USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 1 of 227
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`No 20-1376
`In the United States Court of Appeals
`for the D.C. Circuit
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`HEMP INDUSTRIES ASSOCIATION and RE BOTANICALS, INC.
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`Petitioners,
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`v.
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`UNITED STATES DRUG ENFORCEMENT ADMINISTRATION, and
`ANNE MILGRAM, in her official capacity as Administrator of the United
`States Drug Enforcement Administration,
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`Respondents.
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`PETITIONERS’ OPENING BRIEF
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`152497685.2
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`-1-
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 2 of 227
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`Matthew C. Zorn
`Yetter Coleman LLP
`811 Main St., Suite 4100
`Houston, TX 77002
`Phone: (713) 632-8000
`Fax: (713) 632-8002
`mzorn@yettercoleman.com
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`Counsel for Petitioners Hemp
`Industries Association
`
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`Shane Pennington
`Vicente Sederberg, LLP
`1115 Broadway, 12th Floor
`New York, NY 10010
`Phone: (917) 338-5455
`Fax: (303) 860-4505
`s.pennington@vicentesederberg.com
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`Shawn Hauser
`Vicente Sederberg LLP
`455 Sherman St., Suite 390
`Denver, CO 80203
`Phone: (303) 860-4501
`Fax: (303) 860-4505
`shawn@vicentesederberg.com
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`David C. Kramer
`Vicente Sederberg LLP
`633 West 5th Street, 26th Floor
`Los Angeles, CA 80203
`Phone: (303) 860-4501
`Fax: (303) 860-4505
`d.kramer@vicentesederberg.com
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`Counsel for Petitioners Hemp
`Industries Association and RE
`Botanicals, Inc.
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 3 of 227
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`CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES
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`Pursuant to Circuit Rule 28(a)(1), Petitioners Hemp Industries
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`Association and RE Botanicals, Inc. certify the following:
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`A. Parties, Intervenors, and Amici
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`1. Petitioners are Hemp Industries Association and RE Botanicals, Inc.
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`2. Respondents are:
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` The United States Drug Enforcement Administration (“DEA”)
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` Anne Milgram, in her official capacity as Administrator of DEA.
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`3. Counsel does not anticipate any party seeking leave to intervene or
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`to participate as amicus curiae in this case.
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`B. Rulings Under Review
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`DEA’s August 21, 2020, Interim Final Rule entitled “Implementation
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`of the Agriculture Improvement Act of 2018,” appears in the Federal Register
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`at 85 Fed. Reg. 51639 (Aug. 21, 2020), and is reprinted in the Joint Appendix
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`(“JA”) at JA001-007.
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`C. Related Cases
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`The petition for review now pending before this Court was not
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`previously before this Court or any other court. Petitioners filed a related
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`district court action, which Judge Boasberg dismissed on May 3, 2021. See
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`Hemp Indus. Ass’n v. United States Drug Enf’t Admin., 2021 WL 1734920
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 4 of 227
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`(D.D.C. May 3, 2021). Petitioners in this case filed a notice of appeal of that
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`ruling on May 21, 2021. The appeal was docketed as Case No. 21-5111 in this
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`Court on May 21, 2021.
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`September 28,2021
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`Respectfully submitted,
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`/s/Shane Pennington
`Shane Pennington
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 5 of 227
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`RULE 26.1 DISCLOSURE STATEMENT
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`Pursuant to Rule 26.1 of the Federal Rules of Appellate Procedure and
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`Circuit Rule 26.1, Petitioner Hemp Industries Association states that it is a
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`non-profit trade group that represents hemp companies and researchers in
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`the United States and Canada. It does not have any parent companies,
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`subsidiaries, or affiliates that have issued shares to the public.
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`Petitioner RE Botanicals, Inc. states that it is a privately held company
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`and does not have any parent companies, subsidiaries, or affiliates that have
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`issued shares to the public.
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`September 28,2021
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`Respectfully submitted,
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`/s/ Shane Pennington
` Shane Pennington
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 6 of 227
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`STATEMENT REGARDING ORAL ARGUMENT
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`Petitioners request that the Court set this case for oral argument. This
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`case involves important questions of administrative law presented within the
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`context of a complex statutory scheme. Petitioners respectfully submit that
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`this Court’s disposition of this case could be aided by oral argument.
