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12 - ANIMAL DRUG AMENDMENTS OF 1967

____________________ ____________________________________________________ -

GO VE RN W N 1

Storage

H E A R I N G

W uniy,

SUBCOMMITTEE ON PUBLIC HI 

AND WEL FARE

[WfiMwes,

OF THE

COMMITTEE ON

INT ERSTA TE AND FOR EIGN COMMERCE 

HOUSE OF REPRESEN TA TIV ES

NIN ET IE TH CONG RESS

F IR S T SE SS IO N

ON

H .R . 3 6 3 9

A BIL L TO PR O TECT T H E PU B LIC H EA LTH BY AM EN DI NG 

T H E FE D E R A L FO OD , DR UG , AND CO SM ET IC AC T TO CONSO LI DATE CERTAIN PR OVIS IO NS ASS URIN G TH E SA FE TY 

AN D E F F E C T IV E N E SS OF NEW AN IM AL DR UG S, AN D FO R 

O TH ER PU RPO SES

(A nd Id enti cal B il ls )

OCT OB ER 3, 1067

D

w ------- (P

Serial No. 90-12

P ri n te d fo r th e us e o f t he 

Com m itt ee on In te rs ta te a nd Fore ig n C om me rce

85-419

U.S. GOVERNMENT PRINTING OFFIC E 

WASHINGTON : 1967

/

I
3 n l- ‘

-S'.-.y

CO MM ITT EE ON INTE RS TA TE AND FO RE IGN CO MM ERCE

HA RL EY O. ST AG GE RS , West Virginia, Chairman

SAM UEL N . FR IE D EL, Maryland 

TO RBERT II. MACDO NAL D, Massachusetts 

JOHN JAR MA N, Oklahoma

JOHN E. MOSS, California

JOHN D. DIN GEL L, Michigan

PA UL G. RO GE RS , Florida

HO RA CE R. KO RN EG AY , North Carolina 

LION EL VAN DEER LI N, California 

J. J. PI CKLE , Texas

FR ED B. RO ON EY , Pennsylvania 

JOHN M. MUR PH Y, New York 

DAVID E. SA TT ER FI EL D III , Virginia 

DA NI EL J. RONAN, Illinois 

BR OC K ADAMS, Washington 

RI CH AR D L. O TT IN GER , New York 

RAY BL AN TO N, Tennessee 

W. S. (BILL ) ST UC KE Y, J r., Georgia 

PETER N. KY RO S, Maine

W. E. 

Kenneth J

WILLIAM L. SPRIN G ER , Illinois 

SAMUEL L. D EV IN E, Ohio 

AN CH ER NEL SE N, Minnesota 

HA ST INGS KEIT H, Massachusetts 

GL EN N CU NN INGH AM , Neb raska 

JAMES T. BR OY HI LL , North Carolina 

JAMES HA RV EY , Michigan 

AL BE RT W. WATSON, South Carolina 

TIM LE E CARTE R, Kentucky 

G. RO BER T WATKINS, Pennsylvania 

DO NA LD G. BRO TZMAN, Colorado 

CL ARE NCE J. BROWN, Jr., Ohio 

DAN KU YK EN DA LL , Tennessee 

JO E SK UB ITZ, Kansas

Williamson, Clerk

Painter, As sistan t Clerk

Andrew Stevenson

Professional S taff

William J. Dixon

J ames M. Menger, Jr. R obert W. Lishma

S ubcom m it tee on P u blic H ea lth an d W e l fa r e

JOHN JARM AN , Oklahoma, Chairman

PA UL G. RO GE RS , Florid a AN .CIIER NE LS EN . Minnesota

DAVID E. SATT ERFI ELD II I, Virginia TIM LE E CARTE R, Ken tuck y

PE T E R N . KY RO S, Maine JOE SK UB ITZ, Kansas

11
C O N T E N T S

Pag e

Text of H.R. 3639................................................. .................... .................... 2

Report of—

Agriculture Department____________________________________ 11

Bureau of the Budget______________________________________ 10

Health, Education, and Welfare Department___________________ 11

Statem ent of—

Armstrong, Warren, representing American Feed Manufacturers

Association____________________________ . _______________ 53

Boyd, Lee II., director, feed control and nutrition, American Feed

Manufacturers Association________________________________ 53

Bray, Hon. William G., a Representative in Congress from the State

of Indiana______________________________________________ 17

Dwyer, Hon. Florence P., a Representative in Congress from the

State of New Jersey ______________________________________ 35

Ellenbogen, Theodore, Assistant General Counsel for Legislation,

Department of Health, Education, and Welfare_______________ 19

Frazier, Frank, executive vice president, National Broiler Council. _ 60

Goddard, Hon. James L., Commissioner, Food and Drug Administration, Department of Health, Education, and Welfare________ 19

Holt, John M., member, legislative committee, Animal Health

Institute_______________________________________________ 35, 45

Hull, Hon. W. IL, Jr., a Representative in Congress from the State

of Missouri_____________________________________________ 15

Kingma, Dr. Fred J., Deputy Director, Bureau of Veterinary Medicine,

Food and Drug Administration, Department of Health, Education, and Welfare________________________________________ 19

Landrum, Hon. Phil M., a Representative in Congress from the State

of Georgia_____________________________________________ 16

Nelsen, Hon. Ancher, a Representative in Congress from the State of

Minnesota______________________________________________ 13

Roehm, Dr. Luther S., president, Animal Health Ins titu te_______ 35

Schroeder, Dr. Robert J., president, American Veterinary Medical

Association_____________________________________________ 59

Stephens, Hon. Robert G., Jr., a Representative in Congress from

the State of Georgia_____________________________________ 17

Todd, Dr. Frank A., Washington representative, American Veterinary

Medical Association______________________________________ 59

Watts, Hon. John C., a Representative in Congress from the State

of Kentucky____________________________________________ 15

Additional material submitted for the record by—

Animal Health Institute:

Exhibit I—Statutory procedure for preclearance of human drugs. 47 

Exhibit II—Present regulatory clearance procedure for new

animal drug (non-food-producing animal)_________________ 47

Exhibit III—Present regulatory clearance procedure for new

animal drug (food-producing animal)____________________ 47

Exhibit IV—Present regulatory clearance procedure for certifiable animal antibiotic (non-food-producing animal)________ 48

Exhibit V—Present regulatory clearance procedure for certifiable

animal antibiotic (food-producing animal)________________ 48

Exhibit VI—Present regulatory clearance procedure for new

animal drug for feed (food-producing animal)_____________ 49

Exhibit VII—Present regulatory clearance procedure for certifiable antibiotic for animal feed (food-producing animal)____ 50

Exhibit VIII— Regulatory clearance procedures now applicable to

certain animal drugs__________________________________ 50

h i
IV CONTENTS

Additional material submitted for the record by—C ontinued

Animal Health Insti tute—Continued P a £

e

Exhibit IX—Proposed animal drug clearance under H.R . 3639_. 51

Purpose, summary, and analysis of II.R. 3639----------------------- 40

Statem ent of Earl L. Butz, dean of agriculture, Purdue University,

presented before the Subcommittee on Public Hea lth and 

Welfare, Jun e 13, 1966, on II.R . 7655_____________________ 39

Delm arva Pou ltry Industry, Inc., statem ent of William R. Stephens,

president__________________ - - ____________________________ 61

Georgia Poidtry Federation, statem ent of Abit Massey, execu tive, 

sec retary _________________________________________________ 63

Grain & Feed Dealers National Association, letter from Alvin E.

Oliver, executive vice preside nt______________________________ 65

Jarman, Hon. Joh n: Correspondence with Dr. Goddard re section 106

of H.R. 3639_____________________ ____________________ . . . . 23

Nelsen, Hon. Ancher: Correspondence with Food and Drug Administratio n requesting comment on certain dra ft amen dments to H.R .

3639___________________________. . . _______________________ 28,6 6

Pharmaceutical Manufacturers Association, letter from C. Joseph

Stetler, president__________________________________________ 65

Proprie tary Association, The, letter from James D. Cope, executive

vice president and treasu rer_________________________________ 64

Wisconsin Sta te Departm ent of Agriculture, letter from D. N.

McDowell, secretary of agr iculture___________________________ 64
J '

ANIMAL DRU G AME NDM ENTS OF 1967

TUESDAY, OCTOBER 3, 196 7

H ouse of R e pr e se n t a t iv e s,

S ubcom m it te e on P ublic H ea lt h an d W elfa r e

of t h e C om m it te e on I n ter sta te an d F o reig n C om m er ce,

Washington, D.C.

Th e subcom mittee met at 10 a.m., pu rsua nt to notice, in room 

2322, Ray bu rn Hou se Office B uilding, Hon . Jo hn Ja rm an (chairm an 

of the sub com mittee ) presiding.

Mr. J arm an. Th e sub comm itte e will please be in order.

Th e hea rings toda y are on H.R . 3639, which I introd uced, H.R. 

3640, and H.R . 3641, int roduced by our colleagues on the com mittee, 

Messrs. Rog ers and Nelsen, respec tively, as well as 11 by our colleagues in the House, Messrs. W atts, Hull, Andrews, Downing, 

La nd rum, Dwyer, Pa tten , Br ay, O’Nea l, Ste phens , and Ha rve y.

(The bills and sponsors referred to are as follows: H.R . 3639, 

Ja rm an , Oklah oma; H.R . 3640, Rogers, Flo rid a; H.R . 3641, Nelsen, 

Minn esota ; H.R . 3642, W atts, Ke ntu cky; H.R . 3643, Hull, Missouri; 

H .R . 5033, Andrews, Alabam a; H.R . 7165, Dow ning, Virginia; 

H.R . 8431, Landrum , Georgia; H.R . 8517, Dw yer, New Jersey ; 

H .R . 8722, Pa tte n, New Jerse y; H.R . 8741, Bra y, India na; H.R . 

8760, O’Neal, Geo rgia; H.R . 9002, Stephe ns, Georgia; H.R . 10159, 

Ha rvey, Michigan.)

Mr. J arm an. Un der existing law, the manufacturer of an animal 

feed which con tain s a dru g is tre ated as a new dru g ma nufac tur er, 

and is req uir ed to com ply wi th section 505 of the Foo d and Drug 

Act which relates to new drugs, and section 409 of the act, which 

relates to food add itives.

In addition , if the feed conta ins an antibiotic, the ma nufac tur er 

must com ply with the prov isions of section 507 of the Food and 

Dr ug A ct.

These provisions of law were initially designed from the point of 

view of their applicab ilit y to drugs, antibiotics, and food addit ive s 

prima rily for use by hum ans.

Th e pur pose of these bills is to consolidate int o one place in the 

law all of the cu rre nt provisions relati ng to dru gs for ad mi nis tra tio n 

to anim als, both dir ectly and in the ir feed or water.

Th e first con gressional action on this legislation co nsis ted of hearing s 

held during the 88th Congres s, bu t no furth er act ion was tak en during 

th at Congres s although conside rable prog ress was made in reconciling 

the different points of view concern ing the prop osed legislation.

This subcom mittee held hearing s on this legislation in Ju ne 1966, 

and the bill passed the House in the closing day s of the session wi tho ut 

a dissen ting vote. However, it was no t possible for act ion to be tak en 

by the S enate d uring th at session because of the shortness of time.

1
2 ANIMAL DRUG AMENDMENTS OF 196 7

The bill we have before us today is identical to the bill that passed 

the House last year, except that the effective date has been postponed 

from 6 months after the date of enactment to 12 months. In all other 

respects it is identical.

We hope to be able to complete House action on this bill expeditiously so that it can become law at an early date during this Congress.

At this point in the record there wiil be included the text of H.R . 

3639 and the agency reports thereon.

(The bill, H.R. 3639, and departm ental reports thereon follow:)

[II .R . 3639, 90th Cong., 1st sess.]

A BILL T o p rotect the public health by amending the Federal Food, Drug, a nd Cosmetic Act to consolidate certa in provisions assuring the safety and eflectiveness of new animal drugs, and for other purposes

Be it enacted by the Senate and House of Representatives of the United States of

America in Congress assembled, Th at this Act may be cited as the “Animal Drug 

Amendments of 1967.”

NEW ANIMAL DRUGS

S e c. 101. (a) Section 501(a) of the Federal Food, Drug, and Cosmetic Act, as 

amended, is amended by insertin g before the period at the end thereof a semicolon 

and the following: “or (5) if it is a new animal drug which is unsafe within the 

meaning of section 512; or (6) if it is an animal feed bearing or containing a new 

animal drug, and such animal feed is unsafe within the meaning of section 512”.

(b) Cha pter V of such Act is amended by adding at the end thereof the following: 

“ new a nim a l drugs

“ Se c. 512. (a)(1) A new animal drug shall, with respect to any particular use 

or inte nded use of such drug, be deemed unsafe for the purposes of section 501 

(a)(5) and section 402(a)(2)(D) unless—

“ (A) there is in effect an approval of an application filed pursuant to 

subsection (b) of this section with respect to such use or inte nded use of 

such drug,

“ (B) such drug, its labeling, and such use conform to such approved 

application, and

“ (C) in the case of a new animal drug subject to subsection (n) of this 

section and not exempted therefrom by regulations, it is from a batch with 

respect to which a certificate or release issued pursuant to subsection (n) is 

in effect with respect to such drug.

A new animal drug shall also be deemed unsafe for such purposes in the eve nt 

of removal from the establishm ent of a manufacturer, packer, or distributor of 

such drug for use in the man ufacture of anim al feed in any Sta te unless at the 

time of such removal such manufacturer, packer, or distribu tor has an unrevoked 

written statem ent from the consignee of such drug, or notice from the Secretary, 

to the effect tha t, with respect to the use of such drug in animal feed, such 

consignee—

“(i) is the holder of an approved application under subsection (m) of this 

section; or

“(ii) will, if the consignee is not a user of the drug, ship such drug only to 

a holder of an approved application under subsection (m) of this section.

“(2) An animal feed bearing or containing a new animal drug shall, with respect 

to any particular use or intended use of such animal feed, be deemed unsafe for 

the purposes of section 501(a)(6) unless—

“(A) there is in effect an approval of an application filed pursuant to 

subsection (b) of this section with respect to such drug, as used in such 

animal feed,

“(B) there is in effect an approval of an application filed pursuant to 

subsection (m)(l) of this section with respect to such animal feed, and

“(C) such animal feed, its labeling, and such use conform to the conditions 

and indications of use published pursua nt to subsection (i) of this section 

and to the application with respe ct thereto approved under subsection (m) 

of this section.
ANIMAL DRUG AMENDMENTS OF 19 6 7 3

“ (3) A new animal drug or an animal feed bearing or containing a new anima l 

drug shall not be deemed unsafe for the purposes of section 501(a) (5) or (6) if 

such article is fo r inves tigational use and conforms to the terms of an exemption 

in effect with respect thereto under section 512(j).

“ (b) Any person ma y file with the Secretary an application with respect to any 

intended use or uses of a new animal drug. Such person shall submit to the 

Secretary as a part of the application (1) full reports of investigations which 

have been made to show whether or not such drug is safe and effective for use; 

(2) a full list of the articles used as components of such drug; (3) a full statem ent 

of the composition of such drug; (4) a full description of the methods used in, 

and the facilities and controls used for, the manufacture, processing, and pack ing 

of such drug; (5) such samples of such drug and of the articles used as components 

thereof, of any animal feed for use in or on which such drug is intended, and of 

the edible portions or products (before or after slaughter) of animals to which 

such drug (directly or in or on animal feed) is intended to be administered, as 

the Secretary may require; (6) specimens of the labeling proposed to be used for 

such drug, or in case such drug is intended for use in animal feed, proposed labeling 

appropriate for such use, and specimens of the labeling for the drug to be manufactured, packed, or distributed by the appl ican t; (7) a description of practicable 

methods for determining the qua ntity, if any, of such drug in or on food, and 

any substance formed in or on food, because of its use; and (8) the proposed tolerance or withdrawal period or other use restrictions for such drug if any tolerance 

or withdrawal period or other use restrictions are required in order to assure tha t 

the proposed use of such drug will be safe.

“ (c) With in one hundred and eighty days after the filing of an application 

pursu ant to subsection (b), or such additional period as may be agreed upon by 

the Secretary and the applic ant, the Secretary shall either (1) issue an order 

approving the application if he then finds tha t none of the grounds for denying 

approval specified in subsection (d) applies, or (2) give the applic ant notice of an 

oppor tunity for a hearing before the Secretary under subsection (d) on the question 

whethe r such applica tion is approvable. If the applic ant elects to accep t the 

oppo rtunit y for a hearing by written request w ithin thir ty days after such notice, 

such hearing shall commence not more than ninety days after the expiration of 

such thirty days unless the Secretary and the applic ant otherwise agree. Any such 

hearing shall thereafter be conducted on an expedited basis and the Secr etary’s 

order thereon shall be issued within ninety days after the date fixed by the 

Secreta ry for filing final briefs.

“ (d) (1) If the Secreta ry finds, after due notice to the applic ant in accordance 

with subsection (c) and givin g him an opportunity for a hearing, in accordance 

with said subsection, tha t—

“ (A) the investigation s, reports of which are required to be submitted to 

the Secretary pursuant to subsection (b), do not include adequate tests by 

all methods reasonably applicable to show whether or not such drug is safe 

for use under the conditions prescribed, recommended, or suggested in the 

proposed labeling thereof;

“ (B) the results of such tests show tha t such drug is unsafe for use under 

such conditions or do not show tha t such drug is safe for use under such 

conditions;

“ (C) the methods used in, and the facilities and controls used for, the 

manufacture, processing, and packin g of such drug are inadequate to preserve 

its iden tity, strength , qua lity , and puri ty;

“ (D) upon the basis of the informatio n submi tted to him as part of the 

applica tion, or upon the basis of any other informatio n before him with 

respect to such drug, he has insufficient informa tion to determine whether 

such drug is safe for use under such conditions;

“ (E) evaluated on the basis of the informatio n submitted to him as part of 

the application and any other information before him with respect to such 

drug, there is a lack of substantial evidence tha t the drug will have the effect 

it purports or is represented to have under the conditions of use prescribed, 

recommended, or suggested in the proposed labeling thereof;

“ (F) upon the basis of the information submi tted to him as part of the 

application or any other information before him with respect to such drug, 

the tolerance limitation proposed, if any, exceeds tha t reasonably required 

to accomplish the phys ical or other technical effect for which the drug is 

intended;

“ (G) based on a fair evalua tion of all material facts , such labeling is false 

or misleading in any parti cular ; or
4 AN IM AL DRUG AM EN DM EN TS OF 1967

“ (H) such drug induces cancer when ingested by man or animal or, after 

tests which are appropria te for the evalua tion of the safety of such drug, 

induces cancer in man or anim al, except tha t the foregoing provisions of this 

subparagraph shall not app ly with respect to such drug if the Secretary finds 

tha t, under the conditions of use specified in proposed labeling a nd reasonably 

certain to be followed in practice (i) such drug will not adversely affect the 

animals for which it is intended, and (ii) no residue of such drug will be found 

(by methods of examin ation prescribed or approved by the Secretary by 

regulations, which regulations shall not be subject to subsections (c), (d), 

and (h)), in any edible portion of such animals after slaughte r or in any food 

yielded by or derived from the livin g animals;

he shall issue an order refusing to approve the application. If, after such notice 

and oppor tunity for hearing, the Secreta ry finds tha t subparagraphs (A) through 

(H) do not apply , he shall issue a n order a pproving the applicatio n.

“ (2) In determining whether such drug is safe for use under the conditions 

prescribed, recommended, or suggested in the proposed labeling thereof, the 

Secre tary shall consider, among other relevant factors, (A) the probable consumption of such drug and of any substance formed in or on food because of the use 

of such drug, (B) the cumu lative effect on man or anima l of such drug, takin g 

into accou nt any chemically or pharmacologic ally related substa nce, (C) safety 

factor s which in the opinion of experts, qualified by scientific trainin g and experience to evalu ate the safety of such drugs, are appropriate for the use of 

anim al experimentation data, and (D) whether the conditions of use prescribed, 

recommended, or suggested in the proposed labeling are reasonably certain to 

be followed in practice. Any order issued under this subsection refusing to approve an application shall state the findings upon which it is based.

“ (3) As used in this subsection and subsection (e), the term ‘substantia l 

evidence’ means evidence consisting of adequate and well-controlled inves tigations, includ ing field inves tigation, by experts qualified by scientific trainin g and 

experience to evalu ate the effectiveness of the drug invol ved, on the basis of 

which it could fairly and reasonably be concluded by such experts tha t the drug 

will have the effect it purports or is represented to have under the conditions of 

use prescribed, recommended, or suggested in the labeling or proposed labeling 

thereof.

“ (e)(1) The Secreta ry shall, after due notice and oppo rtunity for hearing to 

the a pplic ant, issue an order withdra wing approval of an applic ation filed pursuant 

to subsection (b) with respect to any new a nimal drug if the Secretary finds—-

“ (A) that experience or scientific data show tha t such drug is unsafe for 

use under the conditions of use upon the basis of which the applic ation was 

approve d;

“ (B) that new evidence not contained in such application or not available 

to the Secretary until after such applica tion was approved, or tests by new 

methods, or tests by methods not deemed reasonably applicable when such 

application was approved, evaluate d together with the evidence available to 

the Secretary when the applic ation was approved, shows that such drug is 

not shown to be safe for use under the conditions of use upon the basis of 

which the application was approved or tha t subparagraph (H) of paragraph 

(1) of subsection (d) applies to such drug;

“ (C) on the basis of new information before him with respect to such 

drug, evalua ted together with the e vidence available to him when the application was approved, that there is a lack of substantial evidence tha t such 

drug will have the effect it purports or is represented to have under the 

conditions of use prescribed, recommended, or suggested in the labeling 

there of;

“ (D) that the applica tion contains any untrue statem ent of a material 

fac t; or

“ (E) tha t the applic ant has made any changes from the stand point of 

safety or effectiveness beyond the variation s provided for in the application 

unless he has supplemented the application by filing with the Secretary adequate informatio n respecting all such changes and unless there is in effect 

an approval of the supplemental application. The supplemental applic ation 

shall be treated in the same manner as the original application.

If the Secretary (or in his absence the officer actin g as Secretary) finds tha t there 

is an imminent hazard to the health of man or of the animals for which such 

drug is intended, he may suspend the approval of such application immediately, 

and give the applic ant prompt notice of his action and afford the appl icant the
ANIMAL DRUG AMENDMENTS OF 19 67 5

opport unit y for an ex pe di te d he ar in g un de r th is su bs ec tio n; b u t th e auth ori ty 

co nf er re d by th is se nt en ce to su sp en d th e ap pr ov al of an ap pl ic at io n sh all not be 

de lega ted.

“ (2) The Se cr et ar y m ay als o, aft er du e no tic e and opport unit y for he ar in g to 

th e ap pl ic an t, issu e an or de r w ith dr aw in g th e ap pro val of an ap pl ic at io n w ith 

re sp ec t to an y new an im al dru g un de r th is se ction if th e Sec re ta ry fin ds—

“ (A) th a t th e ap pli cant ha s fai led to es ta bl ish a sy st em for m ai nt ai ni ng 

recpiired reco rds, or has re pe at ed ly or de libe ra te ly fai led to m ai nt ai n su ch 

reco rd s or to mak e re qui re d re po rts in ac co rd an ce w ith a regu la tio n or or de r 

un de r su bs ec tio n (1), or th e ap plica nt ha s refu se d to pe rm it acces s to, or 

co py ing or ve rific ation of, su ch reco rds as re qu ired by par ag ra ph (2) of su ch 

su bs ec tion;

“ (B) th a t on th e ba sis of ne w in fo rm at io n be fore him, ev al uate d to get her 

w ith t he evide nc e before him w he n th e ap pl ic at io n was a pp ro ve d, th e m et ho ds 

used in, or th e facilit ies an d co ntro ls us ed for, th e m an uf ac tu re , pro cessing , 

(and pa ck ing of su ch dru g are in ad eq uate to assu re an d pr es erve its id en tity , 

st re ngth , qu al ity, and p uri ty a nd w ere no t mad e ad equate w ith in a rea so na ble 

tim e af te r re ce ip t of w ri tt en no tic e fro m th e Sec re ta ry sp ec ify ing th e m att er 

co mplain ed of; or

“ (C) th a t on th e ba sis of ne w in fo rm at io n be fore him, eval uate d to get her 

w ith th e e vide nc e be fore h im w hen th e ap pl ic at io n wa s ap pr ov ed , th e lab eling 

of su ch drug , ba se d on a fair ev al ua tion of all m at er ia l facts, is fal se or mi slead in g in an y par ti cula r an d was no t co rrec ted w ith in a re as on ab le tim e af te r 

re ce ip t of w ritten no tic e from t he Sec re ta ry sp ec ify ing th e m att er co mpl aine d 

of.

“ (3) An y or de r un der th is su bs ec tio n sh all st ate th e fin ding s up on which it is 

ba sed.

“ (f) W he ne ve r th e Se cr et ar y fin ds th a t th e f ac ts so re qu ire, he sh all re vo ke an y 

pr ev io us or de r unde r su bs ec tio n (d) , (e), or (m) refusin g, w ith dr aw in g, or s usp en din g ap pr ov al of an ap pl ic at io n an d sha ll ap pr ov e su ch a pplica tion or r ei nst ate s uc h 

ap pr ov al , as may be ap pr opr ia te .

“ (g) Orders of t h e S ec re ta ry is su ed u nd er th is sec tio n (o th er th an o rders iss uing , 

am en di ng , or re pe al ing re gu latio ns ) sh all be se rv ed (1) in pe rson by an y officer or 

em pl oy ee of th e depart m ent de sign ated by th e Se cr et ar y or (2) by mailin g th e 

or de r by re gi ster ed mail or by ce rtifie d mail ad dr es se d to t he ap plica nt or res po nd ­

en t a t his la st kn ow n ad dr es s in th e reco rd s of th e Se cr et ar y.

“ (h) An ap pe al m ay be ta ken by th e ap plica nt from an or de r of th e Sec re ta ry 

re fu sing or w ithd ra w in g ap pro va l of an ap pl ic at io n filed und er su bs ec tio n (b) or 

(m) of th is se ction. The pr ov isions of su bs ec tio n (h) of section 505 of th is Ac t 

sh al l go ve rn an y su ch ap pe al .

“ (i) W he n a ne w an im al dru g ap pl ic at io n file d p urs uant to su bs ec tio n (b) is 

ap pr ov ed , th e Sec re ta ry sh all by no tic e, wh ich up on pub lica tion sh all be eff ectiv e 

as a re gu la tion , pu bl ish in th e Fe de ra l Reg iste r th e na me and ad dr es s of th e ap ­

pli ca nt and th e co nd iti on s and in di ca tion s of use of th e new an im al dr ug co ve red 

by su ch ap pl ic at io n, in cl ud ing an y to le ra nc e an d w ithd ra w al pe riod or oth er use 

re st ri ct io ns an d, if su ch new an im al dr ug is in te nded for use in an im al feed, ap ­

pro pri ate pu rp os es and co nd itio ns of use (inc luding s pe cial labe lin g requ ire m en ts) 

ap pl ic ab le to an y an im al fee d for use in which su ch dr ug is ap pr ov ed , an d su ch 

ot her in fo rm at io n, up on th e ba sis of wh ich su ch ap pl ic at io n wa s ap pr ov ed , as th e 

Sec re ta ry de em s ne ce ss ary to as su re th e safe and eff ectiv e use of su ch drug . Upo n 

w ithdra w al of appr ov al of su ch ne w an im al dru g ap pl ic at io n or up on its su sp en ­

sio n, th e Se cr et ar y sh all fo rt hw ith re vo ke or su sp en d, as th e cas e may be, th e 

re gul at io n pu blishe d purs uant to th is su bs ec tio n (i) in so far as it is ba sed on the 

app ro va l of such ap pl ic at io n.

“ (j) To th e exte nt co ns is te nt w ith th e pu bl ic he al th , th e Sec re ta ry shall prom ul ga te re gu la tion s for e xe m pt in g fro m th e op er at io n of th is section new an im al 

drug s, an d an im al fee ds be ar in g or co nt ai ni ng new an im al drug s, in te nd ed sol ely 

fo r in ve stig at io na l use by ex pe rts qu ali fie d by scientifi c tr ain in g a nd experie nce to 

in ve st ig at e th e sa fe ty an d effecti ve ne ss of an im al dr ug s. Su ch regu la tio ns may , in 

th e disc retio n of th e Sec re ta ry , am on g ot he r co nd itio ns re la ting to th e pro te ct io n 

of th e pu blic he alth , pr ov id e for co nd iti on in g su ch ex em pt io n up on th e es ta bl ishm en t and m ai nt en an ce of su ch reco rd s, and th e m ak in g of su ch re po rts to th e 

Sec re ta ry , by th e m anufa ct ure r or th e sp on so r of th e in ves tigat io n of such artic le , 

of d a ta (in clud ing b u t not lim ited to an al yt ic al re port s by inve stig ator s) ob ta in ed 

as a re su lt of su ch in ve st ig at io na l use of su ch ar ticl e, as th e Se cr et ar y fin ds will 

en ab le him to eval uate th e sa fe ty and effecti veness of su ch ar ticl e in th e ev en t of 

th e filing of an a pp lica tion p urs uant to t hi s se ction. Su ch re gu la tion s, am on g oth er

85 -4 1 9— 67------ 2
6 ANIMAL DRUG AMENDMENTS OF 19 67

things, shall set forth the conditions (if any) upon which animals treated with 

such articles, and any products of such animals (before or aft er slaughter), may be 

marketed for food use.

“ (k) While approval of an application for a new animal drug is effective, a 

food shall not, by reason of bearing or contain ing such drug or any substance 

formed in or on the food because of its use in accordance with such application 

(including the conditions and indications of use prescribed pursuant to subsection 

(i)), be considered a dulterated within the meaning of clause (1) of section 402(a).

“ (1) (1) In the case of any new anima l drug for which an approval of an appli cation filed pursuant to subsection (b) is in effect, the applic ant shall establish and 

maintain such records, and make such reports to the Secretary, of data relating 

to experience and other data or inform ation, received or otherwise obtained by 

such applicant with respect to such drug, or w ith respect to animal feeds bearing 

or contain ing such drug, as the Secretary may by general regulation, or b y order 

with respect to such applic ation, prescribe on the basis of a finding tha t such 

records and reports are necessary in order to enable the Secretary to determine, or 

facil itate a determination, whether there is or may be ground for invok ing subsection (e) or subsection (m) (4) of this section. Such regulation or order shall 

provide, where the Secretary deems it to be appropriate, for the examin ation, 

upon request, by the persons to whom such regulation or order is applicab le, of 

similar informatio n received or otherwise obtained by the Secretary.

“ (2) Eve ry person required under this subsection to maintain records, and 

every person in charge or custo dy thereof, shall, upon request of an officer or 

employee designated by the Secre tary, permit such officer or employee at all 

reasonable times to have access to and copy and veri fy such records.

