21 U.S.C. § 1034 — Inspection of egg products

Page 914 TITLE 21—FOOD AND DRUGS § 1034 lizing, cooling, freezing, drying, or packaging egg products. (x) The term ‘‘Secretary’’ means the Secretary of Agriculture or his delegate. (y) The term ‘‘State’’ means any State of the United States, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and the District of Columbia. (z) The term ‘‘United States’’ means the States. (Pub. L. 91–597, § 4, Dec. 29, 1970, 84 Stat. 1621; Pub. L. 102–571, title I, § 107(15), Oct. 29, 1992, 106 Stat. 4499.) 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. The Fair Packaging and Labeling Act, referred to in subsec. (h), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classi- fication of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables. The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (i) and (u), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. The effective date of this chapter, referred to in sub- sec. (r), means the effective date of Pub. L. 91–597. For such effective date, see Effective Date note set out under section 1031 of this title. The Agricultural Marketing Act of 1946, referred to in subsec. (r), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, which is classified generally to chapter 38 (§ 1621 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1621 of Title 7 and Tables. AMENDMENTS 1992—Subsec. (a)(2)(D). Pub. L. 102–571 substituted ‘‘379e’’ for ‘‘376’’. 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. § 1034. Inspection of egg products (a) Processing operations and establishments subject to coverage; rules and regulations For the purpose of preventing the entry into or flow or movement in commerce of, or the bur- dening of commerce by, any egg product which is capable of use as human food and is mis- branded or adulterated, the Secretary shall, whenever processing operations are being con- ducted, cause continuous inspection to be made, in accordance with the regulations promulgated under this chapter, of the processing of egg products, in each plant processing egg products for commerce, unless exempted under section 1044 of this title. Without restricting the appli- cation of the preceding sentence to other kinds of establishments within its provisions, any food manufacturing establishment, institution, or restaurant which uses any eggs that do not meet the requirements of section 1044(a)(1) of this title in the preparation of any articles for human food shall be deemed to be a plant proc- essing egg products, with respect to such oper- ations. (b) Authority of Secretary to retain, segregate, and reinspect eggs and egg products The Secretary, at any time, shall cause such retention, segregation, and reinspection as he deems necessary of eggs and egg products capa- ble of use as human food in each official plant. (c) Condemnation of adulterated products; de- struction or reprocessing; procedure upon appeal from determination of adulteration Eggs and egg products found to be adulterated at official plants shall be condemned and, if no appeal be taken from such determination of con- demnation, such articles shall be destroyed for human food purposes under the supervision of an inspector: Provided, That articles which may by reprocessing be made not adulterated need not be condemned and destroyed if so reprocessed under the supervision of an inspector and there- after found to be not adulterated. If an appeal be taken from such determination, the eggs or egg products shall be appropriately marked and seg- regated pending completion of an appeal inspec- tion, which appeal shall be at the cost of the ap- pellant if the Secretary determines that the ap- peal is frivolous. If the determination of con- demnation is sustained, the eggs or egg products shall be destroyed for human food purposes under the supervision of an inspector. (d) Inspection of business premises, facilities, in- ventory, operations, and records of egg han- dlers; inspection of records and inventory of others required to keep records; authority of Secretary of Health and Human Services to inspect food manufacturing establishments, institutions, and restaurants; access to places of business The Secretary shall cause such other inspec- tions to be made of the business premises, facili- ties, inventory, operations, and records of egg handlers, and the records and inventory of other persons required to keep records under section 1040 of this title, as he deems appropriate (and in the case of shell egg packers, packing eggs for the ultimate consumer, at least once each cal- endar quarter) to assure that only eggs fit for human food are used for such purpose, and oth- erwise to assure compliance by egg handlers and other persons with the requirements of section 1037 of this title, except that the Secretary of Health and Human Services shall cause such in- spections to be made as he deems appropriate to assure compliance with such requirements at food manufacturing establishments, institu- tions, and