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 7 of 227
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`TABLE OF CONTENTS
`Certificate as to Parties, Rulings, and Related Cases .................................... 3 
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`Parties, Intervenors, and Amici ........................................ 3 
`A. 
`Rulings Under Review ...................................................... 3 
`B. 
`Related Cases .................................................................... 3 
`C. 
`Rule 26.1 Disclosure Statement .................................................................... 5 
`
`Statement Regarding Oral Argument ........................................................... 6 
`
`Table of Contents ............................................................................................ 7 
`
`Table of Authorities ...................................................................................... 10 
`
`Glossary ........................................................................................................ 15 
`
`Jurisdictional Statement .............................................................................. 16 
`
`Statement of the Issues ................................................................................ 19 
`
`Statutes and Regulations .............................................................................. 19 
`
`Statement of the Case ................................................................................... 19 
`
`I. 
`
`STATUTORY AND REGULATORY BACKGROUND ......................................... 19 
`
`A. 
`
`The Controlled Substances Act And The Single
`Convention ....................................................................... 19 
`B.  DEA REGULATION OF CANNABIS SATIVA L. AND
`RELATED SUBSTANCES ....................................................... 23 
`The 2018 Farm Bill ......................................................... 28 
`C. 
`PROCEDURAL HISTORY ......................................................................... 32 
`
`II. 
`
`Summary of Argument ................................................................................ 32 
`
`Standing ....................................................................................................... 34 
`
`Argument ..................................................................................................... 35 
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 8 of 227
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`I. 
`
`THE INTERIM FINAL RULE IS ARBITRARY, CAPRICIOUS, OR
`OTHERWISE CONTRARY TO LAW. ........................................................... 35 
`
`A. 
`B. 
`
`Standard Of Review ........................................................ 35 
`The 2018 Farm Bill Does Not Greenlight Treaty
`Violations. ....................................................................... 36 
`The 2018 Farm Bill Does Not Augment DEA’s
`Regulatory Authority. ..................................................... 46 
`II.  DEA ISSUED THE INTERIM FINAL RULE WITHOUT OBSERVANCE OF
`PROCEDURE REQUIRED BY LAW. ........................................................... 49 
`
`C. 
`
`C. 
`
`A. 
`B. 
`
`Standard Of Review ........................................................ 49 
`The Controlled Substances Act Requires Formal
`Rulemaking Or Direct Final Order For Scheduling
`Decisions. ........................................................................ 49 
`The Interim Final Rule Should Be Invalidated
`Because It Is A Scheduling Decision Promulgated
`Without Observance Of The Procedures § 811
`Requires. .......................................................................... 51 
`III.  DEA DID NOT DEMONSTRATE GOOD CAUSE TO DISPENSE WITH
`NOTICE AND COMMENT OR THE APA-REQUIRED 30-DAY GRACE
`PERIOD. ............................................................................................... 53 
`
`Standard Of Review ........................................................ 53 
`A. 
`B.  DEA Did Not Demonstrate Good Cause To Dispense
`With Notice And Comment. ........................................... 54 
`C.  DEA Has Not Demonstrated Good Cause For
`Making The Interim Final Rule Effective
`Immediately. ................................................................... 59 
`IV.  THE INTERIM FINAL RULE IS VOID UNDER THE FEDERAL VACANCIES
`REFORM ACT. ....................................................................................... 60 
`
`A. 
`B. 
`
`Standard Of Review ........................................................ 60 
`Shea Served As Acting Administrator Long Past
`§ 3346’s Time Limit. ....................................................... 60 
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 9 of 227
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`C. 
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`Shea Was Not Eligible To Serve As Acting
`Administrator Under § 3345 of the Federal
`Vacancies Reform Act. ..................................................... 61 
`Promulgating The Interim Final Rule Was A
`Function Or Duty Of The DEA Administrator. .............. 62 
`Conclusion ................................................................................................... 64 
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`D. 
