Docket Number EPA-HQ-OPP-2010-0684 www.regulations.gov



## Cyfluthrins Summary Document Registration Review: Initial Docket September, 2010

13 TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 9

II. Fact Sheet 13

III. Summary of Data Gaps 19

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

1. EFED Registration Review Problem Formulation for Cyfluthrin and Beta -cyfluthrin, July 29,

2010.

2. Cyfluthrin and Beta -cyfluthrin Human Health Assessment Scoping Document in Support of Registration Review, July 1, 2010.

3. Cyfluthrin and Beta -cyfluthrin Screening Level Usag e Analysis (SLUA), September 28,

2009.

4. Usage/Use Report Package in Support of Registration Revi ew for Cyfluthrin (128831), January 26, 2010.

5. Cyfluthrins: Review of Human Incidents, May 20, 2010

All supporting documents for the regist ration review of cyfluthrin and beta -cyfluthrin are located in docket EPA-HQ-OPP-2010-0684 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN – Cyfluthrin and Beta -cyfluthrin

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 or the Agency ), based on scientific data showing that they

will not cause unreasonable risks 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 an d 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 prac tices will occur over time. Through the registration review program, the Agency periodi cally reevaluates pesticides to ma ke sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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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 cyfluthrin and beta -cyfluthrin.

Cyfluthrin and beta -cyfluthrin are pyrethroid insecticides . They are both mixtures of eight isomers of the same compound. Cyfluthrin is compos ed of comparable percentages of eight isomers,

whereas beta -cyfluthrin is an enrichment of the four most efficacious isomer s. Cyfluthrin and beta

cyfluthrin products are registered for use on agri cultural sites, residential indoor/outdoor areas, turf/ornamentals, pets/pet houses, poultry processing plant premises , recreational/golf areas, tobacco, and for use as an outdoor wood prot ection treatment. The first cyfl uthrin registration was approved in 1987, while the first beta -cyfluthrin registration was approved in 1995. As a result, Reregistration Eligibility Decisions (REDs) have not been conducted for these compounds.

Anticipated Risk Assessment and Data Needs

The Agency intends to require data needed to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, and to update and revise the human health risk assessment for all uses of cyfluthrin and beta -cyfluthrin. Below is a summary of the issues relevant to the registration revi ew of cyfluthrin and beta -cyfluthrin and the data the Agency anticipates requiring.5 Ecological Risk:

 The most recent ecological risk assessments on cyfluthrin and beta -cyfluthrin were conducted in 2007, 2006, 2004, and 2001 as a result of several new agricultural uses being added to the product labels.

 The Agency has not conducted an ecological risk assessment that supports a complete endangered species determination for cyfluthrin or beta -cyfluthrin. The ecological risk assessment planned during registration review will allow the Agency to determine whether cyfluthrin and beta -cyfluthrin’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 spec ies 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 endangered species assessment for cyfluthrin and beta

cyfluthrin.

The following anticipated studies sh ould be conducted on cyfluthrin:

Environmental fate data gaps

 GDLN 835.1230– Leaching and Adsorption/Desorption (TGAI)

 GDLN 835.4100 – Aerobic Soil Metabolism (TGAI, 2 Soils)

 GDLN 835.4200 – Anaerobic Soil Metabolism (TGAI)

 GDLN 835.6100 – Environmental Chemistry Method and Independent Laboratory Validation for soil (Footnote 7)

 GDLN 835.6200 – Environmental Chemistry Method and Independe nt Laboratory Validation for Water and Sediment (Footnote 7)

Ecological toxicity data gaps

 GDLN 850.2100 – Avian Oral Toxicity (passerine species) (TGAI)

 GDLN 850.2300 – Avian Reproductive Study

 GDLN 850.1025 – Oyster Acute Toxicity (saltw ater, cyfluthrin TEP only)

 GDLN 850.1035 – Mysid Acute Toxicity (saltw ater, cyfluthrin TEP only)

 GDLNs 850.4100 & 850.4150 – Seedling Emergence & Vegetative Vigor (Tier II)

 GDLNs 850.4400 – Aquatic Vasular Plant Growth – Lemna spp . Tier II

 Non-GDLN – Aquatic Inverteb rate Acute Toxicity ( Hyalella azteca )

