Notes on 21 U.S.C. § 342 : US Code - Notes

Search Notes on 21 U.S.C. § 342 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,
ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68
Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,
Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.
17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Secs. 102(a)(1),
(2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477,
June 29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13,
1968, 82 Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100
Stat. 35; Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106
Stat. 4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat.
776; Pub. L. 103-417, Secs. 4, 9, Oct. 25, 1994, 108 Stat. 4328,
4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat.
1514; Pub. L. 107-188, title III, Sec. 309, June 12, 2002, 116
Stat. 673; Pub. L. 109-59, title VII, Sec. 7202(a), Aug. 10, 2005,
119 Stat. 1911.)
AMENDMENTS
2005 - Par. (i). Pub. L. 109-59 added par. (i).
2002 - Par. (h). Pub. L. 107-188 added par. (h).
1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
former subpar. (2) which read as follows: "(2)(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 346 of this title, 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 346a(a) of
this title, or (C) if it is, or if it bears or contains, any food
additive which is unsafe within the meaning of section 348 of this
title: 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 346a of this title
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 346 and 348 of this title, 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 360b of this title;". That part of
Pub. L. 104-170 which directed the substitution of "or (3) if it
consists" for "(3) if it consists" was executed by making the
substitution for "(3) If it consists" to reflect the probable
intent of Congress.
1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a
period for "; or" at end of subpar. (1) and "If it" for "if it" at
beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1),
which directed the substitution of a period for "; or" at end of
subpar. (2) could not be executed because "; or" did not appear.
Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ", except
that this subparagraph" for ": Provided, That this clause".
Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ", except
that this subparagraph shall not apply" for ": Provided, That this
clause shall not apply" and ", except that the Secretary may, for
the purpose of avoiding or resolving uncertainty as to the
application of this subparagraph" for ": And provided further, That
the Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this clause".
1992 - Par. (c). Pub. L. 102-571 substituted "379e(a)" for
"376(a)".
1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this
clause not apply to confectionery introduced or delivered for
introduction into or received or held for sale in, interstate
commerce if the sale is permitted under the laws of the State in
which the confectionery is intended to be offered for sale.
1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of
nonnutritive objects in confectionery foods if in the judgment of
the Secretary of Health, Education, and Welfare, as provided by
regulation, the imbedding of the object is of practical functional
value to the confectionery product and would not render it
injurious or hazardous to health, raised to one-half of 1 per
centum by volume the upper limit for the allowable use of alcohol
derived solely from the use of flavoring extracts, allowed the use
of safe nonnutritive substances in and on confectionery foods by
reason of their use for some practical and functional purpose in
the manufacture, packaging, or storage of the confectionery foods
if the use of the substances does not promote deception of the
consumer or otherwise result in adulteration or misbranding,
authorized the Secretary to issue regulations on the use of
particular nonnutritive substances, and removed reference to
nonnutritive masticatory substances added to chewing gum and
harmless flavoring, harmless resinous glaze not in excess of four-
tenths of 1 per centum, natural gum, authorized coloring, and
pectin.
1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted
"other than one which is (i) a pesticide chemical in or on a raw
agricultural commodity; (ii) a food additive; or (iii) a color
additive" for "(except a pesticide chemical in or on a raw
agricultural commodity and except a food additive)" in cl. (2)(A).
Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
generally, substituting provisions deeming a food adulterated if it
is, or it bears or contains, a color additive which is unsafe
within the meaning of section 376 of this title for provisions
which related to food that bears or contains a coal-tar color other
than one from a batch that has been certified in accordance with
regulations as provided by section 346 of this title, and struck
out provisos which related to the use of color on oranges.
Par. (d). Pub. L. 86-618, Sec. 105(c), substituted "authorized
coloring" for "harmless coloring".
1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May
1, 1959, the period during which subsection is inapplicable to
oranges which have been colored with F.D.&C. Red 32, and inserted
proviso requiring Secretary to establish regulations prescribing
the conditions under which Citrus Red No. 2 may be safely used in
coloring certain mature oranges, and providing for separately
listing and for certification of batches of such color.
1958 - Par. (a). Pub. L. 85-929, among other changes, inserted
cl. (2)(C) relating to food additive unsafe within the meaning of
section 348 of this title, and to pesticide chemical, and added cl.
(7) relating to radiated food.
1956 - Par. (c). Act July 9, 1956, inserted second proviso
relating to coloring of oranges.
1954 - Par. (a)(2). Act July 22, 1954, provided in the case of
any raw agricultural commodity bearing or containing a pesticide
chemical, that such commodity shall be deemed to be adulterated if
such pesticide chemical is unsafe within the meaning of section
346a of this title.
1950 - Par. (e). Act Mar. 16, 1950, added par. (e).
