Creekstone Farms Premium Beef, L.L.C v. Department of Agriculture

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 9, 2008 Decided August 29, 2008

No. 07-5173

CREEKSTONE FARMS PREMIUM BEEF, L.L.C.,
APPELLEE/CROSS-APPELLANT

v.

DEPARTMENT OF AGRICULTURE AND EDWARD T. SCHAFER,
SECRETARY OF AGRICULTURE,
APPELLANTS/CROSS-APPELLEES

Consolidated with NO. 07-5199

Appeals from the United States District Court
for the District of Columbia
(No. 06cv00544)

Eric Fleisig-Greene, Attorney, United States Department of
Justice, argued the cause for the appellants/cross-appellees.
Jeffrey S. Bucholtz, Acting Assistant Attorney General, Jeffrey
A. Taylor, United States Attorney, and Mark B. Stern and
Michael S. Raab, Attorneys, United States Department of
Justice, were on brief. James J. Gilligan, Attorney, United
States Department of Justice, and R. Craig Lawrence, Assistant
United States Attorney, entered appearances.
 2

Russell S. Frye argued the cause for the appellee/cross-
appellant. Peter C. Choharis entered an appearance.
Before: SENTELLE, Chief Judge, HENDERSON and ROGERS,
Circuit Judges.
Opinion for the court filed by Circuit Judge HENDERSON.
Concurring opinion filed by Circuit Judge ROGERS.
Dissenting opinion filed by Chief Judge SENTELLE.
KAREN LECRAFT HENDERSON, Circuit Judge: Creekstone
Farms Premium Beef, LLC (Creekstone) raises and slaughters
for sale Black Angus cattle. In December 2003, many countries
began to ban or severely limit importation of U.S. beef because
bovine spongiform encephalopathy (BSE)—“mad cow
disease”—had been found in one cow in Washington State. See
U.S. Dep’t of Agric., Publ’n No. LDP-M-143-01, An Economic
Chronology of Bovine Spongiform Encephalopathy in North
America 4 (2006) (Economic Chronology). To counter the fears
of beef importers as well as domestic consumers, Creekstone
developed a plan to test for BSE each of the approximately
300,000 cattle it slaughters each year. Declaration of John D.
Stewart ¶ 6 (July 13, 2006) (Stewart Decl.). The United States
Department of Agriculture (USDA), however, asserting
authority under the Virus-Serum-Toxin Act, 21 U.S.C. §§ 151-
59 (VSTA or Act), denied Creekstone’s request to purchase or
use a BSE test kit. Creekstone challenged the USDA’s action in
the district court, alleging that two of USDA’s regulations are
ultra vires under VSTA and that, even assuming the regulations
are valid, they do not authorize USDA’s restriction on the
sale/use of the BSE test kit. Creekstone also challenged
USDA’s interpretation of another regulation. Both parties
moved for summary judgment and the district court granted
partial summary judgment to each party. 517 F. Supp. 2d 8, 13-
16 (D.D.C. 2007). For the reasons explained below, we affirm
in part and reverse in part.
 3

I.
A. Statutory/Regulatory Background
The Congress enacted VSTA in 1913 following reports that
farmers were being sold ineffective anti-hog cholera serum. See
Agriculture Appropriation Bill: Hearings Before the Senate
Comm. on Agric., 62d Cong. 23-24 (1913) (testimony of A.M.
Farrington, Asst. Chief, Bureau of Animal Indus., USDA). The
Act makes it “unlawful . . . to prepare, sell, barter, or
exchange . . . or to ship or deliver for shipment . . . any
worthless, contaminated, dangerous, or harmful virus, serum,
toxin, or analogous product intended for use in the treatment of
domestic animals.” 21 U.S.C. § 151 (emphasis added). To this
end, VSTA requires that “any virus, serum, toxin, or analogous
product manufactured within the United States and intended for
use in the treatment of domestic animals . . . [be] prepared,
under and in compliance with regulations prescribed by the
Secretary of Agriculture, at an establishment holding [a] license
issued by the Secretary of Agriculture” (Secretary). Id.
(emphasis added). In addition, VSTA makes it illegal to import
“any virus, serum, toxin, or analogous product for use in the
treatment of domestic animals” without a permit from the
Secretary. Id. § 152. To implement the Act, the Secretary is
authorized “to make and promulgate from time to time such
rules and regulations as may be necessary to prevent the
preparation, sale, barter, exchange, or shipment . . . of any
worthless, contaminated, dangerous, or harmful virus, serum,
toxin, or analogous product for use in the treatment of domestic
animals, or otherwise to carry out [VSTA].” Id. § 154
(emphasis added).1

