Respondents Brief — Touby v. United States (No. 90-6282)

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FOR ARGUMENE ee

No. 90-6282

In the Supreme Court of the Unit

OCTOBER TERM, 1990

DANIEL TOUBY AND LYRISSA TOUBY, PETITIONERS

v.

UNITED STATES OF AMERICA

ON WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

BRIEF FOR THE UNITED STATES

KENNETH W. STARR

Solicitor General

ROBERT S. MUELLER, III

Assistant Attorney General

WILLIAM C. BRYSON

Deputy Solicitor General

JEFFREY P. MINEAR

199]

HE CLERK

Assistant to the Solicitor General

RICHARD A. FRIEDMAN

Attorney

Department of Justice

Washington, D.C. 20530

(202) 514-2217

® Whiimie Wy

QUESTIONS PRESENTED

1. Whether Section 201(h) of the Controlled Sub-

stances Act unconstitutionally delegates to the Attorney

General the authority to list a drug temporarily as a

schedule I controlled substance.

2. Whether the Attorney General lawfully delegated

his authority under Section 201(h) to the Administrator

of the Drug Enforcement Administration.

(I)

TABLE OF CONTENTS

Opinions below _........................ ipceieiesiabantisdishes iain stabi

a ssustmndeetueibsonoowatnesees

Statute and regulation involved —.........0.00000000...... a Oe

a ssevntevenntumsounecs

A. The Controlled Substances Act 00000000.

B. The temporary listing of Euphoria as a schedule

I controlled substance .......0000000000000.. rane trier

C. The facts and proceedings in this case ..............

NE

Argument:

I. Section 201(h) does not violate the Constitu-,

tion’s requirement that “all legislative powers”

shall be vested in Congress ......0000000- 0000000.

A. Section 201(h) satisfies established delega-

EE CEL,

B. The Constitution does not prohibit Congress

from authorizing the Attorney General to

exercise the authority conferred by Section

a scsapnerenstihoctvecooses

C. Congress has provided constitutionally ade-

quate judicial oversight of Section 201 (h)

scheduling decisions ...... + EN a

Il. The Attorney General lawfully subdelegated his

Section 201(h) authority to the Administrator

of the Drug Enforcement Administration ._.

Conclusion ......... eeiitelbibenubeiascenssbonsoce SA

Appendix A ................ Rn iiiilinhsiendeprentncuketeasbobacsonccsceoseeee

Ee isla hiemconestiioe mama

TABLE OF AUTHORITIES

Cases:

Adamo Wrecking Co. v. United States, 434 US.

Teen ecououus eka

(IIT)

17

19

25

32

39

44

la

5a

36

McKinley v. United States, 249 U.S. 397 (1919).. 23

- v

Cases—Continued : Page

Cases—Continued : Page mas

. McNary V. Haitian Refugee Center, Inc., No. 89-

A.L.A. Schechter Poultry Corp. v. United States, Os is ks SN 2h ad ho 35

295 U.S. 495 (1935) eo eeeonecoeenseee on ennnennnes 18 Mistretta vy. United States, 488 U.S. 361 (1989).. 11, 15,

American Power & Light Co. v. SEC, 329 U.S. 90 17, 18, 19, 22, 25, 26

CRO) aii ccna ssecnesitsnrcconenscensenepesnnasemennnsstononenenn 18, 30 Monongahela Bridge Co. v. United States, 216

Avent v. United States, 266 U.S. 127 (1924) japan 23 2 ee eS eee 23, 24, 35

Bowen V. stenigan Academy of Family Physicians, National Broadcasting Co. v. United States, 319

476 U.S. 667 (1986) - ...... essvsssanssssenserenseennseeeneeee 86 Ci Te Scien 12, 14, 18, 30

Boyce Motor Lines, Inc. v. United States, 342 U.S. Panama Refining Co. Vv. Ryan, 293 U.S. 388

CD ieecrnenseipipmsesccvsvcznsninsnasantscnninenncsiontenene 35 A ae IEE 18

Califano v. Sanders, 430 U.S. 99 (1977) ....... 35 Reckitt & Colman, Ltd. v. DEA, 788 F.2d 22

Cargo of the Brig Aurora V. United States, 11 U.S. I i Oe ee re 32

(7 Cranch) 382 (1813)... Rostker v. Goldberg, 453 U.S. 57 (1981) ............ 19

Carter Vv. United States, 333 F.2d 354 (10th Cir. Skinner vy. Mid-America Pipeline Co., 490 U.S.

ICM) nee aanneencnennecneeeecnettnectnnertncttnceenets -- 81 2 RR ORI 19, 22, 23, 34

Cincinnati, W. & Z. R.R. v. Commissioners of Clin- Union Bridge Co. v. United States, 204 U.S. 364

ton County, 1 Ohio St. 77 (1852) ............-..0....... 24 OU id as ed Fie en enna 23, 24, 35

Clark v. Gabriel, 393 U.S. 256 (1968) .................... 37, 38 United States vy. Alerander, 673 F.2d 287 (9th

Cudahy Packing Co. Vv. Holland, 315 U.S. 357 Cir.), cert. denied, 459 U.S. 876 (1982)... 31

(1942) ...........-.-.--. covsssseenncenneennnsssseeeeenncnnnanetiteeteeeee 41 United States vy. Barron, 594 F.2d 1345 (10th

Dunlop Vv. Bachowski, 421 U.S. 560 (1975) ........... 35 Cir.), cert. denied, 441 U.S. 951 (1979) 31

Estep v. United States, 327 U.S. 114 (1946) _......... 35, 36 United States v. Berrigan, 482 F.2d 171 (3d Cir.

Ewing v. Mytinger & Casselberry, Inc., 389 U.S. aS SE ES pi 31

RG CIID nssstenressesesscersempscensonnnsennivoennctones 16, 36-37, 38 United States v. Chatman, 538 F.2d 567 (4th Cir.

Fahey Vv. Mallonee, 332 U.S. 245 (1947) ................. 22, 29 STEARNS E ee 31

FCC v. Schreiber, 381 U.S. 279 (1965) .................. 29 United States v. Emerson, 846 F.2d 541 (9th Cir.

Field v. Clark, 148 U.S. 649 (1892) ..........0--....-... 24 0 ENG rea net ee ae 11

Fleming V. Mohawk Wrecking & Lumber Co., 331 United States v. Giordano, 416 U.S. 505 (1974)... 41, 42

Fe 41, 42 United States v. Gordon, 580 F.2d 827 (5th Cir.),

FPC v. Hope Natural Gas Co., 320 U.S. 591 cert. denied, 439 U.S. 1051 (1978)... 31

(1944) -nneenennnneeeneseeeeceececeseeeeeeeeeetee coseccnceeeceeenee 18 United States v. Grimaud, 220 U.S. 506 (1911) .18, 23, 24

Grinspoon V. DEA, 828 F.2d 881 (1st Cir. 1987) .... 6, 32 United States v. Koopmans, 757 F.2d 901 (7th

Johnson V. Robison, 415 U.S. 361 (1974) —.............. 35 = eee aie 31

J.W. Hampton, Jr., & Co. v. United States, 276 United States v. Park, 521 F.2d 1381 (9th Cir.

oe 11, 17, 18, 22, 24 a CE EO oe Sh 81

Kollock, In re, 165 U.S. 526 (1897) -.....-------------- 23, 24 United States v. Pastor, 557 F.2d 930 (2d Cir.

Larson V. Domestic & Foreign Commerce Corp., I Es i ei ie tae a 31

337 U.S. 682 (1949)... enncoe-seeeeessseeeeeneneneeecnee 34 United States v. Roya, 574 F.2d 386 (7th Cir.),

Lichter v. United States, 334 U.S. 742 (1948)... 12, 14, 18 cert. denied, 439 U.S. 857 (1978) ..................... 31

McGee V. United States, 402 U.S. 479 (1971)........ 33 United States vy. Salerno, 481 U.S. 739 (1987)... 19

United States v. Spain, 825 F.2d 1426 (10th Cir.

VI

Cases—Continued : Page

United States v. Widdowson, 916 F.2d 587 (10th

Cir. 1990) ............ a Ea a aes 11, 13

Witmer v. United States, 348 U.S. 375 (1955)... 37

Yakus v. United States, 321 U.S. 414 (1944)....... 18, 22

Constitution, statutes and regulations:

U.S. Const. :

Art. I:

OT us a a eeapiedemaminaiininemmennaiat 17

§8, Cl. 18 (Necessary and Proper

III... -setpesenndteeilenenesaepainndsneiinasestsntins 28

Art. II

ce as aeaideianenaienesiiopaenamnasiannitii 26

i eas ceeccatbianiielanaaanl 26

Amend. V (Due Process Clause) ................-...--. 29, 37

ain 29

Act of Sept. 6, 1966, ch. 31, § 4(c), 80 Stat. 612... 7, 13,

40, 41, 42

Administrative Procedure Act, 5 U.S.C. 551 et

seq.:

pn SR ceceemeenneenenntaanentas 3

i senenenmmndenniibsmeseiepseanbnans 3

EEE ERSTE SPAR b SRS ev Owen cnet T ere Sw 3

I a sg naenneennenniente 34

i on iceassenennesiauntionh 37

a linbnnnaieneaeienliin 35

Clean Air Act, 42 U.S.C. 7401 et seq.:

§ 307(b) (1), 42 U.S.C. 7607 (b) (1) .........-........ 35

§ 307 (b) (2), 42 U.S.C. 7607 (b) (2) ................ 35, 36

Comprehensive Crime Control Act of 1984, § 1203

(c), Pub. L. No. 98-473, 98 Stat. 2152 ............... ; 5

Comprehensive Drug Abuse Prevention and Con-

trol Act of 1970, Pub. L. No. 91-518, 84 Stat.

IT acerca nn taanhesiaensennitentignsidinenengsennusesmaetnantnen 2

Comprehensive Environmental Response, Compen-

sation, and Liability Act of 1980, 42 U.S.C. 9613

EID <a. icsnscheciesararjannniatacainsesaienbiannesanabemnndanniatenesbaebedaigeniaes 37

Controlled Substances Act, as amended, 21 U.S.C.

801 et seq.:

i A I OO a cicnasaeinneninnceinetinsen 2

§§ 101-709, 21 U.S.C. 801-904 20... eee eeee es 40

VII

Statutes and regulations—Continued : Page

§ 102(14), 21 U.S.C. 802(14) oo 8

§ 201 (a), 21 U.S.C. 811(a) 0. 3, 4, 6, 10, 12, 33, 39

eg Ge We cnc scecscceseceneececncocoeeces 28, 36

BE Gag BR TITRE, BER GOD macs cccccccececenecccsecceces 3,4

§ 201 (c) (4), 21 U.S.C. 811 (e) (4) 5

§ 201 (c) (4)-(6), 21 U.S.C. 811 (c) (4)-(6) ...... 20

§ 201 (c) (5), 21 U.S.C. 811 (c) (5) 5

§ 201 (c) (6), 21 U.S.C. 811 (c) (6) 5

§ 201 (h), 21 U.S.C. 811 (h) WW... passim, la

§ 201 (h) (1), 21 U.S.C. 811 (h) (1) 6, 13, 20, 21

§ 201(h) (1) (A), 21 U.S.C. 811(h) (1) (A)... 6

§ 201 (h) (1) (B), 21 U.S.C. 811(h) (1) (B).... 6

§ 201 (h) (2), 21 U.S.C. 811 (h(2) oo. 6, 32

§ 201 (h) (3), 21 U.S.C. 811 (h) (3) _...... 5, 8, 9, 20, 28

§ 201 (h) (4), 21 U.S.C, 811 (h) (4) oe. 6, 9

§ 201 (h) (5), 21 U.S.C. 811 (h) (5) oo. 6

§ 201 (h) (6), 21 U.S.C. 811 (h) (6) .......6, 7, 18, 15, 32,

33, 34, 35, 36

ee MID orciscesttitiicnacecconnconinons nua - 3

§ 202(b), 21 U.S.C. 812(b) nnn nen 4,19, 21

§ 202(b) (1), 21 U.S.C. 812(b) (1) _4, 5, 6, 8-9, 20, 21

§ 202(b) (1) (B), 21 U.S.C. 812(b) (1) (B).... 21

§ 202(b) (2) (B), 21 U.S.C. 812(b) (2) (B).... 21

§ 202 (b) (3) (B), 21 U.S.C. 812(b) (3) (B).... 21

§ 202(b) (4) (B), 21 U.S.C. 812(b) (4) (B).... 21

§ 202 (b) (5) (B), 21 U.S.C. 812(b) (5) (B).... 21

§ 202(h), 21 U.S.C. 812 (In) occ eceececeeeeeee 5

§§ 301-310, 21 U.S.C. 821-830 eee eeee 3,4

§ 401 (a), 21 U.S.C. 841 (a) oo ceceeeceeceeeeeeeees 3, 10

§ 406, 21 U.S.C. 846 o.oo. ccccoecocececcccenececececeneceees 10

§ 501(a), 21 U.S.C. 871 (a) 7, 14, 16, 40

§ 507, 21 U.S.C. 877 00... 4, 7, 15, 32, 34, 35, 36

Controlled Substances Penalties Amendments Act

of 1984, Pub. L. No 98-473, Tit. II, ch. 5, 98

Stat. 2068 ........ he RPS Ra Eo Pee orn REE Se 5

Fair Labor Standards Act of 1938, ch. 676, § 4(b),

RRR a root then oe ae 41

Omnibus Crime Control and Safe Streets Act of

1968, Tit. III, 18 U.S.C. 2510 et seq. 0. 41

§ 802, 18 U.S.C. 2516 (1970) 20 e eee 41, 42

VIII

Statutes and regulations—-Continued: Page

Rivers and Harbors Appropriation Act of 1899,

Te CO) 8. Oya 24

LE ee ee ae ee en 43

I ls 43

eh laseanens 43

i, ESE PS ea a RE 22

fo Ee rae Oe scghidieidmemiains 22

ESSIEN oD eT I ore 22

I a amegemenien 32

I 32

SEERA EE ee oS TE re ee 43

EE Ee 43

IRA ANE re Dee ee oe ee Me Rep 43

ER RE ee era aE 43

SLE Be eae Seva A ore SCM 43

I 43

ER SESE Ra se a RC CRE REVO 43

I 43

I 43

I 22

RE EEE EERE Se ae eo a 22

RE RE SRT SO RRA Ore eT es Hee ae 26

pe DD reece eececsccccssceccccecccencccee 33

A eet er ae ce a oe 22

ETA Me SE a 23

in Ee a le Deg RU ae ee 23

gf | eee PRON Se aar ED 43

ERLISTE fe EST IR NNT ene Oe CCE 43

A ns I ns iuuesenuns 31

a SEER aR eo Aas SUR Seep 31, 32

REECE Se OPE anne nO aes Pee oe Looe 31

pe | a NS | | aa 43

ED I ee ae Sm ee 23

ET aa a RE a RT A See ee ST 23

EE EAE ee ee Ae One, ne NOON eee 21

EES RE ee A See Ae eae ee 26

RUE EERIE OE Segoe bee cou oser ir ee 33

Se es i 33

eee nee cae 7, 13, 16, 40

StI Se SS RO ON IED OR: OLE te 29

be oe: | | sits 34

IX

Statutes and regulations—Continued: Page

4g REEDS ie Pee ea eee 26

I 23

TE eel, eerie 26

A SET Ear Cs. Saree 23

EL: a a 43

I 43

a 23

ee 23

SS EOE mn aeae 23

38 U.S.C. 5025 (b) (3) (C) ..0...oo. ecco ceoee------------ se. 43

OP le PI ID aciceecccccccacesececeemmesecieee ose 43

ee 43

i NOE SET Rae cere 43

Oe 43

41 U.S.C. 423 (d) (7) (B) ........0... 43

A a 23

Oe ID cries ecedincccee secenseecneesseceensecee 23

EEE AES Seer ne ese 23

42 U.S.C. 8374(e) Siotintamiaddbenaniag ans omit oo 43

rer 23

RIESE RE NEE at tel ca SS meer 43

ee I 43

er 43

| SAE Ee eee eee sega ED a 23

a 23

| ee 23

ES | ae 43

Cf eee 23

A a 23

21 C.F.R.:

Section 1308.02 (c) ..... BRE te IES FER 8

ey OD ss 8

33 C.7.B. O260Cs) (1068) ..................... 7

SR eee 2, 39, 40, 3a

Miscellaneous:

