo r which requests for extension are pending on tha t day. This precaution is 

desirable to guarantee tha t the auth ority for further extensions does 

not serve as an excuse for inertia and inactivity by the affected 

industries.

Some could interpret the absence of such a safeguard as an in vitation to wait for the Government to determine that their use of a chemical employed before 1958 is in fact subject to clearance under the food 

additives amendment, a t which time they could come in and forestall 

appropriate legal action by pressing for an extension of the effective 

date of the amendment, de novo. This clearly would defeat the p urpose of the law.

There is clarifying language that would improve the bill as originally drafte d and submitted to the Congress: there are a few instances 

in which firms took timely action to determine the status of their products under the food additives amendment, but final action on their 

requests for extension has not yet been taken. To take care of such a 

situation, we recommend tha t H.R. 3980 be amended by adding on
FOOD ADDITIVES 15

page 2, immediately after line 3, and on page 3, line 8, immediately 

after “1961,” the following, “or has on tha t date a request for such 

extension pending before him.”

4. Another safeguard is the proposed requirement tha t before 

grantin g further extensions we must find t ha t bona fide action was 

taken to determine the applicability of the food additives amendment 

to the use for which extension is requested or to develop the scientific 

data necessary for action under the amendment. In the absence of 

such a provision, a firm that had taken no steps to determine th at its 

products were in compliance with the food additives amendment could 

argue, when it learned th at the Government was investigating its pro ducts, tha t it should be granted a period of time in which to conduct 

studies of its own.

5. The bill would allow only those extensions that in our judgment 

are consistent with the objective of carrying to completion in good 

faith, as soon as reasonably practicable, the scientific investigations 

necessary as a basis for action under the food additives amendment.

6. The bill would allow us to tenninate an extension tha t we find 

should not have been granted, one which was proper when granted 

but is no longer justified by changed circumstances, or one where 

there is failure of the person who secured the extension to meet conditions attached to it.

H.R. 3980 would apply equally to a small group of agricultural 

chemicals (nematocides, pla nt regulators, defoliants, and desiccants) 

that were food additives until Public Law 86-139 resulted in their 

being classed as pesticide chemicals in 1959. Until such time as 

their status can be definitely detennined, they should receive the same 

consideration as though they had not been shifted from the food 

additive classification.

The bill follows the pattern of the color additive amendments of 

1960 (Public Law 86-618) in that 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 items can be handled 

within a few additional weeks or months, while some may require 

considerably more time.

The planning and execution of the various tests contemplated by 

the food additives amendment is a time-consuming operation. In our 

own laboratories, for example, it takes approximately 3 years from 

the time we first decide to subject a chemical to chronic toxicity testing until the results of the tests are summarized and available for 

adminisrative review. And this assumes tha t nothing unusual develops to require a report test or a more extensive investigation.

To summarize, we now know that if the food additives amendment 

becomes fully effective on March 5, 1961, it will seriously disrupt established practices in the food industry tha t are of benefit to the consumer. There is no indication th at such disruption is required to protect the public health. H.R. 3980 would permit a more orderly tra nsition to the time when the food additives amendment is fully in effect, 

and, meanwhile, would protect the public health by sound safeguards.

The Chairman. Commissioner, thank you very much for your statement on the progress and status of this important matter before your 

Department. We appreciate having the testimony of you, Mr. Secretary, along with Commissioner Larrick. I think under the cir-
16 FOOD ADD ITIVES

cumstances, it would be appropriate, in view of your statement, Mr. 

Secretary, to first recognize Mr. Thomson for any comment or questions he may have of either the Secretary or the Commissioner.

Mr. Thomson. No; I have none.

The Chairman. Mr. Sibal ?

Mr. Sibal.. No, Mr. Chairman.

The Chairman. I would say tha t obviously you were convincing.

Mr. Williams?

Mr. Williams. Mr. Chairman, first, I would like to join the chairman and other members of the committee in welcoming our old friend 

Secretary Ribicoff back to Washington. We look forward to working with you, Mr. Secretary, during your term of office. I do not 

believe, Mr. Commissioner, th at you covered the suggestion made by 

Mr. Delaney regarding the possible amending of this bill to do 

away with the so-called open-end approach. Would you like to discuss that?

Mr. Larrick. Air. Williams, if you and your committee are willing 

to take this up again in 2 years, if it is necessary, on the same rush 

basis that 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. Williams. Do you feel that it is necessary in order to protect the public interest ?

Air. Larrick. I feel if we were given the authority to decide it, we 

would decide it right, but I am not going to argue against Air. 

Delaney and Air. King.

Secretary Ribicoff. I think, Air. AVilliams, in talking with Mr. 

Larrick—and you appreciate I would have to rely at this stage on his 

judgment and experience—it is Air. Larrick’s feeling that a more 

realistic approach would be 3 years.

However, I do appreciate the fact of Congressman Delaney’s efforts, 

because I do recall it was some 10 years 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 here 2 veal’s from 

now, and we would certainly defer to the judgment of this committee, but the Food and Drug Commissioner and his Department feel 

tha t 3 years would be more realistic. However, if there would be 

an inclination to write 2 years into the limitation, that would certainly be all right with the Department.

Air. Williams. I believe tha t is all, Air. Chairman.

The Chairman. Air. Springer?

Air. Springer. I do want to welcome my old friend and next-door 

neighbor when he was in (he House to another job in Washington.

Air. Commissioner, last year when we had this matter up, and I do 

not know tha t it was anybody’s fau lt—it may have been lack of personnel 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 your Department to get adjudication once a petition 

had been filed. If you would turn to page 2 of your statement, you 

will notice the words: “We have received 319 petitions for food a dditive regulations.”

No, turn to the fourth item: “59 led to the issuance of regulations 

stating safe conditions for using the addil ves involved.”
FOOD ADDITIVES 17

Would you please tell the committee approximately how many 

weeks or months or days there were from the time a petition was filed 

until there was an adjudication? What was the average length?

Mr. Larrick. Mr. Springer, tha t varies tremendously. Bear in 

mind that these petitions ordinarily are concerned with chemistry, 

they are concerned with pharmacology, and they are concerned with 

medicine; and routinely, if it truly is a new chemical, it has to go 

through all of our different divisions and they all have to give it very 

careful study, and sometimes these petitions will be 6 inches thick.

I would say tha t at the beginning it took us about 3 months to han ­

dle each petition.

Mr. Springer. In other words, this is an average of about 90 days; is 

that correct ?

Mr. L arrick. Th at is an approximation, but as we gain experience 

and as industry gains experience in knowing w hat our scientists want 

in the petition, the timelag is getting progressively less.

In other words, we are learning and industry is learning.

Air. Springer. Do you ultimately hope you can decide these in half 

that time ?

Air. Larrick. Some of them. Very often, we have to send them 

back and say, “You do not have enough animal testing.”

Mr. Springer. Are you finding any broad objection in the industry 

as to the length of time involved in getting adjudication ?

Mr. Larrick. I would say that any Government agency always finds 

objections of people who want to get their problem solved immediately; 

but, no, I would say in general we are getting along very nicely with 

industry.

Air. Springer. That 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. Roberts. Air. Chairman, I would like to join one of our colleagues, Air. AVilliams, in welcoming our former colleague, Air. Secretary, to our committee. I am sure there will be many other appea rances by the Secretary and he can always find a warm welcome here 

in this committee.

Just one or two questions, Air. Larrick. In your statement, at page 

2 ,1 notice that you have 178 petitions now being actively evaluated.

Air. Larrick. Yes, sir.

Air. Roberts. Could you give us any estimate of how much more 

time you think might be required to finish those 178 cases?

Air. Larrick. To finish all of them, Air. Roberts, will unquestionably take 3 to 4 months, but 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 rat or they will say they are incomplete because of the chemistry, but 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 though you did not extend the Alarch 5 deadline, 

we would not take any action on tha t article in a legal way until afte r 

we had given the man our appraisal of the safety of his product. Once
18 FOOD ADDITIVES

he has filed his petition and put it in, we do not take any action until 

we have handled th at ma tter and decided it one way or the other.

Mr. Egberts. However, it is your view tha t the 3-year extension 

would suit your purposes better than the 2 years ?

Mr. Larrick. Yes, sir.

Mr. Roberts. Tha t is all I have, Mr. Chairman.

The Chairman. Mr. Younger?

Mr. Younger. Mr. Larrick, 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 situation with a new Congress, and we are meeting on February 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. Younger. It seems to me tha t the new Congress in 1963 may be 

up against the same kind of an operation tha t wTe have this year.

Mr. L arrick. I think you have a very fine point.

Mr. Younger. So, 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 expiration. I certainly would recommend 

tha t the extension be made, rather than March, up until May or June. 

Do you agree with that ?

Mr. Larrick. Yes, I do, Mr. Younger.

Mr. Younger. Thank you. That is all, Mr. Chairman.

The Chairman. Mr. Moulder ?

Mr. Moulder. No questions.

The Chairman. Mr. Avery ?

Air. Avery. Thank 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 forward to 

serving with you in the legislative and administrative relationship.

Air. Larrick, of course, we consider a standing consultant of this 

committee.

Air. Larrick. Thank you, Air. Avery, I always have a good time 

up here.

Air. Avert. I just have one question and this should be directed 

to you, Air. Larrick. I think it is pretty clear about the status of 

the 3,000 chemicals th at are presently listed as food additives. I am 

not so clear about the chemicals that 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 just a little in his opening remarks. 

As I understand the bill, there is no provision for an extension of time 

in regard to those possible suspect chemicals at all. If they subsequently should be listed as food additives immediately they would 

either have to suspend their use or have it terminate to the satisfaction 

of yourself, tha t there were no cancer-producing elements in them.

Air. Larrick. Yon are quite righ t, Air. Avery.

Air. Avery. As I read the bill, there is no provision in there. You 

suggested one amendment that you were going to offer and as I heard 

you tha t would only apply to a chemical that is presently pending on 

the date of the expiration of the time limit in the present statutes.

Air. Larrick. You are quite right.
FOOD ADD ITIVES 19

Mr. Avert. However , you are no t sugg estin g any lan guage th at 

wou ld give any co nside rat ion to those che micals th at m igh t so be desig ­

na ted as suspect a dd itive s sub sequen tly ?

Mr. I jarrick. I t hi nk th at whole prob lem is too speculative to deal 

with. I do not an tic ipate th at so rt of s itu atio n arising , ce rta inly no t 

very oft en in the fu ture, and I wou ld ha te to see the bill com ple tely 

open-ended foreve r. I t is conceivable th at with res pec t to some can 

lin ing o r some p ac ka ging materia l w hich we now do not th in k g ets in to 

the food, it m ight be p ossible th at 10 years fro m now, we would find 

th at the food does absorb it, bu t then I th in k we wou ld have to dea l 

wi th th at as it comes up.

I really do not th ink, M r. Av ery , th at there is enou gh pr ob ab ility o f 

th at problem arising.

Mr. Avery. Th en yo u would oppo se lan gu ag e th at would giv e consid era tio n to such chemi cals ?

Mr. L arrick. No, I w ould not say I w ould oppose it. I w ould h ave 

to see it. I th ink it is i mp era tiv e th at we ge t th is bill t hrou gh , because 

if we do no t ge t it th roug h by M arc h 6, th ere is go ing to be chao s in the 

food indu str y an d the n, Mr. Av ery , if we do find t hat there are some 

bug s in it, we w ill be the first ones to come up here an d try to recommend wh at is th e f air thi ng to do.

Mr. A very. I do not w an t to bela bor th is po int, b ut if the committee, 

in its jud gm ent, would elect to includ e such lan gu age your dep ar tment, if the lan guage was in good stea d, would no t oppose it?

Mr. L arrick. No.

Mr. Avery. Th an k you , Mr. C hairm an.

Th e Chairma n. Mr. Fr ied el ?

Mr. F riedel. I h ave no qu estions, b ut I w an t to say th at I am glad 

to hav e you, Mr. Ribicoff, as Se creta ry of Hea lth , Ed ucati on, and 

Welf are . I did n ot have the p lea sure o f s erving w ith you. I came in 

ju st after you le ft, but I i nte nd to keep in close tou ch w ith you. T hat 

is all, Mr. C hairm an.

Th e C hairman. Mr. Collier?

Mr. Collier. Mr. La rri ck , ju st to pu rsu e very briefly the lin e of 

quest ion ing of M r. Sp ring er and Mr. Rober ts, did I un derst and you 

to say t hat wi thin 3 to 4 months, you an tic ipated clea rin g the 178 t hat 

ap pe ar on the l ist o f those p eti tio ns t hat are act ive ly being evalu ate d ?

Mr. Larrick. I w ould say th at fo r the mo st par t, we wou ld be able 

to d ispose of them one way or an othe r wi thin abou t 3 m onths. I do 

no t want to be held to t hat to the d ot because I have no t looked a t the 

de tai ls of all o f them.

Mr. Collier. I u nd erstan d t ha t. This, however , would exclude any 

of those then th at are being tested fo r chron ic tox icity inasmuch as 

yo ur statement says it w ould ta ke up to 3 ye ars ?

