Chemicals in Our Food can Cause Cancer (Aramite Chemical Speech), Statement, 1958 April

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6994

rehabilitation of the disabled. As one
step in this direction, Congress required
the States in 1950 to exempt $50 of
earned income of blind aid recipients
from consideration in determining the
amount of the grant. As a second step,

Congress in 1956 proclaimed self-care

and self-support to be one of the pur-

poses of the public assistance provisions
of the Social Security Act.

Sixth. This bill, if enacted into law,
would simply restore an important
States right—the right to provide at
State expense, a more liberal program of
aid to the blind than the Federal Gov-
ernment chooses to allow. Since under
the provisions of this legislation, the
Federal Government would only provide
participating funds for those individuals
who would qualify under the present
strict Federal definition of need, the plan
could not possibly increase the cost to
the Federal Government. It would in
fact in time provide a real financial
benefit to the Federal Government.
Through more liberal State financed
welfare programs geared to rehabilita-
tion and self-support, more blind people
will make their way off of the relief rolls
and will encourage our nonsighted citi-
zens to make the most of their produc-
tive years, and by so doing, to become
more useful citizens.

The text of the bill is as follows:

A bill to amend title X of the Social Secu-
rity Act to provide that, without an in-
crease of Federal participating funds, a
State plan for aid to the blind may utilize
® more liberal needs test than that pres-
ently specified in such title
Be it enacted, etc., That (a) clause (8) of

section 1002 (a) of the Social Security Act

is amended by inserting after “provide” the -

following: “(unless this clause is inappli-
cable by reason of the last sentence of this
subsection) .”

(b) Section 1002 (a) of such act is further
amended by adding at the end thereof the
foliowing new sentence: “A State plan for
aid to the blind shall not be required to
meet the requirements of clause (8) if in
lieu thereof it provides that the State agency,
in determining need, shall take into consid-
eration less of the other income and re-
sources of the individual claiming aid to the
blind than would be required to be consid-
ered under claus (8) or shall disregard more
than the first $50 per month of earned in-
come, or that the State agency shall pay a
fixed sum to all individuals eligible for aid
to the blind; but payments under section
1003 shall be made, in the case of any such
plan, only with respect to expenditures
thereunder which would be included as ex-
penditures for the purposes of section 1003 if
the plan met the requirements of clause (8) .”

Sec. 2. (a) The amendments made by this
act shall be effective on and after July 1,
1959.

(b) Effective July 1, 1959, section 344. of
the Soical Security Act Amendments of 1950
is repealed,

NATIONAL RADIO MONTH AND THE
FIRST AMENDMENT

(Mr. McCORMACK asked and was
given permission to address the House
for 10 minutes and to revise and extend
his remarks.)

Mr. McCORMACK. Mr. Speaker, ra-
dio was undreamed of when this coun-
try was founded. Yet today it holds
major meaning and may be said to be
the very breath of life in the first

CONGRESSIONAL RECORD — HOUSE

amendment to the Constitution of the
United States. When the Constitution
enjoins the Congress from making any
law abridging the freedom of speech it
extends the infinite blessings of this
prohibition by the very nature of things
to the electronic miracles of communi-
cation. Without electronic communica-
tion, as we live today, it is almost im-
possible to think either of the demo-
cratic process or modern civilization in
the free world.

It is for these reasons that I attach
such great importance to National
Radio Month during May. I say “great
importance” because the dignity of man
is interwoven profoundly in the rela-
tionship of a people and their Govern-
ment. Government—Federal, State, lo-
cal—has been brought into such inti-
mate contact with the people that the
thongs of freedom, of government by
consent, and government by participa-
tion of the citizen in the decisions of
government, have been strengthened as
much by radio, as formerly they were
strengthened by the invention of the
printing press.

Radio stands out as a phenomenon
unparalleled in its time, unless it is by
TV, in the acceleration of modern in-
dustrial progress. All mankind bene-
fited from an enlightened conspiracy
among science, invention, capitalism,
and free enterprise. Under democratic
government these combined in the
United States to bring the impact of
this instrument we call radio to such
fruition that in a matter of a few dec-
ades hardly an ear among 172 millions
of- Americans is not—at the turn of a
dial—within hearing of some broadcast-
ing station, some network, some sound
carrying with it news or entertainment,
information or instruction, edification
or the advertising that helps to keep
our economy dynamic.

A self-governed people can never in
the future say that inadequate communi-
cation was responsible for any of its ills.

Of course in the diversity of projects
so all-enveloping as radio there are
flaws. The burden now is upon those
who manage and manipulate communi-
cations. It is in this connection that
I would like to take this opportunity to
congratulate the radio industry proper
and the National Association of Broad-
casters for a job that is on the whole
commendable. I know they join me in
the hope of even greater improvement
in the future. The slow but constantly
advancing character of betterment in
their management indicates their aware-
ness of the problems involved in the
monumental responsibility that falls
upon them with compelling directness.

Statistically emphasis, even repetition,
should be given to the fact that 97 per-
cent of all homes in America are radio
equipped. There are 150 million radio
sets in the United States distributed
among our people. In fact in the rural
areas practically every home has its
radio. I am reliably informed that 66
million people listen daily to the radio.
In 1 month this durable, tireless, rela-
tively inexpensive device, in its way over
a period of time even less expensive than
our newspapers, reaches no less than al-

April 30

most 90 percent of t: ult popu-
lation of our country. let me
add, is no replacement and no substitute
for the home newspaper, but it is cer-
tainly a remarkable complement to
printed journalism, and an enormous
source of public information in its own
right.

In the face of this revolutionary
change in communication we have to re-
flect that the idea of the transmission
and reception of signals by means of
electric waves without a connecting wire
was once called radiotelegraphy or
radiotelephony and in its current state
of development is quite within the
memory of contemporary man. Its
theoretical origins go back to 1864, and
then to 1887, bringing up such names
respectively as Clerk-Maxwell and Prof.
H. Hertz. Later with further discov-
eries came Edouard Branly and Sir
Oliver Lodge. Finally Guglielmo Mar-
coni in 1895 applied these theories prac-
tically until in 1901 he signaled the
letter “S’” across the Atlantic.

The following year—1902—the world
heard the first transatlantic message by
wireless. "

Then came the electron tube in con-
nection with which such names are
notable as that of Fleming, DeForest,
and Langmuir, Radio moved out of the
mind of man into the laboratory. It
then drove with positively massive re-
sults into the factory providing a vast
new source of wealth altogether apart
from its services as an instrument of
communication to the whole of mankind.
The radio industry today has jumped
from the production of 12 million re--
ceiving sets in 1940 to 55 million in 1951,
according to 1 research organization,
and 53 million in 1957. If we unite radio
manufacture with radio broadcasting
we have, of course, an American industry
of the first magnitude, and industry that
only began to exist after World War I.
When I speak of the acceleration of in=
dustry under capitalism and free enter-
prise and democratic government this
is what I mean, :

Research that I had instituted for this
statement reveals a wealth of further -
data that is, on the whole, illustrative of
superior management by private indus-

‘try and, with the usual exceptions, en-

lightened regulation by Government.
All this was achieved without enslaving
our scientists, without bribing them,
without segregating them, and without
intimidating them. They and the in-
dustrialists and financiers and entrepe-
neurs who followed them, and the tens of
thousands of employees in the field, made
their enormous cumulative contribution
to civilization and the democratic proc-
ess as free men and women. We do not
claim radio as a totally American idea as
Ihave shown. The genius of man from
varied backgrounds and cultures, under
our flag and under other flags, gave us
this great gift. But I like to think that
under free government here or in West-
ern Europe or anywhere the genius of
man gets its freest play for the good of
all, I like to think that this is done
under a policy that does not push science
and does not subject it to the indignity
of either compulsion or of sudden fiat-

, prior to the new
FDA

ved:

The precedent established by the Aramite
decision has opened the door, even if only
a little, to the use of carcinogens in our
foods. That door should be slammed shut
and locked,

It is my firm purpose to do just that.

Surely there is nothing of greater im-
portance to any nation than the health
of its people.

We have a serious responsibility in
this field. It is urgent that we meet it
as soon as possible, and as completely as
possible.

AMENDMENT OF SOCIAL
SECURITY ACT

(Mr. CURTIS of Missouri, at the re-
quest of Mr. Teacue of California, was
given permission to extend his remarks
at this point in the Recorp.)

Mr. CURTIS of Missouri. Mr. Speak-
er, I have introduced today a bill to
amend title X of the Social Security Act
to provide that, without an increase in
the Federal participating funds, a State
plan for aid to the blind may utilize a
more liberal-needs test than that pres-
ently specified in such title. This bill is
consonant with the spirit and avowed
purposes of title X wherein enabling leg-
islation was enacted to encourage each
State “to furnish financial assistance as
far as practicable under the conditions
of such State, to needy individuals who
are blind and of encouraging each State,
as far as practicable under such condi-
tions, to help such individuals attain
self-support or self-care.”

Title X of the Social Security Act pro-
vides grants to States for aid to the
blind. The grants cover four-fifths of
blind-aid payments up to $30 per month
and one-half above $30 not to exceed $60
per month. Accordingly, under a State
plan for aid to the blind that qualifies
for a title X grant, the Federal Govern-
ment pays out $39 out of a $60 per
month blind-aid payment.

Title X has been in effect since 1935.
Since 1950, all 48 States have had plans
which qualify for Federal reimburse-
ment. Prior to 1950, however, Missouri
and Pennsylvania had in effect laid
plans for the blind which had failed to
conform to the Federal interpretation of
the so-called needs test amendment of
1939. That amendment provided: “A
State agency shall, in determining need,
take into consideration any other in-
come and resources of an individual
claiming aid to the blind”—-section 1002
(a) (8). From 1937 to 1950 the blind
people of Missouri and Pennsylvania and
their State legislatures consistently re-
fused to accept Federal matching funds
if it meant scrapping their more liberal
State blind pension and enacting in lieu
thereof a more restrictive law which
would conform to Federal requirements.

In 1950 Congress approved special
legislation which permitted Missouri
and Pennsylvania to retain their more
liberal aid to the blind programs and
still receive Federal participating funds.
Under this special provision, the Fed-
eral Government provides participating

No. 68——14

CONGRESSIONAL RECORD — HOUSE

funds only for those individuals who
meet the strict requirements of the
Federal law. The remaining eligible
blind people of Missouri and Pennsyl-
vania are paid entirely from State
money. The exact language of the
amendment reads:

In the case of any State * * * which did
not have on January 1, 1949, a State plan
for aid to the blind approved under title
xX, * * * the Administrator shall approve
a@ plan of such State for aid to the blind for
the purposes of this title X, even though it
does not meet the requirements of clause
(8) of subsection (a), if it meets all other
requirements of title X for an approved
plan for aid to the blind; but payments
under section 1003 shall be made, in the
case of any such plan, only with respect to
expenditures thereunder which would be

included as expenditures for the purposes _

of section 1003 under a plan approved under
title X without regard to the provisions of
this section.

The amendment to the Social Secu-
rity Act was originally enacted to termi-
nate on June 30, 1955. Its life has
since been twice extended, first to June
30, 1957, and now to June 30, 1959. The
bill which I have just introduced pro-
poses a solution that will put to rest,
once and for all, the issues presented by
the Missouri and Pennsylvania plans.
Accordingly, this bill is proposed to take
effect on July 1, 1959.

The Missouri and Pennsylvania pro-
grams are primarily more liberal than
Federal requirements in the following
regards:

One. Missouri has two separate plans,
one plan which is supported entirely by
State funds, provides for those blind
persons who meet the eligibility re-
quirements of the State law, but do not
meet the more restrictive requirements
of the Federal law. The other plan is
supported by Federal and State par-
ticipating funds and provides only for
those persons who meet the more strict
Federal definition of need. Pennsyl-
vania has only one plan but the Federal
eligible and ineligible recipients are
separated as a bookkeeping transaction.

Second. In Missouri and Pennsyl-
vania a flat fixed amount of $60 is paid
to each recipient each month. This is
in contrast to the variable individual
payments of the Federal law.

Third. In Missouri a blind person is
allowed to earn $175 a month and still
qualify for the full amount of the pen-
sion while under present Federal law
only $50 per month is allowed as exempt
earnings. In Pennsylvania a blind per-
son is allowed to earn $148.33 and still
qualify for the full amount of the grant.

Fourth. In Missouri and Pennsyl-
vania the amount of cash and property
that a blind person may have and still
qualify for the full pension is more lib-
eral than under the Federal provisions,

nities to the end that they may render —

themselves independent of public as-
sistance and become entirely self-sup-

6993

porting. These programs have proved
highly successful and have paved the
way for more enlightened socio-econom-
ic legislation in the other 46 States. I
have. long been impressed with the wis-
dom of the words of Justice Brandeis
who said “it is one of the happy in-
cidents of the Federal system that a
single courageous State may, if its cit-
izens choose, serve as a laboratory; and
try novel and economic experiments
without risk to the rest of the country.”
The value of this thesis is demonstrated
by the Missouri and Pennsylvania plans.
Our aid to the blind program should be
directed to the ends of rehabilitation
and helping our nonsighted people to
become useful and productive citizens.
The above described needs test tends to
hurt our efforts at rehabilitation. Its
effect is to destroy initiative and desire
to make the most of the blind’s produc-
tive years. The bill which I have in-
troduced today is intended to preserve
the minimum standards of clause (8)
but it still allows the States to develop
their programs in accordance with mod-
ern thinking and to encourage more lib-
eral provisions provided that the States
are willing to finance their expanded
programs out of State funds.

This bill, then, would resolve the fol-
lowing Federal-State issues which have
been raised by the present title X of the
Social Security Act, to wit:

First. It would preserve to the States
their right to provide improved social-
welfare programs for the blind wholly
financed out of State funds.

