[Federal Register Volume 59, Number 194 (Friday, October 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24902]


[[Page Unknown]]

[Federal Register: October 7, 1994]


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DEPARTMENT OF AGRICULTURE
Food and Nutrition Service

7 CFR Part 210

 

Alternate Foods for Meals: Enriched Macaroni Products With 
Fortified Protein; National School Lunch Program

AGENCY: Food and Nutrition Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule requires the use of the Protein Digestibility- 
Corrected Amino Acid Score (PDCAAS) instead of the Protein Efficiency 
Ratio (PER) for evaluating the biological quality of proteins in 
enriched macaroni products with fortified protein. This action is 
necessary for consistency with the Food and Drug Administration's (FDA) 
Nutrition Labeling Education Act regulations. The PDCAAS is a more 
accurate, efficient and less costly method for measuring protein 
quality of this food product used in the National School Lunch Program 
(NSLP). This rule also makes clear that enriched macaroni products may 
not be used for infants under one year of age. In addition, this rule 
deletes reference in the NSLP regulations to the FDA Standard of 
Identity (21 CFR 139.117) for enriched macaroni products with fortified 
protein which has been stayed by FDA and clarifies that protein quality 
is to be determined on the dry basis not on the cooked food. This rule 
also makes a typographical correction and in accordance with the Metric 
Conversion Act of 1975 adds the metric equivalent for all weights and 
measurements. This final rule further clarifies that manufacturers of 
enriched macaroni with fortified protein must notify the Food and 
Nutrition Service (FNS) if there is a change in the protein content of 
their product after the original testing. FNS will assume the protein 
content of the product remains the same as that submitted for the 
original testing unless otherwise notified.

DATES: This final rule is effective on October 7, 1994. The 
incorporation by reference of the ``Official Methods of Analysis of the 
AOAC International'' (formerly the Association of Analytical Chemists) 
15th Ed. (1990) and the ``Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation,'' as published by the Food 
and Agriculture Organization of the United Nations/World Health 
Organization, listed in this regulation is approved by the Director of 
the Federal Register as of October 7, 1994.

FOR FURTHER INFORMATION CONTACT: Ms. Marion Hinners, Section Head, Food 
Science and Nutrition Section, Nutrition and Technical Services 
Division, USDA, (703) 305-2556.

SUPPLEMENTARY INFORMATION: This rule has been determined to be not 
significant for purposes of Executive Order 12866 and, therefore, has 
not been reviewed by the Office of Management and Budget.
    This rule has been reviewed with regard to the requirements of the 
Regulatory Flexibility Act (5 U.S.C. 601 through 612). The 
Administrator of FNS has certified that this rule will not have a 
significant economic impact on a substantial number of small entities. 
There are currently fewer than ten companies participating in the Child 
Nutrition Programs (CNPs) under this regulation. In addition, the 
changes contained in this regulation are expected to reduce costs for 
the manufacturer.
    The Administrator of FNS has determined pursuant to 5 U.S.C. 553 
(b) and (d) that notice and comment on this rule prior to 
implementation is unnecessary and contrary to public interest. The 
public interest would be better served by allowing a more accurate and 
efficient method for measuring the protein quality of foods used in the 
NSLP. This change will allow food companies to minimize costs, thereby 
allowing them to provide quality products at the lowest cost possible. 
Moreover, receiving prior comment would be unnecessary and 
impracticable in this case for the following reasons. First, requiring 
prior notice and comment would waste valuable government resources. The 
Food Safety and Inspection Service of the Department of Agriculture 
(USDA) and FDA already have received and reviewed comments on this 
issue in response to proposed rules governing nutrition labeling of all 
regulated products, including products covered by this FNS regulation, 
and have published final regulations which accept the PDCAAS method. 
Second, FNS, with FDA concurrence, has already recognized the merits of 
the PDCAAS method in permitting its use for vegetable protein products 
(VPPs). Third, this rule provides affected parties an implementation 
period of 30 days during which either protein quality test may be used 
for enriched macaroni products.

