• If you are having problems logging in please use the Contact Us in the lower right hand corner of the forum page for assistance.

US closing BSE lab

Bill

Well-known member
Beef News
USDA to close BSE lab

By Tom Johnston on 2/26/2007 for Meatingplace.com

Saying the prevalence of bovine spongiform encephalopathy in the U.S. cattle herd is "extraordinarily low," and doesn't warrant ongoing costly testing and tracking programs, USDA will shutter the Pacific Northwest's only BSE testing laboratory on March 1.

The Washington State University lab opened after the nation's first BSE case was discovered in nearby Yakima Valley in December 2003, but only two other infected cows have been found, even after the testing of 759,000 animals, including 45,000 in the Northwest.

USDA Spokewoman Andrea McNally told the Associated Press the lack of additional cases spurred the agency's decision to downsize the program and target only 40,000 animals per year. The government plans to close the WSU facility and several others as part of a plan to cut testing by more than 90 percent.

It appears the US will continue to get away with their own 4-D testing program. Divert, Decieve, Deny and Don't test. We know NCBA will applaud this and R-Calf will look the other way despite claims that they support increased testing.

What is sad is that I expect little more than a weak and feeble response from CCA if any.
 

Ben H

Well-known member
Has anyone found these statistics:

ratio of cattle tested to national herd size, percentage of those tested found positive, for both US and Canada.

One may argue that when you test a higher number you will have more positives, true, but you'll also have a lot more negative numbers to dilute those out.

Complete testing isn't economical. I think the large amount of animals tested and the few positives found show that our diet restrictions are effective. The goverment shouldn't be responsible to test every single animal. We as producers spread this disease, not the government. We chose to feed meat and bone meal to cattle in effect making them cannibals. Prions are natures way of preventing cannibalism. Let them do what they're designed to do, eat grass.

Even if the government doesn't want to do all this testing to find that needle in a haystack, the people with the checkbook (buyers) can demand it if it is in fact a problem, and pay a premium for people who pay to test themselves. Then again, if they don't want to a pay a premium they could elect to pay nothing at all for not testing.

More people die from E Coli 0157:H7 then BSE every year. We already know why it's become a problem, but neither government does anything about the source of the problem. E Coli 0157:H7 was spread by Man, raising animals on a diet they weren't designed to eat (high concentrate) has made this strain prevail.
 

Kato

Well-known member
The cattle here must meet the criteria of either being down, diseased, dying, or dead. That alone will increase the odds of finding a positive. Young healthy animals are not qualified to be tested, only higher risk ones. Testing a million healthy slaughter steers that are only 14 months old won't tell you a thing.

It's like looking for whales in Lake Superior. You know you're not going to find them.
 

canadian angus

Well-known member
sort of expected it, in a poler game you have to look like a winner to bluff the masses. Old cattle know better, so just show case the younger ones. Amazing the toothless Oldtimer hasn't made a comment yet. :mad:

CA
 

Econ101

Well-known member
Kato said:
The cattle here must meet the criteria of either being down, diseased, dying, or dead. That alone will increase the odds of finding a positive. Young healthy animals are not qualified to be tested, only higher risk ones. Testing a million healthy slaughter steers that are only 14 months old won't tell you a thing.

It's like looking for whales in Lake Superior. You know you're not going to find them.

I think that was the idea behind denying Creekstone the right to test.

If you don't look, you won't see the dirt.
 

TimH

Well-known member
Econ101 said:
Kato said:
The cattle here must meet the criteria of either being down, diseased, dying, or dead. That alone will increase the odds of finding a positive. Young healthy animals are not qualified to be tested, only higher risk ones. Testing a million healthy slaughter steers that are only 14 months old won't tell you a thing.

It's like looking for whales in Lake Superior. You know you're not going to find them.

I think that was the idea behind denying Creekstone the right to test.

If you don't look, you won't see the dirt.

Econ, was Creekstone planning to test OTM cattle or UTMs ??? :roll:
 

Econ101

Well-known member
TimH said:
Econ101 said:
Kato said:
The cattle here must meet the criteria of either being down, diseased, dying, or dead. That alone will increase the odds of finding a positive. Young healthy animals are not qualified to be tested, only higher risk ones. Testing a million healthy slaughter steers that are only 14 months old won't tell you a thing.

It's like looking for whales in Lake Superior. You know you're not going to find them.

I think that was the idea behind denying Creekstone the right to test.

If you don't look, you won't see the dirt.

Econ, was Creekstone planning to test OTM cattle or UTMs ??? :roll:

I don't know. Does it matter? If Creekstone could have tapped into the Whole Foods Market with their testing they probably would have. Don't U.S. consumers deserve at a minimum we are required to provide to foreign buyers if they pay for it when it comes to ensuring food safety?

The USDA totally overstepped its bounds when it basically declare that it will be final word on food safety through this policy. Johanns can not be sued individually for this policy if it is not fail safe. Neither can the other bureaucrats following along or the political appointees and congressmen who push the policy or allow it to happen. On the other hand, congressmen are still able to obtain money from the industry and industry think tanks (not to mention the full service revolving door policy).

We have Mexicanized our government with this type of corruption of democracy.
 

loomixguy

Well-known member
I can't ever recall when Johanns did one thing for the good of agriculture.

When he was Governor, it was fun to listen to the monthly call in radio show he had, and listen to him waffle and weasel on a lot of the questions asked of him.
 

Judith

Well-known member
I still think that if a blood test is ever developed I would test on my own. (if I was an american producer) It's frightening to think that BSE testing in the states will be shut down. Thank goodness I can purchase beef from Canada.
 

TimH

Well-known member
Econ101 said:
TimH said:
Econ101 said:
I think that was the idea behind denying Creekstone the right to test.

If you don't look, you won't see the dirt.

Econ, was Creekstone planning to test OTM cattle or UTMs ??? :roll:

I don't know. Does it matter?

I rest my case.

Hey Mike, what was the age of the cattle that Creekstone was proposing to test for export to Japan??? :?
 

Mike

Well-known member
Hey Mike, what was the age of the cattle that Creekstone was proposing to test for export to Japan???

Their was no exact predetermined age that I know of. They wanted to test all of them so that age would not be a consideration in the shipping/marketing agreement.

Creekstone is not a "Cull" cattle slaughterer, per se, so I suppose theirs would probably being described as "younger" cattle. Whatever that means.

Had the USDA allowed them testing, the 20 months or younger age now required should not have been a factor.

What's your point?
 

Bill

Well-known member
So where is the out cry from all the R-Klanners who not long ago were making a big to do about Creekstone and testing for export. Remember the song and dance OT, Sadhusker and others gave about R-Calf actually supporting INCREASING THE AMOUNT OF BSE TESTING IN THE US?

:roll: :roll: :lol2:

Anyone care to predict when the first R-Calf press release will be issued denouncing USDA's move (besides never)? It seems they aren't against crawling into bed with the USDA and packers after all if the situation suits them.

Their silence is deafening but also quite telling.
 

TimH

Well-known member
Here is my "point", Mike, if there is one........ Econ's reply to Kato's post once again proves that he doesn't know what he is talking about most of the time. This is so obvious, that "pointing" it out is almost.... redundant!
I wonder if he just craves the attention. :D :D





Econ101 said:
Kato said:
The cattle here must meet the criteria of either being down, diseased, dying, or dead. That alone will increase the odds of finding a positive. Young healthy animals are not qualified to be tested, only higher risk ones. Testing a million healthy slaughter steers that are only 14 months old won't tell you a thing.

It's like looking for whales in Lake Superior. You know you're not going to find them.

I think that was the idea behind denying Creekstone the right to test.

If you don't look, you won't see the dirt.
 

flounder

Well-known member
Subject: Prions spread via the autonomic nervous system from the gut to the central nervous system in cattle incubating BSE
Date: February 28, 2007 at 9:34 am PST

Prions spread via the autonomic nervous system from the gut to the central nervous system in cattle incubating bovine spongiform encephalopathy
Christine Hoffmann, Ute Ziegler, Anne Buschmann, Artur Weber, Leila Kupfer, Anja Oelschlegel, Baerbel Hammerschmidt and Martin H. Groschup

Institute for Novel and Emerging Infectious Diseases, Friedrich-Loeffler-Institut, Boddenblick 5a, 17493 Greifswald-Insel Riems, Germany


Correspondence
Martin H. Groschup
[email protected]

To elucidate the still-unknown pathogenesis of bovine spongiform encephalopathy (BSE), an oral BSE challenge and sequential kill study was carried out on 56 calves. Relevant tissues belonging to the peripheral and central nervous system, as well as to the lymphoreticular tract, from necropsied animals were analysed by highly sensitive immunohistochemistry and immunoblotting techniques to reveal the presence of BSE-associated pathological prion protein (PrPSc) depositions. Our results demonstrate two routes involving the autonomic nervous system through which BSE prions spread by anterograde pathways from the gastrointestinal tract (GIT) to the central nervous system (CNS): (i) via the coeliac and mesenteric ganglion complex, splanchnic nerves and the lumbal/caudal thoracic spinal cord (representing the sympathetic GIT innervation); and (ii) via the Nervus vagus (parasympathetic GIT innervation). The dorsal root ganglia seem to be subsequently affected, so it is likely that BSE prion invasion of the non-autonomic peripheral nervous system (e.g. sciatic nerve) is a secondary retrograde event following prion replication in the CNS. Moreover, BSE-associated PrPSc was already detected in the brainstem of an animal 24 months post-infection, which is 8 months earlier than reported previously. These findings are important for the understanding of BSE pathogenesis and for the development of new diagnostic strategies for this infectious disease.


http://vir.sgmjournals.org/cgi/content/abstract/88/3/1048?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=prion&searchid=1&FIRSTINDEX=0&volume=88&issue=3&resourcetype=HWCIT





> Moreover, BSE-associated PrPSc was already detected in the brainstem of an animal 24 months

> post-infection, which is 8 months earlier than reported previously.


TSS
 

flounder

Well-known member
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
__________________________________________________
)
CREEKSTONE FARMS PREMIUM BEEF, LLC, )
)
Plaintiff, )
)
vs. ) Civil Action No. 06-544 (JR)
)
UNITED STATES DEPARTMENT OF AGRICULTURE, )
and MIKE JOHANNS, IN HIS CAPACITY AS THE )
SECRETARY OF AGRICULTURE, )
)
Defendants. )
_________________________________________________ )
REPLY IN SUPPORT OF PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND
OPPOSITION TO DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 1 of 52

ii
TABLE OF CONTENTS
SUMMARY OF ARGUMENT.........................................................................................1
ARGUMENT......................................................................................................................4
I. THIS COURT HAS JURISDICTION TO HEAR CREEKSTONE’S CLAIMS.4
A. Creekstone’s Claims Are Not Moot. ..............................................................4
B. Creekstone Has Standing To Present Its Claims. ........................................6
II. USDA’S EXPANSIVE INTERPRETATION OF THE VSTA TO APPLY TO
DIAGNOSTIC TESTS AND TO THE USE OF BIOLOGICAL PRODUCTS
IS UNPERSUASIVE AND NOT ENTITLED TO DEFERENCE.....................10
A. The VSTA Is Neither Ambiguous Nor Susceptible to USDA’s
Interpretations...............................................................................................10
1. Regulation of the Use of Biological Products ...............................12
2. Regulation of Diagnostic Tests.......................................................18
B. USDA’s Expansive Interpretation of the VSTA Is Not Entitled to
Deference. ......................................................................................................21
1. No Deference for Interpretations Expanding the Scope of the Agency’s
Authority.............................................................................................21
2. No deference for Statutory Interpretations Not Accompanied by Further
Explication..........................................................................................22
3. Little Deference for Statutory Interpretations that Were Far from
Contemporaneous or Consistent .........................................................25
C. The Reenactment Doctrine Does Not Save USDA’s Unsupported
Interpretation of the VSTA ..........................................................................27
III. USDA LACKS STATUTORY AUTHORITY TO REGULATE BSE TEST KITS
IN PARTICULAR..................................................................................................29
A. BSE Test Kits Are Not “Analogous Products.” ..........................................30
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 2 of 52

iii
B. BSE Test Kits Are Not, and Would Not Be, Used in the Treatment of
Animal Disease ..............................................................................................33
C. BSE Test Kits Are Not Worthless, Contaminated, Dangerous or Harmful.34
IV. USDA’S RESTRICTIONS ON BSE TEST KITS ON ECONOMIC GROUNDS
ARE OUTSIDE ITS AUTHORITY UNDER THE VSTA .................................39
V. USDA IS NOT ENTITLED TO SUMMARY JUDGMENT ..............................45
CONCLUSION ................................................................................................................45
EXHIBIT 1 Supplemental Declaration of John D. Stewart
EXHIBIT 2 Declaration of Boyd R. Oase of Kowalski’s Markets
EXHIBIT 3 Declaration of James R. Kiley of Wild by Nature Markets
EXHIBIT 4 Declaration of Darin Parker of Parker International Inc.
EXHIBIT 5 Declaration of Kyu O Kim of NY-SK Trading, LLC
EXHIBIT 6 Declaration of Steve Erdley of Penn Traffic Company
EXHIBIT 7 Hearing before the Committee on Agriculture on the Estimates of
Appropriations for the Fiscal Year Ending June 30, 1914, H.R. 28283, 62d
Cong. 20-32 (1913) (testimony of Dr. A.M. Farrington, Asst. Chief, Bureau
of Animal Indus., Dept. of Agric.)
EXHIBIT 8 Declaration of Paul W. Brown, M.D.
EXHIBIT 9 Report on the Monitoring and Testing of Ruminants for the Presence of
Transmissible Spongiform Encephalopathy (TSE) in the EU in 2005
EXHIBIT 10 Declaration of Linda A. Detwiler, D.V.M.
EXHIBIT 11 Supervie and Castagliola, “The Unrecognized French BSE Epidemic,” 35
Vet. Res. 349-362 (2004)
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 3 of 52

iv
TABLE OF AUTHORITIES 1
FEDERAL CASES
62 Cases of Jam v. United States, 340 U.S. 593 (1951) ....................................................43
AFL-CIO v. Brock, 835 F.2d 912 (D.C. Cir. 1987) ...........................................................28
*Adamo Wrecking Co. v. United States, 434 U.S. 275 (1978) ..............................22, 23, 26
American Fin. Servs. Ass'n v. FTC, 767 F.2d 957 ), cert. denied, 475 U.S. 1011
(1986 ............................................................................................................................42
American Petroleum Institute v. EPA, 52 F.3d 1113 (D.C. Cir. 1995) .............................11
*Animal Health Institute v. USDA, 487 F. Supp. 376 (D. Colo. 1980) .............................13
Area Transp., Inc. v. Ettinger, 219 F.3d 671 (7th Cir. 2000) ..............................................8
Arnold v. Intervet, Inc., 305 F. Supp. 2d 548 (D. Md. 2003).............................................21
Babbitt v. Sweet Home Chapter of Communities for a Greater Oregon, 515 U.S.
687 (1995)..............................................................................................................15, 28
*Barnett v. Weinberger, 818 F.2d 953 (D.C. Cir. 1987) ...........................23, 24, 26, 27, 28
Better Government Assoc. v. U.S. Dept. of Interior, 780 F.2d 86 (D.C. Cir. 1986) ............5
*Bowen v. Georgetown Univ. Hospital, 488 U.S. 204 (1988)...........................................25
Burlington Northern R.R. Co. v. Surface Transportation Bd., 75 F.3d 685, 688
(D.C. Cir. 1996) ............................................................................................................6
Central Bank of Denver, N.A. v. First Interstate Bank of Denver, N.A., 511 U.S.
164 (1994)....................................................................................................................29
Lorillard v. Pons, 434 U.S. 575 (1978) .............................................................................29
Chevron. Public Citizen, Inc. v. U.S. Dept. of Health and Human Services, 332
F.3d 654 (D.C. Cir. 2003) ....................................................................17, 18, 22, 23, 26
Christensen v. Harris Cty., 529 U.S. 576 (2000)...............................................................25
*City of Chicago v. Environmental Defense Fund, 511 U.S. 328 (1994)....................16, 17
City of New Haven v. HUD, 809 F.2d 900 (D.C. Cir. 1987) ...............................................5
Continental Airlines, Inc. v. U.S. Department of Transportation , 856 F.2d 209
(D.C. Cir. 1988) ...........................................................................................................26
Dolan v. United States Postal Service, 126 S. Ct.1252 (2/22/2006) .................................14
Edward J. DeBartolo Corp. v. Florida Gulf Coast Building & Constr. Trades
Council, 485 U.S. 568 (1988) ......................................................................................44
Engine Mfrs. Ass'n v. EPA, 88 F.3d 1075 (D.C. Cir. 1996)...............................................22
Ethyl Corp. v. EPA, 51 F.3d 1053 (D.C. Cir. 1995) ....................................................11, 22
*ExxonMobil Gas Marketing Co. v. FERC, 297 F.3d 1071 (D.C. Cir. 2002)...................18
*FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) .........................13, 29
Federal National Mortgage Ass'n v. United States, 56 Fed. Cl. 228 (Ct. of Claims
2003) ............................................................................................................................23
*Friends of the Earth, Inc. v. EPA, 446 F.3d 140 (D.C. Cir. 2006) ..................................22
*Friends of the Earth v. Laidlaw, 528 U.S. 167 (2000) ......................................................4
*Garrelts v. Smithkline Beecham Corp., 943 F. Supp. 1023 (N. D. Ia. 1996) ............28, 44
*General American Transp. Corp. v. ICC, 872 F.2d 1048 (DC Circuit 1989) .................28
1 Asterisk denotes authorities principally relied on.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 4 of 52