Second. It makes it possible for Mis-
souri and Pennsylvania to retain perma-
nently, and for other States to adopt, if
they wish to do so, any or all of the dis-
tinctive features of the Missouri-Penn-
sylvania plan of aid to the blind.

Third. The amount of each State’s
Federal grant would continue to be meas-
ured by the present standards and on
like terms to all States. The definition
of the means test that is contained in
clause (8) of section 1002 (a) would ap-
ply to all States for the purpose of deter-
mining the part of any State’s expendi-
tures that will be covered by the Federal
grant.

Fourth. No limitation or requirement
on the allowable exceptions from the
means test in the direction of greater
liberality would be imposed upon ‘any
State plan in order to retain a title X
Federal grant for federally eligible cases.
In order to prevent the States from cir-
cumventing the minimum standards of
the Federal program by transferring
recipients to a drastically less adequate
State program, the States are permitted
to increase, but not decrease the extent
to which the recipients’ earnings, or in-
come, or other resources will be accepted
from the means test.

Fifth. It would eliminate the forced
conformance to the antiquated needs
test and would certainly encourage the
other 46 States to develop plans that are
consonant with this desirable thesis of
rehabilitation and self-help. It would
further bring Federal public assistance
policy into conformity with the new
congressional and general emphasis on

6992

million on certain other raw agricultural
commodities.

After consideration of the test data
submitted, which included evidence that
the chemical induced malignant tumors
in test animals, FDA concluded that the
safety of Aramite was questionable, and
published a zero tolerance.

Thereupon, the United States Rub-
ber Co. withdrew its original petition
and submitted a new petition requesting
tolerances for Aramite of 1 part per mil-
lion in or on the same commodities. In
conformance with a certain provision
of the pesticide amendment, the com-
pany also requested that the new
petition be referred to an advisory com-
mittee of experts for study and recom-
mendations.

This committee met in Washington on
July 27, 1955, and following a morning
and an afternoon session, issued three
recommendations:

1. That a residue tolerance of 1 part per
million be established for aramite under the
provisions of Public Law 518, 83d Congress.

However, the committee apparently
was not convinced that aramite was
harmless, because it also recommended:

2. That the petitioner be advised to secure
acceptable data on the chronic toxicity and
carcinogenicity of aramite at feeding levels
between zero and 500 parts per million in the
mouse, rat, and dog.

3. That the entire problem be reviewed by
this or another committee in 1957, when fur-
ther laboratory and other data are available.

These, surely, were strange recom-
mendations for scientists tomake. They
admitted that they felt that the data
which they reviewed were insufficient
and incomplete, and, in particular, sug-
gested that more information be secured
regarding the cancer inducing propen-
sities of aramite. Yet, at the same time,
they were perfectly willing that the pub-
lic be exposed to a certain amount of it.

It is all the more strange when we
consider that the committee had before
it reports of tests which showed that
aramite, when fed in certain concentra-
tions, produced liver injury and malig-
nant tumors in test animals.

The Food and Drug Administration
accepted the recommendations of the
advisory committee, withdrew its previ-
ous ruling, and published a tolerance of
1 part per million of aramite. Once
again, as so often in the past, the public
became a guinea pig.

Now, over two and a half years later,
additional tests show that aramite, fed
at a significantly lower concentration
than that considered by the advisory
committee, tended to cause liver tumors
in rats, and produced liver damage and
malignant tumors in the livers and bile
ducts of dogs.

Here, it seems to me, is a perfect ex-
ample of the apparent willingness of
government to accommodate big busi-
ness and let the public take the risk.

At the time of its original ruling, the
Food and Drug Administration had on
hand evidence to show that aramite, so
far as the public health was concerned,
was at least a suspicious product. Under
the law, FDA was not required to accept
the recommendations of the advisory

CONGRESSIONAL RECORD — HOUSE

committee and grant any tolerance of
the chemical.

The Food and Drug Administration is
to be commended on admitting its mis-
take and publishing its present proposed
ruling. However, that does not remove
the possible effect that aramite may have
had on the public during the period in
which its residues have been permitted.

Mr. Speaker, the significance of FDA’s
former ruling on Aramite was that for
the first time a precedent was set that
might give legal sanction to the intro-
duction of so-called “safe” quantities of
cancer-inciting additives into food.

I first brought this to the attention of
the Congress on February 21, 1957, when
I placed in the CoNGRESSIONAL RECORD a
letter written to me by a noted cancer
researcher, Dr. William E. Smith.

Dr. Smith has had a brilliant research
career and at various times has been
on the staffs of the Harvard Medical
School, the Rockefeller Institute for
Medical Research, the Sloan-Kettering
Institute for Cancer Research, and was
at one time an associate professor of in-
dustrial medicine at New York Univer-
sity. At present, he is doing research at
the Fairleigh Dickinson University and
is secretary of the Cancer Prevention
Committee. Dr. Smith is a dedicated
scientist, and a courageous man who has
not hesitated to tangle with the indus-
tries in attacking practices which he has
felt might endanger the public health.

It was after several discussions and
much correspondence with Dr. Smith
that I revised my earlier food additive
bill, H. R. 4014, and introduced H. R.
7798, which contains the carcinogen
prohibition, and is the only additive bill
which does so, except for an identical
bill, H. R. 7938, introduced by the dis-
tinguished gentlewomen from Missouri
(Mrs, SuLtivan],

Here I should like to pause a moment
to express my appreciation for the strong
support that our much admired col-
league from St. Louis has given in this
food additive issue. She has spoken
eloquently on the floor of the House on
this subject, has given radio talks, has
conferred with women’s groups and con-~
sumer organizations. Her interest and
concern have been a most valuable con-
tribution.

The carcinogen provision, which I
have mentioned, follows the unanimous
recommendation of the International
Union Against Cancer at its symposium
in Rome in August 1956. This sym-
posium was attended by over 40 cancer
experts from some 20 countries,

The recommendation stated:

The conference recommends that, as a
basis for active cancer prevention, the proper
authorities of various countries promulgate
and enact adequate rules and regulations

prohibiting the addition to food of sub-
stances having potential carcinogenicity.

The two following recommendations
were also unanimously approved:

1, Food additives should be permitted
only if, after long-term administration to
at least two species of animais (one prefer-
ably a nonrodent), orally and parenterally, in
amounts which must be considerably higher
than would be present in food, and, after
observation of the animals over their life-

April 30

time, and through at least two generations
in at least one suitable species, they have
no toxic effect.

2. Any substance which causes cancer in
man or which, when tested under these con-
ditions, is shown conclusively to be a car-
cinogen at any dosage level, for any species
of animal, following administration by any
route, should not be considered innocuous
for human consumption.

The original tests showed that Ara-
mite did not meet these criteria of
safety. The later tests were even more
conclusive regarding its potentiality for
harm. Of course, the International
Union Against Cancer is not an Ameri-
can organization, although some distin-
guished Americans are members of it,
but it does represent the advanced
thinking of a world group of cancer au-
thorities.

H. R. 7798 not only follows the recom-
mendations of the International Union
Against Cancer but also conforms with
recommendations of the American Can-
cer Society.

A letter sent to the Subcommittee on
Health and Science on July 22, 1957, by
Mr. James S. Adams, chairman of the
legislative committee of the American
Cancer Society, states as follows:

We strongly urge that your committee rec-
ommend iegislation to the Congress to
strengthen the Food and Drug Administra-
tion and that this legislation embrace the
following principles:

1. That the proponent of any proposed
chemical additive be required to conduct
tests which will demonstrate that the addi-
tive is safe for human consumption in the
manner in which it will be used, and that
these tests include one to determine whether
the additive may be carcinogenic to experi-
mental animals. The adequacy of these
tests should be determined by the Food and
Drug Administration.

2. That permission to use the additive be
withheld until its safety has been demon-
strated to the satisfaction of the Food and
Drug Administration by the proponent.

83. That no substance shall be approved
found to induce cancer in man, or after tests
provided in No. 1 above, found to induce
cancer in animals,

H. R. 7798 is supported by such au-
thorities as Dr. William C. Hueper, the
distinguished head of the Environmental
Cancer Section of the National Cancer
Institute, who testified before the com-
mittee in an unofficial capacity; Dr.
Francis E. Ray, director of the cancer
research laboratory of the University of
Florida; Dr. Alton Ochsner, head of the
Ochsner Clinic of New Orleans, and a
famous cancer surgeon; and Dr. W. Coda
Martin, president of the American Acad-
emy of Nutrition. It is also supported
by a very large number of consumer or-
ganizations and labor unions, members

of which have a direct interest as con-
sumers.

Mr. Speaker, it is appalling to think
that 1 out of every 4 persons in this
country will at some time or another
suffer from cancer. While we may not
yet completely understand the part that
chemical additives play in the cancer
picture, enough is known to put us on
our guard.

In my last appearance before the
Health and Science Subcommittee on the

his leadership in matters pertaining to
Illinois transcends party lines. It is not
unusual for the entire Illinois groups,
Democrats and Republicans, to assemble
in Tom’s office for guidance on impor-
tant legislation which means so much to
the development of the Chicago area and
to the welfare of the people of Illinois.

His interests, however, are not limited
to his own district, nor his own State. He
is forever in the forefront of progressive
legislation in the national interest, and
his vast reservoir of knowledge gained
through his many years of public service
is readily made available by him to
others.

So, this afternoon, it is a distinct
pleasure to join my colleagues in saying,
“Happy birthday” to Tom O’Brien. My
sincere best wishes go with the greeting,
as I express the hope I may have the
good fortune to look to this distinguished
leader from many years for advice and
counsel.

Mr. BOYLE. Mr. Speaker, both as a
personal friend of long standing and as
a member of the Illinois delegation, it is
my distinct honor to take the floor and
salute, congratulate, and compliment the
great dean of the Illinois delegation,
Tuomas J. O’Brien, on the occasion of
his 80th birthday.

Starting his career of public service
as a constable in 1906, he has spent a
lifetime in serving his fellow men.
Through the years he has devoted his
time and energy in rendering an honor-
able account of his stewardship.

With God on his side and the winds of
good health in his sails, may a kindly
providence reward our dean for his many
accomplishments and favor him with
many more years in which to continue
his fine leadership of the Illinois delega-
tion. We wish him many happy returns
of the day.

SOUND SCHOOL-AID LEGISLATION

(Mr. UDALL asked and was given per-
mission to address the House for 1 min-
ute and to revise and extend his re-
marks.)

Mr. UDALL. Mr. Speaker, one of the
most troublesome problems which has
confronted recent Congresses is the ques-
tion of devising sound school-aid legisla-
tion. This search has been intensified by
the challenge, implicit in the sputniks,
that the race for intellectual supremacy
may be the decisive arena in our conflict
with the Communist world.

To date major Federal aid to educa-
tion bills have failed to win majority sup-
port largely for the reason that particu-
lar features of each bill have aroused
widespread opposition. For example,
fear of Federal control of education has
been a dominant stumbling block for
many of our colleagues. Others have
pointed a critical finger at the bureau-
cratic pyramiding involved in most pro-
posals and its attendant expense; and
still others have objected to various bills
on the ground that they were not ad-
dressed to the total problem of education.

Today I have introduced a bill which,
I believe, will meet the real needs of edu-
cation, and simultaneously satisfy these
objections. This legislation is simplicity

CONGRESSIONAL RECORD — HOUSE

itself; it has no Federal controls what-
soever; not a single additional Federal
employee need be hired to supervise its
operation; it will provide for an even-
handed distribution of Federal funds;
and lastly it will permit each State to
further its major educational objectives
by distributing these funds through ex-
isting State aid pipelines.

More important, it puts to use the ma-
chinery and experience of our oldest
Federal aid to education—the 68-year-
old grant college assistance program.

In addition, it embodies the merits
contained in the Scrivner amendment,
and rejects the bad features of that pro-
Posal.

Likewise it embraces the soundest ap-
plicable provisions of the Kelley bill,
without incorporating elements in that
proposal which were unacceptable to
many members.

Following the guidelines laid down by
the second Morrill Act of 1890, as amend-
ed, this legislation would function as
follows:

First. Funds would be appropriated
anually by Congress—as a starting point
I have suggested that the first year’s ap-
propriation should be $500 million.

Second. These funds would be allocated
to the States under a flat-grant formula
based on the school age population of
each State.

Third. Payments would be made di-
rectly to the States quarterly by the
Secretary of the Treasury under this
objective formula and without the inter-
vention of any Federal discretion.

Fourth. Each State would distribute
the funds to local school districts for
teachers’ salaries, school facilities, and
equipment in accordance with current
State-aid programs.

Fifth. Again following the pattern of
the land-grant college program, at the
close of every fiscal year each State edu-
cational agency would make a report to
the United States Commisioner of Edu-
cation on how the funds have been used.
In turn, these reports would be trans-
mitted to the Congress by the Commis-
sioner together with his recommenda-
tions.

There would be no Federal adminis-
trative control whatsoever of education
under this act. The States would ad-
minister the grants under the Federal
statute and the Congress itself would
evaluate the results with the assistance
of the Commissioner. I am informed
this system has worked flawlessly under
the Morrill Act.

Mr. Speaker, the local real property
tax base is no longer a reliable indicator
of income or ability to pay taxes. Nei-
ther is it adequate since in 1956 the
locally assessed valuation totalled only
$210 billion for all States combined. This
tax base is inadequate to bear most of
the annual school tax load of approxi-
mately $7 billion in addition to a major
share of the cost of other necessary local
public services, and is so unevenly dis-
tributed in every State that school dis-
tricts find adequate public-school financ-
ing increasingly difficult.

