[Federal Register Volume 59, Number 4 (Thursday, January 6, 1994)]
[Notices]
[Pages 754-755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-114]


[[Page Unknown]]

[Federal Register: January 6, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93D-0398]

 

Proposed Guideline Regarding Microbiological Testing for 
Antimicrobial Food-Animal Drugs; Availability

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 proposed guideline entitled ``Microbiological Testing 
of Antimicrobial Drug Residues in Food'' prepared by the Center for 
Veterinary Medicine (CVM) regarding the tests required for food-animal 
antimicrobial drug products to establish their human-food safety. This 
proposed guideline provides criteria for determining which 
antimicrobials will require supplemental testing, and recommends test 
procedures that are necessary to ensure that antimicrobial residues 
will not cause intestinal microflora perturbations in the consumer.

DATES: Submit written comments by April 6, 1994.

ADDRESSES: Submit written requests for single copies of the proposed 
guideline to the Communications and Education Branch (HFV-12), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 301-594-1755, or the contact person (address 
below). Send two self-addressed adhesive labels to assist that office 
in processing your requests. Submit written comments on the proposed 
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 proposed 
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: Haydee Fernandez, Center for 
Veterinary Medicine (HFV-154), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1684.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
proposed guideline entitled ``Microbiological Testing of Antimicrobial 
Drug Residues in Food'' regarding required testing for food-animal 
antimicrobial drug products. In evaluating new animal drug applications 
(NADA's) the agency must determine, among other factors, the safety of 
the intended use of the drug, including the cumulative effect on man or 
animal required by section 512(d)(2)(B) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(d)(2)(B)). The proposed 
guideline provides criteria that will be used to determine which 
antimicrobial drugs will require supplemental testing to ensure that 
antimicrobial residues will not cause intestinal microflora 
perturbations in the consumer exposed to antimicrobial residues.
     It is well known that therapeutic doses of antibiotics can cause 
adverse effects on the intestinal microflora ecology. In most cases the 
lowest dose at which these perturbations occur have not been 
determined; however, CVM believes that the ecology of the human 
intestinal microflora should not be disturbed by the residues of 
antimicrobials used in food-animals.
     In June 1992, CVM sponsored a symposium on the Microbiological 
Significance of Drug Residues in Food to evaluate scientific expertise 
in this area. Information discussed at the symposium reaffirmed CVM's 
conclusion that the residue antimicrobial activity is a valid endpoint 
for establishing residue tolerances for antimicrobial animal drugs.
     CVM proposes establishing two categories for antimicrobial drugs: 
(1) ``New Animal Antimicrobial Drugs Requiring Additional Human Food 
Safety Microbiological Testing'' and (2) ``New Animal Antimicrobial 
Drugs Exempt from Additional Human Food Safety Microbiological 
Testing.'' To qualify for exemption from additional microbiological 
testing, the antimicrobial drug must have either: (1) ``Very low'' 
residue levels, (2) residues with limited antimicrobial activity, or 
(3) no adverse effects on intestinal microflora at approved dosages. 
Antimicrobial drugs will require additional testing in cases where a 
safe residue concentration retains antimicrobial activity in humans at 
residue exposure levels greater than 1 part per million in the total 
diet.
     CVM requests comments regarding how the proposed guideline should 
relate the effects of low doses of antibiotics observed in model 
systems to potential adverse biological effects in humans. In addition, 
information is requested on the appropriate endpoints for monitoring 
the effects of the different classes of antibiotics.
     Interested persons may, on or before April 6, 1994, submit to the 
Dockets Management Branch (address above) written comments on the 
proposed guideline. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The proposed guideline and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 28, 1993.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 94-114 Filed 1-5-94; 8:45 am]
BILLING CODE 4160-01-F