Petition for Writ of Certiorari — Nebraska Beef, Ltd. v. Greening (No. 04-1611)

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gn The

Supreme Court of ithe GAnited States

NEBRASKA BEEF, LIMITED,

Petitioner,

Vv.

DENNIS GREENING, ET AL.,

Respondents.

On Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Eighth Circuit

PETITION FOR A WRIT OF CERTIORARI

WILLIAM M. LAMSON, JR.*

BRIAN J. BRISLEN

ANASTASIA WAGNER

LAMSON, DUGAN AND Murray, LLP

10306 Regency Parkway Drive

Omaha, NE 68114

t: (402) 397-7300

f: (402) 397-7824

*Counsel of Record

Counsel for Nebraska Beef,

Limited, Petitioner ‘

COCKLE LAW BRIEF PRINTING CO. (800) 225-6964

OR CALL COLLECT (402) 342-2831

QUESTIONS PRESENTED

This Petition presents two questions for review by this

Court. Resolution of the first may obviate the need to

address the second. Nonetheless, both issues independ-

ently present an important question on which circuit

courts have divided and, in the interest of judicial confor-

mity, need resolution. The questions presented are as

follows:

I. Is it permissible for an appellate court to decide

whether a Bivens cause of action exists against vari-

ous levels of employees of the United States Depart-

ment of Agriculture for violations of a private meat

packing company’s constitutional rights when the ex-

istence of a Bivens remedy is not necessary to deter-

mine whether a plaintiff alleged a violation of a

constitutional right of which a reasonable’ person

would be aware and the only basis for the appellate

jurisdiction is an interlocutory appeal of a denial of

qualified immunity under Mitchell v. Forsyth?

Does a cause of action under Bivens exist against

various levels of employees of the United States De-

partment of Agriculture for violations of a private

meat packing company’s constitutional rights when

there is no adequate administrative remedy for the

constitutional violations?

PARTIES TO THE PROCEEDING

Pursuant to Rule 14.1(b), the following list identifies

all of the parties appearing here and before the United

States Court of Appeals for the Eighth Circuit.

The petitioner here and appellee below is Nebraska

Beef, Limited.

The respondents here and appellants below are

Dennis Greening, Ronald Seitz, Chander Dev, Duane

Shonka, Michael Fast, John Doe 1, John Doe 2, Jane Doe

1, and Jane Doe 2.

CORPORATE DISCLOSURE STATEMENT

Pursuant to Rule 29.6, Petitioner state as follows:

There is no parent corporation of Nebraska Beef, Ltd.,

or a publicly held corporation that owms 10% or more of its

stock.

TABLE OF CONTENTS

I TIE iain sce scitinicicstnsvnsnsescecasannenccedenocannn sestesseseenees

Jurisdiction

Statutes involved

Code of Federal Regulations involved

Statement of the case

A. Factual background

B. Proceeding below

Reasons for granting the petition

This case presents an opportunity for this

Court to prevent further erroneous application

of its qualified immunity precedent as it re-

lates to pendent appellate jurisdiction and to

resolve circuit conflict and uncertainty regard-

ing the breadth of interlocutory jurisdiction

following a common Mitchell-type appeal

A. The Eighth Circuit’s opinion conflicts in

principle with Supreme Court precedent...

B. The Eighth Circuit’s opinion directly con-

flicts with other circuit courts of appeals...

This case presents an opportunity to ensure

uniform application of law, resolve a circuit

court division and decide a now unsettled area

of Bivens precedent

A. The Eighth Circuit’s decision departs from

other circuit courts of appeals

B. Existence of a Bivens remedy against

USDA employees

TABLE OF AUTHORITIES

CASES:

Behrens v. Pelletier, 516 U.S. 299 (1996)

Bivens v. Six Unknown Named Agents of the Fed-

eral Bureau of Narcotics, 403 U.S. 388 (1971)....... passim

Butz v. Economou, 438 U.S. 478 (1978)

Carlson v. Green, 446 U.S. 14 (1980)

Drake v. Scott, 812 F.2d 395 (8th Cir. 1987), aff’d

on reh’g, 823 F.2d 239 (8th Cir. 1987)

Garrett v. Hawk, 127 F.3d 1263 (10th Cir. 1997) ... 24, 25, 26

Hurt v. United States, 889 F.Supp. 248 (S.D.W.Va.

Jackson v. DeTelia, 998 F.Supp. 901 (N.D. Ill. 1998)

Johnson v. Jones, 515 U.S. 304 (1995)

Judicial Watch, Inc. v. Rossotti, 217 F.Supp.2d 618

(D.Md. 2002)

Krusinski v. USDA, 4 F.3d 994 (Table), 1993 WL

346858 (6th Cir. 1993), reprinted at Pet. App.

78a-88a

Lacey v. C.S.P. Solano Medical Staff, 990 F.Supp.

1199 (E.D.Cal. 1997)

Leatherman v. Tarrant County Narcotics Intelli-

gence and Coordination Unit, 507 U.S. 163

(1993)

Love v. United States, 915 F.2d 1242 (9th Cir. 1989) ... 20, 24

Lunsford v. Jumao-As, 155 F.3d 1178 (9th Cir. 1998)

TABLE OF AUTHORITIES — Continued

McBride Cotton & Cattle Corp. v. Veneman, 290

F.3d 973 (9th Cir. 2002)

Mitchell v. Forsyth, 472 U.S. 511 (1985) 2, 7,9, 12, 14

National Commodity and Barter Assoc. v. Gibbs,

&86 F.2d 1240 (10th Cir. 1989)

Pelletier v. Federal Home Loan Bank of San Fran-

cisco, 968 F.2d 865 (9th Cir. 1992)

Rumbles v. Hill, 182 F.3d 1064 (9th Cir. 1999)

Schweiker v. Chilicky, 487 U.S. 412 (1988)

Sheehy v. Wehlage, 2004 WL 951367 (W.D.N.Y. Feb.

3, 2004)

Siegert v. Gilley, 895 F.2d 797 (D.C. Cir. 1990)

Siegert v. Gilley, 500 U.S. 226 (1991)... eee passim

Sinclair v. Hawke, 314 F.3d 934 (8th Cir. 2003)

Triad Associates, Inc. v. Robinson, 10 F.3d 492 (7th

Cir. 1993)

Western Center for Journalism v. Cederquist, 235

F.3d 1153 (9th Cir. 2000)

Veal Connection Corp. v. Thompson, Docket C 96-

04486 CW, reprinted at Pet. App. 89a-145a

STATUTES:

7 U.S.C. § 6912(e) 1, 10, 23

a SF ds Se Se Oe NS ike doccicineicactcitasiisinasdeanceneanauniaas 1

28 U.S.C. § 1254(1)

TABLE OF AUTHORITIES — Continued

Page

OTHER AUTHORITIES:

rgek i EPR) of fF ” eeere ‘Asainniaisadcdiihaiiins apa bibickadiges nes le 23

7 C.F.R. § 1.133(b)(1)

7 C.F.R. § 1.1501

9 C.F.R. § 416.12

9 C.F.R. pt. 417

Fed.Reg. 28041, vol. 69, no. 96, May 18, 2004

OPINIONS BELOW

The opinion of the Court of Appeals is reported at 398

F.3d 1080, and is reprinted in the Appendix to the Petition

(“Pet. App.”) at la-8a. The District Court’s opinion is

reported at 2004 WL 546900, and is reprinted at Pet. App.

9a-20a.

JURISIDICTION

The Court of Appeals entered its judgment on Febru-

ary 28, 2005. This Court has jurisdiction under 28 U.S.C.

§ 1254(1).

STATUTES INVOLVED

This case involves provisions of the Federal Meat

Inspection Act, 21 U.S.C. 601 et seg., reprinted in the

appendix at Pet. App. 2la-53a, and 7 U.S.C. § 6912(e),

reprinted in the Appendix at Pet. App. 77a.

CODE OF FEDERAL REGULATIONS INVOLVED

This case involves provisions of the Code of Federal

Regulations, relevant provisions of which are reprinted in

the Appendix at Pet. App. 53a-77a.

STATEMENT OF THE CASE

The United States Government is charged with

monitoring and ensuring food safety. This case involves

one of the most important industries ir the United States

— Food Manufacturing. Specifically, this case presents a

Bivens’ type constitutional rights challenge by a manufac-

turer of this nation’s food supply against the individual

government employees who oversee the process. The

issues presented herein are not unique to the food manu-

facturing industry but are also implicated in any case

where an individual seeks redress for violations of their

constitutional rights or where a government employee

claims to be qualifiedly immune from suit.

The twe important issues for this Court to resolve

have each evidenced a ready capability for repetition and

have caused an acknowledged confusion and complication

in the circuit courts. The first, concerning the scope of

review available following the denial of qualified immunity

and an interlocutory appeal under Mitchell,’ requires

resolution to resolve a split among various circuit courts of

appeals. The second presents an important federal ques-

tion regarding the existence of a Bivens remedy against

United States Department of Agriculture (“USDA”) em-

ployees for constitutional violations in the context of a suit

against individual federal meat inspectors. These two

important legal issues pertain not only to the respective

rights of various manufacturers in the food industry but

rights held by every individual bringing a Bivens type

claim (or with respect to the qualified immunity issue, a

§ 1983 claim) against a government employee for violating

constitutional nights.

‘ Bivens v. Six Unknown Named Agents of the Fed. Bureau of

Narcotics, 403 U.S. 388 (1971).

* Mitchell v. Forsyth, 472 U.S. 511 (1985).

A. Factual Background

This case was decided, and ultimately dismissed, by

the Eighth Circuit on the two legal issues stated above

following a motion to dismiss. Thus, there is no factual

record outside of petitioner’s initial Complaint. Accord-

ingly, for the purposes of their motion to dismiss, and

subsequent appeal, the respondents must admit all well

pleaded facts contained in petitioner’s Complaint. Like-

wise, petitioner is entitled to all reasonable inferences

drawn therefrom. See Leatherman v. Tarrant Cty. Narcot-

ics Intelligence and Coordination Unit, 507 U.S. 163, 164

(1993). Though the facts of this matter are not necessary

for ultimate determination of the issues presented herein,

the brief recitation below will aid in understanding the

context for this Bivens action.

Respondents in this action are employees at various

levels within the USDA, Food Safety and Inspection

Service (“FSIS”). Petitioner is the United States’ largest

privately owned meat packing and processing plant,

slaughtering and processing approximately 2,300 beef

cattle per day. Prior to commencing operation in October

1995, petitioner applied for, and received, the grant of

federal meat inspectors to inspect and mark its products

as USDA approved for wholesomeness. Such inspections

ensure petitioner is following federally mandated proce-

dures regarding sanitation and conducting business in a

way that provides for unadulterated product being dis-

tributed to the public for consumption. Since inception,

petitioner has worked with and cooperated with the USDA

to ensure it produces the highest quality product. The

USDA has tested samples of petitioner’s product for

adulterants, and petitioner has conducted its own testing

for adulterants and pathogens in conjunction with the

USDA's testing, all of which have been negative. Through-

out petitioner’s history, no consumer death or illness

related to adulterated beef has been attributed to any

product processed by petitioner.

In August 2002, petitioner was informed that the

USDA was going to conduct an assessment as a food safety

exercise in petitioner’s facilities with petitioner’s coopera-

tion. Respondent Greening assured petitioner that no

FSIS enforcement action could, in any way, result from the

assessment. On September 3, 2002, seven FSIS represen-

tatives appeared at petitioner’s plant to cor.duct what they

termed as a “public health assessment.” Following the

assessment, and despite Respondent Greening’s asser-

tions, the FSIS notified petitioner of the USDA's consid-

eration to suspend FSIS inspections at petitioner’s facility

based on certain alleged deficiencies in petitioner’s

HACCP and SSOP systems. See 9 C.F.R. § 416.12; 9 C.FR.

§ 417 et seq., Pet. App. 53a-65a. In the week following the

suspension, petitioner worked to resolve the FSIS per-

ceived issue and met with USDA officials for over three

hours via teleconference. Acting Associate Deputy Secre-

tary Barbara Masters communicated that she had con-

ferred with the Des Moines USDA District Office and was

of the opinion that the issues between the USDA and

petitioner would be resolved without lost production time.

However, after the meeting, the Des Moines District Office

provided petitioner with oral notification that petiticner’s

response was inadequate to avoid a suspension of produc-

tion activities and that it was immediately suspending

production activities at the facility, despite acknowledgement

by the FSIS that there was no public food safety issue pre-

sent which would warrant the closing of petitioner’s opera-

tions. This suspension of production activities at the plant

effectively prohibited petitioner from fulfilling its com-

mitments to customers, resulting in the loss of employ-

ment to 1,100 employees and roughly $2,750,000.00 a day

in lost revenues.

From September 3, 2002, to September 17, 2002, the

date upon which the suspension was placed in abeyance,

petitioner was subject to an increased, arbitrary and

capricious level of regulatory actions pertaining to its pro-

duction operations by USDA inspection personnel and upper

management. This increased, arbitrary and capricious level

of regulatory actions has continued to the date of filing of

this Bivens action and beyond. Respondents have continued

to subject petitioner to periods of suspension despite know]}-

edge that no food safety issue is present. This increased,

arbitrary and capricious level of regulatory actions is further

evidenced by the inspectors’ issuance of 58 Non-Compliance

Reports (““NRs”) for alleged failure to operate its business in

accordance with federal regulations despite petitioner having

operated its business in a consistent and continuous manner.

Petitioner’s complaint sets forth the precise nature of many

of these arbitrary and capricious acts.

Petitioner asserts that respondents engage in these

flagrant violations of federal regulations and guidelines for

one or more of the following reasons: a) in furtherance of a

conspiracy between respondents to retaliate against other

FSIS inspectors who either were working, or had worked

at petitioner’s plant; b) by the desire and in an effort to

gain promotions within the USDA ranks; c) by the desire

and in an effort to increase overtime opportunities for.

themselves and fellow inspectors; d) in retaliation and as

intimidation against petitioner for questioning USDA

authority and enforcement actions and decisions; e) in an

effort to arbitrarily and capriciously select petitioner as an

example of tougher, arbitrary and capricious food safety

standards in order to enhance the USDA's public percep-

tion and each individual respondent’s status within the

USDA in response to negative publicity from high profile

food recalls; and f) in an arbitrary, capricious and mali-

cious manner to deprive petitioner of its constitutionally

protected right to Due Process of Law, Equal Protection of

Law, Free Speech and to petition the government for

Redress of Grievances.

Contrary to statements contained in the Eighth

Circuit opinion, petitioner did not bring this action to

challenge the validity or appropriateness of the NRs

issued by the respondents. Rather, petitioner asserts that

respondents intentionally, knowingly or recklessly violated

petitioner’s constitutional rights. NRs are simply one of

the mediums through which petitioner’s rights have been

violated. In other words, the individual NRs are not the

subject of this litigation; rather they merely evidence the

animus toward petitioner and are indicative of the arbi-

trary and capricious acts of respondents.

B. Proceeding Below

Petitioner, the largest privately owned meatpacking

company in the United States, brought this Bivens action

against nine individual employees of the USDA FSIS to

remedy viclations of its constitutional mght to Due Proc-

ess, Freedom of Speech and to Redress Grievances. In the

district court, the respondents filed a motion to dismiss

the action under Fed.R.Civ.P 12(b)(1) and 12(b)(6) based

upon several theories which included lack of standing

(under 12(b)(1)), failure to exhaust administrative reme-

dies (under 12(b)(1)), nonavailability of a Bivens remedy

(under 12(b)(6)) and based upon their claim of qualified

immunity (under 12(b)(6)). The district court denied the

motion to dismiss on each theory. Pet. App. 9a-20a.

The respondents appealed to the Eighth Circuit based

upon the rule first announced in Mitchel! allowing interlocu-

tory appeals to decide claims to qualified immunity. Despite

the interlocutory nature of its appeal, the respondents also

asked the Eighth Circuit to decide whether a Bivens remedy

existed. The petitioner contested the Eighth Circuit’s juris-

diction to decide the Bivens issue on a Mitchell-type inter-

locutory appeal. The Eighth Circuit held that it had

jurisdiction to decide the Bivens issue and found that there is

no Bivens remedy that can be brought against federal meat

inspection personnel. Thus, the Eighth Circuit, without

addressing qualified immunity, remanded the matter to the

district court with instructions to dismiss the case.

With regard to the threshold jurisdictional issue the

Eighth Circuit noted that the Supreme Court first recog-

nized jurisdiction over an interlocutory appeal from a

denial of qualified immunity in Mitchell, supra. It also

noted its circuit precedent that allowed it to decide “closely

related issues of law” when receiving a qualified immunity

interlocutory appeal. Pet. App. 3a, citing, Drake v. Scott,

812 F.2d 395, 399 (8th Cir. 1987), aff’d on reh’g, 823 F.2d

239 (8th Cir. 1987). The court explained that in Drake the

defendants asserted a qualified immunity defense and

argued that plaintiff's due process claim failed as a matter

of law because Drake had no property interest. Pet. App.

3a, citing, Drake, 812 F.2d at 398. The Drake court rea-

soned that if the plaintiff did not possess a pronerty

interest he could not succeed on his claim, and thus, the

issue of qualified immunity need not be decided. Pet. App.