Administrative Procedure in Government Agen-

cies, S. Doe. No. 8, 77th Cong., 1st Sess.

LESSENS See oe HE Oa eC TT 35

Miscellaneous—Continued : Page

Cramton, Nonstatutory Review of Federal Ad-

ministrative Action: The Need For Statutory

Reform of Sovereign Immunity, Subject Mat-

ter Jurisdiction, and Parties Defendant, 68

ee S| Ue eee 34

Sr a i I I 7

52 Fed. Reg. (1987) :

REEL a nana ae Ree ene Te 7,40

aes Se Ca ee ee ee a 8, 28

ELS DIE Re T oe ae re ST 8,9

EET EE ea Se a eee 9

RE ree mee ee 9

53 Fed. Reg. (1988) :

BREE SETS cee ae we 9

REET SRS a dee ee aL a Oe ee dueemsion 9

54 Fed. Reg. 14,799 (1989) ...............ccccccccececccceccooeeee 10

H.R. Rep. No. 835, 98th Cong., 2d Sess. (1984)... 20, 33

S. 1762, 98th Cong., Ist Sess. (1983) ............ 20

S. Rep. No. 225, 98th Cong., 1st Sess. (1983) ..5, 13, 20, 31

U.S. Dep’t of Justice, Attorney General’s Manual

on the Administrative Procedure Act (1947).... 35

Ju the Supreme Court of the United States

OCTOBER TERM, 1990

No. 90-6282

DANIEL TOUBY AND LYRISSA TOUBY, PETITIONERS

Vv.

UNITED STATES OF AMERICA

ON WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

BRIEF FOR THE UNITED STATES

OPINIONS BELOW

The opinion of the court of appeals (J.A. 27-66) is re-

ported at $09 F.2d 759. The opinion of the district court

(J.A. 2-26) is reported at 710 F. Supp. 551.

JURISDICTION

The judgment of the court of appeals was entered on

July 27, 1990. A petition for rehearing was denied on

August 21, 1990. The petition for a writ of certiorari

was filed on November 19, 1990, and was granted on

January 14, 1991. The jurisdiction of this Court rests

on 28 U.S.C. 1254(1).

STATUTE AND REGULATION INVOLVED

Section 201(h) of the Controlled Substances Act, 21

ULS.C. 811th), and 28 C.F.R. 0.100(b) are set out in

Appendix A to this brief.

(1)

2

STATEMENT

Section 201(h) of the Controlled Substances Act, 21

U.S.C. 811th), provides the Attorney General with a

streamlined procedure for temporarily listing a drug as

a schedule I controlled substance when he finds that the

action is “necessary to avoid an imminent hazard to the

publie safety.” On October 15, 1987, the Attorney Gen-

eral’s delegate, the Administartor of the Drug Enforce-

ment Administration (DEA), used that authority to list

4-methylaminorex—a stimulant known in street vernacu-

lar as “Euphoria’’—temporarily as a schedule I controlled

substance pending proceedings for permanent listing.

While the temporary listing was in effect, petitioners

Danie! and Lyrissa Touby were arrested and charged

under the Controlled Substances Act with conspiring to

manufacture and knowingly manufacturing 4-methy!-

aminorex. Petitioners do not contend that Euphoria can-

not be listed as a schedule I controlled substance, and

since their arrest the drug has been permanently listed

as such. They challenge their convictions solely on the

theory that the Controlled Substances Act’s temporary

listing provisions unconstitutionally delegate legislative

power to the Executive Branch and, alternatively, that

the Attorney General unlawfully delegated his authority

under the statute to the Administrator of the DEA.

A. The Controlled Substances Act

1. In 1970, Congress enacted the Comprehensive Drug

Abuse Prevention and Control Act, Pub. L. No. 91-513,

84 Stat. 1236. Title II of that enactment, known as the

Controlled Substances Act (CSA), regulates the importa-

tion, manufacture, distribution, possession, and improper

use of substances that have a detrimental effect on public

health and welfare. See CSA § 101, 21 U.S.C. 801. It

establishes five schedules of controlled substances, includes

a list of substances initially placed on each schedule, and

contemplates the periodic reevaluation of the initial lists

and the addition of other substances to the schedules. See

3

CSA § 202, 21 U.S.C. 812. Once a substance is placed on

one of the schedules, manufacturers, distributors, and

dispensers of the substance must comply with various

regulatory requirements. See CSA §§ 301-310, 21 U.S.C.

821-830. Unauthorized possession of the substance with

intent to distribute it is a criminal offense. CSA § 401(a),

21 U.S.C. 841 (a).'

Section 201(a)} of the Act, 21 U.S.C. 811(a), grants

the Attorney General authority to add substances to the

schedules of controlled substances through a rulemaking

on the record pursuant to provisions of the Administra-

tive Procedure Act, 5 U.S.C. 553(¢c), 556, 557. Section

201(b) requires the Attorney General to receive the rec-

ommendation of the Secretary of Health and Human Serv-

ices (HHS) before initiating such a rulemaking respect-

ing a substance proposed for scheduling as a controlled

substance. 21 U.S.C. 811(b). The Secretary’s recom-

mendations are controlling as to scientific and medical

matters, and a substance cannot be placed on the sched-

ules if the Secretary recommends against listing it. See-

tion 201(c) identifies eight factors that the Attorney

General and the Secretary of HHS must consider in mak-

ing their determinations whether a substance should be

listed on a controlled substance schedule. 21 U.S.C.

811(c).?

1 Petitioners focus exclusively on how the five schedules affect the

gradation of criminal penalties applicable to illegal possession or dis-

tribution of controlled substances. Pet. Br. 3. Certain of the regu-

latory requirements of Sections 301-310 also apply differently to the

five schedules.

2 Section 201(c) requires consideration of the following factors

relating to the substance under consideration:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the

drug or other substance.

(4) Its history and current pattern of abuse.

d

Section 202(b) of the Act identifies the specific cri-

teria for adding a substance to each of the schedules.

With exceptions not pertinent here, that provision states

that ‘‘a drug or other substance may not be placed in any

schedule unless the findings required for such schedule

are made with respect to such drug or other substance.”

21 U.S.C. 812(b). The findings required to add a sub-

stance to schedule I are as follows:

(A) The drug or other substance has a high

potential for abuse.

(B) The drug or other substance has no cur-

rently accepted medical use in treatment in the

United States.

(C) There is a lack of accepted safety for use of

the drug or other substance under medical super-

vision.

CSA § 202(b) (1), 21 U.S.C. 812(b) (1). Thus, to add a

substance to schedule I, the Attorney General must deter-

mine through a rulemaking that the substance meets

those three criteria in light of the eight factors identified

in Section 201(c), 21 U.S.C. 811(¢). The scheduling of

a substance under Sections 201(a) and 202(b) is sub-

ject to judicial review in a court of appeals upon petition

by any “aggrieved” person. See CSA § 507, 21 U.S.C.

877.°

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a sub-

stance already controlled under this subchapter.

21 U.S.C. 811(c).

’ Aggrieved persons would include manufacturers, distributors,

and dispensers subject to the regulatory restrictions of Sections 301

through 310. That class includes petitioners and others who propose

to engage in those activities without complying with the regulatory

restrictions.

5

2. In 1984, Congress enacted the Comprehensive Crime

Control Act, which amended the Controlled Substances

Act in various respects. See Controlled Substances Pen-

alties Amendments Act of 1984, Pub. L. No. 98-473, Tit.

II, ch. V, 98 Stat. 2068. Among the amendments, Con-

gress added a new subsection, Section 201(h), to the

Controlled Substances Act. That new subsection, codi-

fied at 21 U.S.C. 811(h), establishes an expedited pro-

cedure for temporarily listing a schedule I substance

when the Attorney General finds that such expedition “is

necessary to avoid an imminent hazard to the public

safety.” Section 201(h) “is designed to allow the Attor-

ney General to respond quickly to protect the public from

drugs of abuse that appear in the illicit traffic too rap-

idly to be effectively handled under the lengthy routine

control procedures.” S. Rep. No. 225, 98th Cong., 1st

Sess. 264-265 (1983).

Section 201(h)(3) directs the Attorney General to

make the “imminent hazard” determination based on

three factors: (1) the drug’s history and current pat-

tern of abuse; (2) the scope, duration, and significance

of abuse; and (3) the risk to the public health, giving

specific consideration to “actual abuse, diversion from

legitimate channels, and clandestine importation, manu-

facture, or distribution.” 21 U.S.C. 811(h) (3) (incor-

porating 21 U.S.C. 811(¢) (4), (5) and (6)). Section

201(h), however, does not dispense with the requirement

that a drug listed on schedule I have the characteristics

of a schedule I controlled substance. Hence, to list a sub-

stance temporarily on schedule I, the Attorney General

must not only make the Section 201(h) “imminent haz-

ard” determination that justifies expedited rulemaking;

in accordance with Section 202(b)(1), the substance

must also exhibit a high potential for abuse, it must have

no currently accepted medical use, and there must be a

lack of accepted safety for its use under medical super-

vision. 21 U.S.C. 812(b) (1).4

4 Accordingly, we disagree with petitioners’ statements (Br. 5-6,

14 n.9) that Section 202(h) requires only an “imminent hazard”

6

Before issuing an order listing a substance of a tem-

porary basis under Section 201(h), the Attorney General

must publish a notice of proposed listing in the Federal!

Register and transmit a notice of the proposed order to

the Secretary of HHS. CSA § 201(h)(1)(A) and (B),

(h) (4), 21 U.S.C. 811(h)(1)(A) and (B), (h) (4).

The Attorney General must then wait 30 days after the

Federal Register notice and the HHS transmittal before

issuing the order. In deciding whether to list a substance

following this 30-day period, the Attorney General must

take into account any comments submitted by the Secre-

tary of HHS, but the prior approval of the Secretary is

not required, as would be the case for a permanent list-

ing. CSA § 201(h) (4), 21 U.S.C. 811(h) (4); compare

CSA § 201(b), 21 U.S.C. 811(b).

A Section 201(h) temporary listing expires at the end

of one year except that, if the Attorney General has in-

stituted rulemaking proceedings for the permanent list-

ing of the substance under Section 201(a), the Attorney

General may extend the temporary listing for up to six

months. CSA § 201(h) (2), 21 U.S.C. 811th)(2). In

any event, the temporary listing expires upon the com-

pletion of permanent rulemaking respecting the listing

of the substance. CSA § 201(h) (5), 21 U.S.C. 811(h)

(5). Subsection 201(h) (6) provides that the Attorney

General’s order temporarily listing a drug as a schedule

I substance “is not subject to judicial review.” 21 U.S.C.

811(h) (6). This provision postpones the special statu-

determination to list a substance in schedule I through expedited

rulemaking. As the court of appeals stated, Section 202(b) (1)’s

three schedule I criteria are “independent of the factors which sec-

tion [201(h)] requires the Attorney General to consider in exercis-

ing the designated temporary scheduling power.” J.A. 38. The

Attorney General’s determination that the drug poses an “imminent

hazard,”’ however, will generally satisfy the first criterion, while his

determination that there is no FDA exemption or approval in effect

for the drug, see 21 U.S.C. 811(h) (1), will satisfy the second and

third criteria. See Grinspoon v. DEA, 828 F.2d 881, 889 (1st Cir.

1987).

7

tory review mechanism set forth in Section 507—-which,

as we have explained, provides “aggrieved parties” with

judicial review in the appropriate court of appeals—

until the conclusion of permanent rulemaking procedures.

See CSA § 507, 21 U.S.C. 877."

3. Congress has provided, through Section 4(c) of the

Act of Sept. 6, 1966, ch. 31, 80 Stat. 612, that the Attor-

ney General “may from time to time make such provi-

sions as he considers appropriate authorizing the per-

formance by any other officer, employee, or agency of the

Department of Justice of any function of the Attorney

General.” 28 U.S.C. 510. In addition, Section 501(a) of

the Controlled Substances Act provides that the “Attor-

ney General may delegate any of his functions under

[the control and enforcement subchapter of the Act] to

any officer cr employee of the Department of Justice.”