Mr. L arrick. All of these, sir, hav e h ad th at wo rk done. We do no t 

do the work. Th e law require d th at the m an uf ac tu rer sub mit to us 

a com plete pro tocol which will includ e the chem istry, the ph ar m acology, the med icine, and everything else involved, and pre suma bly 

the se 178 have all h ad t hat w ork done, so th ey h ave alr eady used th ei r 

to 3 ye ars.

Mr. Collier. I s it no t true, however , th at th ere have been instances 

wh ere th e m an uf ac turer has mad e his submis sion of t hi s inform ation 

an d the re has been a f urt her delay in the d ep ar tm en t in clea ranc e ?
20 FOOD ADDITIVES

Mr. Larrick. You have to review th is material with great care and 

there are a great many of them to be considered.

As we say, there are some thousands th at we have given extensions 

to and we have had to determine tha t there was no undue hazard to the 

public health, so very obviously, during this transition period, there 

have been delays.

Mr. Collier. I point that out only to establish from my own reasoning the need for more tha n 2 years then in this extension.

Mr. Larrick. I will be content to abide by the judgment of this 

comimttee about the length of time, but I am very certain tha t if 

we just get 2 years, we will be back asking for more time.

Mr. Collier. That is all, Mr. Chairman.

The Chairman. Mr. Macdonald?

Mr. Macdonald. Than k you, Mr. Chairman.

I do not have any questions. I would like to join with my colleagues 

in welcoming Governor Ribicoff as our new Secretary of Health, E ducation, and Welfare. I am sure this is just the beginning of a very 

harmonious period of time for both of us.

Than k you, Mr. Chairman.

The Chairman. Mr. Devine?

Mr. Devine. No questions, Mr. Chairman.

The Chairman. Mr. Ja rma n?

Mr. J arman. No questions.

The Chairman. Mr. O’Brien ?

Mr. O’Brien. No questions, Mr. Chairman.

The Chairman. Mr. Keith?

Mr. Keith. I would like to join with my colleagues in welcoming 

this new Secretary. I am very pleased tha t he has had experience 

in the Congress and is therefore, close to our problems with our constituents, the consumers, and the producers. I would like, just for 

the record, to remind him of the very serious problems th at atfect an 

industry in the process of determining what is a carcinogen. This 

gets to the root of this whole question.

In the case of the cranberry incident of a year ago, when we had 

tha t before the Congress, the problem was caused, not by the administration of the law by your office, but by the definition of what was a 

carcinogen, and what could cause cancer in a human being. The 

fundamental question really is, Wha t is a carcinogen and what constitutes a significant amount of a carcinogen? And I think there should 

be an effort to bring into the legislation the opportunity for the 

Secretary of HEW to use reason and judgment. It does not now 

exist in the present law.

Thank you, Mr. Chairman.

The Chairman. Mr. Moss ?

Mr. Moss. I have one question, Mr. Chairman.

Mr. Larrick, you indicated that the 2-year suggestion by Mr. Delaney would be inadequate and stated a preference for a 3-year period. 

What is your best judgment as to a realistic period for extending this 

in order to permit you to accomplish all of the necessary testing now 

foreseeable ?

Mr. Larrick. We are going throu gh a period of major readjustment in our food supply and I do not think anyone can honestly tell 

you with certainty how long it is going to take to get over this hump,
FOOD ADD ITIVES 21

but I am quite content to have 3 years if we could have it, or 2 years, 

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 judgment now as to the appropriate extension ?

Mr. Larrick. I think 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 Secretary for coming up here. 

I had an opportunity to meet with him earlier and I had an opportunity 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 Chair, I would like to treat two things 

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 regarded as an additive, on 

evidences found by the Food and Drug, or by independent researchers to show that this happens to be in effect an additive, or a previously 

harmless substance now shows that it might perhaps be harmful.

Is it not a fact that there is, without this particular legislation, 

adequate authority for the Food and Drug Administration to require 

analysis, examination, and studies to be made which would be appropriate to protect the public interest in those instances ?

Air. Larrick. Quite righ t, sir.

Mr. Dingell. And this bill does not tre at with that at all ?

Mr. Larrick. No.

Air. Dingell. And there is no reason why it should ?

Ah’. Larrick. I do not think it needs to be treated.

Mr. Dingell. We have been talking about time limits on this. As 

you perhaps 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 to infer 

that you would not be able to accomplish the great bulk of the work 

tha t is imposed upon you by the law right now ?

Air. Larrick. No. Three years would take care of the great bulk 

of it, Air. Dingell.

Air. Dingell. 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. Larrick. For all practical purposes, yes.

There may be a few left over that we would not have the answer 

to in 4 years, but certainly the great bulk of them ought to be disposed of.

Air. Dingell. The reason I talk about 4 yeai's is that 3 years is 

enough for a good dog test, is that not right? "

6 6 7 3 8 - 61------4
22 FOOD ADDITIVES

Mr. Larrick. Yes. I think Mr. Younger has a very good point 

when lie says that, it ought not to expire right at the beginning of a 

new Congress, and make an emergency if we do have to come back up.

Mr. Dingell. For this reason, you would suggest 3 instead of 4, so 

we could look at it more carefully?

Mr. Larrick. 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, put it back, say to June, would this lie better still ?

Mr. Larrick. Yes, much.

Mr. Dinoell. Thank you, sir.

Thank you, Mr. Chainnan.

The C hairman. Mr. Sibal ?

Mr. S ibal. Mr. Chairman, I have no questions, but I would like to 

take this opportunity to state how happy I am tha t circumstance has permitted my path to cross with Secretary Ribicoff again. 1 am 

afraid it will take me a while to learn to call him Secretary and not 

Governor.

The Chairman. Mr. Rogers?

Mr. Rogers of Florida. Mr. Chairman, just a question or two.

Of course, I want to join in greeting the Secretary and his distinguished stall' here, and we are particularly pleased to see Mr. Lar­ 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 authority for you to inquire 

into products, I happen to have a m atter that I took up with the Departm ent in Jan uary concerning, and I will not identify it, a cosmetic application. The people who had bought the product were concerned 

because it had no clearance on its labeling from Food and Drug, and 

so forth, and so they wrote to see if there were some way they could find whether this application would be safe to use before they actually used it. The reply I received back from the Department of Health, Education, and Welfare was that, first of all—

The Federal Food, Drug and Cosmetic Act applies to the safety of the product and its labeling. No prio r clearance is required by law. We have received 

no com plaints of adverse reactions from its use.

And you had none and they gave no adverse reaction because they 

had not yet used it. This next sentence is what concerns me:

Inform atio n as to composition has been refused by the manufac tur er and since we have not found significant claim s in the labeling we have not had occasion 

to analyze the product.

Wh at I want to know is, Do you have necessary authority when a 

request is made like this to determine whether the products in a cosmetic application are safe enough? Do you have authority to ask the 

manufacturer to at least let you know what is in th at product, or not ?

Mr. Larrick. 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 are planning with the consent of the Secretary, to send up to this 

committee durin g this Congress, broad authority to do factory inspection and to get just that information.
FOOD ADDITIVES 23

Air. Rogers of Florida. Is this a normal practice for m anufacturers 

to refuse to give you such information?

Mr. Larrick. No. I would say that the grea t bulk of the manufacturers, in spite of the fact that there is no compulsion to give it to us, except in certain instances, do give it to us voluntarily, but 1 think 

tha t the Government should have the power to require that sort of information in protecting the public health.

Mr. Rogers of Florida. 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 manufacturers who are reputable never object to cooperating and those that are questionable usually do, and the questionable ones are those that raise the problems for the con­ sumer and for the constituents who want to make sure they are doing 

the right thing. Wo are going to send up legislation and we would hope that this committee would give it their most favorable consideration. It is 

something that the Department has taken up with me.

Mr. Rogers of Florida. That is tine. Thank you.

The Chairman. Mr. Hemphill ?

Mr. IIempiiill. I have one question of Mr. Larrick. If this committee saw fit to put a time limitation 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 that accomplish it?

Mr. Larrick. I believe it would, sir.

Mr. IIempiiill. Thank you very much.

The Chairman. Mr. Rostenkowski ?

Mr. Rostenkowski. I have no questions, Mr. Chairman.

The Chairman. Mr. Roberts?

Mr. Roberts. With reference to the suggestion you made, Mr. L ar­ rick, for adding additional language afte r line 3, page 2, and page 3, line 8, I would like you to elaborate on what you consider meets the 

test of bona fides on the part of the industry ?

Mr. Larrick. If the industry 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 it—something went wrong with the test, or it took more time than they thought was required—1 would 

think tha t that would pass the test- Also, in the case of some additives a literature search is a tremen­ dously involved and time-consuming m atter, and if they could show tha t they diligently tried to search the literature of the world, to see whether or not this chemical is either safe, or generally recognized as safe, or proven safe by previous tests, I would be inclined to let them 

have the advantage of the extension.

Mr. Roberts. Suppose you have an additive that has generally been considered to lie safe. Then in the light of new scientific knowledge, it moves into the suspect area. What kind of a test would you apply 

to that particular industry ?

Mr. Larrick. 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 injury to the public health, I would stop its use until they had done whatever amount of testing 

is necessary to clear it.
24 FOOD ADDITIVES

I would resolve the question in favor of the public health. I do not 

think that will happen very often.

The Chairman. Mr. Keith?

Mr. Keitii. Mr. Larrick, you mentioned that if a partic ular chemical became suspect, you would recognize t hat factor in your administrative course of action. What about the chemical which by use gradually is found to not be a carcinogen ? What action do you take to 

look out for the consumer and industry protection there?

Mr. L arrick. Mr. Keith, I would say that in all the administration 

of this act, and all other acts perhaps, we should employ the rule of 

reason and resolve the quest ion in favor of the public health, but not 

conjure up artificial suspicions to do harm to the industry.

Mr. K eith. To the liest of your knowledge, has there been any reason to believe or suspect tha t any cancer has been induced by the consumption of cranberries at any time ?

Mr. L arrick. We produced a cancer of the thyroid in animals, but 

I do not have any evidence that it produces cancer in man. I want to 

forget about the cranberries now.

Mr. Keith. I would like to correct your testimony. It, was not 

cranberries tha t caused the cancer.

Mr. Larrick. That is right. You are right.

Mr. Keith. I do not believe that your research will ever reveal that 

cranberries were a vehicle for amino to the extent tha t any cancer 

resulted, anyway.

Mr. Larrick. Mr. Keith, we gave cranberries a clean bill of health.

Mr. Keith. Costing nevertheless, the industry a tremendous amount 

of money.

Thank you, Mr. Chairman.

The C hairman. While you are on that subject, I am constrained to 

inquire if you gave chickens a clean bill of health.

Mr. Larrick. We sure did.

The C hairman. Mr. Secretary, you mentioned it in your statement, 

but I think it would be appropriate to emphasize the fact that this 

bill extends your authority to certain food additives and certain 

pesticide chemicals. I am somewhat of the opinion tha t most people 

feel that this bill relates only to food additives. I wanted to emphasize 

just what it does.

Section 2 of this bill, II.I\. 3980, has to do with the extension of 

this authority as far as it is applicable to food additives, is that 

not true?

Mr. L arrick. That is correct, sir.

The Chairman. And section 3 so far as its application is concerned, 

would be to pesticide chemicals?

Mr. Larrick. Let me explain that if J may.

The Chairman. All right.

Mr. Larrick. 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 agricultural chemical people preferred to have all of the articles 

of this type that are used in agricu lture handled under the pesticide 

bill, rather than having part of them under pesticides and part of 

them under food additives, so they went to the Agriculture Committee
FOOD ADD ITIVES 25

with whom the y norm ally do business, an d the y got these substan ces 

th at are listed there at the top of page 3 dec lare d to be pesticid e 

chemicals.

Th ere is no lon ger au th or ity fo r defer me nts under the pesticid e 

bill. We t ho ug ht it only fa ir to give th em the same o pp ortunitie s fo r 

defer me nt the y would have received if the y ha d rem ained foo d ad di ­

tives.

The Chairm an. I thou gh t hat th at sho uld be clea red up or un de rstood. Tind er the pro vision s of the bill, the Se cretary could gra nt an 

extension of tim e if he finds th at (1) there is a bon a fide action to 

det erm ine the ap plicab ili ty of th e food ad ditiv e law to a pa rtic ul ar 

subs tanc e th at was comm enced before Marc h 6, 1960, and was thereaf te r pursu ed w ith rea son able dilige nce; (2) an d he had ad ditio na lly 

gr an ted an extension to Ma rch 5, 1961; an d (3) a fu rther extension 

of tim e is necessary to com plete scientific inv estiga tions. Those are 

the lim ita tio ns on yo ur Dep artm en t with refere nce to this pro posal ?

Mr. L arrick. Ex actly .

Th e Chairm an. W ha t wou ld happen, as Mr. Roberts mentio ned a 

mom ent ago, if there was a substan ce th at ha d no t been con sidered 

to bo a food ad dit ive and yet, by some development or because o f someth in g th at m ight h ap pe n, it was sud den ly determined th at this was a 

food additive ? W ha t would hap pen to th at substance?