3a, Drake at 399. However, the Eighth Circuit ignored the

fact that in deciding the qualified immunity issue which

allowed for interlocutory appeal, the Drake court had to

look at whether there was a clearly established constitu-

tional right; i.e. a property interest. Therefore, Drake

appropriately assumed jurisdiction over the question of

whether there was a cause of action alleged because it

necessarily had to decide that issue in addressing qualified

immunity. Conversely, here, the Eighth Circuit did not

have to decide the availability of a remedy in order to

decide whether petitioner stated a violation of a known

constitutional right.

The court below also chronicled this Court’s decisions

pertaining to the scope of appellate jurisdiction following a

qualified immunity appeal. Specifically, the court exam-

ined Siegert v. Gilley, 500 U.S. 226 (1991), Johnson v.

Jones, 515 U.S. 304 (1995) and Behrens v. Pelletier, 516

U.S. 299 (1996). The court noted that in Siegert this Court

instructed that “[a] necessary comitant to the determina-

tion of whether the constitutional right asserted by a

plaintiff is ‘clearly established’ at the time the defendant

acted is the determination of whether the plaintiff has

asserted a violation of a constitutional right at all.” Pet.

App. 4a, citing, Siegert, 500 U.S. at 232. Then, in Johnson,

this Court “cautioned against expansive jurisdiction” and

held that a question involving only evidence sufficiency,

i.e., which facts a party may be able to prove at trial, is not

appealable. Pet. App. 4a-5a, citing, Johnson, 515 U.S. at

313. It also noted Johnson’s emphasis on the interests of

judicial economy. Pet. App. 4a-5a. Finally, the court below

turned to Pelletier for the proposition that “summary

judgment determinations are appealable when they

resolve a dispute concerning an abstract issue of law

relating to qualified immunity - typically, the issue

whether the federal right allegedly infringed was ‘clearly

established.” Pet. App. 5a (emphasis original) citing,

Pelletier, 516 U.S. at 3138.

Despite the common thread of the cited cases, which

demonstrates that the issue deemed to be “inextricably

intertwined” such to confer expanded Mitchell jurisdiction

was particular to the violation of a clearly established

constitutional right, the Eighth Circuit departed from

Supreme Court precedent and other circuit courts to

determine that it had jurisdiction to decide the availability

of a Bivens remedy. The Eighth Circuit contended that the

existence of a Bivens remedy is “a purely legal question

that presents none of the judicial economy concerns

addressed in Johnson.” Pet. App 5a-6a. It noted that if the

case were remanded, the respondents would be subject to

the costs and time of litigating a lawsuit which, if no

Bivens remedy exists, is doomed from its inception. Pet.

App. 6a. Thus, it determined it had jurisdiction to decide

the Bivens issue.

In doing so, the Eighth Circuit noted that this Court

has been “wary of extending Bivens remedies into new

contexts... .” Pet. App. 6a-7a citing, Schweiker v. Chilicky,

487 U.S. 412, 421 (1988). Specifically, the court noted that

this Court has not extended Bivens remedies “‘[w\hen the

design of a Government program suggests that Congress

has provided what it considers adequate remedial mecha-

nisms for constitutional violations that may occur in the

course of its administration.” Pet. App. 7a citing,

Schweiker, 487 U.S. at 421. The court further noted its

circuit precedent that the denial of a Bivens remedy has

been upheld even when the remedial mechanisms for

constitutional violations do not provide complete relief.

Pet. App. 7a citing, Sinclair v. Hawke, 314 F.3d 934, 940

(8th Cir. 2003).

Ultimately, to the Eighth Circuit, it was irrelevant

that not only do the remedial mechanisms set forth by

Congress in relation to federal meat inspection provide

incomplete relief to petitioner, but the mechanisms in fact

provide no relief at all. Instead, the court focused its

decision on three factors. First, that Congress has not

explicitly created any direct right of action against USDA

employees alleged to have committed constitutional

violations. Pet. App. 7a. Second, the USDA promulgated a

comprehensive regulatory scheme pursuant to the FMIA

that includes the right to judicial review under the APA.

Pet. App. 7a-8a. Finally, Congress has created a “strin-

gent” exhaustion requirement for grievances filed against

USDA employees. Pet. App. 8a citing, 7 U.S.C. § 6912(e).

With that, the Eighth Circuit remanded the action to the

district court with instructions to dismiss the complaint

for failure to state a claim upon which relief can be

granted, thus denying petitioner any remedy for violations

of rights protected by the United States Constitution.

REASONS FOR GRANTING THE PETITION

This Petition presents two independently important

legal issues both of which pertain not only to the respec-

tive rights of various manufacturers in the food industry

but rights held by every individual bringing a Bivens type

claim against a government employee for violating consti-

tutional rights. The first issue, which has an even broader

applicability, is whether, after asserting a qualified immu-

nity defense, a government employee can request, and

ultimately have an appellate court decide, if there is even

a cause of action available under the plaintiff’s theory of

liability. This issue has sweeping implications which

involve every qualified immunity defense put forth in any

case; including Bivens cases and § 1983 claims. Essen-

tially, the Eighth Circuit has opened the door for an

immediate interlocutory review of whether there exists a

Bivens remedy in all cases purporting to bring one. Its

decision in that regard is in direct conflict with other

circuit court opinions.

Second, if jurisdiction was proper, this Petition pre-

sents the issue of whether there is a remedy, under Bivens,

available to those whose constitutional mnghts have been

violated by USDA inspectors. While the holding below was

particular to federal meat inspectors, the decision has

implicated nearly every federal program that also has a

statutory or regulatory mechznism for administrative

appeal of some aspect of its regulatory function. With its

opinion in this case the Eighth Circuit has stated that no

remedy exists, even if there is absolutely no administra-

tive relief available to remedy the constitutional harm

alleged, as long as there is some mechanism for adminis-

trative appeals. Again, the Eighth Circuit’s opinion on this

important issue is at odds with other jurisdictions which

have expressly allowed Bivens actions against regulatory -

officials including USDA meat inspectors.

This case presents an opportunity for this

Court to prevent further erroneous application

of its qualified immunity precedent as it re-

lates to pendent appellate jurisdiction and to

resolve circuit conflict and uncertainty regard-

ing the breadth of interlocutory jurisdiction

following a common Mitchell-type appeal.

A. The Eighth Circuit’s opinion conflicts in

principle with Supreme Court precedent.

The immunity claim presented by the respondent

inspectors in this case is distinct from the other defenses

they presented to the District Court. The immunity

defense alone can be characterized as a defense that is

finally determined by the Court and “effectively lost if the

case is erroneously permitted to go to trial.” Siegert v.

Gilley, 500 U.S. 226, 233 (1991), quoting, Mitchell, 472

U.S. at 526 (emphasis added). This is the point missed by

the Eighth Circuit’s ruling. If qualified immunity is not

immediately appealable, all benefit of the defense (not

having to participate in discovery or stand trial at all) is

forever lost. However, while the result may ultimately be

the same, the rationale for interlocutory appellate review

is no different for whether there is a Bivens remedy than it

is for any other dispositive issue.

Unlike qualified immunity there is no right not to

stand trial on a Bivens theory that would be lost by not

having immediate appeal of the existence of a Bivens

remedy. If a district court says there is a cause of action

under Bivens, the case goes to trial and a defendant can

appeal on that basis if they lose. The Eighth Circuit’s

ruling means that every decision, at the district court

level, to allow a Bivens cause of action (or any other cause

of action to which qualified immunity is a defense) will be

immediately appealable — as long as the defendant also

asserts a qualified immunity defense. Again, that is a

flawed premise because, just like other “failure to state a

cause of action” cases, there is no right to not have to go

through trial if the district court erroneously allows the

Bivens case to go forward.

Indeed it is no different than any defendant claiming

that the statute of limitations has run or that a plaintiff

lacks standing. See Triad, 10 F.3d at 492. Certainly imme-

diate appeal could be judicially economical. But judicial

economy is not the only consideration. The real test is

what right would be lost. With qualified immunity the

defendant has a right to be free from standing trial or

participating in discovery if the plaintiff fails to properly

allege that they violated a constitutional right of which a

reasonable person in their position would be aware. There

is no corresponding right not to stand trial or participate

in discovery in instances where a district court rules that

the plaintiff did state a valid cause of action.

The Eighth Circuit is confusing the assertion of a

constitutional right with the remedy available for a

violation of that right. Siegert states that “[a] necessary

comitant to the determination of whether the constitu-

tional right asserted by a plaintiff is ‘clearly established’ _at—

the time the defendant acted is the determination of

whether the plaintiff has asserted a violation of a constitu-

tional right at all.” Siegert, 500 U.S. at 232. Therefore, if a

court decides that there is no constitutional right, it

indeed follows a fortiori that there could be no “clearly

established” constitutional right and thus, not only is the

defendant entitled to qualified immunity but there is no

cause of action to begin with. Such is a proper decision

based upon an issue that is “inextricably intertwined” with

the qualified immunity issue.

But to extend that rationale to whether or not there is

a remedy of a clearly established constitutional right

conflicts with this Court’s precedent, violates the final

judgment rule and is an impermissible exercise of jurisdic-

tion. The remedy for a constitutional violation has nothing

to do with the existence of a constitutional right, and

therefore, it is not inextricably intertwined with the test

for qualified immunity. Specifically, whether the govern-

ment employee violated a clearly established constitu-

tional right of which a reasonable employee in that

position would be aware. Only when a decision on the

existence of the constitutional right necessarily encom-

passes whether a cause of action has been stated can an

appellate court assume jurisdiction under Mitchell of a

non-final order.

B. The Eighth Circuit’s opinion directly con-

flicts with other circuit courts of appeals.

In addition to the departure from Supreme Court

precedent, the Eighth Circuit’s order also departs from

other circuit court rulings. In order to resolve this conflict

among circuit courts, this Court should again “clarify the

analytical structure under which a claim of qualified

immunity should be addressed.” See, Siegert v. Gilley, 500

U.S. 226, 231 (1991). The Eighth Circuit ruled that when

an appellant takes immediate interlocutory appeal after a

denial of qualified immunity, the circuit court also has

immediate interlocutory jurisdiction to decide whether the

underlying cause of action states a viable claim. The

ruling completely ignores the final decision rule and

distorts the rule allowing immediate review of a denial of

qualified immunity; a rule applicable to both Bivens claims

and § 1983 actions brought against state officials. See Butz

v. Economou, 438 U.S. 478, 504 (1978).

Other circuit courts have correctly decided this issue,

and thus, have created a circuit split of which the Eighth

Circuit took some note. See Pet. App. 6a. For example, in

Kwai Fun Wong v. U.S., 373 F.3d 952 (9th Cir. 2004), the

Ninth Circuit Court of Appeals was faced with an appeal

of a denial of qualified immunity by defendants who were

sued under a Bivens theory of recovery. The appeal pre-

sented what it described as a set of “thorny procedural and

substantive questions implicating several areas of consti-

tutional and immigration law|.]” Kwai Fun Wong, 373 F.3d

at 956.

In Kwai Fun Wong, the Ninth Circuit first took note of

its undeniable jurisdiction under Mitchell which allowed it

to decide the qualified immunity issue. Jd. at 960. It also

specifically noted that the appellants raised “several

additional issues not ordinarily reviewable on interlocu-

tory appeal.” Jd. In order to reach the “additional issues”

the Ninth Circuit explained its ability to exercise pendent

appellate jurisdiction over those otherwise nonappealable

rulings if they are “inextricably intertwined” with a claim

properly brought on interlocutory appeal. Kwai Fun Wong,

373 F.3d at 960. The Ninth Circuit explained that issues

are inextricably intertwined if they are “‘(a) [] so inter-

twined that we must decide the pendent issue in order to

review the claims properly raised on interlocutory appeal,

or (b) resolution of the issue properly raised on interlocu-

tory appeal necessarily resolves the pendent issue.” Jd.

(citation omitted).

One of the “pendent” issues the defendant/appellants

asked the Ninth Circuit to address was whether a Bivens

remedy existed against the individual Immigration and

Naturalization agents because, the defendant/appellants

urged, the Immigration and Naturalization Act is a com-

prehensive remedial scheme intended to preclude a dam-

ages remedy. Jd. at 961. The court clearly and simply

stated that “interlocutory review of this issue is not

available.” Id. citing, Pelletier v. Fed. Home Loan Bank of

San Francisco, 968 F.2d 865, 871 (9th Cir. 1992). It coft-

tinued by appropriately pointing out that “|djeciding this

question requires the consideration of entirely distinct

legal standards from, and its resoiution is not a logical

predicate to the resolution of. the qualified immunity

issue.” Kwai Fun Wong, 373 F.3d at 961.

The court also pointed out that a decision on whether

a Bivens remedy was available is distinguishable from

those instances where an appellate court needs to deter-

mine the validity of the action brought in order to estab-

lish that the district court had jurisdiction to issue its

order in the first place. It noted that “‘[Jurisdiction] is not

defeated ... by the possibility that the averments might

fail to state a cause of action on which petitioners could

actually recover. Whether the complaint states a cause of

action on which relief could be granted is a question of law

and ... must be decided after and not before the court has

assumed jurisdiction over the controversy.’” Jd. (citations

omitted). Therefore, because the court did not need to

resolve the issue in order to determine that jurisdiction

existed over the matter in the first place, it held that it

could not review the district court’s decision to infer a

Bivens remedy. Id.

Further evidence of the unsettled nature of what is

appropriate for consideration on an interlocutory qualified

immunity appeal is presented in Triad Associates, Inc. v.

Robinson, 10 F.3d 492 (7th Cir. 1993). In Triad the Sev-

enth Circuit considered a claim to qualified immunity and

noted that “determining whether a plaintiff has asserted a

constitutional violation at all is ‘{a] necessary concomitant

to the determination of [qualified immunity]j.’” Triad, 10

F.3d at 496, quoting, Siegert v. Gilley, 500, U.S. 226, 232

(1991).° The court continued by explaining that deciding

the “purely legal question” of whether a constitutional

violation has been established permits courts to “weed out”

frivolous allegations. Triad, 10 F.3d at 496.

In a footnote to its rationale, the Seventh Circuit

noted that the appellant in 7riad was attempting to use

the quoted language in Siegert “as a springboard for now

appealing the district court’s rulings on otherwise noncur-

rently appealable issues|[,]” specifically, on his statute of

limitations defense and his standing defense. Triad, 10

F.3d at 496 n. 2. It is particularly telling in relation to this

case that later in footnote 2 the Seventh Circuit itself

suggests that the scope of its review under Siegert is not

entirely clear. Particularly, with regard to the standing

issue, the court noted that appellant was trying to charac-

terize his standing argument as an issue of “the reach of

the federal right.” Id. While the court disagreed with his

* The Seventh Circuit correctly interpreted its jurisdiction in

reviewing the appeal of a motion to dismiss, without a factual record, as

determining whether the allegation, if true, would amount to a viola-

tion of a constitutional right. In the present case, the Eighth Circuit

erroneously interprets its duty as determining whether the allegation of

a violation of a clearly established constitutional right can be made at

all because there is, or is not, an available remedy.

characterization it stated that “[iJf Robinson’s contention

were correct, then Siegert very well could indicate that it

would be proper to consider that issue on the merits now.”

Id. Thus, the Seventh Circuit indicates that the issue of

the appropriateness of review of the existence of a federal

right on a qualified immunity interlocutory appeal is not

clear.

Il. This case presents an opportunity to ensure

uniform application of law, resolve a circuit

court division and decide a now unsettled area

of Bivens precedent.

While petitioner believes the Eighth Circuit did not

have jurisdiction to decide whether a Bivens remedy

existed in this context, even if jurisdiction did exist, this

case presents an important issue for this Court’s consid-

eration independent of the qualified immunity issue. As is

discussed below, other circuit courts have allowed Bivens

actions against USDA employees in general and FSIS

meat inspectors specifically. To allow the Eighth Circuit’s

ruling in this case to stand would leave the meat process-

ing industry in a position where these located in the Sixth

or Ninth Circuits could raise a Bivens claim while those in

the Eighth Circuit could not. Likewise, the USDA itself

has acknowledged the availability of Bivens suits against its

employees and leaving this decision as it is leaves USDA

meat inspectors in different jurisdictions (Ninth and Sixth

circuits, see infra) working under different standards and

liabilities than those in other jurisdictions (Eighth). See Pet.

App. la-8a. Furthermore, those plants large enough to have

operations in multiple jurisdictions could potentially have

the option of bringing Bivens actions in certain jurisdictions

over others in order to circumvent adverse precedent

regarding the availability of a Bivens action.

A. The Eighth Circuit’s decision departs from

other circuit courts of appeals.

In Krusinski v. USDA, 4 F.3d 994 (Table), 1993 WL

346858 (6th Cir. 1993) (unpublished),* the Sixth Circuit

Court of Appeals considered the ~laims of a poultry plant

operator that the USDA iitseit, along with individual

inspectors named as defendants, violated his constitu-

tional rights to due process and equal protection. Pet. App.

79a. Specifically the plaintiff alleged several instances

where the inspectors made him perform work that was not

required and compelled him to clean up cigarette butts

and other refuse left by the inspectors. He further alleged

that his plant operations were continually and unjustly

being shut down so that he could comply with the inspec-

tors’ orders, resulting in lost profits and emotional harm.

