|
CHAPTER IV - FOOD
DEFINITIONS
AND STANDARDS FOR FOOD
SEC.
401 [341]. Whenever in the judgment of the Secretary
such action will promote honesty and fair dealing in the interest
of consumers, he shall promulgate regulations fixing and establishing
for any food, under its common or usual name so far as practicable,
a reasonable definition and standard of identity, a reasonable
standard of quality, and/or reasonable standards of fill of
container: Provided, That no definition and standard
of identity and no standard of quality shall be established
for fresh or dried fruits, fresh or dried vegetables, or butter,
except that definitions and standards of identity may be established
far avocados, cantaloupes, citrus fruits, and melons.
In prescribing any standard of fill of container, the
Secretary shall give due consideration to the natural shrinkage
in storage and in transit of fresh natural food and to need
for the necessary packing and protective material.
In the prescribing of any standard of quality for any
canned fruit or canned vegetable, consideration shall be given
and due allowance made for the differing characteristics of
the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any
food or class of food in which optional ingredients are permitted,
the Secretary shall, for the purpose of promoting honesty
and fair dealing in the interest of consumers, designate the
optional ingredients which shall be named on the label.
Any definition and standard of identity prescribed
by the Secretary for avocados, cantaloupes, citrus fruits,
or melons shall relate only to maturity and to the effects
of freezing.
ADULTERATED
FOOD
SEC.
402 [342]. A
food shall be deemed to be adulterated
(a)
(1) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance
is not an added substance such food shall not be considered
adulterated under this clause if the quantity of such substance
in such food does not ordinarily render it injurious to health;
or
(2)
12(A) if it bears or contains any added
poisonous or added deleterious substance (other than one which
is (i) a pesticide chemical in or on a raw agricultural commodity;
(ii) a food additive; (iii) a color additive; or (iv) a new
animal drug) which is unsafe within the meaning of section
406, or (B) if it is a raw agricultural commodity and it bears
or contains a pesticide chemical which is unsafe within the
meaning of section 408(a); or (C) if it is, or it bears or
contains, any food additive which is unsafe within the meaning
of section 409: Provided, That where a pesticide chemical
has been used in or on a raw, agricultural commodity in conformity
with an exemption granted or a tolerance prescribed under
section 408 .and such raw agricultural commodity has been
subjected to processing such as canning, cooking, freezing,
dehydrating, or milling, the residue of such pesticide chemical
remaining in or on such processed food shall, notwithstanding
the provisions of sections 406 and 409, not be deemed unsafe
if such residue in or on the raw agricultural commodity
has been removed to the extent possible in good manufacturing
practice and the concentration of such residue in the, processed
food when ready to eat is not greater than the tolerance prescribed
for the raw agricultural commodity; or (D) if it is, or it
bears or contains, a new animal drug (or conversion product
thereof) which is unsafe within the meaning of section 512;
or
(3)
if it consists in whole or in part of any filthv, putrid,
or decomposed substance, or if it is otherwise unfit for food;
or (4) if it has been prepared, packed, or held under insanitarv
conditions whereby it may have become contaminated with filth,
or whereby it may have been rendered injurious to health;
or (5) if it is, in whole or in part, the product of a diseased
animal or of an animal which has died otherwise than by slaughter;
or (6) if its container is composed, in whole or in part,
of any poisonous or deleterious substance which may render
the contents injurious to health; or (7) if it has been intentionally
subjected to radiation, unless the use of the radiation was
in conformity with a regulation or exemption in effect pursuant
to section 409.
(b)
(1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has
been substituted wholly or in part therefor; or (3) if damage
or inferiority has been concealed in any manner; or (4) if
any substance has been added thereto or mixed or packed therewith
so as to increase its bulk or weight, or reduce its quality
or strength, or make it appear better or of greater value
than it is.
(c)
If it is, or it bears or contains, a color additive which
is unsafe within the meaning of section 706(a).
