Under § 406(b) of the Federal Food, Drug, and Cosmetic Act, the
Food and Drug Administration, in 1969, certified as "harmless and
suitable for use in food" a coal tar color which has been used for
many years in coloring oranges. After new tests in 1951-1953 had
shown that the color had toxic effects on animals, and after public
notice and hearings, the Secretary of Health, Education, and
Welfare, in 1955, ordered the color removed from the certified
list. Under §§ 301 and 402(c) of the Act, this had the effect of
making it unlawful to ship in interstate commerce any food bearing
or containing such color. The Secretary did not determine that the
color was harmful for human consumption in the amounts used in
coloring oranges, but only that the color itself was not "harmless
and suitable for use in food" within the meaning of § 406(b), and
he took the position that he had no authority to determine whether
it was "required in the production" of food within the meaning of §
406(a) or to promulgate thereunder a safe tolerance for its use on
oranges. In a review proceeding under § 701(f), the Court of
Appeals set aside the order insofar as it removed the certification
of that color as harmless and suitable for use as external coloring
on oranges.
Held: the Secretary's order was lawful, and it must be
sustained. Pp.
358 U. S.
160-165.
(a) In §§ 402(c) and 406(b), dealing specifically with coal tar
colors, Congress carefully outlined the special treatment to be
given to coal tar colors: the test of certification provided
concentrates on the color substance itself; it is to be certified
only if it is harmless. Pp.
358 U. S.
160-162.
(b) This special method of dealing with coal tar colors relieves
the Secretary from showing in such case that a food containing
Page 358 U. S. 154
them raises a possibility of injury to health; and it makes no
requirement that the colors be tested by experimental feeding in
the proportions in which they are used in specific food products.
Pp.
358 U. S.
162-164.
(c) The evidence justified the Secretary's finding that the
color here involved was poisonous. P. 164,
n 13.
(d) In forbidding the use of coal tar colors, in foods, the
Secretary is not required to restrict his prohibition to specific
food uses in whish the color is shown to have a deleterious effect.
Pp.
358 U. S.
164-165.
2. The Secretary is not authorized by § 406(a) to permit the use
of harmful coal tar colors in specific foods through a system of
tolerances, since that section does not apply to § 402(c)'s flat
prohibition against the use of uncertified coal tar colors. Pp.
358 U. S.
165-176.
3. That special legislation has permitted the use of the color
here involved solely in application to the skin of oranges for a
temporary period ending March 1, 1959, does not render this case
moot, or prevent respondents from being persons "adversely
affected" by the Secretary's order within the meaning of § 701(f).
Pp.
358 U. S.
167-168.
246 F.2d 850 reversed.
MR. JUSTICE BRENNAN delivered the opinion of the Court.
Commercially grown Florida and Texas oranges have for many years
been colored with a red coal tar color. In 1939,
Page 358 U. S. 155
the Food and Drug Administration, after testing and pursuant to
§ 406(b) of the Federal Food, Drug, and Cosmetic Act, [
Footnote 1] certified this color,
FD&C Red No. 32 (hereafter Red 32), to be harmless and suitable
for use in food. However, the Secretary of Health, Education, and
Welfare, on November 10, 1955, ordered Red 32 and two other coal
tar colors to be removed from the certified list, after new tests
in 1951-1953 cast doubt whether Red 32 was harmless, and after
public hearings were held upon the matter on notice published in
the Federal Register. The consequence of the Secretary's order was
that, under § 402(c) of the Act, [
Footnote 2] any food bearing or containing such colors
would be deemed to be adulterated.
The validity of the Secretary's order was attacked in petitions
under § 701(f) of the Act [
Footnote
3] filed in several
Page 358 U. S. 156
Courts of Appeals [
Footnote
4] by persons and organizations claiming to be adversely
affected. The Court of Appeals for the Second Circuit sustained the
order against a general attack.
