Date="03/24/94" Citation="59 FR 13881" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Provisional Exemption From Registration for Certain List I Chemical Ha ndlers"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Provisional Exemption From Registration for Certain List I Chemical Handlers AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Provisional Exemption From Registration for Certain List I Chemical Handlers AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim rule. + ------------------------------------------------------------ SUMMARY: Under the provisions of the Domestic Chemical Diversion Control Act of 1993 (DCDCA), which was enacted on December 17, 1993, and becomes effective April 16, 1994, any person who manufactures, distributes, imports or exports a list I chemical (formerly known as a precursor chemical), or who proposes to do so, must first obtain a registration. Since regulations implementing the DCDCA may not be finalized by April 16, 1994, DEA is establishing a temporary exemption from the registration requirement for any person who must register under the DCDCA. The exemption will stay in effect for each affected person until DEA has either approved the person's application for registration or the Administrator has issued a final order regarding the application, provided that the person makes proper application for registration within 45 days of the effective date of the regulations implementing the DCDCA. Failure to submit to a proper application within this time period will invalidate the exemption. At this time, affected persons are requested to submit to DEA a notice of their intent to seek registration. EFFECTIVE DATE: March 24, 1994. FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-4025. SUPPLEMENTARY INFORMATION: On December 17, 1993, the Domestic Chemical Diversion Control Act of 1993 was enacted. The DCDCA redesignates precursor chemicals and essential chemicals in Title 21, section 802, as list I chemicals and list II chemicals respectively, and requires that any person who manufactures, distributes, imports or exports a list I chemical shall obtain an annual registration from DEA for each location where such activities are carried out. The DCDCA also removes the exemption from the definition of a regulated transaction for drugs marketed or distributed under the Food, Drug and Cosmetic Act which either, (1) contain ephedrine or its salts, optical isomers, or salts of optical isomers either as the only active medicinal ingredient or in combination with therapeutically insignificant quantities of another active medicinal ingredient, or (2) contain another listed chemical which DEA has determined is being diverted to obtain the listed chemical for use in the manufacture of a controlled substance. As a result, any person who manufactures, imports, exports or distributes, either by wholesale or retail sales, any drug described above will be required to register and will also be subject to the applicable requirements of the DCDCA and title 21, Code of Federal Regulations, parts 1310 and 1313, when the DCDCA becomes effective on April 16, 1994. Those persons manufacturing, distributing, importing, or exporting drugs distributed or marketed under the Food, Drug and Cosmetic Act which contain ephedrine in combination with therapeutically significant quantities of another drug will remain exempt from the requirements of the DCDCA and the applicable portions of title 21 of the regulations. The DCDCA also establishes certain other requirements with respect to listed chemicals which will be addressed in a separate Federal Register notice proposing the establishment of regulations implementing the DCDCA. In the event that the regulations and administrative mechanisms to implement the DCDCA are not finalized prior to the April 16, 1994 effective date, DEA is establishing a temporary exemption from the registration requirement for affected persons who manufacture, distribute, import or export list I chemicals. Each affected person will be exempted from the registration requirement until they have made proper application for registration with DEA, provided such application is made within 45 days after the effective date of the regulations implementing the DCDCA, and that application has either been approved by DEA or the Administrator has issued a final order regarding the application following a full administrative proceeding pursuant to sections 823 and 824 of the Controlled Substances Act. Failure to make proper application within the specified time period will result in loss of the exemption. Further, the exemption will apply only to the requirement to register which goes into effect in April 16, 1994. All other requirements of the DCDCA become effective on April 16, 1994, and the requirements of parts 1310 and 1313 of title 21 of the regulations will remain in full force and effect. The change in the designation of the regulated chemicals from precursor and essential to list I and list II chemicals will have no effect on the requirements of parts 1310 and 1313. To assist DEA in ensuring that the necessary information regarding registration and application forms reaches the affected persons, these persons are requested to notify DEA at this time of their intent to register for their activities. The notice should reflect the name under which business is conducted, the address at which the list I chemical activities are conducted, the type of activity (i.e., manufacture, distribute, import or export), and the specific list I chemical(s) involved. Notice should be submitted for each separate physical location at which such activities are carried out. Notices should be sent to: Drug Enforcement Administration, Chemical Operations Section, Office of Diversion Control, Washington, DC 20537. With respect to persons who manufacture list I chemicals, DEA has made a preliminary determination that registration will not be required for persons who manufacture a list I chemical solely for internal consumption with no subsequent distribution or exportation of the List I chemical. Those persons who manufacture a list I chemical for distribution will be required to register. Specific details regarding DEA's determination will be set forth in the Federal Register notice proposing the regulations to implement the DCDCA. The Acting Administrator of the Drug Enforcement Administration hereby certifies that this interim rulemaking will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This interim rulemaking grants a temporary exemption from the registration requirements of the DCDCA pending completion of the regulatory amendments necessary to implement the DCDCA. This rule is not a significant regulatory action and therefore has not been reviewed by the Office of Management and Budget pursuant to Executive Order 12866. This action has been analyzed in accordance with the principles and criteria in Executive Order 12612, and it has been determined that the interim rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1310 Drug traffic control, Reporting and recordkeeping requirements, List I and List II chemicals. For reasons set out above, title 21, Code of Federal Regulations, part 1310 is amended as follows. PART 1310-[AMENDED] 1. The authority citation for part 1310 continues to read as follows: Authority: 21 U.S.C. 802, 830, 871(b). 2. Section 1310.09 is added to read as follows: sec 1310.09 Temporary exemption from registration. Each person required by section 3(b) of the Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103-200, effective April 16, 1994), to obtain a registration to manufacture, distribute, import, or export a list I chemical (other than those list I chemicals exempted under sec 1310.01(f)(1)(iv)), is temporarily exempted from the registration requirement. The exemption will remain in effect for each person until the person has made proper application for registration and the Administration has approved or denied such application, provided that the application has been submitted within 45 days following the effective date of the regulations in part 1309 implementing the Domestic Chemical Diversion Control Act of 1993. This exemption applies only to registration; all other chemical control requirements set forth in the Domestic Chemical Diversion Control Act of 1993 and in parts 1310 and 1313 of this chapter remain in full force and effect. Dated: March 17, 1994. Stephen H. Greene, Acting Administrator, Drug Enforcement Administration. [FR Doc. 94-6884 Filed 3-23-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Domestic Chemical Diversion Control Act of 1993; implementation: List I chemical handlers; provisional exemption from registration, 13881