Document ID: EPA-HQ-OPP-2007-0379-0029
Agency: epa
Document Type: Notice
Title: Registration Review Proposed Interim Decisions
Posted Date: 2014-12-24T05:00Z

[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77480-77483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30088]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0814; FRL-9919-24]

Registration Review Proposed Interim 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 
interim registration review decisions and opens a public comment. 
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,

[[Page 77481]]

including its effects on human health and the environment.

DATES: Comments must be received on or before February 23, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number for the specific pesticide of interest provided in the 
table in Unit II.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information, 
contact: The Chemical Review Manager for the pesticide of interest 
identified in the table in Unit II.A.
    For general information on the registration review program, 
contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-8015; email address: dumas.richard@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 for the pesticide of interest 
identified in the table in Unit II.A.

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 email. 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 preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability 
of EPA's proposed interim registration review decisions for the 
pesticides shown in the following Table, and opens a 60-day public 
comment period on the proposed interim decisions.

                              Table--Registration Review Proposed Interim Decisions
----------------------------------------------------------------------------------------------------------------
                                                                                       Chemical review manager,
  Registration review case name and              Pesticide docket ID No.               telephone number, email
                 No.                                                                           address
----------------------------------------------------------------------------------------------------------------
Acetic acid and sodium diacetate      EPA-HQ-OPP-2008-0016                           Carolyn Schroeder, (703)
 (Case 4001).                                                                         308-2961,
                                                                                      schroeder.carolyn@epa.gov.
Fosetyl-Al (Case 0646)..............  EPA-HQ-OPP-2007-0379                           Ricardo Jones, (703) 347-
                                                                                      0493,
                                                                                      jones.ricardo@epa.gov.
Picaridin (Case 7433)...............  EPA HQ-OPP-2014-0341                           Ricardo Jones, (703) 347-
                                                                                      0493,
                                                                                      jones.ricardo@epa.gov.
Sodium fluoride (NaF) (Case 3132)...  EPA-HQ-OPP-2014-0655                           SanYvette Williams, (703)
                                                                                      305-7702,
                                                                                      williams.sanyvette@epa.gov
                                                                                      .
Yellow mustard seed (Case 7618) and   EPA-HQ-OPP-2014-0762                           Roy Johnson, (703) 347-
 Sulfonic acid salts (Case 7619).                                                     0492, johnson.roy@epa.gov.
----------------------------------------------------------------------------------------------------------------

    1. Acetic acid and sodium diacetate. Acetic acid (Proposed Interim 
Decision). The registration review docket for acetic acid and sodium 
diacetate (EPA-HQ-OPP-2008-0016) opened in March 2008. Acetic acid and 
sodium diacetate are two different active ingredients: Sodium diacetate 
is a salt of acetic acid. Acetic acid is used as a preservative for 
post harvest stored grains and hay intended for livestock feed. 
Additionally, it is also applied as a non-selective herbicide for 
control of broadleaf weeds and weed grasses. Sodium diacetate is a 
fungicide and bactericide registered to control molds and bacteria. It 
is applied to hay to prevent spoilage and to silage as an aid in 
fermentation. EPA published the Final Work Plan in August 2008. The 
Agency determined that previous human health assessments for acetic 
acid and sodium diacetate were sufficient for registration review and 
no human health risks of concern were identified. The Agency completed 
a comprehensive ecological risk assessment for the nonselective 
herbicide use of acetic acid, including an endangered species 
assessment, and a qualitative ecological risk assessment for sodium 
diacetate. The Agency concludes a ``no effect'' determination for 
acetic acid used as a nonselective herbicide and all currently 
registered uses of sodium diacetate for all non-target organisms; no 
mitigation measures regarding ecological effects are included in the 
proposed interim decision. The risk assessments and proposed interim 
decision for acetic acid and sodium diacetate are currently available 
in the docket for public comment. Acetic acid and sodium diacetate have 
not been evaluated under the EDSP. Therefore, the Agency's final 
registration review decision is dependent upon the results of the 
evaluation of acetic acid and sodium diacetate as potential endocrine 
disruptor risks. Pending the outcome of

[[Page 77482]]

