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

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

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Flavor characteristics U.S. extra grade

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Chalky..................................... Slight.

Cooked..................................... Slight.

Feed....................................... Slight.

Flat....................................... Slight.

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Table II of Sec. 58.2753--Classification of Physical Appearance

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Physical appearance characteristics U.S. extra grade

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Color.................................. White to light

cream.

Free flowing........................... Reasonably.

Lumpy.................................. Very slight

pressure.

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Table III of Sec. 58.2753--Classification According to Laboratory

Analysis

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U.S.

Laboratory tests extra

grade

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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

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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