(d)
13If it is confectionery, and -
(1) has partially or completelv imbedded therein
any nonnutritive object: Provided, That this clause
shall not apply in the case of any nonnutritive object if,
in the judgment of the Secretary as provided by regulations,
such object is of practical functional value to the confectionery
product and would not render the product injurious or hazardous
to health;
(2) bears or contains any alcohol other than
alcohol not in excess of one-half of 1 per centum by volume
derived solely from the use of flavoring extracts; or
(3) bears or contains any nonnutritive substance: Provided, That
this clause shall not apply to a safe nonnutritive substance
which is in or on confectionery by reason of its use for
some practical functional purpose in the manufacture, packaging,
or storage of such confectionery if the use of the substance
does not promote deception of the consumer or otherwise
result in adulteration or misbranding in violation of any
provision of this Act: And provided further, That
the Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this clause, issue
regulations allowing or prohibiting the use of particular
nonnutritive substances.
(e) If it is oleomargarine or margarine or butter
and any of the raw material used therein consisted in whole
or in part of any filthy, putrid, or decomposed substance,
or such oleomargarine or margarine or butter is otherwise
unfit for food.
MISBRANDED FOOD
SEC. 403 [343]. A food shall be deemed to be misbranded -
(a) 13aIf (1) its labeling is false or misleading in
any particular, or (2) in the case of a food to which section
411 applies its advertising, is false or misleading in a material
respect or its labeling is in violation of sec. 411 (b) (2).
(b) If it is offered for sale under the name
of another food.
(c) If it is an imitation of another food, unless
its label bears, in type of uniform size and prominence, the
word "imitation" and, immediately thereafter, the
name of the food imitated.
(d) If its container is so made, formed, or
filled as to be misleading.
(e)
If in package form unless it bears a label containing (1)
the name and place of business of the manufacturer, packer,
or distributor; and (2) an accurate statement of the quantity
of the contents in terms of weight, measure, or numerical
count: Provided, That under clause (2) of this paragraph
reasonable variations shall be permitted, and exemptions as
to small packages shall be established, by regulations prescribed
by the Secretary.
(f) If any word, statement, or other information
required by or under authority of this Act to appear on the
label or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as
to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(g) If it purports to be or is represented as
a food for which a definition and standard of identity has
been prescribed by regulations as provided by section 401,
unless (1) it conforms to such definition and standard, and
(2) its label bears the name of the food specified in the
definition and standard, and, insofar as may be required by
such regulations, the common names of optional ingredients
(other than spices, flavoring, and coloring) present in such
food.
(h) If it purports to be or is represented as
(1) a food for which a standard of quality has
been prescribed by regulations as provided by section 401,
and its quality falls below such standard, unless its label
bears, in such manner and form as such regulations specify,
a statement that it falls below such standard; or
(2) a food for which a standard or standards
of fill of container have been prescribed by regulations
as provided by section 401, and it falls below the standard
of fill of container applicable thereto, unless its label
bears, in such manner and form as such regulations specify,
a statement that it falls below such standard.
(i) If it is not subject to the provisions of
paragraph (g) of this section unless its label bears (1) the
common or usual name of the food, if any there be, and (2)
in case it is fabricated from two or more ingredients, the
common or usual name of each such ingredient; except that
spices, flavorings, and colorings, other than those sold as
such, may be designated as spices, flavorings, and colorings
without naming each: 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, exemptions shall be established by regulations
promulgated by the Secretary.
(j) If it purports to be or is represented for
special dietary uses, unless its label bears such information
concerning its vitamin, mineral, and other dietary properties
as the Secretary determines to be, and by regulations prescribes
as, necessary in order fully to inform purchasers as to its
value for such uses.
(k) If it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative, unless it bears
labeling stating that fact: Provided, That to the extent
that compliance with the requirements of this paragraph is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary. The provisions of this paragraph and paragraphs
(g) and (i) with respect to artificial coloring shall not
apply in the case of butter, cheese, or ice cream.
The provisions of this paragraph with respect to chemical
preservatives shall not apply to a pesticide chemical when
used in or on a raw agricultural commodity which is the produce
of the soil.
(1) If it is a raw agricultural commodity which
is the produce of the soil, bearing or containing a pesticide
chemical applied after harvest, unless the shipping container
of such commodity bears labeling which declares the presence
of such chemical in or on such commodity and the common or
usual name and the function of such chemical: Provided,
however, That no such declaration shall be required
while such commodity, having been removed from the shipping
container, is being held or displayed for sale at retail out
of such container in accordance with the custom of the trade.
(m)
If it is a color additive, unless its packaging and labeling
are in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in
regulations issued under section 706.
