FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

RANCHERS CATTLEMEN ACTION 

LEGAL FUND UNITED

STOCKGROWERS OF AMERICA,

Plaintiff-Appellee, No. 05-35264

v. D.C. No.

UNITED STATES DEPARTMENT OF  CV 05-006 RFC

AGRICULTURE, Animal and Plant OPINION Health Inspection Service; MIKE

JOHANNS, in his capacity as the

Secretary of Agriculture,

Defendants-Appellants. 

Appeal from the United States District Court

for the District of Montana

Richard F. Cebull, District Judge, Presiding

Argued and Submitted

July 13, 2005—Seattle, Washington

Filed July 25, 2005

Before: A. Wallace Tashima, Richard A. Paez, and

Consuelo M. Callahan, Circuit Judges.

Opinion by Judge Tashima

8731
COUNSEL

Mark B. Stern, Civil Division, U.S. Department of Justice,

Washington, DC, for the defendants-appellants. 

Russell S. Frye, Frye Law PLLC, Washington, DC, for the

plaintiff-appellee. 

Maureen E. Mahoney, Latham & Watkins LLP, Washington,

DC, for amicus curiae Government of Canada. 

Gregory G. Garre, Hogan & Hartson LLP, Washington, DC,

for amici curiae National Cattlemen’s Beef Association,

American Farm Bureau Federation, National Pork Producers

Council, 29 State Cattlemen’s Associations, 18 State Farm

Bureaus, and 9 Individual Cattle Producers. 

Sarah Weinstein, Mayer, Brown, Rowe & Maw LLP, Palo

Alto, California, for amicus curiae Alberta Beef Producers. 

Michael B. Gillett, McElroy Law Firm, PLLC, Seattle, Washington, for amicus curiae Easterday Ranches, Inc. 

Joseph O. Click, Blank Rome LLP, Washington, DC, for

amici curiae Canadian Cattlemen’s Association and Its Affiliated Organizations. 

Jonathan L. Abram, Hogan & Hartson, Washington, DC, for

amici curiae American Meat Institute, North American Meat

Processors, Southwestern Meat Association, Eastern Meat

RANCHERS CATTLEMEN v. USDA 8735
Packers Association, American Association of Meat Processors, National Restaurant Association, and United Food and

Commercial Workers. 

John O’Brien, Kerr Brosseau Bartlett O’Brien, LLC, Denver,

Colorado, for amicus curiae Pioneer, Inc. 

Gregg Spyridon, Spyridon, Koch, Palermo, & Dornan, LLC,

Metairie, Louisiana, for amici curiae the Camelid Alliance, et

al. Alan Charles Raul, Sidley Austin Brown & Wood LLP,

Washington, DC, for amicus curiae Tyson Foods, Inc. 

David A. Domina, Domina Law pc llo, Omaha, Nebraska, for

amici curiae 67 National, State, and Local Consumer and

Research Groups, Public Interest Organizations, Farm and

Ranch Organizations, and Local and Private Organizations. 

Christian D. Tweeten, Chief Civil Counsel, Montana Attorney

General, Helena, Montana, for amici curiae States of Montana, Connecticut, Nevada, New Mexico, North Dakota, and

South Dakota. 

OPINION

TASHIMA, Circuit Judge: 

We must decide whether the district court erred in issuing

a preliminary injunction prohibiting the implementation of a

regulation of the United States Department of Agriculture

(“USDA”) permitting the resumption of the importation of

Canadian cattle into the United States. We conclude that it did

and therefore reverse the district court. 

At the heart of this case lies a relatively new cattle disease

caused by the practice of feeding cows, herbivores by nature,

the brains and other central nervous system tissues of other

8736 RANCHERS CATTLEMEN v. USDA
cows. Technically known as Bovine Spongiform Encephalopathy (“BSE”), this disease, popularly known as mad cow disease, has spread from farms in England to 25 countries around

the world since its discovery in 1986. 

As BSE spread throughout the globe during the past 20

years, USDA instituted a policy of barring the importation of

ruminants1 and ruminant products from countries where BSE

was known to exist. In a final rule entitled Bovine Spongiform

Encephalopathy: Minimal Risk Regions and Importation of

Commodities; Final Rule and Notice, 70 Fed. Reg. 460 (Jan.

4, 2005) (the “Final Rule”), USDA relaxed this longstanding

practice, allowing limited ruminant imports from Canada,

despite the fact that two cases of BSE had been found in Canada at the time. 

Plaintiff-Appellee, Ranchers Cattlemen Action Legal Fund

United Stockgrowers of America (“R-CALF”), successfully

blocked the implementation of the Final Rule, convincing the

court below to find the rule arbitrary and capricious under the

Administrative Procedure Act (“APA”), 5 U.S.C. § 706(2),

and to issue a preliminary injunction prohibiting its enforcement. See Ranchers Cattlemen Action Legal Fund United

Stockgrowers of Am. v. United States Dep’t of Agric., 359 F.

Supp. 2d 1058 (D. Mont. 2005) (“R-CALF I”). Because we

conclude that the district court applied an incorrect legal standard, we reverse.2

1Ruminants are hoofed mammals generally defined by their fourchambered stomachs and their practice of chewing a cud consisting of

regurgitated, partially digested food. Ruminants include cattle, sheep,

goats, deer, giraffes, camels, llamas, and okapi, among others. 

2On July 14, 2005, after the completion of briefing and oral argument

we issued a stay of the preliminary injunction pending the resolution of

this appeal. See Fed. R. App. P. 8(a). 

RANCHERS CATTLEMEN v. USDA 8737
I. FACTUAL AND PROCEDURAL BACKGROUND

A. Bovine Spongiform Encephalopathy

BSE was first diagnosed in England in the late 1980s. This

new disease spread rapidly, infecting thousands of English

cattle and eventually reaching countries all over the globe.

Although the disease has since been largely contained, it continues to persist, and it resides at the center of the current lawsuit. 

BSE is a species of Transmissible Spongiform Encephalopathy (“TSE”), a family of degenerative neurological diseases

that affects a wide range of animals, including sheep, goats,

and deer, as well as humans. Although there remains some

dispute, it is widely believed that BSE and other TSEs are

caused by prions, abnormally shaped and extremely hardy

proteins that were only recently discovered. 

TSEs have a debilitating neurological impact on their victims. After an incubation period of months or years, the diseases create myriad tiny holes in the brain, slowly

deteriorating their victims’ mental and physical abilities until

death eventually results. In cattle, BSE has an incubation

period of two to eight years, during which time the infected

animal shows no outward sign of the illness. Once the disease

progresses, however, infected cattle begin showing symptoms

within two to three months. These symptoms can include nervousness or aggression, abnormal posture, impaired coordination, decreased milk production, and loss of body condition

despite continued appetite. 

At the height of the BSE epidemic in the United Kingdom,

tens of thousands of cattle were confirmed to have the disease, and by some estimates the number of infected cattle in

the United Kingdom may have reached into the millions. All

told, there have been more than 187,000 confirmed cases of

8738 RANCHERS CATTLEMEN v. USDA
BSE in cattle worldwide, over 95 percent of which have

occurred in the United Kingdom. 

Epidemiological investigations in England quickly determined that BSE was likely spread through cattle feed that was

infected with the BSE agent. The blame for the contaminated

feed fell squarely on the practice, common in Europe at the

time, of creating high-protein cattle feed through the “recycling” of otherwise unusable cattle parts. This process is

known as “rendering,” and involves placing animal protein in

large tanks and cooking at temperatures high enough to kill

most microorganisms.3 Although the rendering process is able

to eliminate most bacterial and viral diseases, the BSE agent

is resistant enough to heat and other sterilization processes to

withstand the conversion into feed. Infected tissue from a single infected cow, when rendered into cattle feed, could therefore be fed to hundreds of cattle, exposing them all to the

possibility of infection. 

Several years after the discovery of BSE, the disease

became a matter of much more serious concern. In 1996, the

British government announced that a new form of TSE in

humans, variant Creutzfeldt-Jakob Disease (“vCJD”), was

likely caused by human consumption of cattle products that

were contaminated with the BSE agent. To date, only approx3Rendering continues to this day in the United States, where approximately 50 billion pounds of tissue from dead animals are converted into

animal feed each year. The breadth of the practice at one Baltimore rendering facility has been reported to include: 

Bozeman, the Baltimore City Police Department quarter horse

who died last summer in the line of duty. . . . A baby circus elephant who died while in Baltimore this summer. Millions of tons

of waste meat and inedible animal parts from the region’s supermarkets and slaughterhouses. Carcasses from the Baltimore zoo.

The thousands of dead dogs, cats, raccoons, possums, deer, foxes,

snakes, and the rest that local animal shelters and road-kill patrols

must dispose of each month. 

Van Smith, What’s Cookin?, Baltimore City Paper, Sept. 27, 1995. 

