21 U.S.C. § 971 — Notification, suspension of shipment, and

Page 908 TITLE 21—FOOD AND DRUGS § 969 Editorial Notes CODIFICATION Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter. Section was formerly classified to section 1035 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, § 1, Sept. 13, 1982, 96 Stat. 877. Section was also formerly classified to section 198b of this title. § 969. Contempt proceedings In case of contumacy by, or refusal to obey a subpena issued to, any person, the Secretary of the Treasury may invoke the aid of any court of the United States within the jurisdiction of which the investigation is carried on or of which the subpenaed person is an inhabitant, carries on business or may be found, to compel compli- ance with the subpena of the Secretary of the Treasury. The court may issue an order requir- ing the subpenaed person to appear before the Secretary of the Treasury there to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey the order of the court may be punished by the court as a contempt thereof. All process in any such case may be served in the ju- dicial district whereof the subpenaed person is an inhabitant or wherever he may be found. (Aug. 11, 1955, ch. 800, § 3, 69 Stat. 685.) Editorial Notes CODIFICATION Section was not enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 which comprises this chapter. Section was formerly classified to section 1036 of Title 31 prior to the general revision and enactment of Title 31, Money and Finance, by Pub. L. 97–258, § 1, Sept. 13, 1982, 96 Stat. 877. Section was also formerly classified to section 198c of this title. § 970. Criminal forfeitures Section 853 of this title, relating to criminal forfeitures, shall apply in every respect to a vio- lation of this subchapter punishable by impris- onment for more than one year. (Pub. L. 91–513, title III, § 1017, as added Pub. L. 98–473, title II, § 307, Oct. 12, 1984, 98 Stat. 2051.) § 971. Notification, suspension of shipment, and penalties with respect to importation and ex- portation of listed chemicals (a) Notification prior to transaction Each regulated person who imports or exports a listed chemical shall notify the Attorney Gen- eral of the importation or exportation not later than 15 days before the transaction is to take place. (b) Regular customers or importers (1) The Attorney General shall provide by reg- ulation for circumstances in which the require- ment of subsection (a) does not apply to a trans- action between a regulated person and a regular customer or to a transaction that is an importa- tion by a regular importer. At the time of any importation or exportation constituting a trans- action referred to in the preceding sentence, the regulated person shall notify the Attorney Gen- eral of the transaction. (2) The regulations under this subsection shall provide that the initial notification under sub- section (a) with respect to a customer of a regu- lated person or to an importer shall, upon the expiration of the 15-day period, qualify the cus- tomer as a regular customer or the importer as a regular importer, unless the Attorney General otherwise notifies the regulated person in writ- ing. (c) Suspension of importation or exportation; disqualification of regular customers or im- porters; hearing (1) The Attorney General may order the sus- pension of any importation or exportation of a listed chemical (other than a regulated trans- action to which the requirement of subsection (a) does not apply by reason of subsection (b)) or may disqualify any regular customer or regular importer on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, in- cluding the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred). From and after the time when the Attorney General provides written notice of the order (including a statement of the legal and factual basis for the order) to the regulated per- son, the regulated person may not carry out the transaction. (2) Upon written request to the Attorney Gen- eral, a regulated person to whom an order ap- plies under paragraph (1) is entitled to an agen- cy hearing on the record in accordance with sub- chapter II of chapter 5 of title 5. The hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time, if so requested by the regulated person. (d) Information required in notice; updated no- tice for change in circumstances (1)(A) Information provided in a notice under subsection (a) or (b) shall include the name of the person to whom the importer or exporter in- volved intends to transfer the listed chemical involved, and the quantity of such chemical to be