In short, the allegations in Krusinski mirror those in the

present case in many important respects.

The lower court in Krusinski granted the defendant

inspectors qualified immunity and the plaintiff appealed.

The Sixth Circuit held that the plaintiff had set forth

sufficient allegations that the individually named defen-

dants engaged in acts outside the scope of their respective

duties and in violation of the plaintiff’s constitutional rights.

Therefore, the court reversed the grant of immunity and

* Though Krusinski is an unpublished opinion, the Sixth Circuit

Rules of Practice allow unpublished cases to be cited for their preceden-

tial value in relation to a material issue. See Sixth Circuit Fed.R.App.P.

28(g).

remanded the case for further Bivens proceedings against

the individual USDA inspectors.

In addition to the Sixth Circuit, other circuit courts

have allowed Bivens claims against USDA employees

albeit in different contexts from that presented here. For

instance, in Love v. U.S., 915 F.2d 1242 (9th Cir. 1989), the

Ninth Circuit Court of Appeals allowed plaintiffs to main-

tain a Bivens action against individual employees of the

USDA Farmers Home Administration. There, the Ninth

Circuit stated that the plaintiffs’ “claim that the individual

defendants deprived them of property without due process

of law stated a valid claim for damages under the Consti-

tution.” Love, 915 F.2d at 1249 citing, Carlson v. Green,

446 U.S. 14, 18-19 (1980); other citations omitted. There-

fore, “the [plaintiffs] are entitled to plead the Bivens claim

along with the [Federal Tort Claims Act] claim as an

alternative basis for recovery.” Love, 915 F.2d at 1249.

Following the rule announced in Love, and presenting

another compelling reason for this Court to decide this

issue, a meat processing company filed a Bivens action in

the United States District Court for the Northern District

of California against individual USDA FSIS meat inspec-

tors. Veal Connection Corp. v. Thompson, Docket C 96-

04486 CW, Pet. App. 89a-145a. There, the district court

denied the inspectors’ motion to dismiss the Bivens claim

based upon qualified immunity. The case proceeded to trial

at which the inspectors were found liable of violating the

meat processor’s constitutional rights. Subsequently, the

trial judge ordered a new trial on the issue of damages.

The case settled in March 2005 before the damages trial

occurred.

The need for clarification of the availability of a

Bivens action is also evidenced in statements made by the

USDA itself. In May, 2004, the USDA issued a statement

of policy which created a new C.F.‘R. provision allowing for

indemnification of its employees for the legal consequences

of their conduct. Pet. App. 146a-152a. In its statement,

found at Fed.Reg. 28041, vol. 69, no. 96, May 18, 2004 and

reproduced at Pet. App. 146a-152a, the USDA noted that

“(lawsuits against Federal employees in their personal

capacities have proliferated since the Supreme Courts [sic]

decision in Bivens. ...” Pet. App. 147a. It went on to note

that “fa] number of [Bivens] actions have been filed

against USDA employees.” Pet. App. 147a. Accordingly, it

chose to provide indemnification based upon certain

parameters. See Pet. App. 148a, 7 C.F.R. § 1.1501.

The adoption of the indemnification provision clearly

demonstrates that the USDA believed Bivens suits were

commonplace enough to warrant the statement of policy

providing indemnification. The statement also demon-

strates the need for this Court to provide clear guidance as

to whether a Bivens suit is even available to potential

plaintiffs when they believe a USDA employee is violating

a constitutional right. Without doubt there is enough

uncertainty as to whether a Bivens remedy exists for suits

against USDA employees that neither district courts,

circuit courts, nor even the agency itself can form a con-

sensus.

B. Existence of a Bivens remedy against USDA

employees.

The presentment of a Bivens claim presents a federal

question. See Butz v. Economou, 438 U.S. 478, 504 (1978).

In reaching the issue of whether a Bivens remedy is

available to petitioner in this context, the Eighth Circuit

departed from other circuit courts to hold that USDA

employees cannot be liable under a Bivens theory. Unlike

other jurisdictions that recognized an action, the Eighth

Circuit focused its short analysis of the issue on three

principal findings which it concluded “counseled against

extending a Bivens remedy.” Pet. App. 7a. First, that

Congress “has not explicitly created any direct right of

action against USDA employees alleged to have committed

constitutional violations.” Pet. App. 7a. Second, that the

USDA has promulgated “a comprehensive regulatory

scheme pursuant to the FMIA that includes the right to

judicial review under the APA.” Pet. App. 7a-8a. Finally,

that Congress has created “a stringent exhaustion re-

quirement for grievances filed against USDA employees.”

Pet. App. 8a.

That Congress has not affirmatively created a direct

right of action is not dispositive of the issue. Bivens itself

was premised on the notion that without creating a rem-

edy directly under the Constitution some violations do not

have any remedy at law. If there were such a remedy,

creating a Bivens remedy would be unnecessary.

Likewise, the “comprehensive regulatory scheme”

referenced by the court is a misnomer. It is critical to note

that the present action is not simply a case of a regulated

entity being heard to complain that the regulator is

making mistakes in its regulation. Were that the case,

such complaints could, and should, be addressed to the

administrative procedures in place and referenced by the

Eighth Circuit. However, the complaint here is that the

individual inspectors would not only intentionally, know-

ingly and recklessly write non-compliance reports (““NRs”)

but that they took other actions to inhibit petitioner’s

constitutional rights to Due Process, Free Speech and to

petition for Redress of Grievances. There simply is no

“comprehensive regulatory scheme” in place to remedy

these complaints. Many of the actions complained of by

petitioner were evidenced by the individual NRs while

others had nothing to do with the writing of the NR at all,

and thus, could not even be brought before the administra-

tion in anything other than an informal complaint.

Furthermore, 7 C.F.R. § 1.130 et seg. (2005) provides

no relief to petitioner or other regulated entities. The plain

language of section 1.133(b)(1) cited by the court states

“lilf there is reason to believe that a person has violated or

is violating any provision of [inter alia, the FMIA) or of any

regulation, standard, instruction or order issued pursuant

thereto ... a complaint may be filed with the Hearing

Clerk.... ” 7 C.F.R. § 1.133(b)(1) (emphasis added); see

also, Pet. App. 73a n.4. Contrary to the holding of the

Eighth Circuit, petitioner has no basis for filing a com-

plaint based upon its belief that “a person” has violated its

constitutional rights. Again, the Eighth Circuit narrowly,

and erroneously, interpreted the complaint filed herein as

challenging only the issuance of several NRs. It completely

ignored the fact that petitioner’s complaint more broadly

alleged that the NRs were independent evidence of the

individual animus toward petitioner and the desire for

self-promotion and benefit on the part of the respondents.

Finally, the issue of the applicability of 7 U.S.C.

§ 6912(e) was addressed by the district court in response

to a different theory of dismissal advanced by respondents

— exhaustion of administrative remedies. To the extent the

issue of exhaustion was decided by the Eighth Circuit, it

was without the jurisdiction to do so on interlocutory

appeal. Indeed, the respondents did not even advance such

an argument to the Eighth Circuit. Nonetheless, even if

the Eighth Circuit relies upon that statutory section as

grounds for precluding a Bivens remedy doing so ignores

the exceptions to statutory exhaustion requirements and

departs from other jurisdictions which have not precluded

a Bivens action against USDA employees despite the

existence of section 6912(e). See generally, Krusinski uv.

USDA, 4 F.3d 994 (Table), 1993 WL 346858 (6th Cir. 1993)

(unpublished), Pet. App. 78a-88a; Love v. U.S., 915 F.2d

1242 (9th Cir. 1989); Sheehy v. Wehlage, 2004 WL 951367

(W.D.N.Y. Feb. 3, 2004) (plaintiff dairy farmers allowed to

bring Bivens case against USDA employees); Veal Connec-

tion Corp. v. Thompson, Docket C 96-04486 CW, Pet. App.

89a-145a. Furthermore, other jurisdictions have expressly

held that exhaustion under 6912(e) may not be required in

all instances. See McBride Cotton and Cattle Corp. v.

Veneman, 290 F.3d 973, 976 (9th Cir. 2002) (holding that

the exhaustion requirement of 6912(e) is not jurisdictional

and that exhaustion is excused because the plaintiff’s

complaint alleges collateral, colorable constitutional

claims and attempting to exhaust those claims would be

futile.)

Indeed, numerous cases have held that where a Bivens

plaintiff seeks only money damages which are not available

through the administrative process, exhaustion is not

required despite its statutory mandate. For example, in

Garrett v. Hawk, 127 F.3d 1263 (10th Cir. 1997), the Tenth

Circuit held that a prisoner seeking only money damages

against individual prison personnel under Bivens was not

required to exhaust his administrative remedies despite a

statutory mandate set forth in the Prison Litigation

Reform Act (“PLRA”). In Garrett, the government conceded

that a claim for money damages brought administratively

would be rejected as constituting improper subject matter

jurisdiction for administrative review and the inmate

would be referred to the Federal Tort Claims Act (“FTCA”).

Garrett, 127 F.3d at 1266.

The Tenth Circuit held that “while FTCA allows

claims against the government, a prisoner may not assert

personal liability against a prison official for violations of

the prisoner’s constitutional rights under FTCA.” Garrett

at 1266, see also, Carlson v. Green, 446 U.S. 14, 64 L.Ed.2d

15, 100 S.Ct. 1468 (1980) (Congress did not intend to pre-

empt a Bivens remedy when it enacted the FTCA). There-

fore, “until an administrative remedy is provided for

Bivens claims for money damages, we must conclude that.

no exhaustion of administrative remedies is required ...

because no such remedies exist to be exhausted.” Garrett

at 1267; see also, Rumbles v. Hill, 182 F.3d 1064 (9th Cir.

1999); Lunsford v. Jumao-As, 155 F.3d 1178 (9th Cir.

1998); Jackson v. DeTella, 998 F.Supp. 901, (N.D. Ml.

1998); Lacey v. C.S.P. Solano Medical Staff, 990 F.Supp.

1199 (E.D.Cal. 1997). As in Garrett, here there is simply no

administrative remedy under the FMIA or the applicable

sections of the Code of Federal Regulations available to

petitioner for the award of money damages resulting from

constitutional violations which caused calculable damage

to petitioner.

Similar to the prisoner cases cited above, the court in

Judicial Watch, Inc. v. Rossoiti, 217 F.Supp.2d 618 (D.Md.

2002), held that a Bivens action could be maintained

against individual officials of the Internal Revenue Service

(“IRS”) despite the existence of an administrative appeals

process. The court distinguished cases in which the harm

caused by the alleged constitutional violations amounted

to the illegal assessment or collection of taxes which could

be cured by refund suits and other similar statutory

remedies, and thus, were not appropriate for Bivens relief.

Judicial Watch, 217 F.Supp.2d at 625. Conversely, “where

the constitutional violation is a harm in itself, such as the

suppression of political speech or the violation of Fourth

Amendment rights, courts have recognized the propriety of

a Bivens remedy.” Id. citing, Nat'l Commodity and Barter

Assoc. v. Gibbs, 886 F.2d 1240, 1248 (10th Cir. 1989)

(permitting Bivens action for violations of the First and

Fourth Amendments because “certain values ... may be

superior to the need to protect the integrity of the internal

revenue system”); Western Center for Journalism v. Ceder-

quist, 235 F.3d 1153 (9th Cir. 2000) (Reinhardt, J., concur-

ring) (observing that a Bivens remedy is appropriate for

retaliatory audits because Congress has fashioned no

remedy for IRS conduct that punishes political speech);

Hurt v. United States, 889 F.Supp. 248 (S.D.W.Va. 1995)

(stating “[pllaintiffs allege a pattern of retaliatory and

harassing auditing and crediting practices used by the IRS

against them. This is sufficient to withstand a motion to

dismiss the Bivens claim.”).

Ultimately, the Judicial Waich court stated that a

“Bivens action should be available where, as here, the

statutory remedies provided in the Internal Revenue Code

... would not address the alleged constitutional wrongs of

the I.R.S. defendants.” Judicial Watch, 217 F.Supp.2d at

625. Again, under the administrative scheme available to

petitioner, there exists no remedy for constitutional

violations. Therefore, petitioner is not required to exhaust

any administrative remedies. See Garrett at 1267.

CONCLUSION

For the foregoing reasons the petition for writ should

be granted and petitioner respectfully asks this Honorable

Court to issue a writ of certiorari to the United States

Court of Appeals for the Eighth Circuit.

Respectfully submitted,

WILLIAM M. LAMSON, JR.*

BRIAN J. BRISLEN

ANASTASIA WAGNER

LAMSON, DUGAN AND Murray, LLP

10306 Regency Parkway Drive

Omaha, NE 68114

t: (402) 397-7300

f: (402) 397-7824

*Counsel of Record

Counsel for Nebraska Beef,

Limited, Petitioner

United States Court of Appeals

FOR THE EIGHTH CIRCUIT

No. 04-1918

Nebraska Beef, Ltd.,

Plaintiff/Appellee,

Vv.

Dennis Greening; Donald [sic]

Seitz; Chander Dev; Duane

Shonka; Michael Fast,

Defendants/Appellants,

John Doe, 1, Other FSIS

Appeal from the

United States District

Court for the District

of Nebraska.

Employees; Jane Doe, 1,

Other FSIS Employees;

John Doe, 2, Other FSIS

Employees; Jane Doe, 2,

Other FSIS Employees,

x 2. 2 © 2% © 2 + 2 + | © & & &

Defendants.

Submitted: December 16, 2004

Filed: February 28, 2005

Before WOLLMAN, MAGILL, and COLLOTON, Circuit

Judges.

WOLLMAN, Circuit Judge.

Nebraska Beef, Ltd., brought a Bivens’ suit against

federal food safety inspectors (Inspectors) from the United

States Department of Agriculture (USDA) based on actions

taken by the Inspectors pursuant to the Federal Meat

Inspection Act (FMIA), 21 U.S.C. § 601 et. seg. The Inspec-

tors appeal from the district court’s denial of their motion

to dismiss on the basis of qualified immunity. Because a

Bivens remedy is not available to Nebraska Beef, we

reverse.

Pursuant to the FMIA, the USDA has promulgated a

comprehensive regulatory scheme governing meat packing

and processing. See 9 C.F.R. pt. 417. Nebraska Beef

operates a packing and processing plant subject to inspec-

tion under the FMIA and its implementing regulations. On

September 3, 2002, the Inspectors conducted a public

health assessment of Nebraska Beef’s plant and issued

Noncompliance Records (NRs) for perceived regulatory

violations. Following several procedural actions, Nebraska

Beef and the USDA entered into a mutual consent decision

to resolve the NRs. According to Nebraska Beef, the

Inspectors maliciously issued fifty-eight additional NRs in

contravention of the consent decision.

Nebraska Beef initiated a Bivens action against the

Inspectors for damages to its reputation and business. The

Inspectors filed a motion to dismiss on several grounds

* Bivens v. Six Unknown Named Agents of Fed. Bureau of Narcot-

ics, 403 U.S. 388 (1971). Bivens allows tort actions against federal

officials and employees directly under the Constitution. See Estate of

Rosenberg by Rosenberg v. Crandell, 56 F.3d 35, 36 (8th Cir. 1995).

including qualified immunity and the nonavailability to

Nebraska Beef of a Bivens remedy. It is from the denial of

that motion that the Inspectors filed this interlocutory

appeal.

IT.

Nebraska Beef asserts that we lack jurisdiction to

consider the availability of a Bivens remedy. The Supreme

Court first recognized jurisdiction over an interlocutory

appeal from a denial of qualified immunity in Mitchell v.

Forsyth, 472 U.S. 511 (1985). In Drake v. Scott, we held

that this jurisdiction encompassed the related issue of

whether a complaint failed to state a claim, holding that

when an interlocutory appeal of a denial of qualified

immunity is properly before us, we may decide “closely

related issues of law.” 812 F.2d 395, 399 (8th Cir. 1987),

aff’d on reh’g, 823 F.2d 239 (8th Cir. 1987). The defen-

dants in Drake had asserted qualified immunity but had

also argued that Drake’s due-process claim failed as a

matter of law because Drake had no property interest. Jd.

at 398. We noted that “[ijf Drake possesses no property

interest, he cannot succeed on his claim, and we need not

reach the immunity issue.” Jd. at 399. We observed that

the property-interest question was “analytically antece-

dent to, and in a sense also pendent to, the qualified-

immunity issue.” Jd.

Subsequent to Drake, the Supreme Court considered a

Bivens claim that alleged an infringement of Fifth

Amendment due-process “liberty interests” in Siegert uv.

Gilley, 500 U.S. 226, 229 (1991). The Supreme Court

instructed that:

A necessary concomitant to the determination of

whether the constitutional right asserted by a

plaintiff is ‘clearly established’ at the time the de- —~

fendant acted is the determination of whether

the plaintiff has asserted a violation of a consti-

tutional right at all. Decision of this purely legal

question permits courts expeditiously to weed out

suits which fail the test without requiring a de-

fendant who rightly claims qualified immunity to

engage in expensive and time consuming prepa-

ration to defend the suit on its merits. One of the

purposes of immunity, absolute or qualified, is to

spare a defendant not only unwarranted liability,

but unwarranted demands customarily imposed

upon those defending a long drawn out lawsuit.

