[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 830 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 830
To amend the Controlled Substances Act with respect to fentanyl-related
substances, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 31, 2025
Mr. Pappas (for himself, Ms. Salazar, and Mr. Newhouse) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Save Americans from the Fentanyl
Emergency Act'' or the ``SAFE Act''.
SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUBSTANCES.
Section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c))
is amended by adding at the end of schedule I the following:
``(e)(1) Unless specifically exempted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of fentanyl-related substances, or which contains
their salts, isomers, and salts of isomers whenever the existence of
such salts, isomers, and salts of isomers is possible within the
specific chemical designation.
``(2) In this subsection, except as provided in paragraph (3), the
term `fentanyl-related substance' means any substance that is
structurally related to fentanyl by one or more of the following
modifications:
``(A) By replacement of the phenyl portion of the phenethyl
group by any monocycle, whether or not further substituted in
or on the monocycle.
``(B) By substitution in or on the phenethyl group with
alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or
nitro groups.
``(C) By substitution in or on the piperidine ring with
alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo,
haloalkyl, amino, or nitro groups.
``(D) By replacement of the aniline ring with any aromatic
monocycle whether or not further substituted in or on the
aromatic monocycle.
``(E) By replacement of the N-propionyl group with another
acyl group.
``(3) A substance that meets the criteria specified in paragraph
(2) to be considered a fentanyl-related substance shall not be so
considered as meeting such criteria if such substance--
``(A) is controlled by action of the Attorney General
pursuant to section 201;
``(B) is expressly listed in this schedule or another
schedule by a statutory provision other than this subsection;
or
``(C) is removed from this schedule, or rescheduled to
another schedule, pursuant to section 201(k).
``(4) The Attorney General shall publish in the Federal Register a
list of individual substances that meet the definition of fentanyl-
related substances in paragraph (2) within 60 days of determining such
substances meet such definition. The absence of a substance on any such
list does not negate the control status of such substance if the
substance meets the criteria specified in paragraph (2) to be
considered a fentanyl-related substance.
``(5) Notwithstanding any other provision of this title or title
III, fentanyl-related substances shall not be subject to quantity-based
mandatory minimum penalties pursuant to subparagraph (A)(vi) or (B)(vi)
of section 401(b)(1) of this title or paragraph (1)(F) or (2)(F) of
section 1010(b) of title III.''.
SEC. 3. PENALTY PROVISIONS WITH RESPECT TO FENTANYL-RELATED
SUBSTANCES--DOMESTIC OFFENSES.
Section 401(b)(1) of the Controlled Substances Act (21 U.S.C.
841(b)(1)) is amended--
(1) in subparagraph (A), by striking clause (vi) and
inserting the following:
``(vi)(I) 400 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(II) 100 grams or more of a mixture or substance
containing a detectable amount of any analogue of fentanyl that
is controlled in schedule I or II or that is treated as a
schedule I controlled substance pursuant to section 203(a),
except for a fentanyl-related substance as defined in schedule
I(e) of section 202(c);'';
(2) in subparagraph (B), by striking clause (vi) and
inserting the following:
``(vi)(I) 40 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(II) 10 grams or more of a mixture or substance
containing a detectable amount of any analogue of fentanyl that
is controlled in schedule I or II or that is treated as a
schedule I controlled substance pursuant to section 203(a),
except for a fentanyl-related substance as defined in schedule
I(e) of section 202(c);''; and
(3) in subparagraph (C), by inserting ``, including a
fentanyl-related substance as defined in schedule I(e) of
section 202(c),'' after ``a controlled substance in schedule I
or II,''.
SEC. 4. PENALTY PROVISIONS WITH RESPECT TO FENTANYL-RELATED
SUBSTANCES--IMPORT AND EXPORT OFFENSES.
Section 1010(b) of the Controlled Substances Import and Export Act
(21 U.S.C. 960(b)) is amended--
(1) in paragraph (1), by striking subparagraph (F) and
inserting the following:
``(F)(i) 400 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(ii) 100 grams or more of a mixture or substance
containing a detectable amount of any analogue of fentanyl that
is controlled in schedule I or II or that is treated as a
schedule I controlled substance pursuant to section 203(a) of
the Controlled Substances Act, except for a fentanyl-related
substance as defined in schedule I(e) of section 202(c) of the
Controlled Substances Act;'';
(2) in paragraph (2), by striking subparagraph (F) and
inserting the following:
``(F)(i) 40 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(ii) 10 grams or more of a mixture or substance
containing a detectable amount of any analogue of fentanyl that
is controlled in schedule I or II or that is treated as a
schedule I controlled substance pursuant to section 203(a) of
the Controlled Substances Act, except for a fentanyl-related
substance as defined in schedule I(e) of section 202(c) of the
Controlled Substances Act;''; and
(3) in paragraph (3), by inserting ``including a fentanyl-
related substance as defined in schedule I(e) of section 202(c)
of the Controlled Substances Act,'' after ``a controlled
substance in schedule I or II,''.
