2 twenty-seven Section 24(c) (SLN ) labels, EFED had concerns fo r the potential short-term and long-term environmental exposure to non-target or ganisms. Additional labe l clarifications and restrictions, as well as any info rmation 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 Depa rtment of Agriculture, APHIS/USDA):

APHIS/USDA comment: During the last 11 years (2001 – 2011), the sole distributor of APHIS-registered Starlicide pr oducts (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 informati on on total and annual aver age sales of Starlicide products.

EFED response: Because of the unique usage profile of St arlicide 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 Secti on 24(c) labels EFED included in the Problem Formulation document (DPBarcode D389202), Star licide was reported sold by APHIS only sold under 19 of those labels in the last 11 years, su ggesting 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 provi des information on the geographical distribution of APHIS use, quantities used, re sources 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 Regi stration Review docket:

• APHIS will submit amended labels to addres s EPA’s concerns about the potential risk of accidental exposure of children and livestock. • APHIS will work jointly with Virbac to de velop 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 re vised labels and da ta waiver requests as they are submitted to the Agency. After extensiv e review of the five Section 3 labels and the twenty-seven Section 24(c) (SLN ) labels, EFED had concerns fo r the potential short-term and long-term environmental exposure to non-target or ganisms. Additional labe l clarifications and restrictions, as well as any info rmation presented in the waiver requests, may help to reduce

these concerns.

EPA-HQ-OPP-2011-0696-0010 from Aryenish Bird ie 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 LD 50 for S. vulgaris was greater than 1000 mg/kg bw. We recommend that the Agency further investig ate this study and use data from existing studies rather than3 conducting additional animal tests. The citati on 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 Marc h 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 prov ided report to complete a data review and for quantitative use in our risk assessments. Registra nts 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 classifi ed as “Quantitative” according to our guidance to evaluate acute risks to passerines.