[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