# Petition — Articles of Food v. United States

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition
- **Published:** January 1, 1979
- **Citation:** 444 U.S. 832

## Text

In The

Supreme Court of the United States

October Term, 1978

8)
a

No. ¥. 3.2] 7 2 §

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UNITED STATES OF AMERICA,

Respondent,
timing”

eee ee a
ne

ARTICLES OF FOOD, ETC., ROBERT NIELSEN
d/b/a GRUMPY’S BUFFALO JERKY CO.,

Petitioner.
es

4
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PETITION FOR A WRIT OF CERTIORARI TO
THE UNITED STATES COURT OF APPEALS
FOR THE EIGHTH CIRCUIT

JEFFREY A. SILVER

2424 South 130th Circle
Omaha, Nebraska 68144
(402) 330-3800

Attorney for Petitioner

COCKLE PRINTING CO., 2311 Douglas St., Omaha 68102

Ali

TABLE OF CONTENTS

Pages
EO I i a a 2
ROE SARE SOR ee MEE LOA I AE EES > 2
NI a i siediinerniallbhceaceons 2
Statutory Provisions Involved ................
Miscellaneous cco 3
Sees OE See COND ce isk. 3
Statement of Facts lg 4
Proceedings Below ................. ERS Seino aie a ire a Ca 5

Reasons for Granting the Writ:

I. This Court should issue a writ of certiorari to
decide whether sodium nitrate and sodium ni-
trite are food additives within the definition of
21 U.S.C. Seetion 342 (a) (2) (ce). 6

II. This Court should issue a writ of certiorari to
decide the relationship and jurisdiction of the
Food and Drue Administration and Department
of Agriculture over bison meat. ..... 11

III. This Court should issue a writ of certiorari to
review the Court of Appeals’ holding that sodium
nitrate and sodium nitrite are not generally
recognized as safe in conjunction with processing

een Gee 14
a hd uals eladinnnl nc ogaacetebschethddesala 17
Appendix A App. 1
Appendix B. ............ SR ee a App. 10

Appendix C Pub sah oiace> cepaakendiajuhenteedtatiiiaonde App. 12

il

TABLE OF AUTHORITIES

Pages

CASES:
Chip Steak Co. v. Hardin, 332 F. Supp. 1084 (D.C.

6 5} ieee sc fall A ict coal co) 9,12
Srlenbaugh vy. U.S., 409 U.S. 289, 34 L. Ed. 446,

Se ec I i celica 10
Fortnightly Corp. v. United Artists ‘Television,

ga aR aC Mrs <a a 13
Investment Annuity, Ine. v. Blumenthal, 442 F.

Supp. 681 (D. D.C. 1977) - 12
Jerome H. Remiek and Co, v. American Automobile

Accessories Co., 5 F.2d 411 (6th Cir.) fo. =6«18
National Petroleum Refiners Association v. ETC,

482 F.2d 672 (D.C. Cir.) 13
Northeross v. Board of Mdueation of Memphis

City Schools, 412 U.S. 427, 87 L. Hd. 2d 48, 98

S.Ct. 2201 (1973) 10
Sehueck v. Butz, 500 F.2d 810 (D.C. Cir. 1974) oo... 15
United Shoe Workers of America AFL-CIO vy.

Bedell, 506 F. 2d 174 (D.C. Cir, 1974) 2... 12
United States of America v. Naremeo, Ine., 553

POR OR Rf | eT
STATUTES :
te i ees I SO, este 3
9 C.F. BR. Section 301.2 et seq. nnnn.cccceecccecmsccssnnnne slsadiabets 11
ek re NI IE sheen cece, 6,7

ili

TABLE OF AUTHORITIES—Continued

Pages
9 C. F.R. Section 318.7 (e) (10) uu... 8, 11,15
BE Fs Tic SIRI: RCI wiccissiccserticey ine aloneetresctcanicneniaiibonn 15
SR Gh. Be a Ce acti Scien ae
R U8. eee See Cs eee
21 U.S.C. Section 321 (s) ———__.___.. 2, 5, 6, 7, 8, 9, 11, 14, 16
3 0.3: C. Sestion ae1 fa) (8) wee
21 U.S.C. Section 342 (a) (2) (@) nnn. 2, 4, 5, 6, 7, 10, 11
a1. &.6.C. as Dae (en Ca eee oe
21 U.S.C. Section 348 (i) (1) ....... 4
21 U.S.C. Seetion 348 | 5, 9
21 U.S.C. Section 601 et seq. WW... piensdandesoal 3, 5, 7, 8, 11, 14
a U.S. G. Sentiom Gee teh) (3) (6) ee 8,9
TEXT:
Webster’s Third New International Dictionary
IY ‘Sccrdcinioncticsnedcesdesetndeesidadietaaes sedidearadihlctciati 12

In The

Supreme Court of the United States

October Term, 1978

o

UNITED STATES OF AMERICA,
Respondent,
vs.

ARTICLES OF FOOD, ETC., ROBERT NIELSEN
d/b/a GRUMPY’S BUFFALO JERKY CO.,

Petitioner.

PETITION FOR A WRIT OF CERTIORARI TO
THE UNITED STATES COURT OF APPEALS
FOR THE EIGHTH CIRCUIT

~{).
Mw

Robert Nielsen d/b/a Grumpy’s Buffalo Jerky Co.,
Petitioner herein, respectfully prays that a writ of Certi-
orari issue to review the judgment and opinion of tle
United States Court of Appeals for the Eighth Circuit
(Court of Appea!s) entered in these proceedings on Jan-
uary 16, 1979.

