Docket Number EPA-HQ-OPP-2010-0116 www.regulations.gov

Tralomethrin Summary Document Registration Review: Initial Docket

March 20103 TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 14

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. Registration Review – Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking water Assessments for Tralomethrin (March 23, 2010)

2. Tralomethrin. Human Health Assessment Sc oping Document in Support of Registration Review (February 24, 2010) 3. PRD Appendix A: Food/Feed & Non-Food/N on-Feed Uses Consider ed in Registration Review Work Planning – Tral omethrin (121501 (December 22, 2008 4. Screening Level Estimates of Agricultural Us es of Tralomethrin (121501) (April 7, 2009) 5. Updated Review of Tralomethr in Incident Reports, June 30, 2009

All supporting documents for the registration review of Tralomethrin are located in docket EPA-HQOPP-2010-0116 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Tralomethrin

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registrati on review program. All pesticides distributed or sold in the United St ates (U.S.) generally must be registered by the Environmental Protection Agency (EPA), based on sc ientific 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 reevaluate s pesticides to make sure that as change occurs, products in the marketplace can be used safely. Info rmation on this program is provided at: http://www.epa.gov/oppsrr d1/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 whatit knows about the pesticide and what additional risk analyses and data or information it believes ar e needed to make a regist ration 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 tralomethrin.

Tralomethrin is a broad-spectrum Type II syst emic pyrethroid ester insecticide used in a variety of residential and commerc ial settings, and on a small number of agricultural crops including broccoli, cauliflower, cotton, le ttuce, peanuts, and sunflowers. Since tralomethrin was first registered in 1985, it was not subject to a Reregist ration Eligibility Decision (RED). In 1997, EPA

reassessed tolerances of tralom ethrin as required by FQPA. (62 Fed. Reg. 62,993, November 26, 1997).

Tralomethrin breaks down in the envir onment and the human body into another active pesticide ingredient, deltamethri n. In humans, tralomethrin is metabolized completely and immediately into deltamethrin. As a result, EPA a ssumes that tralomethrin and deltamethrin have equivalent toxicity for human health risk assess ment purposes. However, tralomethrin breaks down more slowly in the environment than in the hum an body so equivalent toxicity cannot be assumed for organisms other than mammals. Therefore, tralomethrin and deltamethrin residues resulting from tralomethrin use will be considered indepe ndently in the ecological risk assessment.

Deltamethrin use is being assesse d individually in registration review (case #7414; docket ID OPP-2010-0116). During registration review, the Ag ency will consider the appropriate method for5 addressing combined exposures from deltamethri n applied as a pesticide and deltamethrin originating from applications of tralomethrin.

In 2009, in response to a proposed new use on fla x, EPA conducted a diet ary risk assessment that evaluated dietary exposure from the combined usage of deltamethri n and tralomethrin. This risk assessment showed that the combined exposures from the existing uses of tralomethrin and deltamethrin result in acute dietary risk estimates of concern for infants an d children. Accordingly, the new deltamethrin use was not granted. EPA is currently refining this dietary risk assessment with updated usage and monitoring data, and expects that these refinements will reduce dietary risk

estimates below levels of concern.

Anticipated Risk Assessment and Data Needs

The Agency anticipates conducting a comprehens ive ecological risk a ssessment, including an endangered species risk assessment, for all uses of tralomethrin. The Agency also anticipates conducting dietary, residential, o ccupational, and aggregate human exposure risk assessments.

Ecological Risk:

• The Agency has not conducted an ecological ri sk assessment that s upports an endangered species determination for tralomethrin.

• The ecological risk assessment planned during re gistration review will allow the Agency to

examine whether tralomethrin’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designa ted critical habitats. When an assessment concludes that a pesticide’s use “m ay affect” a listed species or its designated critical habitat, the Agency will consult w ith the U.S. Fish and Wildlife Service (FWS)

and/or National Marine Fish eries Service (NMFS) (the Services), as appropriate.