“ (m)(l) Any person may file with the Secreta ry an application with respect to 

any intended use or uses of an animal feed bearing or conta ining a new animal 

drug. Such person shall submi t to the Secretary as p art of the application (A) a full 

statement of the composition of such animal feed, (B) an identification of the regulation or regulations (relating to the new an imal drug or drugs to be used in such 

feed), published pursuant to subsection (i), on which he relies as a basis for 

appro val of his application with respect to the use of such drug in such feed, (C) a full description of the methods used in, and the facilitie s and controls used for, the 

manu facture, processing, and pack ing of such animal feed, (D) specimens of the 

labeling proposed to be used fo r such animal feed, and (E) if so requested by the 

Secretary, samples of such anima l feed or components thereof.

“ (2) Within ninet y days after the filing of an application pursuant to subsection 

(m )(l ), or such additional period as m ay be agreed upon by t he Secretary and the 

applican t, the Secretary shall either (A) issue an order appro ving the a pplication if 

he then finds that none of the grounds for denying ap proval specified in p aragraph 

(3) applies, or (B) give the appl icant notice of an appo rtun ity for a hearing before 

the Secreta ry under paragraph (3) on the question whether such application is 

appro vable. The procedure governin g such a hearing shall be the procedure set 

forth in the last two sentences of subsection (c).

“ (3) If the Secretary, after due notice to the appli cant in accordance with 

paragraph (2) and giving him an oppor tunity for a hearing in accordance with such 

parag raph, finds, on the basis of informatio n subm itted to him as part of the 

application or on the basis of any other information before him—

“ (A) that there is not in effect a regulation under subsection (i) (identified 

in such application) on the basis of which such application may be ap pro ved ;

“ (B) that such animal feed (including the proposed use of a ny new an imal 

drug therein or thereon) does not conform to an applicable regulation published pursuant to subsection (i) referred to in the applica tion, or tha t the 

purposes and conditions of indicatio ns of use prescribed, recommended, or 

suggested in the labeling of such feed do not conform to the applicable 

purposes and conditions or indications of use (including warnings) published 

pursuant to subsection (i) or such labeling omits or fails to conform to other 

applicable informa tion published pursuant to subsection (i);

“ (C) tha t the methods used in, and the facilities and controls used for, 

the manufac ture, processing, and packin g of such animal feed are inadequate 

to preserve the iden tity, streng th, qua lity, and purit y of the new animal 

drug therein; or

“ (D) that , based on a fair evaluation of all material facts, such labeling 

is false or misleading in any particu lar;

he shall issue an order refusing to approve the application. If, after such notice 

and opportunity for hearing, the Secretary finds that subparagraphs (A) through 

(D) do not apply , he shall issue an order approving the application. An order
ANIMAL DRUG AMENDMENTS OF 19 67 7

under this subsection approving an application with respect to an animal feed 

bearing or containing a new anima l drug shall be effective only while there is in 

effect a regulation pursuant to subsection (i), on the basis of which such appli cation (or a supplement thereto) was approved, relating to the use of such drug in 

or on such feed.

“ (4)(A) The Secretary shall, after due notice and oppor tunity for hearing to 

the appli cant, issue an order with drawing approval of an application with respect 

to any animal feed under this subsection if the Secreta ry finds—

“ (i) that the application contains any untrue statement of a mate rial 

fac t; or

“ (ii) tha t the appli cant has made any changes from the stand point of 

safety or effectiveness beyond the varia tions provided for in the application 

unless he has supplem ented the application by filing with the Secretary adequate inform ation respecting all such changes and unless there is in effect 

an approval of the supple mental applic ation. The supplementol application 

shall be t reated in the same manner as the original applic ation.

If the Secretary (or in his absence the officer acting as Sec retary) finds th at there is 

an imminent hazard to the health of man or of the animals for which such anim al 

feed is intended, he may suspend the approval of such appli catio n imm ediately, 

and give the appli cant prompt notice of his action and afford the appl icant the 

opportunity for an expedited hearing under this subsec tion; but the auth ority 

conferred by this sentence shall not be delegated.

“ (B) The S ecretary may also, after due notice and oppor tunity for hearing to the 

appl icant, issue an order withdraw ing the appr oval of an application with respect 

to any animal feed under this subsection if the Secretary finds—

“ (i) tha t the appli cant has failed to establish a system for main tainin g required records, or has repeated ly or delibera tely failed to maintain such records or to make required reports in accordan ce with a regulation or order 

under paragraph (5)(A) of this subsection, or the appl icant has refused to 

permit access to, or copying or verification of, such records as required by 

subparagraph (B) of such parag raph;

“ (ii) tha t on the basis of new informa tion before him, evalu ated together 

with the evidence before him when such application was approved, the 

methods used in, or the facili ties and controls used for, the manufacture, 

processing, and pack ing of such animal feed are inadequate t o assure and preserve the iden tity, streng th, qua lity , and purity of the new anima l drug therein, and were not made adequ ate within a reasonable time after receipt of 

written notice from the Secre tary, speci fying the matter complained of; or

“ (iii) tha t on the basis of new inform ation before him, evalu ated together 

with the evidence before him when the a pplication was approved, the labeling 

of such animal feed, based on a fair evaluation of all material facts , is false or 

misleading in any parti cular and was not corrected within a reasonable time 

after receipt of written notice from the Secreta ry specifying the matte r complained of.

“ (C) An y order under paragraph (4) of this subsection shall state the findings 

upon which it is based.

“ (5) In the case of any anima l feed for which an approval of an application 

filed pursuant to this subsection is in effect—

“ (A) the app licant shall establish and main tain such records, and make 

such reports to the Secre tary, or (at the option of t he Secretary) to the appropriate person or persons holdin g an approved applic ation filed under subsection (b), as the Secretary may by general regulation, or by order with 

respect to such appli cation, prescribe on the basis of a finding tha t such 

records and reports are necessary in order to enable the Secretary to determine, or facil itate a determ ination, w’hether there is or may be ground 

for invok ing subsection (e) or paragraph (4) of this subsection.

“ (B) every person required under this subsection to maintain records, and 

every person in charge or custod y thereof, shall, upon request of an officer or 

employee designated by the Secr etary, permit such officer or employee at all 

reasonable times t o have access to and copy and verify such records.

“ (n)( l) The Secretary, pursuant to regulations promulgated by him, shall 

provide for the certific ation of batche s of a new an imal drug composed wholly or 

partl y of any kind of penicill in, strep tomycin, chlorte tracycline, chloramphenicol, 

or bacitracin , or any deriv ative t hereof. A batch of any such drug shall be certified 

if an appro val of an application filed pursuant to subsection (b) is effective with 

respect to such drug and such drug has the characteristics of identity and such 

batch has the characteristics of stren gth, qua lity, and purity upon the basis of
8 ANIMAL DRUG AMEN DMENTS OF 19 67

which the application was approved, but shall not otherwise be certified. Prior 

to the effective date of such regulations the Secreta ry, in lieu of certification, shall 

issue a release for any batch which, in his jud gme nt, may be released without risk 

as to the safety and efficacy of its use. Such release shall prescribe the date of its 

expiration and other conditions under which it shall cease t o be effective as to such 

batch and as to portions thereof.

“ (2) Regu lations providing for such certifications shall contain such provisions 

as are necessary to carry out the purposes of this subsection, including provisions 

prescribing—

“ (A) tests and methods of assay to determine compliance with applicable 

standa rds of identity and of st rengt h, quality, and puri ty;

“ (B) effective periods for certificates, and other conditions under which 

they shall cease to be effective as to certified batches and as to portions 

thereof;

‘‘ (C) administration and procedure; and

“ (D) such fees, specified in such regulations, as are necessary to provide, 

equip, and maintain an adequate certification service.

Such regulations shall prescribe only such tests and methods of assay as will 

provide for certification or rejection within the shortest time consistent with the 

purposes of this subsection.

“ (3) Whenever, in the judg men t of the Secreta ry, the requirements of this subsection with respect to any drug or class of drugs are not necessary to insure t hat 

such drug conforms to the standards of identity, strength, qua lity , and purity 

applicable thereto under paragraph (1) of this subsection, the Secreta ry shall 

promulgate regulations exemptin g such drug or class of drugs from such requirements. The provisions of subsection (c) of section 507 of this Ac t (other than the 

first sentence thereof) shall apply under this paragraph.

“ (4) The Secretary shall promulgate regulations exempting from any requirement of this subsection—

“ (A) drugs which are to be stored, processed, labeled, or repacked at 

establishments other than those where manufactured , on condition tha t such 

drugs comply with all such requirements upon removal from such establishments; and

“ (B) drugs which conform to applicable standards of iden tity, stren gth, 

quality, and purity prescribed pursuant to this subsection and are intended 

for use in manufacturing other drugs.

“ (5) On petition of any interested person for the issuance, amendment, or 

repeal of any regulation contemplated by this subsection, the procedure shall be 

in accordance with subsection (f) of section 507 of this Ac t.

“ (6) Where any drug is su bject to this subsection and not exempt ed therefrom 

by regulations, the compliance of such drug with sections 501(b) and 502(g) shall 

be determined by the applica tion of the standards of str ength, qualit y, and purity 

applicab le under paragraph (1) of this subsection, the tests and methods of assay 

applicable under provisions of regulations referred to in paragraph (2) (A) of this 

subsection, and the requirements of pack agin g and labeling on the basis of which 

the appl ication with respect to such drug filed under sub section (b) of this section 

was approve d.”

D E F IN IT IO N S

Se c. 102. Section 201 of the Federal Food, Dru g, and Cosm etic Act, as 

amended, is amended by—

(a) inserting “ (except a new animal drug or an anima l feed bearing or 

conta ining a new animal drug)” after “ Any drug” in subparagraph (1) of 

paragraph (p) ;

(b) inserting “ (except a new anima l drug or an animal feed bearing or 

containin g a new animal drug)” after “ Any drug” in subparagraph (2) of 

paragraph (p);

(c) striking out the period at the end of subparagrap h (4) of paragraph (s) 

and inserting in lieu thereof “ ; or” , and by adding a new subparagraph (5) 

to read as follows: “ (5) a new anima l drug.” ;

(d) inserting “ , 512,” after “ 400” in paragraph (u); and

(e) adding at the end of such section the following new paragrap hs:

“ (w) The term ‘new an imal drug’ means any drug intended for use for animals

other than man, including any drug intended for use in animal feed but not including such animal feed,—

“ (1) the composition of which is such tha t such drug is not generally 

recognized, among experts qualified by scientific trainin g and experience to
ANIMAL DRUG AMENDMENTS OF 19 67 9

ev al uate th e sa fe ty and eff ec tiv en ess of an im al dr ug s, as safe an d eff ective 

for use unde r th e co nd iti on s pr es cr ibed , reco m men de d, or su gg es ted in the 

labe lin g th er eo f; ex ce pt th a t su ch a dr ug not so reco gn ized sh all no t be 

de em ed to be a ‘new an im al dru g’ if a t an y tim e prior to J une 25, 1938, it was 

su bje ct to th e Fo od and D ru g Act of Ju ne 30, 1906, as am en de d, an d if a t 

su ch tim e its labe lin g co nt ai ne d th e same re pre se nta tions co nc erning th e 

co nd iti on s of its use; or

“ (2) th e co mpo sitio n of which is s uc h th a t su ch dr ug , as a re su lt of in ve stiga tio ns to d eter m in e its sa fe ty a nd e ffe cti ve ne ss fo r use un de r su ch c on ditio ns , 

ha s become so reco gn ized b u t whic h ha s no t, ot he rw ise th an in su ch in ve stiga tio ns , been us ed to a m at er ia l exte nt or for a m at er ia l tim e un de r su ch 

co nd iti on s; or

“ (3) wh ich dr ug is co mpo sed who lly or p art ly of any kin d of pe nicillin, 

st re pt om yc in , ch lo rtet ra cy cl in e, ch lora mph en icol, or ba ci trac in , or an y 

de riva tive thereo f, ex ce pt whe n th er e is in eff ect a publ is he d or de r of th e 

Sec re ta ry de claring su ch dr ug not to be a new an im al dru g on th e gr ou nd s 

th a t (A) th e re quir em en t of ce rtificatio n of ba tc he s of su ch dr ug , as pr ov id ed 

fo r in se ct ion 51 2(n), is n o t ne ce ss ar y to insu re th a t th e ob je ct iv es spe cified 

in para gra ph (3) th er eo f are ac hi ev ed an d (B) th a t nei th er su b p ara g ra p h /1 ) 

no r (2) of th is p ar agra ph (w) ap pl ie s to suc h drug .

“ (x) The te rm ‘ani m al f ee d’, as us ed in par ag ra ph (w) of th is se ction, in 'sec tio n 

512, and in p rovisio ns of th is Ac t re fe rrin g to suc h para gra ph or sec tio n, m ea ns an 

ar tic le which is in te nd ed fo r use for foo d fo r an im als oth er th an m an an d wh ich is 

in te nded f or use as a su bst anti al so ur ce of nutr ie nts in th e die t of th e an im al , an d 

is not lim ited to a m ix tu re in te nde d to be th e sole ra ti on of th e anim al.”

P R O H IB IT E D ACT S AN D P E N A L T IE S

Sec . 103. Se cti on 301 of th e Fed er al Fo od , D ru g, an d Cos metic Ac t, as 

am en de d, is am en de d by —

(1) st riki ng out “or” be fore “ 507,” an d in se rtin g “, or 512 (j) , (1), or (m )” 

aft er “ 507 (d) or (g )” in par agra ph (e), an d

(2) ad di ng “51 2,” aft er “50 7,” in par ag ra ph (j) .

A NIM A L D RUG S IN F E E D S AND R E S ID U E S T H E R E O F IN O T H E R FO OD

Sec. 104. Se ctio n 402 of th e Fed er al Fo od , Dru g, an d Cos metic Ac t, ag 

am en de d, is am en de d by —

(1) st riki ng out th e w ord “ o r” before “ (ii i)” in cla use (A) of su bpar ag ra ph 

(2) of par agra ph (a) an d in se rtin g “ ; or (iv) a new an im al d ru g” aft er th e 

words “ color ad d it iv e” th ere in ; an d

(2) ad di ng be fore th e semico lon following “ co m m od ity” a t th e en d of th e 

pr ov iso to cla use (C) of su bpara gra ph (2) of par agra ph (a) th e follo wing: 

“ ; or (D) if it is, or it be ar s or co nt ai ns , a new an im al dru g (or co nv ersio n 

pro duct thereo f) which is un sa fe w ithin th e m ea ni ng of se ct io n 512” .

A N T IB IO T IC D RUG S FO R ANIM A LS

Sec . 105. (a) Se ction 502 of th e Fe de ra l Fo od , Dru g, an d Co sm etic Ac t, as 

am en de d, is am en de d by in se rtin g “ (exc ep t a dr ug fo r use in an im als oth er th an 

m an )” aft er “re pre se nte d as a dru g” in para gra ph (1).

(b) Se ctio n 507 of su ch Act is am en de d by in se rtin g “ (exc ep t dr ug s for use in 

an im al s oth er th an m an )” aft er “ dru gs” in th e firs t se nt en ce of su bs ec tio n (a) .

A N IM A L D RUG S FO R E X P O R T

Sec . 106. Se ction 80 1(d ) of th e Fe de ra l Fo od , Dru g, an d Co sm etic Ac t, as 

am en de d, is a m en de d by ad di ng a t th e en d th er eo f th e follo wing: “ N ot hi ng in th is 

su bs ec tio n sh all au th ori ze th e ex port ati on of an y new an im al drug , or an an im al 

feed be ar in g or co nt ai ni ng a new an im al dr ug whic h is un sa fe w ith in th e m ea ni ng 

of se ct ion 512 of th is A ct .”

A M EN D M EN T W IT H R E S P E C T TO V IR U S , SER U M , T O X IN , AN D A NA LO GOUS PR OD U CTS 

AC TS

Sec. 107. Se ction 902 (c) of th e Fed er al Fo od , D ru g, and Co sm etic Act is 

am en de d by st riki ng out “th e viru s, seru m, an d toxi n Act of Ju ly 1, 1902 (U .S .C ., 

1934 ed ., ti tl e 42, ch ap . 4); ” and in se rtin g in lie u th er eo f th e follo wi ng : “se ct io n
10 ANIMAL DRUG AMENDMENTS OF 19 67

351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to ma n); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved 

Marc h 4, 1913 (37 Stat. 832-833);” .

E F F E C T IV E DATE AN D TR A N SIT IO N A L PR O V IS IO N S

Sec. 108. (a) Except as otherwise provided in this section, the amendments 

made by the foregoing sections shall take effect on the first day of the thirteenth 

calendar month which begins after the date of ena ctment of th is Act.

(b)(1) As used in this subsection, the term “effective date” means the effective 

date specified in subsection (a) of this section; the term “basic Act” means the 

Federal Food, Drug, and Cosmetic Act; and other terms used both in this section 

and the basic Act shall have the same meaning as they have, or had, at the time 

referred to in the context, under the basic Act.

(2) Any approval, prior to the effective date, of a new animal drug or of an 

animal feed bearing or containing a new anim al drug, whether granted by approval 

of a new-drug application, master file, antibiotic regulation, or food additive regulation, shall continue in effect, and shall be subject to change in accordance with 

the provisions of the basic Act as amended by this Act.

(3) In the case of any drug (other than a drug subject to section 512(n) of th e 

basic Act as amended by this Act) intended for use in animals other tha n man 

which, on October 9, 1962, (A) was commercially used or sold in the United States, 

(B) was not a new drug as defined by section 201 (p) of the basic Act as then in 

force, an d (C) was not covered by an effective app lication under section 505 of th at 

Act, the words “effectiveness” and “effective” containe d in section 201 (w) as 

added by this Act to the basic Act shall not apply to such drug when intended 

solely for use under conditions prescribed, recommended, or suggested in labeling 

with respect to such drug on that day.

(4) Regulations providing for fees (and a dvance deposits to cover fees) which on 

the day preceding the effective d ate applicable under subsection (a) of this section 

were in effect pursu ant to section 507 of the basic Act shall, except as the Secretary 

may otherwise prescribe, be deemed to apply also under section 512(n) of the basic 

Act, and appropriations of fees (and of advance deposits to cover fees) available for 

the purposes specified in such section 507 as in effect prior to the effective date 

shall also be available for the purposes specified in section 512(n), including preparatory work or proceedings prior to th at date.

E xecutive Office of the P resident,

Bureau of the Budget,

Washington, D.C., October 2, 1967. Hon. Harley O. Staggers,

Chairman, Committee on Interstate an d Foreign Commerce, House of Representatives,

Raybu rn House Office Buildin g, Washington, D.C.

Dear Mr. Chairman: This is in response to your request for a repo rt on II.R. 

3639, a bill “To protect the public hea lth by amending the Federal Food, Drug, 

and Cosmetic Act to consolidate certain provisions assuring the safety and effectiveness of new animal drugs, and for other purposes.”

The consolidating provisions in this bill, to be known as the “ Animal Drug 

Amendments of 1967,” have been long and carefully considered by the Congress. 

They were first introduce d in th e 87th Congress. The present bill, with the exception of the period between enactm ent and effective date, is identical to H.R . 

16474, which was passed by the House of Representatives in the 89th Congress.

We agree with the views of the Depar tment of Health, Education, and Welfare 

which were furnished your Committe e in a report by the Under Secretary. This 

bill will significantly improve the legal framework within which the Food and 

Drug Administration will function in assuring the safety and effectiveness of 

new animal drugs.

We recommend enactment of the bill.

Sincerely yours,

J ames M. Frey,

Acting A ssista nt Director fo r Legislative Reference.
ANIMAL DRUG AMENDMENTS OF 19 67 11

Department of Health, Education, and Welfar e,

Washington, D.C., Ju ly 10, 1967.

Hon. Harley O. Staggers,

Chairman, House Interstate and Foreign Commerce Committee, House of Repre sentatives, Washington, D.C.

Dear Mr. Chairman: This is in response to your request of March 13, 1967, 

for a report on H.R . 3639, a bill “to protect the public health by amending the 

Federal Food, Drug, and Cosmetic Act to consolidate certain provisions assuring 

the safety and effectiveness of new animal drugs, and for other purposes.” The 

bill is known as t he “Animal Drug Amendments of 1967.”

This bill is identical to H .ll. 16474, repo rted by your Committee and passed 

by the House of Representatives in the 89th Congress, except th at the effective 

date is 12 months after ena ctm ent rather than 6 months as provided in II.R. 

16474. T ha t bill was a perfected version of legislation first intro duce d in the 87th 

Congress. Extensive hearings were held in the 88th Congress; further hearings 

followed in the 89th Congress. H.R . 16474 was the clean bill which resulted from 

this intensive examination of legislation designed to consolidate provisions of the 

Act relating to animal drugs. In our report to you of Septem ber 8, 1966, we 

advised that the bill would be entirely acceptable if certain minor modifications 

were made. The bill was am ended to include these suggestions and as noted above, 

was repo rted and passed by the House of Representatives without opposition.

H.R. 3639 is acceptable to this Departm ent. Though the Food and Drug 

Administration migh t administratively implement most of the provisions delineated in the bill, the legal framework provided will help to expedite th e process. 

We would therefore recommend th at H.R . 3639 be enacted.

We are advised by the Bureau of th e Budget th at there is no objection to the 

presenta tion of this report from the stan dpo int of the Adm inistration’s program. 

Sincerely,

Wilbur J. Cohen,

Under Secretary.

Department of Agriculture, 

Washington, D.C., September 29, 1967.

Hon. Harley O. Staggers,

Chairman, Committee on Inters tate and Foreign Commerce, House of Representatives,

Washington, D.C.

Dear Mr. Chairman: This is in reply to your letter of March 13, 1967, 

requesting a report on H.R. 3639. The bill is entitled, “To protect the public 

health by amending the Federal Food, Drug, and Cosmetic Act to consolidate 

certain provisions assuring the safety and effectiveness of new animal drugs, and 

for other purposes.”

The proposed legislation contains subs tantive ame nda tory provisions to the 

Federal Food, Drug, and Cosmetic Act which, briefly stated, provide: (1) th at a 

“new animal drug” is deemed to be “ unsafe” a nd “ad ultera ted ” unless an applica ­

tion for such drug has been approved by the Secretary of Health, Education, and 

Welfare; (2) th at an animal feed bearing or containing a “new animal drug” is 

deemed to be “unsafe” and “a dulterated” unless applications for such drug and 

such feed, have been approved by said Secretary; (3) th at a food is deemed to be 

“a dulterated” if it is, or it bears or contains, a “new animal drug” unless an 

application for such drug has been approved by said Secretary; (4) an exception 

for a “new animal drug” from the definition of “food add itiv e” contained in the 

Act; (5) an exception of drugs for use in animals other th an man from the certification provisions of Sections 502(1) and 507 of th e Act relating to antibiotics, and 

separate certification provisions for new animal drugs composed in whole or in 

pa rt of certain a ntibiotics; (6) th at a “new an imal drug ” or animal feed bearing or 

containing a “new animal drug” shall not be deemed “unsafe” and “ad ultera ted ” 

if it is for “investigational use” and conforms to the terms of exempting regulations 

prom ulgated by the Secretary of Health, Education, and Welfare as provided 

therein, and that such exempting regulations, among other things, shall set forth 

conditions (if any) upon which animals treated with such drugs, and their products, 

may be marketed for food use; (7) th at a “new an imal drug” which induces cancer 

in man or animals will not be approved unless there is a finding by said Secretary 

that, under conditions of use specified on proposed labeling and reasonably certain 

to be followed in practice, (i) such drug will not adversely affect animals for which 

it is intende d and (ii) no residue of such drug will be found (by methods of examina-
12 ANIMAL DRUG AMEN DMENTS OF 196 7

tion pr es cr ib ed or ap pr ov ed by th e Sec re ta ry of H ea lth , Edu ca tion , an d We lfare) 

in th e ed ible po rtio ns of such an im als aft er sl au gh te r or in foo d yielde d by or 

de riv ed fro m tl e liv ing an im als; (8) th a t not hi ng in su bs ec tio n 801(d ) of th e Act 

shall au th or iz e th e ex po rtat io n of any new an im al dr ug or an im al fee d be ar in g or 

co nt ai ni ng su ch a drug , wh ich is “uns af e” with in th e mea ni ng of th e Act.

Se cti on 301(a ) of th e Fe de ra l Fo od , Dr ug , and Co sm etic Ac t pr ohib its th e in tr odu ct io n in to “in te rs ta te co mmerce ” , as defin ed in th e Act, of any food, dr ug , 

dev ice , or co sm eti c th a t is adult era te d or misbr an de d. U nd er th e pr ov isions of 

H .R . 363 0 a “new an im al dru g” for wh ich an ap pl ic at io n ha s not be en ap pr ov ed 

by th e Sec re ta ry of H ea lth , Edu ca tion , an d W elf are wo uld be de em ed to be 

adult era te d an d could not be sh ip pe d in in te rs ta te commerce ev en th ou gh such 

an im al dr ug m ay be an an im al vir us, seru m, toxin or a na logo us pro duct re gu la te d 

by th e Sec re ta ry of Agr icul ture unde r th e pr ov isions of th e Viru s-Se ru m -T ox in 

Ac t (21 U.S.C. 151-1 58).

The Viru s-Se rum-T ox in Ac t pro hi bi ts th e pr ep ar at io n, sal e, or sh ip m en t in 

in te rs ta te comm erc e, or im port at io n in to th e U ni ted St at es , of an y worthless, 

co nt am in at ed , da ng erou s, or ha rm fu l vir us, serum, toxi n or an alog ou s pro duct 

in te nd ed for use in th e tr eatm en t of do mes tic an im als . It also pro hib its th e p re par at io n, sale, or sh ip m en t as afor esaid , of an y vir us, serum, toxi n or an alog ou s 

pro duct m an ufa ct ur ed w ith in th e U nite d S ta te s an d in te nded for su ch use un les s 

and unti l it shall ha ve be en pr ep ar ed und er an d in co mplian ce w ith regu la tio ns 

pr es cr ib ed by th e Sec re ta ry of Agr icul ture a t an es ta blish m en t ho lding an unsu sp en de d and un re vo ke d license iss ue d by him . I t fu rt her pr oh ib its th e im port atio n of su ch pr od uc ts w ithout a per m it fro m th e Sec re ta ry of Agr icul ture . Th e Ac t 

pr ov id es pe na ltie s for viol atio n of its prov isi on s.

Reg ul at io ns iss ued by th e Sec re ta ry of Agr icul ture p urs uant to th e prov isi on s 

of th e Virus -S erum -T ox in Act se t fo rt h (1) re qu irem en ts for a lic en se d es ta bl ishm en t (e stab lis hm en ts a re insp ec ted pri or to li censing and a re s ubje ct to c on tinu in g 

in sp ec tion ); (2) st an dar ds, metho ds of pro du ct io n an d te st in g, and oth er requ ire ­

m en ts for th e pro du ct s pre pa re d a t su ch es ta bl is hm en ts ; (3) re qu irem en ts for th e 

labe lin g an d p ac ki ng of th e p ro duc ts ; (4) reco rd -k ee ping req ui re m en ts w ith resp ec t 

to th e pr od uc tion an d te st in g of th e pro duct s; (5) re quir em en ts for co ntro l of 

an im als us ed in th e pro du ct io n an d te st in g of th e pr od uct s, th eir dis infection an d 

di sp os iti on ; an d (6) pr ov isions w ith re sp ec t to th e su sp en sion or revo ca tio n of a 

ice nse or ou tli ne of pro du ct io n of a pro du ct . Th is D ep art m ent ha s also iss ued 

legu la tio ns purs uant to th is Ac t go ve rn in g th e pr od uc tion , di st ribut io n a nd e va lurt io n of ex pe rim en ta l vet er in ar y bio log ies un de r in ve stig atio n pr io r to licensin g, 

and tn e disp os iti on of an im als used to ev al uate su ch pr od uc ts.

U nd er th e prov isi on s of H .R . 3639 it ap pe ar s th a t an an im al dru g wo uld be a 

“ new an im al dru g” if it is no t ge ne rally reco gn ized as saf e an d eff ective un de r 

th e Fe de ra l Fo od , Dr ug , and Cos metic Ac t un les s it was re gul at ed un de r th e 

Fe de ra l Fo od and D ru g Act of Ju ne 30, 1906, and its lab el re pre se nt at io ns conce rn in g th e co nd iti on s of its use are st ill th e same.

The prov isions of H .R . 3639 could be in te rp re te d so as t o b ring viruses, serums, 

toxi ns a nd a na logo us p ro duct s pr es en tly re gul at ed b y th e Sec re ta ry of Agricu ltu re, 

unde r th e Viru s-Se ru m -T ox in Act, w ith in th e scop e of th e te rm “new an im al 

dru g” . The Sec re ta ry of H ea lth , E duca tion, an d W elf are does not no w ap pr ov e 

ap pl ic at io ns fo r su ch an im al biolog ies, wh ich ar e ex ce pt ed by re gu la tion (21 C F R 

130.2) fro m th e “ne w dru g” prov isions of th e Fe de ra l Fo od , Drug, an d Cos metic 

Ac t, and th ey m ig ht be de em ed “uns af e” und er th e pr ov isions of H .R . 3639 as 

ne w an im al dr ug s. I t is note d th a t th e de fin iti on of “ne w an im al dru g” in th e bill 

is ve ry s im ilar to t he d efinition of “n ew d ru g” in th e Ac t.

Viruses, se ru ms, to xi ns , an d an alog ou s pr od uct s comi ng with in th e pu rv iew 

of th e \ irus -S er um -T ox in Act are bio logical pr od uc ts. H isto ric al ly, th e Se cr etar y 

of A gr ic ul tu re ha s re gu la te d su ch an im al bio log ies , m an y of wh ich ar e not used 

fo r an im al s th a t ar e a so ur ce of hum an foo d. U nd er th e pr ov isions of H .R . 3639, 

th es e an im al bio log ica l pr od uc ts, if co ns id ered to be new an im al drug s, could not 

be sh ip pe d in in te rs ta te or foreign co mmerce , unt il ap plica tions th er ef or we re 

ap pr ov ed by th e Sec re ta ry of Hea lth , E duca tion , an d Welf are . Also, proc essin g 

of th es e ap pl ic at io ns wou ld be a du pl ic at io n of wo rk alre ad y be ing pe rfor med by 

th e D ep art m en t of A gr icul ture an d wou ld se rv e no useful pu rpos e.

How ev er, th is D epart m ent wo uld ha ve no ob jection to th e en actm ent of H .R . 

3639 so fa r as its im pa ct on an im al biolog ica l pro du ct s is co nc er ne d be ca us e of 

ou r re lia nc e on th e as su ra nc e by th e D epart m ent of H ea lth , E duca tion, and We lfare th a t th ey will, by re gu la tion , ex em pt bio log ica l pr oduct s su bje ct to lic en sin g 

un der th e Viru s-Se ru m -T ox in Act of M ar ch 14, 1913 (21 U.S.C. 15 1-15 8), fro m 

th e “n ew an im al dru g” pr ov isions of th e bill.
ANIMAL DRUG AMENDMENTS OF 19 67 13

Furt her , un de r th e prov isi on s of H .R . 3639 food wo uld be de em ed adult era te d 

an d ine lig ibl e for di st ri bu tion in in te rs ta te co mmerce if it be ar s or co nt ai ns a new 

an im al dr ug wh ich is not appr ove d by th e Sec re ta ry of H ea lth , E du ca tion , and 

W elfare or does no t m ee t ot he r re qu irem en ts. U nd er th e bill sa id Sec re ta ry wou ld 

als o ha ve auth ori ty to re gu la te th e m ar ke ting for food use of an im als tr eate d w ith 

in ve st ig at io na l new an im al drug s, an d th e pro duct s of su ch an im als .