transferred. (B) In the case of a notice under subsection (b) submitted by a regular importer, if the trans- feree identified in the notice is not a regular customer, such importer may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the notice is submitted to the Attorney General. (C) After a notice under subsection (a) or (b) is submitted to the Attorney General, if cir- cumstances change and the importer or exporter will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the importer or ex- porter shall update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after Page 909 TITLE 21—FOOD AND DRUGS § 971 the expiration of the 15-day period beginning on the date on which the update is submitted to the Attorney General, except that such 15-day re- striction does not apply if the prospective trans- feree identified in the update is a regular cus- tomer. The preceding sentence applies with re- spect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as such sentence applies with respect to changing cir- cumstances regarding a transferee or quantity identified in the original notice under sub- section (a) or (b). (D) In the case of a transfer of a listed chem- ical that is subject to a 15-day restriction under subparagraph (B) or (C), the transferee involved shall, upon the expiration of the 15-day period, be considered to qualify as a regular customer, unless the Attorney General otherwise notifies the importer or exporter involved in writing. (2) With respect to a transfer of a listed chem- ical with which a notice or update referred to in paragraph (1) is concerned: (A) The Attorney General, in accordance with the same procedures as apply under sub- section (c)(2)— (i) may order the suspension of the trans- fer of the listed chemical by the importer or exporter involved, except for a transfer to a regular customer, on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (with- out regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred), sub- ject to the Attorney General ordering such suspension before the expiration of the 15- day period referred to in paragraph (1) with respect to the importation or exportation (in any case in which such a period applies); and (ii) may, for purposes of clause (i) and paragraph (1), disqualify a regular customer on such ground. (B) From and after the time when the Attor- ney General provides written notice of the order under subparagraph (A) (including a statement of the legal and factual basis for the order) to the importer or exporter, the im- porter or exporter may not carry out the transfer. (3) For purposes of this subsection: (A) The terms ‘‘importer’’ and ‘‘exporter’’ mean a regulated person who imports or ex- ports a listed chemical, respectively. (B) The term ‘‘transfer’’, with respect to a listed chemical, includes the sale of the chem- ical. (C) The term ‘‘transferee’’ means a person to whom an importer or exporter transfers a list- ed chemical. (e) Broker or trader for international trans- action in listed chemical A person located in the United States who is a broker or trader for an international trans- action in a listed chemical that is a regulated transaction solely because of that person’s in- volvement as a broker or trader shall, with re- spect to that transaction, be subject to all of the notification, reporting, recordkeeping, and other requirements placed upon exporters of listed chemicals by this subchapter and subchapter I. (f) Application of notification requirement to ex- ports of listed chemical; waiver (1) The Attorney General may by regulation require that the 15-day notification requirement of subsection (a) apply to all exports of a listed chemical to a specified country, regardless of the status of certain customers in such country as regular customers, if the Attorney General finds that such notification is necessary to sup- port effective chemical diversion control pro- grams or is required by treaty or other inter- national 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 coun- try if the Attorney General determines that such notification is not required for effective chemical diversion control. If the notification requirement is waived, exporters of the listed chemical shall be required to submit to the At- torney General reports of individual expor- tations or periodic reports of such exportation of the listed chemical, at such time or times and containing such information as the Attorney General shall establish by regulation. (3) The Attorney General may by regulation waive the 15-day notification requirement for the importation of a listed chemical