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
7204 of Pub. L. 109-59, set out as a note under section 331 of this
title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
DESICCANT AMENDMENT OF 1959
Effective date of par. (a)(2) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural
commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
139, Aug. 7, 1959, 73 Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
Stat. 1002, provided that:
"(a) Except as provided in subsections (b) and (c) of this
section, this Act [amending this section, sections 321, 331, 346,
and 348 of this title, and section 210 of Title 42, The Public
Health and Welfare, and enacting provisions set out as notes under
sections 321 and 451 of this title] shall take effect on the date
of its enactment [Sept. 6, 1958].
"(b) Except as provided in subsection (c) of this section,
section 3 of this Act [amending this section and section 346 of
this title] shall take effect on the one hundred and eightieth day
after the date of enactment of this Act [Sept. 6, 1958].
"(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1,
1958, section 3 of this Act [amending this section and section 346
of this title] shall take effect -
"(1) Either (A) one year after the effective date established
in subsection (b) of this section, or (B) at the end of such
additional period (but not later than two years from such
effective date established in subsection (b)) as the Secretary of
Health, Education, and Welfare [now Health and Human Services]
may prescribe on the basis of a finding that such extension
involves no undue risk to the public health and that conditions
exist which necessitate the prescribing of such an additional
period, or
"(2) on the date on which an order with respect to such use
under section 409 of the Federal Food, Drug, and Cosmetic Act
[section 348 of this title] becomes effective,
whichever date first occurs. Whenever the Secretary has, pursuant
to clause (1)(B) of this subsection, extended the effective date of
section 3 of this Act [amending this section] to March 5, 1961, or
has on that date a request for such extension pending before him,
with respect to any such particular use of a food additive, he may,
notwithstanding the parenthetical time limitation in that clause,
further extend such effective date, not beyond June 30, 1964, under
the authority of that clause (but subject to clause (2)) with
respect to such use of the additive (or a more limited specified
use or uses thereof) if, in addition to making the findings
required by clause (1)(B), he finds (i) that bona fide action to
determine the applicability of such section 409 [section 348 of
this title] to such use or uses, or to develop the scientific data
necessary for action under such section, was commenced by an
interested person before March 6, 1960, and was thereafter pursued
with reasonable diligence, and (ii) that in the Secretary's
judgment such extension is consistent with the objective of
carrying to completion in good faith, as soon as reasonably
practicable, the scientific investigations necessary as a basis for
action under such section 409 [section 348 of this title]:
Provided, That if the Secretary has, pursuant to this sentence,
granted an extension to June 30, 1964, he may, upon making the
findings required by clause (1)(B) of this subsection and clauses
(i) and (ii) of this sentence, further extend such effective date,
but not beyond December 31, 1965. The Secretary may at any time
terminate an extension so granted if he finds that it should not
have been granted, or that by reason of a change in circumstances
the basis for such extension no longer exists, or that there has
been a failure to comply with a requirement for submission of
progress reports or with other conditions attached to such
extension."
EFFECTIVE DATE OF 1954 AMENDMENT
Section 5 of act July 22, 1954, provided that: "This Act
[amending this section and section 321 of this title and enacting
sections 346a and 346b of this title] shall take effect upon the
date of its enactment [July 22, 1954], except that with respect to
pesticide chemicals for which tolerances or exemptions have not
been established under section 408 of the Federal Food, Drug, and
Cosmetic Act [section 346a of this title], the amendment to section
402(a) of such Act [par. (a) of this section] made by section 2 of
this Act shall not be effective -
"(1) for the period of one year following the date of the
enactment of this Act [July 22, 1954]; or
"(2) for such additional period following such period of one
year, but not extending beyond two years after the date of the
enactment of this Act [July 22, 1954] as the Secretary of Health,
Education, and Welfare [now Health and Human Services] may
prescribe on the basis of a finding that conditions exist which
necessitate the prescribing of such additional period."
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950, see
section 7 of act Mar. 16, 1950, set out as an Effective Date note
under section 347 of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
53 Stat. 853, set out as an Effective Date; Postponement in Certain
Cases note under section 301 of this title.
SHORT TITLE
Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
"That this Act [amending provisions set out as a note under this
section and section 135 of Title 7, Agriculture] may be cited as
the 'Food Additives Transitional Provisions Amendment of 1964'."
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS
OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY
PURCHASE PROGRAMS
Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.
1601, provided that: "Hereafter, notwithstanding any other
provision of law, any domestic fish or fish product produced in
compliance with food safety standards or procedures accepted by the
Food and Drug Administration as satisfying the requirements of the
'Procedures for the Safe and Sanitary Processing and Importing of
Fish and Fish Products' (published by the Food and Drug
Administration as a final regulation in the Federal Register of
December 18, 1995), shall be deemed to have met any inspection
requirements of the Department of Agriculture or other Federal
agency for any Federal commodity purchase program, including the
program authorized under section 32 of the Act of August 24, 1935
(7 U.S.C. 612c) except that the Department of Agriculture or other
Federal agency may utilize lot inspection to establish a reasonable
degree of certainty that fish or fish products purchased under a
Federal commodity purchase program, including the program
authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.
612c), meet Federal product specifications."
(!1) So in original. The period probably should be "; or".
(!2) So in original. Probably should be "subparagraph".