I
103D CONGRESS
1ST SESSION
H. R. 1331
To amend the Comprehensive Drug Abuse Prevention and Control Act of
1970 to control the diversion of certain chemicals used in the illicit
production of controlled substances, to provide greater flexibility in the
regulatory controls placed on the legitimate commerce in those chemicals,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 11, 1993
Mr. SCHUMER (for himself and Mr. SENSENBRENNER) introduced the follow-
ing bill; which was referred jointly to the Committees on Energy and
Commerce and the Judiciary
A BILL
To amend the Comprehensive Drug Abuse Prevention and
Control Act of 1970 to control the diversion of certain
chemicals used in the illicit production of controlled sub-
stances, to provide greater flexibility in the regulatory
controls placed on the legitimate commerce in those
chemicals, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Chemical Control
Amendments Act of 1993’’.
SEC. 2. DEFINITION AMENDMENTS.
(a) DEFINITIONS.—Section 102 of the Controlled
Substances Act (21 U.S.C. 802) is amended—
(1) in paragraph (33) by striking ‘‘any listed
precursor chemical or listed essential chemical’’ and
inserting ‘‘any list I chemical or any list II chemi-
cal’’;
(2) in paragraph (34)—
(A) by striking ‘‘listed precursor chemical’’
and inserting ‘‘list I chemical’’; and
(B) by striking ‘‘critical to the creation’’
and inserting ‘‘important to the manufacturer’’;
(3) in paragraph (34) (A), (F), and (H), by in-
serting ‘‘, its esters’’ before ‘‘and’’;
(4) in paragraph (35)—
(A) by striking ‘‘listed essential chemical’’
and inserting ‘‘list II chemical’’;
(B) by inserting ‘‘(other than a list I
chemical)’’ before ‘‘specified’’;
(C) by striking ‘‘as a solvent, reagent, or
catalyst’’; and
(5) in paragraph (38) by inserting ‘‘or who acts
as a broker or trader for an international trans-
action involving a listed chemical, a tableting ma-
chine, or an encapsulating machine’’ before the pe-
riod;
(6) in paragraph (39)(A)—
(A) by striking ‘‘importation or exportation
of’’ and inserting ‘‘importation, or exportation
of, or an international transaction involving
shipment of,’’;
(B) in clause (iii) by inserting ‘‘or any cat-
egory of transaction for a specific listed chemi-
cal or chemicals’’ after ‘‘transaction’’;
(C) by amending clause (iv) to read as fol-
lows:
‘‘(iv) any transaction in a listed chemical
that is contained in a drug that may be mar-
keted or distributed lawfully in the United
States under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) unless—
‘‘(I)(aa) the drug contains ephedrine
or its salts, optical isomers, or salts of op-
tical isomers as the only active medicinal
ingredient or contains ephedrine and thera-
peutically insignificant quantities of an-
other active medicinal ingredient; or
‘‘(bb) the Attorney General has deter-
mined under section 204 that the drug or
group of drugs is being diverted to obtain
the listed chemical for use in the illicit pro-
duction of a controlled substance; and
‘‘(II) the quantity of ephedrine or
other listed chemical contained in the drug
included in the transaction or multiple
transactions equals or exceeds the thresh-
old established for that chemical by the At-
torney General.’’; and
(D) in clause (v) by striking the semicolon
and inserting ‘‘which the Attorney General has
by regulation designated as exempt from the
application of this title and title II based on a
finding that the mixture is formulated in such
a way that it cannot be easily used in the illicit
production of a controlled substance and that
the listed chemical or chemicals contained in
the mixture cannot be readily recovered;’’;
(7) in paragraph (40) by striking ‘‘listed pre-
cursor chemical or a listed essential chemical’’ each
place it appears and inserting ‘‘list I chemical or a
list II chemical’’; and
(8) by adding at the end the following new
paragraphs:
‘‘(43) The term ‘international transaction’ means a
transaction involving the shipment of a listed chemical
across an international border (other than a United States
border) in which a broker or trader located in the United
States participates.
‘‘(44) The terms ‘broker’ and ‘trader’ mean a person
that assists in arranging an international transaction in
a listed chemical by—
‘‘(A) negotiating contracts;
‘‘(B) serving as an agent or intermediary; or
‘‘(C) bringing together a buyer and seller,
buyer, and transporter, or a seller and transporter.’’.
(b) REMOVAL OF EXEMPTION OF CERTAIN DRUGS.—
(1) PROCEDURE.—Part B of the Controlled
Substances Act (21 U.S.C. 811 et seq.) is amended
by adding at the end the following new section:
‘‘REMOVAL OF EXEMPTION OF CERTAIN DRUGS
‘‘SEC. 204. (a) REMOVAL OF EXEMPTION.—The At-
torney General shall by regulation remove from exemption
under section 102(39)(A)(iv)(II) a drug or group of drugs
that the Attorney General finds is being diverted to obtain
a listed chemical for use in the illicit production of a con-
trolled substance.
