[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77477-77480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30214]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2014-0817; FRL-9919-30]
Registration Review Final and 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 final/interim
registration review 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 causing
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.
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) 308-8015; email address: [email protected].
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 pesticide specific contact person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0817, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
II. What action is the Agency taking?
Pursuant to 40 CFR 155.58(c), this notice announces the
availability of EPA's final/interim registration review decision for 4-
CPA & salts (Case 2115), Acetaminophen (Case 7610), Allethrins (Case
0473), Clofentezine (Case 7602), Cyromazine (Case 7439), Fosthiazate
(Case 7604), Hexythiazox (Case 7404), Lactofen (Case 7210), Macleaya
Extract (Case 7024), Trinexapac-ethyl (Case 7228), and Quizalofop (Case
7215).
Pursuant to 40 CFR 155.57, a registration review decision is the
Agency's determination whether a pesticide meets, or does not meet, the
standard for registration in FIFRA. EPA has considered for 4-CPA &
salts (Case 2115), Acetaminophen (Case 7610), Allethrins (Case 0473),
Clofentezine (Case 7602), Cyromazine (Case 7439),
[[Page 77478]]
Fosthiazate (Case 7604), Hexythiazox (Case 7404), Lactofen (Case 7210),
Macleaya Extract (Case 7024), Trinexapac-ethyl (Case 7228), and
Quizalofop (Case 7215) in light of the FIFRA standard for registration.
For 4-CPA & salts (Case 2115), Allethrins (Case 0473). Clofentezine
(Case 7602), Cyromazine (Case 7439), Fosthiazate (Case 7604),
Hexythiazox (Case 7404), Lactofen (Case 7210), Macleaya Extract (Case
7024), Trinexapac-ethyl (Case 7228), and Quizalofop (Case 7215), the
Final/Interim Decision documents in the docket describe the Agency's
rationale for issuing a registration review final/interim decision for
each of these pesticides.
In addition to the final/interim registration review decision
document, the registration review docket for 4-CPA & salts,
Acetaminophen, Clofentezine, Cyromazine, Fosthiazate, Hexythiazox,
Lactofen, Macleaya Extract, Trinexapac-ethyl, and Quizalofop also
includes other relevant documents related to the registration review of
this case. The proposed final/interim registration review decisions
were posted to the docket and the public was invited to submit any
comments or new information.
Registration Review Final and Interim Decisions
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Chemical review manager,
Registration review case name and Pesticide docket ID No. telephone number, email
No. address
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4-CPA (Case 2115)................... EPA-HQ-OPP-2014-0544 Miguel Zavala, 703-347-
0504,
[email protected].
Acetaminophen (Case 7610)........... EPA-HQ-OPP-2012-0145 Bonnie Adler, 703-308-8523,
[email protected].
Allethrins (Case 0473).............. EPA-HQ-OPP-2010-0022 Marianne Mannix, 703-347-
0275,
[email protected].
Clofentezine (Case 7602)............ EPA-HQ-OPP-2006-0240 Wilhelmena Livingston, 703-
308-8025,
[email protected].
Cyromazine (Case 7439).............. EPA HQ-OPP-2006-0108 James Parker, 703-306-0469,
[email protected].
Fosthiazate (Case 7604)............. EPA-HQ-OPP-2009-0267 James Parker, 703-306-0469,
[email protected].
Hexythiazox (Case 7404)............. EPA-HQ-OPP-2006-0114 Miguel Zavala, 703-347-
0504,
[email protected].
Lactofen (Case 7210)................ EPA-HQ-OPP-2005-0287 Kelly Ballard, 703-305-
8126,
[email protected].
Macleaya Extract (Case 7024)........ EPA-HQ-OPP-2011-0172 Susan Bartow, 703-603-0065,
[email protected].
Trinexapac-ethyl (Case 7228)........ EPA-HQ-OPP-2008-0657 Brittany Pruitt, 703-347-
0289,
[email protected].
