2015-07004. Registration Review 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 for several pesticide cases. 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: [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 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-2015-0060, 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 [phone], and the telephone number for the OPP Docket is [phone]. 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 interim registration review decision for fluazinam (case 7013), flumetsulam (case 7229), flutolanil (case 7010), hexaflumuron (case 7413), iron salts (case 4058), piperalin (case 3114), quinclorac (case 7222) and triflumizole (case 7003).

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 such a determination for the cases listed in the table below. The interim registration review decisions for each case are found in the respective pesticide dockets. Information in the dockets describes the Agency's rationale for issuing each interim decision for fluazinam (case 7013), flumetsulam (case 7229), flutolanil (case 7010), hexaflumuron (case 7413), iron salts (case 4058), piperalin (case 3114), quinclorac (case 7222), and triflumizole (case 7003), EPA has considered the following chemicals/cases in light of the FIFRA standard for registration: Fluazinam (case 7013), flumetsulam (case 7229), flutolanil (case 7010), hexaflumuron (case 7413), iron salts (case 4058), piperalin (case 3114), quinclorac (case 7222), and triflumizole (case 7003), the 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 interim registration review decision document, the registration review docket for fluazinam, flumetsulam, flutolanil, hexaflumuron, iron salts, piperalin, quinclorac, and triflumizole also includes other relevant documents related to the registration review of these cases. The proposed interim registration review decisions were posted to the docket and the public was invited to submit any comments or new information.

Table—Registration Review Interim Decisions

Registration review case name and No.	Pesticide Docket ID No.	Chemical Review Manager, telephone number, email address
Fluazinam (case 7013)	EPA-HQ-OPP-2009-0039	Lata Venkateshwara, [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].

Fluazinam. Interim Decision (EPA-HQ-OPP-2009-0039). 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. EPA published an interim proposed registration review decision in the Federal Register on September 24, 2014 (79 FR 57084) (FRL-9916-39). Two comments were received on the proposed interim decision, which did not change the conclusions of the decision. At this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under the Endangered Species Act (ESA). Fluazinam has also not been evaluated under the Endocrine Disruptor Screening Program (EDSP). Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of these actions, EPA is issuing an interim registration review decision for fluazinam at this time.

Flumetsulam. Interim Decision (EPA-HQ-OPP-2008-0625). Flumetsulam has been registered as a pesticide in the United States since 1985, and is currently registered for use as an herbicide for control of broadleaf weeds in field corn and soybeans. Flumetsulam is registered only for agricultural uses; there are no registered residential or public recreational uses of flumetsulam. EPA conducted a human health risk assessment and did not identify any risks of concern. No human health mitigation is being undertaken for flumetsulam at this time by the Agency. The Agency also conducted an ecological risk assessment for existing flumetsulam uses listed above. For existing uses, risks of concern were identified for listed and non-listed aquatic and terrestrial plant species from the use of flumetsulam on corn and soybeans. Listed aquatic and terrestrial animals may also be affected through indirect effects because of the potential effects on listed and non-listed aquatic and terrestrial plant species. EPA published a proposed interim registration review decision for flumetsulam in the Federal Register on September 24, 2014 (79 FR 57084) (FRL-9916-39). The document includes various label changes to mitigate risks to non-target plants by reducing spray drift. Comments from three stakeholders were received on the proposed interim decision; these comments did not change the conclusions of the decision or the proposed mitigation to address ecological risks. At this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under the ESA. Also, flumetsulam has not yet been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of these actions, EPA is issuing an interim registration review decision for flumetsulam at this time.

Flutolanil. Interim Decision (EPA-HQ-OPP-2008-0148). 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. EPA published an interim proposed registration review decision in the Federal Register on September 24, 2014. One comment was received on the proposed interim decision, which did not change the conclusions of the decision or the proposed mitigation to address risks to aquatic organisms. At this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under the ESA. Flutolanil has also not been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of these actions, EPA is issuing an interim registration review decision for flutolanil at this time.

Hexaflumuron. Interim Decision (EPA-HQ-OPP-2009-0568). 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 the ESA. EPA published an interim proposed registration review decision for hexaflumuron in the Federal Register on September 24, 2014. 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 issuing an interim registration review decision for hexaflumuron at this time.

