[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12154-12156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5295]
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Proposed Rules
Federal Register
________________________________________________________________________
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.
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Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed
Rules
[[Page 12154]]
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.
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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 [[Page 12155]] 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, Sec. 58.205 (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\1\
\1\Compliance with the standards in this subpart does not excuse
failure to comply with the provisions of the Federal Food, Drug, and
Cosmetic Act.
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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
Milk1
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.
(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 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
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. [[Page 12156]]
(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
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U.S. extra
Flavor characteristics grade
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Chalky................................................... Slight.
Cooked................................................... Slight.
Feed..................................................... Slight.
Flat..................................................... Slight.
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Table II.--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.--Classification According to Laboratory Analysis
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U.S. extra
Laboratory tests 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 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.
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.
(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