[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12156-12159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5293]



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DEPARTMENT OF AGRICULTURE
7 CFR Part 58

[DA-93-03]


Grading and Inspection, General Specifications for Approved 
Plants and Standards for Grades of Dairy Products; United States 
Standards for Grades of Nonfat Dry Milk (Spray Process)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This document proposes to revise the United States Standards 
for Grades of Nonfat Dry Milk (Spray Process). The proposed changes 
would reduce existing bacterial standard plate count maximums and 
incorporate a coliform requirement to reflect the ability of the U.S. 
dairy industry to produce high-quality nonfat dry milk. The reduction 
in the maximum standard plate count is made possible through improved 
raw milk quality and enhanced processing and sanitation techniques. The 
inclusion of a maximum coliform count adds to the assurance that post-
pasteurization contamination has not occurred. This proposal was 
developed in cooperation with the American Dairy Products Institute and 
other trade associations.

DATES: Comments should be filed by May 5, 1995.

ADDRESSES: Comments should be sent to: Director, Dairy Division, 
Agricultural Marketing Service, U.S. Department of Agriculture, Room 
2968-S, P.O. Box 96456, Washington, DC 20090-6456. They will be 
available for public inspection at the Dairy Division in Room 2750-S 
during regular business hours.

FOR FURTHER INFORMATION CONTACT: Roland S. Golden, Dairy Products 
Marketing Specialist, Dairy Standardization Branch, USDA/AMS/Dairy 
Division, Room 2750-S, P.O. Box 96456, Washington, DC 20090-6456, (202) 
720-7473.

SUPPLEMENTARY INFORMATION: This proposed rule has been reviewed under 
Executive Order 12778, Civil Justice Reform. This action is not 
intended to have retroactive effect. This rule would not preempt any 
State or local laws, regulations, or policies, unless they present an 
irreconcilable conflict with this rule. There are no administrative 
procedures which must be exhausted prior to any judicial challenge to 
the provisions of this rule.
    The proposed rule also has been reviewed in accordance with the 
Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The Administrator, 
Agricultural Marketing Service, has determined that the proposed rule, 
if promulgated, would not have a significant economic impact on a 
substantial number of small entities because use of the standards is 
voluntary and the revisions would not increase costs to those utilizing 
the standards.
    The Department is issuing this rule in conformance with Executive 
Order 12866.
    To provide quality grade standards that reflect the ability of the 
U.S. dairy industry to produce high-quality nonfat dry milk, USDA is 
proposing the following changes in the U.S. Standards for Grades of 
Nonfat Dry Milk (Spray Process). [[Page 12157]] 

1. Expand the U.S. Grade Standards To Include a Maximum Coliform Count 
in USDA-Graded Product

    Coliform bacteria, abundantly present in the environment, are 
destroyed by pasteurization. Post-pasteurization contamination has 
occurred when coliform bacteria are present in nonfat dry milk. The 
addition of a coliform requirement into the U.S. grade standard 
increases the assurance that USDA graded nonfat dry milk is produced 
and packaged in a sanitary manner.

2. Reduce the Standard Plate Count Requirements

    Enumeration of bacteria by the standard plate count method has been 
a criterium used in the determination of U.S. grade for many years. 
Improvements in the sanitary production of nonfat dry milk have 
resulted in a gradual reduction in the number of bacteria present in 
the product. The proposal would reduce the allowable bacteria from 
50,000 to 40,000 per gram for U.S. Extra Grade and from 100,000 to 
75,000 per gram for U.S. Standard Grade. These proposed changes 
accurately reflect the ability of the U.S. dairy industry to produce 
high-quality nonfat dry milk and enhance the image of U.S. products on 
the world market.

3. Update the Terminology and Format of the Standards

    The current U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process) were last revised in 1984. Since that time, changes in 
terminology and formatting of standards have taken place. The proposal 
would update the standards to provide consistency among the various 
U.S. grade standards.
    USDA grade standards are voluntary standards that are developed 
pursuant to the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et 
seq.) to facilitate the marketing process. Manufacturers of dairy 
products are free to choose whether or not to use these grade 
standards. USDA grade standards for dairy products have been developed 
to identify the degree of quality in the various products. Quality in 
general refers to usefulness, desirability, and value of the product--
its marketability as a commodity. When nonfat dry milk is officially 
graded, the USDA regulations and standards governing the grading of 
manufactured or processed dairy products are used. These regulations 
also require a charge for the grading service provided by USDA. The 
Agency believes this proposal would accurately identify quality 
characteristics in nonfat dry milk.
    Corollary changes are also proposed for the General Specifications 
for Dairy Plants Approved for USDA Inspection and Grading Service, to 
conform the definition of nonfat dry milk set forth therein with the 
proposed revision of the United States Standards for Grades of Nonfat 
Dry Milk (Spray Process).

