1 Docket Number: EPA-HQ-OPP-2009-0637 www.regulations.gov



# Deltamethrin Summary Document Registration Review: Initial Docket
March 2010

Case # 74143 T ABLE OF C ONTENTS

Page #

I. Preliminary Work Plan 4

II. Fact Sheet 12

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This Preliminary Work Plan (PWP) and Fact Sheet summarize the Environmental Protection Agency’s current position base d on the following documents:

1 “Environmental Fate and Ecological Risk Asse ssment Problem Formulation in Support of Registration Review for Deltamethrin,” USEPA, March 23, 2010.
2 “Deltamethrin

. Human Health Assessment Scoping Document in Support of Registration Review,” USEPA, February 17, 2010.
3 “Updated Review of Deltamethrin Incident Reports,” USEPA, November 24, 2009.
4 “EFED Section 3 Registration of Deltamethrin for use on Flax and Results from the
Submission of a 6a2 Adverse Effects Daphnid Study,” USEPA, September 27, 2007
5 “Tolerance Petition for Us es of Deltamethrin (PC Code 097805) on Field Corn, Sorghum, Soybeans, Sunflowers, Bulb Ve getables, Cucurbit Vegetables, Leafy Vegetables, Fruiting Vegetables, Carrots, Po tatoes, Radishes, Artichokes, Cauliflower, Broccoli, Cabbage, Mustard Greens, Tree Nu ts, Stone Fruits, and Pome Fruits (DP Barcode D262498) Incremental Ecological Effects Risk Assessment Due to the New Uses,” USEPA, August 6, 2002.
6 “Ecological Effects Branch Review of Deltamethrin,” USEPA, January 17, 1994
7 “Tier I Estimated Drinking Water Concentra tions of Deltamethrin for the Use in the
Human Health Risk Assessment: IR-4 Tolera nce Petition for the Use of Deltamethrin on Flax,” USEPA, April 24, 2007.
8 “ Deltamethrin--Response to Tolerance Peti tion for Use on Flax,” USEPA, August 13,
2009.
9 “Screening Level Use Analysis for Deltamethrin,” USEPA, March 16, 2009.
10 “Appendix A: Food/Feed & Non-Food/Non-F eed Uses Considered in Registration Review Work Planning—Deltamethrin,” April 13, 2009
11 Wolansky, M. J., C. Gennings, and K. M. Crof ton. “Relative Potencies for Acute Effects of Pyrethroids on Motor Function in Rats,” Tox. Sci. 89(1), pp. 271–277 (2006).

Documents 1-10 may be found in the de ltamethrin docket EPA-HQ-OPP-2009-0637 at www.regulations.gov

.4 I. PRELIMINARY WORK PLAN—Deltamethrin

Introduction

The Food Quality Protection Act 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 re view 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 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 www.epa.gov/oppsrrd1/registration_review/

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The Agency is implementing the registration review program, and will review each registered pesticide every 15 years to determin e whether it continues to meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. Where
assessments indicate risks above EPA’s level of concern (LOC), the Agency will consider benefits information and data as required by FI FRA. 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 a dditional risk analyses and data or information
it believes are needed to make a registration review decision. Af ter reviewing and responding to
comments and data received in the docket durin g this initial comment period, the Agency will develop and commit to a final work plan and sche dule for the registration review of deltamethrin.

Deltamethrin is a pyrethroid registered for us e on cotton, sorghum, ar tichokes, pears and a variety of vegetable, fruit, and tree nut crops for the control of a broad spectrum of pests including mites, ants, weevils, a nd beetles. It is also regist ered for use in residential and industrial applications for the control of cockro aches, pests of stored commodities, and other nuisance or destructive insects. A deltamethrin pet collar is registered for the control of fleas and ticks. Deltamethrin was first registered in the U.S. in 1994, and products containing deltamethrin
were first marketed in the United States in 1997.

Deltamethrin is also a metabolite of the pyr ethroid pesticide tralomethrin, so that deltamethrin may occur as a result of applications of tralomethrin. In humans, tralomethrin is metabolized completely and rapidly into delt amethrin. As a result, EPA assumes that tralomethrin and deltamethrin have equivalent toxicity for human health risk assessment purposes. Tralomethrin breaks down more slowly in the environment than in the human body; the Agency may consider the compounds to have equivalent toxicity for mammals only. During registration review, the Agency will consider the appropriate method for addressing combined exposures from deltamethrin applied as a pest icide and deltamethrin originating from applications of tralomethrin.5 The docket for the registration review of tralom ethrin is opening at the same time as the
deltamethrin docket. The tralomethrin docket can be accessed via www.regulations.gov under
Docket ID OPP-2010-0116.

