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Piperonyl Butoxide (PBO) Reregistration Eligibility Decision; Notice of Availability
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Notices]
[Page 42385-42386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy06-65]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0042; FRL-8066-1]
Piperonyl Butoxide (PBO) Reregistration Eligibility Decision;
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 piperonyl butoxide, and
opens a public comment period on this document. The Agency's risk
assessments and other related documents also are available in the
piperonyl butoxide Docket. Piperonyl butoxide (PBO) is a pesticide
active ingredient that acts as a synergist. Synergists are chemicals
which, while lacking pesticidal properties of their own, enhance the
pesticidal properties of other active ingredients including pyrethrins
and pyrethroids. PBO is used in four general ways: Preharvest and
postharvest uses on many agricultural crops; direct and indirect
treatments of livestock animals and premises; treatments of commercial
and industrial facilities and storage areas where raw and processed
food/feed commodities are stored or processed; and mosquito abatement
areas. EPA has reviewed piperonyl butoxide through 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 October 24, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0042, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov. 
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
Building), 2777 S. Crystal Drive, 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.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0042. 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, 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 website 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
either in the electronic docket at http://www.regulations.gov,
or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Cathryn O'Connell, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number (703) 308-0136; fax number:
(703) 308-7070; e-mail address: oconnell.cathryn@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.
[[Page 42386]]
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. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, piperonyl butoxide under section 4(g)(2)(A) of FIFRA.
Piperonyl butoxide (PBO) is a pesticide active ingredient that acts as
a synergist. Synergists are chemicals which, while lacking pesticidal
properties of their own, enhance the pesticidal properties of other
active ingredients including pyrethrins and pyrethroids. PBO is used in
four general ways: Preharvest and postharvest uses on many agricultural
crops; direct and indirect treatments of livestock animals and
premises; treatments of commercial and industrial facilities and
storage areas where raw and processed food/feed commodities are stored
or processed; and mosquito abatement areas. EPA has determined that the
data base to support reregistration is substantially complete and that
products containing piperonyl butoxide are eligible for reregistration,
provided the risks are mitigated in the manner described in the RED.
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 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 piperonyl butoxide.
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 piperonyl butoxide tolerances.
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, EPA 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.
Due to its uses, risks, and other factors, piperonyl butoxide was
reviewed through the full 6-Phase process. Through this process, EPA
worked extensively with stakeholders and the public to reach the
regulatory decisions for piperonyl butoxide.
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. The Agency is issuing the
piperonyl butoxide RED for public comment. This comment period is
intended to provide an additional 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 piperonyl butoxide. 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 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
piperonyl butoxide RED will be implemented as it is now presented
without further notice.
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: July 13, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-11717 Filed 7-25-06; 8:45 am]
BILLING CODE 6560-50-S