Id. at 232.

The Supreme Court revisited the jurisdictional limits

of an interlocutory appeal from a denial of qualified

immunity in Johnson v. Jones, 515 U.S. 304 (1995). The

Court examined whether appellate courts had jurisdiction

to consider pretrial “evidence insufficiency” claims in an

interlocutory appeal from the denial of qualified immunity.

Id. at 308. The Court stressed that the issue on appeal

concerned “a fact-related dispute” as to whether the

pretrial record contained evidence sufficient to show a

genuine issue of fact for trial. Jd. at 307 (original empha-

sis). The Court cautioned against expansive jurisdiction,

observing that an interlocutory appeal “can threaten

[district court] proceedings with delay, adding costs and

diminishing coherence” and that such an appeal “risks

additional, and unnecessary, appellate court work either

when it presents appellate courts with less developed records

or when it brings them appeals that, had the trial simply

proceeded, would have turned out to be unnecessary.” Id.

at 309. The Court concluded that a question involving only

evidence sufficiency, i.e., which facts a party may be able

to prove at trial, is not appealable. Jd. at 313.

The following year, in Behrens v. Pelletier, the Court

restated its holding in Johnson, observing that: “summary

judgment determinations are appealable when they

resolve a dispute concerning an abstract issue of law

relating to qualified immunity — typically, the issue

whether the federal right allegedly infringed was ‘clearly’

established.” 516 U.S. 299, 313 (1996) (internal citations

and quotations omitted) (original emphasis).

The question before us, then, is whether, in light of

Siegert, Johnson, and Behrens, the availability of a Bivens

remedy is an issue of law that is “closely related” to or

“inextricably intertwined” with the denial of qualified

immunity.’ Although the lack of a Bivens remedy would

not entitle the defendants to qualified immunity,’ the issue

is “analytically antecedent to, and in a sense also pendent

to, the qualified immunity issue.” Drake, 812 F.2d at 399.

It is a purely legal question that presents none of the

* In Kincade v. City of Blue Springs, Mo., 64 F.3d 389, 394-95 (8th

Cir. 1995), we equated our “closely related” definition to the “inextrica-

bly intertwined” language used in Swint v. Chambers County Comm'n,

514 U.S. 35 (1995). Cf. Prescott v. Little Six, Inc., 387 F.3d 753, 756 n. 2

(8th Cir. 2004).

* We note that dictum in Buchholz v. Aldaya 210 F.3d 862 (8th Cir.

2000) suggests otherwise. We stated in Buchholz, citing Drake, that “[i]f

defendants prevail on [establishing that Buchholz has no cause of

action], ‘it follows a fortiori’ they are entitled to qualified immunity.” Jd.

at 865. This assertion, which had no effect on the holding in Buchholz,

does not inexorably flow from our holding in Drake. Concluding that a

Bivens action is unavailable precludes the need to decide whether the

defendants are entitled to qualified immunity; it does not entitle them

to qualified immunity.

judicial economy concerns addressed in Johnson. In fact,

common sense tells us that addressing this potentially

dispositive legal question serves the interests of judicial

economy. If we remanded to the district court and the

plaintiffs prevailed at trial, we would likely see the same

appeal again, after the cost and time of litigating a lawsuit

which, if no Bivens remedy exists, is doomed from its

inception. Accordingly, we conclude that we have jurisdic-

tion to consider the availability of a Bivens remedy. See

Moreno v. Small Bus. Admin., 877 F.2d 715, 716 (8th Cir.

1989) (question of qualified immunity on interlocutory

appeal is moot when Bivens action is precluded by com-

prehensive regulatory scheme); see also Hill v. Dep’t of the

Air Force, 884 F.2d 1318, 1320 (10th Cir. 1989) (deciding

interlocutory appeal based on lack of Bivens remedy and

not reaching issue of qualified immunity); cf. Merritt v.

Shuttle, Inc., 187 F.3d 263, 268-69 (2d Cir. 1999) (resolving

predicate issue of subject matter jurisdiction is “necessary

to ensure meaningful review of” denial of qualified im-

munity). But see Triad Assocs., Inc. v. Robinson, 10 F.3d

492, 496-97 n. 2 (7th Cir. 1993) (refusing to extend pen-

dent jurisdiction to “collateral” legal issues of standing

unrelated to qualified immunity and finding no “‘compel-

ling reasons’ for not deferring the limitations questions

until the end of the lawsuit”); Kwai Fun Wong v. United

States, 373 F.3d 952, 961 (9th Cir. 2004) (stating that

resolving the availability of a Bivens remedy “is not a

logical predicate to tne resolution of ... the qualified

immunity issue”).

II.

The Supreme Court has been wary of extending

Bivens remedies into new contexts, Schwetker v. Chilicky,

487 U.S. 412, 421 (1988), and has not created additional

Bivens remedies “[w]hen the design of a Government

program suggests that Congress has provided what it

considers adequate remedial mechanisms for constitu-

tional violations that may occur in the course of its ad-

ministration.” Id. at 423. We have noted that this is the

case even when the administrative remedy does not

provide complete relief. Sinclair v. Hawke, 314 F.3d 934,

940 (8th Cir. 2003).

There is a “presumption against judicial recognition of

direct actions for violations of the Constitution by federal

officials or employees,” and “[ilf Congress has not explicitly

created such a right of action, and if it has created other

remedies to vindicate (though less completely) the particu-

lar rights being asserted in a given case, the chances are

that the courts will leave the parties to the remedies

Congress has expressly created for them.” McIntosh v.

Turner, 861 F.2d 524, 526 (8th Cir. 1988). When Congress

has created a comprehensive regulatory regime, the

existence of a right to judicial review under the APA is

sufficient to preclude a Bivens action. Sinclair, 314 F.3d at

940. Parties may not avoid administrative review simply

by fashioning their attack on an agency decision as a

constitutional tort claim against individual agency officers.

Id.

Three factors counsel against extending a Bivens

remedy to an action brought against the Inspectors. First,

Congress has not explicitly created any direct mght of

action against USDA employees alleged to have committed

constitutional violations. Second, the USDA has promul-

gated a comprehensive regulatory scheme pursuant to the

FMIA that includes the right to judicial review under the

APA.’ Finally, Congress has created a stringent exhaustion

requirement for grievances filed against USDA employees,

see 7 U.S.C. § 6912(e), which further evidences its intent to

have grievances aired to and addressed by the agency

prior to our review.

Given the above factors, as well as the Supreme

Court’s caution against extending Bivens remedies to new

contexts, we conclude that such a remedy is not available

to Nebraska Beef. Cf. Sinclair, 314 F.3d at 942-43 (observ-

ing that personal liability for bank regulators in the

“complex regulatory environment” of the banking industry

is for Congress to decide). Because we resolve the instant

case on the lack of a Bivens remedy, we do not reach the

issue of qualified immunity. We reverse the district court’s

denial of the Inspector’s motion to dismiss and remand

with an order to dismiss the complaint for failure to state

a claim upon which relief can be granted.

* These procedures include provisions for an administrative appeal

from an adverse decision by a USDA inspector. See 9 C.F.R. §§ 500.2(c)

and 500.5 (2005). The Secretary of Agriculture has also promulgated

“Uniform Rules of Practice” which establish procedures for making an

appeal to the agency. See 7 C.F.R. § 1.130 ef. seg. (2005). Under those

regulations, an aggrieved party may file a complaint if there “is reason

to believe that a person has violated or is violating any provision of

[inter alia, the FMIA] or of any regulation, standard, instruction or

order issued pursuant thereto.” Jd. at § 1.133(b)(1). A final order by the

USDA's Judicial Officer is subject to judicial review. Id. at § 1.145(i).

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEBRASKA

NEBRASKA BEEF, LTD., 8:03CV175

Plaintiff,

Vv.

DENNIS GREENING,

RONALD SEITZ, CHANDER MEMORANDUM

DEV, DUANE SHONKA, AND ORDER

MICHAEL FAST, OTHER

FSIS EMPLOYEES, JOHN

DOE 1, JOHN DOE 2, JANE

DOE 1, and JANE DOE 2,

Defendants.

Introduction

This matter is before the court on defendants’ motion

to dismiss, Filing No. 16, pursuant to Fed. R. Civ. P.

12(b)(1) and (6). Plaintiff brings this action alleging that

defendants, in their individual capacities, have engaged in

unfair, arbitrary, and capricious conduct against it in

violation of the United States Constitution. Plaintiff

alleges that defendants violated its due process rights and

acted in contravention of its statutory authority. Defen-

dants argue that this court is without jurisdiction to

decide these claims, contending that plaintiff lacks stand-

ing, has failed to exhaust administrative remedies, and

has failed to adequately plead both the Bivens action and

the conspiracy claim. Defendants further allege they have

qualified immunity from suit. I have carefully reviewed

the record, indices of evidence, briefs in support and in

opposition, and the relevant case and administrative law,

and I conclude the motion to dismiss should be denied at

10a

this time. I have entered an order concurrently with this

Order in the related case of United States v. USDA,

03CV174 (D.Neb. March 18, 2004) (Memorandum and

Order on motion to dismiss). The facts, procedural history

and the issues of standing, exhaustion and due process are

identical in most respects. To that extent, I have included

the same analysis in both opinions. To the extent that

claims overlap, my findings will be applicable in both

cases.

Facts/Procedural History

On January 14, 2003, plaintiff filed a complaint in

this court asking for a temporary restraining order against

the United States Department of Agriculture (USDA), as

the USDA was considering suspending its inspection

services at plaintiff’s beef processing plant. Nebraska Beef

v. USDA, 03CV16 (D.Neb.2003). A temporary restraining

order (TRO) was granted. /d., Filing No. 2. Prior to the

hearing on the preliminary injunction, the Food Safety

and Inspection Service (FSIS) filed an administrative

complaint against the plaintiff with an administrative law

judge (ALJ) with the USDA. The parties thereafter mutu-

ally agreed to enter into a Consent Decision and Order and

to dismiss the case before me with prejudice and for

termination of the TRO. The Consent Decision and Order

required plaintiff to comply with statutory law and federal

regulations and required withdrawal of the inspectors to

be held in abeyance.

Subsequent to the Consent Decision, plaintiff has filed

two lawsuits in this court. The one before me in this

lawsuit is against various officials who work for the

USDA; the second lawsuit has been filed against the

lla

USDA. Nebraska Beef v. USDA, 03CV174 (D.Neb. May 2,

2003). Plaintiff alleges that-since the Consent Decision,

inspection personnel issued fifty-eight noncompliance

reports (NRs). These reports have been issued over a

three-month period of time. Plaintiff contends that these

NRs were improperly issued, unfair and biased, and in

violation of the law. Plaintiff cites numerous instances

where it believes the defendants improperly issued these

NRs. Further, plaintiff alleges that not once has there

been a food safety issue present. The defendants allege

qualified immunity; lack of exhaustion; lack of standing;

and lack of a due process violation. In the related case,

Nebraska Beef v. USDA, 03CV174, the same standing,

ripeness, due process and exhaustion claims are raised,

and plaintiff also alleges a breach of contract claim. To the

extent that claims overlap, my findings will be applicable

to both cases.

Standard of Review

12(6)(1)

Because jurisdiction is a threshold issue for the court,

the district court has broader power to decide its own right

to hear the case than it has when the merits of the case

are reached. Bellecourt v. United States, 994 F.2d 427, 430

(8th Cir.1993). For the court to dismiss for lack of subject

matter jurisdiction under Federal Rule of Civil Procedure

12(b)(1), the complaint must be successfully challenged

either on its face or on the factual truthfulness of its

averments. Titus v. Sullivan, 4 F.3d 590, 593 (8th

Cir.1993). In a facial challenge to jurisdiction, all of the

factual allegations regarding jurisdiction would be pre-

sumed true and the motion could succeed only if the

plaintiff had failed to allege an element necessary for

12a

subject matter jurisdiction. Jd. In a factual attack on the

jurisdictional allegations of the complaint, however, the

court can consider competent evidence such as affidavits,

deposition testimony, and the like in order to determine

the factual dispute. ‘d. Because the parties have submit-

ted some evidence in support of their respective positions,

this case presents a factual jurisdictional challenge. In

such a challenge, this court is “free to weigh the evidence

and satisfy itself as to the existence of its power to hear

the case.” Osborn v. United States, 918 F.2d 724, 729 (8th

Cir. 1990). No presumptive truthfulness attaches to the

plaintiff’s allegations, and the existence of disputed

material facts will not preclude the court from evaluating

for itself the merits of jurisdictional claims. Jd. The plain-

tiff has the burden of proving that jurisdiction does in fact

exist. Id. at 730.

12(6)(6)

In considering a motion to dismiss a complaint under

Rule 12(b)(6), the court must assume all the facts alleged

in the complaint are true, and must liberally construe the

complaint in the light most favorable to the plaintiff.

Schmeddir.« v. Tnemec Co., 187 F.3d 862, 864 (8th Cir.

1999). A Kule 12(bX6) motion to dismiss a complaint

should not be granted unless it appears beyond a doubt

that the pleintiff can prove no set of facts which would

entitle him to relief. Jd. Thus, as a practical matter, a

dismissal under Rule 12(b)(6) should be granted only in

the unusual case in which a plaintiff includes allegations

that show on the face of the complaint that there is some

insuperable bar to relief. Jd.

Discussion

A. Exhaustion

A plaintiff must exhaust administrative remedies in

order for a court to have subject matter jurisdiction.

United States v. Dico, Inc., 136 F.3d 572, 575 (8th Cir.

1998); 7 U.S.C. §6912(e). Generally, failure to exhaust

administrative remedies will preclude one from seeking

relief in federal court. See Weinberger v. Salfi, 422 U.S.

749, 764 (1975). Exhaustion is required in order to prevent

premature interference with agency processes, to permit

the agency to function efficiently and so that it may have

an opportunity to correct its own errors, to afford the

parties and the courts the benefit of its experience and

expertise, and to compile a record which is adequate for

judicial review. In Home Health, Inc. v. Shalala, 272 F.3d

554, 559-60 (8th Cir. 2001); United States v. Dico, Inc., 136

F.3d at 576. The relevant statute in this case requires

exhaustion of all administrative appeal procedures before

one can sue the Secretary of Agriculture or officers or

employees. 7 U.S.C. § 6912(e). Defendants contend that

fifty-three of the fifty-eight NRs are being administra-

tively appealed, and at least one has been found to be in

the plaintiff’s favor. The USDA argues that such failure to

exhaust all claims requires dismissal of the lawsuit at this

time.

Plaintiff argues that there are three exceptions to a

statutory exhaustion requirement. Calhoun v. USDA, 920

F. Supp. 696, 700 (N.D.Miss. 1996). These exceptions

include: (1) raising a constitutional challenge collateral to

the substantive claim, see Bowen v. City of New York, 476

U.S. 467, 483 (1986); (2) alleging that the administrative

system itself is unlawful; and (3) inadequacy of the admin-

istrative remedies, see DCP Farms v. Yeutter, 957 F.2d

l4a

1183 (5th Cir. 1992) (discussion of exceptions two and

three). With regard to the first exception, plaintiff asserts

that exhaustion is not required where a party poses a

constitutional challenge to the administrative procedure.

Bowen, 476 U.S. at 483; In Home Health, 272 F.3d at 559-

60. In the case before me, plaintiff argues that defendants

have violated its due process rights. With regard to the

second exception, plaintiff argues that the USDA is acting

outside the power it has received by Congress by the

Federal Meat Inspection Act (FMIA), 21 U.S.C. § 601.

Plaintiff contends that the Hazardous Analysis and

Critical Control Point (HACCP) and the Sanitation Stan-

dard Operating Procedures (SSOP) are in violation of the

statutory authority granted to the USDA by Congress.

Plaintiff challenges the administrative process as uncon-

stitutional.

It is true that plaintiff has commenced, but has not

completed, administrative appeals in this case. If plaintiff

were merely complaining about whether these violations

should have been written, I would agree with defendants

that the exhaustion doctrine applies. The scheme set forth

by Congress clearly requires exhaustion of such disagree-

ments. However, plaintiff’s complaint, unequivocally

alleges constitutional claims of due process violations,

retaliation, conspiracy between and among the defen-

dants, equal protection and free speech violations, as well

as arbitrary and capricious behavior on the part of defen-

dants. These claims do not need to be exhausted and are

subject to court intervention. Consequently, I conclude

that while plaintiff should continue to exhaust its admin-

istrative remedies on the merits of the administrative

claims, these claims that involve the constitution and

15a

statutory authority of the defendants do not require

exhaustion.

B. Standing

The burden is on plaintiff to show that it has standing

to sue. Lugan v. Defenders of Wildlife, 504 U.S. 737, 750

(1984). To establish standing, plaintiff has the burden of

showing that it has sustained or will sustain immediate

damage or injury. City of Los Angeles v. Lyons, 461 U.S. 95,

101-02 (1983). Damage to reputation can be sufficient to

confer standing on a party. Southern Mutual Help Ass’n,

Inc. v. Califano, 574 F.2d 518, 524 (D.C.Cir. 1977). Defen-

dants argue that plaintiff has no standing to bring this

action. Defendants argue that there is no injury in fact,

because the appeal process has not yet been completed.