Certified Color Industry
Committee v. Secretary of Health, Education and Welfare, 236
F.2d 866. In the instant case, [
Footnote 5] however, the Court of Appeals for the Fifth
Circuit, by a divided vote, set aside the order [
Footnote 6] insofar as
Page 358 U. S. 157
it removed the certification of Red 32 as harmless and suitable
for use as external coloring on Florida and Texas oranges. 246 F.2d
850.
The Secretary did not determine that Red 32, in the quantities
used in color-added oranges, was harmful for human consumption,
but, rather, determined, on the basis of the 1951-1953 tests, only
that Red 32 and the other suspect coal tar colors were toxic, and
therefore not "harmless and suitable for use in food." The Court of
Appeals held that the 1939 finding that Red 32 was harmless "should
not be supplanted" by a contrary finding
"unless there is evidence that, in the amounts used, and in the
manner of use, oranges colored with Red 32 are unsafe for human
consumption."
246 F.2d at 861-862. The word "harmless" was construed to be a
term "of relation," preventing the Secretary from denying the
continued use of Red 32 in the quantities used in color-added
oranges in the absence of evidence that such quantities could not
be consumed "without risk of injury or harm."
Id. at 858.
The Court of Appeals held further that, in light of its premise
that "harmless" was a term of relation, and because two
congressional Committees had found that the practice of adding the
color to oranges was an economic necessity, it would be incumbent
upon the Secretary to determine whether the use of the color was
"required in the production" of food within the meaning of §
406(a), [
Footnote 7]
Page 358 U. S. 158
and, if so, promulgate a safe tolerance for Red 32 on oranges
pursuant to that section. Until such a tolerance was promulgated,
the court held that the Secretary was required to certify Red 32 as
a safe color for use on oranges without one.
Id. at
860-862. We granted certiorari to determine this controversial
question of construction of this important statute designed for the
protection of the public health.
Folsom v. Florida Citrus
Exchange, 356 U.S. 911.
Senate and House Committees have reported that the practice of
adding color is an economic necessity in the production of Florida
and Texas oranges for market. [
Footnote 8] When mature oranges are removed from the tree,
their skins, for botanical reasons unnecessary to detail here, are
frequently green in color. Since the consumer would be prone
incorrectly to interpret this greenness as a sign of immaturity,
oranges are put through a "degreening" process which involves
exposure to ethylene gas. In the case of certain California
oranges, this gas process is sufficient to turn a green orange into
one of the desired orange color. But the degreening process does
not produce the desired color in Florida and Texas oranges; a light
yellow shade results. The more desired color is therefore produced
by immersing the oranges in, or spraying them with, a solution
containing Red 32. The evidence at the hearings held by the
Secretary was that the process infuses
Page 358 U. S. 159
the peel of an orange with 0.0017% to 0.0034% of Red 32. Other
evidence indicated that oranges taken as a whole, and candied peel,
marmalade, and orange juice, would contain less -- in many cases,
much less -- of the coal tar color. It is conceded by the Secretary
that there is no evidence that the level of ingestion of Red 32
involved in human consumption of color-added oranges is
harmful.
However, the evidence at the Secretary's hearing did indicate
that Red 32 had a poisonous effect on animals. Feeding the color to
rats in quantities as small as 0.1% of their diet was deleterious
and often fatal, with liver damage and enlargement of the heart in
evidence. In larger quantities, 1.0% and 2.0% of the diet,
ingestion of Red 32 by rats caused death within twelve days and a
week, respectively. The health of dogs taking 0.2% of the color in
their diets deteriorated rapidly; that of those taking 0.04%
somewhat more slowly, but definitely; and ill effects were
indicated at a feeding level as low as 0.01% of the diet. No safe
level of administration of Red 32 to the test animals was
established. These and similar tests, involving the administration
of Red 32 and the other coal tar colors involved to test animals
generally as an item of diet, were the basis on which the
Secretary's order rested.