‘‘(b) FACTORS TO BE CONSIDERED.—In removing a
drug or group of drugs from exemption under subsection
(a), the Attorney General shall consider, with respect to
a drug or group of drugs that is proposed to be removed
from exemption—
‘‘(1) the scope, duration, and significance of the
diversion;
‘‘(2) whether the drug or group of drugs is for-
mulated in such a way that it cannot be easily used
in the illicit production of a controlled substance;
and
‘‘(3) whether the listed chemical can be readily
recovered from the drug or group of drugs.
‘‘(c) SPECIFICITY OF DESIGNATION.—The Attorney
General shall limit the designation of a drug or a group
of drugs removed from exemption under subsection (a) to
the most particularly identifiable type of drug or group
of drugs for which evidence of diversion exists unless there
is evidence, based on the pattern of diversion and other
relevant factors, that the diversion will not be limited to
that particular drug or group of drugs.
‘‘(d) REINSTATEMENT
OF EXEMPTION WITH RE-
SPECT TO PARTICULAR DRUG PRODUCTS.—
‘‘(1) REINSTATEMENT.—On application by a
manufacturer of a particular drug product that has
been removed from exemption under subsection (a),
the Attorney General shall by regulation reinstate
the exemption with respect to that particular drug
product if the Attorney General determines that the
particular drug product is manufactured and distrib-
uted in a manner that prevents diversion.
‘‘(2) FACTORS TO BE CONSIDERED.—In decid-
ing whether to reinstate the exemption with respect
to a particular drug product under paragraph (1),
the Attorney General shall consider—
‘‘(A) the package sizes and manner of
packaging of the drug product;
‘‘(B) the manner of distribution and adver-
tising of the drug product;
‘‘(C) evidence of diversion of the drug
product;
‘‘(D) any actions taken by the manufac-
turer to prevent diversion of the drug product;
and
‘‘(E) such other factors as are relevant to
and consistent with the public health and safe-
ty, including the factors described in subsection
(b) as applied to the drug product.
‘‘(3) STATUS PENDING APPLICATION FOR REIN-
STATEMENT.—A transaction involving a particular
drug product that is the subject of a bona fide pend-
ing application for reinstatement of exemption filed
with the Attorney General not later than 60 days
after a regulation removing the exemption is issued
pursuant to subsection (a) shall not be considered to
be a regulated transaction if the transaction occurs
during the pendency of the application and, if the
Attorney General denies the application, during the
period of 60 days following the date on which the
Attorney General denies the application, unless—
‘‘(A) the Attorney General has evidence
that, applying the factors described in sub-
section (b) to the drug product, the drug prod-
uct is being diverted; and
‘‘(B) the Attorney General so notifies the
applicant.
‘‘(4) AMENDMENT AND MODIFICATION.—A reg-
ulation reinstating an exemption under paragraph
(1) may be modified or revoked with respect to a
particular drug product upon a finding that—
‘‘(A) applying the factors described in sub-
section (b) to the drug product, the drug prod-
uct is being diverted; or
‘‘(B) there is a significant change in the
data that led to the issuance of the regula-
tion.’’.
(2) TECHNICAL
AMENDMENT.—The table of
contents of the Comprehensive Drug Abuse Preven-
tion and Control Act of 1970 (84 Stat. 1236) is
amended by adding at the end of the section relating
to part B of title II the following new item:
‘‘Sec. 204. Removal of exemption of certain drugs.’’.
(c) REGULATION OF LISTED CHEMICALS.—Section
310 of the Controlled Substances Act (21 U.S.C. 830) is
amended—
(1) in subsection (a)(1)—
(A) by striking ‘‘precursor chemical’’ and
inserting ‘‘list I chemical’’; and
(B) in subparagraph (B) by striking ‘‘an
essential chemical’’ and inserting ‘‘a list II
chemical’’; and
(2) in subsection (c)(2)(D) by striking ‘‘precur-
sor chemical’’ and inserting ‘‘chemical control’’.
SEC. 3. REGISTRATION REQUIREMENTS.
(a) RULES AND REGULATIONS.—Section 301 of the
Controlled Substances Act (21 U.S.C. 821) is amended
by striking the period and inserting ‘‘and to the registra-
tion and control of regulated persons and of regulated
transactions.’’.
(b) PERSONS REQUIRED TO REGISTER UNDER SEC-
TION 302.—Section 302 of the Controlled Substances Act
(21 U.S.C. 822) is amended—
(1) in subsection (a)(1) by inserting ‘‘or list I
chemical’’ after ‘‘controlled substance’’ each place it
appears;
(2) in subsection (b)—
(A) by inserting ‘‘or list I chemicals’’ after
‘‘controlled substances’’; and
(B) by inserting ‘‘or chemicals’’ after
‘‘such substances’’;
(3) in subsection (c) by inserting ‘‘or list I
chemical’’ after ‘‘controlled substance’’ each place it
appears; and
(4) in subsection (e) by inserting ‘‘or list I
chemicals’’ after ‘‘controlled substances’’.
