‘‘(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) CLERICAL AMENDMENT.—The table of con-
tents of the Comprehensive Drug Abuse Prevention
and Control Act of 1970 (84 Stat. 1236) is amended
by adding at the end of that portion 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
schedule 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 amending paragraphs (6) and (7) to
read as follows:
‘‘(6) to possess any three-neck round-bottom
flask, tableting machine, encapsulating machine, or
gelatin capsule, or any equipment, chemical, prod-
uct, or material which may be used to manufacture
a controlled substance or listed chemical, knowing,
intending, or having reasonable cause to believe, that
it will be used to manufacture a controlled substance
or listed chemical in violation of this title or title III;
‘‘(7) to manufacture, distribute, export, or im-
port any three-neck round-bottom flask, tableting
machine, encapsulating machine, or gelatin capsule,
or any equipment, chemical, product, or material
which may be used to manufacture a controlled sub-
stance or listed chemical, knowing, intending, or
having reasonable cause to believe, that it will be
used to manufacture a controlled substance or listed
chemical in violation of this title or title III or, in
the case of an exportation, in violation of this title
or title III or of the laws of the country to which
it is exported;’’;
(b) PROHIBITED ACTS A.—Section 1010(d) of the
Controlled Substances Import and Export Act (21 U.S.C.
960(d)) is amended to read as follows:
‘‘(d) A person who knowingly or intentionally—
‘‘(1) imports or exports a listed chemical with
intent to manufacture a controlled substance in vio-
lation of this title or title II;
‘‘(2) exports a listed chemical in violation of the
laws of the country to which the chemical is ex-
ported or serves as a broker or trader for an inter-
national transaction involving a listed chemical, if
the transaction is in violation of the laws of the
country to which the chemical is exported;
‘‘(3) imports or exports a listed chemical know-
ing, or having reasonable cause to believe, that the
chemical will be used to manufacture a controlled
substance in violation of this title or title II; or
‘‘(4) exports a listed chemical, or serves as a
broker or trader for an international transaction in-
volving a listed chemical, knowing, or having reason-
able cause to believe, that the chemical will be used
to manufacture a controlled substance in violation of
the laws of the country to which the chemical is ex-
ported,
shall be fined in accordance with title 18, imprisoned not
more than 10 years, or both.’’.
SEC. 5. EXEMPTION AUTHORITY; ANTISMUGGLING PROVI-
SION.
(a) NOTIFICATION REQUIREMENT.—Section 1018 of
the Controlled Substances Import and Export Act (21
U.S.C. 971), as amended by section 1505(a) of this Act,
is amended by adding at the end the following new sub-
section:
‘‘(e)(1) The Attorney General may by regulation re-
quire that the 15-day notification requirement of sub-
section (a) apply to all exports of a listed chemical to a
specified country, regardless of the status of certain cus-
tomers in such country as regular customers, if the Attor-
ney General finds that such notification is necessary to
support effective chemical diversion control programs or
is required by treaty or other international agreement to
which the United States is a party.
‘‘(2) The Attorney General may by regulation waive
the 15-day notification requirement for exports of a listed
chemical to a specified country if the Attorney General
determines that such notification is not required for effec-
tive chemical diversion control. If the notification require-
ment is waived, exporters of the listed chemical shall be
required to submit to the Attorney General reports of indi-
vidual exportations or periodic reports of such exportation
of the listed chemical, at such time or times and contain-
ing such information as the Attorney General shall estab-
lish by regulation.
‘‘(3) The Attorney General may by regulation waive
the 15-day notification requirement for the importation of
a listed chemical if the Attorney General determines that
such notification is not necessary for effective chemical di-
version control. If the notification requirement is waived,
importers of the listed chemical shall be required to submit
to the Attorney General reports of individual importations
or periodic reports of the importation of the listed chemi-
cal, at such time or times and containing such information
as the Attorney General shall establish by regulation.’’.
(b) PROHIBITED ACTS A.—Section 1010(d) of the
Controlled Substances Import and Export Act (21 U.S.C.
960(d)), as amended by section 4(b) of this Act, is amend-
ed—
(1) by striking ‘‘or’’ at the end of paragraph
(3);
(2) by striking the comma at the end of para-
graph (4) and inserting a semicolon; and
(3) by adding at the end the following new
paragraphs:
‘‘(5) imports or exports a listed chemical, with
the intent to evade the reporting or recordkeeping
requirements of section 1018 applicable to such im-
portation or exportation by falsely representing to
the Attorney General that the importation or expor-
tation qualifies for a waiver of the 15-day notifica-
tion requirement granted pursuant to section
1018(e) (2) or (3) by misrepresenting the actual
country of final destination of the listed chemical or
the actual listed chemical being imported or ex-
ported; or
‘‘(6) imports or exports a listed chemical in vio-
lation of section 1007 or 1018,’’.
