83p CONGRESS uo R
1st Session 2 2 44
@ r)
IN THE HOUSE OF REPRESENTATIVES
JANUARY 29, 1953
Mr. Deanery introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act by pro-
viding for the regulation of chemicals in cosmetics.
1 Be it enacted by the Senate and House of Representa-
bo
tives of the United States of America in Congress assembled,
3 That section 201 of the Federal Food, Drug, and Cosmetic
fan)
+ Act is amended by adding the following paragraph:
oO
“(r) The term ‘cosmetic chemical’ means any sub-
6 stance which (1) is intended for use (A) as a cosmetic
7 or component thereof, or (B) to preserve or alter any cos-
8 metic or any characteristic of any cosmetic; and (2) is not
9 generally recognized, among experts qualified by scientifi¢
10 training and experience to evaluate the safety of such sub-
11 stances, as having been adequately tested to show that it is
Vi
24
25
2
not poisonous or deleterious, or is a poisonous or deleterious
substance which is not generally recognized by such experts
as having been adequately tested to show that it is safe
for use in cosmetics.”
Src. 2. Section 201 (i) (2) of such Act is amended
by changing the semicolon to a period and deleting the words
“except that such term shall not include soap”.
Src. 3. Section 301 of such Act is amended by chang-
ing “404 or 505” in subsection (d) to “404, 505, or 605”;
and “404, 505, 506, 507, or 704” in subsection (j) to
“404, 505, 506, 507, 605, or 704”.
Src. 4. Section 304 of such Act is amended by chang-
ing “404 or 505” in subsection (a) and (d) to “404, 505,
or 605”.
Src. 5. Section 601 of such Act is amended by chang-
ing subsection (a) to read as follows:
“(a) If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the
conditions of use prescribed in the labeling thereof, or under
such conditions of use as are customary or usual: Provided,
That this provision shall not apply to articles containing
any coal-tar or intermediate thereof which coal-tar or inter-
mediate thereof alters the color of the hair, when such articles
are applied to the hair under the conditions of use prescribed
in the labeling thereof or under such conditions of use as are
3
customary or usual, if the Administrator by regulation finds
that such articles may be used by the public without likeli-
hood of harm and the label of which bears the following
legend conspicuously displayed thereon: Caution—This
product contains ingredients which may cause skin irritation
on certain individuals and a preliminary test according to
accompanying directions should first be made. This product
must not be used for dyeing the eyelashes or eyebrows. It
must be kept out of the eyes and away from the areas around
the eyes. Failure to follow these instructions may result
inblindness.’, and the labeling of which bears adequate
directions for such preliminary testing. For the purposes of
this paragraph and paragraph (e), the term ‘hair dye’ shall
not include eyelash dyes or eyebrow dyes.”
Sec. 6. Section 601 is further amended by adding the
following paragraph:
“(f) If it bears or contains any cosmetic chemical,
unless the use of such cosmetic chemical in such cosmetic
has been approved pursuant to section 605.”
SEC. 7. Section 602 of such Act is amended by adding
the following paragraph:
“(e) Unless its labeling bears (1) the common or usual
name of the cosmetic chemical, and (2) in case it is fabri-
cated from two or more ingredients, the common or usual
name of each such ingredient: Provided, That to the extent
+
that compliance with the requirements of clause (2) of this
paragraph is impracticable, or results in deception or unfair
competition, or is not in the best interest of the consumer,
exemptions shall be established by regulations promulgated
by the Administrator.”
Sec. 8. The following section shall be added to chapter
VI of such Act:
“COSMETIC CHEMICALS
“Sec. 605. (a) No person shall introduce or deliver for
introduction into interstate commerce any cosmetic chemical,
unless the use of such cosmetic chemical has been approved
pursuant to subsections (d) or (e).
“(b) Any person may file with the Administrator a
request for the issuance of an order approving the use of a
cosmetic chemical. There shall be submitted to the Admin-
istrator as a part of the request (1) reports of investigations
which have been made to show the acute and chronic toxic-
ity and other potentiality for harm of the cosmetic chemical ;
(2) a statement of the composition of the cosmetic chemical ;
(5) a description of methods of analysis for the quantitative
determination of the cosmetie chemical in or on cosmetics,
including gnimal tissues if stored therein; (4) such samples
of the cosmetic chemical as the Administrator may require ;
and (5) all directions, recommendations and suggestions
proposed for the use of the cosmetic chemical.
5
1 ““(c) After the use of a cosmetic chemical has been ap-
2 proved, the applicant may file a supplemental request setting
3 forth any proposed change in the directions, recommenda-
4 tions and suggestions for the use of the cosmetic chemical or
in any other information in the original request.