1
Any violation of VSTA is a misdemeanor “punish[able] by
a fine of not exceeding $1,000 or by imprisonment not
 4

USDA has promulgated several regulations implementing
VSTA. One regulation under review provides that “[w]here the
Administrator [of USDA’s Animal and Plant Health Inspection
Service (APHIS)] determines that the protection of domestic
animals or the public health, interest, or safety, or both,
necessitates restrictions on the use of a [biological] product, the
product shall be subject to . . . restrictions as . . . prescribed on
the license.” 9 C.F.R. § 102.5(d).2 The second regulation under
review provides that “[n]o biological product shall be brought
into the United States unless a permit has been issued for such
product” by the APHIS Administrator. 9 C.F.R. § 104.1(a).
“Biological products” include “all viruses, serums, toxins, . . . or
analogous products . . . which are intended for use in the
treatment of animals and which act primarily through the direct
stimulation, supplementation, enhancement, or modulation of
the immune system or immune response.” 9 C.F.R. § 101.2
(emphasis added). “Analogous products” are defined, in
relevant part, as “[s]ubstances . . . which are intended for use in
the treatment of animals through the detection or measurement
of antigens, antibodies, nucleic acids, or immunity.” Id.
§ 101.2(2)(ii) (emphasis added). “Treatment” is defined as the
“prevention, diagnosis, management, or cure of diseases of
animals.” Id. § 101.2(3) (emphasis added).
B. Bovine Spongiform Encephalopathy
BSE is an invariably fatal neurological disease that causes

exceeding one year, or by both such fine and imprisonment.” 21
U.S.C. § 158.
2
The APHIS Administrator issues the relevant license,
namely a U.S. veterinary biological product license. 9 C.F.R.
§ 102.5(a).
 5

degeneration of the cow’s central nervous system. See Bovine
Spongiform Encephalopathy, 70 Fed. Reg. 460, 461 (Jan. 4,
2005). BSE is believed to be caused by a type of protein called
a “prion.” Declaration of Lisa A. Ferguson ¶ 3 (Sept. 20, 2006)
(Ferguson Decl.). Prions exist naturally in the nerve cells of
many animals and are believed to help maintain normal cell
function; however, the protein also exists in an abnormal form
which causes BSE. Stanley B. Prusiner, Detecting Mad Cow
Disease, Scientific American, July 2004, at 86 (Creekstone Mot.
Summ. J. Ex. 3) (CX-3). BSE occurs when healthy cattle are
fed the remains of an animal (ruminant) infected with
abnormally formed prions. Ferguson Decl. ¶ 3. As abnormal
prions accumulate within the brain cells, they cause the cells to
rupture, resulting in a loss of coordination and ultimately the
death of the animal. See CX-3, at 88; Ferguson Decl. ¶ 5.
Prions that cause BSE in cattle can cause a similar disease in
humans known as variant Cruetzfeldt-Jakob Disease (vCJD).
Ferguson Decl. ¶ 7. Since 1986, approximately 190 people—
95% of whom resided in the United Kingdom—have died as a
result of confirmed cases of vCJD. Id. It is believed that
humans can contract vCJD by consuming BSE-contaminated
beef or beef products. Id.
BSE was first diagnosed in the United Kingdom in 1986.
Id. ¶ 4. Since then, more than 189,000 confirmed cases of BSE
in cattle worldwide have been reported. Id. While almost all of
the cases (95%) have occurred in the United Kingdom, BSE has
been found in cattle raised in at least twenty-five other countries.
Id. In 1989, USDA banned the importation of ruminant
products from countries with known BSE-infected cattle. See 9
C.F.R. §§ 93.401, 94.18; Ferguson Decl. ¶ 8. In 1990, APHIS
began a surveillance program to determine the existence vel non
of BSE in the nation’s cattle and to evaluate the effectiveness of
its import restriction in preventing the spread of the disease.
 6

Ferguson Decl. ¶ 9. In 1997, the United States Food and Drug
Administration (FDA) banned the use of all ruminant feed for
cattle. See Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed, 62 Fed.
Reg. 30,936, 30,976 (June 5, 1997) (codified at 21 C.F.R.
§ 589.2000). Despite these efforts, however, three BSE-infected
cows have been found in the United States. The first was
reported in December 2003 in a Canadian-born cow in
Washington State. Economic Chronology 4. In June 2004
APHIS initiated a 26-month “enhanced BSE surveillance
program” under which APHIS tested over 750,000 cattle for
BSE. Ferguson Decl. ¶ 9; 517 F. Supp. 2d at 10. Two more
BSE-infected cattle were found—one in Texas in June 2005 and
one in Alabama in March 2006. Economic Chronology 5. In
July 2006, USDA announced that in light of “the extremely low
prevalence of the disease in the U.S.,” it intended to reduce the
number of cattle tested to approximately 40,000 per
year—approximately 1% of the total number of cattle
slaughtered in the United States. USDA Press Release No.
0255.06 (July 20, 2006); Declaration of Paul W. Brown ¶ 15
(Oct. 27, 2006).
There are several types of BSE tests available; the most
common—and the one at issue here—is the immunoassay, or
“rapid,” BSE test.3 See CX-3, at 89-91. The rapid BSE test,

