Docket Number EPA-HQ-OPP-2011-0696 

www.regulations.gov 

Starlicide Final Work Plan 

Registration Review 

March 2012 

 

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FINAL WORK PLAN – STARLICIDE

Introduction: 

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of starlicide. The FWP includes the expected registration review 

timeline. The FWP also addresses any public comments received on the Preliminary Work Plan 

(PWP) in the Summary Document, which was posted in the starlicide registration review docket 

(EPA-HQ-OPP-2011-0696). The Summary Document, dated September 16, 2011, provided 

information on what EPA knows about the pesticide and what additional risk analyses and data 

or information the Agency believes are needed to make a registration review decision. 

The Agency’s implementation of the registration review program requires review of each 

registered pesticide every 15 years to determine whether it continues to meet the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. Changes in 

science, public policy, and pesticide use practices occur over time. The registration review 

program is intended to make sure that, as the ability to assess risk evolves and as policies and 

practices change, all registered pesticides continue to meet that statutory standard. The public 

phase of registration review begins when the initial docket is opened for each case. Information 

on this program is provided on the Agency’s website1

. 

Starlicide is an avicide registered for use to control ravens, starlings, crows, pigeons, cowbirds, 

grackles, blackbirds, magpies, and certain gull species. It is slow-acting and highly toxic to 

target species with death occurring one to three days after ingestion. Use sites vary by species 

and include livestock and poultry feedlots, buildings and fenced non-crop areas, federal and state 

wildlife refuges and protected areas, gull colonies in coastal areas, and bird staging areas and 

roosting sites. Starlicide is classified as a non-food use pesticide, and no tolerances are currently 

established. Starlicide products are restricted use pesticides, available for use only by certified 

applicators or persons under their direct supervision. There are currently no residential uses. 

Starlicide was first registered in 1967, and the Reregistration Eligibility Decision (RED) for 

Starlicide was completed in September 1995. 

Updates Since the Summary Document was Issued:

The Agency continues to work with PM Resources (a subsidiary of Virbac Corporation) and the 

United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), 

the registrants of starlicide products, to revise product labels to include language that is 

sufficiently restrictive to preclude exposure to livestock and members of the general public, 

particularly children and pets. Once appropriate language has been developed, EPA expects that 

all FIFRA Section 3 and 24c product labels will be amended accordingly. In addition, PM 

Resources and APHIS plan to submit information that may satisfy identified data needs or justify 

why data are not needed for the registration review of starlicide. Upon receipt and review of this 

information, EPA will determine any impacts on the planned risk assessments and data needs. If 

changes are made to the work plan, data requirements, or timeline, the Agency will amend the 

FWP and announce this amendment in the Federal Register. 

 

1

 http://www.epa.gov/oppsrrd1/registration_review/ 
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Summary of Comments and Agency Responses:

During the public comment period on the Starlicide Summary Document, which began on 

September 30, 2011 and ended on November 29, 2011, the Agency received three public 

comments. Comments were submitted by the Physicians Committee for Responsible Medicine 

(PCRM) and the two starlicide registrants, PM Resources and APHIS. The comments do not 

address the timeline described in the PWP, but they do address the planned ecological and 

human health risk assessments and data requirements. In the PWP, EPA also solicited comments 

on the specific topics of environmental justice, water body impairment, and trade irritants, but no 

comments or information were received on those issues. The submitted comments and EPA’s 

responses are summarized below. 

For additional details regarding EPA’s responses, please refer to the documents “EFED 

Response to Comments on Registration Review: Preliminary Problem Formulation for 

Starlicide,” dated February 9, 2012 and “Starlicide: Response to Comments on the Human 

Health Risk Scoping Document in Support of Registration Review,” dated January 31, 2012 

included in the starlicide registration review docket (EPA-OPP-2011-0696). 

Comments submitted by PM Resources (a subsidiary of Virbac Corporation) in EPA-HQOPP-2011-0696-0008 and comments submitted by the United States Department of 

Agriculture, Animal and Plant Health Inspection Service (APHIS) in EPA-HQ-OPP-2011-

0696-0009. 

Note: Due to the substantial similarity in public comments received from PM Resources and 

APHIS, the two registrants of starlicide products, the comments have been combined and 

summarized below to avoid repetition.

1. Comment: PM Resources is working with APHIS to revise and submit amended labels to 

address concerns about potential exposures to children and livestock. Furthermore, PM 

Resources and APHIS are working to develop waiver requests for the 24 anticipated data 

requirements listed in the Preliminary Work Plan. Due to the coordination and time needed 

to develop these documents, PM Resources and APHIS anticipate submitting information to 

EPA by February 29, 2012.