`
`Certificate of Compliance ............................................................................ 66 
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`Certificate of Service .................................................................................... 67 
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 10 of 227
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`TABLE OF AUTHORITIES1
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`Cases
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`Ass’n of Private Sector Colls. & Univs. v. Duncan
` 681 F.3d 427 (D.C. Cir. 2012) .................................................................... 34
`
`Birckhead v. Federal Energy Regulatory Commisssion
` 925 F.3d 510 (D.C. Cir. 2019) ................................................................... 35
`
`Bonacci v. TSA
` 909 F.3d 1155 (D.C. Cir. 2018) .................................................................. 34
`
`Brown v. Sessoms
` 774 F.3d 1016 (D.C. Cir. 2014) .................................................................. 53
`
`Chamber of Commerce v. OSHA
` 636 F.2d 464 (D.C. Cir. 1980) ................................................................... 55
`
`Comm. of U.S. Citizens Living in Nicaragua v. Reagan
` 859 F.2d 929 (D.C. Cir. 1988) ................................................................... 37
`
`F.C.C. v. Fox Television Stations, Inc.
` 556 U.S. 502 (2009) .................................................................................. 45
`
`Fry v. United States Drug Enf’t Admin.
` 353 F.3d 1041 (9th Cir. 2003) .................................................................... 16
`
`Fund for Animals, Inc. v. Kempthorne
` 472 F.3d 872 (D.C. Cir. 2006) ................................................................... 32
`
`Gregory v. Ashcroft
` 501 U.S. 452 (1991) .................................................................................... 38
`
`*Hemp Indus. Ass’n v. United States Drug Enf’t Admin. (“Hemp I”)
` 333 F.3d 1082 (9th Cir. 2003) ....................................... 24-25,46-49, 51-53
`
`*Hemp Indus. Ass’n v. United States Drug Enf’t Admin. (“Hemp II”)
` 357 F.3d 1012 (9th Cir. 2004) ............................................. 25, 46-49, 51-53
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`Hemp Indus. Ass’n v. United States Drug Enf’t Admin.
` 2021 WL 1734920 (D.D.C. May 3, 2021) .............................................. 4, 35
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`Authorities upon which we chiefly rely are marked with asterisks.
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`1
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`10
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 11 of 227
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`John Doe, Inc. v. United States Drug Enf’t Admin.
` 484 F.3d 561 (D.C. Cir. 2007) .................................................................... 16
`
`L.M.-M. v. Cuccinelli
` 442 F. Supp. 3d 1 (D.D.C. 2020) ............................................................... 62
`
`Lujan v. Defenders of Wildlife
` 504 U.S. 555 (1992) .................................................................................. 34
`
`McCulloch v. Sociedad Nacional de Marineros de Honduras
` 372 U.S. 10 (1963) ..................................................................................... 38
`
`MCI Telecommc’ns Corp. v. FCC
` 57 F.3d 1136 (D.C. Cir. 1995) ............................................................... 49, 55
`
`Merck & Co. v. Reynolds
` 559 U.S. 633 (2010) .................................................................................. 49
`
`Motor Vehicle Mfrs. Ass’n, Inc. v.State Farm Mut. Auto. Ins. Co.
` 463 U.S. 29 (1983) ...................................................................................... 31
`
`Murray v. The Charming Betsy
` 2 Cranch 64 (1804) .................................................................................... 37
`
`Nat’l Ass’n of Home Health Agencies v. Schweiker
` 690 F.2d 932 (D.C. Cir. 1982) ................................................................... 55
`
`Nat’l Nutritional Foods Ass’n v. Kennedy
` 572 F.2d 377 (2d Cir. 1978) ....................................................................... 58
`
`Nat’l Weather Serv. Emps. Org. v. Fed. Lab. Relations Auth., 966
`F.3d 875 (D.C. Cir. 2020)…………………………. ........................................... 45
`
`
`Nutt v. United States Drug Enf’t Admin.
` 916 F.2d 202 (5th Cir. 1990) ...................................................................... 16
`
`Owner-Operator Indep. Drivers Ass'n, Inc. v. Fed. Motor Carrier
`Safety Admin.