Mr. Larrick- At th at stage, Mr. Ch air man, it would become the 

Responsibility of both the m an uf ac turer and th e Gov ernment to tak e 

a look at the qu estion o f wh eth er or n ot in the am ount th at th is p ro duct appear s in the food it is safe or harmful.

I f a conclusion could be re ach ed th at it is safe, the n no thing would 

happen. I f a conclus ion was reached th at it was ha rm fu l, it wou ld 

have to get o ut o f th e food su pply.

Th e Chairma n. Would there be any tim e to det erm ine w hethe r or 

no t it was safe o r harm fu l ?

Mr. Larrick. Th ere wou ld be no tim e if it was definitely show n 

to be h arm ful.

Th e Chairman. O f course, if it was definitely shown to be h armfu l 

you would not need any time.

Mr. L arrick. T hat is right.

I f it was unk now n, the n we would have to giv e time to find out 

whi ch is rig ht.

Th e Chairman. Cou ld you give tim e un de r this provision?

Mr. Larrick. I think th at we wou ld have th e ad minist rativ e au ­

th or ity to be reason able in the m atter.

Th e Chairm an. Mr. Se cre tar y, may I than k you and Mr. Lar rick 

fo r yo ur ap pe aring here this morning and yo ur testimon y. We ap ­

pre cia te yo ur br inging wi th you yo ur staff an d pre sen ting each of 

the m to the members of th is comm ittee.

Secre tary Ribicoff. Tha nk you very much fo r the cou rtes y of 

yoursel f and the com mittee, and we will look fo rw ard to bei ng here 

fre quently in th e ma ny mo nth s ahead.

Th e Chairma n. Th an k you.

Mr. L arrick. An d I enjo yed myself.
26 FOOD ADDITIVES

The Chairman. Thank you. We are glad to have you back, Mr. 

Commissioner. We look forward to seeing you here again, too.

We have two witnesses from out of town. Mr. Boyd, I observe that 

you are from New York. We are going to hear you right now.

STATEMENT OF GEORGE BOYD, JR ., COUNSEL, AMERICAN PA PE R 

& PULP ASSOCIATION, NE W YORK, N.Y.

Mr. Boyd. Mr. Chairman and members of the committee, my name 

is George Boyd, Jr. I am a member of the law firm of Dunnington, 

Bartliolow & Miller, in New York City. We are counsel for the 

American Paper & Pulp Association, the overall national association 

for the paper and pulp industry, with which I believe all of you gentlemen are thoroughly familiar. I think you have before you the 

statement which we have prepared on behalf of the American Paper 

& Pulp Association, the first page of which sets forth briefly the 

thoughts of the pulp and paper industry concerning H.R. 3980.

Appended to this is a more detailed explanation of our proposed 

amendment to the bill. Gentlemen, may I make it perfectly clear that 

the pulp and paper industry supports H.R. 3980. The one point that 

I would respectfully make to the Committee on Interstate and Fo reign Commerce is tha t in the letter transmitting the proposed bill 

to the committee, and to the Speaker of the House, and the President 

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 understanding tha t Secretary Ribicoff. 

the able Secretary of Health, Education, and Welfare, has endorsed 

the request by the former Secretary.

The question has been raised before the committee this morning as 

to what would happen in the case of substances which presently are 

generally recognized as safe or substances which the Food and Drug 

Administration has prior sanctioned, both of which categories under 

the food additives amendment are exempt. The fact of the matter is, 

gentlemen, under H.R. 3980, as it is presently drafted, afte r March 

6, 1961, if a substance would be determined to be other than 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 Drug would not legally have any 

authority to grant an extension of time during which the Food and 

Drug Administration and the affected industry or companies could 

ascertain what tolerances might be required, if any at all.

In other words, absent the provision that we have recommended 

in the attached bill to our statement people would be put in (he position of requesting the Food and Drug Administration to perform an 

act unauthorized by law, and we certainly have had the most friendly 

and cordial, and helpful relationship with the able Food and Drug 

Administration both on the administrative and technical side, and I 

think it undesirable to put any Government agency in a position where 

they may not exercise authority by benefit of law.

I thin k this pretty much covers, Mr. Chairman and gentlemen, the 

views which I have to express on behalf of the industry, except that 

I would like to state that as far as paper and paperboard for food 

packaging purposes are concerned, they have been used for 60 years
FOOD ADDITIVES 27

and there is no case of record where there has ever been any illness caused by any migration or tra nsfer, and in the opinion of competent scientists, paper and board for food packaging purposes are not food 

additives as defined in the law. If Mr. Muldoon could have his 25 seconds, Mr. Harris, I would be 

most grateful, sir.

(Mr. Boyd’s statement follows:)

Statement of American Paper & P ulp Association

The former Secretary of HEW, in a letter to Speaker Rayburn, urgently re­ quested the enactment of a hill to remove the time limitations for discretion ary extensions under the food additives law, so that FDA and affected industries will have more time to determ ine, among other things, “whether th at law applies to the substanc es involved at all.” Secretary Ribicoff has fully endorsed this request. Affected industries agree with the Secretary th at it is essential to provide additional time to determine the applicability of the law to a particular substance. The bill submitted, now H.R. 3980, does not accomplish this. II.R. 3980 un­ necessarily limits the Secreta ry's autho rity to grant extensions to situations 

where prior extensions have been given. There are a gre at many substances now “generally recognized as safe” or that have received prio r sanctions for use. If in the future the s tat us of these substances should change for any reason (and this has occurred in the pa st), additional time would lie required by FDA and affected industries to develop scientific data for a required regulation. Under II.R. 3980 the Secretary would be powerless to grant such additional time after March 0, 1901. It is extre mely imp orta nt that this deficiency lie corrected. A bill to accomplish this, toge ther 

with a more detailed expla nation, is attached.

A Substitute Bill for H.R. 3980, the Proposed Food Additives Transitional

Provisions Amendment of 1901

A draft bill entitle d “Food Additives Tra nsitional Provisions Amendment of 1901,” together with accompanying letter and exp lanatory material, was tran s­ mitted to the Speaker of the House of Representatives on Jan uary 13, 1901, by the former Secretary of Health, Education, and Welfare. The draft bill was introduced as requested, and is now before the Committee on Interst ate and Foreign Commerce as H.R. 3980. The basic concept of this proposed legislation is the removal o f the time limit of March 0, 1901, which now exists with respect to a food additive in commercial use before Janu ary 1, 1958. The autho rity of the Secretary of Hea lth, Education, and Welfare to postpone the effective date of the Food Additives Amendment of 1958 for such food additives und er the proposed legislation, and under the present law, can only be exercised when there is no undue risk to the public health and conditions exist necessitating 

the prescribing of an additional period. As indicated in the letter of tra nsmi tta l to Speaker Rayburn, legislation to extend the discretionary jieriod for the Secretary to grant extensions is requ ired both by the Food and Drug Adm inistration and by affected industries because the Food and Drug Adm inistration cann ot physically process petitions und er the food additives amendment before March G, 1961—the present cutoff date on the a uth ority of the Secretary to gra nt extensions—and because affected in­ dustrie s cannot possibly develop all necessary scientific data, information and 

petitions before that d ate. H.R. 3980 does not fully meet the needs of the p resent situation. As pointed out in the former Sec retary ’s letter, the additional autho rity conferred by the hill is not only necessary in order to perm it the completion of inquiries or stud ies to determine the safe use of an additive und er the food additives amendment, but also to permit necessary time in which an interested party might deter mine “whether tha t law applies to the substance involved a t all.” The language in section 2 of H.R. 3980 is unnecessarily restric tive on the dis­ cretion of the Secre tary. It is inconsistent with one of the stated purposes of the bill in that it would res trict his autho rity to gr an t necessary and desirab le exten sions only to those substances which were food a dditives in commercial use
28 FOOD ADDITIVES

before Janu ary 1, 1958, and then only if an extension had been gra nted prio r 

to March 6, 1961.

It is a known fac t th at there are many substances which are now generally 

recognized as safe by qualified scientific exp erts and which are consequently not 

food additives within the meaning of the Food Additives Amendment of 1958. 

It is entirely possible th at some of these at some fut ure time will no longer be 

so recognized. In such event, time will be requ ired for the promulgation of an 

appropriate regulation governing the conditions und er which the food additives 

may be used. It seems only fa ir th at so long as the Secretary finds there is no 

undue risk to the public hea lth he should be perm itted to grant such time. The 

Secretary und er the present language of II.It. 3980 would be i>owerless to gra nt 

such add itional time.

This is ju st one area in which problem s would be created by the present 

section 2 of the bill. The same argument would apply equally to substances 

which were sanctioned by the Food and Drug /Administration prior to enactment of the food additives amendment on September 6, 1958. Such sanctioned 

items are presently exempt under the law. However, if any of such sanctions 

were to be with draw n, the user would be in the position of having a food additive in violation of law, withou t recourse to the extension procedure.

Therefore, section 2 of H.It. 3980 should be amended to e nlarge the discretion 

of the Secreta ry to gra nt extensions not only with respect to food additives commercially used before Janu ary 1, 1958, but also with respect to substanc es now 

considered exempt under the law, but which at some futur e date may be considered a food add itive requ iring appro priate regulations prescribing conditions 

under which they may be safely used.

In summary, the Secreta ry’s autho rity to gr an t extensions should encompass 

not only substances now known to be food additives but also those substances 

for which additional time may be requ ired to determ ine the applicab ility of the 

law. A bill to accomplish this is submitted herewith .

A BIL L To am en d th e tr an si ti o n al pr ov isio ns of th e A ct ap pr ov ed Se pt em be r 6, 1958, 

en ti tl ed “A n Ac t to pro te ct th e pu blic hea lt h by am en di ng th e Fed er al Fo od , Drug, an d 

Co sm eti c A ct to pro hib it th e use in food of ad dit iv es wh ich ha ve not bee n ad eq ua te ly 

te sted to es ta blish th eir sa fe ty ,’’ an d fo r oth er pu rp os es .

Be i t enacted by the Senate and House of Representatives of the United States

of America in Congress assembled, Th at th is Act may be cited as the “Food 

Additives Trans itio nal Provisions Amendment of 1961.”

Sec. 2. Subsection (c) of section 6 of the Food Additives Amendment of 1958 

(Public Law 85-929, 72 Stat. 1784, 1788) is amended (i) by deleting the words 

“if such use was made of such add itiv e before J an ua ry 1, 1958” and substitutin g 

therefor the words “if the substances making up such additive were similarly 

used before Janu ary 1, 1958,” and (ii) by inserting in such subsection, at the 

end thereof, the following : “Notwithstanding th e parenth etical time limitation in 

clause (1) (B) of this subsection, the Secreta ry may extend such effective date 

under the autho rity of that clause (bu t subject to clause (2 )) with respe ct to 

such use (or a more limited specified use or uses thereof) if, in addition to 

making the findings required by clause (1) (B) he finds t ha t bona fide a ction to 

determin e the applicability or inapplicability of such section 409 to such use or 

uses, or to develop the scientific data necessary for action under such section, 

was commenced by an inte rested person and is being pursued with reasonable 

diligence. The Secretary may at any time terminate an extension so g ran ted if 

he finds th at it should not have lieen granted or that by reason of a change in 

circumstances the basis for such extension no longer exists, or th at the re has 

been a failu re to comply with a requirem ent for submission of progress reports 

or with oth er conditions attach ed to such extension.”

Sec. 3. Pa ragrap h (b) of section 3 of the Nematocide, Plant Regulato r, Defoliant, and Desiccant Amendment of 1959 (Pub lic Law 86-139, 73 Stat. 286, 

288) is amended by inserting in such par agr aph , at the end thereof, the following: “Whenever the Secretary of Hea lth, Education, and Welfare has, pursuant 

to clause (1) of this parag rap h (b), prescribed an additional period expiring on 

March 5, 1961, with respe ct to any such pa rticular use of a nematocide, pla nt 

regulator, defoliant, or desiccant, he may, notwithstanding the provision to 

the con trary in such clause (1), furth er exten d the expiration date applicable 

under such clause (1), (bu t subject to clau se (2 )) with respect to such use of 

such substance (or a more lim ited specified use or uses thereo f), if, in addition to 

making the findings requ ired by clause (1), he finds (A) that bona fide action 

to determine the applicability of such section 408 to such use or uses, or to
FOOD ADDITIVES 29

develop the scientific data necessary for action under such section, was commenced by an interested person before March 6, 1960, and was ther eafter pursued with reasonable diligence, and (B) tha t in the Secretary’s judgment such extension is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary as a 

basis for action under such section 408. The Secretary may a t any time terminate an extension so granted if he finds tha t it should not have been granted, or 

that by reason of a change in circumstances the basis for such extension no 

longer exists, or that there has been a failu re to comply with a requirement for submission of progress reports or with other conditions attached to such 

extension.”

The Chairman. You may identify yourself.

STATEMENT OF THOMAS J. MULDOON, TECHNIC AL DIRECTOR, 

NATIO NAL PAP ERB OARD ASSOCIATION

Mr. Muldoon. Yes, sir. My name is Thomas J. Muldoon and I 

am the technical director of the National Paperboard Association. 

