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Sabadilla Alkaloids; Reregistration Eligibility Decision for Low Risk Pesticide; Notice of Availability

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


 
[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Notices]
[Page 24681-24683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap06-73]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0293; FRL-8059-6]
 
Sabadilla Alkaloids; Reregistration Eligibility Decision for Low 
Risk Pesticide; Notice of Availability

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

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SUMMARY: This notice announces the availability of EPA's Reregistration 
Eligibility Decision (RED) for the pesticide sabadilla alkaloids, and 
opens a public comment period on this document, related risk 
assessments, and other support documents. EPA has reviewed the low risk 
pesticide sabadilla alkaloids through a modified, streamlined version 
of the public participation process that the Agency uses to involve the 
public in developing pesticide reregistration and tolerance 
reassessment decisions. Through these programs, EPA is ensuring that 
all pesticides meet current health and safety standards.

DATES: Comments must be received on or before June 26, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0293, by one of the following methods:
    ? Federal eRulemaking Portal: http://www.regulations.gov. Exit Disclaimer 
Follow the on-line instructions for submitting comments.
    ? Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.

[[Page 24682]]

    ? Hand Delivery: OPP Regulatory Public Docket, Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., 
Arlington, VA. Deliveries are only accepted during the Docket'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 telephone number is (703) 
305-5805.
    ? Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall #2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0293. EPA's policy is that all comments received will be included 
in the 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 Federal regulations.gov 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 
regulations.gov, 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. 
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 
in the electronic docket at http://www.regulations.gov, Exit Disclaimer 
or, if only available in hard copy, at the OPP Regulatory Public Docket at 
the location identified under ``Delivery'' and ``Important Note.'' The 
hours of operation for this docket facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Perry, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8024; fax 
number: (703) 308-7070; e-mail address: mark.perry@epa.gov

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, 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 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 
regulations.gov 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 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

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to 
ensure that they meet current scientific and regulatory standards. 
Using a modified, streamlined version of its public participation 
process, EPA has completed a RED for the low risk pesticide, sabadilla 
alkaloids under section 4(g)(2)(A) of FIFRA. Sabadilla alkaloids are 
insecticides used for the control of thrips on citrus, avocados, and 
mangos. Sabadilla alkaloids are obtained from the ground extract of the 
sabadilla plant. Formulations of sabadilla alkaloid pesticides are 
currently available as wettable powder with the active ingredient 
comprising about 0.2% of the active ingredient. EPA has determined that 
the data base to support reregistration is substantially complete and 
that products containing sabadilla alkaloids will be eligible for 
reregistration, provided the risks are mitigated either in the manner

[[Page 24683]]

described in the RED or by another means that achieves equivalent risk 
reduction. Upon submission of any required product specific data under 
section 4(g)(2)(B) and any necessary changes to the registration and 
labeling (either to address any concerns identified in the RED or as a 
result of product specific data), EPA will make a final reregistration 
decision under section 4(g)(2)(C) for products containing sabadilla 
alkaloids.
    EPA must review tolerances and tolerance exemptions that were in 
effect when the Food Quality Protection Act (FQPA) was enacted in 
August 1996, to ensure that these existing pesticide residue limits for 
food and feed commodities meet the safety standard established by the 
new law. Tolerances are considered reassessed once the safety finding 
has been made or a revocation occurs. EPA has reviewed and made the 
requisite safety finding for the sabadilla alkaloids tolerances 
included in this notice.
    Although the sabadilla alkaloids RED was signed on September 27, 
2004, certain components of the document, which did not affect the 
final regulatory decision, were undergoing final editing at that time. 
These components, including the list of additional generic data 
requirements, summary of labeling changes, appendices, and other 
relevant information, have been added to the sabadilla alkaloids RED 
document. In addition, subsequent to signature, EPA identified several 
minor errors and ambiguities in the document. Therefore, for the sake 
of accuracy, the Agency also has included the appropriate error 
corrections, amendments, and clarifications. None of these additions or 
changes alter the conclusions documented in the September 27, 2004 
sabadilla alkaloids RED. All of these changes are described in detail 
in an errata memorandum which is included in the public docket for 
sabadilla alkaloids.
    EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
issues, and degree of public concern associated with each pesticide. 
EPA can expeditiously reach decisions for pesticides like sabadilla 
alkaloids, which pose few risk concerns, have low use, affect few if 
any stakeholders, and require little risk mitigation. Once EPA assesses 
uses and risks for such low risk pesticides, the Agency may go directly 
to a decision and prepare a document summarizing its findings, such as 
the sabadilla alkaloids RED.
    The reregistration program is being conducted under Congressionally 
mandated time frames, and EPA recognizes the need both to make timely 
decisions and to involve the public in finding ways to effectively 
mitigate pesticide risks. Sabadilla alkaloids, however, poses few risks 
that require mitigation. The Agency therefore is issuing the sabadilla 
alkaloids RED, its risk assessments, and related support materials 
simultaneously for public comment. The comment period is intended to 
provide an opportunity for public input and a mechanism for initiating 
any necessary amendments to the RED. All comments should be submitted 
using the methods in ADDRESSES, and must be received by EPA on or 
before the closing date. These comments will become part of the Agency 
docket for sabadilla alkaloids. Comments received after the close of 
the comment period will be marked ``late.'' EPA is not required to 
consider these late comments.
    EPA will carefully consider all comments received by the closing 
date and will provide a Response to Comments Memorandum in the Docket 
and regulations.gov. If any comment significantly affects the document, 
EPA also will publish an amendment to the RED in the Federal Register. 
In the absence of substantive comments requiring changes, the sabadilla 
alkaloids RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission 
of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in product 
specific data on individual end-use products and either reregistering 
products or taking other ``appropriate regulatory action.''
    Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for 
pesticide residues in effect as of August 2, 1996, to determine whether 
the tolerance or exemption meets the requirements of section 408(b)(2) 
or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 20, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E6-6303 Filed 4-25-06; 8:45 am]
BILLING CODE 6560-50-S 

 
 


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