Anticipated Risk Assessment and Data Needs

The Agency expects to require data needed to update and revise the ecological risk assessment for deltamethrin (including an enda ngered species risk as sessment) and the human health risk assessment. As noted above, the Agency will consider the appropriate method for addressing combined exposures from deltamethri n applied as a pesticide and deltamethrin originating from applications of tralomethrin.

Ecological risk

The most recent assessment for deltamethrin was conducted in 2007, prompted by a proposal for a new tolerance for flax. The 2007 assessment references a 2002 assessment, and
the 2002 assessment in turn references a 1994 assessment:

 “EFED Section 3 Registration of Deltamethrin for use on Flax and Results from the
Submission of a 6a2 Adverse Effects Daphnid Study,” USEPA, September 27, 2007.

 “Tolerance Petition for Uses of Deltamethrin (PC Code 097 805) on Field Corn, Sorghum, Soybeans, Sunflowers, Bulb Vegetables, Cucu rbit Vegetables, Leafy Vegetables, Fruiting Vegetables, Carrots, Potatoes, Radishes, Ar tichokes, Cauliflower, Broccoli, Cabbage, Mustard Greens, Tree Nuts, Stone Fruits , and Pome Fruits (DP Barcode D262498) Incremental Ecological Effects Risk Assessm ent Due to the New Uses,” USEPA, August 6, 2002.

 “Ecological Effects Branch Review of Deltamethrin,” USEPA, January 17, 1994.

The Agency has not conducted a risk assessment that supports a complete endangered species determination for deltamethrin. The ecological risk assessment planned during registration review will allow the Agency to determine whether deltamethrin’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with th e U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (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 deltamethrin:

• Guideline # 835.4300 Aerobic Aquatic Metabolism

• Guideline # 835.4400 Anaerobic Aquatic Metabolism

• Guideline #s 835.6100 & 6200 Environmental Chemistry Methods and Independent Laboratory Validations for So il, Water and Sediment

• Guideline # 850.2100 Passerine Acute Avian Oral

• Guideline # 850.1400 Fish Early Life Stage (saltwater)

• Guideline # 850.1500 Fish Life Cycle (saltwater)6 • Guideline # 850.1350 Aquatic Inverteb rate Life-Cycle (saltwater)

• Guideline # 850.1790 Whole sediment, chronic invertebrates freshw ater and marine

• Guideline # 850.4150 & 4250 Vegetative vigor and Seedling emergence, Tier I/ Tier II

• Guideline # 850.4400 Aquatic Vascular Plant Growth- Lemna spp. Tiers I/II

• Guideline # 850.5400 Algal toxicity test

, Tier I/II

Please refer to the document “Environmental Fa te and Ecological Risk Assessment Problem Formulation in Support of Registration Revi ew for Deltamethrin, March 23, 2010 for a more detailed discussion of anticipated eco logical risk assessment data needs.

Human Health Risk

The most recent assessment for deltamethrin was conducted in 2009, prompted by a proposal
for a new tolerance for flax. The assessment is documented in:

 “Tier I Estimated Drinking Water Concentra tions of Deltamethrin for the Use in the
Human Health Risk Assessment: IR-4 Tolera nce Petition for the Use of Deltamethrin on Flax,” USEPA, April 24, 2007.

 “ Deltamethrin--Response to Tolerance Peti tion for Use on Flax,” USEPA, August 13,
2009.

Additional analyses are discussed in:

 “Deltamethrin--Human Health Assessment Scoping Document in Support of Registration Review,” USEPA, February 17, 2010.

This latter document includes an aggregate risk assessment that incorpor ates residential uses not covered by the 2009 assessment, and documents some aggregate risk estimates of concern. The Agency believes that a refined assessment utilizing additional data and new assessment methodologies may reduce some of these risk estima tes relative to conservative, default data and methodologies. For some residential uses with very low MOEs, refinement of the risk assessment is not likely to reduce risk estimates below levels of concern, and the Agency is currently working with affected re gistrants to mitigate the risks.

• The existing residue chemistry database for de ltamethrin is adequate for risk assessment

purposes.

• The Agency is investigating the need fo r additional experimentation, regarding the pharmacokinetics of pyrethroids and the poten tial for increased su sceptibility of young organisms. The Agency will revisit its decision on the need for an FQPA or other database uncertainty/safety factors following receipt of the toxicity data the Agency expects to require, and following a final dete rmination of the potential for increased susceptibility of infants and children to pyret hroid pesticides based on the results of all
available data.

