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

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