Document ID: EPA-HQ-OPP-2005-0287-0029
Agency: epa
Document Type: Notice
Title: Registration Review Final and Interim Decisions
Posted Date: 2014-12-24T05:00Z

[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77477-77480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30214]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 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 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
----------------------------------------------------------------------------------------------------------------
                                                                                       Chemical review manager,
  Registration review case name and              Pesticide docket ID No.               telephone number, email
                 No.                                                                           address
----------------------------------------------------------------------------------------------------------------
4-CPA (Case 2115)...................  EPA-HQ-OPP-2014-0544                           Miguel Zavala, 703-347-
                                                                                      0504,
                                                                                      zavala.miguel@epa.gov.
Acetaminophen (Case 7610)...........  EPA-HQ-OPP-2012-0145                           Bonnie Adler, 703-308-8523,
                                                                                      adler.bonnie@epa.gov.
Allethrins (Case 0473)..............  EPA-HQ-OPP-2010-0022                           Marianne Mannix, 703-347-
                                                                                      0275,
                                                                                      mannix.marianne@epa.gov.
Clofentezine (Case 7602)............  EPA-HQ-OPP-2006-0240                           Wilhelmena Livingston, 703-
                                                                                      308-8025,
                                                                                      livingston.wilhelmena@epa.gov.
Cyromazine (Case 7439)..............  EPA HQ-OPP-2006-0108                           James Parker, 703-306-0469,
                                                                                      parker.james@epa.gov.
Fosthiazate (Case 7604).............  EPA-HQ-OPP-2009-0267                           James Parker, 703-306-0469,
                                                                                      parker.james@epa.gov.
Hexythiazox (Case 7404).............  EPA-HQ-OPP-2006-0114                           Miguel Zavala, 703-347-
                                                                                      0504,
                                                                                      zavala.miguel@epa.gov.
Lactofen (Case 7210)................  EPA-HQ-OPP-2005-0287                           Kelly Ballard, 703-305-
                                                                                      8126,
                                                                                      ballard.kelly@epa.gov.
Macleaya Extract (Case 7024)........  EPA-HQ-OPP-2011-0172                           Susan Bartow, 703-603-0065,
                                                                                      bartow.susan@epa.gov.
Trinexapac-ethyl (Case 7228)........  EPA-HQ-OPP-2008-0657                           Brittany Pruitt, 703-347-
                                                                                      0289,
                                                                                      pruitt.brittany@epa.gov.
Quizalofop (Case 7215)..............  EPA-HQ-OPP-2007-1089                           Khue Nguyen, 703-347-0248,
                                                                                      nguyen.khue@epa.gov.
----------------------------------------------------------------------------------------------------------------

    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]
BILLING CODE 6560-50-P