21 U.S.C. 871(a).

In 1973, the Attorney General delegated the perform-

ance of his duties under the Controlled Substances Act,

including the scheduling of drugs, to the Administrator

of the DEA. 38 Fed. Reg. 18,380. See 28 C.F.R. 0.100

(b) (1986). That delegation was amended in 1987 to

clarify that it included the authority to schedule sub-

stances on a temporary basis under the expedited pro-

cedures of Section 201(h). 52 Fed. Reg. 24,447. See 28

C.F.R. 0.100(b).°

5 For the reasons discussed below, at pp. 33-36, Section 201 (h) (6)

does not preclude a court from determining whether a desig-

nated drug is properly listed as a schedule I substance in the

course of a criminal enforcement proceeding. Accordingly, we dis-

agree with petitioners’ contrary characterizations of the statute.

See Pet. Br. 5, 26-28.

®The Attorney General’s 1987 subdelegation was issued in re-

sponse to a court of appeals decision holding that the 1973 subdele-

gation to the Administrator did not encompass the later-enacted

authority conferred by Section 201(h). See United States v. Spain,

825 F.2d 1426 (10th Cir. 1987).

8

B. The Temporary Listing Of Euphoria As A Schedule I

Controlled Substance

1. On August, 13, 1987, the Administrator of the DEA

proposed the temporary listing of 4-methylaminorex

(formally known as (+) cis-4, 5-dihydro-2-amino-4-

methyl-5-phenyl-2-oxazolamine) as a schedule I controlled

substance. 52 Fed. Reg. 30,174." The Administrator ob-

served that the drug “is a new substance that is clande-

stinely produced, that is distributed in illicit traffic, and

that produces stimulant effects,” and therefore “is cer-

tainly the type of drug which Congress intended to be

considered for emergency scheduling.” /bid. Citing vari-

ous studies, the Administrator also noted that 4-methy]l-

aminorex’s pharmacological profile resembles that of am-

phetamine; that in high doses it produces “seizure activity

in the brain and associated convulsions, depression, res-

piratory failure, and death”; and that the DEA was not

aware of any commercial manufacturers or suppliers of

the drug or of any approved therapeutic use. Jd. at

30,175.

The Administrator made the necessary findings for

listing under Sections 201(h) of the Controlled Sub-

stances Act. He considered the history, pattern, and sig-

nificance of abuse, and the risk the drug posed to public

safety. 52 Fed. Reg. 30,174. See CSA § 201(h) (3), 21

U.S.C. 811(h) (3). He also identified the characteristics

necessary to qualify the substance for schedule I listing,

referring to “the potent stimulant and toxic actions of

the substance, and the lack of accepted medical use or

established safety for the use of 4-methylaminorex.” 52

Fed. Reg. at 30,174. See CSA § 202(b) (1), 21 U.S.C.

™The (+) prefix indicates that the listed substance is actually a

mixture of two optical isomers. Under the Controlled Substances

Act’s definitions, the listing of 4-methylaminorex includes the sub-

stance’s individual optical isomers. See CSA § 102(14), 21 U.S.C.

802(14); 21 C.F.R. 1308.02(c) and 1308.11(f). In addition to its

street name and formal chemical name, 4-methylaminorex is also

identified in pharmacology studies as “U4Euh,” “ICE,” and “McN-

822.”

9

812(b) (1). Based on a consideration of the factors re-

quired by Section 201(h) (3), as well as the finding

that the drug qualified as a schedule I controlled sub-

stance under Section 202(b) (1), the Administrator con-

cluded that listing 4-methylaminorex in schedule I, at

least on a temporary basis, was “necessary to avoid an

imminent hazard to the public safety.” 52 Fed. Reg.

30,175. Pursuant to Section 201(h) (4), the Administra-

tor notified the Assistance Secretary of Health and Hu-

man Services of the proposed scheduling. Ibid.

2. On October 15, 1987, the Administrator published

an order temporarily listing 4-methylaminorex as a

schedule I controlled substance, effective on that date.

52 Fed. Reg. 38,225. In response to the notice of intent

to schedule the drug, the Food and Drug Administration

(FDA) of HHS had advised the DEA that it had no

objections to the schedule I listing of the substance. /bid.

No comments were received from any other interested

parties. Jbid. Based on the information discussed in the

August 13 notice of proposed listing, the Administrator

stated his finding that the temporary listing of the drug

as a schedule I controlled substance was necessary to

avoid an imminent hazard to the public safety. Jd. at

38,225-38,226. The notice specifically warned that any

unauthorized activity respecting the drug was henceforth

unlawful and subject to criminal penalties. /bid.

3. On October 13, 1988, the Administrator extended

the duration of the temporary listing for an additional

six months, through April 15, 1989, or until completion

of rulemaking proceedings to schedule the drug on a per-

manent basis, whichever occurred first. 53 Fed. Reg.

40,061. The next day, he issued a notice of intent to

schedule the Crug permanently. 53 Fed. Reg. 40,391.

On April 13, 1989, 4-methylaminorex was permanently

8 That decision was based, in part, on a recommendation by the

DEA’s Drue Control Section. See 53 Fed. Reg. 40,391. We have

reprinted that recommendation, which is part of the administrative

record, as an appendix to this brief. See App. B, infra.

10

listed as a schedule I controlled substance after the com-

pletion of rulemaking under Section 201(a). 54 Fed.

Reg. 14,799.

C. The Facts And Proceedings In This Case

1. On January 5, 1989, police officers in Wanaque,

New Jersey, arrested petitioners after they purchased «

television set with a counterfeit cashier’s check. A search

incident to the arrest found petitioners to be in posses-

sion of marijuana and drug paraphernalia. Based on

further investigation, a warrant was obtained to search

petitioner’s home for counterfeiting materials and drugs.

When DEA agents executed the warrant on January 6,

1989, they discovered a fully operational drug laboratory

in petitioners’ bedroom. Among the items seized were

papers containing the formula for manufacturing 4-

methylaminorex. Also seized were mixtures that, upon

testing, were found to contain the drug.® J.A. 19-21

49-50.

2. On January 11, 1989, a grand jury in the United

States District Court for the District of New Jersey re-

turned a two-count indictment charging petitioners with

unlawful manufacture of a schedule I controlled sub-

stance and conspiracy to manufacture that substance,

in violation of the Controlled Substances Act. See CSA

$$ 401l/a), 406, 21 U.S.C. 841(a), 846. At the time of

the alleged offenses, the Administrator of the DEA had

temporarily listed 4-methylaminorex as a_ schedule I

ecntrolled substance pursuant to Section 201(h), but he

had not completed the rulemaking for permanent listing

of the substance. J.A. 2, 28.

®In September 1988, Daniel Touby had purchased cyanogen bro-

mide from the Eastman Kodak Company. In October 1988, Lyrissa

Touby had obtained sodium acetate, sodium carbonate, potassium

carbonate, and norephedrine hydrochloride from a chemical sup-

plier. Expert testimony established that those chemicals are used

to make 4-methylaminorex. J.A. 49.

aan

11

Petitioners challenged the constitutionality of Section

201(h) in a pretrial motion to dismiss the indictment.

They contended that Congress had impermissibly dele-

gated to the Attorney General legislative power to crim-

inalize activity concerning 4-methylaminorex by author-

izing him to list the drug as a schedule I controlled

substance on a temporary basis. Petitioners also con-

tended that the Attorney General could not in any event

delegate his temporary listing authority to the Adiminis-

trator. The district court rejected both challenges in an

opinion dated March 17, 1989. J.A. 11-19. After a jury

trial, petitioners were convicted as charged in the in-

dictment. Daniel Touby was sentenced to 42 months’ im-

prisonment and Lyrissa Touby was sentenced to 27

months’ imprisonment, each term of imprisonment to be

followed by three years’ supervised release. J.A. 28.

3. The court of appeals affirmed petitioners’ convic-

tions, rejecting their challenges to the temporary sched-

uling procedure. J.A. 27-54. The court first held that

Congress had not impermissibly delegated its legislative

power to the Attorney General by authorizing him to

list drugs as controlled substances on a _ temporary

basis.” J.A. 33-43. It noted that this Court has sus-

tained broad assignments of authority to the Executive

Branch, as long as the relevant congressional enactment

lays down an “intelligible principle” directing the re-

sponsible official’s actions. /d. at 34-35, quoting Mis-

tretta Vv. United States, 488 U.S. 261, 372 (1989), and

J.W. Hampton, Jr., & Co. v. United States, 276 U.S. 394,

409 (1928).

The court rejected petitioners’ contention that a more

stringent nondelegation standard should be applied in

10 The Ninth Circuit reached the same result in United States vy.

Emerson, 846 F.2d 541, 545-546 (1988). The Tenth Circuit has

held, however, that Section 201(h) is an unconstitutional delega-

tion of legislative power. United States v. Widdowson, 916 F.2d

587, 589-591 (1990).

12

this case because Section 201(h) permits the Attorney

General to “create” crimes. J.A. 35-38. It explained

that this Court has not in fact applied a more stringent

test in considering the validity of statutes authorizing

administrative regulation of conduct giving rise to crim-

inal liability, J.A. 36-37, and that Section 201(h) does

not authorize the Attorney General to define primary

criminal conduct, because Congress itself has proscribed

the manufacture and possession of controlled substances,

while the Attorney General “merely designat{es] the

drugs or substances which fall within Congress’ general

description.” J.A. 37-38.

Applying this Court’s “intelligible principle” test, the

court of appeals concluded that Section 201(h) provides

the Attorney General with sufficient guidance for mak-

ing the “imminent hazard” finding required for tem-

porary listing of substances. J.A. 39-40. The court ob-

served that the statutory standards provide at least as

much guidance as the “public interest, convenience, in-

terest, or necessity” standard that was found to be suffi-

cient to guide the Federal Communications Commission

in National Broadcasting Co, v. United States, 319 U.S.

190, 225-227 (1943), or the “excessive profits” standard

for renegotiation of wartime contracts that was sus-

tained in Lichter v. United States, 334 U.S. 742, 783-

787 (1948). J.A. 39-40.

Moreover, the court of appeals found that the consti-

tutionality of Section 201(h) was reinforced by the lim-

ited scope of the temporary scheduling, which “can be

viewed as preliminary to and in aid of the permanent

scheduling authority as set forth in section [201(a)],”

J.A. 40, and by the practical necessities of the situation

confronting Congress. The court observed that Congress

had found the permanent listing procedures inadequate

to address the situation of “designer drugs” that are

similar to listed substances but contain slight variations,

and it noted that the purpose of the temporary listing

authority is to “avoid an imminent hazard to the public

13

safety,” 21 U.S.C. 811(h) (1), by imposing an “ ‘emer-

gency control’” during the interim between identifica-

tion of a drug that presents a major abuse problem and

the permar-nt scheduling of the substance—a_ period

during which “ ‘enforcement actions against traffickers

[were] severely limited and a serious health problem

may arise.” J.A. 39, 40 (quoting S. Rep. No. 225,

supra, at 264, 265).

Finally, the court rejected petitioners’ contention that

Section 201(h)(6)’s limitation on judicial review of

an order listing a drug on a temporary basis renders

Section 201(h) an unconstitutional delegation of legis-

lative power. J.A. 41-43. The court pointed out that

Congress has foreclosed judicial review in a variety of

other administrative contexts. J.A. 42-43. It also stated

that Section 201(h) (6) does not necessarily bar judi-

cial review of the temporary listing in a criminal prose-

cution, if the defendant claims that the listing of the

particular drug violated the standards in Section 201(h).

J.A. 33 n.2, 42-43. But in this case, the court noted,

petitioners “do not contend that Euphoria cannot be

scheduled as a Schedule | narcotic or that the temporary

scheduling of the substance did not meet the standards

set forth in 21 U.S.C. $ 811th).” J.A. 33.

The court of appeals next held that Section 4(c) of

the Act of September 6, 1966, 28 U.S.C. 510, empowered

the Attorney General to delegate his temporary listing

authority to the Administrator of the DEA." J.A. 43-

46. The court cited the general rule that in the absence

of a contrary expression by Congress, powers conferred

on an Executive Branch officer may be delegated to a

subordinate official, J.A. 45, and it found no support for

the proposition that Congress intended sub silentio to

create an exception to the Attorney General’s broad

delegation authority under Section 4/¢) in the context

The Tenth Circuit has reached the opposite conclusion, hold-

ing that the Section 201(h) authority is nondelegable. United

States v. Widdowson, 916 F.2d at 591-593.

14

of the listing of controlled substances on a temporary

basis pursuant to Section 201(h)."*? The court further

found that the Attorney General did, in fact, delegate

his Section 201(h) authority to the Administrator. J.A.

46-48.

Judge Hutchinson dissented. J.A. 54-66. He agreed

with the majority that the record did not suggest that

the Attorney General acted arbitrarily or otherwise im-

properly in temporarily listing Euphoria as a controlled

substance under Section 201(h) or that Euphoria is not

a danger to the public safety. J.A. 55. Judge Hutchin-

son also accepted the majority’s analysis of the statutory

background and the nature of the problem to which Sec-

tion 201th) is addressed, J.A. 55, and he concluded that

Section 201(h)’s purpose of avoiding “‘an imminent

hazard to the public safety’ is in and of itself an in-

telligible principle under the teachings of the Supreme

Court.” J.A. 58, citing National Broadcasting Co. v.

United States, 319 U.S. at 225-226, and Lichter v. United

States, 334 U.S. at 783-787. But Judge Hutchinson

nevertheless believed that Section 201(h) unconstitu-

tionally delegates Congress’s legislative power because,

in his view, it authorizes the Attorney General to define

primary criminal conduct and therefore should be sub-

ject to a more stringent non-delegation test. J.A. 58-61."

1? Because the court found adequate subdelegation authority under

Section 4(c), it did not reach the question whether Section 501 (a)

of the Controlled Substances Act, 21 U.S.C. 871(a), provided an

independent basis for such delegation. J.A. 46 n.4.

13 Because he believed that Section 201(h) is unconstitutional,

Judge Hutchinson did not reach the question of the statutory

validity of the Attorney General’s delegation of his temporary

listing authority to the Administrator of the DEA. J.A. 55 n.1.

15

SUMMARY OF ARGUMENT

1. The Constitution divides and diffuses governmental

power among the “three coequal Branches.” Mistretta v.

