[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