Quizalofop (Case 7215).............. EPA-HQ-OPP-2007-1089 Khue Nguyen, 703-347-0248,
[email protected].
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EPA addresses the comments or information received during the 60-
day comment period in the discussion for each pesticide listed in this
document. During the 60-day comment period, no public comments were
received for fosthiazate or 4-CPA, while cyromazine, hexythiazox and
macleaya extract each received a single comment from the Center for
Biological Diversity which did not affect the Agency's interim
decisions.
4-CPA (Interim Decision). The registration review docket for 4-CPA
(EPA-HQ-OPP-2014-0544) opened in a notice published in the Federal
Register of September 24, 2014 (79 FR 57084) (FRL-9916-39). 4-CPA is a
plant growth regulator registered for use exclusively as a soaking
agent for mung bean sprouts in greenhouse operations to prevent root
formation. EPA conducted a qualitative assessment for both human health
and environmental fate and ecological risks. No risks of concern were
identified and the Agency has made a ``no effect'' determination for
federally listed endangered and threatened (listed) species as well as
a ``no habitat modification'' determination for all designated critical
habitat. In this Interim Registration Review Decision, EPA is not
making human health or environmental safety findings associated with
the Endocrine Disrupter Screening Program (EDSP) for 4-CPA. Before
completing this Registration Review, the Agency will make an EDSP FFDCA
section 408(p) determination.
Acetaminophen (Final Registration Review Decision). Acetaminophen
(also known as the active ingredient in Tylenol) is registered for use
as a vertebrate pesticide to control the invasive brown tree snake in
Guam. The snakes ingest baited mice, which are lethal to the snake.
There are no registered food/feed uses for acetaminophen, and no
tolerances have been established. The Agency conducted an ecological
risk and endangered species assessment for acetaminophen, and
concluded, based on the limited opportunities for non-target species to
be exposed, that there are no risks of concern for native, non-target
organisms associated with the pesticidal use of acetaminophen.
Furthermore, the Agency made a ``no effects'' determination for all
federally listed species and a ``no adverse modification of critical
habitat'' determination. A human health risk assessment was not
conducted due to acetaminophen's well-studied pharmaceutical use and
the extremely limited opportunities for human exposure from its
pesticidal use on Guam. In addition, EPA recently has determined that
acetaminophen is exempt from requirements of the endocrine disruptor
screening program. The Agency proposed in June of 2014 that risk
mitigation measures were not needed, and several comments were received
in support of that decision. This notice finalizes the Agency's
registration review decision on acetaminophen.
Allethrins (Interim Decision). The registration review docket for
the allethrin stereoisomers (EPA-HQ-OPP-20 1 0-0022) opened in a notice
published in the Federal Register of March 30, 2010 (75 FR 16117) (FRL-
8814-4). The allethrin stereoisomers include bioallethrin, esbiol,
esbiothrin, and pynamin forte. All allethrins registrations, with the
exception of three products (71910-2, 71910-3, and 71910-4) were
cancelled effective December 2016. The only remaining registered uses
of allethrins are impregnated mats for control of flying pests such as
mosquitoes.
There are no occupational, food or feed uses of allethrins. EPA
conducted draft assessments for human health risks and ecological risks
for the purposes of registration review. No risks of concern were
identified in the human health risk assessment. The ecological risk
assessment indicated that there was no reasonable expectation for the
remaining registered uses of allethrins stereoisomers to cause direct
or indirect adverse effects to threatened and endangered species. A
``no effect'' determination was made for all federally listed species
as well as a ``no habitat modification'' determination made for all
designated critical habitat. The allethrins stereoisomers have 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 disrupter risk. Pending the outcome of this action,
EPA is issuing an interim
[[Page 77479]]
registration review decision for allethrins.
