[Federal Register Volume 59, Number 143 (Wednesday, July 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18247]


[[Page Unknown]]

[Federal Register: July 27, 1994]


                                                   VOL. 59, NO. 143

                                           Wednesday, July 27, 1994

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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend the General Specifications for 
Dairy Plants Approved for USDA Inspection and Grading Service (General 
Specifications). The proposed changes would revise the requirements for 
anhydrous milkfat to allow butter to be used as an ingredient and would 
revise the requirements for butteroil to allow the addition of safe and 
suitable antioxidants. The proposal to allow the use of butter was 
initiated at the request of the American Butter Institute.

DATES: Comments should be filed by September 26, 1994.

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 made 
available for public inspection at the Dairy Division in Room 2750-S 
during regular business hours.

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 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 this proposed rule, 
if promulgated, would 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 would not 
increase the costs to those utilizing the program.
    The Department is issuing this rule in conformance with Executive 
Order 12866.
    The General Specifications, established in 1975, do not provide for 
butter to be used in making anhydrous milkfat in USDA-approved dairy 
plants. This is inconsistent with international standards that allow 
butter to be used in anhydrous milkfat. The General Specifications also 
do not provide for the addition of antioxidants to butteroil, which 
also is permitted in international standards. These restrictions have 
placed the domestic manufacturer at a disadvantage when competing in 
the world market.
    To permit 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 proposing 
changes to Part 58, subpart B, of the grading and inspection 
regulations concerning dairy products, as follows:
    1. Amend Ingredient Requirements to Permit Butter To Be Used as an 
Ingredient in Anhydrous Milkfat
    The General Specifications were established in 1975 and permit only 
cream to be used as an ingredient in anhydrous milkfat. The 
International Dairy Federation and the Codex Alimentarius Commission 
have both developed internationally recognized standards that allow the 
use of butter in making anhydrous milkfat. Revision of the General 
Specifications is being proposed to align USDA requirements with 
internationally recognized standards and allow butter as an ingredient 
in anhydrous milkfat.
    2. Allow the Addition of Antioxidants to Butteroil
    The General Specifications do not provide for the addition of 
antioxidants to butteroil. International dairy standards permit the 
addition of antioxidants to assist in preserving the flavor 
characteristics of this product. Revision of the General Specifications 
is being proposed to align USDA requirements with international 
standards and to 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 
Products.''1 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   
------------------------------------------------------------------------
Propyl gallate....................................   100 mg/kg.         
Butylated hydroxytoluene (BHT)*...................  75 mg/kg.           
Butylated hydroxyanisole (BHA)....................  200 mg/kg.          
  Any combination of propyl gallate, BHA, or BHT*.  200 mg/kg, but      
                                                     individual limits  
                                                     above not to be    
                                                     exceeded.          
Natural and synthetic tocopherols.................  500 mg/kg.          
Ascorbyl palmitate................................  500 mg/kg           
                                                     individually or in 
                                                     combination.       
Ascorbyl stearate.................................  ....................
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 
                                                     combination.       
  Phosphoric acid.................................  ....................
  Monoglyceride 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 would be the ones proposed to be allowed by these 
regulations. The antioxidants and levels permitted by FDA 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.       
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
    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. Revision of the 
General Specifications is being proposed to align USDA requirements 
with international standards by reducing the maximum allowable moisture 
content to 0.1 percent.
    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. The General Specifications require cream to be 
pasteurized in 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. Changes in the General Specifications are 
being proposed to provide for this industry practice.
    5. Restrict the Amount of Other Butter Constituents in Anhydrous 
Milkfat When Butter is used as an Ingredient
    When butter is used in anhydrous milkfat, the majority of the non-
milkfat constituents normally found in butter are removed during the 
manufacture of the product. The non-milkfat constituents which are 
removed include protein, ash, and salt. Changes are being proposed to 
restrict the amount of these non-milkfat constituents that would be 
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.

List of Subjects in 7 CFR Part 58

    Dairy products, Food grades and standards, Food labeling, Reporting 
and record keeping requirements.

    For the reasons set forth in the preamble, it is proposed that 7 
CFR Part 58, Subpart B, be amended to read as follows:

PART 58--[AMENDED]

    1. The authority citation for 7 CFR Part 58, Subpart B, 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 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.       
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.

------------------------------------------------------------------------
                                Butteroil            Anhydrous milkfat  
------------------------------------------------------------------------
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             Not more than 0.1        Not more than 0.1     
 constituents including   percent.                 percent.             
 salt.                                                                  
Salt...................  Not more than 0.05       Not more than 0.05    
                          percent.                 percent.             
Antioxidants...........  Those permitted by       Those permitted by    
                          standards of the Codex   standards of the     
                          Alimentarius             Codex Alimentarius   
                          Commission and           Commission and       
                          authorized for use by    authorized for use by
                          the Food and Drug        the Food and Drug    
                          Administration.          Administration.      
Free fatty acids.......  Not more than 0.5        Not more than 0.3     
                          percent (calculated as   percent (calculated  
                          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.     
Copper content.........  Not more than 0.10 ppm.  Not more than 0.10    
                                                   ppm.                 
------------------------------------------------------------------------

    Dated: July 22, 1994.
Lon Hatamiya,
Administrator.
[FR Doc. 94-18247 Filed 7-26-94; 8:45 am]
BILLING CODE 3410-02-P