APHIS estimated that the cost of the anticipated data requirements is $2.3 million, and PM 

Resources, the technical registrant, stated that the low sales and usage of starlicide may not 

support such a substantial financial investment. PM Resources plans to review the industry 

needs for starlicide products along with the costs of their continued registration and to 

prepare potential data waiver requests. Additionally, APHIS believes that the oversight 

maintained over the use of starlicide products (certified applicators only, pre-baiting 

assessment, and site-specific tailoring), the limited use patterns, and minor use / low volume 

limit starlicide’s potential for long-term environmental and human health exposures and do 

not trigger the need for the new data requirements proposed in the Preliminary Work Plan.

Response: The Agency appreciates your sharing of these plans, and once submitted, EPA 

will consider any additional information, waiver requests, and label amendments that could 

limit or more clearly define use of starlicide. If anticipated submissions support altering the 
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registration review data requirements, the Final Work Plan may be amended in the future, as 

needed. The Agency will consider any submitted waiver requests on a case-by-case basis 

and will make every effort to minimize data requirements as warranted based on anticipated 

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

The Agency understands PM Resources’ and APHIS’s perspective on study costs along with 

the specialized use pattern of starlicide products. However, additional data are needed to 

adequately assess potential human health and ecological risks from starlicide use. Based on 

EPA’s review of the current Section 3 and 24c product labels, the Agency needs further 

information regarding the potential short and long-term environmental exposure to non-target 

organisms as well as occupational and non-occupational exposures to workers and the public. 

Additional label clarification and restrictions, as well as information presented in the 

anticipated waiver requests, may help to reduce these uncertainties. 

Comments submitted by the Physicians Committee for Responsible Medicine (PCRM) in 

EPA-HQ-OPP-2011-0696-0010. 

2. Comment: PCRM noted that there is a European study which may potentially be able to 

fulfill EPA’s data requirement for an avian acute oral toxicity study (GDLN 850.2100), and 

they recommended that EPA further investigate using data from that study rather than 

conducting a new study.

Response: The Agency appreciates the data source for the S. vulgaris (European starling)

toxicity data. However, in order to use this study quantitatively in a risk assessment, EPA 

would need the raw data and additional details about the conduct of the study. Registrants 

and the public are welcome to submit data for EPA review that could potentially be used to 

meet the guideline requirement for 850.2100. EPA will also use any relevant open literature 

that is classified as “Quantitative” according to our guidance to evaluate acute risks to 

passerines. 

3. Comment: PCRM stated that an acute inhalation toxicity study (GDLN 870.1300) has 

already been conducted, and they encouraged EPA to use this data to avoid conducting a 

new acute inhalation study.

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, this study 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), an adequate open literature study, or submission of a new study. 

4. Comment: PCRM stated that the prenatal developmental toxicity study (GDLN 870.3700) 

and the reproduction and fertility effects study (GDLN 870.3800) could be combined using 

OECD TG 443 extended one-generation reproductive toxicity study, and this would reduce 

the number of animals needed to conduct the studies.
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Response: The Agency appreciates PCRM’s recommendation for streamlining data 

requirements and will consider allowing use of OECD TG 443 if proposed by the registrants. 

Risk Assessment and Data Needs:

The Agency will require data and conduct a comprehensive ecological risk assessment, including 

an endangered species assessment, for all uses of starlicide. For human health, EPA will require 

data and conduct a revised occupational risk assessment during registration review. If 

toxicological endpoints or points of departure are revised based on the data that will be required 

for registration review, they will be considered in the new assessment, as well as any changes to 

the standard operating procedures or default exposure assumptions. Below is a summary of the 

issues relevant to the registration review of starlicide. 

Ecological Risk: 

 The ecological risk assessment in support of the starlicide RED was completed in 1995. 

Since the RED, the Agency has conducted several risk assessments for new FIFRA 

Section 3, Section 24c, and Section 18 uses of starlicide. 

 An updated comprehensive ecological risk assessment of all registered uses of starlicide 

will be conducted during registration review. The new assessment will incorporate the 

most up-to-date modeling methodologies, updated toxicological endpoints, and data 

submitted under the registration review data call-in. 

 A risk assessment that supports a complete endangered species determination has not 

been conducted for starlicide. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether starlicides’s use has “no effect” or 

“may affect” federally listed threatened or endangered species (listed species) or their 

designated critical habitats. When an assessment concludes that a pesticide’s use “may 

affect” a listed species or its designated critical habitat, the Agency will consult with the 

U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), 

as appropriate. 