On
6 “(d) Unless the Administrator issues a notice of hearing
7 pursuant to subsection (e) prior to the sixtieth day after the
sg date on which a request or supplemental request is filed, the
9 request or supplemental request shall be deemed to have
10 been approved on said sixtieth day for the uses specified ;
11 but the Administrator may issue an order approving the re-
12 quest or supplemental request at an earlier date or may post-
13 pone the date on which the request or supplemental request
14 shall be deemed to have been approved until such time (not
15 more than one hundred and eighty days after it has been
16 filed) as the Administrator deems necessary to enable him to
17 conduct the necessary study and investigation.
18 “(e) Unless a request or supplemental request is ap-
the Administrator
7
19 proved as provided in subsection (d)
20 shall give the applicant an opportunity for a hearing for the
21 purpose of determining whether an order shall be. issued
22 approving the request or supplemental request. As soon
23 as practicable after completion of the hearing, the Adminis-
24 trator shall notify the applicant of his action in approving
or refusing to approve the request or supplemental request.
a Oo ek CO YO
6
If the Administrator finds that (1) the investigations,
reports of which are required to be submitted to him pursu-
ant to subsection (b), do not include adequate tests by all
methods reasonably applicable to show that the cosmetic
chemical is not poisonous or deleterious, or if it is, that it
is safe for its intended use; or (2) the results of such tests
show that the cosmetic chemical is poisonous or deleterious,
and that it is unsafe for such use or do not show that it is
safe for such use; or (3) the methods of analysis for the
quantitative determination of such cosmetie chemical in
cosmetics, including animal tissues if stored therein, are
inaccurate or otherwise inadequate; or (4) he has insuffi-
cient information to determine whether the cosmetic chemical
is poisonous or deleterious, or if it is, whether it is safe for
such use, he shall refuse to approve the request or supple-
mental request. In determining whether to issue an order
approving a request or supplemental request for the use of a
cosmetic chemical and the quantity of such cosmetic chemical
to be permitted in or on a cosmetic, the Administrator shall
take into account the other ways in which the consumer may
be affected by the same substance or other substances. The
Administrator shall make his order, and any order issued:
under subsection (f), only after a review of the whole record
and in accordance with the reliable, probative, and substantial
evidence, and in any such order shall make detailed findings
7
of the facts on which he based his order. Such orders shall be
subject to judicial review in accordance with the provisions
of section 701 (f).
“(f) After notice to the applicant and affording him
an opportunity for a hearing, the Administrator may issue
an order suspending the approval of a request or supple-
mental request with respect to a cosmetic chemical if he
finds that (1) experience in the use of the cosmetic chem-
ical, tests by new methods, or tests by methods not deemed
reasonably applicable when the request or supplemental
request was approved, show that the cosmetic chemical is
unsafe for any use upon the basis of which the request or
supplemental request was approved, or (2) the request or
any supplemental request contains any untrue statement of
a material fact. The applicant may at any time thereafter
request an order terminating the suspension and the Admin-
istrator, if reasonable grounds therefor. are shown, shall
make a prompt investigation and afford the applicant an
opportunity for a hearing. The Administrator shall termi-
nate the suspension if he finds that adequate measures have
been taken to comply with and maintain the provisions of
the request or supplemental request.
“(g¢) The Administrator shall promulgate regulation
exempting from the operation of this section cosmetic chem-
icals intended solely for investigational use by experts quali-
te the
iga
invest
.
lence to
d exper
ining an
ific tra
y scient
1 fied b
‘hemicals.””
smetic ¢
safety of such co
2
SEc. 7. This statute shall take effect six months after
4 the date of its enactment.
“sso HA. R. 2244
A BILL
To amend the Federal Food, Drug, and Cos-
metic Act by providing for the regulation of
chemicals in cosmetics.
By Mr. Drnanry
JANUARY 29, 1953
Referred to the Committee on Interstate and Foreign
Commerce
6
a |
5
shall notify the applicant of his action in approving or refus-
ing to approve the request or supplemental request. If the
Administrator finds that (1) the investigations, reports of
which are required to be submitted to him pursuant to sub-
section (b), do not include adequate tests by all methods
reasonably applicable to show that the chemical additive is
not poisonous or deleterious, or if it is, that it is safe and
required for its intended use; or (2) the results of such tests
show that the chemical additive is poisonous or deleterious,
and that it is unsafe or not required for such use or do not
show that it is safe and required for such use; or (3) the
methods of analysis for the quantitative determination of
such chemical additive in or on food, including animal and
plant tissues if stored therein, or the methods of removal of
excessive portions, are inaccurate or otherwise inadequate;
or (4) he has insufficient information to determine whether
the chemical additive is poisonous or deleterious, or if it is,
whether it is safe and required for such use, he shall refuse
to approve the request or supplemental request. In deter-
mining whether to issue an order approving a request or
supplemental request for the use of a chemical additive and
the quantity of such chemcial additive to be permitted in or
on any food, the Administrator shall take into account the
extent to which such substance is required in or on such food
and the other ways in which the consumer may be affected
83p CONGRESS
ist SEssIon e e 2
A BILL
To amend the Federal Food, Drug, and Cos-
metic Act by providing for the regulation of
chemical additives in food.
