(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:

(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 (h) of this section provide the currently acceptable levels of selenium supplementation.

(b) The food additive selenium is a nutrient administered in animal feed as sodium selenite or sodium selenate as provided in paragraph (c) of this section, as a controlled-release sodium selenite bolus as provided in paragraph (f) of this section, as selenium yeast as provided in paragraph (g) of this section, or as selenomethionine hydroxy analogue as provided in paragraph (h) of this section.

(c) Selenium, as sodium selenite or sodium selenate, is added to feed as follows:

(1) In complete feed for chickens, swine, turkeys, sheep, cattle, and ducks at a level not to exceed 0.3 part per million.

(2) In feed supplements for limit feeding as follows:

(i) Sheep: At a level not to exceed an intake of 0.7 milligram per head per day.

(ii) Beef cattle: At a level not to exceed an intake of 3 milligrams per head per day.

(3) In salt-mineral mixtures for free-choice feeding as follows:

(i) Sheep: Up to 90 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 0.7 milligram per head per day.

(ii) Beef cattle: Up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(4) The additive, as sodium selenite or sodium selenate, shall be incorporated into feed as follows:

(i) It shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(ii) It shall be incorporated into each ton of salt-mineral mixture for sheep or beef cattle from a premix containing no more than 4.5 grams of added selenium per pound.

(5) Usage of the additive must conform to the requirements of paragraphs (d) and (e) of this section.

(d) The premix manufacturer shall follow good manufacturing practices in the production of selenium premixes. Inventory, production, and distribution records must provide a complete and accurate history of product production. Production controls must assure products to be what they are purported and labeled. Production controls shall include analysis sufficient to adequately monitor quality.

(e) The label or labeling of any selenium premix shall bear adequate directions and cautions for use including this statement: “Caution: Follow label directions. The addition to feed of higher levels of this premix containing selenium is not permitted.”

(f) The additive is orally administered to beef and dairy cattle as an osmotically controlled, constant release bolus containing sodium selenite. Each bolus contains 360 milligrams of selenium as sodium selenite, and delivers 3 milligrams of selenium per day for 120 days. To ensure safe use of the additive:

(1) The osmotically controlled, constant release bolus is for use only in beef and dairy cattle more than 3 months of age or over 200 pounds body weight.

(2) Only one bolus containing 360 milligrams of selenium as sodium selenite is administered orally to each animal in 120 days.

(3) The labeling shall bear the following: “This bolus delivers the maximum daily allowable amount of selenium and shall be the sole source of supplementation. Do not use in areas containing excess selenium. Do not rebolus within 4 months.”

(g) Selenium yeast is a dried, non-viable yeast (Saccharomyces cerevisiae) cultivated in a fed-batch fermentation which provides incremental amounts of cane molasses and selenium salts in a manner which minimizes the detrimental effects of selenium salts on the growth rate of the yeast and allows for optimal incorporation of inorganic selenium into cellular organic material. Residual inorganic selenium is eliminated in a rigorous washing process and must not exceed 2 percent of the total selenium content in the final selenium yeast product.

(1) Selenium, as selenium yeast, is added to feed as follows:

(i) In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 part per million.

(ii) In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of 3 milligrams per head per day.

(iii) In salt-mineral mixtures for free-choice feeding for beef cattle up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(2) Guaranteed organic selenium content from selenium yeast must be declared on the selenium yeast product label.

(3) The additive, as selenium yeast, shall be incorporated into feed as follows:

(i) It shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(ii) It shall be incorporated into each ton of salt-mineral mixture for beef cattle from a premix containing no more than 4.5 grams of added selenium per pound.

(4) Usage of this additive must conform to the requirements of paragraphs (d) and (e) of this section.

(h) Selenomethionine hydroxy analogue [R,S-2-hydroxy-4-methylselenobutanoic acid (CAS 873660-49-2)] is manufactured by the reaction of elemental selenium with methyllithium to form a methylseleno salt, which is then reacted with R,S-2-hydroxybutyrolactone to form a salt of 2-hydroxy-4-methylselenobutanoic acid. After acidification and purification, the additive consists of not less than 39.5 percent total selenium by weight with a selenomethionine hydroxy analogue content of not less than 98 percent of total selenium. The total organic selenium content of the additive is not less than 99 percent of total selenium.

(1) The selenomethionine hydroxy analogue meets the following specifications:

(i) Arsenic, not more than 2 parts per million (ppm);

(ii) Cadmium, not more than 1 ppm;

(iii) Lead, not more than 1 ppm; and

(iv) Mercury, not more than 1 ppm.

(2) Selenium, as selenomethionine hydroxy analogue, is added to feed as follows:

(i) In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 ppm.

(ii) In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of 3 milligrams per head per day.

(iii) In salt-mineral mixtures for free-choice feeding for beef cattle up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(3) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling of selenomethionine hydroxy analogue in its packaged form shall contain:

(i) The name, selenomethionine hydroxy analogue;

(ii) Minimum and maximum guarantees for a total selenium content of not less than 2.08 percent (weight/weight) and not more than 2.24 percent;

(iii) Minimum guarantee for selenomethionine hydroxy analogue content of not less than 5.2 percent;

(iv) The following statement, “Storage Conditions: Selenomethionine hydroxy analogue must be stored in a closed package at temperatures not higher than 20 °C (68 °F).”; and

(v) An expiration date not to exceed 1 year from the date of manufacture.

(4) The additive, as selenomethionine hydroxy analogue, shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(5) Usage of this additive must conform to the requirements of paragraphs (d) and (e) of this section.