3
The rapid BSE test is so named because it can produce
results in approximately eight hours. Other methods of testing
(for example, the immunohistochemistry and bioassay methods)
can take up to seven days or 36 months, respectively, to produce
results. CX-3, at 90. With the rapid BSE test, tissue is
harvested from the carcass’s brain and treated with an enzyme
which removes normally formed prions. Id. at 89. The sample
 7

however, has limitations. It can detect abnormal prions only if
they exist in a relatively high concentration, id. at 91, and
abnormal prions typically reach detectable concentrations only
two to three months before an animal exhibits observable
symptoms. See Declaration of Byron Rippke ¶ 9 (Sept. 12,
2006). The incubation period for BSE (i.e., from infection to
observable symptoms) is two to eight years—the average being
five years—and cattle younger than thirty months are rarely
symptomatic. Ferguson Decl. ¶ 5. Because most cattle for
slaughter in the United States go to market before they are
twenty-four months old, it is unlikely that the rapid BSE test will
detect the disease. Id. In light of the rapid BSE test’s limited
efficacy, USDA believes that the routine use of the test on
“clinically normal young cattle is not practical[], offers no food
safety value,” is “likely [to] produce false negative results” and
is “meaningful and reliable . . . when used for surveillance
purposes on . . . animals exhibiting some type of clinical
abnormality that could be consistent with BSE” (e.g., cattle that
cannot stand or walk, show signs of neurological disorders or
die from an unknown cause). Ferguson Decl. ¶ 6.
Following the discovery of the first BSE-infected cow in
Washington State, several major beef importing countries,
including Japan, South Korea and Mexico (at the time three of
the four largest importers), banned the importation of U.S. beef.
Economic Chronology 4. Some countries have since resumed
importing U.S. beef; however, Japan and South Korea have done
so only intermittently and subject to restrictions. See

is then treated with an antibody that binds to any abnormal
prion. Id. By measuring the amount of any antibody that binds,
the presence of BSE can be determined in a matter of hours. See
id. at 90.
 8

Supplemental Declaration of John D. Stewart ¶ 5 (Oct. 31,
2006).
C. Creekstone’s Response to Market Loss
Creekstone claims to have suffered $200,000 per day in lost
revenue as a result of the diminished export market. Stewart
Decl. ¶ 17. Moreover, in markets where U.S. beef is available,
Creekstone contends that consumer fears about BSE have
diminished its sales. See Id. ¶¶ 4, 5 (discussing market surveys
in Japan and U.S.). To allay the concerns of consumers and
importers, in 2004 Creekstone made a “business decision” to
perform the rapid BSE test on each cow it slaughters. Compl.
¶ 20. Creekstone sought to purchase rapid BSE test kits from
Bio-Rad Laboratories, Inc. (Bio-Rad).4 Bio-Rad informed
Creekstone, however, that it could not sell Creekstone the kits
without USDA authorization. On February 19, 2004, and in
several later communications, Creekstone requested USDA
permission to purchase the test kits. Id. ¶ 21. USDA denied
Creekstone’s requests. On March 17, 2004, USDA’s Center for
Veterinary Biologics issued Notice No. 04-08, ordering that the
“[s]ale and use” of all BSE test kits be restricted to USDA-
approved laboratories only. See USDA, Ctr. For Veterinary
Biologics Notice No. 04-08 (Mar. 17, 2004). The Notice also
declared that the “distribution and use” of all BSE test kits was
to be under the “supervision or control of USDA.” Id.5

4
Bio-Rad, a California corporation, manufactures rapid BSE
test kits in France and imports them into this country under a
USDA permit. See United States Veterinary Biological Product
Permit No. 624, Bio-Rad Laboratories (Mar. 4, 2005).
5
The USDA issued the Notice under 9 C.F.R. §§ 102.5(d)
and 104.1.
 9

Accordingly, Bio-Rad’s import permit authorizes it to sell BSE
test kits to USDA-approved laboratories only. U.S. Veterinary
Prod. Permit No. 624, Bio-Rad Labs., at 2 (Mar. 4, 2005).
USDA memorialized its decision to deny Creekstone permission
to purchase rapid BSE test kits from Bio-Rad in a June 1, 2004
letter, concluding that “allowing a company to use a BSE test in
a private marketing program is inconsistent with USDA’s
mandate to ensure effective, scientifically sound testing for
significant animal diseases and maintain domestic and
international confidence in U.S. cattle and beef products.”
Letter from Bill Hawkes, USDA, to John D. Stewart, Creekstone
Farms (June 1, 2004).6
On March 23, 2006, Creekstone filed a three-count
complaint in the district court. Count I claimed, inter alia, that
because VSTA “provides no authorization at all for restrictions
on the use of products,” USDA’s regulation purporting to
regulate the use of biological products is ultra vires. Compl.
¶ 32 (emphasis added). Count I also claimed that USDA’s
definition of “treatment” contained in regulation section 101.2
goes “beyond the scope of the rulemaking authority granted to
USDA in the VSTA.” Id. ¶ 31. Count II challenged USDA’s
regulation of BSE testing because it “[is] not used in the