2
OPINIONS BELOW

The opinion of the District Court for the District of
Nebraska (District Court) is reported at 456 F. Supp. 207
(D. Neb. 1978) and is reproduced in Appendix A hereto
along with the District Court’s unreported order. The
opinion of the Court of Appeals is unreported but is re-
produced in Appendix B hereto.

}

JURISDICTION

The judgment of the Court of Appeals was entered on
January 16, 1979. The time for filing a Petition for Certi-
orari was extended to May 16, 1979, by order of Mr. Justice
Blackmun dated April 18, 1979. The jurisdiction of this
Court is invoked under 28 U.S. C. Seetion 1254 (1).

)

QUESTIONS PRESENTED

1. Whether the Court of Appeals in alfirming the
judgment of the District Court erred in concluding that the
food product involved in the case at bar is adulterated
within the meaning of 21 U.S. C. Section 342 (a)(2)(e) for
the reason that said food product contains food additiyes
as defined in 21 U.S. C. Section 321 (s), to-wit, sodium ni-
trate and sodium nitrite.

2. Whether the Court of Appeals in affirming the
judgment of the District Court erred in concluding that

3

bison meat is not within the purview of the Meat Inspection
Act, 21 U.S. C. Section 601 et. seq.

3. Whether the Court of Appeals in affirming the
judgment of the District Court erred in holding that
sodium nitrate and sodium nitrite are not generally
recognized as safe in conjunction with processing bison
meat.

STATUTORY PROVISIONS INVOLVED

1. Federal Food, Drug and Cosmetie Act, 21 U.S.C.
Section 301 et. seq. Pertinent provisions of this statute
are set forth in Appendix C, infra.

2. Meat Inspection Act, 21 U.S.C. Section 601 et.
seq. Pertinent provisions of this statute are set forth in
Appendix C, infra.

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MISCELLANEOUS

1. 9C.F.R. Section 301 et. seq. Pertinent provisions
of these regulations are set forth in Appendix C.

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STATEMENT OF THE CASE

Respondent initiated this action to seize and condemn
certain food products as being adulterated pursuant to the
Federal Food, Drug and Cosmetic Act (herein called
** Act”), 21 U.S. C. Section 301 et. seq. Respondent alleged

that the food product, commonly known as “Buffalo Jerky”
was adulterated within the meaning of the Act, 21 U.S.C.
Section 342 (a)(2)(¢), and 21 U.S.C. Section 342(b) (2)
in that the food product ‘‘Buffalo Jerky’’ contained in-
gredients, to-wit, sodium nitrate and sodium nitrite, and
that plant proteins, textured vegetable protein and hydro-
lyzed vegetable protein, as well as water and monosodium
glutamate, were substituted for buffalo (bison) meat. Re-
spondent further alleged that the food product, ‘‘ Buffalo
Jerky’’ was misbranded within the meaning of the Act, 21
U.S.C. Section 343 (i)(1), in that the names “Buffalo
Jerky” and ‘‘ Buffalo Chips” was not the common or usual
name for a product composed of buffalo meat (bison),
water, plant proteins, preservatives, and other ingredients.

Petitioner intervened in the proceeding by filing a
claim for the food product. Both Respondent and Peti-
tioner moved for summary judgment. The District Court,
pursuant to a stipulation of fact and alfidaviis, susiained
Respondent’s motion for summary judgment and overruled
Petitioner’s motion for summary judgment.

~~ ———_—— — --- -()-——— - -

STATEMENT OF FACTS

The parties stipulated that there existed at York, Ne-
braska, in possession of Petitioner, food products consist-
ing of dark brown colored patties with the following ingre-
dients: buffalo (bison) meat, textured vegetable proteins,
hydrolyzed vegetable proteins, salt, spices, flavorings, so-
dium erythorbate, sodium nitrate, sodium nitrite, potas-
sium sorbate, as well as water and monosodium glutamate,

5

and bearing the names ‘‘Buffalo Jerky’’ and ‘‘ Buffalo

Chips’’.

PROCEEDINGS BELOW

Respondent commenced this lawsuit by filing a com-
plaint for forfeiture in the District Court on October 3,
1978, seeking condemnation of the food product “Buffalo
Jerky’’. Petitioner intervened in the litigation and filed
an answer denying the allegations in Respondent’s com-
plaint.

On the basis of the stipulation of fact and aeccompany-
ing affidavits, the District Court entered an Order on July
12, 1978, sustaining Respondent’s motion for summary
judgment and denying Petitioner’s motion for summary
judgment.

In a memorandum ef decision accompanying the order
(see Appendix A) the District Court first found that so-
dium nitrate and sodium nitrite were ‘‘food additives’’
within the meaning of 21 U.S.C. Section 321 (s).

The District Court next determined that bison meat is
not within the purview of the Meat Inspection Act, 21

U.S.C. Section 601 et. seq.

Finally, the District Court determined that sodium
nitrate and sodium nitrite, being food additives within the

, meaning of 21 U.S.C. Section 342 (a)(2)(¢), were unsafe

within the meaning of 21 U.S. C. Section 348. The District
Court concluded that the food product was adulterated

within the meaning of 21 U.S. C. Section 342 (a)(2)(¢e) and
thus subject to seizure and condemnation.

The District Court having determined that the food
products were adulterated did not reach the Respondent’s
alternative allegation of adulteration and misbranding.

The Court of Appeals concluded that the District Court
did not err, and affirmed the judgment on the basis of the
District Court’s opinion. The destruction of the food pro-
ducc has been stayed pending resolution of this Petition
for Certiorari.

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Vv

REASONS FOR GRANTING THE WRIT

This Court should issue a writ of certiorari
to decide whether sodium nitrate and sodium ni-
trite are food additives within the definition of
21 U.S.C. Section 342 (a) (2) (c).

