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From: TSS ()
Date: May 24, 2006 at 6:34 am PST

BERLOWITZ.DOC 4/7/2006 1:05:16 PM
When bovine spongiform encephalopathy (BSE), or mad cow
disease, first struck the United States in December 2003, a debate
raged over whether the tragedy that decimated Great Britain’s beef
industry had finally reached U.S. shores, or whether the infected cow
was an anomaly which had somehow broken through a BSE “firewall.”
After major importers halted importation of U.S. beef, the
United States Department of Agriculture (USDA) announced longawaited
new regulations, including increased testing for BSE. Shortly
thereafter, two private producers petitioned the USDA for permission
to test their own cattle for BSE, and were turned down on the authority
of the 1913 Virus, Serum, and Toxin Act (VSTA).
† Author’s Note. At the time this note was written, Japan had refused to open its markets to
U.S. beef, although, as indicated within, Japan appeared to be succumbing to U.S. lobbying efforts.
The American pressure paid off, and on December 11, 2005, Japan reopened its market to American
beef products from cattle 20 months and younger. See Statement, Agric. Sec’y Mike Johanns Regarding
the Opening of the Japanese Market to U.S. Beef, Dec. 11, 2005, (follow
“Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then search by date) (last visited
Jan. 20, 2006).
Hong Kong and Singapore followed suit shortly after. See Statement, Agric. Sec’y Mike Johanns
Regarding Resumption of U.S. Beef Trade with Hong Kong, Dec. 29, 2005, (follow
“Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then search by date) (last visited
Jan. 20, 2006); News Release, Singapore Reopens Market to U.S. Beef, Jan. 19, 2006, (follow “Newsroom” hyperlink; then follow “Latest Releases” hyperlink; then
search by date) (last visited Jan. 20, 2006). Japan didn’t last long. On January 20, 2006, it reimposed a
complete ban on American cattle after receiving an American shipment containing beef with vertebral
column. See New U.S. Beef Import in Japan, BBC NEWS ONLINE, January 20, 2006, The USDA claimed the vertebral column
wasn’t specified risk material, but conceded it was a violation of the agreement between the United
States and Japan. See Statement, Agric. Sec’y Mike Johanns Regarding U.S. Beef Exports to Japan,
January 20, 2006, (follow “Newsroom” hyperlink; then follow “Latest Releases”
hyperlink; then search by date) (last visited Jan. 20, 2006).
To be sure, while the $1.4 billion Japanese market may eventually reopen to American beef, until
the BSE problem is addressed more satisfactorily, similar intractable issues will remain.
* J.D. Candidate, University of Illinois College of Law; B.A., Hampshire College (1993). I
want to thank the Institute for Agriculture and Trade Policy, especially Kristin Dawkins, Steve Suppan,
and Mark Ritchie, and the Farmers Legal Action Group, especially Carl Flink, Jess Anna Speier
and David Moeller, for their inestimable assistance and support at the birth of this project. Additionally,
many thanks to Amy Dickerson, Ashley Burden and Bryan Endres for their helpful insight, critiques,
and fine tuning of this note. Finally, my deepest appreciation goes to Laura for supporting me
not only throughout the writing of this note, but through three years of law school in Champaign, Illinois.
And to Miles APB—thank you for you.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
The second case of BSE in the United States arrived among a
mixture of criticism and praise. While some claimed the USDA’s
regulations were inadequate and unenforced, others pointed at the
agency’s BSE controls as minimizing BSE’s impact on the American
cattle herd. Either way, the second BSE case revealed inconsistencies
in USDA policy and pointed to the need for a more comprehensive
BSE prevention policy.
This note examines and questions the efficacy of the USDA’s
BSE testing policies. The author notes that the USDA inconsistently
enforces BSE prevention regulations and argues that increased testing
is necessary. The author also contends that the VSTA does not authorize
the USDA to prevent cattle producers from testing their cattle
for BSE.
To resolve the problem, the author recommends that the USDA
create a comprehensive BSE testing and tracking policy. The author
suggests that, among other things, the USDA widen the scope of testing
to include younger cows and more random tests. Moreover, the
USDA should license and regulate voluntary BSE testing. Finally,
the author proposes that tracking, labeling, and mandatory recall
policies and procedures be implemented by the USDA to more
closely follow and contain the disease.
Americans consume more beef than any other people in any other
country in the world.1 We slaughter and eat roughly thirty-five million
cattle per year,2 approximately one-eighth of a cow per person annually.
We relish our hamburgers, steaks, tacos, chili, meatloaf, and stews. Bone
marrow from cattle carcasses is turned into gelatin for marshmallows,
candy, jelly, dairy, and diet products.3 Dozens of common products—
including soap, toothpaste, mouthwash, shaving cream, deodorant, cosmetics,
pet food, pharmaceuticals, vitamins, antifreeze, asphalt, insecticides,
and, of course, leather4—contain by-products of the beef industry.5
1. See Beef and Veal Summary Selected Countries,
10LP/bf_sum.pdf (last visited Mar. 17, 2005).
2. See Background Statistics: U.S. Beef and Cattle Industry, Economic Research Service,
United States Department of Agriculture, (last visited
Mar. 17, 2005).
3. Stephanie Simon, Cows Come Home in Host of Products, One Animal Goes a Long Ways in
Terms of Numbers of Uses, L.A. TIMES, reprinted in SEATTLE TIMES, Jan. 6, 2004, at A1.
4. Leather spawns an entire other industry, worth approximately $1.8 billion annually in the
United States alone. See, e.g., Leather Statistics, Exporting Countries of Leather and Leather Products, (last visited
Mar. 17, 2005).
5. See Ask the Meatman, Beef By-Products,
20products.htm (last visited Mar. 17, 2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
Not only is our beef supply ample, but we proudly name it the safest in
the world.6
Until December 23, 2003, bovine spongiform encephalopathy
(BSE), popularly known as mad cow disease for its brain-destroying
properties which cause its victims to act erratically, was a plight spreading
primarily in Europe and Asia, most devastatingly in Britain.7 The
disease’s distance from American cattle markets, however, did not mean
the United States was unaware or unafraid of BSE. In response to a crisis
which caused the death of more than 160 people, the incineration of
millions of cattle, and billions of dollars in losses,8 American officials
ceased importation of beef from countries with BSE beginning in 1989
and banned the use of feed containing certain cattle parts,9 thought to be
a significant link in the causal chain of BSE,10 in 1997.11
The motivations for preventing a BSE outbreak in the United
States were manifold. Not only was BSE deadly to cattle, but its human
counterpart, variant Creutzfeldt-Jakob Disease (vCJD) is fatal and untreatable
in human beings.12 In addition, intense debate arose concerning
the possible impact of BSE on American health and the American beef
industry, ranging from severe to destructive, from fear-mongering to outright
denial.13 American officials were all too aware of BSE’s devastating
6. See, The Source for Bovine Spongiform Encephalopathy Information, (last visited Sept. 19, 2005) (This web site is owned and operated by Cattlemen’s
Beef Board & National Cattlemen’s Beef Association.); see also USAgNet, AMI: U.S. Beef is
Safe, Despite BSE Possibility, WISCONSIN AG CONNECTION, Nov. 19, 2004, http://www. (last visited Mar. 17, 2005).
7. Op-Ed, How Now Mad Cow? Are We Being Too Casual with Fatal Disease?, PHILA. DAILY
NEWS, Aug. 9, 2005, at 13.
8. See John Darnton, The Logic of the “Mad Cow” Scare, N.Y. TIMES, Mar. 31, 1996, § 4, at 1.
9. See Press Release, USDA Restricts Imports of Animals and Animal Products from Europe
(Dec. 12, 1997), news/1997/12/EUBSE.HTM (last visited Mar. 17,
2005). Although the USDA commonly refers to the feed restrictions as banning feeding “ruminants to
ruminants,” in fact the ban excludes cattle blood which is fed to cattle and which can transmit BSE.
See Donald G. McNeil, Jr., Testing Changes Ordered After U.S. Mad Cow Case, N.Y. TIMES, June 25,
2005, at 47; Editorial, Safer Beef, N.Y. TIMES, Aug. 13, 2005, at A10 [hereinafter Safer Beef].
10. See APHIS News & Info., Bovine Spongiform Encephalopathy, http://www.aphis.usda.
gov/lpa/pubs/fsheet_faq_notice/fs_ahbse.html (last visited Mar. 17, 2005).
11. The efficacy of this feed ban is the subject of fierce debate. See USDA Admits to 1000 Violations
of Mad Cow Rules, REUTERS, August 15, 2005,
violations [hereinafter 1000 Violations]; see also Posting of John Stauber,, to madcow@ (June 29, 2005) (on file with author) (“The 1997 regulations which required feed
mills to label cattle meat and bone ‘Do Not Feed to Ruminants’ specifically EXEMPTED CATTLE
BLOOD AND CATTLE FAT, which continue to be fed to calves and cattle legally and in massive
quantities. . . . In early 2004 the now-head of the Food and Drug Administration, Dr. Lester Crawford,
testified before Congress on the need to ban the feeding of ruminant blood to ruminants in the U.S.
Yet, the practice continues.”)
12. See World Health Org. [WHO], Variant Creutzfeldt-Jakob disease, Nov. 2002, http://www. (last visited Mar. 17, 2005).
13. See SHELDON RAMPTON & JOHN STAUBER, MAD COW U.S.A. (2004); Jeffrey Kluger, Could
Mad—Cow Strike Here? A Year After the British Cattle Scare, Some Scientists Fear a Broader Outbreak
of the Mysterious Disease, TIME, Jan. 27, 1997, at 52. But see Mad Cow Not a Problem in the
U.S., NCBA News, National Cattlemen’s Beef Association,
locationId=217&contentId=271&contentTypeId=2 (last visited Mar. 17, 2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
effect on the British meat industry and were determined not to permit
similar circumstances to unfold here.14
Unfortunately, the American luck did not last. On December 23,
2003, BSE arrived in the United States.15 A cattle farm’s discovery of a
BSE-infected cow in Washington state made international news.16 The
global audience instantly reacted. The two largest American beef importers,
Mexico and Japan,17 halted all shipments of American beef, as
did South Korea, Australia, Singapore, Hong Kong, Thailand, Taiwan,
Malaysia, and Russia.18
The United States Department of Agriculture (USDA), mandated
by Congress to protect the health and welfare of the people of the
United States,19 held multiple press conferences which were broadcast
worldwide, in part to assure the world that the infected cow was of Canadian
origin.20 Media worldwide shined its spotlights on BSE, with reports
dominating newspapers and airwaves through the Christmas and
New Year season.21 The American beef industry, whose exports were
worth more than $70 billion annually,22 assured the American public that
the American beef supply was safe.23
As a result of the incident, the USDA issued a series of new regulations
designed to increase protection against BSE.24 In addition, the
United States Food and Drug Administration (FDA) released two in-
14. Sandra Blakeslee, Stringent Steps Taken by U.S. on Cow Illness, N.Y. TIMES, Jan. 14, 2001, at
15. See Sec’y Ann M. Veneman, News Conference on BSE (Dec. 23, 2003), available at (follow “Newsroom” hyperlink; then follow “transcripts and speeches” hyperlink).
16. See U.S. Confirms First “Mad Cow” Case, BBC NEWS ONLINE, Dec. 25, 2003, http://news.
17. The Japanese beef market is worth more than $1.7 billion to American producers. See
Statement, Agric. Sec’y Ann M. Veneman Regarding Resumption of Beef Trade with Japan, Oct. 23,
2004, (follow “Newsroom” hyperlink; then follow “Latest Releases” hyperlink;
then search by date) (last visited Mar. 17, 2005).
18. See U.S. Mad Cow Scare Spreads to Asia, Mexico, Brazil, U.S.A. TODAY, Dec. 24, 2003; see
also Countries Take Steps to Ban U.S. Beef, WALL ST. J., Dec. 24, 2003.
19. See Animal Health Protection Act, 7 U.S.C.A. §§ 8301(1)(B), (5)(B)(iii) (West Supp. 2005).
20. See Statement, USDA BSE Update (Dec. 27, 2003),
03.html (last visited Sept. 19, 2005).