6
At the suggestion of a USDA official, Creekstone
subsequently asked USDA to allow Kansas State University
(KSU) to designate Creekstone’s Arkansas City, Kansas facility
as a satellite laboratory for KSU’s USDA-authorized BSE
testing program. USDA rejected the request, explaining that
“BSE testing is an inherently governmental function that must
be conducted by Federal and State laboratories.” Letter from
Randall L. Levings, USDA, to Ralph Richardson, Kansas State
University (Aug. 5, 2004).
 10

treatment of domestic animals and do[es] not ‘act primarily
through the direct stimulation, supplementation, enhancement or
modulation of the immune system or immune response,’ as
required by 9 C.F.R. § 101.2.” Compl. ¶ 40. Finally, Count III
alleged that USDA’s denial of Creekstone’s request to perform
BSE testing is arbitrary and capricious in violation of the
Administrative Procedure Act, 5 U.S.C. § 706(2)(A). Compl.
¶¶ 42-51.
The parties filed cross-motions for summary judgment on
Counts I and II of Creekstone’s complaint. On March 29, 2007,
the district court granted summary judgment to USDA on Count
I and to Creekstone on Count II. The court first rejected
Creekstone’s argument that USDA lacked the authority to
regulate the “use” of products under section 154 of the Act. 517
F. Supp. 2d at 13 (“Creekstone contends that USDA’s ‘use’
regulation exceeds its authority to regulate ‘preparation, sale,
barter, exchange, or shipment,’ but Creekstone’s reading of the
statute is too narrow.”). The court also upheld USDA’s broad
interpretation of “treatment” in sections 151-155 of the Act. Id.
at 15-16. On Count II, however, the court concluded that USDA
cannot regulate BSE testing because it cannot be used in the
treatment of domestic animals. Id. at 16. The court reasoned
that, because there is no known cure for BSE and because
testing can be done only post-mortem, rapid BSE test kits are
not used for “treatment” as that term is defined in 9 C.F.R.
§ 101.2(3). Id. at 16. Neither party moved for summary
judgment on Count III. See 517 F. Supp. 2d at 12 n.5.7 Both

7
In district court USDA challenged Creekstone’s standing
and also asserted a mootness defense based on “Japan’s decision
in July 2006 to resume imports of U.S. beef.” 517 F. Supp. 2d
at 12. USDA has pursued neither argument on appeal.
 11

parties timely appealed.
II.
We review de novo the district court’s grant of summary
judgment. Nat’l Mining Ass’n v. Kempthorne, 512 F.3d 702,
707 (D.C. Cir. 2008). We affirm a grant of summary judgment
only if “there is no genuine issue as to any material fact and . . .
the movant is entitled to judgment as a matter of law.” Fed. R.
Civ. P. 56(c). In making this determination, we view the
material facts in the light most favorable to the non-moving
party. Johnson v. District of Columbia, 528 F.3d 969, 973 (D.C.
Cir. 2008) (citing Saucier v. Katz, 533 U.S. 194, 201 (2001)).
A. Count I
1. USDA’s “use” regulations8
We first address the question whether USDA can regulate
the use of biological products under VSTA. VSTA authorizes
USDA to promulgate regulations under two circumstances set
forth in 21 U.S.C. § 154. First, section 154 authorizes USDA to
promulgate “such rules and regulations as may be necessary to
prevent the preparation, sale, barter, exchange, or shipment . . .
of any worthless, contaminated, dangerous, or harmful virus,
serum, toxin, or analogous product for use in the treatment of
domestic animals.” 21 U.S.C. § 154. This language authorizes
regulations directed at discrete activities—preparation, sale,
barter, exchange and shipment—and discrete products—viruses,

8
We use the term “use” regulations to refer to 9 C.F.R.
§§ 102.5(d) and 104.1.
 12

serums, toxins or analogous products.9 But this language is also
limited to products that are “worthless, contaminated,
dangerous, or harmful” and plainly the rapid BSE test kit cannot
be so described. Section 154 further provides that USDA may
promulgate “such rules and regulations as may be necessary . . .
otherwise to carry out this chapter.” Id. USDA contends that
under Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc.,
467 U.S. 837 (1984), this broad language authorizes it to
regulate the use of biological products. We conclude instead
that the applicable standard of review is that set out in Skidmore
v. Swift & Co., 323 U.S. 134 (1944).
Ordinarily, we review an agency’s interpretation of a statute
that it administers under Chevron. We first ask “whether
Congress has directly spoken to the precise question at issue.”
Id. at 842. If so, “that is the end of the matter” and we “must
give effect to the unambiguously expressed intent of Congress.”
Id. at 842-43. However, if “the statute is silent or ambiguous
with respect to the specific issue,” we move to the second step
and must defer to the agency’s interpretation as long as it is
“based on a permissible construction of the statute.” Id. at 843.
In this case, however, we agree with Creekstone that Chevron
does not apply to the “otherwise to carry out” language because
that language was not added to the statute until 1985, see Food
Security Act of 1985, Pub. L. No. 99-198, § 1768(b), 99 Stat.
1354, 1654 (1985)—almost ten years after USDA promulgated
the predecessor of section 102.5(d). See Deletion of Special
Licenses, 41 Fed. Reg. 44,358, 44,359 (Oct. 8, 1976). USDA

