Petition — National Pork Producers Council v. Block

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1, i supreme Lourt, U. 9.

FILED

80-74 NOV 10 1980

Mo. 742

—— ye insscsscompicos JR., CLERK

Iu the

Supreme Court of the United States

Octoser TERM, 1980

NATIONAL PORK PRODUCERS COUNCIL, CHARLES

GRASSLEY, THOMAS HAGEDORN, and STEVEN SYMMS,

Petitioners,

vs.

BOB BERGLAND, Secretary of Agriculture, CAROL TUCKER

FOREMAN, and DONALD H. HOUSTON,

Respondents.

PETITION FOR WRIT OF CERTIORARI TO THE

COURT OF APPEALS FOR THE EIGHTH CIRCUIT

DONALD P. COLLETON

Counsel of Record

JAMES L. FOX

ABRAMSON & FOX

One East Wacker Drive

Chicago, Illinois 60601

(312) 644-8500

Attorneys for Petitioners

UNITED STATES LAW PRINTING CO., CHICAGO, ILLINOIS 60618 (312) 525-6581

QUESTIONS PRESENTED FOR REVIEW

Whether the court of appeals in its review of United

States Department of Agriculture rulemaking has itself, in

disregard of Overton Park*, arbitrarily exposed the

American consumer to the deadly hazards of botulism.

Whether USDA exceeded its authority in promoting

sales of unpreserved foods through a rule which needless-

ly jeopardizes public health.

Whether the decision below permitting USDA to omit

assessment under the National Environmental Policy Act

of a department rule’s public health impact conflicts with

the construction placed on NEPA by other circuits and if

so whether this Court should resolve the conflict.

PARTIES

Petitioners

NationaL Pork Propucers CounciL

CuHarLes Grasstey M.C.

Tuomas Haceporn M.C.

Steven Syms M.C.

Respondents

Bos Brerciand, Secretary of Agriculture

Caro, Tuckrr Foreman, Assistant Secretary of Agricul-

ture

Donatp H. Houston, Acting Administrator of the Food

Safety & Quality Service within the Department of

Agriculture

* Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402

(1971).

iil

TABLE OF CONTENTS

PAGE

a cia cpnninaysancoctconcectnncnesvere v

Constitutional Provisions and Statutes -......00020020....... vii

ness sncesesdacousonsnsonicosiesenebtvsceanse 2

EE NDE SOL OO 2

Statutory Provisions Involved ~.......22...2....:.:c:ccceeceeeeeees 2

Statement of the Case —..0.0.0.000.0.000...0.. STL A ee ee 2

The Proceedings and Jurisdiction of the Court

a cicaecipecedteionccemuevchdoarsenaeomenecensvees 2

RESTS SO a ote CE 3

| ee 3

Se nos sceussbhsseneneseactee 3

C. The Rulemaker’s Explanation ...................... 7

D. Final Impact Statement ..............................0 8

EK. The District Court’s Review ....................... 9

F. The Circuit Court’s Review .......................--- 10

Reasons for Granting the Writ 2.002000... cece 11

I. The Department’s Disregard of Relevant

Factors Violates the Requirements of Over-

ton Park and Seriously Jeopardizes Con-

sumer Health and Safety -.....0020200200..... 11

a) Labeling efficacy overlooked ...................... 12

b) Botulism risk overlooked ..........0................. 18

PREVIOUS PAGE WAS BLANK |

PAGE

II. The Department Exceeded its Authority by

Promulgating the Rule for an Unlawful

RR EEE ENC oe ea OE 2 is 22

III. This Court Should Resolve the Conflict Be-

tween the Circuits Regarding the Require-

ments of ihe National Environmental Policy

BE siieenientprerhcaiigtadectighi bia a iat eke idathbandibals 24

PLR ae AL SCI SLD NR RT 26

Appendix

Opinion of Court of Appeals (8th Cir. September

SINUS Lalinscsdinnntdal schaticsadraalesteglbhahacsnsigakss clade App. 1

Final Ruling and Order (S.D. Ia. February 12

OD pains aconidnhcaccindarndadabedebicated dtspacsnsdh App. 21

NIE. ities dibdencdeetiniacoedcied. icledbbecitaen App. 48

pe ADSI re Ponte) RR Li App. 48

ee eR

OP Chia ee Scie ae FPA WRU App. 50

OP Shae SOROe ksi App. 51

Notice of Proposed Ruiemaking, 43 Fed. Reg.

18193-18195 (April 28, 1978) 2.0.o.u........ccccscececoeee App. 52

Selected Comment

RENT RN OR Ah EP SN eR App. 60

RII: III. seciehseensoenihidimibiin, slbidlicsephaidias tec anlar el tree App. 65

fe TS IETS TER, AER! App. 70

Final Impact Statement, June 14, 1979 .................... App. 72

Final Rule and Preamble, 44 Fed. Reg. 48959-

48961 (August 21, 1979), 9 C.F.R. §§317.17(b)

ec. ec cc Oe I Oe Ma App. 83

Transcript Excerpts (November 9, 1979) ............ App. 94

TABLE OF CASES

PAGE

Angel v. Butz, 487 F2d 260 (10th Cir. 1973), cert. de-

I Er is PE CED iasektcch dicing -ncgeeecdteeestiicnlenes 15

Asarco, Ine. v. E.P.A., 616 F2d 1153 (9th Cir. 1980)... 11

Burlington Truck Lines v. U. S., 371 U.S. 156 (1956)..15, 16

Camp v. Pitts, 411 U.S. 138 (1973) .................cccescecscswese 13

Citizens to Preserve Overton Park v. Volpe, 401 U.S.

ag 5 rae nape ne eee 11, 12, 13, 16, 18, 25, 26

Environmental Defense Fund v. E.P.A, 465 F2d 528

See ONIN UPI igiictroac% scscetdatireneniaeaennntepoas ipitamelaninnenlinbis 17

Environmental Defense Fund, Inc. v. Ruckelhaus, 439

ee SNe TE) 5 cekincnsdeataceniincnnidaieseobalaevies 15

Federal Security Administrator v. Quaker Oats Co.,

ST, SIR scenic 18

Federation of Homemakers v. Butz, 466 F2d 462 (D.

Se TE UE UE sukahiecs sie ecenctamhalantstdlaminiliptasntiineedinbamaiaabinnniianipnen 18

First National Bank of Fayetteville v. Smith, 508 F2d

1371 (8th Cir. 1974), cert. denied, 421 U.S. 930 (1975) 11

Pw, Deen BAF UE. BO CORT OD, secctecectessecenncicrsenscsccns 25

Greene County Planning Board v. FPC, 455 F2d 412

(2nd Cir.), cert. denied, 409 U.S. 849 (1972) ............ 25

Hiatt Grain and Feed, Inc. v. Bergland, 602 F2d 929

(10th Cir. 1979), cert. denied, ...... US. ..... (1980) ... @

Houston v. St. Louis Independent Packing Co., 249

Ek, HAE. GNI, “scccsdinchdsveahctdeebeuiiasnaveneirs tasipiiohecsiadninbenstginnnns 18

Karlen v. Harris, 590 F2d 39 (2nd Cir. 1978) .............. 25

National Nutritional Foods Ass’n. v. Weinberger, 512

F2d 688 (2nd Cir.), cert. denied, 423 U.S. 827

STR scene iiaicttedesninheiiipigiionaiecioinniteiatiieigientniesectnsentiiaiata 15, 16

PAGE

National Organization for Reform of Marijuana Laws

v. U. S., 452 F. Supp. 1226 (D.D.C. 1978)... 25

Nucleus of Chgo. Homeowner Assn. v. Lynn, 524 F2d

225 (7th Cir. 1975), cert. deneid, 426 U.S. 939 ( 1976) 24

Phelps Dodge Corp. v. NLRB, 313 U.S. 177 (1941) ... 21

Poleover v. Sec’y of Treasury, 477 F2d 1223 (D.C.

Cir.) cert. denied, 414 U.S. 1001 (1973) 00. 11

Rodway v. USDA, 514 F2d 809 (D.C. Cir. 1975) ........ 22

Sabin v. Butz, 515 F2d 1061 (10th Cir. ae 13

Scientists Institute for Public Information v. Atomic

Energy Commission, 481 F2d 1079 (D.C. Cir. 1973) 24

SEC v. Chenery, 318 U.S. 80 (1943) ——a_ ~ {

SEC v. Chenery, 332 U.S. 194 (1947) 000. 15, 22

Sec’y of Agriculture v. U. S., 347 U. S. 645 (1954) ... 15

Steubing v. Brinegar, 511 F2d 489 (2nd Cir. 1975) ... 25

S. W. Neighborhood Assembly v. Kekard, 445 F. Supp.

ee NRE TN Soe REE LS 25

Tabor v. Joint Board, 566 F2d 705 (D.C. Cir. 1977 )..22, 25

Trinity Episcopal School Corp. v. Romney, 523 F2d

CS (Ue Gi CIGD anit ee 24

U. S. v. Chgo. Milwaukee, St. Paul & Pac. Ry., 294

SS: | ern Wee Ft eS 15, 22, 25

U. S. v. Neva Scotia Food Products Corp., 568 F2d

240 (2nd Cir. 1977) .............. linsentilpinkcesiaiegiiitbinahieeliditaai’ 13, 14

Vermont Yankee Nuclear Power Corp. v. NRDC, 435

Ci SOD GD di hei ee 11, 13, 26

Wagner Electric Corp. v. Volpe, 466 F2d 1013 (3rd

Ce: SE ‘ncaa seciensiditiiitetadericleitihatiniagi 22

Wellford v. Ruckelhaus, 439 F2d 598 (D.C. Cir. 1971) 20

Vil

Constitutional Provisions and Statutes

PAGE

Be III. “ohisteceth sho hianntedins cinbeonqaniaphisinadtiiuecnsonadveen illtinaisiniessions 22

Oh I III wikis sccpens deitcrsaprisiionsvvbecinnaspenecahnsnedthivenseigies 3

Ts ENE TET © scestienenonstblegoentinillighensdikceceisinhonéguinnen cote 26

Bt GI wired cen tocercinstnstios hicinieeibinbatbenabiconnteaienaas 3

EEE MIE BD “oases ccediscnqusdvthcningiaitlinntsdncunecanainesotoeininaniie 2

SE AIEEE | cdbcsscisshiietscsdvaescicnens conse Leeenennateinbvtiotoastesephiboekis 3

28 U.S.C. §§1331, 1332, 1837 and 2201-2202 ................... 3

Br NII ic ras bsosavadiniedianeaeaobarbectusisaienaectannnisedeiionnied 24

9 C.F.R. §§317.17(b) and (c) and 319.2 ......................... 2

40 C.F.R. 1501.4(¢c) and (e) and 1508.19 ....................... 24

Oe EIN aria icecachiencesipeseexatinssonannetenioinaionts 25

39 Fed. Reg. 18680 (May 29, 1974) .W.2... eee 20

43 Fed. Reg. 21987 (May 22, 1978) .20.0..........sccc-seececeneee 20

Iu the

Supreme Court of the United States

OctrosEerR TERM, 1980

No.

NATIONAL PORK PRODUCERS COUNCIL, CHARLES

GRASSLEY, THOMAS HAGEDORN, and STEVEN SYMMS,

Petitioners,

vs.

BOB BERGLAND, Secretary of Agriculture, CAROL TUCKER

FOREMAN, and DONALD H. HOUSTON,

Respondents.

PETITION FOR WRIT OF CERTIORARI TO THE

COURT OF APPEALS FOR THE EIGHTH CIRCUIT

TO: The Honorable Chief Justice of the United States

and the Associates Justices of the Supreme Court of

the United States:

Petitioners respectfully pray that a Writ of Certiorari

issue to review the opinion of the United States Court of

Appeals entered September 23, 1980, reversing the perma-

nent injunction of the district court in Des Moines.

OPINIONS BELOW

The district court’s opinion is published at 484 F. Supp.

040 (S.D. Ia. 1980). The opinion of the court of appeals

has not been officially published. Both opinions appear in

the Appendix.

JURISDICTION

The decision of the court of appeals was entered on

September 23, 1980 within ninety days of which this peti-

tion has been filed. Jurisdiction in this Court is invoked

under 28 U.S.C. §1254(1).

STATUTORY PROVISIONS INVOLVED

This petition involves:

9 C.F.R. §§317.17(». and (c) and 319.2

5 U.S.C. $553

5 U.S.C. §706(2) (A)

42 U.S.C. $4332

40 C.F.R. 1501.4(c) and (e) and 1508.13

These provisions appear in the Appendix.

(Emphasis added throughout unless otherwise indicated )

STATEMENT OF THE CASE

Proceedings and Jurisdiction of the Court Below On

September 20, 1979 the Natrona, Pork Propucers Councu.

and three United States Congressmen brought suit in the

Southern District of Iowa to enjoin, as arbitrary and

capricious, a United States Department of Agriculture

(Department) labeling regulation, 44 Fed. Reg. 48959-61

(August 21, 1979), 9 C.F.R. §317.17(b) and (c) and

$319.2 (the Rule), App. 91-93, which permits nitrite-free

foods to be sold under the guise and name of traditional

nitrite preserved foods. Jurisdiction was invoked under

21 U.S.C. $674, 5 U.S.C. $§$701-706 and 28 U.S.C. §1331,

1332, 1337 and 2201-2202. On February 12, 1980 the dis-

trict court permanently enjoined enforcement or applica-

tion of the rule. App. 21-47. The government appealed

basing jurisdiction for appzal on 28 U.S.C. §1291. On

September 23, 1980, a panel of the Eighth Circuit re-

versed, App. 1-20, but upon petitioners’ motion has stayed

issuance of its mandate pending consideration of the case

by this Court.