U nd er th e M ea t In sp ec tio n Act and re la te d law s (21 U. S.C. 71 et seq.) th is 

D epart m ent co nd uc ts th e Fe de ra l m ea t in sp ec tio n pr og ra m for th e pu rp os e of 

pre ven ting the use in in te rs ta te o r for eig n co mm erc e of m ea t or m ea t f oo d pr oduct s 

of ca ttle , sheep, swine , go ats or ho rses th a t are un who les om e or othe rw ise un fit 

fo r hu m an food. Thi s pr og ra m inc lude s, am on g oth er th in gs , th e an te -m ort em 

in sp ec tion of th e an im als pr io r to th ei r sl au ghte r a t fe de ra lly in sp ec ted es ta bl is hm en ts and insp ec tio n of th e carcasses and m ea t food pro du ct s thereo f.

Reg ul at io ns iss ued p urs uant to th e pr ov isions of th e M ea t In sp ec tio n Act se t 

fo rt h th e co nd ition s of sl au gh te r a t es ta bl is hm en ts su bje ct to th a t Act of an im als 

us ed in rese ar ch invo lv ing th e adm in is trat io n of, or su bj ec tion of th e an im als to, 

ex pe rim en ta l bio log ica l pr od uc ts , drug s, or chem ica ls, an d re qu ire ap pr ov al by 

th e M eat In sp ec tio n Pro gra m fo r th e sla ug hte r of a ny su ch a nim al. The reg ul atio ns 

pro hib it th e ap pr ov al for sl au ghte r of any su ch an im al unles s th e su bst an ce us ed 

was pr ep ar ed an d dis tr ib ute d in co mplian ce w ith Fe de ra l law s specified th er ein, 

wh ich inc lude , wh en ap plicab le, th e ab ov e- m en tion ed Virus -S erum -T ox in Ac t an d 

th e Fed er al Fo od , D ru g a nd Co sm etic Ac t. The re gu la tion s als o pr ov id e for de nial 

or w ithd ra w al of ap pro val whe ne ve r de em ed ne ce ss ar y to pro te ct th e wh ole ­

somen ess of pr od uc ts pre pa re d under th e M ea t In sp ec tio n Act. The re gu la tion s 

als o re qu ire th e spec ial ha nd lin g on an te -m or te m in sp ec tio n of an im als su sp ec te d 

of ha vi ng be en tr eate d w ith or ex po sed to any su bst an ce in a m an ne r th a t may 

im p art a b iol ogica l r es idue t h a t m ay m ak e th e ed ible tiss ue s of th e an im al unw ho lesome or othe rw ise un fit for hum an foo d. The re gu la tion s als o pr ov id e th a t m eat 

food pro du ct s pre pa re d a t su ch es ta blish m en ts sh al l not be ar or co nt ai n pe sticid e 

or oth er bio log ica l resid ue s th a t m ak e th e pro duct s un fit fo r hum an food, an d 

pr ov id e fo r th e iss uing of in st ru ct io ns to insp ec tors sp ec ify ing th e st andard s an d 

pr oc ed ur es to as su re th a t su ch m eat food pro duc ts are wh ole some and othe rw ise 

fit for hu m an food. (See 9 C F R 309 .19, 309.20, and 318 .18 ).

A sim ilar insp ec tio n pr og ra m w ith re sp ec t to poult ry an d poultry pro du ct s is 

co ndu ct ed by th is D epart m ent unde r th e P oult ry P ro duct s In sp ec tio n Act 

(21 U.S.C . 451 et seq.).

Su bs ec tio n 902(b ) of th e Fed er al Fo od , Drug, and Cos metic Act (21 U.S.C. 

39 2(a)) and su bs ec tio n 18(a) of th e Poult ry Pro duct s In sp ec tio n Act (21 U.S.C . 

46 7( a) ), re sp ec tiv ely, ex em pt m eat an d m eat food pr oduct s an d poultry an d 

poult ry pr od uc ts fro m th e Fed er al Fo od , Drug, an d Co sm etic Act to th e exte nt 

of th e ap pl ic at io n or e xt en sion th ere to of th e M eat In sp ec tio n Act or th e Poult ry 

P ro duct s In sp ec tio n Ac t.

It is not antici pat ed th a t enactm ent of th e bil l wo uld re su lt in any ad ditio nal 

co sts to th is D ep ar tm en t.

The Bur ea u of th e B ud ge t ad vi se s th a t th er e is no ob ject io n to th e pre se nt at io n 

of th is re port fro m th e st andpoin t of th e A dm in is tr at io n’s p ro gr am .

Sinc erely yo urs,

J oh n A. Schnit tk er ,

Act ing Secretary.

Mr. Nelsen. Mr. Ch air man, I have a stat em en t I would like to 

mak e, if I may.

Mr. J arman. Ce rta inl y, Mr. Nelsen.

STATEMENT OF HON. ANCHER NELSEN, A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF MINNESOTA

Mr. N elsen. Mr. Ch air man and memb ers of the sub com mittee, I 

am mo st app rec iative of the op po rtu nity to ap pe ar before you to urge 

your favora ble con sidera tion of H.R . 3639. As you are aware, I have 

introd uced an ide ntical com pan ion bill, H.R . 364 1.

You will recall th at this legislation has been before this sub com ­

mittee on two previous occasions over the pa st 5 years. Th e mo st 

rec ent occasion was during the secon d session of the 89th Congress.

8 5 -4 1 9— 67 -------3
14 ANIMAL DRUG AMENDMENTS OF 19 67

Th e bill th at was acted on fav ora bly by the s ubc om mittee on this last 

occasion, with min or revisions, was eve ntu ally passed by the House, 

appearing as H.R . 16474.

T hat bill as passed and H.R . 3639 before us toda y is a res ult of 

trem end ous efforts on the pa rt of industry, Food and Dru g Adm inistra tio n, and congressional staff. H.R . 3639 rep resents, for the first 

time, a complete consensus betw een ind ustry a nd FD A and the staff, 

and will provide the legislative guidelines need ed to alle viate the 

pre sen t unwieldy procedures for clearing ani ma l dru gs ye t ma intai n 

desired pro tection of our public hea lth.

Th e anim al healt h indu str y has made great stride s in reducing 

food animal losses to farm ers, lowering food costs to consumers, and 

impro vin g the qu ality and prod uctiv ity of animal food products 

throu gh the research and dev elopment of these necessary gro wth 

agent s. This mo vem ent on the pa rt of indu stry has come ab ou t in 

sp ite of the cum bers ome preclearance procedures th at have, unfortuna tely, delayed and discouraged the dev elo pm ent and ma rketi ng 

of these pro ducts to comb at the varying disease losses which afflict 

our food animals.

W ith the incre ased need for more and be tter food to cope with our 

ever-growing population , improvem ent of clearance proc edures for 

ani ma l drugs is n ecessary. We have heard in the pa st of the pre sen t 

cum bersom e procedures which hav e cre ate d delays in excess of 2 

years at times.

W ith the incre ased efforts on the pa rt of the Comm issio ner of Food 

and Dru gs and the Direc tor of Ve ter ina ry Medicine, a willingness 

and ability to elim inate man y of these unneces sary ad ministrativ e 

procedures has been demo nstra ted . These admi nistr ative efforts, 

alon g with the legislative changes, will, I believe, provide the impro vem ents in prec learance procedures which are so despera tely 

need ed to alleviate thes e unnec essary d elays.

Th e need for this legislation is n ot o nly recognized by the Food and 

Dr ug Ad minis tration as de mo nstra ted by their tes tim ony tod ay, bu t 

also received strong su pp ort from the i mpo rta nt S ta te de pa rtm en ts of 

agriculture which are con tinuously invo lved in prote cti ng the public 

health. Su pport for this legislation, as de mo nstra ted by thes e gov ernments, is com plemen ted by the su pp ort of the scientific comm unity 

as rep res ented by feed manufactur ers of the Un ite d State s and the 

pract icing veterina rians who so ably assist in pro vid ing wholesome 

food and prote ct the public hea lth.

H .R . 3639, I feel, will assure us th at abs olu te and unn ecessary 

tim e-cons uming metho ds will be set aside and will aid in efforts to 

str eand ine clea rance procedu res. This simplified and effective pro ­

cedure would gre atly reduce costs to producers wi thou t reducing the 

rigid controls in the pre sen t law which are designed to pro tec t the 

public hea lth. H.R . 3639 should be passed wi thou t fu rth er delay.

Mr. J arman. Tha nk y ou very much, Mr. Nelsen.

We shall hear now from several colleagues who hav e sponsored 

sim ilar legislation. Fi rst to prese nt testim ony will be Mr. W att s, of 

Ke ntucky . Please proceed, Mr. W att s.
ANIMAL DRUG AMENDMENTS OF 19 67 15

STATEMENT OF HON. JOHN C. WATTS, A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF KENTUCKY

Mr. Watts. I am pleased to be afforded the opportunity to make 

this statem ent in support of H.R. 3639. My strong conviction of its 

merit prompted me to introduce an identical bill, H.R. 3642.

You will recall tha t the need for legislation specifically relating 

to drugs for use in animals and in their feed was brought to the 

attention of your paren t committee in 1962 during hearings on the bill 

H.R. 11581, which was enacted into law as the Drug Amendments 

of 1962. It was again presented to this subcommittee’s predecessor 

in September of 1963 when hearings were held on H.R. 7247. A number 

of amendments to tha t bill were suggested by the Food and Drug 

Administration and were agreed to by its proponents. Other amendments to insure adequate protection of the public health were worked 

out by representatives of the FDA, the congressional staff, and 

industry. The measure incorporating these changes was reported out 

of the subcommittee as H.R. 16474 in June 1966. That bill passed the 

House unanimously near the close of the 89th Congress, but failed 

to reach Senate hearings before adjournment.

The bill being considered now, H.R. 3639, is identical to H.R. 16474 

with the exception tha t the former provides for an effective date 12 

months rather than 6 months after enactment. This difference, I 

understand, is acceptable both to industry and to the Food and Drug 

Administration. I am firmly convinced tha t H.R. 3639 preserves all 

the safeguards presently contained in the Food, Drug, and Cosmetic 

Act.

The delay in favorable consideration and enactment of this legislation has been undue. I strongly urge the committee’s prompt action 

to report the bill as introduced by the subcommittee chairman, the 

Honorable John Jarman.

Mr. Jarman. Thank you for your brief statement, Mr. Watts. We 

are glad to have your views.

Our next witness will be our colleague from Missouri, the Honorable 

W. R. Hull. Please proceed, Mr. Hull.

STATEMENT OF HON. W. R. HULL, JR., A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF MISSOURI

Mr. Hull. I am delighted to be here, Mr. Chairman.

Mr. Chairman and members of the subcommittee, I wish to express 

my appreciation for the opportunity you have given me to appear 

before you in support of H.R. 3639. I have introduced an identical 

bill, H.R. 3643.

H.R. 3639 will amend the Food, Drug, and Cosmetic Act. It will 

consolidate those provisions of the act applicable to animal drugs. 

The present act requires tha t new animal drugs frequently be considered under two separate sections. Quite often subsequent clearances 

are necessary if the drugs are batch certified or are incorporated into 

animal feeds.

H.R. 3639 will consolidate these clearance procedures into one section of the law. This consolidation will in no manner remove present 

safeguards necessary for the protection of the public.
16 ANIMAL DRUG AMENDMENTS OF 19 67

The United States is the best fed country in the world today. Our 

agricultural technology has enabled us to fill America’s tables with an 

ever-increasing assortment of high-quality foods.

However, the population is growing at a fantastic pace, with an 

estimated 200 million Americans expected in 1967. These people must 

have an adequate nutritious food supply.

Today, animal diseases, parasites, and insects are stealing billions 

of dollars’ worth of food each year. The best efforts of research teams 

are needed in an all-out fight to reduce animal losses.

The passage of H .R. 3639 will be of enormous importance in this 

research effort. When enacted, it will streamline the procedures necessary to obtain clearances of new animal drugs needed to fight these 

livestock and poultry losses, and will encourage development of new 

drugs to combat yet unconquered food-animal diseases.

I am happy to note tha t Dr. Goddard is here to testify today. His 

interest in this measure is typical of the thoroughness with which he 

has taken hold of the FDA. His appointment of Dr. Clarkson, and more 

recently Dr. Van Houweling, to head up the new Bureau of Veterinary 

Medicine, also typifies his program of seeking highly qualified, competent people to carry on the work of this important agency.

I hope Dr. Van Houweling will find, in H.R. 3639, a valuable tool 

which will help him and the Bureau of Veterinary Medicine perform 

the difficult task of protecting the public health without unduly burdening an industry which must supply our Nation and much of the 

world with animal health and nutrition products.

I thank you very much for being able to appear before your committee this morning, Mr. Chairman.

Mr. Jarman. Thank you for your presentation, Mr. Hull. Are there 

any questions? If not, we shall hear next from Congressman Phil 

Landrum, of Georgia.

STATEMENT OF HON. PHIL M. LANDRUM, A REPRESENTATIVE 

IN CONGRESS FROM THE STATE OF GEORGIA

Mr. Landrum. Mr. Chairman and members of the subcommittee, 

I am appearing in support of H.R. 3639, and have introduced an 

identical measure, H.R. 8431.

The present Food, Drug, and Cosmetic Act requires that animal 

drugs be cleared under one or more separate sections. This is inconsistent, time consuming, and costly. H.R. 3639 will consolidate clearance procedures for animal drugs into one section, not only greatly 

improving the present law, but providing complete safeguards to 

public health and safety as well. In addition, the bill does not require 

additional funds or manpower to effect its provisions.

As you know, I represent the Ninth District of Georgia, a major 

area of broiler and egg production. The efficiencies in production are 

greater in the poultry industry than in any field of agriculture, but 

the risks are also high. Passage of this bill will accelerate the marketing 

of badly needed animal health products that could help reduce present 

losses. All this will be accomplished without reducing any current 

safety and efficiency standards.

For these reasons, H.R. 3639 will aid the poultry industry and the 

millions of consumers for which it provides broilers and eggs at such 

low cost.
ANIMAL DRUG AMENDMENTS OF 196 7 17

H.R. 3639 will not only be of the greatest benefit to my State of 

Georgia, but is required to meet future world food requirements. I 

urge its swift enactment.

Thank you, Mr. Chairman.

Mr. Jarman. Thank you for your concise statement, Mr. Landrum.

Our next witness will be our colleague from Indiana, the Honorable 

William Bray. Please proceed Mr. Bray.

STATEMENT OF HON. WILLIAM G. BRAY, A REPRESENTATIVE IN 

CONGRESS FROM THE STATE OF INDIANA

Mr. Bray. I am happy to present this statement to the subcommittee on H.R. 3639 and similar bills, including my own, H.R. 8741.

Enactmen t of this legislation will mean dosing the wide gap tha t 

now exists between clearance of new animal drugs and those for 

human use. This measure will eliminate duplication of effort, insure 

the necessary controls over manufacture and use of animal drugs, and 

make them more readily available to the livestock and poultry industry 

after they have been developed.

Past hearings before the appropriate congressional committees have 

shown the need for corrective legislative action in this field. Everyone 

concerned has suffered from the situation as it now stands: the inventor, developer, and manufacturer; the Government agency charged 

with regulation of such products; the producer who depends upon 

them so very much, and the average American consumer.

An impressive amount of statistical data has been prepared and 

presented to support this legislation. Livestock and poultry losses 

run into the billions of dollars annually. Those costs are borne by the 

farmer whose net income suffers accordingly. Likewise, the housewife 

is directly affected by the increased prices caused when less food is 

available in the stores.

The advances in the fields of science and technology over the past 

half century have been truly astounding. The great pharmaceutical 

houses of America have made outstanding contributions in the discovery, development, production, and distribution of drugs, serums, 

and antibiotics, which have immeasurably raised the living standard 

of all mankind. It is a m atter of personal pride with me th at the great 

firm of Eli Lilly & Co. is located in my congressional district. It is 

incumbent upon the Congress to insure tha t necessary regulations do 

not become negative restrictions. Favorable action on this legislation 

will accomplish that, end and will be of incalculable value to the health 

and well-being of all.

Mr. Jarman. Thank you for your views, Mr. Bray. We have one 

more colleague to hear from before Dr. Goddard. Our next witness is 

Congressman Stephens. Please proceed, Mr. Stephens.

STATEMENT OF HON. ROBERT G. STEPHENS. JR., A REPR ESEN TATIVE IN CONGRESS FROM THE STATE OF GEORGIA

Mr. Stephens. Mr. Chairman and gentlemen of the committee: 

I am glad to be given the opportunity to acquaint you with H.R . 

9002, a bill which I have introduced.

This bill would consolidate the premarketing clearance procedures 

for new animal drugs. As I will show the committee, the present 

procedure is far more complicated than tha t for human drugs. This
18 ANIMAL DRUG AMENDMENTS OF 196 7

bill is similar to those introd uced by Con gressman Jo hn Jarm an , of 

Oklahoma, Congres sman Phil Landrum, of Georgia, and others.

Th e F edera l Food , Dru g, and Cos metic Act contains several sections 

under which new a nim al d rug s m ust be cleared befo re t he y can be made 

available for use by the public. Section 409 deals with feed additives. 

Section 505 provide s for th e processing of new drug application s. 

Section 507 covers approv al of certa in ve terin ary antibiotics. As a 

consequence, separate are as of the Foo d and Dr ug Ad mi nis tration 

admi nis ter thes e three sec tions and ten d to ad op t ind ividual in terpreta tio ns of the act . This causes delay and confusion in the han dling 

of animal dru g clearances.

Applications for huma n new dru gs are sub mitted under section 505. 

These app lica tions conta in inf orm ation on the dr ug ’s components, 

com position, effectiveness, and safety . Descr iption s of the manufacturing facilities and a sam ple l abel are included. If appro ved, the huma n 

new dru g can be on the marke t in ISO days.

Th is is in co ntrast to the pre sen t com plic ated and time -consuming 

procedure for clearan ce of ani ma l new drug s. Th e different sections 

under w hich the ap plicat ion s a re presen ted have d iffe rent time re quirements. The agen cy has ISO da ys to act under section 505 and 210 days 

under section 409. Th e pro cedure for new dru gs inten ded for use in 

animal feeds is even more complex.

After t he i nitial applicat ion for the new dru g is a pprov ed, each feed 

ma nu factu rer m ust o bta in a secondar y clearan ce for each of his plants. 

Th is comes again under section 505 which allows 180 day s for clearance. Therefo re, it can take more th an a year in to ta l tim e to process 

the required clea rance for one drug. In some are as the req uirem ent s 

conflict, and the tim e for approv al can dra g on for years.

Under my bill, H.R. 9002, all a pplications for an imal new drugs would 

be processed under a new se ctio n 512 of t he act. Th e app lica tion would 

con tain com plete inform atio n on controls, com pon ents, safety, 

effectiveness, facilities, and labeling. Th ere w ould be allowed 180 day s 

within which the applicat ion could be appro ved or denied or more 

inform ation requested. If appro ved it could be marke ted in 180 days. 

If the dru g was to be used in anima l feed the mills would apply for 

appro val prior to marke tin g and 90 d ays would be allowed to process 

the mill’s application. Therefore, a new feed ad dit ive could be on the 

marke t in 9 m onths ins tea d of the presen t 12 to 14 months.

H.R . 9002 and th e other bills before you provide ample pro tection 

for the public healt h by re tai nin g all of th e necessary safet y sta ndard s. 

As I sta ted previou sly all applicat ion s mu st conta in detaile d inform ation and are subje ct to careful review under th e dire ctio n of the 

Secre tary of He alt h, Ed ucati on, and Welfare.

Pas sag e of this bill would mea n the savings of millions of dollars 

eac h ye ar to farmers and housewives. I was am aze d to discover th at 

the U.S. Dep artm en t of Agriculture has estim ated th at we lose $2.8 

billion per year throug h losses of live stoc k and poultry. These great 

losses are caused by diseases, par asites, and inse cts. Although use 

of a wide va rie ty of anima l healt h pro ducts, feed add itiv es, a nd growth 

agents has become sta nd ar d practice, new an d be tter anim al drug s 

are needed to cu t down on this great loss to the A merican people and 

its economy. Th is bill wou ld encourage the dev elopment of new 

animal drugs needed to fight thes e food losses and would stre amline 

the app roval of thes e drugs.
ANIMAL DRUG AMENDMENTS OF 19 67 19

Dr. Malcolm Reid, poultry parasitologist of the University of 

Georgia College of Agriculture at Athens, Ga., has recommended 

ending clearance for efficacy of additives to animal feeds as now 

required by the U.S. Food and Drug Administration. He bases his 

recommendations upon his research experience in evaluating coccidiostats, drugs developed for incorporation in poultry feeds to 

prevent coccidiosis in commercial flocks of broilers and laying hens. 

Scientists estimate that, without coccidiostats, coccidiosis would cost 

the U.S. poultry industry $100 million annually in death and poorgrowth losses of birds. Dr. Reid has pointed out tha t the manufacturers of two of the most promising new coccidiostats, not yet cleared 

for use, each has spent more than a million dollars developing and 

testing these drugs. One of these products has been manufactured and 

marketed for sale in England for over 10 months and in Australia 

for over 6 months while both still await clearance in the United 

States due to the complicated procedures required for clearance of 

such products.

The bills before you are supported by the Animal Health Institute, 

the Georgia Poultry Federation, the National Association of State 

Departments of Agriculture, the Pharmaceutical Manufacturers 

Association, the American Feed Manufacturers Association, the 

American Veterinary Medical Association, and a number of other 

national and regional organizations. The need for this legislation is 

evident, and I hope the committee will be able to reach an agreement and report favorably on one of the bills before you.

Mr. Jarman. Thank you for your testimony, Mr. Stephens.

Our next witness this morning, and the subcommittee is very pleased 

to welcome him again, is Dr. James L. Goddard, Commissioner of 

the Food and Drug Administration, and his associates.

STATEMENT OF HON. JAMES L. GODDARD, M.D., COMMISSIONER

OF FOOD AND DRUGS, DEPARTMENT OF HEALTH, EDUCATION,

AND WELFARE; ACCOMPANIED BY THEODORE ELLENBOGEN,

ASSISTANT GENERAL COUNSEL FOR LEGISLATION; AND DR.

FRED J. KINGMA, DEPUTY DIRECTOR, BUREAU OF VETERINARY

MEDICINE

Dr. Goddard. Thank you, Mr. Chairman. I have with me today, 

Mr. Theodore Ellenbogen, from the General Counsel’s Office, and 

Dr. Fred J. Kingma, the Deputy Director of the Bureau of Veterinary Medicine.

I have a brief statement I would like to read, if I may, Mr. Chairman, for the record.

Mr. J arman. We will be glad to receive it.

Dr. Goddard. I appreciate your invitation, Mr. Chairman, to 

appear before your committee to discuss H.R. 3639, a bill to amend 

the Federal Food, Drug, and Cosmetic Act with regard to the safety 

and effectiveness of drugs intended for animal use.

The principal effect of the bill would be to consolidate in a new 

section of the Federal Food, Drug, and Cosmetic Act the premarketing 

clearance sections present in the existing law which are applicable to 

new drugs used to treat animals or to animal feeds containing such
20 ANIMAL DRUG AMENDMENTS OF 19 6 7

drugs; namely, section 409 (Food Additives), section 505 (New 

Drugs), and section 507 (Antibiotic Drugs).

Insofar as animal drugs and medicated feeds are concerned, these 

three sections would be replaced by the proposed section 512. The 

bill also includes transitional provisions to protect the holders of 

approved applications for veterinary drugs and medicated feeds and 

to assure that there will be no hindrance in the continuous application 

of the enforcement provisions of the act during the period of changeover in the administration of the provisions of the current act to the 

new provisions contained in this bill.

Bills designed to codify the animal drug sections of the Federal 

Food, Drug, and Cosmetic Act have been under consideration since 

the introduction in the 88th Congress of H.R. 7247, the Animal Drug 

Amendments of 1963. Extensive hearings were held on this proposal 

in the 88th Congress, which were followed by further hearings in 

the 89th Congress.

The immediate forerunner of the current bill, H.R. 16474, the 

Animal Drug Amendments of 1966, was introduced, reported favorably 

by your committee, and passed by the House of Representatives in 

the 89th Congress.

You will recall, Mr. Chairman, tha t I appeared before this committee on June 13, 1966, and discussed the implications of H.R. 16474 

for the Food and Drug Administration in our handling of the large 

volume of submissions pertaining to drugs for animal use tha t are 

reviewed each year. We have, as you know, worked very closely 

with your committee in developing the present clean bill. The one 

notable change made in H.R. 3639 is the extension of the effective 

date to 12 months, in lieu of the 6-month period provided in H.R. 

16474. This change was suggested by the industry, and this extension of time is quite acceptable to us.

We believe the bill, if enacted in its present form, would provide 

for the following procedural handling of applications for new animal 

drug uses:

(1) The manufacturer, packer, or distributor would file an application to establish the conditions of safe and effective use of a new 

animal drug, whether it is intended for direct action in animals or 

for use in feed or drinking water.

The Department would publish, upon approval of the application, a 

regulation giving the name and address of the applicant and the conditions and indications of use of the drug covered by the application to 

assure safe and effective use, including any authorized tolerances or 

required withdrawal period, any special labeling requirements, and 

any other information deemed necessary.

(2) A feed manufacturer desiring to use the new animal drug in 

medicated feed would be required to describe in his application how 

the feed will be prepared; detail the mothods, facilities, and controls to 

be employed; and submit specimens of the labeling to be used on the 

feed product and, if requested, samples of the feed or its components.

(3) In those instances where, in our judgment, there are grounds 

for refusing to approve an application, each applicant, the drug 

manufacturer as well as the feed producer, would be entitled to a 

hearing. The bill affords the same opportunity for a hearing with 

respect to any proposed withdrawal or modification of the approval.
ANIMAL DRUG AMENDMENTS OF 19 67 21

If the basic appr oval for the new animal drug were proposed to be 

withdraw n or modified, the drug manufacturer would he entitled to a 

hearing, and the feed manufacturer would be entitled to intervene. A 

final w ithdrawal of approva l of the new animal d rug application would 

aut omatic ally result in withdr awal of the approva l of the medicated 

feed applications based upon it.

(4) The handling of antib iotics in animal feeds would remain 

essentially the same under H .R . 3639 as under present law.

Th e bill includes a transitional provision which continues in effect 

all prior approvals and allows the holder of any such appr oval to 

propose amendments, or the Dep artm ent itself to modify or withdraw any such approva l under the new procedure that would be 

provided bv H.R . 3639.

Mr. Chairman, you will recall that when I appeared here last year , 

I gav e you a brief resume of some of the things we contemplated to 

facilita te more efficient review and action on the handling of applications for new animal drugs and medicated feeds.

We have enhanced our working relationship with the veterin ary 

drug and medicated feed indu stry and the associations representing 

these industries. As a resu lt of this close working relationship, the 

industry has been subm ittin g more complete and better organized 

information. Thi s has reduced man y of our problems in revie wing 

applications and has enabled us to significantly reduce the amou nt of 

time necessary to process and act upon the applications. We are 

continually looking for better and faster methods of handling submissions, and we hope to atta in the goal of keeping completely current 

in taking up applicatio ns as they are reviewed.

Mr. Chairman , you might be interested in knowing tha t the review 

for efficacy involving all drugs which were the subje cts of new drug 

applications approved between 1938 and 1962 is proceeding nicely. 

Th e Nationa l Academ y of Sciences, with whom we have contracte d 

to do this project, has assured us tha t we may expect the first reports 

with in a few months. The job should be completed by the end of 

June 1968.

Th e regulations dealing with good manufacturing practices for 

medicated feeds have been separated from those of drugs generally 

in recognition of the special requirements for this typ e of man ufac ­

turing facility. Proposals for good manufacturing practice regulations 

covering the intermediate or “ premix” facilities were published in the 

Federal Register inviting comments from interested parties. Havin g 

considered the comments received, we are now engaged in preparing 

a final order for publication in the Federal Register.

Although good manufacturing practice requirements are not dealt 

with in the bill now before the comm ittee, the recognition of the 

special needs in these areas is essential to an appreciation of some of 

the problems we hav e experienced in the clearance of drugs for anima l 

use.

New regulations have been issued setting forth the rules for veter inary inve stiga tional drugs. B y sepa rating the requirement for vet erinary drugs from those established for human drugs, we have give n 

attention to the special needs in this area for the developm ent of 

laboratory and clinical data with regard to the protection of meat, 

milk, and eggs derived from animals used in investigations.
22 ANIMAL DRUG AMENDMENTS OF 196 7

The former Division of Veterinary Medicine has been elevated to 

full bureau status, and we have clearly established in this Bureau the 

responsibility for the handling of drugs for animals. Final authority 

for approval of applications for new animal drugs and medicated feeds 

has now been delegated to the Bureau Director.

Veterinary personnel handling certifiable antibiotic applications, 

previously assigned to the Division of Antibiotic and Insulin Certification, are now located in the Bureau of Veterinary Medicine. The 

Bureau is now handling NDA’s and medicated feed applications involving certifiable antibiotics along with other veterinary NDA’s and 

medicated feed applications.

The Bureau of Veterinary Medicine is also responsible for the 

clearance of food additives for animal use as well as the clearance of 

new drugs intended for animal use. The bureau maintains a continuing 

liaison with toxicologists and pharmacologists in the Bureau of Science. 

This liaison permits the full utilization of the scientific competence 

in each of the two bureaus, and it assures tha t decisions concerning 

food additives will be consistent between the two bureaus.

We have taken further steps to increase the competency of the 

Bureau of Veterinary Medicine by recruiting additional scientists of 

the highest qualifications to complement the capabilities of the current 

staff.

We are continuing to place heavy emphasis upon a comprehensive 

program of both intra- and extra-mural training for our staff in the 

scientific disciplines of pharmacology, toxicology, physiology, and 

epidemiology, all of which bear directly upon drug law administration.

The various reorganizations of function and other innovations which 

I have mentioned are designed to expedite our handling of the review 

and approval of new drugs for animal use. We intend to continue our 

quest for improved methods of dealing with these problems to assure 

tha t drugs and food additives for animal use are safe and effective. 

We intend, of course, to pursue the same objectives under H.R. 3639 

if enacted.

We add our endorsement of H.R. 3639 to tha t of the Department 

which was set forth in the Departm ent’s report of July 10, 1967, to 

Chairman Staggers, and recommend the enactment of this bill in its 

present form.

Thank you, Mr. Chairman, for the opportunity to discuss this proposed legislation with you. I will be glad to respond to any questions 

which the committee may have.

Mr. J arman. Thank you, Dr. Goddard.

One question occurs to me that I think should be clarified for the 

record.

On page 28 of the bill, section 106, lines 10 through 16, an amendment is made concerning animal drugs or feeds for export.

Dr. Goddard. Yes.

Mr. J arman. Does this change the existing law?

