Appendix A to Part 210 - Alternate Foods for Meals
7:4.1.1.1.1.6.1.11.1 : Appendix A
Appendix A to Part 210 - Alternate Foods for Meals I. Enriched
Macaroni Products with Fortified Protein
1. Schools may utilize the enriched macaroni products with
fortified protein defined in paragraph 3 as a food item in meeting
the meal requirements of this part under the following terms and
conditions:
(a) One ounce (28.35 grams) of a dry enriched macaroni product
with fortified protein may be used to meet not more than one-half
of the meat or meat alternate requirements specified in § 210.10,
when served in combination with 1 or more ounces (28.35 grams) of
cooked meat, poultry, fish, or cheese. The size of servings of the
cooked combination may be adjusted for various age groups.
(b) Only enriched macaroni products with fortified protein that
bear a label containing substantially the following legend shall be
so utilized: “One ounce (28.35 grams) dry weight of this product
meets one-half of the meat or meat alternate requirements of lunch
or supper of the USDA child nutrition programs when served in
combination with 1 or more ounces (28.35 grams) of cooked meat,
poultry, fish, or cheese. In those States where State or local law
prohibits the wording specified, a legend acceptable to both the
State or local authorities and FNS shall be substituted.”
(c) Enriched macaroni product may not be used for infants under
1 year of age.
2. Only enriched macaroni products with fortified protein that
have been accepted by FNS for use in the USDA Child Nutrition
Programs may be labeled as provided in paragraph 1(b) of this
appendix. Manufacturers seeking acceptance of their product shall
furnish FNS a chemical analysis, the Protein
Digestibility-Corrected Amino Acid Score (PDCAAS), and such other
pertinent data as may be requested by FNS, except that prior to
November 7, 1994, manufacturers may submit protein efficiency ratio
analysis in lieu of the PDCAAS. This information is to be forwarded
to: Director, Nutrition and Technical Services Division, Food and
Nutrition Service, U.S. Department of Agriculture, 3101 Park Center
Drive, room 607, Alexandria, VA 22302. All laboratory analyses are
to be performed by independent or other laboratories acceptable to
FNS. (FNS prefers an independent laboratory.) All laboratories
shall retain the “raw” laboratory data for a period of 1 year. Such
information shall be made available to FNS upon request.
Manufacturers must notify FNS if there is a change in the protein
portion of their product after the original testing. Manufacturers
who report such a change in protein in a previously approved
product must submit protein data in accordance with the method
specified in this paragraph.
3. The product should not be designed in such a manner that
would require it to be classified as a Dietary Supplement as
described by the Food and Drug Administration (FDA) in 21 CFR part
105. To be accepted by FNS, enriched macaroni products with
fortified protein must conform to the following requirements:
(a)(1) Each of these foods is produced by drying formed units of
dough made with one or more of the milled wheat ingredients
designated in 21 CFR 139.110(a) and 139.138(a), and other
ingredients to enable the finished food to meet the protein
requirements set out in paragraph 3.(a)(2)(i) under Enriched
Macaroni Products with Fortified Protein in this appendix. Edible
protein sources, including food grade flours or meals made from
nonwheat cereals or from oilseeds, may be used. Vitamin and mineral
enrichment nutrients are added to bring the food into conformity
with the requirements of paragraph (b) under Enriched Macaroni
Products with Fortified Protein in this appendix. Safe and suitable
ingredients, as provided for in paragraph (c) under Enriched
Macaroni Products with Fortified Protein in this appendix, may be
added. The proportion of the milled wheat ingredient is larger than
the proportion of any other ingredient used.
(2) Each such finished food, when tested by the methods
described in the pertinent sections of “Official Methods of
Analysis of the AOAC International,” (formerly the Association of
Official Analytical Chemists), 15th Ed. (1990) meets the following
specifications. This publication is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
obtained from the AOAC International, 2200 Wilson Blvd., suite 400,
Arlington, VA 22201-3301. This publication may be examined at the
Food and Nutrition Service, Nutrition and Technical Services
Division, 3101 Park Center Drive, room 607, Alexandria, Virginia
22302 or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(i) The protein content (N × 6.25) is not less than 20 percent
by weight (on a 13 percent moisture basis) as determined by the
appropriate method of analysis in the AOAC manual cited in (a)(2)
under Enriched Macaroni Products with Fortified Protein in this
appendix. The protein quality is not less than 95 percent that of
casein as determined on a dry basis by the PDCAAS method as
described below:
(A) The PDCAAS shall be determined by the methods given in
sections 5.4.1, 7.2.1. and 8.0 as described in “Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on
Protein Quality Evaluation,” Rome, 1990, as published by the Food
and Agriculture Organization (FAO) of the United Nations/World
Health Organization (WHO). This report is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of
this report may be obtained from the Nutrition and Technical
Services Division, Food and Nutrition Service, 3101 Park Center
Drive, room 607, Alexandria, Virginia 22302. This report may also
be inspected at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(B) The standard used for assessing protein quality in the
PDCAAS method is the amino acid scoring pattern established by
FAO/WHO and United Nations University (UNU) in 1985 for preschool
children 2 to 5 years of age which has been adopted by the National
Academy of Sciences, Recommended Dietary Allowances (RDA),
1989.