(n) 13bIf its packaging or labeling is in violation
of an applicable regulation issued pursuant to section 3 or
4 of the Poison Prevention Packaging Act of 1970.
EMERGENCY PERMIT CONTROL
SEC. 404 [344]. (a) Whenever the Secretary finds
after investigation that the distribution in interstate commerce
of any class of food may, by reason of contamination with
micro-organisms during the manufacture, processing, or packing
thereof in any locality, be injurious to health, and that
such injurious nature cannot be adequately determined after
such articles have entered interstate commerce, he then, and
in such case only, shall promulgate regulations providing
for the issuance, to manufacturers, processors, or packers
of such class of food in such locality, of permits to which
shall be attached such conditions governing the manufacture,
processing, or packing of such class of food, for such temporary
period of time, as may be necessary to protect the public
health; and after the effective date of such regulations,
and during such temporary period, no person shall introduce
or deliver for introduction into interstate commerce any such
food manufactured, processed, or packed by any such manufacturer;
processor, or packer unless such manufacturer, processor,
or packer holds a permit issued by the Secretary as provided
by such regulations.
(b) The Secretary is authorized to suspend immediately
upon notice any permit issued under authority of this section
if it is found that any of the conditions of the permit have
been violated. The holder of a permit so suspended shall
be privileged at any time to apply for the reinstatement of
such permit, and the Secretary shall, immediately after prompt
hearing and an inspection of the establishment, reinstate
such permit if it is found that adequate measures have been
taken to comply with and maintain the conditions of the permit,
as originally issued or as amended.
(c) Any officer or employee duly designated
by the Secretary shall have access to any factory or establishment,
the operator of which holds a permit from the Secretary, for
the purpose of ascertaining whether or not the conditions
of the permit are being complied with, and denial of access
for such inspection shall be ground for suspension of the
permit until such access is freely given by the operator.
REGULATIONS MAKING EXEMPTIONS
SEC. 405 [345]. The Secretary shall promulgate regulations exempting from any
labeling requirement of this Act (1) small open containers
of fresh fruits and fresh vegetables and (2) food which is
in accordance with the practice of the trade, to be processed,
labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on
condition that such food is not adulterated or misbranded
under the provisions of this Act upon removal from such processing,
labeling, or repacking establishment.
TOLERANCES FOR POISONOUS
INGREDIENTS IN FOOD
SEC. 406 (346]. Any poisonous or deleterious substance added to any food, except
where such substance is required in the production thereof
or cannot be avoided by good manufacturing. practice shall
be deemed to be unsafe for purposes of the application of
clause (2) (A) of section 402(a); but when such substance
is so required or cannot be so avoided, the Secretary shall
promulgate regulations limiting the quantity therein or thereon
to such extent as he finds necessary for the protection of
public health, and any quantity exceeding the limits so fixed
shall also be deemed to be unsafe for purposes of the application
of clause (2) (A) of section 402(a). While such a regulation is in effect limiting the quantity
of any such substance in the case of any food, such food shall
not, by reason of bearing or containing any added amount of
such substance, be considered to be adulterated within the
meaning of clause (1) of section 402(a). In determining the
quantity of.such added substance to be tolerated in or on
different articles of food the Secretary shall take into account
the extent to which the use of such substance is required
or cannot be avoided in the production of each such article,
and the other ways in which the consumer may be affected by
the same or other poisonous or deleterious substances.
OLEOMARGARINE OR MARGARINE
[Public Law 459-81st Congress-March 16, 1950
(64 Stat. 20), amended section 15 of the Federal Trade Commission
Act, As Amended, by adding at the end thereof the following
new subsection: "(f) For the purposes of this section
and section 407 of the Federal Food, Drug, and Cosmetic Act,
As Amended, the term `oleomargarine' or `margarine' includes-(1)
all substances, mixtures, and compounds known as oleomargarine
or. margarine; (2) all substances, mixtures, and compounds
which have a consistence similar to that of butter and which
contain any edible oils or fats other than milk fat if made
in imitation or semblance of butter."