Dr. Goddard. No, sir; this does not. This provision is currently in 

effect. It simply is to make it consistent with current law and not 

to change it.

(The following correspondence was subsequently submitted:)
ANIMAL DRUG AMENDMENTS OF 196 7 23

H ouse o f R e p r e s e n t a t iv e s,

C o m m it tee on I n ter sta te an d F o r eig n C o m m er c e,

Wa shi ngt on, D.C., October 5, 1967 .

Dr. J ames L. G od dard ,

Commissione r, Food an d Dr ug A dm in istrat ion,

Wa shing ton , D.C .

D ea r D r. G odd a rd: D uring ou r he ar in gs on O ctob er 3 on H .R . 3639 , yo u will 

reca ll I as ke d yo u if se ct ion 106 of th e bill mad e an y ch an ge in ex istin g law , an d 

yo ur re pl y wa s th a t th is se ct io n di d not mak e a ch an ge .

Tes tim on y pr es en ted su bse que ntly in di ca te d th a t th er e may be s om e difference 

of op inion w ith re sp ec t to th is po sitio n. I wo uld , ther ef or e, ap pre ci at e it if yo u 

wou ld fu rn ish th e Sub co m m itte e w ith a m em or an du m ex plaining th e legal si tu ation w ith re sp ec t to pr oh ib itio ns ag ai nst ex po rts of new an im al dr ug s and an im al 

fee ds be ar in g or co nt ai ni ng new an im al drug s, an d an ex pl an at io n of wh y se ction 

106 mak es no su ch change.

Sincerely yo urs,

[John J arman,

Chair ma n, Subco mm ittee on Pu bli c Hea lth and Wel fare .

D epa r t m e n t of H ea l t h , E d u c a tio n, and W e l f a r e,

F ood an d D rug, Ad m in is tr a tio n

Wa shing ton , D.C ., October 19, 1967.

Hon . J ohn J arman,

Ch air ma n, Sub comm itte e on Pu bli c He alth an d Sa fety, Comm ittee on Inter sta te and

Foreign Commerce, Ho use of R epr ese nta tives, Washing ton, D.C.

D ea r M r. J a r m a n : T hi s is in re sp on se to your le tt er of Octob er 5, as ki ng for

a m em or an du m as to th e leg al si tu ati on, un de r ex isting law , w ith re sp ec t to 

ex po rts o f new a ni m al d ru gs , and of a nim al fe ed s be ar in g or c onta in in g suc h drug s, 

and a n ex pla nat io n of th e eff ect of Sec . 106 of H .R . 3639 (“ A nimal D ru g Amen dm en ts of 1967” ) on th a t situ at io n.

Yo ur le tt er refers to testi mon y-—w hich , I under st an d, was give n by a re pr ese nta ti ve of th e an im al feed in dust ry — in di ca ting some diffe renc e of op inion w ith 

re sp ec t to my resp on se, in an sw er to a que st io n a t th e he ar in g, as to th e eff ect of 

Sec. 106 as co m pa re d to pre se nt law .

I a m t ra nsm it ti ng h er ew ith a m em or an du m , pre par ed b y co un sel, co ve rin g th es e 

po in ts. It ap pea rs fro m th a t m em ora nd um th a t Sec. 106 of th e bill wou ld not 

ch an ge th e si tu at io n as to ex po rts under ex istin g law an d re gu la tion s for new 

dr ug s an d feed s m ed ic at ed th er ew it h, or fo r anti bio ti cs in te nded for use in fee d 

or antibi ot ic -c ont ai ni ng feed s th em se lv es . On ly fo r th os e an ti bio ti cs th a t ar e 

in te nded for di re ct ad m in is tr ati on to an im al s (r ath er th an in an im al feed ) an d 

th a t ar e now su bj ec t to b atc h-b y-b atc h ce rtificatio n do m es tic ally , co uld Sec. 106 

be s aid to work a ch an ge leg all y by e xte nd in g th e pro te ct io n of th e ba tc h ce rti fic ation re quir em en t to ex po rts. Th is, in my ju dgm en t, af fe cts on ly th e basic dr ug 

m anufa ctu re r and no t th e feed in dust ry . It see ms clea r from th e en clo sed mem ­

ora ndum th a t th e f ea rs o f th e a nim al feed in dust ry th a t Sec. 106 o f th e bill wo uld 

pre vent it from ex po rtin g an y of it s pro duct s which it is au th ori ze d to ex po rt 

un de r ex isting law ar e n o t ju stifie d.

Sinc erely yo urs,

J ames L. G oddard, M .D ., 

Co mm iss ion er of Food an d Drugs.

m em orandum c o n c e r n in g st a tu s o f n e w a n im a l dru g s, an d o f anim al

FE E D S B EA R IN G OR C O N T A IN IN G SU C H DRUG S, W H E N IN T E N D E D FO R EX PO R T 

U N D E R E X IS T IN G LA W A ND U N D E R § 106 OF H .R . 3639.

1. With respect to “new drugs” an d fee ds med icated therew ith.

Se ct io n 801(d ) of th e Fed er al Fo od , Dru g, and Cos m et ic Act pr ov id es th a t a

foo d, dr ug , devic e, or co sm etic in te nded for ex po rt “sh all not be de em ed to be 

ad u lt era te d or m is br an de d unde r th is A ct” if it ac co rd s to th e spec ifi ca tio ns of 

th e for eig n pu rc ha se r, is not in co nflic t w ith the law o of th e countr y o f d es tinat io n, 

and is la be le d on th e ou ts id e of th e sh ip pi ng pa ck ag e to show th a t it is in te nd ed 

for export . I t will be note d th a t th e ex em pt ion co nt ai ne d in § 80 1(d) of th e Ac t 

ap pl ie s on ly t o a rtic le s which in th e a bs en ce of § 801 (d) wou ld b e d ee med “a d u lt era te d ” or “ m is bra nded ” under oth er prov isions of th e Act. (F or pr ov isions as to 

when a dr ug is de em ed “ad u lt era te d ” “or m is bra nded ” see §§5 01 an d 502 of 

th e Ac t.)
24 ANIMAL DRUG AMENDMENTS OF 196 7

Se ctio n 505 of th e Act m ak es it un law fu l to sh ip a “ne w dru g” in in te rs ta te 

co mmerce unles s th e dr ug is co ve red b y an ap pro ved ne w -d ru g ap plica tion un de r 

§5 05 . A “ new dru g” th a t is not co ve red by or in co nf or m ity w ith a ne w-drug 

ap pl ic at io n, ho wev er, do es not th ere by be come a n “ad u lt era te d ” or “m is bra nded ” 

dr ug w ithi n th e mea ni ng of th e Act. In oth er wo rds , in so fa r as th e pr em ar ket - 

clea ranc e re qu ir em en t for “ new dru gs” is co nc erne d, th e A ct do es not em ploy 

th e te ch ni qu e of de em ing su ch a d ru g to b e “ad u lt era te d ” or “ m is bra nded ” , w hich 

is a te ch niq ue us ed in th e Ac t on ly in oth er resp ec ts. Hen ce , th e pr ov ision of 

§ 801 (d) th a t a dr ug in te nded for ex po rt sh all not be de em ed to be “a d u lt era te d ” 

or “m is bra nded ” un de r th e Act doe s not ha ve th e eff ect of ex em pt in g a new dr ug 

wh ich is not co ve red by or in co nf or m ity w ith an ap pr ov ed ne w -d ru g ap pl ic at io n 

fro m th e pr oh ib itio n ag ai nst sh ip m en t in “in te rs ta te co mmerce ” , a te rm which is 

de fin ed in th e Ac t so bro ad ly as to incl ud e both do mes tic an d foreign co mm erc e 

cro ssing S ta te lin es. W hat ha s been sa id w ith re sp ec t to “ne w dru gs” ge ne rally 

lik ew ise ap plies, un de r ex istin g law , to an im al drug s, incl ud in g fee ds th a t (by 

reas on of co nt ai ni ng a “ne w dru g”) ar e them se lves classified un der pr es en t 

law as “ne w dr ug s” .1

H .R . 3639 , how’ev er, in pr op os ing a se pa ra te re gul at ory sc he me for “n ew 

dr ug s” th a t ar e in te nd ed for use in tr eati ng or fee din g an im als, w het her dir ec tly 

or in th e form of m ed ic ated feed— which , re sp ec tiv ely, ar e re fe rred to in th e bil l 

as “new an im al dr ug s” and “feeds be ar in g or co nt ai ni ng a new an im al dru g”— 

ap plies to su ch drug s th e tech ni qu e, els ew he re used in th e Act, of de em ing th em 

“adult era te d” if the y do n ot m ee t th e sta tu to ry p re m ar ket -c le ar an ce r eq uirem en t. 

Thu s, in or de r to pres erve w ith re sp ec t to such drug s, an d for feeds m ed ic ated 

w ith th em , th e st atu s qu o ante in so far as ex po rts ar e co nc erne d, it wa s ne ce ss ary, 

as pr op os ed in § 106 of H .R . 3639, to pr ov id e ex pres sly th a t § 801(d ) does not 

au th or iz e th e ex po rtat io n of a new an im al dr ug or of an an im al feed be ar in g or 

co nt ai ni ng su ch dr ug which vi ol ates th e pr ec le ar an ce re quir em en t of th e bill.

2. W ith respect to certifiable an tibiotics an d feeds med icated with an tibiotics .

U nd er pr es en t law (§ 507 of th e FD &C Ac t) an d re gu latio ns , drug s co ns istin g 

of or co nt ai ni ng ce rtai n an tibio tics (penici llin, st re pto m yci n, ch lo rtet ra cy cl in e, 

ch loramph en icol, and ba ci trac in ), and th eir de riva tive s, whe n in te nded for 

di re ct adm in is trat io n to an im als, are su bje ct to bat ch-b y-b atc h ce rtificatio n by 

th e D epart m ent of H EW and are de em ed adult era te d un de r § 502(1 ) if not fro m 

a ce rtifie d bat ch . So long as th es e antibio tics are su bje ct to § 507, th ei r failu re to 

comp ly w ith th a t section does no t, how’ever , re nd er th em adult era te d for ex port 

pu rpos es, in vie w of th e ab ov e- qu ot ed prov ision of § 801(d ) of th e Ac t, if th ey 

m ee t th e special re qu irem en ts of § 80 1( d) .

F or th is na rr ow ca te go ry of dr ug s, ther ef or e, ex po rts wo uld , an om alou sly, fall 

leg all y, unde r ex istin g law , with in th e ex em pt ion pr ov ision of § 801(d) inso far 

as bat ch -b y-b atc h ce rtificatio n is co nc erne d, al th ou gh it see ms dif fic ult to im ag ine 

w hy a for eig n im porter wou ld not in any ev en t in sist on buyi ng on ly an tibi ot ic s 

fro m a ce rti fie d ba tc h, if th e dr ug is in te nded for direc t ad m in is tr at io n to an im als. 

To th is exte nt on ly co uld § 106 of H .R . 3639 be sa id to na rrow th e pre se nt ex po rt 

ex em pt ion, b u t this, as in di ca te d below’, does not affect feed m an ufa ct ure rs . To 

th e exte nt th a t such dr ug s are ex em pt ed by th e Sec re ta ry fro m bat ch -b y-b at ch 

ce rtificatio n, ho we ver, and t he re fo re become su bj ec t to th e ne w -d ru g re qu irem en ts 

of th e Ac t, a failu re to co mply w ith th os e re qu irem en ts wo uld , fo r reas on s ab ov e 

st ate d, not be excused und er § 8 01 (d).

In so fa r as th es e an tibio tics ar e in te nded for use in an im al fee d, th ey ha ve be en 

ex em pt ed from th e bat ch -b y-b at ch ce rtificatio n re qui re m en ts by re gu la tion , and 

we ar e not aw ar e of any c ircu m stan ce , a t th is tim e, th a t wo uld be r ea so n for w ith ­

dr aw al of th a t ex em pt ion. The y are th u s su bj ec t to th e ne w-d ru g pr ov isions of 

th e A ct an d, for reas on s al re ad y ex plaine d, not w ith in th e ex port ex em pt ion th a t 

is e xt en de d by § 801(d ) on ly t o dr ug s th at, do mes tic ally, are de em ed “a d u lt era te d ” 

or “ m is bra nded ” . Ag ain , for reas on s ab ov e ex plaine d, § 106 of H .R . 3639 th us 

wou ld n ot , in actu al eff ect, ch an ge th e ex istin g si tu at io n for th is grou p of drugs.

Fin al ly , an im al feed s them se lv es th a t ha ve be en m ed ic at ed w ith thes e an ti ­

biotics ha ve be en ex em pt ed by re gu la tion from th e re quir em en ts of § 507 of th e 

Ac t, and th ey als o ar e n o t su bje ct to bat ch -b y-b atc h ce rtificatio n un de r H .R . 

3639 . U nd er ex ist ing law’, ther ef or e, su ch m ed ic at ed fee ds ar e su bje ct to th e newdr ug re qu ir em en ts of th e Act and hence, as ab ov e ex plaine d, ex po rts th er eo f ar e 

n o t ex em pt ed in th a t re sp ec t unde r § 801(d ) of th e Ac t. Thu s, ag ain, § 106 of 

H .R . 3639 eff ects no ch an ge in th is rega rd .

* A new drug in such a feed may also be “food additive” u nder present law. in which event the feed would 

be deemed an adulterated food (un der §§ 402 and 409 of the Act) in the absence of a regulation permittin g use 

of the drug in the feed and unless the actual use conformed to the regulations. While this provision would not apply to exports in view of § 801(d), that fact would not relieve the exporte d feed from the new-drug requ irem ents of the Act.
ANIMAL DRUG AMENDMENTS OF 19 67 25

Mr. J arman. Because with your help our subcommittee did cover 

this subject last year and took an almost identical bill through the 

House. Our questioning this morning will be much more brief, because 

the record already reflects all that.

Dr. Goddard. I understand that.

Mr. J arman. Mr. Nelsen?

Mr. Nelsen. Thank you, Mr. Chairman.

Having followed this legislation for years, Dr. Goddard, there 

seems to be some apprehension about what we are really doing here.

I recall correspondence tha t I received from a feed manufacturer back 

home, stating tha t under present law one firm could be using a 

formula on X side of the street and another firm might want to 

make exactly the same mixture with the same ingredients but since 

this is a new operation he had to go through a long application procedure while all the safeguards had already been provided for in the 

first examination.

By law you are unable to grant a permit to go ahead with this other 

company tha t should enjoy the same privilege.

Now, as far as we know and understand, all the safeguards are 

provided in this bill tha t were in the law originally. All the protection 

tha t you possibly can give the general public will continue to exist.

Dr. Goddard. Yes, sir.

Mr. Nelsen. But the procedure is going to be more streamlined 

to make it easier for you and also for the feed manufacturers to 

proceed.

Now, does this bill affect the authority of the Food and Drug 

Administration as to antibiotic residue or the development of drugresistant strains of bacteria?

Dr. Goddard. No, sir.

Mr. Nelsen. Food and Drug has every auth ority tha t they have 

had-----

Dr. Goddard. We have ample authority in this area now, and our 

authority will continue. Of course, the problems involved are rather 

difficult. They require the patience of all of us and the scientific capability of a great m any organizations. We are pleased th at groups such 

as the National Academy of Science, as well as others, are interested 

in this problem. I t’s a growing one.

Mr. Nelsen. I understand I ’m just bringing this out for the record 

because we were always confronted with misunderstanding as to 

wha t we are trying to do in this legislation.

Dr. Goddard. Yes.

Mr. N elsen. We don’t want to reduce any safeguards; at the same 

time we want to do everything we can to make it possible to live with 

it from your point of view and also from the manufacturers’ point 

of view.

Dr. Goddard. Yes.

Mr. Nelsen. Now, I recall in the last session of Congress the 

Minnesota Commissioner of Agriculture indicated that he was fearful 

of this bill. I ’m sure there is some misunderstanding on his part, but 

I want to be sure tha t we have covered every safeguard tha t we need 

to have in this legislation.

Now, the large and small manufacturers are equally treated, are 

they not? There is no danger to a small manufacturer whatever?
26 ANIMAL DRUG AMENDMENTS OF 19 67

Dr. Goddard. None that I have ever been able to detect.

The only problem, if I may, tha t a small manufacturer has in entering the area of new drug investigation is his limited resources as contrasted to a large manufacturer. But in our handling of applications 

we make every effort to give as prompt and as much consideration to 

the small manufacturer. With his limited resources, I must say he 

sometimes isn’t able to do as good a job as the large manufacturer 

and we have attem pted to correct this to give him and all others some 

assistance by organizing seminars in different parts of the country.

Dr. Kingma. I think over 18 seminars have been held throughout 

the last 12 months throughout the country.

Is this currently going on, Dr. Kingma?

Dr. Goddard. Through these seminars we hope to provide better 

understanding of the regulations and how to comply with them in the 

form of submissions, and other subjects.

Mr. Nelsen. I want to thank you, Dr. Goddard, for your appearance here.

Mr. J arman. Dr. Carter?

Mr. Carter. Thank you. What seems to be the biggest reason for 

this legislation?

Dr. Goddard. This brings together in one act all of those items 

tha t affect animal drugs, feeds, and the use of antibiotics therein. It 

clarifies and explains some procedures we currently are employing.

We think it represents good legislation. I t doesn’t provide any new 

authority, in my analysis or the Departm ent’s analysis, but simply 

brings it together, gives visibility to the handling of animal drugs, 

animal feeds.

Mr. Carter. Yes, of course, we are familiar with many, many 

of the feed mixers, of the fact tha t they use different antibiotics and 

many of the people who feed hogs, particularly, and cattle, claim they 

get beneficial results.

What are the adverse results that have been noticed from feeding 

these animals on feeds combined with a certain amount of antibiotic?

Dr. Goddard. I must say aside from some very isolated reports, 

if you are speaking of adverse results on humans-----

Mr. Carter. Yes.

Dr. Goddard. Aside from some isolated reports, our concerns are 

more in the realm of theory and speculation. Is this fair, Dr. Kingma?

Dr. Kingma. Yes.

Dr. Goddard. We are concerned about resistant strains of organisms, about the development of the R-factor which can provide 

cross transfers of resistance to other organisms. These fears have not 

been validated as far as humans are concerned.

We are well aware, though, tha t in laboratory work, more than a 

theoretical possibility, it lias actually developed. So the entire 

scientific community, working with the individuals involved, is attempting to control the usage of antibiotics. There is no question of 

their value if properly used.

Rather, we have to be concerned tha t we don’t overuse them. 

There is a possibility of sensitizing people to antibiotics, as you well 

know; if you selected an optimum way to sensitize someone, it would 

be small doses repeated a t frequent intervals, so we hope to-----

Mr. Carter. You think tha t would sensitize an individual?

Dr. Goddard. I think it’s certainly one of the methods used.
ANIMAL DRUG AMEN DMENTS OF 19 67 27

Mr. Carter. To sensitize them or desensitize them?

Dr. Goddard. Both, interestingly enough. But therapeutically inadequate doses have been known to produce sensitivities.

Mr. Carter. Do you want to ban the use of antibiotics for feed 

people who use tha t in their feed?

Dr. Goddard. No, sir; unless there is clear reason for concern or 

demonstrated alternate methods, we don’t wish to ban them.

Mr. Carter. Well, I can understand that. Of course, we see that 

drugs do become—or the bacteria become resistant in so many cases 

to the different antibiotics. We noticed tha t particularly in increased 

amounts of penicillin and other drugs which we have had to use, 

where at one time only a small amount had to be used.

Dr. Goddard. I can recall using 20,000 units.

Mr. C arter. As I recall, in 1944, when the use really started in the 

Army, even a small dosage such as 10,000 units for 3 hours was 

considered adequate and it seemed to be.

You say that there might have been some adverse reports from 

the use of these feeds in animals?

Dr. Kingma. No, we know of no——■

Mr. Carter. From human consumption.

Dr. Goddard. I would have to go to the literature for the citations, 

Doctor. These are extremely rare, involving individuals, more in the 

area of sensitivity. Reports from allergists, for example.

Mr. Carter. My observations have been tha t penicillin causes 

more reactions and dangers than any of the other antibiotics.

Many, many livestock feeders are sold on this and they say they 

get a greater gain of weight per unit of feed and per unit of time.

Thank you, Mr. Chairman.

Mr. J arman. Mr. Springer?

Mr. Springer. Just this question, Mr. Goddard. You have now 

transferred the former Division of Veterinary Medicine and made 

a bureau out of it?

Dr. Goddard. Th at is correct.

Mr. Springer. And you have transferred the veterinary personnel 

handling certifiable antibiotic applications, previously assigned to 

the Division of Antibiotic and Insulin Certification, are now located 

in the Bureau of Veterinary Medicine. How many scientific men do 

you have, roughly?

Dr. Goddard. Dr. Kingma?

Dr. Kingma. There are 44 veterinarians. I think there are six or 

seven chemists, and we have three people working in our Science 

Information Office.

Dr. Goddard. Approximately 50.

Mr. Springer. About 50 people in the scientific field?

Dr. Goddard. Yes.

Mr. Springer. How long does it take you from the time an application is filed until roughly you are ready to approve or disapprove it?

Dr. Goddard. Are you speaking about an animal drug?

Mr. Springer. Yes.

Dr. Kingma. We have been quite successful during the last year. 

Industry has withheld contacting us for a period of 90 days after 

they submit what they feel is a complete application. We have 

promised them that they will get, and they are getting, a reply at 

the end of 90 days.
28 ANIMAL DRUG AMENDMENTS OF 19 67

Mr. Springer. In other words, you are trying to work this on a time 

basis so tha t people know what you are doing and what they can 

expect?

Dr. Kingma. We have no applications in our shop now over 180 

days, which is the statutory time.

Mr. Springer. We put 180 days’ limitation.

Dr. Goddard. Th at’s the statutory limitation, Mr. Springer.

Mr. Springer. Tha t was put in there for a definite reason long 

before you came to the Bureau, the stuff had been going on for years. 

Is your personnel adequate? This 50?

Dr. Kingma. 1 think they are being handled satisfactorily.

Mr. Springer. All right. 1 think this is awfully im portant, to be 

sure th at when you get an application something is done about it. The 

only complaints I have heard in the past were, they didn’t get to the 

application for so long a stretch.

Thank you, Mr. Chairman.

Mr. Nelsen. Mr. Chairman?

Mr. Jarman. Mr. Nelsen.

Mr. Nelsen. I have the letter here from our Minnesota Commissioner of Agriculture, which I will give to you and you may provide 

us a response to his letter.

Glancing through it, it would appear to me that he is talking about 

food and drug laws of the land, not particularly what this bill does. 

But I think an answer to it would be good for the record.

(The correspondence referred to, and Dr. Goddard’s reply, follow:)

H o u se of R e p r e s e n t a t iv e s,

C o m m it tee on I n ter st a t e an d F o r eig n C o m m er c e,

Washington, D.C., October 4> 1967.

Dr. J am es L. G od dard ,

Commissioner, Food and Drug Administration,

Washington, D.C.

D ea r D r . G odd a rd: During the hearings yesterda y morning on II.It. 3639, I 

mentioned some correspondence I had received concerning this legislation. I am 

enclosing dra ft amendments to the bill suggested in this correspondence, with 

explanations thereof also contained in the correspondence, and would appreciate 

your comments concerning these amendments.

1. (a) In subsection (ii) on page 3 line 10 add a fter “section” a semi-colon and or (6) Add a new subsection (iii) on page 3 at line 11 as follows:

(m) has been approved to receive and!or use such drug by other appropriate

agency acceptable to the Secretary.

2. (a) In subsection (a)(3 )(b), (page 4 line 9) add to (1) to make it read:

(1) Full reports of investigations which have been made to show whether 

or n ot such drug is safe a nd effective for use, including, if intended for animal

feed use, determinations that the drug remains uniformly dispersed and stable

under ordinary conditions of animal feed manufacture, shipment, storage and use;

(6) Also in th at subsection add a new subsection (8) (page 5 line 4) as follows:

(8) a description of practicable methods for determining the quantity of such 

drug in animal feed; and

(c) Th at old (8) be made (9).

3. In subsection (m)(2) (page 16 line 19) change ninety to thirty.

4. In Section 106 (page 28 line 10) add to the end of the section at line 16 to 

make it read :

. . . Act, unless the use or intended use of the new animal drug or animal

feed complies with the laws of the country in which the new animal drug or

animal feed is to be used.

The purpose of 1 above is to provide enabling autho rity for the transfer of all 

or part of the workload of new drug approvals to the U.S.D.A. or to the State 

Feed Control services of the various states. In the case of the states this could 

be done through the Commissions now being issued to qualified sta te personnel.

The purpose of 2 above is to require proof from the man ufacturer of the drug
ANIMAL DRUG AMENDMENTS OF 196 7 29

mat er ia l th a t it is st ab le an d reco ve ra ble by a pr ac tica l co nt ro l assa y in th e 

an im al feed wh en t he d ru g is us ed in ac co rd an ce w ith or di nar y feed m an ufa ct uri ng 

pr oc ed ur es , in clud ing fo rm ul at io n and pe lle tin g. The pu rp os e of 3 ab ov e is to sh or te n th e all ow ed pr oc essin g tim e of a feed 

m an ufa ctu re r’s N .D .A . (New D ru g App lic ation) to a mo re re as on ab le th ir ty (30) 

da ys . T he pu rp os e of 4 ab ov e is to per m it th e ex po rt of dr ug s and an im al feed s 

co nt ai ni ng drug s as long as th ey comply w ith th e law s of th e co unt ry to which 

th ey are sh ippe d. In ad di tion , I am enclo sin g as att ach m en t A, ex ce rp ts from a le tt er discus sing 

th is leg islatio n, an d wou ld ap pre ci at e yo ur co m m en ts co nc erning th e m att ers 

disc us sed in th e ex ce rp ts from th is le tter . As yo u kn ow , I am one of th e sp on so rs of th is leg islatio n which pr op os es a 

co ns ol id at io n of ex istin g law s. To th e exte nt th a t prop os ed am en dm en ts wo uld in tr oduce new an d co nt ro ve rs ia l co nc ep ts th a t m ig ht jeop ar di ze pa ssag e of th e 

bil l, I wou ld oppo se th em a t th is tim e. You r co m m en ts on th es e prop os als wou ld 

th er ef or e be quite he lpfu l to me in det er m in in g w he th er to su ppor t or op po se 

th es e prop os als a t th is tim e.

Sin cerely yo urs, A n c h er N e l s e n .

Att ac hm en t A

P erh ap s it is n’t en tire ly co rrec t to sa y th a t 1 ha ve not come up with a new 

ar gum ent. I ha ve ha d th e ad ditio nal th ought th a t if th e sm all fee d co mpa nies 

ar e in co m pe te nt to ha nd le new dr ug s, th ey are eq ua lly in co m pet en t to ha nd le 

old drug s. In ot he r wo rds , th e arg um en t th a t su pp le m en ta l N D A ’s ar e re qu ired 

fro m all fee d m an uf ac tu re rs co ve rin g all fo rm ul at io ns in co rp ora ting new dr ug s 

m ust be ba se d on th e as su m pt io n th a t th es e mi lls ca nnot be tr u st ed to follow 

th e di re ctio ns for use in co rp ora te d in th e ap pro val of th e dru g itself. If th ey are 

in co m pet en t to follow th es e in st ru ct io ns an d ob serv e th e co nt ro ls ap plic ab le to 

th e ne w drug , th ey m ust be in co m pet en t to ob serv e th e co nt ro ls re qu ired for th e 

use of an old drug . The tr u th of th e m att er is th a t th e fee d m an ufa ct ure rs ba ck ed up by th e 

insp ec tio ns , co ntro ls and as sistan ce wh ich th ey rece ive from st ate auth ori ties 

ar e as co m pe te nt to use dr ug s in fee ds as ph ar m ac is ts ar e to use dr ug s in pre ­

sc ript io ns . A t leas t th e lev el of co m pe te nc e is en tire ly adeq uat e to cope w ith th e 

ac tu al ha za rd s invo lved . A no th er po in t is th a t if th e feed m anufa ct ure r is not go ing to ob serve th e 

in st ru ct io ns wh ich ac co m pa ny th e dr ug an d is not go ing to ob serve th e go od 

m an uf ac tu ri ng pr ac tice s es ta bl ishe d bot h by th e FD A and by st ate agencie s, 

th er e is no th in g in th e re quir em en t th a t he ob ta in an N DA th a t will assu re his co mplianc e ei th er w ith th e NDA or with th e st andard s of go od pr ac tice or with 

th e in st ru ct io ns on th e lab el. The mor e I st udy t his whole t hi ng , th e more I am im pres se d w ith th e ar gum en t 

th a t th e under ta kin g to es ta bl ish a se pa ra te su bje ct of re gu la tion kn ow n as 

“ Ne w Animal D ru gs ” sh ou ld be ac co m pa nied by a sin cere effort to wo rk out a 

co ns tr uct iv e ac co m m od atio n be tw ee n st ate and fe de ra l re gu la to ry officials. T he 

re qui re m en t th a t fee d m anufa ct ure rs ob ta in a su pp le m en ta l NDA fro m FD A is 

not su ch a sin cere and re al istic ac co m m od atio n. I t is, in fa ct , a step to co nv er t 

st ate ag en cies in to su pe rn um er ar ie s wh o ha ve no useful fu nc tion to pe rfor m in 

th is field . * * * * * * *

W he n su pp or te rs of th is bill sa y th a t it does not do an yth in g mo re th an cod ify 

ex istin g law ap pl ic ab le to new an im al drug s, th ey are not be ing en tire ly ca nd id . 

The re ha s be en no af firm ativ e re qu irem en t th a t feeds as su ch in co rp or at in g new 

di ugs m us t be co ve red by a su pple m en ta l N D A if th ey are to be sh ip pe d in in te rst ate co mmerc e, an d th er e ce rtai nly ha s be en no re quir em en t es ta bl ishe d by 

Co ng res s th a t a new dr ug sh all be de em ed un safe if it is sh ip pe d by th e m an uf ac ­

tu re r to a feed mill w ithout th e dr ug m an ufa ct ure r first ob ta in in g proo f th a t th e 

feed mill is th e ho lder of a su ppl em en ta l N D A fro m Fo od and Dru g. Thi s is, of 

course, th e prov isi on which fin all y slam s th e do or in th e fac e of st ate re gu la to ry 

officials and for ces th e sm allest feed m anufa ctu re r to ap pl y fo r a su pple m en ta l 

N D A to th e Fo od an d D ru g A dm in istrat io n. Ac cordi ng to ou r an alys is of th e bill, it will vir tu al ly pro hib it th e ex po rt of 

new an im al drug s or feed s co nt ai ni ng new an im al dr ug s as it undert akes to give 

ex tr a-t err it ori al effect to th e su pp le m en ta l N D A re qu irem en t. A ppar en tly th e

85—41 9— 67------5
30 ANIMAL DRUG AMENDMENTS OF 196 7

N at io nal Fe ed M an ufa ct ure rs Assoc iatio n ag rees w ith us on th is be ca us e it is 

re port ed th a t th ey ha ve ob je ct ed to th os e prov isions of th e bill per ta in in g to th e 

ex po rt of ne w an im al dr ug s and feed s co nt ai ni ng new an im al dr ug s.