By Mr. Detaney
JANUARY 29, 1953
Referred to the Committee on Interstate and Foreign
Commerce
847ruH CONGRESS
ist SEssIoN “ ™
IN THE HOUSE OF REPRESENTATIVES
Ferpruary 28, 1955
Mr. Detaney introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To protect the public health by amending the Federal Food,
10
Drug, and Cosmetic Act so as to provide for the safety of
chemical additives in food.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
That section 201 of the Federal Food, Drug, and Cosmetic
Act is amended by the addition of the following paragraph:
“(s) The term ‘chemical additive’ means any substance
(including products resulting from changes in such sub-
stance after use) which (1) is intended for use (A) as a
food, or (B) to preserve or alter any food or any character-
istic of any food; or (C) for any other purpose in producing,
processing, packing, transporting, wrapping, or holding food
VI
oo arn on eF |! DO
Sa et pe op
Oo bo HM ©
[a S~ —
BP OS oO emo AB ao a &
22
2
if such use is likely to result in the contamination of food, but
shall not include pesticide chemicals used in the production,
storage, or transportation of raw agricultural commodities, as
defined in section 201 (q) of this Act; and (2) is not gen-
erally recognized, among experts qualified by scientific train-
ing and experience to evaluate the safety of chemical addi-
tives, as having been adequately tested to show that it is
not poisonous or deleterious, or is a poisonous or deleterious
substance which is not generally recognized among such
experts as having been adequately tested to show that it is
safe for its intended use.”
Src. 2. Section 301 of the Federal Food, Drug, and
Cosmetic Act is amended by changing “404 or 505” in
subsection (d) to “404, 409, or 505”; and ‘404, 505, 506,
507, or 704” in subsection (j) to “404, 409, 505, 506,
507, or 704”.
Sec. 3. Section 304 of such Act is amended by changing
“404 or 505” in subsections (a) and (d) to “404, 409, or
505”.
Sec. 4. Section 402 (a) of such Act is amended by
changing the period at the end to a semicolon and adding:
“or (7) if it is, or bears or contains, a chemical additive,
unless the use of such chemical additive has been approved
pursuant to section 409.”
ono woneoa a fF WO YD F&
ro —
o bo - 6
mo wp NS BD DH BH SB SB SB SB
F Oo Db FEF SF © wD KH Da EB
8
Suc. 5. The following section shall be added to chapter
IV of such Act:
“CHEMICAL ADDITIVES
“Src. 409. (a) No person shall introduce or deliver for
introduction into interstate commerce any chemical additive,
unless the use of such chemical additive has been approved
pursuant to this section.
“(b) Any person may file with the Secretary an appli-
cation for the issuance of an order approving the use of a
chemical additive. There shall be submitted to the Secretary
with the _—— (1) a statement of the intended use of
the chemical additive and demonstrating that such employ-
ment of the chemical additive will serve a purpose which will
be useful to the consuming public; (2) reports of investiga-
tions which have been made to determine the acute and
chronic toxicity and other potentiality for harm of the chemi-
cal additive; (3) a statement of the composition of the
chemical additive; (4) a description of methods of analysis
for the quantitative determination of the chemical additive,
and its reduction products, in or on food; (5) such samples
of the chemical additive as the Secretary may require; (6)
all directions, recommendations and suggestions proposed for
the use of the chemical additive; and (7) if the chemical
additive is a poisonous or deleterious substance, reports of
o wornrea a Fe WO DH &
Se ef
no - oo
pa:
m 0
ao FF WO NBO HF CO Oo OH DO OH
4
investigations which have been made to show the quantities
of the chemical additive remaining in or on the food and that
it is required for its intended use.
“(c) The Secretary shall issue an order approving the
application within ninety days after the filing of the applica-
tion if the Secretary finds that the reports submitted to him
pursuant to subsection (b) demonstrate (1) that the chemi-
cal additive is not a poisonous or deleterious substance or if
it is that it is safe and required for its intended use, and (2)
that the intended use of the chemical additive will serve a
purpose which will be useful to the consuming public; other-
wise, except as provided in subsection (d), the Secretary
shall issue an order within said ninety days refusing to
approve the application.