RANCHERS CATTLEMEN v. USDA 8739
imately 150 cases of vCJD have been identified worldwide,

the vast majority of which occurred in England during the

height of its BSE epidemic. Although vCJD has been diagnosed in two people in North America, in both cases the disease is believed to have been contracted in England; no case

of vCJD has ever been linked to North American beef.4

Because BSE is a relatively new disease, and because

prions are a relatively recent scientific discovery, the state of

knowledge surrounding BSE is somewhat incomplete. Efforts

to understand the disease fully have been hampered because

current testing methodology is not particularly effective in

identifying it. No live animal test for BSE exists, meaning that

cows must be slaughtered before they can be tested. In addition, the tests that do exist are unable to detect the disease

during the vast majority of the time a cow is infected. The

earliest point at which current tests can detect the disease is

two to three months before an animal starts showing clinical

signs of infection. BSE has an incubation period that lasts for

four to five years on average, however, during which the animal carries the disease but shows no outward symptoms. 

Given these testing limitations, there remain a number of

open public health questions surrounding BSE, in particular

concerning the means through which the disease can be transmitted. The only documented method of BSE transmission is

through the consumption of feed contaminated with the BSE

agent. Some research involving both BSE and other TSEs,

however, suggests that BSE may be transmitted through

means other than contaminated feed. For example, in experiments on sheep, mice, and hamsters, both BSE and scrapie, a

TSE disease that affects sheep, were transmitted through

4The single known case of vCJD in the United States occurred in a Florida woman who was born in England in 1979. It is believed she was

exposed to BSE before she moved to the United States in 1992. Similarly,

the single case of vCJD in Canada occurred in a man who had stayed in

the United Kingdom on multiple trips. 

8740 RANCHERS CATTLEMEN v. USDA
whole blood transfusion. At least one case of vCJD is also

believed to have been transmitted through human blood transfusion. Other studies have suggested that prions can be

exchanged through saliva, while still others suggest that BSE

may be transmitted maternally. 

Despite the highly infectious nature of the BSE agent, evidence suggests that meat from cows infected with BSE may

be safely consumed by humans because BSE does not occur

in all parts of its host. Specifically, the BSE agent appears not

to exist in muscle tissue of cattle. Rather, the disease is generally confined to the central nervous system — the brain, spinal cord, eyes, dorsal root ganglia, and trigeminal ganglia5

 —

although it has also been found in the tonsils and distal ilium,

a part of the small intestine, of cattle. Research on other TSEs,

however, calls into question whether the BSE agent is truly

limited to these tissues. Specifically, some research has suggested that sheep infected with scrapie may have prions in

their muscle tissue. 

Despite the fact that it has only been known to exist for 20

years, the geographic range of BSE is substantial. From

England, it has spread to cattle in most of Europe, as well as

in the Middle East, Japan, and Canada. 9 C.F.R. § 94.18(a)(1)

(2003). As of the date of the district court’s opinion, however,

BSE had never occurred in a cow native to the United States.

That changed on June 24, 2005, when the Secretary of Agriculture announced that a cow in Texas had tested positive for

BSE. Statement by Dr. John Clifford Regarding the Epidemiological Investigation into the recently confirmed BSE case

(June 29, 2005), available at http://www.aphis.usda.gov/lpa/

issues/bse/bse.html. A subsequent investigation revealed that

the cow was born in the United States approximately 12 years

ago. 

5Trigeminal ganglia are clusters of nerve cells connected to the brain

that lie close to the exterior of the skull. Dorsal root ganglia are clusters

of nerve cells attached to the spinal cord and contained within the bones

of the vertebral column. 

RANCHERS CATTLEMEN v. USDA 8741
B. United States Regulation of BSE

The federal government has implemented a number of

safety measures to minimize the threat of BSE to U.S. citizens

and livestock. These precautions consist of an interlocking

regulatory framework overseen by three different federal

agencies. First and foremost, since 1997, the Food and Drug

Administration (“FDA”) has overseen a feed ban that prohibits the feeding of ruminant protein to other ruminants. See 21

C.F.R. § 589.2000 (2005). Such feed bans are generally the

first line of defense against the spread of BSE, and they have

been highly effective in other countries. The prevalence of

BSE in the United Kingdom, for example, dropped drastically

after it implemented its feed ban. 

Critics, however, question whether the FDA feed ban is

truly effective. See, e.g., Thomas O. McGarity, Federal Regulation of Mad Cow Disease Risks, 57 Admin. L. Rev. 289,

307 (2005). Given the highly infectious and resilient nature of

the BSE agent, these critics argue that the FDA feed ban has

“gaps” that could result in the use of feed derived from rendered cattle protein as feed for cattle. For example, cattle are

allowed to be fed human “plate waste” from establishments

such as amusement parks, despite the fact that this plate waste

may contain beef products. In addition, the feed ban allows

rendered cattle protein to be fed to non-ruminants, such as

pigs and chickens. Thus, BSE could be spread through mislabeled feed or through misfeeding on a farm. Finally, waste

from the floor of chicken coops is commonly scooped up and

fed to cattle; uneaten chicken feed or chicken droppings that

contain the BSE agent could therefore be fed to cattle via this

procedure. 

An agency within USDA, Food Safety and Inspection Services (“FSIS”), oversees a second line of defense against

BSE. FSIS promulgates regulations to ensure that the nation’s

food supply of meat, eggs, and poultry is safe. See http://

www.fsis.usda.gov/About_FSIS/index.asp. These regulations

8742 RANCHERS CATTLEMEN v. USDA
restrict certain cattle parts from being incorporated into the

human food supply. For example, FSIS regulations prohibit

the use of “downer” cattle6 as human food because inability

to stand is a common BSE symptom. 9 C.F.R. § 309.2 (2005).

FSIS regulations also prohibit those cattle parts that have

demonstrated BSE infectivity, known as specified risk materials (“SRMs”), from being used in human food.7

 9 C.F.R.

§ 310.22 (2005). Finally, FSIS regulations prohibit certain

methods of slaughter and butchering thought to increase the

risk of contaminating meat with central nervous system tissues.8

6Non-ambulatory or “downer” cattle are cattle that “cannot rise from a

recumbent position or that cannot walk.” 9 C.F.R. § 309.2(b) (2005). FSIS

banned these cattle from the human food supply because “surveillance

data from European countries in which BSE has been detected indicate

that non-ambulatory cattle are among the animals that have a greater incidence of BSE than other cattle.” Prohibition of the Use of Specified Risk

Materials and Requirements for the Disposition of Non-Ambulatory Disabled Cattle, 69 Fed. Reg. 1862, 1862 (January 12, 2004) (“FSIS SRM

Rule”). 

7Because BSE infectivity spreads as a cow ages, current regulations

define only the distal ilium and tonsils of all cattle to be SRMs. 9 C.F.R.

§ 310.22(a) (2005). The brain, spinal cord, and other central nervous system components are only considered to be SRMs in cattle of 30 months

of age and older. Id.

8Specifically, FSIS regulations prohibit the use of “air-injection captive

bolt stunning,” a process through which a metal bolt and compressed air

are driven into the cranium of cattle, because the practice poses a risk of

contaminating edible meat with central nervous system tissue. See 9

C.F.R. § 310.13(a)(2)(iv)(C) (2005). The regulations also prohibit the use

of “Advanced Meat Recovery” systems and the labeling of “mechanically

separated beef” as meat. See FSIS SRM Rule, 69 Fed. Reg. at 1866. The

former “is a technology that enables processors to remove the attached

skeletal muscle tissue from livestock bones without incorporating a significant amount of bone or bone product into the final meat product.” Id.; see

also Meat Produced by Advanced Meat/Bone Separation Machinery and

Meat Recovery (AMR) Systems, 69 Fed. Reg. 1874, 1876 (Jan. 12, 2004).

The latter “is a paste-like and batter-like meat product produced by forcing

[beef] bones with attached edible meat under high pressure through a

sieve.” See http://www.fsis.usda.gov/oa/pubs/lablterm.htm. 

RANCHERS CATTLEMEN v. USDA 8743
Another branch of USDA, Animal and Plant Health Inspection Services (“APHIS”), provides the final link in the regulatory framework. APHIS promulgates regulations designed to

protect the United States from the introduction of BSE from

other countries. To achieve this goal, until the Final Rule was

promulgated, APHIS banned the importation of all ruminants

and ruminant products from countries where BSE was known

to exist. See 9 C.F.R. §§ 93.401, 94.18 (2003). 

APHIS has also been actively involved in the development

of international guidelines to fight the spread of BSE. In this

role, APHIS works with the Office International des Epizooties (“OIE”), the organization recognized by the World Trade

Organization as responsible for the development and periodic

review of standards, guidelines, and recommendations with

respect to animal health and “zoonoses” (diseases that are

transmissible from animals to humans).

C. Factual Background

Early this year, APHIS announced its decision to relax its

ban on the importation of ruminants and ruminant products

from countries where BSE was known to exist. The genesis

of this policy change occurred on May 20, 2003, when a cow

in Alberta was diagnosed with BSE. This represented not only

the first case of BSE native to North America, but it wreaked

havoc on the highly integrated beef market that exists

between the United States and Canada. Shortly after the

infected cow was announced, then Secretary of Agriculture

Veneman issued an Emergency Order adding Canada to the

list of regions where BSE was known to exist. Change in Disease Status of Canada Because of BSE, 68 Fed. Reg. 31,939

(May 29, 2003). Under the regulations then in effect, all

imports of live ruminants or ruminant meat products from

Canada were prohibited. See 9 C.F.R. §§ 93.401, 94.18

(2003). 