Clofentezine (Interim Decision). The registration review docket for
clofentezine (EPA-HQ-OPP-2006-0240) opened in a notice published in the
Federal Register of March 2007 (72 FR 14548) (FRL-8118-3). Clofentezine
is an acaricide registered for use to control mites. It is a liquid
formulation for use on almonds, apples, apricots, cherries, Christmas
trees (except California) and Christmas tree plantations, grapes
(except New York), nectarines, ornamentals (greenhouse and outdoor),
peaches, pears, persimmons, and walnuts. There are currently no
registered residential uses of clofentezine. The Agency conducted a
human health risk assessment and did not identify any risks of concern.
The ecological risk assessment determined that all outdoor uses of
clofentezine can potentially lead to direct adverse effects to listed
and non-listed birds. As birds serve as surrogates to reptiles and
terrestrial-phase amphibians, risk to these taxa is also a possibility.
The use of clofentezine is not expected to pose a risk to foraging
(adult) bees; however, there is a potential for risk to non-listed and
listed terrestrial arthropods because of adverse effects to
reproduction and development. To address this uncertainty, the Agency
is requiring a chronic honey bee larval toxicity test to determine any
reproductive effects to pollinators. This interim decision does not
cover the EDSP component of the clofentezine registration review case.
Additionally, the ecological risk assessment for clofentezine did not
come to a conclusion of ``no effect'' to some listed species.
Therefore, consultation with the Fish and Wildlife Service on the
potential risk of clofentezine to some listed species will be
necessary. The Agency's final registration review decision for
clofentezine will occur after an EDSP FFDCA Section 408(p)
determination, and after the result of the Section 7 Endangered Species
consultation with the U.S. Fish and Wildlife Service as well as an
assessment on the non-target exposure to bees.
Cyromazine (Interim Decision). The registration review docket for
cyromazine (EPA-HQ-OPP-2006-0108) opened in a notice published in the
Federal Register of March 28, 2007 (72 FR 14548) (FRL-8118-3).
Cyromazine is a triazine which acts as an insect growth regulator.
Cyromazine is registered for use on several agricultural crops such as
beans, peppers, and tomatoes; it is registered for use on indoor
ornamentals, and to control flies in manure. There are no residential
uses for cyromazine. EPA conducted a human health occupational risk
assessment and did not identify any risks of concern. The ecological
risk assessment identified potential risks to several taxa including
birds, mammals, and bees. To mitigate potential ecological risks, the
Agency will increase the application interval for cyromazine use on
potatoes; add label language for the onion seed treatment use; add
precautionary label language to reduce risk to bees; and, increase the
minimum droplet size for aerial applications. These changes will reduce
estimated risks. The Agency did not reach a conclusion of ``no effect''
to any listed species. Therefore, consultation with the Fish and
Wildlife Service (FWS) on the potential risk of cyromazine to listed
species will be necessary. Cyromazine has not been evaluated under
EDSP. Therefore, the Agency's final registration review decision is
dependent on the results of consultation under section 7 of the
Endangered Species Act (ESA) (16 U.S.C. 1536) with the FWS and the
evaluation of potential endocrine disruptor risk. Pending the outcome
of these actions, EPA is issuing an interim registration review
decision for cyromazine.
Fosthiazate (Interim Decision). The registration review docket for
fosthiazate (EPA-HQ-OPP-2009-0267) opened in a notice published in the
Federal Register of June 24, 2009 (74 FR 30077) (FRL-8422-4).
Fosthiazate is an organophosphate nematicide for use only on tomatoes,
via drip irrigation under plastic. There are no residential uses for
fosthiazate. EPA conducted a human health dietary and occupational risk
assessment for fosthiazate and did not identify any risks of concern.
The ecological risk assessment identified potential risks to several
taxa including birds, mammals, and soil-bound terrestrial
invertebrates. To mitigate potential ecological risks, the agency will
modify the application directions for fosthiazate to increase the
volume of water required for application. The Agency did not not reach
a conclusion of ``no effect'' to listed species. Therefore,
consultation with FWS on the potential risk of fosthiazate to listed
species will be necessary. Fosthiazate has not been evaluated under
EDSP. Therefore, the Agency's final registration review decision is
dependent on the results of consultation under ESA section 7 with FWS
and the evaluation of potential endocrine disruptor risk. The EPA is
issuing an interim registration review decision for fosthiazate.