21. See David Rennie, Nations Bar American Beef After First Mad Cow Case, THE DAILY
TELEGRAPH (London), Dec. 26, 2003, at 8; Scarce Beef Up Stocks, HERALD SUN (Melbourne), Dec.
25, 2003, at World 21; Alla Startseva, Mad Cow in America Prompts Ban on Beef, MOSCOW TIMES,
Dec. 25, 2003, at 2834; Taig Uranka, Japan’s Eateries, Stores in Shock, THE JAPANESE TIMES, Dec. 25,
22. See Foreign Agric. Services, U.S. Dep’t of Agric., Global Cattle and Beef Statistics, Beef and
Veal Summary Selected Countries (2004),
pdf (last visited Mar. 17, 2005).
23. See BSE Update from NCBA (Dec. 28, 2003),
Info_Page/bse_update_from_ncba_12.28.03.htm (last visited Mar. 17, 2005); see also Sherri Day, A
Time for Finesse: Marketing Beef After a Mad Cow Discovery, N. Y. TIMES, Jan. 1, 2004, at C1.
24. See Sec’y Ann M. Veneman, Announcing Additional Protection Measures to Guard Against
BSE (Dec. 30, 2003), available at
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
terim final rules to help prevent BSE.25 Within days of the discovery,
however, beef stock prices plummeted, followed by weakening sales.26 In
response, the beef industry attempted to influence public opinion by
filming nondiseased cattle and sending the films to more than two dozen
national, cable and local television stations.27
But as Britain had already learned, the BSE label was difficult, or
impossible, to shake. On June 24, 2005, a second cow with BSE was discovered
in the United States.28 Unlike the cow in the first American BSE
case, which tested immediately positive for BSE, and which the USDA
was quick to announce was of Canadian origin, this cow was of American
origin.29 But even more disturbing was that this cow had been tested for
BSE in November 2004, only seven months earlier. At that time, however,
the test results were “inconclusive.”30 The sample had been retested
only on the recommendation of the USDA’s Office of Inspector
General during its investigation of the USDA’s handling of BSE.31
While the first case of BSE in the United States was quickly written
off as a Canadian problem which had slipped over the U.S. border, the
second is more difficult to regard as an anomaly, especially when the
USDA’s own surveillance system failed to detect it. Even though at the
time of this writing there have been no more American cases, it is all but
certain that more cases will arise.32 Moreover, Japan—the largest international
importer33—still has not resumed American beef imports, although
it recently began to be persuaded by American negotiators.34
25. See News Release, U.S. Dep’t of Health and Human Services, Expanded “Mad Cow” Safeguards
Announced To Strengthen Existing Firewalls Against BSE Transmission (Jan. 26, 2004), http:// (last visited Mar. 17, 2005).
26. See Jennifer Bayot, Mad Cow Disease in the United States: The Market; Many Stocks Linked
to Beef Continue Fall, N.Y. TIMES, Dec. 27, 2003, at A14.
27. See Day, supra note 23.
28. See News Release, USDA Announces BSE Test Results and New BSE Confirmatory Testing
Policy (June 24, 2005), available at (follow “Newsroom” hyperlink; then follow
“Latest Releases” hyperlink; then search by date) [hereinafter New BSE Results].
29. Not only was the cow American born, but it was born before the 1997 FDA feed ban. Id.
30. See New BSE Results, supra note 28.
31. See id.; see also USDA Office of Inspector General Statement on Audit Work Related to the
BSE Test Result Announced on June 10, 2005,
BSEStatement050615.pdf (last visited Oct. 2, 2005).
32. See Jason R. Odeshoo, Note, No Brainer? The USDA’s Regulatory Response to the Discovery
of ‘Mad Cow’ Disease in the United States, 16 STAN. L. & POL’Y REV. 277, 278–79 (2005); see also Vedantam
Shankar, Assessing Risks of Mad Cow: Other Animals Likely Infected, Scientists Say, WASH.
POST, Jan. 11, 2004, at A09.
33. See Odeshoo, supra note 32 at 288.
34. Japan has said it won’t consider lifting the ban until the United States tests all of its cattle for
BSE. Id. The United States, however, has been pressuring Japan to resume the beef trade. See Safer
Beef, supra note 9. On March 17, 2005, Japan informally agreed to partially lift its ban, limited to
American cattle under 20 months of age, but the terms of this deal have not been worked out yet. See,
e.g., Embassy of the U.S., Japan, Questions and Answers on BSE (2005),
p/tp-20050304-71.html (last visited Mar. 17, 2005); U.S. Statement at WTO on Japan’s Beef Import
Ban (Mar. 9, 2005), http://tokyo.usembassy. gov/e/p/tp-20050309-77.html (last visited Mar. 17, 2005).
But in late September 2005, Japan’s Food Safety Commission postponed a decision on whether to resume
imports of American beef. See Farm Minister Rebuffs U.S. Pressure to Resume Beef Imports,
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
More than just a second BSE case, however, clouds the USDA’s
apparent commitment to its food safety mandate. In May 2003, for example,
the United States banned imports of all Canadian beef into the
United States after an outbreak of BSE in Canada.35 Four months later,
though, the USDA violated its own ban and allowed more than thirtythree
million pounds of Canadian beef to be imported into the United
States over a six-month period;36 this practice continued until a federal
district court imposed an injunction on the USDA in May 2004.37
In addition, between December 2003, when the first mad cow was
discovered, and June 2005, when the second mad cow was discovered,
BSE prevention measures—such as the 1997 FDA feed ban, the ban
against human food from advanced meat recovery machines, and reliable
testing for BSE—were regularly violated.38
Finally, in February 2004, the food safety agency made a decision
that appeared to be against food safety. The USDA prohibited an
American beef producer, Creekstone Farms, from testing all of its cattle
voluntarily for BSE.39 The USDA claimed the 1913 Virus, Serum, and
Toxin Act (VSTA) gave it authority to regulate the test for BSE, and
claimed Creekstone’s request was scientifically unjustified.40 The National
Cattlemen’s Beef Association, the largest cattle industry group,
formally opposed to voluntary testing on the grounds that it will lead to
mandatory testing, approved the USDA’s decision.41
The USDA’s denial of Creekstone’s request brought into question
the agency’s commitment to stopping the spread of BSE. First, the
USDA’s extremely broad interpretation of the ninety-two-year-old
VSTA was suspect; the agency had never before cited the law for any
MAINICHI DAILY NEWS, Sept. 30, 2005,
20050930p2g00m0bu020000c.html (last visited Oct. 2, 2005).
35. See 9 C.F.R. § 94.18 (2005); see also Statement, Agric. Sec’y Ann M. Veneman, Statement
Regarding Canada’s Announcement of BSE Investigation (May 20, 2003), available at http://www.!ut/ (search “BSE Related Releases;” then follow “BSE Related Releases” hyperlink
and “Announcement of BSE Investigation” hyperlink).
36. See Marc Kaufman, USDA Allowed Canadian Beef In Despite Ban, WASH. POST, May 20,
2004, at A01.
37. See R-CALF v. USDA, No. CV-04-BLG-RFC, at *1–2 (D. Mont. May 4, 2004) (order granting
preliminary injunction), available at (last visited
Mar. 17, 2005).
38. See Safer Beef, supra note 9; see also 1000 Violations, supra note 11.
39. Telephone Interview with Bill Fielding, Chief Operating Officer, Creekstone Farms (June 3,
2004) [hereinafter Interview with Bill Fielding].
40. Id.; see also Creekstone Farms to Challenge USDA’s Decision to Decline Private BSE Testing
(Apr. 9, 2004), html (last visited Mar. 17,
2005); Press Release, Statement by Bill Hawks, Undersecretary for Marketing and Regulatory Programs
Regarding a Request by Creekstone for Private BSE Testing, Release No. 0141.14 (Apr. 9,
2004), available at (“The test is now licensed for animal
health surveillance purposes. The use of the test as proposed by Creekstone would have implied a
consumer safety aspect that is not scientifically warranted.”).
41. See National Cattlemen’s Beef Association, Questions Producers Are Asking about BSE
Testing, areaskingaboutbsetesting3406.aspx (last visited
Mar. 17, 2005); see also Safer Beef, supra note 9.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
purpose outside of the regulation of animal vaccines.42 Second, in a time
when consumers are armed with greater information and are demanding
safer food than ever before, consumer demand for increased BSE testing,
and a private producer’s response to that, seems far from unreasonable.
Above all, however, because of the vertical integration of the American
beef market,43 BSE can conceivably be controlled, if not eliminated,
through strict controls and comprehensive testing.44 While the USDA
has implemented some of those controls, critics assert that the USDA’s
efforts fall short and have been influenced too strongly by industry interests.
45 The USDA, based on its Congressional mandate, must incorporate
consumer and producer demands into its policies and protect the
food supply from BSE.
This note will propose that instead of maintaining the status quo for
BSE policy—minimizing food safety and promoting dominant industry
concerns over smaller ones—the USDA should implement a more comprehensive
BSE testing policy. The policy should incorporate a mix of
mandatory and voluntary testing to ensure the largest possible number of
cattle are tested, while working to open foreign markets for American
beef on the basis of the reliability of that testing. Part II will explore the
background of BSE, examine the issues complicating BSE testing, and
report the stories of Creekstone and Gateway, two American producers
prohibited by the USDA from testing their own cattle for BSE. Part III
begins with an analysis of the VSTA, the statute used by the USDA to
prevent private testing, and then illuminates American BSE testing policy
within the context of food safety, international trade, and industry influence.
Finally, Part IV will propose a more comprehensive BSE testing
scheme that combines USDA authority with industry concerns and consumer
food safety protection.
BSE had never been found in the United States until the USDA
confirmed the Washington State case on December 23, 2003.46 From the
first press conference and through the first weeks, the USDA appeared
alert and ready to police the problem.47 The USDA recalled meat from
42. See infra note 189 and accompanying text.
43. See Note, Challenging Concentration of Control in the American Meat Industry, 117 HARV. L.
REV. 2643, 2644 (2004).
44. See infra text accompanying notes 218–35.
45. See generally, RAMPTON & STAUBER, supra note 13, at 1–5; see also The Politics of Mad Cow
Disease, CBS News, Dec. 29, 2003, 590466.html
(last visited Mar. 17, 2005).
46. See Transcript, News Conference With Agriculture Secretary Ann M. Veneman on BSE, Release
No. 0433.03 (Dec. 23, 2003), (last visited Mar. 17,
47. See Anahad O’Connor, New Measures Against Mad Cow Disease, N.Y. TIMES, Dec. 31, 2003,
at A15.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
twenty cows processed with the infected cow in Washington, more than
10,000 pounds of beef.48 It prohibited releasing cows tested for BSE until
they tested negative.49 Strict limits were placed on the uses of the skull,
spinal cord and spinal nerve tissue (specified risk materials, or SRM)
from cattle older than thirty months and small intestines from all cows.50
Downers, cows too sick to walk, were banned from the human food supply,
and air injections used to stun cattle before slaughter were prohibited
because they scattered possibly infected bone and brain segments
into the other meat.51 Finally, the USDA committed to instituting a national
animal tracking system.52
After BSE’s second appearance in the United States, the USDA altered
its testing policy by mandating the use of a pair of confirmatory
BSE tests whenever the primary BSE test shows an “inconclusive” result.
53 The arrival of a second infected cow in the United States, however,
suggested that greater controls against BSE—or greater enforcement
of existing controls—were needed.
In order to more fully analyze the significance of BSE, the USDA’s
response to BSE, and the interests of the beef industry and consumer
groups, this section will more carefully define BSE. It will describe the
methods of testing for BSE, the USDA’s testing policy, and problems
with that policy. In addition, this section will introduce the deeper inconsistencies
in the USDA’s testing policy: the story of Creekstone and
Gateway Farms, and the story of Canadian BSE and Canadian beef.