 GDLNs 850.1790 – Whole sediment: chronic invertebrates freshwater and marine

The following anticipated studi es should be conducted on beta -cyfluthrin:6 Environmental fate data gaps

 GDLN 835.4100 – Aerobic Soil Metabolism (TGAI, 4 Soils)

 GDLN 835.4300 – Aerobic Aquatic Metabolism (TGAI)

 GDLN 835.4400 – Anaerobic Aquatic Metabolism (TGAI)

 GDLN 835.6100 – Environmental Chemistry Method and Independent Laboratory Validation for soil (Footnote 7)

 GDLN 835.6200 – Environmental Chemistry Method and Independe nt Laboratory Validation for Water and Sediment (Footnote 7)

Ecological toxicity data gaps

 GDLN 850.1350 – Invertebrate Life Cycle, mysid

 GDLNs 850.4100 & 850.4150 – Seedling Emergence & Vegetative Vigor (Tier II)

 GDLNs 850.4400 – Aquatic Vasular Plant Growth – Lemna spp . Tier II

The following data would be used to inform remova l percentages by waste water treatment, which is an input to the Exposure and Fate Assessment Scr eening Tool’s (E-FAST) down-the-drain module. The Office of Pesticide Programs will continue to confer with the Office of Water with the goal of refining our down-the-drain assessm ent for registration review. These studies can be conducted on either cyfluthrin or beta -cyfluthrin. The Agency is recomme nding that these studies be conducted on cyfluthrin.

o Leachability from Treated Wood

o POTW Effluent Monitoring

o POTW Treatability Study

Please refer to the “ EFED Registration Review Problem Formulation for Cyfluthrin and Betacyfluthrin (July 29, 2010),” for a more detailed discussion of the anticipa ted ecological risk

assessment and data needs.

Human Health Risk:

 The most recent human health risk assessmen t was conducted in 2007 in association with new uses on grasses, alfalfa, and sugar beets. The mammalian toxicity is very similar for cyfluthrin and beta -cyfluthrin, and the combined toxico logy database for cyfluthrin and beta

cyfluthrin is considered to be comple te except for an immunotoxicity study.

 Subsequent to the last risk assessment, the Agency identified age-dependent pharmacokinetic factors associated with all pyrethroid insecticid es that might lead to uncertainty regarding effects in children. The Agency anticipates re -evaluating the points of departure (POD) and uncertainty factors used for human health risk assessment during registration review.

 The dietary exposure database is adequate to support the existing registrati ons and tolerances. No new residue chemistry data are expected to be needed. A new drinking water assessment7 may be conducted during registra tion review. Further, a revise d dietary risk assessment may be conducted to include updated percent crop treated estimates, updated monitoring data, changes in toxicological endpoints, and revi sed estimated drinking water concentrations.

 As a result of the revisions to the Agency’s Residential Standard Operating Procedures (SOPs), the parameters and al gorithms for dermal, inhalati on, and hand-to-mouth exposure calculations may change. These changes coul d result in significantly different exposure

estimates for indoor and outdoor uses. Ther efore, during registration review, a new residential exposure assessment is anticipated.

 The potential changes mentioned above (toxicol ogical endpoints, dietary exposure estimates, residential exposure estimates) have led to a determination that an updated aggregate risk assessment may be needed.

 A revised occupational handler and postapplication assessments may need to be conducted based on updated doses and endpoints for derm al and inhalation risk assessments.

 During registration review, the to lerance expressions should be re vised so that they address both coverage and measurement. Please see the human health scoping document for more

details.

 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. EPA has recently determined that, as an alternative to the generation and submission of a new DNT study, pyr ethroid registrants may instead choose to cite the six previously submitted DNT studies fo r pyrethroid pesticides. The Agency is also investigating the need for additional experime ntation, specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evaluate the potential for increased susceptibility of young organisms. Additional information can be found on EPA’s website: http://www.epa.gov/oppsrrd1/reevalua tion/pyrethroids-pyrethrins.htm l

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 The Agency will make a decision regarding changes to any database uncertainty/safety factors for the cyfluthrins following receipt of the remaining required toxicity data, and following a final determination of the potential for increased susceptibility of infants and children to pyrethroid pesticides based on the results of all available data.

