[Title 21 CFR 573.920]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 573 - FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS]
[Subpart B - Food Additive Listing]
[Sec. 573.920 - Selenium.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  573.920
  Sec. 573.920
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
    Food Additive Listing
  


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:
    (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.

[[Page 516]]

    (6) Paragraphs (b) through (g) 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 or in a controlled-release 
sodium selenite bolus, as provided in paragraph (f) of this section.
    (c) It 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.
    (d) The additive shall be incorporated into feed as follows:
    (1) 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.
    (2) 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.
    (e) 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.
    (f) 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.''
    (g) 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.''

[52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, 1987, as amended at 54 
FR 14215, Apr. 10, 1989; 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 
17, 1995]

    Effective Date Note: At 58 FR 47973, Sept. 13, 1993, the amendments 
to Sec. 573.920 that were published at 52 FR 10887, Apr. 6, 1987; 52 FR 
21001, June 4, 1987; and 54 FR 14214, Apr. 10, 1989 were stayed until 
further notice. At 59 FR 45973, Sept. 6, 1994, the stay was confirmed.