2015-26299. 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 decisions 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 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. This document also announces the Agency's closure of the registration review docket for flufenpyr-ethyl. All pesticide products containing flufenpyr-ethyl have been cancelled.

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 decision or case closure document for the pesticides in the following table:

Registration review case name and No.	Docket ID No.	Contact and contact information
Carbon and Carbon Dioxide (Case 4019)	EPA-HQ-OPP-2007-0705	James Parker, [phone], [e-mail].
Debacarb (2-EEEBC) (Case 4031)	EPA-HQ-OPP-2008-0802	Roy Johnson, [phone], [e-mail].
Flufenpyr-ethyl (Case 7262)	EPA-HQ-OPP-2014-0768	Tracy Perry, [phone], [e-mail].
Inorganic Nitrate-Nitrite (Case 4052)	EPA-HQ-OPP-2007-1118	Brittany Pruitt, [phone], [e-mail].
Maleic Hydrazide (Case 0381)	EPA-HQ-OPP-2009-0387	Ricardo Jones, [phone], [e-mail].
Soap Salts (Case 4083)	EPA-HQ-OPP-2008-0519	Tracy Perry, [phone], [e-mail].
Sulfur (Case 0031)	EPA-HQ-OPP-2008-0176	Jose Gayoso, [phone], [e-mail].

The registration review final decisions for these cases are dependent on the assessments of threatened and endangered (listed) species under the Endangered Species Act (ESA), determinations on the potential for endocrine disruption, and/or pollinator risk assessments.

Debacarb (Interim Decision). The registration review docket for debacarb (EPA-HQ-OPP-2008-0802) opened in December 2008. Debacarb is a fungicide registered to control diseases in ornamental trees, and is applied via injection into the tree trunk. Because of its limited use and potential exposure, the Agency did not conduct a new human health risk assessment during registration review. There are very little data on adverse effects and potential routes of exposure for wildlife and the environment, so the Agency conducted a qualitative ecological risk assessment. The Agency concluded that debacarb does not pose risk concerns for birds, mammals, and plants (both listed and non-listed). Risk could not be precluded for aquatic organisms (from leaf drop into aquatic habitats) and pollinators (from residues in pollen and nectar). To address these concerns, the Agency proposed prohibitions on treating trees within 20' of water bodies and before and during bloom. More recently, in characterizing exposure, the Agency determined that the pathway from treatment of leaves to receiving waters diluted the potential for adverse effects in aquatic organisms. Concerns about pollinator risks remain, and the Agency is directing the registrant to amend labels to prohibit application before and during bloom. The Agency will likely require pollinator data at a later time. Debacarb has not been evaluated under the Endocrine Disruptor Screening Program (EDSP).

Gas Cartridges; Inorganic Nitrate—Nitrite, Carbon and Carbon Dioxide, and Sulfur (Interim Decision). Potassium and sodium nitrate, carbon and carbon dioxide, and sulfur are ingredients in fumigant gas cartridge products, which are available in small and large sizes. Both sizes are registered to control burrowing mammals, but only the large gas cartridge is registered to also control coyotes, red foxes and skunks. Gas cartridges are registered for outdoor use only. To use the products, the user lights the fuse, places the cartridge in the burrow or den and seals the entrance. Animals within the burrow or den are asphyxiated by the release of carbon dioxide and toxic gases.

The Agency relied on a previous human health risk assessment in making its registration review decisions and determined that no human health risks of concern exist for these compounds. The Agency conducted a new ecological risk assessment for the gas cartridges for registration review. The risk assessment did find the potential for adverse effects to a number of listed species from gas cartridge use. EPA developed mitigation to address the risk to a number of listed species. In most cases, the mitigation involves the use of Endangered Species Protection Bulletins. Because the gas cartridges may contain up to three different active ingredients compounds, these Bulletins are available in the Inorganic Nitrate—Nitrite, Carbon and Carbon Dioxide, and Sulfur Registration Review dockets (EPA-HQ-OPP-2007-1118, EPA-HQ-OPP-2007-0705, and EPA-HQ-OPP-2008-0176, respectively). Although implementation of these Bulletins will address risk to some listed species from gas cartridge use, risk to a number of other listed species remains. Additionally, potassium and sodium nitrate, carbon and carbon dioxide, and sulfur have not been evaluated under the Endocrine Disruptor Screening Program (EDSP). Therefore, the Agency's final registration review decisions are dependent upon the result of ESA Section 7 consultation with the U.S. Fish and Wildlife Service (USFWS) and the evaluation of potential endocrine disruptor risk.

