21 U.S.C. § 1044 — Exemption of certain activities

Page 919 TITLE 21—FOOD AND DRUGS § 1044 Editorial Notes REFERENCES IN TEXT This chapter, referred to in subsecs. (b), (c)(1)(A), and (e), was in the original ‘‘this Act’’, meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables. AMENDMENTS 1991—Subsec. (a). Pub. L. 102–237, § 1012(d)(1), (2), sub- stituted ‘‘$5,000’’ for ‘‘$1,000’’ in first sentence, and re- designated last sentence, relating to scope of liability for violations of section 1037 of this title, as subsec. (d). Subsec. (b). Pub. L. 102–237, § 1012(d)(4), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (e). Subsec. (c). Pub. L. 102–237, § 1012(d)(5), added subsec. (c). Former subsec. (c) redesignated (b). Subsec. (d). Pub. L. 102–237, § 1012(d)(2), designated last sentence of subsec. (a), relating to scope of liabil- ity for violations of section 1037 of this title, as subsec. (d). Subsec. (e). Pub. L. 102–237, § 1012(d)(3), redesignated subsec. (b) as (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1991 AMENDMENT Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title. EFFECTIVE DATE For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title. § 1042. Reporting of violation to United States at- torney for institution of criminal pro- ceedings; procedure; presentation of views Before any violation of this chapter is re- ported by the Secretary of Agriculture or Sec- retary of Health and Human Services to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated pro- ceeding. Nothing in this chapter shall be con- strued as requiring the Secretary of Agriculture or Secretary of Health and Human Services to report for criminal prosecution violations of this chapter whenever he believes that the pub- lic interest will be adequately served and com- pliance with this chapter obtained by a suitable written notice of warning or an action to assess civil penalties. (Pub. L. 91–597, § 13, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, § 1012(e), Dec. 13, 1991, 105 Stat. 1900.) 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 under section 1031 of this title and Tables. AMENDMENTS 1991—Pub. L. 102–237 inserted ‘‘or an action to assess civil penalties’’ before period at end. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted in text for ‘‘Secretary of Health, Education, and Welfare’’ pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Edu- cation. EFFECTIVE DATE OF 1991 AMENDMENT Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title. EFFECTIVE DATE For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title. § 1043. Rules and regulations; administration and enforcement The Secretary shall promulgate such rules and regulations as he deems necessary to carry out the purposes or provisions of this chapter, and shall be responsible for the administration and enforcement of this chapter except as otherwise provided in section 1034(d) of this title. (Pub. L. 91–597, § 14, Dec. 29, 1970, 84 Stat. 1629.) 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 under section 1031 of this title and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title. § 1044. Exemption of certain activities (a) Regulation for exemptions The Secretary may, by regulation and under such conditions and procedures as he may pre- scribe, exempt from specific provisions of this chapter— (1) the sale, transportation, possession, or use of eggs which contain no more restricted eggs than are allowed by the tolerance in the official standards of United States consumer grades for shell eggs; (2) the processing of egg products at any plant where the facilities and operating proce- dures meet such sanitary standards as may be prescribed by the Secretary, and where the eggs received or used in the manufacture of egg products contain no more restricted eggs than are allowed by the official standards of United States consumer grades for shell eggs, and the egg products processed at such plant; (3) the sale of eggs by any poultry producer from his own flocks directly to a household Page 920 TITLE 21—FOOD AND DRUGS § 1045 1 So in original. Probably should be ‘‘subsection (a)(2) or (6)’’. consumer exclusively for use by such con- sumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph; (4) the processing of egg products by any poultry producer from eggs of his own flocks’ production for sale of such products directly to a household consumer exclusively for use by such consumer and members of his house- hold and his nonpaying guests and employees, and the egg products so processed when han- dled in accordance with this paragraph; (5) the sale of eggs by shell egg packers on his own premises directly to household con- sumers for use by such consumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph; (6) for such period of time (not to exceed two years) during the initiation of operations under this chapter as the Secretary deter- mines that it is impracticable to provide in- spection, the processing of egg products at any class of plants and the egg products processed at such plants; and (7) the sale of eggs by any egg producer with an annual egg production from a flock of three thousand or less hens. (b) Plants located in noncontiguous areas of United States The Secretary shall, by regulation and under such procedures as he may prescribe, exempt any plant located within noncontiguous areas of the United States from specific provisions of this chapter, where, despite good faith efforts by the owner of such plant, such owner has not been able to bring his plant into full compliance with this chapter: Provided, That in order to pro- vide at least minimum standards for the protec- tion of the public health, whenever processing operations are being conducted at any such plant, continuous inspection shall be main- tained to assure that it is operated in a sanitary manner. No exemption under this subsection shall be granted for a period extending beyond December 31, 1971. (c) Suspension or termination of exemptions The Secretary may immediately suspend or terminate any exemption under paragraph (a)(2) or (6) 1 of this section at any time with respect to any person, if the conditions of exemption prescribed by this section or the regulations of the Secretary are not being met. The Secretary may modify or revoke any regulation granting exemption under this chapter whenever he deems such action appropriate to effectuate the purposes of this chapter. (Pub. L. 91–597, § 15, Dec. 29, 1970, 84 Stat. 1629; Pub. L. 92–67, Aug. 6, 1971, 85 Stat. 173.) 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 under section 1031 of this title and Tables. AMENDMENTS 1971—Subsecs. (b), (c). Pub. L. 92–67 added subsec. (b) and redesignated former subsec. (b) as (c). Statutory Notes and Related Subsidiaries EFFECTIVE DATE For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title. § 1045. Limitation on entry of eggs and egg prod- ucts and other materials into official plants The Secretary may limit the entry of eggs and egg products and other materials into official plants under such conditions as he may pre- scribe to assure that allowing the entry of such articles into such plants will be consistent with the purposes of this chapter. (Pub. L. 91–597, § 16, Dec. 29, 1970, 84 Stat. 1630.) 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 under section 1031 of this title and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title. § 1046. Imports (a) Authorization for importation of restricted eggs; prerequisites for importation of egg products; treatment as domestic articles sub- ject to this chapter; marking and labeling ex- emption for personal consumption (1) No restricted eggs capable of use as human food shall be imported into the United States except as authorized by regulations of the Sec- retary. (2) No egg products capable of use as human food shall be imported into the United States unless they were processed under an approved continuous inspection system of the government of the foreign country of origin or subdivision thereof and are labeled and packaged in accord- ance with, and otherwise comply with the stand- ards of this chapter and regulations issued thereunder applicable to such articles within the United States. (3) No eggs packed into a container that is des- tined for the ultimate consumer shall be im- ported into the United States unless the eggs are accompanied by a certification that the eggs have at all times after packaging been stored and transported under refrigeration at an ambi- ent temperature of no greater than 45 degrees Fahrenheit, as required by sections 1034(e) and 1037(c) of this title.