# Petition for Writ of Certiorari — Argent Chemical Laboratories, Inc. v. United States

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition for Writ of Certiorari
- **Published:** January 1, 1997
- **Citation:** 520 U.S. 1115

## Text

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No. CE OF THE CLERK

In The

Supreme Court of the United States
October Term, 1996

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ARGENT CHEMICAL LABORATORIES, INC., various

articles of drug identified in Attachment A, which are

located at Argent Chemical Laboratories, Inc., 8515 and
8702 152nd Avenue N.E. Redmond, Washington,

Petitioner,

UNITED STATES OF AMERICA,

Respondent.

* a

Petition For Writ Of Certiorari
To The United States Court Of Appeals
For The Ninth Circuit

+

PETITION FOR WRIT OF CERTIORARI

a

Jon R. ZuLAuF

Attorney for Petitioner

1809 Seventh Avenue

Tower Building - 13th Floor
Seattle, WA 98101

(206) 682-1114

COCKLE LAW BRIEF PRINTING CO., (800) 225-6964
OR CALL COLLECT (402) 342-2831

QUESTIONS PRESENTED FOR REVIEW

1. Did the Ninth Circuit err when it held that the use of
a non-judicial arrest warrant was necessary to further the
regulatory scheme of the Food, Drug and Cosmetic Act?

2. Is the use of a non-judicial arrest warrant improper
when the seizure is not conducted contemporaneously
with an administrative search and there is no showing of
an immediate threat to the public or other exigent circum-
stances?

ii

TABLE OF CONTENTS

Page

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STATUTES INVOLVED IN THIS CASE............. 2
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TABLE OF AUTHORITIES

Page
CASES
Camara v. Municipal Court, 387 U.S. 523 (1967)........ 5
Colonnade Catering Corp. v. United States, 397 US.
ee 2&9, 231, 13
Coolidge v. New Hampshire, 403 U.S. 443 (1971)........ 9
Donovan v. Dewey, 452 U.S. 594 (1981)................ 6
Horton v. California, 496 U.S. 128 (1990) .............. 5
Marshall v. Barlow’s, Inc., 436 U.S. 307 (1978) ......... 5
New York v. Burger, 482 U.S. 691 (1987)............. 6, 7
S & S Pawn Shop, Inc. v. City of Del City, 947 F.2d
I oc wa cuceceees 11, 12
United States v. Articles of Drug Neptone, 569
Se Bae GUE COl, 1983)... ccc cee. 10
United States v. Biswell, 406 U.S. 311
EE eee 4,5, 6, 9, 11, 13
United States ». Device Labeled “Theramatic”, 641
oe 8 a S| 8, 9, 10
Winters v. Board of County Commissioners, 4 F.3d
Nee en caeebewe 11, 12
STATUTES AND RULES
Supplemental Rules for Certain Admiralty and
Maritime Claims, Rule C(3).................2, 3, 4, 9
ne 2
og ke kaw uccunneweiesecec a & Fs a

ee 3

TABLE OF AUTHORITIES - Continued

Page
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26 USA. & SABE) 60 ce vseccaseedeecsecpevesences tues 1

ad _—

OPINIONS BELOW

The opinion of the United States Court of Appeals for
the Ninth Circuit that gives rise to this Petition is
reported at 93 F.3d 572 (9th Cir. 1996). It is reprinted in
Appendix A hereto (“App. A”) at Page A-1.

The Order of the District Court for the Western Dis-
trict of Washington which granted petitioner’s motion to
quash is unpublished and may be cited as No. C94-1120C
(W.D. Wash. Oct. 15, 1994) (Order granting Motion to
Quash Warrant and Return Property). It is reprinted in
Appendix B hereto (“App. B”) at page B-1.

4

JURISDICTION

Petitioner seeks review of the United States Court of
Appeals for the Ninth Circuit’s decision filed on August
16, 1996. In that decision, the Ninth Circuit reversed the
order of the United States District Court for the Western
District of Washington quashing a Warrant for Arrest In
Rem which permitted the seizure from petitioner of var-
ious veterinary drug products. Pursuant to Supreme
Court Rule 13.1, this petition has been filed within 90
days of the entry of judgment.

The jurisdiction of the Court is invoked pursuant to
28 U.S.C. § 1254(1).

STATUTES AND CONSTITUTIONAL PROVISIONS
INVOLVED IN THIS CASE

21 U.S.C. § 334. The text of § 334 is reprinted in Appendix
C hereto (“App. C”) at page C-1.

Supplemental Rules for Certain Admiralty and Maritime
Claims, Rule C. The text of Rule C is reprinted in Appen-
dix D hereto (“App. D”) at page D-1.

The Fourth Amendment to the United States Constitution
provides:

The right of the people to be secure in their
persons, houses, papers, and effects, against
unreasonable searches and seizures, shall not be
violated, and no Warrants shall issue, but upon
probable cause, supported by Oath or affirma-
tion, and particularly describing the place to be
searched, and the persons or things to be seized.

I. STATEMENT OF THE CAsE

Petitioner, Argent Chemical Laboratory (“Argent”),
manufactures veterinary drug products. Agents of the
Food and Drug Administration (“FDA”) inspected Argent
Chemical Laboratory facilities on May 9, 1994. The FDA
cited Argent for certain violations of the Food, Drug and
Cosmetic Act, 21 U.S.C. § 301 et seq. (“the Act”), and
asked that corrections be made. The FDA did not take
any enforcement action at the time of the May 9, 1994
inspection and made no attempt to seize drugs at that
time. The FDA did not order Argent to stop manufactur-
ing drugs, nor did it order Argent to cease selling the
drugs that it had already manufactured.

Argent continued to manufacture and sell its prod-
ucts and made the corrections which the FDA had
requested. Each of the FDA’s concerns were addressed by
the management of Argent and either corrections were
made or explanations were given to the FDA. Throughout
the summer of 1994, the FDA gave Argent no indication
that its efforts failed to bring it in compliance with the
Act.

On July 29, 1994, almost three months after its most
recent inspection, the FDA filed a complaint in the West-
ern District of Washington for the forfeiture of several
categories of veterinary drugs and their constituent mate-
rials in Argent’s possession. The FDA then obtained a
warrant for arrest in rem in order to seize those drugs.
The warrant was not issued by a magistrate, but by
Nealann Shari, a deputy clerk of the District Court.
Argent was not given notice of the complaint, nor of the
warrant for arrest. Then on August 11, 1994, 13 days after
the warrant was issued and 94 days after the FDA’s last
inspection, federal agents entered Argent’s place of busi-
ness and seized over $100,000 worth of chemicals.

The warrant for arrest in rem was issued pursuant to
the Act, 21 U.S.C. § 334(b), which permits the seizure of
articles under the procedure in admiralty provided in
Rule C of the Supplemental Rules for Certain Admiralty
and Maritime Claims (Rule C). Rule C does not require a
showing of probable cause, nor review by a magistrate,
but instead allows a court clerk to issue a warrant of
arrest upon the filing of a complaint.

The district court granted Argent’s motion to quash
the warrant finding that the warrant violated the Fourth
Amendment. The district court noted that although the
Court has carved out an exception to the Fourth Amend-
ment which allows inspections of “closely regulated”
industries, the exception applies only to administrative
inspections. App. B. The district court held that the
exception did not allow the government to “conduct a
particularized search and seizure without first obtaining
an ordinary warrant.” App. B.