` 494 F.3d 188(D.C. Cir. 2007) .................................................................... 49
`
`*Roeder v. Islamic Republic of Iran (“Roeder I”)
` 333 F.3d 228 (D.C. Cir. 2003) .......................................... 37, 38, 39, 42, 43
`
`*Roeder v. Islamic Republic of Iran (“Roeder II”)
` 646 F.3d 56 (D.C. Cir. 2011)……………. .......................................... 37, 38, 43
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 12 of 227
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`
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`Sierra Club v. Envt’l Protection Agency
` 292 F.3d 895 (D.C. Cir. 2002) .................................................................. 34
`
`Sorenson Commcn’s Inc. v. F.C.C.
` 755 F.3d 702 (D.C. Cir. 2014) ................................................................... 53
`
`South Carolina v. Block
` 558 F. Supp. 1004 (D. S.C. 1983) .............................................................. 56
`
`Standing Akimbo, LLC v. United States
` 141 S. Ct. 2236 (2021) ................................................................................ 44
`
`State Nat’l Bank of Big Spring v. Lew
` 795 F.3d 48 (D.C. Cir. 2015) ..................................................................... 34
`
`Tenn. Gas Pipeline Co. v. Federal Energy Regulatory Commission
` 969 F.2d 1141 (D.C. Cir. 1992)) ................................................................. 52
`
`Title Guarantee Co. v. Nat’l Labor Relations Bd.
` 534 F.2d 484 (2d Cir. 1976) ...................................................................... 53
`
`Trans World Airlines v. Franklin Mint Corp.
` 466 U.S. 243 (1984)) ............................................................... 32, 33, 35, 36
`
`TRW Inc. v. Andrews
` 534 U.S. 19 (2001) ..................................................................................... 45
`
`Util. Solid Waste Activities Grp. v. Envt’l Protection Agency
` 236 F.3d 749 (D.C. Cir. 2001) ............................................................. 52, 53
`
`Weinberger v. Rossi
` 456 U.S. 25 (1982) ......................................................................... 32, 33, 36
`
`Yakus v. United State
` 321 U.S. 414 (1944) ..................................................................................... 19
`Statutes
`5 U.S.C. § 551………………………….. ................................................................ 22
`5 U.S.C. § 553 ................................................................................................ 35
`5 U.S.C. § 553(b)……………………………………………….. .................. 32, 51, 56, 59
`5 U.S.C. § 553(d)……………….. ................................................................. 60, 61
`5 U.S.C. § 559……………………. ....................................................................... 22
`5 U.S.C. § 706 ............................................................................................... 50
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 13 of 227
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`5 U.S.C. § 3345………………………. ...................................................... 61, 62, 63
`5 U.S.C. § 3346…………………………… .............................................................. 61
`5 U.S.C. § 3347……………………………. ............................................................. 61
`5 U.S.C. § 3348………………………… ................................................... 61, 62, 64
`5 U.S.C. § 3349…………………… .................................................... 57, 58, 59, 60
`7 U.S.C. § 1639o ....................................................................................... 29, 31
`7 U.S.C. § 1639r………………… ...................................................... 36, 48, 49, 58
`7 U.S.C. § 5940(b)(2) .................................................................................... 29
`21 U.S.C. § 801………………………………………… .............................................. 40
`21 U.S.C. § 802(16)………………………………….. .................................. 30, 47, 48
`21 U.S.C. § 811………………………………………… .................. 34, 48, 49, 51, 52, 53
`21 U.S.C. § 811(a)……………………………………… ................ 21, 22, 23, 27, 34, 52
`21 U.S.C. § 811(c)………………………… ............................................................. 21
`21 U.S.C. § 811(d)(1)…………………………………… .... 21, 22, 27-29, 44-45, 51-52
`21 U.S.C. § 811(h)……………………………………….. ........................................... 22
`21 U.S.C. § 812…………………………………………… ................... 20, 21, 24, 30, 48
`21 U.S.C. § 826………………………………………. ................................................ 27
`21 U.S.C. § 841…………………………. ................................................................ 19
`21 U.S.C. § 871 ........................................................................................ 18, 63
`21 U.S.C. § 877 .................................................................................... 17, 18, 19
`28 U.S.C. § 1605 ..................................................................................... 42, 43
`44 U.S.C. § 307 .............................................................................................. 19
`Regulations and Other Authorities
`21 C.F.R. § 1308.03……………………………… ................................................... 27
`21 C.F.R. § 1308.11(d) ...................................................... 25, 26, 27, 32, 47, 53
`21 C.F.R. § 1308.15……………………………… .............................................. 29, 32
`21 C.F.R. § 1312.30………………………………… ........................................... 29, 32
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 14 of 227
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`28 C.F.R. § 0.100 ............................................................................... 19, 64, 65