Executive Order 12778

    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. This rule is intended to have preemptive effect 
with respect to any State or local laws, regulations or policies which 
conflict with its provisions or which would otherwise impede its full 
implementation. This rule is not intended to have retroactive effect 
unless so specified in the ``Date'' section of this preamble. Prior to 
any judicial challenge to the provisions of this rule or the 
application of the provisions, all applicable administrative procedures 
must be exhausted. In the NSLP, the administrative procedures are set 
forth under the following regulations: (1) school food authority 
appeals of State agency findings as a result of a Coordinated Review 
must follow State agency hearing procedures as established pursuant to 
7 CFR 210.18(q); (2) school food authority appeals of FNS findings as a 
result of a Coordinated Review must follow FNS hearing procedures as 
established pursuant to 7 CFR 210.30(d)(3); AND (3) State agency 
appeals of State Administrative Expense fund sanctions (7 CFR 
235.11(b)) must follow the FNS Administrative Review Process as 
established pursuant to 7 CFR 235.11(f).
    The NSLP is listed in the Catalog of Federal Domestic Assistance 
under No. 10.555 and is subject to the provisions of Executive Order 
12372 which requires intergovernmental consultation with State and 
local officials. (7 CFR Part 3015, Subpart V and final rule-related 
notice at 48 FR 29114, June 24, 1983).
    No new data collection or recordkeeping requiring Office of 
Management and Budget (OMB) approval under the Paperwork Reduction Act 
of 1980 (44 U.S.C. 3501 through 3502) are included in this rule.
    Background: On March 27, 1974, the Department published final 
regulations (39 FR 11248) which defined enriched macaroni products with 
fortified protein as a food item meeting the NSLP meal pattern 
requirements specified in 7 CFR 210.10 under specified terms and 
conditions. At that time, the PER was the only recognized test for 
determining the biological quality of protein in foods. At present, 
there is another recognized method for determining the biological 
quality of protein in foods, the PDCAAS method. Several international 
bodies, including a Joint Expert Consultation on Protein Evaluation of 
the Food and Agriculture Organization (FAO) of the United Nations and 
the World Health Organization (WHO) (1989), have concluded that PDCAAS, 
in which a score of 1.0 equals 100 percent of the 1985 WHO essential 
amino acid requirement patterns for 2 to 5 year olds, is an appropriate 
method for evaluating food protein quality. The 2 to 5 year old 
requirement is the most inclusive of those recommended and thus may be 
used for all age groups, except infants.
    PER is based on the assumption that proteins which are equivalent 
to casein meet the amino acid and protein requirements for the various 
age groups consuming a particular food. The specification of this 
methodology, which is based upon rodent nutrition requirements, was 
assumed to correlate to human requirements when PER was adopted as the 
sole regulatory method for determining protein quality. Extensive 
studies have since been conducted on human amino acid requirements 
which demonstrate that the essential amino acid requirements of humans 
are significantly different from those of rodents. This was recognized 
as early as 1980 by a conference of protein scientists and 
nutritionists held to assess protein quality in humans. A report of 
this working conference indicated a dissatisfaction with the PER 
method. The report further recognized that an amino acid scoring 
system, corrected for digestibility, is an appropriate alternative for 
measuring protein value.
    In 1985, WHO published its revised Energy and Protein Requirement 
Report prepared by a Joint Expert Consultation of the FAO/WHO and 
United Nations University (UNU). This consultation revised amino acid 
pattern requirements for humans into age groups of 2 to 5 years, 6 to 
12 years, and adult, and extensively reviewed the requirements based on 
amino acid scoring and digestibility. Of the three amino acid patterns 
established, the 2 to 5 year old child pattern has the highest 
individual and total requirements. The report stated that protein and 
diets containing essential amino acids that met the greater needs of 
young children were also adequate for older children and adults, 
whereas the reverse may not be true. On this basis, the Joint FAO/WHO 
Expert Consultation on Protein Evaluation (1989) concluded that no 
adequate basis existed for using different scoring patterns for 
different age groups, with the exception of infants, who have a much 
greater need for essential amino acids. They recommended that the FAO/
WHO/UNU amino acid scoring pattern for preschool children should be 
used to evaluate protein quality for all age groups, except infants. 
PDCAAS was recommended for calculating dietary protein intakes. Thus, 
precise human amino acid requirement patterns are available for all age 
groups.
    Both FNS and the FDA have recognized the applicability and 
usefulness of the PDCAAS method of measuring protein quality. The 
regulation governing the use of VPP in the Child Nutrition Programs, 7 
CFR Parts 210, 225 and 226, Appendix A - Alternate Foods for Meals; 
Vegetable Protein Products, published January 7, 1983, allowed FNS to 
approve an alternate test for measuring the biological quality of 
protein for VPP. This provision was included in the regulation in 
anticipation of recognition by the scientific community and FDA of the 
PDCAAS. FNS has since accepted the PDCAAS method in addition to the PER 
method for determining protein quality of VPP. This acceptance was 
based on the Joint FAO/WHO Expert Consultation on Protein Evaluation 
(1989) and with FDA's concurrence.
    On July 19, 1990 (55 FR 29487 at 29499), FDA stated that their 
regulatory requirements to use PER ``inhibit(ed) flexibility in 
determining protein quality by alternative methodologies.'' At that 
time, FDA proposed to continue the use of the PER, while also allowing 
use of alternative acceptable validated procedures as they become 
available.
    Subsequently, in response to a petition from Protein Technologies 
International, Inc., FDA stated in the preamble to the nutrition 
labeling proposal published on November 27, 1991 (56 FR 60366 at 
60369), that permitting PDCAAS to be used as an alternative to PER had 
merit. In commenting on that petition FDA quoted its earlier comments 
on the need for a flexible approach to determining protein quality:

