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twenty-seven Section 24(c) (SLN) labels, EFED had concerns for the potential short-term and 

long-term environmental exposure to non-target organisms. Additional label clarifications and 

restrictions, as well as any information presented in the waiver requests, may help to reduce 

these concerns. 

EPA-HQ-OPP-2011-0696-0009 from Kenneth R. Seeley (Animal and Plant Health 

Inspection Service United States Department of Agriculture, APHIS/USDA):

APHIS/USDA comment: During the last 11 years (2001 – 2011), the sole distributor of 

APHIS-registered Starlicide products (USDA APHIS WS Pocatello Supply Depot, Pocatello, ID) 

sold product under 24 different labels (5 FIFRA Section 3 labels and 19 Special Local Need 

(24(c)) labels). APHIS also provides information on total and annual average sales of Starlicide 

products. 

EFED response: Because of the unique usage profile of Starlicide and lack of available usage 

data, EFED appreciates the usage information that was provided in Table 1 of the submitted 

comment. Of the 27 currently registered Section 24(c) labels EFED included in the Problem 

Formulation document (DPBarcode D389202), Starlicide was reported sold by APHIS only sold 

under 19 of those labels in the last 11 years, suggesting label review and clarification would be 

beneficial. When submitted, EFED will review the additional data regarding use of Starlicide 

during this same 11-year time period that provides information on the geographical distribution 

of APHIS use, quantities used, resources protected, and the species we most frequently are asked 

to control. 

APHIS/USDA comment: APHIS has consulted with Virbac and EPA, and APHIS has decided 

to take the following actions to address issues raised by EPA in the Registration Review docket: 

• APHIS will submit amended labels to address EPA’s concerns about the potential risk 

of accidental exposure of children and livestock. 

• APHIS will work jointly with Virbac to develop data waiver requests for the 24 newlyproposed data requirements discussed in the Registration Review docket. 

APHIS anticipates this information will be submitted to the Agency by February 29, 2012. 

EFED response: EFED looks forward to reviewing the revised labels and data waiver requests 

as they are submitted to the Agency. After extensive review of the five Section 3 labels and the 

twenty-seven Section 24(c) (SLN) labels, EFED had concerns for the potential short-term and 

long-term environmental exposure to non-target organisms. Additional label clarifications and 

restrictions, as well as any information presented in the waiver requests, may help to reduce 

these concerns. 

EPA-HQ-OPP-2011-0696-0010 from Aryenish Birdie and Kristie Sullivan (Physicians 

Committee for Responsible Medicine, PCRM):

PCRM comment: The Summary Document indicates that the Agency may request testing for 

avian acute oral toxicity. A peer-reviewed study in the European Chemical Substances 

Information System provides data for Sturnus vulgaris (European starling), a passerine bird in 

the Sturnidae family. The LD50 for S. vulgaris was greater than 1000 mg/kg bw. We recommend 

that the Agency further investigate this study and use data from existing studies rather than 
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conducting additional animal tests. The citation for these data was given as: European 

Commission, ESIS; IUCLID Dataset, 3-Chloro-p-toluidine (95-74-9) p.11 (2000 CD-ROM 

edition). Available from, as of March 5, 2010: http://esis.jrc.ec.europa.eu. 

EFED response: EFED appreciates the data source for the S. vulgaris toxicity data; however, 

insufficient information is available in this provided report to complete a data review and for 

quantitative use in our risk assessments. Registrants and public are welcome to submit data for 

EFED review that could potentially be used to meet the guideline requirements. EFED will also 

use any relevant open literature that is classified as “Quantitative” according to our guidance to 

evaluate acute risks to passerines.