“(d) Within said ninety-day period specified in sub-
section (c), the Secretary, when he deems such action ad-
visable or upon notification from the applicant, shall submit
the application and other data before him to an advisory com-
mittee to be appointed pursuant to subsection (f). Within
sixty days after such referral, or within an additional thirty
days if the committee deems such additional time necessary,
the committee, after independent study of the data submitted
to it by the Secretary, shall certify to him a report and
recommendations on the proposal in the application, together
with all underlying data and a statement of the reasons for
=~ WwW bd
23
24
5
the recommendations. Within thirty days after such cer-
tification, the Secretary, after giving due consideration to all
the material, including such report and recommendations,
then before him, shall issue an order approving the applica-
tion if he finds that the chemical additive is not a poisonous
or deleterious substance or if it is that it is safe and required
for its intended use, and that its intended use will serve a
purpose which will be useful to the consuming public; other-
wise the Secretary shall issue an order within said thirty
days refusing to approve the application. In determining
whether a chemical additive is safe under subsection (c) or
(d), the Secretary shall take into account the other ways in
which the consumer may be affected by the same substance
or other substances.
“(e) Within thirty days after the issuance of an order
under subsection (c) or (d), any person adversely affected
may file objections thereto with the Secretary specifying the
reasons he deems the order objectionable and requesting a
public hearing upon such objections. After furnishing due
notice, the Secretary shall thereupon hold a public hearing
for the purpose of receiving evidence relevant and material
to the issues raised by such objections. Any report, recom-
mendations, underlying data and reasons certified to the
Secretary by an advisory committee shall be made a part
H. R. 4475——2
bo
6
of the record of the hearing. The advisory committee shall
designate one of its members to appear and testify at any
such hearing with respect to its report and recommendations
upon request of the officer conducting the hearing or any
person adversely affected: Provided, That this shall not pre-
clude any other member of the advisory committee from
appearing and testifying at such hearing. As soon as prac-
ticable after completion of the hearing, the Secretary shall
act upon such objections and issue an order. Such order
shall be based only on substantial evidence of record at such
hearing, including any report, recommendations, underlying
data, and reasons certified to the Secretary by an advisory
- committee, and shall set forth detailed findings of fact upon
which the order is based. No such order shall take effect
prior to the ninetieth day of its publication, unless the
Secretary finds that emergency conditions exist necessitating
an earlier effective date, in which event he shall specify in
the order his findings as to such conditions.
“(f) Whenever an application is referred to an advisory
committee, the Secretary shall appoint a committee of com-
_ petent experts to review the application and to make a report
and recommendations thereon. Hach such advisory com-
mittee shall be composed of experts qualified in the subject
matter of the application and of adequately diversified pro-
fessional background selected by the National Academy of
7
Sciences: Provided, That in the event of disability or refusal
of the National Academy of Sciences to act, the Secretary
shall select such a committee. The size of the committee
shall be determined by the Secretary. Members of an ad-
visory committee shall receive as compensation for their
services a reasonable per diem, which the Secretary shall
by rules and regulations prescribe, for time actually spent
in the work of the committee, and shall in addition be re-
imbursed for their necessary traveling and subsistence ex-
penses while so serving away from their places of residence.
The members shall not be subject to any other provisions of
law regarding the appointment and compensation of em-
ployees of the United States. The Secretary shall furnish
the committee with adequate clerical and other assistance.
“(o) Any person adversely affected, and representa-
tives of the Department of Health, Education, and Welfare,
shall have the right to consult with any advisory committee
provided for in subsection (f) in connection with the appli-
cation.
“(h) Orders issued under this section, and orders
amending or repealing such orders, may be appealed by
any person adversely affected in accordance with the pro-
visions of section 505 (h): Provided, That the findings of
the Secretary shall be sustained if supported by substantial
evidence when considered on the record as a whole.
uo wa nr ano a FeF WO DBO
eo &- HF HEH we He kk Et &
om en < © es °° Ge > >) | ~~ a \ 2 a)
8
“(i) The Secretary shall promulgate regulations estab-
lishing the procedure by which orders issued under this
section may be amended or repealed, and such procedure
shall conform to the procedure provided in this section for
the promulgation of regulations, including the appointment
of advisory committees and the procedure for referring appli-
cations to such committees.
“(j) The Secretary shall promulgate regulations ex-
empting from the operation of this section chemical additives
intended solely for investigational use by experts qualified
by scientific training and experience to investigate the safety
of such chemical additives.”
Sec. 6. The Secretary of Health, Education, and Wel-
fare, by regulation, shall require the payment of such fees
for the performance of the Secretary’s functions under this
statute as will in the aggregate, in the judgment of the
Secretary, be sufficient over a reasonable term to provide,
equip, and maintain an adequate service for such function.
