2014-22739. Registration Review Proposed Interim Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; email address: [e-mail].

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.

Table—Registration Review Proposed Interim Decisions

Registration review case name and No.	Pesticide docket ID No.	Chemical review manager, telephone No., email address
4-CPA (Case 2115)	EPA-HQ-OPP-2014-0544	Miguel Zavala, [phone], [e-mail].
Allethrins (Case 0437)	EPA-HQ-OPP-2010-0022	Marianne Mannix, [phone], [e-mail].
Fluazinam (Case 7013)	EPA-HQ-OPP-2009-0039	Avivah Jakob, [phone], [e-mail].
Flumetsulam (Case 7229)	EPA-HQ-OPP-2008-0625	Katherine St. Clair, [phone], [e-mail].
Flutolanil (Case 7010)	EPA-HQ-OPP-2008-0148	Garland Waleko, [phone], [e-mail].
Hexaflumuron (Case 7413)	EPA-HQ-OPP-2009-0568	Ricardo Jones, [phone], [e-mail].
Iron Salts (Case 4058)	EPA-HQ-OPP-2008-0626	Katherine St. Clair, [phone], [e-mail].
Piperalin (Case 3114)	EPA-HQ-OPP-2009-0483	Matthew Manupella, [phone], [e-mail].
Quinclorac (Case 7222)	EPA-HQ-OPP-2007-1135	Margaret Hathaway, [phone], [e-mail].
Triflumizole (Case 7003)	EPA-HQ-OPP-2006-0115	Steven Snyderman, [phone] [e-mail].

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) 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 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.