2010-5133. Pesticide Product Registration Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; e-mail address: [e-mail].

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 [phone].

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.