Document ID: EPA-HQ-OPP-2015-0059-0001
Agency: epa
Document Type: Notice
Title: Registration Review Proposed Interim Decisions
Posted Date: 2015-03-25T04:00Z

[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15785-15787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06860]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0059; FRL-9923-76]

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 on certain pesticides and opens a 
public comment period on the proposed interim 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.March 25, 2015

DATES: Comments must be received on or before May 26, 2015.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number for the specific pesticide of interest 
provided in the table in Unit II., 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.
    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) 308-8015; 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.

[[Page 15786]]

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.

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
 Registration review case name   Pesticide Docket    manager, telephone
            and No.                   ID No.         No., email address
------------------------------------------------------------------------
Debacarb (2-EEEBC) (Case 4031)  EPA-HQ-OPP-2008-0  Roy Johnson, 703-347-
                                 802.               0492,
                                                    johnson.roy@epa.gov.
Maleic Hydrazide (Case 0381)..  EPA-HQ-OPP-2009-0  Ricardo Jones, 703-
                                 387.               347-0493,
                                                    jones.ricardo@epa.gov.
Soap Salts (Case 4083)........  EPA-HQ-OPP-2008-0  Eric Miederhoff, 703-
                                 519.               347-8028
                                                    miederhoff.eric@epa.gov.
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    Debacarb (2-EEEBC) (Proposed Interim Decision). Debacarb is a 
fungicide registered for use to control certain diseases in ornamental 
trees. The fungicide is applied to mature trees by injection through 
the trunk. EPA has completed a draft ecological risk assessment, 
including a screening-level listed species assessment. A human health 
risk assessment is not needed because the method of application limits 
the possibility for applicator or other human exposure. Direct adverse 
effects are not expected for birds, reptiles, terrestrial-phase 
amphibians, mammals, and terrestrial plants. The Agency has made a No 
Effects (NE) determination for all federally-listed species within 
these groups and a No Habitat Modification determination for all 
designated critical habitats associated with these species for the 
currently registered uses of debacarb. Risks currently cannot be 
precluded for aquatic receptors and terrestrial invertebrates. At this 
time, to eliminate uncertainty and reduce potential risks to non-listed 
aquatic species, the Agency is proposing restrictions on application to 
trees near waterbodies. To reduce uncertainty and potential risks to 
insect pollinators, the Agency is proposing that applications to trees 
be limited to the post-bloom period. This proposed interim decision 
does not cover the Endocrine Disruptor Screening program (EDSP) 
component of this registration review case, nor does it provide a 
complete Endangered Species assessment (ESA) for debacarb. However, 
pending the outcome of this action, the EPA is planning to issue an 
interim registration review decision for debacarb.
    Maleic Hydrazide (Proposed Interim Decision). The registration 
review docket for maleic hydrazide (EPA-HQ-OPP-2009-0387) opened in 
September 2009. Maleic hydrazide is a systemic plant growth regulator 
registered for use on tobacco, potato, onions, non-bearing citrus, 
turf, utility and highway rights-of-way, airports, industrial land, 
lawns, recreational areas, ornamental/shade trees and ornamental 
plants. Uses include residential use on turf and lawns as a perimeter 
or spot treatment. EPA published draft human health and ecological risk 
assessments in July 2014. No human health risks of concern were 
identified. The Agency also completed an ecological risk assessment. 
The results of this quantitative risk assessment indicates that the 
currently labeled rates of maleic hydrazide pose a potential for risk 
to non-target terrestrial birds and terrestrial invertebrates. In 
addition, applications may impact sensitive species of semi-aquatic and 
terrestrial monocotyledonous plants (monocots). The Agency completed a 
screening-level ESA and made a ``no effects'' determination for the 
following taxa: Aquatic plants and aquatic freshwater and estuarine/
marine organisms. For all other species applications ``may affect'' or 
are uncertain. Maleic hydrazide has not been evaluated under the EDSP 
nor has it completed ESA section 7 consultation with the U.S. Fish and 
Wildlife Service and the National Marine and Fisheries Service 
(Services). 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 Services for endangered 
species. Pending the outcome of this action, the EPA is planning to 
issue an interim registration review decision for maleic hydrazide.
    Soap Salts (Proposed Interim Decision). The registration review 
docket for soap salts (EPA-HQ-OPP-2008-0519) opened in September 2008. 
Soap Salts are used as acaricides, herbicides, and insecticides on food 
and non-food crops in various settings, chiefly residential and 
agricultural. Ammonium and sodium soap salts are also used as animal 
repellants. EPA published draft human health and ecological risk 
assessments in March 2013. EPA conducted a human health risk assessment 
and did not identify any risks of concern. No human health mitigation 
is being proposed by the Agency for the soap salts at this time. The 
Agency also conducted an ecological risk assessment for the current 
uses of the soap salts. The screening-level risk assessment did find 
the potential for minor risk to terrestrial plants and aquatic 
organisms from the use of potassium and ammonium salts. However, the 
Agency believes there is little actual risk to non-target plants 
exposed to soap salts due to the rapid degradation of soap salts in 
surface water runoff, which was not accounted for in the risk 
assessment model, and the inherent insolubility and low toxicity of the 
soap salts. Therefore, the Agency has no risk concerns from the 
terrestrial or aquatic assessments and is

[[Page 15787]]

not proposing ecological risk mitigation at this time. The Agency also 
completed a screening-level endangered and threatened (listed) species 
assessment for soap salts and identified potential risks to several 
taxa: Freshwater invertebrates, estuarine/marine invertebrates, and 
terrestrial plants. However, at this time in registration review, it is 
premature to make an endangered species effects determination for 
federally listed species and their designated critical habitats under 
ESA. Also, the soap salts have not yet been evaluated under the EDSP. 
Therefore, the Agency's final registration review decision is dependent 
upon the results of the evaluation of risks to threatened and 
endangered species and of potential endocrine disruptor risk. Pending 
the outcome of this action, the EPA is planning to issue an interim 
registration review decision for the soap salts.
    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 docket 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 interim 
registration review decision is supported by the rationales included in 
those documents. Following public comment on a proposed decision, the 
Agency will issue interim registration review decisions for products 
containing the pesticides listed in the table in Unit II.
    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 
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. 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. Links to earlier documents 
related to the registration review of these pesticides are provided at: 
http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm.

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

    Dated: March 17, 2015.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2015-06860 Filed 3-24-15; 8:45 am]
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