[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Rules and Regulations]
[Pages 44892-44894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is adopting without 
change the provisions of an interim rule regarding the approved use of 
selenium as a food additive in animal feeds. The interim rule 
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.

EFFECTIVE DATE: September 9, 1997.
FOR FURTHER INFORMATION CONTACT: Sharon A. Benz, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1724.


[[Page 44893]]


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 (Sec. 573.920 (21 CFR 
573.920)) to increase the maximum amount of selenium supplementation 
permitted in animal feeds. The action was based on 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 that provided for a stay of the 1987 amendments 
to the selenium food additive regulations (hereinafter referred to as 
the 1993 final rule). This action resulted from allegations of 
inadequacies in FDA's finding of no significant impact and in the 
petitioners environmental assessment that supported the 1987 
amendments. 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.

C. Legislative Actions

    The 103d Congress passed two laws (Pub. L. 103-330 and Pub. L. 103-
354) that provided for suspension of FDA's 1993 stay until certain 
conditions were met. As a result, selenium is allowed to 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 part per million (ppm) in complete feeds 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), 
was also available until further notice.

D. 1995 Interim Rule

    In the Federal Register of October 17, 1995 (60 FR 53702), FDA 
published an interim rule that implemented the relevant 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. Under the 
provisions of the Administrative Procedure Act in 5 U.S.C. 553(b)(B) 
and FDA's administrative practices and procedures regulation in 
Sec. 10.40(e) (21 CFR 10.40(e)), the Commissioner of Food and Drugs 
(the Commissioner) found for good cause that prior notice and comment 
on this interim rule was not necessary. The interim rule did not 
involve any exercise of discretion by the Commissioner. It merely 
repeated the terms of Pub. L. 103-354. As provided in FDA's 
administrative practices and procedures regulation at Sec. 10.40(e), 
FDA provided an opportunity for public comment on whether the interim 
rule should be modified or revoked.

II. Summary of Comments

    FDA received three comments in response to the interim rule. Two of 
the three comments were in full agreement with the interim rule. The 
third comment commented on the legislation rather than the interim 
rule. The comment indicated that no one opposed the stated purpose of 
the legislation, ``to permit higher levels of selenium addition to 
feeds to assure proper animal and poultry nutrition.'' This comment 
however objected to what it characterized as the statute's elimination 
of the quality assurance provision of the 1993 final rule that every 
batch of selenium premix be analyzed. Specifically, the comment stated 
that in cases where animals or poultry were killed by consuming feed 
over-fortified with selenium, overfortification of the premix was the 
cause. Therefore, the comment believed that adherence to good 
manufacturing practice alone does not result in appropriate control of 
selenium levels in animal feeds from an animal safety perspective and 
that the statute should have retained a premix batch analysis 
requirement. Because this comment addressed the statute rather than 
FDA's implementation of the statute in the interim rule, no changes 
have been made to this final rule.

III. Analysis of Impacts

    FDA has examined the impact of the final rule under Executive Order 
12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order 
12866 directs agencies to assess all costs and benefits of available 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages, distributive impacts and equity). The agency has reviewed 
this final rule and has determined that the rule is consistent with the 
principles set forth in the Executive Order and these two statutes. 
Furthermore, the final rule is not a significant regulatory action as 
defined by the Executive Order.
    With this rule, FDA is adopting without change the provisions of an 
interim rule published in the Federal Register of October 17, 1995, 
regarding the approved use of selenium as a food additive in animal 
feeds. The interim rule 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 
suspended the 1993 stay of a 1987 food additive approval, which amended 
the selenium food additive regulations to increase the maximum amount 
of selenium supplementation permitted in animal feeds, until certain 
conditions are met.
    By now reaffirming the interim final rule, which merely implemented 
the legislation discussed in section I.D of this document, FDA has not 
imposed any new requirements on industry. The cost of the rule, 
therefore, is zero. The quality assurance provision stayed by the 1993 
final rule, which required every batch of selenium premix to be 
analyzed, was not reinstated by the legislation or the interim final 
rule. The continued elimination of this requirement may result in a 
small cost savings to feed mills and others who were previously 
required to analyze every batch of premix and who will now have the 
option of doing so.
    Under the Regulatory Flexibility Act, unless an agency certifies 
that a rule

[[Page 44894]]

will not have a significant impact on a substantial number of small 
entities, the agency must analyze regulatory options that would 
minimize any significant impact of a rule on small entities. The agency 
can identify at least one company which manufactures quality assurance 
products which are used in the selenium batch testing process. FDA has 
not prohibited the use of these batch testing products. They will still 
be available to feed mills if the feed mills wish to test every batch 
of selenium premix. As this final rule does not impose any new costs on 
this or other firms, under the Regulatory Flexibility Act (5 U.S.C. 
605(b)), the agency certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act requires (in section 202) that 
agencies prepare an assessment of anticipated costs and benefits before 
proposing any expenditure by State, local, and tribal Governments, in 
the aggregate, or by the private sector of $100 million. Because the 
rule does not require any expenditures by industry members or State or 
local governments, FDA is not required to perform a cost/benefit 
analysis under the Unfunded Mandates Reform Act.

IV. Final Action

    The Commissioner has determined that the interim rule published on 
October 17, 1995, should be finalized without modification.

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. Accordingly, the interim rule amending 21 CFR 573.920 that was 
published in the Federal Register of October 17, 1995 (60 FR 53702), is 
adopted as a final rule without change.


    Dated: August 8, 1997.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 97-22476 Filed 8-22-97; 8:45 am]
BILLING CODE 4160-01-F