21 C.F.R. PART 1313—IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
Title 21 - Food and Drugs
Authority: 21 U.S.C. 802, 830, 871(b), 971.
Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
Procedures governing the importation, exportation, transshipment and in-transit shipment of listed chemicals pursuant to section 1018 of the Act (21 U.S.C. 971) are governed generally by that section and specifically by the sections of this part. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995] Any term used in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. [62 FR 13969, Mar. 24, 1997] (a) Each regulated person who imports a listed chemical that meets or exceeds the threshold quantities identified in §1310.04(f) or is a listed chemical for which no threshold has been established as identified in §1310.04(g) of this chapter, shall notify the Administrator of the importation not later than 15 days before the transaction is to take place. (b) A completed DEA Form 486 must be received at the following address not later than 15 days prior to the importation: Drug Enforcement Administration, P.O. Box 27284, Washington, DC 20038. A copy of the completed DEA Form 486 may be transmitted directly to the Drug Enforcement Administration, Chemical Control Section, through electronic facsimile media not later than 15 days prior to the importation. (c) The 15-day advance notification requirement for listed chemical imports may be waived for: (1) Any regulated person who has satisfied the requirements for reporting to the Administration as a regular importer of such listed chemicals; or (2) A specific listed chemical, as set forth in paragraph (f) of this section, for which the Administrator determines that advance notification is not necessary for effective chemical diversion control. (d) For imports where advance notification is waived pursuant to paragraph (c)(1) of this section, the DEA Form 486 must be received by the Drug Enforcement Administration, Chemical Operations Section, on or before the date of importation through use of the mailing address listed in §1313.12(b) or through use of electronic facsimile media. (e) For importations where advance notification is waived pursuant to paragraph (c)(2) of this section no DEA Form 486 is required, however, the regulated person shall submit quarterly reports to the Drug Enforcement Administration, Chemical Operations Section, P.O. Box 27284, Washington, DC 20038, by no later than the 15th day of the month following the end of each quarter. The report shall contain the following information regarding each individual importation: (1) The name of the listed chemical; (2) The quantity and date imported; (3) The name and full business address of the supplier; (4) The foreign port of embarkation; and (5) The port of entry. (f) The 15 day advance notification requirement set forth in paragraph (a) has been waived for imports of the following listed chemicals: (1) Acetone. (2) 2-Butanone (or Methyl Ethyl Ketone or MEK). (3) Toluene. [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, July 31, 2002] (a) Any List I or List II chemical listed in §1310.02 of this chapter may be imported if that chemical is necessary for medical, commercial, scientific, or other legitimate uses within the United States. Chemical importations into the United States for immediate transfer/transshipment outside the United States must comply with the procedures set forth in §1313.31. (b) Any regulated person who desires to import a threshold or greater quantity of a listed chemical shall notify the Administration through procedures set forth in §1313.12 and distribute three copies of DEA Form 486 as directed in §1313.14. (c) The DEA Form 486 must be executed in triplicate and must include the following information: (1) The name, address, telephone number, telex number, and, where available, the facsimile number of the chemical importer; the name, address, telephone, telex, and where available, the facsimile number of the broker or forwarding agent (if any); and (2) The name and description of each listed chemical as it appears on the label or container, the name of each chemical as it is designated in 1310.02 of this chapter, the size or weight of container, the number of containers, the net weight of each listed chemical given in kilograms or parts thereof; and the gross weight of the shipment given in kilograms or parts thereof; and (3) The proposed import date, the foreign port of exportation and the first U.S. Customs Port of Entry; and (4) The name, address, telephone number, telex number, and, where available, the facsimile number of the consignor in the foreign country of exportation. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995] The required three copies of the listed chemical import declaration (DEA Form 486) will be distributed as follows: (a) Copy 1 shall be retained on file by the regulated person as the official record of import. Import declaration forms involving a List I chemical must be retained for four years; declaration forms for List II chemical must be retained for two years. (b) Copy 2 is the Drug Enforcement Administration copy used to fulfill the notification requirements of Section 6053 of the Chemical Diversion and Trafficking Act of 1988, as specified in §1313.12. (c) Copy 3 shall be presented to the U.S. Customs Sevice along with the customs entry. If the import is a regulated transaction for which the 15-day advance notice requirement has been waived, the regulated person shall declare this information to the U.S. Customs Service Official by checking the block on the DEA Form 486 designated for this purpose. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995] (a) Each regulated person seeking designation as a “regular importer” shall provide, by certified mail return receipt requested, to the Administration such information as is required under §1300.02(b)(13), documenting their status as a regular importer. (b) Each regulated person making application under paragraph (a) of this section shall be considered a “regular importer” for purposes of waiving the 15-day advance notice, 30 days after receipt of the application by the Administration, as indicated on the return receipt, unless the regulated person is otherwise notified in writing by the Administration. (c) The Administrator, may, at any time, disqualify a regulated person's status as a regular importer on the grounds that the chemical being imported may be diverted to the clandestine manufacture of a controlled substance. (d) Unless the Administration notifies the chemical importer to the contrary, the qualification of a regular importer of any one of these three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that importer as a regular importer of all three of these chemicals. (e) All chemical importers shall be required to file a DEA Form 486 as required by Section 1313.12. [60 FR 32464, June 22, 1995, as amended at 62 FR 13969, Mar. 24, 1997] (a) No person shall export or cause to be exported from the United States any chemical listed in §1310.02 of this chapter, which meets or exceeds the threshold quantities identified in §1310.04(f) or is a listed chemical for which no threshold has been established as identified in §1310.04(g) of this chapter, until such time as the Administrator has been notified. Notification must be made not later than 15 days before the transaction is to take place. In order to facilitate the export of listed chemicals and implement the purpose of the Act, regulated persons may wish to provide notification to the Administration as far in advance of the 15 days as possible. (b) A completed DEA Form 486 must be received at the following address not later than 15 days prior to the exportation: Drug Enforcement Administration, P.O. Box 27284, Washington, DC 20038. A copy of the completed DEA Form 486 may be transmitted directly to the Drug Enforcement Administration, Chemical Control Section, through electronic facsimile media not later than 15 days prior to the exportation. (c) The 15-day advance notification requirement for listed chemical exports may be waived for: (1) Any regulated person who has satisfied the requirements of Section 1313.24 for reporting to the Administration an established business relationship with a foreign customer as defined in §1300.02(b)(12). (2) A specific listed chemical to a specified country, as set forth in paragraph (f) of this section, for which the Administrator determines that advance notification is not necessary for effective chemical diversion control. (d) For exports where advance notification is waived pursuant to paragraph (c)(1) of this section, the DEA Form 486 must be received by the Drug Enforcement Administration, Chemical Operations Section, on or before the date of exportation through use of the mailing address listed in Section 1313.12(b) or through use of electronic facsimile media. (e) For exportations where advance notification is waived pursuant to paragraph (c)(2) of this section, no DEA Form 486 is required, however, the regulated person shall file quarterly reports to the Drug Enforcement Administration, Chemical Control Section, P.O. Box 27284, Washington, DC 20038, by no later than the 15th day of the month following the end of each quarter. The report shall contain the following information regarding each individual exportation: (1) The name of the listed chemical; (2) The quantity and date exported; (3) The name and full business address of the foreign customer; (4) The port of embarkation; and (5) The foreign port of entry. (f) The 15 day advance notification requirement set forth in paragraph (a) of this section has been waived for exports of the following listed chemicals to the following countries: (g) No person shall export or cause to be exported any listed chemical, knowing or having reasonable cause to believe the export is in violation of the laws of the country to which the chemical is exported or the chemical will be used to manufacture a controlled substance in violation of the Act or the laws of the country to which the chemical is exported. The Administration will publish a notice of foreign import restrictions for listed chemicals of which DEA has knowledge as provided in §1313.25. [54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 FR 32464, June 22, 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, July 31, 2002] (a) Any List I or List II chemical listed in §1310.02 of this chapter which meets or exceeds the quantitative threshold criteria established in §1310.04(f) of this chapter may be exported if that chemical is needed for medical, commercial, scientific, or other legitimate uses. (b) Any regulated person who desires to export a threshold or greater quantity of a listed chemical shall notify the Administration through procedures outlined in §1313.21 and distribute three copies of DEA Form 486 as directed in §1313.23. (c) The DEA Form 486 must be executed in triplicate and must include all the following information: (1) The name, address, telephone number, telex number, and, where available, the facsimile number of the chemical exporter; the name, address, telephone number, telex number, and, where available, the facsimile number of the export broker, if any; (2) The name and description of each listed chemical as it appears on the label or container, the name of each listed chemical as it is designated in §1310.02 of this chapter, the size or weight of container, the number of containers, the net weight of each listed chemical given in kilograms or parts thereof, and the gross weight of the shipment given in kilograms or parts thereof; (3) The proposed export date, the U.S. Customs port of exportation, and the foreign port of entry; and (4) The name, address, telephone, telex, and where