[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