The Secretary argues that the legislative history and the
consistent administrative interpretation of the Act establish that
his authority to list or continue the listing of coal tar colors is
confined to his authority under § 406(b) to certify "harmless" coal
tar colors, those which are wholly innocuous and demonstrated to be
without adverse physiological effect. The argument runs that a
toxic coal tar color, such as the Court of Appeals agreed that Red
32 was, was to be prohibited completely without regard to whether
it might possibly be used in safe amounts on a particular food
product. The Secretary argues further that, since Congress made
known its will
Page 358 U. S. 160
specifically and precisely in § 406(b) that a toxic coal tar
color, that is, one not "harmless," was not to be certified under
any circumstances, the tolerance provisions of § 406(a) have no
relevance to the validity of his order.
We are of the opinion that the Court of Appeals erred, and that
its judgment cannot stand.
First. The provisions of §§ 402(c) and 406(b) dealing
expressly with coal tar colors were innovations in the Federal
Food, Drug, and Cosmetic Act of 1938; there were no counterpart
provisions in the original 1906 food and drug legislation. By these
provisions, Congress carefully distinguished the treatment to be
given by the Secretary to toxic coal tar colors. The original Act
dealt generally with poisonous and other deleterious substances in
food, as are now treated under § 402(a), but it did not deal
specifically with coal tar colors. Section 7 of the original Food
and Drugs Act, 34 Stat. 769, provided that an article of food
should be deemed adulterated "If it contain any added poisonous or
other added deleterious ingredient which may render such article
injurious to health. . . ." This Court held, in
United States
v. Lexington Mill & Elevator Co., 232 U.
S. 399, following the "plain meaning" of the statutory
language, that this placed the burden upon the Government of
establishing that the added substance was such as might render the
food to which it was added injurious to health. This rule applied
without distinction where coal tar colors were involved. Congress
was aware of the difficulties of this test which required that the
questioned food product be evaluated as a whole, and of the
existence in this area of an informal certification practice under
the 1906 Act, under which not food products, but the coal tar
colors themselves, were subjected to test to determine their
poisonous or harmful character.
Cf. S.Rep. No. 361, 74th
Cong., 1st Sess., pp. 7-8. Of course, when litigation occurred, the
Lexington Mill standard was applied.
Page 358 U. S. 161
See W.B. Wood Manufacturing Co. v. United States, 286
F. 84, 86-87.
It was against this background that the 1938 statute was
proposed and enacted. It is obvious to us that an approach
different from the rule in
Lexington Mill was intended by
Congress when, in § 402(c) [
Footnote 9] and § 406(b), it addressed itself to the
severable and narrow problem of coal tar colors. The language
involved in
Lexington Mill survived generally in the Act's
broadest and most general test of food adulteration, § 402(a)(1).
[
Footnote 10] Section 402(c)
provided a separate test: that a food should be deemed
adulterated
"If it 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 406. . . ."
Plainly, Congress banned any addition to foods of coal tar
colors not certified by the Secretary. The standard established for
the Secretary was set forth in § 406(b):
"The Secretary shall promulgate regulations providing for the
listing of coal tar colors which are harmless and suitable for use
in food and for the certification of batches of such colors. . .
."
There appears in Senator
Page 358 U. S. 162
Copeland's memorandum on the first of the bills which led to the
1938 Act, S. 1944, 73d Cong., 1st Sess., which contained new
provisions on coal tar colors similar to the ones in the Act as
finally passed, a clear indication that one of the purposes of
these provisions was to do away, in this area, with the
Lexington Mill approach. 77 Cong.Rec. 5721. This had the
effect of making the certification system, in which analysis
concentrated on the color substances themselves, rather than an
examination of the effect of the use of the colors in the context
of the food products involved, the conclusive test of adulteration.
Thus it is that the test of certification laid down in § 406(b)
concentrates on the color substance itself; it is to be listed only
if it is harmless. The Secretary is to address himself to the
harmless character of the substance first; once this is assured,
the statutory plan is that it may be freely used in foods, subject
to the provisions of the other sections of the Act. Clearly such a
plan is a rational one to ascribe to Congress. It is true that the
ultimate purpose here concerned of the adulteration provisions of
the Act is to protect health, and that no one makes the color
substances by themselves an item of diet. But it certainly was
competent for Congress, in the light of what were recognized
problems to health in the use of such added colors, to adopt a rule
of caution in treating this recognized and definable problem area.