THE FACTS

A. Botulism and Nitrite

Clostridium botulinum, a bacterium considered present

in all raw foods, produces a deadly toxin known as botulin

in a short period of time at elevated temperatures in the

absence of molecular oxygen. When added to food as a

preservative, nitrite salts have proven highly effective in

inhibiting the production of botulin in meat products. As

a result popular nitrite-cured products such as frank-

furters, cold cuts and bacon can be and are sometimes,

perhaps often, handled safely in unrefrigerated ways which

without nitrite could promote the formation of botulin.

B. The Rulemaking

On April 28, 1978 the Department’s Food Safety &

Quality Service proposed the challenged Rule, App. 52-59,

in response, according to the Court below, App. 13-16, to

suggestious by some that ‘‘nitrite-free products were dif-

ficult to locate or not available.’’ App. 15. Under the

proposal, nitriteless meat products could have the same

flavor, consistency and name of meats preserved with

nitrites provided labeling disclosed the absence of nitrite

and called for refrigeration below 40° F.

The proposal drew 365 comments. Among others, these

concerns were expressed:

(1) The proposed cautionary labels will not be read

at all by many. A variety of reasons for this was

suggested. Some habitually do not read labels. Others,

because of illiteracy, old or young age or language

barriers, cannot read them. The presence of familiar

color, form, and texture, coupled with the common

name, will implicitly persuade still others that the

product is the familiar one and hence there is no rea-

son to search the label for new, special handling in-

structions.

(2) Some who read the label wil] not understand the

disclosures.

(3) Some who read and understand the label dis-

closures, will, not unreasonably, be skeptical because

everything else about the apparently familiar product

will seem to contradict the warning.

(4) Consumers will be greatly confused.

(5) Because many consumers have long learned prac-

tices of handling cured products in ways that would

be hazardous without nitrite, the proposed label dis-

closure will not suffice to protect against botulism. As

a result, the Rule will injure consumers and the entire

meat industry.

See, e.g., Comments 97, 130, 169, 174, 175, 182, 186, 190,

197, 199, 206, 252, 253, 257, 258 (App. 60), 260 (App.

65), 273, 280 (App. 70), 290, 291, 298, 324, 329 and 352.

The same concerns were later reiterated at a meeting of

the Department’s Meat and Poultry Advisory Committee,

attended by respondents Houston and Foreman.

To illustrate, a public interest group wrote:

‘‘The consumer who is accustomed to leaving cold cuts

or frankfurthers exposed and is uncautious with left-

overs is unlikely to change his or her habits when pre-

sented with what appears to be the same product, with

the addition of a warning label.

The required duplication of the original product in

color, form and texture, coupled with the use of the

same product name, will promote acceptance; the con-

sumer’s familiarity with the product, however, will

reduce the likelihood that the label will be read for

new requirements of product use.

‘¢ Assuming the label is read, there is the added prob-

lem of consumer skepticism or indifference. Products

which have been widely used and accepted have sud-

denly been proclaimed ‘unsafe’ and a rash of new

warning labels have appeared. The result is that the

labeling device is losing credibility, as is apparent

with cigarette and saccharin warnings. Where there

is no apparent product change, the consumer may ig-

nore any warnings or directions on new use or new

dangers of products, assuming that they are merely

new warnings attached to an old product which they

know how to use.

‘‘The proposed rule would allow both the product

cured with nitrite and the product preserved without

or with low levels of this substance to be available to

cousumers, and to be marketed under the self-same

name. The potential for misuse and confusion seems

obvious where consumers are confronted with two

products which are virtually indistinguishable but de.

mand different use habits.

‘‘The marketing of both meat products under the

commonly-used name may increase the risk of botu-

lism and other diseases. A higher incidence of botu-

lism exists in countries which do not cure meats with

nitrites .. . The confusion resulting from two prod-

ucts with different use requirements but the same

product name might even compound the botulism

problem, with consumers being less cautious than

where only a nitrite-free product is available. In ad-

dition, the packaging will become separated from the

food product. As a result, leftovers and/or products

stored out of their original packaging will give no

warning of the procedures required to avoid risk. The

effect of the proposed rule may therefore ultimately

be a reduction in confidence and consumer use of both

the nitrite-free produce and the nitrite-cured prod-

uct.’’ Comment 260; App. 65-69

Notably, while commentators familiar with nitrites or

desirous of avoiding foods containing them, suggested that

they would read the proposed labeling instructions, few

contended directly that these instructions would in fact

be read by all or most consumers. The rulemaking reeord

contains no professional or expert studies, testimony, com-

ment or analysis of any kind establishing the fact, likeli-

hood or even possibility that the warning labels would be

generally read, understood or believed by ordinary con-

sumers, apart from those interested in the current nitrite

controversy.

Notwithstanding the concerns expressed, the Rule for

labeling unpreserved meats, as proposed, was adopted on

August 21, 1979 with the added requirements that nitrite-

free meats be similar to preserved meats in size and qgen-

eral appearance and, as originally proposed, in flavor and

consistency and that the term ‘‘uncured”’ precede the tra-

ditional name. App. 91-93. That term. according to the

rulemaker, is ‘‘commonly understood’’ to mean that the

product does not contain nitrite. App. 85.

Neither the preamble to the Rule nor the Rule itself

addressed the concerns, listed above, of commentors and

the Committee other than to note that questions had been

‘

raised about the adequacy of the proposed warning labels

and to observe, without explanation, that the Administra-

tor

‘ig aware that the products requiring such special

handling such as pork sausage, bratwurst and bock-

wurst have presented no apparent health hazards even

though prepared without nitrates or nitrites and mar-

keted unfrozen. He concludes that consumers have

demonstrated a knowledge of the handling practices

necessary for any of such products prepared without

nitrates or nitrites and that the prescribed labeling

for such products, i.e., ‘‘Not Preserved—Keep Re-

frigerated Below 40°F At All Times’’, will adequately

inform the consumer of how to maintain such products

in a wholesome condition until consumed.’’ App. 86-87.

The Rulemaker’s Explanation

In the course of the district court’s review, the govern-

ment explained the challenged rulemaking through Irwin

Fried, the Department employee who supervised the ad-

ministrative proceeding. His explanation ran as follows:

1. It is true ‘‘that nitrites have been found to prevent

the growth of clostridium botulinum, a natural conta-

minant of improperly preserved meat products, and

which produces an extremely potent poison usually

fatal to man; that there are no substances that could

be utilized under sufficiently broad scale to prevent

botulism in commercially processed meats’’ end that

‘‘without nitrites’’ ‘‘|c|ommon usage of such products

as hot dogs and ham would not be possible without

severe health hazards.’’ Tr. 146, App. 95-96.

2. He would agree that ‘‘not too many people read

... handling mstructions’’ but instead rely on ‘‘previ-

ous experience.’’ Tr. 195; App. 97-98.

3. His basis for believing consumers will read the

label prescribed by the Rule [the sole means proposed

by the Rule to distinguish an apparently nitrite-pre-

served from a nitrite-free product] is ‘‘everything

that we have received ... from people who want to

have nitrite-free products.’’ Tr. 197, App. 98.

4. No consideration is given in the Rule as to how

consumers are to be protected from the hazards of

nitrite-free products which look like traditional ni-

trite-preserved products when

a) the prescribed label is removed.

b) the nitrite-free products are sold in bulk as in

delicatessen sales when bologna is hand-sliced

and wrapped.

c) the nitrite-free products are ‘‘displayed in the

old-fashioned cases with the butcher behind.

and there are no labels on the product.”’

d) the consumers are non-English speaking.

e) the consumers are functional illiterates, Tr. 142-

3, App. 94-95.

0. Not ‘‘everybody’’ will understand what the term

‘“‘uncured’’ (as required by the Rule to alert consumers

to the nitrite-free character of what appears to be a

traditional nitrite-preserved product) mrans. Tr. 192,

App. 96.

6. He does not know whether the meaning of ‘‘un-

cured’’ would be understood by functional illiterates,

non-English speaking consumers or children, Tr. 192-

3; App. 96-98.

Final Impact Statement

A Final Impact Statement (FIS) for the Rule, App. 72-

82 disclosed in a note to the final Rule, App. 93 showed:

(1) some 34 establishments market nitrate and/or

nitrite-free processed meat products under 168

different product labels.

(2) the Rule was expected to advantage nitrite-free

product manufacturers by facilitating develop-

ment of their markets.

(3) the Rule was not expected to result in any increase

in the incidence of types A and B botulism because

‘*these types do not generally grow at tempera-

tures below 40°F.’’

The FIS also noted concerns expressed in the Comments

about consumer confusion between nitrite-free and nitrite-

preserved products and about

‘‘the possibility that abuses could occur because of

. careless food handlers ... and food taken on

picnics, to work, and to school.’’

The FIS did not undertake to answer these concerns.

E. The District Court’s Review

Confining its review to the administrative record and

the explanatory testimony offered by the government, the

district court set aside the Rule on four grounds:

(1) a lack of rational basis in the record for the con-

clusion that ordinary consumers, faced with a long-

established product and a new product which differ

only in the information on its label, will distinguish

between the two and a failure by the Department ade-

quately to consider relevant factors regarding con-

sumer conduct in reading labels and caring for nitrite

products and the resulting danger of botulism from

similar handling of nitriteless products. App. 29-32.

(2) lack of Department authority to enact a rule

solely to facilitate markets of uncured producers at

the expense of producers of cured products. App. 36.

(3) lack of Department authority to impose the simi-

larity requirements and subjective flavor standard

contained in the Rule. App. 36-41.

(4) failure to comply with the requirements of the

National Environmental Policy Act in that the De-

partment neither filed nor considered the need to file

an Environmental Impact Statement. App. 44-47.

F. The Circuit Court’s Review

The court of appeals reversed, concluding that:

(1) the Department adequately considered the risk

of botulism and the efficacy of the required labeling

(2) the Department’s purpose in adopting the Rule

was to expand the availability of nitriteless products,

and that this purpose, when accomplished ‘‘in a form

and manner consistent with the public health and wel-

fare’’, was lawful, and that the Rule bears a rational

relationship to this purpose

(3) the similarity and subjective flavor requirements

are lawful

(4) the agency considered the Rule’s potential for

significantly affecting the quality of the human en-

vironment and properly found no such effects.

REASONS FOR GRANTING THE WRIT

Courts should generally leave regulations to the regula-

tors. Vermont Yankee Nuclear Power Corp. v. NRDC, 435

U.S. 519 (1978). When, however, regulators substantially

omit the key issue inquiry and analysis required for ra-

tional rulemaking, Congress has authorized judicial inter-

vention, not to rewrite bad rules but to shield the public

from their arbitrary effects. Citizens to Preserve Overton

Park v. Volpe, 401 U.S. 402 (1971). When the impact of

deficient rulemaking is life-threatening, this Court is the

public’s last but most necessary protection. The presently

challenged Rule, by arbitrarily exposing consumers to

botulism food poisoning, is such a rule and, therefore, war-

rants this Court’s scrutiny.’

The Department’s Disregard of Relevant Factors Violates

the Requirements of Overton Park and Seriously

Jeopardizes Consumer Health and Safety

The most compelling reason for granting the writ is the

Rule’s jeopardy to human health resulting from manifest

1 Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971)

establishes the standards for judicial review of agency action under

the arbitrary and capricious standard of the Administrative Pro-

cedure Act, 5 U.S.C. §706(2)(A). In making that review, this

Court accords no special deference to the decisions of the court of

appeals or district court, Cf. Asarco, Inc. v. E.P.A., 616 F.2d 1153,

1161 (9th Cir. 1980) ; Polcover v. Sec’y of Treasury, 477 F.2d 1223,

1226-27 (D.C. Cir.), cert. denied, 414 U.S. 1001 (1973); First

National Bank of Fayetteville v. Smith, 508 F.2d 1371, 1374 (8th

Cir. 1974), cert. denied, 421 U.S. 930 (1975), but itself makes

a fresh determination of whether the statutory requirements have

been met.

agency disregard of factors bearing directly on consumer

safety.

The Rule permits unpreserved meats to be sold in the

marketplace under the names of and in forms visually

(size and color) identical to preserved meats such as hot

dogs, bologna and bacon. Because without nitrites meats

support the production of botulin if subjected to the un-

refrigerated handling (picnics, overnight camping, school

lunching, etc.) associated with the traditional products, the

crucial questions in the rulemaking were (1) whether the

cautionary labeling prescribed by the Rule for unpreserved

meats would be read, understood and believed by ordinary

consumers so as to forestall the unrefrigerated use pres-

ently associated with preserved counterparts and (2) if

not, what increased risk of botulism would result under

the Rule. Petitioners contend that contrary to the require-

ments of Citizens to Preserve Overton Park vy. Volpe,

supra, the Department not only gave insufficient considera-

tion to these questions but knew at the time it promulgated

the Rule that labeling would not suffice to alter handling

practices or remove the danger of botulism. Hence peti-

tioners say the Rule is arbitrary and capricious.

a) Labeling efficacy overlooked

It was no doubt the potential for illness from confusion

of look and name alike products that led the rulemaker to

consider a requirement for distinctive precautionary label-

ing in the final Rule. See, e.g., App. 84-85. The rulemaker

and the court of appeals, however, did net go on to assess

whether that requirement—the sole means of protection

afforded by the Rule—would be efficacious under the cir-

cumstances mentioned in the Comments. Therein lies the

deficiency and health danger of which the present peti-

tioners complain.

