21 U.S.C. § 1033 — Definitions

Page 912 TITLE 21—FOOD AND DRUGS § 1032 fare’’ in text pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Edu- cation. EFFECTIVE DATE Pub. L. 91–597, § 29, Dec. 29, 1970, 84 Stat. 1635, provided that: ‘‘The provisions of this Act [enacting this chap- ter, amending sections 633 and 636 of Title 15, Com- merce and Trade, and enacting provisions set out as notes under this section] with respect to egg products shall take effect six months after enactment [Dec. 29, 1970]. Otherwise, this Act shall take effect eighteen months after enactment.’’ SHORT TITLE Pub. L. 91–597, § 1, Dec. 29, 1970, 84 Stat. 1620, provided: ‘‘That this Act [enacting this chapter, amending sec- tions 633 and 636 of Title 15, Commerce and Trade, and enacting provisions set as notes under this section] may be cited as the ‘Egg Products Inspection Act’.’’ MAINTENANCE OF EGGS AT PROPER TEMPERATURE Pub. L. 102–237, title X, § 1012(a), Dec. 13, 1991, 105 Stat. 1899, provided that: ‘‘(1) FINDINGS.—Congress finds that— ‘‘(A) food borne illness is a serious health problem; ‘‘(B) its incidence can be reduced through proper handling of food; and ‘‘(C) eggs are perishable and therefore are particu- larly susceptible to supporting microbial growth if proper temperature controls are not maintained. ‘‘(2) PURPOSES.—It is the purpose of this section [amending sections 1034, 1037, 1041, 1042, 1046, and 1052 of this title and enacting provisions set out as a note under section 1034 of this title] to prescribe the tem- perature at which eggs are maintained in order to re- duce the potential for harmful microbial growth to pro- tect the health and welfare of consumers.’’ § 1032. Congressional declaration of policy It is hereby declared to be the policy of the Congress to provide for the inspection of certain egg products, restrictions upon the disposition of certain qualities of eggs, and uniformity of standards for eggs, and otherwise regulate the processing and distribution of eggs and egg prod- ucts as hereinafter prescribed to prevent the movement or sale for human food, of eggs and egg products which are adulterated or mis- branded or otherwise in violation of this chap- ter. (Pub. L. 91–597, § 3, Dec. 29, 1970, 84 Stat. 1621.) 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. § 1033. Definitions For purposes of this chapter— (a) The term ‘‘adulterated’’ applies to any egg or egg product under one or more of the fol- lowing circumstances— (1) if it bears or contains any poisonous or deleterious substance which may render it in- jurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (2)(A) if it bears or contains any added poi- sonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food; (B) if it is, in whole or in part, a raw agricul- tural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title; (C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title; (D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not otherwise deemed adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive, in or on such article, is prohibited by regulations of the Secretary in official plants; (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human food; (4) if it has been prepared, packaged, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; (5) if it is an egg which has been subjected to incubation or the product of any egg which has been subjected to incubation; (6) if its container is composed, in whole or in part, of any poisonous or deleterious sub- stance which may render the contents inju- rious to health; (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title; or (8) if any valuable constituent has been in whole or in part omitted or abstracted there- from; or if any substance has been substituted, wholly or in part therefor; or if damage or in- feriority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of great- er value than it is. (b) The term ‘‘capable of use as human food’’ shall apply to any egg or egg product, unless it is denatured, or otherwise identified, as required by regulations prescribed by the Secretary to deter its use as human food. (c) The term ‘‘commerce’’ means interstate, foreign, or intrastate commerce. (d) The term ‘‘container’’ or ‘‘package’’ in- cludes any box, can, tin, plastic, or other recep- tacle, wrapper, or cover. Page 913 TITLE 21—FOOD AND DRUGS § 1033 (1) The term ‘‘immediate container’’ means any consumer package; or any other container in which egg products, not consumer packaged, are packed. (2) The term ‘‘shipping container’’ means any container used in packaging a product packed in an immediate container. (e) The term ‘‘egg handler’’ means any person who engages in any business in commerce which involves buying or selling any eggs (as a poultry producer or otherwise), or processing any egg products, or otherwise using any eggs in the preparation of human food. (f) The term ‘‘egg product’’ means any dried, frozen, or liquid