Floor SpeechNeutral2025-03-10

Text of Senate Amendment 1242

Crime & Justice

Context

On 2025-03-10, Senator Christopher A. Coons (D-DE) delivered a floor speech titled "Text Of Senate Amendment 1242" in the Senate. The speech addressed crime and justice. It referenced legislation including S1637, S1638, S331.

Full Text

Text of Senate Amendment 1242

Congressional Record, Volume 171 Issue 44 (Monday, March 10, 2025) [Congressional Record Volume 171, Number 44 (Monday, March 10, 2025)] [Senate] [Pages S1637-S1638] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] SA 1242. Mr. COONS submitted an amendment intended to be proposed by him to the bill S. 331, to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; which was ordered to lie on the table; as follows: At the appropriate place, insert the following: SEC. ___. REMOVAL FROM SCHEDULE I OF FENTANYL-RELATED SUBSTANCES. Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following: ``(k) Removal From Schedule I of Fentanyl-related Substances.-- ``(1) Determination resulting in removal from all schedules.--If the Secretary determines, taking into consideration the factors set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedule V-- ``(A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; ``(B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; ``(C) the scientific and medical matters contained in the evaluation of the Secretary shall be binding on the Attorney General; and ``(D) except as provided in paragraph (4), not later than 90 days after receiving such evaluation and determination, the Attorney General shall issue an order removing such fentanyl-related substance from the schedules under section 202. ``(2) Determination resulting in rescheduling.--If the Secretary determines, taking into consideration the factors set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedules I and II-- ``(A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; ``(B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; ``(C) consistent with subsection (b), the scientific and medical matters contained in the evaluation of the Secretary shall be binding on the Attorney General; and ``(D) except as provided in paragraph (4), not later than 90 days after receiving such evaluation and determination, the Attorney General shall issue an order removing such fentanyl-related substance from schedule I and controlling such substance under schedule III. ``(3) Evaluation factors.-- ``(A) In general.--In making a determination under paragraph (1) or (2), the Secretary-- ``(i) shall consider the factor listed in paragraph (2) of subsection (c), as established by the assessment described in subparagraph (B) of this paragraph; ``(ii) shall consider the factors listed in paragraphs (1), (3), and (6) of subsection (c); and ``(iii) may consider the factors listed in paragraphs (4), (5), and (7) of subsection (c) if the Secretary finds that evidence exists with respect to those factors. ``(B) Consideration of scientific evidence of pharmacological effect.-- ``(i) In general.--For the purposes of subparagraph (A)(i), consideration by the Secretary of the results of an assessment consisting of the studies described in clause (ii) of this subparagraph shall only suffice to constitute consideration of the factor listed in paragraph (2) of subsection (c) if-- ``(I) each such study is performed according to scientific methods and protocols commonly accepted in the scientific community; and ``(II) the Secretary determines that such assessment is adequate for such purposes. ``(ii) Described studies.--The studies described in this clause include the following: ``(I) One or more receptor binding studies that can-- ``(aa) demonstrate whether the substance has affinity for the human mu opioid receptor and assess the duration and intensity of the binding; and ``(bb) establish displacement by antagonists such as naloxone. ``(II) One or more in vitro functional assays that can demonstrate whether the substance has agonist activity at the human mu opioid receptor. ``(III) One or more in vivo animal behavioral studies that can demonstrate whether the substance has abuse-related drug effects consistent with mu opioid agonist activity, such as demonstrating similarity to the effects of morphine. ``(iii) Guidance.--Not later than 90 days after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, the Secretary shall publish guidance describing the parameters for studies that meet the criteria established under clause (ii). ``(4) Attorney general review.-- ``(A) In general.