Hexythiazox (Interim Decision). The registration review docket for
hexythiazox (EPA-HQ-OPP-2006-0114) opened in a notice published in the
Federal Register of February 2, 2007 (72 FR 5050) (FRL-8113-1).
Hexythiazox is an acaricide that acts primarily as a mite growth
inhibitor/ovicide and is used to control mites. It is registered for
use on a variety of agricultural crops, turf, and various residential
plants. The Agency conducted a human health risk assessment and did not
identify any risks of concern. The ecological risk assessment
identified potential risks of concern to non-target terrestrial
invertebrates (e.g., bees) and chronic risk to fish due to lack of
data. The Agency is therefore requiring an honey bee larval toxicity
study to determine any reproductive effects to pollinators. While
chronic risk to fish and non-target invertebrates is uncertain due to
data gaps, the potential risks are expected to be low as hexythiazox is
applied only once per year at a low rate and is not highly persistent
in the environment. The risk assessment for hexythiazox did not come to
a conclusion of ``no effect'' to listed species. Therefore,
consultation with FWS and the National Marine Fisheries Service (NMFS)
(the Services) on the potential risk of hexythiazox to listed species
will be necessary. Hexythiazox has not been evaluated under the EDSP.
Therefore, the Agency's final registration review decision is dependent
on the result of consultation under ESA section 7 with the Services,the
evaluation of potential endocrine disruptor risk, as well as an
assessment on the non-target exposure to bees. Pending the outcome of
these actions, EPA is planning to issue a registration review decision
for hexythiazox.
Lactofen (lnterim Decision). The registration review docket for
lactofen (EPA-HQ-OPP-2005-0287) opened in a notice published in the
Federal Register of February 2, 2007 (72 FR 5050) (FRL-8113-1).
Lactofen is a light dependent peroxidizing herbicide (LDPH) with uses
on conifer seedlings, cotton, kenaf. peanuts, soybean, and with State-
specific uses on fruiting vegetables, okra, and snap beans. There are
no residential uses for lactofen. EPA conducted a human health
occupational risk assessment and did not identify any risks of concern.
The ecological risk assessment identified potential risks to several
different taxa. However, due to the number of conservative assumptions
included in the assessment, and additional use and usage information to
help characterize potential risks, the
[[Page 77480]]
Agency is not proposing mitigation changes at this time. The risk
assessment for lactofen did not come to a conclusion of ``no effect''
to listed species. Therefore, consultation with FWS on the potential
risk of lactofen to listed species will be necessary. Lactofen has not
been evaluated under EDSP. Therefore, the Agency's final registration
review decision is dependent on the results of consultation under ESA
section 7 with FWS and the evaluation of potential endocrine disrupter
risk. Pending the outcome of these actions, EPA is issuing an interim
registration review decision for lactofen.
Macleaya Extract (Interim Decision). The registration review docket
for macleaya extract (EPA-HQ-OPP-2011-0172) opened in March 2011.
Macleaya extract is a plant extract of Macleaya cordata, and is
registered for use only in enclosed commercial greenhouses, as an
ornamental plant fungicide for the control of foliar fungal diseases.
There are no registered food uses of macleaya extract. EPA completed a
qualitative draft human health risk assessment for all macleaya extract
uses. No risks of concern were identified. The Agency did not conduct a
comprehensive ecological risk assessment since the use pattern does not
likely result in outdoor exposures. However, the Agency completed a
qualitative endangered species assessment for the greenhouse use. No
risks of concern were identified and the Agency has made a ``no
effect'' determination for federally listed species and designated
critical habitat. Macleaya extract 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. The EPA is issuing an interim registration review
decision for macleaya extract.