The States now supply nearly $5 bil-
lion annually to school districts from
State tax sources. In 1958, approxi-

6991
mately 50 percent of these State funds
are being distributed to local school
districts ‘under grants varied according
to need. Even so, the States have not
succeeded in providing enough funds to
finance adequate programs of education
in all districts. Additional State funds
are increasingly difficult to obtain, partly
because the financial incentives offered
by the Federal Government to State leg-
islatures through matching grants for
welfare, health, highways, and other
services give them priorities on State
appropriations. My proposal would tend
to provide some equity for education
without placing it in direct competition
with other public services through Fed-
eral matching funds.

The basic purpose is the overdue rec-
ognition of education as an extremely
important long-term determiner of the
national security. Our potential enemies
have said they can excel the United
States in world influence through supe-
rior education and without resort to
arms. The challenge is clear and real-
istic. It is unthinkable that the Na-
tional Government shall look the other
way while creating conditions by its own
actions which make impossible an edu-
cational system of the quality the na-
tional interest requires.

CHEMICALS IN OUR FOOD CAN
CAUSE CANCER

(Mr. DELANEY asked and was given
permission to address the House for 1
minute and to revise and extend his re-
marks.)

Mr. DELANEY. Mr. Speaker, for
many years I have been pressing for
the enactment of legislation to prohibit
the use of chemical additives in foods
unless adequate tests have first demon-
strated that they are safe for use.

A recent ruling proposed by the Food
and Drug Administration points up the
necessity for this legislation.

This is a ruling against a pesticide
called Aramite, which is known to in-
duce cancer in test animals.

For over 2 years, cancer experts have
been warning that this pesticide is not
safe for human consumption in any
amount.

Nevertheless, FDA has permitted its
use on apples, blueberries, cantaloups,
celery, cucumbers, grapefruit, grapes,
green beans, lemons, muskmelons,
oranges, peaches, pears, plums, rasp-
berries, strawberries, sweet corn, toma-
toes, and watermelons.

My food additive bill, H. R. 7798, in
addition to requiring the pretesting of
chemical additives to prove safety, would
specifically ban the introduction into
food of any cancer-inducing chemical.

There has been strong opposition to
this provision, but the Aramite story

shows why it is needed.
Back in February 1955, as required by
Public Law 83-518—the pesticide

amendment to the Federal Food, Drug,
and Cosmetic Act—the United States
Rubber Co. filed with FDA a petition
requesting the establishment of toler-
ances of 2 parts per million for residues
of Aramite, in or on certain fruits and
vegetables, and tolerances of 5 parts per

— *
1958
15th of this month, prior to the new
FDA ruling, I stated:

The precedent established by the Aramite
decision has opened the door, even if only
a little, to the use of carcinogens in our

foods. That door should be slammed shut
and locked.

It is my firm purpose to do just that.

Surely there is nothing of greater im-
portance to any nation than the health
of its people.

We have a serious responsibility in
this field. It is urgent that we meet it
as soon as possible, and as completely as
possible.

AMENDMENT OF SOCIAL
SECURITY ACT

(Mr. CURTIS of Missouri, at the re-
quest of Mr. Treacue of California, was
given permission to extend his remarks
at this point in the Recorp.)

Title X has been in effect since 1935.
Since 1950, all 48 States have had plans
which qualify for Federal reimburse-
ment. Prior to 1950, however, Missouri
and Pennsylvania had in effect laid
plans for the blind which had failed to
conform to the Federal interpretation of
the so-called needs test amendment of
1939. That amendment provided: “A
State agency shall, in determining need,
take into consideration any other in-
come and resources of an individual
claiming aid to the blind”—section 1002
(a) (8). From 1937 to 1950 the blind
people of Missouri and Pennsylvania and
their State legislatures consistently re-
fused to accept Federal matching funds
if it meant scrapping their more liberal
State blind pension and enacting in lieu
thereof a more restrictive law which
would conform to Federal requirements.

No. 68——14

CONGRESSIONAL RECORD — HOUSE

In the case of any State * * * which did
not have on January 1, 1949, a State plan
for aid to the blind approved under title
x, * * * the Administrator shall approve
a plan of such State for aid to the blind for
the purposes of this title X, even though it
does not meet the requirements of clause
(8) of subsection (a), if it meets all other
requirements of title X for an approved
plan for aid to the blind; but payments
under section 1003 shall be made, in the
case of any such plan, only with respect to
expenditures thereunder which would be
included as expenditures for the purposes
of section 1003 under a plan approved under
title X without regard to the provisions of
this section.

The amendment to the Social Secu-
rity Act was originally enacted to termi-
nate on June 30, 1955. Its life has
since been twice extended, first to June
30, 1957, and now to June 30, 1959. The
bill which I have just introduced pro-
poses a solution that will put to rest,
once and for all, the issues presented by
the Missouri and Pennsylvania plans,
Accordingly, this bill is proposed to take
effect on July 1, 1959.

The Missouri and Pennsylvania pro-
grams are primarily more liberal than
Federal requirements in the following
regards:

Second. In Missouri and Pennsyl-
vania a flat fixed amount of $60 is paid
to each recipient each month. This is
in contrast to the variable individual
payments of the Federal law.

Fourth. In Missouri and Pennsyl-
vania the amount of cash and property
that a blind person may have and still
qualify for the full pension is more lib-
eral than under the Federal provisions.

A study of the Missouri and Pennsyl-
vania plans discloses, I think, quite well
how far these two States have gone in
their efforts to encourage the rehabilita-
tion of its nonsighted citizens. They
have enlarged their economic opportu-
nities to the end that they may render
themselves independent of public as-
sistance and become entirely self-sup-

6993

porting. These programs have proved
highly successful and have paved the
way for more enlightened socio-econom-
ie legislation in the other 46 States. I
have long been impressed with the wis-
dom of the words of Justice Brandeis
who said “it is one of the happy in-
cidents of the Federal system that a
single courageous State may, if its cit-
izens choose, serve as a laboratory; and
try novel and economic experiments
without risk to the rest of the country.”
The value of this thesis is demonstrated
by the Missouri and Pennsylvania plans.
Our aid to the blind program should be
directed to the ends of rehabilitation
and helping our nonsighted people to
become useful and productive citizens.
The above described needs test tends to
hurt our efforts at rehabilitation. Its
effect is to destroy initiative and desire
to make the most of the blind’s produc-
tive years. The bill which I have in-
troduced today is intended to preserve
the minimum standards of clause (8)
but it still allows the States to develop
their programs in accordance with mod-
ern thinking and to encourage more lib-
eral provisions provided that the States
are willing to finance their expanded
programs out of State funds.

This bill, then, would resolve the fol-
lowing Federal-State issues which have
been raised by the present title X of the
Social Security Act, to wit:

First. It would preserve to the States
their right to provide improved social-
welfare programs for the blind wholly
financed out of State funds.

Fourth. No limitation or requirement
on the allowable exceptions from the
means test in the direction of greater
liberality would be imposed upon any
State plan in order to retain a title X
Federal grant for federally eligible cases.
In order to prevent the States from cir-
cumventing the minimum standards of
the Federal program by transferring
recipients to a drastically less adequate
State program, the States are permitted
to increase, but not decrease the extent
to which the recipients’ earnings, or in-
come, or other resources will be accepted
from the means test. :

6994

Congress in 1956 proclaimed self-care

and self-support to be one of the pur-

poses of the public assistance provisions
of the Social Security Act.

Sixth. This bill, if enacted into law,
would simply restore an important
States right—the right to provide at
State expense, a more liberal program of
aid to the blind than the Federal Gov-
ernment chooses to allow. Since under
the provisions of this legislation, the
Federal Government would only provide
participating funds for those individuals
who would qualify under the present
strict Federal definition of need, the plan
could not possibly increase the cost to
the Federal Government. It would in
fact in time provide a real financial
benefit to the Federal Government.
Through more liberal State financed
welfare programs geared to rehabilita-
‘tion and self-support, more blind people
will make their way off of the relief rolls
and will encourage our nonsighted citi-
zens to make the most of their produc-
tive years, and by so doing, to become
more useful citizens.

The text of the bill is as follows:

A bill to amend title X of the Social Secu-
rity Act to provide that, without an in-
crease of Federal participating funds, a
State plan for aid to the blind may utilize
a more liberal needs test than that pres-
ently specified in such title
Be it enacted, etc., That (a) clause (8) of

section 1002 (a) of the Social Security Act

is amended by inserting after “provide” the
following: “(unless this clause is inappli-

» cable by reason of the last sentence of this

subsection) .”" 2

(b) Section 1002 (a) of such act is further
amended by adding at the end thereof the
following new sentence: “A State plan for
‘aid to the blind shall not be required to
meet the requirements of clause (8) if in
lieu thereof it provides that the State agency,
in determining need, shall take into consid-
eration less of the other income and re-
sources of the individual claiming aid to the
blind than would be required to be consid-
ered under claus (8) or shall disregard more
than the first $50 per month of earned in-
come, or that the State agency shall pay a
fixed sum to all individuals eligible for aid
to the blind; but payments under section
1003 shall be made, in the case of any such
plan, only with respect to expenditures
thereunder which would be included as ex-
penditures for the purposes of section 1003 if
the plan met the requirements of clause (8).”

Sec. 2. (a) The amendments made by this
act shall be effective on and after July 1,
1959.

(b) Effective July 1, 1959, section 344 of
the Soical Security Act Amendments of 1950
is repealed.

NATIONAL RADIO MONTH AND THE
FIRST AMENDMENT

(Mr. McCORMACK asked and was
given permission to address the House
for 10 minutes and to revise and extend
his remarks.)

Mr. McCORMACK. Mr. Speaker, ra-
dio was undreamed of when this coun-
try was founded. Yet today it holds
major meaning and may be said to be
the very breath of life in the first

‘government these combined

CONGRESSIONAL RECORD — HOUSE

amendment to the Constitution of the
United States. When the Constitution
enjoins the Congress from making any
law abridging the freedom of speech it
extends the infinite blessings of this
prohibition by the very nature of things
to the electronic miracles of communi-
cation, Without electronic communica-
tion, as we live today, it is almost im-
possible to think either of the demo-
cratic process or modern civilization in
the free world.

It is for these reasons that I attach
such great importance to National
Radio Month during May. I say “great
importance” because the dignity of man
is interwoven profoundly in the rela-
tionship of a people and their Govern-
ment. Government—Federal, State, lo-
cal—has been brought into such inti-
mate contact with the people that the
thongs of freedom, of government by
consent, and government by participa-
tion of the citizen in the decisions of
government, have been strengthened as
much by radio,-as formerly they were
strengthened -by the invention of the
printing press.

Radio stands out as a phenomenon
unparalleled in its time, unless it is by
TV, in the acceleration of modern in-
dustrial progress. All mankind bene-
fited from an enlightened conspiracy
among science, invention, capitalism,
and free enterprise. Under democratic
in the
United States to bring the impact of
this instrument we call radio to such
fruition that in a matter of a few dec-
ades hardly an ear among 172 millions
of Americans is not—at the turn of a
dial—within hearing of some broadcast-
ing station, some network, some sound
carrying with it news or entertainment,
information or instruction, edification
or the advertising that helps to keep
our economy dynamic.

A self-governed people can never in
the future say that inadequate communi-
cation was responsible for any of its ills.

Of course in the diversity of projects
so all-enveloping as radio there are
flaws. The burden now is upon those
who manage and manipulate communi-
cations. It is in this connection that
I would like to take this opportunity to
congratulate the radio industry proper
and the National Association of Broad-
easters for a job that is on the whole
commendable. I know they join me in
the hope of even greater improvement
in the future. The slow but constantly
advancing character of betterment in
their management indicates their aware-
ness of the problems involved in the
monumental responsibility that falls
upon them with compelling directness.

tee
April 30
most 90 percent of the total adult popu-

lation of our country. Radio, let me
add, is no replacement and no substitute
for the home newspaper, but it is cer-
tainly a remarkable complement to
printed journalism, and an enormous
source of public information in its own
right.

In the face of this revolutionary
change in communication we have to re-
fiect that the idea of the transmission
and reception of signals by means of
electric waves without a connecting wire
was once called radiotelegraphy or
radiotelephony and in its current state
of development is quite within the
memory of contemporary man. Its
theoretical origins go back to 1864, and
then to 1887, bringing up such names
respectively as Clerk-Maxwell and Prof.
H. Hertz. Later with further discov-
eries came Edouard Branly and Sir
Oliver Lodge. Finally Guglielmo Mar-
coni in 1895 applied these theories prac-
tically until in 1901 he signaled the
letter “S” across the Atlantic.

The following year—1902—the world
heard the first transatlantic message by
wireless.

Then came the electron tube in con-
nection with which such names are
notable as that of Fleming, DeForest,
and Langmuir. Radio moved out of the
mind of man into the laboratory. It
then drove with positively massive re-
sults into the factory providing a vast
new source of wealth altogether apart
from its services as an instrument of
communication to the whole of mankind.
The radio industry today has jumped
from the production of 12 million re-
ceiving sets in 1940 to 55 million in 1951,
according to 1 research organization,
and 53 million in 1957. If we unite radio
manufacture with radio broadcasting
we have, of course, an American industry
of the first magnitude, and industry that
only began to exist after World War I.
When I speak of the acceleration of in-
dustry under capitalism and free enter-
prise_and democratic government this
is what I mean.