The District Court concluded that sodium nitrate and
sodium nitrite were food additives within the definition of
21 U.S. C. Section 321 (s), and thus the food product which
contained them was adulterated pursuant to 21 U.S.C.
Section 342 (a)(2)(c).

Sodium nitrate and sodium nitrite (commonly known
as salt) have been used since time immemorial to cure
meats and poultry. Reference to the use of nitrates can
be traced back several hundred years and continued after
passage of the Federal Meat Inspection Act. See 9

7

C. F. R. 318, 1975. There can be no doubt that sodiur: ni-
trate and sodium nitrite have been an effective tool in pre-
venting the development of botulism in meat and poultry
products. 9 C.F. R. 318, 1975.

Under 21 U.S. C. Section 342 (a)(2)(c), a food product
is adulterated if it bears or contains any food additive.
**Food Additive’’ is defined in 21 U.S.C. Section 321 (s)
as a substance the intended use of which results or may
reasonably be expected to result, directly or indirectly, in
its becoming a component or otherwise affecting the char-
acteristics of any Food, but does not inelnde any substance
used in accordance with a sanction or approval granted
prior to September 6, 1958, pursuant to the Meat Inspection
Act of March 4, 1907, as amended or extended.

Th.. is apparently a question of first impression and
therefore requires a definitive determination by this Court.

The District Court concluded, albeit erroneously, that
the specific use of the substances sodium nitrate and so-
dium nitrite in bison meat must have been sanctioned by the
Meat Inspection Act, 21 U.S. C. Section 601 et. seq. in order
to come with the exception contained in 21 U.S. C. Section
321 (s) (4). The language of 21 U.S.C. Section 321 (s)
(4) is clear in stating that a food additive does not
include any substance used in accordance with a sanction
or approval granted pursuant to the Meat Inspection Act
of March 4, 1907, as amended and extended. It is not the
food product to which the food additive is added that must
have been approved under the Meat Inspection Act, 21
U.S.C. Section 601, et. seq., but the substance. The sub-
stances in the case at bar are sodium nitrate and sodium
nitrite, not the food product ‘‘ Buffalo Jerky”’.

The use of sodium nitrate and sodium nitrite have been
specifically sanctioned and approved under the Meat In-

spection Act, 21 U.S. C. Section 601, et. seq. Regulations
issued under the Act, 9 C.F. R. Section 318.7 (¢) (10) state
inter alia: .

... the following substances may be added to products:
common salt, approved sugars. .. sodium nitrate, so-
dium nitrite, potassium nitrate, potassiuin nitrite. ..

It is at this point that the question of sodium nitrate
and sodium nitrite being food additives must be deter-
mined. The Distriet Court, however, concluded that in
order for sodium nitrate and sodium nitrite to not be food
additives, further analysis must be made of the food pro-
duet itself, to-wit, “Buffalo Jerky”. This conclusion does
not find support in the specific language of 21 U.S.C.
Section 321 (s)(4), whieh only mandates that the ‘*sub-
stance” must be used with approval under the Meat In-
spection Act, 21 U.S.C. Section 601, et. seq. There is no
limitation contained in 9 C.F.R. Seetion 318.7 (¢)(10)
governing the use of sodium nitrate and sodium nitrite.
The interpretation advanced by Petitioner finds implicit
support in United States of America v. Naremco, Inc., 553
F. 2d 1188 (Sth Cir. 1977). In this ease, the Court in dis-
cussing whether a substance was a food additive within 21
U.S.C. Section 321 (s), limited its discussion to the sub-
stance involved and not the product to which the substance
was added. This interpretation is consistent with the tenor
of 21 U.S.C. Section 321 (s). The District Court erred
in judicially broadening the definition of food additive as
contained in 21 U.S.C. Section 321 (s).

Petitioner’s position is further buttressed by refer-
ence to the Meat Inspection Act, 21 U.S.C. Section 601 et.
seq. Under 21 U.S.C. Section 601 (m)(2)(¢), a product

9

is adulterated ‘‘if it bears or cowixins any food additive
which is unsafe within the meaning of Section 348 of this
title”. In other words, if a substance is declared a food
additive as defined in 21 U.S. C. Section 321 (s), then pur-
suant to 21 U.S.C. Section 348, the substance will then
render the meat or meat food product to which it is added
adulterated within 21 U.S.C. Section 601 (m)(2)(e).

This statutory relationship between the Act and the
Meat Inspection Act fully supports Petitioner’s position
that sodium nitrate and sodium nitrite are not food addi-
tives. In Chip Steak Co. v. Hardin, 332 F. Supp. 1084
(D.C. M.D. Cal. 1971) the Court stated:

The legislative history of the Federal Meat Inspection
Act, as amended, supra, indicates that by the above
provision Congress intended to allow the Secretary
of Agriculture to impose more stringent restrictions
... for food additives ... in or on meat products sub-
ject to the new act than are imposed by the Secretary
of Health, Education, and Welfare under the Federal
Food, Drug and Cosmetie Act. 322 F. Supp. at 1089.

A number of food products available for human con-
sumption contain sodium nitrate and sodium nitrite, and
said products bear the seal ‘‘U. S. inspected and passed by
Department of Agriculture Est. 2862’’. Obviously these
products are not adulterated under the Meat Inspection
Act; however, they do contain sodium nitrate and sodium
nitrite. The only explanation for the products not being
adulterated is that they do not contain food additives,
since a product containing food additives is adulterated
under 21 U.S.C. Section 601 (m) (2) (ce).