Src. 7. This statute shall take effect six months after
the date of its enactment.
ee ee Oe ee pe lS St ee ee
wyemce’ HR. 4475
A BILL
To protect the public health by amending the
Federal Food, Drug, and Cosmetic Act so
as to provide for the safety of chemical
additives in food.
By Mr. Drnanry
a
FEBRUARY 28, 1955
Referred to the Committee on Interstate and Foreign
Commerce
84rn CONGRESS
Ist Session
2 @
T
IN THE
OUSE OF REPRESENTATIVES
Frpsruary 28, 1955
Mr. Detanry introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To protect the public health by amending the Federal Food,
Drug, and Cosmetic Act so as to provide for the safety of
chemicals in cosmetics.
1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 That section 201 of the Federal Food, Drug, and Cosmetic
4 Act is amended by adding the following paragraph at the
5 end of said section:
6 “The term ‘cosmetic chemical’ means any substance
7 which (1) is intended for use (A) as a cosmetic or com-
8 ponent thereof, or (B) to preserve or alter any cosmetic or
9 any characteristic of any cosmetic; and (2) is not generally
I
23
25
»)
recognized, among experts qualified by scientific training
and experience to evaluate the safety of such substances, as
having been adequately tested to show that it is not poison-
ous or deleterious, or is a poisonous or deleterious substance
which is not generally recognized by such experts as having
been adequately tested to show that it is safe for use in
cosmetics.”
Src. 2. Section 301 of such Act is amended by insert-
ing “605” in subsections (d) and (j).
Suc. 3. Section 304 of such Act is amended by inserting
“605” in subsections “a” and “d’’.
Sno. 4. Section 601 of such Act is amended by changing
subsection (a) to read as follows:
“(a) If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the
conditions of use prescribed in the labeling thereof, or under
such conditions of use as are customary or usual: Provided,
That this provision shall not apply to articles containing any
coal tar or intermediate thereof which coal tar or imterme-
diate thereof alters the color of the hair, when such articles
are applied to the hair under the conditions of use prescribed
in the labeling thereof or under such conditions of use as are
customary or usual, if the Secretary by regulation finds that
such articles may be used by the public without likelihood
of harm and the label of which bears the following legend
3
conspicuously displayed thereon: ‘Caution—This product con-
tains ingredients which may cause skin irritation on certain
individuals and a preliminary test according to accompanying
directions should first be made. This product must not be
used for dyeing the eyelashes or eyebrows. It must be kept
out of the eyes and away from the areas around the eyes.
Failure to follow these instructions may result in blindness.’,
and the labeling of which bears adequate directions for such
preliminary testing. For the purposes of this paragraph and
paragraph (e), the term ‘hair dye’ shall not include eyelash
dyes or eyebrow dyes.”
Sec. 5. Section 601 is further amended by adding the
following paragraph:
“(f) If it bears or contains any cosmetic chemical, un-
less the use of such cosmetic chemical in such cosmetic has
been approved pursuant to section 605.”
Src. 6. Section 602 of such Act is amended by adding
the following paragraph:
“(e) Unless its labeling bears (1) the common or usual
name of the cosmetic chemical, and (2) in case it is fabri-
cated from two or more ingredients, the common or usual
name of each such ingredient: Provided, That to the extent
that compliance with the requirements of clause (2) of this
paragraph is impracticable, or results in deception or unfair
competition, or is not in the best interest of the consumer,
15
1
exemptions shall be established by regulations promulgated
by the Secretary.”
Sec. 7. The following section shall be added to chapter
VI of such Act:
“COSMETIC CHEMICALS
“Sec, 605. (a) No person shall mtroduce or deliver
for introduction into interstate commerce any cosmetic chem-
ical, unless the use of such cosmetie chemical has been ap-
proved pursuant to this section.
“(b) Any person may file with the Secretary an appli-
vation for the issuance of an order approving the use of a
cosmetic chemical. There shall be submitted to the Secretary
as a part of the application (1) reports of investigations
which have been made to show the acute and chronic toxicity
and other potentiality for harm of the cosmetic chemical;
(2) a statement of the composition of the cosmetic chemical;
(3) a description of methods of analysis for the quantitative
determination of the cosmetic chemical in or on cosmetics,
including animal tissues if stored therein; (4) such samples
of the cosmetic chemical as the Secretary may require; and
(5) all directions, recommendations and suggestions pro-
posed for the use of the cosmetic chemical.
“(c) The Secretary shall issue an order approving the
application within ninety days after the filing of the appli-
vation if the Secretary finds that the reports submitted to
H OO
oO
5
him pursuant to subsection (b) demonstrate that the cos-
metic chemical is not a poisonous or deleterious substance, or
if it is that it is safe for its intended use; otherwise, except
as provided in subsection (d), the Secretary shall issue an
order within said ninety days refusing to approve the
application.