• Aside from the potential outcome of the research described above, the toxicology7 database for deltamethrin is essentially complete, with the exception of the immunotoxicity data. The Agency exp ects to require an immunotoxicity study (Guideline # 870.7800).

• The Agency anticipates conducting a new dietar y risk assessment in registration review to incorporate updated drinking water estimate s, information on dietary consumption, and usage information. In order to better unders tand post-application residential exposure, the Agency expects to require data on the transfer of de ltamethrin residues from pets wearing deltamethrin flea co llars to humans. The Agen cy anticipates developing a refined aggregate assessment for combined exposures from food, drinking water, and residential exposures.

• The Agency anticipates conducting a new occu pational risk assessment in registration review, which would utilize any new and rele vant toxicological endpoints, exposure data, policies, and incident data as appropriate.

• Deltamethrin is an animal and environm ental metabolite of another pyrethroid insecticide, tralomethrin. The docket for th e registration review of tralomethrin is opening at the same time as the deltamethrin docket. In recent assessments, the human toxicology endpoint selected for tralomethrin is derived from the same study as that used in assessing the risks associated with deltame thrin use, and the dietary risk assessment for
deltamethrin accounted for tralomethrin us e. The registration review docket for
tralomethrin can be accessed via www.regulations.gov under Docket ID OPP- 2010-
0116.

• In 1997, tolerances for tralomethrin and delta methrin were reassessed in response to a general policy change in which time limitations for tolerances were deleted. For this FQPA reassessment, exposures associated with the use of both tralomethrin and
deltamethrin were combined. The basis for this approach was that tralomethrin is rapidly metabolized by animals to deltamethrin (as a result of debromination) and the toxicology profiles of deltamethrin and tralomethr in are virtually identical.

• The Agency is currently working to devel op an approach for addressing human health risks from combined exposures to deltameth rin applied as a pesticide and deltamethrin residues originating from app lications of tralomethrin.

• Deltamethrin is a member of the pyrethroid clas s of insecticides. This class also includes permethrin, cypermethrin, cyfluthrin, tau- fluvalinate, bifenthri n, fenpropathrin, and lambda-cyhalothrin, among others. EPA deve loped a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids (Draft Science Policy Paper: Common Mechanism Grouping for the Pyrethrins and Synthetic Pyrethroid Pestic ides, May 19, 2009, available in the docket at http://www.regulations.gov/search/R egs/home.html#documentDetail?R=09000064809a6
2df ). The FIFRA Scientific Advisory Panel (SAP) supported the draft science policy8 (Minutes from the SAP meeting on the Evalua tion of the Common Mechanism of Action of the Pyrethroid Pesticides, Septembe r 9, 2009, available in the docket at 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 recomme ndations of the SAP. Pesticides with a common mechanism of toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going by EPA’s Office of Research and Developm ent (ORD) to make improvements to the Stochastic Human Exposure and Dose Simula tion (SHEDS) probabilistic 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 re viewed by the FIFRA SAP in July, 2010. For information regarding EPA’s efforts to ev aluate the risk fr om pyrethroids, see http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.html

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• During registration review, the tolerance expression for deltamethrin in 40 CFR §
180.435 will be reviewed to ensure that it appropriately covers the metabolites and degradates of deltamethrin and that it specifi es the residues to be measured for each commodity. Any proposed revisions would be to the chemical description rather than the
individual tolerance levels.

The Agency anticipates needi ng the following data in order to conduct a complete human
health risk assessment for deltamethrin:

• Guideline # 870.7800 Immunotoxicity

• Special Study, Pet Collar Residue Transfer

Please refer to the document “Deltamethrin

. Human Health Assessment Scoping Document in Support of Registration Review,” February 17, 2010 for a more detailed discussion of human
health risk estimates and an ticipated human health risk assessment data needs.

Other Data Needs

• Guideline # 830.7050 UV/Visible Light Absorp tion – this study is a new data requirement under 40 CFR part 158 (Produc t Chemistry Data Requirements) for registration of a pes ticide (food and non-food uses). The Agency anticipates requiring this study to obtain basic information about the compound’s identity/composition and the wavelengths at which the compound may be susceptible to photoc hemical 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 screening assays to identify the potential of a9 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 quantitative relationship betw een 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 pesticid e active ingredients and 9 inert ingredients.
This list of chemicals was selected based on th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.
This list should not be construed as a lis t of known or likely endocrine disruptors.