Plaintiff argues that it has standing because the defen-

dants have violated its due process rights, have exceeded

statutory authority by creating the requirement that

plaintiff maintain HACCP and SSOP plans, and has

issued fifty-eight NRs that are published to anyone obtain-

ing information through the Freedom of Information Act.

Plaintiff further argues that when the NRs become public

records, it hurts plaintiff’s reputation and business. I

agree. I have already determined that plaintiff can bring

the causes of action concerning the statutory and constitu-

tional claims. Plaintiff has alleged sufficient injury so as to

have standing in this case.

C. Bivens Claim

Plaintiff has brought a Bivens claim alleging that

defendants have committed constitutional torts against it.

Bivens v. Six Unknown Named Agents of Federal Bureau

16a

of Narcotics, 403 U.S. 388 (1971). Bivens allows for a cause

of action for damages against federal officials who violate

a person’s constitutional rights. Jd. 397. Bivens actions

have not been allowed where Congress has provided

adequate remedial measures. Schweiker v. Chilicky, 487

U.S. 412, 423 (1988). However, Bivens is “a powerful tool

against such governmental abuse, and must be available

in appropriate cases.” Western Center for Journalism v.

Cederquist, 235 F.3d 1153, 1159 (9th Cir. 2000) (concurring

opinion). Defendants contend that there is an adequate

remedy through the administrative scheme which is

comprehensive, allows for numerous appeals and is

designed to address issues such as those complained of by

the plaintiff. See 7 U.S.C. § 6912(e).

Further, argue defendants, there is no cognizable

constitutional tort against them. The plaintiff must plead

the personal involvement of each defendant and not rely

only on the supervisory roles of any of the defendants.

Buford v. Runyon, 160 F.3d 1199, 1203 n. 7 (8th Cir. 1999).

Defendants also argue that plaintiff has not alleged a

sufficient property interest to allow them to proceed with

the due process and equal protection claims. Issuance of

the NRs, argues defendants, did not deprive plaintiff of

any property interest, and again, plaintiff had adequate

remedial avenues it could pursue. See Zephyr Aviation v.

Dailey, 247 F.3d 565, 574 (5th Cir. 2001) (no procedural

due process violation where adequate post-deprivation

remedy exists). As for the speech and redress of grievance

claims, defendants contend that plaintiff alleges conclu-

sory claims that cannot withstand a motion to dismiss.

Plaintiff contends that there are no adequate reme-

dies in the administrative scheme to compensate it for the

damages incurred. There is no adequate remedy in the

17a

administrative scheme for a constitutional wrong, argues

plaintiff, particularly where there is abuse of power,

overreaching and oppression. With regard to the due

process and equal protection claims, plaintiff argues that

the retention of the beef carcasses is one example of

damage it sustained; that unconstitutional interference

has occurred because the Act gives certain powers to the

USDA which do not include HAACP and SSOP require-

ments yet can close down businesses; that the arbitrary

decisions of the defendants erect unfair barriers and

allows unequal treatment and prohibit unfair competition.

With regard to the speech and grievances deprivations,

plaintiff argues that it will prove a pattern of retaliation

on the part of the defendants that occurred because

plaintiff appealed the NRs, filed a lawsuit, and supported

certain officials who filed discrimination actions against

the USDA.

Plaintiff has a right to operate its business free from

unconstitutional interference. In a recent [sic], a Califor-

nia court heard a case wherein the plaintiff, a meat

packing plant and its owners, was subject to inspection by

the FSIS. Plaintiffs sued various USDA employees and

alleged that these federal officials retaliated against them

because of their complaints about the FSIS’s actions in

issuing unfair process deficiency reports and for withhold-

ing inspections. The Veal Connection Corp. v. Thompson,

CV96-4486 and CV02-4609 (N.D.Cal. February 3, 2004).

As noted in Veal Connection, taking legitimate enforce-

ment action with the intent to reinstate because a party

exercised its First Amendment Rights is not constitu-

tional. Veal Connection, No. 96-4486, p. 5. The burden is on

the defendants to show they would have acted in the same

manner in the absence of the protected conduct. Soranno’s

18a

Gasco Inc. v. Morgan, 874 F.2d 1310, 1314 (9th Cir. 1989).

I conclude that plaintiff’s complaint details sufficient

actions with dates and locations and names of defendants

known to have violated constitutional rights. Motives have

also been alleged, and even though defendants Greening,

Seitz, and Dev are supervisors, allegations beyond these

supervisory roles have been stated.

D. Qualified Immunity

Federal officials are immune from suit if their conduct

“does not violate clearly established statutory or constitu-

tional rights of which a reasonable person would have

known.” Harlow v. Fitzgerald, 457 U.S. 800, 818 (1982).

Qualified immunity protects officials from suit except

when they knowingly violate the constitution. Malley v.

Briggs, 475 U.S. 335 (1986). The defendants must have

violated a constitutional right, and that constitutional

right must have been clearly established. Ware v. Morri-

son, 276 F.3d 385, 387 (8th Cir.2002).

Defendants argue that there is no violation of a

clearly established constitutional right, and therefore,

they are entitled to qualified immunity from suit. Defen-

dants contend that they were just doing their job and that

their conduct in all instances was reasonable. Plaintiff

disagrees, arguing that the due process and equal protec-

tion violations were intentional on the part of the defen-

dants, therefore taking them out of the protection of

qualified immunity. Plaintiff argues that it had a known

constitutional right that is established by law and thus

defendants’ violation is not protected. Because I have

already concluded that plaintiff has stated constitutional

and statutory claims against the defendants herein, I

19a

likewise conclude that these claims are sufficient to take

the defendants out of the protection of qualified immunity.

Qualified immunity does not provide a shield for regula-

tery actions taken for an unlawful purpose. Veal Connec-

tion Corp., No. 96-4486, p. 5.

E. Conspiracy

Defendants argue that plaintiff must plead specific

facts to support this claim, as the allegations cannot be

conclusory in nature. Nelson v. City of McGehee, 876 F.2d

56, 59 (8th Cir. 1989). “[T]he complaint must contain facts

which state a claim as a matter of law and must not be

conclusory.” Frey v. City of Herculaneum, 44 F.3d 667 (8th

Cir. 1995). However, plaintiff need not show that it will

win at trial at this point in the lawsuit. Hafley v. Lohman,

90 F.3d 264, 267 (8th Cir. 1996). Plaintiff has pled suffi-

cient facts of retaliation, conspiracy, personal desire to

gain promotions and overtime, and arbitrary and capri-

cious enforcement of federal regulations, to meet its

burden in a motion to dismiss claim. See, The Veal Connec-

tion Corp, No. 96-4486, p. 6.

I urge the parties to continue to pursue the adminis-

trative processes available to them in this case with the

hope that settlement will occur. The USDA must act in

good faith and deal fairly with the plaintiff, and yet the

plaintiff must comply with the legal requirements applica-

ble to it.

THEREFORE, IT IS ORDERED that defendants’

motion to dismiss, Filing No. 16, is denied.

20a

DATED this 18th day of March, 2004.

BY THE COURT:

/s/ Joseph F. Bataillon

United States District Judge

2la

FEDERAL MEAT INSPECTION ACT

21 U.S.C. § 601. Definitions

As used in this chapter, except as otherwise specified,

the following terms shall have the meanings stated below:

(a) The term “Secretary” means the Secretary of

Agriculture of the United States or his delegate.

(b) The term “firm” means any partnership, associa-

tion, or other unincorporated business organization.

or corporation engaged in the business of buying or selling

carcasses, parts of carcasses, meat, or meat food products

of cattle, sheep, swine, goats, horses, mules, or other

equines on commission, or otherwise negotiating pur-

chases or sales of such articles other than for his own

account or as an employee of another person, firm, or

corporation.

(d) The term “renderer” means any person, firm, or

corporation engaged in the business of rendering carcasses or

parts or products of the carcasses, of cattle, sheep, swine,

goats, horses, mules, or other equines, excent rendering

conducted under inspection or exemption under ‘title I of this

Act [21 U.S.C.A. §§ 601 et seq.].

(e) The term “animal food manufacturer” means any

person, firm, or corporation engaged in the business of

manufacturing or processing animal food derived wholly or

in part from carcasses, or parts or products of the car-

casses, of cattle, sheep, swine, goats, horses, mules, or

other equines.

(f) The term “State” means any State of the United

States and the Commonwealth of Puerto Rico.

22a

(g) The term “Territory” means Guam, the Virgin

Islands of the United States, American Samoa, and any

other territory or possession of the United States, exclud-

ing the Canal Zone.

(h) The term “commerce” means commerce between

any State, any Territory, or the District of Columbia, and

any place outside thereof; or within any Territory not

organized with a legislative body, or the District of Colum-

bia.

(i) The term “United States” means the States, the

District of Columbia, and the Territories of the United

States.

(j) The term “meat food product” means any product

capable of use as human food which is made wholly or in

part from any meat or other portion of the carcass of any

cattle, sheep, swine, or goats, excepting products which

contain meat or other portions of such carcasses only in a

relatively small proportion or historically have not been

considered by consumers as products of the meat food

industry, and which are exempted from definition as a

meat food product by the Secretary under such conditions

as he may prescribe to assure that the meat or other

portions of such carcasses contained in such product are

not adulterated and that such products are not repre-

sented as meat food products. This term as applied to food

products of equines shall have a meaning comparable to

that provided in this paragraph with respect to cattle,

sheep, swine, and goats.

(k) The term “capable of use as human food” shall

apply to any carcass, or part or product of a carcass, of any

animal, unless it is denatured or otherwise identified as

required by regulations prescribed by the Secretary to

23a

deter its use as h man food, or it is naturally inedible by

humans.

(1) The term “prepared” means slaughtered, canned,

salted, rendered, boned, cut up, or otherwise manufac-

tured or processed.

(m) The term “adulterated” shall apply to any

carcass, part thereof, meat or meat food product under one

or more of the following circumstances:

(1) if it bears or contains any poisonous or deleteri-

ous substance which may render it injurious to health; but

in case the substance is not an added substance, such

article shall not be considered adulterated under this

clause if the quantity of such substance in or on such

article does not ordinarily render it injurious to health;

(2A) if it bears or contains (by reason of admini-

stration of any substance to the live animal or otherwise)

any added poisonous or added deleterious substance (other

than one which is (i) a pesticide chemical in or on a raw

agricultural commodity; (ii) a food additive; or (iii) a color

additive) which may, in the judgment of the Secretary,

make such article unfit for human food,

(B) if it is, in whole or in part, a raw agricultural

commodity and such commodity bears or contains a

pesticide chemical which is unsafe within the meaning of

section 346a of this title,

unsafe within the meaning of section 348 of this title,

(D) if it bears or contains any color additive which is

unsafe within the meaning of section 379e of this title:

Provided, That an article which is not adulterated under

24a

clause (B), (C), or (D) shall nevertheless be deemed adul-

terated if use of the pesticide chemical, food additive, or

color additive in or on such article is prohibited by regula-

tions of the Secretary in establishments at which inspec-

tion is maintained under this subchapter;

(3) if it consists in whole or in part of any filthy,

putrid, or decomposed substance or is for any other reason

unsound, unhealthful, unwholesome, or otherwise unfit for

human food;

(4) if it has been prepared, packed, or held under

insanitary conditions whereby it may have become con-

taminated with filth, or whereby it may have been ren-

dered injurious to health;

(5) if it is, in whole or in part, the product of an

animal which has died otherwise than by slaughter;

(6) if its container is composed, in whole or in part, of

any poisonous or deleterious substance which may render

the contents injurious to health;

(7) if it has been intentionally subjected to radiation,

unless the use of the radiation was in conformity with a

regulation or exemption in effect pursuant to section 348

of this title;

(8) if any valuable constituent has been in whole or

in part omitted or abstracted therefrom; or if any sub-

stance has been substituted, wholly or in part therefor; or

if damage or inferiority has been concealed in any manner;

or if any substance has been added thereto or mixed or

packed therewith so as to increase its bulk or weight, or

reduce its quality or strength, or make it appear better or

of greater value than it is; or

25a

(9) if it is margarine containing animal fat and any

of the raw material used therein consisted in whole or in

part of any filthy, putrid, or decomposed substance.

(n) The term “misbranded” shall apply to any car-

cass, part thereof, meat or meat food product under one or

more of the following circumstances:

(1) if its labeling is false or misleading in any par-

ticular;

(2) if it is offered for sale under the name of another

food;

(3) if it is an imitation of another food, unless its

label bears, in type of uniform size and prominence, the

word “imitation” and immediately thereafter, the name of

the food imitated;

(4) if its container is so made, formed, or filled as to

be misleading;

(5) if in e« package or other container unless it bears

a label showing (A) the name and place of business of the

‘manufacturer, packer, or distributor; and (B) an accurate

statement of the quantity of the contents in terms of

weight, measure, or numerical count: Provided, That

under clause (B) of this subparagraph (5), reasonable

variations may be permitted, and exemptions as to small

packages may be established, by regulations prescribed by

the Secretary;

(6) if any word, statement, or other information

required by or under authority of this chapter to appear on

the label or other labeling is not prominently placed thereon

with such conspicuousness (as compared with other words,

statements, designs, or devices, in the labeling) and in such

26a

terms as to render it likely to be read and understood by

the ordinary individual under customary conditions of

purchase and use;

(7) if it purports to be or is represented as a food for

which a definition and standard of identity or composition

has been prescribed by regulations of the Secretary under

section 607 of this title unless (A) it conforms to such

definition and standard, and (B) its label bears the name

of the food specified in the definition and standard and,

insofar as may be required by such regulations, the com-

mon names of optional ingredients (other than spices,

flavoring, and coloring) present in such food;

(8) if it purports to be or is represented as a food for

which a standard or standards of fill of container have

been prescribed by regulations of the Secretary under

section 607 of this title, and it falls below the standard of

fill of container applicable thereto, unless its label bears,

in such manner and form as such regulations specify, a

statement that it falls below such standard;

(9) if it is not subject to the provisions of subpara-

graph (7), unless its label bears (A) the common or usual

name of the food, if any there be, and (B) in case it is

fabricated from two or more ingredients, the common or

usual name of each such ingredient; except that spices,

flavorings, and colorings may, when authorized by the

Secretary, be designated as spices, flavorings, and color-

ings without naming each: Provided, That to the extent

that compliance with the requirements of clause (B) of this

subparagraph (9) is impracticable, or results in deception

or unfair competition, exemptions shall be established by

regulations promulgated by the Secretary;

27a

(10) If it purports to be or is represented for special

dietary uses, unless its label bears such information

concerning its vitamin, mineral, and other dietary proper-

ties as the Secretary, after consultation with the Secretary

of Health and Human Services, determines to be, and by

regulations prescribes as, necessary in order fully to

inform purchasers as to its value for such uses;

(11) If it bears or contains any artificial flavoring,

artificial coloring, or chemical preservative, unless it bears

labeling stating that fact: Provided, That, to the extent

that compliance with the requirements of this subpara-

graph (11) is impracticable, exemptions shall be estab-

lished by regulations promulgated by the Secretary; or

(12) If it fails to bear, directly thereon or on its

container, as the Secretary may by regulations prescribe,

the inspection legend and, unrestricted by any of the

foregoing, such other information as the Secretary may

require in such regulations to assure that it will not have

false or misleading labeling and that the public will be

informed of the manner of handling required to maintain

the article in a wholesome condition.

(o) The term “label” means a display of written,

printed, or graphic matter upon the immediate container

(not including package liners) of any article.

(p) The term “labeling” means all labels and other

written, printed, or graphic matter (1) upon any article or

any of its containers or wrappers, or (2) accompanying

such article.

(q) The term “Federal Food, Drug, and Cosmetic Act

[21 U.S.C.A. § 301 et seq.]” means the Act so entitled,

28a

approved June 25, 1938 (52 Stat. 1040) [21 U.S.C.A. § 301 et

seq.], and Acts amendatory thereof or supplementary thereto.

(r) The terms “pesticide chemical,” “food additive,”

“color additive,” and “raw agricultural commodity” shall

have the same meanings for purposes of this chapter as

under the Federal Food, Drug, and Cosmetic Act [21

U.S.C.A. § 301 et seq.].

(s) The term “official mark” means the official

inspection legend or any other symbol prescribed by

regulations of the Secretary to identify the status of any

article or animal under this chapter.

(t) The term “official inspection legend” means any

symbol prescribed by regulations of the Secretary showing

that an article was inspected and passed in accordance

with this chapter.

(u) The term “official certificate” means any certifi-

cate prescribed by regulations of the Secretary for issu-

ance by an inspector or other person performing official

functions under this chapter.

(v) The term “official device” means any device

prescribed or authorized by the Secretary for use in

applying any official mark.