The National Paperboard Association concurs with the American 

Pap er & Pulp Association in its feeling tha t the Food and Drug A dministration should have the necessary power to gran t extensions, 

especially in situations where a material 'which is now not, that is, 

before next week’s extension, considered to be a food additive or 

subsequently held to be one. This material, as well as the materials 

now on extension, would need a time extension in which to prove its 

safety.

I understand there are presently 700 materials which are generally 

recognized as safe and also a very large number of materials being 

used under prior sanctions, and we feel that provision should be made 

to cover the contingency that one of these materials is removed from 

its current status.

Thank you.

The Chairman. Mr. Boyd, when I asked Commissioner Larrick 

the question as to what would happen, I understood his response to 

be th at if such a condition were to arise, he thought under this bill, 

or under the existing law, the Food and Drug Administration would 

have regulatory authority to deal with the subject. You say that they 

would not under this bill.

Mr. Boyd. Mr. Chairman, I would say under this bill, much as I 

respect the able Commissioner, th at it would be an extralegal act by 

the Food and Drug Administration to grant an extension af ter March 

6,1961, to a substance which had not previously 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 thought I asked Mr. Larrick essentially the same question as you 

did and got a different answer. I understood Mr. Larrick in response 

to my question to say he had no autho rity to gran t an extension of time 

for testing, if it became suspect and then in response to you, he said 

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. Larrick. I did not think I was doing any doubletalk.

The Chairman. I am sure it was not intended, if you did.

Mr. Avery. I did not mean to so infer, but I was confused.
30 FOOD ADDITIVES

Mr. Larrick. No. If an article were found to contaminate food 

and it were shown that the article is harmful to human beings, or is 

highly suspect—I mean highly suspect so that you can’t determine 

whether it is going to do harm —I think then i t would be our obligation to take it out of the food.

On the other hand, under the circumstances that Chairman Harris 

referred to, where you suddenly discover tha t an article tha t you 

thought did not migrate into a food and you had no facts 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 think that, 

as Commissioner of Food and Drug, I have the administrative right 

to do the fai r thing and permit time to elapse to test it.

Have I cleared up my answer ?

The Chairman. You have in my mind, so fa r as your own position 

is concerned, but let me ask it this way for the record, and I think 

this is important. It is true that there are many substances now 

generally recognized to be safe.

Mr. Larrick. A great many.

The Chairman. There are many substances that have received prior 

sanctions for use.

Mr. Larrick. That is right.

The Chairman. Now, suppose that a substance that has generally 

been recognized as safe, or th at has received prior sanctions from you, 

at some future date becomes suspect. Would you then have authority, 

in your opinion, under the law and the extension under this bill, to 

give time for that suspicion to be resolved ?

Mr. L arrick. Mr. Harris, I think that would depend on the degree 

of suspicion of the article. If it were a grave suspicion, I do not 

think 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. Larrick. That is right, and if we do not know, I think we have 

the authority to let them test it.

The Chairman. If it becomes suspect and a final determination has 

not been made you would have authority then to have them test it?

Air. Larrick. I think so.

Mr. Younger. Mr. Chairman, may I ask a question ?

The Chairman. Yes.

Air. Younger. Mr. Larrick, as long as there is some doubt as to 

whether you have the authority or do not have the authority, do 

you have any objection to clearing this up and making sure tha t you 

do have the autho rity ?

Air. Larrick. I never object to anything that this committee doesThe Chairman. That is a very broad statement.

Air. Larrick. When this committee speaks, we follow. I do not 

think it is necessary, Air. Younger.

Air. AIoulder. You say you have the authority, but under what 

provision of the law do you base your au thority ?

Air. L arrick. I think I have administrative discretion to apply the 

rule of reason to everything th at we do in Food and Drug, and I do 

not think that 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 provision of the law 

which gives you the authority ?
FOOD ADDITIVES 31

Mr. Larrick. No.

The Chairman. Could you supply that ?

Mr. L arrick. We could supply you some Supreme Court decisions 

that say that an administrator of a Federal law is supposed to use commonsense and apply the rule of reason. That is about as far as 

we could go.

The Chairman. Mr. Boyd, does that satisfy you ?

Mr. Moss. Would you yield at tha t point, Mr. Younger?

Mr. Younger. I do not have the floor.

Mr. Moss. Mr. Chairman?

The Chairman. Mr. Moss. Mr. Moss. I have been trying to figure out just what we would be discussing by inference here if it is not now regarded as an additive or as an addition of any type potentially dangerous, and at some sub­ sequent date it would become so regarded. There would have to be something occur upon which you would base the conclusion t ha t it would even require examination, and I assume th at you would have to have other than just a suspicion. You would have to have some 

medical evidence before you ?

Mr. Larrick. That is right. 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 and to cover that it would be difficult to draft language, would it not, unless we gave you blanket authority in perpetuity to gra nt extensions for

any reason ?

Mr. Larrick. I have great respect for this great industry that is 

represented here today, but they have not had experience with the administration of the pure food and drug law. It is new to them. Mr. Moss. It seems to me t hat is as far as we can go on at this 

point.

Mr. L arrick. I think they are worried about something th at is 

not likely to happen. Mr. Moss. In reading the language here which was proposed by the witness who just left the stand, I am intrigued with the change in verbiage in section 2 proposing tha t we delete the words “if such use was made of such additive before Jam iary 1, 1958,” and substituting “if the substances making up such additive were similarly used.” They could be similarly used, but in an entirely different combination, could they not?

Air. Larrick. That is right. Air. AIoss. In this day and age where we do some very interesting things in remaking from the same substances different products, the rearrangement of the substances might produce an entirely different type and potentially very lethal product; yet we would be going into 

an indefinite period of extension. 7

Air. Larrick. That is right. Air. AIoss. It is rather interesting language in that it Opfcns a very 

broad door here.

Air. Larrick. Yes, I think you are quite rig ht

Ah*. AIoss. Tha t is all I have.

Air. Collier. Air. Chairman.

The Chairman. Air. Collier.
32 FOOD ADDITIVES

Mr. Collier. To pursue that a little further, let us take a hypothetical case of a product now being wrapped in, say, a chemically coated 

paper. Let us say righ t now, there is no problem. Let us say that 

a year from now, however, the product fell under suspicion, because of 

something in the coating of the paper.

Under tha t law, if I interpret it correctly, the department would 

have no authority or jurisdiction at tha t point.

Mr. Larrick. Not unless we have had some real, substantial evidence to show tha t it is not recognized by appropriately qualified 

experts as safe.

Mr. Collier. But such auth ority is not provided in this legislation?

Mr. Larrick. Last year, one of the biggest food companies in this 

country came to us and said that they were planning to make a dry 

product t hat would make a root beer. It would be a dry powder anti 

you would put it in a glass of water and you would have root beer. 

This firm is a prudent firm. I am not going to identify it.

They took this material to their laboratories and they ran tests on 

it and they produced tumors, they thought, in some of the laboratory 

analyses. They brought this evidence to us. We were not content 

to act on that because the tests had not been made in our laboratories 

and they were not long enough to convince us, and we wanted two 

tests, anyway.

We started out with a 2 ^-ye ar study of the principal ingredient of 

root beer and when we got about halfway through this test our scientists saw that on further testing this material might be shown to cause 

cancer, so I called in the principal representatives of the bottling 

industry of this country and we laid before them all of the facts. 

It was not a final judgment that this material was poisonous, but it 

was so highly suspicious th at we thought we should share tha t with 

the industry.

This industry decided tha t they would not use safrole any more, 

safrole being the constituent of root beer in question, and it has been 

used from time immemorial. They prudently found substitutes for 

it and took it out of the root beer and today 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 this without any public clamor and they got it 

out before we concluded our test and we accomplished our objective 

without any legal actions.

When we can do tha t, we prefer to handle it that way. That is the 

way I would handle these very speculative things tha t are involved 

in this m atter th at we are discussing.

Mr. Dingell. Mr. Chairman, I would like to be recognized for a 

few questions.

The Chairman. Mr. Dingell.

Mr. D ingell. Mr. Larrick, I am going to ask the clerk to hand you 

a copy of the testimony of the previous witness, and I would like you 

to—in fact, I will hand you my copy of this—look at the specific language that I outlined and I will read it here for the record. It is 

about the fo urth line down. It s ays:

If th e sub sta nces ma kin g up such ad ditiv e were siiuilftrly use d befor e Ja nuar y 1, 1958.
FOOD ADDITIVES 33

Tha t is a substitute as I read the bill for the words which appear 

just above,

If such use was made of such additive before Janu ary 1, 1958.

What is the difference between those two readings and what is 

sought to be done ?

Mr. Larrick. I have not seen this language before, Mr. Dingell. 

I am going to ask Mr. Harvey to answer that.

Mr. Harvey. 1 would think, Mr. Dingell, that the substances tha t 

make up such additive may have been used before, but the additive 

itself, the substance you are talking about tha t would go into the 

food, may not have been used prior to that time.

In other words, a food additive may be made up of a number of different substances. It may have had wide usage, but not in tha t combination and not in that arrangement.

Mr. Larrick. We want to deal with the article as it was used in the 

food, not some different usage.

Mr. Dingell. Now we are getting down to the real purpose of this 

suggested amendment. What they seek, then, is a combination exemption for combination additives as opposed to single constituents 

elements or single additives?

Mr. Larrick. I would think tha t is right.

Mr. Dingell. In other words, under this bill as I read it, they 

would get a blanket exemption. If one substance was just a p art of 

a whole complex additive, they would get a blanket exemption to 

cover the whole spectrum t hat might be involved in tha t one particu ­

lar additive.

Mr. Larrick. Yes, I think this would perm it the use of different 

combinations of additives tha t had been previously used.

Mr. Dingell. Do you read any other differences in this particular 

draft tha t is submitted to us this morning on this point from the bill 

tha t we are considering?

Mr. Larrick. I think we would have to study this to answer th at 

question.

Mr. Dingell. Would you like to have time to submit for the record of the committee, y our views on this particu lar piece of legislation ?

Mr. Larrick. I hope there will be no controversy about this bill, 

because it is tremendously important 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 industry 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 little bit. It is my understanding 

of the law tha t the duty tha t the law imposes upon an agency like 

yours, particularly under the food additives law, is to act only on 

sound and competent evidence in cases of these sorts, particularly 

dealing with the situations where a substance m ight be regarded as 

being slightly suspicious.

The point I am leading to is just this. As a matter of law, you 

could not knock out a substance as an additive, either a color additive 

or a food additive, if you have a mere suspicion. Is tha t not right?

Mr. Larrick. No. Everything we do is reviewable in the courts
34 FOOD ADD ITIVES

and we have to have substantial evidence before we act or the courts 

will knock us down.

Mr. Dingell. And if you fail to have tha t substantial evidence the 

courts will overrule your action; is that not correct ?

Mr. Larrick. As you know very well, that is true.

Mr. Dingell. Thank you very much.

The Chairman. There is just one further question I wanted to ask 

you, Mr. Larrick.

You mentioned your authority. Would you submit for the record 

at this point two or three citations of the Supreme Court, because I 

do not want to be in the position of dealing with what appears to 

be an unknown quantity here, affected by an unknown authority.

Mr. Larrick. I am going to ask Mr. "Goodrich to help me on tha t 

one.

The Chairman. Mr. Goodrich, I am sure, will be glad to assist in 

doing just that for you.

As I understand, there is no difference between you and what Mr. 

Boyd has presented for his industry, except Mr. Boyd and his industry 

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 

authority knocks it out the window all at one time.

Mr. Larrick. Tha t is right.

The Chairman. I think that is a proper question to raise. You 

think you have authority to deal with that.

Now if we do not get this bill through by March 5, which obviously 

we will not be able to do because it takes a little while fo r these things 

to make their way through the Congress, the fact that there will lie 

a few days delay in enactment of this bill would not in any way cause 

your department to move on any of these pending matters, would it?

Mr. Larrick. I will have to enforce the law as it is written, but if 

the legislation is moving forward in due course, I would not be disposed to speed up the action too fast.

The Chairman. And as you mentioned awhile ago, and as is your 

duty, you would feel that you should lie reasonable about it?

Mr. Larrick. That is right, 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 furthe r comment, or Mr. Muldoon?

Mr. Boyd. May I just respectfully say to the committee and to its 

capable chairman, many thanks for the opportunity to appear before 

you all, and if I just might mention to Mr. Dingell, as far as seeking 

any exemptions, sir, I do want to disabuse him tha t we are requesting 

an exemption. All we want to do, as Mr. Larrick has always made 

perfectly clear, is to confer upon the Secretary and upon Commissioner Larrick the authority when they have made certain requisite 

findings under the law, sir, that extensions might be granted.

In other words, we are not suggesting that the law be open-ended 

and exemptions be conferred. There would be no change as far as 

exemption status under our proposed amendment to IT.R. 3980.

Thank you, sir.

The Chairman. Thank you very much. Mr. Boyd.
FOOD ADDITIV ES 35

Mr. Dingell. Air. Chairman, I would just like to make one remark 

here for the benefit of Mr. Boyd. I have the distinct impression, Air. Boyd, tha t in view of the comments that you have heard from the experts on this subject, that if 

you are not starting at shadows, you are seeking to shoot a very large 

hole or a series of very large holes into the law as it deals now with 

food additives.