--Notwithstanding a determination by the Secretary resulting in removal or rescheduling under paragraph (1) or (2), the Attorney General may not issue an order of removal or rescheduling if, not later than 90 days after receiving the applicable evaluation and determination from the Secretary, the Attorney General finds under the processes described in subsection (h) that maintaining the scheduling of the substance is necessary to avoid an imminent hazard to the public safety. ``(B) Temporary scheduling.--Upon a finding under subparagraph (A), the substance shall be deemed temporarily scheduled for the time period described in subsection (h)(2), which may be extended as provided in that subsection. ``(C) Expiration of temporary scheduling.--Not later than 30 days after the expiration of the time period described in subparagraph (B) and any extension thereof as described in that subparagraph, the Attorney General shall issue an order to remove or reschedule the substance pursuant to the Secretary's determination unless the substance has otherwise been scheduled under the processes described in this section. ``(5) Notice from secretary to attorney general.-- ``(A) Notice of initiation of proceedings.--Not later than 30 days after the date on which the Secretary initiates proceedings to evaluate a substance under paragraph (1) or (2), the Secretary shall notify the Attorney General of the initiation of the proceedings. ``(B) Advance notice regarding evaluation and conclusion.-- Not later than 30 days before the date on which the Secretary sends the Attorney General an evaluation and determination under paragraph (1) or (2), the Secretary shall notify the Attorney General with respect to the evaluation and determination. ``(6) Exception for treaty obligations.--If a fentanyl- related substance is a substance that the United States is obligated to control under international treaties, conventions, or protocols in effect on the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, this subsection shall not require the Attorney General-- ``(A) to remove such substance from control; or ``(B) to place such substance in a schedule less restrictive than that which the Attorney General determines is necessary to carry out such obligations. ``(7) Identification of fentanyl-related substances.--If the Attorney General determines that a substance is a fentanyl-related substance, the Attorney General shall-- ``(A) not later than 30 days after the date of such determination, notify the Secretary; ``(B) include in such notification the identity of the substance, its structure, and the basis for the determination; and ``(C) as soon as practicable, publish in the Federal Register an updated list under subsection (e)(4) of schedule I that includes the fentanyl-related substance, unless good cause exists not to do so. ``(8) Petitions for transferring a fentanyl-related substance under the drug schedules.-- [[Page S1638]] ``(A) In general.--If a person petitions the Attorney General to remove a fentanyl-related substance from schedule I, to reschedule a fentanyl-related substance to another schedule, or to place a fentanyl-related substance under schedule I, the Attorney General shall consider such a petition in accordance with the procedures and standards set forth in-- ``(i) subsections (a) and (b) of this section; and ``(ii) section 1308.43 of title 21, Code of Federal Regulations (or any successor regulation). ``(B) Attorney general to inform secretary.--Not later than 30 days after the date of accepting a petition described in subparagraph (A), the Attorney General shall forward a copy of the petition to the Secretary. ``(C) Determination procedure not precluded by filing of petition.--The filing of a petition described in this paragraph shall not preclude the Secretary from making a determination and sending an evaluation under paragraph (1) or (2). ``(9) Rules of construction.--Nothing in this subsection shall be construed to preclude the Attorney General from-- ``(A) transferring a substance listed in schedule I to another schedule, or removing such substance entirely from the schedules, pursuant to other provisions of this section and section 202; or ``(B) transferring a fentanyl-related substance from a schedule other than schedule I to schedule I if information supports such a transfer. ``(10) Subsequent controlling of removed substance.--A substance removed from schedule I pursuant to this subsection may, at any time, be controlled pursuant to the other provisions of this section and section 202 without regard to the removal pursuant to this subsection. ``(11) Evaluations or studies.--The Secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances. ``(12) Annual review by secretary.-- ``(A) In general.--Not less frequently than annually, the Secretary shall review fentanyl-related substances identified under paragraph (7), including a review of available evidence and any analysis or data in the possession of the Attorney General with regard to those substances

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Text of Senate Amendment 1242 Congressional Record, Volume 171 Issue 44 (Monday, March 10, 2025) [Congressional Record Volume 171, Number 44 (Monday, March 10, 2025)] [Senate] [Pages S1637-S1638] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] SA 1242. Mr. COONS submitted an amendment intended to be proposed by him to the bill S. 331, to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; which was ordered to lie on the table; as follows: At the appropriate place, insert the following: SEC. ___. REMOVAL FROM SCHEDULE I OF FENTANYL-RELATED SUBSTANCES. Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following: ``(k) Removal From Schedule I of Fentanyl-related Substances.-- ``(1) Determination resulting in removal from all schedules.--If the Secretary determines, taking into consideration the factors set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedule V-- ``(A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; ``(B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; ``(C) the scientific and medical matters contained in the evaluation of the Secretary shall be binding on the Attorney General; and ``(D) except as provided in paragraph (4), not later than 90 days after receiving such evaluation and determination, the Attorney General shall issue an order removing such fentanyl-related substance from the schedules under section 202. ``(2) Determination resulting in rescheduling.--If the Secretary determines, taking into consideration the factors set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedules I and II-- ``(A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; ``(B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; ``(C) consistent with subsection (b), the scientific and medical matters contained in the evaluation of the Secretary shall be binding on the Attorney General; and ``(D) except as provided in paragraph (4), not later than 90 days after receiving such evaluation and determination, the Attorney General shall issue an order removing such fentanyl-related substance from schedule I and controlling such substance under schedule III. ``(3) Evaluation factors.-- ``(A) In general.--In making a determination under paragraph (1) or (2), the Secretary-- ``(i) shall consider the factor listed in paragraph (2) of subsection (c), as established by the assessment described in subparagraph (B) of this paragraph; ``(ii) shall consider the factors listed in paragraphs (1), (3), and (6) of subsection (c); and ``(iii) may consider the factors listed in paragraphs (4), (5), and (7) of subsection (c) if the Secretary finds that evidence exists with respect to those factors. ``(B) Consideration of scientific evidence of pharmacological effect.-- ``(i) In general.--For the purposes of subparagraph (A)(i), consideration by the Secretary of the results of an assessment consisting of the studies described in clause (ii) of this subparagraph shall only suffice to constitute consideration of the factor listed in paragraph (2) of subsection (c) if-- ``(I) each such study is performed according to scientific methods and protocols commonly accepted in the scientific community; and ``(II) the Secretary determines that such assessment is adequate for such purposes. ``(ii) Described studies.--The studies described in this clause include the following: ``(I) One or more receptor binding studies that can-- ``(aa) demonstrate whether the substance has affinity for the human mu opioid receptor and assess the duration and intensity of the binding; and ``(bb) establish displacement by antagonists such as naloxone. ``(II) One or more in vitro functional assays that can demonstrate whether the substance has agonist activity at the human mu opioid receptor. ``(III) One or more in vivo animal behavioral studies that can demonstrate whether the substance has abuse-related drug effects consistent with mu opioid agonist activity, such as demonstrating similarity to the effects of morphine. ``(iii) Guidance.--Not later than 90 days after the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, the Secretary shall publish guidance describing the parameters for studies that meet the criteria established under clause (ii). ``(4) Attorney general review.-- ``(A) In general.--Notwithstanding a determination by the Secretary resulting in removal or rescheduling under paragraph (1) or (2), the Attorney General may not issue an order of removal or rescheduling if, not later than 90 days after receiving the applicable evaluation and determination from the Secretary, the Attorney General finds under the processes described in subsection (h) that maintaining the scheduling of the substance is necessary to avoid an imminent hazard to the public safety. ``(B) Temporary scheduling.--Upon a finding under subparagraph (A), the substance shall be deemed temporarily scheduled for the time period described in subsection (h)(2), which may be extended as provided in that subsection. ``(C) Expiration of temporary scheduling.--Not later than 30 days after the expiration of the time period described in subparagraph (B) and any extension thereof as described in that subparagraph, the Attorney General shall issue an order to remove or reschedule the substance pursuant to the Secretary's determination unless the substance has otherwise been scheduled under the processes described in this section. ``(5) Notice from secretary to attorney general.-- ``(A) Notice of initiation of proceedings.--Not later than 30 days after the date on which the Secretary initiates proceedings to evaluate a substance under paragraph (1) or (2), the Secretary shall notify the Attorney General of the initiation of the proceedings. ``(B) Advance notice regarding evaluation and conclusion.-- Not later than 30 days before the date on which the Secretary sends the Attorney General an evaluation and determination under paragraph (1) or (2), the Secretary shall notify the Attorney General with respect to the evaluation and determination. ``(6) Exception for treaty obligations.--If a fentanyl- related substance is a substance that the United States is obligated to control under international treaties, conventions, or protocols in effect on the date of enactment of the Halt All Lethal Trafficking of Fentanyl Act, this subsection shall not require the Attorney General-- ``(A) to remove such substance from control; or ``(B) to place such substance in a schedule less restrictive than that which the Attorney General determines is necessary to carry out such obligations. ``(7) Identification of fentanyl-related substances.--If the Attorney General determines that a substance is a fentanyl-related substance, the Attorney General shall-- ``(A) not later than 30 days after the date of such determination, notify the Secretary; ``(B) include in such notification the identity of the substance, its structure, and the basis for the determination; and ``(C) as soon as practicable, publish in the Federal Register an updated list under subsection (e)(4) of schedule I that includes the fentanyl-related substance, unless good cause exists not to do so. ``(8) Petitions for transferring a fentanyl-related substance under the drug schedules.-- [[Page S1638]] ``(A) In general.--If a person petitions the Attorney General to remove a fentanyl-related substance from schedule I, to reschedule a fentanyl-related substance to another schedule, or to place a fentanyl-related substance under schedule I, the Attorney General shall consider such a petition in accordance with the procedures and standards set forth in-- ``(i) subsections (a) and (b) of this section; and ``(ii) section 1308.43 of title 21, Code of Federal Regulations (or any successor regulation). ``(B) Attorney general to inform secretary.--Not later than 30 days after the date of accepting a petition described in subparagraph (A), the Attorney General shall forward a copy of the petition to the Secretary. ``(C) Determination procedure not precluded by filing of petition.--The filing of a petition described in this paragraph shall not preclude the Secretary from making a determination and sending an evaluation under paragraph (1) or (2). ``(9) Rules of construction.--Nothing in this subsection shall be construed to preclude the Attorney General from-- ``(A) transferring a substance listed in schedule I to another schedule, or removing such substance entirely from the schedules, pursuant to other provisions of this section and section 202; or ``(B) transferring a fentanyl-related substance from a schedule other than schedule I to schedule I if information supports such a transfer. ``(10) Subsequent controlling of removed substance.--A substance removed from schedule I pursuant to this subsection may, at any time, be controlled pursuant to the other provisions of this section and section 202 without regard to the removal pursuant to this subsection. ``(11) Evaluations or studies.--The Secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances. ``(12) Annual review by secretary.-- ``(A) In general.--Not less frequently than annually, the Secretary shall review fentanyl-related substances identified under paragraph (7), including a review of available evidence and any analysis or data in the possession of the Attorney General with regard to those substances