This rule of caution is here one which relieves the Secretary from
the burden of showing in each case that a food containing them
raises a possibility of injury to health, and requires that the
color stuffs, whose positive values are only visual and which are
not naturally found in foods, not be added unless they could pass a
higher standard.
The significance of such an approach is demonstrated here. No
safe level for ingestion of Red 32 has been established, either in
respect of humans or of animals. No one contends that it is
impossible that ill effects will be experienced
Page 358 U. S. 163
in human beings if unrestricted use of the substance is
permitted in articles of food. On the other hand, no instance of a
harmful use of Red 32 in a particular food was established in the
record. [
Footnote 11] These
questions present broad inquiries, difficult of proof, and
doubtless apt to be more long drawn out in investigation than even
the ones which the Secretary pursued. Yet it has been shown that
the color, of itself, has poisonous properties. In the light of the
overall purpose of the Act,
cf. United States v.
Dotterweich, 320 U. S. 277,
320 U. S. 280,
and the specific terms here involved, it seems to us that Congress
did not intend that a verdict of "not proven" on the questions
mentioned should preclude the Government from preventing the use of
substances like the one in question when they were shown to have
poisonous effects by themselves.
We are not persuaded by the respondents' argument, adopted by
the Court of Appeals, that the words "harmless" and "poisonous" are
relative words, referring not to the effect of a substance
in
vacuo, but to its effect taken in a particular way and in
particular quantities, on an organic system. Of course this is so,
but the question before us certainly does not depend on it. This is
not a case like the examples put which remind us that pure water
would be deleterious if taken at the rate of four gallons an hour
or common table salt at several ounces. The color substances appear
to have been administered at
Page 358 U. S. 164
toxicologically significant levels; they played a relatively
small part in the diets of the test animals, generally less, and
frequently much less, than 1%. [
Footnote 12] Obviously, if the color substances
themselves are made an item of diet in the trifling percentages
used on the test animals, their effect is poisonous. [
Footnote 13] Congress may have
intended "harmless" in a relative sense, but we think it was in
relation to such laboratory tests as the ones the Secretary
performed that Congress was speaking when it required that coal tar
colors be "harmless." We do not believe that Congress required the
Secretary first to attempt to analyze the uses being made of the
colors in the market place, and then feed them experimentally only
in the proportions in which they appeared in certain of the food
products in which the colors were used. This appears to be the very
procedure on which Congress turned its back in the 1938 Act.
The respondents contend that, since the Secretary himself
maintains various lists of certified colors, one containing colors
harmless and suitable for all food, drug and cosmetic uses, another
of colors harmless and suitable for general use in drugs and
cosmetics, and a third of colors harmless and suitable for external
use in drugs and cosmetics, 21 CFR §§ 9.3, 9.4, 9.5, he has
recognized that "harmless," as used in the statute, does not bear
the "absolute" meaning he is alleged to give it. From this, it is
said to follow that the Secretary must, in forbidding the use of
colors in foods, restrict his prohibition to specific food uses in
which the color is shown to be capable of a deleterious
Page 358 U. S. 165
effect. We do not draw this inference. Provisions similar to
those dealing with the use of coal tar colors in foods are repeated
in the portions of the Act dealing with drugs and with cosmetics.
Section 501(a)(4), 52 Stat. 1049, 21 U.S.C. § 351(a)(4), proscribes
the use of uncertified colors in drugs for the purpose of coloring,
and refers to § 504, 52 Stat. 1052, 21 U.S.C. § 354, which
authorizes the listing and certification of coal tar colors which
are "harmless and suitable for use in drugs." Comparable provisions
are found with respect to cosmetics in §§ 601(e) and 604, 52 Stat.
