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| [1] | IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT |
| [2] | No. 00-11008 |
| [3] | 2001.C05.0000562 <http://www.versuslaw.com> |
| [4] | December 6, 2001 |
| [5] | SUPREME BEEF PROCESSORS, INC, PLAINTIFF-APPELLEE, v. UNITED STATES DEPARTMENT OF AGRICULTURE, DEFENDANT-APPELLANT. |
| [6] | Before Reavley, Higginbotham, and Parker, Circuit Judges. |
| [7] | The opinion of the court was delivered by: Patrick E. Higginbotham, Circuit
Judge. |
| [8] | Appeal from the United States District Court For the Northern District
of Texas |
| [9] | 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. |
| [10] | I. |
| [11] | The Federal Meat Inspection Act authorizes the Secretary of Agriculture
to "prescribe the rules and regulations of sanitation" covering |
| [12] | 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....*fn1 |
| [13] | Further, the Secretary is commanded to, |
| [14] | 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."*fn2 |
| [15] | 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.*fn3 |
| [16] | 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."*fn4
Thus, the FMIA gives the Secretary the power to create sanitation 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. |
| [17] | 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."*fn5
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. |
| [18] | 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.*fn6
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."*fn7
The performance standard, or "passing mark," is determined based
on FSIS's "calculation of the national prevalence of Salmonella on
the indicated raw product."*fn8 |
| [19] | 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,*fn9 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. |
| [20] | 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 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. |
| [21] | 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. |
| [22] | 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. |
| [23] | 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. |
| [24] | 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. |
| [25] | II. |
| [26] | 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 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. |
| [27] | 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,*fn10
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."*fn11
The possibility that Supreme may continue to function as a meat processor
even after its Chapter 7 proceeding satisfies Article III.*fn12 |
| [28] | 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: |
| [29] | 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").... |
| [30] | 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. |
| [31] | 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. |
| [32] | 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 intervenor asserts an interest that is 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 intervenor's ability to protect [its] interest;
and (4) the existing parties do not adequately represent the potential intervenor's
interest."*fn13 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),*fn14
and we address only adequacy of representation here. |
| [33] | 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 Supreme's representation
"may be" inadequate,*fn15
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.*fn16 |
| [34] | 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. |
| [35] | III. |
| [36] | 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.*fn17 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 with
the text.*fn18 Then, "[i]f the
agency interpretation is not in conflict with the plain language of the
statute, deference is due."*fn19
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. |
| [37] | A. |
| [38] | 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 |
| [39] | 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. |
| [40] | This statutory definition is broader than that provided in 21 U.S.C. §
601(m)(1), which provides that a meat product is adulterated |
| [41] | 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. |
| [42] | 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."*fn20 |
| [43] | 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,*fn21 meaning its presence does
not require the USDA to refuse to stamp such meat "inspected and passed."*fn22
This is because normal cooking practices for meat and poultry destroy the
Salmonella organism,*fn23 and therefore
the presence of Salmonella in meat products does not render them "injurious
to health"*fn24 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. |
| [44] | 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 pathogen*fn25
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. |
| [45] | 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)."*fn26
The district court therefore held that the examination of a plant's end
product is distinct from "conditions" within the plant for purposes
of § 601(m)(4) because Salmonella may have come in with the raw material. |
| [46] | 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). |
| [47] | B. |
| [48] | 1. |
| [49] | In order for a product to be adulterated under § 601(m)(4), as the USDA
relies on it here,*fn27 it must be "prepared,
packed or held under insanitary conditions ... whereby it may have been
rendered injurious to health."*fn28
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"*fn29 in the grinder's
establishment cannot be regulated by the USDA under § 601(m)(4).*fn30
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."*fn31 |
| [50] | 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 § 601(m)(4) adulteration.*fn32
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. |
| [51] | 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 argued that this explanation does
not exonerate Supreme, because the Salmonella levels of incoming meat are
fairly regulated under § 601(m)(4).*fn33
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. |
| [52] | 2. |
| [53] | 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.*fn34
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. 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."*fn35
The court gave "insanitary conditions" a broad reading and upheld
the regulation.*fn36 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...."*fn37 |
| [54] | 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.*fn38 |
| [55] | 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."*fn39
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. |
| [56] | 3. |
| [57] | 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 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"*fn40--does
not imply that the presence of Salmonella indicates the presence of these
other, presumably § 601(m)(1) adulterant, pathogens.*fn41
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). |
| [58] | Not once does the USDA assert that Salmonella infection indicates infection
with § 601(m)(1) adulterant pathogens.*fn42
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. |
| [59] | IV. |
| [60] | 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. |
| [61] | V. |
| [62] | We AFFIRM and REMAND with instructions that the final judgment of the
district court be amended to include the National Meat Association. |
|
|
|
| Opinion Footnotes | |
|
|
|
| [63] | *fn1 21 U.S.C. § 608. |
| [64] | *fn2 Id. |
| [65] | *fn3 The FMIA requires that adulterated
meat products be stamped "inspected and condemned" and destroyed.
