Supreme Beef Processors, Inc. v. United States Department of Agriculture

REVISED DECEMBER 17, 2001
IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 00-11008

SUPREME BEEF PROCESSORS, INC,
Plaintiff-Appellee,

versus

UNITED STATES DEPARTMENT OF AGRICULTURE,
Defendant-Appellant.

Appeal from the United States District Court
For the Northern District of Texas

December 6, 2001

Before REAVLEY, HIGGINBOTHAM, and PARKER, Circuit Judges.

PATRICK E. HIGGINBOTHAM, Circuit Judge:

Certain meat inspection regulations promulgated by the

Secretary of Agriculture, which deal with the levels of Salmonella

in raw meat product, were challenged as beyond the statutory

authority granted to the Secretary by the Federal Meat Inspection

Act. The district court struck down the regulations. We hold that

the regulations fall outside of the statutory grant of rulemaking

authority and affirm.
 I

The Federal Meat Inspection Act authorizes the Secretary of

Agriculture to “prescribe the rules and regulations of sanitation”

covering

slaughtering, meat canning, salting, packing, rendering,
or similar establishments in which cattle, sheep, swine,
goats, horses, mules and other equines are slaughtered
and the meat and meat food products thereof are prepared
for commerce....1

Further, the Secretary is commanded to,

where the sanitary conditions of any such establishment
are such that the meat or meat food products are rendered
adulterated, ... refuse to allow said meat or meat food
products to be labeled, marked, stamped, or tagged as
“inspected and passed.”2

In sum, the FMIA instructs the Secretary to ensure that no

adulterated meat products pass USDA inspection, which they must in

order to be legally sold to consumers.3

The FMIA contains several definitions of “adulterated,”

including 21 U.S.C. § 601(m)(4), which classifies a meat product as

adulterated if “it has been prepared, packed, or held under

insanitary conditions whereby it may have become contaminated with

filth, or whereby it may have been rendered injurious to health.”4

Thus, the FMIA gives the Secretary the power to create sanitation

1
21 U.S.C. § 608.
2
Id.
3
The FMIA requires that adulterated meat products be stamped “inspected
and condemned” and destroyed. 21 U.S.C. § 606.
4
Id. § 601(m)(4).

2
regulations and commands him to withhold meat approval where the

meat is processed under insanitary conditions. The Secretary has

delegated the authority under the FMIA to the Food Safety and

Inspection Service.

In 1996, FSIS, after informal notice and comment rulemaking,

adopted regulations requiring all meat and poultry establishments

to adopt preventative controls to assure product safety. These are

known as Pathogen Reduction, Hazard Analysis and Critical Control

Point Systems or “HACCP.”5 HACCP requires, inter alia, that meat

and poultry establishments institute a hazard control plan for

reducing and controlling harmful bacteria on raw meat and poultry

products. In order to enforce HACCP, FSIS performs tests for the

presence of Salmonella in a plant’s finished meat products.

The Salmonella performance standards set out a regime under

which inspection services will be denied to an establishment if it

fails to meet the standard on three consecutive series of tests.6

The regulations declare that the third failure of the performance

standard “constitutes failure to maintain sanitary conditions and

failure to maintain an adequate HACCP plan ... for that product,

and will cause FSIS to suspend inspection services.”7 The

performance standard, or "passing mark," is determined based on

5
9 C.F.R. Pt. 417.
6
Id. § 310.25(b).
7
Id. § 310.25(b)(3)(iii).

3
FSIS’s “calculation of the national prevalence of Salmonella on the

indicated raw product.”8

In June, 1998, plaintiff-appellee Supreme Beef Processors,

Inc., a meat processor and grinder, implemented an HACCP pathogen

control plan, and on November 2, 1998, FSIS began its evaluation of

that plan by testing Supreme's finished product for Salmonella.

After four weeks of testing, FSIS notified Supreme that it would

likely fail the Salmonella tests. Pursuant to the final test

results, which found 47 percent of the samples taken from Supreme

contaminated with Salmonella,9 FSIS issued a Noncompliance Report,

advising Supreme that it had not met the performance standard.