Beginning in August 2003, the Secretary incrementally

began moving to reopen the border to Canadian ruminants

8744 RANCHERS CATTLEMEN v. USDA
and ruminant products and to reestablish the voluminous

North American beef trade. On August 8, 2003, the Secretary

announced that she would begin allowing certain “low-risk”

ruminant products to be imported into the United States from

Canada, the most significant of which was “[b]oneless bovine

meat from cattle under 30 months of age.” See Final Rule, 70

Fed. Reg. at 536; USDA News Release No. 0281.03 (Aug. 8,

2003), available at http://www.usda.gov/wps/portal. 

On November 4, 2003, the Secretary published notice of a

proposed rule, seeking to amend the regulations governing the

importation of ruminants from countries where BSE is known

to exist. Bovine Spongiform Encephalopathy; Minimal Risk

Regions and Importation of Commodities, 68 Fed. Reg.

62,386 (Nov. 4, 2003). The proposed rule would have allowed

the importation of ruminants from countries in a newly created category — “regions that present a minimal risk of introducing [BSE] into the United States via live ruminants and

ruminant products.” Id. The new regulation proposed to designate only Canada as a minimal-risk region. Id. The comment

period for the proposed rule was set to expire on January 5,

2004. Id.

A month and a half after the Secretary published the notice

of proposed rule, on December 23, 2003, a cow in Washington State was diagnosed with BSE. Bovine Spongiform

Encephalopathy; Minimal Risk Regions and Importation of

Commodities, 69 Fed. Reg. 10,633 (Mar. 8, 2004). An investigation revealed that the cow was born in Canada and was

imported into the United States in 2001. Id. at 10,634. Given

that the cow was born before Canada’s feed ban went into

effect in 1997, USDA determined that the likeliest cause of its

BSE infection was contaminated feed. Id. Nevertheless, in

response to this discovery USDA reopened the comment

period for its proposed rule for an additional 30 days, extending it until April 7, 2004. Id. at 10,633. 

RANCHERS CATTLEMEN v. USDA 8745
On April 19, 2004, USDA moved, without public notice, to

expand the types of ruminant products eligible to be imported

from Canada.9 Ranchers Cattlemen Action Legal Fund United

Stockgrowers of Am. v. United States Dep’t of Agric., 2004

WL 1047837 (D. Mont. 2004) (“R-CALF TRO”). R-CALF

sued to prevent this move, and the district court granted a

temporary restraining order on April 26, 2004, barring the

Secretary from proceeding with that plan. Id.

On January 4, 2005, USDA published its Final Rule. The

agency, after having considered 3,379 comments from interested parties, proceeded with its plan to reopen the border to

Canadian ruminants and ruminant products. Final Rule, 70

Fed. Reg. at 460, 469. Among other provisions, the Final Rule

allowed the importation of Canadian cattle under 30 months

of age provided the cattle were immediately slaughtered or

fed and then slaughtered.10 Id. at 548. The Final Rule also permitted the importation of beef products from Canadian cattle

of all ages. Id. at 461, 465. The rule was scheduled to go into

effect on March 7, 2005. Id. at 460. 

9Specifically, USDA issued a memorandum stating that, effective April

19, 2004, all existing permits to import meat from Canada “will be

deemed to cover all edible bovine meat products (bone-in, boneless,

ground meat, further processed),” provided each shipment is accompanied

by a statement that the meat was processed in “establishments that are certified to FSIS as eligible for export to the United States.” R-CALF TRO,

2004 WL 1047837 at *2. USDA also published a table identifying “Low

Risk Canadian Products.” That table included “boneless, bone-in, ground

meat, and further processed bovine meat products,” bovine tongue, bovine

hearts, kidneys, and tripe, and bovine lips.” Id.

10According to amicus Pioneer, Inc., a family-owned feedlot, the cattle

industry is generally comprised of three parts: ranchers, who breed cattle

and grow them until they reach approximately 650 pounds; feedlots,

which purchase cattle from ranchers and feed them high protein feed until

they reach approximately 1,150 pounds; and meat packers, which purchase cattle from feedlots and process them for human consumption. Thus,

the Final Rule allowed Canadian cattle either to be sold to a feedlot for

feeding or to be sold directly to a meat packing company for slaughter. 

8746 RANCHERS CATTLEMEN v. USDA
At roughly the same time that USDA published its Final

Rule, two additional cases of BSE were confirmed in Alberta

— one on January 2, 2005, and another on January 11. Bovine

Spongiform Encephalopathy; Minimal Risk Regions and

Importation of Commodities; Finding of No Significant

Impact and Affirmation of Final Rule, 70 Fed. Reg. 18,252,

18,254 (Apr. 8, 2005). One of these cows, like the two previous Canadian cattle diagnosed with BSE, was born before

Canada’s feed ban; the other, however, was born shortly

thereafter. Id. at 18,258. Once again, USDA attributed the

infections in both cows to contaminated feed manufactured

before Canada’s feed ban went into effect. Id. at 18,255.

Nonetheless, USDA indefinitely suspended the implementation of the portion of its Final Rule that permitted the importation of beef products from cattle over 30 months of age.11

Bovine Spongiform Encephalopathy; Minimal Risk Regions

and Importation of Commodities; Partial Delay of Applicability, 70 Fed. Reg. 12,112 (Mar. 11, 2005). 

D. Procedural History

Six days after USDA published the Final Rule, R-CALF

filed this action, seeking to enjoin the rule’s implementation.12

In its complaint, R-CALF alleged that USDA’s rulemaking

violated the Administrative Procedure Act (“APA”), the Regulatory Flexibility Act (“RFA”), and the National Environmental Policy Act (“NEPA”). On February 1, 2005, three

weeks after filing its complaint, R-CALF filed its application

for a preliminary injunction to enjoin the Final Rule pendente

lite. 

11As mentioned above, an additional cow in the United States tested

positive for BSE on June 24, 2005. Because this cow was approximately

12 years old, USDA has attributed its infection to contaminated feed it

was exposed to before the U.S. feed ban came into effect. 

12R-CALF describes itself as a non-profit cattle association that represents U.S. “cattle producers, cattle backgrounders, and independent feedlot

owners” on issues concerning international trade and marketing. 

RANCHERS CATTLEMEN v. USDA 8747
On March 2, 2005, the district court issued a preliminary

injunction, barring USDA from implementing its Final Rule.

See R-CALF I, 359 F. Supp. 2d at 1074. The district court’s

primary reason for enjoining the Final Rule was its finding

that the rule was arbitrary and capricious in violation of the

APA. Id. at 1063-69; see also 5 U.S.C. § 706(2). The district

court’s overarching concern was that USDA, “ignoring its

statutory mandate to protect the health and welfare of the people of the United States, established its goal of re-opening the

border to the importation of live beef from Canada and thereafter attempted to work backwards to support and justify this

goal.” R-CALF I, 359 F. Supp. 2d at 1066. Given the agency’s

“preconceived intention, based upon inappropriate considerations, to rush to reopen the border regardless of uncertainties

in the agency’s knowledge,” the district court found the Final

Rule to be arbitrary and capricious. Id. at 1074. 

The district court specifically based its determination that

the Final Rule was arbitrary and capricious under the APA on

six independent grounds. First, the court found that USDA

failed adequately to quantify the risk of Canadian cattle to

humans, instead relying on a qualitative statement that the risk

was “low” or “very low.” Id. at 1064-65. Without a quantitative assessment, the district court felt that it “ha[d] no way of

assessing the merits of the USDA’s actions.” Id. at 1065. 

Second, the district court held that USDA had erroneously

calculated the prevalence of BSE in the Canadian herd. Id. at

1065-66. USDA had divided the number of cases in the last

12 months (two) by the total size of the Canadian herd over

24 months of age (5.5 million) to arrive at a prevalence rate

of approximately 0.4 cases per million head of adult cattle.

Final Rule, 70 Fed. Reg. at 464. The district court rejected

this calculation, however, and instead adopted R-CALF’s

measure of 5.5 cases per million head.13 R-CALF I, 359 F.

Supp. 2d at 1066. 

13To achieve the rate of 5.5 cases per million head, R-CALF calculated

the prevalence of BSE among tested cattle in Alberta (one in 3,000) and

8748 RANCHERS CATTLEMEN v. USDA
Third, the district court found that USDA’s reliance on the

Canadian feed ban was unjustified. Id. at 1066-68. The court

found that the science was uncertain in this area and that

methods of BSE transmission other than consumption of contaminated feed may exist. Id. at 1066. It also found that the

feed ban had not been in place an adequate amount of time,

and that it was not fully effective because it allowed both

bovine blood and rendered animal fat in cattle feed. Id. at

1067-68. 

Fourth, the court found that USDA’s reliance on the

removal of SRMs to protect human health was also unjustified. Id. at 1068. According to the district court, evidence

indicated that “it is no longer reasonable to presume that there

is no risk of exposure to BSE infectious agents once an SRM

removal requirement is in place.” Id.

