Document ID: EPA-HQ-OPP-2007-0007-0001
Agency: epa
Document Type: Notice
Title: Monocarbamide Dihydrogen Sulfate (Urea Sulfate); Tolerance Reassessment Decision for Low Risk Pesticide; Notice of Availability
Posted Date: 2007-01-31T05:00Z

[Federal Register: January 31, 2007 (Volume 72, Number 20)]
[Notices]               
[Page 4503-4505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja07-49]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0007; FRL-8112-8]

 
Monocarbamide Dihydrogen Sulfate (Urea Sulfate); Tolerance 
Reassessment Decision for Low Risk Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Tolerance 
Reassessment Decision (TRED) for the pesticide monocarbamide dihydrogen 
sulfate (Urea sulfate), and opens a public comment period on this 
document, related risk assessments, and other support documents. EPA 
has reviewed the low risk pesticide monocarbamide dihydrogen sulfate 
(Urea sulfate) through a modified, streamlined version of the public 
participation process that the Agency uses to involve the public in 
developing pesticide tolerance reassessment and reregistration 
decisions. Through the tolerance reassessment program, EPA is ensuring 
that all pesticides meet current health and food safety standards.

DATES: Comments must be received on or before April 2, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0007, 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 
Building), 2777 S. Crystal Drive, 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-
2007-0007. 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

[[Page 4504]]

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 Building), 2777 S. Crystal Drive, 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: Bentley C. Gregg, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: 703-308-8178; fax number: 
703-308-7070; e-mail address:gregg.bentley@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, 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 Registerdate 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?

    EPA has reassessed the uses of monocarbamide dihydrogen sulfate 
(Urea sulfate); also known as Enquik, reassessed one existing exemption 
from the requirement for a tolerance, and on June 27, 2005, reached a 
tolerance reassessment decision for this low risk pesticide. Urea 
sulfate is used primarily as an active ingredient in herbicides and 
desiccants on agricultural crops. The Agency has determined that urea 
sulfate readily degrades to urea and sulfate ions in the environment 
and in the human body. The Agency is now issuing for comment the 
resulting Report on Food Quality Protection Act (FQPA) Tolerance 
Reassessment Progress and Risk Management Decision for monocarbamide 
dihydrogen sulfate (Urea sulfate), known as a TRED, as well as related 
risk assessments and technical support documents.
    EPA developed the monocarbamide dihydrogen sulfate (Urea sulfate) 
also known as Enquik, TRED through a modified, streamlined version of 
its public process for making tolerance reassessment and reregistration 
eligibility decisions. Through these programs, the Agency is ensuring 
that pesticides meet current standards under the Federal Food, Drug, 
and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended by FQPA. EPA must review tolerances 
and tolerance exemptions that were in effect when the FQPA was enacted, 
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 monocarbamide dihydrogen sulfate (Urea sulfate) 
tolerances included in this notice.
    Although the monocarbamide dihydrogen sulfate (Urea sulfate) TRED 
was signed on June 27, 2005, 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 monocarbamide dihydrogen sulfate (Urea sulfate) TRED 
document. In addition, subsequent to signature, EPA identified several 
minor errors and ambiguities in the document. Therefore, for the sake 
of accuracy, the Agency also has included the appropriate error 
corrections, amendments, and clarifications. None of these additions or 
changes alter the conclusions documented in the June 27, 2005 
monocarbamide dihydrogen sulfate (Urea sulfate) TRED. All of these 
changes are described in detail in an errata memorandum which is 
included in the public docket for monocarbamide dihydrogen sulfate 
(Urea sulfate).
    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 of 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 
issues, and degree of public concern associated with each pesticide. 
EPA can expeditiously reach decisions for pesticides like monocarbamide 
dihydrogen sulfate (Urea sulfate), which pose no risk concerns, affect 
few stakeholders, and require no risk mitigation. Once EPA assesses 
uses and risks for such low risk pesticides, the Agency may go directly 
to a decision and prepare a document summarizing its findings, such as 
the monocarbamide dihydrogen sulfate (Urea sulfate) TRED.

[[Page 4505]]

    The tolerance reassessment program is being conducted under 
Congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public in finding ways to 
effectively mitigate pesticide risks. Monocarbamide dihydrogen sulfate 
(Urea sulfate), however, poses no risks that require mitigation. The 
Agency therefore is issuing the monocarbamide dihydrogen sulfate (Urea 
sulfate) TRED, its risk assessments, and related support documents 
simultaneously for public comment. The comment period is intended to 
provide an opportunity for public input and a mechanism for initiating 
any necessary amendments to the TRED. 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 monocarbamide dihydrogen sulfate (Urea sulfate). Comments 
received after the close of the comment period will be marked ``late.'' 
EPA is not required to consider these late comments.
    EPA 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 TRED in the Federal Register. 
In the absence of substantive comments requiring changes, the decisions 
reflected in the TRED will be implemented as presented.

B. What is the Agency's Authority for Taking this 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 
was to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: January 23, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. E7-1435 Filed 1-30-07; 8:45 am]

BILLING CODE 6560-50-S