[Federal Register Volume 59, Number 120 (Thursday, June 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15249]


[[Page Unknown]]

[Federal Register: June 23, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0147]

 

Utility Studies for Anti-Salmonella Chemical Food Additives in 
Animal Feeds; Draft Guideline Availability; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guideline entitled ``Utility Studies for Anti-
Salmonella Chemical Food Additives in Animal Feeds'' prepared by the 
Center for Veterinary Medicine (CVM). The agency is formulating a 
guideline to provide guidance on the testing of food additives that are 
intended to control Salmonella contamination of animal feeds. Following 
the comment period CVM intends to finalize the guideline. CVM is also 
announcing a public workshop on this guideline. Received comments will 
be considered to determine if further revision of the guideline is 
necessary.

DATES: The public workshop will be held on Monday, August 8, 1994, from 
7:45 a.m. to 12 m. Submit written notices of participation by July 15, 
1994. Submit written comments on the draft guideline by October 21, 
1994.

ADDRESSES: The public workshop will be held at the Mississippi State 
University at Starkville, MS, in McCool Hall, rm. 217. Submit written 
notices of participation to the contact person listed below. Submit 
requests for single copies of the draft guideline to the Communications 
and Education Branch (HFV-12), Center For Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two 
self-addressed adhesive labels to assist that office in processing your 
requests. Submit written comments on the draft guideline to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the draft guideline and received comments 
are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Henry E. Ekperigin, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1731.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guideline entitled ``Utility Studies for Anti-Salmonella Chemical 
Food Additives in Animal Feeds.'' This draft guideline may be used by 
the sponsors of proposed food additive petitions to prepare study 
protocols necessary for determining the ability of antimicrobial food 
additives to achieve their intended technical effect of controlling 
Salmonella contamination in animal feeds.
    In 1990, CVM established a policy of zero Salmonella in animal 
feeds. This policy has resulted in the development of several products 
for use in helping to achieve zero salmonella. These products, in their 
current unapproved status, are considered by FDA to be unsafe food 
additives because they are not generally recognized as safe for use to 
control Salmonella contamination and because none is the subject of a 
food additive regulation permitting its use for this intended use.
    CVM is providing this information to help guide sponsors in 
designing studies that can demonstrate utility and become part of a 
food additive petition. The information will also help guide the 
consistent evaluation of these petitions. During the comment period, 
CVM will hold a workshop to discuss the draft guidance. The workshop 
will be held in conjunction with the 1994 annual meeting of the Poultry 
Science Association.
    Guidelines state practices or procedures that may be useful but are 
not legal requirements. The guideline represents the agency's position 
at the time of its issuance. A person may follow the guideline or may 
choose to follow alternate practices or procedures. If a person chooses 
to use alternate practices or procedures, that person may wish to 
discuss the matter further with the agency to prevent an expenditure of 
money and effort on activities that might later be determined to be 
unacceptable. The guideline does not bind the agency, and it does not 
create or confer any rights, privileges, immunities, or benefits for or 
on any person. When a guideline states a requirement imposed by statute 
or regulation, however, the requirement is law and its force and effect 
are not changed in any way by virtue of its inclusion in the guideline.
    Interested persons may, on or before October 21, 1994, submit 
written comments on the draft guideline to the Dockets Management 
Branch (address above). FDA will consider these comments in finalizing 
the guideline. Comments should be submitted in duplicate (except that 
individuals may submit one copy), identified with the docket number 
found in brackets in the heading of this document. The guideline and 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 17, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-15249 Filed 6-22-94; 8:45 am]
BILLING CODE 4160-01-F