A. What Is BSE and How Is It Transmitted?
BSE, and its human form, vCJD, are in a disease family called
TSEs, or transmissible spongiform encephalopathies, which occur naturally,
although extremely rarely.54 Scientists believe that BSE is caused
by the presence of abnormal prions, proteins naturally occurring on the
brain cells of cattle that convert into rapidly unstable protein structures.55
Dr. Stanley Prusiner, who won the Nobel Prize for discovering the un-
48. Id.
49. Id.
50. Id.
51. Id.
52. Id.
53. See New BSE Results, supra note 28; McNeil, supra note 9; see also infra notes 89–104 and
accompanying text.
54. See Centers for Disease Control, Prion Diseases, (last
visited Mar. 17, 2005).
55. See FDA, Commonly Asked Questions About BSE,
html (last visited Mar. 17, 2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
stable disease-causing proteins in 1997,56 has been an outspoken proponent
for a more comprehensive BSE testing policy.57
The BSE crisis in England, which led to the slaughter of 3.7 million
cattle,58 indicated that something more than the natural occurrence of
BSE was spreading the disease. Several theories abounded.59 Evidence
of a species barrier-jump theory was bolstered when it was revealed that
rendered sheep parts fed to British cattle as protein in the 1970s were infected
with a sheep form of TSE, known as scrapies.60 Some believed
that feeding rendered cattle parts to cattle, an herbivorous species, led to
the abnormal proteins, or prions, being formed.61 Yet others believed
that the disease spread due to changes in the technology used to create
the cattle-based feed. The theory asserts that changes in the 1970s, both
in regulation of the chemicals involved in rendering and new rendering
methods, resulted in a lower rendering temperature which failed to kill
the prions that had been killed in the previous process.62 Yet even if BSE
developed like many other diseases, as a combination of undeterminable
chemical, physical, political, and even economic factors, what was clear
after the British BSE crisis was that BSE was transmissible, and remarkably
The effect of BSE on cattle is untreatable and well-documented.64
The prions slowly attack the brain tissue, causing holes to form, similar to
the patterns in a sponge.65 As the brain loses function, the cows become
disoriented and clumsy.66 Eventually, the cattle lose all muscle control
56. See Press Release,, The 1997 Nobel Prize in Physiology or Medicine (Oct. 6,
1997), (last visited Feb. 28, 2006).
57. See Clint Peck, The Cost of One Sick Cow, BEEF, June 1, 2004,
cost_one_sick/ (“Dr. Stanley Prusiner says the only way to assure beef is BSE-free is test all cattle at
slaughter.”) (last visited Feb. 28, 2006).
58. See The Spread of Mad Cow Disease,, Dec. 24, 2003,
HEALTH/12/23/madcow.chronology.reut/ (last visited Feb. 28, 2006).
59. See Animal and Plant Health Inspection Serv., USDA, Bovine Spongiform Encephalopathy
(BSE), Overview, available at [hereinafter
Bovine Spongiform Encephalopathy].
60. See id. (“The causative agent is suspected to be from either scrapie-affected sheep or cattle
with a previously unidentified BSE.”).
61. See id.
62. See id; see also RAMPTON & STAUBER, supra note 13, at 68–69.
63. See Bovine Spongiform Encephalopathy, supra note 59. BSE is unresponsive to medicine in
the cattle, or high sterilization temperatures used to disinfect other foods. Id. In addition, BSE is currently
believed only to live in the spinal tissues, brain tissues, and intestines of cattle; the discovery that
BSE can live in more normally consumed parts such as muscles or livers would be disastrous, and
there has been little evidence of this to date. See FDA, Commonly Asked Questions About BSE in
Products Regulated by the FDA, (last visited Aug. 19,
2005). The theory behind the ban on air injection, however, is an acknowledgement that brain tissue
has the potential to infect other parts of the cattle, including muscle, the most common part of the cow
to eat, through the killing process. See O’Connor, supra note 47, at A15. Like any other regulation,
the proof is in the compliance, which remains to be seen.
64. Bovine Spongiform Encephalopathy, supra note 59.
65. Id.
66. Id.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
and are unable to walk or eat.67 No treatment is available; once BSE is
contracted, all cattle die or are destroyed.68
The human form of BSE, vCJD,69 is equally insidious, although humans
have benefited from attempts at treatment.70 Victims first become
forgetful and depressed. Brain function decreases rapidly, resulting in
loss of memory, and eventual loss of language, causing a schizophreniclike
psychosis.71 Muscle control is lost; victims’ limbs become uncontrollable
and jerky, their voices random and erratic.72 For example, a fourteen-
year-old girl in England cried for two weeks straight, and then began
screaming before finally dying.73 Death after onset is normally quick;
a healthy patient can succumb to vCJD and die in a matter of months.74
B. Testing for BSE
Three BSE tests currently exist, all having in common the impossibility
of testing live animals.75 The rapid test, used first in USDA surveillance,
starts with a sample of bovine central nervous tissue dissected
from the hind brain or upper cervical spinal column.76 The sample is homogenized
to liquefy the tissue and then centrifuged.77 Enzymes digest
the normal prions and leave untouched the abnormal prions, which are
then tested with antibodies to detect BSE.78 The rapid test is not perfect;
many believe it gives false positive results.79
The second test is the “gold-standard” immunohistochemistry test
(IHC), which the USDA uses to confirm the results of the rapid test.80
67. Id.
68. Id.
69. See supra note 54. Although the incubation period for traditional CJD could be as long as
20–30 years, and naturally attacks about only one per million people, the variant form seems to incubate
more quickly, attack more ferociously, and have the potential for much more widespread damage.
70. See CJD Drug Study to Start in Weeks, BBC NEWS ONLINE, May 21, 2004, (last visited Feb. 28, 2006).
71. See Stefanie M. Gaffigan, Comment, Developments in International Trade and the Environment,
2003 COLO. J. INT’L. ENVTL. L. & POL’Y (Yearbook) 87, 87.
72. See David Schardt & Stephen Schmidt, Mad About BSE, NUTRITION ACTION HEALTH
LETTER (U.S. Edition), ‘Center for Science in the Public Interest’, July/Aug. 1997, http://www.cspinet.
org/nah/ja-bse.htm (last visited Feb. 28, 2006).
73. Rebecca Allison, The Cries then Screams that Led a Mother to Discover her 14-Year-Old
Daughter had CJD, GUARDIAN UNLIMITED (UK), Oct. 26, 2000,
0,2763,388251,00.html (last visited Feb. 28, 2006).
74. See Bovine Spongiform Encephalopathy, supra note 59.
75. See id.
76. See TSE Screening Process,
test=bse&path=1 (last visited Mar. 17, 2005).
77. Id.
78. Id.
79. See Donald G. McNeil & Sandra Blakeslee, Second Test Indicates Animal Did Not Have Mad
Cow Disease, N.Y. TIMES, July 1, 2004, at A19.
80. Id. As a result of the BSE found in Washington in December 2003, the USDA expanded its
testing of cattle for BSE, expecting to test more than 220,000 cattle in 2004, a greater than tenfold increase
over 2003. Letter from Jean Halloran, Dir. Consumer Policy Inst., & Michael K. Hansen, SenBERLOWITZ.
DOC 4/7/2006 1:05:16 PM
The IHC also uses a sample of brain tissue, which is treated with enzymes
and examined under a microscope.81 While the USDA believes
this test to be more reliable than the rapid test, it is widely believed that
“[t]he accuracy of the test depends on the expertise of the examiner.”82
The third test, the Western blot test, was described by the USDA as
“crucial” in identifying the positive Washington State cow in December
2003, but until June 24, 2005 was not part of the USDA testing protocol.83
The testing standard of European Union countries and Japan,84 both the
IHC and the Western blot, will now be used to confirm the results of an
“inconclusive” result on a rapid test.85 Critics claim the IHC misses some
BSE cases, while the Western blot is both more sensitive and less prone
to misinterpretation than the IHC.86
In addition to the complexities of the BSE test, the testing process
itself is far from straightforward.87 As this note will show, the difference
between testing cattle for BSE and the USDA’s surveillance testing—
testing cattle to determine the statistical incidence of BSE—can be
analogized as the difference between solving a problem and creating a
committee to discuss solving the problem. Further, the effectiveness of
BSE testing can be manipulated by decisions about which cattle to test
under what conditions, notification of testing, and a selective voluntariness
to testing.88
C. USDA Testing Policy
In March 2004, the USDA announced the introduction of its surveillance
program to determine the rate of BSE infection in the United
ior Research Assoc., to Michael Johanns, Sec’y, USDA (Feb 24, 1005),
pub/campaignnotinmyfood/001931.html (last visited Mar. 17, 2005). Approximately 35.5 million cattle
were slaughtered in 2003. Background Statistics on U.S. Beef and Cattle Industry, Coverage.htm (last visited Mar. 17, 2005). The USDA first uses
the rapid test, and then the IHC to certify any positive results. Halloran & Hansen, supra. (There
remains some controversy as to the accuracy of both the rapid tests and the IHC tests: the USDA
publicly refers to positive rapid-test results as “inconclusive” while referring to the IHC tests as conclusive.
See Statement, Dr. John Clifford, Deputy Adm. APHIS (July 2, 2004),
Newsroom/0275.04.html (last visited Mar. 17, 2005)). As of March 17, 2005, three tests have come
back positive (or “inconclusive”) for BSE using the rapid test, all of which have been found to be
negative by the subsequent IHC tests. See Factsheet, Animal and Plant Health Inspection Service,
June 2005 BSE Test Step by Step,
stepbystep.pdf (last visited Sept. 19, 2005).
81. McNeil & Blakeslee, supra note 79.
82. Id.
83. See New BSE Results, supra note 28; see also Halloran & Hansen, supra note 80.
84. Halloran & Hansen, supra note 80.
85. See New BSE Results, supra note 28; see also infra text accompanying note 97.
86. Halloran & Hansen, supra note 80.
87. See TSE Screening Process, supra note 76.
88. Ranchers are encouraged to report downer cattle to the USDA for testing. Stephanie
Simon, U.S., Some Ranchers Clash over Mad Cow Tests, L.A. TIMES, May 24, 2004, at A11.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
States.89 Using a Harvard University statistical model,90 the USDA
stated that testing 268,500 high risk animals would result in being able to
detect BSE in one out of ten million cattle with 99% accuracy.91 The
USDA claimed it could detect BSE even if there were only five BSEpositive
animals in the United States.92 High risk animals were defined
as animals that were at least thirty months old and nonambulatory, demonstrating
signs of a disorder of the central nervous system, emaciation
or injury (signs of BSE), or dead. Approximately 446,000 animals in the
United States fell into this category.93
Since June 1, 2004, when the surveillance testing began, a total of
478,050 cattle have been tested by the USDA.94 As of this writing, three
“inconclusive” results have been reported, one of which led to the discovery
of the second American cow with BSE.95 The USDA defines inconclusive
tests as those in which a “negative result cannot be determined.”
96 According to the USDA, the tests are designed to be highly
sensitive, and false positives are normal under these circumstances.
These “non-negative,” or inconclusive, results are sent to another lab,
where now the “gold-standard” IHC and the Western Blot will be performed.
D. Problems with the USDA’s Testing Policy
Consumer groups questioned why the USDA insisted that BSE testing
was for surveillance purposes only, rather than for food safety, when
89. See generally Bovine Spongiform Encephalopathy (BSE) Surveillance Plan (2004), http:// (last visited Mar. 17, 2005) [hereinafter
BSE Surveillance Plan].
90. See generally, Preliminary Analysis of Interim Final Rules and an Interpretative Rule to Prevent
the BSE Agent from Entering the U.S. Food Supply, available at
RDAD/FRPubs/03-025N/BSE_Analysis.pdf (citing Joshua T. Cohen & George M. Gray, Evaluation
of the Potential Spread of BSE in Cattle and Possible Human Exposure Following Introduction of Infectivity
into the United States from Canada 2003, Harvard Center for Risk Analysis, Harvard School of
Public Health); see also Joshua T. Cohen & George M. Gray, Evaluation of the Potential Spread of
BSE in Cattle and Possible Human Exposure Following Introduction of Infectivity into the United
States from Canada 2003, Harvard Center for Risk Analysis, Harvard School of Public Health, available
at harvard_10-3/text_wrefs.pdf (last visited Mar. 17,
2005); Joshua T. Cohen et al., Evaluation of the Potential for Bovine Spongiform Encephalopathy,
Harvard Center for Risk Analysis, Harvard School of Public Health, available at http://www. risk_assessment/mainreporttext.pdf (last visited Mar. 17, 2005).