Air. Boyd. May I say to the able Representatives, that on January 

31 in the Federal Register there was published a generally recognized 

as safe list and there was a specific substance which happens to be a 

byproduct in the industry which was removed from the generally 

recognized as safe list. It happens tha t this particular substance is 

safe and it is my understanding tha t an extension is being granted, 

but that, of course, is prio r to Alarch 6, 1961, so my concern, sir, was 

suppose this very same thing should happen after Alarch 6, 1961 in 

the light of the language of II.R. 3908, without the amendment, and 

all we were hoping to do for the benefit of the people and the Depart­ ment of H ealth, Education, and Welfare, was to carry out tha t second 

pa rt of the statement referred to in the letter of transm ittal, sir. It 

has happened once, sir, it could happen again.

Air. Dingell. You heard the comment of Commissioner Larrick on 

this point. Does that not appear to satisfy any objection you might 

have to the bill as drafted ?

Air. Boyd. If I could be assured Commissioner Larrick would be 

here at all times, I would not have any worry.

Mr. Larrick. I hope I will be.

Air. Boyd. Thank you, sir.

Air. Dingell. 1 think you have established a very clear legislative 

history this morning tha t it would be more inadequate protection.

The Chairman. Thank you very much.

Air. Boyd. Thank 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 hearing 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 hearing was adjourned, to reconvene at 10 a.m., Wednesday, Alarch 1,1961.)

FOOD ADDITIVES—EXTENSION OF TRANSITIONAL 

PROVISIONS

WEDNESDAY , MARCH 1, 1961

House of Representatives, 

Committee on I nterstate and F oreign Commerce.

D.C.

The committee met at 10 a.m., pursuant to recess, in room 1334, 

New House Office Bifilding, Hon. Oren Harris (chairman of the 

committee) presiding.

The Chairman. 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. Larrick, Commissioner of Food and Drugs, responding to a request of yesterday with respect to his authority in 

dealing with a substance which heretofore was considered to be safe, 

or which is not now a food additive. In view of the questions and 

discussion we had yesterday, I feel that it would be advisable to read 

this letter in order tha t everyone may have the benefit of it.

Since Commissioner Larrick is present, it might be well to ask 

him to present this letter.

Mr. Larrick. I would be delighted, sir.

STATEMENT 0E GEORGE P. LARRICK. COMMISSIONER, FOOD AND 

DRUG ADMINISTRATION

Mr. L arrick. May I say, sir, I have delivered 50 copies to the clerk 

of the committee so that he can distribute them to the people who 

are interested.

Should I proceed?

The Chairman. Yes; you may.

Mr. Larrick. This letter is dated February 28, 1961, addressed to 

the Honorable Oren Harris, chairman of the Committee on Interstate 

and Foreign Commerce, House of Representatives, Washington, D.C.

Dear Mr. Chairman : This is in response to your request, at the hearing on 

H.R. 3980, a bill to amend the transi tional provisions of the Food Additives 

Amendment of 1958, th at we supply the committee a statem ent as to the departm ent’s discretion in dealing with a substance which is not now a food 

additive, under that amendment, but which may sometime in the f utu re meet the 

sta tutory definition.

Fir st, it should be made plain th at the sta tus of a subs tanc e generally recognized as safe by qualified scientists, or of a substance for which there is a prior 

sanction, cannot change withou t some new scientific evidence. A prior sanction 

cann ot be with drawn unless the re is a fac tua l basis for withdrawal. We have 

comm itted ourselves in our regulations, except in cases of imminent hazard to 

health, not to with draw such a sanction withou t first providing a statement of 

the reasons for our action. Where the withdrawal of the sanction involves a 

single party or a limited number of parties, we give our reasons for withdraw al 

37
38 FOOD ADDITIVES

dir ec tly to thos e in te re st ed in it. W he re th is ca nn ot be done, th e no tic e is pu blish ed in th e Fed er al R eg is te r ex pla in in g wh y w ithdra w al is ne ce ss ar y. A su bs ta nc e ge ne ra lly recogn ized, as sa fe by qu ali fie d ex pert s is no t su bje ct to th e foo d ad dit iv es 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 ists. B ef or e th e sta tu s of an y su ch su bs ta nce ca n l>e ch an ge d, th ere m us t be new scientifi c d a ta which des troys th is univ er sa lly he ld be lie f as to it s sa fe ty . Nor­ mally, th is wo uld re quir e th e co mpleti on of scien tific st ud ie s an d th e pu blicatio n of th e re su lt s to dem ons trat e to th e sc ientifi c co mmun ity th a t it s lon g-h eld belief s a re no l on ge r w ar ra nte d. Second, even a ft e r a pri or sa nct io n h as been w ithdra w n, or th e sta tu s of a su bs ta nc e ge ne ra lly reco gn ized as sa fe has been ad eq ua te ly dra w n in to qu estio n, th e D epar tm en t st il l has th e bu rd en of pr oc ee ding w ith en fo rc em en t ac tio n, if it w ishe s to re quir e th e rem ov al of th e su bs ta nc e from 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 evide nc e in a civil ca se, or beyond a re as on ab le do ub t in a cr im in al case, th a t th e su b­ st an ce mee ts th e de fin ition of a foo d ad di tive , as it appears in section 20 1( s) of th e Fed er al Food, Dru g, an d Co sm etic Ac t, an d th a t th e su bs ta nc e is no t 

w ithin t he gr an dfa th er- cla use ex em pt io ns in th a t defin ition . The se fe atu re s of th e law , as a pra cti cal m at te r, mak e it ex trem el y un lik ely th a t th e sta 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. We con ­ si de r it our re sp on sibi lity to co m m un icate an y new fa cts ab out an ex em pt su b­ st an ce to th e scientifi c co mm un ity an d to pe rson s know n to be d ir ec tly in te re st ed in it. Thi s wo uld giv e ad va nc e no tic e of th e pe nd ing ch an ge an d an o pp ortunity eit h er to s ta rt th e pre par at io n of a foo d ad ditiv e pet itio n to es ta blish sa fe ty or to su pp ly co nt ro ver ting ev iden ce w ith re sp ec t to t he new scientifi c deve lopm en ts. W he n th e new scienc 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 long er be ge ne ra ly reco gn ized as sa fe , or es ta blish es th a t th e pri or sa nc tio n was gra nte d un de r a m is ta ke as to th e su pp os ed sa fe ty of th e ar ticl e, th e D ep ar t­ m en t wo uld ha ve to cl as sify it as a focal ad di tive . It wo uld then be su bj ec t to se iz ur e un de r th e foo d ad ditiv es am en dm en t, unt il a re gu la tion w as pr om ul ga te d 

perm it ti ng i ts sa fe u se. It is he re th a t th e dis cr et io n m en tio ne d [in my testim on y yes te rd ay come s] in to pl ay . T he D ep ar tm en t is no t bo un d to pro ceed im m ed ia tely ag ai nst ev ery 

ad u lt era te d ar ticl e. The Su prem e Cou rt, in United Sta te s v. Sull iv an (332 U.S. 

68 9), has mad e it cle ar th a t th e depart m ent ha s been giv en br oa d disc re tio n, “br oa d enou gh un do ub tedl y to en ab le (t h e Com miss ione r) to per fo rm his dut ie s fa ir ly w ithout w as ting hi s ef fo rts on w h at may be no more th an te ch ni ca l in ­ fr acti ons of th e law.” An d th e C our t sa id th a t th e scope of th e law shou ld no t be nar ro w ed by “e nv isioni ng ex tr em e jio ssible ap pl ic at io ns of it s pr ov isions .” More re ce nt ly th e Cou rt, is an op inion by Chief Ju st ic e W ar re n in R ath burn v. 

United Sta te s (355 U.S. 107, 10!)), has sa id : “E ve ry st atu te m us t be in te rp re te d 

in th e ligh t of re as on an d com mo n unders ta ndin g to re ac h th e re su lts inte nd ed 

by the le gis la tu re .” App lying th is ru le of reas on , an d ex er ci si ng th e disc re tio n re fe rr ed to by th e Su pr em e Cou rt, th e D ep ar tm en t wo uld be ab le to cope w ith th e si tu ati on in which a lon g-used su bs tanc e, eit her on th e gen er al ly rec ogniz ed as sa fe list or tho su b­ je ct of a pri or sa nc tio n, is th ro wn in to qu es tion un de r th e food ad ditiv es am en d­ men t. If th e qu es tion ar ose sim ply be ca us e it was lear ne d th a t som e su bs ta nc e of un kn ow n id en tity m ig ra te d fr om pa per bo ar d, th e depar tm en t wo uld no t be compe lle d to im m ed ia te ly in it ia te a se iz ur e ca mpa ign again st al l pap er boa rd im ck ag ed food. B ut i f it w as le ar ne d th a t th e m ig ra nt was one ab ou t which th er e w as a se riou s qu es tio n of sa fe ty , or one of un kn ow n toxi city , th e D ep ar tm en t sh ou ld ha ve th e auth ori ty to proc eed in th e pu blic in te re st . T his ki nd of ac tion 

is p er m it te d by th e p er m an en t p ro vi sion s of th e a ct. Thus adeq uat e fle xibi lit y in adm in is tr ati on al re ad y ex ists. We do no t belie ve th a t th e law sh ou ld pr ov id e fo r exte nsi ons fo r all su bs ta nc es th a t may a t an y tim e h ere aft er be fo un d to be foo d ad di tives . Th e pu rp os e of th e food ad di tive s am en dm en t is to pr ov ide, a ft e r a re as ona ble tr ansi ti on pe riod , th at ad di tive s sh al l m ee t al l re quir em en ts w ithout ex ce pt ions . Mo reo ver , th e po ss ib ility th a t a su bs ta nc e th ou gh t no t to be w ithin th e scop e of th e food ad ditiv es am en dm en t m ig ht a t som e fu tu re tim e tu rn ou t to be w ithin it s scope, is in her en t in ev ery pr ov ision of re gula to ry law , in cl ud in g oth er pr ov isions of th e Food. Drug, an d Co sm etic Act, an d it wo uld m an if es tly be un so un d to c re ate po ssible loo phole s re ­

la ti n g to all th es e si tu at io ns . We re ce nt ly review ed th is who le m att er w ith re pre se nta tives of the ch em ical in dust ry an d as ke d fo r an y co nc re te ex am pl es th a t mig ht ju sti fy a per m an en t pr ov isio n in th e law auth ori zi ng th e D epar tm en t to ex tend it s effecti ve ne ss fo r
FOOD ADDITIVES 39

2 ye ar s, or an y ot her pe rio d, w hi le ne w sc ientifi c pr ob le m s ari si ng w ith re sp ec t 

to an old ad di tive w er e ex plor ed . No su ch ex am pl es co uld be giv en to us, an d 

ab se nt such an ex am pl e we ca nn ot reco mmen d mod ifi ca tio n of tlie hill to a u ­

th or iz e such a n ex tens ion.

I t m aj' he th a t som e su bs ta nc es w hi ch w e ha ve list ed as g en er al ly r ec og nize d as 

sa fe , an d som e fo r wh ich we ha ve gra nte d pri or sa nc tion s, will ch an ge in sta tu s 

w ith th e em erge nc e of new sc ientifi c know led ge. If th ey do, th e new kn ow ledg e 

wo uld ha ve to es ta bl is h a se riou s qu es tion of do ub t of sa fe ty . In an y su ch case, 

we believe th e be st co ur se wo uld be to rem ov e th e su bst an ce from th e fo od su p ­

pl y while the issu e of do ub t w as being remov ed ra th e r th an to a pp ro ve a bla nket 

ex tens ion. If th e do ub t were not a se riou s one, th ere wo uld be no ne ed fo r 

im m ed ia te a cti on .

Add iti on ally , as de ve lope d by som e of th e m em be rs of th e co mmitt ee d uri ng t he 

he ar in gs , th e prop osed de letion from su bs ec tio n (c ) of se ction G of th e foo d 

ad ditiv 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 dit iv e b efor e 

Ja n u a ry 1 ,195 8” and s ubst itution th ere fo r of t he w or ds “ if the su bs ta nc es m ak in g 

up such ad ditiv e w er e si m ilar ly us ed be fo re Ja n u a ry 1, 1958” wo uld w ea ke n th e 

pre se nt co nc ep t of th e focal ad ditiv es am en dm en t an d of th e ad di tional ex te ns io n 

au th o ri ty co nt em pl at ed in 1I.K. 3980. II .It. 3980 is in te nded to a llo w u s to g ra n t 

fu rt h e r ex tens 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 dit iv e 

be fo re Ja n u ary 1, 1958. The am en dm en t prop os ed by th e American P a p e r & 

P ulp Assoc iatio n wou ld g re atl y ex pa nd th is au th o ri ty an d wo uld au th ori ze ou r 

depar tm en t to g ra n t ex te ns io ns fo r var io us us es of a give n ch em ical so long a s it 

had been used in a so m ew ha t re la te d m an ner be fo re Jan u ary 1, 1958. As I 

men tio ne d in my testim on y, th is re quir em en t th a t a su bs ta nc e to be gra nte d 

fu rt h e r ex tens ion m ust ha ve been us ed pri or to Ja n u a ry 1, 1958, give s ad de d 

su pp or t to th e de cision s of our sc ie ntist s th a t fu rth e r lim ited ex tens ion w ill be 

w ithout un du e ri sk to th e pu blic h e a lt h ; th is ad de d su pport wo uld no t exis t fo r 

ne w us es of th e sa m e ch em ic als which had no t been su bj ec te d to the te st of tim e. 

