(ix) The suggested Reference Amount (the amount of edible portion of food as consumed, excluding bone, skin or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested Reference Amount. In determining the Reference Amount, general principles and factors in paragraph (a) of this section should be followed. (x) The suggested Reference Amount shall be expressed in metric units. Reference Amounts for foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density such as mixed dishes measurable with a cup. (A) In expressing the Reference Amount in grams, the following general rules shall be followed: (1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment. (2) For quantities less than 10 grams, exact gram weights shall be used. (B) [Reserved] (xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information: (A) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the Reference Amount for the parent category to warrant a separate Reference Amount. Data must include sample size, and the mean, standard deviation, median, and modal consumed amount per eating occasion for the product identified in the labeling application and for other products in the category. All data must be derived from the same survey data. (B) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the product identified in the labeling application from the rest of the products in the category. (xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed. (A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended. (B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts. (C) The study protocol should identify potential biases and describe how potential bi ases are controlled for or, if not possible to control, how they affect interpretation of results. (D) The methodology used to collect or process data including study design, sampling procedures, materials used (e.g., questionnaire, interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse, should be fully documented. (xiii) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule. Yours very truly, Applicant By (Indicate authority) (8) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application. (9) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator. (10) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed Reference Amount and/or Product Category is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category. (i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice. (ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. (11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the FEDERAL REGISTER a proposed rule to amend the regulations to authorize the use of the Reference Amount and/or Product Category. The proposal shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's proposed rule shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the proposed Reference Amount and/or Product Category. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the proposed Reference Amount and/or Product Category shall be approved for use on the labeling of meat food products. (i) If the Reference Amount and/or Product Category is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the Reference Amount and/or Product Category on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written state ment by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category. (A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of an answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the ceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice. pro (B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. (ii) If the Reference Amount and/or Product Category is approved, the Agency shall notify the applicant, in writing, and shall also publish in the FEDERAL REGISTER a final rule amending the regulations to authorize the use of the Reference Amount and/or Product Category. (Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088) [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 1995] §317.313 Nutrient content claims; general principles. (a) This section applies to meat or meat food products that are intended for human consumption and that are offered for sale. (b) A claim which, expressly or by implication, characterizes the level of a nutrient (nutrient content claim) of the type required in nutrition labeling pursuant to §317.309, may not be made on a label or in labeling of that product unless the claim is made in accordance with the applicable provisions in this subpart. (1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the product, e.g., "low sodium" or "contains 100 calories." (2) An implied nutrient content claim is any claim that: (i) Describes the product or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., "high in oat bran"); or (ii) Suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., "healthy, contains 3 grams (g) of fat”). (3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on products intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in subpart B of this part. (4) Reasonable variations in the spelling of the terms defined in applicable provisions in this subpart and their synonyms are permitted provided these variations are not misleading (e.g., "hi" or "lo"). (c) Information that is required or permitted by §317.309 to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims. (d) A "substitute" product is one that may be used interchangeably with another product that it resembles, i.e., that it is organoleptically, physically, and functionally (including shelf life) similar to, and that it is not nutrition ally inferior to unless it is labeled as an "imitation." (1) If there is a difference in performance characteristics that materially limits the use of the product, the product may still be considered a substitute if the label includes a disclaimer adjacent to the most prominent claim as defined in paragraph (j)(2)(iii) of this section, informing the consumer of such difference (e.g., "not recommended for frying"). (2) This disclaimer shall be in easily legible print or type and in a size no less than that required by §317.2(h) for the net quantity of contents statement, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclaimer statement shall be no less than one-half the size of the claim but no smaller than 16-inch minimum height, except as permitted by §317.400(d)(2). (e)(1) Because the use of a "free" or "low" claim before the name of a product implies that the product differs from other products of the same type by virtue of its having a lower amount of the nutrient, only products that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the product, remove the nutrient from the product, or not include the nutrient in the product, may bear such a claim (e.g., "low sodium beef noodle soup"). (2) Any claim for the absence of a nutrient in a product, or that a product is low in a nutrient when the product has not been specially processed, altered, formulated, or reformulated to qualify for that claim shall indicate that the product inherently meets the criteria and shall clearly refer to all products of that type and not merely to the particular brand to which the labeling attaches (e.g., "lard, a sodium free food"). (f) A nutrient content claim shall be in type size and style no larger than two times that of the statement of identity and shall not be unduly prominent in type style compared to the statement of identity. (g) Labeling information required in §§ 317.313, 317.354, 317.356, 317.360, 317.361, 317.362, and 317.380, whose type size is stunning or ge etric cent og of swine, the goats with the end. and the hunt I with, in comme ins contained in the by designated a methods of simps ing of such mad on of electric carrer. dling. (D) The elect administered soa nimum, surgical ane te where the ensation The A unned or killed beton led, hoisted throw y shall be expose & place of application U shall be done with a driving animals to the $317.313 ss it is labeled as erence in perform that materially product, the prod dered a substitute i disclaimer adia minent claim A pebain of this he consumer of . 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