 Cyfluthrins are members of the pyrethr oid class of insect icides. EPA has developed a draft science policy document on the proposed comm on mechanism of toxicity for naturallyoccurring pyrethrins and synthe tic pyrethroids, which was su pported by the FIFRA Scientific Advisory Panel (SAP). Upon fi nalization of this science pol icy, the pyrethroids will be subject to a cumulative risk assessment under the FQPA.8  The Agency anticipates requiring the following data in order to conduct a complete human health risk assessment for cyfluthrin and beta -cyfluthrin. The Agency recommends conducting this study with cyfluthrin:

o GDLN 870.7800 – Immunotoxicity Study

 Please refer to the “ Cyfluthrin and Beta-Cyfluthrin Human Hea lth Assessment Scoping Document in Support of Registration Review (July 1, 2010),” available in the docke t, for a detailed discussion of the anticipated human health risk assessme nt and data needs for cyfluthrin and beta -cyfluthrin.

Other Anticipated Data Needs:

 OPPTS GLN 830.7050 UV/Visibl e Light Absorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Re quirements) for registration of a pesticide (food and non-food uses). The Agency antici pates requiring this study to obtain basic information about the compound’s identity/com position and the 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, and or t hyroid (E, A, or T) hormonal system s. 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 any, 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.

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.

Cyfluthrins are among the group of 58 pesticide active ingredients on the initia l list to be screened

under the EDSP. For information on the status of the orders issued under the EDSP for each chemical, please visit our website at http://www.epa.gov/endo/ and click on the "Status of EDSP Orders/DCIs" in the Highlights Box. Additiona l information on the EDSP, including the policies9 and procedures, the list of 67 chemi cals, the test guidelines and the Ti er 1 screening battery, can also

be found at this website.

Other data needs

Agricultural Health Study Cyfluthrins are among several agricultural chemi cals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a co llaboration of the National Institute of Environmental Health Sciences (NIEHS), the Nati onal Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and H ealth (NIOSH). Designed as a large, long-term epidemiological study, the AHS collects and analyzes data on the health and work practices of nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease developed. The study focuse s particularly on farmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall he alth outcomes for people who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they ca n show some statistical associations. More

information on the AHS can be found at: http://aghea lth.nci.nih.gov

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Timeline

The Agency has created the following estimated ti meline for the completion of the cyfluthrin and

beta -cyfluthrin regi stration review.

Registration Review for Cyfluthrin and Beta -cyfluthrin – Projected Registration Review
Timeline

Activities Estimated Date Opening the docket Open Docket and Public Co mment Period 2010 – September

Close Public Comment 2010 – November Case Development

Final Work Plan 2011 – February

Issue DCI 2011 – October –

December

Data Submission 2013 – October –

December Open Public Comment Period for Draft Risk Assessments 2015 – April -June

Close Public Comment Period 2015 –JulySeptember Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – October –

December

Close Public Comment Period 2016- Jan. – Mar.10 Registration Review Decision and Begin Post-Decision Follow-up 2016 Total (years) 1 6 1. 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 revi ew work plan and rationales. 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 cyfluthrin and beta -cyfluthrin

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 f acilitating irritant resolu tion. Growers and other stakeholders are asked to comment on any trade i rritant issues resulti ng from lack of Maximum Residue Limits (MRLs) or dispar ities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possibl e regarding the natu re of the concern.

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 cyfluthrin and beta -cyfluthrin 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.

Water Quality

Cyfluthrin and beta -cyfluthrin are not id entified as a cause of impairme nt 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=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, firs t Ingram 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 Load (TMDL) cr iteria have been devel oped for cyfluthrin or

beta -cyfluthrin, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_na tion.tm dl_pollutant_deta il?p_pollutant_group_id=8811 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 these pesticides. To the extent po ssible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Incl usion 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.

Other 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 year

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 cyfluthrin s (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, including existing or ongoi ng Publically Owned Treatment Works (POTWs) effluent monitoring data for the pyrethroids be submitted to the Agency.12 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 th en expects to issue a Final Work Plan in February of 2011 for cyfluthrin and beta -cyfluthrin.13 II. FACT SHEET

Background Information

 Cyfluthrin and beta -cyfluthrin share the same regi stration review case number: 7405.

 Cyfluthrin PC Code: 128831; beta -cyfluthrin PC code: 118831. Both share CAS # 68359-

37-5.