More specifically, under the labeling requirement the

plight of illiterates, non-English speaking consumers and

those with infirm vision-—interests clearly present in the

consumer body and noted in the comments—arbitrarily

was not considered either by the rulemaker or by the court

of appeals in its review. Indeed, there is not mere silence

on this point, which without more would be a proper basis

for setting the Rule aside, Sabin v. Butz, 515 F2d 1061,

1069 (10th Cir. 1975); U. S. v. Nova Scotia Food Products

Corp., 568 F2d 240, 251 (2nd Cir. 1977); rather, in ‘‘ex-

plaining’’ its position, Overton, supra, 401 U.S. at 420;

Camp v. Pitts, 411 U.S. 138, 143 (1973). the Department

affirmatively conceded that the final Rule omits considera-

tion not only of illiterates and the non-English speaking

but of consumers in general when the precautionary label

is removed or the product is sold without labels as through

delicatessens. App. 94-95. This failure alone requires re-

versal.”

The Department’s analysis of the efficacy of the required

labeling in protecting literate, English speaking people

when the label remains attached is equally inadequate.

The administrative record® shows, and the court of appeals

and district court found App. 11 and 32, that some com-

mentators said

2 Petitioner's do not ask this Court to substitute its judgment

for that of the Department. Vermont Yankee Nuclear Power Corp.

v. NRDC, supra, says that where the rulemaker fails to indicate

judgment either way or the basis for its judgment on a relevant

factor such as protection of large subgroups in the population, the

rulemaking cannot be sustained.

* The administrative record consists of the April 28, 1978 Notice

of Proposed Rulemaking, App. 52-59, 365 Comments, a transcript

of the July 18, 1979 meeting of the Department’s Meat and Poultry

Advisory Committee at which the proposed rule was discussed, the

August 21, 1979 final rule and explanation. App. 83-93, and the

FIS. App. 72-82.

they acquire knowledge of food products from label

reading and

they are willing to follow handling instructions.

These comments came largely if not exclusively from

either nitrite-free manufacturers or from individual con-

sumers or professional consumer groups with an active

preference for additive-free foods or a professed hostility

toward nitrite. See, e.g., Comments 54, 106, 132, 196 and

246 cited by the government in the court below. Indispu-

tably they would search out label information about ni-

trites and safe handling. The relevant question, however,

concerned not what those people would do with the cau-

tionary label prescribed by the Rule but what ordinary

consumers, who consume millions of pounds of hot dogs,

lunch meats and bacon daily and who have little or no

acquaintance with or interest in the nitrite controversy,’

would do.® The final Rule fails, and petitioners submit,

* If the Department believed the anti-nitrite comments were fairly

representative of the ordinary consumer who consumes and wishes

to continue consuming traditional, preserved meats, Overton Park

required a clear statement to that effect and the reasons justifying

it in the preamble to the Rule so as to facilitate proper judicial

review. The absence here of both precludes this Court from in-

cdulging in or sustaining such a belief and thereby the Rule.

(". S. v. Nova Scotia Food Products Corp., 568 F.2d 240, 251

(3rd Cir. 1977).

"The Department official responsible for the rulemaking says

his basis for believing consumers will read the label prescribed by

the Rule is “everything that we have received . . . from people who

want to have nitrite-free products.” App. 98. No doubt that is

true. But the observation only points up more sharply the Depart-

ment’s irrational conclusion that all other people, patently the over-

whelming majority of consumers, who are not cognizant of or in-

volved in the nitrite controversy will search out special handling

instructions on the labels of what appear to be the same hot dogs

and lunch meats they have been purchasing and subjecting to un-

refrigerated use all their lives.

fatally, to disclose that the Department made any analysis

whatsoever of this factor. National Nutritional Foods

Ass’n v. Weinberger, 512 F2d 688, 701 (2nd Cir.), cert.

denied, 423 U.S. 827 (1975) ; Environmental Defense Fund,

Inc. v. Ruckelhaus, 439 F2d 584 (D. C. Cir. 1971); Angel

v. Butz, 487 F2d 260, 263 (10th Cir. 1973), cert. denied, 417

U.S. 967 (1974).

Even if, contrary to proper procedure, SEC v. Chenery,

332 U.S. 194, 196 (1947); Sec’y of Agriculture v. U.S., 347

U.S. 645, 653-4 (1954); U. S. v. Chgo Milwaukee, St. Paul

& Pac Ry., 294 U.S. 499, 510-511 (1985); Angel v. Butz,

supra, this Court were to attempt its own analysis of label

efficacy, it would find the administrative record barren of

any expert comments, studies, surveys or treatises tending

to establish that ordinary consumers would read the cau-

tionary information contained in the challenged labels.° In

‘Tf the Department wishes to rely on agency “expertise or ex-

perience” to establish that consumers will universally read, under-

stand aad believe its cautionary labels, that reliance must ‘be clearly

disclesed and adequately sustained”, SEC v. Chenery Corp., 318

U.S. 80, 94 (1943) “in the [challenged] order . . . itself”, Burlington

Truck Lines vy. U. S., 371 U.S. 156, 169 (1962), that is “in the

‘Statement of the Bases and Considerations’ filed with the adopted

vegulations.” Angel v. Butz, 487 F.2d 260, 263 (10th Cir. 1973),

cert. denied, 417 U.S. 967 (1974). No such disclosure appears

in the present rulemaking. Indeed, there is complete silence with

regard to the critical aspects about label reading, e.g., prior experi-

ence, specialized interest in product avoidance, consumer literacy,

product appearance, ete., which, according to the testimony of Dr.

Jacob Jacoby, world expert on consumer attention to safety in-

structions, are essential to any expert assessment of the likeli-

hood that food product labels will or will not be read. Dr. Jacoby

testified in support of the motion for preliminary injunction that the

majority of conumers will not read, understand or believe the labels

prescribed by the Rule. While his substantive conclusion is not to

be considered by this Court, his testimony does show the inadequacy

of the administrative record regarding expert analysis of label read-

ing propensities of the broad spectrum of the consuming public.

fact, the rulemaker’s thinking on this point was just the

opposite: ‘‘not too many people read .. . handling in-

structions’? but instead rely on ‘previous experience,’’

App. 97-98. Yet previous consumer experience with hot

dogs, lunch meats and bacon is that unrefrigerated use is

safe. Their nitrite-free, counterpart look alikes authorized

by the Rule are potentially lethal with the same handling.

It follows that even if the Rule were not vulnerable for

‘inadequacy of explanation’, National Nutritional Foods

Assn v. Weinberger, supru, regarding the efficacy of label-

ing, it should fall either for lack of rational support for

any implied conclusion that labeling would suffice to pro-

tect the ordinary consumer under the look alike cireum-

stances permitted by the Rule, Burlington Truck Lines vy.

U.S., 371 U.S. 156 (1956), or for arbitrariness in exposing

consumers to the risk of botulism in the face of the known

inefficacy of cautionary labels.

The fact that the Rule requires the term ‘‘uncured’’ on

the label of nitriteless meats supplies neither the missing

analysis of labeling efficacy nor the rational support for

the Rule demanded by Overton. Recognition of the need

for distinguishing preserved from unpreserved products,

App. 84-85, does not in itself rationally demonstrate that

prefixing the term ‘‘uncured’’ to the traditional name will

differentiate look alike products in the eyes of the ordinary

consumer, Certainly the term will not warn those just men-

tioned who cannot or, relying on ‘‘previous experience’’,

likely will not read the label. Nor will the administrative

record suppor: a finding that those who do read the term

will ‘‘commonly’’ App. 85, understand it to mean no-

nitrite. While it may be true, as indicated by the comments,

that a few with special interest in the nitrite controversy

will understand this term, it is, as the district court ob-

served, irrational to conclude from this ‘‘that the 200 mil-

lion consumers in this country generally share the same

definition.’’ App. 32.7 Certainly, the two comments re-

lied on by counsel in the court below, Comments 55 and

238, do not provide the required record support for the

critical conclusion that consumers universally understand

the term ‘‘uncured’’ to mean ‘‘without nitrite.’ *

Likewise, recognition by the Department that consumers

have safely handled uncured products such as bockwurst

and bratwurst in the past does not supply the missing ra-

tional focus on the efficacy of labeling. Contra App. 12-13.

These products do not take on the appearance of familiar

preserved meats for, as the Department explained, their

‘*basic color difference’’, Tr, 254-7, 260, distinguishes them.

The challenged Rule, however, requires similarity in ap-

pearance and size as well as flavor and consistency, thus

removing not only the color differential but also any size

characteristics that might otherwise serve to distinguish

cured from uncured.’

? Petitioners daresay a poll by the court of its own members and

staff regarding the meaning of the term “uncured” will not yield

results significantly different from those of an informal survey re-

ported by petitioners’ expert at the hearing on the motion for pre-

liminary injunction in which not one among some 250 college and

graduate students and PhDs knew the meaning of this technical term.

Tr. 122-3.

®’ The Department's complete silence as to the basis for its con-

clusion that “uncured” is “commonly” understood to mean nitrite-

free does not come close to meeting the requisite “high standard of

articulation.” Environmental Defense Fund v. EPA, 465 F.2d 528,

541 (D.C. Cir. 1972).

® The court of appeals erroneously separated its analysis of peti-

tioners’ contentions regarding arbitrariness from the similarity re-

quirements. See App. 10-13 and 16-19, The arbitrariness of the Rule

arises precisely from the rulemaker’s failure to consider the likely

impact of the similarity requirements on the effectiveness of the pre-

scribed labeling in preventing confusion and thereby botulism.

In sum, while the rulemaker facially considered” the

question of labeling, his analysis, in clear violation of the

standards set out in Overton, failed to consider, or to draw

articulated, rationally drawn conclusions supported by

record findings regarding the needs of the illiterate, the

non-English speaking, those with impaired sight, those

who have no interest in the nitrite-free meat controversy,

and those exposed to the unpreserved product when the

label is not attached or, in other words, the needs of most

of us. That failing renders the rulemaking arbitrary.

b) Botulism risk

The inadequacy of the Department’s inquiry regarding

the increase of botulism poisoning in the absence of re-

frigerated handling is equally patent.

'* The supposed albeit undemonstrated efficacy of warning labels

and lack of increased botulism risk would appear completely to be

helied by a post-rulemaking official Department publication contain-

ing instruction for safe packing of a child’s lunch of the unpreserved

look alikes permitted under the Rule:

“To pack a safe ‘brown bag’ lunch, use one of these methods:

Prepare and freeze the meat sandwich the evening before. . .

it will thaw in time for lunch. Pack sandwich in a small in-

sulated container such as the commercially available foam plastic.

Double wrap the sandwich and pack it with a cold piece of fruit

or cold can of juice. Put a cold device into the lunchbag. The

device might be a commercial freezer gel, a plastic bag filled with

ice cubes, or a cleaned-out margarine tub that you have filled

with water and frozen.” Exh. 17; Tr. 151,

It deception, injury or confusion would be likely but for an un-

supported general assumption that consumers will read explanatory

information on a label, it is now common ground that the label can-

not stand. Houston v. St. Louis Independent Packing Co., 249 U.S.

479, 487 (1918) ; Federation of Homemakers v. Buts, 466 F.2d 462.

405-6 (D.C. Cir. 1972); Cf. Federal Security Administrator v.

Quaker Oats Co., 318 U.S. 218, 230 (1943).

The court of appeals held that the rulemaker adequately

considered the dangers of botulism by noting in the pro-

posal for rulemaking that reducing or eliminating nitrites

‘‘may better support’’ the production of botulism, App.

10, and by adopting the label requirements included in

the final Rule. App. 11. The Department’s assessment

of increased risk, however, was premised entirely on the

assumption that labeling would be completely effective in

altering existing handling practices and assuring proper

refrigeration:

‘“‘This regulation is not expected to result in any in-

crease in incidence of food poisoning from Clostridium

botulinum toxin types of A & B, those primarily asso-

ciated with red meats. Research has shown that spores

of these types do not generally grow at temperatures

below 40° F.’’ App. 80

The relevant factor, however, was whether an increased

incidence rate was likely should uncured products be han-

dled as their cured counterparts now are at 70°, 80° and

90°F for prolonged periods on picnics, kitchen tables and

camping trips and in lunch pails and school lockers. The

Rule’s statement of bases and purpose simply does not

address this point and nothing found in the court of ap-

peals analysis fills the void.

The Department’s disregard of this relevant factor is

highly material for botulin is a killer toxin, Tr. 21, 101,

and a finding, had it been made, of increased risk would,

absent unfailing safeguards against unrefrigerated han-

dling, if indeed such exist, render the Rule arbitrary on

its face.!' For the same reason, a finding of no increased

11 Even if some extraordinary reason were advanced (and none

was) to justify tolerating a slight increase in risk, the rulemaker's

quantification of the risk and basis therefor would still be highly

relevant to judicial appraisal of the justification.

risk would require a demonstrably ‘‘reasoned decision”.