[In repealing section 2301 of the Internal Revenue
Code (relating to the tax on oleomargarine) Public Law 459
declared, in part: "The Congress hereby finds and declares
that the sale, or the serving in public eating places, of
colored oleomargarine or colored margarine without clear identification
as such or which is otherwise adulterated or misbranded within
the meaning of the Federal Food, Drug, and Cosmetic Act depresses
the market in interstate commerce for butter and for oleomargarine
or margarine clearly identified and neither adulterated nor
misbranded, and constitutes a burden on interstate commerce
in such articles. Such burden exists, irrespective of whether
such oleomargarine or margarine originates from an interstate
source or from the State in which it is sold."
["Nothing in this Act shall be construed
as authorizing the possession, sale, or serving of colored
oleomargarine or colored margarine in any State or Territory
in contravention of the laws of such State or Territory."]
SEC. 407 [347]. (a) Colored oleomargarine or
colored margarine which is sold in the same State or Territory
in which it is produced shall be subject in the same manner
and to the same extent to the provisions of this Act as if
it had been introduced in interstate commerce.
(b)
No person shall sell, or offer for sale, colored oleomargarine
or colored margarine unless –
(1)
such oleomargarine or margarine is packaged,
(2)
the net weight of the contents of any package sold in a
retail establishment is one pound or less,
(3) there appears on the label of the package
(A) the word "oleomargarine" or "margarine"
in type or lettering at least as large as any other type
or lettering on such label, and (B) a full and accurate
statement of all the ingredients contained in such oleomargarine,
or margarine, and
(4) each part of the contents of the package
is contained in a wrapper which bears the word "oleomargarine"
or "margarine" in type or lettering not smaller
than 20-point type.
The
requirements of this subsection shall be in addition to and
not in lieu of any of the other requirements of this Act.
(c) No person shall possess in a form ready
for serving colored oleomargarine or colored margarine at
a public eating place unless a notice that oleomargarine or
margarine is served is displayed prominently and conspicuously
in such place and in such manner as to render it likely to
be read and understood by the ordinary individual being served
in such eating place or is printed or is otherwise set forth
on the menu in type or lettering not smaller than that normally
used to designate the serving of other food items. No person
shall serve colored oleomargarine or colored margarine at
a public eating place, whether or not any charge is made therefor,
unless (1) each separate serving bears or is accompanied by
labeling identifying it as oleomargarine or margarine, or
(2) each separate serving thereof is triangular in shape.
(d) Colored oleomargarine or colored margarine
when served with meals at a public eating place shall at the
time of such service be exempt from the labeling requirements
of section 403 of this title (except (a) and (f)) if it complies
with the requirements of subsection (b) of this section.
(e) For the purpose of this section colored
oleomargarine or colored margarine is oleomargarine or margarine
having a tint or shade containing more than one and six-tenths
degrees of yellow, or of yellow and red collectively, but
with an excess of yellow over red, measured in terms of Lovibond
tintometer scale or its equivalent.
TOLERANCES FOR PESTICIDE
CHEMICALS IN OR ON RAW
AGRICULTURAL COMMODITIES
SEC. 408 [346a]. (a) Any poisonous or deleterious
pesticide chemical, or any pesticide chemical which is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety of pesticide
chemicals, as safe for use, added to a raw agricultural commodity,
shall be deemed unsafe for the purposes of the application
of clause (2) of section 402(a) unless
(1)
a tolerance for such pesticide chemical in or on the raw
agricultural commodity has been prescribed by the Secretary
of Health, Education, and Welfare under this section and
the quantity of such pesticide chemical in or on the raw
agricultural commodity is within the limits of the tolerance
so prescribed; or
(2) with respect to use in or on such raw agricultural
commodity, the pesticide chemical has been exempted from
the requirement of a tolerance by the Secretary under this
section.
While a tolerance or exemption from tolerance is in effect for a pesticide
chemical with respect to any raw agricultural commodity, such
raw agricultural commodity shall not, by reason of bearing
or containing any added amount of such pesticide chemical,
be considered to be adulterated within the meaning of clause
(1) of section 402(a).
