Docket Number EPA-HQ-OPP-2011-0696 www.regulations.gov



## Starlicide Summary Document Registration Review: Initial Docket September 20113 

### 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 su mmarize the Environmental Protection Agency's current position based on the following documents:

1. EFED Registration Review: Preliminar y 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 Re view: 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 starli cide 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 Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www. epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e 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 belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop 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 sp ecies. It is slow-act ing and highly toxic to target species with death occurr ing one to three days after inge stion. Use sites vary by species
and include livestock an d poultry feedlots, buildings and fen ced non-crop areas, federal and state wildlife refuges and protected ar eas, gull colonies in coastal ar eas, and bird staging areas and roosting sites. Starlicide is cl assified as a non-food use pesticide, and no tolerances are currently established. Starlicide products are restricted use pesticides, av ailable for use only by certified applicators or persons under thei r direct supervision, and there ar e currently no residential uses. Starlicide was first regi stered 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 endangere d species assessment, for all us es of starlicide. For human health, EPA anticipates the need to require da ta and to conduct a revised occupational risk assessment during registration review. If toxico logical endpoints or po ints 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 or5 default exposure assumptions. Below is a summar y of the issues releva nt 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 assessm ent of all registered uses of starlicide will be conducted during registration review. The new assessment will incorporate the most up-to-date modeling methodologies, upda ted toxicological e ndpoints, and data submitted under the anticipated regi stration review data call-in.

 A risk assessment that supports a complete endangered species determination has not been conducted for starlicide. The ecologica l 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 asse ssment concludes that a pesticide’s use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the
U.S. Fish and Wildlife Service and/or Nationa l 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 fo r use in conducting a complete ecological risk assessment, including an endangered sp ecies 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 laborator y validation (ILV) for soil 835.6200 – Environmental chemistry analyt ical methods and ILV for water

Ecotoxicological Guidelines:

850.1025 – Acute toxicity estuar ine and marine organism s (oyster shell growth) 850.1035 – Acute toxicity es tuarine and marine organisms (mysid) 850.1075 – Acute toxicity estuarin e 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, va scular plants Tier II 850.5400 – Aquatic plant growth, algae Tier II Non-guideline – Honeybee acute oral

 Aquatic toxicity data are anticipated to be re quired 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 an ticipated risk assessment and data needs.

Human Health Risk:

 The most recent comprehensive human heal th risk assessment for starlicide was conducted in July 1995 in suppor t of the starlicide RED.

 Provided that product labels are amended as discussed with starli cide registrants, a dietary (food) exposure assessment is not an ticipated to be need ed during registration review because there are currently no registered food or feed uses for starlicide. Dietary exposure is not expected base d on registered uses. If product labels are not amended, additional toxicity and residue data and a dietary risk asse ssment would be required. See

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

 A drinking water dietary assessment for starli cide is not anticipa ted during registration
review because there are no tolerances for starlicide, and thus, a human dietary risk assessment is not anticipated. Moreover, give n the limited use pattern of starlicide and label restrictions that prohibit placing trea ted baits near water bodies, a drinking water assessment is not expected to be needed.

 There are no residential uses and no anticipat ed residential exposures from starlicide. Provided that product labels are amended as discussed with starli cide registrants, residential handler and post-a pplication exposure assessments are not anticipated to be needed during registration review. If produc t labels are not amended, a residential exposure assessment would be required. See th e Recent Actions secti on of the Fact Sheet

for further detail.

 Starlicide’s occupational e xposure assessment needs to be revised during registration review to include a quantita tive 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 fo r the registration revi ew 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 th e anticipated risk assessments and data

needs.

Endocrine Disruptor Screening Program :

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its reregistration decision, EPA reviewed th ese 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 su bject to the endocrine screening part of the Endocrine Di sruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredients and 9 inert ingredients. Starlicide is not among the group of 58 pesticide active ingredient s on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for starli cide. For further information on the status of the EDSP, the policie s and procedures, the lis t 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 St arlicide – Projected Regi stration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Comm ent 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 Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade 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 na ture 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 Act 1 . 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=8859 have been developed for starlicide 2 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 3 . The Agency invites submission of water quality data for this pesticide. To the extent possible, data s hould conform to the qual ity standards in Appendix

A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Re view Risk Assessment and Management Process 4 in order to ensure they can be us ed quantitatively or qua litatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposur e to starlicide compared to th e general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to th e general population.