v
Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002).................................................................8
*Grand Laboratories, Inc. v. Harris, 488 F. Supp. 618, 619 (D.S.D. 1980), rev’d
on other grounds, 660 F.2d 1288 (8th Cir. 1981).........................................................33
Independent Insurance Agents of America, Inc. v. Hawke, 211 F.3d 638 (2000) .............15
International Union, UAW v. Brock, 816 F.2d 761 (D.C. Cir. 1987)................................28
Investment Co. Inst. v. Camp, 401 U.S. 617 (1971) ..........................................................23
*John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 U.S. 86
(1993)..........................................................................................................................22
Kelley v. U.S. EPA, 15 F.3d 1100 (D.C. Cir. 1994), cert. denied, 513 U.S. 1110
(1995)].........................................................................................................................17
Koszola v. F.D.I.C., 393 F.3d 1294 (D.C. Cir. 2005) ........................................................28
Lorillard v. Pons, 434 U.S. 575 (1978) .............................................................................29
*Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) ....................................................7, 8
Lynn Martin v. Occupational Safety and Health Review Commission, 499 U.S.
144 (1991)....................................................................................................................26
McBryde v. Committee To Review Circuit Counsel and Disability Orders, 264
F.3d 52 (D.C. Cir. 2001) ............................................................................................7, 8
*Michigan Citizens for an Independent Press v. Thornburgh, 868 F.2d 1285
(D.C. Cir. 1989) ...........................................................................................................17
Michigan v. EPA, 268 F.3d 1075 (D.C. Cir. 2001)............................................................11
Miller v. AT&T Corp., 250 F.3d 820 (4th Cir. 2001) ........................................................19
*Natural Resources Defense Council v. Reilly, 983 F.2d 259 (D.C. Cir. 1993) ...............22
Pacific Power & Light Co. v. FPC, 184 F.2d 272 (D.C. Cir. 1950)..................................28
PanAmSat Corp. v. F.C.C., 198 F.3d 890 (D.C. Cir. 1999) ..............................................25
Pegram v. Herdrich, 530 U.S. 211 (2000).........................................................................19
Public Citizen, Inc. v. U.S. Dept. of Health and Human Services, 332 F.3d 654,
662 (D.C. Cir. 2003) ...................................................................................................23
*Railway Labor Executives' Ass'n v. National Mediation Bd., 29 F.3d 655, cert.
denied, 514 U.S. 1032 (1995) ................................................................................21, 26
*Railway Labor Executives' Ass'n v. National Mediation Bd., 988 F.2d 133 (D.C.
Cir. 1993), aff'd on rehearing en banc, 29 F.3d 655 (1994), cert. denied, 514
U.S. 1032 (1995)..............................................................................................17, 18, 42
Reno v. Flores, 507 U.S. 292 (1993) .................................................................................11
Rodriguez v. United States, 480 U.S. 522 (1987) ........................................................12, 42
*SEC v. Sloan, 436 U.S. 103 (1978)..................................................................................23
Sea-Land Serv., Inc. v. Dep't of Transp., 137 F.3d 640 (D.C. Cir. 1998)..........................11
Sea Robin Pipeline Co. v. FERC, 127 F.3d 365 (5th Cir. 1997) .......................................14
*Sierra Club v. Morton, 405 U.S. 727 (1972) .....................................................................7
Solid Waste Agency of Northern Cook County v. U.S. Army Corps of Engineers,
531 U.S. 159 (2001).....................................................................................................29
Texas & Pacific Railway Co. v. Pottorff, 291 U.S. 245 (1934) .........................................15
United States v. Mead, 533 U.S. 218 (2001) .....................................................................23
*Whitman v. American Trucking Ass'ns, 531 U.S. 457 (2001)..........................................13
Whitmore v. Arkansas, 495 U.S. 149 (1990) .......................................................................8
STATE CASES
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 5 of 52

vi
*Hall v. Nebraska, 100 Neb. 84, 158 N.W. 362 (1916) ....................................................16
STATUTES
Administrative Procedure Act, 5 U.S.C. § 706(2) .....................................30, 38, 39, 40, 42
Act of July 1, 1902, ch. 1378, 32 Stat. 728..................................................................13, 31
Agricultural Bioterrorism Protection Act of 2002, 7 U.S.C. § 8401 ...........................15, 29
Virus Serum Toxin Act, 21 U.S.C. §§ 151-154......................................................... passim
21 U.S.C. § 151..........................................................................................11, 19, 29, 35, 43
21 U.S.C. § 152................................................................................................11, 19, 25, 29
21 U.S.C. § 153..................................................................................................................25
21 U.S.C. § 154....................................................................................12, 13, 18, 19, 29, 38
28 U.S.C. § 2680(b) ...........................................................................................................14
29 U.S.C. § 2611(11) .........................................................................................................19
P.L. 99-198, 99 Stat. 1654-56 ............................................................................................27
Sections 211-213 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, P.L. 107-188, 116 Stat. 647 .............................................29
REGULATORY MATERIALS
9 C.F.R. Chapter I Subchapter E........................................................................................25
9 C.F.R. § 101.2(2) ..........................................................................................20, 21, 33, 34
9 C.F.R. § 102.5(d) ......................................................................................................12, 39
9 C.F.R. § 104.1 ...........................................................................................................25, 29
29 C.F.R. § 825.114(b) ......................................................................................................19
62 Fed. Reg. 31,326 (June 9, 1997) .............................................................................27, 32
70 Fed. Reg. 460, 461 (Jan. 4, 2005) .................................................................................32
LEGISLATIVE MATERIALS
Hearing before the Committee on Agriculture on the Estimates of Appropriations
for the Fiscal Year Ending June 30, 1914, H.R. 28283, 62d Cong. 20-32
(1913) (Reply Memo Exh. 7).....................................................................................16
S. Rep. No. 99-145.............................................................................................................28
MISCELLANEOUS
OIE Terrestrial Animal Health Code – 2005, Appendix 3.8.4, Surveillance
for Bovine Spongiform Encephalopathy .....................................................................37
Report on the Monitoring and Testing of Ruminants for the Presence of
Transmissible Spongiform Encephalopathy (TSE) in the EU in 2005 ........................35
Supervie and Castagliola, "The Unrecognized French BSE Epidemic," 35 Vet.
Res. 349-362 (2004).....................................................................................................37
2B Sutherland Stat. Constr. § 49.09...................................................................................28
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 6 of 52

SUMMARY OF ARGUMENT
With hardly a word of analysis (prior to this case), the Department of Agriculture
(“USDA”) has interpreted a statute designed to keep companies from producing and marketing
fraudulent vaccines and serums for treatment of diseases in animals as an almost unlimited grant
of authority to restrict or preclude activities related in any way to animal diseases. Even if it were
appropriate to uphold such an action on the basis of post hoc rationalizations of counsel, here
those rationalizations are inconsistent with basic principles of statutory interpretation, often lack
citation or plausible support, and in some instances simply do not make sense even on their face.
For example, USDA’s argument that this case is moot is based entirely on USDA’s
improper characterization of plaintiff Creekstone Farms Premium Beef’s case as solely an
attempt by Creekstone to export beef to Japan. Neither the Complaint, Creekstone’s Motion for
Summary Judgment, nor the Declaration filed by Creekstone’s founder and then-CEO
characterized Creekstone’s claims that narrowly. To the contrary, Creekstone continues to have
strong, valid reasons for wanting to use BSE test kits.
USDA’s claim that Creekstone lacks standing rests on a similarly narrow view of what
this case is about and the relief Creekstone is seeking. Clearly Creekstone, which believes the
benefits to its business of testing all its cattle for BSE warrants the multi-million-dollar cost of
testing, is suffering both economic and non-economic injuries from USDA’s unlawful refusal to
allow Creekstone access to BSE test kits, injuries that this Court obviously could alleviate by
striking down USDA’s restrictions on BSE test kit use.
USDA’s defense of its regulations restricting the use of diagnostic tests, as well as its
actions concerning BSE test kits in particular, is based on a convoluted reading of the simple
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 7 of 52

- 2 -
language of the VSTA and on its observation that Congress did not specifically prohibit USDA
from regulating BSE test kits. But the Supreme Court and the U.S. Court of Appeals for the
District of Columbia have consistently rejected such attempts to find congressional authorization
from the absence of a prohibition. The VSTA on its face does not extend to restrictions on the
use of biological products, nor the restriction of access to diagnostic tests (especially diagnostic
tests, like the BSE test kits at issue here, which do not operate through stimulation of an animal’s
immune system). USDA’s interpretation of the VSTA is not subject to deference, because (1) it
expands the Department’s authority beyond the literal bounds of the statute; (2) it is not a
contemporaneous interpretation of the statute but rather one that USDA invented 60 years later;
(3) USDA’s regulations were not accompanied by any analysis of the VSTA’s statutory language
or legislative history, or really by any explanation; and (4) at least with respect to import permits
and to BSE test kits in particular, USDA’s regulations were not announced in a rulemaking or
any similar formal pronouncement.
But even if USDA’s regulatory authority under the VSTA extended to controlling who
uses biological products, and for what purpose, and to regulating diagnostic tests that operate in a
manner analogous to viruses, serums, or toxins, USDA cannot legally ban all private use of BSE
test kits. First, BSE test kits do not function as “analogous products;” and second, they are not
used in the treatment of an animal disease. (In fact, USDA claims it can bar Creekstone from
using BSE test kits precisely because they are not being used in the treatment of animals.) Third,
using BSE test kits to screen cattle slaughtered for human consumption for BSE hardly makes
them “worthless.” To the contrary, even USDA’s improperly limited view of the benefits of BSE
testing admits that testing can identify carcasses infected with this fatal disease months before the
cattle would have any outward signs of BSE that might keep them out of the food chain. And
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 8 of 52

- 3 -
renowned BSE experts submitting declarations in support of this Reply Memorandum establish
the benefits of more extensive BSE testing, a practice adopted by almost every country in the
world that has been exposed to BSE.
Finally, even assuming that USDA’s regulations were authorized by the VSTA, and
assuming also that USDA could, consistent with the VSTA, assert jurisdiction over the use of
BSE test kits in particular, USDA’s filings in this case now make it clear that USDA is not
really regulating BSE test kits in order to protect animal health or even to protect the economic
well-being of farmers and ranchers. Rather, USDA is trying to protect large meatpackers from
competition that Creekstone and others who want to test will pose. Put another way, USDA
wants to deprive American consumers of the opportunity to buy beef from BSE-tested cattle.
This goal not only is far beyond what Congress authorized in the VSTA, it is contrary to basic
tenets about the role of government to protect competition and foster this nation’s free-market
economy.
For any one of these reasons, Creekstone is entitled to summary judgment on its claims
that USDA’s actions preventing Creekstone from conducting BSE tests on the cattle it
slaughters are beyond USDA’s statutory authority. Moreover, even if the Court were to
determine that Creekstone has not demonstrated that it is entitled to summary judgment on
those claims, that still would not mean that USDA has carried its burden of justifying summary
judgment for USDA on those claims. Nor, of course, would it mean that USDA is entitled to
summary judgment on Creekstone’s third claim: that USDA acted arbitrarily and capriciously
even if it was within its statutory authority—a claim that has yet to be briefed.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 9 of 52

- 4 -
ARGUMENT
I. THIS COURT HAS JURISDICTION TO HEAR CREEKSTONE’S CLAIMS.
A. Creekstone’s Claims Are Not Moot.
USDA’s argument that Creekstone’s claims are moot is easily disposed of. Contrary to
USDA’s misreading of Creekstone’s Complaint, Creekstone’s desire to test voluntarily for BSE
is not limited to gaining access to Japan’s market. In addition to expanding its customer base,
voluntary testing would enable Creekstone to enhance its brand and competitiveness. Creekstone
domestic and international customers will purchase more Creekstone beef, and at a higher price,
if Creekstone can assure those customers that its products come from cattle that were tested for
BSE. Moreover, because of lingering concerns over the safety of U.S. beef, Creekstone and other
U.S beef producers have not been able to recapture market share in the Japanese and Korean
markets—making BSE testing still relevant for those markets.
USDA mistakenly states that “plaintiff’s primary concern is with its ability to sell beef in
the Japanese market.” USDA Consolidated Memorandum in Support of Defendants’ Cross-
Motion for Summary Judgment and in Opposition to Plaintiff’s Motion for Summary Judgment
(“USDA Memo”) at 15. Creekstone’s Complaint and the Supplement Declaration of its former
CEO and current consultant John Stewart make clear that Creekstone is challenging the USDA’s
ban against voluntary testing for BSE, not a foreign government’s trade policy. See Stewart
Supplemental Declaration, Exhibit 1 to this Reply, ¶¶ 2-3, 5, 8. “It is well settled that a
defendant’s voluntary cessation of a challenged practice does not deprive a federal court of its
power to determine the legality of that practice.” Friends of the Earth v. Laidlaw, 528 U.S. 167,
189 (2000). Here, by contrast, there has been no cessation of USDA’s ban on voluntary BSE
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 10 of 52

- 5 -
testing, making mootness not even an issue. By definition, this case is not moot. See Better
Government Assoc. v. U.S. Dept. of Interior, 780 F.2d 86, 91 (D.C. Cir. 1986) (challenges “to the
legality of the standards utilized” by a government agency were not moot where “the utilization
of the guidelines and the regulation . . . has continued,” even though specific claim seeking relief
was moot where agency had granted relief); City of New Haven v. HUD, 809 F.2d 900, 904 (D.C.
Cir. 1987) (same).
Access to the Japanese market is but one component of Creekstone’s desire to conduct
voluntary BSE testing. In addition to Japan, Creekstone wishes to gain access to Korean and
other overseas markets as well as to expand its U.S. sales by offering beef from BSE-tested cattle.
Exh. 1 (Stewart Supp. Decl.) ¶ 2. And beyond access to markets, Creekstone will be able to sell
more beef at higher prices to both its foreign and domestic customers if the beef is from cattle
tested for BSE. Id. ¶¶ 2, 6, 7; Creekstone customer declarations, Exhibits 2- 6. Thus, irrespective
of Japan’s lifting its ban, Creekstone could increase the demand for its beef if it can test for BSE.
In addition, Creekstone’s business model is to sell the finest Angus beef in the world. By
offering its customers beef from BSE-tested cattle, Creekstone intends to reinforce its reputation
for excellence, safety, and superior beef products. See Exh. 1 (Stewart Supp. Decl.) ¶ 8. USDA
concedes this point by admitting that one of its reasons for denying Creekstone permission to test
for BSE is USDA’s concern that Creekstone’s competitors would feel obligated to BSE test as
well lest they be at a disadvantage. See USDA Memo at 52 n.30. USDA’s recognition that
allowing Creekstone to offer customers BSE-tested beef would boost Creekstone’s brand and
provide a competitive edge alone defeats USDA’s mootness argument.
Moreover, despite Japan and Korea lifting their respective U.S. beef bans, Creekstone
(and other U.S. beef producers) still cannot sell as much U.S. beef as before. Exh. 1 (Stewart
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 11 of 52

