[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21835]
[[Page Unknown]]
[Federal Register: September 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 558 and 573
[Docket No. 86F-0060]
Food Additives Permitted in Feed and Drinking Water of Animals;
Selenium; Stay of the 1987 Amendments; Reassessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is confirming the
continued validity of the stay of the 1987 amendments to the selenium
food additive regulations. The amendments provided for an increase in
the maximum supplementation level of selenium in animal feeds. On
September 13, 1993 (58 FR 47962), the Food and Drug Administration
(FDA) stayed the 1987 amendments to the selenium food additive
regulations. In that document the agency stated that it intended to
reassess the decision to stay the amendment of the regulation, based on
the progress of the needed research on selenium, by September 13, 1994,
and as needed thereafter. The agency has determined that sufficient
progress has been made and is issuing this document to confirm the
continued validity of the stay.
EFFECTIVE DATE: September 6, 1994.
ADDRESSES: Submit written information to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. The public file may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Woodrow M. Knight, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1731.
SUPPLEMENTARY INFORMATION:
I. Background
On September 13, 1993 (58 FR 47962), FDA stayed the 1987 amendments
to the selenium food additive regulations. As a result of the stay of
the 1987 amendments, the maximum permitted use levels of selenium
returned to those levels permitted before FDA issued the amendments.
FDA also stayed the portion of the regulation that provided for the use
of a bolus for selenium supplementation at the increased levels. This
action was taken because the agency concluded that FDA's finding of no
significant impact and the environmental assessment prepared by the
American Feed Industry Association for the 1987 action were inadequate
to determine whether selenium supplementation of animals results in
wastes that may cause selenium-related environmental impacts.
FDA also stated in the September 13, 1993, final rule that it
intended to reassess its decision to stay the amendments by September
13, 1994, and as needed thereafter. Progress made on the research
required to complete an adequate environmental analysis is to be
evaluated to determine the continued validity of the stay. If the
agency makes the determination that progress is not adequate, the
agency is to take action to deny the petition and revoke the 1987
amendments.
For that reason, the agency asked to be kept advised of all
research endeavors.
II. Confirmation of the Stay
The agency has determined that sufficient progress is being made to
confirm the continued validity of the stay after September 13, 1994.
The basis for this determination is the progress made at the Selenium
Environmental Roundtable, which was held by the Forum for Animal
Agriculture on January 25 and 26, 1994. The final report of the
Roundtable assists in prioritizing the research needed (Environmental
Roundtable: Selenium Use in Animal Feeds, Final Report, January 25 and
26, 1994, Forum for Animal Agriculture). A copy of this report under
the same docket number 86F-0060 is on display at the Dockets Management
Branch (address above). Further, the agency has been advised of
independent research initiatives at Michigan State University,
University of Kentucky, University of Idaho, and Texas A & M
University.
FDA should continue to be kept apprised of all research endeavors.
Comments should be submitted to the Dockets Management Branch (address
above) and identified with the docket no. 86F-0060. The agency will
conduct periodic reassessments of research progress as needed after
September 13, 1994. If the agency determines, based on the
reassessments, that research progress is not adequate, the agency will
take the actions necessary to deny the 1986 food additive petition and
revoke the 1987 amendments.
Dated: August 24, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-21835 Filed 9-2-94; 8:45 am]
BILLING CODE 4160-01-F
