[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55839-55842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18705]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0348; FRL-7733-5]


Malathion; Revised Risk Assessments, Notice of Availability, and 
Solicitation of Risk Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's revised human 
health risk assessment and as well as the start of a 60-day comment 
period ecological risk assessment for the organophosphate pesticide 
malathion. A revised human health assessment on malathion was conducted 
to incorporate toxicity data which EPA received after 2000. Since no 
additional ecological data on malathion has been received after 2000, 
EPA's ecological risk characterization has remained unchanged. This 
notice also solicits information or data from stakeholders and 
interested parties to help refine the malathion risk assessment, and 
encourages parties to suggest risk management ideas or proposals to 
address the potential risks which have been identified. EPA is 
developing an Interim Reregistration Eligibility Decision (IRED) for 
malathion through the full, 6-Phase public participation process, which 
in this case includes reissuing the revised risk assessment for an 
additional Phase 5 public comment period. The Agency uses this process 
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 November 22, 2005.

ADDRESSES: Comments, identified by identificaiton (ID) number OPP-2004-
0348, may be submitted electronically, by mail, or through hand 
delivery/courier. Follow the detailed instructions as provided in Unit 
I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Tom Moriarty, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 305-5035; 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 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. How Can I Get Copies of this Document and Other Related Information?

     1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0348. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,

[[Page 55840]]

excluding legal holidays. The docket telephone number is (703) 305-
5805.
     2. Electronic access. You may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, to access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
     1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. 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.
     i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0348. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
     ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0348. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
     iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
     2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0348.
     3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0348. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
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 CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.

[[Page 55841]]

     In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
     1. Explain your views as clearly as possible.
     2. Describe any assumptions that you used.
     3. Provide any technical information and/or data you used that 
support your views.
     4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
     5. Provide specific examples to illustrate your concerns.
     6. Offer alternatives.
     7. Make sure to submit your comments by the comment period 
deadline identified.
     8. To ensure proper receipt by EPA, identify the appropriate 
docket ID number in the subject line on the first page of your 
response. It would also be helpful if you provided the name, date, and 
Federal Registercitation related to your comments.

II. Background

A. What Action is the Agency Taking?

     EPA is making available the Agency's revised human health risk 
assessment, and ecological risk assessment on malathion. Previously 
completed risk assessments were issued for public comment through a 
Federal Register notice published on December 12, 2000 (65 FR 77624) 
(FRL-6756-7), along with EPA's response to comments; and related 
documents for malathion. EPA has updated its human health risk 
assessment since 2000 by incorporating data received since that time. 
However, since no additional ecological data regarding malathion has 
been received since 2000, the ecological risk assessment currently 
being made available is the same assessment completed in 2000. EPA 
developed the risk assessments for malathion as part of its public 
process for making pesticide reregistration eligibility and tolerance 
reassessment decisions. Through these programs, EPA is ensuring that 
pesticides meet current standards under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA).
     Malathion is characterized as a non-systemic, broad spectrum 
organophosphate pesticide with numerous commercial agricultural uses, 
residential uses and, as well as several wide area uses. Malathion's 
wide area applications include use as a public health mosquitocide, use 
to control fruit flies, and use in eradication programs such as the 
U.S. Department of Argriculture's Boll Weevil Eradication Program. 
Malathion is also formulated into a pharmaceutical product 
(Ovide[supreg] Lotion) which is approved by the Food and Drug 
Administration for the control of head lice and their ova.
     EPA's revised human health risk assessment has identified 
potential risks of concern from various uses of malathion, some of 
which are derived mainly from potential exposure to malathion's oxygen 
metabolite, malaoxon. Concerns include potential exposure to malaoxon 
through drinking water, and from drift as a result of wide area 
applications. The Agency also has potential risk concerns for adults 
and children who may be exposed to malathion per se from the home 
fogger use of malathion. EPA has also included an analysis of the 
pharmaceutical use of malathion. The analysis of the pharmaceutical use 
presents the proposed safety findings on malathion as a pharmaceutical 
and a pesticide product from the joint perspective of both the Food and 
Drug Administration and EPA.
     The Agency is interested in receiving information which would help 
refine the identified risks, and information on effective and practical 
measures to mitigate potential risk. Information or data that could 
refine uncertainties, or risk estimates that exceed the Agency's level 
of concern are of particular concern to the Agency. Because EPA notes 
that estimated dietary risks differ significantly between calculations 
made with maximum and typical application parameters, the Agency is 
interested in information on typical use patterns (rates, number of 
applications, or application intervals) for commercial agricultural 
crops. EPA notes that in conducting its occupational assessment, 
exposure data were unavailable for two specific application scenarios, 
(1) power dusters, and (2) plant dipping scenarios, and is requesting 
additional information on either of these application scenarios. In 
addition, information is requested on the feasibility of the levels of 
protection assessed for pesticide handlers, and the maximum restricted 
entry intervals being evaluated, as well as the type of post-
application activities which need to be performed for the scenarios 
assessed. With respect to the estimated risk from wide area treatments, 
EPA notes that additional data on the transformation of malathion to 
malaoxon could potentially refine this portion of the malathion risk 
assessment. Additional toxicity data on malaoxon may also be a help to 
EPA. EPA is also interested in information on typical storage 
conditions, or information on malathion's product life cycle, such as 
how long a product is typically stored before it is used.
     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-6756-7), 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. As 
mentioned earlier, a revised risk assessment on malathion was 
previously published in 2000 during Phase 5 of the 6-Phase process. 
However, due to new data and revised risk characterization, EPA is 
reissuing its current revised risk assessment during a second Phase 5 
public comment period.
     All comments should be submitted using the methods in Unit I. and 
must be received by EPA on or before the closing date. Comments and 
proposals 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.
     After considering comments received, EPA will develop and issue 
the Malathion IRED. The decisions presented in this IRED may be 
supplemented by further risk mitigation measures when EPA considers its 
cumulative assessment of the organophosphate pesticides.

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

[[Page 55842]]

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 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: September 14, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-18705 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S