Domestic Chemical Diversion Control Act of 1993

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Domestic Chemical Diversion Control 
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 chemical'';
            (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 manufacture'';
            (3) in paragraph (34)(A), (F), and (H), by inserting ``, 
        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''; and
                    (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 transaction involving a 
        listed chemical, a tableting machine, or an encapsulating 
        machine'' before the period;
            (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 category 
                of transaction for a specific listed chemical or 
                chemicals'' after ``transaction'';
                    (C) by amending clause (iv) to read as follows:
                    ``(iv) any transaction in a listed chemical that is 
                contained in a drug that may be marketed or distributed 
                lawfully in the United States under the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) unless--
                            ``(I)(aa) the drug contains ephedrine or 
                        its salts, optical isomers, or salts of optical 
                        isomers as the only active medicinal ingredient 
                        or contains ephedrine or its salts, optical 
                        isomers, or salts of optical isomers and 
                        therapeutically insignificant quantities of 
                        another active medicinal ingredient; or
                            ``(bb) the Attorney General has determined 
                        under section 204 that the drug or group of 
                        drugs is being diverted to obtain the listed 
                        chemical for use in the illicit production 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 threshold established for 
                        that chemical by the Attorney 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 precursor 
        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:
    ``(42) 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.
    ``(43) 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, a 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 Attorney General shall 
by regulation remove from exemption under section 102(39)(A)(iv) 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 
controlled 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 formulated 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 Respect 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 distributed in a manner that 
        prevents diversion.
            ``(2) Factors to be considered.--In deciding 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 advertising of 
                the drug product;
                    ``(C) evidence of diversion of the drug product;
                    ``(D) any actions taken by the manufacturer to 
                prevent diversion of the drug product; and
                    ``(E) such other factors as are relevant to and 
                consistent with the public health and safety, including 
                the factors described in subsection (b) as applied to 
                the drug product.
            ``(3) Status pending application for reinstatement.--A 
        transaction involving a particular drug product that is the 
        subject of a bona fide pending 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 subsection (b) to the 
                drug product, the drug product is being diverted; and
                    ``(B) the Attorney General so notifies the 
                applicant.
            ``(4) Amendment and modification.--A regulation 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 subsection 
                (b) to the drug product, the drug product is being 
                diverted; or
                    ``(B) there is a significant change in the data 
                that led to the issuance of the regulation.''.
            (2) Clerical amendment.--The table of contents 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 ``precursor 
        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 registration and control of regulated persons 
and of regulated transactions.''.
    (b) Persons Required To Register Under Section 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 inconsistent with the public 
interest. Registration under this subsection 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 applicable Federal, 
        State, and local law;
            ``(3) any prior conviction record of the applicant under 
        Federal or State laws relating to controlled 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 Registration.--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 appears; 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 Section 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 applicant to import 
or export a list I chemical unless the Attorney 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 export of a drug product that is exempted under section 
102(39)(A)(iv).
    ``(B) In determining the public interest for the purposes 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 amended--
            (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, product, 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 II;
            ``(7) to manufacture, distribute, export, or import 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 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 II or, in the case of an 
        exportation, in violation of this title or title II or of the 
        laws of the country to which it is exported;'';
            (2) by striking the period at the end of paragraph (8) and 
        inserting ``; or''; and
            (3) by adding at the end the following new paragraph:
            ``(9) if the person is a regulated person, to distribute, 
        import, or export a list I chemical without the registration 
        required by this Act.''.

SEC. 4. ANTI-SMUGGLING PROVISION.

    Section 1010(d) of the Controlled Substances Import and Export Act 
(21 U.S.C. 960(d)) is amended--
            (1) by striking ``or'' at the end of paragraph (1); and
            (2) by adding at the end the following new paragraph:
            ``(3) imports or exports a listed chemical in violation of 
        section 1007 or 1018,''.

SEC. 5. 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 regulation of the Attorney General) or regulated persons 
        may lawfully hold, manufacture, distribute, dispense, 
        administer, or otherwise dispose of controlled substances 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 substance''.

SEC. 6. FORFEITURE EXPANSION.

    Section 511(a)(6) of the Controlled Substances Act (21 U.S.C. 
881(a)(6)) is amended by inserting ``or listed chemical'' after 
``controlled substance''.

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 cumulative threshold amount for multiple transactions''.

SEC. 8. 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.

                                 

S 1663 IS----2
S 1663 IS----3

Summary: Domestic Chemical Diversion Control Act of 1993 - Amends the Controlled Substances Act to remove ephedrine products from the legal drug exemption of the Chemical Diversion and Trafficking Act (which currently precludes the application of any of the regulatory control measures of such Act to a listed chemical which is contained in a drug product approved under the Federal Food, Drug, and Cosmetic Act). 
Directs the Attorney General to remove from exemption any other drug products which are being diverted to use in the illicit production of controlled substances. 
Establishes a registration system for distributors, importers, and exporters of listed chemicals which are diverted within the United States.  Directs the Attorney General to register an applicant to distribute, and to import or export, a list I (currently, listed precursor) chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest, based on specified criteria. Amends the Controlled Substances Import and Export Act to set penalties for knowingly or intentionally importing or exporting a listed chemical in violation of such registration requirements. 
Makes provisions of the Controlled Substances Act regarding administrative inspections and authority, forfeiture, and threshold amounts of substances applicable to listed chemicals, as well as to controlled substances.  (Currently only the latter are covered by such provisions.)