Included in the report was FSIS's warning to Supreme to take

"immediate action to meet the performance standards." Supreme

responded to FSIS's directive on March 5, 1999, summarizing the

measures it had taken to meet the performance standard and

requesting that the second round of testing be postponed until mid-

April to afford the company sufficient time to evaluate its

laboratory data. FSIS agreed to the request and began its second

round of tests on April 12, 1999.

On June 2, 1999, FSIS again informed Supreme that it would

likely fail the Salmonella tests and, on July 20, issued another

Noncompliance Report—this time informing Supreme that 20.8 percent

8
Id. § 310.25(b)(2) tbl. 2 n.a.
9
The performance standard for raw ground beef is 7.5 percent. Id.

4
of its samples had tested positive for Salmonella. Supreme

appealed the Noncompliance Report, citing differences between the

results obtained by FSIS and Supreme's own tests conducted on

"companion parallel samples." Those private tests, Supreme

asserted, had produced only a 7.5 percent Salmonella infection

level, satisfying the performance standard. FSIS denied the

appeal; but based on Supreme's commitment to install 180 degree

water source on all boning and trimming lines, granted the

company's request to postpone the next round of Salmonella testing

for 60 days. FSIS later withdrew the extension, however, after

learning that Supreme was merely considering installation of the

water source.

The third set of tests began on August 27, 1999, and after

only five weeks, FSIS advised Supreme that it would again fall

short of the ground beef performance standard. On October 19,

1999, FSIS issued a Notice of Intended Enforcement Action, which

notified Supreme of the agency's intention to suspend inspection

activities. The Notice gave Supreme Beef until October 25, 1999 to

demonstrate that its HACCP pathogen controls were adequate or to

show that it had achieved regulatory compliance. Although Supreme

Beef promised to achieve the 7.5 percent performance standard in

180 days, it failed to provide any specific information explaining

how it would accomplish that goal, and FSIS decided to suspend

inspection of Supreme's plant.

5
 On the day FSIS planned to withdraw its inspectors, Supreme

brought this suit against FSIS's parent agency, the USDA, alleging

that in creating the Salmonella tests, FSIS had overstepped the

authority given to it by the FMIA. Along with its complaint,

Supreme moved to temporarily restrain the USDA from withdrawing its

inspectors. The district court granted Supreme's motion and, after

a subsequent hearing, also granted Supreme's motion for a

preliminary injunction.

The National Meat Association filed a motion to intervene as

a plaintiff in the district court. The district court denied the

motion on the grounds that NMA was adequately represented by

Supreme in this litigation. The district court allowed NMA and

other industry groups, as well as various consumer advocacy groups,

to file briefs.

On cross-motions for summary judgment, the district court

granted summary judgment in favor of Supreme, finding that the

Salmonella performance standard exceeded the USDA’s statutory

authority and entering a permanent injunction against enforcement

of that standard against Supreme. The USDA now appeals.

II

We first must address the USDA's suggestion of mootness. In

September, 2000, during the pendency of this appeal, Supreme filed

for Chapter 11 bankruptcy. The USDA moved to lift the stay on the

6
appeal and filed a suggestion of mootness with this Court. Supreme

argued that it intended to resume operations after reorganization

and that the injunction against enforcement of the Salmonella

performance standard was critical to that reorganization. A

motions panel of this Court denied the motion to remand the case

with instructions to dismiss as moot on January 2, 2000. On May 9,

2001, the Bankruptcy Court converted Supreme's case into a Chapter

7 liquidation.