91. See USDA’s BSE Testing Program, Frequently Asked Questions, http://www.aphis.usda.
gov/lpa/issues/bse_testing/faq.html (last visited Mar. 17, 2005) [hereinafter USDA’s Testing Program].
92. Id.
93. See generally BSE Surveillance Plan, supra note 89.
94. See USDA’s BSE Testing, BSE Test Results,
test_results.html (last visited Oct. 2, 2005).
95. See New BSE Test Results, supra note 28.
96. By this definition, a positive result is inconclusive. This author’s view is that the USDA uses
the term “inconclusive” in order to avoid explaining a positive result. See USDA’s Testing Program,
supra note 91.
97. Id; see also New BSE Results, supra note 28.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
American health and safety were at risk.98 The USDA answered that the
purpose of the testing was to determine the presence of BSE in the
United States in order to formulate a specific plan should BSE be
More specifically, however, consumer groups cited several reasons
to be concerned with the USDA’s testing policy. First, while 478,050
animals appears to be a great number of cattle, it is fewer than 2% of the
animals slaughtered each year.100 Second, while the USDA was testing
animals only more than thirty months old, animals younger than that
with BSE had been found in other countries.101 Third, the USDA’s policy
of allowing producers to select the animals for testing, the voluntary
nature of the testing, and the advance warning to producers whose cattle
would be tested eliminated any random nature of testing which would
ensure true representative sampling.102 Finally, the surveillance program
is a one-time occurrence.103 No testing policy beyond this current program
exists; in contrast, Japan and England test 100% of their slaughtered
In addition, BSE infection itself is biological, not mathematical, and
fits rather poorly into a statistical model.105 No one knows why one cow
is infected while another is not; while the industrial farming model is designed
to regulate and normalize feeding contents and schedules, making
it far more likely that all the cattle in a single place would eat the same
food, be the same age, and have the same origin, the same is not true in
processing plants, where meat from hundreds of cows, even from different
states and countries, can be combined.106 It is virtually impossible for
any model to account for every possible variation and exception when
dealing with living organisms. The USDA seems implicitly to understand
this because it allows that BSE could exist despite no positive results
in the surveillance testing; the surveillance is designed to expose the
chance of BSE, not the actuality of it.107
Meanwhile, while the USDA, industry groups and consumer groups
were busy debating the testing policy, at least two ranchers who were
daily losing money to the Japanese ban on American beef were trying to
create solutions of their own.
98. See Steve Mitchell, Consumer Groups: New Mad Cow Plan Lacking, UNITED PRESS INT’L,
Mar. 16, 2004, available at
99. See USDA’s Testing Program, supra note 91.
100. Cf. Mitchell, supra note 98.
101. See Simon, supra note 88, at A1.
102. See Mitchell, supra note 98.
103. See BSE Surveillance Plan, supra note 89, at 1.
104. See Simon, supra note 88, at A11.
105. See Bovine Spongiform Encephalopathy, supra note 59.
106. See Wendy J. Umberger, Will Consumers Pay a Premium for Country-of-Origin Labeled
Meat?, CHOICES, 4th Quarter, 2004,
(last visited Mar. 17, 2005).
107. See Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States, (last visited Mar. 17, 2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
E. American Producers: Creekstone and Gateway
On February 19, 2004, in response to the Japanese ban on American
beef, Creekstone Farms Premium Beef, LLC (Creekstone) sent an e-mail
to the USDA108 requesting permission to test all of its cattle for BSE, intending
to persuade Japanese customers that its cattle were BSE-free
with a USDA certification.109 A significant percentage of the black angus
cows that Creekstone raised and slaughtered were destined for the Japanese
market, where they fetched a far higher price than was possible in
the American market; a tongue that sold for $3.50 in the United States
sold for $17.00 in Japan.110 Creekstone estimated it was losing $200,000
daily from the Japanese ban, and planned to test all of its 300,000 cattle
for BSE using a $500,000 testing site it had recently built to USDA specifications.
111 The request to the USDA was widely reported in the media;
the first inkling that something untoward was afoot came in a meatingplace.
com article by Daniel Yovich, who reported—before the USDA
had responded to Creekstone’s request—that the 1913 VSTA gave the
USDA authority to prevent unauthorized diagnostic testing.112
On April 8, 2004, Creekstone’s COO and CEO attended a meeting
in Washington, D.C. with USDA Undersecretaries J.B. Penn and Bill
Hawks, and USDA Chief of Staff Dale Moore.113 What the Chief of Staff
told the COO and the CEO of Creekstone surprised them.114 Creekstone
was being denied the authority to test based on three grounds: (1) BSE
testing of animals younger than thirty months old was not scientifically
justified or necessary;115 (2) the BSE test kit was licensed for surveillance
108. Not just anybody can email the USDA requesting policy decisions. Even though Creekstone
was an independent player in the beef market, it was not an insignificant one. See Daniel Yovich,
Creekstone lays plans to test 100 percent, bust through beef ban, MEATINGPLACE.COM, http://www. (last visited Mar. 17, 2005). Bill Fielding, the COO of Creekstone,
is a twenty-six-year veteran in the beef industry. Id. Before joining Creekstone, he had served
as President of the Farmland Industries’ refrigerated foods group, Chairman of the American Meat
Institute, and President of ConAgra Foods’ refrigerated meat group, significant positions with some of
the largest American beef industry players. Id.
109. E-mail from Bill Fielding, COO of Creekstone, to Jim Butler, USDA Deputy Under Secretary
for Farm and Foreign Agricultural Services (February 19, 2004, 04:51 CST) (on file with author).
110. See Donald G. McNeil, Bored From Testing for Mad Cow, Niche Meatpacker Loses Clients,
N.Y. TIMES, April 18, 2004, at 14.
111. See Editorial, A Strange Ban on Testing Beef, N.Y. TIMES, April 18, 2004, at 12.
112. See Yovich, supra note 108.
113. See Interview with Bill Fielding, supra note 39. It is possible that Creekstone and the government
officials knew one another; Dale Moore was the previous executive director for legislative
affairs of the National Cattlemen’s Beef Association. Regardless, Creekstone was an important
enough market player that it was able to have its first meeting in Washington, D.C. with some of the
most powerful and influential figures in the USDA. See supra note 107.
114. See Interview with Bill Fielding, supra note 39.
115. See Cohen et al., supra note 90, at 38.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
purposes only; and (3) the VSTA gave the USDA authority to control
the licensing and use of the BSE test kit.116
Creekstone followed up on the Washington meeting with a letter
dated April 13, 2004, expressing hope that the USDA could find a political
solution to lift the Japanese ban.117 The letter made clear that Creekstone
would consider legal action if the USDA continued to prevent it
from testing.
Meanwhile, in Missouri, a much smaller operation, Gateway Beef
Cooperative (Gateway), representing fifty-eight members that slaughter
about 10,000 cattle a year (compared with Creekstone’s 300,000), also
sent a letter to the USDA, asking to voluntarily test its cattle for BSE.118
Also a producer losing money due to the Japanese ban, Gateway reasoned
that Japanese consumers would pay a premium for BSE-tested
beef.119 Unlike Creekstone, Gateway represented small farmers, many of
whom did not employ the same technology as the larger processors and
slaughterhouses, and many of whom raised their cattle on grass, instead
of in feedlots.120 Also unlike Creekstone, Gateway agreed in advance to
submit to any of the USDA’s demands regarding testing, including methods,
locations, and cost.121 Like Creekstone, however, Gateway saw its
request not as a food-safety measure per se, but rather a marketing tool.
If Gateway could somehow demonstrate to the Japanese market that its
beef was safe, perhaps the ban would be lifted, at least selectively.122
Although the USDA never formally responded to Gateway, it was
clear that the USDA’s answer to Creekstone also applied to them.
Gateway believes the USDA will not allow testing for a number of reasons:
(1) the USDA is afraid that a false positive will significantly disrupt
the economy (according to Gateway, 151 positive BSE tests in Japan resulted
in only 12 confirmed BSE cases); (2) the USDA wants to reach an
independent agreement with Japan; and (3) the USDA insists that cattle
under thirty months old cannot develop BSE.123
On July 27, 2004, the Ranchers-Cattlemen Action Legal Fund,
United Stockgrowers of America (R-CALF), wrote a letter on behalf of
Creekstone and Gateway to USDA Secretary Ann Veneman, urging the
116. See Interview with Bill Fielding, supra note 39; Statement by Bill Hawks, supra note 40; see
also Creekstone Farms to Challenge USDA’s Decision to Decline Private BSE Testing, http://www. (last visited Mar. 17, 2005).
117. See Interview with Bill Fielding, supra note 39.
118. Telephone Interview with John Tarpoff, Manager, Gateway Beef Coop. (June 3, 2004) [hereinafter
Interview with John Tarpoff].
119. See Press Release, Missouri Farmer’s Union, Gateway Beef Requests Permission to Perform
Voluntary BSE Testing (Apr. 30, 2004) (last visited
Mar. 17, 2005).
120. See Interview with John Tarpoff, supra note 118.
121. Id.
122. Id.
123. Id.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
USDA to allow private testing of cattle.124 R-CALF argued that the
USDA is working against American beef producers in opposing testing
while failing to reopen American markets to the world, leaving American
processors unable to meet market demands and standards.125 In addition,
R-CALF noted that the USDA already allows beef processors to
advertise other perceived safety measures, such as meat being addedhormone-
free, and that large American distributors, such as Costco, had
joined the call for voluntary testing of beef. R-CALF further assured the
USDA that Creekstone and Gateway would conform to all USDA protocols
to test their cattle.126 Finally, R-CALF demanded a timeline for
resolution of BSE testing policy, suggesting a deadline of October 1,
On March 2, 2005, in an opinion explored below, the first court to
hear an argument in favor of voluntary BSE testing weighed in on the
debate.128 The court stated that the USDA’s stance against private testing
was “contrary to rational thinking because any private testing would
actually assist in assuring proper testing for animal diseases and increase
consumer confidence, both domestically and internationally, in U.S. cattle
and beef.”129
F. Canadian BSE and Canadian Cattle
It will be helpful here to outline briefly the issues of Canadian cattle
and Canadian BSE because a significant percentage of USDA and consumer
group energy has focused on this area. Many of the same issues—
testing, the feed ban—have been borne out in the context of Canadian
BSE and the American ban on Canadian cattle.
After an outbreak of BSE in Canada in May 2003, the United States
banned imports of all Canadian beef into the United States.130 But the
USDA violated the ban almost as soon as it began. In May 2004, the
USDA admitted it had allowed imports of processed beef into the
United States in September 2003, despite the ongoing ban.131 Between
September 2003 and March 2004, when a federal judge imposed an in-
124. See Letter from Bill Fielding, Chief Operating Officer of Creekstone Farms, Russ Kramer,
Gateway Beef Coop., and Bill Bullard, Chief Executive Officer of R-CALF USA to Ann Veneman,
Secretary of the USDA,
20letter.pdf (last visited Mar. 17, 2005).
125. Id.
126. Id.
127. Id.
128. The true focus of this lawsuit, explored below, was to prevent Canadian beef from entering
the United States; testing of cattle for BSE was a secondary issue. See, e.g., Ranchers Cattlemen Action
Legal Fund United Stockgrowers of Am. (“R-CALF”) v. USDA, 359 F. Supp. 2d 1058 (D. Mont.
2005),rev’d,415 F.3d 1078 (9th Cir. 2005).
