The Code of Federal Regulations of the United States of America

spectfully decline to produce the record or information specified therein, on the ground that disclosure of such record or information is prohibited by this section.

(c) A person who desires the disclosure of any such record or information may make written request therefor, verified by oath, directed to the Commissioner of Food and Drugs, setting forth his interest in the matter sought to be disclosed and specifically designating the use to which such records or information will be put in the event of compliance with such request; Provided, That a written request therefor made by a health, food or drug officer, prosecuting attorney or member of the judiciary of any State, Territory or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is determined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that disclosure of any such record or information for the use so specifically designated will not be incompatible with the public interest and will not result in revealing confidential matters the request will be granted, and if testimony relating thereto is requested one or more employees of the Food and Drug Administration will be designated and directed to appear, in response to a subpoena or a subpoena duces tecum, and testify with respect thereto.

(Sec. 10, 29 Stat. 607, as amended, sec. 3, 44 Stat. 1102, sec. 9, 44 Stat. 1409, sec. 4, 49 Stat. 885, sec. 701, 52 Stat. 1055; 15 U. S. C. 409, 21 U. S. C. 50, 64, 143, 371) [20 F. R. 9554, Dec. 20, 1955]

Sec.

5.9 Labeling of foods in which salt containing anticaking agents or other substances is an ingredient.

AUTHORITY: The provisions of this Part 5 issued under sec. 403, 701(a), 52 Stat. 1047, 1055 as amended, 21 U.S.C. 343, 371 (a).

SOURCE: The provisions of this Part 5 appear at 29 F.R. 15285, Nov. 14, 1964, unless otherwise noted.

§ 5.1 Open containers.

(a) An open container is a container of rigid or semirigid construction, which is not closed by lid, wrapper, or otherwise.

(b) An open container of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than one dry quart, shall be exempt from the labeling requirements of subsections (e), (g) (2) (with respect to the name of the food specified in the definition and standard), and (i) (1) of section 403 of the act; but such exemption shall be on the condition that if two or more such containers are enclosed in a crate or other shipping package, such crate or package shall bear labeling showing the number of such containers enclosed therein and the quantity of the contents of each. § 5.2 Repacked, reprocessed, and relabeled foods.

Except as provided by §§ 5.3 and 5.4, a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the act if:

(a) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or

(b) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case

may be, of such food in such establishment as will insure, if such specifications are followed, that such food will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such food from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(c) The article is an egg product subject to a standard of identity promulgated in Part 42 of this chapter, is to be shipped under the conditions specified in paragraph (a) or (b) of this section and for the purpose of pasteurization or other treatment as required in such standard, and each container of such egg product bears a conspicuous tag or label reading "Caution-This egg product has not been pasteurized or otherwise treated to destroy viable Salmonella micro-organisms." In addition to safe and suitable bactericidal processes designed specifically for Salmonella destruction in egg products, the term "other treatment" in the first sentence of this paragraph shall include use in acidic dressings in the processing of which the pH is not above 4.1 and the acidity of the aqueous phase, expressed as acetic acid, is not less than 1.4 percent, subject also to the conditions that:

(1) The agreement required in paragraph (b) of this section shall also state that the operator agrees to utilize such unpasteurized egg products in the processing of acidic dressings according to the specifications for pH and acidity set forth in this paragraph, agrees not to deliver the acidic dressing to a user until at least 72 hours after such egg product is incorporated in such acidic dressing, and agrees to maintain for inspection adequate records covering such processing for 2 years after such processing.

(2) In addition to the caution statement referred to above, the container of such egg product shall also bear the statement "Unpasteurized

for use

in acidic dressings only," the blank being filled in with the applicable name of the eggs or egg product.

[29 F.R. 15285, Nov. 14, 1964, as amended at 31 F.R. 6491, Apr. 29, 1966]

§ 5.3

Conditions affecting expiration of exemptions.

(a) An exemption of a shipment or other delivery of a food under § 5.2(a) or (c) shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment become void ab initio if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(b) An exemption of a shipment or other delivery of a food under § 5.2(b) or (c) shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by § 5.2(b) or (c).

(1) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such paragraph.

[29 F.R. 15285, Nov. 14, 1964, as amended at 31 F.R. 6491, Apr. 29, 1966]

§ 5.4 Labeling of cheeses during curing and processing.

The word "processed" as used in this section shall include the holding of cheese in a suitable warehouse at a temperature of not less than 35° F. for the purpose of aging or curing to bring the cheese into compliance with requirements of an applicable definition and standard of identity. The exemptions provided for in § 5.2 shall apply to cheese which is, in accordance with the practice of the trade, shipped to a warehouse for aging or curing, on condition that the cheese is identified in the manner set forth in one of the applicable following paragraphs, and in such case the provisions of § 5.3 shall also apply:

(a) In the case of varieties of cheese for which definitions and standards of

identity require a period of aging whether or not they are made from pasteurized milk, each such cheese shall bear on the cheese a legible mark showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each cheese, on its wrapper or immediate container, shall be affixed a removable tag bearing the statement "Uncured cheese for completion of curing and proper labeling," the blank being filled in with the applicable name of the variety of cheese. In the case of swiss cheese, the date at which the preliminary manufacturing process had been completed and at which date curing commences is the date on which the shaped curd is removed from immersion in saturated salt solution as provided in the definition and standard of identity for swiss cheese, and such cheese shall bear a removable tag reading, "To be cured and labeled as 'swiss cheese', but if eyes do not form to be labeled as 'swiss cheese for manufacturing.'"

