# Petition — Hicks v. United States

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition
- **Published:** January 1, 1979
- **Citation:** 441 U.S. 923

## Text

~~ Supreme Court, 0. &
FILED

FEB 14 1979

A r
IN THE iuetiicieemeees tes

Supreme Court of the United States

Ocroser Term, 1978

no. BS- 1267

BILLY WD. HICKS,
> Petitioner,

—against—

UNITED STATES OF AMERICA, JESSIE P. BAR-
NETT, JR. and BARNETT & SONS SALVAGE,

LTD.,
Respondents.

PETITION OF BILLY D. HICKS FOR A WRIT OF
CERTIORARI TO THE UNITED STATES COURT
OF APPEALS FOR THE FIFTH CIRCUIT

Evoense G. Lams
Attorney for Petitioner
226 Seventh Street
Garden City, New York 11530
(516) 248-1455

TABLE OF CONTENTS

PAGE
J URISDICTION 2
Questions PREsENTED ror REVIEW 2
ConstiruTionaL Provisions anp Statutes Invotveo 3
STATEMENT OF THE CaSE 3
Reasons For GRANTING THE WRIT 5
Conclusion 10
APPENDIX:

Opinion of the United States Court of Appeals
for the Fifth Circuit la

Judgment of the United States Court of Ap-
peals for the Fifth Circuit 17a

Order Granting Stay of the Issuance of the
Mandate Pending Petition for Writ of Cer-
tiorari on 19a

Constitutional Provisions Involved 2la

Statutes Involved 22a

ii TABLE OF CONTENTS

Cases Cited

United States v. Forty-One Cases, 420 F. 2d 1126
(CA 5 1970)

United States v. Four Hundred Eighty Four Bags,
More or Less, 423 F. 2d 839 (CA_5 1970) ...... mn

United States v. Halls, 529 F. 2d 472 (CA 5 1976)
United States v. Insco, 496 F. 2d 204 (CA 5 1974)
Wiliams vy. United States, 179 F. 2d 644

PAGE

Coan a

IN THE

Supreme Court of the United States

Ocroser Term, 1978

No.

BILLY D. HICKS,
Petitioner,

—against—

UNITED STATES OF AMERICA, JESSIE P. BAR-
NETT, JR. and BARNETT & SONS SALVAGE,

LTD.,
Respondents.

i.
—_

PETITION OF BILLY D. HICKS FOR A WRIT OF
CERTIORARI TO THE UNITED STATES COURT
OF APPEALS FOR THE FIFTH CIRCUIT

To the Honorable the Chief Justice aud Associate Justices
of the Supreme Court of the United States:

Petitioner, Billy D. Hicks, prays that a writ of certio-
rari be issued to review the decision and judgment of the
United States Court of Appeals for the Fifth Circuit
affirming a judgment and sentence of the United States
District Court for the Northern District of Mississippi

after a jury trial entered on the 30th day of November,
1977 wherein the Petitioner was found guilty of six felony
counts as contained in the presented indictment which
detailed violations of Sees. 2 and 371, Title 18, and
Sees. 321 (f), 331 (a), 331 (k), 333 (b), 342 (a)(1),
342 (a)(2)(c), 343 (a) and 348, Title 21 United States
Code by aiding and abetting; conspiracy; interstate ship-
ment of adulterated food; fraudulent sale of misbranded
food in interstate commerce.

The opinion of the Court of Appeals is reported at
587 F 2d 252 and a copy thereof is appended hereto
(infra, pp. la to 16a).

Jurisdiction

On January 8, 1979 judgment was initially entered in
the United States Court of Appeals, Fifth Circuit, unani-
mously affirming the judgment of conviction of the United
States District Court for the Northern District of Missi-
ssippi.

The issuance of the mandate of the Court was stayed
until, to and including February 15, 1979 pending the
filing of this petition for a writ of certiorari by order

entered in the Office of the Clerk of the Court of Appeals
on February 5, 1979.

The jurisdiction of this Court is invoked under 28

U.S.C. See. 1254 (1) and Rule 19.1 (b) of the rules of
this Court.

Questions Presented

(1) Is the Statute 21 U.S.C. 342 (a) (1) defining adult-
eration of food so vague and indefinite to be inadequate
to satisfy the due process clause of the Fifth Amendment

3

to the United States Constitution in that it fails to inform
the Defendant or any other person of ordinary intelli-

gence of the conduct prohibited by its terms?

(2) Whether application of Section 342 (a) (1) as ap-
plied in the trial was ex post facto in that it was left
to the jury, based on the testimony of the government
experts, to determine the standard of law which was al-
legedly violated, i.e. that the substances found came within
the definition of 342 (a) (1).

Constitutional Provisions and Statutes Involved

Fifth Amendment to the Constitution of the United
States; Article 1, Section 9 of the Constitution of the
United States.

Title 19 U.S.C. Sec. 2 and 371; Title 21 U.S.C. Secs.
321 (f), 331 (a), 331 (k), 3383 (b), 342 (a) (1), 342 (a)
(2) (c), 343 (a), 346 (a) and 348.

The text of the above are set forth in the Appendix
hereto (infra pp. 21a et seq.).

Statement of the Case

Billy D. Hicks, a citizen and resident of McGehee,
Arkansas, entered into an agreement with Jessie P. Bar-
nett, Jr., of Opelousas, Louisiana, and Richard Flowers
of Tunica, Mississippi, wherein it was agreed that Hicks
would supply salvage cotton seed which had been treated

for planting, to Flowers for processing at Planters Oil

Mill in Tunica, into cottonseed meal, hulls and oil. Bar-
nett was to handle the marketing and sale of the meal
and did make a contract with Southern Feed Ingredients
to Memphis, Tennessee, for the sale of twelve carloads
of cottonseed meal.

Pad

4

Approximately 2,000 tons of seed was processed into
meal by the Planters Oil Mill, the bulk having been
delivered and supplied by third parties, although Hicks
did direct the delivery of a substantial portion of the
treated seed to the oil mill.

Samples of the meal were taken and forwarded to Bar-
row-Agee Laboratories in Memphis for chemical analysis.
According to the reports, there were only trace elements
of poisonous substances.

Southern Feed Ingredients brokered the cottonseed meal
to various purchasers, principally animal feed companies,
for use as an animal feed ingredient. A railcar load
of the meal was tested in Starkville, Mississippi, by the
Mississippi authorities and the tests revealed that the
meal contained the substance Disyston. The Food and
Drug Administration took control of the investigation
and the shipments of the meal were stopped.

During the course of a six day trial which commenced
on October 25, 1977, pursuant to the Grand Jury’s in-
dictment handed down on May 25, 1977, the Government
introduced evidence through FDA investigators to show
involvement and control by Petitioner Hicks and his co-
defendants, Jessie P. Barnett and the Barnett Corpora-
tion, and that the cottonseed meal was adulterated. The
principal witnesses for the Government, Drs. Buck and
Piper, testified as to the harmful effects of the sub-
stances, mercury, disyston and PCNB, and to the effect
that because of their experience in observing poisoned
animals in laboratory tests, that they considered the sub-
stances as unsafe.

The Jury received instructions, one of which required
the Jury to consider whether or not mercury, disyston

and PCNB were unsafe and thus, adulterating food ad-
ditives.

5

The Jury found all defendants guilty on the six felony
counts. Judgment was entered on November 30, 197 7.
The United States Court of Appeals for the Fifth Cir-
cuit affirmed said judgment on January 8th, 1979.

REASONS FOR GRANTING THE WRIT
I

Hicks is charged with conspiracy to introduce into inter-
state commerce an adulterated food in violation of 21
U.S.C. 331(a). In describing adulterated food, See. 331(a)
refers to Sees. 342(a)(1), 346(a) and 342(a)(2)(c) and
by reference to Sec. 348.

Generally, the application of these Statutes has been in
civil or seizure actions instituted by the Government to
halt shipment of, or to condemn certain food items. United
States v. Forty-One Cases (1970, Fifth Cireuit) 420 F. 2d,
1126, and United States v. Four Hundred Eighty Four
Bags, More or Less, (1970, Fifth Cireuit, 423 F. 2d 839).

In attempting to define “adulterated”, Sec. 342(a) (1)
states that a food shall be deemed to be adulterated “if
it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; * * *”.

Section 342 (a)(2)(c) states that a food shall be deemed
to be adulterated “if it is, or it bears or contains, any
food additive which is unsafe within the meaning of Sec-
tion 409 (21 U.S.C. 348).”