The USDA has again raised the question of mootness. While we

are not bound by the earlier determination of the motions panel,

which in any event was made while Supreme was still in Chapter 11,

rather than Chapter 7, proceedings,10 Supreme asserts that it has

substantial assets and could emerge solvent from the Chapter 7

liquidation proceeding. "In general a matter is moot for Article

III purposes if the issues presented are no longer live or the

parties lack a legally cognizable interest in the outcome."11 The

possibility that Supreme may continue to function as a meat

processor even after its Chapter 7 proceeding satisfies Article

III.12

10
AT&T Communications of the Southwest, Inc. v. City of Dallas, 243 F.3d
928, 930 (5th Cir. 2001) (stating that although a motions panel had denied a
motion to vacate as moot, court could consider arguments on appeal and "overturn
[the motions panel] where necessary." (quoting Mattern v. Eastman Kodak, Co., 104
F.3d 702, 704 (5th Cir. 1997))).
11
Sierra Club v. Glickman, 156 F.3d 606, 619 (5th Cir. 1998).
12
Since we find that Article III is satisfied by Supreme’s continuing
legally cognizable interest in the outcome, we need not address its argument that
this case falls into that category of disputes capable of repetition yet evading

7
 The USDA argues that this case is moot because even if Supreme

reopens “it is conceivable that it will not open at the same

establishment where the violations of the Salmonella standard

occurred and will not use the same suppliers.” However, the

district court's order is not specific to Supreme’s place of

business nor its suppliers. The Amended Final Judgment provides in

part:

1. 9 C.F.R. 310.25(b) is hereby declared to be outside
the statutory authority of the United States Secretary of
Agriculture (the “Secretary”) and the United States
Department of Agriculture (the “USDA”)....

This injunction issued because the district court determined that

the USDA was without statutory authority to promulgate the

Salmonella performance standards—it cannot be logically restricted

to a particular facility.

Furthermore, NMA, having submitted a brief as an amicus curiae

supporter of Supreme, again moved to intervene as an appellee,

arguing that were we to find that the case was moot with respect to

Supreme, NMA's interests were no longer adequately represented by

Supreme and this inadequacy only arose during the pendency of the

appeal.

We granted NMA's motion to intervene. “A party is entitled

to an intervention of right if (1) the motion to intervene is

timely; (2) the potential intervener asserts an interest that is

review.

8
related to the property or transaction that forms the basis of the

controversy in the case into which [it] seeks to intervene; (3) the

disposition of that case may impair or impede the potential

intervener’s ability to protect [its] interest; and (4) the

existing parties do not adequately represent the potential

intervener’s interest.”13 The district court denied NMA’s motion

to intervene because it found that NMA’s interests were adequately

represented by Supreme. In all other respects, NMA satisfies the

requirements of intervention as of right under Rule 24(a),14 and we

address only adequacy of representation here.

We recognize that while Supreme retains a legally cognizable

interest in the outcome of this case, this is because of the

possibility that Supreme will emerge from bankruptcy as an entity

wishing to carry out meat processing operations. It is also

possible, we understand, that Supreme will not so emerge from

bankruptcy and be dissolved, perhaps during the pendency of any

petition for panel rehearing, rehearing en banc, or writ of

certiorari before the U.S. Supreme Court. NMA need only show that

13
John Doe No. 1. v. Glickman, 256 F.3d 371, 375 (5th Cir. 2001).
14
Fed. R. Civ. P. 24(a). There can be no serious dispute that NMA’s
original motion to intervene was timely and that NMA has an interest in this
lawsuit, given that it deals with the application of a performance standard that
affects NMA’s members. NMA has standing to pursue this appeal. “An association
has standing to bring a suit on behalf of its members when: (1) its members would
otherwise have standing to sue in their own right; (2) the interests it seeks to
protect are germane to the organization’s purpose; and (3) neither the claim
asserted nor the relief requested requires the participation of individual
members.” Central and South West Services, Inc v. EPA, 220 F.3d 683, 698 (5th
Cir. 2000).

9
Supreme’s representation “may be” inadequate,15 and we find the

possibility that the case could be mooted by decisions made in

Supreme’s Chapter 7 proceeding sufficient to satisfy this

requirement of Rule 24(a). Were Supreme to cease to exist as a

legal entity, or were the case to otherwise become moot with

respect to Supreme, NMA would be put in the position of having to

re-litigate identical issues on which Supreme was successful in the

district court. The interest in avoiding piecemeal litigation is

thus served by allowing NMA’s intervention.16

Having concluded that this case is not moot, we now turn to

the question of whether the Salmonella performance standard

represents a valid exercise of rulemaking authority under the FMIA.