21 U.S.C. § 602. Congressional statement of findings

Meat and meat food products are an important source

of the Nation’s total supply of food. They are consumed

throughout the Nation and the major portion thereof

moves in interstate or foreign commerce. It is essential in

the public interest that the health and welfare of consum-

ers be protected by assuring that meat and meat food

29a

products distributed to them are wholesome, not adulter-

ated, and properly marked, labeled, and packaged. Un-

wholesome, adulterated, or misbranded meat or meat food

products impair the effective regulation of meat and meat

food products in interstate or foreign commerce, are

injurious to the public welfare, destroy markets for whole-

some, not adulterated, and properly labeled and packaged

meat and meat food products, and result in sundry losses

to livestock producers and processors of meat and meat

food products, as well as injury to consumers. The un-

wholesome, adulterated, mislabeled, or deceptively pack-

aged articles can be sold at lower prices and compete

unfairly with the wholesome, not adulterated, and prop-

erly labeled and packaged articles, to the detriment of

consumers and the public generally. It is hereby found that

all articles and animals which are regulated under this

chapter are either in interstate or foreign commerce or

substantially affect such commerce, and that regulation by

the Secretary and cooperation by the States and other

jurisdictions as contemplated by this chapter are appro-

priate to prevent and eliminate burdens upon such com-

merce, to effectively regulate such commerce, and to

protect the health and welfare of consumers.

21 U.S.C. § 603. Inspection of meat and meat food prod-

ucts

(a) Examination of animals before slaughtering;

diseased animals slaughtered separately and carcasses

examined

For the purpose of preventing the use in commerce of

meat and meat food products which are adulterated, the

Secretary shall cause to be made, by inspectors appointed

30a

for that purpose, an examination and inspection of all

cattle, sheep, swine, goats, horses, mules, and other

equines before they shall be allowed to enter into any

slaughtering, packing, meat-canning, rendering, or similar

establishment, in which they are to be slaughtered and the

meat and meat food products thereof are to be used in

commerce; and all cattle, sheep, swine, goats, horses,

mules, and other equines found on such inspection to show

symptoms of disease shall be set apart and slaughtered

separately from all other cattle, sheep, swine, goats,

horses, mules, or other equines, and when so slaughtered

the carcasses of said cattle, sheep, swine, goats, horses,

mules, or other equines shall be subject to a careful

examination and inspection, all as provided by the rules

and regulations to be prescribed by the Secretary, as

provided for in this subchapter.

(b) Humane methods of slaughter

For the purpose of preventing the inhumane slaugh-

tering of livestock, the Secretary shall cause to be made,

by inspectors appointed for that purpose, an examination

and inspection of the method by which cattle, sheep,

swine, goats, horses, mules, and other equines are slaugh-

tered and handled in connection with slaughter in the

slaughtering establishments inspected under this chapter.

The Secretary may refuse to provide inspection to a new

slaughtering establishment or may cause inspection to be

temporarily suspended at a slaughtering establishment if

the Secretary finds that any cattle, sheep, swine, goats,

horses, mules, or other equines have been slaughtered or

handled in connection with slaughter at such establish-

ment by any method not in accordance with the Act of

August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906) until

the establishment furnishes assurances satisfactory to the

3la

Secretary that all slaughtering and handling in connection

with slaughter of livestock shall be in accordance with

such a method.

21 U.S.C. § 604. Post mortem examination of carcasses

and marking or labeling; destruction of carcasses con-

demned; reinspection

For the purposes hereinbefore set forth the Secretary

shall cause to be made by inspectors appointed for that

purpose a post mortem examination and inspection of the

carcasses and parts thereof of all cattle, sheep, swine,

goats, horses, mules, and other equines to be prepared at

any slaughtering, meat-canning, salting, packing, render-

ing, or similar establishment in any State, Territory, or the

District of Columbia as articles of commerce which are

capable of use as human food; and the carcasses and parts

thereof of all such animals found to be not adulterated

shall be marked, stamped, tagged, or labeled as “Inspected

and passed”; and said inspectors shall label, mark, stamp,

or tag as “Inspected and condemned” all carcasses and

parts thereof of animals found to be adulterated; and all

carcasses and parts thereof thus inspected and condemned

shall be destroyed for food purposes by the said establish-

ment in the presence of an inspector, and the Secretary

may remove inspectors from any such establishment

which fails to so destroy any such condemned carcass or

part thereof, and said inspectors, after said first inspec-

tion, shall, when they deem it necessary, reinspect said

carcasses or parts thereof to determine whether since the

first inspection the same have become adulterated, and if

any carcass or any part thereof shall, upon examination

and inspection subsequent to the first examination and

inspection, be found to be adulterated, it shall be

32a

destroyed for food purposes by the said establishment in

the presence of an inspector, and the Secretary may

remove inspectors from any establishment which fails to

so destroy any such condemned carcass or part thereof.

21 U.S.C. § 605. Examination of carcasses brought into

slaughtering or packing establishments, and of meat food

products issued from and returned thereto; conditions for

entry

The foregoing provisions shall apply to all carcasses or

parts of carcasses of cattle, sheep, swine, goats, horses,

mules, and other equines or the meat or meat products

thereof which may be brought into any slaughtering,

meat-canning, salting, packing, rendering, or similar

establishment, and such examination and inspection shall

be had before the said carcasses or parts thereof shall be

allowed to enter into any department wherein the same

are to be treated and prepared for meat food products; and

the foregoing provisions shall also apply to all such prod-

ucts, which, after having been issued from any slaughter-

ing, meat-canning, salting, packing, rendering, or similar

establishment, shall be returned to the same or to any

similar establishment where such inspection is main-

tained. The Secretary may limit the entry of carcasses,

parts of carcasses, meat and meat food products, and other

materials into any establishment at which inspection

under this title [21 U.S.C.A. §§ 601 et seq.] is maintained,

under such conditions as he may prescribe to assure that

allowing the entry of such articles into such inspected

establishments will be consistent with the purposes of this

chapter.

33a

21 U.S.C. § 606. Inspectors of meat food products; marks of

inspection; destruction of condemned products; products

for export

For the purposes hereinbefore set forth the Secretary

shall cause to be made, by inspectors appointed for that

purpose, an examination and inspection of all meat food

products prepared for commerce in any slaughtering,

meat-canning, salting, packing, rendering, or similar

establishment, and for the purposes of any examination

and inspection said inspectors shall have access at all

times, by day or night, whether the establishment be

operated or not, to every part of said establishment; and

said inspectors shall mark, stamp, tag, or label as “In-

spected and passed” all such products found to be not

adulterated; and said inspectors shall label, mark, stamp,

or tag as “Inspected and condemned” all such products

found adulterated, and all such condemned meat food

products shall be destroyed for food purposes, as hereinbe-

fore provided, and the Secretary may remove inspectors

from any establishment which fails to so destroy such

condemned meat food products: Provided, That subject to

the rules and regulations of the Secretary the provisions of

this section in regard to preservatives shall not apply to

meat food products for export to any foreign country and

which are prepared or packed according to the specifica-

tions or directions of the foreign purchaser, when no

substance is used in the preparation or packing thereof in

conflict with the laws of the foreign country to which said

article is to be exported; but if said article shall be in fact

sold or offered for sale for domestic use or consumption

then this proviso shall not exempt said article from the

operation of all the other provisions of this chapter.

34a

21 U.S.C. § 607. Labeling, marking, and container re-

quirements

(a) Labeling receptacles or coverings of meat or meat

food products inspected and passed; supervision by inspec-

tors

When any meat or meat food product prepared for

commerce which has been inspected as hereinbefore

provided and marked “Inspected and passed” shall be

placed or packed in any can, pot, tin, canvas, or other

receptacle or covering in any establishment where inspec-

tion under the provisions of this chapter is maintained,

the person, firm, or corporation preparing said product

shall cause a label to be attached to said can, pot, tin,

canvas, or other receptacle or covering, under the supervi-

sion of an inspector, which label shall staie that the

contents thereof have been “inspected and passed” under

the provisions of this chapter; and no inspection and

examination of meat or meat food products deposited or

inclosed in cans, tins, pots, canvas, or other receptacle or

covering in any establishment where inspection under the

provisions of this chapter is maintained shall be deemed to

be complete until such meat or meat food products have

been sealed or inclosed in said can, tin, pot, canvas, or

other receptacle or covering under the supervision of an

inspector.

(b) Information on articles or containers; legible form

All carcasses, parts of carcasses, meat and meat food

products inspected at any establishment under the

authority of this title [21 U.S.C.A. §§ 601 et seq.] and

found to be not adulterated, shall at the time they leave

the establishment bear, in distinctly legible form, directly

thereon or on their containers, as the Secretary may

35a

require, the information required under paragraph (n) of

section 601 of this title.

standards of identity or composition; standards of fill of

container; consistency of Federal and Federal-State

standards

The Secretary, whenever he determines such action is

necessary for the protection of the public, may prescribe: (1)

the styles and sizes of type to be used with respect to mate-

rial required to be incorporated in labeling to avoid false or

misleading labeling in marketing and labeling any articles or

animals subject to this title [21 U.S.C.A. §§ 601 et seq.] or

Title II of this Act [21 U.S.C.A. §§ 641 et seq.]; (2) definitions

and stand rds of identity or composition for articles subject

to this title [21 U.S.C.A. §§ 601 et seq.] and standards of fill

of container for such articles not inconsistent with any such

standards established under the Federal Food, Drug, and

Cosmetic Act [21 U.S.C.A. § 301 et seq.], and there shall be

consultation between the Secretary and the Secretary of

Health and Human Services prior to the issuance of such

standards under either Act relating to articles subject to this

chapter to avoid inconsistency in such standards and possi-

ble impairment of the coordinated effective administration of

these Acts. There shall also be consultation between the

Secretary and an appropriate advisory committee provided

for in section 661 of this title, prior to the issuance of such

standards under this chapter, to avoid, insofar as feasible,

inconsistency between Federal and State standards.

(d) Sales under false or misleading name, other

marking or labeling or in containers of misleading form

or size; trade names, and other marking, labeling, and

centainers approved by Secretary

36a

No article subject to this title (21 U.S.C.A. §§ 601 et

seq.] shall be sold or offered for sale by any person, firm, or

corporation, in commerce, under any name or other mark-

ing or labeling which is false or misleading, or in any

container of a misleading form or size, but established

trade names and other marking and labeling and contain-

ers which are not false or misleading and which are

approved by the Secretary are permitted.

(e) Use withholding directive respecting false or

misleading marking, labeling, or container; modification of

false or misleading matter; hearing; withholding use

pending proceedings; finality of Secretary’s action; judicial

review; application of section 194 of Title 7

If the Secretary has reason to believe that any mark-

ing or labeling or the size or form of any container in use

or proposed for use with respect to any article subject to

this title [21 U.S.C.A. §§ 601 et seq.] is false or misleading

in any particular, he may direct that such use be withheld

unless the marking, labeling, or container is modified in

such manner as he may prescribe so that it will not be

false or misleading. If the person, firm, or corporation

using or proposing to use the marking, labeling or con-

tainer does not accept the determination of the Secretary,

such person, firm, or corporation may request a hearing,

but the use of the marking, labeling, or container shall, if

the Secretary so directs, be withheld pending hearing and

final determination by the Secretary. Any such determina-

tion by the Secretary shall be conclusive unless, within

thirty days after receipt of notice of such final determina-

tion, the person, firm, or corporation adversely affected

thereby appeals to the United States court of appeals for

the circuit in which such person, firm, or corporation has

its principal place of business or to the United States

37a

Court of Appeals for the District of Columbia Circuit. The

provisions of section 194 of Title 7 shall be applicable to

appeals taken under this section.

(f) Lamb and mutton

The Secretary, consistent with United States interna-

tional obligations, shall establish standards for the label-

ing of sheep carcasses, parts of sheep carcasses,

sheepmeat, and sheepmeat food products.

21 U.S.C. § 608. Sanitary inspection and regulation of

slaughtering and packing establishments; rejection of

adulterated meat or meat food products

The Secretary shall cause to be made, by experts in

sanitation or by other competent inspectors, such inspec-

tion of all slaughtering, meat canning, salting, packing,

rendering, or similar establishments in which cattle,

sheep, swine, goats, horses, mules and other equines are

slaughtered and the meat and meat food products thereof

are prepared for commerce as may be necessary to inform

himself concerning the sanitary conditions of the same,

and to prescribe the rules and regulations of sanitation

under which such establishments shall be maintained; and

where the sanitary conditions of any such establishment

are such that the meat or meat food products are rendered

adulterated, he shall refuse to allow said meat or meat

food products to be labeled, marked, stamped or tagged as

“inspected and passed.”

38a

21 U.S.C. § 609. Examination of animals and food products

thereof, slaughtered and prepared during nighttime

The Secretary shall cause an examination and inspec-

tion of all cattle, sheep, swine, goats, horses, mules and

other equines, and the food products thereof, slaughtered

and prepared in the establishments hereinbefore described

for the purposes of commerce to be made during the

nighttime as well as during the daytime when the slaugh-

tering of said cattle, sheep, swine, goats, horses, mules,

and other equines, or the preparation of said food products

is conducted during the nighttime.

21 U.S.C. § 610. Prohibited acts

No person, firm, or corporation shall, with respect to

any cattle, sheep, swine, goats, horses, mules, or other

equines, or any carcasses, parts of carcasses, meat or meat

food =~oducts of any such animals —

(a) Slaughtering animals or preparation of articles

capable of use as human food

slaughter any such animals or prepare any such arti-

cles which are capable of use as human food at any

establishment preparing any such articles for com-

merce, except in compliance with the requirements of

this chapter;

(b) Humane methods of slaughter

slaughter or handle in connection with slaughter any

such animals in any manner not in accordance with

the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C.

1901-1906);

39a

sell, transport, offer for sale or transportation, or receive

for transportation, in commerce, (1) any such articles

which (A) are capable of use as human food and (B) are

adulterated or misbranded at the time of such sale,

transportation, offer for sale or transportation, or re-

ceipt for transportation; or (2) any articles required to

be inspected under this title [21 U.S.C.A. §§ 601 et seq.]

unless they have been so inspected and passed;

(d) Adulteration or misbranding

do, with respect to any such articles which are capa-

ble of use as human food, any act while they are being

transported in commerce or held for sale after such

transportation, which is intended to cause or has the

effect of causing such articles to be adulterated or

misbranded.

21 U.S.C. § 611. Devices, marks, labels, and certificates;

simulations

(a) Devices to be made under authorization of

Secretary

No brand manufacturer, printer, or other person, firm,

or corporation shall cast, print, lithograph, or otherwise

make any device containing any official mark or simula-

tion thereof, or any label bearing any such mark or simu-

lation, or any form of official certificate or simulation

thereof, except as authorized by the Secretary.

(b) Other misconduct

No person, firm, or corporation shall —

(1) forge any official device, mark, or certificate;

40a

(2) without authorization from the Secretary use any

official device, mark, or certificate, or simulation thereof,

or alter, detach, deface, or destroy any official device,

mark, or certificate;

(3) contrary to the regulations prescribed by the

Secretary, fail to use, or to detach, deface, or destroy any

officia! device, mark, or certificate;

(4) knowingly possess, without promptly notifying

the Secretary or his representative, any official device or

any counterfeit, simulated, forged, or improperly altered

official certificate or any device or label or any carcass of

any animal, or part or product thereof, bearing any coun-

terfeit, simulated, forged, or improperly altered official

mark;

(5) knowingly make any false statement in any

shipper’s certificate or other nonofficial or official certifi-

cate provided for in the regulations prescribed by the

Secretary; or

(6) knowingly represent that any article has been

inspected and passed, or exempted, under this chapter

when, in fact, it has, respectively, not been so inspected

and passed, or exempted.

21 U.S.C. §§ 612 to 614. Repealed

21 U.S.C. § 615. Inspection of carcasses, meat of which is

intended for export

The Secretary shall also cause to be made a careful

inspection of the carcasses and parts thereof of all cattle,

4la

sheep, swine, goats, horses, mules, and other equines, the

meat of which, fresh, salted, canned, corned, packed,

cured, or otherwise prepared, is intended and offered for

export to any foreign country, at such times and places and

in such manner as he may deem proper.

21 U.S.C. § 616. Inspectors of carcasses, etc., meat of

which is intended for export; certificates:of condition

For the purpose of section 615 of this title the Secre-

tary may appoint inspectors who shall be authorized to

give an official certificate stating the condition in which

said cattle, sheep, swine, goats, horses, mules, or other

equines, and the meat thereof, are found.

21 U.S.C. § 617. Clearance prohibited to vessel carrying

meat for export without inspector’s certificate

No clearance shall be given to any vessel having on

board any fresh, salted, canned, corned, or packed beef,

mutton, pork, goat or equine meat for export to and sale in

a foreign country from any port in the United States, until

the owner or shipper thereof shall obtain from an inspec-

tor appointed under the provisions of this chapter a

certificate that the said cattle, sheep, swine, goats, horses,

mules, and other equines were sound and healthy at the

time of inspection, and that their meat is sound and

wholesome, unless the Secretary shall have waived the

requirements of such certificate for the country to which

said cattle, sheep, swine, goats, horses, mules, and other

equines or meats are to be exported.

42a

21 U.S.C. § 618. Delivery of inspectors’ certificates, and of

copies

The inspectors provided for under this subchapter

shall be authorized to give official certificates of the

condition of the carcasses and products of cattle, sheep,

swine, goats, horses, mules, and other equines; and one

copy of every certificate granted under the provisions of

this chapter shall be filed in the Department of Agricul-

ture, another copy shall be delivered to the owner or

shipper, and when the cattle, sheep, swine, goats, horses,

mules, and other equines, or their carcasses and products

are sent abroad, a third copy shall be delivered to the chief

officer of the vessel on which the shipment shall be made.

