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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