Wellford v. Ruckelhaus, 439 F2d 598, 601 (D.C. Cir. 1971)

for ‘‘personal interests in life and heaith’”’ are at stake

and ‘‘close judicial scrutiny is particularly appropriate. ’’

Id, Yet no such reasoned analysis appears."? Given this

’* Admissions, made contemporaneously with the rulemaking by

respondents and their agents (if this is what the Government meant

below by “other” relevant material on which the rulemaker was

entitled to rely), would cast doubt on the soundness of any down-

play of the botulism risk if uncured product were exposed to han-

dling now given some cured meats:

“Consumers and food retailers handle cured meat products in

ways that would foster the formation of the botulism toxin—

for example, stores sometimes hold or display these products

without refrigeration and consumers sometimes take them on

camping trips or extended picnics. Without nitrite. such prac-

tices, particularly in combination, could produce botulism in

most people eating it.” FDA’s and USDA’s Action Regarding

Nitrite, Aug. 1978, Pl. Ex. 22, p. 28-29; Tr. 77

“[Without nitrites common usage of such products as hot

dogs and ham would not be possible without severe health

hazards.”

“With current food processing and handling technology and

practices, the protection provided by nitrite is essential to the

public health. Its immediate elimination would subject the

public to a grave risk of botulism.” FDA/USDA Fact Sheet.

March 28, 1979, Pl. Exh. 19, p. 1; Tr. 82.

| Petitioners note that the Rule would effect an “immediate elimina-

tion” of nitrite in the affected products]

“Under current procedures for the manufacture or processing

of food, and the conditions of its distribution and handling . . .

[nitrites and nitrates] are essential to prevent the develop-

ment in some meat food products . . . of a toxin that causes

a deadly form of food poisoning known as botulism.” Def

Bergland, et al., March 30, 1979, Pl. Exh. 20, p. 1; Tr. 890.

(footnote continued )

absence of requisite ‘‘clarity’’, Phelps Dodge Corp v.

NLIJB, 313 U.S. 177, 197 (1941) regarding botulism risk

in the agency’s stated basis of the Rule, this Court cannot

elucidate ‘‘what the agency has left vague and indecisive’’,

(footnote continued )

So would statements contained in the administrative record from

the Department’s Meat & Poultry Advisory Con mittee:

“|T]here is no question . . . that the immediate elimination

of nitrites from the food supply could create a serious, acute

public health hazard in the form of botulism poisoning in some

food products” (Grumbly, Adv. Tr. 21).

“Without nitrites, you do have some special cautions in preser-

vation (Nelson, Adv. Tr. 54).

“Of course, a biggy was a concern for botulism and there were

30 comments that specified botulism directly, I mean, stated

‘Botulism’, in the comment, ‘is a hazard if you proceed.’”

(Nelson, Adv. Tr. 63).

“[W Jithout nitrite, they [meat products] all can develop botu-

lism without refrigeration’’ (Nelson, Adv. Tr. 63).

“[T]here have been surveys made to determine the incidence

of botulinal spores on meat products. I don’t know of any

way to determine that incidence except to have them grow.

Now, it might be, you know, that they were able to grow them

under very good conditions but, once they begin growing, it

doesn’t take long for them to do what they have got to do”

(Nelson, Adv. C. Tr. 66-67).

“(T]oxin can be produced at certain levels of temperature

even though it would be under refrigeration for botulism” (Dr.

May, Adv. Tr. 81-82).

“|Wle are talking about something that literally can kill a

person. It is not a slow process ... It can actually kill you.

It can do it very rapidly” (Dr. May, Adv. Tr. 101).

“(|T]here is plenty of information to show that, even at the

lower levels [of spore load], you still get botulinal toxin pro-

duced, under the right conditions” (Def. Houston, Adv. Tr.

69).

SEC v. Chenery, 332 U. 8. 194, 197 (1947) but must instead

set the Rule aside. U. 8. v. Chicago Milwaukee, St. Paul &

Pac. Ry., 294 U. 8. 499, 510-511 (1935); SEC v. Chenery,

318 U.S. 80, 94-5 (1943).

II,

The Department Exceeded Its Authority

By Promulgating the Rule For an Unlawful Purpose

The district court held that the Rule’s purpose was the

active promotion of markets for uncured products at the

expense of producers of cured products, App. 36. The

court of appeals held that the Department adopted the

Rule to expand the availability of nitrite-free products.

App. 15." In either case the Department has exceeded

its authority.

First, for reasons given, supra 18-22, the Rule’s poten-

tial effect of increasing the incidence of botulism is not

consistent with the public health and welfare, a consistency

which the court of appeals held was required for the

Rule’s purpose to be valid. App. 14.

‘The court of appeals correctly held that the Rule was “not

based on the asserted cancer dangers” of nitrite, App. 15, inas-

much as “not a word”, Rodway v. USDA, 514 F2d 809, 814-815

(D.C. Cir. 1975), about cancer, potential carcinogencity of nitrite

or related compounds, Department cancer policy, consumer con-

cerns about the dangers of nitrites or relevant research appears in

either the final Rule or its preamble. To hold otherwise would have

placed the court in the position impermissibly of “substituting”,

SEC v. Chenery, supra, 332 U. S. at 196; Cf. Tabor v. Joint Board,

supra, its own purpose for that of the agency and of sustaining a

purpose as to which proper notice and opportunity to comment

were not afforded. 5 U.S.C. § 553; Rodway v. USDA, supra,

Wayner Electric Corp. v. Volpe, 466 F2d 1013 (3rd Cir. 1972).

Second, while a favorable competitive impact on one

market segment may be justifiable as incidental and un-

avoidable in the accomplishment of some other congres-

sionally authorized purpose, Cf. Hiatt Grain and Feed, Inc.

\. Bergland, 602 F2d 929, 933 (10th Cir. 1979), cert. dened,

ies U.S. ........ (1980), the direct promotion, as here, of

the interests of nitrite-free product manufacturers at the

expense of competitors as an end in itself is outside the

Department’s statutory.

Finally, the means chosen by the Department to expand

markets and/or consumer availability of nitrite-free prod-

ucts—namely the imposition of similarity requirements—

are irrational. Contra App. 16-19. The court of appeals

argues that these requirements are justified under the

Department’s general authority to establish standards of

identity to prevent confusion and economic adulteration.

App. 17. The obvious effect of the requirements, how-

ever, will, as the district court noted, be just the opposite:

‘*OContrary to the purposes of the standards, the simi-

larity requirements will confuse, if not deceive, con-

sumers as to the identity of the products they are re-

ceiving and the handling requirements of those prod-

ucts.’’ App. 39.

That confusion will not only be detrimental to expansion

of the nitrite-free product market but will be disastrous

to the market for nitrite-preserved products, especially

in the event of a botulism fatality resulting from the

confusion.

It is no answer to say without further analysis as did

the court of appeals App. 17, that the authority for the

present rulemaking falls within the Department’s general

ingredient or label approving power. No doubt that gen-

eral authority exists. But it does not include the power

to exercise such authority arbitrarily or irrationally.

ITT.

This Court Should Resolve the Conflict

Between the Circuits Regarding the Requirements

of the National Environmental Policy Act

The Second, Seventh and District of Columbia Circuits,

among others, hold that the National nvironmental] Policy

Act of 1969, 42 U.S.C. §4321 et seq (NEPA) and The Coun-

cil on Environmental Quality, 40 C.F.R. 1500 et seq, re-

quire a rulemaker who determines not to file a draft and

final environmental impact statement (EIS) to assess all

relevant factors considered in that determination, state

its reasons for not preparing an EIS, and affirmatively

develop a reviewable administrative record in support of

the decision not to file an KIS. Trinity Episcopal School

Corp v. Romney, 523 F2d 88, 93 (2nd Cir, 1975) ; Scientists

Institute for Public Information v. Atomic Energy Com-

mission, 481 F2d 1079, 1094-5 (D.C. Cir. 1973) ; Nucleus of

Chgo. Homeowner Assn v. Lynn, 524 F2d 225, 231 (7th

Cir. 1975), cert denied, 426 U.S. 939 (1976); see 40 C.F.R.

1501.4(c) and (e) and 1508.13.

The present rulemaking, conceded by the Department to

be of ‘‘major’’ character, App. 93, includes neither an

KIS, consideration of factors (such as label reading prac-

tices of ordinary consumers) relevant to a decision not to

file an EIS, reasons for not preparing an EIS, nor a de-

veloped record to justify not filing.

The Eighth Circuit excused this complete disregard of

NEPA and in doing so is in direct conflict with other cir-

cuits, mentioned above, which construe NEPA to require

setting aside rulemaking under such circumstances. The

court of appeals does not deny that the Department dis-

regarded NEPA but says instead that the court is able

to sift out from the rulemaking record evidence of De-

partment attention to health dangers. App. 19-20. That,

however, is in the manner of a forbidden post-hoe ration-

alization. Citizens to Preserve Overton Park v. Volpe,

supra, 401 U. S. at 419-420; FPC v. Texas, 417 U. S. 380,

397 (1974); Tabor v. Joint Board, 566 F2d 705, 709-710

(D.C. Cir. 1977) and is not the court’s function, U/. S. v.

Chgo. Milwaukee, St. Paul & Pac. Ry., supra. With NEPA,

as with any other aspect of agency rulemaking, it is for

the agency to state its grounds and the court merely to

review them. ‘‘If those grounds are not ‘‘clearly dis-

closed’’, SEC v. Chenery Corp., supra, 318 U.S. at 94, the

Rule cannot be sustained.

This Court should resolve the conflict in favor of the

other circuits. In so resolving the conflict, this Court will

assure the full analysis, ‘‘reasoned decision’’ and ‘‘balanc-

ing’’ of risks, Karlen v. Harris, 59) F2d 39, 44 (2nd Cir.

1978) commanded by Congress but absent here and there-

by forestall substantial health hazards such as those cre-

ated by the present rulemaking.”

The Final Impact Statement prepared by the Department,

App. 72-82, is not equivalent to an EIS. App. 46; See 43

Fed. Reg. 21987 (May 22, 1978); Cf. 39 Fed. Reg. 18680 (May

29, 1974), CEQ Regulations 40 C.F.R. 1502.10 (1978) ; Cf. Greene

County Planning Board vy. FPC, 455 F2d 412 (2nd Cir.) cert.

denied, 409 U.S. 849 (1972); Steubing v. Brinegar, 511 F2d 489

(2nd Cir. 1975); S. W. Neighborhood Assembly v. Eckard, 445

F. Supp. 1195 (D.D.C. 1978). Moreover, the FIS was markedly

less sensitive to environmental effects significantly impacting the

public health, National Organization for Reform of Marijuana Laws

v. U. S., 452 F. Supp. 1226 (D.D.C. 1978) and less exacting in

its analysis than the duty under NEPA to file an EIS or to leave

a visible explanation for not filing. Scientists’ Institute for Public

Information, Inc. v. AEC, supra.

CONCLUSION

Petitioners do not ask that this Court usurp the agency

function or second guess well supported conclusions

reached by the agency. Petitioners do not ask that this

Court determine for itself whether the labeling system

adopted by the agency will or will not be efficacious to pre-

vent confusion under the look and name alike cireum-

stances authorized by the Rule or whether the risk of

botulism will be greatly or minimally increased in the

event of such confusion. Overton Park and Vermont

Yankee forbid such judicial intrusion.

Petitioners do, however, earnestly urge that this Court

affirm the district court’s strong conclusion that the rule-

maker failed by a long measure adequately to examine the

relevant factors of label efficacy and botulism risk, reach

reasoned conclusions regarding them, and make and articu-

late findings based on the administrative record which lend

credible support to those conclusions.

It may well be true that the administrative record will

support a conclusion that members of an elite subgroup

who read labels in exercising their personal preferences

for additive-free food are not jeopardized by the Rule.

But what is to happen to the rest of us? Petitioners be-

lieve Section 706(2)(A) was enacted by Congress to as-

sure protection of the latter as well as the former and

that this Court will not hesitate to provide Congressionally

mandated review when as here agency rulemaking is arbi-

trary and capricious on its face.

Wuererore, Petitioners respectfully request that the

writ issue.

Respectfully submitted,

DonaLp P. CoLLEetTon

James L. Fox

Attorneys for Petitioners,

CuHarLes GrassLEy, THomas HaGEpornN,

NatTionaL Pork Propucers CouncliL,

and Srever Syms

Of Counsel:

ApramMson & Fox

One East Wacker Drive

Chicago, Illinois 60601

(312) 644-8500

APPENDIX

UNITED STATES COURT OF APPEALS

For The Highth Circuit

No. 80-1229

National Pork Producers Council, an Iowa corporation;

Charles Grassley; Tom Hagedorn; and Steven Symms;

and National Independent Meat Packers Association,

Appellees.

Bob Bergland, Secretary of Agriculture; Carol Tucker

Foreman, Assistant Secretary of Agriculture for Food and

Consumer Services; and Donald Houston, Acting Admin-

istrator, Food Safety and Quality Service, United States

Department of Agriculture,

Appellants.

Appeal from the United States District Court

for the Southern District of Iowa.

Submitted: June 13, 1980

Filed: September 23, 1980

Before HEANEY and BRIGHT, Circuit Judges, and

HUNGATE, District Judge.*

HEANEY, Circuit Judge.

This appeal presents the question of whether the United ,

States Department of Agriculture (USDA) properly exer-

cised its authority when it issued regulations permitting

* The Honorable WILLIAM L. HUNGATE, United States Dis-

trict Judge, Eastern District of Missouri, sitting by designation.

App. 2

nitrate and nitrite-free meat products to be sold under

product names traditionally reserved for foods containing

these compounds. The district court held that it did not.

We reverse.

