Document ID: EPA-HQ-OPP-2007-0202-0012
Agency: epa
Document Type: Notice
Title: Urea Sulfate Registration Review; Draft Ecological Risk Assessment; Notice of Availability
Posted Date: 2009-10-16T04:00Z

[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]               
[Page 53230-53232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-54]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0202; FRL-8793-2]

 
Urea Sulfate Registration Review; Draft Ecological Risk 
Assessment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft 
ecological risk assessment for the registration review of urea sulfate 
and opens a public comment period on this document. Registration review 
is EPA's periodic review of pesticide registrations to ensure that each 
pesticide continues to satisfy the statutory standard for registration, 
that is, the pesticide can perform its intended function without 
unreasonable adverse effects on human health or the environment. As 
part of the registration review process, the Agency has completed a 
comprehensive draft ecological risk assessment for urea sulfate uses, 
including a determination that urea sulfate uses will have no effect on 
federally listed threatened or endangered species or their designated 
critical habitat. After reviewing comments received during the public 
comment period, EPA will issue a revised risk assessment, explain any 
changes to the draft risk assessment, and respond to comments and may 
request public input on risk mitigation before completing a proposed 
registration review decision for urea sulfate. Through this program, 
EPA is ensuring that each pesticide's registration is based on current 
scientific and other knowledge, including its effects on human health 
and the environment.

DATES: Comments must be received on or before December 15, 2009.

ADDRESSES: Submit your comments identified by the docket identification 
(ID) number EPA-HQ-OPP-2007-0202, 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 Facility'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 Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to the docket ID number EPA-HQ-
OPP-2007-0202. 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 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 
available at http://www.regulations.gov. 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 Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  For pesticide specific information 
contact: Andrea Carone, Chemical Review Manager, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0122; fax 
number: (703) 308-8090; e-mail address: carone.andrea@epa.gov.
     For general questions on the registration review program, contact: 
Kevin Costello, Pesticide Re-evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5026; 
fax number: (703) 308-8090; e-mail address: costello.kevin@epa.gov.
     For general questions on OPP's Endangered Species Protection 
Program, contact: Arty Williams, Environmental Fate and Effects 
Division (7507P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7695; fax number: (703) 308-4776; e-
mail address: williams.arty@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, farm worker, 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 chemical review manager 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

[[Page 53231]]

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.
    3. Environmental justice. EPA seeks to achieve environmental 
justice, the fair treatment and meaningful involvement of any group, 
including minority and/or low income populations, 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 or disproportionately high and adverse human 
health impacts or environmental effects from exposure to the 
pesticide(s) discussed in this document, compared to the general 
population.

II. Authority

     EPA is conducting its registration review of urea sulfate pursuant 
to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) and the Procedural Regulations for Registration Review at 
40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other 
things, that the registrations of pesticides are to be reviewed every 
15 years. Under FIFRA, a pesticide product may be registered or remain 
registered only if it meets the statutory standard for registration 
given in FIFRA section 3(c)(5). When used in accordance with widespread 
and commonly recognized practice, the pesticide product must perform 
its intended function without unreasonable adverse effects on the 
environment; that is, without any unreasonable risk to man or the 
environment, or a human dietary risk from residues that result from the 
use of a pesticide in or on food.

III. Registration Reviews

A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registration for urea sulfate to ensure that it continues to satisfy 
the FIFRA standard for registration-- that is, that urea sulfate can 
still be used without unreasonable adverse effects on human health or 
the environment. Urea sulfate is a herbicide used as a desiccant on 
cotton as a cotton harvest aid/defoliant. EPA has completed a 
comprehensive draft ecological risk assessment, including an endangered 
species assessment, for all urea sulfate uses and is announcing the 
availability of the draft ecological risk assessment.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, 
through this notice of availability, for interested parties to provide 
comments and input concerning the Agency's draft ecological risk 
assessment for urea sulfate. Such comments and input could address, 
among other things, the Agency's risk assessment methodologies and 
assumptions, as applied to the draft risk assessment for the 
registration review of urea sulfate. The Agency will consider all 
comments received during the public comment period and make changes, as 
appropriate, to the draft ecological risk assessment. EPA will then 
issue a revised risk assessment, explain any changes to the draft risk 
assessment, and respond to comments. In the Federal Register notice 
announcing the availability of the revised risk assessment, if the 
revised risk assessment indicates risks of concern, the Agency may 
provide a comment period for the public to submit suggestions for 
mitigating the risk identified in the revised risk assessment before 
developing a proposed registration review decision on urea sulfate. As 
described in detail in the Urea Sulfate Summary Document, see docket ID 
number EPA-HQ-OPP-2007-0202, the Agency believes that the human health 
risk assessments completed prior to registration review are adequate, 
and there are no dietary or occupational risks that exceed the Agency's 
level of concern. Thus, no additional human health data are needed for 
the registration review of urea sulfate.
    1. Other related information. Additional information on urea 
sulfate is available on the Pesticide Registration Review Status 
webpage for this pesticide, http://www.epa.gov/oppsrrd1/registration_
review/urea_sulfate/index.htm. Information on the Agency's 
registration review program and its implementing regulation is 
available at http://www.epa.gov/oppsrrd1/registration_review.
    2. Information submission requirements. Anyone may submit data or 
information in response to this document. To be considered during a 
pesticide's registration review, the submitted data or information must 
meet the following requirements:
     To ensure that EPA will consider data or information 
submitted, interested persons must submit the data or information 
during the comment period. The Agency may, at its discretion, consider 
data or information submitted at a later date.
     The data or information submitted must be presented in a 
legible and useable form. For example, an English translation must 
accompany any material that is not in English and a written transcript 
must accompany any information submitted as an audiographic or 
videographic record. Written material may be submitted in paper or 
electronic form.
     Submitters must clearly identify the source of any 
submitted data or information.
     Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
     As provided in 40 CFR 155.58, the registration review docket for 
each pesticide case will remain publicly accessible through the 
duration of the registration review process; that is, until all actions 
required in the final decision

[[Page 53232]]

on the registration review case have been completed.

List of Subjects

    Environmental protection, Pesticides and pests, Urea sulfate.

    Dated: October 6, 2009.
 Peter Caulkins,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. E9-24812 Filed 10-15-09; 8:45 a.m.]

BILLING CODE 6560-50-S