United States, 488 U.S. 361, 380 (1989). This Court’s

requirement that Congress provide an intelligible prin-

ciple to guide an executive officer’s administration of a

statute maintains that separation of powers by assuring

that no “legislative power”—as the Constitution uses

that term—is delegated to the Executive Branch. Once

it is determined, through application of that standard,

that Congress has conferred only executive functions, the

delegation inquiry is at an end. Separation of powers

principles do not prevent Congress from selecting the

Attorney General, rather than another Executive Branch

official, to perform the executive function. Indeed, Con-

gress had sound policy reasons for vesting the Attorney

General with the Section 201 (h) temporary listing au-

thority, and the potential for abuse that petitioners posit

simply does not exist.

Petitioners are also mistaken in arguing that Section

201(h) is an unconstitutional delegation because Con-

gress has provided inadequate opportunity for judicial

oversight of the Attorney General’s temporary listing

decisions. A temporary listing of a substance is simply

the first step in the administrative process for determ-

ining whether the substance should be permanently

listed. As petitioners recognize. Section 507 of the Con-

trolled Substances Act specifically authorizes judicial re-

view if the substance is permanently listed. 21 U.S.C.

877. Petitioners object, however, that Section 201(h) (6)

precludes Section 507 review during the interim period

of up to 18 months while the permanent rule is under

consideration and the temporary listing is in effect.

There is no merit to that objection. Individuals who

insist on manufacturing and selling hazardous substances

during that interim period may challenge the Attorney

General’s listing decision in a criminal enforcement pro-

16

ceeding. The government is not required to stay its

hand until the courts have an opportunity to determine

whether government is justified in bringing an enforce-

ment action. See Ewing v. Mytinger & Casselberry, Inc.,

359 U.S. 594, 598-599 (1950).

2. Petitioners also argue that the Attorney General

lacks siatutory authority to delegate his Section 201 (h)

responsibilities to the Administrator of the DEA. Con-

gress, however, has authorized that subdelegation under

two separate statutes. First, Congress has given the

Attorney General broad authority to delegate the per-

formance of “any” of his functions to another officer,

employee, or agency of the Department of Justice. 28

U.S.C. 510. Second, Congress specifically provided in

Section 501(a) of the Controlled Substances Act that the

Attorney General ‘‘may delegate any of his functions”

under the control and enforcement provisions of that

Act to any officer or employee of the Department. 21

U.S.C. 871(a). There is no indication in the Controlled

Substances Act that Congress intended to except the

Attorney General’s responsibilities under Section 201

(h) from those delegation provisions. The Attorney Gen-

eral accordingly had ample statutory authority to dele-

gate his Section 201(h) responsibilities to the Adminis-

trator of the DEA.

17

ARGUMENT

I. SECTION 201(h) DOES NOT VIOLATE THE CON-

STITUTION’S REQUIREMENT THAT “ALL LEGIS-

LATIVE POWERS” SHALL BE VESTED IN CON-

GRESS

The Constitution provides that “[a]ll legislative Powers

herein granted shall be vested in a Congress of the United

States.” U.S. Const. Art. I, § 1. Petitioners contend that

Congress has violated that requirement by creating sched-

ules of controlled substances, providing the initial con-

tents of those schedules, and then authorizing the Attor-

ney General to add—temporarily, pending formal rule-

making—other substances that he has identified as posing

“an imminent hazard to the public safety.” § 201(h), 21

U.S.C. 811(h). Although petitioners contend that Con-

gress’s action is “unprecedented” (Br. 15), “strikes at

the heart of the system of checks and balances that guar-

antee the rule of law” (Br. 15) and undermines individ-

ual liberty “at its core” (Br. 18), they also recognize that

this Court’s precedents narrowly restrict the scope of

their challenge.

Petitioners accept that “the separation-of-powers prin-

ciple, and the nondelegation doctrine in particular, do not

prevent Congress from obtaining the assistance of its

coordinate Branches.” Mistretta v. United States, 488

U.S. 361, 372 (1989). They also accept (Br. 12-13, 21)

the principle “now enshrined in our jurisprudence” that:

“In determining what [Congress] may do in seek-

ing assistance from another branch, the extent and

character of that assistance must be fixed according

to common sense and the inherent necessities of the

government coordination.”

Mistretta, 488 U.S. at 372, quoting J.W. Hampton, Jr.,

& Co. v. United States, 276 U.S. 394, 406 (1928).

Petitioners acknowledge that “Congress has often

granted executive departments and agencies the author-

ity to promulgate regulations that govern private con-

18

duct, and some of the resulting regulations are enforce-

able through criminal prosecutions.” Br. 19. See, e.g.,

Yakus v. United States, 321 U.S. 414 (1944); United

States v. Grimaud, 220 U.S. 506 (1911). And they ac-

knowledge, more indirectiy (Br. 13 & n.7, 22 n.14, 24),

the firmly established rule that

's]o long as Congress “shall lay down by legislative

act an intelligible principle to which the person or

body authorized to [exercise the delegated author-

ity] is directed to conform, such legislative action

is not a forbidden delegation of legislative power.”

Mistretta, 488 U.S. at 372, quoting J.W. Hampton, Jr.,

& Co., 276 U.S. at 409."

Petitioners do not claim that Congress has failed to set

forth an “intelligible principle” to guide the Attorney

General's listing of substances on a temporary or perma-

nent basis. Indeed, they expressly disclaim any challenge

to “the specificity of the substantive standards that Con-

gress established to govern the exercise of delegated

powers.” Br. 13, 21. And, as the court of appeals stated,

14 Petitioners also acknowledge (Br. 22 n.14), as recited in

Mistretta, that this Court’s application of the “intelligible prin-

ciple” test has resulted in rejection of virtually every challenge

to legislation on the ground that it unconstitutionally delegated

legislative power. 488 U.S. at 373-374. See, e.g., Lichter v. United

States, 334 U.S. 742 (1948) (authority to determine excess profits) ;

American Power & Light Co. v. SEC, 329 U.S. 90 (1946) (author-

ity to prevent unfair or inequitable distribution of voting power

among security holders); Yakus v. United States, 321 U.S. 414

(1944) (authority to fix commodity prices at fair and equitable

levels) ; FPC v. Hope Natural Gas Co., 320 U.S. 591 (1944) (author-

ity to determine just and reasonable rates) National Broadcasting

Co. Vv. United States, 319 U.S. 190 (1943) (authority to regulate

broadcast licensing as public interest, convenience, or necessity

require). The only two exceptions, Panama Refining Co. v. Ryan,

293 U.S. 388 (1935), and A.L.A. Schechter Poultry Corp. v. United

States, 295 U.S. 495 (1935), involved a statute in which Congress

“failed to articulate any policy or standard that would serve to con-

fine the discretion of the authorities to whom Congress had dele-

gated power.” Mistretta, 488 U.S. at 373 n.7.

19

petitioners “do not contend that Euphoria cannot be sched-

uled as a Schedule I narcotic or that the temporary

scheduling of the substance did not meet the standards

set forth in 21 U.S.C. § 811(h).” J.A. 33.

Ultimately, petitioners seek an exception to this Court’s

settled delegation principles based on two points: the At-

torney General (rather than some other executive official)

exercises the authority conferred under the statute (Br.

14-23); and the statute’s temporary listing provisions do

not provide for pre-enforcement review (Br. 24-35). As

we explain below, Congress’s conferral of authority in

this case is plainly constitutional under this Court’s set-

tled standards and is not, as petitioners suggest, “un-

precedented” (Br. 15, 19, 30). The factors that petition-

ers claim distinguish this case—the identity of the par-

ticular executive officer who exercises the delegated au-

thority, and the timing of judicial review-—do not call for

a different analysis or dictate a different result.

A. Section 201(h) Satisfies Established Delegation

Standards

Petitioners face a difficult task in demonstrating that

a duly enacted congressional statute is facially unconsti-

tutional. See, e.g., Mistretta, 488 U.S. at 384; United

States v. Salerno, 481 U.S. 739, 745 (1987); Rostker v.

Goldberg, 453 U.S. 57, 64 (1981). That task is especially

difficult in this case because, as the lower courts held and

petitioners concede, Congress’s delegation of authority to

the Attorney General under Section 201(h) amply satis-

fies the “intelligible principle” test that this Court has

consistently employed to determine the constitutionality

of challenged delegations. See Skinner v. Mid-America

Pipeline Co., 490 U.S. 212, 218-219, 224 (1989);

Mistretta, 488 U.S. at 372-374.

1. Sections 201(h) and 202(b) set forth “intelligible”

-—and indeed quite precise—standards to channel the At-

torney General’s discretion in identifying substances for

temporary listing as schedule I controlled substances.

First, the substance must present “an imminent hazard

20

to the public safety,’ CSA §201(h)(1), 21 U.S.C.

811th) (1), as determined after consideration of the sub-

stance’s history and current pattern of abuse, the scope,

duration and significance of abuse, the risk to the public

health, the diversion from legitimate channels, and

clandestine importation, manufacture, or distribution,

CSA § 261/(¢) (4)-(6), (h) (3), 21 U.S.C. 811/¢) (4)-(6),

811(h) (3). Second, to qualify for listing on schedule I, a

substance must have “a high potential for abuse,” it must

have “no currently accepted medical use in treatment in

the United States,” and there must be “a lack of accepted

safety for use of the drug or other substance under medi-

cal supervision.” CSA § 202(b)(1), 21 U.S.C. 812

(b) (1)."° There is no question in this case that these

standards meet the “intelligible principle” test for up-

holding Congress’s delegation of authority.

2. While petitioners state that they do “not challenge

the specificity of the substantive standards that Congress

established to govern the exercise of [the Section 201 (h) ]

delegated powers,”’ Pet. Br. 13, 21, they nevertheless

claim that the Attorney General may act with “unfet-

15 A proposed, but not enacted, version of Section 201(h) would

have authorized the Attorney General to list a substance on any

schedule for which it qualified, but would have given the Sec-

retary of HHS authority to veto the expedited scheduling. See

S. 1762, 98th Cong., Ist Sess. (1983), as reported in S. Rep. No.

225, supra, at 616-617. The enacted version, however, authorized

the Attorney General to list temporarily only schedule I sub-

stances and eliminated the Secretary’s veto power. The House Com-

mittee on the Judiciary explained:

In examining the particular substances for which the sched-

uling action was most necessary, the Subcommittee concluded

that limiting the authority only to substances that have no

currently accepted medical use in treatment addressed both

the legitimate concerns of those in the health care industry

and the principal danger to the public health.

H.R. Rep. No. 835, 98th Cong., 2d Sess. 10 (1984). In short, the

health care industry’s concerns were accommodated, and the need

for the Secretary’s veto power were eliminated, by limiting the

temporary scheduling authority to schedule I substances. See note

4, supra.

21

tered discretion” in selecting “any drug’ for emergency

schedule I listing under Section 201(h), Pet. Br. 14, 24.

Petitioners overlook the significance of the requirements

that a substance listed on an emergency basis must both

pose an “imminent hazard” and meet the three criteria

for schedule I listing set in out Section 202(b!(1). See

Pet. Br. 14 n.9. For example, one of the key distinctions

drawn by Section 202'b) between schedule I substances

and substances qualifying for inclusion on the other sched-

ules is the lack of a “currently accepted medical use in

treatmeni in the United States.” 21 U.S.C. 812(b) (1)

(B).° Each of the other schedules includes substances

that have a currently accepted medical use. See 21 U.S.C.

$12(bi (2) (Bi, (3)(B!, (4)(B), and (5)(B). Thus,

petitioners’ suggestion (Br. 24) that the Attorney General

“could add a substance as innocuous as aspirin to Sched-

ule I” is not only farfetched, but is precluded by the

statute."®

3. Petitioners also suggest (Br. 15-16, 30-31) that

when Congress delegates authority to the Executive

Branch to identify specific conduct that may result in

criminal prosecution there is a need for “heightened con-

stitutional concerns.” This Court, however, has never re-

jected application of the “intelligible principle” test in

the criminal context. The relevant inquiry remains

whether Congress has set forth standards sufficiently

16Other passages of petitioners’ brief seem to sugyest that

Section 201(h) was intended to regulate only fundamentally new

drugs. See Br. 6 n.3, 14 n.9. Congress recognized, however, that

a drug (such as naturally occurring peyote) may exist long before

there emerges a need—resulting from the drug’s abuse—to control

its distribution. Hence, there is no requirement that the drug be

“newly designed or created” (Pet. Br. 6 n.3). Instead, to qualify

for temporary listing under Section 201(h), the substance must

not already be listed on any of the schedules, the substance must

not be subject to an exemption or approval under the FDA’s new-

drug provisions of 21 U.S.C. 355, and the temporary listing of the

substance must be “necessary to avoid an imminent hazard to the

public safety.”” CSA § 201(h) (1), 21 U.S.C. 811 (h) (1).

22

specific to guide the executive official’s exercise of discre-

tion. Cf. Skinner, 490 U.S. at 222-223 (rejecting the

“application of a different and stricter nondelegation doc-

trine in cases where Congress delegates discretionary au-

thority to the Executive under its taxing power’’)."”

For example, in Yakus v. United States, 321 U.S. 414

(1944), this Court upheld a delegation of authority to fix

maximum commodity prices and rents even though viola-

tion of the regulations was a criminal offense. There was

no suggestion in that case that a more stringent standard

of delegation applied. Similarly, in J.W. Hampton, Jr.,

& Co., 276 U.S. at 406, the Court observed that Congress

frequently secures the “the exact effect” of legislation by

vesting discretion in executive officers to make regulations

“directing the details of its execution, even to the extent

of providing for penalizing a breach of such regulations.”

276 U.S. at 406. Indeed, the instances are legion where

Congress has authorized Executive Branch agencies to

prescribe regulations or to make administrative determi-

nations that may result in the imposition of criminal

punishment.'* This Court has repeatedly upheld such au-

17 Petitioners rely on statements in Mistretta and Fahey v. Mal-

lonee, 332 U.S. 245, 250 (1947), that characterize the statute at

issue in Schechter Poultry and Panama Refining as delegating

power to make “federal crimes of acts that never had been such

before” and to create “new crimes in uncharted fields.” Fahey,

332 U.S. at 249, 250; see Mistretta, 488 U.S. at 373 n.7. The point

of those statements was not that a different constitutional standard

applies to regulations with penal consequences, but rather that the

delegations at issue in Schechter Poultry and Panama Refining were

unconstitutional because “Congress had failed to articulate any

policy or standard that would serve to confine the discretion of the

authorities to whom Congress had delegated power.” Mistretta, 488

U.S. at 373 n.7 (emphasis added).