(c) REGISTRATION REQUIREMENTS UNDER SECTION
303.—Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended by adding at the end the following
new subsection:
‘‘(h) The Attorney General shall register an applicant
to distribute a list I chemical unless the Attorney General
determines that registration of the applicant is inconsist-
ent with the public interest. Registration under this sub-
section shall not be required for the distribution of a drug
product that is exempted under section 102(39)(A)(iv). In
determining the public interest for the purposes of this
subsection, the Attorney General shall consider—
‘‘(1) maintenance by the applicant of effective
controls against diversion of listed chemicals into
other than legitimate channels;
‘‘(2) compliance by the applicant with applica-
ble Federal, State and local law;
‘‘(3) any prior conviction record of the appli-
cant under Federal or State laws relating to con-
trolled substances or to chemicals controlled under
Federal or State law;
‘‘(4) any past experience of the applicant in the
manufacture and distribution of chemicals; and
‘‘(5) such other factors as are relevant to and
consistent with the public health and safety.’’.
(d) DENIAL, REVOCATION, OR SUSPENSION OF REG-
ISTRATION.—Section 304 of the Controlled Substances
Act (21 U.S.C. 824) is amended—
(1) in subsection (a)—
(A) by inserting ‘‘or a list I chemical’’
after ‘‘controlled substance’’ each place it ap-
pears; and
(B) by inserting ‘‘or list I chemicals’’ after
‘‘controlled substances’’;
(2) in subsection (b) by inserting ‘‘or list I
chemical’’ after ‘‘controlled substance’’;
(3) in subsection (f) by inserting ‘‘or list I
chemicals’’ after ‘‘controlled substances’’ each place
it appears; and
(4) in subsection (g)—
(A) by inserting ‘‘or list I chemicals’’ after
‘‘controlled substances’’ each place it appears;
and
(B) by inserting ‘‘or list I chemical’’ after
‘‘controlled substance’’ each place it appears.
(e) PERSONS REQUIRED TO REGISTER UNDER SEC-
TION 1007.—Section 1007 of the Controlled Substances
Import and Export Act (21 U.S.C. 957) is amended—
(1) in subsection (a)—
(A) in paragraph (1) by inserting ‘‘or list
I chemical’’ after ‘‘controlled substance’’; and
(B) in paragraph (2) by striking ‘‘in sched-
ule I, II, III, IV, or V,’’ and inserting ‘‘or list
I chemical,’’; and
(2) in subsection (b)—
(A) in paragraph (1) by inserting ‘‘or list
I chemical’’ after ‘‘controlled substance’’ each
place it appears; and
(B) in paragraph (2) by inserting ‘‘or list
I chemicals’’ after ‘‘controlled substances’’.
(f) REGISTRATION REQUIREMENTS UNDER SECTION
1008.—Section 1008 of the Controlled Substances Import
and Export Act (21 U.S.C. 958) is amended—
(1) in subsection (c)—
(A) by inserting ‘‘(1)’’ after ‘‘(c)’’; and
(B) by adding at the end the following new
paragraph:
‘‘(2)(A) The Attorney General shall register an appli-
cant to import or export a list I chemical unless the Attor-
ney General determines that registration of the applicant
is inconsistent with the public interest. Registration under
this subsection shall not be required for the import or ex-
port of a drug product that is exempted under section
102(39)(A)(iv).
‘‘(B) In determining the public interest for the pur-
poses of subparagraph (A), the Attorney General shall
consider the factors specified in section 303(h).’’;
(2) in subsection (d)—
(A) in paragraph (3) by inserting ‘‘or list
I chemical or chemicals,’’ after ‘‘substances,’’;
and
(B) in paragraph (6) by inserting ‘‘or list
I chemicals’’ after ‘‘controlled substances’’ each
place it appears;
(3) in subsection (e) by striking ‘‘and 307’’ and
inserting ‘‘307, and 310’’; and
(4) in subsections (f), (g), and (h) by inserting
‘‘or list I chemicals’’ after ‘‘controlled substances’’
each place it appears.
(g) PROHIBITED ACTS C.—Section 403(a) of the
Controlled Substances Act (21 U.S.C. 843(a)) is amend-
ed—
(1) by striking ‘‘or’’ at the end of paragraph
(7);
(2) by striking the period at the end of para-
graph (8) and inserting ‘‘; or’’; and
(3) by adding at the end the following new
paragraph:
‘‘(9) if the person is a regulated person, to dis-
tribute, import, or export a list I chemical without
the registration required by this Act.’’.
SEC. 4. REPORTING OF LISTED CHEMICAL MANUFACTUR-
ING.
Section 310(b) of the Controlled Substances Act (21
U.S.C. 830(b)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘(b)’’;
(2) by redesignating paragraphs (1), (2), (3),
and (4) as subparagraphs (A), (B), (C), and (D), re-
spectively;
(3) by striking ‘‘paragraph (1)’’ each place it
appears and inserting ‘‘subparagraph (A)’’;
(4) by striking ‘‘paragraph (2)’’ and inserting
‘‘subparagraph (B)’’;