- 6 -
Supp. Decl.) ¶¶ 2-6 and attachments. This is because Japanese and Korean customers remain
concerned about the safety of U.S. beef. Exh. 1 ¶¶ 3, 4, 6 and attachments. In contrast to U.S.
beef, Japan requires all of its beef to be tested for BSE, and Australia has never had a case of
BSE, putting Creekstone and other U.S. beef producers at a competitive disadvantage. Exhibit 1
¶ 3 and Attach. A. Creekstone’s desire to test for BSE is motivated in part to compete more
effectively for overseas customers, again defeating USDA’s mootness argument.
In sum, there is absolutely nothing about Japan’s lifting its U.S. beef ban that “make it
impossible to grant [Creekstone] effective relief.” USDA Memo at 15, quoting Burlington
Northern R.R. Co. v. Surface Transportation Bd., 75 F.3d 685, 688 (D.C. Cir. 1996) (emphasis
added). The relief Creekstone seeks from this Court is an order permitting it to test for BSE, not
to open or keep open Japan’s beef market. Creekstone has set forth a host of reasons for wanting
to conduct voluntary BSE testing irrespective of Japan resuming U.S. beef imports. USDA’s
mootness argument that “plaintiff’s alleged injury has disappeared” (USDA Memo at 16) is best
understood as an Article III standing challenge. But for the reasons set forth in the next Part, that
challenge also fails.
B. Creekstone Has Standing To Present Its Claims.
USDA claims that Creekstone lacks standing to pursue its claims because (a) Creekstone
has not made a sufficiently concrete demonstration that Creekstone could be selling more beef
and/or at a higher price were it not for USDA preventing Creekstone from testing its cattle for
BSE and (b) Creekstone has not “provided convincing evidence” that being able to test its cattle
for BSE would remedy that injury. USDA Memo at 17.1 USDA misstates Creekstone’s basis for
1 The weakness of USDA’s argument is exposed by its facially untenable claim that Creekstone
“has creatively alleged” this injury in “an attempt to save its case from mootness as a result of
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 12 of 52

- 7 -
standing, misstates the legal standards for standing, and attempts to substitute its own speculation
about consumer demand for Creekstone’s specific information.
Creekstone’s basic injury is that it is prohibited from testing its cattle for BSE in order to
enhance its brand and distinguish Creekstone beef in the marketplace and to fulfill the demands
of its customers, many of whom will buy more beef at higher prices if it is tested for BSE. The
direct cause of that injury is USDA’s unlawful actions, restricting the licensing and permitting of
BSE test kits, preventing the manufacturers of BSE test kits and the Kansas State University
laboratory authorized to conduct BSE testing from cooperating with Creekstone, and refusing to
approve Creekstone’s proposed Hazard Analysis Critical Control Points (HACCP) program for
voluntary BSE testing. Memorandum of Points and Authorities in Support of Plaintiff’s Motion
for Summary Judgment (“Pl. Memo”) at 11-14. This Court can redress Creekstone’s injuries by
invalidating the USDA regulations and actions that prevent Creekstone from BSE testing and by
ordering USDA not to interfere with Creekstone activities that are outside USDA’s jurisdiction.
See Pl. Memo at 2.
USDA argues that Creekstone must show a definite economic injury, and a definite
economic benefit from a ruling in its favor, in order to have standing to challenge the USDA’s
unlawful action. USDA Memo at 17-23. But the law is very clear that economic injury is not the
only kind of injury that establishes standing. See, e.g., Sierra Club v. Morton, 405 U.S. 727, 734-
45 (1972); Lujan v. Defenders of Wildlife, 504 U.S. 555, 562-63 (1992). Indeed, the very case
that USDA principally relies upon in its mootness argument, McBryde v. Committee To Review
Circuit Counsel and Disability Orders…, 264 F.3d 52 (D.C. Cir. 2001), (cited at USDA Memo at
Japan’s recent lifting of its ban against U.S. beef.” USDA Memo at 17. In fact, Japan lifted its
ban on U.S. beef 12 days after Creekstone filed its Motion for Summary Judgment (see USDA
Memo at 16) and four months after Creekstone described this basis for standing in Paragraph 17-
18 and 26 of its Complaint.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 13 of 52

- 8 -
16-17) held that Judge McBryde had standing to challenge a reprimand handed down by the Fifth
Circuit—clearly not an action to remedy an economic injury. Id. at 56-57. USDA makes no
argument, nor could it, that there is anything speculative about Creekstone’s desire to perform
BSE testing on its cattle, or about USDA’s actions that are preventing Creekstone from doing so.2
If USDA’s position were the law, then businesses’ fundamental right to judicial review of
unlawful agency actions would be thwarted. Indeed, in USDA’s view, its refusal to approve a
new vaccine could not be subjected to judicial review because the vaccine manufacturer could
not provide “convincing evidence” that it could sell the vaccine if it were approved!
The law instead, as set down by the Supreme Court, is that a private party aggrieved by
government action directed at it has standing to challenge that action: “When the suit is one
challenging the legality of government action or inaction, the nature and extent of facts that must
be averred (at the summary judgment stage) or proved (at the trial stage) in order to establish
standing depends considerably upon whether the plaintiff is himself an object of the action (or
forgone action) at issue. If he is, there is ordinarily little question that the action or inaction has
caused him injury, and that a judgment preventing or requiring the action will redress it.” Lujan,
504 U.S. at 561.
2 Creekstone’s assertions of injury and redressability thus are not dependent on the actions of
third parties, as USDA assumes. USDA Memo at 19, 22. The cases that USDA cites for its
standing argument all involve indirect claims involving third parties, not attempts to redress
government action directed at the plaintiff. Whitmore v. Arkansas, 495 U.S. 149 (1990),
considered whether a third party could challenge a death sentence imposed on a capital murder
defendant. The injury in Area Transp., Inc. v. Ettinger, 219 F.3d 671, 673 (7th Cir. 2000), rested
on whether, if the Federal Transit Agency issued the order to a competing school bus operator
that the plaintiff sought, the competitor would choose to forego future federal grants. The
plaintiff in Gettman v. DEA, 290 F.3d 430, 435 (D.C. Cir. 2002) hoped that he could sell
consulting services to third parties who would use marijuana if the DEA legalized its use. There
is no comparison at all between Creekstone’s demonstrated interest in pursuing its business plan
involving BSE testing and Mr. Gettman’s “at best reciting injury to his philosophical interest.”
Id. at 435.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 14 of 52

- 9 -
But even if economic injury were necessary to demonstrate standing, there is no question
that Creekstone has suffered and is continuing to suffer economic injury. See Stewart Decl., Pl.
Memo Exh. 1, at ¶¶ 3, 6, 17 (Creekstone has lost about 35% of its revenue due to BSE concerns
and is prepared to spend $6,000,000 per year to perform BSE testing itself to help recover that
lost demand); see also Stewart Supplemental Decl., Exh. 1 to this Reply, at ¶ 4 (Creekstone’s
average sales to Japan in the past two months have been less than one-twentieth of what they
were prior to the discovery of BSE in the United States), ¶ 8. USDA’s purported evidence to the
contrary is both speculative and beside the point. The agency spends pages in its memorandum
arguing about the accuracy or significance of polls that have consistently shown Japanese
consumers to be reluctant to purchase U.S.-origin beef, and a poll of over 75,000 Americans
reporting that more than a third are “very concerned” about BSE. Compare USDA Memo at 18-
22 with Pl. Memo Exh. 1 at ¶¶ 4-5. Yet one of USDA’s own exhibits confirms that “polls show
many Japanese consumers still have some doubts about the safety of the U.S. product and are
reluctant to buy” U.S. beef. USDA Memo Exh. 12. USDA even asserts, bizarrely, that a poll
indicating that 75% of Japanese respondents were unwilling to eat U.S.-origin beef now that BSE
has been found in the United States “does not necessarily suggest that U.S. beef sales in Japan
will fail to return to the levels they were prior to the Japanese ban.” USDA Memo at 20.
Creekstone’s standing to bring this lawsuit does not stand or fall on any poll. The import
of those polls is that they support and confirm Creekstone’s own information regarding the effect
of BSE on U.S. and foreign markets. Whatever the accuracy of these polls, they certainly
influence the thinking of the distributors and retail chains to which Creekstone sells its products,
and they supplement Creekstone’s personal communications with those distributors and with
consumers (and thus are not hearsay because they are offered to show their existence, and not the
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 15 of 52

- 10 -
truth of the reported consumer sentiments). Cf. Exhibits 2-6 (declarations of Creekstone’s
brokers and of supermarket chains). USDA’s speculation that demand for beef will increase
(and, apparently, will be totally unaffected by BSE concerns) cannot defeat direct information
about the market obtained by Creekstone, which of course is an expert in factors affecting
demand for its products. See Pl. Memo Exh. 1 (Stewart Decl.) ¶¶ 4-5, 16-17; Exh. 1 (Stewart
Supplemental Decl.) ¶¶ 2-4.3 While Creekstone’s own declaration ought to suffice, the attached
declarations from Creekstone’s customers that they would purchase more Creekstone beef, and
would pay a higher price, if Creekstone could provide beef from BSE-tested cattle, conclusively
defeat USDA’s speculations and arguments that Creekstone is not suffering injury from the
agency’s test ban. See Exhibits 2 - 6.
II. USDA’S EXPANSIVE INTERPRETATION OF THE VSTA TO APPLY TO
DIAGNOSTIC TESTS AND TO THE USE OF BIOLOGICAL PRODUCTS IS
UNPERSUASIVE AND NOT ENTITLED TO DEFERENCE.
A. The VSTA Is Neither Ambiguous Nor Susceptible to USDA’s Interpretations.
USDA claims that the VSTA authorizes it to control not only the manufacture and sale of
a virus, serum, toxin, or analogous product (which USDA refers to as “biological products”), but
also who may use such biological products and for what purpose. USDA also claims that the
“biological products” that it can regulate the use of include “diagnostic products” like BSE test
kits. But those authorizations cannot be found in the plain language of the VSTA.
USDA has taken a very simple statute, which gives the Department authority to regulate
the manufacture and sale of specific products, and transformed it into a license to control other
products and other kinds of activities. Some of USDA’s ostensible reasons may appear noble –
3 USDA’s assertion that information previously provided by Creekstone does not reflect recent
improvements in the Japanese market is contradicted by Exh. 1 ¶¶ 3-4. Additionally, it ignores
the fact that access to the Korean market is still highly restricted. Exh. 1 ¶¶ 2, 5-6 and Attach. E.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 16 of 52

- 11 -
to benefit public health and welfare – but that kind of generic goal does not give an agency carte
blanche to regulate whatever it wishes.
The law could not be more clear: “Agency authority may not be lightly presumed. ‘Were
courts to presume a delegation of power absent an express withholding of such power, agencies
would enjoy virtually limitless hegemony, a result plainly out of keeping with Chevron and quite
likely with the Constitution as well.’” Michigan v. EPA, 268 F.3d 1075, 1082 (D.C. Cir. 2001)
(quoting Ethyl Corp. v. EPA, 51 F.3d 1053, 1060 (D.C. Cir. 1995). “‘Thus, we will not presume
a delegation of power based solely on the fact that there is not an express withholding of such
power.’” Id. (quoting American Petroleum Institute v. EPA, 52 F.3d 1113, 1120 (D.C. Cir.
1995)).4
“Mere ambiguity in a statute is not evidence of congressional delegation of authority.”
Sea-Land Serv., Inc. v. Dep’t of Transp., 137 F.3d 640, 645 (D.C. Cir. 1998). But in this case,
there is not even ambiguity. The statute states very clearly what products are covered: a “virus,
serum, toxin or analogous product used in the treatment of domestic animals.” 21 U.S.C. § 151.
It states clearly what activities are covered: the preparation, sale, barter, exchange, or importation
of such products. Id. at §§ 151-152. And it states clearly when those activities may be
prohibited: when such products are “worthless, contaminated, dangerous, or harmful”; are not
“prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture,
at an establishment holding an unsuspended and unrevoked license issued by the Secretary of
Agriculture”; or are imported without a permit. Id.
4 USDA’s reliance on Reno v. Flores, 507 US 292, 300-301 (1993), to say that Creekstone must
“demonstrate that ‘no set of circumstances exists under which the regulation would be valid’”
(USDA Memo at 23) is misplaced. In that case, the respondents were not challenging the
regulation’s application in a specific instance, it had not yet been applied in a particular instance,
and there was no record concerning the INS’s interpretation of the regulation. Id. That clearly is
a very different situation than is presented in the instant case.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 17 of 52

- 12 -
The statute simply does not authorize USDA to regulate activities other than the
preparation, sale, barter, exchange, or importation of biological products. It does not say that
USDA can prohibit or regulate the use of a biological product—in this case, who may use it and
for what purpose.5 Nor does the statute authorize regulation of diagnostic tests—products that
are not analogous to a virus, serum, or toxin—just because they are used in the treatment of
animals. Ignoring those simple, albeit inconvenient for USDA, truths, USDA resorts to
(illogical) claims that its actions promote public health and welfare and protect the interests of
ranchers, encouraging this Court to “simplistically…assume[e] that whatever furthers the
statute’s primary objective must be the law.” Rodriguez v. United States, 480 U.S. 522, 526
(1987) (per curiam) (emphasis in original).
1. Regulation of the Use of Biological Products
USDA asserts that its authority in 21 U.S.C. § 154 to issue regulations “as may be
necessary to prevent the preparation, sale, barter, exchange, or shipment… of any worthless,
contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the
treatment of domestic animals” “explicitly authorizes restrictions on the uses for which viruses,
serum, toxins, or analogous products may be prepared, sold, bartered, exchanged, or shipped.…”
USDA Memo at 25. This contention is absurd on its face. Saying that USDA can regulate the
manufacture and sale of products intended for use in the treatment of domestic animals is not the
same as saying USDA can regulate the use of such products. (And indeed, Congress knows well
how to regulate the use of products when it wishes to do so. See Pl. Memo at 24-25, 31-32.)
5 USDA’s assertion that “regulation 102.5(d) is not a direct use restriction on buyers of biological
products” (USDA Memo at 25) is pure semantics (and irrelevant). Without congressional
authorization to regulate how and by whom biological products are used, and for what purpose,
USDA cannot indirectly do so through unlawful limitations in licenses and permits issued to
biological product manufacturers.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 18 of 52

- 13 -
Under USDA’s theory of how the statutory language should be read, if a statute authorized DOT
to regulate seat belts, air bags, and other safety devices intended for use in motor vehicles, DOT
would be authorized to regulate who may drive motor vehicles, and where, as well!
Not surprisingly, USDA offers no case law in support of its unorthodox reading of the
VSTA, nor even any formal interpretation previously published by USDA. The phrase “for use
in the treatment of domestic animals” clearly limits, rather than expands, “virus, serum, toxin, or
analogous product.” Just as clearly, the phrase must have been used in the VSTA to distinguish it
from the Act of July 1, 1902, ch. 1378, 32 Stat. 728, which authorized the Public Health Service
to regulate any “virus, therapeutic serum, toxin, antitoxin, or analogous product...applicable to the
prevention, treatment, or cure of diseases or injuries of man.” See Animal Health Institute v.
USDA, 487 F. Supp. 376, 378-79 (D. Colo. 1980) (VSTA modeled after the 1902 Act).
Contrary to USDA’s theory of statutory construction, authority to regulate a whole new
class of activities, affecting vastly more businesses and individuals, must be found in a clear
statement of congressional delegation of that authority, not in a strained and ungrammatical
interpretation offered by the agency in litigation to justify its desired scope of authority.6
“Congress…does not alter the fundamental details of a regulatory scheme in vague terms or
ancillary provisions—it does not, one might say, hide elephants in mouseholes.” Whitman v.
American Trucking Ass’ns, 531 U.S. 457, 468 (2001); see also FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 159–160 (2000).
Remarkably, USDA also argues that 21 U.S.C. § 154, because it authorizes USDA to
issue regulations “as may be necessary to prevent the preparation, sale, barter, exchange, or
6 Moreover, even if USDA were correct that the phrase “for use in the treatment of domestic
animals” allowed it to regulate how a biological product is used, that still would not authorize
USDA to dictate who may use the product and for what purpose.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 19 of 52