18 See, e.g., 7 U.S.C. 87b(a) (11), 87¢ (Department of Agricul-

ture grain regulations); 7 U.S.C. 2024(b) (Department of Agri-

culture food stamp regulations); 15 U.S.C. 78ff (violation of Se-

curities and Exchange Commission regulations); 15 U.S.C. 2070

(violation of Consumer Product Safety Commission regulations) ;

15 U.S.C. 2615(b) (violation of Environmental] Protection Agency

23

thorizations without regard to their penal consequences.

See, e.g., Avent Vv. United States, 266 U.S. 127 (1924);

McKinley v. United States, 249 U.S. 397 (1919) ; United

States v. Grimaud, 220 U.S. 506 (1911); Monongahela

Bridge Co. v. United States, 216 U.S. 177 (1910) ; Union

Bridge Co. v. United States, 204 U.S. 364 (1907); In re ©

Kollock, 165 U.S. 526 (1897)."

4. Congress’s prescription of “intelligible principles” is

sufficient, by itself, to assure that Section 201(h) does

not delegate “legislative power’—in the sense the Con-

stitution uses that term—to the Executive Branch. See

Skinner, 490 U.S. at 218-219. Indeed, prior to the devel-

toxic substance control regulations); 15 U.S.C. 3414(c) (2) (viola-

tion of Federal Energy Regulatory Commission natural gas regu-

lations) ; 16 U.S.C. 773g (violation of International Pacific Halibut

Commission regulations); 19 U.S.C. 1436(c), 1459(g) (violation

of Presidential regulations pertaining to international investment) ;

29 U.S.C. 666(e) (violation of Occupational Safety and Health

Administration regulations) ; 30 U.S.C. 1268 (violation of Depart-

ment of Interior orders); 31 U.S.C. 5322 (violation of Depart-

ment of Treasury reguiations respecting monetary instruments

transactions) ; 33 U.S.C. 1319, 1415 (violation of EPA water quality

regulations); 42 U.S.C. 4910(a) (violation of EPA noise control

regulations); 42 U.S.C. 6928(d) (violation of EPA solid waste

management regulations); 42 U.S.C. 6992d (violation of EPA

medical waste regulations); 42 U.S.C. 8432 (violation of Depart-

ment of Energy regulations); 42 U.S.C. 9603 (violation of EPA

hazardous substance reporting requirements); 43 U.S.C. 1350

(violation of Department of Interior regulations respecting outer

continental shelf leasing) ; 46 U.S.C. 3718(b) (violation of Depart-

ment of the Treasury regulations respecting inspection of vessels) :

49 U.S.C. 521(b) (6), 11903 (violation of Interstate Commerce Com-

mission requirements).

1 Even if delegations involving the creation of novel criminal

liability warranted closer scrutiny, that scrutiny wou!d not be

necessary in this case. As the court of appeals observed, the At-

torney General has had authority since 1970 to identify substances

for permanent placement on schedule I, and the courts have re-

peatedly upheld that authority. J.A. 37. Congress, not the Attorney

General, has prescribed the elements of the criminal offenses involv-

ing such substances and has defined the penalties. Thus, the scope

of the Attorney General’s delegated authority is quite narrow.

24

opment of that test, this Court repeatedly stated that

statutes conditioning the application of the law on exec-

utive determinations do not delegate lawmaking author-

ity at all; rather, they confer “an authority or discre-

tion as to its execution, to be exercised under and in

pursuance of the law.” J.W. Hampton, Jr., & Co., 276

U.S. at 407, and Field v. Clark, 143 U.S. 649, 693-694

(1892), quoting Cincinnati, W. & Z. R.R. v. Commission-

ers of Clinton County, 1 Ohio St. 77, 88-89 (1852) .7°

20 For example, in United States v. Grimaud, supra, the Court

observed that the Secretary of Agriculture “did not legislate” when

he promulgated criminally enforceable grazing regulations pursuant

to the laws establishing national forests because he “did not go

outside of the circle of that which the act itself had affirmatively

required to be done, or treated as unlawful if done.” 229 U.S. at

518. Rather, the Secretary was fulfilling the executive function “to

administer the law and carry the statute into effect.” Jbid.

Similarly, in Monongahela Bridge Co. v. United States, supra, the

Court rejected an unlawful delegation claim in a criminal prosecu-

tion based on the Secretary of War’s administrative determination

that a bridge constituted an obstruction to navigation under Section

18 of the Rivers and Harbors Appropriation Act of 1899, ch. 425,

36 Stat. 1151. 216 U.S. at 192. Justice Harlan stated for the Court

that the Secretary “could not be said to exercise strictly legislative

or judicial power” where he simply determines, pursuant to con-

gressional directive, “some facts or some state of things upon which

the enforcement of [a statute] may depend.” Jd. at 193.

The Court reached the same result under similar facts in Union

Bridge Co. v. United States, 204 U.S. at 386 (“In performing that

duty the Secretary of War will only execute the clearly expressed

will of Congress, and will not, in any true sense, exert legislative or

judicial power.”). See also, e.g., Field v. Clark, 143 U.S. at 694

(“The legislature cannot delegate its power to make a law; but it

can make a law to delegate a power to determine some fact or state

of things upon which the law makes, or intends to make, its own

action depend.”); In re Kollock, 165 U.S. at 533 (“The regulation

was in execution of, or supplementary to, but not in conflict with,

the law itself, and was specifically authorized thereby in effectuation

of the legislation which created the offense.”); Cargo of the Brig

Aurora V. United States, 11 U.S. (7 Cranch) 382, 388 (1813) (‘we

can see no sufficient reason, why the legislature should not exercise

its discretion * * * either expressly or conditionally, as their judg-

ment should direct’’).

25

The Court's “intelligible principle” standard has fur-

ther refined that reasoning by recognizing that if Con-

gress has failed to articulate intelligible principles to

guide the executive officer’s exercise of discretion under

the statute, there may be a de facto delegation of legisla-

tive power. See Mistretta, 488 U.S. at 418-419 (Scalia,

J., dissenting). Once it is determined, however, that the

executive officer is executing Congress’s will pursuant to

ascertainable legislative guidelines, that is the end of the

delegation inquiry. In cases such as this one, where Con-

gress has set forth specific standards to direct the Attor-

ney General's exercise of discretion, there is no delegation

of legislative power at all. See Mistretta, 488 U.S. at 379.

B. The Constitution Does Not Prohibit Congress From

Authorizing The Attorney General To Exercise The

Authority Conferred By Section 201(h)

Petitioners argue that satisfaction of this Court’s “in-

telligible principle” standard is not enough in this case.

They contend (Br. 14-23) that Section 201:h) violates

delegation principles by committing the temporary sched-

uling decision to the Attorney General rather than to

some other executive official, such as the Secretary of

HHS. Petitioners assert (Br. 14) that Congress’s choice

results in an “unconstitutional aggregation of power’’ be-

cause it gives the Attorney General “unilateral authority

to create crimes and prosecute violators.”” This novel ar-

rument misconceives both the nature of the Constitution’s

separation of powers principle and the specific responsi-

bilities of the Attorney General.

1. This Court “consistently has given voice to, and has

reaffirmed, the central judgment of the Framers of the

Constitution that, within our political scheme, the separa-

tion of governmental powers into three coordinate

Branches is essential to the preservation of liberty.”

Mistretta, 488 U.S. at 380. But the concept of separation

of powers always focuses on the distribution of powers

among the “three coequal Branches.” Jbid. What is for-

26

hidden are “provisions of law that either accrete to a

single Branch powers more appropriately diffused among

separate Branches or that undermine the authority and

independence of one or another coordinate Branch.” 7/d.

at 382.

This Court has never suggested that separation o*

powers principles govern the aggregation of powers

within subdivisions of the Executive Branch. Indeed, the

Constitution provides no premise for such an approach

because it vests all executive power in the President, U.S.

Const. Art. II, $1, and requires him to see that the

laws are “faithfully executed,” U.S. Const. Art. II, § 3.

From a constitutional perspective, the Executive Branch’s

authority to administer statutes through the promulgation

of regulations is necessarily and always aggregated with

the Executive Branch’s authority to enforce the law

through penal and other legislatively prescribed means.

The promulgation of regulations and the prosecution of

offenses are simply different aspects of the Executive's

function.

2. Petitioners recognize that there is nothing novel in

Congress authorizing Executive Branch officials to pro-

scribe dangerous substances upon determination that the

substances pose an “imminent hazard to the public safety”

and to enforce those proscriptions through criminal pen-

alties. CSA § 201(h'!, 21 U.S.C. 811(h).*' They concede

that “the need for flexibility and expertise may well jus-

tify delegation of the temporary scheduling power to some

21 Compare, e.g., 15 U.S.C. 2605(d) (authorizing the Administra-

tor of the Environmental Protection Agency to impose immediate

restrictions on the manufacture of toxic substances that pose an

unreasonable risk of serious or widespread injury); 21 U.S.C.

355(e) (authorizing the Secretary of Health and Human Services

to suspend approval of new drugs upon finding an imminent hazard

to public health health) ; 29 U.S.C. 655(c) (authorizing the Secre-

tary of Labor to promuigate emergency temporary occupational

safety standards); 30 U.S.C. 811(b) (authorizing the Secretary of

Labor to promulgate emergency temporary mine safety standards).

See also note 18, supra.

27

executive officer.”” Br. 22. Petitioners argue (Br. 15, 22-

23), however, that Congress should have vested the Sec-

retary of HHS, rather the Attorney General, with the

authority to make the temporary listing decision to avoid

aggregating “criminal lawmaking and _ prosecutorial

power.” That argument, however, does really not rest on

the constitutional! doctrine of separation of powers, but

simply challenges the wisdom of a legislative policy judg-

ment.**

Petitioners err at the outset by simply assuming that

Congress has delegated “criminal lawmaking” power to

the Attorney General—even though, as they concede,

Congress has provided an “intelligible principle” to con-

trol the executive’s exercise of discretion. As we have

explained (pp. 19-25, supra), Congress’s articulation of

clear standards to guide executive discretion ensures thai

the Attorney General performs only executive functions.

That should end the delegation inquiry. The extent to

which a particular function is executive in nature does

not depend on which Executive Branch official performs

the function. Indeed, petitioners are unable to cite a

single instance in which this Court has invalidated any

Act of Congress on the ground that it gave one Execu-

tive Branch official, rather than another, authority over

a particular executive function.

*2 The Constitution does not create a Department of Justice and

a separate Department of Health and Human Services. Under the

constitutional scheme, Congress could create a Department of Jus-

tice, Health, and Human Services, headed by a single official. Or, it

could make all of the Executive Branch departments subunits within

a single entity headed by one officer of the United States acting

under the direction of the President. Nothing in the Constitution

would prohibit such a scheme, as long as the President remained

supreme over the Executive Branch. Because the functions of

different departments could be performed by a single department

without violating separation of powers principles, it makes no sense

to say that separation of powers principles are offended if the exe-

cutive functions of scheduling and enforcement are performed

within a single department, rather than separate departments

within the Executive Branch.

28

Congress has broad authority, under the Necessary

and Proper Clause, U.S. Const. Art. I, $8, Cl. 18, to

create or select the appropriate Executive Brance officer

to perform a particular executive function. Congress

vested the Attorney General with authority to make tem-

porary scheduling decisions because, in Congress’s judg-

ment, the Attorney General is best situated to determine

whether a substance poses an “imminent hazard to the

public safety.” Specifically, Congress enacted the tempo-

rary listing provisions to deal with the emergent abuse of

unlisted drugs. CSA § 201(h) (3), 21 U.S.C. 811(h) (3)

(requiring that the imminent hazard determination be

based on considerations related to abuse and risk to the

public health). As a general matter, the Controlled Sub-

stances Act vests the Attorney General with primary re-

sponsibility for determining abuse characteristics. See

CSA § 201(b), 21 U.S.C. 811(b) (restricting the Secre-

tary of HHS to consideration of the “scientific or medi-

cal” aspects of abuse characteristics). Thus, it is quite

reasonable that Congress would vest the Attorney Gen-

eral, rather than the Secretary of HHS, with the im-

minent hazard determination.

Congress’s decision that the Attorney General, rather

than the Secretary of HHS, should make the imminent

hazard determination is also consistent with the “real

world” aspects of the problem. As in the case of Eu-

phoria, the government typically ‘earns that a drug poses

an imminent hazard through criminal investigations by

the DEA or state law enforcement authorities that reveal

emerging abuse patterns. See 52 Fed. Reg. 30,174

(1987); App., infra, Ta, 9a, 12a. Thus, the Attorney

General, who supervises the DEA and coordinates law en-

forcement activities with the States, is best situated to

respond promptly to the imminent public safety menace

posed by drugs such as Euphoria, which are produced

and sold through clandestine operations.

3. Petitioners argue, nevertheless, that the Attorney

General’s regulatory and prosecutive functions must be

29

separated to prevent “ ‘tyrannical’ abuse.” Br. 15-19.

They suggest that the Attorney General might use his

Section 201(h) authority to provide a means for prose-

cuting “targeted” individuals. Br. 18-19. That argu-

ment, however, does not rest on the constitutional con-

cept of separation of powers, but rather on the notion

that particular officials with the Executive Branch

cannot be trusted to execute faithfully Congress’s direc-

tives. See Pet. Br. 18.

As petitioners recognize (Br. 17 n.12), the Constitu-

tion, through the Due Process Clause and the specific

guarantees in the Fifth and Sixth Amendments, provides

significant safeguards against abuses of the power of

prosecution. In addition, Congress can provide further

safeguards through statutes and rules of procedure.

There is no need for the Court to create additional checks

that have no source in the Constitution’s text, based on

speculative assumptions that public officials will misuse

lawful authority. To the contrary, as this Court has ex-

plained, Executive Branch officials are entitled to the

presumption that “they will act properly and according

to law.” FCC v. Schreiber, 381 U.S. 279, 296 (1965).

See, e.g., Fahey v. Mallonee, 332 U.S. 245, 256 (1947).

Moreover, there is little realistic possibility of abuse

of the sort that petitioners posit in this case. Petitioners’

hypothetical scenario of abuse rests on the assumption

that a single individua: exercises the rulemaking and

prosecutive functions. In reality, those functions are

earried out by separate officials: the Administrator of

the DEA exercises the authority to schedule substances

under Section 201(h) (see p. 39, infra), while the indi-

vidual United States Attorneys both possess and typically

exercise the statutory authority to initiate prosecutions.