According to the District Court, sodium nitrate and
sodium nitrite are food additives. Following this reason-

10

ing to its logical conclusion would render all products on
the market today containing either/or sodium nitrate or
sodium nitrite as adulterated, and thus unfit for human
consumption. A substance cannot be a food additive in a
certain context, and not be a food additive in another con-
text. The term “food additive’’ is contained both in the
Act end the Meat Inspection Act. Both the Act and the
Meat Inspection Act are primarily directed at protecting
the health and welfare of consumers. In Northcross v.
Board of Education of Memphis City Schools, 412 U.S. 427,
o7 L. Ed. 2d 48, 93 S. Ct. 2201 (1973), the Court stated that
statutes containing similar language and sharing common
raison d’etre should be interpreted pari passu. Futher, in
Erlenbaugh v. U.S., 409 U.S. 239, 34 L. Ed. 446, 93 S. Ct.
477 (1972), the Court stated that the concept ‘tin pari

’ is a reflection of practical experience in inter-

materia’
preting statutes: a legislative body generally uses partic-
ular words with consistent meaning in a given context. If
the District Court’s analysis is correct, then food additives
are being treated differently under the Act than under the
Meat Inspection Act, and this is contrary to the well estab-

lished tenets of statutory construction.

In order for the food product ** Buffalo Jerky” to be
adulterated within 21 U.S.C. Section 342 (a)(2)(e), a
food additive must be unsafe. However, if the food pro-
duct does not contain a food additive in the first place, as
in the case at bar, the question of safe or unsafe within 21
U.S. C. Section 342 (a) (2) (e) becomes moot. Since sod-
ium nitrate and sodium nitrite are not food additives, be-
ing within the purview of 21 U.S.C. Section 321 (s) (4),
the food product in which they are contained cannot be
adulterated under 21 U.S.C. Section 342 (a) (2) (ce).

ll

It is important that this Court resolve the apparent
inconsistent treatment afforded to a substance under the
Act and the Meat Inspection Act, and determine when a
substance is or is not a food additive. The evrrent public
controversy surrounding sodium nitrite and sodium ni-
trate further supports the necessity for this Court to re-
view this matter.

II.

This Court should issue a writ of certiorari
to decide the relationship and jurisdiction of the
Food and Drug Administration and Department
of Agriculture over bison meat.

The Court of Appeals affirmed the District Court’s
conclusion that bison meat is not within the purview of the
Meat Inspection Act, 21 U.S. C. Section 601 et. seq. How-
ever, the regulating definitions contained in 9 C. F. R. See-
tion 301.2 et. seq. make it clear that bison meat was included
therein. Clearly, if bison meat is indeed within the regula-
tory scheme of the Meat Inspection Act, 21 U.S.C. See-
tion 601 et. seq., the use of sodium nitrate and sodium ni-
trite is specifically authorized, 9 C.F. R. Section 318.7
(c}(10), thus exempting them from the definition of food
additives contained in 21 U.S.C. Section 321 (s) and pre-
cluding a determination that the product is adulterated
within the meaning of 21 U.S.C. Section 342 (a) (2) (ce).

The statutory scheme of the Meat Inspection Act, 21
U.S. C. Section 601 et. seq. is designed to protect the health
and welfare of consumers by assuring that meat and meat
food products distributed to them are wholesome. The
Meat Inspection Act creates a separate area of concern by

which the Department of Agriculture can impose more
stringent restrictions than under the Act, Chip Steak Co.,
supra.

The Meat Inspection Act regulates foods derived from
cattle, sheep, swine, goats and equines. When the meaning
of a word in a statute is not clear from the statute itself, re-
course may be made to the dictionary. United Shoe
Workers of America AFL-CIO v. Bedell, 506 F. 2d 174
(D. C. Cir. 1974). Webster’s Third New International Dic-
tionary (1966) defines an equine as an animal resembling
a horse. Does not a bison (buffalo) resemble a horse?
Clearly a buffalo is within the definition of equine.

At the time the Meat Inspection Act was adopted, the
re-emergence of bison meat as a viable and less expensive
alternative to other meats had not commenced. Today, the
inexpensive substitute of bison meat and ‘‘beefalo’’ are
realities. ‘l’o conclude that bison meat was not intended
within the regulatory scheme of the Meat Inspection Act
begs the question. This situation was faced by the Court
in Investment Annuity, Inc. v. Blumenthal, 442 F. Supp.
681 (D. D.C. 1977), where the Court stated:

The mere fact that Congress did not consider an as yet
uninvented alternative to a ‘statutorily approved’ ar-
rangement cannot be said to bar application of the
statute to a later-invented alternative if that alterna-
tive is comparable to the ‘approved arrangement’ in
substantially all respects. Defendant’s construction
ignores the generally-accepted canon of statutory con-
struction that where Congress has made a choice of
language which fairly brings a given situation within
a statute, it is unimportant that the particular applica-
tion may not have been contemplated by the legislators.
442 I. Supp. at 689.

13

This Court was faced with a similar question in Fort-
nightly Corp. v. United Artists Television, 392 U.S. 390,
wherein the question of copyright infringement by com-
munity antenna television systems was addressed. The
community television system had not been envisioned by
congress when the copyright statutes had been drafted—
but statutes must be read in light of technological change.
This Court cited, with approval, the following language
from Jerome H. Remick and Co. v. American Automobile
Accessories Co., 5 F. 2d 411 (6th Cir.):

‘While statutes should not be stretched to apply to
new situations not fairly within their scope, they
should not be so narrowly construed as to permit their
evasion because of changing habits due to new inven-
tion and discoveries.’ 392 U.S. at 395.

The fact that bison meat was not specifically included
in the Meat Inspection Act is of no consequence. The
maxim, expressio unius est exclusio alterium is increas-
ingly considered unreliable since it stands on the faulty
premise that all possible alternatives or supplemental pro-
visions were necessarily considered and rejected by the
legislative draftsmen. National Petrolewm Refiners As-
sociation v. FTC, 482 F. 2d 672 (D.C. Cir. 1971).