eggs, with or without added in- gredients, excepting products which contain eggs only in a relatively small proportion or his- torically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be ex- empted by the Secretary under such conditions as he may prescribe to assure that the egg ingre- dients are not adulterated and such products are not represented as egg products. (g) The term ‘‘egg’’ means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea. (1) The term ‘‘check’’ means an egg that has a broken shell or crack in the shell but has its shell membranes intact and contents not leak- ing. (2) The term ‘‘clean and sound shell egg’’ means any egg whose shell is free of adhering dirt or foreign material and is not cracked or broken. (3) The term ‘‘dirty egg’’ means an egg that has a shell that is unbroken and has adhering dirt or foreign material. (4) The term ‘‘incubator reject’’ means an egg that has been subjected to incubation and has been removed from incubation during the hatch- ing operations as infertile or otherwise unhatchable. (5) The term ‘‘inedible’’ means eggs of the fol- lowing descriptions: black rots, yellow rots, white rots, mixed rots (addled eggs), sour eggs, eggs with green whites, eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs containing embryo chicks (at or beyond the blood ring stage). (6) The term ‘‘leaker’’ means an egg that has a crack or break in the shell and shell mem- branes to the extent that the egg contents are exposed or are exuding or free to exude through the shell. (7) The term ‘‘loss’’ means an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains a bloody white, large meat spots, a large quantity of blood, or other foreign material. (8) The term ‘‘restricted egg’’ means any check, dirty egg, incubator reject, inedible, leaker, or loss. (h) The term ‘‘Fair Packaging and Labeling Act’’ [15 U.S.C. 1451 et seq.] means the Act so en- titled, approved November 3, 1966 (80 Stat. 1296), and Acts amendatory thereof or supplementary thereto. (i) The term ‘‘Federal Food, Drug, and Cos- metic Act’’ [21 U.S.C. 301 et seq.] means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto. (j) The term ‘‘inspection’’ means the applica- tion of such inspection methods and techniques as are deemed necessary by the responsible Sec- retary to carry out the provisions of this chap- ter. (k) The term ‘‘inspector’’ means: (1) any employee or official of the United States Government authorized to inspect eggs or egg products under the authority of this chapter; or (2) any employee or official of the govern- ment of any State or local jurisdiction author- ized by the Secretary to inspect eggs or egg products under the authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency. (l) The term ‘‘misbranded’’ shall apply to egg products which are not labeled and packaged in accordance with the requirements prescribed by regulations of the Secretary under section 1036 of this title. (m) The term ‘‘official certificate’’ means any certificate prescribed by regulations of the Sec- retary for issuance by an inspector or other per- son performing official functions under this chapter. (n) The term ‘‘official device’’ means any de- vice prescribed or authorized by the Secretary for use in applying any official mark. (o) The term ‘‘official inspection legend’’ means any symbol prescribed by regulations of the Secretary showing that egg products were inspected in accordance with this chapter. (p) The term ‘‘official mark’’ means the offi- cial inspection legend or any other symbol pre- scribed by regulations of the Secretary to iden- tify the status of any article under this chapter. (q) The term ‘‘official plant’’ means any plant, as determined by the Secretary, at which in- spection of the processing of egg products is maintained by the Department of Agriculture under the authority of this chapter. (r) The term ‘‘official standards’’ means the standards of quality, grades, and weight classes for eggs, in effect upon the effective date of this chapter, or as thereafter amended, under the Ag- ricultural Marketing Act of 1946 (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.). (s) The term ‘‘pasteurize’’ means the sub- jecting of each particle of egg products to heat or other treatments to destroy harmful viable micro-organisms by such processes as may be prescribed by regulations of the Secretary. (t) The term ‘‘person’’ means any individual, partnership, corporation, association, or other business unit. (u) The terms ‘‘pesticide chemical,’’ ‘‘food ad- ditive,’’ ‘‘color additive,’’ and ‘‘raw agricultural commodity’’ shall have the same meaning for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. (v) The term ‘‘plant’’ means any place of busi- ness where egg products are processed. (w) The term ‘‘processing’’ means manufac- turing egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabi- 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