[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