SO ETN eon

The government appealed and the Ninth Circuit
reversed. The Circuit Court held that the Colonnade-
Biswell exception which allows warrantless administra-
tive inspections of “closely regulated businesses” also
allows the government to conduct particularized war-
rantless searches for the purpose of seizing evidence.

Il. ARGUMENT

A. The Ninth Circuit Erred When it Found that the
Seizure of Argent’s Property Pursuant to a
Non-Judicial Warrant Was Necessary to Further
the Regulatory Scheme of the Food, Drug &
Cosmetic Act.

DNAS Se

This forfeiture action arose under 21 U.S.C. § 334,
which authorizes the seizure and forfeiture of, among
other things, adulterated drugs. The statute provides that |
“the procedure in cases under this section shall conform,
as nearly as may be, to the procedure in admiralty.” |
§ 334(b).

Rule C of the Supplemental Rules for Certain Admi- '
ralty and Maritime Claims provides that:

a a O

[I]n actions by the United States for forfeitures
for federal statutory violations, the clerk, upon
filing of the complaint, shall forthwith issue a
summons and warrant for the arrest of the ves-
sel or other property without requiring a certi-
fication of exigent circumstances.

It is a fundamental proposition of Fourth Amend-
ment law that “except in certain carefully defined classes
of cases, a search of private property without proper
consent is ‘unreasonable’ unless it has been authorized by
a valid search warrant.” Camara v. Municipal Court, 387
U.S. 523, 529 (1967). A valid search warrant requires a
showing of probable cause and review by a neutral and
impartial magistrate. Horton v. California, 496 U.S. 128, 143
(1990) (Brennan, J., dissenting). Rule C violates funda-
mental Fourth Amendment law because it does not
require a showing of probable cause, nor scrutiny by an
impartial magistrate, and it does not fit within any of the
narrow exceptions to the warrant requirement.

This Court has carved out exceptions to the warrant
requirement for “pervasively regulated businesses” and
for “closely regulated industries long subject to close
supervision and inspection.” Marshall v. Barlow’s, Inc., 436
U.S. 307, 313 (1978). In Colonnade Catering Corp. v. United
States, the Court acknowledged Congress’ “broad author-
ity to fashion standards of reasonableness for searches
and seizures” in the liquor industry “long subject to close
supervision and inspection.” 397 U.S. 72, 77 (1970). Then,
in United States v. Biswell, 406 U.S. 311, 317 (1972), the
Court held that warrantless inspections of a firearms
dealership, conducted pursuant to a statutory inspection
scheme, did not offend the Fourth Amendment.

More recently, the Court has upheld warrantless
inspection schemes involving coal mines, Donovan v.
Dewey, 452 U.S. 594 (1981), and automobile junkyards,
New York v. Burger, 482 U.S. 691 (1987).

In Burger, the Court clarified that warrantless inspec-
tions of pervasively regulated businesses are reasonable
only if three criteria are met. First, there must be a sub-
stantial governmer:t interest that informs the regulatory
scheme. Id. at 702. Second, the warrantless inspections
must be necessary to further the regulatory scheme. Id. at
702-03. And third, the inspection program, in terms of the
certainty and regularity of its application, must provide a
constitutionally adequate substitute for a warrant. Id. at
703.

In the present case, the Ninth Circuit held that the
Colonnade-Biswell exception to the warrant requirement
applied to the Argent seizure. Specifically, the Ninth Cir-
cuit held that the drug-manufacturing industry is so
closely regulated that owners of drug factories have a
lesser expectation of privacy which must give way to the
government’s substantial interest in protecting the public
from adulterated drugs. Therefore, the Ninth Circuit rea-
soned, the in rem arrest procedure of Supplemental Rule
C does not violate any Fourth Amendment protection
afforded the owners of a veterinary drug manufacturing
company.

The Ninth Circuit’s analysis, however, failed to ade-
quately consider the criteria set forth in Burger, 482 U.S.
at 702-03, and failed to properly limit the administrative
inspection exception.

ee

The court in Burger, recognized that there must be
limits on administrative inspections. A procedure that
circumvents the Fourth Amendment warrant requirement
should be permitted only when it is “necessary” to fur-
ther a regulatory scheme. Here, there was no showing
that a non-judicial arrest warrant procedure wa* neces-
sary to further the regulatory scheme. There was no
showing that the government's interest would have been
impaired by obtaining a warrant from a judge or magis-
trate. There was no showing of an imminent danger to
the public that would justify using a non-judicial warrant
of arrest.

The provisions of § 334 which permit warrants of
arrest issued by court clerks instead of judicially scruti-
nized seizure warrants based on probable cause are
unnecessary to the regulatory scheme. Under the criteria
of the Burger decision, the seizure provisions of Rule C
violate the Fourth Amendment because they are unneces-
sary.

The Ninth Circuit’s analysis failed to distinguish
between regulatory inspections and later, particularized
seizures of property at the same location. While the regu-
latory inspections may have been necessary to further the
regulatory scheme, the non-judicial warrant procedure
used in the later particularized seizure of property was
not necessary. There was no showing that the Rule C non-
judicial warrant provisions were important or necessary
to the regulatory scheme.

In the present case, the FDA waited 94 days after the
last regulatory inspection before taking any action to
seize Argent’s property. There was no showing that the

FDA would have been hindered in its seizure of Argent’s
property by forcing the agency to obtain a traditional
seizure warrant. The FDA should have obtained a war-
rant from a neutral magistrate upon a showing of proba-
ble cause before seizing Argent’s property on August 11,
1994.

B. The Ninth Circuit’s Decision in the Argent
Case Directly Conflicts With an Earlier Ninth
Circuit Decision, a Prior District Court Opin-
ion, and the Tenth Circuit’s Holding in S & S
Pawn Shop, Inc. v. City of Del City.

An earlier Ninth Circuit decision addressed the issue
of whether a court clerk may, consistent with the Fourth
Amendment, issue a warrant for an arrest in rem under
§ 334. In United States v. Device, Labeled “Theramatic”, 641
F.2d 1289 (9th Cir. 1981), federal agents entered a doctor’s
office and seized a diathermy machine alleged to be
misbranded. The agents acted on the authority of an
arrest warrant issued by the clerk of the court. The Ninth
Circuit concluded:

We hold that absent exigent circumstances,
entrance into homes and offices to seize items
alleged to violate the Food, Drug, and Cosmetic
Act must comply with the basic requirements of
the Fourth Amendment: the verified complaint
on which the warrant authorizing seizure is
based must provide probable cause to believe
that the article to be seized violates the act, and
the complaint must be scrutinized by a
detached, independent official, empowered to
decide whether probable cause does exist,
before the warrant is issued.

Id. at 1295. In so holding, the court explained that because
“the government has a specific target in mind,” the cases
involving random inspections to enforce statutory stan-
dards did not apply. Id. at 1294. Theramatic did not
address the question of whether the general inspection
scheme of the Act violated the Fourth Amendment, the
constitutionality of which would be subject to analysis
under Colonnade-Biswell. Instead, Theramatic addressed
whether in rem arrest warrants may constitutionally be
issued pursuant to § 334 and Supplemental Rule C.
Although a well-defined scheme for inspecting per-
vasively regulated businesses may survive Fourth
Amendment scrutiny, the protection against unreasonable
searches and seizures may nevertheless prevent govern-
ment agents from returning to conduct a particularized
search and seizure without first obtaining an ordinary
warrant. See Coolidge v. New Hampshire, 403 U.S. 443,
471-72 (1971) (holding “plain view” exception did not
apply to seizure of car when police knew of car’s loca-
tion, intended to seize the car, and had ample oppor-
tunity to obtain warrant).