1054, 1055, 21 U.S.C. §§ 361(e). It is clear from these provisions
that Congress contemplated that a color might be harmless in
respect of drugs or cosmetics, but not of foods. And the fact that
the Secretary has established a further category, distinguishing
between colors intended for external and for general use, we do not
think inconsistent with our interpretation of the Act. These
distinctions can be established through tests run on the color
substance as such, in the way in which the Secretary has conducted
the tests in the matter before us. It is a far cry from saying that
the Act permits a generic distinction capable of laboratory proof,
between external and internal uses of a color, to say that it
commands that the colors cannot be inquired of at all except in the
specific contexts of their use in food, drug and cosmetic
products.
Second. But even if the Secretary's approach of viewing
the harmlessness of coal tar colors in terms of the colors
themselves, rather than in their specific applications, is correct,
the respondents insist, as the court below indicated, that the
Secretary should establish tolerances for the use of colors in food
even though not found to be "harmless." The respondents point to §
406(a) of the Act which allows the Secretary to establish
tolerances for poisonous substances added to food where the
substance is "required in the production" of the food or "cannot
be
Page 358 U. S. 166
avoided by good manufacturing practice." They argue that this
provision should be used by the Secretary to establish a maximum
tolerance for the application of Red 32 to the skins of oranges,
either because it applies by its own terms or it is applicable by
analogy. [
Footnote 14] The
Secretary contends that he is without power to permit the use of
harmful coal tar colors in specific foods through a system of
tolerances. We believe he is correct.
The Federal Food, Drug, and Cosmetic Act is a detailed and
thorough piece of legislation. Its treatment of many public health
and food problems is quite specific, and, of course, it is the duty
of the courts, in construing it, to be mindful of its approach in
terms of draftsmanship. Here again, in our construction of this
explicit Act, we must be sensitive to what Congress has written,
and recall that "It is for us to ascertain -- neither to add nor to
subtract, neither to delete nor to distort."
62 Cases of Jam v.
United States, 340 U. S. 593,
340 U. S. 596.
Section 406(a), which provides for the system of tolerances,
constitutes, by its terms, a definition of the term "unsafe," which
appears in § 402(a)(2), a prohibition of foods which bear or
contain "any added poisonous or added deleterious substance which
is unsafe within the meaning of section 406." This is a prohibition
entirely separate and distinct from the prohibitions of § 402(c) on
foods containing or bearing uncertified coal tar colors. The
existence of a tolerance is specifically stated in § 406(a) only to
give sanction to what would otherwise amount to adulteration within
the terms of § 402(a)(1). Accordingly, it is obvious from the
language of the statute that the provisions
Page 358 U. S. 167
authorizing the establishment of tolerances apply only to §
402(a)(1) and (2), and do not apply to § 402(c)'s flat prohibition
against the use of uncertified colors. Respondents do not direct us
to any substantial contrary indication in the legislative history.
Nor can the tolerance provisions be applied to coal tar colors
through some form of analogy. The command of the statute is plain:
where a coal tar color is not harmless, it is not to be certified;
if it is not certified, it is not to be used at all. In this regard
also, an approach in terms of the toxicity of the coloring
ingredient, rather than of the food product as a whole was chosen
by Congress. It evidently took the view that, unless coal tar
colors were harmless, the considerations of the benefits of visual
appeal that might be urged in favor of their use should not prevail
in the light of the considerations of the public health. In the
case of other sorts of added poisons, though only where they were
required in the production of the food concerned or could not under
good manufacturing practice be avoided, a different congressional
policy was expressed in the 1938 enactment. It is the duty of the
Secretary to give effect to this distinction; he has done so with
apparent substantial uniformity, and has done so here.
Third. After the promulgation of the Secretary's order,
Congress afforded temporary relief to those economically interested
in the coloring or oranges with Red 32. Legislation was enacted in
the summer of 1956 to afford a period of approximately three years
(until March 1, 1959), during which use of the color would be
allowed solely in application to the skins of oranges. [
Footnote 15] The statute does
Page 358 U. S. 168
not, in our view, affect the situation presented to the courts
for judicial review; the Secretary's order remains to be tested
under the permanent provisions of the Act, insofar as they will
affect respondents after March 1, 1959. The statute accordingly
operates as a legislatively ordained stay of the Secretary's order
insofar as it affects the present respondents and those similarly
situated.