21 U.S.C. § 619. Marking, labeling, or other identification

of kinds of animals or articles’ derivation; separate estab-

lishments for preparation and slaughtering activities

No person, firm, or corporation shall sell, transport, offer

for sale or transportation, or receive for transportation, in

commerce, any carcasses of horses, mules, or other equines

or parts of such carcasses, or the meat or meat food products

thereof, unless they are plainly and conspicuously marked or

labeled or otherwise identified as required by regulations

prescribed by the Secretary to show the kinds of animals

from which they were derived. When required by the Secre-

tary, with respect to establishments at which inspection is

maintained under this title [21 U.S.C.A. §§ 601 et seq.], such

animals and their carcasses, parts thereof, meat and meat

food products shall be prepared in establishments separate

from those in which cattle, sheep, swine, or goats are slaugh-

tered or their carcasses, parts thereof, meat or meat food

products are prepared.

21 U.S.C. § 620. Imports

(a) Adulteration or misbranding prohibition; compli-

ance with inspection, building construction standards, and

other provisions; humane methods of slaughter; treatment

as domestic articles subject to this chapter and food, drug,

and cosmetic provisions; marking and labeling; personal

consumption exemption

No carcasses, parts of carcasses, meat or meat food

products of cattle, sheep, swine, goats, horses, mules, or

other equines which are capable of use as human food,

shall be imported into the United States if such articles

are adulterated or misbranded and unless they comply

with all the inspection, building construction standards,

and all other provisions of this chapter and regulations

issued thereunder applicable to such articles in commerce

within the United States. No such carcasses, parts of

carcasses, meat or meat food products shall be imported

into the United States unless the livestock from which

they were produced was slaughtered and handled in

connection with slaughter in accordance with the Act of

August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906). All

such imported articles shall, upon entry into the United

States, be deemed and treated as domestic articles subject

to the other provisions of this chapter and the Federal

Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et seq.]:

Provided, That they shall be marked and labeled as

required by such regulations for imported articles: Pro-

vided further, That nothing in this section shall apply to

any individual who purchases meat or meat products

outside the United States for his own consumption except

that the total amount of such meat or meat products shall

not exceed fifty pounds.

44a

(b) Terms and conditions for destruction

The Secretary may prescribe the terms and conditions

for the destruction of all such articles which are imported

contrary to this section, unless (1) they are exported by the

consignee within the time fixed therefor by the Secretary,

or (2) in the case of articles which are not in compliance

with the chapter solely because of misbranding, such

articles are brought into compliance with the chapter

under supervision of authorized representatives of the

Secretary.

owner or consignee; liens

All charges for storage, cartage, and labor with re-

spect to any article which is imported contrary to this

section shall be paid by the owner or consignee, and in

default of such payment shall constitute a lien against

such article and any other article thereafter imported

under this chapter by or for such owner or consignee.

(d) Prohibition

The knowing importation of any article contrary to

this section is prohibited.

(e) Omitted

(f) Inspection and other standards; applicability,

enforcement, etc.; certifications

Notwithstanding any other provision of law, all

carcasses, parts of carcasses, meat, and meat food prod-

ucts of cattle, sheep, swine, goats, horses, mules, or other

equines, capable of use as human food, offered for impor-

tation into the United States shall be subject to the

45a

inspection, sanitary, quality, species verification, and

residue standards applied to products produced in the

United States. Any such imported meat articles that do

not meet such standards shall not be permitted entry into

the United States. The Secretary shall enforce this provi-

sion through (1) the imposition of random inspections for

such species verification and for residues, and (2) random

sampling and testing of internal organs and fat of the

carcasses for residues at the point of slaughter by the

exporting country in accordance with methods approved by

the Secretary. Each foreign country from which such meat

articles are offered for importation into the United States

shall obtain a certification issued by the Secretary stating

that the country maintains a program using reliable

analytical methods to ensure compliance with the United

States standards for residues in such meat articles. No

such meat article shall be permitted entry into the United

States from a country for which the Secretary has not

issued such certification. The Secretary shall periodically

review such certifications and shall revoke any certifica-

tion if the Secretary determines that the country involved

is not maintaining a program that uses reliable analytical

methods to ensure compliance with United States stan-

dards for residues in such meat articles. The consideration

of any application for a certification under this subsection

and the review of any such certification, by the Secretary,

shall include the inspection of individual establishments to

ensure that the inspection program of the foreign country

involved is meeting such United States standards.

(g) Administration of animal drugs or antibiotics;

terms and conditions; entry order violations

The Secretary may prescribe terms and conditions

under which cattle, sheep, swine, goats, horses, mules, and

46a

other equines that have been administered an animal drug

or antibiotic banned for use in the United States may be

imported for slaughter and human consumption. No

person shall enter cattle, sheep, swine, goats, horses,

mules, and other equines into the United States in viola-

tion of any order issued under this subsection by the

Secretary.

(h) Reciprocal meat inspection requirement

(1) As used in this subsection:

(A) The term “meat articles” means carcasses, meat

and meat food products of cattle, sheep, swine, goats,

horses, mules, or other equines, that are capable of use as

human food.

(B) The term “standards” means inspection, building

construction, sanitary, quality, species verification, resi-

due, and other standards that are applicable to meat

articles.

(2) On request of the Committee on Agriculture or

the Committee on Ways and Means of the House of Repre-

sentatives or the Committee on Agriculture, Nutrition,

and Forestry or the Committee on Finance of the Senate,

or at the initiative of the Secretary, the Secretary shall, as

soon as practicable, determine whether a particular

foreign country applies standards for the importation of

meat articles from the United States that are not related

to public health concerns about end-product quality that

can be substantiated by reliable analytical methods.

(3) If the Secretary determines that a foreign coun-

try applies standards described in paragraph (2) —

47a

(A) the Secretary shall consult with the United

States Trade Representative; and

(B) within 30 days after the determination of the

Secretary under paragraph (2), the Secretary and the

United States Trade Representative shall recommend to

the President whether action should be taken under

paragraph (4).

(4) Within 30 days after receiving a recommendation

for action under paragraph (3), the President shall, if and

for such time as the President considers appropriate,

prohibit imports into the United States of any meat

articles produced in such foreign country unless it is

determined that the meat articles produced in that coun-

try meet the standards applicable to meat articles in

commerce within the United States.

(5) The action authorized under paragraph (4) may

be used instead of, or in addition to, any other action taken

under any other law.

21 U.S.C. § 621. Inspectors to make examinations provided

for; appointment; duties; regulations

The Secretary shall appoint from time to time inspec-

tors to make examination and inspection of all cattle,

sheep, swine, goats, horses, mules, and other equines,

inspection of which is hereby provided for, and of all

carcasses and parts thereof, and of all meats and meat

food products thereof, and of the sanitary conditions of all

establishments in which such meat and meat food prod-

ucts hereinbefore described are prepared; and said inspec-

tors shall refuse to stamp, mark, tag, or label any carcass

or any part thereof, or meat food product therefrom,

48a

prepared in any establishment hereinbefore mentioned,

until the same shall have actually been inspected and

found to be not adulterated: and shall perform such other

duties as are provided by this chapter and by the rules and

regulations to be prescribed by said Secretary; and said

Secretary shall, from time to time, make such rules and

regulations as are necessary for the efficient execution of

the provisions of this chapter, and all inspections and

examinations made under this chapter, shall be such and

made in such manner as described in the rules and regula-

tions prescribed by said Secretary not inconsistent with

provisions of this charter.

21 U.S.C. § 622. Bribery of, or gifts to, inspectors or other

officers and acceptance of gifts

Any person, firm, or corporation, or any agent or

employee of any person, firm, or corporation, who shall

give, pay, or offer, directly or indirectly, to any inspector,

deputy inspector, chief inspector, or any other officer or

employee of the United States authorized to perform any

of the duties prescribed by this chapter or by the rules and

regulations of the Secretary any money or other thing of

value, with intent to influence said inspector, deputy

inspector, chief inspector, or other officer or employee of

the United States in the discharge of any duty provided for

in this chapter, shall be deemed guilty of a felony, and,

upon conviction thereof, shall be punished by a fine not

less than $5,000 nor more than $10,000 and by imprison-

ment not less than one year nor more than three years;

and any inspector, deputy inspector, chief inspector, or

other officer or employee of the United States authorized

to perform any of the duties prescribed by this chapter

who shall accept any money, gift, or other thing of value

49a

from any person, firm, or corporation, or officers, agents,

or employees thereof, given with intent to influence his

official action, or who shall receive or accept from any

person, firm, or corporation engaged in commerce any gift,

money, or other thing of value, given with any purpose or

intent whatsoever, shall be deemed guilty of a felony and

shall, upon conviction thereof, be summarily discharged

from office and shall be punished by a fine not less than

$1,000 nor more than $10,000 and by imprisonment not

less than one year nor more than three years.

21 U.S.C. § 623. Exemptions from inspection requirements

(a) Personal slaughtering and custom slaughtering

for personal, household, guest, and employee uses

The provisions of this title [21 U.S.C.A. §§ 601 et seq.]

requiring inspection of the slaughter of animals and the

preparation of the carcasses, parts thereof, meat and meat

food products at establishments conducting such opera-

tions for commerce shall not apply to the slaughtering by

any person of animals of his own raising, and the prepara-

tion by him and transportation in commerce of the car-

casses, parts thereof, meat and meat food products of such

animals exclusively for use by him and members of his

household and his nonpaying guests and employees; nor to

the custom slaughter by any person, firm, or corporation of

cattle, sheep, swine or goats delivered by the owner

thereof for such slaughter, and the preparation by such

slaughterer and transportation in commerce of the car-

casses, parts thereof, meat and meat food products of such

animals, exclusively for use, in the household of such

owner, by him and members of his household and his

nonpaying guests and employees; nor to the custom

50a

preparation by any person, firm, or corporation of car-

casses, parts thereof, meat or meat food products, derived

from the slaughter by any person of cattle, sheep, swine,

or goats of his own raising, or from game animals, deliv-

ered by the owner thereof for such custom preparation,

and transportation in commerce of such custom prepared

articles, exclusively for use in the household of such owner,

by him and members of his household and his nonpaying

guests and employees: Provided, That in cases where such

person, firm, or corporation engages in such custom

operations at an establishment at which inspection under

this title [21 U.S.C.A. §§ 601 et seq.] is maintained, the

Secretary may exempt from such inspection at such

establishment any animals slaughtered or any meat or

meat food products otherwise prepared on such custom

basis: Provided further, That custom operations at any

establishment shall be exempt from inspection require-

ments as provided by this section only if the establishment

complies with regulations which the Secretary is hereby

authorized to promulgate to assure that any carcasses,

parts thereof, meat or meat food products wherever

handled on a custom basis, or any containers or packages

containing such articles, are separated at all times from

carcasses, parts thereof, meat or meat food products

prepared for sale, and that all such articles prepared on a

custom basis, or any containers or packages containing

such articles, are plainly marked “Not for Sale” immedi-

ately after being prepared and kept so identified until

delivered to the owner and that the establishment con-

ducting the custom operation is maintained and operated

in a sanitary manner.

(b) Territorial exemption; refusal, withdrawal, or

modification

5la

The Secretary may, under such sanitary conditions as

he may by regulations prescribe, exempt from the inspec-

tion requirements of this title [21 U.S.C.A. §§ 601 et seq.]

the slaughter of animals, and the preparation of carcasses,

parts thereof, meat and meat food products, by any person,

firm, or corporation in any Territory not organized with a

legislative body solely for distribution within such Terri-

tory when the Secretary determines that it is impractica-

ble to provide such inspection within the limits of funds

appropriated for administration of this chapter and that

such exemption will otherwise facilitate enforcement of

this chapter. The Secretary may refuse, withdraw, or

modify any exemption under this subsection in his discre-

tion whenever he determines such action is necessary to

effectuate the purposes of this chapter.

(1) Under such terms and conditions as the Secre-

tary shall prescribe through ruies and regulations issued

under section 624 of this title that may be necessary to

ensure food safety and protect public health such as

special handling procedures, the Secretary shali exempt

pizzas containing a meat food product from the inspection

requirements of this chapter if —

(A) the meat food product components of the pizzas

have been prepared, inspected, and passed in a cured or

cooked form as ready-to-eat in compliance with the re-

quirements of this chapter; and

(B) the pizzas are to be served in public or private

nonprofit institutions.

(2) The Secretary may withdraw or modify any

exemption under this subsection whenever the Secretary

52a

determines such action is necessary to ensure food safety

and to protect public health. The Secretary may reinstate

or further modify any exemption withdrawn or modified

under this subsection.

(d) Adulteration and misbranding provisions appli-

cable to inspection-free articles

The adulteration and misbranding provisions of this

title [21 U.S.C.A. §§ 601 et seq.], other than the require-

ment of the inspection legend, shall apply to articles which

are exempted from inspection or not required to be in-

spected under this section.

21 U.S.C. § 624. Storage and handling regulations; viola-

tions; exemption of establishments subject to non-Federal

jurisdiction

The Secretary may by regulations prescribe conditions

under which carcasses, parts of carcasses, meat, and

meat food products of cattle, sheep, swine, goats, horses,

mules, or other equines, capable of use as human food,

shall be stored or otherwise handled by any person, firm,

or corporation engaged in the business of buying, selling,

freezing, storing, or transporting, in or for commerce, or

importing, such articles, whenever the Secretary deems

such action necessary to assure that such articles will not

be adulterated or misbranded when delivered to the

consumer. Violation of any such regulation is prohibited.

However, such regulations shall not apply to the storage

or handling of such articles at any retail store or other

establishment in any State or organized Territory that

would be subject to this section only because of purchases

in commerce, if the storage and handling of such articles

53a

at such establishment is regulated under the laws of the

Sta’. or Territory in which such establishment is located,

in a manner which the Secretary, after consultation with

the appropriate advisory committee provided for in section

661 of this title, determines is adequate to effectuate the

purposes of this section.

9 C.F.R. part 417

9 C.F.R. § 417.1 Definitions.

For purposes of this part, the following definitions

shall apply:

Corrective action. Procedures to be followed when a

deviation occurs.

Critical control point. A point, step, or procedure in a

food process at which control can be applied and, as a

result, a food safety hazard can be prevented, eliminated,

or reduced to acceptable levels.

Critical limit. The maximum or minimum value to

which a physical, biological, or chemical hazard must be

controlled at a critical control point to prevent, eliminate,

or reduce to an acceptable level the occurrence of the

identified food safety hazard.

Food safety hazard. Any biological, chemical, or

physical property that may cause a food to be unsafe for

human consumption.

HACCP System. The HACCP plan in operation,

including the HACCP plan itself.

Hazard. SEE Food Safety Hazard.

54a

Preventive measure. Physical, chemical, or other

means that can be used to control an identified food safety

hazard.

Process-monitoring instrument. An instrument or

device used to indicate conditions during processing at a

critical control point.

Responsible establishment official. The individual

with overall authority on-site or a higher level official of

the establishment.

9 C.F.R. § 417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis. (1) Every official establishment

shall conduct, or have conducted for it, a hazard analysis

to determine the food safety hazards reasonably likely to

occur in the production process and identify the preventive

measures the establishment can apply to control those

hazards. The hazard analysis shall include food safety

hazards that can occur before, during, and after entry into

the establishment. A food safety hazard that is reasonably

likely to occur is one for which a prudent establishment

would establish controls because it historically has oc-

curred, or because there is a reasonable possibility that it

will occur in the particular type of product being proc-

essed, in the absence of those controls.

(2) A flow chart describing the steps of each process

and product flow in the establishment shall be prepared,

and the intended use or consumers of the finished product

shall be identified.

(3) Food safety hazards might be expected to arise

from the following:

(i) Natural toxins;

Gi) Microbiological contamination;

(ii1) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Zoonotic diseases;

(vii) Decomposition;

(viii) Parasites;

(ix) Unapproved use of direct or indirect food or color

additives; and

(x) Physical hazards.

(b) The HACCP plan. (1) Every establishment shall

develop and implement a written HACCP plan covering

each product produced by that establishment whenever a

hazard analysis reveals one or more food safety hazards

that are reasonably likely to occur, based on the hazard

analysis conducted in accordance with paragraph (a) of

this section, including products in the following processing

categories:

(i) Slaughter ~ all species.

(ii) Raw product — ground.

(ii) Raw product — not ground.

(iv) Thermally processed — commercially sterile.

(v) Not heat treated — shelf stable.

(vi) Heat treated — shelf stable.

56a

(vii) Fully cooked — not shelf stable.

(vii) Heat treated but not fully cooked — not shelf

stable.

(ix) Product with secondary inhibitors — not shelf

stable:

(2) A single HACCP plan may encompass multiple

products within a single processing category identified in

this paragraph, if the food safety hazards, critical control

points, critical limits, and procedures required to be

identified and performed in paragraph (c) of this section

are essentially the same, provided that any required

features of the plan that are unique to a specific product

are clearly delineated in the plan and are observed in

practice.

(3) HACCP plans’ for’ thermally processed/

commercially sterile products do not have to address the

food safety hazards associated with microbiological con-

tamination if the product is produced in accordance with

the requirements of part 318, subpart G, or part 381,

subpart X, of this chapter.

plan shall, at a minimum:

(1) List the food safety hazards identified in accor-

dance with paragraph (a) of this section, which must be

controlled for each process.

