Federal

SAFE Act

Source: Congress.gov · 6,809 words in original text

What This Bill Does

This bill creates permanent rules to control fentanyl-related substances (chemicals structurally similar to fentanyl) as Schedule I drugs. It establishes penalties for making, importing, or exporting fentanyl-related substances, and allows the government to remove or reclassify these substances if they are determined to pose less danger than other drugs. The bill also streamlines research registration requirements for scientists studying controlled substances. ##

Who It Affects

- People convicted of crimes involving fentanyl-related substances - Researchers studying fentanyl or similar controlled substances - Scientists conducting clinical drug trials and medical research - U.S. law enforcement agencies - Drug manufacturers and distributors - Prison and court systems handling previous convictions ##

Key Provisions

- Fentanyl-related substances (any chemical with specific structural modifications to fentanyl) are automatically placed in Schedule I unless exempted or listed elsewhere, meaning they are treated as highly dangerous drugs with no accepted medical use (Sec. 2) - Anyone possessing 400 grams or more of a mixture containing fentanyl faces federal penalties; anyone with 40 grams or more faces different penalties (Sec. 3) - The same quantity thresholds apply to importing or exporting fentanyl or fentanyl-related substances (Sec. 4) - If the Secretary of Health and Human Services determines a fentanyl-related substance poses less danger than Schedule V drugs (the least restrictive category), the substance can be removed from control or moved to a less restrictive schedule within 90 days (Sec. 5) - Researchers with current Schedule I or II research registration can begin research on these substances 30 days after notifying the Attorney General; researchers without prior registration can receive approval within 45 days (Sec. 7) - People previously convicted based on a substance that was later removed or reclassified can ask a court to reduce their sentence (Sec. 6) ##

What Changes

If enacted, this bill will automatically make all fentanyl-related substances illegal under federal law without requiring individual government action for each new chemical variation. Currently, the government must list drugs one-by-one. Courts will gain authority to reduce sentences for people convicted under old laws if the substance they were convicted of is later reclassified. Researchers will face simpler, faster registration processes to study these substances. The bill creates a pathway for substances to be removed from control if they are proven less dangerous, though this is unlikely given the substances involved. ##

Important Definitions

**Fentanyl-related substance:** Any chemical that can be made from fentanyl through specific modifications including changing the ring structures (the circular parts of the molecule), replacing chemical groups attached to those rings, or replacing the propionyl group (an attached chemical piece) with other similar pieces. The exact changes listed in the bill include replacement of the phenyl group, substitutions on the phenethyl group, changes to the piperidine ring, replacing the aniline ring, or replacing the N-propionyl group (Sec. 2). **Schedule I:** The most restrictive category of controlled substances, meaning the drug is illegal and has no accepted medical use (explained through reference to existing law). ##

Effective Date

Not specified in bill text. The bill requires the Attorney General to issue rules within 1 year of enactment (Sec. 8).

