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Gentamicin; Receipt of Application for Emergency Exemption, Solicitation of Public Comment

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 
[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18750-18752]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap06-65]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0234; FRL-7770-1]
 
Gentamicin; Receipt of Application for Emergency Exemption, 
Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the 
Michigan Department of Agriculture to use the pesticide gentamicin(CAS 
No. 1403-66-3) to treat up to 26,600 acres of apples to control 
streptomycin-resistant fire blight. The Applicant proposes the use of a 
new chemical which has not been registered by EPA. EPA is soliciting 
public comment before making the decision whether or not to grant the 
exemption.

DATES: Comments must be received on or before April 27, 2006.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0234, by one of the followingmethods:

[[Page 18751]]

    ? http://www.regulations.gov/. Exit Disclaimer Follow the on-line 
instructions for submitting comments.
    ? Mail: Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., 
Arlington, VA.
     Attention: Docket ID number EPA-HQ-OPP-2006-0234. The docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the docket facility 
is (703) 305-5805. Such deliveries are only accepted during the 
Docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0234. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at http://www.regulations.gov/, Exit Disclaimer including any personal 
information provided, unless the comment includes information claimed to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be captured automatically and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/docket.htm.
     Docket: All documents in the docket are listed in the 
regulation.gov index. Although listed in the index, some information is 
not publicly available, i.e., CBI or other information whose disclosure 
is restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available either electronically at http://
www.regulations.gov/ Exit Disclaimer or in hard copy at the Public Information 
and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
#2, 1801 S. Bell St., Arlington, VA. The docket facility is 
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the docket facility is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 734-9831; fax number: (703) 308-5433; e-mail address: 
ertman.andrew@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    ? Crop production (NAICS code 111)
    ? Animal production (NAICS code 112)
    ? Food manufacturing (NAICS code 311)
    ? Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1.  Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov Exit Disclaimer or e-mail. Clearly mark the part or all 
of the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments, 
remember to:
     i. Identify the document by docket number and other identifying 
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information 
and/or data that you used.
     v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
     vii. Explain your views as clearly as possible, avoiding the use 
of profanity or personal threats.
     viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

 What Action is the Agency Taking?

    Under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the 
Administrator, a Federal or State agency may be exempted from any 
provision of FIFRA if the Administrator determines that emergency 
conditions exist which require the exemption. The Michigan Department 
of Agriculture has requested the Administrator to issue a specific 
exemption for the use of gentamicin on apples to control streptomycin-
resistant fire blight. Information in accordance with 40 CFR part 166 
was submitted as part of this request.

[[Page 18752]]

     As part of this request, the Applicant asserts that gentamicin is 
needed to control streptomycin-resistant strains of Erwinia amylovora, 
the causal pathogen of fire blight due to lack of available 
alternatives and effective alternative control practices. Without the 
use of gentamicin, the applicant states that up to 50% of the yield of 
susceptible apple varieties could be lost in 2006.
    From a public health standpoint, gentamycin is an antibiotic used 
to treat infections cause by many different types of bacteria. At this 
time, gentamycin is not registered for use as a pesticide under FIFRA. 
However, the Agency, along with other public health agencies are 
evaluating appropriate policy approaches for materials used as both an 
antibiotic and a pesticide.
     The Applicant proposes to make no more than three applications of 
a wettable powder formulation of Agry-Gent 10-W that would be used on 
26,600 acres of apples during a use season between April 1, 2006 
through May 31, 2006 in the state of Michigan. If all 26,600 acres are 
treated, 199,500 pounds of product will be used (19,500 pounds of 
active ingredient).
     This notice does not constitute a decision by EPA on the 
application itself. The regulations governing section 18 of FIFRA 
require publication of a notice of receipt of an application for a 
specific exemption proposing use of a new chemical (i.e., an active 
ingredient) which has not been registered by EPA.
    The notice provides an opportunity for public comment on the 
application.
     The Agency, will review and consider all comments received during 
the comment period in determining whether to issue the specific 
exemption requested by the Michigan Department of Agriculture.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 29, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-5396 Filed 4-11-06; 8:45 am]
BILLING CODE 6560-50-S

 
 

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