21 U.S.C. § 1036 — Pasteurization and labeling of egg prod-

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 Page 916 TITLE 21—FOOD AND DRUGS § 1037 1 So in original. The comma probably should not appear. proposing to use the labeling or container does not accept the determination of the Secretary, such person may request a hearing, but the use of the labeling or container shall, if the Sec- retary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after re- ceipt of notice of such final determination, the person adversely affected thereby appeals to the United States court of appeals for the circuit in which such person has its principal place of business or to the United States Court of Ap- peals for the District of Columbia Circuit. The provisions of section 194 of title 7,1 shall be ap- plicable to appeals taken under this section. (Pub. L. 91–597, § 7, 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. § 1037. Prohibited acts (a)(1) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for trans- portation, in any business in commerce any re- stricted eggs, capable of use as human food, ex- cept as authorized by regulations of the Sec- retary under such conditions as he may pre- scribe to assure that only eggs fit for human food are used for such purpose. (2) No egg handler shall possess with intent to use, or use, any restricted eggs in the prepara- tion of human food for commerce except that such eggs may be so possessed and used when au- thorized by regulations of the Secretary under such conditions as he may prescribe to assure that only eggs fit for human food are used for such purpose. (b)(1) No person shall process any egg products for commerce at any plant except in compliance with the requirements of this chapter. (2) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for trans- portation, in commerce any egg products re- quired to be inspected under this chapter unless they have been so inspected and are labeled and packaged in accordance with the requirements of section 1036 of this title. (3) No operator of any official plant shall fail to comply with any requirements of section 1035(a) of this title or the regulations there- under. (4) No operator of any official plant shall allow any egg products to be moved from such plant if they are adulterated or misbranded and capable of use as human food. (c) No egg handler shall possess any eggs after the eggs have been packed into a container that is destined for the ultimate consumer unless the eggs are stored and transported under refrigera- tion at an ambient temperature of no greater than 45 degrees Fahrenheit, as prescribed by rules and regulations promulgated by the Sec- retary. (d) No person shall violate any provision of section 1039, 1040 or 1046 of this title. (e) No person shall— (1) manufacture, cast, print, lithograph, or otherwise make any device containing any of- ficial mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary; (2) forge or alter any official device, mark, or certificate; (3) without authorization from the Sec- retary, use any official device, mark, or cer- tificate, or simulation thereof, or detach, de- face, or destroy any official device or mark; or use any labeling or container ordered to be withheld from use under section 1036 of this title after final judicial affirmance of such order or expiration of the time for appeal if no appeal is taken under said section; (4) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certifi- cate; (5) knowingly possess, without promptly no- tifying the Secretary or his representative, any official device or any counterfeit, simu- lated, forged, or improperly altered official certificate or any device or label, or any eggs or egg products bearing any counterfeit, simu- lated, forged, or improperly altered official mark; (6) knowingly make any false statement in any shipper’s certificate or other nonofficial or official certificate provided for in the regu- lations prescribed by the Secretary; (7) knowingly represent that any article has been inspected or exempted, under this chap- ter, when, in fact, it has, respectively, not been so inspected or exempted; and (8) refuse access, at any reasonable time, to any representative of the Secretary of Agri- culture or the Secretary of Health and Human Services, to any plant or other place of busi- ness subject to inspection under any provi- sions of this chapter. (f) No person, while an official or employee of the United States Government or any State or local governmental agency, or thereafter, shall use to his own advantage, or reveal other than to the authorized representatives of the United States Government or any State or other gov- ernment in their official capacity, or as ordered by a court in a judicial proceeding, any informa- tion acquired under the authority of this chap- ter concerning any matter which is entitled to protection as a trade secret. (Pub. L. 91–597, § 8, Dec. 29, 1970, 84 Stat. 1626; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, § 1012(c), Dec. 13, 1991, 105 Stat. 1899.)