See H.R.Rep.No.1982, p. 3, and S.Rep.No. 2391,
p. 3, 84th Cong., 2d Sess. In view of the very temporary nature of
this legislative "stay," the automatic resumption of the
status
quo upon its expiration, and the effect of the order on the
respondents, even during the legislative stay, we agree with the
parties that the matter before us is not moot. The Secretary's
order was the promulgation of a general rule, prospective in
operation, and the facts of the respondents' business are such
that, if the order is upheld, there will be a practical effect on
them even during the span of the temporary legislation.
Accordingly, the respondents remain persons adversely affected by
the Secretary's order, and it is proper for us now to determine the
legal situation in regard to them when the temporary legislation
expires. Under the permanent provisions of §§ 402 and 406 the
Secretary's order was lawful, and the respondents present no
grounds on which they can legally object to its application to
them. The judgment of the Court of Appeals, setting the Secretary's
order aside in part, must be
Reversed.
[
Footnote 1]
The Act, as amended, is 52 Stat. 1040, 21 U.S.C. § 301
et
seq. Section 406(b), 21 Stat. 1049, 21 U.S.C. § 346(b)
provides:
"The Secretary shall promulgate regulations providing for the
listing of coal tar colors which are harmless and suitable for use
in food and for the certification of batches of such colors, with
or without harmless diluents."
[
Footnote 2]
Section 402(c), 52 Stat. 1047, 21 U.S.C. § 342(c), provides that
a food shall be deemed to be adulterated
"If it 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 406. . . ."
Section 301 of the Act prohibits the introduction or delivery
for introduction into interstate commerce, or the receipt in
interstate commerce, and the delivery thereof, of adulterated food,
or the adulteration of food in interstate commerce. 52 Stat. 1042,
21 U.S.C. § 331. Sanctions for the prohibited acts, in the form of
injunction proceedings, criminal prosecutions, and seizure actions,
are provided in §§ 302-304, 52 Stat. 1043, 1044, 21 U.S.C. §§
332-334.
[
Footnote 3]
"In a case of actual controversy as to the validity of any order
under subsection (e), any person who will be adversely affected by
such order if placed in effect may at any time prior to the
ninetieth day after such order is issued file a petition with the
United States Court of Appeals for the circuit wherein such person
resides or has his principal place of business, for a judicial
review of such order. The summons and petition may be served at any
place in the United States. The Secretary, promptly upon service of
the summons and petition, shall certify and file in the court the
transcript of the proceedings and the record on which the Secretary
based his order."
52 Stat. 1055, 21 U.S.C. § 371(f).
[
Footnote 4]
Review was sought in three Courts of Appeals in all. In the
Court of Appeals for the Seventh Circuit, a petition was dismissed
before it was adjudicated.
[
Footnote 5]
The persons and firms who are respondents here are all engaged
in the growing, packing or marketing of Florida or Texas oranges.
One is also interested in the patented process whereby the Red 32
color is applied to the skins of oranges.
[
Footnote 6]
The Court of Appeals set aside the order:
". . . insofar as said order removes the coal tar color FD&C
Red No. 32 from the list of colors which may be certified for use
in coloring the skin of oranges meeting minimum maturity standards
prescribed in the State of Florida and Texas; provided, that
nothing herein or in the judgment of this Court entered pursuant
hereto shall restore said coal tar color to the list of colors
which may be certified for unrestricted use in food, drugs, and
cosmetics but shall operate to authorize the certification of
batches of said color conforming to the specifications for the
color appearing at 21 C.F.R. 135.3 (1949 ed.) for the purpose of
coloring the skin of mature oranges only; provided further, that
the Secretary shall be required to certify only sufficient batches
of FD&C Red No. 32 as may be necessary to color the skin of
mature oranges from time to time; provided further, that the
certificates issued for batches of FD&C Red. No. 32 may be
limited by their certificate for use in coloring mature oranges
only; and provided further, that nothing herein or in the judgment
of this Court entered pursuant hereto shall be deemed to restrict
the Secretary from making further investigations and conducting
hearings for a determination of whether the use of Red 32 is
required in the production of oranges and to determine the
tolerances, if any, that are safe and harmless, as harmless is
herein construed and defined."