Congress intended by the Meat Inspection Act to
authorize the Department of Agriculture to assure that
meat and meat by-products would be wholesome. It is
anomalous that sodium nitrate and sodium nitrite are al-
lowed to be added to meat and meat byproducts under the
stricter auspices of the Department of Agriculture, but not
under the Food and Drug Administration. Petitioner sub-
mits that bison meat is, and should be regulated under the
Meat Inspection Act, and that sodium nitrate and sodium

14

nitrite should be exempt from the definitions of food addi-
tive contained in 21 U.S.C. Section 321 (s). The excel-
lence of our jurisprudences is its flexibility to adapt to
change. Does the decision of the Court of Appeals mean
that if a new meat product was developed not within the
statutory guidelines of the Meat Inspection Act, 21 U.S. C.
Section 601 et. seq. it would not be regulated by the Depart-
ment of Agriculture under the Meat Inspection Act. We
think not.

This Court should review this case to clearly delineate
what foods come under the jurisdiction of the Department
of Agriculture and which come under the jurisdiction of the
Food and Drug Administration, with particular emphasis
on bison meat. A substance should not be a food additive
under one federal agency and not a food additive under an-
other federal agency. The only casualty from this inter-
agency battle is Petitioner who is placed in a noncomplying
situation by the disparate treatment of federal agencies.

Il.

This Court should issue a writ of certiorari
to review the Court of Appeals’ holding that
sodium nitrate and sodium nitrite are not gener-
ally recognized as safe in conjunction with proc-
essing bison meat.

This District Court, relying on the conclusory affi-
davits of Samuel I. Shibko and Richard J. Ronk, concluded
that sodium nitrate and sodium nitrite were not generally
recognized as safe in conjunction with the processing of
bison meat. The primary use of both sodium nitrate and
sodium nitrite is a preservative to prevent botulism. The
use to which sodium nitrate and sodivm nitrite are put in
the case at bar is identical.

ae

15

Sodium nitrate and sodium nitrite have been specifie-
ally recognized for use in the curing of certain products, 9
C.F. R. Section 318.7 (c)(10), 21 C.F. R. Section 172.175
and 21 C.F. R. Section 172.170. In addition, the Depart-
ment of Agriculture has approved the use of sodium nitrate
and sodium nitrite in the curing and preserving of products.
In Schuck v. Butz, 500 F. 2d 810 (D.C. Cir. 1974), the
Court stated:

On March 16, 1972, Assistant Secretary Richard Lyng
responded to the Petition in a letter which stated that
the Department would not immediately prohibit all use
of nitrates in meats. He asserted that there was no
convincing evidence that the addition of nitrates to
meat would result in an adulterated product. He also
pointed to evidence that the addition of nitrates may
reduce the dangers of botulism in meat products, and
suggested that a ban on nitrates would eliminate this
benefit, perhaps unnecessarily ... Addition of sodium
nitrate or sodium nitrite within the limits specified in
the regulation, would not result in a product that is
hazardous to human health. 500 F. 2d at 811.

It is inconceivable that agencies of the Federal Govern-
ment would condone the use of substances which were un-
safe. However, that is the tenor of Mr. Shibko’s affidavit,
wherein it is stated:

The potential hazard from the use of these substances
(sodium nitrate and sodium nitrite) in curing some
meats is that the nitrates may result in the formation
of chemical substances known as nitrosaimines which
are known to cause cancer in experimental animals.

Mr. Shibko’s conclusion is paradoxical in view of the ap-
proval by both the Food and Drug Administration and the
Department of Agriculture of the use of sodium nitrate
and sodium nitrite. Since the use to which Petitioner puts

16

said products is identical to the use which has been ap-
proved by the Department of Agriculture, the District
Court’s conclusion rejecting the use of sodium nitrate and
sodium nitrite must of necessity be in error.

The District Court, citing the absence of scientific tes-
timony, concluded that sodium nitrate and sodium nitrite
were not generally recognized as safe. However, the Dis-
trict Court neglected the remainder of 21 U.S.C. Section
321 (s) which states:

... as having been adequately shown through scientific
procedures (or in the case of a substance used in food
prior to January 1, 1958, through either scientific pro-
cedures or experience based on common use in food).
It is clear that both sodium nitrate and sod.um nitrite were
used in food products prior to January 1, 1958, and were
clearly shown to be safe in experience based on common use
in food. The necessity for the showing of scientiic evidence
on the use of sodium nitrate and sodium nitrite was not

necessary in the case at bar.

Petitioner respectfully submits that in disregarding
the clear statutory language of 21 U.S.C. Section 321 (s),
the District Court’s conclusion that sodium nitrate and
sodium nitrite were not generally recognized as safe in con-

junction with processing bison meat was in error.

°

17

CONCLUSION

For the reasons aforesaid, Petitioner prays that a
Writ of Certiorari be granted to review the judgment of
the United States Court of Appeals for the Eighth Circuit.

Respectfully submitted,

ARTICLES OF FOOD, ETC., ROBERT
NIELSEN d/b/a GRUMPY’S
BUFFALO JERKY CO., Petitioner

JEFFREY A. SILVER

2424 South 130th Circle
Omaha, Nebraska 68144
(402) 330-2800

Attorney for Petitioner

App. 1
APPENDIX A

IN THE UNITED STATES DISTRICT COURT FOR
THE DISTRICT OF NEBRASKA

CIV. 77-0-349

UNITED STATES OF AMERICA,
Plaintiff,
vs.