List of Subjects in 7 CFR Part 58

    Dairy products, Food grades and standards, Food labeling, Reporting 
and recordkeeping requirements.

    For the reasons set forth in the preamble, it is proposed that 7 
CFR Part 58 be amended as follows:

PART 58--[AMENDED]

    1. The authority citation for 7 CFR part 58 continues to read as 
follows:

    Authority: Agricultural Marketing Act of 1946, Secs. 202-208, 60 
Stat. 1087, as amended; 7 U.S.C. 1621-1627, unless otherwise noted.

    2. In Sec. 58.205, paragraph (a) is revised to read as follows:


Sec. 58.205  Meaning of words.

* * * * *
    (a) Nonfat dry milk. The product obtained by the removal of only 
water from pasteurized skim milk. It contains not more than 5 percent 
by weight of moisture and not more than 1\1/2\ percent by weight of 
milkfat and it conforms to the applicable provisions of 21 CFR 131 
``Milk and Cream'' as issued by the Food and Drug Administration. 
Nonfat dry milk shall not contain nor be derived from dry buttermilk, 
dry whey, or products other than skim milk, and shall not contain any 
added preservative, neutralizing agent, or other chemical.
* * * * *
    3. In Part 58, Subpart L is revised to read as follows:

Subpart L--United States Standards for Grades of Nonfat Dry Milk (Spray 
Process)\1\

    \1\ Compliance with these standards does not excuse failure to 
comply with the provisions of the Federal Food, Drug, and Cosmetic 
Act.
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Definitions

Sec.
58.2525  Nonfat dry milk.

U.S. Grades

58.2526  Nomenclature of U.S. grades.
58.2527  Basis for determination of U.S. grade.
58.2528  Specifications for U.S. grades.
58.2529  U.S. grade not assignable.
58.2532  Test methods.

Explanation of Terms

58.2537  Explanation of Terms.

Supplement to U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process): U.S. Heat Treatment Classification

58.2538  Basis for obtaining heat treatment classification.
58.2539  Nomenclature of U.S. Heat Treatment Classification.
58.2540  Basis for determination of U.S. Heat Treatment 
Classification.
58.2541  Test method; whey protein nitrogen.

Subpart L--United States Standards for Grades of Nonfat Dry Milk 
(Spray Process)1

    \1\ Compliance with these standards does not excuse failure to 
comply with the provisions of the Federal Food, Drug, and Cosmetic 
Act.
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Definitions


Sec. 58.2525  Nonfat dry milk.

    (a) ``Nonfat dry milk'' is the product obtained by the removal of 
only water from pasteurized skim milk. It contains not more than 5 
percent by weight of moisture and not more than 1\1/2\ percent by 
weight of milkfat and it conforms to the applicable provisions of 21 
CFR part 131, ``Milk and Cream'' as issued by the Food and Drug 
Administration. Nonfat dry milk covered by these standards shall not 
contain nor be derived from dry buttermilk, dry whey, or products other 
than skim milk, and shall not contain any added preservative, 
neutralizing agent, or other chemical.

U.S. Grades


Sec. 58.2526  Nomenclature of U.S. grades.

    The nomenclature of U.S. grades is as follows:
    (a) U.S. Extra.
    (b) U.S. Standard.


Sec. 58.2527  Basis for determination of U.S. grade.

    (a) The U.S. grade of nonfat dry milk is determined on the basis of 
flavor, physical appearance, bacterial estimate on the basis of 
standard plate count, milkfat content, moisture content, scorched 
particle content, solubility index, and titratable acidity.
    (b) The final U.S. grade shall be established on the basis of the 
lowest rating of any one of the quality factors.


Sec. 58.2528  Specifications for U.S. grades.

