inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including invoice).

(e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading.

[32 F.R. 10781, July 21, 1967, as amended at 32 F.R. 13278, Sept. 20, 1967]

§ 1.8b Food labeling; declaration of net quantity of contents; when exempt. (a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The statement shall be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, or viscous, or a mixture or solid and liquid; except that such statement may be in terms of dry measure if the food is a fresh fruit, fresh vegetable, or other dry commodity that is customarily sold by dry measure. If there is a firmly established general consumer usage and trade custom of declaring the contents of a liquid by weight, or a solid, semisolid, or viscous product by fluid measure, it may be used. Whenever the Commissioner determines that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination in the case of a specific packaged food does not facilitate value comparisons by consumers and offers opportunity for consumer confusion, he will by regulation designate the appropriate term or terms to be used for such commodity.

(b) (1) Statements of weight shall be in terms of avoirdupois pound and ounce.

(2) Statements of fluid measure shall be in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall:

(1) In the case of frozen food that is sold and consumed in a frozen state, express the volume at the frozen temperature.

(11) In the case of refrigerated food

that is sold in the refrigerated state, express the volume at 40° F. (4° C.).

(iii) In the case of other foods, express the volume at 68° F. (20° C.).

(3) Statements of dry measure shall be in terms of the U.S. bushel of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions thereof.

(c) When the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such statement of weight, measure, or size of the individual units of the foods as will provide such information.

(d) The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places. A statement that includes small fractions of an ounce shall be deemed to permit smaller variations than one which does not inIclude such fractions.

(e) The declaration shall be located on the principal display panel of the label, and with respect to packages bearing alternate principal panels it shall be duplicated on each principal display panel.

(f) The declaration shall appear as a distinct item on the principal display panel, shall be separated (by at least a space equal to the height of the lettering used in the declaration) from other printed label information appearing above or below the declaration and (by at least a space equal to twice the width of the letter "N" of the style of type used in the quantity of contents statement) from other printed label information appearing to the left or right of the declaration. It shall not include any term qualifying a unit of weight, measure, or count (such as "jumbo quart" and "full gallon") that tends to exaggerate the amount of the food in the container. It shall be placed on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be dis

played: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the declaration of net quantity of contents meets the other requirements of this part.

(g) The declaration shall accurately reveal the quantity of food in the package exclusive of wrappers and other material packed therewith; provided that in the case of foods packed in containers designed to deliver the food under pressure, the declaration shall state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is included in the net quantity declaration.

(h) The declaration shall appear in conspicuous and easily legible boldface print or type in distinct contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that a declaration of net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is so formed on the surface. Requirements of conspicuousness and legibility shall include the specifications that:

(1) The ratio of height to width (of the letter) shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide).

(2) Letter heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter "o" or its equivalent that shall meet the minimum standards.

(3) When fractions are used, each component numeral shall meet one-half the minimum height standards.

(1) The declaration shall be in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:

(1) Not less than 16 inch in height on packages the principal display panel of which has an area of 5 square inches or less.

(2) Not less than 8 inch in height on packages the principal display panel of which has an area of more than 5 but not more than 25 square inches.

(3) Not less than 16 inch in height on packages the principal display panel of

which has an area of more than 2 not more than 100 square inches.

(4) Not less than 14 inch in heig packages the principal display par which has an area of more than square inches, except not less tha inch in height if the area is more 400 square inches.

Where the declaration is blown, bossed, or molded on a glass or p surface rather than by printing, ty or coloring, the lettering sizes spe in subparagraphs (1) through (4) o paragraph shall be increased by 1 an inch.

(j) On packages containing less 4 pounds or 1 gallon and labeled in of weight or fluid measure:

(1) The declaration shall be expr both in ounces, with identificatio weight or by liquid measure and, i plicable (1 pound or 1 pint or more lowed in parentheses by a declarati pounds for weight units, with an mainder in terms of ounces or con or decimal fractions of the pound examples set forth in paragraph (m and (2) of this section), or in the of liquid measure, in the largest y units (quarts, quarts and pints, or as appropriate) with any remaind terms of fluid ounces or common or mal fractions of the pint or quart examples in paragraph (m) (3) an of this section).

(2) If the net quantity of contents laration appears on a random pac that is a package which is one of shipment, or delivery of packages o same consumer commodity with va weights and with no fixed weight pa it may, when the net weight exce pound, be expressed in terms of p and decimal fractions of the pound ried out to not more than two de places. When the net weight does no ceed 1 pound, the declaration on the dom package may be in decimal frac of the pound in lieu of ounces (se ample in paragraph (m) (5) of section).

(3) The declaration may appea more than one line. The term weight" shall be used when statin net quantity of contents in term weight. Use of the terms "net" or contents" in terms of fluid measu numerical count is optional. It is cient to distinguish avoirdupois from fluid ounce through associati terms; for example, "Net wt. 6 oz

(b) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms 2 when used in regulations promulgated under that act.

(c) The definition of "package" in § 1.1b and of "principal display panel" in 88 1.7, 1.101a, and 1.201a; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in §§ 1.8 b(f), 1.102d(e), and 1.202b (f) to type size requirements for net quantity declaration in §§ 1.8b(i), 1.102(h), and 1.202b (i), to initial statement of ounces in the dual declaration of net quantity in §§ 1.8b (j) and (m), 1.102d (d) and (k), and 1.202b (j) and (m), to initial statement of inches in declaration of net quantity in §§ 1.102d(m) and 1.202b(o), to initial statement of square inches in declaration of net quantity in §§ 1.102d (n) and 1.202b (p) to prohibition of certain supplemental net quantity statements in §§ 1.8b(o), 1.102d(o), and 1.202b (q), and to servings representations in § 1.8c are provided for solely by the Fair Packaging and Labeling Act. The other requirements of this part are issued under both the Fair Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act, or by the latter act solely, and are not limited in their application by section 10 of the Fair Packaging and Labeling Act.