- 14 -
shipment” of worthless or dangerous biological products, “also expands the ability of USDA to
regulate beyond just the ‘preparation, sale, barter, exchange, or shipment’ of products.” USDA
Memo at 26. Once again, USDA offers no case law, legislative history, or even its past
statements or rulemaking interpreting the VSTA to support or explain this contention. USDA
contends that “clearly” restrictions on how a biological products may be used, by whom, and for
what purpose “may be necessary to close loopholes and remove incentives to circumvent
regulations directed at the ‘preparation, sale, barter, exchange, or shipment’ of products.” Id.
Apparently USDA believes that Congress made it a crime not only for a manufacturer to produce
and sell a dangerous biological product, but for a farmer to continue to use such a product, as
well. See id. Quite simply, it is not for USDA to decide to “close loopholes” that Congress
chose not to regulate. Even if there were such a need for this kind of regulation, this supposed
“[n]eed for regulation cannot alone create authority to regulate.” Sea Robin Pipeline Co. v.
FERC, 127 F.3d 365, 371 (5th Cir. 1997).
Over and over, courts have rejected interpretations of a series of words in a statute that go
beyond the scope of the words in the series, as does USDA’s interpretation here. USDA’s claim
of authority to regulate the use of biological products parallels a claim that the Supreme Court
rejected earlier this year: The plaintiff in Dolan v. United States Postal Service, 126 S. Ct. 1252
(Feb. 22, 2006), relied on a provision concerning liability for “loss, miscarriage, and negligent
transmission” of mail, 28 U.S.C. § 2680(b). The Court observed that, since both “loss” and
“miscarriage” “refer to failings in the postal obligation to deliver mail in a timely manner to the
right address, it would be odd if ‘negligent transmission’ swept far more broadly to include
injuries like those alleged here—injuries that happen to be caused by postal employees but
involved neither failure to transmit mail nor damage to its contents.” 126 S. Ct. at 1254.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 20 of 52

- 15 -
Similarly, in this case it would be odd indeed if Congress intended, in authorizing regulation of
the preparation, sale, barter, exchange, or shipment of dangerous or worthless products used to
stimulate or enhance the immune system of animals, to regulate how such products may be used,
by whom, and for what purpose—activities carried out by the users of the products rather than
their manufacturers, and after the products have already been prepared, sold, and shipped.
Texas & Pacific Railway Co. v. Pottorff, 291 U.S. 245, 257-59 (1934), also resembles the
instant case, in that the Court both (a) refused to find that a national bank could expand its
statutory authorization for “banking” to include pledging its assets to secure a private deposit, and
(b) also reasoned that, if that power had been authorized, there would have been no need to
amend the banking statute later to provide a limited power to pledge.7 So, too, in this case the
enactment of the Agricultural Bioterrorism Protection Act of 2002, 7 U.S.C. § 8401, which gave
USDA limited authority to regulate the possession and use of dangerous biological products, is
evidence that the VSTA should not be read to give broad authorization to regulate who may use
biological products and for what purpose (as is the legislative history confirming that Congress
did not believe the VSTA empowered USDA to regulate the use of biological products). Cf. Pl.
Memo at 24-25.8 USDA offers no response to that application of the canon of statutory
construction, followed in Pottorff, to the history of the VSTA and related legislation.
7 As the D.C. Circuit observed in Independent Insurance Agents of America, Inc. v. Hawke, 211
F.3d 638 (2000), “[t]he pre-Chevron vintage of Pottorff is irrelevant,” since the Supreme Court
had already made clear at that time that decisions of the Comptroller of the Currency were
generally entitled to deference.
8 Cf. Babbitt v. Sweet Home Chapter of Communities for a Greater Oregon, 515 U.S. 687, 696-
701 (1995) (fact that Congress in 1982 authorized the issuance of permits for “incidental take” of
endangered species is strong evidence that Congress understood the preexisting statutory
prohibition on “take” of endangered species to include indirect as well as direct “take”).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 21 of 52

- 16 -
USDA does offer one reference to legislative history of the VSTA that mentions use of
biological products. USDA Memo at 31.9 But that mention of use, put into context, in no way
suggests that Congress meant to include regulatory authority over how a biological product may
be used or by whom. Rather, the passage refers to “controlling the use” of dangerous and
worthless viruses, serum, and analogous products “by preventing the interstate shipment” of such
products that may be manufactured within the United States. The focus of the passage from the
Senate Report, like the focus of the statutory language that Congress ultimately adopted, is not on
how biological products are used, or by whom, but on regulating the manufacture, sale, and
shipment of dangerous or worthless products.10 In any event, this phrase from the Senate Report
could not endow USDA with authority not set out forth the statute. 11
USDA asks this Court to ignore the venerable principle expressio unius est exclusio
alterius, on the grounds that the “principle does not contemplate the expansive phrases ‘for use in
9 USDA also refers to “ubsequent legislative commentary,” by which it means its own 1997
description of the VSTA. USDA Memo at 31. But it is hard to see how the passage from a
USDA Federal Register notice that USDA quoted, that the “main purpose of VSTA is to protect
those who use veterinary products from products which are worthless, contaminated, dangerous,
or harmful” in any way justifies USDA’s conclusion here that “[c]learly the use restrictions
contemplated by regulation 102.5(d) are consistent with the purposes of VSTA.” See USDA
Memo at 31. What should be clear from that passage instead is that the purpose of the VSTA is
to protect those who use biological products from harmful or worthless products, not to regulate
and constrain those who use biological products.
10 Cf. Exhibit 7 at 23-25 (USDA official explaining request for authority over toxins and viruses,
with no mention of restricting who could use toxins and viruses or regulating diagnostic
products); Hall v. Nebraska, 100 Neb. 84, 88-89, 158 N.W. 362, 363-64 (1916) (“We do not
understand that the federal government undertakes to regulate those who sell serum after it has
been disposed of by the manufacturer.”)
11 See City of Chicago v. Environmental Defense Fund, 511 U.S. 328, 337 (1994) (where Senate
Committee report included statement that “all waste management activities of such a facility,
including the generation, transportation, treatment, storage and disposal of waste shall be covered
by the exclusion,” Court declined to find that waste generation was excluded, because “it is the
statute, and not the Committee Report, which is the authoritative expression of the law, and the
statute prominently omits reference to generation.”). Moreover, the “controlling the use” phrase
in the Senate Report relates only to domestic manufacture of products, and not to those that are
imported into the United States, like Bio-Rad’s BSE tests. Cf. USDA Memo at 30-31.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 22 of 52

- 17 -
the treatment of domestic animals’ or ‘as may be necessary to prevent’ modifiers of the list of
items….” USDA Memo at 26-27. USDA offers no authority for this claimed corollary to the
principle, nor any further explanation why it would be that phrases that make the list more
specific or otherwise qualify it would suggest that Congress did not intend the agency’s authority
to be limited to the enumerated list of items or activities. This Court should reject USDA’s
unsupported attempts to expand its jurisdiction beyond the authorities enumerated in the VSTA,
just as other courts have consistently rejected agency claims that authority to regulate one thing
implies authority to regulate something else, because it would be consistent with or helpful to the
stated or intended purposes of the statute. See, e.g., City of Chicago, 511 U.S. at 329, supra n.11;
Railway Labor Executives’ Ass’n v. National Mediation Bd., 988 F.2d 133, 139 (D.C. Cir. 1993),
aff’d on rehearing en banc, 29 F.3d 655 (1994), cert. denied, 514 U.S. 1032 (1995) (Board
cannot assume duties not given to it by Congress); Michigan Citizens for an Independent Press v.
Thornburgh, 868 F.2d 1285, 1293 (D.C. Cir. 1989) (canon of expressio unius est exclusio alterius
can determine whether statute is clear, and therefore no need to resort to Chevron deference).12
Arrogating to itself regulatory authority over a whole different set of activities, conducted
by a different group of people, is simply not the kind of necessary filling of ‘gaps” in a statute’s
regulatory scheme that Chevron contemplated. Cf. USDA Memo at 36. The “mere existence of
an agency does not give it the power to assert authority that Congress has not delegated. It is
absurd to suggest that, under the second prong of Chevron, there is a statutory ‘gap to fill’ or a
12 USDA disputes the relevance of Kelley v. U.S. EPA, 15 F.3d 1100 (D.C. Cir. 1994), cert.
denied, 513 U.S. 1110 (1995). USDA Memo at 27 n. 13. The citation Creekstone provided in its
Memo in Support was, unfortunately, incorrectly limited (citing to p. 1108 rather than pp. 1106-
1108). But the case indeed is relevant as an example of how courts look to the list of things a
statute has authorized an agency to do and decline to find statutory authority for the agency to
regulate in additional areas (in that case, specifying who will be subject to statutory liability for
hazardous waste cleanup).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 23 of 52

- 18 -
statutory ‘ambiguity’ to cure whenever a statute fails to specify some authority that an agency
seeks to invoke. This cannot be the meaning of Chevron, for it would allow federal agencies to
claim limitless authority except in those few circumstances where Congress has expressly said
‘thou shalt not’ exercise such authority.” Railway Labor Executives’ Ass’n, 988 F.2d at 194
(Edwards, J., concurring).
2. Regulation of Diagnostic Tests
USDA admits that the VSTA says nothing about regulating diagnostic products (USDA
Memo at 35), but “neither does it specifically exclude such tests from its purview.” Id. at 36.
The latter is true, but it falls short of authorizing USDA’s regulation of diagnostic tests. The
Supreme Court and the D.C. Circuit have repeatedly admonished regulatory agencies that
statutory authority for an agency to act “may not be presumed based solely on the fact there is not
an express withholding of jurisdiction.” ExxonMobil Gas Marketing Co. v. FERC, 297 F.3d
1071, 1088 (D.C. Cir. 2002).
The interpretation of the VSTA that USDA advances for purposes of this lawsuit is that
“diagnostic products are certainly used in the treatment of animals, which is all that is required
under section 154 of VSTA.” USDA Memo at 37. Again, USDA vastly overstates the meaning
of the qualifier “intended for use in the treatment of domestic animals,” appearing to suggest that
anything broadly defined as “treatment” is therefore regulated under the VSTA. Moreover, even
if Congress had given USDA authority to regulate a product just because it is used in the
“treatment of domestic animals,” that would not include authority to regulate products that are
used solely to detect a disease (and especially those, such as BSE test kits, used solely to detect
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 24 of 52

- 19 -
infection in dead animals).13 The cases USDA cites (USDA Memo at 41) provide no support for
its position: Pegram v. Herdrich, 530 U.S. 211, 228 (2000) contains a discussion of two types of
actions by HMO administrators: “eligibility decisions,” which concern whether a particular
condition or medical procedure for its treatment is covered by the patient’s health insurance plan,
and “treatment decisions,” which “are choices about how to go about diagnosing and treating a
patient’s condition: given a patient’s constellation of symptoms, what is the appropriate medical
response?” Id. Not only to did the Pegram court not define “treatment,” but it used the terms
“diagnosing” and “treating” as if they are two different types of activities, joined by the
conjunction “and.” Nor does Miller v. AT&T Corp., 250 F.3d 820, 830-31 (4th Cir. 2001),
contain any independent analysis of the meaning of the word “treatment”—it merely applies a
Family and Medical Leave Act regulation, 29 C.F.R. § 825.114(b), which defines “treatment” to
include “examinations to determine if a serious health condition exists and evaluations of the
condition,” and defers to an agency determination that the statutory phrase “continuing treatment
by a health care provider,” 29 U.S.C. § 2611(11), is broad enough to cover such examinations.
This is a far different question than whether Congress meant for “virus, serum, toxin, or
analogous product used in the treatment of domestic animals” to include a test procedure and
reagents used to determine whether an animal has (or had) a disease.
Additionally, to be susceptible to regulation under the VSTA, a diagnostic product would
have to be both a “virus, serum, toxin, or analogous product” and “used in the treatment of
domestic animals.” 21 U.S.C. §§ 151, 152, 154. Something is not “analogous” to a virus, serum,
13 USDA claims its open-ended regulation of diagnostic products is justified because the VSTA
refers to viruses, serums, toxins, or analogous products “for use in the treatment of domestic
animals,” rather than “for treatment of domestic animals.” USDA Memo at 37. USDA does not
explain how a biological product that is not “for treatment of domestic animals” could be “used
in the treatment of domestic animals.” Creekstone suggest that to the extent there is a distinction,
though it seems unlikely there could be, it is a distinction without a difference.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 25 of 52

- 20 -
or toxin just because it is “used in the treatment of domestic animals,” but that is what USDA
seems to assume. In USDA’s expansive view of the VSTA’s targeted language, presumably
even a thermometer could be regulated under the VSTA, simply because it is “used in the
treatment of domestic animals.” USDA’s attempt to turn a limiting qualifier into a very broad
congressional delegation of regulatory authority is simply not borne out by the language or
legislative history of the VSTA.14
USDA regulations state that “biological products,” include vaccines, antibodies,
antitoxins, immunostimulants, “and diagnostic components, that are of natural or synthetic origin,
or that are derived from synthesizing or altering various substances or components of
substances….” 9 C.F.R. § 101.2. Read literally, a “diagnostic component” (an undefined term)
need not have anything to do with the defining characteristic of “viruses, serum, toxins, or
analogous products,” which is that they “act primarily through the direct stimulation,
supplementation, enhancement, or modulation of the immune system or immune response.”15
Similarly, USDA defines “analogous products” to include either “ubstances…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 ubstances… which are intended for use in the treatment of animals through the
detection or measurement of antigens, antibodies, nucleic acids, or immunity;…” Id. (emphasis
added). Thus, USDA has explicitly de-coupled these diagnostic tests from any requirement that
14 It also conflicts with a number of more-specific statutory authorities over diagnostic tests,
including the Food, Drug and Cosmetic Act, as noted in Pl. Memo at 31-32, 38 n.14.
15 9 C.F.R. § 101.2 (definition of “biological products”). USDA offers no response to the fact
that USDA has, in other regulations, made a clear distinction between products that operate
through an immune response—and are subject to regulation under the VSTA—and those that do
not, even if the same or similar components are involved. See Pl. Memo at 36, 38.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 26 of 52

- 21 -
they be similar in function to the viruses, serum, toxins, and analogous products that VSTA by its
terms covers.
Under the interpretation of “analogous product” advanced by USDA’s counsel, if
Congress authorized the Department of Transportation to regulate the manufacture and
distribution in commerce of automobiles, motorcycles, trucks, and analogous products, DOT
could regulate the construction (and use) of highways or racetracks, as well. The definitions in 9
C.F.R. § 101.2 do not represent “gap-filling” of an ambiguous statute. Rather USDA’s “position
in this case amounts to the bare suggestion that it possesses plenary authority to act within a
given area simply because Congress has endowed it with some authority to act in that area.”16
See Railway Labor Executives’ Ass’n v. National Mediation Bd., 29 F.3d 655, 671 (D.C. Cir.
1994) (en banc), cert. denied, 514 U.S. 1032 (1995). The D.C. Circuit has “categorically
reject[ed] that suggestion.” Id.
B. USDA’s Expansive Interpretation of the VSTA Is Not Entitled to Deference.
USDA claims that its interpretations of the VSTA as authorizing it to regulate types of
products and activities not addressed in the statute are entitled to great deference. But USDA
cannot overcome the large body of precedent rejecting just such claims by agencies seeking to
expand the authority granted to them by Congress.
1. No Deference for Interpretations Expanding the Scope of the Agency’s
Authority
16 USDA cites an opinion of the District Court for the District of Maryland which described
USDA as having “plenary authority granted by Congress to regulate the field of animal
vaccines.” USDA Memo at 27, quoting Arnold v. Intervet, Inc., 305 F. Supp. 2d 548, 550 (D.
Md. 2003). But the question there was whether USDA’s regulatory authority to approve and
regulate the manufacture of animal vaccines preempted state tort law claims against vaccine
manufacturers, not whether USDA has authority to regulate everything remotely related to animal
vaccines. Even “plenary authority” to regulate the field of animal vaccines does not on its face
imply authority to regulate tests for detecting animal diseases.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 27 of 52

