August 27, 1997
SELENIUM REGULATIONS FINALIZED
In the August 25, 1997 Federal Register (FR), FDA published a final rule which adopted, without change, the provisions of an interim rule published in the FR of October 17, 1995 (60 FR 53702) regarding the approved use of selenium as a food additive in animal feeds. The current selenium food additive regulation (Title 21, Part 573.920 in the Code of Federal Regulations) provides for the use of sodium selenate or sodium selenite as sources of selenium for selenium supplementation of complete feeds for chickens, swine, turkeys, sheep, cattle, and ducks at a maximum level of 0.3 part per million (ppm); in feed supplements for limit feeding of sheep not to exceed an intake of 0.7 milligram (mg) per head per day and in beef cattle not to exceed an intake of 3 mg per head per day; in salt-mineral mixtures for free-choice feeding for sheep at levels up to 90 ppm at a rate not to exceed an intake of 0.7 mg per head per day and for beef cattle at levels up to 120 ppm at a rate not to exceed an intake of 3 mg per head per day. In addition, an osmotic selenium bolus may also be used as a source of selenium for beef and dairy cattle. The bolus provides 3 mg of selenium per day.
The interim rule on selenium implemented certain provisions of the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of 1994 and the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994. This legislation responded to FDA's stay of the 1987 amendments to the selenium food additive regulation. In 1987, FDA published a food additive amendment which permitted animal feeds for chickens, swine, turkeys, sheep, cattle and ducks to contain supplemental selenium at a level up to 0.3 ppm. In addition, in 1989 FDA approved an osmotic selenium bolus for use in beef and dairy cattle which provided 3 mg of selenium per day. On September 13, 1993, FDA announced that the 1987 and 1989 amendments had been stayed. The Agency took the action to stay those amendments, in part, in response to objections to, and requests for a hearing on or stay of the 1987 amendments and because FDA concluded that the environmental assessment and "finding of no significant impact" for the action were inadequate.
The first legislation passed and signed in 1994 suspended FDA's stay until December 31, 1995. The second legislation states that FDA shall not implement or enforce the stay unless the Commissioner of the FDA finds that selenium supplementation at 0.3 ppm in complete diets is not essential to maintain animal health, is not safe to animals consuming the additive or humans consuming edible portions of selenium-supplemented animals, is not effective to promote normal growth and reproduction, and that the manufacture and use of supplemental selenium cannot be reasonably controlled by adherence to current good manufacturing practice requirements. As a result of these actions and FDA's implementing rule, FDA's stay of the 1987 amendments is no longer in effect.
This final rule will become effective on September 9, 1997. Further information on this final rule is available in the Federal Register or by contacting Dr. Sharon A. Benz, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, telephone 301-594-1724.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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