the principal display panel thereof shall be considered as the label.

(b) No label, container, or packaging material bearing official identification may be printed or prepared for use until the printers' or other final proof has been approved by the Administrator in accordance with the regulations in this part, the Egg Products Inspection Act, the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations promulgated under these acts. Copies of each label submitted for approval shall be accompanied by:

(1) A statement showing by their common or usual names the kinds and percentages of the ingredients comprising the egg product in the form in which it is to be used (1.e., liquid or dried). Approximate percentages (range) may be given in cases where the percentages may vary from time to time.

(2) When required, scientific data demonstrating that the substance or mixture is safe and effective for its intended use and does not promote deception or cause the product to be otherwise adulterated or misbranded.

(c) Containers of product bearing official identification shall display the following information:

(1) The common or usual name, if any, and if the product is comprised of two or more ingredients, such ingredients shall be listed in the order of descending proportions. When water (excluding that used to reconstitute dehydrated ingredients back to their normal composition) is added to a liquid or frozen egg product or to an ingredient of such products (in excess of the normal water content of that ingredient), the total amount of water added, including the water content of any cellulose or vegetable gums used, shall be expressed as a percentage of the total product volume in the ingredient statement on the label.

(2) The name, address, and ZIP code of the packer or distributor. When the distributor is shown, it shall be qualified by such terms as "packed for," "distributed by," or "distributors";

(3) The lot number or production code number;

(4) The net contents;

(5) Official identification and plant number;

(6) Egg products which are produced in an official plant from edible shell eggs

of other than current production or from other egg products produced from shell eggs of other than current production, shall be clearly and distinctly labeled in close proximity to the common or usual name of the product, e.g., "Manufactured from eggs of other than current production";

(7) Egg products produced from edible shell eggs or the egg product produced from such shell eggs of the turkey, duck, goose, or guinea shall be clearly and distinctly labeled as to the common or usual name of the product indicating the type of eggs or egg products used in the product, e.g., "Frozen whole turkey eggs," "Frozen whole chicken and turkey eggs." Egg products labeled without qualifying words as to the type of shell egg used in the product shall be produced only from the edible shell egg of the domesticated chicken or the egg product produced from such shell eggs.

(d) Liquid or frozen egg products identified as whole eggs and prepared other than in natural proportions, as so broken from the shell, shall have a total egg solids content of 24.70 percent or greater.

(e) Nutrition information may be included on the label of egg products, providing such labeling complies with the provisions of 21 CFR Part 1, Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Since these regulations have different requirements for consumer packaged products than for bulk packaged egg products not for sale or distribution to household consumers, label submission shall be accompanied with information indicating whether the label covers consumer packaged or bulk packaged product. Nutrition labeling is required when nutrients, such as proteins, vitamins, and minerals are added to the product, or when a nutritional claim or information is presented on the labeling, except for the following which are exempt from nutrition labeling requirements:

(1) Egg products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to household consumers in such bulk form or containers.

(2) Products containing an added vitamin, mineral, or protein, or for which a nutritional claim is made on the label, or in advertising, which is supplied for in

stitutional food use only: Provided, That the manufacturer or distributor provides the required nutrition information directly to those institutions.

(3) Any nutrient (s) included in product solely for technological purpose may be declared solely in the ingredients statement, without complying with nutrition labeling, if the nutrient(s) is otherwise not referred to in labeling or in advertising. Labels will not be approved by the Department without comments from the Food and Drug Administration regarding nutritional claims, formulation, and test data.

(f) If the Administrator has reason to believe that the statement on formulation shows the product to be adulterated or misbranded or that any labeling, or the size or form of any container in use or proposed for use in respect to egg products at any official plant is false or misleading in any way, he may direct that such use be withheld unless the labeling or container is modified in such a manner as he may prescribe so that it Iwill not be false or misleading, and/or the formulation of the product is altered in such a manner that he may prescribe so that it is not adulterated, or would not cause misbranding. Any person so denied the approval of any label shall be notified promptly of the reasons for the denial on a form approved by the Administrator. If the person using or proposing to use the label does not accept the determination of the Administrator, he may request a hearing by filing with the Administrator within 10 days after receiving the notice of denial, a written application for a hearing setting forth specifically, the errors alleged to have been made by the Administrator in denying approval of the label. The use of the label shall be withheld pending hearing and final determination by the Administrator if the Administrator so directs. Hearings held pursuant to this subsection shall be presided at by the Administrator. The applicant shall be given the opportunity to present evidence both oral and written in support of his allegation that the Administrator erred in denying approval of the label. The notice of denial together with all other available data and information used as a basis for such denial shall be considered part of the record. The Administrator may take official notice of such matters as are

Judicially noticed by the Courts of the United States and of any other matter of technical, scientific, or commercial fact of established character. The Administrator shall make his final determination with respect to the matter upon the basis of evidence before him. Such determination shall be conclusive unless, within 30 days after the receipt of notice of such final determination, the person adversely affected thereby appeals to the U.S. Court of Appeals for the circuit in which he has his principal place of business, or to the U.S. Court of Appeals for the District of Columbia Circuit. The provisions of section 204 of the Packers and Stockyards Act of 1921, as amended, shall be applicable to appeals taken under this section.

