Registration Review Proposed Decisions: Busan 74 (HPMTS) and Nithiazine

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[EPA-HQ-OPP-2010-0983; FRL-8855-9]

Busan 74 (HPMTS); and Nithiazine; Registration Review Proposed Decisions; Notice of Availability


Environmental Protection Agency (EPA).




This notice announces the availability of EPA's proposed registration review decisions for the pesticides listed in the table in Unit II.A. and opens a public comment period on the proposed decisions. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.


Comments must be received on or before February 22, 2011.


Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit II.A., by one of the following methods:

  • Federal eRulemaking Portal: Follow the on-line instructions for submitting comments.
  • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
  • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit II.A. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at, 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 or e-mail. The Web site 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, your e-mail address will be automatically captured and included as part of the comment that is placed in the 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.

Docket: All documents in the docket are listed in the docket index available at Although, listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at, or, if only available in hard copy, at the 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.

For Further Information Contact

For pesticide-specific information, contact: The Chemical Review Manager for the pesticide of interest identified in the table in Unit II.A.

For general information on the registration review program, contact: Kevin Costello, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5026; fax number: (703) 308-8090; e-mail address:

Supplementary Information

I. General Information

A. Does this action apply to me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager listed underFOR 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 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 ID number and other identifying information (subject heading,Federal Registerdate 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

A. What action is the agency taking?

Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed registration review decisions for the pesticides shown in the following table, and opens a 60-day public comment period on the proposed decisions.

Nithiazine, (case # 7415) is an insecticide belonging to the neonicotinoid class of pesticides, which have been synthesized based on the structure of the naturally occurring pesticide nicotine (present in tobacco). Nithiazine was first registered by EPA in 1995. It is registered for use primarily for house fly control in animal housing facilities (especially poultry facilities; also feed lots, dairy barns, loafing sheds, and stables), and in industrial and other locations (such as garbage chutes, dumpsters, loading docks, grease pits, rest areas, and outdoor restrooms).

Busan 74 (HPMTS) (case # 3033) was first registered in the United States in 1968 and a Reregistration Eligibility Decision (RED) for Busan 74 (HPMTS) was issued in 1995. There are currently no registered end-use products for HPMTS. There is one registered manufacturing use product (MUP) (EPA Reg. No.1448-31) that contains HPMTS as the active ingredient. The MUP is for formulating use only and the labeling prohibits the product's sale, distribution, or use.

Table—Registration Review Proposed Final Decisions
Registration review case name and numberPesticide docket ID numberChemical review manager, telephone number,E-mail address, mail code
Nithiazine (Case No. 7415)EPA-HQ-OPP-2008-0847Yan Donovan, (703) 605-0194,, Mail Code: 7508P.
Busan 74 (HPMTS) (Case No. 3053)EPA-HQ-OPP-2010-0241Rebecca von dem Hagen, (703) 305-6785,, Mail Code: 7510P.

The registration review docket for a pesticide includes earlier documents related to the registration review of the case. For example, the review opened with the posting of a Summary Document, containing a Preliminary Work Plan, for public comment. For Nithiazine, a Final Work Plan was posted to the docket following public comment on the initial docket. For Busan 74 (HPMTS), a Preliminary Work Plan was posted to the docket followed by a public comment period. Because no additional data are required and a “no effect” on any federally listed threatened or endangered species determination has been made, the Agency is publishing a combined Final Work Plan and Proposed Final Decision for HPMTS.

The documents in the dockets describe EPA's proposed registration review decisions of the pesticides included in the table in Unit II.A. These proposed registration review decisions are supported by the rationales included in those documents. Following public comment, the Agency will issue final registration review decisions for products containing the pesticides listed in the table in Unit II.A.

The registration review program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, required EPA to establish by regulation procedures for reviewing pesticide registrations, originally with a goal of reviewing each pesticide's registration every 15 years to ensure that a pesticide continues to meet the FIFRA standard for registration. The Agency's final rule to implement this program was issued in August 2006 and became effective in October 2006, and appears at 40 CFR part 155, subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA) was amended and extended in September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007.

The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed decision. All comments should be submitted using the methods inADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in the table in Unit II.A. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

The Agency will carefully consider all comments received by the closing date and will provide a “Response to Comments Memorandum” in the docket. The final registration review decision will explain the effect that any comments had on the decision and provide the Agency's response to significant comments.

Background on the registration review program is provided at: Links to earlier documents related to the registration review of Busan 74 (HPMTS) and Nithiazine are provided at

B. What is the agency's authority for taking this action?

Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide authority for this action.

List of Subjects

Environmental protection, Administrative practice and procedure, Busan 74, Nithiazine, Pesticides and pests.

Dated: December 15, 2010.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2010-32151 Filed 12-21-10; 8:45 am]
Comment Period Closed
Feb 22 2011, at 11:59 PM ET
ID: EPA-HQ-OPP-2010-0983-0001
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Document Information

Date Posted: Dec 22, 2010
RIN: Not Assigned
Federal Register Number: 2010-32151
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