96-17200. Grading and Inspection, General Specification for Approved Plants and Standards for Grades of Dairy Products; United States Standards for Instant Nonfat Dry Milk  

  • [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]
    
    
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    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.
    
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    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.
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        \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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        (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
    
    
    

Document Information

Effective Date:
8/7/1996
Published:
07/08/1996
Department:
Agricultural Marketing Service
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-17200
Dates:
August 7, 1996.
Pages:
35589-35592 (4 pages)
Docket Numbers:
DA-93-04
PDF File:
96-17200.pdf
CFR: (8)
7 CFR 58.205
7 CFR 58.2750
7 CFR 58.2751
7 CFR 58.2752
7 CFR 58.2753
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