129. See R-CALF, 359 F. Supp. 2d at 1072 (granting preliminary injunction).
130. See Veneman, supra note 35.
131. See Kaufman, supra note 36.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
junction on the USDA,132 more than 33 million pounds of beef crossed
the Canadian border in the trucks of American meatpackers, accompanied
by permits signed by the USDA. Even after publicly affirming the
Canadian ban, by declaring that the danger of Canadian ground beef was
so great to American consumers that it could not be allowed into the
United States, Ann Veneman allowed USDA officials to make exceptions
upon finding “that certain products would not pose a health risk
because of risk mitigations.”133
Problems with Canadian beef had barely begun. The USDA announced
in March 2004, that it planned to reverse its ban on Canadian
products, reopen the Canadian border for most beef products, and recategorize
Canada as a “minimal risk” country beginning on March 7,
2005; a final rule confirming reversal on the ban was issued on December
29, 2004,134 despite extensive comments protesting the rule.135 The discovery
of two additional Canadian cows with BSE on January 2, 2005,
and January 11, 2005, raised the Canadian BSE count to four (five if the
Washington cow was counted) and breathed drama into American industry
and consumer fears. Neither discovery caused the USDA to revise or
reconsider Canada’s proposed status as a minimal risk country.136 RCALF
filed suit against the USDA on January 10, 2005.137
The federal district court in which R-CALF filed its suit dealt a significant
blow to the USDA when it granted R-CALF’s request to enjoin
the USDA from opening the Canadian border on March 2, 2005. The
Court found that the USDA’s decision to open the border despite the
new BSE cases would most likely be found arbitrary and capricious because
(1) it failed adequately to assess the impact of its action on human
health; (2) its assumption that the BSE incidence in Canada was very low
was unsupported and demonstrably wrong; (3) its reliance on the Canadian
feed ban was unjustified; (4) it arbitrarily assumed SRM removal
eliminates all risks of BSE; and (5) it failed to respond adequately to
comments suggesting mandatory BSE testing of Canadian Cattle.138 In
addition, the court found the USDA failed to satisfy procedures required
by the National Environmental Policy Act and the Regulatory Flexibility
Act.139 R-CALF’s lawsuit had been supported in amicus curiae briefs
132. See R-CALF v. USDA, No. CV-04-BLG-RFC (D. Mont. May 4, 2004), available at http:// (granting preliminary injunction).
133. See Kaufman, supra note 36.
134. See Bovine Spongiform Encephalopathy, Minimal Risk Regions and Importation of Commodities;
Final Rule and Notice, 70 Fed. Reg. 460 (to be codified at 9 C.F.R. pts. 93, 94, 95, 96).
135. See R-CALF, 359 F. Supp. 2d at 1062 (“Plaintiff and over three thousand others submitted
written comments on the proposal.”).
136. Id. at 1063.
137. See Verified Complaint for Declaratory and Injunctive Relief, R-CALF v. USDA, (D. Mont.
Jan. 9, 2005) (No. cv-05-6-BLG-RFC) available at,%20RCALF%
138. R-CALF, 359 F. Supp. 2d at 1065–69.
139. Id. at 1071, 1073.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
filed by Connecticut, New Mexico, North Dakota, Montana, Nevada,
South Dakota and West Virginia.140
A flurry of activity ensued in the days and weeks following the federal
district court’s grant of the temporary injunction. On March 3, 2005,
the United States Senate voted 52-46 to overturn the USDA’s January
29, 2004, final rule.141 The House of Representatives introduced, but
never voted on, a similar resolution.142 Before the USDA even filed its
appeal with the Ninth Circuit Court of Appeals on March 17, 2005,143 the
National Meat Association (NMA)—whose application to intervene in
the federal district court case was denied144—filed an emergency motion
for an expedited briefing and hearing,145 which the Ninth Circuit Court of
Appeals granted on March 11, 2005.146 On April 21, 2005, a large number
of trade associations, farm bureaus and individual cattle producers jointly
moved to file an amici curiae brief in support of the USDA’s appeal;147
140. Answering Brief of Ranchers Cattlemen Action Legal Fund United Stockgrowers of America
at 5, Nat’l Meat Ass’n v. USDA, No. 05-35214 (9th Cir. July. 29, 2005), available at http://www.rcalfusa.
com/BSE/bse_fmd.htm (follow “Answering Brief of R-CALF USA to NMA’s Intervenor Application”
141. A joint resolution providing for congressional disapproval of the rule submitted by the Department
of Agriculture under chapter 8 of title 5, United States Code, relating to risk zones for introduction
of bovine spongiform encephalopathy. S.J. Res. 4, 109th Cong. (2005), available at http://
142. Disapproving the rule submitted by the Department of Agriculture relating to the establishment
of minimal-risk regions for the introduction of bovine spongiform encephalopathy into the
United States, H.R.J. Res. 23, 109th Cong. (2005), available at
z?d109:HJ00023:@@@X. Perhaps revealing the political nature of the USDA’s position, President
Bush vowed to veto the bill if it passed. See Press Release, Executive Office of the President, Office of
Mgmt. & Budget, Statement of Administration Policy: S.J. Res. 4—Disapproving the Rule of the Department
of Agriculture on Minimal Risk Zones Related to Bovine Spongiform Encephalopathy
(Mar. 3, 2005) (on file with author).
143. See News Release, U.S. Government Requests Appeal In Minimal-Risk Rule Case (Mar. 17,
2005), (follow “Newsroom” hyperlink; then follow “Latest Releases” hyperlink;
then search by date) (last visited Mar. 17, 2005).
144. See R-CALF v. USDA, No. CV-04-51-BLG-RFC, at 4 (D. Mont. Dec. 13, 2004) (order denying
intervention), available at (follow “caut Denres NMA’s
Intervention Request” hyperlink). The USDA also opposed the intervention by the NMA, on the
grounds that the interests of the USDA and the NMA were identical. See Brief for Defendant-
Appellees at 7, R-CALF v. USDA, No. 05-35214 (9th Cir. July 25, 2005), available at http://www.rcalfusa.
com/BSE/bse_fnd.htm (follow “Answering Brief of USDA to NMA’s Intervenor Application”
hyperlink). In addition, the Ninth Circuit Court of Appeals affirmed the federal district court’s denial
of NMA’s application for intervention on July 25, 2005. See R-CALF v. USDA, No. 05-35214, 2005
U.S. Lexis 15448, at *10, Memorandum (9th Cir. July 25, 2005) (on file with author).
145. See Emergency Motion Under Circuit Rule 27-3 at 7, R-CALF v. USDA (9th Cir. Mar. 11,
2005), available at’s%20Emergency%20Motion%20for%20Appeal.
146. See Nat’l Meat Ass’n v. USDA, No. 05-35214 (9th Cir. Mar. 11, 2005), available at http://
147. Filing in support were the American Meat Institute, North American Meat Processors,
Southwestern Meat Association, Eastern Meat Packers Association, American Association of Meat
Processors, National Restaurant Association, and the United Food and Commercial Workers. See
Motion for Leave to File Brief of Amici Curiae American Meat Institute et al., R-CALF v. USDA,
No. 05-35264 (9th Cir. July 25, 2005), available at
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
many more, including the National Cattlemen’s Beef Association, also
filed their own amici curiae briefs on the same day.148
Those filing in support of the USDA were primarily supporting
commercial interests. On June 1, 2005, sixty-seven entities, primarily
not-for-profit organizations representing more than 50 million U.S. consumers,
citizens and agricultural producers, filed a brief of amici curiae in
support of R-CALF.149 While the amici curiae supporting the USDA
represented powerful companies and workers who packed, processed,
sold and purchased beef, the amici curiae supporting R-CALF represented
those who produced and consumed beef, groups with vitally different
On May 9, 2005, R-CALF filed a motion for summary judgment in
the federal district court that had enjoined the USDA from opening the
Canadian border, asking the court to hold unlawful and set aside the
USDA’s December 29, 2004, final rule.150 The USDA followed with its
own motion for summary judgment.151 On July 14, 2005, a three-judge
panel of the Ninth Circuit Court of Appeals stayed the federal district
court’s March 2, 2005, Preliminary Injunction Order, holding that the
preliminary injunction was unwarranted and that R-CALF lacked stand-
148. Filing in support were the National Beef Cattlemen’s Association, American Farm Bureau
Federation, National Pork Producer’s Council, twenty-nine State Cattlemen’s Associations, eighteen
State Farm Bureaus, and nine Individual Cattle Producers. Brief For Amici Curiae National Cattlemen’s
Beef Association et al. Supporting Appellants and Vacatur, R-CALF v. USDA, No. 05-35264
(9th Cir. July 25, 2005), available at,
149. Filing in support were national organizations such as the Consumer Federation of America,
the National Farmers Union, Public Citizen, the Organization for Competitive Markets, Center for
Food Safety, National Catholic Rural Life Conference, National Farmers Organization, the CJD
Foundation, Women Involved in Farm Economics, and Institute for Agriculture and Trade Policy;
regional and state organizations such as the California Farmers Union, Cattle Producers of Washington,
Central Colorado Cattlemen’s Association, Dakota Resource Council, Dakota Rural Action, Illinois
Cattlemen’s Association, Illinois Farmers Union, Independent Cattlemen of Nebraska, Iowa
Farmers Union, Just Food, Kansas Cattlemen’s Association, Kansas Farmer’s Union, Merced-
Mariposa Cattlemen’s Association, Michigan Farmers Union, Minnesota Cattlemen’s Association,
Minnesota Farmers Union, Mississippi Livestock Markets, Missouri Farmers Union, Montana Cattlemen’s
Association, Montana Farmers Union, New England Small Farm Institute, Nebraska Farmers
Union, Nevada Livestock Association, North Dakota Farmers Union, Northern Plains Resource
Council, Oregon Livestock Producers Association, Pennsylvania Farmers Union, Rocky Mountain
Farmers Union, South Dakota Farmers Union, South Dakota Livestock Marketing Association, South
Dakota Stockgrowers Association, South Montana Angus Association, Texas Farmers Union, Utah
Farmers Union, Western Organization of Resource Councils, and Wisconsin Farmers Union; and
twenty local and private organizations. See Brief of Amici Curiae supporting Appelee R-CALF Seeking
to Affirm Preliminary Injunction and Order Striking Down Administrative Ruling, R-CALF v.
USDA, No. 05-35264 (9th Cir. Apr. 21, 2005), available at
150. See Memorandum of Points and Authorities in Support of Plaintiff’s Motion for Summary
Judgment at 39, R-CALF v. USDA, No. CV-05-06-BLG-RFC (D. Mont. May. 9, 2005), available at
151. See Defendants’ Reply in Support of Motion for Summary Judgment, R-CALF, Cause No.
CV-05-06-BLG-RFC (D. Mont. July 13, 2005), available at
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ing for a NEPA challenge.152 In addition, the court found that the district
court failed to abide by the correct deferential standard, and that none of
the five grounds on which the district court based its finding supported its
R-CALF filed a Petition for Rehearing, with Suggestion for Rehearing
En Banc, on September 7, 2005, calling the outcome of the case
of “exceptional national importance” and arguing that the court’s decision
was inconsistent with other decisions in the Ninth Circuit, charging
that the court overlooked or mistook important points of law and fact
and reviewed facts not fully developed below.154
Whether the Ninth Circuit Court of Appeals will agree to a rehearing
is anybody’s guess, as is the result of R-CALF and the USDA’s unanswered
motions for summary judgment in the district court. Regardless
of the outcomes, however, if R-CALF’s amici curiae really represent fifty
million constituents, shouldn’t that voice be strong enough to influence
the USDA? If not, does it mean that industry influence on the USDA
has become unbreakable, or part of a larger anti-regulatory movement?
Was the district court’s awarding of a preliminary injunction an accidental
victory? Has the Ninth Circuit ruling strengthened the USDA, preventing
any chance of a reconsideration of its BSE prevention program?
Can the dicta of the district court be used to pave the way for American
producers to test their own cattle? Should it?
The saga of BSE is contemporary, yet shows no sign of subsiding.
