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).
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12157

1 Compliance with these standards does not

excuse failure to comply with the provisions of the

Federal Food, Drug, and Cosmetic Act.

1 Compliance with these standards does not

excuse failure to comply with the provisions of the

Federal Food, Drug, and Cosmetic Act.

1. Expand the U.S. Grade Standards To

Include a Maximum Coliform Count in

USDA-Graded Product

Coliform bacteria, abundantly present

in the environment, are destroyed by

pasteurization. Post-pasteurization

contamination has occurred when

coliform bacteria are present in nonfat

dry milk. The addition of a coliform

requirement into the U.S. grade

standard increases the assurance that

USDA graded nonfat dry milk is

produced and packaged in a sanitary

manner.

2. Reduce the Standard Plate Count

Requirements

Enumeration of bacteria by the

standard plate count method has been a

criterium used in the determination of

U.S. grade for many years.

Improvements in the sanitary

production of nonfat dry milk have

resulted in a gradual reduction in the

number of bacteria present in the

product. The proposal would reduce the

allowable bacteria from 50,000 to 40,000

per gram for U.S. Extra Grade and from

100,000 to 75,000 per gram for U.S.

Standard Grade. These proposed

changes accurately reflect the ability of

the U.S. dairy industry to produce highquality nonfat dry milk and enhance the

image of U.S. products on the world

market.

3. Update the Terminology and Format

of the Standards

The current U.S. Standards for Grades

of Nonfat Dry Milk (Spray Process) 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 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 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 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 nonfat dry milk set forth

therein with the proposed revision of

the United States Standards for Grades

of Nonfat Dry Milk (Spray Process).

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 § 58.205, paragraph (a) is revised

to read as follows:

§ 58.205 Meaning of words.

* * * * *

(a) Nonfat dry milk. 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 of 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.

* * * * *

3. In Part 58, Subpart L is revised to

read as follows:

Subpart L—United States Standards for

Grades of Nonfat Dry Milk (Spray Process) 1

Definitions

Sec.

58.2525 Nonfat dry milk.

U.S. Grades

58.2526 Nomenclature of U.S. grades.

58.2527 Basis for determination of U.S.

grade.

58.2528 Specifications for U.S. grades.

58.2529 U.S. grade not assignable.

58.2532 Test methods.

Explanation of Terms

58.2537 Explanation of Terms.

Supplement to U.S. Standards for Grades of

Nonfat Dry Milk (Spray Process): U.S. Heat

Treatment Classification

58.2538 Basis for obtaining heat treatment

classification.

58.2539 Nomenclature of U.S. Heat

Treatment Classification.

58.2540 Basis for determination of U.S.

Heat Treatment Classification.

58.2541 Test method; whey protein

nitrogen.

Subpart L—United States Standards

for Grades of Nonfat Dry Milk (Spray

Process) 1

Definitions

§ 58.2525 Nonfat dry milk.

(a) ‘‘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 of 21 CFR part

131, ‘‘Milk and Cream’’ as issued by the

Food and Drug Administration. Nonfat

dry milk covered by these standards

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. Grades

§ 58.2526 Nomenclature of U.S. grades.

The nomenclature of U.S. grades is as

follows:

(a) U.S. Extra.

(b) U.S. Standard.

§ 58.2527 Basis for determination of U.S.

grade.

(a) The U.S. grade of nonfat dry milk

is determined on the basis of flavor,

physical appearance, bacterial estimate

on the basis of standard plate count,

milkfat content, moisture content,

scorched particle content, solubility

index, and titratable acidity.

(b) The final U.S. grade shall be

established on the basis of the lowest

rating of any one of the quality factors.

§ 58.2528 Specifications for U.S. grades.

(a) U.S. Extra Grade. U.S. Extra Grade

nonfat dry milk shall conform to the

following requirements (See Tables I, II,

and III of this section):

(1) Flavor. Reconstituted 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.
12158 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

(2) Physical appearance. Nonfat dry

milk shall possess a uniform white to

light cream natural color. It shall be free

from lumps, except those that readily

break up with slight pressure, and be

practically free from visible dark

particles. The reconstituted product

shall be free from graininess. See Table

II of this section.

(3) Bacterial estimate. Not more than

40,000 per gram standard plate count.

See Table III of this section.

(4) Milkfat content. Not more than

1.25 percent. See Table III of this

section.

(5) Moisture content. Not more than

4.0 percent. See Table III of this section.