Fifth, the district court found that USDA’s failure to ban

the importation of pregnant cows was arbitrary and capricious. Id. at 1069. According to the district court, BSE may

be transmitted both maternally and through fetal bovine

blood. Id. Thus, because the Final Rule did not require heifers

to be pregnancy checked as a condition of entry into the

United States, calves born to imported cattle could become “a

vector for BSE infection in the U.S.” Id.

Finally, the district court found that USDA had failed to

respond adequately to comments recommending mandatory

BSE testing for Canadian cattle. Id. Because testing can identify a BSE infection up to three months before the cow shows

outward signs of the disease, the court found that testing

divided it by 60, the assumed amount by which tested cattle will have BSE

over untested cattle (because tested cattle, which show outward signs of

the disease, are more likely to have BSE than the population at large). The

result is one infected cow per 180,000 head of cattle, or approximately

5.56 per million.” 

RANCHERS CATTLEMEN v. USDA 8749
would be useful because it would “detect some cases of BSE

that would otherwise go undetected.” Id. In light of the “irreparable injury” that it believed a case of BSE would cause, the

court viewed USDA’s actions as arbitrary and capricious. Id.

In addition to finding the Final Rule arbitrary and capricious under the APA, the district court also relied on two

other bases for enjoining its implementation. First, the court

held that USDA had failed to satisfy NEPA’s procedural

requirements, both by failing to make its environmental

assessment available for public review and comment before

the Final Rule was published, and by failing to prepare an

environmental impact statement. Id. at 1069-71. Second, the

court concluded that USDA had violated the RFA by failing

to consider whether product labeling or voluntary BSE testing

would have mitigated the Final Rule’s impact on small businesses. Id. at 1071-73. 

Based on the above, the district court found that R-CALF

had raised “very serious questions on the merits.” Id. at 1074.

The district court also found that R-CALF, and the American

public, would be irreparably harmed by allowing the importation of Canadian beef. Id. at 1073-74. The court specifically

found that the introduction of BSE into the United States

would cause irreparable harm to the American public because

of the increased risk of vCJD to consumers of beef. Id. at

1073. Further, it found that the association with Canadian

beef would stigmatize all U.S. meat, causing a “serious, irreparable impact on ranchers in the U.S. and the U.S. economy.”

Id. Finally, the district court found that the NEPA violation,

in and of itself, would cause irreparable harm and warranted

preliminary injunctive relief. Id.

In light of its determination that R-CALF was likely to succeed on the merits, and that the balance of hardships tipped

in R-CALF’s favor, the district court issued a preliminary

injunction barring implementation of the Final Rule. Id. at

1074. Two weeks later, USDA filed this timely appeal.

8750 RANCHERS CATTLEMEN v. USDA
II. ANALYSIS

“A district court’s order granting a preliminary injunction

is subject to limited review.” Price v. City of Stockton, 390

F.3d 1105, 1109 (9th Cir. 2004). We will reverse “only where

the district court abused its discretion or based its decision on

an erroneous legal standard or on clearly erroneous findings

of fact.” Id. A reviewing court should generally refrain from

reviewing “the underlying merits of the case.” Southwest

Voter Registration Educ. Project v. Shelley, 344 F.3d 914,

918 (9th Cir. 2003) (en banc). Rather, “[a]s long as the district

court got the law right, it will not be reversed simply because

the appellate court would have arrived at a different result if

it had applied the law to the facts of the case.” Earth Island

Inst. v. United States Forest Serv., 351 F.3d 1291, 1298 (9th

Cir. 2003). 

“The standard for granting a preliminary injunction balances the plaintiff’s likelihood of success against the relative

hardship to the parties.” Clear Channel Outdoor, Inc. v. City

of Los Angeles, 340 F.3d 810, 813 (9th Cir. 2003). This circuit

has recognized two different sets of criteria for preliminary

injunctive relief. Under the traditional test, a plaintiff must

show: “(1) a strong likelihood of success on the merits, (2) the

possibility of irreparable injury to plaintiff if preliminary

relief is not granted, (3) a balance of hardships favoring the

plaintiff, and (4) advancement of the public interest (in certain

cases).” Save Our Sonoran, Inc. v. Flowers, 408 F.3d 1113,

1120 (9th Cir. 2005). The alternative test requires that a plaintiff demonstrate “either a combination of probable success on

the merits and the possibility of irreparable injury or that serious questions are raised and the balance of hardships tips

sharply in his favor.” Id. (emphasis in original). “These two

formulations represent two points on a sliding scale in which

the required degree of irreparable harm increases as the probability of success decreases. They are not separate tests but

rather outer reaches of a single continuum.” Id.

RANCHERS CATTLEMEN v. USDA 8751
As we conclude below, the district court’s finding that RCALF had a strong likelihood of success on the merits was

premised on legal error. Further, we disagree with the district

court’s assessment of the irreparable harm threatened by the

Final Rule. Thus, we hold that a preliminary injunction was

unwarranted in this case. 

A. Likelihood of Success on the Merits

The district court identified three distinct grounds for its

finding that R-CALF had a strong likelihood of success on the

merits: (1) that the Final Rule was arbitrary and capricious

under the APA; (2) that USDA had failed to satisfy NEPA’s

procedural requirements; and (3) that USDA had failed adequately to consider the Final Rule’s effect on small businesses, as required by the RFA. None of these grounds

withstands scrutiny.

1. Administrative Procedure Act

The APA provides that a court, when reviewing agency

action, shall “hold unlawful and set aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an

abuse of discretion, or otherwise not in accordance with law.”

5 U.S.C. § 706. An agency’s action violates this standard if 

the agency has relied on factors which Congress has

not intended it to consider, entirely failed to consider

an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it

could not be ascribed to a difference in view or the

product of agency expertise. 

City of Sausalito v. O’Neill, 386 F.3d 1186, 1206 (9th Cir.

2004) (quoting Motor Vehicles Mfrs. Ass’n v. State Farm Mut.

Auto Ins. Co., 463 U.S. 29, 43 (1983)). 

8752 RANCHERS CATTLEMEN v. USDA
[1] Regulations are presumed to be valid, and therefore

review is deferential to the agency. Nat’l Ass’n of Home

Builders v. Norton, 340 F.3d 835, 841 (9th Cir. 2003). All that

is required is that the agency have “considered the relevant

factors and articulated a rational connection between the facts

found and the choices made.” Id. Further, “[t]he court is not

empowered to substitute its judgment for that of the agency.”

Ariz. Cattle Growers’ Ass’n v. United States Fish & Wildlife

Serv., 273 F.3d 1229, 1236 (9th Cir. 2001). Deference to the

informed discretion of the responsible federal agencies is

especially appropriate, where, as here, the agency’s decision

involves a high level of technical expertise. Id. 

While review is therefore deferential, it is not toothless;

courts must conduct a “thorough, probing, in-depth” inquiry

into the validity of regulations. Nat’l Ass’n of Homebuilders,

340 F.3d at 841. This inquiry must be “searching and careful”

to ensure that the agency decision does not contain a clear

error of judgment. City of Sausalito, 386 F.3d at 1206; Nat’l

Ass’n of Homebuilders, 340 F.3d at 841. In performing this

inquiry, the court is not allowed to uphold a regulation on

grounds other than those relied on by the agency. Ariz. Cattle

Growers’ Ass’n, 273 F.3d at 1236 (“The reviewing court may

not substitute reasons for agency action that are not in the

record.”). 

[2] The district court failed to abide by this deferential standard. Instead, the district court committed legal error by failing to respect the agency’s judgment and expertise. Rather

than evaluating the Final Rule to determine if USDA had a

basis for its conclusions, the district court repeatedly substituted its judgment for the agency’s, disagreeing with USDA’s

determinations even though they had a sound basis in the

administrative record, and accepting the scientific judgments

of R-CALF’s experts over those of the agency. For example,

in assessing the prevalence of BSE in the Canadian herd, the

district court rejected USDA’s calculation and accepted the

RANCHERS CATTLEMEN v. USDA 8753
prevalence rate provided by R-CALF’s expert, completely

without explanation. R-CALF I, 359 F. Supp. 2d at 1066. 

The district court’s lack of deference may be attributable to

its misreading of the Animal Health Protection Act

(“AHPA”), 7 U.S.C. § 8301 et seq., the statute under which

the Final Rule was promulgated. Based on the AHPA’s statement of congressional findings, 7 U.S.C. § 8301, the district

court appears to have imposed a requirement on USDA that

its Final Rule present no additional risk to human or animal

health.14 See R-CALF I, 359 F. Supp. 2d at 1065 (“The

[AHPA] directs the Secretary of the USDA to protect the

health and welfare of the people of the United States.”). The

AHPA is, in fact, based upon congressional findings that “the

prevention, detection, control, and eradication of diseases and

pests of animals are essential to protect . . . animal health

[and] the health and welfare of the people of the United

States.” 7 U.S.C. § 8301(1). The provision of the Act under

which the Final Rule was promulgated, however, states only

that “the Secretary [of Agriculture] may prohibit or restrict

. . . the importation or entry of any animal, article, or means

of conveyance . . . if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into

14While the district court never explicitly stated that it was imposing

such a “zero-risk” requirement, its reasoning suggests that it did. For

example, the court faulted the agency for “presum[ing] that there is no risk

of exposure to BSE infective agents once an SRM removal requirement

is in place.” R-CALF I, 359 F. Supp. 2d at 1068. Similarly, the court found

the Final Rule arbitrary and capricious because the agency refused to act

to remove the “small probability” that BSE could be transmitted from a

pregnant Canadian cow to its offspring. Id. at 1069. 