if the At- torney General determines that such notifica- tion 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 chem- ical, at such time or times and containing such information as the Attorney General shall es- tablish by regulation. (g) Return declaration Within 30 days after a transaction covered by this section is completed, the importer or ex- porter shall send the Attorney General a return declaration containing particulars of the trans- action, including the date, quantity, chemical, container, name of transferees, and such other information as the Attorney General may speci- fy in regulations. For importers, a single return declaration may include the particulars of both the importation and distribution. If the im- porter has not distributed all chemicals im- ported by the end of the initial 30-day period, the importer shall file supplemental return dec- larations no later than 30 days from the date of any further distribution, until the distribution or other disposition of all chemicals imported pursuant to the import notification or any up- date are accounted for. (h) Importation and distribution of ephedrine, pseudoephedrine, or phenylpropanolamine (1) With respect to a regulated person import- ing ephedrine, pseudoephedrine, or phenyl- propanolamine (referred to in this section as an ‘‘importer’’), a notice of importation under sub- section (a) or (b) shall include all information known to the importer on the chain of distribu- Page 910 TITLE 21—FOOD AND DRUGS § 971 tion of such chemical from the manufacturer to the importer. (2) For the purpose of preventing or respond- ing to the diversion of ephedrine, pseudoephedrine, or phenylpropanolamine for use in the illicit production of methamphet- amine, the Attorney General may, in the case of any person who is a manufacturer or distributor of such chemical in the chain of distribution re- ferred to in paragraph (1) (which person is re- ferred to in this subsection as a ‘‘foreign-chain distributor’’), request that such distributor pro- vide to the Attorney General information known to the distributor on the distribution of the chemical, including sales. (3) If the Attorney General determines that a foreign-chain distributor is refusing to cooper- ate with the Attorney General in obtaining the information referred to in paragraph (2), the At- torney General may, in accordance with proce- dures that apply under subsection (c), issue an order prohibiting the importation of ephedrine, pseudoephedrine, or phenylpropanolamine in any case in which such distributor is part of the chain of distribution for such chemical. Not later than 60 days prior to issuing the order, the Attorney General shall publish in the Federal Register a notice of intent to issue the order. During such 60-day period, imports of the chem- ical with respect to such distributor may not be restricted under this paragraph. (Pub. L. 91–513, title III, § 1018, as added Pub. L. 100–690, title VI, § 6053(a), Nov. 18, 1988, 102 Stat. 4314; amended Pub. L. 103–200, §§ 4(a), 5(a), 9(b), Dec. 17, 1993, 107 Stat. 2338–2340; Pub. L. 103–322, title XXXIII, § 330024(c), Sept. 13, 1994, 108 Stat. 2150; Pub. L. 109–177, title VII, §§ 716(a), (b)(1)(B), 721, Mar. 9, 2006, 120 Stat. 265, 267.) Editorial Notes AMENDMENTS 2006—Subsec. (b)(1). Pub. L. 109–177, § 716(a)(1), sub- stituted ‘‘or to a transaction that is an importation by a regular importer’’ for ‘‘or to an importation by a reg- ular importer’’. Subsec. (c)(1). Pub. L. 109–177, § 716(b)(1)(B), inserted ‘‘(without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred)’’ after ‘‘manufacture of a controlled sub- stance’’. Subsecs. (d) to (f). Pub. L. 109–177, § 716(a)(2), (3), added subsec. (d) and redesignated former subsecs. (d) and (e) as (e) and (f), respectively. Subsec. (g). Pub. L. 109–177, § 716(a)(4), added subsec. (g). Subsec. (h). Pub. L. 109–177, § 721, added subsec. (h). 1994—Subsecs. (b)(1), (2), (c)(1). Pub. L. 103–322, § 330024(c)(2), made technical amendment to directory language of Pub. L. 103–200, § 9(b). See 1993 Amendment notes below. Subsec. (e). Pub. L. 103–322, § 330024(c)(1), made tech- nical amendment to directory language of Pub. L. 103–200, § 5(a). See 1993 Amendment note below. 