The foregoing sub-sections each describe a different test
as to what is deemed to be adulterated food. However,
342 (a)(1) fails to place one on notice of what may be
injurious to health or what does ordinarily cause a food

to be adulterated.

6

It is undisputed that Planters’ Oil Mill, Inc., the pro-
cessor of the cottonseed meal, sent samples of the meal
to a laboratory in Memphsis for analysis, which reported
that the samples contained “less than .01 parts per mil-
lion” of Disyston, while the report does not indicate

whether or not tests were conducted for mereury or
PCNB.

It is significant to note that one of the customers of
the cottonseed meal also sent samples to the laboratory
of the Mississippi State University, which notified that
the samples contained Disyston, although the record does
not state the quantity. Additionally, the test of the labora-
tory of Mississippi State University does not report any
test for mereury or for PCNB. Later tests of the Food
and Drug Administration reveal the presence of mercury,
PCNB and Disyston, but does not establish quantities so
found. It is common knowledge that the presence of some
trace elements or materials does not necessarily fall within
the definition of “adulterated” as commonly used. The
Government, realizing this proposition put experts in the
field of Toxicology on the stand as witnesses to establish
that the trace elements or materials were deleterious and
injurious to health of animals.

This testimony of the expert witnesses was the subject
of objection by the defendant, Hicks, and the testimony
was allowed in over his specific objection.

342(a)(1) is silent as to what substances are to be eon-
sidered deleterious and injurious to health and nowhere
does the statute proscribe by quantity the amounts of sub-
stances which are to be considered deleterious and injuri-
ous to health.

Conversely, it is within the realm of common knowl-
edge that many materials, trace elements or additives,
which are considered by themselves to be “harmless” to
health, when added to products in sufficient quantities,

neque ey ow

7

become deleterious and injurious to health. The ordinary
person in the handling of such products would not be in a
position to make this determination and would not be,
therefore, aware that he was violating the law.

In the process of establishing as a fact that mercury,
disyston and PCNB were unsafe, the Government demon-
strated that this knowledge was not unknown, but rather
may have been eesaeset only by a select few (it was es-
tablished that the field of Veterinary Toxicology is a high-
ly specialized area where in the United States only 27
Veterinary Toxicologists have been, certified) and it is
claimed that the adduction of this kde inveigh against
establishing a specific intent necessary to violate the stat-
ute which was an essential element of the Government’s

case.

This fundamental dilemma in the formulation of a
criminal statute is reeognized in U.S. v. Insco (1974 Fifth
Circuit) 496 Fed. 2d 204, there the Court stated at Page
208 :

“It is a fundamental tenet of our jurisprudence
that statutes which proscribe conduct may not be
so inartfully worded that persons of common in-
telligence must speculate as to their meaning. Lan-
zetta v. New Jersey, 1939, 306 U. S. 451, 453, 59 S.
Ct. 618, 83 L. Ed. 888. Vaguely phrased measures
run afoul of substantive due process requirements
by failing to convey with reasonable certainty the
statute’s intended sweep. ‘The ‘underlying principle
is that no man shall be held criminally responsible
for the conduct which he could not reasonably un-
derstand to be proscribed.’ United States v. Har-
riss, 1954, 347 U.S. 612, 617, 74 S.Ct. 808, 812, 98
L.Ed. 989.”

and in U. S. v. Halls (1976) Fifth Cireuit, 529 Fed. 2d,
472, the Court stated at Page 479:

8

“. .. In its classic formulation of the standard for
establishing unconstitutional vagueness, the Su-
preme Court held that a penal statute ‘must be suf-
ficiently explicit to inform those who are subject to
it what conduct on their part will render them liable
to its penalties’, If ‘men of common intelligence’
must guess at the meaning of a statute, the statute
violates due process of law.” (Cases cited)

Applying these well settled principles to the case at
Bar, it is apparent that 342(a)(1) does not sufficiently
proscribe the conduct ‘to be prohibited. If'a law embodies
a principle which is to guide the actions of people it is
fundamental that notice of the prohibited conduct be im-
parted.

The assertion of vagueness is not predicated upon the
notion that the Statute defines an illegal act by reference
to the manifest effects of conduct (for example, the com-
mission of acts, which has a bad or a specifically identi-
fied criminal result), but rather the complaint is that the
Statute condemns conduct, that in the opinion of a limited
class, veterinary toxicologists in this case, may be injuri-
ous to the health of animals. Conceivably then, one must
take judicial notice to such factual opinion and thereby
be guided. This would include taking notice of a change
in scientific thought the instant it occurred, even if the
thought or opinion may be subsequently proved in error.
It is obvious that 342(a)(1) contains no definitive stand-
ard of criminal conduct—if it did it would not have been
necessary for the Government to make this proof in the
Court below. As it was, the Jury was asked to pass on
a question that ought to have been predetermined by the
Congress.

Clearly related to the case of vagueness is the consti-
tutional restraint upon Congress from legislating crim-
inal laws ex post facto. Equally, this same restraint ap-
plies to the Federal Courts. Contrary to this restraint,
we find that the Trial Court left it to the jury to deter-
mine the standard of law and to find as a fact whether
or not the substances complained of were deleterious and
injurious to health. In essence, the jury was left to de-
fine a criminal statute where Congress had not, at a point
in time subsequently removed from the enactment of the
statute.

The Court in Williams v. United States, 179 F. 2d 644,
at Pg. 647 of the report, stated:

“The Congress and the Federal Court are them-
selves faced here with the provision of the Fifth
Amendment that no person * * * be deprived of
life, liberty or property without due process of law,
and it is found right in the midst of provisions in
the Fifth and Sixth Amendments about Federal
prosecutions for crime. It is well anderstood that
due process applies not only to Court procedure,
but also to legisiation, especially in criminal mat-
ters. There are no common law Federal crimes,
vut all are created by Statute, though common law
words in the Statute may take their intended mean-
ing from the common law. Not only must the ac-
eusation inform the accused for what he is to be
tried, but due process requires that the Statute must
inform the citizen in advance by a reasonably as-
certainable standard what the crime shall be. A
Judge may not establish the standard, say by rea-
sonable interpretation, after the deed is done, for
that is in substance to give the Statute life ex post
facto, which the Constitution forbids also.”

10

It is clear that the Trial Court did in fact instruct the
jury to give the Statute “life ex post facto” should the
Jury make a positive finding that mercury, disyston and
PCNB were potentially harmful and deleterious to health.

Petitioner urges that the Circuit Court erroneously
relied on the decision of this Court in United States of
America v. Lexington Mul and Elevator Company, 232
U.S. 399; 34 Sup. Ct. Rep. 337 as decisive of the constitu-
tional question. In that case the government proceeded
by civil libel to seize and condemn okienee adul-
terated product and did not proceed by” pads prosecution
as it did in the instant case. This Court did not con-
sider nor pass upon the constitutional questions raised
herein by the petitioner which are of a vastly greater
dimension than this Court had to consider in the prior
case.

CONCLUSION

For the reasons above stated, a Writ of Certiorari
should issue to the United States Court of Appeals
for the Fifth Circuit, review the Judgment and
Decision of that Court affirming the Judgment of
Conviction entered herein in the United States District
Court for the Northern District of Mississippi.

Respectfully submitted,

Evucene G. Lams
Attorney for Petitioner

Dated: Garden City, New York
February 14, 1979

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3 ee 2 ee =

APPENDIX

Opinion of the United States Court of Appeals
for the Fifth Circuit

Unrrep States or AMERICA,
Plaintiff-A ppellee,

Vv.

Jesse P. Barnett, Jr., Barnetr & Sons Satvace, Lp. and
Buy D. Hicks,

Defendants-Appellants.

>

No. 77-5811
Unrrep States Court or APPEALs,

Firra Crmcvuir

Jan. 8, 1979
Appeals from the United States District Court for the

Northern District of Mississippi.

Before Coteman, Crank and Rustin, Circuit Judges.
Coteman, Circuit Judge.

When Theodore Roosevelt was President of the United
States, the misbranding and harmul adulteration of foods
had become of such nationwide moment that Congress
enacted the first Food and Drug Act, 1906.