 Cyfluthrin was first re gistered in 1987, and beta -cyfluthrin was first registered in the United States in 1995. As a result, no Reregistration Eligibility Decisions (R EDs) were conducted for these compounds.

 Technical registrant: Bayer Crop Science LP.

 As of September, 2010, for cyfluthrin, th ere are 92 Section 3 registrations; for beta

cyfluthrin, there are 29 Section 3 registrations and 4 special lo cal need (SLN) registrations.

 Pesticide Re-evaluation Division Co ntact: Yan Donovan (Donovan.yan@epa.gov).

 Registration Division Contact: Olga Odiott (odiott.olga@epa.gov).

Use and Usage Information

(For additional details, please refer to “Usage/Use Report Pack age in Support of Registration Review for Cyfluthrin (128831), Janua ry 26, 2010” and “Cyfluthrin and beta -cyfluthrin Screening Level Usage Analysis (SLUA), Septem ber 28, 2009” in the cyfluthrin and beta -cyfluthrin docket.

 Cyfluthrin and beta -cyfluthrin are a Type II pyrethroid inse cticide registered for a variety of agricultural, non-agricultura l and residential uses.

 For cyfluthrin, the majority of the usage is on agricultural crops su ch as cotton (60,000 lbs ai), corn (30,000 lbs ai), alfalfa and potato (10,000 lbs ai) in the year 2009.

 For beta -cyfluthrin, California DPR usage data indi cates that the majority of usage is in residential settings, such as structural pest control (11,346 - 6,153 lbs ai), landscape maintenance (1,846-398 lbs ai), from 2006-2008, respec tively. Overall, th e trend seems to be decreased over the three years.

Recent and Pending Actions

 There are no pending actions for cyfluthrin or beta -cyfluthrin.

Ecological Risk Assessment Status

The following are key findings from the most rece nt ecological risk assessments regarding the environmental fate, ecological eff ects and risks of cyfluthrin and beta -cyfluthrin.

Please refer to “EFED Registration Review Problem Formulation for Cyfluthrin and Betacyfluthrin,” July 29, 2010, located in the docke t, for a detailed discussion.

Ecological Risks:14  The most recent ecological risk assessments on cyfluthrin and beta -cyfluthrin were conducted in 2007, 2006, 2004, and 2001. These assessm ents indicated risk concerns for freshwater and estuarine/marine organisms. In addition, there were risk concerns for organisms living in the sediment.

Fate Discussions:

 The majority of the environmental fate stud ies for these chemical s were conducted with cyfluthrin, which comprises all eight isomer s. The environmental fate properties of cyfluthrin and beta -cyfluthrin are expected to be similar to each other.

 Based on the environmental fate properties, cyfluthrin and beta -cyfluthrin are hydrophobic and range from hardly mobile to immobile in four soils. The ch emical will bind strongly to the soil surfaces. The primary routes of dissipation are aqueous and soil photolysis, and hydrolysis in alkaline media. Metabolism app ears to be a moderate route of dissipation for these chemicals. The terrestrial field dissipa tion data confirm the pattern observed in the laboratory studies indicating that the chemical follows mixed r outes of dissipation in the field. Laboratory studies showed that cyfluthr in is moderately persistent and, therefore, available for runoff through erosion as well as spray drift.

Ecological effects:

 For terrestrial species, cyfluthrin and beta -cyfluthrin are practica lly nontoxic to birds, moderately toxic to mammals, and highly toxic to terrestrial invertebrate s on an acute basis.

Chronic effects were seen in ra ts at levels as low as 150 ppm and at 250 ppm for birds. No terrestrial plant data have b een submitted to the Agency.

 For aquatic species, numerous aquatic studies have been submitted to the Agency, some of
which were conducted with beta -cyfluthrin. Both are classified as very highly toxic to aquatic organisms based on data for aquatic ve rtebrates and invertebrates. An acceptable toxicity study with green alg ae suggests that cyfluthrin ha s low toxicity to nonvascular aquatic plants. No vascular aquatic plant data has been submitted to the Agency.

Human Health Risk Assessment Status

The following are key findings from the human health risk assessments conduc ted for cyfluthrin and beta

cyfluthrin registered uses . Please refer to the “ Cyfluthrin and Beta-c yfluthrin Human He alth Assessment Scoping Document in Support of Registration Review,” July 1, 2010 , located in the docket for a detailed

discussion of the human hea lth risk assessment status.