(b)
The Secretary shall promulgate regulations establishing tolerances
with respect to the use in or on raw agricultural commodities
of poisonous or deleterious pesticide chemicals and of pesticide
chemicals which are not generally recognized, among experts
qualified by scientific training and experience to evaluate
the safety of pesticide chemicals, as safe for use, to the
extent necessary to protect the public health. In establishing
any such regulation, the Secretary shall give appropriate
consideration, among other relevant factors, (1) to the necessity
for the production of an adequate, wholesome, and economical
food supplv; (2) to the other ways in which the consumer may
be affected by the same pesticide chemical or by other related
substances that are poisonous or deleterious; and (3) to the
opinion of the Secretary of Agriculture as submitted with
a certification of usefulness under subsection (1) of this
section. Such regulations shall be promulgated in the manner
prescribed in subsection (d) and (e) of this section. In carrying
out the provisions of this section relating to the establishment
of tolerances, the Secretary may establish the tolerance applicable
with respect to the use of any pesticide chemical in or on
any raw agricultural commodity at zero level if the scientific
data before the Secretary does not justify the establishment
of a greater tolerance.
(c) The Secretary shall promulgate regulations
exempting any pesticide chemical from the necessity of a tolerance
with respect to use in or on any or all raw agricultural commodities
when such a tolerance is not necessary to protect the public
health. Such regulations shall be promulgated in the manner
prescribed in subsection (d) or (e) of this section.
(d) (1) Any person who has registered, or who
has submitted an application for the registration of, an economic
poison under the Federal Insecticide, Fungicide, and Rodenticide
Act may file with the Secretary of Health, Education, and
Welfare, a petition proposing the issuance of a regulation
establishing a tolerance for a pesticide chemical which constitutes,
or is an ingredient of such economic poison, or exempting
the pesticide chemical from the requirement of a tolerance.
The petition shall contain data showing
(A) the name, chemical identity, and composition of the pesticide chemical;
(B) the amount, frequency, and time of application of the pesticide chemical;
(C)
full reports of investigations made with respect to the
safety of the pesticide chemical;
(D) the results of tests on the amount of residue remaining, including
a description of the analytical methods used;
(E) practicable methods for removing residue which exceeds any proposed
tolerance;
(F) proposed tolerances for the pesticide chemical if tolerances are proposed;
and
(G) reasonable grounds in support of the petition.
Samples of the pesticide chemical shall be furnished to the Secretary
upon request. Notice of the filing of such petition shall
be published in general terms by the Secretary within thirty
days after filing. Such notice shall include the analytical
methods available for the determination of the. residue of
the pesticide chemical for which a tolerance or exemption
is proposed.
(2) Within ninety days after a certification
of usefulness by the Secretary of Agriculture under subsection
(1) with respect to the pesticide chemical named in the petition,
the Secretary of Health, Education, and Welfare shall, after
giving due consideration to the data submitted in the petition
or otherwise before him, by order make public a regulation
–
(A) establishing a tolerance for the pesticide
chemical named in the petition for the purposes for which
it is so certified as useful, or
(B) exempting the pesticide chemical from the
necessity of a tolerance for such purposes,
unless within such ninety-day period the person filing the petition requests
that the petition be referred to an advisory committee or
the Secretary within such period otherwise deems such referral
necessary, in either of which events the provisions of paragraph
(3) of this subsection shall apply in lieu hereof.
(3) In the event that the person filing the
petition requests, within ninety days after a certification
of usefulness by the Secretary of Agriculture under subsection
(1), with respect to the pesticide chemical named in the petition,
that the petition be referred to an advisory committee, or
in the event the Secretary of Health, Education, and Welfare
within such period otherwise deems such referral necessary,
the Secretary of Health, Education, and Welfare shall forthwith
submit the petition and other data before him to an advisory
committee to be appointed in accordance with subsection
(g) of this section. As soon as practicable after such referral, but not
later than sixty days thereafter, unless extended as hereinafter
provided, the committee shall, after independent study of
the data submitted to it by the Secretary and other data before
it, certify to the Secretary a report and recommendations
on the proposal in the petition to the Secretary, together
with all underlying data and a statement of the reasons or
basis for the recommendations. The sixty-day period provided
for herein may be extended by the advisory committee for an
additional thirty days if the advisory committee deems this
necessary. Within thirty days after such certification, the
Secretary shall, after giving due consideration to all data
then before him, including such report, recommendations, underlying
data, and statement, by order make public a regulation –
(A) establishing a tolerance for the pesticide chemical named in the petition
for the purposes for which it is so certified as useful;
or
(B)
exempting the pesticide chemical from the necessity of a
tolerance for such purposes.