[1a]

2a

Opinion of the United States Court of Appeals
for the Fifth Circuit

Eight years later, in an appraisal of the Act, the Su-
preme Court said:

The statute upon its face shows, that the pri-
mary purpose of Congress was to prevent injury
to the public health by the sale and transportation
in interstate commerce of misbranded and adul-
terated foods. The legislation, as against misbrand-
ing, intended to make it possible that the con-
sumer should know that an article purchased was
what it purported to be; that it might be bought
for what it really was, and not upon misrepresen-
tations as to character and quality. As against
adulteration, the statute was intended to protect
‘ne public health from possible injury by adding
to articles of food consumption poisonous and dele-
terious substances which might render such articles
injurious to the health of consumers. If this pur-
pose has been effected by plain and unambiguous
language, and the act is within the power of Con-
gress, the only duty of the courts is to give it effect
according to its terms. This principle has been
frequently recognized in this court.

United States v. Lexington Mill Compan
y, 232 US.
399, 409, 34 S.Ct. 337, 340, 58 L.Ed. 658 (1914).
At a later point in that opinion the Court said:

Congress has here, in this statute, with its penal-
ties and forfeitures, definitely outlined its inhibi-
tion against a particular class of adulteration.

232 U.S. at 411, 34 S.Ct. at 340.

_ From time to time the Act has been amended in the
light of new developments and with a view to more ef-

3a

Opinion of the United States Court of Appeals
for the Fifth Circwt

fectively protecting the general public from foods which
may be harmful or which have been misbranded. We
have no doubt that the various provisions of the Act are
plain, that they suffer from no ambiguity amounting to
impermissible vagueness, and that they do not violate the
Constitution.

The grand jury for the Northern District of Mississippi
indicted Jessie P. Barnett, Jr., Billy D. Hicks, and Bar-
nett & Sons Salvage, Ltd., for criminal violations of
these statutes, as well as for a conspiracy to commit those
violations.'

A jury convicted all three defendants on all six counts.

1 Count 2 charged that on or about September 12, 1975, all three
defendants did knowingly, with intent to defraud and mislead, cause
to be introduced into Interstate Commerce at Tunica, Mississippi,
adulterated bulk cottonseed meal, a food, “which was adulterated in
that it contained an added poisonous and deleterious substance, to-
wit, mercury, which may have rendered it injurious to health, and
contained unsafe food additives, to-wit, the fungicide PCNB (penta-
chloronitrobenzene) and the insecticide Disyston (O, O-diethyl S-(2-
Enthylthio) ethyl) phosphorodiathioate, in violation of Section 331
(a), 333(b), 342(a) (1), 342(a)(C), and 348 of Title 21, and of
Section 2 of Title 18 of the United States Code”.

Counts 3, 4, and 5 charged the defendants with committing the
same offenses on September 19, 1975, and September 22, 1975.

Count 6 charged all defendants with knowingly, and with intent
to defraud and mislead, offering for sale and causing to be offered
for sale 1,000 tons of misbranded cottonseed meal processed from
poison-treated cottonseed, theretofore shipped in Interstate Com-
merce to Tunica, Mississippi. f

Count 1 charged a conspiracy to commit the offenses charged in
the remaining counts.

4a

Opinion of the United States Court of Appeals
for the Fifth Circuit

Hicks was sentenced to three years imprisonment on
one count, with eligibility for parole after nine months;
also to a fine of $1,000 and three years probation on each
of the remaining counts, the periods of probation to run
concurrently with each other.

On Count 1, Barnett was sentenced to imprisonment for
six months and to pay one-half of the cost of prosecution;
also to pay a fine of $1,000 and three years probation on
each of the remaining counts, the periods of probation to
run concurrently with each other.

Barnett & Sons Salvage Company, Ltd., was fined $250
on each of the six counts.

All defendants have appealed. We affirm as to all.

The action began on September 1, 1975, when Hicks
made an arrangement with the Planters Oil Mill, Ine., of
Tunica, Mississippi, in which it was agreed that the Mill
would receive cottonseed which had been poison-treated
for planting purposes, process it into cottonseed meal,
and deliver the meal to the railroad agent at Tunica for
transportation to various customers in Interstate Com-
merce. It was further agreed that from this operation
the cost of processing and shipping would first be de-
ducted, after which the parties would split the profits,
if any. Shipment of the treated seed to Planters began
on September 2, contained in bags, marked “Poison-
treated—Do not use for food, feed, or oil”.

In the meantime, Hicks had made a separate arrange-
ment with Jessie P. Barnett, Jr., of Barnett & Sons Sal-
vage Company, Ltd., in which Barnett agreed that his
Company would find buyers for the meal processed from
the treated planting cottonseed.

=

5a

Opinion of the United States Court of Appeals
for the Fifth Circwt

On September 9, Barnett made a contract with Southern
Feed Ingredients Company, a company which deals solely
in components for animal feed, by which Barnett was to
sell Southern 1,000 tons of cottonseed meal. The record
is not clear as to whether Barnett knew initially that the
meal was to be manufactured from treated seed, but there
is no doubt that he soon learned of it. The serious aspect
of this case is that Barnett never informed Southern at
any time that the meal was to be processed from cotton-
seed which had been poison-treated for planting pur-
poses.

At various times and on various dates, within the time
period alleged in the indictment, Planters processed the
treated cottonseed, loaded the resulting meal onto rail-
road cars, and consigned the cars to the railroad agent
at Tunica. The bills of lading contained the warning,
Fertilizer use only. Copies of those bills of lading were
sent to Barnett & Sons and to Southern.

It was during this period that Mr. Barnett really stuck
his hand in the fire by representing to Southern that the
warnings appearing on the bills of lading were erroneous,
that the meal was fit for animal feed. The invoices from
Planters, sent to Hicks and to Barnett & Sons Salvage
Company, Ltd., bore the warning “Fertilizer, chemical or
industrial use only’. Not stopping at this, Planters noti-
fied both Hicks and Barnett & Sons, by certified letter,
return receipt requested, that the Mill had begun con-
signing meal to the railroad agent and that “we want it
fully understood that the products from these seed are
only good for fertilizer, chemical or industrial use.”

On the dates alleged in the indictments Southern di-
rected the railroad agent to ship the meal to various cus-
tomers, as therein charged.

6a

Opinion of the United States Court of Appeals
for the Fifth Circuit

Matters lost no time in coming to a head. One of
Southern’s customers complained “that the meal had a
burned or dark color, and a burned smell”. Southern
then told Planters to send a sample-of the meal to a labora-
tory in Memphis for analysis. On September 19 the sam-
ples were sent. On September 25, the laboratory reported
that the samples contained “less than .01 parts per million”
of Disyston. The report, however, did not indicate that
any test had been conducted for mercury or for PCNB.

The customer also submitted samples of the meal to the
state laboratory at Mississippi State University. On Sep-
tember 22, this laboratory notified the customer that the
meal samples contained Disyston. The customer then re-
called all of the meal that could be traced and shipped it
back to Southern. It informed Southern of the situation
and also informed Mississippi feed inspectors, as well as
investigators for the Food and Drug Administration, that
the meal was tainted.

The Food and Drug Administration investigators took
samples of the meal at Planters, in Tunica, and from all
places to which the meal had been shipped or at which
could be found in transit. Tested by Food and Drug Ad-
ministration laboratories, these samples revealed the pres-
ence of mercury, PCNB, and Disyston.

Hicks

Mr. Hicks complains first that the statutes in question
are unconstitutional. We have already pointed out the
holding of the Supreme Court in United States v. Lexing-
oan Company, 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658

Ta

Opinion of the United States Court of Appeals
for the Fifth Circuit

[1] We agree that, most assuredly, criminal statutes
must fairly apprise those who are subject to them as to
the conduct which is proscribed.2 Even so, “no more than
a reasonable degree of certainty can be demanded”, Boyce
Motor Lines, Inc. v. United States, 342 U.S. 337, 340, 72
S.Ct. 329, 331, 96 L.Ed. 367 (1952).

[2] We can attribute no merit whatever to the conten-
tion that the statutes left the defendants without fair warn-
ing that their acts were illegal. 21 U.S.C. § 331(a) pro-
hibits the “introduction or delivery for introduction into
interstate commerce of any food... that is adulterated.

..” 21 U.S.C. § 342(a)(1) defines an adulterated food as
one bearing or containing “any poisonous or deleterious
substance which may render it injurious to health”. 21
U.S.C. § 321(f) specifies that the term “ ‘food’ means...
articles used for food or drink for man or other ani-

mals... .”

- Hicks testified that only by analysis could it be deter-
mined whether it would be safe to feed the meal. This
does not help him. The cottonseed meal in this case was
sold for feed prior to analysis and this was done with
Hicks’ knowledge. The facts, as previously stated herein,
reflects the warnings received by Hicks that the product
was unfit for animal feed.