III

Our analysis in this case is governed by the approach first

enunciated by the Supreme Court in Chevron U.S.A., Inc. v. Natural

Resources Defense Council, Inc.17 The Chevron inquiry proceeds in

two steps. First, the court should look to the plain language of

the statute and determine whether the agency construction conflicts

15
Sierra Club v. Espy, 18 F.3d 1202, 1207 (5th Cir. 1994).
16
See, e.g., Goodman v. Heublein, 682 F.2d 44, 47 (2d. Cir. 1987)
(granting motion to intervene in part to avoid piecemeal litigation).
17
467 U.S. 837 (1984).

10
with the text.18 Then, “[i]f the agency interpretation is not in

conflict with the plain language of the statute, deference is

due.”19 The district court held the Salmonella performance standard

invalid as exceeding the statutory authority of the USDA under the

first step of the Chevron inquiry.

A

Following Chevron, we first repair to the text of the statute

that the USDA relies upon for its authority to impose the

Salmonella performance standard. The USDA directs us to 21 U.S.C.

§ 601(m)(4), which provides that a meat product is adulterated

if it has been prepared, packed or held under insanitary
conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to
health.

This statutory definition is broader than that provided in 21

U.S.C. § 601(m)(1), which provides that a meat product is

adulterated

if it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in
case the substance is not an added substance, such
article shall not be considered adulterated under this
clause if the quantity of such substance in or on such
article does not ordinarily render it injurious to
health.

18
Nat’l R.R. Passenger Corp. v. Boston & Maine Corp., 503 U.S. 407, 417
(1992).
19
Id.

11
Thus if a meat product is “prepared, packed or held under

insanitary conditions” such that it may be adulterated for purposes

of § 601(m)(1), then it is, by definition, adulterated for purposes

of § 601(m)(4). The USDA is then commanded to refuse to stamp the

meat products “inspected and passed.”20

The difficulty in this case arises, in part, because

Salmonella, present in a substantial proportion of meat and poultry

products, is not an adulterant per se,21 meaning its presence does

not require the USDA to refuse to stamp such meat “inspected and

passed.”22 This is because normal cooking practices for meat and

poultry destroy the Salmonella organism,23 and therefore the

presence of Salmonella in meat products does not render them

“injurious to health”24 for purposes of § 601(m)(1). Salmonella-

infected beef is thus routinely labeled “inspected and passed” by

USDA inspectors and is legal to sell to the consumer.

20
21 U.S.C. § 608.
21
See American Pub. Health Ass’n v. Butz, 511 F.2d 331, 334 (D.C. Cir.
1974) (“[T]he presence of salmonellae on meat does not constitute adulteration
within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601(m)].”).
The USDA agrees in this case that Salmonella is not an adulterant per se, meaning
it is not a § 601(m)(1) adulterant. Appellant’s Brief at 11.
22
21 U.S.C. § 608.
23
Butz, 511 F.2d at 334 (“American housewives and cooks normally are not
ignorant or stupid and their methods of preparing and cooking of food do not
ordinarily result in salmonellosis.”).
24
Cf. Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 41 (D.C. Cir.
1982) (stating that Salmonella is a per se adulterant in shrimp).

12
 Supreme maintains that since Salmonella-infected meat is not

adulterated under § 601(m)(1), the presence or absence of

Salmonella in a plant cannot, by definition, be “insanitary

conditions” such that the product “may have been rendered injurious

to health,” as required by § 601(m)(4). The USDA, however, argues

that Salmonella’s status as a non-adulterant is not relevant to its

power to regulate Salmonella levels in end product. This is

because the USDA believes that Salmonella levels can be a proxy for

the presence or absence of means of pathogen25 controls that are

required for sanitary conditions under § 601(m)(4). However, as we

discuss, and as the USDA admits, the Salmonella performance

standard, whether or not it acts as a proxy, regulates more than

just the presence of pathogen controls.

