HHS 21 CFR PART 1313-2011 IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS《表I和表II中化学品的进出口》.pdf

1、194 21 CFR Ch. II (4111 Edition) 1312.45 (c) If any applicant entitled to a hearing pursuant to 1312.42 fails to ap-pear at the hearing, he shall be deemed to have waived his opportunity for the hearing unless he shows good cause for such failure. (d) If the applicant waives or is deemed to have wai

2、ved this oppor-tunity for the hearing, the Adminis-trator may cancel the hearing, if scheduled, and issue his final order pur-suant to 1312.47 without a hearing. 37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 1312.45 Burden of proof. At any hearing on the denial of an applica

3、tion for an import, export, or transshipment permit, the Adminis-trator shall have the burden of proving that the requirements for such permit pursuant to sections 1002, 1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are not satisfied. 37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609,

4、 Sept. 24, 1973 1312.46 Time and place of hearing. (a) If any applicant for an import, ex-port, or transshipment permit requests a hearing on the issuance or denial of his application, the Administrator shall hold such hearing. Notice of the hearing shall be given to the applicant of the time and pl

5、ace at least 30 days prior to the hearing, unless the appli-cant waives such notice and requests the hearing be held at an earlier time, in which case the Administrator shall fix a date for such hearing as early as reasonably possible. (b) The hearing will commence at the place and time designated i

6、n the notice given pursuant to paragraph (a) of this section but thereafter it may be moved to a different place and may be contin-ued from day to day or recessed to a later day without notice other than an-nouncement thereof by the presiding officer at the hearing. 37 FR 15924, Aug. 8, 1972. Redesi

7、gnated at 38 FR 26609, Sept. 24, 1973 1312.47 Final order. As soon as practicable after the pre-siding officer has certified the record to the Administrator, the Adminis-trator shall issue his order on the issuance or denial of the application for and import, export, or trans-shipment permit. The or

8、der shall in-clude the findings of fact and conclu-sions of law upon which the order is based. The Administrator shall serve one copy of his order upon the appli-cant. 37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 PART 1313IMPORTATION AND EXPORTATION OF LIST I AND LIST II CH

9、EMICALS Sec. 1313.01 Scope. 1313.02 Definitions. 1313.05 Requirements for an established business relationship. 1313.08 Requirements for establishing a record as an importer. IMPORTATION OF LISTED CHEMICALS 1313.12 Requirement of authorization to im-port. 1313.13 Contents of import declaration. 1313

10、.14 Distribution of import declaration. 1313.15 Waiver of 15-day advance notice for regular importers. 1313.16 Transfers following importation. 1313.17 Return declaration or amendment to Form 486 for imports. EXPORTATION OF LISTED CHEMICALS 1313.21 Requirement of authorization to ex-port. 1313.22 Co

11、ntents 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. 1313.26 Transfers following exportation. 1313.27 Return declaration or amendment to Form 486 for exports. TRANSSHIPMENTS, IN-

12、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 trans-action declaration. 1313.34 Distribution of

13、 the international transaction declaration. 1313.35 Return declaration or amendment to Form 486 for international transactions. 1313.41 Suspension of shipments. 1313.42 Prohibition of shipments from cer-tain foreign sources. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00204 Fmt 8010 S

14、fmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-195 Drug Enforcement Administration, Justice 1313.12 HEARINGS 1313.51 Hearings generally. 1313.52 Purpose of hearing. 1313.53 Waiver of mo

15、dification of rules. 1313.54 Request for hearing. 1313.55 Burden of proof. 1313.56 Time and place of hearing. 1313.57 Final order. AUTHORITY: 21 U.S.C. 802, 830, 871(b), 971. SOURCE: 54 FR 31665, Aug. 1, 1989, unless otherwise noted. 1313.01 Scope. Procedures governing the importa-tion, exportation,

16、 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 1313.02 Definitions. Any term used

17、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 1313.05 Requirements for an estab-lished business relationship. To document that an importer or ex-porter has an established business rela-tionship with

18、 a customer, the importer or exporter must provide the Adminis-trator with the following information in accordance with the waiver of 15-day advance notice requirements of 1313.15 or 1313.24: (a) The name and street address of the chemical importer or exporter and of each regular customer; (b) The t

19、elephone number, contact person, and where available, the fac-simile number for the chemical im-porter or exporter and for each regular customer; (c) The nature of the regular cus-tomers business (i.e., importer, ex-porter, distributor, manufacturer, etc.), and if known, the use to which the listed

20、chemical or chemicals will be applied; (d) The duration of the business rela-tionship; (e) The frequency and number of transactions occurring during the pre-ceding 12-month period; (f) The amounts and the listed chem-ical or chemicals involved in regulated transactions between the chemical im-porter

21、 or exporter and regular cus-tomer; (g) The method of delivery (direct shipment or through a broker or for-warding agent); and (h) Other information that the chem-ical importer or exporter considers rel-evant for determining whether a cus-tomer is a regular customer. 72 FR 17407, Apr. 9, 2007 1313.0

22、8 Requirements for estab-lishing a record as an importer. To establish a record as an importer, the regulated person must provide the Administrator with the following infor-mation in accordance with the waiver of the 15-day advance notice require-ments of 1313.15: (a) The name, DEA registration num-