• The Agency anticipates needing the following da ta in order to conduct a complete ecological risk assessment, including an endanger ed species assessment for tralomethrin:

Tralomethrin

• GDLN 835.1230 or 825.1240 – Leaching and adsorption/desorption 1

• GDLN 835.2120 – Hydrolysis

• GDLN 835.2240 – Photodegradation in Water

• GDLN 835.2410 – Photodegradation on Soil

• GDLN 835.4100 – Aerobic Soil Metabolism

• GDLN 835.4300 – Aerobic Aquatic Metabolism

1 If the registrant can clarify defici encies observed in a previously subm itted study (MRID 44 814506), a leaching adsorption/desorption study will not be required. See Registration Review – Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Sp ecies, and Drinking water As sessments for Tralomethrin ( March 23, 2010)

.6 • GDLN 835.4400 – Anaerobic Aquatic Metabolism

• GDLN 835.6100 (footnote 7) – Environm ental Chemistry Methods – soil

• GDLN 835.6200 (footnote 7) – Environmen tal Chemistry Methods – water

• GDLN 835.6200 (footnote 7) – Environmenta l Chemistry Methods – sediment

• GDLN 850.1025 – Acute Toxicity Estuarine and Marine Organisms (oyster) (typical enduse product)

• GDLN 850.1035 – Acute Toxicity Estuarine and Marine Organisms (mysid) (typical enduse product)

• GDLN 850.1075 – Acute Toxicity Estuarine and Marine Organisms (fish) (typical enduse product)

• GDLN 850.1400 – Fish Early-Life Stage (estuarine/marine)

• GDLN 850.1500 – Fish Life-Cycle (estuarine/marine)

• GDLN 850.2100 –Avian Oral Toxicity (passerine species)

• GDLNs 850.4100 & 850.4150 – Seedling Emergence & Vegetative Vigor (Tier 1 & Tier 2) 2

• GDLNs 850.4400 & 850.5400 – Aquatic Plant Growth (algal and aquatic vascular plant toxicity) (Tier I and Tier II) 3

• Special Study – Whole Sediment: Chroni c Invertebrates (estuarine/marine) ( Leptocheirus plumulosus)

• Special Study – Whole Sediment: Ch ronic Invertebrates (freshwater) ( Hyalella azteca

and Chironomus dilutus )

Deltamethrin

• GDLN 835.4300 – Aerobic Aquatic Metabolism

• GDLN 835.4400 – Anaerobic Aquatic Metabolism

• GDLN 835.6100 (footnote 7) – Environm ental Chemistry Methods – soil

• GDLN 835.6200 (footnote 7) – Environmen tal Chemistry Methods – water

• GDLN 835.6200 (footnote 7) – Environmenta l Chemistry Methods – sediment

• GDLN 850.1350 – Aquatic Invertebrate Life Cycle (estuarine/marine)

• GDLN 850.1400 – Fish Early-Life Stage (estuarine/marine)

• GDLN 850.1500 – Fish Life-Cycle (estuarine/marine)

• GDLN 850.2100 –Avian Oral Toxicity (passerine species)

• GDLNs 850.4100 & 850.4150 – Seedling Emergence & Vegetative Vigor (Tier 1 & Tier 2) 4

2 A Tier II is only required if a tested terrestrial species exhib its a 25% or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrim ental effects in the Tier I testing.

3 A Tier II is only required if the tested aquatic species exhibits a 50% or greater detrimen tal effect in the Tier I study. When Tier II testing is required, the test species should be th e species that showed detrimental effects in the tier I testing.

4 A Tier II is only required if a tested terrestrial species exhib its a 25% or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrim ental effects in the Tier I testing.7 • GDLNs 850.4400 & 850.5400 – Aquatic Plant Growth (algal and aquatic vascular plant toxicity) (Tier I and Tier II) 5

• Special Study – Whole Sediment: Ch ronic Invertebrates (freshwater) ( Hyalella azteca

and Chironomus dilutus )

• Special Study – Whole Sediment: Chroni c Invertebrates (estuarine/marine) ( Leptocheirus plumulosus)

• Please refer to Registration Review – Preliminary Probl em Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking water Assessments for

Tralomethrin (March 23, 2010), for a more detailed discussion of the anticipated ecological

risk assessment needs.

Human Health Risk:

• Tralomethrin is rapidly and completely meta bolized in the human body to another pesticide active ingredient deltamethrin. Therefore, human health risk assessments for tralomethrin

and deltamethrin are based on a combined tr alomethrin/deltamethrin toxicity database.

• The most recent risk assessment that evalua ted exposure to tralomethrin use was a 2009 dietary assessment completed for the proposed new use of de ltamethrin on flax. This assessment evaluated the dietary exposure from the combined usage of tralomethrin and

deltamethrin. Tralomethrin and deltamethrin were also combined when tolerances were reassessed pursuant to FQPA in 1997.

• Based on the Agency’s review of existing pyret hroid data, EPA has come to the conclusion that the DNT is not a particularly sensitive study for comparing the sensitivity of young and adult animals to pyrethroids. As an alternat ive to the generation and submission of a new DNT study, the tralomethrin registrants may inst ead choose to cite the previously submitted DNT study for deltamethrin. The Agency is also investigating th e need for additional experimentation, specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evaluate the pot ential for increased susceptibility of young organisms. A meeting of FIFRA Scientific Advisory Pane l (SAP) is planned for July 2010. EPA is currently soliciting proposals fo r study design and protocols. For more information on the pyrethroid DNT requirement, see http://www.epa.gov/oppsrrd1/r eevaluation/pyrethroidspyrethrins.html

.

• In 2009, EPA retained a 10X FQPA safety factor for deltamethrin based on recent literature

studies that showed children ha ve a diminished capacity to det oxify deltamethrin relative to adults. The Agency may revise its FQPA factor following receipt of required toxicity data and following a final determination of the potentia l for increased susceptibility of infants and

5 A Tier II is only required if the tested aquatic species exhibits a 50% or greater detrimen tal effect in the Tier I study. When Tier II testing is required, the test species should be th e species that showed detrimental effects in the tier I testing.8 children to pyrethroid pesticides based on the results of all available data.

• The existing residue chemistry database for tr alomethrin is adequate for risk assessment

purposes.

• The Agency anticipates conducting a new diet ary risk assessment evaluating combined residues from tralomethrin and deltamethrin use in registration review. This assessment will incorporate updated drinking water estimates, consumption information, usage information, and monitoring data.

• When EPA reassessed tralomethrin tolerances in 1997, it combined residential exposure of

tralomethrin and deltamethrin for risk assessm ent purposes. The basis for this approach was that tralomethrin is rapidly metabolized by animals to deltamethrin (as a result of debromination), the toxicology profiles of de ltamethrin and tralomethrin are virtually identical. At the time, the“flea infestation control” scenario was thought to represent plausible but worst-case residential exposure from deltamethrin and tralomethrin use. However, in registration review, the Agency anticipates conducti ng a residential risk assessment specific to tralomethrin use patterns.

• The Agency anticipates conducting an aggregate assessment for tralomethrin in registration review to incorporate the planne d residential exposure assessme nt and an updated dietary risk assessment. During registration review, the Ag ency will consider the appropriate method for addressing combined exposures from deltamethri n applied as a pesticide and deltamethrin originating from applications of tralomethrin.

• The Agency has not previously conducted an occupational handler oran occupational postapplication exposure assessment for tralomethr in. Therefore, the Agency anticipates conducting a comprehensive occupational risk assessment in registration review, which incorporates updated toxicologi cal endpoints, exposure data, re vised policies, and incident data as appropriate.

• Tralomethrin belongs to the pyrethroid class of insecticides. This class also includes permethrin, cypermethrin, cyflut hrin, tau-fluvalinate, bifenthr in, fenpropathrin, and lambdacyhalothrin, among others. EPA developed a dr aft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethri ns and synthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and pyrethroids, draft, May 19,

2009 http://www.regulations.gov/search/Regs/hom e.html#documentDet ail?R=09000064809a62df )

. This document was supported by the FIFRA Sc ientific Advisory Panel (SAP) and is

available in the docket. See http://www.regulations.gov/search/Reg s/home.html#documentDetail?R=0900006480a1f8d7

. EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comm ents. Pesticides with a comm on mechanism of toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going by EPA’s9 Office of Research and Developm ent (ORD) to make improvements to the Stochastic Human Exposure and Dose Simulation (SHEDS) probabilis tic exposure model, which are important

for the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokinetic models for several pyrethroids . The status of both of these research modeling efforts will be reviewed by the FIFRA SAP in July, 2010. For information regarding EPA’s efforts to evaluate the risk to pyrethroids. See http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html.

• The Agency anticipates requiring the following data in order to conduct a complete human

health risk assessment for tralomethrin:

o GDLN 870.7800 – Immunotoxicity Study

o GDLN 870.6300 – Developmenta l Neurotoxicity (DNT) 6

• Please refer to Tralomethrin. Human Health Assessm ent Scoping Document in Support of Registration Review (February 24, 2010), available in the docket, for a detailed discussion of the anticipated human health risk asse ssment and data needs for tralomethrin.

Other Data Needs:

• GLDN 830.7050 UV/Visible Li ght Absorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Require ments) for registration of a pesticide (food and non-food uses). The Agency anticipates requ iring this study to obt ain basic information about the compound’s identity/composition and th e wavelengths at which the compound may be susceptible to photochemical degradation.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain su bstances (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 effect s 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 a ny, 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 es tablish a quantitative relationship between the dose and the E, A, or T effect.

6 The registrant may choose to cite to the previously submitted DNT study for deltamethrin.10 Between October 2009 and February 2010, EPA issued te st orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingr edients and 9 inert ingredients. This list of chemicals was selected based on the potential fo r human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios. This list should

not be construed as a list of know n or likely endocrine disruptors.

Tralomethrin is not among the group of 58 pesticid e active ingredients on th e initial list to be

screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates i ssuing future EDSP orders/data call-ins for all Registration Review cases, including those for whic h EPA has already opened a Registration Review docket for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/

.11 Timeline:

The Agency has created the following estimated timeline for the completion of the tralomethrin registration review.

Registration Review for Tr alomethrin– Projected Regi stration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – March Close Public Comment 2010 – May Case Development Final Work Plan 2010 – August Issue DCI 2011 – April - June Data Submission 2015 – April - June Open Public Comment Period for Preliminary Risk Assessments 2016 – Oct. – Dec.

Close Public Comment Period 2017 – Jan. - March Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2017 – April - June

Close Public Comment Period 2017 – July – Sept. Final Registration Review Decision a nd Begin Post-Decision Follow-up 2018 Total (years) 8

1. If the registrants choose to cite the previously submitted DNT study for deltamethrin, as explained above, rather than conducting a DNT study with tralomethrin, this tim e estimate will likely be shortened by approximately
two years. 2. An assessment of the potential cumulative risk from the pyrethroid class of insecticides may impact this time

estimate.

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration re view 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 tralomethrin 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 re sulting 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.12 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 their location, cultural practices, or ot her factors, may have atypical, unusually high exposure to tralomethrin compared to the general population. Please comment if you are aware of any sub-populations th at may have atypical, unusually high exposure, compared to the general population.

Water Quality:

Tralomethrin is not identified as a cause of impairment for any wa ter bodies listed as impaired under section 303(d) of the Clean Water Ac t, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=885

. However, the pyrethroids as a group have been iden tified as a cause for impairment for three water bodies in Central Valley, CA: Del Puerto Creek, I ngram Creek Site (confluence with Hospital Creek to Hwy 33 crossing) and second Ingram Creek Site (confluence with San Joaquin River to confluence with Hospital Creek). Nonetheless, no Total Maximum Daily Loads (TMDL) have been developed for tralomethrin, base d on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_na tion.tmdl_pollutant_deta il?p_pollutant_group_id=88 5&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possi ble, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: In clusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registration R eview Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/registra tion_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Additional Information:

Stakeholders are also specifically asked to provide information and da ta that will assist the Agency in refining risk assessments, including any species -specific ecological effects determinations. The Agency is interested in receiving 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, a pplication intervals, and maxi mum number of applications per season and per year13 f. geographic limitations on use

2. Use or potential use distribution ( e.g . geographical distributio n of relevant uses).

3. Use history.

4. Median and 90 th percentile reported use rates (lb/A, lb 1K sq.ft) from usage data – national, state and county.

5. Application timing (date of firs t application and application intervals) by use – national, state, and county.

6. Usage/use information for non-agricultural uses.

7. Directly acquired county-level usage data (not derived from state level data).

a. maximum reported use rate (lb/ cc) from usage data – county

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

8. Typical application interval (days).

9. State or local use restrictions.

10. Ecological incidents specific to tralomethrin (non-target plant damage and avian, fish, reptilian, amphibian, mammalian mortalities, and bee or beneficial inse ct mortalities) not already reported to the Agency.

11. Monitoring data.

12. Any adverse effects in honey bees or other be neficial insects associated with the use of tralomethrin products.

Next Steps:

After the 60-day comment period closes, the Ag ency will consider and respond to any comments received in a timely manner and then expects to issu e a Final Work Plan in August of 2010 for

tralomethrin.14 II. FACT SHEET

Background Information:

• Tralomethrin registration review case number: 7400

• Tralomethrin PC Code: 121501; CAS # 66841-25-6

• Tralomethrin was first registered in the United States in 1985.

• Technical registrant: Bayer CropScience LP, Bayer Environmental Science, & Valent Biosciences Corporation

• There are 44 FIFRA Section 3 active product re gistrations, including th ree manufacturing use registrations.

• Pesticide Re-evaluation Divisi on Contact: Joy Schnackenbeck ( schnackenbeck.joy@epa.gov )

• Registration Division Co ntact: Richard Gepkin ( gebkin.richard@epa.gov ).

Use and Usage Information: (For additional details, please refer to Food/Feed & Non-Food/NonFeed Uses Considered in Registration Review Work Pl anning – Tralomethrin (121501) (December 22, 2008) in the tralomethrin docket).

• Tralomethrin is a pyrethroid ins ecticide registered for a variety of agricultural and residential uses including broccoli, cotton, lettuce, soybeans, sunflowers, household dwellings, ornamentals, lawns and turf, pet dwellings, garbage cans, paths, patios, wood protection, industrial outdoor areas, paved areas, agricultural farm prem ises, vehicles, ships, boats, caskets, warehouse premises, eating establishm ents, egg packing plants, food processing plants, food stores, greenhouses , hospital/medical instituti ons, meat processing plants.

• Tralomethrin is used to control a variety of insects including aphids , worms, ants, gnats, moths, beetles, grasshoppers, mites, midges, sp iders, ticks, yellow j ackets, maggots, thrips, caterpillars, flies, fleas, and ot her pests in domestic, public hea lth, agricultural, and industrial

situations.

• Tralomethrin is formulated as a solid bait, em ulsifiable concentrate, granular formulation, liquid, pressurized gas, pressurized liquid, solid, and wettable powder.

• Tralomethrin can be applied by aircraft, a nd a variety of ground sprayers, including hand pressure sprayer, low pressure sprayer, power sprayer, hand-held sprayer, and aerosol can.

• The four primary agricultural uses of tralomethr in are cotton, soybeans, lettuce and broccoli. A majority of this agricultural use is for lettuce and broccoli (approximately 61% and 37% respectively).

Recent Actions:

• There have been no recent actions.15 Ecological Risk Assessment Status

The following summarizes ecological effects data from registrant-submitted studies and data available from open literature. The Agency has not previously conducted a comprehensive ecological risk assessment that integrates envi ronmental exposure and ecological effects for all

tralomethrin uses. Please refer to Registration Review – Prelimi nary Problem Formulation for Ecological Risk and Environmen tal Fate, Endangered Species, and Drinking water Assessments for Tralomethrin (March 23, 2010) located in the docket, for a detailed discussion of what is currently known about the environmental fate and ecological effects associated with

tralomethrin.

• Tralomethrin transforms to its structurally similar degradate de ltamethrin in the environment.

• Tralomethrin and deltamethrin are classified as very highly toxic on an acute basis to

estuarine/marine and freshwater fish, aquatic-phase amphibians, and aquatic invertebrates.

Tralomethrin and deltamethrin are also toxic on a chronic basis to freshwater fish and

freshwater invertebrates. Tral omethrin is highly toxic to estu arine/marine invertebrates on a

chronic basis. A chronic estuarine/marine invertebrate study is not available for deltamethrin. In addition, chroni c estuarine/marine fish studies are not available for either

tralomethrin or deltamethrin.

• Tralomethrin and deltamethrin ar e practically nontoxic on an acute basis to birds, terrestrialphase amphibians and reptiles. Chronic tral omethrin exposure to birds can result in reproductive effects (reduced eggshell thickness and reduction of live three-week embryos). Similar reproductive effects from deltameth rin exposure have not been observed.

• Tralomethrin and deltamethrin are both highly toxic to terrestr ial invertebrates, including beneficial insects such as honeybees.

• No data are available to evalua te toxicity of tralomethrin and deltamethrin to terrestrial and aquatic plants.

Human Health Risk Assessment Status

The following are key findings of the human he alth risk assessments conducted to support tralomethrin registered uses. Please refer to Tralomethrin. Human Health Assessment Scoping Document in Support of Registration Review (February 24, 2010) located in the docket for a detailed

discussion of the human hea lth risk assessment status.16 Hazard Characterization:

In humans, tralomethrin is metabolized instanta neously to its structurally-similar degradate, deltamethrin. Therefore, tralomethrin endpoints for dietary, occupational a nd residential exposure

scenarios are identical to those for de ltamethrin and are based upon a combined tralomethrin/deltamethrin toxicity database. In addition, when EPA reassessed tralomethrin tolerances pursuant to FQPA, the Agency combined deltamethrin and tralomethrin exposure for risk

assessment purposes.

Tralomethrin has moderate acute toxicity through the oral and inhalation r outes of exposure and low or mild acute toxicity through the dermal route of e xposure. Tralomethrin is moderately irritating to the eye, non-irritating to the skin and is not a skin sensitizer.

The carcinogenic potential of tralomethrin has no t been classified. However, deltamethrin is classified as “not likely to be carcinogenic to humans” based on carcinogenicity studies in rats and

mice.

When EPA reassessed tralomethrin tolerances pursuant to FQPA in 2007 it concluded that an additional FQPA safety factor was not needed to protect the safety of in fants and children from tralomethrin and deltamethrin exposure. At th e time, there was no eviden ce of developmental, reproductive, or post-natal sensitivity. However, in 2009, EPA retained a 10X FQPA safety factor for deltamethrin for all exposure scenarios and dura tions for infants and children. This was based on an open literature study that s howed children have a diminished capacity to detoxify deltamethrin relative to adults. (Wolansky, M. J., C. Gennings , and K. M. Crofton. “Relative Potencies for Acute Effects of Pyrethroids on Motor Function in Rats,” Tox. Sci. 89(1), pp. 271–277 (2006)).

In the Wolansky study, decreased mo tor activity was observed in ra ts receiving oral doses of deltamethrin. The NOAEL was calculated at 1 mg /kg/day and is applicable for all exposure

durations because deltamethrin is rapidly eliminated from the body, precluding bioaccumulation, and no additional toxicity would be expected with increased dosing duration. A traditional uncertainty factor of 100x (10x for interspecies ex trapolation and 10x for intr aspecies variation) was applied. The Wolansky study utilized adult rats, but other studies from the open literature are indicative of increased susceptibility in young an imals based on toxicokinetic differences between young and adult animals. Because of this evidence of increased susceptibility, the 10x FQPA Safety Factor was retained for population subgroups compri sed of infants and children. Therefore, the overall uncertainty factor is 1000x for all de ltamethrin exposure s cenarios involving these subgroups, and 100x for all other populations.

Dietary Risk:

A screening level dietary risk as sessment was performed for a proposed new use of deltamethrin on flax in 2009 and evaluated dietary exposure resulting from all regist ered uses of deltamethrin and tralomethrin. Drinking water expos ure estimates were only calculate d for deltamethrin use and did17 not incorporate tralomethrin use. Dietary expos ure risk estimates for children 12 years old and younger exceeded the Agency’s level of concern (infants 110% aPAD, children 1-2 130% aPAD, children 3-5 140% aPAD, children 6-12 110% aPAD). The new flax use was never granted. The Agency is currently working on a refined dietary exposure assessment evaluating registered uses of tralomethrin and deltamethrin, which incor porates updated usage and monitoring data.

Residential and Recreational Risk:

In the 1997 tolerance reassessment, the “flea infestation control” sc enario was chosen to represent plausible but worst-case residentia l exposure from deltamethrin and tr alomethrin use. Risks did not

exceed levels of concern.

A ggregate Risk:

In the 1997 tolerance reassessment, aggregate exposure to tralomet hrin and deltamethrin did not

exceed levels of concern.

Occupational Risk:

Occupational handler and post-application expos ure assessments have not been previously

conducted.

Cumulative assessment:

Tralomethrin is a member of the pyrethroid clas s of insecticides. This class also includes permethrin, cypermethrin, cyfluthr in, fluvalinate, bifenthrin, fenpr opathrin, and lambda-cyhalothrin, among others. EPA developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and syntheti c pyrethroids (Proposed common mechanism grouping for the pyrethrin s and pyrethroids, draft, May 19, 2009; http://www.regulations.gov/search/R egs/home.html#documentDetail?R=09000064809a62df ). This document was supported by the FIFRA Scientific A dvisory Panel (SAP) a nd EPA will finalize the policy document on the pyrethroid common mechanism of toxicity taking into account the SAP comments. Pesticides with a common mechanism of toxicity are subject to cumulative risk assessment under the FQPA. Research is on-goi ng by EPA’s Office of Research and Development (ORD) to make improvements to the SHEDS probab ilistic exposure model which are important for

the cumulative risk assessment. EPA ORD is also developing physiologically-based pharmacokinetic models for several pyrethroids. The status of both of these research modeling efforts will be reviewed by the FIFRA SAP in Ju ly, 2010. For information regarding EPA’s efforts to evaluate the risk to pyrethroids, http://www.epa.gov/pesticides/cumulative/ .18 Incidents

• In August 2009, a preliminary review of the Ec ological Incident Information System (EIIS)
and the Avian Monitoring Information System (AIMS) Database identified one incident for

tralomethrin and one incident for deltamethrin. Tralomethrin was classified as a probable
cause for an incident in 1994 involving phytot oxic effects to bushes near a residential
application site. The incident a ssociated with deltamethrin was a fish kill of approximately
350 bullhead fish ( Ameirurus sp.). This incident resulted fr om a golf course application of
three chemicals: imidacloprid, thiophanate-methyl and deltamethrin. The incident identified
deltamethrin as the probable cause.

• On June 30, 2009, an updated review of tralomethr in human incident reports was prepared by consulting the OPP Incident Data System (ID S). In the United States, from 2002 to the present, 90 incidents were reported for tralomethr in. Symptoms appear to be generic and it is uncertain whether they are related to exposure. Additionally, there is no clear pattern of toxicity or consistency of expos ure scenarios across incidents.

Tolerances and International Harmonization

• Tolerances are established under 40 CFR 180.422 for residues of tralomethrin that result from agricultural uses as well as use in food and feed handling estab lishments. Tolerances are established in terms of parent tralomethrin and its major metabolites, cis -deltamethrin and

trans -deltamethrin. There are no Canada or Codex maximum residue limits (MRL) for

tralomethrin. Mexico MRLs are ha rmonized with U.S. tolerances.

Data Call-In Status

• There have been no issued data call -ins associated with tralomethrin.

Labels

• Active Section 3 labels for tralomethrin can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.