Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-07-05199/USCOURTS-caDC-07-05199-0/pdf.json

Nature of Suit Code: 891
Nature of Suit: Agricultural Acts
Cause of Action: 

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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.

USCA Case #07-5199 Document #1135720 Filed: 08/29/2008 Page 1 of 25
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Russell S. Frye argued the cause for the appellee/crossappellant. 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.

USCA Case #07-5199 Document #1135720 Filed: 08/29/2008 Page 2 of 25
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1

Any violation of VSTA is a misdemeanor “punish[able] by

a fine of not exceeding $1,000 or by imprisonment not

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

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4

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).

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

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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.

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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

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,

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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.

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

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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.

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 USDAapproved 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

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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).

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

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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.

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

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8

We use the term “use” regulations to refer to 9 C.F.R.

§§ 102.5(d) and 104.1.

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,

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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).

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

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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

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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

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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

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10Creekstone 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

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

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17

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).

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

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11ABPA 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).

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

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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

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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.

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12Creekstone 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.

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

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22

summary judgment to Creekstone on Count II is reversed and

the case is remanded for further proceedings consistent with this

opinion.

So ordered.

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1

 Our dissenting colleague does not address this regulation or

21 U.S.C. § 152.

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).

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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-SerumToxin 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

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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.

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