[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12154-12156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5295]



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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed 
Rules
[[Page 12154]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 58

[DA-93-04]


Grading and Inspection, General Specification for Approved Plants 
and Standards for Grades of Dairy Products; United States Standards for 
Instant Nonfat Dry Milk

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This document proposes to revise the United States Standards 
for Instant Nonfat Dry Milk. The proposed changes would reduce the 
direct microscopic clump count, limit the use of lactose as a 
processing aid in the instantizing process, provide fortification 
levels for instant nonfat dry milk with added vitamins A and D, and 
delete the optional phosphatase test. This proposal was developed in 
cooperation with the American Dairy Products Institute and other dairy 
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 instant nonfat dry milk, 
USDA is proposing the following changes in the U.S. Standards for 
Instant Nonfat Dry Milk.

1. Reduce the Direct Microscopic Clump (DMC) Count Requirements

    For many years, the enumeration of bacteria in instant nonfat dry 
milk by the direct microscopic clump (DMC) count method has been used 
as a means of determining the quality of the product. Improvements in 
the quality of raw milk and the sanitary production of instant nonfat 
dry milk have resulted in a reduction in the DMC count. Proposed 
changes to reduce the allowable DMC count from 75 million per gram to 
40 million per gram would more accurately reflect the ability of the 
U.S. dairy industry to produce high quality instant nonfat dry milk.

2. Restrict the Amount of Lactose Used as a Processing Aid

    The use of lactose as a processing aid in the production of instant 
nonfat dry milk is an acceptable practice provided the amount used does 
not exceed the amount necessary to produce the desired effect. If more 
lactose than necessary is added, the additional lactose serves no 
purpose other than to displace nonfat dry milk. Proposed changes would 
permit the use of lactose as a processing aid and restrict the amount 
added to a maximum of 2.0 percent of the weight of the nonfat dry milk.

3. Provide Fortification Levels for Instant Nonfat Dry Milk With 
Added Vitamins A and D

    The current U.S. Standards for Instant Nonfat Dry Milk do not 
provide fortification levels for product with added vitamins A and D. 
Proposed changes would incorporate fortification levels that are 
consistent with the Food and Drug Administration's standards of 
identity for nonfat dry milk fortified with vitamins A and D (21 CFR 
131.127).

4. Delete the Reference to the Optional Phosphatase Test

    Pasteurization destroys pathogenic organisms and occurs when milk 
is heated to pasteurization temperature and held at that temperature 
for a specified period of time. To be considered pasteurized, the 
heating and holding of milk must take place in properly designed and 
installed equipment which has been inspected and sealed by the State 
Regulatory Agency. Phosphatase testing confirms only that a given 
sample of instant nonfat dry milk has been pasteurized but does not 
ensure that pasteurization has occurred for product manufactured before 
and after the sample tested.
    Before U.S. grade can be assigned to instant nonfat dry milk, it 
must be produced in a dairy plant which has been inspected by USDA. 
When a USDA dairy plant inspection is conducted, the inspector 
evaluates the pasteurization system for compliance with program 
requirements.
    The Department believes that the inspection and sealing of 
pasteurization equipment by the State Regulatory Agency and a review of 
the system by the USDA inspector provide adequate assurance that the 
instant nonfat dry milk has been properly pasteurized. For this reason, 
the Department is proposing to delete the reference to the optional 
phosphatase test that appears in 7 CFR part 58.2756. This action does 
not prohibit using the phosphatase test upon request.

5. Update the Terminology and Format of the Standards

    The current U.S. Standards for Instant Nonfat Dry Milk 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 [[Page 12155]] 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 instant 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 instant 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 instant nonfat dry milk set forth therein 
with the proposed revision of the United States Standards for Instant 
Nonfat Dry Milk.

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 subpart B, Sec. 58.205 (b) is revised to read as follows:


Sec. 58.205  Meaning of words.

* * * * *
    (b) Instant nonfat dry milk. Instant nonfat dry milk is nonfat dry 
milk which has been produced in such a manner as to substantially 
improve its dispersing and reconstitution characteristics over that 
produced by the conventional process. Instant nonfat dry milk shall not 
contain dry buttermilk, dry whey, or products other than nonfat dry 
milk, except that lactose may be added as a processing aid during 
instantizing. The instant nonfat dry milk shall not contain any added 
preservatives, neutralizing agent, or other chemical. If lactose is 
used, the amount of lactose shall be the minimum required to produce 
the desired effect, but in no case shall the amount exceed 2.0 percent 
of the weight of the nonfat dry milk. If instant nonfat dry milk is 
fortified with vitamin A, and the product is reconstituted in 
accordance with the label directions, each quart of the reconstituted 
product shall contain 2000 International Units thereof. If instant 
nonfat dry milk is fortified with vitamin D, and the product is 
reconstituted in accordance with the label directions, each quart of 
the reconstituted product shall contain 400 International Units 
thereof.
* * * * *
    3. In Part 58, Subpart U is revised to read as follows:

Subpart U--United States Standards for Instant Nonfat Dry Milk\1\

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

Sec.
58.2750  Instant nonfat dry milk.

U.S. Grade

58.2751  Nomenclature of the U.S. grade.
58.2752  Basis for determination of the U.S. grade.
58.2753  Specifications for the U.S. grade.
58.2754  U.S. grade not assignable.
58.2756  Test methods.

Explanation of Terms

58.2759  Explanation of terms.



Subpart U--United States Standards for Instant Nonfat Dry 
Milk<SUP>1

Definitions


Sec. 58.2750  Instant nonfat dry milk.