The history of nitrate and nitrite use in curing meat and

poultry products is a long one. As early as Homer’s time

(900 B.C.), curing meat with salt was an established prac-

tice. Although it surely was not known at the time, the

desert salts used in the curing process contained nitrate

impurities, which caused cured meat to develop a charac.

teristic spicy flavor and pink color. In addition, the curing

process helped preserve the meat from bacteria! spoilage.

The cure was particularly effective, it is now known, in

inhibiting the growth of Clostridium botulinum, the bac-

teria that produce the deadly toxin responsible for the

food poisoning known as botulism.

Although curing is a centuries-old practice, it was not

until the first part of the twentieth century that scientists

identified the active agent responsible for the cure. The

color, flavor and preservative effects were caused by the

meat’s reaction with nitric oxide, which was formed from

nitrite, which was, in turn, formed from the nitrate used

in the curing process. Because these reactions are difficult

to control when meat products are cured with nitrate, the

USDA formerly authorized the direct addition of nitrite

in 1925. In some products, such as bacon, some form of

nitrite is required by USDA regulations. See 9 C.F.R.

§ 318.7(b) (1980). Because nitrite was recognized as po-

tentially toxic, however, a maximum residual amount of

200 parts per million was established. Nitrate was not di-

rectly regulated.

In the late 1960’s, concern developed over nitrite use

as studies suggested that nitrites combined with other

compounds in the food or in the body to form nitrosamines,

App. 3

which were known to be potent carcinogens in animals. As

one report presented to a Senate Committee indicates, the

possibility that nitrites could cause cancer touched off a

flurry of activity:

In October 1969, meat industry scientists met with the

Assistant Secretary of Agriculture to discuss the pos-

sibility of a nitrosamine problem existing in U.S.

cured meat products. In December of 1969, a group

of USDA, FDA, and industry scientists met to dis-

cuss the problem, resulting in the scheduling of a co-

operative research program to be funded by industry

and actively participated in by industry, DA, and the

Department. The Food and Drug Administration

(FDA) and the U.S. Department of Agriculture or-

ganized a scientific study group to review appropriate

information and data. In 1971, the House Intergovern-

mental Relations Subcommittee conducted hearings on

the issue of nitrosamine formation and the possible in-

volvement of nitrite in cured foods. The matter was

widely discussed by the public and the media, and fur-

ther studies were carried out by the scientific com-

munity. Numerous conferences were held during 1972,

to discuss available information on the role of nitrite

in curing and preserving, and to determine what new

information was needed.

Because of the widespread interest in the subject,

the Secretary appointed an Expert Panel in 1973 to

assess the data concerning the presence of nitrosam-

ines in foods, to evaluate the public health significance

and specific problems identified with the use of nitrites

in foods, and to determine if alternate methods of pro-

cessing were available.

Agriculture, Rural Development, and Related Agencies

Appropriations for Fiscal Year 1979: Hearings before a

Subcomm. of the Senate Comm. on Appropriations, 95th

Cong., 2d Sess. 2936, 2937 (1978) (Final Report on Nitrites

App. 4

and Nitrosamines to the Secretary of Agriculture by the

Expert Panel on Nitrites and Nitrosamines).

One conclusion of the new round of studies was that

nitrosamines are formed in nitrite-cured bacon when it is

fried at high temperatures, particularly if it is cooked

until crisp. As a result, in 1978, the USDA promulgated

revised regulations that reduced the permissible levels of

nitrite in bacon, required that other additives be used to

lessen the likelihood that nitrosamines would form, and

established procedures for testing bacon to ensure that it

contains no confirmable levels of nitrosamines after cook-

ing. 9 C.F.R. § 318.7(b) (1980); see American Meat Inst.

v. Bergland, 459 F.Supp. 1308 (D. D.C. 1978).

Another, more tentative, conclusion of the scientific

studies on nitrate and nitrite use was stated in 1978 by

Paul Newberne of the Massachusetts Institute of Tech-

nology. The Newborne Report determined that nitrites

themselves caused cancer in laboratory animals, even if

nitrosamines had not formed prior to ingestion. This re-

port prompted a wave of criticism from the meat industry

on the one hand, and resulted in increased pressure on the

USDA to completely ban the use of nitrites on the other.

The Department resisted these pressures, however, find-

ing that greater scientific study was required.’ See Schuck

v. Butz, 500 F.2d 810 (D.C. Cir. 1974).

1 Following the release of the 1978 Newberne Report, the FDA

and the USDA established an Interagency Working Group on

Nitrite Research to evaluate the MIT study. The interagency

group, composed of scientists from the FDA, the USDA, the Na-

tional Cancer Institute and the National Institute of Environmental

Health Sciences, evaluated the design and conduct of the study and

ordered an intensive pathology review of Dr. Newberne’s diagnoses.

Tn a report dated August 15, 1980, the group announced their find-

ings, concluding that “insufficient evidence exists to support the

(footnote continued)

App. 5

As the USDA and FDA studies continued, public aware-

ness of the problem resulted in increased consumer de-

mand for nitrate and nitrite-free products. USDA regula-

tions, however, prohibited the production, saie or distribu-

tion of nitrate and nitrite-free products under their tradi-

tional names such as frankfurters, bacon, ete. As a result,

consumers complained of some difficulty in identifying or

finding the products they desired.

The Food Safety and Quality Service of the USDA re-

sponded to these complaints on April 28, 1978, by publish-

ing a notice of proposed rulemaking in the Federal Regis-

ter. 43 Fed.Reg. 18,193 (1978). In this notice, the USDA

proposed to amend the federal meat inspection regulations

to permit the sale of nitrate and nitrite-free products under

their traditional names, provided that certain labeling and

quality requirements were met.

In the sixty-day comment period following notice of the

proposed rule, the USDA received 365 comments from in-

dividual consumers, consumer organizations, and industry

and trade associations. In addition, the USDA consulted

the National Advisory Committee on Meat and Poultry

(footnote continued )

conclusion that sodium nitrite per se fed to rats causes cancer,

based on the MIT study.” The FDA and USDA announced in

a news release accompanying the report that they have decided

to contract with the National Academy of Sciences to review all

relevant data on nitrite before additional action is taken. The

agencies stated that the National Academy of Sciences “will conduct

an independent assessment of all available scientific information

about nitrite and will analyze scientific data and develop a research

agenda on potential alternatives to nitrite as a preservative in meats

and poultry.” The release concluded: “Because of its widespread

usage, we believe that our agencies must continue to be concerned

about the effects, if any, that nitrite consumption might have on the

public’s health.”

App. 6

Inspection about the proposal and the comments. On June

14, 1979, the USDA issued a Final Impact Statement on

the proposed rule, detailing the need for the rule, the Oop-

tions considered, and the expected impact of its implemen-

tation. On August 21, 1979, the USDA promulgated the

final regulation, to be effective September 20, 1979. See 9

C.F.R. §§ 317.17(b) & (c), 318.7, 319.2.2 The final rule pro-

vides that meat and meat products that are not cured with

nitrates, nitrites or other preservatives may be sold under

their traditional names, so long as the word ‘‘Uncured”’

appears on the label as part of the product name and the

label states: ‘‘No Nitrate or Nitrite Added’’ and ‘‘Not

Preserved—Keep Refrigerated Below 40° F. At All

Times.’’ In addition, the regulation requires that the un-

cured products be similar in size, flavor, consistency and

general appearance to the products commonly prepared

with nitrate or nitrite.’

29 C.F.R. § 318.7, which prohibits the use of nitrates or nitrites

in baby, juaior or toddler foods, is not being challenged in this

action.

* The final regulations in question read as follows:

§ 317.17. Interpretation and statement of labeling policy

for cured products; special labeling requirements concerning

nitrate and nitrite.

** * *

(b) Any products, such as bacon and pepperoni, which is

required to be labeled by a common or usual name or descrip-

tive name in accordance with § 317.2(c)(1) and to which

nitrate or nitrite is permitted or required to be added may be pre-

pared without nitrate or nitrite and labeled with such common

or usual name or descriptive name when immediately preceded

with the term “Uncured” as part of the product name in the

same size and style of lettering as the product name, provided

that the product is found by the Administrator to be similar

in size, flavor, consistency, and general appearance to such

(footnote continued )

App. 7

On September 20, 1979, the National Pork Producers

Council, a trade organization representing approximately

92,500 United States pork producers, tugether with three

members of the United States House of Representatives,

(footnote continued )

product as commonly prepared with nitrate or nitrite, or both.

(c)(1) Products described in paragraph (b) of this sec-

tion or § 319.2 of this subchapter, which contain no nitrate or

nitrite shall bear the statement ‘No Nitrate or Nitrite Added.”

This statement shall be adjacent to the product name in letter-

ing of easily readable style and at least one-half the size of the

product name.

(2) Products described in paragraph (b) of this section

and § 319.2 of this subchapter shall bear, adjacent to the

product name in lettering of easily readable style and at least

one-half the size of the product name, the statement “Not

Preserved——-Keep Refrigerated Below 40° F. At All Times”

unless they have been thermally processed to F° 3 or more;

they have been fermented or pickled to pH or 4.6 or less; or

they have been dried to a water activity of 0.92 or less.

(3) Products described in paragraph (b) of this section

and § 319.2 of this subchapter shall not be subject to the

labeling requirements of paragraphs (b) and (c) of this

section if they contain an amount of salt sufficient to achieve

a brine concentration of 10 percent or more.

* * %*

§ 319.2 Products and nitrates and nitrites.

Any product such as frankfurters and corned beef, for which

there is a standard in this part and to which nitrate or nitrite

is permitted or required to be added, may be prepared without

nitrate or nitrite and labeled with such standard name when

immediately preceded with the term “Uncured” in the same size

and style of lettering as the rest of such standard name:

Provided, That the product is found by the Administrator to

be similar in size, flavor, consistency, and general appearance

to such product as commonly prepared with nitrate and nitrite:

And provided further, That labeling for such product complies

with the provisions of § 317.17(c) of this subchapter.

9 C.F.R. §§ 317.17, 319.2 (1980).

App. 8

filed this lawsuit challenging the regulations. The National

Independent Meat Packers Association, a trade associa-

tion representing approximately 300 meat packers. was

subsequently granted leave to intervene as a party plain-

tiff. The plaintiffs sought declaratory and injunctive

relief.

On February 12, 1980, the district court entered a final

order permanently enjoining the government from enfore-

ing or applying the challenged regulations.‘ The court

rested its decision on four grounds:

(1) The Secretary of Agriculture acted arbitrarily

and capriciously because he failed to consider whether con-

sumers would be subjected to botulism poisoning if they

were to handle uncured products in the fashion in which

they now handle cured products, and because there was

no rational basis in the record for assuming that the re-

quired labels would effectively prevent confusion between

the two types of products.

(2) The Secretary exceeded his authority under the

Federal Meat Inspection Act, 21 U.S.C. § 601 et seq., be-

cause the regulation was promulgated for the unlawful

purpose of promoting or encouraging a market for nitrate

and nitrite-free products.

(3) The Secretary exceeded his authority because the

similarity requirement bore no rational relationship to

the purposes of the Federal Meat Inspection Act and be-

cause it constituted a subjective standard of identity rather

than an objective recipe or formula.

‘The district court had earlier denied a motion for a temporary

restraining order, but had granted a motion for a preliminary in-

junction.

App. 9

(4) The Secretary failed to comply with the require-

ments of the National Environmental Policy Act, 42 U.S.C.

$ 4321 et seq., because he neither filed nor considered the

need for an Environmental Impact Statement (KIS).*

Before discussing in detail the reasoning of the district

court, we briefly consider the appropriate standard for

reviewing regulations, such as these, promulgated pursu-

ant to the ‘‘notice and comment’’ provision of the Admin-

istrative Procedure Act, 5 U.S.C. § 553(¢). The standard

‘is that specified by 5 U.S.C. § 706(2)(A), which

authorizes a reviewing court to set aside agency action

found to be ‘arbitrary, capricious, an abuse of discretion,

or otherwise not in accordance with law.’ ’’ Independent

Meat Packers Ass’n v. Butz, 526 F.2d 228, 238 (8th Cir.

1975), cert. denied, 424 U.S. 966 (1976). Furthermore,

‘‘ynless an inadequate evidentiary development before the

agency can be shown and supplemental information sub-

mitted by the ageney does not provide an adequate basis

for judicial review, the court * * * should limit its inquiry

to the administrative record already in existence supple-

mented, if necessary, by affidavits, depositions, or other

proof of an explanatory nature.’’ 7d. at 239. The district

court explicitly recognized this standard in its opinion,

but it nevertheless held a hearing that included the presen-

tation of some evidence beyond ‘‘proof of an explanatory

nature.’’ We turn now to an independent examination of

the record to determine whether the USDA acted arbi-

trarily, capriciously, or otherwise not in accordance with

law.

5Jn addition, the court rejected the plaintiffs’ contention that the

nitrate and nitrite-free products must be labeled “imitation” in ac-

cordance with 21 U.S.C. § 601(n)(3) finding that the uncured

nroducts were not imitations of their cured counterparts.

App. 10

A. Arbitrary and capricious action.

The district court’s reasons for holding that the Secre-

tary’s action was arbitrary and capricious were that the

USDA failed to consider whether consumers would be sub-

jected to botulism poisoning if they were to handle uncured

products in the same manner they now handle cured prod-

ucts and whether the labeling requirements would elimi-

nate the risk. We find these rationales unconvincing.