I 118TH CONGRESS 1ST SESSION H. R. 568 To amend the Controlled Substances Act with respect to fentanyl-related substances, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 26, 2023 Mr. PAPPAS (for himself, Mr. NEWHOUSE, Mr. TONY GONZALES of Texas, and Ms. SALAZAR) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Com- mittee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall with- in the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act with respect to fentanyl-related substances, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Save Americans from 4 the Fentanyl Emergency Act’’ or the ‘‘SAFE Act’’. 5 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 568 IH SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB- 1 STANCES. 2 Section 202(c) of the Controlled Substances Act (21 3 U.S.C. 812(c)) is amended by adding at the end of sched- 4 ule I the following: 5 ‘‘(e)(1) Unless specifically exempted or unless listed 6 in another schedule, any material, compound, mixture, or 7 preparation which contains any quantity of fentanyl-re- 8 lated substances, or which contains their salts, isomers, 9 and salts of isomers whenever the existence of such salts, 10 isomers, and salts of isomers is possible within the specific 11 chemical designation. 12 ‘‘(2) In this subsection, except as provided in para- 13 graph (3), the term ‘fentanyl-related substance’ means 14 any substance that is structurally related to fentanyl by 15 one or more of the following modifications: 16 ‘‘(A) By replacement of the phenyl portion of 17 the phenethyl group by any monocycle, whether or 18 not further substituted in or on the monocycle. 19 ‘‘(B) By substitution in or on the phenethyl 20 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21 haloalkyl, amino, or nitro groups. 22 ‘‘(C) By substitution in or on the piperidine 23 ring with alkyl, alkenyl, alkoxyl, ester, ether, 24 hydroxyl, halo, haloalkyl, amino, or nitro groups. 25 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 568 IH ‘‘(D) By replacement of the aniline ring with 1 any aromatic monocycle whether or not further sub- 2 stituted in or on the aromatic monocycle. 3 ‘‘(E) By replacement of the N-propionyl group 4 with another acyl group. 5 ‘‘(3) A substance that meets the criteria specified in 6 paragraph (2) to be considered a fentanyl-related sub- 7 stance shall not be so considered as meeting such criteria 8 if such substance— 9 ‘‘(A) is controlled by action of the Attorney 10 General pursuant to section 201; 11 ‘‘(B) is expressly listed in this schedule or an- 12 other schedule by a statutory provision other than 13 this subsection; or 14 ‘‘(C) is removed from this schedule, or resched- 15 uled to another schedule, pursuant to section 201(k). 16 ‘‘(4) The Attorney General shall publish in the Fed- 17 eral Register a list of individual substances that meet the 18 definition of fentanyl-related substances in paragraph (2) 19 within 60 days of determining such substances meet such 20 definition. The absence of a substance on any such list 21 does not negate the control status of such substance if 22 the substance meets the criteria specified in paragraph (2) 23 to be considered a fentanyl-related substance. 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 568 IH ‘‘(5) Notwithstanding any other provision of this title 1 or title III, fentanyl-related substances shall not be subject 2 to quantity-based mandatory minimum penalties pursuant 3 to subparagraph (A)(vi) or (B)(vi) of section 401(b)(1) of 4 this title or paragraph (1)(F) or (2)(F) of section 1010(b) 5 of title III.’’. 6 SEC. 3. PENALTY PROVISIONS WITH RESPECT TO 7 FENTANYL-RELATED SUBSTANCES—DOMES- 8 TIC OFFENSES. 9 Section 401(b)(1) of the Controlled Substances Act 10 (21 U.S.C. 841(b)(1)) is amended— 11 (1) in subparagraph (A), by striking clause (vi) 12 and inserting the following: 13 ‘‘(vi)(I) 400 grams or more of a mixture or sub- 14 stance containing a detectable amount of fentanyl; 15 or 16 ‘‘(II) 100 grams or more of a mixture or sub- 17 stance containing a detectable amount of any ana- 18 logue of fentanyl that is controlled in schedule I or 19 II or that is treated as a schedule I controlled sub- 20 stance pursuant to section 203(a), except for a 21 fentanyl-related substance as defined in schedule 22 I(e) of section 202(c);’’; 23 (2) in subparagraph (B), by striking clause (vi) 24 and inserting the following: 25 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 