Articles of food consisting of dark brown colored patties
packaged and labeled as follows:

“BUFFALO JERKY * * *’ ete.,
Defendant.

MEMORANDUM OPINION
(Filed July 12, 1978)

The United States of America brought this action
seeking to condemn certain food substances pursuant to the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301,
et. seq. (hereafter referred to as ‘‘the Act’’). The United
States Marshal seized the substances identified in the com-
plaint and the owner intervened to file a claim for return
thereof. Each party filed a motion for summary judgment,
the parties entered into a stipulation of facts (Filing No.
11) and the matter has been submitted for determination
following a hearing.

At issue is a food substance made from the following
ingredients: buffalo (bison) meat, textured vegetable pro-
tein, hydrolyzed vegetable protein, salt, spices, flavoring,
sodium erythorbate, sodium nitrate, sodium nitrite, potas-

App. 2

sium sorbate, water and monosodiuin glutamate (stipula-
tion at Par. 5). These ingredients are combined into dark
brown patties of meat packaged in jars and labeled as set
out at Paragraph 3 of the stipulation.

The government seeks to have these food substances
condemned pursuant to 21 U.S. C. § 334 which provides in

part:

(a)(1) Any article of food, drug, or cosmetic that is
adulterated or misbranded when introduced into or
while in interstate commerce or while held for sale
(whether or not the first sale) after shipment in inter-
state commerce . . . shall be liable to be proceeded
against while in interstate commerce, or at any time
thereafter, on libel of information and condemned in
any district court of the United States ....

The parties have by their stipulation agreed that this court
has jurisdiction over the instant action, that the food sub-
stances at issue are ‘‘articles of food” within the purview
of 21 U.S.C. § 334, and in effect, that the food substances
have been shipped in interstate commerce in their present
condition. The questions presented for determination on
summary judgment are whether the food substances are
adulterated or misbranded within the meaning of the Act.

The government contends that the food items are adul-
terated within the meaning of 21 U.S.C. § 342 (a) (2) (e)
because they contain sodium nitrate and sodium nitrite;
that the food items are adulterated within the meaning of
21 U.S. C. $ 342(b) (2) because certain plant proteins have
been substituted in part for the principal ingredient—hison
meat; and that the food items are misbranded within the
meaning of 21 U.S.C. § 343 (i)(1). The government must

App. 3

prevail on at least one of these allegations ta permit the
condemnation.

The government contends that the food substance at
issue is adulterated within the meaning of 21 U.S.C.
§ 342 (a)(2)(C) which provides in relevant part:

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 section 348 of this title....

‘*Food additive’’ as used in 21 U.S. C. § 342 is defined by
21 U.S.C. § 321 (s) as follows:

The term ‘‘food additive’’ means any substance the
intended use of which results or may reasonably he
expected to result, directly or indirectly, in its be-
coming a component or otherwise affecting the char-
acteristics of any food ... if such substance is not
generally recognized among experts qualified by sci-
entific training and experience to evaluate its safety,
as having been adequately shown through scientific
procedures (or in the case of a substance used in food
prior to January 1, 1958, through either scientific pro-
cedures or experience based on common use in food)
to be safe under the conditions of its intended use;
except that such term does not include—

* * *

(4) any substance used in accordance with a
sanction or approval granted prior to September
6, 1958, pursuant to this chapter, the Poultry
Products Inspection Act (21 U.S.C. $451 and
the following) or the Meat Inspection Act of
March 4, 1907, as amended and extended;....

Title 21, United States Code, Section 348, provides in rele-
vant part as follows:

(a) <A food additive shall, with respect to any par-
ticular use or intended use of such additives, be deemed

App. 4

to be unsafe for the purposes of the application of
clause (2)(C) of section 342 (a) of this title, 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 in-
tended use are in conformity with, a regulation is-
sued under this section prescribing the conditions
under which such additive may be safely used.

In determining whether the food substance at issue is
adulterated within the meaning of 21 U.S. C. § 342 (a) (2)-
(C), the court must first determine whether the food sub-
stance contained a ‘‘food additive” within the meaning of
21 U.S.C. §321(s). The definition of ‘‘food additive”
consists of two elements: (a) the substanee must become a
component or otherwise affect the characteristics of the
food and (b) the substance inust lack general recognition
among the experts as being safe under the conditions of its
intended use. The parties have stipulated that the food
substance does contain as component parts the items so-
dium nitrate and sodium nitrite. The affidavits subinitted,
by the government adequately support the conclusion that
the use of sodium nitrate and sodium nitrite in conjunction |
with processing bison meat is not generally recognized
among experts as being safe. While the claimant points
to other uses of sodium nitrate and sodium nitrite which
have been recognized as being safe, these examples are not
comparable to the use in this case and so do not refute the
government’s showing or raise a {actual dispute as to
whether the use of these products in bison meat is generally
recognized as safe. Accordingly, the court finds that both
elements of the definition of food additives have been inet.

App. 5

The claimant contends that these substances are ap-
proved for use under the Federal Meat Inspection Act, thus
exempting them from the definition of food additives con-
tained in 21 U.S.C. § 321 (s) and precluding a determina-
tion that the product is adulterated within the meaning of
21 U.S.C. §342 (a)(2)(C). The government responds
that this exception is inapplicable since the Meat Inspec-
tion Act applies only to meat food products which are de-
fined by 21 U.S.C. $601 (i), as:

any product capable of use as human food which is
made wholly or in part from any meat or other portion
of the carcass of any cattle, sheep, swine, or goats ....
This term as applied to food products of equines shall
have a meaning comparable to that provided in this
paragraph with respect to cattle, sheep, swine, and
goats.
Contrary to claimant’s assertion that only added substance
and not the meat to which it is added must be subject to the
Meat Inspection Act, the exemption contained in 21 U.S.C.
§ 321 (s) provides that the use must be ‘‘in accordance with
a sanction or approval granted pursuant to the Meat In-
spection Act.’’ The approval relied on by claimant is found
at 9 C. F. R. § 318.7 (¢) (10), which provides in part:
... the following substances may be added to products:

common salt, approved sugars ... sodium nitrate,
sodium nitrite, potassium nitrate, potassium nitrite...

