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.