United States Court of Appeals, District of Columbia Circuit
April 20, 2017
Petition for Review from a Decision of the Food Safety and
Inspection Service of the United States Department of
H. Gardner argued the cause for the petitioner. Andrew H.
Baida and David M. Wyand were with him on brief.
F. Busa, Attorney, United States Department of Justice,
argued the cause for the respondents. Benjamin C. Mizer,
Principal Deputy Assistant Attorney General at the time the
brief was filed, and Mark B. Stern, Attorney, were with him
Before: Henderson and Kavanaugh, Circuit Judges, and
Sentelle, Senior Circuit Judge.
LeCraft Henderson, Circuit Judge.
the Federal Meat Inspection Act of 1907 ("FMIA"),
21 U.S.C. §§ 601 et seq., and implementing
regulations, the Food Safety and Inspection Service
("FSIS"), an agency of the United States Department
of Agriculture ("USDA"), is charged with ensuring,
inter alia, that certain commercial meat products
are not misbranded. If the FSIS determines that a meat
product's labeling is "false or misleading in any
particular, " 21 U.S.C. § 607(e), it can prohibit
its use. Pursuant to that authority, the FSIS determined that
the packaging used by United Source One, Inc.
("US1"), a meat exporter, was misbranded because
its label included the FSIS inspection identification number
of its supplier without the latter's permission. For the
reasons that follow, we deny US1's petition for review.
Congress enacted the FMIA to protect "the health and
welfare of consumers . . . by assuring that meat and meat
food products distributed to them are wholesome, not
adulterated, and properly marked, labeled, and
packaged." 21 U.S.C. § 602. To that end, the FMIA
mandates inspection of certain commercial meat products as
well as the facilities-referred to as "official
establishments"-where those products are handled.
Id. § 608. By regulation, the FSIS carries out
that mandate. 9 C.F.R. § 300.2(b)(1). "[D]ay or
night, " FSIS inspectors have access to an official
establishment to ensure that it operates in sanitary
conditions and that its meat is not "adulterated."
21 U.S.C. § 606(a). Commercial meat products that meet
the FMIA's standards are marked as "[i]nspected and
passed." Id. At 9 C.F.R. § 312.2, the
following example of an "official mark" of
FSIS inspection mark includes a unique establishment
number that identifies the product as having been
"prepared" in the facility to which the
establishment number belongs. 9 C.F.R. § 305.1(a)
("An official number shall be assigned to each
establishment granted inspection . . . [and] shall be used to
identify all inspected and passed products prepared in the
establishment."). An authorized FSIS inspection mark
ordinarily must appear both on the "immediate
container" of a commercial meat product, for example,
vacuum packaging, id. § 317.1, and on any
external container, for example, a shipping box, see
id. § 316.13.
an official establishment does not ship its products directly
to the end-use consumer. Instead, an official establishment
ships meat to a "re-boxing" facility, a middleman
operation that repackages and resells meat, often under a
different brand name. Because the re-boxer itself does not
slaughter meat, it is not subject to the FMIA's
mandatory inspection requirements. See 21
U.S.C. § 608 ("The Secretary shall cause to be made
. . . such inspection of all . . . establishments in which
amenable species are slaughtered and the meat and meat food
products thereof are prepared for commerce . . . .").
Nonetheless, the Agricultural Marketing Act of 1946
("AMA"), 7 U.S.C. §§ 1621 et
seq., and implementing regulations provide that a
re-boxing facility may voluntarily pay for and obtain FSIS
identification services. See 9 C.F.R. § 350.3.
FSIS Directive 12, 600.1, adopted pursuant to the AMA,
provides guidance on the implementation/enforcement of those
services. See FSIS Directive 12, 600.1, Voluntary
Reimbursable Inspection Services (U.S.D.A. 2007) (hereinafter
"Directive 12, 600.1"). Once the re-boxer
participates, the FSIS inspection works, inter alia,
to "ensure that the identity of federally-inspected and
passed meat . . . is maintained throughout the division of
such meat . . . into smaller portions, its combination into
larger units, or its repackaging and relabeling."
Id. at 3. If the FSIS "determine[s] that the
identity [of the repackaged meat] has been maintained, "
that is, the meat has not been adulterated once it has passed
its official establishment inspection, the FSIS "mark[s]
such portions or units [of the repackaged meat] with the
marks of Federal inspection." 9 C.F.R. §
an official establishment, the FSIS assigns each re-boxing
facility its own, unique establishment number that is
included as part of the inspection mark on the re-boxer's
label. See Directive 12, 600.1 at 6 ("If the
[re-boxing] facility meets the requirements for the requested
service(s), the [FSIS] will request the next available
[establishment] number through the Resource Information
System . . . [and] assign the number to the facility . . .
."). Unlike an official establishment's
establishment number, however, which begins with
"P" or "M, " etc., to designate that it
is subject to poultry or meat inspections, respectively,
see supra 4 n.2, a re-boxer's establishment
number begins with "V" to indicate that the FSIS
inspection conducted there is pursuant to the AMA inspection
regime. See Food Safety Inspection Serv., FSIS Meat,
Poultry and Egg Product Inspection Directory Legend for
Establishment Numbers and Directory Search Guidance 1 (2017);
accord JA 15, 69-70 (indicating US1's
establishment number is "V21467"). Nevertheless,
FSIS Directive 12, 600.1 provides that a re-boxer may use its
supplier's establishment number on its label if
certain conditions are met:
Whenever labeling with the originating official establishment
number is used by [a re-boxing] facility (i.e., labeling
depicting the official number of the establishment that
produced the product), inspection program personnel will
verify that the [re-boxing] facility code marks the product
in a manner that will clearly indicate that the product was
last handled and labeled at the [re-boxing] facility. The
[re-boxing] facility must maintain records of label transfers
and records of products labeled or relabeled at ...