`28 C.F.R. § 0.104 .......................................................................................... 65
`66 Fed. Reg. 51530 (Oct. 9, 2001)………………. ............................................. 24
`68 Fed. Reg. 14113 (Mar. 21, 2003) .............................................................. 25
`83 Fed. Reg. 48950 (Sept. 28, 2018) ................................... 28, 33, 37, 44, 53
`81 Fed. Reg. 90194 (Dec. 14, 2016) ........................................................ 26, 27
`85 Fed. Reg. 82333 (Dec. 18, 2020) ....................................................... 46, 64
`D.C. Cir. R. 25(a) .......................................................................................... 18
`D.C. Cir. R. 25(c)(3)…………………………… ..................................................... 18
`D.C. Cir. R. 25(f)……………………………….. ................................................ 18, 19
`D.C. Cir. R. 28(a)(1)……………………….. ........................................................... 3
`Fed. R. App. P. 15(a)(1) .................................................................................. 17
`Fed. R. App. P. 20. ........................................................................................ 18
`Fed. R. App. P. 25(a)(2)(B) .......................................................................... 18
`Fed. R. App. P. 26.1…………………………. .......................................................... 5
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` 19
`
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`Black’s Law Dictionary (11th ed. 2019)……………………………..
`Clarification of the New Drug Code (7350) for Marijuana Extract,
`https://www.deadiversion.usdoj.gov/schedules/marijuana/m_extr
`act_7350.html......................................... ............................................ 28, 47
`Internal Directive Regarding the Presence of Cannabinoids in
`Products and Materials Made from the Cannabis Plant (May 22,
`2018),
`https://www.deadiversion.usdoj.gov/schedules/marijuana/dea_int
`ernal_directive_cannabinoids_05222018.html...................... .... 26, 47, 53
`Report, Cannabis and Cannabinoids for Medical, Scientific and
`“Recreational” Use: Risks and Benefits(2018) ........................................ 45
`Single Convention, 18 U.S.T. 1407……………………… .............................. 23, 24
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 15 of 227
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`GLOSSARY
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`Administrative Procedure Act
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`United States Drug Enforcement Administration
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`United States Food and Drug Administration
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`APA
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`DEA
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`FDA
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`FDCA
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`Federal Food, Drug, and Cosmetic Act
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`HHS
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`United States Department of Health and Human Services
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`JA
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`Joint Appendix
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`USDA United States Department of Agriculture
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 16 of 227
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`JURISDICTIONAL STATEMENT
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`DEA published the Interim Final Rule in the Federal Register on
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`August 21, 2020. JA001. Twenty-eight days later, petitioners filed their
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`petition for review in this Court. See Pet. for Rev. 2. This Court has
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`jurisdiction under 21 U.S.C. § 877.
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`In an order setting the briefing schedule in this case and two others,
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`this Court directed petitioners in their opening brief to address whether the
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`petition for review was timely filed “within thirty days after notice of the
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`decision.” Order (July 27, 2021) (citing 21 U.S.C. § 877; John Doe, Inc. v.
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`United States Drug Enf’t Admin., 484 F.3d 561, 568-70 (D.C. Cir. 2007); Fry
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`v. United States Drug Enf’t Admin., 353 F.3d 1041, 1044 (9th Cir. 2003);
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`Nutt v. United States Drug Enf’t Admin., 916 F.2d 202, 203 (5th Cir. 1990)).
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`The discussion that follows demonstrates that it was.
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`Federal Rule of Appellate Procedure 15(a)(1) requires that petitions for
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`review of agency action be filed “with the clerk of a court of appeals
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`authorized to review the agency order” “within the time prescribed by law.”
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`Fed. R. App. P. 15(a)(1). Here, § 507 of the Comprehensive Drug Abuse
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`Prevention and Control Act of 1970 (the “Controlled Substances Act”), Pub.