Indeed, the district court appears to have required USDA to disprove all

scientific uncertainty associated with BSE. It noted, for example, that

there is no “conclusive scientific proof” that cattle feed is the only method

of BSE transmission. Id. at 1066. In other areas of the opinion, any level

of scientific uncertainty surrounding a USDA decision rendered that decision an “assumption.” E.g., id. at 1066, 1067, 1068; see also id. at 1074

(criticizing USDA for acting despite “uncertainties in the agency’s knowledge of the possible impacts on human and animal health”). 

8754 RANCHERS CATTLEMEN v. USDA
or dissemination within the United States of any pest or disease of livestock.” 7 U.S.C. § 8303(a)(1). 

[3] The AHPA was only recently enacted, in 2002, and, as

of yet, there are few reported cases interpreting its provisions.

Nonetheless, the statute’s terms indicate a congressional

intent to give the Secretary wide discretion in dealing with the

importation of plant and animal products. More to the point,

the AHPA does not impose any requirement on USDA that all

of its actions carry no associated increased risk of disease.

Indeed, the statute’s use of the word “may” suggests that the

Secretary is given discretion over such decisions as whether

to close the borders. See, e.g., United States v. George, 85

F.3d 1433, 1437 (9th Cir. 1996) (statute’s use of term “may”

“indicates that we should review a district court’s decision . . .

for abuse of discretion”). Although sparse, the AHPA’s legislative history also supports this view. See H.R. Conf. Rep.

107-424, reprinted in 2002 U.S.C.C.A.N. 141, 388 (in order

to best protect against animal disease, “a regulatory definition

of disease should be left to the discretion of the Secretary,”

which will allow “the agency to have maximum flexibility to

focus its resources and respond to new or emerging disease

threats”). It is also notable that open borders are a default

under the AHPA, and the Secretary can close them only if

“necessary” to prevent livestock disease. See 7 U.S.C. § 8303.

[4] The structure of the AHPA is therefore inconsistent

with the district court’s strict requirement that the USDA regulation remove all risk of BSE entering the United States.

Because the district court interpreted the statute to contain

such a requirement, its analysis of the Final Rule’s compliance with the APA was fundamentally flawed.15

15We are in no way, of course, implying that the Secretary has unlimited

powers to open and close the borders as he sees fit. As the AHPA’s structure indicates, however, the Secretary has considerable discretion to

decide when an open or closed border is appropriate. Absent a strong

showing that the Secretary is not exercising that discretion consistent with

the statutory requirements, his judgment should not be overturned. 

RANCHERS CATTLEMEN v. USDA 8755
Our own review of the Final Rule leads us to conclude that

the Secretary had a firm basis for determining that the

resumption of ruminant imports from Canada would not significantly increase the risk of BSE to the American population. In conducting this review, we believe it is appropriate to

view the BSE prevention measures currently in place as part

of a comprehensive system. Thus, rather than follow the “divide and conquer” strategy of analyzing each protective component of the regulatory system in isolation, we evaluate the

cumulative effects of the multiple, interlocking safeguards. 

USDA’s comprehensive protections begin, first, with the

low incidence of BSE in Canadian cattle. This assures that if

any infected cattle are imported, the number will be relatively

small.16 Next, Canada’s feed ban, which USDA considers

effective, and its import restrictions on cattle from areas with

high BSE rates, ensure that Canada’s prevalence rate will not

rise dramatically. Canada also takes other measures, such as

BSE testing and epidemiological investigations, that help it

find and understand the source of BSE in its cattle population,

which helps it further minimize the prevalence of BSE in its

herd. These steps ensure, as USDA found, that Canada’s

already low rate of BSE is decreasing. Final Rule, 70 Fed.

Reg. at 464. 

From the already low prevalence rate in the Canadian herd

as a whole, USDA permits the importation of only a subset of

those animals that are extremely unlikely to have BSE —

those under 30 months of age. In England, only 0.01 percent

of those animals diagnosed with BSE were under 30 months

of age. Meat Produced by Advanced Meat/Bone Separation

Machinery and Meat Recovery (AMR) Systems, 69 Fed. Reg.

1874, 1875 (Jan. 12, 2004). In addition, USDA’s scientific

evidence suggests that Canadian cattle under 30 months of

16For example, assuming two million cattle enter the United States from

Canada per year, less than one would be expected to have BSE based on

Canada’s prevalence rate of 0.4 cases per million head of adult cattle. 

8756 RANCHERS CATTLEMEN v. USDA
age will be far less likely to be in the advanced stages of BSE,

given that the incubation period of BSE depends on the

amount of BSE agent to which an animal has been exposed.

Based on Canada’s low BSE rate and its feed ban, Canadian

cattle should have a much lower exposure than English cattle,

resulting in a correspondingly greater incubation period.

Thus, the age restriction further reduces the risk of introduction of BSE from Canada’s herd. 

Inside the United States, the risk of dissemination of BSE

is addressed by the requirement that Canadian cattle be immediately slaughtered or fed and then slaughtered before they

reach the age of 30 months. Again, because of BSE’s lengthy

incubation period, this age limit helps to ensure that BSE will

not progress in any infected animals before they are slaughtered. Once they are slaughtered, the FDA’s feed ban ensures

that they will not be fed to other cattle, preventing further dissemination of the disease if, in fact, an imported cow were

infected. 

As for human health, cattle slaughtered in the United States

are subject to FSIS regulations designed to minimize the risk

that any infectious material will enter the human food supply.

These regulations largely prohibit parts of the central nervous

system and other cattle parts that have shown BSE infectivity

from contaminating human food. In addition, FSIS has placed

restrictions on the manner in which cattle may be slaughtered

— air compression devices are banned to protect against the

possibility that they might inject parts of the brain into the

bloodstream. FSIS regulations also require the removal of all

SRMs from slaughtered cattle, and they restrict the use in

human food of “mechanically separated beef” and meat

obtained from “Advanced Meat Recovery” systems. 

The final defense against human BSE infection is biological. The limited nature of the vCJD outbreak indicates that

there may be a substantial species barrier that prevents BSE

from easily infecting humans. Indeed, the fact that there have

RANCHERS CATTLEMEN v. USDA 8757
been only slightly over 150 confirmed cases of vCJD worldwide — orders of magnitude less than the number of cases of

BSE in cattle — suggests that humans likely do not contract

the disease easily. 

[5] This regulatory system, with its numerous overlapping

and complementary safeguards, is designed to minimize the

risk of BSE to American livestock and consumers. Thus, substantial evidence supports USDA’s conclusion that these protections will effectively achieve that goal. Further, a

comprehensive study commissioned by USDA, known as the

“Harvard-Tuskegee Study,” evaluated the likely effects of the

introduction of BSE into the United States. The study concluded that, if 10 infected cows were imported into the United

States from Canada, on average only three new cases of BSE

would result and the disease was “virtually certain” to be

eradicated from the United States within 20 years. 

Instead of evaluating the BSE safeguards as part of a larger

system, the district court parsed the regulations and faulted

USDA for any risk that a given step failed to remove. The district court listed six specific grounds as the bases for its finding that the Final Rule was arbitrary and capricious. We

examine each of them seriatim and conclude that none of

them supports its conclusion.

a. Lack of quantitative standards

The district court faulted USDA for “ma[king] assumptions

of qualitative judgments,” rather than performing “a quantitative assessment of the risk of various options.” R-CALF I, 359

F. Supp. 2d at 1065. It concluded that, “[p]resented with the

USDA’s conclusions that the risks to U.S. cattle and consumers are ‘low’ without any definition as to what that means and

why the risks presented by the Final Rule are acceptable, this

Court has no way of assessing the merits of the USDA’s

actions.” Id.

8758 RANCHERS CATTLEMEN v. USDA
[6] The district court’s imposition of such a bright-line prohibition on qualitative standards was incorrect. The Supreme

Court has made clear that courts should not upset agency

decisions, even those announced with “less than ideal clarity,”

if “the agency’s path may reasonably be discerned.” Alaska

Dep’t of Envtl. Conservation v. EPA, 540 U.S. 461, 496

(2004) (internal quotation marks omitted); see also Vigil v.

Leavitt, 381 F.3d 826, 833 (9th Cir. 2004); Nat’l Ass’n of

Homebuilders, 340 F.3d at 846. Moreover, the AHPA does

not require the Secretary to quantify a permissible level of

risk or to conduct a risk assessment. 

[7] Under this standard, the administrative record is an adequate basis for discerning USDA’s conclusions. For example,

USDA’s conclusion that the prevalence of BSE in the Canadian herd is “very low” is supported by its observation that

“Canada’s incidence rate of two infected cattle in 2003 out of

a population of 5.5 million cattle over 24 months of age [is

well below] OIE’s recommendation of less than two infected

cattle per million during each of the last four consecutive 12-

month periods within the cattle population over 24 months of

age.” Final Rule, 70 Fed. Reg. at 464. Similarly, the “very

low” risk of a consumer contracting vCJD is supported by its

finding that “the removal of SRMs effectively mitigates the

BSE risk to humans.” Id. at 465. Indeed, the HarvardTuskegee Study, one of the centerpieces of USDA’s rulemaking, concluded that SRM removal “would reduce . . . potential

human exposure to BSE by 95 percent.” Id. at 467. 