Deltamethrin is not among the group of 58 pesticide 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 which EPA has already opened a Registration Review docket for a pestic ide 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 sc reening battery, please visit the website: http://www.epa.gov/endo/

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Timeline

The projected timeline for the deltamethrin registration review appears in the table below.

Projected Deltamethrin 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 2013 – April - June Open Public Comment Period for Preliminary Risk Assessments 2014 – Oct. – Dec.
Close Public Comment Period 2015 – Jan. - March Registration Review Decision Open Public Comment Period for Proposed Registration Review
Decision 2015 – April - June

Close Public Comment Period 2015 – July – Sept. Final Registration Review Deci sion and Begin Post-Decision Follow-up 2016

Total (years)* 6 * An assessment of the potential cumulative risk from the pyrethroid class of insecticides may impact this time10 estimate.

Guidance for Commenters; Solicitation of Information

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consider a ll comments, and any additional information that is provided in a timely manner, prior to issuing a final work plan for the deltamethrin registration
review 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 disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality

Deltamethrin is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=88
5 . However, the pyrethroids as a group have been identified as a cause for impairment for three water bodies in Central Valley, CA: Del Puerto Creek, Ingram Creek Site (confluence with Hospital Creek to Hwy 33 crossing) and a sec ond Ingram Creek Site (confluence with San Joaquin River to confluence with Hospital Creek). Nonetheless, no Total Maximum Daily Loads (TMDL) have been developed for deltame thrin, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&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 exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmen tal justice, the fair treatmen t and meaningful involvement of all people, regardless of race, color, nati onal origin, or income, in the development, implementation, and enforcement of environmenta l laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of th eir location, cultural practi ces, or other factors, may have atypical, unusually high exposure to de ltamethrin compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure, compared to the general population.11 Additional Information

Stakeholders are asked to provide additional information that will assist the Agency in refining its assessments for deltamethri n, such as the following information:

1. Deltamethrin human, domestic animal, or eco logical incidents not al ready reported to the Agency.

2. Information on or confirmation of the following use parameters: Sites of application Formulation type Application methods and equipment Maximum application rates expr essed as mass ai per unit area Typical application rates Factors affecting application rate, e.g ., weather, disease pres sure, fresh/processed commodity Application intervals, factors a ffecting frequency of application Maximum number of applications pe r year (or season, as appropriate).

3. Use or potential use distribution ( e.g ., geographical distribution of us es, areas of greatest use).

4. General use history.

5. Median and 90th percentile reported use rates from usag e data – national/state/county.

6. Application timing (date of first applicati on and typical applicati on intervals) by use – national, state, and county.

7. Sub-county use site data.

8. Usage data for non-agricultural uses ( e.g ., residential uses, paints and paint additives, building materials, restaurants, buses, railcars, trucks, ti re piles, mausoleums, warehouses, and food handling establishments).

9. Directly acquired county-level usage data (not derived from state level data). Maximum reported use rate from usage data – county Median and 90th percentile numbe r of applications – county Total pounds per year – county Year the pesticide was last us ed in the county/sub-county area (if no longer used), and/or Years in which the pesticide was appl ied in the county/sub-county area.

10. State, local, or other ge ographic use restrictions.

11. Any adverse effects in honey bees associat ed with the use of deltamethrin products.

12. Co-formulation or tank-mixing of deltamethri n and other pesticides (especially other12 pyrethroids)—is deltamethr in typically applied w ith other pesticides?

13. Mode of action for flea collars, that is, how deltamethrin spreads over the body of the pet or
how fleas otherwise come into contact with deltamethrin from the flea collar.

14. Confirmation of the use of de ltamethrin in plastic foam pane ls; use patterns and potential exposures to deltamethrin used in these panels, e.g., where such panels are used, who installs them (professionals or homeowners), how many could an individual typically install in a working day/in a year, what is the potential for exposure for resi dents or occupants of buildings where they are installed (are they open to the living space, or behind wall paneling, for example).

15. Use patterns and potential exposures to delt amethrin for sites on which the Agency lacks such information, including: food storage facilities, dairies, f ood processing facilities, eating establishments, food markets, grocery stores, bathrooms, garbage cans, commercial animal kennels, ships/boats/automob iles/taxis/limousines/recreational vehicles, tires, bedding/mattresses, carpets, drainage systems, hospitals, morgues/mortuaries, caskets, and
cadavers.