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`Law 91-513, 84 Stat. 1236, provides that
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`All final determinations, findings, and conclusions of the
`Attorney General under this [subchapter I of the Act] shall be
`final and conclusive decisions of the matters involved, except
`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 … upon petition
`filed with the court and delivered to the Attorney General within
`thirty days after notice of the decision.
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`21 U.S.C. § 877 (emphasis added).
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`DEA published the Interim Final Rule in the Federal Register on
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`August 21, 2020. JA001. Federal Rule of Appellate Procedure 20 provides
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`that Rule 25 applies to petitions for review of agency action, and thus Rule
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`25(a) governs the definition of “filing.” Fed. R. App. P. 20.
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`Rule 25(a)(2)(B) requires represented persons to file electronically
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`“unless nonelectronic filing is allowed by the court for good cause or is
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`allowed or required by local rule.” Fed. R. App. P. 25(a)(2)(B). D.C. Circuit
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`Rule 25(a) mandates that “all documents must be filed electronically in
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`accordance Rule 25.” D.C. Cir. R. 25(a). D.C. Circuit Rule 25(c)(3) addresses
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`“[c]ase-initiating documents,” including “petitions for review” of “agency
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`action” in particular,” and provides that they “may be filed either
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`electronically or in paper form.” D.C. Cir. R. 25(c)(3).
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`Petitioners filed the petition for review electronically on September 18,
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`2020. That filing prompted a “Notice of Docket Activity” generated by this
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`Court’s CM/ECF system, which, under D.C. Circuit Rule 25(f), “constitute[d]
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 18 of 227
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`service of the filed document on all parties who have consented to electronic
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`service.” D.C. Cir. R. 25(f). Petitioners’ counsel also certified that a “copy of
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`the Petition was served on all counsel of record, as listed below, via Federal
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`Express” on September 18, 2020. See Pet. for Rev. 8.
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`Petitioners had constructive notice of the Interim Final Rule when
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`DEA published it in the Federal Register on August 21, 2020. See Yakus v.
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`United States, 321 U.S. 414, 435 (1944) (citing 44 U.S.C. § 307). Accordingly,
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`21 U.S.C. § 877 required them to file their petition for review in this Court
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`and deliver it to the Attorney General within “thirty days after [August 21,
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`2020].” Petitioners’ September 18, 2020, electronic filing twenty-eight days
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`after the Interim Final Rule appeared in the Federal Register was therefore
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`timely, and because that electronic filing also constituted service on
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`respondents—the Attorney General’s delegees for § 877 purposes, see 28
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`C.F.R. § 0.1002—their petition was also “delivered to the Attorney General”
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`within § 877’s thirty-day window. See Service, Black’s Law Dictionary (11th
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`ed. 2019) (defining service to mean “delivery …”).3
`
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`The Attorney General promulgated a regulation subdelegating
`2
`performance of the functions delegated to him by Congress under the
`Controlled Substances Act to the DEA Administrator. See 28 C.F.R.
`§ 0.100(b); see also 21 U.S.C. § 871(a) (permitting sub-delegation).
`Although 21 U.S.C. § 877 does not require physical delivery, petitioners
`3
`would have satisfied the statutory mandate even if it did since they had the
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 19 of 227
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`STATEMENT OF THE ISSUES
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`1. Whether the Interim Final Rule is arbitrary and capricious or
`otherwise contrary to law?
`2. Whether DEA promulgated the Interim Final Rule without observance
`of procedure required by law?
`3. Whether the Interim Final Rule is void under the Federal Vacancies
`Reform Act?
`
`STATUTES AND REGULATIONS
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`Pertinent statutes and regulations appear in the addendum.
`
`STATEMENT OF THE CASE
`
`I.
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`STATUTORY AND REGULATORY BACKGROUND
`A. The Controlled Substances Act And The Single
`Convention
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`In 1970, Congress passed the Controlled Substances Act, which
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`provides for placement of controlled substances on five different schedules.
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`See 21 U.S.C. § 812(c) (initial schedules of controlled substances).
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`Scheduling a drug makes handling it without DEA registration a federal
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`crime, and a drug’s particular placement on the schedules determines the
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`nature of the offense and the length of the sentence that may be imposed.
