[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Notices]
[Pages 47143-47144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17505]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0218; FRL-7369-3]


Pesticide Product Registration; Conditional Approval

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces Agency approval of an application to 
conditionally register the pesticide product Technical Trypsin 
Modulating Oostatic Factor (TMOF) containing a new active ingredient 
not included in any previously registered product pursuant to the 
provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 605-0515; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a 
pesticide manufacturer. Potentially affected entities may include, but 
are not limited to:
     Pesticide manufacturing (NAICS 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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 an official public docket for this 
action under docket identification (ID) number

[[Page 47144]]

OPP-2004-0218. The official public docket consists of the documents 
specifically referenced in this action, any public comments received, 
and other information related to this action. Although a part of the 
official docket, the public docket does not include Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. The official public docket is the collection of 
materials that is available for public viewing at the Public 
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 
2, 1801 South Bell St., Arlington, VA. This docket facility is 
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket 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 available for public 
inspection in the Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal 
Mall 2, Arlington, VA ((703) 305-5805). 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/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Did EPA Conditionally Approve the Application?

    A conditional registration may be granted under section 3(c)(7)(C) 
of FIFRA for a new active ingredient where certain data are lacking, on 
condition that such data are received by the end of the conditional 
registration period and do not meet or exceed the risk criteria set 
forth in 40 CFR 154.7; that use of the pesticide during the conditional 
registration period will not cause unreasonable adverse effects; and 
that use of the pesticide is in the public interest. The Agency has 
considered the available data on the risks associated with the proposed 
use of Trypsin Modulating Oostatic Factor, and information on social, 
economic, and environmental benefits to be derived from such use. 
Specifically, the Agency has considered the nature and its pattern of 
use, application methods and rates, and level and extent of potential 
exposure. Based on these reviews, the Agency was able to make basic 
health and safety determinations which show that use of Trypsin 
Modulating Oostatic Factor during the period of conditional 
registration will not cause any unreasonable adverse effect on the 
environment, and that use of the pesticide is, in the public interest.
    Consistent with section 3(c)(7)(C) of FIFRA, the Agency has 
determined that these conditional registrations are in the public 
interest. Use of the pesticides are of significance to the user 
community, and appropriate labeling, use directions, and other measures 
have been taken to ensure that use of the pesticides will not result in 
unreasonable adverse effects to man and the environment.

III. Conditionally Approved Registrations

    EPA issued a notice, published in the Federal Register of October 
9, 2002 (67 FR 62965) (FRL-7276-7), which announced that Insect 
Biotechnology Inc., 100 Capitola Drive. Suite 307, Durham, NC 27713, 
had submitted an application to conditionally register the pesticide 
product, Technical Trypsin Modulating Oostatic Factor (TMOF), 
insecticide (EPA File Symbol 74411-R), containing Trypsin Modulating 
Oostatic Factor at 100%, an active ingredient not included in any 
previously registered product.
    The application was conditionally approved on May 24, 2004 as 
Technical Trypsin Modulating Oostatic Factor (TMOF) (EPA Registration 
Number 74411-1).
    The product is registered as a manufacturing use product for 
formulation into insecticides for control of mosquito larvae. As the 
only condition of registration, EPA is requiring the registrant to 
provide a storage stability study by May 24, 2006.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: July 22, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 04-17505 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S