Page 2 of 3 1) Comment: PCRM – The Summary Document indicates that the Agency may request testing for acute inhalation t oxicity. According to the Hazar dous Substances Data Bank and the testing status of agents at NTP an acute inhalation study has already been conducted. We encourage the Agency to see if they can derive an LC50 to avoid conducting an additional acute inhalation study based on data pr ovided in NTP study.

HED Response: The registrant should submit any existing acute inhalation data, including derivation of an LC50 based on the av ailable data, to the Agency for review. Since EPA does not currently have an acceptabl e acute inhalation study in its database, Guideline 870.1300, acute inhalation toxicity, will remain on the list of data needs to be called-in. The data requirement can be fu lfilled by various methods including submission of a previously conducted study (if reviewed and found to be acceptable) or submission of a new study.

2) Comment: PCRM – With respect to the Prenatal Developmental Toxicity and the Reproduction and Fertility Effects studies we recommend that both studies be combined using the OECD TG 443 Extended One- Generation Reproductive Toxicity Study (EOGRTS). This will allow the registrants to conduct one combined rat study saving many animals ’ lives. The TG is currently available on the OCED website.

HED Response: The Agency appreciates PCRM’s recommendation for streamlining data requirements and will consider allowi ng use of the EOGRTS if proposed by the registrants.

3) Comment: APHIS – APHIS will submit revised labels amending the Precautionary Statements on each of our Section 3 labels with proposed language intended to ensure maximum protection of ch ildren and livestock.

HED Response: The Agency appreciates APHIS’ plans to clarify, tighten, and

standardize restrictions aimed at protecting human health and safety for labels registered by USDA APHIS. EPA will work with APHIS to ensure that the labels are adequately

revised to address concerns a bout potential exposure to livestoc k, children and pets. It is important to note that the Section 18 Special Lo cal Needs labels also need to be similarly

revised.

4) Comment: APHIS – PM Resources, Inc., a subs idiary of Virbac Corporation (Virbac), is the registrant of the starli cide technical-grade active ingredient. Consequently, all new starlicide data submi ssions or waiver requests will have to be submitted to EPA by Virbac. However, APHIS plans to work with Virbac to develop waiver requests for the data proposed in the Summary Document. In general, waiver requests will rely on the use restrictions in amended labels and limited use patterns as

described in APHIS comments.

HED Response: OPP’s data requirements for starli cide are based on requirements for non-food use pesticides established under 40 CFR Part 158. However, the Agency will consider any submitted waiver requests on a case-by-case basis and will make everyPage 3 of 3 effort to minimize toxicological data requi rements as warranted based on anticipated exposure and use patterns as reflecte d by labeled directions for use.

5) Comment: Virbac – Virbac will con tinue to work with APHIS to prepare justifications for and submit requests for waiver s for data requirements. The data waiver requests will provide more detailed inform ation on each of the studies requested.

HED Response: As noted, Agency will review subm itted data waiver requests and will consider reducing data requirements on a case-by-case basis based on the detailed information provided and labeled directions for use.