9
Section 154 applies to both imported products and to
products manufactured in the United States. See 121 U.S.C.
§ 151 (U.S.-manufactured products); id. § 152 (imported
products).
 13

may not reasonably rely on statutory language that did not exist
when it first adopted its regulation. See Pub. Citizen, Inc. v.
U.S. Dep’t of Health & Human Servs., 332 F.3d 654, 659 (D.C.
Cir. 2003) (applying Skidmore deference to regulation
promulgated before amendment of statute). As the district court
correctly noted, however, even without Chevron deference,
USDA’s “use” regulations nonetheless “remain[] entitled to a
‘degree of deference’ under Skidmore v. Swift & Co., 323 U.S.
134 (1944).” 517 F. Supp. 2d at 14 (quoting Pub. Citizen, 332
F.3d at 662).
Under Skidmore, “ ‘[t]he weight [accorded to an
administrative judgment] in a particular case will depend upon
the thoroughness evident in its consideration, the validity of its
reasoning, its consistency with earlier and later pronouncements,
and all those factors which give it power to persuade, if lacking
power to control.’ ” United States v. Mead Corp., 533 U.S. 218,
228 (2001) (quoting Skidmore, 323 U.S. at 140) (second
alteration in Mead); see Am. Fed’n of Gov’t Employees v.
Veneman, 284 F.3d 125, 129 (D.C. Cir. 2002) (under Skidmore
“USDA’s view . . . constitutes ‘a body of experience and
informed judgment’ to which we may properly resort for
guidance” (quoting Skidmore, 323 U.S. at 140)). USDA’s
promulgation of section 102.5(d) satisfies Skidmore’s standard.
As previously noted, section 102.5(d) provides that, once
the APHIS Administrator “determines that the protection of
domestic animals or the public health, interest, or safety, or both,
necessitates restrictions on the use of a product, the product shall
be subject to such additional restrictions as are prescribed on the
license,” including “limits on the distribution of the product.”
9 C.F.R. § 102.5(d) (emphases added). We believe regulation
102.5(d), which permits restrictions on the “use” of biological
products, reflects considered agency deliberation, has been
consistently applied since 1976 and is reasonably related to the
 14

purposes of VSTA, namely, to ensure the safety and efficacy of
any product that is intended to be used in treating domestic
animals. See, e.g., 21 U.S.C. §§ 151 (making it illegal to
“prepare, sell, barter, exchange, or ship . . . any virus, serum,
toxin, or analogous product manufactured within the United
States and intended for use in the treatment of domestic animals,
unless . . . [it] shall have been prepared, under and in compliance
with regulations prescribed by the Secretary”) (emphases
added), 152 (requiring USDA permit to import “any virus,
serum, toxin, or analogous product for use in the treatment of
domestic animals”) (emphases added), 153 (authorizing
Secretary to inspect “all viruses, serums, toxins, and analogous
products, for use in the treatment of domestic animals, which are
being imported or offered for importation into the United
States”) (emphases added), 155 (authorizing Secretary “to issue
permits for the importation into the United States of viruses,
serums, toxins, and analogous products, for use in the treatment
of domestic animals, which are not worthless, contaminated,
dangerous or harmful”) (emphasis added); see Fed. Express
Corp. v. Holowecki, 128 S. Ct. 1147, 1156-57 (2008) (according
Skidmore deference to agency interpretive position that was
“reasonable,” “consistent with the statutory framework” and
consistently applied for 5 years). Accordingly, we find section
102.5(d) is authorized and is entitled to Skidmore deference.
Creekstone also challenges USDA’s interpretation of
section 104.1. Section 104.1 provides that “[n]o biological
product shall be brought into the United States unless a permit
has been issued for such product” by the Administrator. Id.
§ 104.1. Although section 104.1 does not expressly provide that
the Administrator can deny an import permit based on the
product’s intended use (in this case, sales to Creekstone), USDA
so interprets the regulation. We believe USDA’s interpretation
of section 104.1 is not inconsistent with the regulation and
 15

therefore entitled to deference. See, e.g., Thomas Jefferson
Univ. v. Shalala, 512 U.S. 504, 512 (1994) (“We must give
substantial deference to an agency’s interpretation of its own
regulations . . . unless it is plainly erroneous or inconsistent with
the regulation.” (quotation omitted)); Gardebring v. Jenkins, 485
U.S. 415, 430 (1988).
We are not persuaded by Creekstone’s arguments to the
contrary. Creekstone first invokes the expressio unius est
exclusio alterius canon of statutory construction to assert that
the omission of “use” from VSTA’s provisions precludes USDA
from promulgating a “use” regulation. With a statute like
VSTA, however, which contains broad language authorizing the
agency to promulgate regulations necessary to “carry out” the
statute, we believe the doctrine has minimal, if any, application.
See Cheney R.R. v. ICC, 902 F.2d 66, 69 (D.C. Cir. 1990)
(“Whatever its general force, we think [expressio unius] an
especially feeble helper in an administrative setting, where
Congress is presumed to have left to reasonable agency
discretion questions that it has not directly resolved.”); Tex.
Rural Legal Aid, Inc. v. Legal Servs. Corp., 940 F.2d 685, 694
(D.C. Cir. 1991) (“Whatever its usefulness in other
circumstances . . . this canon has little force in the administrative
setting.”); see also NLRB v. Beverly Enters.–Mass., 174 F.3d 13,
32 (1st Cir. 1999); Ragsdale v. Wolverine World Wide, Inc., 535
U.S. 81, 97, 102 (2002) (O’Connor, J., dissenting) (arguing that
“expressio unius ought to have somewhat reduced force in th[e]
context” of statute authorizing agency to “ ‘prescribe such
regulations as are necessary to carry out’ the Act” (quoting 29
U.S.C. § 2654)).
Nevertheless, Creekstone argues that section 154’s
“otherwise to carry out” language cannot support the “use”
regulations because, as previously noted, the “otherwise to carry
out” language was not added to section 154 until almost ten
 16