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`See, e.g., id. § 841 (establishing prohibited acts and penalties). The schedules
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`range from schedule I—listing substances that have a high potential for
`
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`petition for review delivered to Respondents by Federal Express on
`September 18, 2020, as well. See Pet. for Rev. 8 (certificate of service).
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`USCA Case #20-1376 Document #1915982 Filed: 09/28/2021 Page 20 of 227
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`abuse, no accepted medical use in treatment in the United States, and a lack
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`of accepted safety for use of the substance under medical supervision—to
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`schedule V—listing substances with a relatively low potential for abuse, a
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`currently accepted medical use in treatment in the United States, and abuse
`
`of which may lead to limited dependence relative to the drugs on Schedules
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`I through IV. See id. § 812(b)(1), (5). Penalties vary accordingly.
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`1.
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`Procedural requirements for scheduling decisions
`
`The Controlled Substances Act lists certain substances on each of the
`
`five schedules, but also provides that DEA can add substances to the
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`schedules, remove some, and transfer between the schedules. Id. § 811(a).
`
`The statute circumscribes DEA’s power to add substances in several respects.
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`First, it lists the factors that must be considered for each substance proposed
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`to be controlled, i.e., (1) its actual or relative potential for abuse; (2) scientific
`
`evidence of its pharmacological effect, if known; (3) the state of current
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`scientific knowledge regarding the drug or other substance; (4) its history
`
`and current pattern of abuse; (5) the scope, duration, and significance of
`
`abuse; (6) what, if any, risk there is to the public health; (7) its psychic or
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`physiological dependence liability; and (8) whether the substance is an
`
`immediate precursor of a substance already controlled under this
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`subchapter. Id. § 811(c).
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`Second, the statute requires that DEA obtain a “scientific and medical”
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`evaluation of the substance from the Secretary of the United States
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`Department of Health and Human Services (“HHS”), which is binding if the
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`Secretary recommends that DEA should not schedule the substance. Id.
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`§ 811(b). Finally, before adding a substance to the schedules, DEA must
`
`follow the formal rulemaking procedures of the Administrative Procedure
`
`Act (“APA”), codified at 5 U.S.C. §§ 551-559. See 21 U.S.C. § 811(a) (“Rules of
`
`the Attorney General under this subsection shall be made on the record after
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`opportunity for a hearing pursuant to the rulemaking procedures
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`prescribed by subchapter II of chapter 5 of title 5.”) (emphasis added).
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`Because the process of permanent scheduling is inevitably time
`
`consuming, Congress amended the Controlled Substances Act in 1984 to
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`permit the Attorney General to schedule substances on a temporary basis to
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`“avoid an imminent hazard to the public safety.” See 21 U.S.C. § 811(h)(1),
`
`(3). The Controlled Substances Act also provides for an expedited scheduling
`
`action where control is required by United States obligations under
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`international treaties, conventions, or protocols. Id. § 811(d)(1). If control is
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`required under such an international treaty, convention, or protocol, the
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`Attorney General, as delegated to the Administrator, must issue an order
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`controlling such drug under the schedule he deems most appropriate to carry
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`out such obligations, without regard to the findings or procedures otherwise
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`required for scheduling actions. Id.
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`In accordance with 21 U.S.C. § 811(d)(1), scheduling actions for drugs
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`that must be controlled to ensure compliance with United States obligations
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`under international treaties, conventions, or protocols in effect on October
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`27, 1970, must be issued by direct final order (as compared to scheduling by
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`rule under 21 U.S.C. § 811(a)).
`
`2. The Single Convention
`
`The Single Convention on Narcotic Drugs (“Single Convention”),
`
`entered into force for the United States on June 24, 1967, when the Senate
`
`gave its advice and consent to the United States’ accession. See Single
`
`Convention, 18 U.S.T. 1407. It requires parties to impose stringent controls
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`on the cultivation, manufacture, and distribution of narcotic drugs, including
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`“cannabis,” which it defines as “the flowering or fruiting tops of the cannabis
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`plant (excluding the seeds and leaves when not accompanied by the tops)
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`from which the resin has not been extracted, by whatever name they may be
`
`designated.” Single Convention art. 1(1)(b).
`
`Parties must, among other things, es