The district court agreed with Supreme and reasoned that

“[b]ecause the USDA’s performance standards and Salmonella tests do

not necessarily evaluate the conditions of a meat processor’s

establishment, they cannot serve as the basis for finding a plant’s

meat adulterated under § 601(m)(4).”26 The district court therefore

held that the examination of a plant’s end product is distinct from

25
The USDA uses the term “pathogen” to refer to both § 601(m)(1)
adulterants, such as pathogenic E.coli, and non-adulterants, such as Salmonella.
Thus, under the proxy theory, Salmonella control correlates with adulterant-
pathogen control.

26
Supreme Beef Processors, Inc. v. USDA, 113 F. Supp.2d 1048, 1052-53
(N.D. Tex. 2000) (emphasis in original).

13
“conditions” within the plant for purposes of § 601(m)(4) because

Salmonella may have come in with the raw material.

We must decide two issues in order to determine whether the

Salmonella performance standard is authorized rulemaking under the

FMIA: a) whether the statute allows the USDA to regulate

characteristics of raw materials that are “prepared, packed or

held” at the plant, such as Salmonella infection; and b) whether §

601(m)(4)’s “insanitary conditions” such that product “may have

been rendered injurious to health” includes the presence of

Salmonella-infected beef in a plant or the increased likelihood of

cross-contamination with Salmonella that results from grinding such

infected beef. Since we are persuaded that the Salmonella

performance standard improperly regulates the Salmonella levels of

incoming meat and that Salmonella cross-contamination cannot be an

insanitary condition such that product may be rendered “injurious

to health,” we conclude that the Salmonella performance standard

falls outside of the ambit of § 601(m)(4).

B

1

In order for a product to be adulterated under § 601(m)(4), as

the USDA relies on it here,27 it must be “prepared, packed or held

27
The USDA does not contend that failure of the Salmonella performance
standard serves as a proxy for contamination with filth, the other prong dealt
with by § 601(m)(4). Even if the USDA made such an assertion, § 601(m)(4)
speaks of insanitary conditions such that a product “becomes” contaminated with

14
under insanitary conditions ... whereby it may have been rendered

injurious to health.”28 The use of the word “rendered” in the

statute indicates that a deleterious change in the product must

occur while it is being “prepared, packed or held” owing to

insanitary conditions. Thus, a characteristic of the raw materials

that exists before the product is “prepared, packed or held”29 in

the grinder’s establishment cannot be regulated by the USDA under

§ 601(m)(4).30 The USDA’s interpretation ignores the plain language

of the statute, which includes the word “rendered.” Were we to

adopt this interpretation, we would be ignoring the Court’s

repeated admonition that, when interpreting a statute, we are to

“give effect, if possible, to every clause and word of a statute.”31

The USDA claims, however, that the Salmonella performance

standard serves as a proxy for the presence or absence of pathogen

controls, such that a high level of Salmonella indicates §

filth, which has a similar textual meaning as “rendered.”
28
21 U.S.C. § 601(m)(4) (emphasis added).
29
This case does not require us to define precisely when a product begins
the process of being “prepared, packed or held.” We recognize only that this
process cannot begin until the raw materials are brought to the plant. Thus, the
condition of the raw materials may not be regulated by § 601(m)(4).
30
However, measures that would alter such a characteristic, such as
heating fish to destroy the bacteria that causes botulism, are within the scope
of § 601(m)(4). See Part III.B.2.
31
Duncan v. Walker, 121 S. Ct. 2120, 2125 (2001) (quoting United States
v. Menasche, 348 U.S. 528, 538-39 (1955)).

15
601(m)(4) adulteration.32 Supreme oversimplifies its argument by

claiming, essentially, that the USDA can never use testing of final

product for a non-adulterant, such as Salmonella, as a proxy for

conditions within a plant.