Sinc er ely yo ur s,

George P. Larr ick,

Commissioner of Food and Drugs.

The C ha irman . T han k you very mu ch, M r. Lar rick .

We will now he ar fro m Mr. Ken ne th M ul fo rd , ch airm an , Fo od 

Add iti ve s Co mmi tte e, M an ufa ct uri ng C he m ists’ A sso cia tion.

STATEMENT OF KENNETH E. MTJLFORD, CHAIRMAN, FOOD ADDITIVES COMMITTEE. MANUFACTURING CHEMISTS’ ASSOCIATION.

INC.

Mr. Mulford. M r. C ha irm an an d me mb ers of th e comm itte e, w ith 

your pe rm ission 1 sugg est, in ord er to co nserve tim e, th at , as I di d 

ye ster da y, th e pre par ed stat em en t which ha s been su bm itt ed to you 

be in co rp or ated in to the r ec ord, to ge th er w ith the a cc om pa ny ing le tter 

da te d Feb ru ar y 21, 1961, from Gen eral H ul l, pr es id en t of t he associatio n to th e c ha irm an o f th is com mittee.

The Cha irman . Le t it lie i ns erted in th e r ecord.

(T he docume nt re fe rr ed to is as f ol lo w s:)

State m ent of K e n n e t h E. Mulford on B eh a lf of t h e Manufa cturin g

C h e m is t s ’ A ss ocia ti on, I nc.

Mr. Cha irm an and mem be rs of th e co mmittee , my na m e is Ken ne th E. Mu lfo rd . I am ch ai rm an of th e Fo od A dd iti ve Com mitt ee of th e M an ufa ct uri ng 

Che m ists' Assoc iatio n. Th e M an ufa ct uri ng C he m is ts’ Assoc iatio n is a tr ad e 

as so ci at io n com posed of 190 co rp or at e mem be rs which a re en ga ge d in th e 

m anufa ctu re of ch em icals .

Am ong th e pro du ct s sold by ch em ical pro du ce rs are pro duct s wh ich become 

fo od co mpo ne nts eit h er in te ntional ly to per fo rm some fu nc tion in th e foo d, 

or un in te nt io na lly, as. fo r ex am ple, m ig ra nts from food w ra pp er s. B ot h th e 

in te nt io nal an d unin te ntional foo d co mpo ne nts are su bje ct to th e co ntrol s of 

th e Food A dd iti ve s Amen dm en t of 1958 un le ss th ey a re us ed fo r co lorin g foo d,
40 FOOD ADDITIV ES

in which case they are subject to the Color Additive Amendments of 1960.

Under d ate of February 21, 1961, Gen. John E. Hull, president of the Manufacturing Chemists’ Association, wrote a letter 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 it into the record. (See le tter below.)

As I believe the lette r to be self-explanatory as to the position of the Manufacturing 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 behalf of the Manufacturing Chemists’ Association.

Manufacturing Che mists’ Association, I nc.,

'Washington, D.C., February 21, 1061.

Hon. Oren Harris,

Chairman, Committee on Interstate and Foreign Commerce,

House of Representatives,

Washington, D.C.

Dear Mr. Har ris: Our association has carefully studied H.R. 3980, a bill 

introduced by you to amend the transitional provisions of the Food Additives 

Amendment of 1958 and the Nematocide, Plant Regulator, Defoliant, and 

Desiccant Amendment of 1959. Your bill appears to be the same as that 

suggested originally by former Secretary Flemming in a communication dated 

January 13, 1961. On Thursday, February 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 that he hoped your committee 

would take favorable action on the proposal as soon as jiossibie.

Our association believes t hat it would be better to have legislation giving the 

Secretary of Health, Education, and Welfare broad administrative discretion 

to grant extensions under the two amendments mentioned above after March 

6, 1961, if he found tha t there were reasonable grounds for not having complied with the prerequisites of the amendments.

However, due to the very short period of time before the March 6 deadline, 

we would like to call to your attention only one minor point. Both in section 

2 and in section 3, the Secretary of Health, Education, and Welfare may extend the effective dates of the two amendments where he has already extended 

the effective date to March 6, 1961. This language would mean that in cases 

where a manufacturer has in good faith filed with FDA a request for an extension and FDA has not been able to act on such a request, then such a manufactu rer would be ineligible for an extension after March 6, 1961. We understand that the Food and Drug Administration 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 manufacturers 

who have filed requests for extensions without 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 resulted in a number 

of problems for the Food and Drug Administration and for affected industries. 

Many manufacturers have diligently sought to learn whether their products 

were food additives as defined by the act. In many cases, it has only been with 

furth er refinement of analytical techniques tha t manufacturers were able to 

conclude th at they did have food additives subject to the act. Also, it is well to 

point out that many required animal tests cover a long period of time.

We respectfully urge that your committee as soon as possible report favorably 

H.R. 3980 with the one amendment referred 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 appear and testify in support 

of the bill.

Sincerely,

J. E. Hull.

Mr. Mul/ford. I will then direct a few remarks to the committee.

First, briefly, the position of our association is that while we would 

prefer to have the Secretary have greater discretionary power in
FOOD ADD ITIVES 41

grantin g extensions, we feel that March G is not only just around the 

corner, but we are practically stumbling over it, and, therefore, under 

the circumstances we feel that this bill, H.R. 3980, should be prom ptly 

passed, amended as suggested yesterday by Commissoner Larrick in 

his testimony.

Now I would like to comment as to why we put this prefatory 

statement in, that we feel th at the Secretary should have more discretionary power. I would like to emphasize t ha t we do not feel this 

is desirable in any case where there is a public health problem involved 

or any undue risk to public health. We only felt tha t the Commissioner should have this authority in the event that some technicality 

comes up under the present law th at would appear on its face to prevent him from grantin g an extension when there had been no question 

about the safety of the product, but the person or ingredient just 

happened to be part under some unfortunate circumstances.

In discussing this with representatives of the Food and Drug Ad ­

ministration, the conclusion was reached that perhaps here this is not 

necessarily something that, should be taken up in this extension bill. 

As Commissioner Larrick 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 that, rather than try and 

straighten such a matter out at this time, the present bill should be 

passed with the amendment that Commissioner Larrick has suggested.

The other point I would like to comment on is the suggestion made 

yesterday that an overall time limit be placed on this bill. Back in 

1958, when we had no idea of the terrific magnitude of this problem, 

the Manufacturing Chemists’ Association position at that time, and 

the testimony, was that it would take at least 5 veal’s to get his matter straightened out. I just won’t take the time to go into the tremendous number of problems involved in compliance with this act, 

and the wonderful job that I think both industry and the Fcxxl and 

Drug Administration has done in the time that we have had so far.

T would like to say, however, that a great deal more time is going 

to be needed. And, if it is the judgment of your committee that an 

overall time limit should be placed on this extension bill, then it should 

l ie at least 5 years and certainly no less than 3.

I think that concludes my statement, Mr. Chairman.

The Chairman. Any questions by members of the committee?

(No response.)

The Chairman. Thank you very much. We are very glad to have 

your testimony, Mr. Mulford.

Mr. Mulford. Than k you.

The Chairman. Mr. II . E dward Dunkelberger, Jr., of the National 

Canners Association.

STATEMENT OF H. EDWARD DUNKELBERGER, JR.. COUNSEL, THE 

NATIONAL CANNERS ASSOCIATION

Mr. Dunkelberger. My name is H. Edward Dunkelberger, J r., and 

I am appearing on behalf of the National Canners Association. We 

would like to express our appreciation to the chairman and the committee for this opportunity to present this statement to the committee.

The National Cannel’s Association, on behalf of its members, urges
42 FOOD ADDITIVES

that, this committee give immediate and favorable consideration to 

H.R. 3980. Because Secretary Flemming in his letter of transm ittal 

to Speaker Rayburn and Secretary Ribicoff in his statement before 

this committee fully outlined the need for this legislation, we will 

coniine this statement to noting our agreement with that letter and 

the accompanying explanation and the Secretary's statement yesterday. 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 that purpose is to be satisfactorily carried out. Under the bill as presently drafted, and even with the amendment 

tha t Commissioner Larrick proposed yesterday, the Food and Drug Administration will be obliged to give individual consideration to 

each of the 3,000 extensions which have already been granted under 

the present act, for in no other way can it be determined whether 

further extensions would meet the specific requirements of the bill. 

Only if these requirements are met would a further extension tie 

authorized. It seems clear beyond question that there will not be time after 

the enactment of this bill and before March 6—indeed, if it comes in 

that order at all—for all interested parties to present information 

establishing that the additional requirements of the bill have l>een 

satisfied with respect to substances covered by outstanding exemptions. Even if such information were in the hands of the Department, it is unrealistic to suppose that Department personnel will have 

time prior to March 6 to examine and pass upon this information for 

all 3,000 extensions. In addition to passing upon extensions and sending extensions, the Department staff will, of course, be actively engaged in processing petitions for final regulations listing food additives for use. If these assumptions are correct, then it follows that on March 6, 

or upon whatever date even after the act is enacted, the present extensions will expire and thousands of food products will be in technical violation of the act until such time as the Department has acted 

upon each of the extensions pending or previously granted.

We feel it is necessary, therefore, that H.R. 3980 be amended to 

provide an additional 6-month period or whatever period the FDA 

feels is necessary, during which all present extensions to consider 

and act on further extensions for each of the food additives for which 

an extension is in effect or is pending, and at the same time to continue to process petitions for regulations. This 6-month or 7-month blanket extension could be written into 

the bill by striking out the word “he” in line 5, page 2, and inserting 

the following language after the words “food additive,” in line 4 

on page 2:

such effective date shall be further extended with respect to such use of the additive to September 0. 1961, and the Secretary.

And then it would continue on. That September date, of course, 

could be changed to whatever period is desired to be necessary. The 

same amendment, if it is thought to be necessary, could be added to 

section 3 of the bill.

The Chairman. Mr. Springer.
FOOD ADDITIVES 43

Mr. Springer. Could I ask Commissioner Larrick a question?

Do you have any objection to the suggested amendment?

Mr. Larrick. Mr. Springer, I had anticipated tha t the question 

would be asked and one of my able assistants has written out the question and answer. And if I may, 1 would like to read it.

Qu estion . W lia t ha pp en s on M arch 6, 1961, even th ou gh II.R . 3980 wer e en ­

ac te d? It seem s th a t FD A wo uld ha ve insu ffi cie nt tim e to co ns ider th e m an y 

re qu es ts fo r ex te ns io ns th a t will be f or thco min g.

Answe r. If II.It. 3980 is en ac ted, we will ad vi se th e affecte d in dust ri es th a t 

we are re ad y to co ns id er re que st s th ey wish to m ak e fo r fu rt h er ex te ns io ns of 

th e eff ectiv e d ate of th e law . W e will al so ad vi se th em th a t fo r a re as onab le 

pe riod of tim e to perm it ev al uat io n of th eir re qu es ts th e ex is ting ex te ns io ns 

w ill no t l>e c an ce led. It wo uld appear to us th a t a co up le of mon ths wou ld be 

a re as on ab le tim e w ithin whi ch to han dle addit io nal re ques ts fo r ex tens ions .

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. Larrick. We would not object. We are going to do it anyway.

Mr. Springer. Tha t is all.

The Chairman. Mr. Keith.

Mr. Keith. I am not an attorney, but it would seem to me that the 

action he contemplates would be outside the law, and tha t in order 

for him to do what he says he would do anyway we would necessarily 

have to make this amendment.

The Chairman. I see no partic ular reason to belabor the point one 

way or the other because I think definitely they would have the 

authority if we passed the legislation. And if it is going 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 rther questions?

Mr. Moss. I have one question of Mr. Larrick on this point.

This would have the effect of giving extensions on all matters for 

6 months?

Mr. Larrick. No; it would not have that effect. It would mean 

that if someone in good faith-----

Mr. Moss. No; I mean the proposed amendment.

Mr. L arrick. Oh, this 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 that is in the public interest.

Mr. Moss. That is all.

Mr. Dingf.ll. Mr. Chairman, could I ask the previous witness, not 

Mr. Larrick, just one brief question ?

The Chairman. Mr. Dingell.

Mr. Dingell. You said, your suggested amendment is:

su ch eff ectiv e date sh al l be fu rth e r ex te nd ed w ith re sp ec t to such use of th e 

addit iv e to Se ptem be r 6, 1961, an d th e S ecr et ar y—

Now, have you had any experiences with the Food and Drug Administration under the existing law which would, in your 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 technically there was no authority for blanket extensions in the bill. Each
44 FOOD ADDITIVES

extension has to be considered separately as the bill is now written. 

