2015-33300. Registration Review Interim Decisions; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's interim registration review decision for the pesticides listed in Unit II of this notice. 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 to 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 identified in the table in Unit II for the pesticide of interest.

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-2015-0393, 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 decisions for the pesticides in the following table:

Table—Registration Review Interim Decisions

Registration review case name and No.	Docket ID No.	Contact and contact information
2-Propen-1-aminium, N,Ndimethyl-N-2-propenyl-, chloride, Homopolymer (Case 5024)	EPA-HQ-OPP-2015-0255	Donna Kamarei, [phone], [e-mail].
Daminozide (Case 0032)	EPA-HQ-OPP-2009-0242	Margaret Hathaway, [phone], [e-mail].
Dipropyl isocinchomeronate (Case 2215)	EPA-HQ-OPP-2014-0578	Marianne Mannix, [phone], [e-mail].
Fenoxaprop-p-ethyl (Case 7209)	EPA-HQ-OPP-2007-0437	Miguel Zavala, [phone], [e-mail].
Imazapyr (Case 3078)	EPA-HQ-OPP-2014-0200	Matthew Manupella, [phone], [e-mail].
Isoxaben (Case 7219)	EPA-HQ-OPP-2007-1038	Nathan Sell, [phone], [e-mail].
Paclobutrazol (Case 7002)	EPA-HQ-OPP-2006-0109	Khue Nguyen, [phone], [e-mail].
Silica and Silcates (Case 4081)	EPA-HQ-OPP-2007-1140	James Parker, [phone], [e-mail].
Sulfentrazone (Case 7231)	EPA-HQ-OPP-2009-0624	Christina Scheltema, [phone], [e-mail].
Tributyltin Oxide (Case 2620)	EPA-HQ-OPP-2014-0801	Sandra O'Neill, [phone], [e-mail].

The registration review final decisions for several of these cases are dependent on the assessment of listed species and designated critical habitats under the Endangered Species Act (ESA), determinations on the potential for endocrine disruption, and/or evaluation of risks to pollinators.

2-Propen-1-aminium, N, N-dimethyl-N-2-propenyl-, chloride, homopolymer (Interim Decision). The registration review docket for 2-propen-1-aminium, N, N-dimethyl-N-2-propenyl-, chloride, homopolymer opened in August 2015. The Agency did not receive any comments. There is one product containing this active ingredient; which is registered to control mollusks in potable water supplies. The Agency did not call-in any data in support of this registration review case. Additionally, the Agency did not conduct a human health or an environmental risk assessment since label instructions minimize exposure from the product's registered use. Based on the lack of potential exposure, the Agency is making a “no effect” determination for listed species. The final decision on the registration review for this case will occur after an Endocrine Disruption Screen Program (EDSP) Federal Food Drug and Cosmetic Act (FFDCA) section 408(p) determination is made.

Daminozide (Interim Decision). EPA is announcing the availability of the daminozide interim registration review decision. Daminozide is a plant growth regulator (PGR) used to control the development of commercially grown container plants. It is used in nurseries, shade houses, and greenhouses and is applied as a foliage spray that is systemically distributed throughout the plant, a use pattern resulting in little or no potential for off-site drift. Daminozide has no registered food uses and no registered residential uses. EPA conducted both an ecological risk assessment and human health risk assessment for daminozide, and there were no human health risks of concern with registered daminozide uses. The Agency is not calling for mitigation for either ecological or human health risks from daminozide at this time. Except for ongoing ESA consultation, a pollinator risk assessment, and EDSP component of this registration review case, the Agency is proposing that no additional data and no further risk mitigation is needed for daminozide. The Agency's final registration review decision is dependent upon the assessment of risks to threatened and endangered species, pollinators, and an EDSP determination.