We find a similar, but distinct, defect in the Salmonella

performance standard. The USDA admits that the Salmonella

performance standard provides evidence of: (1) whether or not the

grinder has adequate pathogen controls; and (2) whether or not the

grinder uses raw materials that are disproportionately infected

with Salmonella. Supreme has, at all points in this litigation,

argued that it failed the performance standard not because of any

condition of its facility, but because it purchased beef

“trimmings” that had higher levels of Salmonella than other cuts of

meat. The USDA has not disputed this argument, and has merely

32
We note that the USDA’s assertions on this point are suspect. It is
clear that the motivation behind the Salmonella performance standard was the
regulation of Salmonella itself, and the FSIS has admitted as much in the Final
Rule, though this admission is absent from the USDA’s briefs in this case. See
Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems;
Final Rule, 61 Fed. Reg. 38806, 38850 (“Because testing for E. coli cannot serve
as a surrogate for the presence of Salmonella, FSIS’s specific public health
objective of reducing nationwide Salmonella levels on raw meat and poultry
products, including raw ground products, requires a standard and testing regime
that are directed at that pathogen.” (emphasis added)). The difficulty with
this, of course, is that the USDA has no statutory authority to regulate the
levels of non-adulterant pathogens.
While we do not question the agency’s expertise, we also note that several
equivocal statements about the effectiveness of Salmonella levels as a proxy for
pathogen controls appear in the Final Rule. See Id. at 38835 (“And,
interventions targeted at reducing Salmonella may be beneficial in reducing
contamination by other enteric pathogens.” (emphasis added)); Id. at 38846
(“[I]ntervention strategies aimed at reducing fecal contamination and other
sources of Salmonella on raw product should be effective against other
pathogens.”).

16
argued that this explanation does not exonerate Supreme, because

the Salmonella levels of incoming meat are fairly regulated under

§ 601(m)(4).33 Our textual analysis of § 601(m)(4) shows that it

cannot be used to regulate characteristics of the raw materials

that exist before the meat product is “prepared, packed or held.”

Thus, the regulation fails, but not because it measures Salmonella

levels and Salmonella is a non-adulterant. The performance

standard is invalid because it regulates the procurement of raw

materials.

2

Our determination here is not in tension with the Second

Circuit’s decision interpreting identical language under the Food,

Drug, and Cosmetic Act in United States v. Nova Scotia Food

Products Corp.34 In Nova Scotia the defendant challenged an FDA

regulation requiring the heating of smoked fish to combat the toxin

formation of Clostridium botulinum spores, which cause botulism.

33
The USDA repeatedly asserts that it has the power to regulate the
Salmonella levels of incoming raw materials used in grinding establishments.
See, e.g., Appellant’s Reply Brief at 12 (“To operate in a sanitary manner, a
plant must match the level of its pathogen controls to the nature of the meat it
purchases. The greater the risk of contamination in the incoming product, the
greater the need for strategies to reduce microbial contamination.”); 61 Fed.
Reg. at 38846 (“Establishments producing raw ground product from raw meat or
poultry supplied by other establishments cannot use technologies for reducing
pathogens that are designed for use on the surfaces of whole carcasses at the
time of slaughter. Such establishments may require more control over incoming
raw product, including contractual specifications to ensure that they begin their
process with product that meets the standard ....”) (emphasis added).
34
568 F.2d 240 (2d Cir. 1977).

17
The defendant argued that “the prohibition against ‘insanitary

conditions’ embraces conditions only in the plant itself, but does

not include conditions which merely inhibit the growth of organisms

already in the food when it enters the plant in its raw state.”35

The court gave “insanitary conditions” a broad reading and upheld

the regulation.36 Nevertheless, it conceded that “a plausible

argument can, indeed, be made that the references are to insanitary

conditions in the plant itself, such as the presence of rodents or

insects....”37

While this may appear to conflict with our determination that

pre-existing characteristics of raw materials before they are

“prepared, packed or held” are not within the regulatory reach of

§ 601(m)(4), the regulations at issue in Nova Scotia did not

attempt to control the levels of Clostridium botulinum spores in

incoming fish, as the performance standard does to Salmonella in

incoming raw meat. Instead, the regulations in Nova Scotia required

the use of certain heating and salination procedures to inhibit

growth of the spores.38

35
Id. at 245.

36
Id. at 246 (“When agency rulemaking serves the purposes of the statute,
courts should refuse to adopt a narrow construction of the enabling legislation
which would undercut the agency’s authority to promulgate such rules.”).
37
Id. at 245.
38
Id. at 243 (describing time-temperature-salinity regulations for hot-
process smoked fish). This is consistent with the entirety of cases dealing with
this statute, none of which concern “conditions” extrinsic to the place where the
products are “prepared, packed or held.” See, e.g., United States v. Gel Spice
Co., Inc., 773, F.2d 427, 430 (2d. Cir. 1985) (rodent infestation in plant);

