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



## Starlicide Final Work Plan Registration Review

March 20123 

### 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 star licide. 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 starlic ide 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 need ed to make a registra tion review decision.

The Agency’s implementation of the registrati on review program requi res review of each registered pesticide every 15 years to determin e whether it continues to meet the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA) standard for registration. Changes in science, public policy, and pestic ide use practices occur over time. The registration review program is intended to make sure that, as the ab ility to assess risk evolves and as policies and practices change, all registered pesticides contin ue to meet that statutory standard. The public phase of registration review begins when the ini tial docket is opened for e ach case. Information on this program is provided on the Agency’s website 1

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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. There are currently no residential uses. Starlicide was first regi stered 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 b een 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 th at may satisfy identified data needs or justify why data are not needed for the registration review of starlicide. Upon recei pt 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 require ments, or timeline, the Agency will amend the

FWP and announce this amendment in the Federal Register.

1 http://www.epa.gov/oppsrrd1/registration_review/4 Summary of Comments and Agency Responses:

During the public comment period on the St arlicide Summary Docu ment, which began on September 30, 2011 and ended on November 29, 2011, the Agency received three public comments. Comments were submitted by the P hysicians 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 requireme nts. In the PWP, EPA also solicited comments on the specific topics of envir onmental justice, water body impairme nt, and trade irritants, but no

comments or information were received on thos e 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 Probl em 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 registra tion review docket (EPA-OPP-2011-0696).

Comments submitted by PM Resources (a subs idiary of Virbac Corporation) in EPA-HQOPP-2011-0696-0008 and comments submitted by the United States Department of Agriculture, Animal and Plant Health In spection Service (APHIS) in EPA-HQ-OPP-2011-

0696-0009.

Note: Due to the substantial similarity in public comments received fr om PM Resources and APHIS, the two registrants of starlicide produc ts, 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 wa iver requests for the 24 anticipated data requirements listed in the Pre liminary Work Plan. Due to the coordination and time needed to develop these documents, PM Resources and APHIS anticipate submit ting information to EPA by February 29, 2012.

APHIS estimated that the cost of the antic ipated 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. Addi tionally, APHIS believes that the oversight maintained over the use of starlicide products (certifie d applicators only, pre-baiting assessment, and site-speci fic tailoring), the limited use pat terns, and minor use / low volume limit starlicide’s potential fo r long-term environmental and human health exposures and do not trigger the need for the new data require ments proposed in the Preliminary Work Plan.

Response: The Agency appreciate s 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 submi ssions support altering the5 registration review data requireme nts, 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 reflecte d by labeled directions for use.

The Agency understands PM Resources’ and APHI S’s perspective on stu dy costs along with the specialized use pattern of starlicide produc ts. However, additional data are needed to adequately assess potential human health and ecological risks fr om starlicide use. Based on

EPA’s review of the current Section 3 and 24c product labe ls, the Agency needs further information regarding the potenti al short and long-term environm ental exposure to non-target organisms as well as occupational and non-occupa tional exposures to wo rkers and the public.

Additional label clarification and restrictions , as well as information presented in the anticipated waiver requests, may he lp to reduce these uncertainties.

Comments submitted by the Physicians Comm ittee for Responsibl e Medicine (PCRM) in EPA-HQ-OPP-2011-0696-0010.

2. Comment: PCRM noted that there is a European st udy 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 us ing data from that study rather than conducting a new study.

Response: The Agency appreciate s 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 detail s about the conduct of the study. Registrants and the public are welcome to submit data for EP A 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 “Quan titative” according to our guidanc e to evaluate acute risks to passerines.

3. Comment: PCRM stated that an acute inhala tion 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 ex isting acute inhalation data, including

derivation of an LC50 based on the available da ta, to the Agency for review. Since EPA does not currently have an acceptable acute i nhalation 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 pr eviously conducted study (if reviewed and found to be acceptable), an adequate open li terature study, or submission of a new study.

4. Comment: PCRM stated that the prenatal devel opmental 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 reproduc tive toxicity study, and this would reduce the number of animals needed to conduct the studies.6 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 ri sk assessment during registration review. If toxicological endpoints or points of departure are revised based on th e 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 regist ration 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 registrati on 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 a nd toxicity databases for starlicide. EPA will require the following studies for use in conducti ng a complete ecological risk assessment, including an endangered species assessment, for the registra tion 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 laborator y validation (ILV) for soil7 835.6200 (footnote 7) – Aquatic field dissipation study 2

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) 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 will be required to qua ntitatively assess risk to aquatic organisms, due to potential offsite runoff a nd 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 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 will not be conducted during registration review because there are currently no registered f ood 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 as sessment would be required.

 A drinking water dietary assessment for starlicide will not be conducted during registration review because there are no tole rances for starlicide, and thus, a human dietary risk assessment is not required. Moreover, given the limited use pattern of

starlicide and label rest rictions that prohibit placing tr eated baits near water bodies, a drinking water assessment is not 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-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.8 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 expos ures 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 re gistration 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 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, and9 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/

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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 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 ar e currently underway, but it is expected to take additional time for label language to be deve loped, submitted to EPA, and approved by the Office of Pesticide Programs’ Re gistration Division. If additi onal information provided by the registrants changes the expected registration review risk asse ssments, data requirements, or timeline, the FWP will be amended and announced in a Federal Register notice.

As noted previously, the Agency will require se veral environmental fate, ecological effects, and human health studies through a da ta call-in, expected to be is sued in late 2012. This new information will be used to conduct complete risk assessments for all starlicide uses.10 

### SUMMARY OF DATA GAPS – STARLICIDE

The table below summarizes all data needs for starlicide in Section I of this document, EFED Registration Review: Preliminary Pr oblem 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 leaching 3 TGAI 12
835.2410 Photodegradation in soil TGAI 12

835.4100 Aerobic soil metabolism 4 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 5 TEP 24

835.6200 Aquatic field dissipation study 6 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 7 TEP 12

3 Either the soil column leaching or th e 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 requi rement. 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 con ducted in lieu of a Tier II study with the understanding

that any adverse effects observed by th e Tier I study would necessitate conduct and submission of a Tier II study as
well.11 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 species 7 TGAI 12

Nonguideline Honeybee acute oral TGAI 12

870.1300 Acute inhalation toxicity - rat TGAI 8 870.3250 90-day dermal toxicity 8 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

8 Based on the registered use patterns, a 28-day dermal t oxicity study would be acceptab le in lieu of the guideline

90-day study.