Petition — Articles of Food v. United States

In The

Supreme Court of the United States

October Term, 1978

8)

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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.

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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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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:...