[3] Mr. Hicks complains that he was prejudiced by over-
ly extensive expert testimony adduced on behalf of the
government with reference to the harmful effects of mer-
cury, PCNB, and Disyston. Our evaluation of the trial
record, however, leaves us with the firm conviction that

2 United States v. Hawes, 5 Cir. 1976, 529 F.2d 472, 479; United
States v. Insco, 5 Cir., 1974, 496 F.2d .204, 208.

8a

Opinion of the United States Court of Appeals
for the Fifth Circuit

the rulings of the trial court on the materiality and rele-
vancy of this testimony were well within its discretion,
United States v. Grimm, 5 Cir. 1978, 568 F.2d 1136, 1138;
United States v. Brown, 5 Cir. 1977, 547 F.2d 1264, 1266.
Indeed, if Hicks thought that the extensiveness of the proof
as to these rather indisputable facts would put the case
out of focus, to his prejudice, he could easily have elimi-
nated the hazard by merely stipulating the harmfulness,
putting an end of the matter. On the other hand, if there
was any doubt about it, the government was entitled to
nail it down.

BARNETT

Jessie P. Barnett, on his own behalf and that of Barnett
& Sons Salvage, Ltd., urges reversal of their convictions
on the grounds of improperly admitted evidence, an al-
legedly improper notice of an evidentiary fact, insufficient
evidence, and improper consideration of a pre-sentence
report.

A. Admissibility of Evidence

[4] Twelve railears of meal were shipped from Planters.
By the time the FDA could obtain samples for its tests,
meal from three of these cars had been commingled with
meal from other sources. Over objection, the District
Court admitted samples from all twelve ears, including the
three cars containing commingled meal. Barnett contends
that the samples taken from the three commingled cars
were irrelevant and the admission of the samples consti-
tutes reversible error. We disagree.

This argument tries to slough off the fact that there
were nine carloads of meal in which there had been no

9a

Opinion of the United States Court of Appeals
for the Fifth Circuit

commingling and even as to the three in which there had
been commingling, some of the meal had been processed
from the Hicks-Barnett treated cottonseed. The samples
from all twelve cars revealed the presence of the deleteri-
ous substances. in question. Even if it was error to admit
the samples from the three commingled cars, it was obvi-
ously harmless beyond a reasonable doubt and we need not
pause for a prolonged discussion of this point.

B. Insufficient Evidence

[5] Barnett maintains that due to his good faith reliance
on the Barrow-Agee test that there was insufficient evi-
dence of intent to commit a felony and therefore that his
motion for judgment of acquittal should have been granted.

Viewed in the light most favorable to the government,
Glasser v. United States, 315 U.S. 60, 62 S.Ct. 457, 86 L.Ed.
680 (1942), the facts simply do not support this argument.
Barnett had received copies of bills of lading, invoices, and
a letter from Planters, warning in unequivocal terms that
the meal was not to be used for animal feed. Barnett as-
sured Southern that the copies of bills of lading bearing
the warning “Fertilizer use only” were in error and that
the meal was good for feed use.

Moreover, the record shows that samples were not sent
to Barrow-Agee for analysis until ‘September 17, 1975,
where they were received on September 19. The Barrow-
Agee report was not issued until September 25, 1975.
Barnett’s assurance to Southern that the meal was safe
for feed use took place prior to September 19. All twelve
railears had been shipped from Planters by the time the
Barrow-Agee report was issued. Barnett could not have
been relying on the Barrow-Agee report when he misled
Southern because the report was not yet in existence.

10a

Opinion of the United States Court of Appeals
for the Fifth Circuit

The argument that Barnett acted in good faith cannot,
on this record, be sustained.

C. Judicial Notice of the Absence of Tolerance Standards

[6] At the close of the government’s proof in rebuttal,
and at the continued behest of the prosecution, the District
Court told the jury:

Now, members of the jury, the court takes judicial
notice that no regulations prescribed by any govern-
mental agency provide for standards or tolerances
relating to the presence of mercury, PCNB, and
disyston as components, as allowable components, to
be contained in cottonseed meal manufactured and
intended to be used for animal feed, that there are
no regulations on the subject that have been pre-
scribed allowing the presence of these elements in

te meal intended for consumption in animal
eed.

On cross-examnation of government witnesses, the de-
fendants attempted to create the impression that there is
a government-authorized tolerance level for mercury,
PCNB, and disyston. They never proffered evdence of
any such tolerances but they repeatedly cross-examined
government witnesses as to whether there were such stand-
ards. At one point, pursuant to the government’s request
the Court directed defense counsel to present the tolerance
standards if they were available. Barnett’s counsel re-
sponded that he only had “some notes” but wanted to ask
some questions concerning tolerances “for the later tes-
timony”. The Court permitted him to continue.

lla

Opinion of the United States Court of Appeals
for the Fifth Circut

At the conclusion of the expert testimony, the govern-
ment moved the Court to take judicial notice of the ab-
sence of tolerances because “it has been made an issue of
fact on some of the cross-examination.” Barnett’s counsel
protested on the ground that “it was clear the [Knviron-
mental Protection Agency] does in fact have guidelines.”
The Court deferred ruling until it could examine the regu-
lations. At the conclusion of the government’s case-in-chief
the government again moved the Court to take the desired
judicial notice. An extended discussion ensued in cham-
bers. The Court again deferred ruling. During a week-
end recess the Court studied the statutes and regulations
and, after the close of rebuttal proof for the government,
gave the instruction as above quoted.

In the calmness of judicial review we do not understand
exactly how the trial court allowed the government to pre-
vail in this request that it take judicial notice. The defend-
ants had offered no proof that the tolerance standards
existed. There was nothing to rebut. The defense had a
right to cross-examine the government witnesses in a search
for evidence that such standards might exist, but this was
far from establishing that they did exist. The defendants
having wholly failed to establish the existence of any stand-
ards, it would seem hardly necessary that the Court should
have entered the lists on the side of the government by in-
forming the jury at the close of the evidence that, as a mat-
ter of fact, the standards did not exist. If the government
thought that the failure of proof carried with it significantly
adverse consequences, it should have had no real trouble
producing a qualified witness, in chief, who could have tes-
tified that an examination of the Federal Register failed
to reveal the existence of any such standards. All of this
is especially true when it is remembered that it is not neces-

12a

Opinion of the United States Court of Appeals
for the Fifth Circutt

sary for the government to prove a negative, see, e. g.,
Rogers v. United States, 8 Cir. 1966, 367 F.2d 998, cert. de-
nied, 386 U.S. 943, 87 S.Ct. 976, 17 L.Ed.2d 874 (1967).3

We do not approve the procedure followed here, but,
for several reasons, we decline to reverse these convetions
on this point.

In the first place, there is not the slightest contention that
what the District Court told the jury was incorrect. In
the second place, the defendants provoked the situation by
pursuing the point on cross-examination when they knew,
or by investigation of the Federal Register should have
known, there were no such tolerance standards. Lastly,
it may be said that since the statement was true and the
government was under no obligation to prove it in the first
place, the error was harmless beyond a reasonable doubt.

D. Sentencing Procedure

The pre-sentence report contained information relative
to a prior sale by Barnett of soybean meal which had been
processed from beans that had been treated with mercury.
A copy of the report was furnished to Barnett and counsel
prior to sentence. The trial court thoroughly explored the

: “The general principle, and we think the correct one, * * * is that
it 1s not incumbent on the prosecution to adduce positive evidence
to support a negative averment the truth of which is fairly indicated
by established circumstances and which, if untrue, could be readily
Gisproved by the production of documents or other evidence probably
within the defendant’s possession or control. (Cases cited. )”

Rossi v. United States, 1933, 289 U.S. 89, 91-92, 53 S.Ct.
532, 533, 77 L.Ed. 1051, 1052.

13a

Opinion of the United States Court of Appeals
for the Fifth Circuit

subject matter of the report with Jessie P. Barnett, Jr.
and his counsel. Barnett pointed out that there had been
no conviction as a result of this incident, but he did not dis-
pute the basic facts as reported. He claimed that the poi-
soned soybean meal had been mixed with untreated meal
and thereafter shipped to a customer by a third party with-
out Barnett’s consent. Barnett said that he had fully co-
operated with FDA investigators concerning the matter.
Thereupon, the District Court announced that it would re-
quest the probation service to make a further investigation
into the matter and would give further consideration to the
sentence imposed on Count 1 should the Court learn any-
thing “substantially different” within the next thirty days.

