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

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:

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\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 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........................... ....................

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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 would be the ones proposed to be allowed by 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

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:

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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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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 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.

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Dated: July 22, 1994.

Lon Hatamiya,

Administrator.

[FR Doc. 94-18247 Filed 7-26-94; 8:45 am]

BILLING CODE 3410-02-P