Document ID: EPA-HQ-OPP-2007-1135-0019
Agency: epa
Document Type: Notice
Title: Pesticide Registrations: Registration Review Proposed Interim Decision
Posted Date: 2014-09-24T04:00Z

[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57084-57087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22739]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0628; FRL-9916-39]

Registration Review Proposed Interim Decision; 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 for public comment. Registration 
review is EPA's periodic review of pesticide registrations to ensure 
that each pesticide continues to satisfy the statutory standard for 
registration, that is, that the pesticide can perform its intended 
function without unreasonable adverse effects on human health or the 
environment. Through this program, EPA is ensuring that each 
pesticide's registration is based on current scientific and other 
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before November 24, 2014.

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

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

[[Page 57085]]

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.

          Table--Registration Review Proposed Interim Decisions
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.                   ID No.         No., email address
------------------------------------------------------------------------
4-CPA (Case 2115).............  EPA-HQ-OPP-2014-0  Miguel Zavala, (703)
                                 544.               347-0504,
                                                    zavala.miguel@epa.gov.
Allethrins (Case 0437)........  EPA-HQ-OPP-2010-0  Marianne Mannix,
                                 022.               (703) 347-0275,
                                                    mannix.marianne@epa.gov.
Fluazinam (Case 7013).........  EPA-HQ-OPP-2009-0  Avivah Jakob, (703)
                                 039.               305-3328,
                                                    jakob.avivah@epa.gov
                                                    .
Flumetsulam (Case 7229).......  EPA-HQ-OPP-2008-0  Katherine St. Clair,
                                 625.               (703) 347-8778,
                                                    stclair.katherine@epa.gov.
Flutolanil (Case 7010)........  EPA-HQ-OPP-2008-0  Garland Waleko, (703)
                                 148.               308-8049,
                                                    waleko.garland@epa.gov.
Hexaflumuron (Case 7413)......  EPA-HQ-OPP-2009-0  Ricardo Jones, (703)
                                 568.               347-0493,
                                                    jones.ricardo@epa.gov.
Iron Salts (Case 4058)........  EPA-HQ-OPP-2008-0  Katherine St. Clair,
                                 626.               (703) 347-8778,
                                                    stclair.katherine@epa.gov.
Piperalin (Case 3114).........  EPA-HQ-OPP-2009-0  Matthew Manupella,
                                 483.               (703) 347-0411,
                                                    manupella.matthew@epa.gov.
Quinclorac (Case 7222)........  EPA-HQ-OPP-2007-1  Margaret Hathaway,
                                 135.               (703) 305-5076,
                                                    hathaway.margaret@epa.gov.
Triflumizole (Case 7003)......  EPA-HQ-OPP-2006-0  Steven Snyderman,
                                 115.               (703) 347-0249
                                                    snyderman.steven@epa.gov.
------------------------------------------------------------------------

    4-CPA (Proposed Interim Decision). The registration review docket 
for 4-CPA (EPA-HQ-OPP-2014-0544) is opening for public comment on a 
combined Work Plan, Summary Document, and Proposed Interim Registration 
Review Decision. 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 Proposed 
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 Federal Food, Drug, and Cosmetic 
Act (FFDCA) section 408(p) determination.
    Allethrins (Proposed Interim Decision). The registration review 
docket for the allethrin stereoisomers (EPA-HQ-OPP-2010-0022) opened in 
a notice published in the Federal Register of March 31, 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 disruptor risk. Pending 
the outcome of this action, EPA is planning to issue an interim 
registration review decision for allethrins.
    Fluazinam (Proposed Interim Decision). The registration review 
docket for fluazinam (EPA-HQ-OPP-2009-0039) opened in a notice 
published in the Federal Register of September 23, 2009 (74 FR 48559) 
(FRL-8434-6). Fluazinam is a contact fungicide of the pyridinamine 
class registered for agricultural use on a variety of crops, including 
peanuts, potatoes, and beans. EPA conducted a human health risk 
assessment and did not identify any risks of concern. In addition, EPA 
conducted an environmental fate and effects risk assessment. Based on 
low-risk estimates, and the conservative nature of the risk assessment, 
the Agency has determined that fluazinam use does not pose unreasonable 
risks to the environment from currently registered uses of fluazinam. 
The Agency is not proposing mitigation changes at this time. The risk 
assessment for fluazinam did not come to a conclusion of ``no effect'' 
to listed species. Therefore, consultation with the U.S. Fish and 
Wildlife Service and the National Marine Fisheries Service (Services) 
on the potential risk of fluazinam to listed species will be necessary. 
Fluazinam has not been evaluated under the EDSP. Therefore, the 
Agency's final registration review decision is dependent on the result 
of consultation under Endangered Species Act (ESA)

[[Page 57086]]