And there has been great emphasis made on this point, tha t each extension would be considered separately. And, therefore, when March 

6 came and went there would not be time for all 3,000 to be considered tha t way. So we thought there should be a brief period 

authorized in the law authorizing the FDA to gran t a brief time 

during which all of them can be considered, and then everyone would 

get off to the same start again with no technical violations of the law.

Mr. Dixgell. Tha t is a very good answer, but it does not come right 

to the point I was exploring, and tha t is th is : Have you had any 

experiences with the food and drug tha t would indicate to you tha t 

this amendment is necessary, any specific experiences ?

Mr. Duxkelberger. No ; we have had no experience that the FDA 

would take advantage—as a matter of fact, the Commission has already indicated they would not, and we have no experience they 

would take advantage—or what we would say is a technical defect 

in the bill, to take unf air advantage of industry. We have no experience whatsoever that they would do that.

Mr. Dixgell. I am not a believer in enacting unnecessary legislation if 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 the Commissioner has assured us, he 

will grant this anyway whether it is enacted into the bill or not. 

It would seem th at the need for the amendment, therefore, is somewhat diminished, but it is required technically within the wording of 

the bill that is now written.

Mr. Dixgell. Thank you very much.

The Chairman. In other words, if it is going to be done, you do 

not care whether it is in there or not ?

Mr. Dux’kelberger. Tha t is right, sir.

The Chairman. Thank you, very much.

Mr. Michael F. Markel.

STA TEM ENT OF MICH AEL F. MARKE T, FOOD, DRUG, AND COSMETICS 

SECTION, NE W YORK BAR ASSOCIATION

Mr. Markel. Mr. Chairman, I do not have a prepared statement. 

I do appear here in behalf of what I recognize as an organized group 

of lawyers who are very much interested in this whole problem. And 

in demonstrating my authorization to speak, and giving my qualifications, I would like to say that the lawyers in the food, d rug and cosmetics field are organized formally. We are a division in the corporation, banking, and business law section in the American Bar Association. I am a chairman of th at division, and I am a member of tlie 

council of that 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 group of lawyers is also organized 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 ADDITIVES 45

division. I am a member of a number of the ir committees, and last 

Jan uar y at their annual meeting I was appointed chairman of the 

resolution committee, and we adopted a resolution, as the lawyers, 

and not as a bar group, supportin g this bill.

Upon adoption of the resolution a committee was appointed to follow through on this with the Food and Drug Administration and 

to assist this committee, and I was appointed chairman of th at committee. 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 Washington, and we have a great deal of work in this area. I have been 

concerned with this problem ever since before there was a food additive amendment. And at the risk of appearing immodest, I want to 

say that in 1948 I wrote a paper, which was published, where I suggested that it was time to consider legislation such as the food additive amendment, and advised the food industry tha t they ought to 

give serious heed to this. At tha t time I was a lone voice in the wilderness. 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 Administration, and we did discuss 

this bill. And Commissioner Larrick yesterday did suggest revision 

of language which will take care of what our committee wanted to 

take care of: namely, tha t the language should be extended so as 

to include all matters now before the Food and Drug Administration. That is, extensions, pending petitions, and pending requests for 

a ruling. And that, is the revision that Air. Larrick 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 promptly passed.

During tha t discussion there also came up the problem tha t has 

been discussed at some length here. It was readily apparent to us, 

and to me, that that has no place in this bill. We are mixing apples 

and pears here. This matter was something that may come under the 

other side, something tha t would require a fundamental amendment 

of the act. There will be cases such as that for this reason: The single 

judicial question remaining in this whole area is the question which 

will arise if some manu facturer of a substance chooses to disagree 

with the Food and Drug Administration as to whether 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 group and some of the food 

groups are concerned about.

For example, last week one industry 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 appointed say we have concluded this is generally recognized as safe.” Now supposing tha t 

the Food and Drug Administration 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 right, let’s file a 

petition.” So there is this possibility. But there is no present problem, and tha t should be separated and should be the subject of consideration 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 ADDITIVES

tension in any sense of the world; it is a broadening of administrative 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 

majority of the food and drug lawyers in this instance who understand it, and I would say I could convince the majority 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 thought that perhaps 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 demonstrable problems, and in view of what the Commissioner said yesterday, we have concluded, and our committee has concluded, 3 years 

will do. And we are perfectly happy to accept that.

Now’ there 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 yesterday in quoting Mr. Depew, Franklin M. Depew, president of the Food 

Law’ Institute. I want to assure Mr. Delaney through this committee—and I spoke to Mr. Delaney yesterday afternoon about this—that 

Mr. Depew’ was fully in accord with what I have said. I know’ him; 

I am a member of the advisory legal board of the Food Law’ Institute. 

It is a most highly responsible organization, 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 the statement that Mr. 

Delaney read came from that paper evidently. But I want to assure 

this committee that the organized industry, regulated industry, has 

no intention of diluting anything here, and particularly not the Food 

Law Institute. And Mr. Depew, I want to say, is in accord with 

everything th at I have said. So we recommend very strongly that we 

promptly pass this bill with the amendments that Commissioner Larric.k has suggested, and that when and if the need arises, and they, are 

prepared to demonstrate the need for amending the basic act so as to 

take care of the other problem, there will be time enough to take tha t 

up when we have more time to discuss it.

Thank you very much, Mr. Chairman.

The Chairman. Thank you very much, Mr. Market.

Any questions by members of the committee?

Than k you, w’e appreciate having your statement.

This will conclude the hearing on 11.R. 3980.

(The following material was submitted for the record:)

T h e F ood L aw I n st it u t e, I nc.,

New York, N.Y., March 3, 1961.

Re H.R . 3980, Fo od A dd iti ve s T ra nsi ti onal Pro vi sion s Amen dm en t of 1961.

H o n . Oren H arris ,

Chairman, House Comm ittee on I ntersta te and Foreign Commerce, House Office

Building, Washington, D.C.

Dear Mr. H arris : The Fo od Law In sti tu te w as an d re m ai ns a st an ch su pport er of th e Fo od A dd iti ve s Amen dm en t of th e Fed er al Fo od , Dru g, an d Cosm etic Ac t, who se H ou se re port and pas sa ge yo u su cc es sful ly di re ct ed as 

ch air m an of th e Hou se In te rs ta te and For ei gn Co mm erc e Com m itt ee in 1958. 

My pr ed ec es so r. Mr . C har le s W esley D un n, a s long as 10 years 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 tion of th e pu bl ic hea lth.
FOOD ADDITIVES 47

We now ur ge yo ur co m m itte e’s ap pro va l of th e bill H.R . 3980, th e Food A dd i­ tive s T ra nsi ti onal Amen dm en t of 1961. Thi s am en dm en t af fo rd s th e nec es sa ry addit io nal tim e to co mplete in ve st ig at io ns of v ar io us old su bst an ce s to d et er m in e th e ir sa fe ty fo r food use under ap pr ov ed co nd iti on s, an d su bje ct to str ic t a ssu ran ce s of c on su mer p ro tectio n. W e also ur ge yo ur ap pro val and re co m m en da tion of tw o po ssible re vi sion s of th e b ill: fir st, to en la rg e it s ap pl ic at io n so th a t re quest s fo r ru ling s an d pe ti- ti ons fo r re gu la tion s no w pe nd ing be fo re tli e Sec re ta ry m ay qu al ify, as well as m a tt e rs a lr ea dy su bj ec t to an ex te ns io n ; and , sec ond, to h av e an y tim e li m itat io n (i f one is in se rted in th e bi ll) carr y th e S ecre ta ry ’s dis cr et io n fo r gra n ti n g ex ­

te ns io ns , a t le as t i nto th e m id dle of 1964. Ple 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 appea ra nce a t 

th e re ce nt h ea ring s on th is b ill h eld by y our committee .

I a m, w ith co rd ia l r eg ar ds ,

Res pe ctfu lly yo urs,

F ra nk li n M. Dep ew , P re s id e nt.

F ebruary 25, 1961.

Com mi ttee on I nte rst ate and F oreign Comm erce,

House Office Building,

Washington, D.C.

Dear Sir s : Th e m em be rs of th e B ridg ew at er H om em ak er s Club re sp ec tfully pro te st d ra ft bil l II. R. 3980, re fe rr ed to by ti tl e “Fo od A dd iti ve s T ra nsi ti onal Pro vi sion s Amen dm en t of 1961”, to am en d th e tr an si ti o n al pr ov isions of th e 

act ap pr ov ed Se ptem be r 6, 1958. T hi s law , we a re cert ain , is no t in th e pu blic in te re st an d shou ld be de ­ fe at ed , be ca us e it d efe ats th e pu rp os es of th e act ap pr ov ed Se ptem be r 6, 1958. by circ um ve nt in g it s tw o sa fe ty cla use s: (1 ) “to pro hib it th e use in th e food of ad ditiv es wh ich ha ve no t been ad eq uat el y te st ed to es ta blish sa fe ty .” (2 ) T he D elan ey ca nc er cl au se which “rule s ou t a su bst an ce if it is foun d to in ­ du ce ca nc er in man or an im al , aft e r te sts which a re appro pri ate fo r th e evalu atio n of th e sa fe ty of food ad ditiv es .” It also giv es th e Fo od an d Dru g A dm in is tr at io n un lim ited au th o ri ty to ex tend th e us e of th es e toxi c ch em icals, a t th eir pl ea su re . O ur st udy of th e ac tion s of th e Fo od an d Dru g A dm in is tr at io n in th e pa st , giv e us li tt le confi dence th a t th is au th o ri ty wi ll be used in th e pu blic in te re st ra th e r th an in th e in te re st of th e 

food pr oc es so rs an d m anufa ctu re rs . We ho pe you will be in te re st ed in th e follo wing se lected bibl iogr ap hy which 

we pre se nt as th e ba si s fo r our st at em en ts .

1. A gr ic ul tu re D ep art m ent's w arn in g on th e su bj ec t, in a co nfiden tia l re port pr ep ar ed by R al ph Trigg of th e Pro du ct io n an d M ar ke tin g Divisi on fo r Sec re ta ry C har le s B ra nna n. T his ap pe ar ed in th e W as hi ng ton Pos t 

Ma y 3. 1949. 2. A le tt er fr om D r. W illiam E. Sm ith to Con gr es sm an .Tames J. Delan ey of New York— Con gr es sion al Re co rd of th e 85th Co ng ress, 1st ses sio n.

3. “T he Po iso ns in Our Fo od ”—by W ill iam Lo ngg ood .

4. Fo od an d D ru g A dm in is tr at io n Rep or ts.

5. The New York Ti mes.

Sincerely ,

Bridgewater H om em ak ers Club, 

J ose ph in e P. S hive ly ,

Editor, Woman's Health News, Route 2, Quaker City, Ohio.

Nopco Che mi ca l Co., 

Newark, N.J., February 24, 1961.

S u b je c t: H.R. 3980, Fo od Add iti ve s T ra nsi ti onal Pro vi sion s Amen dm en t of 1961. 

Ho n. Oren H arr is,

Chairman, House Interstate and Foreign Commerce Committee,

House of Representatives,

Washington, D.C.

Si r : As a ch em ica l m an ufa ctu re r, ou r co mpa ny is v it all y in te re st ed in an y ac tion Co ng ress may ta k e in co nn ec tio n w ith th e ab ov e-iden tif ied bil l. As you are well aw ar e, th is bill, am on g oth er th in gs , will em po wer th e Sec re ta ry of th e D epar tm en t of H ea lth, Edu ca tion , an d W el fa re to g ra n t, und er appro pri at e
48 FOOD ADD ITIVES

circumstances, furth er time extensions with respect to food additives which 

are now being marketed under time extensions. We are, of course, in complete accord with the purpose of thi s bill and respectfully urge its passage. 

The chemical industry, as a whole, is in need of additional time to fully comply with the requirements of the Food Additives Amendment to the Federal 

Food, Drug, and Cosmetic Act.

The foregoing notw ithstand ing, however, we wish to sta te tha t, in our 

view, th e proposed bill, as drafted, is, in one respe ct at least, fa r too restrictive. 

H.R. 3980 reads, in pa rt as follows:

"Whenever the Secretary has * * * extended the effective date * ♦ * to 

March 6, 1961. with respe ct to any such particular use of a food additive, he 

may * * * furth er extend such effective date * * * with respect to such use 

of the additive (or a more limited specified use or uses thereof) if * * * he 

finds (i) that bona fide action to determine the applicability of such section 

409 to such use or uses, or to develop the scientific data necessary for action 

under such section, was commenced by an interested person before March 6, 

1960, and was there aft er pursued with reasonable diligence. * * *”

The proposed bill makes no allowance for the grant of furth er time extensions 

in the case of food additives, now sold unde r time extensions, where no steps leading to compliance with the food additives amendment had been initiat ed in 

connection therewith on or before March 6, 1960. The prim ary purpose of this 

restriction is self-evident. II.R. 3980, in effect, rew ards diligence. However, the 

language of th e bill is such th at it will have the effect also of penalizing companies 

who failed to act prior to March 1, 1960, in connection with an additive, not because of lack of diligence, but because no action was deemed necessary. For example, cer tain prod ucts of our manuf acture are, and for many years have been, 

sold for use in the processing of textiles. We were not, on March 6, 1960, aw are 

of the f ac t t ha t pa rticular products in our line of textile chemicals were used for 

purposes which would, or could, bring them within the scope of the Federal act. 

