[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.

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

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           
------------------------------------------------------------------------
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    
------------------------------------------------------------------------
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:

------------------------------------------------------------------------
                                  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 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.                
------------------------------------------------------------------------

    Dated: January 18, 1995.
Lon Hatamiya,
Administrator.
[FR Doc. 95-1747 Filed 1-23-95; 8:45 am]
BILLING CODE 3410-02-P