While the Canadian border may be open at the time this note is published,
it seems that regardless of how BSE and the accompanying legal
issues play out, BSE testing continues to be an inadequately addressed
problem of health law, administrative law, and international law. This
section will evaluate the likelihood of further judicial review in the context
of BSE testing, and will analyze in detail the VSTA, the law which
the USDA has used to prohibit Creekstone and Gateway’s voluntary
testing. Mandatory BSE testing, opposed by the largest industry groups,
may or may not be in American agriculture’s future. Voluntary testing,
on the other hand, should be. As the federal district court noted above,
for consumer confidence, market reliability, and testing consistency, opposing
voluntary testing is “contrary to rational thinking.”155
152. See R-CALF v. USDA, No. 05-35264, DC No. CV 05-006 RFC D. Mont. at 23, 50 (9th Cir.
July 14, 2005) (on file with author).
153. Id. at 1096.
154. See Petition for Rehearing, with Suggestion for Rehearing En Banc, R-CALF v. USDA, No.
05-35264, (9th Cir. Oct. 13, 2005) (order denying petition for rehearing).
155. See R-CALF v. USDA, 359 F. Supp. 2d 1058, 1072 (D. Mont. 2005); supra text accompanying
notes 128–29.
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A. USDA Authority and Deference
Before beginning any analysis about the USDA’s authority to regulate
private testing of cattle, establishing the level of deference a court
may show the agency during judicial review is crucial. Whether a court
defers to USDA decisions depends on a number of factors.156 A primary
concern is whether the agency is acting under an unambiguous Congressional
mandate. But also important is whether its decision was made in
an Administrative Procedure Act (APA) formal rulemaking, or an informal
notice-and-comment rulemaking.157 The following paragraphs
will show that because the USDA’s decision to prohibit testing under the
authority of the VSTA was not made under a formal rulemaking, nor any
recognizable informal rulemaking under the APA, nor anything even as
informal as an announcement or press release, the decision should not be
afforded a very high level of deference. In fact, the relatively high “goto”
APA standard of arbitrary or capricious158 on which courts usually
rely in administrative law cases might not be appropriate in the present
case at all. Here, a much lower standard may be warranted.
In 1944, the Supreme Court laid out an initial deference to agency
decision standard, which would last for forty years, in Skidmore v. Swift
& Co.159 Justice Jackson, writing for the Court, held that the deference
accorded to Administrators of agencies in reviewing agency decisions
should include “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.”160 While not the
most specific of standards, it nonetheless lasted until 1984, when Chevron,
U.S.A., Inc. v. Natural Resource Defense Council, Inc.161 was decided.
In Chevron, Justice Stevens set out a standard of judicial review for
agency interpretations of statutes that has become the “central feature of
contemporary administrative law argumentation”;162 if Congress has spoken
directly, its intent must be followed.163 If Congress is silent or ambiguous,
the court should consider the agency’s interpretation to be a
valid statutory construction, unless it is “arbitrary, capricious or manifestly
contrary to the statute.”164 In essence, the standard is agency reasonableness.
165 For twenty years, this almost unbeatable standard de-
156. See U.S. v. Mead Corp., 533 U.S. 218, 228 (2001) (citing Skidmore v. Swift & Co., 323 U.S.
134, 139–40 (1994).
157. Administrative Procedure Act, 5 U.S.C. §§ 554–557 (2001).
158. 5 U.S.C. § 706(2)(A) (2001).
159. See Skidmore, 323 U.S. at 139–40.
160. Id. at 140.
161. 467 U.S. 837, 842–45 (1984).
802 (5th ed. 2003).
163. See Chevron, 467 U.S. at 842–43.
164. Id. at 844.
165. See United States v. Mead Corp., 533 U.S. 218, 229 (2001).
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fined, and continues to define, the landscape of administrative law. Yet
this standard is problematic because an agency could read almost any
statute and find an interpretation to suit its goals.166
In the twenty years since Chevron, the Supreme Court has redefined
its position on agency statutory interpretation. In perhaps the most
significant case since then, U.S. v. Mead Corp.,167 the Court noted “[t]he
fair measure of deference to an agency administering its own statute has
been understood to vary with circumstances, and courts have looked to
the degree of the agency’s care, its consistency, formality, and relative
expertness, and to the persuasiveness of the agency’s position.”168 In
other words, Chevron’s reasonableness cannot and should not be the sole
test for the validity of an agency statutory interpretation. The Court also
noted that Chevron did not eliminate Skidmore’s holding that “an
agency’s interpretation may merit some deference whatever its form,
given the specialized experience and broader investigations and information
available to the agency and given the value of uniformity in its administrative
and judicial understandings of what a national law requires.”
169 Finally, the Court acknowledged that even though an
“overwhelming number of . . . cases applying Chevron deference” were
reviewing informal rulemaking under the APA, an informal rulemaking
procedure alone did not bar deference.170
In a final broad stroke, Justice Souter concluded that considering
the variety of ways in which administrative rules were promulgated, it
was “simply implausible that Congress intended . . . only two varieties of
administrative action, demanding either . . . Chevron deference or none
at all.”171 Justice Scalia, angrily dissenting, claimed the previous “presumption
of authority in agencies to resolve ambiguity in the statutes
they have been authorized to enforce has been changed to a presumption
of no such authority, which must be overcome by affirmative legislative
intent to the contrary.”172 He called Mead “one of the most significant
opinions ever rendered by the Court dealing with the judicial review of
administrative action. Its consequences will be enormous, and almost
uniformly bad.”173
Have the results been as bad as Scalia predicted? It is probably too
early to tell. But in 2004, in General Dynamics Land Systems, Inc. v.
Cline, the Court held “[e]ven for an agency able to claim all the authority
possible under Chevron, deference to its statutory interpretation is called
for only when the devices of judicial construction have been tried and
166. See MASHAW, supra note 162, at 801.
167. 533 U.S. 218 (2001).
168. Id. at 228 (citing Skidmore v. Swift, 323 U.S. 134, 139–40 (1944)).
169. Id. at 234 (citation omitted) (quoting Skidmore, 323 U.S. at 139).
170. Id. at 230–31.
171. Id. at 236.
172. Id. at 239 (Scalia, J., dissenting).
173. Id. at 261 (Scalia, J., dissenting).
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found to yield no clear sense of congressional intent.”174 And in another
vein, in 2000, Justice Thomas found in Christensen v. Harris County that
“interpretations such as [opinion letters]—like interpretations contained
in policy statements . . . which lack the force of law—do not warrant
Chevron-style deference.”175
In light of these decisions, various outcomes emerge when predicting
what standard of review a court might assign to the USDA’s application
of VSTA to BSE testing. One, because the USDA’s decision to
prohibit testing was not carried out under any formal or informal rulemaking,
it may not be entitled to Chevron deference. Two, because the
USDA may not be entitled to Chevron deference, the USDA may be
held to a standard higher than reasonableness to defend its interpretation.
Three, if the Chevron standard does not apply, the appropriate
standard may be a de novo standard under Mead, although accorded
some weight under Skidmore. Keeping these possibilities in mind, the
following section will analyze the VSTA, assessing the USDA’s authority
to regulate BSE testing by examining the legislative history, the text of
the statute, other court interpretations, and at length, the plain language
of the statute. The analysis will conclude that BSE testing is not within
the USDA’s authority under the VSTA.
B. The Virus, Serum, and Toxin Act; Legislative History
In R-CALF v. USDA, the counsel for the USDA confirmed that the
BSE test is “licensed by USDA under the Virus-Serum-Toxin Act.”176
There is no question that the VSTA is the authority under which the
USDA licensed the test; the issue is whether the VSTA gives the USDA
authority to license the test and prevent private producers from testing
their own cattle. While the hearings in the Montana federal district court
were not the first time VSTA had been quoted as the source of the prohibition
against Creekstone and Gateway, it was the first time it had
been used that way in a court of law.177
The VSTA was originally enacted in 1913 as the USDA’s response
to anti-hog-cholera serum causing losses to American hog farmers.178
Congress envisioned the VSTA as a prevention against
dangerous and worthless viruses, serums and analogous products
for use in the treatment of domestic animals, some of which products
may be the means of introducing disease not now known in the
174. See Gen. Dynamics Land Sys., Inc. v. Cline, 540 U.S. 581, 583 (2004) (citing INS v. Cardoza-
Fonseca, 480 U.S. 421, 446 (1987)).
175. See Christensen v. Harris County, 529 U.S. 576, 587 (2000).
176. Transcript of Hearing on Application for Preliminary Injunction at 72, R-CALF v. USDA,
359 F. Supp. 2d 1058 (D. Mont. March 2, 2005) (No. CV-05-06-BLG-RFC), available at http://www.rcalfusa.
com/BSE/Hearing%20Transcript.pdf. [hereinafter Transcript of Hearing].
177. See infra notes 190–92 and accompanying text.
178. See Hall v. State, 158 N.W. 362, 363 (Neb. 1916).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
United States, [as well as] controlling the use . . . of similar dangerous
and worthless products that may be manufactured within the
United States.179
In a later 1913 Congressional hearing, the USDA claimed the VSTA was
designed to “protect the farmer and stock raiser from improperly made
and prepared serums, toxins and viruses.”180
The VSTA was amended in 1985 to grant the USDA authority to
regulate intrastate vaccines.181 In legislative history, the VSTA is described
as the “statutory authority for [the USDA’s] regulation of animal
vaccines and related products,” ensuring “an ample supply of safe and
effective animal vaccines and other biological products” to the American
public.182 The VSTA was again referenced in 2002, in the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.
Here, the VSTA is described as the act under which the USDA regulates
“dangerous agents.”183
C. Text of the VSTA
The VSTA provides, in pertinent part, that it is unlawful to
prepare, sell, barter, or exchange . . . any worthless, contaminated,
dangerous, or harmful virus, serum, toxin, or analogous product intended
for use in the treatment of domestic animals [unless it was]
prepared . . . in compliance with regulations prescribed by the Secretary
of Agriculture, at an establishment holding [a] . . . license issued
by the Secretary of Agriculture.184
The VSTA further authorizes the Secretary of Agriculture to establish
“rules and regulations as may be necessary to prevent the preparation,
sale, barter, exchange, or shipment as aforesaid of any worthless,
contaminated, dangerous, or harmful virus, serum, toxin, or analogous
product for use in the treatment of domestic animals” as well as the ability
to “issue, suspend, and revoke licenses for the maintenance of establishments
for [that] preparation.”185
Importantly, the statute fails to define “virus, serum, toxin, or
analogous product” or any other key terms, heightening the question of
whether the USDA can regulate the BSE test under this statute.186 Adding
a layer of complexity, the statute further permits the Secretary to
179. See S. REP. NO. 62-1288, at 2 (1913).
180. Hearing before the Committee on Agriculture on the Estimates of Appropriations for the Fiscal
Year Ending June 30, 1914, H.R. 28283, 62d Cong. 24 (1913) (statement of Dr. A.M. Farrington,
Asst. Chief, Bureau of Animal Indus., Dept. of Agric.).
181. See Food Security Act of 1985, Pub. L. No. 99-198, § 1768, 99 Stat. 1654–56 (1985).
182. See S. REP. NO. 99-145, at 338 (1985).
183. See Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub.
L. No. 107-188, § 201 at 51 (2002).
184. 21 U.S.C. § 151 (2000).
185. 21 U.S.C. § 154 (2000).
186. See id.
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make and promulgate regulations through the Code of Federal Regulations
(C.F.R.); the Animal and Plant Health Inspection Services
(APHIS), an agency within the USDA, is responsible for the BSE regulations.
187 The corresponding C.F.R. section does not define viruses, serums,
toxins or analogous products, but incorporates all of them in its
definition of biological products. “[B]iological products . . . shall mean
all viruses, serums, toxins . . . or analogous products at any stage of production,
shipment, distribution, or sale, . . . 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.”188 A long list of examples of biological products follows,
including “diagnostic components, that are of natural or synthetic
origin, or that are derived from synthesizing or altering various substances
or components of substances such as . . . proteins, antigens, allergens,
or antibodies.”189
Is the BSE test a virus, serum, toxin, or analogous product? Is it intended
for use in the treatment of animals and does it act primarily
through the immune system? Since neither the text of the statute, the
legislative history, and the APHIS regulations do not clearly answer
these questions, the analysis will continue by examining the VSTA in the
same way a court would: looking at previous court interpretations and
examining the plain language.