Barnett’s counsel subsequently filed a motion for reduc-
tion of sentence. This motion was supported by affidavits
to the effect that the earlier incident occurred through the
nnintentional and unauthorized intermingling of meal proc-
essed from treated beans, with meal processed from un-
contaminated beans.

On December 27, 1977, the District Court denied the mo-
tion on the ground that there was “no basis in fact for the
alteration” requested.

It is undisputed that the sentencing procedure followed
by the District Court was in accordance with the require-
ments of Rule 32(c)(3)(A) of the Federal Rules of Crim-
inal Procedure. Barnett contends, however, that F.R.Crim.
P. 32(c)(3)(A) failed to accord Barnett those safeguards
required as a matter of due process. Specifically, he says
that “consideration of the unsworn accusations of a gov-
ernmental investigative agent over Defendant’s total denial
of such accusations” contravenes the requirements of the
Fifth Amendment to the United States Constitution; that
anything less than a full evidentiary hearing constitutes a
denial of due process.

l4a

Opinion of the United States Court of Appeals
for the Fifth Cireuit

These arguments must be rejected.

{7 A senteneng judge “may appropriately conduct an
inquiry broad in scope, largely unlimited either as to the
kind of information he may consider, or the source from
which it may come.” United States v. Tucker, 404 U.S.
443, 446-47, 92 S.Ct. 589, 30 L.Ed.2d 592 (1972). For
example, in the landmark case of Williams v. New York,
337 U.S. 241, 69 S.Ct. 1079, 93 L.Ed. 1337 (1949), a state
sentencing procedure whereby the judge considered in-
formation obtained “outside the courtroom from persons
whom the defendant has not been permitted to confront
or cross-examine” was found not to be constitutionally
infirm. Jd, at 245. Writing for the Williams Court, Mr.
Justice Black observed that the information necessary for
an

intelligent imposition of sentences would be unavail-
able if information were restricted to that given in
open court by witnesses subject to cross-examina-
tion .. . [such considerations] admonish us against
treating the due process clause as a uniform com-
mand that courts throughout the Nation abandon
their age-old practice of seeking information from
gag sources.... Jd. at 250, 251, 69 S.Ct. at

[8] The Williams Court, of course did not hold that the
sentencing judge’s discretion is unlimited. A defendant
has a right to “at least minimal safeguards to insure that
the sentencing court does not rely on erroneous factual
information”, United States v. Espinoza, 5 Cir. 1973, 481
F.2d 553, 555; see United States v. Tucker, swpra at 447,
92 S.Ct. 589; Townsend v. Burke, 334 U.S. 736, 740, 68
S.Ct. 1252, 92 L.Ed. 1690 (1948). Thus we have held that

15a

Opinion of the United States Court of Appeals
for the Fifth Circuit

where a defendant disputes information considered in im-
posing a sentence, the defendant must be given “at least
some opportunity to rebut that information”, United
States v. Espinoza, swpra at 556; see United States v.
Ashley, 5 Cir., 555 F.2d 462, 466, cert. denied, 484 U.S.
869, 98 S.Ct. 210, 54 L.Ed.2d 147 (1977) ; Shelton v. United
States, 5 Cir. 1974, 497 F.2d 156, 160. See also United
States v. Rollerson, 5 Cir. 1974, 491 F.2d 1209, 1213;
United States v. Battaglia, 5 Cir. 1972, 478 F.2d 854.

[9] The right of rebuttal does not require that the sen-
tencing hearing be transformed into a second trial. See
United States v. Espinoza, supra, at 558. See also United
States v. Weston, 9 Cir. 1971, 448 F.2d 626, 633, cert.
denied, 404 U.S. 1061, 92 S.Ct. 748, 30 L.Ed.2d 749 (1972).
At a minimum it is sufficient if the sentencing judge
affords the defendant an opportunity to “comment on any
alleged factual inaccuracy.” United States v. Brice, 5 Cir.
1977, 565 F.2d 336, 337; United States v. Hodges, 5 Cir.
1977, 547 F.2d 951, 952; United States v. Ashley, supra.

Barnett does not contend that he was not afforded an
opportunity to rebut the information contained in the pre-
sentence report. What he claims is that he “did rebut”
it. He therefore argues that the right of rebuttal was in-
sufficient; “anything less than a full evidentiary hearing
constitutes a denial of due process”. This argument, of
course, is knocked from its feet by Williams v. New York,
supra.

Reliance on Witherspoon v. Illinois, 391 U.S. 510, 88
S.Ct. 1770, 20 L.Ed.2d 776 (1968); Mempa v. Rhay, 389
U.S. 128, 88 S.Ct. 254, 19 L.Ed.2d 336 (1967); and Specht
y. Patterson, 386 U.S. 605, 87 S.Ct. 1209, 18 L.Ed.2d 326
(1967), is misplaced. These cases held that due process
applied to the sentencing stage of a criminal proceeding,

t+ <3. ey i

l6a

Opinion of the United States Court of Appeals
for the Fifth Circuit

but this only begins the due process inquiry, for “[O]nce
it is determined that due process applies, the question
remains what process is due”, Morrissey v. Brewer, 408
U.S. 471, 481, 92 S.Ct. 2593, 33 L.Ed.2d 484 (1972), cited
in Gardner vy. Florida, 430 U.S. 349, 358 n. 9, 97 S.Ct.
1197, 51 L.Ed.2d 393 (1977).

[10] As a matter of due process, a defendant about to
be sentenced is not entitled to the same evidentiary pro-
tections, such as the right ‘to cross-examine adverse wit-
nesses in a sentencing proceeding, as are available in a
trial on guilt or innocence.

[11] In this case, Barnett was fully informed of the
contents of the pre-sentence report. He was given every
opportunity to state his version of the matter, and he
did so. That is the end of it.

ConcLusiIon

The judgments of the District Court, as to all appel-
lants, are

AFFIRMED.

17a

Judgment of the United States Court of Appeals
for the Fifth Circuit

UNITED STATES COURT OF APPEALS
For tue Firrx Circuir
No. 77-5811
D. C. Docker No. CRD77-29-K

Untrep States oF AMERICA,

Plaintiff-A ppellee,

Versus

Jesse P. Barnett, Jr., Barnett & Sons Satvace, Lrp.,
and Bruty D. Hicks,

Defendants-A ppellants.

Appeals from the United States District Court
for the Northern District of Mississippi

Before Coreman, Ciark and Rusry, Circuit Judges.

JUDGMENT

This cause came on to be heard on the transcript of the
record from the United States District Court for the
Northern District of Mississippi, and was argued by coun-
sel;

18a

Judgment of the United States Court of Appeals
for the Fifth Circuit

On Consmeration Wuereor, It is now here ordered
and adjudged by this Court that the judgments of the
said District Court in this cause be, and the same are
hereby, affirmed.

January 8, 1979
Issued As Mandate:

19a

Order Granting Stay of the Issuance of the Mandate

Pending Petition for Writ of Certiorari

IN THE
UNITED STATES COURT OF APPEALS

For tae Firra Circuir
No. 77-5811

Court of Appeals
Filed
Feb 5 1979

Ward W. Wadsworth
Clerk

i.
2

Unirep States oF AMERICA,
Plaintiff-Appellee,

versus

Jesse P. Barnett, Jr., BAnnetr & Sons Sarvace, Lro.
and Butty D. Hicks,

Defendants-A ppellants.

a.
—

Appeals from the United States District Court
for the Northern District of Mississippi

ORDER
The motion of Appellant, Billy D. Hicks for stay of

the issuance of the mandate pending petition for writ of

20a

Order Granting Stay of the Issuance of the Mandate
Pending Petition for Writ of Certiorari

certiorari is Grantep to and including February 15, 1979,
the stay to continue in foree until the final disposition of
the case by the Supreme Court, provided that within the
period above mentioned there shall be filed with the Clerk
of this Court the certificate of the Clerk of the Supreme
Court that the certiorari petition has been filed. The Clerk
shall issue the mandate upon the filing of a copy of an
order of the Supreme Court denying the writ, or upon the
expiration of the stay granted herein, unless the above
mentioned certificate shall be filed with the Clerk of this
Court_within that time.

/s/ James P. CoLteman
United States Circuit Judge

2la

Constitutional Provisions Involved

CoNnSTITUTION
OF THE
Unitep States or AMERICA

AMENDMENT 5

CRIMINAL ACTIONS—PROVISIONS CONCERNING—DUE PROCESS
OF LAW AND JUST COMPENSATION CLAUSES.