[82 F.R. 10780, July 21, 1967, as amended at 38 F.R. 9482, June 28, 1968]

§ 1.la Foods, drugs, devices, and cos metics; labeling; procedure for requesting variations and exemptions from required label statements. Section 403 (e) of the act (in this Part 1, the term "act" means the Federal Food, Drug, and Cosmetic Act) provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 403 (1) of the act provides for the establishment by regulation of exemptions from the required declaration of ingredients where such declaration is impracticable, or results in deception or unfair competition. Section 502(b) of the act provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 602(b) of the act provides for the establishment by regulation

of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 5(b) of the Fair Packaging and Labeling Act provides for the establishment by regulation of exemptions from certain required declarations of net quantity of contents, identity of commodity, identity and location of manufacturer, packer, or distributor, and from declaration of net quantity of servings represented, based on a finding that full compliance with such required declarations is impracticable or not necessary for the adequate protection of consumers, and a further finding that the nature, form, or quantity of the packaged consumer commodity or other good and sufficient reasons justify such exemptions. The Commissioner, on his own initiative or on petition of an interested person, may propose such findings and an exemption. The procedure followed and the criteria used in acting upon exemption requests of interested persons are as follows:

(a) If the petitioner shows that he is an interested person and furnishes reasonable grounds for his proposal, the Commissioner shall publish the proposal in the FEDERAL REGISTER and afford opportunity for interested persons to comment on it. After a study of all the facts available and of the comments received, the Commissioner will act upon the proposal and publish an order, pursuant to section 701(e) of the act, to which objection may be taken by persons who would be adversely affected.

(b) Practical administration of the law requires that there be a substantial showing of merit before any proposal is published. In evaluating proposals submitted by petitioners for initiating actions, it will be the policy of the Food and Drug Administration to consider that reasonable grounds have been furnished when:

(1) The proposal includes or is accompanied by a statement of the facts that the petitioner asserts he can substantiate by evidence in the event the proceedings lead to a public hearing.

(2) The declared facts furnish substantial support of the proposal and warrant a conclusion that the proposal is reasonable.

(3) The proposal if adopted would not unduly impinge upon the consumer's right to information essential to efficient marketing and to the making of value comparisons and would not otherwise

promote deception or unfair competition.

(4) Full compliance with the declarations required by law would be impracticable, deceptive, or otherwise unneces

sary.

(c) Opportunity will be given to amend petitions regarded as inadequate.

(d) At any time prior to the issuance of an order acting on his proposal under section 701(e) (1) of the act, the petitioner may withdraw his petition without prejudice to a future filing. Notice of withdrawal of the petition and termination of the rulemaking proceeding will be published in the FEDERAL REGISTER.

(e) Established exemptions are set forth in § 1.1c.

[82 F.R. 10730, July 21, 1967]

§ 1.1b Packages; definition; presence of mandatory label information.

The term "package" means any container or wrapping in which any food, drug, device, or cosmetic is enclosed for use in the delivery or display of such commodities to retail purchasers, but does not include:

(a) Shipping containers or wrappings used solely for the transportation of any such commodity in bulk or in quantity to manufacturers, packers, processors, or wholesale or retail distributors;

(b) Shipping containers or outer wrappings used by retailers to ship or deliver any such commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity; or

(c) Containers subject to the provisions of the Act of August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231233), the Act of March 4, 1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of May 21, 1928 (45 Stat. 685, as amended; 15 U.S.C. 257-2571).

(d) Containers used for tray pack displays in retail establishments.

(e) Transparent wrappers or containers which do not bear written, printed, or graphic matter obscuring the label information required by this part.

A requirement contained in this part that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or information also appears on the outer container or wrapper of the retail package of the

article, or, as stated in paragraph (e) of this section, such information is easily legible by virtue of the transparency of the outer wrapper or container. Where & consumer commodity is marketed in a multiunit retail package bearing the mandatory label information as required by this part and the unit containers are not intended to be sold separately, the net weight placement requirement of § 1.8b (f) applicable to such unit containers is waived if the units are in compliance with all the other requirements of this part.

[32 F.R. 10730, July 21, 1967, as amended at 32 F.R. 13277, Sept. 20, 1967]

§ 1.1c Exemptions from required label

statements.

The following exemptions are granted from label statements required by this part:

(a) Foods. (1) While held for sale, a food shall be exempt from the required declaration of net quantity of contents specified in this part if said food is received in bulk containers at a retail establishment and is accurately weighed, measured, or counted either within the view of the purchaser or in compliance with the purchaser's order.

(2) Random food packages, as defined in § 1.8b(j), bearing labels declaring net weight, price per pound or per specified number of pounds, and total price shall be exempt from the type size, dual declaration, and placement requirements of § 1.8b if the accurate statement of net weight is presented conspicuously on the principal display panel of the package. In the case of food packed in random packages at one place for subsequent shipment and sale at another, the price sections of the label may be left blank provided they are filled in by the seller prior to retail sale. This exemption shall also apply to uniform weight packages of cheese and cheese products labeled in the same manner and by the same type of equipment as random food packages exempted by this subparagraph except that the labels shall bear a declaration of price per pound and not price per specified number of pounds.

(3) Individual serving-size packages of foods containing less than 1⁄2 ounce or less than 2 fluid ounce for use in restaurants, institutions, and passenger carriers, and not intended for sale at retail, shall be exempt from the required declaration of net quantity of contents specified in this part.