“(d) Within said ninety-day period specified in sub-
section (c), the Secretary, when he deems such action
advisable or upon notification from the applicant, shall
submit the application and other data before him to an
advisory committee to be appointed pursuant to subsection
(f). Within sixty days after such referral, or within an
additional thirty days if the committee deems such addi-
tional time necessary, the committee, after independent
study of the data submitted to it by the Secretary, shall
certify to him a report and recommendations on the pro-
posal in the application, together with all underlying data
and a statement of the reasons for the recommendations.
Within thirty days after such certification, the Secretary,
after giving due consideration to all the material, including
such report and recommendations, then before him, shall
issue an order approving the application if he finds that
the cosmetic chemical is not a poisonous or deleterious sub-
stance or if it is that it is safe for its intended use; other-
H. R. 4476
2
iw)
6
wise the Secretary shall issue an order within said thirty
days refusing to approve the application. In determining
whether a cosmetic chemical is safe under subsections (c)
or (d), the Secretary shall take into account the other ways
in which the consumer may be affected by the same sub-
stance or other substances.
“(e) Within thirty days after the issuance of an order
under subsections (¢) or (d), any person adversely affected
may file objections thereto with the Secretary specifying the
reasons he deems the order objectionable and requesting
a public hearing upon such objections. After furnishing due
notice, the Secretary shall thereupon hold a public hearing
for the purpose of receiving evidence relevant and material
to the issues raised by such objections. Any report, recom-
mendations, underlying data and reasons certified to the
Secretary by an advisory committee shall be made a part of
the record of the hearing. The advisory committee shall
designate one of its members to appear and testify at any
such hearing with respect to its report and recommenda-
tions upon request of the officer conducting the hearing or
any person adversely affected: Provided, That this shall
not preclude any other member of the advisory committee
from appearing and testifying at such hearing. As soon as
practicable after completion of the hearing, the Secretary
shall act upon such objections and issue an order. Such
7
order shall be based only on substantial evidence of record
at such hearing, including any report, recommendations,
underlying data, and reasons certified to the Secretary by an
advisory committee, and shall set forth detailed findings of
fact upon which the order is based. No such order shall
take effect prior to the ninetieth day of its publication,
unless the Secretary finds that emergency conditions exist
necessitating an earlier effective date, in which event he
shall specify in the order his findings as to such conditions.
“({) Whenever an application is referred to an advisory
committee, the Secretary shall appoint a committee of com-
petent experts to review the application and to make a
report and recommendations thereon. Each such advisory
committee shall be composed of experts qualified in the
subject matter of the application and of adequately diversified
professional background selected by the National Academy
of Sciences: Provided, That in the event of disability or
refusal of the National Academy of Sciences to act, the
Secretary shall select such a committee. The size of the
committee shall be determined by the Secretary. Members
of an advisory committee shall receive as compensation for
their services a reasonable per diem, which the Secretary
shall by rules and regulations prescribe, for time actually
spent in the work of the committee, and shall in addition
be reimbursed for their necessary traveling and subsistence
oo
on
12
15
8
expenses while so serving away from their places of residence.
The members shall not be subject to any other provisions
of law regarding the appointment and compensation of
employees of the United States. The Secretary shall furnish
the committee with adequate clerical and other assistance.
“(g) Any person adversely affected, and representatives
of the Department of Health, Education, and Welfare, shall
have the right to consult with any advisory committee pro-
vided for in subsection (f) in connection with the application.
“(h) Orders issued under this section, and orders
amending or repealing such orders, may be appealed by any
person adversely affected in accordance with the provisions
of section 505 (h): Provided, That the findings of the
Secretary shall be sustained if supported by substantial evi-
dence when considered on the record as a whole.
“(i) The Secretary shall promulgate regulations estab-
lishing the procedure by which orders issued under this
section may be amended or repealed, and such procedure
shall conform to the procedure provided in this section for
the promulgation of regulations, including the appointment
of advisory committees and the procedure for referring
applications to such committees.
“(j) The Secretary shall promulgate regulations ex-
empting from the operation of this section cosmetic chemicals
intended solely for investigational use by experts qualified
9
10
9
by scientific training and experience to investigate the safety
of such cosmetic chemicals.”
Sec. 8. The Secretary of Health, Education, and Wel-
fare, by regulation, shall require the payment of such fees
for the performance of the Secretary’s functions under this
statute as will in the aggregate, in the judgment of the
Secretary, be sufficient over a reasonable term to provide,
equip, and maintain an adequate service for such function.
Src. 9. This statute shall take effect six months after
the date of its enactment.
“irs 6A R. 4476
A BILL
To protect the public health by amending the
Federal Food, Drug, and Cosmetic Act so
as to provide for the safety of chemicals in
cosmetics.