D ep ar tm en t of H ea lt h, E du ca tio n, and W elfa re,

F ood and D ru g Adm in is tr at io n,

Wa shing ton , D.C., October 19, 1967. Hon . Anc he r N els en ,

Sub com mittee on Public Health an d Sa fety , Committee on Inter sta te an d Foreign

Commerce, House of Representati ves, Washin gto n, D.C.

D ea r M r. N e l sen: Th is is in resp on se to y ou r le tt er of O ctob er 4, 1967, re ques ting co m m en t on ce rtain dra ft am en dm en ts to H .R . 3639 pr op os ed in co rres po nd ­

enc e re ce iv ed by yo u co nc erning th is bill.

In the ligh t of the con side ra tion s s et fo rt h in t he en clo sed m em or an du m , I ca nno t 

re co m m en d ad op tion of th e d ra ft am en dm en ts . I wou ld, th er ef or e, su gg es t th a t 

th is bill, which ha s been th e su bj ec t of su ch ex te nd ed co ns id er at io n, be en ac te d 

in its pr es en t form .

Sinc erely yo urs,

J ames L. God da rd, M .D ., 

Comm issioner of F ood an d Dru gs.

Mem or an du m

COM M EN TS ON D R A FT A M EN D M EN TS TO H .R . 3639

1. The first dra ft am en dm en t wou ld in se rt on pa ge 3, below lin e 10, of th e bi ll 

an ad ditio nal cla us e (iii) as follow s:

“ (iii) ha s be en appr ov ed to rece ive and/o r use su ch dr ug by oth er app ro ­

pri ate ag en cy ac ce pt ab le to th e Secre ta ry .”

Accordin g to th e co m m en ta ry tr an sm it te d with Con gr es sm an N else n’s le tter , 

th is am en dm en t wo uld ha ve th e pu rp os e of au th or iz in g th e D epart m ent of H EW 

to tr ansf er all or p art of th e wor kloa d of “new an im al dru g” ap pro va ls to th e 

U. S. D ep art m ent of A gr ic ul tu re or to th e S ta te feed co nt ro l service s of th e 

va riou s Sta te s. A no ther p a rt of th e co m m en ta ry see ms to su gg es t th a t th e en tire 

re quir em en t of ap pro va l of an an im al feed ap pl ic at io n, co nt ai ne d in th e bill, is 

un ne ce ss ary. W ith th is we ca nnot ag re e; th e o mission of such a re quir em en t wo uld 

ch an ge dr as tica lly th e wh ole pu rp os e of th is bil l and redu ce th e pu blic pro te ct io n 

affo rd ed by ex istin g law .

T he se nt en ce whic h A m en dm en t No . 1 wo uld am en d mor eo ve r, is in te nde d 

mer ely to insu re th at, as es se nt ia lly re qu ired unde r ex istin g regu la tio ns , th e 

m anufa ct ure r, pa ck er, or dis tr ib uto r of a new an im al dru g fo r use in th e m an uf ac ­

tu re of an im al fee d ship th e dr ug on ly if he ha s no tice fro m th e Sec re ta ry , or ha s 

fro m th e co nsignee a w ri tt en st ate m ent, to th e eff ect th a t th e consigne e ei th er is 

himself a ho ld er of an appr ov ed a nim al feed ap pl ic at io n w ith re sp ec t to th a t dr ug 

or th a t th e consign ee will, if not himself a us er of th e dr ug , sh ip th e dr ug on ly 

to a ho ld er of an ap pr ov ed an im al feed ap pl ic at io n. In th e ab se nc e of th is ke y 

pr ov ision of th e bill o ur p oli cin g job w ou ld b ecom e vast ly m ore dif fic ult a nd c os tly .

We ar e in ag re em en t w ith th e su gg es tio n th a t we m ak e incr ea sing use of th e 

co m pe te nc e and service s of S ta te feed co nt ro l ag en cies in th e disc ha rg e of ou r 

ow n resp on sibi lit ies, an d we are now do ing so and in te nd to do so in increa sing 

m ea su re under ex istin g auth ori ty .

2. T he seco nd su gg estio n tr an sm it te d by Mr . Ne lse n is to am en d prop os ed 

Sec. 51 2( b) (1 ) (pa ge 4, lin es 9-11 ) of th e bil l to re ad as follow s:

“ (1) full re port s of in ve st ig at io ns which ha ve be en m ad e to show w he th er 

or not su ch dr ug is safe an d effecti ve for use, includ ing, i f in ten ded for an im al feed use, determ ina tions that the dru g rema ins un ifor m ly disper sed an d stable

un de r ordina ry conditio ns of an im al feed man ufa ctu re, sh ipme nt, storage an d

us e; ” (N ew m att er is ita lic ize d.)

Thi s am endm ent is un ne ce ss ar y be ca us e we ar e re qui ring under ex istin g law , 

and wou ld co nt in ue to re quir e un de r Sec. 51 2( b) (1 ), th a t th e re port s of in ves tigation in cl ud e su ch data . We are, ther ef or e, n o t co m m en ting up on th e te ch ni ca l 

ad eq ua cy of th e pr op os ed am en dm en t.

3. Thi s am en dm en t wou ld re nu m be r clau se (8) of th e pr op os ed Sec. 512(b) as 

cla use (9) an d wou ld in se rt th e following ne w cla use (8):

“ (8) a de sc ript io n of pr ac tica ble m et hods for det er m in in g th e q u an ti ty 

of su ch dr ug in an im al fe ed ;”
ANIMAL DRUG AMENDMENTS OF 1967 31

This am en dm en t wou ld duplica te th e bro ad er prov ision, now in th e bill, of 

clau se (7) of Sec. 512(b) which re qui re s “a des cr ip tion of pra ct ic ab le m et hod s for 

de te rm in in g th e q u an ti ty , if an y, of su ch dr ug in or on foo d, an d an y su bst an ce 

fo rm ed in or on foo d, be ca us e of its use ” . T he te rm “fo od ” , as us ed in th is cla us e 

(7) , in clud es by de fin ition not on ly food for hu m an s, b u t als o an im al fee d. Thus 

th e pr op os ed am en dm en t wou ld be du pl ic at iv e.

4. T he nex t am en dm en t pr op os ed wou ld sh ort en from 90 to 30 da ys th e m ax im um tim e pe riod which th e bill all ow s th e D epart m ent fo r ap pr ov in g or dis ap ­

pr ov in g th e ap pl ic at io n of a feed m anufa ct ure r unde r Sec. 512(m ) of th e bil l. We 

ar e st ro ng ly op po se d to th is ch an ge . Whil e we ar e m ak in g ev er y effo rt to arr iv e a t 

a de cision in as sh ort a tim e as po ssible an d hav e so im pr ov ed ou r efficie ncy in 

th is re sp ec t as to dis po se of feed m anufa ctu re rs ’ appl ic at io ns w ithin 45 day s on 

th e av erag e, some ap pl ic at io ns invo lv e spec ial pr ob le m s which in ev itab ly re quir e 

ex te nde d tim e an d co ns id er at io n. Of ne ce ss ity , a tim e lim it sh ort er th an th a t now 

in th e bill wo uld , in th e ab se nc e of an ex tens ion ag re ed to by th e ap plica nt, of te n 

ha ve to re su lt in di sa pp ro va l of th e appl ic at io n whe re th e avai la bility of a long er 

pe riod m ig ht ha ve re su lted in ap pr ov al .

5. T he ne xt am en dm en t pr op os ed wou ld ch an ge Sec. 196 of th e bill so th a t a 

new an im al drug , or an an im al feed be ar in g or co nt ai ni ng su ch a drug , which is 

un sa fe w ith in th e m ea ni ng of th is bill, co uld nev er th el es s be ex po rted so long as 

th e “use or i nte nded u se ” of th e d ru g or fee d co mplies w ith th e law s o f th e c ountr y 

in w hich th e dr ug or feed is to be used . Thi s wou ld serio us ly un de rm in e th e p ub lic 

pro te ct io n affo rd ed un der ex istin g law and wou ld, ther ef or e, be obj ec tionab le .

(For further comment, see FDA letter dated November 1, 1967, p. 

66.)

Mr. Nelsen. I might also comment, Mr. Chairman, that 1 see our 

former colleague, Iven Roberts, here in the room. He and 1 worked 

on this bill when he was the chairman of this subcommittee. He’s my 

turkey-hunting friend and I want to express my welcome to him.

Mr. Roberts. The turkeys are waiting now. [Laughter.]

Mr. Nelsen. Thank you, Mr. Chairman.

Mr. J arman. Let the Chair add tha t it had every intention of 

recognizing the presence of our distinguished colleague who led this 

subcommittee through such a progressive record of legislation in the 

field of human and animal health.

Mr. R oberts. Thank you, Mr. Chairman.

Mr. J arman. Mr. Rogers?

Mr. Rogers. Thank you. 1, too, am delighted to see our former 

chairman and colleague here. His interest is still being evidenced in 

the legislation the Congress is considering because of his work over 

the years.

Dr. Goddard, it’s good to see you and your associates.

About what is the time element for approving a new animal drug 

now?

Dr. Goddard. Well, we do not have any, as Dr. Kingma indicated, 

tha t are more than ISO days old. The average, I would say, is somewhere around 130-140 days.

Dr. Kingma. Yes, 1 think so. We make every attempt to get an 

answer to them within 90 days.

Dr. Goddard. Obviously the average is influenced greatly by the 

more complicated ones. The simpler ones are well within a 90-dav 

period.

Mr. Rogers. I see. I understand, too, that you have worked out a 

pretty good understanding with the industry so that they are now 

submitting more complete information, so that you don’t have to go 

back.

Dr. Goddard. This is correct. The submittals have improved in 

quality in the past year.

Mr. Rogers. I notice you say tha t in decisions concerning food 

additives, you have worked out a liaison between the Bureau of 

Science and the Bureau of Veterinary Medicine?
32 ANIMAL DRUG AMENDMENTS OF 1967

Dr . Goddard. Yes, sir.

Mr. R ogers. Explain th at to me quickly.

Dr. Goddard. Well, the toxicologists and pha rma colo gists in the 

Bureau of Science review food addit ive petitions. One of the things 

food additive s become involved with is the use of a chemical in 

animals which later is going to becom e hum an food. 'There has to be 

close coordin atio n and un derst an ding on the part of both the Burea u 

of Ve terina ry Medicine and th e Bureau of Science, of the anim al 

physiology, what the feeding practic es are, what ration al approach 

would be in term s of withh old ing of the use of the chem ical for x

numb er of days prior to slaughte r, if that is involved.

So we hav e se t up a mechanism whereby these petitio ns are reviewed 

by bo th burea us and the re is am ple op po rtu nity for discussion between 

the scientists of these burea us before app rov als are given.

Mr. R ogers. But this is still within the 180-day period?

Dr. Goddard. Yes, sir.

Mr. R ogers. Has the re been any new dev elopment as to time 

elem ents and so forth in you r con sideration of pro tection of meat, 

milk , and eggs, derived from anim als used?

Dr . Goddard. Well, we have some thorny problems to settle there.

1 wish the y would go away, bu t the y are not going to. One of them 

related to use of streptom ycin. 'The pers istence of str eptom ycin is 

great er for longer periods of time tha n we had here tofore expected.

For example, the kidney s seem to be a prim e target org an; one 

where the dru g rem ains for a long er period of time .

Mr. R ogers. Streptom ycin is given basically for what?

Dr . Goddard. Well, it ’s given for a numb er of conditio ns. In cows 

J thi nk i t’s given for lum py iaw, and I ’ll let D r. Kingma answer that, 

because I hav e run ou t of expertise.

Dr. K ingm a. The usu al trea tm en t is an injectio n of penicillin and 

streptom ycin. It no do ub t is the most widely used inje ctable an tibiotic in the anim al industry. It will comb at most any t yp e of sys temic 

infection.

Mr. R ogers. So you are hav ing to decide how long before the 

sla ughte r of th e anim al th at you may use this drug?

Dr. Goddard. Th at is c orrect.

Mr. R ogers. Well, you certainly wou ldn’t wa nt to have the drug 

make people ill, so you hav e to decide aft er the c ure how long it mu st 

be; is th at it? Is this period havin g to be extend ed or what?

Dr. Goddard. This is wh at we are looking at. Has the re been any 

publication on that?

Dr. K ingm a. Not as y et. 'There will be shortly , to ale rt the ind ustry 

of the prob lem.

Dr. Goddard. We are stu dy ing now, Con gressm an Rogers, what 

the approp ria te tim e period shou ld be a fte r use of the dru g.

Mr. R ogers. This depend s on the owner of the animal in giving 

the dru g— the directions?

Dr. Goddard. A great deal is dep end ent upon the veterinar ian s 

who are involved, who work with feedlot ope rato rs, for exam ple, 

and the feed lot opera tors them selves. 'This is an are a w here the y have 

to exercise a degree of responsibility in the use of thes e antibio tics .

Mr. R ogers. And briefly, wh at is the pro ced ure for checking 

wh eth er the drugs were given within this period or not? A tes t of the 

anim al’s own residue or what?
ANIMAL DRUG AMENDMENTS OF 1967 33

Dr. Goddard. After the animal is slaughtered and the meat is 

being processed, the U.S. Department of Agriculture carries out certain 

laboratory tests as we do also—and this is done with full knowledge of 

each other and understanding of what our programs are. EDA also 

samples meat and meat products for residue.

Mr. Rogers. You say Agriculture does this, too, for the same items?

Dr. Goddard. Yes. Of course we are not duplicating each other’s 

effort, because neither one of us is sampling the same carcasses, but 

rather we are working in different parts of the country----

Mr. Rogers. So you have coordinated your effort.

Dr. Goddard. I personally met with Assistant Secretary Mehren 

and members of his staff and members of my stafl to make sure we 

are working closely together. As you realize, our present Director of 

Veterinary Medicine came from the Department of Agriculture, ARS, 

so it has made the coordination much easier than otherwise might be.

Mr. Rogers. Thank you, Mr. Chairman.

Mr. Carter. Mr. Chairman, I believe you stated that streptomycin 

persisted for quite a while after injection, in the kidney. Again, what 

ill effects result from use of such a kidney as good, animal products? 

Are you acquainted with any effect it might have?

Dr. Kingma. No; but I think our duty is certainly not to permit 

adulterated food, and if this results in adulterated food I think we have 

a definite responsibility.

Dr. Goddard. Beyond that, Dr. Carter, the scientific community 

has expressed its concern. There was a meeting which we cosponsored 

recently. I will be happy to provide you with a report of this. At this 

meeting the outstanding scientists in veterinary medicine came 

together under the aegis of the National Academy of Sciences, to 

discuss this problem. A growing concern was brought forth at this 

meeting for unnecessary usage—I think would be a lair way of 

stating it—and for developing better procedures to assure tha t the 

products entering the marketplace carry a minimum of these kinds of 

residues. I think this is comparable to the pesticide residue problem we had 

in the past. We have been able through cooperative efforts on the 

part of the U.S. Department of Agriculture, the county agents, the 

growers and the industry involved to markedly reduce the pesticide 

residues on foodstuffs entering the marketplace. Now, the same kind of effort is and has been underway with the 

people involved with animal products and I am simply expressing a 

concern that we continue tha t effort and tha t we not unnecessarily 

burden our meat products in the marketplace with these kinds of 

drug residues.

Mr. Carter. Certainly I appreciate the efforts made toward 

pesticides. We have just seen the result of some of that in Tijuana, I 

believe, but again, small amounts of streptomycin within a kidney 

might or might not cause bad results, but at the present time we 

know of no ill effects from it. Of course, injection of streptomycin, 

injections do cause different things—deafness, for instance -and 

different things like that, but I should think in such minute quantities 

such as they might appear in the kidney, there would be little eflect, 

if any, from it; possibly a sensitization. But we don’t know th at it causes any effect. Here we are legislating 

against something tha t may cause something or may not. On the 

other hand, it might be extremely helpful. We do know that strepto-
34 ANIMAL DRUG AMEN DMENTS OF 19 67

my cin is used again st tuberculosis, has been, and it has been one of 

our most effective drugs, and it would be extr emely im po rta nt to 

hav e a portio n of this in animal foods to insu re its pa latability and 

freedom from bovine tuberculosis.

Of course, it we go to jum pin g at so ma ny thin gs an ani ma l eats, 

alm ost a ny s ort of food, an y type of food, and ma ny of the substances 

from which thes e drug s are mad e are pro bably in its diet. We are 

really nit -picking ju st a little bit, I ’m afra id, witho ut knowing the 

reason for doing these things.

Tha nk you, Mr. Chairm an.

Mr. Nel se n. Mr. Chairma n, an othe r question.

In the case of 2 4-D for app lication on pastu res , for exam ple, I know 

of a case recentl y where an overa pplication was made and four anim als 

died as a res ult. Now, would the residue in an animal of th at kin d 

rem ain for a great, leng th of time?

In the case of other anim als th at did not die, they certa inly would 

have a toxic conte nt in their sys tem , wo uld n’t they?

Dr. Ivingm a. This is one of the items which does rem ain in animal 

tissues, especially the fa tt y tissues, for treme ndous periods of time.

Dr. Goddard. Tt is simila r to D D T in rem aining in the fa tt y tissues.

Mr. N el se n. I s this a common occurre nce in the use of pastu re 

spr ay? I n ever hea rd of it before. Th is hap pen ed on my farm , actua lly. 

Th e fellow th at was tak ing care of the herd put an ove rdose on the 

pa stu re with a fairly good gro wth in a dry period of time .

Dr. Goddard. It is a bro ad-leaf cover as I recall, and I think there 

has been a grea t growth in the sop histication and un derst andin g of 

farm opera tor s and how to use these, largely thr ough the agric ult ure 

exte nsion agent s; the co un ty age nts hav e been instr um en tal in pro ­

viding good inf orm ation on people on the use of insecticides, pesticid es, 

and herb icid es in partic ula r.

Mr. Nel se n. Th an k you.

Mr. Car te r. Mr. Ch airma n, we might be missing our proper 

mode of a tta ck . I certa inl y think it shou ld be aime d tow ard pesticides 

and things of th at natur e. Th ey offer a greater pos sibility of harm to 

hu ma ns th an minu te qu an tities of drugs, I would think , and from 

the bre ad situation in Tijuan a, why, certa inly it has been bro ugh t 

to our attentio n. And, again, ove ruse of pesticides is destroying our 

birdla nd. Ce rta inly we should ha ve som eth ing alon g th at line, I 

should thi nk.

Mr. R oge rs. Mr. Chairma n?

Mr. J arman. Mr. Rogers.

Mr. R oge rs. Ju st pursu ing th at , doesn ’t the Dep artm en t of 

Agricu lture check this matter?

Dr . Goddard. Yes, we also check pes ticide levels throu gh our 

marke t survey s. We purch ase food at variou s superm ark ets in the 

com munities in which our distr ict offices are located, and tes t for 

pes ticide levels.

Mr. Roge rs. So this is checked ju st as much as a dru g resid ue?

Dr . Goddard. Yes, sir.

Mr. R oge rs. I was un de r the imp ression this was done.

Dr . Goddard. Yes, sir.

Mr. Carter. I ’m tha nk ful this is being done.

Dr . Goddard. We have seen an im pro veme nt in this area.

Mr. R oge rs. Th an k you.
ANIMAL DRUG AMENDMENTS OF 196 7 35

Mr. Jarman. Mr. Skubitz?

Mr. Skubitz. No questions.

Mr. Jarman. Dr. Goddard, we appreciate you and your associates 

being with us this morning.

We would now like to ask our colleague, Mrs. Dwyer from New 

Jersey, to introduce our next witness this morning.

STATEMENT OF HON. FLORENCE P. DWYER, A REPRESENTATIVE 

IN CONGRESS FROM THE STATE OF NEW JERSEY

Mrs. Dwyer. Mr. Chairman and members of the subcommittee, 

it is my pleasure and honor to appear today before the subcommittee 

to introduce D r. Luther S. Roehm.

Dr. Roehm is this year’s president of the Animal Health Institute, 

and is vice president and general manager of Merck Chemical Division, 

Merck & Co., Inc., Rahway, N.J.

He has a long record of achievement in the animal health industry. 

Formerly with Dow Chemical Co., and a vice president of A. E. 

Staeley Manufacturing Co., Dr. Roehm joined Merck in 1961. He 

presently directs marketing operations and services for the company’s 

industrial and fine chemical products, and animal health and feed 

products.

Dr. Roehm received his B.A. and M.A. degrees from Indiana 

University, and his Ph. D. from the State University of Iowa. He is a 

director of the National Vitamin Foundation. He is also a member of 

numerous professional and scientific organizations—among them, the 

American Chemical Society, the American Association for the Advancement of Science, and the Institute of Food Technology.

Dr. Roehm is eminently qualified as a representative of the animal 

health industry to testify a t this hearing on H.R. 3639.

May I present Dr. Luthe r S. Roehm to the chairman and the members of the subcommittee.

Mr. Jarman. Thank you very much, Mrs. Dwyer. We will be 

pleased to hear Dr. Roehm.

STATEMENT OF DR. LUTHER S. ROEHM, PRESIDENT, ANIMAL

HEALTH INSTITU TE; ACCOMPANIED BY JOHN M. HOLT, MEMBER, LEGISLATIVE COMMITTEE

Dr. Roehm. Thank you, Mr. Chairman and Mrs. Dwyer.

Mr. Chairman and members of the subcommittee, I would like to 

indicate I live in New Jersey and the district which Mrs. Dwyer represents. We are proud of her record and performance over the years, as 

is evidenced by her appearance here and her interest in this bill.

Thank you again, Representative Dwyer.

I would like to comment, too, I lived in Bill Springer’s district in 

Illinois. I ’m sorry I didn’t get to speak to him. The last time I was 

with Mr. Springer we were at an Illinois football game.

Mr. Jarman. You could add tha t in the past and the present you 

are well represented here in Congress.

Dr. Roehm. Thank you, Mr. Chairman and members of the subcommittee. Accompanying me on my right is Mr. John Holt, attorney 

and member of the Legislative Committee of the Animal Health Institute. Mr. Holt and other members of tha t committee are prepared to
36 ANIMAL DRUG AMEN DMENTS OF 196 7

supplement my statement should you or other members of this subcommittee have any questions of a legal or technical nature.

I might add, Mi-. Holt has been deeply involved in this bill for the 

last 2 or 3 years.

T am Luther S. Roehm, vice president and general manager of 

Merck Chemical Division of Merck & Co., Inc., Rahway, N.J. Among 

other things, our company is engaged in the manufacture and sale of 

animal health products tha t include biologicals, feed additives, and 

veterinary pharmaceutical products.

I appear before this subcommittee as a director and president of 

the Animal Health Institute in support of H.R. 3639. The institute 

was organized in 1941. Its membership includes more than 40 manufacturers which account for over 90 percent of the production of 

animal health and nutrition products manufactured and sold within 

the United States.

On behalf of the Animal Health Institute, 1 shall comment on the 

salient provisions and inten t of H.R. 3639.

Within the past two decades the development by members of the 

Animal Health Institute and others of veterinary pharmaceutical 

preparations, biological products, and feed additives has contributed 

enormously to animal disease control. These developments have helped 

improve the quality of farm products of animal origin and have played 

a vital part in providing consumers with an abundance of wholesome 

meat, poultry, eggs, and dairy products.

Despite these improvements, the struggle for more efficient production goes on, and the battle against the ravages of disease and 

economic loss due to disease, parasites, and nutritional deficiency is 

not y et won.

H.R. 3639 was introduced in the 90th Congress by the chairman of 

this subcommittee in J anuary 1967, after its predecessor, H.R. 16474, 

passed the House unanimously last year near the close of the 89th 

Congress. Due to lack of time Senate hearings could not be scheduled 

for H.R. 16474.

With one exception, H.R. 3639 is identical to H.R. 16474, the difference being that the former provides for an effective date 12 months 

rather than 6 months after enactment. This difference is acceptable to 

industry, and I understand it is likewise acceptable to the Food and 

Drug Administration.

H.R. 16474 was introduced and passed the House as a result of 

hearings on H.R. 7247 conducted by this subcommittee’s predecessors 

in the fall of 1963, and on H.R. 7655 in June 1966. During those hearings substantial evidence of the need for modification of the basic act 

was presented. Witnesses described the untoward delays in the processing of applications, the duplicate and triplicate requirements, and the 

difficulties encountered by the Food and Drug Administration and the 

industry in premarketing clearance procedure required by the three 

separate sections of the act.

Members of the subcommittee and representatives of the Food and 

Drug Administration offered suggestions for improving H.R. 7247 

and H.R . 7655. During the 88th and 89th Congresses, the Animal 

Health Institu te worked diligently with representatives of the Food 

and Drug Administration, the D epartmen t of Health, Education, and 

Welfare, and the Committee on In ters tate and Foreign Commerce to 

make those suggestions acceptable to Government, the health profes-
ANIMAL DRUG AMENDMENTS OF 19 6 7 37

sions, and industry. They were largely incorporated by way of amendment in H.R. 16474, and presently appear in H.R. 3639.

The purpose of H.R. 3639 is to consolidate the provisions of the 

Food, Drug, and Cosmetic Act relative to the premarketing clearance 

of new animal drugs into a single section of the statute specifically 

designed for such drugs. This purpose will be achieved without reduction in the rigid controls contained in existing law to safeguard the 

public health. H.R. 3639 is designed—

(1) To consolidate the duplicate and triplicate controls currently imposed by sections 409, 505 and 507 of the act;

(2) To create a single statutory standard of safety and effectiveness for animal drugs in a new section 512, thus elevating such 

drugs to a position equal to tha t of drugs and antibiotics for 

human use and of human food additives;

(3) To establish a realistic statuto ry mechanism for the premarketing clearance of new animal drugs and of animal feeds 

bearing or containing them;

(4) To provide appropriate controls over animal drug manufacturers and over feed manufacturers using such drugs;

(5) To prevent recurring delays in the introduction of new 

animal drugs and to facilitate their availability to the producers 

of livestock and poultry following discovery and development; 

and

(6) To retain all safety and efficacy requirements provided for 

in the existing act.

Fundamental to any consideration of H.R. 3639 is the realization that 

when the Federal Food, Drug, and Cosmetic Act was enacted in 1938, 

the number and type of drugs which were being marketed for use in 

animals were greatly different from those available today.

As a matter of fact, the medicated feed industry, as we know it, 

did not exist in 1938. The practice of veterinary medicine has also 

changed dramatically. As a result, there is today a confusing and 

unwieldy regulatory structure for animal drugs which may subject 

them to three separate statuto ry procedures before they can obtain 

marketing clearance.

The chief objective of legislation in the drug area has been to 

regulate drugs for human use. From the Food and Drug Act of 1906 

through the Food, Drug, and Cosmetic Act of 1938 and its subsequent amendments, human drugs have been the prime consideration. 

The result is tha t the statute clearly establishes the procedures for 

handling human drugs. While animal drugs have always been regulated under the act, they have received stepchild treatment at best, 

particularly in the promulgation of regulations which, while covering 

human drugs in detail, frequently mention animal drugs almost as 

an afterthought.

The bill before this subcommittee gives Congress the opportunity 

to express its intent with respect to animal drug clearances. It would 

solve the problem of multiple controls by consolidating into a single 

new section the diverse and overlapping clearance sections of the 

present Food and Drug Act, now applicable to animal drugs.

This section is designed specifically for the effective and efficient 

regulation of these products. The desirability of this approach to the 

processing of new animal drug submissions has been recognized by the
38 ANIMAL DRUG AMENDMENTS OF 196 7

Food and Drug Administration in its reorganization and in the elevation, near the end of 1965, of the Division of Veterinary Medicine to 

bureau status. This bureau has been under the direction of very 

capable administrators, initially Dr. M. R. Clarkson, who is now the 

executive secretary of the American Veterinary Medical Association, 

and currently Dr. C. D. Van Houweling, who is, I must say, doing a 

fine job.

In recent years the growing world population and food crisis have 

received an increasing amount of attention. Congressional committees have heard testimony tha t the end of our agricultural surpluses is in sight and that the exploding world population is eating its 

way toward a food crisis of fantastic proportions.

In this connection, I would particularly commend the statement of 

Dean Earl L. Butz, dean of agriculture, Purdue University, which 

appears in the hearing record on H.R. 7655, pages 59-64. I would also 

like to submit a copy of his statement for the record in this hearing.

(See attachment 1, p. 39.)

Dr. Roehm. A great many suggestions have been made for the 

relief of the impending massive food problem. Aside from the approach 

of preventing or ameliorating it by decreasing the birthrate, most of 

the suggestions involve increasing food production, and more specifically, improvement of bo th quantity and quality of the world food 

supply. Proteins are the key to the improvement of world diets.

Animal agriculture, especially the animal agriculture of the United 

States, must be prepared to produce the high-quality protein needed 

to meet the challenges of the coming decades. The animal health 

industry must play a major role in tha t effort.

We believe the provisions of H.R. 3639 will help industry and 

Government in meeting the increasing demands for the control of 

livestock losses. Livestock enterprises add more than $20 billion 

annually to the gross national product. This constitutes more than 

55 percent of the total agricultural income.

1 think it is important to mention tha t no appropriations will be 

needed to support this legislation. Indeed, it is expected tha t it will 

enable the Food and Drug Administration to increase its operating 

efficiency in the field of animal health drugs.

In conclusion, the Animal Health Institute heartily endorses and 

supports H.R. 3639 and the identical bills introduced by Representatives Rogers, Watts, Hull, Nelsen, Andrews, Downing, Landrum, 

Dwyer, Patten, Bray, O’Neal, Stephens, and Harvey.

We support these measures as constructive legislative programs 

which will advance the interest of farmers and the consuming public. 

It is highly significant th at H.R. 3639 is also supported and endorsed 

by major associations and interests in the veterinary-agricultural, 

community, such as American Feed Manufacturers Association, 

American Veterinary Medical Association, Delmarva Poultry Industries, the American Farm Bureau Federation, National Broiler 

Council, National Association of State Departments of Agriculture, 

American National Cattlemen’s Association, American Society of 

Animal Science, and others whose endorsements appear in the hearing 

record on H.R. 7655. Accordingly, it is hoped that your subcommittee 

will report favorably on H .R. 3639.

With your permission, Mr. Chairman, I would like to submit for 

the record two supporting documents. One, attachment 2, sets forth
ANIMAL DRUG AMENDMENTS OF 196 7 39

briefly the purpose, a summary, and an analysis of H .R. 3639. The 

other, attachmen t 3, explains why H.R. 3639 means more meat, milk, 

and eggs for a growing America. (Attachment 3 may be found in committee files. The information contained in this item is covered in Mr. 

Holt’s statement.)

Mr. Chairman, with your permission I would like to call on Mr. Holt 

now to continue this presentation, unless there are questions from the 

chairman or the subcommittee.

Mr. Jarman. Dr. Roehm, we will be glad to receive these submissions and to hear from Mr. Holt.