    (a) U.S. Extra Grade. U.S. Extra Grade nonfat dry milk shall 
conform to the following requirements (See Tables I, II, and III of 
this section):
    (1) Flavor. Reconstituted nonfat dry milk shall possess a sweet, 
pleasing, and desirable flavor, but may possess the following flavors 
to a slight degree: Chalky, cooked, feed, or flat. See Table I of this 
section. [[Page 12158]] 
    (2) Physical appearance. Nonfat dry milk shall possess a uniform 
white to light cream natural color. It shall be free from lumps, except 
those that readily break up with slight pressure, and be practically 
free from visible dark particles. The reconstituted product shall be 
free from graininess. See Table II of this section.
    (3) Bacterial estimate. Not more than 40,000 per gram standard 
plate count. See Table III of this section.
    (4) Milkfat content. Not more than 1.25 percent. See Table III of 
this section.
    (5) Moisture content. Not more than 4.0 percent. See Table III of 
this section.
    (6) Scorched particle content. Not more than 15.0 mg. See Table III 
of this section.
    (7) Solubility index. Not more than 1.2 ml., except that product 
classified as U.S. High-heat may have not more than 2.0 ml. See Table 
III of this section.
    (8) Titratable acidity. Not more than 0.15 percent (lactic acid). 
See Table III of this section.
    (b) U.S. Standard Grade. U.S. Standard Grade nonfat dry milk shall 
conform to the following requirements (See Tables I, II, and III of 
this section):
    (1) Flavor. Reconstituted nonfat dry milk shall possess a fairly 
pleasing flavor, but may possess the following flavors to a slight 
degree: Bitter, oxidized, scorched, storage, or utensil; the following 
to a definite degree: Chalky, cooked, feed, or flat. See Table I of 
this section.
    (2) Physical appearance. Nonfat dry milk may possess a slight 
unnatural color. It shall be free from lumps, except those that break 
readily under moderate pressure, and be reasonably free from visible 
dark particles. The reconstituted product shall be reasonably free from 
graininess. See Table II of this section.
    (3) Bacterial estimate. Not more than 75,000 per gram standard 
plate count. See Table III of this section.
    (4) Milkfat content. Not more than 1.50 percent. See Table III of 
this section.
    (5) Moisture content. Not more than 5.0 percent. See Table III of 
this section.
    (6) Scorched particle content. Not more than 22.5 mg. See Table III 
of this section.
    (7) Solubility index. Not more than 2.0 ml., except that product 
classified as U.S. High-heat may have not more than 2.5 ml. See Table 
III of this section.
    (8) Titratable acidity. Not more than 0.17 percent (lactic acid). 
See Table III of this section.

    Table I.--Classification of Flavor With Corresponding U.S. Grade    
------------------------------------------------------------------------
                                                          U.S. standard 
       Flavor characteristics         U.S. extra grade        grade     
------------------------------------------------------------------------
Bitter..............................  --                S               
Chalky..............................  S                 D               
Cooked..............................  S                 D               
Feed................................  S                 D               
Flat................................  S                 D               
Oxidized............................  --                S               
Scorched............................  --                S               
Storage.............................  --                S               
Utensil.............................  --                S               
------------------------------------------------------------------------
(--) = Not permitted  S = Slight  D = Definite.                         


                 Table II.--Classification of Physical Appearance With Corresponding U.S. Grade                 
----------------------------------------------------------------------------------------------------------------
            Physical appearance characteristics                  U.S. extra grade         U.S. standard grade   
----------------------------------------------------------------------------------------------------------------
Dry Product:                                                                                                    
    Lumpy.................................................  Slight...................  Moderate.                
    Unnatural color.......................................  --                         Slight.                  
    Visible dark particles................................  Practically free.........  Reasonably free.         
Reconstituted Product:                                                                                          
    Grainy................................................  --                         Reasonably free.         
----------------------------------------------------------------------------------------------------------------
(--) = Not permitted.                                                                                           


    Table III.--Classification According to Laboratory Analysis With    
                        Corresponding U.S. Grade                        
------------------------------------------------------------------------
                                                                U.S.    
              Laboratory tests                 U.S. extra     standard  
                                                  grade         grade   
------------------------------------------------------------------------
Bacterial estimate; Standard plate count;                               
 per gram (max).............................     40,000        75,000   
Milkfat content; percent (max)..............          1.25          1.50
Moisture content; percent (max).............          4.0           5.0 
Scorched particle content; mg (max).........         15.0          22.5 
Solubility index; ml (max)..................          1.2           2.0 
    U.S. High-heat (max)....................          2.0           2.5 
Titratable acidity (lactic acid); percent                               
 (max)......................................          0.15          0.17
------------------------------------------------------------------------

Sec. 58.2529  U.S. grade not assignable.

    Nonfat dry milk shall not be assigned a U.S. grade for one or more 
of the following reasons:
    (a) The nonfat dry milk fails to meet or exceed the requirements 
for U.S. Standard Grade.
    (b) The nonfat dry milk has a direct microscopic clump (DMC) count 
exceeding 100 million per gram.
    (c) The nonfat dry milk has a coliform count exceeding 10 per gram.
    (d) The nonfat dry milk is produced in a plant that is rated 
ineligible for USDA grading service or is not USDA-
approved. [[Page 12159]] 


Sec. 58.2532  Test methods.