[37 FR 6658, Apr. 1, 1972, as amended at 40 FR 20058, May 8, 1975]

§ 59.412 Form of official identification symbol and inspection mark.

(a) The shield set forth in Figure 1 containing the letters "USDA" shall be the official identification symbol for purposes of this part and, when used, imitated, or simulated in any manner in connection with a product, shall be deemed to constitute a representation that the product has been officially inspected.

(b) The inspection mark which is to be used on containers of edible egg products shall be contained within the outline of a shield and with the wording and design set forth in Figure 2 of this section, except the plant number may be omitted from the official identification if applied elsewhere on the container.

USDA

FIGURE 1.

USDA

INSPECTED

EGG PRODUCTS

PLANT 42

FIGURE

[36 FR 9814, May 28, 1971, as amended at 40 FR 20058, May 8, 1975]

§ 59.414 Products bearing the official inspection mark.

Egg products which are permitted to bear the inspection mark shall be processed in an official plant from edible shell eggs or other edible egg products and may contain other edible ingredients. The official mark shall be printed or lithographed and applied as a part of the principal display panel of the container but shall not be applied to a detachable cover.

§ 59.415 Use of other official identification.

Other official identification as shown in this section shall be printed or lithographed and applied as a part of the principal display panel, but shall not be applied to a detachable cover. The plant number may be omitted from the identification if applied elsewhere on the label or container. Such products shall meet all requirements for egg products which are permitted to bear the official inspection mark shown in § 59.412, except for pasteurization, heat treatment, or other such methods of treatment approved by the Administrator. Such products shall not be released into consuming channels until they have been subjected to pasteurization, heat treatment, or other approved methods of treatment.

(a) All nonpasteurized egg products, except as provided in paragraph (b) of this section, shipped from an official plant in packaged form shall be marked with the identification set forth in Figure 3 of this section. After pasteuriza

(a) Containers or labels which bear official identification approved for use pursuant to § 59.411 shall be used only for the purpose for which approved. Any unauthorized use or disposition of approved containers or labels which bear any official identification may result in cancellation of the approval and denial of the use of containers or labels bearing official identification and may subject such violator to the penalties and denial of the benefits of the Act;

(b) The use of simulations or imitations of any official identification by any person is prohibited;

(c) Once a year each applicant shall submit to the Administrator a list of approved labels that have become obsolete, accompanied with a statement that such approvals are no longer desired. The approvals shall be identified by the date of approval, approval number, and the name of the product.

(d) Upon termination of inspection service in an official plant pursuant to these regulations, all labels, seals, tags,

or packaging material bearing official identification shall, under the supervision of a person designated by the Service, either be destroyed or the official identification completely obliterated, or inventoried and sealed in a manner acceptable to the Service.

[36 FR 9814, May 28, 1971, as amended at 40 FR 20059, May 8, 1975]

§ 59.418 Supervision of marking and packaging.

(a) Evidence of label approval. No inspector shall authorize the use of official identification on any inspected product unless he has on file evidence that such official identification or packaging material bearing such official identification has been approved in accordance with the provisions of § 59.411.

(b) Affixing of official identification. No official identification shall be, or caused to be affixed to or placed on any product or container except by an inspector or under the supervision of an inspector or other person authorized by the Administrator. All such products shall have been inspected in accordance with these regulations. The inspector shall have supervision over the use and handling of all material bearing any official identification.

(c) Labels for products sold under Government contract. The inspector in the official plant may approve use of labels for containers of product sold under a contract specification to governmental agencies when such product is not offered for resale to the general public: Provided, That the contract specifications have been approved by the Administrator and include complete specific requirements with respect to labeling and are made available to the inspector. § 59.419 Reuse of containers bearing official identification prohibited.

The reuse, by any person, of containers bearing official identification is prohibited unless such identification is applicable in all respects to product being packed therein. In such instances, the container and label may be used provided the packaging is accomplished under the supervision of an inspector and the container is in compliance with § 59.504 (k).

INSPECTION, REINSPECTION, CONDEMNATION, AND RETENTION Inspection.