 Data gaps exist in the environmental fate and toxicity databases for starlicide. EPA will 

require the following studies for use in conducting a complete ecological risk assessment, 

including an endangered species assessment, for the registration review of starlicide. 

Environmental Fate Guidelines: 

835.1230 – Adsorption / desorption 

835.1240 – Soil column leaching 

835.2410 – Photodegradation in soil 

835.4100 – Aerobic soil metabolism 

835.4300 – Aerobic aquatic metabolism 

835.4400 – Anaerobic aquatic metabolism 

835.6100 – Terrestrial field dissipation with an environmental chemistry analytical 

method and independent laboratory validation (ILV) for soil 
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835.6200 (footnote 7) – Aquatic field dissipation study2

Ecotoxicological Guidelines: 

850.1025 – Acute toxicity estuarine and marine organisms (oyster shell growth) 

850.1035 – Acute toxicity estuarine and marine organisms (mysid) 

850.1075 – Acute toxicity estuarine and marine organisms (one species of saltwater 

fish) 

850.1300 – Aquatic invertebrate lifecycle, freshwater (daphnid)

850.2100 – Avian oral toxicity (passerine species)

850.2300 – Avian reproduction (two species) 

850.4100 – Terrestrial plant toxicity, seedling emergence, Tier II 

850.4400 – Aquatic plant growth, vascular plants Tier II 

850.5400 – Aquatic plant growth, algae Tier II 

Non-guideline – Honeybee acute oral 

 Aquatic toxicity data will be required to quantitatively assess risk to aquatic organisms, 

due to potential offsite runoff and risk to endangered species. 

 Please refer to the September 1, 2011 document EFED Registration Review: Preliminary 

Problem Formulation for Starlicide in the registration review docket (EPA-HQ-OPP2011-0696) for a detailed discussion of the anticipated risk assessment and data needs. 

Human Health Risk:

 The most recent comprehensive human health risk assessment for starlicide was 

conducted in July 1995 in support of the starlicide RED. 

 Provided that product labels are amended as discussed with starlicide registrants, a 

dietary (food) exposure assessment will not be conducted during registration review 

because there are currently no registered food or feed uses for starlicide. Dietary 

exposure is not expected based on registered uses. If product labels are not amended, 

additional toxicity and residue data, and a dietary risk assessment would be required. 

 A drinking water dietary assessment for starlicide will not be conducted during 

registration review because there are no tolerances for starlicide, and thus, a human 

dietary risk assessment is not required. Moreover, given the limited use pattern of 

starlicide and label restrictions that prohibit placing treated baits near water bodies, a 

drinking water assessment is not needed.

 There are no residential uses and no anticipated residential exposures from starlicide. 

Provided that product labels are amended as discussed with starlicide registrants, 

residential handler and post-application exposure assessments will not be conducted 

 

2

 See footnote 7 of 40 CFR 150.1300. EPA will require only the environmental chemistry analytical methods and 

ILV portions of this guideline for water. 
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during registration review. If product labels are not amended, residential exposures will 

be assessed. 

 Starlicide’s occupational exposure assessment will be revised during registration review 

to include a quantitative assessment of exposures to occupational handlers and workers 

re-entering treated sites. 

 EPA will require the following data for use in reevaluating and updating the human 

health toxicity profile for the registration review of starlicide: 

870.1300 – Acute inhalation toxicity - rat 

870.3250 – 90-day dermal toxicity 

870.3700 – Prenatal developmental toxicity 

870.3800 – Reproduction and fertility effects 

870.6200 – Acute and subchronic neurotoxicity battery 

870.7800 – Immunotoxicity 

 Please refer to the August 31, 2011 document Starlicide: Human Health Risk Scoping 

Document in Support of Registration Review in the registration review docket (EPA-HQOPP-2011-0696) for a detailed discussion of the anticipated risk assessments and data 

needs. 

Endocrine Disruptor Screening Program: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its reregistration decision, EPA reviewed these data and selected 

the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard 

database. However, as required by FFDCA section 408(p), starlicide is subject to the endocrine 

screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 
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establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Starlicide is 

not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for starlicide. For further information on 

the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/. 

Timeline:

EPA has created the following estimated timeline for the completion of starlicide’s registration 

review. 

Registration Review for Starlicide – Projected Registration Review Timeline

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period Sept. 2011 - Completed 

Close Public Comment Nov. 2011 - Completed 

Case Development 

Final Work Plan March 2012 – Completed 

Issue DCI 2012 – Oct. – Dec. 

Data Submission 2016 – Oct. – Dec. 