    All required tests shall be performed in accordance with DA 
Instruction No. 918-RL, ``Instruction for Resident Grading Quality 
Control Service Programs and Laboratory Analysis,'' Dairy Grading 
Branch, Dairy Division, Agricultural Marketing Service, U.S. Department 
of Agriculture, Washington, DC 20090-6456; the latest revision of 
``Official Methods of Analysis of the Association of Official 
Analytical Chemists''; or the latest edition of ``Standard Methods for 
the Examination of Dairy Products'', available from the American Public 
Health Association, 1015 Fifteenth Street NW., Washington, DC 20005.

Explanation of Terms


Sec. 58.2537  Explanation of terms.

    (a) With respect to flavor:
    (1) Slight. Detected only upon critical examination.
    (2) Definite. Not intense but detectable.
    (3) Bitter. Distasteful, similar to the taste of quinine.
    (4) Chalky. A tactual type of flavor lacking in characteristic milk 
flavor.
    (5) Cooked. Similar to a custard flavor and imparts a smooth 
aftertaste.
    (6) Feed. Feed flavors (such as alfalfa, sweetclover, silage, or 
similar feed) in milk carried through into the nonfat dry milk.
    (7) Flat. Insipid, practically devoid of any characteristic 
reconstituted nonfat dry milk flavor.
    (8) Oxidized. A flavor resembling cardboard and sometimes referred 
to as ``cappy'' or ``tallowy''.
    (9) Scorched. A more intensified flavor than ``cooked'' and imparts 
a burnt aftertaste.
    (10) Storage. Lacking in freshness and imparting a ``stale'' 
aftertaste.
    (11) Utensil. A flavor that is suggestive of improper or inadequate 
washing and sanitation of milking machines, utensils, or manufacturing 
equipment.
    (b) With respect to physical appearance:
    (1) Practically free. Present only upon very critical examination.
    (2) Reasonably free. Present only upon critical examination.
    (3) Slight pressure. Only sufficient pressure to disintegrate the 
lumps readily.
    (4) Moderate pressure. Only sufficient pressure to disintegrate the 
lumps easily.
    (5) Grainy. Minute particles of undissolved powder appearing in a 
thin film on the surface of a glass or tumbler.
    (6) Lumpy. Loss of powdery consistency but not caked into hard 
chunks.
    (7) Natural color. A color that is white to light cream.
    (8) Unnatural color. A color that is more intense than light cream 
and is brownish, dull, or grey-like.
    (9) Visible dark particles. The presence of scorched or discolored 
specks.

Supplement to U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process): U.S. Heat Treatment Classification


Sec. 58.2538  Basis for obtaining heat treatment classification.

    Heat treatment classification is not a U.S. grade requirement 
except in cases when the higher solubility index specified for U.S. 
High-heat product is permitted. In all other instances, product 
submitted for USDA grading may be analyzed for heat treatment 
classification upon request and the results shown on the grading 
certificate. Heat treatment classification will be made available only 
upon a product graded by USDA.


Sec. 58.2339  Nomenclature of U.S. Heat Treatment Classification.

    The nomenclature of U.S. Heat Treatment Classification is as 
follows:
    (a) U.S. High-heat.
    (b) U.S. Medium-heat.
    (c) U.S. Low-heat.


Sec. 58.2540  Basis for determination of U.S. Heat Treatment 
Classification.

    The whey protein nitrogen test shall be used in determining the 
heat treatment classification as follows:
    (a) U.S. High-heat. The finished product shall not exceed 1.50 mg. 
undenatured whey protein nitrogen per gram of nonfat dry milk.
    (b) U.S. Medium-heat. The finished product shall exceed 1.50 mg. 
undenatured whey protein nitrogen per gram of nonfat dry milk and shall 
be less than 6.00 mg. undenatured whey protein nitrogen per gram of 
nonfat dry milk.
    (c) U.S. Low-heat. The finished product shall be not less than 6.00 
mg. undenatured whey protein nitrogen per gram of nonfat dry milk.


Sec. 58.2541  Test method; whey protein nitrogen.

    The whey protein nitrogen test shall be performed in accordance 
with DA Instruction 918-RL, ``Instruction for Resident Grading Quality 
Control Service Programs and Laboratory Analysis,'' Dairy Grading 
Branch, Dairy Division, Agricultural Marketing Service, U. S. 
Department of Agriculture, Washington, DC 20090-6456, or the latest 
edition of ``Standard Methods for the Examination of Dairy Products'', 
available from the American Public Health Association, 1015 Fifteenth 
Street, NW., Washington, DC 20005.

    Dated: February 24, 1995.
Kenneth C. Clayton,
Acting Administrator.
[FR Doc. 95-5293 Filed 3-3-95; 8:45 am]
BILLING CODE 3410-02-P