(2) List the critical control points for each of the

identified food safety hazards, including, as appropriate:

57a

(i) Critical control points designed to control food

safety hazards that could be introduced in the establish-

ment, and

(ii) Critical control points designed to control food

safety hazards introduced outside the establishment,

including food safety hazards that occur before, during,

and after entry into the establishment;

(3) List the critical limits that must be met at each of

the critical control points. Critical limits shall, at a mini-

mum, be designed to ensure that applicable targets or

performance standards established by FSIS, and any other

requirement set forth in this chapter pertaining to the

specific process or product, are met;

(4) List the procedures, and the frequency with

which those procedures will be performed, that will be

used to monitor each of the critical control points to ensure

compliance with the critical limits;

(5) Include all corrective actions that have been

developed in accordance with Sec. 417.3(a) of this part, to

be followed in response to any deviation from a critical

limit at a critical control point; and

(6) Provide for a recordkeeping system that docu-

ments the monitoring of the critical control points. The

records shall contain the actual values and observations

obtained during monitoring.

(7) List the verification procedures, and the fre-

quency with which those procedures will be performed,

that the establishment will use in accordance with Sec.

417.4 of this part.

58a

{d) Signing and dating the HACCP plan. (1) The

HACCP plan shall be signed and dated by the responsible

establishment individual. This signature shall signify that

the establishment accepts and will implement the HACCP

plan.

(2) The HACCP plan shall be dated and signed:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) At least annually, upon reassessment, as re-

quired under Sec. 417.4(a)(3) of this part.

(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the

failure of an establishment to develop and implement a

HACCP plan that complies with this section, or to operate

in accordance with the requirements of this part, may

render the products produced under those conditions

adulterated.

9 C.F.R. § 417.3 Corrective actions.

(a) The written HACCP plan shali identify the

corrective action to be followed in response to a deviation

from a critical limit. The HACCP plan shall describe the

corrective action to be taken, and assign responsibility for

taking corrective action, to ensure:

(1) The cause of the deviation is identified and

eliminated;

(2) The CCP will be under control after the correc-

tive action is taken;

59a

(3) Measures to prevent recurrence are established;

and

(4) No product that is injurious to health or other-

wise adulterated as a result of the deviation enters com-

merce.

(b) If a deviation not covered by a specified corrective

action occurs, or if another unforeseen hazard arises, the

establishment shall:

(1) Segregate and hold the affected product, at least

until the requirements of paragraphs (b)(2) and (b)(3) of

this section are met;

(2) Perform a review to determine the acceptability

of the affected product for distribution;

(3) Take action, when necessary, with respect to the

affected product to ensure that no product that is injurious

to health or otherwise adulterated, as a result of the

deviation, enters commerce;

(4) Perform or obtain reassessment by an individual

trained in accordance with Sec. 417.7 of this part, to

determine whether the newly identified deviation or other

unforeseen hazard should be incorporated into the HACCP

plan.

this section shall be documented in records that are

subject to verification in accordance with Sec.

417.4(a)(2)(iii) and the recordkeeping requirements of Sec.

417.5 of this part.

60a

9C.F.R.§ 417.4 Validation, Verification, Reassessment.

(a) Every establishment shall validate the HACCP

plan’s adequacy in controlling the food safety hazards

identified during the hazard analysis, and shall verify that

the plan is being effectively implemented.

(1) Initial validation. Upon completion of the hazard

analysis and development of the HACCP plan, the estab-

lishment shall conduct activities designed to determine

that the HACCP plan is functioning as intended. During

this HACCP plan validation period, the establishment

shall repeatedly test the adequacy of the CCP’s, critical

limits, monitoring and recordkeeping procedures, and

corrective actions s.* forth in the HACCP plan. Validation

also encompasses reviews of the records themselves,

routinely generated by the HACCP system, in the context

of other validation activities.

(2) Ongoing verification activities. Ongoing verifica-

tion activities include, but are not limited to:

i) The calibration of process-monitoring instru-

ments;

(ii) Direct observations of monitoring activities and

corrective actions; and

(iii) The review of records genersted and maintained

in accordance with Sec. 417.5(a)(3) of this part.

(3) Reassessment of the HACCP plan. Every estab-

lishment shall reassess the adequacy of the HACCP plan

at least annually and whenever any changes occur that

could affect the hazard analysis or alter the HACCP plan.

Such changes may include, but are not limited to, changes

in: raw materials or source of raw materials; product

6la

formulation; slaughter or processing methods or systems;

production volume; personnel; packaging; finished product

distribution systems; or, the intended use or consumers of

the finished product. The reassessment shall be performed

by an individual trained in accordance with Sec. 417.7 of

this part. The HACCP plan shall be modified immediately

whenever a reassessment réveals that the plan no longer

meets the requirements of Sec. 417.2(c) of this part.

(b) Reassessment of the hazard analysis. Any estab-

lishment that does not have a HACCP plan because a

hazard analysis has revealed no food safety hazards that

are reasonably likely to occur shall reassess the adequacy

of the hazard analysis whenever a change occurs that

could reasonably affect whether a food safety hazard

exists. Such changes may include, but are not limited to,

changes in: raw materials or source of raw materials;

product formulation; slaughter or processing methods or

systems; production volume; packaging; finished product

distribution systems; or, the intended use or consumers of

the finished product.

9 C.F.R. § 417.5 Records.

(a) The establishment shall maintain the following

records documenting the establishment’s HACCP plan:

(1) The written hazard analysis prescribed in Sec.

417.2(a) of this part, including all supporting documenta-

tion;

(2) The written HACCP plan, including decisionmak-

ing documents associated with the selection and develop-

ment of CCP’s and critical lhmits, and documents

62a

supporting both the monitoring and verification proce-

dures selected and the frequency of those procedures.

(3) Records documenting the monitoring of CCP’s

and their critical limits, including the recording of actual

times, temperatures, or other quantifiable values, as

prescribed in the establishment’s HACCP plan; the cali-

bration of process-monitoring instruments; corrective

actions, including all actions taken in response to a devia-

tion; verification procedures and results; product code(s),

product name or identity, or slaughter production lot. Each

of these records shall include the date the record was

made.

(b) Each entry on a record maintained under the

HACCP plan shall be made at the time the specific event

occurs and include the date and time recorded, and shall

be signed or initialed by the establishment employee

making the entry.

review the records associated with the production of that

product, documented in accordance with this section, to

ensure completeness, including the determination that all

critical limits were met and, if appropriate, corrective

actions were taken, including the proper disposition of

product. Where practicable, this review shall be conducted,

dated, and signed by an individual who did not produce

the record(s), preferably by someone trained in accordance

with Sec. 417.7 of this part, or the responsible establish-

ment official.

(d) Records maintained on computers. The use of

records maintained on computers is acceptable, provided

that appropriate controls are implemented to ensure the

integrity of the electronic data and signatures.

63a

(e) Record retention. (1) Establishments shall retain

all records required by paragraph (a)(3) of this section as

follows: for slaughter activities for at least one year; for

refrigerated product, for at least one year; for frozen,

preserved, or shelf-stable products, for at least two years.

(2) Off-site storage of records required by paragraph

(a)(3) of this section is permitted after six months, if such

records can be retrieved and provided, on-site, within 24

hours of an FSIS employee’s request.

(f) Official review. All records required by this part

and all plans and procedures required by this part shall be

available for official review and copying.

9 C.F.R. § 417.6 Inadequate HACCP Systems.

A HACCP system may be found to be inadequate if:

(a) The HACCP plan in operation does not meet the

requirements set forth in this part;

(b) Establishment personnel are not performing

tasks specified in the HACCP plan;

as required by Sec. 417.3 of this part; -

(d) HACCP records are not being maintained as

required in Sec. 417.5 of this part; or

(e) Adulterated product is produced or shipped.

64a

9 C.F.R.§ 417.7 Training.

(a) Only an individual who has met the require-

ments of paragraph (b) of this section, but who need not be

an employee of the establishment, shall be permitted to

perform the following functions:

(1) Development of the HACCP plan, in accordance

with Sec. 417.2(b) of this part, which could include adapt-

ing a generic model that is appropriate for the specific

product; and

(2) Reassessment and modification of the HACCP

plan, in accordance with Sec. 417.3 of this part.

(b) The individual performing the functions listed in

paragraph (a) of this section shall have successfully

completed a course of instruction in the application of the

seven HACCP principles to meat or poultry product

processing, including a segment on the development of a

HACCP plan for a specific product and on record review.

9 C.F.R. § 417.8 Agency verification.

FSIS will verify the adequacy of the HACCP plan(s)

by determining that each HACCP plan meets the require-

ments of this part and all other applicable regulations.

Such verification may include:

(a) Reviewing the HACCP plan;

(b) Reviewing the CCP records;

corrective actions taken when a deviation occurs;

(d) Reviewing the critical limits;

65a

(e) Reviewing other records pertaining to the

HACCP plan or system;

(f) Direct observation or measurement at a CCP;

(g) Sample collection and analysis to determine the

product meets all safety standards; and

(h) On-site observations and record review.

9 C.F.R. § 500.2 Regulatory control action.

(a) FSIS may take a regulatory control action be-

cause of:

(1) Insanitary conditions or practices;

(2) Product adulteration or misbranding;

(3) Conditions that preclude FSIS from determining

that product is not adulterated or misbranded; or

(4) Inhumane handling or slaughtering of livestock.

(b) If a regulatory control action is taken, the pro-

gram employee will immediately notify the establishment

orally or in writing of the action and the basis for the

action.

control action, as provided in §§ 306.5 and 381.35 of this

chapter.

66a

9 C.F.R. § 500.5 Notification, appeals, and actions held

in abeyance.

(a) If FSIS takes a withholding action or imposes a

suspension, the establishment will be notified orally and,

as promptly as circumstances permit, in writing. The

written notification will:

(1) State the effective date of the action(s),

(2) Describe the reasons for the action(s),

(3) Identify the products or processes affected by the

action(s),

(4) Provide the establishment an opportunity to

present immediate and corrective action and further

planned preventive action; and

(5) Advise the establishment that it may appeal

the action as provided in §§ 306.5 and 381.35 of this

chapter.

(b) The prior notification provided for in § 500.4 of

this part will:

(1) State the type of action that FSIS may take;

(2) Describe the reason for the proposed action;

(3) Identify the products or processes affected by the

proposed action;

(4) Advise the establishment of its right to contact

FSIS to contest the basis for the proposed action or to

explain how compliance has been or will be achieved; and

(5) Advise the establishment that it will have three

business days from receipt of the written notification to

67a

respond to FSIS uniess the time period is extended by

FSIS.

action or suspension, as provided in §§ 306.5 and 381.35 of

this chapter.

(d) If FSIS suspends inspection and does not hold

the suspension action in abeyance as provided in para-

graph (e) of this section, the establishment may request a

hearing pursuant to the Uniform Rules of Practice, 7 CFR

Subtitle A, part 1, subpart H. Upon such request, the

Administrator will file a complaint that will include a

request for an expedited hearing.

(e) FSIS may hold a suspension in abeyance and

allow the establishment to operate under the conditions

agreed to by FSIS and the establishment.

7 C.F.R. § 1.131 Scope and applicability of this subpart.

(a) The rules of practice in this subpart shall be

applicable to all adjudicatory proceedings under the

statutory provisions listed below as those provisions have

been or may be amended from time to time,’ except that

those rules shall not be applicable to reparation proceed-

ings under section 6(c) of the Perishable Agricultural

Commodities Act, 1930. Section 1.26 shall be inapplicable

to the proceedings covered by this subpart.

* See also the regulations promulgated under these statutes for

any supplemental rules relating to particular circumstances arising

thereunder.

68a

Act of May 29, 1884, commonly known as the Animal

Industry Act, section 7, as amended (21 U.S.C. 117).

Act of August 30, 1890, section 6, as amended (21 U.S.C. 104).

Act of February 2, 1903, commonly known as the Cattle

Contagious Diseases Act of 1903, section 3, as amended

(21 U.S.C. 122).

Act of March 3, 1905, section 6, as amended (21 U.S.C. 127).

Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e).

Act of May 6, 1970, section 2, as amended (21 U.S.C. 135a).

Agricultural Marketing Agreement Act of 1937, as

amended, section 8c(14), 7 U.S.C. 608c(14).

Animal Health Protection Act, section 10414 (7 U.S.C. 8313).

Animal Welfare Act, section 19 (7 U.S.C. 2149).

Beef Promotion and Research Act of 1985, section 9 {7

U.S.C. 2908).

Egg Products Inspection Act, section 18 (21 U.S.C. 1047).

Endangered Species Act of 1973, as amended, section 11(a)

(16 U.S.C. 1540(a)).

Egg Research and Consumer Information Act, as

amended, 7 U.S.C. 2714, Pub. L. 96-276, 94 Stat. 541.

Federal Land Policy and Management Act of 1976, section

506 (43 U.S.C. 1766).

Féderal Meat Inspection Act, sections 4, 6, 7(e), 8, and 401

(21 U.S.C. 604, 606, 607(e), 608, 671).

Federal Seed Act, section 409 (7 U.S.C. 1599).

69a

Fluid Milk Promotion Act of 1990, section 1999L [7 U.S.C.

6411].

Forest Resources Conversation and Shortage Relief Act of

1990, section 492 (16 U.S.C. 620d)

Fresh Cut Flowers and Fresh Cut Greens Promotion and

Consumer Information Act of 1993, section 9 [7 U.S.C.

6808}.

Honey Research, Promotion, and Consumer Information

Act, section 11 (7 U.S.C. 4610).

Horse Protection Act of 1970, sections 4(c) and 6 (15 U.S.C.

1823(c), 1825).

Lacey Act Amendments of 1981, section 4(a) and (b) (16

U.S.C. 3373{a) and (b)).

Lime Research, Promotion, and Consumer Information Act

of 1990, as amended, section 1958 [7 U.S.C. 6207]

Mushroom Promotion, Research, and Consumer Informa-

tion Act of 1990, section 1928 [7 U.S.C. 6107]

Packers and Stockyards Act, 1921, as supplemented,

sections 203, 312, and 401 of the Act, and section 1, 57

Stat. 422, as amended by section 4, 90 Stat. 1249 (7 U.S.C.

193, 204, 213, 221)

Pecan Promotion and Research Act of 1990, section 1914 [7

U.S.C. 6009]

Perishable Agricultural Commodities Act, 1930, sections

1(b)(9), 3(c), 4(d), 6(c), 8(a), 8(b), 8(c), 8(e), 9, and 13(a) (7

U.S.C. 499a(b\(9), 499c(c), 499d(d), 499f{c), 499h(a),

499h(b), 499h(c), 499h(e), 499i, 499m(a))

Plant Protection Act, section 424 (7 U.S.C. 7734).

70a

Pork Promotion, Research, and Consumer Information Act

of 1985, section 1626 (7 U.S.C. 4815).

Potato Research and Promotion Act, as amended, 7 U.S.C.

2621, Pub. L. 97-244, 96 Stat. 310.

Poultry Products Inspection Act, sections 6, 7, 8(d), and 18

(21 U.S.C. 455, 456, 457(d), 467).

Sheep Promotion, Research, and Information Act of 1994

[7 U.S.C. 7107].

Soybean Promotion, Research, and Consumer Information

Act, section 1972 [7 U.S.C. 6307].

Swine Health Protection Act, sections 5 and 6 (7 U.S.C.

3804, 3805).

Title V of the Agricultural Risk Protection Act of 2000,

section 501(a) (7 U.S.C. 2279e).

United States Cotton Standards Act, as supplemented,

section 3 of the Act and section 2 of 47 Stat. 1621 (7 U.S.C.

51b, 53).

United States Grain Standards Act, sections 7(g)(3), 9, 10,

and 17A(d) (7 U.S.C. 79(g)(3), 85, 86, 87f-1(d)).

United States Warehouse Act, sections 12 and 25 (7 U.S.C.

246, 253).

Virus-Serum-Toxin Act (21 U.S.C. 156).

Watermelon Research and Promotion Act, section 1651 (7

U.S.C. 4910).

(b) These rules of practice shall also be applicable to:

(1) Adjudicatory proceedings under the regulations

promulgated under the Agricultural Marketing Act of 1946

71la

(7 U.S.C. 1621 et seq.) for the denial or withdrawal of

inspection, certification, or grading service;

(2) Adjudicatory proceedings under the regulations

promulgated under the Animal Quarantine and Related

Laws (21 U.S.C. 111 et seq.) for the suspension or revoca-

tion of accreditation of veterinarians (9 CFR parts 160,

161);

(3) Proceedings for debarment of counsel under Sec.

1.141(d) of this subpart; and

(4) Other adjudicatory proceedings in which the

complaint instituting the proceeding so provides with the

concurrence of the Assistant Secretary for Administration.

7 C.F.R. § 1.133 Institution of proceedings.

(a) Submission of information concerning apparent

violations. (1) Any interested person desiring to submit

' information regarding an apparent violation of any provi-

sion of a statute listed in § 1.131 or of any regulation,

standard, instruction, or order issued pursuant thereto,

may file the information with the Administrator of the

agency administering the statute involved in accordance

with this section and any applicable statutory

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