Iron Salts. Interim Decision (EPA-HQ-OPP-2008-0626). The iron salts registration review case includes two active chemicals, ferric sulfate and ferrous sulfate monohydrate. Iron is the fourth most abundant element and the second most abundant metal in the earth's crustal rocks. Iron occurs in a wide variety of minerals, and it is present in foods naturally and through added ingredients. Iron salts are herbicides registered for use on outdoor lawns and ornamentals to control mosses in a variety of residential and commercial areas. There are no registered agricultural uses of iron salts products. EPA conducted a human health risk assessment and did not identify any risks of concern. The Agency relied upon the previous iron salts human health risk assessment, completed for the iron salts Reregistration Eligibility Decision (RED), to support the registration review of iron salts since no significant changes have been made since the RED that impact the risk conclusions for this case. The Agency also conducted an ecological risk assessment for existing uses of iron salts listed above. For existing uses, EPA does not expect iron salts to have direct or indirect adverse effects to non-listed and listed terrestrial vertebrates, terrestrial plants, terrestrial invertebrates, and aquatic organisms or to adversely modify any designated critical habitat for such species and has made a “no effect” determination under the ESA for those species and designated critical habitat for such species. EPA published an interim proposed registration review decision for iron salts in the Federal Register on September 24, 2014. One comment was received on the proposed interim decision; the comment did not change the conclusions of the decision. At this time in registration review, iron salts has not yet been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of potential endocrine disruptor risk. Pending the completion of EDSP work for this case, EPA is issuing an interim registration review decision for iron salts at this time.

Piperalin. Interim Decision (EPA-HQ-OPP-2009-0483). Currently, piperalin is registered exclusively for use to control powdery mildew on ornamental plants, shrubs, vines, and trees grown in commercial greenhouses and other similar enclosed structures with nonporous coverings. EPA conducted a human health risk assessment and did not identify any risks of concern. The Agency did not conduct a comprehensive ecological risk assessment since the use pattern does not likely result in outdoor exposures. 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. 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. The EPA is issuing an interim registration review decision for piperalin.

Quinclorac. Interim Decision (EPA-HQ-OPP-2007-1135). 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 human health risk assessment and did not identify any risks of concern. No human health mitigation is being undertaken for quinclorac at this time by the Agency. However, a data gap is identified by the Quinclorac human health risk assessment: An updated analytical standard for the quinclorac DMA salt to the EPA National Pesticide Standards Repository. The Agency also conducted an ecological risk assessment for existing listed above. For existing uses, risks of concern were identified for listed and non-listed terrestrial plant species as well as listed aquatic vascular plants from use of quinclorac on rice. EPA published an interim proposed registration review decision for quinclorac in the Federal Register on September 24, 2014. The document includes various label changes to mitigate risks to terrestrial plants by reducing spray drift and also calls for updates to quinclorac tolerances. One comment was received on the proposed interim decision, which did not change the conclusions of the decision or the proposed mitigation to address ecological risks. At this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under the ESA. Quinclorac has also not yet been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of these actions, EPA is issuing an interim registration review decision for quinclorac this time.

Triflumizole. Interim Decision (EPA-HQ-OPP-2006-0115). 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 preplant seed piece treatment on pineapples. EPA conducted a quantitative human health risk assessment and identified occupational handler and post-application exposure risks of concern for several use scenarios. To mitigate the occupational handler risks of concern when applying triflumizole with open cab air blast equipment to apple, pear, and cherry, the technical registrant Chemtura agreed to require additional personal protective equipment of a chemical resistant hat. To address occupational post-application risks of concern, the registrant agreed 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. 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. EPA published a proposed interim registration review decision for triflumizole in the Federal Register on September 24, 2014. The document includes the various label changes to mitigate risks detailed previously. Only one comment from the Center for Biological Diversity was received on the proposed interim decision; this comment did not change the conclusions of the decision or the proposed mitigation to address the risks. At this time in registration review, it is premature to make an endangered species effects determination for federally listed species and their designated critical habitats under the ESA. Also, triflumizole has not yet been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the results of the evaluation of risks to threatened and endangered species and of potential endocrine disruptor risk. Pending the outcome of these actions, EPA is issuing an interim registration review decision for triflumizole at this time.

Pursuant to 40 CFR 155.58(c), the registration review case docket for fluazinam (case 7013), flumetsulam (case 7229), flutolanil (case 7010), hexaflumuron (case 7413), iron salts (case 4058), piperalin (case 3114), quinclorac (case 7222), and triflumizole (case 7003) 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 these pesticides are provided at: http://www2.epa.gov/​pesticide-reevaluation/​individualpesticides-registration-review.

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

Dated: March 17, 2015.

Richard P. Keigwin, Jr.,

Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.