The low risk of a human developing vCJD is also supported

by USDA’s observation that “the number of cases of vCJD

identified to date suggest a substantial species barrier that

may protect humans from widespread illness due to BSE.” Id.

at 462. It is also supported by anecdotal evidence of vCJD

outbreaks in other parts of the world. In Switzerland, for

example, the BSE rate in 1995 was 73.6 cases per million

head of cattle, and has been above 20 for most of the past 10

years, see http://www.oie.int/eng/info/en_esbincidence.htm,

RANCHERS CATTLEMEN v. USDA 8759
yet Switzerland has not identified a single case of vCJD.

Finally, no case of vCJD has ever been attributed to Canadian

beef or to the North American meat supply. 

b. Prevalence of BSE in Canada

The district court concluded that “Canada has not conducted sufficient testing for BSE to accurately assess the rate

of BSE infection in Canada.” R-CALF I, 359 F. Supp. 2d at

1065. It also concluded that the actual rate of BSE in Canada

was “greater than 5.5 cases per million head of cattle . . . [putting] Canada on par with a number of European countries

with a BSE problem.” Id. at 1066. Based on this number, the

district judge found that the importation of “2-3 million head

of cattle from Canada during the remainder of 2005” presented a “potentially catastrophic risk of danger to the beef

consumers in the U.S.” Id. 

[8] The district court, in this instance, impermissibly substituted its judgment for that of the agency. The USDA, in its

Final Rule, calculated Canada’s BSE prevalence rate to be

between 0.3 and 0.4 per million head of cattle. Final Rule, 70

Fed. Reg. at 464. The district court gave no reason for departing from this calculation and, instead, adopting the calculation

of R-CALF’s expert wholesale. The district court did so even

though R-CALF’s calculation contained the same type of

unexplained assumptions that the court found fatal to the

Final Rule. For example, R-CALF’s expert assumed that cattle with outward signs of BSE are 60 times more likely to

have the disease than cattle with no symptoms, and assumed

that the prevalence rate of BSE in Alberta was representative

of the rate in Canada as a whole. 

[9] USDA, on the other hand, based its calculation of Canada’s BSE rate on OIE guidelines; indeed, the OIE website

lists Canada’s 2003 incidence rate as 0.33 and its 2004 rate as

0.149. See http://www.oie.int/eng/info/en_esbincidence.htm.

The district court erred by departing from USDA’s method of

8760 RANCHERS CATTLEMEN v. USDA
calculation, which was supported by the administrative

record, without providing any reason. Marsh v. Or. Nat. Res.

Council, 490 U.S. 360, 378 (1989) (“When specialists express

conflicting views, an agency must have discretion to rely on

the reasonable opinions of its own qualified experts even if,

as an original matter, a court might find contrary views more

persuasive.”); Nat’l Wildlife Fed’n v. United States Army

Corps of Eng’rs, 384 F.3d 1163, 1177 (9th Cir. 2004). 

c. Effectiveness of Canadian feed ban

The district court also questioned USDA’s reliance on the

Canadian feed ban. First, it found that there was “no conclusive scientific proof” that consumption of infected feed is the

only method of BSE transmission, commenting that transmission may occur through blood and saliva. R-CALF I, 359 F.

Supp. 2d at 1066-67. Second, the court found evidence that

the feed ban had not been effective, both because the ban had

only been in place for seven years and because the 4.2-year

average incubation period of BSE suggested that the infected

Canadian cows had contracted BSE well after the feed ban

was put in place. Id. at 1067. Finally, the court found gaps in

the ban, finding that both bovine blood and rendered animal

fat were allowed in animal feed and that both could transmit

BSE. Id. at 1067-68. 

As to the first reason, the USDA explicitly considered scientific evidence on alternative theories of transmission and

rejected them, finding that “oral ingestion of feed contaminated with the BSE is the only documented route of field

transmission of the disease.” Final Rule, 70 Fed. Reg. at 486;

see also id. at 491 (discussing infectivity of blood). 

[10] The trial court’s criticisms of Canada’s feed ban are

also baseless. The district court’s main criticism is that Canada’s feed ban had been in place for only seven and a half

years, not the eight years recommended by OIE guidelines.

Applying such a strict reading of OIE guidelines, however,

RANCHERS CATTLEMEN v. USDA 8761
was incorrect. According to a declaration submitted by the

Head of the International Trade Department of OIE, OIE recommends that an importing country evaluate the exporting

country’s risk mitigation measures as a whole, and “would not

consider it appropriate for the importing country to apply each

criterion as an item on a checklist.” Thus, “a deficiency in the

length of time a feed ban has been effectively applied could

be addressed through restrictions on the age of live cattle

imported.” The Final Rule reveals that this is precisely the

approach that USDA took. See, e.g., Final Rule, 70 Fed. Reg.

at 463 (discussing multiple criteria used to evaluate a potential minimal-risk region); id. at 548 (restricting imports of

Canadian cattle to those under 30 months of age). 

Nor do we agree that the 4.2-year average incubation

period demonstrates the ineffectiveness of Canada’s feed ban.

USDA explained that the incubation period of BSE in cattle

depends upon the level of exposure the cattle have to the BSE

agent. The 4.2-year figure was obtained from analyzing cattle

during the BSE epidemic in England, which represents the

highest level of exposure to BSE in history. Cows in Canada

can be expected to have a longer incubation period because of

their significantly lower levels of BSE exposure. 

[11] Finally, the district court also erred in criticizing the

Canadian feed ban based on its “gaps,” which allow blood

and rendered animal fat in cattle feed. As discussed above,

USDA considered BSE transmission through blood and determined that the science did not support ingestion of blood as

a means of transmission. Id. at 491. USDA also considered

transmission through fat and concluded that, provided the fat

is not impure, it poses no risk of transmission of BSE. Id. at

500-01 (discussing potential transmission of BSE through tallow). Again, the district court gave no reason for rejecting

USDA’s expert scientific opinion.

d. Effectiveness of SRM removal

[12] The district court also found that R-CALF had presented sufficient evidence to establish that “it is no longer rea8762 RANCHERS CATTLEMEN v. USDA
sonable to presume that there is no risk of exposure to BSE

infectious agents once an SRM removal requirement is in

place.” R-CALF I, 359 F. Supp. 2d at 1068. USDA’s conclusion that SRM removal is effective, however, had support in

the administrative record. See Final Rule, 70 Fed. Reg. at 467

(discussing Harvard-Tuskegee Study, which concluded that

SRM removal would reduce human exposure to BSE by 95

percent). 

e. Maternal transmission of BSE and fetal blood serum

The district court also found the Final Rule arbitrary and

capricious because it “does not prohibit cattle of breeding age

from being bred either before or after entering the U.S.,” and

“there is a small probability that BSE can be transmitted

maternally.” R-CALF I, 359 F. Supp. 2d at 1069. In addition,

the court found USDA’s prohibition of fetal blood serum to

be inconsistent with the possibility of allowing pregnant cows

to be imported into the United States. Id. 

[13] Contrary to the district court’s findings, however,

USDA has made it abundantly clear that cattle may not be

imported for breeding under the new regulations. Instead, they

must be immediately slaughtered, or fed and slaughtered

before they reach 30 months of age. Final Rule, 70 Fed. Reg.

at 548-49. Furthermore, USDA discussed the concerns that

the district court raised, and found that they were not sufficient to justify addressing. Id. at 515 (“Although some evidence suggesting maternal transmission exists, such

transmission has not been proven, and, if it occurs at all, it

occurs at very low levels not sufficient to sustain an epidemic.”). 

We also find that there is a basis for USDA’s disparate

treatment of fetal blood serum. As the district court acknowledged, fetal blood serum is used for “bovine vaccine production” and “bovine embryo transfer.” R-CALF I, 359 F. Supp.

2d at 1069. Because the serum is injected directly into an aniRANCHERS CATTLEMEN v. USDA 8763
mal’s bloodstream, it carries a higher risk of transmitting

BSE, and “might pose a risk of livestock if used in” these

applications. Final Rule, 70 Fed. Reg. at 502. Thus, any

inconsistency in the USDA’s approach to offspring of

imported Canadian cattle and fetal blood serum has an adequate explanation in the record. 

f. Mandatory testing of Canadian cattle

Finally, the district court held that it was arbitrary and

capricious for the agency not to require all Canadian cattle to

be screened for BSE, because the screening test could identify

some animals with BSE that would not otherwise be identified. R-CALF I, 359 F. Supp. 2d at 1069. The Final Rule,

however, contains a lengthy comment in which USDA

responded to requests for testing of Canadian cattle. Final

Rule, 70 Fed. Reg. at 475-76. USDA explained that, because

testing can only detect the disease two to three months before

a cow starts demonstrating clinical signs of the disease, a cow

may be infected and thus produce a false negative on a test.

