[Federal Register Volume 71, Number 229 (Wednesday, November 29, 2006)]
[Notices]
[Pages 69114-69116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20150]


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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: [email protected].

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.

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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