First, it is clear from the record that the USDA was

very concerned with the possible problem of botulism

poisoning. The dangers of botulism and the handling prac-

tices necessary to ensure safety were carefully considered

by the Secretary. As noted earlier, the USDA and other

governmental agencies have been studying the health ef-

fects of nitrates and nitrites at least since the 1960's.

These agencies have been looking for alternative preserva-

tives and have sought ways to make nitrates and nitrites

less dangerous without destroying their ability to control

the growth of Clostridium botulinum. When the agency

promulgated regulations to reduce the levels of nitrites in

bacon, it reduced them only to the lowest level thought

necessary to control these bacteria. More importantly, the

agency expressly recognized the potential botulism danger

in the official documents in this administrative proceeding.

The notice of proposed rulemaking stated:

The Administrator recognizes that meat products

prepared without nitrate and/or nitrite or with re-

duced levels of nitrate and/or nitrite may better sup-

port the growth and toxin production of Clostridium

botulinum that [sic] meat products prepared with the

traditional levels of nitrate and/or nitrite currently

permitted by regulation * * *. Clostridium botulinum

intoxication (botulism) is a type of food poisoning

which often causes death.

App. 11

43 Fed.Reg. 18,193 (1978).

Similarly, the explanation accompanying the final rule re-

flected the agency’s awareness of the dangers of botulism

and the value of nitrites in reducing that danger. See 44

Fed.Reg. 48,959 (1979). Indeed, it was this awareness that

prompted the strict labeling requirements in the regula-

tions.

The agency was not only fully aware of the botulism

risk, it considered evidence of the effect of the proposed

regulation, particularly the labeling requirements, on that

risk. It noted that some of the 365 comments submitted

to it ‘‘expressed concern whether such labeling provisions

would be adequate to protect against botulism with respect

to * * * unpreserved products. In this connection, some

commentators questioned whether products would always

be handled in accordance with the warnings on the labeling

and be kept below 40° F’.’’ 44 Fed.Reg. 48,959 (1979).

Nevertheless, the agency found persuasive evidence that

the benefits of the regulation would outweigh any potential

safety problem. Many of the comments demonstrated con-

sumer awareness of the potential dangerous consequences

of marketing and consuming meat products that do not

contain nitrates or nitrites. Many commentators referred

to the positive safe experiences they had had with pur-

chasing uncured products in the past. Others stated that

their knowledge of food products came from a careful

reading of product labels. Still others indicated an under-

standing of the term ‘‘uncured’’ and expressed a willing-

ness to adhere to the instructions on the label in exchange

for an opportunity to buy meat products without nitrates

or nitrites. Indeed, even the comment of the plaintiff-

* The public record also supports the proposition that consumers

have become increasingly aware of the role of nitrates and nitrites

in preserving meat products.

App. 12

congresspersons in this action recognized the efficacy of

warning labels; the congiesspersons suggested, inter alia,

that a revised regulation require strict warning labels.

Moreover, not only was the agency aware of the botulism

danger at the outset, and not only did it consider further

evidence of the danger, once it reviewed the evidence, it

took positive steps to eliminate the chance of any danger

resulting from the regulations. The final rule differed

from the proposed rule in two significant respects. First,

the labels on nitrate or nitrite-free products were required

to contain the word ‘‘Uncured’’ as part of the product

uname, The agency described its reasons for the change as

follows:

(T jhe Administrator has determined, based on the

comments, that the use of nitrates and nitrites is of

such importance in products preserved by these sub-

stances, that products prepared without such sub-

stances should have different names from those pre-

pared with nitrates or nitrites in order to more clear-

ly distinguish such products. Under these circum-

stances, it has been determined that such products

prepared without nitrates or nitrites may bear the

traditional name, but that the traditional name must

be preceded by the term ‘‘Uncured.’’

44 Fed.Reg. 48,959 (1979).

Second, the proposed rule had permitted the sale, under

traditional names, of products with low nitrate levels if

they were labeled ‘‘Not Fully Preserved, Must Be Re-

frigerated Below 40° F. At All Times.’’ This provision

was deleted, partly in response to concern about whether

‘‘consumers might misuse such products not otherwise

preserved, based on a false assurance that the listing of

nitrates or nitrites in the ingredients statement would be

understood to represent that products could be handled

under the same circumstances acceptable for products

fully preserved by nitrates or nitrites.’’ Id. at 48,960.

App. 13

These changes in the regulation are further proof that

the agency carefully considered the evidence of botulism

risk and made a reasoned determination in response to

that evidence.’

After considering the submitted comments, consulting

the Advisory Commission, and reviewing the relevant

evidence before it, the agency made the following state-

ment:

The Administrator * * * is aware that products

requiring such special handling such as pork sausage,

bratwurst and bockwurst have presented no apparent

health hazards even though prepared without nitrates

or nitrites and marketed unfrozen. He concludes that

consumers have demonstrated a knowledge of the han-

dling practices necessary for any of such products

prepared without nitrates or nitrites and that the pre-

scribed labeling for such products. i.e., ‘‘Not Pre-

served—Keep Refrigerated Below 40° F. At All

Times,’’ will adequately inform the consumer of how

to maintain such products in a wholesome condition

until consumed.

Id.

Although the record contains some evidence that would

suggest a different conclusion, we cannot say that the

Secretary’s determination is without basis in the record.

Accordingly, the district court erred in holding that the

Secretary acted arbitrarily and capriciously in promul-

gating these regulations.

B. Unlawful purpose.

The district court determined that the Secretary was

without authority to promulgate the regulations in ques-

tion because they were issued for the unlawful purpose

‘To further guard against any botulism risk, the USDA printed,

primarily for distribution to consumers in supermarkets, educational

pamphlets warning of the handling requirements of uncured products.

App. 14

of promoting a market for uncured products. In support

of this position, the district court quotes the Final Impact

Statement released by the USDA on June 14, 1979, which

states that one of the purposes of the regulations is ‘to

allow the use of familiar names for the traditional, but

nitrite-free processed meat products. Allowing these prod-

ucts to be marketed by traditional names will increase

consumer awareness of their availability as well as con-

sumption by those wishing to forego consumption of nitrite

cured products.’’ In addition, the court noted that the

agency considered continuing the prohibition on the use

of traditional product names on meat products without

nitrates or nitrites, but rejected this option because ‘‘it

does not facilitate the development of markets for nitrate

and/or nitrite-free products.’’ This, the court concluded,

proves that the agency acted with an improper purpose.

We disagree. Congress expressly charged the USDA

with ‘‘assuring that meat and meat food products dis-

tributed to [consumers] are wholesome, not adulterated,

and properly marked, labeled, and packaged.’’ 21 U.S.C.

§ 602. In our view, this directive authorizes the Depart-

ment to ensure that the products desired by consumers be

made available to them in a form and manner consistent

with the public health and welfare. Every time the Seecre-

tary approves a product’s ingredients or label, he, in one

sense, is promoting that product. To be sure, the agency

should not be promoting a particular company or a par-

ticular product of a particular company, but merely ful-

filling consumer desires, while ensuring consumer health

and safety, does not constitute such unlawful promotion.

The district court overlooked the agency’s statement,

both in the rulemaking notice and the explanation accom-

panying the final rule, that the regulations were proposed

in response to requests by individual consumers, consumer

interest groups and manufacturers. The comments sup-

App. 15

port the agency’s determination that nitrate and nitrite-

free products were difficult to locate or not available to

consumers. The regulation bears a rational relationship

to this claimed purpose of availability.

Moreover, contrary to what the appellees would have us

think, the preducers of nitrate and nitrite-free preserved

products have no right to be free from competition. See

Hiatt Grain & Feed, Inc. v. Bergland, 602 F.2d 929, 933

(10th Cir. 1979), cert. denied, 62 L.Ed.2d 755 (1980). See

also Westport Taai Serv., Inc. v. Adams, 571 F.2d 697, 700

n.3 (2d Cir.), cert. denied, 439 U.S. 829 (1978). The chal-

lenged regulation is actually an exception to USDA regu-

lations that formerly prohibited selling nitrate and nitrite-

free products under their traditional names. The pro-

ducers of nitrited products enjoyed a benefit from the old

rule, but they have no vested right in the continuation of

it. Upon the Secretary’s finding that it was in the public

interest to permit marketing under traditional names, the

competitive effect on the producers of nitrate and nitrite-

preserved products is of no consequence.

Finally, we emphasize the modest nature of the USDA

proposal. Despite sustained pressure to ban the use of all

nitrites,® the agency determined that regulations permit-

* The district court stated that the public health threat from

nitrite-induced cancer could not be considered as a valid purpose

tor the rule, because the USDA did not indicate in the final rules

that the regulations’ purpose was cancer prevention. We note that

the failure to mention the alleged carcinogenic effects of nitrites was

probably no accident. While the agency was studying the proposed

rule, the United States Attorney General, in response to a USDA

request, issued an opinion stating that if nitrites were found to be

carcinogenic in animals, current law would require the USDA to

ban their use in food products. See 43 Op. Att’y Gen. 1 (1979).

Because scientific studies were not complete, the Secretary wisely

decided to promulgate regulations not based on the asserted cancer

dangers.

—

App. 16

ting the sale of nitrate and nitrite-free products under

traditional names would be sufficient to serve the public

interest at this time. Under the new rules, no meat packer

is required to manufacture nitrate and nitrite-free prod-

ucts, no wholesaler is required to supply them, and no

retailer is required to stock them. Furthermore, the pro-

duction and sale of nitrate and nitrite-preserved products

are unaffected. In short, we conclude that the regulations

are a rational response to the legitimate requests of con-

cerned consumers and were not promulgated for an un-

lawful purpose.

C. Similarity requirement.

The district court’s third rationale for invalidating the

USDA regulations was that the requirement that uncured

products be similar in size, flavor, consistency and general

appearance to their cured counterparts was contrary to

law. The court gave three reasons for this holding.

First, the court determined that ‘‘the similarity require-

ment is a standard of identity that bears no rational rela-

tionship to the purpose of such standards.’’ In support

of this assertion, the district court cited several cases pur-

porting to define the purpose of the identity standards

provisions of the Meat Inspection Act, 21 U.S.C. § 607(e).

The court read these cases as holding that the purpose of

such standards is to prevent the ‘‘economie adulteration”?

or to promote the ‘‘integrity’’ of meat food products. The

similarity requirement in the challenged regulation does

not serve this purpose, the court concluded, because it

‘will confuse, if not deceive, consumers as to the identity

of the products they are receiving and the handling re.

quirements of those products.”’

We cannot agree that the similarity requirement bears

no rational relationship to the purposes of identity stan-

App. 17

dards as intended by Congress. Initially, we note that

none of the cases cited by the court involved successful

challenges to USDA standards of identity. Most impor-

tantly, we think it clear that Congress intended the USDA

to have the authority to issue the type of regulation here

in question. Section 21 of the Act, 21 U.S.C. § 621, gives

the agency broad authority to implement the statute:

‘“‘[The] Secretary shall * * * make such rules and regula-

tions as are necessary for the efficient execution of the

provisions of this Act.’’ Section 7(c) of the Act, 21 U.S.C.

$ 607(c), specifically provides that the Secretary may pre-

scribe labeling requirements ‘‘to avoid false or misleading

labeling’’ as well as definitions an' standards of identity

or composition ‘‘whenever he determines such action is

necessary for the protection of the public.’’ In our view,

the similarity requirement is well within these powers

granted the Secretary by Congress. It is designed to pre-

vent the sale of products under traditional names when

those products bear no resemblance to items commonly

sold under those names. When a consumer buys a product

labeled ‘‘Uncured Hot Dog,’’ he will receive a product

similar to any other ‘‘Hot Dog.’’ Thus, the requirement

furthers the goals of the Act by promoting truthful label-

ing.

The second reason given by the district court for hold-

ing the similarity requirement unlawful is that it

‘fis a subjective standard of identity that is beyond the

[USDA’s] authority to promulgate or enforce.’’ The court

offers no authority for this proposition, however, other

than to say that a standard of identity ‘‘normally sets

forth a ‘recipe’ for a food.’’ (quoting American Frozen

Food Inst. v. Mathews, 413 F.Supp. 548, 554 (D. D.C. 1976),

aff’d on other grounds, 555 F.2d 1059 (D.C. Cir. 1977)).

App. 18

We find this reasoning unpersuasive. As noted earlier,

the statutory grant of authority to the Secretary is broad,

and no restrictions on the permissible types of standards

are contained in the statute. The Secretary’s implementa-

tion of the Act shows that subjective standards were con-

templated; a number of current USDA regulations specify

standards of identity that are not based on objective eri-

teria. See, e.g., 9 C.F.R. § 319.15(c) (‘Beef Patties’’—

‘‘Binders [and other ingredients may be added| only in

amounts such that the product characteristics are essen-

tially that of a meat pattie.’’); §§ 319.15(e) & 319.29

(‘‘Partially defatted beef fatty tissue’? & ‘‘Partially de-

fatted pork fatty tissue’’—‘Such product shall have a

pinkish color and a fresh odor and appearance’’); § 319.80

(‘Barbecued Meats’’—must have ‘‘the usual character-

isties of a barbecued article’); § 319.181 (‘‘Cheesefurters

and similar products’’—‘‘resemble frankfurters except

that they contain sufficient cheese to give definite charac-

teristics to the finished article.’’); § 319.700(a)(3) (iv)

(‘‘Oleomargarine or margarine’’—may contain ‘‘[a]ny

safe and suitable artificial flavoring substance that imparts

to the food a flavor in semblance of butter.’’). The dis-

trict court disregarded these regulations, noting that the

Administrator of the USDA’s Food Safety and Quality

Service told the Advisory Committee that the Department

did not regulate flavor and taste. This reliance on the

comment of the Administrator is misplaced; the regula-

tions speak for themselves. The court apparently was per-

suaded by the difficulty in enforcing subjective standards,

and it may well be that the Administrator would wish to

avoid such standards for that reason. Nevertheless, if the

Secretary decides he is willing to assume the burden of

enforcing this subjective standard of identity, it is not

for us to say it would be too difficult.

