[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.312]
[Page 197-203]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
Subpart B--Nutrition Labeling
Sec. 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
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(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\
------------------------------------------------------------------------
Reference
Product category 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
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the Reference
Amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve). If not listed separately, the
Reference Amount for the unprepared form (e.g., dehydrated cereal) is
the amount required to make one Reference Amount of the prepared form.
\3\ Manufacturers are required to convert the Reference Amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures established by regulation.
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply \1,2,3,4,5\
------------------------------------------------------------------------
Reference amount Reference amount
Product category ----------------------------------------
Ready-to-serve Ready-to-cook
------------------------------------------------------------------------
Egg mixtures, (western style 110 g n/a.
omelet, souffle, egg foo young
.
Lard, margarine, shortening.... 1 tbsp n/a.
Salad and potato toppers; e.g., 7 g n/a.
bacon bits.
Bacon (bacon, beef breakfast 15 g 54 g=bacon. 30 g =
strips, pork breakfast strips, breakfast strips.
pork rinds).
Dried; e.g., jerky, dried beef, 30 g n/a.
Parma ham sausage products
with a moisture/protein ratio
of less than 2:1; e.g.,
pepperoni.
Snacks; e.g., meat snack food 30 g n/a.
sticks.
Luncheon meat, bologna, 55 g n/a.
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.
Linked meat sausage products, 55 g n/a. 75 g=uncooked
Vienna sausage, frankfurters, sausage.
pork sausage, imitation
frankfurters, bratwurst,
kielbasa, Polish sausage,
summer sausage, mettwurst,
smoked country sausage, smoked
sausage, smoked or pickled
meat, pickled pigs feet.
Entrees without sauce, cuts of 85 g 114 g.
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.
Canned meats, canned beef, 55 g n/a.
canned pork. \4\.
Entrees with sauce, barbecued 140 g n/a.
meats in sauce.
Mixed dishes NOT measurable 140 g (plus 55 g n/a.
with a cup; \5\ e.g., burrito, for products with
egg roll, enchilada, pizza, sauce toppings)
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.
Mixed dishes measurable with a 1 cup n/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.
Salads--pasta or potato, potato 140 g n/a.
salad with bacon, macaroni and
meat salad.
Salads--all other meat, salads, 100 g n/a.
ham salad.
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Soups--all varieties........... 245 g n/a.
Major main entree type sauce; 125 g n/a.
e.g., spaghetti sauce with
meat, spaghetti sauce with
meatballs.
Minor main entree sauce; e.g., \1/4\ cup n/a.
pizza sauce with meat, gravy.
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 125 g n/a.
sauce.
Soup....................... 245 g n/a.
Entree measurable with a 1 cup n/a.
cup.
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-78 and the
1987-88 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Manufacturers are required to convert the Reference Amounts to the
label serving size in a household measure most appropriate to their
specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or
exclusive. Examples are provided to assist manufacturers in
identifying appropriate product Reference Amount.
\4\ If packed or canned in liquid, the Reference Amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed.
\5\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(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 Sec. 317.313(d), such
[[Page 200]]
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:
________________________________________________________________________
(Date)
The undersigned, ------------ submits this labeling application
pursuant to 9 CFR 317.312 with respect to Reference Amount and/or
Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy, and
constituting a part of this labeling application, are the following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label,
using the format established by regulation;
(iv) A description of the form in which the product will be
marketed;
(v) The intended dietary uses of the product with the major use
identified (e.g., ham as a luncheon meat);
(vi) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used
[[Page 201]]
as an ingredient with information on the prioritization of the use;
(vii) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(viii) The names of the most closely-related products (or in the
case of foods for special dietary use and imitation or substitute foods,
the names of the products for which they are offered as substitutes);
(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 biases 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
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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 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.
(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 proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(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
[[Page 203]]
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]