[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Pages 62069-62071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26299]



[EPA-HQ-OPP-2015-0393; FRL-9934-06]

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: 
(703) 308-8015; email address: [email protected].


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 

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 (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. 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                                                         Contact and contact
                 No.                                     Docket ID No.                          information
Carbon and Carbon Dioxide (Case       EPA-HQ-OPP-2007-0705..............................  James Parker, (703)
 4019).                                                                                    306-0469,
                                                                                           [email protected].

[[Page 62070]]

Debacarb (2-EEEBC) (Case 4031)......  EPA-HQ-OPP-2008-0802..............................  Roy Johnson, (703) 347-
                                                                                           [email protected].
Flufenpyr-ethyl (Case 7262).........  EPA-HQ-OPP-2014-0768..............................  Tracy Perry, (703) 308-
                                                                                           [email protected].
Inorganic Nitrate-Nitrite (Case       EPA-HQ-OPP-2007-1118..............................  Brittany Pruitt, (703)
 4052).                                                                                    347-0289,
                                                                                           [email protected].
Maleic Hydrazide (Case 0381)........  EPA-HQ-OPP-2009-0387..............................  Ricardo Jones, (703)
                                                                                           [email protected]
Soap Salts (Case 4083)..............  EPA-HQ-OPP-2008-0519..............................  Tracy Perry, (703) 308-
                                                                                           [email protected].
Sulfur (Case 0031)..................  EPA-HQ-OPP-2008-0176..............................  Jose Gayoso, (703) 347-
                                                                                           [email protected].

    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 
    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

[[Page 62071]]

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-
    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: 

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

    Dated: September 30, 2015.
Bernard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
[FR Doc. 2015-26299 Filed 10-14-15; 8:45 am]