App. 19

The district court’s final reason for invalidating the

similarity requirement is that it ‘‘is so unorthodox and

contrary to previous USDA policy and practice that it

was incumbent upon defendants to give a reasoned expla-

nation for their decision to impose the requirement.’’ The

soundness of this reasoning, obviously, is dependent upon

the validity of the district court’s finding that the USDA

had not previously established subjective standards of

identity for food products. For the reasons stated above,

we are satisfied that the Secretary has set such standards

in the past. Accordingly, the district court’s third ration-

ale for holding the similarity requirement invalid must

fall.

D. EIS requirement.

Section 102(2)(C) of the National Environmental Policy

Act, 42 U.S.C. § 4332(2)(C), provides in part that a fed-

eral agency must prepare a ‘‘detailed statement,’’ com-

monly known as an EIS, whenever it proposes ‘‘major

Federal actions significantly affecting the quality of the

human environment.’’ ‘he district court held that the

USDA did not fulfill the requirements of the Act when it

promulgated the regulations involved in this case because

it failed ‘‘to make a determination as to whether an EIS

should have been prepared and [it failed] to develop a

reviewable administrative record supporting a negative

decision * * *,”’

We are not willing to find the regulations infirm on

this basis. The EIS requirement of 42 U.S.C. § 4332(2)(C)

is triggered when an agency proposes major federal action

‘‘significantly affecting the quality of the human environ-

ment.’’ In this case, the record does not support a finding

that such environmental effects may result from imple-

App. 20

mentation of the regulations; moreover, it is clear that

the agency considered the potential for such effects. The

only ‘‘environmental’’ effects mentioned by the district

court were the ‘‘significant public health concerns * * *

implicated by the regulation.’’ As detailed earlier in this

opinion, however, the record shows that the USDA gave

full consideration to the question of the regulations’ health

effects and determined that no significant health dangers

were presented. Consequently, the sole ground for finding

the existence of a major federal action ‘‘significantly af-

fecting the quality of the human environment”’ is unsup-

ported, and no KIS need be filed.

The decision of the district court is reversed.

A true copy.

Attest:

CLERK, U. 8S. COURT OF APPEALS,

EIGHTH CIRCUIT.

App. 21

UNITED STATES DISTRICT COURT

For The

SOUTHERN DISTRICT OF [OWA—

CENTRAL DIVISION

NATIONAL PORK PRODUCERS COUNCIL, et al,

and

NATIONAL INDEPENDENT MEAT PACKERS

ASSOCIATION,

vs.

BOB 8S. BERGLAND, et al

Civil Action File No. 79-431-C

JUDGMENT

This action came on for hearing before the Court, Honor-

able W. C. Stuart, United States District Judge, presiding,

and the issues having been duly (heard) and a decision hav-

ing been duly rendered,

It is Ordered and Adjudged that 9 C.F.R. $317.17 (b)

and (c) and $319.2, 44 Fed. Reg. 48961 (August 21, 1979)

hereby are declared to be arbitrary, capricious, an abuse

of discretion and otherwise not in accordance with law;

It IS FURTHER ORDERED AND ADJUDGED that

defendants and their officers, agents, servants, employees,

or successors and attorneys and those in active concert or

participation with them are hereby permanently enjoined

and restrained from enforcing or applying 9 C.F.R.

: 317.17 (b) and (c) and § 319.2, 44 Fed. Reg. 48961 (Au-

gust 21, 1979).

Dated at Des Moines, lowa, this 12th day of February,

1980.

/s/ James R. Rosenbaum

Clerk of Court

App. 22

IN THE UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF IOWA

CENTRAL DIVISION

NATIONAL PORK PRODUCERS COUNCIL, et al.,

Plaintiffs,

and

NATIONAL INDEPENDENT MEAT PACKERS

ASSOCIATION,

Plaintiff-Intervenor.

vs.

BOB §. BERGLAND, et al.,

Defendants.

Civil No. 79-431-C

RULING AND ORDER

This is an action for judicial review of agency action

pursuant to the Administrative Procedure Act (APA), 5

U.S.C. §§ 551, et seq. Plaintiffs are three members of the

United States House of Representatives and two trade

associations representing pork producers and meat pack-

ers. Defendants are the Secretary of Agriculture, the As-

sistant Secretary of Agriculture for Food and Consumer

Services, and the Acting Administrator of the Food Safety

and Quality Service (FSQS) of the United States Depart-

ment of Agriculture (USDA). Plaintiffs seek a declara-

tory judgment that a USDA regulation permitting meat

products prepared without nitrates or nitrites to be mar.

keted under traditional names, such as bacon, ham, corned

beef, and frankfurters, is arbitrary, capricious, an abuse

of discretion and not otherwise in accordance with law.

App. 23

They also request permanent injunctive relief preventing

defendants from approving meat product labels under the

challenged provision.

On April 28, 1978, the Administrator of FSQS proposed

to amend the federal meat inspection regulations (See

Federal Meat Inspection Act of 1907, 21 U.S.C. §§ 601 et

seq.) to permit the preparation and sale of meat food prod-

ucts under those traditional names, even though such prod-

ucts, which have traditionally been cured with nitrates or

nitrites, would be prepared without such preservatives. 43

Fed. Reg. 18193 (April 28, 1978). He further proposed

that:

(1) <A product not prepared with nitrates or ni-

trites should be labeled ‘No Nitrate or Nitrite Added

—Not Preserved, Must Be Refrigerated Below 40° F.

at All Times’; and

(2) The preparation and sale of a product pre-

pared without nitrate or nitrite should be permitted

only if the product is prepared with some added sub-

stance or substances and is found by the Administra-

tor to have a similar flavor and consistency to the

product prepared with nitrate or nitrite.

Id. at 18194-95. Individual consumers, consumer organiza-

tions, trade associations and others submitted 365 com-

ments to FSQS regarding the proposed amendments.

FSQS reviewed the comments and on July 18, 1979, con-

sulted the National Advisory Committee on Meat and

Poultry Inspection (the Advisory Committee) with regard

to the proposals and the comments thereon. On August 21,

1979, the Acting Administrator of FSQS (who is herein-

after referred to as the ‘‘Administrator’’), promulgated a

regulation permitting, inter alia, meat products prepared

without nitrates or nitrites io be marketed under the tradi-

tional names of products prepared with nitrates or nitrites

if :

% a A IRA aaa eam

App. 24

(1) The traditional name on the label of the prod-

uct prepared without nitrates or nitrites is preceded

by the word ‘Uncured’ in the same size and style of

lettering as the traditional name;

(2) The label carries the following information

adjacent to the product name in lettering of easily

readable style and at least one-half the size of the

product name:

(a) ‘No Nitrate or Nitrite Added’; and

(b) ‘Not Preserved—Keep Refrigerated Below

40°F, At All Times’;

(3) The product is found by the Administrator to

be similar in size, flavor, consistency and general ap-

pearance to the product commonly prepared with ni-

trate or nitrite.

44 Fed. Reg. 48959-961 (August 21, 1979).

On September 20, 1979, the National Pork Producers

Council and Congressmen Grassley, Hagedorn and Symms

filed this action. The National Independent Meat Packers

Association was subsequently permitted to intervene as a

party plaintiff. On November 9, 1979, plaintiffs’ motion

for a preliminary injunction came on for hearing before

the Court. Subject to defendants’ evidentiary objection

noted infra and plaintiffs’ request to present a consumer

perception survey as evidence at a later date, it was

agreed that the hearing would also constitute trial on the

merits of plaintiffs’ claims for a declaratory judgment

and permanent injunction. See Fed. R. Civ. P. 65(a) (2).

The Court did not rule on plaintiffs’ request and would

treat such application as a motion to reopen for newly

discovered evidence. On November 14, 1979, the Court

granted plaintiffs’ motion for a preliminary injunction.

Defendants have appealed therefrom, but the Court will

file its ruling on the merits in order to provide defendants

an opportunity to present the entire matter at one time.

App. 25

Plaintiffs claim the regulation is ‘‘arbitrary, capricious,

an abuse of discretion, or otherwise not in accordance with

law’’, 5 U.S.C. § 706 (2)(A), on the following grounds,

inter alia:

(1) Defendants failed to consider all relevant factors,

including the danger that botulism, a deadly food poison-

ing, would develop in uncured products that are not prop-

erly refrigerated as well as the adequacy of the labeling

requirements to prevent mishandling;

(2) The regulation was promulgated for the unlawful

purpose of promoting a market for uncured products;

(3) The regulation’s similarity requirement is an im-

permissably subjective standard of identity that

(a) bears no rational relationship to the purposes

of standards of identity;

(b) was beyond defendants’ authority to promul-

gate; and

from previous standards of identity;

(4) The regulation requires uncured products to re-

semble cured products but does not require uncured prod-

ucts to be labeled as ‘‘imitation’’; and

(5) Defendants did not prepare or consider preparing

an Environmental Impact Statement (EIS).

Defendants contend that the Administrator acted reason-

ably and for a lawful purpose; that the similarity require-

ment is proper in all respects; and that neither the label

‘imitation’? nor an EIS is required.

Defendants also insist that the Court’s review of plain-

tiffs’ claims on the merits is limited to the administrative

App. 26

record.’ Defendants rely upon Federal Power Comm’n.

v. Trancontinental Pipe Line Corp., 423 U.S. 326, 331

(1976) ; Independent Meat Packers Ass’n v. Butz, 526 F.

2d 228, 239 (8th Cir. 1975), cert denied, 424 U.S. 966

(1976); Nickol v. United States, 501 F. 2d 1389 (10th

Cir. 1974); and Wilson & Co. v. United States, 335 F. 2d

788, 799 (7th Cir. 1964), cert denied, 380 U.S. 951 (1965).

Plaintiffs cite Hiatt Grain & Feed, Inc. v. Bergland, 446

F. Supp. 457, 467 (D. Kan. 1978), aff’d on other grounds,

602 F. 2d 929 (8th Cir. 1979), for the proposition that

evidence outside the administrative record is admissible

in order to assist the Court in understanding the technical,

scientific and consumer perception issues presented; to

assist the Court in determining whether an EIS should

have been prepared; and to establish whether defendants

have overlooked any relevant factors in promulgating the

rule.

In a recent action for judicial review under 5 U.S.C.

§ 706(2)(A), the Eighth Cireuit has held, on the basis

of an extensive quotation from Citizens to Preserve Over.

ton Park, Inc. v. Volpe, 401 U.S. 402, 420-21 (1971), that:

[U]nless an inadequate evidentiary development be-

fore the agency can be shown and supplemental in-.

formation submitted by the agency does not provide an

acequate basis for judicial review, the court in con-

ducting the plenary review mandated by Overton Park

should limit its inquiry to the administrative record

already in existence supplemented, if necessary, by

affidavits, depositions, or other proof of an explanatory

nature.

‘In this case the administrative record consists of the proposed

rulemaking, the Final Impact Statement (FIS) prepared June 14,

1979 by FSQS, the transcript of FSQS’s consultation with the Ad-

visory Committee, and the final rule and other information published

August 21, 1979.

App. 27

Independent Meat Packers Ass’n v. Butz, supra, at 239.

In the instant case, the Court admitted evidence in support

of an in opposition to plaintiffs’ motion for a preliminary

injunction. Its introduction for that limited purpose was

not objected to. The Court admitted this same evidence on

the merits of plaintiffs’ claims for declaratory and perma-

nent injunctive relief in order to permit the parties to

make as complete a record as possible. In accordance

with the principles set forth in Independent Meat Packers

and Overton Park, supra, the Court has considered only

the administrative record, supplemented by such explana-

tory evidence as is specifically noted hereinafter, in this

ruling upon the merits of plaintiffs’ claims. The evidence

offered by the parties has not been considered for any other

purpose.

SCOPE OF REVIEW

Under 5 U.S.C. § 706(2)(A), the Court is required to

make a ‘‘thorough, probing, in-depth review’’ of the de-

fendants’ action. Overton Park, supra, at 415. If that

scrutiny discloses that the defendants acted outside the

scope of their authority, Schilling v. Rogers, 363 U.S. 666,

676-77 (1960); failed to consider ‘‘all relevant facts’’,

Sabin v. Butz, 515 F. 2d 1061, 1069 (10th Cir. 1975) ; United

States v. Nova Scotia Food Products Corp., 568 F. 2d 240,

251 (2nd Cir. 1977) ; failed to develop an adequate adminis-

trative record which supports necessary findings, WAIT

Radio v. Federal Communications Comm’n, 418 F. 2d 1153,

1156 (D.C. Cir. 1969), cert. denied, 409 U.S. 1027 (1972) ;

or failed to reach conclusions that are rationally supported

by those findings, Burlington Truck Lines, Inc. v. United

States, 371 U.S. 156, 168 (1962); the administrative action

will be deemed to be arbitrary, capricious, an abuse of

discretion, and not in accordane with law and will be set

aside. Hence, agency action will not be sustained if ‘‘in-

App. 28

adequacy of explanation frustrates review’’. National

Nutritional Foods Ass’n v. Weinberger, 512 F. 2d 688, 701

(2nd Cir.), cert. denied, 423 U.S. 827 (1975). See also

United States v. Nova Scotia Food Products Corp., supra;

Environmental Defense Fund, Ine. v. Ruckelhaus, 439 F.