Hazard Characterization:15  The toxicity profile was sufficient for characte rization of potential carcinogenic, mutagenic, developmental, and reproductive effects in the mo st recent risk assessm ents. Cyfluthrin and

beta -cyfluthrin are cla ssified as “not likely to be carcinogenic to humans.”

 The acute oral toxicity of both cyfluthrin and beta -cyfluthrin ranges from Toxicity Category I to III, depending on the administration vehicle. Inhalation toxicity cat egories also varied by vehicle from Category II to III. Toxicity was low (Category IV) vi a the dermal route. Cyfluthrin and beta -cyfluthrin are slight eye (Cate gory III) and dermal (Category IV) irritants, but neither is a dermal sensitizer.

 In the most recent risk assessment, neurot oxic endpoints were chosen for all exposure scenarios, with the exception of the inhalati on exposure which route-sp ecific studies were used. The point of departure (POD) for the sh ort-term inhalation exposure was chosen from the 28-day rat inhalation study and is base d on decreased body weight. The POD for intermediate- and long-term i nhalation exposure is based on decreased body weight and body weight gain observed in the 90- day inhalation study in rats. A dermal study is available, but was not used for endpoint selection because deve lopmental effects were not evaluated in that study.

Dietary exposure:

 The most recent acute and chronic aggreg ate dietary (food and drinking water) risk assessments for cyfluthrin and beta -cyfluthrin used the Dietar y Exposure Evaluation Model (DEEM-FCIDTM Version 2.03). This model incorporates consumption data from the USDA’s Continuing Survey of Food Intake s by Individuals taken between 1994 and 1996 along with a supplemental children’s survey taken in 1998. The acute and chronic dietary

risk assessments were both refine d and risks were not of concern.

Residential and Recreational exposure and Risk:

 All residential exposure assessments for cyfluthrin and beta -cyfluthrin were conducted using the 1997 version of HED’s Residential Exposure SOPs for residential exposure assessment,

and there were no risks of concern. The resi dential assessments combined the two potential residential exposure scenarios (indoor carpet and outdoor lawn) for a single worst-case residential exposure component.

A ggregate Risk:

 In the 2007 risk assessment performed for cyfluthrin and beta -cyfluthrin, EPA determined that acute, short-term, intermediate-term, and chronic aggregate risk assessments were appropriate and risks were not of concern. Ac ute and chronic aggregat e risks included food and water, while short-term and intermediate -term aggregate risk included food, water, and residential exposures. For both short-term a nd intermediate-term scenarios, EPA estimated aggregate risks to the general U.S. population, in fants (< 1 year), and children (1 – 2 years).16 Occupational Risk:

 In 2002, occupational handler and post-application dermal/inhalation exposures were assessed for the use of cyfluthrin on a variety of agricultural crops (vegetable crops, field crops, etc.) and grain storage uses. In 2007, occupational risks to workers engaged in production of alfalfa and grasses as well as ri sk to workers engaged in seed treatment operations were assessed. Baseline PPE and a dditional PPE (i.e., chemical resistant gloves and a dust/mist respirator) were recommended based on risk findings.

Cumulative assessment:

Cyfluthrin and beta -cyfluthrin are members of th e pyrethroid class of insec ticides. This class also includes permethrin, cypermethrin, bifenthrin, tau-fluvalin ate, bifenthrin, fenpr opathrin, 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 pyr ethrins and pyrethroids, draft, May 19, 2009; http://www.regulations.gov/search/R egs/hom e.html#documentDetail?R=09000064809a62df ). This document was supported by the FIFRA Scientific A dvisory Panel (SAP) and is available in the

docket ( http://www.regulations.gov/search/R egs/hom e.html#documentDetail?R=0900006480a1f8d7 ). EPA will finalize the policy document on the pyrethroi d common mechanism of toxicity taking into

account the SAP comments. Pe sticides with a common mechanism of toxicity are subject to

cumulative risk assessment under th e FQPA. Research is on-going by EPA’s Office of Research and Development (ORD) to make improvements to the Stochastic Huma n Exposure and Dose Simulation (SHEDS) probabilistic exposure model, which are important for the cumulative risk assessment. EPA ORD is also developing physiol ogically-based pharmacokinetic models for several pyrethroids. The status of both of these research modeling effort s was the subject of a FIFRA SAP held 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.htm l