The agents in this case had previously conducted
administrative inspections pursuant to § 374(a) of the
Act. The constitutionality of these inspections is not an
issue here. Based on their conclusion that Argent was in
violation of the Act, the agents obtained the in rem arrest
warrant to search a particular business to seize particular,
identified chemicals and drugs. The arrest warrant was
issued, pursuant to § 334 and Supplemental Rule C, by a
deputy clerk who did not review the government's alle-
gations to determine if there was cause to seize the items.

10

This is precisely what the Ninth Circuit forbade in Thera-
matic.

Other courts have made the distinction between rou-
tine administrative inspections and seizures of particular,
identified items. In United Stxtes v. Articles of Drug .. .
Neptone, 569 F. Supp. 1182 (N.D. Cal. 1983) the court
found that an FDA seizure violated the Fourth Amend-
ment when it seized drugs without a warrant:

Whether Aquaculture reasonably expected the
Hirschberg facilities to be subject to regular gov-
ernment inspection is irrelevant here, as the act
in question was a premeditated seizure of speci-
fied items . . . it is well settled that where it is
practicable to obtain a warrant, the government
must do so. Indeed, where the government
knows in advance the location and description
of evidence and intends to seize it, as was the
case here, the requirement of a warrant imposes
no constitutionally recognizable inconvenience
.. . » Here there is no evidence of any excep-
tional situation that would justify a warrantless
seizure. The government does not contend that
it was responding to an emergency or that it was
in hot pursuit. There is no evidence that the
goods were being destroyed or were about to be
removed from the premises. The government
offers no evidence that it was impracticable to
obtain a warrant. (citations omitted)

The court in Neptone recognized that portions of an
administrative inspection scheme may be unconstitu-
tional if they are unnecessary to further the regulatory
scheme. Warrantless searches to seize particularized
pieces of evidence, absent a showing of exigent circum-
stances, are unnecessary.

we ~

11

The Ninth Circuit’s decision in Argent also conflicts
with the Tenth Circuit holding in S & S Pawn Shop, Inc. v.
City of Del City, 947 F.2d 432 (10th Cir. 1991). In that case,
the court found that the pawn shop business was closely
regulated justifying warrantless administrative inspec-
tions. The court found, however, that some searches and
seizures of S & S Pawn may have been conducted pur-
suant to “direct criminal suspicion,” thus necessitating a
warrant:

As evidenced in the depositions, appellant pre-
sents material facts demonstrating that the
inspections of appellant’s business premises
were conducted not as part of a pre-planned and _
dispassionate administrative procedure but
instead pursuant to direct criminal suspicion.
Such a search gives cause for grave constitu-
tional concern. A proper administrative search
is conducted on neutral criteria to restrain the
discretion of the officer in charge of the search.

The Tenth Circuit does not permit warrantless
searches of highly regulated businesses when the search
is being conducted for a particular item as evidence of a
crime. In Winters v. Board of County Commissioners, 4 F.3d
848 (9th Cir. 1993), the police had entered a pawnshop
solely for the purpose of seizing evidence of a crime that
the police knew was in possession of the pawnshop. The
Tenth Circuit found that pawnshops are “closely regu-
lated” industries under Oklahoma law for the purposes
of the Colonnade-Biswell exception. Id. at 852 (citing S.S.
Pawn, 947 F.2d at 436-39). However, the court did not
allow the government to bootstrap the police’s entrance
into the pawnshop to seize particular property onto the

12

government’s ability to administratively inspect the
pawnshop:

If we were to allow an officer under the guise of
the administrative statute to seize evidence of
criminal activity without a warrant when the
officer has a particularized suspicion regarding
that evidence, we would eradicate the Fourth
Amendment protections enjoyed by the pawn-
shop.

Although we upheld the constitutionality of
the Oklahoma statutes in S & S Pawn, we cau-
tioned that the execution of an administrative
search pursuant to direct criminal suspicion
raises grave constitutional concerns. S & S Pawn
947 F.2d at 441. We noted that the exigent cir-
cumstances allowing a warrantless administra-
tive search evaporate when the police intend to
seize particular criminal evidence. “Once it is
discovered that a pawnshop possesses stolen
property, ‘spot’ searches are no longer neces-
sary. Moreover, after the pawn tickets are turned
over to the enforcing officer, ‘surprise’ no longer
appears to justify the necessity of a warrantless
search.” Id. at 441 n.7. Simply put, when a law
enforcement officer intends to seize a particular
piece of criminal evidence from the premises of
a pawnshop, the seizure may not be substanti-
ated by relying on the pretense of an adminis-
trative search coupled with the plain view
doctrine. In such a situation, the officer must
obtain a warrant. Thus we reverse the district
court and find there was a seizure in violation of
Ms. Winter’s Fourth Amendment rights.

Id. at 854-55.

The reasoning of the Tenth Circuit in S & S Pawn
and Winters is in direct conflict with the Ninth Circuit’s

OCT see errs ene -

13

decision in Argent when applying the Colonnade-Biswell
exception. The conflict is irreconcilable and certiorari is
appropriate.

Ill. CONCLUSION

The Court should accept review of the Ninth Circuit
decision both because the lower court misapplied the
Colonnade-Biswell exception to the warrant requirement
and because the decision conflicts with decisions within
the Ninth Circuit and also with the Tenth Circuit’s appli-
cation of the Colonnade-Biswell exception when the gov-
ernment enters a “closely regulated” business not to
inspect, but for the sole purpose of seizing property.

Respectfully submitted this 13th day of November,
1996.

FiNEGOLD & ZULAUF

Jon R. ZuLaurF
Attorney for Argent Chemical
Laboratories, Inc.

In The

Supreme Court of the United States
October Term, 1996

ARGENT CHEMICAL LABORATORIES, INC., various
articles of drug identified in Attachment A, which are
located at Argent Chemical Laboratories, Inc., 8515
and 8702 152nd Avenue N.E. Redmond, Washington,

Petitioner,
V.

UNITED STATES OF AMERICA,
Respondent.

Petition For Writ Of Certiorari
To The United States Court Of Appeals
For The Ninth Circuit

APPENDIX

A-l

APPENDIX A
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

Unrrep States OF AMERICA,

Plaintiff-Appellant,
7 No. 95-35167
ARGENT CHEMICAL LasoraTories, INC. D.C. No.

various articles of drug identified
in Attachment A, which are
located at Argent Chemical
Laboratories, Inc., 8515 and 8702
152nd Avenue NE, Redmond,
Washington,

Defendant-Appellee.

CV-94-01120-JCC

OPINION

Ne ee eee ee ee ee ee eee ee ee ee”

Appeal from the United States District Court
for the Western District of Washington
John C. Coughenour, District Judge, Presiding

Argued and Submitted
January 9, 1996 — Seattle, Washington

Filed August 16, 1996

Before: James R. Browning, Eugene A. Wright and
William C. Canby, Jr., Circuit Judges

Opinion by Judge Canby

A-2

COUNSEL

Jacob M. Lewis, United States Department of Justice,
Washington, D.C., for the plaintiff-appellant.

John R. Zulauf, Finegold, Zulauf & Engelhard, Seat-
tle, Washington, for the defendant-appellee.