- 22 -
USDA virtually ignores the extensive precedent declining to accord any deference to an
agency interpretation of a statute that gives itself expanded authority. See Pl. Memo at 27; see
also John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 U.S. 86, 108-109, (1993);
Natural Resources Defense Council v. Reilly, 983 F.2d 259, 266 (D.C. Cir. 1993). An agency
simply “may not ‘avoid the Congressional intent clearly expressed in the text simply by asserting
that its preferred approach would be
 

flounder

Well-known member
USDA virtually ignores the extensive precedent declining to accord any deference to an
agency interpretation of a statute that gives itself expanded authority. See Pl. Memo at 27; see
also John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 U.S. 86, 108-109, (1993);
Natural Resources Defense Council v. Reilly, 983 F.2d 259, 266 (D.C. Cir. 1993). An agency
simply “may not ‘avoid the Congressional intent clearly expressed in the text simply by asserting
that its preferred approach would be better policy.’” Friends of the Earth, Inc. v. EPA, 446 F.3d
140, 145 (D.C. Cir. 2006), quoting Engine Mfrs. Ass’n v. EPA, 88 F.3d 1075, 1089 (D.C. Cir.
1996); see also Ethyl Corp. v. EPA, 51 F.3d 1053, 1060-61 (D.C. Cir. 1995) (rejecting
interpretation that added factors to a list of factors to be considered, even though there were
policy justifications for the additional factors, observing “Congress has neither explicitly or
implicitly delegated discretionary authority to the Agency to consider other factors ‘in the public
interest’….” Id. at 1060.).
2. No Deference for Statutory Interpretations Not Accompanied by Further
Explication
Creekstone has established that USDA’s interpretations of the VSTA are entitled to
little or no weight because they were announced with virtually no explanation of how they were
derived. Pl. Memo at 26-27, 30-31, 41. USDA does not deny this. Rather, its principal
response is to assert that one of the cases Creekstone cited, Adamo Wrecking Co. v. United
States, 434 U.S. 275, 287 (1978), was decided before Chevron and is therefore no longer good
law. USDA Memo at 34 n.16. Unfortunately for USDA’s argument, the principal for which
Creekstone cited Adamo Wrecking, that an agency’s statutory interpretation announced without
explanation or analysis is entitled to little weight, has been relied upon by the Supreme Court
and the D.C. Circuit many times since Chevron.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 28 of 52

- 23 -
For example, Public Citizen, Inc. v. U.S. Dept. of Health and Human Services, 332 F.3d
654, 662 (D.C. Cir. 2003) discusses the inapplicability of Chevron deference to situations where
the agency has not provided any explanation for its interpretation. “Because the manual thus
contains no reasoning that we can evaluate for its reasonableness, the high level of deference
contemplated in Chevron’s second step is simply inapplicable.” Id., citing Adamo Wrecking, as
well as SEC v. Sloan, 436 U.S. 103, 118 (1978) (reaching the same conclusion “where this Court
can only speculate as to the Commission’s reasons for reaching the conclusion that it did”
because the agency’s orders did not “address[ ] in any detail the statutory authorization under
which it took [the] action”).17
Barnett v. Weinberger, 818 F.2d 953, 960-64 (D.C. Cir. 1987), another post-Chevron
decision, declined to accord Chevron-like deference to the Department of Defense’s
interpretation of a statute under circumstances quite similar to the instant case:
In sum, the regulations in question were issued after what appears to
have been cursory consideration, were accompanied by neither explanation nor
justification, and were given a breadth that does not comport with the purposes
animating the statute purportedly interpreted. These elements buttress our
conclusion that the regulations are not entitled to significant weight in
delineating the scope of the statute’s “custodial care” provision.
Id. at 963 (footnote omitted). The Court considered it important that the Department offered no
explanation or discussion of the regulations providing the interpretation at the time they were
issued, “nor was any attempt made to support the regulations by an analysis of the legislative
history underlying the statute.” Id., citing Adamo Wrecking, 434 U.S. at 237 n.5, SEC v. Sloan,
436 U.S. at 117-18, and Investment Co. Inst. v. Camp, 401 U.S. 617, 627 (1971) (declining to
17 See also Federal National Mortgage Ass’n v. United States, 56 Fed. Cl. 228, 236-37 (Ct. of
Claims 2003) (noting that United States v. Mead, 533 U.S. 218 at 228 (2001), held no Chevron
deference is due to an IRS interpretation for which “no reasoning is given” (citing Adamo
Wrecking)).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 29 of 52

- 24 -
defer to an agency “in significant part because agency failed to buttress its interpretation with an
opinion or other supportive statement,” 818 F.2d at 963).
The interpretations of the VSTA USDA relies on to prevent Creekstone from testing its
cattle for BSE were all announced by USDA with virtually no explanation of why they
represent permissible and reasonable interpretations of the targeted language of the VSTA.18
See Pl. Memo at 26-27, 30-31, 41. USDA’s argument now that it has explained the basis for
those interpretations in subsequent Federal Register notices related to other provisions of its
VSTA regulations would make no sense even if those explanations were adequate. See USDA
Memo at 39 (apparently claiming that recent developments in genetic engineering technology
and other “advances in scientific knowledge” somehow justified USDA deciding 60 years after
the passage of VSTA that it should regulate the use of biological products to promote public
health and welfare and that diagnostic tests are analogous to vaccines and serums). But aside
from the fact that these would be post facto rationalizations in any event, the passages USDA
cited do not even state, much less purport to explain, that scientific advances justify expanding
USDA’s regulations under the VSTA to address use of biological products and regulation of
diagnostic products. If general scientific advancement were sufficient to justify an agency
regulating outside the terms of a statute, the words and choices of Congress could be rendered
meaningless with each new discovery or invention.
18 In its opposition to Creekstone’s Motion for Summary Judgment, USDA relies on opinions
interpreting comprehensive, far-reaching statutes, like the securities and labor laws, in which
Congress delegated to administrative agencies broad authority to regulate a whole sector of the
economy or aspect of commerce. USDA Memo at 27, 33. Such statutes necessarily imply
broader authority for the agency and greater leeway to adopt implementing regulations than a
statute like the VSTA, enacted to address specific concerns about particular types of products in
particular uses.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 30 of 52

- 25 -
Moreover, USDA’s interpretation of the VSTA’s provisions for permitting the
importation of biological products, 21 U.S.C. §§ 152-153, as additionally authorizing
regulation of the use of those products once they have been imported, is not even contained in
the USDA regulations implementing those provisions, much less supported by any
explanation.19 See Pl. Memo at 19-20. For that reason, it is entitled to little or no deference
under Christensen v. Harris Cty., 529 U.S. 576 (2000).
In fact, the only explanation that we have for USDA’s interpretations of its authority
under the VSTA to regulate the use of diagnostic products like BSE test kits is that provided by
USDA’s counsel in this litigation. Pursuant to well-established precedent, this Court should
reject such post hoc rationalizations of counsel. See, e.g., Bowen v. Georgetown Univ.
Hospital, 488 U.S. 204, 212-13 (1988); PanAmSat Corp. v. F.C.C., 198 F.3d 890, 897 (D.C.
Cir. 1999). This Court also should not accord any deference to USDA’s interpretations of its
19 USDA asserts that Creekstone is barred from requesting that the Court strike down 9 C.F.R. §
104.1—which on its face says nothing of restricting the manner in which an imported biological
product can be used, or by whom, or for what purpose—if, contrary to Creekstone’s position, the
Court finds that that particular regulation does authorize such restrictions, because Creekstone did
not include a demand in its complaint that 9 C.F.R. § 104.1 be overturned. See USDA Memo at
30; cf. Pl. Memo at 19-20. Creekstone’s Complaint did, however, state that “If USDA’s
regulations implementing the VSTA, at 9 C.F.R. Chapter I Subchapter E are broad enough to
cover the BSE test kits as described above, then those regulations are beyond the scope of the
rulemaking authority granted to USDA in the VSTA.” Complaint Count 1 ¶ 31. The USDA
regulation on import permits, 9 C.F.R. § 104.1, is contained in 9 C.F.R. Chapter I Subchapter E.
The prayer for relief in the Complaint also asks the Court to “Enter judgment declaring that
USDA lacks authority to restrict the use of BSE rapid test kits or to issue licenses for the
production of such test kits that limit to whom they may be distributed or how they may be used”
and to enjoin USDA “from implementing or enforcing any prohibition on Creekstone acquiring
or using USDA-approved BSE rapid test kits for purposes of routinely screening for BSE cattle
that Creekstone processes (including any restriction on the sale of such test kits to Creekstone).”
Creekstone does not believe that 9 C.F.R. § 104.1 authorizes restrictions on the use of imported
diagnostic tests like the Bio-Rad BSE test kits, and so it does not need to be vacated, but if the
Court concludes that it does give that authority to USDA, then Creekstone submits that the
provisions of the Complaint noted here provide a sufficient request for relief to allow the Court to
hold the regulation ultra vires and vacate it in this summary judgment proceeding.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 31 of 52

- 26 -
authority under the VSTA, consistent with Adamo Wrecking and subsequent cases, and should
conduct its own analysis of the breadth of the VSTA provisions, using the traditional tools of
statutory construction described above and in Creekstone’s Memorandum in Support.
3. Little Deference for Statutory Interpretations that Were Far from
Contemporaneous or Consistent
As Creekstone established, agency interpretations that are not contemporaneous with a
statutes’s enactment and that do not reflect long-held positions of the agency generally are
entitled to less deference than more contemporaneous interpretations. See Pl. Memo at 30.
USDA’s primary response is to claim—again without any citation—that this principle of
statutory interpretation no longer applies after the Supreme Court’s Chevron decision. See
USDA Memo at 38-39. In fact, this principle has been applied repeatedly and consistently
post-Chevron: “It is well established that the prestige of a statutory construction by an agency
depends crucially upon whether it was promulgated contemporaneously with enactment of the
statute and has been adhered to consistently over time.” Barnett v. Weinberger, 818 F.2d at
961-62 (footnote omitted) (giving little weight to an interpretation first announced 11 years
after enactment of statute). See also Continental Airlines, Inc. v. U.S. Department of
Transportation , 856 F.2d 209, 216-217 (D.C. Cir. 1988) (relying on an agency’s 1979
contemporaneous interpretation of applicable statute rather than a more recent one); Lynn
Martin v. Occupational Safety and Health Review Commission, 499 U.S. 144 (1991) (stating
that the consistency of application of interpretations bears on the reasonableness of the
agency’s position under Chevron); Railway Labor Executives, 29 F.3d at 669-70 (finding it
“telling” that the Board had not asserted its claim that it had latent authority under the statute to
allow carriers or the Board itself to initiate investigations for the first 50-plus years of the
statute’s 60-year history).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 32 of 52

- 27 -
USDA has given virtually no explanation for why the Department failed, for the first
two-thirds of the life of the VSTA, to recognize that it had the authority it now claims:
authority to regulate who may use biological products and for what purpose and to regulate
diagnostic tests as well as biological products themselves. In fact, so far as Creekstone has
been able to determine, the instant case is the first time ever that USDA has exercised this
purported authority to prevent a company from performing tests on its own livestock (let alone
on the carcasses of animals it has already slaughtered). See also Exh. (10 Detwiler Decl.) ¶ 24.
C. The Reenactment Doctrine Does Not Save USDA’s Unsupported Interpretation of the
VSTA.
Finally, USDA claims that its interpretation of the VSTA as authorizing USDA to
restrict who may have access to biological products and for what purpose they may use them
has been blessed by Congress and must be deferred to under the “reenactment” doctrine.20
USDA Memo at 28 n.14. Under that doctrine, courts “have frequently considered whether
reenactment of a statute after promulgation of an agency interpretation that is highly publicized
or otherwise communicated to Congress may be regarded as ratification by acquiescence.”
Barnett v. Weinberger, 818 F.2d at 963 n.89. But the VSTA was not reenacted when it was
amended in 1985; rather, Congress simply expanded a few of the provisions of the VSTA,
primarily to eliminate a dichotomy that had existed between regulation of biological products
shipped across state lines and those manufactured and used within the same state. See P.L. 99-
198, 99 Stat. 1654-56; S. Rep. No. 99-145, Sept. 30, 1985, at 338-39, reprinted in 1985
20 USDA seems to make that claim only with respect to its asserted authority over the use of
biological products, and not its claim that diagnostic tests are “analogous products” subject to
regulation under the VSTA. See USDA Memo at 28 n.14. Presumably that is because the
expansion of the definition of “analogous product” in 9 C.F.R. § 101.2 to include substances
“which are intended for use in the treatment of animals through the detection or measurement of
antigens, antibodies, nucleic acids, or immunity” did not occur until 1997. See 62 Fed. Reg.
31,326 (June 9, 1997).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 33 of 52

- 28 -
U.S.C.C.A.N. 2004-2005; Garrelts v. Smithkline Beecham Corp., 943 F. Supp. 1023, 1065-66
(N. D. Ia. 1996) (legislative history of 1985 amendments indicates narrow purpose of
amendments); see also Pl. Memo at 22-23; cf. Babbitt v. Sweet Home, 515 U.S. at 729 (Scalia,
J., dissenting) (subsequently enacted provision authorizing permits for “incidental take” of
endangered species does not implicate reenactment doctrine for agency interpretation of the
prohibition on “take” of endangered species).
Moreover, for the reenactment doctrine to apply, Congress must have been made aware
of the agency interpretation at issue. See, e.g., Barnett v. Weinberger, 818 F.2d at 963 n.89. In
particular, “application of the legislative reenactment doctrine requires a showing of both
Congressional awareness and ‘express congressional approval of an administrative
interpretation if it is to be viewed as statutorily mandated.’” General American Transp. Corp.
v. ICC, 872 F.2d 1048, 1053 (DC Circuit 1989) (quoting AFL-CIO v. Brock, 835 F.2d 912, 915
(D.C. Cir. 1987)); accord, International Union, UAW v. Brock, 816 F.2d 761, 767 (D.C. Cir.
1987) (finding no “affirmative step taken by Congress that indicates an intent to ratify the
agency’s interpretation” (emphasis in original)); accord, Koszola v. F.D.I.C., 393 F.3d 1294
(D.C. Cir. 2005); see also Pacific Power & Light Co. v. FPC, 184 F.2d 272, 275 (D.C. Cir.
1950) (“before a mere reenactment can be given conclusive effect as a congressional adoption
of an administrative interpretation, it must be shown that Congress was conscious that it was
doing so.”); 2B Sutherland Stat. Constr. § 49.09 (reenactment doctrine “does not apply when
nothing indicates that the legislature had its attention directed to the administrative
interpretation upon reenactment.”).21 USDA offers no evidence to this effect. And in fact, the
21 Cf. Lorillard v. Pons, 434 U.S. 575, 581–85 (1978), the case relied on by USDA (detailing
Congress’s familiarity with the statute and judicial interpretations of it and describing indications
of Congress’s intention to incorporate a contemporaneous construction of the statute).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 34 of 52

- 29 -
regulation that USDA claims authorizes restrictions on the use of an imported biological
product, and which was promulgated prior to the amendment of the VSTA in 1985, does not
make any mention at all of such restrictions. Cf. 9 C.F.R. § 104.1; see also Pl. Memo at 34
n.11 (no mention of regulating diagnostic tests in legislative history of 1985 VSTA
amendments).
USDA also implies that its interpretation of the VSTA as authorizing prohibitions on
private BSE testing must be deferred to because of a vote by the House Appropriations
Committee not to adopt a rider to an appropriations bill that would have required USDA to
allow Creekstone and others to conduct private BSE testing. USDA Memo at 10. But even a
negative vote by Congress on a bill is “a particularly dangerous ground on which to rest an
interpretation of a prior statute.” Solid Waste Agency of Northern Cook County v. U.S. Army
Corps of Engineers, 531 U.S. 159, 169-70 (2001). Accord, Central Bank of Denver, N.A. v.
First Interstate Bank of Denver, N.A., 511 U.S. 164, 187 (1994); Brown & Williamson, 529
U.S. at 155. A failed committee vote on an appropriations rider lacks any legal significance.22
III. USDA LACKS STATUTORY AUTHORITY TO REGULATE BSE TEST KITS IN
PARTICULAR.
To be subject to USDA’s regulatory authority under the VSTA, something must be
both a “virus, serum, toxin, or analogous product” and “used in the treatment of domestic
animals.” 21 U.S.C. §§ 151, 152, 154. And for USDA to “prevent the preparation, sale, barter,
22 In contrast, USDA offers no response to Creekstone’s demonstration, from the text and
legislative history of the Agricultural Bioterrorism Protection Act of 2002, sections 211-213 of
the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, P.L. 107-
188, 116 Stat. 647, that Congress did not believe USDA’s regulatory authority extended to who
may use biological products. See Pl. Memo at 24-25; see also Brown & Williamson, 529 U.S. at
133 (“the meaning of one statute may be affected by other Acts, particularly where Congress has
spoken subsequently and more specifically to the topic at hand.”) (citations omitted).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 35 of 52

