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1) Comment: PCRM – The Summary Document indicates that the Agency may request 

testing for acute inhalation toxicity. According to the Hazardous 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 provided in NTP study. 

HED Response: The registrant should submit any existing acute inhalation data, 

including derivation of an LC50 based on the available data, to the Agency for review. 

Since EPA does not currently have an acceptable 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 fulfilled 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 allowing 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 children 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 about potential exposure to livestock, children and pets. It is 

important to note that the Section 18 Special Local Needs labels also need to be similarly 

revised. 

4) Comment: APHIS – PM Resources, Inc., a subsidiary of Virbac Corporation 

(Virbac), is the registrant of the starlicide technical-grade active ingredient. 

Consequently, all new starlicide data submissions 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 starlicide 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 every 
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effort to minimize toxicological data requirements as warranted based on anticipated 

exposure and use patterns as reflected by labeled directions for use. 

5) Comment: Virbac – Virbac will continue to work with APHIS to prepare 

justifications for and submit requests for waivers for data requirements. The data waiver 

requests will provide more detailed information on each of the studies requested. 

HED Response: As noted, Agency will review submitted 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.