    (a) Instant nonfat dry milk is nonfat dry milk which has been 
produced in such a manner as to substantially improve its dispersing 
and reconstitution characteristics over that produced by the 
conventional processes. Instant nonfat dry milk covered by these 
standards shall not contain dry buttermilk, dry whey, or products other 
than nonfat dry milk, except that lactose may be added as a processing 
aid during instantizing. The instant nonfat dry milk shall not contain 
any added preservatives, neutralizing agent, or other chemical. If 
lactose is used, the amount of lactose shall be the minimum required to 
produce the desired effect, but in no case shall the amount exceed 2.0 
percent of the weight of the nonfat dry milk. If instant nonfat dry 
milk is fortified with vitamin A, and the product is reconstituted in 
accordance with the label directions, each quart of the reconstituted 
product shall contain 2000 International Units thereof. If instant 
nonfat dry milk is fortified with vitamin D, and the product is 
reconstituted in accordance with the label directions, each quart of 
the reconstituted product shall contain 400 International Units 
thereof.
    (b) ``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 or 21 
CFR part 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.

U.S. Grade


Sec. 58.2751  Nomenclature of the U.S. grade.

    The nomenclature of the U.S. grade is U.S. Extra.


Sec. 58.2752  Basis for determination of the U.S. grade.

    The U.S. grade of instant nonfat dry milk is determined on the 
basis of flavor, physical appearance, bacterial estimate on the basis 
of standard plate count and coliform count, milkfat content, moisture 
content, scorched particle content, solubility index, titratable 
acidity, and dispersibility.


Sec. 58.2753  Specifications for the U.S. grade.

    (a) U.S. Extra Grade. U.S. Extra Grade instant nonfat dry milk 
shall conform to the following requirements (See Tables I, II, and III 
of this section):
    (1) Flavor. Reconstituted instant 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.
    (2) Physical appearance. Instant nonfat dry milk shall possess a 
uniform white to light cream natural color. It shall be reasonably 
free-flowing and free from lumps except those that readily break up 
with very slight pressure. See Table II of this section.
    (3) Bacterial estimate. Not more than 30,000 per gram standard 
plate count. See Table III of this section.
    (4) Coliform count. Not more than 10 per gram. See Table III of 
this section.
    (5) Milkfat content. Not more than 1.25 percent. See Table III of 
this section. [[Page 12156]] 
    (6) Moisture content. Not more than 4.5 percent. See Table III of 
this section.
    (7) Scorched particle content. Not more than 15.0 mg. See Table III 
of this section.
    (8) Solubility index. Not more than 1.0 ml. See Table III of this 
section.
    (9) Titratable acidity. Not more than 0.15 percent (lactic acid). 
See Table III of this section.
    (10) Dispersibility. Not less than 85.0 percent. See Table III of 
this section.

                   Table I.--Classification of Flavor                   
------------------------------------------------------------------------
                                                             U.S. extra 
                  Flavor characteristics                       grade    
------------------------------------------------------------------------
Chalky...................................................  Slight.      
Cooked...................................................  Slight.      
Feed.....................................................  Slight.      
Flat.....................................................  Slight.      
------------------------------------------------------------------------


            Table II.--Classification of Physical Appearance            
------------------------------------------------------------------------
Physical appearance characteristics            U.S. extra grade         
------------------------------------------------------------------------
Color..............................  White to light cream.              
Free flowing.......................  Reasonably.                        
Lumpy..............................  Very slight pressure.              
------------------------------------------------------------------------


       Table III.--Classification According to Laboratory Analysis      
------------------------------------------------------------------------
                                                              U.S. extra
                      Laboratory tests                           grade  
------------------------------------------------------------------------
Bacterial estimate; Standard plate count; per gram (max)....   30,000   
Coliform count; per gram (max)..............................       10   
Milkfat content; percent (max)..............................        1.25
Moisture content; percent (max).............................        4.5 
Scorched particle content; mg (max).........................       15.0 
Solubility index; ml (max)..................................        1.0 
Titratable acidity (lactic acid); percent (max).............        0.15
Dispersibility; percent (min)...............................       85.0 
------------------------------------------------------------------------

Sec. 58.2754  U.S. grade not assignable.

    Instant nonfat dry milk shall not be assigned the U.S. grade for 
one or more of the following reasons:
    (a) The instant nonfat dry milk fails to meet the requirements for 
U.S. Extra Grade.
    (b) The instant nonfat dry milk has a direct microscopic clump 
(DMC) count exceeding 40 million per gram.
    (c) The instant nonfat dry milk is produced in a plant that is 
rated ineligible for USDA grading service or is not USDA-approved.


Sec. 58.2756  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. 58.2759  Explanation of terms.

    (a) With respect to flavor:
    (1) Slight. Detected only upon critical examination.
    (2) Chalky. A tactual type of flavor lacking in characteristic milk 
flavor.
    (3) Cooked. Similar to a custard flavor and imparts a smooth 
aftertaste.
    (4) Feed. Feed flavors (such as alfalfa, sweet clover, silage, or 
similar feed) in milk carried through into the instant nonfat dry milk.
    (5) Flat. Insipid, practically devoid of any characteristic 
reconstituted instant nonfat dry milk flavor.
    (b) With respect to physical appearance:
    (1) Reasonably free-flowing. Pours in a fairly constant, uniform 
stream from the open end of a tilted container or scoop.
    (2) Very slight pressure. Lumps fall apart with only light touch.
    (3) Lumpy. Loss of powdery consistency but not caked into hard 
chunks.
    (4) Natural color. A color that is white to light cream.

    Dated: February 24, 1995.
Kenneth C. Clayton,
Acting Administrator.
[FR Doc. 95-5295 Filed 3-3-95; 8:45 am]
BILLING CODE 3410-2-P