Other Information:

Stakeholders are also specifically asked to prov ide 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, applicati on intervals, and maximum number of applications per season

f. geographic limitations on use

2. use or potential use distribution ( e.g. , acreage and geographical di stribution of relevant use sites)

3. use history

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

5. application timing (date of firs t application and application in tervals) – 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 da ta (not derived from state level data)

a. maximum reported use rate (lbs a i/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.htm10 b. median and 90 th percentile number of applications – county

c. total pounds per year – county

d. the year the pesticide was last us ed 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 alr eady 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 i ssue a Final Work Plan for the registration
review of starlicide.11 

### II. FACT SHEET

Background Information :

 Starlicide registration re view case number: 2610.

 Starlicide PC code: 009901.

 Starlicide CAS N o.: 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 starlic ide technical product a nd one of six end-use product registrations. USDA is the regist rant 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 st arlicide, there are no tolerances established
for this chemical.

 Pesticide Re-evaluation Di vision, 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 fo r 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, star lings, crows, pigeons, cowbirds, grackles, blackbirds, magpies, and ce rtain 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 poul try feedlots, buildings and fenced non-crop areas, federal and state wildlife refuges and pr otected areas, gull colonies in coastal areas, and bird staging areas and roosting sites.

 All starlicide products are classi fied as restricted use pesticid es 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 e nd-use products are formulated as soluble concentrates, which the applicator mixes with va rious types of baits (e.g., brea d 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 th is information during registration review.

 Although dated, the 1995 starlicid e RED estimated that national usage was approximately 110 pounds of active ingredient per year.

Recent Actions :

 In preparation of starlicide’s registrati on 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 ag reed to revise product labels to include language that is sufficiently restrictive to preclude expos ure to livestock. Once this language has been developed, all FIFRA S ection 3 and 24c product labels will be amended accordingly.

Similarly, the registrants have ag reed to revise product labels to include language that is sufficiently restrictive to pr eclude residential post-applicat ion exposure to the general public, particularly children. The registrants have indicated that st arlicide 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 Se ction 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: Preliminar y Problem Formulation Starlicide

, September 1, 2011 for a detailed discussion of the ke y 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 th e 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 populat ions 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 additi on, starlicide also posed acute ri sks 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 rate s on all broadcast applications to 0.1 pounds active ingredient per acre; requ iring pre-baiting to ensure ra pid bait acceptance by target species; restricting the use of treated baits to at least 50 f eet from bodies of water; and classifying all starlicide products as restricted use pesticides.13  Since the RED was completed, EPA has conduc ted 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 guideli ne 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 lim ited 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 starli cide is not mutagenic.

Dietary (Food and Drinking Water) :

 The previous starlicide risk assessment design ated registered uses of starlicide as nonfood with the stipulation that uses allowing a pplication to areas where food or feed crops were grown be removed from existing labels a nd that labels be revi sed to include a 365- day prohibition on grazing animals and growi ng crops on lands treated with starlicide baits. Under these conditions, a dietary e xposure 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 restricti ons against placement of treat ed baits within 50 feet of
water bodies.

Residential (Non-occupational):

 At the time of the RED the majority of starlici de products were classifi ed 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 rere gistration, the RED required that the one starlicide product classified for general use be reclassified as rest ricted use, not for purchase or applica tion by homeowners.

 While the RED assessment indicated that th ere was potential e xposure to residents entering treated sites after application, the Agency concluded that post-treatment14 residential exposures would be minimal base d on use restrictions. Thus, a residential post-application exposure assessment was not conducted during the previous risk

assessment.

Aggregate:

 An aggregate risk assessment typically ev aluates the combined risk from dietary exposure (food plus drinking wa ter) 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 qua litatively 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-applica tion 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 potentia lly 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 Informa tion System (EIIS), the ‘Aggregate Incident Reports’ (AIR) database, and the Avian M onitoring 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 i nvolved cowbirds. The Agency acknowledges that these are target species for some starlicide products, a nd if information is available, these incidents
will be discussed in further detail in th e 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 System s. Based on the lack of reported incident15 cases, there does not appear to be a concer n 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) website 5

.

5 http://oaspub.epa.gov/pestlabl/ppls.home16 

### 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: Preliminar y 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 leaching 6 TGAI 12 835.1240 Adsorption / desorption 6 TGAI 12
835.2410 Photodegradation in soil TGAI 12

835.4100 Aerobic soil metabolism 7 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 soil 8 TEP 12

835.6200 Environmental chemistry analytical methods and ILV
for water 9 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

II 10 TEP 12

850.4400 Aquatic plant growth, vascular plants Tier II for Lemna gibba 10 TGAI or

TEP 12

6 Either the soil column l eaching or the adsorption / desorp tion study is expected to be required to satisfy the

mobility data requirement. The adsorption / desorption st udy is preferred, but the so il 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 requi red 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 observ ed 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 species 10 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