available, the facsimile number of the consignee in the country where the chemical shipment is destined; the name(s) and address(es) of any intermediate consignee(s). (d) Notwithstanding the time limitations included in paragraph (b) of this section, a regulated person may receive a waiver of the 15-day advance notification requirement following the procedures outlined in §1313.24. (e) Declared exports of listed chemicals which are refused, rejected, or otherwise deemed undeliverable may be returned to the U.S. chemical exporter of record. A brief written notification (this does not require a DEA Form 486) outlining the circumstances must be sent to the Drug Enforcement Administration, P.O. Box 27284, Washington, DC 20038, following the return within a reasonable time. This provision does not apply to shipments that have cleared foreign customs, been delivered, and accepted by the foreign consignee. Returns to third parties in the United States will be regarded as imports. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 67 FR 49569, July 31, 2002] The required three copies of the listed chemical export declaration (DEA Form 486) will be distributed as follows: (a) Copy 1 shall be retained on file by the chemical exporters as the official record of export. Export declaration forms involving a List I chemical must be retained for four years; declaration forms for list II chemical must be retained for two years. (b) Copy 2 is the Drug Enforcement Administration copy used to fulfill the notification requirements of Section 6053 of the Chemical Diversion and Trafficking Act of 1988, as specified in §1313.21 (c) Copy 3 shall be presented to the U.S. Customs Service at the port of exit for each export of a listed chemical or chemicals on or before the day of exportation, and when possible, along with the Shippers Export Declaration. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 61 FR 51004, Sept. 30, 1996] (a) Each regulated person shall provide to the Administration the identity and information listed in §1300.02(b)(12) for an established business relationship with a foreign customer not later than August 31, 1989. (b) Not later than October 31, 1989, each regular customer so identified in notifications made under §1313.24(a) shall be a regular customer for purposes of waiving the 15-day advance notice requirement, unless the regulated person is otherwise notified in writing by the Administration. (c) Each foreign customer identified on an initial DEA Form 486 submitted after the effective date of the implementation of part 1313 shall, after the expiration of the 15-day period, qualify as a regular customer, unless the Administration otherwise notifies the regulated person in writing. (d) Unless the Administration notifies the chemical exporter to the contrary, the qualification of a regular customer for any one of these three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that customer as a regular customer for all three of these chemicals. (e) The Administrator may notify any chemical exporter that a regular customer has been disqualified or that a new customer for whom a notification has been submitted is not to be accorded the status of a regular customer. In the event of a disqualification of an established regular customer, the chemical exporter will be notified in writing of the reasons for such action. Public reporting (one-time) burden for this collection of information is estimated to average four hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing and collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to the Drug Enforcement Administration, Records Management Section, Washington, DC 20537; and to the Office of Management and Budget, Paperwork Reduction Project No. 1117–0025, Washington, DC 20503. [54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 FR 13969, Mar. 24, 1997] Any export from the United States in violation of the law of the country to which the chemical is exported is subject to the penalties of Title 21 United States Code 960(d). (a) A quantity of a chemical listed in §1310.02 of this chapter that meets or exceeds the threshold reporting requirements found in §1310.04(f) of this chapter may be imported into the United States for transshipment, or may be transferred or transshipped within the United States for immediate exportation, provided that advance notice is given to the Administration. (b) Advance notification must be provided to the Drug Enforcement Administration, P.O. Box 27284, Washington, DC 20038, not later than 15 days prior to the proposed date the listed chemical will transship or transfer through the United States. The written notification (not a DEA Form 486) shall contain the following information: (1) The date the notice was executed; (2) The complete name and description of the listed chemical as it appears on the label or container. (3) The name of the listed chemical as designated by §1310.02 of this chapter. (4) The number of containers and the size or weight of the container for each listed item; (5) The new weight of each listed chemical given in kilograms or parts thereof; (6) The gross weight of the shipment given in kilograms or parts thereof; (7) The name, address, telephone number, telex number, business of the foreign exporter and, where available, the facsimile number; (8) The foreign port of exportation; (9) The approximate date of exportation; (10) The complete identification of the exporting carrier; (11) The name, address, business, telephone number, telex number, and, where available, the facsimile number of the importer, transferor, or transshipper; (12) The U.S. port of entry; (13) The approximate date of entry; (14) The name, address, telephone number, telex number, business of the consignee and, where available, facsimile number of the consignee at the foreign port of entry; (15) The shipping route from the U.S. port of exportation