[Federal Register Volume 70, Number 101 (Thursday, May 26, 2005)]
[Notices]
[Pages 30441-30443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10576]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0369; FRL-7711-5]


Chloroneb Risk Assessment; Related Document, and Input on Risk 
Management; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's risk 
assessments, and related documents for the fungicide, chloroneb and 
opens a public comment period on these documents. The public is also 
encouraged to suggest risk management ideas or proposals to address the 
risks identified. EPA is developing a Reregistration Eligibility 
Decision (RED) for Chloroneb through a modified, 4-Phase 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, identified by docket identification (ID) number OPP-
2004-0369, must be received on or before July 25, 2005.

ADDRESSES: Comments 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: Wilhelmena Livingston, Special Review 
and Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8025; fax 
number: (703) 308-8041; 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 may also 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-2004-0369. 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, 
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, 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.1. 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 on 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

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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-2004-0369. 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-2004-0369. 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-2004-0369.
    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-2004-0369. 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.
    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 
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and 
environmental fate and effects risk assessments, and related documents 
for chloroneb, a fungicide, and encouraging the public to suggest risk 
management ideas or proposals. Chloroneb is a systemic fungicide 
currently registered for seed treatment uses on beans (including 
cowpeas), cotton, lupine, soybeans, and sugar beets to protect against 
a variety of diseases such as seed rot, damping-off, blights, and other 
seedling diseases. Chloroneb is also registered on golf course and 
ornamental turf grasses and ornamental plants to control blights. EPA 
developed the risk assessments for chloroneb through a modified version 
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).
    The Agency cannot determine a safety finding for chloroneb at this 
time, due to numerous data gaps, some of which are deemed key. The 
carcinogenic potential could not be assessed since the 2-year chronic 
toxicity/carcinogenicity rat study is unacceptable and a mouse 
carcinogenicity study was not performed. Chloroneb is classified as 
``Data are Inadequate for an Assessment of Carcinogenic Potential.'' 
Confirmation that the seed treatment constitute food uses requiring 
tolerances and the reevaluation of the database has led to the 
conclusion that numerous toxicology and residue chemistry data are now 
required.
    In addition, there is a concern in residential settings from 
entering previously treated areas with chloroneb such as recreational 
areas, home lawns where children might play or golf courses that could 
lead to exposures for adults. There is also a concern for occupational 
handlers in the following scenarios: The mixer/loader/applicator

[[Page 30443]]

for the turf/woody ornamentals/bedding plants/ferns, the loader/
applicator for the use of wettable powder (WP) formulations in 
commercial seed treatments, the on-farm seed treatments except sugar 
beets, loading/applying liquid for commercial soybean treatment, and 
mixing/loading wettable powder for groundboom application on turf. 
There is also a concern for occupational postapplication exposure 
resulting from entering areas previously treated with chloroneb.
    The Agency estimates that two foliar turf uses exceed the 
endangered species and restricted use levels of concern for freshwater 
aquatic organisms. In addition, because there was some mortality 
observed in the bobwhite quail acute dietary study, risks to endangered 
bird species from foliar turf and ornamental uses cannot be dismissed. 
The risks to reptiles and terrestrial phase amphibians are assessed by 
using birds as a surrogate, so risks to reptiles are assumed to be the 
same as those to birds. No acute or chronic mammal assessments were 
conducted because data were not submitted to the Agency. Consequently, 
OPP is not able to dismiss the risk for this group.
    To adequately protect human health and the environment, it may be 
necessary to change current use and/or application practices. The 
Agency is requesting the public's input on usage information, data 
refinement, and/or mitigation proposals to address risk concerns 
resulting from the uses of chloroneb. Specific areas in which the 
Agency is requesting public input are provided in a separate document 
available in the chloroneb docket.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessments for chloroneb. Such comments and input could address, for 
example, the availability of additional data to further refine the risk 
assessments, such as worker exposure data, or could address the 
Agency's risk assessment methodologies and assumptions as applied to 
this specific pesticide. In particular, the Agency is seeking any 
available toxicity data on chloroneb relating to cancer. Without such 
data, the Agency believes a safety finding can not be made, nor a 
decision to find chloroneb eligible for reregistration. Through this 
notice, EPA also is providing an opportunity for interested parties to 
provide risk management proposals or otherwise comment on risk 
management.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development, implementation, and 
enforcement of environmental laws, regulations, and policies. To help 
address potential environmental justice issues, the Agency seeks 
information on any groups or segments of the population who, as a 
result of their location, cultural practices, or other factors, may 
have atypical, unusually high exposure to chloroneb, compared to the 
general population.
    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 
the issues, and degree of public concern associated with each 
pesticide. For chloroneb, a modified, 4-Phase process, one comment 
period and ample opportunity for public consultation seems appropriate 
in view of its refined risk assessments, and limited use. However, if 
as a result of comments received during this comment period EPA finds 
that additional issues warranting further discussion are raised, the 
Agency may lengthen the process and include a second comment period, as 
needed.
    All comments should be submitted using the methods in Unit I. of 
the SUPPLEMENTARY INFORMATION, and must be received by EPA on or before 
the closing date. Comments will become part of the Agency Docket for 
chloroneb. Comments received after the close of the comment period will 
be marked ``late.'' EPA is not required to consider these late 
comments.

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 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: May 19, 2005.
Robert C. Mc Nally,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-10576 Filed 5-25-05; 8:45 am]
BILLING CODE 6560-50-S