Research that I had instituted for this
statement reveals a wealth of further
data that is, on the whole, illustrative of
superior management by private indus-
try and, with the usual exceptions, en-
lightened regulation by Government.
All this was achieved without enslaving
our scientists, without bribing them,
without segregating them, and without
intimidating them. They and the in-
dustrialists and financiers and entrepe-
neurs who followed them, and the tens of
thousands of employees in the field, made
their enormous cumulative contribution
to civilization and the democratic proc-
ess as free men and women. We do not
claim radio as a totally American idea as
I have shown.. The genius of man from
varied backgrounds and cultures, under
our flag and under other flags, gave us
this great gift. But I like to think that
under free government here or in West-
ern Europe or anywhere the genius of
man gets its freest play for the good of
all. I like to think that this is done
under a policy that does not push science
and does not subject it to the indignity
of either compulsion or of sudden flat-

1958

his leadership in matters pertaining to

Illinois transcends party lines. It is not
unusual for the entire Illinois groups,
Democrats and Republicans, to assemble
in Tom’s office for guidance on impor-
tant legislation which means so much to
the development of the Chicago area and
to the welfare of the people of Illinois.

SOUND SCHOOL-AID LEGISLATION

(Mr. UDALL asked and was given per-
mission to address the House for 1 min-
ute and to revise and extend his re-
marks.)

Today I have introduced a bill which,
I believe, will meet the real needs of edu-
cation, and simultaneously satisfy these
objections. This legislation is simplicity

CONGRESSIONAL RECORD — HOUSE

More important, it puts to use the ma-
chinery and experience of our oldest
Federal aid to education—the 68-year-
old grant college assistance program.

In addition, it embodies the merits
contained in the Scrivner amendment,
and rejects the bad features of that pro-
posal.

Likewise it embraces the soundest ap-
plicable provisions of the Kelley bill,
without incorporating elements in that
proposal which were unacceptable to
many members.

Following the guidelines laid down by
the second Morrill Act of 1890, as amend-
ed, this legislation would function as
follows:

First. Funds would be appropriated
anually by Congress—as a starting point
I have suggested that the first-year’s ap-
propriation should be $500 million.

Second. These funds would be allocated
to the States under a flat-grant formula
based on the school age population of
each State.

Third, Payments would be made di-
rectly to the States quarterly by the
Secretary of the Treasury under this
objective formula and without the inter-
vention of any Federal discretion.

Fourth. Each State would distribute
the funds to local school districts for
teachers’ salaries, school facilities, and
equipment in accordance with current
State-aid programs, ~

The States now supply nearly $5 bil-
lion annually to school districts from
State tax sources, In 1958, approxi-

6991

mately 50 percent of these State funds
are being distributed to local school
districts under grants varied according
to need. Even so, the States have not
succeeded in providing enough funds to
finance adequate programs of education
in all districts. Additional State funds
are increasingly difficult to obtain, partly
because the financial incentives offered
by the Federal Government to State leg-
islatures through matching grants for
welfare, health, highways, and other
services give them priorities on State
appropriations. My proposal would tend
to provide some equity for education
without placing it in direct competition
with other public services through Fed-
eral matching funds.

CHEMICALS IN OUR FOOD CAN
CAUSE CANCER

(Mr. DELANEY asked and was given
permission to address the House for 1
minute and to revise and extend his re-
marks.)

A recent ruling proposed by the Food
and Drug Administration points up the
necessity for this legislation.

This is a ruling against a pesticide
called Aramite, which is known to in-
duce cancer in test animals.

For over 2 years, cancer experts have
been warning that this pesticide is not
safe for human consumption in any
amount.

My food additive bill, H. R. 7798, in
addition to requiring the pretesting of
chemical additives to prove safety, would
specifically ban the introduction into
food of any cancer-inducing chemical.

There has been strong opposition to
this provision, but the Aramite story
shows why it is needed.

Back in February 1955, as required by
Public Law 83-518—the pesticide
amendment to the Federal Food, Drug,
and Cosmetic Act—the United States
Rubber Co. filed with FDA a petition
requesting the establishment of toler-
ances of 2 parts per million for residues
of Aramite, in or on certain fruits and
vegetables, and tolerances of 5 parts per

6992

million on certain other raw agricultural
commodities.

This committee met in Washington on
July 27, 1955, and following a morning
and an afternoon session, issued three
recommendations:

1. That a residue tolerance of 1 part per

million be established for aramite under the
provisions of Public Law 518, 83d Congress.

However, the committee apparently
was not convinced that aramite was
harmless, because it also recommended:

2. That the petitioner be advised to secure
acceptable data on the chronic toxicity and
carcinogenicity of aramite at feeding levels
between zero and 500 parts per million in the
mouse, rat, and dog.

3. That-the entire problem be reviewed by
this or another committee in 1957, when fur-
ther laboratory and other data are available.

These, surely, were strange recom-
mendations for scientists to make. They
admitted that they felt that the data
which they reviewed were insufficient
and incomplete, and, in particular, sug-
gested that more information be secured
regarding the cancer inducing propen-
sities of aramite. Yet, at the same time,
they were perfectly willing that the pub-
lic be exposed to a certain amount of it.

Here, it seems to me, is a perfect ex-
ample of the apparent willingness of
government to accommodate big busi-
ness and let the public take the risk.

At the time of its original ruling, the
Food and Drug Administration had on
hand evidence to show that aramite, so
. far as the public health was concerned,
was at least a suspicious product. Under
the law, FDA was not required to accept
the recommendations of the advisory

CONGRESSIONAL RECORD — HOUSE

committee and grant any tolerance of
the chemical.

I first brought this to the attention of
the Congress on February 21, 1957, when
I placed in the CONGRESSIONAL RECORD a
letter written to me by a noted cancer
researcher, Dr. William E. Smith.

Dr. Smith has had a brilliant research
career and at various times has been
on the staffs of the Harvard Medical

chool, the Rockefeller Institute for
Medical Research, the Sloan-Kettering
Institute for Cancer Research, and was
at one time an associate professor of in-
dustrial medicine at New York Univer-
sity. At present, he is doing research at
the Fairleigh Dickinson University and
is secretary of the Cancer Prevention
Committee. Dr. Smith is a dedicated
scientist, and a courageous man who has
not hesitated to tangle with the indus-
tries in attacking practices which he has
felt might endanger the public health.

Here I should like to pause a moment
to express my appreciation for the strong
support that our much admired col-
league from St. Louis has given in this
food additive issue. She has spoken
eloquently on the floor of the House on
this subject, has given radio talks, has
conferred with women’s groups and con-
sumer organizations. Her interest and
concern have been a most valuable con-
tribution. =

The carcinogen provision, which I
have anentioned, follows the unanimous
recommendation of the International
Union Against Cancer at its symposium
in Rome in August 1956. This sym-
posium was attended by over 40 cancer
experts from some 20 countries,

The recommendation stated:

The conference recommends that, as a
basis for active cancer prevention, the proper
authorities of various countries promulgate
and enact adequate rules and regulations
prohibiting the addition to food of sub-
stances having potential carcinogenicity.

The two following recommendations
were also unanimously approved:

1. Food additives should be permitted
only if, after long-term administration to
at least two species of animals (one prefer-
ably a nonrodent), orally and parenterally, in
amounts which must be considerably higher
than would be present in food, and, after
observation of the animals over their life-

xy
April 30

time, and through at least two generations
in at least one suitable species, they have
no toxic effect.

H.R. 7798 not only follows the recom-
mendations of the International Union
Against Cancer but also conforms with
recommendations of the American Can-
cer Society.

A letter sent to the Subcommittee on
Health and Science on July 22, 1957, by
Mr. James S. Adams, chairman of the
legislative committee of the American
Cancer Society, states as follows:

We strongly urge that your committee rec-
ommend legislation to the Congress to
strengthen the Food and Drug Administra-

tion and that this legislation embrace the
following principles:

2. That permission to use the additive be
withheld until its safety has been demon-
strated to the satisfaction of the Food and
Drug Administration by the proponent.

3. That no substance shall be approved
found to induce cancer in man, or after tests
provided in No. 1 above, found to induce
cancer in animals.

Mr. Speaker, it is appalling to think
that 1 out of every 4 persons in this
country will at some time or another
suffer from cancer. While we may not

yet completely understand the part that
chemical additives play in the cancer
picture, enough is known to put us on
our guard.

In my last appearance before the
Health and Science Subcommittee on the

a
* 1958

15th of this month, prior to the new
FDA ruling, I stated:

The precedent established by the Aramite
decision has opened the door, even if only
a little, to the use of carcinogens in our
foods, That door should be slammed shut
and locked.

It is my firm purpose to do just that.

Surely there is nothing of greater im-
portance to any nation than the health
of its people.

We have a serious responsibility in
this field. It is urgent that we meet it
as soon as possible, and as completely as
possible.

AMENDMENT OF SOCIAL
SECURITY ACT

(Mr. CURTIS of Missouri, at the re-
quest of Mr. Teacue of California, was
given permission to extend his remarks
at this point in the Rrcorp.) :

Title X has been in effect since 1935.
Since 1950, all 48 States have had plans
which qualify for Federal reimburse-
ment. Prior to 1950, however, Missouri
and Pennsylvania had in effect laid
plans for the blind which had failed to
conform to the Federal interpretation of
the so-called needs test amendment of
1939. That amendment provided: “A
State agency shall, in determining need,
take into consideration any other in-
come and resources of an individual
claiming aid to the blind”—section 1002
(a) (8). From 1937 to 1950 the blind
people of Missouri and Pennsylvania and
their State legislatures consistently re-
fused to accept Federal matching funds
if it meant scrapping their more liberal
State blind pension and enacting in lieu
thereof a more restrictive law which

~ would conform to Federal requirements.

No. 68——14

CONGRESSIONAL RECORD — HOUSE

In the case of any State * * * which did
not have on January 1, 1949, a State-plan
for aid to the blind approved under title
x, * * * the Administrator shall approve

& plan of such State for aid to the blind for

the purposes of this title X, even though it
does not meet the requirements of clause
(8) of subsection (a), if it meets all other
requirements of title “X for an approved
plan for aid to the blind; but payments
under section 1003 shall be made, in the
case of any such plan, only with respect to
expenditures thereunder which would be
included as expenditures for the purposes
of section 1003 under a plan approved under
title X without regard to the provisions of
this section.

The Missouri and Pennsylvania pro-
grams are primarily more liberal than
Federal requirements in the following
regards:

Second. In Missouri and Pennsyl-
vania a flat fixed amount of $60 is paid
to each recipient each month. This is
in contrast to the variable individual
payments of the Federal law.

Fourth. In Missouri and Pennsyl-
vania the amount of cash and property
that a blind person may have and still
qualify for the full pension is more lib-
eral than under the Federal provisions.

6993

porting. These programs have proved
highly successful and have paved the
way for more enlightened socio-econom-
ic legislation in the other 46 States. I
have long been impressed with the wis-
dom of the words of Justice Brandeis
who said “it is one of the happy in-
cidents of the Federal system that a
single courageous State may, if its cit-
izens choose, serve as a laboratory; and
try novel and economic experiments
without risk to the rest of the country.”
The value of this thesis is demonstrated
by the Missouri and Pennsylvania plans.
Our aid to the blind program should be
directed to the ends of rehabilitation
and helping our nonsighted people to
become useful and productive citizens.
The above described needs test tends to
hurt our efforts at rehabilitation. Its
effect is to destroy initiative and desire
to make the most of the blind’s produc-
tive years. The bill which I have in-
troduced today is intended to preserve
the minimum standards of clause (8)
but it still allows the States to develop
their programs in accordance with mod-
ern thinking and to encourage more lib-
eral provisions provided that the States
are willing to finance their expanded
programs out of State funds.

This bill, then, would resolve the fol-
lowing Federal-State issues which have
been raised by the present title X of the
Social Security Act, to wit:

First. It would preserve to the States
their right to provide improved social-
welfare programs for the blind wholly
financed out of State funds.

Third. The amount of each State’s
Federal grant would continue to be meas.
ured by the present standards and on
like terms to all States. The definition
of the means test that is contained in
clause (8) of section 1002 (a) would ap-
ply to all States for the purpose of deter-
mining the part of any State’s expendi-
tures that will be covered by the Federal
grant.

6994

Congress in 1956 proclaimed self-care

and self-support to be one of the pur-

poses of the public assistance provisions
of the Social Security Act.

Sixth. This bill, if enacted into law,
would simply restore an important
States right—the right to provide at
State expense, a more liberal program of
aid to the blind than the Federal Gov-
ernment chooses to allow. Since under
the provisions of this legislation, the
Federal Government would only provide
participating funds for those individuals
who would qualify under the present
strict Federal definition of need, the plan
could not possibly increase the cost to
the Federal Government.» It would in
fact in time provide a real financial
benefit to the Federal Government.
Through more liberal State financed
welfare programs geared to rehabilita-
tion and self-support, more blind people
will make their way off of the relief rolls
and will encourage our nonsighted citi-
zens to make the most of their produc-
tive years, and by so doing, to become
more useful citizens.

The text of the bill is as follows:

A bill to amend title X of the Social Secu-
rity Act to provide that, without an in-
crease of Federal participating funds, a
State plan for aid to the blind may utilize
@ more liberal needs test than that pres-
ently specified in such title
Be it enacted, etc., That (a) clause (8) of

section 1002 (a) of the Social Security Act
is amended by inserting after ‘tprovide” the
following: “(unless this clause is inappli-
cable by reason of the last sentence of this
subsection) .”

(b) Section 1002 (a) of such act is further
amended by adding at the end thereof the
following new sentence: “A State plan for
aid to the blind shall not be required to
meet the requirements of clause (8) if in
lieu thereof it provides that the State agency,
in determining need, shall take into consid-
eration less of the other income and re-
sources of the individual claiming aid to the
blind than would be required to be consid-
ered under claus (8) or shall*disregard more
than the first $50 per month of earned in-
come, or that the State agency shall pay a
fixed sum to all individuals eligible for aid
to the blind; but payments under section
1003 shall be made, in the case of any such
plan, only with respect to expenditures
thereunder which would be included as ex-
penditures for the purposes of section 1003 if
the plan met the requirements of clause (8) .”