OPINION

CANBY, Circuit Judge:

Under procedures authorized by Congress, the Food
and Drug Administration (“FDA”) seized allegedly adul-
terated products from the premises of a regulated veter-
inary drug manufacturer, without obtaining a warrant
from a judicial officer issued upon a finding of probable
cause. The question before us is whether that seizure
violated the Fourth Amendment. We concluded that it
did not, and we reverse the judgment of the distric: court.

I. The Factual Background

Argent Chemical Laboratories manufactures and
repackages veterinary drugs. FDA agents inspected
Argent several times between the summer of 1993 and
May 1994 to ensure compliance with the Food, Drug, and
Cosmetic Act, 21 U.S.C. § 301 et seq. (“Act”). The FDA
cited Argent for certain deficiencies. Several months after
the last inspection, the FDA agents secured from the

A-3

Deputy Clerk of the District Court, without the interven-
tion of a judicial officer or a showing of probable cause,
an in rem arrest warrant for various veterinary drugs
alleged to violate the Act. FDA agents and United States
Marshals then seized over $100,000 worth of veterinary
drugs from Argent’s premises.

This condemnation action followed. Argent appeared
as claimant and contested the constitutionality of the
seizure. The district court held that the seizure violated
the Fourth Amendment; it accordingly granted Argent’s
motion to quash the in rem arrest warrant and ordered the
government to return the property. The government
appealed, and the district court stayed its order pending
the appeal.

II. The Statutory Scheme of Seizure

The warrant in this case was issued in accordance
with the Act. Under the Act, an article “proceeded
against shall be liable to seizure by process pursuant to
the libel, and the procedures in cases under this section
shall conform, as nearly as may be, to the procedure in
admiralty. ...” 21 U.S.C. § 334(b). Under the Supplemen-
tal Rules for Certain Admiralty and Maritime Claims
(“Supplemental Rules”), an in rem action begins with a
complaint that must “be verified on oath or solemn affir-
mation” and that must “describe with reasonable partic-
ularity the property that is the subject of the action.”
Supplemental Rule C(2). Upon filing of the complaint, the

clerk issues a warrant:

A-4

Except in actions by the United States for forfei-
tures for federal statutory violations, the veri-
fied complaint and any supporting papers shall
be reviewed by the court and, if the conditions
for an action in rem appear to exist, an order so
stating and authorizing a warrant for the arrest
of the vessel or other property that is the subject
of the action shall issue and be delivered to the
clerk who shall prepare the warrant.

In actions by the United States for forfeitures for
federal statutory violations, the clerk, upon filing of
the complaint, shall forthwith issue a summons and
warrant for the arrest of the vessel or other property.

Supplemental Rule C(3) (emphasis added). Thus, because
this was an action by the United States for a forfeiture for
federal statutory violations, FDA agents were able to
obtain a warrant without review by a judicial officer or a
finding of probable cause.

Ill. The Fourth Amendment and the Colonnade-
Biswell Exception

Argent argues that, although the drugs were seized
pursuant to a warrant issued in accordance with the Act,
the seizure violated the Fourth Amendment’s prohibition
of unreasonable searches and seizures and its require-
ment that warrants issue upon probable cause. We con-
clude, however, that Argent’s argument is defeated by
the nature of its business and the regulation to which it is
subject.

A-5

The Fourth Amendment applies to commercial prem-
ises as well as to private homes, See v. City of Seattle, 387
U.S. 541, 546 (1967), but under the so-called Colonnade-
Biswell exception, warrantless searches and seizures on
commercial property used in “closely regulated” indus-
tries are constitutionally permissible. Colonnade Catering
Corp. v. United States, 397 U.S. 72 (1970); United States v.
Biswell, 406 U.S. 311 (1972). Persons engaging in per-
vasively regulated industries have a diminished expecta-
tion of privacy. New York v. Burger, 482 U.S. 691, 702
(1987); Biswell, 406 U.S. at 316. With regard to such indus-
tries, “Congress has broad authority to fashion standards
of reasonableness for searches and seizures.” Colonnade,
397 U.S. at 77. Thus in Colonnade and Biswell, the Court
held that there was no constitutional violation when the
businesses of dispensing liquor and selling firearms,
respectively, were subjected to inspections and seizures
without a warrant issued by a judicial officer upon proba-
ble cause.

Argent asserts that it is not subject to the Colonnade-
Biswell exception for two reasons: first, its veterinary
drug business is not the kind of industry that is subject to
the Colonnade-Biswell exception; and second, the Colon-
nade-Biswell exception does not extend to a separate and
particularized seizure of misbranded or adulterated
goods. We reject both contentions.

IV. Manufacture of Veterinary Drugs as a Closely Reg-
ulated Industry

In New York v. Burger, 482 U.S. at 702-03, the Supreme
Court set forth the standards for determining when the

A-6

Colonnade-Biswell exception applies.! A warrantless
inspection will be deemed reasonable only if the business
is closely regulated and if three criteria are met:

First, there must be a “substantial” govern-
ment interest that informs the regulatory
scheme pursuant to which the inspection is
made. .

Second, the warrantless inspections must be
“necessary to further [the] regulatory
scheme.” .. .

Finally, “the statute’s inspection program, in
terms of the certainty and regularity of its appli-
cation, [must] provid[e] a constitutionally ade-
quate substitute for a warrant.”

Burger, 482 U.S. at 702-03 (quoting Donovan v. Dewey, 452
U.S. 594, 600, 602-03 (1981)). We conclude that all of these
standards are met in this case.

As a threshold matter, the veterinary drug industry is
“closely regulated.” See generally 21 U.S.C. §§ 301 - 392; 21
C.F.R. Pts. 200-599. The Food, Drug, and Cosmetic Act
prohibits the adulteration or misbranding of any drug, 21
U.S.C. § 331(b), whether that drug is intended for use by
either humans or animals, 21 U.S.C. § 321(g)(1)(B).
“[V]irtually every phase of the drug industry is heavily
regulated, from packaging, labeling, and certification of
expiration dates, to prior FDA approval before new drugs

1 Although Burger pertained only to a search, the Colonnade-
Biswell exception applies to searches and seizures. See Colonnade, 397
U.S. at 77 (warrantless search and seizure of liquor held
constitutiona!); Biswell, 406 U.S. at 317 (warrantless search and
seizure of firearms held constitutional); see also infra part III.

A-7

can be marketed.” United States v. Jamieson-McKames Phar-
maceuticals, Inc., 651 F.2d 532, 537 (8th Cir. 1981) (foot-
notes omitted), cert. denied, 455 U.S. 1016 (1982); see e.g.,
21 U.S.C. § 351(a) (regulating manufacture), § 351(b) (reg-
ulating strength, quality, and purity), § 352(a), (b), (f). (g),
(h), (p), regulating packaging and labeling); § 355 (new
drug approvals), § 360b (regulating new animal drug
approvals). Regulations implementing the act are quite
extensive. See generally 21 C.F.R. Pts. 200-599. For exam-
ple, good manufacturing practices for the preparation of
human and animal drugs are set forth in detail. See 21
C.F.R. Pts. 210, 211.2 The veterinary drug industry is
certainly regulated as extensively as the vehicle disman-
tling industry, which the Supreme Court has held to be
“closely regulated.” See Burger, 482 U.S. 703-04.