No person shall be held to answer for a capital, or other-
wise infamous crime, unless on a presentment or indict-
ment of a Grand Jury, except in cases arising in the land
or naval forces, or in the Militia, when in actual service
in time of War or public danger; nor shall any person
be subject for the same offense to be twice put in jeopardy
of life or limb; nor shall be compelled in any criminal
ease to be a witness against himself, nor be deprived of
life, liberty, or property, without due process of law; nor
shall private property be taken for public use, without
just compensation.

Sec. 9, Cu. 3. Brut oF arrarnDER—EXx POsT FACTO LAWS.
No Bill of Attainder or ex post facto Law shall be passed.

22a

Statutes Involved
Tit. 18, § 2

2. Prrncrpats.—(a) Whoever commits an offense against
the United States or aids, abets, counsels, commands, in-
duces or procures its commission, is punishable as a prin-

cipal.

(b) Whoever willfully causes an act to be done which
if directly performed by him or another would be an of-
fense against the United States, is punishable as a prin-
cipal. (June 25, 1948, c. 645, § 1, 62 Stat. 684; Oct. 31,
1951, c. 655, § 17b, 65 Stat. 717.)

Tit. 18 § 371

Section 371. CoNspPmRAcy TO’ COMMIT OFFENSE OR TO DE-
rkauD Unitep Srares.—If two or more persons conspire
either to commit any offense against the United States,
or to defraud the United States or any agency thereof in
any manner or for any purpose, and one or more of such
persons do any act to effect the object to the conspiracy,
each shall be fined not more than $10,000 or imprisoned
not more than five years, or both.

If, however, the offense, the commission of which is the
object of the conspiracy, is a misdemeanor only, the pun-
ishment for such conspiracy shall not exceed the maxi-
mum punishment provided for such misdemeanor. (June
25, 1948, c. 645, 4 1, 62 Stat. 701.)

ee

23a
Statutes Involved

Tit. 21, § 321
§ 321. Derrnitions—GENERALLY

For the purposes of this Act—

(f{) The term “food” means (1) articles used for food
or drink for man or other animals, (2) chewing gum, and
(3) articles used for components of any such article.

Prouisirep Acts AND PENALTIES

Tit. 21 § 331

§ 331. ProHrpireD acts

The following acts and the causing thereof are hereby
prohibited :

(a) The introduction or delivery for introduction into
interstate commerce of any food, drug, device, or cos-
metic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug,
device, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food,
drug, device, or cosmetic that is adulterated or mis-
branded, and the delivery or proffered delivery thereof
for pay or otherwise.

(d) The introduction or delivery for introduction into
interstate commerce of any article in violation of sec-
tion 404 or 505 [21 USCS § 344, or 355].

(e) The refusal to permit access to or copying of any
record as required by section 703 [21 USCS § 373];
or the failure to establish or maintain any record, or
make any report, required under section 505(i) or (j),

24a
Statutes Involv:d

507(d) or (g), or 512(j), (2), or (m) [21 USCS $§ 355
(i), (j), 357(d), (g), 360b(j), (1) (b)] or the refusal
to permit access to or verification or copying of any
such required record.

(f) The refusal to permit entry or inspection as au-
thorized by section 704 [21 USCS § 374].

Tit. 21 § 333

§ 333. Prnauties

(a) Any person who violates a provision of section 301
[21 USCS § 331] shall be imprisoned for not more than
one year or fined not more than $1,000 or both.

(b) Notwithstanding the provisions of subsection (a) of
this section, if any person commits such a violation after
a conviction of him under this section has become final,
or commits such a violation with the intent to defraud
or mislead, such person shall be imprisoned for not more
than three years or fined not more than $10,000 or both.

Tit. 21 ¢ 342

§ 342. ApULTERATED FOOD

A food shall be deemed to be adulterated—

(a) Poisonous, insanitary, or deleterious ingredients. (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)
(A) if it bears or contains any added poisonous or

25a
Siatutes Involved

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 [21 USCS § 346], or (B) if it
is a raw agricultural commodity and it bears or con-
tains a pesticide chemical which is unsafe within the
meaning of section 408(a) [21 USCS § 346a(a)], or
(C) if it is, or it bears or contains any food additive
which is unsafe within the meaning of section 409 [21
USCS § 348]: Provided, That where a pesticide chemi-
cal has been used in or on a raw agricultural commodity
in conformity with an exemption granted or a tolerance
prescribed under section 408 [21 USCS § 346a] and
such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehy-
drating, or milling, the residue of such pesticide chemi-
cal remaining in or on such processed food shall, not-
withstanding the provisions of sections 406 and 409 [21
USCS §§ 346, 348], not be deemed unsafe if such resi-
due 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 agriculture commod-
. ae

Tit. 21 § 343

§ 343. MisBraNDED FOOD

A food shall be deemed to be misbranded—

(a) False or misleading label. If its labeling is false or
misleading in any particular,

26a
Statutes Involved

Tit. 21 § 346a

§ 346a. ToLERANCES FOR PESTICIDE CHEMICALS IN OR ON
RAW AGRICULTURAL COMMODITIES

(a) Any poisonous or deleterious pesticide chemical, or
any pesticide chemical which is not generally recognized,
among experts qualified by scientific training and experi-
ence 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) [21 USCS § 342(a)(2)] un-
less—

(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 agricul-
tural commodity, such raw agricultural commodity shall
not, by reason of bearing or containing any added amount
of such pesticide chemical, be considered to be adulter-
ated within the meaning of clause (1) of section 402(a)
[21 USCS § 342(a)(1)].

(b) The Secretary shall promulgate regulations establish-
ing tolerances with respect to the use in or on raw agri-
cultural commodities of poisonous or deleterious pesticide

27a
Statutes Involved

chemicals and of pesticide chemicals which are not gen-
erally 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 pro-
tect the public health. In establishing any such regulation,
the Secretary shall give appropriate consideration, among
other relevant factors, (1) to the necessity for the pro-
duction of an adequate, wholesome, and economical food
supply; (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 epinion of the Secretary of Agriculture as
submitted with a certification of usefulness under subsec-
tion (l) of this section. Such regulations shall be promul-
gated in the manner prescribed in subsection (d) or (e)
of this section. In carrying out the provisions of this sec-
tion relating to the establishment of tolerances, the Secre-
tary may establish the tolerance applicable with respect
to ihe 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.

(ec) 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 com-
modities 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 sub-
mitted an application for the registration of, an economic
poison under the Federal Insecticide, Fungicide, and
Rodenticide Act [7 USCS 4$§ 121-134 note, 135 and notes

28a
Statutes Involved

—135k] may file with the Secretary of Health, Educa-
tion, and Welfare, a petition proposing the issuance of
a regulation establishing a tolerance for a pesticide chem-
ical which constitutes, or is an ingredient of, such eco-
nomic poison, or exempting the -pesticide chemical from
the requirement of a tolerance. The petition shall con-
tain 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 re-
maining, including a description of the analytical meth-
ods 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 Sec-
retary within thirty days after filing. Such notice shall
include the analytical methods available for the deter-
mination of the residue of the pesticide chemical! for
which a tolerance or exemption is proposed.

(2) Within ninety days after a certification of useful-
ness by the Secretary of Agriculture under subsection
(1) with respect to the pesticide chemical shall after

29a
Statutes Involved

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 chem-
ical named in the petition for the purposes for which
it is so certified as useful, or

(B) exempting the pesticide chemical from the neces-
sity 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 re-
quests, within ninety days after a certification of useful-
ness 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 com-
mittee, or in the event the Secretary of Health, Educa-
tion, and Welfare within such period otherwise deems
such referral necessary, the Secretary of Health, Edu-
cation, 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 inde-
pendent study of the data submitted to it by the Secre-
tary and other data before it, certify to the Secretary a
report and recommendations on the proposal in the pe-
tition to the Secretary, together with all underlying data
and a statement of the reasons or basis for the recom-

30a
Statutes Involved

mendations. The sixty-day period provided for herein
may be extended by the advisory committee for an addi-
tional 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, reeommen-
dations, underlying data, and statement, by order make
public a regulation—

(A) establishing a tolerance for the pesticide chem-
ical named in the petition for the purposes for which
it is so certified as useful; or

(B) exempting the pesticide chemical from the neces-
sity 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 ad-
versely 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 See-
retary, specifying with particularity the provisions of the
regulation deemed objectionable, stating reasonable
grounds therefor, and requesting a public hearing upon
such objection. A copy of the objections filed by a per-
son other than the petitioner shall be served on the peti-
tioner, if the regulation was issued pursuant to a peti-
tion. 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 objection. Any report, rec-
ommendations, underlying data, and reasons certified to
the Secretary by an advisory committee shall be made a

OR a a Nn eo

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part of the record of the hearing, if relevant and ma-
terial, subject to the provisions of section 7(c) of the
Administrative Procedure Act (5 U.S. C. see. 1006(¢)).
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 rec-
ommendations 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 a public regulation.
Such regulation shall be based only on substantial evi-
dence 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 regula-
tion is based. No such order shall take effect prior to
the ninetieth day after its publication, unless the Sec-
retary finds that emergency conditions exist necessitat-
ing an earlier effective date, in which event the Secretary
shall specify in the order of his findings as to such con-
ditions.