    As new methodologies and new information on amino acid 
requirements of various age groups become available, the agency 
believes it must become more flexible in regard to permitted protein 
quality methodologies. Therefore, while the PER method described in 
the Official Methods of Analysis of the Association of Official 
Analytical Chemists may continue to be used as one of the methods 
for assessing the protein quality of foods, alternative acceptable 
validated procedures may be used as they become available. (55 FR 
29487 at 29499).

    However, FDA later proposed to require the PDCAAS, stating in the 
preamble (56 FR 60366 at 60370) that:

    The agency has reviewed the FAO/WHO report and tentatively 
accepts its conclusion that the protein digestibility-corrected 
amino acid score method is more appropriate for assessing protein 
quality of foods than animal assays and is preferable for regulatory 
purposes.

    In October, 1989, the Subcommittee on the 10th Edition of the 
Recommended Dietary Allowances published the revised Recommended 
Dietary Allowances. These new allowances confirm and accept the amino 
acid requirement pattern as published by the WHO, 1985, and recognize 
PDCAAS as an appropriate method of assessing protein quality of human 
diets. The amino acid requirements for the 2 to 5 year old suggested by 
both of these scientific bodies are identical. The Codex Alimentarius 
Vegetable Protein Committee as well as the Codex Committee on Special 
Dietary Foods have also recommended amino acid scoring for evaluation 
of vegetable proteins and special dietary foods.
    The PDCAAS was considered and accepted by the Joint FAO/WHO Codex 
Alimentarius Commission which convened in Geneva, Switzerland during 
July 1989. An Expert Consultation convened at the request of the Codex 
Alimentarius Commission reviewed the amino acid scoring methodologies 
and recommended the implementation of the PDCAAS for measuring protein 
quality. After extensive deliberation, resulting in a comprehensive 
report, it was reported that, ``. . . the Consultation agreed that the 
Protein Digestibility-Corrected Amino Acid Score method was the most 
suitable approach for routine evaluation of protein quality for humans, 
and recommended the adoption of this method as an official method at 
the international level.'' (Joint FAO/WHO Expert Consultation on 
Protein Evaluation, Codex Alimentarius, Washington, D.C., 1989). The 
Expert Consultation's report and recommendations were transmitted to 
the FAO Secretariat in Rome for final review and dissemination to the 
Codex Alimentarius Commission membership. The report of the Expert 
Consultation contains many findings and conclusions, most supportive of 
the PDCAAS. No conclusions adverse to this method were reported.
    On January 6, 1993, FDA published final rules (58 FR 2079) 
requiring use of the PDCAAS method as the method for determining 
protein quality for food intended for children over 1 year of age and 
adults. While this method is recommended for all children above 1 year 
of age, it is not recommended for infants, and therefore FDA's final 
rule (58 FR 2079 at 2102) retained the PER method for assessing protein 
quality and retained casein as the standard in expressing the 
percentage of the Reference Daily Intake (RDI) for protein in foods 
represented and purported to be for use by infants. This rule became 
effective on May 8, 1994. In recognition of these scientific advances 
and the adoption by FDA of PDCAAS as the only method for determining 
protein quality for children above one year of age, this rule amends 
the NSLP regulations at appendix A of Part 210 to require PDCAAS as the 
only method for determining protein quality for enriched macaroni. 
However, in order to provide affected parties an implementation period, 
the amended paragraph 2 further provides that for 30 days after 
publication of the rule either the PER or the PDCAAS may be used.
    Finally, a new paragraph 1(c) is added to Appendix A to make clear 
that enriched macaroni may not be used for infants under 1 year of age 
in the NSLP. Accordingly, FNS will no longer approve enriched macaroni 
products purported for use by infants regardless of what method their 
protein quality has been tested. It was never the Department's 
intention that enriched macaroni products be served to infants and this 
amendment is meant to make clear that policy.
    Manufacturers of enriched macaroni with fortified protein, 
currently approved by FNS, will not be affected by the change to an 
alternate method unless the nutritional composition of their approved 
product changes. Should the nutritional composition of an approved 
product previously tested under PER method change after the 30 day 
implementation period, data obtained by the PDCAAS method will be 
required for re-approval.
    The FDA Standard of Identity (21 CFR 139.117), referenced and 
quoted in Appendix A and upon which the FNS final regulation was based, 
was stayed on March 21, 1978, pending a determination of whether a 
public hearing was necessary to resolve issues raised by objections (43 
FR 11695). At that time, FDA stated that ``during the period of the 
stay, the (enriched macaroni products with fortified protein) may be 
introduced into interstate commerce with appropriate labeling as a 
nonstandardized food.'' (43 FR 11695). Therefore, this rule deletes all 
references to that Standard in Appendix A. However, the requirements 
for processing and labeling of enriched macaroni products with 
fortified protein prescribed by FDA in the stayed Standard of Identity 
were previously incorporated in the FNS final rule and will remain the 
same, with some technical changes.
    In addition, this final rule amends the current regulation to 
correct a statement which has caused confusion and which was recently 
brought to our attention by analytical laboratories. The current 
regulation states that the protein quality is to be determined on the 
cooked food. However, determining protein quality on the cooked food is 
not feasible in practice, because when utilizing the PER method the 
moisture content prevents laboratory rodents from eating test foods in 
sufficient quantities to accurately determine protein quality. 
Likewise, the moisture content in the cooked food may affect the test 
results under the PDCAAS method. Therefore, FAO/WHO suggests a moisture 
content in the cooked food of less than ten percent for viable testing. 
Determinations made on a dry basis has been the procedure commonly 
employed by commercial laboratories in the past. Thus, this rule 
requires determination of protein quality on a dry basis.
    This final rule makes a typographical correction and, in accordance 
with the Metric Conversion Act of 1975, adds, side by side, the metric 
equivalent for all weights and measurements contained in the rule.
    This final rule also includes a clarification that all 
manufacturers, including those with currently accepted macaroni 
products, must notify FNS if there is a change in the protein portion 
of their product since the original data submission and product 
approval. FNS will assume the protein content remains the same unless 
otherwise notified.