to the foreign port of entry at final destination; (16) The approximate date of receipt by the consignee at the foreign port of entry; and (17) The signature of the importer, transferor or transshipper, or his agent, accompanied by the agent's title. (c) Unless notified to the contrary prior to the expected date of delivery, the importation for transshipment or transfer is considered approved. (d) No waiver of the 15-day advance notice will be given for imports of listed chemicals in quantities meeting or exceeding threshold quantities for transshipment or transfer outside the United States. [54 FR 31665, Aug. 1, 1989, as amended at 67 FR 49569, July 31, 2002] (a) A broker or trader shall notify the Administrator prior to an international transaction involving a listed chemical which meets or exceeds the threshold amount identified in Section 1310.04 of this chapter, in which the broker or trader participates. Notification must be made no later than 15 days before the transaction is to take place. In order to facilitate an international transaction involving listed chemicals and implement the purpose of the Act, regulated persons may wish to provide advance notification to the Administration as far in advance of the 15 days as possible. (b)(1) A completed DEA Form 486 must be received at the following address not later than 15 days prior to the international transaction:
Drug Enforcement Administration, P.O. Box 27284, Washington, D.C. 20038 (2) A copy of the DEA Form 486 may be transmitted directly to the Drug Enforcement Administration, Chemical Operations Section, through electronic facsimile media not later than 15 days prior to the exportation. (c) No person shall serve as a broker or trader for an international transaction involving a listed chemical knowing or having reasonable cause to believe that the transaction is in violation of the laws of the country to which the chemical is exported or the chemical will be used to manufacture a controlled substance in violation of the laws of the country to which the chemical is exported. The Administration will publish a notice of foreign import restrictions for listed chemicals of which DEA has knowledge as provided in Section 1313.25. [60 FR 32465, June 22, 1995; 61 FR 17566, Apr. 22, 1996; 67 FR 49569, July 31, 2002] (a) An international transaction involving a chemical listed in §1310.02 of this chapter which meets the threshold criteria established in §1310.04 of this chapter may be arranged by a broker or trader if the chemical is needed for medical, commercial, scientific, or other legitimate uses. (b) Any broker or trader who desires to arrange an international transaction involving a listed chemical which meets the criteria set forth in Section 1310.04 shall notify the Administration through the procedures outlined in Section 1313.32(b). (c) The DEA Form 486 must be executed in triplicate and must include all the following information: (1) The name, address, telephone number, telex number, and, where available, the facsimile number of the chemical exporter; the name, address, telephone number, telex number, and, where available, the facsimile number of the chemical importer; (2) The name and description of each listed chemical as it appears on the label or container, the name of each listed chemical as it is designated in Section 1310.02 of this chapter, the size or weight of container, the number of containers, the net weight of each listed chemical given in kilograms or parts thereof, and the gross weight of the shipment given in kilograms or parts thereof; (3) The proposed export date, the port of exportation, and the port of importation; and (4) The name, address, telephone, telex, and where available, the facsimile number, of the consignee in the country where the chemical shipment is destined; the name(s) and address(es) of any intermediate consignee(s). [60 FR 32465, June 22, 1995] The required three copies of the DEA Form 486 will be distributed as follows: (a) Copies 1 and 3 shall be retained on file by the broker or trader as the official record of the international transaction. Declaration forms involving List I chemicals shall be retained for List II chemicals shall be retained for four years; declaration forms for two years. (b) Copy 2 is the Drug Enforcement Administration copy used to fulfill the notification requirements of Section 1313.32. [60 FR 32465, June 22, 1995; 60 FR 35264, July 6, 1995] (a) The Administrator may suspend any importation or exportation of a chemical listed in §1310.02 of this chapter based on evidence that the chemical proposed to be imported or exported may be diverted to the clandestine manufacture of a controlled substance. If the Administrator so suspends, he shall provide written notice of such suspension to the regulated person. Such notice shall contain a statement of the legal and factual basis for the order. (b) Upon service of the order of suspension, the regulated person to whom the order applies under paragraph (a) of this section must, if he desires a hearing, file a written request for a hearing pursuant to §§1313.51–1313.57. In any case where a regulated person requests a hearing regarding the suspension of a shipment of a listed chemical, the procedures for such hearing shall be governed generally by the procedures set forth in the Administrative Procedure Act (5 U.S.C. 551–559) and specifically by section 6053 of the Chemical Diversion and Trafficking Act (Pub. L. 100–690), by 21 CFR 1313.52–1313.57, and by the procedures for administrative hearings under the Controlled Substances Act set forth in §§1316.41–1316.67 of this chapter. If requested by a person entitled to a hearing, the Administrator shall cause a hearing to be held for the purpose of receiving factual evidence regarding the issues involved in the suspension of shipments within 45 days of the date of the request, unless the requesting