this action, EPA is planning to issue an interim registration review 
decision for acetic acid and sodium diacetate.
    2. Fosetyl-Al. Fosetyl-Al (Proposed Interim Decision). The 
registration review docket for fosetyl-Al (EPA-HQ-OPP-2007-0379) opened 
in December 2007. Fosetyl-Al is systemic fungicide used to control 
diseases caused by oomycetes such as downy mildews. It is registered 
for use on agricultural crops as well as residential and commercial 
areas. EPA published draft human health and ecological risk assessments 
in March 2014. There are no human health risks of concern. The Agency 
also completed an ecological risk assessment. The results of this 
quantitative risk assessment indicates that the currently labeled rates 
of fosestyl-Al pose a potential for adverse effects, i.e., risk, to 
non-target terrestrial animals, including insects, birds, reptiles, 
terrestrial-phase amphibians and mammals. In addition, applications may 
impact sensitive species of dicotyledenous plants (dicots) in 
terrestrial habitats. In order to address potential ecological risks, 
the Agency is proposing changes to product labels which incorporate 
certain risk mitigation measures meant to reduce these risks. These 
measures include restricting aerial application of fosetyl-Al for 
certain uses, reducing the total number of applications that can be 
made annually for certain uses, and clarifying labels to better define 
how fosetyl-Al may be applied. The Agency completed a screening-level 
endangered species assessment and made a ``no effects'' determination 
for the following taxa: Fish, aquatic-phase amphibians, aquatic 
invertebrates, aquatic plants, and monocot plants. For all other 
species the effects determinations are uncertain. Fosetyl-Al has not 
been evaluated under the Endocrine Disruptor Screening Program (EDSP) 
nor has it completed the Endangered Species Act (ESA) Section 7 
consultation with the U.S. Fish and Wildlife Service (Service). 
Therefore, the Agency's final registration review decision is dependent 
upon the result of the evaluation of potential endocrine disruptor risk 
and consultation with the Service for endangered species. Pending the 
outcome of these actions, EPA is planning to issue an interim 
registration review decision for fosetyl-Al.
    3. Picaridin. (Combined Work Plan, Preliminary Risk Assessments, 
and Proposed Interim Decision). The registration review docket for 
Picaridin (EPA HQ-OPP-2014-0341) is opening for public comment on a 
Combined Preliminary Work Plan, Final Work Plan, Preliminary Risk 
Assessments, and Proposed Interim Decision for registration review. Due 
to the lack of need for additional data to support this decision, the 
Agency is also issuing Preliminary Ecological and Human Health Risk 
Assessments for picaridin and opening them for public comment. 
Picaridin is a broad-spectrum insect repellant registered for use 
against biting flies, chiggers, fleas, mosquitos and ticks. Picaridin 
is labelled for use on human skin, clothing, footwear, and on horses. 
EPA has completed comprehensive draft human health and ecological risk 
assessments, including a screening-level endangered species assessment, 
for all picaridin uses. For human health, only residential exposure was 
assessed, and the Agency has not identified any risk concerns 
associated with the registered uses of picaridin. Due to its use on 
human skin and clothing, exposure to terrestrial non-target organisms 
and plants is expected to be inconsequential. Based on the lack of 
potential exposure and nontoxic effects, the ecological risk assessment 
has made a ``no effect'' determination for all federally listed species 
and ``no habitat modification'' of any designated critical habitat for 
listed species. Picaridin has not been evaluated under the EDSP. 
Therefore, the agency's final registration review decision is dependent 
upon the result of the evaluation of potential endocrine disruptor 
risk. Pending the outcome of this action, the Agency is planning to 
issue an interim registration review decision for picaridin.
    4. Sodium fluoride. (Combined Preliminary Work Plan and Proposed 
Interim Decision). The registration review docket for sodium fluoride 
(EPA-HQ-OPP-2014-0655) is opening for public comment on a Combined 
Preliminary Work Plan and Proposed Interim Decision. Sodium fluoride is 
registered for use as a wood preservative to protect the groundline 
portion of existing wooden utility poles. It is formulated as an 
impregnated pole wrap material. This use is not expected to result in 
direct or indirect dietary (food) or drinking water exposure. 
Occupational and residential exposure is minimal by the dermal and 
inhalation routes so no assessment is needed. Based on the lack of 
potential exposure and nontoxic effects to fish, aquatic invertebrates 
and birds, the ecological risk assessment has made a ``no effect'' 
determination for Federally listed species and designated critical 
habitat. Sodium fluoride has not been evaluated under the EDSP. 
Therefore, the agency's final registration review decision is dependent 
upon the result of the evaluation of potential endocrine disruptor 
risk. Pending the outcome of this action, EPA is planning to issue a 
combined preliminary work plan and interim registration review decision 
for sodium fluoride.
    5. Yellow mustard seed/Sulfonic acid salts (Combined Preliminary 
Work Plan and Proposed Interim Decision). The registration review 
docket for yellow mustard seed and sulfonic acid salts is opening for 
public comment on a Combined Preliminary Work Plan and Proposed Interim 
Decision. The registration review docket for Yellow Mustard Seed/
Sulfonic Acid Salts (YMS/SAS) is opening for public comment on a 
combined Work Plan, Draft Risk Assessments, and a Proposed Interim 
Registration Review Decision. This product is a rodenticide for the 
control of the Richardson's ground squirrel and Wyoming ground 
squirrel. YMS/SAS is applied by injection under pressure as a foam into 
burrows inhabited by the pest species in rangeland, ornamental 
plantings, orchards, golf courses, parks, nurseries, and non-crop 
rights-of-way. No risks of concern were identified. YMS/SAS have not 
been evaluated under the EDSP, nor has an endangered species assessment 
been conducted. The Agency's final registration review decision is 
dependent upon the results of both assessments. Pending the outcome of 
those assessments, EPA is issuing an interim registration review 
decision for YMS/SAS.
    The registration review docket for a pesticide includes earlier 
documents related to the registration review of the case. For example, 
the review opened with a Summary Document, containing a Preliminary 
Work Plan, for public comment. A Final Work Plan was placed in the 
docket following public comment on the initial docket. The documents in 
the dockets describe EPA's rationales for conducting additional risk 
assessments, as well as the Agency's subsequent risk findings and 
consideration of possible risk mitigation measures. A proposed 
registration review decision will be supported by the rationales 
included in those documents. Following public comment on a proposed 
decision, the Agency will issue an interim registration review 
decision.
    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 the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 
136a(g)) required EPA to establish by regulation procedures for

[[Page 77483]]

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 interim 
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 interim 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 the pesticides included in the table in 
Unit II.A. 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 as appropriate. The final registration review decision will 
explain the effect that any comments had on the decision.
    Background on the registration review program is provided at: 
http://www2.epa.gov/pesticide-reevaluation. Information regarding 
earlier documents related to the registration review of these 
pesticides can be found at: http://www2.epa.gov/pesticide-reevaluation/individual-pesticides-registration-review.

    Authority: 7 U.S.C. 136 et seq.

    Dated: December 17, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-30088 Filed 12-23-14; 8:45 am]
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