[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Rules and Regulations]
[Pages 4824-4826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1747]
[[Page 4823]]
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Part VIII
Department of Agriculture
_______________________________________________________________________
Agricultural Marketing Service
_______________________________________________________________________
7 CFR Part 58
Grading and Inspection, General Specifications for Approved Plants;
Final Rule
Federal Register / Vol. 60, No. 15 / Tuesday, January 24, 1995 /
Rules and Regulations
[[Page 4824]]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 58
[DA-93-18]
Grading and Inspection, General Specifications for Approved
Plants and Standards for Grades of Dairy Products; General
Specifications for Dairy Plants Approved for USDA Inspection and
Grading Service
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This document amends the General Specifications for Dairy
Plants Approved for USDA Inspection and Grading Service (General
Specifications), by revising the requirements for anhydrous milkfat to
allow butter to be used as an ingredient and by revising the
requirements for butteroil to allow the addition of safe and suitable
antioxidants. The action to allow the use of butter was initiated at
the request of the American Butter Institute.
EFFECTIVE DATE: January 24, 1995.
FOR FURTHER INFORMATION CONTACT: Duane R. Spomer, Chief, 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 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 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 this final rule
will not have a significant economic impact on a substantial number of
small entities because participation in the USDA-approved plant program
is voluntary and the amendments will not increase the costs to those
utilizing the program.
The Department is issuing this final rule in conformance with
Executive Order 12866.
The General Specifications, established in 1975, do not provide for
butter to be used as an ingredient in anhydrous milkfat. This is
inconsistent with international standards. The General Specifications
also do not provide for the addition of antioxidants to butteroil,
which also is permitted in international standards. These restrictions
place the domestic manufacturer at a disadvantage when competing in the
world market.
In order to enable domestic manufacturers of anhydrous milkfat and
butteroil to compete on equal terms with manufacturers from other
exporting countries and to amend the General Specifications to more
closely align U.S. requirements with international standards, USDA is
amending part 58, subpart B, of the grading and inspection regulations
concerning dairy products, as follows:
1. Provide that butter may be used as an ingredient in anhydrous
milkfat. Currently, the General Specifications permit only cream to be
used as an ingredient in anhydrous milkfat. This is inconsistent with
internationally recognized standards published by the International
Dairy Federation and the Codex Alimentarius Commission that allow the
use of butter in anhydrous milkfat. These amendments more closely align
USDA requirements with internationally recognized standards and allow
butter to be used as an ingredient in anhydrous milkfat.
2. Provide that antioxidants may be added to butteroil. Currently,
the General Specifications do not allow the addition of antioxidants to
butteroil. Internationally recognized dairy standards permit this
addition to assist in preserving the flavor characteristics of this
product. These amendments more closely align USDA requirements with
international standards and allow the addition of antioxidants to
butteroil, provided the antioxidant used is permitted by standards
developed by the Codex Alimentarius Commission and authorized for use
by the Food and Drug Administration (FDA). The Standards developed by
the Commission may be found in the ``Standard A-2 for Milkfat
Products1.'' Antioxidants which are permitted by the Commission
and which may be added to butteroil and the maximum levels allowed are
as follows:
\1\``Standards A-2 for Milkfat Products'', Joint FAO/WHO Food
Standards Program, Codex Committee on Milk and Milk Products. Copies
of the Standard may be obtained from the Dairy Division,
Agricultural Marketing Service, United States Department of
Agriculture, P.O. Box 96456, Washington, DC 20090-6456.
------------------------------------------------------------------------
Antioxidant Maximum level
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Propyl gallate..................... 100 mg/kg.
Butylated hydroxytoluene (BHT)*.... 75 mg/kg.
Butylated hydroxyanisole (BHA)..... 200 mg/kg.
Any combination of propyl 200 mg/kg, but individual limits
gallate, BHA, or BHT*. above not to be exceeded.
Natural and synthetic tocopherols.. 500 mg/kg.
Ascorbyl palmitate; Ascorbyl 500 mg/kg individually or in
stearate. combination.
Dilauryl thiodipropionate.......... 200 mg/kg.
Antioxidant synergists
Citric acid........................ Limit by Good Manufacturing
Practice (GMP).
Sodium citrate..................... Limit by GMP.
Isopropyl citrate mixture; 100 mg/kg individually or in
Phosphoric acid; Monoglyceride combination.
citrate.
------------------------------------------------------------------------
*Temporarily endorsed by the Codex Alimentarius Commission.
FDA provisions relevant to those antioxidants permitted by the
Commission are found in 21 CFR parts 172, 182 or 184. The antioxidants
permitted by FDA are those contained in these regulations. The
antioxidants and levels permitted by FDA are as follows:
------------------------------------------------------------------------
Antioxidant Maximum level
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Propyl gallate................................... 0.02% of fat.
Butylated hydroxytoluene (BHT)................... 0.02% of fat.
Butylated hydroxyanisole (BHA)................... 0.02% of fat.
Tocopherols...................................... Limit by GMP.