Src. 2. (a) The amendments made by this
act shall be effective on and after July 1,
1959.

(b) Effective July 1, 1959, section 344 of
the Soical Security Act Amendments of 1950
is repealed.

NATIONAL RADIO MONTH AND THE
FIRST AMENDMENT

(Mr. McCORMACK asked and was
given permission to address the House
for 10 minutes and to revise and extend
his remarks.)

Mr. McCORMACK. Mr. Speaker, ra-
dio was undreamed of when this coun-
try was founded. Yet today it holds
major meaning and may be said to be
the very breath of life in the first

CONGRESSIONAL RECORD — HOUSE

Radio stands out as a phenomenon
unparalleled in its time, unless it is by
TV, in the acceleration of modern in-
dustrial progress. All mankind bene-
fited from an enlightened conspiracy
among science, invention, capitalism,
and free enterprise. Under democratic
government these combined in the
United States to bring the impact of
this instrument we call radio to such
fruition that in a matter of a few dec-
ades hardly an ear among 172 millions
of Americans is_not—at the turn of a
dial—within hearing of some broadcast-
ing station, some network, some sound
carrying with it news or entertainment,
information or instruction, edification
or the advertising that helps to keep
our economy dynamic.

A self-governed people can never in
the future say that inadequate communi-
cation was responsible for any of its ills.

~
April 30

most 90 percent of the total adult popu-

In the face of this revolutionary
change in communication we have to re-
flect that the idea of the transmission
and reception of signals by means of
electric waves without a connecting wire
was once called radiotelegraphy or
radiotelephony and in its current state
of development is quite within the
memory of contemporary man. Its
theoretical origins go back to 1864, and
then to 1887, bringing up such names
respectively as Clerk-Maxwell and Prof,
H. Hertz. Later with further discov-
eries came Edouard Branly and Sir
Oliver Lodge. Finally Guglielmo Mar-
coni in 1895 applied these theories prac-
tically until in 1901 he ‘signaled the
letter “S” across the Atlantic.

The following year—1902—the world
heard the first transatlantic message by
wireless.

Research that I had instituted for this
statement reveals a wealth of further
data that is, on the whole, illustrative of
superior management by private indus-
try and, with the usual exceptions, en-
lightened regulation by Government.
All this was achieved without enslaving
our scientists, without bribing them,
without segregating them, and without
intimidating them. They and the in-
dustrialists and financiers and entrepe-
neurs who followed them, and the tens of
thousands of employees in the field, made
their enormous cumulative contribution
to civilization and the democratic proc-
ess as free men and women. We do not
claim radio as a totally American idea as
Ihave shown. The genius of man from
varied backgrounds and cultures, under
our flag and under other flags, gave us
this great gift. But I like to think that
under free government here or in West-
ern Europe or anywhere the genius of
man gets its freest play for the good of
all. I like to think that this is done
under a policy that does not push science
and does not subject it to the indignity
of either compulsion or of sudden flat-

DRAKA OLATBEMGn i UN BAURG NUL Ur Uiueiut a UPLAN a

During the 8lst Congress, in 1949, a Select Committee to Investigate the

Use of Chemicals in Foods and Cosmetics - better known as the Delaney
Committee,named after its chairman, Congressman James J. Delaney - was
created in the House of Representatives to study the need to amend the
present Food, Drug,and Cosmetic Act in this respect. After extended hearings,
the committee on June 30, 1952, filed a report urging the amendment of this
law so that xha chemicals employed in or on foods would be subjected to

the same safety requirements as existed in the law for new drugs.

(Bills to accomplish the objectives of the report were introduced

during the 83rd and subsequent Congresses by Congressman Delaney and referred
to the Committee on Interstate and Foreign Commerce. Finally, during

the 85th Congress, a bill was reported out of the committee - H.R. 13254,-
the Food Additives Amendment of 1958 = to the floor. An amendment was
suggested to this bill by Mr. Delaney (Section 409 (c) (3) (A) ) to

read: | |

t
Provided,that no additive shall be deemed safe if it is found

to induce cancer when ingested by man or animal, or if it is
found, after tests which are appoopriate for the evaluation of
the safety of food additives, to induce cancer in man or animal.

The bill - H.R. 13254 - with the Delaney Amendment passed the House of
Representatives of August 13, 1958, and was signed into law on Spptember 6

of that year.

1 RR NE Rn ante me mR RAE NO NER FSO EF YS et tee et A ER ANG My erat Ate AN fe Ye I Le Ff LR NN RHE RS woe Se

In the 87th Congress, the Drug Industry Act of 1962 added the following

amendment aftdr the Delaney clause:

except that this provisé shall not apply with respect to

the use of a substance as an ingredient of feed for animals
which are raised for food production, if the Secretary finds
(1) that, under the conditions of use and feeding specified

in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animal
for which such feed is intendedm and that no residue of the
additive will be found (by methods of examination prescribed
or approved by the Secretary by regulations, which regulations
shall not be subject to subsections (f) and (g) of this section)
in any edible portion of such animal after slaughter or in

any food yielded by or derived from the living animal;

Although repeated attempts have been made over a period of years to mtee
or to eliminate the Delaney clause , it still remains on the books

as one of the safeguards of consumer health. To quote a recent rebuttal
offered to those who would "nibble away" at the rigid strictures of the
clause: "Moreover, there is clear evidence that to establish 'safe
tolerances' would constitute a giant backward step in pubic. protection-

offered in the name of science."

Title 21 Sec. 348 (c) (3)

After Delaney clause the following amendment was added by the Drug
Industry Act of 1962: "except that this proviso shall not apply with
respect to the use of a substance as an ingredient of feed for animals
which are raised for food production, if the Secretary finds (i) that,
under the conditions of use and feeding specified in proposed labeling
and reasonably certain to be followed in practice, such additive will not
adversely affect the animal for which such feed in intended, and

(88) that no residue of the additive will be found &x (by methods of
examination prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g) of this
section) in any edible portion of such animal after slaughter or in any
food yielded by or derived from the living animal;

a a ee).

é
A PROPOSAL FOR REVISION OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT
(21USC 321 et seq) SO AS TO EXEMPT FROM THE "DELANEY CLAUSE" (21USC348
(c)(3)) OF THE FOOD ADDITIVES AMENDMENT SUBSTANCES INTENDED FOR FEEDING
ONLY TO ANIMALS WHEN NO RESIDUES THEREOF WILL RESULT IN HUMAN FOOD

The Proposal

There is attached hereto as Appendix A a draft of a proposed
revision to the "Delaney Clause” to exempt therefrom substances intended
for feeding only to animals when it is show that, under the conditions
of intended use, no residue of such substance is found in edible tissues
or products of such animals.

The Need for Such a Revision

The need for this revision arises as a result of the interplay
between the Delaney Clause and the exemptions from the definition of the
term "food additive” contained in 21USC321 (a), as those oe _
been interpreted by the federal Food and Drug-Administration (FDA) t
apply to animal feeds containing either diethylstilbestrol (DES) or _
of the organic arsenicals.

The effect of this interplay, as interpreted by FDA, has led
to the following two highly inequitable results:

(1) No newly developed drug can be incorporated in any feed
containing DES or an organic arsenical, although numerous drugs cleared
by FDA prior to September 6, 1958 can continue to be used in those feeds.

(2) e feed manufacturers who had obtained an effective
new tia application (NDA) for an animal feed or feeds containing DES or

any "new drug” arsenical, prior to enactment of the Food Additives Amendment
on September 6, 1958, can continue to market such feed or feeds. On the other
hand, those feed manufacturers who had not obtained effective NDA's for such
a feed or feeds cannot market any feed containing DES or those arsenicals!

The magnitude of the inequity brought about by these two results
comes into sharp focus when you consider that about 70% of the manufactured
cattle feeds currently available contain DES, and about 70- -80% of manufac-
tured broiler feeds, and a high percentage of swine feeds, contain organic
arsenicals!

In view of the established commercial position of DES and the
arsenicals, and their relatively low cost, it is unlikely that the high
percentage of feeds in which they are used will be reduced for a consider-

able time yet to come.

The practical effect of result (1) above is to reduce the
potential market for newly developed drugs for feed use, for the for-
seeable future, to about 30% of the total market. When this fact is
considered in the light of the cost of research and development of such
drugs, and of obtaining the data to obtain clearance by FDA, it becomes
apparent why many drug manufacturers have substantially curtailed research
for such drugs.

The practical effect of result (2) above is that those feed
manufacturers who obtained NDA's for feeds containing DES or the "new
drug" arsenicals prior to enactment of the Food Additives Amendment are
assured of a virtual monopoly in the marketing of manufactured feeds as
against all those manufacturers who did not receive such prior FDA clear-
ance.

How This “Interplay” Brings About Such
Inequitable Results

In order for a substance which is added to food to be subject to
the Delaney clause, it mst, of course, be a "food additive." There are,
however, in Section 201(s) of the Act (21USC321(s)) certain so called
"exemptions" from the definition of the term "food additive", the most im-
portant of which are for:

(a) substances generally recognized as safe among experts
qualified by scientific training and experience to
evaluate safety (called the "generally recognized as
safe" exemption), and

(b) substances used in accordance with a sanction or
approval granted, prior to enactment of the Food
Additives Amendment, pursuant to certain statutes,
including the Food, Drug and Cosmetic Act (called
the "prior sanction” exemption).

Numerous feed manufacturers received effective NDA's for feeds
containing DES, alone and in combination with a number of the older drugs,
and for the organic arsenitals, alone and in combination with a number of
the older drugs, prior to enactment of the Food Additives Amendment.

Since enactment of that Amendment, however, FDA has been refus-
ing, on the basis of the Delaney clause, to make effective any NDA's for
feeds containing DES or the arsenicals, and has been refusing to amend
existing NDA's for such feeds to allow new drugs to be added. The reason
for these refusals is that DES has been found to imiuce cancer in some
laboratory animals, and it is suspected by some scientists that the organic
arsenicals may also induce cancer in some animals.

FDA takes the position that the "prior sanction" exemption
obtained as a result of the NDA's which were made effective prior to
the Amendment is "personal", and not an exemption for the drug or drugs
involved. In other words, FDA takes the view that the holders of those
NDA's have "prior sanction" exemptions for the feeds covered by those
NDA's and may continue to market them, whereas any feed manufacturer
who does not have such a "prior sanction” exemption is, in FDA's view,
barred by the Delaney clause from obtaining FDA clearance to market
exactly the same feed or feeds.

The ludicrous effect is that some feed manufacturers can mar-
ket feeds containing DES and such arsenicals as are new drugs, while
their competitors are precluded from marketing the very same feeds.

Moreover, FDA has ruled that these "prior sanction" exemptions
do not apply when any drug, other than one covered inthe original NDA,
is incorporated in those feeds. As a result of this ruling, FDA has,
on the basis of the Delaney clause, been refusing to clear any newly
developed drug for use in feeds containing DES or the "new drug” arseni-
cals.

In the case of those organic arsenicals used in feed which are
no longer new drugs, a further ludicrous situation has developed. FDA
has ruled that those arsenicals have a "generally recognized as safe™
exemption from the Amendment when used alone in feeds, or in combination
with some of the older drugs. FDA has also ruled, however, that when
any newly developed drug, no matter how safe it is, is added to such
feeds, the exemption no longer applies, and, moreover, that the Delaney
clause prohibits marketing such feeds!

An example will help to illustrate the commercial inequity which
results from this situation - Broiler feeds containing an arsenical and
penicillin can be marketed by anyone since such feeds have a "senerally
recognized as safe" exemption. It is not permitted, however, to substi-
tute for penicillin one of the newer antibiotics, even though the safety
of such substitute is firmly established! FDA would say the combination

of an arsenical with a newly developed antibiotic is barred by the Delaney
clause.

Explanation of the Revision to the Delaney
Clause Proposed In Appendix A

Fundamentally, the revision to the Delaney clause proposed in
Appendix A would authorize the Secretary of Health, Education and Welfare
to grant clearance for administration to animals only of a substance, such
as DES and the organic arsenicals, when it can be shown that, under the
conditions of intended use, such substance is safe for such animals, and
no residues of such substances will be found in edible tissues or products
of such animals "when tested by a method of assay having a level of sensi-

tivity satisfactory to the Secretary.

The words in quotes in the preceeding paragraph are included
in the proposal in recognition of the scientific fact that no assay
procedure can demonstrate absolute zero since each procedure is limited
by its level of sensitivity.

This proposed revision is in essence the one proposed last year
by former Secretary Flemming when he testified before the House Committee
on Interstate and Foreign Commerce during hearings on the Color Additives
bill (HR 7624). The statement, dated May 9th, 1960, which he submitted
to the Committee contained the following:

"kX we would oppose any change in the Delaney anticancer
clause of the Food Additives Amendment other than the

proposal I incorporated in my January 26th testimony.

At that time I stated that we believe the Delaney clause
should be modified to provide that additives used in
animal feed which leave no residue either in the animal
after slaughter or in any food product obtained from the
living animal be exempt from the provisions of the clause."

In the case of feeds containing DES, it seems fairly clear that
this proposed revision, if enacted, would obviate the two inequitable
results described earlier. The latest assay procedure which has been
developed for DES is sensitive to less than two parts per billion, which
should certainly be a level of sensitivity satisfactory to the Secretary.
Moreover, several times last year Secretary Flemming announced that the

public can purchase beef with assurance that it does not contain detectable
levels of DES.

Whether or not this proposed revision will obviate the present
inequitable situation concerning use of organic arsenicals in feeds, depends
upon whether absence of residues can be demonstrated by an assay procedure
having a level of sensitivity satisfactory to the Secretary. The fact that
arsenic is present natively in animal tissue is a complicating factor. It
is hoped that, if this proposed revision is enacted into law, the legislative
history will make it clear that the existence of background, levels of arsen-
ic in animal tissue should be taken into consideration by the Secretary in

making a determination as to whether the absence of residues of added arsenic
has been shown.