Section 7 with the Services, 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 fluazinam.
    Flumetsulam (Proposed Interim Decision). The registration review 
docket for flumetsulam (EPA-HQ-OPP-2008-0625) opened in September 2008. 
Flumetsulam is a sulfonanilide herbicide in the triazolopyrimidine 
chemical class registered to control broadleaf weeds in field corn, 
soybeans, kidney beans, navy beans and pinto beans. There are no 
residential or public recreational uses of flumetsulam. EPA completed a 
draft human health risk assessment for all flumetsulam uses and did not 
identify any risks of concern. The ecological risk assessment indicated 
potential risks to non-target terrestrial and aquatic plants. The 
Agency is proposing mitigation to reduce spray drift to non-target 
plants. The ecological risk assessment did not come to a conclusion of 
``no effect'' to all listed species. Therefore, a consultation with the 
Services on the potential risk of flumetsulam to listed species will be 
necessary. Flumetsulam has not been evaluated under the EDSP. 
Therefore, the Agency's final registration review decision is dependent 
upon the result of Section 7 Endangered Species consultation with the 
Services, 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 flumetsulam.
    Flutolanil (Proposed Interim Decision). The registration review 
docket for flutolanil (EPA-HQ-OPP-2008-0148) opened in a notice 
published in the Federal Register of September 15, 2008 (73 FR 53244) 
(FRL-8381-3). Flutolanil is a systemic benzanilide fungicide first 
registered by EPA in 1993, used to control fungal diseases in both food 
crops (peanuts, potatoes, rice,) and non-food sites (turf, greenhouse, 
field-grown and potted ornamentals). Flutolanil has both protective and 
curative activity. EPA completed a qualitative draft human health risk 
assessment for all flutolanil uses and for proposed label amendments 
for Brassica (cole) leafy vegetables (crop group 5), turnip greens, 
rice, turf, and peanuts. No risks of concern were identified. The 
Agency also conducted an ecological risk assessment for existing and 
proposed uses listed above. For existing uses, risks of concern were 
identified for freshwater fish and estuarine/marine invertebrates in 
the water column and sediment, and for terrestrial dicots and aquatic 
non-vascular plants for some uses. The risk assessment for flutolanil 
did not come to a conclusion of ``no effect'' to listed species. 
Flutolanil has also not been evaluated under the EDSP. Therefore, the 
Agency's final registration review decision is dependent upon the 
result of Section 7 Endangered Species consultation with the Services 
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 flutolanil.
    Hexaflumuron (Proposed Interim Decision). The registration review 
docket for hexaflumuron (EPA-HQ-OPP-2009-0568) opened on September 23, 
2009 (74 FR 48559) (FRL-8343-6). Hexaflumuron is an insecticide/
termiticide applied in above- and below-ground termite bait systems, 
and is intended to be used near commercial, recreational or residential 
structures. EPA completed a qualitative human health risk assessment 
and no risks of concern were identified. The Agency also conducted an 
ecological risk assessment and determined that hexaflumuron does not 
pose unreasonable risk to the environment. The Agency has made an 
endangered species effects determination of ``no effects'' for aquatic 
organisms and a determination of ``no habitat modification'' to all 
designated critical habitats under ESA. Hexaflumuron has not been 
evaluated under EDSP. Therefore, the Agency's final registration review 
decision is dependent on the result of the Section 7 Endangered Species 
consultation with the Fish and Wildlife Service, and the potential 
endocrine disruptor risk. Pending the outcome of these actions, EPA is 
planning to issue an interim registration review decision for 
hexaflumuron.
    Iron Salts (Proposed Interim Decision) The registration review 
docket for iron salts (EPA-HQ-OPP-2008-0626) opened in December 2008. 
There are two active chemicals in this case, ferric sulfate and ferrous 
sulfate monohydrate, which are collectively referred to as the iron 
salts. Iron salts are registered as herbicides to control moss on a 
variety of non-agricultural sites. Due to the ubiquitous nature of the 
iron salts, the lack of human health hazard and risk concern, EPA's 
review of this case did not require a new human health risk assessment 
to support the existing uses. The ecological risk assessment came to a 
conclusion of ``no effect'' to all listed species. Therefore, a 
consultation with the Services on the potential risk of iron salts to 
listed species will not be necessary. Iron salts has not been evaluated 
under the EDSP. Therefore, the Agency's final registration review 
decision is dependent upon the result of the evaluation of potential 
endocrine disruptor risk. Pending the outcome of this action, EPA is 
planning to issue an interim registration review decision for iron 
salts.
    Piperalin (Proposed Interim Decision). The registration review 
docket for piperalin (EPA-HQ-OPP-2009-0483) opened in September 2009. 
Piperalin is registered to treat powdery mildew fungal infections of 
ornamental plants, shrubs, vines, and trees grown in commercial 
greenhouses. There are no registered outdoor or residential uses. EPA 
completed a qualitative draft human health risk assessment for all 
piperalin 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 as well 
as a ``no habitat modification'' determination for all designated 
critical habitat. Piperalin has not been evaluated under the EDSP. 
Therefore, the Agency's final registration review decision is dependent 
upon the result of the evaluation of potential endocrine disruptor 
risk. Pending the outcome of this action, EPA is planning to issue an 
interim registration review decision for piperalin.
    Quinclorac (Proposed Interim Decision). The registration review 
docket for quinclorac (EPA-HQ-OPP-2007-1135) opened in December 2007. 
Quinclorac is a systemic herbicide used to control broadleaf and grass 
weeds via ground spray or aerial application. Currently registered uses 
of quinclorac include turf grasses, sorghum, wheat, rangeland/pasture, 
rights-of way/fencerow/hedgerow, grass grown for seed, fallow land, 
grass forage/fodder/hay, rice, rhubarb, and low growing berry (except 
strawberry) subgroup 13-07H. EPA conducted a quantitative assessment 
for both human health and ecological risks. No risks of concern were 
identified in the human health risk assessment. The ecological risk 
assessment identified possible risks to both listed and non-listed non-
target terrestrial plants. Therefore a ``no effect'' determination 
could not be made for all federally listed species and designated 
critical habitat. The proposed interim decision document outlines 
labeling

