[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
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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