23、ber (where applicable), street address, telephone number, and, where avail-able, the facsimile number of the regu-lated person and of each foreign sup-plier; and (b) The frequency and number of transactions occurring during the pre-ceding 12 month period. 72 FR 17407, Apr. 9, 2007 IMPORTATION OF LIS

24、TED CHEMICALS 1313.12 Requirement of authoriza-tion to import. (a) Each regulated person who im-ports a listed chemical that meets or exceeds the threshold quantities identi-fied in 1310.04(f) or is a listed chemical for which no threshold has been estab-lished as identified in 1310.04(g) of this ch

25、apter, 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 by the Import/Export Unit, Drug Enforcement Administration, not later than 15 days prior to the importa-tion. See the Table of DEA Ma

26、iling Ad-dresses in 1321.01 of this chapter for the current mailing address. A copy of the completed DEA Form 486 may be VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00205 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduc

27、tion or networking permitted without license from IHS-,-,-196 21 CFR Ch. II (4111 Edition) 1313.13 transmitted directly to the Drug En-forcement Administration through electronic facsimile media not later than 15 days prior to the importation. (c) The 15-day advance notification requirement for list

28、ed chemical im-ports may be waived for the following: (1) Any importation that meets both of the following requirements: (i) The regulated person has satisfied the requirements for reporting to the Administration as a regular importer of the listed chemicals. (ii) The importer intends to transfer th

29、e listed chemicals to a person who is a regular customer for the chemical, as defined in 1300.02 of this chapter. (2) A specific listed chemical, as set forth in paragraph (f) of this section, for which the Administrator deter-mines that advance notification is not necessary for effective chemical d

30、iver-sion control. (d) For imports where advance notifi-cation is waived pursuant to paragraph (c)(1) of this section, the DEA Form 486 must be received by the Drug Enforce-ment Administration, Chemical Oper-ations Section, on or before the date of importation through use of the mailing address list

31、ed 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 reg-ulated person shall submit quarterly reports to the Import/Export Unit, Drug Enforcement

32、 Administration, no later than the 15th day of the month following the end of each quarter. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing address. The report shall con-tain the following information regard-ing each individual importation: (1) The name of t

33、he listed chemical; (2) The quantity and date imported; (3) The name and full business ad-dress 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 fol-lowing li

34、sted chemicals: (1) Acetone. (2) 2-Butanone (or Methyl Ethyl Ke-tone 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; 72 FR 17407, Apr. 9, 2007; 75 FR 10683, Mar. 9, 2010 131

35、3.13 Contents of import declara-tion. (a) Any List I or List II chemical list-ed 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

36、 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 quan-tity of a listed chemical shall notify the Administration through procedures set forth in 1313.12 and distribute three co

37、pies of DEA Form 486 as di-rected in 1313.14. (c) The DEA Form 486 must be exe-cuted 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, tel

38、ex, 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 n

39、umber 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 for-eign port of exportation and the first U.S. Customs Port of Entry; and (4) The name, ad

40、dress, telephone number, telex number, and, where available, the facsimile number of the consigner in the foreign country of ex-portation; and VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot

41、 for ResaleNo reproduction or networking permitted without license from IHS-,-,-197 Drug Enforcement Administration, Justice 1313.16 (5) The name, address, telephone number, and where available, the fac-simile number of the person or persons to whom the importer intends to trans-fer the listed chemi

42、cal and the quan-tity to be transferred to each trans-feree. (d) Any regulated person importing ephedrine, pseudoephedrine, or phenyl-propanolamine must submit, on the import declaration, all information known to the importer on the chain of distribution of the chemical from the manufacturer to the

43、importer. Ephed-rine, pseudoephedrine, or phenyl-propanolamine include each of the salts, optical isomers, and salts of opti-cal isomers of the chemical. 54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 72 FR 17407, Apr. 9, 2007; 75 FR 10171, Mar. 5, 2010 1313.14 Distribution of

44、import dec-laration. The required three copies of the list-ed chemical import declaration (DEA Form 486) will be distributed as fol-lows: (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 retain

45、ed for four years; declaration forms for List II chemical must be re-tained 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 s

46、hall be presented to the U.S. Customs Sevice along with the customs entry. If the import is a regu-lated transaction for which the 15-day advance notice requirement has been waived, the regulated person shall de-clare this information to the U.S. Cus-toms Service Official by checking the block on th

47、e DEA Form 486 designated for this purpose. 54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995 1313.15 Waiver of 15-day advance no-tice for regular importers. (a) Each regulated person seeking designation as a regular importer shall provide, by certified mail return receipt requeste

48、d, to the Administra-tion such information as is required under 1313.08 documenting their sta-tus as a regular importer. (b) Each regulated person making ap-plication under paragraph (a) of this section shall be considered a regular importer for purposes of waiving the 15-day advance notice, 30 days

49、 after re-ceipt of the application by the Admin-istration, as indicated on the return re-ceipt, unless the regulated person is otherwise notified in writing by the Administration. (c) The Administrator, may, at any time, disqualify a regulated persons status as a regular importer on the grounds that the chemical being im-ported may be diverted to the clandes-tine manufacture of a controlled sub-stance. (d) Unless the Ad