Document ID: EPA-HQ-OPP-2006-0108-0040
Agency: epa
Document Type: Notice
Title: Registration Review Proposed Interim Decisions
Posted Date: 2014-07-23T04:00Z

[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42786-42790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17244]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0473; FRL-9913-38]

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 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.

DATES: Comments must be received on or before September 22, 2014.

ADDRESSES: Submit your comments, identified by the 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.

[[Page 42787]]

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 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 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 interim registration review decisions for the 
pesticides shown in the table in this unit, and opens a 60-day public 
comment period on the proposed interim decisions.
    1. Acetaminophen (proposed interim decision). The registration 
review docket for acetaminophen (EPA-HQ-OPP-2012-0145) opened in a 
notice published in the Federal Register of March 28, 2012 (77 FR 
18810) (FRL-9342-1). Acetaminophen 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. No pesticide tolerances 
have been established. EPA did not conduct a human health risk 
assessment because acetaminophen's pharmaceutical use is well-studied 
and opportunities for exposure from its pesticidal use are extremely 
limited. The Agency conducted a quantitative ecological risk assessment 
for acetaminophen. Baited mice are not likely to be consumed or 
consumed in quantity by resident animals other than the brown tree 
snake, the acetaminophen in the mice is not likely to end up in aquatic 
environments, and there is little potential for exposure to plants. The 
Agency has concluded that there are no risks of concern for native, 
non-target organisms associated with the pesticidal use of 
acetaminophen. The Agency has made a ``no effect'' determination for 
all federally listed species and a ``no adverse modification of 
critical habitat'' determination. Acetaminophen has not been evaluated 
under the Endocrine Disruptor Screening Program (EDSP). Therefore, the 
Agency's final registration review decision is dependent on the results 
of the evaluation of potential endocrine disruptor risks. Pending the 
outcome of this action, EPA is planning to issue an interim 
registration review decision for acetaminophen.
    2. Clofentezine (proposed interim decision). The registration 
review docket for clofentezine (EPA-HQ-OPP-2006-0240) opened in a 
notice published in the Federal Register of March 28, 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, grapes (except New York), 
nectarines, ornamentals (greenhouse and outdoor), peaches, pears, 
persimmons, and walnuts. There are currently no registered residential 
uses of clofentezine. Based on the human health risk assessment 
conducted in support of registration review for clofentezine, the 
Agency determined that there are no human health risks of concern for 
the currently registered uses of clofentezine. Based on the ecological 
risk assessment that was completed in support of registration review 
for clofentezine, EPA has determined that all outdoor uses of 
clofentezine can potentially lead to direct adverse effects to listed 
and non-listed birds.
    The chronic risk level of concern (LOC) was exceeded by dietary 
risk quotients (RQs) for birds. As birds serve as surrogates to 
reptiles and terrestrial-phase amphibians, risk to these taxa is also a 
possibility. The chronic risk to mammals is uncertain and is expected 
to be limited. The dose-based risk assessment concludes that the 
chronic RQs slightly exceeds the chronic LOC for small to medium 
mammals feeding exclusively on short grass, but this was based on a 
study which showed no effects to growth, reproduction, or survival at 
the highest dose tested. Clofentezine is moderately persistent in the 
terrestrial environment and is expected to decline to below toxic 
levels approximately 1 to 2 weeks after application.
    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. Use of clofentezine is not expected to 
cause direct or indirect adverse effects to non-listed or listed fish, 
aquatic invertebrates, or aquatic plants. Thus, a ``no effect'' 
determination is made for all listed aquatic organisms. Several lines

[[Page 42788]]

of evidence indicate that clofentezine has low toxicity to plants. 
Therefore, EPA concludes that use of clofentezine will not pose risk to 
terrestrial, semi-aquatic (monocots, and dicots) or aquatic plants, and 
is not expected to harm listed species of plants. Thus, a ``no effect'' 
determination is made for all listed plants.
    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 U.S. 
Fish and Wildlife Service (FWS) on the potential risk of clofentezine 
to some listed species will be necessary. The Agency is issuing a 
proposed interim registration review decision pending the evaluation of 
potential endocrine disruptor risk and consultation with FWS.
    3. Cyromazine (proposed 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 is proposing to 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; use; and, increase the minimum droplet size for aerial 
applications. The proposed changes will reduce estimated risks, but 
will not reach a conclusion of ``no effect'' to listed species. 
Therefore, consultation with 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 planning to issue an interim registration 
review decision for cyromazine.
    4. Fosthiazate (proposed 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 is proposing to modify the application directions for 
fosthiazate. The proposed change will reduce estimated risks, but will 
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. Pending the 
outcome of these actions, EPA is planning to issue an interim 
registration review decision for fosthiazate.
    5. Hexythiazox (proposed 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 areas of potential risk of uncertainty to 
terrestrial invertebrates, bees, and chronic risk to fish due to lack 
of data. The Agency is therefore requiring a bee study to determine any 
productive effects to pollinators. While chronic risk to fish and non-
target invertebrates is uncertain due to data gaps, the potential risks 
expected to be low due to as hexythiazox is applied only once per year 
at a low rate and is not highly persistent in the environment. The 
Agency has completed a partial ESA analysis and is making a no effect 
determination under the ESA for direct adverse effects to listed 
mammalian, avian (and reptile surrogates) and aquatic plant (vascular 
and nonvascular). The analysis for indirect effects to listed species 
in these taxa or effects to their designated critical habitat has not 
yet been completed. 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 FWS and the evaluation of potential endocrine 
disruptor risk. Pending the outcome of these actions, EPA is planning 
to issue an interim registration review decision for hexythiazox.
    6. Lactofen (proposed interim 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, and soybean, 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 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 disruptor risk. Pending the outcome 
of these actions, EPA is planning to issue an interim registration 
review decision for lactofen.
    7. Macleaya extract (proposed interim decision). The registration 
review docket for macleaya extract (EPA-HQ-OPP-2011-0172) opened in a 
notice published in the Federal Register of March 30, 2011 (76 FR 
17646) (FRL-8868-9). Macleaya extract is a plant extract of Macleaya 
cordata, and is registered for use only in enclosed commercial 
greenhouses, as an