restaurants, other than plants proc- essing egg products. Representatives of said Sec- retaries shall be afforded access to all such places of business for purposes of making the in- spections provided for in this chapter. (e) Refrigeration and labeling requirements (1) Subject to paragraphs (2), (3), and (4), the Secretary shall make such inspections as the Page 915 TITLE 21—FOOD AND DRUGS § 1036 Secretary considers appropriate of a facility of an egg handler (including a transport vehicle) to determine if shell eggs destined for the ultimate consumer— (A) are being held under refrigeration at an ambient temperature of no greater than 45 de- grees Fahrenheit after packing; and (B) contain labeling that indicates that re- frigeration is required. (2) In the case of a shell egg packer packing eggs for the ultimate consumer, the Secretary shall make an inspection in accordance with paragraph (1) at least once each calendar quar- ter. (3) The Secretary of Health and Human Serv- ices shall cause such inspections to be made as the Secretary considers appropriate to ensure compliance with the requirements of paragraph (1) at food manufacturing establishments, insti- tutions, and restaurants, other than plants packing eggs. (4) The Secretary shall not make an inspection as provided in paragraph (1) on any egg handler with a flock of not more than 3,000 layers. (5) A representative of the Secretary and the Secretary of Health and Human Services shall be afforded access to a place of business referred to in this subsection, including a transport vehi- cle, for purposes of making an inspection re- quired under this subsection. (Pub. L. 91–597, § 5, Dec. 29, 1970, 84 Stat. 1624; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, § 1012(b), Dec. 13, 1991, 105 Stat. 1899.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in subsecs. (a) and (d), 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. (e). Pub. L. 102–237 added subsec. (e). Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in subsec. (d) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. EFFECTIVE DATE OF 1991 AMENDMENT Pub. L. 102–237, title X, § 1012(h), Dec. 13, 1991, 105 Stat. 1901, provided that: ‘‘This section and the amend- ments made by this section [amending this section and sections 1037, 1041, 1042, 1046, and 1052 of this title and enacting provisions set out as a note under section 1031 of this title] shall become effective 12 months after the Secretary of Agriculture promulgates final regulations implementing this section and the amendments.’’ [Final regulations were promulgated Aug. 20, 1998, ef- fective Aug. 27, 1999. See 63 F.R. 45663.] 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. § 1035. Sanitary operating practices in official plants (a) Premises, facilities, and equipment Each official plant shall be operated in accord- ance with such sanitary practices and shall have such premises, facilities, and equipment as are required by regulations promulgated by the Sec- retary to effectuate the purposes of this chapter, including requirements for segregation and dis- position of restricted eggs. (b) Refusal by Secretary to inspect noncon- forming plants The Secretary shall refuse to render inspec- tion to any plant whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section. (Pub. L. 91–597, § 6, Dec. 29, 1970, 84 Stat. 1625.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in subsec. (a), 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. 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. § 1036. Pasteurization and labeling of egg prod- ucts at official plants (a) Contents of label Egg products inspected at any official plant under the authority of this chapter and found to be not adulterated shall be pasteurized before they leave the official plant, except as otherwise permitted by regulations of the Secretary, and shall at the time they leave the official plant, bear in distinctly legible form on their shipping containers or immediate containers, or both, when required by regulations of the Secretary, the official inspection legend and official plant number, of the plant where the products were processed, and such other information as the Secretary may require by regulations to de- scribe the products adequately and to assure that they will not have false or misleading la- beling. (b) False or misleading or use of nonapproved la- beling or containers; determination by Sec- retary; procedures applicable; appeal No labeling or container shall be used for egg products at official plants if it is false or mis- leading or has not been approved as required by the regulations of the Secretary. If the Sec- retary has reason to believe that any labeling or the size or form of any container in use or pro- posed for use with respect to egg products at any official plant is false or misleading in any par- ticular, he may direct that such use be withheld unless the labeling or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person using or