SEC. 5. 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 new subsection:
``(k) Removal From Schedule I of Fentanyl-Related Substances.--
``(1) Determination resulting in removal.--If the Secretary
determines, taking into consideration factors as 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 determination of
the Secretary contained in such evaluation shall be
binding on the Attorney General; and
``(D) 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 factors as 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) the scientific and medical determination of
the Secretary contained in such evaluation shall be
binding on the Attorney General; and
``(D) not later than 90 days after receiving such
evaluation, 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--
``(I) the factor listed in
paragraph (2) of subsection (c);
``(II) the factors listed in
paragraphs (1), (3), and (6) of such
subsection to the extent evidence
exists with respect to such factors;
and
``(III) any information submitted
to the Secretary by the Attorney
General for purposes of such
determination; and
``(ii) may consider the factors listed in
paragraphs (4), (5), and (7) of subsection (c)
if the Secretary finds that evidence exists
with respect to such factors.
``(B) Consideration of scientific evidence of
pharmacological effect.--
``(i) In general.--For the purposes of
subparagraph (A)(i)(I), consideration by the
Secretary of the results of an assessment
consisting of the studies described in clause
(ii) shall 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 are any of the
following:
``(I) A receptor binding study that
can demonstrate whether the substance
has affinity for the human mu opioid
receptor.
``(II) An in vitro functional assay
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.
``(4) Advance notice regarding evaluation and conclusion.--
The Secretary shall give the Attorney General at least 30 days
notice before sending the Attorney General an evaluation and
determination under paragraph (1) or (2) with respect to a
fentanyl-related substance.
``(5) 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 Save
Americans from the Fentanyl Emergency 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.
``(6) Identification of fentanyl-related substances.--If
the Attorney General or any official of the Department of
Justice determines that a substance is a fentanyl-related
substance, the Attorney General shall--
``(A) within 30 days of such determination, notify
the Secretary; and
``(B) include in such notification the identity of
the substance, its structure, and the basis for the
determination.
``(7) Petitions for removing a fentanyl-related
substance.--
``(A) In general.--If a person petitions the
Attorney General to remove a fentanyl-related substance
from schedule I(e) or to reschedule such a substance to
another schedule, 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
regulations).
``(B) Attorney general to inform secretary.--Within
30 days of receiving such a petition, 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 under
this paragraph shall not preclude the Secretary from
making a determination and sending an evaluation under
paragraph (1) or (2).
``(8) Rule of construction.--Nothing in this subsection
shall be construed to preclude the Attorney General from
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.
``(9) 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.
``(10) Evaluations or studies.--The Secretary may enter
into contracts or other agreements to conduct or support
evaluations or studies of fentanyl-related substances.
``(11) Definition.--In this subsection, the term `fentanyl-
related substance' means a fentanyl-related substance as
defined in schedule I(e) of section 202(c).''.
SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHEDULED SUBSTANCES.
(a) Domestic Cases.--Section 401(b) of the Controlled Substances
Act (21 U.S.C. 841(b)) is amended by adding at the end the following:
``(8) Past Convictions Involving Fentanyl-Related Substance.--
``(A) In general.--In the case of a defendant whose offense
of conviction under this title involved a fentanyl-related
substance (as defined in schedule I(e) of section 202(c) as of
the date the offense was committed) that has since been removed
from designation as a fentanyl-related substance for purposes
of this title and has been placed on any schedule other than
schedule I or II or has been removed from the controlled
substance schedules, the sentencing court may, on motion of the
defendant, the Bureau of Prisons, the attorney for the
Government, or on its own motion, after considering the factors
set forth in section 3553(a) of title 18, United States Code,
vacate the previously imposed sentence, or impose a reduced
sentence on any count of conviction as if the removal or
placement was in effect at the time that the offense was
committed. Nothing in this section may be construed to require
a court to vacate or reduce any sentence.
``(B) Defendant not required to be present.--
Notwithstanding rule 43 of the Federal Rules of Criminal
Procedure, the defendant is not required to be present at any
hearing on whether to vacate or reduce a sentence pursuant to
this section.''.
(b) Import and Export Cases.--Section 1010(b) of the Controlled
Substances Import and Export Act (21 U.S.C. 960(b)) is amended by
adding at the end the following:
``(8) In the case of a defendant whose offense of conviction under
this title involved a fentanyl-related substance (as defined in
schedule I(e) of section 202(c) of the Controlled Substances Act as of
the date the offense was committed) that has since been removed from
designation as a fentanyl-related substance for purposes of this title
and has been placed on any schedule other than schedule I or II or has
been removed from the controlled substance schedules, the sentencing
court may, on motion of the defendant, the Bureau of Prisons, the
a