Appendix A

"(3) No such regulation shall issue if a fair evaluation of the data before
the Secretary -
"(A) Fails to establish that the proposed use of the food additive,

under the conditions of use to be specified in the regulation, will be safe:

Provided, that no additive shall be deemed to be safe;

(i) if it is found to induce cancer when ingested by man or
animal, or (ii) if it is found, after tests which are appropriate for the
evaluation of the safety of food additives, to induce cancer in man or animal;

unless such additive is intended for feeding to animals only, and it is shown
that, under the conditions of intended use:

(I) no residue of such additive is found in the edible

tissues or products of such animals when tested by a method of assay having a

level of sensitivity satisfactory to the Secretary; and

(II) such additive is safe for feeding to such animals;

ti]

(New Matter Underlined)

‘Title 21 Sec. 348 (c) (3)

After Delaney clause the following amendment was added by the Drug
Industry Act of 1962: “except that this proviso/shall not apply with
respect to the use of a substance as an ingredient of feed for animals
which are raised for food production, if the Secretary finds (i) that,
uader the conditions of use and feeding specified in proposed labeling
and reasonably certain to be followed in practice, such additive will not
adversely affect the animal for which such feed in intended, and

(88). that no residue of the additive will be found ix (by methods of
examination prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsectioaus (f) and (g) of this
section) in any. edible portion of such animal after slaughter or in any
food yielded by or derived from the living animal;

DEPARTMENT-OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MARYLAND 20852

JAN 31 1972

Honorable James J. Delaney
House of Representatives
Washington, D. C. 20515

Dear Mr. Delaney:

Commissioner Edwards has asked us to keep you informed of our
activities to assure the safety of food additives.

On June 25, 1971, FDA published a proposal in the Federal Register
to remove saccharin from the GRAS (Generally Recognized As Safe)
list and establish a provisional regulation prescribing conditions
of safe use. The review of the comments submitted to us on the
proposal has been completed, and we will shortly publish a final
order in the Federal Register. Enclosed is a copy of the order.

If you have any questions on this order or would like additional
copies, please let us know.

Sincerely yours,

M. J. Ryan, oS

Office of Legislative Services

Enclosure

PUBLIC HEALTH SERVICE

| iB = {| jt anes “a Wh :
“tu I. saad Vy | : FOOD AND DRUG ADMINISTRATION

me Vi Fe Rockville, Maryland 20852

Nistit John T., Walden (301) - 443-4177
Home phone: (301) 567-3148

72-7

FOR IMMEDIATE RELEASE:

Friday, January 28, 1972

The Food and Drug Administration today removed saccharin from
the GRAS (Generally Recognized As Safe) list of food additives and
issued an interim, provisional regulation restricting use of the
artificial sweetener while additional safety reviews are being
completed. Today's action made final a preliminary order issued
June 25, 1971, for public comment.

The interim order limits saccharin use in accord with a
National Academy of Sciences/National Research Council recommenda-
tion of no more than one gram per day for the average adult. One
gram of saccharin is equal to seven 12 be. howeias of the standard
diet drink. One gram of saccharin is equal to 60 of the small
saccharin tublets. Each tablet is a to one teaspoon of sugar.

The order requires saccharin disclosure on the labels of all
beverages, foods, and food mixes in which use is permitted.

Fos
In announcing publication of the new order, Charles Cc.

Edwards, M.D., Commissioner of Food and Drugs, emphasized that

the action is an interim step designed to "freeze" saccharin use

= Nore —

i a i ee
2s

at present levels pending final outcome of current research on

safety of the non-nutritive swectener.

Chronic feeding studies with saccharin in animals are being
conducted in FDA laboratories and by others. Preliminary reports
from one of these, Wisconsin Alumni Research Foundation, indicate
no injury when saccharin constitutes 0.05% of the daily diet -- a
level comparable to the one gram limit set by the FDA's regulatim.
At much higher levels, 5% of the daily diet, or approximately
| 100 times the maximum permitted by the new regulation, some test
animals developed bladder tumors. An intensive review is now under

way to determine whether or not these tumors are cancerous.

Saccharin has been widely used in the food supply for over 80
years without any evidence of human harm. The tentative adverse
findings in rats occurred at a level roughly ecutvalont in humans
6 875 bottles of a typical diet soft drink per day.

"The FDA, with the assistance of the NAS, will continue to
weigh the evidence ‘as it becomes available and should experimental
findings demonstrate that saccharin involves a risk to public

health, the FDA will withdraw approval for use of saccharin in

foods," said Commissioner Edwards.

ie
—

"In the meanwhile, the interim food additive order adequately
protects the public," he said.

Attached is a detailed status report on saccharin as well as
a copy of the FEDERAL REGISTER order announced today.

Attachments

STATUS REPORT - SACCHARILN

Current Activity

A. A two-year rat feeding study being conducted at the Wisconsin
Alunni Research Foundation (WARF) fae the Sugar Research Foundation
is nearing completion, Final results are.expected in‘the next few
=a The WARF project apparently will be the first to report’
among a number of government and ——" sponsored animal research

programs currently gathering data on saccharin safety. for human use.

B. As a part of its continuing commitment to evaluate all new

saccharin data, the FDA has been sending experts to Wisconsin to

‘ monitor final phases of the study and to obtain data necessary for

confirmatory analysis.

C. Although this feeding study is still in progress, preliminary
reports indicate abnormal findings of bladder tumors in some aninals

exposed to extremely high dietary levels of saccharin. Bladder

“tumors were found at the 5% of total dict feeding level. This is

equivalent to a dosage of 2.5 gm/Kg- body weight. A comparable
human dosage for a 70 Kg (154 1b.) adult would equal 175 gms per
day for a lifetime, roughly equivalent t'o 875 bottles ae a typical
diet soft drink per day. Clearly, the animal exposure is many times
higher than the highest expected daddy usage in humans, Rats tested
at 0.05% of total dict show no adverse effects so far. This expo-

sure is more comparable to that in humans, Further details, including

‘Tt.

-outcome of current research."

aie.

possible carcinogenicity in the bladder abnormalities, are under
continuing consideration, If saccharin were found to induce cancer,

the law would require it‘to be banned from food.

Dd. Currently, other studies of saccharin in laboratory animals
are being conducted in the USA and abroad. Most of these studies
will be completed within the next few months, Additional data will,

therefore, be available in the near future.

"Ee ‘Although lifetime animal studies by FDA scientists are still

incomplete, no abnormal findings are evident in its work to this —
point. Except for the preliminary and stj1ll tentative report from

WARF, the FDA is unaware of adverse findings from non-FDA research.

F. As a longer range research objective, FDA plans to evaluate
hazards posed by substances causing tumors in animals when given
at relatively high doses by performing additional studies using larger

numbers of animals exposed to test substances at levels more con-

parable to human use. Such studies will be one of the primary

Yesponsibilities of the National Center for Toxicological Reseerch

at Pine Bluff, Arkansas, jointly sponsored by FDA and EPA,

Recent Activity
A. In June 1971, the FDA formally proposed to remove saccharin
from the GRAS (Generally Recognized as Safe) list of food additives

and place the substance under limited regulatory control "pending

a? a3e

B. The June action followed a special NAS/NRC study requested
by the FDA. Commissioner in 1970 to review all available informa-
tion on sxecharin,

The NAS/NRC panel stated that "on the basis of available in-
formation, the present and projected Gaase of saccharin in the
United ehaces does not pose a —t - |

the NAS/KRC reviewers further concluded: (.) that in the
anbeeees of sei limitations on aakly intake “ghoul be estiab-
lished; = @.) that an intake of up to 15 ‘milligrams per kilo-
gram of body weight per day would not constitute an appreciable

— to humans, (This ‘ Keuiwalent to about 1 gram per day
for an adult weighing approntmebely 155 sameiel”
The NAS/KRC also alicia further research and that pace
charin be "frozen" at then current use "Seamed w until the further
research could be carried out. NAS/NRC asked that "when work
now in progress and additional tests recommended in this report
are — | the question of safety of — = for use in foods
on should again ——— .
? These recormendations and findings were reflected in the FDA
ae published in the FEDERAL REGISTER June 25, 1971.
| ‘This FDA saccharin proposal was the first step in an overall

Agency program to review more than 600 food additives on the cur-
rent GRAS list. The decision was made to initiate steps to remove
‘saccharin from the list of substances generally recognized as safe

because FDA criteria for consideration as GRAS do not allow list-

ing of substances requiring limitations on use for safety reasons.

III. Background

A. Saccharin has been used as a non-nutritive sweetner in foods
ts and beverages for nearly a century. It is the oldest known

artificial sweetner,.

‘B. With the removal of cyclamates from the market two years ago,

‘saccharin is the only artificial sweetner currently available. |

eo It is 300 to 500 times as sweet as sugar and ten times as sweet

as cyclamate,

Cc. Until’ the final action on the aaa 1971 proposal by FDA, the
only restrictions on its — those imposed by good ——
turing practices, current labeling regulations requiring its
declaration, or its limited acceptance by a people due to a

' bitter aftertaste,

D. Many physicians consider saccharin useful in the diamegemant of
. diabetes because it permits sweetening of foods without adding
“. carbohydrate and thus, encourages patient adherence to dietary regi-
‘meris. Many diabetic patients Inve Sousa that it nels the mono-
— oe ee diabetic diet. It is also

used in the management of obesity. Saccharin has no specific

therapeutic effect on diabetes or any other disease.

E. A number of questions have been raised about the safety of
saccharin use by humans. Reviews of the scientific evidence sup-
es have been accomplished pericdically in recent
years, This includes reviews conducted by the NAS/NRC at FDA

request in 1968 and again in 1970,

IV.

Comnent

A. FDA's position on saccharin has reflected the 1970 con-

~ elusions by the NAS/NRC study that saccharin is safe, based on

the "80-year history of saccharin use by man without evidence of

adverse effects," plus a lack of evidence of carcinogenicity in

" ‘the animal studies ee to that. time,

B. the FDA also lise ) foblowed the NAS/KRC recommendation that Adit Etenal

" etudies be made over — pemseye of time to further paaieate

sabes: This is now being deus chivough aa studies by FDA,

the National Cancer Institute — by a number of PELisee sponsors,

including the Sugar Research Foundation through WARP,

' C. The FDA bears direct responsibility and must consider all

questions of saccharin use in both foods and drugs.

D. The use of saccharin in food is closely prescribed by the

_ Delancey clause in the 1958 Food Additives Amendment to the Food,
Drug, and Cosmetic Act of 1938. This clause disallows the use

. of any substance as a food additive if shown to induce cancer

when fed to animals, ,

E. Use of saccharin in drugs is a more complex matter. The

Delaney clause does not apply to such use and under present law

final judgments rest with the FDA,

F. Present use of saccharin in drugs is twofold:
1, -It is used in the management of diseases or condi-
. tions such as diabetes or obesity.
2. It is used as a sweetening agent to make certain druys
palatable. The principal application is in pediatric thers...
Conclusions
A. With respect to food usage of saccharin:
-1, FDA will continue to monitor the WARF study pending
completion and review of final results; other testing in

progress is also being monitored.

2, The NAS/NRC, at the request of FDA, has agreed to revie::

the final WARF study results when available, along with

other experimental research data expected in the near

future. Specifically, NAS/NRC, in the course of its con-

tinuing review, will: ‘ g ~*~ 8" ~ oe

aot (a) evaluate the scientific validity of all available

laboratory findings, and

’

- (b) reconmend when those findings are sufficient to cons."

that saccharin is or is not carcinogenic when

administered orally to test animals.

3. FDA is publishing in the FEDERAL REGISTER a final order
removing saccharin from the GRAS List and providing limited
food additive approval to restrict the use of Saccharin in
foods pending results of continuing scientific review. A

copy of the FEDERAL REGISTER Notice ,is attached,

4. Further decisions on saccharin use in foods will be

made on the basis of all available scientific findings

and their application as prescribed ‘by law.

the use of saccharin in drug products is subject to the same

risk-to-benefit assessment as are other substances in drvgs,

Therefore;

1. FDA’ will continue to weigh the evidence as it becomes

| vevailable, indbediens the necessity and feas ibility of sac-

charin use in ‘the formulation of déuss and in the management

of medj.cal conditions where dietary regulation is important,

2. ‘he FDA has requested expert advice from the Institute

of Medicine on these matters as the basis for appropriate

action under the Food, Drug, and Cosmetic Act.

TITLE 21--FOOD AND DRUGS

| . CHAPTER I--FOOD AND DRUG ADSUNISTRATION,
| , = ©, DEPARIMENT OF HEALTH, EDUCATION, AND WELFARE

SUBCHAPTER B--FOOD AND FOOD PRODUCTS
PART 121--FOOD ADDITIVES

SACCHARIN AND ITS SALTS

‘In the FEDERAL REGISTER of June 25, 1971 (36 F.R. 12109), the Connissioner

of Food — Drugs propescd removing, saccharin and its salts from the generally
‘recognized as safe (G RAS) list in § 121.101(d) (21 CFR 121.101(d)) and
‘permitting balls continued use within safe linits by adding a new regulation
a 121.4001) providing provisional food additive status for saccharin and its
salts used as sweeteners to — a sient treant reduction in the calorie
value of the food. ‘Twenty-one Jetters containing various comments were

“ received in response to the proposal. These comments have been analyzed and
as a result several changes have been made in the proposed regulation. In

' general, most of the comments agreed with the purpose of the proposal.