Next Steps

After the 60-day comment period closes, th e Agency will review and respond to any comments that have been submitted in a timely manner, and then issue a Final Work Plan for this pesticide. The Agency expects to issue a Fi nal Work Plan for deltamethrin in August 2010.13 II. FACT SHEET: Deltamethr in Registration Review

Background Information for Deltamethrin

 Registration review case number: 7414

 Pesticide Chemical (PC) Code: 097805

 Chemical Abstracts Service (CAS) number: 529 18-63-5

 Other names: (S-cyano(3-phenoxyphenyl)m ethyl (1 R,3R)-3-(2,2-dibromoethenyl)-2,2- dimethylcyclopropanecarboxylate, (S- α -cyano-3-phenoxybenzyl (1 R)

- cis-3-(2,2- dibromovinyl)-2,2-dimethylcyclopropanecarboxylate ;

 The deltamethrin active ingredient is co mposed of three isomers, with the cis- isomer making up about 99% of the total.

 Chemical Class: Deltamethrin is a T ype II pyrethroid. Pyrethroids are grouped by
structure and mode of action into several different types. Cypermethrin, cyfluthrin, cyphenothrin, esfenvalerate, fluva linate, and tralomethrin ar e also Type II pyrethroids.

 Deltamethrin was first registered in the U.S. in 1994.

 Four registrants hold a total of eight manufacturing-use deltam ethrin registrations. Over
30 formulators hold a total of more than 140 end-use registrations.

 There are no FIFRA Special Local Need 24(c) products registered with the Agency.

Contact information

 Pesticide Re-evaluation Division: Jill Bloom; bloom.jill@epa.gov

 Registration Division: Olga Odiott; odiott.olga@epa.gov

Use & Usage Information

The Agency has conducted a Screening Level Us age Analysis (SLUA) for deltamethrin and developed a listing of use parameters for the use sites of deltamethrin. The SLUA and “Appendix A” (as the listing of use parameters is known) are available in the deltamethrin
docket.

 Deltamethrin is a pyrethroid acaricide/insecticid e registered to control a variety of pests, including mites, ants, weev ils, and beetles on many site s, including cotton, sorghum, artichokes, pears, and a variet y of vegetable, fruit, and tr ee nut crops. It is also registered for use both indoors and outdoors in a number of residen tial and institutional settings for control of bedbugs, cockroaches, si lverfish, mosquitoes, wasps, other flying and crawling insects, fleas, and ticks. Non-crop, non-residential uses include restaurants, buses, railcars, trucks, tire piles, mausoleums, warehouses, and food handling establishments.

 About 6,000 lbs. and 1,000 lbs. of deltamethrin ai /year are used on cotton and sorghum, respectively. For each of the remaining agricu ltural use sites, less than 500 lbs. in used annually. Between 15 and 20% of the artichoke crop is treated with deltamethrin. For the other agricultural sites, 5% or less of the crop is treated. The Agency does not have14 estimates for non-agricultural usage.

 End-use products may be formulated as r eady-to-use liquid sprays and pressurized liquids, paint additives and pa int, granulars, dusts, wettabl e powders, and flowable and
emulsifiable concentrates.

 Rates of application vary by use site. Agricultural applicatio ns are generally in the range of 0.005 to 0.130 lb ai/A/application. The flea and tick collars for dogs contain 4% active ingredient by weight and the user is directed to apply a new collar every six months.

 Application methods include drench, crack a nd crevice, spot treatment, and broadcast spraying. Application equipment includes aero sol can, spreader, aerial, chemigation, and a variety of handheld equipment (e.g., sprinkler can, backpack, low pressure handwand). Paint formulated with deltamethrin may be applied by brushing, rolling, dipping, or airless sprayer.

 Number of applications is fre quently not stated on labels.

Recent and Related Actions

 A recent petition for establishing tolerances fo r deltamethrin on flax has been withdrawn. The Agency sought public comment on an application for a proposed new use of
deltamethrin on flax for one month be ginning on October 26, 2009 (FRL–8794–2). No comments were received. The application was subsequently withdrawn.

 Deltamethrin is a mammalian and environmental metabolite of another pyrethroid insecticide, tralomethrin. The docket for th e registration review of tralomethrin is opening at the same time as the deltamethrin docket. The registration review docket for
tralomethrin can be accessed via www.regulations.gov under Docket ID OPP- 2010-
0116.