(b) In the case of varieties of cheeses which when made from unpasteurized milk are required to be aged for not less than 60 days, each such cheese shall ear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or its wrapper or immediate container shall be affixed a removable tag reading,

cheese made from unpasteurized milk. For completion of curing and proper labeling," the blank being filled in with the applicable name of the variety of cheese.

(c) In the case of cheddar cheese, washed curd cheese, colby cheese, granular cheese, and brick cheese made from unpasteurized milk, each such cheese shall bear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or Its wrapper or immediate container shall be affixed a removable tag reading cheese made from unpasteurized milk. For completion of curing and proper labeling, or for labeling cheese for manufactur

ing," the blank being filled in with the applicable name of the variety of cheese. § 5.5 Certain foods with added artificial sweetener not intended for special dietary use.

(a) A food, or class of food, to which an artificial sweetener has been added and which does not purport to be and is not represented as a food, or class of food, for special dietary use including the diets of diabetics shall be exempt from the requirements of § 125.5 of this chapter if:

(1) It cannot be prepared in a way to achieve its intended characteristics without the addition of the artificial sweetener as a substitute for sugar or other natural sweetener.

(2) As consumed, its caloric content is not less than 90 percent of the same food, or class of food, sweetened with natural substances only.

(3) Its label lists the nonnutritive artificial sweetener as an ingredient, and no other representations, direct or implied, are made for such food, or class of food, based on the nonnutritive value of the added artificial sweetener.

(4) An interested person desiring that such an exemption be made effective for such food, or class of food, has submitted an application for such an exemption to the Commissioner of Food and Drugs, supplying: Full information concerning the addition of the artificial sweetener; the proposed label and labeling for such food, or class of food; the reasons why he believes such food, or class of food, should be subject to this exemption; a sample of such food, or class of food; and, upon request, any other information concerning such food, or class of food, which the Commissioner deems necessary in order to reach a decision.

(5) Such an exemption has been made effective by the Commissioner. When the Commissioner makes effective an exemption for food, or class of food, in accordance with the provisions of this section, such food, or class of food, will be listed in this section.

(b) The provisions of paragraph (a) (4) and (5) of this section shall not apply to a poultry product subject to the provisions of the Poultry Products Inspection Act or to a meat product subject to the provisions of the Meat Inspection Act, provided that authorization

The label declaration of a harmless marker used to identify a particular manufacturer's product may result in unfair competition through revealing a trade secret. Exemption from the label declaration of such a marker is granted, therefore, provided that the following conditions are met:

(a) The person desiring to use the marker without label declaration of its presence has submitted to the Commissioner of Food and Drugs full information concerning the proposed usage and the reasons why he believes label declaration of the marker should be subject to this exemption; and

(b) The person requesting the exemption has received from the Commissioner of Food and Drugs a finding that the marker is harmless and that the exemption has been granted.

§ 5.7 Wrapped fish fillets.

(a) Wrapped fish fillets of nonuniform weight intended to be unpacked and marked with the correct weight at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirement of section 403(e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing and marking: Provided, That:

(1) The outside container bears a label declaration of the total net weight; and

(2) The individual packages bear a conspicuous statement "To be weighed at time of sale" and a correct statement setting forth the weight of the wrapper; and

Provided further, That it is the practice of the retail establishment to weigh and mark the individual packages with a correct net-weight statement prior to or at the point of retail sale. A statement of the weight of the wrapper shall be set forth so as to be readily read and understood, using such term as "wrapper tare

ounce," the blank being filled in with the correct average weight of the wrapper used.

(b) The act of delivering the wrapped fish fillets during the retail sale without the correct net-weight statement shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this section shall be construed as requiring net-weight statements for wrapped fish fillets delivered into institutional trade provided the outside container bears the required information.

§ 5.8 Bananas, wrapped clusters (consumer units).

(a) Wrapped clusters (consumer units) of bananas of nonuniform weight intended to be unpacked from a master carton or container and weighed at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirements of section 403 (e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing: Provided, That:

(1) The master carton or container bears a label declaration of the total net weight; and

(2) The individual packages bear a conspicuous statement "To be weighed at the time of sale" and a correct statement setting forth the weight of the wrapper; and

Provided, further, That it is the practice of the retail establishment to weigh the individual packages either prior to or at the time of retail sale.

(b) The act of delivering the wrapped clusters (consumer units) during the retail sale without an accurate net weight statement or alternatively without weighing at the time of sale shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this paragraph shall be construed as requiring net-weight statements for clusters (consumer units) delivered into institutional trade, provided that the master container or carton bears the required information.

§ 5.9 Labeling of foods in which salt containing anticaking agents or other substances is an ingredient.

Anticaking agents and other substances added to salt for the purpose of improving the physical properties of such salt are deemed to be incidental additives and are exempt from label declaration as ingredients of foods fabricated

from such salt and other ingredients when:

(a) The salt anticaking agents or substances added to otherwise improving the physical properties of salt are not food additives within the meaning of section 201 (s) of the Federal Food, Drug, and Cosmetic Act, are present at a level not greater than necessary to accomplish their intended physical effect, or if food additives, are used in salt in accordance with section 409 of the act and regulations thereunder.

(b) The classes of substances named in paragraph (a) of this section are present at nonfunctional and insignificant levels and do not exert any effect on the fabricated food containing such salt. [30 F.R. 15292, Dec. 10, 1965]