Document ID: EPA-HQ-OPP-2009-0776-0001
Agency: epa
Document Type: Notice
Title: Pesticide Product Registration Approval
Posted Date: 2010-03-10T05:00Z

[Federal Register: March 10, 2010 (Volume 75, Number 46)]
[Notices]               
[Page 11174]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr10-87]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0776; FRL-8802-1]

 
Pesticide Product Registration Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Agency's issuance, pursuant to the 
provisions of section 3(c)(5) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), of a registration for the pesticide 
product Gonacon Immunocontraceptive Vaccine containing an active 
ingredient not included in any previously registered products.

FOR FURTHER INFORMATION CONTACT: Autumn Metzger, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5314; e-mail address: metzger.autumn@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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2009-0776. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The hours of operation of this Docket Facility are 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket Facility telephone number is (703) 305-5805.
    In accordance with section 3(c)(2) of FIFRA, a copy of the approved 
label, the list of data references, the data and other scientific 
information used to support registration, except for material 
specifically protected by section 10 of FIFRA, are also available for 
public inspection. Requests for data must be made in accordance with 
the provisions of the Freedom of Information Act and must be addressed 
to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001. Such requests should: Identify the 
product name and registration number and specify the data or 
information desired.
    A paper copy of the fact sheet, which provides more detail on this 
registration, may be obtained from the National Technical Information 
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Description of New Chemical

    EPA received an application from the U.S. Department of 
Agriculture, Animal and Plant Health Inspection Service (USDA, APHIS), 
Environmental Services Unit 149, 4700 River Road, Riverdale, MD 20737, 
to register the pesticide product, Gonacon Immunocontraceptive Vaccine, 
contraceptive (EPA File Symbol 56228-GN), containing 1.0 milliliter 
doses in pre-packaged syringes at .03% active ingredient. This product 
was not previously registered.

III. Regulatory Conclusions

    The application was approved on September 29, 2009, as Gonacon 
Immunocontraceptive Vaccine (EPA Registration Number 56228-40) for 
contraception of white-tailed deer. The Agency approved the application 
after considering all required data on risks associated with the 
proposed use of Mammalian Gonadotropin Releasing Hormone (GnRH), and 
information on social, economic, and environmental benefits to be 
derived from use. Specifically, the Agency has considered the nature of 
the chemical and its pattern of use, application methods and rates, and 
level and extent of potential exposure. Based on these reviews, the 
Agency concluded the determinations made pursuant to FIFRA section 
3(c)(5) require registration of GnRH.

IV. Missing Data

    Conditional data required for GonaCon consists of:
     OPPTS Harmonized Test Guideline 830.1700--Validating the 
method of analysis of the formulation and additional preliminary 
analysis.
     OPPTS Harmonized Test Guideline 830.1750--Certified 
Limits.

V. Response to Comments

    EPA published a notice of receipt in the Federal Register of May 1, 
2009 (74 FR 20298) (FRL-8404-9), which announced that the U.S. 
Department of Agriculture, Animal and Plant Health Inspection Service 
(USDA, APHIS), Environmental Services Unit 149, 4700 River Road, 
Riverdale, MD 20737, had submitted an application to register the 
pesticide product, Gonacon Immunocontraceptive Vaccine contraceptive. 
During the public comment period for this active ingredient one comment 
was received from a private citizen who did not oppose the 
manufacturing or selling of this product, but rather the hunting of 
animals, therefore no response was necessary.

List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: March 1, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 2010-5133 Filed 3-9-10; 8:45 am]
BILLING CODE 6560-50-S