SEC. 6. ADMINISTRATIVE INSPECTIONS AND AUTHORITY.
Section 510 of the Controlled Substances Act (21
U.S.C. 880) is amended—
(1) by amending subsection (a)(2) to read as
follows:
‘‘(2) places, including factories, warehouses,
and other establishments, and conveyances, where
persons registered under section 303 (or exempt
from registration under section 302(d) or by regula-
tion of the Attorney General) or regulated persons
may lawfully hold, manufacture, distribute, dispense,
administer, or otherwise dispose of controlled sub-
stances or listed chemicals or where records relating
to those activities are maintained.’’; and
(2) in subsection (b)(3)—
(A) in subparagraph (B), by inserting ‘‘,
listed chemicals,’’ after ‘‘unfinished drugs’’; and
(B) in subparagraph (C), by inserting ‘‘or
listed chemical’’ after ‘‘controlled substance’’
and inserting ‘‘or chemical’’ after ‘‘such sub-
stance’’.
SEC. 7. THRESHOLD AMOUNTS.
Section 102(39)(A) of the Controlled Substances Act
(21 U.S.C. 802(39)(A)), as amended by section 2, is
amended by inserting ‘‘a listed chemical, or if the Attorney
General establishes a threshold amount for a specific listed
chemical,’’ before ‘‘a threshold amount, including a cumu-
lative threshold amount for multiple transactions’’.
SEC. 8. AMENDMENTS TO LIST I.
Section 102(34) of the Controlled Substances Act (21
U.S.C. 802(34)) is amended—
(1) by striking subparagraphs (O), (U), and
(W);
(2) by redesignating subparagraphs (P) through
(T) as (O) through (S), subparagraph (V) as (T),
and subparagraphs (X) and (Y) as (U) and (X), re-
spectively;
(3) in subparagraph (X), as redesignated by
paragraph (2), by striking ‘‘(X)’’ and inserting
‘‘(U)’’; and
(4) by inserting after subparagraph (U), as re-
designated by paragraph (2), the following new sub-
paragraphs:
‘‘(V) benzaldehyde.
‘‘(W) nitroethane.’’.
SEC. 9. ELIMINATION OF REGULAR SUPPLIER STATUS AND
CREATION OF REGULAR IMPORTER STATUS.
(a) DEFINITION.—Section 102(37) of the Controlled
Substances Act (21 U.S.C. 802(37)) is amended to read
as follows:
‘‘(37) The term ‘regular importer’ means, with re-
spect to a listed chemical, a person that has an established
record as an importer of that listed chemical that is re-
ported to the Attorney General.’’.
(b) NOTIFICATION.—Section 1018 of the Controlled
Substances Act (21 U.S.C. 971) is amended—
(1) in subsection (b)—
(A) in paragraph (1) by striking ‘‘regular
supplier of the regulated person’’ and inserting
‘‘to an importation by a regular importer’’; and
(B) in paragraph (2)—
(i) by striking ‘‘a customer or supplier
of a regulated person’’ and inserting ‘‘a
customer of a regulated person or to an
importer’’; and
(ii) by striking ‘‘regular supplier’’ and
inserting ‘‘the importer as a regular im-
porter’’; and
(2) in subsection (c)(1) by striking ‘‘regular
supplier’’ and inserting ‘‘regular importer’’.
SEC. 10. 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)’’;
(5) by striking ‘‘paragraph (3)’’ and inserting
‘‘subparagraph (C)’’; and
(6) by adding at the end the following new
paragraph:
‘‘(2) A regulated person that manufactures a
listed chemical shall report annually to the Attorney
General, in such form and manner and containing
such specific data as the Attorney General shall pre-
scribe by regulation, information concerning listed
chemicals manufactured by the person. The require-
ment of the preceding sentence shall not apply to the
manufacture of a drug product that is exempted
under section 102(39)(A)(iv).’’.
SEC. 11. EFFECTIVE DATE.
This Act and the amendments made by this Act shall
take effect on the date that is 120 days after the date
of enactment of this Act.
Passed the House of Representatives November 21,
1993.
Attest:
DONNALD K. ANDERSON,
Clerk.
HR 3216 RDS——2