§ 59.420

(a) Continuous inspection shall be made, pursuant to these regulations, of

the processing of egg products in each official plant processing egg products for commerce unless exempted under

59.100. Inspections, certifications, or specification-type gradings, and other inspections which may be requested by the official plant and are in addition to the normal inspection requirements and functions for the processing, production, or certification of a wholesome egg product under this part, shall be made pursuant to the voluntary egg products inspection service (Part 55 of this chapter).

(b) Any food manufacturing establishment or institution which uses any eggs that do not meet the requirements of § 59.100 (a) in the preparation of any articles for human food shall be deemed to be a plant processing egg products requiring continuous inspection under this part.

(c) Any product which is prepared under inspection in an official plant shall be inspected in such plant as often as the inspector deems necessary in order to ascertain if the product is unadulterated, wholesome, properly labeled, and fit for human food at the time it leaves the plant. Upon any such inspection, if any product or portion thereof is found to be adulterated, unwholesome, or otherwise unfit for human food, such product or portion thereof shall be condemned and shall receive such treatment as provided in § 59.422.

Eggs and egg products found to be adulterated at official plants shall be condemned and, if no appeal be taken from such determination of condemnation, 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 thereafter found to be not adulterated. If an appeal is requested, the eggs or egg products shall be appropriately marked and segregated pending completion of an appeal inspection. The appeal shall be at the cost of the appellant if the Administrator determines that the appeal is frivolous, as defined in § 59.370. § 59.424

Reinspection.

(a) No egg product may be brought into an official plant except as provided in § 59.430 (b) unless it has been prepared and handled in accordance with these

regulations, and the container of such product is marked so as to identify the article as so inspected in accordance with this part.

(b) All egg products shall be reinspected by an inspector at the time they are brought into the official plant. Upon reinspection, if any such product or portion thereof is found to be unsound, unwholesome, adulterated, or otherwise unfit for human food, such product or portion thereof, shall be condemned and shall receive such treatment as provided in § 59.422, and shall, in the case of other products be disposed of according to applicable law.

Retention tags or other devices and methods as may be approved by the Administrator shall be used for the identification and control of products which are not in compliance with the regulations or are held for further examination, and any equipment, utensils, rooms or compartments which are found to be unclean or otherwise in violation of the regulations. No product, equipment, utensil, room, or compartment shall be released for use until it has been made acceptable. Such identification shall not be removed by anyone other than an inspector.

ENTRY OF MATERIAL INTO OFFICIAL EGG PRODUCTS PLANTS

(a) The Administrator shall limit the entry of eggs and egg products and other materials into official plants under such conditions as he may prescribe to assure that allowing the entry of such articles will be consistent with the purposes of the Act and these regulations.

(b) Inedible egg products may be brought into an official plant for storage and reshipment: Provided, they are handled in such a manner that adequate segregation and inventory controls are maintained at all times. Inedible egg products may be processed in official plants: Provided, That prior approval is obtained from the Administrator and under such conditions and time limitations as the Administrator may specify. The processing of inedible egg products shall be done under conditions which will not affect the processing of edible products, such as processing in separate areas, or at times when no edible product is being processed. All equipment and processing areas must be thoroughly

(a) Substances and ingredients used in the manufacture or preparation of any egg product capable of use as human food shall be clean, wholesome, and unadulterated.

(b) The use of chemical additives in egg products shall be permitted only when they are approved by the Administrator. The Administrator may require, in addition to listing the ingredients, a declaration of the additive, and the purpose of its use.

(c) Chemical additives to be used in the preparation of egg products will be approved only if they comply with the following criteria:

(1) The additive shall be safe under the conditions of its intended use.

(2) The additive shall not promote deception or cause the product to be otherwise adulterated or unwholesome. Scientific data acceptable to the Administrator showing that the additive meets the criteria specified in this paragraph (c) shall be submitted by the person interested in having the additive approved.

(d) Containers and packing or packaging materials in which shell eggs are received into the official plant shall be free from odors and materials which could contaminate or adulterate the eggs or egg products.

§ 59.440 Processing ova.

poultry

(a) Ova from slaughtered may be brought into the official plant for processing: Provided, That the ova is from wholesome poultry inspected in a plant operating under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and such product is harvested in a sanitary manner, properly handled, cooled, packaged and labeled: And provided further, That such product is wholesome and the containers of such product bear official identification which assures the provisions of this paragraph have been met.

(b) The ova and products containing ova shall be processed, cooled, and pasteurized in the official plant in the same manner as liquid, frozen, or dried yolk products.

(c) The labeling for all products containing ova shall be approved by the Administrator prior to use.