(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 pesti-
cide chemical or exempting it from the necessity of a tol-
erance. 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 In-

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secticide, Fungicide, and Rodenticide Act [7 USCS §§ 121-
134 note, 135 and notes—135k] containing the pesticide
chemical named in the proposal, requests that the proposal
he referred to an advisory committee. In the event of such
a request, the Secretary shall forthwith submit the pro-
posal 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 re-
ferral, but not later than sixty days thereafter, unless ex-
tended as hereinafter provided, the committee shall, after
independent study of the data submitted to it by the See-
retary 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 deem this necessary. Within thirty days after
such certification, the Secretary may, after giving due con-
sideration to all data before him, including such report,
recommendations, underlying data and statement, by order
publish a regulation establishing a tolerance for the pesti-
cide chemical named in the proposal or exempting it from
the necessity of a tolerance which shall become effective
upon publication. Regulations issued under this subsec-
tion shall upon publication be subject to paragraph (5) of
subsection (d).

(f) All data submitted to the Secretary or to an advis-
ory 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 re-
vealed to any person other than those authorized by the

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Secretary or by an advisory committee in the carrying
out of their official duties under this section.

(¢) 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 com-
petent 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 Na-
tional 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. Mem-
bers of an advisory committee shall receive compensation
and travel expenses in accordance with subsection (b)(5)
(D) of section 706 [21 USCS § 376]. 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 procedure to be fol-
lowed by the committee.

(h) A person who has filed a petition or who has re-
quested the referral of a proposal to an advisory com-
mittee in accordance with the provisions 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
(gz) in connection with the petition or proposal.

(i) (1) In a ease 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

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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 sixty days after the 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 ques-
tions of fact shall be sustained if supported by substan-
tial 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

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substantial evidence when considered on the record as
a whole.

(4) If application is made to the court for leave to ad-
duce additional evidence, the court may order such ad-
ditional evidence to be taken before the Secretary of
fleaith, Edueation 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 evi-
dence is material and there were reasonable grounds for
failure to adduce such evidence in the proceedings be-
low. 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 sec-
tion shall not, unless specifically ordered by the court
to the contrary, operate as a stay of an order. The
courts shall advance on the docket and expedite the dis-
position of all causes filed therein pursuant to this sec-
tion.

(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 [7 USCS §§ 121-134 note, 135 and notes—
135k] or upon his own initiative, establish a temporary
tolerance for the pesticide chemical for the uses covered

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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 toler-
ance. 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 limtied hazard to the public health in-
volved in such work when conducted in accordance with
applicable regulations under the Federal Insecticide,
TFungicide, and Rodenticide Act [7 USCS §§ 121-134 note,
135 and notes-135k].

(k) Regulations affecting pesticide chemicals in or on raw
agricultural commodities which are promulgated under the
authority of section 406(a) [21 USCS § 346(a)] upon the
basis of public hearings instituted before January 1, 1953,
in accordance with section 701(e) [21 USCS § 371(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 per-
son who has registered, or who has submitted an applica-
tion for the registration of, an economic poison under the
Federal Insecticide, Fungicide, and Rodenticide Act [7
USCS §§ 121-134 note, 135 and notes—135k], 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 eco-
nomic 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 postpone action for
such period, on the basis of data before him, either—

(1) certify to the Secretary of Health, Education, and
Welfare that such pesticide chemical is useful for the

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purpose for which a tolerance or exemption is sought; or
(2) notify the person requesting the certification of his
proposal to certify that the pesticide chemical does not
appear to be useful for the purpose for which a tolerance
or exemption is sought, or appears to be useful for only
some of the purposes for which a tolerance or exemption
is sought.

In the event that the Secretary of Agriculture takes the
action described in clause (2) of the preceding sentence,
the person requesting the certification, within one week
after receiving the proposed certification, may either (A)
request the Secretary of Agriculture to certify to the Sec-
retary of Health, Education, and Welfare on the basis of
the proposed certification; (B) request a hearing on the
proposed certification or the parts thereof objected to; or
(C) request both such certification and such hearing. If
no such action is taken, the Secretary may by order make
the certification as proposed. In the event that the action
described in clause (A) or (C) is taken, the Secretary shall
by order make the certification as proposed with respect
to such parts thereof as are requested. It [In] the event a
hearing is requested, the Secretary of Agriculture shall
provide opportunity for a prompt hearing. The certifica-
tion of the Secretary of Agriculture as the result of such
hearing shall be made by order and shall be based only on
substantial evidence of record at the hearing and shall set
forth detailed findings of fact. In no event shall the time
elapsing between the making of a request for a certification
under this subsection and final certification by the Secre-
tary of Agriculture exceed one hundred and sixty days.
The Seccetary shall submit to the Secretary of Health,
Education, and Weifare with any certification of usefulness
under this subsection an opinion, based on the data before
him, whether the tolerance or exemption proposed by the

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petitioner reasonably reflects the amount of residue likely
to result when the pesticide chemical is used in the manner
proposed for the purpose for which the certification is
made. The Secretary of Agriculture, after due notice and
opportunity for public hearing, is authorized to promul-
gate rules and regulations for carrying out the provisions
of this subsection.

(m) The Secretary of Health, Education, and Welfare
shall prescribe by regulations the procedure by which reg-
ulations under this section may be amended or repealed,
and such procedure shall conform to the procedure pro-
vided in this section for the promulgation of regulations
establishing tolerances, including the appointment of ad-
visory committees and the procedure for referring petitions
to such committees.

(n) The provisions of section 303(c) of the Federal Food,
Irug, and Cosmetic Act [21 USCS § 333(¢c)] with respect
to the furnishing of guaranties shall be applicable to raw
agricultural commodities covered by this section.

(o) The Secretary of Health, Education, and Welfare shall
by regulation require the payment of such fees as will in
the aggregate, in the judgment of the Secretary, be suffi-
cient over a reasonable term to provide, equip, and main-
tain an adequate service for the performance of the Secre-
tary’s functions under this section. Under such regulations,
the performance of the Secretary’s services or other func-
tions pursuant to this section, including any one or more
of the following, may be conditioned upon the payment of
such fees: (1) The acceptance of filing of a petition sub-
mitted under subsection (d); (2) the promulgation of a
regulation establishing a tolerance, or an exemption from
the necessity of a tolerance, under this section, or the

39a
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amendment or repeal of such a regulation; (3) the referral
of a petition or proposal under this section to an advisory
committee; (4) the acceptance for filing of objections under
subsection (d)(5); or (5) the certification and filing in
court of a transcript of the proceedings and the record
under subsection (i)(2). Such regulations may further
provide for waiver or refund of fees in whole or in part
when in the judgment of the Secretary such waiver or
refund is equitable and not contrary to the purposes of
this subsection.

Tit. 21 § 348

§ 348. Foop appITIVEs

(a) Unsare Foop appitives. A food additive shall, with
respect to any particular use or intended use of such addi-
tives, be deemed to be unsafe for the purposes of the ap-
lication of clause (2)(C) of section 402(a) [21 USCS
§ 342(a)(2)(C)], unless—

(1) it and its use or intended use conform to the terms
of an exemption which is in effect pursuant to subsection
(i) of this section; or

(2) there is in effect, and it and its use or intended use
are in conformity with, a regulation issued under this
section prescribing the conditions under which such
additive may be safely used.

While such a regulation relating to a food additive is in
effect, a food shall not, by reason of bearing or contain-
ing such an additive in accordance with the regulation,
be considered adulterated within the meaning of clause
(1) of section 402(a) [21 USCS § 342(a)(1)].