It was not until impurities were received, subsequent to March 6, 1960, from 

custom ers for these products, that we became cognizant that they were, or could 

be considered as “food additives.” Upon receipt of such inquiries, we filed with 

due diligence, requests for time exten sions with the Food and Drug Adm inistration in connection with these products.

It is re spec tfully submitted t ha t the proposed legislation, the purpose of which 

is to empower the Secretary of the Departme nt of Health, Education, and Welfare 

to gra nt fu rth er time extensions, should permit the Secretary the use of discretion in any case having unusual circumstances. H.R. 3980, as now written , 

does n ot gran t the Secretary such discretionar y power. Rather, H.R. 3980 will 

preclude the Secretary from granting relief undew circumstances such as are 

heretofore described, to the d etriment both of the industry and the consumer.

Your consideration of th is m att er will be appreciated greatly.

Respectfully,

J ohn X. Gammon, Vice President.

Eastman Chemical Products, Inc.,

Kingsport, Tcnn., February 2.'/, 1961.

Hon. Oren Harris,

Chairman, Committee cm Interstate and Foreign Commerce,

House Office Building, Washington, D.C.

Dear Mr. Harris: As m arketer of a number of products which are covered by 

the food add itives amendment to the Food. Drug, and Cosmetic Act. we wish to 

urge enactmen t before March 6, 1961. of legislation enabling the Secretary of 

Health, Education, and Welfare to gra nt exten sions of the effective date of said 

amendment af ter said date. To this end, H.R. 3980 was introduced on February 

7. 1961. and referre d to your committee. This is a bill sponsored by the Secretary . We wish to urge its immedate enactment, with one change which we understand is agreeable to the Food and Drug Administration.

This is, th at instead of the requ irem ent th at to qualify for an extension of 

effective date after March 6. 1961, a food add itive must have previously been 

accorded such an extension to March 6, 1961, the sta tute pe rmit a furth er extension to March 6. 1961. has been gran ted or lias been requested 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 January 

13,1961:

"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 Amendment of 19.58—where extensions have heretofore been granted—before March 6, 

1961 (th e limit of our present authority to gran t extension of the transitional 

provisions) and because the affected industries will not be able to develop all 

necessary scientific d ata and petitions before tha t date even where appropriate 

action leading to such petitions was start ed in a timely manner.

Yours very truly,

M. C. Stone, Assistan t Secretary .

The Dowr Chemical Co., 

Washington, D.C., February 24,1961.

Reference H.R. 3980.

Hon. Oren Harris,

Chairman, Committee on Inters tate and Foreign Commerce,

U.S. House of Representative s,

Washington, D.C.

Dear Congressman Harris : 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 petitions may 

be pending action by the Food and Drug Administration on the present deadline dat e of March 6, 1961.

We firmly believe tha t conditions dictate the granting of the relief offered 

by this proposed legislation to manufacture rs of food add itives who have acted 

in good faith in attempting to comply with the provisions of the 1958 food add itive amendment, and urge prompt affirmative action by your committee and 

the Congress in clearing and enacting this vitally necessary measure.

Sincerely yours,

Russell A. Whitesell,

Special A ssistant to the President.

Nation al Cotton Cou nc il of A merica,

Washington, D.C. February 28, 1961.

Hon. Oren Harris,

Chairman, House Comm ittee on Intersta te and Foreign Commerce,

New House Office Building,

Washington, D.C.

My Dear Mr. Harris : The National Cotton Council, which is the overall 

organization of the raw cotton industry, representing cotton farmers, cotton 

ginners, cotton warehousemen, cotton merchants, cotton spinners, and cottonseed crushers, favors the enactment 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 granted under authority contained in the amendment. These extensions expire next month. There are 

several chemicals which have not yet been approved for cotton production. 

These are principally defoliants which facilitate 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 Administration and the manufacturers of some agricul tural 

chemicals to complete the necessary tests required under the food additive s 

amendment within the time limit allowed.

Accordingly, the time extension provided for in H.R. 3980, which you intro ­

duced, seems both reasonable and necessary. The National Cotton Council urges 

tha t your committee take favorable action on H.R. 3980 promptly.

Respectfully submitted.

J. B an ks Young.
50 FOOD ADDITIVES

Dix ie Cup Division of A merican Can Co.,

Eas to n, Pa., Feb ru ar y IS , 1961.

Ho n. J am es B. Utt,

Hou se Office Bui ld in g,

W as hi ng to n, D.C.

Dear Cong ressma n Ut t : As yo u are no do ub t aw ar e, we ha ve a fa ct ory in 

yo ur d is tr ic t in Ana he im an d a re th ere fo re ta kin g th e li ber ty of w ri ti ng you 

w ith re fe re nc e to a m att er which is of con side ra bl e i m port an ce to us.

T hi s le tt er co nc erns th e 1958 food ad ditiv es am en dm en t to th e Fed er al Food, 

Drug, an d Co sm eti c Act. You will re ca ll th a t th e gis t of th is am en dm en t is 

th a t no su bs ta nc e may he ad de d to a food un less it is ge ne ra lly reco gn ized by 

sc ie nti st s as ha rm le ss or has be en specifically ap pr ov ed by th e F ed er al Food 

and D ru g i>eople a ft e r th e su bm ission of th e re su lts of e xhaust iv e s cie ntific tests.

P ri o r to th e pa ss ag e of th is ac t, as we under st an d th e law , a foo d m an uf ac ­

tu re r m ig ht us e an y additiv e an d th e bu rd en w as on th e Fo od an d D ru g people 

to p ro ve t h a t th e a dditiv e w as h ar m fu l.

It is ge ne ra lly co nceded th a t th e addit iv e am en dm en t is a good piec e of legisla ti on an d w as pr ob ab ly ov erdu e. How ev er, it ha s posed m an y difficult prob lems 

fo r th e pa ck ag in g in dust ry due to th e po sitio n of th e Fo od a nd D ru g peop le th a t 

if th e mos t m in ut e tr ace of anyth in g fro m a food pa ck ag e ge ts in to th e food, 

it is up to th e se ller of th e foo d th us pa ck ag ed to dem onst ra te to th e Fo od an d 

D ru g pe op le th e exac t ch em ical n a tu re of th e su bs ta nce co nc erne d an d su bm it 

ex hau st iv e te st s to th e effect th a t su ch s ub st an ce is h ar m le ss .

The pa ck ag in g in dust ry in gen er al ha d bee n at te m pti ng to ap pl y a com monse ns e ap pr oa ch to th e su bje ct and perh ap s ha d no t be en too gre at ly co nc erne d 

whe n in dust ry ch em ists and consu lt ants ad vise d th a t th ere w as noth in g in th e 

pa ck ag in g which could diss olve in to th e food in a sufficie nt am ou nt to be harm ­

fu l. On th e oth er ha nd , th ere a re m an y co mpa nies which pro du ce fo od pa ck ag ­

ing. ea ch of which in th e p ast w as le ft to m ea su re th e pu blic w el fa re in th e 

ligh t of it s own ethi cs . T her ef ore we ag ai n mus t ge ne ra lly ag re e th a t th e additive am en dm en t us ap plied to food pa ck ag in g is pr ob ab ly a good thing.

The tes ting pr og ra m r eq uir ed by th e F ed er al F ood a nd D ru g peop le f or th e cle aran ce of a p art ic u la r “a ddit iv e” is mo st ex ha ust iv e an d th e pr oc ed ur es re ­

qu ired f or th e cl ea ra nc e of a sing le c hemi cal or com po un d may co st ov er $100,000. 

The on ly pra ct ic al ap pr oa ch fo r a co mpa ny such as ou rs, which pur ch as es its 

m ate ri als from man y diffe re nt sour ce s, ha s bee n to in si st th a t th e ve nd or s of 

th e m ate ri als in qu es tio n sell us on ly m at er ia ls which ha ve be en ap pro pri at el y 

cl ea re d by th e Fed er al Fo od an d D ru g people. In tu rn , be ca us e of th e la rg e 

ex jie ns e inv olved, man y su ppl ie rs of our ra w m ate ri als su ch as pa pe r, pl as tic s, 

wax es, an d ad he sive s, ha ve undert aken jo in t in dust ry pro gr am s fo r th e te st in g 

an d cl ea ra nc e of th eir m at eri als . The FD A under st an ds th is an d is in ag re emen t w ith such a pr oc ed ur e, sin ce it also redu ce s FD A m an po w er re quir em en ts 

if m ate ri als a re cl ea re d in an ord er ly way by grou ps which re pre se nt mo st of th e 

pr od uc er s in a p art ic u la r line.

The ad ditiv es am en dm en t give s th e Fo od and Dru g A dm in is tr at io n po wer to 

g ra n t cert ain ex te ns io ns of tim e duri ng wh ich “u ncl ea re d” ite ms ma y co ntin ue 

to be used if FD A is co nv ince d th a t th e publi c will no t be ha rm ed . A gre at 

man y, if no t mo st, co mpo ne nts a re pr es en tly being used in food pa ck ag in g pursu ant to such ex tens ions . On e such ex am pl e is a pe trol eu m wax wh ich is 

pr es en tly un de rg oi ng e xhau st iv e te st s un de r th e au sp ic es of th e Amer ican P etr oleu m In st it ute . The au th o ri ty of th e Fo od an d D ru g A dm in is trat io n to g ra n t su ch ex tens io ns 

an d th e ex te ns io ns her et of or e gra nte d ex pi re by th e te rm s of th e ad di tive 

am en dm en t on March 6, 1961. A gre at man y in du st ry pro gr am s wh ich are being 

co nd uc ted in ge ne ra l ha rm on y w ith th e ob jec tiv es of th e Food an d D ru g Ad minis tr ati o n ca nnot po ss ib ly be co mplete d by March 6, which is alm os t ujio n us. 

T he in du st ry , th er ef ore , may be face d w ith a co mplete ly ch ao tic si tu at io n un less 

th e po wer o f th e Fo od an d D ru g A dm in istrat io n to g ra n t su ch ex te ns io ns is 

ex tend ed pri or to March 6 of th is yea r. We under st an d th a t th e Fo od an d Drug 

A dm in is tr at io n is re qu es ting th a t th is powe r be gra n te d to it at le as t fo r 

ca se s in which bona fide te st in g pr og ra m s are un de rw ay an d in which it feels 

th a t th e in dust ry co nc erne d is co op erating.

The pu rp os e of th is l ett er is to ac quain t you w ith th e si tu ati on an d to stro ng ly 

ur ge you to su ppor t an im m ed ia te ex te ns io n of th e au 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 nt ex te nsi ons as her et of or e ou tli ne d. The re has been 

a g re at de al of c on ce rn th at be ca us e of th e co nfusion att en d an t upon th e ch an ge
FOOD ADD ITIVES 51

in ad m in is tr at io n, th is m att er wo uld be overl oo ked. How ev er, we be lie ve th a t it 

is complete ly nonpart is an an d we st ro ng ly ur ge th a t yo u ass is t in an y way 

yo u can.

Sinc erely yo urs,

R. U. P in e, Jr ., 

Res id en t Co un sel.

P. S.— Sin ce dic ta ti ng th e fo re go ing le tt er it has come to ou r att enti on th a t 

some people in ou r in d u st ry feel th a t th e po wer of FD A to g ra n t ex te ns io ns 

sh ou ld no t be re st ri cte d to si tu ati ons in which p art ic u la r te st in g pr og ra m s 

are pr es en tly un de rw ay . (1 ) We th in k th a t th is in dust ry po sitio n is soun d. 

W heth er FD A wo uld g ra n t an ex te ns io n in a p art ic u la r case would st il l be 

dis cr et io nar y an d FD A ne ed not g ra n t it. How ev er, it do es no t see m wise 

to so re st ri ct the po wer of FD A th a t it ca nnot under any circ um stan ce s g ra n t 

an ex tens io n in som e m er itorious or unus ual ca se in whi ch no te st in g pr ogra m 

is pr es en tly un de rw ay . How ev er, a dis put e ov er th e ex te n t of au th ori ty of FD A 

sh ou ld no t be perm itte d to bog down th e si tu ati on to such an exte nt th a t no 

le gi sl at io n is fo rthc om in g be fo re M arch 6. The d is pute is m in o r; som e le gi slat io n 

is in disp en sable.

(1 ) Th e FD A prop os ed bil l lim it s th e ri g h t of th e Sec re ta ry to gra nt exte nsion s to ca ses in which “h e fin ds (i ) th a t bona tide ac tion to det er m in e th e 

ap pl ic ab ility of su ch se ct ion 409 to su ch us e or uses, or to de ve lop the scientifi c 

d ata ne ce ss ar y fo r ac tion und er such section, w as comm enced by an in te re st ed 

pe rs on be fore M arch 6, 19G0, an d w as th ere aft er purs ue d w ith re as on ab le 

dilig en ce .”

(Whereupon, at 10:50 o’clock, the hearing was adjourned.)

o