Document ID: EPA-HQ-OPP-2007-0202-0015
Agency: epa
Document Type: Notice
Title: Registration Review Proposed Decisions; Availability: Propionic Acid and Salts, and Urea Sulfate
Posted Date: 2010-08-18T04:00Z

[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]               
[Page 51055-51057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-97]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0650; FRL-8840-5]

 
Propionic Acid and Salts, and Urea Sulfate; Registration Review 
Proposed Decisions; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed 
registration review decisions for the pesticides propionic acid and 
salts, and urea sulfate and opens a public comment period on the 
proposed decisions. 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, that the 
pesticide can perform its intended function without unreasonable 
adverse effects on human health or the environment. 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 October 18, 2010.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the specific pesticide of

[[Page 51056]]

interest provided in the table in Unit II.A., 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 identification 
(ID) number listed in the table in Unit II.A. for the pesticide you are 
commenting on. 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: The chemical review manager identified in the table in Unit 
II.A. for the pesticide of interest.
    For general information 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.

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 that is identified in the table in 
Unit II.A. for the pesticide of interest.

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?

    Pursuant to 40 CFR 155.58, this notice announces the availability 
of EPA's proposed registration review decision for the pesticides shown 
in the following table, and opens a 60-day public comment period on the 
proposed decisions. The active ingredient propionic acid is a fungicide 
and bactericide that is used to control fungi and bacteria in stored 
hay and grains, inhibit bacterial growth in drinking water for 
livestock and poultry, control mold and fungi in poultry litter and 
animal feed, and sanitize pre-cleaned food contact surfaces. Propionic 
acid is also used as an inert ingredient in pesticide formulations. 
Propionic acid and its salts, sodium and calcium propionates, are 
approved by the Food and Drug Administration (FDA) in the United States 
as Generally Recognized As Safe (GRAS) for use in food. Propionic acid 
and salts, are exempt from the requirement of a tolerance. Urea sulfate 
is used as a desiccant on

[[Page 51057]]

cotton. No food crop uses remain and all tolerances for urea sulfate 
have been deleted.

                 Registration Review Proposed Decisions
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                                                       Chemical Review
 Registration Review Case Name    Pesticide Docket    Manager,Telephone
           and Number                 ID Number         Number, E-mail
                                                           Address
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Propionic Acid and Salts         EPA-HQ-OPP-2008-00  Wilhelmena
Case Number 4078...............   24                  Livingston
                                                     (703) 308-8025
                                                     livingston.wilhelme
                                                      na@epa.gov
------------------------------------------------------------------------
Urea Sulfate                     EPA-HQ-OPP-2007-02  Andrea Carone
Case Number 7213...............   02                 (703) 308-0122
                                                     carone.andrea@epa.g
                                                      ov
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    The registration review docket for a pesticide includes earlier 
documents related to the registration review of the case. For example, 
the review opened with the posting of a Summary Document, containing a 
Preliminary Work Plan, for public comment. A Final Work Plan was posted 
to the docket following public comment on the initial documents.
     For propionic acid and salts, an endangered species assessment was 
conducted for all uses of propionic acid; however, the Agency 
determined that a health risk assessment was not needed. In addition, 
no data were required at this time to support registrations containing 
propionic acid and salts. The Agency has considered propionic acid and 
salts in light of the standard for registration and safety factors in 
FIFRA and FFDCA, as amended by FQPA. EPA has found that there are not 
likely to be any unreasonable adverse effects to the U.S. population in 
general, and to infants and children in particular, or to non-target 
organisms or the environment from the use of registered pesticide 
products containing propionic acid and salts when currently required 
label instructions are followed. In addition, the Agency has made a 
``No Effect'' determination for endangered species for propionic acid 
and salts. This proposed registration review decision is described in 
more detail in the Propionic Acid and Salts Proposed Registration 
Review Decision, available in the propionic acid and salts docket.
     For urea sulfate, after the publication of the Urea Sulfate Final 
Work Plan, pursuant to section 6(f)(1) of the Federal Insecticide, 
Fungicide, and Rodenticide Act, as amended, the Agency received a 
request to voluntarily cancel all but one registered label for use on 
cotton and then granted the voluntary cancellation request on October 
14, 2008, for all registered use sites besides cotton of urea sulfate 
in the United States. The Agency described the impact of the 
cancellations on the registration review of urea sulfate in the Revised 
Registration Review Ecological Risk Assessment and Effects 
Determination for Urea Sulfate, which was issued on September 3, 2009. 
In this assessment, the Agency made a ``No Effect'' determination for 
federally listed species and designated critical habitats. This 
proposed registration review decision is described in more detail in 
the Urea Sulfate Proposed Registration Review Decision, available in 
the urea sulfate docket.
     Following public comment, the Agency will issue registration 
review decisions for products containing propionic acid and salts, and 
urea sulfate.
    The registration review program is being conducted under 
congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public. Section 3(g) of 
FIFRA, as amended, required EPA to establish by regulation procedures 
for reviewing pesticide registrations, originally with a goal of 
reviewing each pesticide's registration every 15 years to ensure that a 
pesticide continues to meet the FIFRA standard for registration. The 
Agency's final rule to implement this program was issued in August 
2006, and became effective in October 2006, and appears at 40 CFR part 
155 subpart C. The Pesticide Registration Improvement Act of 2003 
(PRIA) was amended and extended in September 2007. FIFRA, as amended by 
PRIA in 2007, requires EPA to complete registration review decisions by 
October 1, 2022, for all pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for 
a minimum 60-day public comment period on all proposed registration 
review decisions. This comment period is intended to provide an 
opportunity for public input and a mechanism for initiating any 
necessary amendments to the proposed decision. 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 
docket for propionic acid and salts. Comments received after the close 
of the comment period will be marked ``late.'' EPA is not required to 
consider these late comments.
    The Agency will carefully consider all comments received by the 
closing date and will provide a ``Response to Comments Memorandum'' in 
the docket. The registration review decision will explain the effect 
that any comments had on the decision and provide the Agency's response 
to significant comments.
     Background on the registration review program is provided at: 
http://www.epa.gov/oppsrrd1/registration_review. A link to earlier 
documents related to the registration review of propionic acid and 
salts, and urea sulfate is provided at: http://www.epa.gov/oppsrrd1/
registration_review/reg_review_status.htm.

B. What is the Agency's Authority for Taking this Action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide 
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, propionic acid and salts, and urea sulfate.

    Dated: August 8, 2010
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.

[FR Doc. 2010-20176 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S