Seven comments were concerned with uses of saccharin for technological

- aed
-

PURPOSES other than calorie reduction. Thes e technolosical perpuses were to

reduce inte and mask flavors in vitamin dnd mineral preparations, to enhance

. the flavor of individual flavor chips used in nonstandardized bakery products,

and to retain the flavor and physical properties of chewing gum. Information
_ provided in these comments indicates that the contribution to the daily

intake of the additive from these uses would be demonstrably small.

«Be

Thus, the Commissioner considers it appropriate to permit these specific
technological uses. Petitions will have to be filed in order to obtain
authorization for additional technological- uses not provided for in the
regulation.,

Five comments concerned the proposed limitation of saccharin to 7

. milligrams per fluid ounce in beverages containing other sweeteners. This
proposed limitation has been deleted in the interest of simplification and
because the overall limitation of 12 milligrams per fluid ounce in beverage

“and fruit juices will adequately restrict the use of saccharin to safe Levels
— the period provided. The dry iexemess bases are also included in the
Limitation for saccharin in beverages. The limitation is to be applied be
the beverage prepared from the base according to the label directions.

A few comnents were received relating to the Hammers woreinn of the other
limitations, Some revisions in text have been made in the interest of clarity.
Contnents were made relating to the necd for’ declaring a size of serving.

a“

Rather than attempt to establish serving sizes for commodities of varying

densities, the Commissioner has decided to establish the limitation for
, ‘
saccharin on the basis of a serving of designated size. This will require a

label. statement concerning the size of a normal serving and thereby indicate

the amount of saccharin in that serving.
a
A majority of cownents concerned the labeling requirements on the basis

that the statement of saccharin concentration in milligrams per fluid ounce

or per serving will be in addition to the percentage statements already

a 3s

required by §§ 125.7 and 3.72 (21 CFR 125.7 and 3.72). No additional
be

label declaration willfrequired in the case of combinations of nutrient

and non-nutritive sweeteners in "diet beverages" because § 3.72, which

deals with such products, presently rNguENEE the declaration of
saccharin content both by percentage and by milligrams per fluid ounce.
Similar declarations in the case of other foods would not appens ‘ks
be an excessive labeling burden. Such joint declaration would further
assume that no future label alesis would be needed if either requirement
were later deleted. : cea. 6
Several of the comments concerned the need for time in which to

implement labeling changes. A reasonable time will be allowed for
labeling changes by requiring that the changes be reflected in the next
order th elcid neal in any event, chat’ ane labels be used de all
products sold after July 1, 1972.

. This approval oe Bibidiantn for limited wee dn food is an interim
: gee i Fs .

measure. Studies on chronic feeding of saccharin to animals are being
conducted by the Food and Drug Administration and other groups.
reolinnney results indibeade possible adverse effects, Should the
experimental findings indicate that continued use of saccharin and its
salts does lnwelve a significant risk to the public health, action will
be taken as warranted to minimize such risk. Notwithstanding this
provisional sepulaiiion it is possible that this action would include

SS
the withdrawal of approval for use of saccharin jn food. ~

B |

“of

Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic
Act (sec. 409(d), 72 Stat, 1787; 21 U.S.C. 348(d)) and under authority delegated

to the Commissioner (21 CFR 2.120), Part 121 is amended:

1. By deleting § 121.101(d)(4). =

2. By adding a new Subpart H consisting at this time of one section, as
. follows:
SUBPART H--FOOD ADDITIVES PERMITTED IN FOOD FOR IJMAN CONSUMPTION,
OR IN CONTACT WITH FOOD, TOR LIMITED PERIODS OF T1HE

‘-- §.121.4001 Saccharin, ammonium saccharin; calcium saccharin, and sodium
saccharin, se

The food additives saccharin, ammoniim saccharin, calcium saccharin,
and sodium saccharin may be safely used as sweetening agents in food in
accordance with the FoTlenine conditions, if the substitution dice nutritive
sweeteners is for a valid special dietary purpose and bs in accord with
current epdtial Stouary food regulations and policies or if the use or intended
use is fox oe ee purpose other than calorie reduction:

(a) Saccharin is the chemical 1,2-benzi sothiazolin=3-one-1,1-dioxtde
(C7115NO3S) . — salts of saccharin are produced by the additional
“neutralization of saccharin with the proper base ea pend the desired salt.

(b) The food additives meet the specifications of the "Food Chemicals
Codex." , |

_(c) Authority for such use shall expire June 30, 1973, unless revised

sooncr.

—

‘(d) ‘The aGiretues are used or intended for use as a sweetening spent
only in special dietary foods, as follows:
QQ) In beverages, fruit juice okie, sind bases or mixes when prepared
‘ for consumption jin accordance with directions, in amounts not to exceed
42 milligrams of Ge additive, saleate ted i boeshavtn, per fluid ounce...
aa ; (2) As a sugar substitute for cooking or- table use, in amounts not to
exceed 20 milligrams of the additive, calculated as saccharin, for each
‘ expressed teaspoonful of sugar sweetening equivalency.
.@)~ In processed foods, in anounts not to exceed 30 milligrams of the
“additive, calculated as saccharin, per serving of.designated size.
Ac) The additives are used or intended for use only for the following
. technological ee |
Q) To reduce bulk and enhance flavors in chewable vitamin tablets,

chewable minera] tablets, or combinations thereof.
* (2) To retain _— and physical properties of chewing gum.
Q).. To enhance flavor of flavor chips used in nonstandardized bakery
a |
(f) To assure safe use of the additives, in addition to the other informa-
tion required by the act:
(1) The label of the additive and any intermediate mixes of the additive
for manufacturing purposes shall bear:
(i) the name of the additive.
(ii) A statement of the concentration of the additive, expressed as

saccharin, in any intermediate mix.

. 6

(ili) Adequate directions for use to provide a final food product that
complics with the limitations prescribed in paragraphs (d) and (e) of this

section.

(2) The label of any finished food product containing the additive shall
bear: 7 |

(4) The name of the aaaeeiue.

(ii) The amount of the additive, caluviaced ax —— as follows:

{a) For beverages, in milligrams per fluid ounce;

(b) For cooking or table use products, fe milligrams per dispensing unit;

‘(c) For processed foods, in terms of the weight or size of a serving

which shall be that quantity of the food containing 30 milligrams or less

of the additive, ™

(i3i) When the additive is used for calorie reduction, such other labeling

as is required by Part 125 or $ 3.72 of this chapter.

o Tx

Any person who will be adversely affected _ the fosenotan
order may at any time within 30 days after its date of publication
in the FEDERAL REGISTER file with the leaving Clerk, Department
of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane,
Rockville, Md, 20852, _ objections thercto in quintuplicate,
Objections shall show wherein the _— filing will be adverscly
affected by the order sail specify with particularity the provisions
of the order deemed objectionable and the grounds for the objections.
If a hearing is sxauenved. the objections must state the issues for
the hearing. A hearing will be granted if the objections are supported
by a © legally sufficient to justify the relicf sought. Gbiecelons
may be accompanied by a memorandum or brief in support thereof. Received
sirnantens may be seen in the above office during working hours, Nonday
through Friday. Z

Effective date. This order shall be effective upon publication

- ,in the FEDERAL RLGISTER except fox the labeling changes required by

§ 121.4001(f). These labeling changes must be reflected in all labels

wen

ordered after the date of publication of this order and, in any event,
“must be reflected in labels used on all affected products sold after
July 1, 1972,

(Sec. 409(d), 72 Stat. 1787; 21 U.S.C. 348(d))

— Ohad. 29, (97% . . A,
[ft hj

Remarks by Hone James Je Delaney, Me Cs ( Des 7th Diste, Ne Ye )

in the House of Representatives, April , 1958e)

CANCER end CHEMICALS

Mare Speaker, for many years I have been pressing for
the enactment of legislation to prohibit the use of chemical
additives in foods unless adequate tests have first demonstrated
that they are safe for uses

A recent ruling proposed by the Food and Drug Adminis-
tration points up the necessity for this legislations

This is a ruling against 2 pesticide called Aramite,
which is mown to induce cancer in test enimals.

For over two years , cancer experts have been warning
that this pesticide is not safe for humen consumption in any
amount

Nevertheless, FDA has permitted its use on apples,
blueberries, canteloups, celery, cucumbers, grapefruit, grapes,
green beans, lemons, muskmelons, oranges, peaches, pears,
pluus, raspberries, strawverries, sweet corn, tomatoes and
watermelonse

My food additive bill, He Re 7798, in addition to
requiring the pre-testing of chemical edditives to prove safety,
would specifically ban the introduction into food of any

cancer=inducing chemical.

=
a

-3-

This committee met in Washington on July 27, 1955, and
following a morning and an afternoon session, issued three
recommendations;

"]) That a residue tolerance of 1 part per million be
established for Aramite under the provisions of Public Law 518,
83rd Congress,"

However, the committee apparently was not convinced that
Aramite was harmless, because it also recommended:

"2) That the petitioner be advised to secure acceptable
data on the chronic toxicity and carcinogenicity of Aramite at
feeding Levels between zero and 500 parts per million in the
mouse, rat and doge

"3) That the entire problem be reviewed by this or
another committee in 1957, when further laboratory and other
data are available,"

These, surely, were strange recommendations for scien-
tists to make. They admitted that they felt that the data which
they reviewed were insufficient and incomplete, and, in particular,
suggested that more information be secured regarding the cancer
inducing propensities of Aramite, Yet, at the same time, they
were perfcetly willing that the public be exposed to a certain
amount of ite

It is all the more strange when we consider that the
committee had before it reports of tests which showed that Aramite,
when fed in certain concentrations, produced liver injury and

malignant tumors in test animals.

in additton.to requiring the*fire-testing of chemical
er

Q time. ~ Re. ee g
5
:
H

j additives to show safety, sy, pPeent additive bill, He Re 7798,
contains a provision ifeh would speci fic#liy.ban, the introduce

git eX

| tion into food"or any chemical additive found to induce cer in

site tests, found to induce cancer ins
There id Neee strong eepeat iia to this provision,
but the Aramite story shows why it is needed.

Back in February, 1955, as required by Public Law
83-518 ( the pesticide amendment to the Federal Food, Drug, and
Cosmetic Act), the United States Rubber Company filed with FDA
a petition requesting the establishment of tolerances of 2 parts
per million for residues of Aramite, in or on certain fruits and
vegetables, and tolerances of 5 parts per million on certain
other raw agricultural commodities. |

After consideration of the test data submitted, which
included evidence that the chemical induced malignant tumors in
test animals, FDA concluded that the safety of Aramite was ques-
tionable, and published a zero tolerance,

Thereupon, the U. S. Rubber Company withdrew its ori-
ginal petition and submitted a new petition requesting tolerances
for Aramite of 1 part per million in or on the same commodities.
In conformance with a certain provision of the pesticide amend-

ment, the company also requested that the new petition be

referred to an advisory committee of experts for study and

recommendations.e

The Food and Drug Administration accepted the recom=
mendations of the advisory committee, withdrew its previous
ruling, and published a tolerance of one part per million of
Aramitee Once again, as so often in the past, the public became
a guinea-pigs

Now, over two and a half years later, additional tests
show that Aramite, fed at a significantly lower concentration than
that considered by the advisory committee, tended to cause liver
tumors in rats, and produced liver damage and malignant tumors in
the livers and bile ducts of dogs.

Here, it seems to me, is a perfect example of the appar-
ent willingness of government to acconpdate big business and let ( “
the public take the risk,

At the time of its original ruling, the Food and Drug
Administration had on hand evidence to show that Aramite, so far
as the public health was concerned, was at least a suspicious pro-
duct. Under the law, FDA was not required to accept the recommenda-
tions of the advisory committee and grant any tolerance of the
chemical.

The Food and Drug Administration is to be commended on
admitting its mistake and publishing its present proposed ruling.
However, that does not remove the possible effect that Aramite
may have had on the public during the period in which its residues

have been permitted,

eg a eee ee ee aa = ey SO eS . Lea eee re a ey eg eee a Yee eee

e -5-

Mr. Speaker, the significance of FDA's former ruling
on Aramite was that for the first time a precedent was set that
might give legal sanction to the introduction of so-called "safe"
quantities of cancer=inciting additives into foods

I first brought this to the attention of the Congress on
February 21, 1957, when I placed in the Congressional Record a
letter written to me by a noted cancer researcher, Dre William
Ee Smithe

Dre Smith has had a brilliant research career and at
various times has been on the staffs of the Harvard Medical
School, the Rockefeller Institute for Medical Research, the
Sloan-Kettering Institute for Cancer Research, and was at one
time ar associate professor of industrial medicine at New York
University. At present, he is doing research at the Fairleigh
Dickinson University and is secretary of the Cancer Prevention
Committee. Dre Smith is a dedicated scientist, and a courageous
man who has not hesitated to tangle with the industries in attack=-
ing practises which he has felt might endanger the public health.