Although duration of a particular regulatory scheme
has “some relevancy” in determining whether an indus-
try is closely regulated, Burger, 482 U.S. at 705, “it is the
pervasiveness and regularity of the federal regulation
that ultimately determines whether a warrant is neces-
sary.” Donovan, 452 U.S. at 606. The pervasiveness and
regularity of the current regulatory scheme is sufficient to

2 These regulations include personnel qualifications and
responsibilities, 21 C.F.R. §§ 211.25, 211.28; buildings and
facilities specifications, 21 C.F.R. §§ 211.42-211.58; equipment
specifications, 21 C.F.R. §§ 211.63-211.72; production and
process controls, 21 C.F.R. §§ 211.100-211.115; packaging and
labeling controls, 21 C.F.R. §§ 211.122-211.137; holding and
distribution procedures, 21 C.F.R. §§ 211.142, 211.150;
laboratory controls, 21 C.F.R. §§ 211.160-211.176; and
requirements for recording and reporting, 21 C.F.R.
§§ 211.180-211.198, to name but a few.

A-8

make it “closely regulated” under Burger wholly apart
from any consideration of duration.

FDA regulation of Argent’s industry also meets the
three enumerated criteria of Burger. First, there is “a
‘substantial’ government interest that informs the regula-
tory scheme pursuant to which the inspection is made.”
Burger, 482 U.S. at 702. Argent argues that in some
respects animal drug provisions are less stringent than
human drug provisions, compare 21 U.S.C. § 355 (new
drugs) with 21 U.S.C. § 360b (new animal drugs), and that
regulation of animal drugs is primarily motivated by
economic considerations rather than human safety, see 1
James T. O’Reilly, Food and Drug Administration § 16.01, at
16-3 & n.9 (2d ed. 1995). Neither argument suggests that
the government lacks a substantial interest in ensuring
the safety and effectiveness of animal drugs. Congress
has seen fit, either for human safety or for economic
reasons, to regulate animal drugs to ensure their safety
and effectiveness. Whether the interest is human health,
economic health, or both, we conclude that it is substan-
tial.

Second, “the warrantless inspections [are] ‘necessary
to further [the] regulatory scheme.’ ” Burger, 482 U.S. at
702 (quoting Donovan, 452 U.S. at 600). Unannounced
inspections have a deterrent effect; forcing inspectors to
obtain a warrant before inspection might frustrate the
purpose of the Act by alerting owners to inspections. See
id. at 702-03; Biswell, 406 U.S. at 316. Moreover, this court

3 We note, however, that the original 1906 Food and Drugs
Act provided for regulation of animal drugs. Act of June 30,
1906, ch. 3915, § 6, 34 Stat. 769.

A-9

has recognized the “need for swift governmental action
to remove misbranded products from the stream of com-
merce.” United States v. An Article of Device “Theramatic”,
715 F.2d 1339, 1343 (9th Cir. 1983) (“Theramatic II’), cert.
denied sub nom. Cloward v. United States, 465 U.S. 1025
(1984). Thus, warrantless searches and seizures are neces-
sary to further the regulatory scheme that ensures the
integrity of veterinary drugs.

Finally, the regulatory scheme, ” ‘in terms of the cer-
tainty and regularity of its application, [provides] a con-
stitutionally adequate substitute for a warrant,’ ” thereby
satisfying the third Burger requirement. Burger, 482 U.S. at
703 (quoting Donovan, 452 U.S. at 603). “[T]he regulatory
statute must perform the two basic functions of a war-
rant: it must advise the owner of the commercial premises
that the search is being made pursuant to the law and has
a properly defined scope, and it must limit the discretion
of the inspecting officers.” Id. Taken as a whole, the Act,
the accompanying regulations, and the Supplemental
Rules for Certain Admiralty and Maritime Claims pro-
vide a constitutionally adequate substitute for a warrant.
Inspections are conducted with notice furnished at the
time, and their scope is limite’ by statute. 21 U.S.C.
§ 374(a)(1). Seizures are limited to drugs that are adulter-
ated or misbranded, 21 U.S.C. § 334(a)(1), the articles to
be seized must be described “with reasonable partic-
ularity,” Supplemental Rules C(2), and the government's
complaint must be “verified on oath or solemn affirma-
tion,” id. Moreover, in most cases, the seizure is subject to
the approval of one of the Food and Drug Administra-
tion’s district offices, the appropriate office (or “center”)
in the Food and Drug Administration headquarters, the

A-10

Food and Drug Administration’s Office of Enforcement,
the Office of the Chief Counsel, and the Department of
Justice. See FDA Regulatory Procedures Manual, ch. 6, at
173-85 (Aug. 1995).4

We conclude, therefore, that Argent’s operation, as
regulated by the FDA, falls within the Colonnade-Biswell
exception to the Fourth Amendment’s warrant require-
ment.

V. The Particularized Seizure and the Warrant
Requirement of the Theramatic Case

Argent next contends that, even if it is a “closely
regulated” industry for purposes of the Colonnade-Biswell
exception, that exception does not apply to the seizure in
this case.

To the extent that Argent’s argument suggests that
the Colonnade-Biswell exception applies only to inspec-
tions and not to seizures, the argument is untenable. It is
true that Burger discussed its criteria for “closely regu-
lated” industries in terms of “inspections,” but it also
approved the use of evidence seized in the course of the
inspection. 482 U.S. at 716. Moreover, both Colonnade and
Biswell involved seizures of contraband discovered dur-
ing the unwarranted inspections. Biswell held that,
because the unwarranted inspection was constitutionally
permissible. “[t]he seizure of respondent’s sawed-off

4 On occasion, in the case of so-called “direct reference
seizures,” headquarters review is skipped. See FDA Regulatory
Procedures Manual, ch. 6, at 176.

Eo

A-11

rifles was not unreasonable under the Fourth Amend-
ment.” 406 U.S. at 317. Thus, Colonnade-Biswell extends to
seizure without warrant of what may be inspected with-
out warrant, when Congress so authorizes.

The argument that Argent most vigorously asserts,
and the one that was accepted by the district court, is
based on our decision in United States v. Device Labeled
“Theramatic”, 641 F.2d 1289 (9th Cir. 1981) (“Theramatic
I”), In Theramatic I, we held that the Fourth Amendment
was violated by the FDA’s seizure from a physician’s
office of an allegedly misbranded medical device pur-
suant to a warrant issued under the Supplemental Rules.
Id. at 1295. We emphasized that the physician was enti-
tled to the protection of the Fourth Amendment in his
office just as he was in his home. Id. at 1292. We recog-
nized that some administrative searches could be con-
ducted on the strength of a warrant issued on less than
probable cause, but the government in Theramatic I was
not conducting random inspections to enforce adminis-
trative standards; it was “searching a particular physi-
cian’s office to seize a particular, identified device.” Id. at
1294. Finally, we said that the Colonnade-Biswell exception
to the warrant requirement did not apply because the
“search at issue here was not part of any statutory pro-
gram to inspect physicians’ offices.” Id. at 1295.

We do not draw from Theramatic I the same lessons
that Argent and the district court did. The problem with
the seizure in Theramatic I was that it was effectuated by
an impermissible invasion of the physician’s right of pri-
vacy. That is why we were careful in Theramatic I to point
out that the case involved not only a seizure, “but a
paradigmatic search - a physical intrusion by the U.S.