40a
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(b) PrtrTion TO ESTABLISH SAFETY. (1) Any person may,
with respect to any intended use of a food additive, file
with the Secretary a petition proposing the issuance of
a regulation prescribing the conditions under which such
additive may be safely used. -

(2) Such petition shall, in addition to any explanatory
or supporting data, contain—

(A) the name and all pertinent information concern-
ing such food additive, including, where available, its
chemical identity and composition;

(B) a statement of the conditions of the proposed use
of such addit've, including all directions, reeommenda-
tions, and suggestions proposed for the use of such
additive, and including specimens of its proposed
labeling ;

(C) all relevant data bearing on the physical or other
technical effect such additive is intended to produce,
and the quantity of such additive required to produce
such effect;

(D) a description of practicable methods for deter-
mining the quantity of such additive in or on food,
and any substance formed in or on food, because of
its use; and

(E) full reports of investigations made with respect
to the safety for use of such additive, including full
information as to the methods and controls used in
conducting such investigations.

(3) Upon request of the Secretary, the petitioner shall
furnish (or, if the petitioner is not the manufacturer
of such additive, the petitioner shall have the manu-
facturer of such additive furnish, without disclosure to

Se ee ee ee eee eaten a

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the petitioner) a full description of the methods used in,
and the facilities and controls used for, the production
of such additive.

(4) Upon request of the Secretary, the petitioner shall
furnish samples of the food additive involved, or articles
used as components thereof, and of the food in or on
which the additive is proposed to be used.

(5) Notice of the regulation proposed by the petitioner
shall be published in general terms by the Secretary
within thirty days after filing.

(ec) AcTIOoN ON THE PETITION. (1) The Secretary shall—

(A) by order establish a regulation (whether or not in
accord with that proposed by the petitioner) prescrib-
ing, with respect to one or mo-2 proposed uses of the
food additive involved, the conditions under which
such additive may be safely used (including, but not
limited to, specifications as to the particular food or
classes of food in or in which such additive may be
used, the maximum quantity which may be used or
permitted to remain in or on such food, the manner
in which such additive may be added to or used in or
on such food, and any directions or other labeling or
packaging requirements for such additive deemed nec-
essary by him to assure the safety of such use), and
shall notify the petitioner of such order and the rea-
sons for such action; or

(B) by order deny the petition, and shall notify the
petitioner of such order and of the reasons for such
action.
(2) The order required by paragraph (1)(A) or (B) of”
this subsection shall be issued within ninety days after

42a
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the date of filing of the petition. except that the Secre-
tary may (prior to such ninetieth day), by written no-
tice to the petitioner, extend such ninety-day period to
such time (not more than one hundred and eighty days
after the date of filing of the petition) as the Secretary
deems necessary to enable him to study and investigate
the petition.

(3) No such regulation shall issue if a fair evaluation
of the data before the Secretary—

(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified
in the regulation, will be safe: Provided, That no ad-
ditive shall be deemed to be safe if it is found to in-
duce cancer when ingested by man or animal, or if it
is found, after tests which are appropriate for the
evaluation of the safety of food additives, to induce
cancer in man or animal, except that this proviso shall
not apply with respect to the use of a substance as an
ingredient of feed for animals which are raised for
food production, if the Secretary finds (i) that, under
the conditions of use and feeding specified in proposed
labeling and reasonably certain to be followed in prac-
tice, such additive will not adversely affect the animals
for which such feed is intended, and (ii) that no resi-
due of the additive will be found (by methods of ex-

' amination prescribed or approved by the Secretary by
regulations, which regulations shall not be subject to
subsections (f) and (g) in any edible portion of such
animal after slaughter or in any food yielded by or
derived from the living animal; or

(B) shows that the proposed use of the additive would
promote deception of the consumer in violation of this
Act or would otherwise result in adulteration or in mis-
branding of food within the meaning of this Act.

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(4) If, in the judgment of the Secretary, based upon a
fair evaluation of the data before him, a tolerance limita-
tion is required in order to assure that the proposed use
of an additive will be safe, the Secretary—

(A) shall not fix such tolerance limitation at a level
higher than he finds to be reasonably required to ac-
complish the physical or other technical effect for which
such additive is intended; and

(B) shall not establish a regulation for such proposed
use if he finds upon a fair evaluation of the data be-
fore him that such data do not establish that such use
would accomplish the intended physical or other tech-
nical effect.

(5) In determining, for the purposes of this section,
whether a proposed use of a food additive is safe, the
Secretary shall consider among other relevant factors—

(A) the probable consumption of the additive and of
any substance formed in or on food because of the use
of the additive;

(B) the cumulative effect of such additive in the diet
of man or animals, taking into account any chemically
or pharmacologically related substance or substances
in such diet; and

(C) safety factors which in the opinion of experts qual-
ified by scientific training and experience to evaluate
the safety of food additives are generally recognized
as appropriate for the use of animal experimentation
data.

(d) ReauLation IssuED oN SEcRETARY’s INITIATIVE. The
Secretary may at any time, upon his own initiative, pro-
pose the issuance of a regulation prescribing, with re-

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spect to any particular use of a food additive, the con-
ditions under which such additive may be safely used,
and the reasons therefor. After the thirtieth day follow-
ing publication of such a proposal, the Secretary may by
order establish a regulation based upon the proposal.

(e) PUBLICATION AND EFFECTIVE DATE OF ORDERS. Any order,
including any regulation established by such order, is-
sued under subsection (c) or (c.) of this section, shall be
effective upon publication, but the Secretary may stay
such effectiveness if, after issuance of such order, a hear-
ing is sought with respect to such order pursuant to sub-
section (f).

(£) OpsEcTIONS AND PUBLIC HEARING. (1) Within thirty
days after publication of an order made pursuant to
subsection (c) or (d) of this section, any person ad-
versely affected by such an order may file objections
thereto with the Secretary, specifying with particularity
the provisions of the order deemed objectionable, stating
reasonable grounds therefor, and requesting a public
hearing upon such objections. The Secretary shall,
after due notice, as promptly as possible hold such
public hearing for the purpose of receiving evidence
relevant and material to the issues raised by such ob-
jections. As soon as practicable after completion of
the hearing, the Secretary shall by order act upon such
objections and make such order public.

(2) Such order shall be based upon a fair evaluation
of the entire reeord at such hearing, and shall inelude
a statement setting forth in detail the findings and con-
clusions upon which the order is based.

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(3) The Seeretary shall specify in the order the date on
which it shall take effect, except that it shall not be
made to 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.

(g) JuprctaL review. (1) In a ease of actual controversy
as to the validity of any order issued under subsection
(f), including any order thereunder with respect to
amendment or repeal of a regulation issued under this
section, 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 busi-
ness, or in the United States Court of Appeals for the
District of Columbia Cireuit, within sixty days after
the entry of such order, a petition praying that the
order be set aside in whole or in part.

(2) A copy of such petition shall be forthwith trans-
mitted by the clerk of the court to the Secretary, or any
officer designated by him for that purpose, and there-
upon the Secretary shall file in the court the record of
the proceedings on which he based his order, as pro-
vided in section 2112 of title 28, United States Code.
Upon the filing of such petition the court shall have
jurisdiction, which upon the filing of the record with it
shall be exclusive, to affirm or set aside the order com-
plained of in whole or in part. Until the filing of the
record the Secretary may modify or set aside his order.

(3) The court, on such judicial review, shall not sus-
tain the order of the Secretary if he failed to comply

46a
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with any requirement imposed on him by subsection (f)
(2) of this section.

(4) If application is made to the court for leave to ad-
duce additional evidence, the court may order such ad-
ditional evidence to be taken before the Secretary and
to be adduced upon the hearing in such manner and
upon such terms and conditions as the court may seem
proper, if such evidence is material and there were rea-
sonable grounds for failure to adduce such evidence in
the proceedings below. The Secretary may modify his
findings as to the facts and order by reason of the ad-
ditional 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 sec-
tion shall not, unless specifically ordered by the court to
the contrary, operate as a stay of an order.

(h) AMENDMENT OR REPEAL OF REGULATIONS. The Secretary
shall by regulation prescribe the procedure by which regu-
lations under the foregoing provisions of this seztion may
be amended or repealed, and such procedure shall con-
form to the procedure provided in this section for the
promulgation of such regulations.

(i) EXEMPTIONS FOR INVESTIGATIONAL USE. Without regard
to subsections (b) to (h), inclusive of this section, the
Secretary shall by regulation provide for exempting from
the requirements of this section any food additive, and

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any food bearing or containing such additive, intended
solely for investigational use by qualified experts when in
his opinion such exemption is consistent with the public
health.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385005_2486%3A1. Public record. Not legal advice.