‘‘Products’’ as used in this regulation are defined at 9
C. F. R. § 301.2 (ww) as

Any carcass, meat, meat byproduct, or meat food pro-
duct, capable of use as human food.

The terms ‘‘careass,’’ ‘‘meat,’’ ‘‘meat byproduct,’’ and
‘‘meat food product’’ all are defined at 9 C.F. R. § 301-

App. 6

(a)(ss) through (vv) in terms of cattle, sheep, swine, goats
and equines only. Thus, the issue is whether bison meat is
within the purview of the Meat Inspection Act when the
term is not specifically included. Only if it is will the use
of sodium nitrate and sodium nitrite here be “in accord-
ance with a sanction or approval granted pursuant to the
Meat Inspection Act.”

The parties have referred the court to no reported
cases regarding the applicability of the Meat Inspection
Act to buffalo meat. An early Missouri case, State v.
Crenshaw, 22 Mo. 457 (1856), does stand for the proposi-
tion that buffalo, although domesticated, are not cattle
within the meaning of a statute making it a crime to ‘‘wil-
fully and maliciously kill, wound or maim any cattle of an-
other.’’ As the policies underlying the Missouri criminal
statutes and the Meat Inspection Act are quite different,

we do not consider this case to be controlling. We there- |

fore, turn to the purpose and the language of the Federal
Meat Inspection Act to resolve the issue.

The Meat Inspection Act is, by its very terms, designed
to protect the health and welfare of consumers:

by assuring that meat and meat food products dis-
tributed to them are wholesome, not adulterated, and
properly marked, labeled, and packaged.

21 U.S.C. § 602.

As such the Meat Inspection Act is not intended to der-
rogate from any authority conferred by the Federal Food,
Drug, and Cosmetic Act. See 21 U.S.C. § 679. Rather,
the Meat Inspection Act creates a seperate area-of con-
cern—(meat and meat byproducts for human consumption)
—over which the Department of Agriculture is given addi-

App. 7

tional powers in the interest of protecting the public health
and welfare.

The Meat Inspection Act specifically delineates the
food products subject to its provisions, listing only foods -
derived from cattle, sheep, swine, goats and equines. Other
food products are regulated under the Food, Drug and Cos-
metic Act. In view of the safeguards of testing and regula-
tion of ingredients set forth in the comprehensive regula-
tions promulgated pursuant to the Food, Drug and Cos-
metic Act, the court finds that food products derived from
bison meat will be adequately regulated for the protection
of the public health and welfare under either the Food,
Drug and Cosmetic Act or the Meat Inspection Act. In
the absence of a congressional determination to include
bison meat within the more limited coverage of the Meat
Inspection Act, this court is unwilling to judicially extend
the provisions of the Meat Inspection Act to do so. Ac-
cordingly, the court finds that the government correctly
seeks to apply the provisions of the Food, Drug and Cos-
metic Act to the food products at issue in this case. There-
fore, the exception to the definition of food additives con-
tained in 21 U.S.C. $321 (s) for substances used in ac-
cordance with a sanction or approval granted pursuant to
the Meat Inspection Act is not applicable.

Having determined that sodium nitrate and sodium
nitrite are food additives within the meaning of 21 U.S. C.
§ 342 (a)(2)(C), the court now turns to the question of
whether or not these additives are ‘‘unsafe within the
meaning of Section 348 of this Title.” Under the pro-
visions of Section 348, a use is deemed to be unsafe for
purposes of the Act unless an exemption is granted by the
Secretary of Health, Education and Welfare upon proper

App. 8

application or unless the use is in accordance with a regu-
lation prescribed by the Secretary. The language of the
statute establishes a presumption that the food additives
are unsafe unless one of the exceptions is established. The
court has carefully examined the regulations promulgated
by the Secretary but has been unable to identify any regula-
tions which are applicable to the instant use of the food ad-
ditives sodium nitrate and sodium nitrite. The claimant has
failed to demonstrate either an exemption or investigative
use or a regulation permitting such use. Accordingly, the
court finds that the claimant’s use of the food additives
sodium nitrate and sodium nitrite are not approved by the
Secretary and, therefore, are unsafe within the meaning
of Section 348 of Title 21, United States Code.

Having determined that the food product at issue is a
food which contains a food additive which is unsafe within
the meaning of Section 348, the court now finds that this
food product shall be deemed to be adulterated within the
meaning of 21 U.S.C. § 342 (a)(2)(C) and subject to sei-
zure pursuant to 21 U.S.C. § 334. As a sufficient basis
exists pursuant to 21 U.S.C. § 842 (a)(2)(C) for the con-
demnation of the food produets seized by the United States
Marshal, this court does not address the alternative allega-
tions of adulteration and misbranding which have been
argued by the government.

A separate decree will be entered this day denying
claimant’s motion for summary judgment, granting sum-
mary judgment for the plaintiff, and decreeing the food
products at issue to be adulterated within the meaning of
the Food, Drug and Cosmetic Act and subject to condemna-
tion. Within twenty days following entry of this order, the
parties shall submit to the court for its approval a pro-

App. 9

posed method for disposition of the condemned goods.
The costs of this action shall be taxed against the claimant
in accordance with 21 U.S.C. § 334 (e).

