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

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.

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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.

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*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:

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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.

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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:

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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.

[[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.

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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