See 28 U.S.C. 547. Thus, there is in practice a separa-

tion of the rulemaking and prosecutive functions within

the Department of Justice respecting controlled sub-

stances. The potential abuse that petitioners posit is no

more likely to occur in this case than in any case where

30

the violation of an administrative regulation may pro-

vide the basis for a criminal prosecution.*"

In any event, petitioners fail to identify any such

abuse in this case. They concede that Euphoria meets

the legisiative standards for designation as a schedule I

controlled substance, and they do not contend that the

listing of Euphoria was designed to “target|]’’ them for

prosecution. Indeed, the fact that the government lists

a controlled substance through a prospective rule of gen-

eral application all but eliminates any possibility of peti-

tioners’ hypothesized abuse. Moreover, as we explain in

greater detail below, the government’s actions are sub-

ject to judicial review at the conclusion of the perma-

nent listing and in the course of an enforcement pro-

ceeding. That review is a sufficient safeguard “against

statutory or constitutional excesses.” American Power &

Light Co. v. SEC, 329 U.S. 90, 106 (1946) .*!

4. Petitioners contend that Congress’s action in this

case is “entirely unprecedented in our history” and that

“|njo case supports” upholding the authority of the At-

torney General both to regulate legislatively identified

activity and to prosecute violation of those regulations as

a crime. Br. 19, 20. Those assertions are not accurate.

“3 While the Attorney General supervises both the U.S. Attorneys

and the DEA Administrator, it likewise can be said that the Presi-

dent supervises every agency that promulgates criminally enforce-

able regulations and also supervises the criminal enforcement of

those regulations. Thus, the potential for abuse that petitioners

posit theoretically exists in every case where a regulation may serve

as the predicate for a criminal offense.

*4 Petitioners concede (Br. 15), that Congress can combine regu-

latory and civil enforcement functions in a single agency. See, e.9.,

American Power & Light Co. v. SEC, 329 U.S. at 104-106; National

Broadcasting Co. Vv. United States, 319 U.S. at 225-226. The princi-

ple that sustains that result is equally applicable here: the executive

official acts pursuant to legislative direction, and his exercise of

discretion is subject to judicial oversight at the conclusion of the

rulemaking (see National Broadcasting Co., 319 U.S. at 198) or in

subsequent enforcement proceedings (see American Power & Light

Co., 329 U.S. at 96, 105-106).

31

Congress has granted and the courts have uniformly up-

held the Attorney General’s authority to list drugs per-

manently as controlled substances.** In addition, Con-

gress long has authorized the Attorney General to iden-

tify prohibited prison contraband and prosecute persons

who introduce it into prison. 18 U.S.C. 1791, 4001.

Prior to 1984, Section 1791 provided that:

Whoever, contrary to any rule or regulation promul-

gated by the Attorney General, introduces or at-

tempts to introduce into or upon the grounds of any

Federal penal or correctional institution or takes or

attempts to take or send therefrom any thing what-

soever, shall be imprisoned not more than ten years.

18 U.S.C. 1791 (1982). The courts uniformly upheld the

constitutionality of that statute, which in petitioners’

terminology combined “crime-defining and crime-prose-

cuting authority” (Br. 19). See S. Rep. No. 225, supra,

at 380 n.1.°° Congress amended that statute in 1984 to

ensure that the statute would reach possession as well as

introduction of contraband. See id. at 380. Congress's

delegation to the Attorney General under the past and

25 See, e.g., United States vy. Alexander, 673 F.2d 287 (Sth Cir.),

cert. denied, 459 U.S. 876 (1982); United States v. Barron, 594

F.2d 1345 (10th Cir.), cert. denied, 441 U.S. 951 (1979); United

States v. Gordon, 580 F.2d 827 (5th Cir.), cert. denied, 439 U.S.

1051 (1978); United States v. Roya, 574 F.2d 386 (7th Cir.), cert.

denied, 439 U.S. 857 (1978); United States v. Pastor, 557 F.2d 930

(2d Cir. 1977). The statutory criteria governing a Section 201(h)

temporary scheduling are as specific as—and the penalties for viola-

tions are no more stringent than—those governing permanent

scheduling.

26 See, e.g., United States v. Koopmans, 757 F.2d 901 (7th Cir.

1985); United States v. Chatman, 538 F.2d 567 (4th Cir. 1976);

United States Vv. Park, 521 F.2d 1381 (9th Cir. 1975); United

States Vv. Berrigan, 482 F.2d 171 (3d Cir. 1973); Carter v. United

States, 333 F.2d 354 (10th Cir. 1964).

32

present versions of 18 U.S.C. 1791 is at least as broad

as that under Section 201 (h).*?

C. Congress Has Provided Constitutionally Adequate

Judicial Oversight Of Section 201(h) Scheduling

Decisions

Petitioners also contend that Section 201(h) is an un-

lawful delegation because Congress has failed to set out

adequate provisions for judicial review of temporary

scheduling decisions. Petitioners’ argument, however,

rests in large part on a misunderstanding of Section

201th).

1. As petitioners recognize, the Controlled Substances

Act provides for judicial review of permanent scheduling

decisions following the issuance of a final rule. CSA

§$ 507, 21 U.S.C. 877.°* Thus, the Attorney General’s de-

cision to list a substance on schedule I is subject to judi-

cial review under Section 507 if the substance is perma-

nently listed—a process that must be completed within 15

months of the temporary listing. See CSA § 201(h) (2).

Petitioners object that Congress, through Section 201

(h) (6), has precluded Section 507 judicial review dur-

ing the period of up to 18 months that the temporary

*7 As another example, Congress has granted the Attorney Gen-

eral rulemaking authority respecting aliens and nationality, 8 U.S.C.

1103(a), and violation of such regulations may be the predicate for

criminal enforcement, see 8 U.S.C. 1324(a).

“8 Section 507 of the Controlled Substances Act specifically states

that “any person aggrieved by a final decision of the Attorney

General may obtain review of the decision in the United States

Court of Appeals for the District of Columbia or for the circuit in

which his principal place of business is located.” 21 U.S.C. 877.

That provision grants a person the right to seek review of a

final determination to list a substance permanently on one of the

controlled substances schedules. See, e.g., Grinspoon Vv. DEA, 828

F.2d 881 (1st Cir. 1987); Reckitt & Colman, Ltd. v. DEA, 788 F.2d

22 (D.C. Cir. 1986).

33

listing is in effect. See 2i U.S.C. 811(h) (6). Section

201(h) (6), however, is simply designed to postpone suits

challenging the listing decision until the administrative

process has run its course. A temporary listing of a sub-

stance under Section 201(h) is the first step in the

process of determining whether the substance should be

permanently listed on a controlled substances schedule.

The Attorney General’s basis for listing the substance

temporarily is open to public comment and reconsidera-

tion in the course of the Section 201(a) rulemaking for

permanent listing. During that rulemaking, the Attor-

ney General may decide that the substance should be

listed on a different schedule or not listed at all. Hence,

judicial review of the temporary listing decision prior to

completion of the rulemaking would be premature and

might prove entirely unnecessary.”

2. Petitioners nevertheless contend that Section 201

(h) is an unconstitutional delegation of authority be-

cause Section 201(h)(6) denies them an opportunity,

pending the permanent listing decision, to have a court

*° Cf. McGee v. United States, 402 U.S. 479, 483 (1971) (noting

that recourse to the administrative process may cure or render moot

the defects later complained of in court). The House Committee on

the Judiciary explained that the limitation on judicial review in

Section 201(h) (6) “conforms to the general practice for temporary,

emergency orders such as this procedure.” H.R, Rep. No. 835, supra,

at 13. For example, the Toxic Substances Control Act provides that

a rule respecting toxic substances may be made immediately effec-

tive for the interim period between its proposal in the Federal

Register and final action on the proposal if activities respecting the

substance are “likely to result in an unreasonable risk of serious

or widespread injury to health or the environment” and immediate

effectiveness of the rule “is necessary to protect the public interest.”

15 U.S.C. 2605(d)(2)(A). Such emergency rules “shall not, for

purposes of judicial review, be considered final agency action.”

Ibid. Similarly, the FDA may issue an immediate ban on a danger-

ous medical device if the device “presents an unreasonable, direct,

and substantial danger to the health of individuals,” 21 U.S.C.

360f(b), and such a temporary regulation is not subject to judicial

review until it has been finaiized after completed rulemaking pro-

ceedings, 21 U.S.C. 360g(a) (5).

34

‘“ ‘ascertain whether the will of Congress has been

obeyed.’” Br. 24, quoting Skinner, 490 U.S. at 218. It

is far from clear that this challenge, even if sustained,

would warrant reversal of their convictions.“” In any

event, however, Section 201(h) (6) does not foreclose ju-

dicial oversight of the Attorney General’s action during

that period. As the court of appeals properly recognized,

an individual who is prosecuted for a drug violation

based on a temporarily listed substance may challenge

the legality of the temporary listing as a defense to the

prosecution. J.A. 33 n.2, 42-43.

Under the principle of sovereign immunity, an indi-

vidual has no general right to bring a lawsuit against

the government challenging sovereign action. See, ¢.¢.,

Larson v. Domestic & Foreign Commerce Corp., 337

U.S. 682 (1949).*' Nevertheless, Congress frequently au-

thorizes individuals to bring suits against the govern-

ment (or its officers)—as in Section 507 of the Con-

trolled Substances Act—to review such action at an ap-

propriate time. See also, ¢.g., Administrative Procedure

Act, 5 U.S.C. 701 et seq. (permitting review of final

agency action). The presence or absence of a provision

creating a right to seek judicial review of agency action,

however, generally does not prevent an individual from

© Petitioners did not seek review of the Attorney General's

scheduling decision either during or after completion of the perma-

nent rulemaking, nor do they argue that Euphoria was improperly

listed as a Schedule I substance. See J.A. 33. Thus, Section

201(h) (6)’s preclusion of judicial review did not affect them in any

way. For that reason it is questionable whether petitioners have

standing to challenge the constitutionality of that provision. Even

if they have standing, petitioners would be entitled to reversal of

their convictions based on their challenge to the effect of Section

201(h) (6) only if that paragraph were deemed non-severable from

the remainder of the subsection. See 28 U.S.C. 2111.

31 See generally Cramton, Nonstatutory Review of Federal Ad-

vinistrative Action: The Need For Statutory Reform of Sovereign

Ti munity, Subject Matter Jurisdiction, Ard Parties Defendant, 68

Mich. L. Rev. 387 (1970) (describing the evolution of sovereign

immunity and its exceptions).

35

challenging agency regulations or administrative deter-

minations as a defense to a criminal action brought to

enforce them.”

While Section 201(h)(6) postpones an_ individual’s

right to seek judicial review of a listing decision under

Section 507, it does not affect the individual’s right to

challenge the listing as a defense to a criminal enforce-

ment action brought during the period that the drug was

temporarily listed as a schedule I substance. As peti-

tioners acknowledge (Br. 27), there is a strong presump-

tion favoring judicial oversight of agency action.** When

Congress wishes to prevent judicial inquiry into agency

action in an enforcement proceeding, it typically makes

‘hat wish explicit.** There is no clear indication in the

* See, ¢.9., Boyce Motor Lines, Inc. v. United States, 342 U.S.

7 1952) (eriminal enforcement of an ICC regulation); Estep v.

» ted States, 327 U.S. 114 (1946) (criminal enforcement of Selec-

» Service designation) ; Monongahela Bridge Co. v. United States,

»°a (criminal enforcement of the Secretary of War’s determination

that a bridge obstructed navigation); Union Bridge Co. v. United

States, supra (same). The APA also incorporates that general rule,

providing that “[e]xcept to the extent that prior, adequate, and ex-

clusive opportunity for judicial review is provided by law, agency

action is subject to judicial review in civil or criminal proceedings

for judicial enforcement,” 5 U.S.C. 703. That provision simply

“restates existing law.” U.S. Dep't of Justice, Attorney General’s

Manual on the Administrative Procedure Act 99 (1947). See also

Administrative Procedure in Government Agencies, S. Doc. No. 8,

77th Cong., Ist Sess. 115 (1941).

33 See McNary v. Haitian Refugee Center, Inc., No. 89-1332, slip.

op. 16 (Feb. 20, 1991) (it “is presumable that Congress legislates

with knowledge of * * * our well-settled presumption favoring

interpretations of statutes that allow judicial review of administra-

tive action”). See also, e.g., Bowen Vv. Michigan Academy of Family

Physicians, 476 U.S. 667, 670 (1986) ; Califano v. Sanders, 430 U.S.

99, 109 (1977); Dunlop v. Bachowski, 421 U.S. 560, 567 (1975);

Johnson V. Robison, 415 U.S. 361, 373-374 (1974).

4 See, e.g., Clean Air Act, § 307(b) (2), 42 U.S.C. 7607(b) (2)

(providing that EPA action that is reviewable under Section

307(b) (1) “shall not be subject to judicial review in civil or crimi-

nal proceedings for enforcement”).

36

Controlled Substances Act or its legislative history that

Congress intended to withdraw that right here. Rather,

it is clear from the structure of the statute that Section

201(h)(6)’s limitation on “judicial review,” 21 U.S.C.

811(h) (6), pertains only to the remedy that Congress

provided in Section 507, allowing aggrieved parties to

seek “judicial review.” 21 U.S.C. 877. No court has

held, as petitioners would have it, that Section 201(h)

(6) precludes an individual from challenging a tempo-

rary scheduling decision as a defense to a prosecution.

Petitioners’ argument accordingly is without merit.”

3. Petitioners contend (Br. 28-30) that even if judi-

cial review of a Section 201(h) scheduling order is avail-

able in an enforcement proceeding, the statutory scheme

is unconstitutional because it does not provide for a pre-

enforcement challenge to the validity of the administra-

tive determination. It is well settled, however, that the

Constitution does not require “that there be judicial in-

quiry before discretion can be exercised.” Ewing Vv.

Mytinger & Casselberry, Inc., 339 U.S. 594, 598-599

35 In other contexts, this Court has been unwilling to deny judicial

inquiry into the legality of an administrative regulation in a crimi-

nal enforcement proceeding where Congress has not unambiguously

precluded such inquiry. For example, in Estep v. United States,

827 U.S. 114 (1946), this Court held that a draftee who faced

criminal prosecution for refusing to submit to military induction

could raise the defense that the draft board’s actions were lawless

and outside its jurisdiction, despite a statutory provision rendering

the decisions of the local draft boards “final” except for available

administrative review. The Court stated that courts presumptively

have the power to review administrative action when exercising “the

general jurisdiction which Congress has conferred upon them.”