Dipropyl isocinchomeronate (Interim Decision). This notice announces the publication of the registration review interim decision for dipropyl isocinchomeronate. Dipropyl isocinchomeronate is registered for use as an insect repellent for use on humans and companion animals to repel flies, gnats, and other flying and biting insects. It is never the sole active ingredient; it is always co-formulated with other insecticides/repellents to broaden their spectrum of repellency. The Agency has concluded that there are no human health risk concerns associated with the use of dipropyl isocinchomeronate. Based on the limited usage, diffusion over a large treatment area, and the low probability of non-target organism exposure, the Agency has not found any ecological risks of concern associated with dipropyl isocinchomeronate and is making a “no effect” determination for all federally listed species and a “no habitat modification” determination for all designated critical habitat for listed species. The Agency concludes that no risk reduction measures or additional data are needed at this time. Dipropyl isocinchomeronate has not been evaluated under the EDSP. The Agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine effects.

Fenoxaprop-p-ethyl (Interim Decision). Fenoxaprop-p-ethyl (FPE) is a selective aryloxy phenoxy-propionate herbicide registered for use on barley, cotton, rice, soybeans, and wheat for post-emergence control of grassy weeds. Additional non-agricultural use sites include conservation reserves, ornamentals, rights-of-way, and turf. In this interim registration review decision for fenoxaprop-p-ethyl, EPA has determined that no additional data are required at this time; however, certain risk reduction measures are necessary at this time. To address potential risk to non-target terrestrial monocots, spray drift management language is required for all fenoxaprop-p-ethyl product registrations used on agricultural, wide area, or rights-of-way use sites. The Agency also is requiring the implementation of label language clarifying use rates, to which the registrants have already agreed. In addition, EPA is requiring label language to include recommended herbicide-resistance management measures. The final registration review decision for fenoxaprop-p-ethyl is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

Imazapyr (Interim Decision). The registration review docket for imazapyr opened in June 2014. Imazapyr is a non-selective systemic herbicide registered for use as pre- and post-emergent treatments to control broad spectrum terrestrial and aquatic weeds including terrestrial annual and perennial grasses, broadleaf weeds, herbs, woody species, and riparian and emergent aquatic weed species. EPA published draft human health and ecological risk assessments at the time of the docket opening for a 60-day public comment period. In this imazapyr interim decision, the Agency has determined that no additional data are required and no changes to the affected registrations or their labeling are needed at this time. In this interim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of imazapyr, nor is it making an endangered species finding. EPA's registration review decision for imazapyr will depend upon the result of an EDSP FFDCA section 408(p) determination, complete pollinator determination, and ESA determination.

Isoxaben (Interim Decision). Isoxaben is a pre-emergent benzamide herbicide registered for use to control broadleaf weeds. It is classified as a Group 21 herbicide that inhibits cell wall biosynthesis. It is registered for non-agricultural uses such as turf grass, ornamentals, and landscape mulch. It is also registered for agricultural use on bearing fruit and nut trees and vineyards. There are no human health risk concerns for isoxaben. However, there are potential ecological risks to aquatic and terrestrial plants and potential chronic risk to mammals. In this interim registration review decision for isoxaben, EPA has determined that no additional data are required at this time and that certain risk reduction measures are necessary, including uniform spray drift management and herbicide resistance management label language. The final registration review decision for isoxaben is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

Paclobutrazol (Interim Decision). Paclobutrazol is a systemic PGR that slows vegetative growth by inhibiting cell elongation. Paclobutrazol is currently registered for use on turf grass (including in parks, athletic fields, golf courses, and rights-of-ways), on ornamentals, as a tree injection, as a soil injection/basal tree drench, and as a seed treatment for various vegetables. There are no registered residential uses of paclobutrazol. EPA conducted a risk assessment for both human health and ecological risk. No human health risks were identified. The ecological risk assessment indicated potential risks to birds, reptiles, and terrestrial-phase amphibians, mammals, terrestrial and aquatic plants, and other aquatic organisms. In the paclobutrazol interim decision, the Agency has determined that certain additional data are required and certain changes to product labeling to address risk from runoff are needed at this time. EPA is making no human health or environmental safety findings associated with the EDSP screening of paclobutrazol, nor is it making an endangered species finding. EPA's registration review decision for paclobutrazol will depend upon the result of an EDSP FFDCA section 408(p) determination, complete pollinator determination, and ESA determination.