568 IH ‘‘(vi)(I) 40 grams or more of a mixture or sub- 1 stance containing a detectable amount of fentanyl; 2 or 3 ‘‘(II) 10 grams or more of a mixture or sub- 4 stance containing a detectable amount of any ana- 5 logue of fentanyl that is controlled in schedule I or 6 II or that is treated as a schedule I controlled sub- 7 stance pursuant to section 203(a), except for a 8 fentanyl-related substance as defined in schedule 9 I(e) of section 202(c);’’; and 10 (3) in subparagraph (C), by inserting ‘‘, includ- 11 ing a fentanyl-related substance as defined in sched- 12 ule I(e) of section 202(c),’’ after ‘‘a controlled sub- 13 stance in schedule I or II,’’. 14 SEC. 4. PENALTY PROVISIONS WITH RESPECT TO 15 FENTANYL-RELATED SUBSTANCES—IMPORT 16 AND EXPORT OFFENSES. 17 Section 1010(b) of the Controlled Substances Import 18 and Export Act (21 U.S.C. 960(b)) is amended— 19 (1) in paragraph (1), by striking subparagraph 20 (F) and inserting the following: 21 ‘‘(F)(i) 400 grams or more of a mixture or sub- 22 stance containing a detectable amount of fentanyl; 23 or 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 568 IH ‘‘(ii) 100 grams or more of a mixture or sub- 1 stance containing a detectable amount of any ana- 2 logue of fentanyl that is controlled in schedule I or 3 II or that is treated as a schedule I controlled sub- 4 stance pursuant to section 203(a) of the Controlled 5 Substances Act, except for a fentanyl-related sub- 6 stance as defined in schedule I(e) of section 202(c) 7 of the Controlled Substances Act;’’; 8 (2) in paragraph (2), by striking subparagraph 9 (F) and inserting the following: 10 ‘‘(F)(i) 40 grams or more of a mixture or sub- 11 stance containing a detectable amount of fentanyl; 12 or 13 ‘‘(ii) 10 grams or more of a mixture or sub- 14 stance containing a detectable amount of any ana- 15 logue of fentanyl that is controlled in schedule I or 16 II or that is treated as a schedule I controlled sub- 17 stance pursuant to section 203(a) of the Controlled 18 Substances Act, except for a fentanyl-related sub- 19 stance as defined in schedule I(e) of section 202(c) 20 of the Controlled Substances Act;’’; and 21 (3) in paragraph (3), by inserting ‘‘including a 22 fentanyl-related substance as defined in schedule 23 I(e) of section 202(c) of the Controlled Substances 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 568 IH Act,’’ after ‘‘a controlled substance in schedule I or 1 II,’’. 2 SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE- 3 LATED SUBSTANCES. 4 Section 201 of the Controlled Substances Act (21 5 U.S.C. 811) is amended by adding at the end the following 6 new subsection: 7 ‘‘(k) REMOVAL FROM SCHEDULE I OF FENTANYL- 8 RELATED SUBSTANCES.— 9 ‘‘(1) DETERMINATION RESULTING IN RE- 10 MOVAL.—If the Secretary determines, taking into 11 consideration factors as set forth in paragraph (3), 12 that a fentanyl-related substance has a potential for 13 abuse that is less than the drugs or other substances 14 in schedule V— 15 ‘‘(A) the Secretary shall submit to the At- 16 torney General a scientific and medical evalua- 17 tion of that fentanyl-related substance sup- 18 porting that determination; 19 ‘‘(B) the Secretary shall submit any such 20 evaluation and determination in writing and in- 21 clude the bases therefor; 22 ‘‘(C) the scientific and medical determina- 23 tion of the Secretary contained in such evalua- 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 568 IH tion shall be binding on the Attorney General; 1 and 2 ‘‘(D) not later than 90 days after receiving 3 such evaluation and determination, the Attor- 4 ney General shall issue an order removing such 5 fentanyl-related substance from the schedules 6 under section 202. 7 ‘‘(2) DETERMINATION RESULTING IN RESCHED- 8 ULING.—If the Secretary determines, taking into 9 consideration factors as set forth in paragraph (3), 10 that a fentanyl-related substance has a potential for 11 abuse that is less than the drugs or other substances 12 in schedules I and II— 13 ‘‘(A) the Secretary shall submit to the At- 14 torney General a scientific and medical evalua- 15 tion of that fentanyl-related substance sup- 16 porting that determination; 17 ‘‘(B) the Secretary shall submit any such 18 evaluation and determination in writing and in- 19 clude the bases therefor; 20 ‘‘(C) the scientific and medical determina- 21 tion of the Secretary contained in such evalua- 22 tion shall be binding on the Attorney General; 23 and 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 568 IH ‘‘(D) not later than 90 days after receiving 1 such evaluation, the Attorney General shall 2 issue an order removing such fentanyl-related 3 substance from schedule I and controlling such 4 substance under schedule III. 5 ‘‘(3) EVALUATION FACTORS.