By Mr. Drtanry
FEBRUARY 28, 1955
Referred to the Committee on Interstate and Foreign
Commerce
“nsec AL, R, 7798
ist Session
e @
IN THE HOUSE OF REPRESENTATIVES
May 28, 1957
Mr. Deanery introduced the following bill; which was referred to the Com-
mittee on Interstate and Foreign Commerce
A BILL
To protect the public health by amending the Federal Food,
10
Drug, and Cosmetic Act so as to provide for the safety of
chemical additives in food.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
That section 201 of the Federal Food, Drug, and Cosmetic
Act is amended by the addition of the following paragraph:
“(s) The term ‘chemical additive’ means any substance
(including products resulting from changes in such sub-
stance after use) which (1) is intended for use (A) asa
food, or (B) to preserve or alter any food or any character-
istic of any food, including any radioactive material intended
for any such use; or (C) for any other purpose in producing,
vVi-O
o oa nna Fe» WO YH -
jfk or tet
ye WO Oo - OC
15
2
processing, packing, transporting, wrapping, or holding food
if such use is likely to result in the contamination of food,
including any radioactive material intended for any such use,
but shall not include pesticide chemicals used in the produc-
tion, storage, or transportation of raw agricultural commodi-
ties, as defined in section 201 (q) of this Act; and (2)
is not generally recognized, among experts qualified by scien-
tific training and experience to evaluate the safety of chemical
additives, as having been adequately tested to show that it is
not poisonous or deleterious, or is a poisonous or deleterious
substance which is not generally recognized among such
experts as having been adequately tested to show that it is
safe for its intended use.”
Src. 2. Section 301 of the Federal Food, Drug, and
Cosmetic Act is amended by changing ‘404 or 505” in
subsection (d) to “404, 409, or 505”; and “404, 505, 506,
507, or 704” in subsection (j) to “404, 409, 505, 506,
507, or 704”.
Src. 3. Section 304 of such Act is amended by changing
“404 or 505” in subsections (a) and (d) to “404, 409, or
505”.
Sec. 4. Section 402 (a) of such Act is amended by
changing the period at the end to a semicolon and adding:
“ce
or (7) if it is, or bears or contains, a chemical additive,
[o>
eo eo ss
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
3
unless the use of such chemical additive has been approved
pursuant to section 409.”
Sec. 5. The following section shall be added to chapter
IV of such Act:
“CHEMICAL ADDITIVES
“Sec. 409. (a) No person shall introduce or deliver for
introduction into interstate commerce any chemical additive,
unless the use of such chemical additive has been approved
pursuant to this section.
“(b) Any person may file with the Secretary an appli-
cation for the issuance of an order approving the use of a
chemical additive. There shall be submitted to the Secretary
with the application (1) a statement of the intended use of
the chemical additive and demonstrating that such employ-
ment of the chemical additive will serve a purpose which will
be useful to the consuming public; (2) reports of investiga-
tions which have been made to determine the acute and
chronic toxicity, carcinogenicity, and other potentiality for
harm of the chemical additive; (3) a statement of the com-
position of the chemical additive; (4) a description of
methods of analysis for the quantitative determination of the
chemical additive, and its reduction products, in or on food;
(5) such samples of the chemical additive as the Secretary
may require; (6) all directions, recommendations, and sug-
25
4
gestions proposed for the use of the chemical additive; and
(7) if the chemical additive is a poisonous or deleterious
substance, reports of investigations which have been made
to show the quantities of the chemical additive remaining in
or on the food and that it is required for its intended use.
“(c) The Secretary shall issue an order approving the
application within ninety days after the filing of the applica-
tion if the Secretary finds that the reports submitted to him
pursuant to subsection (b) demonstrate (1) that the chemi-
cal additive is not a poisonous or deleterious substance or if
it is that it is safe and required for its intended use, and (2)
that the intended use of the chemical additive will serve a
purpose which will be useful to the consuming public; other-
wise, except as provided in subsection (d), the Secretary
shall issue an order within said ninety days refusing to
approve the application.