(6) Scorched particle content. Not

more than 15.0 mg. See Table III of this

section.

(7) Solubility index. Not more than 1.2

ml., except that product classified as

U.S. High-heat may have not more than

2.0 ml. See Table III of this section.

(8) Titratable acidity. Not more than

0.15 percent (lactic acid). See Table III

of this section.

(b) U.S. Standard Grade. U.S.

Standard Grade nonfat dry milk shall

conform to the following requirements

(See Tables I, II, and III of this section):

(1) Flavor. Reconstituted nonfat dry

milk shall possess a fairly pleasing

flavor, but may possess the following

flavors to a slight degree: Bitter,

oxidized, scorched, storage, or utensil;

the following to a definite degree:

Chalky, cooked, feed, or flat. See Table

I of this section.

(2) Physical appearance. Nonfat dry

milk may possess a slight unnatural

color. It shall be free from lumps, except

those that break readily under moderate

pressure, and be reasonably free from

visible dark particles. The reconstituted

product shall be reasonably free from

graininess. See Table II of this section.

(3) Bacterial estimate. Not more than

75,000 per gram standard plate count.

See Table III of this section.

(4) Milkfat content. Not more than

1.50 percent. See Table III of this

section.

(5) Moisture content. Not more than

5.0 percent. See Table III of this section.

(6) Scorched particle content. Not

more than 22.5 mg. See Table III of this

section.

(7) Solubility index. Not more than 2.0

ml., except that product classified as

U.S. High-heat may have not more than

2.5 ml. See Table III of this section.

(8) Titratable acidity. Not more than

0.17 percent (lactic acid). See Table III

of this section.

TABLE I.—CLASSIFICATION OF FLAVOR WITH CORRESPONDING U.S. GRADE

Flavor characteristics U.S. extra

grade

U.S. standard

grade

Bitter ........................................................................................................................................................................... — S

Chalky ........................................................................................................................................................................ S D

Cooked ....................................................................................................................................................................... S D

Feed ........................................................................................................................................................................... S D

Flat ............................................................................................................................................................................. S D

Oxidized ..................................................................................................................................................................... — S

Scorched .................................................................................................................................................................... — S

Storage ....................................................................................................................................................................... — S

Utensil ........................................................................................................................................................................ — S

(—) = Not permitted S = Slight D = Definite.

TABLE II.—CLASSIFICATION OF PHYSICAL APPEARANCE WITH CORRESPONDING U.S. GRADE

Physical appearance characteristics U.S. extra grade U.S. standard grade

Dry Product:

Lumpy ........................................................................................................................................... Slight ....................... Moderate.

Unnatural color ............................................................................................................................. — Slight.

Visible dark particles .................................................................................................................... Practically free ......... Reasonably free.

Reconstituted Product:

Grainy ........................................................................................................................................... — Reasonably free.

(—) = Not permitted.

TABLE III.—CLASSIFICATION ACCORDING TO LABORATORY ANALYSIS WITH CORRESPONDING U.S. GRADE

Laboratory tests U.S. extra

grade

U.S. standard grade

Bacterial estimate; Standard plate count; per gram (max) ......................................................................................... 40,000 75,000

Milkfat content; percent (max) ..................................................................................................................................... 1.25 1.50

Moisture content; percent (max) .................................................................................................................................. 4.0 5.0

Scorched particle content; mg (max) ........................................................................................................................... 15.0 22.5

Solubility index; ml (max) ............................................................................................................................................. 1.2 2.0

U.S. High-heat (max) ............................................................................................................................................ 2.0 2.5

Titratable acidity (lactic acid); percent (max) ............................................................................................................... 0.15 0.17

§ 58.2529 U.S. grade not assignable.

Nonfat dry milk shall not be assigned

a U.S. grade for one or more of the

following reasons:

(a) The nonfat dry milk fails to meet

or exceed the requirements for U.S.

Standard Grade.

(b) The nonfat dry milk has a direct

microscopic clump (DMC) count

exceeding 100 million per gram.

(c) The nonfat dry milk has a coliform

count exceeding 10 per gram.

(d) The nonfat dry milk is produced

in a plant that is rated ineligible for

USDA grading service or is not USDAapproved.
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12159

§ 58.2532 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

§ 58.2537 Explanation of terms.

(a) With respect to flavor:

(1) Slight. Detected only upon critical

examination.

(2) Definite. Not intense but

detectable.

(3) Bitter. Distasteful, similar to the

taste of quinine.