18
 Nova Scotia did not consider the argument before us today,

which is that the statute does not authorize regulation of the

levels of bacterial infection in incoming raw materials. The

argument that Nova Scotia entertained was that “Congress did not

mean to go so far as to require sterilization sufficient to kill

bacteria that may be in the food itself rather than bacteria which

accreted in the factory through the use of insanitary equipment.”39

The required sterilization under the regulations at issue in Nova

Scotia obviously occurred within the plant and did not regulate the

quality of incoming fish.

3

The USDA and its amicus supporters argue that there is no real

distinction between contamination that arrives in raw materials and

contamination that arises from other conditions of the plant. This

is because Salmonella can be transferred from infected meat to non-

infected meat through the grinding process. The Salmonella

performance standard, however, does not purport to measure the

United States v. King’s Trading, Inc., 724 F.2d 631, 632 (8th Cir. 1983) (rodent
infestation in warehouse); United States v. 1,638 Cases of Adulterated Alcoholic
Beverages and Other Articles of Food, 624 F.2d 900, 901-02 (9th Cir. 1980)
(flooding in storage area); United States v. Certified Grocers Co-op, 546 F.2d
1308, 1310-11 (7th Cir. 1976) (rodent infestation in warehouse). Even the USDA
does not argue that § 601(m)(4) reaches “conditions” external to the
establishment, but rather that control of pathogen levels in incoming raw
materials are necessary to maintain sanitary conditions inside of the
establishment. See Appellant’s Brief at 38-39.
39
Id. at 246.

19
differential between incoming and outgoing meat products in terms

of the Salmonella infection rate. Rather, it measures final meat

product for Salmonella infection. Thus, the performance standard,

of itself, cannot serve as a proxy for cross-contamination because

there is no determination of the incoming Salmonella baseline.

Moreover, the USDA has not asserted that there is any

correlation between the presence of Salmonella and the presence of

§ 601(m)(1) adulterant pathogens. The rationale offered by the

USDA for the Salmonella performance standard—that “intervention

strategies aimed at reducing fecal contamination and other sources

of Salmonella on raw product should be effective against other

pathogens”40—does not imply that the presence of Salmonella

indicates the presence of these other, presumably § 601(m)(1)

adulterant, pathogens.41 Cross-contamination of Salmonella alone

cannot form the basis of a determination that a plant’s products

are § 601(m)(4) adulterated, because Salmonella itself does not

render a product “injurious to health” for purposes of both §§

601(m)(1) and 601(m)(4).

40
61 Fed. Reg. at 38846.
41
One might speculate that such a conclusion would create problems for the
USDA, because a statement that Salmonella was a proxy for, for example,
pathogenic E. coli could arguably require the determination that the presence of
Salmonella rendered a product § 601(m)(1) adulterated. This would prevent
Salmonella-infected meat from being sold in the United States to consumers.

20
 Not once does the USDA assert that Salmonella infection

indicates infection with § 601(m)(1) adulterant pathogens.42

Instead, the USDA argues that the Salmonella infection rate of meat

product correlates with the use of pathogen control mechanisms and

the quality of the incoming raw materials. The former is within

the reach of § 601(m)(4), the latter is not.

IV

Because we find that the Salmonella performance standard

conflicts with the plain language of 21 U.S.C. § 601(m)(4), we need

not reach Supreme’s numerous alternative arguments for invalidating

the standard, which were not addressed by the district court.

V

We AFFIRM and REMAND with instructions that the final judgment

of the district court be amended to include the National Meat

Association.

42
The amicus curiae consumer groups in their brief appear not to recognize
the distinction between a correlation between Salmonella and other enteric
pathogens in raw materials and a correlation between reductions in Salmonella and
reductions in other enteric pathogens when the same control methods are used.
See Brief of Amicus Curiae Consumer Groups at 10-11.

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