The silicates (silica gel and silicon dioxide) (Interim Decision). Silica gel and silicon dioxide are commonly referred to as the silicates, silica silicates or diatomaceous earth (DE) and are found in most soils. Silica gel and silicon dioxide are registered for use as insecticides on a variety of indoor and outdoor areas including crop and residential use sites to treat pests (including ants, boxelder bugs, cockroaches, crickets, slugs, flies, fleas, millipedes, silver-fish, sowbugs and ticks). EPA conducted an ecological risk assessment, including an endangered species assessment. EPA reached a “no effect” determination for all listed species, excluding 57 listed terrestrial invertebrate species, for which a “not likely to adversely affect” determination was made. EPA also concluded that there would be no modification of designated critical habitat. EPA engaged in informal consultation with the U.S. Fish and Wildlife Service (FWS) seeking concurrence on the “not likely to adversely affect” findings. FWS concurred with EPA's “not likely to adversely affect” determination, thus completing consultation. No human health risk assessment was conducted for silica gel and silicon dioxide because no toxicological endpoints were identified to conduct a human health risk assessment. No risk mitigation measures for human health or ecological effects are included in the silica gel and silicon dioxide registration review interim decision. This interim decision does not include the EDSP component of this registration review case. The Agency's final registration review decision will depend upon the result of an EDSP FFDCA section 408(p) determination.

Sulfentrazone (Interim Decision). Sulfentrazone is a broad spectrum, pre-emergence, soil-directed proto porphyrinogen herbicide used to control a variety of weeds. It is registered for use on field crops, specialty vegetable crops, fruit trees, ornamentals, and turf grass. EPA completed quantitative human health and ecological risk assessments for sulfentrazone in 2014, and amended the ecological risk assessment in 2015. The Agency has risk concerns for pesticide handlers that can be adequately mitigated by requiring use of chemical-resistant gloves. In addition, there are potential risk concerns for terrestrial plants. In this interim registration review decision for sulfentrazone, EPA has determined that no additional data are required at this time and that certain risk reduction measures are necessary. These measures include uniform spray drift management language on sulfentrazone labels for products applied by spraying and herbicide resistance management language on all product labels. The Agency's final registration review decision is dependent upon an assessment of listed species and designated critical habitats under the ESA, a determination of the potential for endocrine disruption, and a pollinator risk assessment.

Tributyltin oxide (Interim Decision). There are four EPA registrations for tributyltin oxide for rubber coatings on the sonar domes of nuclear submarines and for oceanographic conductivity sensors. Based on the lack of potential for dietary exposure and no residential uses, the Agency did not conduct a human health risk assessment. Exposure to aquatic organisms would occur only from the small amount of tributyltin oxide potentially leaching from sonar domes, and the Agency believes that risks to non-target, non-listed species are minimal. Tributyltin oxide use as an antifoulant on sonar domes is undergoing ESA consultation with the Department of Defense, EPA, and the Services for compounds covered under EPA's Uniform National Discharge Standards. No EDSP determination has been made at this time. Except for the EDSP component of the tributyltin oxide registration review case, the Agency is not requiring additional data and is not proposing any risk reduction measures for this case. The final decision on the registration review for tributyltin oxide will occur after the ESA consultation and the EDSP FFDCA section 408(p) determination have been made.

Pursuant to 40 CFR 155.57, a registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA. EPA has considered the pesticides listed in light of the FIFRA standard for registration. The interim decision documents in the docket describe the Agency's rationale for issuing registration review interim decisions for these pesticides.

In addition to the interim registration review decision document, the registration review docket for these pesticides 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. EPA has addressed the substantive comments or information received during the 60-day comment period in the interim decision document for each pesticide listed in this document.

Pursuant to 40 CFR 155.58(c), the registration review case docket for each pesticide discussed in this notice will remain open until all actions required in the interim decision have been completed.

Background on the registration review program is provided at: http://www2.epa.gov/​pesticide-reevaluation. Links to earlier documents related to the registration review of this pesticide are provided in the Pesticide Chemical Search data base accessible at: http://iaspub.epa.gov/​apex/​pesticides/​f?​p=​chemicalsearch.

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

Dated: December 23, 2015.

Richard P. Keigwin, Jr.,

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