— 6 ‘‘(A) IN GENERAL.—In making a deter- 7 mination under paragraph (1) or (2), the Sec- 8 retary— 9 ‘‘(i) shall consider— 10 ‘‘(I) the factor listed in para- 11 graph (2) of subsection (c); 12 ‘‘(II) the factors listed in para- 13 graphs (1), (3), and (6) of such sub- 14 section to the extent evidence exists 15 with respect to such factors; and 16 ‘‘(III) any information submitted 17 to the Secretary by the Attorney Gen- 18 eral for purposes of such determina- 19 tion; and 20 ‘‘(ii) may consider the factors listed in 21 paragraphs (4), (5), and (7) of subsection 22 (c) if the Secretary finds that evidence ex- 23 ists with respect to such factors. 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 568 IH ‘‘(B) CONSIDERATION OF SCIENTIFIC EVI- 1 DENCE OF PHARMACOLOGICAL EFFECT.— 2 ‘‘(i) IN GENERAL.—For the purposes 3 of subparagraph (A)(i)(I), consideration by 4 the Secretary of the results of an assess- 5 ment consisting of the studies described in 6 clause (ii) shall suffice to constitute consid- 7 eration of the factor listed in paragraph 8 (2) of subsection (c) if— 9 ‘‘(I) each such study is per- 10 formed according to scientific methods 11 and protocols commonly accepted in 12 the scientific community; and 13 ‘‘(II) the Secretary determines 14 that such assessment is adequate for 15 such purposes. 16 ‘‘(ii) DESCRIBED STUDIES.—The 17 studies described in this clause are any of 18 the following: 19 ‘‘(I) A receptor binding study 20 that can demonstrate whether the 21 substance has affinity for the human 22 mu opioid receptor. 23 ‘‘(II) An in vitro functional assay 24 that can demonstrate whether the 25 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 568 IH substance has agonist activity at the 1 human mu opioid receptor. 2 ‘‘(III) One or more in vivo ani- 3 mal behavioral studies that can dem- 4 onstrate whether the substance has 5 abuse-related drug effects consistent 6 with mu opioid agonist activity, such 7 as demonstrating similarity to the ef- 8 fects of morphine. 9 ‘‘(4) ADVANCE NOTICE REGARDING EVALUA- 10 TION AND CONCLUSION.—The Secretary shall give 11 the Attorney General at least 30 days notice before 12 sending the Attorney General an evaluation and de- 13 termination under paragraph (1) or (2) with respect 14 to a fentanyl-related substance. 15 ‘‘(5) EXCEPTION FOR TREATY OBLIGATIONS.— 16 If a fentanyl-related substance is a substance that 17 the United States is obligated to control under inter- 18 national treaties, conventions, or protocols in effect 19 on the date of enactment of the Save Americans 20 from the Fentanyl Emergency Act, this subsection 21 shall not require the Attorney General— 22 ‘‘(A) to remove such substance from con- 23 trol; or 24 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 568 IH ‘‘(B) to place such substance in a schedule 1 less restrictive than that which the Attorney 2 General determines is necessary to carry out 3 such obligations. 4 ‘‘(6) IDENTIFICATION OF FENTANYL-RELATED 5 SUBSTANCES.—If the Attorney General or any offi- 6 cial of the Department of Justice determines that a 7 substance is a fentanyl-related substance, the Attor- 8 ney General shall— 9 ‘‘(A) within 30 days of such determination, 10 notify the Secretary; and 11 ‘‘(B) include in such notification the iden- 12 tity of the substance, its structure, and the 13 basis for the determination. 14 ‘‘(7) PETITIONS FOR REMOVING A FENTANYL- 15 RELATED SUBSTANCE.— 16 ‘‘(A) IN GENERAL.—If a person petitions 17 the Attorney General to remove a fentanyl-re- 18 lated substance from schedule I(e) or to re- 19 schedule such a substance to another schedule, 20 the Attorney General shall consider such a peti- 21 tion in accordance with the procedures and 22 standards set forth in— 23 ‘‘(i) subsections (a) and (b) of this 24 section; and 25 VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 kjohnson on DSK79L0C42PROD with BILLS 13 •HR 568 IH ‘‘(ii) section 1308.43 of title 21, Code 1 of Federal Regulations (or any s [Text truncated for display. Full text available on Congress.gov.]

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