Ascorbyl palmitate............................... Limit by GMP.
Dilauryl thiodipropionate........................ 0.02% of fat.
Antioxidant synergists
Citric acid...................................... Limit by GMP.
Sodium citrate................................... Limit by GMP.
Isopropyl citrate................................ 0.02% of food.
Phosphoric acid.................................. Limit by GMP.
Monoglyceride citrate............................ 200 ppm of fat.
------------------------------------------------------------------------
3. Reduce the amount of moisture permitted in anhydrous milkfat.
Currently, the General Specifications allow a maximum moisture content
of 0.15 percent in anhydrous milkfat. International standards developed
by the International Dairy Federation and the Codex Alimentarius
Commission allow a maximum moisture content of 0.1 percent. These
amendments more closely align USDA requirements with international
standards by reducing the maximum allowable moisture content to 0.1
percent. [[Page 4825]]
4. Provide for the pasteurization of oil (highly concentrated
milkfat) in the manufacture of anhydrous milkfat. Pasteurization of
dairy products ensures the destruction of pathogenic organisms.
Currently the General Specifications require that cream be pasteurized
during the production of anhydrous milkfat. In some segments of the
dairy industry, this pasteurization step occurs when the milkfat in the
cream has been concentrated to a level where it is considered to be
``oil'' rather than cream. These amendments still require
pasteurization but allow the manufacturer to pasteurize either cream or
oil.
5. Restrict the amount of other butter constituents in anhydrous
milkfat. When butter is used in anhydrous milkfat, the majority of the
non-milkfat constituents normally found in butter are removed during
manufacture. The non-milkfat constituents removed include protein, ash,
and salt. These amendments limit the amount of non-milkfat constituents
that are permitted to remain in anhydrous milkfat.
Anhydrous milkfat specifications established by USDA are voluntary
specifications that are developed to facilitate the orderly marketing
process. Dairy plants are free to choose whether or not to use the
specifications. When manufactured or processed dairy products are
graded or inspected, the USDA regulations governing the grading or
inspection of dairy products are used.
Public Comments
On July 27, 1994, the Department published a proposed rule (59 FR
38136) to amend the General Specifications for Dairy Plants Approved
for USDA Inspection and Grading Service. The public comment period
closed September 26, 1994. Comments were received from three commenters
representing: One dairy processor trade association, one producer of
anhydrous milkfat and butteroil, and one exporter of dairy products.
Discussion of Comments
1. One commenter was concerned that certain requirements were
inconsistent with international standards. Specifically the USDA
requirement for peroxide value was more stringent, the copper
requirement was less stringent, and the iron and neutralizer
requirements were not specified.
The Department agrees that the Codex Alimentarius requirements for
copper and iron content should be included at the levels permitted by
Codex Alimentarius standards and has made appropriate changes to the
General Specifications.
The peroxide value requirements have been in effect since 1975.
Anhydrous milkfat and butteroil produced in the United States has
consistently met the more stringent peroxide values. These requirements
do not restrict international trade but rather enhance the quality and
stability of U.S. product and its desirability in international trade.
Therefore, no changes in peroxide value are being made at this time.
While International Dairy Federation standards allow for trace
amounts of neutralizer, Codex Alimentarius standards do not. The Codex
Alimentarius standards are the most frequently recognized standards in
major trade agreements. Therefore, no changes in neutralizer content
are being made at this time.
2. One commenter felt that the value of anhydrous milkfat will
decrease because pricing will be based on the butter market rather than
the value of sweet cream.
The General Specifications establish quality requirements and
provide information that facilitates procurement decisions and enhances
trade. The General Specifications do not establish the market value of
this product. If users feel that anhydrous milkfat produced from cream
will better suit their needs, the General Specifications do not inhibit
its availability. Therefore, the changes outlined in the proposed rule
are being made at this time.
3. One commenter felt that the use of butter in anhydrous milkfat
would result in an inferior product and that an increase in related
testing costs would occur.
The anhydrous milkfat quality requirements in the General
Specifications do not differentiate product produced from cream versus
butter. Furthermore, when butter is used to produce anhydrous milkfat,
the General Specifications require that the butter be of either Grade
AA or Grade A quality. When cream is used, the General Specifications
require its flavor to be comparable to the flavor quality specified for
Grade AA or Grade A butter. For these reasons, the Department does not
anticipate that increased testing will result.
4. One commenter opposed the change to allow the pasteurization
step to occur in a more highly concentrated milkfat product (oil).
Pasteurization is essential in ensuring dairy product safety. For
many years, some manufacturers have chosen to pasteurize after the
milkfat has been concentrated to a level considered to be an oil. The
Department believes that pasteurization of the oil is essential in
ensuring product safety and has revised the General Specifications as
outlined in the proposed rule.
5. One commenter requested that the effective date of the changes
occur immediately in order to allow manufacturers to take full
advantage of available export markets.
The Department agrees that these changes enhance the ability of the
U.S. dairy industry to market anhydrous milkfat in the international
markets. Therefore, these changes will be made effective upon
publication.