Id. at 119-120. Although noting that “except when the Constitution

requires it, judicial review of administrative action may be granted

or withheld as Congress chooses,” ibid., the Court stated that it

would not “readily infer that Congress departed so far from the

traditional concepts of a fair trial when it made the actions of the

local boards ‘final’ as to provide that a citizen of this country should

go to jail for not obeying an unlawful order of an administrative

agency,” id. at 122. See also Adamo Wrecking Co. v. United States,

434 U.S. 275, 285 (1978) (interpreting Clean Air Act § 307(b) (2) ).

37

(1950)."° Congress can and frequently does deny pre-

enforcement review of regulatory actions.*

Petitioners cite no case holding that pre-enforcement

review of administrative determinations is constitution-

ally required. As petitioners recognize (Br. 33), this

Court has upheld Congress’s power to restrict pre-en-

forcement review, even where important liberty interests

are at stake. For example, in Clark v. Gabrie!, 393 U.S.

256 (1968), this Court held that pre-enforcement review

of a military induction determination was not constitu-

tionally required even though the induction determina-

tion would directly affect an individual’s liberty and dis-

obedience would result in criminal prosecution. The

Court observed that pre-induction review would result

in “litigious interruptions” of induction procedures and

concluded :

We find no constitutional objection to Congress’ thus

requiring that assertion of a conscientious objector’s

claims such as those advanced by appellee be de-

ferred until after induction, if that is the course he

chooses, whereupon habeas corpus would be an

36 In Ewing, the Court rejected a manufacturer’s claim that he

was entitled under the Due Process Clause te pre-enforcement re-

view of a determination that vitamin products were misbranded and

subject to seizure, observing that “it has never been held that the

hand of government must be stayed until the courts have an op-

portunity to determine whether the government is justified in in-

stituting suit in the courts.” 339 U.S. at 599. The Court observed

that if the administrative determination were subject to pre-

enforcement review, the “means which Congress provided to protect

consumers against the injurious consequences of protracted proceed-

ings would then be seriously impaired.” /d. at 601.

37 See, e.g., Witmer v. United States, 348 U.S. 375, 377 (1955)

(noting that there “is no direct judicial review” of a military induc-

tion determination). See also, e.g., APA, 5 U.S.C. 701(a) (1) (ree-

ognizing that statutes may preclude judicial review entirely);

Comprehensive Environmental Response, Compensation, and Lia-

bility Act of 1980, as amended, 42 U.S.C. 9612 (h) (precluding pre-

enforcement review of government hazardous substance clean-up

remedies); note 29, svpra.

38

available remedy, or until defense of the criminal

prosecution which would follow should he press his

objections to his classification to the point of re-

fusing to submit to induction.

393 U.S. at 258-259.

Petitioners attempt to distinguish Clark on _ the

grounds that ‘1) that case involved “military necessity” ;

(2) the agencies involved were required to make a large

number of individual determinations; and (3) habeas

corpus relief was available. Br. 33. None of those dis-

tinctions is persuasive. First, the government’s interest

in protecting the public from the imminent danger of

hazardous drugs, such as Euphoria, poses a “necessity”

different in kind but no less pressing in degree than

military conscription. See Ewing, 339 U.S. at 599-600.

Second, Congress’s judgment that pre-enforcement re-

view would thwart the regulatory process is equally

valid here, where there is a need for immediate regula-

tion of dangerous substances pending permanent rule-

making. /d. at 601. Third, there is no need for habeas

corpus relief in the present case because the Attorney

General’s regulatory action—which prohibits the sale of

an imminently hazardous substance for a maximum of 18

months, pending completion of formal rulemaking—does

not directly result in a deprivation of liberty.

Petitioners fail to identify any substantial liberty in-

terest that would be served by pre-enforcement review.

Petitioners principally contend that pre-enforcement re-

view is necessary to save individuals from the ‘fear and

anxiety” (Br. 28-30) of a criminal prosecution. As peti-

tioners acknowledge (Br. 34), however, pre-enforcement

review would do little to allay the apprehension of crim-

inal prosecution, because the provision of review, by

itself, would not stay the effectiveness of a scheduling

order. Rather, individuals in petitioners’ business can

avoid that “fear and anxiety” of criminal prosecution

by curtailing their distribution of substances that the

39

government has determined to be hazardous during the

period of temporary regulation, presenting their chal-

lenges to the government’s determination in the rule-

making proceedings, and then (if necessary) seeking

judicial review of the permanent listing. Thus, the in-

dividuals affected by the Attorney General’s temporary

scheduling decisions have an adequate judicial remedy—

one that was not available to the defendants in Clark—

for obtaining review of the administrative decision.”

II. THE ATTORNEY GENERAL LAWFULLY SUB-

DELEGATED HIS SECTION 201(h) AUTHORITY

TO THE ADMINISTRATOR OF THE DRUG EN-

FORCEMENT ADMINISTRATION

Petitioners also contend (Br. 35-38) that their con-

victions should be reversed because the Attorney Gen-

eral unlawfully delegated his authority to schedule con-

trolled substances under Section 201(h) te the Admin-

istrator of the DEA. See 28 C.F.R. 0.100(b).* Peti-

tioners do not argue that there is any constitutional im-

pediment to that subdelegation, nor do they argue that

38 As the record in this case indicates, parties who distribute

drugs illicitly are not likely in any event to avail themselves of pre-

enforcement judicial review. Petitioners have not questioned the

merits of the government’s decision to schedule Euphoria. They did

not submit comments in the Section 201(a) or the Section 201 (h)

rulemakings respecting the drug, and they have never pretended to

be legitimate drug manufacturers or distributors.

39 The Attorney General’s subdelegation reyulation provides that

“'t}he following-described matters are assigned to, and shall be

conducted, handled, or supervised by, the Administrator of the Drug

Enforcement Administration” :

(b) Functions vested in the Attorney General by the Com-

prehensive Drug Abuse Prevention and Control Act of 1970,

as amended. This will include functions which may be vested

in the Attorney General in subsequent amendments to the

Comprehensive Drug Abuse Prevention and Control Act of

1970, and not otherwise specifically assigned or reserved by him.

28 C.F.R.0.100(b).

4

40

the delegation regulation itself is deficient in any re-

spect. Petitioners contend only that Congress has not

empowered the Attorney General to subdelegate his au-

thority under Section 201‘h). In fact, Congress has

clearly authorized that subdelegation of authority.

1. Two relevant statutory provisions authorize the

Attorney General to delegate his powers under Section

201(h) to the Administrator. First, Section 4(c) of

the Act of September 6, 1966, which reorganized the

Department of Justice, provides that the Attorney Gen-

eral “may from time to time make such provisions as

he considers appropriate authorizing the performance

by any other officer, employee, or agency of the Depart-

ment of Justice of any function of the Attorney Gen-

eral.” 28 U.S.C. 510. Second, Section 501(a) of the

Controlled Substances Act provides that the Attorney

General “may delegate any of his functions under this

subchapter to any officer or employee of the Depart-

ment of Justice.” 21 U.S.C. 871/a).° The Attorney

General’s delegation of authority to the Administrator

contained in 28 C.F.R. 0.100(b) rests squarely on those

statutory provisions. See 52 Fed. Reg. 24,447 (1987).

Petitioners speculate (Br. 35-38) that Congress in-

tended that the Attorney General’s temporary listing

authority would be nondelegable. The clear, broad, and

unqualified terms of both Section 4‘c) and Section 510,

however, unambiguously encompass the temporary list-

ing authority set forth in Section 201(h). Additionally,

Section 201(h) does not impose any liinitations on the

Attorney General’s power to subdelegate the authority

contained therein. Thus, the text of the relevant statu-

tory provisions provides no basis for the exception peti-

tioners suggest.

2. Petitioners’ suggestion that the Court create an

exception for Section 201(h) is also inconsistent with

this Court’s decisions interpreting other statutory dele-

49 That subchapter includes Sections 101 through 709 of the Con-

trolled Substances Act, 21 U.S.C. 801-904.

41

gation provisions. For example, in Fleming v. Mohawk

Wrecking & Lumber Co., 331 U.S. 111 (1947), this

Court upheld the authority of the Administrator of the

Emergency Price Control Act to delegate to district

directors his authority to issue subpoenas. That delega-

tion rested on a general provision of the statute stating

that the Administrator could appoint employees to carry

out his functions and duties under the statute and that

any duly authorized representative of the Administrator

may exercise any and all of his powers. See id. at 120-

122. The Court found no indication in the statute or in

its legislative history that Congress intended to single

out the subpoena authority as nondelegable. Jbid,**

Petitioners rely on United States v. Giordano, 416 U.S.

595 (1974), for a different result. That case, however,

supports our position. In Giordano, Congress found from

the language of the statute at issue, Title III of the Om-

nibus Crime Control and Safe Streets Act of 1968, 18

U.S.C. 2510 et seq., that Congress intended to preclude

the Attorney General from relying on his general dele-

gation authority under Section 4(c) to subdelegate his

authority to apply for a wiretap order. Section 802 of

Title III, 18 U.S.C. 2516 (1970), did not grant the At-

torney General unfettered authority to apply for a wire-

tap order, but specifically stated that the authority

rested in the “Attorney General, or any Assistant At-

41 The Court distinguished a previous decision, Cudahy Packing

Co. V. Holland, 315 U.S. 357 (1942), holding that the subpoena

authority under the Fair Labor Standards Act of 1938, ch. 676,

$ 4(b), 52 Stat. 1061-1062, did not authorize the Administrator to

delegate his power under that Act to sign and issue subpoenas. The

Court observed that the legislative history of the Act revealed that

a provision authorizing subdelegation of the subpoena authority had

been eliminated from the bill in the conference committee. Fleming,

331 U.S. at 120. Moreover, the statute considered in Cudahy specifi-

cally identified the powers to yather data and to make investigations

as delegable, and therefore by implication indicated that powers not

specified were intended to be nondelegable. 331 U.S. at 121.

42

torney General specially designated by the Attorney

General.”

‘The Court accepted the proposition that the Attorney

General’s general delegation authority under Section

4ic) would permit the delegation of all functions pre-

viously or thereafter vested in the Attorney General

unless a specific provision restricted that delegation au-

thority. 416 U.S. at 512-514. The Court concluded, how-

ever, that Congress clearly expressed its intention to

supersede the Attorney General’s general delegation au-

thority by specifically identifying in Section 802 who—

in addition to the Attorney General—could authorize a

wiretap application. The Court found that “[t]his in-

terpretation of the statute is also strongly supported by

its purpose and legislative history.” Jbid.*

Petitioners do not point to anything in the Controlled

Substances Act (or its legislative history) indicating that

Congress intended to prohibit the Attorney General from

subdelegating his temporary scheduling authority. Peti-

tioners simply argue that the authority to list schedule I

substances temporarily “is both so vast and so unbridled

that congressional authority to subdelegate should be

very clear before subdelegation is permitted.” Br. 36.

As we have discussed, above, the Section 201(h) sched-

uling authority is neither vast nor unbridled. In any

event, both Giordano and Fleming indicate that Congress

need not expressly authorize subdelegation when a gen-

eral subdelegation provision exists. See Giordano, 416

U.S. at 513-514; Fleming, 331 U.S. at 121. Rather, a

restriction on subdelegation must appear in the statute

‘2 A previous version of the relevant provision that allowed delega-

tien to an officer of the Department of Justice was changed to the

enacted version in response to the specific concern that the authority

to authorize wiretap applications should be limited. 416 U.S. at 516-

517. The legislative history in other respects reflected Conyress’s

understanding that the authority to authorize wiretap applications

was to be limited to the persons identified in Section 802. See 416

U.S. at 518-522.

43

granting new authority.** There is no such restriction—

and no basis for inferring one—in this instance. Ac-

cordingly, the Attorney General lawfully delegated his

temporary listing authority (together with the perma-

nent listing authority) to the Administrator.

** On other occasions, when Congress has sought to restrict the

Attoruey General’s authority to subdelegate his powers, Congress

has specifically limited the subdelegation authority. See, e.g., 18

U.S.C. 245(a) (1) (certain prosecutions under the Civil Rights Act

of 1968 are authorized only on the certification of “the Attorney

Ceneral, the Deputy Attorney General, the Associate Attorney Gen-

eral, or any Assistant Attorney General specially designated by the

Attorney General * * * which function of certification may not be

delegated”’) ; 18 U.S.C. 1073 (prosecutions for flight to avoid prose-

cution or to avoid giving testimony may be initiated “only upon

formal approval in writing by the Attorney General, the Deputy

Attorney General, the Associate Attorney General or an Assistant

Attorney General of the United States, which function of approving

prosecutions may not be delegated”) ; 18 U.S.C. App. at 711 (§ 14)

(functions of the Attorney General under the Classified Information

Procedures Act “may be exercised by the Deputy Attorney General,

the Associate Attorney General, or by an Assistant Attorney Gen-

eral designated by the Attorney General for such purpose and may

not be delegated to any other official”). With respect to other gov-

ernment agencies, Congress likewise has frequently, and explicitly,

identified the authorities for which delegation is restricted. See,

e.g. 5 U.S.C. 3312(b), 3318(b) (4), 83504(b): 10 U.S.C. 809 (c),

1370(a) (2), 1587(d), 1622(d), 1623(c), 2304(d) (2), 2356(a),

2435(c) (2); 12 U.S.C. 3502(c): 31 U.S.C. 1344(d) (3), 3553 (e);

38 U.S.C. 5025(b) (3) (C); 40 U.S.C. 759(d) (1): 41 U.S.C. 10b-

1(e), 253(d)(2), 421(d), 423(d)(7)(B): 42 USC. 8374 (e),

8511(f), 8513(g), 8521 (ce) (4); 49 U.S.C. 322(b).

affirmed.

dt

CONCLUSION

The judgment of the court of appeals should be

tespectfully submitted.