By the Court:

/s/ Albert G. Schatz
Judge, United States District Court

ORDER
(Filed July 12, 1978)
In accordance with the memorandum opinion entered

this date,

IT IS WHEREBY ORDERED that claimant’s motion
for summary judgment (Filing No. 6) is denied.

IT IS FURTHER ORDERED that plaintiff’s motion
for summary judgment (Filing No. 10) is sustained.

IT IS DECREED that the food products at issue are
adulterated and are subject to condemnation. The parties
shall submit to the court within twenty (20) days a pro-
posed method for disposition of the condemned goods.

IT IS FURTHER ORDERED that costs of this action
are to be taxed against the claimant.
By the Court:

/s/ Albert G. Schatz
Judge, United States District Court

=

App. 10

APPENDIX B

UNITED STATES COURT OF APPEALS
FOR THE EIGHTH CIRCUIT

No. 78-1643

UNITED STATES OF AMERICA,

Appellee,
vs.

ARTICLES OF FOOD, ETC., ROBERT NIELSEN
d/b/a GRUMPY’S BUFFALO JERKY CoO.,

Appellant.

Appeal from the United States District Court for the
District of Nebraska

Submitted: January 12, 1979
Filed: January 16, 1979

Before ROSS and MeMillian, Cireuit Judges, and VAN
SICKLE, District Judge.*

PER CURIAM.

In this appeal Robert Nielsen d/b/a Grumpy’s Buifalo
Jerky Co. seeks review and reversal of an order of the
district court which concluded that the food product buffalo
jerky was adulterated within the meaning of 21 U.S.C.
§ 342 and subject to seizure pursuant to 21 U.S.C. § 334

*The Honorable BRUCE M. VAN SICKLE, United States District
Judge for the District of North Dakota, sitting by designation.

App. 11

due to the fact that the product contained an unsafe ‘food
additive’? within the meaning of 21 U.S.C. $348.

We have carefully considered the arguments which ap-
pellant has made, including the argument that a substance
cannot be declared an unsafe ‘‘food additive’’ in one con-
text, but acceptable in another use, and the argument that
the Meat Inspection Act, which approves certain uses of
sodium nitrates and sodium nitrites, shouid be construed
to include ‘‘buffalo’’? meat within its terms, although buf-
falo is not expressly listed.

After reading the appellant’s citations of authority,
and reviewing the affidavits submitted, we conclude that
the district court did not err in its well-reasoned opinion
and affirm on the basis of that opinion.

The judgment is affirmed.

A true copy.

Attest:

Clerk, U.S. Court of Appeals,
Kighth Circuit.

[Not to be published. |

App. 12

APPENDIX C

FOOD, DRUG AND COSMETIC ACT
21 U.S.C. See. 301, et. seq. .
21 U.S.C. See. 321 (s)

The term ‘‘food additive’? means any substance the
intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becom-
ing a component or otherwise affecting the charac-
teristics of any food ... if such substance is not gen-
erally recognized among experts qualified by scientific
training and experience to evaluate its safety, as hav-
ing been adequately shown through scientifie proce-
dures (or in the case of a substance used in food prior
to January 1, 1958, through either scientific procedures
or experience based on common use in food) to be safe
under the conditions of its intended use; except that
such term does not include—

* ” *

(4) any substance used in accordance with a sanction
or approval granted prior to September 6, 1958, pur-
suant to this chapter, the Poultry Products Inspection
Act (21 U.S.C. See. 451 and the following) or the
Meat Inspection Act of March 4, 1907, as amended and
extended; ...

21 U.S.C. See. 342 (a)(2)(C)

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 section 348 of this title...

21 U.S.C. See. 348

(a) <A food additive shall, with respect to any par-
ticular use or intended use of such additives, be deemed
to be unsafe for the purposes of the application of
clause (2)(C) of section 342 (a) of this title, unless—

App. 13

(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 in-
tended use are in conformity with, a regulation
issued under this section preseribing the condi-
tions under which such additive may be safely
used.

MEAT INSPECTION ACT
21 U.S.C. See. 601 et. seq.
21 U.S.C. See. 601 (J)

The term ‘‘meat food product’? means any product
capable of use as human food which is made wholly
or in part from any meat or other portion of the car-
cass of any cattle, sheep, swine, or goats ****. This
term as applied to food products of equines shall have
a meaning comparable to that provided in this para-
graph with respect to cattle, sheep, swine, and goats.

21 U.S.C. See. 601 (m)(2)(C)

(m) The term “adulterated’’ shall apply to any car-
cass, part thereof, meat or meat food product under
one or more of the following circumstances: . . .

(2) (C) if it bears or contains any food additive which
is unsafe within the meaning of section 409 of the Fed-
eral Food, Drug, and Cosmetic Act...

9 C.F. R. See. 301.2

(rr) Livestock. Cattle, sheep, swine, goat, horse,
mule or other equine.

(ss) Carcass. All parts, including viscera, of any
slaughtered livestock.

(ww) Product. Any carcass, meat, meat byproduct,
or meat food product, capable of use as human food..

9 C.F. R. See. 318.7 (¢) (10)

App. 14

... the following substances may be added to products:
common salt, approved sugars ... sodium nitrate,
sodium nitrite, potassium nitrate, potassium nitrite...

21 C. F. R. See. 172.170

The food additive sodium nitrate may be safely used
in or on specified foods in accordance with the follow-
ing prescribed conditions:

(a) It is used or intended for use as follows:...
21 C.F. R. See. 172.175

The food additive sodium nitrite may be safely used
in or on specified foods in accordance with the follow-
ing prescribed conditions:

(a) It is used or intended for use as follows:...

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385006_0204%3A1. Public record. Not legal advice.