D. Court Interpretation of the VSTA
In seven circuits since 1913, courts have evaluated the VSTA as a
statutory tool to regulate vaccines.190 The case which is widely
187. Id.; see also Animal and Plant Health Inspection Services Overview,
(follow “Agencies and Offices” hyperlink; then follow “Animal and Plant Health Inspection Service
(APHIS)” hyperlink) (last visited Feb. 28, 2006).
188. 9 C.F.R. § 101.2 (2005).
189. 9 C.F.R. § 101.2 (2005).
190. See, e.g., Silvey v. Mallinckrodt, Inc., 976 S.W.2d 497, 499 (8th Cir. 1998) (“In enacting VSTA
Congress required that all animal vaccines produced in the United States and all establishments that
manufacture such vaccines be licensed by the USDA.”); United States v. Algon Chem. Inc., 879 F.2d
1154, 1163 n.5 (3d Cir. 1989) (“The VSTA is a separate act of Congress enacted in 1913 and amended
in 1985, which governs the regulation of ‘biologic’ drugs, including serums, vaccines, toxins or antitoxins
that are intended for use in the treatment of domestic animals. . . .”); Arnold v. Intervet, Inc., 305
F. Supp. 2d 548, 550 (D. Md. 2003) (“[The] use or administration of animal vaccines have been preempted
by the regulations promulgated by the Department of Agriculture in its exercise of a plenary
authority granted by Congress to regulate the field of animal vaccines.”); Cooper v. United Vaccines,
Inc., 117 F. Supp. 2d 864, 866 (E.D. Wis. 2000) (“The manufacture and sale of animal vaccines are extensively
regulated by the federal government pursuant to the Virus, Serums, Toxins, Antitoxins and
Analogous Products Act.”); Gresham v. Boehringer Ingelheim Animal Health, Inc., Civ. 95-3376, 1996
WL 751126, at *2 (N.D. Ga. Aug. 7, 1996) (“It is undisputed that Congress intended through VSTA to
create nationally uniform standards for the preparation and sale of animal vaccines.”); Murphy v.
SmithKline Beecham Animal Health Group, 898 F. Supp. 811, 817 (D. Kan. 1995) (“The language
used by APHIS is quite broad: the agency pre-empts state requirements ‘regarding the safety, efficacy,
potency or purity’ as well as the labeling of animal vaccines.”); Found. on Economic Trends v.
Lyng, 680 F. Supp. 10, 11 (D. D.C. 1988) (“The United States Department of Agriculture Animal &
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
considered “the leading circuit court decision on the preemptive effect of
federal regulations governing animal vaccines”191 noted that
“APHIS . . . has promulgated an extensive regulatory scheme governing
the design, manufacture, distribution, testing, and labeling of animal vaccines.”
E. Plain Language of the VSTA
To determine the plain meaning of the VSTA, the particular
language of the statute, as well as its design and language as a whole,
should be examined.193 Then, to ascertain the correct interpretation, it
must be decided “whether the language of the statute is clear or arguably
ambiguous.”194 A number of questions, therefore, need to be answered
in order to determine whether the USDA can regulate the BSE test
under the VSTA: (1) Is a test for BSE a “worthless, contaminated, dangerous
or harmful . . . virus, serum, toxin or analogous product” (and
therefore a biological product) which (2) is “intended for use in the
treatment of animals” and (3) “which act[s] primarily through the direct
stimulation, supplementation, enhancement, or modulation of the immune
system or immune response?”195 Finally, (4) is the BSE test a diagnostic
1. Worthless, Contaminated, Dangerous, or Harmful Virus, Serum,
Toxin or Analogous Product (Biological Product)?
Before determining whether the BSE test is worthless, contaminated,
dangerous or harmful, it should first be determined if the BSE test
is a virus, serum, toxin or analogous product. As mentioned above, the
VSTA provides no definitions for these key terms. A search through the
Dictionary Act of the United States Code, which provides general rules
of construction and definitions for various words in the United States
Code, also does not provide definitions of these key terms.197 Case law is
similarly silent.198 The fourth edition of the American Heritage Diction-
Plant Health Inspection Service . . . controls the production and marketing of veterinary medicines
including vaccines through a licensing process under the Virus-Serum-Toxin Act.”). The only other
interpretation of the VSTA by courts was that the VSTA preempted any state laws. See Lynnbrook
Farms v. Smithkline Beecham Corp., 79 F.3d 620, 629 (7th Cir. 1996).
191. Cooper, 117 F. Supp. 2d at 869.
192. Lynnbrook Farms, 79 F.3d at 624. No other interpretation or use of VSTA has appeared in
any court except in the March 2005 oral argument quoted at the beginning of this section. See Transcript
of Hearing, supra note 176, at 72.
193. See K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 291 (1988).
194. Id. at 293 n.4 (Kennedy, J., plurality).
195. 9 C.F.R. § 101.2 (2005).
196. This is the most likely example of a biological product as envisioned by 9 C.F.R. § 101.2.
197. See 1 U.S.C. § 1 (2000).
198. Only one case has addressed the issue of definition under the VSTA, and not directly. In
deciding whether a product was in compliance with the FDA or the VSTA, United States v. Pro-Ag,
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ary of the English Language, however, provides definitions for all of the
key terms in the VSTA. For example, virus is defined as “any of various
simple submicroscopic parasites of plants, animals, and bacteria that often
cause disease and that consist essentially of a core of RNA or DNA
surrounded by a protein coat.”199 Serum is defined as “the clear yellowish
fluid obtained upon separating whole blood into its solid and liquid
components after it has been allowed to clot” or “blood serum from the
tissues of immunized animals, containing antibodies and used to transfer
immunity to another individual” or “watery fluid from animal tissue,
such as that found in edema.”200 A toxin is defined as a “poisonous substance,
especially a protein, that is produced by living cells or organisms
and is capable of causing disease when introduced into the body tissues
but is often also capable of inducing neutralizing antibodies or antitoxins.”
The BSE test is not a parasite, nor a fluid, nor a substance.202 It
perhaps is an examination, analysis, assessment, process or procedure,
none of which are defined, regulated, or mentioned in the VSTA.
APHIS does define analogous products in its regulations, however.
(2) The term analogous products shall include:
(i) Substances, at any stage of production, shipment, distribution,
or sale, which are intended for use in the treatment of animals
and which are similar in function to biological products in that
they act, or are intended to act, through the stimulation, supplementation,
enhancement, or modulation of the immune system
or immune response; or
(ii) Substances, at any stage of production, shipment, distribution,
or sale, which are intended for use in the treatment of animals
through the detection or measurement of antigens, antibodies,
nucleic acids, or immunity; or
(iii) Substances, at any stage of production, shipment, distribution,
or sale, which resemble or are represented as biological
products intended for use in the treatment of animals through
appearance, packaging, labeling, claims (either oral or written),
representations, or through any other means.203
Inc., 968 F.2d 681, 683 (8th Cir. 1992), defined a term under 9 C.F.R. § 101.2. The court declined to
rule on the merits of the claim and made no statement as to the appropriateness of that definition.
200. Id.
201. Id.
202. Id. A substance is “that which has mass and occupies space; matter.” Id. Many of the testing
components may have mass and occupy space, but the test itself, being conceptual and procedural
in nature, does not.
203. 9 C.F.R. § 101.2 (2005).
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The BSE test does not replicate the actions, processes, results or properties
of viruses, toxins or serums.204 The regulations unambiguously are
designed to cover all of the possible permutations and inventions of substances
that act like viruses, serums, toxins or analogous products, i.e..
products that act upon animals and are harmful or dangerous to them.205
It is simply contrary to rational thinking to state that a test that indicates
disease in an animal is harmful or dangerous to the animal.
The title of Section 151 refers to the “preparation and sale of worthless
or harmful products.”206 While titles are not dispositive of the meaning
or intent of a statute, they often are examined in the context of a
statute.207 The clear plain meaning of this statute is to prevent worthless
or harmful products in order to protect American livestock.208 The BSE
test, however, is not a worthless or harmful product because (1) it is used
by the USDA as a valuable indicator of animal disease and (2) it is a
postmortem test, and currently unable to be used otherwise.209 The BSE
test cannot be harmful or dangerous to domestic animals because the test
is performed postmortem.
2. Intended for Use in the Treatment of Animals
The second requirement of the biological product definition is that
the biological product must be intended for use in the treatment of animals.
Treatment means the “prevention, diagnosis, management, or cure
of diseases of animals.”210 As shown above, the test can identify the
presence of BSE. While ultimately the use of the test may lead to prevention
of the disease, the test itself does not accomplish prevention.
Identification, however, is an aspect of diagnosis.211 Based on identification
and a very broad view of this part of the statute, the BSE test could
be interpreted as a treatment, but without being a virus, serum, or toxin,
it will not meet the remainder of the necessary components.
204. See USDA Food Safety and Inspection Service, Fact Sheets Production and Inspection,
asp (last visited Aug. 23, 2005) (describing existing BSE “gold standard” tests as examinations of
sponge-like changes in brain tissue and BSE fibrils).
205. See 21 U.S.C. § 154 (2000); 9 C.F.R. § 101.2 (2005).
206. 21 U.S.C. § 151 (2000).
207. See Bhd. of R.R. Trainmen v. Balt. & Ohio R.R. Co., 331 U.S. 519, 529 (1947) (“For interpretative
purposes, [titles] are of use only when they shed light on some ambiguous word or phrase.
They are but tools available for the resolution of a doubt. But they cannot undo or limit that which the
text makes plain.”)
208. See Hall v. State, 158 N.W. 362, 363 (Neb. 1916).
209. See Robert A. LaBudde, Inside Microbiology: BSE in the USA Redux: How Mad Are We
Getting?, FOOD SAFETY MAGAZINE, Feb.–Mar. 2004, available at
210. 9 C.F.R. § 101.2 (2005).
211. Diagnosis is “[t]he act or process of identifying or determining the nature and cause of a disease
or injury through evaluation of patient history, examination, and review of laboratory data.”
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3. Acting Primarily Through the Immune System
The third requirement of the biological product definition is that it
must “act primarily through the direct stimulation, supplementation, enhancement,
or modulation of the immune system or immune response.”
212 “The immune system consists . . . of a variety of specialized
cells, enzymes, and other serum proteins which are spread throughout
the blood and tissues of the body . . . concentrated within the spleen,
thymus, lymph nodes, bone marrow, blood and parts of other organs and
The BSE test is conducted by using a sample of the dead cattle’s
brain.214 Because removal of the brain sample is a postmortem operation,
and immunity is the ability to resist disease, it is also contrary to rational
thinking to categorize the BSE test as having a direct effect on the
animal’s immune system, which has ceased to function at the time of the
test. Crucially, even BSE itself—not the test, but the disease—fails to
trigger any immune response in cattle.215 Therefore, because the test—
and the disease—do not stimulate, supplement, enhance or modulate the
immune system, the BSE test fails the third part of the definition for being
a biological product.
In review, a plain language view of the VSTA indicates that the
BSE test is not a worthless, contaminated, dangerous or harmful virus,
serum, toxin or analogous product which operates primarily through the
immune system. Even if it is intended for use in the treatment of animals,
it fails the biological product definition. One more question is necessary
before establishing that the BSE test should not be regulatable by
the USDA under the VSTA.
4. Diagnostic Components
The last part of the plain meaning analysis is whether the BSE test
could be a diagnostic component.216 Fully, the question to be answered is
whether the BSE test is a diagnostic component “of natural or synthetic
212. 9 C.F.R. § 101.2 (2005). The presence of the connector “and” after “the treatment of animals,”
in 9 C.F.R. § 101.2 makes it a requirement of this definition that the BSE test acts in this manner.
213. E. J. Richey, The Immune System, University of Florida, Inst. of Food and Agric. Sciences
(Mar. 1997), (last visited Feb. 28, 2006).