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Human Studies:

Past cyfluthrin risk assessments re ly in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to ma ny different pesticides, compri se generic pesticide exposure databases such as the Pesticide Handlers Exposur e Database (PHED) and th e Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporti ng these multi-pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or signi ficantly deficient relative to the ethical standards prevailing at the time the research was conducted. All applicable requirements of EPA’s Rule for

the Protection of Human S ubjects of Research (40 CF R Part 26) have been satisfied, and there is no regulatory barrier to conti nued reliance on these studies.17 Incidents

Ecological:

 A preliminary review of the Ec ological Incident Informati on System (EIIS, version 2.1), which is maintained by the Agency’s Office of Pesticide Programs indicates reported ecological incidents associated w ith the use of cyfluthrin and beta -cyfluthrin. A search for incidents involving cyfluthrin and beta -cyfluthrin was also conducte d in the American Bird Conservancy’s Avian Incident Monitoring System (AIMS).

 A total of eight reported ecologi cal incidents have been repo rted to the Agency. These reports did not make distinctions between cyfluthrin and beta -cyfluthrin. This is likely due to the fact that analytical methods used were unable to distinguish cyfluthrin from beta

cyfluthrin. Therefore, cyfluthrin inci dents cannot be ruled out as possible beta -cyfluthrin

incidents.

 Five incidents were reported for aquatic animals and three were reported for terrestrial plants. All incidents were reported between 1993 and 2005. Four of the incidents were associated with registered uses of cyfluthrin, two were associated with uses where it was undetermined if the use was a registered use, and two incidents were associated with misuse.

Human Health:

 Both the OPP Incident Data System (IDS ) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (C DC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were

consulted.

 In general, incidents involving cyfluthrin were of low, moderate and high severity; the most frequently reported symptoms were relate d to the dermal, resp iratory, neurological, gastrointestinal, and ocular systems. The majority of cases involve d subject exposure at home while applying the product indoors or outdoors; however there were cases that occurred in occupational settings while mixi ng, loading, applying, or reentering the treated fields, as well as inadverten t exposure to bystanders.

 For cyfluthrin (PC Code 128831), 274 cases were identified between 2002 and 2009. The incidents appear to be decreasing over ti me. The number of incidents in 2009 is approximately 1/3 of the number reported in 2002. Cyfluthrin incidents occurred both indoors and outdoors, and as a result of applying a produc t or being exposed after application. Many incidents appeared to occur due to misuse such as failure to read the labels, failure to use protective clothing and ma sk, lack of awareness of adverse effects, overuse of a product, failure to ventilate, or a leak/spill resulti ng in direct contact.

 For beta -cyfluthrin (PC Code 118831), 112 cases were identified between 2002 and 2009. The incident trend appears to be increasing.

Tolerances and International Harmonization18 Where possible, EPA strives to harmonize the US Tolerances and Maximum Residue Limits (MRLs) in key export markets. A table with US tolera nces, Canada MRLs, Mexico MRLs and Codex MRLs for cyfluthrin and beta -cyfluthrin in registered raw agricultural commodities is provided in

Attachment 6 of the Cyfluthrin and beta-cyfluthrin Human Health Assessment Scoping Document in Support of Registration Review (July 1, 2010).

For both cyfluthrin and beta -cyfluthrin, Mexico adopts U.S. tole rances and/or Codex MRLs for its
export purposes.

Both Codex and Canada have established MRLs for cyfluthrin. In most cases, the Codex and

Canadian MRLs differ from each other as well as from the U.S. tolerance. Canada has not

established MRLs for beta -cyfluthrin. The Codex MRLs for beta -cyfluthrin are equivalent to the Codex MRLs for cyfluthrin. In most cases , they differ from the U.S. tolerances.

In registration review, the Agency will reconsider the U.S. tolerances and will harmonize them with

Codex MRLs when the data warrant harmonization.

Data Call-In Status

 There have been no data call-ins associated with cyfluthrin or beta -cyfluthrin.