A-12

Marshal into [the physician's] office.” Id. at 1291. We also
stated:

It is one thing to seize without a warrant prop-
erty resting in an open area or seizable by levy
without an intrusion into privacy, and it is quite
another thing to effect a warrantless seizure of
property, even that owned by a corporation,
situated on private premises to which access is not
otherwise available for the seizing officer.

Id. at 1292 (quoting G.M. Leasing Corp. v. United States, 429

U.S. 338, 354 (1977)) (emphasis added). The Colonnade-

Biswell exception did not apply because it is based largely

on the diminished expectation of privacy in a closely- |
regulated industry, see Burger, 482 U.S. at 700, and the |
physician in Theramatic I was not closely regulated by the |
FDA.

The district court, however, accepted Argent’s inter-
pretation of Theramatic I, concluding that “[aJlthough a
well-defined scheme for inspecting pervasively regulated
businesses may survive Fourth Amendment scrutiny, the
protection against unreasonable searches and seizures
may nevertheless prevent government agents from
returning to conduct a particularized search and seizure
without first obtaining an ordinary warrant.” The District |
Court held that Theramatic I forbade agents from search- |
ing “a particular business to seize particular, identified |
chemicals and drugs.”

Theramatic I’s reference to a particularized search,
however, was made to point out that the search con-
ducted there was not an administrative search similar to
those designed to insure sanitary housing conditions, see

A-13

Camara v. Municipal Court, 387 U.S. 523 (1967), or work-
place safety, see Marshall v. Barlow’s, Inc., 436 U.S. 307
(1978); that was not what the FDA was doing. But a
wholly separate point (which we thought was even
clearer) was that the physician was not “closely regu-
lated” by the FDA and therefore was not subject to the
Colonnade-Biswell exception. Theramatic I, 641 F.2d at 1295.

Thus it is the invasion of privacy, not the partic-
ularity of the seizure, that is the relevant difference
between Argent’s case and Theramatic I for purposes of
the Colonnade-Biswell exception. Argent, being closely
regulated by the FDA, has a diminished expectation of
privacy that was not violated by the seizure. We attach no
significance to the fact that the FDA “returned” to exe-
cute its in rem warrant some time after its last inspection.
If a random, unannounced inspection does not violate
Argent’s Fourth Amendment right of privacy, we see no
reason why the unannounced execution of a warrant
under the Supplemental Rules would do so. The seizure
is from the premises of a closely regulated manufacturer
and is conducted within the regulatory scheme in the
manner Congress has authorized. There is no need to
brigade the seizure with an inspection in order to legiti-
mize it; Argent’s expectation of privacy has not been
violated.

VI. Conclusion

Under the Colonnade-Biswell exception to the Fourth
Amendment, Argent had a “reduced expectation of pri-
vacy.” Burger, 482 U.S. at 702. As a consequence, the
seizure of Argent’s drugs from its premises pursuant to a

A-14

warrant issued in accordance with 21 U.S.C. § 334 and
Supplemental Rule C did not violate the Fourth Amend-
ment.

REVERSED.

B-1

APPENDIX B

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF WASHINGTON

AT SEATTLE
UNITED STATES, ) CASE NO. C€94-1120C
Plaintiff, ORDER ON MOTION
i ) TO QUASH WARRANT
) AND RETURN PROPERTY
oa tees wie: i
: )
Defendant. )
)

This matter comes before the Court on the motion of
claimant Argent Chemicals Laboratories, Inc., for an
order quashing the in rem arrest warrant and directing
the government to return the seized articles.

I. BACKGROUND

Agents of the Food and Drug Administration
inspected Argent’s facilities several times in the summer
and fall of 1993, and in May of 1994. The final FDA
inspection occurred on May 9, 1994. The FDA cited
Argent for certain deficiencies and requested that correc-
tions be made. Argent states that it then made the correc-
tions as requested.

On August 11, 1994, FDA agents and U.S. Marshals
seized various drugs and chemicals from Argent, acting
on the authority of an arrest warrant signed by Nealann
Shari, Deputy Clerk of the District Court. There are no

B-2

probable cause determination or judicial review of any
kind prior to the issuance of the warrant.

Il. ANALYSIS

This forfeiture action arises under 21 U.S.C. § 334,
which authorizes the seizure and forfeiture of, among
others things, adulterated drugs. The statute provides
that “the procedure in cases under this section shall con-

form, as nearly as may be, to the procedure in admiralty.”
Id.

Rule C of the Supplemental Rules for Certain Admi-
ralty and Maritime Claims provides that

[iJn actions by the United States for forfeitures
for federal statutory violations, the clerk, upon
filing of the complaint, shall forthwith issue a
summons and warrant for the arrest of the ves-
sel or other property without requiring a certi-
fication of exigent circumstances.

Argent argues that the search and seizure of its prop-
erty pursuant to Rule C violated the Fourth Amendment,
because the warrant was not subject to a probable-cause
determination by a district judge. |

A

The Fourth Amendment prohibits “unreasonable
searches and seizures.” Warrantless searches of private
property, “except in certain carefully defined classes of
cases,” are unreasonable. Camara v. Municipal Court, 387

ee eT TT |

B-3

U.S. 523, 87 S. Ct. 1727, 1731(1967). Because “[t]he busi-
nessman, like the occupant of a residence, has a constitu-
tional right to go about his business free from
unreasonable official entries upon his private commercial
property,” See v. City of Seattle, 387 U.S. 541, 87 S. Ct. 1737,
1739 (1967), the warrant clause “protects commercial
buildings as well as private homes,” Marshall v. Barlow's
Inc., 436 U.S. 307, 98 S. Ct. 1816, 1819 (1978).

The Supreme Court has carved out exceptions to the
warrant requirement for “pervasively regulated busi-
nesses” and for “closely regulated industries long subject
to close supervision and inspection.” Barlow's, 98 S. Ct. at
1820-21 (citations and internal quotations omitted). In
Colonnade Catering Corp. v. United States, 397 U.S. 72, 90 S.
Ct. 774, 777 (1970), the Court acknowledged Congress’
“broad authority to fashion standards of reasonableness
for searches and seizures” in the liquor industry, “long
subject to close supervision and inspection.” Then, in
United States v. Biswell, 406 U.S. 311, 92 S. Ct. 1593 (1972),
the Court held that warrantless inspections of a firearms
dealership, conducted pursuant to a statutory inspection
scheme, did not offend the Fourth Amendment. But the
Court has maintained that these cases are exceptions to
the general rule,

represent[ing] responses to relatively unique cir-
cumstances. Certain industries have such a his-
tory of government oversight that no reasonable
expectation of privacy could exist for a propri-
etor over the stock of such an enterprise. Liquor
(Colonnade) and firearms (Biswell) are industries
of this type; when an entrepreneur embarks
upon such a business, he has voluntarily chosen

B-4

to subject himself to a full arsenal of govern-
mental regulation.

Barlow's, 98 S. Ct. at 1821 (citations omitted). The Court
went on to say that “[t]he element that distinguishes
these enterprises from ordinary businesses is a long tradi-
tion of close government supervision, of which any per-
son who chooses to enter such a business must already be
aware.” Id.