Pursuant to 5 U.S.C. 533 it is found and determined that good cause
exists for not postponing the effective date of this action until 30
days after publication in the Federal Register. U.S. manufacturers are
prepared to market anhydrous milkfat in the international markets
immediately. Waiting 30 days to make this rule effective would delay
this marketing opportunity. Further, considering the comments received,
no useful purpose would be served in delaying the effective date.
Therefore, this final rule is effective on the date of publication in
the Federal Register.
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, Subpart
B, is amended to read as follows:
PART 58--[AMENDED]
1. The authority citation for 7 CFR Part 58, continues to read as
follows:
Authority: Secs. 202-208, 60 Stat. 1087, as amended; 7 U.S.C.
1621-1627, unless otherwise noted.
2. In Sec. 58.305, paragraphs (b) and (c) are revised to read as
follows:
Sec. 58.305 Meaning of words.
* * * * *
(b) Butteroil. The food product resulting from the removal of
practically all of the moisture and solids-not-fat from butter. It
contains not less than 99.6 percent fat and not more than 0.3 percent
moisture and not more than 0.1 percent other butter constituents, of
which the salt shall be not more than 0.05 percent. Antioxidants
permitted to be used are as follows:
------------------------------------------------------------------------
Antioxidant Maximum level
------------------------------------------------------------------------
Propyl gallate................................... 0.02% of fat.
Butylated hydroxytoluene (BHT)................... 0.02% of fat.
Butylated hydroxyanisole (BHA)................... 0.02% of fat.
Tocopherols...................................... Limit by GMP.
[[Page 4826]]
Ascorbyl palmitate............................... Limit by GMP.
Dilauryl thiodipropionate........................ 0.02% of fat.
Antioxidant synergists
Citric acid...................................... Limit by GMP.
Sodium citrate................................... Limit by GMP.
Isopropyl citrate................................ 0.02% of food.
Phosphoric acid.................................. Limit by GMP.
Monoglyceride citrate............................ 200 ppm of fat.
------------------------------------------------------------------------
An inert gas may be used to flush air-tight containers before, during,
and after filling. Carbon dioxide may not be used for this purpose.
(c) Anhydrous milkfat. The food product resulting from the removal
of practically all of the moisture and solids-not-fat from pasteurized
cream or butter. It contains not less than 99.8 percent fat and not
more than 0.1 percent moisture and, when produced from butter, not more
than 0.1 percent other butter constituents, of which the salt shall be
not more than 0.05 percent. An inert gas may be used to flush air-tight
containers before, during, and after filling. Carbon dioxide may not be
used for this purpose.
* * * * *
3. Section 58.325 is revised to read as follows:
Sec. 58.325 Anhydrous milkfat.
If cream is used in the production of anhydrous milkfat that is
eligible for official certification, the anhydrous milkfat shall be
made by a continuous separation process directly from milk or cream.
The cream used shall be comparable to the flavor quality specified
above for U.S. Grade AA or U.S. Grade A butter. The milkfat from cream
may then be further concentrated into oil. The cream or oil shall be
pasteurized in accordance with the procedures for cream for
buttermaking (Sec. 58.334a). If butter is used in the production of
anhydrous milkfat that is eligible for official certification, the
butter used shall conform to the flavor requirements of U.S. Grade AA
or U.S. Grade A butter and shall have been manufactured in an approved
plant. The appearance of anhydrous milkfat should be fairly smooth and
uniform in consistency.
4. Section 58.347 is revised to read as follows:
Sec. 58.347 Butteroil or anhydrous milkfat.
The flavor shall be bland and free from rancid, oxidized, or other
objectionable flavors.
(a) In addition, the finished products shall meet the following
specifications when sampled and tested in accordance with Secs. 58.336
and 58.337:
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Butteroil Anhydrous milkfat
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Milkfat................... Not less than 99.6 Not less than 99.8
percent. percent.
Moisture.................. Not more than 0.3 Not more than 0.1
percent. percent.
Other butter constituents Not more than 0.1 Not more than 0.1
including salt. percent. percent.
Salt...................... Not more than 0.05 Not more than 0.05
percent. percent.
Antioxidants.............. Those permitted by Those permitted by
standards of the standards of the
Codex Alimentarius Codex Alimentarius
Commission and Commission and
authorized for use authorized for use
by the Food and Drug by the Food and Drug
Administration. Administration.
Free fatty acids.......... Not more than 0.5 Not more than 0.3
percent (calculated percent (calculated
as oleic acid). as oleic acid).
Peroxide value............ Not more than 0.1 Not more than 0.1
milliequivalent per milliequivalent per
kilogram of fat. kilogram of fat.
Iron content.............. Not more than 0.2 ppm Not more than 0.2
ppm.
Copper content............ Not more than 0.05 Not more than 0.05
ppm. ppm.
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Dated: January 18, 1995.
Lon Hatamiya,
Administrator.
[FR Doc. 95-1747 Filed 1-23-95; 8:45 am]
BILLING CODE 3410-02-P