(4) Chalky. A tactual type of flavor

lacking in characteristic milk flavor.

(5) Cooked. Similar to a custard flavor

and imparts a smooth aftertaste.

(6) Feed. Feed flavors (such as alfalfa,

sweetclover, silage, or similar feed) in

milk carried through into the nonfat dry

milk.

(7) Flat. Insipid, practically devoid of

any characteristic reconstituted nonfat

dry milk flavor.

(8) Oxidized. A flavor resembling

cardboard and sometimes referred to as

‘‘cappy’’ or ‘‘tallowy’’.

(9) Scorched. A more intensified

flavor than ‘‘cooked’’ and imparts a

burnt aftertaste.

(10) Storage. Lacking in freshness and

imparting a ‘‘stale’’ aftertaste.

(11) Utensil. A flavor that is

suggestive of improper or inadequate

washing and sanitation of milking

machines, utensils, or manufacturing

equipment.

(b) With respect to physical

appearance:

(1) Practically free. Present only upon

very critical examination.

(2) Reasonably free. Present only

upon critical examination.

(3) Slight pressure. Only sufficient

pressure to disintegrate the lumps

readily.

(4) Moderate pressure. Only sufficient

pressure to disintegrate the lumps

easily.

(5) Grainy. Minute particles of

undissolved powder appearing in a thin

film on the surface of a glass or tumbler.

(6) Lumpy. Loss of powdery

consistency but not caked into hard

chunks.

(7) Natural color. A color that is white

to light cream.

(8) Unnatural color. A color that is

more intense than light cream and is

brownish, dull, or grey-like.

(9) Visible dark particles. The

presence of scorched or discolored

specks.

Supplement to U.S. Standards for

Grades of Nonfat Dry Milk (Spray

Process): U.S. Heat Treatment

Classification

§ 58.2538 Basis for obtaining heat

treatment classification.

Heat treatment classification is not a

U.S. grade requirement except in cases

when the higher solubility index

specified for U.S. High-heat product is

permitted. In all other instances,

product submitted for USDA grading

may be analyzed for heat treatment

classification upon request and the

results shown on the grading certificate.

Heat treatment classification will be

made available only upon a product

graded by USDA.

§ 58.2339 Nomenclature of U.S. Heat

Treatment Classification.

The nomenclature of U.S. Heat

Treatment Classification is as follows:

(a) U.S. High-heat.

(b) U.S. Medium-heat.

(c) U.S. Low-heat.

§ 58.2540 Basis for determination of U.S.

Heat Treatment Classification.

The whey protein nitrogen test shall

be used in determining the heat

treatment classification as follows:

(a) U.S. High-heat. The finished

product shall not exceed 1.50 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk.

(b) U.S. Medium-heat. The finished

product shall exceed 1.50 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk and shall be

less than 6.00 mg. undenatured whey

protein nitrogen per gram of nonfat dry

milk.

(c) U.S. Low-heat. The finished

product shall be not less than 6.00 mg.

undenatured whey protein nitrogen per

gram of nonfat dry milk.

§ 58.2541 Test method; whey protein

nitrogen.

The whey protein nitrogen test shall

be performed in accordance with DA

Instruction 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, 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.

Dated: February 24, 1995.

Kenneth C. Clayton,

Acting Administrator.

[FR Doc. 95–5293 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–02–P

Animal and Plant Health Inspection

Service

9 CFR Parts 102, 104, 105, and 116

[Docket No. 93–072–1]

Viruses, Serums, Toxins, and

Analogous Products; Licenses,

Inspections, Records, and Reports

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations under the Virus-SerumToxin Act to clarify certain provisions

concerning licenses, inspections,

records, and reports. The effect of the

rule is to ensure that licensees are aware

of the fact that licenses are issued on the

condition that the licensee permit

inspection of establishments, products,

and records, and that a licensee must

have at least one product license in

order to maintain a valid establishment

license. Failure to permit inspection

would make the license subject to

suspension or revocation. We are also

proposing amendments concerning the

content of records and reports and their

availability for inspection. The

proposed rule is necessary to clarify and

simplify certain provisions of the

regulations.

DATES: Consideration will be given only

to comments received on or before May

5, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 93–072–1, Animal and Plant

Health Inspection Service, Regulatory

Analysis and Development, Program

and Policy Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 93–072–1.

Comments received may be inspected at

USDA, room 1141, South Building, 14th

Street and Independence Avenue, SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to