“(d) Within said ninety-day period specified in sub-
section (¢), the Secretary, when he deems such action ad-
visable or upon notification from the applicant, shall submit
the application and other data before him to an advisory com-
mittee to be appointed pursuant to subsection (f). Within
sixty days after such referral, or within an additional thirty
days if the committee deems such additional time necessary,
the committee, after independent study of the data submitted
to it by the Secretary, shall certify to him a report and
5
recommendations on the proposal in the application, together
with all underlying data and a statement of the reasons for
the recommendations. Within thirty days after such cer-
tification, the Secretary, after giving due consideration to all
the material, including such report and recommendations.
then before him, shall issue an order approving the applica-
tion if he finds that the chemical additive is not a poisonous
or deleterious substance or if it is that it is safe and required
for its intended use, and that its intended use will serve a
purpose which will be useful to the consuming public; other-
wise the Secretary shall issue an order within said thirty
days refusing to approve the application. In determining
whether a chemical additive is safe under subsection (¢) or
(d), the Secretary shall take ito account the other ways in
which the consumer may be affected by the same substance
or other substances, including any hazard to the health of
the consumer from food which is yielded by, or derived from,
any animal or plant into which such chemical additive has
been introduced by feeding or otherwise. The Secretary
shall not approve for use in food any chemical additive
found to induce cancer in man, or, after tests, found to induce
cancer in animals,
“(e) Within thirty days after the issuance of an order
under subsection (c) or (d), any person adversely affected
If. R. 7798
9
_
i)
f)
may file objections thereto with the Secretary specifying the
reasons he deems the order objectionable and requesting a
public hearing upon such objections. After furnishing due
notice, the Secretary shall thereupon hold a public hearing
for the purpose of receiving evidence relevant and material
to the issues raised by such objections. Any report, recom-
mendations, underlying data and reasons certified to the
Secretary by an advisory committee shall be made a part
of the record of the hearing. The advisory committee shall
designate one of its members to appear and testify at any
such hearing with respect to its report and recommendations
upon request of the officer conducting the hearmg or any
person adversely affected: Provided, That this shall not pre-
clude any other member of the advisory committee from
appearing and testifying at such hearing. As soon as prac-
ticable after completion of the hearings, the Secretary shall
act upon such objections and issue an order. Such order
shall be based only on substantial evidence of record at such
hearing, including any report, recommendations, underlying
data, and reasons certified to the Secretary by an advisory
committee, and shall set forth detailed findings of fact upon
which the order is based. No such order shall take effect
prior to the ninetieth day of its publication, unless the
Secretary finds that emergency conditions exist necessitating
7
an earlier effective date, in which event he shall specify in
the order his findings as to such conditions.
“(f) Whenever an application is referred to an advisory
committee, the Secretary shall appoint a committee of com-
petent experts to review the application and to make a report
and recommendations thereon. Hach such advisory com-
mittee shall be composed of experts qualified in the subject
inatter of the application and of adequately diversified pro-
fessional background selected by the National Academy of
Sciences: Provided, That in the event of disability or refusal
of the National Academy of Sciences to act, the Secretary
shall select such a committee. The size of the committee
shall be determined by the Secretary. Members of an
advisory committee shall receive as compensation for their
services a reasonable per diem, which the Secretary shall
by rules and regulations prescribe, for time actually spent
in the work of the committee, and shall in addition be
reimbursed for their necessary traveling and subsistence ex-
penses while so serving away from their places of residence.
The members shall not be subject to any other provisions
of law regarding the appointment and compensation of em-
ployees of the United States. The Seerctary shall furnish
the committee with adequate clerical and other assistance.
“e
(g) Any person adversely affected, and representa-
8
1 tives of the Department of Health, Education, and Welfare,
shall have the right to consult with any advisory commit-
2
3 tee provided for in subsection (f) in connection with the
4 application.
5 “(h) Orders issued under this section, and orders
6 amending or repealing such orders, may be appealed by
7 any person adversely affected in accordance with the pro-
s visions of section 505 (h): Provided, That the findings of
9 the Secretary shall be sustained if supported by substantial
10 evidence when considered on the record as a whole.
11 “(i) The Secretary shall promulgate regulations es-
12 tablishing the procedure by which orders issued under this
13 section may be amended or repealed, and such procedure
14 shall conform to the procedure provided in this section for
15 the promulgation of regulations, including the appoimtment
16 of advisory committees and the procedure for referring
17 applications to such committees.
18 “(j) The Secretary shall promulgate regulations ex-
19 empting from the operation of this section chemical additives
20 intended solely for investigational use by experts qualified
21 by scientific training and experience to investigate the safety
22 of such chemical additives.”
23 Src. 6. The Secretary of Health, Education, and Wel-
24 fare, by regulation, shall require the payment of such fees
25 for the performance of the Secretary’s functions under this
ono m wo no Ee
9
statute as will in the aggregate, in the judgment of the
Secretary, be sufficient over a reasonable term to provide,
equip, and maintain an adequate service for such function.
SEc. 7. This statute shall take effect six months after
the date of its enactment,
85tH CONGRESS
ist Session e e 7 7198
A BILL
To protect the public health by amending the
Federal Food, Drug, and Cosmetic Act so
as to provide for the safety of chemical
additives in fuod.
By Mr. Detanry
May 28, 1957
Referred to the Committee on Interstate and Foreign
Commerce
CC BY-NC-SA 4.0