party requests an extension of time. The Administrator or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this part by notice in advance of the hearing, if he determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing. (a) Any person entitled to a hearing pursuant to §1313.52 and desiring a hearing shall, within 30 days after receipt of the notice to suspend the shipment, file with the Administrator a written request for a hearing in the form prescribed in §1316.47 of this chapter. (b) If any person entitled to a hearing or to participate in a hearing pursuant to §1313.41 fails to file a request for a hearing or a notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing or to participate in the hearing, unless he shows good cause for such failure. (c) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to §1313.57. At any hearing regarding the suspension of shipments, the Agency shall have the burden of proving that the requirements of this part for such suspension are satisfied. (a) If any regulated person requests a hearing on the suspension of shipments, a hearing will be scheduled no later than 45 days after the request is made, unless the regulated person requests an extension to this date. (b) The hearing will commence at the place and time designated in the notice given pursuant to paragraph (a) of this section but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing. As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall issue his order regarding the suspension of shipment. The order shall include the findings of fact and conclusions of law upon which the order is based. The Administrator shall serve one copy of his order upon each party in the hearing.
Title 21: Food and Drugs
PART 1313—IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
Section Contents
§ 1313.01 Scope.
§ 1313.02 Definitions.
Importation of Listed Chemicals
§ 1313.12 Requirement of authorization to import.
§ 1313.13 Contents of import declaration.
§ 1313.14 Distribution of import declaration.
§ 1313.15 Waiver of 15-day advance notice for regular importers.
Exportation of Listed Chemicals
§ 1313.21 Requirement of authorization to export.
§ 1313.22 Contents of export declaration.
§ 1313.23 Distribution of export declaration.
§ 1313.24 Waiver of 15-day advance notice for chemical exporters.
§ 1313.25 Foreign import restrictions.
Transshipments, In-Transit Shipments and International Transactions Involving Listed Chemicals
§ 1313.31 Advance notice of importation for transshipment or transfer.
§ 1313.32 Requirement of authorization for international transactions.
§ 1313.33 Contents of an international transaction declaration.
§ 1313.34 Distribution of the international transaction declaration.
§ 1313.41 Suspension of shipments.
Hearings
§ 1313.51 Hearings generally.
§ 1313.52 Purpose of hearing.
§ 1313.53 Waiver of modification of rules.
§ 1313.54 Request for hearing.
§ 1313.55 Burden of proof.
§ 1313.56 Time and place of hearing.
§ 1313.57 Final order.
§ 1313.01 Scope.
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§ 1313.02 Definitions.
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Importation of Listed Chemicals
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§ 1313.12 Requirement of authorization to import.
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§ 1313.13 Contents of import declaration.
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§ 1313.14 Distribution of import declaration.
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§ 1313.15 Waiver of 15-day advance notice for regular importers.
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Exportation of Listed Chemicals
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§ 1313.21 Requirement of authorization to export.
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------------------------------------------------------------------------ Name of Chemical Country------------------------------------------------------------------------[Reserved]................................ ............................------------------------------------------------------------------------
§ 1313.22 Contents of export declaration.
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§ 1313.23 Distribution of export declaration.
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§ 1313.24 Waiver of 15-day advance notice for chemical exporters.
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§ 1313.25 Foreign import restrictions.
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Transshipments, In-Transit Shipments and International Transactions Involving Listed Chemicals
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§ 1313.31 Advance notice of importation for transshipment or transfer.
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§ 1313.32 Requirement of authorization for international transactions.
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§ 1313.33 Contents of an international transaction declaration.
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§ 1313.34 Distribution of the international transaction declaration.
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§ 1313.41 Suspension of shipments.
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Hearings
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§ 1313.51 Hearings generally.
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§ 1313.52 Purpose of hearing.
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§ 1313.53 Waiver of modification of rules.
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§ 1313.54 Request for hearing.
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§ 1313.55 Burden of proof.
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§ 1313.56 Time and place of hearing.
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§ 1313.57 Final order.
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