Labels

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

.19 III. Summary of Data Gaps – Cyfluthrin and Beta -cyfluthrin

The tables below summarize all outsta nding data needs for cyfluthrin and beta -cyfluthrin in Section I of this document (Preliminary Work Plan).

Anticipated Data Require ments for Cyfluthrin

Guideline

Number Data Requirement Test

Material Estimated

Timeframe

(Months)

835.1230 Leaching and Adso rption/Desorption TGAI 12

835.4100 Aerobic Soil Metabolism 1 TGAI 24

835.4200 Anaerobic Soil Metabolism 2 TGAI 24

835.6100 (footnote 7 3 ) Environmental Chemistry Method and Independent Laboratory Validation – soil TGAI 24+12

835.6200 (footnote 7 4 ) Environmental Chemistry Method and Independent Laboratory Validation – water and sediment TGAI 24+12

850.2100 Avian Oral Toxicity (passerine species) TGAI 12

850.2300 Avian Reproduction Study (Mallard duck only) TGAI 24

850.1025 Oyster Acute Toxicity, TEP 12

850.1035 Acute Toxicity Estuarine/Marine Organisms – Mysid TEP 12

850.4100 &

850.4150 Seedling Emergence & Vegetative Vigor (Tier II 5 ) TEP 12

850.4400 Aquatic Plant Growth (aquatic vascular plant toxicity) (Tier II 6 ) TGAI 12

Non-GDLN Aquatic Invertebrate Acut e Toxicity (Hyalella azteca) TGAI 12

850.1790 Whole sediment: chronic inve rtebrates freshwater and

marine TGAI 12

Non-GDLN Leachability from Treated Wood TGAI 12

Non-GDLN POTW Effluent Monitoring TGAI 12

Non-GDLN POTW Treat ability Study TGAI 12

870.7800 Immunotoxicity Study TGAI 12

1 Two additional soil studies are expect ed to be required for cyfluthrin.

2 Four additional soil studies are expected to be required.

3 40 CFR Part 158 Guideline Study 835.6100 and 835.6200 Footnote 7 states “Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory me thod trial by an independent labor atory. Test standards and proc edures for independent laboratory validation are available as addenda to the guideline for this test requirement.”

4 40 CFR Part 158 Guideline Study 835.6100 and 835.6200 Footnote 7 states “Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory me thod trial by an independent labor atory. Test standards and proc edures for independent laboratory validation are available as addenda to the guideline for this test requirement.”

5 Registrants may opt to conduct a Tier I study, with the understandi ng that any adverse effects (even if <25%) may necessitate a Tier II study. A Tier II study will enable the Agency to conduct an endangered species assessment for nontarget plants.

6 Registrants may opt to conduct a Tier I study, with the understandi ng that any adverse effects (even if <25%) may necessitate a Tier II study. A Tier II study will enable the Agency to conduct an endangered species assessment for nontarget plants.20 Anticipated Data Requirements for Beta- cyfluthrin

Guideline

Number Data Requirement Test

Material Estimated

Timeframe

(Months)

835.4100 Aerobic Soil Metabolism 1 TGAI 24

835.4300 Aerobic Aquatic Metabolism 2 TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

835.6100 (footnote 7 3 ) Environmental Chemistry Method and Independent Laboratory Validation – soil TGAI 24+12

835.6200 (footnote 7 4 ) Environmental Chemistry Method and Independent Laboratory Validation – water and sediment TGAI 24+12

850.1350 Invertebrate Life Cycle, mysid TGAI 12

850.4100 &

850.4150 Seedling Emergence & Vegetative Vigor (Tier II) TEP 12

850.4400 Aquatic Plant Growth , Lemna gibba TGAI 12

1 One additional sediment study is expected to be required for beta -cyfluthrin

2 One additional sediment study is expected to be required for beta -cyfluthrin

3 40 CFR Part 158 Guideline Study 835.6100 and 835.6200 Footnote 7 states “Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory me thod trial by an independent labor atory. Test standards and proc edures for independent laboratory validation are available as addenda to the guideline for this test requirement.”

4 40 CFR Part 158 Guideline Study 835.6100 and 83 5.6200 Footnote 7 states “Environmental ch emistry methods used to generate data associated with this study must include results of a successful confirmatory me thod trial by an independent labor atory. Test standards and proc edures for independent laboratory validation are available as addenda to the guideline for this test requirement.”