years after USDA first asserted the authority to regulate the
“use” of biological products. As the district court correctly
noted, however, the argument “cuts both ways.” 517 F. Supp.
2d at 13 n.6. Because section 102.5(d) was already in effect
when the Congress amended VSTA in 1985, it had the
opportunity to alter the regulation but did not do so. See Doris
Day Animal League v. Veneman, 315 F.3d 297, 300 (D.C. Cir.
2003) (“ ‘[W]hen Congress revisits a statute giving rise to a
longstanding administrative interpretation without pertinent
change, the congressional failure to revise or repeal the agency’s
interpretation is persuasive evidence that the interpretation is the
one intended by Congress.’ ” (quoting Commodity Futures
Trading Comm’n v. Schor, 478 U.S. 833, 846 (1986) (quotation
omitted))). But Creekstone asserts that the 1985 amendment
does not satisfy the requirements of the legislative reenactment
doctrine because the “application of the legislative reenacement
doctrine requires a showing of both congressional awareness and
express congressional approval of an administrative
interpretation if it is to be viewed as statutorily mandated.” Gen.
Am. Transp. Corp. v. ICC, 872 F.2d 1048, 1053 (D.C. Cir. 1989)
(quotation omitted). Even assuming the 1985 amendment does
not satisfy the legislative reenactment doctrine, however, the
Congress’s 1985 decision to leave section 102.5(d) undisturbed
is “persuasive evidence” that it is consistent with congressional
intent. See NLRB v. Bell Aerospace Co. Div. of Textron, Inc.,
416 U.S. 267, 274-75 (1974) (“[A] court may accord great
weight to the longstanding interpretation placed on a statute by
an agency charged with its administration.” (footnote
omitted)).10

10
Creekstone also argues that USDA’s “use” regulations
should be invalidated because USDA did not claim the authority
to regulate the use of biological products until 63 years after
 17

Creekstone also argues that VSTA’s legislative history
demonstrates that the Congress intended to regulate
manufacturers and importers of biological products, not users
like Creekstone. Creekstone cites the 1913 testimony of A.M.
Farrington, Assistant Chief of the Bureau of Animal Industry,
before the House Committee on Agriculture, to the effect that
VSTA was meant to allow USDA to regulate the preparation
and marketing of biological products. See Agriculture
Appropriation Bill: Hearings Before the Senate Comm. on
Agric., 62d Cong. 23-24 (1913) (testimony of A.M. Farrington,
Asst. Chief, Bureau of Animal Indus., USDA). We are not
persuaded. The legislative history of VSTA is “extremely
sparse,” Animal Health Inst. v. USDA, 487 F. Supp. 376, 378 (D.
Co. 1980), and the history that does exist does not conclusively
support either interpretation. See, e.g., S. Rep. No. 62-1288, at
2 (1913) (VSTA is intended “to control[] use[] by preventing the
interstate shipment[] of dangerous drugs.” (emphasis added)).
In any event, whether a “use” regulation was contemplated by
the Congress in 1913, we believe the Congress subsequently
endorsed the same in 1985.
Finally, Creekstone argues that the Agricultural

VSTA was enacted. We do not agree. “To be sure, agency
interpretations that are of long standing come before us with a
certain credential of reasonableness, since it is rare that error
would long persist. But neither antiquity nor contemporaneity
with the statute is a condition of validity.” Smiley v. Citibank,
517 U.S. 735, 740 (1996) (sustaining Comptroller of the
Currency’s 1996 regulation promulgated more than 130 years
after governing statute—National Bank Act of 1864—was
enacted).
 18

Bioterrorism Protection Act of 2002 (ABPA)11 supports its claim
that VSTA does not authorize a “use” regulation. ABPA gives
the Secretary authority to regulate “each biological agent and
each toxin that [he] determines has the potential to pose a severe
threat to animal or plant health.” 7 U.S.C. § 8401(a)(1)(A). The
House Conference Report accompanying ABPA noted that the
legislation was needed, in part, because of “the inadequacy of
the penalty provisions of [VSTA]—enacted in 1913 and under
which USDA currently regulates these dangerous agents—as
well as the lack of authority for the Secretary of Agriculture to
regulate possession of biological agents and toxins that pose a
severe threat to plant or animal health.” H.R. Rep. No. 107-481,
at 124 (2002) (Conf. Rep.) (emphasis added). According to
Creekstone, the Report shows the Congress did not believe that
VSTA gives USDA the authority to regulate the use of
biological products. We disagree. First, ABPA governs only
those substances that “pose a severe threat to plant or animal
health.” VSTA, by contrast, encompasses all biological
products intended “for use in the treatment of domestic
animals.” 21 U.S.C. §§ 151, 152. Further, the Congress
effectively refuted Creekstone’s interpretation by specifically
exempting from ABPA products already regulated under VSTA.
See 7 U.S.C. § 8401(g)(1)(C).
2. USDA’s regulation of diagnostic testing
In Count I Creekstone also argues that USDA lacks the
authority to regulate diagnostic testing in general because it is
not used in the “treatment” of domestic animals as treatment was