[[Page 42789]]

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 also conducted an 
ecological risk assessment and endangered species effects 
determination. No risks of concern were identified and the Agency has 
made a ``no effect'' determination for federally listed species and a 
``No Habitat Modification'' determination for all designated critical 
habitats under ESA. Macleaya extract has not been evaluated under EDSP. 
Therefore, the Agency's final registration review decision is dependent 
on the result of the evaluation of potential endocrine disruptor risk. 
Pending the outcome of this action, EPA is planning to issue an interim 
registration review decision for macleaya extract.
    8. Quizalofop (proposed interim decision). The registration review 
docket for quizalofop (EPA-HQ-OPP-2007-1089) opened in a notice 
published in the Federal Register of December 19, 2007 (72 FR 71893) 
(FRL-8342-9). 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 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 is proposing mitigation to reduce spray drift risk to non-target 
organisms. The ecological risk 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 planning to issue an interim registration review 
decision for quizalofop.
    9. Trinexapac-ethyl (proposed 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. 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 planning to issue an interim registration review 
decision for trinexapac-ethyl.

          Table--Registration Review Proposed Interim Decisions
------------------------------------------------------------------------
                                                        Chemical review
  Registration review case name    Pesticide docket   manager, telephone
           and number               identification       number, email
                                        number              address
------------------------------------------------------------------------
Acetaminophen (Case 7610).......  EPA-HQ-OPP-2012-01  Bonnie Adler,
                                   45.                 (703) 308-8523,
                                                       adler.bonnie@epa.gov.
Clofentezine (Case 7602)........  EPA-HQ-OPP-2006-02  Wilhelmena
                                   40.                 Livingston, (703)
                                                       308-8025,
                                                       livingston.wilhelmena@epa.gov.
Cyromazine (Case 7439)..........  EPA-HQ-OPP-2006-01  James Parker,
                                   08.                 (703) 306-0469,
                                                       parker.james@epa.gov.
Fosthiazate (Case 7604).........  EPA-HQ-OPP-2009-02  James Parker,
                                   67.                 (703) 306-0469,
                                                       parker.james@epa.gov.
Hexythiazox (Case 7404).........  EPA-HQ-OPP-2006-01  Molly Clayton,
                                   14.                 (703) 603-0522,
                                                       clayton.molly@epa.gov.
Lactofen (Case 7210)............  EPA-HQ-OPP-2005-02  Kelly Ballard,
                                   87.                 (703) 305-8126,
                                                       ballard.kelly@epa.gov.
Macleaya Extract (Case 7024)....  EPA-HQ-OPP-2011-01  Susan Bartow,
                                   72.                 (703) 603-0065,
                                                       bartow.susan@epa.gov.
Quizalofop (Case 7215)..........  EPA-HQ-OPP-2007-10  Khue Nguyen, (703)
                                   89.                 347-0248,
                                                       nguyen.khue@epa.gov.
Trinexapac-ethyl (Case 7228)....  EPA-HQ-OPP-2008-06  Kaitlin Keller,
                                   57.                 (703) 308-8172,
                                                       keller.kaitlin@epa.gov.
------------------------------------------------------------------------

    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

[[Page 42790]]

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 for the registration review of 
the pesticides included in the table in Unit II.A., as well as the 
Agency's subsequent risk findings and consideration of possible risk 
mitigation measures. These proposed interim registration review 
decisions are supported by the rationales included in those documents.
    Following public comment, the Agency is planning to issue interim 
registration review decisions for products containing the pesticides 
listed in the table in Unit II.A.
    The registration review program is being conducted under 
congressionally mandated timeframes, 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 the Federal Register 
of August 9, 2006 (71 FR 45720) (FRL-8080-4) and became effective 
October 10, 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 (7 U.S.C. 136a(g)).
    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 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. The final 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. 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.

B. What is the Agency's authority for taking this action?

    Section 3(g) of FIFRA (7 U.S.C. 136a(g)) and 40 CFR part 155, 
subpart C, provide authority for this action.

List of Subjects

    Environmental protection, Acetaminophen, Administrative practice 
and procedure, Clofentezine, Cyromazine, Fosthiazate, Hexythiazox, 
Lactofen, Macleaya extract, Pesticides and pests, Quizalofop, and 
Trinexapac-ethyl.

    Dated: July 15, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-17244 Filed 7-22-14; 8:45 am]
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