Id. Because of the long incubation period of BSE, and the relatively short window in which non-targeted testing is effective, the USDA did not consider testing to be a “food safety”

measure. Id. Rather, testing was best used to determine if BSE

exists in a country and to determine its prevalence — goals

that can both be achieved by targeted testing of animals with

clinical signs of BSE. Id.

[14] Over the past few years, USDA’s policies regarding

BSE testing have been subject to a high degree of criticism.

See, e.g., Mad Beef Policy, Los Angeles Times, Jul. 1, 2005;

McGarity, supra, at 337-40. These criticisms have generally

focused on USDA’s refusal to allow voluntary testing of cattle, rather than its refusal to require mandatory testing of

Canadian cattle. Although these criticisms are not without

their valid points, we do not believe that they are so powerful

as to render USDA’s testing policy invalid. USDA’s approach

to BSE testing — that, until better tests are developed, pro8764 RANCHERS CATTLEMEN v. USDA
phylactic measures such as the feed ban and SRM removal are

the best methods of protecting human and animal health — is

defensible. While its wisdom may be subject to debate on the

merits, its choices are not so lacking support in the administrative record as to be “arbitrary and capricious.” 

g. Conclusion

In sum, USDA decided to reopen the border to Canadian

ruminants after making a reasoned determination that the

importation of a small number of BSE-infected cattle into this

country would not pose a serious risk to humans or livestock.

As part of its determination, USDA necessarily decided that

the risks inherent in the uncertainty surrounding the current

scientific understanding of BSE were insufficiently significant

to justify the continued exclusion of Canadian cattle. Rather

than criticizing USDA for allowing these risks as a part of its

policy, the district court should have evaluated whether there

was an adequate basis in the administrative record for

USDA’s conclusion that the risks were acceptable. 

[15] Our review of the record leads us to conclude that the

risks inherent in the Final Rule are small, and that the rule

likely is supported by an adequate administrative record. We

therefore conclude that the district court erred in finding that

R-CALF has a strong likelihood of success on the merits of

its APA claim. 

2. Regulatory Flexibility Act

We also conclude that the district court erred in concluding

that R-CALF has a strong likelihood of success on its claim

under the RFA. The RFA was passed in 1980 to “encourage

administrative agencies to consider the potential impact of

nascent federal regulations on small businesses.” Assoc. Fisheries of Maine, Inc. v. Daley, 127 F.3d 104, 111 (1st Cir.

1997). In certain cases, it requires agencies to publish an “initial regulatory flexibility analysis” at the time a proposed rule

RANCHERS CATTLEMEN v. USDA 8765
is published, and a “final regulatory flexibility analysis” at the

time a final rule is published. 5 U.S.C. §§ 603, 604. Judicial

review is available only of the final analysis. 5 U.S.C. § 611.

The RFA requires that a final analysis contain the following:

(1) a succinct statement of the need for, and objectives of, the rule;

(2) a summary of the significant issues raised by the

public comments in response to the initial regulatory

flexibility analysis, a summary of the assessment of

the agency of such issues, and a statement of any

changes made in the proposed rule as a result of such

comments; 

(3) a description of and an estimate of the number

of small entities to which the rule will apply or an

explanation of why no such estimate is available;

(4) a description of the projected reporting, recordkeeping and other compliance requirements of the

rule, including an estimate of the classes of small

entities which will be subject to the requirement and

the type of professional skills necessary for preparation of the report or record; and

(5) a description of the steps the agency has taken to

minimize the significant economic impact on small

entities consistent with the stated objectives of applicable statutes, including a statement of the factual,

policy, and legal reasons for selecting the alternative

adopted in the final rule and why each one of the

other significant alternatives to the rule considered

by the agency which affect the impact on small entities was rejected.

8766 RANCHERS CATTLEMEN v. USDA
5 U.S.C. § 604(a). 

The RFA imposes no substantive requirements on an

agency; rather, its requirements are “purely procedural” in

nature. United States Cellular Corp. v. FCC, 254 F.3d 78, 88

(D.C. Cir. 2001); see also Envtl. Defense Ctr., Inc. v. United

States EPA, 344 F.3d 832, 879 (9th Cir. 2003), cert. denied,

541 U.S. 1085 (2004) (“Like the Notice and Comment process required in administrative rulemaking by the APA, the

analyses required by the RFA are essentially procedural hurdles; after considering the relevant impacts and alternatives,

an administrative agency remains free to regulate as it sees

fit.”). To satisfy the RFA, an agency must only demonstrate

a “reasonable, good-faith effort” to fulfill its requirements.

United States Cellular, 254 F.3d at 88; Alenco Communications, Inc. v. FCC, 201 F.3d 608, 625 (5th Cir. 2000); Assoc.

Fisheries, 127 F.3d at 114. 

The district court faulted USDA for considering only two

alternatives in its final regulatory flexibility analysis: “leaving

the regulations unchanged or modifying the import requirements by either requiring that imported beef come from cattle

slaughtered at less than 30 months of age or continuing to

prohibit the entry of live ruminants.” R-CALF I, 359 F. Supp.

2d at 1072; see also Final Rule, 70 Fed. Reg. at 543. The district court held that the agency erroneously rejected the alternatives of a country-of-origin labeling program and voluntary

testing of slaughtered Canadian cattle. R-CALF I, 359 F.

Supp. 2d at 1072. 

[16] The district court erred in concluding that USDA did

not meet the RFA’s requirements. The Final Regulatory Flexibility Analysis, available at http://www.aphis.usda.gov/lpa/

issues/bse/risk_assessment/03-080-3_econ_analysis.pdf,

reveals that USDA conducted a detailed economic assessment

of the impact of its proposed rule on small businesses. It concluded that the majority of businesses affected by the proposed Final Rule would qualify as small businesses, and that

RANCHERS CATTLEMEN v. USDA 8767
the effect of the Final Rule was likely to vary depending upon

the sector of the cattle industry the business occupied, rather

than the size of the business. The negative economic effects

the rule would create would generally affect those on the supply side of the beef industry — primarily ranchers — while

those on the production side — feedlots and meat packers —

would tend to benefit from the rule. In this respect, the alternatives identified by the district court would not necessarily

ease the burden on small businesses; rather, they would reallocate the rule’s burden to small businesses in different sectors of the beef industry. Cf. Assoc. Fisheries, 127 F.3d at 115

(where the majority of businesses affected by a rule are small

businesses, “Congress’s desire to have agencies write rules

that distinguish . . . between big and small businesses has

diminished relevance.”). 

More importantly, the specific concerns the district court

raised were considered by USDA in its response to comments

on the rule. USDA rejected the first alternative — the implementation of a country-of-origin labeling program — because

it did not consider such a program to concern food safety or

animal health. Final Rule, 70 Fed. Reg. at 533. USDA

rejected the second alternative, voluntary BSE testing,

because it does not consider such testing reliable enough to be

used as a food safety measure, as discussed above. See Part

II.A.1.f, supra. Given that USDA discussed and rejected these

alternatives in the body of its Final Rule, the agency did not

err in failing to consider them as alternatives in its final regulatory flexibility analysis. See Assoc. Fisheries, 127 F.3d at

115 (“[S]ection 604 does not require that [a final regulatory

flexibility analysis] address every alternative, but only that it

address significant ones.”). 

3. National Environmental Policy Act

NEPA was enacted in 1970 to “promote efforts which will

prevent or eliminate damage to the environment and biosphere.” 42 U.S.C. § 4321; see also Robertson v. Methow Val8768 RANCHERS CATTLEMEN v. USDA
ley Citizens Council, 490 U.S. 332, 348 (1989) (“Section 101

of NEPA declares a broad national commitment to protecting

and promoting environmental quality.”). Like the RFA,

NEPA does not impose any substantive requirements on an

agency’s decision; rather, it mandates only a process that the

agency must follow. Id. at 350 (“NEPA itself does not mandate particular results, but simply prescribes the necessary

process.”). 

Under NEPA’s procedural requirements, an agency must

prepare a “detailed statement” on the environmental impact of

a proposed rule when that rule is a “major Federal action[ ]

significantly affecting the quality of the human environment.”

42 U.S.C. § 4332. NEPA provides no private right of action

to enforce its requirements. Stratford v. FAA, 285 F.3d 84, 88

(D.C. Cir. 2002). Thus, to bring suit to vindicate NEPA’s

requirements, a plaintiff must rely on the provisions of the

APA that confer “standing to an ‘aggrieved party’ within the

meaning of the substantive statute upon which the claim is

based.” Id.; see also 5 U.S.C. § 702; Clarke v. Sec. Indus.

Ass’n, 479 U.S. 388, 394-96 (1987). 

[17] To narrow the wide range of potential plaintiffs who

may assert a “procedural injury” under this section of the

APA, the Supreme Court has adopted a “zone of interests” test.17

See id. at 397 n.12 (stating that the purpose of the zone of

17R-CALF incorrectly argues that the Supreme Court’s decision in Bennett v. Spear, 520 U.S. 154 (1997), drastically narrowed the applicability

of the zone of interests test. In Bennett, the Court considered the specific

question of standing under the Endangered Species Act’s citizen-suit provision, not the APA. Id. at 161-62. It expressly found that the “ESA’s

citizen-suit provision . . . negates the zone-of-interests test” based on its

language and its purpose. Id. at 164-66. Thus, Bennett simply does not

address actions under NEPA. Indeed, this court has continued to use the

zone of interests test to evaluate the standing of NEPA plaintiffs after Bennett. See Save Our Sonoran, 408 F.3d at 1119; Cantrell v. City of Long

Beach, 241 F.3d 674, 679 (9th Cir. 2001); see also Stratford, 285 F.3d at

88 (applying the zone of interest test in a NEPA action). 