[[Page 57087]]

changes to reduce the risk from spray drift to non-target terrestrial 
plants. Quinclorac has not been evaluated under the EDSP. Therefore, 
the Agency's final registration review decision is dependent upon the 
result of Section 7 Endangered Species consultation with the Services, 
and the result of the evaluation of potential endocrine disruptor risk. 
Pending the outcome of these actions, EPA is planning to issue an 
interim registration review decision for quinclorac.
    Triflumizole (Proposed Interim Decision). The registration review 
docket for triflumizole (EPA-HQ-OPP-2006-0115) opened in March 2007. 
Triflumizole is a broad spectrum, imidazole fungicide (group 3) that 
inhibits ergosterol biosynthesis in fungi, acting as a systemic 
fungicide. Triflumizole is registered for application to a number of 
food and non-food crops, including ornamentals in greenhouses/shade 
houses, interior scapes, and Christmas trees/conifers on nurseries and 
plantations. It is also used as a pre-plant seed piece treatment on 
pineapples. EPA conducted a qualitative human health risk assessment 
and identified occupational handler and post-application exposure risks 
of concern for several use scenarios. EPA is proposing additional 
personal protective equipment of a chemical-resistant hat to address 
occupational handler risks of concern when applying triflumizole with 
open cab air blast equipment to apple, pear, and cherry. To address 
post-application risks of concern, EPA is proposing to increase re-
entry intervals (REIs) for grapes (table and raisin) to 1-day and hops 
to 3 days. The ecological risk assessment identified potential risks to 
listed mammals, birds, herpatofauna, freshwater fish, and aquatic 
estuarine-marine invertebrates; however, the only non-listed taxa of 
concern was chronic risk to mammals. To mitigate potential chronic risk 
to non-listed mammals, the registrant agreed to label changes reducing 
the number of applications per year for certain crops and increasing 
the retreatment interval (RTI) to reflect typical usage. The risk 
assessment for triflumizole did not come to a conclusion of ``no 
effect'' to listed species. Therefore, consultation with the Services 
on the potential risk of triflumizole to listed species will be 
necessary. Triflumizole has not been evaluated under the EDSP. 
Therefore, the Agency's final registration review decision is dependent 
upon the result of Section 7 Endangered Species consultation with the 
Services 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 triflumizole.
    The registration review docket for a pesticide includes earlier 
documents related to the registration review of the case. For example, 
the review typically opens with a summary document, containing a 
Preliminary Work Plan, for public comment. A final Work Plan is placed 
in the docket following public comment on the initial docket. The 
documents in the dockets describe EPA's rationales for conducting 
additional risk assessments, as well as the Agency's subsequent risk 
findings and consideration of possible risk mitigation measures. A 
proposed registration review decision will be supported by the 
rationales included in those documents. Following public comment on a 
proposed decision, the Agency will issue an interim registration review 
decision.
    The registration review program is being conducted under 
congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public. Section 3(g) of 
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 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 as appropriate. The final registration review decision will 
explain the effect that any comments had on the decision.
    Background on the registration review program is provided at: 
http://www2.epa.gov/pesticide-reevaluation. Information regarding 
earlier documents related to the registration review of these 
pesticides can be found at: http://www2.epa.gov/pesticide-reevaluation/individual-pesticides-registration-review.

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.

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

    Dated: September 17, 2014.
Patricia L. Parrott,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2014-22739 Filed 9-23-14; 8:45 am]
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