(4) The regulations published under paragraph
(2) or (3) of this subsection will be effective upon publication.
(5) Within thirty days after publication, any
person adversely affected by a regulation published pursuant
to paragraph (2) or (3) of this subsection, or pursuant to
subsection (e), may file objections thereto with the Secretary,
specifying with particularity the provisions of the regulation
deemed objectionable, stating reasonable grounds therefor,
and requesting a public hearing upon such objections. A copy
of the objections filed by a person other than the petitioner
shall be served on the petitioner, if the regulation was issued
pursuant to a petition. The petitioner shall have two weeks
to make a written reply to the objections. The Secretary shall
thereupon, after due notice, hold such public hearing for
the purpose of receiving evidence relevant and material to
the issues raised by such objections. Any report, recommendations,
underlying data, and reasons certified to the Secretary by
an advisory committee shall be made a part of the record of
the hearing, if relevant and material, subject to the provisions
of section 7(c) of the Administrative Procedure Act (5 U.S.C.,
sec. 1006(c)). The National Academy of Sciences shall designate
a member of the advisory committee to appear and testify at
any such hearing with respect to the report and recommendations
of such committee upon request of the Secretary, the petitioner,
or the officer conducting the hearing: 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 by order make public a
regulation. Such regulation 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 regulation is based.
No such order shall take effect prior to the ninetieth day
after its publication, unless the Secretary finds that emergency
conditions exist necessitating an earlier effective date,
in which event the Secretary shall specify in the order his
findings as to such conditions.
(e) The Secretary may at any time, upon his
own initiative or upon the request of any interested person,
propose the issuance of a regulation establishing a tolerance
for a pesticide chemical or exempting it from the necessity
of a tolerance. Thirty days after publication of such a proposal,
the Secretary may by order publish a regulation based upon
the proposal which shall become effective upon publication
unless within such thirty-day period a person who has registered,
or who has submitted an application for the registration of,
an economic poison under the Federal Insecticide, Fungicide,
and Rodenticide Act containing the pesticide chemical named
in the proposal, requests that the proposal be referred to
an advisory committee. In the event of such a request, the
Secretary shall forthwith submit the proposal and other relevant
data before him to an advisory committee to be appointed in
accordance with subsection (g) of this section. As soon as
practicable after such referral, but not later than sixty
days thereafter, unless extended as hereinafter provided,
the committee shall, after independent study of the data submitted
to it by the Secretary and other data before it, certify to
the Secretary a report and recommendations on the proposal
together with all underlying data and a statement of the reasons
or basis for the recommendations. The sixty-day period provided
for herein may be extended by the advisory committee for an
additional thirty days if the advisory committee deems this
necessary. Within thirty days after such certification, the
Secretary may, after giving due consideration to all data
before him, including such report, recommendations, underlying
data and statement, by order publish a regulation establishing
a tolerance for the pesticide chemical named in the proposal
or exempting it from the necessity of a tolerance which shall
become effective upon publication. Regulations issued under
this subsection shall upon publication be subject to paragraph
(5) of subsection (d).
(f) All data submitted to the Secretary or to
an advisory committee in support of a petition under this
section shall be considered confidential by the Secretary
and by such advisory committee until publication of a regulation
under paragraph (2) or (3) of subsection (d) of this section.
Until such publication. such data shall not be revealed to
any person other than those authorized by the Secretarv or
by an advisorv committee in the carrying out of their official
duties under this section.
(g) Whenever the referral of a petition or proposal
to an advisory committee is requested under this section,
or the Secretary otherwise deems such referral necessary,
the Secretary shall forthwith appoint a committee of competent
experts to review the petition or proposal and to make a report
and recommendations thereon. Each such advisory committee
shall be composed of experts, qualified in the subject matter
of the petition and of adequately diversified professional
background selected by the National Academy of Sciences and
shall include one or more representatives from land-grant
colleges. The size of the committee shall be determined by
the Secretary. Members of an advisory committee shall receive
compensation and travel expenses in accordance with subsection
(b) (5) (D) of section 706.14
[which the Secretary shall by rules and regulations prescribe.]15
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, and shall by
rules and regulations prescribe the procedures to be followed
by the committee.
