Docket Number EPA-HQ-OPP-2011-0696 

www.regulations.gov 

Starlicide Summary Document 

Registration Review: Initial Docket 

September 2011 

 

3

TABLE OF CONTENTS 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 11 

III. Summary of Data Gaps 16 

__________________________________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. EFED Registration Review: Preliminary Problem Formulation for Starlicide. C. Hartless. 

September 1, 2011. 

2. Starlicide: Human Health Risk Scoping Document in Support of Registration Review. B. 

Daiss. August 31, 2011. 

3. BEAD Chemical Profile for Registration Review: Starlicide (Chemical Code 009901). M. 

Kaul. March 31, 2011. 

4. Starlicide Appendix A. January 4, 2011.

5. Starlicide Review of Human Incidents. S. Recore. May 17, 2011. 

These and other supporting documents for the starlicide registration review case may be found in 

the docket EPA-HQ-OPP-2011-0696 at http://www.regulations.gov.
4

I. PRELIMINARY WORK PLAN – STARLICIDE

Introduction: 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. 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 the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at: http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

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

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of starlicide. 

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, and 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. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to require data and to conduct a comprehensive ecological risk 

assessment, including an endangered species assessment, for all uses of starlicide. For human 

health, EPA anticipates the need to require data and to conduct a revised occupational risk 

assessment during registration review. If toxicological endpoints or points of departure are 

revised based on the data that are anticipated to be required for registration review, they will be 

considered in the new assessment, as well as any changes to the standard operating procedures or 
5

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 anticipated 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 

anticipates requiring 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 – Soil column leaching 

835.1240 – Adsorption / desorption 

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 

835.6200 – Environmental chemistry analytical methods and ILV for water 

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)
6

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 are anticipated to be required to quantitatively assess risk to aquatic 

organisms due to offsite runoff and so risk to endangered species is not presumed. 

 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 is not anticipated to be needed 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. See 

the Recent Actions section of the Fact Sheet for further detail.

 A drinking water dietary assessment for starlicide is not anticipated during registration 

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

assessment is not anticipated. 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 expected to be 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 are not anticipated to be 

needed during registration review. If product labels are not amended, a residential 

exposure assessment would be required. See the Recent Actions section of the Fact Sheet 

for further detail. 

 Starlicide’s occupational exposure assessment needs to be revised during registration 

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

workers re-entering treated sites. 

 EPA anticipates the need to require the following data for use in reevaluating and 

updating the human health toxicity profile for the registration review of starlicide: 
7

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 

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/. 
8

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 2011 – September 

Close Public Comment 2011 – November 

Case Development 

Final Work Plan 2012 – February 

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 

Guidance for Commenters: 

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the starlicide case. 

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Because starlicide is not registered for food/feed uses in the U.S., it has no U.S. tolerances. 

Water Quality: 

Starlicide is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act1. In addition, no Total Maximum Daily Loads (TMDL) 

 

1 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885
9

have been developed for starlicide2

. More information on impaired water bodies and TMDLs 

can be found at the Agency’s website3

. The Agency invites submission of water quality data for 

this pesticide. To the extent possible, data should conform to the quality standards in Appendix 

A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other

Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process4

 in 

order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to starlicide compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population. 

Other Information: 

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining the risk assessments, including any species-specific ecological 

determinations. The Agency is interested in obtaining the following information: 

1. confirmation on the following label information 

a. sites of application 

b. formulations 

c. application methods and equipment 

d. maximum application rates 

e. frequency of application, application intervals, and maximum number of 

applications per season 

f. geographic limitations on use 

2. use or potential use distribution (e.g., acreage and geographical distribution of relevant 

use sites) 

3. use history 

4. median and 90th percentile reported use rates (lbs ai/1000 sq ft) from usage data – 

national, state, and county 

5. application timing (date of first application and application intervals) – national, state, 

and county 

6. sub-county use site location data 

7. usage/use information for non-agricultural uses 

8. directly acquired county-level usage data (not derived from state level data) 

a. maximum reported use rate (lbs ai/acre) from usage data – county 

 

2

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

3 http://www.epa.gov/owow/tmdl/

4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
10

b. median and 90th percentile number of applications – county 

c. total pounds per year – county 

d. the year the pesticide was last used in the county/sub-county area 

e. the years in which the pesticide was applied in the county/sub-county area 

9. typical application interval (days) 

10. state or local use restrictions 

11. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency 

12. monitoring data 

Next Steps: 

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of starlicide. 
11

II. FACT SHEET 

 

Background Information: 

 Starlicide registration review case number: 2610. 

 Starlicide PC code: 009901. 

 Starlicide CAS No.: 7745-89-3. 

 Starlicide was first registered for use in the United States in 1967.

 The starlicide RED was completed in September 1995.

 PM Resources is the registrant for the starlicide technical product and one of six end-use 

product registrations. USDA is the registrant for the five other end-use product 

registrations. As of August 17, 2011, there are 29 active state-specific Special Local 

Need (Section 24c) registrations. 