More recently, the Court has upheld warrantless
inspection schemes involving coal mines, Donovan uv.
Dewey, 452 U.S. 594, 101 S. Ct. 2534 (1981), and auto-
mobile junkyards, New York v. Burger, 482 U.S. 691, 107 S.
Ct. 2636 (1987). In Burger, the Court clarified that war-
rantless inspections of pervasively regulated businesses
are reasonable only if three criteria are met. First, there
must be a substantial government interest that informs
the regulatory scheme. Burger, 107 S. Ct. at 2644. Second,
the warrantless inspections must be necessary to further
the regulatory scheme. Id. And third, the inspection pro-
gram, in terms of the certainty and regularity of its appli-
cation, must provide a constitutionally adequate
substitute for a warrant. Id.

The government argues that the Colonnade-Biswell
exception to the warrant requirement applies here. Speci-
fically, the government urges that the drug-manufactur-
ing industry is so closely regulated that owners of drug
factories have a lesser expectation of privacy which must
give way to the government's substantial interest in pro-
tecting the public from adulterated drugs. Therefore, the

B-5

government reasons, the in rem arrest procedure of Sup-
plemertal Rule C does not violate any Fourth Amend-
ment protection afforded the owners of a drug factory.

The government relies heavily on the Eighth Circuit's
decision in United States v. Jamieson-McKames Pharmaceuti-
cals, Inc., 651 F.2d 532 (8th Cir. 1981), cert. denied, 445 US.
1016 (1982). In Jamieson-McKames the court held that the
warrantless inspection procedure of the Food, Drug, and
Cosmetic Act, set out at 21 U.S.C. § 374, does not vioiate
the Fourth Amendment because it fails within the Colon-
nade-Biswell exception. The government also cites Found-
ing Church of Scientology v. United States, 409 F.2d 1146
(D.C. Cir.), cert. denied, 396 U.S. 963 (1969), which held
that the procedure in admiralty, employed to seize
E-meters from the Church of Scientology, did not violate
the Fourth Amendment.!

Contrary to the government's assertion, neither of
these cases is directly on point. Jamieson-McKames stands
for the proposition that § 374, the inspection provision of
the FD&C Act, does not offend the Fourth Amendment.
Jamieson-McKames, 651 F.2d at 538 (holding that “inspec-
tions authorized by § 374 are ‘reasonable’ and therefore
not inconsistent with the Fourth Amendment”). The case
does not address § 334, the provision related to arrests in
rem, except in the context of the applicable probable-
cause standard. Id. at 651 F.2d at 540-41 & n.17. Although

1 The government also cites United States v. Articles of
Hazardous Substance, 588 F.2d 39 (4th Cir. 1978). That case is
inapposite because it involved commercial premises open to the
public, and therefore presented no invasion of privacy. Id. at 43
n.1.

B-6

the agents in Jamieson-McKames obtained the in rem arrest
warrants pursuant to Rule C, see id. at 540 & n.17, it
appears that defendants challenged the seizures only on
the basis that “the application for the warrant for inspec-
tion did not comply with traditional probable-cause stan-
dards.” Id.

Similarly, in Founding Church of Scientology, the court
did not specifically reach the question of whether an in
rem arrest warrant issued by a court clerk would meet
Fourth Amendment standards, because there, “[t]he libel
was subject to scrutiny by a United States District Judge,
and it was only after his review and by court order that
the warrant issued.” Founding Church of Scientology, 409
F.2d at 1150. The court’s other statements to the effect
that the Fourth Amendment did not necessarily require a
“showing of probable cause before a magistrate” in the
contest of civil attachments under the rules of admiralty
is dicta. Id.

Cc

The Ninth Circuit, on the other hand, has specifically
addressed the issue of whether a court clerk may, consis-
tent with the Fourth Amendment, issue a warrant for an
arrest in rem under § 334. In United States v. Device, Labeled
“Theramatic”, 641 F.2d 1289 (9th Cir. 1981), federal agents
entered a doctor’s office and seized a diathermy machine
alleged to be misbranded. The agents acted on the
authority of an arrest warrant issued by the clerk of the
court. The Ninth Circuit concluded:

We hold that absent exigent circumstances,
entrance into homes and offices to seize items

B-7

alleged to violate the Food, Drug, and Cosmetic
Act must comply with the basic requirements of
the Fourth Amendment: the verified complaint
on which the warrant authorizing seizure is
based must provide probable cause to believe
that the article to be seized violates the act, and
the complaint must be scrutinized by a
detached, independent official, empowered to
decide whether probable cause does exist,
before the warrant is issued.

Id. at 1295. In so holding, the court explained that because
“the government had a specific target in mind,” the cases
involving random inspections to enforce statutory stan-
dards did not apply. Id. at 1294 (citing Barlow’s 98 S. Ct.
1816, and Camera, 87 S. Ct. 1727). The court also rejected
the argument that the search fell within the Colonnade-
Biswell exception because “the search at issue here was
not part of any statutory program to inspect physicians’
offices —- the same seizure procedure could have been
used against misbranded devices no matter where they
were found.” Id. at 1295.

Thus, there is an important distinction between Ther-
amatic and the Colonnade-Biswell line of cases. Theramatic
does not address the question of whether the general
inspection scheme of § 374 violates the Fourth Amend-
meit, the constitutionality of which would obviously be
subject to analysis under Colonnade-Biswell. See Jamieson-
McKames. Theramatic does, however, directly address
whether in rem arrest warrants may constitutionally be
issued pursuant to § 334 and Supplemental Rule C.
Although a well-defined scheme for inspecting per-
vasively regulated businesses may survive Fourth
Amendment scrutiny, the protection against unreasonable

B-8

searches and seizures may nevertheless prevent govern-
ment agents from returning to conduct a particularized
search and seizure without first obtaining an ordinary
warrant. Cf. United States v. Articles of Drug Consisting of
Following: Undetermined Quantity of 100-Capsule .Bottles,
etc., 568 F. Supp. 1182 (N.D. Cal. 1983).

Theramatic is binding authority directly on point. The
agents in this case had previously conducted administra-
tive inspections pursuant to § 374. The constitutionality
of these inspections is not at issue here. Based on their
conclusion that Argent was in violation of the Act, the
agents obtained the in rem arrest warrant to search a
particular business to seize particular, identified chemi-
cals and diugs. The arrest warrant was issued, pursuant
to § 334 and Supplemental Rule C, by a deputy clerk who
did not, indeed could not, review the government's alle-
gations to determine if there was cause to seize the items.
This is precisely what the Ninth Circuit forbade in Thera-
matic.

The government argues that Theramatic is distin-
guishable on the ground that the search there involved a
doctor’s office, not a drug factory. The Court is unper-
suaded by this distinction. First, the Supreme Court deci-
sions interpreting the Fourth Amendment’s reach into the
commercial realm do not make a distinction between a

2 It is worth noting in this context that during a warrantless
inspection under § 374, the agents may take samples. They may
proceed to seize and forfeit items only under § 334. There is
nothing unusual about the suggestion that the seizure under
§ 334 requires greater safeguards than the inspection under
§ 374.

B-9

business or professional office and a factory. Rather, the
Court has simply stated that the Fourth Amendment pro-
tects “private commercial property,” See, 87 S. Ct. at 1739,
and “commercial buildings.” Barlow’s, 98 S. Ct. at 1819.
Second, the government’s approach would tend to create
a confusing body of case law giving law enforcement
officers unreliable standards for determining whether
and when to obtain judicially-authorized warrants.

Finally, the government cites a number of district
court decisions authorizing the in rem arrest procedure in
the context of violations of the FD&C Act. E.g., United
States v. Articles of Drug . . . WANS, 526 F. Supp. 703, 706
(D.P.R. 1981); United States v. Undetermined quantities
of . . . blue-green algae, 1983 WL 1076 (D. Or. 1983). The
Court is not free to follow the reasoning of other district
courts in the face of countervailing Ninth Circuit author-

ity.