(h) A person who has filed a petition or who
has requested the referral of a proposal to an advisory committee
in accordance with the provision of this section, as well
as representatives of the Department of Health, Education,
and Welfare, shall have the right to consult with any advisory
committee provided for in subsection (g) in connection with
the petition or proposal.
(i) (1) In a case of actual controversy as to
the validity of any order under subsection (d)(5), (e), or
(1) any person who will be adversely affected by such order
may obtain judicial review by filing in the United States
Court of Appeals for the circuit wherein such person resides
or has his principal place of business, or in the United States
Court of Appeals for the District of Columbia Circuit, within
60 days after entry of such order, a petition praying that
the order be set aside in whole or in part.
(2)
In the case of a petition with respect to an order under subsection
(d) (5) or (e), a copy of the petition shall be forthwith
transmitted by the clerk of the court to the Secretary, or
any officer designated by him for that purpose, and thereupon
the Secretary shall file in the court the record of the proceedings
on which he based his order, as provided in section 2112 of
title 28, United States Code. Upon the filing of such petition,
the court shall have exclusive jurisdiction to affirm or set
aside the order complained of in whole or in part. The findings
of the Secretary with respect to questions of fact shall be
sustained if supported by substantial evidence when considered
on the record as a whole, including any report and recommendation
of an advisory committee.
(3) In the case of a petition with respect to
an order under subsection (1), a copy of the petition shall
be forthwith transmitted by the clerk of the court to the
Secretary of Agriculture, or any officer designated by him
for that purpose, and thereupon the Secretary shall file in
the court the record of the proceedings on which he based
his order, as provided in section 2112 of title 28, United
States Code. Upon the filing of such petition, the court shall
have exclusive jurisdiction to affirm or set aside the order
complained of in whole or in part. The findings of the Secretary
with respect to questions of fact shall be sustained if supported
by substantial evidence when considered on the record as a
whole.
(4) If application is made to the court for
leave to adduce additional evidence, the court may order such
additional evidence to be taken before the Secretary of Health,
Education, and Welfare or the Secretary of Agriculture, as
the case may be, and to be adduced upon the hearing in such
manner and upon such terms and conditions as to the court
may seem proper, if such evidence is material and there were
reasonable grounds for failure to adduce such evidence in
the proceedings below. The Secretary of Health, Education,
and Welfare or the Secretary of Agriculture, as the case may
be, may modify his findings as to the facts and order by reason
of the additional evidence so taken, and shall file with the
court such modified findings and order.
(5) The judgment of the court affirming or setting
aside, in whole or in part, any order under this section shall
be final, subject to review by the Supreme Court of the United
States upon certiorari or certification as provided in section
1254 of title 28 of the United States Code. The commencement
of proceedings under this section shall not, unless specifically
ordered by the court to the contrary, operate as a stay of
an order. The court shall advance on the docket and expedite
the disposition of all causes filed therein pursuant to this
section.
(j) The Secretary may, upon the request of any
person who has obtained an experimental .permit for a pesticide
chemical under the Federal Insecticide, Fungicide, and Rodenticide
Act or upon his own initiative, establish a temporary tolerance
for the pesticide chemical for the uses covered by the permit
whenever in his judgment such action is deemed necessary to
protect the public health, or may temporarily exempt such
pesticide chemical from a tolerance. In establishing such
a tolerance, the Secretary shall give due regard to the necessity
for experimental work in developing an adequate, wholesome,
and economical food supply and to the limited hazard to the
public health involved in such work when conducted in accordance
with applicable regulations under the Federal Insecticide,
Fungicide, and Rodenticide Act.
(k) Regulations affecting pesticide chemicals
in or on raw agricultural commodities which are promulgated
under the authority of section 406(a) upon the basis of public
hearings instituted before January 1, 1953, in accordance
with section 701(e), shall be deemed to be regulations under
this section and shall be subject to amendment or repeal as
provided in subsection (m).
(l) The Secretary of Agriculture, upon request
of any person who has registered, or who has submitted an
application for the registration of, an economic poison under
the Federal Insecticide, Fungicide, and Rodenticide Act, and
whose request is accompanied by a copy of a petition filed
by such person under subsection (d) (1) with respect to a
pesticide chemical which constitutes, or is an ingredient
of, such economic poison, shall, within thirty days or within
sixty days if upon notice prior to the termination of such
thirty days the Secretary deems it necessary to pos |