List of Subjects in 7 CFR Part 210

    Children, Commodity school program, Food assistance programs, 
Grants programs--Social programs, Incorporation by reference, National 
School Lunch Program, Nutrition, Reporting and recordkeeping 
requirements, Surplus agricultural commodities.

    Accordingly, 7 CFR part 210 is amended as follows:

PART 210--NATIONAL SCHOOL LUNCH PROGRAM

    1. The authority citation for 7 CFR part 210 continues to read as 
follows:

    Authority: 42 U.S.C. 1751-1760, 1779.

    2. In Appendix A--Alternate Foods for Meals; Enriched Macaroni 
Products with Fortified Protein:
    (a) The heading of Appendix A is revised.
    (b) A new subheading is added under the heading of Appendix A.
    (c) Paragraphs 1(a) and 1(b) are amended by adding ``(28.35 
grams)'' after the words ``ounce'' or ``ounces'' wherever they appear.
    (d) A new paragraph 1(c) is added.
    (e) Paragraphs 2 and 3 are revised.

Appendix A to Part 210--Alternate Foods for Meals Enriched Macaroni 
Products With Fortified Protein

    1. * * *
    (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 the Office of the Federal Register, 800 North Capital 
Street, NW., suite 700, Washington, DC.
    (i) The protein content (N x 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 Office of the Federal Register 800 North Capitol St., NW., 
suite 700, Washington, DC.
    (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:

TR07OC94.022

    X=grams of protein required per 100 grams of product
    a=20 grams (amount of protein if casein)
    b=.95 [95%  x  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 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 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.
* * * * *
    Dated: September 22, 1994.
Ellen Haas,
Assistant Secretary for Food and Consumer Services.
[FR Doc. 94-24902 Filed 10-6-94; 8:45 am]
Billing Code 3410-30-U