- 30 -
exchange, or shipment” of such a product, it must be “worthless, contaminated, dangerous, or
harmful.” Id. at § 154. As Creekstone showed in its Pl. Memo at 34-40, test kits used for BSE
screening of apparently healthy cattle at slaughter do not meet any of those criteria.23
A. BSE Test Kits Are Not “Analogous Products.”
The commonsense meaning of “virus, serum, toxin, or analogous product” is that
analogous products are other products that, similar to the viruses, serums, and toxins mentioned
specifically in the VSTA, are given to animals to supplement the animal’s antibodies or to cause
the animal’s immune system to generate more of its own antibodies, to prevent or mitigate the
effects of disease. USDA itself has expressed that understanding of what “analogous product”
means. See Pl. Memo at 29, 38 n.14. Creekstone has demonstrated that this interpretation of
“analogous products” is also consistent with the legislative history of the VSTA, is reflected in
USDA’s own regulations contemporaneous with and extending for decades after enactment of the
VSTA, and is similar to the way courts have interpreted virtually identical language to “virus,
therapeutic serum, toxin, antitoxin, or analogous product” in the human version of the VSTA, the
23 USDA attempts to narrow the scope of this argument by distinguishing between “whether
USDA’s authority to regulate diagnostic tests extends as a general matter to BSE test kits” and
“whether USDA was required to make an exception to license restrictions prohibiting the sale of
BSE test kits for purposes other than government surveillance testing, in order to permit plaintiff
to conduct private testing for its own marketing purposes.” USDA claims that the latter is the
subject of Count 3 of the Complaint and therefore not covered by the current process and motions
for summary judgment. USDA memo at 40 n.21. To the contrary, the issue Creekstone has
raised is whether the VSTA authorizes USDA to prohibit the sale of BSE test kits for uses other
than government surveillance testing. That is a question of whether USDA’s license restrictions
and other actions regarding by whom BSE test kits may be used and for what purposes are “in
excess of statutory jurisdiction, authority, or limitations, or short of statutory right,” in violation
of 5 U.S.C. § 706(2)(C)—the subject of Counts 1 and 2 of the Complaint.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 36 of 52

- 31 -
Act of July 1, 1902, ch. 1378, 32 Stat. 728, on which the VSTA was modeled. Pl. Memo at 23-
25, 27-30.24
Even if USDA is correct that “[d]iagnostic test kits frequently rely on the interaction of
antibodies and antigens to stimulate, modulate, or detect the immune system of an animal, as do
products made with viruses, serums, or toxins” (USDA Memo at 36), that would not mean that
such test kits are “analogous products” to vaccines and similar products used to prevent or cure
diseases. See pp. 19-21, supra. But in any event, as Creekstone has shown, USDA itself has
recognized that certain products made from microorganisms may be “analogous products” in
some settings and products unregulated by the VSTA in others. Pl. Memo at 36-38. So even if
diagnostic test kits “frequently” involve the stimulation or modulation of the immune system of
an animal, as USDA maintains, that does not suggest that all diagnostic test kits, including BSE
test kits, must be “analogous products” subject to USDA’s regulatory authority under the VSTA.
For example, EPA provided this description of substances that may or may not be
“analogous products,” depending on how they are used:
It is now recognized in the scientific literature that the generation or stimulation
of an immune response involves both antigens and certain protein regulatory
factors referred to as cytokines. Some cytokines (e.g. interleukins) serve as an
essential components in the generation and expression of an immune response,
without which the vaccine would be worthless…. Cytokines are also produced in
many body tissues and act on cell types other than those of the immune system.
Cytokines of natural or synthetic origin can be prepared as products for
administration to animals. Because of the diverse biological activity of the
cytokines, not all products consisting of these substances would be regulated
under the VSTA. Many of these cytokines intended to be used as drugs would fall
under the jurisdiction of the Food and Drug Administration. In such instances,
the VSTA would not apply.
24 USDA tries to dismiss the cases cited by Creekstone as irrelevant because they were not
interpreting the VSTA. USDA Memo at 36 n.18. But, as Creekstone indicated, the language of
the human version of the VSTA is almost identical, and courts have held that they should be
interpreted similarly. See p. 13, supra; Pl. Memo at 30 n.10
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 37 of 52

- 32 -
Both cytokines and immunomodulators are analogous to biological products
when they are used to stimulate, supplement, enhance, or modulate the immunity
of animals in the treatment of disease. Products consisting of these substances
that work through the immune mechanisms in the treatment of specific disease
appropriately fall within the definition of “biological products.”
62 Fed. Reg. 31,326, 31,327 (June 9, 1997) (emphasis added.) BSE test kits, which are used to
determine whether an animal carcass is infected with a disease that does not even involve the
animal’s immune system, are not a product that works through the immune system to treat a
specific disease, and therefore should not be considered an “analogous product” under this USDA
rulemaking precedent.
USDA’s declarant, Dr.Rippke (whose declaration provides no information about his
training and qualifications other than that he has worked at USDA for 20 years and in the
implementation of the VSTA—which addresses hundreds of products besides the few related to
BSE—for the last 10 years), provides only the barest of analysis to support his conclusion that
BSE test kits are analogous to viruses, serums, and toxins. Cf. USDA Memo Exh. 2 ¶¶ 7-8. In
contrast, in Exhibit 8 to this Reply, Paul W. Brown, M.D., a real expert in neurology and in
transmissible spongiform encephalopathies in particular, explains that “BSE tests do not involve
the immune system of the animal that is tested. There is a sharp distinction between using
immunological means to prevent foreign pathogen infections (e.g., active and passive
immunization) and the use of an immunologic reagent (e.g., an antibody) to detect infectious
prion proteins obtained from the body of an infected host. The use of such a test has nothing
whatsoever to do with the immune system of the infected (and now dead) animal.” Id. ¶ 16. In
fact, USDA has already acknowledged that BSE itself does not even work through the immune
system of the cattle it afflicts: “The BSE agent does not evoke any demonstrated immune
response or inflammatory reaction in host animals.” 70 Fed. Reg. 460, 461 (Jan. 4, 2005). As
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 38 of 52

- 33 -
Dr. Brown says, “USDA thinking on this point is very confused.” Exh. 8 ¶ 16. Dr. Rippke’s
conclusory statements notwithstanding, there is nothing about BSE test kits, which do not involve
the immune system of cattle and in fact can only be administered to dead cattle, that makes them
analogous to vaccines and therapeutic serums administered to animals to prevent or cure
disease.25
B. BSE Test Kits Are Not, and Would Not Be, Used in the Treatment of Animal
Disease.
USDA sets out a circular argument: BSE test kits are “intended for use in the treatment of
domestic animals,” even though there is no treatment for BSE and USDA claims that routine
testing of normal-appearing cattle at slaughter has no BSE mitigation benefit. USDA Memo at
40-44. USDA then claims authority to prevent access to BSE test kits for routine testing because,
it alleges, they are worthless for the treatment of domestic animals in that use. The Court should
reject this attempt to “have it both ways.”
USDA’s claim that a test which is used to determine whether meat from a slaughtered
animal might be infected is “intended for use in the treatment of domestic animals” is
nonsensical, especially given that there is no known treatment for the infection and the test can
25 USDA also relies on its regulation (which, as Creekstone has already shown, is inconsistent
with the VSTA in any case, Pl. Memo at 29-31), 9 C.F.R. § 101.2(2)(ii), which defines
“analogous products” to include substances that do not even act on the immune system but rather
are used for “the detection or measurement of antigens, antibodies, nucleic acids, or immunity.”
USDA asserts that BSE test kits fall under that definition and are therefore analogous products in
any event because they are tests for “antigens.” USDA Memo at 41 n.22. But USDA’s reference
for that contention, ¶¶ 7-8 of the Rippke declaration, refers to BSE test kits as acting “through the
immunological detection of specific antigens found in animal tissue indicative of disease,” even
though it also states that “antigens” are materials “that, as a result of coming in contact with
appropriate tissues of an animal body, stimulate an immune response.” Id. ¶ 7. See also Grand
Laboratories, Inc. v. Harris, 488 F. Supp. 618, 619 (D.S.D. 1980), rev’d on other grounds, 660
F.2d 1288 (8th Cir. 1981) (referring to “antigen” as “the biological component intended to
produce an immune response”). Given that BSE does not involve an immune response in cattle
(see text supra), Dr. Rippke’s description of BSE test kits as identifying “antigens,” meaning the
prion proteins believed to cause BSE, is internally inconsistent and should be disregarded.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 39 of 52

- 34 -
only be used on cattle that are already dead. See USDA Memo at 41-42. USDA relies in part on
its regulations that the determination of whether a product is intended for the use in the treatment
of domestic animals is to be based on objective criteria indicating the intent of the manufacturer.
9 C.F.R. § 101.2(1); see USDA Memo at 43 n.24. Here, BSE test kit manufacturers, such as Bio-
Rad, market millions of BSE test kits a year to countries that conduct BSE tests on the carcasses
of all animals presented for slaughter (mandatory above a certain age in EU countries). Given
USDA’s assertion that BSE test kits are ineffective for BSE disease mitigation purposes unless
applied to targeted cattle with symptoms that might be indicative of BSE, the marketing of BSE
test kits for other purposes provides an incontrovertible objective indication that BSE test kits, as
the manufacturer intends them to be used and as intended to be used by Creekstone, are not
“intended for use in the treatment of domestic animals,” despite USDA’s assertion to the
contrary. Cf. id. Thus, USDA’s actions dictating that BSE test kit manufacturers and importers
cannot sell the test kits for purposes other than treating BSE in cattle are ultra vires.
C. BSE Test Kits Are Not Worthless, Contaminated, Dangerous or Harmful.
Having asserted authority to regulate the use of BSE test kits by Creekstone and other
meat producers because BSE test kits are intended for use in the diagnosis of BSE in cattle,
USDA turns around and claims (for the first time in writing, cf. Pl. Memo Exh. 1 Attachments
5, 7, and 10) that BSE test kits are “ineffective…and essentially worthless as an animal health
measure when used, as proposed by plaintiff, to diagnose the disease in all slaughter-aged
normally-looking cattle.” USDA Memo at 42. Since Creekstone never claimed that its planned
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 40 of 52

- 35 -
BSE testing would be valuable as an animal human health measure and never proposed to use it
to diagnose BSE for the purpose of treating animals, this is really a “straw man” argument.26
In any case, USDA’s claim that the VSTA authorizes it to ban private use of BSE test kits
because they are worthless when applied to brain tissue from “slaughter-aged normally-looking
cattle” is contradicted by a wide array of facts and indeed even USDA’s own assertions. The
countries of the European Union performed BSE tests on almost 9 million cattle that were
healthy-appearing at slaughter in 2005 alone. Report on the Monitoring and Testing of
Ruminants for the Presence of Transmissible Spongiform Encephalopathy (TSE) in the EU in
2005, European Commission, 20 June 2006, p. 12 Table B1, available at
http://ec.europa.eu/food/food/biosafety/bse/annual_reps_en.htm (attached as Exhibit 9). A
significant portion of the BSE cases found in the EU in 2005 (114 of 491 cases) were in healthylooking
cattle tested at slaughter. Id. at p. 18 Chart B3. France, Germany, and Italy currently test
all cattle over 24 months of age, and Germany allows voluntary testing of cattle 24 months and
younger. Id. at p. 8 Table 2. Japan currently tests cattle of all ages at slaughter, and Japanese
officials consider BSE testing a measure for “ensuring the safety of meat.” Pl. Memo at 9-10 and
Exh. 5 at 2-3. While most cattle slaughtered in the U.S. are under 30 months of age, BSE has
been detected in cattle younger than that, although infrequently. Declaration of Linda A.
Detwiler, D.V.M. (Exh. 10) ¶ 22; Ferguson Decl. (USDA Memo Exh. 1) at ¶ 5; Pl. Memo Ex. 5
at 2 (BSE in 21 and 23 month old cattle in Japan). In addition, the usual method of estimating the
age of cattle, dentition, is inherently inaccurate. Exh. 8 (Brown Decl.) ¶ 11.
26 USDA does not contend that BSE test kits are “contaminated, dangerous, or harmful,” 21
U.S.C. § 151. USDA’s claim that BSE test kits as proposed to be used by Creekstone are
“misleading” (USDA Memo at 42) does not relate directly to any criterion for regulation under
the VSTA. In any event, USDA does not suggest that BSE test kits are ineffective at determining
whether concentrations of BSE prions above the detection limit of the test are found in the tested
tissue. Thus there is nothing inherent about the test itself that is misleading.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 41 of 52

- 36 -
Under these facts, USDA cannot simply declare that BSE test kits are worthless when
used on healthy-looking cattle under 30 (or 24) months of age (which USDA refers to as
“slaughter-age”). USDA’s arguments do not hold up to even cursory examination. USDA
asserts that BSE test kits applied to healthy-appearing cattle at normal slaughter age could “miss”
BSE-infected cattle—but only because the BSE infection in the animal has not progressed far
enough for the BSE tests to detect it. USDA Memo at 43. But if no BSE testing is performed on
slaughter-aged, healthy-appearing cattle, then 100% of those infected cattle will enter the food
chain. Catching even a few such cases of this fatal, incurable disease would obviously be of great
value. Exh. 8 (Brown ) ¶ 11; Exh. 10 (Detwiler) ¶ 21. In fact, neither of USDA’s declarants say
that BSE testing would be worthless; the closest they come is to say that USDA’s targeted testing
“is the most efficient method” of monitoring for BSE. USDA Memo Exh. 1 ¶ 6.27
USDA asserts that BSE can only be detected ‘two to three months before a cow would
demonstrate clinical signs of the disease.” USDA Memo at 43. Even that would be valuable, of
27 USDA describes its targeted testing of a fraction of the cattle most likely to test positive for
BSE as testing “to accurately diagnose the presence or absence of the disease” (USDA Memo at
49), and a negative inference could be made from Dr. Ferguson’s declaration that USDA’s
targeted testing can “be interpreted to mean that the animal is necessarily ‘BSE-free’” (Ferguson
Decl. ¶ 6). But in fact, the testing USDA is conducting, just like the testing Creekstone proposes
for its cattle, will only diagnose the presence of BSE if the disease has progressed quite far. See
Ferguson Decl. at ¶ 6 (“there is a long period in the life of an infected animal when current tests
would not detect the disease”). Thus, even USDA’s “targeted” testing can result in “false
negative” test results, if infected animals that are non-ambulatory or suspect for other reasons are
BSE-tested at a time when infectious prions are not concentrated enough in their brain stem to be
identified in available tests. Only if cattle fall into one of the groups which USDA is testing
(because, e.g., they are having trouble walking, or have died of unknown causes) and they have
BSE which has spread to the point where the animal will die of BSE within a few months will the
testing USDA is conducting identify BSE-infected cattle. USDA’s emphasis on “false negative”
results in tests that Creekstone proposes to perform, when USDA’s own testing also could result
in false negative results, is additional confirmation that USDA’s claim that BSE tests are
“worthless” is just that—an assertion unsupported by the facts.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 42 of 52