Maleic Hydrazide (Interim Decision). The registration review docket for maleic hydrazide (EPA-HQ-OPP-2009-0387) opened in September 2009. Maleic hydrazide is a systemic plant growth regulator registered for use on tobacco, potato, onions, non-bearing citrus, turf, utility and highway rights-of-way, airports, industrial land, lawns, recreational areas, ornamental/shade trees and ornamental plants. EPA published human health and ecological risk assessments in July 2014, which included a screening-level listed species assessment. No human health risks of concern were identified. The ecological risk assessment indicated potential risks to non-target terrestrial birds, terrestrial invertebrates, and certain species of semi-aquatic and terrestrial monocotyledonous plants. To address findings of the maleic hydrazide registration review, the Agency is reducing maximum application rates for certain uses, requiring additional data on chronic avian effects, and requiring label clarifications. Maleic hydrazide has not been evaluated under the EDSP nor has the EPA completed an ESA section 7 consultation with the USFWS and the National Marine and Fisheries Service (the Services). Therefore, the Agency's final registration review decision is dependent upon the result of the evaluation of potential endocrine disruptor risk and consultation with the Services for potential risk to listed species.

Soap Salts (Interim Decision). The registration review docket for soap salts (EPA-HQ-OPP-2008-0519) opened in September 2008. Soap salts are used as acaricides, herbicides, and insecticides on food and non-food crops in various settings, chiefly residential and agricultural. Ammonium and sodium soap salts are also used as animal repellants. EPA published draft human health and ecological risk assessments in March 2013 for a 60-day public comment period. In March 2015, EPA published a revised ecological risk assessment and the Soap Salts Proposed Interim Registration Review Decision for a 60-day public comment period. In this Soap Salts 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. The Agency's final registration review decision for soap salts will depend upon the results of an ESA section 7 consultation with the services, an EDSP determination, and an assessment of the non-target exposure to bees.

Sulfur (Interim Decision). The registration review docket for sulfur (EPA-HQ-OPP-2008-0176) opened in March 2008. Sulfur is used as an insecticide and fungicide on a wide range of field and greenhouse-grown food and feed crops, livestock, livestock quarters, and indoor and outdoor residential sites. Sulfur is also registered for use in gas cartridge products, along with inorganic nitrate/nitrite, carbon, and carbon dioxide. EPA has conducted a qualitative assessment for both human health and ecological risks, including listed species, for sulfur. Details of the assessment for the gas cartridge use are summarized under the gas cartridge heading in this unit. For uses of sulfur other than gas cartridges, the Agency is making a “no effect” determination for all listed aquatic species, and a “no effect” determination for direct effects to listed terrestrial vertebrates that do not rely on insects as a primary food source. However, at this time, the Agency is not able to make a listed species determination for effects to terrestrial invertebrates, terrestrial plants, or indirect effects to terrestrial vertebrates with insects as a primary food source. Sulfur has not been evaluated under the EDSP. Therefore, the Agency's final registration review decision is dependent upon the result of an ESA Section 7 consultation with the USFWS and the evaluation of potential endocrine disruptor risk.

Case Closure for Flufenpyr-ethyl (PC Code 108853; Case 7262). Flufenpyr-ethyl is an herbicide which was labeled for post-emergence control of broadleaf weeds in field corn, soybeans, and sugarcane. On March 19, 2015, the Agency received a request for voluntary cancellation of flufenpyr-ethyl from the technical and end-use product registrant, Valent USA Corporation. EPA subsequently issued a Federal Register notice announcing receipt of the request (FRL-9928-54) on July 8, 2015 (80 FR 39100), and allowed for a 30-day period for public comment on the request. No comments were received, and on September 22, 2015, EPA issued the cancellation order terminating the last pesticide products containing flufenpyr-ethyl registered in the United States (80 FR 57179) (FRL-9933-58). There were no existing stocks of these products and no requests for existing stocks provisions. Therefore no existing stocks provision was provided for these product registrations. With the cancellation of these remaining products, the Agency is announcing the closure of the registration review case for flufenpyr-ethyl.

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 dockets describe the Agency's rationale for issuing registration review interim decisions for these pesticides.

In addition to the interim registration review decision documents, 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 previously posted to each 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 decisions 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 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: September 30, 2015.

Bernard P. Keigwin, Jr.,

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