11
ABPA is part of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, Pub. L.
No. 107-188, §§ 211-13, 116 Stat. 594, 647 (codified at 7 U.S.C.
§ 8401).
 19

defined in 1913. See Compl. ¶ 31; 517 F. Supp. 2d at 12.
According to Creekstone, in 1913, “ ‘treat’ was defined, inter
alia, as: ‘[t]o care for medicinally or surgically; to manage in the
use of remedies or appliances; as, to treat a disease, a wound, or
a patient.’ ” Creekstone Br. 27 (citing Webster’s Revised
Unabridged Dictionary (1913 ed.)). USDA’s regulation,
however, defines “treatment” as “the prevention, diagnosis,
management, or cure of diseases of animals.” 9 C.F.R. § 101.2
(emphasis added). We see no reason to disturb USDA’s
definition as set forth in section 101.2. Indeed, Creekstone
acknowledges that “[t]he word ‘treatment’ does not have a
precise meaning and is not a legal term of art.” Creekstone Br.
27. And we owe USDA a considerable degree of deference in
its interpretation of the term, bearing, as it does, on USDA’s
charge to “administer[] our federal meat and poultry inspection
laws.” Am. Fed’n of Gov’t Employees, 284 F.3d at 129
(applying Skidmore); see Troy Corp. v. Browner, 120 F.3d 277,
283 (D.C. Cir. 1997) (“[W]e review scientific judgments of the
agency ‘not as the chemist, biologist, or statistician . . . , but as
a reviewing court exercising our narrowly defined duty of
holding agencies to certain minimal standards of rationality.’ ”
(quoting Ethyl Corp. v. EPA, 541 F.2d 1, 36 (D.C. Cir. 1976))).
Given the “degree of deference” we owe USDA, we uphold its
definition of “treatment” as including diagnosis and therefore its
authority to regulate BSE testing for the purpose of diagnosis.
B. Count II
In Count II, Creekstone challenges USDA’s regulation of
the rapid BSE test kit because, again, it is not used in the
“treatment” of domestic animals. Compl. ¶¶ 40. The district
court agreed, reasoning that “[e]ven if USDA is correct that
diagnosis in general is an inherent and crucial aspect of
treatment,” USDA cannot consider BSE testing diagnostic
because “[t]here is no known treatment or cure for BSE . . . and
 20

BSE test kits are used only on animals that are dead.” 517 F.
Supp. 2d at 16 (citation omitted) (emphasis in original). We
disagree. As already noted, section 101.2 defines “treatment” as
“the prevention, diagnosis, management, or cure of diseases of
animals.” 9 C.F.R. § 101.2 (emphasis added). Thus, in order to
satisfy the definition, the rapid BSE test kit need fulfill only one
of the functions. Plainly, rapid BSE testing is used to diagnose
the disease. Moreover, rapid BSE testing plays a valuable role
in preventing and managing the spread of BSE. It allows USDA
to identify and destroy the remains of an infected cow, trace the
spread of the disease and evaluate the success of its disease
management measures (e.g., the ruminant feed ban). Thus,
while there is no way to “treat” or cure the dead cow if the test
is positive, the test kit nonetheless plays an important diagnostic
role. Accordingly, we are persuaded by USDA’s reasonable
reading of “diagnosis” to include rapid BSE testing.
Creekstone counters that USDA’s position here is
inconsistent with its earlier statements about BSE testing. It
claims that USDA acknowledged in a 2005 rulemaking that BSE
testing of cattle at slaughter is not “meaningful in the context
of . . . animal health” and that surveillance testing for BSE “is
not a [disease] mitigation measure.” Importation of Whole Cuts
of Boneless Beef from Japan, 70 Fed. Reg. 73,905, 73,914 (Dec.
14, 2005). The statement comes from a USDA rulemaking
setting forth various conditions for importing Japanese beef into
the United States. Id. In response to a comment urging “a
mandatory [BSE] testing requirement” for all Japanese imports,
USDA declared that it “d[id] not consider the testing of bovines
at slaughter to be scientifically justified or meaningful in the
context of either human or animal health.” Id. USDA explained
that universal testing is not “meaningful” because, given BSE’s
long incubation period and the relatively young age of most
cattle at slaughter, it would not produce meaningful results. Id.
 21

We read USDA’s comment that BSE testing is “not meaningful
in the context . . . of animal health” to refer only to blanket BSE
testing and not to the efficacy of BSE testing when used on
high-risk cattle only. We also read USDA’s comment that
“surveillance is not a [disease] mitigation measure” to refer only
to universal testing. See id. (noting “[a] statistically and
epidemiologically valid surveillance plan is crucial to
monitoring the success of risk mitigation measures.” (emphasis
added)).12 Indeed, USDA permits “targeted” BSE testing in
approved laboratories as part of its BSE surveillance program.
See 70 Fed. Reg. at 475 (“The purpose of a surveillance program
is to gauge the level of BSE prevalence. This can be achieved
through targeted sampling . . . .”).
To sum up, we conclude that section 102.5(d), 9 C.F.R.
§ 102.5(d), which allows USDA to impose “restrictions on the
use” of a biological product, including “limits on . . .
distribution,” is valid; that under section 104.1, 9 C.F.R. § 104.1,
USDA can restrict the importation of a “biological product” by
limiting its sale to certain users; that USDA’s definition of
“treatment” set forth in 9 C.F.R. § 101.2(3) is reasonable; and
that USDA can regulate the use of the rapid BSE test kit by,
inter alia, restricting its distribution and sale. Count III of
Creekstone’s complaint is not before us and therefore we do not
reach it.
For the foregoing reasons, the district court’s grant of
summary judgment to USDA on Count I is affirmed, its grant of