RANCHERS CATTLEMEN v. USDA 8769
interests test is “to exclude those plaintiffs whose suits are

more likely to frustrate than to further statutory objectives”).

This test imposes the requirement, beyond constitutional

standing requirements, that a plaintiff assert an interest “arguably within the zone of interests to be protected or regulated

by the statute or constitutional guarantee in question.” Nev.

Land Action Ass’n v. United States Forest Serv., 8 F.3d 713,

715-16 (9th Cir. 1993). Thus, to assert a claim under NEPA,

a plaintiff must allege injury to the environment; economic

injury will not suffice. Id. at 716 (“[A] plaintiff who asserts

purely economic injuries does not have standing to challenge

an agency action under NEPA.”); Stratford, 285 F.3d at 88

(“[A] NEPA claim may not be raised by a party with no

claimed or apparent environmental interest.”); W. Radio Serv.

Co. v. Espy, 79 F.3d 896, 902-03 (9th Cir. 1996) (“NEPA’s

purpose is to protect the environment, not the economic interests of those adversely affected by agency decisions.”) (internal quotation marks omitted). A plaintiff can, however, have

standing under NEPA even if his or her interest is primarily

economic, as long as he or she also alleges an environmental

interest or economic injuries that are “causally related to an

act within NEPA’s embrace.” Port of Astoria, Or. v. Hodel,

595 F.2d 467, 476 (9th Cir. 1979). 

The injuries alleged in R-CALF’s complaint do not fall

within NEPA’s zone of interests. R-CALF points to only one

paragraph in its complaint to justify its standing under NEPA.

Every allegation in this paragraph, however, concerns the economic interest of R-CALF members except the following: “RCALF USA members will also be adversely affected by the

increased risk of disease they face when Canadian beef enters

the U.S. meat supply.” 

[18] We conclude that this alleged harm is insufficient to

fall within NEPA’s zone of interests. As mentioned above,

“NEPA’s purpose is to protect the environment.” W. Radio

Serv. Co., 79 F.3d at 902; see also Stratford, 285 F.3d at 88

(“[A] NEPA claim may not be raised by a party with no

8770 RANCHERS CATTLEMEN v. USDA
claimed or apparent environmental interest.”). More specifically, NEPA is concerned with harm to the physical environment: “If a harm does not have a sufficiently close connection

to the physical environment, NEPA does not apply.” Metro.

Edison Co. v. People Against Nuclear Energy, 460 U.S. 766,

778 (1983); cf. Cantrell, 241 F.3d at 679 (“In NEPA cases,

we have described this ‘concrete interest’ test as requiring a

‘geographic nexus’ between the individual asserting the claim

and the location suffering an environmental impact.”). RCALF’s claimed interest, however, has no connection to the

physical environment; rather, it is solely a matter of human

health. While it is true that NEPA contains references to

human health in its statement of policy, see 42 U.S.C. § 4321,

as the Supreme Court has explained, those references are to

the statute’s goals, not its means. Metro. Edison Co., 460 U.S.

at 773 (“[A]lthough NEPA states its goals in sweeping terms

of human health and welfare, those goals are the ends that

Congress has chosen to pursue by means of protecting the

physical environment.”). Here, R-CALF has failed to show

any relationship between risks to human health and environmental harms. Cf. Port of Astoria, 595 F.2d at 476. 

[19] Because R-CALF has failed to allege any connection

to injury to the physical environment, its injury falls outside

of NEPA’s zone of interests. Even assuming R-CALF’s

alleged injury could satisfy the zone of interests test, however,

its NEPA claim must fail for the additional reason that RCALF lacks organizational standing to assert a NEPA challenge. 

An association has standing to bring suit on behalf

of its members when its members would otherwise

have standing to sue in their own right, the interests

at stake are germane to the organization’s purpose,

and neither the claim asserted nor the relief

requested requires the participation of individual

members in the lawsuit. 

RANCHERS CATTLEMEN v. USDA 8771
Friends of the Earth, Inc. v. Laidlaw Envtl. Serv. (TOC), Inc.,

528 U.S. 167, 181 (2000) (citing Hunt v. Wash. State Apple

Advertising Comm’n, 432 U.S. 333, 343 (1977)). R-CALF

fails the second of these three elements. 

As mentioned above, R-CALF is a “non-profit cattle association representing over 12,000 U.S. cattle producers on

issues concerning international trade and marketing.” As is

evident from the paragraph in its complaint that discusses

standing, economic issues are highly relevant to its purpose.

We do not see the connection, however, between the purported environmental interest that R-CALF attempts to raise

here and the “trade and marketing” interests it is organized to

protect. 

[20] We therefore hold that R-CALF lacks standing to

bring a NEPA challenge to the Final Rule. Thus, the district

court erred in permitting R-CALF to proceed with its NEPA

claim and in concluding that it had a likelihood of success on

that claim.18

B. Balance of Hardships

After finding that R-CALF had demonstrated a strong likelihood of success on the merits, the district court found that

the Final Rule carried a definitive risk of causing “significant

irreparable harm.” R-CALF I, 359 F. Supp. 2d at 1073. The

district court identified three ways in which the Final Rule

would cause such harm: the increased risk of vCJD to American beef consumers, unspecified environmental injury stemming from USDA’s failure to comply with NEPA, and injury

to the U.S. beef industry and the U.S. economy that would

result from a “stigma” that tainted Canadian beef would

inflict upon the U.S. meat supply. Id. We believe the district

18Given our holding that R-CALF lacks standing to bring a NEPA

claim, we need not address the district court’s conclusion that the possibility of environmental harm justifies its preliminary injunction. 

8772 RANCHERS CATTLEMEN v. USDA
court’s calculus overstated the harm that would result from

the rule. 

[21] If the Canadian herd were to have a higher infection

rate than the U.S. herd, the importation of Canadian cattle

might pose some increased risk to the health of the U.S. population, however slight. Even assuming, however, that the

introduction of a fatal disease into the United States would

constitute irreparable harm, cf. Harris v. Board of Supervisors, 366 F.3d 754, 766 (9th Cir. 2004) (accepting as irreparable harm “pain, infection, amputation, medical complications,

and death”), the record does not justify the conclusion that the

Final Rule makes such harm likely, or even probable. Rather,

based on the low incidence of BSE in the Canadian herd, the

numerous safeguards against BSE in this country, the lack of

any Canadian cattle under 30 months of age found with BSE,

and the lack of any case of vCJD attributable to Canadian

beef, any increased risk to human and animal health created

by the Final Rule is negligible. 

[22] In retrospect, the district court’s concern over the possibility of “stigma” harming the American beef industry

appears to be overstated. The record does not support the district court’s alarmist findings that the “irreparable economic

harm” the district court foresaw from the stigma of Canadian

beef will actually befall the American beef industry. Following the case of BSE diagnosed in a Washington State cow in

2003, consumer demand for, and confidence in, American

beef remained strong. Final Rule, 70 Fed. Reg. at 522.

According to USDA, American demand for beef in 2004 is

estimated to have increased seven to eight percent over 2003

levels. Yet, Canadian beef was flowing into this country

throughout 2004 under permits issued by USDA.19 This evi19The district court’s April 26, 2004, temporary restraining order prevented USDA only from expanding the categories of Canadian beef that

could be imported under existing importation permits. The court explicitly

limited its order to “all edible bovine meat products beyond those authorized by USDA’s action of August 8, 2003 (boneless bovine meat, boneless Veal (meat), and bovine liver) from cattle under the age of 30

months.” R-CALF TRO, 2004 WL 1047837 at *9. 

RANCHERS CATTLEMEN v. USDA 8773
dence belies the district court’s prediction of catastrophic

injury to the U.S. beef industry.20

C. Preliminary Injunction

[23] Contrary to the district court’s conclusion, we conclude that the Final Rule will likely survive judicial scrutiny

under the correct legal standard; thus, R-CALF has not shown

a likelihood of success on the merits of its action. We also

conclude that R-CALF has failed to make the requisite showing of irreparable harm. For these reasons, we must reverse

the district court’s preliminary injunction. See Kootenai Tribe

v. Veneman, 313 F.3d 1094, 1125-26 (9th Cir. 2002).

III. CONCLUSION

For the foregoing reasons, the district court’s grant of a preliminary injunction is 

REVERSED.

20Indeed, the district court’s finding of irreparable economic harm is

undermined by the industry itself. Numerous amici curiae briefs have

been filed in this case by organizations representing large sectors of the

American meat industry, all of whom seek reversal of the preliminary

injunction. If the Final Rule posed a true risk of exposing American beef

to an irreparable stigma one would not expect to see such a broad coalition

of industry members supporting its implementation. 

8774 RANCHERS CATTLEMEN v. USDA