Ecological Risk Assessment Status

Refer to the supporting documents, including “Environmental Fate and Ecological Risk Assessment Problem Formulation in Support of Re gistration Review for Deltamethrin,” USEPA, March 23, 2010, for a discussion of the most cu rrent ecological risk and endangered species

assessments.

Deltamethrin is “practically nontoxic” on an acute basis to the avian sp ecies that have been tested; no chronic effects were observed in bobw hite quail and mallard duck. Deltamethrin is “highly toxic” to honey bees on an acute basis. Deltamethrin is “very highly toxic” to the
freshwater and marine/estuarine fish and invertebrate species that have been tested, and impairment of growth and reduced reproductive success have been observed in chronic studies on the freshwater species. In the field, deltame thrin tends to bind to so il particles and organic matter, and it is not expected to leach into groundwater. Deltamethrin may reach aquatic resources through spray drift or erosion. It is m oderately to highly persis tent in the terrestrial15 environment and has the potential to persist in aquatic environments, particularly in the sediment. In laboratory studies, deltamethrin exhibited a potential for bioaccumulation in fish. The incremental risk associated with the propos ed use on flax was based on an earlier assessment of pome fruit (apple, pear, etc. ) in which the Agency determined there were chronic risks of
concern for fish and aquatic invertebrates, specia lly those living in or near the benthos.

Human Health Risk Assessment Status

Please refer to the supporting do cuments, including “Deltamethrin

. Human Health Assessment Scoping Document in Support of Regi stration Review,” USEPA, February 17, 2010,
for a discussion of the most recent human health risk assessment.

At the current time, EPA has selected the toxi cological endpoint for the human health risk
assessment of deltamethrin based on an acute ex posure study documented in the open literature: Wolansky, M. J., C. Gennings, and K. M. Croft on. “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 motor 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 extrapolation and 10x for in traspecies variation) was applied. The Wolansky study utilized adult ra ts, but other studies fr om the open literature
are indicative of increased sus ceptibility in young animals base d on toxicokinetic differences between young and adult animals. Because of this evidence of increased susceptibility, the 10x FQPA Safety Factor was retained for populati on subgroups comprised of infants and children. Therefore, the overall uncertainty factor is 1000x for all deltamethr in exposure scenarios involving these subgroups, and 100x for all other populations.

Cumulative assessment

Deltamethrin is a member of the pyrethroid clas s of insecticides. Other pyrethroids include permethrin, cypermethrin, cyflut hrin, tau-fluvalinate, bifenthr in, fenpropathrin, and lambdacyhalothrin. EPA has developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring py rethrins and synthetic pyrethroids, which was supported by the FIFRA Scientific Advisory Pane l (SAP). Upon finalization of this science policy, the pyrethroids will be subject to a cumulative risk assessment under the FQPA.

Incident Reports

 Examination of the OPP Incident Data System (IDS) and the Centers for Disease Control
and Prevention/National Institute for Occ upational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupa tional Risk (SENSOR) database revealed a moderately large numbers of case reports in humans associated with the use of
deltamethrin. Most of these incidents were of low severity, and no patterns or trends were discerned. The Agency will continue to monitor the incident information and if a16 concern is triggered, additional analysis will be included in the registration review risk

assessment.

 The Ecological Incident Information System (E IIS, version 2.1) maintained by the Office of Pesticide Programs, and the Avian Monitoring Information System (AIMS), maintained by the American Bird Conservancy, show one reported ecological incident associated with the
use of deltamethrin. The report for this incident describe s a fish kill of approximately 350 bullhead fish ( Ameirurus sp.). This incident resulted fr om a golf course application of three chemicals: imidacloprid, thiophanate-met hyl and deltamethrin. The incident report identified deltamethrin as the probable cause of the fish kill.

Tolerances and International Harmonization

 Tolerances for deltamethrin are located at 40 CFR § 180.435; they can be accessed electronically in Volume 40 of the eCFR by searching for “deltamethrin” at http://ecfr.gpoaccess.go v/cgi/t/text/textidx?sid=f7b808a2bc0a1bee945ff 568ee85707e&c=ecfr&page=simple

 There are many Codex MRLs for deltamethrin. The MRLs can be found by searching for
“deltamethrin” at the International Portal on Food Safety, animal & Plant Health at http://www.ipfsaph.org/En/default.jsp

.

Data Call-In Status

 Currently, there are no outstanding, previous ly required data for deltamethrin.

Labels

Images of the labels of registered deltamethr in products can be obtained from the Pesticide Product Label System (PPLS) website at http://oaspub.epa.gov/ pestlabl/ppls.home

.