[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)] [Rules and Regulations] [Pages 53702-53704] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-25622] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 573 [Docket No. 86F-0060] Food Additives Permitted In Feed and Drinking Water of Animals; Selenium AGENCY: Food and Drug Administration, HHS. ACTION: Interim rule; opportunity for comment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal food additive regulations concerning the approved use of selenium as a food additive to suspend those amendments resulting from promulgation of a September 13, 1993, stay. This suspension conforms to certain provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 1994, and the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994. This interim rule amends the selenium food additive regulation to provide for the conditions set forth in these laws. DATES: This interim regulation is effective October 17, 1995. Submit written comments by January 16, 1996. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1724. SUPPLEMENTARY INFORMATION: I. Background A. 1987 Amendments In the Federal Register of April 6, 1987 (52 FR 10887), and corrected on June 4, 1987 (52 FR 21001), FDA issued a final rule amending the selenium food additive regulation (21 CFR 573.920) to increase the maximum amount of selenium supplementation permitted in animal feeds. The action was based on [[Page 53703]] a food additive petition (FAP 2201) filed by the American Feed Industry Association, Inc. (AFIA), 1701 North Fort Myer Dr., Arlington, VA 22209. In issuing the 1987 amendments FDA determined, based on an environmental impact analysis report submitted by AFIA, that the amended uses would not have a significant impact on the human environment. B. 1993 Stay of 1987 Amendments In the Federal Register of September 13, 1993 (58 FR 47962), FDA published a final rule which provided for a stay of the 1987 amendments to the selenium food additive regulations (hereinafter referred to as the 1993 final rule). The action was taken in part in response to objections to, and requests for a hearing on or a stay of the 1987 amendments by a number of organizations because of alleged inadequacies found in FDA's finding of no significant impact and in the petitioner's environmental assessment. FDA concluded that the finding and the assessment were inadequate and that there was no genuine or substantial issue of fact as to their inadequacy. FDA has also concluded that the information that was available, if accepted as accurate, would not be sufficient to permit an adequate environmental analysis, and that the information that was necessary to do an adequate environmental analysis was unavailable. As a result of the stay of the 1987 amendments, the maximum permitted use levels of selenium in animal feeds returned to those levels permitted before FDA issued the 1987 amendments. FDA also stayed a 1989 amendment (54 FR 14214, April 10, 1989), to the regulation that provided for the use of a bolus for selenium supplementation at the increased levels, because the environmental assessment for the use of the bolus relied on the 1987 environmental analysis. II. Current Status The 103d Congress passed two laws affecting selenium supplementation of animal food. The first, signed on September 30, 1994, was included in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 1994 (Pub. L. 103-330). Specifically, Title VI provided for suspension of the stay published in the 1993 final rule of the 1987 food additive regulation relating to selenium (Sec. 573.920) (21 CFR 573.920)) until December 31, 1995. The second law was signed on October 13, 1994, as a part of the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994 (Pub. L. 103-354). The law, under Subtitle G--Food Safety Section 262, titled ``Conditions For Implementation of Alteration in the Level of Additives Allowed in Animal Diets,'' prohibits the implementation or enforcement of the 1993 final rule that stayed the 1987 amendments unless certain determinations are made by the Commissioner of Food and Drugs. Specifically, the determinations are set out as: (1) Selenium additives are not essential at levels authorized in the absence of such final rule, to maintain animal nutrition and protect animal health; (2) selenium at such levels is not safe to the animals consuming the additive; (3) selenium at such levels is not safe to individuals consuming edible portions of animals that receive the additive; (4) selenium at such levels does not achieve its intended effect of promoting normal growth and reproduction of livestock and poultry; and (5) the manufacture and use of selenium at such levels cannot reasonably be controlled by adherence to current good manufacturing practice requirements. Both laws provide for suspension of FDA's 1993 stay until certain conditions are met. Pub. L. 103-330 provides for a suspension until December 31, 1995, and Pub. L. 103-354 provides for a suspension until certain determinations are made by the Commissioner of Food and Drugs. Therefore, selenium may be administered in animal feed as sodium selenite or sodium selenate in the complete feed for chickens, swine, turkeys, sheep, cattle, and ducks as provided for by the 1987 amendments to Sec. 573.920, until further notice. The published regulation provides for the currently acceptable levels of selenium supplementation of feed; that is, levels not to exceed 0.3 parts per million (ppm) in feed supplementation of chickens, swine, turkeys, sheep, cattle, and ducks; in feed supplements for sheep not to exceed 0.7 milligram (mg) per head per day and in beef cattle not to exceed 3 mg per head per day; and in free-choice salt-mineral mixes for sheep up to 90 ppm but not to exceed 0.7 mg per head per day and for beef cattle up to 120 ppm in a mixture for free-choice feeding not to exceed an intake of 3 mg per head per day. In addition, the orally administered, osmotically controlled, and constant release bolus for beef and dairy cattle provided for on April 10, 1989 (54 FR 14214), is also available until further notice. III. Authority for This Regulation Under the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(B) and FDA's administrative practices and procedures regulation at 21 CFR 10.40(e), the Commissioner finds for good cause that prior notice and comment on this interim rule are unnecessary. The rule does not involve any exercise of discretion by the Commissioner. It merely repeats the terms of Pub. L. 103-354. As provided in FDA's administrative practices and procedures regulation at 21 CFR 10.40(e), FDA is providing an opportunity for public comment on whether the interim rule should be modified or revoked. IV. Request for Comments Interested persons may, on or before January 16, 1996, submit to the Dockets Management Branch (address above) written comments regarding this interim rule. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows: PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 1. The authority citation for 21 CFR part 573 continues to read as follows: Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348). 2. Section 573.920 is amended by redesignating the introductory text and paragraphs (a) through (f) as paragraphs (a) through (g) respectively, and by revising newly redesignated paragraph (a) to read as follows: Sec. 573.920 Selenium. (a) Public Law 103-354 enacted October 13, 1994 (the 1994 Act), states that FDA shall not implement or enforce the final rule issued on September 13, 1993 (58 FR 47962), in which FDA stayed the 1987 amendments and any modification of such rule issued after enactment of the 1994 Act; unless the Commissioner of Food and Drugs makes a determination that: [[Page 53704]] (1) Selenium additives are not essential at levels authorized in the absence of such final rule, to maintain animal nutrition and protect animal health; (2) selenium at such levels is not safe to the animals consuming the additive; (3) selenium at such levels is not safe to individuals consuming edible portions of animals that receive the additive; (4) selenium at such levels does not achieve its intended effect of promoting normal growth and reproduction of livestock and poultry; and (5) the manufacture and use of selenium at such levels cannot reasonably be controlled by adherence to current good manufacturing practice requirements. (6) Paragraphs (b) through (g) of this section provide the currently acceptable levels of selenium supplementation. * * * * * Dated: October 10, 1995. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 95-25622 Filed 10-16-95; 8:45 am] BILLING CODE 4160-01-F