Open Public Comment Period for Draft Risk Assessments 2018 – April – June 

Close Public Comment Period 2018 – July – Sept. 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

 2018 – Oct. – Dec. 

Close Public Comment Period 2019 – Jan. – March 

Registration Review Decision and Begin Post-Decision Follow-up 2019 

Total (years) 8 

Next Steps: 

EPA will continue discussions with PM Resources and APHIS to revise starlicide product labels 

to reflect actual usage patterns. These efforts are currently underway, but it is expected to take 

additional time for label language to be developed, submitted to EPA, and approved by the 

Office of Pesticide Programs’ Registration Division. If additional information provided by the 

registrants changes the expected registration review risk assessments, data requirements, or 

timeline, the FWP will be amended and announced in a Federal Register notice. 

As noted previously, the Agency will require several environmental fate, ecological effects, and 

human health studies through a data call-in, expected to be issued in late 2012. This new 

information will be used to conduct complete risk assessments for all starlicide uses. 
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SUMMARY OF DATA GAPS – STARLICIDE 

The table below summarizes all data needs for starlicide in Section I of this document, EFED 

Registration Review: Preliminary Problem Formulation for Starlicide dated September 1, 2011, 

and the Starlicide: Human Health Risk Scoping Document in Support of Registration Review

dated August 31, 2011. 

Table 1. Data Needs for Starlicide Registration Review 

Guideline 

Number Data Needs Test 

Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

835.1230 Adsorption / desorption 3 TGAI 12 

835.1240 Soil column leaching3 TGAI 12 

835.2410 Photodegradation in soil TGAI 12 

835.4100 Aerobic soil metabolism4 TGAI 24 

835.4300 Aerobic aquatic metabolism TGAI 24 

835.4400 Anaerobic aquatic metabolism TGAI 24 

835.6100 Terrestrial field dissipation with an environmental 

chemistry analytical method and ILV for soil5 TEP 24 

835.6200 Aquatic field dissipation study6 TGAI 12 

850.1025 Acute toxicity estuarine and marine organisms (oyster 

shell growth) TGAI 12 

850.1035 Acute toxicity estuarine and marine organisms 

(mysid) TGAI 12 

850.1075 Acute toxicity estuarine and marine organisms (one 

species of saltwater fish) TGAI 12 

850.1300 Aquatic invertebrate lifecycle, freshwater (daphnid) TGAI 12 

850.2100 Avian oral toxicity (passerine species) TGAI 12 

850.2300 Avian reproduction (upland game bird and waterfowl) TGAI 24 

850.4100 Terrestrial plant toxicity, seedling emergence, Tier II7 TEP 12 

 

3

 Either the soil column leaching or the adsorption / desorption study will be required to satisfy the mobility data 

requirement. The adsorption / desorption study is preferred, but the soil column leaching study can be used when a 

pesticide degrades too rapidly to be measured by a batch equilibrium study. 

4

 Four soils will be required to support this data requirement. 

5

 A terrestrial field dissipation study is required to support outdoor uses. However, feeding or efficacy studies which 

track the rate of consumption of bait and show that most of the bait is consumed by the target species can be 

submitted to support a waiver of the field dissipation requirement. If the full terrestrial field dissipation study is 

waived, EPA will require only the environmental chemistry analytical methods and ILV portions of this guideline 

for soil, per footnote 7 of 40 CFR 150.1300. 

6

 See footnote 7 of 40 CFR 150.1300. EPA will require only the environmental chemistry analytical methods and 

ILV portions of this guideline for water. 

7

 The DCI will provide that a Tier I plant study may be conducted in lieu of a Tier II study with the understanding 

that any adverse effects observed by the Tier I study would necessitate conduct and submission of a Tier II study as 

well. 
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Table 1. Data Needs for Starlicide Registration Review 

Guideline 

Number Data Needs Test 

Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

850.4400 Aquatic plant growth, vascular plants Tier II for 

Lemna spp.7 TGAI 12 

850.5400 Aquatic plant growth, algae Tier II with 4 species7 TGAI 12 

Nonguideline Honeybee acute oral TGAI 12 

870.1300 Acute inhalation toxicity - rat TGAI 8 

870.3250 90-day dermal toxicity8 TGAI 24 

870.3700 Prenatal developmental toxicity TGAI 24 

870.3800 Reproduction and fertility effects TGAI 48 

870.6200 Acute and subchronic neurotoxicity battery TGAI 24 

870.7800 Immunotoxicity TGAI 12 

 

 

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 Based on the registered use patterns, a 28-day dermal toxicity study would be acceptable in lieu of the guideline 

90-day study.