 All Section 3 products registered at the time of the RED have been reregistered. 

 Because there are no food or feed uses of starlicide, there are no tolerances established 

for this chemical. 

 Pesticide Re-evaluation Division, Chemical Review Manager: Monica Wait, 

wait.monica@epa.gov 

 Registration Division, Product Reviewer: Dan Peacock, peacock.dan@epa.gov

Use & Usage Information: (For additional details on label rates and use sites, refer to 

Starlicide Appendix A, January 4, 2011 and the BEAD Chemical Profile for Registration Review: 

Starlicide, March 31, 2011, in the registration review docket EPA-HQ-OPP-2011-0696.) 

 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 1 – 3 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. 

 All starlicide products are classified as restricted use pesticides and are to be used only by 

certified applicators or persons under their direct supervision. 

 There are no registered food or feed uses of starlicide, and there are no residential or 

homeowner uses. 

 Five of the six starlicide end-use products are formulated as soluble concentrates, which 

the applicator mixes with various types of baits (e.g., bread crumbs, rice, corn, dry dog 

food, poultry pellets). One end-use product, Starlicide Complete (EPA Reg # 67517-8), 

is formulated as a bait pellet. 

 Starlicide is applied by manual or mechanical broadcast of treated bait or by placement of 

treated bait in feeding stations. 
12

 EPA does not have a current nationwide estimate of starlicide usage and requests that the 

registrants provide this information during registration review. 

 Although dated, the 1995 starlicide RED estimated that national usage was approximately 

110 pounds of active ingredient per year. 

Recent Actions:

 In preparation of starlicide’s registration review, EPA conducted a review of current 

product labels. In order to maintain the “non-food use” classification for the use of 

starlicide in feedlots, the registrants have agreed to revise product labels to include 

language that is sufficiently restrictive to preclude exposure to livestock. Once this 

language has been developed, all FIFRA Section 3 and 24c product labels will be 

amended accordingly. 

Similarly, the registrants have agreed to revise product labels to include language that is 

sufficiently restrictive to preclude residential post-application exposure to the general 

public, particularly children. The registrants have indicated that starlicide products are 

intended to be used in areas not accessible to the general public. However, this needs to 

be clearly and consistently stated on all Section 3 and 24c product labels. Once this 

language has been developed, product labels will be amended accordingly. 

Ecological Risk Assessment Status:

Please refer to the EFED Registration Review: Preliminary Problem Formulation Starlicide, 

September 1, 2011 for a detailed discussion of the key findings of the most recent ecological risk 

assessments. A summary follows: 

 

Summary of Risks: 

 The most recent comprehensive ecological risk assessment for starlicide was completed 

in support of the 1995 starlicide RED. 

 Environmental risk conclusions included the following: non-target birds and mammals 

may be at risk from eating starlicide-treated bait (primary exposure), or as scavengers and 

predators, from consuming animals who have eaten treated baits (secondary exposure). 

The risk to primary non-target bird populations was considered high for all uses of 

starlicide, as was the risk to endangered small mammals in areas treated with the highest 

application rates. In addition, starlicide also posed acute risks to aquatic invertebrates. 

 Based on the environmental and human health risk estimates from the RED, the Agency 

specified risk reduction measures to mitigate human health and ecological risk concerns. 

These included lowering the application rates on all broadcast applications to 0.1 pounds 

active ingredient per acre; requiring pre-baiting to ensure rapid bait acceptance by target 

species; restricting the use of treated baits to at least 50 feet from bodies of water; and 

classifying all starlicide products as restricted use pesticides. 
13

 Since the RED was completed, EPA has conducted several ecological risk assessments 

for new uses of starlicide through Section 3 product registrations, special local need 

registrations, and emergency exemptions. Risk concerns were similar to those outlined in 

the RED. 

Human Health Risk Assessment Status: 

Please refer to Starlicide: Human Health Risk Scoping Document in Support of Registration 

Review, August 31, 2011 for a detailed discussion of the key findings of the most recent human 

health risk assessment. A summary follows: 

Hazard Characterization:

 Starlicide was determined to be a low volume, minor use pesticide for the 1995 risk 

assessment. The Agency waived the guideline requirements for repeat dose oral and 

dermal toxicity studies for starlicide due to low use and low exposure expected from the 

actively registered products. Consequently, there are a limited number of toxicological 

studies available for starlicide. 

 A non-guideline chronic cancer study conducted by the National Cancer Institute (NCI) 

with mice and rats indicates that starlicide is not a carcinogen. Available mutagenicity 

tests indicate that starlicide is not mutagenic. 

Dietary (Food and Drinking Water):

 The previous starlicide risk assessment designated registered uses of starlicide as nonfood with the stipulation that uses allowing application to areas where food or feed crops 

were grown be removed from existing labels and that labels be revised to include a 365-

day prohibition on grazing animals and growing crops on lands treated with starlicide 

baits. Under these conditions, a dietary exposure assessment was not required for the 

RED. 