MARCH 1991

KENNETH W. STARR

Solicitor General

ROBERT S. MUELLER, III

Assistant Attorney General

WILLIAM C. BRYSON

Deputy Soliciter General

JEFFREY P. MINEAR

Assistant to the Solicitor General

RICHARD A. FRIEDMAN

Attorney

APPENDIX A

FOOD AND DRUGS—DRUG ABUSE PREVENTION

TEMPORARY SCHEDULING TO AVOID

IMMINENT HAZARDS TO PUBLIC SAFETY

§ 201(h), 21 U.S.C. 811(h)

(1) If the ..ttorney General finds that the sched-

uling of a substance in schedule I on a temporary

basis is necessary to avoid an imminent hazard to the

public safcty, he may, by order and without regard

to the requirements of subsection (b) of this section

relating to the Secretary of Health and Human

Services, schedule such substance in schedule I if the

substance is not listed in any other schedule in sec-

tion 812 of this title or if no exemption or approval

is in effect for the substance under section 505 of the

Federal Food, Drug, and Cosmetie Act [21 U.S.C.

355]. Such an order may not be issued before the ex-

piration of thirty days from—

(A) the date of the publication by the Attorney

General of a notice in the Federal Register of the in-

tention to issue such order and the grounds upon

which such order is to be issued, and

(B) the date the Attorney General has trans-

mitted the notice required by paragraph (4).

(2) The scheduling of a substance under this sub-

section shall expire at the end of one year from the

date of the issuance of the order scheduling such sub-

stance, except that the Attorney General may, during

the pendency of proceedings under subsection (a) (1)

of this section with respect to the substance, extend

the temporary scheduling for up to six months.

(3) When issuing an order under paragraph (1),

the Attorney General shall be required to consider,

with respect to the finding of an imminent hazard to

(la)

2a

the public safety, only those factors set forth in para-

graphs (4), (5), and (6) of subsection (c) of this

section, including actual abuse, diversion from legiti-

mate channels. and clandestine importation, manu-

facture, or distribution.

(4) The Attorney General shall transmit notice of

an order proposed to be issued under paragraph (1)

to the Secretary of Health and Human Services. In

issuing an order under paragraph (1), the Attorney

General shall take into consideration any comments

submitted by the Secretary in response to a notice

transmitted pursuant to this paragraph.

(5) An order issued under paragraph (1) with

respect to a substance shall be vacated upon the con-

clusion of a subsequent rulemaking proceeding initi-

ated under subsection (a) of this section with re-

spect to such substance.

(6) An order issued under paragraph (1) is not

subject to judicial review.

3a

DEPARTMENT OF JUSTICE DRUG ENFORCEMENT

ADMINISTRATION: GENERAL FUNCTIONS

28 C.F.R. 0.100

The following-described matters are assigned to,

and shall be conducted, handled, or supervised by, the

Administrator of the Drug Enforcement Adminis-

tration:

(a) Functions vested in the Attorney General by

sections 1 and 2 of Reorganization Plan No. 1 of

1968.

(b) Functions vested in the Attorney General by

the Comprehensive Drug Abuse Prevention and Con-

trol Act of 1970, as amended. This will include func-

tions which may be vested in the Attorney General in

subsequent amendments to the Comprehensive Drug

Abuse Prevention and Control Act of 1970, and not

otherwise specifically assigned or reserved by him.

(c) Functions vested in the Attorney General by

section 1 of Reorganization Plan No. 2 of 1973 and

not otherwise specifically assigned.

5a

APPENDIX B

Scheduling Recommendation

for 4-methylaminorex

Prepared by

Drug Control Section

Office of Diversion Control

Drug Enforcement Administration

September 1988

6a

Introduction

The Drug Enforcement Administration (DEA) has

gathered information relevant to the abuse potential,

trafficking and actual abuse of 4,5-dihydro-4-methy]-5-

phenyl-2-oxazolamine (4-methylaminorex). 4-Methyl-

aminorex is an analog of aminorex, an anorectic

agent previously marketed in Europe. 4-Methylam-

inorex has appeared in the illicit drug traffic and pur-

suant to the emergency scheduling provision of the

Controlled Substances Act (CSA) (21 U.S.C. 811(h)),

was controlled by temporary placement into Schedule

I, effective October 15, 1987 (52 FR 38225). The

temporary scheduling of 4-methylaminorex expires

one year from the effective date of control unless

traditional scheduling procedures have been initiated

in accordance with 21 U.S.C. 811(a).

Clandestine synthesis of 4-methylaminorex was first

detected following seizure by Florida law enforce-

ment officials of samples purported to be “speed.” At

least two deaths have been reported as a consequence

of 4-methylaminorex abuse. Continued control of 4-

methylaminorex is critical to law enforcement initia-

tives aimed at eliminating the manufacture and dis-

tribution of a potent amphetamine-like substance.

Criteria for inclusion of a substance in Schedule I

The necessary criteria for placing a substance in

Schedule I, as set forth in 21 U.S.C. 812(b)(1) of

the CSA, are as follows:

(1) the drug or other substance has a high potential

for abuse;

(2) the drug or other substance has no currently ac-

cepted medical use in treatment in the United States;

and

7a

(3) there is a lack of accepted safety for use of the

drug or other substance under medical supervision.

Potential for abuse

The term “potential for abuse” is described in House

Report No. 91-1444 to include any or all of four ele-

ments. These elements and their applicability in de-

termining the abuse potential of 4-methylaminorex

as follows:

(A) Evidence that individuals are taking the drug

in amounts that create a hazard to their health or the

safety of the community.

One individual from Florida and another from Ten-

nessee have died as a result of 4-methylaminorex

abuse. Another individual using 4-methylaminorex

was apprehended while running down the middle of

a highway in Florida.

(B) Diversion from legitimate channels.

There is no known legitimate commercial manufac-

turer of 4-methylaminorex.

(C) Self-administration of the drug without medical

supervision.

DEA laboratories have analyzed a number of exhi-

bits and identified them as 4-methylaminorex. These

exhibits, when summed, weighed over 1000 grams.

A reasonable estimate of dosage unit weight for 4-

methylaminorex is 20 mg. Therefore, seizures to date

have amounted to over 50,000 dosage units.

(D) Evidence that the drug in question is so related

in its action to another drug or drugs that it is likely

that it will have the same potential for abuse.

The pharmacological profile of 4-methylaminorex

closely resembles that of amphetamine. In McNeil

8a

Laboratories Department of Pharmacology Report

No. 49, 4-methylaminorex is described as ‘a potent

central nervous system stimulant. The spectrum of

pharmacological actions produced by McN-822 is sim-

ilar in several respects to that produced by ampheta-

mine.” The report goes on to describe a number of

autonomic and behavioral effects of 4-methylaminorex

that support their conclusions regarding its stimulant

effects. In particular it was noted that 4-methyl-

aminorex (5mg kg. i.v. in dog) produced substantial

increases in mean blood pressure by way of sympath-

omimetic actions. Behavioral actions were also stud-

ied in dogs. Following doses of 1-2 mg-kg, 4-

methylaminorex administration produced signs of

restlessness, alertness, and dilated pupils and “a

period of increased coordinated motor activity follows

during which panting is clearly audible.” When the

dose was increased to 5 me kg, stereotyped behavior

(repetitive motor movemenis) predominated, fol-

lowed by seizures, loss of consciousness, respiratory

depression and death. Amphetamine was reported to

produce a similar pattern of behavioral changes in

the dog.

In a study of the sympathomimetic actions of 4-

methvlaminorex, Yelnowsky and Katz' reported that

cross tolerance of this compound with amphetamine

was observed with respect to pressor actions. Fur-

thermore they noted that, like amphetamine, 4-

methylaminorex produces its sympathomimetic ac-

tions indirectly by way of released catecholamines.

Experimental studies of the anorectic actions of 4-

methylaminorex have shown that it potently sup-

1 Yelnowsky, J. and Katz, R. Sympathomimetic actions of

cis-2-amino-4-methy]-5-phenyl-2-oxazoline, J. Pharmacol. Exp.

Therap., 141: 180-184, 1963.

9a

presses appetite in rats in a manner similar to am-

phetamine *. Authors Roszkowski and Kelley noted

in their summary that “Of the 10 drugs tested 4

were very potent: d-amphetamine, methampheta-

mine, and two oxazolines, ... McN-742... and McN-

822... .” Moreover, “ ... at effective dose levels,

all of the anorexigens display a similar degree of

central nervous system stimulation.”

Review of the Eight Factors listed in 21 U.S.C.

811(c)

(1) Actual or relative potential for abuse.

As stated above, actual abuse has been made evident

by the death of at least two individuals abusing 4-

methylaminorex. In addition, a number of other in-

dividuals have been observed and/or apprehended by

officials of the Florida Department of Law Enforce-

ment following abuse of this substance. The serious

nature of 4-methylaminorex abuse in Florida has led

to the control of this substance within the state’s

Schedule I category. In a recently published article *,

a clandestine information sheet detailing the effects

of 4-methylaminorex was quoted as saying “Potential

for Abuse Of course! People have taken considerable

overdoses... .”

2 Poos, G.I., Carson, J.R., Rosenau, J.D., Roszkowski, A.P.,

Kelley, N.M. and McGowin, J., 2-amino-5-Aryl-2-oxazolines.

Potent new anorectic agents. J. Med. Chem., 6: 266-272, 1963.

Roszkowski, A.P. and Kelley, N.M., A rapid method for

assessing drug inhibition of feeding behavior. J. Pharm. Exp.

Therap., 140: 367-374, 1963.

3D—. Inaba and L. Brewer. U4Euh. Microgram, 1987.

10a

(2) Scientific evidence of its pharmacological effects,

if known.

See section (D) under Potential for Abuse section.

(3) The state of current knowledge regarding the

drug or other substance.

Toxicity

In addition to knowledge concerning the pharma-

cological actions, a study of toxicity was conducted

by investigators at McNeil Pharmaceutical. Based

on this data, 4-methylaminorex appears to produce

toxie effects associated with the extension of its pri-

mary pharmacological action, namely central nervous

system stimulation. With increasing dosage, 4-

methylaminorex produces an over stimulation of the

centra! nervous system that leads to stereotyped motor

activity, seizure activity in the brain and associated

convulsions, respiratory failure and death. Commen-

tary from the McNeil Pharmaceutical researchers

stresses that “This compound possesses a narrow

margin of safety in the dog and should be tested

very cautiously in humans.”

It should be noted that two recent deaths have been

attributed to the abuse of 4-methylaminorex’. Anal-

yses from the Florida incident indicated the presence

of high levels of 4-methylaminorex in the blood (21.3

mg/L) and urine (12.3 mg/L) of the victim.

* Davis, F.T. and Brewster, M.E., A fatality involving

U4Euh, a cyclic derivative of phenylpropanolamine. Case

report from the Orlando Crime Laboratory, Orlando, Florida

1987. Personal communication from Ms. G. Armstrong, Naval

Investigative Service, Memphis, Tennessee, 1988.

lla

Chemistry

One of the mwst distressing properties of 4-

methylaminorex from a drug control standpoint, is

the nature of the chemical procedures involved in its

synthesis. By combining phenylpropanolamine and

cyanogen bromide in a sodium acetate buffered meth-

anol solution, one obtains high yield synthesis of 4-

methylaminorex in a single step (see Figure 1).

Br

| OH ss a *:

ZA r Z ~y NH,

NH, |

CH, CH,

Prhenylpropanolamine 4-Methylaminorex

Figure l

In terms of chemical similarity to other psychoactive

substances, 4-methylaminorex most closely resembles

the anorectic agent, aminorex. Aminorex was mar-

keted in Europe under the trade names Menocil and

Apiquel. Another substance that is chemically simi-

lar to 4-methylaminorex is the Schedule IV central

nervous system stimulant, pemoline (Cylert).

(4) Its history and current pattern of abuse.

Studies on 4-methylaminorex were reported in the

scientific literature in the early 1960’s and 1970's.

Exhibits of clandestinely produced 4-methylaminorex

have been obtained since 196. The pattern of abuse

of 4-methylaminorex appears similar to that of am-

12a

phetamine. A clandestine information sheet*® de-

scribes a large dose of 4-methylaminorex as produc-

ing “sleeplessness for three days and nights.... A

few cases of abuse by taking doses for four to six

days without sleeping have been reported.”

(5) The scope, duration and significance of abuse.

The use of emergency controls on 4-methylaminorex

may have played a role in limiting the spread of this

substance. Our best estimate of the scope of 4-

methylaminorex abuse is that most of the abuse has

taken place in Florida, California and probably Penn-

sylvania with an isolated incident in Tennessee.

(6) What, if any, risk there is to the public health.

4-Methylaminorex produces pharmacological effects

that are similar to those of amphetamine and related

stimulants. Abuse of this substance should produce

the same public health risks as those associated with

the abuse of amphetamine, methamphetamine and

other potent stimulants. The public health risks at-

tendant to the abuse of stimulants are well estab-

lished and need not be elaborated here.

(7) Its psychic or physiological dependence liability.

The pharmacological profile of 4-methylaminorex is

substantially similar to amphetamine and metham-

phetamine. Such a profile strongly suggests that

abuse of 4-methylaminorex will lead to the typical

psychic dependence profile produced by the ampheta-

mines.

*D. Inaba and L. Brewer. U4Euh. Microgram, 1987.

13a

(8) Whether the substance is an immediate precursor

of a substance already controlled under this title.

4-Methylaminorex is not an immediate precursor of

any controlled substance.

Summary

Review of the pharmacology of 4-methylaminorex in-

dicates that this substance is a potent amphetamine-

like stimulant with a low margin of safety. In the

absence of any accepted medical use of the compound,

regular control proceedings should be initiated to

place 4-methylaminorex into Schedule I of Controlled

Substances Act.

Law Enforcement Seizures of 4-Methylaminorex

Amount

Date Location Type of Action (grams)

01/06/89 Newark, N.J. Lab Seizure 102.00

01/06/89 Newark, N.J. Lab Seizure 0.44

01/06/89 Newark, N.J. Lab Seizure 0.10

11/16/87 Gainesville, FL Lab Seizure 14.00

11/16/87 Gainesville, FL Lab Seizure 0.10

11/16/87 Gainesville, FL Lab Seizure 28.20

05/01/87 Norristown, PA Lab Seizure 1000.00

01/29/88 Oakland, CA Tab Seizure 672.20

08/17/88 Montgomery Cty, IN U/C Buy 13.00

*** Total *** 1830.01

wus. GOVERNMEFT PRINTING OFFICE, 1991 2862061 20440

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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