(Statem ent of Dr. Butz and other documents follow:)

A tt a c h m en t 1

(This statement, originally delivered by Earl L. Blitz, June 13, 1966, is again cited 

herewith as an att achm ent to a statem ent by Dr. Luther S. Roehm) 

S T A TEM EN T OE E A R L L . BUTZ , P H . D ., D EA N OF A G R IC U LT U R E , PU R D U E U N IV ER SIT Y

My name is Earl L. Butz. For the past eight years I have been Dean of Agricultu re at Purdue University . For thre e years prior to that, from 1954 to 1957, 

I served as Assistant S ecretary of Agriculture in charge of Marketing and Foreign 

Agriculture. Among other things, I was in charge of the Foreign Agricultural 

Service and trav eled extensively in many parts of the w’orld, studying food and 

agricultu re conditions. For eight years previously, I was head of the Department 

of Agricultural Economics and Professor of Agricultural Economics at Purdue. 

My entire professional life has placed me in close proximity with food-population 

problems, both in this country and abroad.

My inte rest in H.R . 7655, the “Animal Drug Amendments,” is the inte rest of 

an agricultural economist concerned with the world crisis which is developing in 

the population-food ratio. The North American food in dustry is facing its grea test 

challenge of all time, and we must exercise every opp ortuni ty to prepare to meet 

it. One such opportunity presents itself in H.R. 7655, which will eneourage the 

development of new animal drugs.

The world is on a collision course. When the massive force of an exploding world 

population meets t he much more stable trend line of world food production, something must give. Unless we give increased attention now to softening the effects 

of the impending collision, many parts of the world, within a decade, will be sk irting a disaster of such proportion as to threaten the peace and stab ility of the 

Western world itself.

The man-food ratio around the world, never high enough to be very exciting to 

two-thirds of the world’s population, has actually been in a decline the past half 

dozen years. Total food outpu t has increased during those years, to be sure, but 

at a slower rate than population increase. In m any of the world’s underdeveloped 

areas, the man-food ratio is in a serious decline.

The first claim of any society on its total production resources is to produce 

enough food to keep th e population alive and reproducing itself. Some Far Eas tern 

natio ns require 80 to 90 percent of their population on the land to get th e job done. 

In the United States we do it with less th an 6 percen t of our working popidation 

on our farms. There is room for sub stan tial expansion of food production, both in 

the undeveloped an d in the developed areas of the world, through continued a pplication of science, infusion of capital, and nonrestrictive governmental programs.

At the beginning of the Christian era, world popidation was estim ated to have 

numbered around 250 million. In the next fifteen centu ries it doubled, reaching 

500 million by 1600. Three centu ries later, by 1900, world population had tripled 

and stood at a bout 1.5 billion. In the less th an twro-th irds of a centu ry since 1900, 

world population has approxim ately doubled again and now exceeds 3 billion. 

Reliable estimates indicate t ha t, in th e little over one-third of a century remaining 

until the year 2000, it will double again and will stand at abou t 6.3 billion people.

If, from the beginning of the Christian era, we had multiplied at the present 

rate , there would now be over one million people per square foot of earth surface. 

Obviously, the rate of growth cann ot persist indefinitely, because of the sheer 

limitation of space and food. However, its frightening implications are a threat 

we must face.
40 ANIMAL DRUG AMENDME NTS OF 19 67

Fro m th e be ginn ing of his to ry , m an has alway s bee n in a stru gg le to fee d himself, w ith th e po ssible ex ce ption of th e W es te rn world in th e p ast tw o or th re e 

de ca de s. F ro m th e be ginn ing of th e hum an race unti l now , m an gra du al ly de ve lop ed t he foo d pr oduct io n c ap ac ity req ui re d t o su st ai n 3 b illion pe op le on the ear th , 

al th ough m an y m an y pe rson s ha ve a ve ry mea ge r av ai la bl e food su pp ly pe r 

ca pita. If th e 6 billi on -plus pe op le pr ed ic te d by th e ye ar 200 0 ar e to be su staine d, 

w ith no im pr ov em en t in die t w ha te ve r, m an will ne ed to de ve lop th e ca pa ci ty to 

feed an oth er 3 bi llion p eople — and th is m ust be do ne in th e sh ort te rm of o ne- th ird of 

a cen tu ry . T hi s mea ns th a t we m ust dup lica te in th e nex t gen er at io n th e pr odu ct io n re co rd th a t m an has ac hi ev ed sin ce th e da wn of his to ry . A nd we m us t 

do t h is a t a tim e whe n ne ar ly all of th e virg in la nds of the world h av e be en br ou gh t 

in to pr od uct io n and when we fac e in cr ea sing in ro ad s on ar ab le la nd by sp re ad ­

in g su burb an co mmun iti es , high way s, an d th e lik e.

The re ar e on ly tw o po ssibl e an sw ers to th e pr ob lem I ha ve po sed he re. On e is a 

w id es pr ea d an d ra pid increa se in b ir th co nt ro l pr ac tic es , wh ich , in th e long ru n— 

sa y, by th e close of th is cen tu ry — is th e on ly so lu tio n. T he se co nd — and th e 

im m ed ia te ne ed co nf ro nt in g us— is to increa se ag ri cu ltura l pro du ct io n wo rld wi de.

We m ust do ev er yth in g po ssible to ac ce le ra te th e ap pl ic at io n of ca pital an d 

te ch no lo gy to ou r ag ri cu ltur al and foo d sy stem s in an effo rt su bst anti all y to increa se o u tp u t pe r ac re an d per man . Thi s includ es ac ce le ra te d ap pl ic at io n an d 

use of fe rtilizer s, irrig at ion, b ett er seed va rietie s, more pe sticides , ne w and im ­

pr oved an im al drug s an d agri cu ltura l ch em ica ls, and ex tens ive re se ar ch ex pe nd itu re s, in cl ud in g re se ar ch to im pr ov e th e ge ne tic ca pa bi lit ies of pla nts a n d a nim als.

T he o p port unit y fo r increa se d foo d pr od uc tion o n th e N ort h A merican c ontinen t 

is trem en do us. In th e U ni ted Sta te s alon e, dis ease, pa ra site s, and in se ct s co st 

American fa rm er s alm os t $3 bil lio n each yea r th ro ug h loss of an im al liv es to ck an d 

poult ry . U rg en tly ne ed ed ar e new ag en ts to fig ht th es e co stly food losses and ad d 

to th e av ai la bl e food su pp ly . Also ho lding trem en do us prom ise fo r in cr ea sing th e 

fo od su pp ly ar e ye t-to -b e de ve lope d gr ow th st im ula nts an d fee d ad di tives wh ich 

wi ll im pr ov e th e efficie ncy of an im al pr ote in pr od uc tion .

T he N o rt h American co nt in en t, an d pr im ar ily th e U nited Sta te s, will be called 

up on w ith in th e de ca de for a mas sive ef fo rt to m ee t th e im pe nd in g crisis in th e 

wor ld po pu la tion -f oot ra tio. I t m ust be a m aj or resp on sibi lity of all of us to ke ep 

ou r nati onal fo od -p rodu cing m ac hi ne hea lthy and efficient. We m ust st re ngth en 

pu bl ic co nfidence in th e ca pa ci ty of ou r food in dust ry to m ee t th e gre at chall enge 

ah ea d of it. To pr ep ar e for less th an th is will be to co nd em n a larg e p a rt of th e 

world to wide-sp read famine and po lit ic al in st ab ility on a sca le unp re ce den te d in 

hi st or y. He nc e, th er e is no re al istic alt ern ati ve ex ce pt for us to ge ar up to m ee t 

th is ch all en ge .

H .R . 7655 will ha ve th e be ne fic ial effect of sp ee ding up th e in tr oduct io n of 

ne w an im al dr ug s useful in th e ov erall ef fo rt to m ee t th is chall en ge . I commen d 

th is mea su re as a co ns truc tive a tt e m p t to ad van ce th e in te re st s of ou r farm ers 

and th e co ns um ing pu blic.

Att ac hm en t 2

P urpo se, Sum ma ry, and Ana ly sis of H .I t. 3639, P re pa re d by th e Anim al

H ea lth I nst it ute , Was hi ng to n, D.C ., F eb ru ar y 1967

HR 3639: IT S PU RP OS E

T he pr in ci pal pu rp os e of H R 3639, in tr odu ce d Ja n u ary 24, 1967, by Re p. 

Jo hn Ja rm an (I)-O kl a.), is to bett er pro te ct th e pu blic hea lth and pr om ote the 

pu bl ic welfare by co ns ol idating th e dive rse , ov er lapp ing and contr ad ic to ry section s of th e Fed er al Fo od , Dru g, an d Co sm etic Ac t re gu la ting th e pre m ar ket in g 

clea ranc e of ne w an im al dr ug s in to one se ct io n of th e Ac t sp ec ifi ca lly pla nn ed for 

su ch drug s. Thi s pu rp os e wo uld be ac hi ev ed w ithout re du ct io n in th e rig id con ­

trol s ne ce ss ar y fo r pu blic hea lth im po se d by ex istin g law . The Am en dm en ts are 

de sig ne d:

(1) To el im in at e th e du pl ic at e an d tr ip lica te co ntro ls cu rr en tly impo sed 

by se ctions 409, 505, and 507 of th e Act.

(2) To cr ea te a sin gle sta tu to ry st an d ard of sa fe ty an d eff ec tiv en ess for 

an im al dr ug s in a new se ct ion 512, th u s el ev at in g su ch drug s to a po sitio n 

eq ua l to th a t of drug s and an tibio tics fo r hu m an use an d of hum an foo d 

ad di tive s.

(3) T o es ta bl ish a re alistic sta tu to ry mec ha nism for th e pre m ar ket in g 

cle aran ce of new an im al d ru gs an d of an im al fee d be ar in g or co nt ai ni ng them ,
ANIMAL DRUG AMENDMENTS OF 19 67 41

th us elim in atin g th e ne ce ss ity fo r leg al fic tio ns by which th es e pro ducts 

are re gu la te d un de r ex isting law .

(4) To pr ov id e ap pro pri ate co ntro ls ov er an im al dru g m an ufa ct ure rs and 

ov er feed m an uf ac tu re rs us in g su ch drugs.

(5) To pre vent re cu rr in g de lays in th e in troduct io n of new an im al drug s 

and to faci lita te th ei r av ai la bi lity to th e pr od uc er s of liv es to ck an d po ultry 

follow ing discov ery and de ve lo pm en t.

D ur in g prev ious he arin gs co ndu ct ed by th e Sub co m m itte e on Pu blic H ealth 

an d Sa fety of th e C om m itte e on In te rs ta te and Fo reig n Co mmerce of th e Hou se 

of Rep re se nt ativ es , su bst anti al ev iden ce of th e ne ed for mod ifi ca tio n of th e ba sic 

Ac t wa s pr es en ted. W itn esses de sc ribe d th e unto w ar d de lays in th e proc essin g of 

ap plic atio ns , th e du pl ic at e, and so m etim es trip lica te , re qu irem en ts, and th e 

dif ficulties en co un te re d by th e Fo od an d D ru g A dm in is trat io n in th e pre m ark etin g clea ranc e proc ed ur es re qui re d by th e th re e se par at e sections of th e Act.

Rep re se nt at iv es of th e Fo od an d D ru g A dm in istrat io n an d mem be rs of th e 

Sub co m m itte e off ere d su gg es tio ns fo r mod ifi ca tio n whic h wou ld en su re ful l and 

co m pl ete pr ot ec tion to all en ga ge d in th e use of an im al dr ug s an d to th e pu blic. 

All su ch sugg es tio ns ha ve be en in co rp or at ed in H R 3639, th e An im al D ru g 

A m en dm en ts of 1967, wh ich includ es th e follow ing :

1. R eq ui re m en ts fo r th e ke ep ing of reco rd s an d th e mak in g of re port s w ith 

re sp ec t to in ve st ig at io nal dr ug s an d to dr ug s ap pr ov ed for mar ke ting .

2. Add iti on al gr ou nd s for w ith dr aw in g ap pro val of an ap pl ic at io n w ith 

re sp ec t to a new an im al dr ug .

3. A pr ov isio n wh ich wou ld pro hi bi t th e ex po rt of an un ap pro ved new 

an im al dr ug ev en th ou gh th e dru g be ap pr ov ed in th e co untr y of des tina tion .

4. The inclus ion of field tria ls w ith in th e m ea ni ng of th e re quir em en t of 

su bst anti al ev iden ce of effecti ve ne ss ap pl ic ab le t o n ew a ni m al drug s.

5. A st ri ct pr ohib itio n of, in lie u of di sc re tionar y au th o ri ty to pr ohib it, 

any t ol er an ce l im itat io n w hich exceeds t h a t re as on ab ly re quired to ac co mplish 

th e ph ys ical or oth er te ch ni ca l eff ect fo r which th e dru g is in te nd ed .

6. A pr ov ision ex clud in g fro m th e he ar in g an d ju di ci al review pr oc ed ur es 

th e det er m in at io n of m et ho ds of ex am in at io n pr es cr ib ed un der th e D el an ey 

ca nc er clause .

7. A prov ision th a t a ne w a ni m al drug , in te nded f or i nc or po ra tion in to feed, 

is un safe when sh ip pe d from th e m an ufa ctu re r un les s su ch m anufa ctu re r ha s 

an un re vo ke d w ri tt en st ate m en t fro m th e consign ee, or no tic e from th e 

Sec re ta ry , th a t th e c on sig nee of th e d ru g is th e h olde r of an ap pro ved a pplica ­

tion co ve rin g th e fee d, or th a t th e consign ee, if no t himself a m an ufa ct ure r, 

will in tu rn sh ip th e du rg on ly to a ho lder of su ch an ap pro ved ap plica tion.

D ur in g th e 88 th and 89 th Co ng ress, th e Animal H ea lth In sti tu te wor ke d di ligen tly w ith re pre se nta tives of th e Fo od and D ru g A dm in is trat io n, th e D ep art ­

m en t of H ea lth , E duca tion an d Welf are , and th e C om m itte e on In te rs ta te an d 

Fo reign Com merce to mak e th e Animal Dru g A m en dm en ts ac ce pt ab le t o G ov er nm en t, th e he al th professio ns, and in dust ry . T he Bill as revi se d by th e 89t h 

Co ng ress (H R 16474) did pa ss th e Hou se b u t died in th e Sen at e whe n he ar in gs 

we re re qu es te d a t a tim e whe n it was too la te to sc he du le th em be fore adjo urn ­

m en t. The Animal Dru g A m en dm en ts of 1967, as no w dra ft ed and in th e op inio n 

of th e Animal H ealth In sti tu te , in clud e all ne ce ss ar y pr ov isions to sa fe gu ar d th e 

pu blic hea lth an d ac co m plish th eir an no unc ed obj ec tive s. The on ly dif fer ence 

be tw ee n H R 16474 and th e curr ent Bill II R 363 9 is th a t th e am en dm en ts wo uld 

be co me effecti ve tw elve m onth s ra th e r th an six m onth s aft er en ac tm en t.

The ne ed for se para te sta tu to ry co nt ro l an d re gula to ry tr eatm en t of new 

an im al dr ug s ha s incr ea se d du ri ng and aft er th e 88t h and 89 th Co ng res s. L as t 

yea r th e ag en cy a ga in en co un te re d ex tens ive pr ob le m s in th e p roce ssing of ap pl ic atio ns . Also , in op er ab le re gu la tion s we re pr op os ed fo r ne w an im al drug s, which 

appare ntl y we re pr ed ic at ed on re gu la tion s go ve rn in g dr ug s fo r hum an use . The 

pa ss ag e of th e A ni m al Dru g A m en dm en ts of 1967 will pr ov id e th e ag en cy w ith a 

sta tu to ry fram ew or k of be ne fit to th e hea lth professio ns, fee d m an ufa ct ure rs , 

liv es to ck and poult ry pr od uc er s, co ns um ers, an im al dr ug m an ufa ct ure rs , and th e 

Fo od and D ru g A dm in is trat io n.

B R IE F SU MMAR Y O F ANIM A L D RUG A M EN D M EN TS TO TH E FED E R A L FO OD, D R U G , 

AN D COSM ET IC AC T

The se am en dm en ts co ns ol idate th e pr ov isions of th e Fed er al Fo od , D ru g an d 

C os m et ic Ac t, as a m en de d, go ve rn in g th e pre m ar ket in g cle aran ce o f a ni m al dr ug s. 

The se am en dm en ts ad d to th e ba sic st atu te a new Se ction 512, which es ta bl ishe s 

th e re qui re m en ts of sa fe ty and eff ec tiv en ess ap plic ab le to new an im al drug s,
42 ANIMAL DRUG AMENDMENTS OF 196 7

including animal feeds bearing or containing such drugs. Proposed Section 512 replaces the application to animal drugs of the three separate prem arke ting section clearance procedures contained in existing law: Section 409 (food additives) Section 505 (new drugs) and Section 507 (antibiotic drugs). Any new animal drug, or any animal feed bearing or containing such a drug, is considered adu lterated unless it meets the requirements of proposed Section 512.

Under th e new Section 512, an application is filed with respect to each intended use of a new animal drug, whether the drug is to be used in a finished pharma­ ceutical, in an animal feed, or as a component of such feed. Such application contains inform ation necessary to demonstrate the safety and effectiveness of the proposed use, including practicable methods for determining residues in or on food, as well as a full description of the manufacturing and control procedures employed with other required data. Upon approval of the application, notice of the approval is published in the Federal Register. If the drug is to be used in animal feed, applicable purposes and conditions of use of the drug in animal feed are also published. The use of any new animal drug in animal feed is governed by the published purposes and conditions of use. Consequently, an application for an animal feed containing a drug component is approvable if its labeling conforms to the published purposes and conditions of use and if current good manufacturing practices are utilized.

Procedures are set forth in proposed Section 512 for the granting or w ithdraw­ ing of approvals of new animal drugs and of animal feed bearing or containing such drugs, and for judicial review, including summary suspension of applications in the event of imminent hazard to health. This section also provides for the issuance of regulations governing investigational use of new animal drugs and the keeping of records and the making of re ports with respect to the use of new animal drugs. In addition, this section continues batc h certification of the five antibiotics for animal use currently subject to batch certification.

The remainder of the bill contains technical and conforming amendments and transitional provisions. These provisions carry out the purpose of the bill to consolidate existing provisions in the basic law. They also provide for the con­ tinuation of existing approvals granted under the present law.

A SECTIO N A N A LY SIS OF H .R . 3639, ANIM AL D RUG A M END M EN TS TO T H E FED ER A L 

FO OD, D RUG , AN D CO SM ET IC ACT

The first section of the Bill would provide th at the Act may be cited as the “Animal Drug Amendments of 1967.”

Section 101(a) of the Bill would amend section 501(a) of the Federal Food, Drug and Cosmetic Act (hereinafter referred to as the “basic Act”) to deem any new animal drug, or animal feed bearing or containing a new animal drug, to be adu lterated if it is unsafe within the meaning of section 512 as adde d to the basic Act by section 101(b) of the Bill. Thus, the provisions of chapter II I of the basic Act, e ntitled “Prohibited Acts a nd Penalties,” would apply to a new animal drug, or animal feed bearing or containing a new animal drug, in inte rstate com­ merce to the same extent as any other adu lterated article unless an approval of an application filed pursuant to new sections 512(b) or 512(m), respectively, is effective w ith respe ct to that drug or animal feed.

Section 101(b) of the Bill would add to the basic Act new section 512, entitled “New Animal Drugs.” New section 512 provides for the approval or refusal and withdrawal of approval of new animal drug applications by the Secretary and requires the sponsor of a new animal drug to dem onstrate the safety a nd effective­ ness of the proposed use or uses of that drug. Similar provisions are made for animal feeds bearing or containing new animal drugs. Section 512 is pattern ed after the new-drug section of the basic Act (section 505) as amended by the Drug Amendments of 1962, and it consolidates the preclearance provisions applicable to new animal drugs and animal feeds bearing or containing new animal drugs presently contained in the food additive section (section 409) and the antibiotic section (section 507) as well as section 505. Thus uniform administration of pre-clearance requirements is assured.

New section 512(a)(1) would deem a new animal drug to be unsafe unless an approval of an application is effective with respect to such drug. New section 512(a)(2) would make similar provision for an animal feed bearing or containing a new animal drug. Additionally under new section 512(a)(1), an approved new animal drug for use in feed may be shipped only to those who hold approved applications for the feed or who will re-ship only to holders of approved applica­ tions for the feed.
ANIMAL DRUG AMENDMENTS OF 19 67 43

New section 512(b) would replace section 505(b) of the basic Act for new 

animal drugs by specifying the inform ation to be included in a new animal drug 

application. Clauses (1) through (6) would require th e same information presently 

requ ired in section 505(b). Clauses (7) and (8) are added to replace for new 

animal drugs sections 409(b)(2)(D) and 409(c)(4) of the basic Act. The latte r 

two clauses are desirable in the event residues of the drug remain in the tissues 

of the animals used for food productio n and a tolerance or withdrawal period is 

proposed.

New section 512(c) is subs tantially identical with section 505(c) of the basic 

Act in setting forth the procedure for action by the Secretary upon a new animal 

drug application.

New section 512(d) would replace section 505(d) of the basic Act for new 

animal drugs by setting forth the grounds upon which the Secretary may refuse 

to approve a new animal drug application. Clauses (A), (B), (C), (D), (E) and 

(G) of new section 512(d)(1) are identical to clauses (1) through (6) of section 

505(d). Clause (F) of new section 512(d)(1) would replace for new animal drugs 

section 409(c)(4) of the basic Act, relating to tolerance limitations, but would 

not modify th e S ecre tary’s existing authority. Clause (H) of new section 512(d)(1) 

would replace for new animal drugs section 469 c) (3) (A) of the basic Act by 

requring the Secretary to refuse approval of an application for a new animal drug 

which induces cancer when ingested by man or animal. This clause is substantially 

identical with the proviso in section 409(c) (3) (A) as amended by the Drug Amendments of 1962.

Clauses (A), (B) and (C) of new section 512(d)(2), in specifying certain factors 

to be considered by the Secretary in determ ing whether a new animal drug is 

safe, would replace section 409(c)(5) of the basic Act. Clause (D) of new section 

512(d)(2) is intended to give the Secretary added autho rity to consider safety 

questions in those instances where the prescribed conditions of use will not be 

followed.

New section 512(d) (3) would incorporate the definition of “substan tial evidence” 

of effectiveness inserted in section 505(d) of the basic Act by the Drug Amendments of 1962.

New section 512(e) is based upon and is substantially identical to section 505(e) 

of the basic Act. As in the case of section 505(e), the new’ section 512(e) would 

give the Secretary summary powers to act if he finds th at there is an imminent 

hazard to the health of man or of th e animals for which the drug is intended.

New section 512(f) is substan tially identical to and, for new animal drugs, would 

replace section 505(f) of the basic Act, relating to the reinstatement of applications. Such provisions would also be applicable to orders concerning applications 

for animal feeds bearing or containing new animal drugs.

New’ section 512(g) is substantially identical to and, for new animal drugs, would 

replace section 505(g) of th e basic Act, relating to Service of Orders.

New section 512(h) adopts, for applications relating to new animal drugs and 

to animal feeds bearing or containing new animal drugs, the appeal procedures 

set forth in section 505(h) of th e basic Act.

New section 512(i) would require the Secretary to publish as a regulation in the 

Federal Register the conditions of use and the name of the applicant for every 

new’ animal drug application which is approved. If the drug is for use in animal 

feed, appropriate conditions for use in feeds approved shall be included in the 

regulation. This is new, inasmuch as there is no provision for such publication 

in section 505 of the basic Act. However, in view of the practice of mixing two 

or more drugs, which may be purchase d from different sources, in animal feeds, 

this provision has been included so as to enable feed manufacturers to ascertain 

those combinations of drugs which have been approved for use in animal feeds. 

This is necessary because the labeling for a pa rtic ular drug may not indicate such 

combinations.

New section 512(j) provides for the promulgation by the Secretary of regulations for exempting from section 512 new animal drugs, and animal feeds bearing 

or containing new animal drugs, intended solely for investigational use by qualified experts. This section is based upon and would replace sections 409(i) and 

505(i) insofar as these sections are pertin ent to the investigation of such drugs 

and animal feeds. Of par ticu lar importance, the last sentence authorizes the 

Secretary to set forth the conditions upon which animals (and their products) 

treated with such drugs may be marketed. The amendments made to section 

505(i) of the basic Act by the Dru g Amendments of 1962 relate to the clinical 

testing of new drugs for human use and are not pertin ent to the investigaton of 

new animal drugs. Therefore, they have not been included in new section 512(j).
44 ANIMAL DRUG AMEN DMENTS OF 196 7

New section 512(k) is based upon and would replace, for new anim al drugs, the 

last sentence of section 409(a) of the basic Act relating to adultera ted foods. The 

purpose of this section is to provide for an appropriate exemption from section 

402(a)(1) of the basic Act for approved uses for new animal drugs.

New section 512(1) is based upon and would replace, for new animal drugs, 

section 505(j) of the basic Act, rela ting to recordkeeping and reporting requirements.

New section 512(m) would provide for appropriate prem arketing approval procedures for animal feeds bearing or containing new animal drugs consistent with 

the provisions of new section 512(b) rela ting to approvals for new animal drugs. 

Only 90 days are provided in new section 512(m) for review of an app lication for an 

anim al feed. A longer period is n ot necessary since the Secretary under new section 512(c) is permitted 180 days for review of th e basic information rela ting to the 

safety and effectiveness of the drug component of such animal feed. The other 

provisions of new section 512(m) with respect to approvals, records, and reports 

are sub stan tially the same as those applicable to new animal drugs.

Consistent with the Drug Amendments of 1962, new section 512(n) would 

provide for the certification of batches of new animal drugs composed wholly or 

partly of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, 

and derivativ es thereof.

Section 102(a) and (b) of the Bill would amend section 201 (p) of the basic 

Act to remove new animal drugs from section 505 of the basic Act. Henceforth 

the regulation of new animal drugs would be covered exclusively by new section 

512.

Section 102(c) of the Bill would amend section 201 (s) of the basic Act to remove 

new animal drugs from section 409 of the basic Act. The reason for this provision 

is tha t new section 512 would provide for the exclusive regulation of new animal 

drugs.

Section 102(d) contains a conforming amendment to the definition of the term 

“safe” in section 201 (u) of the basic Act.

Section 102(e) of the Bill would add new paragraphs (w) and (x) to section 201 

of the basic Act defining the terms “new animal drug” and “animal feed.” The 

definition “new animal drug” is patterne d afte r the term “new drug” contained 

in section 201 (p) of the basic Act. Henceforth, these terms would be mutually 

exclusive.

Section 103 of the Bill would amend section 301(e) and 301 (j) of the basic Act. 

The effect of these amendments would perm it the Secretary access to certain 

records and provide for the confidentiality of certain information contained in 

new animal drug applications.

Section 104 of the Bill would amend section 402(a)(2) of the basic Act relating 

to adu lterated food to provide for appropriate exemptions for approved uses of 

new animal drugs.

Section 105 of the Bill would amend sections 502(1) and 507(a) of the basic 

Act by exempting therefrom animal drugs. The effect of these amendm ents is to 

require the certification of antibiotics listed in new section 512(n) in accordance 

with the provisions of such section.

Section 106 of the Bill would amend section 801(d) of the basic Act to prohibit 

the export of “unsafe” new animal drugs or “unsafe” animal feeds bearing or 

containing new animal drugs.

Section 107 of the Bill would make a technical correction to section 902(c) of 

the basic Act.

Section 108 of the Bill contains effective d ate and transitio nal provisions. Under 

this section, the Bill would take effect on the first day of the thi rteenth calen dar 

mon th following enac tment. This section also contains transition al provisions 

which would make it clear that any existing approval of a drug for use in animals 

will be deemed an approved application tinder section 512(b) or section 512(m) 

as is appropriate. In addition, section 108(b)(3) repeats essentially the language 

of section 107(c)(4) of the Drug Amendments of 1962.
ANIMAL DRUG AMENDMENTS OF 19 6 7 45

Mr. J arman. Are the re any que stio ns at thi s time?

You may proc eed, Mr. Ho lt.

STATEMENT OF JOHN M. HOLT

Mr. H olt. Th an k you, Mr. Ch airma n.

My nam e is John M. Ho lt. I am assis tant counsel of Eli Lilly & 

Co., and assis tant secre tar y of Ela nco Prod uc ts Co. Elanco Prod uc ts 

Co. is a division of Eli Lilly & Co. and is engaged in the pro du cti on 

an d distr ibution of v ete rin ary ph arm aceutic al and biological p roducts , 

me dic ate d feed additive s, other anima l healt h products, and agricultu ra l and indu str ial chem icals.

I am appearing before the subcom mittee in supp ort of H.R. 3639 

on beh alf of the Anima l Hea lth In stitu te. Our pur pose is to info rm 

you of the need fo r en ac tm en t of H.R. 3639, to advise you of the pre sen t st at ut or y clea rance pro ced ure s for animal dru gs, and to illustra te 

those st at ut or y pro ced ure s which would be followed if this measure 

is fav orably con side red by the Congress.

Mr. Ch air man, although thi s stat em en t appears quite long, it will 

no t req uir e a s ub stan tia l period of time because there are a numb er of 

exh ibits here which are brie fly referred to in the tex t.

If I might have yo ur permission , could we darke n the room and I 

will proceed wi th the stat em en t and illus tra te with slides.

We have all been adv ised of the acc elerating ra te of world population gro wth and have heard p red iction s th at this g row th in a few yea rs 

will far exceed the wo rld ’s food sup ply. Th is supply is con tinuously 

challenged by animal disease losses. De spite the acc om plishm ent s of 

scientific agriculture , livestock diseases, parasites, and inse cts still 

deprive our farme rs and our population of billions of do llars’ wo rth of 

food each year.

Th e U.S. Dep ar tm en t of Ag riculture est imate s total animal disease 

loss to be $2.8 billion ann ually. Although farmers in the Un ite d States 

have m any dru gs to assist them in dealing w ith ani ma l disease, we feel 

this staggering loss can be subs tantially reduce d by dru gs cu rre ntly 

un de r inv est iga tion and by new entities ye t to be produc ed by our 

lab ora tories.

Th e red uctio n of thes e losses is of su bs tan tia l importa nce to over 3 

million Ame rican livestock farmers and the 30 million American housewives who pur cha se their pro ducts.

Th e animal healt h indu str y tak es su bs tantial prid e in the pro ducts 

develop ed in the last 15 years to comb at animal disease and agricu ltural waste. Mu ch rem ain s to be done, however, and our research 

lab orato rie s a re atte m pt in g to develop new prod ucts to meet the need s 

which we have describ ed.
46 ANIMAL DRUG AMENDMENTS OF 196 7

There are, of course, many problems to be overcome during the 

period between the discovery and utilization of a new drug. H.R. 

3639 affects only one aspect of the research, development and regulatory programs that precede the marketing of a new pharmaceutical 

for animal use. The bill is most important, however, because of the 

present clearance procedures for animal drugs. Under the Federal 

Food, Drug, and Cosmetic Act, the channels for clearing animal 

drugs are in many instances far more complicated than those for 

human drugs. These procedures and their administration have added 

to the cost of urgently needed new animal drugs and prevented them 

from reaching the farming community for substantial periods of time.

The situation is due in large measure to the existing statute which 

was enacted without full consideration of its impact upon animal drug 

approvals.