2d 584 (D.C. Cir. 1971).

Plaintiffs claim that since products preserved without

nitrate or nitrite will have the name, appearance, taste and

consistency of products preserved with nitrate or nitrite,

consumers will be included to handle the unpreserved

product in the way preserved products have been handled

and thereby expose themselves to a greater risk of botu-

lism. They contend that the labeling requirements will not

alert the consumers of the unpreserved products of the

danger to their health if those products are not properly

refrigerated. Plaintiffs claim defendants acted arbitrarily

and capriciously in issuing ‘‘a regulation which permits

nitrite-free products to be sold under the disguise and

name of nitrite-cured products such that consumers, un-

warned of the switch, will handle the new product un-

safely’’. In this connection, plaintiffs claim that defen-

dants failed to consider (1) the potential for botulism if

uncured products are treated in the same manner cured

products have been treated, and (2) whether the required

labeling will sufficiently alert the consumer to the differ-

ences in the safe handling characteristics of the two types

of products.

Defendants claim that USDA considered all relevant

factors, applied its experience and expertise, and made a

reasonable judgment as to consumer behavior which should

not be overturned by this Court. They contend that the

labels are not misleading and that the Administrator had

App. 29

a rational basis for his conclusion that the labels would

adequately inform consumers of the nature and handling

requirements of the unpreserved products.

Plaintiffs evidence at trial was primarily directed toward

(1) whether consumers would read, understand and believe

the labels on the unpreserved products, and (2) the likeli-

hood that botulism would develop in unpreserved products

not refrigerated in accordance with the instructions on the

labels. The Court’s task here is not to decide these issues

but to determine whether defendants adequately considered

them.

Upon the basis of the administrative record, the Court

finds the regulation invalid for the reasons, inter alia, that

there is no rational basis in the administrative record for

the Administrator’s conclusion that the information on the

labels of the uncured products is adequate to prevent con-

sumers from confusing the uncured products with the cured

products, and defendants failed to consider the relevant

factor of whether consumers handle cured products in a

manner such that botulism would develop in uncured prod-

ucts handled in the same manner.

In the notice of the proposed rule, the Administrator

recognized that meat products prepared without nitrates or

nitrites ‘‘may better support the growth and toxin produc-

tion of Clostridium botulinum |than] meat products pre-

pared with the traditional levels of nitrate and/or nitrite

currently permitted by regulation’’ and that ‘‘Clostridium

botulinum intoxeation (botulism) is a type of food poison-

ing which often causes death.’’ 43 Fed. Reg. 18193 (April

28, 1978). He concluded, and plaintiffs agree, that meat

products prepared without nitrate or nitrite should be

refrigerated at or velow 40°F. at all times in order to be

protected from botulism. /d. at 18194. The Administrator

App. 30

also recognized the potential confusion among consumers

between traditionally cured products and the products to

be marketed under the proposed rule. He proposed the

special labeling requirements for products prepared with-

out nitrate or nitrite, ‘‘since meat products prepared with

no nitrate or nitrite . . . could be confused with products

containing the traditional levels of nitrate and/or nitrite.”’

Id.

Numerous comments regarding the proposed rule sug-

gested that consumers have developed established handling

practices and uses for traditionally cured products where-

by such products are not always refrigerated below 40°F,

prior to preparation for consumption; that consumers

would not read, understand or believe the proposed labels

for the unpreserved products; that consumers would be

confused or deceived by the similarity of the uncured prod-

ucts to the cured products; that consumers would handle

the uncured products in the same fashion as cured prod-

ucts; and that botulism would develop in the uncured prod-

ucts as a result. See, e.g., Comments 253, 258, 260, and

280. Members of the Advisory Committee and defendant

Foreman’s own assistant expressed much the same con-

cerns. See the Transcript of July 18, 1979, Consultation

with the Advisory Committee, pages 70, 71, 76.

The Administrator noted that there was an issue as to

whether cured products had been handled in a manner

such that botulism would develop in uncured products

handled in the same manner. Jd. at 69-70. In the preamble

to the final rule, he recognized the potential for confusion

if cured and uncured products were marketed under the

same name and the question whether the proposed labeling

provisions would be adequate to protect against botulism

in the unpreserved products. 44 Fed. Reg. 48959 (August

21, 1979). He concluded that the information on the final

App. 31

label, with the addition of the term ‘‘uncured’’, would

prevent botulism by informing consumers of the difference

between the two types of products and the need to refrig-

erate the uncured products. Based on his awareness ‘‘that

products requiring ... special handling such as _ pork

sausage, bratwurst and brockwurst have presented no

apparent health hazards even though prepared without

nitrates or nitrites and marketed unfrozen’’, Jd. at 48960,

he concluded

that consumers have demonstrated a knowledge of the

handling practices necessary for any of such products

prepared without nitrates or nitrites and that the

prescribed labeling for such products, i.e., ‘Not Pre-

served-Keep Refrigerated Below 40°F. At all Times’,

will adequately inform the consumer of how to main-

tain such products in a wholesome condition until con-

sumed.

Id. ‘‘In addition [to this information, he] determined,

based on the comments, that the use of nitrates and nitrites

is of such importance in products preserved by these sub-

stances, that products prepared without such substances

should have different names from those prepared with

nitrates or nitrites in order to more clearly distinguish

such produets.’’ Jd. at 48959. He concluded that the term

‘*Uneured’’ would sufficiently distinguish such products

because ‘‘{t]|he term ‘Uncured’ in the labeling of a meat

food product is commonly understood to mean that the

product does not contain nitrates or nitrites, and that the

product was not preserved with salt.’’ Td.

The Administrator determined that the uncured prod-

ucts should be refrigerated below 40°F. in order to pre-

vent the development of botulism. The comments sug-

gested and defendants admit that traditionally cured prod-

ucts have not always been so handled. The Administrator

App. 32

did not make any determination regarding the risk that

botulism might develop in uncured products handled in

the same manner cured products have been handled.

Rather, he concluded that the uncured products would not

be handled as cured products because the labels on the

uncured products would distinguish them from the cured

products and inform the consumer how to handle them

properly. This conclusion was based upon his determina-

tion that the term ‘‘uncured*’ is commonly understood to

mean ‘‘prepared without nitrates or nitrites’’ and his

awareness that the marketing of other uncured products,

such as pork sausage, bratwurst and brockwurst, has pre-

sented no health problem.

The term ‘‘uncured’’ is apparently understood by some

to mean that a product is prepared without nitrates or

nitrites. See Comments 83, 92, 122, 156, 157, 182, 192, and

238. The impetus for the rule change came from the

producers of non-nitrite or nitrate preserved products and

consumers who were concerned with the possible carcino-

gens in foods preserved by them. Similar non-nitrite prod-

ucts are available, but consumers claimed they have had

difficulty locating them in the stores since they did not

carry the traditional names. Many comments about the

proposed rule change came from such consumers. ‘To con-

clude, on the basis of the comments of persons interested

in the controversy, that the 200 million consumers in this

country generally share defendants’ definition is irrational.

Furthermore, unlike previously marketed uncured prod-

ucts, the uncured products permitted by defendants’ regu-

lation will be similar in size, appearance, taste and con-

sistency to cured products. There is no rational basis in

the administrative record for the conclusion that ordinary

consumers, faced with a long-established product and a

new product that differs only in the information on its

label, will distinguish between the two products.

App. 33

The Court agrees with defendants’ argument that a fair

respect for a statute that is primarily a regulation of

labels requires rejection of an attack predicated on the

notion that consumers are incapable of following instruc-

tions because of total illiteracy or universal disregard of

instructions. See Stearns Electric Paste Co. v. Environ-

mental Protection Agency, 461 F. 2d 293, 310 (7th Cir.

1972). See also Southern National Mfg. Co. v. Environ-

mental Protection Agency, 470 F. 2d 194, 200 (8th Cir.

1972). However, it has long been recognized that few

consumers read all of the information on labels and many

cannot read labels at all. Houston v. St. Louis Indepen-

dent Pkg. Co., 249 U.S. 479, 487 (1919). See also Federa-

tion of Homemakers v. Butz, 466 F’. 2d 462, 466 (D.C. Cir.

1972). Indeed, the Secretary of Agriculture himself has

argued that consumers do not read everything on a label

and that even those who do might not understand all of

the information thereon. Armour and Co. v. Freeman, 304

F’, 2d 404, 413 (D.C. Cir.), cert. denied, 370 U.S. 920 (1962)

(Prettyman, J., concurring). Recognition of these facts

is not ‘‘a blow at the whole theory of labeling’’, as some

might hold. See Id. Rather, it is an acknowledgment of

‘*the inability of consumers in some cases to determine,

solely on the basis of informative labeling, the relative

merits of a variety of products superficially resembling

each other.’’ Federal Security Administrator v. Quaker

Oats Co., 318 U.S. 218, 230-31 (1943) (Footnote omitted).

The testimony of Mr. Fried, Acting Director of Prod-

ucts Standards and Labels, was not particularly helpful to

defendants. He had no background to testify as an expert

on consumer habits in reading labels or caring for nitrite

preserved products. His primary reason for believing con-

sumers would be protected was based on his experience

that consumers put products displayed on shelves in the

pantry and place products displayed in refrigerated cases

App. 34

in the refrigerator. This is « pragmatic observation that

is probably accurate, but it does not aid the defendants

here because the nitrite preserved products are also sold

from refrigerated cases. The Court feels strongly that

the defendants failed to give adequate consideration to

the dangers of botulism and to consumer conduct in read-

ing labels and caring for nitrite products.

Although the Court would have felt more comfortable in

reviewing the defendants’ agency action if the public

health arguments had been advanced by parties with a less

direct economic interest in the outcome of this lawsuit,

the Court is persuaded that the fears are genuine and that

the USDA failed to give adequate attention to the dangers

of botulism, the manner in which the public cares for

nitrite preserved products and the effectiveness of label-

ing. The Court believes the USDA acted arbitrarily and

capriciously in promulgating the questioned rule and in

establishing the labeling standards.

II.

Plaintiffs claim that the regulation was promulgated for

the unlawful purpose of promoting or encouraging a mar-

ket for uncured products, thus favoring one class of pro-

ducers over another. The FIS prepared June 14, 1979

states that the purpose of the final rule

is to allow the use of familiar names for the tradi-

tional, but nitrite-free processed meat products. Al-

lowing these products to be marketed by traditional

names will increase consumer awareness of their avail-

ability as well as consumption by those wishing to fore-

go consumption of nitrite cured products.

The FIS also states that defendants considered the alter-

native of taking no action with regard to uncured products

but rejected that option ‘‘because it does not facilitate the

App. 35

development of markets for nitrate and/or nitrite-free

products’’.

Defendants do not claim that the purpose ascribed to

the regulation by plaintiffs is a proper one. They deny

that plain.iffs’ statement of the purpose of the regulation

is correct and claim that the regulation is designed to make

available to consumers, who wish them, products that are

similar to traditional products yet free of nitrates and

nitrites, which are suspected but unproven carcinogens.

Defendants claim that in adopting the final rule, the Ad-

ministrator simply allowed the market to grow in response

to consumer demand. The administrative record does not

support this contention. Almost 170 uncured products

were available on the market under their own names at the

time the rule was adopted. To permit the use of the

traditional names and to require similarity between cured

and uncured products were not necessary to make the

products available to those who wanted them. Therefore

neither the use of the traditional names nor the similarity

requirements bear a rational relationship to the claimed

purpose of availability. As indicated earlier, those who

wished to enjoy similar products without nitrate or

nitrites instigated the rule change for their own conven-

ience.

Defendants claim that ‘‘the final rule represents the

effort of defendants to offer consumers the opportunity

of obtaining pork products under their traditional names,

. . . but without ingredients which many believe to be

carcinogenic’? and that they ‘‘acted reasonably .. . in

balancing the public health . . . interests involved in this

ease.’’ They imply that the purpose of the rule is to pro-

mote the public health by reducing the incidence of cancer

in Americans. However, section 4(b) of the APA, 5 U.S.C.

$ 553(c), states that ‘‘the agency shall incorporate in the

App. 36

rules adopted a concise general statement of their basis

and purpose.’’ Neither the proposed rule, the FIS, nor

the final rule give any indication that such is the purpose

of the final rule. Nor has research progressed to the point

that the defendants could justifiably claim such purpose.

Regardless of the alleged purpose, the nature and text of

the questioned regulations clearly has the effect of in-

creasing the marketability of uncured products. The Court

can only conclude that approval of the use of traditional

names and the similarity requirement in the final rule was

given by the Administrator for the purpose of facilitating

markets for uncured products, and thereby increasing the

consumption of those products, at the expense of producers

of cured products. Such purpose is not proper. This is

not to say that, under proper labeling, uncured products

that are similar to nitrite preserved products, are not wel-

come additions to the market place. However, it is not

claimed and it cannot be held that the Federal Meat In-

spection Act of 1907 (the Meat Act) allows the Adminis-

trator to take it upon himself to actively promote the

marketing of a meat product. See 21 U.S.C. §§ 602, 607(c).