 A quantitative drinking water assessment was also not required for the RED, based on 

limited use patterns and restrictions against placement of treated baits within 50 feet of 

water bodies. 

Residential (Non-occupational): 

 

 At the time of the RED the majority of starlicide products were classified as restricted use 

pesticides, limited to use only by certified applicators or persons under their direct 

supervision. Therefore, a residential handler exposure assessment was not conducted for 

the 1995 assessment. As a condition of reregistration, the RED required that the one 

starlicide product classified for general use be reclassified as restricted use, not for 

purchase or application by homeowners. 

 While the RED assessment indicated that there was potential exposure to residents 

entering treated sites after application, the Agency concluded that post-treatment 
14

residential exposures would be minimal based on use restrictions. Thus, a residential 

post-application exposure assessment was not conducted during the previous risk 

assessment. 

Aggregate: 

 An aggregate risk assessment typically evaluates the combined risk from dietary 

exposure (food plus drinking water) and any residential uses. An aggregate assessment 

was not conducted for the 1995 risk assessment since starlicide uses were determined to 

be non-food and residential exposures were qualitatively determined to be minimal and 

not of concern. 

Occupational:

 During the 1995 risk assessment, the Agency determined that a quantitative assessment 

of occupational handler and post-application exposure was not required based on the 

restricted use classification, use patterns that resulted in limited exposure, and 

requirements for use of personal protective equipment. 

Human Studies: 

 The previous starlicide risk assessment did not rely on data from studies in which adult 

human subjects were intentionally exposed to a pesticide or other chemical. 

Cumulative: 

 EPA has not yet determined whether or not starlicide shares a common mechanism of 

toxicity with other chemical substances. If the Agency determines that new information 

on starlicide is available that could potentially affect a cumulative risk assessment and 

result in a risk of concern, the Agency will revisit the need for a cumulative assessment. 

Incidents: 

 A review of the Ecological Incident Information System (EIIS), the ‘Aggregate Incident 

Reports’ (AIR) database, and the Avian Monitoring Information System (AIMS) for 

ecological incidents involving starlicide was completed on May 27, 2011. Two incidents 

were reported in EIIS, one incident was reported in AIMS, and no incidents were 

reported in AIR; the degree of certainty ranged between possible and probable. 

Mortalities of between 100 and 300 birds were reported for each incident; two incidents 

involved starlings and one involved cowbirds. The Agency acknowledges that these are 

target species for some starlicide products, and if information is available, these incidents 

will be discussed in further detail in the starlicide ecological risk assessment. 

 An updated human health incident report was conducted for starlicide for registration 

review. From 2006 to 2011, there were no incident cases reported for starlicide in either 

the main or aggregate Incident Data Systems. Based on the lack of reported incident 
15

cases, there does not appear to be a concern at this time that would warrant further 

investigation. 

Tolerances and International Harmonization: 

 Because there are no registered food or feed uses for starlicide, no tolerances are 

currently established. 

Data Call-In Status: 

 No generic data were required as a result of the 1995 starlicide RED, and thus, no generic 

data call-in (GDCI) was issued. 

Labels: 

 

 Registration numbers and labels for starlicide products can be obtained from the Pesticide 

Product Label System (PPLS) website5. 

 

5

 http://oaspub.epa.gov/pestlabl/ppls.home 
16

III. SUMMARY OF DATA GAPS – STARLICIDE 

The table below summarizes all anticipated 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. 

Guideline 

Number Anticipated Data Need Test 

Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

835.1230 Soil column leaching6 TGAI 12 

835.1240 Adsorption / desorption6 TGAI 12 

835.2410 Photodegradation in soil TGAI 12 

835.4100 Aerobic soil metabolism7 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 soil8 TEP 12 

835.6200 Environmental chemistry analytical methods and ILV 

for water9 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 

II10 TEP 12 

850.4400 Aquatic plant growth, vascular plants Tier II for 

Lemna gibba10

TGAI or 

TEP 12 

 

6

 Either the soil column leaching or the adsorption / desorption study is expected to 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. 7

 Four soils are expected to be required to support this data requirement. 8

 A terrestrial field dissipation study is expected to be 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 fulfillment of the field dissipation requirement. 9

 See footnote 7 of 40 CFR 150.1300. EPA anticipates requiring only the environmental chemistry analytical 

methods and ILV portions of this guideline for water. 10 The DCI expected to be issued 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. 
17

Guideline 

Number Anticipated Data Need Test 

Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

850.5400 Aquatic plant growth, algae Tier II with 4 species10 TGAI or 

TEP 12 

Nonguideline Honeybee acute oral TGAI 12 

870.1300 Acute inhalation toxicity - rat TGAI 8 

870.3250 90-day dermal toxicity 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