(C) To calculate the PDCAAS for an individual food, the test
food must be analyzed for proximate analysis and amino acid
composition according to AOAC methods.
(D) The PDCAAS may be calculated using FDA's limited data base
of published true digestibility values (determined using humans and
rats). The true digestibility values contained in the WHO/FAO
report referenced in paragraph 3.(a)(2)(i)(A) under Enriched
Macaroni Products with Fortified Protein in this appendix may also
be used. If the digestibility of the protein is not available from
these sources it must be determined by a laboratory according to
methods in the FAO/WHO report (sections 7.2.1 and 8.0).
(E) The most limiting essential amino acid (that is, the amino
acid that is present at the lowest level in the test food compared
to the standard) is identified in the test food by comparing the
levels of individual amino acids in the test food with the 1985
FAO/WHO/UNU pattern of essential amino acids established as a
standard for children 2 to 5 years of age.
(F) The value of the most limiting amino acid (the ratio of the
amino acid in the test food over the amino acid value from the
pattern) is multiplied by the percent of digestibility of the
protein. The resulting number is the PDCAAS.
(G) The PDCAAS of food mixtures must be calculated from data for
the amino acid composition and digestibility of the individual
components by means of a weighted average procedure. An example for
calculating a PDCAAS for a food mixture of varying protein sources
is shown in section 8.0 of the FAO/WHO report cited in paragraph
3.(a)(2)(i)(A) under Enriched Macaroni Products with Fortified
Protein in this appendix.
(H) For the purpose of this regulation, each 100 grams of the
product (on a 13 percent moisture basis) must contain protein in
amounts which is equivalent to that provided by 20 grams of protein
with a quality of not less than 95 percent casein. The equivalent
grams of protein required per 100 grams of product (on a 13 percent
moisture basis) would be determined by the following equation:
X = grams of protein required per 100 grams of
product a = 20 grams (amount of protein if casein) b = .95 [95% × 1
(PDCAAS of casein) c = PDCAAS for protein used in formulation
(ii) The total solids content is not less than 87 percent by
weight as determined by the methods described in the “Official
Methods of Analysis of the AOAC International” cited in paragraph
(a)(2) under Enriched Macaroni Products with Fortified Protein in
this appendix.
(b)(1) Each pound of food covered by this section shall contain
5 milligrams of thiamine, 2.2 milligrams of riboflavin, 34
milligrams of niacin or niacinamide, and 16.5 milligrams of
iron.
(2) Each pound of such food may also contain 625 milligrams of
calcium.
(3) Only harmless and assimilable forms of iron and calcium may
be added. The enrichment nutrients may be added in a harmless
carrier used only in a quantity necessary to effect a uniform
distribution of the nutrients in the finished food. Reasonable
overages, within the limits of good manufacturing practice, may be
used to assure that the prescribed levels of the vitamins and
mineral(s) in paragraphs (b)(1) and (2) under Enriched Macaroni
Products with Fortified Protein in this appendix are maintained
throughout the expected shelf life of the food under customary
conditions of distribution.
(c) Ingredients that serve a useful purpose such as to fortify
the protein or facilitate production of the food are the safe and
suitable ingredients referred to in paragraph (a) under Enriched
Macaroni Products with Fortified Protein in this appendix. This
does not include color additives, artificial flavorings, artificial
sweeteners, chemical preservatives, or starches. Ingredients deemed
suitable for use by this paragraph are added in amounts that are
not in excess of those reasonably required to achieve their
intended purposes. Ingredients are deemed to be safe if they are
not food additives within the meaning of section 201(s) of the
Federal Food, Drug and Cosmetic Act, or in case they are food
additives if they are used in conformity with regulations
established pursuant to section 409 of the act.