21 U.S.C. § 606. |
| [66] | *fn4 Id. § 601(m)(4). |
| [67] | *fn5 9 C.F.R. Pt. 417. |
| [68] | *fn6 Id. § 310.25(b). |
| [69] | *fn7 Id. § 310.25(b)(3)(iii). |
| [70] | *fn8 Id. § 310.25(b)(2) tbl. 2 n.a. |
| [71] | *fn9 The performance standard for raw
ground beef is 7.5 percent. Id. |
| [72] | *fn10 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))). |
| [73] | *fn11 Sierra Club v. Glickman, 156
F.3d 606, 619 (5th Cir. 1998). |
| [74] | *fn12 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 review. |
| [75] | *fn13 John Doe No. 1. v. Glickman,
256 F.3d 371, 375 (5th Cir. 2001). |
| [76] | *fn14 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). |
| [77] | *fn15 Sierra Club v. Espy, 18 F.3d
1202, 1207 (5th Cir. 1994). |
| [78] | *fn16 See, e.g., Goodman v. Heublein,
682 F.2d 44, 47 (2d. Cir. 1987) (granting motion to intervene in part to
avoid piecemeal litigation). |
| [79] | *fn17 467 U.S. 837 (1984). |
| [80] | *fn18 Nat'l R.R. Passenger Corp. v.
Boston & Maine Corp., 503 U.S. 407, 417 (1992). |
| [81] | *fn19 Id. |
| [82] | *fn20 21 U.S.C. § 608. |
| [83] | *fn21 See American Pub. Health Ass'n
v. Butz, 511 F.2d 331, 334 (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. |
| [84] | *fn22 21 U.S.C. § 608. |
| [85] | *fn23 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."). |
| [86] | *fn24 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). |
| [87] | *fn25 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. |
| [88] | *fn26 Supreme Beef Processors, Inc.
v. USDA, 113 F. Supp.2d 1048, 1052-53 (N.D. Tex. 2000) (emphasis in original). |
| [89] | *fn27 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 filth, which has a
similar textual meaning as "rendered." |
| [90] | *fn28 21 U.S.C. § 601(m)(4) (emphasis
added). |
| [91] | *fn29 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). |
| [92] | *fn30 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. |
| [93] | *fn31 Duncan v. Walker, 121 S. Ct.
2120, 2125 (2001) (quoting United States v. Menasche, 348 U.S. 528, 538-39
(1955)). |
| [94] | *fn32 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."). |
| [95] | *fn33 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). |
| [96] | *fn34 568 F.2d 240 (2d Cir. 1977). |
| [97] | *fn35 Id. at 245. |
| [98] | *fn36 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."). |
| [99] | *fn37 Id. at 245. |
| [100] | *fn38 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); 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. |
| [101] | *fn39 Id. at 246. |
| [102] | *fn40 61 Fed. Reg. at 38846. |
| [103] | *fn41 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. |
| [104] | *fn42 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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