- 37 -
course, but it seriously understates the value of BSE testing.28 USDA simply chooses to ignore
information that demonstrates the inaccuracy of its “2-3 months” argument. For example, on
August 24, 2006 the Canadian Food Inspection Agency (CFIA) issued a report on a 50-month-old
cow from Alberta, Canada that was confirmed to be BSE-infected on July 13, 2006. See
(Detwiler Decl.) Attach. B. The conclusion of the CFIA (which has dealt with four times as
many BSE cases as USDA), was that “in this instance, had the cow not succumbed to an
unrelated disease and had a brain stem sample submitted for BSE testing, it would probably have
been four to eight months longer before the cow would have displayed symptoms that might have
caused it to be tested because of suspicion of BSE.” Exh. 8 (Brown Decl.) ¶ 5.
Moreover, it is undisputed that, when countries have gone from testing only cattle with
outward signs that might indicate BSE to testing all cattle above a certain age, they have detected
many more cases of BSE. Analysis of the experience in France as it went from “passive” testing
only of suspect animals, to testing of all cattle over 30 months of age, to testing all cattle over 24
months, shows that passive surveillance was picking up only a fraction of the cases of BSE
infection that were detectable with BSE rapid tests. Supervie and Castagliola, “The
Unrecognized French BSE Epidemic,” 35 Vet. Res. 349, 351-52, 358, 361 (2004) (attached as
Exhibit 11). This may be in part because the clinical signs of BSE are “very subtle.” See USDA
Memo Exh. 26 at Article 3.8.4.2 ¶ 1. In fact, both of the indigenous cases of BSE discovered in
the U.S. were in cattle with ambiguous or no clinical features. Exh. 8 Attach. C at 1817.
28 The OIE Terrestrial Animal Health Code – 2005, Appendix 3.8.4, Surveillance for Bovine
Spongiform Encephalopathy, on which USDA relies in part (USDA Memo Exh. 26), recognizes
that cattle where BSE is detectable but clinical signs have yet to appear is a larger group than
those showing clinical signs. Id. at Article 3.8.4.1 ¶ 2.c.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 43 of 52

- 38 -
USDA also ignores the growing data about “atypical” BSE infection, which usually is
not accompanied by any outward signs even at an advanced state of infection. See Exh. 8 ¶ 8
and Attach. C. “Thus, some cattle that on visual inspection appear normal are infected, and this
fact negates any argument about a limited window of ‘pre-clinical’ positivity in BSE tests, as
there are no signs leading to a suspicion of infection. The only way that these cattle are
identified as BSE-infected is through testing.” Exh. 8 (Brown Decl.) ¶ 8 (citation omitted). Far
from making BSE testing of asymptomatic cattle worthless, it makes such testing essential for
an understanding of this aspect of the disease. Id. ¶ 14.
In short, “[p]reventing voluntary testing while at the same time dramatically reducing
government testing does not make any sense for the protection of animal and human health and
is further indication that voluntary BSE testing is not ‘worthless.’” Exh. 8 (Brown Decl.) ¶ 15.
USDA’s statutory authority under the VSTA to prevent the sale or shipment of biological
products extends only to those that are “worthless, contaminated, dangerous, or harmful.” 21
U.S.C. § 154. When USDA acts to prevent distribution of BSE test kits to all but USDA
contractors because USDA believes that it is not cost-effective to use USDA-approved test kits
on all healthy-looking, slaughter-age cattle (or because USDA believes the use of those test kits
will have economic consequences for beef producers or national and international consumer
confidence in beef, as discussed in the following section), USDA is not acting to ban a
“worthless” product, and therefore it is acting outside its statutory authority in violation of the
Administrative Procedure Act, 5 U.S.C. § 706(2)(C).
Much of the declaration of Lisa Ferguson (USDA Memo Exh. 1) seems to be aimed at
convincing the Court that BSE is a dwindling, not-very-serious problem. Although overstated,
that is in any case beside the point, since nothing about the VSTA would authorize USDA to
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 44 of 52

- 39 -
prevent the sale or shipment of a vaccine or a diagnostic test for a rare disease.29 If a vaccine
were developed to treat a rare but invariably fatal disease, which only 0.001% of the U.S. cattle
herd of 90 million head may contract, could USDA prohibit the manufacture and sale of that
vaccine because USDA decided the disease was not important enough to warrant ranchers’
purchasing the vaccine?
IV. USDA’S RESTRICTIONS ON BSE TEST KITS ON ECONOMIC GROUNDS ARE
OUTSIDE ITS AUTHORITY UNDER THE VSTA.
As Creekstone has explained, USDA acts outside of its statutory authority, in violation
of section 706(2)(C) of the Administrative Procedure Act when it prevents access to and use of
BSE test kits for reasons outside of the purposes and criteria expressed in the VSTA. Pl.
Memo at 41-43. In particular, since USDA is banning access to BSE test kits for purposes
unrelated to the purposes of the VSTA, such as promoting domestic and international
confidence in beef, controlling costs of meatpackers, and the like, USDA is acting outside its
statutory authority. Pl. Memo at 42, 44.30
USDA asserts that this issue goes to whether USDA acted in an arbitrary and capricious
manner (Count 3 of the Complaint), and not Counts 1 and 2, which are the subject of
Creekstone’s current Motion for Summary Judgment. But to the extent that USDA has
promulgated regulations that it now asserts authorize it to restrict the use of biological products
29 The declarations of Drs. Brown and Detwiler (Exhibits 8 and 10 to this Reply Memo) make it
very clear that (1) much of what Dr. Ferguson states as unqualified fact is actually more of an
educated guess and (2) BSE is far from eliminated and indeed recent developments (ignored by
Dr. Ferguson’s declaration) make voluntary BSE testing even more important. See also, e.g.,
Exh. 11 at 357 (referring to “animals slaughtered in the late stage of incubation when it is
hypothesized that infected tissues are infectious” (emphasis added); Exh. 8 Attach. C at 1820; Pl.
Memo Exh. 3 at 91 (Dr. Prusiner explaining why the feed ban will reduce but not eliminate BSE.)
30 Creekstone also noted that, if the reference in USDA regulations at 9 C.F.R. § 102.5(d) to “the
protection of domestic animals or the public health, interest, or safety, or both” could be read to
authorize restrictions on biological products for purposes unrelated to the efficacy or safety of
such products, then that regulation should be struck down as ultra vires, as well. Pl. Memo at 43.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 45 of 52

- 40 -
for reasons other than for animal health and has issued product licenses, advisories, and other
communications concerning BSE tests for purposes that have nothing to do with its regulatory
authority in the VSTA, USDA has acted “in excess of statutory jurisdiction, authority, or
limitations, or short of statutory right,” in violation of 5 U.S.C. § 706(2)(C)—the subject of
Counts 1 and 2 of the Complaint.31 (Of course, if the Court believes that this issue more
appropriately falls under Count 3 of the Complaint, then the Court could simply defer ruling on
this particular argument until it is briefed in connection with a summary judgment motion on
Count 3 (should Creekstone be denied summary judgment on both Counts 1 and 2).)
USDA’s substantive response is to assert (1) that its actions preventing private parties
from BSE testing further the purposes of the VSTA by protecting animal health and (2) that
regulating BSE test kits to achieve various economic or market ends is also authorized by the
“purpose” of the VSTA. Neither of these arguments makes sense.
USDA has said or implied numerous times that its policy of preventing BSE testing of
healthy-appearing cattle at slaughter (i.e., those least likely to have BSE) promotes animal
health. See, e.g., USDA Memo at 48. But USDA has never explained how that could be. Just
because BSE testing of healthy-appearing younger cattle is unlikely to identify a case of BSE
does not mean that such testing would be harmful to animal health. A “false negative” result
(which USDA in any case would expect to be extremely rare, since it estimates that there are
seven or fewer BSE-infected cattle in the U.S., Defendants’ Statement of Undisputed Material
Facts ¶ 5) could not be more “harmful” to animal health than not testing the animal at all.
31 In contrast, Creekstone would be presenting an argument covered by Count 3 of the Complaint
if it were arguing here that, even if USDA were authorized by the VSTA to regulate the use of
biological products for reasons other than to protect domestic animals (and, indirectly, their
owners) from ineffective or harmful biological products, it was arbitrary and capricious for
USDA to exercise that authority in order to protect Creekstone’s competitors from having to test
themselves or for other unreasonable reasons.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 46 of 52

- 41 -
USDA’s illogical pretext for banning private BSE testing is further exposed by the fact
that virtually every developed country with BSE tests 100% of cattle over 24 or 30 months of
age, and Japan tests all cattle presented for slaughter. See Section III.C., supra. The value of
large-scale testing is reinforced by the statements of internationally recognized experts on BSE
and the management of BSE and similar diseases, Dr. Paul Brown and Dr. Linda Detweiler
(Exhs. 8 and 10), that it is important to perform a greater amount of BSE testing in the United
States and that any data on the presence or absence of BSE in cattle slaughtered in the United
States is of value. Since Creekstone’s proposed voluntary testing would not prevent any
government testing for BSE, but would only provide supplemental data, there is simply no
reason to conclude that Creekstone’s proposed use of BSE test kits would adversely affect
animal health.32 USDA does not even attempt to explain its bald assertion that Creekstone’s
voluntary testing would interfere with USDA’s efforts “to accurately diagnose the presence or
absence of the disease” and, “through its surveillance testing, to manage the disease.” USDA
Memo at 49. Cf. Rippke Decl. (USDA Memo Exh. 2) (stating that current USDA BSE testing
“will contribute to the knowledge of the disease and may increase the chances of developing
therapies or potential cures for the disease in the future,” but omitting any mention of the effect
of voluntary BSE testing as proposed by Creekstone); Ferguson Decl. (USDA Memo Exh. 1)
(stating that USDA’s testing of targeted animals is “the most efficient method for detecting the
presence of BSE” (¶ 6), but never even claiming that Creekstone’s proposed testing would
interfere with USDA’s “surveillance testing” for BSE).
32 Perhaps an argument could be made to that effect if Creekstone’s testing would use up limited
laboratory capacity or test kit manufacturing capacity that otherwise could be used for higherpriority
BSE testing. But USDA has not made such an argument, and in fact Creekstone has
constructed its own laboratory for BSE testing and there is no shortage of BSE test kit
manufacturing capacity (especially now that USDA has reduced its BSE testing by 90%).
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 47 of 52

- 42 -
If there was any doubt before, it is clear after reading the USDA Memo that USDA’s
prohibition of the manufacture and sale of BSE test kits, except for use in USDA’s own BSE
testing program, is an action to further USDA’s views of what is good for domestic and foreign
markets for beef and for the financial health of U.S. meatpackers, rather than to prevent the
manufacture and sale of a worthless or harmful biological product as the VSTA directs. It
therefore is an action “in excess of statutory jurisdiction, authority, or limitations, or short of
statutory right.” 5 U.S.C. § 706(2)(C). USDA openly acknowledges that it was acting for
purposes of “maintaining domestic and international confidence in U.S. cattle and beef
products,” “protecting consumers from paying more for privately BSE tested beef,” and
“correcting market deficiencies and information asymmetries pertaining to the effectiveness of
BSE test kits.” USDA Memo at 51-52. Tellingly, for the first time USDA admits its
motivation that prohibiting private BSE testing “also prevents beef producers from having to
incur increased costs of conducting the BSE testing, which, although useless for animal health
and food safety purposes, might otherwise be necessary to remain competitive if private BSE
testing were permitted.” Id. at 52 n.30.
USDA’s defense of its actions is to claim that, although not directly authorized by any of
the provisions of the VSTA, they are “consistent with VSTA’s purpose.” USDA Memo at 52.
Creekstone does not dispute that Congress enacted the VSTA in part to protect the economic
interests of livestock owners from biological products that would harm their livestock or would
be worthless. But a regulatory action is not authorized by a statute just because it is consistent
with the statute’s purposes. A specific grant of authority from Congress is necessary. Rodriguez
v. United States, 480 U.S. 522, 526 (1987); American Fin. Servs. Ass’n v. FTC, 767 F.2d 957,
965), cert. denied, 475 U.S. 1011 (1986)); Railway Labor Executives’ Ass’n, 988 F.2d at 141 n.10
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 48 of 52

- 43 -
(“However sensible the Board’s view that stability in labor relations would be promoted by [the
challenged regulation] …, Congress has not so provided.”) If USDA’s position were the law,
then USDA could also, for example, dictate to biological products manufacturers the maximum
amount they could charge for each product, because keeping prices low would benefit the
economic interests of livestock owners and beef producers. See also 62 Cases of Jam v. United
States, 340 U.S. 593, 600 (1951) (“In our anxiety to effectuate the congressional purpose of
protecting the public, we must take care not to extend the scope of the statute beyond the point
where Congress indicated it would stop.”)
A biological product is not “worthless, contaminated, dangerous, or harmful” for “use
in the treatment of domestic animals,” 21 U.S.C. § 151, because USDA thinks that its use
would put others at a competitive disadvantage or would interfere with “maintaining domestic
and international confidence in U.S. cattle and beef products.”33 This Court should be
particularly cautious about inferring in the VSTA authority to restrict access to biological
products for purposes of preventing competition among meat producers—even competition on
grounds that USDA believes would be inappropriate—or consumer access to information.
Other government agencies are charged with regulating competition and fraudulent
representations to consumers. Imposing such limitations on speech carries with it important
Constitutional constraints. And action by USDA—or indeed any government agency—
specifically designed to favor one set of competitors (large meatpackers with low margins) over
33 USDA Memo at 51-52. In any event, USDA provides no explanation for this contention,
which is counterintuitive, especially given that 100% testing (of all cattle, in Japan, and of cattle
over 24 months in France and Germany, and over 30 months in the remainder of the EU, see p.
35, supra) is already the norm in many of those international markets, and consumers in Asia
have been seeking testing for imported beef. This Court should not simply accept USDA’s
unsupported assertion that more testing for BSE would make consumers less confident in the
safety of U.S. beef. See also Exhibits 1-6.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 49 of 52

- 44 -
others (Creekstone and other high-end meatpackers with an interest in BSE testing) is not only
inappropriate as a matter of policy, it likely is unconstitutional. The Court should refrain from
interpreting the “VSTA’s purpose” as authorizing such potentially unconstitutional actions.
See Edward J. DeBartolo Corp. v. Florida Gulf Coast Building & Constr. Trades Council, 485
U. S. 568, 575 (1988) (courts should construe a statute to avoid constitutional problems “unless
such construction is plainly contrary to the intent of Congress”).
In any event, USDA’s argument is that its restriction of access to BSE test kits is
consistent with the VSTA’s purpose to protect farmers and ranchers from economic losses
associated with harmful or ineffective biological products. USDA Memo at 50-51. But even
this broad, vague claimed authority does not support USDA’s claim that actions to protect
consumers from paying more for BSE-tested beef (USDA Memo at 52) are consistent with the
VSTA’s purpose “to protect the economic interests of livestock owners and beef producers”
(id.), since actions to protect consumers of meat do not relate to the financial well-being of
farmers and ranchers per se at all. (Instead, USDA now makes the remarkable claim that the
VSTA authorizes it to “regulate the economic condition of [the beef] market.” Id.) Even if
authorization to ban private use of BSE test kits could be derived solely from the purposes of
the VSTA, none of those purposes supports USDA actions ostensibly directed at providing
accurate information to beef consumers or protecting beef producers from competition.34
34 Contrary to USDA’s assertion (USDA Memo at 51 n.27), Garrelts v. Smithkline Beecham
Corp., 943 F. Supp. 1023 (N. D. Ia. 1996), is very relevant to this case. After an extensive
analysis of the 1913 enactment of the VSTA and its amendment in 1985, the Garrelts court
concluded that in both instances “Congress’s concern was regulation of the worthlessness,
contamination, dangerousness, or harmfulness of animal vaccines to livestock, not the general
duties of product manufacturers…to safeguard human users of their products….” Id. at 1068
(emphasis in original); see also id. at 1066-67. Obviously, the economic interests of beef
processors and consumers are even further removed from that congressional purpose.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 50 of 52

