[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]



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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.

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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