[Federal Register: November 29, 2006 (Volume 71, Number 229)]
[Notices]
[Page 69114-69116]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no06-45]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2004-0348; FRL-8104-2]
Malathion 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 malathion
and opens a public comment period on this document. The Agency's risk
assessments and other related documents also are available in the
Malathion Docket. Malathion is a non-systemic, broad-spectrum
organophosphate pesticide with numerous commercial agricultural and
residential uses, as well as several wide-area application uses. EPA
has reviewed malathion 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 January 29, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2004-0348, 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
Bldg.), 2777 S. Crystal Dr., 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-
2004-0348. 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 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 telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT: Neil Anderson, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8187; fax
number: (703) 308-8005; e-mail address: anderson.neil@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
[[Page 69115]]
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. EPA
has completed a RED for the pesticide, malathion under section
4(g)(2)(A) of FIFRA. Malathion is a broad-spectrum pesticide used on
numerous commercial agricultural crops. Malathion is registered for
wide-area treatments such as in the United States Department of
Agriculture sponsored Boll Weevil Eradication Program, public health
uses, and fruit fly abatement treatments. Malathion is also registered
for outdoor residential uses on ornamental plants, vegetable gardens,
fruiting trees, and for outdoor structural perimeter treatments.
Malathion is also formulated into a pharmaceutical product (Ovide[reg]
Lotion) which is approved by the Food and Drug Administration for the
control of head lice and their ova. EPA has determined that the
database to support reregistration is substantially complete and that
products containing malathion are eligible for reregistration, provided
the risks are mitigated either in the manner 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) of FIFRA
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) of FIFRA for products containing malathion.
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 malathion tolerances.
Although the Malathion RED was signed on July 31, 2006, certain
components of the document, which did not affect the final regulatory
decision, were undergoing final editing at that time. These components,
including the summary of labeling changes, appendices, and other
relevant information, have been added to the Malathion RED document.
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.
EPA intended to review malathion through the 6-phase process, however,
due to its uses, risks, and other factors, a third public comment
period was added to the 6-phase public participation process for
malathion. Throughout the process, EPA worked extensively with
stakeholders and the public to reach the regulatory decisions for
malathion.
The reregistration program is being conducted under congressionally
mandated timeframes, and EPA recognizes the need both to make timely
decisions and to involve the public. The Agency is issuing the
Malathion 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 malathion. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments.
When providing comment, please provide sufficiently detailed
information to allow the Agency to evaluate your position. For example,
if commenting on a mitigated application rate, or a restricted entry
interval (REI), explain why the mitigated use rate or REI would prove
ineffective, and provide detailed information (such as pest pressure,
pest timing, cultural practices, or the cost and efficacy of the
available alternatives), to support your point.
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.
[[Page 69116]]
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.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: November 16, 2006.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-20150 Filed 11-28-06; 8:45 am]
BILLING CODE 6560-50-S