From the Food and Drugs Act of 1906 through the Federal Food, 

Drug, and Cosmetic Act of 1938 with its subsequent amendments, 

human drugs have been the primary subject of concern. Althouth the 

term “ drug” has been defined in section 201(g) of the basic act to 

include “ * * * articles intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of disease in man or other 

animals,” the clearance of new animal drugs has been secondary to 

human considerations.

Although compounds for human use are cleared under one, and 

only one, of the various clearance sections of the Federal Food, Drug, 

and Cosmetic Act, animal drugs in many instances are reviewed under 

two of the applicable sections.

There are three appropriate statutory channels under which compounds may be cleared for human use. Section 409 contains the applicable procedures for the clearance of food additives. Section 507 

provides for the certification of antibiotics. New-drug applications 

are processed under section 505.

The situation with respect to animal drugs departs substantially 

from these procedures, As a given animal drug may be incorporated 

in an animal feed, it must receive dual clearance under section 409 

and section 505. In fact, a new veterinary pharmaceutical intended 

for injection in livestock m ust receive section 505, or new-drug application clearance, as well as section 409, or food additive clearance, 

if the livestock or the products of such livestock are intended as food 

for man. Dependent upon the volume of new animal drug submissions, certifiable antibiotic submissions, and food additive petitions, 

this situation can and has, on occasion, created substantial delays and 

backlogs in the administration of the present act.

An examination of applicable procedures will indicate the variations 

in animal drug clearances possible.

Exhibit I shows how an application for a new drug for human use 

moves toward approval. The new-drug application is studied under 

section 505. If approved, the drug can be cleared for market within 

180 days.
ANIMAL DRUG AMENDMENTS OF 19 67 47

E X H IB IT I

ST ATUTORY PR OC ED UR E

FOR

PR E- CL EAR ANC E OF HUMAN DRUGS

New drug

ap pl icat ion

Sub mitted

un de r

SECT ON 505

K

AGENCY

APPROVAL

MAXIMUMISOCA^ MARKET

IM MED IO

V

TOTAL

TIME

180

DAYS

EX H IB IT I I

PRESENT REGULATORY CLEARANCE PROCEDURE

F o r

New A n im al D ru g - No nf o o d - P r o d u c in g Anim a l

New D ru g

r\ FDA

A p p l i c a ti o n [ Maximum \

| 18 0 Da ys /

A p p r o v a l

S5 05 V NDA

T o t a l S ta t u te 

R ev ie w Tim e

180 Da ys

Exhibit II shows the procedure for one type of animal drug clearance, tha t is, a new animal drug for a non-food-producing animal, 

such as a dog or household per. A new animal drug application is 

filed and is considered under section 505. The agency has 180 days in 

which to act from the date it considers the application filed. Again, 

this is a relatively simple procedure from the standpoint of statutory 

control.

EX HI BIT I I I

PRESENT REGULATORY CLEARANCE PROCEDURE

F o r

New Ani m a l D ru g __F o o d -P r o d u c i n g A nim a1

FUA A p p ro v e d 

NBA F o r New D ru g 

And I s s u e d R e g u la tio n 

F o r F ood A d d i t i v e

T o t a l S t a t u t o r y 

__ R e v ie w T im e__

2 1 0 D ay s

Exhibit III, however, demonstrates the clearance route followed by 

a new animal drug for a food-producing animal. The new-drug application is submitted under section 505 of the act, and the Food and 

Drug Administration has 180 days in which to act upon the application. Usually at the time of initial submission of the NDA, a food
48 ANIMAL DRUG AMENDMENTS OF 19 67

additive petition is submitted to the Food and Drug Administration 

under section 409 of the act. Under this provision of the act, the 

agency has a maximum of 210 days in which to act. The total time 

contemplated under the statute is 210 days.

EXHIBIT IV

PRESENT REGULATORY CLEARANCE PROCEDURE

F or

C e r t i f i a b l e A nim al A n t i b i o t i c - N o n fo o d -P ro d u c in g A niw nl

A n t i b i o t i c FDA I n d i v i d u a l B a tc h

Fo rm #5 No T im e \ Is s u e d + C e r t i f i c a t i o n on

Li in i t a t io n / A n t i b i o t i c

850 7 R e g u la tio n C e r t a in A n L ib io tic s

T o t a l S t a t u t o r y 

__ Rev ie w Tim e _

No S t a t u t o r y 

Ti m e

Exhibit IV illustrates the procedures for a certifiable antibiotic for 

a pet or non-food-producing animal subject to section 507 of the 

statute. No specific time limit is provided for approval. Following the 

initial approval, each hatch of the antibiotic will require individual 

certification.

Exhibit V illustrates the procedures applicable to a certifiable 

animal antibiotic for a food-producing animal. This requires clearance

EXHIBIT V

PRESENT REGULATORY CLEARANCE PROCEDURE

F o r

C e r t i f i a b l e Ani m al A n t i b i o t i c - F o o d -P '- cd u c i n £ Ani m al

T o t a l S t a t u t o r y 

R evie w Tim e

under section 507 of the act as well as section 409. There is no statutory 

time limit under section 507. However, as mentioned earlier, there 

is a 210-day time limit under the food additive section 409. In addition, 

this antibiotic may require individual batch certification.
ANIMAL DRUG AMEN DMENTS OF 19 67 49

Ex hibit VI demo nstra tes th at th e pre sen t st at ute is pa rti cu larly 

com plic ated for new drug s inten ded for animal feeds for f ood-p roducing 

anim als. B oth section 505, governin g n ew-drug procedu res, and section

EXHIBIT VI

PR ES EN T REGULATORY CLE ARANCE PROCEDURE

For

New A n im a l Druf> F o r F e e d , F o o d - P r o d u c i n g A n 5in a 1

Total Statutory

409, concern ing food additive s, are involved in the prim ary clearance 

of the com pou nd. Th e agency has 180 days to act under section 505 

and 210 days under section 409.

The se periods of tim e run concurr ently with respec t to th e orig inal 

app lication and petition of the drug manufacturer . How ever, after 

th e safe ty a nd efficiency of th e new compound ha ve been de mon str ated, 

the new -drug applicat ion appro ved , and a food ad dit ive reg ula tio n 

issued, each feed man ufacturer must ob tai n a sec ondar y clea rance for 

each of his plants either throu gh the submission of a new -drug appli catio n or a form 1800. Th e law pro vides th e age ncy an ad ditio na l 180 

day s for this.

Co nsequently, the stat ut or y tim e req uir ed for clearanc e totals 390 

days. A period in excess of a year may pass between the tim e the 

ma nu factu rer has com pleted his research and dev elo pm ent work and 

subm itted a com plete new -drug appli catio n and food ad dit ive pe tition to the Food and Dr ug A dm inistratio n th at is betwe en subm issio n 

tim e and th e pe riod whe n t he pr od uc t is ava ilab le in a me dic ated feed.
50 ANIMAL DRUG AMENDMENTS OF 1967

E X H IB IT V I I

PR ES EN T REGULATORY CLE ARANCE PROCEDURE

F o r

C e r t i f i n b l c A n t i b i o t i c F o r A n im a l Feed - F o o d -P ro d u c ln ;1

, A n im a l

T o t a l S t a t u t o r y 

R e vie w T in a

Exhibit VII demonstrates the procedures applicable to antibiotics 

for use in animal feeds for food-producing animals. These are processed under section 507, applicable to the certification of antibiotics, 

and section 409 for food additives. Section 507 imposes no time limits 

upon the Food and Drug Administration. Under section 409 the 

210-day period is permitted. Following the initial clearances obtained 

by the basic drug manufacturer, a certifiable antibiotic, form 10, or 

form 1800 must be submitted by each feed manufacturer to secure 

approval of his finished feed.

E X H I B I T V I I I

REGULATORY CLEARANCE PROCEDURES

NOW APP LICABL E TO CERTAIN ANIMAL DRU6S

NEW NON f OOP , NEW

ANIMAL FTOPUEING 4 j DRUG

DRUG ANiNAi 1R AFFLICATiON

CONSIDER­ £TXTUToCV APPLI­ ATION <7LfARANd£

APPROVED

TIME CATION

GEe 50 5 NPA 180 PAYS

CONSIDER CLEAR- CTAWB»R' CUMULATIVE

ATlOH ANCC TIM E STaTURCY TIME

NOME 180 DAYS

PRODUCING .

ANIMAL *< PETITION

------ -----------

n

SEC 5 0 5 AmrOVFP 8 0 PAYS I NPA I

SEC 4 0 9 ISSUER MEG AO PAYS NONE 2I0PAYG

_ _ _ _

CERTIFIABLE NON MOO ANTIBIOTIC

ANIMAL PROPUCiNG AH FORM 5 SEC 50 7 ISSUER KEG NONE

ANTIBIOTIC ANIMAL MAY REQUIRE INRIVIPUAL BATCH CERTIFICATION NONE

CERTIFIABLE POOP

ANIMAL PRD WeiNGj

ANTIBIOTIC ANIMAL SEC 5 0 7

SEC 4 0 9

ISGUEPREG NONE

USURP REG aOPAYS F *~*

«AY REQUIRE INPIYIPUAL BATCH CERTIFICATION zio pa ys

NEW DRUG

ANIMAL

FIEP

FOCP

producing,

ANIMAL

J AFTUCXTiOM se c 50 S ISO PAYS J

PETITION SEC 4 0 9 ISSUED REG 210PAYS » - ----------

NEW AFTrOVED

DRUG SEE 606 NPA 100 PAYS 390 DAYS

Afn icATm i

C E O Fl ABLE FOOD

ANTIBIOTIC* m X X je .M t‘

ANIMAL FEED ANIMAL '

I Antibiotic I F « p ANTIBIOTIC apfkoyfd 1 FORM 5 210 PAYS SEC SO7 NONE MFGE FORM 10 SEC 50/ FORM 10 NONE PUS fW?MI0

1 BET1T1ON SEC 4 0 9 ZIO PMST’ ----------- TiMT

FCPCRAL FOOD, DRIA6 AND COSMETIC ACT SEC 5 0s - - - SEC 5 07 ■
ANIMAL DRUG AMENDMENTS OF 196 7 51

Exhibit VIII brings these procedures together in one chart, which 

we think dramatically illustrates the confusing and inconsistent statutory procedures applicable to the clearance of animal drugs. These 

procedures have on many occasions caused extreme delays in the 

approval of new animal drugs that could save farmers and housewives 

millions of dollars each year.

As shown in exhibit IX, the proposed animal drug amendments 

would establish a single procedure for handling animal drugs under a 

new section of the act. Food additives, noncertifiable antibiotics, and 

new drugs all would be processed under this section. The manufacturer 

would submit an application giving complete information about safety, 

effectiveness, components, controls, facilities, and labeling. It would 

also supply a practical analytical assay method.

PROPOSED AAf/MAL VRUG CLEARANCE

(StfDE R H.R. 3 6 3 ?

NEW DRUG K

APPLICATION M AXIM UM \ AGENCY

SU BM ITT EPUNPER 

SECTION 512

180 PAYS / APPROVAL

I

l

I

FEED

MANUFACTURERS 

N E W D RU G 

AP PLICAT ION

MA XIMU M 

9 0 DAYS

AGENCY

APPROVAL

TdTAL

TiME270

cays

The agency would have 180 days to approve the new drug, to deny 

the application, or to request additional information. If the product 

is not to be used in animal feeds, it could be marketed in 180 days.

Approval would include the publication of regulations specifying 

purposes and conditions of use, tolerances, withdrawal periods, and 

similar safety rules. If it is to be used in animal feeds, mills would 

apply for approval prior to marketing. Since safety and effectiveness 

of the drug have been established, just 90 days is allowed to process 

the mill’s application. The new feed additive could be on the market 

in 9 months instead of 14 months.

The proposed legislation retains all of the standards of safety and 

effectiveness necessary for the protection of the public health. It does 

not in any manner shortcut the procedures now in the law.

All applications must include—

(1) Reports of investigations demonstrating safety and effectiveness ;

(2) Lists of the articles used as components;

(3) A statem ent of the composition of the drug;

(4) Descriptions of the methods and facilities used for manufacturing, processing, and packaging; and

(5) A sample of the drug.
52 ANIMAL DRUG AMENDMENTS OF 196 7

Further, a sample label is required for each new drug or feed additive. The label must give the veterinarian or farmer all the information he needs for safe, effective use of the drug.

Under the bill it is necessary to describe practical methods for determining the quan tity of the drug in food and any substance formed in 

or on food due to the drug. Another requirement is tha t proposed 

tolerances or withdrawal periods be cited if they are required. For 

example, if safety requires tha t cattle be taken off a feed additive for 

a certain number of days before going to market, this timespan must 

be specified.

Each application will, of course, be subject to very careful review 

under the direction of the Secretary of Health, Education, and Welfare. These points will be studied:

(1) Tests must prove that the drug is safe for use under the conditions prescribed.

(2) Manufacturing and processing must preserve the identity, 

strength, quality, and purity of the drug.

(3) There must be substantial evidence tha t the drug is effective.

(4) Tolerances must not exceed those reasonably required to accomplish the intended effects.

(5) Labeling must not be false or misleading in any particular.

(6) Current safeguards to avoid cancer must be observed.

You will recognize tha t all existing criteria for evaluation have 

been carried over into the proposed new animal drug clearance section.

Under the proposed new section, the time permitted for approval 

of a feed manufacturer’s new-drug application for use of a new drug 

in feed is cut to 90 days. As stated earlier, the reason for this is th at 

the application is simply for the use in feed of a new drug that already 

has been approved. Since the safety and effectiveness have been 

previously established in the drug manufacturer’s new-drug application, all tha t remains to be approved are the feed manufacturer’s 

ingredients, controls, facilities, and label. This 90-day period on a 

feed manufacturer’s new-drug application is a very generous period 

of time and could well be shortened.

The enactment of H.R. 3639 will facilitate the development of 

animal drugs and eliminate the delays caused by multiple clearances. 

Regulations can be developed specifically for animal drugs; approval will no longer be based on rules developed for human drugs. 

The animal health professions and the industry will avoid the problems of contradictory policies on animal drugs. And most important 

of all, the Congress will have established how premarketing clearance for new animal drugs must be handled.

Better designed approval procedures will free more scientists for 

basic research and permit industry to explore many promising new 

fields. There are only limited product development dollars available; they may be better utilized in research rather than in conformance to duplicative and confusing administrative procedures.

In summary, gentlemen, the Animal Health Institute endorses 

the objectives of H.R. 3639 and recommends its enactment. This 

measure will bring to the American people the benefits which may 

be obtained through this substantial improvement in new animal 

drug clearance procedures.

Mr. Jarman. Dr. Roehm, Mr. Holt, tha t was an excellent presentation.
ANIMAL DRUG AMEN DMENTS OF 19 67 53

Mr. Rogers?

Mr. Rogers. I would join with the chairman in saying the committee does appreciate this presentation. I think the action by the 

House previously should indicate what action will be taken on this 

bill. We would hope tha t the Senate would find time to act on this 

legislation as well.

Thank you very much. Thank you, gentlemen.

Mr. J arman. Mr. Nelsen?

Mr. Nelsen. No questions, except to thank you for a very fine 

presentation and testimony.

Mr. Jarman. Dr. Carter?

Mr. Carter. No questions.

Mr. Jarman. Mr. Skubitz?

Mr. Skubitz. No questions.

Mr. J arman. We appreciate your being with us and helping us make 

the record on this very important bill.

Dr. Roehm. Thank you very much, Mr. Chairman.

Mr. J arman. The next witness is Mr. Warren Armstrong, repre senting the American Feed Manufacturers Association. We understand 

Mr. Armstrong is accompanied by Mr. Lee Boyd, director of nutrition, American Feed Manufacturers Association; and Mr. Joseph 

Parker, the counsel for the association.

STATEMENT OF WARREN ARMSTRONG, AMERICAN FEED MANU ­

FACTURERS ASSOCIA TION; ACCOMPANIED BY LEE H. BOYD,

DIRECTOR OF FEED CONTROL AND NUT RITION

Mr. Armstrong. Mr. Chairman, members of the committee, Mr. 

Park er is not with us this morning, but Mr. Boyd is. With your 

permission I would like to read a brief statem ent we have prepared.

1 am Warren Armstrong, quality control manager for Nutrena 

Mills, the feed division of Cargill, Inc., Minneapolis, Minn. An importan t part of my responsibility with Cargill is to assure compliance by 

my company with the Federal Food, Drug, and Cosmetic Act, particularly as it relates to livestock and poultry feed.

Today I am here on behalf of the American Feed Manufacturers 

Association of which Cargill is an active member. 1 am currently 

serving as chairman of the association’s feed control relations committee, which has an active part in the formation of the association’s 

policies as they relate to State feed control services and the Federal 

Food and Drug Administration.

As I indicated, I am accompanied this morning by Mr. Lee Boyd, 

who is director of feed control and nutrition of the association. We 

would like to express appreciation for the opportunity to present our 

views concerning the proposed legislation. We believe that the bills 

which you are considering today are essential to give appropriate 

recognition to animal drugs and their use in feeds.

Members of the American Feed Manufacturers Association produce 

more than 70 percent of the feed which is sold by primary feed m anufacturers for the production of meat, milk, and eggs. Membership 

represents all areas of the United States. The annual dollar volume of 

the industry is approximately $4 billion. Feed is the largest input in 

the production of animal products—about two-thirds of the cost of 

producing meat, milk, and eggs.
54 ANIMAL DRUG AMEN DMENTS OF 19 6 7

The feed industry’s interest in animal drugs and feed additives 

eenters on the contributions they make to wholesome and economical 

animal products. These additives are generally incorporated into feed 

to lower the cost of producing livestock and poultry products through 

improved feed efficiency and the prevention of disease. It is generally 

agreed tha t modern methods of poultry and livestock production, 

and the accompanying lower costs of animal products, could not have 

been realized without the development and use of feed additives.

As feed manufacturers, we are not involved in the development 

and manufacture of animal drugs. It is the responsibility of the drug 

manufacturer to obtain basic clearance from the Food and Drug 

Administration. Feed manufacturers use only additives which have 

been approved by the FDA as being safe and effective when used under 

specified conditions. Thus, feed becomes a vehicle by which the producer of meat, milk, and eggs can conveniently avail himself of these 

important production tools.

Feed manufacturers who use animal drugs in feed must register 

each of their mills with FDA annually and are subject to periodic 

mill inspection. Medicated feeds are continually sampled and analyzed 

by FDA, as well as by State feed control officials, to provide assurance 

tha t the correct amounts of the feed additives are being used. In May 

of 1965 FDA developed a set of current good manufacturing practices 

regulations which govern the manufacture of medicated feeds.

In addition to these safeguards, before a feed manufacturer may 

use an approved drug additive in feeds, he is required to submit a detailed application to obtain further approval for each medicated f eed - 

using a new animal drug—produced in each plant. Once obtained, this 

clearance must be kept current to reflect changes in equipment, procedures, formulation and labeling. For the most part, these clearances 

are highly repetitious.

A company such as mine must obtain and continuously amend 

several hundred individual approvals for normal operations. The 

consumption of time, both by feed company personnel and the FDA 

staff, is tremendous.

For example, if several thousand feed mills want to use a newly 

developed drug after it has been approved by FDA and appropriate 

regulations issued, FDA is then faced with the job of processing 

thousands of applications. The system obviously is time consuming 

and costly to the taxpayer as well as to the feed firms. By its nature, it 

holds the threat of delays. Processing of feed company clearance applications has often been a slow, uncertain procedure as we testified 

at the hearings in 1963 and again last year.

In the past, animal drugs have been subject to sometimes excessive 

control because these controls were inherited from legislation intended 

specifically for human drugs. The American Feed Manufacturers Association, on behalf of its members, supports the proposed legislation 

which you are considering. We believe it will give FDA auth ority and 

direction to implement practical regulations tha t embody safety and 

yet permit the maximum exercise of scientific judgment.

The proposed legislation does not change the present requirements 

for medicated feed clearances which we consider to be unnecessary 

and costly. However, the bill is a significant step in the right direction 

and we thus encourage its passage.
ANIMAL DRUG AMENDMENTS OF 19 67 55

We feel it necessary to request two amendments. The first involves 

the shortening of the 90-day processing limit for medicated feed 

applications. It would appear tha t 30 days would be adequate time 

for FDA to make a decision on this type of application. In considering 

this proposal, please keep in mind tha t the FDA has already given 

basic approval to the use of these additives.

It is our hope that clearance requirements for feed manufacturers 

may eventually be greatly simplified—by administrative action or 

legislation if tha t is necessary—so tha t feed manufacturers who are 

registered and inspected by FDA can use new animal drugs as soon as 

basic approval is granted to the drug company. In the past 30 days 

we have made a proposal to the Bureau of Veterinary Medic ne in the 

Food and Drug Administration which would streamline the handling 

of animal feed applications.

If I may depa rt from the statement, I want to point out tha t we 

were given a very receptive hearing by Dr. Van Houweling and his 

staff, Dr. Kingma and Mr. Gesling. The relationship tha t the industry 

has with these gentlemen, I think, is a good one.

Secondly, we strongly urge modification of the section of the bill 

which refers to export. This section would modify section 801 of the 

act to prohibit export of products not in conformance with the provisions of the act. There seems to be no reason to deny export if the 

product is in accord with the purchaser’s specifications, meets with 

the destination country’s laws, and is labeled for export.

Other nations certainly have the right to set their own standards. 

We should not be prohibited from supplying the needs of other countries, especially with the Nation’s serious balance of payments problem. Other exporting countries of the world will be more than happy 

to supply the needs of feed-importing countries, if U.S. m anufacturers are not permitted to do so. When the standards of the recipient 

country have been met, we feel that U.S. manufacturers should have 

the opportunity to compete with other countries of the world for 

the export market. We would therefore propose the following language be added to 

the export section:

. . . unless the use or inte nded use of the new animal drug or animal feed 

complies with the laws of the country in which the new anim al drug or animal 

feed is to be used.

In conclusion, I would like to emphasize tha t there is fundamental 

agreement in the objectives of FDA and feed manufacturers. Every 

feed manufacturer must have concern for the safety and efficacy of 

his feed product—surpassing tha t of FDA. A feed manu facturer’s 

very existence depends upon the safety and quality of his product.

On behalf of the American Feed Manufacturers Association, may 

we express our appreciation for the privilege of appearing before the 

committee. We certainly would be happy to try and answer any questions the 

committee might have.

Thank you.

Mr. J arman. Thank you, Mr. Armstrong.

Mr. Rogers?

Mr. Rogers. Than k you very much, Mr. Armstrong, for your 

statement.
56 ANIMAL DRUG AMENDMENTS OF 196 7

How many feed mills are there, would you say, in the country?

Mr. A rmstrong. I don’t have an accurate figure, but I understand 

tha t there are something in the order of 12,000 registered with tiie 

FDA. Dr. Kingma could probably give you a more accurate figure 

on that.

Mr. Rogers. How many in your association?

Mr. Boyd. We have approximately 300 active members, Mr. 

Rogers. Many of these are firms such as Mr. Armstrong’s, which have 

a large dealer organization which probably makes up the bulk of this 

12,000 number tha t are registered with FDA, so we have a large 

representation.

Mr. R ogers. What is the production of your members?

Mr. Boyd. Approximately 70 percent of the feeds that are sold.

Mr. Rogers. It was my understanding that the reason they wanted 

to give an approval is, in case, for instance, if you mix two drugs 

together where they may not have tested this, and there may be a 

reaction. What is your comment on that?

Mr. Armstrong. We are not proposing tha t we would have the 

initiative to mix two drugs together tha t would not be an approved 

combination. Our interest is in more rapid clearance, more rapid 

approval of approved combinations rather than the delays tha t have 

been involved to date.

Mr. Rogers. As I understand it, when the new drug comes out, 

this approval is given. Do they give approvals for mixtures? Is this 

under a new-drug application?

Mr. Armstrong. That is correct. When an approval is given for 

an animal drug, it is given to the basic manufacturer of the drug.

Mr. Rogers. Right.

Mr. Armstrong. And we as feed manufacturers are required to seek 

supplemental applications, new-drug applications, which follow some 

of the same channels but in not quite the detail as are required of the 

basic drug manufacturers.

We do have to submit, for example, da ta as to labeling, the formulation, the control procedures, description of facilities, et cetera.

Mr. R ogers. As I understood it, when the basic manufacturer comes 

in with his new drug, he doesn’t go into all of the combinations of 

mixtures of th at drug, does he?

Mr. Armstrong. Yes. For any combination tha t would be used, he 

would seek an approval from FDA.

Mr. Rogers. In other words, you then would say tha t only those 

combinations tha t had actually been approved to the basic manufacturer would be allowed to the feed manufacturer?

Mr. Armstrong. That is correct.

Mr. Boyd. Normally this is a process of time, Mr. Rogers, in the 

fact they obtain the clearance on the basic product; when that is 

obtained they go into the clearances of combinations tha t seem 

advisable.

Mr. Rogers. Won’t tha t shorten it? Won’t they still have to get the 

approval of a mixture?

Mr. Boyd. The approval of a mixture would still be subject to 

much the same situation as an individual new drug.

Mr. Rogers. Actually the procedure is even less for you, considering the time element, than it would be for the basic manufacturer if 

you mix the drug?
ANIMAL DRUG AMENDMENTS OF 196 7 57

Mr. Armstrong. Yes; but we should point out tha t the product 

we are selling is a diluted one, much diluted from what the original 

manufacturer is seeking to market.

Mr. Rogers. But if the mixture had the approval of Food and 

Drug, then you see no reason why 30 days shouldn’t be sufficient to 

approve it?

Mr. Armstrong. That is correct.

Mr. Boyd. The basic efficacy, safety and such have all been established. All we have then is approval-----

Mr. Rogers. You could use it only within the limits of the amount 

of mixture approved?

Mr. Armstrong. Tha t is correct.

Mr. Boyd. And these are spelled out in the regulations issued in 

the Federal Register, carried in the trade press and also included in a 

publication called the Feed Additive Compendium, which enables the 

feed industry to know what levels are approved for what combinations.

Mr. R ogers. With my experience with the Department, it is quite 

difficult to get a letter answered in 30 days.

Mr. Armstrong. One of the reasons we have suggested 30 days is 

tha t we have indicated procedurally tha t a letter should not be 

necessary, and the form has been designed tha t would eliminate the 

need for a letter if all is in good form.

Mr. Boyd. We have good relations with FDA, we have designed a 

form which they endorse a copy and send it back to us. It does away 

with typing a letter and such.

Mr. Rogers. Of course, your own control procedures are gone into 

in this application.

Mr. Armstrong. They are all spelled out in the application.

Mr. Rogers. And your mixture?

Mr. Armstrong. Yes, time and all is included.

Mr. R ogers. I think your suggestion about the exporting has a 

great deal of merit. What is the argument against doing that?

Mr. Armstrong. I ’m not prepared, Mr. Rogers, really to argue 

tha t side of the point. It seemed to me tha t perhaps the basic provisions of the act described in 801 would probably have been sufficient, 

but apparently there is a loophole, and the loophole apparently has 

been bottled up to such an extent tha t it would involve us seriously, 

and I don’t think tha t it was really the intent to block animal feed.

Mr. Rogers. Thank you.

Thank you very much, Mr. Chairman.

Mr. J arman. In tha t connection, if we amended section 106 as 

you suggest, the animal drugs for export section, don’t you think 

that this country might well be open to a charge of dumping of products abroad tha t did not meet the standards tha t we recognize here 

at home?

Mr. Armstrong. No. Our interest in amending this section is to 

give us an o pportunity to sell in export channels certain concentrates 

we would understand the proposed section 106 of the bill would prohibit. Concentrates are products commonly sold by the feed industry 

tha t contain higher than complete feed levels of protein, vitamins, 

minerals, drugs, and so forth, and are intended to be mixed with grains 

or other non-drug items to make a complete feed. In different concentrates the use ratios may vary from less than 1 part of grain to 1 

part of concentrate to 10 or more parts of grain to 1 part of concen-
58 ANIMAL DRUG AMENDMENTS OF 19 67

trate. For reasons not perfectly clear to ns, the FDA has established 

maximum use levels of some drugs in concentrates for dilutions tha t 

either prohibit their use in concentrates or are too low to be realistic. 

This kind of product always carries the appropriate drug level and mixing instructions that provide for currently FDA approved drug levels 

in the finished product. It seems to us there is no good reason to prohibit the export of these products providing they meet the requirements of the country to which they are being shipped, the requirements of the customer, and they are marked for export. The purpose 

of this proposal is not to permit us to export drugs in animal feeds tha t 

have not met the safety and efficacy standards of the FDA for use in 

complete animal feeds.

Mr. Jarman. But if we change the language as you suggest, would 

it not make possible the shipment of many products that do not meet 

American standards to areas of the world tha t have few, if any, 

standards?

Mr. Armstrong. I can only answer your question this way, Mr. 

Chairman. It’s my understanding in checking this out with our 

counsel tha t this would not be so, and I would only continue on his 

advice in that regard.

Mr. J arman. Let me ask this: This is opinion, of course, but the 

present hill is a consolidation of present law?

Mr. Armstrong. Right.

Mr. J arman. If we change this section as you recommend, would 

it not inject subject matter that could make for controversy in the 

consideration of this bill in the Congress?

Mr. Boyd. Mr. Jarman, I don’t believe so, from the standpoint if 

you look at our proposed language, in essence, is what we are returning 

to what we now have in the Food, Drug, and Cosmetic Act for animal 

feeds. Commissioner Goddard stated there was nothing new being 

added by this proposal.

I myself would have to ask the question: If nothing new is being 

added, why amend tha t section? It’s being amended in our opinion 

in such a way to discriminate against animal drugs and medicated 

feeds. The current section of the law provides for an exemption for 

export and all we are doing is asking tha t tha t exemption on animal 

drugs and medicated feeds be reestablished or spelled out.

Mr. J arman. Of course, Dr. Goddard’s testimony this morning in 

response to a question was the very definite position tha t it makes no 

change in existing law.

Mr. Boyd. I would have to respectfully disagree with that. I 

think we can read the section right now, Mr. Chairman, and you will 

see that it does add something. Otherwise, I question why would they 

include it?

Mr. Jarman. I can assure you tha t the subcommittee will study 

this with care.

Mr. Skubitz. You suggest the proposal to change the limit from 

90 days to 30 days. Could the FDA do this?

Mr. Armstrong. This came as part of the discussion I had with 

Dr. Van Houweling and his staff within the past 30 days, and I did 

indicate tha t we thought 30 days was a reasonable figure and, in fact, 

not completely in jest indicated tha t I thought even 5 days was a 

reasonable objective.
ANIMAL DRUG AMEN DMENTS OF 19 6 7 59

Mr. Skubitz. What was the attitude of FDA?

Mr. Armstrong. He did not respond.

Mr. Jarman. Are there any further questions?

Mr. Rogers. No further questions.

Mr. Jarman. Gentlemen, we appreciate your being with us to help 

make the record.

Mr. Armstrong. Thank you.

Mr. Jarman. Our next witness is Dr. Frank Todd, Washington 

representative for the American Veterinary Medical Association, 

who will be representing, and presenting a statement for, Dr. Robert 

J. Schroeder, president of the association.

Dr. Todd?

