[Federal Register Volume 61, Number 131 (Monday, July 8, 1996)]
[Rules and Regulations]
[Pages 35589-35592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17200]


=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: This document revises the United States Standards for Instant 
Nonfat Dry Milk. The revision limits the use of lactose as a processing 
aid in the instantizing process, provides fortification levels for 
instant nonfat dry milk with added vitamins A and D, and deletes the 
optional phosphatase test. This revision was developed in cooperation 
with the American Dairy Products Institute and other dairy trade 
associations.

EFFECTIVE DATE: August 7, 1996.

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 final rule has been reviewed under 
Executive Order 12778, Civil Justice Reform. This action is not 
intended to have retroactive effect. This rule does 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 final 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 final rule will 
not have a significant economic impact on a substantial number of small 
entities because use of the standards is voluntary and the revisions do 
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 revising the U.S. Standards for Instant Nonfat Dry Milk as 
follows:

1. 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. The revision permits 
the use of lactose as a processing aid and restricts the amount added 
to a maximum of 2.0 percent of the weight of the nonfat dry milk.

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

    Previously, the U.S. Standards for Instant Nonfat Dry Milk have not 
provided fortification levels for product with added vitamins A and D. 
This revision incorporates 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).

3. 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

[[Page 35590]]

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 provides adequate assurance that the 
instant nonfat dry milk has been properly pasteurized. For this reason, 
the Department has deleted the reference to the optional phosphatase 
test that appears in 7 CFR Sec. 58.2756. This action does not prohibit 
using the phosphatase test upon request.

4. 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 revision updates 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 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 revision accurately identifies quality 
characteristics in instant nonfat dry milk.
    Corollary changes are also made 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 revision of the United States Standards for Instant Nonfat Dry 
Milk.

Public Comments

    On March 6, 1995, the Department published a proposed rule (60 FR 
12154) to revise the United States Standards for Instant Nonfat Dry 
Milk. The public comment period closed on May 5, 1995. One institute 
representing the dry milk industry submitted comments.

Discussion of Comments

    The commenter supported all of the proposed changes except for the 
lowering of the direct microscopic clump (DMC) count from 75 to 40 
million per gram. The commenter suggested deletion of this requirement 
from the standard and provided the following comments in support of 
this position.
    1. The accuracy and reproducibility of the DMC count results is 
unreliable.
    2. A 0.1 milliliter sample of reconstituted instant nonfat dry milk 
is an extremely small sample to evaluate a large volume of product.
    3. Grade A milk is used to manufacture most instant nonfat dry milk 
produced in the United States. The maximum allowable bacteria in Grade 
A raw milk is less than the maximum allowed in manufacturing grade 
milk. The production of manufacturing grade milk has decreased since 
the last revision of this standard and provides instant nonfat dry milk 
with lower DMC counts. (This fact was submitted to support the deletion 
of DMC count requirements.)
    4. Requirements for Grade A (the designation of the National 
Conference on Interstate Milk Shippers, not an indication of USDA 
quality grade) instant nonfat dry milk do not include DMC count limits.
    5. The Codex Alimentarius ``Standard for Whole Milk Powder, Partly 
Skimmed Milk Powder and Skimmed Milk Powder'' does not provide DMC 
count limits for product in international trade.
    The comments pertaining to the accuracy, reproducibility, and small 
sample size become increasingly valid as DMC count limits are lowered. 
The Department accepts these concerns and elects not to lower the DMC 
count limits at this time.
    The Department disagrees with the request for deletion of the DMC 
count requirement. U.S. Grade Standards are quality standards and 
differ from standards developed by the National Conference on 
Interstate Milk Shipments and The Codex Alimentarius Commission. The 
U.S. Standards for Instant Nonfat Dry Milk will retain the DMC count 
maximum requirement of 75 million per gram.

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, 7 CFR Part 58 is amended 
as follows:

PART 58--[AMENDED]

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

    Authority: 7 U.S.C. 1621-1627.

    2. In Part 58, Sec. 58.205 paragraph (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

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.

[[Page 35591]]

Subpart U--United States Standards for Instant Nonfat Dry Milk 
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.
---------------------------------------------------------------------------

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

    (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 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.
    (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.
    (b) [Reserved]

           Table I of Sec.  58.2753--Classification of Flavor           
------------------------------------------------------------------------
           Flavor characteristics                  U.S. extra grade     
------------------------------------------------------------------------
Chalky.....................................  Slight.                    
Cooked.....................................  Slight.                    
Feed.......................................  Slight.                    
Flat.......................................  Slight.                    
------------------------------------------------------------------------


    Table II of Sec.  58.2753--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 of Sec.  58.2753--Classification According to Laboratory   
                                Analysis                                
------------------------------------------------------------------------
                                                                  U.S.  
                       Laboratory tests                          extra  
                                                                 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 75 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.

[[Page 35592]]

    (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: June 28, 1996.
Lon Hatamiya,
Administrator.
[FR Doc. 96-17200 Filed 7-5-96; 8:45 am]
BILLING CODE 3410-02-P