1993—Subsec. (b)(1). Pub. L. 103–200, § 9(b)(1)(A), as amended by Pub. L. 103–322, § 330024(c)(2), substituted ‘‘to an importation by a regular importer’’ for ‘‘regular supplier of the regulated person’’. Subsec. (b)(2). Pub. L. 103–200, § 9(b)(1)(B), as amended by Pub. L. 103–322, § 330024(c)(2), substituted ‘‘a cus- tomer of a regulated person or to an importer’’ for ‘‘a customer or supplier of a regulated person’’ and ‘‘the importer as a regular importer’’ for ‘‘regular supplier’’. Subsec. (c)(1). Pub. L. 103–200, § 9(b)(2), as amended by Pub. L. 103–322, § 330024(c)(2), substituted ‘‘regular im- porter’’ for ‘‘regular supplier’’. Subsec. (d). Pub. L. 103–200, § 4(a), added subsec. (d). Subsec. (e). Pub. L. 103–200, § 5(a), as amended by Pub. L. 103–322, § 330024(c)(1), added subsec. (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1994 AMENDMENT Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE Pub. L. 100–690, title VI, § 6053(b), Nov. 18, 1988, 102 Stat. 4315, provided that: ‘‘(1) Not later than 45 days after the date of the enact- ment of this Act [Nov. 18, 1988], the Attorney General shall forward to the Director of the Office of Manage- ment and Budget proposed regulations required by the amendment made by subsection (a) [enacting this sec- tion]. ‘‘(2) Not later than 55 days after the date of the enact- ment of this Act, the Director of the Office of Manage- ment and Budget shall— ‘‘(A) review such proposed regulations of the Attor- ney General; and ‘‘(B) forward any comments and recommendations for modifications to the Attorney General. ‘‘(3) Not later than 60 days after the date of the enact- ment of this Act, the Attorney General shall publish the proposed final regulations required by the amend- ment made by subsection (a). ‘‘(4) Not later than 120 days after the date of the en- actment of this Act, the Attorney General shall pro- mulgate final regulations required by the amendment made by subsection (a). ‘‘(5) Subsection (a) of section 1018 of the Controlled Substances Import and Export Act [subsection (a) of this section], as added by subsection (a) of this section, shall take effect 90 days after the promulgation of the final regulations under paragraph (4). ‘‘(6) Each regulated person shall provide to the Attor- ney General the identity of any regular customer or regular supplier of the regulated person not later than 30 days after the promulgation of the final regulations under paragraph (4). Not later than 60 days after the end of such 30-day period, each regular customer and regular supplier so identified shall be a regular cus- tomer or regular supplier for purposes of any applicable exception from the requirement of subsection (a) of such section 1018, unless the the [sic] Attorney General otherwise notifies the regulated person in writing.’’ Section effective 120 days after Nov. 18, 1988 [except subsec. (a), see above], see section 6061 of Pub. L. 100–690, set out as an Effective Date of 1988 Amendment note under section 802 of this title. EXCEPTION FOR IODINE TO IMPORTATION AND EXPORTATION REQUIREMENTS FOR LISTED CHEMICALS Pub. L. 104–237, title II, § 204(b), Oct. 3, 1996, 110 Stat. 3102, provided that: ‘‘(1) Iodine shall not be subject to the requirements for listed chemicals provided in section 1018 of the Con- trolled Substances Import and Export Act (21 U.S.C. 971). ‘‘(2) EFFECT OF EXCEPTION.—The exception made by paragraph (1) shall not limit the authority of the At- torney General to impose the requirements for listed chemicals provided in section 1018 of the Controlled Substances Import and Export Act (21 U.S.C. 971).’’ Page 911 TITLE 21—FOOD AND DRUGS § 1031 CHAPTER 14—ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND ACTIVITIES §§ 1001 to 1007. Repealed. Pub. L. 97–35, title V, § 587(a)(3), Aug. 13, 1981, 95 Stat. 480 Section 1001, Pub. L. 91–527, § 2, Dec. 3, 1970, 84 Stat. 1385; Pub. L. 93–422, § 2(b), Sept. 21, 1974, 88 Stat. 1154; Pub. L. 95–336, § 2, Aug. 4, 1978, 92 Stat. 451, set forth Congressional declaration of purpose for Alcohol and Drug Abuse Education Act. Section 1002, Pub. L. 91–527, § 3, Dec. 3, 1970, 84 Stat. 1386; Pub. L. 93–422, § 2(c), Sept. 21, 1974, 88 Stat. 1155; Pub. L. 95–336, §§ 3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S. Res. 30, Mar. 7, 1979; Pub. L. 96–88, title III, § 301(a)(1), (2)(Q), (b)(1), title V, § 507, Oct. 17, 1979, 93 Stat. 677, 678, 692, set forth grant and contract authority, etc., for projects and programs. Section 1003, Pub. L. 91–527, § 4, Dec. 3, 1970, 84 Stat. 1387; Pub. L. 93–422, § 2(d), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title III, § 301(a)(1), title V, § 507, Oct. 17, 1979, 93 Stat. 677, 692, related to recordkeeping require- ments, and access to and inspection of records. Section 1004, Pub. L. 91–527, § 5, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, § 2(e), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title V, § 508(i), Oct. 17, 1979, 93 Stat. 693, related