9 C.F.R. § 317.312

Reference amounts customarily consumed per eating occasion.

(a) The general principles followed in arriving at the reference amounts customarily consumed per eating occasion (Reference Amount(s)), as set forth in paragraph (b) of this section, are:

(1) The Reference Amounts are calculated for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These Reference Amounts are based on data set forth in appropriate national food consumption surveys.

(2) The Reference Amounts are calculated for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. Such Reference Amounts are to be used only when the product is specially formulated or processed for use by an infant or by a child under 4 years of age.

(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.

(4) To determine the amount of food customarily consumed per eating occasion, the mean, median, and mode of the consumed amount per eating occasion were considered.

(5) When survey data were insufficient, FSIS took various other sources of information on serving sizes of food into consideration. These other sources of information included:

(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;

(ii) Serving sizes recommended in comments;

(iii) Serving sizes used by manufacturers and grocers; and

(iv) Serving sizes used by other countries.

(6) Because they reflect the amount customarily consumed, the Reference Amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.

(7) The Reference Amount is based on the major intended use of the product (e.g., a mixed dish measurable with a cup as a main dish and not as a side dish).

(8) The Reference Amounts for products that are consumed as an ingredient of other products, but that may also be consumed in the form in which they are purchased (e.g., ground beef), are based on use in the form purchased.

(9) FSIS sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform Reference Amount.

(b) The following Product Categories and Reference Amounts shall be used as the basis for determining serving sizes for specific products:

Table 1—Reference Amounts Customarily Consumed per Eating Occasion—Infant and Toddler Foods 1 2 3; Product category | Reference amount; Infant & Toddler Foods:; Dinner Dry Mix | 15 g; Dinner, ready-to-serve, strained type | 60 g; Dinner, soups, ready-to-serve junior type | 110 g; Dinner, stew or soup ready-to-serve toddlers | 170 g; Plain meats and meat sticks, ready-to-serve | 55 g

Table 2—Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply 1 2 3 4 5; Product category | Reference amount | Ready-to-serve | Reference amount | Ready-to-cook; Egg mixtures, (western style omelet, souffle, egg foo young | 110 g | n/a.; Lard, margarine, shortening | 1 tbsp | n/a.; Salad and potato toppers; e.g., bacon bits | 7 g | n/a.; Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) | 15 g | 54 g = bacon. 30 g = breakfast strips.; Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio of less than 2:1; e.g., pepperoni | 30 g | n/a.; Snacks; e.g., meat snack food sticks | 30 g | n/a.; Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crumbles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings | 55 g | n/a.; Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet | 55 g | n/a. 75 g = uncooked sausage.; Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pureed adult foods | 85 g | 114 g.; Canned meats, canned beef, canned pork. 4 | 55 g | n/a.; Entrees with sauce, barbecued meats in sauce | 140 g | n/a.; Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada | 140 g (plus 55 g for products with sauce toppings) | n/a.; Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta | 1 cup | n/a.; Salads—pasta or potato, potato salad with bacon, macaroni and meat salad | 140 g | n/a.; Salads—all other meat, salads, ham salad | 100 g | n/a.; Soups—all varieties | 245 g | n/a.; Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with meatballs | 125 g | n/a.; Minor main entree sauce; e.g., pizza sauce with meat, gravy | 1/4 cup | n/a.; Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat.; As reconstituted:; Amount to make one Reference Amount of the final dish; e.g.,; Gravy | 1/4 cup | n/a.; Major main entree type sauce | 125 g | n/a.; Soup | 245 g | n/a.; Entree measurable with a cup | 1 cup | n/a.

(c) For products that have no Reference Amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., lunch meat with cheese and crackers), the Reference Amount for the combined product shall be determined using the following rules:

(1) For bulk products, the Reference Amount for the combined product shall be the Reference Amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients.

(2) For products where the ingredient represented as the main ingredient is one or more discrete units, the Reference Amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the Reference Amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients.

(3) If the Reference Amounts are in compatible units, they shall be summed (e.g., ingredients in equal volumes such as tablespoons). If the Reference Amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., grams of one ingredient plus gram weight of tablespoons of a second ingredient).

(d) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a Reference Amount for the product in the prepared form, then the Reference Amount for the unprepared product shall be determined using the following rules:

(1) Except as provided for in paragraph (d)(2) of this section, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the Reference Amount for the prepared product as established in paragraph (b) of this section.

(2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the Reference Amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the Reference Amount for the prepared product as established in paragraph (b) of this section.

(e) The Reference Amount for an imitation or substitute product or altered product as defined in § 317.313(d), such as a “low calorie” version, shall be the same as for the product for which it is offered as a substitute.

(f) The Reference Amounts set forth in paragraphs (b) through (e) of this section shall be used in determining whether a product meets the criteria for nutritional claims. If the serving size declared on the product label differs from the Reference Amount, and the product meets the criteria for the claim only on the basis of the Reference Amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the Reference Amount as it appears in paragraph (b) of this section followed, in parentheses, by the amount in common household measure if the Reference Amount is expressed in measures other than common household measures.

(g) The Administrator, on his or her own initiative or on behalf of any interested person who has submitted a labeling application, may issue a proposal to establish or amend a Product Category or Reference Amount identified in paragraph (b) of this section.

(1) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.

(2) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(3) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.

(4) Data accompanying the labeling application, such as food consumption data, shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.

(5) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.

(6) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.

(7) Labeling applications for a new Reference Amount and/or Product Category shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC 20250:

[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]