It was after several discussions and much correspondence
with Dre Smith that I revised my earlier food additive bill, H. R.
4014, and introduced He R. 7798, which contains the carcinogen
prohibition, and is the only additive bill which does so,
except for an identical bill, He. R. 7938, introduced by the dis-
tinguished gentlewoman from Missouri ( Mrs. Sullivan).

aha

( Here I should like to pause a moment to express my
appreciation for the strong support that our mich admired colleagus
from Ste Louis has given in this food additive issue. She has
spoken eloquently on the floor of the House on this subject, has
given radio talks, has conferred with women's groups and consumer
organizationse Her interest and concern have been a most valuable
contributione)

The carcinogen provision, which I have mentioned, follows
the unanimous recommendation of the International Union Against
Cancer at its Symposium in Rome in August, 1956. This symposium
was attended by over 40 cancer experts from some 20 countries,

The recommendation stated:

"The Conference recommends that, as a basis for active
cancer prevention, the proper authorities of various countries
promulgate ond enact adequate rules and regulations prohibiting
the addition to food of substances having potential carcinogeni-
citye"

The two following recommendations were also unanimously
approveds

"1) Food additives should be permitted only if, after
long-term administration to at least two species of animals (one
preferably e non rodent), orally and parenterally, in amounts
which must be considerably higher than would be present in food,
and, after observation of the animals over their life-time, and
through at least two generations in at least one suitable species,

they have no toxic effecte

-7«

"2) Any substance which causes cancer in man or which,
when tested under these conditions, is shown conclusively to
be a carcinogen at any dosage level, for any species of animal,
following administration by any route, should not be considered
innocuous for human consumptions"

The original tests showed that Aramite did not meet these
criteria of safety. The later tests were even more con=-
clusive regarding its potentiality for harm. Of course, the
International Union Against Cancer is not an American organization,
although some distinguished American dre members of it, but it
does represent the advanced thinking of ea world group of cancer

authoritiese spss anenesanemnaneeaaienattinieias ee
Fae SI EIT TRE — gee
the past @ Subcommittee on [
i : = — ;
Health 10 ci Bama ts @ great deal of tiie and serious i
H
study eae fol the ‘Ponaseaisive * bills pending in this i

vent as Ben

Congrésse a ea ee |
AgT have + saben > He Re “7798, ie... “ath. ~ 4
aly SEL which specifically t bans the use of — ,

isi Rae wes a
* oS hy ae rts NE Si

ae poinogense- te 1148

ie—-bhie;p st not only follows the recommendations of
the International Union Against Cancers but also conforms with
gapeesaiahdiss of the American Cancer Societys
A letter sent to the Subcommittee on Health and Science
on July 22, 1957, by Mre James S, Adams, Chairman of the Legis-
lative Committee of the American Cancer Society, states as

follows:

- B-

"We strongly urge that your Committee recommend legis-
lation to the Congress to strengthen the Food and Drug Adminis-
tration and thet this legislation embrace the following principles:

"]) That the proponent of any proposed chemical additive
be required to conduct tests which will demonstrate that the addi-
tive is safe for human consumption in the manner in which it will
be used, and that these tests include one to determine whether the
additive may be carcinogenic to experimental animals. The
adequacy of these tests should be determined by the Food and Urug
Administration.

"2) That permission to use the additive be withheld
until its safety has been demonstrated to the satisfaction of the
Food and Drug Administration by the proponent.

"3) That no substance shall be approved found to in-
duce cancer in man, or after tests provided in Noe 1 above,
found to induce cancer in animals,"

He Re 7798 is supported by such authorities as Dre
William C. Hueper, the distinguished head of the Environmental
Cancer Section of the National Cancer Institute, who testified
before the committee in an unofficial capacity, Dre Francis 5.
Ray, Director of the Cancer Research Laboratory of the Univer=
sity of Florida, Dre Alton Ochsner, head of the Ochsner Clinic
of New. Orleans and a famous cancer surgeon, and Dre We Coda
Martin, President of the American Academy of Nutritione It is
also supported by a very large number of consumer organizations
and labor unions, members of which have a direct interest as

consumnerse

Mre Speaker, it is appalling to think that one out of

every four persons in this country will at some time or another
suffer from cancere While we may not yet completely understand
the part that chemical additives play in the cancer picture,
enough is known to put us on our guards

In my last appearance before the Health and Science
Subcomuittee on the 15th of this month, prior to the new FDA
ruling, I stated; "The precedent established by the Aramite
decision has opened the door, even if only a little, to the use
of carcinogens in our foods. That door should be slammed shut
and locked,"

It is my firm purpose to do just thate

Surely there is nothing of greater importance to any
nation than the health of its people.

We have a serious responsibility in this field. It is
urgent that we meet it as soon as possible, and as completely

as possiblee

ioo% : "
‘eA, (Sheen iy es.

Mr. Speaker, for over two and a half years the use of

a pesticide capable of inducing cancer in animals has been per-
mitted on certain of our fruits and vegetables.

During this time, it has been legal for a residue of

vw hg Ct bentrtu,

one part per million of this rca’: remain on apples, blue-
berries, cantaloups, celery, cucumbers, grapefruit, grapes, greet-
beans, lemons, muskmelons, oranges, peaches, pears, plums, rasber=-
ries, strawberries, sweet corn (kernels) but not the forage thereof,
tomatoes and watermelons.

In what I consider an indefensibly belated action, last
Saturday the Food and Drug Administration published in the Federal
Register a proposed ruling which would rescind the present regu-

permitting
lation/a residue tolerance of one part per million of this
instead

chemical, and BEEMEXXKMXHE establish/a zero tolerance, thus
prohibiting the interstate shipment of raw agricultural commo-
dities containing any trace of ite

Mre Speaker, for many years I have been fighting for the
enactment of legislation to prohibit the use of chemical additives
in foods unless adequate tests have demonstrated that they are
safe for usee

Mye present bill, H. Re 7798, contains a provision which
would specifically ban the introduction into food of any chemical
additive found to induce cancer in man, or, after tests, found
to induce cancer in animals. ‘

There has been strong opposition to this provision, but

I think the story of the present FDA ruling will show why it is

needed.

As required by Public Law 83-518 ( the pesticide amend-
ment to the Federal Food, Drug, and Cosmetic Act) in February, 1955,
the United States Rubber Company filed with FDA a petition
requesting the establishment of tolerances of 2 parts per million
for residues of Aramite in or on certain fruits and vegetables,
and tolerances of 5 parts per million on certain other raw agri-
cultural commodities,

After consideration of the test data bubmitted, FDA
concluded that the evidence showed that the safety of Aramite was
questionable, and published a zero tolerance,

Thereupon, the U. S. Rubber Company withdrew its ori-
ginal petition and substituted for it a petition requesting
tolerances for Aramite of 1 part per million in or on the same
commoditiese In conformence with a certain provision of the pes-
ticide amendment, the company also requested that the new peti-
tion be referred to an advisory committee of experts for study
and recommendations.

This committee met in Washington on July 27, 1955, and
following a morning and an afternoon session, issued three
recommendationse

"]) That a residue tolerance of 1 part per million be
established for Aramite under the provisions of Public Law 518,
83rd Congress."

However, the committee apparently was not entirely
convinced as to the safety of Aramite, because it also recom=

mended:

-3-

"2) That the petitioner be advised to secure accept-
able data on the chronic toxicity and carcinogenicity of Aramite
at feeding levels between zero and 500 parts per million in the
mouse, rat and doge

"Z) That the entire problem be reviewed by this or
another committee in 1957, when further laboratory and other data
are available."

These, surely, were strange recommendations for scien=
tists to makes They admitted that the data which they reviewed
were insufficient and incomplete, and, in particular, suggested
that more information be secured regarding the cancer inducing
propensities of Aramite. Yet, at the same time, they were per
fectly willing that the public be exposed to a certain amount of
ABAMZESY the pesticide.

It is all the more strange when we consider that the
committeehad before it reports of tests that showed that Aramite,
in certain concentrations, produced liver injury and cancer in
test animals.

Although not required to, for some reason or other
the Food and Drug Administration accepted the recommendations
of the advisory committee and published a tolerance of one part

per million of Aramite. Once again, the public became a guinea

pige

Now, over two and a half years later, FDA finds that
additional tests show that Aramite, fed at a much lower concen-
tration than that considered by the advisory committee, tended to
cause liver tumors in rats, and produced liver damage and malig-
nant tumors in the livers and bile ducts of dogs.

Here, it seems to me, is a perfect example of the ap-=
parent willingness of the executive branch of the government to
accomodate big business and let the public take the risk.

At the time of its original ruling, the Food and Drug
Administration had on hand sufficient evidence to show that Ara-
mite, so far as the public health is concerned, is at least a
suspicious product. Under the law, FDA was not required to ac=
cept the recommendations of the advisory committee and revise
its ruling to permit any tolerance of the chemical.

I commend the Food and Drug Administration on admit-
ing its mistake and publishing its present proposed ruling to
rescind the tolerance. However, that does not remove the pos-
sible effect of Aramite on the public during the period in
which its residues have been permitted.

Mr. Speaker, the significance of FDA's former ruling on
Aramite was that for the first time a precedent was set that might
make possible the introduction of so-called "safe" quantities

of cancer-inciting additives into food.

I brought this to the attention of the Congress on
February 21, 1957, when I inserted in the Congressional Record
a letter written to me by a noted cancer researcher, Dr. William
E. Smith. Dr. Smith has had a brilliant research career and at
various times has been on the staffs of the Harvard Medical
School, the Rockefeller Institute for Medical Research, the
Sloan-Kettering Institute for Cancer Research, and was at one
time an associate professor of industrial medicine at New York
University. At the present time, he is doing research at the
Fairleigh Dickinson University and is secretary of the Cancer
Prevention Committee. Dr. Smith is a dedicated scientist, and
a courageous man who has not hesitated to tangle with the
industries in attacking practises which he has felt might en-
danger the public health.

It was after several discussions and much correspon=
dence with Dr. Smith that I revised my earlier food additive bill,
He Re 4014, and introduced H. Re 7798, which contains the
carcinogen prohibition, and is the only additive bill which does
SOe

This provision follows the unanimous recommeridation of
the International Union Against Cancer at its Symposium in Rome
in August, 1956.

The recommendation stated:

"The Conference recommends that, as a basis for active
caner prevention, the proper authorities of various countries
promulgate and enact adequate rules and regulations prohibiting
the addition to food of substances having potential carcinogeni-
city."

The two following recommendations were also unanimously
approved;

1) Food additives should be permitted only if, after
long-term administration to at least two species of animals ( one
preferably a nonprodent), orally and aprenterally, in amounts
which must be considerably higher than would be present in
food, 48 so as to give adequate margin of safety, and, after
observation of the animals over their life-time, and through at
least two generations in at least one suitable species, they
have no toxic effect.

2) Any substance which causes cancer in man or which,
when tested under these conditions, is shown conclusively to be
@ carcinogen at any dosage level, for any species of animal, fol-
lowing administration by any route, should not be considered
innocuous for human consumption."

The original tests showed that Aramite did not meet
these standards of safety. The later tests were even more con-

clusive regarding its potentiality for harm.

-T-

Mre Speaker, during the past year the Subcommittee on
Health and Science has given a great deal of time and study in
considering the food additive bills pending in this Congress.

As I have stated, my bill, He Re 7798, is the only one
which specifically bans the use of carcinogens. The Aramite in-
cident emphasizes the necessity of such a provisions

He Re 7798 not only follows the recommendations of the
International Union Against Cancer, but also conforms with the
recommendations of the American Cancer Society.

A letter sent to the Subcommittee on Health and Science
on July 22, 1957, by Mre James S, Adams, Chairman of the Legis-
lative Committee of the American Cancer Society, states as fol=-
lows:

believe

"We BSHETAXKE that in considering the health problem cre=-
ated by the increasing use of chemical additives in food the
adage *an once of prevention is worth a pound of cure? is partic-
ularly applicable.

"We strongly urge that your Committee recommend legis=
lation to the Congress to strengthen the Food and Drug Adminis-

tration and that this legislation embrace the following principles:

"1) That the proponent of any proposed chemical additive
be required to conduct tests which will demonstrate that the addi-
tive is safe for human consumption in the manner in which it will
be used, and that these testis include one to determine whether
the additive may be carcinogenic to experimental animals. The
adequacy of these tests should be determined by the Food and Drug
Administrations

"2) That permission to use the additive be withheld
until its sefety has been demonstrated to the satisfaction of the
Food and Drug Administration by the proponent.

"3) That no substance shall be approved found to in-
duce cancer in man, or after tests provided in Noe 1 above,
found to induce cancer in animals."

He Re 7798 is supported by such authorities as Dr.
William Ce Hueper, the distinguished head of the Environmental
Cancer Section of the National Cancer Institute, who testified
before the committee in an unofficial capacity, MMM Dr. Francis
E. Ray, Director of the Cancer Research Laboratory of the Univer=
sity of Florida, Dr. Alton &% Ochsner, head of the Ochsner
Clinic of New Orleans and a famous cancer surgeon, and Dr.

We Coda Martin, President of the American Academy of Nutritione
It is also supported by a large number of EXX consumer organi-
zations and labor unions, members of which have a direct interest

as consumerse

~9=

Mre Speaker, it is appalling to think that one out of
every four persons in this country will at some time or another
suffer from cancere While we may not yet completely understand
the part that chemical additives pley in the cancer picture,
enough is known to put us on our guards

To come back to Aramite, in my last appearance before

on the 15th of this month
the Health and Selence Subcommittee/I stated; "The precedent
established by the Aramite decision has opened the door, even
if only a little, to the use of carcinogens in our foods That
door should be slammed shut and lockede't

It is my firm intention to do everything I possiblg
can to BXMMAYSMNKX slam the door shut, lock it, and keep it
lockede To that purpose, I am studying the pesticide section

of the Food, Drug and Cosmetic Act, with the thought of intro-

BARI

ducing en anti-carcinogen xiii amendment to ite Cer=
tainly any food additive bill without a carcinogen prohibition
would be inadequate.

The large volume of mail which I continue to receive
from people all over the country expresses their concern with
the chemical additive problem in general, and the chemical
additive problem as related to cancer in particular, They cannot

understand why action has been so long delayed.

eT ye

Surely there is nothing of greater importance to any
nation than the health of its peoples We ninve a serious respon=
sibility in this field, and it is urgent that we meet it as soon
as possible, and as completely as possible.

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Date Uploaded:: November 29, 2023

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James Joseph Delaney Papers, 1950-1978

Collection ID	apap241
Total components	559
Items available online	4
Last indexed	2025-07-29

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Chemicals in Our Food can Cause Cancer (Aramite Chemical Speech), Statement, 1958 April

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