"Target tissue" means the edible tissue selected to monitor for residues in the target animals, including, where appropriate, milk or eggs.

"Test animals” means the species selected for use in the toxicity tests.

"Threshold assessment" means FDA's review of data and information about a sponsored compound to determine whether chronic bioassays in test animals are necessary to resolve questions concerning the carcinogenicity of the compound.

§ 500.84 Operational definition of no residue.

(a) On the basis of the results of the chronic bioassays and other information, FDA will determine whether any of the substances tested are carcinogenic.

(b) If FDA concludes that the results of the bioassays do not establish carcinogenicity, then FDA will not subject the sponsored compound to the remainder of the requirements of this subpart.

(c) For each sponsored compound that FDA decides should be regulated as a carcinogen, FDA will analyze the data from the bioassays using a statistical extrapolation procedure.

(1) For each substance tested in separate bioassays, FDA will calculate the concentration of the residue of carcinogenic concern that corresponds to a maximum lifetime risk to the test animal of 1 in 1 million. FDA will designate the lowest value obtained as S.. (2) FDA will consider that "no residue" of the compound remains in the edible tissue when conditions of use of the sponsored compound, including any required preslaughter withdrawal period or milk discard time, ensure that the concentration of the residue of carcinogenic concern in the total diet of people will not exceed S.. Because the total diet is not derived from food-producing animals, FDA will make corrections for food intake. FDA will designate as Sm the concentration of residue of carcinogenic concern that is permitted in a specific edible product.

§ 500.86 Marker residue and target tissue. (a) For each edible tissue, the sponsor shall measure the depletion of the

residue of carcinogenic concern until its concentration is at or below Sm.

(b) In one or more edible tissues, the sponsor shall also measure the depletion of one or more potential marker residues until the concentration of the residue of carcinogenic concern is at or below Sm

(c) From these data, FDA will select a target tissue and a marker residue and designate the concentration of marker residue (R) that the regulatory method must be capable of measuring in the target tissue. FDA will select Rm such that the absence of the marker residue in the target tissue above Rm can be taken as confirmation that the residue of carcinogenic concern does not exceed Sm in each of the edible tissues and, therefore, that the residue of carcinogenic concern in the diet of people does not exceed S..

(d) When a compound is to be used in milk- or egg-producing animals, milk or eggs must be the target tissue in addition to the tissue selected to monitor for residues in the edible carcass.

(Information collection requirements approved by the Office of Management and Budget under control number 0910-0228)

§ 500.88 Regulatory method.

(a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue.

(b) The regulatory method must reliably measure and confirm the identity of the marker residue in the target tissue at concentrations equal to and above Rm.

(c) FDA will publish in the FEDERAL REGISTER the complete regulatory method for measuring the marker residue in the target tissue in accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(H) and (i), and 706(b)(5)(B) of the act.

(Information collection requirements approved by the Office of Management and Budget under control number 0910-0228)

§ 500.90 Waiver of requirements.

In response to a petition or on the Commissioner's own initiative, the Commissioner may waive, in whole or

in part, the requirements of this subpart except those provided under § 500.88. A petition for this waiver may be filed by any person who would be adversely affected by the application of the requirements to a particular compound. The petition shall explain and document why the requirements from which a waiver is requested are not reasonably applicable to the compound, and set forth clearly the reasons why the alternative procedures will provide the basis for concluding that approval of the compound satisfies the requirements of the anticancer provisions of the act. If the Commissioner determines that waiver of any of the requirements of this subpart is appropriate, the Commissioner will state the basis for that determination in the regulation approving marketing of the sponsored compound.

(Information collection requirements approved by the Office of Management and Budget under control number 0910-0228)

§ 500.92 Implementation.

(a) This Subpart E applies to all new animal drug applications, food additive petitions, and color additive petitions concerning any compound intended for use in food-producing animals (including supplemental applications and amendments to petitions).

(b) This Subpart E also applies in the following manner to compounds already approved:

(1) For those compounds that FDA determines may induce cancer when ingested by man or animals, i.e., suspect carcinogens, §§ 500.80(b), 500.82, and 500.90 apply.

(2) For those compounds that FDA determines have been shown to induce cancer when ingested by man or animals, §§ 500.82 through 500.90 apply.

§ 501.1 Principal display panel of package form animal food.

The term "principal display panel" as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding.

Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term “"area of the principal display panel" means the area of the side or surface that bears the principal display panel, which area shall be:

(a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference;

(c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious "principal display panel" such as the top of a triangular or circular package, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

§ 501.2 Information panel of package for animal food.

(a) The term "information panel" as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions:

(1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends,

the panel immediately contiguous and to the right of this part of the label may be used.

(2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel.

(3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.

(b) All information required to appear on the label of any package of food pursuant to §§ 501.4, 501.5, 501.8 and 501.17 shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter.

(c) All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than 16 inch in height unless an exemption pursuant to paragraph (f) of this section is established. The requirements for conspicuousness and legibility shall include the specifications of §§ 501.15 and 501.105(h) (1) and (2).

(1) Packaged foods are exempt from the type size requirements of this paragraph: Provided, That:

(i) The package is designed such that it has a surface area that can bear an information panel and/or an alternate principal display panel.

(ii) The area of surface available for labeling on the principal display panel of the package as this term is defined in § 501.1 is less than 10 square inches.

(iii) The label information includes a full list of ingredients in accordance with regulations in this part.

(iv) The information required by paragraph (b) of this section appears on the principal display panel or information panel label in accordance with the provisions of this paragraph (c) except that the type size is not less than 64 inch in height.

(2) Packaged foods are exempt from the type size requirements of this paragraph: Provided, That:

(i) The package is designed such that it has a single "obvious principal

display panel" as this term is defined in § 501.1 and has no other available surface area for an information panel or alternate principal display panel.

(ii) The area of surface available for labeling on the principal display panel of the package as this term is defined in § 501.1 is less than 12 square inches and bears all labeling appearing on the package.

(iii) The label information includes a full list of ingredients in accordance with regulations in this part.

(iv) The information required by paragraph (b) of this section appears on the single, obvious principal display panel in accordance with the provisions of this paragraph (c) except that the type size is not less than 32 inch in height.

(3) Packaged foods are exempt from the type size requirements of this paragraph: Provided, That:

(i) The package is designed such that it has a total surface area available to bear labeling of less than 12 square inches.

(ii) The label information includes a full list of ingredients in accordance with regulations in this part.

(iii) The information required by paragraph (b) of this section appears on the principal display panel or information panel label in accordance with the provisions of this paragraph (c) except that the type size is not less than 32 inch in height.

(d) All information required to appear on the principal display panel or on the information panel pursuant to this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, any vignettes, design, and other nonmandatory label information shall not be considered. If there is insufficient space for all of this information to appear on a single panel, it may be divided between these two panels except that the information required pursuant to any given section or part shall all appear on the same panel. A food whose label is required to bear the ingredient statement on the principal display panel may bear all other information specified in paragraph (b) of this section on the information panel.

(e) All information appearing information panel pursuant t section shall appear in one plac out other intervening material.

(f) If the label of any pack food is too small to accommod of the information require §§ 501.4, 501.5, 501.8, and 501.1 Commissioner may establish by lation an acceptable alte method of disseminating such mation to the public, e.g., a ty smaller than one-sixteenth in height, or labeling attached to serted in the package or availa the point of purchase. A petit questing such a regulation, amendment to this paragraph s submitted pursuant to Part 10 chapter.

[41 FR 38619, Sept. 10, 1976, as ame 42 FR 4716, Jan. 25, 1977; 42 FR 156 22, 1977]

§ 501.3 Identity labeling of animal package form.

(a) The principal display pan food in package form shall bear of its principal features a staten the identity of the commodity.

(b) Such statement of identit be in terms of:

(1) The name now or hereafte fied in or required by any app Federal law or regulation; or, absence thereof,

(2) The common or usual na the food; or, in the absence ther (3) An appropriately desc term, or when the nature of th is obvious, a fanciful name com used by the public for such food

(c) Where a food is marketed ous optional forms (whole, diced, etc.), the particular form be considered to be a necessary the statement of identity and s declared in letters of a type siz ing a reasonable relation to the the letters forming the other nents of the statement of ic except that if the optional form ble through the container or is ed by an appropriate vignette, t ticular form need not be inclu the statement. This specificatic not affect the required declarat identity under definitions and

ards for foods promulgated pursuant to section 401 of the act.

(d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.

(1) A food shall be deemed to be an imitation and thus subject to the requirements of section 403(c) of the act if it is a substitute for and resembles another food but is nutritionally inferior to that food.

(2) A food that is a substitute for and resembles another food shall not be deemed to be an imitation provided it meets each of the following requirements:

(i) It is not nutritionally inferior to the food for which it substitutes and which it resembles.

(ii) Its label bears a common or usual name that complies with the provisions of § 502.5 of this chapter and that is not false or misleading, or in the absence of an existing common or usual name, an appropriately descriptive term that is not false or misleading. The label may, in addition, bear a fanciful name which is not false or misleading.

(3) A food for which a common or usual name is established by regulation (e.g., in a standard of identity pursuant to section 401 of the act, in a common or usual name regulation pursuant to false or misleading. The label may, in addition, bear a fanciful name which is Part 502 of this chapter), and which complies with all of the applicable requirements of such regulation(s), shall not be deemed to be an imitation.

(4) Nutritional inferiority includes: (i) Any reduction in the content of an essential nutrient that is present in a measurable amount.

(ii) If the Commissioner concludes that a food is a substitute for and resembles another food but is inferior to the food imitated for reasons other than those set forth in this paragraph, he may propose appropriate revisions to this regulation or he may propose a separate regulation governing the particular food.

(f) A label may be required to bear the percentage(s) of a characterizing ingredient(s) or information concerning the presence or absence of an ingredient(s) or the need to add an ingredient(s) as part of the common or usual name of the food pursuant to Part 502 of this chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977]

§ 501.4 Animal food; designation of ingredients.

(a) Ingredients required to be declared on the label of a food, including foods that comply with standards of identity that require labeling in compliance with this Part 501, except those exempted by § 501.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of

§ 501.2.

(b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that:

(1) Spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of § 501.22.

(2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternatives:

(i) By declaring the established common or usual name of the ingredient followed by a parenthetical listing