Ill. CONCLUSION

The Ninth Circuit has held unambiguously that
agents seeking to enter a business office to seize items
alleged to violate the Food, Drug, and Cosmetic Act must
comply with the Fourth Amendment BY obtaining a war-
rant based upon probable cause and authorized by a
detached judicial officer. Argent Chemical’s motion to
quash is therefore GRANTED. The government is hereby
ORDERED to return the seized property to Argent Chem-
icals.

B-10

SO ORDERED this 15th day of Dec., 1994.

/s/ JOHN C. COUGHENOUR
The Honorable John C. Coughenour
United States District Judge

C-1

APPENDIX C
Pertinent Provisions of the Food, Drug and Cosmetic Act

21 U.S.C. 334(a):
§ 334 Seizure
(a) Grounds and jurisdiction

(1) Any article of food, drug, or cosmetic that is
adulterated or misbranded when introduced into or while
in interstate commerce or while held for sale (whether or
not the first sale) after shipment in interstate commerce,
or which may not, under the provisions of section 344 or
355 of this title, be introduced into interstate commercz,
shall be liable to be proceeded against while in interstate
commerce, or at any time thereafter, on libel of informa-
tion and condemned in any district court of the United
States or United States court of a Territory within the
jurisdiction of which the article is found. No libel for
condemnation shall be instituted under this chapter, for
any alleged misbranding if there is pending in any court
a libel for condemnation proceeding under this chapter
based upon the same alleged misbranding, and not more
than one such proceeding shall be instituted if no such
proceeding is so pending, except that such limitations
shall not apply (A) when such misbranding has been the
basis of a prior judgment in favor of the United States, in
a criminal, injunction, or libel for condemnation proceed-
ing under this chapter, or (B) when the Secretary has
probable cause to believe from facts found, without hear-
ing, by him or any officer or employee of the Department
that the misbranded article is dangerous to health, or that
the labeling of the misbranded article is fraudulent, or

C-2

would be in a material respect misleading to the injury or
demage of the purchaser or consumer. In any case where
the number of libel for condemnation proceedings is lim-
ited as above provided the proceeding pending or insti-
tuted shall, on application of the claimant, seasonably
made, be removed for trial to any district agreed upon by
stipulation between the parties, or, in case of failure to so
stipulate within a reasonable time, the claimant may
apply to the court of the district in which the-seizure has
been made, and such court (after giving the United States
attorney for such district reasonable notice and oppor-
tunity to be heard) shall by order, unless good cause to
the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, to
which the case shall be removed for trial.

(b) Procedure; multiplicity of pending proceedings

The article, equipment, or other thing proceeded
against shall be liable to seizure by process pursuant to
the libel, and the procedure in cases under this section
shall conform, as nearly as may be, to the procedure in
admiralty; except that on demand of either party any
issue of fact joined in any such case shall be tried by jury.
When libel for condemnation proceedings under this sec-
tion, involving the same claimant and the same issues of
adulteration or misbranding, are pending in two or more
jurisdictions, such pending proceedings, upon applica-
tion of the claimant seasonably made to the court of one
such jurisdiction, shall be consolidated for trial by order
of such court, and tried in (1) any district selected by the
claimant where one of such proceedings is pending; or (2)
a district agreed upon by stipulation between the parties.

C-3

If no order for consolidation is so made within a reason-
able time, the claimant may apply to the court of one such
jurisdiction and such court (after giving the United States
attorney for such district reasonable notice and oppor-
tunity to be heard) shall by order, unless good cause to
the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in
which all such pending proceedings shall be consolidated
for trial and tried. Such order of consolidation shall not
apply so as to require the removal of any case the date for
trial of which has been fixed. The court granting such
order shall give prompt notification thereof to the other
courts having jurisdiction of the cases covered thereby.

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APPENDIX D

Supplemental Rules for Certain Admiralty and Maritime
Claims Rule C. Actions in Rem: Special Provisions

(1) When Avarcasie. An action in rem may be brought:
(a) To enforce any maritime lien;

(b) Whenever a statute of the United
States provides for a maritime action in rem or a
proceeding analogous thereto.

Except as otherwise provided by law a party who
may proceed in rem may also, or in the alternative, pro-
ceed in personam against any person who may be liable.

Statutory provisions exempting vessels or other
property owned or possessed by or operated by or for the
United States from arrest or seizure are not affected by
this rule. When a statute so provides, an action against
the United States or an instrumentality thereof may pro-
ceed on in rem principles.

(2) Complaint. In actions in rem the complaint shall
be verified on oath or solemn affirmation. It shall
describe with reasonable particularity the property that is
the subject of the action and state that it is within the
district or will be during the pendency of the action. In
actions for the enforcement of forfeitures for violation of

any statute of the United States the complaint shall state
the place of seizure and whether it was on land or on
navigable waters, and shall contain such allegations as
may be required by the statute pursuant to which the
action is brought.

E-1

APPENDIX E
§ 374 Inspection

(a) Right ot agents to enter; scope of inspection; notice;
promptness; exclusions. (1) For purposes of enforcement
of this Act, officers or employees duly designated by the
Secretary, upon presenting appropriate credentials and a
written notice to the owner, operator, or agent in charge,
are authorized (A) to enter, at reasonable times, any
factory, warehouse, or establishment in which food,
drugs, devices, or cosmetics are manufactured, processed,
packed, or held, for introduction into interstate commerce
or after such introduction, or to enter any vehicle being
used to transport or hold such food, drugs, devices, or
cosmetics in interstate commerce; and (B) to inspect, at
reasonable times and within reasonable limits and in a
reasonable manner, such factory, warehouse, establish-
ment, or vehicle and all pertinent equipment, finished
and unfinished materials, containers, and labeling
therein. In the case of any factory, warehouse, establish-
ment, or consulting laboratory in which prescription
drugs or restricted devices are manufactured, processed,
packed, or held, the inspection shall extend to all things
therein (including records, files, papers, processes, con-
trols, and facilities) bearing on whether prescription
drugs or restricted devices which are adulterated or mis-
branded within the meaning of this Act, or which may
not be manufactured, introduced into interstate com-
merce, or sold, or offered for sale by reason of any
provision of this Act, have been or are being manufac-
tured, processed, packed, transported, or held in any
such place, or otherwise bearing on violation of this Act.
No inspection authorized by the preceding sentence or by

E-2

paragraph (3) shall extend to financial data, sales data
other than shipment data, pricing data, personnel data
(other than data as to qualifications of technical and
professional personnel performing functions subject to
this Act), and research data (other than data relating to
new drugs, antibiotic drugs, and devices and subject to
reporting and inspection under regulations lawfully
issued pursuant to section 505(i) or (k), section 507(d) or
(g), section 519, or 520(g) [21 USCS § 355(i) or (k), § 357(d)
or (g), § 360i, or § 360j(g)], and data relating to other
drugs or devices which in the case of a new drug would
be subject to reporting or inspection under lawful regula-
tions issued pursuant to section 505(j) [21 USCS §
355(j)]). A separate notice shall be given for each such
inspection, but a notice shall not be required for each
entry made during the period covered by the inspection.
Each such inspection shall be commenced and completed
with reasonable promptness.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386018_1790%3A1. Public record. Not legal advice.