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.

Proposed Rules Federal Register

12154

Vol. 60, No. 43

Monday, March 6, 1995

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.

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
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12155

1Compliance with the standards in this subpart

does not excuse failure to comply with the

provisions of the Federal Food, Drug, and Cosmetic

Act.

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, § 58.205 (b) is revised

to read as follows:

§ 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

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 1

Definitions

§ 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 11⁄2 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

§ 58.2751 Nomenclature of the U.S. grade.

The nomenclature of the U.S. grade is

U.S. Extra.

§ 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.

§ 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.
12156 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

(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

Flavor characteristics U.S. extra

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

Laboratory tests U.S. 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

§ 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.

§ 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

§ 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

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.

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).