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gentamicin-sulfate Withdrawal of Tolerance Petition 9/99


[Federal Register: October 6, 1999 (Volume 64, Number 193)]
[Page 54304-54305]
>From the Federal Register Online via GPO Access []



[PF-667A; FRL-6383-5]

Gentamicin Sulfate; Withdrawal of Tolerance Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Notice.


SUMMARY: The Agency is withdrawing pesticide petition (PP 5F4449) 
because the petitioner, Quimica, c/o Technology Sciences, Inc., 1101 
17th St., NW., Suite 500, Washington, DC 20036, has withdrawn its 
pesticide registration applications and tolerance petition without 
prejudice to future filing for registration of the products containing 
gentamicin sulfate.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Product Manager 21, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, 
telephone number (703) 308-9354, e-mail address:


 I. Does This Action Apply to Me?

     Although this action only applies to the registrant in question, 
it is directed to the public in general. Since various individuals or 
entities may be interested, the Agency has not attempted to describe 
all the specific entities that may be interested in this action. If you 
have any questions regarding this action, please consult the person 
listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

II. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

     1.  Electronically. You may obtain copies of this document and 
certain other available support documents from the EPA Internet Home 
Page at On the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register- Environmental Documents.''
     2. In person. The Agency has established an official record for 

[[Page 54305]]

action under docket control number PF-667. The official record consists 
of the documents specifically referenced in this action and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is 703-305-5805.

III. What Action Is the Agency Taking?

    EPA is announcing that Quimica Agronomica de Mexico S. de R.L. MI. 
(Quimica) has withdrawn its applications to register a bactericide/
fungicide containing gentamicin sulfate, as provided for in section 
3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), as amended by the Food Quality Protection Act of 1996. 
Gentamicin sulfate is an active ingredient not included in any 
previously registered pesticide product. Quimica has also withdrawn its 
pesticide petition (PP 5F4449) requesting the establishment of a 
tolerance for residues of gentamicin sulfate under section 408 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA)

     EPA issued a notice in the Federal Register on August 7, 1996 (61 
FR 41154), which announced Quimica's submission of a pesticide petition 
(PP# 5F4449). This petition requested that EPA amend 40 CFR part 180 by 
establishing a maximum residue limit (aka pesticide tolerance) for the 
fungicide/bactericide gentamicin sulfate in or on pome fruit at 0.1 
     EPA received comments from the American Society for Microbiology 
(ASM) and the Centers for Disease Control (CDC) within the Department 
of Health and Human Services (HHS). EPA held and participated in an 
inter-agency meeting with the Food and Drug Administration (FDA), U. S. 
Department of Agriculture (USDA), and CDC to discuss the use of this 
antibiotic as a pesticide. There was also significant public interest 
in these proceedings. Quimica has since decided to withdraw its 
pesticide registration applications and tolerance petition.

List of Subjects

    Environmental protection.

    Dated: September 23, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 99-25583 Filed 10-5-99; 8:45 am]