- 45 -
V. USDA IS NOT ENTITLED TO SUMMARY JUDGMENT.
USDA has offered almost no argument directed specifically to its cross-motion for
summary judgment, apparently believing that, if its arguments against Creekstone’s summary
judgment motion are successful, then USDA will be entitled to summary judgment itself. That
is, of course, not the way the law works.
First, as USDA has noted, by agreement Creekstone has only moved for summary
judgment on Counts 1 and 2 of its Complaint, leaving Count 3 for a fuller development of the
record if the Court should conclude that Creekstone is not entitled to summary judgment on
either Count 1 or Count 2.35 See Pl. Memo at 1 n.1; USDA Memo at 13 n.7. Secondly, the
Court could decide that Creekstone has not qualified for summary judgment on Counts 1 and 2,
without finding that USDA has met its burden of demonstrating that there is no genuine issue
as to any material fact and that USDA is entitled to judgment as a matter of law on those counts
(which USDA certainly has not). See Fed. R. Civ. P. 56(c).
CONCLUSION
For the reasons explained above and in Creekstone’s Memorandum in Support of its
Motion for Summary Judgment, Creekstone is entitled to summary judgment on Counts 1 and
2 of its Complaint, and for the relief sought therein.
Dated: November 3, 2006 Respectfully submitted,
__/s/ Russell S. Frye _
Russell S. Frye (D.C. Bar No. 331124)
35 The only argument that USDA has even asserted that could apply to Count 3 of Creekstone’s
complaint is that the Court lacks jurisdiction to hear Creekstone’s claims because they are moot
or do not present a redressable injury. As Creekstone has demonstrated in Section I of this
memorandum, those arguments are misguided and unavailing.
Case 1:06-cv-00544-JR Document 14-1 Filed 11/03/2006 Page 51 of 52

- 46 -

END...TSS
 

flounder

Well-known member
Creekstone Farms Premium Beef v. USDA
Civ. Action No. 06-544 (JR)
Plaintiff’s Summary Judgment Reply and Opposition
EXHIBIT 8
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 1 of 47

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
__________________________________________________
)
CREEKSTONE FARMS PREMIUM BEEF, LLC, )
)
Plaintiff, )
)
vs. ) Civil Action No. 06-544 (JR)
)
UNITED STATES DEPARTMENT OF AGRICULTURE, )
and MIKE JOHANNS, IN HIS CAPACITY AS THE )
SECRETARY OF AGRICULTURE, )
)
Defendants. )
__________________________________________________)
DECLARATION OF PAUL W. BROWN, M.D.
Paul W. Brown, MD, certifies and states as follows:
1. My entire 43-year career has been devoted to the study of the Transmissible
Spongiform Encephalopathies (TSEs, or ‘prion diseases’) in the National Institutes of Health (NIH)
laboratory of Nobel Laureate D. Carleton Gajdusek; and for the last 15 years of my career I held the
position of Senior Investigator at the National Institute of Neurological Disorders and Stroke
(NINDS) at the NIH. In this capacity I oversaw and conducted research involving these invariably
fatal, neurodegenerative diseases, which include both bovine spongiform encephalopathy (BSE),
commonly referred to as “mad cow” disease, and variant Creutzfeldt-Jakob Disease (vCJD), a
human TSE infection acquired by the consumption of BSE-contaminated meat products.
2. Since leaving the NIH two years ago, I have continued to engage in research, writing,
and scientific advisory activities in various aspects of TSE. Ongoing research projects include an
ultra-high pressure methodology to inactivate the agent of BSE; a pre-clinical diagnostic blood
screening test for TSEs in general, and variant CJD in particular; and a study to determine whether
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 2 of 47

-2-
blood infectivity in humans with CJD can be diluted to extinction (important in the context of the
size of plasma pools used for the extraction of therapeutic proteins such as anti-hemophilic factor). I
have continued to participate in scientific advisory boards, including chairing the safety committee
of LFB (the plasma fractionator in France), co-chairing the scientific research committee of a
pharmaceutical consortium to award research contracts, and advising the EuroCJD committee on
global BSE and CJD surveillance, and the Argentine Agriculture Department on BSE issues. I have
also continued to accept invitations to chair and/or lecture at numerous scientific meetings on TSEs
in the Americas and Europe.
I am a member of the American College of Physicians, the American Epidemiological
Society, the Infectious Diseases Society of America, the American Society for Virology, the Société
Française de Neurologie, and the American Neurological Association. I have authored or coauthored
nearly 400 papers, mainly dealing with TSE, and especially the topics of epidemiology,
infectivity, and inactivation. (A list of scientific papers (published from 1991 to the present or that
are in press) of which I am an author, primarily regarding TSEs, is attached as Attachment A.) Since
1990, I have been an Associate Editor of the European Journal of Epidemiology, and from 1991 until
1997, was an Associate editor of the Journal of the Neurological Sciences.
3. Before entering the NIH in the US Public Health Service, I attended Harvard College
(A.B., Magna cum Laude), and the Johns Hopkins School of Medicine (M.D., Alpha Omega Alpha
Honor Society), and undertook Medical Internship and Residency training at both the Johns Hopkins
Hospital in Baltimore, Maryland, and the University of California School of Medicine in San
Francisco, California. I am a Diplomate of the American Board of Internal Medicine.
(My curriculum vitae is attached to this declaration as Attachment B.)
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 3 of 47

-3-
4. At the request of William L. Miller of the William Miller Group, PLLC (outside
counsel for Creekstone Farms Premium Beef, LLC), on October 11, 2004, I agreed to prepare this
declaration regarding the current scientific understanding of bovine spongiform encephalopathy
(BSE) in support of the litigation by Creekstone Farms Premium Beef, LLC to be allowed to
voluntarily test for BSE in cattle processed at its plant in Arkansas City, Kansas. Prior to October
11, I have had no relationship with Creekstone Farms. The opinions expressed in this declaration are
based solely on my knowledge of BSE and other TSEs that I have gained from my experience as a
physician and neuroscientist over the past 45 years.
5. Based on current science, we do not know with certainty how far in advance of
displaying clinical signs of BSE a bovine animal could test positive using a BSE rapid test such
as the rapid test technology developed by Bio-Rad Laboratories, Inc., and currently used by the
United States Department of Agriculture to test for BSE. For example, the Canadian Food
Inspection Agency (CFIA) recently issued a report on a 50-month-old cow from Alberta, Canada
that on July 13, 2006 was confirmed as BSE-infected. The CFIA reports states as follows:
This animal was detected and diagnosed with BSE during a pre-clinical phase of the
disease. The normal disease course to expression of clinical signs in this animal would be
expected to have included an additional three to six months of incubation followed by an
additional one to two months of clinical expression prior to being recognized as
symptomatic of BSE and targeted for testing. Had an unrelated disease not hastened her
entry into the surveillance stream, this animal would most likely have demonstrated
clinical signs sometime between 54 and 56 months, not significantly different from the
age range of previous cases.
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 4 of 47

-4-
Canadian Food Inspection Agency, Report On The Investigation Of The Seventh Case Of
Bovine Spongiform Encephalopathy (BSE) In Canada, available at
http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ab2006/7investe.shtml.
Thus, in this instance, had the cow not succumbed to an unrelated disease and had a brain stem
sample submitted for BSE testing, it would probably have been four to eight months longer
before the cow would have displayed symptoms that might have caused it to be tested because of
suspicion of BSE.
6. Experimental studies to determine range of intervals between positive tests and the
onset of clinical signs have not been done (a critical experiment has in fact been done in the UK,
but only infectivity was measured, and tests for the presence of prion protein have not been
done). Wells, G. A. H., S.A. Hawkins, R.B. Green, A.R. Austin, I. Dexter, Y.I. Spencer, M.J.,
Chaplin, M.J. Stack, and M Dawson, 1998, Preliminary observations on the pathogenesis of
experimental bovine spongiform encephalopathy (BSE): an update, Vet. Rec. 142:103-106;
Wells, G.A.H., J. Spiropoulos, S.A.C. Hawkins, and S. J.Ryder, 2005, Pathogenesis of
experimental bovine spongiform encephalopathy: preclinical infectivity in tonsil and
observations on the distribution of lingual tonsil in slaughtered cattle, Vet. Rec. 156:401-407.
Equally important, field experience in countries that have gone to universal testing (including
universal testing above a certain age) has shown that such testing (active surveillance) identifies
considerably more cases than only testing cattle whose behavior happens to attract the attention
of authorities happens to attract the attention of authorities (passive surveillance).
Report on the Monitoring and Testing of Ruminants for the Presence of Transmissible
Spongiform Encephalopathy (TSE) in the EU in 2005, Final Annual Report, 2005, European
Commission, 20 June 2006. (Section 4.2, Chart B2), available at
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 5 of 47

-5-
http://ec.europa.eu/food/food/biosafety/bse/annual_reps_en.htm.
7. Assumptions about the likely course of BSE infection in cattle and its significance for
potential vCJD infection in humans who consume cattle tissues are largely just that—
assumptions or extrapolations from limited data, not tested conclusions. We have little or no
direct evidence of such things as when in life a bovine is most susceptible to BSE; how much
less susceptible, if at all, humans are than cattle; whether shorter incubation times in cattle are
the result of exposure to a high dose at a young age or some other factor(s) (such as genetic
susceptibility or the strain of prions); how many humans may ultimately be shown to have vCJD;
or how effective SRM removal is at reducing the risk of transmission of BSE from an infected
animal.
8. The question of the interval between when cattle may test positive for BSE and
when those cattle exhibit clinical signs of the disease has in any case been made irrelevant by the
recent discovery of atypical cases of BSE that usually occur in older asymptomatic animals that
for one reason or another are culled, and are then discovered to test positive. Thus, some cattle
that on visual inspection appear normal are infected, and this fact negates any argument about a
limited window of 'pre-clinical' positivity in BSE tests, as there are no signs leading to a
suspicion of infection. The only way that these cattle are identified as BSE-infected is through
testing. The frequency of such infections is not yet known, but so far has ranged from less than
1% all the way up to 15% of the total number of test positives. International Conference on
Prion Diseases of NeuroPrion, Network of Excellence, Prion2006, Turin, Italy, 4-6 October
2006, Book of Abstracts (hereinafter “Prion2006 Abstracts”), See
http://www.neuroprion.com/en/ev_prion2006.html; Brown P, McShane LM, Zanusso G,
Detwiler L, On the question of sporadic or atypical bovine spongiform encephalopathy and
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 6 of 47

-6-
Creutzfeldt-Jakob disease, Emerg. Inf. Dis., 2006, 12: 1816-21, in press, December 2006. (A
copy of the article is attached to this declaration as Attachment C.)
9. Although these cases of asymptomatic, atypical BSE have been found in older
cattle, we do not currently know the concentration and distribution of infection and infectivity
that might have been found in these cattle at an earlier age. Another issue concerns evidence that
atypical BSE may be more virulent for humans than typical BSE. This evidence comes from
experimental transmission studies in at least 4 different laboratories. All have shown more rapid
onset of disease (shorter incubation periods) following inoculation with atypical BSE than with
typical BSE, and in one study, BSE did not transmit at all. These studies involved the use of
wild-type mice, bovinized and humanized transgenic mice, and (most worrisome) non-human
primates as recipient animals. Prion2006 Abstracts, See
http://www.neuroprion.com/en/ev_prion2006.html.
10. We do not have any direct evidence of how few BSE prions need to be consumed
in order for a human to be at risk of vCJD. Just because the disease has not progressed far
enough in a bovine to produce clinical symptoms does not mean that there are insufficient
concentrations of BSE prions in that bovine's tissue to present a risk of vCJD if consumed. (In
fact, logic suggests the contrary, because it would imply that all of the people with vCJD were
infected by the consumption of meat products from cattle that were displaying signs of BSE at
the time of slaughter, which seems highly unlikely.) The available tests for BSE are generally
believed to have lower limits of detecting concentrations of prions that, if ingested, could cause
BSE in other cattle, or potentially vCJD in humans. In cattle, the minimum amount of tissue
needed to infect a cow by the oral route is only 0.001 gram (Dr. Gerald Wells, personal
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 7 of 47

-7-
communication), and this figure has been used for risk analyses in humans (a hypothesized
bovine to human 'species barrier' effect has never been documented).
11. Just because cattle are under 30 months of age does not mean that they present no
risk of BSE, both because of the facts discussed above about the uncertain relationship between
testing positive for BSE and having sufficiently concentrated prions to cause infection in
humans, and because BSE has been detected in younger cattle in Europe and Japan.
Additionally, the way that the age of cattle to be slaughtered is often determined (dentition) is
not very precise. As a matter of protecting animal and human health from the fatal consequences
as BSE, detecting even a handful of cases that otherwise would be missed is very valuable.
USDA requires testing of agricultural products for numerous diseases which are (thankfully)
extremely rare, such as E. coli.
12. The USDA has performed BSE tests on thousands of cattle younger than 30
months, including thousands that had no clinical signs of BSE.
13. Measures that the United States (and Canada) has put in place to reduce the
transmission of BSE have substantially reduced the risk in the United States, but have not
eliminated it. Experience has shown that the feed bans are incomplete, both because the bans are
limited and because of imperfect implementation.
14. Collecting additional BSE test data from cattle less likely to have detectable levels
of BSE (because they are younger and do not display other risk factors), while not as costeffective,
is not worthless and produces data that could help better understand BSE and its
distribution in U.S. cattle. (For example, if authorities only tested cattle suspected of having
BSE, the Canadians would not have found BSE in the 50 month old Alberta cow that did not
have outward signs that might have suggested BSE and was born long after exposure to BSE in
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 8 of 47

-8-
cattle feed was believed to have ceased; nor is it likely that either of the two indigenously
infected US cows with atypical BSE that tested positive would have been identified.) Evolving
knowledge about atypical BSE, where there are only rarely outward signs that might cause the
animal to be singled out and tested based on suspicion of BSE, makes the value of testing
asymptomatic cattle even clearer. Voluntary testing does not interfere with or dilute government
efforts to test for BSE and to understand the disease. Additionally, while most cattle slaughtered
in the U.S. are under 30 months of age, many thousands every year are over 30. I am not aware
of any other programs under which USDA has prohibited testing for a disease because it is
unlikely that the disease will be found.
15. The USDA recently announced a dramatic (ten-fold) reduction in the number of
cattle it will test for BSE. USDA plans to reduce the current annual rate of over 400,000 cows to
only 40,000 (less than 1 % of the cattle that are slaughtered or die each year). USDA News
Release No. 0255.06, July 20, 2006, available at
http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2006/
07/0255.xml. Preventing voluntary testing while at the same time dramatically reducing
government testing does not make any sense for the protection of animal and human health and
is further indication that voluntary BSE testing is not "worthless." Although the USDA and the
OIE have stated that targeted testing of cattle most likely to have BSE is the most effective way
of detecting and monitoring BSE infection in a country's cattle herd, most developed countries
known to have BSE nonetheless have chosen to go far beyond such targeted testing in their
domestic BSE monitoring programs, especially in view of the growing proportion of infected
cattle that have atypical (and asymptomatic) forms of BSE when slaughtered.
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 9 of 47

-9-
16. BSE tests do not involve the immune system of the animal that is tested. There is
a sharp distinction between using immunological means to prevent foreign pathogen infections
(e.g., active and passive immunization) and the use of an immunologic reagent (e.g., an
antibody) to detect infectious prion proteins obtained from the body of an infected host. The use
of such a test has nothing whatsoever to do with the immune system of the infected (and now
dead) animal. USDA thinking on this point is very confused.
17. The USDA allows suppliers of meat and other products to certify that those
products meet criteria unrelated to food safety (or least, where USDA does not have data to
conclude that there is a food safety benefit). I believe this is true, for example, of "organic,
"natural," "hormone-free, "grass-fed," and other descriptors that USDA allows. Given the
legitimate role of the USDA to protect consumers from industry incompetence, it nevertheless
seems unreasonable for USDA to prohibit the private use of its own validated test method. The
desire on the part of some consumers to have a higher standard of safety with respect to what
they eat should not be circumvented by this kind of attitude, even if most people are satisfied
with government assurances of safety based on its own evaluation.
I declare under penalty of perjury that the foregoing is true and correct.
Executed on October 27, 2006. Paul Brown, M.D.
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 10 of 47

ATTACHMENT A
Paul W. Brown, M.D.
List of Publications 1991 to Present
Case 1:06-cv-00544-JR Document 14-9 Filed 11/03/2006 Page 11 of 47

Paul W. Brown, M.D.
LIST OF PUBLICATIONS 1991 TO PRESENT

SNIP...END...TSS
 
Top