246 F.2d at 862.
[
Footnote 7]
52 Stat. 1049, 21 U.S.C. § 346(a), which provides:
"(a) 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)
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) 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."
[
Footnote 8]
S.Rep. No. 2391, 84th Cong., 2d Sess., p. 1; H.R.Rep. No. 1982,
84th Cong., 2d Sess., p. 2,.
[
Footnote 9]
The 1938 enactment contained a proviso to § 402(c)
". . . That this paragraph shall not apply to citrus fruit
bearing or containing a coal tar color if application for listing
of such color has been made under this Act and such application has
not been acted on by the Secretary, if such color was commonly used
prior to the enactment of this Act for the purpose of coloring
citrus fruit."
52 Stat. 1047, 21 U.S.C. § 342(c). Respondents suggest that this
proviso somehow suggests a congressional intent to deal with their
color more leniently under the present circumstances, but we can
draw no such inference.
[
Footnote 10]
Section 402(a)(2), with its reference to § 406,
see
note 7 supra, revised
the rule of the
Lexington Mill case substantially in its
own factual context, that of added poisonous substances in food.
Section 402(a)(2) has been the subject of subsequent revisions
itself, the latest one of which is § 3 of the Food Additives
Amendment of 1958, Public Law 85-929, September 6, 1958, 7 Stat.
1784.
See note 12
infra.
[
Footnote 11]
Considerably more of the color was regularly produced before the
entry of the Secretary's order than could be accounted for as
actually being on the skins of oranges. Neither the Government nor
the respondents account for the difference more than speculatively.
The Government urges that the difference must have been used in
other food products. Respondents emphasize the inevitable waste of
quantities of the color during the orange coloring process. To us,
this underlines the approach of the provisions in question; where a
color is found to be harmless in itself, no further inquiry can be
made of it; if it is harmful, none need be.
[
Footnote 12]
A single dose of 100 milligrams of the color substance (0.0035
oz.
avoirdupois, or 1/3 the weight of a standard aspirin
tablet) produced a rapid diarrheic effect in test dogs.
[
Footnote 13]
One respondent assails the validity, even within the framework
of the Secretary's interpretation of the statute, of the tests
performed on the experimental animals. The Court of Appeals found
that the evidence justified the Secretary's finding that the color
was poisonous, 246 F.2d at 859, and we are in agreement.
[
Footnote 14]
The Court of Appeals' judgment had the effect of staying the
Secretary's order in toto as it affected orange coloring until he
developed a tolerance. The Secretary argues here that, even if he
is authorized to establish a tolerance for the use of Red 32 on
oranges, his order should stand until he has established it. In the
view of the case that we take, we do not reach this contention.
[
Footnote 15]
The Act of July 9, 1956, c. 530, 70 Stat. 512, added the
following proviso to § 402(c) of the Act:
"
Provided further, That this paragraph shall not apply
to oranges meeting minimum maturity standards established by or
under the laws of the States in which the oranges were grown and
not intended for processing (other than oranges designated by the
trade as 'packing house elimination'), the skins of which have been
colored at any time prior to March 1, 1959, with the coal tar color
certified prior to the enactment of this proviso as F.D. & C.
Red 32, or certified after such enactment as External D. & C.
Red 14 in accordance with section 21, Code of Federal Regulations,
part 9;
and provided further, That the preceding proviso
shall have no further effect if prior to March 1, 1959, another
coal tar color suitable for coloring oranges is listed under
section 406."