Trinexapac-ethyl (Interim Decision) The registration review docket
for trinexapac-ethyl (EPA-HQ-OPP-2008-0657) opened in a notice
published in the Federal Register of September 15, 2008 (73 FR 53244)
(FRL-8381-3). Trinexapac-ethyl is a plant growth regulator registered
for use by homeowners and professional applicators to manage growth of
barley, grasses grown for seed, oats, sugarcane, triticale, turf grass,
and wheat. Turf grass uses include athletic fields and parks,
commercial and residential lawns, golf courses, and sod farms. It is
also registered for application around flower beds, ornamental trees,
and shrubs. EPA conducted a human health risk assessment and did not
identify any risks of concern. In addition, EPA conducted an ecological
risk assessment. Based on low risk estimates, and the conservative
nature of the risk assessment, the Agency does not anticipate
ecological risks of concern for assessed taxa from currently registered
uses of trinexapac-ethyl. The Agency is not proposing mitigation
changes at this time. However, the Agency is proposing that labels
clarify the single-maximum application rate for liquid turf end-use
products. Two comments were received for the trinexapac-ethyl proposed
interim decision on the detail of the risk assessment. These comments
did not change the interim decision. The risk assessment for
trinexapac-ethyl did not come to a conclusion of ``no effect'' to
listed species. Therefore, consultation with the Services on the
potential risk of trinexapac-ethyl to listed species will be necessary.
Trinexapac-ethyl has not been evaluated under EDSP. Therefore, the
Agency's final registration review decision is dependent on the result
of consultation under ESA section 7 with FWS and the evaluation of
potential endocrine disrupter risk. Pending the outcome of these
actions, EPA is issuing an interim registration review decision for
trinexapac-ethyl.
Quizalofop (Interim Decision). The registration review docket for
quizalofop (EPA-HQ-OPP-2007-1089) opened in 2007. Quizalofop is a
selective post-emergence herbicide and appears as two different
isomers: quizalofop-ethyl and quizalofop-p-ethyl. Quizalofop-ethyl is a
50/50 racemic mixture of R- and S- enantiomers and there are no active
pesticide registrations of this isomer. Quizalofop-p-ethyl is the
purified R-enantiomer and the pesticidally active isomer. For the
Agency's purposes, both isomers will be referred to collectively as
quizalofop. Quizalofop is registered to control annual and perennial
grasses in various crops including Chinese cabbage, cotton, garlic,
grains, legumes, mint, pineapple, soybean, sugar beets, and sunflower.
Quizalofop is also used in non-agricultural settings, such as
cottonwood and poplar plantations, fencerows, roadsides, and other
uncultivated areas. EPA conducted a risk assessment for both human
health and ecological risk. No risks of concern were identified in the
human health risk assessment. The ecological risk assessment indicated
potential risks to amphibians, freshwater fish, non-target monocots,
and terrestrial mammals. The Agency will modify the application
directions for quizalofop to reduce spray drift risk to non-target
organisms. The screening-level endangered species assessment did not
come to a conclusion of ``no effect'' to listed species, therefore,
consultation with FWS on the potential risk of quizalofop to listed
species will be necessary. Quizalofop has not been evaluated under
EDSP. Therefore, the Agency's final registration review decision is
dependent on the result of consultation under ESA section 7 with FWS
and the evaluation of potential endocrine disruptor risk. Pending the
outcome of these actions, EPA is issuing an interim registration review
decision for quizalofop.
Pursuant to 40 CFR 155.58(c), the registration review case docket
for 4-CPA (Case 2115), Allethrins (Case 0473), Clofentezine (Case
7602), Cyromazine (Case 7439), Fosthiazate (Case 7604), Hexythiazox
(Case 7404), Lactofen (Case 7210), Macleaya Extract (Case 7024),
Trinexapac-ethyl (Case 7228), and Quizalofop (Case 7215) will remain
open until all actions required in the final/interim decision have been
completed.
Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of this pesticide are
provided at: http://www2.epa.gov/pesticide-reevaluation/individual-pesticides-registration-review.
Authority: 7 U.S.C. 136 et seq.
Dated: December 16, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-30214 Filed 12-23-14; 8:45 am]
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