to technical assistance to local agencies, etc. Section 1005, Pub. L. 91–527, § 6, Dec. 3, 1970, 84 Stat. 1388, related to nature of payments. Section 1006, Pub. L. 91–527, § 7, Dec. 3, 1970, 84 Stat. 1388, related to utilization of services and facilities of Federal agencies and public and private agencies and institutions. Section 1007, Pub. L. 91–527, § 8, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, § 2(f), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 95–336, § 5, Aug. 4, 1978, 92 Stat. 453; Pub. L. 96–88, title III, § 301(a)(1), (2)(Q), title V, § 507, Oct. 17, 1979, 93 Stat. 677, 678, 692, defined ‘‘Secretary’’ and ‘‘State’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF REPEAL Repeal effective Oct. 1, 1982, see section 587(a) of Pub. L. 97–35, set out as section 3863(a) of Title 20, Edu- cation. CHAPTER 15—EGG PRODUCTS INSPECTION Sec. 1031. Congressional statement of findings. 1032. Congressional declaration of policy. 1033. Definitions. 1034. Inspection of egg products. 1035. Sanitary operating practices in official plants. 1036. Pasteurization and labeling of egg products at official plants. 1037. Prohibited acts. 1038. Cooperation with appropriate State and other governmental agencies; utilization of em- ployees; reimbursement. 1039. Eggs and egg products not intended for use as human food; inspection; denaturing or oth- erwise identifying. 1040. Recordkeeping requirements; persons re- quired to maintain records; scope of disclo- sure; access to records. 1041. Enforcement provisions. 1042. Reporting of violation to United States attor- ney for institution of criminal proceedings; procedure; presentation of views. 1043. Rules and regulations; administration and en- forcement. 1044. Exemption of certain activities. 1045. Limitation on entry of eggs and egg products and other materials into official plants. 1046. Imports. 1047. Refusal or withdrawal of inspection services; hearing; grounds; person deemed to have re- sponsible connection with business; finality of order of Secretary; judicial review; other provisions for refusal of services unaffected. Sec. 1048. Administrative detention of violative arti- cles; duration; release; removal of official marks. 1049. Seizure and condemnation proceedings. 1050. Jurisdiction of district courts; United States as plaintiff in enforcement and restraining proceedings; subpenas for witnesses. 1051. Other Federal laws applicable for administra- tion and enforcement of chapter; prosecu- tion of inquiries; exercise of jurisdiction. 1052. State or local regulation. 1053. Inspection and administration costs. 1054. Annual report to Congressional committees. 1055. Authorization of appropriations. 1056. Separability. § 1031. Congressional statement of findings Eggs and egg products are an important source of the Nation’s total supply of food, and are used in food in various forms. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign com- merce. It is essential, in the public interest, that the health and welfare of consumers be pro- tected by the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products con- sumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulter- ated, or improperly labeled or packaged egg products and certain qualities of eggs is inju- rious to the public welfare and destroys markets for wholesome, not adulterated, and properly la- beled and packaged eggs and egg products and results in sundry losses to producers and proc- essors, as well as injury to consumers. Unwhole- some, otherwise adulterated, or improperly la- beled or packaged products can be sold at lower prices and compete unfairly with the whole- some, not adulterated, and properly labeled and packaged products, to the detriment of con- sumers and the public generally. It is hereby found that all egg products and the qualities of eggs which are regulated under this chapter are either in interstate or foreign commerce, or sub- stantially affect such commerce, and that regu- lation by the Secretary of Agriculture and the Secretary of Health and Human Services, and cooperation by the States and other jurisdic- tions, as contemplated by this chapter, are ap- propriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers. (Pub. L. 91–597, § 2, Dec. 29, 1970, 84 Stat. 1620; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in text, was in the original ‘‘this Act’’, meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chap- ter. For complete classification of this Act to the Code, see Short Title note set out below and Tables. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel-