Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of tralomethr in. This FWP includes the expected registration review timeline. This work plan also addresses public comments concerning the Preliminary Work Plan in the Summary Document , which was posted in the tral omethrin registration review docket (Docket Number EPA-HQ-2010-0116), and any other comments c oncerning the initial docket postings. The tralomethrin Summary Document provided information on what EPA knows about the pesticide and what additional risk analysis data or information the Agency
believes are needed to make a registration review decision.

The Agency is implementing the registra tion review program and will review 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 at http://www.epa.gov/oppsrrd1/registration_review/

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Tralomethrin is a broad-spectrum Type II syst emic pyrethroid ester insecticide used in a variety of residential and comme rcial settings, and on a small number of agricultural crops including broccoli, cauliflower, co tton, lettuce, peanuts, and sunflo wers. Since tralomethrin was first registered in 1985, it was not subject to a Reregistration E ligibility Decision (RED). In 1997, EPA reassessed tolerances of tr alomethrin as required by FQPA. (62 Fed. Reg. 62,993, November 26, 1997).

This document finalizes the work plan for th e tralomethrin registra tion review process.

Actions since Publication of PWP

In August 2010 the Agency received a volunt ary cancellation request from the technical registrant, Bayer Crop Sciences, to cancel all re gistered tralomethrin product registrations. A Federal Register Notice (FRN) will be published announcing EPA’s receipt of Bayer’s request to voluntarily cancel all tralomethr in product registrations. This notice will initiate a 30-day comment period. EPA intends to grant this request at the close of the comment period for this announcement unless the Agency receives substan tive comments within the comment period that would merit its further review of the requests, or unless the registrant withdraws their request within this period. This action will cancel the sole technical product registration for tralomethrin. Therefore, the Agency anticipates that no further risk assessments or additional data will be needed in support of this regist ration review if these pe nding product cancellations become final and effective. If the cancellations become final and effective the Agency will issue a proposed final decision for tralomethrin. However, if the pending can celations are withdrawn or otherwise not implemented, the risk assessmen t and data needs outlined in this Final Work Plan will be required in support of this registration review.

2Comments Received on Preliminary Work Plan

On March 31, 2010 EPA opened a 60-day public comment period for the registration review of tralomethrin. The comment peri od ended on June 1, 2010. The Preliminary Work
Plan document can be located in the tralomet hrin registration revi ew docket (EPA-HQ-OPP2010-0117) at www.regulations.gov

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In the PWP, EPA solicited comments on three specific topics: environmental justice, water body impairment and trade irritants. No comments or information were received during the public comment period concerning these issues . EPA also received no comments during the 60-day public comment period on the initial docket for tralomethrin.

Risk Assessment and Data Needs

Should the pending registration terminations become final and e ffective, the human health and ecological risk assessments and data n eeds as described in this FWP will no longer be needed. However, if the pending terminations of all tralomethrin pr oduct registrations are withdrawn or otherwise not implemented, a comp rehensive ecological risk assessment, including an endangered species risk assessment, is anticipated as being needed for all uses of tralomethrin. Dietary, residential, occupationa l, and aggregate human exposur e risk assessments are also anticipated as being needed

Tralomethrin breaks down in the environm ent 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 assumes that tralomethrin and deltamethrin have equivalent toxicity for human health ri sk assessment purposes. However, tralomethrin breaks down more slowly in the environment th an in the human body so equivalent toxicity cannot be assumed for organisms other than mammal s. Therefore, tralomethrin and deltamethrin residues resulting from tralomethrin use will be c onsidered independently in the ecological risk assessment. Deltamethrin use is being assessed individually in registration review (case #7414; docket ID OPP-2010-0116). During registration review, the Agency will consider the appropriate method for addressing combined exposures from deltamethrin applied as a pesticide and deltamethrin originating from applications of tralomethrin. However, should the pending registration terminations become final and e ffective, a combined exposure assessment from deltamethrin (applied as a pesticide) and delt amethrin originating from application of tralometherin is not anticipated as being needed because all tralomethrin uses will be cancelled.

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 registration review will allow the Agency
to examine whether tralomethrin’s use has “ no effect” or “may affect” federally listed threatened or endangered species (listed specie s) or their designated critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its

3designated critical habitat, the Agency w ill consult with the U.S. Fish and Wildlife Service (FWS) and/or National Marine Fisher ies Service (NMFS) (the Services), as appropriate.

• The Agency anticipates requiring the followi ng data in order to conduct a complete ecological risk assessment, including an enda ngered species assessment for tralomethrin:

Tralomethrin :

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

o GDLN 835.2120 – Hydrolysis

o GDLN 835.2240 – Photodegradation in Water

o GDLN 835.2410 – Photodegradation on Soil

o GDLN 835.4100 – Aerobic Soil Metabolism

o GDLN 835.4300 – Aerobic Aquatic Metabolism

o GDLN 835.4400 – Anaerobic Aquatic Metabolism

o GDLN 835.6100 (footnote 7) – Environmen tal Chemistry Methods – soil

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

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

o GDLN 850.1025 – Acute Toxicity Estuarin e and Marine Organisms (oyster) (typical end-use product)

o GDLN 850.1035 – Acute Toxicity Estuarin e and Marine Organisms (mysid) (typical end-use product)

o GDLN 850.1075 – Acute Toxicity Estuarine a nd Marine Organisms (fish) (typical end-use product)

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

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

o GDLN 850.2100 –Avian Oral Toxicity (passerine species)

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

o GDLNs 850.4400 & 850.5400 – Aquatic Plant Grow th (algal and aquatic vascular plant toxicity) (Tier I and Tier II) 3

o GDLN 850.1790 – Whole Sediment: Chronic Invertebrates (estuarine/marine) ( Leptocheirus plumulosus)

o GDLN 850.1790 – Whole Sediment: Chroni c Invertebrates (freshwater) ( Hyalella

azteca and Chironomus dilutus )

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 Spec ies, and Drinking water Assessments for Tralomethrin ( March 23, 2010)

. 2 A Tier II is only required if a tested terrestrial species exhibits a 25% or greater detr imental effect in the Tier I study. When Tier II testing is required, the test species sh ould be the species that showed detrimental effects in the Tier I testing.

3 A Tier II is only required if the tested aquatic species e xhibits a 50% or greater detrim ental effect in the Tier I study. When Tier II testing is required, the test species sh ould be the species that showed detrimental effects in the Tier I testing.

4Deltamethrin :

o GDLN 835.4300 – Aerobic Aquatic Metabolism

o GDLN 835.4400 – Anaerobic Aquatic Metabolism

o GDLN 835.6100 (footnote 7) – Environmen tal Chemistry Methods – soil

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

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

o GDLN 850.1350 – Aquatic Invertebrate Li fe Cycle (estuarine/marine)

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

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

o GDLN 850.2100 –Avian Oral Toxicity (passerine species)

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

o GDLNs 850.4400 & 850.5400 – Aquatic Plant Grow th (algal and aquatic vascular
plant toxicity) (Tier I and Tier II) 5

o GDLN 850.1790 – Whole Sediment: Chroni c Invertebrates (freshwater) ( Hyalella

azteca and Chironomus dilutus )

o GDLN 850.1790 – Whole Sediment: Chronic Invertebrates (estuarine/marine) ( Leptocheirus plumulosus)

• The following data would be used to in form removal percentages by waste water treatment, which is an input to the Exposure and Fate Asse ssment Screening Tool’s (EFAST) down-the-drain module. The Office of Pesticide Program s will continue to confer with the Office of Water with the goa l of refining our down-the-drain assessment for registration review. These studies should be conducted on deltamethrin.

o Publicly Owned Treatment Work s (POTW) Effluent Monitoring

o Publicly Owned Treatment Works (POTW) Treatability Study

• For a more detailed discussion of the anticipated ecological ri sk assessment needs refer to
the Registration Review – Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species , and Drinking water Assessments for
Tralomethrin (March 23, 2010), which is located in the docket.

Human Health Risk

• Tralomethrin is rapidly and completely metabolized in the human body to another pesticide active ingredient deltamethrin. Th erefore, human health risk assessments for
tralomethrin and deltamethrin are based on a combined tralomethrin/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

4 A Tier II is only required if a tested terrestrial species exhibits a 25% or greater detr imental effect in the Tier I study. When Tier II testing is required, the test species sh ould be the species that showed detrimental effects in the Tier I testing.

5assessment 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 existi ng pyrethroid 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 py rethroids. EPA has recently determined that, as an alternative to the generation and submissi on of a new DNT study, pyr ethroid registrants may instead choose to cite the six previously submitted DNT studies for pyrethroid pesticides. The Agency is also investiga ting the need for additional experimentation, specific to the mode of action and pharmac okinetic characteristics of pyrethroids, to evaluate the potential for increased sus ceptibility of young organisms. Additional
information can be found on EPA’s website: http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html

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• 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 detoxify deltamethrin relative to adults. The Agency ma y revise its FQPA f actor following receipt of required toxicity data and following a final determination of the potential for increased susceptibility of infants and children to pyret hroid 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 us e in registration review. This assessment will incorporate updated drinking water estimates, consumption information, usage information, and monitoring data.

• The Agency has not previously conducted residential handler or post-application exposure assessments for tralomethrin. Th erefore, the Agency anticipates conducting residential handler and post -application exposure risk as sessments during registration
review for tralomethrin. These assessments will take into account, as appropriate, any changes in toxicological endpoi nts, new exposure data, revisi ons to the current policies and procedures for conducting exposure asse ssments, and any new poising incident data
on tralomethrin.

• The Agency anticipates conducting an aggr egate assessment for tralomethrin in registration review to incor porate the planned residential exposure assessment and an updated dietary risk assessment. During registration review, the Agency will consider the appropriate method for addressing combined exposures from deltamethrin applied as a pesticide and deltamethrin originating fr om applications of tralomethrin.

• The Agency has not previously conducted an occupational handler or an occupational post-application exposure assessment for tralomet hrin. Therefore, the Agency anticipates

6conducting a comprehensive occupational risk assessment in registration review for
tralomethrin. These assessments will take into account, as appropriate, any changes in toxicological endpoints, new exposure data, revisions to the current policies and procedures for conducting exposure assessmen ts, and any new poising incident data on
tralomethrin.

• Tralomethrin belongs to the pyrethroid class of insecticides. This class also includes permethrin, cypermethrin, cyfluthrin, tau- fluvalinate, bifenthri n, fenpropathrin, and lambdacyhalothrin, among others. EPA has developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids, which was supported by the FIFRA Scientific Advisory Panel (SAP). Upon finalization of this science policy, the pyrethroids will be subject to a cumulative risk assessment under the FQPA.

• The Agency anticipates requiring the followi ng 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)

• 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 hea lth risk assessment 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 Requirements) for registration of a pesticide (food and non-food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s id entity/composition and the wavelengths at which the compound may be suscepti ble to photochemical degradation.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach to making the 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

7establish a quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders / data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was sele cted based on the potenti al for human exposure through pathways such as food and drinking wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Tralomethrin is not among the group of 58 pes ticide active ingredients on the initial list
to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuin g future EDSP orders / data call-ins for all registration review cases, in cluding those for which EPA ha s 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, please visit EPA’s website: http://www.epa.gov/endo/

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Timeline

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

Registration Review for Tralomethrin– Projected Registration Review Timeline

Activities Estimated Date Opening Docket Open Docket and Public Comment Period 2010 – March
Close Public Comment 2010 – May Case Development
Final Work Plan 2010 – September

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 and Begin Post-Decision Follow-up 2018 Total (years) 8
*This time estimate will shorten should the pending re gistration terminations become final and effective.

8Next Steps

If the pending termination of all tralomethrin product registrations is withdrawn or otherwise not implemented, the Agency anticipa tes requiring several ecological effects and human health studies through a Data Call-In (DCI) Notice, expected to be issued in 2011. This
new information will be used to conduct the risk assessments outlined in this FWP for all
tralomethrin uses.

However, if the pending registration termin ations become final and effective and a cancellation order is issued, the Agency anticipate s that it will not be n ecessary to conduct new risk assessments for tralomethrin and, theref ore would anticipate issuing a proposed final decision pursuant to 40 CFR Part 155.53(c)(2) and 40 CFR Part 155.58.

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