12
Creekstone also highlights a comment from a USDA
publication stating that “BSE has no cure or treatment.” See
Economic Chronology 3. USDA’s observation regarding BSE
contained in a document that carries no force of law does not
affect USDA’s authority to regulate BSE testing.
 22

summary judgment to Creekstone on Count II is reversed and
the case is remanded for further proceedings consistent with this
opinion.
So ordered.
 ROGERS, Circuit Judge, concurring: I join in affirming the
grant of summary judgment to the Agriculture Department and
reversing the grant of summary judgment to Creekstone Farms.
However, I do so on the ground that the Department’s
interpretation of 9 C.F.R. § 104.1, as allowing it to restrict
import permits based on intended use of a biological product, is
entitled to deference, see Chevron U.S.A., Inc. v. Natural Res.
Def. Council, Inc., 467 U.S. 837 (1984); Op. at 15; 21 U.S.C. §
152.1 See Op. at 4, 14-15. Because the Department exercised
this authority to prevent the importation of BSE test kits on
behalf of Creekstone Farms, see Op. at 8-9 & nn.4, 6, and the
Department’s definition of treatment, 9 C.F.R. § 101.2(3), is
reasonable, Op. at 20-21, there is no need for the court to opine
on unrelated aspects of the Department’s regulations
implementing the Virus-Serum-Toxin Act, 21 U.S.C. §§ 151-59;
cf. Stanton v. D.C. Court of Appeals, 127 F.3d 72, 74 (D.C. Cir.
1997).

1
Our dissenting colleague does not address this regulation or
21 U.S.C. § 152.
 SENTELLE, Chief Judge, dissenting: Though I respect my
colleagues’ careful analysis of the application of the Chevron
doctrine to the governing statutes in this case, in my view the
Department of Agriculture’s interpretation of those statutes does
not survive Chevron Step 2. I will grant the existence of some
ambiguity (no doubt intended by Congress) in the Virus-Serum-
Toxin Act, 21 U.S.C. §§ 151-159 (2007) (“VSTA”). I think,
however, that the Department exceeds the bounds of
reasonableness in the interpretation assumed in its regulations.
In its interpretation of the terms within the statute, as well as its
understanding of the power afforded by the statute, the
Department has gone as far as it could and, in my view, farther
than it reasonably could in aggregating power to itself.

First, the VSTA covers “any . . . virus, serum, toxin, or
analogous product . . . .” 21 U.S.C. § 151 (emphasis added).
Nothing in the Department’s regulations or its filings in the
district court suggests an analogy between the test kits at issue
and the viruses, sera, or toxins covered by the statute. Further,
I find unpersuasive the Department’s arguments that a product
with no other use than the diagnosis of an untreatable and
invariably fatal disease is a form of “treatment.”

Finally, I find myself unable to join the conclusion in Judge
Henderson’s opinion that the language in § 154 empowering the
Department of Agriculture to “otherwise . . . carry out” the goals
of the statute includes the authority to regulate the “use” of
biological products. While it is true that the “expressio unius est
exclusio alterius” canon of statutory construction is applied with
muted force in “the administrative setting,” Maj. Op. at 15
(quoting Texas Rural Legal Aid, Inc. v. Legal Services Corp.,
940 F.2d 685, 694 (D.C. Cir. 1991)), the concept does not go
away, even in the administrative setting. As we have often held,
congressional provision of an expressed authority mandate to
accomplish statutory goals “does not create for the agency ‘a
roving commission’ to achieve those or ‘any other laudable
 2

goal,’” BP West Coast Products, LLC v. FERC, 374 F.3d 1263,
1293 (D.C. Cir. 2004) (quoting Michigan v. EPA, 268 F.3d
1075, 1084 (D.C. Cir. 2001)), by means beyond the authority
granted in the statute. I therefore would accept Creekstone’s
argument that the “otherwise to carry out” language of § 154
cannot support the “use” regulations.

In short, I would affirm the district court’s grant of
summary judgment on Count II and reverse its denial on Count
I. I would further note that Count III of this action will return to
the district court for application of the arbitrary and capricious
standard. It seems that the Department’s fear is that
Creekstone’s use of the test kits would enable it to provide
buyers with a false assurance that the cattle from which its beef
is obtained are free of Bovine Spongiform Encephalopathy.
However, as I read the record, all Creekstone hopes to do is
assure foreign buyers that the beef is as well-tested as would be
the case with beef produced in the home countries of those
buyers. I will be interested in learning later whether this
interdiction by the Department can survive the arbitrary and
capricious test that will govern the district court’s review of that
additional count.