(d)(1) The name of any food covered by this section is “Enriched
Wheat ________ Macaroni Product with Fortified Protein”, the blank
being filled in with appropriate word(s) such as “Soy” to show the
source of any flours or meals used that were made from non-wheat
cereals or from oilseeds. In lieu of the words “Macaroni Product”
the words “Macaroni”, “Spaghetti”, or “Vermicelli” as appropriate,
may be used if the units conform in shape and size to the
requirements of 21 CFR 139.110 (b), (c), or (d).
(2) When any ingredient not designated in the part of the name
prescribed in paragraph (d)(1) under Enriched Macaroni Products
with Fortified Protein in this appendix, is added in such
proportion as to contribute 10 percent or more of the quantity of
protein contained in the finished food, the name shall include the
statement “Made with ________”, the blank being filled in with the
name of each such ingredient, e.g. “Made with nonfat milk”.
(3) When, in conformity with paragraph (d)(1) or (d)(2) under
Enriched Macaroni Products with Fortified Protein in this appendix,
two or more ingredients are listed in the name, their designations
shall be arranged in descending order of predominance by
weight.
(4) If a food is made to comply with a section of 21 CFR part
139, but also meets the compositional requirements of the Enriched
Macaroni with Fortified Protein Appendix, it may alternatively bear
the name set out in the other section.
(e) Each ingredient used shall declare its common name as
required by the applicable section of 21 CFR part 101. In addition,
the ingredients statement shall appear in letters not less than one
half the size of that required by 21 CFR 101.105 for the
declaration of net quantity of contents, and in no case less than
one-sixteenth of an inch in height.
II. Alternate Protein Products A. What Are the Criteria for
Alternate Protein Products Used in the National School Lunch
Program?
1. An alternate protein product used in meals planned under the
food-based menu planning approaches in § 210.10(k), must meet all
of the criteria in this section.
2. An alternate protein product whether used alone or in
combination with meat or other meat alternates must meet the
following criteria:
a. The alternate protein product must be processed so that some
portion of the non-protein constituents of the food is removed.
These alternate protein products must be safe and suitable edible
products produced from plant or animal sources.
b. The biological quality of the protein in the alternate
protein product must be at least 80 percent that of casein,
determined by performing a Protein Digestibility Corrected Amino
Acid Score (PDCAAS).
c. The alternate protein product must contain at least 18
percent protein by weight when fully hydrated or formulated. (“When
hydrated or formulated” refers to a dry alternate protein product
and the amount of water, fat, oil, colors, flavors or any other
substances which have been added).
d. Manufacturers supplying an alternate protein product to
participating schools or institutions must provide documentation
that the product meets the criteria in paragraphs A2. a through c
of this appendix.
e. Manufacturers should provide information on the percent
protein contained in the dry alternate protein product and on an as
prepared basis.
f. For an alternate protein product mix, manufacturers should
provide information on:
(1) the amount by weight of dry alternate protein product in the
package;
(2) hydration instructions; and
(3) instructions on how to combine the mix with meat or other
meat alternates.
B. How Are Alternate Protein Products Used in the National School
Lunch Program?
1. Schools, institutions, and service institutions may use
alternate protein products to fulfill all or part of the meat/meat
alternate component discussed in § 210.10.
2. The following terms and conditions apply:
a. The alternate protein product may be used alone or in
combination with other food ingredients. Examples of combination
items are beef patties, beef crumbles, pizza topping, meat loaf,
meat sauce, taco filling, burritos, and tuna salad.
b. Alternate protein products may be used in the dry form
(nonhydrated), partially hydrated or fully hydrated form. The
moisture content of the fully hydrated alternate protein product
(if prepared from a dry concentrated form) must be such that the
mixture will have a minimum of 18 percent protein by weight or
equivalent amount for the dry or partially hydrated form (based on
the level that would be provided if the product were fully
hydrated).
C. How Are Commercially Prepared Products Used in the National
School Lunch Program?
Schools, institutions, and service institutions may use a
commercially prepared meat or meat alternate product combined with
alternate protein products or use a commercially prepared product
that contains only alternate protein products.
[51 FR 34874, Sept. 30, 1986; 51 FR 41295, Nov. 14, 1986, as
amended at 53 FR 29164, Aug. 2, 1988; 59 FR 51086, Oct. 7, 1994; 60
FR 31216; June 13, 1995; 61 FR 37671, July 19, 1996; 65 FR 12434,
Mar. 9, 2000; 65 FR 26912, May 9, 2000; 69 FR 18803, Apr. 9, 2004]