214. See Bovine Spongiform Encephalopathy, supra note 59.
215. See Federal Measures to Mitigate BSE Risks: Considerations for Further Action, 69 Fed.
Reg. 13442288, 13442289 (to be codified at 9 C.F.R. pts. 50-85, 9 C.F.R. pts. 309, 310, 311, 318, 319)
(July 14, 2004).
216. 9 C.F.R. § 101.2 (2005). Examining this part of the analysis in this divisive manner can lead
to absurd results. For example, by examining whether the BSE test is a diagnostic component after
concluding that it is likely not a biological product, a possible result is that the BSE test can simultaneously
not be a biological component (by its not being a virus, serum, toxin, or analogous product), but
can be a diagnostic component, and therefore a biological product, without the characteristics of a biological
product. Is this not the definition of statutory ambiguity?
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
origin, or . . . derived from synthesizing or altering various substances or
components of substances such as microorganisms, genes or genetic sequences,
carbohydrates, proteins, antigens, allergens, or antibodies.”217
No definition of “diagnostic components” exists in the APHIS regulations,
nor does the phrase exist in the VSTA itself. In everyday language,
the BSE test is a diagnostic test. But because the BSE test is a series
of procedures and processes, it seems illogical to continue by
analyzing whether the test is of natural or synthetic origin or whether it is
derived from synthesizing or altering substances. The analysis may extend
indefinitely, forcibly separating each of the test’s individual parts,
processes and elements, authorizing the USDA to regulate each part,
process and element individually, a whirlwind of circular reasoning in
which each component of a diagnosis is a diagnostic component, leading
back to the beginning of the analysis. Using the VSTA to regulate the
BSE test requires undeniable expansion of the meaning and purpose of
the statute.
In sum, the USDA cannot regulate the BSE test through the VSTA
because the BSE test is not worthless, contaminated, dangerous or harmful.
The BSE test is not a virus, serum, toxin or analogous product, nor a
biological product. Considering the BSE test as intended for use in the
treatment of animals when it is designed for postmortem use is an overexpansion
of the VSTA. It is likewise a stretch to manipulate the BSE
test and force it into the definition of a diagnostic component (especially
since the diagnostic component is necessarily a biological product) simply
to allow VSTA inclusion. Finally, preventing testing for a disease is
manifestly contrary to a statute whose purpose is to prevent disease. The
USDA, by denying Creekstone and Gateway through application of the
VSTA, sought not to regulate the procedures or substance in each individual
element of the test, but the test itself. In its ninety-two years of
existence, the VSTA has never before been used or interpreted to regulate
testing of any kind. Manipulating the VSTA to include the BSE test
in the age of BSE perverts the statute’s purpose.
The USDA is responsible for the safety of American beef. When it
uses the VSTA to prevent BSE testing, it is limiting its ability to impact
food safety. The use of the VSTA implies a false assumption of authority
that undermines the USDA’s status as a regulator and protector of
American health. Implementing a more comprehensive BSE policy will
serve to strengthen the public’s view of the USDA and food safety and
more importantly, lead to actual protection for Americans from BSE.
217. 9 C.F.R. § 101.2 (2005).
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
A comprehensive BSE testing strategy would ideally create a topdown
approach, beginning with a philosophy of disease prevention and
expanding outward to envelope all of the factors, issues, and circumstances
to achieve the single goal of BSE prevention. The purpose of
BSE testing would be multifold, and include surveillance and food safety
concerns based on accepted scientific methods. All animals scientifically
capable of testing positive for BSE would be tested. Decisions on
whether to open borders would include a thoroughly reviewed plan to
prohibit the entrance—or exit—of BSE. Ideally, private testing would be
a non-issue as well, as USDA testing would be adequate.
In June 2004, a coalition of consumer safety and public interest organizations
compiled a list of recommendations for a comprehensive
BSE testing strategy incorporating many of these concerns.218 If the
USDA were to incorporate these rules into a comprehensive BSE testing
strategy, not only would food safety in the United States be greatly increased,
but a more consistent application of law and policy would be
applied to the BSE problem, allowing producers and consumers accurately
to assess the BSE costs within a balanced and predictable set of
objectives. The following is a list of recommendations, adapted in part
from the coalition noted above. Each of these recommendations would
encourage foreign markets, especially Japan, to reopen their borders to
American beef, satisfying the goals of the beef industry.
1. Test all slaughtered cattle for BSE at 30 months. It is inexcusable
that more than 98% of the cattle slaughtered annually in
the United States never get tested for BSE. Japan tests every
single cow it slaughters—most EU countries test all slaughtered
cattle over thirty months; Germany tests all slaughtered cattle
at twenty-four months.219 The cost to consumers? Six to ten
cents per pound.220 And the current policy of testing downers
doesn’t work either: 2142 (or 0.025%) of 8.5 million symptomless
thirty-month-old cattle in Europe tested for BSE in 2001
were positive.221
218. The coalition of consumer safety and public interest organizations included the Center for
Food Safety, Consumers Union, The Creutzfeldt-Jakob Disease Foundation, Friends of the Earth,
Government Accountability Project, Institute for Agriculture and Trade Policy—Action, and Public
Citizen. See Bush Administration Mad Cow Disease Prevention Report Card, June 22, 2004, available
219. Thomas M. Burton & Martin Fackler, Should U.S. Start to Screen Every Last Cow as in Japan?
‘A Negligible Cost Increase’, WALL ST. J., Jan. 2, 2004, at B1.
220. Id.
221. Id.
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
2. Randomly administer BSE tests to slaughtered cattle starting at
20 months.222 Both England and Japan have discovered animals
younger than thirty months with BSE.223 This would align
USDA policy with Japanese BSE-testing policy and hasten the
reopening of the Japanese market.
3. Test cattle randomly on unannounced visits to slaughterhouses,
feedlots, and anywhere else cattle is raised. The USDA calls
their policy random, but in actuality, BSE tests are announced,
and producers are permitted to select the animals to be
tested.224 While this may save time, it also allows an unacceptable
level of discretion to the producers, who have a strong
economic motive not to have BSE in their herd. Random testing
would be far more representative of the incidence of BSE in
the United States.
4. Congress should require the USDA to license the BSE test. The
USDA should then license the test to private companies that
choose to test their own cattle. The USDA should create standards
for testing conditions and requirements, and promulgate
an application process with objective criteria for private producers.
A standard testing regime would enable private producers
such as Creekstone and Gateway to market their beef as
“tested for BSE.”
5. Ensure feed restrictions are enforced. The FDA has the authority
to enforce the feed ban which prevents rendered cattle from
being fed to cattle. But a February 25, 2005, Government Accountability
Office memo notes that the FDA is far behind on
inspecting feed businesses subject to the feed ban, has no uniform
plan to identify feed businesses, has no routine procedure
for testing of cattle feed, does not require a notice about the
ban to be placed on feed, and has repeatedly failed to notify the
USDA when it discovered that cattle may have been fed
banned feed.225 The need to improve these deficiencies to
lessen the possibility of BSE infection cannot be overstated.
222. See Letter from Jean Halloran, Dir., Food Policy Initiatives, and Michael K. Hansen, Senior
Research Assoc., Consumers Union, to Mike Johanns, Sec’y of Agric., USDA (June 20, 2005) (on file
with author), available at
223. Safer Beef, supra note 9.
224. See Letter from Jean Halloran, Dir. Food Policy Initiatives, and Michael K. Hansen, Senior
Research Assoc., Consumers Union, to Mike Johanns, Sec’y of Agric., USDA (July 25, 2005) (on file
with author).
2005), [hereinafter United States Government Accountability
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
6. Implement a national animal identification and tracking system.
226 Every automobile sold in the United States has a unique
identification number to prevent fraud and insure protection in
the case of a recall. The USDA has acknowledged the need for
a similar system for cattle in the past and held public meetings
to evaluate costs and benefits; as outbreaks of E. coli have
shown,227 the ability to quickly recall infected beef will save
lives. In addition, an identification and tracking system would
not only help to remove tainted meat from store shelves and
storage, but also present an opportunity to fix conditions at the
source which fostered BSE initially.228
7. Give the USDA authority for mandatory recall.229 Most Americans
assume the USDA has the authority to recall infected
meat. In fact, the USDA has never exercised this authority and
regularly withholds information about the sources of infected
meat on the basis that the information is proprietary.230 But the
national animal identification and tracking system will have no
teeth if the USDA cannot exercise the authority to recall meat.
The USDA must confirm with Congress its authority for mandatory
recall.231 This, too, is a food safety measure whose benefits
vastly outweigh its costs.
8. Implement Country of Origin Labeling (COOL). Although required
under the 2002 Farm Bill, COOL remains unenforced
and mired under unnecessary appropriations delays since its
passage.232 Why not give consumers the ability to know the national
origin of their meat and the choice to buy American
9. Increase surveillance for, and implement mandatory reporting
of, Creutzfeldt-Jakob Disease. The objective of BSE testing is
to prevent infected beef from infecting humans, resulting in
CJD, or vCJD, the incurable neurological disease already re-
226. See generally, Michael T. Roberts & Harrison M. Pittman, Legal Issues in Developing a National
Plan for Animal Identification, NAT’L AGRIC. L. CENTER Feb. 2004, http://www. (last visited Oct. 2, 2005).
227. See Sabin Russell, Beef recall process draws criticism; USDA lacks power to inform public,
mandate returns, S.F. CHRON., Jan. 6, 2004, at A15, available at
228. See Editorial, Round 2 for Mad Cow Disease, N.Y. TIMES, July 1, 2005, at A16.
229. See generally, Michael T. Roberts, Anatomy of the Government’s Role in the Recall of Unsafe
Food Products, NAT’L AGRIC. L. CENTER May 2004,
roberts_recall.pdf (last visited Oct. 2, 2005).
230. Russell, supra note 227.
231. See Letter from Michael F. Jacobson & Caroline Smith DeWaal, Dir. Food Safety Program,
Center for Science in the Public Interest, to Ann Veneman, Sec’y, USDA (Jan. 7, 2004) (on file with
author), available at
232. See Jane Kay, The Fish You Buy to Carry a Label This Fall: You’ll Know its Origin and
Whether it’s Wild or Farmed, Feb. 4, 2004, at A1, available at
BERLOWITZ.DOC 4/7/2006 1:05:16 PM
sponsible for the death of more than 160 people in England.233
Tracking the disease would aid BSE prevention from another
angle; mandatory reporting of the disease would enable scientists
to establish the routes of transmission and translate into
better policy for the prevention of the disease.
Each of these recommendations come with costs attached, as do all
regulations. But because beef is ultimately a consumer product, the costs
of improving its safety can, and should, be shared between the USDA,
producers and consumers. More significant are its benefits; the USDA’s
current BSE prevention policy is based on many sound principles, but
has considerable weaknesses which must be resolved. The USDA’s Office
of Inspector General, in August 2004, released a report detailing
many of these shortcomings.234 The Government Accountability Office’s
February 2005 report on the FDA offers another set of sensible recommendations
to improve the BSE policy.235 An inclusive process in which
these government recommendations, the consumer food safety concerns
addressed in part in the above recommendations, and industry concerns
were incorporated into a comprehensive BSE policy would translate into
a successful open foreign market for American beef, and a safer beef
product for all Americans.
BSE is a problem far from under control. A political economy that
prevents the USDA from adequately considering legitimate food safety
concerns must be curtailed; a comprehensive BSE prevention policy incorporating
the recommendations of government agencies, consumer
food safety concerns, and industry interests must be implemented. The
consideration of rational, peer-reviewed science-based research is a
strong foundation for the new comprehensive policy, as are public interest
and industry concerns gathered during a public comment period.
Only after these safeguards ensuring a fair balance between public and
private concerns are in place can the USDA stand confidently behind a
sound BSE policy which is wise, forward-thinking, and substantial.
233. See supra note 8.
PROGRAM-PHASE I (Aug. 18, 2004), available at webdocs/50601-9-final.pdf.
235. United States Government Accountability Office, supra note 225. ...TSS

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