STATEMENT OF DR. FRANK A. TODD, WASHINGTON REPRESENTATIVE, AMERICAN VETERINARY MEDICAL ASSOCIATION, ON

BEHALF OF DR. ROBERT J. SCHROEDER, PRESIDENT, AVMA

Dr. Todd. Mr. Chairman, members of the committee, I am Dr. 

Frank A. Todd, Washington representative of the American Veterinary Medical Association. Dr. Robert J. Schroeder, president of 

the American Veterinary Medical Association, has prepared and 

submitted a statement on behalf of the association, pertaining to 

H.R. 3639.

Dr. Schroeder has asked tha t I present it to this committee. It is 

short and I would like to read it for the record of this hearing.

Mr. Chairman and members of the committee, the American 

Veterinary Medical Association appreciates this opportunity to 

present a statement on H.R. 3639, a bill to protect the public health 

by amending the Food, Drug, and Cosmetic Act, to consolidate certain 

provisions assuring the safety and effectiveness of new animal drugs.

Our understanding of the bill is tha t it would bring together in a 

new section of the Federal Food, Drug, and Cosmetic Act, most of 

the requirements for the approval of new drugs for animals. The 

provisions of the act applicable to animal drugs are now scattered 

among three different sections—409, 505, and 507—with much lack 

of uniformity in the use of terms and in the procedural requirements 

of the several sections.

Drugs for animal use must be reviewed for safety and efficacy with 

respect to each particular species of animal for which i t is to be used 

and also, from the standpoint of the residues which may carry over in 

meat, milk, or eggs derived from food-producing animals.

Many animal drugs also are, technically, food additives in that they 

are added to the food or drink of animals. These complications necessarily add to the problems of determining compliance with the act.

Under the terms of H.R. 3639, the process of review of a drug for 

animal use in the Bureau of Veterinary Medicine of the Food and 

Drug Administration would include considerations of food additive 

requirements and of residues in meat, milk, or eggs, as an integral 

part of the review process under unified language of the statute, which 

would tend to remove uncertainties as to the substantive and procedural requirements in each case.

This would be a benefit to the applicant for drug approval, as he 

would be able to find all of the requirements which his product must 

meet in one section of the act clearly identified for animal drugs.
60 ANIMAL DRUG AMENDMENTS OF 19 67

In lik e ma nner, it would be useful to the ad mi nis tra tio n by simplifyin g 

the processes of review and red uci ng the possibilities of error.

Mr. Ch airma n, this legislation is the result of several yea rs of work 

on the pa rt of both the indu stry and the Food and Dr ug Ad ministration. Th e several hearings held by this com mittee have serv ed to 

ide ntify differeing points of view and to enco urage the resolution of 

thes e differences. As a result of thes e efforts, the language of the 

proposed legislation has been imp roved, both to simplify the pro ­

cedu res and to make sure th at all nece ssary au thor ity requir ed by the 

Food and Dr ug Ad mi nis tra tio n to assure the safe, efficacy, and 

proper labeling of animal dru gs would be prov ided.

Mr. Chairma n, I am autho rized by my asso ciation to supp ort 

the bill, H.R . 3639, and to recommend its passage. Tha nk you for 

the op po rtu nity to pre sen t the views of the American Ve ter inary 

Medica l Association.

Mr. J arman. Dr. Todd, it ’s good to hav e this statem en t as a pa rt 

of our reco rd, particular ly in view of the fac t th at yo ur asso ciation 

some years ago did oppose some of the language of H.R . 7247, the 

original bill on this sub ject. I t is encoura ging th at the hearing s and 

the mee tings betw een indu str y and FD A have reso lved differences 

and th at we hav e a bill th at mee ts rpost, if no t all, of the objections 

in this field.

Mr. Rogers?

Mr. R ogers. No questio ns.

Tha nk you, doctor.

Mr. J arman. Mr. Sku bitz?

Mr. Skub itz. No questio ns, Mr. Chairma n.

Mr. J arman. Th an k you very much.

Our final witness this mornin g is Mr. Fr an k Frazier of the Na tio nal 

Bro iler Council.

STATEMENT OF FRANK FRAZIER, EXECUTIVE VICE PRESIDENT, 

NATIONAL BROILER COUNCIL

Mr. F raz ier. Mr. Ch airma n, mem bers of the sub com mittee , my 

name is Fr an k Fra zier. I am executive vice pre sid ent of the Na tio nal 

Broiler Council. I am autho rized by the Bo ard of Direc tor s of NB C 

to ap pe ar here in sup po rt of H .R . 3639, the An imal D rug A mendments 

of 1967.

rFlie National B roiler Council, head qu art ered in the Madison Bu ild ­

ing, Wa shington, D.C ., rep res ents those who in 1966 produced and 

marke ted over 65 percent of the Nat io n’s 2.5 billion broilers.

Mr. Chairma n, the commercial broiler indu str y has shown a dr amatic and spect acu lar gro wth in its develop me nt since the early 

1940’s. Du ring this period it was deve loped from an indu str y chara cterized bv small un its of pro duction, rep res enting one of ma ny en ter ­

prises on fam ily-type farm s, to a highly specialized and comm ercialized 

integ rated ind ustry . Adoption of techn olog ical adv anc es in pro duction 

and processing has lowered cos t and co ntr ibute d greatly to its rapid 

dev elopm ent and expansion.

The benefits of increased productio n efficiency hav e been passed on 

to consumers in the form of lower prices. The retai l p rice p er pound of 

dressed eviscerate d whole broilers, for exam ple, is often less to da y 

than the Georgia far m price for live broilers in 1947.
ANIMAL DRUG AMENDMENTS OF 19 6 7 61

Two of the important factors contributing to this progress are 

increased research and the availability of drugs and vaccines for use in 

broiler production.

Two years ago, Dr. E. O. Essary of the Virginia Polytechnic Institute said, “Progress in broiler production has been the result of 

important research contributions made by geneticists and nutritionists in developing strains of broilers which grow faster on less feed. 

Mortality has been greatly reduced by improved management and 

disease prevention programs.” Passage of H.R. 3639, we hope, will 

encourage more of this research activity.

The importance of availability of new and improved poultry health 

products has increased sharply in the last few years, due largely to the 

narrowing margin between the cost of doing business and the profit 

from sales of broilers. If the broiler industry is to continue to meet the 

demands of our increasing consumer population for more broilers at 

the same low cost, it must be able to count on getting medicated feeds 

and drugs without delay.

Because H.R . 3639 is designed to speed up the introduction of new 

animal drugs, without reducing any current safety and efficacy standards, we favor its passage. And if H .R. 3639 will help the Food and 

Drug Administration streamline its administrative procedures, we 

feel sure this will stimulate more research by drug manufacturers and 

broiler producers—which in turn will result in more benefits to the 

consumer and to the economy.

For these reasons, we urge your favorable consideration of H.R. 

3639.

Thank you, Mr. Chairman.

Mr. Jarman. Thank you, Mr. Frazier. We are all appreciative of 

the progress tha t has been made in broiler production to the point 

where chicken is no longer a Sunday delicacy, but prices have been 

reduced to th e point where it is on the daily bill of fare.

We appreciate your support of the bill and your being with us here 

this morning.

Mr. Rogers?

Mr. Rogers. No questions, Mr. Chairman.

Mr. Jarman. Mr. Skubitz?

Mr. Skubitz. Mr. Chairman, I am just a new member on the committee. Is there anyone opposing this legislation?

Mr. Jarman. We have a few suggested amendments, but certainly 

there is general support.

We appreciate everyone being here, those who testified and those 

who have attended, in helping to make what we think is a very strong 

record in support of this bill.

The committee w ill stand adjourned.

(The following material was submitted for the record:)

Sta te m en t oe William R. St eph en s, P resi d ent, D elma rv a P ou ltry

I nd us tr y, I nc.

M r. C ha irm an a nd m em be rs of t h e s ub co m m itte e: As pre si de nt of th e D el m ar va 

P oultry In d u str y as so ciatio n, I wou ld lik e to su bm it th e follo wing st ate m en t to 

th is Sub co m m itte e. I re gre t th a t I cannot ap pear in pe rson . This, ho wev er, in no 

way lessen s ou r de ep in te re st and co nc ern fo r ap pro val of H .R . 3639.

Our o rg an iz at io n re pre se nts p oultry m en in po rtio ns of th re e st ate s loca te d on th e 

D el m ar va Pen in su la — all of Delaw ar e, ni ne E as te rn Sh ore co un tie s of M ar yla nd 

and tw o co un tie s of Virg inia— a m aj or br oi ler-frye r and eg g- pr od uc tion ar ea . M y
62 ANIMAL DRUG AMENDMENTS OF 196 7

personal connection with the poultry industry is as Vice President of O. A. Newton 

and Son C ompany of Bridgeville, Delaware. Our company is an inte grated broiler 

operation. This includes production of hatching eggs, hatchery facilities, feed 

manufacturing and the growing of approximately 13,000,000 broilers annually.

The Delmarva Poultry Industry is an organization of over 5,500 growers, 

hatcherymen, feed manufacturers, poultry processors, equipment dealers and 

other associated business concerns, including a grea t number of civic minded 

citizens who are deeply interested in the imp ortant poultry industry in our area because of the direct relationship i t has to the economy of Delmarva.

On behalf of our organization, I wish to endorse and urge the passage of H .P. 

3639 because we feel this Bill would be of considerable aid to the p oultry industry and to our millions of consumer customers.

Since s hortly after World War I, the Delm arva Peninsula has been a pioneeer 

in the growing of commercial broilers and fryers, and it is generally recognized 

as the birthplace of tod ay’s multi-million dollar broiler-fryer industry. In the 

recent past, Delm arva has begun to diversify with increased productio n of table 

eggs, and many of our members are now in this phase of poultry husbandry. 

Our region, nevertheless, continues as a m ajor broiler growing region and, indeed, Sussex County, Delaware is the nation’s leading broiler growing county.

To give you an idea of how the pou ltry industry has grown, let me point out 

tha t, as recently as 1950, broiler productio n was abo ut 630 million birds; last 

year, it was well over two billion. This means th at broiler productio n has more 

than trebled in the last 15 years. T he average retail price of ready-to-cook broilers has, a t the same time, decreased from 57 cents per pound in 1950 to approximately 

39 cents in 1965—a decrease of abo ut 32%. During this same 15-year period, 

the Bureau of Labor Statistics combined index of all food prices rose from 85.8 

to 108.8—an increase of 26.8%. Today, almost any family can eat a chicken dinner anytime—a nd does, tha nk goodness. Las t year, our average per capita con­ sumption of broilers in the United States was app roxim ately 32 pounds, in contrast 

to only 10.4 pounds 15 years ago. Currently, broilers and fryers account for 

nearly 90% of all chicken meat consumed in our country, in con trast to 42% back in 1950!

The level of progress made in efficiencies of production in the pou ltry industry 

is greater than in any other b ranch of agriculture. There was a time when broilers 

had to eke out their own existence by eating green grass to combine with the 

cracked corn being provided, and to find insects and beetles to provide the protein 

necessary to balance their diet. Broiler rations today provide all the essential 

amino acids, vitam ins, minerals and antibiotics combined in proper proportions 

and f orm ulated by electronic computers. Pou ltry nutrition is a t the highest peak in scientific advancement in the nutrition field.

Not to o many years ago, broiler producers had 15 to 20 percent of their chicks 

die before the y reached ma tur ity. Due to the grea t progress made in disease 

preventio n, it is not unusual for broiler producers to raise 99 to 100 percent of 

the chicks started. Better breeding and managem ent practices are certainly 

important reasons, but even more significant in bringing abo ut these dram atic 

changes are the development and introduction of a variety of feed additives 

and other types of n utritional and therapeutic agents. Such progress has been a 

team effort with nutritio nists, geneticists, poultry pathologists of our Land 

Grant colleges and commercial companies cooperating toward increased effi­ ciencies a nd an improved meat-type bird.

Among commercial efforts, I would like to single out those of the pharmaceutical 

and nutritiona l additive man ufacturers. We have found th at the addition of a 

variety of drugs and nutritional substances to feeds and water increases our 

birds’ rate of gain, decreases the qu antity of feed they must consume to reach 

market weight or maximum egg production, and helps preve nt outbreaks of many 

of the dangerous diseases th at would otherwise at tac k our flocks. With the history 

of v ast increases in knowledge and improvements of our feed and water additives 

in the past decade, we have every reason to hope th at research will continue to 

furnish us even more knowledge and better therapeutic and nut ritio nal agents. 

We at Delm arva Poultry Ind ust ry sincerely hope th at this research and the 

application of its results will not be hampere d by unnecessary restrictions from any sources.

Feed manufac turers in our organ ization have pointed out to me th at under the 

present law one area of control has proved extremely burdensome. On Delmarva 

we make our own feeds, using components furnished by different suppliers. The 

Food an d Drug Adm inistration requires the feed man ufacturer to subm it a medicate d feed application, Form 1800, before we can incorporate a new drug into
ANIMAL DRUG AMENDMENTS OF 19 67 63

any of ou r feeds. H .R . 3639 pr ov id es th a t F.D .A . wou ld be perm it te d on ly 90 

day s to proc ess a feed m anufa ctu re r’s appl ic at io n to in co rp ora te a new dr ug 

in to his feeds. Thi s sin gle asp ec t of th e Bill will be of gre at val ue both to our 

in dust ry and to th e mi llion s of co ns um er s who m we serve.

It seem s a bsu rd t h a t an y g re ate r pe riod of t im e sh ou ld b e ne ce ssary fo r F .D .A .’s 

review of vir tu al ly id en tica l in fo rm at io n th a t ha s al re ad y be en ac ce pte d by 

F .D .A . from th e basic m anufa ctu re r of th e dr ug . Pa ss ag e of th is Bill will re su lt in 

ac ce le ra te d clea ra nc es w hich wi ll be in th e b es t in te re st s of th e pu blic, th e p oult ry 

in dust ry and ou r m em be rshi p.

Scien ce is in de ed in ba ck of ou r gre at poult ry in dust ry and has m ad e it th e 

cr itic al source of feed su pply th a t it is to day. We w ant to co nt in ue to se t new 

re co rd s of a ch ie ve m en t, and we be lie ve th a t th e pa ss ag e of H .R . 3639 is on e st ep 

th a t will he lp th e pe op le of our gre at br oi ler in dust ry as we mo ve fo rw ar d in 

re ac hi ng new goa ls.

I ap pre ci at e th is o pport unit y of ex pressin g our view s co nc erning th is i m port ant 

m att er du ring th is H ea rin g.

S t a te m e n t o f Ab it M a ssey, E x e c u t iv e S ec r e ta r y , G eorgia P oultr y

F ed er a tio n

The Geo rgia P oult ry Fed er at io n is a volu nta ry tr ade as so ciatio n re pr es en ting 

th e gi ga nt ic po ultry in dust ry in Ge orgia. T he Fed er at io n ha s seve n m em be r 

as so ciatio ns : G eo rgia Egg Assoc iatio n, G eo rgia Fe ed A sso cia tio n, G eo rgia H atc hery 

Assoc iatio n, Geo rgia P oult ry Proc essors Assoc iatio n, Geo rgia P oult ry Pro du ce rs 

Assoc iatio n, Geo rgia P oult ry Im pro vem ent Assoc iatio n, an d Geo rgia T urk ey 

Assoc iatio n. I t a lso ha s 341 bu sine ss firm m em be rs an d 2,1 69 in di vi du al m em be rs.

Geo rgia is th e to p st ate in ch icke n pro du ct io n an d th e num be r tw o sta te in 

egg pr od uc tion . P oult ry pr ov id es 41 % of th e to ta l fa rm income in Ge orgia, w ith 

br oi lers th e to p fa rm co m m od ity and eggs follo wing in seco nd pla ce. Geo rg ia ha s 

250 feed mills, 139 ha tc he ries , 38 USD A in sp ec te d poultry proc essin g pla nts an d 

28 US DA gr ad ed egg pr oc essin g pl an ts . In 1966 Geo rgia pr od uc ed 456,1 92 ,00 0 

br oi le r chick en s and 4,5 01 ,00 0,0 00 eggs.

In an effort to de te rm in e th e ite m s of gre ate st in te re st to th e Geo rgia poult ry 

in dust ry , th e Fed er at io n so lic ite d re co m m en da tion s fro m mem be rs an d re ques te d 

discussio ns by m em be r as so ciatio ns an d co m m itte es in ea ch of Geo rg ia’s 10 

Co ng ressiona l D is tr ic ts . Fo llo wi ng this, th e Pub lic Affairs C om m itte e and Boa rd 

of D ire ct or s m et to se lect pri ori ty ite ms.

On e of th e m aj or item s se le cted for th e F edera ti on’s 19 67 -68 P ri ori ty Pub lic 

Af fai rs Pro gr am is as fol low s: “ Support th e A ni m al H ea lth In sti tu te in re ques t 

fo r legi slatio n to co ns ol id at e th e pre m ar ket in g clea ra nc e pr oc ed ur es fo r new 

an im al d rugs , which w ou ld sav e tim e and expe nse, and re du ce costs, wh ile re ta in in g 

ne ce ssary st andard s of sa fe ty .”

T his re it era te s a sim ila r po si tion ex pr es se d by th e Fed era ti on and Geo rgia 

poult ry in dust ry on se ve ra l oc ca sio ns, in cl ud in g a st ro ng re so lu tion pa ss ed un an imou sly a t th e A nn ua l M ee ting of th e Fed er at io n on April 15, 1967.

The F eder at io n be lie ve s th ere is an urg en t ne ed fo r legi slatio n to simpl ify th e 

pr oc ed ur e for clea rin g new dr ug s fo r use by th e poult ry in dust ry . I t has be en 

ca lle d to ou r att en ti o n th a t in some ca ses it is mor e co m pl ic at ed an d tim e co nsu m in g to o bta in clea ra nc e fo r ne w dr ug s fo r poultry an d liv es to ck th a n for 

hu m an s.

D r. Malco m Reid, Pro fe ss or and P ar as itolo gis t a t th e D epart m ent of P oult ry 

Scien ce a t th e U ni ve rs ity of Geo rgia, ad vi se s us th a t tw o new co cc id io stat s sho w 

un us ua l efficac y again st all ni ne species of co ccidios is wh ich ca n be co stly to 

poult ry pr od uc er s. W hile po u lt ry pr od uc er s in Geo rgia and oth er p a rt s of th e 

U nited S ta te s w ai t, one of th e pro duct s has be en in use in E ngla nd sin ce Se pte m ber of la st yea r and in A ust ra lia sin ce Ja n u ary . One co m pa ny w en t to W as hin gto n w ith 22 po un ds of cros s re fe re nc ed pap er w ork an d th e oth er ca rr ie d 46 

pou nd s in sin gle co py in an effo rt to ge t clea ra nc e for use in th is co untr y.

The F ed er at io n stro ng ly s upport s legislation su ch a s H .R . 3639 by C on gr es sm an 

Jo hn J arm an o f Oklah om a, H .R . 8431 by Con gr es sm an Phi l L an dru m of Ge orgia, 

H .R . 876 0 by Con gr es sm an M as to n O ’N ea l of G eo rgia, a n d H .R . 9002 by C on gr es s 

m an R ober t Ste ph en s of Georgia.

T his le gi slatio n wou ld co ns ol id at e th re e se para te se ctions of law an d sa ve 

tim e and ex pense. I t w’oul d en co ur ag e re se ar ch on new poult ry dr ug s an d m ak e 

new de ve lo pm en ts an d discov eries av ai la bl e soon er. It wou ld be ne fit feed m an ufa ct ur er s, dr ug m an ufa ctu re rs and dis trib uto rs , an d poult ry an d egg pr od uc er s, 

proc esso rs and co ns um ers.

We ho pe th e su bc om m itte e will su bm it a fa vora ble re port and wor k fo r th e 

ea rly pa ssag e of th is ne ed ed leg islatio n.
64 ANIMAL DRUG AMENDMENTS OF 19 67

Wisconsin State Department of Agriculture,

Madiso n, lU/s., September 26, 1967. Hon. J ohn J arman,

Chairman, Subcommittee of Health and Welfare, House Interstate and Foreign

Commerce Committee, House Office Building , Washington, D.C.

Dear Congressman J arman: It is my understanding th at you will be hearing 

and taking action on the important legislation which will go far toward clarification and consolidation of the Federal Food, Drug, and Cosmetic Act in regulating 

premarketing clearance on new animal drugs.

The National Association of S tate Depar tments of Agriculture have instructed 

me, as c hairm an of our Animal Health Committe e, to make their position known 

as favoring immediate passage of this legislation. It is very im porta nt for the 

long-range development and continuation of our anim al-type agriculture of this 

country.

There have been a few questions raised many months ago concerning the need 

and desirability of this legislation. We hope, however, th at all of these early 

questions have been resolved and that this legislation would be both essential 

and workable in the best interests of the American people. We urge y our su pport 

and assistance in expediting the early passage and American agricultu re and the 

food industry will be grate ful for your work.

Sincerely,

D. N. McDowell, 

Secretary of Agricu lture.

The Proprietary Association,

PFosZimgrion, D.C., October 4, 1967. Hon. J ohn J arman,

Chairman, Subcommittee on Public Health and Welfare,

Committee on Interstate and Foreign Commerce,

House of Representatives, Was hington, D.C.

Dear Mr. Chairman: This letter is in reference to H.R . 3639 and related 

bills, identified as the “Animal Drug Amendments of 1967”, and is subm itted 

with the request that it be made a part of the record of hearings on the bill. This 

Association desires to be recorded in su ppo rt of the proposed legislation. Its position was duly authorized by its Exec utive Committee (the governing body).

The Proprie tary Association has its offices at 1700 Pennsylvania Avenue, N.W., 

in the city of Washington. It was organized in 1881 and has been in continuous 

existence ever since. Its activ e members— ninety-five in number—are engaged in 

the manufacture and distribution of proprie tary medicines—medicines which 

are completely compounded, packaged, labeled with directions for use and advertised directly to the public. They are over-the-counter items; items which are not 

restricted by law or practice to prescription sale.

While the greater volume of the medicines produced by members of this Association are for use in human medication, some of the members do make drugs for use 

in the medication of animals and are therefore interested in and would be affected 

by the purposes and provisions of the subject legislation.

The emphasis in food and drug legislation has unde rstandably been on regulation of drugs for human use. Animal drugs have always been regulated under this 

law but they have been of secondary concern. H.R . 3639 et al. would pu t in 

better balance the law’s regulation applicable to human and animal drugs. It 

would simplify the regulation by coordinating controls currently imposed on 

animal drugs by several sections of the existing law. It would provide a single 

procedure for clearance of animal drugs. A single section for this purpose, inserted 

into the Federal Food, Drug and Cosmetic Act, would follow the pattern of 

regulation which perta ins now to new drugs and antibiotic drugs for human consumption. The bill also applies to animal feeds which bear or contain new animal 

drugs.

An imp orta nt purpose of the bill is to preven t delays in the introduction of 

new animal drugs and to facilitate the availability of them. It would thereby 

encourage development of new animal drugs which are needed to fight food losses 

which are presently at a high rat e due to disease.

Therefore, this Association heartily subscribes to the purposes of H.R . 3639 

et al. and recommends the bills as capable of accomplishing them.

Respectfully subm itted.

J ames D. Cope,

Executive Vice President and Treasurer.
ANIMAL DRUG AMENDMENTS OF 19 67 65

P har m a c eu tic a l M a n u fa c t u r e r s A sso c ia tio n,

If ashin gto n, D.C ., October 10, 1967 .

Re H .R . 3639, 90 th Co ng res s.

Hon . J oh n J arm an,

Ch air ma n, Sub comm itte e on Pub lic He alth an d We lfare,

U .S . Ho use of R epr ese nta tives, W ashington , D.C.

D ea r M r. C h a ir m a n : On be ha lf of th e Phar m aceuti cal M anufa ct ure rs Associ at io n, th is le tt er is s ubm it te d in su pport of H .R . 363 9, a bil l to a m en d th e Fed er al 

Fo od , D ru g and Cos metic Act, which is un de r co ns id er at io n by you r Su bc om ­

m itte e follow ing he ar in gs on it on Octob er 3.

T he PM A is a nat io nal or ga niz at io n re pre se nting m anufa ct ure rs pr od uc in g 

about 95 per ce nt of th e n ati o n ’s o u tp u t of pre sc ript io n dr ug s. O ur in te re st in th is 

legi slatio n stem s fr om th e fa ct th a t it co nc erns th e pu bl ic hea lt h and pr op os es 

am endm ent to th e Fed er al Fo od , Dru g an d Co sm etic Ac t.

W ith b u t on e ex ce pt io n, H .R . 3639 is id en tica l to a pred ec es so r mea su re in th e 

E ig hty -n in th Con gr es s which th is Assoc iatio n als o su ppo rt ed . T he dif ferenc e 

be tw ee n th em is th a t H .R . 3639 pr ov id es for an effecti ve d ate of tw elve m onth s 

aft er en actm ent ra th er th an th e six m on th s pro vid ed fo r in th e pr ed ec es so r 

mea su re. Thi s long er pe rio d, I am ad vise d, is ac ce pta ble to in dust ry an d also to 

th e Fed er al Fo od an d D ru g A dm in is trat io n.

The pr in ci pa l pu rp os e of th is bill is to co ns ol id at e an d st re am line in a sin gle 

new se ct io n of th e Fed er al Fo od , D ru g and Co sm etic Act of th e pre m ar ket in g 

clea ra nc e se ctions o f th e e xi stin g law wh ich ar e ap pl ic ab le to new an im al dr ug s or 

to an im al feeds cont ai ni ng su ch drug s. Th is pro ce du ra l sim pl ic at io n is m an ifes tly 

de sira ble and in th e pu blic in te re st . Moreo ve r, it wou ld be ac hi ev ed w ithout 

re du ci ng th e rig id co nt ro ls now sa fe gu ar ding th e pu bl ic healt h whi ch ar e pre se nt 

in th e ex istin g law .

Sin ce it s in ce pt ion, re gul at io n of dr ug s for hum an use has be en th e ch ief o bj ec ­

tive of th e Fed er al Fo od , Dru g and Co sm etic Ac t. As a co ns eq ue nc e, th e Act ha s 

clea rly e st ab lish ed pr oc ed ur es f or h an dl in g hum an dr ug s. On th e oth er han d, ev en 

th ough an im al dr ug s ha ve alway s been re gu la te d under th e Act, th ey ha ve gen ­

er al ly be en ac co rd ed on ly se co nd ar y tr eatm ent, espe cially in th e iss ua nc e of re gulation s. The enactm ent of th is leg islatio n, ther ef or e, wo uld en ab le th e Co ng ress 

to e xp re ss its in te n t th a t th e clea ranc e and r eg ul at io n of new an im al dr ug s sh ou ld 

be ba se d on pr oc ed ur es solely ap pl ic ab le to suc h dr ug s.

F urt her, it wou ld cu re th e de fe ct s of ex istin g m ultip le co nt ro ls by co ns ol id at in g 

in to a sin gle new se ction th e pre se nt dive rse an d ov er la pp in g cle aran ce se ct io ns 

of th e Act. The new sin gle cle aran ce proc ed ur e wh ich th is bil l prop os es will 

re du ce de lays in th e in tr od uc tion of new an im al dr ug s, will fa ci lita te th ei r avail ­

ability and use follo wing disc ov ery an d de ve lopm en t, will fre e more fu nd s for 

in ves tm en t in basic re se ar ch , and will a id t hi s c ountr y in incr ea sing its p ro ducti vit y 

to m ee t th e fu tu re de m an ds fo r mo re m ea t, milk , an d eggs which will com e fro m 

our ra pi dl y increa sing po pu la tion.

I t w ou ld be ap pre ci at ed if yo u wo uld includ e th is l ett er in your Subco m m itte e’s 

reco rd of yo ur pr oc ee ding s on th is bill.

Sincerely ,

C. J o se ph St e t l e r , P resid en t.

G r a in & F ee d D ea ler s N ati o na l Asso c ia tio n,

Wa shing ton , D. C., October 5, 1967.

Hon . J ohn J arm an,

Ch air ma n, Sub com mittee on He alth an d Wel fare , Int ersta te an d Foreig n Commerce

Committee, Ho use of R epr ese nta tive s, Wa shington, D.C .

D ea r M r . J a rm a n: The G ra in and Fe ed D ea ler s N at io nal A ssoc iatio n ha s 1,700 

direc t mem be rs rang in g in size from th e sm allest co untr y el ev at or s and fee d mills 

to th e la rg es t grain and fee d comp lex es. In ad di tion , th er e ar e fifty -fou r st ate or 

region al as so ciations which are affiliated w ith th is N at io nal Assoc iatio n an d which 

ha ve about 17,000 mem be rs.

The G ra in an d Fee d Dea lers N ational As sociati on wou ld like to go on reco rd as 

favo ring th e pa ssag e of H .R . 3639. We belie ve th a t th e co ns ol idation of law s perta in in g to an im al dr ug s wou ld re m ov e co nfusion from ex istin g law . Furt her m ore , 

th e simplifi ca tio n of clea ranc es fo r an im al dr ug s wo uld be ne fit th e gr ain an d feed 

in dust ry w ith no ad ve rs e eff ect on hum an co nsum ers. We, th er ef or e, ur ge th e 

pa ssag e of H .R . 3639 .

Sinc erely yo urs ,

Alv in E. Ol iv e r, 

Execu tive Vic e Presi dent.
66 ANIMAL DRUG AMENDMENTS OF 19 67

D e p a r t m e n t o f H ea l t h , E d u c a tio n, an d W e l f a r e,

F ood an d D ru g A d m in is tr a tio n ,

Washington, D.C., November 1, 1967. Hon. A n c h e r N e l s e n ,

Subcommittee on Public Health and Safety, Committee on Interstate and Foreign

Commerce, House of Representatives, Washington, D.C.

D ea r M r . N e l s e n : This is in response to a request by Mr. Menger of the 

committee staff for further comm ent on a discussion paper which was attach ed 

to your l etter of October 4 to the Food and Dru g Administration regarding H.R. 

3639.

This paper asserts th at if preclearance controls are necessary over feeds containing “ne w” drugs, then preclearance is likewise necessary for feeds containing 

“old” drugs. However, it m ust be borne in mind t ha t “old” drugs are, by definition 

drugs which are generally recognized as safe and effective for their intended use. 

Therefore, the same degree of precautio n is n ot mandato ry for old drugs in order 

to protect the public health.

The comparison between feed man ufac turers and pharmacists in the paper is 

not a good one. Pharm acists are extensively trained in various drug matters 

including drug compounding and are licensed, whereas most feed manufacturers 

are no t so trained and usually not licensed. Man ufac turers of drugs for human 

use, including pharmacists if they engage in inters tate business, are sub ject to 

the new drug requirements of the Food, Drug, and Cosmetic Act.

We cannot agree with the assertion in the discussion paper th at one of the 

bill’s provisions “finally slams the door in the face of s tate regulatory officials.” 

There is nothing in H.R. 3639 th at would curb existing State autho rity and it is 

our purpose, whether or not the bill is enacted, to continue to strengthen State 

activities in this area by commissioning Sta te officials, pursuan t to Section 702(a) 

of the Act.

If we can be of further assistance, please let us know.

Sincerely yours,

W. B. R a n k in ,

Deputy Commissioner.

(Whereupon, at 11:50 a.m., the hearing was adjourned.)

o